Bariatric sleeve delivery devices

• US 7,758,535 B2
• Filed: 12/11/2007
• Issued: 07/20/2010
• Est. Priority Date: 12/02/2002
• Status: Expired due to Fees

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, Dave, Levine, Andy H.
• Primary Examiner(s): Stewart; Alvin J
• Application Number:
  US12/001,365
• Publication Number:
  US 20080097466A1
• Time in Patent Office: 952 Days
• Field of Search: 604/8, 623/23.64, 623/23.65, 623/23.66, 623/23.68, 606/108, 606/151, 606/191, 600/37
• US Class Current: 604/8
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00238 Type of minimally invasive operation A61B2017/00805 takes precedence
• CPC Class Codes: A61B 2017/0084 low friction A61B2017/00853 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 : provided on at least one of the ends
• CPC Class Codes: A61F 2002/9528 : for retrieval of stents
• CPC Class Codes: A61F 2210/0076 : multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 5/0076 : preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61F 5/0089 : Instruments for placement or removal

Abstract

Method and apparatus for limiting absorption of food products in specific parts of the digestive system is presented. A gastrointestinal implant device is anchored in the stomach and extends beyond the ligament of Treitz. All food exiting the stomach is funneled through the device. The gastrointestinal device includes an anchor for anchoring the device to the stomach and a flexible sleeve to limit absorption of nutrients in the duodenum. The anchor is collapsible for endoscopic delivery and removal.

Claims

1. A delivery system for placing a gastrointestinal implant device in a body comprising:

a gastrointestinal implant having a flexible sleeve open at both ends;

an outer sheath adapted for storing a proximal portion of the gastrointestinal implant device;

an inner sheath within the outer sheath, the inner sheath defining a lumen and extending distally beyond the outer sheath;

a ball coupled on the distal end of the inner sheath and adapted to guide the delivery system through the alimentary canal; and

a moveable element moveable within the lumen of the inner sheath and adapted to secure the distal end of the gastrointestinal implant device to the inner sheath during delivery.

2. The delivery system of claim 1, wherein the ball is dimensioned to permit it to be pulled-back through a central lumen of the gastrointestinal implant device.

3. The delivery system of claim 1, further comprising:

an anchor release mechanism adapted to release an anchor from the outer sheath, the anchor being coupled to the proximal end of the gastrointestinal implant device; and

a sleeve release mechanism coupled to the moveable element and adapted to release the distal end of a sleeve, the sleeve being coupled at its proximal end to the anchor.

4. The delivery system of claim 3 wherein the anchor release mechanism is adapted to pull the outer sheath toward the proximal end of the delivery system to remove the outer sheath from the anchor.

5. The delivery system of claim 4 wherein the sleeve release mechanism is adapted to pull the moveable element toward the proximal end of the delivery system to release the distal end of the sleeve after the anchor has been released.

6. The delivery system of claim 1 wherein the moveable element is a sleeve retention wire exiting the lumen of the inner sheath and piercing the distal end of the sleeve.

7. The delivery system of claim 1, wherein the gastrointestinal device is adapted for anchoring distal to the pylorus.

8. The delivery system of claim 1, wherein the gastrointestinal device is adapted to be retained within the pyloric orifice.

9. The delivery system of claim 1, wherein the inner sheath defines a second lumen adapted to pass the outer sheath over a guidewire.

10. A delivery system for placing a gastrointestinal implant device in a body comprising:

a gastrointestinal implant device including a self-expanding anchor for proximally anchoring the device and a sleeve coupled to the anchor;

an outer sheath adapted to store a proximal portion of the gastrointestinal implant device;

an inner sheath within the outer sheath, the inner sheath defining a lumen and extending distally beyond the outer sheath;

a moveable element moveable within the lumen of the inner sheath and adapted to secure the distal end of the sleeve to the inner sheath;

an anchor release mechanism adapted to release the anchor from the outer sheath; and

a sleeve release mechanism coupled to the moveable element adapted for releasing the distal end of the sleeve.

11. A delivery system for placing a gastrointestinal implant device in a body comprising:

an outer sheath to store therewithin a proximal portion of the gastrointestinal implant device, the proximal portion of the gastrointestinal implant device including a self-expanding sleeve anchor to anchor the device, the outer sheath moveable relative to the sleeve anchor to release the sleeve anchor from within the outer sheath;

an inner sheath within the outer sheath, the inner sheath defining a lumen and extending distal to the outer sheath;

a moveable element moveable within the lumen of the inner sheath to secure a distal end of a sleeve to the inner sheath, the sleeve coupled at its proximal end to the sleeve anchor;

a sleeve release mechanism coupled to the moveable element to release the distal end of the sleeve; and

a ball disposed on the distal portion of the delivery system.

12. The delivery system of claim 11, wherein the moveable element is a sleeve retention wire, which exits the lumen of the inner sheath and pierces the distal end of the sleeve.

13. The delivery system of claim 11, wherein the outer sheath is pulled toward a proximal end of the delivery system to remove the sleeve anchor from the outer sheath.

14. The delivery system of claim 13 wherein the sleeve release mechanism pulls the moveable element toward the proximal end of the delivery system to release the distal end of the sleeve after the sleeve anchor has been released.

15. The delivery system of claim 11, wherein the gastrointestinal device is anchored in the stomach.

16. The delivery system of claim 11, wherein the gastrointestinal device is anchored distal to the pylorus.

17. The delivery system of claim 11, wherein the ball is coupled to the distal end of the inner sheath.

18. The delivery system of claim 11, wherein the ball is dimensioned to permit its retraction through a central lumen of the gastrointestinal implant device.

19. The delivery system of claim 11, wherein the inner sheath defines a second lumen to pass the outer sheath over a guidewire.

20. The delivery system of claim 11, wherein the sleeve anchor comprises a stent.

33. The delivery system of claim 11, wherein the ball is spherical.

21. A delivery system for placing a gastrointestinal implant device in a body comprising:

an outer sheath to store therewithin a proximal portion of the gastrointestinal implant device, the proximal portion of the gastrointestinal implant device including a self-expanding sleeve anchor to anchor the device, the outer sheath moveable relative to the sleeve anchor to release the sleeve anchor from within the outer sheath;

an inner sheath within the outer sheath, the inner sheath extending distal to the outer sheath toward the distal end of the delivery system, a first lumen within the inner sheath to pass the outer sheath over a guidewire and a second lumen within the inner sheath to move a sleeve retention wire to secure the distal end of a sleeve coupled to the sleeve anchor to the inner sheath by exiting the second lumen of the inner sheath and piercing the distal end of the sleeve;

a sleeve release mechanism coupled to the moveable element to release the distal end of the sleeve; and

a ball disposed on the distal portion of the delivery system.

22. The delivery system of claim 21, wherein the outer sheath is pulled toward the proximal end of the delivery system to remove the sleeve anchor from the outer sheath.

23. The delivery system of claim 22, wherein the sleeve release mechanism pulls the moveable element toward the proximal end of the delivery system to release the distal end of the sleeve after the sleeve anchor has been released.

34. The delivery system of claim 21, wherein the ball is spherical.

24. A delivery system for placing a gastrointestinal implant device in a body comprising:

a gastrointestinal implant device comprising a self expanding sleeve anchor and a sleeve coupled at its proximal end to the sleeve anchor;

an outer sheath storing the self-expanding sleeve anchor in a compressed state within the outer sheath, the outer sheath moveable relative to the sleeve anchor to release the sleeve anchor from within the outer sheath to radially expand;

an inner sheath within the outer sheath, the inner sheath defining a lumen and extending distal to the outer sheath;

a moveable element moveable within the lumen of the inner sheath and securing a distal end of the sleeve to the inner sheath;

a sleeve release mechanism coupled to the moveable element to move the moveable element and thus release the distal end of the sleeve and

a ball disposed on the distal portion of the delivery system.

25. The delivery system of claim 24, wherein the moveable element is a sleeve retention wire, which exits the lumen of the inner sheath and pierces the distal end of the sleeve.

26. The delivery system of claim 24, wherein the outer sheath is pulled toward a proximal end of the delivery system to remove the sleeve anchor from the outer sheath.

27. The delivery system of claim 26, wherein the sleeve release mechanism pulls the moveable element toward the proximal end of the delivery system to release the distal end of the sleeve after the sleeve anchor has been released.

28. The delivery system of claim 24, wherein the gastrointestinal device is anchored distal to the pylorus.

29. The delivery system of claim 24, wherein the sleeve anchor comprises a stent.

30. The delivery system of claim 24, wherein the ball is coupled to the distal end of the inner sheath.

31. The delivery system of claim 24, wherein the ball is dimensioned to permit its retraction through a central lumen of the gastrointestinal implant device.

32. The delivery system of claim 24, wherein the ball is spherical.