Valved catheter with expandable frame

Abstract

Various aspects of the present disclosure are directed to devices, systems, and methods including valved catheters.A valved catheter may include a frame element disposed within the catheter and one or more expansion elements configured to expand to radially expand the frame.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of Provisional Patent Application No. 62 / 843,911 filed May 6, 2019, which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] The present disclosure relates generally to prosthetic valves, and more particularly to devices, systems, and methods including a catheter having an expandable frame therein. Background Art

[0004] Bioprosthetic heart valves have been developed that attempt to mimic the function and performance of natural valves. Flexible leaflets can be mechanically coupled to a relatively rigid frame that supports the leaflets and provides dimensional stability when implanted. Although bioprosthetic heart valves can provide excellent hemodynamic and biomechanical properties for a short period of time, they are prone to calcification and cusp tearing, or other failure modes, requiring reoperation and replacement.

[0005] In some cases, the leaflets can be arranged within a catheter, such as within a pulmonary valve catheter. However, various situations arise in which the necessary diameter profile of a valved catheter changes from one point in time to another. For example, in pediatric applications, a valve portion of a valved catheter having a first smaller inner diameter (i.e., inner flow diameter) may be appropriate, but as the patient grows, a larger inner diameter of the prosthetic valve is required. Removing the existing valve and / or implanting another valve with a larger flow diameter may cause various complications and associated risks. Summary of the invention

[0006] According to one example ("Example 1"), a valved catheter includes a catheter having an inner surface and an outer surface; and a frame element, which is arranged in the catheter and has commissures arranged around the frame element, the frame element having a first diameter in a first structure and being configured to support a valve structure having leaflets, the leaflets being configured to open to allow flow and close to block the catheter cavity and prevent flow in response to a fluid pressure difference, and to expand to a larger second diameter in a second structure in response to a force applied to an inner portion of the frame element; and one or more expansion elements, which are arranged between or adjacent to the commissures and are configured to stretch to radially expand the frame element in the transition between the first structure and the second structure.

[0007] According to another example ("Example 2"), further to the valved catheter of Example 1, the frame element is configured to accommodate a second valve structure therein in the second configuration.

[0008] According to another example ("Example 3"), further to the valved catheter of any one of Examples 1-2, the frame element includes a first circular edge and a second circular edge connected by a commissure, and one or more expansion elements form a part of at least one of the first circular edge and the second circular edge.

[0009] According to another example ("Example 4"), further to the valved catheter of Example 3, one or more expansion elements are arranged together with one of the first circular edge and the second circular edge and extend toward the other of the first circular edge and the second circular edge.

[0010] According to another example ("Example 5"), further to the valved catheter of Example 4, the one or more expansion elements include a first linear portion, a second linear portion, and a curved portion.

[0011] According to another example ("Example 6"), further to the valved catheter of Example 5, the first linear portion and the second linear portion extend substantially parallel to the longitudinal axis of the frame element in the first structure, and are configured to be angled relative to the longitudinal axis of the frame element in the second structure.

[0012] According to another example ("Example 7"), further to the valved catheter of any of Examples 1-6, one or more expansion elements are disposed between the commissure posts.

[0013] According to another example ("Example 8"), further to the valved catheter of any of Examples 1-7, one or more dilation elements are arranged adjacent to the commissure posts.

[0014] According to another example ("Example 9"), further to the valved catheter of any of Examples 1-8, one or more expansion elements are disposed between portions of the commissure posts.

[0015] According to another example ("Example 10"), further to the valved catheter of any of Examples 1-9, the frame element includes a plurality of commissure posts and the one or more expansion elements include a plurality of expansion elements arranged between portions of each commissure post.

[0016] According to another example ("Example 11"), further to the valved catheter of Example 10, the valved catheter also includes a plurality of additional expansion elements arranged between the commissure posts.

[0017] According to another example ("Example 12"), further to the valved catheter of any of Examples 1-11, one or more expansion elements are configured to increase a diameter of the frame element.

[0018] According to one example ("Example 13"), an expandable prosthetic device includes a valve structure; and a frame element, the frame element being configured to support the valve structure in a first structure and including one or more expansion elements, the expansion elements being configured to radially expand the frame element to a second structure, the second structure having a diameter greater than the diameter of the frame element in the first structure to accommodate a second valve structure in the second structure and maintain a continuous outer periphery.

[0019] According to another example ("Example 14"), further to the expandable prosthetic device of Example 13, the frame element includes a first circular edge and a second circular edge, and the one or more expansion elements form part of at least one of the first circular edge and the second circular edge.

[0020] According to another example ("Example 15"), further to the expandable prosthetic device of Example 14, one or more expansion elements include a first linear portion and a second linear portion, and the first linear portion and the second linear portion extend substantially parallel to the longitudinal axis of the frame element in the first structure, and are configured to be angled relative to the longitudinal axis of the frame element in the second structure.

[0021] According to another example ("Example 16"), further to the expandable prosthetic device of Example 13, the device also includes a catheter, and the frame element is disposed within the catheter.

[0022] According to one example ("Example 17"), a method for repairing or replacing a patient's aortic valve or pulmonary valve includes placing a valved catheter at a target location in the patient's body, wherein the valved catheter includes a valve structure, a frame element configured to support the valve structure includes leaflets, the leaflets are configured to open in a first structure in response to a fluid pressure difference to allow flow and close to block the catheter cavity and prevent flow, and include one or more expansion elements, the expansion elements are configured to radially expand the frame element; apply force inside the frame element to radially expand the frame element to a second structure having a diameter larger than the first structure while maintaining a continuous outer periphery of the frame element; and place a second valve structure within the expanded frame element.

[0023] According to another example ("Example 18"), further to the method of Example 17, placing the valved catheter includes unfolding (deploying) the valved catheter to replace the patient's pulmonary valve.

[0024] According to another example ("Example 19"), further to the method of Example 17, the frame element includes a first circular edge and a second circular edge, and one or more expansion elements form a part of at least one of the first circular edge and the second circular edge, and the one or more expansion elements include a first linear portion and a second linear portion, and the first linear portion and the second linear portion extend substantially parallel to the longitudinal axis of the frame element in the first structure, and are configured to be angled (inclined) relative to the longitudinal axis of the frame element in the second structure.

[0025] According to another example ("Example 20"), further to the method of Example 19, the first linear portion and the second linear portion extend substantially parallel to the longitudinal axis of the frame element in the first structure, and are configured to be angled relative to the longitudinal axis of the frame element in the second structure.

[0026] According to one example ("Example 21"), a valved catheter for accommodating a first valve structure and allowing expansion to accommodate a second valve structure includes a catheter having an inner surface and an outer surface; and a frame element arranged in the catheter, the frame element including a first diameter in a first structure and configured to support a first valve structure having leaflets, the leaflets being configured to open in response to a fluid pressure difference to allow flow, and to close to block the catheter cavity and prevent flow, the frame element having: a first circular edge, a second circular edge, commissures arranged around the frame element and connecting the first circular edge and the second circular edge, an upper expansion element arranged along the first circular edge between or adjacent to the commissures, and a lower expansion element arranged along the second circular edge between or adjacent to the commissures, at least one of the upper expansion element and the lower expansion element being configured to expand (expand) in response to a force applied to an inner portion of the frame element to radially expand the frame element in the transition between the larger second diameters in the first structure and the second structure, thereby supporting the second valve structure having leaflets.

[0027] According to another example ("Example 22"), in the valved catheter as described in Example 21, the frame element is configured to deform to maintain a gap between leaflets of the second valve structure.

[0028] According to another example ("Example 23"), in the valved catheter as described in Example 21, the upper expansion element and the lower expansion element are configured to maintain the frame element at a diameter desired by the internal radial force in the second configuration.

[0029] According to another example ("Example 24"), in the valved catheter as described in Example 21, the upper expansion element and the lower expansion element are configured to expand in an inclined manner so that the frame element expands linearly.

[0030] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by the present disclosure. Although a number of examples are disclosed, other examples will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples of the present invention. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The accompanying drawings are used to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments and together with the description serve to explain the principles of the present disclosure.

[0032] Figure 1A is an illustration of an exemplary valved catheter according to an embodiment;

[0033] Figure 1B It shows that Figure 1A An internal downstream view of the valve structure shown in a closed configuration;

[0034] Figure 2 is a cross-sectional view of a catheter, a frame member, and a valve structure according to an embodiment;

[0035] Figure 3A is an example frame element in a first configuration according to an embodiment;

[0036] Figure 3B According to an embodiment, the second configuration Figure 3A The frame elements shown in ;

[0037] Figure 4A is another example frame element in a first configuration according to an embodiment; and

[0038] Figure 4B According to an embodiment, the second configuration Figure 4A The frame elements shown in . DETAILED DESCRIPTION

[0039] Definitions and terminology

[0040] This disclosure is not intended to be read in a limiting manner. For example, the terms used in this application should be read broadly in the context of the meanings that those skilled in the art would attribute to such terms.

[0041] With respect to imprecise terms, the terms "about" and "approximately" are used interchangeably to refer to measurements that include the measured value and also any measurements that are reasonably (fairly) close to the measured value. As understood and easily determined by a person of ordinary skill in the relevant art, a measurement that is reasonably close to the measured value deviates from the measured value by a relatively small amount. Such deviations may be attributed to, for example, measurement errors, differences in calibration of the measured values ​​and / or manufacturing equipment, human errors in reading and / or setting the measured values, fine-tuning to optimize performance and / or structural parameters in view of differences in the measured values ​​associated with other components, specific implementation scenarios, imprecise adjustments and / or manipulations of objects by humans or machines, and / or the like. If it is determined that a person of ordinary skill in the relevant art would not easily determine the value of such a reasonably small difference, the terms "about" and "approximately" may be understood as plus or minus 10% of the value.

[0042] Description of various embodiments

[0043] Those skilled in the art will readily appreciate that various aspects of the present invention may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the drawings referenced herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting.

[0044] Although the embodiments herein may be described in conjunction with various principles and concepts, the described embodiments should not be limited by theory. For example, embodiments are described herein in conjunction with prosthetic valved catheters. However, embodiments within the scope of the present disclosure may be applied to any valved catheter, valve structure or mechanism having similar structure and / or function. In addition, embodiments within the scope of the present disclosure may be applied to non-cardiac applications.

[0045] Aspects of the present disclosure relate to various devices, systems and methods for a catheter having a valve structure operable as a prosthetic valve, which can be used, for example but not limited to, to replace a portion of a pulmonary valve and a corresponding pulmonary artery. The valve structure may include one or more leaflets operable as a one-way valve, which define a catheter lumen with the catheter. The (one or more) leaflets open in response to a fluid pressure difference to allow flow, and close to block the catheter lumen and prevent flow. In addition, the catheter may include a frame element supporting the valve structure. In some cases, a patient with a catheter may grow beyond the catheter, causing the valve structure to no longer function or not function as desired. As discussed in further detail below, the frame element may be configured to expand to allow a second valve structure to be installed in the frame element / valve structure of the catheter. The second valve structure may be a prosthetic valve that can be deployed (in the catheter) to replace a previously deployed valve structure.

[0046] Embodiments herein include various devices, systems and methods for a catheter having a valve structure operable as a prosthetic valve that can be used, for example but not limited to, to replace an aortic valve and a portion of the aorta, such as a portion of the ascending aorta. The catheter is operable to be surgically coupled to the left atrium at the proximal end of the catheter and to a portion of the ascending aorta as the distal end of the catheter. In other embodiments, the catheter is also operable to surgically attach one or more coronary arteries thereto to establish blood flow thereto.

[0047] Figure 1A is an illustration of an exemplary valved catheter 100 according to an embodiment. Valved catheter 100 includes a catheter 102 having a valve structure 104 disposed within catheter 102. Catheter 102 may include an upstream end and a downstream end such that valve structure 104 allows flow in one direction.

[0048] In a non-limiting example, the valved catheter 100 can be used to replace at least a portion of the aortic valve and the ascending aorta. In a non-limiting example, the valved catheter 100 can be indicated for correction or reconstruction of the aortic root and aortic valve, i.e., aortic root replacement, in pediatric patients. The valved catheter 100 can also be indicated for replacement of a previously implanted valved catheter or homograft that has become dysfunctional or inadequate.

[0049] In a non-limiting example, the valved catheter 100 can be used as a shunt to connect the right ventricle to the pulmonary artery after a Norwood procedure, as is often performed to treat hypoplastic left heart syndrome. In a non-limiting example, the valved catheter 100 can be indicated for correction or reconstruction of the right ventricular outflow tract (RVOT) in a pediatric patient. Such reconstruction can be used for congenital heart disease, such as tetralogy of Fallot, truncus arterious, right-hand displacement of the great arteries, pulmonary atresia with intact ventricular septum, or aortic valvular disease. The valved catheter 100 can also be indicated for replacement of a previously implanted valved catheter or homograft that has become dysfunctional or inadequate. In addition, the valved catheter 100 can have a wide range of cardiac treatment applications, including other parts of the heart. Generally, in this disclosure, the term "distal" is used to refer to the outflow end (distal end) or outflow direction of the valved catheter 100, and the term "proximal" is used to refer to the inflow end of the valved catheter 100, or the direction opposite to the direction of main flow through the valved catheter 100.

[0050] like Figure 1A shown and in Figure 2As described in more detail in , the valved catheter 100 may include a frame element 300. The frame element 300 may be configured to support the valve structure 104 and the leaflets 106. The valve structure 104 may be formed of silicone or another flexible polymer applied to an outer surface or portion (e.g., outer diameter) of the frame element 300. In some cases, the catheter 100 is formed of a graft material and the frame element 300 is the only support structure arranged with the catheter 100. The catheter 100 may, for example, be free of a stent or stent-like feature other than the frame element 300.

[0051] Figure 1B It shows that Figure 1A 1, a downstream view of the interior of the valve structure 104 in a closed configuration. The valve structure 104 includes leaflets 106 extending into the interior of the catheter 102. Figure 1B Although three leaflets 106 are shown in the figure, the valve structure 104 may include one, two, three, four, five, six, seven, eight or more leaflets 106. Figure 1B As shown, the leaflets 106 are closed toward the center 108 of the catheter 102 in the closed configuration. Figure 1B As shown, there are gaps 112 between each leaflet 106. The gaps 112 allow backflow through the catheter 102. Backflow reduces the chance of blood stagnating (stagnation) behind the leaflets 106, which could cause thrombosis. The gaps 112 are sized so that leakage caused by backflow is minimized and does not otherwise increase the pressure (stress) on the patient's heart that pumps blood through the catheter 102. In the open configuration, blood can flow through the valve structure 104 while the leaflets 106 are forced toward the inner surface 110 of the catheter 102. The leaflets 106 can be as Figure 2 104 and 105. The valve leaflets 106 are configured to open to allow flow and close to block the catheter lumen to prevent flow in response to a fluid pressure differential.

[0052] Figure 2 is a cross-sectional view of a catheter 102, a frame member 300, and a valve structure 104 according to an embodiment. The valve structure 104, which may include the frame member 300, is arranged within the catheter 102 such that the leaflets 106 extend into the catheter 102 and toward the center 108 of the catheter 102. The valve structure 104 may be coupled or adhered to the frame member 300 and / or the catheter 102.

[0053] In some cases, the catheter 102 may include one or more radiopaque markers 210 to assist in post-operative visualization of the position of the frame member 300 within the catheter 102 under fluoroscopic visualization. The one or more radiopaque markers 210 may be disposed adjacent to the frame member 300. In other cases, the catheter 102 does not include any radiopaque markers 210 because the frame member 300 may be radiopaque.

[0054] As discussed in further detail below, the frame member 300 is configured to be Figure 2 The valve structure 104 and the leaflets 106 are supported in the first configuration shown. The frame member 300 can include one or more expansion elements 204 configured to expand to radially expand the frame member 300 to a second configuration having a diameter greater than the diameter of the frame member 300 in the first configuration. The one or more expansion elements 204 are configured to expand the diameter of the frame member 300 so that in the second configuration, a second valve structure can be disposed within the frame member 300.

[0055] Figure 3A 1-2 , to form a valved catheter. In other cases, the frame element 300 can be deployed within a patient's body without being deployed within a catheter. As shown, the frame element 300 can define an arch or U-shape. The frame element 300 can also include one or more commissure posts 302, 304, 306. The number of commissure posts 302, 304, 306 (or commissure regions or supports) can be equal to the number of leaflets of the valve structure 104 that the frame element 300 is configured to support. As shown in FIG. Figure 3A As shown, frame member 300 includes three commissure posts 302, 304, 306. Commissure posts 302, 304, 306 may provide locations for attaching leaflets.

[0056] In some cases, the frame member 300 is configured to expand to Figure 3A In this first configuration, frame member 300 is configured to support valve structure 104 at a first deployed diameter. Valve structure 104 and leaflets 106 (shown in FIGS. 1-2 ) can open and close when deployed at a target location in a patient, such as replacing a portion of a pulmonary valve and a corresponding pulmonary artery.

[0057] In some cases, the valve structure 104 and the leaflets 106 (shown in FIGS. 1-2 ) may no longer function as desired due to growth of the patient, calcification of the leaflets 106, or other issues. Therefore, the frame element 300 is configured to be in a second configuration ( Figure 3B The force may be a result of balloon expansion of the frame member 300 or a delivery system carrying the replacement valve structure or the second valve structure 104. The replacement valve structure or the second valve structure 104 may be deployed within the expanded frame member 300.

[0058] To facilitate expansion of the frame element 300 (and the catheter 102 in which the frame element 300 may be implanted), the frame element 300 may include one or more expansion elements 310, 312, 314, 316. The expansion elements 310, 312, 314, 316 may be disposed between one or more commissure posts 302, 304, 306 and configured to expand in the transition between the first configuration and the second configuration to radially expand the frame element 300. The frame element 300 may be configured to accommodate a second valve structure therein in the second configuration. The frame element 300 may expand to allow the second valve structure to be implanted and function without interference from the frame element 300.

[0059] In some cases, the frame member 300 includes a first circular edge 318 and a second circular edge 320 connected by the commissure posts 302, 304, 306. One or more expansion elements 310, 312, 314, 316 can form part of one or both of the first circular edge 318 and the second circular edge 320. For ease of description, in Figure 3A -B. As shown, the expansion elements 310, 312, 314, 316 form a portion of each of the first circular edge 318 and the second circular edge 320. In other cases, the expansion elements 310, 312, 314, 316 may form only a portion of the first circular edge 318 or only a portion of the second circular edge 320. In some cases, the expansion elements 310, 312, 314, 316 that form a portion of the second circular edge 320 may be disposed within a portion of the commissure posts 302, 304, 306.

[0060] For example, the expansion element 314 is disposed within a portion of the commissure post 304. The frame element 300 may include: one expansion element 310, 312, 314, 316 having one of the rounded edges 318, 320; one expansion element 310, 312, 314, 316 having each of the rounded edges 318, 320; two expansion elements 310, 312, 314, 316 having one of the rounded edges 318, 320; two expansion elements 310, 312, 314, 316 having each of the rounded edges 318, 320 , 314, 316; three dilation elements 310, 312, 314, 316 having one of the rounded edges 318, 320; three dilation elements 310, 312, 314, 316 having each of the rounded edges 318, 320; and combinations of the foregoing (e.g., one having one rounded edge 318 and 320 and two having the other rounded edge 318, 320); and additional dilation elements 310, 312, 314, 316. Thus, the frame member 300 can include a plurality of dilation elements 310, 312, 314, 316 that can be disposed between or within the commissure posts 302, 304, 306.

[0061] In some cases, one or more expansion elements 310, 312, 314, 316 are arranged with one of the first circular edge 318 and the second circular edge 320 and extend toward the other of the first circular edge 318 and the second circular edge 320. In addition, the expansion elements 310, 312, 314, 316 may include a first linear portion 322 and a second linear portion 324, as highlighted on the expansion element 310 for ease of illustration. In some cases, the first linear portion 322 and the second linear portion 324 may be connected or coupled together by another linear portion, a serrated portion, a wavy portion, a curved portion, or a combination thereof.

[0062] like Figure 3A As shown, the first linear portion 322 and the second linear portion 324 are connected by a curved portion 326. The curved portion 326 can facilitate the expansion and separation of the first linear (linear) portion 322 and the second linear (linear) portion 324. In addition, the curved portion 326 can absorb and distribute stress on the frame member 300 when expanding and expand to a larger diameter. In some cases, the first linear portion 322 and the second linear portion 324 extend substantially parallel to the longitudinal axis of the frame member 300 in the first configuration, such as Figure 3A , and is configured to be angled (inclined) relative to the longitudinal axis of the frame element 300 in the second configuration, as shown Figure 3B As shown. Figure 3BAs shown, the frame member 300 maintains an uninterrupted or continuous outer perimeter in the second configuration. The expansion members 310, 312, 314, 316 are configured to expand the frame member 300 without rupturing or otherwise disrupting the physical integrity of the frame member 300.

[0063] As described above, the expansion elements 310, 312, 314, 316 are configured to facilitate the expansion of the frame element 300. Figure 3A The first configuration shown and Figure 3B The expansion between the second configuration is shown to increase the diameter of the frame member 300. Figure 3B Shown in the second configuration Figure 3A 300 is shown. As shown in the second configuration, the first linear portion 322 and the second linear portion 324 are transitionally separated and angled to allow the frame member 300 to have an expanded diameter. In addition, the expansion elements 310, 312, 314, 316 maintain the integrity of the frame member 300 in the second configuration and when transitioning to the second configuration. In some cases, the curved portion 326 can release the force so that the expansion elements 310, 312, 314, 316 do not break.

[0064] In some cases, a frame member 300 having expansion elements 310, 312, 314, 316 on each of the first circular edge 318 and the second circular edge 320 can allow for expansion of each of the first circular edge 318 and the second circular edge 320. Furthermore, a first circular edge 318 and a second circular edge 320 having an equal number of expansion elements 310, 312, 314, 316 can promote uniform expansion of the frame member 300. Additionally and in some cases, the expansion elements 310, 312, 314, 316 of the first circular edge 318 can be equally spaced around the first circular edge 318, and the expansion elements 310, 312, 314, 316 of the second circular edge 320 can be equally spaced around the second circular edge 320. The equal spacing can also promote uniform expansion of the frame member 300.

[0065] The expansion elements 310, 312, 314, 316 can be configured to maintain the frame element 300 in the second configuration at a diameter to which the internal radial force is applied. For example, the balloon can apply an internal force to the frame element 300 to expand the frame element 300 to a given diameter. After the balloon is no longer inflated, the expansion elements 310, 312, 314, 316 maintain the frame element 300 at the given diameter. More force can cause the frame element 300 to expand further. For example, a first force can cause the frame element 300 to expand by 5%, a greater force can cause the frame element 300 to expand by 10%, and a still greater force can cause the frame element 300 to expand by 20% (or more). The frame element 300 can be expanded and maintained by the expansion elements 310, 312, 314, 316 in an inclined manner so that the frame element 300 can be expanded and maintained at a desired diameter linearly or gradually. In some cases, the frame element 300 can be between about 10 mm and about 20 mm in the first configuration and expand to about 20 mm to about 30 mm in the second configuration. The expansion elements 310, 312, 314, 316 can be configured to maintain the frame element 300 at a desired diameter to accommodate a desired size of a second valve structure disposed within the frame element 300 after expansion.

[0066] In some cases, after a valved catheter including frame element 300 is placed in a patient's body (e.g., in the heart), and after a force is applied inside frame element 300 to stretch, thereby radially expanding the frame element to a second configuration having a larger diameter than the first configuration, a second valve structure or replacement valve structure (having leaflets and configured similarly to valve structure 104) can be placed inside the expanded frame element 300. The second valve structure or replacement valve structure can be implanted via a transcatheter approach and function as an expansion inside frame element 300.

[0067] Figure 4A 1 and 2 , to form a valved catheter. In other cases, the frame element 300 can be deployed within a patient's body without being deployed within a catheter. As shown, the frame element 300 can define an arch or U-shape. The frame element 300 can also include one or more commissure posts 302, 304, 306. The number of commissure posts 302, 304, 306 (or commissure regions or supports) can be equal to the number of leaflets of the valve structure 104 that the frame element 300 is configured to support. As shown in FIG. Figure 4AAs shown, frame element 300 includes three commissure posts 302, 304, 306. Commissure posts 302, 304, 306 can provide locations for attaching leaflets. In some cases, frame element 300 includes a first circular edge 318 and a second circular edge 320 connected by commissure posts 302, 304, 306.

[0068] In some cases, the frame member 300 is configured to expand to Figure 4A In this first configuration, frame member 300 is configured to support valve structure 104 at a first deployed diameter. Valve structure 104 and leaflets 106 (shown in FIGS. 1-2 ) can open and close when deployed at a target location in a patient, such as replacing a portion of a pulmonary valve and a corresponding pulmonary artery.

[0069] In some cases, the valve structure 104 and the leaflets 106 (shown in FIGS. 1-2 ) may no longer function as desired due to growth of the patient, calcification of the leaflets 106, or other issues. As a result, the frame element 300 is configured to move in a second configuration ( Figure 4B The force may be a result of the balloon expanding the frame element 300 or the delivery system carrying the replacement valve structure or the second valve structure 104. The replacement valve structure or the second valve structure 104 may be deployed within the expanded frame element 300.

[0070] To facilitate expansion of the frame member 300 (and the catheter 102 in which the frame member 300 may be implanted), the frame member 300 may include one or more expansion members 310, 312, 314, 316. Figure 4A -B. The expansion elements 310, 312, 314, 316 can be arranged adjacent to one or more commissure posts 302, 304, 306 and configured to expand to radially expand the frame element 300 during the transition between the first configuration and the second configuration. As shown, the expansion elements 310, 312, 314, 316 are arranged at the upper and lower portions of the commissure posts 302, 304, 306. In some cases, each of the commissure posts 302, 304, 306 includes upper and lower expansion elements 310, 312, 314, 316, and in other cases, one or more of the commissure posts 302, 304, 306 includes upper and lower expansion elements 310, 312, 314, 316. In addition, one or more of the commissure posts 302, 304, 306 can include only one of the upper and lower expansion elements 310, 312, 314, 316.

[0071] The upper expansion elements 312, 314 may include a first portion 430 and a second portion 432. Each of the first portion 430 and the second portion 432 of the upper expansion elements 312, 314 includes arms on either side of an adjacent one of the commissure posts 302, 304, 306. Figure 4B As shown, the arms of the first portion 430 and the second portion 432 of the upper dilating elements 312, 314 are separated from the adjacent one of the commissure posts 302, 304, 306 in the second (expanded) configuration. The lower dilating elements 310, 316 may include an accordion-shaped portion that collapses toward the adjacent one of the commissure posts 302, 304, 306 in the first configuration. In the second configuration, as shown Figure 4B As shown, the lower expansion elements 310, 316 expand outwardly relative to the adjacent one of the commissure posts 302, 304, 306. The accordion-shaped portion may include a curved transition between linear shapes. Figure 2 As shown, either or both of the upper and lower expansion elements 310, 312, 314, 316 may include a triangular shape or other curved shape to facilitate expansion. Figure 4B As shown, the frame member 300 maintains an uninterrupted or continuous outer perimeter in the second configuration. The expansion members 310, 312, 314, 316 are configured to expand the frame member 300 without rupturing or otherwise disrupting the physical integrity of the frame member 300.

[0072] The frame member 300 having upper and lower expansion elements 310, 312, 314, 316 can isolate deformation of the frame member 300 between the commissure posts 302, 304, 306. Thus, the frame member 300 is configured to deform to maintain a gap between the leaflets (e.g., Figure 1B ). The upper and lower expansion elements 310, 312, 314, 316 can be configured to maintain the frame element 300 in the second configuration at a diameter for which the internal radial force is applied. The frame element 300 can be expanded and maintained by the upper and lower expansion elements 310, 312, 314, 316 in an inclined manner so that the frame element 300 can be linearly or gradually expanded and maintained at a desired diameter.

[0073] In some cases, after a valved catheter including frame element 300 is placed in a patient's body (e.g., in the heart), and after applying a force from the inside to the frame element 300 to expand, thereby radially expanding the frame element to a second configuration having a larger diameter than the first configuration, a second valve structure or replacement valve structure (having leaflets and configured similarly to valve structure 104) can be placed in the expanded frame element 300. The second valve structure or replacement valve structure can be implanted via a transcatheter approach and function as an expansion within the frame element 300.

[0074] The frame elements discussed herein can be formed of other materials that can be used as the material of the frame, such as stainless steel, L605 steel, polymer, MP35N steel, polymeric material, Pyhnox, Elgiloy (Elgiloy non-magnetic alloy) or any other suitable biocompatible material, and combinations thereof. In other cases, the frame elements can be formed of Nitinol (NiTi).

[0075] The catheter discussed herein can be a synthetic catheter having at least one flexible synthetic valve leaflet attached to the synthetic catheter. Prior to implantation, the synthetic valve leaflets and / or the synthetic catheter can be rinsed in saline and no pre-coagulation is required. Subsequently, the synthetic valve leaflets and the synthetic catheter can be surgically implanted. The synthetic valve leaflets and the synthetic catheter can be a replacement for a natural pulmonary valve or a previously implanted pulmonary valve catheter where it is desired to partially or completely reconstruct the right ventricular outflow tract and / or the main pulmonary artery. In some cases, the installation of the synthetic valve leaflets and the synthetic catheter includes identifying the inflow and outflow regions (or ends) of the catheter, approaching a predetermined position relative to the coronary arteries to ensure that there is no risk of coronary artery compression during implantation, and optionally trimming the inflow and / or outflow ends of the catheter to a length suitable for implantation under moderate tension.

[0076] The valved catheter discussed herein is used to replace the diseased anatomical structure in surgery. Before implantation, the valved catheter can be rinsed in saline and does not need to be coagulated in advance. According to a treatment method, the valved catheter is used as a replacement for a part of the aortic valve and the ascending aorta, such as used in aortic root replacement. Implanting the valved catheter includes identifying the inflow and outflow parts of the catheter, approaching the expected position relative to the anatomical structure, and optionally trimming the inflow end or part and / or outflow end or part of the catheter under the action of moderate (medium) tension to achieve a length suitable for implantation. The ascending aorta is cut open and the inflow part and / or inflow end of the valved catheter are sutured or otherwise connected to the left ventricle of the adjacent resected aortic valve or to replace the resected aortic valve. The outflow part and / or outflow end of the valved catheter are sutured to the cut ascending aorta. The coronary arteries are allowed to remain on the ascending aorta, or they can be sutured to the outflow part of the catheter, and a flow path from the catheter cavity to the coronary arteries is provided.

[0077] According to another method for treating aortic valve disease by replacing the aortic root of a patient, the method includes the following steps: providing a valved catheter according to an embodiment of the present invention and surgically implanting the valved catheter. The method may also include identifying the inflow portion (or end) and the outflow portion (or end) of the catheter; approaching the expected position relative to the anatomical structure; optionally, trimming the inflow portion (or end) and the outflow portion (or end) of the catheter to a length suitable for implantation; optionally, tapering the inflow end outward, or optionally, everting and rolling the inflow portion toward the leaflet structure to define a suture (hoop) sleeve; cutting the ascending aorta; connecting the inflow portion of the valved catheter to the left ventricle adjacent to the resected aortic valve or replacing the resected aortic valve; and, connecting the outflow portion of the valved catheter to the cut ascending aorta. The method may also include connecting the coronary artery to the outflow portion of the catheter; and establishing a flow path from the catheter lumen to the coronary artery.

[0078] In certain embodiments, the catheters discussed herein include an expanded fluoropolymer material made from a porous ePTFE membrane.

[0079] The expandable fluoropolymer used to form the described expanded fluoropolymer material may include a PTFE homopolymer. In alternative embodiments, blends of PTFE, expandable modified PTFE, and / or expanded copolymers of PTFE may be used.

[0080] The expanded fluoropolymer membrane may contain any suitable microstructure, such as pores, to achieve the desired leaflet performance. Other biocompatible polymers suitable for the leaflets include, but are not limited to, polyurethanes, silicones (organopolysiloxanes), copolymers of silicon-polyurethane, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures of the foregoing.

[0081] In various examples, any leaflet construction described herein (e.g., leaflet construction) can be formed from a biocompatible synthetic material (e.g., including ePTFE and ePTFE composites, or other materials as desired). Other biocompatible polymers that may be suitable for use in synthetic leaflets include, but are not limited to, urethanes, silicones (organopolysiloxanes), silicone-urethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures of each of the foregoing.

[0082] In other examples, such leaflet structures are formed from natural materials such as repurposed tissue, including bovine tissue, porcine tissue, and the like.

[0083] As used herein, the term "elastomer" refers to a polymer or polymer mixture that has the ability to stretch to at least 1.3 times its original length and quickly retract to its approximately original length when released. The term "elastomeric material" refers to a polymer or polymer mixture that exhibits stretch and recovery properties similar to an elastomer, but does not necessarily stretch and / or recover to the same degree. The term "non-elastomeric material" refers to a polymer or polymer mixture that exhibits stretch and recovery properties different from an elastomer or elastomeric material, i.e., is not considered an elastomer or elastomeric material.

[0084] According to some embodiments herein, the leaflet structure includes a composite material having at least one porous synthetic polymer film layer with a plurality of pores and / or spaces, and an elastomer and / or elastomeric material and / or non-elastomeric material filling the pores and / or spaces of at least one synthetic polymer film layer. According to other examples, the leaflet structure also includes an elastomer and / or elastomeric material and / or non-elastomeric material layer on the composite material. According to some examples, the composite material includes a porous synthetic polymer film in the range of about 10% to 90% by weight.

[0085] Examples of porous synthetic polymer membranes include expanded fluoropolymer membranes having fibril structures and nodes defining pores and / or spaces. In some examples, the expanded fluoropolymer membrane is an expanded polytetrafluoroethylene (ePTFE) membrane. Another example of a porous synthetic polymer membrane includes a microporous polyethylene membrane.

[0086] Examples of elastomers and / or elastomeric materials and / or non-elastomeric materials include, but are not limited to, copolymers of tetrafluoroethylene and perfluoromethyl vinyl ether (TFE / PMVE copolymers), (per) fluoroalkyl vinyl ethers (PAVE), polyurethanes, silicones (organic polysiloxanes), silicone-polyurethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and various copolymers or mixtures of the foregoing. In some examples, the TFE / PMVE copolymer is an elastomer comprising tetrafluoroethylene substantially between 60 and 20 weight percent and including 60 and 20 weight percent, and corresponding perfluoromethyl vinyl ether between 40 and 80 weight percent and including 40 and 80 weight percent. In some examples, the TFE / PMVE copolymer is an elastic material comprising tetrafluoroethylene substantially between 67 and 61 weight percent and including 67 and 61 weight percent, and corresponding perfluoromethyl vinyl ether between 33 and 39 weight percent and including 33 and 39 weight percent. In some examples, the TFE / PMVE copolymer is a non-elastomeric material comprising tetrafluoroethylene substantially between and including 73 and 68 weight percent and perfluoromethyl vinyl ether correspondingly between and including 27 and 32 weight percent. The TFE and PMVE components of the TFE-PMVE copolymer are expressed in weight percent (%). For reference, 40, 33-39, and 27-32 weight percents of PMVE correspond to 29, 23-28, and 18-22 mole percents, respectively.

[0087] In some examples, the TFE-PMVE copolymer exhibits elastomeric, elastomeric properties, and / or non-elastomeric properties.

[0088] In some examples, the composite material further includes a layer or coating of a TFE-PMVE copolymer containing from 73 to 68 weight percent tetrafluoroethylene and correspondingly from 27 to 32 weight percent perfluoromethylvinyl ether.

[0089] In some examples, the leaflet structure is an expanded polytetrafluoroethylene (ePTFE) membrane into which a TFE-PMVE copolymer has been absorbed, wherein the TFE-PMVE copolymer contains 60 to 20 weight percent tetrafluoroethylene and correspondingly 40 to 80 weight percent perfluoromethyl vinyl ether, and the leaflet structure also includes a coating of a TFE-PMVE copolymer on each blood contacting surface, wherein the TFE-PMVE copolymer contains 73 to 68 weight percent tetrafluoroethylene and correspondingly 27 to 32 weight percent perfluoromethyl vinyl ether.

[0090] As described above, the elastomer and / or elastomeric material and / or non-elastomeric material may be combined with the expanded fluoropolymer membrane such that the elastomer and / or elastomeric material and / or non-elastomeric material occupies substantially all of the empty spaces or pores within the expanded fluoropolymer membrane.

[0091] According to one embodiment, the composite material may include an expanded fluoropolymer material made from a porous ePTFE membrane.

[0092] The expanded fluoropolymer membrane used to form certain of the composites described may include a PTFE homopolymer. In alternative embodiments, blends of PTFE, expandable modified PTFE, and / or expanded copolymers of PTFE may be used.

[0093] The invention of the present application has been described above generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and changes may be made to the embodiments without departing from the scope of the present disclosure. Therefore, the embodiments are intended to cover modifications and changes of the present invention as long as they fall within the scope of the appended claims and their equivalents.

Claims

1. A valved catheter for replacing a bioprosthetic heart valve, comprising: a conduit having an inner surface and an outer surface; as well as a frame element disposed within the catheter and having commissure posts disposed about the frame element, the frame element having a first diameter in a first configuration and configured to support a valve structure having leaflets configured to open to allow flow and close to occlude the catheter lumen and prevent flow in response to a fluid pressure differential, and to expand to a second, larger diameter in a second configuration in response to a force applied to an interior portion of the frame element; as well as one or more expansion elements disposed between or adjacent the commissure posts and configured to expand to radially expand the frame element in transition between the first configuration and the second configuration, Wherein the frame element comprises a first circular edge and a second circular edge connected by the commissure posts, and the one or more expansion elements form part of at least one of the first circular edge and the second circular edge.

2. The valved catheter according to claim 1, characterized in that: The frame element is configured to receive a second valve structure therein in the second configuration.

3. The valved catheter according to claim 1, characterized in that: The one or more expansion elements are arranged with one of the first circular edge and the second circular edge and extend toward the other of the first circular edge and the second circular edge.

4. The valved catheter according to claim 3, characterized in that: The one or more dilation elements include a first linear portion, a second linear portion, and a curved portion.

5. The valved catheter according to claim 4, characterized in that: The first linear portion and the second linear portion extend substantially parallel to a longitudinal axis of the frame element in the first configuration and are configured at an angle relative to the longitudinal axis of the frame element in the second configuration.

6. The valved catheter according to any one of claims 1 to 5, characterized in that: The one or more dilation elements are disposed between the commissure posts.

7. The valved catheter according to any one of claims 1 to 5, characterized in that: The one or more dilation elements are disposed adjacent the commissure posts.

8. The valved catheter according to any one of claims 1 to 5, characterized in that: The one or more dilation elements are disposed between portions of the commissure posts.

9. The valved catheter according to any one of claims 1 to 5, characterized in that: The frame element includes a plurality of commissure posts, and the one or more dilation elements include a plurality of dilation elements disposed between portions of each of the commissure posts.

10. The valved catheter according to claim 9, characterized in that: Also included is a plurality of additional dilation elements disposed between the commissure posts.

11. The valved catheter according to any one of claims 1 to 5 and 10, characterized in that: The one or more expansion elements are configured to increase a diameter of the frame element.

12. An expandable prosthetic device comprising: Valve structure; as well as a frame element configured to support the valve structure in a first configuration and comprising one or more expansion elements configured to radially expand the frame element to a second configuration having a diameter greater than the diameter of the frame element in the first configuration to accommodate a second valve structure in the second configuration and maintain a continuous outer perimeter, Wherein the frame element comprises a first circular edge and a second circular edge, and one or more expansion elements form part of at least one of the first circular edge and the second circular edge.

13. The expandable prosthetic device according to claim 12, wherein: The one or more expansion elements include a first linear portion and a second linear portion, and the first linear portion and the second linear portion extend substantially parallel to the longitudinal axis of the frame element in the first configuration and are configured to be angled relative to the longitudinal axis of the frame element in the second configuration.

14. The expandable prosthetic device of claim 12, wherein: A conduit is also included, and the frame element is disposed within the conduit.

15. A valved catheter for accommodating a first valve structure and allowing expansion to accommodate a second valve structure, the valved catheter comprising: a conduit having an inner surface and an outer surface; as well as a frame element disposed within the catheter, the frame element comprising a first diameter in a first configuration and configured to support a first valve structure having leaflets configured to open to allow flow and close to occlude the catheter lumen and prevent flow in response to a fluid pressure differential, the frame element having: First circular edge, The second circular edge, a commissure post disposed around the frame element and connecting the first circular edge and the second circular edge, an upper dilating element disposed between or adjacent to the commissure posts along the first circular edge, and A lower expansion element is arranged between or adjacent to the commissure posts along the second circular edge, and at least one of the upper expansion element and the lower expansion element is configured to expand in response to a force applied to an inner portion of the frame element to radially expand the frame element in a transition between a larger second diameter in the first structure and the second structure, thereby supporting the second valve structure having leaflets.

16. The valved catheter according to claim 15, characterized in that: The frame element is configured to deform to maintain a gap between the leaflets of the second valve structure.

17. The valved catheter according to claim 15, characterized in that: The upper expansion element and the lower expansion element are configured to maintain the frame element at a diameter acted upon by internal radial forces in the second configuration.

18. The valved catheter according to claim 15, characterized in that: The upper expansion element and the lower expansion element are configured to expand in an inclined manner to allow the frame element to expand linearly.

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