Atraumatic delivery devices

• US 7,678,068 B2
• Filed: 12/13/2005
• Issued: 03/16/2010
• Est. Priority Date: 12/02/2002
• Status: Expired due to Fees

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Meade, John C., Levine, Andy H., Cvinar, John F.
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US11/302,977
• Publication Number:
  US 20060155312A1
• Time in Patent Office: 1,554 Days
• Field of Search: 623 2364- 2368, 623/1.24, 623/1.25, 623/1.26, 623/2.11, 623/2.14, 623/2.18, 604/8, 606/191
• 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 2017/00867 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 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 : V-shaped
• 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

Methods and apparatus for delivering an implant device within the digestive system of an animal are presented. An delivery device includes an outer sheath, or container, for storing a proximal portion of the implant device. The outer sheath is moveable relative to the stored portion of the implant device to release the proximal portion from within the outer sheath. The delivery device also includes an inner sheath defining a lumen therein that extends distal to the outer sheath, a moveable element adapted to secure the distal end of the implant to the inner sheath, and a release mechanism coupled to the moveable element for releasing the distal end of the implant. The device also includes a atraumatic tip, or ball, coupled at its distal end to facilitate guiding the delivery device through the gastrointestinal tract.

Claims

1. A method for delivering a gastrointestinal device in a body comprising the steps of:

providing a delivery system including an outer sheath and an inner sheath disposed therein,

securing a distal portion of a gastrointestinal device outside of the inner sheath, the distal portion being a floppy sleeve surrounding the inner sheath;

guiding the delivery system through the alimentary canal with a ball coupled to a distal end of the inner sheath distal to the sleeve, the outer sheath extending through the stomach and the inner sheath extending through the intestine.

2. The method of claim 1, wherein the delivery system is used for delivering the gastrointestinal device, a proximal portion of the gastrointestinal device comprising a self-expanding anchor and a distal portion comprising the sleeve.

3. The method of claim 2, wherein the proximal end of the device is stored within the outer sheath and outside of the inner sheath.

4. The method of claim 3, wherein the distal end of the device is secured outside of the inner sheath.

5. The method of claim 3 wherein the sleeve is releasably secured to the inner sheath using a sleeve retention device.

6. The method of claim 2, wherein the gastrointestinal device is anchored in the stomach.

7. The method of claim 2, wherein the gastrointestinal device is anchored distal to the pylorus.

8. The method of claim 2, wherein the gastrointestinal device is retained within the pyloric orifice.

9. The method of claim 2, further comprising the steps of selectively releasing a distal end of the sleeve.

10. The method of claim 2, further comprising releasing the anchor from the outer sheath and expanding the anchor to anchor the gastrointestinal device.

11. The method of claim 10, wherein expanding the anchor comprises the step of selectively releasing the anchor from the outer sheath.

12. The method of claim 11 wherein the step of selectively releasing the anchor from outer sheath comprises pulling the outer sheath toward the proximal end of the delivery system.

13. The method of claim 1, further comprising the step of passing the delivery system over a guidewire.

14. The method of claim 13 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.

15. The method of claim 14, further comprising the step of retracting the ball through a central lumen of the gastrointestinal device after the distal end of the sleeve is released.

16. The method of claim 1, wherein the inner sheath defines a lumen.

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

providing a delivery system including an outer sheath and an inner sheath disposed therein;

storing a proximal portion of the gastrointestinal device within the outer sheath and outside of the inner sheath;

securing a distal portion of the gastrointestinal device outside of the inner sheath, the distal portion being a sleeve surrounding the inner sheath;

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

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

releasing the proximal end of the gastrointestinal device from the outer sheath.

18. The method of claim 17, wherein the proximal end of the gastrointestinal device is a self-expanding anchor.

19. The method of claim 17 wherein the sleeve is releasably secured to the inner sheath using a sleeve retention device.

20. The method of claim 17, wherein the gastrointestinal device is anchored in the stomach.

21. The method of claim 17, wherein the gastrointestinal device is anchored distal to the pylorus.

22. The method of claim 17, wherein the gastrointestinal device is retained within the pyloric orifice.

23. The method of claim 17, further comprising the step of passing the delivery system over a guidewire.

24. The method of claim 17, further comprising the step of retracting the ball through a central lumen of the gastrointestinal device after the distal end of device is released.