MINIMALLY INVASIVE, DIRECT DELIVERY METHODS FOR IMPLANTING OBESITY TREATMENT DEVICES

• US 20110172767A1
• Filed: 01/27/2011
• Published: 07/14/2011
• Est. Priority Date: 04/19/2006
• Status: Abandoned Application

• Current Assignee: Reshape Medical, Inc. (ReShape LifeSciences, Inc.)
• Original Assignee: Reshape Medical, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Bright, Earl A. II, Bender, Theodore M., Makower, Joshua, George, Robert M., Rathi, Pankaj, Newell, Matthew B., Uemura, Shuji, Brooks, Narvel M. III, Acosta, Pablo G., Dreissigacker, Marlo, Johnson, Dane A., Shiu, Brian K., Lee, Crystine M.
• Application Number:
  US13/015,086
• Publication Number:
  US 20110172767A1
• Time in Patent Office: Days
• US Class Current: 623/11.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0092 for X-rays
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments by marking A61B2090/395
• CPC Class Codes: A61B 2017/3405 using mechanical guide means
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3447 Linked multiple cannulas
• CPC Class Codes: A61B 2017/3449 whereby the instrument channels merge into one single channel
• CPC Class Codes: A61B 2017/349 Trocar with thread on outside
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/395 : with marking agent for marking skin or other tissue
• CPC Class Codes: A61F 5/0003 : Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/003 : inflatable
• CPC Class Codes: A61F 5/0073 : in the abdominal cavity, e.g. not attached to the stomach
• CPC Class Codes: A61F 5/0089 : Instruments for placement or removal
• CPC Class Codes: A61M 25/0069 : Tip not integral with tube
• CPC Class Codes: Y10T 156/10 : Methods of surface bonding and/or assembly therefor

Abstract

A method includes selecting a template from a plurality of different sizes of templates based on measurements of the abdominal cavity of a patient; orienting the template on the patient at a location overlying the abdominal cavity to select an appropriate size implant using fluoroscopic imaging; marking an incision location and an indicator of an angle of approach; and removing the template from the patient, wherein marks made by the marking remain on the patient. Methods apparatus, instruments and implants for treating a patient are provided.

Claims

1. A method comprising:

selecting a template from a plurality of different sizes of templates based on measurements of the abdominal cavity of a patient;

orienting said template on the patient at a location overlying the abdominal cavity to select an appropriate size implant;

marking an incision location and an indicator of an angle of approach; and

removing said template from the patient, wherein marks made by said marking remain on the patient.

2. The method of claim 1, comprising using fluoroscopic imaging to facilitate selection of said appropriate size implant.

3. The method of claim 1, further comprising selecting said appropriate size implant from a plurality of different sizes of implants.

4. The method of claim 1, wherein said implants are enlargeable implants.

5. The method of claim 1, further comprising:

marking the patient at a location overlying a portion of the costal margin, prior to said orienting, and wherein said orienting includes positioning a superior edge of a cutout in said template adjacent to or inferior of a mark made by said marking of the location overlying a portion of the costal margin.

6. The method of claim 1, further comprising adhering a marking guide to an indicator location as said indicator of the angle of approach.

7. The method of claim 1, wherein said template includes a cutout indicating a location where said implant is to be attached to the abdominal wall, and wherein said indicator of the angle of approach comprises a mark drawn within bounds of said cutout.

8. The method of claim 6, further comprising adhering a marking guide to the patient so that said marking guide overlies said mark drawn within bounds of said cutout.

9. The method of claim 1, further comprising positioning said template so that a head of said template approximates the diaphragm of the patient, but does not extend superiorly of the diaphragm.

10. The method of claim 1, wherein said marking the incision location comprises marking adjacent to a notch in a tail of said template or inferior of said notch, adjacent to a portion of said tail inferior of said notch.

11. The method of claim 1, further comprising adhering a marking guide to a location overlying a portion of the costal margin.

12. The method of claim 5, further comprising adhering a marking guide to the patient, wherein said marking guide overlies a mark made by said marking the patient at a location overlying a portion of the costal margin.

13. The method of claim 1, further comprising placing a suture marker that extends along the internal surface of the abdominal wall along the inferior edge of a portion of the costal margin of the patient.

14. The method of claim 4, further comprising:

making an incision or puncture through the patient'"'"'s skin at said marked incision location;

establishing a delivery tract through an opening formed by said incision or puncture, subcutaneous fat and fascia and into the patient'"'"'s abdominal cavity, but not through the stomach;

dilating the opening and placing an introducer cannula along the tract such that said introducer cannula extends from a location outside of the patient to a location within the abdominal cavity;

inserting an instrument and said selected enlargeable implant into said introducer cannula, wherein said enlargeable implant is mounted on a distal end portion of said instrument and said enlargeable implant is in a compact configuration;

enlarging said implant to an enlarged configuration;

attaching said implant to an inner surface of the abdominal cavity;

removing said instrument and introducer cannula;

attaching an adjustment member to a fill tube in fluid communication with said implant; and

closing the opening.

15. The method of claim 14, further comprising:

prior to said enlarging said implant to an enlarged configuration, retracting said introducer cannula relative to said instrument and implant to expose said implant and a working end of said instrument out of a distal end of said introducer cannula.

16. The method of claim 14, further comprising:

prior to said attaching said implant, contacting a lowermost rib of the patient with a depression formed in a distal end portion of the instrument extending distally of an end effector of said instrument.

17. The method of claim 14, further comprising:

attaching a sealing member mounted on said instrument to a proximal end of said introducer cannula to seal off said introducer cannula; and

insufflating the abdominal cavity of the patient.

18. The method of claim 14, further comprising:

prior to said attaching said implant, verifying a correct positioning of said implant by verifying alignment of said instrument with said indicator of the angle of approach.

19. The method of claim 14, further comprising:

prior to said attaching said implant, verifying a correct positioning of said implant by verifying alignment of said instrument with at least one of said indicator of the angle of approach and said suture marker.

20. The method of claim 14, further comprising:

prior to said attaching, verifying a position of a working end of said instrument relative to said marking guide that overlies a portion of the costal margin.

21. The method of claim 14, further comprising verifying, using direct laparoscopic visualization, a location of a distal end of an end effector of said instrument relative to the costal margin of the patient.

22. The method of claim 14, wherein said dilating the opening and placing an introducer cannula comprises inserting a distal end of a dilator through the opening, wherein said introducer cannula is mounted over said dilator and a distal end portion of said introducer cannula is passed through the abdominal wall along the tract;

the method further comprising removing said dilator prior to said inserting an instrument and enlargeable implant into said introducer cannula; and

insufflating the abdominal cavity.

23. The method of claim 14, wherein the opening is the only opening formed in the patient to carry out the entirety of the method.

24. The method of claim 14, wherein said implant is attached to fascia and/or peritoneum.

25. The method of claim 14, wherein said implant is attached to abdominal muscle.

26. The method of claim 14, wherein said instrument comprises an attachment tool and a suturing tool that are releasably connected to one another, wherein said attaching comprises attaching said implant using said attachment tool, and then disconnecting said attachment tool from said suturing tool and removing said attachment tool from said introducer cannula.

27. The method of claim 26, further comprising tightening the attachment of said implant to the inner surface of the abdominal cavity using said suturing tool;

and wherein said removing said instrument comprises removing said suturing tool after completing said tightening said attachment.

28. The method of claim 14, further comprising removing at least a portion of a falciform ligament.

29. An apparatus for use in a minimally-invasive abdominal surgical procedure, said apparatus comprising:

an elongate introducer cannula having a tubular main body, a distal end, a proximal end and a main lumen extending therethrough;

a stitching instrument having at least one elongate shaft insertable through said introducer cannula, said instrument having a length greater than a length of said elongate introducer;

a sealing member forming a seal around said at least one elongate shaft of said instrument and configured to form a seal between said instrument and said introducer cannula to seal off said main lumen; and

an enlargeable implant releasably attached to a distal end portion of said instrument.

30. The apparatus of claim 29, wherein said stitching instrument comprises an attachment tool and a suturing tool that are releasably connected to one another, wherein said attaching comprises an end effector having needles configured to drive stitches to attach said implant to a patient.

31. A sealing member for forming a seal between an introducer cannula and an attachment tool configured to attach an implant in the abdominal cavity, said sealing member comprising:

a main body having a generally circular cross-sectional configuration;

attachment members configured and dimensioned to attach to a proximal end of said introducer cannula;

a sealing ring configured to seal with an opening in fluid communication with a main lumen of said introducer cannula;

an opening configured to allow passage of an end effector having a first cross-sectional area, as well as a shaft having a second cross-sectional area different from said first cross-sectional area; and

a valve formed around the opening and configured to form a seal with said shaft.

32. The sealing member of claim 31, wherein said opening comprises a first opening and said valve comprises a first valve, said sealing member comprising a second opening for receiving a tool or instrument therethrough and forming a seal therewith, and a second sealing member formed around said second opening.

33. An implantable device for treatment of obesity, said device comprising:

an expandable main body member configured to be positioned adjacent a portion of a stomach of a patient, within the abdominal cavity of the patient wherein said expandable main body member comprises a wall surrounding an internal chamber;

an attachment tab interfacing with an outer surface of said wall and extending from said wall of said expandable main body member, said attachment tab configured to fix a portion of said main body member to and in contact with a portion of at least one internal body structure;

an inner backing layer interfacing with an inner surface of said wall and bonded thereto; and

wherein said attachment tab, said wall and said inner backing layer, are bonded together.

34. The device of claim 33, wherein said attachment tab and said inner backing layer are bonded together through at least one opening through said wall and wherein each said opening is sealed by the bonding together of said attachment tab and said inner backing layer.

35. The device of claim 33, further comprising a plug bonded to said attachment tab, said wall and said inner backing layer, said plug having placed in an opening in said wall, said plug having been bonded with said attachment tab, wall and inner backing layer, thereby filling said opening in which said plug was inserted prior to having been bonded.

36. A method of making an implantable device for treatment of obesity, said method comprising:

providing an expandable main body member configured to be positioned adjacent a portion of a stomach of a patient, within the abdominal cavity of the patient wherein said expandable main body member comprises a wall surrounding an internal chamber and an opening through said wall;

laying a layer of an attachment tab on an outer surface of said wall over a location of said opening;

contacting an inner backing layer to an inner surface of said wall under a location of said opening; and

bonding said wall, layer of an attachment tab and inner backing layer together.

37. The method of claim 36, further comprising:

inserting a plug in said opening; and

wherein said bonding comprises bonding said wall, said plug, said layer of an attachment tab and said inner backing layer together.

38. The method of claim 36, wherein said bonding comprises vulcanizing.

39. The method of claim 37, wherein said bonding comprises vulcanizing.