Gastrointestinal anchor compliance

• US 7,976,488 B2
• Filed: 06/08/2005
• Issued: 07/12/2011
• Est. Priority Date: 06/08/2005
• Status: Active Grant

• Current Assignee: Gidynamics, Inc.
• Original Assignee: GI Dynamics Incorporated
• Inventors: Melanson, David A., Levine, Andy H.
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): SU, SUSAN SHAN
• Application Number:
  US11/147,992
• Publication Number:
  US 20070005147A1
• Time in Patent Office: 2,225 Days
• Field of Search: 604/8, 623/23.64, 623/23.65, 623/23.7
• US Class Current: 604/8
• 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 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 5/0076 preventing normal digestion, e.g. Bariatric or gastric sleeves

Abstract

A collapsible gastrointestinal anchor can be characterized in various embodiments by a radial force of about 0.1 Newtons (N) or greater at a compressed diameter of 25 millimeters (mm); by an average spring rate of about 13 Newtons/meter (N/m) or greater in a range of motion between a relaxed diameter and a compressive elastic deformation diameter; or by a radial force over the range of motion of about 0.1 N or greater. Typically, the anchor can be adapted to be retained within a subject'"'"'s intestine, more typically in the duodenum, or particularly in the duodenal bulb just distal to the pylorus.

A gastrointestinal implant device includes the collapsible gastrointestinal anchor and a floppy sleeve. The sleeve is open at both ends and adapted to extend into a subject'"'"'s intestine, the anchor being coupled to a proximal portion of the sleeve.

Also include are methods of implanting the gastrointestinal implant device in a subject, and methods of treating a subject for disease.

The disclosed gastrointestinal invention leads to an improved ability to secure anchors and devices in the gastrointestinal tract while tending to minimize migration.

Claims

1. A gastrointestinal implant device comprising:

a flexible sleeve, open at both ends and adapted to extend into a subject'"'"'s intestine; and

a collapsible gastrointestinal anchor, coupled to a proximal portion of the sleeve and characterized by a radial force of between about 0.3 Newtons (N) and about 1.5 N at a compressed diameter of 25 millimeters (mm);

the collapsible gastrointestinal anchor being further characterized by a radial force of between about 0.1 N and about 1.5 N over a range of motion of at least about 20 mm, the range of motion being within a diameter range defined by a relaxed diameter and a compressive elastic deformation diameter, the diameter range including 25 mm.

2. The gastrointestinal implant device of claim 1, the radial force at 25 mm being measured while unloading the anchor from a compressed state.

3. The gastrointestinal implant device of claim 1, characterized by a relaxed diameter of about 40 mm or greater.

4. The gastrointestinal implant device of claim 1, characterized by a relaxed diameter of between about 45 mm and about 65 mm.

5. The gastrointestinal implant device of claim 1, the radial force being between about 0.2 N and about 1.5 N over the range of motion.

6. The gastrointestinal implant device of claim 1, further comprising barbs.

7. The gastrointestinal implant device of claim 1, characterized by a compressive elastic deformation diameter of about 12 mm or less.

8. The gastrointestinal implant device of claim 1, the anchor being made of Nitinol wire.

9. The gastrointestinal implant device of claim 1, the range of motion being about 30 mm or greater.

10. The gastrointestinal implant device of claim 1, wherein the radial force at 25 mm is between about 0.4 N and about 1.5 N.

11. The gastrointestinal implant device of claim 1, wherein the radial force at 25 mm is between about 0.5 N and about 1.5 N.