Ventricular restoration shaping apparatus and method of use

• US 6,994,093 B2
• Filed: 05/24/2001
• Issued: 02/07/2006
• Est. Priority Date: 02/28/2001
• Status: Expired due to Fees

• Current Assignee: CMI Holding Co. Inc. (Chase Medical Technologies LP)
• Original Assignee: Chase Medical LP
• Inventors: Murphy, Gregory, Suresh, Mitta, Davis, Albert
• Primary Examiner(s): Lewis, Ralph A.
• Application Number:
  US09/864,510
• Publication Number:
  US 20020133143A1
• Time in Patent Office: 1,720 Days
• Field of Search: 606/151, 128/898, 600/16, 600/37, 600/587, 623/3.1, 335/12
• US Class Current: 128/898
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0493 Protective devices for suturing, i.e. for protecting the patient's organs or the operator
• CPC Class Codes: A61B 17/4241 Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/0237 for heart surgery
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

Apparatuses and methods are provided to reconstruct an enlarged left ventricle of a human heart, using a shaper, having a size and shape substantially equal to the size and shape of an appropriate left ventricle, wherein the shaper is adapted to be temporarily placed into the enlarged left ventricle during a surgical procedure. Another aspect of one embodiment comprises a ventricular patch adapted for placement into the left ventricle of a heart made from a sheet of biocompatible material, and having a plurality of markings coupled to the sheet, wherein the markings are configured in distinct patterns for post operatively evaluating movement of the patch. In another aspect of one embodiment, a device is presented, comprising of a handle and a sizing template adapted to be coupled to the handle. Such components are also presented as a kit for use during ventricular restoration surgery.

Claims

1. A method for reconstructing an enlarged left ventricle of a human heart, comprising:

opening the enlarged left ventricle;

placing a shaper into the enlarged left ventricle, the shaper having a size and shape substantially equal to the size and shape of an appropriate left ventricle;

reforming the enlarged left ventricle over the shaper;

removing the shaper from the enlarged left ventricle; and

suturing a patch to an interior of the left ventricle closing the opening, such that the enlarged left ventricle is reconstructed into a shape and volume of an appropriate left ventricle.

2. The method of claim 1, wherein the reforming step further comprises:

pulling the enlarged left ventricle over the shaper;

suturing the left ventricle such that an interior surface of the left ventricle substantially conforms to the shape of the shaper; and

partially closing the opening.

3. The method of claim 1, further comprising excluding scar tissue from the viable tissue.

4. The method of claim 1, further comprising:

determining a demarkation line between non-viable tissue and viable tissue;

excluding some of the non-viable tissue;

placing at least one suture along the demarkation line; and

pulling the suture such that the left ventricle is pulled around the shaper.

5. The method of claim 4, wherein the determining of the demarkation line further comprises engaging a wall of the left ventricle of a beating heart to sense tactile feedback.

6. The method of claim 4, wherein the determining of the demarkation line further comprises visually determining akinetic and viable tissue.

7. The method of claim 4, wherein the determining of the demarkation line further comprises detecting electrical pulses from the viable tissue.

8. The method of claim 4, wherein the closing step comprises suturing a patch along the at least one demarkation line.

9. A method for reshaping a left ventricle of a human heart, comprising:

positioning a shaper in the left ventricle;

reshaping at least a portion of the left ventricle about the shaper such that at least a portion of the left ventricle substantially conforms to a predetermined shape of the shaper; and

suturing a patch to an interior of the left ventricle.

10. The method of claim 9, further comprising excluding scar tissue from viable tissue.

11. The method of claim 9, wherein at least a portion of the left ventricle substantially corresponds to the predetermined shape of the shaper.

12. The method of claim 9, further comprising:

determining a demarkation line between non-viable tissue and viable tissue;

excluding at least some of the non-viable tissue;

placing at least one suture along at least a portion of the demarkation line; and

pulling the suture such that the left ventricle is pulled around the shaper.

13. The method of claim 12, wherein the determining of the demarkation line further comprises engaging a wall of the left ventricle of a beating heart to sense tactile feedback.

14. The method of claim 12, wherein the determining of the demarkation line further comprises visually determining akinetic and viable tissue.

15. The method of claim 12, wherein the determining of the demarkation line further comprises detecting electrical pulses from viable tissue.

16. The method of claim 12, further comprising suturing a patch along at least a portion of one of the demarkation lines.

17. The method of claim 9, wherein the shaper has a short axis and a long axis.

18. The method of claim 9, wherein the shaper has a short axis and a long axis, and wherein the ratio of the short axis to the long axis is about 0.3 to about 0.7.

19. The method of claim 9, wherein the shaper is substantially ellipsoid in shape.

20. The method of claim 9, wherein the shaper is substantially conical in shape.

21. The method of claim 9, wherein the shaper is substantially pear shaped.

22. The method of claim 9, wherein the shaper is substantially tear drop shaped.

23. The method of claim 9, wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper.

24. The method of claim 9, wherein the reshaping comprises using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper.

25. The method of claim 9, further comprising demarking between non-viable tissue and viable tissue of the left ventricle.

26. The method of claim 9, wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper and using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper.

27. The method of claim 9, further comprising demarking between non-viable tissue and viable tissue of the left ventricle, and wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper and using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper.

28. The method of claim 9, wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper and using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper, and further comprising attaching a patch to at least a portion of the left ventricle.

29. The method of claim 9, further comprising excluding at least some of the non-viable tissue of the left ventricle.

30. The method of claim 9, further comprising:

excluding at least some of the non-viable tissue;

placing at least one suture along at least a portion of the demarkation line; and

pulling the suture such that the left ventricle is pulled around the shaper.

31. The method of claim 30, further comprising attaching a patch along at least a portion of one of the demarkation lines.

32. The method of claim 30, further comprising suturing a patch along at least a portion of one of the demarkation lines.

33. A method for reshaping a left ventricle of a heart, comprising:

positioning a shaper in the left ventricle;

positioning a gel in a hollow of the shaper to expand the shaper to a predetermined shape;

reshaping at least a portion of the left ventricle about the shaper such that at least a portion of the left ventricle substantially conforms to the predetermined shape of the shaper; and

suturing a patch to an interior of the left ventricle.

34. The method of claim 33, further comprising excluding scar tissue from viable tissue.

35. The method of claim 33, wherein at least a portion of the left ventricle substantially corresponds to the predetermined shape of the shaper.

36. The method of claim 33, further comprising:

determining a demarkation line between non-viable tissue and viable tissue;

excluding at least some of the non-viable tissue;

placing at least one suture along at least a portion of the demarkation line; and

pulling the suture such that the left ventricle is pulled around the shaper.

37. The method of claim 36, wherein the determining of the demarkation line further comprises engaging a wall of the left ventricle of a beating heart to sense tactile feedback.

38. The method of claim 36, wherein the determining of the demarkation line further comprises visually determining akinetic and viable tissue.

39. The method of claim 36, wherein the determining of the demarkation line further comprises detecting electrical pulses from viable tissue.

40. The method of claim 36, further comprising suturing a patch along at least a portion of one of the demarkation lines.

41. A method for reshaping a left ventricle of a human heart, comprising:

positioning a shaper in the left ventricle;

expanding an expander positioned in a hollow of the shaper to expand the shaper to a predetermined shape;

reshaping at least a portion of the left ventricle about the shaper such that at least a portion of the left ventricle substantially conforms to the predetermined shape of the shaper; and

excluding scar tissue from viable tissue.

42. The method of claim 41, further comprising suturing a patch to an interior of the left ventricle.

43. The method of claim 41, wherein at least a portion of the left ventricle substantially corresponds to the predetermined shape of the shaper.

44. The method of claim 41, further comprising:

determining a demarkation line between non-viable tissue and viable tissue;

excluding at least some of the non-viable tissue;

placing at least one suture along at least a portion of the demarkation line; and

pulling the suture such that the left ventricle is pulled around the shaper.

45. The method of claim 44, wherein the determining of the demarkation line further comprises engaging a wall of the left ventricle of a beating heart to sense tactile feedback.

46. The method of claim 44, wherein the determining of the demarkation line further comprises visually determining akinetic and viable tissue.

47. The method of claim 44, wherein the determining of the demarkation line further comprises detecting electrical pulses from viable tissue.

48. The method of claim 44, further comprising suturing a patch along at least a portion of one of the demarkation lines.

49. A method for reshaping a left ventricle of a human heart, comprising:

positioning a shaper in the left ventricle;

expanding an expander positioned in a hollow of the shaper to expand the shaper to a predetermined shape;

reshaping at least a portion of the left ventricle about the shaper such that at least a portion of the left ventricle substantially conforms to the predetermined shape of the shaper; and

suturing a patch to an interior of the left ventricle.

50. The method of claim 49, wherein at least a portion of the left ventricle substantially corresponds to the predetermined shape of the shaper.

51. The method of claim 49, further comprising:

determining a demarkation line between non-viable tissue and viable tissue;

excluding at least some of the non-viable tissue;

placing at least one suture along at least a portion of the demarkation line; and

pulling the suture such that the left ventricle is pulled around the shaper.

52. The method of claim 50, wherein the determining of the demarkation line further comprises engaging a wall of the left ventricle of a beating heart to sense tactile feedback.

53. The method of claim 51, wherein the determining of the demarkation line further comprises visually determining akinetic and viable tissue.

54. The method of claim 51, wherein the determining of the demarkation line further comprises detecting electrical pulses from viable tissue.

55. The method of claim 51, further comprising suturing a patch along at least a portion of one of the demarkation lines.

56. A method for reshaping a left ventricle of a human heart, comprising:

positioning a shaper in the left ventricle;

expanding an expander positioned in a hollow of the shaper to expand the shaper to a predetermined shape;

reshaping at least a portion of the left ventricle about the shaper such that at least a portion of the left ventricle substantially conforms to the predetermined shape of the shaper;

determining a demarkation line between non-viable tissue and viable tissue;

excluding at least some of the non-viable tissue;

placing at least one suture along at least a portion of the demarkation line; and

pulling the suture such that the left ventricle is pulled around the shaper.

57. The method of claim 56, wherein at least a portion of the left ventricle substantially corresponds to the predetermined shape of the shaper.

58. The method of claim 56, wherein the determining of the demarkation line further comprises engaging a wall of the left ventricle of a beating heart to sense tactile feedback.

59. The method of claim 56, wherein the determining of the demarkation line further comprises visually determining akinetic and viable tissue.

60. The method of claim 56, wherein the determining of the demarkation line further comprises detecting electrical pulses from viable tissue.

61. The method of claim 56, further comprising suturing a patch along at least a portion of one of the demarkation lines.

62. A method for reshaping a left ventricle of a human heart, comprising:

positioning a shaper in the left ventricle, wherein the left ventricle has a first shape;

using the shaper as a model to reshape at least a portion of the left ventricle such that the reshaped left ventricle has a second shape;

removing the shaper from the left ventricle; and

attaching a patch to an interior of the left ventricle.

63. The method of claim 62, wherein the second shape is substantially similar to the shape of an appropriate left ventricle of a heart.

64. The method of claim 62, wherein the first shape is the shape of an enlarged left ventricle of a heart.

65. The method of claim 62, wherein the first shape is substantially spherical.

66. The method of claim 62, wherein the first shape comprises a greater volume relative to the second shape.

67. The method of claim 62, wherein at least a portion of the second shape substantially corresponds to at least a portion of a size of the shaper.

68. The method of claim 62, wherein at least a portion of the second shape substantially corresponds to at least a portion of a shape of the shaper.

69. The method of claim 62, wherein at least a portion of the second shape substantially corresponds to at least a portion of a size of the shaper, and wherein at least a portion of the second shape substantially corresponds to at least a portion of a shape of the shaper.

70. The method of claim 62, wherein the shaper has a short axis and a long axis.

71. The method of claim 62, wherein the shaper has a short axis and a long axis, and wherein the ratio of the short axis to the long axis is about 0.3 to about 0.7.

72. The method of claim 62, wherein the shaper is substantially ellipsoid in shape.

73. The method of claim 62, wherein the shaper is substantially conical in shape.

74. The method of claim 62, wherein the shaper is substantially pear shaped.

75. The method of claim 62, wherein the shaper is substantially tear drop shaped.

76. The method of claim 62, wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper.

77. The method of claim 62, wherein the reshaping comprises using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper.

78. The method of claim 62, further comprising determining a demarkation line between non-viable tissue and viable tissue of the left ventricle.

79. The method of claim 62, further comprising demarking between non-viable tissue and viable tissue of the left ventricle.

80. The method of claim 62, wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper and using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper.

81. The method of claim 62, further comprising demarking between non-viable tissue and viable tissue of the left ventricle, and wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper and using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper.

82. The method of claim 62, wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper and using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper, and further comprising attaching a patch to at least a portion of the left ventricle.

83. The method of claim 62, further comprising:

engaging a wall of the left ventricle of a beating heart to sense tactile feedback; and

determining a demarkation line between non-viable tissue and viable tissue of the left ventricle.

84. The method of claim 62, further comprising:

visually determining akinetic and viable tissue; and

determining a demarkation line between non-viable tissue and viable tissue of the left ventricle.

85. The method of claim 62, further comprising:

detecting electrical pulses from viable tissue; and

determining a demarkation line between non-viable tissue and viable tissue of the left ventricle.

86. The method of claim 62, further comprising excluding at least some of the non-viable tissue of the left ventricle.

87. The method of claim 62, further comprising:

determining a demarkation line between non-viable tissue and viable tissue of the left ventricle; and

excluding at least some of the non-viable tissue;

placing at least one suture along at least a portion of the demarkation line; and

pulling the suture such that the left ventricle is pulled around the shaper.

88. The method of claim 87, further comprising attaching a patch along at least a portion of one of the demarkation lines.

89. The method of claim 87, further comprising suturing a patch along at least a portion of one of the demarkation lines.

90. The method of claim 87, further comprising suturing a patch to an interior of the left ventricle.

91. The method of claim 87, further comprising excluding scar tissue from viable tissue of the left ventricle.

92. A shaping system, comprising:

a shaper positionable in a left ventricle of a human heart during use, wherein the shaper comprises a predetermined shape, wherein the predetermined shape acts as a pattern to reconstruct the left ventricle about the shaper during use, and wherein a first portion of the shaper has a first wall thickness;

wherein a second portion of the shaper comprises a second wall thickness greater than the first wall thickness, wherein the shaper is configured to inhibit perforation of the shaper during use, and wherein the second portion comprises a self sealing material.

93. The system of claim 92, wherein the shaper comprises an expandable balloon.

94. The system of claim 92, wherein the shaper comprises a predetermined contour.

95. The system of claim 92, wherein the shaper is configured to contain at least one fluid in at least a portion of the shaper.

96. The system of claim 92, wherein the shaper is configured to contain at least one shaper to the predetermined shape.

97. The system of claim 92, wherein the shaper is configured to inhibit expansion beyond a predetermined point.

98. The system of claim 92, wherein the shaper is configured to inhibit distortion of the predetermined shape when expanded.

99. The system of claim 92, wherein the shaper is expanded to the predetermined shape.

100. The system of claim 92, further comprising a tube coupled to the shaper, wherein the tube is configurable to convey a fluid to the shaper.

101. The system of claim 92, further comprising a tube coupled to the shaper, wherein the tube is configurable to convey a fluid to the shaper from a pressurized fluid reservoir.

102. The system of claim 92, further comprising a tube coupled to the shaper, wherein the tube is configurable to convey a fluid to the shaper from a pressurized fluid reservoir, and further comprising a valve coupled to the tube, wherein the valve is configurable to maintain a pressure of the fluid.

103. The system of claim 92, wherein the shaper has a short axis and a long axis.

104. The system of claim 92, wherein the shaper has a short axis and a long axis, and wherein the ratio of the short axis to the long axis is about 0.3 to about 0.7.

105. A shaping system, comprising:

a shaper positionable in a left ventricle of a human heart during use, wherein the shaper comprises a predetermined shape, wherein the predetermined shape acts as a pattern to reconstruct the left ventricle about the shaper during use, and wherein a first portion of the shaper has a first wall thickness;

wherein a second portion of the shaper comprises a second wall thickness greater than the first wall thickness, wherein the shaper is configured to inhibit perforation of the shaper during use, wherein the second portion comprises a self sealing material, and wherein the self sealing material comprises self sealing latex rubber.

106. The system of claim 105, wherein the shaper comprises an expandable balloon.

107. The system of claim 105, wherein the shaper comprises a predetermined contour.

108. The system of claim 105, wherein the shaper is configured to contain at least one fluid in at least a portion of the shaper.

109. The system of claim 105, wherein the shaper is configured to contain at least one fluid in at least a portion of the shaper, and wherein the fluid is configurable to expand the shaper to the predetermined shape.

110. The system of claim 105, wherein the shaper is configured to inhibit expansion beyond a predetermined point.

111. The system of claim 105, wherein the shaper is configured to inhibit distortion of the predetermined shape when expanded.

112. The system of claim 105, wherein the shaper is expanded to the predetermined shape.

113. The system of claim 105, further comprising a tube coupled to the shaper, wherein the tube is configurable to convey a fluid to the shaper.

114. The system of claim 105, further comprising a tube coupled to the shaper, wherein the tube is configurable to convey a fluid to the shaper from a pressurized fluid reservoir.

115. The system of claim 105, further comprising a tube coupled to the shaper, wherein the tube is configurable to convey a fluid to the shaper from a pressurized fluid reservoir, and further comprising a valve coupled to the tube, wherein the valve is configurable to maintain a pressure of the fluid.

116. The system of claim 105, wherein the shaper has a short axis and a long axis.

117. The system of claim 105, wherein the shaper has a short axis and a long axis, and wherein the ratio of the short axis to the long axis is about 0.3 to about 0.7.

118. A method for reshaping a left ventricle of a human heart, comprising:

engaging a wall of the left ventricle of a beating heart to sense tactile feedback;

determining a demarcation line between non-viable tissue and viable tissue of the left ventricle;

positioning a shaper in the left ventricle, wherein the left ventricle has a first shape;

using the shaper as a model to reshape at least a portion of the left ventricle such that the reshaped left ventricle has a second shape; and

removing the shaper from the left ventricle.

119. The method of claim 118, wherein the second shape is substantially similar to the shape of an appropriate left ventricle of a heart.

120. The method of claim 118, wherein the first shape is the shape of an enlarged left ventricle of a heart.

121. The method of claim 118, wherein the first shape is substantially spherical.

122. The method of claim 118, wherein the first shape comprises a greater volume relative to the second shape.

123. The method of claim 118, wherein at least a portion of the second shape substantially corresponds to at least a portion of a size of the shaper.

124. The method of claim 118, wherein at least a portion of the second shape substantially corresponds to at least a portion of a shape of the shaper.

125. The method of claim 118, wherein at least a portion of the second shape substantially corresponds to at least a portion of a size of the shaper, and wherein at least a portion of the second shape substantially corresponds to at least a portion of a shape of the shaper.

126. The method of claim 118, wherein the shaper has a short axis and a long axis.

127. The method of claim 118, wherein the shaper has a short axis and a long axis, and wherein the ratio of the short axis to the long axis is about 0.3 to about 0.7.

128. The method of claim 118, wherein the shaper is substantially ellipsoid in shape.

129. The method of claim 118, wherein the shaper is substantially conical in shape.

130. The method of claim 118, wherein the shaper is substantially pear shaped.

131. The method of claim 118, wherein the shaper is substantially tear drop shaped.

132. The method of claim 118, wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper.

133. The method of claim 118, wherein the reshaping comprises using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper.

134. The method of claim 118, further comprising demarking between non-viable tissue and viable tissue of the left ventricle.

135. The method of claim 118, wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper and using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper.

136. The method of claim 118, further comprising demarking between non-viable tissue and viable tissue of the left ventricle, and wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper and using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper.

137. The method of claim 118, wherein the reshaping comprises pressing at least a portion of the left ventricle against the shaper and using the firmness of the shaper to resist deformation of the shaper when at least a portion of the left ventricle is pressed against the shaper, and further comprising attaching a patch to at least a portion of the left ventricle.

138. The method of claim 118, further comprising visually determining akinetic and viable tissue.

139. The method of claim 118, further comprising detecting electrical pulses from viable tissue.

140. The method of claim 118, further comprising excluding at least some of the non-viable tissue of the left ventricle.

141. The method of claim 118, further comprising:

excluding at least some of the non-viable tissue;

placing at least one suture along at least a portion of the demarcation line; and

pulling the suture such that the left ventricle is pulled around the shaper.

142. The method of claim 141, further comprising attaching a patch along at least a portion of one of the demarcation lines.

143. The method of claim 141, further comprising suturing a patch along at least a portion of one of the demarcation lines.

144. The method of claim 141, further comprising suturing a patch to an interior of the left ventricle.

145. The method of claim 141, further comprising excluding scar tissue from viable tissue of the left ventricle.