Minimally-invasive annuloplasty repair segment delivery template, system and method of use

• US 20030144732A1
• Filed: 01/24/2003
• Published: 07/31/2003
• Est. Priority Date: 10/05/2000
• Status: Active Grant

• Current Assignee: Delos M. Cosgrove, Richard S. Rhee, Stefan Schreck
• Original Assignee: Delos M. Cosgrove, Richard S. Rhee, Stefan Schreck
• Inventors: Schreck, Stefan G., Cosgrove, Delos M., Rhee, Richard S.
• Granted Patent: US 6,962,605 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

An annuloplasty repair segment and template for heart valve annulus repair. The elongate flexible template may form a distal part of a holder that also has a proximal handle. Alternatively, the template may be releasably attached to a mandrel that slides within a delivery sheath, the template being released from the end of the sheath to enable manipulation by a surgeon. A tether connecting the template and mandrel may also be provided. The template may be elastic, temperature responsive, or multiple linked segments. The template may be aligned with the handle and form a two- or three-dimensional curve out of alignment with the handle such that the annuloplasty repair segment attached thereto conforms to the curve. The template may be actively or passively converted between its straight and curved positions. The combined holder and ring is especially suited for minimally-invasive surgeries in which the combination is delivered to an implantation site through a small access incision with or without a cannula, or through a catheter passed though the patient'"'"'s vasculature.

Claims

1. A holder for an annuloplasty repair segment, comprising:

an elongate template adapted to attach to an annuloplasty repair segment and being adapted to pass in a generally linear shape through a tube, the template being convertible from the generally linear shape to a curved shape.

2. The holder of claim 1, wherein the template is flexible.

3. The holder of claim 2, wherein the template is biased toward the curved shape.

4. The holder of claim 1, wherein the curved shape is three-dimensional.

5. The holder of claim 1, further including a deflection mechanism for converting the template between the linear shape and the curved shape.

6. The holder of claim 1, wherein the template is capable of a temperature-induced shape change between the linear shape and the curved shape.

7. The holder of claim 1, wherein the template includes a plurality of hinged sections.

8. The holder of claim 7, further including a deflection mechanism for converting the template between the linear shape and the curved shape.

9. The holder of claim 1, wherein the template is flexible but unbiased from the linear shape, the holder further including a biasing member adapted to insert within the template so as to bias the template toward the curved shape.

10. The holder of claim 1, further including a handle attached to the template for passing the template through the tube and for manipulating the template to position the annuloplasty repair segment into proximity with a valve annulus.

11. The holder of claim 1, further including an anchor mandrel to which the template is releasably attached, and a tether connecting the template and anchor mandrel when released.

12. The holder of claim 1, further including suture location markers on the template to facilitate suture alignment with anatomical landmarks.

13. A combination annuloplasty repair segment and holder, comprising:

a holder including a template having a generally linear shape in at least one position, the template being adapted to undergo a shape change along its length; and

an annuloplasty repair segment attached to the template and configured to assume the changed shape of the template.

14. The combination of claim 13, wherein the template is flexible and the shape change occurs from bending of the template.

15. The combination of claim 13, wherein the template is biased toward the changed shape.

16. The combination of claim 13, wherein the changed shape is a curve.

17. The combination of claim 13, wherein the curve is three-dimensional.

18. The combination of claim 13, further including a deflection mechanism for converting the template between the linear shape and the changed shape.

19. The combination of claim 13, wherein the template includes a plurality of hinged sections.

20. The combination of claim 19, further including a deflection mechanism for converting the template between the linear shape and the curved shape.

21. The combination of claim 13, wherein the template is capable of a temperature-induced shape change between the linear shape and the changed shape.

22. The combination of claim 13, wherein the template is flexible but unbiased from the linear shape, the holder further including a biasing member adapted to insert within the template so as to bias the template toward the curved shape.

23. The combination of claim 13, further including a handle attached to the template for manipulating the template to position the annuloplasty repair segment into proximity with a valve annulus.

24. The combination of claim 13, further including an anchor mandrel to which the template is releasably attached, and a tether connecting the template and anchor mandrel when released.

25. The combination of claim 13, further including suture location markers on the template to facilitate suture alignment with anatomical landmarks.

26. An annuloplasty repair segment delivery system, comprising:

a delivery sheath;

an anchor mandrel slidably disposed within the sheath near a distal end thereof and restrained from exiting the sheath; and

an elongate template adapted to attach to a flexible annuloplasty repair segment and being releasably attached to the anchor mandrel, the template being convertible from a generally linear shape within the sheath to a curved shape when ejected from the end of the sheath.

27. The system of claim 26, further including a tether connecting the template and anchor mandrel when released.

28. The system of claim 26, wherein the template is biased toward the changed shape.

29. The system of claim 26, wherein the changed shape is a curve.

30. The system of claim 29, wherein the curve is three-dimensional.

31. The system of claim 26, wherein the template includes a handle portion and a forming portion, the forming portion being biased into a curved shape and being attached to the flexible annuloplasty repair segment so that the segment also assumes the curved shape.

32. The system of claim 31, wherein the forming portion inserts within the segment.

33. A method of implanting an annuloplasty repair segment in a heart valve annulus, comprising:

providing a holder having a flexible template adapted to attach to an annuloplasty repair segment, the template being convertible from a generally linear shape to a curved shape;

attaching an annuloplasty repair segment to the flexible template;

delivering the repair segment attached to the template to a heart valve annulus;

causing the template and repair segment to simultaneously undergo a shape change; and

attaching the annuloplasty repair segment to the annulus.

34. The method of claim 33, wherein the step of delivering includes delivering the annuloplasty repair segment attached to the template through a minimally-invasive tube.

35. The method of claim 34, wherein the minimally-invasive tube is first inserted through an access incision in the chest wall into proximity with the annulus.

36. The method of claim 34, wherein the minimally-invasive tube is first inserted through an access incision in the peripheral vasculature and passed through the vascular system into proximity with the annulus.

37. The method of claim 34, further including releasing the template from the tube after delivering the template through the tube.

38. The method of claim 37, wherein the holder includes an anchor mandrel slidable within the tube but constrained from exiting the tube, and the elongate template is releasably attached to the anchor mandrel.

39. The method of claim 38, further including a tether connecting the template and anchor mandrel when released.