Methods for controlling the internal circumference of an anatomic orifice or lumen

• US 20040249453A1
• Filed: 08/29/2003
• Published: 12/09/2004
• Est. Priority Date: 08/29/2002
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Mitralsolutions, Inc.
• Inventors: Lee, Leonard Y., Cartledge, Richard G.
• Granted Patent: US 7,455,690 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• 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 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2002/30537 adjustable
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 5/0079 Pyloric or esophageal obstructions

Abstract

A method for controlling the circumference of internal anatomic passages corrects physiologic dysfunctions resulting from a structural orifice or lumen which is either too large or too small. Implants are disclosed which employ various means for adjusting and maintaining the size of an orifice to which they are attached. Systems permit the implants to be implanted using minimally invasive procedures and permit final adjustments to the circumference of the implants after the resumption of normal flow of anatomic fluids in situ. Methods are disclosed for using the implants to treat heart valve abnormalities, gastroesophageal abnormalities, anal incontinence, and the like.

Claims

1. A method for controlling the internal circumference of an anatomic orifice or lumen, comprising the steps of:

stopping the flow of physiological fluids through an anatomic orifice or lumen;

creating an incision in the body of a patient to provide access to a desired anatomic orifice or lumen;

securing an annular ring to the tissue around said anatomic orifice or lumen;

closing said incision;

resuming the flow of physiological fluids through said anatomic orifice or lumen; and

adjusting the circumference of said annular ring to control the internal circumference of said anatomic orifice or lumen, using the flow of physiological fluids through said anatomic orifice or lumen as a factor in adjusting said circumference.

2. The method of claim 1, wherein said anatomic orifice or lumen is a heart valve.

3. The method of claim 1,

wherein said annular ring comprises teeth on at least a portion thereof,

wherein said annular ring has a gear operatively associated therewith, and

wherein said gear and said teeth are arranged such that rotating said gear effects movement of a first end of said annular ring with respect to a second end of said annular ring to adjust the circumference thereof;

and

wherein said step of adjusting the circumference of said annular ring to control the internal circumference of said anatomic orifice or lumen comprises the step of rotating said gear.

4. The method of claim 3, wherein said step of rotating said gear comprises the step of rotating said gear from a location outside said closed incision.

5. The method of claim 4, wherein said step of rotating said gear from a location outside said closed incision comprises the step of rotating said gear with an elongated tool having a first end engaging said gear and a second end extending outside said closed incision.

6. The method of claim 5, further comprising the step, subsequent to said step of adjusting the circumference of said annular ring, of uncoupling said elongated tool from said gear and withdrawing said elongated tool, leaving said annular ring in place.

7. The method of claim 4, wherein said step of rotating said gear from a location outside said closed incision comprises the step of actuating a microelectric motor in driving engagement with said gear from outside said closed incision.

8. A method for controlling the internal circumference of an anatomic orifice or lumen, comprising the steps of:

stopping the flow of physiological fluids through an anatomic orifice or lumen;

securing an annular ring to the tissue around said anatomic orifice or lumen;

resuming the flow of physiological fluids through said anatomic orifice or lumen; and

adjusting the circumference of said annular ring to control the internal circumference of said anatomic orifice or lumen, using the flow of physiological fluids through said anatomic orifice or lumen as a factor in adjusting said circumference.

9. The method of claim 8, wherein said anatomic orifice or lumen is a heart valve.

10. The method of claim 8,

wherein said annular ring comprises teeth on at least a portion thereof,

wherein said annular ring has a gear operatively associated therewith, and

wherein said gear and said teeth are arranged such that rotating said gear effects movement of a first end of said annular ring with respect to a second end of said annular ring to adjust the circumference thereof;

and

wherein said step of adjusting the circumference of said annular ring to control the internal circumference of said anatomic orifice or lumen comprises the step of rotating said gear.

11. The method of claim 10, wherein said step of rotating said gear comprises the step of rotating said gear with an elongated tool having a first end engaging said gear and a second end extending to a location outside said patient.

12. The method of claim 11, further comprising the step, subsequent to said step of adjusting the circumference of said annular ring, of uncoupling said elongated tool from said gear and withdrawing said elongated tool, leaving said annular ring in place.

13. The method of claim 10, wherein said step of rotating said gear from a location outside said closed incision comprises the step of actuating a microelectric motor in driving engagement with said gear.

14. A method for controlling the internal circumference of an anatomic orifice or lumen, comprising the steps of:

creating an incision in the body of a patient to provide access to a desired anatomic orifice or lumen;

securing an annular ring to the tissue around said anatomic orifice or lumen;

closing said incision;

adjusting the circumference of said annular ring to control the internal circumference of said anatomic orifice or lumen.

15. The method of claim 14, wherein said anatomic orifice or lumen is a heart valve.

16. The method of claim 14,

wherein said annular ring comprises teeth on at least a portion thereof,

wherein said annular ring has a gear operatively associated therewith, and

wherein said gear and said teeth are arranged such that rotating said gear effects movement of a first end of said annular ring with respect to a second end of said annular ring to adjust the circumference thereof;

and

wherein said step of adjusting the circumference of said annular ring to control the internal circumference of said anatomic orifice or lumen comprises the step of rotating said gear.

17. The method of claim 16, wherein said step of rotating said gear comprises the step of rotating said gear from a location outside said closed incision.

18. The method of claim 17, wherein said step of rotating said gear from a location outside said closed incision comprises the step of rotating said gear with an elongated tool having a first end engaging said gear and a second end extending outside said closed incision.

19. The method of claim 18, further comprising the step, subsequent to said step of adjusting the circumference of said annular ring, of uncoupling said elongated tool from said gear and withdrawing said elongated tool, leaving said annular ring in place.

20. The method of claim 17, wherein said step of rotating said gear from a location outside said closed incision comprises the step of actuating a microelectric motor in driving engagement with said gear from outside said closed incision.

21. A method for controlling the internal circumference of an anatomic orifice or lumen, comprising the steps of:

positioning an annular implant onto a positioning apparatus in a collapsed condition;

advancing a forward end of said positioning apparatus through natural or surgically-created openings in the body of a patient until said forward end of said positioning apparatus lies adjacent an anatomic orifice or lumen whose circumference is desired to be adjusted;

manipulating said positioning apparatus to open said annular implant into an expanded condition;

maneuvering said positioning apparatus until said expanded annular implant is positioned against the tissues surrounding said anatomic orifice or lumen;

fastening said expanded annular implant to the tissues surrounding said anatomic orifice or lumen; and

adjusting the circumference of said annular implant to control the circumference of said anatomic orifice or lumen.

22. The method of claim 21, wherein said annular implant comprises a plurality of barbs projecting therefrom, and

wherein said step of fastening said expanded annular implant to the tissues surrounding said anatomic orifice or lumen comprises the step of pressing said barbs into the tissues surrounding said anatomic orifice or lumen.