METHODS FOR CONTROLLING THE INTERNAL CIRCUMFERENCE OF AN ANATOMIC ORIFICE OR LUMEN

• US 20080109076A1
• Filed: 01/11/2008
• Published: 05/08/2008
• 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, Cartledge, Richard
• Granted Patent: US 8,673,001 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 securing a prosthetic annular ring to a patient'"'"'s heart comprising the steps of:

providing the prosthetic annular ring folded inside a catheter for delivery to the patient'"'"'s heart;

inserting the catheter through an anatomic passageway into a native recipient anatomic site of the patient'"'"'s heart;

expelling the prosthetic annular ring from the catheter;

securing the prosthetic annular ring to adjacent tissue, whereby said securing step includes application of external force so as to allow the prosthetic annular ring to attach to the adjacent tissue using a mechanical tissue interface system, thereby holding the prosthetic annular ring in place; and

removing the catheter from the anatomic passageway.

2. The method of claim 1, wherein said application of external force engages retention barbs into the adjacent tissue.

3. The method of claim 1, wherein said step of expelling comprises use of implant support arms that expand to deploy said folded annular ring to a radial dimension.

4. The method of claim 1, wherein said annular ring is expandable radially to anchor the heart valve at an implantation position.

5. The method of claim 1, wherein the annular ring and the mechanical tissue interface system are integrated into a one-piece design.

6. A method of implanting a percutaneous heart valve annulus, comprising the steps of:

folding said percutaneous heart valve annulus into a collapsed position;

inserting a catheter into a patient and guiding a distal end of said catheter to a position adjacent an implantation position in a patient'"'"'s heart;

inserting said folded heart valve annulus into said catheter and steering said folded heart valve annulus to said distal end of said catheter using a guiding device;

guiding said folded heart valve annulus beyond said distal end of said catheter so as to cause said heart valve annulus to unfold to a stable unfolded position;

guiding the heart valve annulus to the implantation position;

securing the prosthetic annular ring to adjacent tissue, whereby said securing step includes application of external force so as to allow the heart valve annulus to attach to the adjacent tissue using a mechanical tissue interface system; and

removing the guiding device and the catheter.

7. The method of claim 6, wherein said application of external force engages retention barbs into the adjacent tissue.

8. The method of claim 6, wherein the heart valve annulus is unfolded using implant support arms that expand to deploy said folded annular ring to a radial dimension.

9. The method of claim 6, wherein said heart valve annulus is expandable radially to anchor the heart valve annulus at the implantation position.

10. The method of claim 6, wherein the heart valve annulus and the mechanical tissue interface system are integrated into a one-piece design.

11. A prosthetic annulus delivery system comprising:

a foldable annular ring;

an expansion member removably connected to said foldable annular ring,

a catheter adapted to receive said foldable annular ring and said expansion member, wherein said expansion member is adapted to unfold said annular ring expulsion from said catheter; and

a mechanical tissue interface system, wherein said foldable annular ring is adapted to be secured to tissue adjacent said foldable annular ring when said foldable annular ring is unfolded and wherein said mechanical tissue interface system is configured to respond to an applied force to adhere to the adjacent tissue.

12. The system of claim 11, wherein said annular ring is adapted to fit in a mitral valve opening of a heart.

13. The system of claim 11, wherein said annular ring is adapted to fit in an aortic valve opening of a heart.

14. The system of claim 11, wherein said annular ring is adapted to fit in a pulmonary valve opening of a heart.

15. The system of claim 11, wherein said annular ring is adapted to fit in a tricuspid valve opening of a heart.