Highly flexible implant catheter with low compressibility

Abstract

An implant catheter is provided having a highly flexible section, the highly flexible section including a liner disposed adjacent to a catheter coil. Some implementations of the implant catheter include a section in which some of the inner layers of the catheter are omitted. Some other implementations include a coil formed from a wire having a self-aligning cross section.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Application No. 63 / 003,125, filed March 31, 2020, and U.S. Provisional Application No. 63 / 027,266, filed May 19, 2020, both of which are incorporated herein by reference in their entireties. [Background technology]

[0002]

[0003] Natural heart valves (i.e., aortic, pulmonary, tricuspid, and mitral valves) play a critical role in ensuring proper forward flow of blood supply through the cardiovascular system. These heart valves can be damaged and therefore less effective due to, for example, congenital malformations, inflammatory processes, infectious conditions, disease, etc. Such valve damage can lead to serious cardiovascular risks and death. Damaged valves can be surgically repaired or replaced in open heart surgery. However, open heart surgery is highly invasive and can result in complications. Transvascular techniques can be used to introduce and implant prosthetic devices in a manner that is significantly less invasive than open heart surgery. As an example, a transvascular technique that can be used to access the natural mitral and aortic valves is the transseptal technique. The transseptal technique involves advancing a catheter into the right atrium (e.g., the catheter is inserted into the right femoral vein, advanced up the inferior vena cava, and into the right atrium). The septum is then punctured, and the catheter is threaded into the left atrium. To implant a prosthetic device within the tricuspid valve, a similar transvascular technique can be used that begins similarly to the transseptal technique but stops just short of puncturing the septum and instead directs the delivery catheter toward the tricuspid valve in the right atrium.

[0003] A healthy heart has a generally conical shape that tapers toward the inferior apex. The heart has four chambers: 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 natural mitral valve in the human heart connects the left atrium to the right ventricle. The mitral valve has a very different anatomical form from other natural heart valves. The mitral valve comprises an annulus, a circular portion of natural valve tissue surrounding the mitral orifice, and a pair of cusps, or leaflets, extending downward from the annulus into the left ventricle. The mitral annulus may form a "D" shape, an oval, or another cross-sectional shape that is not a perfect circle with long and short axes. The anterior leaflet is larger than the posterior leaflet, and when they close together, they may form a generally "C"-shaped boundary between the abutting sides of each leaflet.

[0004] When functioning properly, the anterior and posterior leaflets function together as a one-way valve, allowing blood to flow only from the left atrium to the left ventricle. The left atrium receives oxygenated blood from the pulmonary veins. When the left atrial muscle contracts and the left ventricle expands (also called "ventricular diastole" or "diastole"), the oxygenated blood collected in the left atrium flows into the left ventricle. When the left atrial muscle relaxes and the left ventricular muscle contracts (also called "ventricular systole" or "systole"), increased blood pressure in the left ventricle forces the sides of the two leaflets together, thereby closing the one-way mitral valve. As a result, blood cannot flow back into the left atrium and instead exits the left ventricle through the aortic valve. To prevent the leaflets from prolapsing under pressure and folding back from the mitral annulus toward the left atrium, multiple fibrous cords called chordae tendineae tether the leaflets to the papillary muscles of the left ventricle.

[0005] Valve regurgitation involves a valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the native mitral valve fails to close properly, allowing blood to flow from the left ventricle into the left atrium during the systolic phase of cardiac contraction. Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, including leaflet prolapse, papillary muscle insufficiency, or mitral annular elongation resulting from left ventricular dilation, or a combination of these. Mitral regurgitation in the center of the valve leaflets can be referred to as central jet mitral regurgitation, while mitral regurgitation closer to the commissure of one of the leaflets (i.e., where the leaflets meet) can be referred to as eccentric jet mitral regurgitation. Central jet mitral regurgitation occurs when the edges of the leaflets do not meet midway, thus preventing valve closure and resulting in regurgitation. Tricuspid regurgitation is similar but can occur on the right side of the heart. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent 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. 2016 / 0331523 [Patent Document 5] International Publication No. 2020 / 076898 [Patent Document 6] International Publication No. 2018 / 195215 [Patent Document 7] International Publication No. 2019 / 139904 Summary of the Invention [Means for solving the problem]

[0007] This Summary of the Invention is intended to present several examples and is not intended to limit the scope of the invention in any way. For example, none of the features included in the examples of this Summary of the Invention are required in the claims unless they are explicitly characterized in the claims. Also, features, components, steps, concepts, etc. described in the examples in this Summary of the Invention and elsewhere in this disclosure may be combined in various ways. Various features and steps described elsewhere in this disclosure may be included in the examples summarized here.

[0008] In some implementations, an implant catheter includes an outer jacket, one or more layers positioned inside the outer jacket, and a reinforcing layer positioned inside the outer jacket. At least one of the outer jacket and one or more layers is reflowed to bond the jacket, the reinforcing layer, and the one or more layers together. Some of the reinforcing layer does not contain all of the material of the outer jacket and one or more layers that are reflowed. The reinforcing layer can be a coil, a coil layer, a spring, a spring layer, a braid, a braid layer, a plurality of these, a combination of one or more of these, etc.

[0009] In some implementations, the implant catheter includes an outer jacket and one or more layers positioned inside the outer jacket. The implant catheter can also include a reinforcing layer positioned inside the outer jacket. The reinforcing layer can be a coil, a coil layer, a spring, a spring layer, a braid, a braid layer, a plurality thereof, a combination of one or more thereof, etc.

[0010] In some implementations, at least one of the outer jacket and one or more layers is reflowed to bond the jacket, the reinforcing layer (e.g., a coil, a coil layer, etc.), and the one or more layers together.

[0011] In some implementations, some of the reinforcement layers (eg, coil layers, etc.) do not use all of the material of the outer jacket and one or more layers.

[0012] In some implementations, the implant catheter further comprises a plurality of sublumens.

[0013] In some implementations, the leakage shield prevents the reflowed outer jacket and one or more layer materials from contacting a portion of the stiffener layer or coil layer, hi some implementations, the stiffener layer or coil layer is disposed inside the leakage shield.

[0014] In some implementations, a first portion of the outer jacket is formed from a material that has an enhanced level of flexibility relative to the remainder of the outer jacket.

[0015] In some implementations, the stiffening layer (eg, coil layer, etc.) is formed from self-aligning wire.

[0016] In some implementations, the implant catheter includes an outer jacket, a main lumen, and multiple layers positioned between the outer jacket and the main lumen. The implant catheter can include a reinforcing layer. The reinforcing layer can be a coil, a coil layer, a spring, a spring layer, a braid, a braid layer, multiples thereof, one or more combinations thereof, etc.

[0017] In some implementations, a portion of at least one of the multiple layers is omitted along a section of the implant catheter.

[0018] In some implementations, the leakage shield is disposed adjacent to the reinforcement layer or the coil layer in the region of the omitted layer portion, hi some implementations, the leakage shield is formed from polytetrafluoroethylene.

[0019] In some implementations, the implant catheter comprises multiple sublumens.

[0020] In some implementations, the reinforcement layer (eg, coil layer, etc.) comprises and / or is formed from self-aligning wire.

[0021] In some implementations, the implant catheter includes an outer jacket, a main lumen, multiple layers positioned between the outer jacket and the main lumen, and a reinforcing layer, which can be a coil, a coil layer, a spring, a spring layer, a braid, a braid layer, multiples thereof, one or more combinations thereof, etc.

[0022] In some implementations, the first leakage shield is positioned adjacent to the stiffening layer (eg, the coil layer) and disposed between the stiffening layer and the outer jacket.

[0023] In some implementations, the second leak shield is positioned adjacent to the reinforcement layer and disposed between the reinforcement layer and the outer main lumen. In some implementations, the first and second leak shields are formed from polytetrafluoroethylene.

[0024] In some implementations, the implant catheter comprises multiple sublumens.

[0025] In some implementations, a first portion of the outer jacket is formed from a material that has an enhanced level of flexibility relative to the remainder of the outer jacket.

[0026] In some implementations, the stiffening layer is a coil layer formed from self-aligning wire.

[0027] In some implementations, a method of manufacturing an implant catheter includes obtaining and / or providing an outer jacket and one or more additional layers. The method includes positioning the one or more additional layers inside the outer jacket. The method also includes positioning a reinforcing layer inside the outer jacket. The reinforcing layer can be a coil, a coil layer, a spring, a spring layer, a braid, a braid layer, a plurality thereof, one or more combinations thereof, etc.

[0028] In some implementations, the method includes reflowing at least one of the outer jacket and the one or more layers to bond the jacket, the reinforcing layer (e.g., a coil, a coil layer, etc.), and the one or more layers together.

[0029] In some implementations, a portion of the reinforcement layer does not use all of the material of the outer jacket and one or more layers, hi some implementations, the reinforcement layer is a coil layer, and the coil layer does not use all of the material of the outer jacket and one or more layers.

[0030] In some implementations, the method includes forming one or more sublumens within the implant catheter, which may involve positioning wires and / or mandrels in a desired arrangement relative to the sublumen prior to reflow and / or removing the wires and / or mandrels after reflow.

[0031] In some implementations, the method includes using a leakage shield to prevent material of the outer jacket and one or more layers from contacting the stiffening layer during reflow. In some implementations, the method includes positioning a stiffening layer (e.g., a coil layer, etc.) inside the leakage shield.

[0032] In some implementations, obtaining includes obtaining an outer jacket, wherein a first portion of the outer jacket is formed from a material having an enhanced level of flexibility relative to a remainder of the outer jacket.

[0033] In some implementations, the reinforcement layer (eg, coil layer, etc.) comprises and / or is formed from self-aligning wire.

[0034] In some implementations, a method of manufacturing an implant catheter includes obtaining and / or providing an outer jacket and a plurality of layers. The method includes positioning the outer jacket and the plurality of layers such that the outer jacket is radially outward of the plurality of layers and a main lumen is formed radially inward of the outer jacket and the plurality of layers. The method also includes positioning a reinforcing layer inside the outer jacket and / or inside one or more of the plurality of layers. The reinforcing layer can be a coil, a coil layer, a spring, a spring layer, a braid, a braid layer, a plurality of these, a combination of one or more of these, etc.

[0035] In some implementations, a portion of at least one of the plurality of layers is omitted along a section of the implant catheter. In some implementations, the method includes disposing a leak shield adjacent to the reinforcement layer or the coil layer in the area of ​​the omitted layer portion. In some implementations, the leak shield is formed from polytetrafluoroethylene.

[0036] In some implementations, the method includes reflowing the outer jacket and at least one of the plurality of layers to bond the jacket, the reinforcing layer (e.g., a coil, a coil layer, etc.), and the plurality of layers together.

[0037] In some implementations, the method includes forming one or more sublumens within the implant catheter, which may involve positioning wires and / or mandrels in a desired arrangement relative to the sublumen prior to reflow and / or removing the wires and / or mandrels after reflow.

[0038] In some implementations, the reinforcement layer (eg, coil layer, etc.) comprises and / or is formed from self-aligning wire.

[0039] In some implementations, a method of manufacturing an implant catheter includes obtaining, positioning, and / or arranging an outer jacket, a plurality of layers, and a reinforcing layer relative to one another such that the plurality of layers and the reinforcing layer are radially inward of the outer jacket. A main lumen can be formed radially inward of all of the outer jacket, the plurality of layers, and the reinforcing layer. The reinforcing layer can be a coil, a coil layer, a spring, a spring layer, a braid, a braid layer, a plurality thereof, a combination of one or more thereof, etc.

[0040] In some implementations, the method includes arranging and / or positioning the first leakage shield adjacent to a reinforcement layer (e.g., a coil layer) and between the reinforcement layer and the outer jacket.

[0041] In some implementations, the method includes configuring and / or positioning a second leak shield adjacent to and radially inward of the reinforcement layer and / or disposed between the reinforcement layer and the main lumen. In some implementations, the first and second leak shields are formed from polytetrafluoroethylene.

[0042] In some implementations, the method includes reflowing the outer jacket and at least one of the plurality of layers to bond the jacket, the reinforcing layer (e.g., a coil, a coil layer, etc.), and the plurality of layers together.

[0043] In some implementations, the method includes forming one or more sublumens within the implant catheter, which may involve positioning wires and / or mandrels in a desired arrangement relative to the sublumen prior to reflow and / or removing the wires and / or mandrels after reflow.

[0044] In some implementations, a first portion of the outer jacket is formed from a material that has an enhanced level of flexibility relative to the remainder of the outer jacket.

[0045] In some implementations, the stiffening layer is a coil layer formed from self-aligning wire.

[0046] A further understanding of the nature and advantages of the present invention will become apparent from the following description and claims, particularly when considered in conjunction with the accompanying drawings, in which like parts are marked with like reference numerals.

[0047] To further clarify various aspects of the implementation of the present invention, a more specific description of some examples and implementations will be provided with reference to various aspects of the accompanying drawings. It should be understood that these drawings illustrate only exemplary implementations of the present disclosure and therefore should not be considered to limit the scope of the present disclosure. Furthermore, while the figures may be drawn to scale in some examples, they are not drawn to scale in all examples. Examples and features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0048] [Figure 1]FIG. 1 is a cutaway view of a human heart in diastole. [Figure 2] FIG. 1 is a cutaway view of a human heart during systole. [Figure 3] FIG. 1 is a cutaway view of a human heart during systole showing mitral valve regurgitation. [Figure 4] FIG. 4 is a cutaway view of FIG. 3 annotated to show the natural shape of the mitral valve leaflets during systole. [Figure 5] FIG. 1 illustrates a healthy mitral valve with the leaflets closed, viewed from the atrial side of the mitral valve. [Figure 6] FIG. 1 shows a dysfunctional mitral valve with visible gaps between the leaflets as viewed from the atrial side of the mitral valve. [Figure 7] FIG. 1 is a diagram of the tricuspid valve as seen from the atrial side of the tricuspid valve. [Figure 8] 1A-1C show examples of implantable devices or implants at different stages of deployment. [Figure 9] 1A-1C show examples of implantable devices or implants at different stages of deployment. [Figure 10] 1A-1C show examples of implantable devices or implants at different stages of deployment. [Figure 11] 1A-1C show examples of implantable devices or implants at different stages of deployment. [Figure 12] 1A-1C show examples of implantable devices or implants at different stages of deployment. [Figure 13] 1A-1C show examples of implantable devices or implants at different stages of deployment. [Figure 14] 1A-1C show examples of implantable devices or implants at different stages of deployment. [Figure 15] FIG. 15 shows an example of an implantable device or implant similar to the devices shown in FIGS. 8-14, but with independently controllable paddles. [Figure 16] FIG. 15 illustrates the exemplary implantable device or implant of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 17] FIG. 15 illustrates the exemplary implantable device or implant of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 18] FIG. 15 illustrates the exemplary implantable device or implant of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 19] FIG. 15 illustrates the exemplary implantable device or implant of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 20] FIG. 15 illustrates the exemplary implantable device or implant of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 21] FIG. 15 illustrates the exemplary implantable device or implant of FIGS. 8-14 being delivered and implanted into a native valve. [Figure 22] FIG. 1 is a perspective view of an exemplary implantable device or implant in a closed state. [Figure 23] FIG. 23 is a front view of the implantable device or implant of FIG. 22. [Figure 24] FIG. 23 is a side view of the implantable device or implant of FIG. 22. [Figure 25] FIG. 23 is a front view of the implantable device or implant of FIG. 22 with a cover covering the paddles and coaptation forming elements or spacers. [Figure 26] FIG. 23 is a top perspective view of the implantable device or implant of FIG. 22 in an open position. [Figure 27] FIG. 23 is a bottom perspective view of the implantable device or implant of FIG. 22 in an open position. [Figure 28] FIG. 1 illustrates a fastener for use in an implantable device or implant. [Figure 29] FIG. 10 illustrates a portion of native valve tissue captured by a fastener. [Figure 30] FIG. 1B is a side view of an exemplary implantable device or implant in a partially opened state with the fasteners in a closed position. [Figure 31]FIG. 1B is a side view of an exemplary implantable device or implant in a partially opened state with the fasteners in an open position. [Figure 32] FIG. 1 is a side view of an exemplary implantable device or implant in a semi-open position with the clasp in a closed position. [Figure 33] FIG. 1 is a side view of an exemplary implantable device or implant in a semi-open position with the fasteners in an open position. [Figure 34] FIG. 1 is a side view of an exemplary implantable device or implant in a three-quarters open position with the clasp in a closed position. [Figure 35] FIG. 1 is a side view of an exemplary implantable device or implant in a three-quarters open position with the fasteners in an open position. [Figure 36] 1A-1C are side views of an exemplary implantable device with the clasp in a closed, fully open, or fully prolapsed position. [Figure 37] FIG. 1B is a side view of an exemplary implantable device in a fully open or fully ejected position with the catch in the open position. [Figure 38] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 39] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 40] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 41] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 42] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 43]39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 44] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 45] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 46] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 47] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 48] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 49] 39 shows the exemplary implantable device or implant of FIGS. 30-38, including a cover, delivered and implanted within a native valve. [Figure 50] 1A-1C are schematic diagrams illustrating the passage of natural valve leaflets along each side of a coaptation element or spacer of an exemplary valve repair device or implant. [Figure 51] 1 is a schematic top view illustrating the passage of the natural valve leaflets around the coaptation elements or spacers of an exemplary valve repair device or implant. [Figure 52] FIG. 1 shows a coaptation element or spacer of the native valve gap as viewed from the atrial side of the native valve. [Figure 53] FIG. 1 shows a valve repair device or implant attached to the native valve leaflets by coaptation elements or spacers in the natural valve gap, as viewed from the ventricular side of the native valve. [Figure 54]FIG. 1 is a perspective view of a valve repair device or implant attached to the native valve leaflets, showing the natural valve gap coaptation element or spacer from the ventricular side of the native valve. [Figure 55] FIG. 1 is a perspective view of an exemplary implantable device or implant in a closed state. [Figure 56] FIG. 1 is a perspective view of an exemplary fastener of an exemplary implantable device or implant in a closed position. [Figure 57] FIG. 1 is a cross-sectional view of an implant catheter. [Figure 58] FIG. 1 is a cross-sectional view of an implant catheter with multiple sublumens. [Figure 59] FIG. 1 is a perspective view of an implant catheter with a sublumen. [Figure 60] 1 is a cross-sectional view of an exemplary implant catheter. [Figure 61A] 1 is a cross-sectional view of an exemplary implant catheter. [Figure 61B] 1 is a cross-sectional view of an exemplary implant catheter. [Figure 62A] 1 is a cross-sectional view of an exemplary coil for use in an implant catheter. [Figure 62B] 1 is a cross-sectional view of an exemplary coil for use in an implant catheter. [Figure 63A] 1 is a cross-sectional view of an exemplary coil for use in an implant catheter, the coil wire having a rectangular cross-section. [Figure 63B] 1 is a cross-sectional view of an exemplary coil for use in an implant catheter, the coil wire having a rectangular cross-section. [Figure 64A] 1 is a cross-sectional view of an exemplary coil for use in an implant catheter, the coil wire having a rectangular cross-section. [Figure 64B] 1 is a cross-sectional view of an exemplary coil for use in an implant catheter, the coil wire having a rectangular cross-section. [Figure 65A]1 is a cross-sectional view of an exemplary flexible self-aligning coil. [Figure 65B] 1 is a cross-sectional view of an exemplary flexible self-aligning coil. DETAILED DESCRIPTION OF THE INVENTION

[0049] In the following description, reference is made to the accompanying drawings that illustrate exemplary implementations of the present disclosure. Other implementations that differ in structure and operation do not depart from the scope of the present disclosure.

[0050] Exemplary implementations of the present disclosure are directed to systems, devices, methods, etc. for repairing defective heart valves. For example, various implementations of implantable devices, valve repair apparatuses, implants, and sactuaystem (including systems for their delivery) are disclosed herein, and any combination of these options may be made unless specifically excluded. In other words, individual components of the disclosed devices and systems may be combined unless they are mutually exclusive or physically impossible. Furthermore, the techniques and methods herein may be performed in live animals or in simulated experiments, such as cadavers, cadaver hearts, simulated experimental devices (e.g., simulated body parts, hearts, tissues, etc.).

[0051] As used herein, when one or more components are described as being coupled, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct, such as between the components, or indirect, such as through the use of one or more intermediate components. Also, as used herein, references to a "member," "component," or "portion" are not limited to a single structural member, component, or element, but can include assemblies of components, members, or elements. Further, as used herein, the terms "substantially" and "about" are defined as at least near (and including) a given value or state (preferably within 10% of, more preferably within 1%, and most preferably within 0.1%).

[0052] Figures 1 and 2 show cutaway views of a human heart H during diastole and systole, respectively. The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA by the tricuspid valve TV and mitral valve MV, i.e., atrioventricular valves, respectively. In addition, the aortic valve AV separates the left ventricle LV from the ascending aorta AA, and the pulmonary valve PV separates the right ventricle from the pulmonary artery. Each of these valves has flexible leaflets (e.g., leaflets 20 and 22 shown in Figures 3-6 and leaflets 30, 32, and 34 shown in Figure 7) that extend inward across their respective openings and meet, or "coapt," in the flow stream to form a one-way fluid-blocking surface. The native valve repair system of the present application is often described and / or illustrated with respect to the mitral valve MV. Accordingly, the anatomy of the left atrium LA and left ventricle LV will be described in great detail. However, the devices described herein can also be used to repair other native valves, for example, the devices can be used to repair the tricuspid valve TV, the aortic valve AV, and the pulmonary valve PV.

[0053] The left atrium LA receives oxygenated blood from the lungs. During diastole (diastolic phase) as seen in FIG. 1 , blood previously collected in the left atrium LA (during systole) passes through the mitral valve MV and enters the left ventricle LV as the left ventricle LV expands. During systole (systolic phase) as seen in FIG. 2 , the left ventricle LV contracts, forcing blood through the aortic valve AV and the ascending aorta into the body. During systole, the leaflets of the mitral valve MV close to prevent blood from flowing back from the left ventricle LV into the left atrium LA, and blood is collected from the pulmonary veins into the left atrium. In some implementations, the device described herein is used to restore the function of a defective mitral valve MV. That is, the device is configured to help close the leaflets of the mitral valve to prevent blood from flowing back from the left ventricle LV into the left atrium LA. Although many of the devices described in this application are designed to easily grasp and secure the native valve leaflets around a coaptation element or spacer that advantageously acts as a filler for the regurgitant opening to prevent or inhibit reflow or regurgitation during systole, this is not required.

[0054] Referring now to Figures 1-7, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24, a fibrous ring of tissue of variable density surrounding the leaflets 20, 22. Referring to Figures 3 and 4, the mitral valve MV is anchored to the wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are cord-like tendons that connect the papillary muscles PM (i.e., the muscles at the base of the chordae tendineae CT and within the wall of the left ventricle LV) to the leaflets 20, 22 of the mitral valve MV. The papillary muscles PM limit the movement of the leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from retracting. The mitral valve MV opens and closes in response to pressure changes within the left atrium LA and left ventricle LV. The papillary muscles PM do not open or close the mitral valve MV. Rather, the papillary muscles PM support or anchor the valve leaflets 20, 22 against the high pressures required to circulate blood throughout the body. Together, the papillary muscles PM and chordae tendineae CT are known as the subvalvular apparatus and function to prevent prolapse of the mitral valve MV into the left atrium LA when the mitral valve is closed. As can be seen from the left ventricular outflow tract (LVOT) diagram shown in Figure 3, the anatomy of the valve leaflets 20, 22 is such that the medial sides of the leaflets coapt at their free ends and the leaflets 20, 22 begin to retract or splay apart from each other. The leaflets 20, 22 splay toward the atrium until each leaflet meets the mitral annulus.

[0055] Various disease processes can impair the proper function of one or more of the heart's natural valves. These disease processes include degenerative processes (e.g., Barlow's disease, fibroelastic deficiency, etc.), inflammatory processes (e.g., rheumatic heart disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle (LV) or right ventricle (RV) from a previous heart attack (i.e., myocardial infarction following coronary artery disease) or other heart diseases (e.g., cardiomyopathies, etc.) can deform the geometry of the native valve, causing it to malfunction. However, many patients who undergo valve surgery, such as mitral valve (MV) surgery, suffer from degenerative diseases that cause malfunction of the leaflets (e.g., leaflets 20, 22) of the native valve (e.g., mitral valve (MV)), resulting in prolapse and regurgitation.

[0056] In general, natural valves can malfunction in different ways, including (1) valve stenosis and (2) valve regurgitation. Valve stenosis occurs when a natural valve does not open completely, thereby causing impaired blood flow. Typically, valve stenosis results from the accumulation of calcified material on the valve leaflets, which thickens the leaflets and impairs their ability to fully open to allow forward blood flow. Valve regurgitation occurs when the valve leaflets do not close completely, thereby allowing blood to leak back into the anterior chamber (e.g., blood leaking from the left ventricle into the left atrium).

[0057] There are three major mechanisms by which native valves become regurgitant, or incompetent, including Carpentier's Type I, Type II, and Type III insufficiency. Carpentier's Type I insufficiency involves dilation of the valve annulus, where normally functioning valve leaflets deviate from one another and fail to form a tight seal (i.e., the leaflets do not coapt properly). Type I insufficiency includes perforation of the valve leaflets, as occurs in endocarditis. Carpentier's Type II insufficiency involves prolapse of one or more leaflets of the native valve above the coaptation plane. Carpentier's Type III insufficiency involves restriction of the movement of one or more leaflets of the native valve, such that the leaflets are abnormally confined below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease (Ma) or ventricular dilation (IIIb).

[0058] Referring to FIG. 5, when a healthy mitral valve MV is closed, the anterior leaflet 20 and the posterior leaflet 22 coapt, preventing blood from leaking from the left ventricle LV into the left atrium LA. Referring to FIGS. 3 and 6, mitral regurgitation MR occurs when the anterior leaflet 20 and / or the posterior leaflet 22 of the mitral valve MV displace into the left atrium LA during systole, causing the edges of the leaflets 20, 22 to not contact each other. This impaired coaptation creates a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, as illustrated by the mitral regurgitation MR flow path shown in FIG. 3, which allows blood to flow backward from the left ventricle LV into the left atrium LA during systole. Referring to FIG. 6, the gap 26 may have a width W of between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some circumstances, the gap 26 may have a width W greater than 15 mm. As previously discussed, there are a variety of different ways that a valve leaflet (e.g., the leaflets 20, 22 of the mitral valve MV) may malfunction, which may result in valvular regurgitation.

[0059] In any of the above situations, a valve repair device or implant is desired that can engage the anterior and posterior leaflets 20 and 22 to close the gap 26 and prevent backflow of blood through the mitral valve MV. As can be seen in FIG. 4 , an abstract representation of an implantable device, valve repair device, or implant 10 is shown implanted between the valve leaflets 20, 22 to prevent backflow during systole (compare FIG. 3 with FIG. 4 ). In some implementations, the coaptation elements (e.g., spacers, coaptation elements, gap fillers, etc.) of device 10 have a generally tapered or triangular shape, which naturally matches the geometry of the native valve and its propensity for expanding leaflets (toward the annulus). In this application, the terms spacer, coaptation element, coaptation element, and gap filler are used interchangeably to refer to elements that fill a portion of the space between the native leaflets and / or that are configured to engage or “coapt” the native leaflets (e.g., so that the native leaflets coapt against the coaptation elements, coaptation elements, spacers, etc. instead of only against each other).

[0060] While stenosis or regurgitation can affect any valve, stenosis is primarily found to affect the aortic valve (AV) or pulmonary valve (PV), while regurgitation is primarily found to affect the mitral valve (MV) or tricuspid valve (TV). Both valvular stenosis and regurgitation increase the workload of the heart (H) and, if left untreated, can lead to very serious conditions, including endocarditis, congestive heart failure, permanent heart damage, cardiac arrest, and ultimately death. The left side of the heart (i.e., the left atrium (LA), left ventricle (LV), mitral valve (MV), and aortic valve (AV)) is primarily responsible for circulating blood throughout the body. Therefore, because the left side of the heart experiences significantly higher pressures, insufficiency of the mitral valve (MV) or aortic valve (AV) is particularly problematic and often life-threatening.

[0061] Malfunctioning native heart valves can be repaired or replaced. Repair typically involves preserving and correcting a patient's native valve. Replacement typically involves replacing a patient's native valve with a biological or mechanical substitute. The aortic valve (AV) and pulmonary valve (PV) are typically more prone to stenosis. Because stenotic damage to the valve leaflets is irreversible, treatment for a stenotic aortic or pulmonary valve can involve removing the valve and replacing it with a surgically implanted heart valve or replacing the valve with a transcatheter heart valve. The mitral valve (MV) and tricuspid valve (TV) are more prone to deformation of the leaflets and / or surrounding tissue, which, as described above, can prevent the mitral valve (MV) or tricuspid valve (TV) from closing properly and allow blood to regurgitate, or backflow, from the ventricle to the atrium (e.g., a deformed mitral valve (MV) can allow regurgitation, or backflow, from the left ventricle (LV) to the left atrium (LA), as shown in Figure 3). Regurgitation, or backflow, of blood from the ventricle to the atrium can lead to valvular insufficiency. Deformities in the structure or shape of the mitral valve MV or tricuspid valve TV are often repairable. Additionally, regurgitation can occur due to dysfunctional chordae tendineae CT (e.g., the chordae tendineae CT can stretch or tear), causing the anterior and posterior leaflets 20 and 22 to backtrack, allowing blood to flow back into the left atrium LA. These problems caused by dysfunctional chordae tendineae CT can be corrected by repairing the chordae tendineae CT or mitral valve MV structures (e.g., by fixating the leaflets 20, 22 in the affected portion of the mitral valve).

[0062] The devices and procedures disclosed herein often refer to repairing the structure of the mitral valve. However, it should be understood that the devices and concepts presented herein can be used to repair any native valve, as well as any component of a native valve. Such devices can be used between the leaflets 20, 22 of the mitral valve MV to prevent or block the backflow of blood from the left ventricle to the left atrium. With respect to the tricuspid valve TV (FIG. 7), any of the devices and concepts described herein can be used between any two of the anterior leaflet 30, septal leaflet 32, and posterior leaflet 34 to prevent or block the backflow of blood from the right ventricle to the right atrium. In addition, any of the devices and concepts presented herein can be used on all three leaflets 30, 32, and 34 together to prevent or block the backflow of blood from the right ventricle to the right atrium. That is, the valve repair device or implant presented herein can be centered between the three leaflets 30, 32, and 34.

[0063] An exemplary implantable device (e.g., an implantable prosthetic device, etc.) or implant can optionally have a coaptation element (e.g., a spacer, coaptation element, gap filler, etc.) and at least one anchor (e.g., one, two, three, or more). In some implementations, the implantable device or implant can have any combination or subcombination of the features disclosed herein without a coaptation element. When included, the coaptation element (e.g., a coaptation element, a spacer, etc.) is configured to be positioned within the native heart valve orifice to fill the space between the leaflets and help form a more effective seal, thereby reducing or preventing the aforementioned backflow. The coaptation element can have a structure that is blood-impermeable (or resists blood flow therethrough) that allows the native valve leaflets to close around the coaptation element during ventricular contraction, preventing blood from flowing back into the left or right atrium, respectively. The device or implant can be configured to seal two or three native valve leaflets. That is, the device can be used with native mitral (bicuspid) and tricuspid valves. The coaptation element is sometimes referred to herein as a spacer because it can fill the space between improperly functioning native valve leaflets (e.g., mitral valve leaflets 20, 22 or tricuspid valve leaflets 30, 32, 34) without completely closing.

[0064] The optional coaptation elements (e.g., spacers, coaptation elements, etc.) can have a variety of shapes. In some implementations, the coaptation elements can have an elongated cylindrical shape with a circular cross-section. In some implementations, the coaptation elements can have an elliptical cross-sectional shape, an oval cross-sectional shape, a crescent cross-sectional shape, a rectangular cross-sectional shape, or various other non-cylindrical shapes. In some implementations, the coaptation elements can have an atrial portion positioned in or near the atrium, a ventricular or lower portion positioned in or near the ventricle, and lateral sides extending between the native tricuspid valve leaflets. In some implementations configured for use with a tricuspid valve, the atrial or upper portion is positioned in or near the right atrium, the ventricular or lower portion is positioned in or near the right ventricle, and the lateral sides extend between the native tricuspid valve leaflets.

[0065] In some implementations, the anchor can be configured to secure the device to one or both of the native valve leaflets such that the coaptation element is positioned between two native leaflets. In some implementations configured for use with tricuspid valves, the anchor is configured to secure the device to one, two, or three of the tricuspid valve leaflets such that the coaptation element is positioned between three native leaflets. In some implementations, the anchor can attach to the coaptation element adjacent to the ventricular portion of the coaptation element. In some implementations, the anchor can be attached to a drive element, such as a shaft or drive wire, to which the coaptation element is also attached. In some implementations, the anchor and the coaptation element can be independently positioned relative to each other by separately moving each of the anchor and the coaptation element along the longitudinal axis of the drive element (e.g., drive shaft, drive rod, drive tube, drive wire, etc.). In some implementations, the anchor and the coaptation element can be simultaneously positioned by moving the anchor and the coaptation element together along the longitudinal axis of the drive element (e.g., shaft, drive wire, etc.). The anchors can be configured to lie behind the native valve leaflets when implanted such that the leaflets are gripped by the anchors.

[0066] The device or implant may be configured to be implanted via a delivery system or other means for delivery. The delivery system may include one or more of a guide / delivery sheath, a delivery catheter, a steerable catheter, an implant catheter, a tube, combinations thereof, and the like. The coaptation element 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 such that the anchor is initially radially expanded from a statically compressed coaptation element to create a gap between the coaptation element and the anchor. The native valve leaflet is then positioned in the gap. The coaptation element may radially expand to close the gap between the coaptation element and the anchor, capturing the leaflet between the coaptation element and the anchor. In some implementations, the anchor and coaptation element are optionally configured to self-expand. The implantation methods for various implementations may vary, and each implementation is discussed more fully below. Additional information regarding these and other delivery methods is described in U.S. Patent Nos. 6,279,949 and 6,279,949, 6,279,959, 6,279,965, 6,279,975, 6,279,985, and 6,279,985, each of which is incorporated herein by reference in its entirety for all purposes. These methods may, mutatis mutandis, be performed in live animals or in simulated experiments such as cadavers, cadaver hearts, or simulated experimental devices (e.g., simulated body parts, hearts, tissues, etc.).

[0067] The disclosed device or implant can be configured such that anchors are coupled to the valve leaflets to utilize tension from the natural axons to withstand the high contractile pressures that urge the device toward the left atrium. During diastole, the device can rely on compressive and retaining forces on the leaflets that are gripped by the anchors.

[0068] 8-15, a schematic representation of an implantable device or implant 100 (e.g., a prosthetic spacer device, a valve repair device, etc.) is shown in various stages of deployment. Device or implant 100 and other similar devices / implants are described in more detail in U.S. Patent Nos. 6,275,999; 6,275,999; and 6,275,999, the entireties of which are incorporated herein by reference. Device 100 may include any other features for an implantable device or implant described in this or the above-cited applications, and device 100 may be positioned to engage valve tissue (e.g., valve leaflets 20, 22, 30, 32, 34) as part of any suitable valve repair system (e.g., any valve repair system disclosed in this or the above-cited applications).

[0069] The device or implant 100 is deployed from a delivery system or other means for delivery 102. The delivery system 102 can comprise one or more of a catheter, a sheath, a guide catheter / delivery sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, etc. The device or implant 100 includes a bond or bond-forming portion 104 and an anchor portion 106.

[0070] In some implementations, the coaptation portion 104 of the device or implant 100 is adapted to be implanted between the leaflets of a native valve (e.g., a native mitral valve, a native tricuspid valve, etc.) and includes a coaptation element or means for coaptation 110 slidably attached to an actuation element 112 (e.g., a drive wire, drive shaft, drive tube, etc.). The anchor portion 106 includes one or more anchors 108 that are actuatable between open and closed states and can take various forms, such as paddles, gripping elements, or the like. Actuation of the actuation means or actuation element 112 opens and closes the anchor portion 106 of the device 100 to grip the native valve leaflets upon implantation. The actuation means or actuation element 112 (as well as other actuation means and actuation elements herein) can take a wide variety of different forms (e.g., wires, rods, shafts, tubes, screws, sutures, lines, strips, combinations thereof, etc.), can be made from a variety of different materials, and can have a variety of configurations. As an example, the drive element can be threaded such that when the drive element is rotated, the anchor portion 106 moves relative to the bond forming portion 104. Alternatively, the drive element can be unthreaded such that when the drive element 112 is pushed or pulled, the anchor portion 106 moves relative to the bond forming portion 104.

[0071] The anchor portion 106 and / or anchor of the device 100, in some implementations, includes an outer paddle 120 and an inner paddle 122 connected by portions 124, 126, 128 between the cap 114 and the means for bonding or bond-forming element 110. The portions 124, 126, 128 can be coupled and / or flexible to move between all positions described below. By interconnecting the outer paddle 120, inner paddle 122, bond-forming element 110, and cap 114 by portions 124, 126, and 128, the device can be constrained to the positions and movements shown herein.

[0072] In some implementations, the delivery system 102 includes a steerable catheter, an implant catheter, and a means for driving or drive element 112 (e.g., a drive wire, drive shaft, etc.), which may be configured to extend through a guide catheter / sheath (e.g., a transseptal sheath, etc.). In some implementations, the means for driving or drive element 112 extends through the delivery catheter and the means for driving or coaptation element 110 to a distal end (e.g., a cap 114 or other attachment portion of the distal connection portion of the anchor portion 106). Extending and retracting the drive element 112 increases and decreases the spacing, respectively, between the coaptation element 110 and the distal end of the device (e.g., the cap 114 or other attachment portion). In some implementations, the joint forming element 110 is removably attached, either directly or indirectly, to the delivery system 102 by a collar or other attachment element, whereby the means for actuation or actuation element 112 slides through the collar or other attachment element, and in some implementations, through the means for actuation or actuation element 110 when actuated, to open and close the paddles 120, 122 of the anchor portion 106 and / or anchor 108.

[0073] In some implementations, the anchor portion 106 and / or the anchor 108 can include an attachment portion or a gripping member. The illustrated gripping member can include a fastener 130 including a base or fixed arm 132, a movable arm 134, optional barbs, friction-enhancing elements, or other means for fastening 136 (e.g., protrusions, ridges, grooves, textured surfaces, adhesive, etc.), and a coupling portion 138. The fixed arm 132 is attached to the inner paddle 122. In some implementations, the fixed arm 132 is attached to the inner paddle 122, and the coupling portion 138 is disposed adjacent to the means for joining or the joint-forming element 110. In some implementations, the fastener (e.g., a barbed fastener, etc.) has a flat surface and does not fit into a recess in the inner paddle. Rather, the flat surface of the fastener is positioned against the surface of the inner paddle 122. The coupling 138 provides a spring force between the fixed arm 132 and the movable arm 134 of the fastener 130. The coupling 138 can be any suitable coupling, such as a flexible coupling, a spring coupling, a pivot coupling, or the like. In some implementations, the coupling 138 is a flexible piece of material formed integrally with the fixed arm 132 and the movable arm 134. The fixed arm 132 is attached to the inner paddle 122 and remains stationary or substantially stationary relative to the inner paddle 122 when the movable arm 134 is opened and the fastener 130 opens and returns, exposing the friction-enhancing element or means for securing 136.

[0074] In some implementations, the catch 130 is opened by applying tension to a drive line 116 attached to a movable arm 134, causing the movable arm 134 to articulate, bend, or pivot about a joint 138. The drive line 116 extends through the delivery system 102 (e.g., through a steerable catheter and / or an implant catheter). Other drive mechanisms are possible.

[0075] The drive line 116 can take a wide variety of forms, such as, for example, a line, suture, wire, rod, catheter, etc. The fasteners 130 can be spring loaded so that in the closed position, the fasteners 130 continuously exert a pinching force on the grasped native valve leaflets. This pinching force remains constant regardless of the position of the inner paddle 122. Optional barbs, friction-enhancing elements, or other means for fixation 136 on the fasteners 130 can grip, pinch, and / or pierce the native valve leaflets to further secure the native valve leaflets.

[0076] During implantation, the paddles 120, 122 can be opened and closed to grip native valve leaflets (e.g., native mitral valve leaflets) between the paddles 120, 122 and / or between the paddles 120, 122 and the means for coaptation or coaptation-forming element 110. The fasteners 130 can be used to grip and / or further secure the native valve leaflets by barbing the leaflets and engaging the friction-enhancing elements or means for fixation 136, and by clamping the leaflets between the movable arm 134 and the fixation arm 132. The barbs, friction-enhancing elements, or other means for fixation 136 (e.g., barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.) of the fasteners or barbed fasteners 130 can increase friction with or partially or completely perforate the leaflets. The drive lines 116 can be separately actuated, allowing each fastener 130 to open and close separately. The separate operation allows the leaflets to be grasped one at a time, or allows the barbs 130 of a poorly grasped leaflet to be repositioned without altering the successful grasp of the other leaflet. The catches 130 can be opened and closed relative to the position of the inner paddle 122 (as long as the inner paddle is in an open or at least partially open position), thereby allowing the leaflets to be grasped in a variety of states as needed for a particular situation.

[0077] Referring now to FIG. 8 , the device 100 is shown in an elongated, or fully open, state for deployment from an implant delivery catheter of a delivery system. The device 100 is disposed at the end of the catheter 102 in the fully open state because it takes up the least space, allowing for the use of the smallest catheter (or the largest device 100 for a given catheter size). In the elongated state, the cap 114 is spaced from the means for attachment or attachment-forming element 110 so that the paddles 120, 122 are fully extended. In some implementations, the angle formed between the inside of the outer paddle 120 and the inside of the inner paddle 122 is approximately 180 degrees. The catch 130 is held in a closed state during deployment by the delivery system 102, so that barbs, friction-enhancing elements, or other means for fixation 136 ( FIG. 9 ) do not snag or damage tissue in the delivery system 102 or the patient's heart. The drive line 116 extends around the collar 115 and through a coupler 117 and is attached to a movable arm 134 .

[0078] 9, device 100 is shown in an elongated and entangled state similar to that of FIG. 8, but with clasps 130 in a fully open position and ranging from about 140 degrees to about 200 degrees, from about 170 degrees to about 190 degrees, or about 180 degrees between fixed position 132 and movable position 134 of clasp 130. Fully opening paddles 120, 122 and clasps 130 has been found to improve the ease of disentanglement or detachment from a patient's anatomical structures, such as chordae tendineae CT, upon implantation of device 100.

[0079] Referring now to FIG. 10 , the device 100 is shown in a shortened, or fully closed, state. The compact size of the device 100 in the shortened state allows for easier manipulation and placement within the heart. To transition the device 100 from the elongated state to the shortened state, the means for actuation or drive element 112 is retracted, pulling the cap 114 toward the means for actuation or coaptation element 110. The connection 126 (e.g., bond, flexible connection, etc.) between the outer paddle 120 and the inner paddle 122 is constrained such that the compressive force exerted on the outer paddle 120 by the cap 114 being retracted toward the means for actuation or coaptation element 110 causes the paddle or gripping element to move radially outward. During movement from the open to the closed position, the outer paddle 120 maintains an acute angle with the means for actuation or drive element 112. The outer paddle 120 can optionally be biased toward the closed position. During the same movement, the inner paddle 122 moves through a significantly larger angle as it faces away from the means for joining or interface-forming element 110 in the open position and folds along the side of the means for joining or interface-forming element 110 in the closed position. In some implementations, the inner paddle 122 is thinner and / or narrower than the outer paddle 120, and the links 126, 128 (or bonds, flexible links, etc.) coupled to the inner paddle 122 can be thinner and / or more flexible. For example, this increased flexibility allows for greater movement than the link 124 connecting the outer paddle 120 to the cap 114. In some implementations, the outer paddle 120 is thinner than the inner paddle 122. The links 126, 128 coupled to the inner paddle 122 can be more flexible to allow for greater movement than the link 124 connecting the outer paddle 120 to the cap 114, for example. In some implementations, the inner paddle 122 can be the same width as, or substantially the same width as, the outer paddle.

[0080] 11-13, the device 100 is shown in a partially open, gripping-ready state. To move from the fully closed state to the partially open state, the actuating means or element (e.g., drive wire, drive shaft, etc.) is extended to push the cap 114 away from the coaptation means or coaptation-forming element 110, thereby pulling the outer paddle 120, which in turn pulls the inner paddle 122, causing the anchor or anchor portions 106 to partially unfold. The drive line 116 can also be pulled to open the catch 130, thereby gripping the valve leaflets. In some implementations, the pair of inner and outer paddles 122, 120 move in unison, rather than separately, with a single actuating means or single actuating element 112. Additionally, the position of the catch 130 depends on the position of the paddles 122, 120. For example, referring to FIG. 10, closing the paddles 122, 120 also closes the catch. In some implementations, the paddles 120, 122 may be independently controllable. For example, the device 100 may have two drive elements and two independent caps (or other mounting portions), with one independent drive element (e.g., a wire, shaft, etc.) and cap (or other mounting portion) used to control one paddle and the other independent drive element and cap (or other mounting portion) used to control the other paddle.

[0081] 12, one of the drive lines 116 is stretched, allowing one of the fasteners 130 to close. Referring now to FIG. 13, the other drive line 116 is stretched, allowing the other fastener 130 to close. Either or both of the drive lines 116 can be repeatedly driven to repeatedly open and close the fasteners 130.

[0082] 14, device 100 is shown in a fully closed, deployed state. The delivery system or means for delivering 102 and means for driving or drive element 112 are retracted, while paddles 120, 122 and catches 130 remain in the fully closed position. After deployment, device 100 can be maintained in the fully closed position by a mechanical latch, or can be biased to remain closed by using a spring material such as steel, other metals, plastics, composites, or shape memory alloys such as Nitinol. For example, the links 124, 126, 128, the couplings 138, and / or the inner and outer paddles 122, and / or additional biasing components (not shown) can be formed of a metal such as steel or a shape memory alloy such as Nitinol (produced as a wire, sheet, tube, or laser-sintered powder) and are biased to hold the outer paddle 120 closed around the coaptation means or coaptation-forming element 110 and to hold the fasteners 130 clamped around the native valve leaflets. Similarly, the fixed and movable arms 132, 134 of the fasteners 130 are biased to clamp the leaflets. In some implementations, the attachment or linking portions 124, 126, 128, the couplings 138, and / or the inner and outer paddles 122, 120 and / or additional biasing components (not shown) can be formed of a metal or any other suitable resilient material, such as a polymeric material, to maintain the device 100 in a closed state after implantation.

[0083] Figure 15 shows an example in which the paddles 120, 122 are independently controllable. The device 100 shown in Figure 15 is similar to the device shown in Figure 11, except that the device 100 of Figure 15 includes actuation elements configured as two independent actuation elements or drive wires 111, 113 coupled to two independent caps 115, 117. To move the first inner paddle 122 and the first outer paddle 120 from a fully closed state to an incompletely open state, the actuation means or actuation element 111 is extended to push the cap 115 away from the joint forming means or joint forming element 110, thereby pulling the outer paddle 120 and then the inner paddle 122, partially expanding the first anchor 108. To move the second inner paddle 122 and the second outer paddle 120 from the fully closed state to the partially open state, the means for driving or drive element 113 is extended to push the cap 115 away from the means for joining or bond-forming element 110, thereby pulling the outer paddle 120 and then the inner paddle 122, partially expanding the second anchor 108. The independent paddle control shown in FIG. 15 can be implemented in any of the devices disclosed by the present application. For comparison, in the example shown in FIG. 11, the pair of inner paddle 122 and outer paddle 120 move in unison rather than separately by a single means for driving or drive element 112.

[0084] 16-21, the implantable device 100 of FIGS. 8-14 is shown delivered and implanted into the native mitral valve MV of the heart H. Referring to FIG. 16, a delivery sheath / catheter 142 is inserted through the septum into the left atrium LA. The delivery sheath / catheter 142 includes a steerable catheter 140, an implant catheter 103, and an implant / device 100. In one exemplary implementation, the implant / device 100 is adjacent to the end of the steerable catheter 140 inside the delivery sheath / catheter 142, and the implant catheter 103 is inside the steerable catheter 140. The delivery sheath / catheter 142 and / or the implant catheter 103 may optionally be steerable. In one exemplary implementation, the delivery sheath / catheter 142 and / or the steerable catheter 140 are steerable, but the implant catheter 103 is passive or not steerable (except as a result of following the path of the steerable catheter).

[0085] Once the delivery sheath / catheter 142 is in the left atrium, the implant / device 100 is deployed from the delivery catheter / sheath 142 in a fully open position, as illustrated in Figure 16. The means for actuation or actuation element 112 is then retracted, thereby moving the implant / device 100 to a fully closed position, as shown in Figure 17.

[0086] As can be seen in Figure 18, the implant / device 100 is placed in position within the mitral valve MV into the ventricle LV and partially opens, thereby grasping the valve leaflets 20, 22. For example, as illustrated by Figure 18, the steerable catheter 140 can be advanced and steered or bent to position the steerable catheter 140. An implant catheter 102 coupled to the implant / device 100 can be advanced from inside the steerable catheter 140 (as indicated by arrow 105) to position the implant as illustrated by Figure 18.

[0087] 19, the implant catheter 103 can be retracted into the steerable catheter 140 (as indicated by arrow 107), positioning the mitral valve leaflets 20, 22 within the clasps 130 of the implant / device 100. The drive line 116 is extended to close one of the clasps 130, thereby capturing the leaflet 20. FIG. 20 shows the other drive line 116, which is then extended to close the other clasp 130, thereby capturing the remaining leaflet 22. Finally, as seen in FIG. 21, the delivery system 102 (e.g., steerable catheter 140, implant catheter 103, etc.), actuation means or drive element 112, and drive line 116 are then retracted, fully closing and deploying the implant / device 100 within the native mitral valve MV.

[0088] 22-27, an example of an implantable device or implant 200 is shown. The implantable device 200 is one of many different forms that the device 100, shown generally in FIGS. 8-14, can take. The device 200 can include any other features of the implantable devices or implants discussed herein, and the device 200 can be positioned to engage valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein). The device / implant 200 can be a prosthetic spacer device, a valve repair device, or other type of implant that attaches to the leaflets of a native valve.

[0089] In some embodiments, the implantable device or implant 200 comprises a coaptation or coaptation-forming portion 204, a proximal or attachment portion 205, an anchor portion 206, and a distal portion 207. In some embodiments, the coaptation or coaptation-forming portion 204 of the device optionally comprises a coaptation-forming element 210 (e.g., a spacer, coaptation element, plug, membrane, sheet, etc.) for implantation between the leaflets of the native valve. In some embodiments, the anchor portion 206 includes multiple anchors 208. The anchors can be configured in various ways. In some embodiments, each anchor 208 comprises an outer paddle 220, an inner paddle 222, a paddle extension or paddle frame 224, and a fastener 230. In some embodiments, the attachment portion 205 comprises a first or proximal collar 211 (or other attachment element) for engaging a capture mechanism 213 ( FIGS. 43-49 ) of a delivery system ( FIGS. 38-42 and 49 ). The delivery system may be the same as or similar to delivery system 102 described elsewhere and may comprise one or more of a catheter, a sheath, a guide catheter / delivery sheath, a delivery catheter / sheath, a steerable catheter, an implant catheter, a tube, a channel, a pathway, combinations thereof, or the like.

[0090] In some implementations, the bond-forming element 210 and paddles 220, 222 can be formed from a flexible material, which can be a metal fabric, such as a woven, knitted, or any other suitable formed mesh, or a laser-cut or otherwise cut flexible material, which can also be a cloth, a shape-memory alloy wire (such as Nitinol) for shape-setting functionality, or any other flexible material suitable for implantation in the human body.

[0091] A drive element 212 (e.g., drive shaft, drive rod, drive tube, drive wire, drive line, etc.) extends from an implant catheter 241 ( FIGS. 38-42 ) of the delivery system to engage and enable actuation of the implantable device or implant 200. In some implementations, the drive element 212 extends through the capture mechanism 213, the proximal collar 211, and the interface-forming element 210 to engage with a cap 214 on the distal portion 207. The drive element 212 can be configured to releasably engage with the cap 214 via a threaded connection or similar means, allowing the drive element 212 to be disengaged and removed from the device 200 after implantation.

[0092] The joint-forming element 210 extends from the proximal collar 211 (or other attachment element) to the inner paddle 222. In some implementations, the joint-forming element 210 has a generally elongated, rounded shape, although other shapes and configurations are possible. In some implementations, the joint-forming element 210 has an oval shape or cross-section when viewed from above (e.g., FIG. 51), a tapered shape or cross-section when viewed from the front (e.g., FIG. 23), or a rounded shape or cross-section when viewed from the side (e.g., FIG. 24). A mixture of these three geometries can result in the illustrated three-dimensional shape of the joint-forming element 210 achieving the benefits described herein. It can be seen that the rounded shape of the joint-forming element 210 also substantially follows or approximates the shape of the paddle frame 224 when viewed from above.

[0093] The size and / or shape of the coaptation element 210 can be selected to minimize the number of implants required per patient (preferably one) while simultaneously maintaining a low transvalvular gradient. In some implementations, the anterior-posterior distance of the top of the coaptation element is about 5 mm, and the central lateral distance of the coaptation element at its widest point is about 10 mm. In some implementations, the overall geometry of the device 200 can be based on these two dimensions and the overall shape strategies described above. It should be readily apparent that using different anterior-posterior and central lateral distances as a starting point for the device will result in devices with different dimensions. Furthermore, using other dimensions and the shape strategies described above will also result in devices with different dimensions.

[0094] In some implementations, outer paddle 220 is seamably attached to cap 214 of distal portion 207 by link 221 and to inner paddle 222 by link 223. Inner paddle 222 is seamably attached to the joint-forming element by link 225. In this manner, anchor 208 is configured similar to a leg, in that inner paddle 222 resembles the upper part of a leg, outer paddle 220 resembles the lower part of a leg, and link 223 resembles the knee of the leg.

[0095] In some implementations, the inner paddle 222 is stiff, relatively stiff, rigid, has a rigid portion, and / or is stiffened by a fastener 232 of a stiffening member or fastener 230. Stiffening the inner paddle allows the device to move to a variety of different positions as shown and described herein. The inner paddle 222, outer paddle 220, and bonding formations can all be interconnected as described herein such that the device 200 is constrained to the movements and positions shown and described herein.

[0096] In some implementations, the paddle frame 224 is attached to the cap 214 at the distal portion 207 and extends to the connection 223 between the inner paddle 222 and the outer paddle 220. In some implementations, the paddle frame 224 is formed from a material that is stiffer and more rigid than the material forming the paddles 222, 220, such that the paddle frame 224 provides support for the paddles 222, 220.

[0097] The paddle frame 224, as seen in FIG. 51 , provides additional pinching force between the inner paddle 222 and the coaptation element 210, helping to wrap the leaflets around the sides of the coaptation element 210 for a better seal between the coaptation element 210 and the leaflets. That is, the paddle frame 224 can be configured with a rounded, three-dimensional shape and extend from the cap 214 to the linkage 223 of the anchor 208. The linkages between each paddle frame 224, the outer and inner paddles 220 and 222, the cap 214, and the coaptation element 210 can constrain each of these parts to the movements and positions described herein. In particular, the linkage 223 is constrained by its connection between the outer and inner paddles 220 and 222 and by its connection to the paddle frame 224. Similarly, the paddle frame 224 is constrained by the linkage 223 (and thus the inner paddle 222 and outer paddle 220 ) and its attachment to the cap 214 .

[0098] Configuring the paddle frame 224 in this manner provides an increased surface area compared to the outer paddles 220 alone. This increased surface area facilitates gripping and securing the native valve leaflets. The increased surface area also allows the clamping force of the paddles 220 and paddle frame 224 against the native valve leaflets to be distributed over a larger area of ​​the native valve leaflets to further protect the native leaflet tissue. Referring again to FIG. 51 , the increased surface area of ​​the paddle frame 224 may also allow the native valve leaflets to be secured to the implantable device or implant 200 such that the native leaflets coapt entirely around the coaptation members or elements 210. This may, for example, improve sealing of the native valve leaflets 20, 22, thereby preventing or further reducing mitral regurgitation.

[0099] In some implementations, the fastener comprises a movable arm coupled to the anchor. In some implementations, the fastener 230 includes a base or fixed arm 232, a movable arm 234, a barb 236, and a coupling portion 238. The fixed arm 232 is attached to the inner paddle 222, and the coupling portion 238 is disposed adjacent to the joint-forming element 210. The coupling portion 238 is spring-loaded, such that the fixed arm 232 and the movable arm 234 are biased toward each other when the fastener 230 is in the closed state. In some implementations, the fastener 230 comprises friction-enhancing elements or means for fastening, such as barbs, protrusions, ridges, grooves, textured surfaces, adhesives, etc.

[0100] In some implementations, the fixed arm 232 is attached to the inner paddle 222 with a suture (not shown) through a hole or slot 231. The fixed arm 232 can be attached to the inner paddle 222 by any suitable means, such as a screw or other fastener, a locking sleeve, a mechanical catch or hook, a weld, an adhesive, a clamp, a hasp, etc. The fixed arm 232 remains substantially fixed relative to the inner paddle 222 when the movable arm 234 is opened and the catch 230 opens, exposing the barb or other friction-enhancing element 236. The catch 230 is opened by applying tension to the drive line 216 (e.g., as shown in FIGS. 43-48 ) attached to the hole 235 in the movable arm 234, causing the movable arm 234 to articulate, pivot, and / or bend on the joint 238.

[0101] 29 , a close-up view of one of the leaflets 20, 22 grasped by a fastener, such as fastener 230, is shown. The leaflets 20, 22 are grasped between the movable and fixed arms 234 of the fastener 230. The tissue of the leaflets 20, 22 is not perforated by the barbs or frictional augmenting elements 236, although in some implementations, the barbs 236 may partially or completely perforate the leaflets 20, 22. The angle and height of the barbs or frictional augmenting elements 236 relative to the movable arms 234 aids in securing the leaflets 20, 22 within the fastener 230. In particular, the force pulling the implant away from the native leaflets 20, 22 encourages the barbs or frictional augmenting elements 236 to further engage the tissue, thereby ensuring a better retention. Retention of the leaflets 20, 22 on the barbs 230 is further improved by positioning the anchoring arms 232 near the barbs / friction-enhancing elements 236 when the fasteners 230 are closed. In this arrangement, the tissue is forced into an S-shaped, serpentine path by the anchoring arms 232, the movable arms 234, and the barbs / friction-enhancing elements 236. Thus, the force pulling the leaflets 20, 22 away from the fasteners 230 encourages the tissue to further engage the barbs / friction-enhancing elements 236 before the leaflets 20, 22 can escape. For example, leaflet tension during diastole may encourage the barbs 236 to be pulled toward the end portions of the leaflets 20, 22. Thus, the S-shaped path allows leaflet tension during diastole to be utilized to more tightly engage the leaflets 20, 22 with the barbs / friction-enhancing elements 236.

[0102] 25 , the prosthetic device or implant 200 may also include a cover 240. In some implementations, the cover 240 may be disposed on the joint-forming element 210, the outer and inner paddles 220, 222, and / or the paddle frame 224. The cover 240 may be configured to prevent or reduce blood flow through the prosthetic device or implant 200 and / or to promote natural tissue ingrowth. In some implementations, the cover 240 may be a cloth or fabric such as PET, velour, or other suitable fabric. In some implementations, instead of or in addition to a fabric, the cover 240 may include a coating (e.g., a polymer) applied to the implantable prosthetic device or implant 200.

[0103] During implantation, the paddles 220, 222 of the anchor 208 are opened and closed to grip the native valve leaflets 20, 22 between the paddles 220, 222 and the coaptation element 210. The anchor 208 is moved between a closed position ( FIGS. 22-25 ) and various open positions ( FIGS. 26-37 ) by extending and retracting the actuation element 212. Extending and retracting the actuation element 212 increases and decreases the spacing between the coaptation element 210 and the cap 214, respectively. The proximal collar 211 (or other attachment element) and the coaptation element 210 slide along the actuation element 212 during actuation, thereby changing the spacing between the coaptation element 210 and the cap 214 and moving the paddles 220, 220 between different positions to grip the native valve leaflets 20, 22 during implantation.

[0104] When device 200 is opened or closed, the pair of inner and outer paddles 222, 220 move in unison, rather than independently, via a single actuation element 212. Also, the position of catch 230 depends on the positions of paddles 222, 220. For example, catch 230 is positioned such that catch 230 closes at the same time that anchor 208 closes. In some implementations, device 200 can be fabricated such that paddles 220, 222 are similarly independently controllable (e.g., device 100 illustrated in FIG. 15 ).

[0105] In some implementations, the fasteners 230 further secure the native valve leaflets 20, 22 by engaging the leaflets 20, 22 with barbs and / or other friction-enhancing elements 236 and by sandwiching the leaflets 20, 22 between the movable arm 234 and the fixed arm 232. In some implementations, the fasteners 230 are barbed fasteners with barbs that increase friction with the leaflets 20, 22 and / or can partially or fully pierce the leaflets 20, 22. The drive lines 216 ( FIGS. 43-48 ) can be actuated separately, allowing each fastener 230 to open and close separately. Separate actuation allows the leaflets 20, 22 to be grasped one at a time, or allows the fastener 230 on a poorly grasped leaflet 20, 22 to be repositioned without altering the successful grasp of the other leaflet 20, 22. The catches 230 can be fully opened and closed when the inner paddle 222 is not closed, thereby allowing the leaflets 20, 22 to be gripped in various positions as required by a particular situation.

[0106] 22-25, the device 200 is shown in a closed configuration. When closed, the inner paddle 222 is positioned between the outer paddle 220 and the coaptation element 210. A catch 230 is disposed between the inner paddle 222 and the coaptation element 210. Upon successful capture of the native leaflets 20, 22, the leaflets 20, 22 are secured within the device 200 by the catch 230, and the device 200 is moved to and held in a closed position such that the paddles 220, 222 press the leaflets 20, 22 against the coaptation element 210. The outer paddle 220 may have a wider, curved shape to fit around the curved coaptation element 210 to more securely grip the leaflets 20, 22 when the device 200 is closed (e.g., as seen in FIG. 51 ). The curved shape and rounded edges of the outer paddle 220 also prevent or inhibit tearing of the leaflet tissue.

[0107] 30-37, the implantable device or implant 200 described above is shown in various positions and configurations, ranging from a partially open position to a fully open position. The paddles 220, 222 of the device 200 transition between the closed position shown in FIGS. 22-25 and each of the positions shown in FIGS. 30-37 after the drive element 212 is extended from a fully retracted position to a fully extended position.

[0108] 30-31, the device 200 is shown in a partially open state. The device 200 is moved to the partially open position by extending the drive element 212. Extending the drive element 212 pulls down the bottom of the outer paddle 220 and paddle frame 224. The outer paddle 220 and paddle frame 224 pull down the inner paddle 222, which is coupled to the outer paddle 220 and paddle frame 224. Because the proximal collar 212 (or other attachment element) and the interface-forming element 210 are held in place by the capture mechanism 213, the inner paddle 222 articulates, pivots, and / or bends in the open direction. The inner paddle 222, outer paddle 220, and paddle frame all bend to the state shown in FIGS. 30-31. Opening the paddles 222, 220 and frame 224 creates a gap between the coaptation element 210 and the inner paddle 222 to receive and grip the native leaflets 20, 22. This movement also exposes a catch 230 that can move between a closed position ( FIG. 30 ) and an open position ( FIG. 31 ) to form a second gap for gripping the native leaflets 20, 22. The expansion of the gap between the fixed arm 232 and the movable arm 234 of the catch 230 is limited to the extent that the inner paddle 222 expands away from the coaptation element 210.

[0109] 32-33, device 200 is shown in a laterally extended, or open, state. Device 200 is transitioned to the laterally extended, or open, state by continuing to extend actuation element 212, described above, thereby increasing the distance between joint-forming element 210 and cap 214 of distal portion 207. Continued extension of actuation element 212 pulls outer paddle 220 and paddle frame 224 downward, thereby further opening inner paddle 222 away from joint-forming element 210. In the laterally extended, or open, state, inner paddle 222 extends horizontally to a greater extent than in other states of device 200, forming an angle of approximately 90 degrees relative to joint-forming element 210. Similarly, paddle frame 224 is in its maximum extended state when device 200 is in the laterally extended, or open, state. The increased gap between the joint-forming element 210 and the inner paddle 222 in the laterally stretched, i.e., open, state allows the fastener 530 to open further before the fastener 230 engages the joint-forming element 210 (FIG. 33), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0110] 34-35 , the exemplary device 200 is shown in a three-quarters extended position. The device 200 is moved to the three-quarters extended position by continuing to extend the drive element 212, as described above, thereby increasing the distance between the joint-forming element 210 and the cap 214 of the distal portion 207. Continued extension of the drive element 212 pulls the outer paddle 220 and paddle frame 224 downward, thereby further opening the inner paddle 222 away from the joint-forming element 210. In the three-quarters extended position, the inner paddle 222 opens beyond 90 degrees to approximately 135 degrees relative to the joint-forming element 210. The paddle frame 224 is less spread apart laterally than in the extended, or open, position and begins to move inward toward the drive element 212 as the drive element 212 is further extended. The outer paddle 220 also bends back toward the drive element 212. Similar to the laterally stretched or open state, the increased gap between the joint-forming element 210 and the inner paddle 222 formed in the laterally stretched or open state allows the fastener 230 to open even further (FIG. 35), thereby increasing the size of the gap between the fixed arm 232 and the movable arm 234.

[0111] 36-37 , an exemplary device 200 is shown in a fully extended state. The device 200 is moved to the fully extended position by continuing to extend the drive element 212, as described above, thereby increasing the distance between the joint-forming element 210 and the cap 214 of the distal portion 207 to the maximum distance allowable by the device 200. Continued extension of the drive element 212 pulls the outer paddle 220 and paddle frame 224 down, causing the inner paddle 222 to further spread apart from the joint-forming element 210. The outer paddle 220 and paddle frame 224 move closer to the drive element. In the fully extended state, the inner paddle 222 is open to approximately 180 degrees relative to the joint-forming element 210. The inner paddle 222 and outer paddle 220 are straightened out in the fully extended state, forming an approximately 180-degree angle between the paddles 222, 220. The fully extended state of the device 200 provides the maximum size of the gap between the coaptation element 210 and the inner paddle 222, and in some implementations, the catch 230 is also allowed to fully open to approximately 180 degrees ( FIG. 37 ) between the fixed arm 232 and the movable arm 234 of the catch 230. This state of the device 200 provides the longest and thinnest configuration. That is, the fully extended state of the device 200 may be the desired state for expelling the device 200 from an attempted implantation or for loading the device into a delivery catheter.

[0112] Configuring the prosthetic device or implant 200 so that the anchor 208 can extend to a straight or substantially straight configuration (e.g., approximately 120-180 degrees relative to the coaptation forming element 210) can provide several advantages. For example, this configuration can reduce the radial pleat profile of the prosthetic device or implant 200. It can also facilitate grasping the native valve leaflets 20, 22 by providing a larger opening between the coaptation forming element 210 and the inner paddle 222 for grasping the native valve leaflets 20, 22. Additionally, the relatively slim, straight configuration can prevent or reduce the likelihood of the prosthetic device or implant 200 becoming entangled with natural anatomical structures (e.g., the chordae tendineae CT shown in FIGS. 3 and 4 ) when the prosthetic device or implant 200 is placed in and / or retrieved from the delivery system 202.

[0113] 38-49, an exemplary implantable device 200 is shown delivered and implanted within a native valve (e.g., mitral valve MV) of heart H. As described above, device 200 shown in FIGS. 38-49 includes coaptation elements 210, fasteners 230, and an optional cover 240 (e.g., FIG. 25) covering inner paddle 222 and / or outer paddle 220. Device 200 is deployed from a delivery system (which may include, e.g., a steerable catheter 241 and / or an implant catheter 203 extendable from a delivery catheter / sheath 242). A capture mechanism 213 is attached to the distal end of implant catheter 202. Device 200 is held by capture mechanism 213 (see, e.g., FIGS. 43 and 48) and can be actuated by extending or retracting actuation element 212. Fingers of capture mechanism 213 removably attach collar 211 to the delivery system. In some implementations, the capture mechanism 213 is held closed around the collar 212 by the drive element 211, such that after the device 200 is successfully implanted, the drive element 211 can be removed to allow the fingers of the capture mechanism 213 to open and release the collar 212, decoupling the capture mechanism 213 from the device 200.

[0114] 38, a delivery system (e.g., its delivery catheter / sheath 242) is inserted through the septum into the left atrium LA, and the device / implant 200 is deployed from the delivery system in a fully open state for the reasons described above with respect to device 100 (e.g., the implant catheter 203 holding the device / implant 200 is extended to allow the device / implant 200 to be deployed from the steerable catheter 241). The actuation element 212 is then retracted, moving the device 200 through a partially closed state (FIG. 39) to the fully closed state shown in FIGS. 40-41. The delivery system or catheter then steers the device / implant 200 toward the native valve, as shown in FIG. 41. 42, once the device 200 is aligned with the native valve, the drive element 212 is extended to open the paddles 220, 222 to a partially open position, and the drive line 216 (FIGS. 43-48) is retracted to open the catch 230 in preparation for leaflet grasping. The partially open device 200 is then inserted through the native valve (e.g., by advancing the implant catheter 203 from the steerable catheter 241) until the leaflets 20, 22 are properly positioned between the inner paddle 222 and the coaptation element 210 and within the open catch 230, as shown in FIG. 43-44.

[0115] FIG. 45 shows the device 200 with both fasteners 230 closed, but the barb 236 of one fastener 230 has missed one of the leaflets 22. As can be seen in FIGS. 45-47, the out-of-place fastener 230 can be reopened and re-opened to properly grasp the missed leaflet 22. Once both leaflets 20, 22 are properly grasped, the actuating element 212 is retracted, and the device 200 moves to the fully closed position shown in FIG. 48. As shown in FIG. 49, with the device 200 fully closed and implanted within the native valve, the actuating element 212 is disengaged from the cap 214 and withdrawn, releasing the capture mechanism 213 from the proximal collar 211 (or other attachment element), so that the capture mechanism 211 can be retracted into a delivery system (e.g., a steerable catheter 241 and / or a delivery catheter / sheath 242). Once deployed, the device 200 can be maintained in a fully closed position using mechanical means such as latches, or can be biased closed using a spring material such as steel and / or a shape memory alloy such as Nitinol. For example, the paddles 220, 222 can be formed of steel or Nitinol shape memory alloy (produced as a wire, sheet, tube, or laser-sintered powder), and the paddles are also biased to hold the outer paddle 220 closed around the inner paddle 222, the coaptation forming element 210, and / or the catches 230 clamped around the native valve leaflets 20, 22.

[0116] 50-54 , after the device 200 is implanted within the native valve, the coaptation element 210 functions as a gap filler for a valve regurgitation opening, such as the gap 26 in the mitral valve MV shown in FIG. 6 or another native valve gap. In some implementations, when the device 200 is deployed between two opposing valve leaflets 20, 22, the leaflets 20, 22 no longer coapt with each other within the region of the coaptation element 210 but instead coapt to the coaptation element 210. This reduces the distance the leaflets 20, 22 must approximate to close the mitral valve MV during systole, thereby facilitating treatment of functional valve disease that may contribute to mitral regurgitation. The reduced leaflet proximity may also result in several other benefits. For example, reducing the required proximity of the leaflets 20, 22 reduces or minimizes stress on the native valve. The closer the leaflets 20, 22 are to each other, the less approximation force may be required, resulting in less tension on the leaflets 20, 22 and less reduction in the diameter of the annulus. Less or no annular reduction may result in less reduction in valve orifice area compared to a device without a coaptation element or spacer. In this way, the coaptation element 210 may reduce the transvalvular gradient.

[0117] To adequately fill the gap 26 between the leaflets 20, 22, the device 200 and its components can have a wide variety of different shapes and sizes. For example, the outer paddle 220 and paddle frame 224 can be configured to fit the shape or geometry of the coaptation element 210, as shown in FIGS. 50-54 . As a result, the outer paddle 220 and paddle frame 224 can fit both the coaptation element 210 and the native leaflets 20, 22. In some implementations, when the leaflets 20, 22 are coapted to the coaptation element 210, the leaflets 20, 22 completely surround or "embrace" the coaptation element 210 in its entirety, thus preventing small amounts of leakage from the lateral surfaces 201 and the central surface 203 of the coaptation element 210. The interaction of the leaflets 20, 22 with the device 200 is made clear in Figure 51, which shows a schematic atrial or surgical view showing a paddle frame 224 (which would not actually be visible from a true atrial view, e.g., Figure 52) that conforms to the geometry of the coaptation element 210. The opposing leaflets 20, 22 (whose ends would also not be visible in a true atrial view, e.g., Figure 52) brought together by the paddle frame 224 completely surround or "embrace" the coaptation element 210.

[0118] This coaptation of the leaflets 20, 22 against the lateral and medial surfaces 201, 203 of the coaptation element 210 (shown from the atrial side in FIG. 52 and the ventricular side in FIG. 53) appears to contradict what was stated above about the proximity that the leaflets must occupy is minimized by the presence of the coaptation element 210. However, the proximity that the leaflets 20, 22 must occupy is still minimized when the coaptation element 210 is precisely positioned in the regurgitation gap 26, and the regurgitation gap 26 is smaller than the width (medial-lateral) of the coaptation element 210.

[0119] FIG. 50 illustrates the geometry of the coaptation element 210 and paddle frame 224 from an LVOT perspective. As can be seen in this figure, the coaptation element 210 has a tapered shape that is smaller in size near the area where the inner surfaces of the leaflets 20, 22 need to coapt and increases in size as the coaptation element 210 extends toward the atrium. Thus, the illustrated geometry of the native valve is accommodated by the tapered coaptation element geometry. Still referring to FIG. 50, the tapered coaptation element geometry, along with the illustrated expanding (toward the annulus) paddle frame 224 shape, can help achieve coaptation to the lower ends of the leaflets, reduce stress, and minimize transvalvular gradients.

[0120] 54, the shapes of the coaptation element 210 and paddle frame 224 can be defined based on the native valve and the commissure view of the device 210. Two elements of these shapes are leaflet coaptation to the coaptation element 210 and the reduction of stress on the leaflets due to coaptation. Referring to FIGS. 54 and 24, the coaptation element 210 can have a round or rounded shape and the paddle frame 224 can have a full radius that spans nearly the entire paddle frame 224 to coapt both leaflets 20, 22 to the coaptation element 210 and reduce stress applied to the leaflets 20, 22 by the coaptation element 210 and / or paddle 224. The round shape of the coaptation element 210 and / or the illustrated fully rounded shape of the paddle frame distributes stress on the leaflets 20, 22 over a wide, curved engagement area 205. For example, in FIG. 54, as the leaflets 20 attempt to open during the diastolic cycle, the force applied by the paddle frame to the leaflets 20, 22 is spread along the entire rounded length of the paddle frame 224.

[0121] 55, an example of an implantable prosthetic device or implant 300 is shown. The implantable device 300 is one of many different forms that the device 100 shown generally in FIGS. 8-14 can take. The device 300 can include any other features of the implantable devices or implants discussed herein, and the device 300 can be positioned to engage the valve tissue 20, 22 as part of any suitable valve repair system (e.g., any of the valve repair systems disclosed herein).

[0122] The implantable device or implant 300 comprises a proximal or attachment portion 305, an anchor portion 306, and a distal portion 307. In some implementations, the device / implant 300 comprises a coaptation forming portion 304, which optionally includes a coaptation forming element 310 (e.g., a spacer, plug, membrane, sheet, etc.) for implantation between the leaflets 20, 22 of the native valve. In some implementations, the anchor portion 306 includes multiple anchors 308. In some implementations, each anchor 308 comprises one or more paddles, e.g., an outer paddle 320, an inner paddle 322, and a paddle extension or paddle frame 324. The anchors may also comprise and / or be coupled to fasteners 330. In some implementations, the attachment portion 305 includes a first or proximal collar 311 (or other attachment element) for engaging with a capture mechanism (e.g., a capture mechanism such as capture mechanism 213 shown in Figures 43-49) of a delivery system (e.g., a delivery system such as the delivery systems shown in Figures 38-42 and 49).

[0123] The anchors 308 may be attached to other portions of the device and / or to each other in a variety of different ways (e.g., directly, indirectly, by welding, by stitching, by adhesive, by linking, by latching, by integral formation, by some or all combinations thereof, etc.) In some implementations, the anchors 308 are attached to the bond-forming member or element 310 by a connection 325 and to the cap 314 by a connection 321.

[0124] Anchor 308 can include a first or outer paddle 320 and a second or inner paddle 322 separated by a linkage 323. Linkage 323 can be attached to a paddle frame 324 that is hingedly attached to cap 314 or other mounting portion. In this manner, anchor 308 is configured similar to a leg, in that inner paddle 322 resembles the top of a leg, outer paddle 320 resembles the bottom of a leg, and linkage 323 resembles the knee of the leg.

[0125] In implementations having a bond-forming member or element 310, the bond-forming member or element 310 and anchor 308 can be coupled together in a variety of ways. For example, as shown in the illustrated implementation, the bond-forming element 310 and anchor 308 can be coupled by integrally forming the bond-forming element 310 and anchor 308 as a single, unitary component. This can be achieved, for example, by forming the bond-forming element 310 and anchor 308 from a continuous strip 301 of braided or woven material, such as braided or woven nitinol wire. In the illustrated example, the bond-forming element 310, outer paddle portion 320, inner paddle portion 322, and linking portions 321, 323, 325 are formed from a continuous strip 301 of fabric.

[0126] Similar to the anchor 208 of the implantable device or implant 200 described above, the anchor 308 may be configured to move between various configurations by axially moving the distal end of the device (e.g., cap 314, etc.) relative to the proximal end of the device (e.g., proximal collar 311 or other attachment element, etc.), such that the anchor 308 moves relative to the midpoint of the device. This movement may be along a longitudinal axis extending between the distal end (e.g., cap 314, etc.) and the proximal end (e.g., collar 311 or other attachment element, etc.) of the device. For example, the anchor 308 may be positioned in a fully extended, or straight, configuration (e.g., similar to the configuration of the device 200 shown in FIG. 36 ) by moving the distal end (e.g., cap 314, etc.) away from the proximal end of the device.

[0127] In some implementations, in the straight configuration, the paddle portions 320, 322 are aligned or straight along the longitudinal axis of the device. In some implementations, the bond portion 323 of the anchor 308 is adjacent to the longitudinal axis of the joint-forming element 310 (e.g., similar to the configuration of device 200 shown in FIG. 36). From the straight configuration, the anchor 308 can be moved to a fully collapsed configuration (e.g., FIG. 55), for example, by moving the proximal and distal ends toward each other and / or toward the midpoint or center of the device. Initially, as the distal end (e.g., cap 314, etc.) moves toward the proximal end and / or midpoint or center of the device, anchor 308 bends at links 321, 323, 325, and link 323 moves radially outward relative to the longitudinal axis of device 300 and axially toward the midpoint and / or proximal end of the device (e.g., similar to the configuration of device 200 shown in FIG. 34). As cap 314 continues to move toward the midpoint and / or proximal end of the device, link 323 moves radially inward relative to the longitudinal axis of device 300 and axially toward the proximal end of the device (similar to the configuration of device 200 shown in FIG. 30).

[0128] In some implementations, the fastener comprises a movable arm coupled to the anchor. In some implementations, fastener 330 (as shown in detail in FIG. 56 ) includes a base or fixed arm 332, a movable arm 334, an optional barb / friction-enhancing element 336, and a coupling portion 338. Fixed arm 332 is attached to inner paddle 322, and coupling portion 338 is positioned adjacent to interface-forming element 310. Coupling portion 338 is spring-loaded such that fixed arm 332 and movable arm 334 are biased toward each other when fastener 330 is in a closed state.

[0129] The fixed arm 332 is attached to the inner paddle 322 with sutures (not shown) through holes or slots 331. The fixed arm 332 may be attached to the inner paddle 322 by any suitable means, such as screws or other fasteners, a locking sleeve, a mechanical latch or clasp, welding, adhesives, etc. The fixed arm 332 remains substantially fixed relative to the inner paddle 322 when the movable arm 334 is opened and the clasp 330 opens, exposing the barb 336. The clasp 330 is opened by applying tension to a drive line (e.g., drive line 216 shown in FIGS. 43-48 ) attached to the hole 335 in the movable arm 334, which causes the movable arm 334 to articulate, pivot, and / or bend on the joint 338.

[0130] In summary, the implantable device or implant 300 is similar in construction and operation to the implantable device or implant 200 described above, except that the joint-forming element 310, outer paddle 320, inner paddle 322, and links 321, 323, 325 are formed from a single strip of material 301. In some implementations, the strip of material 301 is attached to the proximal collar 311, cap 314, and paddle frame 324 by weaving or inserting it through openings in the proximal collar 311, cap 314, and paddle frame 324 that are configured to receive the continuous strip of material 301. The continuous strip 301 can be a single layer of material or can include two or more layers. In some implementations, one portion of the device 300 has a single layer of the strip of material 301, while another portion is formed from multiple overlapping or overlying layers of the strip of material 301.

[0131] For example, Figure 55 shows a bond-forming element 310 and inner paddle 322 formed from multiple overlapping layers of strip of material 301. The single continuous strip of material 301 may begin and end at various locations on the device 300. The ends of the strip of material 301 may be at the same location or at different locations on the device 300. For example, in the illustrated example of Figure 55, the strip of material 301 begins and ends at the location of the inner paddle 322.

[0132] Similar to the implantable device or implant 200 described above, the size of the coaptation element 310 may be selected to minimize the number of implants required per patient (preferably one) while simultaneously maintaining a low transvalvular gradient. In particular, by forming multiple components of the device 300 from a strip of material 301, the device 300 can be made smaller than the device 200. For example, in some implementations, the anterior-posterior distance of the apex of the coaptation element 310 is less than 2 mm, and the medial lateral distance of the device 300 at its widest point (the width of the paddle frame 324, which is wider than the coaptation element 310) is about 5 mm.

[0133] 57-65B illustrate exemplary implementations of implant catheters that may be used as the implant catheters 103, 203 described above. As illustrated in FIGS. 16-20 and 38-49, the implant catheters 103, 203 can enter the right atrium from the IVC or SVC, and optionally from the right atrium to the left atrium. The implant catheters 103, 203 can be bent downward to properly position the implantable prosthetic device 100, 200. In one exemplary implementation, the implant catheter 103 is enclosed within a steerable catheter 140, which is itself enclosed within a guide sheath 142, as described above. Similarly, the implant catheter 203 is enclosed within a steerable catheter 241, which is itself enclosed within a guide sheath 242, as described above. To resist compression along its length while being flexible enough to form the bends illustrated in Figures 18, 41, and 42, a catheter is required that has portions that are incompressible but flexible.

[0134] FIG. 57 illustrates a cross section of such a flexible, incompressible catheter 5700. As shown, one exemplary implementation of such a catheter is composed of multiple layers 5702. Some layers 5702 flow into other layers when the flexible, incompressible catheter 5700 is made by melting or partially melting some of the layers to bond them together. This is called "reflow." However, in the diagrams of FIGS. 57-59, the layers are shown discretely to simplify the drawings.

[0135] Still referring to FIG. 57 , the flexible, non-compressible catheter 5700 can include an outer layer (referred to as a “jacket”) 5704, various intermediate layers 5706, and an inner liner 5708. As described in more detail herein, the intermediate layers 5706 can be selected to provide properties such as stiffness / flexibility and resistance to compression. In addition to the main lumen 5710, additional sub-lumens can be added to implementations of the flexible, non-compressible catheter 5700. One example of this is shown in FIG. 58 , where four sub-lumens 5712 are positioned between the intermediate layers 5706. The number and arrangement of the sub-lumens 5712 are non-limiting examples. A greater or fewer number of sub-lumens can be formed in the illustrative implementation. Additionally, the arrangement of the sub-lumens 5712 can vary depending on the intended use of the catheter 5700. The sub-lumens can be used for fastener drive lines, tethers, pressure monitoring, and other device control and / or monitoring.

[0136] 59 shows a side perspective view of one exemplary implementation. Typically, the catheter 5700 is formed with a round cross-section, although other implementations may be formed with other shapes, such as, but not limited to, oval and teardrop shapes. Shown is a main lumen 5710 with a single sublumen 5712, although any number of sublumens may be included.

[0137] Figure 60 is a cross-sectional view taken along the plane indicated by line 60-60 in Figure 59. The various layers 5702 forming the catheter 5700 are shown in the catheter cross-section illustrated in Figure 60. In the illustrated example, the upper and lower portions of the view are symmetrical, and therefore only the upper portion is labeled with a reference number. However, in some implementations, the upper and lower portions of the cross-section are not symmetrical.

[0138] The right side of Figure 60 shows the proximal end of the implant catheter 5700. The curves through the catheter in Figures 60, 61A, and 61B represent that the catheter is substantially longer than shown in the figures. The right-hand or proximal side of the jacket 5704 may be formed from a nylon material. Some exemplary implementations of the proximal jacket portion 5704 may be formed from a material having a lower durometer than nylon. Examples of materials having a lower durometer than nylon include, but are not limited to, silicone rubber latex, thermoplastic elastomers including, but not limited to, PEBAX, silicone, polyvinyl chloride (PVC), polyethylene (PE), polytetrafluoroethylene (PTFE-Teflon), silicone, polyurethane (PU), and blends of one or more of nylon, thermoplastic elastomers including, but not limited to, PEBAX, silicone, PVC, Dacron, PE, PTFE, polyurethane (PU), and silicone.

[0139] Referring to the left or distal side of FIG. 60 , the distal end of the jacket can optionally have a varying durometer. In some implementations, the entire jacket 5704 can be made from the same material. Having a varying durometer at the distal end of the jacket enhances the ability of the catheter 5700 to bend to the positions illustrated by FIGS. 18-20 . The jacket 5704 can be provided with distal sections having varying durometers in a variety of different ways. In the illustrated example, the outer jacket 504 has distal sections 6014, 6016, 6018 having different durometers. The sections 6014, 6016, 6018 can be formed to have different durometers in a variety of different ways. For example, the sections can be made from different materials, the sections can be reinforced to different degrees, the sections can include cuts or reliefs, etc. In one exemplary implementation, these sections 6014, 6016, 6018 each comprise a thermoplastic elastomer such as PEBAX. For example, the first section 6014 can have a durometer between 45D and 70D, such as about 55D, and can be made from a thermoplastic elastomer such as Pebax; the second section 6016 can have a durometer between 15D and 35D, such as about 25D, and can be made from a thermoplastic elastomer such as Pebax; and the third section 6018 can have a durometer between 45D and 70D, such as about 55D, and can be made from a thermoplastic elastomer such as Pebax. These modifications serve to form sections of the jacket that are more flexible than the remainder of the jacket 6104. The thermoplastic elastomer material and durometer range, such as Pebax, are merely examples; other materials, as well as more or fewer sections, can be used in other implementations.

[0140] 60 , the next inner layer is a braid or mesh layer 6006 that can be used to provide resistance to twisting and allow torque to be applied by the catheter 5700 to manipulate, attach, or otherwise position certain tools and / or implantable devices using the catheter 5700. The braided layer 6006 can be woven from multiple individual metal strands. In some exemplary implementations, instead of weaving, the braided layer 6006 can be formed from one or more laser-cut tubes. The cuts in the tube are also configured to provide resistance to twisting and allow torque to be applied by the catheter to manipulate, attach, or otherwise position certain tools or implantable devices using the catheter 5700, with the advantage that the cut pattern can be varied along the length of the catheter and optimized for the particular application and placement of the catheter.

[0141] 60 , one or more lumens 5712 are disposed inside the braid or mesh layer 6006. In some exemplary implementations, the lumen 5712 is omitted. The one or more lumens can take a variety of different forms. In one exemplary implementation, the one or more lumens are formed by positioning a tube inside the braid or mesh layer 6006. Such a tube can be made from a variety of different materials. In one exemplary implementation, the tube forming the lumen 5712 is made from a material having a melting or flow temperature higher than the melting or flow temperature of the material of the outer jacket 5704. In one exemplary implementation, the one or more lumens 5712 are formed from PTFE. For example, the one or more lumens can be formed from a PTFE tube or jacket having a durometer between 45D and 65D, such as about 55D.

[0142] Still referring to FIG. 60, the next inner layer is the coil 6008. The coil can take a variety of different shapes. The coil 6008 can be made from round, square, rectangular, or other shaped wire, as described in more detail below. In one exemplary implementation, the coil 6008 is formed from round wire having a diameter of 0.002 to 0.020 inches, such as 0.04 to about 0.010 inches, such as 0.060 to 0.070 inches, or about .0065 inches. The coil provides resistance to compression of the catheter 5700 while allowing the catheter to bend. The coil 6008 allows the catheter to be precisely inserted into the steerable catheter 140 (see FIG. 16) (without risk of expansion or contraction along the length of the lumen) and extended or retracted from the steerable catheter.

[0143] 60 , the next inner layer is the wall 6010. The wall 6010 can take a variety of different forms. The wall 6010 can be formed from a nylon material. In some implementations, the wall 6010 can be formed from a material having a lower durometer than nylon. Examples of materials having a lower durometer than nylon include, but are not limited to, silicone rubber latex, thermoplastic elastomers including, but not limited to, PEBAX, silicone, polyvinyl chloride (PVC), polyethylene (PE), polytetrafluoroethylene (PTFE-Teflon®), silicone, polyurethane (PU), and blends of one or more of nylon, thermoplastic elastomers including, but not limited to, PEBAX, silicone, PVC, Dacron, PE, PTFE, polyurethane (PU), and silicone. In one exemplary implementation, the wall 6010 has a thickness in the range of 0.00025 to 0.008 inches, such as 0.0005 to 0.004 inches, such as 0.001 to 0.002 inches.

[0144] Referring to the left or distal side of FIG. 60 , the distal end of the wall 6010 can optionally have a lower durometer compared to the remainder of the wall. Having a lower durometer at the distal end of the wall 6010 enhances the ability of the catheter 5700 to bend to the positions illustrated by FIGS. 18-20 . The wall 6010 can be provided with a distal section having a lower durometer in a variety of different ways. For example, the distal end of the wall 6010 can be made from a different material than the remainder of the wall, can include cuts or reliefs, etc. In one exemplary implementation, the distal end of the catheter can include a thermoplastic elastomer such as PEBAX. This modification can aid in creating a section of the wall 6010 that is more flexible than the remainder of the wall 6010. Thermoplastic elastomer materials and durometer ranges, such as Pebax, are non-limiting examples, and other materials can be used in other implementations.

[0145] 60 , the innermost layer of the catheter 5700 is the wall 5708 of the main lumen 5710. The main lumen 5710 can take a variety of different forms. In one exemplary implementation, the main lumen 5710 is formed by disposing or forming the other layers 6010, 6008, 6006, 5704 around a tubular or annular wall 5708. Such tubing can be made from a variety of different materials. In one exemplary implementation, the tubing 5708 is made from a material that has a higher melting or flow temperature than the melting or flow temperature of the material of the wall 6010. In one exemplary implementation, the tubing 5708 is made from PTFE.

[0146] In one exemplary implementation, the layers of catheter 5700 are assembled as illustrated by Fig. 60 and heated to cause one or more of layers 5702 to melt and flow. For example, layers 5704 and 6010 and portions 6014, 6016, 6018 melt and flow through coil 6008 and braid 6006, blend together where they meet, and solidify to form the completed composite catheter 5700. As noted above, this process is sometimes referred to as "reflow."

[0147] The catheter structure illustrated by FIG. 60 provides the ability to transmit torque without resistance to twisting or distortion as a result of the braid 6006 and expansion and contraction along its length as a result of the coil 6008. However, one effect of the reflow process is to reduce the flexibility of the catheter as the reflowed plastic material may fill the spaces between the individual windings of the coil 6008 and bond the individual windings together. As noted above, the distal end of the catheter 5700 may be caused to undergo relatively sharp turns or bends when delivering the implant 100 (see FIGS. 18-20). As the reflowed plastic material fills the spaces between the individual windings of the coil 6008 and / or bonds the individual windings together, the ability of the distal end of the catheter 5700 to undergo relatively sharp turns or bends when delivering the implant 100 may be impaired, as shown in FIGS. 18-20.

[0148] 61A and 61B show an exemplary implementation of a composite catheter 6100 in which the plastic material is prevented from reflowing into the spaces between the individual windings of a portion of the coil 6008. As a result, this portion of the catheter 6100 has more flexibility than an otherwise identical catheter 5700 if the plastic had reflowed into the spaces between the individual windings of the entire coil 6008. This additional flexibility can be used to enhance the ability of the distal end of the catheter 5700 to undergo relatively sharp turns or bends when delivering the implant 100, as shown in FIGS.

[0149] The plastic material can be prevented from reflowing into the spaces between the individual windings in a variety of different ways. For example, one or more portions of the coil 6008 can be shielded and / or one or more portions of the reflowing material can be omitted around one or more portions of the coil. Figures 61A and 61B show two examples of implant catheters in which the plastic material is prevented from reflowing into the spaces between the individual windings of a portion of the coil 6008.

[0150] In the example illustrated by Figure 61A, the catheter 6100 has substantially the same structure as the catheter 5700 of Figure 60, except that the coil portion 6150 is shielded on one side from the reflowing material and the reflowing material is omitted on the other side of the coil portion 6150. In the example shown by Figure 61A, the outside of the coil portion 6150 is shielded from the reflowing material and the reflowing material is omitted on the inside of the coil portion 6150. However, in some implementations, the inside of the coil portion 6150 is shielded from the reflowing material and the reflowing material is omitted on the outside of the coil portion 6150.

[0151] The coil portion 6150 may be shielded from the reflowing material in a variety of different ways. For example, the outer surface of the coil portion 6150 may be wrapped, sleeved, or coated with a barrier material 6022, the inner surface of the coil portion 6150 may be sleeved or coated with a barrier material 6022, the wall 6010 may be wrapped, sleeved, or coated with a barrier material, and / or the liner 6112 may be wrapped, sleeved, or coated with a barrier material. Any manner that prevents the plastic material from reflowing into the spaces between the windings of the coil 6008 may be implemented.

[0152] In the example shown by FIG. 61A, a barrier 6022, such as a liner, tube, wrap, or coating, is positioned on the outer surface of the coil portion 6150, and a gap 6020 is formed between the distal and proximal portions of the wall 6010 adjacent the inner surface of the coil portion 6150.

[0153] The barrier 6022 can take a variety of different forms. In one exemplary implementation, the barrier 6022 is a tube. Such a tube can be made from a variety of different materials. In one exemplary implementation, the barrier is made from a material that has a melting or flow temperature higher than the melting or flow temperature of the material of the jacket 5704. In one exemplary implementation, the barrier is formed from PTFE.

[0154] In one exemplary implementation, an adhesive is optionally used to hold this barrier 6022 in place on the coil portion 6150. In one exemplary implementation, the adhesive is omitted and the reflowed material holds the barrier in place. The ends of the barrier 6022 or the entire barrier are glued to the coil 6008 with an adhesive such as polyethylene terephthalate (PET).

[0155] The gap 6020 can be formed in a variety of different ways. For example, two spaced-apart sleeves can be provided or formed around the liner 5708 to form the gap, or a continuous wall 6010 can be provided and then a portion removed to form the gap. As noted above, the proximal and distal portions of the wall 6010 can be made from different materials. In one exemplary implementation, the material of the portion of the wall proximal to the gap 6020 is different from the material of the portion of the wall distal to the gap. In one exemplary implementation, the material of the portion of the wall proximal to the gap 6020 is nylon, and the material of the portion of the wall distal to the gap is a thermoplastic elastomer, such as PBAX.

[0156] The length of the non-reflow coil portion 6150 can be selected based on the degree of curvature, the diameter of the catheter, and the distal stiffness required for the particular application in which the catheter will be used. In some implementations, the length of the coil portion 6150 is between 2 and 10 inches, such as between 4 and 8 inches, such as between 5 and 7 inches, or about 6 inches. Other portion 6020 lengths can be used depending on the diameter of the catheter and the degree of flexibility required by the intended application.

[0157] In the example illustrated by Figure 61B, the catheter 6100 has substantially the same structure as the catheter 5700 of Figure 60, except that the coil portion 6150 is shielded both inside and outside from the reflowing material. However, in some implementations, the reflowing material may be omitted both inside and outside of the coil portion 6150 instead of shielding the coil portion 6150.

[0158] The coil portion 6150 may be shielded from the reflowing material in a variety of different ways. For example, the outer surface of the coil portion 6150 may be wrapped, sleeved, or coated with a barrier material 6022, the inner surface of the coil portion 6150 may be sleeved or coated with a barrier material 6022, the wall 6010 may be wrapped, sleeved, or coated with a barrier material, and / or the liner 6112 may be wrapped, sleeved, or coated with a barrier material. Any manner that prevents the plastic material from reflowing into the spaces between the windings of the coil 6008 may be implemented.

[0159] In the example illustrated by FIG. 61B, a barrier 6022, such as a liner, tube, wrap, or coating, is positioned on the outer surface of the coil portion 6150, and a barrier gap 6109, such as a liner, tube, wrap, or coating, is positioned on the inner surface of the coil portion 6150.

[0160] The barriers 6022, 6109 can take a variety of different forms. In one exemplary implementation, the barriers 6022, 6109 are tubes. Such tubes can be made from a variety of different materials. In one exemplary implementation, the barriers are made from a material that has a higher melting or flow temperature than the melting or flow temperature of the material of the jacket 5704 and the wall 6110. In one exemplary implementation, the barriers can be formed from PTFE.

[0161] In one exemplary implementation, adhesive is optionally used to hold the barrier 6022, 6109 in place on the coil portion 6150. In one implementation, the adhesive is omitted and the reflowed material holds the barrier in place. The ends of the barrier 6022, 6109 or the entire barrier can be glued to the coil 6008 with an adhesive such as polyethylene terephthalate (PET).

[0162] As previously mentioned herein, the coil portion of the catheter provides resistance to expansion or compression of the length of the catheter. This is important for proper positioning and manipulation of the implant 100 or other operations performed using the catheter. Figure 62A depicts a cross-section of a known coil design. As shown, the coil 6200 is formed from a wire that is substantially round in cross-section.

[0163] Referring to FIG. 62B , in one exemplary implementation, the number of turns of wire for a given length of coil, e.g., the number of turns per inch, is reduced, thereby increasing the distance between each coil (this is sometimes referred to as the pitch). Increasing the pitch increases the gap between each pair of adjacent coils. That is, the wire 6206 is wound so that more space 6208 exists between the turns of the wire 6206. This design allows for a higher level of movement between the individual coils. To maintain a level of resistance to contraction along the length of the catheter, a material 6210 such as nylon (but could be a variety of materials, including any of the materials previously described with respect to the catheter layers herein) is placed adjacent to the coil 6204 and softened by heat or other means so that it flows into the spaces between the individual wires 6206. The result is a coil that is more flexible than known designs 6200, yet still resists compression.

[0164] FIG. 62B shows the material 6210 after it has flowed between two turns of the coil. The catheter can be customized to flow the material 6210 between every turn of the coil, some turns of the coil, or between pairs of turns. This can be customized to achieve different properties of the final implant catheter. The material 6210 between each turn will have the strongest resistance to compression, while material between various turns can be omitted to provide more flexibility and / or some compression. In one implementation, the material 6210 flows between every other pair of turns. In one implementation, the material 6210 flows between every turn of the coil. In one implementation, the material 6210 flows between 70-95% of the turns of the coil.

[0165] A rectangular cross-section can be used to further increase the catheter's resistance to compression and stretching. Such a coil 6300 is illustrated in FIGS. 63A and 63B. A coil having a rectangular shape of wire 6302 can provide a flat surface at each wire 6302 that aligns with the next winding of the coil to prevent compression of the coil. However, as illustrated in FIG. 63B, when bending of coil 6300 is induced, the coil wires (e.g., 6304 and 6305) can shift position and slip past each other, as illustrated by 6306. The result is a catheter with a reduced ability to resist compressive forces when the catheter is bent. Additionally, the slipping coil can cause distortion of the inner and outer surfaces of the catheter.

[0166] 64A and 64B show an improved example of a rectangular cross-section coil 6400. In this example, the wire 6402 has a height H that is greater than its width W. This configuration reduces the chance of the wires slipping. For example, the coils will not slip past each other, as shown in the coil of FIG. 64B.

[0167] In one exemplary implementation, the coil is formed in a "nose" and "socket" arrangement. Such a coil 6500 is illustrated in FIGS. 65A and 65B. As seen in FIG. 65A, the wire used to form the coil has a convex surface 6502 and a concave surface 6504. When the wire is formed into the coil 6500, the wire is wound in an orientation such that the convex surface 6502 is oriented to face the concave surface 6504. As a result, the concave surface 6504 acts to hold the convex surface 6502 aligned with the concave surface 6504. As illustrated in FIG. 65B, when the coil is bent or curved 6506, the convex surface 6502 intrudes into the space formed by the concave surface 6504 of the adjacent wire. As a result, the individual wires are prevented from slipping out of place, as illustrated for the wire coil shown in FIG. 63B.

[0168] Although various inventive aspects, concepts, and features of the present disclosure have been described and illustrated herein as embodied in a combination of exemplary embodiments, these various aspects, concepts, and features can be used individually in many alternative embodiments or in various combinations and subcombinations thereof. Unless specifically excluded herein, all such combinations and subcombinations are intended to be within the scope of the present application. Furthermore, although various alternatives for various aspects, concepts, and features of the present disclosure (such as alternative materials, structures, forms, methods, devices, and components, and alternatives in terms of form, fit, and function) have been described herein, such descriptions are not intended to be a complete or exhaustive list of all available alternative embodiments, whether currently known or later developed. Those skilled in the art will be able to readily incorporate one or more of the aspects, concepts, and features of the present invention into additional embodiments and applications within the scope of the present application, even if such embodiments are not explicitly disclosed herein.

[0169] Additionally, even if some features, concepts, or aspects of the present disclosure are described herein as preferred configurations or methods, such description does not imply that such features are required or necessary, unless specifically stated. Furthermore, while example or representative values ​​and ranges may be included to aid in understanding the present application, such values ​​and ranges should not be construed in a limiting sense, and should only be the limits of values ​​or ranges where expressly stated.

[0170] Furthermore, while various aspects, features, and concepts may be expressly identified as being inventive or forming part of the disclosure, such identification is not intended to be exhaustive; rather, there may be aspects, concepts, and features of the invention that are fully described herein without being expressly identified as being part of or of such specific disclosure, which disclosure is instead set forth in the appended claims. Descriptions of exemplary methods and processes are not limited to the inclusion of all steps as required in all cases, nor should they be construed as requiring or requiring the order in which steps are presented, unless expressly stated. Furthermore, the techniques, methods, operations, steps, etc. described or suggested herein can be performed in live animals or in non-in vivo simulations, such as cadavers, cadaver hearts, simulation devices (e.g., simulating body parts, tissues, etc.). The terms used in the claims have their full and ordinary meaning and are not limited in any way by the description of the embodiments herein. [Explanation of symbols]

[0171] 10 Devices, implants 20, 22 leaflets 30 Anterior valve leaflet 32 Septal leaflet 34 Posterior leaflet 100 devices or implants 102 Delivery sheath or means for delivery 104 Joint or joint forming part 106 Anchor part 108 Anchor 110 Joint-forming elements or means for joining 111, 113 Means for driving or driving element 112 Driving means or driving elements 114 Cap 115 Color, Cap 116 Drive Line 117 Couplers, Caps 120 outer paddle 122 Inner Paddle 124, 126, 128 connection part 130 Fasteners 132 Base or fixed arm 134 Movable Arm 136 Optional barbs, friction enhancing elements, or other means of fastening 138 Joint 140 Steerable Catheter 142 Delivery Sheath / Catheter 200 Implantable Devices or Implants 201 Side 202 Delivery System 203 Central plane 204 Joint or joint forming part 205 Proximal or Attachment 206 Anchor part 207 Distal 208 Anchor 210 Joint forming elements 211 First or Proximal Collar 212 Driving Elements 213 Capture mechanism 214 Cap 220 outer paddle 221 Connecting part 222 Inner Paddle 223 Connecting part 224 Paddle extension member or paddle frame 230 Fasteners 231 Hole or slot 232 Base or Fixed Arm 234 Movable Arm 235 holes 236 Barb / Friction-enhancing element 238 Joint 240 Cover 241 Implant Catheter 242 Delivery Catheter / Sheath 300 Implantable prosthetic devices or implants 301 Material Strips 304 Joint forming part 305 Proximal or Attachment 306 Anchor part 307 Distal 308 Anchor 310 Joint forming elements 311 First or Proximal Collar 314 Cap 320 outer paddle 321 Connection section 322 Inner Paddle 323 Connecting part 324 Paddle extension member or paddle frame 325 Connecting part 330 Fasteners 332 Base or Fixed Arm 334 Movable Arm 336 Barb / Friction-enhancing element 338 Joint 5700 Catheter 5700 Flexible, non-compressible catheter 5702 layers 5704 outer layer (called "jacket") 5706 Middle class 5708 Inner liner 5710 main lumens 5712 Sublumen 6006 Braided or mesh layer 6008 Coil 6010 Wall 6014, 6016, 6018 Distal Section 6020 Gap 6022 Barrier materials 6100 Composite Catheter 6104 Jacket 6112 Liner 6150 Coil part 6200 coil 6204 Coil 6206 Wire 6208 Space 6210 Material 6300 coil 6302 Wire 6400 Rectangular cross section coil 6402 Wire 6500 coils 6502 Convex 6504 Concave

Claims

1. The outer jacket and one or more layers positioned inside the outer jacket; a reinforcing layer positioned inside the outer jacket; a first leak shield including a barrier material wrapped, sleeved, or coated on an outer surface of the reinforcing layer, the first leak shield being positioned between the reinforcing layer and the outer jacket; and Equipped with the outer jacket and at least one of the one or more layers are reflowed to bond the outer jacket, the reinforcing layer, and the one or more layers to one another; a portion of the reinforcing layer that is free of all of the material of the outer jacket and the one or more layers that is reflowed; The first leak shield prevents reflowed material of the outer jacket from contacting a portion of the reinforcement layer.

2. The catheter of claim 1 further comprising a plurality of sublumens.

3. The catheter of claim 1 or 2, wherein a first portion of the outer jacket is formed from a material having an enhanced level of flexibility compared to the remainder of the outer jacket.

4. The catheter of claim 1 or 2, wherein the reinforcing layer is formed from a self-aligning wire.

5. Lumens and a second leak shield disposed adjacent to the reinforcement layer and interposed between the reinforcement layer and the lumen; The catheter of claim 1 or 2, further comprising:

6. The catheter of claim 5 , wherein the first leak shield and the second leak shield are formed from polytetrafluoroethylene.

7. The catheter of claim 5 , wherein a first portion of the outer jacket is formed from a material having an enhanced level of flexibility compared to a remainder of the outer jacket.

8. The catheter of claim 7 , wherein the reinforcing layer is made from self-aligning wire.

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