Expandable cardiac harness for treating congestive heart failure

• US 7,276,022 B2
• Filed: 12/14/2004
• Issued: 10/02/2007
• Est. Priority Date: 03/10/2000
• Status: Expired due to Fees

• Current Assignee: Paracor Medical, Inc.
• Original Assignee: Paracor Medical, Inc.
• Inventors: Lau, Lilip, Hartigan, Bill
• Primary Examiner(s): Getzow; Scott M.
• Application Number:
  US11/012,833
• Publication Number:
  US 20050107661A1
• Time in Patent Office: 1,022 Days
• Field of Search: 128/898, 600 16- 18, 600/37, 607 4- 9
• US Class Current: 600/37
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8243 by induction
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• 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 60/438 the force acting on the blood contacting member being mechanical
• CPC Class Codes: A61M 60/873 specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
• CPC Class Codes: A61M 60/882 Devices powered by the patient, e.g. skeletal muscle powered devices
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: Y10T 29/49995 Shaping one-piece blank by removing material

Abstract

A cardiac harness for treating congestive heart failure is disclosed. The harness applies elastic, compressive reinforcement on the left ventricle to reduce deleterious wall tension and to resist shape change of the ventricle during the mechanical cardiac cycle. Rather than imposing a dimension beyond which the heart cannot expand, the harness provides no hard limit over the range of diastolic expansion of the ventricle. Instead, the harness follows the contour of the heart throughout diastole and continuously exerts gentle resistance to stretch. Also disclosed is a method of delivering the cardiac harness to the heart minimally invasively.

Claims

1. A method for attenuating remodeling of a heart, comprising:

mounting a cardiac harness on the heart, the cardiac harness applying a compressive force on the heart during at least a portion of a cardiac cycle;

decreasing wall stress on the left ventricle by action of the compressive force of the cardiac harness; and

attenuating expansion or remodeling of the heart as the cardiac harness applies compressive force on the heart during the at least a portion of the cardiac cycle.

2. The method of claim 1, wherein the cardiac harness mechanically resists size and shape changes in the heart.

3. The method of claim 1, wherein the cardiac harness mechanically resists size and shape changes in the heart after an acute myocardial infarction.

4. The method of claim 1, wherein the compressive force of the cardiac harness decreases left ventricular size and reshapes the left ventricle.

5. The method of claim 4, wherein as the left ventricle decreases in size and reshapes, the compressive force of the cardiac harness on the heart automatically decreases.

6. The method of claim 1, wherein the compressive force of the cardiac harness on the heart is less than 10 mm Hg.

7. The method of claim 1, wherein the compressive force of the cardiac jacket on the heart is in the range of compressive force of native pericardium.

8. The method of claim 7, wherein the compressive force of the cardiac jacket on the heart is in the range of 3 to 4 mm Hg.

9. The method of claim 1, wherein the compressive force on the heart is applied during diastole.

10. The method of claim 1, wherein the compressive force on the heart is applied during systole.

11. The method of claim 1, wherein the compressive force on the heart applied by the cardiac harness counteracts paradoxical bulging of an infarct region occurring in dyskinetic and aneurysmal hearts during systole.

12. The method of claim 1, wherein the compressive force on the heart applied by the cardiac harness attenuates dyssynchrony.

13. The method of claim 1, wherein the compressive force on the heart applied by the cardiac harness attenuates hypokinesis.

14. The method of claim 1, wherein the compressive force on the heart applied by the cardiac harness attenuates akinesis.

15. The method of claim 1, wherein the compressive force on the heart applied by the cardiac harness attenuates dyskinesis.

16. The method of claim 1, wherein after an acute myocardial infarction, applying the compressive force during diastole and systole.

17. The method of claim 16, wherein the compressive force on the heart applied by the cardiac harness counteracts paradoxical bulging of an infarct region occurring in dyskinetic and aneurysmal hearts during systole.

18. The method of claim 16, wherein the compressive force on the heart applied by the cardiac harness attenuates dyssynchrony.

19. The method of claim 16, wherein the compressive force on the heart applied by the cardiac harness attenuates hypokinesis.

20. The method of claim 16, wherein the compressive force on the heart applied by the cardiac harness attenuates akinesis.

21. The method of claim 16, wherein the compressive force on the heart applied by the cardiac harness attenuates dyskinesis.

22. The method of claim 16, wherein the compressive force on the heart applied by the cardiac harness attenuates infarct expansion.

23. The method of claim 1, wherein the cardiac harness is mounted on a beating heart.

24. The method of claim 23, wherein the cardiac harness is delivered to the heart by minimally invasive access.

25. The method of claim 24, wherein the cardiac harness is delivered to the heart through a small incision in the pericardium.

26. The method of claim 1, wherein prior to mounting the cardiac harness on the heart, performing a coronary artery bypass grafting procedure on the heart.

27. The method of claim 1, wherein prior to mounting the cardiac harness on the heart, repairing or replacing a heart valve.

28. The method of claim 1, wherein the cardiac harness is integrated with an implantable pacemaker or an implantable cardiac defibrillator.

29. The method of claim 1, wherein the cardiac harness is mounted during coronary artery bypass grafting.

30. The method of claim 1, wherein after an acute myocardial infarction, performing a coronary artery bypass grafting procedure and mounting the cardiac harness on the heart.

31. The method of claim 1, wherein the compressive force on the heart applied by the cardiac harness attenuates hyperkinesis.

32. The method of claim 1, wherein after an acute myocardial infarction, mounting the cardiac harness on the heart and performing a coronary artery bypass procedure.

33. The method of claim 1, wherein after an acute myocardial infarction, performing a coronary artery bypass grafting procedure, and mounting the cardiac harness, integrated with an implantable pacemaker or a defibrillator, on the heart.

34. The method of claim 1, wherein a coronary artery bypass grafting procedure is performed and the mounting of the cardiac harness includes integrating a pacemaker or defibrillator with the cardiac harness.

35. A method for attenuating remodeling of a heart, comprising:

after a patient experiences an acute myocardial infarction;

mounting a cardiac harness on the heart, the cardiac harness applying a compressive force on the heart during at least a portion of a cardiac cycle;

decreasing wall stress on the left ventricle by action of the compressive force of the cardiac harness; and

attenuating expansion or remodeling of the heart as the cardiac harness applies compressive force on the heart during the at least a portion of the cardiac cycle.

36. The method of claim 35, wherein the cardiac harness mechanically resists size and shape changes in the heart.

37. The method of claim 35, wherein the compressive force of the cardiac harness decreases left ventricular size and reshapes the left ventricle.

38. The method of claim 35, wherein as the left ventricle decreases in size and reshapes, the compressive force of the cardiac harness on the heart automatically decreases.

39. The method of claim 35, wherein the compressive force of the cardiac harness on the heart is less than 10 mm Hg.

40. The method of claim 35, wherein the compressive force of the cardiac jacket on the heart is in the range of compressive force of native pericardium.

41. The method of claim 40, wherein the compressive force of the cardiac jacket on the heart is in the range of 3 to 4 mm Hg.

42. The method of claim 35, wherein the compressive force on the heart is applied during diastole.

43. The method of claim 35, wherein the compressive force on the heart is applied during systole.

44. The method of claim 35, wherein the compressive force on the heart applied by the cardiac harness counteracts paradoxical bulging of an infarct region occurring in dyskinetic and aneurysmal hearts during systole.

45. The method of claim 35, wherein the compressive force on the heart applied by the cardiac harness attenuates dyssynchrony.

46. The method of claim 35, wherein the compressive force on the heart applied by the cardiac harness attenuates hypokinesis.

47. The method of claim 35, wherein the compressive force on the heart applied by the cardiac harness attenuates akinesis.

48. The method of claim 35, wherein the compressive force on the heart applied by the cardiac harness attenuates dyskinesis.

49. The method of claim 35, wherein after the acute myocardial infarction, applying the compressive force during diastole and systole.

50. The method of claim 49, wherein the compressive force on the heart applied by the cardiac harness counteracts paradoxical bulging of an infarct region occurring in dyskinetic and aneurysmal hearts during systole.

51. The method of claim 49, wherein the compressive force on the heart applied by the cardiac harness attenuates dyssynchrony.

52. The method of claim 49, wherein the compressive force on the heart applied by the cardiac harness attenuates hypokinesis.

53. The method of claim 49, wherein the compressive force on the heart applied by the cardiac harness attenuates akinesis.

54. The method of claim 49, wherein the compressive force on the heart applied by the cardiac harness attenuates dyskinesis.

55. The method of claim 49, wherein the compressive force on the heart applied by the cardiac harness attenuates infarct expansion.

56. The method of claim 35, wherein the cardiac harness is mounted on a beating heart.

57. The method of claim 56, wherein the cardiac harness is delivered to the heart by minimally invasive access.

58. The method of claim 57, wherein the cardiac harness is delivered to the heart through a small incision in the pericardium.

59. The method of claim 35, wherein prior to mounting the cardiac harness on the heart, performing a coronary artery bypass grafting procedure on the heart.

60. The method of claim 35, wherein prior to mounting the cardiac harness on the heart, repairing or replacing a heart valve.

61. The method of claim 35, wherein the cardiac harness is integrated with an implantable pacemaker or an implantable cardiac defibrillator.

62. The method of claim 35, wherein the cardiac harness is mounted during coronary artery bypass grafting.

63. The method of claim 35, wherein after the acute myocardial infarction, performing a coronary artery bypass grafting procedure and mounting the cardiac harness on the heart.

64. The method of claim 35, wherein the compressive force on the heart applied by the cardiac harness attenuates hyperkinesis.

65. The method of claim 35, wherein after the acute myocardial infarction, mounting the cardiac harness on the heart and performing a coronary artery bypass grafting procedure.

66. The method of claim 35, wherein after the acute myocardial infarction, performing a coronary artery bypass grafting procedure, and mounting the cardiac harness, integrated with an implantable pacemaker or a defibrillator, on the heart.

67. The method of claim 36, wherein a coronary artery bypass grafting procedure is performed and the mounting of the cardiac harness includes integrating a pacemaker or defibrillator with the cardiac harness.

68. A method for attenuating remodeling of a heart, comprising:

mounting a cardiac harness on the heart, the cardiac harness having elastic hinges for applying a compressive force on the heart during at least a portion of a cardiac cycle;

decreasing wall stress on the left ventricle by action of the compressive force of the elastic hinges; and

attenuating expansion or remodeling of the heart as the elastic hinges of the cardiac harness apply compressive force on the heart during the at least a portion of the cardiac cycle.

69. The method of claim 68, wherein the elastic hinges mechanically resist size and shape changes in the heart.

70. The method of claim 68, wherein the elastic hinges mechanically resist size and shape changes in the heart after an acute myocardial infarction.

71. The method of claim 68, wherein the compressive force of the elastic hinges decreases left ventricular size and reshapes the left ventricle.

72. The method of claim 71, wherein as the left ventricle decreases in size and reshapes, the compressive force of the cardiac harness on the heart automatically decreases.

73. The method of claim 68, wherein the compressive force of the elastic hinges on the heart is less than 10 mm Hg.

74. The method of claim 68, wherein the compressive force of the elastic hinges on the heart is in the range of compressive force of native pericardium.

75. The method of claim 74, wherein the compressive force of the elastic hinges on the heart is in the range of 3 to 4 mm Hg.

76. The method of claim 68, wherein the compressive force on the heart is applied during diastole.

77. The method of claim 68, wherein the compressive force on the heart is applied during systole.

78. The method of claim 68, wherein the compressive force on the heart applied by the elastic hinges counteracts paradoxical bulging of an infarct region occurring in dyskinetic and aneurysmal hearts during systole.

79. The method of claim 68, wherein the compressive force on the heart applied by the elastic hinges attenuates dyssynchrony.

80. The method of claim 68, wherein the compressive force on the heart applied by the elastic hinges attenuates hypokinesis.

81. The method of claim 68, wherein the compressive force on the heart applied by the elastic hinges attenuates akinesis.

82. The method of claim 68, wherein the compressive force on the heart applied by the elastic hinges attenuates dyskmesis.

83. The method of claim 76, wherein after an acute myocardial infarction, applying the compressive force during diastole and systole.

84. The method of claim 83, wherein the compressive force on the heart applied by the elastic hinges counteracts paradoxical bulging of an infarct region occurring in dyskinetic and aneurysmal hearts during systole.

85. The method of claim 83, wherein the compressive force on the heart applied by the cardiac harness attenuates dyssynchrony.

86. The method of claim 83, wherein the compressive force on the heart applied by the cardiac harness attenuates hypokinesis.

87. The method of claim 83, wherein the compressive force on the heart applied by the cardiac harness attenuates akinesis.

88. The method of claim 83, wherein the compressive force on the heart applied by the cardiac harness attenuates dyskinesis.

89. The method of claim 83, wherein the compressive force on the heart applied by the elastic hinges attenuates infarct expansion.

90. The method of claim 68, wherein the cardiac harness is mounted on a beating heart.

91. The method of claim 90, wherein the cardiac harness is delivered to the heart by minimally invasive access.

92. The method of claim 68, wherein the cardiac harness is delivered to the heart through a small incision in the pericardium.

93. The method of claim 68, wherein prior to mounting the cardiac harness on the heart, performing a coronary artery bypass grafting procedure on the heart.

94. The method of claim 68, wherein prior to mounting the cardiac harness on the heart, repairing or replacing a heart valve.

95. The method of claim 68, wherein the cardiac harness is integrated with an implantable pacemaker or an implantable cardiac defibrillator.

96. The method of claim 68, wherein the cardiac harness is mounted during coronary artery bypass grafting.

97. The method of claim 68, wherein after an acute myocardial infarction, performing a coronary artery bypass grafting procedure and mounting the cardiac harness on the heart.

98. The method of claim 68, wherein the compressive force on the heart applied by the elastic hinges attenuates hyperkinesis.

99. The method of claim 68, wherein after an acute myocardial infarction, mounting the cardiac harness on the heart and performing a coronary artery bypass grafting procedure.

100. The method of claim 68, wherein after an acute myocardial infarction, performing a coronary artery bypass grafting procedure, and mounting the cardiac harness, integrated with an implantable pacemaker or a defibrillator, on the heart.

101. The method of claim 68, wherein a coronary artery bypass grafting procedure is performed and the mounting of the cardiac harness includes integrating a pacemaker or defibrillator with the cardiac harness.

102. A method for preventing remodeling of a heart, comprising:

mounting a cardiac harness on the heart, the cardiac harness applying a compressive force on the heart during at least a portion of a cardiac cycle;

decreasing wall stress on the left ventricle by action of the compressive force of the cardiac harness; and

preventing expansion or remodeling of the heart as the cardiac harness applies compressive force on the heart during the at least a portion of the cardiac cycle.

103. The method of claim 102, wherein the cardiac harness mechanically resists size and shape changes in the heart.

104. The method of claim 102, wherein the cardiac harness mechanically resists size and shape changes in the heart after an acute myocardial infarction.

105. The method of claim 102, wherein the compressive force of the cardiac harness decreases left ventricular size and reshapes the left ventricle.

106. The method of claim 105, wherein as the left ventricle decreases in size and reshapes, the compressive force of the cardiac harness on the heart automatically decreases.

107. The method of claim 102, wherein the compressive force of the cardiac harness on the heart is less than 10 mm Hg.

108. The method of claim 102, wherein the compressive force of the cardiac jacket on the heart is in the range of compressive force of native pericardium.

109. The method of claim 108, wherein the compressive force of the cardiac jacket on the heart is in the range of 3 to 4 mm Hg.

110. The method of claim 102, wherein the compressive force on the heart is applied during diastole.

111. The method of claim 102, wherein the compressive force on the heart is applied during systole.

112. The method of claim 102, wherein the compressive force on the heart applied by the cardiac harness counteracts paradoxical bulging of an infarct region occurring in dyskinetic and aneurysmal hearts during systole.

113. The method of claim 102, wherein the compressive force on the heart applied by the cardiac harness attenuates dyssynchrony.

114. The method of claim 102, wherein the compressive force on the heart applied by the cardiac harness attenuates hypokinesis.

115. The method of claim 102, wherein the compressive force on the heart applied by the cardiac harness attenuates akinesis.

116. The method of claim 102, wherein the compressive force on the heart applied by the cardiac harness attenuates dyskinesis.

117. The method of claim 102, wherein after an acute myocardial infarction, applying the compressive force during diastole and systole.

118. The method of claim 117, wherein the compressive force on the heart applied by the cardiac harness counteracts paradoxical bulging of an infarct region occurring in dyskinetic and aneurysmal hearts during systole.

119. The method of claim 117, wherein the compressive force on the heart applied by the cardiac harness attenuates dyssynchrony.

120. The method of claim 117, wherein the compressive force on the heart applied by the cardiac harness attenuates hypokinesis.

121. The method of claim 117, wherein the compressive force on the heart applied by the cardiac harness attenuates akinesis.

122. The method of claim 117, wherein after an acute myocardial infarction, applying the compressive force during diastole and systole.

123. The method of claim 117, wherein the compressive force on the heart applied by the cardiac harness attenuates infarct expansion.

124. The method of claim 102, wherein the compressive force on the heart applied by the cardiac harness attenuates infarct expansion.

125. The method of claim 102, wherein the cardiac harness is mounted on a beating heart.

126. The method of claim 125, wherein the cardiac harness is delivered to the heart by minimally invasive access.

127. The method of claim 126, wherein the cardiac harness is delivered to the heart through a small incision in the pericardium.

128. The method of claim 102, wherein prior to mounting the cardiac harness on the heart, performing a coronary artery bypass grafting procedure on the heart.

129. The method of claim 102, wherein prior to mounting the cardiac harness on the heart, repairing or replacing a heart valve.

130. The method of claim 102, wherein the cardiac harness is integrated with an implantable pacemaker or an implantable cardiac defibrillator.

131. The method of claim 102, wherein the cardiac harness is mounted during coronary artery bypass grafting.

132. The method of claim 102, wherein after an acute myocardial infarction, performing a coronary artery bypass grafting procedure and mounting the cardiac harness on the heart.

133. The method of claim 102, wherein the compressive force on the heart applied by the cardiac harness attenuates hyperkinesis.

134. The method of claim 102, wherein after an acute myocardial infarction, mounting the cardiac harness on the heart and performing a coronary artery bypass grafting procedure.

135. The method of claim 102, wherein after an acute myocardial infarction, performing a coronary artery bypass grafting procedure, and mounting the cardiac harness, integrated with an implantable pacemaker or a defibrillator, on the heart.

136. The method of claim 102, wherein a coronary artery bypass grafting procedure is performed and the mounting of the cardiac harness includes integrating a pacemaker or defibrillator with the cardiac harness.

137. A method for attenuating remodeling of a heart, comprising:

mounting a cardiac harness on the heart, the cardiac harness applying a compressive force on the heart during at least a portion of a cardiac cycle;

decreasing wall stress on the left ventricle and the right ventricle by action of the compressive force of the cardiac harness; and

attenuating expansion or remodeling of the heart as the cardiac harness applies compressive force on the heart during the at least a portion of the cardiac cycle.

138. The method of claim 137, wherein the cardiac harness mechanically resists size and shape changes in the heart.

139. The method of claim 137, wherein the cardiac harness mechanically resists size and shape changes in the heart after an acute myocardial infarction.

140. The method of claim 137, wherein the compressive force of the cardiac harness decreases left and right ventricular size and reshapes the left and right ventricles.

141. The method of claim 140, wherein as the left and right ventricles decrease in size and reshapes, the compressive force of the cardiac harness on the heart automatically decreases.

142. The method of claim 137, wherein the compressive force of the cardiac harness on the heart is less than 10 mm Hg.

143. The method of claim 137, wherein the compressive force of the cardiac jacket on the heart is in the range of compressive force of native pericardium.

144. The method of claim 143, wherein the compressive force of the cardiac jacket on the heart is in the range of 3 to 4 mm Hg.

145. The method of claim 137, wherein the compressive force on the heart is applied during diastole.

146. The method of claim 137, wherein the compressive force on the heart is applied during systole.

147. The method of claim 137, wherein the compressive force on the heart applied by the cardiac harness counteracts paradoxical bulging of an infarct region occurring in dyskinetic and aneurysmal hearts during systole.

148. The method of claim 137, wherein the compressive force on the heart applied by the cardiac harness attenuates dyssynchrony.

149. The method of claim 137, wherein the compressive force on the heart applied by the cardiac harness attenuates hypokinesis.

150. The method of claim 137, wherein the compressive force on the heart applied by the cardiac harness attenuates akmesis.

151. The method of claim 137, wherein the compressive force on the heart applied by the cardiac harness attenuates dyskinesis.

152. The method of claim 137, wherein after an acute myocardial infarction, applying the compressive force during diastole and systole.

153. The method of claim 152, wherein the compressive force on the heart applied by the cardiac harness counteracts paradoxical bulging of an infarct region occurring in dyskinetic and aneurysmal hearts during systole.

154. The method of claim 152, wherein the compressive force on the heart applied by the cardiac harness attenuates dyssynchrony.

155. The method of claim 152, wherein the compressive force on the heart applied by the cardiac harness attenuates hypokinesis.

156. The method of claim 152, wherein the compressive force on the heart applied by the cardiac harness attenuates akinesis.

157. The method of claim 152, wherein the compressive force on the heart applied by the cardiac harness attenuates dyskinesis.

158. The method of claim 152, wherein the compressive force on the heart applied by the cardiac harness attenuates infarct expansion.

159. The method of claim 137, wherein the cardiac harness is mounted on a beating heart.

160. The method of claim 159, wherein the cardiac harness is delivered to the heart by minimally invasive access.

161. The method of claim 160, wherein the cardiac harness is delivered to the heart through a small incision in the pericardium.

162. The method of claim 137, wherein prior to mounting the cardiac harness on the heart, performing a coronary artery bypass grafting procedure on the heart.

163. The method of claim 137, wherein prior to mounting the cardiac harness on the heart, repairing or replacing a heart valve.

164. The method of claim 137, wherein the cardiac harness is integrated with an implantable pacemaker or an internal cardiac defibrillator.

165. The method of claim 137, wherein the cardiac harness is mounted during coronary artery bypass grafting.

166. The method of claim 137, wherein after an acute myocardial infarction, performing a coronary artery bypass grafting procedure and mounting the cardiac harness on the heart.

167. The method of claim 137, wherein the compressive force on the heart applied by the cardiac harness attenuates hyperkinesis.

168. The method of claim 137, wherein after an acute myocardial infarction, mounting the cardiac harness on the heart and performing a coronary artery bypass grafting procedure.

169. The method of claim 137, wherein after an acute myocardial infarction, performing a coronary artery bypass grafting procedure, and mounting the cardiac harness, integrated with an implantable pacemaker or a defibrillator, on the heart.

170. The method of claim 137, wherein a coronary artery bypass grafting procedure is performed and the mounting of the cardiac harness includes integrating a pacemaker or defibrillator with the cardiac harness.