Heart valve sealing device and delivery device thereof

Abstract

To provide improved devices and methods for treating mitral valve regurgitation.SOLUTION: In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion, where the prosthetic device is movable between a compressed configuration, in which the spacer body portion is radially compressed and is axially spaced relative to the anchor portion, and an expanded configuration, in which the spacer body portion expands radially outwardly relative to the compressed configuration and overlaps at least a portion of the anchor portion.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates generally to prosthetic devices and associated methods for sealing native heart valves and helping to prevent or reduce regurgitation through the native heart valves, and devices and associated methods for implanting such prosthetic devices. [Background technology]

[0002] Native prosthetic valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) perform a vital function in ensuring adequate forward blood flow in the cardiovascular system. These heart valves can be damaged and therefore less effective due to congenital malformations, inflammatory processes, infections, or diseases. Such damage to the valves can result in serious cardiovascular compromise or death. For many years, the most definitive treatment for such damaged valves has been surgical repair or replacement of the valve during open-heart surgery. However, such open-heart surgery is highly invasive and prone to numerous complications. Thus, frail middle-aged and elderly patients with defective heart valves have often been left untreated. More recently, transvascular techniques have been developed to introduce and implant prosthetic devices in a manner that is much less invasive than open-heart surgery. One particular transvascular technique utilized to access the native mitral and aortic valves is the transseptal technique. The transseptal technique involves inserting a catheter into the right femoral vein, through the inferior vena cava, and into the right atrium. The septum is then punctured and the catheter is advanced into the left atrium. Such transvascular techniques have become popular due to their high success rate.

[0003] A healthy heart has an approximately conical shape tapering toward the inferior cusp. The heart is made up of four chambers, including the left atrium, the right atrium, the left ventricle, and the right ventricle. The left and right sides of the heart are separated by a wall commonly referred to as the septum. The native mitral valve of the human heart connects the left atrium to the left ventricle. The mitral valve has a very different anatomical structure than other native heart valves. The mitral valve includes an annular portion of native valve tissue that surrounds the mitral valve opening, the annulus portion, and a pair of leaflets that extend downward from the annulus into the left ventricle. The mitral annulus may form a "D"-shaped, elliptical, or other non-circular cross-sectional shape with major and minor axes. The anterior leaflet is larger than the posterior leaflet, which may form an approximately "C"-shaped boundary between the abutting free edges of the leaflets when they are closed together.

[0004] When operating properly, the anterior and posterior leaflets function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygen-rich blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygen-rich blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricle muscle contracts (also called "ventricular systole" or "systole"), the rising blood pressure in the left ventricle urges the two leaflets together to close the one-way mitral valve, preventing blood from flowing back into the left atrium and instead forcing it out of the left ventricle through the aortic valve. To prevent the leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles in the left ventricle.

[0005] Mitral regurgitation occurs when the native mitral valve fails to close properly and blood flows from the left ventricle into the left atrium during cardiac systole. Mitral regurgitation is the most common form of valvular heart disease. Mitral regurgitation has various causes, including leaflet prolapse, dysfunctional papillary muscles, and / or stretching of the mitral annulus as a result of left ventricular dilation. Mitral regurgitation in the central portion of the leaflets may be referred to as central jet mitral regurgitation, whereas mitral regurgitation closer to the leaflets' commissures (i.e., where the leaflets meet) may be referred to as eccentric jet mitral regurgitation. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Pat. No. 8,449,599 [Patent Document 2] US Patent Application Publication No. 2014 / 0222136 [Patent Document 3] US Patent Application Publication No. 2014 / 0067052 [Patent Document 4] US Patent Application Publication No. 2015 / 0336150 Summary of the Invention [Problem to be solved by the invention]

[0007] Some prior art techniques for treating mitral valve regurgitation include directly sewing portions of the native mitral valve leaflets together. Other prior art techniques include the use of spacers that are implanted between the native mitral valve leaflets. Despite these prior art techniques, there continues to be a need for improved devices and methods for treating mitral valve regurgitation. [Means for solving the problem]

[0008] Described herein are embodiments of prosthetic devices primarily intended for implantation in one of the mitral, aortic, tricuspid, or pulmonary valve regions of the human heart, and apparatus and methods for implanting the prosthetic devices. The prosthetic devices can be used to help repair and / or replace the function of a defective native mitral valve.

[0009] In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between the native valve leaflets of a heart and an anchor portion configured to secure the native valve leaflets relative to the spacer body portion, the prosthetic device being movable between a compressed configuration in which the spacer body portion is radially compressed and axially spaced apart from the anchor portion, and an expanded configuration in which the spacer body portion expands radially outward relative to the compressed configuration and overlaps at least a portion of the anchor portion.

[0010] In some embodiments, the anchor portion comprises a plurality of anchor members each configured to secure a respective native valve leaflet relative to the spacer body portion. In some of these embodiments, each anchor member has a first portion, a second portion, and a junction portion disposed between the first portion and the second portion, the first portion being spaced apart relative to the second portion in the compressed configuration and overlapping the second portion in the expanded configuration.

[0011] In some embodiments, the prosthetic device further comprises an end member axially spaced from and movable relative to the spacer body portion, a first portion of the anchor member pivotally coupled to the end portion of the spacer body portion and a second portion of the anchor member pivotally coupled to the end member, the anchor member configured to bendable at the junction when the spacer body portion is moved relative to the end member. In some embodiments, the anchor member is configured to fold at the junction from a compressed configuration to an expanded configuration when the spacer body portion is moved relatively closer to the end member, and the anchor member is configured to unfold at the junction from the expanded configuration to the compressed configuration when the spacer body portion is moved relatively farther from the end member.

[0012] In some embodiments, the prosthetic device further comprises a fixation member having a barb coupled to one of the anchor members, the fixation member configured to engage the native leaflet tissue and secure the native leaflet tissue to one of the anchor members. In some of these embodiments, the fixation member is pivotally coupled to the spacer body portion and the anchor portion.

[0013] In some embodiments, the anchor members are movable relative to one another. In some embodiments, the spacer body portion and the anchor portion are formed from a single, unitary piece of braided material. In some embodiments, the braided material comprises Nitinol. In some embodiments, the spacer body portion and the anchor portion are self-expanding. In some embodiments, the prosthetic device is configured for implantation within a native mitral valve and to reduce mitral regurgitation.

[0014] In another representative embodiment, an assembly is provided that includes an implantable prosthetic device having a spacer body and a plurality of anchors, where a first end portion of the anchor is coupled to the first end portion of the spacer body, and a delivery apparatus having a first shaft and a second shaft, where the first shaft and the second shaft are movable relative to each other. The second end portion of the anchor is removably coupled to the first shaft, and the second end portion of the spacer body is removably coupled to the second shaft. The delivery apparatus is configured to move the first shaft and the second shaft toward each other to move the prosthetic device between a first configuration in which the spacer body is radially compressed and axially spaced apart from the anchors, and a second configuration in which the spacer body expands radially outward relative to the compressed configuration, and the anchors at least partially overlap the spacer body to capture the native valve leaflets between the anchors and the spacer body.

[0015] In some embodiments, the first shaft of the delivery apparatus extends through the second shaft of the delivery apparatus and the spacer body of the prosthetic device, the first shaft being axially movable relative to the spacer body. In some embodiments, the first shaft of the delivery apparatus is a plurality of anchor shafts, each of which is removably coupled to a respective anchor of the prosthetic device and movable relative to others of the anchor shafts.

[0016] In some embodiments, each of the anchors has a first portion, a second portion, and a joint portion disposed between the first portion and the second portion, the first portion being spaced apart from the second portion in the first configuration and overlapping the second portion in the second configuration. In some embodiments, the prosthetic device further comprises an end member spaced apart from the spacer body and movable relative to the spacer body, the first portion of the anchor pivotally coupled to the end portion of the spacer body, and the second portion of the anchor pivotally coupled to the end member, the anchor bending at the joint portion when the spacer body is moved relative to the end member. In some embodiments, the anchor bending at the joint portion from a compressed configuration to an expanded configuration when the spacer body is moved relatively closer to the end member, and the anchor unfolding at the joint portion from an expanded configuration to a compressed configuration when the spacer body portion is moved relatively farther from the end member.

[0017] In some embodiments, the prosthetic device further comprises a fixation member having a barb coupled to the anchor and configured to engage the native leaflet tissue to secure the anchor to the native leaflet.

[0018] In another representative embodiment, a method of implanting a prosthetic device is provided, the method including: advancing a prosthetic device in a compressed configuration to an implantation location using a delivery device, the prosthetic device comprising a spacer body, a first anchor, and a second anchor; radially expanding the prosthetic device from the compressed configuration to an expanded configuration; capturing a first native leaflet between two surfaces of the first anchor; capturing a second native leaflet between two surfaces of the second anchor; fixing the first native leaflet and the second native leaflet relative to the spacer body of the prosthetic device; and removing the prosthetic device from the delivery device.

[0019] In some embodiments, the act of capturing the first native leaflet occurs before the act of capturing the second native leaflet, and the act of capturing the second native leaflet occurs before the act of fixing the first and second native leaflets relative to the spacer body of the prosthetic device. In some embodiments, the act of capturing the first native leaflet occurs by actuating a first member of the delivery device, and the act of capturing the second native leaflet occurs by actuating a second member of the delivery device. In some embodiments, the first and second native leaflets are fixed relative to the spacer body of the prosthetic device by moving a first shaft of the delivery device relative to a second shaft of the delivery device.

[0020] The foregoing and other objects, features and advantages of the present invention will become more apparent from the following detailed description which proceeds with reference to the accompanying drawings. [Brief description of the drawings]

[0021] [Figure 1] 1A-1D show an implantable prosthetic device according to one embodiment at different stages of deployment. [Diagram 2] 1A-1D show an implantable prosthetic device according to one embodiment at different stages of deployment. [Diagram 3] 1A-1D show an implantable prosthetic device according to one embodiment at different stages of deployment. [Figure 4] 13A-13D show an implantable prosthetic device according to another embodiment at different stages of deployment. [Diagram 5] 13A-13D show an implantable prosthetic device according to another embodiment at different stages of deployment. [Figure 6] 1A-1D illustrate an implantable prosthetic device being delivered and implanted into a native mitral valve according to one embodiment. [Figure 7] 1A-1D illustrate an implantable prosthetic device being delivered and implanted into a native mitral valve according to one embodiment. [Figure 8]1A-1D illustrate an implantable prosthetic device being delivered and implanted into a native mitral valve according to one embodiment. [Figure 9] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 10] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 11] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 12] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 13] FIG. 13 illustrates the prosthetic device of FIGS. 9-12 being delivered and implanted into the native mitral valve. [Figure 14] FIG. 13 illustrates the prosthetic device of FIGS. 9-12 being delivered and implanted into the native mitral valve. [Figure 15] FIG. 13 illustrates the prosthetic device of FIGS. 9-12 being delivered and implanted into the native mitral valve. [Figure 16] FIG. 13 illustrates the prosthetic device of FIGS. 9-12 being delivered and implanted into the native mitral valve. [Figure 17] FIG. 13 illustrates the prosthetic device of FIGS. 9-12 being delivered and implanted into the native mitral valve. [Figure 18] FIG. 2 is a side view of another embodiment of an implantable prosthetic device. [Figure 19a] FIG. 19 illustrates an exemplary thermoforming process that may be used to form prosthetic devices such as those shown in FIGS. 9-12 or 18. [Figure 19b] FIG. 19 illustrates an exemplary thermoforming process that may be used to form prosthetic devices such as those shown in FIGS. 9-12 or 18. [Figure 19c] FIG. 19 illustrates an exemplary thermoforming process that may be used to form prosthetic devices such as those shown in FIGS. 9-12 or 18. [Figure 19d] FIG. 19 illustrates an exemplary thermoforming process that may be used to form prosthetic devices such as those shown in FIGS. 9-12 or 18. [Figure 19e] FIG. 19 illustrates an exemplary thermoforming process that may be used to form prosthetic devices such as those shown in FIGS. 9-12 or 18. [Figure 19f] FIG. 19 illustrates an exemplary thermoforming process that may be used to form prosthetic devices such as those shown in FIGS. 9-12 or 18. [Figure 19g] FIG. 19 illustrates an exemplary thermoforming process that may be used to form prosthetic devices such as those shown in FIGS. 9-12 or 18. [Figure 19h] FIG. 19 illustrates an exemplary thermoforming process that may be used to form prosthetic devices such as those shown in FIGS. 9-12 or 18. [Figure 20] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 21a] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 21b] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 22] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Diagram 23] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 24] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Diagram 25] FIG. 2 is a side view of another embodiment of an implantable prosthetic device. [Figure 26] FIG. 2 is a side view of another embodiment of an implantable prosthetic device. [Figure 27] 27A-27D show the prosthetic device of FIGS. 25-26 at different stages of deployment. [Figure 28] 27A-27D show the prosthetic device of FIGS. 25-26 at different stages of deployment. [Figure 29] 27A-27D show the prosthetic device of FIGS. 25-26 at different stages of deployment. [Diagram 30] 27A-27D show the prosthetic device of FIGS. 25-26 at different stages of deployment. [Diagram 31]27A-27D show the prosthetic device of FIGS. 25-26 at different stages of deployment. [Diagram 32] 27A-27D show the prosthetic device of FIGS. 25-26 at different stages of deployment. [Diagram 33] 27A-27D show the prosthetic device of FIGS. 25-26 at different stages of deployment. [Diagram 34] 27A-27D show the prosthetic device of FIGS. 25-26 at different stages of deployment. [Diagram 35] 1A-1C show another embodiment of an implantable prosthetic device being implanted within a native mitral valve. [Diagram 36] 1A-1C show another embodiment of an implantable prosthetic device being implanted within a native mitral valve. [Figure 37] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 38] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 39] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Diagram 40] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Diagram 41] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Diagram 42] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Diagram 43] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Diagram 44] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Diagram 45] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 46] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 47] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 48] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 49]FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 50] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 51] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 52] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 53] FIG. 1 illustrates another embodiment of an implantable prosthetic device. [Figure 54] 54A-54D show the prosthetic device of FIG. 53 at different stages of deployment within a native mitral valve. [Figure 55] 54A-54D show the prosthetic device of FIG. 53 at different stages of deployment within a native mitral valve. [Figure 56] 54A-54D show the prosthetic device of FIG. 53 at different stages of deployment within a native mitral valve. [Figure 57] 54A-54D show the prosthetic device of FIG. 53 at different stages of deployment within a native mitral valve. [Figure 58] 54A-54D show the prosthetic device of FIG. 53 at different stages of deployment within a native mitral valve. [Figure 59] 1A-1C show another embodiment of an implantable prosthetic device at different stages of deployment. [Figure 60] 1A-1C show another embodiment of an implantable prosthetic device at different stages of deployment. [Figure 61] 1A-1C show another embodiment of an implantable prosthetic device at different stages of deployment. [Figure 62] FIG. 1 is a side view of a steerable delivery device for an implantable prosthetic device, according to one embodiment. [Figure 63] 63A and 63B are end and side views of the expandable basket portion of the delivery device of FIG. 62. [Figure 64] FIG. 63C is a side view of the basket portion of FIGS. 63a and 63b shown in an expanded configuration. [Figure 65]63A and 63B are end and side views of the midshaft of the delivery device of FIG. 62 . [Figure 66] FIG. 63 is a cross-sectional view of the proximal shaft of the delivery device of FIG. [Figure 67] 63A-63C illustrate delivery of a prosthetic device to a native mitral valve using the delivery device of FIG. 62. [Figure 68] FIG. 13 is a side view of a steerable delivery device for an implantable prosthetic device according to another embodiment. [Figure 69] FIG. 69 is an exploded perspective view of the delivery device of FIG. [Figure 70a] FIG. 69 illustrates a slotted metal tube that may be incorporated into the inner steerable shaft of the delivery device of FIG. 68. [Figure 70b] FIG. 69 illustrates a slotted metal tube that may be incorporated into the inner steerable shaft of the delivery device of FIG. 68. [Figure 71a] FIG. 69 illustrates a slotted metal tube that may be incorporated into the inner steerable shaft of the delivery device of FIG. 68. [Fig. 71b] FIG. 69 illustrates a slotted metal tube that may be incorporated into the inner steerable shaft of the delivery device of FIG. 68. [Figure 72] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 73] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 74] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 75] 13A-13C are cross-sectional views of another embodiment of a steering control member that may be incorporated into a delivery device. [Figure 76] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 77] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 78]13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 79] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 80] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 81] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 82] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 83] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 84] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 85] 13A-13C show alternative embodiments of steering control members that may be incorporated into the delivery device. [Figure 86] FIG. 13 is an end view of a catheter position locking device according to one embodiment. [Figure 87] FIG. 1 is a side view of a catheter position locking device according to one embodiment. [Figure 88] 13A-13C show another embodiment of a catheter position locking device. [Figure 89] 13A-13C show another embodiment of a catheter position locking device. [Figure 90] 13A-13C show another embodiment of a catheter position locking device. [Figure 91] 13A-13C show another embodiment of a catheter position locking device. [Figure 92] 13A-13C show another embodiment of a catheter position locking device. [Figure 93] 13A-13C show another embodiment of a catheter position locking device. [Figure 94] 13A-13C show another embodiment of a catheter position locking device. [Figure 95]13A-13C show another embodiment of a catheter position locking device. [Figure 96] 13A-13C show another embodiment of a catheter position locking device. [Figure 97] FIG. 13 is a perspective view of another embodiment of a catheter position locking device. [Figure 98] FIG. 13 is an end view of another embodiment of a catheter position locking device. [Figure 99] 13A-13C show another embodiment of a delivery device being used to deliver a prosthetic device into a native mitral valve. [Figure 100] 13A-13C show another embodiment of a delivery device being used to deliver a prosthetic device into a native mitral valve. [Figure 101] 13A-13C show another embodiment of a delivery device being used to deliver a prosthetic device into a native mitral valve. [Figure 102] 13A-13C show another embodiment of a delivery device being used to deliver a prosthetic device into a native mitral valve. [Figure 103] FIG. 103 is a perspective view of an exemplary collet / prosthetic device retention mechanism that may be incorporated into the delivery device of FIGS. 99-102. [Figure 104] FIG. 1 illustrates a prosthetic device being coupled to a delivery device for delivery into a patient. [Figure 105] FIG. 1 illustrates a prosthetic device being coupled to a delivery device for delivery into a patient. [Fig. 106] FIG. 1 illustrates a prosthetic device being coupled to a delivery device for delivery into a patient. [Figure 107] 13A-13C show another embodiment of a delivery device being used to deliver a prosthetic device into a native mitral valve. [Figure 108] 13A-13C show another embodiment of a delivery device being used to deliver a prosthetic device into a native mitral valve. [Fig. 109] 13A-13C show another embodiment of a delivery device being used to deliver a prosthetic device into a native mitral valve. [Figure 110] 13A-13C show another embodiment of a delivery device being used to deliver a prosthetic device into a native mitral valve. [Figure 111] FIG. 111 is a perspective view of an exemplary collet / prosthetic device retention mechanism that may be incorporated into the delivery device of FIGS. 107-110. [Figure 112] 1A-1C are cross-sectional views of exemplary embodiments of non-circular shafts of delivery devices. [Figure 113] 13A is a cross-sectional view of another exemplary embodiment of a non-circular shaft of a delivery device. [Fig. 114] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 115] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 116] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 117] 1A-1C show exemplary embodiments of anchors that may be incorporated into an implantable prosthetic device. [Fig. 118] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 119A] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 119B] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Figure 119C] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 119D] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 119E] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 119F] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 120A] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 120B] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 120C] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 121A] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 121B] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 121C] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 121D] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 122A] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 122B] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 122C] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 122D] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 123A] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 123B] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Figure 123C] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 123D] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 124A] 123A-123D at different stages of deployment. [Fig. 124B] 123A-123D at different stages of deployment. [Fig. 124C] 123A-123D at different stages of deployment. [Fig. 124D] 123A-123D at different stages of deployment. [Fig. 124E]123A-123D at different stages of deployment. [Fig. 124F] 123A-123D at different stages of deployment. [Fig. 125A] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 125B] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 125C] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 125D] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 125E] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 126A-B] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Figure 126C] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 126D] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Figure 126E] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 126F] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Figure 126G] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 126H] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 126I] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 126J] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 127A] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 127B] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 127C] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 127D] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Figure 127E] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 127F] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Figure 128] 13A-13C show alternative embodiments of steering control mechanisms for a delivery device. [Figure 129] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 130] 1 illustrates another exemplary embodiment of an implantable prosthetic device. [Fig. 131] 1 illustrates an exemplary embodiment of an implantable prosthetic heart valve. [Fig. 132] 1 illustrates an exemplary embodiment of an implantable prosthetic heart valve. [Fig. 133] 1 illustrates an exemplary embodiment of an implantable prosthetic heart valve. [Fig. 134] 1A-1D illustrate an exemplary embodiment of a frame for an implantable prosthetic heart valve. [Fig. 135] 1A-1D illustrate an exemplary embodiment of a frame for an implantable prosthetic heart valve. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Described herein are embodiments of prosthetic devices primarily intended to be implanted in one of the mitral, aortic, tricuspid, or pulmonary valve regions of the human heart, and apparatus and methods for implanting the prosthetic devices. The prosthetic devices can be used to help repair and / or replace the function of defective native mitral valves. The disclosed embodiments should not be construed as limiting in any respect. Rather, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with each other.

[0023] Artificial spacer The artificial spacer device includes a spacer body and at least one anchor. The body is configured to be positioned in the native mitral valve opening to provide a more effective seal between the native leaflets to help prevent or minimize mitral regurgitation. The body is blood impermeable and may include a structure that may cause the native leaflets to close around the sides of the body during ventricular systole to prevent blood from flowing back from the left ventricle into the left atrium. In this specification, the body is sometimes referred to as a spacer because the body may fill the space between the native mitral valve leaflets that do not naturally close completely and cannot function properly.

[0024] The body can have a variety of shapes. In some embodiments, the body has an elongated cylindrical shape with a round cross-sectional shape. In other embodiments, the body can have an elliptical cross-sectional shape, a crescent cross-sectional shape, or a variety of other non-cylindrical shapes. The body can have an atrial or superior end positioned within or adjacent to the left atrium, a ventricular or inferior end positioned within or adjacent to the left ventricle, and annular side surfaces extending between the native mitral valve leaflets.

[0025] The anchor may be configured to secure the device to one or both of the native mitral valve leaflets such that the body is positioned between the two native leaflets. In some embodiments, the anchor may be attached to the body at a location adjacent the ventricular end of the body. In some embodiments, the anchor may be attached to a shaft, and the body may also be attached to the shaft. In some embodiments, the anchor and body may be independently positioned relative to one another by moving the anchor and body separately along the longitudinal axis of the shaft. In some embodiments, the anchor and body may be simultaneously positioned by moving the anchor and body together along the longitudinal axis of the shaft. The anchor may be configured to be positioned behind the native leaflets when implanted such that the leaflets are captured between the anchor and the body.

[0026] The prosthetic device may be configured to be implanted via a delivery sheath. The body and anchor may be compressible to a radially compressed state and self-expandable to a radially expanded state when the compressive pressure is released. The device may be configured to allow the anchor to self-expand radially away from the body, which is initially still in a compressed state, to form a gap between the body and the anchor. The native leaflets may then be positioned within the gap. The body may then be allowed to self-expand radially, thereby closing the gap between the body and the anchor and capturing the leaflets between the body and the anchor. The implantation methods for the various embodiments may vary and are discussed more fully below with respect to each embodiment. Further information regarding these and other delivery methods may be found in U.S. Patent Nos. 5,399,433, 5,499,443, 5,543,525, and 5,543,525.

[0027] Some embodiments disclosed herein are generally configured to be secured to both the anterior and posterior native mitral leaflets. However, other embodiments may include only one anchor and be configured to be secured to one of the mitral leaflets. Unless otherwise stated, any of the embodiments disclosed herein that include a single anchor may be secured to the anterior mitral leaflet or the posterior mitral leaflet, as appropriate, regardless of whether a particular embodiment is shown to be secured to a particular one of the leaflets.

[0028] Some of the prosthetic devices of the present disclosure are prevented from atrial embolism by hooking anchors around the leaflets, utilizing tension in the natural chordae tendineae to resist high systolic pressures that urge the device toward the left atrium. During diastole, the device may resist embolism into the left ventricle by relying on compressive forces applied to the leaflets captured between the body and anchors.

[0029] 1-3 show an implantable prosthetic device 10 according to one embodiment. In the illustrated embodiment, the prosthetic device 10 comprises a ventricular portion 12, a spacer body 14, and an inner shaft 16 to which the ventricular portion 12 and the spacer body 14 are attached. The ventricular portion 12 comprises a collar 18 disposed on the shaft 16 and one or more (two in the illustrated embodiment) ventricular anchors 20 extending from the collar 18. An end cap 22 may be attached to the distal end of the shaft 16 to retain the ventricular portion 12 on the shaft.

[0030] The proximal end of the spacer body 14 is secured to a collar or nut 24 that is disposed on the shaft 16 proximal to the spacer body 14. The shaft 16 thus extends coaxially through the collar 24, the spacer body 14, and the collar 18 of the ventricular portion 12. The device 10 may further include an outer shaft or sleeve 26 that extends coaxially over a proximal end portion of the inner shaft 16 and is attached at its distal end to the collar 24. As will be further described below, the inner shaft 16 is rotatable relative to the outer shaft 26 and the spacer body 14 to effect axial movement of the spacer body along the inner shaft 16 toward and away from the ventricular portion 12.

[0031] The spacer body 14 may comprise an annular metal frame 28 (FIG. 3) covered with a blood impermeable fabric 30 (FIGS. 1 and 2). FIG. 3 illustrates the spacer body 14 without the blood impermeable fabric 30 covering the frame 28. The frame 28 may comprise a mesh-like structure comprising a plurality of interconnected metal struts, such as a conventional radially compressible and expandable stent. In the illustrated configuration, the frame 28 has a generally spherical shape, although the frame may have a variety of other shapes in other alternative embodiments (e.g., cylindrical, conical, etc.). In other embodiments, the body may comprise a solid block of material, such as a flexible, spongy, and / or elastomeric block of material formed from a biocompatible polymer, such as silicone.

[0032] The frame 28 may be formed from a self-expanding material, such as Nitinol. If formed from a self-expanding material, the frame 28 may be radially compressed into a delivery configuration and held in the delivery configuration by placing the device within a sheath of a delivery apparatus. Once deployed from the sheath, the frame 28 may self-expand to a functional size. In other embodiments, the frame may be formed from a plastically expandable material, such as stainless steel or a cobalt chromium alloy. If formed from a plastically expandable material, the prosthetic device may be folded onto the delivery apparatus and radially expanded to a functional size by an inflatable balloon or equivalent expansion mechanism. It is noted that any of the embodiments disclosed herein may include a self-expanding or plastically expandable body.

[0033] The inner shaft 16 can be threaded, for example with external threads or a helical coil (as shown in Figures 1-3). The collar 24 has internal threads that engage with the windings of the coil or the external threads of the thread if the shaft is threaded. Thus, rotation of the inner shaft 16 relative to the outer shaft 26 has the effect of moving the collar 24 and thus the spacer body 14 along the length of the shaft 16. Rotation of the inner shaft 16 relative to the outer shaft 26 can be accomplished by rotating a rotatable torque shaft of a delivery device (such as that shown in Figures 6-8) that is removably coupled to the inner shaft 16. The delivery device can have an outer shaft that is removably coupled to the outer shaft 26 and configured to limit rotation of the outer shaft 26 while the inner shaft 16 is rotated by the torque shaft.

[0034] The device 10 can be delivered percutaneously to a native heart valve (e.g., mitral valve) with a delivery apparatus. FIG. 1 shows the spacer body 14 in a pre-anchored proximal position away from the ventricular portion 12 before attachment to the native leaflets of the mitral valve (the native leaflets are not shown in FIGS. 1-3). The anchors 20 are positioned in the left ventricle behind the native leaflets (preferably in the A2 and P2 regions of the leaflets as specified in the Carpentier nomenclature). The spacer body 14 is then moved (such as by rotating a torque shaft of the delivery apparatus) toward the ventricular portion 12 to the position shown in FIG. 2, such that the leaflets are captured between the anchors 20 and the spacer body 14.

[0035] When device 10 is secured to both leaflets, it draws them closer together around spacer body 14. In doing so, device 10 reduces the total area of ​​the mitral valve opening and partitions the mitral valve opening into two openings during diastole. Thus, the area over which mitral regurgitation can occur is reduced, leaflet coaptation can be initiated at the body 14, and the leaflets can more easily coapt completely, preventing or minimizing mitral regurgitation.

[0036] Due to the flexible nature of the body 14, the circumference and / or width / diameter of the spacer body 14 may be further expanded by compressing the spacer body 14 against the ventricular portion 12 by rotating the inner shaft 16. This action causes the body 14 to shorten axially and the mid-portion of the body 14 to expand radially by compressing the end portions of the body 14 between the anchor collar 24 and the ventricular portion 12. In contrast, moving the body 14 away from the ventricular portion 12 may cause the body to contract radially.

[0037] The adjustability of the device 10 provides several advantages over prior devices. For example, the device 10 may be advantageously used to change the degree of mitral regurgitation because the device 10 may be configured to accommodate different fusion lines by expanding or contracting the body 14, thus reducing the need to manufacture multiple devices. Another advantage is, for example, allowing a physician to adjust the body 14 to a desired configuration during the initial implant placement procedure without extensive pre-procedural measuring and monitoring. Prior devices require extensive measuring prior to the placement procedure to ensure that a properly sized implant is selected, but in this case, the physician is able to adjust the size of the body 14 during the implant placement procedure by monitoring the procedure with an echocardiogram and adjusting the body 14 to a desired configuration and size.

[0038] Also, advantageously, device 10 may be adjusted after the initial placement procedure to reposition, expand, or contract device 10 to achieve improved results over the initial configuration. Yet another advantage of device 10 is that anchor 20 and body 14 may be independently positioned. This is an advantage over prior systems because it is often difficult to simultaneously align the anchor and body due to leaflet movement during diastole and systole.

[0039] Additionally, the body 14 of the device 10 may be configured to address central jet mitral regurgitation and / or eccentric jet mitral regurgitation. Such configurations can include bodies 14 of various sizes and / or geometries.

[0040] 4 and 5 show another exemplary embodiment of an implantable prosthetic device 100. The device 100 comprises one or more ventricular anchors 102 (two in the illustrated embodiment), a spacer body 104, a threaded shaft 106, a proximal nut 108, and a distal stopper 116. The shaft 106 extends coaxially through the body 104, the nut 108, and the stopper 116.

[0041] The body 104 may include a distal first annular collar 110 disposed about the shaft 106 and positioned near the ventricular end of the body 104 of the device 100, a proximal second annular collar 112 disposed about the shaft 106 and positioned near the atrial end of the body 104 of the device 100, and a number of struts 114 extending between the first collar 110 and the second collar 112.

[0042] Each strut 114 may be secured to a first collar 110 about a first end of the strut 114 and to a second collar 112 about a second end of the strut 114. The struts 114 may be secured to the collars 110, 112, for example, by forming the struts 114 and collars 110, 112 from a single, unitary piece of material (e.g., laser cutting a metal tube). In other embodiments, the struts 114 may be secured to the collars 110, 112, for example, by adhesives, welding, fasteners, etc. Also, the anchor 102 is secured to the distal collar 110, such as by welding, fasteners, adhesives, etc. or by forming the anchor and collar from a unitary piece of material. Although not shown in FIGS. 4 and 5, the body 104 may be covered with a blood impermeable covering (e.g., fabric) similar to the fabric 30 shown in FIGS. 1 and 2.

[0043] In the illustrated embodiment, a distal stop 116 is secured to the shaft 106 and may function to prevent distal movement (to the left in FIGS. 4 and 5 ) of the distal collar 110 along the shaft 106. The proximal collar 112 may be secured to a nut 108, which has internal threads that engage with external threads on the shaft 106. As such, rotation of the shaft 106 causes the nut 108, and thus the proximal collar 112, to move toward and away from the distal collar 110, thereby radially expanding and contracting the struts 114, respectively.

[0044] The anchors 102 and struts 114 may be formed from a self-expanding material, such as Nitinol. If formed from a self-expanding material, the anchors 102 and struts 114 may be radially compressed into a delivery configuration and held in the delivery configuration by placing the device in a sheath of a delivery apparatus. Upon deployment from the sheath, the anchors 102 may expand radially to form a gap between the anchors 102 and struts 114 as shown in FIG. 4. In this configuration, the natural leaflets of the heart valve may be disposed in the gap between the anchors 102 and struts 114. The leaflets may then be secured between the anchors 102 and struts 114 by moving the proximal collar 112 axially along the shaft toward the distal collar 110 by rotating the shaft. Moving the proximal collar 112 toward the distal collar 110 causes the struts 114 to buckle or bend away from the longitudinal axis of the shaft 106 toward the anchor 102 as shown in FIG. 5. The axial position of the proximal collar 112 can be adjusted until the anchors 102 and struts 114 apply a clamping force against either side of each leaflet such that the device 100 maintains its position relative to the leaflets during diastole and systole.

[0045] Rotation of the shaft 106 relative to the nut 108 and body 104 may be accomplished by rotating a rotating torque shaft of a delivery device (such as that shown in FIGS. 6-8) that is removably coupled to the shaft 106. The delivery device can have an outer shaft that is removably coupled to the nut 108 and configured to limit rotation of the nut 108 while the shaft 106 is rotated by the torque shaft.

[0046] Although shaft 106 shown in FIGS. 4 and 5 comprises a rigid bolt, shaft 106 could comprise a flexible thread or a flexible helical coil similar to shaft 16 shown in FIGS.

[0047] In an alternative embodiment, the position of the entire body 104 (including the proximal collar 112 and the distal collar 110) may be adjusted axially along the length of the shaft 106 (in which case the stopper 116 is not fixed to the shaft 106). The position of the body 104 along the shaft may be accomplished by rotating the shaft 106 relative to the body, or vice versa. Once the desired position of the body 104 along the shaft 106 is achieved, a stop member 118 may be positioned along the shaft in abutting relationship against the stopper 116 (the stop member 118 is shown spaced from the stopper 116 in the drawings) to prevent further distal movement of the body 104 along the shaft. Further rotation of the shaft 106 causes the proximal collar 112 to move toward the distal collar 110 causing the struts 114 to expand.

[0048] In another embodiment, the distal portion of the shaft 106 may be threaded in one direction and the proximal portion of the shaft 106 may be threaded in the opposite direction. The threads on the proximal portion of the shaft engage the internal threads of the nut 108. Similarly, the stopper 116 may include a nut having internal threads that engage the threads on the distal portion of the shaft. In this manner, similar to a turnbuckle, rotation of the shaft relative to the body 104 in a first direction causes the distal collar 110 and the proximal collar 112 to move towards each other, and rotation of the shaft relative to the body 104 in a second direction (opposite the first direction) causes the distal collar 110 and the proximal collar 112 to move away from each other.

[0049] 6-8 show another embodiment of an implantable prosthetic device 200 being deployed from a delivery apparatus 202 into the mitral valve via a transseptal technique. The prosthetic device 200 can include an expandable spacer body 204, one or more ventricular anchors 206 (two in the illustrated embodiment) coupled to and extending from a distal end portion of the spacer body 204, a shaft 208 extending through the spacer body 204, and a nut 210 disposed on the shaft 208. The nut 210 can have internal threads that engage with external threads on the shaft 208 and can be limited in rotational movement such that rotation of the shaft 208 moves the nut 210 axially along the length of the shaft 208.

[0050] The delivery apparatus 202 may include an outer catheter 212 and an implant catheter 214. The implant catheter 214 may include a delivery sheath 216, a nut support shaft 218, and a torque shaft 220. Prior to insertion into the patient's body, the prosthetic device 200 may be coupled to the nut support shaft 218 and the torque shaft 220 and loaded into the delivery sheath 216. The outer catheter 212 may be advanced through the femoral vein, the inferior vena cava into the right atrium, and across the septum 222 into the left atrium 224 (as shown in FIG. 6). The outer catheter 212 may be advanced over a guidewire 226, which may be inserted into the patient's vasculature and used to cross the septum 222 before introducing the outer catheter 212 into the patient's body. As further shown in FIG. 6, the implant catheter 214, together with the prosthetic device 200, may be inserted through the outer catheter 212 into the left atrium 224. The implant catheter 214 can be advanced past the native mitral valve leaflets 228 until the anchors 206 of the prosthetic device are located within the left ventricle.

[0051] 7, the delivery sheath 216 may then be retracted to expose the prosthetic device 200. The spacer body 204 may self-expand to a radially expanded state when deployed from the delivery sheath 216. Alternatively, the spacer body 204 may be held in a radially compressed state by the nut support shaft 218 when the spacer body is deployed from the sheath 216. After deployment of the prosthetic device 200 from the sheath 216, the torque shaft 220 may be rotated to open the anchors 206 to a desired position for capturing the valve leaflets 228.

[0052] The anchor 206 may be positioned behind the end of the leaflet 228 (e.g., desirably at the A2 and P2 positions). The leaflet 228 may then be secured between the anchor 206 and the spacer body 204 by moving the nut 210 axially along the anchor 206 in a proximal direction by rotating the torque shaft 220 and the shaft 208. The movement of the nut 210 has the effect of biasing the anchor 206 radially inward against the leaflet 228 (as shown in FIG. 8). Thus, the prosthetic device 200 may be secured to the leaflet 228 by clamping the leaflet 228 between the anchor 206 and the body 204. Thereafter, as shown in FIG. 8, the nut support shaft 218 and the torque shaft 220 may be removed from the prosthetic device and the implant catheter may be retracted into the outer catheter.

[0053] FIGURE 9 illustrates an exemplary implantable prosthetic device 300 according to another embodiment. The prosthetic device 300 in the illustrated embodiment includes a ventricular portion 302, a spacer body 304, a shaft 306, and a proximal end portion 308. The ventricular end portion 302 includes one or more anchors 310 (two in the illustrated embodiment) extending from the ventricular end of the shaft 306. FIGURE 9 also illustrates a guidewire 320 extending through the device 300. The guidewire 320 may be used during a device placement procedure (described below).

[0054] As shown in FIG. 10, device 300 may be formed from a single, unitary piece of material. In some embodiments, separate components of device 300 may be formed from separate pieces of material that may be secured together by adhesives, welding, fasteners, etc. Device 300 may be formed from a self-expanding braided material. The braided material may be formed from metal threads such as Nitinol. If formed from a braided material, device 300 may be covered with a blood impermeable covering (similar to fabric 30 shown in FIGS. 1 and 2) or a flexible sealant material such as expanded polytetrafluoroethylene (commonly referred to as "ePTFE") that allows the braided material to expand and / or flex while still preventing blood flow through device 300.

[0055] In the illustrated embodiment, the body 304 of the device 300 has a generally spherical shape, although the body 304 can have a variety of other shapes (e.g., cylindrical, conical, etc.) in other embodiments. The body 304 of the device 300 can also be configured to address central jet mitral regurgitation and / or eccentric jet mitral regurgitation. Such configurations can include bodies 304 of various sizes and / or geometries. As illustrated, the body 304 of the device 300 can be an integral component of the device 300 formed from a single, unitary piece of self-expanding braided material, such as braided nitinol. In other embodiments, the body 304 can be formed from separate pieces of material including different materials, such as plastically expandable or polymeric materials (similar to those described above with reference to the spacer body 14).

[0056] When formed from a self-expanding braided material, the device 300 can be radially compressed into a delivery configuration (shown in FIG. 10) and held in the delivery configuration by placing the device 300 within a sheath of a delivery apparatus. The device 300 can be radially compressed by axially stretching the device 300 by expanding the anchors 310 so that they extend from the ventricular end of the shaft 306 away from the proximal end 308 parallel to the shaft 306, and by radially compressing the spacer body 304 to substantially the same diameter as the shaft 306, as shown in FIG. 10. With the device 300 in the delivery configuration, the device 300 can be delivered percutaneously with a delivery apparatus to a native heart valve (e.g., the mitral valve).

[0057] Once the device 300 has been delivered percutaneously with a delivery apparatus to the native heart valve, the delivery sheath may be removed from the device 300, allowing the device 300 to fold and expand to the expanded state shown in Figures 11 and 12. The native leaflets (not shown in Figures 11 and 12) are captured between the anchors 310 of the device 300 and the spacer body 304, which brings the native leaflets closer together around the spacer body 304. In this way, the device 300 reduces the total area of ​​the mitral valve opening and divides the mitral valve opening into two openings during diastole. Thus, the area over which mitral regurgitation can occur is reduced, leaflet coaptation may be initiated at the body 304, and the leaflets may more easily coapt completely, preventing or minimizing mitral regurgitation.

[0058] 13-17, for example, show device 300 being delivered to the mitral valve using delivery apparatus 312. Delivery apparatus 312 may include an outer catheter (not shown) and a device catheter 314. Device catheter 314 may include a delivery sheath 316 and a shaft 318. Prior to insertion into the patient's body, proximal end 308 of device 300 may be removably coupled to shaft 318 of device catheter 314 and loaded within delivery sheath 316, thus holding device 300 in a delivery configuration.

[0059] A guidewire 320 may be advanced through the patient's femoral vein, inferior vena cava into the right atrium, across the septum 322 into the left atrium 324, and across the mitral valve leaflet 326 into the left ventricle 328. An outer catheter may be advanced over the guidewire 320 and into the left atrium 324. The device catheter 314, along with the device 300, may be advanced over the guidewire 320 through the outer catheter into the left atrium 324. The device catheter 314 may be advanced past the mitral valve leaflet 326 until the anchor 310 of the device 300 is located in the left ventricle 328.

[0060] As shown in Figure 13, the delivery sheath 316 of the device catheter 314 may then be retracted to expose the anchor 310 of the device 300. Exposing the anchor 310 may cause the anchor 310 to self-expand from an unfolded, radially compressed delivery configuration (shown in Figure 10) to a folded, radially expanded configuration (Figures 9, 11-12). With the anchor exposed, the shaft 318 of the delivery catheter 314 may be rotated to orient the anchor 310 to a desired position for capturing the valve leaflet 326.

[0061] As shown in Fig. 14, the anchors may be positioned behind the ventricular portion of the leaflet 326 (e.g., desirably at the A2 and P2 positions). Fig. 15 shows that the delivery sheath 316 of the device catheter 314 may then be further retracted to expose the spacer body 304 of the device 300, thereby allowing the body 304 to self-expand into a radially expanded configuration. In the expanded configuration, the body 304 of the device 300 contacts the atrial portion of the leaflet 326. The leaflet is thus secured between the anchor 310 and the body 304 of the device 300 by clamping the leaflet 326 between the anchor 310 and the body 304 with a compressive force being applied by the anchor 310 and the body 304 to the ventricular and atrial portions of the leaflet 326, respectively.

[0062] With the leaflets 326 secured between the anchor and body, the shaft 318 of the device catheter 314 can be decoupled from the proximal end 308 of the device 300 (as shown in FIG. 16) and the device catheter 312 can be retracted into the outer catheter. The outer catheter and guidewire 320 are then each retracted and removed from the patient as shown in FIG. 17. The device 300 can have an inner foam core such that when the guidewire 320 is retracted through the device, the inner foam of the device seals the guidewire lumen to prevent blood flow through the device 300.

[0063] 18 illustrates an exemplary implantable prosthetic device 400 having a similar overall configuration as device 300, including a ventricular end portion 402, a spacer body 404, a shaft 406, and a proximal end portion 408. The ventricular end portion 402 includes one or more anchors 410 (two in the illustrated embodiment) extending therefrom. The spacer body 404 includes a plurality of friction elements 416. For example, each of the plurality of friction elements 416 can include an outward protrusion that can push and / or penetrate into the leaflet tissue to minimize leaflet migration between the anchor 410 and the body 404 and improve tissue ingrowth, as shown in FIG. 18. In another embodiment, the friction elements can include a textured surface formed in and / or applied to the blood impermeable covering of the body 404.

[0064] The device 400 may also include one or more wires, sutures, tethers, or strings 412 (two in the illustrated embodiment) and a clip 414. The wires 412 may include a distal end 418, a proximal end 420, and an intermediate portion 422 positioned between the distal end 418 and the proximal end 420. The distal end 418 of each wire 412 may be securely secured to a respective anchor 410 of the device 400 by adhesive, welding, fasteners, or the like. The proximal ends 420 of the wires 412 may each be removably coupled to an additional wire (not shown) of the delivery apparatus. The intermediate portions 422 of the wires 412 each extend coaxially through the shaft 406, body 404, and clip 414 of the device 400. The clips 414 may be securely secured to the proximal end 408 of the device 400 by adhesive, welding, fasteners, or the like. Clip 414 is also adjustably coupled to wire 412 and may be removably coupled to a delivery device (not shown).

[0065] Device 400 may be delivered percutaneously to a native heart valve (eg, the mitral valve) using a delivery apparatus and delivery technique similar to those described above in connection with device 300 (see Figures 13-17).

[0066] Due to the flexible nature of the device 400 and the addition of the wire 412 and clip 414, the clamping force on the leaflets can be further increased by applying tension to the proximal end 420 of the wire 412 (pulling the wire proximally in the direction of arrow 424) while maintaining the axial position of the clip 414. This action pulls the anchor 410 towards the body 404, thereby reducing the space between the anchor 410 and the body 404. This tension can be applied to the proximal end of the wire 412, such as by pulling an additional wire of a delivery apparatus that can be removably coupled to the proximal end of each wire 412 of the device 400. The clip 414 can be configured to retain the axial position of the wire 412 when tension is removed. For example, the clip 414 can be configured to allow axial movement of the wire 412 in the proximal direction 424 when tension is removed, but prevent axial movement of the wire 412 in the reverse direction. In another embodiment, for example, wire 412 can include teeth and clip 414 can include a pawl, forming a ratchet that can move wire 412 only in a proximal direction relative to clip 414.

[0067] Figure 19 shows an exemplary thermoforming sequence utilized to manufacture devices 300, 400. Devices 300, 400 may be formed by placing a tubular braided piece of self-expanding material on a mandrel and then annealing the material in the configuration shown in Figures 19a-19h. When formed in this sequence, the device will expand in the same sequence upon exposure from the delivery sheath.

[0068] 20-24 show an exemplary embodiment of an implantable prosthetic device 500, similar to device 300, according to another embodiment. The prosthetic device 500 in the illustrated embodiment comprises a ventricular portion 502, a spacer body 504, and an inner shaft 506 to which the ventricular portion 502 and the spacer body 504 are attached.

[0069] As best shown in FIG. 22 (which shows the device in a compressed delivery state), the ventricular portion 502 comprises a distal end 508 and a proximal end 510 (shown in FIG. 22) disposed respectively on the shaft 506, and one or more ventricular anchors 512 (one in the illustrated embodiment) extending from the distal end portion 508. In some embodiments (shown in FIG. 21b), the ventricular portion 502 may further comprise one or more apertures 522 located near the distal end 508 of the ventricular portion 502. Although the device 500 as shown in FIG. 21b has two apertures 522, these apertures are of the same shape and size and are located opposite one another (circumferentially), so that only one aperture is visible. As will be explained further below, such apertures 522 effectively form multiple ventricular anchors 512 (two in FIG. 21b) when the ventricular portion 502 is folded into a radially expanded state. In an alternative embodiment, the ventricular portion 502 of the device 500 may have, for example, three openings 522, thereby effectively forming three anchors for use in a heart valve with three native leaflets (e.g., a tricuspid valve).

[0070] A distal sleeve 514 may be inserted over the distal end 508 of the ventricular portion 502 and attached to the distal end of the shaft 506 to radially compress the distal end 508 against the inner shaft 506 and retain the ventricular portion 502 on the shaft 506. The proximal end 510 of the ventricular portion 502 is attached to the distal end of an intermediate sleeve 516 disposed on the shaft 506 (shown in FIG. 22 ). The spacer body 504 is attached at its distal end to the proximal end of the intermediate sleeve 516 and at its proximal end to the distal end of a proximal sleeve or shaft 518 that extends coaxially beyond the proximal end of the inner shaft 506. Thus, the inner shaft 506 extends coaxially through the proximal sleeve 518, the spacer body 504, the intermediate sleeve 516, the ventricular portion 502, and the end cap 514. The inner shaft 506 is axially movable relative to the proximal sleeve 518 and the intermediate sleeve 516 to effect expansion of the device 500 during delivery of the device, as described further below.

[0071] As shown, the ventricular portion 502 and the spacer body 504 of the device 500 may be formed from a single unitary piece of material. If the ventricular portion 502 and the spacer body 504 of the device 500 are formed from a single piece of material, the intermediate sleeve 516 may be optional. However, in alternative embodiments, the ventricular portion 502 and the spacer body 504 of the device 500 may be formed from separate pieces of material. If the ventricular portion 502 and the spacer body 504 of the device 500 are formed from separate pieces of material, the proximal end 510 of the ventricular portion 502 and the distal end of the spacer body 504, respectively, may be coupled to the intermediate sleeve 516 by adhesive, welding, fasteners, etc. Alternatively, the proximal end 510 of the ventricular portion 502 and the distal end of the spacer body 504, respectively, may be coupled directly together by adhesive, welding, fasteners, etc. without the use of the intermediate sleeve 516.

[0072] In the illustrated embodiment, the spacer body 504 of the device 500 has a generally spherical shape, however, the body 504 can have various shapes in other embodiments (e.g., cylindrical, conical, etc.). Additionally, the body 504 of the device 500 can be configured to address central jet mitral regurgitation and / or eccentric jet mitral regurgitation. It is noted that any of the devices disclosed herein can include spacer bodies of various shapes and can be configured to address central jet mitral regurgitation and / or eccentric jet mitral regurgitation.

[0073] As shown in FIG. 20, the ventricular portion 502 and the spacer body 504 of the device 500 may be formed from a self-expanding braided material. The braided material may be formed from metallic threads such as Nitinol. As with the devices described above, the braided material of the device 500 may be covered with a blood impermeable cover or a flexible sealant material that prevents blood flow through the device 500. FIG. 20 shows the device 500 in a radially expanded state. The device 500 may be radially compressed into a delivery configuration by moving the distal end 508 of the ventricular portion away from the proximal end of the spacer body 504, effectively stretching or elongating the device into a radially compressed tubular configuration (as shown in FIGS. 21 and 22). With the device 500 in the delivery configuration, the device 500 may be delivered percutaneously to a native heart valve (e.g., the mitral valve) in the same manner as the delivery apparatus 312 described above.

[0074] With the delivery apparatus sheath 520 positioned within the left ventricle, the ventricular portion 502 of the device 500 is advanced out of the delivery catheter sheath by axially advancing the inner shaft 506 and proximal sleeve 518 of the device 500, allowing the ventricular portion 502 to extend from within the delivery sheath into the left ventricle. The ventricular portion may then be collapsed and expanded by axially retracting the inner shaft 506 relative to the proximal sleeve 518 and delivery sheath 520, as shown in FIG. 23. In this configuration, the anchor may be placed against the ventricular portion of the native valve leaflet.

[0075] The leaflets may then be secured by retracting the proximal sleeve 518 axially relative to the inner shaft 506 and delivery sheath 520, thereby radially expanding the body 504 as shown in FIG. 24. This action captures the leaflets between the anchors 512 of the device 500 and the spacer body 504, which brings the leaflets closer together around the spacer body 504. In doing so, the device 500 reduces the total area of ​​the mitral valve opening and partitions the mitral valve opening into two openings during diastole. Thus, the area through which mitral regurgitation can occur is reduced, leaflet coaptation may be initiated at the body 504, and the leaflets may more easily coapt completely, preventing or minimizing mitral regurgitation. With the leaflets captured and the device 500 expanded to a functional state, the proximal sleeve 518 can be decoupled from the proximal end of the body 504 and retracted into the delivery sheath 520, and then both the proximal sleeve 518 and the delivery sheath 520 can be retracted from within the patient's body.

[0076] Although devices 300, 400, 500 show one or two anchors, in some embodiments devices 300, 400, 500 can have, for example, three anchors and can be delivered to a native heart valve having three leaflets (e.g., a tricuspid valve). Note that any of the embodiments disclosed herein can include one or more anchors.

[0077] 25-34 show an exemplary embodiment of an implantable prosthetic device 600, similar to device 500, according to another embodiment. The prosthetic device 600 in the illustrated embodiment comprises an inner shaft 602, a distal end cap 604, a braided section 606, and an outer shaft 608. The braided section 606 comprises one or more anchor portions 610 (two in the illustrated embodiment) and a body portion 612. The inner shaft 602 extends coaxially through the outer shaft 608, the body 612 of the braided section 606, and the end cap 604. The end cap 604 may be securely fixed to the distal end of the inner shaft 602 to prevent axial movement of the end cap 604 along the inner shaft 602.

[0078] Each anchor 610 of the braided portion 606 includes a lower leg portion 614, an upper leg portion 616, and a junction 618 positioned between each lower leg 614 and upper leg 616, which junction 618 is defined by a crease in the leg portion when deployed. The distal end of the lower leg 614 may be secured within the end cap 604 to retain the distal end of the lower leg 614 relative to the inner shaft 602 and prevent axial movement relative to the inner shaft 602. The proximal end of the upper leg 616 may be attached to the distal end of the body 612 of the braided portion 606. The proximal end of the body 612 of the braided portion 606 may be removably attached to the distal end of the outer shaft 608 by inserting the proximal end of the body 612 into the distal end of the outer shaft 608, or by a separate retention device that couples the proximal end of the body to the end of the outer shaft 608. The outer shaft 608, and thus the body 612, can be adjustably movable axially relative to the inner shaft 602 to achieve configuration of the device 600 during a device placement procedure, as described further below.

[0079] The end cap 604 may be fixedly secured to the distal end of the inner shaft 602 by, for example, adhesives, welding, fasteners, etc. Alternatively, the end cap 604 may be fixedly secured to the distal end of the inner shaft 602 by, for example, forming the end cap 604 and the inner shaft 602 from a single unitary piece of material.

[0080] In some embodiments, the anchors 610 can be independently movable relative to one another. For example, the device 600 can have multiple inner shafts 602 that are independently movable relative to one another, with each anchor 610 coupled to a respective inner shaft 602.

[0081] The outer shaft 608 may be adjustably movable axially relative to the inner shaft 602, such as by pushing or pulling the outer shaft 608 axially relative to the inner shaft, or vice versa. In alternative embodiments, for example, the inner shaft 602 may include external threads and the outer shaft 608 may include internal threads that engage the external threads of the inner shaft 602. Thus, rotation of the outer shaft 608 relative to the inner shaft has the effect of moving the outer shaft 608, and thus the spacer body 612, along the length of the inner shaft 602.

[0082] The braided portion 606 of the device 600 may be formed from a single, unitary piece of braided material. The braided material may be formed from a self-expanding metal thread, such as Nitinol. For example, FIG. 26 shows the braided portion 606 of the device 600 formed from a single piece of braided material, with the anchor portion 610 extended in a splayed configuration and the body 612 slightly expanded. In an alternative embodiment, the anchor 610 and the body 612 may be formed from separate pieces of braided material, in which case the anchor 610 and the body 612 may be coupled by attaching the proximal end of the upper leg 616 of the anchor 610 and the distal portion of the body 612 to a coupling sleeve 620 (shown in FIG. 25). If formed from a self-expanding material, the braided portion 606 may be radially compressed into a delivery configuration and held in the delivery configuration by placing the device 600 within a sheath of a delivery apparatus, as shown in FIG. 27. Upon deployment from a delivery sheath, the braided portion 606 of the device 600 may self-expand into a functional configuration as described further below.

[0083] The device 600 can be delivered percutaneously to a native heart valve (e.g., the mitral valve) with a delivery apparatus. Figures 27-34 show the device 600 being deployed from a delivery apparatus. The delivery apparatus can include an outer catheter (e.g., outer catheter 520 of Figure 23) and an implant catheter 622. The implant catheter 622 can include a delivery sheath 624, an inner shaft (not shown), and an outer shaft 608 (shown in Figure 25). The inner shaft and outer shaft 608 extend coaxially through the delivery sheath 624 of the implant catheter 622, and the inner shaft extends coaxially through the outer shaft 608 of the implant catheter 622.

[0084] Prior to insertion into the patient's body, the proximal ends of the inner shaft 602 of the prosthetic device 600 are respectively coupled to the distal end of the inner shaft (not shown) of the implant catheter 622, the outer shaft 608 is bonded to the proximal end of the spacer body 612, and the prosthetic device 600 can then be loaded into the delivery sheath 624. The delivery apparatus can then be advanced into the patient's heart (not shown), such as by the transseptal technique described above (see Figures 6-8). Figure 27 shows the sheath 624 of the implant catheter 622 holding the prosthetic device 600 in a delivery configuration. In this configuration, the implant catheter can be advanced past the native mitral valve leaflets of the heart (not shown) until the distal end of the inner shaft 602 and the end cap 604 of the device 600 are located within the left ventricle (similar to the positioning shown in Figure 6).

[0085] 28, the anchors 610 of the braided portion 606 of the device 600 may be exposed by advancing the inner and outer shafts 608 of the implant catheter 622 distally relative to the delivery sheath 624 and / or retracting the delivery sheath 624 relative to the inner and outer shafts 608, thus pushing the anchors 610 out of the sheath 624. Once exposed from the sheath 624, the joints 618 of the anchors 610 may expand radially away from the inner shaft 602, as shown in FIG. 30 and 31 , the anchor 610 may be folded by retracting the inner shaft of the implant catheter 622 (which is coupled to the inner shaft 602 of the implant 600) relative to the outer shaft 608 and sheath 624, which in turn retracts the inner shaft 602, bending the anchor 610 at the junction and folding the upper leg 616 inwardly toward the inner shaft 602. In this configuration, the anchor 610 may be positioned behind the ventricular portions of the valve leaflets (e.g., desirably at the A2 and P2 positions).

[0086] The body 612 of the braided portion 606 of the device 600 may be exposed by further retracting the delivery sheath 624 relative to the inner and outer shafts of the implant catheter (as in FIG. 32 ) and / or advancing the shaft distally relative to the sheath 624, thereby allowing the body 612 to radially expand (as shown in FIG. 33 ), thereby capturing the valve leaflets between the upper leg 616 of the anchor 610 and the spacer body 612. The valve leaflets can then be secured between the upper leg 616 of the anchor 610 and the braided spacer body 612 by advancing the outer shaft 608 of the implant catheter 622 relative to the inner shaft 602 and the delivery sheath 624 of the implant catheter 622, causing the spacer body 612 to move axially toward the distal end of the inner shaft 602 until it abuts the end cap 604, at which point further advancement of the outer shaft compresses the end portions of the spacer body 612 between the end cap 604 and the outer shaft 608, thereby securing the valve leaflets between the upper leg 616 of the anchor 610 and the braided spacer body 612.

[0087] By squeezing the ends of the spacer body 612 together, the spacer body 612 is axially shortened and radially expanded, which forces the spacer body 612 radially outward against the valve leaflets, as shown in Figure 34. Thus, the device 600 may be secured by clamping the valve leaflets between the upper legs 616 of the anchors 610 of the braided portion 606 and the spacer body 612 of the braided portion 606. The inner and outer shafts of the implant catheter 622 may then be detached from the device 600 and the delivery apparatus may be removed from the patient.

[0088] 35 illustrates an exemplary embodiment of an implantable prosthetic device 900 similar to device 600, including a braided portion 906, according to another embodiment. The braided portion 906 of the device 900 includes one or more anchors 910 (two are shown in the illustrated embodiment) and a spacer body 912. As illustrated, the anchors 910 of the braided portion 906 of the device 900 may be formed from a piece of braided material that is separate from the piece of braided material that forms the spacer body 912. Each of the anchors 910 includes a lower leg 914 and an upper leg 916. Each upper leg 916 may be inserted and fitted into an end cap 904 disposed on a distal end of an inner shaft (not shown) of the device 900. Each lower leg 914 may be coupled to the other lower leg 914. For example, in some embodiments, the lower legs 914 of the anchors 910 may be formed from a single continuous piece of braided material as shown in Figure 35 as laterally extending sections that are perpendicular to the spacer body 912. In some embodiments (where each anchor 910 is formed from a separate piece of braided material), the lower legs 914 may be coupled, for example, by inserting the ends of the lower legs 914 into a coupler or sleeve, which compresses and secures the ends of the lower legs 914 within the coupler.

[0089] 36 illustrates another exemplary embodiment of an implantable prosthetic device 700. The device 700 comprises one or more ventricular anchors 702 (two in the illustrated embodiment), a spacer body 704, one or more anchor actuating lines 706 (two are shown in FIG. 36), and a pull wire 708. The actuating lines 706 and pull wire 708 extend coaxially through the body 704.

[0090] The anchor 702 can comprise a number of leaflet retaining elements 712. For example, Fig. 36 shows that the retaining elements 712 can comprise outwardly extending protrusions or barbs that can be pressed and / or penetrate into the leaflet tissue to secure the anchor 702 to the leaflet. In another embodiment, the retaining elements can comprise a textured surface formed in and / or applied to the anchor 702 of the device 700.

[0091] The spacer body 704 may include a collar 710 positioned near the ventricular end of the body 704 of the device 700 and a braided portion 714. Although the braided portion has a generally cylindrical shape when in the expanded configuration shown in the illustrated embodiment, the braided portion may have a variety of other shapes in other alternative embodiments. For example, the braided portion may expand to a generally spherical shape (similar to the body 504 of FIG. 20).

[0092] Braided portion 714 may be secured to collar 710 by adhesive, welding, fasteners, etc. Anchor 702 may also be secured to collar 710. In some embodiments, anchor may be secured to collar 710 by, for example, welding, fasteners, or adhesives. In alternative embodiments, anchor 702 may be secured to collar 710 by, for example, forming anchor 702 and collar 710 from a single piece of material (e.g., laser cutting a metal tube).

[0093] The anchor actuating lines 706 can be wires or sutures formed from a variety of materials, such as nylon, polyester, PVDF, polypropylene, stainless steel, etc. Each line 706 includes a first end 716 secured or coupled to a respective free end of the anchor 702, a second end (not shown) secured or coupled to a distal end of the pull wire, and an intermediate portion positioned between the first end 716 and the second end. In the illustrated embodiment, each of the lines 706 beginning at the first end 716 and moving toward the second end extends outwardly away from the free end of the anchor 702, downwardly toward and coaxially through a collar 710 of the body 704, and coaxially into a braided portion 714 of the body 704 where it is secured to a pull wire 708.

[0094] Anchor 702 may be formed from a self-expanding material, such as Nitinol, and braided portion 714 of body 704 may be formed from a self-expanding material, such as braided Nitinol. If formed from a self-expanding material, anchor 702 and braided portion 714 of body 704 may be radially compressed into a delivery configuration and held in the delivery configuration by placing device 700 within a sheath of a delivery apparatus.

[0095] 36, upon deployment from the sheath, the anchor 702 and braided portion 714 may expand radially to form a gap between the anchor 702 and the braided portion 714 of the body 704 in which the natural leaflets 718 of the heart valve may be positioned. The leaflets 718 may then be secured between the anchor 702 and the braided portion 714 by applying tension to the pull wire 708 and thereby the line 706, bending or flexing the free end of the anchor 702 outwardly and causing the portion of the anchor 702 disposed between the free end and the fixed end of the anchor 702 (i.e., the middle portion) to buckle inwardly, thereby forcing the retention element into the leaflets 718. With the retention element 712 inserted within the leaflets 718, the device 700 may maintain a position relative to the leaflets during diastole and systole.

[0096] 34-47 show another exemplary embodiment of an implantable prosthetic device 800 and its components. In the illustrated embodiment, the device 800 comprises one or more ventricular anchors 802 (two in the illustrated embodiment), a spacer body 804, and an inner shaft portion 806. The inner shaft portion 806 extends coaxially through the spacer body 804. The anchors 802 press radially inward toward the inner shaft portion 806 to generate a clamping force between the anchors 802 and the spacer body 804, as described further below.

[0097] Figures 41-44 show the anchor 802 and spacer body 804 of the device 800 in an extended state. Figure 45 shows the anchor 802 and spacer body 804 of the device 800 in a folded or compressed delivery state. Figure 46 shows the anchor 802 of the device 800 in a functional state.

[0098] 37 illustrates that the spacer body 804 may comprise a metal frame comprising a distal first annular collar 808 disposed about the shaft 806 and positioned near the ventricular end of the spacer body 804 of the device 800, a proximal second annular collar 810 disposed about the shaft 806 and positioned near the atrial end of the spacer body 804 of the device 800, and a plurality of interconnecting struts 812 extending between the first collar 808 and the second collar 810. The struts 812 may be secured to the collars 808, 810, for example, by forming the struts 812 and collars 808, 810 from a single unitary piece of material (e.g., laser cutting a metal tube). In other embodiments, the struts 812 may be secured to the collars 808, 810, for example, by adhesive, welding, fasteners, etc. Although not shown in Figures 37-47, the frame may be covered with a blood impermeable covering (eg, fabric) or may be covered with a flexible sealant (eg, ePTFE).

[0099] FIG. 37 also illustrates that each of the anchors 802 of the device 800 may include a flexible tube portion 814. The tube 814 may be formed from an alloy tubing, such as, for example, Nitinol, stainless steel, cobalt chrome, or the like. The proximal end of the tube 814 may be fixedly secured or bonded to the distal collar 808, such as, for example, by adhesive, welding, fasteners, or the like. The tube 814 may also be configured to bend more easily in a desired direction and / or through a tighter bend radius without plastic deformation (e.g., kinking). For example, as shown, a portion of the circumference of the tube 814 may be formed (e.g., by laser cutting) such that a section of the tube includes a plurality of axially spaced circumferential ribs 830 on a first cut side of the tube and a non-opening or spine 832 on a second, uncut side opposite the cut side about the circumference of the tube. Cutting the tube on one side allows the tube 814 to bend more easily toward the side of the tube having the ribs 830 relative to the side having the spines 832.

[0100] The tubes 814 can also be cut asymmetrically relative to the longitudinal axis of the tubes 814 such that the ribs 830 are oriented on respective sides of the tubes 814 with respect to respective axial sections. For example, as shown, the tubes 814 each include a first cut section 838 located near a proximal end of the tube 814 (which ends are fixedly secured to the distal collar 808) such that the ribs 830 face outwardly (i.e., away from each other) when the tube is extended or straightened in the folded or delivery configuration (shown in FIG. 45 ) and a second cut section 840 located more distally relative to the first cut section 838 such that the ribs 830 face inwardly (i.e., toward each other) when the tube is extended or straightened in the folded or delivery configuration. The first cut section 838 and the second cut section 840 can be separated by, for example, a non-cut transition section 834 (FIG. 37).

[0101] In some embodiments, the individual axial sections may be formed from a single piece of material. In other embodiments, the individual axial sections may be formed from separate pieces of material that are secured or bonded together. Also, the ribs of the individual axial sections may be different sizes so that each axial section may bend somewhat tighter. For example, as shown, in the proximal section 838, the ribs 830 of the tube 814 may be relatively thinner (i.e., a greater portion of the tubing has been removed during the cutting process) than the ribs 830 of the second, more distal section 840, such that the first section 838 may have a smaller bend radius relative to the second section 840. Thus, by cutting the tube 814 and orienting the ribs 830, the manner and sequence in which the tube bends / buckles and extends / straightens may be controlled, as described further below.

[0102] 38 shows the device 800 with the tubes 814 of the anchors 802 removed, thus exposing the pull wires 816 (two are shown) of the anchors 802. As described further below, the pull wires 816 may each extend coaxially within a respective tube 814 of the anchor 802 and may be secured to the shaft portion 806 at a first proximal end 842 ( FIG. 40 ) of the pull wires 816 and secured to an interior portion of the tube 814 near its distal end at a second distal end 844 of the pull wires 816. As described further below, the pull wires 816 may be used to move the anchors 802, for example, from a folded delivery state (shown in FIG. 45 ) to an extended state (shown in FIG. 37 ), and / or to secure the native valve leaflets between the anchors 802 and the spacer body 804.

[0103] As best seen in FIGS. 39-40 , the shaft assembly 806 of the device 800 in the illustrated configuration includes a threaded bolt 818, a washer 820, and a shaft or shim support sleeve 822. The threaded portion of the bolt 818 extends coaxially through the washer 820 and sleeve 822 of the shaft 806. The bottom (distal) surface of the head portion of the bolt 818 abuts the top (proximal) surface of the washer 820. The bottom (distal) surface of the washer 820 abuts the proximal end of the sleeve 822 of the shaft assembly 806 and the proximal end of the proximal collar 810 of the spacer body 804. The sleeve 822 may be securely secured at each end of the sleeve 822 to the inner surfaces of the collars 808, 810 of the spacer body 804.

[0104] The shaft 806 may also include a nut 824 and nut support rails 826 (two shown), as best seen in FIG. 40. The nut 824 is disposed on the threaded portion of the bolt 818 and within the sleeve 822. The nut 824 may include internal threads that correspond to the threaded bolt 818. The nut 824 may also include a number of axially extending external notches or grooves 828 through which the rails 826 and pull wires 816 extend to prevent the nut 824 from rotating relative to the bolt 818, thereby causing axial movement of the nut as the bolt is rotated. The rails 826 may be rigidly secured to the sleeve 822 to prevent the rails 826, and therefore the nut 824, from rotating relative to the spacer body 804.

[0105] Rotating the bolt 818 may cause the nut 824 to slide axially along the rail 826 and move axially along the threaded portion of the bolt 818 either proximally or distally (depending on the direction of rotation) without rotation. The proximal end of the pull wire 816 of the anchor 802 may be rigidly secured to the nut 824. Thus, rotation of the bolt 818 causes the nut 824 and thus the pull wire 816 to move proximally or distally (depending on the direction of rotation). Rotating the bolt 818 such that the wire 816 moves proximally (in the direction of arrow 846) applies a compressive force to the tube 814, causing the tube 814 of the anchor 802 to bend or buckle from a straight delivery configuration to a functional state.

[0106] As shown, the pull wire 816 may be sufficiently stiff to apply a pushing force. Thus, by rotating the bolt 818 to move the pull wire 816 distally, tension is applied to the tube 814 causing the tube to extend and / or straighten into the delivery configuration (shown in FIG. 45 ). In an alternative embodiment, the tube 814 may be formed from a shape memory material (e.g., Nitinol) that is preformed into a straight delivery configuration. Thus, by rotating the bolt 818 to move the pull wire 816 distally, compression is removed from the tube 814 causing the tube 814 to straighten into the delivery configuration.

[0107] The device 800 may be delivered percutaneously with a delivery device (not shown) to a native heart valve (e.g., the mitral valve), for example, by utilizing the transseptal techniques described with respect to the prosthetic device 200 and delivery device 202 (shown in FIGS. 6-8). The device 800 and associated delivery device may be advanced past the native mitral valve leaflets 836 (similar to the configuration shown in FIG. 6) until the anchors 802 of the device 800 are located within the left ventricle. The device 800 may be advanced from a delivery sheath (not shown, but similar to sheath 216) to expose the anchors 802.

[0108] In some embodiments, the anchor 802 can be self-expanding (e.g., formed from a shape memory material such as Nitinol) such that when deployed from a delivery sheath similar to device 300 (as shown in FIGS. 13 and 14 ), it can transition from a delivery configuration (best illustrated in FIG. 45 ) to a leaflet capturing configuration (best illustrated in FIG. 47 ). If formed from a self-expanding material, the shaft 806 and pull wire 816 can be used to secure the leaflets as described further below. In some embodiments, the anchor 802 can be plastically deformable (e.g., formed from stainless steel). If formed from a plastically deformable material, the anchor 802 can be expanded from the delivery configuration to the leaflet capturing configuration by using a torque shaft (not shown, but similar to torque shaft 220) to rotate bolt 818 to bend the anchor 802 as best shown in FIG. 46 and as described in detail above.

[0109] The spacer body 804 may then be deployed by further retracting the delivery sheath, allowing the spacer body to radially expand and capture the native leaflet 836 between the anchor 802 and the spacer body 804, as shown in FIG. 47. The leaflet 836 may then be securely secured between the anchor 802 and the spacer body 804 by rotating the torque shaft and bolt 818, and by moving the nut 824 and wire 816 proximally along the threaded shaft portion 806. The movement of the wire has the effect of bending the tube 814, further biasing the anchor 802 against the leaflet 836. The prosthetic device 800 may thus be secured to the leaflet 836 by clamping the leaflet between the anchor 802 and the spacer body 804, as shown in FIG. 47. The delivery device may then be removed from the patient's body.

[0110] With the device 800 secured to both leaflets 836, this draws the leaflets 836 closer together around the spacer body 804. In doing so, the device 800 reduces the total area of ​​the mitral valve opening and separates the mitral valve opening into two openings during diastole. Thus, the area over which mitral regurgitation can occur is reduced, leaflet coaptation can be initiated at the body 804, and the leaflets can more easily coapt completely, preventing or minimizing mitral regurgitation.

[0111] 48-52 show another exemplary embodiment of an implantable prosthetic device 1000 similar to device 800. In the illustrated embodiment, device 1000 comprises one or more ventricular anchors 1002 (two in the illustrated embodiment), a spacer body 1004, and an inner shaft assembly (not shown, similar to shaft assembly 806 of device 800). The inner shaft assembly extends coaxially through body 1004. Anchors 1002 press radially inward toward the inner shaft to create a clamping force between anchors 1002 and spacer body 1004 as described further below.

[0112] 49, the spacer body 1004 may comprise a metal frame including a distal first annular collar 1008 disposed about a shaft assembly (not shown) and positioned near the ventricular end of the spacer body 1004, a proximal second annular collar 1010 disposed about the shaft assembly and positioned near the atrial end of the spacer body 1004 of the device 1000, and a plurality of interconnecting struts 1012 extending between the first collar 1008 and the second collar 1010. In some embodiments, the struts 1012 may be fixedly secured to the collars 1008, 1010, for example, by forming the struts 1012 and the collars 1008, 1010 from a single unitary piece of material (e.g., laser cutting a metal tube). In other embodiments, the struts 1012 may be fixedly secured to the collars 1008, 1010, for example, by adhesive, welding, fasteners, etc. Although not shown in Figures 48-52, the spacer body 1004 may be covered with a blood impermeable covering (eg, fabric) or may be covered with a flexible sealant (eg, ePTFE).

[0113] As shown, each of the anchors 1002 of the device 1000 may include a flexible tube portion 1014. The tube 1014 may be formed from alloy tubing, such as, for example, Nitinol, stainless steel, cobalt chrome, etc. A proximal end 1020 (FIG. 52) of the tube 1014 may be securely fastened or bonded to the distal collar 1008, for example, by adhesive, welding, fasteners, etc.

[0114] The tube 1014 may also be configured to bend more easily in a desired direction and / or through a tighter bend radius without plastic deformation (e.g., kinking). For example, as shown, a portion of the circumference of the tube 1014 may be fabricated (e.g., by laser cutting) such that a section of the tube includes a number of ribs 1016 on a first cut side of the tube and a non-opening or spine 1018 on a second, uncut side opposite the cut side about the circumference of the tube. Cutting the tube on one side allows the tube 1014 to bend more easily toward the side of the tube having the ribs 1016 relative to the side having the spine 1018. Also, as best shown in FIG. 52, the tube 1014 may be cut asymmetrically relative to the longitudinal axis of the tube 1014 such that the ribs 1016 are oriented on respective sides of the tube 1014 for respective axial sections. Thus, by cutting the tube 1014 and orienting the ribs 1016, the manner and sequence in which the tube 1014 bends / buckles and extends / straightens can be controlled.

[0115] Although not shown, the inner shaft assembly of device 1000 can be similar to shaft portion 806 of device 800, including including substantially identical components. Also, anchor 1002 can include an anchor wire (not shown, but similar to wire 816) secured at a first proximal end of the wire to a shaft nut (not shown) similar to wire 816, and secured at a second distal end of the wire to a distal end of tube 1014. Thus, device 1000 can function substantially similarly to device 800. However, anchor 1002 of device 1000 can laterally contact the native valve leaflets (not shown).

[0116] The term "lateral" in reference to the device 1000 means approximately perpendicular to a longitudinal axis of the prosthetic device 1000 that extends through the distal collar 1008 and the proximal collar 1010. For example, Figure 49 shows the anchors extending laterally across the spacer body 1004 with their longitudinal axis extending coaxially through the collars 1008, 1010. Thus, in this manner, each anchor 1002 can extend laterally across and in contact with the ventricular side of each native leaflet.

[0117] It should be noted that while the anchors 802, 1002 of each device 800, 1000 can be simultaneously actuated (e.g., moved from a delivery configuration to a functional configuration and / or secured to the native leaflets, etc.) as described above, in some embodiments, each individual anchor can be actuated individually. For example, one of the anchors 802, 1002 can be moved from the delivery configuration to the functional configuration and secured to the native leaflets, and then another anchor 802, 1002 can be moved from the delivery configuration to the functional configuration and secured to the native leaflets.

[0118] To allow the anchors to be individually actuated, a shaft assembly (similar to shaft assembly 806) can include multiple bolts and nuts (similar to bolt 818 and nut 824), for example, each corresponding to a separate pull wire of each anchor. By having a separate bolt and nut for each pull wire, each anchor can be actuated by rotating the bolt corresponding to the anchor, causing the nut to move axially along the threaded portion of the bolt and the anchor to either bend / bend or extend / straighten depending on the direction of rotation of the bolt.

[0119] 53-58 show another exemplary embodiment of an implantable prosthetic device 1100. In the illustrated embodiment, the device 1100 comprises a ventricular portion 1102, a spacer body 1104, an inner shaft 1106, and an outer shaft 1108. The inner shaft 1106 extends coaxially through the outer shaft 1108, and the inner shaft 1106 and the outer shaft 1108 extend coaxially through the spacer body 1104. The outer shaft 1108 can be axially movable (proximally and distally) relative to the inner shaft 1106 and the spacer body 1104. The distal direction is indicated by arrow 1120 (FIG. 53), with the proximal direction being approximately opposite to the distal direction. The spacer body 1104 can be axially movable (proximally and distally) relative to the inner shaft 1106 and the outer shaft 1108.

[0120] The ventricular section 1102 comprises one or more outer anchor members 1110 (two in the illustrated embodiment), one or more inner anchor members 1112 (two in the illustrated embodiment), and one or more cross members 1114 (two in the illustrated embodiment). The outer anchors 1110 may be pivotally coupled (e.g., by a pin, fastener, ball joint, etc.) to a distal end of the inner shaft 1106 at a first distal end of the outer anchor 1110, thereby forming a first pivotable joint 1116. The outer anchors 1110 extend from the first joint 1116 to a second proximal end of the outer anchor 1110. The inner anchors 1112 may be pivotally coupled to each outer anchor 1110 at an intermediate portion of the inner anchor 1112, thereby forming a second pivotable joint 1118. The cross member 1114 may be pivotally coupled at a first, inner end of the cross member 1114 to a distal end of the outer shaft 1108 to form a third pivotable joint 1122. The cross member 1114 may be pivotally coupled at a second end of the cross member 1114 (opposite the first end) to each distal end of the inner anchors 1112 to form a fourth pivotable joint 1124.

[0121] Additionally, cross member 1114 may be slidably coupled to each outer anchor 1110 by a coupling element 1126. As best shown in FIG. 53, coupling element 1126 may be disposed on each outer anchor 1110 between pivotable joint 1116 and pivotable joint 1118, and on cross member 1114 between pivotable joint 1122 and pivotable joint 1124. Coupling element 1126 may be formed in outer anchor 1110, for example, as a slot through which cross member 1114 extends.

[0122] The spacer body 1104 can comprise an annular metal frame (not shown, but similar to frame 28) covered with a blood impermeable fabric 1128. The frame can comprise a mesh-like structure comprising a plurality of interconnected metal struts, or can comprise a metal braid. The frame can be formed from a self-expanding material, such as Nitinol. In other embodiments, the frame can be formed from a plastically expandable material, such as stainless steel or a cobalt chromium alloy.

[0123] Due to the adjustable nature of the ventricular portion 1102 and the flexible nature of the spacer body 1104, the device 1100 can be radially compressed into a delivery configuration (FIG. 54) and held in the delivery configuration by placing the device within a sheath of a delivery apparatus.

[0124] 54-58, the device 1100 can be delivered percutaneously with a delivery device (not shown) to a native heart valve (e.g., the mitral valve), such as by utilizing the transseptal techniques described with respect to the prosthetic device 200 and delivery device 202 (shown in FIGS. 6-8). Although not shown, the delivery device can include a sheath (similar to the sheath 216) into which the prosthetic device 1100 can be loaded, inner and middle shafts removably coupled to the respective inner and outer shafts 1106, 1108 of the device 1100, and an outer shaft removably coupled to the spacer body 1104 of the device 1100.

[0125] The device 1100 and delivery apparatus may be advanced past the native mitral valve leaflets 1130 until the ventricular portion 1102 of the device 1100 is located within the left ventricle (as illustrated in FIG. 55 and similar to the configuration shown in FIG. 6). The ventricular portion 1102 may be exposed from the delivery sheath by distally advancing the inner shaft of the delivery apparatus, and thus the inner shaft 1106 of the device 1100, relative to the sheath of the delivery apparatus and / or by retracting the delivery sheath relative to the inner shaft.

[0126] The anchor 1102 may be expanded from the delivery configuration to the leaflet capture configuration by extending the cross member 1114 laterally and perpendicularly to the inner shaft 1106 (as shown in FIG. 55 ) by distally advancing the outer shaft of the delivery device, and thus the outer shaft 1108, relative to the inner shaft 1106, thus moving the joint 1122 distally (i.e., toward the joint 1116) along the inner shaft 1106. The cross member 1114 causes the outer anchor 1110 to expand radially relative to the inner shaft 1106, and the inner anchor 1112 to expand or open relative to the outer anchor 1110, as shown in FIG. 55 . With the anchors 1110, 1112 expanded and open, the leaflets 1130 may be positioned within the anchors 1110, 1112 (e.g., desirably in the A2 and P2 positions) by proximally retracting the inner shaft 1106, as shown in FIG.

[0127] The leaflets 1130 can then be secured between the anchors 1110, 1112 by further advancing the outer shaft 1108 distally relative to the inner shaft 1106, moving the joint 1122 further distally along the inner shaft 1106 so that it is located distally relative to the joints 1124, 1126. As shown in FIG. 57 , movement of the outer shaft 1108 and cross member 1114 has the effect of pushing the proximal end of the inner anchor 1112 toward the proximal end of the outer anchor 1110 by moving the distal end of the inner anchor 1112 inwardly toward the inner shaft 1106 and pivoting the inner anchor 1112 about the joint 1118.

[0128] FIG. 57 also shows that the spacer body 1104 may then be deployed by retracting the delivery sheath. If formed from a self-expanding material, the frame may self-expand to its functional size (FIGS. 57-58). If formed from a plastically expandable material, the prosthetic device may be folded onto the delivery apparatus and radially expanded to its functional size by an inflatable balloon or equivalent expansion mechanism. The spacer body 1104 may then be positioned by advancing the outer shaft of the delivery apparatus, and thus the spacer body 1104, relative to the inner shaft 1106 and outer shaft 1108 of the device 1100 as shown in FIG. 58. As shown, the spacer body 1104 is only partially expanded, but the spacer body 1104 may be further expanded such that the leaflets contact the spacer body 1104. The shaft of the delivery apparatus may then be unlatched from the device 1100 and retracted into the delivery apparatus sheath. The delivery apparatus may then be removed from the patient's body.

[0129] In some embodiments, as shown, it is possible that each of the cross members 1114 of the device 1100 is coupled to the same outer shaft 1108, such that both anchors can be actuated simultaneously. This configuration can result in a device that is easy to use, for example, because the number of steps performed by a physician to implant the device is relatively small. For example, this can help reduce the complexity and / or time required to perform a placement procedure.

[0130] In some embodiments, each of the cross members 1114 of the device 1100 is coupled to a separate outer shaft, thus allowing the anchors to be actuated individually. This configuration may, for example, allow the physician to more easily capture the native leaflets because the physician is able to capture one side at a time. This may be beneficial due to the dynamic properties of the leaflets, for example, during diastole and systole of the heart. Also, in some embodiments, the spacer body 1104 may be secured to the outer shaft 1108, allowing the spacer body 1104 and the ventricular portion 1102 to be positioned simultaneously, which may, for example, advantageously reduce the time required to perform the placement procedure.

[0131] 59-61 show another exemplary embodiment of an implantable prosthetic device 1200 similar to device 1100. In the illustrated embodiment, device 1200 comprises at least one anchor 1202 (one is shown for illustration purposes, but multiple anchors 1202 may be included), a spacer body (not shown, but similar to spacer body 1104), a shaft 1206, and a sleeve 1208 coaxially and slidably disposed on shaft 1206. Shaft 1206 extends coaxially through spacer body and sleeve 1208. The spacer body is located on shaft 1206 proximally relative to sleeve 1208.

[0132] The sleeve 1208 can be axially movable (proximally and distally) relative to the shaft 1206. The distal direction is indicated by arrow 1204 in FIG. 59, and the proximal direction is opposite to the distal direction. The spacer body can be axially movable (proximally and distally) relative to the shaft 1206. In some embodiments, the spacer body can also be axially movable relative to the sleeve 1208, such that the spacer body can be deployed and / or positioned separately from the anchor 1202. In some embodiments, the spacer body can be secured or coupled to the sleeve 1208, such that it can be deployed and / or positioned simultaneously with the anchor 1202.

[0133] 60, the anchor 1202 can be a truss-like structure including an outer member 1210, an inner member 1212, and a cross member 1214. The outer member 1210 can be pivotally coupled (e.g., by a pin, fastener, etc.) to a distal end of the shaft 1206 at a first distal end of the outer member 1210 to form a first pivotable joint 1216. The outer member 1210 extends from the first joint 1216 to a second proximal end of the outer member 1210. The inner member 1212 can be pivotally coupled to the outer member 1210 near the distal end of the outer member 1210 at a mid-portion of the inner member 1212 to form a second pivotable joint 1218. The cross member 1214 may be pivotally coupled to the sleeve 1208 at a first end thereof to form a third pivotable joint 1220. The cross member 1214 may also be pivotally coupled to a distal end of the inner member 1212 at a second end thereof (opposite the first end) to form a fourth pivotable joint 1222. The outer member 1210 may also include an opening 1224 that allows the inner member 1212 and the cross member 1214 to extend through the outer member 1210 when the device is in the leaflet capturing configuration, as shown in FIG.

[0134] Although not shown, the spacer body can comprise an annular metal frame (similar to frame 28) covered with a blood impermeable fabric (similar to fabric 1128). The frame can comprise a mesh-like structure comprising a plurality of interconnected metal struts or can comprise a metal braid. The frame can be formed from a self-expanding material such as Nitinol. In other embodiments, the frame can be formed from a plastically expandable material such as stainless steel or a cobalt chromium alloy.

[0135] The adjustable nature of the anchors 1202 and the flexible nature of the spacer body allow the device 1200 to be radially compressed into a delivery configuration (FIG. 59). As shown, the cross members 1214 can be configured to fit within the inner member 1212, which in turn can be configured to fit within the outer member 1210, thereby reducing the profile of the device 1200 in the delivery configuration.

[0136] Although not shown, device 1200 may be delivered percutaneously to a native heart valve (e.g., mitral valve) along with a delivery apparatus, such as using the transseptal techniques described with respect to device 1100 (shown in FIGS. 54-58). FIG. 59 shows the device in a delivery configuration (similar to device 1100 of FIG. 54). FIG. 60 shows device 1200 in a leaflet capture configuration (similar to device 1100 of FIGS. 55-56). FIG. 61 shows device 1200 in a functional or leaflet fixation configuration (similar to device 1100 of FIGS. 57-58).

[0137] Delivery Systems and Devices A delivery system and / or delivery apparatus used to percutaneously deliver a prosthetic implant device (e.g., a prosthetic spacer device) may include a guiding sheath, one or more catheters (e.g., an outer catheter, a guide catheter, and / or an implant catheter), and other devices. In general, a guiding sheath may be inserted into a patient's body, providing an access point for introducing other devices (e.g., catheters) into the patient's body. For example, during a transseptal procedure, a guiding sheath may be inserted through the patient's right femoral vein, through which an outer catheter may be inserted. The outer catheter may be advanced through the femoral vein, through the vena cava, and into the right atrium. The septum is then punctured with the outer catheter, so that it extends into the left atrium. The outer catheter may then be retained in the septal opening.

[0138] An intermediate or guide catheter may be threaded through the outer catheter to achieve the desired positioning for each procedure. For example, the guide catheter may be used to achieve positioning relative to the mitral valve. In certain embodiments, the guide catheter may also serve as an implant catheter configured to advance the prosthetic device through the patient's vasculature and deploy the prosthetic device at the desired implantation location. For example, the distal end portion of the guide catheter may include a delivery sheath configured to maintain the prosthetic device in a compressed delivery state while being advanced through the patient's body. In alternative embodiments, an inner or implant catheter may be threaded through the guide catheter to deploy, secure, and remove the prosthetic implant device.

[0139] Some embodiments of the delivery system disclosed herein allow the implant catheter to be preloaded (i.e., threaded through the guide catheter before the guide catheter is advanced through the outer catheter) or loaded during the procedure (i.e., threaded through the guide catheter after the guide catheter is advanced into the left side of the patient's heart). Some embodiments of the delivery system disclosed herein include an intermediate or guide catheter having a flexible steerable distal end and a control member on or adjacent to the handle that can be used to bend, flex, and / or orient the distal portion. Some of the disclosed delivery systems include various locking, rotating, and / or anti-rotational, or binding features.

[0140] The delivery systems disclosed herein can greatly improve the likelihood that catheters used in, for example, transseptal procedures utilized to implant prosthetic implant devices can be oriented and secured as desired by a physician, and these systems can greatly improve the safety, duration, and effectiveness of, for example, prosthetic implant placement procedures.

[0141] 62 illustrates an exemplary steerable flexible artificial implant delivery device 1300 according to one embodiment. In the illustrated embodiment, the delivery device 1300 generally comprises an implant cover or sheath 1302, a flexible radially expandable basket portion 1304, a midshaft 1306, a basket expansion mechanism 1308, a proximal shaft 1310, a steering control member 1312, a plurality of gasket expansion wires 1314 (four in the illustrated embodiment, but only two are shown in FIG. 62), and a plurality of steering control wires 1316 (four in the illustrated embodiment, but only two are shown in FIG. 62).

[0142] The basket portion 1304 of the delivery device 1300 may be disposed between the sheath 1302 and the midshaft 1306. The basket portion 1304 may be securely secured or coupled (e.g., by adhesive, fasteners, etc.) to the sheath 1302 at a first distal end of the basket portion 1304 and securely secured or coupled to the midshaft 1306 at a second proximal end of the basket portion 1304. The expansion mechanism 1308 may be disposed between the midshaft 1306 and the proximal shaft 1310. As described further below, the expansion mechanism 1308 may be coupled to the midshaft 1306 at a first distal end of the expansion mechanism 1308 and to the proximal shaft 1310 at a second proximal end of the expansion mechanism 1308.

[0143] The steering control member 1312 may be disposed proximally on the proximal shaft 1310 relative to the expansion mechanism 1308. The basket expansion wires 1314 may extend coaxially through the sheath 1302, the basket portion 1304, the mid shaft 1306, the basket expansion mechanism 1308, and the proximal shaft 1310. The expansion wires 1314 may be securely fixed (e.g., by adhesive) to the sheath 1302 at a first distal end 1318 of each expansion wire 1314 and to the proximal shaft 1306 at a second proximal end 1320 of each expansion wire 1314.

[0144] The control wires 1316 may extend through the sheath 1302, over the basket portion 1304, and coaxially through the mid shaft 1306, the expansion mechanism 1308, and the proximal shaft 1310. The control wires 1316 may be fixedly secured to the sheath 1302 at a first distal end 1322 of each control wire 1316 and to the control member 1312 at a second proximal end 1324 of each control wire 1316.

[0145] The sheath 1302 of the delivery device 1300 can be configured to receive various prosthetic implant devices and / or hold prosthetic implant devices in a delivery configuration. For example, the sheath 1302 can receive a prosthetic spacer device (e.g., a prosthetic spacer described herein) and hold the prosthetic device in a delivery configuration (as shown in FIG. 67). The sheath 1302 can also receive, for example, a prosthetic heart valve, a stent, etc.

[0146] The basket 1304 of the delivery device 1300 can be expandable such that the basket 1304 can be placed in a non-expanded delivery configuration (best shown in FIG. 63b) so that the device 1300 can have a relatively small profile when space is limited (e.g., when passing through another catheter or container). When space is not limited (e.g., when advanced out of another catheter into the left atrium or another chamber of the heart), the basket 1304 can be radially expanded to a functional configuration (best shown in FIG. 64). The basket 1304 provides flexibility to the distal end portion of the device, thereby providing the physician with greater range of motion and maneuverability at the distal end of the device 1300, and thus greater control of the prosthetic implant device during the implant placement procedure. In certain embodiments, the basket 1304 comprises a mesh or braided structure, such as a polymeric braid (e.g., nylon) or a metallic braid (e.g., nitinol or stainless steel).

[0147] 65A, the midshaft 1306 of the delivery device 1300 may include a centrally disposed (relative to the longitudinal axis of the device) implant or working lumen 1326 and a plurality of wire lumens 1328 (eight in the illustrated embodiment) disposed radially outward from and annularly distributed around the implant lumen 1326 in the sidewall of the shaft. The wire lumens 1328 may be angularly spaced from one another by approximately 45 degrees. Each lumen 1326, 1328 may extend axially through the midshaft 1306.

[0148] The implant lumen 1326 may allow, for example, a device implant catheter (not shown, but similar to the implant catheter 214) to be threaded therethrough. Each of the wires 1314, 1316 may extend through each of the wire lumens 1328. The four extension wires 1314 may occupy four of the wire lumens 1328 in an alternating lumen pattern such that the extension wires 1314 are spaced apart from one another by approximately 90 degrees. The four control wires 1316 may occupy the remaining four unoccupied wire lumens 1328 in an alternating lumen pattern such that the control wires 1316 are spaced apart from one another by approximately 90 degrees.

[0149] 62, the midshaft 1306 may also include a plurality of radially extending side openings or ports 1330 (four in the illustrated embodiment, but only two are shown in FIG. 62) located near the distal end of the midshaft 1306 but proximal to the basket 1304. The ports 1330 may be circumferentially distributed around the midshaft 1306 (e.g., spaced apart from one another by 90 degrees) and configured to correspond to the wire lumens 1328 occupied by the control wires 1316 such that the control wires 1316 may enter each wire lumen 1328 via each side opening 1330. The midshaft 1306 may be formed from a biocompatible polymer, such as a polyether block amide (e.g., Pebax®).

[0150] The midshaft 1306 can include various axial sections with different hardness and / or stiffness. For example, as shown in FIG. 65b, the midshaft can include a first distal section 1332 and a second proximal section 1334. The distal section 1332 of the midshaft 1306 can include a softer material, for example, as compared to the material of the proximal section 1334 of the midshaft 1306. In some embodiments, for example, the sections 1332, 1334 of the midshaft 1306 can include Pebax® having Shore D hardness values ​​of 55 and 72, respectively. A midshaft with a softer distal end can allow, for example, the distal end of the midshaft 1306 to bend and / or flex more easily without twisting or other plastic deformation.

[0151] The basket expansion mechanism 1308 of the delivery device 1300 may include a distal nut 1338, a proximal nut 1340, and an outer nut or sleeve 1342 as shown in FIG. 62. The distal nut 1338 may be secured to the proximal end of the midshaft 1306 and may include external threads oriented in a first direction. The proximal nut 1340 may be secured to the distal end of the proximal shaft 1310 and may include external threads oriented in a second direction. This second direction is opposite to the first direction of the threads of the distal nut 1338. The outer nut 1342 may include a first internal thread 1344 along a distal end portion of the outer nut 1342 that corresponds to and engages with the threads of the distal nut 1338 and a second internal thread 1346 along a proximal end portion of the outer nut 1342 that corresponds to and engages with the threads of the proximal nut 1340.

[0152] Similar to a turnbuckle, in use, by rotating the outer nut 1342 in a first direction relative to the distal nut 1338 and proximal nut 1340, the distal nut 1338 and proximal nut 1340 and thus the mid shaft 1306 and proximal shaft 1310 are moved toward each other, and by rotating the outer nut 1342 in a second direction (opposite the first direction) relative to the distal nut 1338 and proximal nut 1340, the distal nut 1338 and proximal nut 1340 and thus the mid shaft 1306 and proximal shaft 1310 are moved away from each other.

[0153] Additionally, rotating the outer nut 1342 in a first direction relative to the distal nut 1338 and the proximal nut 1340 moves the mid shaft 1306 proximally toward the proximal shaft 1310, thereby moving the mid shaft 1306 proximally away from the sheath 1302. Additionally, rotating the outer nut 1342 in a second direction relative to the distal nut 1338 and the proximal nut 1340 moves the mid shaft 1306 distally away from the proximal shaft 1310, thereby moving the mid shaft 1306 distally toward the sheath 1302.

[0154] Due to the flexible properties of the basket 1304, by rotating the outer nut 1342 in a first direction relative to the distal and proximal nuts 1338, 1340 (i.e., by moving the mid-shaft 1306 in a proximal direction away from the sheath 1302), the basket 1304 is axially extended and radially compressed to the delivery configuration (shown in FIG. 63b). By rotating the outer nut 1342 in a second direction relative to the distal and proximal nuts 1338, 1340 (i.e., by moving the mid-shaft 1306 in a distal direction towards the sheath 1302), the basket is axially shortened and radially expanded to the functional configuration (shown in FIGS. 62, 64, 67).

[0155] The proximal shaft 1310 of the delivery device 1300 may have a structure substantially similar to that of the midshaft 1306, with a centrally disposed (relative to the longitudinal axis) implant lumen 1348 (shown in FIG. 66) and a number of wire lumens (not shown, but similar to the wire lumen 1328) (eight in the illustrated embodiment) disposed radially outward from and circumferentially distributed around the implant lumen 1348 in the sidewall of the shaft 1310. The implant and wire lumens may extend coaxially through the proximal shaft 1310. The implant and wire lumens of the proximal shaft 1310 and the midshaft may be configured to be axially aligned such that the wires 1314, 1316 may extend axially through the shafts 1306, 1310.

[0156] 62, the proximal shaft 1310 may include a plurality of radially extending side openings or ports 1350 (four in the illustrated embodiment, but only two are shown in FIG. 62) in communication with the lumen 1328 that contacts the control wire 1316. The side openings 1350 may be radially aligned with the ports 1330 of the midshaft 1306. The ports 1350 of the proximal shaft 1310 may be disposed on the proximal shaft 1310 between the proximal nut 1340 of the basket expansion mechanism 1308 and the control member 1312 such that the control wire 1316 may exit the unrelated wire lumen 1328 of the proximal shaft 1310 via each side opening 1350. The proximal shaft 1310 may be formed from a biocompatible polymer. For example, the proximal shaft 1310 may include Pebax having a Shore D hardness value of 72.

[0157] The steering control member 1312 of the delivery device 1300 may include a pivotable control handle 1352 and a fixed sleeve portion 1354. The sleeve portion 1354 may be disposed proximally on the proximal shaft 1310 and fixedly secured to the side port 1350 of the proximal shaft 1310. The sleeve portion may include a spherical or at least partially spherical outer surface 1356. The control handle 1352 may include a socket portion 1358 ( FIG. 62 ) disposed about the outer surface 1356 of the sleeve 1354. In this manner, the outer surface 1356 acts as a ball joint formed with the socket portion 1358. The socket 1358, and thus the control handle 1352, may be pivotable relative to the ball 1356.

[0158] The control handle 1352 can also include a number of axially extending apertures 1360 (four in the illustrated embodiment, see FIG. 66 ) disposed radially outward on the control handle 1352 relative to the socket 1358 and configured to receive the proximal end 1324 of each control wire 1316, thereby securing the proximal end 1324 of the control wire 1316 to the handle 1352. The apertures 1360 can be angularly spaced apart from one another around the circumference of the handle 1352, such as by about 90 degrees.

[0159] In some embodiments, as shown, the proximal end 1324 of each control wire 1316 may be secured to the handle 1352 by threading the proximal end 1324 of the wire 1316 through a respective aperture 1360 and attaching a respective end cap or ferrule 1362 to the proximal end 1324 of each control wire 1316. The end cap or ferrule 1362 has a diameter greater than the diameter of the aperture 1360, thereby preventing the proximal end 1324 of the control wire 1316 from backing out through the aperture 1360. In other embodiments, the proximal end 1324 of the control wire 1316 may be secured within the aperture 1360 and thus to the handle 1352, for example, by an adhesive. In some embodiments, the handle 1352 may be formed from a polymeric material such as acetal (e.g., Delrin®). In some embodiments, the sleeve 1354 may be formed from a polymeric material such as polycarbonate.

[0160] The ends 1318, 1320 of the expansion wires 1314 of the device 1300 may be fixedly secured to the sheath 1302 and the proximal shaft 1310, respectively. Desirably, the wires 1314 are evenly spaced from one another around the longitudinal axis of the device, such as by 90 degrees. Also, each of the expansion wires 1314 may have substantially the same axial length and may be pulled evenly. Having the expansion wires 1314 evenly distributed circumferentially and providing substantially uniform tension to the expansion wires 1314 may enable the sheath 1302, mid shaft 1306, and proximal shaft 1310 to maintain axial alignment as the basket 1304 expands upon adjustment of the basket expansion mechanism 1308, as described above.

[0161] Similarly, both ends 1322, 1324 of the control wires 1316 of the device 1300 may be fixedly secured to the sheath 1302 and the handle 1352, respectively. The control wires 1316 are desirably evenly spaced from one another about the longitudinal axis of the device, such as by 90 degrees. Also, the control wires 1316 may each have substantially the same axial length and may be equally tensioned. The length of the control wires 1316 may be selected such that they have slack when the basket 1304 is in the axially elongated delivery configuration (FIG. 63b) and may be taut when the basket 1304 is in the radially expanded functional configuration.

[0162] Having the control wires 1316 evenly distributed circumferentially and providing a substantially uniform tension on the control wires 1316 may allow for multi-directional control of the sheath 1302 and thus the implant device, for example, by pivoting the handle 1352 (e.g., forward, backward, and / or sideways) about the ball 1356. For example, with reference to FIG. 62, pivoting the handle 1352 such that an upper portion of the handle 1352 moves proximally (i.e., in the direction of arrow 1374) has the effect of pulling the proximal end 1324 of the upper control wires 1316 proximally, which in turn causes the sheath 1302 to be pivoted upward relative to the midshaft 1306 in the direction of the arrow 1376. To move the distal end of the sheath 1302 downward, the physician can pivot the handle 1352 of the control member 1312 such that a lower portion of the handle 1352 moves proximally, which has the effect of pulling the proximal end 1324 of the lower control wire 1316 proximally, which in turn pivots the distal end of the sheath 1302 downward relative to the intermediate shaft 1306 in the direction of the arrow 1378.

[0163] The delivery device 1300 may be used, for example, to deliver a prosthetic implant percutaneously. For example, FIG. 67 shows the delivery device 1300 being used to deliver a prosthetic spacer device 1364 into the mitral valve 1366 of a heart 1368. With the prosthetic implant device preloaded into the sheath 1302, the delivery device 1300 may be advanced through the outer catheter 1370 into the left atrium 1371 of the heart 1368. With the sheath 1302, basket 1304, and midshaft 1306 of the device 1300 located in the left atrium, the basket 1304 may be expanded into a functional configuration by rotating the outer nut 1342 of the basket expander 1308 to move the midshaft 1306 toward the sheath (described in more detail above). Expanding the basket 1304 of the device 1300 places the control wires 1316 in a taut state, which then allows the physician to orient the prosthetic spacer device 1364 as desired by pivoting the handle 1352 of the control member 1312. For example, the physician can rotate the sheath 1302 90 degrees relative to the outer catheter 1370 to align the prosthetic spacer device 1364 with the patient's mitral valve 1366.

[0164] Once the prosthetic device 1364 is desirably oriented, it may be advanced out of the sheath 1302 of the device 1300 and then secured to the native leaflets 1372 of the mitral valve 1366 as previously described in connection with the prosthetic spacer devices described herein. The basket 1304 may then be radially compressed back to the delivery configuration by actuating the basket expansion mechanism 1308, thus allowing the delivery device 1300 to be retracted into the outer catheter 1370 and removed from the patient.

[0165] The implant lumens 1348, 1326 of the shafts 1310, 1306 (respectively) advantageously allow the physician to introduce additional catheters (e.g., implant catheters) during the procedure without having to withdraw the delivery device from the patient. These additional catheters introduced through the implant lumens 1348, 1326 can be used, for example, to deploy prosthetic spacer devices.

[0166] 68 illustrates an exemplary steerable prosthetic implant delivery device 1400 according to another embodiment. The delivery device 1400 may include a flexible inner shaft 1402, a middle shaft 1404, a slidable outer shaft 1406, a steering control member 1408, a wire puller 1410, a plurality of pivoting control wires (not shown, but similar to wires 1316), and a hemostatic seal 1412 (e.g., a tapered luer fitting). The inner shaft 1402, middle shaft 1404, and outer shaft 1406 may extend coaxially through the control member 1408 and the puller 1410, respectively. The inner shaft 1402 and middle shaft 1404 may extend coaxially through the outer shaft 1406, and the inner shaft 1402 may extend coaxially through the middle shaft 1404. The inner shaft 1402 may be fixedly secured (e.g., with an adhesive) to the mid-shaft 1404. The outer shaft 1406 is disposed about the mid-shaft 1404 and may be axially movable (i.e., distally and proximally) relative to the mid-shaft 1404.

[0167] The control member 1408 of the delivery device 1400 may include a ball 1414, a handle 1416, and a ring 1418 (FIG. 69). The ball 1414 may be disposed about the distal end of the outer shaft 1406 and may be securely secured thereto (e.g., with an adhesive). The handle 1416 may be disposed about the ball 1414 and may be pivotally coupled thereto. The ring 1418 may be disposed in an annular notch or groove 1420 formed in an outer surface of the handle 1416.

[0168] The plurality of pivot control wires (not shown) of the delivery device 1400 may comprise, for example, four pivot control wires similar to the control wire 1316. These control wires may have a first distal end firmly fixed or attached to the distal end 1456 of the inner shaft 1402 and a second proximal end firmly fixed or attached to the ring 1418 and thus to the handle 1416. The control wires may be spaced 90 degrees from each other, similar to the control wire 1316 described above in connection with the sheath 1302 and the control wire 1352 (FIGS. 62, 66), and may be distributed annularly around the central axes of the inner shaft 1402 and the handle 1416. The control wires may extend proximally through each lumen of the inner shaft 1402 and distally through each exit port (not shown) of the inner shaft 1402 and the outer shaft 1404, and the proximal ends of the control wires may be attached to the ring 1418. The ports of the inner shaft 1402 may be oriented to be circumferentially aligned with each port of the intermediate shaft 1404.

[0169] By means of the control member 1408 and the pivot control wires, for example, a physician may be able to control the distal end 1456 of the flexible tube 1402 by pivoting the handle 1416 with respect to the ball 1414 in a manner similar to that described above with respect to the delivery device 1300. Sometimes, during use, the control wires may become slack, for example, by pivoting the handle 1416 into an extreme orientation, which may reduce the effect of the handle 1416 on controlling the distal end 1456 of the flexible tube 1402. To mitigate and / or eliminate this problem, the delivery device 1400 may comprise, for example, a tensioning device 1410 for removing unwanted slack in the control wires, as further described below.

[0170] The tensioning apparatus 1410 of the delivery device 1400 may include a nut guide adapter 1422, a drive nut 1424, a stop washer 1426, a wire tension adjustment knob 1428, an adjustment nut washer 1430, and an end cap 1432. The guide nut 1422 may be fixedly secured to a proximal end of the outer shaft 1406. The guide nut 1422 may include male threads (not shown) that may be configured to engage corresponding female threads (not shown) of the drive nut 1424. The drive nut 1424 may also include male threads (not shown) that correspond and engage with the female threads (not shown) of the wire tension adjustment knob 1428.

[0171] The adjustment knob 1428 can be coupled to and rotatable relative to the end cap 1432. The end cap 1432 can be fixedly secured or coupled to the proximal ends of the inner shaft 1402 and the mid-shaft 1404. In this manner, rotation of the adjustment knob 1428 relative to the guide nut 1422 and the drive nut 1424 in a first direction causes the nuts 1422, 1424 and thus the outer shaft 1406, ball 1414, and handle 1416 to move proximally relative to the inner shaft 1402 and the mid-shaft 1404. Rotation of the adjustment knob 1428 relative to the nuts 1422, 1424 in a second direction (opposite the first direction) causes the nuts 1422, 1424 and thus the outer shaft 1406, ball 1414, and handle 1416 to move distally relative to the shafts 1402, 1404. Thus, with the control wires secured to the sheath at their distal ends and to the handle 1416 at their proximal ends, rotating the adjustment knob 1428 in a first direction applies tension to the control wires and relieves slack in the control wires. It is noted that the tensioning device 1410 may be used in a variety of delivery devices, including, for example, the delivery device 1300.

[0172] The inner shaft 1402 of the device 1400 may comprise a slotted metal tube 1438 as shown in Figures 70a-71b. The metal tube 1438 may be formed, for example, by laser cutting a metal alloy tube (e.g., Nitinol, stainless steel, cobalt chrome, etc.). As best shown in Figure 71b, the tube 1438 may comprise a number of spine sections 1440 and a number of struts 1442 disposed between and interconnecting the spine sections 1440. The tube 1438 may also comprise an annular collar 1444 disposed at a distal end of the tube 1438.

[0173] The tube 1438 may be coated both externally and internally with a flexible polymer coating. The spine portion 1440 of the tube 1438 may include openings 1446 (FIG. 71b), which may allow, for example, the polymer coating to be evenly distributed throughout the tube 1438, thereby providing the inner shaft 1402 with a desirably uniform wall thickness.

[0174] The tube 1438 may be configured to form axially extending rows 1454 with spine portions 1440 separated by struts 1442. For example, in the illustrated embodiment (best shown in FIG. 71b), the spine portions 1440 are arranged into four axially extending rows 1454a, 1454b, 1454c, 1454d (in FIGS. 70b and 71b, for illustration purposes, row 1454d is axially cut down the center to show the tube 1438 in a flattened configuration). The rows 1454a-1454d are angularly spaced apart from one another (e.g., by 90 degrees), and the rows 1454 may be configured such that the spine portions 1440 of a row 1454 are axially offset relative to the spine portions 1440 of radially adjacent rows 1454. Configuring tube 1438 in this manner allows tube 1438 to flex or bend more uniformly in all directions, reducing kinking when compared to a solid tube or a tube having a single solid spine portion.

[0175] The collar 1444 of the tube 1438 includes distally extending tabs 1446 (two in the illustrated embodiment). In embodiments where the control wires are not directly secured or attached to the distal end 1456 of the flexible shaft 1402, but are instead attached to a separate pull ring (not shown), the tabs 1446 may be used to orient the tube 1438 with the pull ring. The pull ring may be attached to the distal end 1456 of the flexible shaft 1402, such as by inserting the tabs 1446 into the pull ring. In such embodiments, the collar 1444 of the tube 1438 may also include radially extending sliding notches or ports 1436 (four in the illustrated embodiment), which may be used, for example, to allow the control wires to enter the tube 1438 and pass through the inner diameter of the flexible tube 1402.

[0176] Additionally, the tube 1438 of the inner shaft 1402 may include various axial sections 1448, 1450, 1452 (three in the illustrated embodiment), as best shown in FIGS. 70a-b. These various axial sections 1448, 1450, 1452 may include, for example, individually sized struts 1442. By providing individually sized struts 1442 (i.e., removing more or less material), the various axial sections may be able to have smaller or larger bend radii. For example, the distal section 1448 may include the thinnest struts (i.e., the most material removed) compared to the more proximal sections 1450, 1452, thereby allowing the distal section 1448 to have the smallest bend radius compared to the more proximal sections 1450, 1452. Additionally, the mid section 1450 may include thinner struts than the proximal section 1452, thereby allowing the mid section 1450 to have a smaller bend radius than the proximal section. It should be noted that although the illustrated embodiment shows the smallest struts located distally and the largest struts located proximally relative to the other sections, these axial sections may be arranged in any order or combination to achieve the desired outcome for a particular application.

[0177] 72-74 show an exemplary embodiment of a control member 1500 that is similar to the control members 1312, 1408 of the delivery devices 1300, 1400, respectively. In the illustrated embodiment, the control member 1500 comprises a ball 1502, a socket 1504, and at least one clip 1506 (two in the illustrated embodiment). The socket 1504 may comprise a first socket portion 1504a and a second socket portion 1504b. The socket portions 1504a, 1504b may be radially separated by the clip 1506. The ball 1502 may comprise an internal opening or lumen 1522 that may allow other devices (e.g., catheter tubes, etc.) to pass through the ball 1502. The socket 1504 may be disposed around the ball 1502 (similar to a ball and socket joint) such that the socket is rotatable relative to the ball.

[0178] The socket portions 1504a, 1504b may include at least one radially extending notch or recessed portion 1508 (two in the illustrated embodiment) (FIG. 73) configured to receive a respective clip 1506. Each recessed portion 1508 may accommodate a respective protrusion 1510. The clips 1506 may be positioned within the recessed portions 1508. Each clip 1506 may include a ball contact surface 1512, a groove or slot 1514 (FIGS. 73-74), and a tab 1516.

[0179] The control member 1500 can further include a fixing mechanism 1526 (FIG. 74) that extends annularly around the socket portions 1504a, 1504b and the clip 1506. This fixing mechanism 1526 holds the socket portions 1504a, 1504b and the clip 1506 together and presses the socket portions 1504a, 1504b and the clip 1506 inward in the radial direction with respect to the ball 1504. The fixing mechanism 1526 can be, for example, one or more biasing elements (such as O-rings or elastic bands) disposed within the respective grooves 1518, 1520 of the socket portions 1504a, 1504b and the clip 1506. In another embodiment, the fixing mechanism can be, for example, a spring force applying mechanism or any other force applying mechanism.

[0180] The ball contact surface 1512 can be configured to press against the outer surface of the ball 1502 and apply a frictional force thereto so that the movement of the socket 1504 relative to the ball 1502 is restricted when manual pressure is removed from the socket 1504 and the clip 1506. The groove 1514 of the clip 1506 can be positioned to abut against the protrusion 1510, whereby the clip 1506 can pivot around the protrusion 1510 with the protrusion 1510 acting as a fulcrum. The clip 1506 can be pivoted by clamping or pinching the tabs 1516 together (in the direction of arrow 1528 in FIG. 74), so that the tabs 1516 can be moved radially inward. By pivoting the clip 1506 in this way, the ball contact surface 1512 is moved radially outward away from the outer surface of the ball 1502, whereby the socket 1504 and the clip 1506 can be rotated relative to the ball 1502. By releasing the manual pressure from the tabs 1516, the clip 1506 can move back into contact with the ball under the biasing force of the fixing mechanism 1526.

[0181] Thus, the clip 1506 of the control member 1500 may function as a locking mechanism to secure the control member 1500 in a desired orientation. For example, if the control member 1500 is used as part of a delivery device (e.g., delivery devices 1300, 1400), the physician may squeeze the tab 1516 of the clip 1506 and pivot the socket portion 1504 (relative to the ball 1502) to pull the control wire (e.g., control wire 1316) and thus the sheath (e.g., sheath 1302) (as described above) into a desired orientation. The physician may then release the tab 1516, which causes the ball contact surface 1512 of the clip 1506 to press against the ball 1502, restricting movement of the socket portion 1504 relative to the ball 1502, thereby holding the sheath in the desired orientation, thereby locking the socket portion 1504 and thus the sheath in the desired orientation. Advantageously, this allows, for example, a physician to orient the delivery device into a desired configuration with one hand, then release that hand from the delivery device and then use both hands to perform another task (e.g., deploying an artificial implant with an implant catheter).

[0182] 75 shows another exemplary embodiment of a control member 1600 similar to control member 1500, including a ball 1602, a socket 1604, and a clip 1606. The ball 1602 may include an internal opening or lumen 1620 that may allow the ball to be mounted onto a shaft of a delivery device. The socket 1604 may include a recessed portion 1608 configured to receive the clip 1606, which in turn accommodates a rod or shaft 1610. The clips 1606 each include a ball contact surface 1612, a groove or slot 1614, and a tab 1616.

[0183] The socket 1604 may further include a groove (not shown but similar to groove 1518) and the clip 1606 may further include groove 1618. The grooves in the socket 1604 and clip 1606 (i.e., groove 1618) may be configured to receive a locking mechanism (e.g., an O-ring, a spring, etc.) to hold the socket 1604 and clip 1606 together and against the ball 1602. The control device 1600 may function substantially similarly to the control member 1500, as described above. As a result, the control member 1600 may provide similar locking type features and advantages, for example, as described in connection with the control member 1500.

[0184] 76-79 show an example embodiment of a control member 1700, similar to control member 1600, that includes a ball 1702, a socket portion 1704, and a clip 1706. The illustrated embodiment, like control member 1600, can be "unlocked" (i.e., socket portion 1704 is allowed to rotate relative to ball 1702) and "locked" (i.e., socket portion 1704 is prevented from rotating relative to ball 1702).

[0185] The ball 1702 of the control member 1700 may include a number of pins or protrusions 1708 (four in the illustrated embodiment) disposed on an outer surface of the ball 1702 and extending radially outward therefrom. The socket portion 1704 may include an axially extending concave portion 1710 (two in the illustrated embodiment) (FIGS. 78-79) and a guide rail 1712 disposed within the concave portion, the guide rail 1712 dividing the concave portion 1710 into two tracks or channels 1714 (FIGS. 78-79). The channel 1714 may be configured such that the socket 1704 slides around the ball 1702, thereby allowing the protrusions 1708 of the ball 1702 to move axially within the socket 1704.

[0186] However, by positioning the protrusions 1708 of the ball 1702 within the guide rails 1712 of the socket 1704, the socket 1704 is unable to rotate circularly relative to the ball 1702. Advantageously, this anti-rotation feature of the control member 1700 prevents, for example, a physician from rotating the socket 1704 and thus twisting the control wires (not shown). These features may, for example, make operation of the control member 1700 and thus the delivery device easier, since only the socket 1704 may move in an intended manner. Also, advantageously, this anti-rotation feature may reduce the likelihood that a physician may inadvertently damage the control member 1700 and / or delivery device, for example, by using the control member in an unintended manner.

[0187] 80-82 show an example embodiment of a control member 1800, similar to control member 1600, that includes a ball 1802, a socket portion 1804, and a clip 1806. The illustrated embodiment, like control member 1600, can be "unlocked" (i.e., socket portion 1804 is allowed to rotate relative to ball 1802) and "locked" (i.e., socket portion 1804 is prevented from rotating relative to ball 1802).

[0188] The ball 1802 of the control member 1800 may include a number of pins or protrusions 1808 (two in the illustrated embodiment) disposed on an outer surface of the ball 1802 and extending radially outward therefrom. The socket portion 1804 may include an axially extending recess or channel 1810 (two in the illustrated embodiment) configured to receive the protrusions 1808 such that the socket 1804 may pivot about the ball 1802, thereby allowing the protrusions 1808 to move axially within the socket 1804. However, by positioning the protrusions 1808 within the channels 1810, the socket portion 1804 is annularly non-rotatable relative to the ball 1802. This anti-rotation feature may provide at least the advantages described in connection with the control member 1700, for example.

[0189] 83-85 illustrate an exemplary control member 1900 according to one embodiment. The control member 1900 may function substantially similarly to the control member 1408 of the device 1400, for example. In the illustrated embodiment, the control member 1900 comprises a ball 1902, a socket portion 1904, and a lock 1906. The socket 1904 may comprise a generally spherically shaped surface (not shown) disposed about the ball 1902 (similar to a ball and socket joint), an externally threaded portion 1908 at a proximal end of the socket 1904, and a flange or handle portion 1910 extending radially from a distal end of the externally threaded portion 1908, as best shown in FIG.

[0190] The lock 1906 may include a generally spherically shaped inner surface 1912 having female threads configured to receive the male threaded portion 1908 of the socket 1904, and a knob 1914 disposed radially outward from the surface 1912. In this manner, rotation of the knob 1914, and thus the lock 1906, relative to the ball 1902 and socket 1904 in a first direction causes the socket 1904 and lock 1906 to move axially toward one another and biases the surface 1912 of the lock 1906 against the ball 1902, thereby preventing the socket 1904 from pivoting or rotating relative to the ball 1902 (i.e., the socket 1904 is "locked"). Additionally, rotation of knob 1914 in a second direction (the second direction being opposite to the first direction) causes socket 1904 and lock 1906 to move axially away from one another, moving surface 1912 of lock 1906 from ball 1902, thereby allowing socket 1904 to pivot or rotate relative to ball 1902 (i.e., socket 1904 is "unlocked").

[0191] 86-87 show an exemplary catheter position locking device 2000 according to one embodiment. In the illustrated embodiment, the locking device 2000 comprises a coupler or sleeve 2002 (best shown in FIG. 87), a housing 2004, and a clasp portion 2006. As best shown in FIG. 87, the sleeve 2002 may extend coaxially over a distal shaft portion 2005 of the housing 2004. The housing 2004 may comprise an axially extending lumen 2008 and a radial opening (not shown), which is approximately perpendicular to the lumen 2008 and comprises female threads. The clasp 2006 may comprise an externally threaded plug 2010 that engages the female threads of the radial opening of the housing 2004 and may extend through the radial opening into the lumen of the housing. The fastener 2006 may also include a head portion or knob 2012 secured to the upper end portion of the plug 2010 .

[0192] In use, rotation of the head 2012, and therefore the plug 2010, in a first direction relative to the housing 2004 moves the plug 2010 radially inward, thereby blocking the lumen 2008 of the housing 2004, and rotation of the head 2012 of the fastener 2006 in a second direction (the second direction being opposite to the first direction) relative to the housing 2004 moves the plug 2010 radially outward, thereby displacing the plug 2010 from the lumen 2008 of the housing 2004.

[0193] The device 2000 may be used, for example, to allow one catheter or sheath to be desirably positioned relative to another catheter or sheath and then secured in the desired position. For example, FIG. 87 shows the device 2000 being used with a guiding sheath 2014 and an outer catheter 2016. In some embodiments, as shown, the device 2000 may be securely secured or coupled to the proximal end of the guiding sheath 2014 by advancing the distal end of the sleeve 2002 of the device 2000 over the sheath 2014. In other embodiments, the device 2000 may be securely secured or coupled to the proximal end of the guiding sheath by adhesives, fasteners, or the like.

[0194] With the axial opening 2008 of the device 2000 unobstructed or open (i.e., the plug 2010 of the catch 2006 is not blocking the axial opening 2008), the outer catheter 2016 may be advanced through the device 2000 and the guiding sheath 2014. In this open or non-occluding configuration, the outer catheter 2016 may be rotated and / or moved axially (i.e., distally or proximally) relative to the device 2000 and thus the guiding sheath 2014 to position the outer catheter 2016 as desired. Once the outer catheter 2016 is positioned as desired, it may be fixed in the desired position by rotating the head 2012 of the catch 2006 in a first direction to move the plug 2010 inwardly and compress against the outer catheter 2016 (as best shown in FIG. 86 ), thereby preventing the outer catheter from rotating and / or moving axially relative to the guiding sheath 2014. Thus, device 2000 can advantageously make procedures significantly safer and easier to perform, for example, by allowing a physician to both adjust and secure the catheter during the procedure.

[0195] 88-91 illustrate an exemplary catheter position locking device 2100 according to another embodiment. In the illustrated embodiment, the locking device 2100 comprises a fixed portion 2102 and a movable portion 2104 coupled to the fixed portion 2102, the movable portion 2104 being rotatable relative to the fixed portion 2102. The fixed portion 2102 of the device may comprise a centrally disposed opening 2106, an axially extending sleeve 2108 disposed radially outward from the opening 2106, and a circumferentially extending notch or groove 2110 disposed radially outward from the sleeve 2108. The movable portion 2104 may comprise a centrally disposed opening 2112 and an axially extending pin 2114 disposed radially outward from the opening 2112. The pin 2114 of the movable portion 2104 may be configured to extend axially through each groove 2110 of the fixed portion, as best shown in FIG.

[0196] It should be noted that although the openings 2106, 2112 are illustrated as having a generally square cross-section, they may comprise a variety of other shapes.

[0197] 90-91, the apertures 2106, 2112 of each portion 2102, 2104 may be configured such that rotating the moveable portion 2104 to a first unlocked position relative to the fixed portion 2102 aligns the aperture 2112 of the moveable portion 2104 with the aperture 2106 of the fixed portion 2102 (FIG. 90). Rotating the moveable portion 2104 to a second locked position relative to the fixed portion 2102 brings the aperture 2112 of the moveable portion 2104 into misalignment with the aperture 2106 such that the moveable portion 2104 interferes with or partially blocks the aperture 2106 of the fixed portion 2102 (FIG. 91).

[0198] Although not shown, device 2100 can be used with a guiding sheath and an outer catheter similar to, for example, sheath 2014 and catheter 2016. Sleeve 2108 of the fixed portion 2102 of device 2100 can be firmly fixed or coupled (e.g., with an adhesive, a fastener, etc.) to the proximal end of the guiding sheath. In a state where the movable part is rotated to the first alignment position, the outer catheter can be advanced through device 2100 and the guiding sheath. In a state where the movable part 2104 is in the alignment position, the outer catheter can be rotated and / or axially moved to a desired position relative to device 2100 and the guiding sheath. When positioned as desired, the movable part 2104 is rotated to a second misalignment position to compress the movable part 2104 against the outer catheter, whereby the outer catheter can be prevented from rotating and / or axially moving relative to the guiding sheath.

[0199] Figures 92 - 96 show an exemplary catheter position locking device 2200 according to another embodiment. In the illustrated embodiment, the locking device 2200 includes a shaft portion 2202, a cam portion 2204, and a handle portion 2206 with a rotatable knob. As best shown in FIG. 93, the shaft 2202 of device 2200 can include an opening or lumen 2208 that axially extends through the shaft 2202 and a flange portion 2210 at the proximal end of the shaft 2202. Also, FIG. 93 shows the shaft portion 2202, and the cam portion 2204 can be coupled by inserting the flange portion 2210 into an annular concave portion 2212 formed at the distal end of the cam portion 2204.

[0200] The cam portion 2204 may be rotatable relative to the shaft portion 2202. The cam 2204 may further include an annular notch or groove 2214 (FIGS. 92-93) disposed near a proximal end of the cam 2204 and an offset opening 2216 (i.e., having an offset or different axis relative to the lumen 2208 of the shaft 2202) (best shown in FIG. 94). The handle portion 2206 may include an opening 2218 extending axially through the handle 2206. The handle portion 2206 may be disposed about and attached to the cam 2204 by passing a fastener (not shown, e.g., a screw or bolt) through a corresponding radially extending internally threaded portion 2220 of the handle 2206. The catch and port 2220 can be configured such that the catch extends through the handle 2206 and engages the cam 2204 in the groove 2214, thereby fixing the handle 2206 relative to the cam 2204. Thus, rotating the handle 2206 rotates the cam 2204.

[0201] The offset opening 2216 allows the handle 2206, and therefore the cam 2204, to be rotated relative to the shaft 2202 into a first unlocked position in which the opening 2216 in the cam 2204 is aligned with the lumen 2208 of the shaft 2202 (FIG. 95), and into a second locked position in which the opening 2216 in the cam 2204 is misaligned with the lumen 2208 of the shaft 2202 such that the cam 2204 interferes with or blocks the lumen 2208 of the shaft 2202 (FIG. 96).

[0202] Although not shown, the device 2200 may be used with a guiding sheath and an outer catheter, as well as a sheath 2014 and catheter 2016, as shown, for example, in FIG. 87. The shaft 2202 may be securely secured or coupled (e.g., with adhesive, fasteners, etc.) to the proximal end of the guiding sheath. With the opening 2216 of the cam 2204 aligned with the lumen 2208 of the shaft 2202, the outer catheter may be advanced through the device 2200 and guiding sheath. In this aligned configuration, the outer catheter may be rotated and / or moved axially relative to the device 2200 and guiding sheath to a desired position. Once positioned as desired, the handle 2200 may be rotated to a second misaligned position to compress the cam 2204 against the outer catheter, thereby preventing the outer catheter from rotating and / or moving axially relative to the guiding sheath.

[0203] 97-98 illustrate an exemplary catheter position locking device 2300 according to another embodiment. The device 2300 comprises a locking sleeve 2302 and a key shaft or tube 2304. As best shown in FIG. 98, the locking sleeve 2302 comprises an axially extending opening 2306 comprising at least one tab or pin 2308 (two in the illustrated embodiment) extending radially inwardly into the opening 2306. The key tube 2304 comprises at least one groove or notch 2310 (two in the illustrated embodiment). The notch 2310 in the key tube 2304 may be configured to correspond to the pin 2308 in the locking sleeve 2302 such that the key tube 2304 may be inserted and moved axially within the opening in the locking sleeve 2302 by aligning the notch in the key tube 2304 with the pin 2308 in the locking sleeve 2302.

[0204] As shown, the pin 2308 of the lock sleeve 2302 and the corresponding notch 2310 of the key tube 2304 can be symmetrically arranged around the opening 2306 of the lock sleeve 2302 and the key tube 2304, respectively. When configured symmetrically, the key tube 2304 can be inserted into the lock sleeve 2302 in a plurality of orientations (two orientations in the illustrated embodiment). Although not shown, it should be noted that the pin 2308 of the lock sleeve 2302 and the corresponding notch 2310 of the key tube 2304 can be arranged asymmetrically around the opening 2306 of the lock sleeve 2302 and the key tube 2304, respectively, such that the key tube 2304 can be inserted into the lock sleeve 2302 in only one orientation.

[0205] The device 2300 can be used with an artificial implant delivery system or device, for example, to prevent one catheter from rotating relative to another catheter. For example, the device 2300 can be used to prevent the intermediate catheter or guide catheter 2312 from rotating relative to an outer catheter (not shown but similar to the outer catheter 2016). The lock sleeve 2302 can be firmly fixed to the proximal end of the outer catheter. For example, the distal end of the lock sleeve 2302 is advanced over the proximal end of the outer catheter, and the lock sleeve 2302 can be firmly fixed to the outer catheter with an adhesive, fastener, etc. The key tube 2304 can be firmly fixed to the shaft of the guide catheter 2312.

[0206] With the locking sleeve 2302 and key tube 2304 secured to the outer catheter and guide catheter 2312, respectively, the guide catheter 2312 may be advanced through the outer catheter until the key tube 2304 enters the locking sleeve 2302. In this configuration, the pin 2308 of the locking sleeve 2302 engages the notch 2310 of the key tube 2304, thereby preventing the guide catheter 2312 from rotating relative to the outer catheter or vice versa. Alternatively, in other embodiments, using the delivery device 1300 as an example, the key tube 2304 may be secured to and disposed on the midshaft between the basket 1304 and the basket expander 1308, preferably near the basket expander 1308. In another implementation, using the delivery device 1400 as an example, the key tube 2304 may be secured to and disposed on the midshaft 1404 distal to but preferably near the control member 1408.

[0207] By preventing rotation of the guide catheter, the delivery system may be significantly safer to use, for example, as this helps prevent accidentally rotating the guide catheter during a procedure. This may make the delivery device significantly easier to use, as improper movements are desirably prevented or eliminated, reducing the number of steps and unnecessary movements required to perform a procedure. Additionally, by joining the key tube to a preset position and / or orientation on the shaft of the guide catheter, the need for the physician to determine how far to advance and / or how to orient the guide catheter relative to the outer catheter may be reduced, making the device 2300 easier to use, shortening procedure times, and / or reducing failures.

[0208] 99-102 show an exemplary artificial implant delivery device 2400 according to one embodiment. The delivery device 2400 comprises an outer shaft 2402, an annular collar or collet 2404, and an inner shaft 2406, as best shown in FIGS. 99-100. The collet 2404 may be fixedly secured or coupled to a distal end of the outer shaft 2402, and the inner shaft 2406 may extend axially through the outer shaft 2402 and the collet 2404. The inner shaft 2406 may be axially movable (i.e., distally or proximally) relative to the outer shaft 2402 and the collet 2404.

[0209] The collet 2404 of the delivery device 2400 may include a sleeve portion 2408 located at a proximal end of the collet 2404 and a number of prongs or teeth 2410 (two in the illustrated embodiment) extending axially (i.e., distally) away from a distal end of the sleeve portion 2408. Each of the teeth 2410 may include a respective radial protrusion 2412 disposed at or near a distal end of the tooth 2410 and extending radially outward from the tooth 2410. The protrusions 2412 of the teeth 2410 may be configured to couple to a proximal end of an artificial spacer device or another percutaneously delivered artificial device. For example, the artificial spacer device may have a proximally disposed annular collar (similar to the collar 112) with a number of radial openings configured to receive the protrusions 2412 of the delivery device 2400 to couple the artificial spacer to the delivery device 2400.

[0210] The collet 2404 of the delivery device 2400 may be formed from a material that allows the tines 2410 to be radially resiliently expandable and compressible. For example, the collet 2404 may be formed from stainless steel. When formed from a resiliently expandable and compressible material, the tines 2410 are capable of radially expanding from a release configuration (FIGS. 101-102) to a loaded or delivery configuration (FIGS. 99-100) and vice versa, as described further below.

[0211] Delivery device 2400 may be used to deliver a prosthetic spacer device 2414 percutaneously to a native heart valve (e.g., mitral valve) as shown in Figures 99-102. The prosthetic spacer 2414 may include an anchor 2416. Delivery device 2400 may be used as part of a delivery apparatus that includes, for example, an outer catheter (not shown but similar to outer catheter 212), an intermediate or guide catheter (not fully shown but similar to guide catheters 1300, 1400), and delivery device 2400.

[0212] The outer catheter can be used, for example, to cross the septum and open into the left atrium of the heart. An intermediate or guide catheter with an implant cover or sheath 2418 can be advanced through the outer catheter and into the mitral valve together with the delivery catheter 2400, such that the anchor 2416 is located in the left ventricle, for example, as shown in FIG. 99. The spacer 2414 can then be deployed from within the sheath 2418 by advancing the delivery catheter 2400 distally relative to the sheath 2418 or retracting the sheath proximally relative to the delivery catheter, as shown in FIG. 100. The delivery device 2400 can be used to desirably position the spacer 2414 relative to the native valve leaflets 2420. For example, the spacer 2414 can be rotated and / or axially moved by rotating and / or advancing or retracting the outer shaft 2402, respectively.

[0213] Once the spacer 2414 is desirably positioned and fixed relative to the native valve cusp, the spacer 2414 can be removed from the delivery device 2400. As shown in FIG. 101, the spacer 2414 can be removed from the delivery device 2400 by retracting the inner shaft 2406 relative to the collet 2404 and the outer shaft 2402 such that the teeth 2410 are radially compressed and the protrusion 2412 can move radially inwardly away from the spacer 2414, whereby the protrusion 2412 is disengaged from the spacer 2414. As shown in FIG. 102, with the protrusion 2412 disconnected from the spacer 2414, the spacer 2414 can be removed and the delivery device 2400 and the sheath 2418 can be retracted through the outer catheter.

[0214] However, if a physician desires to reposition the spacer 2414 after removal of the delivery device 2400, the physician can reattach the delivery device 2400 to the spacer 2414 by reversing the above-described steps for removing the spacer 2414.

[0215] FIG. 103 shows an exemplary embodiment of an annular collar or collet 2500 for a delivery catheter that is similar to the collet 2404 of the delivery device 2400. The collet 2500 can include a sleeve 2502 and a plurality of teeth 2504 (four in the illustrated embodiment) that extend axially away from the distal portion of the sleeve 2502. As shown, each tooth 2504 can include a protrusion 2506 that extends radially outwardly from the distal end of each tooth 2504. Each protrusion is configured to extend into each opening of the implant to be delivered. The collet 2500 can function and be used substantially the same as the collet 2404 of the delivery device 2400.

[0216] 104-106 show another exemplary embodiment of a prosthetic implant delivery device 2600 similar to delivery device 2400. Delivery device 2600 includes an outer shaft (not shown but similar to outer shaft 2402), an annular collar or collet 2602, and an inner shaft 2604, as best shown in FIG. 104. Collet 2602 may be fixedly secured or coupled to a distal end of the outer shaft, and inner shaft 2604 may extend coaxially through the outer shaft and collet 2602. Inner shaft 2604 may be coaxially movable (i.e., distally or proximally) relative to outer shaft 2402 and collet 2404.

[0217] The collet 2602 of the delivery device 2600 may include a sleeve portion 2606 located at a proximal end of the collet 2602 and a number of prongs or teeth 2608 (two in the illustrated embodiment) extending axially (i.e., distally) away from a distal end of the sleeve portion 2606. Each of the teeth 2608 may include a respective projection 2610 disposed at or near a distal end of the tooth 2608 and extending radially outward from the tooth 2608. The projections 2610 of the teeth 2608 may be configured to couple to a proximal end of a prosthetic implant device (e.g., a prosthetic spacer). For example, the prosthetic spacer device may have a proximally disposed annular collar 2612 with a number of radial openings 2614 configured to receive the projections 2610 of the delivery device 2600.

[0218] Similar to the delivery device 2400, the delivery device 2600 may be coupled to the collar 2612 of the artificial implant by retracting the inner shaft 2604 proximally relative to the collet 2602 and outer shaft (not shown) such that the distal end of the inner shaft 2604 is located proximally within the sleeve 2606 of the collet 2602, as shown in FIG. 105. Retracting the inner shaft 2604 allows the teeth 2608 to radially compress so that they may be inserted into the collar 2612 of the artificial implant (see FIG. 105).

[0219] 106 , the implant may be secured to the delivery device 2600 by aligning the projection 2610 of the delivery device 2600 with the opening 2614 of the implant, and advancing the inner shaft 2604 distally relative to the collet 2602 and outer shaft (not shown), such that the inner shaft 2604 extends axially through the tines 2608. By advancing the inner shaft 2604 through the tines 2608, the tines 2608 expand radially and force the projection 2610 into the opening 2612 of the implant, thus securing the implant to the delivery device 2600.

[0220] 107-110 show an exemplary artificial implant delivery device 2700 similar to delivery device 2400, according to one embodiment. The delivery device 2700 includes an outer shaft 2702, an annular collar or collet 2704, and an inner shaft 2706, as best shown in FIGS. 109-110. The collet 2704 may be fixedly secured or coupled to a distal end of the outer shaft 2702, and the inner shaft 2706 may extend coaxially through the outer shaft 2702 and the collet 2704. The inner shaft 2706 may be axially movable (i.e., distally or proximally) relative to the outer shaft 2702 and the collet 2704.

[0221] The collet 2704 of the delivery device 2700 may include a sleeve portion 2708 located at a proximal end of the collet 2704 and a number of prongs or teeth 2710 (two in the illustrated embodiment) extending axially (i.e., distally) away from a distal end of the sleeve portion 2708. Each of the teeth 2710 may include a respective projection 2712 disposed at or near a distal end of the tooth 2710 and extending radially inward from the tooth 2710. The projections 2712 of the teeth 2710 may be configured to couple to a proximal end of a prosthetic spacer device. For example, the prosthetic spacer device may have a proximally disposed annular collar (similar to the collar 112) with a number of radial openings configured to receive the projections 2712 of the delivery device 2700 to couple the prosthetic spacer to the delivery device 2700.

[0222] The collet 2704 of the delivery device 2700 may be formed from a material that allows the tines 2710 to be radially resiliently expandable and compressible. For example, the collet 2704 may be formed from stainless steel. As described further below, when formed from a resiliently expandable and compressible material, the tines 2710 are capable of radially expanding from a loaded delivery configuration (FIGS. 107-108) to a released configuration (FIGS. 101-102) and vice versa.

[0223] Delivery device 2700 may be used to deliver a prosthetic spacer device 2714 percutaneously to a native heart valve (e.g., mitral valve) as shown in Figures 107-110. Prosthetic spacer 2714 may include anchors 2716 and annular collar 2718. Delivery device 2700 may be used as part of a delivery apparatus that includes, for example, an outer catheter (not shown but similar to outer catheter 212), an intermediate or guide catheter (not fully shown but similar to guide catheters 1300, 1400), and delivery device 2700.

[0224] The outer catheter can be used, for example, to cross the septum and open into the left atrium of the heart. An intermediate or guide catheter with an implant cover or sheath 2718 can be advanced through the outer catheter and into the mitral valve together with the delivery catheter 2700 such that the anchor 2716 is located within the left ventricle, for example, as shown in FIG. 107. The spacer 2714 can then be deployed from within the sheath 2718 by advancing the delivery catheter 2700 distally relative to the sheath 2718 or retracting the sheath proximally relative to the delivery catheter, as shown in FIG. 108. The delivery device 2700 can be used to desirably position the spacer 2714 relative to the native valve leaflets 2720. For example, the spacer 2714 can be rotated and / or axially moved by rotating and / or advancing or retracting the outer shaft 2702, respectively.

[0225] Once the spacer 2714 is desirably positioned and secured relative to the native valve leaflets, the spacer 2714 may be removed from the delivery device 2700. As shown in FIG. 109, the spacer 2714 may be removed from the delivery device 2700 by distally advancing the inner shaft 2706 relative to the collet 2704 and outer shaft 2702, causing the tines 2710 to radially expand and the protrusions 2712 to move radially outward away from the spacer 2714, thereby disengaging the protrusions 2712 from the spacer 2714. As shown in FIG. 110, with the protrusions 2712 decoupled from the spacer 2714, the spacer 2714 may be removed and the delivery device 2700 and sheath 2718 may be retracted through the outer catheter.

[0226] However, if the physician wishes to reposition the spacer 2714 after removal of the delivery device 2700, the physician may reattach the delivery device 2700 to the spacer 2714 by following the steps described above for removing the spacer 2714 in reverse order.

[0227] 111 illustrates an example embodiment of an annular collar or collet 2800 that is similar to the collet 2704 of the delivery device 2700. The collet 2800 may include a sleeve 2802 and a number of tines 2804 (four in the illustrated embodiment) extending axially away from a distal portion of the sleeve 2802. As shown, each tine 2804 may include a protrusion 2806 extending radially inward from a distal end of each tine 2804. The collet 2800 may function and be used in a substantially similar manner to the collet 2704 of the delivery device 2700.

[0228] 112 shows a cross-sectional view of an exemplary non-circular shaft 2901 of a delivery device 2900 according to one embodiment. As shown, the shaft 2901 can have a non-circular cross-sectional profile in a plane perpendicular to the longitudinal axis of the shaft. For example, the shaft 2901 can have an elliptical cross-sectional profile with a major axis (represented by dashed line 2902) and a minor axis (represented by dashed line 2904). The elliptical cross-sectional shape can allow the delivery system 2900 to flex more easily about the major axis 2902 than the minor axis 2904, for example. In this manner, the delivery device 2900 can be advanced through a tortuous passageway (e.g., the vasculature) by rotating the catheter as necessary at each successive bend in the passageway so that the major axis is approximately perpendicular to the direction of the bend in the passageway.

[0229] 113 illustrates a cross-sectional view of an exemplary non-circular delivery device 3000 according to another embodiment. As shown, the delivery device 3000 can include a shaft 3002 that includes a "D" shaped cross-sectional profile.

[0230] Advantageously, the use of a non-circular delivery device (e.g., devices 2900, 3000) with a non-circular prosthetic device (a prosthetic device having a non-circular cross-sectional profile in a plane perpendicular to the longitudinal axis of the prosthetic device) may allow for more controlled deployment, e.g., with a more uniform deployment force. For example, by combining an elliptical shaped prosthesis with an elliptical shaped delivery system, the deployment force may be more uniform radially about the circumference of the prosthesis. This uniformity may allow for greater predictability and therefore control, e.g., during the deployment procedure.

[0231] It is noted that the delivery devices 2900, 3000 can comprise, for example, non-circular catheters and / or non-circular delivery sheaths, and that the delivery devices 2900, 3000 can be used, for example, with both circular and non-circular implantable prosthetic devices.

[0232] 114-127F illustrate various embodiments of implantable prosthetic devices having auxiliary anchoring members to permit engagement of the anchors of the device to the native valve leaflets.

[0233] FIG. 114 shows a prosthetic device 3100 comprising an annular body 3102 and an anchor 3104 extending from the body. A piece of friction-enhancing material 3106 may be attached on the exterior of the body 3102 at a location opposite the anchor 3104. In certain embodiments, the friction-enhancing material 3106 may comprise, for example, a plastic hook material such as Velcro®. When implanted within the native valve, the anchor 3104 may compress the native leaflets against the friction-enhancing material 3106 to enhance the anchor's retention. In the illustrated embodiment, the friction-enhancing material 3106 is shown attached directly to the frame of the body (e.g., with sutures). In certain embodiments, the body is covered with a blood-impermeable cover (e.g., fabric) and the friction-enhancing material 3106 may be attached on the exterior of the cover.

[0234] 115 shows a prosthetic device 3200 comprising an annular body 3202, a fabric covering 3204, and anchors 3206 extending from the body. Attached to each anchor 3206 may be one or more protrusions 3208 formed from suture material wrapped around the anchor, from a glue or other adhesive applied to the anchor, or from a polymeric material bead or ball molded or otherwise secured to the anchor. When implanted within the native valve, the anchors 3206 may bias the protrusions 3208 against the native valve leaflets to enhance the anchor's retention.

[0235] 116 shows a prosthetic device 3300 comprising an annular body 3302, a fabric covering 3304, and anchors 3306 extending from the body. Attached on each anchor 3306 may be one or more protrusions 3308 formed from a metal wire secured to the end of the anchor. When implanted within the native valve, the anchors 3306 may urge the protrusions 3308 against the native valve leaflets to enhance the anchor's retention.

[0236] 117 illustrates an example anchor 3400 that may be secured to the body of a prosthetic device (any of the prosthetic devices disclosed herein). The anchor 3400 may include one or more barbs or projections 3402 that may engage and optionally pierce the leaflets when implanted to enhance the anchor's retention.

[0237] 118 shows a prosthetic device 3500 comprising an annular body 3502, a fabric covering 3504, and an anchor 3506 extending from the body. The body may have one or more barbs or projections 3508 attached to a frame thereof that extend through the covering 3504. When implanted within the native valve, the anchor 3506 may compress the native leaflets against the projections 3508 (and optionally penetrate the leaflets), enhancing the anchor's retention.

[0238] 119A-119F show a prosthetic device 3600 comprising an annular body 3602, a fabric cover (not shown), and anchors 3604 extending from the body. An end of each anchor 3604 may be coupled to a respective strut of the body 3602 by a respective sleeve 3606 that may be crimped around an end portion of the anchor and the strut of the body. One or more barbs or projections 3608 may be attached to the frame of the body. The free ends of the projections 3608 in the illustrated embodiment are configured to lie generally within the body and do not necessarily extend through the fabric cover (as shown in FIG. 118). However, the protrusions 3608 can exert a retaining force on the native leaflets by the anchors 3604, which are shaped to push the native leaflets inwardly into the body in the area below the free ends of the anchors 3604 when moved from the open position (Figures 119E and 119F) to the closed position (Figures 119A-119D).

[0239] 120A-120C show a prosthetic device 3700 comprising an annular body 3702, a fabric covering (not shown), an anchor 3704 extending from the body, a sleeve 3706 coupling the anchor to the body, and a protrusion 3708 extending from the body. The device 3700 is similar to device 3600, except that the anchor 3704 comprises an intermediate portion 3710 shaped to extend inwardly into the area below the protrusion 3708 when the anchor is in the closed position as shown in the figures. In this manner, the intermediate portion 3710 helps press the native leaflets inwardly against the protrusion 3708, thereby enhancing engagement of the device within the native leaflets.

[0240] 121A-121D show a prosthetic device 3800 comprising an annular body 3802, a fabric cover (not shown), an anchor 3804 extending from the body, a sleeve 3806 coupling the anchor to the body, and a protrusion 3808 extending from the body. The anchor 3804 comprises a middle portion 3810 that presses the native leaflets inwardly against the protrusion 3808, and an outwardly extending protrusion 3812 that presses the native leaflets against the body in the area above the protrusion. Both lower legs of the anchor 3804 in the illustrated embodiment comprise coil springs 3814 that act as spring hinges that may spread the anchor away from the body, but provide a spring force that biases the anchor against the body when the opening force is removed from the anchor.

[0241] 122A-122D show a prosthetic device 3900 comprising an annular body 3902, a fabric cover (not shown), an anchor 3904 extending from the body, a sleeve 3906 coupling the anchor to the body, and a projection 3908 extending from the body. Similar to device 3800, the lower leg of the anchor 3904 may comprise a coil spring 3814 that acts as a spring hinge to open and close the anchor. Unlike the previous embodiment, the projection 3908 extends radially outward and downward toward the ventricular end of the body and is mounted on an outwardly curved strut member 3916 of the body that projects outwardly through the anchor 3908 when pivoted to a closed position.

[0242] 123A-123D show a prosthetic device 4000 comprising an annular body 4002, a fabric cover (not shown), an anchor 4004 extending from the body, a sleeve 4006 connecting the anchor to the body, and a protrusion 4008 extending from the body. The anchor 4004 comprises a middle portion 4010 that presses the native leaflets inward against the protrusion 4008, and an outwardly extending protrusion 4012 that presses the native leaflets against the body in the area above the protrusion. Both lower legs of the anchor 4004 in the illustrated embodiment comprise a coil spring 4014 that acts as a spring hinge to open and close the anchor. The device 4000 is similar to device 3800, except that each spring 4014 has end portions 4016 that extend upward from the coil portion 4018 and curve back downward where they are connected to struts of the body by one or more sleeves 4006. 124A-124F are various views of device 400 showing the anchors in a closed position (FIG. 124A), a fully open position (FIG. 124D), and various partially open positions (FIGS. 124B-124C, 124E, and 124F).

[0243] 125A-E show a prosthetic device 4100 comprising a generally spherical or bulbous body 4102, anchors 4104 coupled to the body, and protrusions 4106 extending outwardly from the body. In certain embodiments, the body 4102 and anchors 4104 may comprise braided or woven structures, such as metal braids or weaves, as described in the embodiments above. As best shown in FIG. 125E (showing the anchors in a partially deployed position), each anchor 4104 comprises a first bendable portion 4108 having one end coupled to the ventricular end of the body and a second bendable portion 4110 having one end coupled to the lower ring 4112. When the device 4100 is fully deployed, the bendable portions 4108, 4110 are bent upwardly alongside the body 4102 such that the native leaflets are captured between the body and the bendable portions 4108 with the projections 4106 engaging the native leaflets. As shown in Figures 125A-125D, the ring 4112 is moved upwardly around the lower end portions of the bendable portions 4108, 4110 to hold the device in place against the native leaflets by resisting movement of the anchors away from the closed position.

[0244] 126A-126J show a prosthetic device 4200. The device 4200 is similar to the device 4100 in that it comprises a generally spherical or bulbous body 4202 and an anchor 4204 coupled to the body. The body 4202 and anchor 4204 may comprise a braided or woven structure, such as a metal braid or woven structure, as described in the embodiments above. Each anchor 4204 may comprise a first bendable portion 4208 having one end coupled to the ventricular end of the body and a second bendable portion 4210 having one end coupled to a lower ring 4212. Unlike device 4100, projections 4206 are attached to an inner surface of second bendable portion 4210, and first bendable portion 4208 may be formed with slots or openings 4214 that allow projections 4206 to extend therethrough and engage the native valve leaflets when anchor 4204 is moved to a closed, fully deployed position. FIG. 126A shows anchor 4204 in a partially deployed state where the anchor is partially bent. FIG. 126B shows a detailed view of a portion of body 4202 as shown in FIG. 126A. FIGS. 126C-126F show the anchor in a further partially deployed state where the anchor is further bent from the position shown in FIG. 126A. 126G-126J show the anchor in a fully deployed, folded, closed state alongside the body 4202 with the projections 4206 extending through openings in the first bendable portion 4208 and engaging the native leaflets. Although not shown, the anchor can be fully expanded into a delivery configuration by moving the ring 4212 further axially away from the body 4202 relative to the partially folded state shown in FIG.

[0245] 127A-127F show a prosthetic device 4300. The device 4300 is similar to the device 4100 in that it includes a generally spherical or bulbous body 4302 and an anchor 4304 coupled to the body. The body 4302 and anchor 4304 may include a braided or woven structure, such as a metal braid or weave, as described in the embodiments above and as best shown in FIGS. 127E and 127F. The device 4300 includes a lower ring or sleeve 4312. Each anchor 4304 may include a first inwardly bendable portion 4308 coupled at one end to a lower end 4314 of the body 4302 and a second outwardly bendable portion 4310 coupled at one end to an upper end 4316 of the lower ring 4312. The first foldable portion 4308 extends upward from the lower end 4314 of the main body 4302, passes through an opening in the second foldable portion 4310, and then curves outward and downward where it is connected to the upper end of the second foldable portion 4310.

[0246] During delivery, the lower sleeve 4312 is spaced from the body (similar to FIG. 126A ) so that the lower sleeve does not overlap the anchor and the bendable portion of the anchor is bent away from the body. The device is deployed so that the native leaflets are positioned on either side of the body and the anchor is bent upward toward the body to a fully deployed position ( FIG. 127A ) where the native leaflets are engaged between the body 4302 and the first bendable portion 4308. Bending the anchor pulls the sleeve 4312 over the lower end portion of the first bendable portion 4308 to hold the anchor in the fully deployed position.

[0247] Incorporating auxiliary anchoring members as shown in Figures 114-127F allows the structural components of the prosthetic device (e.g., the metal frame of the body and / or the anchors) to be relatively thinner and / or more flexible, resulting in a device that is more easily folded for loading into a delivery sheath and more flexible to navigate small diameter bends as it is advanced toward an implantation site.

[0248] 128 illustrates an alternative embodiment of a steering control mechanism 4400 that may be incorporated into any of the delivery devices described above (e.g., delivery device 1300) to control deflection of a distal end portion of the delivery device. The control mechanism 4400, in the illustrated embodiment, comprises a proximal control knob 4402a, a distal control knob 4402b, a first shaft 4404a and a second shaft 4404b operatively coupled to the proximal control knob 4402a, respectively, and a third shaft 4404c and a fourth shaft 4404d operatively coupled to the distal control knob 4402b, respectively. A housing 4410 (illustrated as a transparent portion in FIG. 128) houses these shafts, and the control knob may be movably coupled to the housing 4410.

[0249] The first and second shafts 4404a, 4404b are coupled to the proximal control knob 4402a by respective gears 4406a mounted on the proximal ends of the shafts. The third and fourth shafts 4404c, 4404d are coupled to the distal control knob 4402b by respective gears 4406b mounted on the proximal ends of the shafts. In this manner, rotation of the proximal control knob 4402a causes corresponding rotational movement of the first and second shafts 4404a, 4404b, and rotation of the distal control knob 4402b causes corresponding rotational movement of the third and fourth shafts 4404c, 4404d.

[0250] A respective pullwire retainer 4408a, 4408b, 4408c, and 4408d is mounted on the shaft. The proximal ends of the four pullwires (not shown) are fixedly secured to the pullwire retainer. Each pullwire retainer 4408a, 4408b, 4408c, 4408d has an internal thread that engages with an external thread on the respective shaft 4404a, 4404b, 4404c, 4404d and is fixed against rotational movement such that upon rotational movement of the control knobs 4402a, 4402b, rotation of the shafts moves the pullwire retainers axially along the shafts. The first shaft 4404a and the second shaft 4404b are threaded in opposite directions, and the third shaft 4404c and the fourth shaft 4404d are threaded in opposite directions. In this manner, rotation of the proximal control knob 4402a causes the pullwire holders 4408a, 4408b to move axially in opposite directions, and rotation of the distal control knob 4402b causes the pullwire holders 4408c, 4408d to move axially in opposite directions.

[0251] For example, when the proximal control knob 4402a is rotated to move the first pullwire retainer 4408a proximally and the second pullwire retainer 4408b distally, the pullwire attached to the first pullwire retainer 4408a is pulled and the pullwire attached to the second pullwire retainer is slack, causing the delivery device to bend or bow (upward in the illustrated embodiment) under the tension of the pullwire attached to the first pullwire retainer. In contrast, rotating the proximal control knob in the opposite direction causes the delivery device to bow (downward in the illustrated embodiment) under the tension of the pullwire attached to the second pullwire retainer 4408b. Similarly, rotating the distal control knob 4402b causes the delivery device to bow sideways to the left or right under the tension of the pullwire attached to the pullwire retainer 4408c or 4408d, depending on the direction of rotation of the distal control knob. By rotating both the proximal and distal control knobs 4402a, 4402b, the delivery device is deflected under the tension of the two in the pull wires, and thus, as will be appreciated, the delivery device can be deflected upward, downward, sideways (left or right), or in any direction in between (e.g., left or right down or left or right up).

[0252] 129-130 illustrate an exemplary embodiment of an implantable prosthetic device 4500 similar to the prosthetic device 600. The prosthetic device 4500 may include a spacer body 4502, a plurality of anchors 4504 (e.g., two in the illustrated embodiment), a plurality of fixing members 4506 (e.g., two in the illustrated embodiment), and a locking element 4508. As best shown in FIG. 129 (which shows the prosthetic device 4500 in a radially compressed configuration), a proximal end portion 4510 of the anchor 4504 may be coupled to the spacer body 4502 and a distal end portion 4512 of the anchor 4504 may be coupled to the locking element 4508. A proximal end portion 4514 of the fixing member 4506 may be coupled to the proximal end portion 4510 of the anchor 4504, and the fixing member 4506 may extend distally from the proximal end portion 4514 to a free distal end portion 4516 of the fixing member 4506.

[0253] In other embodiments, the prosthetic device 4500 may include more or fewer anchors 4504 and / or fixing members 4506. For example, in some embodiments, the prosthetic device 4500 may include three anchors 4504 and three fixing members 4506. In some embodiments, the number of fixing members 4506 can be less than or greater than the number of anchors 4504.

[0254] As shown, the spacer body 4502, anchors 4504, and / or locking elements 4508 may be formed, for example, from a braided material. In such embodiments, the spacer body 4502, anchors 4504, and / or locking elements 4508 may be covered with a blood impermeable material and / or coating.

[0255] In some embodiments, two or more of the spacer body 4502, the anchors 4504, and / or the locking elements 4508 may be formed from a single unitary piece of material. In other embodiments, the spacer body 4502, the anchors 4504, and / or the locking elements 4508 may be formed from separate pieces of material that are joined together (e.g., by welding, adhesives, fasteners, etc.).

[0256] The spacer body 4502 of the prosthetic device 4500, like the spacer body 612 of the prosthetic device 600, can be configured to reduce and / or prevent regurgitation between the native heart valve leaflets (eg, the native mitral valve leaflets).

[0257] As described above, the anchors 4504 may include a proximal end portion 4510 and a distal end portion 4512. Additionally, each of the anchors 4504 of the prosthetic device 4500 may include a joint portion 4518 disposed between the respective proximal end portion 4510 and the distal end portion 4512. As such, the anchors 4504 may be configured to move from a first configuration (e.g., a rest or unwarped configuration as shown in FIG. 129 ) to a second configuration (e.g., a warped configuration as shown in FIG. 130 ) and vice versa by pivoting at the joint portion 4518 with a delivery device (not shown) (similarly to how the anchors 610 of the prosthetic device 600 may be bent at the joint 618 using a delivery device, as shown in FIGS. 27-34 ).

[0258] Also, as described above, the fixation member 4506 may include a proximal end portion 4514 and a distal end portion 4516. The fixation members 4506 may also each include a hinge portion 4520 and a plurality of protrusions 4522. The hinge portion 4520 may be disposed between the proximal end portion 4514 and the distal end portion 4516. The protrusions 4522 may be coupled to the distal end portion 4516 and extend radially from the distal end portion 4516 (i.e., radially outward as shown in FIG. 129 and radially inward as shown in FIG. 130).

[0259] The fixation member 4506 may be configured to pivot at the hinge portion 4520 such that a delivery device may be used to move the fixation member 4506 from a first configuration (e.g., a resting or unwarped configuration as shown in FIG. 129) to a second configuration (e.g., a compressed configuration as shown in FIG. 130) and vice versa, as described further below.

[0260] In a first configuration, the fixation members 4506 may be angled at the hinge portion 4520 such that the projections 4522 of the fixation members 4506 do not extend into and / or through the respective proximal end portions 4510 of the anchors 4504. In other words, the projections 4522 are disposed radially inward (i.e., as shown in FIG. 129 ) relative to the proximal end portions 4510 of the anchors 4504. This configuration may reduce and / or prevent the projections 4522 of the fixation members 4506 from engaging (e.g., catching) on ​​a delivery cylinder (not shown) of a delivery apparatus and / or the patient's natural tissue (not shown) when the prosthetic device 4500 is loaded, positioned, and / or recaptured (e.g., during an implantation procedure).

[0261] This may be accomplished, for example, by forming the fixation member 4506 from a relatively elastic material (e.g., Nitinol) and shape-setting the fixation member 4506 such that the angle between the proximal end portion 4514 and the distal end portion 4516 at the hinge portion 4520 is less than about 180 degrees. In some embodiments, this angle can be between about 135 degrees and about 175 degrees, and in certain embodiments, can be about 155 degrees.

[0262] As described above, the fixation member 4506 may be moved from a first configuration to a second configuration using a delivery device. As shown in FIG. 130, the delivery device may move the locking element 4508 and the spacer body 4502 axially toward one another such that the anchor 4504 pivots at the joint 4518 and the locking element 4508 slides over and radially overlaps the fixation member 4506 at and / or distal to the hinge portion of the fixation member 4506. As shown in FIG. 130, the locking element 4508 and the fixation member 4506 may be configured such that the locking element 4508 presses against the fixation member 4506, thus pivoting the fixation member 4506 radially inward at the hinge portion 4520 to the second configuration. The locking element 4508 may be configured to radially expand slightly as it is slid over the fixation member 4506 when moving to the second configuration.

[0263] 130, in the second configuration, the fixation member 4506 may be angled at the hinge portion 4520 such that the protrusions 4522 at the distal end portion 4516 of the fixation member 4506 extend into and through the respective distal end portions 4510 of the anchors 4504. In other words, the protrusions 4522 may extend radially inward (i.e., as shown in FIG. 130) beyond the proximal end portion 4510 of the anchors 4504. This configuration allows the protrusions 4522 to engage natural tissue to secure the prosthetic device 4500 in the implantation position. For example, the protrusions 4522 may engage and / or penetrate natural leaflets radially disposed between the spacer body 4502 and the anchors 4504 (similar to the positioning of the prosthetic device 300 shown in FIG. 17).

[0264] Once the prosthetic device 4500 is positioned as desired, the locking elements 4508 can be secured relative to the spacer body 4502, the anchors 4504, and the fixation members 4506. This secures the prosthetic device 4500 relative to the natural tissue. The prosthetic device 4500 can then be removed from the delivery apparatus by actuating the delivery apparatus.

[0265] Prior to removal of the prosthetic device 4500, the prosthetic device 4500 may be repositioned and / or retracted with the delivery apparatus by moving the locking element 4508 relative to the fixing member 4506 such that the locking element 4508 is axially away from the fixing member 4506. This allows the fixing member 4506 to disengage from the native tissue and move from the second configuration back to the first position. The prosthetic device may then be moved relative to the native tissue and / or retracted into the delivery cylinder of the delivery apparatus while reducing the likelihood that the protrusions 4522 will engage the native tissue and / or the delivery cylinder.

[0266] Artificial valve 131-133 show an exemplary embodiment of a prosthetic heart valve 4600. The prosthetic valve 4600 may include a stent or frame 4602 (FIG. 133), a leaflet assembly 4604 supported by and secured within the frame 4602, and a cover 4606 covering portions of the frame 4602. The leaflet assembly 4604 may include one or more tissue leaflets 4608 (three in the illustrated embodiment) made from a biological material (e.g., pericardial tissue such as bovine, porcine, or equine pericardial tissue) or a synthetic material (e.g., polyurethane). The leaflets 4608 are configured to allow blood to flow in one direction through the prosthetic valve 4600 and block blood flow in the reverse direction. In FIG. 131, the leaflets 4608 are shown in solid lines to show a closed position for blocking blood flow and in dashed lines to show an open position that allows blood to flow through the prosthetic valve 4600.

[0267] 133 shows a frame 4602 without the leaflet assembly 4604 or cover 4606. The frame 4602 may include an annular body 4610 (which houses the leaflet assembly 4604), one or more first anchors 4612 extending from one end of the body 4610, and one or more second anchors 4614 extending from an opposing end of the body 4610. In the illustrated example, the prosthetic valve 4600 includes a prosthetic mitral valve implantable within a native mitral valve annulus, with the first anchor 4612 including a ventricular anchor deployed behind the native mitral valve leaflets in the left ventricle and the second anchor 4614 including an atrial anchor deployed against the native mitral valve annulus in the left ventricle. The illustrated mitral valve prosthesis 4600 includes two ventricular anchors 4612 positioned diagonally on opposite sides of the outflow end of the body 4610, and twelve atrial anchors 4614. In other embodiments, the prosthetic valve 4600 may include more or fewer ventricular anchors 4612 and / or atrial anchors 4614.

[0268] The frame 4602 may include a shape memory material, such as Nitinol (nickel titanium alloy), to allow self-expansion from a radially compressed state to an expanded state. Although not shown, if constructed from a self-expanding material, the prosthetic valve 4600 may be folded into a radially compressed state using a folding device and loaded into a sheath of a delivery catheter for delivery to an implantation site. Upon release from the sheath, the prosthetic valve 4600 may self-expand into an expanded state at the implantation site (e.g., a native mitral valve). In alternative embodiments, the frame 4602 may be plastically expandable from a radially compressed state to an expanded state by an expansion device, such as an inflatable balloon (not shown). Such plastically expandable frames may include stainless steel, chrome alloys, and / or other suitable materials. If constructed from a plastically expandable material, the prosthetic valve 4600 may be folded into a radially compressed state using a folding device onto or adjacent to a balloon (or other expansion device) of a delivery catheter. Further details regarding the folding of the prosthetic heart valve 4600 and folding devices can be found, for example, in US Pat. No. 6,399,633.

[0269] The covering 4606 can comprise a blood impermeable fabric and can extend over the exterior of the body 4610, the atrial anchor 4614, and / or portions of the ventricular anchor 4612. The fabric can include a polyester material such as polyethylene terephthalate (PET). Alternatively, the covering can include a biological material such as pericardial tissue or other biological tissue. Further details of the prosthetic valve 4600, such as its structure and assembly, are disclosed in U.S. Patent Nos. 5,993,333 and 5,993,353.

[0270] In the expanded state, the ventricular anchor 4612 extends along an outer surface of the body 4610. Thus, when implanted in the native mitral valve, the native mitral valve leaflets may be captured between the body 4610 and the ventricular anchor 4612, thereby fixing the prosthetic valve 4600 in place against systolic pressures in the left ventricle. The atrial anchor 4614 extends axially and radially outward from the inflow end of the body 4610. Thus, when implanted in the native mitral valve, the atrial anchor 4614 may be disposed in the left atrium against the native mitral valve annulus, thereby fixing the prosthetic valve 4600 in place against diastolic pressures in the left ventricle.

[0271] 134-135 show a frame 4700 for a prosthetic heart valve. The frame 4700 is configured similarly to the frame 4602 of the prosthetic heart valve 4600 (e.g., for implantation into a native mitral annulus) and may be used, for example, with the leaflet assembly 4604 and cover 4606 of the prosthetic heart valve 4600. The frame 4700 may include an annular body 4702, one or more anchors 4704 (e.g., two in the illustrated embodiment (4704a, 4704b), collectively referred to herein as "first anchors 4704") extending from one end of the body 4702, and one or more second anchors 4706 (e.g., twelve in the illustrated embodiment) extending from an opposing end of the body 4702.

[0272] In some embodiments, the first anchor 4704 may be coupled to the body 4702 by a number of tabs or sleeves 4708 (e.g., two in the illustrated embodiment (4708a, 4708b), collectively referred to herein as "tabs 4708"). The tabs 4708 may be coupled to and / or extend from a first end 4710 (e.g., outflow end) of the body 4702 (e.g., on the top or junction 4716 where the two struts of the frame 4700 come together at the frame outflow) and may be positioned on diagonally opposite sides of the body 4702 relative to one another. The tabs 4708 may be configured to fixedly receive end portions of the first anchor 4704. 134, the tabs 4708a can fixedly receive the first end portions 4712a, 4712b of each first anchor 4704a, 4704b, and the tabs 4708b can fixedly receive the second end portions 4714a, 4714b of each first anchor 4704a, 4704b. The tabs 4708 can be crimped and / or welded to the end portions and tops 4716 of the first anchors 4704 to strengthen the connection between the first anchors 4704 and the body 4702 of the frame 4700.

[0273] Advantageously, by configuring the frame 4700 such that the first anchor 4704 shares tabs 4708 at the first end portion 4712 and the second end portion 4714 of the first anchor 4704, the first anchor 4704 is balanced relative to the body 4702. As such, forces exerted on the first anchor 4704 during a dynamic cardiac cycle tend to be equal and opposite to each other and therefore cancel each other out. This may reduce and / or eliminate forces transmitted from the anchor 4704 to the body 4702 and thus reduce and / or prevent the body 4702 from bowing radially inward at the first end 4710 during a dynamic cardiac cycle.

[0274] The first anchor 4704 can be configured to pivot 180 degrees relative to the main body 4702 from a functional configuration (Figs. 134 - 135) to a compression delivery configuration (not shown) and vice versa. In the delivery configuration, the first anchor 4704 can extend axially away from the second anchor 4706 rather than towards the second anchor 4706 as shown in Figs. 134 - 135. Thus, the first anchor 4704 does not increase the radial profile of the frame 4700. This is because the first anchor 4704 does not radially overlap the main body 4702. This can be achieved, for example, by forming the first anchor 4704 from a relatively flexible material such as nitinol, stainless steel, and / or chrome alloy. An artificial valve with a frame 4700 can be delivered using a delivery device such as that disclosed in Patent Document 2, which can be configured to control the pivotal movement of the first anchor 4704 between the delivery configuration and the functional configuration with the natural valve leaflet captured between the anchors of the main body.

[0275] The geometry of the first anchor 4704 can have various configurations. For example, the shape, dimensions, etc. can be set for a particular implantation location (e.g., natural mitral valve, aortic valve, pulmonary valve, and / or tricuspid valve) and / or for a desired bending profile and / or functional radial profile.

[0276] In other embodiments, the frame 4700 can include a greater or fewer number of first anchors 4704 and / or second anchors 4706. For example, the frame 4700 can be configured to include three first anchors 4704.

[0277] General Consideration Requirements For purposes of this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. On the contrary, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with each other. These methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments are not required for any one or more particular advantages to exist or problems to be solved.

[0278] Although some operations of the method of the present disclosure are described in a specific order for convenience, it should be understood that the described method encompasses reordering unless a specific order is required by a specific description. For example, operations described sequentially may be reordered or performed simultaneously in some cases. Furthermore, for simplicity, the accompanying drawings may not show various ways in which the disclosed method can be used in combination with other ways. In this specification, the terms "a" and "at least one" encompass one or more of a specific element. That is, if two specific elements are present, one of these elements is also present, and therefore there is a "a" element. The term "multiple" means two or more specific elements.

[0279] As used herein, the term "and / or" between at least two listed elements means any one or more of the listed elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."

[0280] As used herein, the term "coupled" generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled items unless specifically stated to the contrary.

[0281] In view of the many possible embodiments to which the inventive principles of this disclosure may be applied, it is to be understood that the illustrated embodiments are merely preferred examples of the invention and should not be construed as limiting the scope of the invention, which is rather defined by the appended claims, and we therefore claim as our invention anything that comes within the scope and spirit of these claims. [Explanation of symbols]

[0282] 10 Implantable artificial devices 12 Ventricular part 14 Spacer body 16 Inner shaft 18 Color 20 Ventricular anchor 22 End Cap 24 Collar or Nut 26 Outer shaft or sleeve 28 Circular metal frame 30 Blood-impermeable fibers 100 Implantable artificial devices 102 Ventricular anchor 104 Spacer body 106 Threaded Shaft 108 Proximal Nut 110 First Annular Collar 112 Second Annular Collar 114 Strut 116 Distal stopper 118 Stopping member 200 Implantable artificial devices 202 Delivery device 204 Expandable spacer body 206 Ventricular anchor 208 Shaft 210 Nut 212 External Catheter 214 Implant Catheter 216 Delivery Sheath 218 Nut support shaft 220 Torque Shaft 222 Septum 224 Left atrium 226 Guidewire 228 Valve Leaflet 300 Implantable artificial devices 302 Ventricular part 304 Spacer body 306 Shaft 308 Proximal end 310 Anchor 312 Delivery device 314 Device Catheter 316 Delivery Sheath 318 Shaft 320 Guidewire 322 Septum 324 Left atrium 326 Mitral valve leaflet 328 Left ventricle 400 Implantable artificial devices 402 Ventricular end portion 404 Spacer body 406 Shaft 408 Proximal end portion 410 Anchor 412 Wires, sutures, tethers, or strings 414 clips 416 Friction element 418 Distal end 420 Proximal end 422 Middle part 424 Arrow direction 500 Implantable artificial devices 502 Ventricular part 504 Spacer body 506 Inner Shaft 508 Distal end 510 Proximal end 512 Ventricular anchor 514 End cap, distal sleeve 516 Intermediate Sleeve 518 Proximal Sleeve or Shaft 520 Sheath 522 Aperture 600 Implantable artificial devices 602 Inner Shaft 604 End Cap 606 Braided part 608 Outer Shaft 610 Anchor part 612 Main body part 614 Lower leg 616 Upper leg 618 Joint 620 Connecting sleeve 622 Implant Catheter 624 Delivery Sheath 700 Implantable artificial devices 702 Ventricular anchor 704 Spacer body 706 Anchor operating line 708 Pull Wire 710 Color 712 Leaflet retention element 714 Braided part 716 First End 718 Natural valve cusp 800 Implantable artificial devices 802 Ventricular anchor 804 Spacer body 806 Shaft 808 First Annular Collar 810 Second Annular Collar 812 Interconnecting Strut 814 Tube 816 Pull Wire 818 Threaded Bolt 820 Washer 822 Shaft or Shim Support Sleeve 824 Nut 826 Nut Support Rail 828 External notch or groove 830 Circumferential rib 832 Non-opening or spine 834 Non-cut transition section 836 Native mitral valve leaflet 838 First Cut Section 840 Second Cut Section 842 first proximal end 844 Second Distal End 846 Arrow direction 900 Implantable artificial devices 904 End Cap 906 Braided part 910 Anchor 912 Spacer body 914 Lower leg 916 Upper leg 1000 Implantable artificial devices 1002 Ventricular anchor 1004 Spacer body 1008 First Annular Collar 1010 Second annular collar 1012 Strut 1014 Tube 1016 Rib 1018 Non-opening or spine 1020 Proximal end 1100 Implantable artificial devices 1102 Ventricular part 1104 Spacer body 1106 Inner shaft 1108 Outer shaft 1110 Outer anchor member 1112 Inner anchor member 1114 Horizontal member 1116 First pivotable joint 1118 Second pivotable joint 1120 Arrow 1122 third pivotable joint 1124 Fourth pivotable joint 1126 Connected Elements 1128 Blood-impermeable fiber 1130 Valve Leaflet 1200 Implantable artificial devices 1202 Anka 1204 Arrow 1206 Shaft 1208 Sleeve 1210 Outer member 1212 Inner member 1214 Cross member 1216 First pivotable joint 1218 Second pivotable joint 1220 Third pivotable joint 1222 Fourth pivotable joint 1224 Opening 1300 Flexible artificial implant delivery device 1302 Implant cover or sheath 1304 Flexible radially expandable basket portion 1306 Intermediate shaft 1308 Basket expansion mechanism 1310 Proximal shaft 1312 Manipulation control member 1314 Gasket expansion wire 1316 Manipulation control wire 1318 First distal end 1320 Second proximal end 1322 First distal end 1324 Second proximal end 1326 Implant lumen or working lumen 1328 Wire lumen 1330 Radially extending side opening or port 1332 First distal section 1334 Second proximal section 1338 Distal nut 1340 Proximal nut 1342 Outer nut or sleeve 1344 First female thread 1346 Second female thread 1348 Implant lumen 1350 Side opening or port 1352 Control handle 1354 Sleeve 1356 Spherical or at least partially spherical outer surface 1358 Socket 1360 Axially extending opening 1362 End Caps or Ferrules 1364 Artificial Spacer Device 1366 Mitral valve 1368 Heart 1370 External Catheter 1371 Left atrium 1372 Natural valve cusp 1374 Arrow 1376 Arrow Direction 1378 Arrow Direction 1400 Steerable artificial implant delivery device 1402 Inner shaft 1404 Intermediate shaft 1406 Outer shaft 1408 Control member 1410 Tensioner 1412 Hemostatic seal 1414 Ball 1416 Handle 1418 Ring 1420 Annular notch or groove 1422 Nut guide adapter 1424 Drive Nut 1426 Stopper washer 1428 Wire tension adjustment knob 1430 Adjustment nut washer 1432 End Cap 1436 Sliding Notch or Port 1438 Slotted Metal Tube 1440 Spine 1442 Strut 1444 Annular Collar 1446 Opening, tab 1448 Axial Section 1450 Axial Section 1452 Axial Section 1454 Axial Column 1454a Axial extending row 1454b Axial extending row 1454c Axial extending columns 1454d Axial extending row 1456 Distal end 1500 Control member 1502 Ball 1504 Socket 1504a First socket part 1504b Second socket part 1506 clips 1508 Concave part 1510 Protrusion 1512 Ball Contact Surface 1514 Groove or slot 1516 Tabs 1518 Groove 1520 Groove 1522 Internal opening or lumen 1526 Fixing mechanism 1528 Arrow direction 1600 Control member 1602 Ball 1604 Socket 1606 clips 1608 Concave part 1610 Rod or shaft 1612 Ball Contact Surface 1614 Groove or slot 1616 Tab 1618 Groove 1620 Internal opening or lumen 1700 Control parts 1702 Ball 1704 Socket part 1706 clips 1708 Pins or protrusions 1710 Concave part 1712 Guide rail 1714 Tracks or Channels 1800 Control parts 1802 Ball 1804 Socket part 1806 clips 1808 Protrusion 1810 Recess or channel 1900 Control parts 1902 Ball 1904 Socket part 1906 Rock 1908 Male thread part 1910 Flange or handle part 1912 Approximate spherical inner surface 1914 Nobu 2000 Lock Device 2002 Coupler or Sleeve 2004 Housing 2005 Distal shaft section 2006 Fastener part 2008 Lumens 2010 Male Threaded Plug 2012 Head or knob 2014 Guiding Sheath 2016 External Catheter 2100 Catheter Position Locking Device 2102 Fixed part 2104 Moving parts 2106 Aperture 2108 Axially extending sleeve 2110 Notch or groove 2112 Aperture 2114 Axial extension pin 2200 Catheter Position Locking Device 2202 Shaft part 2204 Cam part 2206 Handle part 2208 Aperture or Lumen 2210 Flange part 2212 Annular concave portion 2214 Annular notch or groove 2216 Offset Aperture 2218 Aperture 2220 Female thread part 2300 Catheter Position Locking Device 2302 Lock Sleeve 2304 Key shaft or tube 2306 Axial extension opening 2308 Tab or Pin 2310 Groove or notch 2312 Intermediate or guide catheter 2400 Artificial Implant Delivery Device 2402 Outer shaft 2404 Annular collar or collet 2406 Inner shaft 2408 Sleeve part 2410 Prongs or teeth 2412 Protrusion 2414 Artificial Spacer Device 2416 Anchor 2418 Implant cover or sheath 2420 Natural valve cusp 2500 Annular Collet or Collet 2502 Sleeve 2504 teeth 2506 Protrusion 2600 Artificial Implant Delivery Device 2602 Annular collar or collet 2604 Inner shaft 2606 Sleeve part 2608 Prongs or Teeth 2610 Protrusion 2612 Annular Collar 2614 Aperture 2700 Artificial implant delivery device 2702 Outer shaft 2704 Annular collar or collet 2706 Inner shaft 2708 Sleeve part 2710 Prongs or teeth 2712 Protrusion 2714 Artificial Spacer 2716 Anka 2718 Annular collar, implant cover or sheath 2720 ​​Natural valve cusps 2800 Annular Collet or Collet 2802 Sleeve 2804 Teeth 2806 Protrusion 2900 Delivery Device 2901 Non-circular shaft 2902 Long axis 2904 Short axis 3000 Non-Circular Delivery Devices 3002 Shaft 3100 Artificial Devices 3102 Annular body 3104 Anchor 3106 Friction reinforcement material 3200 Artificial Devices 3202 Annular body 3204 Textile cover 3206 Anchor 3208 Protrusion 3300 Artificial Devices 3302 Annular body 3304 Textile cover 3306 Anka 3308 Protrusion 3400 Anka 3402 Barbs or protrusions 3500 Artificial Devices 3502 Annular body 3504 Textile cover 3506 Anchor 3508 Barbs or protrusions 3600 Artificial Devices 3602 Annular body 3604 Anchor 3606 Sleeve 3608 Barbs or protrusions 3700 Artificial Devices 3702 Annular body 3704 Anchor 3706 Sleeve 3708 Protrusion 3710 Middle part 3800 Artificial Devices 3802 Annular body 3804 Anchor 3806 Sleeve 3808 Protrusion 3810 Middle part 3812 Outwardly extending protrusion 3814 Coil spring 3900 Artificial Devices 3902 Annular body 3904 Anchor 3906 Sleeve 3908 Protrusion 3916 Outer curved strut member 4000 artificial devices 4002 Annular body 4004 Anchor 4006 Sleeve 4008 Protrusion 4010 Middle part 4012 Outwardly extending protrusion 4014 Coil spring 4016 End section 4018 Coil part 4100 Artificial Devices 4102 Nearly spherical or bulbous body 4104 Anchor 4106 Protrusion 4108 First bendable portion 4110 Second bendable portion 4112 Lower Ring 4200 Artificial Devices 4202 Nearly spherical or bulbous body 4204 Anchor 4206 Protrusion 4208 First bendable portion 4210 Second bendable portion 4212 Lower Ring 4214 Slot or opening 4300 Artificial Devices 4302 Nearly spherical or bulbous body 4304 Anchor 4308 First inwardly bendable portion 4310 Second outwardly bendable portion 4312 Lower Ring or Sleeve 4314 Lower end 4316 Upper end 4400 Steering control mechanism 4402a Proximal Control Knob 4402b Distal Control Knob 4404a 1st shaft 4404b Second Shaft 4404c 3rd shaft 4404d 4th shaft 4406a Gears 4406b Gears 4408a Pull Wire Holder 4408b Pull Wire Holder 4408c Pull Wire Retainer 4408d Pull Wire Holder 4410 Housing 4500 Implantable artificial devices 4502 Spacer body 4504 Anchor 4506 Fixing member 4508 Locking Element 4510 Proximal end portion 4512 Distal end portion 4514 Proximal end part 4516 Free distal end portion 4518 Joint part 4520 Hinge part 4522 Protrusion 4600 Artificial heart valves 4602 Stent or frame 4604 Leaflet Assembly 4606 Cover 4608 Tissue leaflet 4610 Annular body 4612 First Anchor 4614 Second Anchor 4700 frames 4702 Annular body 4704 First Anchor 4704a Anchor 4704b Anchor 4706 Second Anchor 4708 Tab or Sleeve 4708a Tab or Sleeve 4708b Tab or Sleeve 4710 First end 4712a First end portion 4712b First end portion 4714a Second end portion 4714b Second end portion 4716 Top or junction

Claims

1. 1. An implantable prosthetic device for coupling to a native mitral valve leaflet, comprising: a spacer body made from braided self-expanding metallic yarn, the spacer body configured to be disposed between the leaflets of a native mitral valve of the heart and to divide an opening between the ventricle and the atrium into two openings, the spacer body having a proximal end and a distal end; at least one anchor portion coupled to the distal end of the spacer body, the at least one anchor portion positioned against a ventricular surface of a corresponding one of the native mitral valve leaflets; a shaft extending within the spacer body, the shaft coupled to the at least one anchor portion, the shaft movable relative to the spacer body to open and close the at least one anchor portion; An implantable prosthetic device comprising:

2. 10. The implantable prosthetic device of claim 1, wherein each of the at least one anchor portion includes an upper leg attached to the distal end of the spacer body and a lower leg connected to the upper leg by a joint.

3. 3. The implantable prosthetic device of claim 1 or 2, wherein the spacer body and the at least one anchor portion are made from a single piece of braided self-expanding metallic thread.

4. The implantable prosthetic device of claim 1 or 2, wherein the spacer body is covered with a blood impermeable material.

5. The implantable prosthetic device of claim 1 or 2, wherein the distal end of the spacer body is tapered.

6. 3. The implantable prosthetic device of claim 1 or 2, wherein the spacer body is configured such that axial compression of the ends of the spacer body causes the spacer body to shorten axially and the spacer body to expand radially.

7. An implantable prosthetic device according to any one of claims 1 to 6; a delivery device having at least a portion of the shaft; An assembly comprising:

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