Atraumatic delivery devices

• US 20060155312A1
• Filed: 12/13/2005
• Published: 07/13/2006
• Est. Priority Date: 12/02/2002
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Meade, John C., Levine, Andy H., Cvinar, John F.
• Granted Patent: US 7,678,068 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• 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
• 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
• CPC Class Codes: A61B 2017/061 hollow or tubular
• 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 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 spherical element disposed at the distal portion of the delivery system.

2. The delivery system of claim 1, 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.

3. The delivery system of claim 1, wherein the moveable element is a snare wire which captures the distal end of the sleeve.

4. The delivery system of claim 1, wherein the outer sheath is pulled toward a proximal end of the delivery system to remove the sleeve anchor from the outer sheath.

5. The delivery system of claim 4 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.

6. The delivery system of claim 1, wherein the gastrointestinal device is anchored in the stomach.

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

8. The delivery system of claim 1, wherein the spherical element is coupled to the distal end of the inner sheath.

9. The delivery system of claim 1, wherein the spherical element is dimensioned to permit its retraction through a central lumen of the gastrointestinal implant device.

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

11. The delivery system of claim 1, wherein the sleeve anchor comprises a stent.

12. 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 spherical element disposed at the distal portion of the delivery system.

13. The delivery system of claim 12, wherein the outer sheath is pulled toward the 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. 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 snare wire to secure the distal end of a sleeve coupled to the sleeve anchor to the inner sheath by capturing 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 spherical element disposed at the distal portion of the delivery system.

16. The delivery system of claim 15, wherein the outer sheath is pulled toward the proximal end of the delivery system to remove the sleeve anchor from the outer sheath.

17. The delivery system of claim 16, 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.

19. The delivery system of claim 17, 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.

20. The delivery system of claim 17, wherein the moveable element is a snare wire which captures the distal end of the sleeve.

21. The delivery system of claim 17, wherein the outer sheath is pulled toward a proximal end of the delivery system to remove the sleeve anchor from the outer sheath.

22. The delivery system of claim 20, 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.

23. The delivery system of claim 17, wherein the gastrointestinal device is anchored distal to the pylorus.

24. The delivery system of claim 17, wherein the sleeve anchor comprises a stent.

25. The delivery system of claim 17, wherein the spherical element is coupled to the distal end of the inner sheath.

26. The delivery system of claim 17, wherein the spherical element is dimensioned to permit its retraction through a central lumen of the gastrointestinal implant device.

28. The delivery system of claim 26, wherein the ball is coupled to the distal end of the inner sheath.

29. The delivery system of claim 26, wherein the ball is dimensioned to permit its retraction through a central lumen of the gastrointestinal implant device.

18. 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 spherical element disposed at the distal portion of the delivery system.

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

an outer sheath to store 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;

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;

an anchor release mechanism to release the sleeve anchor from the outer sheath;

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

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