Apparatus And Methods For Bone Access And Cavity Preparation

  *US09848889B2*
  US009848889B2                                 
(12)United States Patent(10)Patent No.: US 9,848,889 B2
  et al. (45) Date of Patent:Dec.  26, 2017

(54)Apparatus and methods for bone access and cavity preparation 
    
(75)Inventor: Conventus Orthopaedics, Inc.,  Maple Grove, MN (US) 
(73)Assignee:Conventus Orthopaedics, Inc.,  Maple Grove, MN (US), Type: US Company 
(*)Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days. 
(21)Appl. No.: 14/929,757 
(22)Filed: Nov.  2, 2015 
(65)Prior Publication Data 
 US 2016/0066926 A1 Mar.  10, 2016 
 Related U.S. Patent Documents 
(63) .
Continuation of application No. 14/594,482, filed on Jan.  12, 2015 , which is a continuation of application No. 13/009,657, filed on Jan.  19, 2011, now Pat. No. 8,961,518 .
 
(60)Provisional application No. 61/296,722, filed on Jan.  20, 2010.
 
 Provisional application No. 61/389,507, filed on Oct.  4, 2010.
 
Jan.  1, 2013 A 61 B 17 1604 F I Dec.  26, 2017 US B H C Jan.  1, 2013 A 61 B 17 164 L I Dec.  26, 2017 US B H C Jan.  1, 2013 A 61 B 17 1617 L I Dec.  26, 2017 US B H C Jan.  1, 2013 A 61 B 17 1637 L I Dec.  26, 2017 US B H C Jan.  1, 2013 A 61 B 17 1703 L A Dec.  26, 2017 US B H C Jan.  1, 2013 A 61 B 17 1725 L A Dec.  26, 2017 US B H C Nov.  1, 2016 A 61 B 17 1782 L A Dec.  26, 2017 US B H C
(51)Int. Cl. A61B 017/16 (20060101); A61B 017/17 (20060101)

 
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 6,302,915  B1  10/2001    Cooney et al.     
 6,306,141  B1  10/2001    Jervis     
 6,312,467  B1  11/2001    Mcgee     
 6,319,255  B1  11/2001    Grundei et al.     
 6,322,591  B1  11/2001    Ahrens     
 6,331,166  B1  12/2001    Burbank et al.     
 6,332,885  B1  12/2001    Martella     
 6,332,886  B1  12/2001    Green et al.     
 6,337,142  B2  1/2002    Harder et al.     
 6,348,053  B1  2/2002    Cachia     
 6,364,909  B1  4/2002    Mcgee     
 6,365,555  B1  4/2002    Moser et al.     
 6,375,666  B1  4/2002    Mische     
 6,383,188  B2  5/2002    Kuslich et al.     
 6,402,753  B1  6/2002    Cole et al.     
 6,411,729  B1  6/2002    Grunkin     
 6,416,517  B2  7/2002    Harder et al.     
 6,423,070  B1  7/2002    Zeppelin     
 6,440,138  B1  8/2002    Reiley et al.     
 6,447,514  B1  9/2002    Stalcup et al.     
 6,447,515  B1  9/2002    Meldrum     
 6,447,518  B1  9/2002    Krause et al.     
 6,454,810  B1  9/2002    Lob     
 6,468,207  B1  10/2002    Fowler     
 6,475,789  B1  11/2002    Cech et al.     
 6,488,685  B1  12/2002    Manderson     
 6,491,694  B1  12/2002    Orsak     
 6,511,481  B2  1/2003    von Hoffmann et al.     
 6,517,541  B1  2/2003    Sesic     
 6,527,775  B1  3/2003    Warburton     
 6,533,788  B1  3/2003    Orbay     
 6,540,770  B1  4/2003    Tornier et al.     
 6,544,267  B1  4/2003    Cole et al.     
 6,551,321  B1  4/2003    Burkinshaw et al.     
 6,554,833  B2  4/2003    Levy et al.     
 6,575,878  B1  6/2003    Choy     
 6,575,973  B1  6/2003    Shekalim     
 6,575,978  B2  6/2003    Peterson et al.     
 6,582,467  B1  6/2003    Teitelbaum et al.     
 6,585,736  B2  7/2003    Hajianpour     
 6,585,770  B1  7/2003    White et al.     
 6,610,839  B1  8/2003    Morin et al.     
 6,613,052  B1  9/2003    Kinnett     
 6,613,054  B2  9/2003    Scribner et al.     
 6,617,110  B1  9/2003    Cech et al.     
 6,632,224  B2  10/2003    Cachia et al.     
 6,641,616  B1  11/2003    Grundei     
 6,645,210  B2  11/2003    Manderson     
 6,648,890  B2  11/2003    Culbert et al.     
 6,652,585  B2  11/2003    Lange     
 6,656,187  B1  12/2003    Camino     
 6,656,219  B1  12/2003    Wiktor     
 6,660,009  B1  12/2003    Azar     
 6,660,041  B1  12/2003    Grundei     
 6,676,665  B2*1/2004    Foley 600/201
 6,679,886  B2  1/2004    Weikel et al.     
 6,682,565  B1  1/2004    Krishnan     
 6,685,706  B2  2/2004    Padget et al.     
 6,689,138  B2  2/2004    Léchot et al.     
 6,692,496  B1  2/2004    Wardlaw     
 6,701,174  B1  3/2004    Krause et al.     
 6,709,433  B1  3/2004    Schoenefeld     
 6,711,432  B1  3/2004    Krause et al.     
 6,712,073  B2  3/2004    Manderson     
 6,712,858  B1  3/2004    Grungei et al.     
 6,719,761  B1  4/2004    Reiley et al.     
 6,719,793  B2  4/2004    McGee et al.     
 6,740,090  B1  5/2004    Cragg et al.     
 6,746,451  B2  6/2004    Middleton et al.     
 6,749,611  B2  6/2004    Venturini et al.     
 6,755,831  B2  6/2004    Putnam et al.     
 6,755,862  B2  6/2004    Keynan     
 6,761,722  B2  7/2004    Cole et al.     
 6,767,350  B1  7/2004    Lob     
 6,775,401  B2  8/2004    Hwang et al.     
 6,780,185  B2  8/2004    Frei et al.     
 6,783,530  B1  8/2004    Levy et al.     
 6,783,532  B2  8/2004    Steiner et al.     
 6,783,533  B2  8/2004    Green et al.     
 6,793,655  B2  9/2004    Orsak     
 6,793,659  B2  9/2004    Putnam     
 6,811,568  B2  11/2004    Minamikawa     
 6,827,723  B2  12/2004    Carson     
 6,827,743  B2  12/2004    Eisermann et al.     
 6,849,051  B2  2/2005    Sramek et al.     
 6,852,128  B2  2/2005    Lange     
 6,866,665  B2  3/2005    Orbay     
 6,887,243  B2  5/2005    Culbert     
 6,890,333  B2  5/2005    von Hoffmann et al.     
 6,893,444  B2  5/2005    Orbay     
 6,908,465  B2  6/2005    von Hoffmann et al.     
 6,911,046  B2  6/2005    Schulter     
 6,913,605  B2  7/2005    Fletcher et al.     
 6,923,813  B2  8/2005    Phillips et al.     
 6,923,817  B2  8/2005    Carson et al.     
 6,923,828  B1  8/2005    Wiktor     
 6,926,720  B2  8/2005    Castañeda     
 6,932,086  B1  8/2005    Hajianpour     
 6,942,666  B2  9/2005    Overaker et al.     
 6,942,668  B2  9/2005    Padget et al.     
 6,949,101  B2  9/2005    McCleary et al.     
 6,951,561  B2  10/2005    Warren et al.     
 6,953,313  B2  10/2005    Tylosky     
 6,975,894  B2  12/2005    Wehrli et al.     
 6,984,248  B2  1/2006    Hyde, Jr.     
 6,986,771  B2  1/2006    Paul et al.     
 6,989,011  B2  1/2006    Paul et al.     
 6,991,656  B2  1/2006    Mears     
 7,008,425  B2  3/2006    Phillips     
 7,008,428  B2  3/2006    Cachia et al.     
 7,008,430  B2  3/2006    Dong et al.     
 7,011,662  B2  3/2006    Lechot et al.     
 7,018,332  B1  3/2006    Masson et al.     
 7,018,380  B2  3/2006    Cole     
 7,022,069  B1  4/2006    Masson et al.     
 7,025,789  B2  4/2006    Chow et al.     
 7,041,104  B1  5/2006    Cole et al.     
 7,041,138  B2  5/2006    Lange     
 7,048,542  B2  5/2006    Von Arx et al.     
 7,052,498  B2  5/2006    Levy et al.     
 7,063,701  B2  6/2006    Michelson     
 7,070,601  B2  7/2006    Culbert et al.     
 7,090,676  B2  8/2006    Huebner et al.     
 7,097,646  B2  8/2006    Schantz     
 7,097,648  B1  8/2006    Globerman et al.     
 7,122,033  B2  10/2006    Wood     
 7,122,043  B2  10/2006    Greenhalgh et al.     
 7,122,052  B2  10/2006    Greenhalgh     
 7,131,995  B2  11/2006    Biedermann et al.     
 7,137,987  B2  11/2006    Patterson et al.     
 7,141,054  B2  11/2006    Vandewalle     
 7,141,067  B2  11/2006    Jones et al.     
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 7,153,307  B2  12/2006    Scribner et al.     
 7,153,309  B2  12/2006    Huebner et al.     
 7,160,302  B2  1/2007    Warburton     
 7,160,331  B2  1/2007    Cooney et al.     
 7,172,595  B1  2/2007    Goble     
 7,175,625  B2  2/2007    Culbert     
 7,179,024  B2  2/2007    Greenhalgh     
 7,189,237  B2  3/2007    Huebner     
 7,189,240  B1  3/2007    Dekel     
 7,195,589  B1  3/2007    Masson et al.     
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 7,267,678  B2  9/2007    Medoff     
 7,282,053  B2  10/2007    Orbay     
 7,294,130  B2  11/2007    Orbay     
 7,300,449  B2  11/2007    Mische et al.     
 7,306,603  B2  12/2007    Boehm et al.     
 7,306,683  B2  12/2007    Cheung et al.     
 7,311,711  B2  12/2007    Cole     
 D560,128  S  1/2008    Diederich et al.     
 7,322,938  B2  1/2008    Burbank et al.     
 7,326,249  B2  2/2008    Lange     
 7,329,228  B2  2/2008    Burbank et al.     
 7,341,601  B2  3/2008    Eisermann et al.     
 7,344,539  B2  3/2008    Serhan et al.     
 7,354,453  B2  4/2008    McAfee     
 7,422,360  B2  9/2008    Kozyuk     
 7,465,318  B2  12/2008    Sennett et al.     
 7,476,226  B2  1/2009    Weikel et al.     
 7,481,815  B2  1/2009    Fernandez     
 7,485,119  B2  2/2009    Thelen et al.     
 7,488,320  B2  2/2009    Middleton     
 7,488,329  B2  2/2009    Thelen et al.     
 D589,147  S  3/2009    Colleran et al.     
 7,500,977  B2  3/2009    Assell et al.     
 7,507,241  B2  3/2009    Levy et al.     
 7,520,879  B2  4/2009    Justis et al.     
 7,527,632  B2  5/2009    Houghton et al.     
 7,563,263  B2  7/2009    Orbay et al.     
 7,569,061  B2  8/2009    Colleran     
 7,578,824  B2  8/2009    Justin et al.     
 7,588,575  B2  9/2009    Colleran et al.     
 7,588,577  B2  9/2009    Fencl et al.     
 7,588,588  B2  9/2009    Spitler et al.     
 7,601,152  B2  10/2009    Levy et al.     
 7,611,515  B2  11/2009    Wolford et al.     
 7,621,950  B1  11/2009    Globerman et al.     
 7,632,277  B2  12/2009    Woll et al.     
 7,632,310  B2  12/2009    Clifford et al.     
 7,666,226  B2  2/2010    Schaller     
 7,670,339  B2  3/2010    Levy et al.     
 7,670,374  B2  3/2010    Schaller     
 7,670,375  B2  3/2010    Schaller     
 7,682,364  B2  3/2010    Reiley et al.     
 7,695,471  B2  4/2010    Cheung et al.     
 7,695,502  B2  4/2010    Orbay et al.     
 7,704,251  B2  4/2010    Huebner et al.     
 7,708,742  B2  5/2010    Scribner et al.     
 7,713,271  B2  5/2010    Warburton et al.     
 7,717,472  B2  5/2010    Johnson     
 7,722,612  B2  5/2010    Sala et al.     
 7,722,626  B2  5/2010    Middleman et al.     
 7,727,264  B2  6/2010    Orbay et al.     
 7,731,720  B2  6/2010    Sand et al.     
 7,749,232  B2  7/2010    Salerni     
 7,758,500  B2  7/2010    Boyd et al.     
 7,785,368  B2  8/2010    Schaller     
 7,806,929  B2  10/2010    Brown     
 7,811,291  B2  10/2010    Liu et al.     
 7,828,802  B2  11/2010    Levy et al.     
 7,837,612  B2  11/2010    Gill et al.     
 7,842,041  B2  11/2010    Liu et al.     
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 7,879,103  B2  2/2011    Gertzman et al.     
 7,905,909  B2  3/2011    Orbay et al.     
 7,909,825  B2  3/2011    Saravia et al.     
 7,909,827  B2  3/2011    Reiley et al.     
 7,909,873  B2  3/2011    Tan-Malecki et al.     
 7,914,533  B2  3/2011    Nelson et al.     
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 7,959,638  B2  6/2011    Osorio et al.     
 7,959,683  B2  6/2011    Semler et al.     
 7,967,827  B2  6/2011    Osorio et al.     
 7,967,865  B2  6/2011    Schaller     
 7,972,340  B2  7/2011    Sand et al.     
 7,988,735  B2  8/2011    Yurek et al.     
 8,007,498  B2  8/2011    Mische     
 RE42,757  E  9/2011    Kuslich et al.     
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 8,021,366  B2  9/2011    Phan     
 8,043,334  B2  10/2011    Fisher et al.     
 8,057,544  B2  11/2011    Schaller     
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 8,109,933  B2  2/2012    Truckai et al.     
 8,114,084  B2  2/2012    Betts     
 8,118,952  B2  2/2012    Gall et al.     
 8,128,627  B2  3/2012    Justin et al.     
 8,152,737  B2  4/2012    Burbank et al.     
 8,157,804  B2  4/2012    Betts     
 8,226,719  B2  7/2012    Melsheimer et al.     
 8,241,335  B2  8/2012    Truckai et al.     
 8,287,538  B2  10/2012    Brenzel et al.     
 8,287,539  B2  10/2012    Nelson et al.     
 8,287,541  B2  10/2012    Nelson et al.     
 8,317,791  B2  11/2012    Phan     
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 8,366,773  B2  2/2013    Schaller et al.     
 8,409,211  B2  4/2013    Baroud     
 8,430,879  B2  4/2013    Stoneburner et al.     
 8,439,917  B2  5/2013    Saravia et al.     
 8,485,798  B2  7/2013    Sheth et al.     
 8,491,591  B2  7/2013    Fürderer     
 8,496,394  B2  7/2013    Schneider     
 8,496,657  B2  7/2013    Bonutti et al.     
 8,496,658  B2  7/2013    Stoneburner et al.     
 8,512,398  B2  8/2013    Alkhatib     
 8,568,413  B2  10/2013    Mazur et al.     
 8,579,537  B2  11/2013    VanLandingham et al.     
 8,597,276  B2  12/2013    Vongphakdy et al.     
 8,906,022  B2  12/2014    Krinke et al.     
 8,951,251  B2*2/2015    Willard 606/41
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 9,155,574  B2  10/2015    Saravia et al.     
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 2001//0053912  A1  12/2001    Frigg     
 2002//0013600  A1  1/2002    Scribner et al.     
 2002//0015517  A1  2/2002    Hwang et al.     
 2002//0029081  A1  3/2002    Scarborough et al.     
 2002//0032444  A1  3/2002    Mische     
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 2002//0055785  A1  5/2002    Harris     
 2002//0065530  A1  5/2002    Mische     
 2002//0068974  A1  6/2002    Kuslich et al.     
 2002//0111629  A1  8/2002    Phillips     
 2002//0111690  A1  8/2002    Hyde     
 2002//0120269  A1  8/2002    Lange     
 2002//0120270  A1  8/2002    Trieu et al.     
 2002//0123750  A1  9/2002    Eisermann et al.     
 2002//0133153  A1  9/2002    Hyde     
 2002//0133156  A1  9/2002    Cole     
 2002//0133172  A1  9/2002    Lambrecht et al.     
 2002//0133175  A1  9/2002    Carson     
 2002//0138149  A1  9/2002    Hyde     
 2002//0143329  A1  10/2002    Serhan et al.     
 2002//0143333  A1  10/2002    von Hoffmann et al.     
 2002//0143334  A1  10/2002    Hoffmann et al.     
 2002//0143335  A1  10/2002    von Hoffmann et al.     
 2002//0147451  A1  10/2002    Mcgee     
 2002//0147455  A1  10/2002    Carson     
 2002//0165461  A1  11/2002    Hayzelden et al.     
 2002//0171208  A1  11/2002    Lechot et al.     
 2002//0173813  A1  11/2002    Peterson et al.     
 2002//0183758  A1  12/2002    Middleton et al.     
 2002//0191823  A1  12/2002    Wehrli et al.     
 2003//0040805  A1  2/2003    Minamikawa     
 2003//0055373  A1  3/2003    Sramek et al.     
 2003//0055425  A1  3/2003    Hajianpour     
 2003//0069582  A1  4/2003    Culbert     
 2003//0069645  A1  4/2003    Ball et al.     
 2003//0074075  A1  4/2003    Thomas, Jr. et al.     
 2003//0083660  A1  5/2003    Orbay     
 2003//0083662  A1  5/2003    Middleton     
 2003//0093076  A1  5/2003    Venturini et al.     
 2003//0097132  A1  5/2003    Padget et al.     
 2003//0097133  A1  5/2003    Green et al.     
 2003//0105461  A1  6/2003    Putnam     
 2003//0109932  A1  6/2003    Keynan     
 2003//0120273  A1  6/2003    Cole     
 2003//0130660  A1  7/2003    Levy et al.     
 2003//0153918  A1  8/2003    Putnam et al.     
 2003//0187449  A1  10/2003    McCleary et al.     
 2003//0216738  A1  11/2003    Azar     
 2003//0220641  A1  11/2003    Thelen et al.     
 2003//0220644  A1  11/2003    Thelen et al.     
 2003//0220646  A1  11/2003    Thelen et al.     
 2003//0220698  A1  11/2003    Mears et al.     
 2003//0225407  A1  12/2003    Estrada     
 2004//0024410  A1  2/2004    Olson, Jr. et al.     
 2004//0039384  A1  2/2004    Boehm et al.     
 2004//0044413  A1  3/2004    Schulter     
 2004//0049192  A1  3/2004    Shimizu     
 2004//0078082  A1  4/2004    Lange     
 2004//0087956  A1  5/2004    Weikel et al.     
 2004//0092946  A1  5/2004    Bagga et al.     
 2004//0102777  A1  5/2004    Huebner     
 2004//0102778  A1  5/2004    Huebner et al.     
 2004//0102788  A1  5/2004    Huebner et al.     
 2004//0106925  A1  6/2004    Culbert     
 2004//0138665  A1  7/2004    Padget et al.     
 2004//0143264  A1  7/2004    McAfee     
 2004//0153080  A1  8/2004    Dong et al.     
 2004//0153114  A1  8/2004    Reiley et al.     
 2004//0153115  A1  8/2004    Reiley et al.     
 2004//0167528  A1  8/2004    Schantz     
 2004//0167625  A1  8/2004    Beyar et al.     
 2004//0181221  A1  9/2004    Huebner et al.     
 2004//0193163  A1  9/2004    Orbay     
 2004//0193164  A1  9/2004    Orbay     
 2004//0193165  A1  9/2004    Orbay     
 2004//0193251  A1  9/2004    Rudnick et al.     
 2004//0193267  A1  9/2004    Jones et al.     
 2004//0208717  A1  10/2004    Greenhalgh     
 2004//0214311  A1  10/2004    Levy     
 2004//0220678  A1  11/2004    Chow et al.     
 2004//0230193  A1  11/2004    Cheung et al.     
 2004//0236327  A1  11/2004    Paul et al.     
 2004//0236328  A1  11/2004    Paul et al.     
 2004//0236339  A1  11/2004    Pepper     
 2004//0249375  A1  12/2004    Agee et al.     
 2004//0260289  A1  12/2004    Padget et al.     
 2004//0260297  A1  12/2004    Padget et al.     
 2004//0267269  A1  12/2004    Middleton et al.     
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 2005//0015154  A1  1/2005    Lindsey et al.     
 2005//0033366  A1  2/2005    Cole et al.     
 2005//0043733  A1  2/2005    Eisermann et al.     
 2005//0065522  A1  3/2005    Orbay     
 2005//0065523  A1  3/2005    Orbay     
 2005//0065524  A1  3/2005    Orbay     
 2005//0065526  A1  3/2005    Drew et al.     
 2005//0070902  A1  3/2005    Medoff     
 2005//0085813  A1  4/2005    Spitler et al.     
 2005//0085818  A1  4/2005    Huebner     
 2005//0085824  A1  4/2005    Castaneda     
 2005//0085921  A1  4/2005    Gupta et al.     
 2005//0113836  A1*5/2005    Lozier 606/80
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 2005//0113929  A1  5/2005    Cragg et al.     
 2005//0119749  A1  6/2005    Lange     
 2005//0124972  A1  6/2005    Mische et al.     
 2005//0125066  A1  6/2005    Mcafee     
 2005//0131407  A1  6/2005    Sicvol et al.     
 2005//0142163  A1  6/2005    Hunter et al.     
 2005//0143734  A1  6/2005    Cachia et al.     
 2005//0154331  A1  7/2005    Christie et al.     
 2005//0159749  A1  7/2005    Levy et al.     
 2005//0177172  A1  8/2005    Acker et al.     
 2005//0182399  A1  8/2005    Levine     
 2005//0192578  A1  9/2005    Horst     
 2005//0197537  A1  9/2005    Bonadio et al.     
 2005//0209557  A1  9/2005    Carroll et al.     
 2005//0216000  A1  9/2005    Colleran et al.     
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 2005//0216008  A1  9/2005    Zwirnmann et al.     
 2005//0228391  A1  10/2005    Levy et al.     
 2005//0234472  A1  10/2005    Huebner     
 2005//0240188  A1  10/2005    Chow et al.     
 2005//0240190  A1  10/2005    Gall et al.     
 2005//0240193  A1  10/2005    Layne et al.     
 2005//0245928  A1  11/2005    Colleran et al.     
 2005//0251142  A1  11/2005    Hoffmann et al.     
 2005//0261779  A1  11/2005    Meyer     
 2005//0267483  A1  12/2005    Middleton     
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 2005//0277936  A1  12/2005    Siravo et al.     
 2005//0277978  A1  12/2005    Greenhalgh     
 2005//0283154  A1  12/2005    Orbay et al.     
 2005//0283159  A1  12/2005    Amara     
 2005//0288676  A1  12/2005    Schnieders et al.     
 2005//0288795  A1  12/2005    Bagga et al.     
 2006//0002980  A1  1/2006    Ringeisen et al.     
 2006//0004362  A1  1/2006    Patterson et al.     
 2006//0004462  A1  1/2006    Gupta     
 2006//0009771  A1  1/2006    Orbay et al.     
 2006//0015123  A1  1/2006    Fencl et al.     
 2006//0036240  A1  2/2006    Colleran et al.     
 2006//0036244  A1  2/2006    Spitler et al.     
 2006//0047787  A1  3/2006    Agarwal et al.     
 2006//0052788  A1  3/2006    Thelen et al.     
 2006//0058621  A1  3/2006    Wehrli et al.     
 2006//0058826  A1  3/2006    Evans et al.     
 2006//0064005  A1  3/2006    Triano et al.     
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 2006//0064164  A1  3/2006    Thelen et al.     
 2006//0064173  A1  3/2006    Guederian et al.     
 2006//0069392  A1  3/2006    Renzi Brivio et al.     
 2006//0079894  A1  4/2006    Colleran et al.     
 2006//0079905  A1  4/2006    Beyar et al.     
 2006//0085009  A1  4/2006    Truckai et al.     
 2006//0089647  A1  4/2006    Culbert et al.     
 2006//0089648  A1  4/2006    Masini     
 2006//0100631  A1  5/2006    Sullivan et al.     
 2006//0100706  A1  5/2006    Shadduck et al.     
 2006//0106390  A1  5/2006    Jensen et al.     
 2006//0106394  A1  5/2006    Colleran     
 2006//0116773  A1  6/2006    Cooney et al.     
 2006//0122600  A1  6/2006    Cole     
 2006//0122610  A1  6/2006    Culbert et al.     
 2006//0142760  A1  6/2006    McDonnel     
 2006//0142858  A1  6/2006    Colleran et al.     
 2006//0149281  A1  7/2006    Reiley et al.     
 2006//0149379  A1  7/2006    Kuslich et al.     
 2006//0155289  A1  7/2006    Windhager et al.     
 2006//0173454  A1  8/2006    Spitler et al.     
 2006//0178737  A1  8/2006    Furcht et al.     
 2006//0184192  A1  8/2006    Markworth et al.     
 2006//0187748  A1  8/2006    Kozyuk     
 2006//0189994  A1  8/2006    Wolford et al.     
 2006//0195103  A1  8/2006    Padget et al.     
 2006//0200061  A1  9/2006    Warkentine     
 2006//0200140  A1  9/2006    Lange     
 2006//0200143  A1  9/2006    Warburton     
 2006//0217730  A1  9/2006    Termanini     
 2006//0229602  A1  10/2006    Olsen     
 2006//0235264  A1  10/2006    Vassallo     
 2006//0241629  A1  10/2006    Krebs et al.     
 2006//0241630  A1  10/2006    Brunnett et al.     
 2006//0241671  A1  10/2006    Greenhalgh     
 2006//0241776  A1  10/2006    Brown et al.     
 2006//0247637  A1  11/2006    Colleran et al.     
 2006//0264944  A1  11/2006    Cole     
 2006//0264945  A1  11/2006    Edidin et al.     
 2006//0264950  A1  11/2006    Nelson et al.     
 2006//0264951  A1  11/2006    Nelson et al.     
 2006//0264952  A1  11/2006    Nelson et al.     
 2006//0271053  A1  11/2006    Schlapfer et al.     
 2006//0271061  A1  11/2006    Beyar et al.     
 2006//0271198  A1  11/2006    Mcafee     
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 2007//0016188  A1  1/2007    Boehm et al.     
 2007//0016198  A1  1/2007    Boehm et al.     
 2007//0016199  A1  1/2007    Boehm et al.     
 2007//0016211  A1  1/2007    Botimer     
 2007//0016283  A1  1/2007    Greenhalgh et al.     
 2007//0016300  A1  1/2007    Kuslich     
 2007//0027230  A1  2/2007    Beyar et al.     
 2007//0032567  A1  2/2007    Beyar et al.     
 2007//0043373  A1  2/2007    Sala et al.     
 2007//0049936  A1  3/2007    Colleran et al.     
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 2007//0066480  A1  3/2007    Moser et al.     
 2007//0073342  A1  3/2007    Stone et al.     
 2007//0100285  A1  5/2007    Griffin et al.     
 2007//0112427  A1  5/2007    Christy et al.     
 2007//0118132  A1  5/2007    Culbert et al.     
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 2007//0123886  A1  5/2007    Meyer et al.     
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 2007//0123995  A1  5/2007    Thelen et al.     
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 2007//0173835  A1  7/2007    Medoff et al.     
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 2007//0173839  A1  7/2007    Running et al.     
 2007//0173939  A1  7/2007    Kim et al.     
 2007//0179505  A1  8/2007    Culbert     
 2007//0198043  A1  8/2007    Cox et al.     
 2007//0213727  A1  9/2007    Bottlang et al.     
 2007//0219634  A1  9/2007    Greenhalgh et al.     
 2007//0225568  A1  9/2007    Colleran     
 2007//0225721  A1  9/2007    Thelen et al.     
 2007//0225726  A1  9/2007    Dye et al.     
 2007//0225810  A1  9/2007    Colleran et al.     
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 2007//0233105  A1  10/2007    Nelson et al.     
 2007//0244485  A1  10/2007    Greenhalgh et al.     
 2007//0255287  A1  11/2007    Rabiner     
 2007//0270855  A1  11/2007    Partin et al.     
 2007//0276392  A1  11/2007    Beyar et al.     
 2007//0276405  A1  11/2007    Huebner et al.     
 2007//0282443  A1  12/2007    Globerman et al.     
 2007//0283849  A1  12/2007    Edidin et al.     
 2007//0288097  A1  12/2007    Hurowitz     
 2008//0009868  A1  1/2008    Gotfried et al.     
 2008//0009874  A1  1/2008    Meridew et al.     
 2008//0009875  A1*1/2008    Sankaran 606/84
 2008//0009877  A1  1/2008    Sankaran et al.     
 2008//0012317  A1  1/2008    Johnson     
 2008//0015601  A1  1/2008    Castro et al.     
 2008//0019970  A1  1/2008    Gorman     
 2008//0021474  A1  1/2008    Bonutti et al.     
 2008//0039854  A1  2/2008    Rabiner     
 2008//0041629  A1  2/2008    Aronstam et al.     
 2008//0053575  A1  3/2008    Cheung et al.     
 2008//0058804  A1  3/2008    Lechot et al.     
 2008//0065072  A1  3/2008    Spitler et al.     
 2008//0065073  A1  3/2008    Perriello et al.     
 2008//0065074  A1  3/2008    Yeung et al.     
 2008//0065140  A1  3/2008    Bonutti     
 2008//0071356  A1  3/2008    Greenhalgh et al.     
 2008//0077117  A1  3/2008    Miller et al.     
 2008//0077172  A1  3/2008    Miller et al.     
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 2008//0097332  A1  4/2008    Greenhalgh et al.     
 2008//0103501  A1  5/2008    Ralph et al.     
 2008//0103519  A1  5/2008    Bonutti     
 2008//0108996  A1  5/2008    Padget et al.     
 2008//0114364  A1  5/2008    Goldin et al.     
 2008//0119886  A1  5/2008    Greenhalgh et al.     
 2008//0125784  A1  5/2008    Rabiner et al.     
 2008//0125805  A1  5/2008    Mische     
 2008//0132896  A1  6/2008    Bowen et al.     
 2008//0133017  A1  6/2008    Beyar et al.     
 2008//0140078  A1  6/2008    Nelson et al.     
 2008//0140130  A1  6/2008    Chan et al.     
 2008//0149115  A1  6/2008    Hauck et al.     
 2008//0161805  A1  7/2008    Saravia et al.     
 2008//0161825  A1  7/2008    Greenhalgh et al.     
 2008//0167657  A1  7/2008    Greenhalgh     
 2008//0177261  A1  7/2008    Mcminn     
 2008//0183171  A1  7/2008    Elghazaly et al.     
 2008//0194868  A1  8/2008    Kozyuk     
 2008//0195104  A1  8/2008    Sidebotham et al.     
 2008//0195105  A1  8/2008    Sidebotham et al.     
 2008//0200915  A1  8/2008    Globerman et al.     
 2008//0200951  A1  8/2008    Mcafee     
 2008//0208202  A1  8/2008    Williams     
 2008//0208230  A1  8/2008    Chin et al.     
 2008//0208261  A1  8/2008    Medoff     
 2008//0208320  A1  8/2008    Tan-Malecki et al.     
 2008//0212405  A1  9/2008    Globerman et al.     
 2008//0228192  A1  9/2008    Beyar et al.     
 2008//0249436  A1  10/2008    Darr     
 2008//0255560  A1  10/2008    Myers et al.     
 2008//0262495  A1  10/2008    Coati et al.     
 2008//0269742  A1  10/2008    Levy et al.     
 2008//0269745  A1  10/2008    Justin     
 2008//0269746  A1  10/2008    Justin     
 2008//0269747  A1  10/2008    Justin     
 2008//0269748  A1  10/2008    Justin et al.     
 2008//0269749  A1  10/2008    Shalaby et al.     
 2008//0269750  A1  10/2008    Justin     
 2008//0269776  A1  10/2008    Justin et al.     
 2008//0275448  A1  11/2008    Sackett et al.     
 2008//0275449  A1  11/2008    Sackett et al.     
 2008//0287950  A1  11/2008    Frigg et al.     
 2008//0287951  A1  11/2008    Stoneburner et al.     
 2008//0288003  A1  11/2008    McKinley     
 2008//0294163  A1  11/2008    Chou et al.     
 2008//0294166  A1  11/2008    Goldin et al.     
 2008//0294167  A1  11/2008    Schumacher et al.     
 2008//0294169  A1  11/2008    Scott et al.     
 2008//0294205  A1  11/2008    Greenhalgh et al.     
 2008//0319444  A9  12/2008    Osorio et al.     
 2009//0005782  A1  1/2009    Chirico et al.     
 2009//0012522  A1  1/2009    Lob     
 2009//0012564  A1  1/2009    Chirico et al.     
 2009//0018542  A1  1/2009    Saravia et al.     
 2009//0018656  A1  1/2009    Clifford et al.     
 2009//0018666  A1  1/2009    Grundei et al.     
 2009//0024204  A1  1/2009    Greenhalgh et al.     
 2009//0048620  A1  2/2009    Weiss et al.     
 2009//0048629  A1  2/2009    Rabiner     
 2009//0048672  A1  2/2009    Essenmacher     
 2009//0054900  A1  2/2009    Rabiner et al.     
 2009//0076517  A1  3/2009    Reiley et al.     
 2009//0088752  A1  4/2009    Metzinger et al.     
 2009//0104586  A1  4/2009    Cardoso et al.     
 2009//0112196  A1  4/2009    Rabiner et al.     
 2009//0112330  A1  4/2009    Grundei     
 2009//0125028  A1  5/2009    Teisen et al.     
 2009//0131952  A1  5/2009    Schumacher et al.     
 2009//0131992  A1  5/2009    Greenhalgh et al.     
 2009//0138015  A1  5/2009    Conner et al.     
 2009//0143781  A1  6/2009    Mische     
 2009//0143827  A1  6/2009    Levy et al.     
 2009//0149890  A1  6/2009    Martin     
 2009//0149956  A1  6/2009    Greenhalgh et al.     
 2009//0157080  A1  6/2009    Warburton     
 2009//0163918  A1  6/2009    Levy et al.     
 2009//0177206  A1  7/2009    Lozier et al.     
 2009//0177239  A1  7/2009    Castro     
 2009//0216232  A1  8/2009    Buford et al.     
 2009//0228007  A1  9/2009    Justin et al.     
 2009//0228008  A1  9/2009    Justin et al.     
 2009//0275995  A1  11/2009    Truckai et al.     
 2009//0281628  A1  11/2009    Oglaza     
 2009//0292323  A1  11/2009    Chirico et al.     
 2009//0318981  A1  12/2009    Kang     
 2010//0023010  A1  1/2010    Nelson et al.     
 2010//0087821  A1  4/2010    Trip et al.     
 2010//0094292  A1  4/2010    Parrott     
 2010//0094347  A1  4/2010    Nelson et al.     
 2010//0100184  A1  4/2010    Krueger et al.     
 2010//0114181  A1  5/2010    Lob     
 2010//0131019  A1  5/2010    Lob     
 2010//0137862  A1  6/2010    Diao et al.     
 2010//0145397  A1  6/2010    Overes et al.     
 2010//0161061  A1  6/2010    Hunt     
 2010//0222884  A1  9/2010    Greenhalgh     
 2010//0241120  A1  9/2010    Bledsoe et al.     
 2010//0241123  A1  9/2010    Middleton et al.     
 2010//0241176  A1  9/2010    Lob     
 2010//0249785  A1  9/2010    Betts     
 2010//0286481  A1  11/2010    Sharp et al.     
 2010//0286692  A1  11/2010    Greenhalgh et al.     
 2011//0077650  A1  3/2011    Braun et al.     
 2011//0087227  A1  4/2011    Mazur et al.     
 2011//0137313  A1  6/2011    Jensen et al.     
 2011//0144645  A1  6/2011    Saravia et al.     
 2011//0178520  A1  7/2011    Taylor et al.     
 2011//0218585  A1  9/2011    Krinke et al.     
 2011//0282346  A1  11/2011    Pham et al.     
 2011//0295255  A1  12/2011    Roberts et al.     
 2011//0306975  A1  12/2011    Kaikkonen et al.     
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 2011//0307072  A1  12/2011    Anderson et al.     
 2011//0313537  A1  12/2011    Anderson et al.     
 2012//0029633  A1  2/2012    Anderson et al.     
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 2012//0179161  A1  7/2012    Rains et al.     
 2012//0209273  A1  8/2012    Zaretzka et al.     
 2012//0232533  A1  9/2012    Veldman et al.     
 2012//0239038  A1  9/2012    Saravia et al.     
 2012//0253410  A1  10/2012    Taylor et al.     
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 2013//0012942  A1  1/2013    Nelson et al.     
 2013//0116693  A1  5/2013    Nelson et al.     
 2013//0165935  A1  6/2013    Griffiths et al.     
 2013//0231665  A1  9/2013    Saravia et al.     
 2013//0267953  A1  10/2013    Brenzel et al.     
 2014//0031823  A1  1/2014    Mazur et al.     
 2014//0058390  A1  2/2014    Taylor et al.     
 2014//0074093  A9  3/2014    Nelson et al.     
 2014//0088707  A1  3/2014    Donner et al.     
 2014//0128870  A1  5/2014    Brenzel et al.     
 2014//0200618  A1  7/2014    Donner et al.     
 2015//0141996  A1  5/2015    Taylor et al.     
 2015//0164514  A1  6/2015    Wlodarski et al.     
 2015//0320459  A1  11/2015    Brenzel et al.     
 2016//0128703  A1  5/2016    Wlodarski et al.     

 
 FOREIGN PATENT DOCUMENTS 
 
       CA       2007210       A1                11/1990      
       CA       2452508       A1                1/2003      
       CA       2609175       A1                12/2005      
       CA       2537171       C                8/2007      
       CA       2669737       A1                5/2008      
       CA       2670263       A1                5/2008      
       CA       2670438       A1                5/2008      
       CA       2678911       A1                9/2008      
       CA       2685046       A1                11/2008      
       CA       2727453       A1                12/2009      
       CA       2738478       A1                4/2010      
       CN       2326199                         6/1999      
       CN       1530079                         9/2004      
       CN       1533260       A                9/2004      
       CN       2699849       Y                5/2005      
       CN       1909848       A                2/2007      
       CN       100379388                         4/2008      
       CN       101208053       A                6/2008      
       CN       101404946                         4/2009      
       CN       101636119       A                1/2010      
       DE       923085                         7/1949      
       DE       3146065       A1                5/1983      
       DE       3234875       A1                3/1984      
       DE       198800197       U1                8/1988      
       DE       3922044       A1                2/1991      
       DE       4217236                         11/1993      
       DE       202006017194       U1                2/2007      
       DE       102006016213                         10/2007      
       EP       0145166       A2                6/1985      
       EP       145166       A2                6/1985      
       EP       145166       A3                8/1986      
       EP       253526       A1                1/1988      
       EP       263292       A1                4/1988      
       EP       275871       A1                7/1988      
       EP       355035       A2                2/1990      
       EP       381462       A2                8/1990      
       EP       396519       A1                11/1990      
       EP       401650       A1                12/1990      
       EP       409769       A1                1/1991      
       EP       420542       A1                4/1991      
       EP       440371       A1                8/1991      
       EP       442137       A1                8/1991      
       EP       475077       A2                3/1992      
       EP       487669       A1                6/1992      
       EP       491211       A1                6/1992      
       EP       508710       A1                10/1992      
       EP       525352       A1                2/1993      
       EP       611560       A1                8/1994      
       EP       745352       A2                12/1996      
       EP       546162       B1                9/1997      
       EP       807419       A2                11/1997      
       EP       819413       A2                1/1998      
       EP       931513       A2                7/1999      
       EP       0941037                         9/1999      
       EP       0941037       B1                9/1999      
       EP       1099412       A2                5/2001      
       EP       1132051       A2                9/2001      
       EP       674495       B1                11/2001      
       EP       1155661       A1                11/2001      
       EP       1203569       A1                5/2002      
       EP       900065       B1                6/2002      
       EP       1277442       A2                1/2003      
       EP       1300122       A2                4/2003      
       EP       1348384       A2                10/2003      
       EP       1354562                         10/2003      
       EP       1372496       A1                1/2004      
       EP       1391186       A1                2/2004      
       EP       1098600       B1                3/2004      
       EP       1277442       A3                3/2004      
       EP       1396231       A1                3/2004      
       EP       1410765       A2                4/2004      
       EP       1442718       A1                8/2004      
       EP       1442729       A1                8/2004      
       EP       1454592       A2                9/2004      
       EP       1459686       A2                9/2004      
       EP       1484077       A2                12/2004      
       EP       1079752       B1                1/2005      
       EP       1484077       A3                1/2005      
       EP       1495729       A1                1/2005      
       EP       1148825       B1                3/2005      
       EP       1148850       B1                4/2005      
       EP       1522268       A1                4/2005      
       EP       1227765       B1                5/2005      
       EP       1535579       A2                6/2005      
       EP       1563795       A1                8/2005      
       EP       1582159       A1                10/2005      
       EP       1582160       A1                10/2005      
       EP       1582161       A1                10/2005      
       EP       1582162       A1                10/2005      
       EP       1582163       A1                10/2005      
       EP       1582164       A1                10/2005      
       EP       1634548       A2                3/2006      
       EP       1639953       A1                3/2006      
       EP       1669035       A1                6/2006      
       EP       1073371       B1                8/2006      
       EP       1454592       A3                8/2006      
       EP       1700572       A1                9/2006      
       EP       1702572       A2                9/2006      
       EP       1714618       A2                10/2006      
       EP       1787593       A1                5/2007      
       EP       1808143       A1                7/2007      
       EP       1815813       A2                8/2007      
       EP       1820462       A1                8/2007      
       EP       1011464       B1                1/2008      
       EP       1905367       A1                4/2008      
       EP       1905392       A1                4/2008      
       EP       1915959       A2                4/2008      
       EP       1920721       A2                5/2008      
       EP       1923019       A1                5/2008      
       EP       1277442       B1                7/2008      
       EP       1972308       A1                9/2008      
       EP       1987785       A2                11/2008      
       EP       2014261       A1                1/2009      
       EP       2025292       A1                2/2009      
       EP       1459689       B1                4/2009      
       EP       1484077       B1                6/2009      
       EP       1073371       B2                7/2009      
       EP       1459689       B3                11/2009      
       ES       2251888                         5/2006      
       FR       2653006       A1                4/1991      
       FR       2686788                         8/1993      
       FR       2781360                         1/2000      
       FR       2861576                         5/2005      
       GB       2173565       A                10/1986      
       GB       2268068       A                1/1994      
       GB       2274993                         8/1994      
       JP       1310664       A                12/1989      
       JP       2000287983                         10/2000      
       JP       2007125386                         5/2007      
       JP       2008500140       A                1/2008      
       JP       2008540037       A                11/2008      
       JP       2010510040       A                4/2010      
       JP       2010510041       A                4/2010      
       JP       2010510042       A                4/2010      
       JP       2010522046       A                7/2010      
       JP       2010524642       A                7/2010      
       JP       2011523889       A                8/2011      
       JP       2012504027       A                2/2012      
       RU       2004104359       A                2/2005      
       WO       WO89/04150       A1                5/1989      
       WO       WO89/07056       A1                8/1989      
       WO       WO90/03764       A1                4/1990      
       WO       WO90/11726       A1                10/1990      
       WO       WO91/02493       A1                3/1991      
       WO       WO91/06260       A1                5/1991      
       WO       WO91/06265       A1                5/1991      
       WO       WO91/11962       A1                8/1991      
       WO       WO91/19461       A1                12/1991      
       WO       WO99/37219       A1                7/1994      
       WO       WO94/24938       A1                11/1994      
       WO       WO94/27507       A1                12/1994      
       WO       WO94/28824       A2                12/1994      
       WO       WO95/14433       A1                6/1995      
       WO       WO95/14433       A1                6/1995      
       WO       WO95/20362       A1                8/1995      
       WO       WO95/31159       A1                11/1995      
       WO       WO96/02202       A1                2/1996      
       WO       WO96/02203       A1                2/1996      
       WO       WO96/05783       A1                2/1996      
       WO       WO96/06041       A1                2/1996      
       WO       WO96/07161       A1                3/1996      
       WO       WO96/16607       A1                6/1996      
       WO       WO96/17557       A1                6/1996      
       WO       WO96/18354       A2                6/1996      
       WO       WO96/18354       A2                6/1996      
       WO       WO96/18354       A3                8/1996      
       WO       WO96/25118       A1                8/1996      
       WO       WO96/40476       A1                12/1996      
       WO       WO97/03611       A1                2/1997      
       WO       WO97/03611       A1                2/1997      
       WO       WO97/18775       A1                5/1997      
       WO       WO97/42602       A1                11/1997      
       WO       WO97/42912       A1                11/1997      
       WO       WO97/47251       A1                12/1997      
       WO       WO98/01077       A1                1/1998      
       WO       WO98/05261       A2                2/1998      
       WO       WO98/07392       A1                2/1998      
       WO       WO98/19616       A1                5/1998      
       WO       WO98/24380       A1                6/1998      
       WO       WO98/26725       A1                6/1998      
       WO       WO98/38918       A1                9/1998      
       WO       WO98/46169       A1                10/1998      
       WO       WO98/56301       A1                12/1998      
       WO       WO99/22661       A1                5/1999      
       WO       WO99/22662       A1                5/1999      
       WO       WO99/47055       A1                9/1999      
       WO       WO99/51149       A1                10/1999      
       WO       WO99/53843       A1                10/1999      
       WO       WO99/55248       A1                11/1999      
       WO       WO99/62416       A1                12/1999      
       WO       WO00/06037       A1                2/2000      
       WO       WO00/09024       A1                2/2000      
       WO       WO00/12036       A1                3/2000      
       WO       WO00/12036       A1                3/2000      
       WO       WO00/21455       A1                4/2000      
       WO       WO00/25681       A1                5/2000      
       WO       WO00/28906       A1                5/2000      
       WO       WO00/30551       A1                6/2000      
       WO       WO00/30569       A1                6/2000      
       WO       WO00/38586       A1                7/2000      
       WO       WO00/42954       A2                7/2000      
       WO       WO00/44319       A1                8/2000      
       WO       WO00/44321       A2                8/2000      
       WO       WO00/44946       A1                8/2000      
       WO       WO00/45712       A1                8/2000      
       WO       WO00/45714       A1                8/2000      
       WO       WO00/45715       A1                8/2000      
       WO       WO00/45722       A1                8/2000      
       WO       WO00/47119       A1                8/2000      
       WO       WO00/48534       A1                8/2000      
       WO       WO00/71038       A1                11/2000      
       WO       WO00/76414       A1                12/2000      
       WO       WO01/08571       A1                2/2001      
       WO       WO01/28443       A1                4/2001      
       WO       WO01/34045       A1                5/2001      
       WO       WO01/49193       A1                7/2001      
       WO       WO01/54598       A1                8/2001      
       WO       WO01/60268       A1                8/2001      
       WO       WO01/60268       A1                8/2001      
       WO       WO01/76493       A1                10/2001      
       WO       WO01/76514       A2                10/2001      
       WO       WO01/78015       A2                10/2001      
       WO       WO01/80751       A1                11/2001      
       WO       WO01/85042       A1                11/2001      
       WO       WO02/13700       A2                2/2002      
       WO       WO02/13716       A1                2/2002      
       WO       WO02/17794       A1                3/2002      
       WO       WO02/17794       A1                3/2002      
       WO       WO02/24088       A2                3/2002      
       WO       WO02/34107       A2                5/2002      
       WO       WO02/34148       A2                5/2002      
       WO       WO02/37935       A2                5/2002      
       WO       WO02/45606       A1                6/2002      
       WO       WO02/49517       A1                6/2002      
       WO       WO02/058575       A1                8/2002      
       WO       WO02/67824       A2                9/2002      
       WO       WO02/078555       A1                10/2002      
       WO       WO02/089683       A1                11/2002      
       WO       WO02/96306       A1                12/2002      
       WO       WO03/007830       A1                1/2003      
       WO       WO03/013336       A2                2/2003      
       WO       WO02/17794       A8                3/2003      
       WO       WO03/030760       A1                4/2003      
       WO       WO03/043488       A2                5/2003      
       WO       WO03/045257       A2                6/2003      
       WO       WO03/047440       A2                6/2003      
       WO       WO03/068090       A1                8/2003      
       WO       WO02/17794       A9                9/2003      
       WO       WO20/04008949       A2                1/2004      
       WO       WO20/04017817       A2                3/2004      
       WO       WO20/04021904                         3/2004      
       WO       WO20/04030549       A1                4/2004      
       WO       WO20/04039271                         5/2004      
       WO       WO20/04064603       A2                8/2004      
       WO       WO20/04078220       A2                9/2004      
       WO       WO20/04078221       A2                9/2004      
       WO       WO20/04086934       A2                10/2004      
       WO       WO20/04092431       A1                10/2004      
       WO       WO20/04093633       A2                11/2004      
       WO       WO20/04098453       A2                11/2004      
       WO       WO20/04103209       A2                12/2004      
       WO       WO20/04110292       A2                12/2004      
       WO       WO20/04110300       A2                12/2004      
       WO       WO20/04112661       A1                12/2004      
       WO       WO20/05000159       A2                1/2005      
       WO       WO20/05020830       A1                3/2005      
       WO       WO20/05020833       A2                3/2005      
       WO       WO20/05023085       A2                3/2005      
       WO       WO20/05032326       A2                4/2005      
       WO       WO20/05032340       A2                4/2005      
       WO       WO20/05041799       A1                5/2005      
       WO       WO20/05044122       A1                5/2005      
       WO       WO20/05039651       A2                6/2005      
       WO       WO20/05051971       A1                6/2005      
       WO       WO20/05055874       A2                6/2005      
       WO       WO20/05020833       A3                7/2005      
       WO       WO20/05070314       A1                8/2005      
       WO       WO20/05092223       A2                10/2005      
       WO       WO20/05094693       A1                10/2005      
       WO       WO20/05094705       A2                10/2005      
       WO       WO20/05094706       A1                10/2005      
       WO       WO20/05096975       A2                10/2005      
       WO       WO20/05102196       A1                11/2005      
       WO       WO20/05107415       A2                11/2005      
       WO       WO20/05112804       A1                12/2005      
       WO       WO20/05112804       A1                12/2005      
       WO       WO20/05122931       A1                12/2005      
       WO       WO20/05122932       A2                12/2005      
       WO       WO20/05123171       A2                12/2005      
       WO       WO20/06011152       A2                2/2006      
       WO       WO20/06020530       A2                2/2006      
       WO       WO20/05112804       A9                3/2006      
       WO       WO20/06023793       A2                3/2006      
       WO       WO20/06026323       A2                3/2006      
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       WO       WO20/06026323       A9                4/2006      
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       WO       WO20/06042334       A2                4/2006      
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       WO       WO20/06055448       A1                5/2006      
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       WO       WO20/10065855       A1                6/2006      
       WO       WO20/06089929       A1                8/2006      
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       WO       WO20/06034436       A3                10/2006      
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       WO       2608693       A1                11/2006      
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       WO       WO20/10/017990                         2/2010      
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       WO       WO20/10037038       A2                4/2010      
       WO       WO20/10056895       A1                5/2010      
       WO       WO20/10062379       A1                6/2010      
       WO       WO20/10091242       A1                8/2010      
       WO       WO20/10035156       A1                11/2010      

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     * cited by examiner
 
     Primary Examiner —Nicholas Woodall
     Art Unit — 3775
     Exemplary claim number — 1
 
(74)Attorney, Agent, or Firm — Weiss & Arons LLP

(57)

Abstract

Apparatus and methods for preparing the interior of a bone for therapy. The therapy may include therapy for a bone fracture. The apparatus and methods may involve orienting a surgical instrument for proper deployment in the interior of the bone. An instrument guide may be positioned and retained against translation along, and rotation about one or more of three substantially orthogonal axes. Apparatus placed exterior to the bone may register the guide to a region inside the bone that is designated for preparation or treatment. One or more broaching members may be used to prepare the region for treatment. A broaching member may be expandable inside the bone. A broaching member may be flexible such that it broaches bone having a relatively lower density and it leaves bone having a relatively higher density substantially intact.
13 Claims, 43 Drawing Sheets, and 43 Figures


CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. patent application Ser. No. 14/594,482, filed on Jan. 12, 2015, which is a continuation of U.S. patent application Ser. No. 13/009,657, filed on Jan. 19, 2011, now U.S. Pat. No. 8,961,518, which is a nonprovisional of U.S. Provisional Applications Nos. 61/296,722, filed on Jan. 20, 2010, and 61/389,507, filed on Oct. 4, 2010, all of which are hereby incorporated by reference herein in their entireties.

FIELD OF TECHNOLOGY

[0002] Aspects of the disclosure relate to providing apparatus and methods for repairing bone fractures. In particular, the disclosure relates to apparatus and methods for repairing bone fractures utilizing a device that is inserted into a bone.

BACKGROUND

[0003] Bone fracture fixation may involve using a structure to counteract or partially counteract forces on a fractured bone or associated bone fragments. In general, fracture fixation may provide longitudinal (along the long axis of the bone), transverse (across the long axis of the bone), and rotational (about the long axis of the bone) stability. Fracture fixation may also preserve normal biologic and healing function.
[0004] Bone fracture fixation often involves addressing loading conditions, fracture patterns, alignment, compression force, and other factors, which may differ for different types of fractures. For example, midshaft fractures may have ample bone material on either side of the fracture in which anchors may be driven. End-bone fractures, especially on the articular surface may have thin cortical bone, soft cancellous bone, and relatively fewer possible anchoring locations. Typical bone fracture fixation approaches may involve one or both of: (1) a device that is within the skin (internal fixation); and (2) a device that extends out of the skin (external fixation).
[0005] Internal fixation approaches typically involve one or both of: (a) a plate that is screwed to the outside of the bone; and (b) an implant that is inserted inside the bone.
[0006] Plates are often characterized by relatively invasive surgery, support of fractured bone segments from one side outside of bone, and screws that anchor into the plate and the bone.
[0007] Implants may include intramedullary rods or nails, such as those used in mid shaft treatments. The typical intramedullary rod or nail is fixed in diameter and is introduced into the medullary canal through an incision. Flexible intramedullary rod-like solutions utilize structures that can be inserted into the medullary cavity through an access site and then be made rigid. The flexible structures may be reinforced with polymers or cements. Multi-segment fractures, of either the midshaft or end-bone, may require alignment and stability in a manner that generates adequate fixation in multiple directions. Implants may be used to treat midshaft fractures and end-bone fractures.
[0008] Implant-based therapies may involve removing bone tissue from the interior of the bone to prepare the interior for the implant. Preparation for the implant may involve providing a space in the bone interior for reception of the implant.
[0009] Proper location, size, shape, orientation and proximity to bone fragments and anatomical features, among other factors, may increase the therapeutic effectiveness of the implant.
[0010] It would be desirable, therefore, to provide apparatus and methods for preparation of a bone interior.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The objects and advantages of the invention will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:
[0012] FIG. 1 shows illustrative apparatus in accordance with principles of the invention.
[0013] FIG. 2 shows illustrative anatomy in connection with which the invention may be practiced.
[0014] FIG. 3 shows a view, taken along lines 3-3 (shown in FIG. 1) of a portion of the apparatus shown in FIG. 1.
[0015] FIG. 4 shows a view, taken along lines 4-4 (shown in FIG. 1) of a portion of the apparatus shown in FIG. 1.
[0016] FIG. 5 shows a view, taken along lines 5-5 (shown in FIG. 1) of a portion of the apparatus shown in FIG. 1.
[0017] FIG. 6 shows a portion of the apparatus shown in FIG. 1 along with other apparatus in accordance with principles of the invention.
[0018] FIG. 7 shows a portion of the apparatus shown in FIG. 1 in a state that is different from the state shown in FIG. 1.
[0019] FIG. 8 shows a portion of the apparatus shown in FIG. 1.
[0020] FIG. 9 shows a portion of the apparatus shown in FIG. 1 along with other apparatus in accordance with principles of the invention.
[0021] FIG. 10 shows a portion of the apparatus shown in FIG. 1.
[0022] FIG. 11 shows other illustrative apparatus in accordance with principles of the invention.
[0023] FIG. 12 shows a partial cross-sectional view, taken along lines 12-12 (shown in FIG. 11), of the apparatus shown in FIG. 11.
[0024] FIG. 13 shows a partial cross-sectional view, taken along lines 13-13 (shown in FIG. 11) of the apparatus shown in FIG. 11.
[0025] FIG. 14 shows other illustrative apparatus in accordance with principles of the invention.
[0026] FIG. 15 shows a portion of the apparatus shown in FIG. 14.
[0027] FIG. 16 shows a portion (labeled “16”) of the apparatus shown in FIG. 11.
[0028] FIG. 17 shows a view, taken along lines 17-17 (shown in FIG. 16) of a portion of the apparatus shown in FIG. 16.
[0029] FIG. 18 shows a view, taken along lines 18-18 (shown in FIG. 17) of the apparatus shown in FIG. 17.
[0030] FIG. 19 shows other illustrative apparatus in accordance with principles of the invention.
[0031] FIG. 20 shows a partial cross-sectional view, taken along lines 20-20 (shown in FIG. 7) of the apparatus shown in FIG. 7.
[0032] FIG. 21 shows a partial cross-sectional view, taken along lines 21-21 (shown in FIG. 8) of the apparatus shown in FIG. 8.
[0033] FIG. 22 shows a partial cross-sectional view, taken along lines 22-22 (shown in FIG. 21) of the apparatus shown in FIG. 21.
[0034] FIG. 22A shows the apparatus shown in FIG. 22 along with illustrative anatomy in connection with which the invention may be practiced.
[0035] FIG. 23 shows a view, taken along lines 23-23 (shown in FIG. 20), of the apparatus shown in FIG. 20.
[0036] FIG. 24 shows a partial cross-sectional view, taken along lines 24-24 (shown in FIG. 8) of the apparatus shown in FIG. 8.
[0037] FIG. 25 shows a portion of the apparatus shown in FIG. 9, along with other apparatus.
[0038] FIG. 26 shows a partial cross-sectional view, taken along lines 26-26 (shown in FIG. 25), of apparatus shown in FIG. 25.
[0039] FIG. 27 shows information that may be used to manufacture apparatus in accordance with the principles of the invention.
[0040] FIG. 28 shows a partial cross-sectional view, taken along lines 28-28 (shown in FIG. 25), of apparatus shown in FIG. 25.
[0041] FIG. 29 shows a partial cross-sectional view, taken along lines 29-29 (shown in FIG. 25), of apparatus shown in FIG. 25.
[0042] FIG. 30 shows apparatus shown in FIG. 25 in a state that is different from the state shown in FIG. 25.
[0043] FIG. 31 shows still other apparatus in accordance with the principles of the invention.
[0044] FIG. 32 shows yet other apparatus in accordance with the principles of the invention.
[0045] FIG. 33 shows yet other apparatus in accordance with the principles of the invention.
[0046] FIG. 34 shows yet other apparatus in accordance with the principles of the invention.
[0047] FIG. 35 shows yet other apparatus in accordance with the principles of the invention.
[0048] FIG. 36 shows yet other apparatus in accordance with the principles of the invention.
[0049] FIG. 37 shows a portion of the apparatus shown in FIG. 36.
[0050] FIG. 38 shows a partial cross-sectional view, taken along lines 38-38 (shown in FIG. 37), of the apparatus shown in FIG. 37.
[0051] FIG. 39 shows a partial cross-sectional view, taken along lines 39-39 (shown in FIG. 37), of the apparatus shown in FIG. 37.
[0052] FIG. 40 shows a partial cross-sectional view, taken along lines 40-40 (shown in FIG. 37), of the apparatus shown in FIG. 37.
[0053] FIG. 41 shows yet other apparatus in accordance with the principles of the invention.
[0054] FIG. 42 shows yet other apparatus in accordance with the principles of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0055] Apparatus and methods for preparing the interior of a bone for therapy are provided. The therapy may include therapy for a bone fracture. The apparatus and methods may involve orienting a surgical instrument for proper deployment in the interior of the bone. The surgical instrument may provide access from outside the bone to the interior of the bone. The surgical instrument may prepare the interior to receive a therapeutic device. The surgical instrument may include a therapeutic device.
[0056] Apparatus and methods for positioning a surgical instrument relative to exterior features of a bone are provided. The apparatus may be a surgical instrument guide.
[0057] The surgical instrument may be a device for repairing the bone. The surgical instrument may be a prosthetic device. For example, the surgical instrument may include one or more of the features of devices that are shown and described in U.S. Patent Application Publication No. 2009/0182336A1, which is hereby incorporated by reference herein in its entirety. The surgical instrument may be for accessing an interior region of the bone. For example, the surgical instrument may be a bone saw. The surgical instrument may be a drill. The surgical instrument may be for preparing the interior region of the bone to receive a therapeutic device. For example, the surgical instrument may be a broach.
[0058] The surgical instrument may have a portion that is configured to be positioned in a targeted region inside the bone.
[0059] The bone may have a surface. The surface may have a normal axis. The normal axis may be substantially perpendicular to the surface. The surface may have an anterior-posterior axis. The anterior-posterior axis may extend in a direction that is substantially normal to the anterior and posterior sides of the bone. The surface may have a proximal-distal axis. The proximal-distal axis may extend in a direction that is substantially along the bone. The bone surface may have curvature. The curvature may define a curvature axis. The curvature may be circumferential around the bone. The curvature axis may be parallel or near parallel with the proximal-distal axis.
[0060] The surgical instrument guide may include a bottom index. The bottom index may provide for aligning the device at a position along the surface normal axis. The position may be flush with the surface. The bottom index may be a bottom surface of the device. The bottom index may be one or more features that project from the bottom surface of the device.
[0061] The surgical instrument guide may include first and second lateral extensions. The first lateral extension may be configured to respond to an anterior contour of the bone. The anterior contour may be a contour on the anterior side of the bone. The second lateral extension may be configured to respond to a posterior contour of the bone. The posterior contour may be a contour on the posterior side of the bone. The first and second lateral extensions may provide for aligning the device along the anterior-posterior axis.
[0062] The surgical instrument guide may include a distal index. The distal index may be configured to provide visual alignment along the proximal-distal axis.
[0063] In some embodiments, the surgical instrument guide may include a first bone contactor. The first bone contactor may be configured to engage the surface. The apparatus may include a second bone contactor. The second bone contactor may be configured to engage the surface. When the first and second bone contactors engage the surface, the first and second contactors resist rotation about the surface normal axis.
[0064] In some embodiments, the first and second bone contactors may be configured to penetrate the surface.
[0065] In some embodiments, the surgical instrument guide may include first and second lateral cleats. The first lateral cleat may be configured to engage an anterior portion of the bone. The second lateral cleat may be configured to engage a posterior portion of the bone. When the first and second lateral cleats are engaged in the bone, the first and second lateral cleats may resist rotation about the proximal-distal axis of the bone.
[0066] The surgical instrument guide may include an instrument guide member. The surgical instrument guide may include an aligning member. The aligning member may be configured to align the guide member with the bone. The surgical instrument guide may include a base member. The base member may support the aligning member.
[0067] In some embodiments, the surgical instrument guide may include a lateral cleat. The lateral cleat may be configured to resist movement of the base member in a direction along the circumference of the elongated bone. The lateral cleat may include a stem that is directly fixed to the base.
[0068] In some embodiments, the surgical instrument guide may include a bone contactor. The bone contactor may be configured to resist rotation of the base about an axis that is substantially normal to the surface.
[0069] In some embodiments, the bone contactor may be a first bone contactor and the surgical instrument guide may include a second bone contactor. The first and second bone contactors may extend from a surface of the base. The first and second bone contactors may be configured to contact the bone surface along the curvature axis of the bone surface.
[0070] In some embodiments, the surgical instrument guide may include a handle support and a grip. The grip may be rotatable relative to the handle support when a torque greater than a threshold torque is applied to the grip.
[0071] In some embodiments, the surgical instrument guide may include an alignment template. The alignment template may be configured to register the instrument guide member to a target region inside the bone.
[0072] In some embodiments, the instrument template may include a dimension that corresponds to a dimension of a surgical instrument that is configured for deployment in the bone interior through the instrument guide member.
[0073] In some embodiments, the template may include a fluoroscopically detectable material.
[0074] In some embodiments, the template may be fixed to the base. The template may map to a lateral view plane in the cavity.
[0075] In some embodiments, the template may map to an anterior-posterior view plane in the cavity.
[0076] In some embodiments, the surgical instrument guide may include a first template that maps to the lateral view plane and a second template that maps to the anterior-posterior view plane.
[0077] In some embodiments, the surgical instrument guide may include a channel. The channel may be configured to direct an elongated fixation member into the bone. The elongated fixation member may be a wire. The wire may be a k-wire. The elongated fixation member may be a rod. The rod may be a threaded rod.
[0078] In some embodiments, the surgical instrument guide may include a first channel and a second channel. The first and second channels may be configured to direct first and second elongated fixation members into the bone.
[0079] In some embodiments, the first and second channels may be oblique to each other.
[0080] The methods may include a method for performing a procedure in a bone interior. The method may include positioning an instrument template outside the bone interior at a position that corresponds to a target region inside the bone. The method may include generating an electronic image showing the instrument template and the target region. The method may include delivering an instrument to the target region.
[0081] In some embodiments, the delivering may include arranging a guide member to direct the instrument to the target region. The guide member may have a fixed orientation relative to the instrument template.
[0082] In some embodiments, the positioning may include positioning a coring saw outline.
[0083] In some embodiments, the positioning may include positioning a broach outline.
[0084] In some embodiments, the positioning may include positioning a prosthesis outline.
[0085] In some embodiments, the positioning may include positioning a bone implant outline.
[0086] In some embodiments, the generating may include receiving an image using fluoroscopy.
[0087] In some embodiments, the instrument template may be a first instrument template and the method may include positioning a second instrument template outside the bone interior at a position that corresponds to the target region; and generating an electronic image showing the second instrument template and the target region.
[0088] In some embodiments, the positioning of a second instrument template may include arranging the second instrument template in a plane that is oblique to a plane that includes the first instrument template.
[0089] In some embodiments, the positioning of the second instrument template comprises arranging the second instrument template in a plane that is substantially orthogonal to a plane that includes the first instrument template.
[0090] In some embodiments, the delivering may include delivering a coring saw.
[0091] In some embodiments, the delivering may include delivering a bone interior broach.
[0092] In some embodiments, the delivering may include delivering a prosthesis.
[0093] The methods may include a method for guiding an instrument into a bone interior. The method may include positioning an instrument guide adjacent a bone. The instrument guide may include a first fixation element and a second fixation element.
[0094] The method may include passing a first fixation member through the bone such that the first fixation member is in contact with the first fixation element. The method may include passing a second fixation member through the bone such that the second fixation member is in contact with the second fixation element.
[0095] In some embodiments, the passing of a second fixation member may include orienting the second fixation member substantially obliquely with respect to the first fixation member.
[0096] In some embodiments, the passing of the second fixation member may include encompassing human tissue in a region defined by the first fixation member, the second fixation member and the instrument guide such that the instrument guide is retained adjacent the bone by the human tissue.
[0097] Apparatus and methods for guiding an instrument relative to an elongated bone are provided. The apparatus may be a surgical instrument guide.
[0098] The bone may have a longitudinal axis.
[0099] The surgical instrument guide may include an instrument guide member and a base member. The base member may support the guide member. The instrument guide member may be configured to pivot with respect to the base member from a first position to a second position. The first position may define a first angle relative to the bone longitudinal axis. The second position may define a second relative to the bone longitudinal axis.
[0100] In some embodiments, the surgical instrument guide may include an alignment template. The alignment template may register the instrument guide member to a first target region inside the bone when the guide member is in the first position. The alignment template may register the instrument guide member to a second target region inside the bone when the guide member is in the second position.
[0101] In some embodiments, the template may have a dimension that corresponds to a dimension of a surgical instrument that is configured for deployment in the bone interior through the instrument guide member.
[0102] In some embodiments, the template may include a fluoroscopically detectable material.
[0103] In some embodiments, the template may be fixed to the guide member. The template may map to a lateral plane in the bone interior. The template may map to an anterior plane in the cavity. The template may map to a posterior plane in the cavity.
[0104] In some embodiments, the template may be a first template and the surgical instrument guide may include a second template. The second template may be fixed to the guide member. The second template may map to a lateral plane in the cavity.
[0105] In some embodiments, the surgical instrument guide may include a guide member stop. The guide member stop may be configured to fix the position of the guide member with respect to the base member.
[0106] In some embodiments, the stop may induce a frictional force between a first surface on the guide member and a second surface on the base member.
[0107] In some embodiments, the stop may include a projection that interferes with relative movement between the guide member and the base.
[0108] The methods may include a method for introducing an instrument into an interior of a bone. The method may include introducing the instrument into a guide member that is pivotably mounted on a base. The base may be positioned adjacent a bone. The method may include pivoting the guide member relative to the base to change an angle between the guide member and the base. The method may include advancing the instrument through the guide member.
[0109] In some embodiments, the pivoting may include adjusting the angle to align an instrument template with a target region inside the interior of the bone.
[0110] In some embodiments, the adjusting may include viewing an electronic image that shows the instrument template and the target region.
[0111] In some embodiments, the method may include fixing the angle between the guide member and the base.
[0112] Apparatus and methods for broaching an interior region of a bone are provided. The bone may include first bone material. The first bone material may include cancellous bone. The bone may include second bone material. The second bone material may include cortical bone. The second bone material may have a density that is higher than a density of the first bone material.
[0113] The apparatus may include rotator. The apparatus may include a broaching member.
[0114] The broaching member may be moved in the bone interior to displace, disaggregate, disintegrate, dislocate, excavate, abrade, cut or otherwise broach bone material. The broaching member may be rotated in the bone interior. The rotation may be continuous. The rotation may be pulsed. The rotation may be unidirectional. The rotation may alternate between a first rotational direction and a second rotational direction.
[0115] The broaching member may be fixed to the rotator. The broaching member may be configured to be moved relative to the rotator to displace bone material that is radially away from the rotator.
[0116] In some embodiments, the broaching member may be configured to substantially deflect around second bone material.
[0117] In some embodiments, the broaching member may be configured to form in the bone a space having a first contour that corresponds to a shape of the broaching member. The broaching member may be configured to form in the bone a space having a second contour that corresponds to anatomy that includes the second bone material. The broaching member may be a first broaching member and the apparatus may include a second broaching member. The second broaching member may be disposed opposite the first broaching member.
[0118] In some embodiments, the broaching member may include a cutting edge.
[0119] In some embodiments, the broaching member may include a flexible wire segment. The wire segment may include braided wire.
[0120] In some embodiments, the apparatus may include a reinforcement that supports the broaching member. The reinforcement may support a cutting edge.
[0121] In some embodiments, the broaching member may have a proximal end that is fixed to the rotator and a distal end that is fixed to the rotator.
[0122] In some embodiments, the broaching member may have a proximal end that is fixed to the rotator and a distal end that is free.
[0123] In some embodiments, the broaching member may include an edge of an open cell in a mesh.
[0124] The broaching member may include a segment that has any suitable form. For example, the segment may be straight, circular, rhombic, square, triangular, oval, ellipsoid, spiral, loop-shaped, hoop-shaped, teardrop-shaped, egg-beater-shaped, football-shaped, or any other suitable shape. The segment may be a closed loop. The loop may be asymmetric.
[0125] The segment may have one or more of a variety of transverse cross sections, such as square, rectangular, octagonal, contours with sharp edges, stranded cable, or other suitable configurations to facilitate bone displacement.
[0126] The segment may have a leading edge. The leading edge may be beveled at a suitable angle, including an angle from about 50 to about 75°. The angle may cause leading edge 2202 to be generally sharp or knife-like.
[0127] The segment may be rigid. The segment may be resilient.
[0128] The broaching member may have one or more ends that are attached to apparatus such as a drive shaft or a suitable support, such as a hub. The broaching member may have a free end. Broaching members with free distal ends may have any suitable shape at the tine distal ends, such as pointed, forked, rounded, blunt or truncated.
[0129] The broaching member may have an end that is attached to apparatus by crimping, welding, set-screw, snap fit or any other suitable fastening. The broaching member may have one or more ends that are of unitary construction with the apparatus.
[0130] The broaching member may include a tine. The tine may be resilient or stiff. The tine may have an end that is attached to a drive shaft. The tine may have a free end.
[0131] The broaching member may include a blade.
[0132] The broaching member may include numerous interconnected cells. The cells may be arranged in a network. The cells may be linked such that when the structure is stressed (e.g., compressed) at a point the stress is distributed to nearby cells. The cells may be constructed from laser-cut tube stock that is expanded into a suitable shape.
[0133] The broaching member may be one of a number of broaching members in a broaching head. For example, the broaching head may have one broaching member, 2-6 broaching members, 7-20 broaching members, more than 20 broaching members, 100 broaching members or any suitable number of broaching members.
[0134] When a large number (i.e., when the circumferential density of broaching members is relatively high) of broaching members are present during the rotation of a broaching head, a relatively lower torque may be required to drive the broaching head.
[0135] Broaching member may rotate in a bone cavity that has an irregular shape, for example, nonround, oblong, or angular. The cavity may be smaller than a diameter of broaching member.
[0136] Broaching member may include any suitable structural form such as wire, ribbon, cable, stranded wire, braided wire, braided ribbon, or any other suitable structural form.
[0137] Broaching member may include any suitable material, such as polymer, metal, composite, stainless steel, Nitinol (shapeset, superelastic or other Nitinol), other alloy or any other suitable material.
[0138] The broaching member may be supported by one or more reinforcements.
[0139] The reinforcement may be sized and positioned to support a segment of the broaching member in a desired contour. The reinforcement may provide bone-broaching abrasiveness, momentum or both.
[0140] The reinforcement may be a tube.
[0141] The reinforcement may be a brace. The brace may be fixed to the broaching member, for example, by crimping, welding or press-fit. The brace may include broaching edges for displacing bone material. The broaching edges may have any suitable form, such as serrated, saw-tooth, knife-edge, rectilinear edge or any other suitable form.
[0142] The reinforcement may be formed from polymer, metal, alloy or any other suitable material.
[0143] The reinforcement may be formed from a pattern that is cut into a metal tube.
[0144] In some embodiments, the apparatus may include a distal hub. The broaching member may have a distal end that is fixed to the distal hub. The distal hub may be configured to move between a first position and a second position. The first and second positions may be located along a longitudinal axis of the rotator.
[0145] The distal hub may be constructed of metal, stainless steel, laser-cut tube, polymer, ceramic or any other suitable material.
[0146] The distal hub may include flutes. The distal hub may include broaching edges.
[0147] The methods may include a method for broaching an interior region of a bone. The interior region may include a bottom surface. The bottom surface may be an surface of a portion of the bone that is opposite an access hole in the bone.
[0148] The method may include expanding a bone broaching member in the interior region. The method may include disaggregating relatively low-density material inside the bone using the member. The method may include deflecting the broaching member away from relatively high-density material inside the bone.
[0149] In some embodiments, the method may include rotating the bone broaching member using a flexible drive shaft.
[0150] In some embodiments, the method may include changing the elevation of the bone broaching member relative to the bottom surface.
[0151] In some embodiments, the disaggregating may include cutting the relatively low-density material.
[0152] In some embodiments, the disaggregating may include displacing the relatively low-density material.
[0153] In some embodiments, the method may include registering an exterior instrument guide to the bone broaching member; visually mapping the exterior instrument guide to the interior region; and deploying the bone broaching member to the interior region based on the exterior instrument guide. The exterior instrument guide may be exterior to the bone.
[0154] Apparatus and methods for treating a bone interior are provided.
[0155] The apparatus may include a flexible sheath. The flexible sheath may include stress-relief features that allow bending under tension and compression. The stress-relief features may include slots or slot patterns. The stress-relief features may be provided using laser-cutting.
[0156] The stress-relief features may include sintered particles. The particles may include metal, polymer, composite or any other suitable material.
[0157] The flexible sheath may have a first configuration and a second configuration. The second configuration may have a smaller radius of curvature than the first configuration. The apparatus may include a rotatable shaft. The rotatable shaft may extend through the sheath. The apparatus may include an elongated steering member. The elongated steering member may be configured to deflect the flexible sheath from the first configuration to the second configuration.
[0158] In some embodiments, the elongated steering member may be configured to be elastically deformed when the elongated steering member deflects the flexible sheath from the first configuration to the second configuration.
[0159] In some embodiments, the elongated steering member may include a first portion. The first portion may translate along a longitudinal direction of the sheath. The elongated steering member may include a second portion. The second portion may be configured to extend radially outward through a passage in the sheath when the elongated steering member deflects the flexible sheath from the first configuration to the second configuration.
[0160] In some embodiments, the rotatable shaft may have a distal end and the apparatus may include an expandable head that extends from the distal end. The expandable head may include a compressed configuration for translating within the sheath. The expandable head may include an expanded configuration when the expandable head is deployed outside the sheath.
[0161] In some embodiments, the expandable head may be configured to displace cancellous bone and not cortical bone.
[0162] Apparatus and methods for preparation of the interior of a bone are provided.
[0163] The apparatus may include an elongated member. The elongated member may have a longitudinal axis. The elongated member may be curved about the longitudinal axis. The elongated member may be configured to rotate about the longitudinal axis inside the bone.
[0164] In some embodiments, the elongated member may include a substantially spiral segment. The spiral segment may include a proximal end and a distal end. The proximal end may be disposed at a first radius from the longitudinal axis. The distal end may be disposed at a second radius from the longitudinal axis. The second radius may be at least as great as the first radius. The second radius may be greater than the first radius.
[0165] In some embodiments, the elongated member may be a first elongated member and the apparatus may include a second elongated member. The second elongated member may be curved about the longitudinal axis. The second elongated member may be configured to rotate about the longitudinal axis.
[0166] In some embodiments, the second elongated member may include a substantially spiral second segment.
[0167] In some embodiments, the proximal end may be a first proximal end and the distal end may be a first distal end. The spiral second segment may include a second proximal end and a second distal end. The second proximal end may be disposed at a third radius from the longitudinal axis. The second distal end may be disposed at a fourth radius from the longitudinal axis. The fourth radius may be at least as great as the third radius. The fourth radius may be greater than the third radius.
[0168] In some embodiments, the third radius may be substantially the same as the first radius; and the fourth radius may be substantially the same as the second radius.
[0169] In some embodiments, the apparatus may include a circumferential offset. The circumferential offset may be in a circumferential direction about the longitudinal axis. The circumferential offset may be between the second proximal end and the first proximal end. The circumferential offset may be between the second distal end and the first distal end.
[0170] In some embodiments, the apparatus may include a support. The support may include a proximal support end. The proximal support end may be fixed to a shaft. The apparatus may include a support segment. The support segment may be fixed to at least one of the first and second spiral segments. The support segment may conform to a contour of the spiral segment.
[0171] The methods may include a method for preparing a bone interior. The method may include providing access to a bone intramedullary space. The method may include introducing into the intramedullary space an elongated member. The elongated member may have a substantially spiral segment. The spiral segment may have a longitudinal axis. The method may include rotating the substantially spiral segment about the longitudinal axis to displace cancellous bone matter.
[0172] In some embodiments, the elongated member may be a first elongated member, the substantially spiral segment may be a first substantially spiral segment, and the method may include introducing into the intramedullary space a second elongated member. The second elongated member may have a substantially spiral second segment. The substantially spiral second segment may share the longitudinal axis with the first substantially spiral segment. The method may include rotating the substantially spiral second segment about the longitudinal axis.
[0173] In some embodiments, the first spiral segment may have a first periodic rotation cycle. The second spiral segment may have a second periodic rotation cycle. The second periodic rotation cycle may lag behind the first periodic rotation cycle by a phase lag. The phase lag may be about Pi radians.
[0174] Apparatus and methods for sawing a hole in a bone are provided. The bone may have a longitudinal bone axis.
[0175] The apparatus may include a bone coring saw. The bone coring saw may include a tooth. The tooth may include a first cutting member and a second cutting member. The first cutting member may be configured to cut bone when the coring saw rotates in a first direction. The second cutting member may be configured to cut bone when the coring saw rotates in a second direction. The second direction may be rotationally opposite from the first direction.
[0176] The bone coring saw may include a cylindrical tube. The cylindrical tube may define a tube longitudinal direction and a tube radial direction. The bone coring saw may include a saw tooth. The saw tooth may extend longitudinally from an end of the cylindrical tube. The saw tooth may include a cutting surface that is oblique to the tube radial direction.
[0177] The methods may include a method for sawing a hole in the bone. The method may include forming a substantially cylindrical passage into the intramedullary space of a bone. The substantially cylindrical passage may extend along a direction that is at an acute angle to the longitudinal bone axis. The method may include removing from the bone a substantially cylindrical plug that is substantially coaxial with the passage.
[0178] In some embodiments, the forming may include tunneling through the bone using a K-wire.
[0179] In some embodiments, the removing may include sawing a hole using a rotary coring saw.
[0180] In some embodiments, the method may include rotating the rotary coring saw about a portion of the K-wire.
[0181] In some embodiments, the method may include sustaining a coaxial relationship between the K-wire and the rotary coring saw. The sustaining may include rotating the rotary coring saw about a bushing. The K-wire, the bushing and the rotary coring saw may be substantially coaxial.
[0182] In some embodiments, the method may include translating the K-wire relative to the rotary coring saw to remove from the coring saw the cylindrical plug.
[0183] The method may include a method for providing access to an intramedullary space of a bone. The method may include supporting a cylindrical body of a rotary saw at an acute angle to a surface of the bone; and engaging teeth of the rotary saw with the surface.
[0184] Apparatus and methods for accessing the inside of a bone are provided.
[0185] The apparatus may include a rotatable saw that includes a cannula. The apparatus may include a bushing that is disposed in the cannula. The apparatus may include a wire that is disposed substantially coaxially with the rotatable saw in the bushing.
[0186] In some embodiments, the wire may include a distal end that is configured to penetrate the bone. The wire may include a proximal end that is configured to receive torque.
[0187] In some embodiments, the wire may be configured to drill a pilot hole in the bone. The pilot hole may have an axis that forms an acute angle with a surface of the bone at the opening of the pilot hole. The saw may include teeth. The teeth may be arranged adjacent a distal end of the cannula. The bushing may be configured to align the rotatable saw coaxially with the axis when the teeth contact the bone.
[0188] In some embodiments, the apparatus may include a biased member proximal the bushing. The biased member may be configured to urge a distal end of the bushing toward the bone when the teeth have penetrated into the bone.
[0189] In some embodiments, the bushing may be fitted into the cannula with a tolerance that provides friction between the bushing and the rotatable saw. The friction may resist proximally-directed force from a bone core in the cannula while the teeth are cutting into the bone.
[0190] In some embodiments, the rotatable saw may include a cylindrical body having a wall thickness that is traversed by a vent. The vent may be configured to exhaust bone matter.
[0191] In some embodiments, the wire may include a distal diameter and a proximal diameter. The proximal diameter may be greater than the distal diameter. The wire may include a shoulder where the distal diameter adjoins the proximal diameter. The shoulder may be configured to be translated proximally relative to the rotatable saw to eject a bone core from the cannula.
[0192] The apparatus may include an assembly for accessing the inside of a bone.
[0193] The assembly may include an arrangement of teeth. The teeth may be supported at the end of a rotatable frame. The frame may define one or more passageways. The passageways may extend from a cannula inside the frame to a region that is outside the frame.
[0194] In some embodiments, the assembly may include a bushing. The bushing may be disposed in the cannula. The assembly may include a wire. The wire may be disposed substantially coaxially with the rotatable saw in the bushing.
[0195] In some embodiments, the wire may be configured to drill a pilot hole in the bone. The pilot hole may have an axis that forms an acute angle with a surface of the bone at the opening of the pilot hole. The busing may be configured to align the rotatable saw coaxially with the axis when the teeth contact the bone.
[0196] Apparatus and methods for preparing a bone interior are provided. The apparatus may have a longitudinal apparatus axis.
[0197] The apparatus may include one or more broaching members. The broaching members may be blades. A first blade may be linked to a second blade by a linkage. The linkage may be configured to be rotated about the longitudinal axis. The linkage maybe configured to be radially displaced from the longitudinal apparatus axis.
[0198] In some embodiments, at least one of the first and second blades may be rigid.
[0199] In some embodiments, at least one of the first and second blades may include stainless steel.
[0200] In some embodiments, at least one of the first and second blades may include Nitinol.
[0201] In some embodiments, the linkage may include a pin.
[0202] In some embodiments, the linkage may be a first linkage. The apparatus may include an actuator. The actuator may be linked to the first blade by a second linkage. The actuator may be linked to the second blade by a third linkage. The actuator may include a main body. The main body may include members that are configured to be displaced relative to each other. One of the members may be fixed relative to the main body.
[0203] In some embodiments, at least one of the second and third linkages may include a pin.
[0204] In some embodiments, the third linkage is distal the second linkage.
[0205] In some embodiments, the actuator may be configured to radially displace the first linkage by changing a distance between the second linkage and the third linkage.
[0206] In some embodiments, the actuator may include a first elongated actuator member. The first elongated actuator member may be linked to the second linkage. The actuator may include a second elongated actuator member. The second elongated actuator member may be linked to the third linkage. The second elongated actuator member may be configured to radially displace the first linkage by changing a longitudinal offset between the first and second elongated members.
[0207] In some embodiments, the apparatus may be configured to traverse a path in the bone interior. The apparatus may include a fourth linkage that constrains the longitudinal offset based on position of the apparatus along the path.
[0208] In some embodiments, the fourth linkage may be a manual linkage.
[0209] In some embodiments, the longitudinal offset may include a range of values. The range of values may include a first value. The first value may correspond to a first linkage first radial displacement. The range of values may include a second value. The second value may correspond to a first linkage second radial displacement. The second radial displacement may be greater than the first radial displacement.
[0210] In some embodiments, the range may include a third value. The third value may correspond to a first linkage third radial displacement. The first linkage third radial displacement may be less than the second radial displacement.
[0211] In some embodiments, the apparatus may include a cutting surface. The cutting surface may be disposed on one of the first and second blades. At the first and third radial displacements, the cutting surface may be disengaged from the bone.
[0212] In some embodiments, at the second radial displacement, the cutting surface may be engaged with the bone.
[0213] In some embodiments, the first blade may have a first bound portion. The first bound portion may be between the first and second linkages. The first blade may have a first free portion. The first free portion may extend beyond the first linkage in a direction away from the second linkage.
[0214] In some embodiments, the second blade may have a second bound portion. The second bound portion may be between the first and third linkages. The second blade may have a second free portion. The second free portion may extend beyond the first linkage in a direction away from the third linkage.
[0215] In some embodiments, the first bound portion may be longer than the second bound portion.
[0216] In some embodiments, the second bound portion may be longer than the first bound portion.
[0217] In some embodiments, the first free portion may be longer than the second free portion.
[0218] In some embodiments, the second free portion may be longer than the first free portion.
[0219] In some embodiments, the apparatus may include a cutting surface. The cutting surface may be disposed on at least one of the first and second blades. The fourth linkage may be programmed to position the cutting surfaces at different radial displacements along the path. Each of the radial displacements may correspond to a longitudinal position on the path.
[0220] In some embodiments, the fourth linkage may control the longitudinal offset based on an electronic signal. The electronic signal may be based on a set of digital instructions. The digital instructions may be based on a digitized image of the bone interior.
[0221] In some embodiments, the apparatus may include a third blade. The apparatus may include a fourth blade. The third blade may be linked to the fourth blade by a fourth linkage. The fourth linkage may be configured to be rotated about the longitudinal axis. The fourth linkage may be configured to be radially displaced from the longitudinal axis. The actuator may be configured to radially displace the fourth linkage by changing the longitudinal offset between the first and second elongate members.
[0222] The methods may include a method for preparing the bone interior. The method may include rotating a cutting surface inside a bone about a rotational axis. The method may include moving a control member from a first control position to a second control position.
[0223] The cutting surface may be configured to occupy a first radial position that corresponds to the first control position. The cutting surface may be configured to occupy a second radial position that corresponds to the second control position. The cutting surface may be configured to occupy a third radial position that corresponds to an intermediate control position. The intermediate control position may be between the first and second control positions. The third radial position may be at a greater radial distance from the rotational axis than are both the first and second radial positions.
[0224] In some embodiments, the first and second radial positions may be at substantially the same distance from the rotational axis.
[0225] In some embodiments, when the cutting surface is at one or both of the first and second radial positions, the cutting surface may be disengaged from the bone. When the cutting surface is at the third radial position, the cutting surface may be engaged with the bone.
[0226] Apparatus and methods for positioning a bone fragment are provided.
[0227] The apparatus may include a probe support. The probe support may have a proximal end and a distal end. The apparatus may include a handle. The handle may be attached to the proximal end. The apparatus may include a probe. The probe may be attached to the distal end. The probe support may be configured to traverse an angled access hole in a metaphyseal bone surface. The probe support may be configured to provide mechanical communication between the handle and the probe when the handle is outside a bone interior and the probe is inside the bone interior.
[0228] In some embodiments, the probe may have a conical tip.
[0229] In some embodiments, the probe may have a rounded tip.
[0230] In some embodiments, the probe support may include a proximal segment and a distal segment. The proximal segment may extend from the handle. The distal segment may support the probe.
[0231] In some embodiments, the proximal and distal segments may define an obtuse angle.
[0232] In some embodiments, the proximal segment may have a first flexibility. The distal segment may have a second flexibility. The second flexibility may be greater than the first flexibility.
[0233] In some embodiments, the apparatus may include an intermediate segment. The intermediate segment may be between the proximal and distal segments. The intermediate segment may include a curve.
[0234] In some embodiments, the proximal segment may have a first flexibility. The intermediate segment may have a second flexibility. The distal segment may have a third flexibility. The second flexibility may be greater than the third flexibility.
[0235] The methods may include a method for treating a bone. The bone may have a longitudinal bone axis.
[0236] The method may include providing a hole in the bone. The hole may be at an angle to the longitudinal bone axis. The hole may provide access to a bone interior region. The method may include advancing a probe through the hole and into the interior region. The method may include displacing cancellous bone using the probe.
[0237] In some embodiments, the displacing may include identifying a spatial distribution of low-density matter in the interior region.
[0238] In some embodiments, the method may include displaying an image of the interior region and the probe when the probe is inside the interior region.
[0239] The methods may include another method for treating the bone. The method may include providing a hole in the bone. The hole may be at an angle to the longitudinal bone axis. The hole may provide access to a bone interior region. The method may include advancing a probe through the hole and into the interior region. The method may include displacing bone matter using the probe.
[0240] In some embodiments, the displacing may include identifying a spatial distribution of cancellous bone in the interior region.
[0241] In some embodiments, the method may include displaying an image of the interior region and the probe when the probe is inside the interior region.
[0242] In some embodiments, the displacing may include positioning a first cortical bone fragment relative to a second cortical bone fragment.
[0243] In some embodiments, the method may include displaying an image of the interior region and the probe when the probe is inside the interior region.
[0244] Apparatus and methods in accordance with the invention will be described in connection with the FIGS. The FIGS. show illustrative features of apparatus and methods in accordance with the principles of the invention. The features are illustrated in the context of selected embodiments. It will be understood that features shown in connection with one of the embodiments may be practiced in accordance with the principles of the invention along with features shown in connection with another of the embodiments.
[0245] Apparatus and methods described herein are illustrative. Apparatus and methods of the invention may involve some or all of the features of the illustrative apparatus and/or some or all of the steps of the illustrative methods. The steps of the methods may be performed in an order other than the order shown or described herein. Some embodiments may omit steps shown or described in connection with the illustrative methods. Some embodiments may include steps that are not shown or described in connection with the illustrative methods.
[0246] Illustrative embodiments will now be described with reference to the accompanying drawings, which form a part hereof.
[0247] The apparatus and methods of the invention will be described in connection with embodiments and features of an illustrative bone repair device and associated hardware and instrumentation. The device and associated hardware and instruments will be described now with reference to the FIGS. It is to be understood that other embodiments may be utilized and structural, functional and procedural modifications may be made without departing from the scope and spirit of the present invention.
[0248] FIG. 1 shows illustrative instrument guide 100 positioned at site H′ on bone B. Broach head 124 may be delivered through guide 100 to target region Rt of intramedullary space IS. Target region Rt is illustrated as being within cancellous bone BCA, but could be in either, or both, of cancellous bone BCA and cortical bone BCO. Side template 130 and top template 132 are registered to guide tube 120. Arm 131 may support template 130. A practitioner may position templates 130 and 132 such that templates 130 and 132 “project” onto target region Rt so that guide 100 will guide broach head 124 to target region Rt.
[0249] Template 130 may include lobe outline 134 and shaft outline 136 for projecting, respectively, a “swept-out” area of broach head 124 and a location of shaft-like structure 125. Template 132 may include lobe outline 138 and shaft outline 140 for projecting, respectively, a target “swept-out” area of broach head 124 and a target location of shaft-like structure 125. Templates 130 and 132 may be configured to project a shape of any suitable instrument that may be deployed, such as a drill, a coring saw, a prosthetic device or any other suitable instrument.
[0250] Fluoroscopic imaging may be used to position templates 130 and 132 relative to target region Rt.
[0251] Broach head 124 may rotate in intramedullary space IS to clear intramedullary bone matter so that a prosthetic device may be implanted. Broach head 124 may be driven and supported by broach control 126 and broach sheath 127.
[0252] Guide 100 may include base 102. Alignment members 104 and 106 (shown in FIG. 10) may extend from base 102 to align guide centerline CLG of guide 100 with bone centerline CLBS of the top surface of bone B. One or both of alignment members 104 and 106 may be resilient. One or both of alignment members 104 and 106 may be stiff.
[0253] Alignment members 104 and 106 may be relatively free to slide along surfaces of bone B. Guide 100 may include contacts 108 and 110 (shown in FIG. 10) that may engage bone B along centerline CLBS. Contacts 108 and 110 may extend from a bottom surface (shown in FIG. 10) of guide 100. Contacts 108 and 110 may prevent guide centerline CLG from rotating out of alignment with bone centerline CLBS.
[0254] Contacts 108 and 110 may assure alignment of guide 100 with the surface of bone B, because two points of contact may be stable on an uneven surface even in circumstances in which 3, 4 or more contacts are not stable.
[0255] Guide 100 may include lateral cleats 112 and 114 (shown in FIG. 10). Lateral cleats 112 and 114 may engage the surface of bone B to prevent guide 100 from rotating in direction θ about guide centerline CLG. Lateral cleats 112 and 114 may be resilient to allow some sliding over bone B.
[0256] When a practitioner positions guide 100 on bone B, alignment members 104 and 106 may be the first components of guide 100 to engage bone B. Alignment members 104 and 106 may bring guide centerline CLG into alignment with bone centerline CLBS before contacts 108 and 110 and cleats 112 and 114 engage bone B. Then, in some embodiments, cleats 112 and 114 may engage bone B to inhibit rotation in direction θ. Then, in some embodiments, contacts 108 and 110 may engage bone B along bone centerline CLBS. Contacts 108 and 110 may have sharp points to provide further resistance to de-alignment of guide centerline CLG from bone centerline CLBS. In some embodiments, there may be no more than two contacts (e.g., 108 and 110) to ensure that the contacts are in line with bone centerline CLBS.
[0257] Guide 100 may include stem 116 and grip 118. A practitioner may manually grip grip 118. In some embodiments, a torque-limiter (not shown) may be provided to limit the torque that the practitioner can apply via grip 118 to contacts 108 and 110.
[0258] Guide tube 120 may receive and guide any suitable instrument. Guide tube 120 may be oriented at angle α with respect to handle 116. In some embodiments, angle α may be fixed. In some embodiments, angle α may be adjustable. In some embodiments, templates 130 and 132 may be fixed relative to guide tube 120. In some embodiments, including some embodiments in which a is adjustable and some in which a is not adjustable, guide tube 120 may be oriented so that the axis LGT of guide tube 120 intersects bone B at substantially the same point as does axis LH of stem 116. Grip 118 will thus be positioned directly over the center of hole site H′.
[0259] Guide 100 may include channels 142 and 144 (shown in FIG. 5). Rods 146 and 148 may be inserted through channels 142 and 144, respectively, through cortical bone BCO. Rods 146 and 148 may stabilize guide 100 on bone B. Rods 146 and 148 may be K-wires. Rods 146 and 148 may be inserted using a wire drill.
[0260] FIG. 2 illustrates anatomical features of fractured bone B. Reference frame 200 shows that the view of bone B is substantially in anterior/posterior plane 200. Lateral plane 204 includes volar half-plane VOL and dorsal half-plane DOR.
[0261] Bone B is illustrated as a radius that is fractured at fractures Fh and Fa Bone B includes bone portions Pb, Ph and Pa in distal end D. Bone segment Pb is the largest portion of bone B. Bone segment Ph is a head portion of bone B. Bone segments Ph and Pa include articular surface AS.
[0262] Bone portions Pb, Ph and Pa are separated or partially separated along fractures Fa and Fh. Fracture Fa transects articular surface AS. Fracture Fh transects head of bone B.
[0263] Bone B, shown in a cross section that includes approximate longitudinal axis LB, includes cortical bone BCO and cancellous bone BCA. Deployment of an implant into distal end D of bone B may require an access hole at site H′. Deployment of the implant may require displacement of cancellous bone BCA. Illustrative contours C1, C2 and C3 in cancellous bone BCA are different contours within which cancellous bone BCA may be displaced. Contour C4, which is a projection of contour C3 onto articular surface AS, shows that contour C4, for example, may be asymmetric. For example, contour C4 may have major axis A1 and minor axis A2 (shown in half). The other contours may also be asymmetric.
[0264] Apparatus and methods provided herein may provide an access hole H at site H′. An apparatus inserted at site H′ through access hole H, may travel a distance xH through intermedullary space IS to reach a head portion of bone B. An apparatus inserted at site I′ through access hole I may travel a distance xI through intermedullary space IS to reach a head portion of bone B. An apparatus inserted at H′ may require a “bend” to travel through intermedullary space IS to reach a head portion of bone B. An apparatus inserted at I′ may not require a “bend” to reach a head portion of bone B. Apparatus and methods provided herein may displace cancellous bone BCA within a contour such as C1, C2 or C3.
[0265] FIG. 3 shows guide 100, from the side, positioned at site H′ at which an access hole is to be provided. Template 130 is positioned to register with target area Rt a broach (with outline 134) and a drill (with outline 136). Template 132 extends normal to the plane of FIG. 3. Fluoroscopy may be used to select the target area based on contours of cancellous bone BCA and cortical bone BCO (shown in FIG. 2) in bone B. A rod such as a K-wire may be inserted through hole 302 and bone B to fix a position of guide 100 relative to bone B.
[0266] FIG. 4 shows guide 100, from the top, positioned at site H′ (not shown). Template 132 is positioned to register with target area Rt the broach (with outline 138) and the drill (with outline 140).
[0267] Template 132 extends from the base of grip 118.
[0268] Arm 404 supports template 130, which extends normal to the plane of FIG. 3. Fluoroscopy may be used to select the target area based on contours of cancellous bone BCA (shown in FIG. 2) and cortical bone BCO (shown in FIG. 2) in bone B. A rod such as a K-wire may be inserted through hole 402 and bone B to fix a position of guide 100 relative to bone B.
[0269] Cannula 406 is present in guide tube 120 for delivering instruments to intramedullary space IS (shown in FIG. 2) of bone B.
[0270] FIG. 5 shows guide 100, from above and posterior, positioned at site H′. H′ is approximately centered along axis LGT of guide tube 120. Distal ends of rods 146 and 148 penetrate bone B to maintain a position of guide 100. Rods 146 and 148 may be at oblique to each other. Rods 146 and 148 may be skewed relative to each other.
[0271] FIG. 6 shows illustrative drill 600 inserted in guide tube 120 and penetrating bone B. Drill 600 may penetrate cortical bone BCO (shown in FIG. 2) and cancellous bone BCA (shown in FIG. 2). Drill 600 may include teeth 602, flutes 604, shaft 606, torque adapter 608 and any other suitable features. Torque adapter 608 may be an A-O type torque adapter or any other suitable torque adapter. Stop 610 may be present to limit penetration depth dP of drill 600. Stop 610 may be any suitable feature that limits forward axial motion of members 600. Stop 610 may include annular distal surface 612, which may abut rim 614 of guide tube 120 when dP is reached. Fastener 616, which may be a set screw, may be used to fix the position of stop 610 along shaft 606 to fix the magnitude of dP.
[0272] FIG. 7 shows illustrative intramedullary broach 700. Broach 700 may include broach head 702. Broach head 702 may include illustrative broaching member 704.
[0273] Broaching member 704 may be sufficiently rigid to displace cancellous bone BCA. Broaching member 704 may be sufficiently flexible to be deformed by cortical bone BCO. In some embodiments, broaching member 704 may be expandable. Broach head 702 may be supported by and rotated by shaft assembly 714. Broach control 706 may include drive handle 708 for rotating and translating broach head 702. Broach control 706 may include expansion control hub 710. Expansion control hub 710 may be displaceable along control shaft to expand or contract broaching member 704. Broach head 702 may include distal end 780. Expansion control hub 710 is shown in the “contract” position.
[0274] FIG. 8 shows broach 700 deployed in bone B through hole H. Broach 700 may be deployed while broaching member 704 is contracted.
[0275] Broach head 702 may be advanced, through intramedullary space IS, into metaphyseal region M of bone B. Broach head 702 may be disposed in any portion of intramedullary space IS, such as in the end-bone.
[0276] Access hole H may be sufficiently small that it reduces the occurrence of cause stress risers at site H′. Expansion control hub 710 is shown in the “expand” position and broaching member 704 is shown expanded in bone B. Broaching member 704 may be expanded during or after deployment.
[0277] A standard orthopaedic drill instrument (not shown) may be used to open access hole H in cortical bone BCO (shown in FIG. 2) at site H′ on bone B. The drill instrument may be guided by apparatus such as guide 100 (shown in FIG. 1). Axis hole H may be drilled along broach axis LC. Broach axis LC may form an angle β with bone axis LB. Broach 700 may be positioned such that broach axis Lc substantially coincides with guide tube axis LGT (shown in FIG. 1). Angle β may be an acute angle. Angle β may be complementary with angle α (shown in FIG. 1).
[0278] FIG. 9 shows illustrative instrument guide 900 at site H′ on bone B. Instrument guide 900 may have one or more features in common with instrument guide 100 (shown in FIG. 1). Instrument guide 900 may include instrument templates 930 and 932 for positioning instrument guide 900 such that an instrument can be positioned at target region St1.
[0279] Illustrative steerable broach 950 may be deployed at target region St1 in intramedullary space IS by insertion through guide 900 at site H′. Broach 950 may include broach head 925. Broach head 925 may have one or more features or properties in common with broach head 125 (shown in FIG. 1). Broach head 925 may be supported by broach sheath 927. Broach head 925 may be rotated by drive shaft 940 which may extend inside broach sheath 927 and receive torque from torque adapter 908. Torque adapter 908 may provide rotation from any suitable rotation source drive shaft 940.
[0280] Broach sheath 927 may be flexible. Broach sheath 927 may be flexible in region 928 such that application of off-axis tension by elevator ribbon 952 may position broach head 925 at a distance y or −y relative to bone axis LB. Illustrative elevator control body 960 may apply axial compression to elevator ribbon 952 to cause broach sheath 927 to bend.
[0281] Broach sheath 927 may be configured to flex in more than one plane. Broach sheath 927 may be configured to flex substantially in one plane only.
[0282] Target region St1 could be in either, or both, of cancellous bone BCA and cortical bone BCO (shown in FIG. 2). Side template 930 and top template 932 are registered to guide tube 920. A practitioner may position templates 930 and 932 such that templates 930 and 932 “project” onto target region St1 so that guide 900 will guide broach head 925 to target region St1.
[0283] Side template 930 may be rotatable at arm 942 to change angle γ between side template 930 axis LT and guide 900 centerline CLGT. γ may be selected to correspond to a degree of elevation in direction y or −y of broach head 925. γ may be selected to correspond to a degree of actuation of control 962 of control body 960. For example, γ may be selected such that side template 930 “projects” onto target region St2.
[0284] Fluoroscopic imaging may be used to position templates 930 and 932 relative to target region St1.
[0285] A practitioner can select the position of H′ (distance xH shown in FIG. 2), the angle of hole H (shown in FIG. 2) relative to bone axis LB, the degree and distribution of flexing in region 928, the penetration of broach sheath 927, the size of broach head 925, the swept-out profile of broaching member 924, and any other suitable parameters, to determine the size, shape, orientation and location of a cavity to be swept out by broaching member 924. For example, one or more of the aforementioned parameters may be selected to position broach head 925 in target region St2.
[0286] FIG. 10 shows guide base 102 from below on the distal side. Stem 116 extends from the top of base 102. Guide tube 120 extends from the distal portion of base 102. Arm 131 extends from the side of base 102. Site H′ of hole H (shown in FIG. 2) is shown projected onto opening 1002 of guide tube 120 and centered about axes LH and LGT.
[0287] Illustrative contacts 108 and 110 extend down from base 102 to engage bone B (shown in FIG. 2) and resist rotation about vertical axes LH and LTR and translation along guide centerline CLG. Contacts 108 and 110 may be sufficiently sharp to penetrate or partially penetrate bone B. Cleats 112 and 114 may engage the surface of bone B and resist rotation about guide centerline CLG. Base 102 may support any suitable number of contacts in any suitable pattern or location. Base 102 may support an arrangement of contacts that extends in a direction that is substantially oblique or transverse to guide centerline CLG.
[0288] In some embodiments, base 102 may include a flange (not shown) that saddles bone B. The flange may include any suitable number of contacts in any suitable pattern, including an arrangement of contacts that extends in a direction that is substantially oblique or transverse to guide centerline CLG.
[0289] Alignment members 104 and 106 may extend from base 102 to align guide centerline CLG of guide 100 with bone centerline CLBS of the top surface of bone B (shown in FIG. 2). Each of alignment members 104 and 106 include continuous alignment edges 1004 and 1006. Edge 1004 is supported by substantially vertical struts 1007 and 1008. Edge 1006 is supported by substantially vertical struts 1010 and 1012. Edges 1004 and 1006 are substantially parallel to centerline CLG.
[0290] In some embodiments, alignment members may be or may include tines that correspond to struts 1007, 1008, 1010 and 1012. One or more of the tines may extend straight down from base 102. One or more of the tines may extend down and in the proximal direction relative to base 102. One or more of the tines may extend down and in the distal direction relative to base 102.
[0291] In embodiments that include one or more tines (not shown), edges 1004 and 1006 may be absent. In those embodiments, the tines may flex independently of each other. One or more of the tines may be biased away from guide centerline CLG. One or more of the tines may be biased toward guide centerline CLG. One or more of the tines may be curved or arcuate.
[0292] Some embodiments may include a bushing (not shown) in guide tube 120. The bushing may provide stability for a K-wire in procedures in which the K-wire is used as a drill to provide preliminary access to the inside of a bone.
[0293] FIG. 11 shows illustrative saw 1100. Saw 1100 may be used to cut an access hole at site H′ or site I′ (shown in FIG. 2) or any other suitable hole. Saw 1100 may be guided by guide 100 (shown in FIG. 1), guide 900 (shown in FIG. 9), guide 1900 (shown in FIG. 19) or any other suitable guide.
[0294] Saw 1100 may include wire 1102. Wire 1102 may be a K-wire or any other suitable wire. Saw 1100 may include centering sleeve 1104. Centering sleeve 1104 may be made of polymer, alloy or any other suitable material. Saw 1100 may include cutting member 1106. Cutting member 1106 may include teeth 1108, vents 1110 and cylindrical member 1112. Vents 1110 may provide chip clearance, side-cutting, reduced heating or other properties, among others. Saw 1100 may include torque adapter 1114. Torque adapter 1114 may transmit rotation from a rotation source to one or both of K-wire 1102 and cutting member 1106.
[0295] Wire 1102 may form an angled pilot hole in bone B. The hole may be formed at angle δ between saw axis Ls and bone axis LB. After wire 1102 penetrates bone B, saw 1100 may be advanced distally until teeth 1108 engage bone B and being to cut. Teeth 1108 will engage bone B first at point p, in the crotch between wire 1102 and bone B. Teeth 1108 may therefore be subjected to a contact force from bone B that is oblique to a plane defined by teeth 1108. Centering sleeve 1104 may support teeth 1108 against the oblique force and maintain teeth 1108 at a substantially constant radius from axis Ls during the formation of an access hole.
[0296] A spring 1116 (shown in FIG. 13) may urge centering sleeve 1104 distally to keep centering sleeve 1104 at or near bone B as teeth 1108 penetrate into bone B.
[0297] FIG. 12 shows that centering sleeve 1104 may be coaxially arranged within cutting member 1106. Wire 1102 may be coaxially arranged within centering sleeve 1104. Collar 1202 of centering sleeve 1104 may be provided at a distal end of centering sleeve 1104 to provide a close tolerance between wire 1102 and centering sleeve 1104.
[0298] FIG. 13 shows spring 1116 compressed between proximal face 1302 of centering sleeve 1104 and distal face 1304 of torque adapter 1114.
[0299] In some embodiments, wire 1102 may be used to drill a pilot hole in bone B without apparatus such as centering sleeve 1104 and cutting member 1106. In such embodiments, a bushing (not shown) may be provided in a guide tube such as guide tube 120 (shown in FIG. 1). Wire 1102 may be placed through the bushing and driven by a torque adapter such as 1114. The bushing may have a bore that is sized to stabilize a K-wire driven in rotation by a surgical drill.
[0300] It may be desirable thereafter to cut in the bone a hole that is substantially coaxial with the K-wire. After the K-wire is drilled into the bone, in such embodiments, the bushing (not shown) may be removed from the guide tube to allow a coring saw to advance through the guide tube.
[0301] FIG. 14 shows illustrative apparatus 1400 for cutting in bone B a hole that is substantially coaxial with wire 1402. FIG. 14 shows a relevant portion of coring saw guide 1450. Coring saw guide 1450 may include contacts 1452 for engaging a surface of bone B (shown in FIG. 2). Coring saw guide 1450 may include handle-mounting recesses such as 1454. A centering sleeve (not shown) may be disposed coaxially between wire 1402 and cutting member 1406. In some embodiments, a cutting member such as 1406 may be engaged by a collar (not shown) that is configured for delivery of torque.
[0302] A proximal end of wire 1402 may be engaged in a hand drill fitting and rotatingly driven into the bone as it is advanced distally through saw guide 1450.
[0303] FIG. 15 shows wire 1402. Distal end 1502 of wire 1402 may have a first diameter. Proximal end 1504 of wire 1402 may have a second diameter that is greater than the first diameter. Step 1506 between the first diameter and the second diameter may be used as a stop to limit the extent to which wire 1402 may be driven into bone B.
[0304] Proximal end 1504 of a wire such as 1402 may extend along and through a cannula in an A-O type adapter while the adapter drives a cutting member such as 1408 distally into a bone.
[0305] In some embodiments, step 1506 may be used to distally eject a bone plug from the interior of distal end 1405 of cutting member 1406 after a hole is cut and cutting member 1406 is withdrawn from the bone.
[0306] In some embodiments, a soft-tissue protector (not shown) may be provided to keep soft tissue proximate the access hole from becoming engaged by rotating apparatus. The protector may include a cannula for guiding the rotating apparatus into the hole. The protector may include a flange that “funnels” the apparatus into the cannula and blocks the soft tissue from approaching the apparatus.
[0307] FIG. 16 shows a portion of illustrative cutting member 1106 from region 16 of FIG. 11. A circumferential tooth 1602 may extend into one or more of vents 1110 to engage bone on the inside of the cutter.
[0308] Tooth 1602 may provide friction between cutting member 1106 and the bone plug and may facilitate removal of the bone plug upon with withdrawal of cutting member 1106 from the access hole. The distal end of the bone plug may not be severed from bone B native tissue by cutting member 1106. Tooth 1602 may provide one or both of torsional and axial force to sever the plug from bone B. Vents 1110 may include vent edges 1604. Vent edges 1604 may cut a wall of the access hole.
[0309] Tooth 1602 may provide friction between cutting member 1106 and centering sleeve 1104. The friction may resist proximal motion of centering sleeve 1104.
[0310] FIG. 17 shows illustrative teeth 1108 of cutter member 1106 (shown in FIG. 11). Illustrative tooth 1702 may include cutting edge 1704, face 1706 and back 1708. Face 1706 and back 1708 may partially define adjacent gullets 1710 and 1712, which intervene between tooth 1702 and neighboring teeth 1714 and 1716, respectively. Tooth 1702 may have thickness t. Tooth 1702 may be circumferentially set apart from neighboring tooth 1716 by pitch Pt. Cutting edge 1704 may be angled relative to saw radial direction Rs by bevel angle φ (shown on a different tooth). Cutting edge 1704 is shown with φ=0°, but any suitable φ may be used. Face 1706 may have longitudinal rake angle ρ.
[0311] Larger rake angles (e.g., positive) may produce lower forces, but smaller included tooth angles, and therefore lower heat capacity. Smaller rake angles (e.g., negative) may increase heat capacity and increase heat generated in shearing but increase cutting forces.
[0312] Face 1706 is shown with ρ=0°, but any suitable ρ may be used. Gullet 1710 may have gullet depth Dg.
[0313] In some embodiments, tooth 1702 may include facet 1718 (shown in broken line). When facet 1718 is present, tooth face 1706 may be shortened by distance h. Facet 1718 may have a normal (not shown) that is oriented at any suitable angle relative to axis Ls and radius Rs.
[0314] FIG. 18 shows teeth 1108 (shown in FIG. 11) as viewed along lines 18-18 (shown in FIG. 17). Cutting edge 1704 forms angle θ with saw outer wall 1802. Cutting edge 1704 is shown with θ≈90°, but any suitable θ may be used. For example, a tooth formed by cutting along chord Ch1 may create a cutting edge having θ>90°. A tooth formed by cutting along chord Ch2 may create a cutting edge having θ<90°.
[0315] In some embodiments, a cutting member may have bi-directionally cutting teeth. Each tooth such tooth may have a right and a left cutting edge. When the coring saw rotates clockwise, a right edge cuts. When the coring saw rotates counterclockwise, a left edge cuts.
[0316] FIG. 19 shows illustrative instrument guide 1900. Illustrative instrument guide 1900 may have one or more features in common with one or more of guide 100 (shown in FIG. 1) and guide 900 (shown in FIG. 9). Guide 1900 may be used to guide an instrument into bone B at a site such as H′ or I′ (shown in FIG. 2).
[0317] Guide 1900 may include base 1902. Base 1902 may be placed against bone B (shown in FIG. 2) at site H′. Base 1902 may include contacts (not shown), alignment members (not shown), cleats (not shown) or any other suitable features. Grip 1918 may extend from base 1902. Base 1902 may include pivot 1904. Pivot 1904 may pivotably support guide tube 1920. Guide tube 1920 centerline CLGT′ may be positioned at any suitable angle α′ relative to axis LH′ so that saw 1950 may be advanced through bone B (not shown) at angle α′. The intersection of axis LH′ and CLGT′ may substantially coincide with site H′ or site I′ for different values of α′. A practitioner may change angle α′ before or during penetration of saw 1950 into bone B. For example, a practitioner may initiate a pilot hole at α′≈0° and then change α′ to obtain the desired angle for the access hole.
[0318] Saw 1950 may include teeth 1952, flutes 1954, cannula 1956 or any other suitable features, including the features described and shown herein in connection with other saws.
[0319] FIG. 20 shows a view of a distal portion of broach 700 taken along lines 20-20 (shown in FIG. 7). Pin 703 may be located near the distal end of bracket 720. Pin 703 may fix the position of the distal end of broaching member 704. Pin 703 may support cylindrical form 705. Cylindrical form 705 may be coaxially mounted on pin 703. Cylindrical form 705 may support a spiral segment of broaching member 704. One or more distal portions of broaching member 704 may be welded or otherwise suitably fixed to cylindrical form 705.
[0320] Cylindrical form 705 may constrain or partially constrain the orientation of distal portions of broaching member 704. Cylindrical form 705 may be fixed relative to bracket 720. Cylindrical form 705 may be rotatable relative to bracket 720.
[0321] Broach head 702 may include end cap 701. Broaching member 704 may remove tissue that is generally proximal end cap 701. In some embodiments, member 704 may expand in such a manner as to extend distally of end cap 701. In such embodiments, the broaching member may remove tissue that is distal of end cap 701.
[0322] Reducing or minimizing the distance between the distal end of broaching member 704 and end cap 701 may allow broaching member 704 to remove tissue that is more immediately proximal end cap 701. End cap 701 may be positioned at the distal end of bracket 720. End cap 701 may be configured to have a smooth, atraumatic surface. Bracket 720 may be attached to drive shaft 730.
[0323] Shaft assembly 714 may include drive shaft 730. Drive shaft 730 may support bracket 720 at union 732. Drive shaft 730 may be secured to bracket 720 by pin 734. Drive shaft 730 may provide rotation to broach head 702.
[0324] Proximal ends 736 and 738 of broaching member 704 may be fixed to slide 740, which may be a tube. Proximal end 738 may be threaded through or keyed into windows 742 and 744 in slide 740. Proximal end 736 may be threaded through or keyed into slots 746 and 748 in slide 740. Slide 740 may slide relative to drive shaft 730 to expand and contract broaching member 704. Slide 740 is shown in the “contract” state, in which broaching member 704 is drawn close to bracket 720. Slide cover 750 may slide with slide 740. One or both of slide 740 and slide cover 750 may be translated along axis Lc by control hub 710 (shown in FIG. 7) or any other suitable position controller.
[0325] Slide cover 750 may remain stationary relative to drive shaft 730 when slide 740 slides relative to drive shaft 730. In embodiments in which slide cover 750 remains stationary when slide 740 moves, distal end 752 of slide cover 750 may limit the radial position of broaching member 704 at a fixed distance along drive shaft 730 and thus affect the deformation of broaching member 704 in the expanded state.
[0326] Broaching member 704 may undergo one or both of elastic and plastic deformation.
[0327] FIG. 21 shows a view of a distal portion of broach 700 taken along lines 20-20 (shown in FIG. 7) when broaching member 704 is in an expanded state. Broaching member 704 is shown as mainly circular. However, any desired shape may be able to be imparted in the expanded state such as but not limited to: square, triangular, oval, ellipsoid, teardrop, football, or any other suitable shape.
[0328] Different shapes may be obtained using several methods, such as utilizing a pre-set shape in a shape memory alloy, modifying the geometry of the member cross-section (along the member length) such that it preferentially bends in a desired manner, constraining broaching member 704 (e.g., in force, shear or moment) in a way that forces the expansion to take desired shape, having the final shape be that of the expanded geometry and the reduced or collapsed geometry be that of a higher strain configuration, and/or any other suitable method of forming a desired shape.
[0329] For example, largely or substantially preventing radial movement of broaching member proximal ends 736 and 738, and allowing movement of the distal end of broaching member 704 generally about pin 703 while elastically deforming broaching member proximal ends 736 and 738, due to reducing the distance between the distal end and proximal ends 736 and 738 of broaching member 704, may modify the geometry of broaching member 704 from a generally straight configuration to a generally eggbeater shape.
[0330] The deformation may relatively increase the distance between (a) sections 760 and 762 and (b) bracket 720. As this distance is increased, the swept-out volume of broaching member 704, as broaching member 704 rotates generally about an axis such as Lc (shown in FIG. 8), is increased.
[0331] In some embodiments, a broach may include a broaching member that includes one or more stiff tines (not shown) that is joined to a drive shaft. The drive shaft may have a longitudinal axis. The tine may be joined to the drive shaft radially close to the axis at a proximal end of the tine. The tine may have a distal end that is spaced radially apart from the axis. The distal end of the tine may be distal of the distal end of the drive shaft. There may be numerous tines on the drive shaft. Such embodiments may be appropriate for rotation in intramedullary space IS of bone B (shown in FIG. 2) using high torque at low rotational speeds.
[0332] FIG. 22 shows broaching member 704 in partial cross section from view lines 22-22 (shown in FIG. 21). Broaching member 704 may have leading edges 2202 and 2204 that may be rotated in direction ωc by drive shaft 730 (shown in FIG. 21). Broaching member 704 may sweep out a space in bone B (shown in FIG. 2) based on radius Rc, which corresponds to sections 760 and 762 (shown in FIG. 21).
[0333] Leading edge 2202 may be beveled at angle αc1. Angle αc1 may be any suitable angle, including an angle from about 5° to about 75°. Angle αc1 may cause leading edge 2202 to be generally sharp or knife-like. This may aid in the broaching member's ability to remove tissue.
[0334] Leading edge 2204 may be beveled at angle αc2. Angle αc2 may be any suitable angle, including an angle from about 5° to about 75°. Angle αc2 may cause leading edge 2204 to be generally sharp or knife-like. This may aid in the broaching member's ability to remove tissue.
[0335] As broaching member 704 is rotated clockwise generally about axis Lc leading edges 2202 and 2204 may generally be the first portion of sections 760 and 762 to come in contact with tissues such as relatively less dense cancellous bone BCA (shown in FIG. 2). Sections 760 and 762 may be configured to be sufficiently flexible such that if either of sections 760 and 762 contacts relatively more dense materials, such as diaphysis, metaphysis and epiphysis bone, sections 760 and 762 may deflect generally radially in direction −ωc about axis Lc and/or in the linear direction towards axis Lc at any location along the length of sections 760 and 762 or any other portion of broaching member 704. Deflection or deformation of sections 760 and 762 may have the affect of not disturbing the more dense tissues.
[0336] Leading edges 2202 and 2204 may be offset from axis Lc by offsets Δ1 and Δ2 respectively. Appropriate magnitudes of offsets Δ1 and Δ2 may be selected. In some embodiments, offsets Δ1 and Δ2 may be constrained by the collapsed diameter (overall diameter of broach head 702 in a plane transverse to axis Lc when broaching member 704 is collapsed, e.g., for deployment) of the configuration and the desired expanded engagement (radius Rc) of broaching member 704 with the tissue. Offsets Δ1 and Δ2 may aid in the broaching member's efficiency at displacing tissue.
[0337] FIG. 22A shows broach head 704 in intramedullary space IS of bone B and illustrates how flexible broaching members can broach bone of a relatively lower density and be deflected by bone of a relatively higher density. Sections 760 and 762 have displaced or removed some of cancellous bone BCA from bone B by rotating in direction ωc about axis Lc. Sections 760 and 762 may be sufficiently stiff to remove cancellous bone to radius Rc from axis Lc in the “top” portion of bone B. Because of the placement of axis L; relative to the bottom portion of bone B, sections 760 and 762 contact cortical bone BCO at the bottom of bone B. Sections 760 and 762 may be sufficiently flexible to be deflected by cortical bone BCO. Section 760 is shown deflected in direction −ωc by bone BCO. Sections 760 and 762 thus remove bone only to radius Rc′ in the “bottom” portion of bone B.
[0338] The cavity created by broach 700 may thus be bounded in part by cancellous bone BCA and in part by cortical bone BCO. The shape of the cavity portion that is bounded by cancellous bone BCA may be governed substantially by the geometry and mechanical properties of broach 700. The shape of the cavity portion that is bounded by cortical bone BCO may be governed substantially by the native anatomy of bone B.
[0339] FIG. 23 shows a view of broach 700 along lines 23-23 (shown in FIG. 20). Broach 700 is in the contracted state. Slide cover 750 has been removed. Slots 746, 748 and 2302 in slide 740 may be configured to coincide with features on proximal end 736 (shown in FIG. 21) of broaching member 704. When proximal end 736 is engaged with slots 746, 748 and 2302, slots 746, 748 and 2302 may restrict movement of proximal end 736 in either direction generally along axis Lc. Slots 746, 748 and 2302 may have any suitable geometry that allows for the engagement and axial translation of proximal end 736.
[0340] Slots 746, 748 and 2302 may be of sufficient depth that, when proximal end 736 is engaged in slots 746, 748 and 2302, slide cover 750 (shown in FIG. 20) has adequate radial clearance with respect to proximal end 736 and slide 740 to slide over slide 740 and slots 746, 748 and 2302. An inner surface of slide cover 750 may prevent movement of proximal end 736 from moving in a direction generally away from axis Lc.
[0341] Slide 740 may include slots (not shown) that correspond to proximal end 738 (shown in FIG. 20) and have one or more features in common with, slots 746, 748 and 2302.
[0342] Broach head 720 may include broaching member wrap section 2304. Pin 703 may be integrated into wrap section 2304. Wrap section 2304 may be separate from pin 703. Wrap section 2304 may be configured to allow wrapping of broaching member 704 generally around wrap section 2304. Broaching member 704 may be looped in wrap section 2304. Broaching member 704 may be wrapped (as shown in FIG. 23) at least one full turn in wrap section 2304. Wrapping about wrap section 2304 may bias segments 760 and 762 (shown in FIG. 21) away from axis Lc.
[0343] FIG. 24 shows a cross section, viewed along lines 24-24 (shown in FIG. 8) of a portion of broach control 706 (shown in FIG. 7). Expansion control hub 710 is shown with base 2402 at position pe. This may correspond to the expanded state of broaching member 704, as shown in FIG. 8. Base 2402 may be moved distally to position pc. This may correspond to the contracted state of broaching member 704, as shown in FIG. 7. Expansion control hub 710 may operate in connection with body 2408. Body 2408 may include control shaft 712 and distal stop 2410. Control shaft 712 may include threads 2418.
[0344] Expansion control hub 710 may include outer member 2412 and inner member 2414. Outer member 2412 and inner member 2414 may be fixed to each other. Slide pin 2404 may be captured between outer member 2412 and inner member 2414. Inner member 2414 may include threads 2416 for engagement with threads 2418 on control shaft 712. Slide pin 2404 may travel in slots 2405 and 2407 in body 2408.
[0345] Expansion control hub 710 may be moved along axis Lc by applying force to expansion control hub 710. In some embodiments, expansion control hub 710 may be advanced axial generally along axis Lc by applying rotational force generally about axis Lc to expansion control hub 710 such that threads 2416 move advance or retreat through threads 2418.
[0346] Axial movement of expansion control hub 710 relative to body 2408 may be transferred to slide 740 and slide cover 750 while drive shaft 730 remains axially fixed to body 2408 by pin 2406. Slide 740 may include cut-outs 2430 and 2432. Slide cover 750 may include cut-outs 2434 and 2436. Cut-outs 2430, 2432, 2434 and 2436 may provide clearance of pin 2406 when slide 740 and slide cover 750 travel axially.
[0347] When expansion control hub 710 is moved axially, proximal ends 736 and 738 (shown in FIG. 20) of broaching member 704 thus move axially. Distal end 780 (shown in FIG. 7) of broaching member 704 may be axially fixed to drive shaft 730, which may be fixed to body 2408. Thus, when expansion control hub 710 moves distally, the distance between (a) proximal ends 736 and 738 and; (b) distal end 780 decreases and broaching member 704 expands. When expansion control hub 710 moves proximally, the distance between (a) proximal ends 736 and 738; and (b) distal end 780 increases and broaching member 704 contracts.
[0348] Distal stop 2410 and proximal stop 2420 may limit axial movement of expansion control hub 710. Although proximal stop 2420 is shown as being part of handle 708, proximal stop 2420 may be separate from handle 708.
[0349] Handle 708 may transfer rotational motion generally about axis Lc to control shaft 712. Control shaft 712 may transfer the rotation to slide pin 2404 and drive shaft pin 2406. Slide pin 2404 may transfer the rotation to slide 740 and slide cover 750. Drive shaft pin 2406 may transfer the rotation to drive shaft 730, which may drive broaching member 704 (shown in FIG. 21).
[0350] Distal stop 2410 is shown as being integral with body 2408, but distal stop may be a separate element that is attached to control shaft 712 or a different part of body 2408.
[0351] Pin 2406 may extend into recess feature 2422. Recess feature 2422 may be a through-hole. Pin 2406 may extend through the through hole to a location external to body 2408.
[0352] Pin 2404 may extend into recess feature 2424. Recess feature 2424 may be a through-hole. Pin 2404 may extend through the through-hole to a location external to body outer member 2412. Recess feature may extend circumferentially about axis Lc. If recess feature 2424 extends circumferentially about axis Lc, expansion control hub 710 may rotate about axis Lc substantially without restricting, or being restricted by, pin 2404.
[0353] Body 2408 may include circumferential recess 2426. Recess 2426 may be sized to engage O-ring 2428. Recess 2426 may prevent axial movement between body 2408 and O-ring 2428 generally along axis Lc. O-ring 2428 may be sized to provide an interference fit with outer member 2412. The interference fit may produce friction between O-ring 2428 and expansion control hub 710. The friction may allow expansion control hub 710 to be lightly locked at any rotational position relative to body 2408, generally about axis Lc.
[0354] FIG. 25 shows illustrative cavity preparation apparatus 2500. Apparatus 2500 may include broach 2550. Broach 2550 may have one or more features in common with broach 950 (shown in FIG. 9). Broach 2550 may include one or more of broach head 2525, elevator ribbon 2552 and control body 2560. Apparatus 2500 may include guide 2502. Guide 2502 may guide broach 2550 or any other suitable apparatus through an access hole such as H or I (shown in FIG. 2). Guide 2502 may retain soft tissue at a distance from the access hole to prevent engagement of the soft tissue by an instrument that is present in guide 2502.
[0355] FIGS. 26-29 show features of different portions of apparatus 2500.
[0356] FIG. 26 shows in partial cross section illustrative broach head 2525 and illustrative elevator ribbon 2552.