Intramyocardial patterning for treating localized anomalies of the heart
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.
1 . A method of treating a heart having a myocardium, comprising:
identifying an area of a heart disorder in the myocardium;
establishing a pattern of intramyocardial supportive regions for encompassing the area of the heart disorder and portions of surrounding normal tissue of the myocardium; and
introducing biocompatible material into the myocardium in accordance with the pattern and to a therapeutically effective extent to form the intramyocardial supportive regions.
2 . The method of claim 1 wherein the pattern is aligned with muscle fibers of the surrounding normal tissue of the myocardium.
3 . The method of claim 1 wherein the pattern of intramyocardial supportive regions comprises at least an elongated line generally extending within the area of the heart disorder and between the area of the heart disorder and the surrounding normal tissue of the myocardium.
4 . The method of claim 3 wherein:
the biocompatible material is an injectate; and
the introducing step comprises injecting the injectate into a plurality of injection sites along the pattern at a predetermined depth in the myocardium, the pattern being aligned with muscle fibers of the surrounding normal tissue of the myocardium at the depth of the injection sites.
5 . The method of claim 3 wherein:
the biocompatible material is an implantable device; and
the introducing step comprises implanting the implantable device into a plurality of implant sites along the pattern at a predetermined depth in the myocardium, the pattern being aligned with muscle fibers of the surrounding normal tissue of the myocardium at the depth of the implant sites.
6 . The method of claim 3 wherein the pattern of intramyocardial supportive regions further comprises a first additional elongated line and a second additional elongated line generally disposed on opposite sides of the area of the heart disorder.
7 . The method of claim 6 wherein the elongated line and the first and second additional lines are substantially parallel.
8 . The method of claim 1 wherein the pattern of intramyocardial supportive regions comprises a first elongated line and a second elongated line generally disposed on opposite sides of the area of the heart disorder.
9 . The method of claim 1 wherein the pattern of intramyocardial supportive regions comprises an irregular distribution of injection sites.
10 . The method of claim 1 wherein the pattern of intramyocardial supportive regions comprises a regular distribution of injection sites.
11 . The method of claim 1 wherein the heart disorder identifying step comprises mapping the myocardium to identify the heart disorder.
12 . The method of claim 1 wherein the heart disorder identifying step comprises imaging the myocardium to identify the heart disorder.
13 . The method of claim 1 wherein the heart disorder is an aneurysm.
14 . The method of claim 1 wherein the heart disorder is a myocardial infarction.
15 . The method of claim 1 wherein the heart disorder is mitral regurgitation.
16 . The method of claim 1 wherein the biocompatible material comprises a biocompatible polymer in combination with living cells, growth factors, peptides, proteins, or any combination thereof.
17 . The method of claim 1 wherein the biocompatible material comprises fibrin sealant.
18 . The method of claim 1 wherein the biocompatible material comprises alginate.
19 . The method of claim 1 wherein the biocompatible material comprises polyethylene glycol.
20 . The method of claim 1 wherein the biocompatible material comprises injectable portions and implantable portions.
21 . A method of treating a heart having a myocardium, comprising:
establishing a pattern of intramyocardial supportive regions for treating a structure of the heart, the pattern encompassing at least part of the area of the heart structure; and
introducing biocompatible material into the myocardium in accordance with the pattern and to a therapeutically effective extent to form the intramyocardial supportive regions.
22 . The method of claim 21 wherein:
the heart disorder is mitral regurgitation; and
the pattern comprises at least one circumferentially-extending ventricular line proximate to a mitral valve annulus of the heart.
23 . A method of treating a heart having a myocardium, comprising:
establishing a pattern of intramyocardial supportive regions for treating an atrium of the heart; and
introducing biocompatible material into myocardial tissue of the heart in accordance with the pattern to form the intramyocardial supportive regions.
24 . The method of claim 23 wherein the pattern comprises at least one line encircling pulmonary veins of the heart.
25 . The method of claim 23 wherein the pattern comprises at least one line extending from pulmonary veins of the heart to a mitral annulus of the heart.
26 . The method of claim 23 wherein the pattern is similar to a pattern used for a Maze procedure.
27 . The method of claim 23 wherein the pattern is similar to a pattern used for a Corridor procedure.
28 . A kit for treating a heart having a myocardium, comprising:
means for establishing a pattern of intramyocardial supportive regions for encompassing a area of a heart disorder and portions of surrounding normal tissue of the myocardium; and
means for introducing biocompatible material into the myocardium in accordance with the pattern and to a therapeutically effective extent to form the intramyocardial supportive regions.
29 . A kit for treating a heart having a myocardium, comprising:
means for establishing a pattern of intramyocardial supportive regions for treating a structure of the heart, the pattern encompassing at least part of the area of the heart structure; and
means for introducing biocompatible material into the myocardium in accordance with the pattern and to a therapeutically effective extent to form the intramyocardial supportive regions.