Gastrointestinal anchor compliance

• US 8,425,451 B2
• Filed: 06/02/2011
• Issued: 04/23/2013
• Est. Priority Date: 06/08/2005
• Status: Active Grant

• Current Assignee: GI Dynamics Incorporated
• Original Assignee: GI Dynamics Incorporated
• Inventors: Levine, Andy H., Melanson, David A.
• Primary Examiner(s): SU, SUSAN SHAN
• Application Number:
  US13/151,983
• Publication Number:
  US 20110301523A1
• Time in Patent Office: 691 Days
• Field of Search: 623/23.64, 623/23.65, 623/23.7, 604/8
• 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 an average spring rate of between about 13 Newtons/meter (N/m) and about 35 N/m in a range of motion of about 20 mm or greater, the range of motion being within a diameter range defined by a relaxed diameter and a compressive elastic deformation diameter.

2. The gastrointestinal implant device of claim 1, the spring rate being the spring rate while the anchor is unloaded 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, the average value of the spring rate being between about 15 N/m and about 35 N/m.

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

6. A method of treating a subject, comprising the steps of:

securing a gastrointestinal implant device within a subject'"'"'s intestine, the device including a flexible sleeve, open at both ends and adapted to extend into the subject'"'"'s intestine; and

a collapsible gastrointestinal anchor, coupled to a proximal portion of the sleeve and characterized by an average spring rate of between about 13 Newtons/meter (N/m) and about 35 N/m in a range of motion of about 20 mm or greater, the range of motion being within a diameter range defined by a relaxed diameter and a compressive elastic deformation diameter; and

extending the distal end of the sleeve into the subject'"'"'s intestine.

7. The method of claim 6, the anchor being characterized by a relaxed diameter of about 40 mm or greater.

8. The method of claim 6, the average value of the spring rate being between about 15 N/m and about 35 N/m.

9. The method of claim 6, the range of motion being about 30 mm or greater.

10. A collapsible gastrointestinal anchor comprising a wave spring having a plurality of barbs extending therefrom, the wave spring being characterized by:

a relaxed diameter of about 40 millimeters (mm) or greater;

a compressive elastic deformation diameter of about 12 mm or less;

an average spring rate of between about 13 Newtons/meter (N/m) and about 35 N/m over a range of motion of about 20 mm or greater, the range of motion being within a diameter range defined by the relaxed diameter and the compressive elastic deformation diameter; and

a radial force under compression, the radial force being between about 0.1 Newtons (N) and about 1.5 N at a diameter of 25 mm, and the radial force being between about 0.1 N and about 1.5 N over the range of motion,

the spring rate and the radial force being the spring rate and the radial force while the spring is unloaded from a compressed state.

11. 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, the anchor comprising a wave spring having a plurality of barbs extending therefrom,

the wave spring being characterized by a relaxed diameter of about 40 millimeters (mm) or greater;

a compressive elastic deformation diameter of about 12 mm or less;

an average spring rate of between about 13 Newtons/meter (N/m) and about 35 N/m over a range of motion of about 20 mm or greater, the range of motion being within a diameter range defined by the relaxed diameter and the compressive elastic deformation diameter; and

a radial force under compression, the radial force being between about 0.1 Newtons (N) and about 1.5 N at a diameter of 25 mm, and the radial force being between about 0.1 N and about 1.5 N over the range of motion,

the spring rate and the radial forces being the spring rate and the radial forces while the spring is unloaded from a compressed state.

12. A method of treating a subject, comprising the steps of:

securing a gastrointestinal implant device within a subject'"'"'s intestine, the device including a flexible sleeve, the sleeve open at both ends and adapted to extend into the subject'"'"'s intestine, and a collapsible gastrointestinal anchor coupled to a proximal portion of the sleeve, the anchor comprising a wave spring having a plurality of barbs extending therefrom; and

extending the distal end of the sleeve into the subject'"'"'s intestine,

the wave spring being characterized by a relaxed diameter of about 40 millimeters (mm) or greater;

a compressive elastic deformation diameter of about 12 mm or less;

an average spring rate of between about 13 Newtons/meter (N/m) and about 35 N/m over a range of motion of about 20 mm or greater, the range of motion being within a diameter range defined by the relaxed diameter and the compressive elastic deformation diameter; and

a radial force under compression, the radial force being between about 0.1 Newtons (N) and about 1.5 N at a diameter of 25 mm, and the radial force being between about 0.1 N and about 1.5 N over the range of motion,

the spring rate and the radial forces being the spring rate and the radial forces while the spring is unloaded from a compressed state.