Bariatric sleeve delivery devices

• US 20050080491A1
• Filed: 11/30/2004
• Published: 04/14/2005
• Est. Priority Date: 12/02/2002
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Levine, Andy H., Melanson, Dave
• Granted Patent: US 7,329,285 B2
• Time in Patent Office: Days
• US Class Current: 623/23.650
• 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:

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; and

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

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:

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;

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 moveable element is a snare wire adapted for capturing the distal end of the gastrointestinal implant device.

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

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

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

11. A method for placing a gastrointestinal implant device in a body comprising the steps of:

providing a delivery system including an outer sheath and an inner sheath disposed therein, the inner sheath defining a lumen;

storing a proximal portion of the gastrointestinal implant device within the outer sheath, the proximal portion of the gastrointestinal implant device including a self-expanding anchor for anchoring the device;

guiding through the alimentary canal a ball coupled to the distal portion of the delivery system;

releasing a distal end of the gastrointestinal implant device from the inner sheath; and

expanding the anchor to anchor the gastrointestinal implant device.

12. The method of claim 11 wherein the sleeve is releasably secured to the inner sheath using a sleeve retention device.

13. The method of claim 11, wherein the gastrointestinal device is anchored in the stomach.

14. The method of claim 11, wherein the gastrointestinal device is anchored distal to the pylorus.

15. The method of claim 11, wherein the gastrointestinal device is retained within the pyloric orifice.

16. The method of claim 11, further comprising the step of passing the outer sheath over a guidewire.

17. The method of claim 11, further comprising the steps of selectively releasing the distal end of the sleeve.

18. The method of claim 17 wherein the step of selectively releasing the distal end of the sleeve comprises pulling a moveable element toward the proximal end of the delivery system.

19. The method of claim 18, further comprising the step of retracting the ball through a central lumen of the gastrointestinal implant device after distal end of the sleeve is released.

20. The method of claim 11, wherein expanding the anchor comprises the step of selectively releasing the anchor from the outer sheath.

21. The method of claim 20 wherein the step of selectively releasing the anchor from outer sheath comprises pulling the outer sheath toward the proximal end of the delivery system.

22. 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.

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

means for storing a proximal portion of the gastrointestinal implant device during placement, the proximal portion of the gastrointestinal implant device including a self-expanding anchor for anchoring the device;

means for guiding through the alimentary canal a distal portion of the delivery system;

means for securing the distal end of the gastrointestinal implant to the delivery system during placement; and

means for selectively releasing a distal end of the gastrointestinal implant device from the delivery system.

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

a catheter adapted for passage through the intestines;

a gastrointestinal implant device releasably coupled to the catheter; and

a ball coupled to the distal end of the catheter.

25. The delivery system of claim 24, wherein the gastrointestinal implant device comprises a sleeve.

26. The delivery system of claim 25, wherein the gastrointestinal implant device further comprises a sleeve anchor coupled to the sleeve.

27. The delivery system of claim 26, wherein the sleeve anchor is a stent.