Methods and devices for improving mitral valve function

• US 20050075723A1
• Filed: 05/07/2004
• Published: 04/07/2005
• Est. Priority Date: 10/06/2000
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Schroeder, Richard, Kalgreen, Jason, Mortier, Todd, Keith, Peter, Vidlund, Robert, Schweich, Cyril Jr., Simmon, Marc
• Application Number:
  US10/840,511
• Publication Number:
  US 20050075723A1
• Time in Patent Office: Days
• US Class Current: 623/2.100
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

The various aspects of the invention pertain to devices and related methods for treating heart conditions, including, for example, dilatation, valve incompetencies, including mitral valve leakage, and other similar heart failure conditions. The devices and related methods of the present invention operate to assist in the apposition of heart valve leaflets to improve valve function. According to one aspect of the invention, a method improves the function of a valve of a heart by placing an elongate member transverse a heart chamber so that each end of the elongate member extends through a wall of the heart, and placing first and second anchoring members external the chamber. The first and second anchoring members are attached to first and second ends of the elongate member to fix the elongate member in a position across the chamber so as to reposition papillary muscles within the chamber. Also described herein is a method for placing a splint assembly transverse a heart chamber by advancing an elongate member through vasculature structure and into the heart chamber.

Claims

1-119. -119. (canceled)

120. A method for improving the function of a valve of a heart, the method comprising:

endovascularly delivering an elongate member and first and second anchoring members to the heart;

placing the elongate member transverse a heart chamber so that each end of the elongate member extends through a wall of the heart; and

placing the first and second anchoring members external the chamber, the first and second anchoring members being attached to the ends of the elongate member to fix the elongate member in a position across the chamber, wherein the position is superior to the papillary muscles and proximate and substantially across the valve.

121. The method of claim 120, wherein the heart chamber is the left ventricle and the valve is the mitral valve.

122. The method of claim 121, further comprising advancing the elongate member and first and second anchoring members into the right ventricle and then to the left ventricle.

123. The method of claim 122, further comprising advancing the elongate member from the right ventricle through the septal wall of the heart and to the left ventricle.

124. The method of claim 120, further comprising advancing the elongate member and first and second anchoring members into the heart chamber without entering another heart chamber first.

125. The method of claim 120, wherein the position of the elongate member alters a shape of an annulus of the valve.

126. The method of claim 120, wherein the position of the elongate member repositions the papillary muscles within the chamber.

127. The method of claim 120, wherein endovascularly delivering the elongate member and first and second anchoring members to the heart includes delivering the elongate member and first and second anchoring members into a heart chamber from a vein.

128. The method of claim 120, wherein the elongate member is advanced through a guide device endovascularly inserted into the right ventricle.

129. The method of claim 128, wherein the guide device is a catheter.

130. The method of claim 128, wherein inserting the guide device includes extending the guide device across the left ventricle from the right ventricle through a first location on a free wall surrounding the left ventricle and through a second location on a septal wall.

131. The method of claim 128, wherein inserting the guide device includes stabilizing the guide device with respect to the left ventricle.

132. The method of claim 131, wherein the stabilizing includes inflating balloons disposed proximate a distal end of the guide device.

133. The method of claim 132, wherein the stabilizing includes inflating a first balloon adjacent a first exterior surface of the heart chamber wall and a second balloon adjacent an interior surface of the heart chamber wall.

134. The method of claim 121, wherein the elongate member is advanced through a guide device endovascularly inserted into the left ventricle without first entering another heart chamber.

135. The method of claim 134, wherein the guide device includes a first guide member and a second guide member, said first guide member being configured to extend toward a first interior surface of the chamber wall at a first location and said second guide member being configured to extend toward a second interior surface of the chamber wall at a second location.

136. The method of claim 135, wherein the inserting includes stabilizing said first guide member at the first interior surface and the second guide member at the second interior surface.

137. The method of claim 136, wherein the stabilizing includes inflating balloons disposed proximate the distal end of each of the first and second guide members.

138. The method of claim 137, wherein the stabilizing includes inflating a first balloon on each of the first and second guide members adjacent first and second exterior surfaces of the chamber wall respectively and a second balloon on each of the guide members adjacent the first and second interior surfaces of the chamber wall.

139. The method of claim 135, wherein the first and second guide members are adjustably curvable catheters.

140. The method of claim 120, wherein the first anchoring member is expandable and the method further comprises expanding at least a portion of the first anchoring member.

141. The method of claim 140, wherein the expanding includes applying an outwardly directed force from within the portion of the first anchoring member.

142. The method of claim 141, wherein the applying includes inflating the portion of the first anchoring member.

143. The method of claim 140, wherein the portion of the first anchoring member is made of a shape memory alloy and is self-expandable.

144. The method of claim 120, wherein at least a portion of the first anchoring member is integrally formed with the elongate member.

145. The method of claim 120, wherein the placing the second anchoring member includes adjusting a length of the elongate member between the first and second anchoring members.

146. The method of claim 145, wherein the adjusting the length includes changing the cross-sectional shape of the heart chamber.

147. The method of claim 145, wherein the adjusting the length includes changing the radius of curvature of the heart chamber.

148. The method of claim 145, wherein the adjusting the length includes changing a shape of the valve annulus.

149. The method of claim 120, further comprising inserting a guide device through vasculature structure and into the heart, wherein the delivering includes advancing the elongate member and first and second anchors through the guide device.

150. The method of claim 149, wherein inserting the guide device includes inserting the guide device through a chamber wall at first and second locations.

151. The method of claim 150, wherein the inserting through the chamber wall includes advancing the guide device over a needle extending through the chamber wall at the first and second locations.

152. The method of claim 151, wherein the needle extends from a distal end of the guide device to extend through the chamber wall.

188. The method of claim 120, further comprising real-time monitoring valve function.

189. The method of claim 188, wherein the real-time monitoring includes ultrasound imaging the valve.

153. A splint for improving the function of a valve of a heart, the splint comprising:

an elongate member configured to be positioned transverse a heart chamber so that each end of the elongate member extends through a wall of the heart; and

first and second anchoring members configured to be positioned external the chamber and attached to the ends of the elongate member to fix the elongate member in a position across the chamber,

wherein the first anchoring member includes a first portion configured to contact a first region of the heart proximate the valve to change a shape of the valve, and

wherein the elongate member and the first and second anchoring members are configured to be endovascularly delivered to the heart.

154. The splint of claim 153, wherein the heart chamber is the left ventricle and the valve is the mitral valve.

155. The splint of claim 154, wherein the first region of the heart is a superior portion of the left ventricle proximate an annulus of the mitral valve.

156. The splint of claim 154, wherein the first region of the heart is a portion of the left atrium proximate an annulus of the mitral valve.

157. The splint of claim 153, wherein the first portion has an oblong shape.

158. The splint of claim 153, wherein the first anchoring member further includes a second portion configured to contact a second region of the heart below the first region.

159. The splint of claim 158, wherein the second portion includes a first structure connected to the elongate member and a second structure connected to the first portion by the first structure.

160. The splint of claim 153, wherein the elongate member and first and second anchoring members are configured to be delivered via a guide device through vasculature.

161. The splint of claim 154, wherein the elongate member and first and second anchoring members are configured to be delivered into the right ventricle prior to placement of the elongate member transverse the left ventricle.

162. The splint of claim 154, wherein the elongate member and first and second anchoring members are configured to be delivered into the left ventricle without first entering another heart chamber.

163. The splint of claim 153, wherein the second anchoring member is configured to contact a septal wall.

164. A method for improving the function of a valve of a heart, the method comprising:

endovascularly delivering an elongate member and first and second anchoring members to the heart;

placing the elongate member transverse a heart chamber so that each end of the elongate member extends through a wall of the heart; and

placing the first and second anchoring members external the chamber, the first and second anchoring members being attached to first and second ends of the elongate member to fix the elongate member in a position across the chamber so as to reposition papillary muscles within the chamber.

165. The method of claim 164, wherein the first end of the elongate member extends through a wall of the left ventricle between papillary muscles.

166. The method of claim 165, wherein the second end of the elongate member extends through a septum of the heart.

167. The method of claim 164, wherein the chamber is the left ventricle and the valve is the mitral valve.

168. The method of claim 167, further comprising advancing the elongate member and first and second anchoring members into the right ventricle and then to the left ventricle.

169. The method of claim 168, further comprising advancing the elongate member from the right ventricle through the septal wall of the heart and to the left ventricle.

170. The method of claim 164, further comprising advancing the elongate member and first and second anchoring members into the heart chamber without entering another heart chamber first.

171. The method of claim 164, wherein the position is superior to the papillary muscles and proximate and substantially across the valve.

172. The method of claim 164, wherein the elongate member is fixed in the position so as to alter the shape of an annulus of the valve.

173. A method for improving the function of a valve of a heart, comprising:

placing a multifilament elongate member relative to the heart so that the elongate member contacts cardiac structure other than structure of the valve and alters a shape of the valve;

adjusting the elongate member relative to the heart; and

securing the elongate member relative to the heart, wherein the securing includes placing a pin through the elongate member.

174. The method of claim 173, wherein adjusting the elongate member relative to the heart includes adjusting a position of the elongate member relative to an anchor.

175. The method of claim 174, wherein securing the elongate member relative to the heart includes securing the elongate member to the anchor.

176. The method of claim 173, wherein the elongate member is comprised of a polymer.

177. The method of claim 173, wherein placing the elongate member relative to the heart includes placing the elongate member external to the heart chambers.

178. The method of claim 173, wherein the elongate member includes a covering.

179. The method of claim 173, wherein the elongate member is flexible.

180. The method of claim 173, further comprising endovascularly delivering the elongate member to the heart.

181. The method of claim 180, wherein endovascularly delivering the device to the heart includes delivering the device through venous vasculature.

182. The method of claim 180, wherein endovascularly delivering the device to the heart includes delivering the device through arterial vasculature.

183. The method of claim 180, wherein endovascularly delivering the device to the heart includes delivering the device through a catheter having an adjustable tip portion.

184. The method of claim 173, further comprising real-time monitoring valve function.

185. The method of claim 184, wherein the real-time monitoring includes ultrasound imaging the valve.

186. The method of claim 184, wherein adjusting the elongate member relative to the heart is based on data obtained during the adjusting from the real-time monitoring of valve function.

187. The method of claim 173, wherein the multifilament elongate member is braided.