Bioresorbable stent frame structure and docking station

Abstract

Provided herein is a transcatheter aortic or pulmonary valve implant assembly that includes a bioresorbable docking station. The transcatheter valve implant assembly further includes a bioresorbable stent frame structure and a prosthetic valve that is connected with the docking station. This transcatheter valve implant assembly can be implanted adjacent to the aortic valve or pulmonary valve. In some embodiments, the transcatheter valve implant assembly includes a ventricular assist device that is releasably connectable with the bioresorbable docking station and the bioresorbable stent frame structure.

Description

BIORESORBABLE STENT FRAME STRUCTURE AND DOCKING STATIONTECHNICAL FIELD

[0001] The present disclosure relates generally to a transcatheter valve implant assembly having a bioresorbable stent frame structure and a bioresorbable docking station. The present disclosure also relates generally to a transcatheter valve implant assembly having a ventricular assist device that is releasably connectable to the bioresorbable stent frame structure and / or the bioresorbable docking station.BACKGROUND

[0002] One technique that may be used to treat a patient experiencing aortic or pulmonary valve incompetence is valve replacement. However, currently available prosthetic valves typically contain exposed metal components that are in direct contact with the patient’s blood stream. After implantation, these prosthetic valves may be eroded by the flow of blood across these metallic surfaces over time, which may lead to undesirable complications such as thrombus formation. Additionally, existing prosthetic valves may also undesirably migrate after implantation, especially when the native valve being replaced is not stenotic. To address a malpositioned prosthetic valve that has migrated after implantation, the prosthetic valve is typically explanted and replaced with another prosthetic valve, which can lead to undesirable patient complications.

[0003] One technique that may be used to treat a patient experiencing heart failure is implantation of an endovascular ventricular assist devices that facilitate the movement of blood from a ventricle of the patient’s heart and into a corresponding downstream blood vessel (e.g., the aorta or pulmonary artery) of the patient. One issue is that currently available endovascular ventricular assist devices are too small. While the smaller size of such endovascular ventricular assist devices may make transcatheter delivery of the devices easier, upon implantation, these endovascular ventricular assist devices pump a limited volume of blood per unit time, which may be less than an ideal volume for a given patent. Furthermore, currently available endovascular ventricular assist devices also tend to undesirably migrate, which may cause the devices to shift and become malpositioned within the patient after implantation. To address a malpositioned endovascular ventricular assist device that has migrated after implantation, the device is typically explanted and replaced with another endovascular ventricular assist device, which can lead to undesirable patientcomplications.SUMMARY

[0004] With the foregoing in mind, Applicant has developed embodiments of systems and methods related to a transcatheter valve implant assembly that addresses the drawbacks and shortcomings of existing prosthetic valves and / or existing endovascular ventricular assist devices. In some embodiments, the transcatheter valve implant assembly can be used to replace incompetent aortic or pulmonary valves, including both stenotic and non-stenotic valves. The transcatheter valve implant assembly includes a bioresorbable stent frame structure having a prosthetic valve. The bioresorbable stent frame structure may have a larger diameter (e.g., about 2x larger) than currently available prosthetic valves, which can better secure the bioresorbable stent frame structure and prosthetic valve within the patient’s cardiovascular tissue, helping to block or prevent migration of the assembly after implantation. The bioresorbable stent frame structure or prosthetic valve is connected to a bioresorbable docking station at the implantation site via an interlocking mechanism. Portions of the transcatheter valve implant assembly (e g., radial prongs of the bioresorbable docking station, an interlocking mechanism connecting the bioresorbable stent frame structure and the bioresorbable docking station) are in intimate contact with the patient’s tissue, which also helps to block or prevent migration of the assembly after implantation. Additionally, the bioresorbable stent frame structure and the bioresorbable docking station enable gradual bioincorporation after implantation, in which tissue in-growth further secures the assembly in position after implantation. Furthermore, embodiments of the bioresorbable stent frame structure and the bioresorbable docking station of the transcatheter valve implant assembly may lack exposed metal components that are in direct contact with the patient’s bloodstream, which may reduce or eliminate the aforementioned cardiovascular complications of currently available prosthetic valves related to erosion of such exposed metallic components over time. In some embodiments, the transcatheter valve implant assembly includes an endovascular ventricular assist device that is removably attached to the bioresorbable stent frame structure and the bioresorbable docking station. The aforementioned features of the bioresorbable stent frame structure and the bioresorbable docking station enable these components to secure the endovascular ventricular assist device into position, blocking or preventing undesired migration of the endovascular ventricular assist device after implantation. Additionally, the endovascular ventricular assistdevice has a larger diameter (e.g., about 2x larger) than currently available endovascular ventricular assist devices, which enables the endovascular ventricular assist device described herein to pump a larger volume (e g., about 2x larger) of blood per unit time to meet the cardiovascular needs of the patient.

[0005] Provided herein is a transcatheter aortic or pulmonary valve implant assembly having a bioresorbable stent frame structure and a bioresorbable docking station. In some embodiments, the transcatheter valve implant assembly includes a ventricular assist device that is releasably connectable with the bioresorbable docking station and / or the bioresorbable stent frame structure. This valve implant assembly can be implanted across / spanning the aortic valve or pulmonary valve. The ventricular assist device can be powered with a power supply implanted subcutaneously. The transcatheter valve assembly can further include a bioresorbable stent frame structure having a prosthetic valve, in which the bioresorbable stent frame structure is connected with the bioresorbable docking station. In certain embodiments, the transcatheter aortic or pulmonary valve implant assembly includes a bioresorbable stent frame structure. In certain embodiments, the transcatheter aortic or pulmonary valve implant assembly includes a bioresorbable stent frame structure and a bioresorbable docking station. The bioresorbable aspect of the stent frame structure and / or docking station can minimize tissue damage from the persistent presence of artificial parts and can also likely decrease the risk of thrombus formation due to exposure of flowing blood to artificial parts. Moreover, because of biological / living tissue ingrowth with material resorption, the bioresorbable aspect of the stent frame structure and / or docking station can improve stability of positioning (with lack of migration) of the valve implant assembly system. In certain embodiments, several materials can be used as a permanent stent frame for the transcatheter aortic valve. In certain embodiments, the absorbable stent frames can include certain bioabsorbable components with metallic stent frames. In certain embodiments, the bioresorbable stent frame structure and / or the bioresorbable docking station can include metals coated with polymers. Embodiments of the materials include but are not limited to polymers, such as polyethylene terephthalate, polylactic acid, poly-glycolic acid, poly-L-glycolic acid, polycaprolactone, poly-L-lactic acid, polyethylene oxide / polybutylene terephthalate, polyurethane, polycarbonates, phospholipid, hyaluronic acid, and fibrin. Embodiments of the materials include, but are not limited to, metal containing components, such as cobalt-chromium,titanium, tantalum, 316L stainless steel, platinum-chromium, platinum-iridium, nitinol, alloys of magnesium, iron, silicon, and / or carbon, and combinations thereof. Embodiments of the materials include, but are not limited to, metals coated with polymers.

[0006] Provided herein are also methods of implanting a transcatheter valve implant assembly in a patient at an implantation site that can be at least one of an aortic valve and pulmonary valve of a patient. One such embodiment of a method includes implanting a bioresorbable docking station at the implantation site. The method includes introducing a bioresorbable stent frame structure and a prosthetic valve to the implantation site. The method includes engaging native valve leaflets at the implantation site with at least one of the prosthetic valve and the bioresorbable stent frame structure while connecting a proximal end of the bioresorbable stent frame structure to a distal axial face of the bioresorbable docking station in a manner such that the prosthetic valve is adjacent to the proximal end of the bioresorbable stent frame structure. The method includes inserting a ventricular assist device in a hollow interior of a tubular form defined by the bioresorbable stent frame structure such that an inlet of ventricular assist device is positioned in the respective ventricle associated with the implantation site and the outlet of the ventricular assist device is positioned to discharge into the respective blood vessel associated with the implantation site. The method includes releasably connecting the ventricular assist device with the bioresorbable stent frame structure and the bioresorbable docking station.

[0007] Provided herein is also an embodiment of a transcatheter valve implant assembly. The transcatheter valve implant assembly includes a bioresorbable docking station defining a subannular ring having an outer peripheral surface, an inner peripheral surface, and a distal axial face. The outer peripheral surface of the subannular ring has a plurality of radial prongs configured to engage tissue of a patient at an implantation site. The distal axial face of the subannular ring has a distal mounting interlock. The transcatheter valve implant assembly includes a bioresorbable stent frame structure defining a tubular member having a proximal end and a distal end, in which a prosthetic valve is disposed adjacent to the proximal end of the tubular member. The proximal end of the tubular member has a proximal mounting interlock, and the proximal mounting interlock of the bioresorbable stent frame structure is configured to interlock with the distal mounting interlock of the bioresorbable docking station.

[0008] In certain embodiments, the bioresorbable stent frame structure, the bioresorbable dockingstation, or both, include at least one bioresorbable metal coated with at least one bioresorbable polymer. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polyethylene terephthalate. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polylactic acid or poly-L-lactic acid. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include poly-glycolic acid or poly-L-glycolic acid. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polycaprolactone. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polyethylene oxide. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polybutylene terephthalate. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polyurethane. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polycarbonate. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include phospholipid. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include hyaluronic acid. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include fibrin. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include cobalt-chromium. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include titanium. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include tantalum. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include 316L stainless steel. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include platinumchromium. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include platinum-iridium. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include nitinol. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include an alloy containing magnesium, iron, silicon, or carbon.

[0009] In certain embodiments, the proximal mounting interlock of the bioresorbable stent framestructure and the distal mounting interlock of the bioresorbable docking station are configured to interlock by piercing and engaging native valve leaflets at the implantation site. In certain embodiments, the transcatheter valve implant assembly is implanted in the patient at the implantation site, and the proximal mounting interlock of the bioresorbable stent frame structure is interlocked with the distal mounting interlock of the bioresorbable docking station.

[0010] In certain embodiments, the inner peripheral surface of the subannular ring of the bioresorbable docking station has an inner mounting interlock, and the distal end of the tubular member of the bioresorbable stent frame structure has a distal mounting interlock. In certain embodiments, the transcatheter valve implant assembly includes a ventricular assist device having a proximal end and a distal end, the ventricular assist device being configured to extend through the tubular member of the bioresorbable stent frame structure and through the subannular ring of the bioresorbable docking station. The distal end of the ventricular assist device has a distal mounting interlock, and the ventricular assist device has an intermediate mounting interlock arranged intermediate of the proximal and distal ends. The distal mounting interlock of the ventricular assist device is configured to releasably connect to the distal mounting interlock of the bioresorbable stent frame structure, and the intermediate mounting interlock of the ventricular assist device is configured to releasably connect to the inner mounting interlock of the bioresorbable docking station. In certain embodiments, the transcatheter valve implant assembly is implanted in the patient at the implantation site, such that the distal mounting interlock of the ventricular assist device is releasably connected to the distal mounting interlock of the bioresorbable stent frame structure and the intermediate mounting interlock of the ventricular assist device is releasably connected to the inner mounting interlock of the bioresorbable docking station. In certain embodiments, the proximal end of the ventricular assist device has an inlet configured to be positioned inferior to the bioresorbable docking station and within a ventricle of the patient, and the distal end of the ventricular assist device has an outlet configured to be positioned within the tubular member of the bioresorbable stent frame structure, such that the ventricular assist device is configured to draw blood at the inlet and discharge blood from the outlet.

[0011] Provided herein is also an embodiment of a transcatheter valve implant kit. The transcatheter valve implant kit includes a plurality of bioresorbable docking stations, eachbioresorbable docking station of the plurality of bioresorbable docking stations defining a respective subannular ring having a respective outer peripheral surface, a respective inner peripheral surface, and a respective distal axial face. The respective outer peripheral surface of each respective subannular ring has a respective plurality of radial prongs configured to engage tissue of a patient at an implantation site. The respective distal axial face of each respective subannular ring has a respective distal mounting interlock. The transcatheter valve implant kit includes a plurality of bioresorbable stent frame structures, each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures defining a respective tubular member having a respective proximal end and a respective distal end, and a respective prosthetic valve being disposed adjacent to the respective proximal end of each respective tubular member. The respective proximal end of each respective tubular member has a proximal mounting interlock, and the respective proximal mounting interlock of each bioresorbable stent frame structure is configured to interlock with the respective distal mounting interlock of each bioresorbable docking station. Additionally, each bioresorbable docking station of the plurality of bioresorbable docking stations contains a distinct set of one or more bioresorbable materials, and each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures contains a distinct set of one or more bioresorbable materials.

[0012] In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes at least one bioresorbable metal coated with at least one bioresorbable polymer. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polyethylene terephthalate. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polylactic acid or poly-L-lactic acid. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes poly-glycolic acid or poly-L-glycolic acid. In certain embodiments, at least one bioresorbable stent frame structure of the plurality ofbioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes poly caprolactone. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polyethylene oxide. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polybutylene terephthalate. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polyurethane. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polycarbonate. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes phospholipid. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes hyaluronic acid. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes fibrin. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes cobaltchromium. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes titanium. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes tantalum. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station ofthe plurality of bioresorbable docking stations, or both, includes 316L stainless steel. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes platinum-chromium. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes platinum-iridium. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes nitinol. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes an alloy containing magnesium, iron, silicon, or carbon.

[0013] In certain embodiments, the respective inner peripheral surface of the respective subannular ring of each bioresorbable docking station of the plurality of bioresorbable docking stations has a respective inner mounting interlock, and the respective distal end of the respective tubular member of each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures has a respective distal mounting interlock. In certain embodiments, the transcatheter valve implant kit includes a ventricular assist device having a proximal end and a distal end, the distal end of the ventricular assist device having a distal mounting interlock, and the ventricular assist device having an intermediate mounting interlock arranged intermediate of the proximal and distal ends. The distal mounting interlock of the ventricular assist device is configured to releasably connect to the respective distal mounting interlock of each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, and the intermediate mounting interlock of the ventricular assist device is configured to releasably connect to the respective inner mounting interlock of each bioresorbable docking station of the plurality of bioresorbable docking stations.DESCRIPTION OF THE DRAWINGS

[0014] Various aspects of the present disclosure are described hereinbelow with reference to the drawings, which are not necessarily drawn to scale, which are incorporated in and constitute a part of this specification.

[0015] FIG. 1 is an illustration showing an example transcatheter valve implant assemblyimplanted across a pulmonary valve, according to an embodiment.

[0016] FIG. 2 is an illustration showing an example transcatheter valve implant assembly implanted across an aortic valve, according to an embodiment.

[0017] FIG. 3 is a top plan view of one example of a bioresorbable docking station of the transcatheter valve implant assembly, according to an embodiment.

[0018] FIG. 4 is a top plan view of another example of a bioresorbable docking station of the transcatheter valve implant assembly, according to an embodiment.

[0019] FIG. 5 is a partial side cross-section view of the bioresorbable docking station of FIG. 3, according to an embodiment.

[0020] FIG. 6 is a partial side cross-section view of the bioresorbable docking station of FIG. 4, according to an embodiment.

[0021] FIG. 7 is an illustration of the aortic / pulmonary valve prior to implantation of the transcatheter valve implant assembly, according to an embodiment.

[0022] FIG. 8 is an illustration of the aortic / pulmonary valve after to implantation of the transcatheter valve implant assembly, according to an embodiment.

[0023] FIG. 9 is an illustration of one example of a bioresorbable stent frame structure with the bioresorbable docking station of FIG. 3, according to an embodiment.

[0024] FIG. 10 is an illustration of another example of a bioresorbable stent frame structure with the bioresorbable docking station of FIG. 4, according to an embodiment.

[0025] FIG. 11 is an illustration of another example of a bioresorbable stent frame structure with the bioresorbable docking station of FIG. 4, according to an embodiment.

[0026] FIG. 12 is an illustration of the bioresorbable stent frame assembly of FIGS. 9-11 assembled with a respective bioresorbable docking station, according to an embodiment.

[0027] FIG. 13 is an illustration of an example ventricular assist device, according to an embodiment.

[0028] FIG. 14 is a cross-section view of the ventricular assist device of FIG. 13, according to an embodiment.

[0029] FIG. 15 is an illustration of an example of a transcatheter valve implant assembly (including a ventricular assist device) assembled in the aortic / pulmonary valve, according to an embodiment.

[0030] FIG. 16 is an illustration of a subcutaneously implanted power generator for the ventricular assist device, according to an embodiment.

[0031] FIG. 17 is an illustration of the subcutaneous implanted power generator with power leads extending through an auxiliary vein to the ventricular assist device, according to an embodiment.

[0032] FIG. 18 is an illustration a of a transcatheter valve implant kit, according to an embodiment.DETAILED DESCRIPTION

[0033] The present disclosure will now be described more fully hereinafter with reference to example embodiments thereof with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. These example embodiments are described so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. Features from one embodiment or aspect can be combined with features from any other embodiment or aspect in any appropriate combination. For example, any individual or collective features of method aspects or embodiments can be applied to apparatus, product, or component aspects or embodiments and vice versa. The disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. As used in the specification and the appended claims, the singular forms “a,” “an,” “the,” and the like include plural referents unless the context clearly dictates otherwise. In addition, while reference may be made herein to quantitative measures, values, geometric relationships or the like, unless otherwise stated, any one or more if not all of these may be absolute or approximate to account for acceptable variations that may occur, such as those due to manufacturing or engineering tolerances or the like.

[0034] Disclosed herein are devices / assemblies for treatment of heart failure. Certain embodiments include a three component system: (1) an initial bioresorbable docking station (subannular ring) that engages and pins the native aortic valve leaflets, extending into the aortic root / annular / left ventricular outflow tract tissue; (2) a bioresorbable stent frame with a transcatheter aortic valve prosthesis; and (3) a catheter-mounted axial continuous-flow ventricular assist device. In non-stenotic aortic (or pulmonary) valves, the bioresorbable docking station assists with stable engagement of an endovascular prosthesis, recognizing that prostheses often migrate in the absence of the rough surface / friction that stenotic valves provide. This bioresorbabledocking station can create a native aortic (or pulmonary) valve regurgitation / incompetence, so the bioresorbable stent frame addresses this issue and also provides a stable structure into which a larger diameter (e g., 2x larger diameter) than previously clinically implemented ventricular assist device may engage. In certain embodiments, the ventricular assist device is a larger-than-typical (e.g., 2x larger diameter) axial continuous-flow ventricular assist device that engages into the second component, so that it provides high volumetric flow rates and does not migrate.

[0035] Provided herein is a transcatheter aortic or pulmonary valve implant assembly which includes a ventricular assist device that is releasably connectable with a bioresorbable docking station. This valve implant assembly can be implanted adjacent to the aortic valve or pulmonary valve. The ventricular assist device can be powered with a power supply implanted subcutaneously. The transcatheter valve assembly can further include a bioresorbable stent frame structure having a prosthetic valve, in which the bioresorbable stent frame structure is connected with the bioresorbable docking station. In certain embodiments, the transcatheter aortic or pulmonary valve implant assembly includes a bioresorbable stent frame structure. In certain embodiments, the transcatheter aortic or pulmonary valve implant assembly includes a bioresorbable docking station. In certain embodiments, the transcatheter aortic or pulmonary valve implant assembly includes a bioresorbable stent frame structure and a bioresorbable docking station. The bioresorbable aspect of the stent frame structure and / or bioresorbable docking station can minimize tissue damage from the persistent presence of artificial parts and can also likely decrease the risk of thrombus formation due to exposure of flowing blood to artificial parts. Moreover, because of biological / living tissue ingrowth with material resorption, the bioresorbable aspect of the stent frame structure and / or docking station can improve stability of positioning (with lack of migration) of the valve implant assembly system. In certain embodiments, several materials can be used as permanent stent frame for the transcatheter aortic valve. In certain embodiments, the absorbable stent frames can include certain absorbable components with metallic stent frames. In certain embodiments, the bioresorbable stent frame structure and / or the bioresorbable docking station can include metals coated with polymers. Embodiments of the bioresorbable materials include but are not limited to polymers, such as polyethylene terephthalate, polylactic acid, poly- glycolic acid, poly-L-glycolic acid, polycaprolactone, poly-L-lactic acid, polyethylene oxide / polybutylene terephthalate, polyurethane, polycarbonates, phospholipid, hyaluronic acid,and fibrin. Embodiments of the bioresorbable materials include but are not limited to metal containing components, such as cobalt-chromium, titanium, tantalum, 316L stainless steel, platinum-chromium, platinum-iridium, nitinol, alloys of magnesium, iron, silicon, and / or carbon, and combinations thereof. Embodiments of the bioresorbable materials include but are not limited to metals coated with polymers.

[0036] Universally, the components utilized for transcatheter aortic valve implantation are durable. Embodiments described herein are the transcatheter aortic or pulmonary valve implant assembly that includes a bioresorbable stent frame structure, a bioresorbable docking station, or both of a bioresorbable stent frame structure and a bioresorbable docking station. Bioresorbability of the stent frame (at least the components that are not engaged with the bioresorbable docking station) provides several advantages. Particularly if tissue ingrowth is facilitated, then this bioresorbability can further enhance stability of the prosthetic valve mechanism. Moreover, if one were to have to surgically explant the system, it should be simpler to do so in the setting of a tissue- only interface. Explanting conventional transcatheter valve prostheses can be extremely challenging, such that extensive aortic root and ascending thoracic aortic repair / replacement become required.

[0037] FIG. 1 shows an exemplary embodiment of a transcatheter valve implant assembly 20 having a bioresorbable docking station 30, a bioresorbable stent frame structure 32, a prosthetic valve 34 and a ventricular assist device 36 implanted across the pulmonary valve 38 and into the right ventricle 40 of the heart 42. FIG. 2 shows an exemplary embodiment of transcatheter valve implant assembly 20 having the bioresorbable docking station 30, the bioresorbable stent frame structure 32, the prosthetic valve 34, and the ventricular assist device 36 implanted across the aortic valve 44 and into the left ventricle 46 of the heart 42. In some embodiments, the transcatheter valve implant assembly 20 may be deployed via an open surgical technique or endoventricularly via a catheter. For embodiments in which the transcatheter valve implant assembly 20 is deployed endoventricularly via a catheter, the components of the transcatheter valve implant assembly may be deployed using an anterograde technique (in which the catheter moves the components in the same direction as the patient’s blood flow), or using a retrograde technique (in which the catheter moves the components in a direction opposite the patient’s blood flow). For example, in some embodiments, the deployment illustrated in FIG. 1 may be accomplished using an anterogradedeployment technique, in which a catheter is inserted into a suitable vein (e.g., a femoral vein), such that the components of the transcatheter valve implant assembly are delivered through the right atrium and into the right ventricle 40 for assembly at the pulmonary valve 38. In some embodiments, the deployment illustrated in FIG. 2 may be accomplished using a retrograde deployment technique, in which a catheter is inserted into a suitable artery (e.g., a femoral artery), such that the components of the transcatheter valve implant assembly are delivered through the aorta and into the left ventricle 46 for assembly at the aortic valve 44.

[0038] Referring to FIGS. 3-6, the bioresorbable docking station 30 may include a subannular ring 48 that may be deployed via an open surgical technique or endoventricularly via a catheter. The subannular ring 48 may be folded or crimped to allow it to be deployed, and unfurled with a balloon catheter to secure the subannular ring in place in the desired position within the left or right ventricle 46, 40. The subannular ring 48 may be disposed at an implantation site in either the left ventricle 46 in a position upstream of / proximal to the aortic valve 44 or in the right ventricle 40 in a position upstream of / proximal to the pulmonary valve 38. The subannular ring 48 may have radial prongs 50 that extend radially from its outer peripheral or diameter surface 52 when the subannular ring is unfurled in the desired position. The radial prongs 50 may be equiangularly spaced about the outer peripheral or diameter surface 52 of the subannular ring 48. The radial prongs 50 are adapted and configured to anchor the subannular ring 48 into heart tissue. Specifically, with respect to the deployment of the subannular ring 48 in the left ventricle 46 in the position inferior to the aortic valve 44, the radial prongs 50 of the ring may be anchored between the septum and the aortic mitral continuity so as to avoid the mitral valve anterior leaflet. When the subannular ring 48 is deployed in and the right ventricle 40 in the position inferior to the pulmonary valve 38, the radial prongs 50 of the ring may be anchored in the septum and the right ventricle wall in a position that is sufficiently away from the tricuspid valve leaflets. The subannular ring 48 may have an inner peripheral or inner diameter surface 54 with a mounting interlock or locator surface 56 (also referred to herein as an inner mounting interlock) adapted and configured to receive a cooperating surface or mounting interlock 58 of the ventricular assist device 36 (e.g., as illustrated in FIGS. 13 and 14) in a manner to allow the ventricular assist device to be releasably connected to the subannular ring. For instance, the mounting interlock or locator surface 56 on the inner peripheral surface 54 of the subannular ring 48 may have one or more grooves 60, which may be continuous,discontinuous, tapered and / or helical, and that cooperate with a ridge or tabs 62 (e.g., as illustrated in FIGS. 13 and 14), which may be continuous, discontinuous, tapered and / or helical, on the outer surface of the ventricular assist device 36, thereby allowing the ventricular assist device to be releasably connected anchored to the inner peripheral or diameter surface of the subannular ring. The ridge or tabs 62 on the outer surface of the ventricular assist device 36 may have a complementary geometry with the groove(s) 60 on the inner peripheral or inner diameter surface of the subannular ring 48 to allow the ventricular assist device to be releasably connected to the sub annul ar ring.

[0039] The subannular ring 48 may also have a di stal / down stream axial surface 64 with a mounting interlock or locator surface 66 (also referred to herein as a distal mounting interlock) adapted and configured to receive a cooperating mounting interlock or surface 68 (also referred to as a proximal mounting interlock) of the bioresorbable stent frame structure 32 and / or the prosthetic valve 34. In one aspect, the distal / downstream axial surface 64 of the subannular ring 48 may include one or more groove(s) 70 adapted and configured to be connected with one or more cooperating tab, ridge or rib structure(s) 72 (e.g., as illustrated in FIG. 10) projecting axially from the proximal end of the bioresorbable stent frame structure 32 and / or the prosthetic valve 34. In another aspect, the distal / downstream axial surface 64 of the subannular ring 48 may have a plurality of holes 74 adapted to receive pins 76 (e.g., as illustrated in FIG. 9) projecting axially from the proximal end of the bioresorbable stent frame structure 32 and / or the prosthetic valve 34. The holes 74 may be equiangularly spaced about the subannular ring 48. The structure used to connect the subannular ring 48 to the bioresorbable stent frame structure 32 and / or the prosthetic valve 34 is adapted and configured to engage the existing valve structure 38, 44 and / or leaflets of the existing valve structure. For instance, the pins 76 projecting from the bioresorbable stent frame structure 32 and / or the prosthetic valve 34 may extend through the existing valve annular tissue and leaflets into the holes formed on the superior surface of the subannular ring 48. Thus, the existing valve 38, 44 and leaflets are captured and disposed between the subannular ring 48 and the bioresorbable stent frame structure 32 and / or the prosthetic valve 34. FIGS. 7 and 8 illustrate the existing valve 38, 44 and leaflets captured between the subannular ring 48 and the bioresorbable stent frame structure 32 and / or the prosthetic valve 34. The relative configuration of the pins, tabs and / or ridges 72 of the bioresorbable stent frame structure 32 and / or the prosthetic valve 34 and the groove(s) 70 and / orholes 74 of the subannular ring 48 may be reversed so that the bioresorbable stent frame structure and / or prosthetic valve is provided with a groove and / or holes and the distal / downstream axial face of the subannular ring is provided with a system of cooperating pins, tabs and / or ridges.

[0040] FIGS. 9-12 show embodiments of the bioresorbable stent frame structure 32 and the prosthetic valve 34. The bioresorbable stent frame structure 32 and prosthetic valve 34 are implanted in a position superior to the pulmonary valve 38 or the aortic valve 44, as desired. The bioresorbable stent frame structure 32 and prosthetic valve 34 may be deployed via an open surgical technique or endoventricularly via a catheter. In one aspect, the bioresorbable stent frame structure 32 and prosthetic valve 34 may be crimped to allow the assembly to be deployed, passed through the inner peripheral or diameter surface 54 of the subannular ring 48 and positioned superior to the respective valve. The bioresorbable stent frame structure 32 and / or the prosthetic valve 34 may have pins 76 that pierce the native valve leaflets so as to engage holes 74 formed on the superior axial surface of the subannular ring 48, as discussed above. In some embodiments, the prosthetic valve 34 and / or bioresorbable stent frame structure 32 may have a ridge or a rib structure(s) 72 on its proximal end that engages the native leaflets of the existing valve and extend through the leaflets and valve tissue to the groove on the superior axial surface of the subannular ring 48.

[0041] In certain embodiments, the existing heart tissue is disposed between the proximal end of the bioresorbable stent frame structure 32 and / or the prosthetic valve 34 and the subannular ring 48 with the radial prongs 50 of the subannular ring anchoring the assembly in the heart tissue, thereby reducing the likelihood of migration of the bioresorbable stent frame structure 32 and ventricular assist device 36. Applicant further recognized that the bioresorbable aspect of the bioresorbable stent frame structure 32 and / or the bioresorbable docking station 30 further enhances the ability of the radial prongs 50 and the interlock mechanism between the bioresorbable stent frame structure 32 and the bioresorbable docking station 30 (e.g., pins 76 and corresponding holes 74, the ridge or rib structures 72 and corresponding grooves 70) to stabilize the transcatheter valve implant assembly after implantation. It is expected that portions of the transcatheter valve implant assembly having the greatest intimate contact with the tissue of the patient will be more readily resorbed by the patient tissue after implantation. The radial prongs 50 that radially pierce into the tissue adjacent the pulmonary or aortic valves, as well as the interlock mechanism between thebioresorbable stent frame structure 32 and the bioresorbable docking station 30 (e.g., pins 76 and corresponding holes 74, the ridge or rib structures 72 and corresponding grooves 70) that engages the leaflets of the native valve, represent regions of the transcatheter valve implant assembly that will experience accelerated resorption relative to other portions of the assembly. Accordingly, the Applicant recognized the bioresorbable aspect of the bioresorbable stent frame structure 32 and / or the bioresorbable docking station 30 enables tissue in-growth particularly in key regions that secure the transcatheter valve implant assembly in position within the implantation site, decreasing the likelihood of the transcatheter valve implant assembly will shift or migrate after implantation. Furthermore, for situations in which the transcatheter valve implant assembly is later explanted from a patient (e.g., using an open surgical technique, or endoventricularly via a catheter), the assembly may be removed primarily by incising the in-grown patient tissue, as opposed to cutting portions of the assembly itself, which eases the removal process and reduces the risk of complications to the patient.

[0042] In some embodiments, the transcatheter valve implant assembly may be deployed without the ventricular assist device 36. For example, stenotic or non-stenotic valve incompetence may be observed in a patient’s pulmonary valve or aortic valve, while the patient is not experiencing symptoms of heart failure. Accordingly, in some implementations, the transcatheter valve implant assembly may include only the bioresorbable docking station 30 and the bioresorbable stent frame structure 32, in which the bioresorbable stent frame structure 32 includes the prosthetic valve 34. Applicant recognized that the additional rigidity and stiffness typically imparted to stenotic valves by the accumulation of calcium deposits can actually help to better secure a prosthetic valve, while non-stenotic incompetent valves tend to be more pliable and flexible, which can make installation of prosthetic valves more difficult. Accordingly, Applicant recognized that the bioresorbable docking station 30 and the bioresorbable stent frame structure 32 enables implantation of a prosthetic valve 34 to address incompetent pulmonary or aortic valves, including both stenotic valves and non-stenotic valves. As discussed, the design of, and the tissue in-growth promoted by, the bioresorbable aspect of the bioresorbable docking station 30 and / or the bioresorbable stent frame structure 32 enables enhanced stability to the implanted transcatheter valve implant assembly to treat patients experiencing incompetent pulmonary or aortic valves. Furthermore, for such implementations, the transcatheter valve implant assembly enables treatment flexibility, suchthat a patient can first be implanted with the transcatheter valve implant assembly (without a ventricular assist device) to address an incompetent pulmonary or aortic valve, and the ventricular assist device may be subsequently implanted and attached to the implanted bioresorbable docking station 30 and bioresorbable stent frame structure 32 at a later time to treat heart failure, in accordance with the evolving medical needs of the patient.

[0043] The distal end of the bioresorbable stent frame structure 32 may include a mounting interlock or locator surface 78 (also referred to herein as a distal mounting interlock) that is adapted and configured to receive a cooperating mounting interlock or surface 80 of the ventricular assist device 36 in a manner to allow the ventricular assist device to be releasably connected to the distal end of the bioresorbable stent frame structure 32. For instance, the mounting interlock or locator surface 78 on an inner peripheral or inner diameter surface at or adjacent to the distal end of the bioresorbable stent frame structure 32 may have a groove 82, which may be continuous, discontinuous, tapered and / or helical, that cooperates with a ridge or tabs 84, which may be continuous, discontinuous, tapered and / or helical, on the outer surface of the ventricular assist device 36, thereby allowing the ventricular assist device to be releasably connected the inner peripheral or diameter surface at or adjacent to the distal end of the bioresorbable stent frame structure 32. The ridge or tabs 84 on the distal end of the ventricular assist device 36 may have a complementary geometry with the groove(s) 82 on the inner diameter surface of the bioresorbable stent frame structure 32 to allow the ventricular assist device to be releasably connected to the bioresorbable stent frame structure 32. In the alternative, the distal end of the bioresorbable stent frame structure 32 may have pins extending radially inward from an inner peripheral or inner diameter surface at or adjacent to the distal end of the bioresorbable stent frame structure 32, and the inward extending radial pins may engage the outer diameter surface of the ventricular assist device 36 to support the distal end of the ventricular assist device in the respective artery.

[0044] FIGS. 13 and 14 show embodiments of the ventricular assist device 36. The ventricular assist device 36 is adapted and configured to be disposed within the bioresorbable stent frame structure 32 and extend through the prosthetic valve 34 and the existing valve, and into the respective ventricle with a releasable connection to the subannular ring 48, for instance, as shown in FIG. 15. The ventricular assist device 36 may have a proximal end with a suction inlet port 86 disposed in the respective ventricle, and a distal end with an outlet port 88 disposed in therespective pulmonary artery or aorta. The ventricular assist device 36 may have a mounting interlock or locator surface 58 on its outer diameter surface in a region intermediate of the proximal and distal ends that cooperates with the mounting interlock or locator surface on the inner diameter surface of the subannular ring 48 and positions the ventricular assist device so that the suction inlet port 86 of the ventricular assist device is disposed within the respective ventricle. The locator surface 58 on the outer diameter surface in the intermediate region of the ventricular assist device 36 may be tabs, ridges, or ribs 62 that engage the groove(s) 60 of the inner diameter surface of the subannular ring 48. The tabs or ribs 62 on the outer diameter and intermediate surface of the ventricular assist device 36 and the groove(s) 60 on the inner diameter surface of the subannular ring 48 may be shaped and sized (helically shaped or tapered) to allow the ventricular assist device to be rotated about its center axis in one direction through a particular angular rotation (e.g., a quarter turn or half-turn) to engage the tabs or ribs with the groove of the subannular ring, and rotated about its center axis in the opposite direction through a particular angular rotation (e.g., a quarter turn or half-turn) to disengage the tabs or ribs with the groove of the subannular ring.

[0045] The distal end of the ventricular assist device 36 may have a mounting interlock or locating surface 80 that engages the mounting interlock 78 at the distal end of the bioresorbable stent frame structure 32, thereby anchoring the ventricular assist device in position with the outflow of the ventricular assist device in the respective main artery, for instance, the aorta or the pulmonary artery. The mounting interlock or locator surface 80 on the distal end of the ventricular assist device 36 may be tabs, ridges, or ribs 84 that engage a groove 82 of the inner diameter surface at the locator surface 78 at the distal end of the bioresorbable stent frame structure 32. The tabs or ribs 84 on the distal end outer diameter surface of the ventricular assist device 36 and the groove 82 on the inner diameter surface of the bioresorbable stent frame structure 32 may be shaped and size (helically shaped or tapered) to allow the ventricular assist device to be rotated about its center axis in one direction through a particular angular rotation (e.g., a quarter turn or half-turn) to engage the tabs or ribs with the groove of the bioresorbable stent frame structure 32, and rotated about its center axis in the opposite direction through a particular angular rotation (e.g., a quarter turn or half-turn) to disengage the tabs or ribs with the groove of the bioresorbable stent frame structure 32. The distal end of the ventricular assist device 36 may also be provided with a groove or holes to engage pins extending radially inward from the inner diameter surface at or adjacent to the distalend of the bioresorbable stent frame structure 32. The ventricular assist device may include helical style impeller 90 that is connected to a shaft 92 and a motor 94.

[0046] The ventricular assist device 36 may be powered by an electrical system for instance a power cable 96 that is supplied via a subcutaneous implanted generator 98. The ventricular assist device 36 may be adapted and configured to be deployed endovascularly with a catheter and unfurled or expanded once in place with a balloon catheter. Accordingly, the ventricular assist device 36 may be crimped for deployment until in position in the bioresorbable stent frame structure 32, and then expanded to engage the bioresorbable stent frame structure. In another aspect, the ventricular assist device 36 may be assembled in position in the bioresorbable stent frame structure 32 with one or more pieces of the ventricular assist device crimped for deployment endovascularly and un-furled or expanded in the place, and then assembled within the bioresorbable stent frame structure 32 to form the ventricular assist device. For instance, the casing and / or impeller 90 and / or motor 94 of the ventricular assist device 36 may be separately crimped for deployment endovascularly and sequentially assembled at least partially within the bioresorbable stent frame structure 32. In another aspect, the bioresorbable stent frame structure 32 may include portions of the ventricular assist device 36, and other portions of the ventricular assist device may be deployed and assembled at least partially with the bioresorbable stent frame structure as needed. In another aspect, the ventricular assist device 36 and / or portions of the ventricular assist device may be deployed through an open surgical technique with the power cable 96 deployed endovascularly through a peripheral artery or vein.

[0047] FIG. 15 shows the transcatheter valve implant assembly with ventricular assist device 36 releasably connectable to the bioresorbable docking station 30. The ventricular assist device 36 is positioned within the bioresorbable stent frame structure 32 and extends through the existing valve and subannular ring 48 into the respective ventricle with the outlet port 88 (as indicated in FIGS. 13 and 14) directed to a respective artery and the suction inlet port 86 positioned in the respective ventricle. Depending upon the location of the ventricular assist device 36, the power cable 96 may be directed via a peripheral (e.g., auxiliary) artery or (e.g., auxiliary) vein, for instance, as illustrated in FIG. 16. To assist in anchoring the power cable 96, a ring 100 may be implanted in the wall of the artery or the vein to ensure that the power cable maintains position while maintaining the structural integrity of the respective vein or artery, for instance, as shown in FIG. 17.

[0048] Each of the devices may be deployed sequentially beginning with the subannular ring 48, next with prosthetic valve 34 and the bioresorbable stent frame structure 32 (either together as assembly or separately), and ending with the ventricular assist device 36. By providing a ventricular assist device 36 that may be releasably connected with the subannular ring 48 and the bioresorbable stent frame structure 32, the ventricular assist device may be replaced as needed. For instance, the existing ventricular assist device 36 may be detachably connected to the distal end of the bioresorbable stent frame structure 32 and / or the subannular ring 48 and removed endoventricularly. A replacement ventricular assist device 36 may be inserted endoventricularly and releasably connected to the existing subannular ring 48 and the distal end of the bioresorbable stent frame structure 32.

[0049] In some embodiments, the components of the transcatheter valve implant assembly 20 may be provided to a medical professional in the form of a kit. For example, FIG. 18 illustrates an embodiment of a transcatheter valve implant kit 110 that includes a set 112 of bioresorbable docking stations, a set 114 of bioresorbable stent frame structures, a ventricular assist device 116, and a power generator 118. In some embodiments, each bioresorbable docking station of the set 112 may be formed from a distinct set of one or more bioresorbable materials, and each bioresorbable stent frame structure of the set 114 may be formed from a distinct set of one or more bioresorbable materials. In some embodiments, the transcatheter valve implant kit 110 may additionally or alternatively include different sizes of bioresorbable docking stations in the set 112 and different sizes of bioresorbable stent frame structures in the set 114 to accommodate anatomical variations of different patients.

[0050] Applicant recognized that certain bioresorbable materials may be better suited to the treatment of particular patients. For example, a bioresorbable material may be suitable for the treatment of one patient, while the same bioresorbable material may elicit a detrimental response (e g., an immune response, an allergic reaction) in another patient. Accordingly, the medical professional may conduct suitable testing (e g., immunological testing, allergy testing) in advance of treatment to facilitate the selection of a suitable bioresorbable materials for implantation in a particular patient.

[0051] Furthermore, Applicant recognized that various bioresorbable materials offer widely different materials properties, such as elasticity, flexibility, rigidity, compressibility, and so forth.As a result, Applicant recognized that certain aspects of deployment, such as how tightly a particular bioresorbable docking station and / or a particular bioresorbable stent frame structure may be compressed for transcatheter implantation, may vary for different bioresorbable materials. Additionally, Applicant recognized that the material properties of certain bioresorbable materials may increase or decrease the difficultly of interlocking the components of the transcatheter valve implant assembly during implantation.

[0052] For example, for embodiments of the transcatheter valve implant assembly in which the interlock between the bioresorbable stent frame structure and the bioresorbable docking station includes pins 76 and corresponding holes 74, Applicant recognized that bioresorbable materials having too much flexibility and too little rigidity may result in substantial movement or deflection of the pins 76 during assembly within the implantation site of the patient, which may make it more challenging to align and insert the pins into the holes 74 to interlock the components. In contrast, for embodiments of the transcatheter valve implant assembly in which the interlock between the bioresorbable stent frame structure 32 and the bioresorbable docking station 30 includes corresponding ridges or ribs 72 and a corresponding groove 70, the ridges or ribs 72 are each formed from a larger volume of bioresorbable material relative to the pins 76. Accordingly, the ridges or ribs 72 may demonstrate reduced movement or deflection during assembly within the implantation site of the patient, relative to pins 76 formed from the same bioresorbable material. Therefore, Applicant recognized that certain implementations of the transcatheter valve implant assembly (e.g., embodiments with interlocking mechanisms including pins 76) may be more sensitive to the effects that result from the material properties of certain bioresorbable materials. Additionally, Applicant recognized that, in some implementations, it may be desirable for the bioresorbable docking station and the bioresorbable stent frame structure selected for implantation to be made from the same set of bioresorbable material, which may ensure that the material properties of the bioresorbable docking station and the bioresorbable stent frame structure are matched, while limiting the number of bioresorbable materials being introduced into the patient to reduce the likelihood of patient complications. The transcatheter valve implant kit 110 enables the medical professional to select a suitable bioresorbable docking station and a corresponding suitable bioresorbable stent frame structure from the kit for implantation within a patient based on various considerations, such as the material properties of the bioresorbable materials and / or the suitabilityof particular bioresorbable materials to the treatment of the patient. Accordingly, the transcatheter valve implant kit 110 enables the medical professional to mix and match the various bioresorbable materials and / or sizes of the bioresorbable stent frame structure and the bioresorbable docking station, thereby to yield a transcatheter valve implant assembly that is customizable to a particular patient.

[0053] In the description above, the principle and embodiments of the present application are illustrated herein by specific examples. The description of the above embodiments is only intended to facilitate the understanding of the method and the concept of the present application. For those skilled in the art, changes can be made to specific embodiments and an application scope of the present application, according to the concepts of the application. In conclusion, contents of the specification should not be construed as limitation to the present application.

[0054] Provided herein is a transcatheter valve implant assembly that includes a ventricular assist device, a prosthetic valve, a bioresorbable stent frame structure, and a bioresorbable docking station. The transcatheter valve implant assembly is adapted and configured to be implanted in a patient at an implantation site, which can be at least one of an aortic valve and pulmonary valve of a patient. The ventricular assist device has a proximal end with an inlet and a distal end with an outlet, and is adapted and configured to draw blood at the inlet and discharge blood from the outlet. The ventricular assist device has a first mounting interlock on its distal end and a second mounting interlock arranged intermediate of the proximal and distal ends. The bioresorbable docking station has an outer peripheral surface adapted and configured to engage tissue of the patient at the implantation site. Moreover, the bioresorbable docking station has an inner peripheral surface with an inner surface mounting interlock and a distal axial face with a mounting interlock. The bioresorbable stent frame structure has a proximal end and a distal end, the proximal end of the bioresorbable stent frame structure having a mounting interlock, the distal end of the bioresorbable stent frame structure having a mounting interlock. When the transcatheter valve implant assembly is implanted in a patient at the implantation site: (i) the bioresorbable stent frame structure defines a tubular member with the ventricular assist device positioned within the bioresorbable stent frame structure, (ii) the bioresorbable docking station defines a subannular ring with the outer peripheral surface of the bioresorbable docking station engaged with tissue of the patient at the implantation site, (iii) the inlet of ventricular assist device is positioned in the respective ventricle associatedwith the implantation site and the outlet of the ventricular assist device is positioned to discharge into a respective blood vessel associated with the implantation site, (iv) the first mounting interlock of the ventricular assist device is releasably connected to the distal end mounting interlock of the bioresorbable stent frame structure; (v) the second mounting interlock of the ventricular assist device is releasably connected to the inner peripheral surface mounting interlock of the bioresorbable docking station, (vi) the mounting interlock of the proximal end of the bioresorbable stent frame structure is interlocked with the mounting interlock of the distal axial face of the bioresorbable docking station, (vii) the prosthetic valve is disposed adjacent the proximal end of the bioresorbable stent frame structure; and (viii) the prosthetic valve is disposed at least one of adjacent to and against the distal axial face of the bioresorbable docking station.

[0055] In certain embodiments, the bioresorbable docking station is adapted and configured to be folded or crimped to facilitate endoventricular delivery and deployment of the bioresorbable docking station at the implantation site. In certain embodiments, the bioresorbable docking station is adapted and configured to be unfurled with a balloon catheter to enable the outer peripheral surface of the bioresorbable docking station to engage the patient’s tissue at the implantation site. In certain embodiments, the outer peripheral surface of the bioresorbable docking station includes a plurality of prongs projecting outward from the outer peripheral surface to engage the patient’s tissue at the implantation site when the bioresorbable docking station is unfurled at the implantation site. In certain embodiments, the inner surface mounting interlock of the inner peripheral surface of the bioresorbable docking station and the second mounting interlock of ventricular assist device include a cooperating groove and tab adapted and configured to releasably connect the second mounting interlock of the ventricular assist device to the mounting interlock of the inner peripheral surface of the bioresorbable docking station when the transcatheter valve implant assembly is implanted in a patient at the implantation site. In certain embodiments, the first mounting interlock of the ventricular assist device and the mounting interlock of the distal end of the bioresorbable stent frame structure include a cooperating groove and tab adapted and configured to connect the first mounting interlock of the ventricular assist device with the mounting interlock of the distal end of the bioresorbable stent frame structure when the transcatheter valve implant assembly is implanted in a patient at the implantation site. In certain embodiments, the mounting interlock of the distal axial face of the bioresorbable docking stationand the mounting interlock of the proximal end of the bioresorbable stent frame structure include a cooperating groove and tab adapted and configured to connect the mounting interlock of the distal axial face of the bioresorbable docking station with the mounting interlock of the proximal end of the bioresorbable stent frame structure when the transcatheter valve implant assembly is implanted in a patient at the implantation site. In certain embodiments, the mounting interlock of the distal axial face of the bioresorbable docking station engages the prosthetic valve when the transcatheter valve implant assembly is implanted in a patient at the implantation site.

[0056] In certain embodiments, the prosthetic valve is formed with the bioresorbable stent frame structure adjacent to the proximal end of the bioresorbable stent frame structure. In certain embodiments, the mounting interlock of the distal axial face of the bioresorbable docking station and the mounting interlock of the proximal end of the bioresorbable stent frame structure include cooperating pins and holes adapted and configured to connect the mounting interlock of the distal axial face of the bioresorbable docking station with the mounting interlock of the proximal end of the bioresorbable stent frame structure when the transcatheter valve implant assembly is implanted in a patient at the implantation site. In certain embodiments, the ventricular assist device further includes a helical style impeller connected to a shaft and a motor. In certain embodiments, the ventricular assist device is powered by a power cable that is supplied via a subcutaneous implanted generator.

[0057] Provided herein are also methods of implanting a transcatheter valve implant assembly in a patient at an implantation site that can be at least one of an aortic valve and pulmonary valve of a patient. One such method includes the steps of: implanting a bioresorbable docking station at the implantation site; introducing a bioresorbable stent frame structure and a prosthetic valve to the implantation site; engaging native valve leaflets at the implantation site with at least one of the prosthetic valve and the bioresorbable stent frame structure while connecting a proximal end of a bioresorbable stent frame structure to a distal axial face of the bioresorbable docking station in a manner such that the prosthetic valve is adjacent to the proximal end of the bioresorbable stent frame structure; inserting a ventricular assist device in a hollow interior of a tubular form defined by the bioresorbable stent frame structure such that an inlet of ventricular assist device is positioned in the respective ventricle associated with the implantation site and the outlet of the ventricular assist device is positioned to discharge into the respective blood vessel associated withthe implantation site; and releasably connecting the ventricular assist device with the bioresorbable stent frame structure and the bioresorbable docking station.

[0058] In certain embodiments, the step of introducing the bioresorbable stent frame structure and the prosthetic valve to the implantation site includes folding or crimping at least one of the bioresorbable stent frame structure and the prosthetic valve and delivering the at least one of the bioresorbable stent frame structure and the prosthetic valve via a catheter to the implantation site. In certain embodiments, the step of folding or crimping at least one of the bioresorbable docking station and the ventricular assist device and delivering the at least one of the bioresorbable docking station and the ventricular assist device via a catheter to the implantation site.

[0059] In certain embodiments, the step of engaging native valve leaflets at the implantation site with at least one of the prosthetic valve and the bioresorbable stent frame structure includes arranging a cooperating groove and tab of a mounting interlock of the distal axial face of the bioresorbable docking station and a mounting interlock of the proximal end of the bioresorbable stent frame structure to engage the native leaflets while connecting the proximal end of the bioresorbable stent frame structure to the distal axial face of the bioresorbable docking station. In certain embodiments, the step of engaging native valve leaflets at the implantation site with at least one of the prosthetic valve and the bioresorbable stent frame structure includes arranging cooperating pins and holes of a mounting interlock of the distal axial face of the bioresorbable docking station and a mounting interlock of the proximal end of the bioresorbable stent frame structure to engage the native leaflets while connecting the proximal end of the bioresorbable stent frame structure to the distal axial face of the bioresorbable docking station.

[0060] In certain embodiments, the step of engaging native valve leaflets at the implantation site with at least one of the prosthetic valve and the bioresorbable stent frame structure includes connecting a cooperating groove and ridge of the distal axial face of the bioresorbable docking station and the prosthetic valve together such that the prosthetic valve is adjacent to the proximal end of the bioresorbable stent frame structure and the distal axial face of the bioresorbable docking station with the native leaflets between the prosthetic valve and the distal axial face of the bioresorbable docking station.

[0061] In certain embodiments, the method can further include the step of aligning the ventricular assist device to receive power via a subcutaneous implanted generator. In certain embodiments,the method can further include the step of inserting a power cable for the ventricular assist device through at least one of an auxiliary vein and artery. In certain embodiments, the step of implanting the bioresorbable docking station at the implantation site includes unfurling the bioresorbable docking station with a balloon catheter and urging an outer peripheral surface of the bioresorbable docking station to engage the patient’s tissue at the implantation site. In certain embodiments, when the implantation site includes the aortic valve, the step of implanting the bioresorbable docking station at the implantation site includes engaging the patient’s tissue at the aortomitral continuity and the septum at the left ventricular outflow tract tissue, and when the implantation site includes the pulmonary valve, the step of implanting the bioresorbable docking station at the implantation site includes engaging the patient’s tissue right ventricular outflow tract tissue and the septum.

[0062] In certain embodiments, the step of releasably connecting the ventricular assist device with the bioresorbable stent frame structure and the bioresorbable docking station includes: releasably connecting a mounting interlock at a distal end of the ventricular assist device with a mounting interlock at a distal end of the bioresorbable stent frame structure; and releasably connecting a mounting interlock intermediate of a proximal end and the distal end of the ventricular assist device with a mounting interlock on an peripheral inner surface of the bioresorbable docking station.

[0063] Provided herein is a transcatheter valve implant assembly including a ventricular assist device, a prosthetic valve having a bioresorbable stent frame structure, and a bioresorbable docking station for the bioresorbable stent frame structure and the ventricular assist device. In certain embodiments, when the transcatheter valve implant assembly is implanted in a patient at one of an aortic valve and pulmonary valve of the patient, the bioresorbable docking station includes a subannular ring, the subannular ring has an inner diameter surface with a locator surface adapted and configured to receive a cooperating surface of the ventricular assist device such that the ventricular assist device is releasably connected to the subannular ring, the subannular ring having a distal axial surface with a locator surface adapted and configured to receive a cooperating surface of one of the bioresorbable stent frame structure and the prosthetic valve such that the one of the bioresorbable stent frame structure and the prosthetic valve is connected to the subannular ring, and the ventricular assist device being positionable within the bioresorbable stent frame structure and releasably connectable with the bioresorbable stent frame structure and the bioresorbabledocking station.

[0064] In certain embodiments, the bioresorbable docking station is adapted and configured to be folded or crimped to facilitate deployment of the bioresorbable docking station prior to implantation. In certain embodiments, the bioresorbable docking station is adapted and configured to be unfurled with a balloon catheter to secure the bioresorbable docking station in a desired position within the respective left or right ventricle when the transcatheter valve implant assembly is implanted in a patient. In certain embodiments, the bioresorbable docking station has an outer diameter surface including prongs adapted and configured to anchor the bioresorbable docking station into heart tissue when the transcatheter valve implant assembly is implanted in a patient.

[0065] In certain embodiments, the locator surface of the inner diameter surface of the bioresorbable docking station includes a groove, and the cooperating surface of the ventricular assist device includes a ridge, the groove and the ridge being adapted and configured to cooperate, such that the ventricular assist device is releasably anchored to the inner diameter surface of the bioresorbable docking station when the transcatheter valve implant assembly is implanted in a patient. In certain embodiments, the locator surface of the distal axial surface of the bioresorbable docking station includes one or more grooves, and the cooperating surface of one of the bioresorbable stent frame structure and the prosthetic valve includes a ridge, the groove and the ridge being adapted and configured to cooperate, such that the one of the bioresorbable stent frame structure and the prosthetic valve is releasably anchored to the inner diameter surface of the bioresorbable docking station when the transcatheter valve implant assembly is implanted in a patient.

[0066] In certain embodiments, the distal axial surface of the bioresorbable docking station includes a plurality of holes being adapted to receive pins projecting axially from the proximal end of one of the bioresorbable stent frame structure and the prosthetic valve to facilitate the connection of the bioresorbable docking station to the one of the bioresorbable stent frame structure and prosthetic valve when the transcatheter valve implant assembly is implanted in a patient. In certain embodiments, the plurality of holes is equiangularly spaced about the bioresorbable docking station. In certain embodiments, the ventricular assist device further includes a helical style impeller connected to a shaft and a motor. In certain embodiments, the ventricular assist device is powered by a power cable that is supplied via a subcutaneous implanted generator.

[0067] Provided herein is an embodiment of a transcatheter valve implant assembly. The transcatheter valve implant assembly includes a bioresorbable docking station defining a subannular ring having an outer peripheral surface, an inner peripheral surface, and a distal axial face. The outer peripheral surface of the subannular ring has a plurality of radial prongs configured to engage tissue of a patient at an implantation site. The distal axial face of the subannular ring has a distal mounting interlock. The transcatheter valve implant assembly includes a bioresorbable stent frame structure defining a tubular member having a proximal end and a distal end, in which a prosthetic valve is disposed adjacent to the proximal end of the tubular member. The proximal end of the tubular member has a proximal mounting interlock, and the proximal mounting interlock of the bioresorbable stent frame structure is configured to interlock with the distal mounting interlock of the bioresorbable docking station.

[0068] In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include at least one bioresorbable metal coated with at least one bioresorbable polymer. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polyethylene terephthalate. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polylactic acid or poly-L-lactic acid. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include poly-glycolic acid or poly-L-glycolic acid. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polycaprolactone. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polyethylene oxide. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polybutylene terephthalate. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polyurethane. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include polycarbonate. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include phospholipid. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include hyaluronic acid. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include fibrin. In certain embodiments, the bioresorbable stent frame structure, the bioresorbabledocking station, or both, include cobalt-chromium. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include titanium. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include tantalum. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include 316L stainless steel. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include platinumchromium. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include platinum-iridium. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include nitinol. In certain embodiments, the bioresorbable stent frame structure, the bioresorbable docking station, or both, include an alloy containing magnesium, iron, silicon, or carbon.

[0069] In certain embodiments, the proximal mounting interlock of the bioresorbable stent frame structure and the distal mounting interlock of the bioresorbable docking station are configured to interlock by piercing and engaging native valve leaflets at the implantation site. In certain embodiments, the transcatheter valve implant assembly is implanted in the patient at the implantation site, and the proximal mounting interlock of the bioresorbable stent frame structure is interlocked with the distal mounting interlock of the bioresorbable docking station.

[0070] In certain embodiments, the inner peripheral surface of the subannular ring of the bioresorbable docking station has an inner mounting interlock, and the distal end of the tubular member of the bioresorbable stent frame structure has a distal mounting interlock. In certain embodiments, the transcatheter valve implant assembly includes a ventricular assist device having a proximal end and a distal end, the ventricular assist device being configured to extend through the tubular member of the bioresorbable stent frame structure and through the subannular ring of the bioresorbable docking station. The distal end of the ventricular assist device has a distal mounting interlock, and the ventricular assist device has an intermediate mounting interlock arranged intermediate of the proximal and distal ends. The distal mounting interlock of the ventricular assist device is configured to releasably connect to the distal mounting interlock of the bioresorbable stent frame structure, and the intermediate mounting interlock of the ventricular assist device is configured releasably connect to the inner mounting interlock of the bioresorbable docking station. In certain embodiments, the transcatheter valve implant assembly is implanted inthe patient at the implantation site, such that the distal mounting interlock of the ventricular assist device is releasably connected to the distal mounting interlock of the bioresorbable stent frame structure and the intermediate mounting interlock of the ventricular assist device is releasably connected to the inner mounting interlock of the bioresorbable docking station. In certain embodiments, the proximal end of the ventricular assist device has an inlet configured to be positioned inferior to the bioresorbable docking station and within a ventricle of the patient, and the distal end of the ventricular assist device has an outlet configured to be positioned within the tubular member of the bioresorbable stent frame structure, such that the ventricular assist device is configured to draw blood at the inlet and discharge blood from the outlet.

[0071] Provided herein is an embodiment of a transcatheter valve implant kit. The transcatheter valve implant kit includes a plurality of bioresorbable docking stations, each bioresorbable docking station of the plurality of bioresorbable docking stations defining a respective subannular ring having a respective outer peripheral surface, a respective inner peripheral surface, and a respective distal axial face. The respective outer peripheral surface of each respective subannular ring has a respective plurality of radial prongs configured to engage tissue of a patient at an implantation site. The respective distal axial face of each respective subannular ring has a respective distal mounting interlock. The transcatheter valve implant kit includes a plurality of bioresorbable stent frame structures, each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures defining a respective tubular member having a respective proximal end and a respective distal end, and a respective prosthetic valve being disposed adjacent to the respective proximal end of each respective tubular member. The respective proximal end of each respective tubular member has a proximal mounting interlock, and the respective proximal mounting interlock of each bioresorbable stent frame structure is configured to interlock with the respective distal mounting interlock of each bioresorbable docking station. Additionally, each bioresorbable docking station of the plurality of bioresorbable docking stations contains a distinct set of one or more bioresorbable materials, and each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures contains a distinct set of one or more bioresorbable materials.

[0072] In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes at least one bioresorbable metal coated with atleast one bioresorbable polymer. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polyethylene terephthalate. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polylactic acid or poly-L-lactic acid. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes poly-glycolic acid or poly-L-gly colic acid. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes poly caprolactone. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polyethylene oxide. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polybutylene terephthalate. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polyurethane. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes polycarbonate. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes phospholipid. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes hyaluronic acid. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbabledocking stations, or both, includes fibrin. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes cobaltchromium. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes titanium. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes tantalum. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes 316L stainless steel. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes platinum-chromium. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes platinum-iridium. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes nitinol. In certain embodiments, at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, includes an alloy containing magnesium, iron, silicon, or carbon.

[0073] In certain embodiments, the respective inner peripheral surface of the respective subannular ring of each bioresorbable docking station of the plurality of bioresorbable docking stations has a respective inner mounting interlock, and the respective distal end of the respective tubular member of each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures has a respective distal mounting interlock. In certain embodiments, the transcatheter valve implant kit includes a ventricular assist device having a proximal end and a distal end, the distal end of the ventricular assist device having a distal mounting interlock, and the ventricular assist device having an intermediate mounting interlock arranged intermediate of the proximal and distal ends.The distal mounting interlock of the ventricular assist device is configured to releasably connect to the respective distal mounting interlock of each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, and the intermediate mounting interlock of the ventricular assist device is configured to releasably connect to the respective inner mounting interlock of each bioresorbable docking station of the plurality of bioresorbable docking stations.

[0074] Further, to the extent consistent, any of the embodiments or aspects described herein may be used in conjunction with any or all of the other embodiments or aspects described herein. While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Any combination of the above embodiments is also envisioned and is within the scope of the appended claims. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope of the claims appended hereto.

Claims

What is claimed is:

1. A transcatheter valve implant assembly comprising: a bioresorbable docking station defining a subannular ring having an outer peripheral surface, an inner peripheral surface, and a distal axial face, the outer peripheral surface of the subannular ring having a plurality of radial prongs configured to engage tissue of a patient at an implantation site, the distal axial face of the subannular ring having a distal mounting interlock; and a bioresorbable stent frame structure defining a tubular member having a proximal end and a distal end, a prosthetic valve being disposed adjacent to the proximal end of the tubular member, the proximal end of the tubular member having a proximal mounting interlock, the proximal mounting interlock of the bioresorbable stent frame structure being configured to interlock with the distal mounting interlock of the bioresorbable docking station.

2. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise at least one bioresorbable metal coated with at least one bioresorbable polymer.

3. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise polyethylene terephthalate.

4. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise polylactic acid or poly-L-lactic acid.

5. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise poly-glycolic acid or poly-L- glycolic acid.

6. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise polycaprolactone.

7. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent framestructure, the bioresorbable docking station, or both, comprise polyethylene oxide.

8. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise polybutylene terephthalate.

9. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise polyurethane.

10. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise polycarbonate.

11. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise phospholipid.

12. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise hyaluronic acid.

13. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise fibrin.

14. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise cobalt-chromium.

15. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise titanium.

16. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise tantalum.

17. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise 316L stainless steel.

18. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise platinum-chromium.

19. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise platinum-iridium.

20. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise nitinol.

21. The transcatheter valve implant assembly of claim 1, wherein the bioresorbable stent frame structure, the bioresorbable docking station, or both, comprise an alloy containing magnesium, iron, silicon, or carbon.

22. The transcatheter valve implant assembly of claim 1, wherein the proximal mounting interlock of the bioresorbable stent frame structure and the distal mounting interlock of the bioresorbable docking station are configured to interlock by piercing and engaging native valve leaflets at the implantation site.

23. The transcatheter valve implant assembly of claim 1, wherein the transcatheter valve implant assembly is implanted in the patient at the implantation site, and wherein the proximal mounting interlock of the bioresorbable stent frame structure is interlocked with the distal mounting interlock of the bioresorbable docking station.

24. The transcatheter valve implant assembly of claim 1, wherein the inner peripheral surface of the subannular ring of the bioresorbable docking station having an inner mounting interlock, and wherein the distal end of the tubular member of the bioresorbable stent frame structure has a distal mounting interlock.

25. The transcatheter valve implant assembly of claim 24, comprising a ventricular assist device having a proximal end and a distal end, the ventricular assist device configured to extend through the tubular member of the bioresorbable stent frame structure and through the subannular ring of the bioresorbable docking station, the distal end of the ventricular assist device having a distal mounting interlock, the ventricular assist device having an intermediate mounting interlock arranged intermediate of the proximal and distal ends, the distal mounting interlock of theventricular assist device being configured to releasably connect to the distal mounting interlock of the bioresorbable stent frame structure and the intermediate mounting interlock of the ventricular assist device configured to releasably connect to the inner mounting interlock of the bioresorbable docking station.

26. The transcatheter valve implant assembly of claim 25, wherein the transcatheter valve implant assembly is implanted in the patient at the implantation site, and wherein the distal mounting interlock of the ventricular assist device is releasably connected to the distal mounting interlock of the bioresorbable stent frame structure and the intermediate mounting interlock of the ventricular assist device is releasably connected to the inner mounting interlock of the bioresorbable docking station.

27. The transcatheter valve implant assembly of claim 25, wherein the proximal end of the ventricular assist device has an inlet configured to be positioned inferior to the bioresorbable docking station and within a ventricle of the patient, and the distal end of the ventricular assist device having an outlet configured to be positioned within the tubular member of the bioresorbable stent frame structure, the ventricular assist device being configured to draw blood at the inlet and discharge blood from the outlet.

28. A transcatheter valve implant kit comprising: a plurality of bioresorbable docking stations, each bioresorbable docking station of the plurality of bioresorbable docking stations defining a respective subannular ring having a respective outer peripheral surface, a respective inner peripheral surface, and a respective distal axial face, the respective outer peripheral surface of each respective subannular ring having a respective plurality of radial prongs configured to engage tissue of a patient at an implantation site, the respective distal axial face of each respective subannular ring having a respective distal mounting interlock; and a plurality of bioresorbable stent frame structures, each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures defining a respective tubular member having a respective proximal end and a respective distal end, a respectiveprosthetic valve being disposed adjacent to the respective proximal end of each respective tubular member, the respective proximal end of each respective tubular member having a proximal mounting interlock, the respective proximal mounting interlock of each bioresorbable stent frame structure being configured to interlock with the respective distal mounting interlock of each bioresorbable docking station, wherein each bioresorbable docking station of the plurality of bioresorbable docking stations contains a distinct set of one or more bioresorbable materials, and each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures contains a distinct set of one or more bioresorbable materials.

29. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises at least one bioresorbable metal coated with at least one bioresorbable polymer.

30. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises polyethylene terephthalate.

31. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises polylactic acid or poly-L-lactic acid.

32. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises poly-glycolic acid or poly-L-glycolic acid.

33. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises polycaprolactone.

34. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises polyethylene oxide.

35. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises polybutylene terephthalate.

36. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises polyurethane.

37. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises polycarbonate.

38. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises phospholipid.

39. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbabledocking station of the plurality of bioresorbable docking stations, or both, comprises hyaluronic acid.

40. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises fibrin.

41. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises cobaltchromium.

42. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises titanium.

43. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises tantalum.

44. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises 316L stainless steel.

45. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises platinumchromium.

46. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises platinumiridium.

47. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises nitinol.

48. The transcatheter valve implant kit of claim 28, wherein at least one bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, or at least one bioresorbable docking station of the plurality of bioresorbable docking stations, or both, comprises an alloy containing magnesium, iron, silicon, or carbon.

49. The transcatheter valve implant kit of claim 28, wherein the respective inner peripheral surface of the respective subannular ring of each bioresorbable docking station of the plurality of bioresorbable docking stations has a respective inner mounting interlock, and wherein the respective distal end of the respective tubular member of each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures has a respective distal mounting interlock.

50. The transcatheter valve implant kit of claim 49, comprising a ventricular assist device having a proximal end and a distal end, the distal end of the ventricular assist device having a distal mounting interlock, the ventricular assist device having an intermediate mounting interlock arranged intermediate of the proximal and distal ends, the distal mounting interlock of the ventricular assist device being configured to releasably connect to the respective distal mounting interlock of each bioresorbable stent frame structure of the plurality of bioresorbable stent frame structures, and the intermediate mounting interlock of the ventricular assist device configured to releasably connect to the respective inner mounting interlock of each bioresorbable docking station of the plurality of bioresorbable docking stations.

1. A transcatheter valve implant assembly comprising: a ventricular assist device, a prosthetic valve, a bioresorbable stent frame structure, and a bioresorbable docking station, the transcatheter valve implant assembly being adapted and configured to be implanted in a patient at an implantation site, the ventricular assist device having a proximal end with an inlet and a distal end with an outlet, the ventricular assist device being adapted and configured to draw blood at the inlet and discharge blood from the outlet, the ventricular assist device having a first mounting interlock on its distal end and a second mounting interlock arranged intermediate of the proximal and distal ends; the bioresorbable docking station having an outer peripheral surface adapted and configured to engage tissue of the patient at the implantation site, the bioresorbable docking station having an inner peripheral surface with an inner surface mounting interlock, the bioresorbable docking station having a distal axial face with a mounting interlock; and the bioresorbable stent frame structure having a proximal end and a distal end, the proximal end of the bioresorbable stent frame structure having a mounting interlock, the distal end of the bioresorbable stent frame structure having a mounting interlock; wherein when the transcatheter valve implant assembly is implanted in a patient at the implantation site: (i) the bioresorbable stent frame structure defines a tubular member with the ventricular assist device positioned within the bioresorbable stent frame structure, (ii) the bioresorbable docking station defines a subannular ring with the outer peripheral surface of the bioresorbable docking station engaged with tissue of the patient at the implantation site, (iii) the inlet of ventricular assist device is positioned in the respective ventricle associated with the implantation site and the outlet of the ventricular assist device is positioned to discharge into a respective blood vessel associated with the implantation site, (iv) the first mounting interlock of the ventricular assist device is releasably connected to the distal end mounting interlock of the bioresorbable stent frame structure; (v) the second mounting interlock of the ventricular assist device is releasably connected to the inner peripheral surfacemounting interlock of the bioresorbable docking station, (vi) the mounting interlock of the proximal end of the bioresorbable stent frame structure is interlocked with the mounting interlock of the distal axial face of the bioresorbable docking station, (vii) the prosthetic valve is disposed adjacent the proximal end of the bioresorbable stent frame structure; and (viii) the prosthetic valve is disposed at least one of adjacent to and against the distal axial face of the bioresorbable docking station.

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