Apparatus And Methods For Fracture Repair

  *US09788870B2*
  US009788870B2                                 
(12)United States Patent(10)Patent No.: US 9,788,870 B2
  et al. (45) Date of Patent:Oct.  17, 2017

(54)Apparatus and methods for fracture repair 
    
(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.: 13/892,476 
(22)Filed: May  13, 2013 
(65)Prior Publication Data 
 US 2014/0128870 A1 May  8, 2014 
 Related U.S. Patent Documents 
(63) .
Continuation of application No. 13/625,680, filed on Sep.  24, 2012, now abandoned , which is a continuation of application No. 12/353,855, filed on Jan.  14, 2009, now Pat. No. 8,287,538 .
 
(60)Provisional application No. 61/090,999, filed on Aug.  22, 2008.
 
 Provisional application No. 61/020,778, filed on Jan.  14, 2008.
 
Jan.  1, 2013 A 61 B 17 7225 F I Oct.  17, 2017 US B H C Jan.  1, 2013 A 61 B 17 725 L I Oct.  17, 2017 US B H C Jan.  1, 2013 A 61 B 17 7233 L I Oct.  17, 2017 US B H C Jan.  1, 2013 A 61 B 17 7258 L I Oct.  17, 2017 US B H C Jan.  1, 2013 A 61 B 17 7275 L I Oct.  17, 2017 US B H C Jan.  1, 2013 A 61 B 17 863 L I Oct.  17, 2017 US B H C Jan.  1, 2013 A 61 B 17 869 L I Oct.  17, 2017 US B H C Jan.  1, 2013 A 61 B 17 8858 L I Oct.  17, 2017 US B H C Jan.  1, 2013 A 61 B 17 70 L A Oct.  17, 2017 US B H C Jan.  1, 2013 A 61 B 17 7097 L A Oct.  17, 2017 US B H C Jan.  1, 2013 A 61 B 2017 8655 L A Oct.  17, 2017 US B H C
(51)Int. Cl. A61B 017/56 (20060101); A61B 017/58 (20060101); A61F 002/30 (20060101); A61B 017/72 (20060101); A61B 017/86 (20060101); A61B 017/88 (20060101); A61B 017/70 (20060101)
(58)Field of Search  606/62-64, 300-321

 
(56)References Cited
 
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 6,238,417  B1  5/2001    Cole     
 6,241,734  B1  6/2001    Scribner et al.     
 6,248,110  B1  6/2001    Reiley et al.     
 6,258,096  B1  7/2001    Seki     
 6,261,289  B1  7/2001    Levy     
 6,280,474  B1  8/2001    Cassidy et al.     
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 6,299,642  B1  10/2001    Chan     
 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.     
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 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     
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 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 et al.     
 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.     
 6,746,451  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.     
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 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.     
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 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.     
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 7,122,043  B2  10/2006    Greenhalgh et al.     
 7,122,052  B2  10/2006    Greenhalgh     
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 7,137,987  B2  11/2006    Patterson et al.     
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 7,153,307  B2  12/2006    Scribner et al.     
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 7,160,331  B2  1/2007    Cooney et al.     
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 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     
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 7,267,678  B2  9/2007    Medoff     
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 7,294,130  B2  11/2007    Orbay     
 7,300,449  B2  11/2007    Mische et al.     
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 7,306,683  B2  12/2007    Cheung et al.     
 7,311,711  B2  12/2007    Cole     
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 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     
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 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.     
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 7,588,575  B2  9/2009    Colleran et al.     
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 7,601,152  B2  10/2009    Levy et al.     
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 7,621,950  B1  11/2009    Globerman et al.     
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 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.     
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 7,722,612  B2  5/2010    Sala et al.     
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 7,758,500  B2  7/2010    Boyd et al.     
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 7,909,827  B2  3/2011    Reiley et al.     
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 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.     
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 RE42,757  E  9/2011    Kuslich et al.     
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 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     
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 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.     
 8,287,539  B2  10/2012    Nelson et al.     
 8,287,541  B2  10/2012    Nelson et al.     
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 8,366,773  B2  2/2013    Schaller et al.     
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 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     
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 2001//0034526  A1  10/2001    Kuslich et al.     
 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 Hoffman et al.     
 2002//0143334  A1  10/2002    Hoffmann et al.     
 2002//0143335  A1  10/2002    von Hoffman et al.     
 2002//0147451  A1  10/2002    Mcgee     
 2002//0147455  A1  10/2002    Carson     
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 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     
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 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//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     
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 2004//0230193  A1  11/2004    Cheung et al.     
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 2004//0260297  A1  12/2004    Padget et al.     
 2004//0267269  A1  12/2004    Middleton et al.     
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 2005//0065524  A1  3/2005    Orbay     
 2005//0065526  A1  3/2005    Drew et al.     
 2005//0070902  A1  3/2005    Medoff     
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 2005//0234472  A1  10/2005    Huebner     
 2005//0240188  A1  10/2005    Chow et al.     
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 2005//0277936  A1  12/2005    Siravo et al.     
 2005//0277978  A1  12/2005    Greenhalgh     
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 2006//0004462  A1  1/2006    Gupta     
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 2006//0089647  A1  4/2006    Culbert et al.     
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 2006//0122600  A1  6/2006    Cole     
 2006//0122610  A1  6/2006    Culbert et al.     
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 2006//0142858  A1  6/2006    Colleran et al.     
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 2006//0189994  A1  8/2006    Wolford et al.     
 2006//0195103  A1  8/2006    Padget et al.     
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 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     
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 2007//0123886  A1  5/2007    Meyer et al.     
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 2007//0173835  A1  7/2007    Medoff et al.     
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 2007//0179505  A1  8/2007    Culbert     
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 2007//0219634  A1  9/2007    Greenhalgh et al.     
 2007//0225568  A1  9/2007    Colleran     
 2007//0225721  A1  9/2007    Thelen et al.     
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 2007//0225810  A1  9/2007    Colleran et al.     
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 2007//0244485  A1  10/2007    Greenhalgh et al.     
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 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.     
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 2008//0194868  A1  8/2008    Kozyuk     
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 2008//0200915  A1  8/2008    Globerman et al.     
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 2008//0208261  A1  8/2008    Medoff     
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 2008//0212405  A1  9/2008    Globerman et al.     
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 2008//0269742  A1  10/2008    Levy et al.     
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 2008//0269748  A1  10/2008    Justin et al.     
 2008//0269749  A1  10/2008    Shalaby et al.     
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 2008//0269776  A1  10/2008    Justin et al.     
 2008//0275448  A1  11/2008    Sackett et al.     
 2008//0275449  A1  11/2008    Sackett et al.     
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 2008//0287951  A1  11/2008    Stoneburner et al.     
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 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.     
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 2009//0018656  A1  1/2009    Clifford et al.     
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 2009//0024204  A1  1/2009    Greenhalgh et al.     
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 2009//0131952  A1  5/2009    Schumacher et al.     
 2009//0131992  A1  5/2009    Greenhalgh et al.     
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 2009//0149956  A1  6/2009    Greenhalgh et al.     
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 2014//0074093  A9  3/2014    Nelson et al.     
 2015//0012096  A1  1/2015    Krinke et al.     
 2015//0141996  A1  5/2015    Taylor et al.     
 2015//0164514  A1  6/2015    Wlodarski et al.     

 
 FOREIGN PATENT DOCUMENTS 
 
       CA       2007210       A1                11/1990      
       CA       2452508       A1                1/2003      
       CA       2609175       A1                12/2005      
       CA       2608693       A1                11/2006      
       CA       2537171       C                7/2007      
       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       101636119       A                1/2010      
       DE       923085                         2/1955      
       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       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       1535579       A2                1/2005      
       EP       1148825       B1                3/2005      
       EP       1148850       B1                4/2005      
       EP       1522268       A1                4/2005      
       EP       1227765       B1                5/2005      
       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      
       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       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       WO99/37219       A1                7/1999      
       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       WO02/067824       A2                9/2002      
       WO       WO02/078555       A1                10/2002      
       WO       WO02/089683       A1                11/2002      
       WO       WO02/096306       A1                12/2002      
       WO       WO03/007830       A1                1/2003      
       WO       WO03/013336       A2                2/2003      
       WO       WO02/017794       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       WO02/017794       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       WO20/05039651       A2                5/2005      
       WO       WO20/05041799       A1                5/2005      
       WO       WO20/05044122       A1                5/2005      
       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      
       WO       WO20/06026323       A2                3/2006      
       WO       WO20/06026323       A9                4/2006      
       WO       WO20/06041460       A1                4/2006      
       WO       WO20/06041460       A1                4/2006      
       WO       WO20/06042188       A2                4/2006      
       WO       WO20/06042189       A2                4/2006      
       WO       WO20/06042334       A2                4/2006      
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     * cited by examiner
 
     Primary Examiner —Ellen C Hammond
     Assistant Examiner —Christina Negrellirodrigue
     Art Unit — 3733
     Exemplary claim number — 1
 
(74)Attorney, Agent, or Firm — Weiss & Arons LLP

(57)

Abstract

Apparatus and methods for bone fracture repair. The apparatus may include a structural support for positioning a first bone segment relative to a second bone segment. The apparatus may include an anchoring substrate. The anchoring substrate may be configured to compress the first bone segment to the second bone segment. The anchoring substrate may transmit tension from a distal bone segment anchor in the first bone segment to a proximal bone segment anchor in the second bone segment. The apparatus may be configured to be deployed percutaneously in an inner cavity of a bone. The apparatus may be installed in an open fracture. The apparatus may be expanded, self-expanding or configured for mechanically actuation. Some embodiments of the apparatus may include a central axis member that may be used in conjunction with expansion of one or both of the structural support and the anchoring substrate to configure the apparatus.
96 Claims, 54 Drawing Sheets, and 77 Figures


CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of U.S. patent application Ser. No. 13/625,680, filed on Sep. 24, 2012, which is a continuation of U.S. patent application Ser. No. 12/353,855, filed on Jan. 14, 2009, now U.S. Pat. No. 8,287,538, which is a nonprovisional U.S. Provisional Applications Nos. 61/020,778, filed on Jan. 14, 2008, and 61/090,999, filed on Aug. 22, 2008, 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] Currently, there are many known ways to treat long bone fractures. Common fracture treatments include: (1) non-surgical immobilization; (2) osteosuture and tension band technologies; (3) percutaneous fixation (e.g., using pins, wires, screws etc.); (4) rigid intramedullary nailing (e.g., using a large rod and external screws); (5) flexible plate osteosynthesis (e.g., a “load sharing” suture); (6) arthroplasty (e.g., using a prosthesis); (7) plating and other indication-specific techniques. Severe fractures that meet certain clinical criteria may require surgical repair rather than non-surgical immobilization.
[0004] The midshaft of an elongated or long bone is typically classified as the diaphysis. The end of such a bone is typically classified as the epiphysis. Bone that is transitional between the midshaft and the end is typically classified as the metaphysis.
[0005] Metaphysis and epiphysis bone are typically less dense, more cancellous (porous), and less cortical than diaphysis bone. Repair of metaphysis and epiphysis fractures are often complicated by their proximity to a joint. Because of such bone quality and anatomical differences, fixation of plates and screws in metaphysis and epiphysis bone is typically more difficult than fixation of plates and screws in diaphysis bone. This may be especially true if the patient is elderly and suffers from osteoporosis.
[0006] 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.
[0007] There are two primary categories for surgical fixation: (1) a device that is within the skin (internal fixation); and (2) a device that extends out of the skin (external fixation). There are two common types of internal fixation approaches for long bone surgery (a) a plate that is screwed to the outside of the bone; or (b) a rod that goes down the center of the bone.
[0008] Plates and screws are characterized by relatively invasive surgery, support of fractured bone segments from one side outside of bone, and screws that anchor into the plate and through the entire bone. Successful repair is dependent on fracture pattern, bone quality, physician skill set, and patient tolerance of a foreign body. Plates and screws may not properly address the alignment and stability requirements for periarticular and intrarticular fractures.
[0009] Intramedullary rods or nails, such as those used in mid shaft treatments, are more effective than plates and screws at minimizing soft-tissue trauma and complications. However, rods and nails often do not stabilize multi-segment fractures in many cases. The typical intramedullary rod or nail is fixed in diameter and is introduced into the medullary canal through an incision. In cases where there is a medullary plenum larger than the rod, rotational and transverse stability may be compromised. If a larger rod is used, reaming of the entire shaft length may be necessary. Such reaming may thin out existing cortical bone support. Also, predetermined threaded screw holes in the rods may limit the ways in which different fracture patterns can be reduced and stabilized.
[0010] Flexible intramedullary rod-like solutions utilize structures that can be inserted into the medullary cavity through an access site, which can then become rigid. These solutions may be easier for the user to install than rigid intramedullary rods. These structures may be reinforced with polymers or cements. Flexible intramedullary solutions, similar to rigid intramedullary rods, may have limited benefits for periarticular or intrarticular fractures. Multi-segment fractures, of either the midshaft or end-bone, require alignment and stability in a manner that generates adequate fixation in multiple directions.
[0011] Midshaft fractures and end-bone fractures are fundamentally different. The loading conditions, fracture patterns, alignment needed, and compression force to promote healing are different. Midshaft fractures 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 minimal anchoring locations.
[0012] Midshaft fractures tend to be loaded primarily in bending and torsion. End-bone fractures tend to be loaded in complex and multi-directional stress patterns. Midshaft repair approaches, therefore, may not be appropriate for repair of end-bone fractures.
[0013] Appropriate sizing of an implant helps realignment and healing of the fracture. As a result, many different sizes of known repair products are often stored in inventories to ensure proper matching of the implant device to a patient's anatomy. The inventories may be a burden to hospitals and insurance carriers, but they may be necessary to provide to a surgeon intraoperative flexibility.
[0014] It would be desirable, therefore, to provide apparatus and methods for proper anatomic alignment and stabilization, while reducing trauma and complications.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] 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:
[0016] FIG. 1 is a side view of apparatus in accordance with the principles of the invention disposed;
[0017] FIG. 1A is a perspective view of the apparatus shown in FIG. 1;
[0018] FIG. 1B is a partial sectional view of the apparatus shown in FIG. 1A;
[0019] FIG. 1C is front view of the apparatus shown in FIG. 1A in accordance with the principles of the invention;
[0020] FIG. 2 is a front view of an illustrative human skeleton;
[0021] FIG. 3 is a partial sectional view of a fractured bone;
[0022] FIG. 4 is a perspective view showing a body portion that may be treated using the apparatus shown in FIG. 1;
[0023] FIG. 5 is a perspective view showing the a portion of the body portion shown in FIG. 4;
[0024] FIG. 6 is a sectional view of apparatus in accordance with the principles of the invention;
[0025] FIG. 7 is a sectional view of apparatus shown in FIG. 6 along with additional apparatus in accordance with the principles of the invention;
[0026] FIG. 8 is a sectional view of apparatus shown in FIG. 1 along with additional apparatus in accordance with the principles of the invention;
[0027] FIG. 9 is a partial sectional view of apparatus shown in FIG. 1 along with additional apparatus in accordance with principles of the invention;
[0028] FIG. 10 is a partial sectional view showing the use of the apparatus shown in FIG. 1 along with additional apparatus in accordance with the principles and methods of the invention;
[0029] FIG. 11 is a partial sectional view of the apparatus shown in FIG. 1 along with additional apparatus in accordance with the principles of the invention;
[0030] FIG. 12 is a partial sectional view of the apparatus shown in FIG. 1 along with additional apparatus in accordance with the principles of the invention;
[0031] FIG. 13 is a partial sectional view of the apparatus shown in FIG. 1 along with additional apparatus in accordance with the principles of the invention;
[0032] FIG. 14 is a partial sectional view of the apparatus shown in FIG. 1 along with additional apparatus in accordance with the principles of the invention;
[0033] FIG. 15 is a partial sectional view of the apparatus shown in FIG. 1 along with additional apparatus in accordance with the principles of the invention;
[0034] FIG. 16 is a partial sectional view of the apparatus shown in FIG. 1 along with additional apparatus in accordance with the principles of the invention;
[0035] FIG. 17 is a partial sectional view of the apparatus shown in FIG. 1 along with additional apparatus in accordance with the principles of the invention;
[0036] FIG. 18 is a partial sectional view of apparatus in accordance with the principles of the invention;
[0037] FIG. 19 is a perspective view of apparatus in accordance with the principles of the invention;
[0038] FIG. 20 is a partial sectional view of apparatus in accordance with the principles of the invention;
[0039] FIG. 21 is an end view of the apparatus shown in FIG. 20;
[0040] FIG. 22 is a partial sectional view of apparatus shown in FIG. 1;
[0041] FIG. 23 is a perspective view of apparatus in accordance with the principles of the invention;
[0042] FIG. 24 is a partial sectional view of the apparatus shown in FIG. 23;
[0043] FIG. 25 is a side view of apparatus in accordance with the principles of the invention;
[0044] FIG. 26 is a side view of apparatus in accordance with the principles of the invention;
[0045] FIG. 27 is a perspective view of apparatus in accordance with the principles of the invention;
[0046] FIG. 28A is a side view of apparatus in accordance with the principles of the invention;
[0047] FIG. 28B is a side view of apparatus in accordance with the principles of the invention;
[0048] FIG. 28C is a partial sectional view of apparatus in accordance with the principles of the invention;
[0049] FIG. 29 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0050] FIG. 30 is sectional view of a portion of the apparatus shown in FIG. 29;
[0051] FIG. 31 is a side view of apparatus in accordance with the principles of the invention;
[0052] FIG. 32 is a sectional view of apparatus shown in FIG. 31;
[0053] FIG. 33 is a perspective view of apparatus in accordance with the principles of the invention;
[0054] FIG. 34 is a perspective view of apparatus in accordance with the principles of the invention;
[0055] FIG. 35 is a perspective view of apparatus in accordance with the principles of the invention;
[0056] FIG. 36 is a perspective view of apparatus in accordance with the principles of the invention;
[0057] FIG. 37 is a perspective view of apparatus in accordance with the principles of the invention;
[0058] FIG. 38 is a perspective view of apparatus in accordance with the principles of the invention;
[0059] FIG. 39 is a perspective view of apparatus in accordance with the principles of the invention;
[0060] FIG. 40 is a partial sectional view of apparatus shown in FIG. 39;
[0061] FIG. 41 is a perspective view of apparatus in accordance with the principles of the invention;
[0062] FIG. 42 is a perspective view of apparatus in accordance with the principles of the invention;
[0063] FIG. 43 is a perspective view of apparatus in accordance with the principles of the invention;
[0064] FIG. 44 is a perspective view of apparatus in accordance with the principles of the invention;
[0065] FIG. 45 is a perspective view of apparatus in accordance with the principles of the invention;
[0066] FIG. 46 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0067] FIG. 47 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0068] FIG. 48 is a perspective view of apparatus in accordance with the principles of the invention;
[0069] FIG. 49 is a perspective view of apparatus in accordance with the principles of the invention;
[0070] FIG. 50 is a perspective view of apparatus in accordance with the principles of the invention;
[0071] FIG. 51 is a perspective view of apparatus in accordance with the principles of the invention;
[0072] FIG. 52 is a perspective view of apparatus in accordance with the principles of the invention;
[0073] FIG. 53 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0074] FIG. 54 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0075] FIG. 55 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0076] FIG. 56A is a perspective view of apparatus in accordance with the principles of the invention;
[0077] FIG. 56B is a side view of the apparatus shown in FIG. 56A;
[0078] FIG. 56C is an end view of the apparatus shown in FIG. 56A;
[0079] FIG. 57A is a perspective view of apparatus in accordance with the principles of the invention;
[0080] FIG. 57B is a side view of the apparatus shown in FIG. 57A;
[0081] FIG. 57C is an end view of the apparatus shown in FIG. 57A;
[0082] FIG. 58 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0083] FIG. 59 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0084] FIG. 60 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0085] FIG. 61 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0086] FIG. 62 is a perspective view of apparatus in accordance with the principles of the invention;
[0087] FIG. 63 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0088] FIG. 64 is a side view of apparatus in accordance with the principles of the invention inside a body portion;
[0089] FIG. 65 is a perspective view showing the use of apparatus in accordance with the principles of the invention;
[0090] FIG. 66 is a perspective view of apparatus in accordance with the principles of the invention;
[0091] FIG. 67 is a perspective view of apparatus in accordance with the principles of the invention; and
[0092] FIG. 68 is an illustrative flow diagram that shows a method in accordance with the principles of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0093] Apparatus and methods for fracture repair are provided. The apparatus may include a structural support for positioning a first bone segment relative to a second bone segment. The structural support may be configured to be deployed in an inner cavity of a bone. The apparatus may include an anchoring substrate. The anchoring substrate may be configured to compress the first bone segment to the second bone segment. The anchoring substrate may be configured to be deployed in the inner cavity.
[0094] The term “bone segment” may refer to portions or fragments of a bone. The term “structural support” may include a “structural cage.”
[0095] The structural support may be self-expanding. The structural support may be expanded by balloon. The structural support may be expanded by mechanical actuation. The anchoring substrate may be self-expanding. The anchoring substrate may be expanded by balloon. The anchoring support may be expanded by mechanical actuation.
[0096] The structural support may be used as a frame to position and align the bone segments. Anchors may used to secure the bone segments to the anchoring substrate. The anchoring substrate may be tensioned to compress the bone segments against each other. Some embodiments of the apparatus may include a central axis member. The central axis member may be used in conjunction with expansion of one or both of the structural support and the anchoring substrate. The central axis member may be used in conjunction with the tensioning of the anchoring substrate after anchors are placed. A proximal anchor may be used to fix one end of the apparatus to a bone segment to “lock in” the tensioning of the anchoring substrate.
[0097] The apparatus may include delivery apparatus. The delivery apparatus may deliver one or more portions of the apparatus, such as the structural support and the anchoring substrate, through an access hole in the bone and into the intramedullary cavity in the bone. The portions may be delivered in a contracted or collapsed state. The portions may then be expanded for repair of the fracture.
[0098] The apparatus and methods may involve reducing, aligning, compressing and/or stabilizing the fracture from within the intramedullary cavity. In some instances, the resulting stabilized bone may then heal while maintaining mobility of the patient.
[0099] The apparatus and methods may provide stabilization in axial bending, torsion, rotation, compression, and may provide inter-segment tension or compression.
[0100] The stabilization may repair compacted and impacted fractures, control length, and control alignment of the fracture segments. The apparatus may separate the tasks of revision, reduction, fixation, stabilization, rotation and offset.
[0101] The apparatus and methods may distribute load between the apparatus and native bone. The apparatus may have flexibility and modulus that are similar to native bone. Some embodiments may provide apparatus that is selectively weaker than or stronger than the native bone to promote beneficial fracture healing response.
[0102] The apparatus and methods may be used for closed reduction, open reduction, and minimally invasive surgical procedures (“MIS”). The apparatus and methods may facilitate arthroscopic surgical procedures. The apparatus and methods may provide percutaneous fracture repair. In such repair, the apparatus may be deployed into the cavity of a bone through a small incision.
[0103] The apparatus may be delivered at a point other than that of the fracture site. This may help reduce soft tissue damage. The apparatus may be delivered into an intramedullary cavity through a small access hole that may be placed along the midshaft of the long bone in an area in which minimal soft tissues would need to be displaced.
[0104] The apparatus and methods may reduce the need to place foreign bodies in muscle, tendon and nerve areas. As such, the apparatus and methods may reduce tissue erosion and disintegration. Preservation of the soft tissue may reduce chronic pain and stiffness. The apparatus and methods may reduce infection risk because of its noninvasiveness.
[0105] In some embodiments, the apparatus and methods may be made completely from biologically friendly metals such as titanium and Nitinol. Such materials reduce the risk of infection and do not generally interfere with normal biological processes within the fractured bone.
[0106] The apparatus and methods may be used to repair many different types of bones. For example, the apparatus and methods may be used to repair long bones, short bones, flat bones, irregular bones, and sesamoid bones.
[0107] The apparatus and methods may be used to repair many different types of fractures. For example, the apparatus and methods may be used to repair comminuted fractures, epiphyseal fractures, metaphyseal fractures, mid shaft fractures, intra-articular fractures, periarticular fractures, multipart fractures and other types of fractures.
[0108] The apparatus may be used in the reconstruction of fractured joints. The apparatus and methods may also facilitate such joint replacements by providing an adequate anchoring substrate. For example, the apparatus and methods may provide stable anchoring for a prosthesis, and reduce aseptic loosening.
[0109] The terms “end-bone” and “end-bone fracture” may be used to refer to fractures that occur in the epiphyseal or metaphyseal region of long bones. Such fractures include peri-articular and intra-articular fractures.
[0110] The apparatus and methods may be used to treat osteoporotic bone, indications involving poor bone quality. In connection with such indications, the apparatus may compensate for deficiencies in native bone and may reduce concerns regarding stress shielding. The apparatus and methods may be used in connection with fusion of bones and joints for various indications including arthritis.
[0111] The apparatus and methods may be used in conjunction with bone cement or in place of bone cement. In some embodiments, the apparatus may act as a bone filler. For example, the apparatus may be used for filling bone void in connection with the treatment of cysts and tumors. The apparatus may behave as an osteoconductive scaffold to promote bone growth.
[0112] The apparatus and methods may be used in connection with provisional alignment for staged repair procedures, such as revisions, high energy trauma, or other cases in which there is infection or soft tissue that needs to heal before bone fixation is completed. The apparatus and methods may be used in combination with various antibiotics that promote healing.
[0113] The structural support may prevent bone segments from moving inward, so the apparatus may reduce the likelihood of collapse of the fracture. The apparatus may conform to the shape of bone and may thus minimize undue stresses. For example, the apparatus and methods may reduce hoop stress by selecting a degree of implant expansion or stiffness.
[0114] The apparatus may be self-centering, because it expands into the bone cavity. Many of the cavities are not straight like a pipe; they vary depending on the anatomy. The apparatus may be straight, bent, curved, and cavity-compliant.
[0115] The apparatus and methods may provide anchoring at the distal end of the apparatus. This feature may be used for repairs of articular fractures and fractures with small or mobile bone segments.
[0116] The apparatus and methods may provide for the use of small anchors, because the apparatus provides structural support for the bone segments that require anchoring.
[0117] The apparatus and methods may provide anchoring in any suitable direction. Some embodiments may provide anchoring in any plane.
[0118] Because the anchoring substrate expands toward the inside surface of the bone segments, relatively shorter anchors may be used in comparison with typical repair methods. For the same reason, the use of a screw that is longer than required to engage the anchoring substrate will not result in driving the screw into or through bone that is opposite the anchored segment. This is so because the screw will terminate in the intramedullary cavity.
[0119] The apparatus and methods may be used in conjunction with plates, screws, pins, external fixators, replacement joints, bone graft matrices, factor based bone substitutes, and cell based bone substitutes.

Delivery Instrument

[0120] The delivery instrument may deliver the apparatus to the intramedullary cavity through an access hole in the bone. The delivery instrument may be used to remove the apparatus from the intramedullary cavity through the access hole. The delivery instrument may engage the apparatus by any suitable mechanism, including one or more of threading, a socket, a pin, a snap, a collet, a cable, and any other suitable mechanism.
[0121] The mechanism may deliver, expand, adjust, rotate, lock, release and recapture the apparatus. Each of the acts, and other suitable acts, may be performed independently on the structural cage, the anchor substrate, the central axis member, locking features, and associated coupling mechanisms. The delivery device may include a handle set capable of delivering the forces needed to actuate the mechanism or mechanisms.
[0122] The delivery instrument may include a sheath to help deliver the apparatus in a compacted state. The shaft of sheath may be bendable to access the intramedullary cavity. In some embodiments, the delivery instrument may not have a sheath. In those embodiments, the delivery instrument may push the apparatus into place unguarded.
[0123] The delivery instrument may be radio opaque in whole or in part.
[0124] In some embodiments, the delivery instrument may be attached to a flexible scope or endoscope. In some embodiments, the delivery instrument may be integrated with the flexible scope or endoscope.

Structural Support

[0125] The structural support may provide one or more of axial, bending, torsional, and positional structural support to the fracture segments. The structural support may reduce or eliminate adverse effects such as stress risers. The structural support may provide a guide or surface for alignment of the fracture segments during reduction and healing.
[0126] The structural support may be configured in a contracted state and introduced through a hole in the shaft of the bone. The structural support may have sufficient flexibility in the contracted state to conform to curvature in an access pathway.
[0127] The structural support may be positioned inside the intramedullary cavity near a fracture site. The structural support may be expanded. When expanded, the structural support may be rigid. The structural support may be expanded sufficiently to fill the available cavity and/or displace low density material that may border the cavity. Expansion may vary along the surface of the structural support such that the expanded structural support may conform to irregular cavity shapes.
[0128] In some embodiments, an expansion state may be maintained with or without the structural support being in a stressed condition. Radial pressure against the cavity walls can be tailored along the length of the structural support. The structural support may provide strain relief in desired locations to promote healing.
[0129] The expansion of the structural support may be elastic. This may be achieved using a spring material that returns to its original configuration shape or pressure after release from the contracted state.
[0130] The expansion of the structural support may be plastic. The structural support may be deformed into a desired expanded configuration. The deformation may be achieved by a mechanism, such as a lever or reciprocating manipulators that change the length of the structural support. The lever or manipulators may shorten the distance between two portions of the structural member. Shortening the distance may cause radial expansion of a portion of the structural support.
[0131] Force for shortening the distance may be supplied by a central axis member that may transect the structural support. The resulting shape could be derived from a combination of the expansion described and the resistance of the cavity walls.
[0132] The deformation may be achieved by direct force, such as by a balloon.
[0133] The structural support may be expanded torsionally. The torsional expansion may be either elastic or plastic in nature. For example, the distal end of the structural support may be rotated relative to the proximal end. The structural support may then expand to fill the cavity.
[0134] Many different materials could be utilized to achieve the desire expansion and strength features described.
[0135] The structural support may include support members that form a cage or a portion of a cage. The support members may have one or more of many different configurations. The structural support may have any suitable number of support members. For example, the number of support members may be 1, 2, 3, 4, 5, 6, 7, 8, 10, 25, 50, 100 or more.
[0136] The support members may have any suitable cross-sectional shape. For example, the support members may have one or more of the following cross-sectional shapes: round, flat, rectangular, “I” beam, tubular, stranded, twisted and many others.
[0137] The structural support may have any suitable shape. For example, the structural support may be round, cylindrical, flat, rectangular, spiral, helical, wisk or egg beater like, egg like or oval, branching or free-ended.
[0138] The structural support may be constructed from unitary or multi-component assemblies. The structural support may be: machined, laser cut form a tube, etched from a sheet, assembled and joined strips, molded, deposited and or sintered.
[0139] The proximal end of the structural support may join and lock to the anchor substrate. The proximal end may also interface with the delivery instrument. The proximal end may have suitable features for delivery, actuation, locking and release. Such features may include, for example, one or more thread, socket, pin, snap, collet, cable mechanisms and other suitable mechanism.

Anchoring Substrate

[0140] The apparatus may include one or more anchoring substrates. An anchoring substrate may receive one or more anchors and hold them in a desired position with or without the joint assistance of the structural support and with or without cancellous bone. The anchoring substrate may be sized and shaped such that it may be engaged by an anchor that penetrates into the intramedullary space.
[0141] The anchoring substrate may be sized and shaped such that once the anchoring element penetrates into the intramedullary space, the anchoring substrate may engage the anchor. The anchoring substrate may provide to an anchor tension that is supplemental to tension caused by the engagement of the anchor and the anchoring substrate.
[0142] There are several methods by which the anchors and the anchoring substrate may engage.
[0143] Some of the methods are passive engagement methods. In passive engagement, anchoring substrate features may be appropriately sized to engage an anchor. For example, the anchor and anchoring substrate may be configured such that they engage in a manner analogous to a screw and hole. A laser cut structure could take any shape necessary to achieve appropriate anchor engagement and retention. The receiving cavities (“cells”) could be round, square, slotted, triangle, or any shape that facilitated engagement. The geometry of the cells may be that of a shortening design. The cells may form a matrix, a “fabric,” or a “cloth.” The anchoring substrate may include a single layer or multiple layers.
[0144] Matrix characteristics may be varied along an axis of the anchoring substrate to provide anchoring characteristics along the axis. For example, cell geometry may be varied to provide engagement with different types of anchors. Anchoring substrate thickness may be varied to provide different degrees of anchor retention strength and forces.
[0145] There are several approaches to active engagement. One such approach is cell size reduction. The anchoring substrate may be deformed such that the size of cells is reduced. The cell size reduction may cause tightening (or locking) of the cell onto the anchor.
[0146] Another such approach involves relative displacement between first and second anchoring substrates. The relative displacement effectively reduces cell size when corresponding cells are offset from each other. The relative displacement may be axial, rotational, radial, etc. . . . The relative displacement may trap an anchor between the two displaced anchoring substrates and effectively lock or hold the anchor. Cells of selected shapes, either similar or different, in the first and second anchoring substrates may be moved in a cooperative manner to trap or engage the anchor.
[0147] Another such approach involves twisting the anchoring substrate. This action may be similar to stretching and locking the anchor in the medium of the substrate. Other approaches include wrapping, plicating and bunching the anchoring substrate. A plicated or bunched configuration may exert force by having several layers of material binding on the anchor at one time, effectively wire tying the anchor.
[0148] The arrangement of different portions of the anchoring substrate may be selected to facilitate engagement with an anchor. Portions of the anchoring substrate may extend radially away from a central or longitudinal axis of the apparatus or the anchoring substrate. Portions of the anchoring substrate may be supported in a perpendicular orientation with respect to the axis.
[0149] After the anchoring substrate is engaged with an anchor, the anchoring substrate may apply tension to the anchor. The tension may urge the anchor to move relative to the structural element. This can be accomplished by moving the anchoring substrate in an axial direction relative to the structural member. If the anchoring substrate is moved proximally relative to the structural support, tension would be applied to the anchors and their corresponding fracture segments.
[0150] The tension may be achieved by reducing the diameter of the anchoring substrate. This can be accomplished though lengthening and therefore reducing the anchoring substrate diameter. The tension may be applied by wrapping, folding, twisting, rotating or radially pulling in the anchoring substrate. The plicated or bunched configuration mentioned above may be used for this approach.
[0151] In some embodiments, the anchoring substrate may be internal to the structural support. In some embodiments, the anchoring substrate may be external to the structural support. Some embodiments may include one or more anchoring substrates that are internal to the structural support and one or more anchoring substrates that are external to the structural support. In some embodiments, the anchoring substrate may be attached to the structural support.
[0152] In some embodiments, the anchoring substrate may cooperate mechanically with the structural support. The anchor substrate may provide structural integrity to the device. For example, the matrix may include interlockable features. The interlocking features may become interlocked during or after the anchoring substrate is expanded.
[0153] In some embodiments, the anchoring substrate may be mechanically independent of the structural support. This may allow for relative movement between the anchoring substrate and the structural support.
[0154] The anchoring substrate may be expandable. The anchoring substrate may expand simultaneously with the structural support. The anchoring substrate may be expanded by the structural support. The anchoring substrate may be expanded by a delivery device such as a balloon. The substrate may be self-expanding. Self-expanding embodiments may include spring like elements. Self-expanding embodiments may include elements that include shape memory materials, such as shape memory alloys. In some embodiments, the anchoring substrate may be non-expanding. In some embodiments, the anchoring substrate may be expandable by mechanical actuation.
[0155] The anchoring substrate may be constructed in many different forms and of many different materials. The forms may include, for example, braid, mesh, weave, strand, laser cut members, deposited members or other filament construction. The anchoring substrate cells may be round elements, square element, rectangular elements, or profiled, or a combination of cell types. The anchor substrate cells may be designed to mimic bone and act as a growth or graft scaffold.
[0156] The anchoring substrate may be made form a unitary element such as an extruded tube or flat sheet with a pattern cut into it that would facilitate engagement. Examples include a laser-cut tube, a stamped or etched sheet, and other suitable approaches.
[0157] The anchoring substrate may be made of many materials including but not limited to; Nitinol, Titanium, steel alloys, polymers, porous materials, sponge like materials, sintered metal, etched materials, deposited material, extruded material and molded materials.

Anchors

[0158] Anchors may facilitate the attachment of bone segments to the anchoring substrate. The anchors may mate, couple, engage, lock and otherwise interact with the anchoring substrate. Some of the anchors may be configured to engage the bone. Some of the anchors may be configured to not engage the bone.
[0159] An anchor may have an elongated element. The elongated element may include one or catch features that are configured to engage the anchoring substrate. The engagement may be occur substantially immediately after penetration of the anchoring substrate by the anchor. The engagement may occur only after a predetermined length of the elongated member has passed into the anchoring substrate. Some anchors may lock to the anchoring substrate. Some anchors may not lock to the anchoring substrate
[0160] Catch features may be self-actuating. Catch features may be user actuated.
[0161] Anchors may have any suitable length. Anchors of different lengths may be used in conjunction with the apparatus. The anchors can be configured to enter and engage the anchoring substrate with an end portion of the anchor. Those anchors, after they are locked, may terminate inside the anchoring substrate. Some anchors may be configured to pass through the anchoring substrate and engage bone on an opposite side of the anchoring substrate. Some anchors may be configured to not engage bone on either side of the anchoring substrate. Example anchors include: screws, helical elements, T bar, barbed features, anchors cut from a tube, with tabbed features.
[0162] In some embodiments, anchors may be used in conjunction with buttress elements such as plates, washers, spacers and the like.
[0163] A proximal anchor may be inserted to anchor a proximal portion of the anchoring substrate to the bone. In some embodiments, the proximal anchor may be engaged to preserve tension in the anchoring substrate. In some embodiments, the proximal anchor may be configured to adjust the tension.

Central Axis Member

[0164] In embodiments that include a central axis member, the central axis member may be used to position the apparatus, actuate one or more changes (e.g., of expansion state or stress state) of the apparatus, move one portion of the apparatus relative to another portion of the apparatus and provide mechanical support (e.g., rigidity) to the apparatus.
[0165] In some embodiments, the apparatus may have a distal end and a proximal end. The support structure may have a distal end and a proximal end. The anchoring substrate may have a distal end and a proximal end. The central axis member may have a distal end and a proximal end. In some embodiments, the central axis member may extend proximally beyond the proximal ends of the structural support and the anchoring member. In those embodiments, an intermediate portion of the central axis member may generally align with the proximal ends of the structural support and the anchoring substrate.
[0166] The central axis member may be used to maintain rigidity of the structural support and/or the anchoring substrate. In those embodiments, the distal end of the central axis member may be longitudinally fixed to the distal end of the structural support and/or the anchoring substrate. The proximal end or intermediate portion of the central axis member may be longitudinally fixed to the proximal end of the structural support and/or the anchoring substrate.
[0167] The central axis member may be used to adjust the length of the structural support and/or the anchoring substrate. In those embodiments, the distal end of the central axis member may be fixed to the distal end of the structural support and/or anchoring substrate. The proximal ends of the structural support and/or anchoring substrate may be longitudinally movable (whether linearly, rotationally or otherwise) with respect to the central axis member. As such, the central axis member may be used to expand the structural support or the anchoring substrate. The central axis member may be used to lock the apparatus in an expanded configuration. The central member may be locked in place by other elements of the apparatus.
[0168] In some embodiments, the central axis member may be used to place a lower or upper limit on the longitudinal separation between distal and proximal ends of the support structure and/or anchoring substrate. This may be accomplished by providing detents at selected locations along the central axis member.
[0169] In some embodiments, the central axis member may be used to linearly displace the structural support relative to the anchoring substrate or the anchoring substrate relative to the support structure. The central axis member may be used to linearly displace one anchoring substrate relative to another anchoring substrate. In such embodiments, the central axis member may be longitudinally fixed to whichever of the structural support and the anchoring substrate that is to be moved relative to another.
[0170] The central axis member may be used to mechanically load the structural support and/or the anchoring substrate. The load may be in tension, compression or rotation. The load may be applied by suitable engaging the central axis member with a portion of the structural support and/or anchoring substrate. The central axis member may then be loaded, for example, at its proximal end. The central axis member may then transfer the load through the engagement with the structural support and/or anchoring structure.
[0171] Where the central axis member is longitudinally fixed to the structural support and/or anchoring substrate, it may remain free to rotate. Where the central axis member is not longitudinally fixed, the apparatus may include suitable bushings, bearings, frictional surfaces and the like to permit suitable linear displacement and/or rotation between the central axis member and the structural support and/or anchoring substrate.
[0172] For example, the central axis member may be longitudinally fixed to the distal end of the structural support and rotationally fixed to the proximal end of the anchoring substrate. The distal end of the anchoring substrate may or may not be rotationally fixed to the distal end of the support structure. The central axis may thus be used in different configurations to deform (e.g., wrap, fold, twist, etc.) the anchoring substrate. Similar configurations may be used to deform the structural support.
[0173] In some embodiments, the central axis member may include or serve as an anchoring substrate. The central axis member may be removable so that it may be removed from the apparatus after its desired effect is achieved.
[0174] The central member may be flexible or rigid. The central member may be integral with one or both of the structural support and the anchoring substrate. The central axis member may include one or more cables, coils, thread, braids, extrusions, beading, rods, bundles, strands, meshes, nested elements and the like.

Apparatus Removal

[0175] The apparatus may be removable from the bone. Approaches for removal may include collapsing the apparatus.
[0176] In some instances, tissue may grow into interstices of the apparatus. Energy (e.g., vibrations, ultrasonic energy, heat and the like) may be coupled into the apparatus to release the tissue. When heat energy is used, the heat may be generated from energy in any suitable form, such as radio frequency, microwave, induction, electrical resistance, and others.
[0177] The apparatus and methods may include removal instruments such as a hollow drill, a coring drill and the like. The apparatus may fit inside one or more of such instruments.

Bone Ingrowth

[0178] One or more surfaces of the apparatus may be coated with agents that promote bone ingrowth. The agents may include calcium phosphate, heat treated hydroxylapatite, Basic fibroblast growth factor (bFGF)-coated hydroxyapatite, hydroxyapatite/tricalcium phosphate (HA/TCP), and other suitable agents, including one or more of those listed in Table 1.
[0179] One or more surfaces of the apparatus may be coated with agents that inhibit or prohibit bone ingrowth. Such surfaces may include impermeable and other materials such as one or more of those listed in Table 1.

Drug Delivery

[0180] One or more surfaces of the apparatus may be coated with agents that may elute therapeutic substances such as drugs.

Complications

[0181] The apparatus and methods may include means to address complications that may be associated with bone implants. One such complication is infection. The apparatus and methods may include features that counteract infection. For example, such a feature may include a coating. The coating may include antibiotics such as tobramycin or other effective antimicrobials. Another such feature may be the delivery of heat to raise the apparatus temperature sufficiently high to kill bacteria and other undesirable tissues on or near the implant.

Installation

[0182] The following is one illustrative method of installation of the apparatus in a bone that has a fracture. The procedure may be completed either in an inpatient or an outpatient setting.
[0183] 1. Provisionally reduce the fracture using standard techniques
[0184] 2. Access the intramedullary cavity in a location that causes minimal tissue damage to the patient and sufficient access for the physician; proximal or distal.
[0185] 3. Introduce a delivery catheter into the bone near the area of the fracture. Position can be confirmed on fluoroscopy.
[0186] 4. Deploy the structural support. A positioning aid, which may be a central axis member, may be used. External manipulation may be applied.
[0187] 5. Reposition the fractured bone into its ideal healing location. The positioning aid may then be locked into the wall of the intramedullary cavity by deploying the anchoring mechanism.
[0188] 6. Deploy an anchor tensioning element (such as an anchoring substrate) into the space inside the structural support and near the location of the fracture.
[0189] 7. Deploy anchors in the fracture fragments, either externally or internally, depending on accessibility. The anchors are driven through both the fragments and the anchoring substrate.
[0190] 8. Confirm location of the fragments via x-ray, fluoro, or direct visualization. Apply tension as needed to position the fracture in the desired position with adequate pressure on the fragment surfaces to stabilize the fracture for healing.
[0191] 9. Lock the apparatus in place.
[0192] 10. Disengage delivery instruments from the apparatus. Remove the delivery instruments from the patient, and close patient.
[0193] Numerous other steps may be involved and many different sequences of steps may be practiced without departing from the principles of the invention.

Materials

[0194] The apparatus and portions thereof may include any suitable materials. Table 1 lists illustrative materials that may be included in the apparatus and portions thereof.
[0195] 
[00001] [TABLE-US-00001]
  TABLE 1
 
  Materials
  Category   Type   Material
 
  Metals   Nickel titanium alloys   Nitinol
    Stainless steel alloys   304
      316L
      BioDur ® 108 Alloy
      Pyromet Alloy ® CTX-909
      Pyromet ® Alloy CTX-3
      Pyromet ® Alloy 31
      Pyromet ® Alloy CTX-1
      21Cr—6Ni—9Mn Stainless
      21Cr—6Ni—9Mn Stainless
      Pyromet Alloy 350
      18Cr—2Ni—12Mn Stainless
      Custom 630 (17Cr—4Ni)
      Stainless
      Custom 465 ® Stainless
      Custom 455 ® Stainless Custom
      450 ® Stainless
      Carpenter 13-8 Stainless
      Type 440C Stainless
    Cobalt chromium alloys   MP35N
      Elgiloy
      L605
      Biodur ® Carpenter CCM alloy
    Titanium and titanium   Ti—6Al—4V/ELI
    alloys   Ti—6Al—7Nb
      Ti—15Mo
    Tantalum
    Tungsten and tungsten
    alloys
    Pure Platinum
    Platinum- Iridium
    alloys
    Platinum -Nickel
    alloys
    Niobium
    Iridium
    Conichrome
    Gold and Gold alloys
  Absorbable     Pure Iron
  metals     magnesium alloys
  Polymers     Polyetheretherketone (PEEK)
      polycarbonate
      polyolefin's
      polyethylene's
      polyether block amides
      (PEBAX)
      nylon 6
      6-6
      12
      Polypropylene
      polyesters
      polyurethanes
      polytetrafluoroethylene (PTFE)
      Poly(phenylene sulfide) (PPS)
      poly(butylene terephthalate)
      PBT
      polysulfone
      polyamide
      polyimide
      poly(p-phenylene oxide) PPO
      acrylonitrile butadiene
      styrene (ABS)
      Polystyrene
      Poly(methyl methacrylate)
      (PMMA)
      Polyoxymethylene (POM)
      Ethylene vinyl acetate
      Styrene acrylonitrile resin
      Polybutylene
  Membrane     Silicone
  materials     Polyether block amides
      (PEBAX)
      Polyurethanes
      Silicone polyurethane
      copolymers
      Nylon
      Polyethylene terephthalate
      (PET)
      Goretex ePTFE
      Kevlar
      Spectra
      Dyneena
      Polyvinyl chrloride (PVC)
  Absorbable     Poly(glycolic acid) (PGA)
  polymers     Polylactide (PLA),
      Poly(ε-caprolactone),
      Poly(dioxanone)
      Poly(lactide-co-glycolide)
  Radiopaque     Barium sulfate
  materials     Bismuth subcarbonate
  Biomaterials   Collagen   Bovine, porcine, ovine, amnion
      membrane
  Bone growth     Demineralized bone matrix
  factors     Bone morphogenic proteins
      (BMP)
      Calcium phosphate
      Heat-treated
      hydroxylapapatite
      Basic fibroblast growth factor
      (bFGF)-coated hydroxyapaptite
      Hydroxyapaptite/tricalcium
      phosphate (HA/TCP
  Anti-
  microbial
  Coatings
 
[0196] The apparatus may be provided as a kit that may include one or more of a structural support, an anchoring substrate, a central axis member, an anchor, a delivery instrument and associated items.
[0197] Apparatus and methods in accordance with the invention will now 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.
[0198] 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 and described herein. Some embodiments may omit steps shown and described in connection with the illustrative methods. Some embodiments may include steps that are not shown and described in connection with the illustrative methods.
[0199] Illustrative embodiments will now be described with reference to the accompanying drawings, which form a part hereof.
[0200] 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.
[0201] FIG. 1 shows illustrative device 100 implanted in bone B, which is illustrated as a radius. 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. Bone segments Ph and Pa include articular surface AS. 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 H.
[0202] It will be appreciated that bone portions PB, Ph and Pa define an illustrative fracture in bone B. Device 100 may be used to treat fractures that have a greater or lesser number of bone portions. The bone portions may have different shapes, orientations and sizes from those shown in FIG. 1. It will be appreciated also that the fracture shown in FIG. 1 is illustrated as a fracture near the end of a long bone, but device 100 may be used to treat fractures in other portions of long bones, such as the midshaft, and in bones that may be identified as being other than long bones, e.g., vertebrae.
[0203] Device 100 is elongated along its longitudinal axis LD (in which D indicates device). Device 100 is in intramedullary space IS of bone B. Distal end 102 of device 100 is in epiphyseal region E of bone B. Proximal end 104 is in or adjacent diaphyseal region D of bone B. Portions of device 100 that are between distal end 102 and proximal end 104 are in metaphyseal region M of bone B.
[0204] Device 100 may include structural cage 105. Structural cage 105 may include support members 106. Support members 106 may extend from cage base 108 to distal hub 110. (The direction extending from cage base 108 will be referred to as the “distal direction.” The opposite direction will be referred to as the “proximal direction.” “Distal,” relative to “proximal,” generally means the leading end of apparatus that is inserted, or is to be inserted, in the body.) The distance along axis LD between cage base 108 and distal hub 110 may be adjusted to change the shape of support members 106.
[0205] When cage base 108 is maximally spaced apart from distal hub 110, structural cage 105 is in a compressed state. When cage base 108 and distal hub 110 are pushed or drawn together, structural members 106 are deflected radially outward along radial direction RD (in which “D” indicates device). In this way, structural cage 105 may expand. Device 100 is shown in an expanded state. In some embodiments, structural members 106 and anchor substrate 124 may self-expand radially. This may draw base 108 and distal hub 110 together longitudinally.
[0206] Structural cage 105 may be used to provide support to bone portions PB, Pa and Ph. The support may include aligning and stabilizing bone segments PB, Pa and Ph during reduction and/or healing. The support may be subchondral support. Structural cage 105 may be used to provide load resistance to bone B during healing.
[0207] Device 100 may include anchoring substrate 112. Substrate 112 may be engaged by anchors such as 114 and 116. Anchor 114 fastens bone segment Ph to substrate 112. Anchor 116 fastens bone segment Pa to substrate 112. The anchors may engage substrate 112 in a wide range of positions. The anchors may engage substrate 112 from a wide range of angles. Each of the anchors may apply a force to its respective bone portion. The force may be oriented to appropriately position the bone portions for healing. The force may be directed at least in part toward axis LD. The force may be considered an inward force (at least partially in direction −RD). Structural cage 105 may apply to the bone portions a force that is directed at least in part away from axis LD. The force from structural cage 105 may be considered an outward force (at least partially in direction RD).
[0208] Anchors 114 and 116 are illustrated as threaded screws, but any suitable anchors may be used.
[0209] The anchors, anchoring substrate and support structural cage may thus be used in concert to select for each bone portion one or more of a desired position, orientation and force. One or both of the position and orientation may be selected by appropriate selection of anchor size, anchor position, anchor tension, structural cage size, and support member configuration and position. Because the position and orientation may be selected, the bone portions may be appropriately aligned relative to each other.
[0210] Device 100 may include stem 128. Stem 128 may extend in the proximal direction from cage base 108. Stem 128 may include stem anchoring substrate 118 and proximal base 120. Stem anchoring substrate 118 may support proximal base 120. Anchor 122 may fasten stem 128 to bone B portion PB. Anchor 122 may be engaged such that it applies longitudinal and/or rotational forces to device 100. Anchor 122 may be engaged such that it applies a radial force to device 100. The radial force may induce or counteract bending of device 100 along axis LD. Anchor 122 may apply a resistive longitudinal force to device 100. The resistive longitudinal force may resist forces applied to device 100 by distal anchors 114 and 116.
[0211] Proximal base 120 may support device retention feature 122. Device retention member 126 may be used to engage device 100 for insertion and manipulation. A device manipulator (not shown) may be used in conjunction with device retention member 126 to draw device 100 in the proximal direction.
[0212] Device may include illustrative central member hub 130. Central member hub 130 may be used to recapture and remove device 100 after deployment.
[0213] Drawing device 100 in the proximal direction may adjust forces (tensile, compressive or both) between bone portions Pa, Ph and PB. Drawing device 100 in the proximal direction may adjust the orientation and position of bone portions Pa with respect to PB. In some embodiments, anchor 122 may be used to retain the compressive forces after device 100 is drawn in the proximal direction.
[0214] Device 100 may include central axis member 124. Central axis member 124 may extend from distal hub 110, through cage base 108 and through proximal base 120 into intramedullary space IS of bone B. Central axis member 124 may be used to effect expansion of structural cage 105. Some embodiments may not include central axis member 124. (In some embodiments, anchoring substrate 112 may be drawn proximally relative to structural cage 105 to adjust the tension while maintaining the position and support of the bone segments.)
[0215] In some embodiments, central axis member 124 may be used to expand structural cage 105 by applying tension between hub 100 and cage base 108 and/or 120. In some embodiments, this may be done by applying simultaneously a proximally directed force to central axis member 124 and a distally directed force to cage base 108. In some embodiments, central axis member may be rotatably connected to hub 110 and threaded through cage base 108. In those embodiments, structural cage 105 may be expanded by rotating central axis member 124. In some embodiments, structural cage 105 may be self-expanding.
[0216] The final expanded shape may be designed into the structure of structural cage 105. The final expanded shape may be limited by the space available in the cavity. The expansion may be elastic and may be based on a spring material that returns to a predetermined shape.
[0217] Device 100 in its compressed state may be delivered into the body through a small access incision along the mid shaft section bone (D, in FIG. 1) in an area where soft tissue disruption can be minimized.
[0218] FIG. 1A shows device 100 in isometric view. Structural cage 105 includes support members 106. Support members 106 may expand or contract along direction RD based on relative positioning of cage base 108 and hub 110 along device axis LD. Support cage 105 may be contracted for introduction into intramedullary space IS.
[0219] Support cage 105 is illustrated as having six support members 106. It will be appreciated that any suitable numbers of support members may be used. for example, support cage 105 may have a number of support members 106 in the range of 2-40 or more than 40.
[0220] Support members 106 are illustrated as having a rectangular cross-sectional shape. It will be appreciated that support members 106 may have any suitable cross-sectional shape. For example, the cross-sectional shape may be round, square, braided, stranded or profiled. Support cage 105 may include support members that have different cross-sectional shapes, dimensions or material properties. When support members have different shapes, dimensions or material properties, support cage 105 may undergo non-radial deformation. Such deformation may be helpful for conforming device 100 to the inside of bone B (including bone segments Pa, Ph and PB).
[0221] Support members 106 are illustrated as being joined at cage base 108 and hub 110. The ends of the members are shown joined at both ends. In some embodiments, support members 106 may have one or more free or partially free ends.
[0222] Support members 106 may be cut of a single tube or could be made independently and then joined.
[0223] Anchoring substrate 112 is present inside structural cage 105. Anchoring substrate 112 may have a collapsed state and an expanded state. The collapsed state may be used for delivery. The expanded state may be used for deployment and fracture repair.
[0224] In some embodiments, anchoring substrate 112 may include a laser-cut structure. Anchoring substrate 112 may be constructed so as to engage with an anchor such as 114 (shown in FIG. 1) and hold the anchor under a mechanical load. In some embodiments, anchoring substrate 112 may be affixed to support cage 105. Anchoring substrate 112 may be affixed to one or more of hub 110, one or more portions of support members 106, central axis member 124, cage base 108 and proximal base 120.
[0225] In some embodiments, anchoring substrate 112 may not be affixed to device 100 (although it may be retained by support cage 105). Such lack of attachment may facilitate adjustment of the tension and loading of bone segments.
[0226] FIG. 1B is a cross-sectional view taken along lines 1B-1B (shown in FIG. 1A). FIG. 1B shows central axis member 124 running from hub 110 (not shown) through anchoring substrate base 132 (which is concentrically within cage base 108), stem 128, proximal base 120 and device retention member 126.
[0227] Central member hub 130 protrudes proximally from device retention member 126. Central member hub 130 may be configured to be engaged to adjust or control tension and or rotation of central member 124. Manipulation of central member hub 130 may facilitate delivery and expansion of structural cage 105, and or anchor substrate 112. Central member hub 130 may maintain tension between distal and proximal ends of structural cage 105 or anchoring substrate 112.
[0228] Device retention member 126 may be used to in connection with delivery, manipulation and or removal of device 100.
[0229] Stop 134 on central axis member 124 may be drawn in proximal direction DP by pulling central member hub 130 in direction DP relative to stem 128. In some embodiments, this may be accomplished by pushing device retention member 126 distally (−DP) while pulling central member hub 130 proximally. The pushing and pulling may be accomplished using apparatus and methods shown and described herein or known grasping device instruments.
[0230] Stop 134 will urge anchoring substrate base 108 in direction DP. Anchoring substrate base 108 will then draw anchoring substrate 112 in direction DP. Motion of anchoring substrate 112 in direction DP will apply force to anchors 114 and 116. The force may have a distal component and a radially inward (−RD) component. The force may thus compress bone segments Pa and Ph against bone segment PB (shown in FIG. 1).
[0231] Stop 134 may transfer longitudinal force from device retention member 126 in a proximal direction to anchor substrate 112 through the coupling mechanism between device retention member 126, proximal base 120 and central member hub 130. Alternatively central axis member 124 may be coupled mechanically to cage base 108 by a ratchet, screw or other suitable mechanism.
[0232] FIG. 1C shows a view taken along lines 1C-1C (shown in FIG. 1A). FIG. 1C shows expanded support cage 105 (including hub 110) and expanded anchoring substrate 112. Locking anchor 122 is also shown.
[0233] One or more of the surfaces or elements of device 100 may include a coating. The coating may include an agent. The agent may provide a bone growth promotion agent, a bone growth inhibition or prohibition agent, a drug eluting agent or any other suitable agent.
[0234] FIG. 2 shows illustrative skeleton S. Skeleton S includes illustrative bones Si in which device 100 (shown in FIG. 1) may be used as shown and described in connection with bone B (shown in FIG. 1). Table 2 includes a partial list of bones Si.
[0235] 
[00002] [TABLE-US-00002]
  TABLE 2
 
Bones Si.
      Reference
      numeral in
    Bone   FIG. 2
   
    Distal RadiusS0
    HumerusS1
    Proximal Radius and Ulna (Elbow)S2
    MetacarpalsS3
    ClavicleS4
    RibsS5
    VertebraeS6
    UlnaS7
    HipS8
    FemurS9
    TibiaS10
    FibulaS11
    MetatarsalsS12
   
[0236] FIG. 3 schematically shows anatomy of bone B (shown in FIG. 1). Anatomical features of bone B are listed in Table 3. Apparatus and methods in accordance with the principles of the invention may involve one or more of the anatomical features shown in Table 3. Features of bone B may be described in reference to bone axis LB (in which B indicates bone) and radius RB (in which B indicates bone).
[0237] 
[00003] [TABLE-US-00003]
  TABLE 3
 
  Anatomical features of some of the bone types that
  may be treated by the apparatus and methods.
      Reference
      numeral in
    Anatomical feature   FIG. 3
   
    Articular surfaceB0
    Cancellous, spongy or trabecular boneB1
    Medullary cavityB2
    Cortical or dense boneB3
    PeriosteumB4
    Proximal articular surfaceB5
    Diaphysis or midshaftB6
    Metaphysis or end regionB7
    EpiphysisB8
    Articular surfaceB9
   
[0238] The terms “end-bone” and “end-bone fracture” may be used to refer to fractures that occur in the epiphyseal or metaphyseal region of long bones. Such fractures include peri-articular and intra-articular fractures.
[0239] FIG. 4 shows portion 400 of an illustrative surgical environment in which a fracture in bone B may be diagnosed and treated. Patient P may be sedated appropriately. A limb nerve block may be administered. A pressure cuff may be used to maintain limb Q in a relatively blood-free state. Limb Q may be supported by procedure table 402 and any other appropriate supports to manage the position of bone B during surgery. Environment 400 may include imaging system 404.
[0240] FIG. 5 shows illustrative therapeutic scenario 500. In scenario 500, manual traction techniques are applied to reestablish anatomic reduction in fracture Fp in bone B.
[0241] Provisional or temporary reduction is often undertaken in fracture repair to restore bone segments to their normal positions before they are anchored.
[0242] When the number of bone segments is small and/or the dislocation of the bone segments is modest, closed reduction techniques may be employed. Closed reduction does not include incisions and utilizes manual traction by one or more physicians. The physicians will utilize different tension, compression, and bending motions to reestablishing normal bone segment positioning. A physician or assistant may maintain the normal bone segment positions during an implant procedure.
[0243] For more displaced fracture patterns, a limited open reduction can be utilized. K-Wires, external probes, and special clamps can be employed for the provisional reduction. Small incisions can be made allowing the probes and clamps to aid in repositioning the fracture segments. Once the bone segments are in position k-wires can be utilized to maintain the reduction. K-Wires are approximately 1-2 mm in diameter metallic wires that can be driven across fracture lines to provide temporary support. The k-wires may be positioned and then removed strategically to facilitate the procedure in a way that reduces interference with bone cavity preparation or implant deployment.
[0244] FIG. 6 shows illustrative sheath 600. Hollow sheath 600 is shown entering intramedullary space IS of bone B. Sheath 600 may include lumen 610. Lumen 610 may provide access to intramedullary space IS. Sheath 600 enters intramedullary space IS at position 602. Position 602 may be in diaphyseal section D of bone B. Position 602 may be selected to minimize soft tissue damage. Near position 602, a small incision may be made in the soft tissue (not shown). The tissue may be displaced to reveal bone surface BS.
[0245] A standard orthopaedic drill instrument may be used to create access hole 604 in bone B. Axis hole 604 may be drilled along axis Lh. Axis Lh may form an angle A with bone axis LB. Angle A may be an acute angle.
[0246] Hole 604 may be similar to commonly drilled bone access holes. Hole 604 may be sufficiently small that hole 604 does not cause stress risers at position 602. Distal end 606 of sheath 600 may be advanced, through intramedullary canal IC, into metaphyseal region M of bone B. Proximal end 608 of sheath 600 may be positioned in hole 604. Distal end 606 may be disposed in any portion of intramedullary space IS, such as in the end-bone.
[0247] Sheath 600 may be a thin-walled flexible cannula. Sheath 600 may be similar to the cannulas that are commonly used in minimally invasive or percutaneous interventional procedures elsewhere in the body. Sheath 600 may be made of rigid metal that is shaped to promote access to intramedullary space IS.
[0248] FIG. 7 shows illustrative intramedullary space reamer 700. Reamer 700 may be expandable and contractible. Reamer 700 may in a contracted state be inserted in proximal end 608 of sheath 600 (shown in FIG. 6). Reamer shaft 702 may be used to advance reamer 700 through lumen 610 into metaphyseal region M of bone B. Reamer 700 may have suitable features at or about surface 704 for removing undesirable tissue, such as cancellous bone, from the end-bone. Reamer shaft 702 may rotate reamer surface 704 about, and translate it along, bone axis L as appropriate to prepare the end-bone for further treatment.
[0249] In some embodiments, the use of reamer 700 may be consistent with procedures that are used in the implantation of intramedullary nails. Such procedures include the application of one or more of ultrasonic energy, vibration, RF energy, pressure, rotation, water jetting, suction and other suitable mechanisms to remove the undesirable tissue. In some embodiments, reamer 700 may have one or more of the following features: expansion, fixed size (non-expanding), uni-directional reaming, multi-directional reaming, rigid reamer shaft 702, flexible reamer shaft 702 and steerability.
[0250] FIG. 8 shows a stage in the delivery of device 100 to end-bone of bone B. In FIG. 8, device delivery apparatus 800 is engaged with device retention element 126 at the proximal end of device 100. Shaft 802 may control positioning and rotation of device delivery apparatus 800. Delivery apparatus 800 may include a keyed grasper for engagement and disengagement of portions of device 100 (shown in FIG. 1). Device 100 is in a compressed state. Device 100 is positioned within lumen 610 of sheath 600. Distal hub 110 of device 100 is in epiphyseal region E of bone B. Support members 106 and stem 128 are also shown within lumen 610.
[0251] FIG. 9 shows a subsequent step in the delivery of device 100 to the end-bone of bone B. In FIG. 9, device delivery apparatus 800 has moved device 100 distally out of sheath 600. Structural cage 105 has been expanded in the end-bone. In the example illustrated, the end-bone spans from the bone segments to midshaft D of bone B intramedullary space IS.
[0252] FIG. 9 also shows proximal delivery apparatus controller 900. Controller 900 may include handle 902, trigger mechanism 904 and set screw 906. Handle 902 may be used to apply, via shaft 802, the forces that are necessary to position and expand device 100. Trigger mechanism 904 may be used to engage or disengage device retention member 126.
[0253] FIG. 10 shows the fastening of bone segment Pa to anchoring substrate 112. A small incision may be made in skin K in an optimal location. Then, a small pilot hole may be made in the bone segment Pa. Provisional reduction may be maintained by assistant's hand 1002, tong/clamp type instruments, k-wires or other known methods. Support 1004 may be provided to position bone segments Pa, Ph and PB for the insertion of anchor 116. Then, instrument 1000 may be used to drive anchor 116 through bone segment Pa. Instrument 1000 may be a screwdriver or other suitable instrument.
[0254] FIG. 11 shows anchor 114 fastening bone segment Ph to anchoring substrate 112. Device 100 may be stabilized in bone B using device delivery apparatus 800.
[0255] FIG. 12 shows tensioning device 100 in intramedullary space IS of bone B. Anchors 114 and 116 have been completely or almost completely driven into bone segments Ph and Pa, respectively. Anchors 114 and 116 are secured inside bone B by anchoring substrate 112. The inward forces applied by anchors 114 and 116, in concert with anchoring substrate 112, and the outward forces applied by support members 106 of structural cage 105, have brought bone segments Ph and Pa into alignment along fracture Fa and have closed fracture Fa. The torque (applied to the anchors), angle and positioning of anchors 114 and 116 may be selected to provide a desired contact force between bone segments Ph and Pa along fracture Fa. The anchors may lock to anchor substrate 112 to prevent unintentional removal.
[0256] Fracture Fh remains open by separation amount Δf, which separates Pa and Ph from PB, the main segment of bone B. Intersegment compression of bone segments Pa, Ph and PB may be provided using one or more of device 100, device delivery apparatus 800 and delivery apparatus controller 900. The compression may help reduce or eliminate Δf. The compression may promote healing. The compression may provide stability to the bone segments in rotation and bending.
[0257] In some embodiments, the compression may be provided by drawing device 100 in proximal direction Dp, substantially. Length T of device 100 may be fixed, at least temporarily. For example, length T may be held fixed using a mechanical relationship of central axis member 124 to cage base 108 and hub 110. Device 100 may then be drawn in direction Dp by device delivery apparatus 800. Device delivery apparatus 800 may be drawn in direction Dp by shaft 802. Shaft 802 may be drawn through lumen 610 using delivery apparatus controller 900.
[0258] Device 900 may include a mechanism that may be activated by a trigger or lever such as 904 or 906. Shaft 802 may be drawn by drawing delivery apparatus controller 900 in direction Dh along axis Lh. Distal end 606 of sheath 600, to the extent that it remains in intramedullary space IS, will travel generally along direction Dp and draw device 100 in that direction via device delivery apparatus 800.
[0259] In some embodiments, length T may be allowed to extend when device 100 is drawn in direction Dp. Hub 110 may be substantially retained in position relative to bone segment Pa. Cage base 108 may be allowed to be displaced in direction Dp. This may reduce radius RD of structural cage 105. When the radius of structural cage 105 is reduced, radially outward forces on bone may be reduced, canceled or reversed.
[0260] As the length of device 100 is increased while its radius decreases, device 100 may collapse partially or completely to its delivered state. Depending on the diameter of intramedullary space IS of bone, B such contraction may be desirable to obtain proper placement of the bone segments. After proper bone segment position is obtained, the radial diameter can be adjusted to achieve the desired shape and radial force. This condition can then be maintained by locking central axis member 124 at distal and proximal ends of device 100.
[0261] In some embodiments, a proximal portion of anchoring substrate 112 may be drawn in direction Dp. This may draw anchors such as 114 and 116 in direction Dp and direction −RB. Anchoring substrate 112 may be drawn in direction Dp with a force that is greater, lesser or equal to that by which structural cage 105 is drawn in direction Dp.
[0262] In some embodiments, a physician may assess and, if appropriate, adjust one or more of segments Pa, Ph and PB to achieve a desired alignment. The assessment may be performed using fluoroscopic imaging, for exam