Methods and devices for improving cardiac function in hearts

• US 20070112244A1
• Filed: 04/14/2006
• Published: 05/17/2007
• Est. Priority Date: 01/02/1997
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Schweich, Cyril, Mortier, Todd, Keith, Peter, McCarthy, Patrick, Kallok, Michael
• Application Number:
  US11/404,092
• Publication Number:
  US 20070112244A1
• Time in Patent Office: Days
• US Class Current: 600/16
• 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 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• 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 17/1227 Spring clips
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• 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: A61B 2090/392 Radioactive markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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

Various methods and devices are disclosed for improving cardiac function in hearts having zones of infarcted (akinetic) and aneurysmal (dyskinetic) tissue regions. The methods and devices reduce the radius of curvature in walls of the heart proximal infarcted and aneurysmal regions to reduce wall stress and improve pumping efficiency. The inventive methods and related devices include splinting of the chamber wall proximal the infarcted region and various other devices and methods including suture and patch techniques.

Claims

1-77. -77. (canceled)

78. A method of direct localized therapeutic treatment of a heart, the method comprising:

identifying a target region of the myocardium of the heart; and

applying a self-anchoring mechanical device directly to a portion of the myocardial tissue of the identified target region,

whereby motion of the myocardial tissue of the identified target region is at least one of;

restricted and limited.

79-83. -83. (canceled)

84. A method of treating a heart having experienced a myocardial infarction, the method comprising:

identifying and locating at least one of;

non-ischemic tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue in the myocardium of the heart; and

placing a self-anchoring mechanical device in at least one of the non-ischemic tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue to restrict or limit motion in at least one of the infarcted tissue, peri-infarcted tissue and ischemic tissue.

85-98. -98. (canceled)

99. A method of treating a heart with abnormal heart wall motion, the method comprising:

identifying and locating at least one of;

non-ischemic tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue in the myocardium of the heart; and

placing a self-anchoring mechanical device in at least one of the non-ischemic tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue to restrict or limit motion in at least one of the infarcted tissue, peri-infarcted tissue and ischemic tissue.

100-101. -101. (canceled)

102. A device for placement in a myocardium of a heart, the device comprising:

means for attaching to the myocardium at two or more attachment locations; and

means for restricting, to substantially a predetermined value, a distance between at least two attachment locations.

103-109. -109. (canceled)

110. A device for reducing stress in myocardial tissue, comprising:

a substantially tubular body having proximal and distal portions;

a first expanding anchor located at the proximal portion; and

a second expanding anchor located at the distal portion, wherein the tubular body comprises a lumen having a proximal opening in the proximal portion and a distal opening in the distal portion.

111-121. -121. (canceled)

122. A method of direct localized therapeutic treatment of a heart, the method comprising:

identifying a target region of the myocardium of the heart; and

applying a self-anchoring mechanical device directly to a portion of the myocardial tissue of the identified target region to limit substantial lengthening of myocytes in the target region.

123-126. -126. (canceled)

127. A method of treating mitral valvular regurgitation in a human heart, the method comprising:

providing a self-anchoring mechanical device;

identifying a target region of a myocardium of the heart; and

positioning the self-anchoring mechanical device within a portion of the identified target region so as to adjust a position of a base of at least one papillary muscle coupled to a mitral valve.

128-138. -138. (canceled)

139. A method of treating mitral valvular regurgitation, the method comprising:

providing a restraining device having a distal anchor and a proximal anchor;

embedding the distal anchor of the device in heart tissue; and

embedding the proximal anchor in the heart tissue, wherein the restraining device is substantially positioned in a mid-wall of the heart and oriented to adjust a position of a base of at least one papillary muscle coupled to a mitral valve.

140-145. -145. (canceled)

146. A method of treating a heart, the method comprising:

providing a restraining device having a distal anchor and a proximal anchor;

embedding the distal anchor of the device in heart tissue; and

embedding the proximal anchor in the heart tissue, wherein the restraining device is substantially positioned in a mid-wall of the heart.

147-153. -153. (canceled)

154. A method for direct localized therapeutic treatment of myocardial tissue in heart having a pathological condition comprising the steps of:

a. identifying a target region of the myocardium;

b. applying a device to at least a portion of the myocardial tissue of the target region substantially identified in step (a) to physically modify the mechanical properties of said tissue and limit motion in the peri-infarct or infarct region.

155. The method of claim 154, wherein geometry and wall stress of the infarct or peri-infarct tissue is altered.

156. The method of claim 155, wherein the infarct region is excluded or shrunk.

157. The method of claim 156, wherein expansion of the infarct or peri-infarct tissue during systole is limited.

158. The method of claim 154, wherein the infarct or peri-infarct tissue is physically modified by at least one of stiffening, restraining, or constraining.

159. The method of claim 154, wherein a device is placed through the myocardium to restrict motion in the peri-infarct or infarct regions.

160. The method of claim 154, wherein the modified mechanical properties include an increase in systolic performance.

161. The method of claim 160, wherein the modified mechanical properties includes substantially no decrease in global diastolic performance.

162. The method of claim 154, wherein the device is utilized without external stimulation.

163. The method of claim 154, wherein the target region includes a myocardial infarct.

164. The method of claim 154, wherein the target region at least in part underlies the papillary muscles associated with a cardiac valve.

165. The method of claim 164, wherein said cardiac valve is the mitral valve.

166. The method of claim 154, wherein the device is a tubular structure positioned between at least first and second anchors.

167. The method of claim 166, wherein the tubular structure includes slots configured to provide lateral flexibility.

168. The method of claim 167, wherein the tubular structure is configured to provide lateral and longitudinal flexibility.

169. The method of claim 168, wherein the tubular structure is configured to provide lateral shortening and limited lateral lengthening.

170. The method of claim 166, wherein the at least first and second anchors are end portions of the tubular structure.

171. The method of claim 154, wherein said applying step includes employing a guide catheter.

172. The method of claim 171, wherein the guide catheter is inserted through the femoral artery, threaded through the aorta and inserted retrograde through the aortic valve into the left ventricle.

173. The method of claim 172, wherein the guide catheter is placed against the endocardial surface of the left ventricle.

174. The method of claim 173, further comprising:

placing a puncture device through the guide catheter to make a puncture into the endocardium.

175. The method of claim 174, further comprising:

inserting a guidewire until it is located distal to the myocardial infarct and the distal peri-infarct region.

176. The method of claim 175, further comprising:

introducing the delivery device over the guidewire to the desired location in the myocardium.

177. The method of claim 171, wherein said catheter is employed percutaneously.

178. The method of claim 154, wherein said applying step is preceded by performing a minithoractomy.

179. The method of claim 154, wherein said applying step includes applying material intramyocardially.