Implantation system for annuloplasty rings

• US 8,123,801 B2
• Filed: 02/02/2009
• Issued: 02/28/2012
• Est. Priority Date: 12/21/2001
• Status: Active Grant

• Current Assignee: QuickRing Medical Technologies Ltd.
• Original Assignee: QuickRing Medical Technologies Ltd.
• Inventors: Milo, Simcha
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US12/364,414
• Publication Number:
  US 20090177277A1
• Time in Patent Office: 1,121 Days
• Field of Search: 623/2.11, 623/2.36, 623/2.38, 623/2.39, 606/139, 606/142, 606/151, 606/213, 606/219, 606/228
• 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 2017/0438 slotted, i.e. having a longitudinal slot for enhancing their elasticity
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings

Abstract

Methods for reconfiguring an atrioventricular heart valve may use systems comprising a partial or complete fenestrated annuloplasty ring proportioned to reconfigure a heart valve that has become in some way incompetent, 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. One alternative is to use flexible rings that will bend in the plane of the ring as the heart beats. 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 system for reconfiguring an atrioventricular heart valve, which system comprises

a partial or complete fenestrated annuloplasty ring having a size and shape proportioned to reconfigure a heart valve of a patient that has become in some way incompetent, and a plurality of spaced-apart windows along the length of the ring, and

a plurality of staples having pairs of legs that are each sized to occupy only a minor portion of the area of one window when passed therethrough to be implanted in the heart valve tissue at spaced locations along the length of the ring and thus secure the ring to the heart valve tissue bordering the valve annulus in a manner that permits relative movement between said staples and said ring, whereby a patient'"'"'s heart valve can be reconfigured in a manner that does not deter subtle shifting of the native valve as so to conform the annulus to said ring so the shape of the valve annulus will steadily improve to an optimum configuration where its natural leaflets achieve better coaptation.

2. The system according to claim 1 wherein said staples are made of a shape-memory material and wherein said legs have free ends which change shape to assume a secure angular orientation to the major length thereof following implantation in the tissue of a patient.

3. The system according to claim 1 wherein said staple legs have free ends that form an interlocking orientation following implantation.

4. The system according to claim 1 wherein said annuloplasty fenestrated ring has a plurality of spaced-apart elongated windows which are regularly spaced along the length thereof.

5. The system according to claim 4 wherein the legs of said staples are spaced apart a greater distance than the distance between two adjacent said windows.

6. The system according to claim 1 wherein said ring is planar in shape and made of material that is inextensible but flexible so that said ring will bend in the plane thereof.

7. The system according to claim 6 wherein said ring is formed of wire of circular cross section that is shaped to create a ring including a plurality of loops that provide said windows.

8. The system according to claim 7 wherein said loops are twisted to form closed windows.

9. The system according to claim 7 wherein said wire is bent about a linear core element which adds stability to the ring.

10. The system according to claim 9 wherein said wire is formed to create open loops which are closed by said core element.