Intramyocardial patterning for global cardiac resizing and reshaping

Patent metadata

Field	Value
Publication number	US-9375313-B2
Application number	US-89996207-A
Country	US
Kind code	B2
Filing date	Sep 7, 2007
Priority date	Sep 8, 2006
Publication date	Jun 28, 2016
Grant date	Jun 28, 2016

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. These techniques may also be used to treat localized conditions, whether or not they have progressed to cardiomyopathy.

First claim

The invention claimed is:

1. A method of treating chronic heart failure, comprising,
injecting a dose of biocompatible self-gelling alginate hydrogel agent into at least three injection sites within a free myocardial wall of a dilated left ventricle of a heart suffering dilated congestive cardiomyopathy to complete gelling in situ among contracting cardiac muscle fibers and within the free myocardial wall at each of the injection sites, the self-gelling alginate hydrogel agent having a pre-gel viscosity suitable for injecting, and further being non-contractile in situ and having a post-gel stiffness in situ equal to or slightly greater than normal myocardium;
the injection sites having a distribution within the free myocardial wall outside of areas of aneurysm and myocardial infarction and along anterior, anterior lateral, and posterior lateral surfaces of the heart and throughout only a circumferential region near a widest part of the dilated left ventricle between an apex and base of the dilated left ventricle such that the self-gelling alginate hydrogel agent at the injection sites have essentially no linkage with one another, the distribution being configured to lead to points of decreased wall stress generally throughout the circumferential region, to globally reduce stress in the free myocardial wall of the dilated left ventricle and to shrink the dilated left ventricle at the widest part thereof to reshape the left ventricle to a more physiological ellipsoid shape;
the dose being an effective amount for reducing systolic volume of the dilated left ventricle, and improving function d the dilated left ventricle; and
wherein the at least three injection sites only comprise anterior, anterior lateral and posterior lateral surfaces of the heart.

2. The method of claim 1 wherein the injection sites are distributed only in one circumferential line.

3. The method of claim 2 wherein at least five injection sites are evenly distributed along the circumferential line.

4. The method of claim 2 wherein at least five injection sites are unevenly distributed along the circumferential line.

5. The method of claim 1 wherein the injection sites are distributed in two parallel circumferential lines.

6. The method of claim 1 wherein the self-gelling alginate hydrogel agent comprises alginate in combination with living cells, growth factors, peptides, proteins, or any combination thereof.

7. A method of treating chronic heart failure: to achieve a clinically defined endpoint defined by an ellipsoid remodeling of a subject heart, comprising, in combination the steps of:
injecting a biocompatible self-gelling alginate hydrogel agent into at least three injection sites within a free myocardial wall of a dilated left ventricle of a heart, the self-gelling alginate hydrogel agent having a pre-gel viscosity suitable for injecting, and further being non-contractile in situ and having a post-gel stiffness in situ equal to or slightly greater than normal myocardium:
the injection sites having a distribution along anterior, anterior lateral and posterior lateral surfaces of the heart and throughout only a circumferential region near a widest part of the dilated left ventricle between an apex and base of the dilated left ventricle and within the free myocardial wall such that the biocompatible self-gelling alginate hydrogel agent at the injection sites have essentially no linkage with one another, the distribution being configured to lead to points of decreased wall stress generally through the circumferential region, to globally reduce stress in the free myocardial wall of the dilated left ventricle, and to effect a global resizing and reshaping of the left ventricle to a more physiological ellipsoid shape;
the biocompatible self-gelling alginate hydrogel agent being injected into the injection sites in an amount effective to reduce end-diastolic volume and end-systolic volume and increase ejection fraction at the time of treatment for at least 12 weeks; and
wherein the at least three injection sites only comprise anterior, anterior lateral and posterior lateral surfaces of the heart.

8. The method of claim 7 wherein the injection sites are distributed only in one circumferential line.

9. The method of claim 8 wherein at least five injection sites are evenly distributed along the circumferential line.

10. The method of claim 8 wherein at least five injection sites are unevenly distributed along the circumferential line.

11. The method of claim 7 wherein the injection sites are distributed in two parallel circumferential lines.

12. The method of claim 7 wherein the self-gelling alginate agent comprises alginate in combination with living cells, growth factors, peptides, proteins, or any combination thereof.

Assignees

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

Inventors

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

Classifications

• A61L27/3873

  Muscle tissue, e.g. sphincter · CPC title

• A61F2002/249

  Device completely embedded in the heart wall · CPC title

• A61F2250/0067

  Means for introducing or releasing pharmaceutical products into the body · CPC title

• A61M5/178

  Syringes · CPC title

• A61L27/52

  Hydrogels or hydrocolloids · CPC title