Methods and devices for placing a gastrointestinal sleeve

• US 7,837,643 B2
• Filed: 02/14/2005
• Issued: 11/23/2010
• Est. Priority Date: 07/09/2004
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Lamport, Ronald B., Levine, Andy H.
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): SU, SUSAN SHAN
• Application Number:
  US11/057,861
• Publication Number:
  US 20060009858A1
• Time in Patent Office: 2,108 Days
• Field of Search: 604/8, 623/23.65
• US Class Current: 604/8
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• 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

Methods and systems for delivering or placing a gastrointestinal implant device into a mammal. The gastrointestinal implant device can be used to limit absorption of food products in specific parts of the digestive system and can include a gastrointestinal sleeve having an anchor portion and a barrier or sleeve portion. The methods include endoluminal delivery of the device.

Claims

1. A method of placing a gastrointestinal implant device in a mammal, comprising the steps of:

placing a gastrointestinal implant device in a container assembly, the implant device including an anchor and a floppy sleeve, the sleeve coupled to the anchor and folded into the container assembly;

directing the container assembly, with the anchor and folded sleeve stored therein, into a mammalian gastrointestinal tract;

removing at least a portion of the floppy sleeve from the container assembly by extending a portion of the floppy sleeve from the anchor and from container assembly to a location in the gastrointestinal tract that is distal relative to the assembly while the anchor is retained in the assembly; and

subsequently removing the anchor from the container assembly and securing the anchor to a location in the gastrointestinal tract.

2. The method of claim 1, wherein the sleeve is extended to the location by advancing a catheter having an atraumatic tip.

3. The method of claim 2, wherein a distal portion of the catheter is less rigid than a proximal portion of the catheter.

4. The method of claim 1, wherein the assembly is directed to the duodenum of the gastrointestinal tract.

5. The method of claim 1, wherein at least a portion of the sleeve is directed into the jejunum of the gastrointestinal tract.

6. The method of claim 1, wherein the anchor is secured in the duodenum of the gastrointestinal tract.

7. The method of claim 1, wherein the anchor is self-expanding.

8. The method of claim 1, further including a step of directing a fluid into the gastrointestinal tract.

9. The method of claim 8, wherein the fluid is directed into the gastrointestinal tract before the assembly is directed into the duodenum.

10. The method of claim 8, wherein the fluid is directed into the gastrointestinal tract after the assembly is directed into the duodenum.

11. The method of claim 1, wherein the assembly includes a first chamber and the step of placing the device in the assembly includes storing the anchor in the first chamber.

12. The method of claim 11, wherein the step of removing the device from the assembly includes directing at least a portion of the floppy sleeve to a location in the gastrointestinal tract that is distal relative to the first chamber while the anchor is releasably secured in the first chamber.

13. The method of claim 11, wherein the assembly further includes a second chamber and the step of placing the device in the assembly includes storing at least a portion of the floppy sleeve in the second chamber.

14. The method of claim 13, wherein the step of removing the device from the assembly includes directing the second chamber to a location in the gastrointestinal tract that is distal relative to the first chamber while the anchor is releasably secured in the first chamber and the floppy sleeve is releasably secured in the second chamber.

15. The method of claim 1, wherein the portion of the floppy sleeve is extended by pulling the portion of the floppy sleeve with an extension that moves relative to the anchor.

16. The method of claim 1, wherein the anchor is retained in the assembly by an anchor lock as the portion of the floppy sleeve is extended.

17. A delivery system for placing a gastrointestinal implant device in a mammalian gastrointestinal tract comprising:

a container assembly;

a gastrointestinal implant device that includes a proximal end and a distal end stored within the container assembly, the proximal end including an anchor and the distal end including a floppy sleeve, coupled to the anchor and folded into the container assembly;

a delivery extension configured to deliver the container assembly into the gastrointestinal tract with the anchor and floppy sleeve stored within the container assembly; and

an inner extension to draw a portion of the sleeve from the anchor and from the container assembly as the anchor is retained therein.

18. The system of claim 17, further including an anchor locking mechanism located within the assembly.

19. The system of claim 18, wherein the anchor locking mechanism includes an anchor locking wire that extends through a portion of the device.

20. The system of claim 17, wherein the inner extension is a catheter releasably secured to the distal end of the sleeve.

21. The system of claim 20, wherein the catheter includes an atraumatic tip.

22. The system of claim 17, further including an anchor plunger for displacing the anchor from the container assembly.

23. The system of claim 17, wherein the anchor is self-expanding.

24. The system of claim 17, wherein the assembly includes a first chamber and a second chamber, the first chamber storing at least a portion of the proximal end and the second chamber storing at least a portion of the distal end.

25. The system of claim 24, wherein at least a portion of the second chamber is stored in the first chamber.