Two-way adjustable implant

• US 20070185374A1
• Filed: 01/16/2007
• Published: 08/09/2007
• Est. Priority Date: 01/17/2006
• Status: Abandoned Application

• Current Assignee: Ellipse Technologies, Inc. (Nuvasive Incorporated)
• Original Assignee: Ellipse Technologies, Inc. (Nuvasive Incorporated)
• Inventors: Lenker, Jay, Kick, George
• Application Number:
  US11/654,068
• Publication Number:
  US 20070185374A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like

Abstract

An adjustable implant configured to be implanted within or at least partially around an outer surface of a stomach or esophagus is described. The adjustable implant includes a ratchet. The implant further includes an elongate band comprising a shape-memory material, wherein a first end and a second end of the elongate band are configured to couple to the ratchet, such that the band and the ratchet form an assembly having a loop configuration. Activation of the shape-memory material adjusts the band from a first length to a second length as the ratchet permits movement in a first direction of the first end relative to the second end, changing a circumference of the loop configuration.

Claims

1. An adjustable implant, configured to be implanted within or at least partially around an outer surface of a stomach or esophagus, comprising:

a ratchet; and

an elongate band comprising a shape-memory material, wherein a first end and a second end of the elongate band are configured to couple to the ratchet, such that the band and the ratchet form an assembly having a loop configuration;

wherein activation of the shape-memory material adjusts the band from a first length to a second length as the ratchet permits movement in a first direction of the first end relative to the second end, changing a circumference of the loop configuration.

2. The adjustable implant of claim 1, wherein the elongate band further comprises a pawl spring that comprises the shape-memory material.

3. The adjustable implant of claim 1, wherein the ratchet permits movement in a second direction of the first end relative to the second end, changing the circumference of the loop.

4. The adjustable implant of claim 1, wherein the ratchet comprises a pawl and a detent.

5. The adjustable implant of claim 1, the assembly being configured to be formed as a loop within or around a portion of the stomach or esophagus, and wherein the elongate band is configured to change a dimension of a lumen of the portion of the stomach or esophagus by adjusting the circumference of the loop.

6. The adjustable implant of claim 1, the assembly being configured to encircle at least partially a portion of the stomach.

7. The adjustable implant of claim 1, wherein the assembly is configured to decrease the circumference of the loop.

8. The adjustable implant of claim 1,

wherein the ratchet further comprises a plurality of detents;

wherein the elongate band comprises a pawl at the second end of the elongate band;

and wherein the elongate band is configured to decrease or increase the circumference of the loop by drawing a detent past the pawl when the shape-memory material is activated.

9. The adjustable implant of claim 1, wherein the elongate band is configured to be implanted around a portion of the stomach to form a gastric pouch, and wherein the elongate band is configured to change a size of a lumen in the gastric pouch by adjusting, a circumference of the loop.

10. The adjustable implant of claim 1, wherein the elongate band comprises a polymer.

11. The adjustable implant of claim 1, wherein the shape-memory material comprises at least one of a metal, a metal alloy, a nickel titanium alloy, and a shape-memory polymer.

12. The adjustable implant of claim 1, wherein the shape-memory material comprises at least one of Fe—

C, Fe—

Pd, Fe—

Mn—

Si, Co—

Mn, Fe—

Co—

Ni—

Ti, Ni—

Mn—

Ga, Ni₂MnGa, and Co—

Ni—

Al.

13. The adjustable implant of claim 1, wherein the elongate band is configured to detach into a first band portion and a second band portion.

14. The adjustable implant of claim 1, further comprising a hydrophilic material substantially coating at least a portion of the implant.

15. The adjustable implant of claim 14, wherein the hydrophilic material comprises at least one of polyethylene glycol and Poly 2-Hydroxyethylmethacrylate.

16. The adjustable implant of claim 14, wherein an external layer having a varying thickness comprises the hydrophilic material.

17. The implantable device of claim 1, further comprising a restraint that at least partially encloses at least a portion of the ratchet and is configured to prevent or reduce at least one of (1) the first end of the elongate band from uncoupling from the ratchet, and (2) encroachment by tissue into a region at the first end.

18. The adjustable implant of claim 1, further comprising a spring return mechanism coupled to the elongate band.

19. An adjustable implant configured to be implanted around an outer surface of a stomach or esophagus, comprising:

encircling means for at least partially surrounding the stomach or esophagus, the encircling means comprising a shape-memory material; and

ratchet means for permitting movement in a first direction of a first end of the encircling means relative to a second end of the encircling means;

wherein activation of the shape-memory material adjusts the encircling means from a first length to a second length as the ratchet means permits the movement of the first end relative to the second end, changing a circumference of the encircling means.

20. The adjustable implant of claim 19, further comprising an activation means configured to provide an activation energy to the shape-memory material.

21. A method, for treating obesity, the method comprising the steps of:

placing an adjustable implant within or around a patient'"'"'s stomach or esophagus, the adjustable implant comprising;

a ratchet; and

an elongate band comprising a shape-memory material, wherein a first end and a second end of the elongate band are configured to couple to the ratchet, such that the band and the ratchet form an assembly having a loop configuration;

wherein activation of the shape-memory material adjusts the band from a first length to a second length as the ratchet permits movement in a first direction of the first end relative to the second end, changing a circumference of the loop configuration;

applying an activation energy to the shape-memory material; and

transforming the shape-memory material from a first configuration to a second configuration, thereby changing the circumference of the loop configuration.

22. The method of claim 21, wherein the ratchet comprises a plurality of serially arranged detents, and changing the circumference of the loop configuration comprises moving the first end of the elongate band from a first position, at one of the plurality of detents, to a second position, at another of the plurality of detents.

23. The method of claim 21, wherein the implant further comprises a spring configured to expand the circumference of the loop configuration to a maximum circumference.

24. The method of claim 21, wherein the implant further comprises a hydrophilic coating that substantially coats at least a portion of the implant.

25. The method of claim 21, wherein the implant comprises a pre-implantation shape and a post-implantation shape, further comprising:

laparoscopically inserting the implant in the pre-implantation shape into the patient, so as to facilitate having the implant assume the post-implantation shape around the stomach or esophagus.

26. The method of claim 21, wherein the implant comprises a pre-implantation shape and a post-implantation shape, further comprising:

endoscopically inserting the implant in the pre-implantation shape into the patient, so as to facilitate having the implant assume the post-implantation shape within the stomach or esophagus.

27. The method of claim 21, wherein the shape-memory material comprises. at least one of a metal, a metal alloy, a nickel titanium alloy, and a shape-memory polymer.

28. The method of claim 27, wherein the shape-memory material comprises at least one of Fe—

C, Fe—

Pd, Fe—

Mn—

Si, Co—

Mn, Fe—

Co—

Ni—

Ti, Ni—

Mn—

Ga, Ni₂MnGa, and Co—

Ni—

Al.

29. The method of claim 21, wherein the activation energy comprises at least one of magnetic resonance imaging energy, high-intensity focused ultrasound energy, radio frequency energy, x-ray energy, microwave energy, light energy, electric field energy, magnetic field energy, inductive heating, and conductive heating.