CARDIAC HARNESS ASSEMBLY FOR TREATING CONGESTIVE HEART FAILURE AND FOR DEFIBRILLATION AND/OR PACING/SENSING

• US 20090281372A1
• Filed: 05/06/2008
• Published: 11/12/2009
• Est. Priority Date: 05/06/2008
• Status: Abandoned Application

• Current Assignee: Paracor Medical, Inc.
• Original Assignee: Paracor Medical, Inc.
• Inventors: Fishler, Matthew G.
• Application Number:
  US12/115,704
• Publication Number:
  US 20090281372A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: B29C 45/14549 Coating rod-like, wire-like or belt-like articles B29C45/14426 takes precedence
• CPC Class Codes: B29C 45/14778 the article consisting of a material with particular properties, e.g. porous, brittle
• CPC Class Codes: B29K 2083/00 Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29K 2705/00 Use of metals, their alloys or their compounds, for preformed parts, e.g. for inserts

Abstract

A cardiac harness assembly for treating congestive heart failure and for use in defibrillation and/or pacing/sensing is provided. The cardiac harness includes a number of longitudinal ribs spaced apart by connectors, the longitudinal ribs extending from the base to the apex of the heart. The longitudinal ribs have a high degree of longitudinal flexibility so that when the cardiac harness is mounted on the heart, the longitudinal ribs flex along the longitudinal axis of the ribs as the heart expands and contracts circumferentially. The cardiac harness provides a uniform and continuous compressive force on the heart throughout the cardiac cycle.

Claims

1. A cardiac harness, comprising:

a plurality of longitudinal ribs spaced apart and having a base end and an apex end;

a plurality of connectors, the connectors being configured to attach adjacent longitudinal ribs to each other, the connectors extending only between adjacent ribs; and

the longitudinal ribs having a high degree of longitudinal flexibility so that when the cardiac harness is mounted on the heart, the longitudinal ribs flex along a longitudinal axis of the ribs as the heart expands and contracts circumferentially.

2. The cardiac harness of claim 1, wherein the connectors are substantially nondistensible.

3. The cardiac harness of claim 1, wherein the connectors are flexible.

4. The cardiac harness of claim 1, wherein the longitudinal ribs are formed from a superelastic material and the connectors are formed from a polymer material.

5. The cardiac harness of claim 4, wherein the longitudinal ribs are formed from at least one nitinol wire having a diameter in the range of about 0.127 mm to about 0.762 mm (0.005 inch to about 0.030 inch).

6. The cardiac harness of claim 4, wherein the polymer forming the connectors is taken from the group of polymers consisting of silicone rubber, nylons, polyethylene, polypropylene, fluorospolymers and polyurethane.

7. The cardiac harness of claim 1, wherein the connectors can have different sizes and shapes including a bar, a tube, a ring, a sinusoidal segment, a straight segment, an undulating segment, a straight and an undulating segment, a zig zag segment, a bifurcated segment, and a curved segment.

8. The cardiac harness of claim 1, wherein the spacing between adjacent ribs at a base portion of the cardiac harness is greater than the spacing between adjacent ribs at an apex portion of the cardiac harness so that the spacing between the ribs tapers down from the base portion toward the apex portion.

9. The cardiac harness of claim 1, wherein the longitudinal ribs can have different shapes including straight, curved, sinusoidal, and undulating, and different transverse cross-sections including cylindrical, oval, rectangular, square, and I beam.

10. The cardiac harness of claim 9, wherein the cardiac harness has an at-rest configuration and an expanded configuration, the longitudinal ribs being generally undeformed in the at-rest configuration and generally deformed in the expanded configuration.

11. The cardiac harness of claim 1, wherein the cardiac harness has an at-rest configuration and an expanded configuration, the longitudinal ribs being generally undeformed in the at-rest configuration and generally deformed in the expanded configuration.

12. The cardiac harness of claim 1, wherein the longitudinal ribs are coated with dielectric material taken from the group of materials consisting of silicone rubber, polyurethane, parylene, polyester, polyimide, fluoropolymers, and similar materials.

13. A method of treating the heart, comprising:

providing a cardiac harness having a plurality of longitudinal ribs spaced apart and a plurality of connectors attaching adjacent ribs together;

the cardiac harness having an at-rest configuration and a first circumference C₁, and an expanded configuration when mounted on the heart at end diastolic filling, the expanded configuration defining a second circumference C₂;

C₁ being substantially less than C₂; and

the longitudinal ribs elastically deforming with a spring-like force as the cardiac harness expands from the C₁ configuration to the C₂ configuration.

14. The method of claim 13, wherein the cardiac harness applies a compressive force on the heart in the C₂ configuration at end diastolic filling in the range of about 0.5 mm Hg to about 10 mm Hg.

15. The method of claim 13, wherein the longitudinal ribs are formed from a superelastic material and provide a substantially uniform compressive force on the heart throughout the cardiac cycle.

16. The method of claim 13, wherein the connectors have any of lengths L₁, L₂, L₃, up to L_n, and wherein as the cardiac harness expands from the C₁, configuration to the C₂ configuration, the length L₁, L₂, L₃, up to L_n remain substantially the same.

17. A method of mounting a cardiac harness on a heart, comprising:

providing a cardiac harness having a plurality of flexible longitudinal ribs spaced apart and a plurality of connectors attaching adjacent ribs together;

compressing the cardiac harness into a tubular housing;

positioning the tubular housing through a minimally invasive access site in the patient so that the tubular housing is proximate the apex of the heart;

advancing the cardiac harness out of the tubular housing and over the apex of the heart;

further advancing the cardiac harness onto the heart so that the cardiac harness is mounted on the heart and covers a substantial portion of the heart; and

wherein the flexible longitudinal ribs provide column strength to the cardiac harness as the harness is advanced onto the heart.

18. The method of claim 17, wherein the connectors maintain a predetermined spacing between adjacent longitudinal ribs.

19. The method of claim 17, wherein a suction cup assembly associated with the tubular housing is releasably attached to the apex of the heart via a vacuum so that the suction cup assembly can be pulled slightly proximally thereby pulling on the apex and placing the heart in tension and elongating the heart slightly to more easily allow the cardiac harness to advance onto the heart.

20. A method of making a cardiac harness, comprising:

imparting a predetermined at-rest shape to a plurality of superelastic longitudinal ribs;

electropolishing the longitudinal ribs;

cutting the longitudinal ribs to a predetermined length;

position the plurality of longitudinal ribs in an at-rest pattern between two sheets of silicone rubber;

vulcanize the two sheets of silicone rubber together thereby entrapping the ribs;

removing excess silicone rubber so that a plurality of connectors are formed between adjacent longitudinal ribs.

21. The method of claim 20, wherein the ribs have a base end and an apex end, the method further comprising forming an end-cap at the base end and the apex end.

22. The method of claim 20, wherein the cardiac harness is formed into a tapered cylindrical configuration by rolling the silicone rubber sheets into the tapered cylindrical configuration and molding together longitudinal ends of the sheets.

23. A method of making a cardiac harness, comprising

providing a mold for receiving a plurality of longitudinally spaced ribs;

placing the ribs in the mold so that the ribs are spaced apart;

the mold having a plurality of channels between the ribs, the channels at a base end of the mold having a curve with a greater overall path length, and the channels moving toward an apex portion of the mold having a curve with a progressively shorter overall path length; and

injection molding an elastomer into the mold so that the longitudinal ribs are encased in the elastomer and curved connectors are formed in the curved channels thereby connecting adjacent ribs together.

24. The method of claim 23, wherein preformed connectors are attached to the ribs.

25. The method of claim 23, wherein as the cardiac harness is removed from the mold, the curved connectors are straightened so that the longitudinally spaced ribs have a tapered configuration, the ribs being spaced farther apart at a base end and gradually tapering to a narrower spacing between adjacent ribs at an apex end.

26. The method of claim 23, wherein the ribs have any of an undulating configuration, straight configuration, or a combination of undulating and straight configuration, in the mold.

27. The method of claim 23, wherein the connectors are flexible but substantially non-extendable.

28. The method of claim 23, wherein prior to placing the longitudinal ribs in the mold, the longitudinal ribs are jacketed in a dielectric polymer tubing.