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

• US 6,537,198 B1
• Filed: 03/21/2000
• Issued: 03/25/2003
• 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: Vidlund, Robert M., Mortier, Todd J., Schweich, Cyril J. Jr., Paulson, Thomas M., Schroeder, Richard F.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/532,049
• Time in Patent Office: 1,099 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, said elongate member being made of a plurality of filaments in the form of bundles and so that the elongate member has a diameter of approximately 0.030 inches to approximately 0.080 inches;

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

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

wherein the elongate member includes a cable of braided bundles of filaments.

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 each bundle is 180 denier.

4. The apparatus of claim 1, wherein the elongate member is made of approximately 1600 filaments.

5. The apparatus of claim 1, wherein the elongate member has a diameter of approximately 0.55 inches.

6. The apparatus of claim 1, wherein the braided cable has approximately 20 to 50 picks/inch.

7. The apparatus of claim 1, wherein the braided cable has approximately 30 picks/inch.

8. The apparatus of claim 1, wherein the elongate member is a cable of approximately 32 braided bundles of approximately 50 filaments.

9. The apparatus of claim 8, wherein the 32 braided bundles comprise 16 two-ply bundles.

10. The apparatus of claim 1, wherein the filaments are made of ultra high weight polyethylene.

11. The apparatus of claim 1, wherein the elongate member includes a covering over the cable.

12. The apparatus of claim 11, wherein the covering is made of expanded polytetrafluoroethylene.

13. The apparatus of claim 1, wherein the elongate member is made of biostable material.

14. The apparatus of claim 1, wherein the filaments are made of a material chosen from polyesters and liquid crystal polymers.

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

16. The apparatus of claim 1, wherein the second heart-engaging assembly includes a staple configured to secure the second heart-engaging assembly to the elongate member.

17. An apparatus for improving cardiac function, comprising:

an elongate member configured to extend transverse a heart chamber, said elongate member being made of approximately 1600 filaments;

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

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

18. The apparatus of claim 17, wherein the elongate member has a diameter ranging from approximately 0.030 inches to approximately 0.080 inches.

19. The apparatus of claim 17, wherein the elongate member has a diameter of approximately 0.055 inches.

20. The apparatus of claim 17, 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.

21. The apparatus of claim 17, wherein the elongate member includes a cable of braided bundles of the filaments.

22. The apparatus of claim 21, wherein the braided cable has approximately 20 picks/inch to approximately 50 picks/inch.

23. The apparatus of claim 17, wherein the elongate member includes a covering over the cable.

24. The apparatus of claim 23, wherein the covering is made of expanded polytetrafluoroethylene.

25. The apparatus of claim 17, wherein the filaments are made of ultra high molecular weight polyethylene.