Devices and methods for heart valve treatment

• US 20060041306A1
• Filed: 07/01/2005
• Published: 02/23/2006
• Est. Priority Date: 01/09/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., Mortier, Todd J., Schweich, Cyril J. Jr., Schroeder, Richard, Kalgreen, Jason E., Kusz, David
• Granted Patent: US 7,678,145 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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

Devices and methods for treating heart valves include members that assist the valve in closing during at least a portion of the cardiac cycle. Such devices include members configured to alter the shape of a valve annulus, reposition at least one papillary muscle, and/or plug an orifice of the valve so as to provide a coaptation surface for the valve leaflets.

Claims

1-167. -167. (canceled)

168. A method of performing transluminal mitral annuloplasty, comprising the steps of:

providing a catheter, having a prosthesis thereon;

inserting the catheter into a venous system;

transluminally advancing the prosthesis into a coronary sinus;

advancing at least one tissue anchor from a retracted position to an extended position; and

manipulating a component of the prosthesis to cause the prosthesis to exert force on a mitral valve annulus.

169. A method as in claim 168, further comprising the step of percutaneously accessing the venous system prior to the transluminally advancing step.

170. A method as in claim 169, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian and femoral veins.

171. A method as in claim 168, further comprising the step of measuring hemodynamic function following the manipulating a component of the prosthesis step.

172. A method as in claim 168, wherein the advancing at least one tissue anchor step comprises advancing the anchor from an axial orientation to an inclined orientation.

173. A method as in claim 172, wherein the tissue anchor has a proximal end for piercing tissue and a distal point of attachment to the prosthesis, and the advancing at least one tissue anchor step comprises rotating the anchor about the point of attachment.

174. A method as in claim 168, comprising advancing at least two tissue anchors to an extended position.

175. A method as in claim 173, comprising advancing at least two tissue anchors to an extended position.

176. A method as in claim 168, wherein the manipulating a component of the prosthesis step causes the prosthesis to transform into a curved configuration having a first side facing towards the mitral valve annulus and a second side facing away from the mitral valve annulus.

177. A method as in claim 176, additionally comprising the step of advancing at least two tissue anchors in the direction of the mitral valve annulus.

178. A method as in claim 168, wherein the manipulating step comprises axially moving a forming element with respect to the prosthesis, to bend the prosthesis.

179. A method as in claim 171, wherein the step of monitoring hemodynamic function is accomplished using echo cardiography.

180. A method of performing annuloplasty of the mitral valve comprising positioning a prosthesis in the coronary sinus;

rotating a first portion of the device with respect to a second portion of the device to cause the device to bend into an arcuate configuration having a proximal concavity and a distal concavity both concave toward the mitral valve and a central concavity concave away from the mitral valve, to provide a compressive force on the mitral valve annulus; and

securing the device in the arcuate configuration within the coronary sinus.

181. A method as in claim 180, further comprising the step of percutaneously accessing the venous system prior to the positioning step.

182. A method as in claim 181, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian and femoral veins.

183. A method as in claim 180, further comprising the step of measuring hemodynamic function following the rotating step.

184. A medical apparatus for remodeling a mitral valve annulus adjacent to the coronary sinus, comprising:

an elongate body, having a proximal end region and a distal end region, each of the proximal and distal end regions configured to move between a first, flexible configuration for transluminal delivery to at least a portion of the coronary sinus and a second remodeling configuration in which each of the proximal and distal end regions forms a curve which is open in the direction of the mitral valve; and

a forming element for manipulating the elongate body between the first transluminal configuration and the second remodeling configuration.

185. A medical apparatus as in claim 184, wherein the elongate body comprises a tube having a plurality of transverse slots therein.

186. A medical apparatus as in claim 185, wherein the elongate body transforms into the remodeling configuration by changing the width of the slots.

187. A medical apparatus as in claim 184, wherein the apparatus is movable from the implantation configuration to the remodeling configuration in response to proximal retraction of the forming element.

188. A medical apparatus as in claim 184, further comprising an anchor for retaining the apparatus at a deployment site within a vessel.

189. A medical apparatus as in claim 188, wherein the anchor comprises a distal extension of the apparatus.

190. A medical apparatus as in claim 188, wherein the anchor comprises a surface structure for engaging the wall of the vessel.

191. A medical apparatus as in claim 184, wherein the anchor comprises at least one barb for piercing the wall of the vessel.

192. A medical apparatus as in claim 191, comprising a first barb on the proximal end region and a second barb on the distal end region.

193. A method of reducing the circumference of a mitral valve annulus comprising the steps of:

providing a mitral valve reducing device comprising an elongate member;

positioning the elongate member in a first position at a location adjacent the atrioventricular groove and exterior of the vasculature of the heart, wherein in the first position, the elongate member has a first radius of curvature; and

releasing the elongate member in the atrioventricular groove in a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature so as to reduce the circumference of the mitral valve annulus.

194. The method of claim 193 wherein the step of positioning the elongate member in a first position comprises delivering the elongate member along a coronary sinus to the location adjacent the atrioventricular groove.

195. The method of claim 193 wherein the step of positioning the elongate member in a first position comprises delivering the elongate member through a coronary sinus vessel, forming an opening in the coronary sinus and delivering the elongate member out of the coronary sinus through the opening.

196. The method of claim 193 wherein the step of positioning the elongate member in a first position comprises accessing and navigating the pericardial space.

197. The method of claim 193 wherein the step of releasing the elongate member in the atrioventricular groove in a second position comprises bending the elongate member from the first position into the second position.

198. The method of claim 197 wherein the step of providing an elongate member comprises providing an elongate member comprising a cinching mechanism;

and wherein the step of bending the elongate member comprises actuating the cinching mechanism.

199. The method of claim 198 wherein the step of providing an elongate member comprises providing an elongate member having a preferential bending mechanism at a location along a length of the elongate member;

and wherein the step of bending the elongate member comprises bending the elongate member at the location.

200. The method of claim 193 further comprising the step of increasing tissue adherence to the elongate member.

201. The method of claim 200 wherein the step of increasing tissue adherence occurs prior to releasing the elongate member in the atrioventricular groove in the second position.

202. The method of claim 200 wherein the step of increasing the tissue adherence comprises:

providing a coating on the elongate member to cause a tissue response.

203. The method of claim 202 wherein the step of providing a coating comprises providing a coating comprising a tissue growth promoter to cause tissue growth around the elongate member.

204. The method of claim 193 wherein the elongate member comprises an inflammatory response material.

205. A system for reducing the mitral annulus of a heart comprising:

a mitral valve reducing device comprising;

an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature, and a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature; and

a delivery system comprising;

a catheter configured to access a pericardial space of a heart, adjacent an atrioventricular groove and outside of vasculature of the heart; and

a mitral valve reducing device delivery member configured to place the reducing device in the atrioventricular groove.

206. The system of claim 205 wherein the mitral valve reducing device comprises a cinching mechanism for bending the elongate member;

and wherein bending the elongate member comprises actuating the cinching mechanism.

207. The system of claim 205 wherein the mitral valve reducing device comprises a preferential bending mechanism at a location along a length of the elongate member.

208. A mitral valve reduction device comprising:

an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature, a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature, and a bending mechanism configured to move the elongate member from the first position to the second position; and

a coating on the elongate member, wherein the coating comprises a tissue response promoter for promoting a tissue response adjacent the elongate member.

209. The mitral valve reduction device of claim 208 wherein the coating comprises a tissue growth promoter.

210. The mitral valve reduction device of claim 208 wherein the elongate member comprises a tissue inflammation promoter.

211. A mitral valve reduction device comprising:

an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature and a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature; and

an end comprising a tissue engaging element configured to engage the heart within the atrioventricular groove.

212. The mitral valve reduction device of claim 211 wherein the tissue engaging element comprises at least one finger member extending from the end of the elongate member.

213. The mitral valve reduction device of claim 211 further comprising:

a bending mechanism configured to move the elongate member from the first position to the second position.