Cardiac disease treatment and device

• US 6,730,016 B1
• Filed: 06/12/2000
• Issued: 05/04/2004
• Est. Priority Date: 06/12/2000
• Status: Expired due to Term

• Current Assignee: Acorn Cardiovascular, Inc.
• Original Assignee: Acorn Cardiovascular, Inc.
• Inventors: Sabbah, Hani N., Walsh, Robert G., Cox, James, Shapland, J. Edward II, Girard, Michael J., Rohrbaugh, Donald G., Palme, Donald F. II
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/591,875
• Time in Patent Office: 1,422 Days
• Field of Search: 600/37, 600/18, 600/17, 600/16, 424/422, 424/423, 424/424, 424/426, 424/427, 424/430, 424/434, 424/437, 424/489, 424/490, 514/814, 514/866, 514/822, 523/112, 523/113, 427/2.24, 427/2.25, 128/897, 606/151, 606/154, 607/129
• 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: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: D04B 21/12 characterised by thread material
• CPC Class Codes: D10B 2509/08 Hernia repair mesh
• CPC Class Codes: Y10S 977/907 Liposome

Abstract

A device for treating cardiac disease of a heart having an upper portion and a lower portion divided by an A-V groove, the device including a jacket adapted to be secured to the heart, and a non-adherent material in association with the jacket. The jacket is fabricated from a flexible material defining a volume between an upper and a lower end, the jacket being adapted to be adjusted on the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume for the jacket to constrain expansion of the heart beyond the maximum adjusted volume during diastole and permit substantially unimpeded contraction of the heart during systole. As a result of the flexible material, the jacket allows unimpeded diastolic filling of the heart. Also described is a method for treating cardiac disease including surgically accessing the heart, applying the treatment device of the invention, securing the treatment device to the heart, and surgically closing access to the heart while leaving the treatment device on the heart.

Claims

1. A device for treating cardiac disease of a heart having an upper portion and a lower portion divided by an A-V groove, the device comprising:

a. a jacket of flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole; and

b. a non-adherent lining in association with the jacket wherein the non-adherent lining is provided in the form of one or more ribs extending from a base to an apex of the heart.

2. A device for treating cardiac disease of a heart having an upper portion and a lower portion divided by an A-V groove, the device comprising:

a. a jacket of flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole;

b. a non-adherent lining in association with the jacket; and

c. a delivery source for the delivery of one or more therapeutic agents to the surface of the heart.

3. The device according to claim 2 wherein the device provides localized delivery of the one or more therapeutic agents to a target area on the surface of the heart.

4. The device according to claim 2 wherein the therapeutic agent comprises a pharmacological agent.

5. The device according to claim 2 wherein the therapeutic agent comprises cellular material.

6. The device according to claim 2 wherein the delivery source comprises a coating on the jacket.

7. The device according to claim 2 wherein the delivery source comprises a separable element from the jacket.

8. The device according to claim 2 wherein the delivery source for the delivery of one or more therapeutic agents is provided at an area of the jacket that overlaps an area of the non-adherent material.

9. The device according to claim 8 wherein the non-adherent material is permeable to the therapeutic agent(s).

10. The device according to claim 2 wherein the delivery source for the delivery of one or more therapeutic agents is provided at an area of the jacket that is separate from an area of the non-adherent material.

11. A method for treating cardiac disease, the method comprising:

a. surgically accessing the heart;

b. applying a treatment device on the heart, the device comprising;

1) a jacket of flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain circumferential expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole; and

2) a non-adherent lining in association with the jacket, wherein the non-adherent lining is provided in the form of one or more ribs extending from a base to an apex of the heart;

c. securing the treatment device to the heart; and

d. surgically closing access to the heart while leaving the treatment device on the heart.

12. A method for treating cardiac disease, the method comprising:

a. surgically accessing the heart;

b. applying a treatment device on the heart, the device comprising;

1) a jacket of flexible material defining a volume between at upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain circumferential expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole;

2) a non-adherent lining; and

3) a delivery source for delivery of one or more therapeutic agents to the surface of the heart;

c. securing the treatment device to the heart; and

d. surgically closing access to the heart while leaving the treatment device on the heart.

13. The method according to claim 12, wherein the one or more therapeutic agents comprise one or more pharmacological agents.

14. The method according to claim 12 wherein the one or more therapeutic agents comprise cellular material.

15. A device for treating cardiac disease of a heart having an upper portion and a lower portion divided by an A-V groove, the device comprising:

a. a jacket of flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole; and

b. a non-adherent coating in association with the jacket, wherein the non-adherent coating is configured to cover only selected areas of the heart.

16. The device according to claim 15 wherein the jacket comprises an elastic material.

17. The device according to claim 15, wherein the jacket comprises an open cell material.

18. A device for treating cardiac disease of a heart having an upper portion and a lower portion divided by an A-V groove, the device comprising:

a. a jacket comprised of an open cell flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole; and

b. a non-adherent coating in association with the jacket wherein the open cell material defines interstitial spaces and the non-adherent coating fills the interstitial spaces defined by the open cell material.

19. A device for treating cardiac disease of a heart having an upper portion and a lower portion divided by an A-V groove, the device comprising:

a. a jacket of flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole, the jacket comprising a biodegradable material; and

b. a non-adherent coating in association with the jacket.

20. A device for treating cardiac disease of a heart having an upper portion and a lower portion divided by an A-V groove, the device comprising:

a. a jacket of flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole; and

b. a non-adherent coating in association with the jacket, wherein the non-adherent material provided in the form of one or more ribs extending from a base to an apex of the heart.

21. A device for treating cardiac disease of a heart having an upper portion and a lower portion divided by an A-V groove, the device comprising:

a. a jacket of flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole;

b. a non-adherent coating in association with the jacket; and

c. a delivery source for the delivery of one or more therapeutic agents to the surface of the heart.

22. The device according to claim 21 wherein the device provides localized delivery of the one or more therapeutic agents to a target area on the surface of the heart.

23. The device according to claim 21 wherein the therapeutic agent comprises a pharmacological agent.

24. The device according to claim 21 wherein the therapeutic agent comprises cellular material.

25. The device according to claim 21 the delivery source comprises a coating on the jacket.

26. The device according to claim 21 wherein the delivery source comprises a separable element from the jacket.

27. The device according to claim 21 wherein the delivery source for the delivery of one or more therapeutic agents is provided at an area of the jacket that overlaps an area of the non-adherent material.

28. The device according to claim 21 wherein the non-adherent material is permeable to the therapeutic agent(s).

29. The device according to claim 21 wherein the delivery source for the delivery of one or more therapeutic agents is provided at an area of the jacket that is separate from an area of the non-adherent material.

30. A method for treating cardiac disease, the method comprising:

a. surgically accessing the heart;

b. applying a treatment device on the heart, the device comprising;

1) a jacket of flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain circumferential expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole; and

2) a non-adherent coating in association with the jacket, wherein the non-adherent coating is configured to contact only selected areas of the heart;

c. securing the treatment device to the heart; and

d. surgically closing access to the heart while leaving the treatment device on the heart.

31. A method for treating cardiac disease, the method comprising:

a surgically accessing the heart;

b. applying a treatment device oil the heart, the device comprising;

1) a jacket of flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain circumferential expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole; and

2), a non-adherent coating in association with the jacket, wherein the non-adherent material is provided in the form of one or more ribs extending from a base to an apex of the heart;

c. securing the treatment device to the heart; and

d. surgically closing access to the heart while leaving the treatment device on the heart.

33. The method according to claim 31, wherein the one or more therapeutic agents comprise one or more pharmacological agents.

34. The method according to claim 31 wherein the one or more therapeutic agents comprise cellular material.

35. The device according to claim 31, wherein the jacket comprises an open cell material.

36. The device according to claim 35, wherein the open cell material defines interstitial spaces and the non-adherent coating fills the interstitial spaces defined by the open cell material.

32. A method for treating cardiac disease, the method comprising:

a. surgically accessing the heart;

b. applying a treatment device on the heart, the device comprising;

1) a jacket of flexible material defining a volume between an upper end and a lower end, the jacket adapted to be secured to the heart and adapted to be adjusted on the heart to snugly conform to an external geometry of the heart to constrain circumferential expansion of the heart during diastole and permit substantially unimpeded contraction of the heart during systole;

2) a non-adherent coating in association with the jacket; and

3) a delivery source for delivery of one or more therapeutic agents to the surface of the heart;

c. securing the treatment device to the heart; and

d. surgically closing access to the heart while leaving the treatment device on the heart.