DEVICES AND METHODS FOR TREATING GASTROINTESTINAL AND METABOLIC DISORDERS

• US 20120041465A1
• Filed: 10/25/2011
• Published: 02/16/2012
• Est. Priority Date: 04/30/2009
• Status: Abandoned Application

• Current Assignee: Svip 7 LLC
• Original Assignee: Svip 7 LLC
• Inventors: SHALON, Tidhar
• Application Number:
  US13/280,418
• Publication Number:
  US 20120041465A1
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• 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 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 2017/00818 Treatment of the gastro-intestinal system
• CPC Class Codes: A61B 2017/0417 T-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 hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions

Abstract

A device for treating gastrointestinal and metabolic disorders is described. The device includes a device body which is present in the GI tract tissue of a subject and functions in treating gastrointestinal and metabolic disorders such as obesity, diabetes and reflux disease.

Claims

1. A device for treating a gastrointestinal disorder of a subject comprising a tether having an end portion adapted for anchoring to a tissue of a GI tract and at least one device body attached along a length of said tether, said at least one device body being a normally-open, elastically-compressible structure capable of:

(i) at least partially occluding a lumen of said GI tract in said normally-open state; and

(ii) passing through said GI tract following detachment of said tether from said tissue of said GI tract.

2. The device of claim 1, wherein said at least one device body is configured for at least partially blocking an antral, pyloric and/or duodenal region of said GI tract and further wherein said end portion is anchorable to a tissue of a stomach and a length of said tether is selected for positioning said at least one device body 7 cm or less from said pylorus.

3. The device of claim 1, wherein said device body is shaped as a hollow sleeve, open cone or umbrella.

4. The device of claim 3, wherein said hollow sleeve, open cone or umbrella comprises a web to resist inversion.

5. The device of claim 1, wherein said device body is a disk having a wall thickness of 1 mm or less.

6. The device of claim 1, wherein said at least one device body has a maximum displaced volume of 1 cubic centimeter.

7. The device of claim 2, wherein at least a portion of said tether can reversibly increase in length by least 25%.

8. The device of claim 2, wherein said at least one device body is capable of moving between a stomach and a duodenum when said tether is anchored to said tissue of said stomach.

9. The device of claim 1, wherein said at least one device body has a maximal cross sectional area of 10 square centimeters.

10. The device of claim 1, wherein said at least one device body is configured to collapse to its minimal contained volume under a force of less than 1 Newton.

11. The device of claim 1, wherein said at least one device body can elastically deform from a contained volume of zero to a contained volume of up to 30 cm³.

12. The device of claim 1, wherein all portions of the device pass through the GI tract following detachment of the device from said tissue of said GI tract.

16. A method of modifying an eating behavior of a subject comprising:

(a) delivering the device of claim 1 to the stomach of the subject; and

(b) delivering said end portion of said tether through tissue of said stomach such that said end portion of said tether is positioned at a predetermined distance from a tissue landmark thereby modifying an eating behavior of the subject.

17. The method of claim 16, wherein (b) is effected such that an opening of said device body is oriented facing the oral direction during gastric emptying.

18. The method of claim 16, wherein (a) is effected by sucking tissue into a vacuum chamber in a direction normal to the axis of movement of a tissue penetrating element.

19. The method of claim 16, wherein said delivering said end portion of said tether through tissue of said stomach is effected using a distance marker for determining a tissue site for penetration relative to a tissue landmark.

20. The method of claim 19, wherein said tissue landmark is a pylorus.

13. A system for treating a gastrointestinal disorder comprising:

(a) a device including at least one device body attached along a length of a tether having an end portion anchorable to a tissue; and

(b) a delivery apparatus including;

(i) a tissue penetrating element for delivering said end portion of said tether through a tissue of a gastrointestinal wall; and

(ii) a distance marker for determining a tissue site for delivering said end portion of said tether through said tissue such that said end portion of said tether is positioned at a predetermined distance from a tissue landmark.

14. The system of claim 13, wherein said delivery apparatus includes a vacuum chamber for suctioning said tissue in a direction normal to an axis of movement of said tissue penetrating element.

15. The system of claim 13 wherein said tissue penetrating element includes a pushrod positioned within a lumen thereof and further wherein said delivery apparatus includes a handle configured for sequentially displacing said tissue penetrating element and said pushrod in one operator motion.