Atraumatic Gastrointestinal Anchor

• US 20110004230A1
• Filed: 09/15/2010
• Published: 01/06/2011
• Est. Priority Date: 09/17/2004
• Status: Abandoned Application

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Meade, John C., Levine, Andy H.
• Application Number:
  US12/882,606
• Publication Number:
  US 20110004230A1
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/9534 for repositioning 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/0037 : differing in height or in length
• CPC Class Codes: A61F 5/0076 : preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

The present invention relates to methods and articles for anchoring within a natural bodily lumen. An anchor is adapted to provide differing radially-outward forces along its length, a securing force and a transitional force. Production of these forces can be controlled by varying a physical property of the anchor, such as its stiffness, thickness, or shape. For example, the stiffness of an elongated anchor can be varied from a relatively soft value at its proximal and distal ends to a relatively stiff value at its center by varying the diameter of wire forming the anchor, thereby tailoring it to an intended application. Such force tailoring can be combined with external barbs and used to reliably anchor other instruments, such as feeding tubes and intestinal sleeves.

Claims

1. An intraluminal implant comprising:

an anchor configured to be implanted within a natural bodily lumen, the anchor comprising a plurality of wave-shaped anchoring elements, at least one of the plurality of anchoring elements comprising at least one external barb configured to penetrate muscular tissue of the natural bodily lumen, the respective anchoring element expanding against the lumen and configured to hold the barb against the muscular tissue; and

a flexible, elongated sleeve coupled at its proximal end to the anchor, the sleeve configured to extend distally beyond the anchor within the natural bodily lumen.

2. The intraluminal implant of claim 1, wherein the anchor comprises two of the wave-shaped anchoring elements.

3. The intraluminal implant of claim 1, wherein the anchor comprises three of the wave-shaped anchoring elements.

4. The intraluminal implant of claim 3, wherein at least one external barb extends from a central anchoring element and the central anchoring element is stiffer than two end anchoring elements.

5. The intraluminal implant of claim 1, wherein the sleeve is floppy.

6. The intraluminal implant of claim 1, wherein the external barb is a bi-directional barb, comprising a first barb segment configured to oppose proximal movement and a second barb segment configured to oppose distal movement.

7. The intraluminal implant of claim 1, wherein the elongated sleeve is configured to be anchored in the proximal duodenum, the sleeve extending distally within the intestine.

8. The intraluminal implant of claim 1, wherein the elongated sleeve is thin-walled, collapsing upon itself.

9. The intraluminal implant of claim 1, wherein the anchor is coupled to the sleeve between overlapping layers of the sleeve.

10. The intraluminal implant of claim 1, wherein the anchor is radially collapsible for endoscopic insertion.

11. The intraluminal implant of claim 1, wherein the waves of the wave-shaped anchoring elements do not overlap axially.

12. A method for anchoring a flexible, elongated sleeve within a natural bodily lumen, the method comprising:

providing an anchor fixed to a proximal end of the flexible, elongated sleeve, the sleeve extending distally into the natural bodily lumen, the anchor comprising a plurality of wave-shaped anchoring elements, at least one of the plurality of anchoring elements comprising at least one external barb;

providing a radially-outward securing force from the anchor acting upon the natural bodily lumen; and

piercing muscular tissue of the natural bodily lumen with at least one external barb of the plurality of anchoring elements, the radially outward securing force driving the at least one barb into the muscular tissue.

13. The method of claim 12, further comprising inhibiting movement in either direction along the natural bodily lumen using the at least one external barb.

14. The method of claim 12, further comprising at least partially radially collapsing the anchor for insertion of the anchor into the natural bodily lumen.

15. The method of claim 12, further comprising at least partially radially collapsing at least a portion of the anchor for removal of the anchor from the natural bodily lumen.

16. The method of claim 12, wherein the anchor comprises two of the wave-shaped anchoring elements.

17. The method of claim 12, wherein the anchor comprises three of the wave-shaped anchoring elements.

18. The method of claim 17, wherein at least one external barb extends from a central anchoring element and the central anchoring element is stiffer than two end anchoring elements.

19. The method of claim 12, wherein the sleeve is floppy.

20. The method of claim 12, wherein the external barb is a bi-directional barb, comprising a first barb segment configured to oppose proximal movement and a second barb segment configured to oppose distal movement.

21. The method of claim 12, comprising anchoring the sleeve in the proximal duodenum and extending the sleeve distally within the intestine.

22. The method of claim 12, wherein the sleeve is thin-walled, collapsing upon itself.

23. The method of claim 12, wherein the anchor is coupled to the sleeve between overlapping layers of the sleeve.

24. The method of claim 12, wherein the waves of the wave-shaped anchoring elements do not overlap axially.