Device and method for treatment of heart valve regurgitation

CA 02848445 2014-04-08

DEVICE AND METHOD FOR TREATMENT OF HEART VALVE REGURGITATION

BACKGROUND OF THE INVENTION

[0002] The mitral valve is one of the most crucial of the four valves of the human heart, preventing the regurgitation of blood from the left ventricle into the left atrium during contraction of the heart. Located between the left atrium and the left ventricle, the mitral valve includes two leaflets positioned to block blood flow in a closed state while allowing blood flow in an opened state.

[0003] The mitral valve is opened and closed by a pressure differential between the left atrium and left ventricle and by a complex network of collagenous cord-like structures called chordae tendineae that extend from the free edges of the mitral valve leaflets to the papillary muscles on the ventricular wall of the heart. As the papillary muscles contract, they pull on the leaflets and thereby open the mitral valve, allowing blood to flow into the left ventricle. As the papillary muscles relax, the pull on the leaflets is reduced, causing the mitral valve to close and thereby block blood flow into the left ventricle.

[0004] Normal operation of the mitral valve can be impaired when the valve leaflets fail to coapt or fully close, allowing regurgitated blood to flow back into the left atrium. This mitral valve regurgitation is often caused by a congenital valve defect or by changes to the heart geometry due to disease. For example, an infection may cause the mitral valve annulus to enlarge and thereby change the position and orientation of the valve leaflets. In

-1#10940343 V1

CA 02848445 2014-04-08

WO 2006/032051 PCT/US2005/033381 another example, a mitral valve defect may cause prolapse or a mismatch of the leaflets, allowing blood flow to regurgitate back into the left atrium.

[0005] One early approach to treatment of an insufficient mitral valve involved surgical replacement with an artificial valve. In these procedures, open-heart surgery was typically performed on the patient to replace the faulty valve with either a mechanical or biologically derived valve. While this treatment procedure has been improved with time, significant limitations still exist. For example, the removal and replacement of. a mitral valve is highly invasive and therefore greatly increases the risk of serious complications such as infection or rejection.

[0006] Other surgical techniques have been developed to reduce the amount of heart remodeling necessary with valve replacement. One such technique is known as bowtie repair, in which a center region of each mitral valve leaflet is sutured together. Another technique involves creating a placatlon around the valve annulus, thereby reducing the cross-sectional area of the valve annulus. While these techniques require less remodeling than valve replacement, a substantial amount of remodeling is still required. Further, it can be difficult to evaluate the efficacy of the surgical procedure before the conclusion of the surgery.

[0007] In yet another technique, an annuloplasty ring is sewn within the annulus of the mitral valve. Since the diameter of the annuloplasty ring is smaller than the diameter of the mitral valve annulus, the leaflets of the valve are moved together, increasing coaptation. In addition to also being· highly invasive, annuloplasty rings generally distort the natural curved shape of the mitral valve and can further limit the contractility of the annulus.

[0008] While the techniques described above have been used with some success for the treatment of mitral valve deficiencies, additional treatment procedures are needed that require little or no remodeling of the heart. Further, additional treatments are needed that can be performed with minimal invasiveness and yet can more effectively reduce or eliminate mitral valve regurgitation.

-2CA 02848445 2014-04-08

WO 2006/032051 PCT/US2005/033381

OBJECTS AND SUMMARY OF THE INVENTION

[0009] It is an object of the present invention'to overcome the limitations of the prior art.

[0010] It is an object of the present invention to provide an improved method and device for treating mitral valve regurgitation.

[0011] It is another object of the present invention to provide a prosthesis device that reduces regurgitation of blood into the left atrium.

[0012] It is yet another object of thé present invention to provide a prosthesis device that can be delivered and deployed percutaneously within a patient.

[0013] It is another object of the present Invention to provide a prosthesis device that can dynamically fill gaps between mitral valve leaflets.

[0014] It is another object of the present invention to provide a prosthesis device that can reduce most pathologies of mitral valve regurgitation.

[0015] The present invention seeks to achieve these objects, as well as others not specifically enumerated here, by providing a prosthesis that can be implanted within a heart to at least partially block gaps that may be present between the two mitral valve leaflets. In one preferred embodiment, the prosthesis includes an anchoring ring that expands withinthe left atrium to anchor the prosthesis and a pocket member fixed to the anchoring ring. The pocket member is positioned within the mitral valve, between the leaflets so that an open side of the pocket member is positioned within the left ventricle. When the mitral valve is open, blood flows past the pocket member, maintaining the pocket member in a collapsed state. When the mitral valve closes, the backpressure of the blood pushes Into the pocket member, expanding the pocket member to an inflated shape. The mitral valve leaflets contact the expanded pocket member, allowing the prosthesis to block at least a portion of the openings between the leaflets, thereby minimizing regurgitated blood flow into the left atrium.

.-3CA 02848445 2014-04-08

WO 2006/032051

PCT/ÜS2005/033381

[0016] Another preferred embodiment of the present invention provides· device for treating valve regurgitation comprising:

a coaptation member sized for placement at least partially between leaflets of a valve, said coaptation member having an expanded state and a deflated state and having a length substantially equal to a commissure of said leaflets; and an anchoring structure connected to said coaptation member, said anchoring structure having a compressed state sized to fit within a delivery catheter and an expanded state sized for fixation on at least a portion of a wall of a chamber adjacent said valve.

[0017] Another preferred embodiment of the present invention provides a method of treating valve regurgitation comprising:

loading a prosthesis within a delivery catheter, said prosthesis including an anchoring portion and a coaptation portion;

advancing said delivery catheter to a chamber of a heart;

deploying said coaptation portion within a valve;

expanding said anchoring portion to contact a wall of said chamber; and supporting said coaptation portion within a commisure of said valve.

[0018] Another preferred embodiment of the present invention provides a device for substantially blocking, blood flow in a valve during systole comprising:

a flexible member having a lateral dimension;

a support, member coupled to said flexible member and shaped to position said lateral dimension of said flexible member along a commissural length of a leaflet of said valve;

an anchoring member coupled to said support member, said anchoring member including a compressed configuration and an expanded configuration;

wherein said expanded configuration of said anchoring member is shaped to position said support member at least partially within said valve.

-4CA 02848445 2014-04-08

WO 2006/032051 PCT/US2005/033381

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1A illustrates a front view of a prosthesis according to one preferred embodiment of the present invention;

[0020] Figure 1B illustrates a perspective view of the prosthesis of Figure 1A;

[0021] Figure 1C illustrates a profile view of the prosthesis of Figure 1A in an expanded configuration;

[0022] Figure 1D illustrates a profile view of the prosthesis of Figure 1A in an deflated configuration;

[0023] Figure 2A illustrates a bottom view of the prosthesis of Figure 1A in a deflated configuration within a mitral valve;

[0024] Figure 2B illustrates a bottom view of the prosthesis of Figure 1A in an expanded configuration within a mitral valve;

[0025] Figure 3A illustrates a profile view of thè prosthesis of Figure 1A in a deflated configuration within a mitral valve;

[0026] Figure 3B illustrates a profile view of the prosthesis of Figure 1A in an expanded configuration within a mitral valve;

[0027] Figure 4 illustrates a front view of the prosthesis of Figure 1A in a delivery catheter;

[0028] Figure 5A illustrates a front view of a prosthesis according to another preferred embodiment of the present invention;

[0029] Figure 5B illustrates a side view of the prosthesis of Figure 5A;

• [0030] Figure 5C illustrates a perspective view of the prosthesis of Figure 5A;

-5CA 02848445 2014-04-08

WO 2006/032051 PCT/US2005/033381

[0031] Figure 5D illustrates a perspective view of the prosthesis of Figure 5A;

[0032] Figure 6 illustrates a side view of the prosthesis of Figure 5A within a heart;

[0033] Figures 7A and 7B illustrate a side view of the prosthesis of Figure 5A within a delivery catheter;

[0034] Figures 8A and 8B illustrate a side view of the prosthesis of Figure 5A with a retrieval thread;

[0035] Figure 9A illustrates a front view of a prosthesis according to another preferred embodiment of the present invention;

[0036] Figure 9B illustrates a side view of the prosthesis of Figure 9A;

[0037] Figure 9C illustrates a perspective view of the prosthesis of Figure 9A;

[0038] Figure 9D illustrates a perspective view of the prosthesis of Figure 9A;

[0039] Figure 9E illustrates an enlarged view of area’9E in Figure 9D;

[0040] Figure 10A illustrates à front view of a prosthesis according to another preferred embodiment of the present invention;

[0041] Figures 10B-10D illustrate various perspective views of the prosthesis of Figure 10A;

[0042] Figure 11 illustrates a side view of the prosthesis of Figure 10A during deployment from a delivery catheter;

[0043] Figure 12A illustrates a front view of a prosthesis according to another preferred embodiment of the present invention;

[0044] Figure 12B illustrates a side view of the prosthesis of Figure 12A;

-6CA 02848445 2014-04-08

WO 2006/032051 PCT/ÜS2005/033381

[0045] Figures 12C-12E illustrate various perspective views of the prosthesis of Figure 12A;

[0046] Figure 13 illustrates a side view of the prosthesis of Figure 12A within a heart;

[0047] Figure 14A illustrates a front view of a prosthesis according to another preferred embodiment of the present invention; .

[0048] Figure 14B illustrates a side view of the prosthesis of Figure 14A;

[0049] Figure 14C illustrates a top view of the prosthesis of Figure 14A;

[0050] Figures 14D and 14E illustrate various perspective' views of the prosthesis of Figure 14A;

[0051] Figure'.15 illustrates a side view of the prosthesis of Figure 14A within a heart;

[0052] Figures 16A and 16B illustrate side views of the prosthesis of Figure 14A within a delivery catheter;

[0053] Figure 17A illustrates a front view of a prosthesis according to another preferred embodiment of the present invention;

[0054] Figure 17B illustrates a top view of the prosthesis of Figure 17A;

[0055] Figures 17C and 17D illustrate perspective views of the prosthesis of Figure 17A;

[0056] Figure 18A illustrates a front view of a prosthesis according to another preferred embodiment of the present invention;

[0057] Figures 18B and 18C illustrate various perspective views of the prosthesis of Figure 18A;

[0058] Figure 18D illustrates an enlarged view or area 18D in Figures 18B;

-7CA 02848445 2014-04-08

WO 2006/032051 PCT/US2005/033381

[0059] Figure 19A illustrates a front view of a prosthesis according to another preferred embodiment of the present invention;

[0060] Figures 19B and 19C illustrate various perspective views of the prosthesis of Figure 19A;

[0061] Figure 19D illustrates an enlarged view or area 19D in Figures 19B;

[0062] Figure 20A illustrates a front view of a prosthesis according to another preferred embodiment of the present invention;

[0063] Figures 20B and 20C illustrate various perspective views of the prosthesis of Figure 20A;

[0064] Figure 21A illustrates a side view of the prosthesis of Figure 20A in a partially deployed configuration;

[0065] Figure 21B illustrates an enlarged view of area 21B in Figure 21 A;

[0066] Figure 22A illustrates a front view of a prosthesis according to another prefened embodiment of the present invention;

[0067] Figures 22B and 22C illustrate various perspective views of the prosthesis of Figure 22A;

[0068] Figure 23A illustrates a front view of a prosthesis according to another prefened embodiment of the present invention;

[0069] Figure 23B illustrates a top view of the prosthesis of Figure 23A;

[0070] Figures 23C and 23D. illustrate various perspective views of the prosthesis of Figure 20A;

[0071] Figure 24A illustrates a front view of a prosthesis according to another preferred embodiment of the present invention;

-8CA 02848445 2014-04-08

WO 2006/032051 PCT/US2005/033381

[0072] Figure 24B illustrates a side view of the prosthesis of Figure 23A;

[0073] Figures 24C and 24D illustrate various perspective views of the prosthesis of Figure 20A;

[0074] Figure 24E illustrates an enlarged view of area 24E in Figure 24D;

[0075] Figure 25 illustrates a side view of a prosthesis within a heart according to another preferred embodiment of the present invention;

[0076] Figure 26A illustrates a side view of a prosthesis within a heart according to another preferred embodiment of the present invention; and

[0077] Figure 26B illustrates a cross-sectional view of the prosthesis of Figure 26A.

DETAILED DESCRIPTION OF THE INVENTION

[0078] The present invention seeks to reduce the amount of blood that flows into the left atrium from the left ventricle during the systole phase of heart contraction. Most instances of this mitral valve regurgitation are caused by poor coaptation of the mitral valve leaflets that create openings between these leaflets when the mitral valve is closed. The present invention decreases the size of these opening between the mitral valve leaflets, and in some cases completely eliminates the openings, allowing the mitral valve to function with little or no regurgitation. This is achieved in at least some of the example embodiments described in this specification by positioning a member between the two mitral valve leaflets to close or fill up the openings between the leaflets when closed.

[0079] Figures 1A-4

[0080] One such design can be seen in Figures 1A-4 which illustrates a preferred embodiment of a prosthesis 100 according to the present invention. The prosthesis 100 includes a pocket 106 formed from flexible material 104 disposed on a ring 102. As best seen in Figure 1B, the pocket 106 includes a lower open end 106A that, when properly oriented within a mitral valve 120 of a heart 124_r expands as the mitral valve 120 closes,

-9CA 02848445 2014-04-08 blocking any openings between the mitral valve leaflets 122. Further, the pocket 106 contracts or deflates as the mitral valve 120 opens, maximizing blood flow from a left atrium 126 to a left ventricle 128. In this sense, the pocket 106 can more generally be described as an expandable occluding member or a coaptation member.

[0081] The pocket 106 is preferably created by gluing, stitching, or otherwise adhering at least two layers of the flexible material 104 at or around line 108. These layers can be achieved with two distinct pieces of material, or a single piece of material folded against itself. Preferably, the flexible material .104 Is made from pericardial tissue or other biological or artificial materials with similar flexibilities, such as bovine tissue, polyurethane, or as described in U.S. Patent No. 6,764,510. The shape of the pocket 106 and the flexibility of the flexible fabric 108 allow the pocket 106 to achieve a deflated position, as best seen in Figures 1D, 2A and 3A and an expanded position as best seen in Figures 1C, 2B and 3B.

[0082] While the pocket 106 can be shaped in a variety of different configurations, pocket shapes that facilitate entry and escape of blood from the pocket 106, such as the rounded archshape of pocket 106, are preferred. Configurations of the pocket 106 that include sharp corners or rough seams are less preferred due to their disruptive effect on blood flow into and out of the pocket 106. Preferably, the pocket 106 also includes an overall length similar to that of the mitral valve 120 and more preferably substantially the length of the mitral valve commissure, allowing the pocket 106 to fill any openings that may be present along the length of leaflets 122, as seen best in Figure 2B. While a single pocket 106 is preferred, additional pockets or partitions within the pocket can also be Included in the present invention.

[0083] The ring 102 is preferably made from an elastic, shape-memory material such as Nitinol which allows the prosthesis 100 to be compressed or loaded into a delivery catheter 110, as seen in Figure 4, then expanded to a predetermined shape within the left atrium 126, as seen in Figures 3A and 3B. The ring 102 is sized to press against the walls of the left atrium 126 of the heart 124, and in some configurations within the commissure of the mitral valve 120, thereby anchoring the position of the prosthesis 100, while positioning the

-10#10940343 Vi

CA 02848445 2014-04-08

WO 2006/032051 PCT/ÜS2005/033381 pocket 106 at least partially through a mitral valve 120. Additionally, the lower open end 106A of the pocket 106 is positioned near or within the left ventricle 128. In this sense, the ring 102 can more generally be described as an anchoring framework or an anchoring structure.

[0084] · Once positioned within the heart 124, the prosthesis 100 functions in a similar manner to a heart valve, opening during diastole and closing during systole. More specifically, as blood enters the left atrium from the pulmonary veins 125 near the top of the left atrium 126, the blood flow moves downward towards the mitral valve 120. As the blood flow reaches the mitral valve 120, it pushes against the mitral valve leaflets 122 as the mitral valve 120 is opened by the papillary muscles. The blood flow also pushes against the pocket 106 of the prosthesis 100, forcing out any blood that may be within the pocket 106 and causing the pocket 106 to assume a substantially deflated or compressed position, as seen in Figure 3A. This compressed configuration of the pocket 106 provides a streamline profile that minimizes blood flow resistance and other disruptive effects that a device within the left atrium might otherwise cause. In this respect, the blood flow during diastole passes into the left atrium 126, through the mitral valve 120 and past theprosthesis 100 to allow passage of the blood flow into the left ventricle 128.

[0085] During systole, backpressure from the blood in the left ventricle 128 presses against the mitral valve leaflets 122, as the papillary muscles move these leaflets 122 to a closed position. Additionally, this backpressure of blood in .the left ventricle 128 enters the pocket 106 of the prosthesis 100, causing the pocket 106 to achieve an expanded shape, as seen In Figure 3B. The mitral valve leaflets 124 coapt against the expanded pocket 106, as best seen in Figure 2B, minimizing or even eliminating gaps that would otherwise be present between the two leaflets 122. Thus, blood flow during systole expands the prosthesis 100 to reduce or eliminate any openings that would otherwise be present between the leaflets 122, ultimately reducing or preventing regurgitation of blood into the left atrium 126.

[0086] Due in part to the dynamic, flexible nature of the pocket 106, the prosthesis 100 can expand to fill a wide range of opening sizes between the leaflets 122 without the need -11CA 02848445 2014-04-08

WO 2006/032051 PCT/US2005/033381 for an equally wide range of pocket sizes. In other words, the same size pocket 106 can expand to fill a relatively small opening or a relatively large opening- between the mitral valve leaflets 122. Thus, the same size prosthesis 100 may be appropriate for a patient with relatively severe mitral valve regurgitation as well as relatively mild mitral valve regurgitation. Different sizes of prosthesis 100 may be appropriate, however, for different size mitral valves 120, since it is preferred that the pocket 106 extends along the length of the commissure of the mitral valve or the length of the meeting line between the two leaflets.

[0087] The prosthesis 100 is preferably delivered to the left atrium 126 percutaneously by a catheter 110, as seen in Figure 4. For example, the delivery catheter 110 may be fed through the femoral vein, into the right atrium and passed through a pre-made puncture In the atrial septum 125. In another example, the delivery catheter 110 can be passed through the femoral artery into the aorta, through the aortic valve and into the left ventricle.

[0088] Alternately, the prosthesis 100 can be inserted into the left atrium 126 through an opening in the atrial wall of the heart 125 during open-heart surgery. Although the prosthesis 100 can be seen and positioned more easily during open-heart procedures, percutaneous delivery Is less invasive and therefore includes a substantially lower risk of complications.

[0089] Figures 5A-8B

[0090] Another preferred embodiment of a prosthesis 200 according to the present invention can be seen in Figures 5A-7B. While generally similar to the prosthesis 100, the prosthesis 200 also includes four anchoring loops 202 that expand to anchor the prosthesis 200 within the left atrium 126 and position a pocket 206 between the mitral valve leaflets 122, along the length of the mitral valve commissure. In this respect, the anchoring loops 202 can more generally be described as an anchoring framework or an anchoring structure.

[0091] The pocket 206 is supported by support arms 204 and bottom support 208 which provide a support framework for the pocket 206. Preferably the side arms 204 and the

-12CA 02848445 2014-04-08 '·

WO 2006/032051

PCT/US2005/033381 bottom support 208 are a single, unitary wire that connect to the anchoring loops 202, however multiple segments of wire can be connected together, for example by welding or soldering, as well. As with the previously described embodiment of the prosthesis 100, the support arms 204 and the bottom support 208 are preferably composed of an elastic, memory-shape material, such as Nitinol, which allows the prosthesis 200 to be compressed and loaded into a catheter 110, as seen in Figures 7A and 7B, then deployed to the predetermined shape seen in Figures 5A-6. Preferably, the wires used for the support arms 204 and the bottom support 208 are sized and shaped to cause minimal deformation of the free edges of the leaflets 122, and therefore minimize distortion of the mitral valve geometry. In this respect, the pocket support arms 204 can alternatively be described as a framework, a support structure, or a positioning frame.

[0092] The pocket 206 is similar to the pocket 106 of the previous embodiment, preferably being composed of a flexible biological or artificial material that is sized and shaped to form a pocket-shape with an opening directed opposite to the anchoring loops 202. The pocket 206 can be directly stitched, glued, or adhered to the outer support arms 204 for support. Alternately, the flexible fabric of the pocket 206 can be stitched to form an elongated passage for the support arms 204 on the outer surface of the pocket 206.

[0093] As best seen in Figure 6, the pocket 206 is positioned at least partially within the mitral valve 120 so that the open end of the pocket 206 is faced toward the left ventricle 128. In this configuration, thé pocket 206 is deflated during diastole, minimizing blood flow blockage in the mitral valve 120, and expanded during systole, at least partially filling any openings between the mitral valve leaflets 122 and thereby minimizing blood flow regurgitation into the left atrium 126.

[0094] The prosthesis 200 is preferably delivered to the left atrium 126 by a percutaneous delivery catheter 110 but can also be implanted during open-heart surgery, as described in regards to the prosthesis 100. Since the pocket 206 has a horizontally elongated shape that requires a specific orientation within the mitral valve 120, percutaneous delivery of the prosthesis 200 to .the proper position may be more difficult than delivery during open-heart surgery. Accordingly, the delivery catheter 110 may -13CA 02848445 2014-04-08

WO 2006/032051 PCT7US2005/033381 include a retrieval thread 210 and a push rod 212 as seen in Figures 8A and 8b to retrieve the prosthesis 200 back into the catheter 110 and redeploy the prosthesis 200 at a new position within the left atrium 126.

[0095] Preferably, the retrieval thread 210 is composed of a thin but strong material such as metal, silk, or polypropylene, and is a single segment. Both freè ends of the retrieval thread 210 are positioned at a proximal end of the delivery catheter 110, while the body of the thread 210 extends through the deliver catheter 110, through each anchoring loop 202 and back through the catheter 110.

[0096] Depending on the configuration of the prosthesis 200 in an expanded state, the retrieval thread 210 alone may not provide the necessary force to fully recompress and recapture the prosthesis 200.. In such situations, the pusher rod 212 may be used in conjunction with the retrieval thread 210 to manipulate the prosthesis 200 into a shape acceptable for recapture within the delivery catheter 110. For example, the operator of the delivery catheter 110 may pull on the retrieval thread 210 while pushing on the anchoring loops 202 with the pusher rod 212. The simultaneous pushing and pulling deform the anchoring loops 202 into an elongated shape that can more easily be recaptured by the delivery catheter 110, allow the user to reposition the distal end of the delivery catheter 110 and redeploy the prosthesis 200.

[0097] Figures 9A-9E

[0098] Figures 9A-9E illustrate another preferred embodiment of a prosthesis 250 that is mostly similar to the prosthesis 200 previously shown in Figures 5A-8B, having anchoring loops 252 fixed to support arms 258 and a pocket 254 disposed between the support arms 256. However, as best seen in Figure 9E, the support arms 258 of the present prosthesis 250 are positioned and attached within the pocket 254 instead of on the outer surface of the pocket 254, creating a more uniform outer surface shape compared with the prosthesis 200. Additionally, the bottom support 256 includes a loop 256A that is configured to exert force against the support arms 258 to maintain the pocket 254 in a fully expanded position.

-14CA 02848445 2014-04-08

WO 2006/032051 PCT/ÜS2005/033381

[0099] Figures 10A-11

[00100] Figures 10A-11 illustrate yet another embodiment of a prosthesis 300 according to the present invention that is generally similar to the previously described embodiments of this specification, having support arms 304 that support a pocket 306 made from flexible material.

[00101] Unlike the embodiments previously déscribed in this specification, the prosthesis 300 includes an anchoring cage 302 that is unitary with the support arms 304. Preferably, both the anchoring cage 302 and the support arms 304 are cut from a single metal tube, such as by laser cutting the desired pattern into the tube or by other techniques used to manufacture stents. The metal of the tube is preferably composed a shape memory material, such as those commonly used for stents such as Nitinol. In this regard, the anchoring cage 302 can more generally be described as an anchoring framework or an anchoring structure.

[00102] Once expanded within the left atrium 126, the anchoring cage 302 contacts the tissue of the left atrium 126 in more positions that embodiments previously described in this specification and therefore more uniformly distributes the anchoring force within the left atrium 126. Additionally, the expanded shape of the anchoring cage 302 can be shaped to better conform to the geometry of the left atrium 126 and therefore more precisely position the pocket 306 at a desired location.

[00103] As with the previously described embodiments of this specification, the prosthesis 300 is preferably delivered percutaneously with a delivery catheter 110 as seenin Figure 11, but may alternately be deployed during open-heart surgery. In the case of percutaneous deployment, the prosthesis 300 compresses to a relatively small predeployed state, as seen in Figure 11.

[00104] Figures 12A-13

[00105] Figures 12A-13 illustrate another preferred embodiment of a prosthesis 400 according to the present invention, which is generally similar to the previously described -15CA 02848445 2014-04-08

WO 2006/032051 PCT/US2005/033381 embodiments, such as the prosthesis 200 shown in Figures 5A-8B. More specifically, the similarities of the prosthesis 400 include anchoring loops 402 that anchor and position a pocket 406 via support arms 404. The pocket 406 is similarly positioned within the mitral valve 120 so as to expand into any openings between the mitral valve leaflets 122 when the mitral valve 120 is closed.

[00106] In contrast to the previously described embodiments, the prosthesis 400 includes multiple anchoring loops 402 that form a spherical, lemon shape having a terminating region 408. The overall shape of the anchoring loops 402 expand to apply pressure against the left atrium 126 at different angles which better maintains the position of the prosthesis 400. Additionally, the terminating region 408 can press against the tissue of the left atrium 126 or can alternatively be positioned within an incision within the wall of the left atrium 126 (e.g. a percutaneous access incision within the atrium septum) to provide further anchoring support.

[00107] The body of the prosthesis 400 includes wires 402A-402E that are shaped to form the anchoring loops 402, as well as two pocket supports 404. Wires 402B, 402C, and 402D are shaped to have a generally circular shape with each of the free ends captured by terminating region 408. In this respect, each wire 402B, 402C, and 402D forms a single loop of the prosthesis 400.·

[00108] One end of wire 402A is fixed within terminating region 408 while the other end extends down to form a pocket support 404, including an arch-shape in between the two ends having a similar shape tô those formed by wires 402B, 402C, and 402D. The second pocket support 404 is formed from wire 404E which is· similarly fixed within terminating region 408. As with the previously described embodiments described in this specification, the pocket 406 is fixed to the pocket supports 404, thereby maintaining the pocket 406 at a desired Ideation within the mitral valve 120, as best seen in Figure 13. In this regard, the anchoring loops 402 can more generally be described as an anchoring framework or an anchoring structure.

-16CA 02848445 2014-04-08

WO 2006/032051 PCT/ÜS2005/033381

[00109] Figures 14A-16B

[00110] In another preferred embodiment illustrated in Figures 14A_:16B, a prosthesis 500 is shown according to the present invention. Similar to previous embodiments discussed within this specification, the prosthesis 500 includes a pocket 506 that is supported and positioned by an anchoring wire 502. While the present prosthesis 500 includes curved anchoring regions 502A, similar to the curved anchoring wires of previously discussed embodiments, these anchoring regions 502A are composed of a single anchoring wire 502. By using a single anchoring wire 502, the prosthesis 500 minimizes the possible sharp ends or edges that may otherwise be present. In this sense, the anchoring wire 502 can more generally be described as an anchoring framework or an anchoring structure.

[00111] Às seen in Figures 16A and 16B, one possible delivery method of the prosthesis 500 includes compressing or loading the prosthesis 500 within the percutaneous delivery catheter 110 and delivering the prosthesis 500 to the left àtrium 126. Once within the left atrium 126, the prosthesis 500 expands to the predefined shape seen in Figure 15. Thus, the prosthesis 500 maintains the position of the pocket 506 within the mitral valve 120, similar to previously discussed embodiments, reducing regurgitation.

[00112] Figures 17A-17D

[00113] Figures 17A-17D illustrate yet another preferred embodiment of a prosthesis 600 according to the present invention that reduces mitral valve regurgitation similar to the embodiments previously described in this specification by anchoring a pocket 606 within the mitral valve 120.

[00114] In contrast, present prosthesis 600 includes anchoring wires 602 shaped to have an asymmetrical egg structure that more closely resembles the asymmetrical interior of the left atrium 126. Since the asymmetry of the anchoring wires 602 matches the natural asymmetry of the left atrium 126, the prosthesis 600 expands and orients itself in a predetermined position, providing stable anchoring and consistent alignment of the pocket 606 with'the mitral valve 120. Further, this asymmetrical design facilitates delivery and

-17CA 02848445 2014-04-08

WO 2006/032051 PC17US2005/033381 deployment from the position of an incisio.n through the atrial septum, since the prosthesis 600 expands to firmly engage the geometry of the left atrium 126. In this regard, the anchoring wires 602 can more generally be described as an anchoring framework or an anchoring structure.

[00115] The pocket 606 also includes a radial or cylinder shape when fully expanded; and can more generally be described as an expandable occluding member or a coaptation member. The radial shape imparts a uniform hydraulic function that is similar, regardless of the rotationally orientation of the pocket 606 relative to the mitral valve leaflets 122 (i.e. the commissure of the mitral valve 120). In this respect, the prosthesis 600 can be deployed to a greater number of orientations without adversely affecting the reduction of regurgitation.

[00116] Figures 18A-18D

[00117] Figures 18A-18D show another preferred embodiment of a prosthesis 700 according to the present invention that is much like the previously described prosthesis 600, having anchoring wires 702 forming an asymmetrical shape similar to the geometry of the left atrium 126. However, the present prosthesis 700 includes a pocket 706 with an elongated, non-radial shape that is coupled to the anchoring wires 702 by a rotating swivel 710. The swivel 710 allows rotation between the pocket 706 and the anchoring wires 702, allowing the pocket 706 to achieve a desired rotational orientation within the mitral valve 12Q, regardless of the orientation of the anchoring wires 702. In this respect, the anchoring wires 702 can more generally be described as an anchoring framework or an anchoring structure.

[00118] As best seen in Figure 18D, the swivel 710 is composed of wire loop 708 that extends from an unseen wire support of the pocket 706. The anchoring wires 702 include.a wire coil 704 that encircles and thereby engages the wire loop 708, allowing the anchoring wires 702 to rotate in relation to the pocket 706. in this respect, the surgeon can more easily deploy the prosthesis 700 percutaneously by first positioning the pocket 706 at a desired position within the mitral valve 120, then deploying the anchoring wires 702 without the need to adjust the overall rotational orientation of the prosthesis 700. Additionally, the

-18CA 02848445 2014-04-08

WO 2006/032051 PCT/ÜS2005/033381 ability of the prosthesis 700 to rotate allows the pocket 706 to self align so that each mitral valve leaflet 122 contacts against an elongated side of the pocket 706.

[00119] Figures 19A-19D

[00120] Figures 19A-19D illustrate a preferred embodiment of a prosthesis 800 that is similar to the embodiments previously described In this specification, especially the prosthesis 700 shown in Figures 18A-18D. More specifically, the prosthesis 800 includes anchoring wires 802 which expand to an asymmetrical shape, similar to the geometry of the left atrium 126. Additionally, the prosthesis 800 includes an elongated pocket 806 coupled to the anchoring wires 802 by a rotating joint 810. In this regard, the anchoring wires 802 can more generally be described as an anchoring framework or an anchoring structure.

[00121] In contrast to the previously described prosthesis 700, the prosthesis 800 includes a pocket support wire 804 that not only supports the structure of the pocket 806, as described in other embodiments in this specification, but also wraps around a cylinder 808, then branches radially outward into loop shapes 804A, as best seen in Figure 19D. The ends of anchoring wires 802 are coupled within the cylinder 808 so as to allow the anchoring wires 806 rotate freely from the pocket 806.

[00122] The looped regions 804A of the pocket support wire 804 assist the freely rotating pocket 806 in orienting itself to a desired position within the mitral valve 120. Additionally, these outer looped regions 804A can be sized and shaped to provide support to the pocket 806 by resting on the annulus of the mitral valve 120.

[00123] Alternately, the looped regions of the pocket support wire 804 can be shaped to at least partially interlock with a portion of the anchoring wires 802 to allow the anchoring wires 802 to freely rotate within a range, determined and therefore restricted by the length of the loops of the pocket support wire 804. Such a rotational restriction may better assist the surgeon in delivering and deploying by allowing at least some degree of rotational control over the pocket 806 in a deployed configuration.

-19CA 02848445 2014-04-08

WO 2006/032051 PCT/US2005/033381

[00124] Figures 20A-21B

[00125] Figures 20A-21B illustrate yet another preferred embodiment of a prosthesis 900 according to the present invention which is generally similar to the previously discussed embodiments of this specification, such as prosthesis 600 of Figures 17A-17D. For example, the prosthesis 900 includes a pocket 906 having a radial shape and pocket support wires 908, as well as anchoring wires 902 fixed to the pocket 906 and having an asymmetrical shape generally matching the inner geometry of the left atrium 126.

[00126] However, the prosthesis 900 includes two separately deployable support structures: the previously mentioned anchoring wires 902 and inner support wires 904. The inner'support wires 904 include elongated region 904A and anchoring region 9Û4B which continues within the pocket 906 as support wires 908. The anchoring wires 902 and inner support wires 904 can more generally be described as an an anchoring framework or an anchoring structure.

[00127] As best seen in Figures 21A and 21B, the support structures 902 and 904 can be deployed separately during a percutaneous deliver with the deliver catheter .110. As the prosthesis 900 is pushed out of the delivery catheter 110, the inner support wire 904, including elongated region 904A and anchoring region 904B, expand first while the anchoring wires 902 remain relatively compressed.

[00128] The expanded shape of the anchoring region 904B is preferably sized and shaped to engage at least a portion of the annulus of the mitral valve 120.- In this respect, the user can direct the pocket 906 to a desired position within the mitral valve 120 while the anchoring region 904B expands to at least partially anchor the pocket 906 in place. Once the user has achieved a desired position for the pocket 906, the remaining anchoring wires 902 can be deployed from the delivery catheter 110, allowing them to expand to press against the left ventricle 126, thereby further anchoring the prosthesis 900 in place.

-20CA 02848445 2014-04-08

WO 2006/032051 PCT/US2005/033381

[00129] Figures 22A-22C

[00130] Figures 22A-22C illustrate yet another preferred embodiment of a prosthesis 1000 according to the present invention. Generally, this prosthesis 1000 is similar to the embodiments previously described in this specification, such as prosthesis 600 of Figures 17A-17D, including anchoring wires 1002, pocket support wires 1004, and pocket 10006 having a radial shape.

[00131] In addition to these similarities, the prosthesis 1000 includes region 1002A of anchoring wires 1002 that curve towards the open end of the pocket 1006. When expanded within the left atrium 126, the region 1002A of the present invention at least partially contacts the annulus of the mitral valve 120. This annulus support prevents the pocket 1006 from being pushed past the mitral valve 120 into the left ventricle 128, maintaining the overall vertical position of the prosthesis within the left atrium 120. In this respect, the anchoring wires 1002 can more generally be described as an anchoring framework or an anchoring structure.

[00132] Figures 23A-23D

[00133] Turning now to Figures 23A-23D, yet another preferred embodiment of a prosthesis 1100 according to the present invention is shown. Again, this prosthesis is generally similar to the previous embodiments described in this specification, including a pocket 1106 having an elongated shape, anchoring wires 1102, and lower loops 1104 that partially support the pocket 1106 and extent out from a top portion of the pocket 1106.

[00134] However, the free ends of the anchoring wires 1102 are wound around lower loops 1104, allowing the loops of anchoring wire 1102 to pivot on the lower loops 1104 to achieve more complex anchoring configurations. By achieve more complex anchoring configurations, the prosthesis 1100 can provide better support and therefore more constant positioning of the pocket 1106 over time. In this regard, the anchoring wires 1102 can more generally be described as an anchoring framework or an anchoring structure.

-21 CA 02848445 2014-04-08

[00135] Figures 24A-24E

[00136] Figures 24A-24E illustrate another preferred embodiment of a prosthesis 1200 according to the present invention, having a pocket 1206 with an elongated shape, a pivot loop 1204 that is part of an unseen pocket support wire within the pocket 1206, and an anchoring wire 1202 having a region 1210 wound around the pivot loop 1204 to form a freely rotating pivot 1212.

[00137] To achieve additional complexity with the design of the anchoring wire 1202, portions of the anchoring wire fixed to each other with knitting 1208, as best seen in Figure 24E. By achieving additional complexity and looping structures, the prosthesis 1200 may be better able to anchor and therefore secure itself within the left atrium 126. Further, the knitting 1208 allows the bound regions of the anchoring wire 1202 to hinge relative to each other, which can allow more efficient packing within a delivery catheter 110 or more complex deployment strategies within the left ventricle 126. In this respect, the anchoring wire 1202 can more generally be described as an anchoring framework or an anchoring structure.

[00138] Figure 25

[00139] Turning to Figure 25, yet another preferred embodiment of a prosthesis 1300 is illustrated according to the present invention. Specifically, prosthesis 1300 demonstrates a pocket 1306 having pocket supports 1304, generally similar to the embodiments previously described in this specification, and further including a stent anchor 1302 coupled to the pocket supports 1304. In this respect, the stent anchor 1302 can more generally be described as an anchoring framework or an anchoring structure.

[00140] The stent anchor 1302 can be composed of a variety of different materials and structures as is known in the art. For example, some stent techniques can be seen in U.S. Patent No. 6,936,067; 6,929,658; 6,926,743; 6,923,828;, and 6,902,575.

-22#10940343 v1

CA 02848445 2014-04-08

WO 2006/032051 PCT/ÜS2005/033381

[00141] Figures 26A-26B

[00142] Turning to Figures 26A and 26B, yet another preferred embodiment of a prosthesis 1400 is illustrated according to the present invention, which includes an alternative anchoring and positioning system for a pocket 1406. Specifically, a positioning arm 1402 anchors within the atrial septum 125, having multiple septum attachment arms 1402 that extend from the base of the positioning arm 1402 and press against both the right and left sides of the atrial septum 125. Preferably, the septum attachment arms 1402 are similar in size and shape to those in atrial septal closure devices known in the art. To this end, the positioning arm 1402 can more generally be described as an anchoring framework or an anchoring structure.

[00143] In this respect, the prosthesis 1400 can be delivered via an incision in the atrial septum 125, first positioning the pocket 1406 within the mitral valve 120, then extending the septum attachment arms 1404 against both the left and right sides of the atrial septum 125 for anchoring support. The positioning arm 1402 substantially occludes the incision within the atrial septum 125, while the septum attachment arms 1402 retain the septal tissue around the positioning arm 1402, preventing blood from passing between through the septum 125.

[00144] While the preferred embodiments disclosed in this specification include expandable pockets, it should be understood that other designs can be used with the anchoring designs contemplated by the present invention. For example, a solid and preferably flexible plate member can alternatively be used, having a similar shape and size as described in regards to the pockets of the embodiments of this specification.

[00145] Preferably, the solid member is relatively soft, having, a flexibility that allows some compression, especially when contacted by mitral valve leaflets. More preferably, the solid member could be’ created by adhering two pieces of pericardial tissue together and providing supporting members or wires similar to those described in regards to the pocket in the previous embodiments. In place of supporting members, Nitinol string may be attached to both the· solid member and the left ventricle 128, preventing the solid member

-23CA 02848445 2014-04-08 from moving into the left atrium 126. Alternatively, the solid member can be composed of a resilient, biocompatible polymer material such as polyurethane.

[00146] Preferably, the embodiments of this specification may also include flexible polymeric sheets, such as polyurethane, that connect the anchoring loops or anchoring wire that contact the left atrium 126. In this respect, the flexible sheets further decreases stress on the left atrium walls by more evenly distributing anchoring force.

[00147] It should be understood different elements of the embodiments of this application can be combine to form additional design contemplated by the present invention: For example, the septal anchoring prosthesis 1400 shown in Figures 26A and 26B may be combine with the anchoring structures shown with the prosthesis 900 of Figures 20A-20C.

[00148] While the embodiments disclosed in the present invention have been specifically described as used with the mitral valve of the heart, it is also contemplated that these embodiments may be adapted for use with other heart valves. For example, the anchoring structures can be modified to press against a different geometry within the heart and the pocket can be adapted to a different shaped valve, such as a tricuspid valve.

[00149]

-24#10940343 vl