Sensor-equipped and algorithm controlled direct mechanical ventricular assist device

• US 20060142634A1
• Filed: 02/23/2006
• Published: 06/29/2006
• Est. Priority Date: 06/26/2003
• Status: Abandoned Application

• Current Assignee: Myocardiocare, Inc.
• Original Assignee: Advanced Resuscitation LLC
• Inventors: MacDonald, Stuart G., Anstadt, Mark P., Helfer, Jeffrey L., Anstadt, George W., Anstadt, George L.
• Application Number:
  US11/359,542
• Publication Number:
  US 20060142634A1
• Time in Patent Office: Days
• US Class Current: 600/16
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/202 partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 60/191 mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: A61M 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/523 using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

An apparatus for assisting the function of a heart disposed within a body. The apparatus can apply a compressive force and an expansive force to a portion of the outer wall of the heart. The apparatus can comprise a cup-shaped shell having an exterior wall, an interior wall, an apex, and an upper edge; a liner having an outer surface and an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell, thereby forming a cavity between the outer surface thereof and the interior wall of the shell; and a drive fluid within the cavity. The drive fluid can apply a force on a portion of the outer wall of the heart.

Claims

1. An apparatus for assisting the function of a heart disposed within a body, the apparatus comprising:

a cup-shaped shell including an interior wall and an exterior wall;

a liner including an outer surface, portions of the outer surface joined to portions of the interior wall of the cup-shaped shell such that a cavity is formed between the outer surface and the interior wall; and

a seal including a base, a tapered midsection and a tip, the tip adapted to be deployed contiguously with the heart.

2. The apparatus of claim 1, wherein the liner and the seal are unitary.

3. The apparatus of claim 2, wherein the liner and the seal are formed by a molding process.

4. The apparatus of claim 2, wherein the liner and the seal are of heat cured liquid silicone rubber.

5. The apparatus of claim 1, wherein the seal further comprises a ring disposed proximate to the tip, and a mating groove formed in the exterior wall of the shell proximate to the seal.

6. The apparatus of claim 5, further comprising:

a cavity disposed within the tapered midsection of the seal; and

a lumen connected to the cavity disposed within the tapered midsection and to a fluid source.

7. The apparatus of claim 1, wherein the seal is biocompatible.

8. The apparatus of claim 1, wherein the seal is biodegradable.

9. The apparatus of claim 1, wherein the seal is detachable from the upper edge of the cup-shaped shell.

10. The apparatus of claim 1, wherein the seal comprises a first therapeutic agent.

11. The apparatus of claim 10, wherein the first therapeutic agent is diffused throughout the seal.

12. The apparatus of claim 10, wherein the first therapeutic agent comprises a coating on the outer surface of the seal.

13. The apparatus of claim 10, wherein a cavity is disposed within the seal, and the first therapeutic agent is disposed within the cavity disposed within the seal.

14. The apparatus of claim 10, wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.

15. The apparatus of claim 10, wherein the seal further comprises a second therapeutic agent.

16. The apparatus of claim 1, wherein the seal has a textured outer surface.

17. The apparatus of claim 1, wherein the liner is an elastic liner.

18. The apparatus of claim 17, wherein the elastic liner is of silicone polymer.

19. The apparatus of claim 1, wherein the liner is detachable from the interior wall of the cup-shaped shell.

20. The apparatus of claim 1, wherein the liner comprises a first therapeutic agent.

21. The apparatus of claim 20, wherein the first therapeutic agent is diffused throughout the liner.

22. The apparatus of claim 20, wherein the first therapeutic agent comprises a coating on an inner surface of the liner.

23. The apparatus of claim 20, wherein the liner comprises a first membrane and a second membrane, and the first therapeutic agent is disposed between the first and second membranes.

24. The apparatus of claim 20, wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.

25. The apparatus of in claim 20, wherein the liner further comprises a second therapeutic agent.

26. The apparatus of claim 1, wherein the liner has a textured inner surface.

27. The apparatus of claim 1, wherein the liner comprises:

a first membrane including an outer surface, an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell; and

a second membrane including an outer surface and an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell;

wherein the inner surface of the first membrane is contiguous with the outer surface of the second membrane.

28. The apparatus of claim 1, wherein the liner is a rolling diaphragm liner.

29. An apparatus for assisting the function of a heart disposed within a body, the apparatus comprising:

a cup-shaped shell including an interior wall, an exterior wall and an upper edge;

a liner including an outer surface, portions of the outer surface joined to the interior wall such that a cavity is defined between the outer surface and the interior wall; and

a seal joined to the upper edge, the seal unitary with the liner.

30. The apparatus of claim 29, wherein the seal further comprises a base joined to the upper edge of the cup-shaped shell, a tapered midsection, and a tip, the tip adapted to be deployed contiguously against the heart.

31. The apparatus of claim 29, wherein the liner and the seal are formed by a molding process.

32. The apparatus of claim 30, wherein the liner and the seal are of heat cured liquid silicone rubber.

33. The apparatus of claim 30, wherein the seal further comprises a ring disposed proximate to the tip and a mating groove formed in the exterior wall of the shell proximate to the seal.

34. The apparatus of claim 30, further comprising a cavity disposed within the tapered midsection of the seal and a lumen connected to the cavity and to a fluid source.

35. The apparatus of claim 29, wherein the seal is biocompatible.

36. The apparatus of claim 29, wherein the seal is biodegradable.

37. The apparatus of claim 29, wherein the seal is detachable from the upper edge of the cup-shaped shell.

38. The apparatus of claim 29, wherein the seal comprises a first therapeutic agent.

39. The apparatus of claim 38, wherein the first therapeutic agent is diffused throughout the seal.

40. The apparatus of claim 38, wherein the first therapeutic agent comprises a coating on the outer surface of the seal.

41. The apparatus of claim 38, wherein a cavity is disposed within the seal, and the first therapeutic agent is disposed within the cavity disposed within the seal.

42. The apparatus of claim 38, wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.

43. The apparatus of claim 38, wherein the seal further comprises a second therapeutic agent.

44. The apparatus of claim 29, wherein the seal has a textured outer surface.

45. The apparatus of claim 29, wherein the liner is an elastic liner.

46. The apparatus of claim 45, wherein the elastic liner is of silicone polymer.

47. The apparatus of claim 29, wherein the liner is detachable from the interior wall of the cup-shaped shell.

48. The apparatus of claim 29, wherein the liner comprises a first therapeutic agent.

49. The apparatus of claim 48, wherein the first therapeutic agent is diffused throughout the liner.

50. The apparatus of claim 48, wherein the first therapeutic agent comprises a coating on an inner surface of the liner.

51. The apparatus of claim 48, wherein the liner comprises a first membrane and a second membrane, and the first therapeutic agent is disposed between the first and the second membranes.

52. The apparatus of claim 48, wherein the first therapeutic agent is selected from the group consisting of anti-inflammatory agents, gene therapy agents, gene transfer agents, stem cells, chemo-attractants, cell regeneration agents, ventricular remodeling agents, anti-infection agents, tumor suppressants, tissue and/or cell engineering agents, imaging contrast agents, tissue staining agents, nutrients, and mixtures thereof.

53. The apparatus of claim 48, wherein the liner further comprises a second therapeutic agent.

54. The apparatus of claim 29, wherein the liner has a textured inner surface.

55. The apparatus of claim 29, wherein the liner comprises:

a first membrane including an outer surface, an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell; and

a second membrane including an outer surface, an inner surface, an upper edge joined to the interior wall of the cup-shaped shell, and a lower edge joined to the interior wall of the cup-shaped shell;

wherein the inner surface of the first membrane is contiguous with the outer surface of the second membrane.

56. The apparatus of claim 29, wherein the liner is a rolling diaphragm liner.