Implantation system for annuloplasty rings

• US 7,485,142 B2
• Filed: 06/21/2004
• Issued: 02/03/2009
• Est. Priority Date: 12/21/2001
• Status: Active Grant

• Current Assignee: QuickRing Medical Technologies Ltd.
• Original Assignee: Simcha Milo
• Inventors: Milo, Simcha
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/873,703
• Publication Number:
  US 20040236419A1
• Time in Patent Office: 1,688 Days
• Field of Search: 623/2.11, 623/2.38, 623/2.36, 623/2.39, 606/219, 606/228, 128/898
• US Class Current: 623/2.11
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61F 2/2448 D-shaped rings

Abstract

Methods for reconfiguring an atrioventricular heart valve that may use systems comprising a partial or complete annuloplasty rings proportioned to reconfigure a heart valve that has become in some way incompetent, a pair of trigonal sutures or implantable anchors, and a plurality of staples which may have pairs of legs that are sized and shaped for association with the ring at spaced locations along its length. These systems permit relative axial movement between the staples and the ring, whereby a patient'"'"'s heart valve can be reconfigured in a manner that does not deter subtle shifting of the native valve components. Shape-memory alloy material staples may have legs with free ends that interlock following implantation. Annuloplasty rings may be complete or partial and may be fenestrated. One alternative method routes a flexible wire, preferably of shape-memory material, through the bights of pre-implanted staples. Other alternative systems use linkers of shape-memory material having hooked ends to interengage with staples or other implanted supports which, following implantation, decrease in effective length and pull the staples or other supports toward one another so as to create desired curvature of the reconfigured valve. These linkers may be separate from the supports or may be integral with them and may have a variety of shapes and forms. Various of these systems may be implanted non-invasively using a delivery catheter.

Claims

1. A method of reconfiguring an atrioventricular heart valve without replacing the natural valve leaflets, which method comprises

providing an annuloplasty ring sized and shaped to have a desired configuration and formed with a plurality of openings along its length, and

implanting said ring upon the tissue surface at the mitral or tricuspid valve of a patient by implanting a plurality of staples in the patient'"'"'s heart tissue so as to spatially position said annuloplasty ring in a reconfiguration association along a portion of the native valve annulus, in association with one or more of the natural valve leaflets, with one leg of each said staple being disposed in only a portion of one of said plurality of said openings, while providing the tissue, in which said staples are implanted, with the ability to shift with respect to said ring and conform the annulus to said ring so the shape of the valve will steadily improve to an optimum configuration where its natural leaflets achieve better coaptation.

2. The method of claim 1 wherein said ring is secured directly to the heart tissue by sutures located at the trigons of the valve.

3. The method of claim 2 wherein said annuloplasty ring is a partial ring and said trigonal sutures are respectively ligated to the opposite ends of said partial ring.

4. The method of claim 3 wherein said staples are implanted in association with said partial ring in accordance with a pattern wherein the first staple is implanted near the midpoint of said partial ring and a pair of staples are next implanted at about the halfway points between said midpoint and the respective ends.

5. The method of claim 4 wherein the remainder of the staples are respectively positioned so as to be approximately equidistant between two already implanted staples or between an already implanted staple and said end of said partial ring.

6. The method of claim 1 wherein said staples are formed of a shape-memory material and said legs assume a secure angular orientation within the tissue following implantation.

7. The method of claim 1 wherein said staples have pairs of legs which have free pointed ends that form an interlocking orientation following implantation as a result being formed of shape-memory material.

8. The method of claim 1 wherein said annuloplasty ring is fenestrated, being formed with said openings in the form of elongated windows.

9. The method of claim 1 wherein said ring is a partial ring the ends of which are secured directly to the heart tissue by anchors implanted into the heart tissue.

10. A method of reconfiguring an atrioventricular heart valve without replacing the natural valve leaflets, which method comprises

providing an annuloplasty ring of a size and shape to at least partially encircle a mitral or tricuspid valve, which ring has a plurality of apertures spaced along its length, and

implanting said ring at the mitral or tricuspid valve of a patient generally along the native annulus in association with one or more of the natural valve leaflets by implanting a plurality of staples having pairs of legs in the patient'"'"'s heart tissue with one leg of each said staple protruding through one of said apertures so as to spatially position said annuloplasty ring in a reconfiguration association therewith, while providing the tissue, in which said staples are implanted, with the ability to conform the patient'"'"'s annulus as desired but also to shift axially with respect to said ring because each said staple leg fills only a portion of the area of said respective aperture so the shape of the valve will steadily improve to an optimum configuration where its natural leaflets achieve better coaptation.

11. The method of claim 10 wherein said staples are formed of a shape-memory material and said legs assume a secure angular orientation within the tissue following implantation.

12. The method of claim 10 wherein said staples have pairs of legs which have free ends that form an interlocking orientation.

13. The method of claim 12 wherein said interlocking occurs following implantation as a result of said staples being formed of shape-memory material.

14. The method of claim 10 wherein said annuloplasty ring is flat.

15. The method of claim 10 wherein said annuloplasty ring is frustoconical in shape.

16. The method of claim 10 wherein said annuloplasty ring is formed of a biocompatible metal alloy with said apertures shaped as elongated windows, and wherein said staples are implanted with one leg of each extending through one of said windows and with the other leg straddling the radially outer edge of said ring.

17. The method of claim 10 wherein said ring is a partial ring, ends of which are secured directly to the heart tissue by sutures or anchors located near the trigons of the valve.

18. The method of claim 17 wherein said staples are implanted in association with said partial ring in accordance with a pattern wherein the first staple is implanted near the midpoint of said partial ring and a pair of staples are next implanted at about the halfway points between said midpoint and the respective ends.

19. The method of claim 18 wherein the remainder of said staples are respectively positioned so as to be approximately equidistant between two of said already implanted staples or between one said already implanted staple and one said end of said partial ring.

20. The method of claim 17 wherein said ends of said partial ring are secured directly to the heart tissue by anchors implanted into the heart tissue.

21. The method of claim 17 wherein said partial ring has attachment ears with openings at said respective ends, through which openings said ends are secured to the valve tissue.

22. The method of claim 21 wherein each ear includes a pair of openings.

23. The method of claim 22 wherein each said pair of openings is in longitudinal alignment with the adjacent section of said ring.