Intramyocardial patterning for global cardiac resizing and reshaping

Patent metadata

Field	Value
Publication number	US-9782258-B2
Application number	US-90000507-A
Country	US
Kind code	B2
Filing date	Sep 7, 2007
Priority date	Sep 8, 2006
Publication date	Oct 10, 2017
Grant date	Oct 10, 2017

Abstract

Cardiomyopathy may be treated by distributing space-occupying agent within the myocardium in a pattern about one or more chambers of the heart, such that the space-modifying agent integrates into and thickens at least part of the cardiac wall about the chamber so as globally to reduce wall stress and stabilize or even reduce chamber size. Some patterns also cause a beneficial global reshaping of the chamber. These changes occur quickly and are sustainable, and have a rapid and sustainable therapeutic effect on cardiac function. Over time the relief of wall stress reduces oxygen consumption and promotes healing. Moreover, various long-term therapeutic effects may be realized depending on the properties of the space-occupying agent, including combinations with other therapeutic materials. Specific cardiac conditions treatable by these systems and methods include, for example, dilated cardiomyopathy (with or without overt aneurismal formations), congestive heart failure, and ventricular arrhythmias. Patterns of distribution of space-occupying agent within the myocardium for global resizing may also be used or augmented to treat localized conditions such as myocardial infarctions, overt aneurysm of the ventricular wall as typically forms in response to large transmural myocardial infarctions, and mitral regurgitation due to a noncompliant mitral valve. These techniques may also be used to treat localized conditions that may not yet have progressed to cardiomyopathy.

First claim

The invention claimed is:

1. A method of treating a dilated chamber in a heart of a patient suffering chronic heart failure, comprising:
introducing a biocompatible space-occupying agent into a plurality of sites within a free myocardial wall of the dilated chamber to provide a therapeutic internal structure at each of the sites;
the therapeutic internal structures at the sites being non-contractile and distributed within the free myocardial wall with essentially no linkage with one another;
and further being distributed in a pattern generally throughout a region of the free myocardial wall along a circumference of the dilated chamber near a widest part of the dilated chamber between an apex and a base of the dilated chamber for globally reducing stress in the free myocardial wall of the dilated chamber, and shrinking the dilated chamber at the widest part thereof.

2. The method of claim 1 wherein the pattern comprises a first line generally extending circumferentially along a major portion of a free wall of the dilated chamber.

3. The method of claim 2 wherein the first line is generally about a dilated part of the dilated chamber.

4. The method of claim 3 wherein the pattern is limited to the first line.

5. The method of claim 2 wherein the first line comprises at least three substantially evenly spaced sites.

6. The method of claim 2 wherein the first line comprises at least three sites, wherein at least some of the sites are not substantially evenly spaced.

7. The method of claim 2 wherein the pattern comprises a second line generally extending circumferentially along a major portion of the free wall of the dilated chamber, generally parallel to and spaced-apart from the first line.

8. The method of claim 7 wherein the pattern comprises a third line generally extending circumferentially along a major portion of the free wall of the dilated chamber, generally parallel to and spaced-apart from the first and second lines.

9. The method of claim 1 wherein the dilated chamber is elongated, and the pattern comprises at least two generally parallel and spaced-apart lines generally extending longitudinally along a major portion of the free wall of the dilated chamber from near the base of the heart to near the apex of the heart.

10. The method of claim 9 wherein each of the lines comprises at least four substantially evenly spaced sites.

11. The method of claim 9 wherein each of the lines comprises at least four sites, wherein some of the sites are not substantially evenly spaced.

12. The method of claim 1 wherein the dilated chamber is elongated, and the pattern comprises at least three generally parallel and spaced-apart lines generally extending longitudinally along a major portion of the free wall of the dilated chamber from near the base of the heart to near the apex of the heart.

13. The method of claim 1 wherein the space-occupying agent comprises an injectable non-living material.

14. The method of claim 13 wherein the space-occupying agent further comprises living cells, growth factors, peptides, proteins, or any combination thereof.

15. The method of claim 1 wherein the space-occupying agent comprises an injectable self-gelling alginate hydrogel.

16. A method of treating a heart having a myocardium, comprising:
establishing a pattern of therapeutic internal structures for globally treating a ventricle of the heart of a patient suffering chronic heart failure, the pattern comprising at least one ventricular line extending generally throughout a region of a free myocardial wall of the ventricle along a circumference of the ventricle near a widest part of the ventricle between an apex and a base of the ventricle; and
introducing biocompatible material into the free myocardial wall in accordance with the pattern to form the therapeutic internal structures;
the therapeutic internal structures being distributed in the free myocardial wall with essentially no linkage with one another and in accordance with the pattern for globally reducing stress in the free myocardial wall and reducing systolic volume of the ventricle.

17. The method of claim 16 wherein the pattern further comprises at least one elongated line generally extending from near the base of the ventricle to near the apex of the ventricle.

18. The method of claim 16 further comprising:
identifying an area of a heart disorder in the myocardium;
wherein the pattern establishing step comprises establishing the pattern to have at least one intersection with the area of the heart disorder.

19. The method of claim 16 further comprising:
identifying an area of a heart disorder in the myocardium;
wherein the pattern establishing step comprises establishing the pattern to have a plurality of lines; and
wherein the area of the heart disorder is disposed between at least two of the lines.

20. The method of claim 16 wherein the biocompatible material comprises an injectable self-gelling alginate hydrogel.

21. A method of treating a dilated left ventricle in a heart of a patient, comprising:
introducing a biocompatible space-occupying agent into a plurality of sites within a free myocardial wall of the dilated left ventricle to provide a therapeutic internal structure at each of the sites;
the therapeutic internal structures at the sites being non-contractile and distributed within the free myocardial wall with essentially no linkage with one another;
and further being distributed in a pattern of one line which circumferentially spans around a periphery of the heart including injection sites in a series of 3-7 locations.

Assignees

• Sabbah Hani N
• Lee Randall J
• Hinson Andrew G
• Univ California
• Cardiopolymers Inc
• Ford Henry Health System

Inventors

• Sabbah Hani N
• Lee Randall J
• Hinson Andrew G

Classifications

• A61L27/20

  Polysaccharides · CPC title

• A61L27/3873

  Muscle tissue, e.g. sphincter · CPC title

• A61K9/0024

  Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L) · CPC title

• A61M5/178

  Syringes · CPC title

• A61L2400/06

  Flowable or injectable implant compositions · CPC title