Splint assembly for improving cardiac function in hearts, and method for implanting the splint assembly

• US 7,044,905 B2
• Filed: 10/24/2002
• Issued: 05/16/2006
• Est. Priority Date: 03/21/2000
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Paulson, Thomas, Schroeder, Richard, Mortier, Todd, Kusz, David, Vidlund, Robert, Schweich, Cyril Jr., LaPlante, Jeffrey
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US10/278,847
• Publication Number:
  US 20030050529A1
• Time in Patent Office: 1,300 Days
• Field of Search: 600 16- 18, 600/37, 601/11, 623/3, 623/3.1, 623/904, 623/910, 128/898, 128/899
• US Class Current: 600/16
• 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 17/0401 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 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

A splint assembly for placement transverse a heart chamber to reduce the heart chamber radius and improve cardiac function has a tension member formed of a braided cable with a covering. A fixed anchor assembly is attached to one end of the tension member and a leader for penetrating a heart wall and guiding the tension member through the heart is attached to the other end. An adjustable anchor assembly can be secured onto the tension member opposite to the side on which the fixed pad assembly is attached. The adjustable anchor assembly can be positioned along the tension member so as to adjust the length of the tension member extending between the fixed and adjustable anchor assemblies. The pad assemblies engage with the outside of the heart wall to hold the tension member in place transverse the heart chamber. A probe and marker delivery device is used to identify locations on the heart wall to place the splint assembly such that it will not interfere with internal heart structures. The device delivers a marker to these locations on the heart wall for both visual and tactile identification during implantation of the splint assembly in the heart.

Claims

1. An apparatus for improving cardiac function, comprising:

an elongate member configured to extend transverse a heart chamber;

a first heart-engaging assembly attached to the elongate member and configured to engage a first exterior location of a heart wall;

a second heart-engaging assembly configured to be secured onto the elongate member and to engage a second exterior location of the heart wall; and

a fixation member configured to penetrate the elongate member to thereby hold at least one of the first heart-engaging assembly and the second heart-engaging assembly in a fixed position along the elongate member.

2. The apparatus of claim 1, wherein the second heart-engaging assembly is configured to be slidably positioned along the elongate member prior to securement to the elongate member such that a length of the elongate member between the first and second heart-engaging assemblies can be adjusted during placement of the elongate member transverse the heart chamber.

3. The apparatus of claim 1, wherein the first heart-engaging assembly is fixedly attached to the elongate member.

4. The apparatus of claim 1, wherein surfaces of the first and second heart-engaging assemblies engaging the heart wall have substantially convex configurations relative to the heart wall.

5. The apparatus of claim 1, wherein the elongate member extends through apertures defined by each of the first and second heart-engaging assemblies.

6. The apparatus of claim 1, wherein each of the first and second heart-engaging assemblies has a substantially disk-like shape.

7. The apparatus of claim 6, wherein each of the first and second heart-engaging assemblies has a diameter of approximately 1.9 cm.

8. The apparatus of claim 1, wherein each of the first and second heart-engaging assemblies is made of a rigid thermoplastic material.

9. The apparatus of claim 1, wherein each of the first and second heart-engaging assemblies includes a covering made of a material facilitating tissue ingrowth.

10. The apparatus of claim 1, wherein the first heart-engaging assembly includes the fixation member and the fixation member is configured to engage the elongate member to attach the elongate member to the first heart-engaging assembly.

11. The apparatus of claim 10, wherein the elongate member and the fixation member extend substantially perpendicular to each other.

12. The apparatus of claim 11, wherein the elongate member folds within a portion of the first heart-engaging assembly such that the fixation member engages the elongate member in two locations.

13. The apparatus of claim 12, wherein the first heart-engaging assembly includes a channel for receiving the fixation member.

14. The apparatus of claim 10, wherein the fixation member includes a sharpened pin.

15. The apparatus of claim 10, wherein two fixation members extend substantially parallel to each other and perpendicular to the elongate member to attach the first heart-engaging assembly to the elongate member.

16. The apparatus of claim 1, wherein the second heart-engaging assembly is configured to be selectively secured along a length of the elongate member.

17. The apparatus of claim 1, wherein the second heart-engaging assembly includes the fixation member to secure the second heart-engaging assembly to the elongate member.

18. The apparatus of claim 17, wherein the fixation member is actuatable.

19. The apparatus of claim 18, wherein prior to actuation of the fixation member, the second heart-engaging assembly is movable relative to a length of the elongate member.

20. The apparatus of claim 18, wherein the second heart-engaging assembly includes a channel along which the actuatable fixation member advances to penetrate the elongate member.

21. The apparatus of claim 18, wherein the second heart engaging assembly is configured to engage with an actuator to actuate the fixation member.

22. The apparatus of claim 17, wherein the fixation member includes a staple.

23. The apparatus of claim 18, wherein the second heart-engaging assembly includes a safety mechanism to prevent the actuatable fixation member from advancing prior to actuation and from disengaging from the elongate member after penetration thereof.

24. The apparatus of claim 1, wherein the fixation member includes a first fixation member and a second fixation member, the first fixation member configured to penetrate the elongate member and hold the first heart-engaging assembly in a fixed position along a length of the elongate member, and the second fixation member configured to penetrate the elongate member and hold the second heart-engaging assembly in a fixed position along the length of the elongate member.

25. The apparatus of claim 24, wherein the second fixation member is actuatable to selectively secure the second heart-engaging assembly along the length of the elongate member during placement of the elongate member transverse the heart chamber.