Closure devices, related delivery methods and tools, and related methods of use

• US 20060036282A1
• Filed: 08/08/2005
• Published: 02/16/2006
• Est. Priority Date: 06/01/2001
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Velocimed PFO, Inc.
• Inventors: Ressemann, Thomas V., Blaeser, David J., Keith, Peter T., Wahr, Dennis W.
• Granted Patent: US 7,717,937 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00351 Heart

Abstract

A device for sealing a patent foramen ovale (PFO) in the heart is provided. The device includes a left atrial anchor adapted to be placed in a left atrium of the heart, a right atrial anchor adapted to be placed in a right atrium of the heart, and an elongate member adapted to extend through the passageway and connect the left and right atrial anchors. The right atrial anchor preferably includes a plurality of arms and a cover attached to the arms. The left atrial anchor also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end of fixedly connected to the left atrial anchor and a portion, proximal to the first end, releasably connected to the right atrial anchor. Preferably, the elongate member is flexible.

Claims

1-102. -102. (canceled)

103. A device for sealing a passageway in a human heart, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of arms radiating from a first central hub;

a second anchor adapted to be placed proximate a second end of the passageway, the second anchor including a plurality of arms radiating from a second central hub;

an elongate member adapted to extend through the passageway and connect the first and second anchors, the elongate member being configured to permanently connect the first and second anchors implanted in the body; and

a securing element positioned on and movable relative to the elongate member to permanently secure the location of the second anchor on the elongate member.

104. The device of claim 103, wherein the passageway is a patent foramen ovale.

105. The device of claim 103, wherein the elongate member is flexible.

106. The device of claim 103, wherein the plurality of arms of the first anchor can assume a collapsed state and a deployed state.

107. The device of claim 103, wherein the plurality of arms of the second anchor can assume a collapsed state and a deployed state.

108. The device of claim 103, wherein the first anchor pivots relative to the elongate member.

109. The device of claim 103, wherein the second anchor pivots relative to the elongate member.

110. The device of claim 103, wherein the elongate member is capable of moving through the second anchor to vary a length of the elongate member between the first and second anchors.

111. The device of claim 103, wherein the second anchor is movable with respect to the elongate member.

112. The device of claim 103, wherein the elongate member includes an operative portion configured to receive the securing element to secure the position of the second anchor relative to the elongate member, and wherein the securing element may be positioned at any point along a length of the operative portion of the elongate member.

113. The device of claim 103, wherein the elongate member is configured to move through the second anchor to vary a tension of the elongate member.

114. The device of claim 103, wherein the securing element is movable in only one direction along the elongate member.

115. The device of claim 103, wherein the second anchor includes a cover spanning between its plurality of arms.

116. The device of claim 115, wherein the first anchor does not include structure spanning between its plurality of arms.

117. The device of claim 103, wherein the elongate member has sufficient flexibility to conform to a shape of the passageway.

118. The device of claim 103, wherein the plurality of arms of the first anchor are made of a first material and the elongate member is made of a second material different from the first material.

119. The device of claim 118, wherein the plurality of arms of the second anchor are made from the first material.

120. The device of claim 103, wherein the elongate member is a braided structure.

121. The device of claim 103, wherein the elongate member is a multifilar structure.

122. A device for sealing a passageway in a human heart, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of arms radiating from a first central hub;

a second anchor adapted to be placed proximate a second end of the passageway, the second anchor including a plurality of arms radiating from a second central hub;

an elongate member adapted to extend through the passageway and connect the first and second anchors, the elongate member including a portion having a substantially uniform diameter; and

a securing element movable on the elongate member to permanently secure the location of the second anchor on the portion of the elongate member having a substantially uniform diameter.

123. The device of claim 122, wherein the passageway is a patent foramen ovale.

124. The device of claim 122, wherein the elongate member is flexible.

125. The device of claim 122, wherein the plurality of arms of the first anchor can assume a collapsed state and a deployed state.

126. The device of claim 122, wherein the plurality of arms of the second anchor can assume a collapsed state and a deployed state.

127. The device of claim 122, wherein the elongate member is capable of moving through the second anchor to vary a length of the elongate member between the first and second anchors.

128. The device of claim 122, wherein the securing element may be positioned at any point along the portion of the elongate member having a substantially uniform diameter.

129. The device of claim 122, wherein the elongate member is configured to move through the second anchor to vary a tension of the elongate member.

130. The device of claim 122, wherein the securing element is movable in only one direction along the elongate member.

131. The device of claim 122, wherein the second anchor includes a cover spanning between its plurality of arms.

132. The device of claim 131, wherein the first anchor does not include structure spanning between its plurality of arms.

133. The device of claim 122, wherein the elongate member has sufficient flexibility to conform to a shape of the passageway.

134. The device of claim 122, wherein the plurality of arms of the first anchor are made of a first material and the elongate member is made of a second material different from the first material.

135. The device of claim 134, wherein the plurality of arms of the second anchor are made from the first material.

136. The device of claim 122, wherein the elongate member is a braided structure.

137. The device of claim 122, wherein the elongate member is a multifilar structure.

138. A device for sealing a passageway in a human heart, the device comprising:

a first anchor adapted to be placed proximate a first end of the passageway, the first anchor including a plurality of arms radiating from a first central hub;

a second anchor adapted to be placed proximate a second end of the passageway, the second anchor including a plurality of arms radiating from a second central hub; and

an elongate member connected to the first central hub of the first anchor, the elongate member being free to move longitudinally through the second central hub of the second anchor,

wherein the device is movable between a collapsed configuration and a deployed configuration, the device being configured to fit within a delivery sheath in the collapsed configuration such that, when in the collapsed configuration, the first central hub of the first anchor abuts the second central hub of the second anchor.

139. A method for closing a patent foramen ovale (PFO) between two atria in a heart of a patient, comprising:

introducing a closure device to the heart in an undeployed configuration, said closure device comprising a self expanding left atrial anchor, a self-expanding right atrial anchor, a flexible elongate member permanently secured to the left atrial anchor and extending to and through the right atrial anchor, and a securing element;

positioning the left atrial anchor in the left atrium of the heart;

deploying the left atrial anchor;

positioning the right atrial anchor in the right atrium of the heart;

deploying the right atrial anchor;

moving the right atrial anchor along the elongate member to a desired position on the elongate member; and

actuating the securing element to permanently secure the position of the right atrial anchor relative to the elongate member.

140. The method of claim 139, wherein introducing a closure device to the heart in an undeployed configuration includes advancing a sheath containing the closure device in the undeployed configuration into the heart.

141. The method of claim 140, wherein positioning the left atrial anchor in the left atrium of the heart includes advancing the sheath containing the device through the PFO and into the left atrium of the heart.

142. The method of claim 139, wherein deploying the left atrial anchor includes expanding the left atrial anchor from the undeployed configuration to the deployed configuration.

143. The method of claim 142, further comprising placing the left atrial anchor adjacent to a left atrial side of the PFO subsequent to deploying the left atrial anchor.

144. The method of claim 143, wherein placing the left atrial anchor further includes pulling the flexible elongate member in a proximal direction to seat the left atrial anchor against the septum primum.

145. The method of claim 144, wherein placing the left atrial anchor further includes pulling the flexible elongate member in a proximal direction to seat the left atrial anchor against the septum primum and the septum secundum.

146. The method of claim 141, wherein positioning the right atrial anchor in the right atrium of the heart includes withdrawing the sheath through the PFO and into the right atrium of the heart.

147. The method of claim 139, wherein deploying the right atrial anchor includes expanding the right atrial anchor from the undeployed configuration to the deployed configuration.

148. The method of claim 147, wherein deploying the right atrial anchor in the right atrium includes deploying the right atrial anchor a substantial distance away from the septum secundum, such that the right atrial anchor does not contact the septum secundum as it expands.

149. The method of claim 139, wherein moving the right atrial anchor along the flexible elongate member includes advancing the right atrial anchor in a distal direction along the flexible elongate member.

150. The method of claim 149, further comprising placing the right atrial anchor adjacent to a right atrial side of the PFO subsequent to advancing the right atrial anchor along the flexible elongate member.

151. The method of claim 139, wherein actuating the securing element to permanently secure the position of the right atrial anchor includes advancing the securing element out of the sheath subsequent to placing the right atrial anchor adjacent to the right atrial side of the PFO.

152. The method of claim 151, wherein actuating the securing element to permanently secure the position of the right atrial anchor further includes moving the securing element along the elongate member to a position proximal to the right atrial anchor.

153. The method of claim 152, further comprising severing the flexible elongate member adjacent the securing element.

154. The method of claim 139, wherein actuating the securing element to permanently secure the position of the right atrial anchor includes causing a portion of the securing element connected to the right atrial anchor to grippingly engage the flexible elongate member.

155. A method of closing a patent foramen ovale (PFO) track having a left atrial end and a right atrial end, the method comprising:

positioning a first anchor on the left atrial end of the PFO track, the first anchor being connected to an elongate member that extends proximally;

positioning a second anchor on the right atrial end of the PFO track, the second anchor being movable along the elongate member; and

advancing a securing element in a distal direction along the elongate member from a position proximal to the second anchor to a position adjacent to the second anchor to secure the position of the second anchor relative to the elongate member.

156. The method of claim 155, further comprising advancing a sheath containing the first and second anchors, the elongate member, and the securing element in a delivery configuration into the heart, wherein a central hub of the first anchor abuts a central hub of the second anchor in the delivery position.

157. The method of claim 156, wherein positioning the first anchor includes advancing the sheath through the PFO track and into the left atrium of the heart.

158. The method of claim 157, wherein positioning the first anchor further includes advancing the first anchor out of the sheath and into the left atrium.

159. The method of claim 158, further including expanding the first anchor from the delivery configuration to a deployed configuration.

160. The method of claim 155, wherein positioning the first anchor includes pulling the flexible elongate member in a proximal direction to seat the first anchor against the septum primum.

161. The method of claim 160, wherein positioning the first anchor further includes pulling the flexible elongate member in a proximal direction to seat the first anchor against the septum primum and the septum secundum.

162. The method of claim 157, further comprising withdrawing the sheath containing the second anchor, the elongate member, and the securing element through the PFO track and into the right atrium of the heart subsequent to positioning the first anchor on the left atrial end of the PFO track.

163. The method of claim 162, wherein positioning the second anchor includes advancing the second anchor out of the sheath and into the right atrium.

164. The method of claim 163, further including expanding the second anchor from the delivery configuration to a deployed configuration.

165. The method of claim 164, wherein positioning the second anchor further includes moving the second anchor along the flexible elongate member to a desired position on the elongate member adjacent to the right atrial end of the PFO track.

166. The method of claim 155, wherein a portion of the flexible elongate member is configured to remain implanted with the first and second anchors, and wherein advancing the securing element in the distal direction along the elongate member to a position adjacent to the second anchor includes advancing the securing element to a position at any point along a length of the portion of the flexible elongate member configured to remain implanted with the first and second anchors.

167. The method of claim 155, further comprising severing the flexible elongate member adjacent the securing element subsequent to advancing the securing element in a distal direction along the elongate member from a position proximal to the second anchor to a position adjacent to the second anchor.

168. A method for closing a patent foramen ovale (PFO) track in a heart of a patient, the method comprising:

positioning a distal anchor in a left atrium of the heart, the distal anchor connected to an elongate member, and the elongate member extending proximally to the outside of the patient;

positioning a proximal anchor in a right atrium of the heart, the proximal anchor including a central portion through which the elongate member passes;

securing the position of the proximal anchor relative to the elongate member; and

cutting the elongate member at a position proximal to the proximal anchor.

169. The method of claim 168, wherein positioning the distal anchor includes advancing the distal anchor out of a delivery sheath and into the left atrium.

170. The method of claim 169, further including expanding the distal anchor from a delivery configuration to a deployed configuration.

171. The method of claim 170, wherein positioning the distal anchor further includes pulling the flexible elongate member in a proximal direction to seat the deployed distal anchor against the septum primum.

172. The method of claim 168, wherein positioning the proximal anchor includes advancing the proximal anchor out of a delivery sheath and into the right atrium.

173. The method of claim 172, further including expanding the proximal anchor from a delivery configuration to a deployed configuration.

174. The method of claim 173, wherein positioning the proximal anchor further includes moving the proximal anchor along the flexible elongate member to a desired position on the elongate member adjacent to a right atrial end of the PFO track.

175. The method of claim 168, wherein securing the position of the proximal anchor relative to the elongate member includes advancing a securing element out of a delivery sheath and along the elongate flexible member.

176. The method of claim 175, wherein securing the position of the proximal anchor further includes moving the securing element along the elongate member from a position proximal to the proximal anchor to a position adjacent to the proximal anchor.

177. The method of claim 175, wherein a portion of the flexible elongate member is configured to remain implanted with the proximal and distal anchors, and wherein securing the position of the proximal anchor further includes positioning the securing element adjacent to the proximal anchor at any point along a length of the portion of the flexible elongate member configured to remain implanted with the proximal and distal anchors.

178. The method of claim 168, wherein cutting the elongate member at a position proximal to the proximal anchor includes cutting the elongate member at a position proximal to a securing element positioned adjacent to the proximal anchor.

179. The method of claim 176, wherein cutting the elongate member at a position proximal to the proximal anchor includes cutting the elongate member at a position proximal to the securing element.

180. The method of claim 177, wherein cutting the elongate member at a position proximal to the proximal anchor includes cutting the elongate member at a position proximal to the securing element.

181. A method of sealing a passageway in a heart, comprising:

positioning a first anchor proximate a first end of the passageway;

moving a second anchor away from the first anchor and through the passageway along an elongate member connected to the first anchor;

positioning the second anchor proximate a second end of the passageway;

advancing a securing element along the elongate member toward the second anchor; and

securing the position of the second anchor relative to the elongate member.

182. The method of claim 181, wherein positioning the first anchor includes advancing the first anchor out of a delivery sheath and into a first chamber of the heart.

183. The method of claim 182, further including expanding the first anchor from a delivery configuration to a deployed configuration.

184. The method of claim 183, wherein positioning the first anchor further includes pulling the flexible elongate member in a proximal direction to seat the deployed first anchor against the first end of the passageway

185. The method of claim 181, wherein moving the second anchor away from the first anchor and through the passageway along an elongate member connected to the first anchor includes withdrawing a delivery device containing the second anchor proximally through the passageway and into a second chamber of the heart.

186. The method of claim 185, wherein positioning the second anchor includes advancing the second anchor out of the delivery device and into the second chamber of the heart.

187. The method of claim 186, further including expanding the second anchor from a delivery configuration to a deployed configuration.

188. The method of claim 187, wherein positioning the second anchor further includes moving the second anchor along the flexible elongate member to a desired position on the elongate member adjacent to the second end of the passageway.

189. The method of claim 181, wherein securing the position of the second anchor includes moving the securing element along the elongate member from a position proximal to the second anchor to a position adjacent to the second anchor.

190. The method of claim 181, wherein a portion of the flexible elongate member is configured to remain implanted with the first and second anchors, and wherein securing the position of the second anchor includes positioning the securing element adjacent to the second anchor at any point along a length of the portion of the flexible elongate member configured to remain implanted with the first and second anchors.

191. The method of claim 181, further comprising cutting the flexible elongate member at a position proximal to the second anchor.

192. The method of claim 191, wherein cutting the flexible elongate member at a position proximal to the second anchor includes cutting the elongate member at a position proximal to the securing element.

193. A device for sealing a passageway in a human body, the device comprising:

a first anchor configured to be placed proximate a first end of the passageway;

a second anchor configured to be placed proximate a second end of the passageway;

an elongate member configured to extend through the passageway and connect the first and second anchors, wherein at least a portion of the elongate member is configured to remain implanted in the body with the device; and

a securing element positionable on and movable relative to the elongate member to secure the location of the second anchor at any point along a length of the portion of the elongate member configured to remain implanted in the body with the device.

194. The device of claim 193, wherein the passageway is a patent foramen ovale.

195. The device of claim 193, wherein the elongate member is flexible.

196. The device of claim 193, wherein the first anchor includes a plurality of arms radiating from a first central hub.

197. The device of claim 196, wherein the plurality of arms of the first anchor can assume a collapsed state and a deployed state.

198. The device of claim 193, wherein the second anchor includes a plurality of arms radiating from a second central hub.

199. The device of claim 198, wherein plurality of arms of the second anchor can assume a collapsed state and a deployed state.

200. The device of claim 193, wherein the first anchor pivots relative to the elongate member.

201. The device of claim 193, wherein the second anchor pivots relative to the elongate member.

202. The device of claim 193, wherein the elongate member is capable of moving through the second anchor to vary a length of the elongate member between the first and second anchors.

203. The device of claim 193, wherein the second anchor is movable with respect to the elongate member.

204. The device of claim 193, wherein the elongate member is configured to move through the second anchor to vary a tension of the elongate member.

205. The device of claim 193, wherein the securing element is movable in only one direction along the elongate member.

206. The device of claim 193, wherein the second anchor includes a cover spanning between its plurality of arms.

207. The device of claim 206, wherein the first anchor does not include structure spanning between its plurality of arms.

208. The device of claim 193, wherein the elongate member has sufficient flexibility to conform to a shape of the passageway.

209. The device of claim 193, wherein the plurality of arms of the first anchor are made of a first material and the elongate member is made of a second material different from the first material.

210. The device of claim 209, wherein the plurality of arms of the second anchor are made from the first material.

211. The device of claim 193, wherein the elongate member is a braided structure.

212. The device of claim 193, wherein the elongate member is a multifilar structure.

213. A method for closing a patent foramen ovale (PFO) track having a left atrial end and a right atrial end, the method comprising:

advancing a sheath through the PFO track;

advancing a closure device in an undeployed configuration through the sheath to a position proximate a distal end of the sheath, the closure device comprising a distal anchor, a proximal anchor, and an elongate member, a distal end of the elongate member being secured to the distal anchor, the elongate member extending proximally through said proximal anchor, wherein the proximal and distal anchors are in an abutting relationship in the undeployed configuration;

deploying the distal anchor in the left atrium;

retracting the proximal anchor and the sheath in a proximal direction along the elongate member and through the PFO track into the right atrium; and

deploying the proximal anchor in the right atrium.

214. The method of claim 213, wherein advancing the sheath through the PFO track includes advancing the sheath until a distal end of the sheath is in the left atrium.

215. The method of claim 213, wherein deploying the distal anchor in the left atrium includes advancing the distal anchor and the distal end of the elongate member out of the distal end of the sheath.

216. The method of claim 213, wherein retracting the proximal anchor and the sheath in a proximal direction includes moving the proximal anchor relative to the elongate member.

217. The method of claim 213, wherein retracting the proximal anchor and the sheath in a proximal direction includes positioning a portion of the elongate member in the PFO track.

218. The method of claim 213, wherein retracting the proximal anchor and the sheath in a proximal direction includes advancing the elongate member out of the distal end of the sheath.

219. The method of claim 213, wherein deploying the proximal anchor in the right atrium includes moving the sheath proximally relative to the proximal anchor and elongate member to advance the proximal anchor out of the distal end of the sheath.

220. The method of claim 219, wherein deploying the proximal anchor in the right atrium further includes advancing the proximal anchor along the elongate member in a distal direction.

221. The method of claim 213, further comprising positioning the distal anchor adjacent the left atrial end of the PFO track.

222. The method of claim 221, wherein positioning the distal anchor adjacent the left atrial end of the PFO track includes, subsequent to deploying the distal anchor in the left atrium, moving the distal anchor and the distal end of the elongate member in a proximal direction within the left atrium.

223. The method of claim 213, further comprising positioning the proximal anchor adjacent the right atrial end of the PFO track.

224. The method of claim 223, wherein positioning the proximal anchor adjacent the right atrial end of the PFO track includes, subsequent to deploying the proximal anchor in the right atrium, moving the proximal anchor in a distal direction along the elongate member within the right atrium.

225. The method of claim 224, further comprising fixing the location of the proximal anchor relative to the elongate member.

226. The method of claim 225, wherein fixing the location of the proximal anchor relative to the elongate member includes, subsequent to positioning the proximal anchor, deploying a securing element in the right atrium.

227. The method of claim 226, wherein deploying the securing element includes advancing the securing element along the elongate member toward the proximal anchor.

228. The method of claim 227, further comprising cutting the elongate member proximal to the securing element.