Fatigue-resistant Gastric Banding Device

  *US08382780B2*
  US008382780B2                                 
(12)United States Patent(10)Patent No.: US 8,382,780 B2
 Birk et al. (45) Date of Patent:Feb.  26, 2013

(54)Fatigue-resistant gastric banding device 
    
(75)Inventor: Janel Birk,  Oxnard (CA) 
(73)Assignee:Allergan, Inc.,  Irvine, CA (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 293 days. 
(21)Appl. No.: 12/851,437 
(22)Filed: Aug.  5, 2010 
(65)Prior Publication Data 
 US 2010/0324359 A1 Dec.  23, 2010 
 Related U.S. Patent Documents 
(63) .
Continuation of application No. 10/492,784, filed on Apr.  18, 2005, now Pat. No. 7,811,298 .
 
(60)Provisional application No. 60/407,219, filed on Aug.  28, 2002.
 
(51)Int. Cl. A61B 017/08 (20060101); A61F 002/02 (20060101); A61F 002/00 (20060101)
(52)U.S. Cl. 606/157; 600/31; 600/37
(58)Field of Search  606/151, 201-203, 157; 600/37, 31

 
(56)References Cited
 
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 2005//0038484  A1  2/2005    Knudson et al.     
 2005//0038498  A1  2/2005    Dubrow et al.     
 2005//0055039  A1  3/2005    Burnett et al.     
 2005//0070934  A1  3/2005    Tanaka et al.     
 2005//0070937  A1  3/2005    Jambor et al.     
 2005//0100779  A1  5/2005    Gertner     
 2005//0104457  A1  5/2005    Jordan et al.     
 2005//0119672  A1  6/2005    Benchetrit     
 2005//0119674  A1  6/2005    Gingras     
 2005//0131383  A1  6/2005    Chen et al.     
 2005//0131485  A1  6/2005    Knudson et al.     
 2005//0136122  A1  6/2005    Sadozai et al.     
 2005//0142152  A1  6/2005    Leshchiner et al.     
 2005//0143765  A1  6/2005    Bachmann et al.     
 2005//0143766  A1  6/2005    Bachmann et al.     
 2005//0154274  A1  7/2005    Jarsaillon et al.     
 2005//0171568  A1  8/2005    Duffy     
 2005//0183730  A1  8/2005    Byrum     
 2005//0192531  A1  9/2005    Birk     
 2005//0192601  A1  9/2005    Demarais     
 2005//0192629  A1  9/2005    Saadat et al.     
 2005//0216042  A1  9/2005    Gertner     
 2005//0226936  A1  10/2005    Agerup     
 2005//0228415  A1  10/2005    Gertner     
 2005//0228504  A1  10/2005    Demarais     
 2005//0240155  A1  10/2005    Conlon     
 2005//0240156  A1  10/2005    Conlon     
 2005//0240279  A1  10/2005    Kagan et al.     
 2005//0244288  A1  11/2005    O'Neil     
 2005//0250979  A1  11/2005    Coe     
 2005//0251181  A1  11/2005    Bachmann     
 2005//0251182  A1  11/2005    Bachmann     
 2005//0267406  A1  12/2005    Hassler, Jr.     
 2005//0267500  A1  12/2005    Hassler, Jr.     
 2005//0267533  A1  12/2005    Gertner     
 2005//0271729  A1  12/2005    Wang     
 2005//0277899  A1  12/2005    Conlon et al.     
 2005//0283041  A1  12/2005    Egle     
 2005//0288739  A1  12/2005    Hassler, Jr. et al.     
 2005//0288740  A1  12/2005    Hassler, Jr. et al.     
 2006//0015138  A1  1/2006    Gertner     
 2006//0020298  A1  1/2006    Camilleri et al.     
 2006//0041183  A1  2/2006    Massen et al.     
 2006//0074439  A1  4/2006    Garner et al.     
 2006//0074473  A1  4/2006    Gertner     
 2006//0089571  A1  4/2006    Gertner     
 2006//0122147  A1  6/2006    Wohlrab     
 2006//0142700  A1  6/2006    Sobelman et al.     
 2006//0142790  A1  6/2006    Gertner     
 2006//0161139  A1  7/2006    Levine et al.     
 2006//0161186  A1  7/2006    Hassler, Jr. et al.     
 2006//0167531  A1  7/2006    Gertner et al.     
 2006//0173238  A1  8/2006    Starkebaum     
 2006//0173424  A1  8/2006    Conlon     
 2006//0183967  A1  8/2006    Lechner     
 2006//0189887  A1  8/2006    Hassler, Jr. et al.     
 2006//0189888  A1  8/2006    Hassler, Jr. et al.     
 2006//0189889  A1  8/2006    Gertner     
 2006//0194758  A1  8/2006    Lebreton     
 2006//0195139  A1  8/2006    Gertner     
 2006//0197412  A1  9/2006    Rasmussen     
 2006//0199997  A1  9/2006    Hassler, Jr. et al.     
 2006//0211912  A1  9/2006    Dlugos et al.     
 2006//0211913  A1  9/2006    Dlugos et al.     
 2006//0211914  A1  9/2006    Hassler, Jr. et al.     
 2006//0212051  A1  9/2006    Snyder et al.     
 2006//0212053  A1  9/2006    Gertner     
 2006//0235448  A1  10/2006    Roslin et al.     
 2006//0246137  A1  11/2006    Hermitte et al.     
 2006//0247721  A1  11/2006    Maschino et al.     
 2006//0247722  A1  11/2006    Maschino et al.     
 2006//0252982  A1  11/2006    Hassler, Jr.     
 2006//0252983  A1  11/2006    Lembo et al.     
 2006//0257488  A1  11/2006    Hubbard     
 2006//0264699  A1  11/2006    Gertner     
 2006//0276812  A1  12/2006    Hill et al.     
 2006//0293627  A1  12/2006    Byrum et al.     
 2007//0015954  A1  1/2007    Dlugos     
 2007//0015955  A1  1/2007    Tsonton     
 2007//0015956  A1  1/2007    Crawford et al.     
 2007//0016231  A1  1/2007    Jambor et al.     
 2007//0016262  A1  1/2007    Gross et al.     
 2007//0027356  A1  2/2007    Ortiz     
 2007//0027358  A1  2/2007    Gertner et al.     
 2007//0044655  A1  3/2007    Fish     
 2007//0077292  A1  4/2007    Pinsky     
 2007//0078476  A1  4/2007    Hull, Sr. et al.     
 2007//0125826  A1  6/2007    Shelton     
 2007//0156013  A1  7/2007    Birk     
 2007//0167672  A1  7/2007    Dlugos et al.     
 2007//0167982  A1  7/2007    Gertner et al.     
 2007//0173685  A1  7/2007    Jambor et al.     
 2007//0173888  A1  7/2007    Gertner et al.     
 2007//0179335  A1  8/2007    Gertner et al.     
 2007//0185373  A1  8/2007    Tsonton     
 2007//0185462  A1  8/2007    Byrum     
 2007//0213836  A1  9/2007    Paganon     
 2007//0218083  A1  9/2007    Brooks     
 2007//0232848  A1  10/2007    Forsell     
 2007//0232849  A1  10/2007    Gertner     
 2007//0233170  A1  10/2007    Gertner     
 2007//0235083  A1  10/2007    Dlugos     
 2007//0243227  A1  10/2007    Gertner     
 2007//0250085  A1  10/2007    Bachmann et al.     
 2007//0250086  A1  10/2007    Wiley et al.     
 2007//0255335  A1  11/2007    Herbert et al.     
 2007//0255336  A1  11/2007    Herbert et al.     
 2007//0265598  A1  11/2007    Karasik     
 2007//0265645  A1  11/2007    Birk et al.     
 2007//0265646  A1  11/2007    McCoy et al.     
 2007//0293716  A1  12/2007    Baker et al.     
 2007//0298005  A1  12/2007    Thibault     
 2008//0009680  A1  1/2008    Hassler, Jr.     
 2008//0015406  A1  1/2008    Dlugos et al.     
 2008//0015501  A1  1/2008    Gertner     
 2008//0027269  A1  1/2008    Gertner     
 2008//0027469  A1  1/2008    Bachmann     
 2008//0071306  A1  3/2008    Gertner     
 2008//0097496  A1  4/2008    Chang et al.     
 2008//0108862  A1  5/2008    Jordan et al.     
 2008//0147002  A1  6/2008    Gertner     
 2008//0161717  A1  7/2008    Gertner     
 2008//0161875  A1  7/2008    Stone     
 2008//0167647  A1  7/2008    Gertner     
 2008//0167648  A1  7/2008    Gertner     
 2008//0172072  A1  7/2008    Pool et al.     
 2008//0188766  A1  8/2008    Gertner     
 2008//0195092  A1  8/2008    Kim et al.     
 2008//0208240  A1  8/2008    Paz     
 2008//0221598  A1  9/2008    Dlugos et al.     
 2008//0243071  A1  10/2008    Quijano et al.     
 2008//0249806  A1  10/2008    Dlugos et al.     
 2008//0250340  A1  10/2008    Dlugos et al.     
 2008//0250341  A1  10/2008    Dlugos et al.     
 2008//0255403  A1  10/2008    Voegele et al.     
 2008//0255414  A1  10/2008    Voegele et al.     
 2008//0255425  A1  10/2008    Voegele et al.     
 2008//0255459  A1  10/2008    Voegele et al.     
 2008//0255537  A1  10/2008    Voegele et al.     
 2008//0275294  A1  11/2008    Gertner     
 2008//0275295  A1  11/2008    Gertner     
 2008//0275484  A1  11/2008    Gertner     
 2008//0281347  A1  11/2008    Gertner     
 2008//0287969  A1  11/2008    Tsonton et al.     
 2008//0287974  A1  11/2008    Widenhouse et al.     
 2008//0287976  A1  11/2008    Weaner et al.     
 2008//0300618  A1  12/2008    Gertner     
 2008//0319435  A1  12/2008    Rioux et al.     
 2009//0054914  A1  2/2009    Lechner     
 2009//0062825  A1  3/2009    Pool et al.     
 2009//0062826  A1  3/2009    Steffen     
 2009//0082793  A1  3/2009    Birk     
 2009//0118572  A1  5/2009    Lechner     
 2009//0149874  A1  6/2009    Ortiz et al.     
 2009//0157106  A1  6/2009    Marcotte et al.     
 2009//0157107  A1  6/2009    Kierath et al.     
 2009//0157113  A1  6/2009    Marcotte et al.     
 2009//0171375  A1  7/2009    Coe et al.     
 2009//0171378  A1  7/2009    Coe et al.     
 2009//0171379  A1  7/2009    Coe et al.     
 2009//0187202  A1  7/2009    Ortiz et al.     
 2009//0192404  A1  7/2009    Ortiz et al.     
 2009//0192415  A1  7/2009    Ortiz et al.     
 2009//0192533  A1  7/2009    Dlugos, Jr. et al.     
 2009//0192534  A1  7/2009    Ortiz et al.     
 2009//0192541  A1  7/2009    Ortiz et al.     
 2009//0198261  A1  8/2009    Schweikert     
 2009//0202387  A1  8/2009    Dlugos, Jr. et al.     
 2009//0204131  A1  8/2009    Ortiz et al.     
 2009//0204132  A1  8/2009    Ortiz et al.     
 2009//0209995  A1  8/2009    Byrum et al.     
 2009//0216255  A1  8/2009    Coe et al.     
 2009//0220176  A1  9/2009    Fusco     
 2009//0222031  A1  9/2009    Axelsson     
 2009//0222065  A1  9/2009    Dlugos, Jr. et al.     
 2009//0228063  A1  9/2009    Dlugos, Jr. et al.     
 2009//0228072  A1  9/2009    Coe et al.     
 2009//0270904  A1  10/2009    Birk et al.     
 2009//0306462  A1  12/2009    Lechner     
 2010//0010291  A1  1/2010    Birk et al.     
 2010//0049224  A1  2/2010    Vargas     
 2010//0087843  A1  4/2010    Bertolote et al.     
 2010//0099945  A1  4/2010    Birk et al.     
 2010//0100079  A1  4/2010    Berkcan     
 2010//0145378  A1  6/2010    Gertner     
 2010//0152532  A1  6/2010    Marcotte     
 2010//0168508  A1  7/2010    Gertner     
 2010//0185049  A1  7/2010    Birk et al.     
 2010//0191265  A1  7/2010    Lau et al.     
 2010//0191271  A1  7/2010    Lau et al.     
 2010//0204647  A1  8/2010    Gertner     
 2010//0204723  A1  8/2010    Gertner     
 2010//0217071  A1  8/2010    Ricol     
 2010//0226988  A1  9/2010    Lebreton     
 2010//0228080  A1  9/2010    Tavori et al.     
 2010//0234682  A1  9/2010    Gertner     
 2010//0249803  A1  9/2010    Griffiths     
 2010//0280310  A1  11/2010    Raven     
 2010//0305397  A1  12/2010    Birk et al.     
 2010//0312046  A1  12/2010    Lau et al.     
 2010//0312147  A1  12/2010    Gertner     
 2010//0324358  A1  12/2010    Birk et al.     
 2011//0201874  A1  8/2011    Birk et al.     

 
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       WO       WO 20/04/108025                         12/2004      
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       WO       WO 20/05/072195                         8/2005      
       WO       WO 20/05/087147                         9/2005      
       WO       WO 20/05/094447                         10/2005      
       WO       WO 20/05/112888                         12/2005      
       WO       WO 20/06/040647                         4/2006      
       WO       WO 20/06/049725                         5/2006      
       WO       WO 20/06/083885                         8/2006      
       WO       WO 20/06/108203                         10/2006      
       WO       WO 20/07/067206                         6/2007      
       WO       WO 20/07/081304                         7/2007      
       WO       WO 20/07/106727                         9/2007      
       WO       WO 20/07/114905                         10/2007      
       WO       WO 20/07/145638                         12/2007      
       WO       WO 20/08/063673                         5/2008      
       WO       WO 20/08/134755                         11/2008      
       WO       WO 20/09/050709                         4/2009      
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       WO       WO 20/09/136126                         11/2009      
       WO       WO 20/10/042493                         4/2010      

 OTHER PUBLICATIONS
  
  Brown et al; “Symmetrical Pouch Dilation After Laparoscopic Adjustable Gastric Banding: Incidence and Management”; Obesity Surgery; V. 18, pp. 1104-1108; 2008.
  Ceelen et al.; “Surgical Treatment of Severe Obesity With a Low-Pressure Adjustable Gastric Band: Experimental Data and Clinical Results in 625 Patients”; Annals of Surgery; V. 237, No. 1; pp. 10-16; 2003.
  Dixon et al.; “Pregnancy After Lap-Band Surgery: Management of the Band to Achieve Healthy Weight Outcomes”; Obesity Surgery; V. 11, pp. 59-65; 2001.
  Neary et al.; “Peptide YY(3-36) and Glucagon-Like Peptide-1(7-36) Inhibit Food Intake Additively”; Endocrinology; V.146; pp. 5120-5127; 2005.
  Padidela et al.; “Elevated basal and post-feed glucagon-like petide 1 (GLP-1) concentrations in the neonatel period”; European Journal of Endocrinology; v. 160; pp. 53-58; 2009.
  Shi et al.; “Sexually Dimorphic Responses to Fat Loss After Caloric Restriction or Surgical Lipectomy”; Am. J. Physiol. Endocrinol. Metab.; V. 293; E316-E326; 2007.
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     * cited by examiner
 
     Primary Examiner —Julian Woo
     Art Unit — 3773
     Exemplary claim number — 1
 
(74)Attorney, Agent, or Firm — Linda Fox; Stephen Donovan; Debra Condino

(57)

Abstract

A fatigue-resistant inflatable gastric banding device suitable for laparoscopic placement around the stomach of a patient for the treatment of obesity and a method for such treatment are disclosed. The device includes a gastric band having a chambered inflatable member, substantially coextensive with an inner stomach facing surface of the band, that does not crease, wrinkle or fold when adjusted, so as to present a substantially smooth contour along the inner circumference, and to avoid fatigue or failure of the member itself. A gastric band having multiple inflatable compartments or chambers, which may be inflated together or individually is also disclosed.
12 Claims, 6 Drawing Sheets, and 8 Figures


CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of and claims the benefit and priority of U.S. application Ser. No. 10/492,784, filed Apr. 18, 2005, now U.S. Pat. No. 7,811,298, which claims the benefit and priority of PCT Application No. PCT/US2003/026678, filed Aug. 26, 2003, which claims the benefit and priority of U.S. Provisional Patent Application No. 60/407,219, filed Aug. 28, 2002, the entire disclosure of each of these applications is incorporated herein by reference.

BACKGROUND

[0002] 1. Field of the Invention
[0003] The present invention relates generally to surgically implanted gastric bands for encircling the stomach having notches, ribs and/or chambers in the inflatable portion to reduce fatigue or crease fold failure in the device, while increasing the range of adjustment. A method for treating morbid obesity utilizing a fatigue-resistant gastric banding device is also disclosed.
[0004] 2. Description of the Related Art
[0005] A belt-like gastric band for encircling the stomach to control morbid obesity is disclosed by Vincent in U.S. Pat. No. 5,601,604, incorporated herein by reference. The band comprises a belt that can be passed around the stomach and locked into an encircling position in order to create a stoma opening within the stomach. An adjustable portion of the band comprises an inflatable member, which permits fine adjustment of the stoma opening after the stoma is created by locking the band in place. The stoma opening may be adjusted by injecting or withdrawing a fluid into or from an inflatable member. The means for injecting the fluid into the inflatable member usually comprises a fill port located beneath the skin that can be accessed extracorporeally by transdermal injection. Thus, following implantation, the gastric band can be adjusted to enlarge or reduce the stoma as required.
[0006] The gastric band is implanted surgically, via open or laparoscopic surgery, which may involve placement of a calibrating apparatus in the stomach to position the stoma and size the pouch created above the stoma. The gastric band is imbricated in position about the stomach to prevent slippage, usually by gastro-gastric sutures (i.e. tissue is wrapped over the band and sutured to itself).
[0007] As disclosed by Vincent, the inflatable member or shell is preferably substantially coextensive with an inner stomach-facing surface of the gastric band. Furthermore, it has been observed that the inflatable member should not wrinkle or fold when adjusted, so as to present a substantially smooth contour along the inner circumference. This ensures not only that stomach tissue will not be pinched by the inflatable member, which could lead to discomfort or necrosis, but also protects the shell from a phenomenon known as crease fold failure, which may occur if it is inflated beyond its intended range of adjustment. In the field, it has been observed that silicone or other elastomeric materials commonly used in the manufacture of gastric bands can fatigue or fail if repeatedly compressed, folded, wrinkled, buckled under stress or creased by, for example, over-inflation. This failure mode, which may include abrasion of the opposing surfaces against one another, abrasion of the inner surface of the fold “peak” against the opposing chamber wall, or fatigue of the material at folder intersections (the most highly-stressed areas), is sometimes referred to as crease fold failure.
[0008] In some cases, it has also been noted that existing adjustable gastric bands do not provide the overall size or range of adjustment desirable for use in particular patients. For instance, existing gastric bands may be either too large or too small to encircle a patient's stomach, while still allowing for a properly sized stoma. This may be due, for instance, to variations from patient to patient and their individual internal physiologies. Thus, gastric bands are now available in several different sizes, measured according to the circumference of the band (e.g. 9.75 cm, 11 cm, etc.). But due to variations in not only patient physiology, but also in the location and encircling position of the band, the surgical technique used, etc., it may not be evident what size band is necessary until a patient is undergoing surgery. Rather than have a variety of different sizes of gastric bands on hand during the surgical procedure, it would be desirable to have one universal size gastric band available that is adjustable over a wider range than those bands known in the prior art.
[0009] If the overall size of the gastric band is increased, the inflatable shell portion may not be capable of being adjusted to form a relatively small stoma without creases, wrinkles or folds forming on the inner stomach-facing surface, which may lead to fatigue or failure of the inflatable member, necessitating additional surgery. It would therefore be desirable to provide a universal size of a fatigue-resistant gastric band having an inflatable member that can be adjusted over a wide range of stoma openings.

OBJECTS OF THE INVENTION

[0010] The foregoing demonstrates a need for a surgically implantable gastric band having a universal size and offering a range of adjustability suitable for use in a variety of patients.
[0011] It is therefore an object of the present invention to provide a gastric band universally sized for use in patients with varying internal physiologies.
[0012] It is another object of the present invention to provide a gastric band having an inflatable member adjustable over a wider range of stoma openings than currently available devices.
[0013] It is yet another object of the present invention to provide a gastric band having an inflatable member that is substantially coextensive with an inner stomach-facing surface of the gastric band.
[0014] Still another object of the present invention is to provide a gastric band having an inflatable member that does not wrinkle or fold when adjusted over a wide range, so as to present a substantially smooth contour along the inner circumference, and to avoid fatigue or failure of the member itself.
[0015] Various other objects, advantages and features of the present invention will become readily apparent from the ensuing detailed description and the novel features will be particularly pointed out in the appended claims.

SUMMARY OF THE INVENTION

[0016] A preferred embodiment of the invention provides a fatigue-resistant gastric banding device for the treatment of morbid obesity. The device has a gastric band suited for laparoscopic placement around the stomach of a patient to form an adjustable stoma opening. The gastric band has a multi-chambered inflatable member for adjusting the inner circumference of the band. The inflatable member is preferably substantially coextensive with an inner stomach-facing surface of the gastric band. The inflatable member is chambered so as to not wrinkle or fold when adjusted over its range of adjustment, thereby presenting a substantially smooth contour along the inner circumference and reducing fatigue or failure of the device.
[0017] Another embodiment of the present invention is a gastric band having an inflatable shell including a plurality of chambers. Separating the chambers is at least one notch and/or reinforcing rib. Upon inflation of the gastric band, the chambers, ribs and/or notches eliminate creasing, folding or wrinkling of said inflatable shell, thereby reducing fatigue on the device.
[0018] Yet another embodiment of the present invention is a method of treating morbid obesity. The method of treatment includes the steps of providing a gastric band having an inflatable shell with a plurality of chambers, ribs and/or notches. A further step requires placing the gastric band around the stomach of a patient to be treated for morbid obesity, and inflating the gastric band to form a stoma.
[0019] The fatigue-resistant gastric band of the present invention may be adjusted by adding fluid to or removing fluid from the chambered inflatable member or shell by means of a subcutaneous access port, via a remotely controllable pump, using pressurized fluid or through other means well known to one skilled in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The following detailed description given by way of example, but not intended to limit the invention solely to the specific embodiments described, may best be understood in conjunction with the accompanying drawings in which:
[0021] FIG. 1 is a top view of a gastric band according to one embodiment of the present invention;
[0022] FIG. 2 is a cross-sectional view of the gastric band shown in FIG. 1 taken along line 2-2;
[0023] FIG. 3 is a top and side view of the encircling portion of a fatigue-resistant inflatable shell of the gastric band of FIG. 1;
[0024] FIG. 4 is a cross-sectional top view of the fatigue-resistant inflatable shell of FIG. 3 taken along line 4-4;
[0025] FIG. 5 is a close up cross-sectional view of a convolution point of the fatigue-resistant inflatable shell of FIG. 4 taken in area 5;
[0026] FIG. 6 is a cross-sectional view of the fatigue-resistant inflatable shell of FIG. 3 taken along line 6-6 showing the relative thickness of a reinforcing rib;
[0027] FIG. 7 is a perspective view of the encircling portion of a fatigue-resistant inflatable shell of a gastric band according to the present invention; and
[0028] FIG. 8 is a top and side view of a portion of the gastric band of FIG. 1 straightened to show the width and projection of the chambers in relation to the inner band portion.

DETAILED DESCRIPTION

[0029] An inflatable gastric band 10 according to the present invention is shown in FIG. 1. The gastric band 10 has a body portion 11 and an inflatable portion or shell 16. The body portion 11 has a head end 12 and a tail end 13. The head end 12 of the body portion 11 has a buckle 19 with a pull-tab 18. The tail end 13 includes a belt tab 17. Upon insertion of the tail end 13 including a fill tube 14 through the buckle 19, the tail end 13 is drawn through the buckle 19 until the belt tab 17 catches on the exit side 20. In this position the gastric band 10 is releasably locked in a closed loop position and secured by the buckle 19 and the belt tab 17.
[0030] The fill tube 14, which is generally a tube having a single lumen (not shown) coextensive therewith, is connected to an end of the gastric band 10. In FIG. 1 it is shown attached to the tail end 13 and in fluid communication with an inflatable shell 16. It will be apparent to one of skill in the art that other arrangements of the fill tube 14 could be made including attachment to the head end 12 without departing from the scope of the present invention.
[0031] The inflatable shell 16 is formed to receive the body portion 11 as shown in FIG. 2, which is a cross sectional view of FIG. 1 taken along line 2-2. The inflatable shell 16 is preferably substantially coextensive with the body portion 11, as shown in FIG. 1. The body portion 11 may be attached to the interior of the inflatable shell 16 through the use of adhesives compatible for use within the body or other methods known to those skilled in the art of implantable medical device manufacture. The inflatable shell 16 includes an inner stomach-facing surface 15 that forms a stoma when placed around the stomach. It is this surface that has traditionally been the location of failure due to crease fold fatigue.
[0032] To reduce the potential for crease fold failure or high stresses in the inner surface 15, the inflatable shell 16 has pre-formed stress-reducing notches 8 separating chambers 6. FIG. 3 shows a top view of the inflatable shell 16 of gastric band 10 with plurality of chambers 6 each separated by a respective notch 8. FIG. 3 differs from FIG. 1 in that it shows just the inflatable shell 16 without the inner portion 11 of the gastric band 10.
[0033] Similarly, FIG. 4 shows a cross-sectional top view of the inflatable shell 16 shown in FIG. 3. In FIG. 4, the inside of the inflatable shell 16 is depicted with reinforcing ribs 7 at each of the notches 8 separating each of the chambers 6. However, as shown in FIG. 3, the first chamber 24 and the last chamber 26 of the inflatable shell 16 may be formed with only one rib 7.
[0034] The band may be formed with a single notch 8 along the inner stomach-facing surface 15 of the inflatable shell 16, or more preferably, with multiple notches 8. Similarly, the band may be formed with a single reinforcing rib 7 inside the inflatable shell 16, or more preferably, with multiple ribs 7. Most preferably, the inflatable shell 16 is formed with corresponding ribs 7 and notches 8. The notches 8, chambers 6, and ribs 7 are formed in the inflatable shell 16 during the manufacturing process and are a feature of the inflatable shell 16 of the gastric band 10 whether filled or unfilled (i.e. whether the band is inflated or un-inflated). This helps to ensure that upon initial positioning of the gastric band 10 there is no pinching of the stomach.
[0035] FIG. 6 shows a cross sectional view of the inflatable shell 16 of FIG. 3 taken along line 6-6. In FIG. 6, the thickness of the rib 7 can be seen relative to the thickness of the inflatable shell 16. FIG. 6 also shows that the width of the chambers 6 may extend beyond the width of an outer surface 22 of the inflatable shell 16. Similarly, FIG. 8 shows the chambers 6 extending beyond the width of the body portion 11 (designated by the dotted line). The greater size of the chambers 6 relative to the body portion 11 helps to evenly distribute the forces applied to the stomach through the inflation of the gastric band 10.
[0036] FIG. 5 shows a close-up view of a notch 8 and rib 7 of the inflatable shell 16. Also shown in FIG. 5 are chambers 6 on either side of the rib 7. From FIG. 5, it can be seen that the portions of the inner surface 15 immediately adjacent to the notches 8 will not come in contact with one another upon inflation of a gastric band 10 having an inflatable shell 16 so designed. This prevents wear and rubbing of the inner surface 15. Also as a result of the notch 8, a crease will not form in the inner surface 15 of the inflatable shell 16. Further, because of this, the chamber 6 can be inflated to a much greater volume forming a smaller stoma than similar sized gastric bands known in the prior art.
[0037] The effects of the notch 8 can be described as follows: the notch 8 acts as a pre-formed crease in the inflatable shell 16. The notch 8 acts similarly to the crease that may form in gastric bands known in the prior art as it provides a point around which the body portion 11 is allowed to bend the inner surface 15 of the gastric band 10 to form a substantially circular band. One with basic geometry skills will understand that the inner surface 15 and the body portion 11 have substantially similar lengths. As a result of this, if the body portion 11 and the inflatable shell 16 are not pre-formed in a circle, when they are subsequently bent into a circular form, the interior surface 15 must in some fashion eliminate a portion of its overall length to form a circle having a smaller inner circumference than outer circumference. This reduction in circumference has heretofore occurred in prior art gastric bands through the formation of undesirable creases on the inner stomach-facing surface of the gastric band, resulting in a reduced range of inflation for such bands. The formation of these creases alleviates the material stresses in forming the circular shape, but causes point loading at the top and bottom of the creases as well as providing a point of friction between two facing sides of the crease. By forming the inflatable shell 16 in a circle with pre-formed notches 8, the aforementioned stresses are drastically reduced because the notch 8, alone or in combination with a rib 7, is formed in a fashion that prevents opposing sides of the notch 8 from buckling and reduces stress, while allowing for a great range of inflation versus prior art devices. Additionally, the effects of the point loading associated with the extremities of the crease can be alleviated by the notch 8, especially when the notch 8 is formed in conjunction with a reinforcing rib 7.
[0038] In practice, the gastric band is placed in an encircling position around the stomach using known surgical techniques, including, preferably laparoscopy. Laparoscopic placement is accomplished by introducing the fill tube 14 through a laparoscopic cannula (not shown) into the patient's abdomen. Laparoscopic placement begins with blunt dissection behind the stomach, usually two to three centimeters below the gastro-esophageal junction. Typically, the end of the fill tube 14 and the tail end 13 are passed around the stomach and drawn through the buckle 19, past the exit side 20 so that the belt tab 17 and the buckle 19 are releasably locked together. In this sense, the band is a “one-size-fits-all” device—like that described by Vincent—but because of its notched design, the gastric band is adjustable over a greater range without creasing or folding than Vincent and other known prior art bands.
[0039] The stoma—the narrow opening in the stomach created by the band—may be adjusted after the band is secured in this single position. Prior art gastric bands employ an adjustable balloon portion that is used for post-operative adjustment of the stoma as necessary. These adjustable balloons, as discussed above, are prone to creasing. The pre-formed notches 8, chambers 6 and ribs 7 of the inflatable gastric band 10 described herein provide for increased fill volumes, e.g. up to 10 cc, without wrinkles or folds forming in the shell. As in the Vincent band, the inflatable shell 16 is preferably coextensive with the inner stomach-facing surface 15 of the band between the belt tab 17 and the buckle 19. The interior of the inflatable shell 16 is in fluid communication with an injection reservoir, remote pump, pressure reservoir or other adjustment means (not shown) via fill tube 14, as with prior art adjustable gastric bands. The inflatable shell 16 is gradually inflated with saline or other biocompatible fluid via the adjustment means such that the inflatable shell 16, and in particular the inner surface 15 thereof presses on and constricts the stomach underlying the band. This results in a decrease of the opening (stoma) inside the stomach directly under the encircling gastric band 10.
[0040] During inflation of the gastric band 10, the notches 8 and the ribs 7 resist deflection. At the same time, the chambers 6 do not comparatively resist deflection. This results in the areas of the inflatable shell 16 where the ribs 7 are located forming deeper notches 8 upon inflation. Accordingly, these notches 8 reduce the stresses in the inflatable shell 16 and reduce the potential for crease fold failure by eliminating contact between the two sides of the notch 8.
[0041] Despite the addition of the notches 8 and ribs 7, the gastric band 10 forms a substantially circular constriction around the stomach upon inflation. The chambers 6 of the inflatable shell 16 direct the locations of inflation. Because of the greater deflections of the inflatable shell 16 in the chambers 6 as compared to the area of the notches 8 and ribs 7, the gastric band 10, and in particularly the inner surface 15 is prevented from pinching the surface of the stomach between two chambers 6 when in its inflated state, thereby reducing the potential for patient discomfort and necrosis.
[0042] The gastric band 10, as shown in FIG. 1, allows for greater adjustability and fill volume range than current gastric bands, while reducing the potential for fatigue failure, crease fold failure, or pinching of the stomach. Through the use of the chambers 6, notches 8, and the elimination of crease points, the inflatable shell 16 is provided a greater expandable range and is able to produce a smaller opening without fear of pinching the stomach. Similarly, because the crease points are eliminated, the likelihood of crease fold failure is also reduced. It is the possibility of pinching the stomach, and the potential for crease-fold failure that limit the operable range of currently known devices. The reduction of these possibilities increases the range of the stoma opening that may be formed with a single gastric band, while safely treating the obese patient.
[0043] Another embodiment of the present invention is an inflatable gastric band with an inflatable shell that is separated into multiple, isolated inflatable compartments or chambers. The inflation of the isolated chambers may or may not be circular, but will not crease, wrinkle or fold. Each isolated chamber may be inflated separately or simultaneously with other isolated chambers and will expand without creasing, wrinkling or folding. A compartmentalized gastric band allows for even greater adjustability and fill volume ranges than current gastric bands while reducing the potential for fatigue failure or crease fold failure.
[0044] For example, it may be desirable to reduce the size of the stoma in a particular direction. In such instances, a chamber on that side of the gastric band could be inflated without changing the size of the remaining chambers. Accordingly, greater flexibility is available in a device having isolated chambers that may be independently filled and adjusted. Such an arrangement requires independent filling pathways for each chamber.
[0045] The design of the present invention has been described for use in gastric banding devices, but may also be incorporated into any inflatable or expandable device that uses silicone or other elastomeric or polymeric materials where there may be a concern over crease fold failure.
[0046] Although the invention has been particularly shown and described with reference to certain preferred embodiments, it will be readily appreciated by those of ordinary skill in the art that various changes and modifications may be made therein, without departing from the spirit and scope of the invention. It is intended that the claims be interpreted as including the foregoing as well as various other such changes and modifications.
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Claims

1. A gastric band for the treatment of obesity suitable for laparoscopic placement around the stomach of a patient to create a stoma comprising:
a body member configured to encircle the stomach; and
an encompassing member having an inner wall and an outer wall wherein at least part of the body member is located between the inner wall and the outer wall of the encompassing member;
the inner wall being continuous along a length of the body member encircling the stomach and having an inflatable portion, the inflatable portion including at least one notch defining a plurality of chambers, wherein the plurality of chambers have a width that extends beyond the width of the outer wall, and wherein the notch is configured to substantially eliminate at least one of creasing, folding or wrinkling along the inner wall.
2. The gastric band of claim 1, wherein the chambers are in fluid communication with one another.
3. The gastric band of claim 1, wherein the chambers are further defined by at least one rib adjacent to the at least one notch.
4. The gastric band of claim 1, wherein the chambers are in fluid isolation from one another.
5. The gastric band of claim 1, wherein the encompassing member is preformed in a curved configuration.
6. The gastric band of claim 1, wherein the body member is affixed to the outer wall.
7. A gastric band for the treatment of obesity suitable for laparoscopic placement around the stomach of a patient to create a stoma comprising:
an elongated body member having connectible ends configured to encircle the stomach; and
an encompassing member having an inner wall and an outer wall wherein at least part of the body member is located between the inner wall and the outer wall of the encompassing member and is affixed to the outer wall;
the inner wall being continuous along a length of the body member encircling the stomach and having an inflatable portion, the inflatable portion including a plurality of notches defining a plurality of chambers, wherein the plurality of notches are configured to substantially eliminate at least one of creasing, folding or wrinkling along the inner wall.
8. The gastric band of claim 7, wherein the chambers extend beyond the width of the body member.
9. The gastric band of claim 7, further comprising a fill tube for inflation of the inflatable portion.
10. The gastric band of claim 7, wherein one of the connectible ends of the elongated body member further comprises a clasp for receiving a portion of the elongated body member to secure the gastric band in a curved configuration.
11. The gastric band of claim 10, wherein the connectible ends of the elongated body member are configured to be releasably secured.
12. The gastric band of claim 7, further comprising at least one rib.
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