Source: http://www.google.com/patents/US7087064?dq=7,117,286
Timestamp: 2014-09-23 16:46:33
Document Index: 438488813

Matched Legal Cases: ['art 110', 'art 110', 'art 110', 'art 110', 'art 110', 'art 110']

Patent US7087064 - Apparatuses and methods for heart valve repair - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsA medical device for treating a heart having a faulty heart valve is disclosed. The medical device comprises a ligature including a first anchoring member and a second anchoring member is used. The ligature is percutaneously deployable into a patient with a faulty heart valve wherein the first anchoring...http://www.google.com/patents/US7087064?utm_source=gb-gplus-sharePatent US7087064 - Apparatuses and methods for heart valve repairAdvanced Patent SearchPublication numberUS7087064 B1Publication typeGrantApplication numberUS 10/272,060Publication dateAug 8, 2006Filing dateOct 15, 2002Priority dateOct 15, 2002Fee statusPaidAlso published asUS7740638, US8133272, US20060030885, US20070050019, US20100222876Publication number10272060, 272060, US 7087064 B1, US 7087064B1, US-B1-7087064, US7087064 B1, US7087064B1InventorsGregory Mathew HydeOriginal AssigneeAdvanced Cardiovascular Systems, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (120), Non-Patent Citations (3), Referenced by (28), Classifications (26), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetApparatuses and methods for heart valve repairUS 7087064 B1Abstract A medical device for treating a heart having a faulty heart valve is disclosed. The medical device comprises a ligature including a first anchoring member and a second anchoring member is used. The ligature is percutaneously deployable into a patient with a faulty heart valve wherein the first anchoring member to anchor to a first tissue area of the heart and the second anchoring member to anchor to a second tissue area of the heart.
FIGS. 9�10 are illustrations of a perspective view of the medical device shown in FIG. 6 wherein a ligature is being deployed from the delivery shaft;
FIGS. 11A�11B illustrate another exemplary embodiment of a medical device that includes a delivery device which is used to percutaneously deploy a ligature into a patient to constrict a heart valve;
FIGS. 12F�12G are illustrations of a distal end of the medical device shown in FIG. 6 with a ligature having helix ends as anchoring members;
FIGS. 13A�13H are illustrations of an exemplary embodiment of a method to deploy a ligature or ligatures in accordance with the present invention;
FIGS. 15A�15D are illustrations of an exemplary embodiment where a medical device made in accordance with the present invention can be inserted percutaneously into a coronary sinus; and
In one embodiment, the medical device 301 comprises a delivery shaft 300 having a delivery lumen 305 (FIGS. 7�8), a proximal end 322, and a distal end 324. In one embodiment, the delivery shaft 300 is a catheter, which is sized and shaped as generally known in the art to travel within and along the vascular tree to the heart of a patient. A first deployment shaft 310A and a second deployment shaft 310B are disposed within the delivery lumen 305 and extend from the distal end 324 to the proximal end 322. A ligature 100 is releasably coupled to the delivery shaft 300 at the distal end 324 such that the ligature 100 is coupled to the delivery shaft 300 for deployment, and after deployment, the ligature 100 is released from the delivery shaft 300. The ligature 100 includes a first anchoring member 102A and a second anchoring member 102B and the ligature 100 links them as previously described. The medical device 301 can deploy the ligature 100 into a patient wherein the first deployment shaft 310A deploys the first anchoring member 102A to a first tissue area of the patient (e.g., a cardiac tissue, a tissue proximate a mitral valve, or a portion of the mitral valve) and the second deployment shaft 310B deploys the second anchoring member 102B to a second tissue area of the patient (e.g., another cardiac tissue, another tissue proximate a mitral valve, or another portion of the mitral valve).
In one embodiment, the delivery shaft 300 also includes a guide wire lumen 320 as shown in FIGS. 7�8. The guide wire lumen 320 extends from the distal end 324 of the delivery shaft 300 to the proximal end 322 of the delivery shaft 300, through the handle member 340, and is connected to a guide wire port 360 in the proximal end of the handle member 340. The guide wire lumen 320 is sufficiently sized and shaped to allow for the insertion of a guide wire (not shown). The guide wire may be disposed through the guide wire lumen 320 to guide or maneuver the delivery shaft 300 from the entrance of the patient's body through the body of the patient to reach the area of the heart where the ligature 100 will be deployed, e.g., a mitral valve. In one embodiment, the guide wire port 360 is used to control the advancement, movement, or steering of the guide wire through the patient's body.
In another embodiment, a supporting member may consist of a member (not shown) that is coupled to the distal end 324 of a steering lumen included within the delivery shaft 300. The steering lumen can be the guidewire lumen 320 shown in FIGS. 7�8. The supporting member may extend from the distal end 324 to the proximal end 322 of the delivery shaft 300. In one embodiment, pulling on this supporting member at the proximal end 322 causes the distal end 324 of the delivery shaft to become curved. In another embodiment, the steering lumen is pressurized causing the distal end 324 of the delivery system to bend in a desired direction.
FIG. 9 illustrates a perspective view of the medical device 301 wherein the delivery shaft 300 is deploying the ligature 100 that is releasably coupled to the delivery shaft 300. In one embodiment, the medical device 301 is used to deploy the ligature 100 to place the ligature 100 across the mitral valve as illustrated in FIGS. 4�5. The medical device 301 can be used to deploy the ligature 100 to other area of the heart, for example, within a coronary sinus (see FIG. 15A) or over the left ventricle of the heart (see FIGS. 14B and 14C).
The medical devices 301 shown in FIGS. 6�8 and 9�10 include the ligature 100 that has barbed end configurations for the anchoring members 102A and 102B. It is to be appreciated that the anchoring members 102A and 102B may have other configurations, for examples, helixes, or hooks as shown in FIGS. 2B and 3.
FIGS. 11A�11B illustrate an exemplary medical device 302. The medical device 302 is similar to the medical device 301 except that the device 302 is more preferred for delivering a ligature 100 that has helix ends as the anchoring members. As illustrated in FIGS. 11A�11B, the medical device 302 comprises a delivery shaft 303 having a delivery lumen 318, a proximal end 332, and a distal end 334. In one embodiment, the delivery shaft 303 is a catheter, which is sized and shaped as generally known in the art to travel within and along the vascular tree to the heart of a patient. In another embodiment, the delivery shaft 303 is the same as the delivery shaft 300.
In one embodiment, the delivery shaft 303 also includes a guide wire lumen 312 as illustrated in FIGS. 11A�11B. The guide wire lumen 312 extends from the distal end 334 of the delivery shaft 303 to the proximal end 332 of the delivery shaft 303, and through the handle member 304 and is connected to a guide wire port 330 located at the proximal end of the handle member 304. The guide wire lumen is sufficiently sized and shaped to allow for the insertion of a guide wire (not shown). The guide wire may be disposed through the guide wire lumen 312 to guide or maneuver the delivery shaft 303 through the body of the patient to reach the area of the heart where the ligature 100 is to be deployed, e.g., a mitral valve. In one embodiment, the guide wire port is used to control the advancement, movement, or steering of the guide wire through the patient's body.
In another embodiment, a supporting member may consist of a member (not shown) that is coupled to the distal end 334 of a steering lumen included within the delivery shaft 303. The steering lumen can be the guidewire lumen 312 shown in FIGS. 11A�11B. The supporting member may extend from the distal end 334 to the proximal end 332 of the delivery shaft 303. In one embodiment, pulling on this supporting member at the proximal end 332 causes the distal end 334 of the delivery shaft to become curved. In another embodiment, the steering lumen is pressurized causing the distal end of the delivery system to bend in a desired direction.
FIGS. 12A�12G illustrate an exemplary deployment shaft that can be used with the medical device 302 to deploy the ligature 100. The deployment shaft can be the deployment shaft 307 or 309 shown in FIGS. 11A�11B. In one embodiment, the deployment shaft 307 shown in FIG. 12A is disposed within the deployment tube 336 as shown in FIG. 12B. In one embodiment, the deployment shaft 307 includes a slot 342 wherein a portion of the ligature 100 can reside until deployment. The slot 342 is useful in that it helps keep the ligature 100 from being entangled between two deployment shafts 307 and 309. The slot 342 is not necessary for the deployment shaft 307 or 309 to function properly in deploying the ligature 100.
In one embodiment, the distal end of the deployment shaft 307 further comprises an axis 344 such that the helix anchoring member 104A can be kept there or releasably coupled thereto until the deployment of the ligature 100. The deployment shaft 307 with the ligature 100 releasably coupled thereto can be disposed within the deployment tube 336 as illustrated in FIG. 12E. FIGS. 12F�G further illustrates the distal end 334 of the delivery shaft 302 wherein the deployment shafts 307 and 309 are disposed within the deployment tube 336 and 338, respectively.
FIGS. 13A�13H illustrate an exemplary process of deploying the ligature 100 that includes helix ends anchoring members. At FIGS. 13A�13B, the deployment tube 336 is advanced in order to advance the deployment shaft 307 (not visible in these figures) toward a tissue area 344. Advancing the deployment shaft 307 would advance the helix ends 104A toward the tissue area 344. In one embodiment, the deployment tube 336 is advanced toward the tissue area 344 by a deployment mechanism, such as the deployment mechanism 350A shown in FIG. 11. After the advancement, the deployment shaft 307 is then rotated by a rotating mechanism such as the rotating mechanism 314 shown in FIG. 11. In this case, the linkage portion of the ligature 100 which joins the two anchoring members, the helix ends 104A and 104B, is flexible and twistable so that one helix end can be rotated while the other helix end is not. As the deployment shaft 307 is rotated, the helix end 104A is also rotated allowing it to pierce through the tissue area 344 as illustrated in FIG. 13C. In one embodiment, upon advancing, the helix end 104A is rotated in a direction that would enhance the advancement of the helix end 104A into the tissue area 344. The rotation of the deployment shaft 307 is initiated by a rotation of the rotating mechanism. Once the helix end 104A is anchored to the tissue area 344, the deployment tube 336 together with the shaft 307 is retracted into the delivery shaft 303 leaving the helix end 104A embedded (or anchored) in the tissue area 344 as illustrated in FIG. 13D. This process can be repeated for the helix end 104B of the ligature 100.
As shown in FIGS. 13D�13E, the deployment tube 338 is advanced out of the delivery shaft 303 to advance the deployment shaft 309 to a tissue area 346. Advancing the deployment shaft 309 would advance the helix end 104B toward the tissue area 346. After the advancement, the deployment shaft 309 is rotated by a rotating mechanism such as the rotating mechanism 316 shown in FIG. 11. As the deployment shaft 309 is rotated, the helix end 104B is also rotated allowing it to pierce through the tissue area 346 as illustrated in FIGS. 13E�F. In one embodiment, upon advancing, the helix end 104B is rotated in a direction that would enhance the advancement of the helix end 104B into the tissue area 346. Once the helix end 104B is anchored to the tissue area 346 as shown in FIG. 13F, the deployment shaft 309 is retracted into the delivery shaft 303 leaving the helix end 104B embedded in the tissue area 346 as illustrated in FIGS. 3G�H.
After the helix ends 104A and 104B are anchored to the tissue area 344 and 346, respectively, the delivery shaft 303 may then be retracted from the tissue area 344 and 346. The process described in FIGS. 13A�13H may be repeated as needed to deploy as many ligatures 100 as necessary. In one embodiment, the process is used to constrict a heart valve such as a mitral valve by placing multiple ligatures 100 across the mitral valve's annulus. In one embodiment, the tissue area 344 and 346 are the fibrous tissue around the annulus of the mitral valve. The anchoring of the helix ends 104A and 104B thus places the ligature 100 across the heart valve to reduce or constrict the size of the heart valve. The ligatures 100 with the helix ends can be placed across the mitral valve using this process to place the ligatures 100 similarly to what is depicted in FIGS. 4 and 5.
In one embodiment, FIG. 14A illustrates an exemplary route of percutaneously inserting the ligatures 100 into the heart 110 and placing the ligatures 100 across the mitral valve 120 of the heart 110. In one embodiment, a medical device containing the ligature 100 is introduced into the patient's body percutaneously using a modified Seldinger technique in which the medical device is inserted into the venous vascular tree through the femoral vein. In one embodiment, the medical device enters or reaches the annulus of the mitral valve 120 from the atrial side of the heart 110. A medical device 130 is first provided. The medical device 130 can be the medial device 301 or the medical device 302 described above. The medical device 130 can also be a catheter capable of delivering and deploying a ligature 100 to the heart. The medical device 130 is advanced up the inferior vena cava (IVC) 122 and into the right atrium (RA) 112 of the heart 110. The medical device 130 then enters then left atrium (LA) 114 of the heart 110. In one embodiment, the medical device 130 crosses the atrial septum 124 through a small atrial septostomy (created by cardiological techniques known in the art) to enter the left atrium 114 of the heart 110. In one embodiment, a guidewire (not shown) is placed across the atrial septostomy and the medical device 130 is threaded along the guidewire and into the left atrium 114. The medical device 130 is stopped at a predetermined point in, at, or in proximity to the mitral valve 120. In one embodiment, the medical device 130 may have a preformed or deflectable short hook configuration at its tip region to facilitate the insertion of the medical device 130 into the mitral valve area. Once the medical device 130 reaches the area in, at, or in proximity to mitral valve 120, the ligature 100 can be deployed as previous described and be placed across the mitral valve in similar manners as those shown in FIGS. 4�5.
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