Method and apparatus for valve repair

• US 20030069593A1
• Filed: 08/30/2002
• Published: 04/10/2003
• Est. Priority Date: 08/31/2001
• Status: Active Grant

• Current Assignee: Mitral Interventions Incorporated
• Original Assignee: Mitral Interventions Incorporated
• Inventors: Tremulis, William S., Razavi, Mahmood K.
• Granted Patent: US 7,125,421 B2
• Time in Patent Office: Days
• US Class Current: 606/142
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A tissue connection device is provided for use on a patient at a treatment site. The device comprises an elongate member having a distal end and a proximal end. The elongate member has a first, substantially linear configuration during delivery through an elongate delivery device, wherein the first configuration is sufficient to allow said member to be delivered percutaneously into the patient to the treatment site. The elongate member has a second, substantially circular configuration when said member disengages from the delivery device, wherein the second configuration is sufficient to support tissue at the treatment site. The elongate member in the second configuration defines a single ring.

Claims

1. A tissue connecting device for use with an elongate delivery device on tissue at a target site, the device comprising:

an elongate member deliverable to the target site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while engaged with said delivery device and a second substantially circular configuration defining a first support ring and a second support ring when removed from the delivery device;

wherein the elongate member has a first support ring radial thickness different from a second support ring radial thickness, said first support ring configured to abut against one side of the target tissue and said second support ring configured to abut against an opposite side of the target tissue to thereby capture a portion of the target tissue therebetween.

2. The device of claim 1 wherein the elongate member is deliverable percutaneously.

3. The device of claim 1 wherein the elongate member is deliverable to engage a heart valve.

4. The device of claim 1 wherein the first support ring radial thickness greater than said second ring radial thickness.

5. The device of claim 1 wherein at least an outer portion of the first support ring comprises a material selected from one of the following:

a nickel titanium alloy, superelastic metallic alloys, superelastic plastic, PTFE, silicone, stainless steel, and ceramic.

7. The device of claim 1 wherein said elongate member comprises a material allowing for penetration by a suture needle to attach a suture therein.

8. The device of claim 1 wherein said elongate member has an outer layer comprising a material allowing for penetration by a suture needle to attach a suture therein.

9. The device of claim 1 further comprising a plurality of apertures on said first ring sufficient for attachment of sutures to the first ring.

10. The device of claim 1 wherein first support ring has a surface suitable for engagement by sutures.

11. The device of claim 1 wherein said elongate member comprises a material suitable for penetration by sutures.

12. The device of claim 1 wherein first support ring has a mesh cover.

13. The device of claim 1 wherein the first support ring has a Dacron®

covering.

14. The device of claim 1 further comprising a plurality of anchoring locations on said first support ring sufficient to allow for attachment of sutures to the first ring.

15. The device of claim 1 further comprising at least one suture coupled to the elongate member.

16. The device of claim 1 further comprising at least one detachable suture removably coupled to the elongate member.

17. The device of claim 1 wherein said elongate member includes at least one radiopaque marker.

18. The device of claim 1 wherein said distal end is spaced apart from said proximal end when said elongate member is in the first, substantially linear configuration.

19. The device of claim 1 wherein said first support ring and said second support ring define an overlapping coil configuration.

20. The device of claim 19 wherein said first support ring is configured to engage an inner circumferential surface of the second support ring.

21. The device of claim 1 wherein said first support ring is in a plane parallel to a second support ring plane.

22. The device of claim 1 wherein said first support ring has a cloverleaf configuration when the elongate member is in the second configuration.

23. The device of claim 1 wherein said elongate member is configured to connect the first ring to the second ring without penetrating said target tissue.

24. The device of claim 1 wherein said first support ring is coupled to said second ring via a wire extending radially towards the center of the two rings in a manner sufficient to pass through a non-tissue center of the targeted valve.

25. The device of claim 1 wherein said elongate member is configured to connect the first ring to the second ring without penetrating said target tissue.

26. The device of claim 1 wherein said delivery device comprises a straightening mandrel.

27. The device of claim 1 wherein said elongate member contains a lumen therein for engaging a straightening mandrel.

28. The device of claim 1 wherein said delivery device comprises a catheter.

6. The device of claim I wherein said elongate member comprises a shape-memory material.

29. A tissue connecting device for use with an elongate delivery device on tissue at a target site, the device comprising:

an elongate member deliverable to a target site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while in the catheter and a second substantially circular configuration defining a first support ring and a second support ring when removed from the catheter;

wherein the second support ring is shaped to clamp down on the inner circumferential surface of the first support ring, wherein clamping by the first ring and the second ring urges tissue radially inward to enable better tissue capture and to lessen dilation of opening in the tissue.

30. The device of claim 29 wherein said first support ring has a diameter larger than said second support ring diameter.

31. The device of claim 29 wherein the outer ring contacts the tissue first and the inner ring pulls tissue radially inward to reduce dilation.

32. A tissue connection device for use with an elongate delivery device on tissue at a treatment site in a patient, the device comprising:

an elongate member deliverable to a target tissue site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while engaged with the elongate delivery device and a second relaxed configuration defining a first support ring and a second support ring when removed from the elongate delivery device, said first support ring configured to abut against one side of the target tissue and said second support ring configured to abut against an opposite side of the target tissue to capture said target tissue therebetween;

said first support ring coupled to said second support ring via a portion of the elongate member extending from the first support ring, radially inward towards the center of the first support ring, extending upward, and the radially outward towards the second support ring so as to avoid penetration of valve tissue while the first support ring and second support ring engage target tissue therebetween.

33. The device of claim 32 wherein the elongate member is deliverable percutaneously.

34. The device of claim 32 wherein the elongate member is deliverable to engage a heart valve.

35. The device of claim 32 having a first support ring radial thickness greater than a second ring radial thickness.

36. The device of claim 32 wherein at least an outer portion of the first support ring comprises a material selected from one of the following:

a nickel titanium alloy, superelastic metallic alloys, superelastic plastic, PTFE, silicone, stainless steel, and ceramic.

37. The device of claim 32 wherein said elongate member comprises a shape-memory material.

38. The device of claim 32 wherein said elongate member comprises a material allowing for penetration by a suture needle to attach a suture therein.

39. The device of claim 32 wherein said elongate member has an outer lawyer comprising a material allowing for penetration by a suture needle to attach a suture therein.

40. The device of claim 32 further comprising at least one detachable suture removably coupled to the elongate member.

41. The device of claim 32 wherein said elongate member includes at least one radiopaque marker.

42. The device of claim 32 wherein said first support ring and said second support ring define an overlapping coil configuration.

43. The device of claim 42 wherein said first support ring is configured to engage an inner radial surface of the second support ring.

44. The device of claim 32 wherein said first support ring has a cloverleaf configuration when the elongate member is in the second configuration.

45. The device of claim 32 wherein said elongate member contains a lumen therein for engaging a straightening mandrel.

46. The device of claim 32 wherein said delivery device comprises a catheter.

47. A tissue connection device for use with an elongate delivery device and at least one suture on tissue at a treatment site in a patient, the device comprising:

an elongate member deliverable to a target tissue site via the elongate delivery device, said elongate member assuming a first substantially linear configuration while engaged with the elongate delivery device and a second relaxed configuration defining a first support ring and a second support ring when removed from the elongate delivery device;

said elongate member in said circular configuration shaped to have a distance between a first ring tissue engaging surface and a second ring tissue engaging surface;

at least one suture coupled to said elongate member for seating said member against the treatment site.

48. The device of claim 47 wherein said suture reduces said distance therebetween and increases clamp force on any tissue between said first ring tissue engaging surface and the second ring tissue engaging surface.

49. The device of claim 47 wherein the elongate member is deliverable percutaneously.

50. The device of claim 47 wherein the elongate member has a reduced stiffness wherein said first ring and said second ring reduce valve dilation of tissue therebetween only with use of said suture.

51. The device of claim 47 wherein the elongate member is deliverable percutaneously.

52. The device of claim 47 wherein the elongate member is deliverable to engage a heart valve.

53. The device of claim 47 wherein the first support ring radial thickness greater than said second ring radial thickness.

54. The device of claim 47 wherein at least an outer portion of the first support ring comprises a material selected from one of the following:

a nickel titanium alloy, superelastic metallic alloys, superelastic plastic, PTFE, silicone, stainless steel, and ceramic.

55. The device of claim 47 wherein said elongate member comprises a shape-memory material.

56. The device of claim 47 wherein said elongate member comprises a material allowing for penetration by a suture needle to attach a suture therein.

57. The device of claim 47 wherein said elongate member has an outer lawyer comprising a material allowing for penetration by a suture needle to attach a suture therein.

58. The device of claim 47 further comprising a plurality of apertures on said first ring sufficient for attachment of sutures to the first ring.

59. The device of claim 47 wherein first support ring has a surface suitable for engagement by sutures.

60. The device of claim 47 wherein said elongate member comprises a material suitable for penetration by sutures.

61. The device of claim 47 wherein first support ring has a mesh cover.

62. The device of claim 47 wherein the first support ring has a Dacron®

covering.

63. The device of claim 47 further comprising a plurality of anchoring locations on said first support ring sufficient to allow for attachment of sutures to the first ring.

64. The device of claim 47 further comprising at least one suture coupled to the elongate member.

65. The device of claim 47 further comprising at least one detachable suture removably coupled to the elongate member.

66. The device of claim 47 wherein said elongate member includes at least one radiopaque marker.

67. The device of claim 47 wherein said distal end is spaced apart from said proximal end when said elongate member is in the first, substantially linear configuration.

68. The device of claim 47 wherein said first support ring and said second support ring define an overlapping coil configuration.

69. The device of claim 68 wherein said first support ring is configured to engage an inner circumferential surface of the second support ring.

70. The device of claim 47 wherein said first support ring is in a plane parallel to a second support ring plane.

71. The device of claim 47 wherein said first support ring has a cloverleaf configuration when the elongate member is in the second configuration.

72. The device of claim 47 wherein said elongate member is configured to connect the first ring to the second ring without penetrating said target tissue.

73. The device of claim 47 wherein said first support ring is coupled to said second ring via a wire extending radially towards the center of the two rings in a manner sufficient to pass through a non-tissue center of the targeted valve.

74. The device of claim 47 wherein said elongate member is configured to connect the first ring to the second ring without penetrating said target tissue.

75. The device of claim 47 wherein said delivery device comprises a straightening mandrel.

76. The device of claim 47 wherein said elongate member contains a lumen therein for engaging a straightening mandrel.

77. The device of claim 47 wherein said delivery device comprises a catheter.

78. A tissue connection device for use with a tubular delivery device, said tissue connection device comprising:

a central body;

a first leaflet clamp coupled to said central body and extending radially outward from the central body and defining an upper compressive portion;

a second leaflet clamp coupled to said central body and extending radially outward from the central body and defining a lower compressive portion;

wherein first leaflet clamp and second leaflet clamp coupled to the central body are deliverable through said tubular delivery device, said first leaflet clamp and second leaflet clamp assuming a first folded configuration during delivery to a target site, said leaflets clamps deflected towards a longitudinal axis of the central body to provide a reduced diameter;

wherein first leaflet clamp and second leaflet clamp assume a second, opened configuration having an extended diameter after exiting the tubular delivery device, said first leaflet clamp configured to abut against one side of the target tissue and said second leaflet clamp configured to abut against an opposite side of the target tissue to thereby capture a portion of the target tissue therebetween.

79. The device of claim 78 wherein said first leaflet clamp comprises a wire loop, wherein said wire loop starts from the central body, extends radially outward, and then returns to the central body.

80. The device of claim 79 wherein at least a portion of the first leaflet clamp has a curved configuration.

81. The device of claim 78 wherein said first leaflet clamp has a geometry suitable for supporting at least one leaflet of the valve.

82. The device of claim 78 wherein said first leaflet clamp has a propeller configuration.

83. The device of claim 78 wherein said first leaflet clamp has a flattened oar configuration.

84. The device of claim 78 wherein said first leaflet clamp has a paddle configuration.

85. The device of claim 78 where said first leaflet clamp and said second leaflet clamp in said second, opened configuration provides compressive force between the first leaflet clamp and the second leaflet clamp.

86. The device of claim 78 where said first leaflet clamp comprises a plurality of wire loops extending radially outward from the center body.

87. The device of claim 78 where said second leaflet clamp comprise a plurality of wire loops extending radially outward from the center body.

88. The device of claim 78 wherein the first leaflet clamp and second leaflet clamp are deliverable percutaneously.

89. The device of claim 78 wherein the first leaflet clamp and second leaflet clamp are deliverable to engage a heart valve.

90. The device of claim 78 wherein said first leaflet clamp and second leaflet clamp comprises a material selected from one of the following:

a nickel titanium alloy, superelastic metallic alloys, superelastic plastic, PTFE, silicone, stainless steel, and ceramic.

91. The device of claim 78 wherein first leaflet clamp and second leaflet clamp comprises a shape-memory material.

92. The device of claim 78 wherein first leaflet clamp and second leaflet clamp comprises a superelastic material.

94. The device of claim 92 wherein said first clamp portion assumes a collapsed configuration during delivery through the tubular delivery device which temporarily deflects the first leaflet towards said central body to create a reduced diameter, said first leaflet assuming a second open configuration having a larger diameter when removed from the tubular delivery device.

95. The device of claim 92 wherein said spine includes a guidewire lumen for facilitating delivery of the second clamp portion to a treatment site.

96. The device of claim 92 wherein first leaflet comprises a wire extending radially outward from the central body and follows a circular path around the central body.

97. The device of claim 96 wherein first leaflet remains substantially in one plane.

98. The device of claim 92 wherein a portion of said spine has a barbed configuration.

99. The device of claim 98 further comprising a slot extending longitudinally along said portion of the spine with the barbed configuration, said slot configured to allow the spine to be radially compressed and assume a reduced diameter configuration.

100. The device of claim 98 further comprising a slot extending longitudinally along said portion of the spine with the barbed configuration, said slot configured to allow the spine to be radially compressed and release its locking engagement with the central body.

101. The device of claim 99 wherein a removable suture is coupled to one end of the spine capable of providing a compressive force to urge the spine to the reduced diameter configuration.

102. The device of claim 92 wherein the first clamp portion and second clamp portion are deliverable percutaneously.

103. The device of claim 92 wherein the first clamp portion and second clamp portion are deliverable to engage a heart valve.

104. The device of claim 92 wherein the first clamp portion and second clamp portion comprise a material selected from one of the following:

a nickel titanium alloy, superelastic metallic alloys, superelastic plastic, PTFE, silicone, stainless steel, and ceramic.

105. The device of claim 92 wherein the first clamp portion and second clamp portion comprise a shape-memory material.

93. A tissue connection device for use with a tubular delivery device, said tissue connection device comprising:

a first clamp portion having a central body with a lumen and at least a first leaflet extending radially away from said central body;

a second clamp portion having a spine and at least a second leaflet extending radially away from said spine;

wherein said spine of the second clamp portion is configured to slidably engage the lumen on said central body and the spine is shaped to retain said first clamp portion in a position where said first clamp portion abuts against one side of a target tissue and said second clamp portion abuts against an opposite side of the target tissue to thereby engage a portion of the tissue therebetween.

106. A tissue connection device for use on a patient at a treatment site, the device comprising:

an elongate member having a distal end and a proximal end,

said member having a first, substantially linear configuration during delivery through an elongate delivery device, said first configuration sufficient to allow said member to be delivered percutaneously into the patient to the treatment site, and

said member having a second, substantially circular configuration when said member disengages from said delivery device, said second configuration sufficient to support tissue at said treatment site, wherein said elongate member in said second configuration is delivered entirely on one side of the treatment site.

107. The device of claim 106 wherein said elongate member defines a single ring.

108. The device of claim 106 wherein said elongate member has a rounded distal end.

109. The device of claim 106 wherein said single ring has a non-overlapping configuration.

110. The device of claim 106 wherein said distal end of the elongate member is spaced apart from said proximal end when said member is in the first, substantially linear configuration.

111. The device of claim 106 wherein single ring has a cloverleaf geometry when said elongate member is in the relaxed configuration.

112. The device of claim 106 wherein the elongate member is deliverable percutaneously.

113. The device of claim 106 wherein the elongate member is deliverable to engage a heart valve.

114. The device of claim 106 having a first support ring radial thickness greater than a second ring radial thickness.

115. The device of claim 106 wherein at least an outer portion of the first support ring comprises a material selected from one of the following:

a nickel titanium alloy, superelastic metallic alloys, superelastic plastic, PTFE, silicone, stainless steel, and ceramic.

116. The device of claim 106 wherein said elongate member comprises a shape-memory material.

117. The device of claim 106 wherein said elongate member comprises a shapememory material.

118. The device of claim 106 wherein said elongate member comprises a superelastic material.

119. The device of claim 106 wherein said elongate member comprises a material allowing for penetration by a suture needle to attach a suture therein.

120. The device of claim 106 wherein said elongate member has an outer lawyer comprising a material allowing for penetration by a suture needle to attach a suture therein.

121. The device of claim 106 further comprising at least one detachable suture removably coupled to the elongate member.

122. The device of claim 106 wherein said elongate member includes at least one radiopaque marker.

123. The device of claim 106 wherein said first support ring and said second support ring define an overlapping coil configuration.

124. The device of claim 106 wherein said first support ring has a cloverleaf configuration when the elongate member is in the second configuration.

125. The device of claim 106 wherein said elongate member contains a lumen therein for engaging a straightening mandrel.

126. The device of claim 106 wherein said delivery device comprises a catheter.

127. A method for valve repair on a patient at a treatment site, said method comprising:

using an elongate delivery device to percutaneously deliver a tissue connection device to the treatment site;

said tissue connection device having a first, substantially linear configuration when engaged with the delivery device and a second, substantially circular configuration when said device disengages with said delivery device;

delivering said tissue connection device entirely on one side of said treatment site.

128. The method of claim 127 wherein said treatment site comprises a heart valve.

129. The method of claim 127 wherein said treatment site comprises a valve leaflet.

130. The method of claim 127 wherein said delivering comprises directing said delivery device through a vein into the venus side of the heart, into a right atrium, and through an atrial wall into the a left atrium of the patient.

131. The method of claim 127 wherein said delivering comprises directing the delivery device through an artery, into the arterial side of the heart, and through an aortic valve of the patient.

132. The method of claim 127 further comprising using an anchor to secure the suture to the treatment tissue.

133. The method of claim 127 wherein said elongate delivery device comprises a straightening mandrel.

134. The method of claim 127 wherein elongate delivery device comprises a guide catheter.

135. The method of claim 127 wherein said tissue connection device engages said tissue for anchoring, without fully penetrating the tissue to reach an opposite side of the tissue.

136. A method for valve repair on a patient at a treatment site, said method comprising:

directing sutures through said target tissue to provide anchoring sites at said treatment site;

connecting said sutures to a tissue connection device, wherein said tissue connection device is slidable over said sutures;

using an elongate delivery device to percutaneously deliver the tissue connection device to a target tissue site;

said tissue connection device having a first, substantially linear configuration when engaged with the delivery device and a second, substantially circular configuration when said tissue connection device disengages with said delivery device;

delivering said tissue connection device entirely on one side of said treatment site.

137. The method of claim 136 further comprising advancing at least one knot to secure the ring to the tissue, said knot advanced by a knot pusher.

138. The method of claim 136 further comprising securing the ring to the tissue using a clamp device.

139. The method of claim 136 wherein said sutures connecting of sutures to said tissue connection device occurs outside the patient'"'"'s body.

140. The method of claim 136 wherein said sutures extend from said treatment site to outside the patient'"'"'s body prior to connection to said tissue treatment device.

141. The method of claim 136 wherein elongate delivery device comprises a straightening mandrel and said tissue connection device includes a lumen for slidably receiving said mandrel.

142. The method of claim 136 wherein elongate delivery device comprises a guide catheter.

143. The method of claim 136 wherein said delivering comprises directing said delivery device through a vein into the venus side of the heart, into a right atrium, and through an atrial wall into the a left atrium of the patient.

144. The method of claim 136 wherein said delivering comprises directing the delivery device through an artery, into the arterial side of the heart, and through an aortic valve of the patient.

145. The method of claim 136 further comprising using an anchor to secure the suture to the treatment tissue.

146. A method for repairing a tissue valve having an annulus and a plurality of valve leaflets, said method comprising:

positioning an elongate delivery device between said valve leaflets without penetrating valve tissue to provide access to first side of the valve to percutaneously deliver a first portion of the tissue connection device to a target tissue site;

withdrawing said delivery device from between the leaflets to the opposite side of the tissue to continue delivery of the remaining portion of the tissue connection device on said opposite side thereby engaging said leaflets therebetween;

said tissue connection device having a first, substantially linear configuration when engaged with said delivery device and a second, substantially circular configuration when said member disengages with said delivery device.

147. The method of claim 146 wherein said positioning comprises delivering said delivery device through a vein into the venus side of the heart, into a right atrium, and through an atrial wall into the a left atrium of the patient.

148. The method of claim 146 wherein said positioning of the delivery device comprises delivering said delivery device through an artery, into the arterial side of the heart, and through an aortic valve of the patient.

149. The method of claim 146 wherein first portion comprise a first support ring.

150. The method of claim 146 wherein first portion comprise a first wire loop.

151. The method of claim 146 wherein first portion comprise a first leaflet clamp coupled to a central body.

152. A method for repairing a tissue valve having an annulus and a plurality of valve leaflets, said method comprising:

positioning an elongate delivery device to provide access to first side of the valve to percutaneously deliver a first portion of the tissue connection device to a target tissue site;

withdrawing said delivery device from between the leaflets to the opposite side of the tissue to continue delivery of the remaining portion of the tissue connection device on said opposite side wherein said first portion and said portion on the opposite side are substantially spaced apart by a distance, said tissue connection device having a first, substantially linear configuration when engaged with said delivery device and a second, substantially circular configuration when said member disengages with said delivery device;

using at least one suture to draw the first portion and the second remaining together to compress tissue therebetween to reshape said valve leaflets.

153. A method for repairing a tissue valve having an annulus and a plurality of valve leaflets, said method comprising:

positioning a first tubular delivery device on one side of the tissue valve to deliver a first support member to a target tissue site;

positioning a second tubular delivery device on an opposite side of the tissue valve to deliver a second support member to a target tissue site;

extending a guide wire outward from the first tubular delivery device, past the tissue valve, and into the second tubular delivery device to provide for alignment between said first tubular delivery device and second tubular delivery device.

154. The method of claim 153 wherein said first tubular delivery device is positioned to percutaneously deliver a first portion of the tissue connection device.

155. The method of claim 153 further comprising using said guide wire to align the first support member with the second support member to capture tissue therebetween.

156. The method of claim 153 wherein said first tubular delivery device comprises a guide catheter.

157. The method of claim 153 wherein the extending step further comprises capturing the guide wire to draw the guide wire into the second tubular delivery device.

158. The method of claim 153 wherein said positioning of the first tubular delivery device comprises delivering said first tubular delivery device through a vein into the venus side of the heart, into a right atrium, and through an atrial wall into the a left atrium of the patient.

159. The method of claim 153 wherein said positioning of the second tubular delivery device comprises delivering said second tubular delivery device through an artery, into the arterial side of the heart, and through an aortic valve of the patient.

160. The method of claim 153 wherein said first tubular device is placed in a trans-septal position in the patient'"'"'s heart.

161. The method of claim 153 wherein said guide wire has at least a length sufficient to extend through the first tubular delivery device and the second tubular delivery device.

162. A kit for delivering a tissue connection device to a valve having an annulus and a plurality of leaflets, the device using an elongate delivery device, the kit comprising:

an elongate member having a first substantially linear configuration when engaged with the elongate delivery device and a second substantially circular configuration defining a first support ring and a second support ring when said member disengages from the delivery device, said elongate member deliverable minimally invasively to said treatment site;

instructions for use describing a method for connecting the elongate member to the valve;

a package for holding the elongate member and the instructions for use.

163. The method of claim 162 wherein the elongate member has a first support ring radial thickness different from a second support ring radial thickness, said first support ring configured to abut against one side of the target tissue and said second support ring configured to abut against an opposite side of the target tissue to thereby engage a portion of the tissue therebetween.