Ventricular restoration shaping apparatus and method of use
View Patent ↗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.
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.