Atraumatic gastrointestinal anchor

• US 20060064120A1
• Filed: 09/16/2005
• Published: 03/23/2006
• Est. Priority Date: 09/17/2004
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Meade, John C., Levine, Andy H.
• Granted Patent: US 7,815,591 B2
• 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 anchor comprising:

an elongated anchor adapted for implanting within a natural bodily lumen, a central axis of the elongated anchor adapted for alignment with the natural bodily lumen, the elongated anchor including;

a primary anchoring region adapted to expand against the lumen; and

a secondary anchoring region disposed at either side of the primary anchoring region also adapted to expand against the lumen, the primary anchoring region expanding to a greater extent than the outer ends of the secondary anchoring regions.

2. The intraluminal anchor of claim 1 wherein the elongated anchor comprises a plurality of anchoring elements, at least one of the anchoring elements relating to the primary anchoring region and at least two other of the anchoring elements relating to the secondary anchoring regions.

3. The intraluminal anchor of claim 2, wherein the anchoring element relating to the primary anchoring region and the least two other of the anchoring elements relating to the secondary anchoring regions comprise different materials.

4. The intraluminal anchor of claim 2, wherein the anchoring element relating to the primary anchoring region and the least two other of the anchoring elements relating to the secondary anchoring regions comprise substantially the same material having a different thickness.

5. The intraluminal anchor of claim 2, wherein at least one of the plurality of anchoring elements is formed from an elongated wire.

6. The intraluminal anchor of claim 2, wherein at least one of the plurality of anchoring elements is a wave-shaped element.

7. The intraluminal anchor of claim 2, wherein at least one of the plurality of anchoring elements comprises at least one external barb adapted to penetrate tissue of the natural bodily lumen, the respective anchoring element expanding against the lumen and adapted to hold the barb within the tissue.

8. The intraluminal anchor of claim 7, wherein the external barb is a bi-directional barb, comprising a first barb segment adapted to oppose proximal movement and a second barb segment adapted to oppose distal movement.

9. The intraluminal anchor of claim 2, further comprising at least one joining member coupled between at least two of the plurality of anchoring elements.

10. The intraluminal anchor of claim 2, wherein at least one of the plurality of anchoring elements is coupled to a proximal end of an elongated tube, the tube adapted to extend distally within the natural bodily lumen.

11. The intraluminal anchor of claim 10, wherein the elongated tube is adapted to be anchored in the proximal duodenum, the tube extending distally within the intestine.

12. The intraluminal anchor of claim 10, wherein the elongated tube is thin-walled, collapsing upon itself.

13. The intraluminal anchor of claim 1, further comprising at least one external barb positioned at the primary anchoring region and adapted to penetrate tissue of the natural bodily lumen, the expanding against the lumen adapted to hold the barb within the tissue.

14. The intraluminal anchor of claim 13, wherein the external barb is a bi-directional barb, comprising a first barb segment adapted to oppose proximal movement and a second barb segment adapted to oppose distal movement.

15. The intraluminal anchor of claim 1, further comprising an elongated tube coupled at its proximal end to the elongated anchor, the tube adapted to extend distally within the natural bodily lumen.

16. The intraluminal anchor of claim 15, wherein the elongated tube is adapted to be anchored in the proximal duodenum, the tube extending distally within the intestine.

17. The intraluminal anchor of claim 15, wherein the elongated tube is thin-walled, collapsing upon itself.

18. The intraluminal anchor of claim 15, wherein the elongated anchoring element is coupled to the tube between overlapping layers of the tube.

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

20. The intraluminal anchor of claim 1, wherein the elongated anchor is formed from a homogeneous hollow tube having a tube wall of differing thickness along its length, the tube wall defining apertures adapted to allow radial variation of the tube.

21. The intraluminal anchor of claim 1, wherein the primary and secondary anchoring regions comprise different spring rates.

22. The intraluminal anchor of claim 1, wherein the primary anchoring region is central.

23. A method for anchoring within a natural bodily lumen comprising:

providing a radially-outward securing force acting upon a first region of the natural bodily lumen;

providing a radially-outward transitional force acting upon either side of the first region of the natural bodily lumen; and

allowing continued function of the natural bodily lumen, radially-outward transitional force being adapted to mitigate damage to the natural bodily lumen.

24. The method of claim 23, wherein a first anchoring elements providing the radially-outward securing force and a second anchoring element provides the radially-outward transitional force.

25. The method of claim 23, further comprising piercing interior walls of the natural bodily lumen with at least one external barb, the radially outward securing force driving the at least one barb into the interior wall.

26. The method of claim 25, further comprising inhibiting movement in either direction along the natural bodily lumen using the at least one barb.

27. The method of claim 23, further comprising at least partially radially collapsing the elongated anchoring element for insertion of the intraluminal anchor into the natural bodily lumen.

28. The method of claim 23, further comprising at least partially radially collapsing at least a portion of the elongated anchoring element for removal of the intraluminal anchor from the natural bodily lumen.

29. An intraluminal anchor comprising:

means for providing a radially-outward force upon a first region of the natural bodily lumen; and

means for providing a different radially-outward force upon a distal region of the natural bodily lumen, while allowing continued function of the natural bodily lumen, wherein at least one of the radially-outward forces is a securing force adapted to anchor within the natural bodily lumen and the other radially-outward force is a transition force adapted to mitigate damage to the natural bodily lumen.