Device for proactive modulation of cardiac strain patterns

• US 8,187,160 B2
• Filed: 09/30/2008
• Issued: 05/29/2012
• Est. Priority Date: 06/18/2003
• Status: Active Grant

• Current Assignee: Texas A&M University System
• Original Assignee: Texas A&M University System
• Inventors: Criscione, John C., Biswas, Saurabh
• Primary Examiner(s): Lacyk, John
• Application Number:
  US12/242,197
• Publication Number:
  US 20090036730A1
• Time in Patent Office: 1,337 Days
• Field of Search: 600 16- 18, 600/37
• 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 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 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

Abstract

A direct cardiac assist device which may aid in ventricular recovery. The device proactively modulates cardiac strain pattern to produce a contraction strain pattern that induces beneficial growth and remodeling of the myocardium or prevents or reduces apoptosis of the myocytes. The device may include an outer shell. membrane, or mesh and an inner membrane. The space between the outer member and the membrane may be filled with fluid that is pressurized during contraction. The device prescribes a beneficial strain pattern during heart contraction. This strain pattern does not invert the curvatures or grossly alter the curvatures of the heart and may assist in myocyte regrowth and healing of the failing heart.

Claims

1. A direct cardiac compression device adapted to surround the heart comprising:

an outer shell comprising a basal annulus opposite an apical annulus and a series of rods that span between the basal annulus and the apical annulus to form a vase-shaped outer shell;

an inner membrane in contact with the outer shell having a contour profile from a basal end to an apical end to surround the heart; and

one or more contoured chambers formed between the outer shell and the inner membrane to selectively compress the heart to actively promote a contraction strain pattern characterized by non-inversion or lack of gross perturbation of the curvature on a diseased or damaged myocardium that promotes beneficial growth and remodeling of the myocardium.

2. The device of claim 1, wherein the outer shell, the inner membrane, or both are made of or more membranes.

3. The device of claim 1, wherein the series of rods comprises a series of adjustable rods to form an adjustable shell around the heart.

4. The device of claim 1, wherein the inner membrane comprises one or more metal stents.

5. The device of claim 1, wherein the outer shell comprises a rigid outer shell structure.

6. The device of claim 1, wherein the outer shell comprises an outer shell membrane, or mesh.

7. The device of claim 1, wherein the contour profile has a larger basal end contoured to a smaller apical end to surround the heart.

8. The device of claim 1, further comprising a connector adapted to secure the ventricular portion of the heart.

9. The device of claim 1, further comprising a device anchor adapted to secure the device about the valve plane of the heart.

10. The device of claim 1, further comprising a pneumatic drive operable to pressurize the inner membrane.

11. The device of claim 1, wherein the inner membrane comprises an elastomeric biocompatible material.

12. A method of assisting a diseased or damaged heart comprising the steps of:

positioning a direct cardiac compression device around the heart, wherein the direct cardiac compression device comprises;

an outer shell in contact with an inner membrane, wherein the outer shell comprises a basal annulus opposite an apical annulus and a series of rods that span between the basal annulus and the apical annulus to form a vase-shaped outer shell, and

one or more contoured chambers formed between the outer shell and the inner membrane having a contour profile from a basal end to a apical end to surround the heart to selectively compress the heart to actively promote a contraction strain pattern characterized by non-inversion or lack of gross perturbation of the curvature on a diseased or damaged myocardium that promotes beneficial growth and remodeling of the myocardium;

pressurizing selectively the direct cardiac compression device to compress the heart 1 during contraction without inverting or significantly perturbing the curvatures of the heart; and

depressurizing selectively the direct cardiac compression device.

13. The method of claim 12, further comprising opening the chest cavity of a patient to provide access to the heart;

and attaching the device of to the valve plane of the heart.

14. The method of claim 12, further comprising the step of further pressurizing selectively and depressurizing selectively the direct cardiac compression device to induce ventricular recovery in the heart.

15. The method of claim 12, further comprising the step of further pressurizing selectively and depressurizing selectively the direct cardiac compression device to prevent apoptosis of myocytes in the myocardium.

16. The method of claim 12, further comprising the step of further pressurizing selectively and depressurizing selectively the direct cardiac compression device to preserve the myocardium in a borderzone of a myocardial infarct.

17. A method of promoting growth and remodeling of the myocardium comprising the steps of:

positioning a direct cardiac compression device around the heart, wherein the direct cardiac compression device comprises;

an outer shell comprising a basal annulus opposite an apical annulus and a series of rods that span between the basal annulus and the apical annulus to form a vase-shaped outer shell, and

an inner membrane in contact with the outer shell having a basal end contoured to a apical end to surround the heart, one or more contoured chambers formed between the outer shell and the inner membrane to selectively compress the heart to actively promote a contraction strain pattern characterized by non-inversion or lack of gross perturbation of the curvature on a diseased or damaged myocardium that promotes beneficial growth and remodeling of the myocardium;

pressurizing selectively the direct cardiac compression device to compress the heart 1 during contraction without inverting or significantly perturbing the curvatures of the heart; and

depressurizing selectively the direct cardiac compression device.