Methods and apparatus for anchoring within the gastrointestinal tract

• US 8,628,583 B2
• Filed: 09/14/2012
• Issued: 01/14/2014
• Est. Priority Date: 12/09/2003
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Meade, John C., Levine, Andy H., Melanson, David A., Cvinar, John F.
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/618,036
• Publication Number:
  US 20130012862A1
• Time in Patent Office: 487 Days
• Field of Search: 623/23.64, 623/23.65, 604/8
• US Class Current: 623/23.64
• 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 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• 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: 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 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics

Abstract

The present invention relates to an anchor configured for minimally-invasive implantation and sized to remain securely positioned within at least a portion of the gastrointestinal tract of an animal. The anchor includes a radial spring formed from an elongated resilient member shaped into an annular wave pattern about a central axis. The anchor defines a central lumen and provides an outward radial force, while allowing for substantial flexure about its perimeter. The anchor is generally removable, but can include fasteners, such as barbs, to further secure it to the surrounding anatomy. In some embodiments, the anchor includes a connector coupling a fixed portion to a removable portion. Further, the anchor can be used to secure a medical device within the body, such as a flexible sleeve within the intestine.

Claims

1. A method of treatment comprising the steps of:

extending one end of an unsupported, flexible sleeve into the intestine of an animal body;

attaching a terminal proximal end of the sleeve within the intestine of the animal using an anchor that includes a wave anchor in the duodenal bulb, the wave anchor forming a seal at the terminal proximal end of the sleeve, the seal being between the terminal proximal end of the sleeve and the intestine; and

channeling chyme from the stomach into the intestine through the sleeve.

2. The method of claim 1 wherein the wave anchor has an axial length within a range of about 25 millimeters to about 50 millimeters.

3. The method of claim 1 wherein the wave anchor accommodates a diameter of an adult human'"'"'s intestine of about 45 millimeters.

4. The method of claim 1 wherein the wave anchor has a single wave in a single revolution.

5. The method of claim 4 wherein the single wave includes an elongated resilient member formed about a central axis, the wave anchor having a first end and a second end and defining a central lumen therebetween, the elongated resilient member defining an oscillating pattern about the central axis alternating between the first and second ends.

6. The method of claim 5 wherein the oscillating pattern has at least four oscillations.

7. The method of claim 5 wherein the elongated resilient member comprises a material selected from the group consisting of:

metals, alloys, plastics, and combinations thereof.

8. The method of claim 5 wherein the elongated resilient member comprises a shape memory alloy.

9. The method of claim 8, wherein the shape memory alloy is a Nickel Titanium alloy.

10. The method of claim 5 wherein the elongated resilient member includes a plurality of strands.

11. The method of claim 10 wherein some of the plurality of strands have different physical properties.

12. The method of claim 5 wherein the elongated resilient member comprises a first length having an associated physical property and a second length having a different associated physical property.

13. The method of claim 12 wherein the physical property is resiliency.

14. The method of claim 12 wherein the physical property is thickness.

15. The method of claim 12 wherein the physical property is cross sectional profile.

16. The method of claim 1 wherein the wave anchor defines a central lumen diameter that is variable between a relaxed state and a compressed state, the ends being separated by an axial length, wherein the ratio of the implanted axial length to diameter is at least about one.

17. The method of claim 16 wherein the relaxed diameter is about 45 millimeters.

18. The method of claim 1 wherein attaching includes engaging the intestine with protrusions extending from the wave anchor.

19. The method of claim 18 wherein the protrusions include a plurality of barbs, and wherein each of the plurality of barbs comprises an elongated member, attached at one end to the wave anchor, the other end extending generally outward from the central axis, the barb sized to engage muscular tissue of the surrounding intestine.