Delivery apparatus and methods for implanting prosthetic devices

Abstract

A delivery apparatus and method for implanting a prosthetic device is disclosed. A delivery apparatus for delivering a prosthetic implant includes a handle and a shaft assembly having an inner shaft and an outer shaft. A cradle member is disposed within a lumen of the handle and is coupled to the outer shaft. An annular groove receiving a sealing member is defined within the cradle member by a proximal end of the outer shaft and a step shoulder formed within the cradle member. The inner shaft extends through a lumen of the outer shaft and includes one or more fluid ports fluidly connecting a lumen of the inner shaft to the lumen of the outer shaft. The implant is coupled to the inner shaft by a frame link having a recess receiving a link tab of the implant. The recess includes an undercut wall that translates tension applied to the link tab into a radial force on the link tab.

Description

[0001] Cross-references to related applications

[0002] This application claims U.S. Provisional Application No. 63 / 154,956, filed March 1, 2021, and U.S. Provisional Application No. 63 / 154,966, filed March 1, 2021. The relevant applications are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to delivery devices and methods for implanting prosthetic devices, and more specifically to delivery devices and methods for implanting support structures and / or prosthetic heart valves. Background Technology

[0004] The human heart can suffer from various valvular diseases. These diseases can lead to serious heart dysfunction, ultimately requiring repair of the original valve or replacement with an artificial valve. Many known repair devices (such as stents) and artificial valves exist, along with numerous known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices into locations within the body that are difficult to access surgically or where access is desired without surgery.

[0005] In one particular example, the prosthetic valve can be mounted in a coiled state on the distal end of a delivery device and advanced through the patient's vascular system (e.g., through the femoral and aortic arteries) until the prosthetic valve reaches its implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies expansion force to the prosthetic valve, or by deploying the prosthetic valve from the sheath of the delivery device, enabling the prosthetic valve to self-expand to its functional size.

[0006] In some cases, such as if the native valve annulus is too large or if the geometry of the native valve is too complex to allow for secure implantation, it may be impossible to secure the prosthetic valve to the native valve annulus. One approach in these cases is to first deploy a docking station at the implantation site and then mount the prosthetic valve within the docking station. The docking station can be selected to provide the necessary interface for anchoring the prosthetic valve within the native valve annulus. Ideally, the docking station can be delivered to the implantation site using a minimally invasive procedure, which would allow the docking station to be deployed within the same procedure used to deliver the prosthetic valve. Summary of the Invention

[0007] Disclosed herein are examples of delivery devices that can be used to deliver a prosthetic implant, such as a docking station, to an implant site within a patient's body. The delivery devices include a handle and a shaft assembly coupled to the handle. The shaft assembly includes an outer shaft and an inner shaft extending through a lumen of the outer shaft. A carriage within the handle is coupled to the outer shaft and is movable relative to the handle to displace the outer shaft axially and relative to the axial handle. Movement of the carriage can displace the outer shaft between an extended position that captures the prosthetic implant and a retracted position that exposes the prosthetic implant. In some examples, the carriage includes a step-down shoulder that forms a gland with a proximal end of the outer shaft. A sealing member can be disposed within the gland to seal between the carriage and the shaft assembly. The step-down shoulder in the carriage allows the carriage to be molded as a single piece, simplifying manufacturing and assembly of the delivery device. In some examples, the inner shaft includes one or more fluid ports that fluidly connect a lumen of the inner shaft to the lumen of the outer shaft, thereby allowing both lumens to be flushed from a single injection port. In some examples, a frame connector is provided that couples an implant device to the inner shaft. The frame connector includes a recess configured to receive a connector tab on the implant device. The recess has at least one undercut wall that translates tension applied to the connector tab into a radial force on the connector tab, which can improve retention characteristics of the prosthetic implant prior to deployment of the prosthetic implant at the implant site and particularly during recapture of the prosthetic implant.

[0008] In one representative example, a delivery device includes a handle body, a carriage member, an outer shaft, an inner shaft, and a sealing member. The handle body has a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, and a cavity disposed between the proximal end and the distal end. The carriage member is disposed within the cavity and is axially movable relative to the handle body in a direction parallel to the longitudinal axis of the handle body. The carriage member has an inner surface defining an internal bore and a gland shoulder integrally formed with the inner surface and defining a step-down transition in the internal bore. The outer shaft includes a proximal end positioned within the internal bore of the carriage member and in opposing relation to the gland shoulder. The proximal end of the outer shaft, the gland shoulder of the carriage member, and a portion of the inner surface of the carriage member adjacent to the step-down transition define an annular groove. The inner shaft extends through a lumen of the outer shaft and is fixed relative to the handle body. The sealing member is disposed about the inner shaft and within the annular groove and is positioned to form a seal between the carriage member and the inner shaft and at the proximal end of the outer shaft.

[0009] In another representative example, a delivery assembly includes the foregoing delivery device and an expandable docking station releasably coupled to the delivery device, wherein the expandable docking station is configured to receive a prosthetic heart valve.

[0010] In another representative example, a method includes inserting a distal end of the foregoing delivery assembly into a vasculature of a patient, advancing the delivery assembly through the vasculature of the patient to position the expandable docking station at a selected implantation site, and moving the cradle member relative to the handle to release the expandable docking station from the delivery device.

[0011] In another representative example, a handle for a prosthetic implant delivery device includes a handle body and a cradle member. The handle body includes a longitudinal axis and a lumen extending along the longitudinal axis. The cradle member is disposed within the lumen and is axially movable relative to the longitudinal axis of the handle body. The cradle member includes a cradle body having an inner surface defining an inner bore and a gland shoulder integrally formed with the inner surface and defining a step-down transition in the inner bore. The gland shoulder and a portion of the inner surface adjacent the step-down transition form a portion of an annular groove configured to receive a sealing member.

[0012] In another representative example, a cradle for a prosthetic implant delivery device includes a single-piece molded body having an inner surface defining an inner bore and a gland shoulder integrally formed with the inner surface and defining a step-down transition in the inner bore. The gland shoulder and a portion of the inner surface adjacent the step-down transition form a portion of an annular groove configured to receive a sealing member.

[0013] In another representative example, a method of forming a component of a prosthetic implant delivery device includes securing a core pin within a mold cavity, and injecting a thermoplastic material into the mold cavity to form a molded body having an inner surface defining an inner bore and a gland shoulder integrally formed with the inner surface and defining a first step-down transition in the inner bore.

[0014] In another representative example, a method of forming a component of a prosthetic implant delivery device includes securing a core pin within a mold cavity, and injecting a thermoplastic material into the mold cavity to form a molded body having an inner surface defining an inner bore, a gland shoulder integrally formed with the inner surface and defining a step-down transition in the inner bore, and a positioning shoulder integrally formed with the inner surface and axially displaced from the gland shoulder.

[0015] In another representative example, a delivery apparatus includes a handle body, an outer shaft, an inner shaft, and an injection port. The handle body includes a longitudinal axis and a lumen extending along the longitudinal axis. The outer shaft includes a proximal end positioned within the lumen. The outer shaft has a first lumen. The inner shaft extends through the first lumen of the outer shaft. The inner shaft has a second lumen and one or more fluid ports fluidly connecting the second lumen to the first lumen. The injection port is fluidly connected to the second lumen of the inner shaft, and both the first lumen and the second lumen are flushable with fluid through the injection port.

[0016] In another representative example, a delivery assembly includes the foregoing delivery apparatus and an expandable docking station for an expandable valve, the expandable docking station releasably coupled to the delivery apparatus.

[0017] In another representative example, a method includes inserting a distal end of the foregoing delivery assembly into a vasculature of a patient, advancing the distal end of the delivery assembly through the vasculature of the patient to position the expandable docking station at a selected implantation site, and moving the cradle member relative to the handle to release the expandable docking station from the delivery apparatus.

[0018] In another representative example, a method includes providing a reinforced tube including an inner layer, a reinforcing layer disposed on the inner layer, and an outer layer disposed on the reinforcing layer. The method includes ablating the reinforced tube at one or more locations to form one or more fluid ports in the reinforced tube.

[0019] In another representative example, a method includes disposing a cover tube having one or more windows on a reinforced tube, and ablating the reinforced tube at one or more locations exposed through the one or more windows to form one or more fluid ports in the reinforced tube.

[0020] In another representative example, a shaft assembly for a prosthetic implant delivery apparatus includes an outer shaft having a first lumen and an inner shaft extending through the first lumen. The inner shaft includes a reinforced tube having a second lumen and one or more fluid ports fluidly connecting the second lumen to the first lumen. The inner shaft further includes a cover tube disposed on the reinforced tube. The cover tube has one or more windows positioned to expose the one or more fluid ports to the first lumen.

[0021] In another representative example, a delivery apparatus includes an elongated shaft and a frame connector. The elongated shaft has a proximal portion and a distal portion. The proximal portion is configured to be disposed outside a patient's body during a delivery procedure and the distal portion is configured to be disposed inside the patient's body during the delivery procedure. The frame connector is coupled to the distal portion of the elongated shaft and is configured for releasably coupling a prosthetic implant to the delivery apparatus. The frame connector includes a connector body having an exterior with an outer surface and a recess. The recess includes a first slot portion having a first width, a second slot portion having a second width that is greater than the first width, and opposing first and second sidewalls extending from a recess floor to the outer surface and connected to the first and second slot portions. At least a first portion of each of the first and second sidewalls connected to the second slot portion includes an undercut from the outer surface to the recess floor.

[0022] In another representative example, a frame connector for a prosthetic implant delivery apparatus includes a connector body having an exterior with an outer surface, a recessed surface, and opposing first and second sidewalls. The recessed surface is spaced radially inward relative to the outer surface and includes a first slot portion having a first width and a second slot portion having a second width that is greater than the first width. The opposing first and second sidewalls extend radially from the recessed surface to the outer surface and are connected to the first and second slot portions. At least a first portion of each of the first and second sidewalls connected to the second slot portion forms an angle within a range of 75-89.9 degrees relative to the recessed surface.

[0023] In another representative example, a delivery assembly includes a self-expandable docking station and a frame connector. The self-expandable docking station includes at least one connector tab having a flared portion. The frame connector includes a connector body having at least one recess that receives and retains the at least one connector tab. The at least one recess includes a slot portion that receives the flared portion, a recess floor, and opposing first and second sidewalls connected to the slot portion and the recess floor. At least a portion of each of the first and second sidewalls forms an angle within a range of 75-89.9 degrees relative to the recess floor.

[0024] Any of the various innovations of the present disclosure can be used alone or in combination with one another. This Abstract is provided to introduce some concepts in a simplified form that are further described below in the Specification. This Abstract is not intended to identify key features of the claimed subject matter, nor is it intended to be used to determine the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the present disclosure will be apparent from the following detailed description, claims, and appended drawings. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 is a front view of a portion of a frame of a docking station in a radially expanded state.

[0026] Figure 2 is a perspective view of a frame of Figure 1 in a radially compressed state.

[0027] Figure 3 is a perspective view of a docking station including Figure 1 a frame of

[0028] Figure 4 is a cross-sectional view of a docking station of Figure 3 deployed at an implant site within patient anatomy schematically depicted in cross-section and with a prosthetic heart valve deployed therein.

[0029] Figure 5A is a perspective view of a delivery apparatus for deploying a docking station.

[0030] Figure 5B illustrates a docking station of Figure 5A disposed about a distal portion of a delivery apparatus of Figure 3

[0031] Figure 6A is a front view of a distal portion of a delivery apparatus of Figure 5A with an outer shaft of the delivery apparatus in a retracted position.

[0032] Figure 6B is a front view of a distal portion of a delivery apparatus of Figure 5A with an outer shaft of the delivery apparatus in an extended position and cut away to illustrate the enclosed docking station.

[0033] Figure 6C-Figure 6F illustrates a stage of deploying a docking station of Figure 5A from a delivery apparatus of Figure 3

[0034] Figure 7A is a perspective view of a handle portion of a delivery apparatus shown in Figure 5A

[0035] Figure 7B and​​​Figure 7C is a perspective view of the handle portion of the Figure 7A , with a portion of the handle sectioned to show various internal components.

[0036] Figure 8A and Figure 8B is a perspective view of the handle portion of the Figure 7A .

[0037] Figure 8C is a perspective view of the handle portion of the Figure 8A and Figure 8B .

[0038] Figure 9 is a perspective view of the handle portion of the Figure 8A and Figure 8B .

[0039] Figure 10 is a perspective view of the handle portion of the Figure 8A and Figure 8B , with a proximal portion of the shaft assembly extending through the cradle member.

[0040] Figure 11A is a cross-sectional view of the handle portion of the Figure 7A , taken along the plane intersecting line 11A-11A as shown in Figure 7A .

[0041] Figure 11B is a cross-sectional view of the handle portion of the Figure 11A , taken along line 11B-11B as shown in Figure 7A .

[0042] Figure 12A is a cross-sectional view of a proximal portion of the shaft assembly coupled to the handle portion of the Figure 7A , with a portion of the shaft assembly sectioned to show a fluid port in an inner shaft of the shaft assembly.

[0043] Figure 12B is a cross-sectional view of a portion of the inner shaft of the shaft assembly as shown in Figure 12A .

[0044] Figure 12C is a magnified view of the area 12C as shown in Figure 12A .

[0045] Figure 13A and Figure 13B are front views of the frame connector.

[0046] Figure 14 is a perspective view of the frame connector of the Figure 13A and Figure 13B , with the sectioning plane taken along line 14-14 as shown in Figure 13A .

[0047] Figure 15 illustrates Figure 13A and Figure 13B frame connectors with the connector tabs of the docking station held in the recesses of the frame connectors.

[0048] Figure 16A is Figure 13A and Figure 13B a perspective view of the frame connectors of Figure 13A taken along line 16A-16A as indicated.

[0049] Figure 16B is Figure 13A and Figure 13B a cross-sectional view of the frame connectors of Figure 16A taken at the section plane indicated.

[0050] Figure 17A is Figure 13A and Figure 13B a perspective view of the frame connectors of Figure 13A taken along line 17A-17A as indicated.

[0051] Figure 17B is Figure 13A and Figure 13B a cross-sectional view of the frame connectors of Figure 17A taken at the section plane indicated.

[0052] Figure 18 is a cross-sectional view of a distal portion of a delivery device illustrating the frame connectors of Figure 5A and Figure 18 connected to the inner shaft of the shaft assembly of Figure 19 and Figure 20 .

[0053] Figure 19 is Figure 5A a front view of a distal portion of a delivery device of Figure 19 where the outer shaft of the delivery device is in an extended position and is cut away to show the docking station constrained by the outer shaft and frame connectors of Figure 20 and .

[0054] Figure 6C-6F is Figure 21 a rotated view of a distal portion of a delivery device of where the frame connectors are cut away to show the engagement with the connector tabs of the docking station.

[0055] ​ illustrates ​ and ​ radial deflection of the connector tabs of the docking station in response to axial tension applied to the connector tabs. DETAILED DESCRIPTION

[0056] General Considerations

[0057] For purposes of this specification, certain specific details are set forth in order to provide a thorough understanding of the disclosed examples. In some instances, the disclosed examples can be practiced without one or more of the specific details, or with other methods, structures, and materials, in some instances, well-known structures and / or processes associated with prosthetic valves and delivery devices have been omitted, such as in order to avoid obscuring the novelty and non-obvious nature of the disclosed examples.

[0058] The disclosed technology is described via examples and embodiments. All examples and embodiments shown herein and described herein can be combined in any number of combinations, unless the context clearly indicates otherwise, such as if a combination would result in an incompatible or an inoperative device. The order of the acts in any process described herein can be re-arranged, unless the context clearly indicates otherwise, such as if an act requires a result of another act as an input.

[0059] For consistency, and for clarity of description, the same or like reference characters can be used in different drawings to designate the same or like elements, and descriptions of elements in one drawing can be deemed to extend to other drawings with the same or like reference characters. In some instances, the term "corresponding to" can be used to describe a correspondence between elements of different drawings. In example usage, when an element in a first drawing is described as corresponding to another element in a second drawing, the element in the first drawing is deemed to have the characteristics of the other element in the second drawing, and vice versa, unless otherwise stated.

[0060] The words "comprise," "comprising," "include," "including," and "includes" and "comprise" are to be construed in an open, inclusive way, i.e., as "including, but not limited to." The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. The term "and / or" as used between the last two items in a list of three or more items means any one of the listed items, or any combination of two or more of the listed items. The term "or" is generally employed in its broadest sense, i.e., as meaning "and / or," unless the context clearly indicates otherwise.

[0061] The term "coupled" without the use of any qualifying language refers generally to physical coupling or linking, and does not exclude the presence of intermediate elements between coupled elements, in the absence of specific contrary language. The terms "a" or "an", or "the" when used in conjunction with a noun, mean one or more of the noun. Directional and other relative references (e.g., inner and outer, upper and lower, above and below, left and right, and proximal and distal) can be used for ease of discussion of the drawings and principles herein, but are not intended to be limiting.

[0062] Introduction to the disclosed technology

[0063] The present disclosure describes a number of delivery devices that can be used to deliver a prosthetic implant, such as a docking station and / or a prosthetic heart valve, to an implantation site within a patient's anatomy. The delivery devices include a shaft assembly coupled to a handle that controls operation of the delivery device. A prosthetic implant can be enclosed within a distal end portion of one of the shafts of the shaft assembly for delivery to the implantation site.

[0064] The shaft assembly includes an outer shaft that is movable between an extended position that encloses a prosthetic implant loaded onto the delivery device and a retracted position that exposes the prosthetic implant for deployment at the implantation site. A carriage member is included in the handle to move the outer shaft between the retracted and extended positions. The shaft assembly includes an inner shaft that extends through a lumen of the outer shaft.

[0065] In certain examples, the carriage member and the outer shaft form a gland or annular groove that retains a sealing member. In certain examples, the inner shaft includes one or more fluid ports that are allowed to flush the inner shaft and the outer shaft with fluid from a single injection port with the sealing member disposed within the carriage member.

[0066] In certain examples, the inner shaft can carry a frame connector having one or more recesses to receive one or more connector tabs of the prosthetic implant and thereby axially constrain the prosthetic implant. In certain examples, the recesses have an undercut wall that converts tension applied to the connector tab into a radial force on the connector tab, which can help maintain engagement of the connector tab with the recess during recompression and / or retrieval of the prosthetic implant.

[0067] Examples of the disclosed technology

[0068] Turning now to the drawings, ​An exemplary embodiment of a frame 100 (or support) that can form the main body of a docking station is illustrated. The frame 100 has a first end 104 and a second end 108. In some examples, the first end 104 may be an inflow end, and the second end 108 may be an outflow end. In other examples, the first end 104 may be an outflow end, and the second end 108 may be an inflow end. The terms "inflow" and "outflow" relate to the normal direction of blood flow (e.g., anterograde blood flow) through the frame. ​ In the unconstrained extended state of the frame 100 shown, the relatively narrower portion (or waist) 112 of the frame 100 between the first end 104 and the second end 108 forms a valve seat 116. The frame 100 can be compressed (e.g., ​ (as shown) so that it can be delivered to the implantation site via a delivery device.

[0069] Although docking stations, delivery devices, prosthetic heart valves and / or methods are described herein with respect to specific implantation sites (e.g., pulmonary valve) and / or specific delivery methods (e.g., transfemoral artery), the devices and methods disclosed herein can be applied to a variety of other implantation sites (e.g., aortic valve, mitral valve and tricuspid valve) and / or delivery methods (e.g., transapical, transseptal, etc.).

[0070] In passing ​ In the example shown, frame 100 includes a plurality of struts 120 arranged to form unit 124. The ends of the struts 120 form apexes 128 at the ends of frame 100. One or more of the apexes 128 may include connecting tabs 132. The portions of the struts 120 between the apexes 128 and the valve seat 116 (or waist 112) form a sealing portion 130 of frame 100. ​ In the unconstrained extended state of the frame 100 shown, the vertex 128 extends approximately radially outward and is radially outside the valve seat 116.

[0071] Frame 100 can be made of highly elastic or compliant materials to accommodate large changes in anatomical structure. For example, frame 100 can be made of flexible metal, metal alloy, polymer, or open-cell foam. An example of a highly elastic metal is nitinol (a metallic alloy of nickel and titanium), but other metals and highly elastic or compliant nonmetallic materials can be used. Frame 100 can be self-expanding, manually expandable (e.g., expandable via a balloon), or mechanically expandable. Self-expanding frames can be made of shape memory materials (e.g., nitinol). In this way, the frame can be as... ​ As shown, it can be radially compressed (e.g., by a coiling device) and can be radially expanded. ​ The structure shown.

[0072] ​An example docking station 136 is illustrated that includes a frame 100 and an impermeable material 140 disposed within the frame. The impermeable material 140 is attached to the frame 100 (e.g., by sutures 144). In the illustrated example, the impermeable material 140 covers at least the cells 124 in the sealing portion 130 of the frame 100. The seal formed by the impermeable material 140 at the sealing portion 130 can help to pool blood flowing into the docking station 136 from the proximal inflow end 104 to the valve seat 116 (and, once a valve is installed in the valve seat, to the valve). One or more rows of cells 124 near the distal outflow end 108 can be open. ​ In the illustrated example, the impermeable material 140 covers at least the cells 124 in the sealing portion 130 of the frame 100. The seal formed by the impermeable material 140 at the sealing portion 130 can help to pool blood flowing into the docking station 136 from the proximal inflow end 104 to the valve seat 116 (and, once a valve is installed in the valve seat, to the valve). One or more rows of cells 124 near the distal outflow end 108 can be open.

[0073] The impermeable material 140 can be a blood-impermeable fabric. Various biocompatible materials can be used as the impermeable material 140, such as a foam or fabric treated with a blood-impermeable coating, a polyester material, or a treated biological material such as pericardium. In one particular example, the impermeable material 140 can be polyethylene terephthalate (PET).

[0074] The docking station 136 can include a band 146 that extends around (or is integral with) the waist 112 of the frame 100. The band 146 can constrain the inflation of the valve seat 116 to a particular diameter in the deployed state to enable the valve seat 116 to support a particular valve size. The band 146 can take various different forms and can be made of various different materials. For example, the band 146 can be made of PET, one or more sutures, a fabric, a metal, a polymer, a biocompatible band, or other relatively non-expanding materials known in the art that can maintain the shape of the valve seat 116.

[0075] ​ An example docking station 136 is illustrated that includes a frame 100 and an impermeable material 140 disposed within the frame. The impermeable material 140 is attached to the frame 100 (e.g., by sutures 144). In the illustrated example, the impermeable material 140 covers at least the cells 124 in the sealing portion 130 of the frame 100. The seal formed by the impermeable material 140 at the sealing portion 130 can help to pool blood flowing into the docking station 136 from the proximal inflow end 104 to the valve seat 116 (and, once a valve is installed in the valve seat, to the valve). One or more rows of cells 124 near the distal outflow end 108 can be open. ​ In the illustrated example, the impermeable material 140 covers at least the cells 124 in the sealing portion 130 of the frame 100. The seal formed by the impermeable material 140 at the sealing portion 130 can help to pool blood flowing into the docking station 136 from the proximal inflow end 104 to the valve seat 116 (and, once a valve is installed in the valve seat, to the valve). One or more rows of cells 124 near the distal outflow end 108 can be open. ​ A prosthetic valve 200 is also shown deployed within the docking station 136 and engaged with the valve seat 116 of the docking station 136. The prosthetic valve 200 can be implanted by first deploying the docking station 136 at an implantation site and then installing the prosthetic valve within the docking station.

[0076] The prosthetic valve 200 can be configured to replace a native heart valve (e.g., an aortic valve, a mitral valve, a pulmonary valve, and / or a tricuspid valve). In one example, the prosthetic valve 200 can include a frame 204 and a valve structure 208 disposed within and attached to the frame 204. The valve structure 208 can include one or more leaflets 212 that cycle between an open state and a closed state during diastole and systole of the heart. The frame 204 can be made from a frame material described with respect to the frame 100 of the docking station 136. The leaflets 212 can be made, in whole or in part, from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials known in the art.

[0077] The docking station 136 is not limited to use with the particular example of the prosthetic valve 200 shown. For example, a mechanically expandable prosthetic valve such as described in U.S. Patent Publication Nos. 2018 / 0153689 and 2019 / 0060057, U.S. Patent Application No. 62 / 869,948, and International Application No. PCT / US2019 / 056865 (the relevant disclosures of which are incorporated by reference herein) can be installed in the docking station 136. ​

[0078] ​ An example delivery apparatus 300 that can be used to deliver the docking station to an implantation location is illustrated. The delivery apparatus 300 generally includes a handle 302 and a shaft assembly 303 that is coupled to and extends distally from the handle 302. The shaft assembly 303 includes an inner shaft 305 and an outer shaft 309. The inner shaft 305 extends through a lumen of the outer shaft 309.

[0079] In the example shown, the frame connector 400 is coupled to the inner shaft 305. The docking station 136 can be disposed about a portion of the inner shaft 305 that extends distally from the frame connector 400, as shown. ​ In one example, the frame connector 400 includes one or more recesses that can receive one or more connector tabs 132 at a proximal end of the docking station 136 and thereby axially constrain the docking station 136. ​ A nosecone 317 can be attached to a distal end of the inner shaft 305. The nosecone 317 includes a central opening 319 for receiving a guidewire. Thus, a proximal end of a guidewire can be inserted into the central opening 319 and through the inner shaft 305, and a distal portion of the delivery apparatus 300 can be advanced over the guidewire through the vasculature of a patient and to an implantation location. The guidewire can pass through the nosecone 317 into the inner shaft 305 during advancement of the delivery apparatus through the vasculature of the patient.

[0080]

[0081] ​​Handle 302 can be manipulated to move outer shaft 309 relative to inner shaft 305 generally between an extended position and a retracted position. Handle 302 can be extended to cause outer shaft 309 to slide over frame link 400 and over any docking station coupled to frame link 400 to encase the docking station within outer shaft 309. As outer shaft 309 slides over docking station 136, outer shaft 309 can compress docking station 136 such that the docking station is encased within outer shaft 309 in a compressed state. In the fully extended position, the distal end of outer shaft 309 can abut the proximal end of nosecone 317 such that there is no gap in the delivery assembly. Additionally (or alternatively), a crimping device can be used to radially compress the docking station such that it can be inserted into the outer shaft of the delivery device.

[0082] ​ A method of deploying a docking station at an implant location within an anatomical structure is illustrated. The patient's anatomy is omitted for illustrative purposes. In ​ the method includes retracting outer shaft 309 through the handle of the delivery device to allow docking station 136 to be loaded onto inner shaft 305. In ​ the method includes disposing docking station 136 around inner shaft 305 and engaging each of the link tabs 132 of docking station 136 with frame link 400. The method further includes positioning outer shaft 309 over docking station such that it is encased therein. This can be accomplished by manipulating the handle of the delivery device. As ​ shown, the distal end of outer shaft 309 abuts the proximal end of nosecone 317. The method includes inserting the delivery device from the nosecone 317 end into the patient's vasculature and advancing the delivery device through the patient's vasculature to the implant location.

[0083] At the implant location, the method includes retracting outer shaft 309 through the handle of the delivery device to expose docking station 136. ​ Different stages of retracting outer shaft 309 are illustrated. It can be seen that in the case where docking station 136 is self-expanding, docking station 136 is gradually uncovered from outer shaft 309 and gradually expands from a compressed state as outer shaft 309 is retracted. When outer shaft 309 is sufficiently retracted, link tabs 132 are disengaged from frame link 400. Once docking station 136 is disengaged from frame link 400, docking station 136 can radially expand to engage the anatomical structure.

[0084] ​An exemplary embodiment of a handle 302 of a delivery device is illustrated. The handle 302 includes a handle body 304 and a deployment mechanism 306 coupled to and partially disposed within the handle body. The handle body 304 includes a proximal end 308, a distal end 312, and a cavity 316 extending from the proximal end 308 to the distal end 312. The handle 302 includes a longitudinal axis 315 extending from the proximal end 308 to the distal end 312. The longitudinal axis 315 defines the axial direction of the handle.

[0085] The handle body 304 may be a single piece having a cavity 316. Alternatively, the handle body 304 may have two body pieces 304a, 304b that can be assembled together to form the cavity 316. For example, the first body piece 304b may have a snap hook 307 that snaps into a complementary recess in the second body piece 304a.

[0086] The deployment mechanism 306 of the handle 302 includes a bracket member 500 and a drive member 320. The bracket member 500 is disposed within a cavity 316 and is movable in the axial direction relative to the handle body 304. The drive member 320 engages with the bracket member 500 and is movable (e.g., rotatable) relative to the handle body 304 to adjust the axial position of the bracket member 500 relative to the handle body 304.

[0087] The proximal portions of shafts 305 and 309 are inserted into the cavity of the handle body 304. The proximal portion of the outer shaft 309 of the shaft assembly 303 may be coupled to the bracket member 500 (e.g., by fasteners, adhesives and / or other means for coupling) such that movement of the bracket member 500 relative to the handle body 304 causes movement of the outer shaft 309 between an extended position and a retracted position.

[0088] The proximal portion of the inner shaft 305 extends through the lumen 313 of the outer shaft 309 into the proximal portion of the cavity 316 and is coupled to the handle body 304. The inner shaft 305 can be fixed relative to the handle body 304 such that the inner shaft 305 remains stationary when the outer shaft 309 moves relative to the handle body 304.

[0089] In passing ​ In the example shown, the injection port 324 is installed at an opening at the proximal end 308 of the handle body 304. The injection port 324 can be, for example, a Luer fitting. The proximal end of the inner shaft 305 can be inserted into the injection port 324. ​ (As shown) and fixed to the injection port 324 (e.g., by coupling). In some cases, the attachment of the inner shaft 305 to the injection port 324 can be used for the purpose of fixing the inner shaft 305 relative to the handle body 304.

[0090] The injection port 324 can be used to inject a flushing fluid (e.g., saline) into the lumen of the inner shaft 305. In some cases, the inner shaft 305 can include one or more fluid ports 311 through which the injected fluid exits the inner shaft 305 and enters the lumen 313 of the outer shaft 309, thereby allowing the lumens of the inner shaft 305 and the outer shaft 309 to be flushed from a single injection port.

[0091] ​ An example embodiment of a carriage member 500 is illustrated. The carriage member 500 includes a carriage body 504 having a distal end 506 and a proximal end 510. The carriage body 504 has a head portion 508 and a stem portion 512 between the distal end 506 and the proximal end 510. The carriage body 504 can be formed (e.g., molded) as a single unitary component. Preferably, the carriage body 504 has sufficient rigidity to support the portion of the shaft assembly received within the handle body 304 (as shown in ​ and 7C ).

[0092] The head portion 508 of the carriage body 504 has an outer surface 516. External threads 518 are formed on portions of the outer surface 516 at opposite sides of the head portion 508. The external threads 518 can engage complementary internal threads in the drive member 320 (as shown in ​ and 7C ) of the handle. The head portion 508 has an inner surface 520 that defines an internal bore 524 configured to receive a portion of the shaft assembly.

[0093] The stem portion 512 includes a central opening 532 that is longitudinally aligned with and connected to the internal bore 524 of the head portion 508, forming a passageway that extends along the entire length of the carriage body 504. Longitudinal slots 536a, 536b (or guide members) are formed on opposite sides of the stem portion 512. The longitudinal slot 536a can be connected to the central opening 532 (or to the passageway formed by the bore 524 and the central opening 532), as shown in ​ . The longitudinal slots 536a, 536b can receive complementary guide members 348a, 348b (as shown in ​ and 11B ) within the elongated cavity of the handle body.

[0094] Referring to ​A positioning shoulder 540 is formed on the inner surface 520 of the head portion 508. The positioning shoulder 540 defines a first stepped transition portion in the bore 524. For example, the positioning shoulder 540 reduces the diameter of the bore 524 from diameter D1 to diameter D2, where diameter D1 is larger than diameter D2. The positioning shoulder 540 is offset by a distance L1 from the distal end 506 of the bracket body 504. The positioning shoulder 540 has an annular surface oriented toward the distal end 506 and may be referred to in some cases as a "distally facing annular shoulder".

[0095] A gland shoulder 544 is formed on the inner surface 520 of the head portion 508. The gland shoulder 544 defines a second-step transition portion in the bore 524. For example, the gland shoulder 544 reduces the diameter of the bore 524 from diameter D2 to diameter D3, where diameter D2 is larger than diameter D3. The gland shoulder 544 is offset from the distal end 506 of the bracket body 504 by a distance L2 greater than L1, meaning that the gland shoulder 544 is located proximal to the positioning shoulder 540. The gland shoulder 544 has an annular surface oriented toward the distal end 506 and may be referred to in some cases as a "distally oriented annular shoulder".

[0096] ​ The shaft assembly 303 extends through a channel formed by a bore 524 and a central opening 532, such that the proximal end (or proximal side) of the outer shaft 309 is positioned within the bore 524. The proximal end of the outer shaft 309 forms a shoulder 546 opposite to and distal to the cap shoulder 544. The outer shaft 309 can be secured in this position to the head portion 508 of the carrier member 500 (e.g., via fasteners, adhesives, and / or other means for coupling). An annular groove 548 (or cap) is defined within the bore 524 by opposing shoulders 544, 546 and the portion of the inner surface 520 between the opposing shoulders 544, 546. The annular groove 548 can receive a sealing member 552.

[0097] In some examples, the locating shoulder 540 can be used as a stop surface at the proximal end of the outer shaft 309. In this case, the diameter D2 corresponding to the inner diameter of the locating shoulder 540 is... ​ (As shown) can be selected to be larger than the inner diameter of the outer shaft 309 at its proximal end, such that when the proximal end of the outer shaft 309 abuts the positioning shoulder 540, a portion of the proximal end of the outer shaft 309 forms a shoulder 546 at the first descending transition portion. For example, as ​ As shown, the shoulder 546 formed by the proximal end of the outer shaft 309 can be located radially inside the positioning shoulder 540 at the first step transition portion.

[0098] In other examples, the carriage body 504 can be formed without the positioning shoulder 540, and the outer shaft 309 can be inserted into the inner bore 524 to a point where a proximal face of the outer shaft 309 abuts a distal face of the sealing member 522 (which will simultaneously form a distal end of the annular groove 548).

[0099] As shown by ​ , the inner shaft 305 extending through the lumen of the outer shaft 309 passes through the portion of the inner bore 524 between the opposing gland shoulders 544, 546, meaning that the annular groove 548 is disposed around the circumference of the inner shaft 305. Thus, a sealing member 552 disposed in the annular groove 548 can form a seal between the inner shaft 305 and the inner surface 520 and at the proximal end of the outer shaft 309. The sealing member 552 can cycle between a dynamic seal and a static seal. The dynamic seal occurs when the sealing member 552 slides along the inner shaft 305 as the carriage member 500 moves relative to the handle body 304 (as shown by ​ and 7C ). In this way, the sealing member 552 can also be referred to as a “wiper seal”. The sealing member 552 can be any suitable seal (e.g., an O-ring).

[0100] The gland shoulder 544 forms a proximal end (or proximal gland shoulder) of the annular groove 548, and the proximal end (or proximal face) of the outer shaft 309 forms a distal end (or distal gland shoulder) of the annular groove 548. In some cases, the positioning shoulder 540 can form a stop for the outer shaft 309. Among other things, forming the shoulder of the carriage body as a stepped shoulder can allow the carriage body 504 (or carriage member 500) to be molded as a single piece. The molding process can include forming a mold cavity and a core pin for the carriage body to form the inner bore including the positioning shoulder 540 and the gland shoulder 544. The core pin is fixed within the mold cavity, and molten thermoplastic material is injected into the mold cavity to form the molded body. The stepped shoulder may, for example, allow the core pin to be easily removed from the distal end of the molded part. Thus, as one example advantage, the disclosed construction simplifies both the manufacture and assembly of the handle.

[0101] Returning to ​ , the carriage member 500 is axially movable within the cavity 316 and relative to the handle body 304 by rotation of the drive member 320. In the example shown by ​ , the drive member 320 has a barrel portion 320a that extends into the cavity 316 from the distal end 312 of the handle body 304 and a knob portion 320b that protrudes from the distal end 312 of the handle body 304. The barrel portion 320a has an annular member 332 that extends into the recess 336 in the handle body 304. A distal face of the annular member 332 can abut a proximal face of the recess 336 to limit movement of the drive member 320 in the distal direction.

[0102] The drive member 320 includes an inner surface 328 that defines an inner bore 340. The inner surface 328 includes internal threads 344 that are complementary to external threads 518 (shown) on a head portion of the carriage member 500. As shown, the carriage member 500 extends into the inner bore 340 such that the external threads 518 on the head portion of the carriage member 500 are engaged with the internal threads 344 in the drive member 320. ​ and 8B As shown, the carriage member 500 extends into the inner bore 340 such that the external threads 518 on the head portion of the carriage member 500 are engaged with the internal threads 344 in the drive member 320.

[0103] Rotation of the knob portion 320b causes rotation of the drive member 320 relative to the handle body 304, which causes the carriage member 500 to move along the inner bore 340 of the drive member 320. The threads 344, 518 translate the rotational motion of the drive member 320 into linear motion of the carriage member 500. However, other mechanisms besides a lead screw mechanism can be used to axially translate the carriage member 500 relative to the handle body 304.

[0104] With reference to ​ and ​ , the handle body 304 can include flat protrusions 348a, 348b (or guide members) that extend into the cavity 316. The flat protrusion 348a is received in a longitudinal slot 536a of the carriage member 500. The flat protrusion 348b is received in a longitudinal slot 536b. As the carriage member 500 is moved axially within the cavity 316 and relative to the handle body 304, the longitudinal slots 536a, 536b move along the respective flat protrusions 348a, 348b. The flat protrusions 348a, 348b are longitudinally aligned with the handle body 304 and cooperate with the longitudinal slots 536a, 536b to prevent rotation of the carriage member 500 as the drive member 320 is rotated.

[0105] ​ A proximal portion of the shaft assembly 303 (i.e., the portion of the shaft assembly 303 that is directly coupled to the handle) is shown. The proximal portion of the shaft assembly 303 includes a proximal portion of the outer shaft 309 and a proximal portion of the inner shaft 305 that extends through the lumen 313 of the outer shaft 309. As previously described with respect to ​ , the proximal end of the outer shaft 309 is received within the carriage member 500 and the inner shaft 305 extends through the outer shaft 309 and through the carriage member. As ​ shown, the proximal portion of the inner shaft 305 includes a proximal end 305a that can be fluidly connected to the injection port 324 (shown in FIGS. 11A and 11B) and a fluid port 311 that allows fluid injected into the inner shaft 305 at the injection port to exit the inner shaft 305 and enter the lumen 313 of the outer shaft 309. ​ ​

[0106] In one embodiment, the inner shaft 305 includes a reinforced tube 321. In the illustrated example, the reinforced tube 321 can include an inner layer 325, a reinforcing layer 329 disposed on the inner layer 325, and an outer layer 333 disposed on the inner layer 325. The inner layer 325, the reinforcing layer 329, and the outer layer 333 can be in the form of a tube that extends substantially along the length of the inner shaft 305. ​

[0107] The reinforced tube 321 can be configured as a flexible tube to facilitate movement of the tube through the vasculature of a patient. The reinforcing layer 329 can be, for example, a braided tube that can be made from a metal wire (e.g., stainless steel wire or nitinol wire) or a synthetic fiber. The inner layer 325 and the outer layer 333 can be tubes made from a polymeric material. Examples of suitable polymeric materials include, but are not limited to, elastomers, nylon, and polyurethane. The inner layer 325 and the outer layer 333 can be made from the same material or different materials. In some cases, the reinforced tube 321 can be made by extrusion.

[0108] The inner shaft 305 can include one or more fluid ports. The fluid ports are formed in the wall of the reinforced tube and can allow flushing fluid to flow from the inner lumen of the inner shaft and into the lumen of the outer shaft 309. In this way, the fluid ports 311 enable flushing of the inner shaft 305 and the outer shaft 309 from a single injection port without the need for separate flushing of the shafts. Referring to ​ and 12C Each fluid port 311 includes a first opening 325a in the inner layer 325, a second opening 333a in the outer layer 333 that is radially aligned with the first opening, and an aperture (or opening) in a portion 329a of the reinforcing layer 329 between the two openings 325a, 333a. The openings 325a, 333a can have any suitable shape (e.g., an elliptical, circular, square, or rectangular shape as illustrated in ​ and 12C ).

[0109] Any number of fluid ports 311 can be formed in the reinforced tube 321. For example, the illustrated reinforced tube 321 includes four ports 311 (as illustrated). Various arrangements of the fluid ports 311 on the reinforced tube 321 are possible when there are multiple fluid ports 311. For example, ​ two fluid ports 311 are illustrated that are axially spaced apart and circumferentially aligned along the reinforced tube 321. As illustrated in ​ the reinforced tube 321 also includes two fluid ports 311 that are axially aligned along the length of the reinforced tube 321. As illustrated in ​ the reinforced tube 321 also includes two fluid ports 311 that are axially aligned along the length of the reinforced tube 321. As illustrated in ​ ​​Two additional fluid ports 311 are shown axially aligned and circumferentially spaced apart (e.g., 180 degrees). In another example, the fluid ports 311 can be spaced apart and / or staggered around the reinforcing tube 321. For example, the fluid ports 311 can be spaced apart and staggered around the reinforcing tube 321 to form a helical pattern. In another example, the fluid ports can form an alternating pattern such that a first side of the tube includes a plurality of ports (e.g., a first proximal port and a first distal port) and a second side of the tube (e.g., positioned 180 degrees from the first side) includes a plurality of ports (e.g., a second proximal port and a second distal port) and the ports are arranged axially in the following manner moving from proximal to distal: first proximal port, second proximal port, first distal port, second distal port.

[0110] In some cases, the inner shaft 305 can include a cover tube 337 extending over a proximal portion of the reinforcing tube 321. The cover tube 337 includes one or more windows 341 positioned to expose the fluid ports 311. The cover tube 337 is a portion of the inner shaft 305 that contacts the seal member 552 (shown) when the inner shaft 305 extends through the cradle member 500 (shown). The cover tube 337 is preferably a rigid member that can support the sliding of the seal member. The cover tube 337 preferably has a surface finish that provides a proper sealing surface to the seal member 552. The cover tube 337 can be made of metal or plastic. For example, the cover tube 337 can be made of stainless steel. The cover tube 337 can be secured to the reinforcing tube 321 by any suitable method, such as by crimping, adhesive, etc. ​ ​ The cover tube 337 is a portion of the inner shaft 305 that contacts the seal member 552 (shown) when the inner shaft 305 extends through the cradle member 500 (shown). The cover tube 337 is preferably a rigid member that can support the sliding of the seal member. The cover tube 337 preferably has a surface finish that provides a proper sealing surface to the seal member 552. The cover tube 337 can be made of metal or plastic. For example, the cover tube 337 can be made of stainless steel. The cover tube 337 can be secured to the reinforcing tube 321 by any suitable method, such as by crimping, adhesive, etc.

[0111] The inner shaft 305 can be formed using any suitable method. One preferred method for forming the inner shaft 305 includes first providing a reinforcing tube 321 without openings formed for the fluid ports. A cover tube 337 having one or more windows 341 formed therein is disposed on the reinforcing tube 321 and secured to the outer layer 333 of the reinforcing tube 321. The fluid ports 311 are then formed in the areas of the reinforcing tube 321 exposed by the window(s) 341 of the cover tube 337.

[0112] In one example, the openings forming each fluid port 311 are formed in the outer layer 333 and the inner layer 325 of the reinforcing tube 321 by laser ablation. Advantageously, the laser beam used in the laser ablation can be configured to remove material only from portions of the outer layer 333 and the inner layer 325 of the reinforcing tube 321, leaving the reinforcing layer 329 intact to maintain the tensile strength of the reinforcing tube 321. Additionally, the laser ablation process removes material by vaporizing the material, thereby reducing or eliminating potential particulate contamination of the delivery device. Any film that settles on the surface of the tube can be rinsed off.

[0113] Referring to ​ ​and ​ For the purpose of flushing the inner shaft, fluid (e.g., saline solution) can be injected into the inner shaft 305 through injection port 324. The fluid will move through the lumen of the inner shaft 305. A portion of the fluid moving through the lumen of the inner shaft 305 will exit through fluid port 311 and enter the lumen 313 of the outer shaft 309, thereby allowing flushing of the outer shaft. Thus, both the inner shaft 305 and the outer shaft 309 can be flushed using a single injection port. Sealing member 552 forms a seal at the proximal end of the outer shaft 309 and prevents fluid leakage from the proximal end of the outer shaft. Later, during use of the delivery device, sealing member 552 will also prevent blood leakage from the proximal end of the outer shaft, thereby maintaining hemostasis.

[0114] Return to ​ The docking station 136 can be configured as a self-expanding docking station, wherein the docking station 136 and the connecting tab 132 are naturally biased toward the expanding configuration. When the docking station 136 is attached to the delivery system, the docking station 136 is compressed into a smaller configuration. ​ (As shown) for insertion and tracking through the vascular system. The compressible construction of the docking station is axially held in place by the frame connector 400 (which is fixed relative to the inner shaft 305) and radially held in place by the outer shaft 309. Thus, premature deployment of the docking station 136 is prevented by the frame connector 400 and the outer shaft 309. Once the docking station 136 is in the implantation position within the anatomical structure, the outer shaft 309 can be retracted to expose and deploy the docking station 136.

[0115] When the outer shaft 309 retracts to expose the docking station 136, the distal portion of the docking station 136 expands (e.g., as...). ​ and ​ (As shown). In some cases, it may be desirable to reposition and / or retrieve the docking station 136 before the outer shaft 309 is fully retracted. In this case, the outer shaft 309 may extend again to recapture and recompress the docking station 136 to allow for repositioning and / or retrieval of the docking station 136. However, the bias toward the extended configuration can create axial tension between the docking station and the frame connector. As the outer shaft extends distally over the docking station for recapture, this axial tension can concentrate at the flange of the connector tabs of the docking station. Due to the relatively high forces during recapture and / or retrieval, the connector tabs of the docking station tend to move radially outward, attempting to disengage from the frame connector 400. This can increase the force required to recapture the docking station. In extreme cases, the connector tabs may disengage from the connector, which can inhibit the recompression and / or retrieval of the docking station.

[0116] ​ An exemplary embodiment of a frame connector 400 is illustrated, which can help retain the connector tabs in a radially compressed configuration during recompression / retrieval at the docking station. Reference​ and 13B As shown in FIG. 4, the frame connector 400 includes a connector body 404, a flange 408 attached to one end of the connector body 404, and a flange 412 attached to the other end of the connector body 404. The flange 408 provides a proximal end 410 of the connector, and the flange 412 provides a distal end 414 of the connector. The frame connector 400 has a longitudinal axis 415 (or central axis) that extends from the proximal end 410 to the distal end 414. The longitudinal axis 415 defines an axial direction of the connector.

[0117] As shown in FIG. 4, the frame connector 400 includes a connector body 404, a flange 408 attached to one end of the connector body 404, and a flange 412 attached to the other end of the connector body 404. The flange 408 provides a proximal end 410 of the connector, and the flange 412 provides a distal end 414 of the connector. The frame connector 400 has a longitudinal axis 415 (or central axis) that extends from the proximal end 410 to the distal end 414. The longitudinal axis 415 defines an axial direction of the connector. ​ As shown in FIG. 4, the frame connector 400 includes a connector body 404, a flange 408 attached to one end of the connector body 404, and a flange 412 attached to the other end of the connector body 404. The flange 408 provides a proximal end 410 of the connector, and the flange 412 provides a distal end 414 of the connector. The frame connector 400 has a longitudinal axis 415 (or central axis) that extends from the proximal end 410 to the distal end 414. The longitudinal axis 415 defines an axial direction of the connector. ​ As shown in FIG. 4, the frame connector 400 includes a connector body 404, a flange 408 attached to one end of the connector body 404, and a flange 412 attached to the other end of the connector body 404. The flange 408 provides a proximal end 410 of the connector, and the flange 412 provides a distal end 414 of the connector. The frame connector 400 has a longitudinal axis 415 (or central axis) that extends from the proximal end 410 to the distal end 414. The longitudinal axis 415 defines an axial direction of the connector.

[0118] Returning to ​ and ​ As shown in FIG. 4, the frame connector 400 includes a connector body 404, a flange 408 attached to one end of the connector body 404, and a flange 412 attached to the other end of the connector body 404. The flange 408 provides a proximal end 410 of the connector, and the flange 412 provides a distal end 414 of the connector. The frame connector 400 has a longitudinal axis 415 (or central axis) that extends from the proximal end 410 to the distal end 414. The longitudinal axis 415 defines an axial direction of the connector. ​ As shown in FIG. 4, the frame connector 400 includes a connector body 404, a flange 408 attached to one end of the connector body 404, and a flange 412 attached to the other end of the connector body 404. The flange 408 provides a proximal end 410 of the connector, and the flange 412 provides a distal end 414 of the connector. The frame connector 400 has a longitudinal axis 415 (or central axis) that extends from the proximal end 410 to the distal end 414. The longitudinal axis 415 defines an axial direction of the connector.

[0119] Still referring to ​ and ​ As shown in FIG. 4, the frame connector 400 includes a connector body 404, a flange 408 attached to one end of the connector body 404, and a flange 412 attached to the other end of the connector body 404. The flange 408 provides a proximal end 410 of the connector, and the flange 412 provides a distal end 414 of the connector. The frame connector 400 has a longitudinal axis 415 (or central axis) that extends from the proximal end 410 to the distal end 414. The longitudinal axis 415 defines an axial direction of the connector. ​As shown, the recess 420 is open at the outer surface 416 such that the connector tab 132 having the flared portion 132a can be positioned in the recess from the outer surface 416.

[0120] Referring to ​ and ​ Each recess 420 has a recess floor 424, opposing side walls 428, 429, and an end wall 430. The side walls 428, 429 protrude from opposite sides of the recess floor 424. The side wall 428 is connected to a portion 417 of the outer surface 416. The side wall 429 is connected to a portion 418 of the outer surface 416. The end wall 430 protrudes from an end of the recess floor 424 and is connected to a portion 419 of the outer surface 416. The recess floor 424 is on a different plane than the surface portions 417, 418, 419. In particular, the recess floor 424 is recessed (or radially inward) relative to the surface portions 417, 418, 419, as more clearly shown in ​ .

[0121] In one example, the surface portions 417, 418 are on the same plane, but on a different plane than the surface portion 419. For example, as shown in ​ , each of the surface portions 417, 418 can be radially outward of the surface portion 419 by an offset distance d. In other words, the height HI of the side walls 428, 429 relative to the recess floor 424 can be greater than the height H2 of the end wall 430 relative to the recess floor 424. Since the connector tab received in the recess 420 will contact the side walls 428, 429, the height of the side walls 428, 429 can be selected to provide sufficient engagement surface for the connector tab.

[0122] A first portion 428a of the side wall 428 and a first portion 429a of the side wall 429 form opposite sides of a first slot portion 420a of the recess 420 (in ​ ). The end wall 430 is longitudinally displaced from the first wall 428 and the second wall 429 by a distance that determines the height of a second slot portion 420b of the recess 420 (in ​ ). A second portion 428b of the side wall 428 and a second portion 429b of the side wall 429 are opposite the end wall 430. The end wall 430 and the second portions 428b, 429b of the side walls 428, 429 form opposite ends of the second slot portion 420b of the recess 420.

[0123] ​ A connector tab 132 of a docking station positioned within a recess 420 of the frame connector 400 prior to deployment of the docking station at an implant location is shown. The connector tab 132 can be formed at an apex of a strut 120 of a frame of the docking station, as previously described. In this example, the docking station is a LCP docking station. The LCP docking station is a LCP docking station as described in U.S. Patent No. 9, 1 1 1, 1 1 1, which is incorporated by reference herein in its entirety. ​In the example shown, the connector tab 132 has a flared portion 132a, which is located in the second slot portion 420b and engages with the sidewalls 428, 429. The flared portion 132a engages with the sidewalls 428, 429 because it is wider than the first slot portion 420a. When the flared portion 132a engages with the sidewalls 428, 429 as shown, it prevents the connector tab 132 from being axially pulled through the first slot portion 420a.

[0124] To help retain the connector tab 132 in a radially compressed configuration and thus its connection to the frame connector 400 when axial tension is generated between the docking station and the frame connector, the second portions 428b, 429b of the sidewalls 428, 429 are formed as undercut walls, meaning that there is a space or recess below each of the second portions 428b, 429b (or a space or recess exists between each of the second portions 428b, 429b and the recessed bottom plate 424). ​ and 17B As shown, the second portions 428b and 429b, formed as undercut walls, are inclined relative to the recessed base plate 424 (i.e., the second portions 428b and 429b are not perpendicular to the recessed base plate 424). The angle α between the second portion 428b and the recessed base plate 424 is less than 90 degrees, and the angle θ between the second portion 429b and the recessed base plate 424 is less than 90 degrees. In some examples, each of angles α and θ can be in the range of 45-89.9 degrees. In other examples, each of angles α and θ can be in the range of 75-89.9 degrees. In a preferred example, each of angles α and θ can be in the range of 81-86 degrees. Angles α and θ can be the same or different.

[0125] When passed ​ and ​ When the frame connector 400 shown is used to axially constrain the docking station 136, the tension generated by the docking station being offset to the extended structure will affect the trumpet-shaped portion of the connector tab. ​ 132a) is axially pulled against the second portions 428b, 429b. The undercut in the second portions 428b, 429b converts a portion of the tension into a radial force that pushes the connecting tabs radially inward toward the central axis of the frame connector 400, thereby improving the retention characteristics of the docking station before deployment. It has been found that each of the angles α, θ between the second portions 428b, 429b and the recessed base plate 424, in the range of 81-86 degrees (in some cases), improves the fixation of the docking station to the delivery system when the outer shaft extends during recapture of the docking station.

[0126] Return to ​ and ​, the first portions 428a, 429a can be formed as undercut walls, meaning that there is a space or recess below each of the first portions 428a, 429a (or between each of the first portions 428a, 429a and the recess floor 424). As shown in ​ , the first portions 428a, 428b as undercut walls are angled with respect to the recess floor 424 (i.e., the first portions 428a, 429b are not perpendicular to the recess floor 424). The angle β between the first portion 428a and the recess floor 424 is less than 90 degrees, and the angle β between the first portion 429a and the recess floor 424 is less than 90 degrees. In some examples, each of the angles β and may be in the range of 45-89.9 degrees. In other examples, each of the angles β and may be in the range of 75-89.9 degrees. In one example, each of the angles β and may be in the range of 81-86 degrees. The angles β and may be the same or can be different. In some examples, the angle β and / or may be the same as the angle a and / or θ. In other examples, the angle β and / or may be different than the angle a and / or θ.

[0127] Returning to ​ , each of the side walls 428, 429 includes a corner where the first slot portion 420a connects to the second slot portion 420b. These corners can be rounded and can have an undercut such that the undercut extends under the entire length of each of the side walls 428, 429. The edges where the side walls 428, 429 intersect the outer surface portions 417, 418 can similarly be rounded.

[0128] Referring to ​ , one preferred method of coupling the frame link 400 to a distal portion of the inner shaft 305 (as shown in ​ ) is through an overmolding process. During the overmolding process, the radial holes 406 in the flanges 408 can receive a stream of injected material. When solidified, the material in the radial holes 406 can anchor the frame link 400 to the inner shaft 305. ​ The inner shaft 305 is shown extending through a lumen of the outer shaft 309. The frame link 400 is dimensioned relative to the outer shaft 309 such that the outer shaft 309 can extend over the frame link 400 and over a docking station disposed distal to the frame link 400 around a portion of the inner shaft 305.

[0129] ​ and ​Portions of the delivery device 300 including the docking station 136 in the compressed configuration are illustrated. The outer shaft 309 is extended to encase the docking station 136. Each of the docking station 136’s connector tabs 132 is disposed in a respective recess 420 of the frame connector 400 and engages with the sidewall of the recess 420. The docking station 136 is held in place axially by the frame connector 400 and radially by the outer shaft 309. It will be appreciated that only a portion of the delivery device is shown in ​ and 20 The remaining portions of the delivery device (e.g., the portions extending to the nosecone, the portions coupled to the handle, the nosecone, and the handle) are visible in ​

[0130] The delivery assembly configured as shown in ​ and ​ may be inserted into a patient’s body and advanced through the patient’s vasculature to an implantation site. At the implantation site, the outer shaft 309 can be retracted to expose the docking station 136 and deploy the docking station as shown in ​ During recapture of the docking station 136, the inner shaft 305 can be under high tensile load while the outer shaft 309 is extended to cover the docking station 136. The undercut in the sidewall of the recess 420 can translate the tension acting on the respective connector tab 132 into a radial force that pushes the connector tab 132 inward toward the central axis of the frame connector 400, as shown in ​ thereby maintaining the connection between the delivery device and the docking station.

[0131] Additional Examples of the Disclosed Technology

[0132] In view of the above-described implementations of the disclosed subject matter, the present application discloses the following additional examples. It should be noted that one feature of an example, taken either alone or in combination with one or more other features of an example, and optionally in combination with one or more features of one or more other examples, is also an example within the disclosure of the present application.

[0133] ​Example 1 : A delivery apparatus comprising a handle body having a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, and a lumen disposed between the proximal end and the distal end; a carrier member disposed within the lumen and axially movable relative to the handle body in a direction parallel to the longitudinal axis of the handle body, the carrier member having an inner surface defining an inner bore, a gland shoulder integrally formed with the inner surface and defining a step-down transition in the inner bore; an outer shaft having a proximal end positioned within the inner bore of the carrier member and in opposing relation to the gland shoulder, wherein the proximal end of the outer shaft, the gland shoulder of the carrier member, and a portion of the inner surface of the carrier member adjacent to the step-down transition define an annular groove; an inner shaft extending through a lumen of the outer shaft and fixed relative to the handle body; and a sealing member disposed about the inner shaft and within the annular groove, wherein the sealing member is positioned between the carrier member and the inner shaft and forms a seal at the proximal end of the outer shaft.

[0134] Example 2: The delivery apparatus of any example herein, particularly example 1, wherein the carrier member further comprises a locating shoulder integrally formed with the inner surface and axially displaced from the gland shoulder, and wherein the proximal end of the outer shaft abuts the locating shoulder of the carrier member to define the annular groove.

[0135] Example 3: The delivery apparatus of any example herein, particularly any of examples 1 and 2, wherein the gland shoulder is an annular shoulder.

[0136] Example 4: The delivery apparatus of any example herein, particularly any of examples 1 to 3, wherein the carrier member is a single piece molded body.

[0137] Example 5: The delivery apparatus of any example herein, particularly any of examples 1 to 4, wherein the outer shaft is coupled to the carrier member and movable by the carrier member relative to the handle body.

[0138] Example 6: The delivery apparatus of any example herein, particularly any of examples 1 to 5, further comprising a first guide member formed in the carrier member; and a second guide member formed in the handle body; wherein the first and second guide members guide axial movement of the carrier member along the longitudinal axis and limit relative rotational movement between the carrier member and the handle body.

[0139] Example 7: The delivery device of any example herein, particularly any of examples 1-5, further comprising opposing first and second longitudinal slots formed in the cradle member; and opposing first and second flat protrusions formed on the handle body; wherein the opposing first and second flat protrusions extend into the opposing first and second longitudinal slots, respectively, to guide axial movement of the cradle member along the longitudinal axis and to prevent relative rotational movement between the cradle member and the handle body.

[0140] Example 8: The delivery device of any example herein, particularly any of examples 1-7, wherein the cradle member comprises a head portion and a stem portion, and wherein the internal bore is formed in the head portion.

[0141] Example 9: The delivery device of any example herein, particularly example 8, wherein the stem portion comprises a central opening connected to the internal bore, and wherein the internal bore and the central opening form a passageway extending along a length of the cradle member.

[0142] Example 10: The delivery device of any example herein, particularly example 9, wherein the head portion comprises an externally threaded surface.

[0143] Example 11: The delivery device of any example herein, particularly example 10, further comprising a drive member rotatably supported within the handle body, the drive member having an internally threaded surface that threadably engages the externally threaded surface of the cradle member; wherein rotation of the drive member relative to the handle body causes the cradle member to move relative to the handle body along the longitudinal axis.

[0144] Example 12: The delivery device of any example herein, particularly example 11, wherein the drive member comprises a barrel portion that is partially received within the cavity of the handle body and a knob portion that is operable to rotate the barrel portion relative to the handle body, and wherein the internally threaded surface is formed in the barrel portion and the knob portion.

[0145] Example 13: The delivery device of any example herein, particularly any of examples 1-12, further comprising an injection port disposed at the proximal end of the handle body, the injection port being fluidly connected to the lumen of the inner shaft.

[0146] Example 14: A delivery assembly comprising a delivery device according to any example herein (particularly any of examples 1-13) and an expandable docking station releasably coupled to the delivery device, wherein the expandable docking station is configured to receive a prosthetic heart valve.

[0147] Example 15: A method comprising inserting a distal end of a delivery assembly according to any example herein (particularly example 14) into a vasculature of a patient; advancing the distal end of the delivery assembly through the vasculature of the patient to position the expandable docking station at a selected implantation site; and moving the cradle member relative to the handle to release the expandable docking station from the delivery device.

[0148] Example 16: The method according to any example herein (particularly example 15), wherein moving the cradle member relative to the handle body to release the expandable docking station from the delivery device comprises moving the cradle member relative to the handle body to retract the outer shaft and expose the expandable docking station.

[0149] Example 17: The method according to any example herein (particularly example 16), further comprising, prior to inserting the distal end of the delivery assembly into the vasculature of the patient, moving the cradle member relative to the handle body to enclose the expandable docking station within the delivery device.

[0150] Example 18: The method according to any example herein (particularly example 17), wherein moving the cradle member relative to the handle body to enclose the expandable docking station within the delivery device comprises moving the cradle member relative to the handle body to extend the outer shaft over the expandable docking station.

[0151] Example 19: A handle for a prosthetic implant delivery device comprising a handle body having a longitudinal axis and a lumen extending along the longitudinal axis; and a cradle member disposed within the lumen and axially movable relative to the longitudinal axis of the handle body, the cradle member comprising a cradle body having an inner surface defining an inner bore, a gland shoulder integrally formed with the inner surface and defining a step-down transition in the inner bore; wherein the gland shoulder and a portion of the inner surface adjacent to the step-down transition form a portion of an annular groove configured to receive a sealing member.

[0152] Example 20: The handle according to any example herein (particularly example 19), wherein the gland shoulder is an annular shoulder.

[0153] Example 21 : The handle of any example herein, including any example as set forth in Example 19 or 20, wherein the carrier body further comprises a locating shoulder integrally formed with the inner surface and axially displaced from the gland shoulder, and wherein the portion of the annular groove is disposed between the gland shoulder and the locating shoulder.

[0154] Example 22: The handle of any example herein, including any of Examples 19-21, wherein the carrier body is a single-piece molded body.

[0155] Example 23: The handle of any example herein, including any of Examples 19-22, further comprising opposing first and second longitudinal slots formed in the carrier body, and opposing first and second flat protrusions formed on the handle body; wherein the opposing first and second flat protrusions extend into the opposing first and second longitudinal slots, respectively, to guide movement of the carrier member along the longitudinal axis of the handle body.

[0156] Example 24: The handle of any example herein, including any of Examples 19-23, wherein the carrier body comprises a head portion and a stem portion, and wherein the internal bore is formed in the head portion.

[0157] Example 25: The handle of any example herein, including Example 24, wherein the stem portion comprises a central opening connected to the internal bore, and wherein the internal bore and the central opening form a passageway extending along a length of the carrier body.

[0158] Example 26: The handle of any example herein, including any of Examples 24 and 25, wherein the head portion comprises an externally threaded surface.

[0159] Example 27: The handle of any example herein, including Example 26, further comprising a drive member rotatably supported within the handle body, the drive member having an internally threaded surface threadably engaged with the externally threaded surface; wherein rotation of the drive member relative to the handle body causes the carrier member to move relative to the handle body along the longitudinal axis.

[0160] Example 28: The handle of any example herein, particularly Example 27, wherein the drive member includes a barrel portion that is partially received within the cavity of the handle body and a knob portion that is operable to rotate the barrel portion relative to the handle body, and wherein the internally threaded surface is formed in the barrel portion and the knob portion.

[0161] Example 29: The handle of any example herein, particularly any of Examples 19-25, further comprising a drive member that is operably coupled to the carrier member to move the carrier member relative to the handle body.

[0162] Example 30: A carrier for a prosthetic implant delivery apparatus comprises a single piece molded body having an inner surface that defines an inner bore, a gland shoulder integrally formed with the inner surface and defining a step-down transition in the inner bore; wherein the gland shoulder and a portion of the inner surface adjacent the step-down transition form a portion of an annular groove configured to receive a sealing member.

[0163] Example 31 : The carrier of any example herein, particularly Example 30, wherein the gland shoulder is an annular shoulder.

[0164] Example 32: The carrier of any example herein, particularly any of Examples 30 and 31, wherein the single piece molded body further comprises a locating shoulder integrally formed with the inner surface and axially displaced from the gland shoulder, and wherein the portion of the annular groove is disposed between the gland shoulder and the locating shoulder.

[0165] Example 33: The carrier of any example herein, particularly any of Examples 30 and 32, wherein the single piece molded body comprises a head portion and a stem portion, and wherein the inner bore is formed in the head portion.

[0166] Example 34: The carrier of any example herein, particularly Example 33, wherein the stem portion includes a central opening that is connected to the inner bore, and wherein the inner bore and the central opening form a channel that extends along a length of the single piece molded body.

[0167] Example 35: The carrier of any example herein, particularly any of Examples 33 and 34, wherein the head portion includes an externally threaded surface.

[0168] Example 36: The carrier of any example described herein, particularly any of examples 34 and 35, further comprising opposing first and second longitudinal slots at least partially formed in the core rod portion and extending parallel to the channel.

[0169] Example 37: The carrier of any example described herein, particularly example 36, wherein at least one of the first and second longitudinal slots is connected to the channel.

[0170] Example 38: A method of forming a component of a prosthetic implant delivery apparatus comprising securing a core pin within a mold cavity; and injecting a thermoplastic material into the mold cavity to form a molded body having an inner surface defining an inner bore, a gland shoulder integrally formed with the inner surface and defining a step-down transition in the inner bore.

[0171] Example 39: A method of forming a component of a prosthetic implant delivery apparatus comprising securing a core pin within a mold cavity; and injecting a thermoplastic material into the mold cavity to form a molded body having an inner surface defining an inner bore, a gland shoulder integrally formed with the inner surface and defining a step-down transition shoulder in the inner bore, and a seating shoulder integrally formed with the inner surface and axially displaced from the gland shoulder.

[0172] Example 40: A delivery apparatus comprising a handle body having a longitudinal axis and a cavity extending along the longitudinal axis; an outer shaft having a proximal end positioned within the cavity, the outer shaft having a first lumen; an inner shaft extending through the first lumen of the outer shaft, the inner shaft having a second lumen and one or more fluid ports fluidly connecting the second lumen to the first lumen; and an injection port fluidly connected to the second lumen of the inner shaft, wherein both the first and second lumens are flushable with fluid through the injection port.

[0173] Example 41 : The delivery apparatus of any example described herein, particularly example 40, wherein the inner shaft comprises a reinforcing tube, and wherein the one or more fluid ports are formed in a wall of the reinforcing tube.

[0174] Example 42: The delivery apparatus of any example described herein, particularly example 41, wherein the reinforcing tube comprises an inner layer, a reinforcing layer disposed on the inner layer, and an outer layer disposed on the reinforcing layer, and wherein the second lumen is formed within the inner layer.

[0175] Example 43: The delivery device of any example herein, in particular example 42, wherein the reinforcement layer comprises a braided material.

[0176] Example 44: The delivery device of any example herein, in particular example 43, wherein each of the fluid ports comprises a first opening in the inner layer, a second opening in the outer layer radially aligned with the first opening, and a portion of the braided tube disposed between the first and second openings.

[0177] Example 45: The delivery device of any example herein, in particular any of examples 41-44, wherein the one or more fluid ports are longitudinally aligned on the reinforcement tube.

[0178] Example 46: The delivery device of any example herein, in particular any of examples 41-44, wherein the one or more fluid ports form a circular pattern around the reinforcement tube.

[0179] Example 47: The delivery device of any example herein, in particular any of examples 41-44, wherein the one or more fluid ports form a helical pattern around the reinforcement tube.

[0180] Example 48: The delivery device of any example herein, in particular any of examples 41-47, further comprising a cover tube disposed over at least a portion of the reinforcement tube, the cover tube having one or more windows positioned to expose the one or more fluid ports.

[0181] Example 49: The delivery device of any example herein, in particular any of examples 40-48, wherein the one or more fluid ports are formed in a portion of the inner shaft proximate the handle body.

[0182] Example 50: The delivery device of any example herein, in particular any of examples 40-49, further comprising a carriage member disposed within the elongate cavity and movable relative to the handle body along the longitudinal axis of the handle body, the carriage member comprising a carriage body having a channel defined therein, wherein the proximal end of the outer shaft is positioned within the channel.

[0183] Example 51: The delivery device of any example herein, in particular example 50, further comprising a sealing member disposed within the channel, wherein the sealing member is positioned to form a seal at the proximal end of the outer shaft.

[0184] Example 52: A delivery assembly comprising a delivery device according to any example herein, particularly any of examples 40-51, and an expandable docking station for an expandable valve, the expandable docking station releasably coupled to the delivery device.

[0185] Example 53: A method comprising inserting a distal end of a delivery assembly according to any example herein, particularly example 52, into a vasculature of a patient; advancing the delivery assembly through the vasculature of the patient to position the expandable docking station at a selected implantation location; and moving the carriage member relative to the handle to release the expandable docking station from the delivery device.

[0186] Example 54: A method comprising providing a reinforced tube comprising an inner layer, a reinforcing layer disposed on the inner layer, and an outer layer disposed on the reinforcing layer; and ablating the reinforced tube at one or more locations to form one or more fluid ports in the reinforced tube.

[0187] Example 55: A method comprising disposing a cover tube having one or more windows over a reinforced tube; and ablating the reinforced tube at one or more locations exposed through the one or more windows to form one or more fluid ports in the reinforced tube.

[0188] Example 56: The method of any example herein, particularly example 55, wherein the reinforced tube comprises an inner layer, a reinforcing layer disposed on the inner layer, and an outer layer disposed on the inner layer, and wherein ablating the reinforced tube comprises ablating the inner layer and the outer layer without ablating the reinforcing layer.

[0189] Example 57: A shaft assembly for a prosthetic implant delivery device comprising an outer shaft having a first lumen and an inner shaft extending through the first lumen. The inner shaft comprises a reinforced tube having a second lumen and one or more fluid ports fluidically connecting the second lumen to the first lumen. The inner shaft further comprises a cover tube disposed over the reinforced tube, the cover tube having one or more windows positioned to expose the one or more fluid ports to the first lumen.

[0190] Example 58: The shaft assembly of any example herein, particularly example 57, wherein the reinforced tube comprises an inner layer, a reinforcing layer disposed on the inner layer, and an outer layer disposed on the reinforcing layer, and wherein the second lumen is formed within the inner layer.

[0191] Example 59: The shaft assembly of any example herein, particularly example 58, wherein the reinforcing layer comprises a braided material.

[0192] Example 60: The shaft assembly of any example herein, particularly any example of example 59, wherein each of the fluid ports comprises a first opening in the inner layer, a second opening in the outer layer radially aligned with the first opening, and a portion of the braided material disposed between the first opening and the second opening.

[0193] Example 61 : A delivery apparatus comprising an elongated shaft having a proximal portion and a distal portion, wherein the proximal portion is configured to be disposed outside a patient’s body during a delivery procedure, and wherein the distal portion is configured to be disposed inside the patient’s body during the delivery procedure; and a frame connector coupled to the distal portion of the elongated shaft and configured for releasably coupling a prosthetic implant to the delivery apparatus, the frame connector comprising a connector body having an outer portion with an outer surface and a recess, the recess comprising a first slot portion having a first width, a second slot portion having a second width greater than the first width, and opposing first and second sidewalls extending from a recess floor to the outer surface and connected to the first and second slot portions, wherein at least a first portion of each of the first and second sidewalls connected to the second slot portion comprises an undercut from the outer surface to the recess floor.

[0194] Example 62: The delivery apparatus of any example herein, particularly example 61, wherein the recess floor is recessed relative to the outer surface of the connector body, and wherein the first and second sidewalls protrude from opposite sides of the recess floor.

[0195] Example 63: The delivery apparatus of any example herein, particularly example 62, wherein the at least first portion of each of the first and second sidewalls of the recess is angled relative to the recess floor of the recess.

[0196] Example 64: The delivery apparatus of any example herein, particularly example 63, wherein the angle is in a range of 75-89.9 degrees.

[0197] Example 65: The delivery apparatus of any example herein, particularly example 63, wherein the angle is in a range of 81-86 degrees.

[0198] Example 66: The delivery apparatus of any example herein, particularly any of examples 62-65, wherein a second portion of each of the first and second sidewalls connected to the first slot portion of the recess comprises an undercut.

[0199] Example 67: The delivery apparatus of any example described herein, in particular any of examples 62-66, wherein the recess comprises an end wall longitudinally displaced from the first and second sidewalls of the recess, and wherein the end wall is connected to the second slot portion.

[0200] Example 68: The delivery apparatus of any example described herein, in particular example 67, wherein a height of each of the first and second sidewalls of the recess relative to the recess floor is greater than a height of the end wall of the recess relative to the recess floor.

[0201] Example 69: The delivery apparatus of any example described herein, in particular any of examples 61-68, wherein each of the first and second sidewalls of the recess comprises a rounded corner where the first and second slot portions of the recess connect.

[0202] Example 70: The delivery apparatus of any example described herein, in particular any of examples 61-69, wherein the recess is one recess of a plurality of recesses, wherein the plurality of recesses are formed in angularly spaced locations on an exterior of the connector body.

[0203] Example 71: The delivery apparatus of any example described herein, in particular any of examples 61-70, wherein the connector body comprises an internal bore, and wherein the elongate shaft extends through the internal bore.

[0204] Example 72: The delivery apparatus of any example described herein, in particular any of examples 61-71, wherein the frame connector comprises a flange formed at an end of the connector body, the flange comprising a plurality of radial holes.

[0205] Example 73: The delivery apparatus of any example described herein, in particular example 72, wherein a portion of the elongate shaft extends over the flange and through the radial holes.

[0206] Example 74: The delivery apparatus of any example described herein, in particular any of examples 61-73, wherein the recess is open at the outer surface.

[0207] Example 75: A frame connector for a prosthetic implant delivery apparatus comprising a connector body having an exterior with an outer surface, a recessed surface spaced radially inward relative to the outer surface, and opposing first and second side walls, the recessed surface comprising a first slot portion having a first width and a second slot portion having a second width greater than the first width, the opposing first and second side walls extending radially from the recessed surface to the outer surface and connecting to the first and second slot portions, wherein at least a first portion of each of the first and second side walls connecting to the second slot portion forms an angle relative to the recessed surface in a range of 75-89.9 degrees.

[0208] Example 76: The frame connector of any example herein, in particular example 75, wherein the angle is in a range of 81-86 degrees.

[0209] Example 77: The frame connector of any example herein, in particular any of examples 75 and 76, wherein a second portion of each of the first and second side walls connecting to the first slot portion forms an angle relative to the recessed surface in a range of 75-89.9 degrees.

[0210] Example 78: The frame connector of any example herein, in particular any of examples 75 to 77, wherein each of the first and second side walls comprises an undercut extending along an entire length of the respective first and second side walls.

[0211] Example 79: The frame connector of any example herein, in particular any of examples 75 to 78, wherein each of the first and second side walls comprises a rounded corner where the first and second slot portions connect.

[0212] Example 80: The frame connector of any example herein, in particular any of examples 75 to 79, wherein the recessed surface is one of a plurality of recessed surfaces formed in angularly spaced locations on the exterior of the connector body.

[0213] Example 81 : The frame connector of any example herein, in particular any of examples 75 to 80, wherein the connector body comprises an internal bore.

[0214] Example 82: The frame connector of any example herein, in particular any of examples 75 to 81, further comprising a flange formed at an end of the connector body, the flange comprising a plurality of radial holes.

[0215] Example 83: A delivery assembly comprising a self-expandable docking station comprising at least one connector tab having a flared portion; and a frame connector comprising a connector body having at least one recess receiving and retaining the at least one connector tab, the at least one recess comprising a slot portion receiving the flared portion, a recess floor, and opposing first and second side walls connected to the slot portion and the recess floor, wherein at least a portion of each of the first and second side walls forms an angle with respect to the recess floor in the range of 75-89.9 degrees.

[0216] Features described herein with respect to any one example can be combined with other features described in any one or more of the other examples, except to the extent otherwise explicitly stated.

[0217] In view of the many possible variations of the principles of the disclosure, it is recognized that the illustrative constructions depicted are by way of example only and should not be considered limiting the scope of the disclosure. Rather, the scope of the claimed subject matter is to be determined only by the following claims and equivalents thereto.

Claims

1. A delivery device, comprising: A handle body having a proximal end, a distal end, a longitudinal axis, and a cavity, the longitudinal axis extending between the proximal end and the distal end, and the cavity disposed between the proximal end and the distal end; A bracket member disposed within the cavity and axially movable relative to the handle body in a direction parallel to the longitudinal axis of the handle body, the bracket member having an inner surface defining an inner bore and a cap shoulder integrally formed with the inner surface and defining a stepped transition portion in the inner bore; An outer shaft having a proximal end positioned within the inner bore of the bracket member and relative to the cap shoulder, wherein the proximal end of the outer shaft, the cap shoulder of the bracket member, and a portion of the inner surface of the bracket member adjacent to the stepped transition define an annular groove. An inner shaft extends through the cavity of the outer shaft and is fixed relative to the handle body; as well as A sealing member disposed around the inner shaft and within the annular groove, wherein the sealing member is positioned between the bracket member and the inner shaft and forms a seal at the proximal end of the outer shaft.

2. The delivery device of claim 1, wherein the carrier component further includes a positioning shoulder integrally formed with the inner surface and axially displaced from the pressure cap shoulder, and wherein the proximal end of the outer shaft abuts the positioning shoulder of the carrier component to define the annular groove.

3. The delivery device according to claim 1 or 2, wherein the capping shoulder is an annular shoulder.

4. The delivery device according to claim 1 or 2, wherein the carrier component is a single-piece molded body.

5. The delivery device according to claim 1 or 2, wherein the outer shaft is coupled to the carrier member and can move relative to the handle body via the carrier member.

6. The delivery device according to claim 1 or 2, further comprising: A first guide member is formed in the bracket member; as well as A second guide member is formed in the handle body. The first guide member and the second guide member guide the axial movement of the bracket member along the longitudinal axis and restrict the relative rotational movement between the bracket member and the handle body.

7. The delivery device according to claim 1 or 2, further comprising: Opposite first longitudinal slots and second longitudinal slots are formed in the bracket member; as well as Opposite first flat protrusions and second flat protrusions are formed on the handle body. The opposing first flat protrusion and the opposing second flat protrusion extend into the opposing first longitudinal slot and the opposing longitudinal slot, respectively, to guide the bracket member to move axially along the longitudinal axis and to prevent relative rotational movement between the bracket member and the handle body.

8. The delivery device according to claim 1 or 2, wherein the carrier member includes a head portion and a core portion, and wherein the inner bore is formed in the head portion.

9. The delivery device of claim 8, wherein the core portion includes a central opening connected to the bore, and wherein the bore and the central opening form a channel extending along the length of the carrier member.

10. The delivery device of claim 9, wherein the head portion includes an externally threaded surface.

11. The delivery device of claim 10, further comprising: A drive member, rotatably supported within the handle body, has an internal threaded surface that threadedly engages with the external threaded surface of the bracket member. The rotation of the drive member relative to the handle body causes the carrier member to move relative to the handle body along the longitudinal axis.

12. The delivery device of claim 11, wherein the drive member comprises a cylindrical portion partially received within the cavity of the handle body and a knob portion operable to rotate the cylindrical portion relative to the handle body, and wherein an internal threaded surface is formed in the cylindrical portion and the knob portion.

13. The delivery device according to claim 1 or 2, further comprising an injection port disposed at the proximal end of the handle body, the injection port being fluidly connected to the lumen of the inner shaft.

14. A delivery component, comprising: The delivery device according to any one of claims 1 to 13; as well as An expandable docking station, releasably coupled to the delivery device, wherein the expandable docking station is configured to receive a prosthetic heart valve.

Images