Methods and systems for cardiac remodeling via resynchronization

• US 7,877,142 B2
• Filed: 07/03/2007
• Issued: 01/25/2011
• Est. Priority Date: 07/05/2006
• Status: Expired due to Fees

• Current Assignee: MiCardia Corporation
• Original Assignee: MiCardia Corporation
• Inventors: Moaddeb, Shahram, Shaoulian, Emanuel, Shaolian, Samuel M.
• Primary Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US11/773,311
• Publication Number:
  US 20080051840A1
• Time in Patent Office: 1,302 Days
• Field of Search: None
• US Class Current: 607/9
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Systems, methods and devices are provided for improving the hemodynamic efficiency of a patient'"'"'s heart by implanting one or more reinforcement elements on or with the heart and providing electrical stimulation to the heart. The reinforcement elements may include magnetic and/or shape memory material and are configured to reshape the heart so as to boost the heart'"'"'s mechanical energy during a response to the electrical stimulation. In some embodiments, at least one reinforcement element includes an electrode configured to sense electrocardiogram signals within the heart. An electrical stimulation device such as an implantable or external pacemaker/defibrillator may be configured to control delivery of electrical pulses to the heart based on the sensed electrocardiogram signals. In addition, or in other embodiments, at least one reinforcement element includes an electrode configured to deliver the electrical pulses to the heart.

Claims

1. A method for improving the hemodynamic efficiency of a heart, the method comprising:

implanting at least one reinforcement element within a wall of the heart; and

electrically stimulating the heart;

wherein the at least one reinforcement element is configured to increase the heart'"'"'s mechanical energy during a response to the electrical stimulation.

2. The method of claim 1, further comprising:

detecting electrocardiogram signals through the at least one reinforcement element implanted within the wall of the heart; and

based on the detected electrocardiogram signals, controlling delivery of an electrical impulse configured to provide the electrical stimulation.

3. The method of claim 1, further comprising delivering an electrical impulse through the at least one reinforcement element implanted within the wall of the heart, the electrical impulse configured to provide the electrical stimulation to the heart.

4. The method of claim 3, further comprising selectively delivering the electrical impulse based on a detected signal related to the mechanical motion of the heart.

5. The method of claim 1, further comprising, after implantation, delivering sufficient activation energy to the at least one reinforcement element to change a configuration of the at least one reinforcement element, wherein the activation energy is selected from the group comprising thermal energy, a magnetic energy, acoustic energy, and electromagnetic energy.

6. The method of claim 1, further comprising implanting the at least one reinforcement element through at least one of a percutaneous approach within the heart, an epicardial approach from outside of the heart, and an open lumen catheter with an extendible and retractable hollow needle.

7. A system for improving the hemodynamic efficiency of a heart, the system comprising:

an electrical stimulation device configured to deliver an electrical impulse to the heart;

at least one reinforcement element implantable at least partially within a tissue area of the heart, the at least one reinforcement element configured to increase the heart'"'"'s mechanical energy during a response to the electrical impulse; and

a lead electrically coupled to the electrical stimulation device, the lead comprising;

a first electrode configured to deliver the electrical impulse to a tissue area of the heart; and

a second electrode configured to deliver activation enerqy to the at least one reinforcement element,

wherein the first electrode is located in a tip of the lead and the second electrode is located within a recess of the first electrode such that both the first and second electrode contact the tissue area of the heart in close proximity to the at least one reinforcement element.

8. The system of claim 7, wherein the at least one reinforcement element is configured to attach to a surface of the heart.

9. The system of claim 7, wherein the electrical stimulation device is selected from the group comprising a pacemaker and a defibrillator.

10. The system of claim 7, wherein the at least one reinforcement element comprises a shape memory material, the shape memory material being transitionable between an original shape and at least one memory shape, wherein the original shape is configured for at least partial implantation within the tissue area of the heart, and wherein the at least one memory shape is configured to apply force to the tissue area of the heart in order to reshape the tissue area of the heart after receiving sufficient activation energy.

11. The system of claim 10, wherein the electrical stimulation device is configured to deliver the activation energy to the at least one reinforcement element, the activation energy selected from the group comprising thermal energy, magnetic fields, acoustic energy, and electromagnetic energy.

12. The system of claim 10, wherein the shape memory material comprises a shape memory polymer.

13. The system of claim 10, wherein the shape memory material comprises a shape memory metal or metal alloy.

14. The system of claim 13, wherein the shape memory metal or metal alloy is configured to exhibit a paramagnetic or ferromagnetic transition.

15. The system of claim 7, further comprising:

diagnostic circuitry configured to analyze depolarizations within the heart; and

an electrode electrically connected to the diagnostic circuitry, the electrode configured to sense the depolarizations within the heart,

wherein the electrical simulation device is configured to stimulate the heart based on the sensed depolarizations.

16. The system of claim 15, wherein the diagnostic circuitry is configured to coordinate at least one of an output signal magnitude and a rate of change of magnitude with heart contraction and ejection fraction values.

17. The system of claim 7, wherein the lead further comprises a screw-in tip to secure the lead to the tissue area of the heart.

18. The system of claim 7, wherein the at least one reinforcement element comprises at least one magnetic element.

19. The system of claim 18, wherein the at least one magnetic element comprises a magnetic core comprising at least one of Neudynium Iron Boron, Samarium Cobalt, and Aluminum Nickel Cobalt.

20. A system comprising:

means for electrically stimulating a patient'"'"'s heart; and

means for reshaping the heart to increase the heart'"'"'s mechanical energy during a response to the electrical stimulation, the means for reshaping the heart configured to be implanted within a wall of the heart.

21. The system of claim 20, wherein the means for reshaping the heart is configured to sense depolarizations within the patient'"'"'s heart, and wherein the means for electrically stimulating the heart provides an electrical impulse based on the sensed depolarizations.

22. The system of claim 20, wherein the means for reshaping the heart is configured to deliver an electrical impulse provided by the means for electrically stimulating the patient'"'"'s heart.