Delivery device and method for implanting prosthetic devices

Abstract

A delivery device for delivering a prosthetic implant includes a handle and shaft assembly having an inner shaft and an outer shaft. A carriage member is disposed within a cavity of the handle and coupled to the outer shaft. An annular groove for receiving a seal member is defined in the carriage member by a proximal end of the outer shaft and a step-down shoulder formed in the carriage member. The inner shaft extends through a lumen of the outer shaft and includes one or more fluid ports fluidly connecting the lumen of the inner shaft to the lumen of the outer shaft. An implant is coupled to the inner shaft by a frame connector having a recess for receiving a connector tab of the implant. The recess includes an undercut wall that transfers tension applied to the connector tab to a radial force on the connector tab.

Description

Technical Field

[0001] Cross-Reference to Related Applications The present application claims the benefit of U.S. Provisional Patent Application No. 63 / 154,956 filed on March 1, 2021, and U.S. Provisional Patent Application No. 63 / 154,966 filed on March 1, 2021. The related application is incorporated herein by reference.

[0002] Field The present disclosure generally relates to delivery devices and methods for implanting a prosthesis, and more specifically to delivery devices and methods for implanting a support structure and / or a prosthetic heart valve. Background Art

[0003] Background The human heart can be affected by various valve diseases. These valve diseases result in significant cardiac dysfunction, and may eventually require repair of the native valve or replacement of the native valve with a prosthetic valve. There are many known repair devices (e.g., stents) and prosthetic valves, as well as many known methods for implanting these devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver artificial medical devices to internal locations in the body where access by open surgery is not easily achievable, or access without surgery is desirable.

[0004] In one specific example, a prosthetic valve is crimped onto the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the 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 an expansion force to the prosthetic valve, or by deploying the prosthetic valve from the sheath of the delivery device to allow the prosthetic valve to self-expand to its functional size.

[0005] In some cases, securing an artificial valve to the native valve annulus may be impossible, for example, if the native valve annulus is too large or if the geometric shape of the native valve is too complex to allow for secure valve implantation. One approach in these cases is to first deploy a docking station at the implantation site and then install the artificial valve within the docking station. The docking station may be selected to provide the necessary interface for securing the artificial valve within the native valve annulus. Preferably, the docking station can be delivered to the implantation site in a minimally invasive procedure, which allows the docking station to be deployed in the same procedure used to deliver the artificial valve. [Overview of the project]

[0006] overview This specification discloses examples of delivery devices that can be used to deliver artificial implants, such as docking stations, to an implantation site within a patient's body. The delivery device includes a handle and a shaft assembly coupled to the handle. The shaft assembly includes an outer shaft and an inner shaft extending through the lumen of the outer shaft. A carriage within the handle is coupled to the outer shaft and is movable relative to the handle, displacing the outer shaft axially relative to the handle. The movement of the carriage can displace the outer shaft between an expanded position that captures the artificial implant and a retracted position that exposes the artificial implant. In some embodiments, the carriage includes a step-down shoulder that forms a gland together with the proximal end of the outer shaft. A sealing member may be located within the gland to seal between the carriage and the shaft assembly. The step-down shoulder within the carriage allows for the integral molding of the carriage, simplifying both the manufacture and assembly of the delivery device. In some embodiments, the inner shaft includes one or more fluid ports that fluidize the lumen of the inner shaft to the lumen of the outer shaft, allowing both lumenes to be flushed from a single injection port. In some embodiments, a frame connector is provided that connects the implantation device to the inner shaft. The frame connector includes a recess configured to receive a connector tab on the implantation device. The recess has at least one undercut wall, which converts the tension applied to the connector tab into a radial force acting on the connector tab, which can improve the retention characteristics of the artificial implant before deploying the artificial implant at the implantation site and especially during the recapture of the artificial implant.

[0007] In one typical example, the delivery device comprises a handle body, a carriage member, an outer shaft, an inner shaft, and a sealing member. The handle body includes a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends, and a cavity located between the proximal and distal ends. The carriage member is located 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 internal surface defining an internal bore and a ground shoulder integrally formed with the internal surface and defining a step-down transition within the internal bore. The outer shaft includes a proximal end located within the internal bore of the carriage member and facing the ground shoulder. The proximal end of the outer shaft, the ground shoulder of the carriage member, and a portion of the internal surface of the carriage member adjacent to the step-down transition define an annular groove. The inner shaft extends through the lumen of the outer shaft and is fixed to the handle body. The sealing member is positioned around the inner shaft and within the annular groove to form a seal between the carriage member and the inner shaft, and is located at the proximal end of the outer shaft.

[0008] In another representative embodiment, the delivery assembly comprises a preceding delivery device and an expandable docking station releasably coupled to the delivery device, the expandable docking station being configured to receive an artificial heart valve.

[0009] In another representative embodiment, the method includes inserting the distal end of a preceding delivery assembly into the patient's vascular system, advancing the delivery assembly through the patient's vascular system to position an expandable docking station at a selected implantation location, and moving a carriage member relative to a handle to release the expandable docking station from the delivery device.

[0010] In another representative embodiment, a handle for an artificial implant delivery device comprises a handle body and a carriage member. The handle body includes a longitudinal axis and a cavity extending along the longitudinal axis. The carriage member is located within the cavity and is axially movable relative to the longitudinal axis of the handle body. The carriage member comprises a carriage body having an internal surface defining an internal bore and a ground shoulder formed integrally with the internal surface and defining a step-down transition within the internal bore. The ground shoulder and a portion of the internal surface adjacent to the step-down transition form a portion of an annular groove configured to receive a sealing member.

[0011] In another representative embodiment, a carriage for an artificial implant delivery device includes a integrally molded body having an internal surface defining an internal bore and a ground shoulder integrally formed with the internal surface and defining a step-down transition in the internal bore. The ground shoulder and a portion of the internal surface adjacent to the step-down transition form a portion of an annular groove configured to receive a sealing member.

[0012] In another representative embodiment, a method for forming components of an artificial implant delivery device includes fixing a core pin in a mold cavity and injecting a thermoplastic material into the mold cavity to form a molded body having an internal surface defining an internal bore and a ground shoulder formed integrally with the internal surface and defining a first step-down transition within the internal bore.

[0013] In another representative embodiment, a method for forming components of an artificial implant delivery device includes fixing a core pin in a mold cavity and injecting a thermoplastic material into the mold cavity to form a molded body having an internal surface defining an internal bore, a ground shoulder formed integrally with the internal surface and defining a step-down transition within the internal bore, and a positioning shoulder formed integrally with the internal surface and displaced axially from the ground shoulder.

[0014] In another representative embodiment, the delivery device comprises a handle body, an outer shaft, an inner shaft, and an injection port. The handle body includes a longitudinal axis and a cavity extending along the longitudinal axis. The outer shaft includes a proximal end located within the cavity. 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 that fluidize the second lumen to the first lumen. The injection port is fluidize to the second lumen of the inner shaft, and both the first and second lumen are flushable with fluid through the injection port.

[0015] In another typical embodiment, the delivery assembly includes a preceding delivery device and an expandable docking station for an expandable valve that is releasably coupled to the delivery device.

[0016] In another representative embodiment, the method includes inserting the distal end of a preceding delivery assembly into the patient's vascular system, advancing the distal end of the delivery assembly through the patient's vascular system to position an expandable docking station at a selected implantation location, and moving a carriage member relative to a handle to release the expandable docking station from the delivery device.

[0017] In another representative embodiment, the method includes providing a reinforced pipe comprising an inner layer, a reinforcing layer disposed on the inner layer, and an outer layer disposed on the reinforcing layer. The method includes ablation of the reinforced pipe at one or more locations to form one or more fluid ports within the reinforced pipe.

[0018] In another representative embodiment, the method includes placing a cover pipe having one or more windows on top of a reinforced pipe and ablating the reinforced pipe at one or more locations exposed through the one or more windows to form one or more fluid ports within the reinforced pipe.

[0019] In another representative embodiment, a shaft assembly for an artificial implant delivery device comprises 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 that fluidly connect the second lumen to the first lumen. The inner shaft further includes a cover tube positioned on top of the reinforced tube. The cover tube has one or more windows positioned to expose one or more fluid ports to the first lumen.

[0020] In another representative embodiment, the delivery device comprises an elongated shaft and a frame connector. The elongated shaft has a proximal end portion and a distal end portion. The proximal end portion is configured to be positioned outside the patient's body during the delivery procedure, and the distal end portion is configured to be positioned inside the patient's body during the delivery procedure. The frame connector is coupled to the distal end portion of the elongated shaft and is configured to releasely connect the artificial implant to the delivery device. The frame connector comprises a connector body having an external surface and a recess. The recess comprises a first slot portion having a first width, a second slot portion having a second width greater than the first width, a recess floor surface, and opposing first and second side walls extending from the recess floor surface to the external surface and connected to the first and second slot portions. At least the first portion of each of the first and second side walls connected to the second slot portion includes an undercut from the external surface to the recess floor surface.

[0021] In another representative embodiment, a frame connector for an artificial implant delivery device comprises a connector body having an external surface, a recessed surface, and opposing first and second side walls. The recessed surface is spaced radially inward from the external surface and comprises 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 extend radially from the recessed surface to the external surface and are connected to the first and second slot portions. At least the first portion of each of the first and second side walls connected to the second slot portion forms an angle with respect to the recessed surface in the range of 75 to 89.9 degrees.

[0022] In another representative embodiment, the delivery assembly comprises a self-expandable docking station and a frame connector. The self-expandable docking station comprises at least one connector tab having an overhang. The frame connector comprises a connector body having at least one recess for receiving and holding at least one connector tab. The at least one recess comprises an overhang, a recessed floor surface, and a slot portion for receiving opposing first and second side walls connected to the slotted portion and the recessed floor surface. At least one portion of each of the first and second side walls forms an angle with respect to the recessed floor surface in the range of 75 to 89.9 degrees.

[0023] The various innovations of this disclosure may be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form, which will be further described in the detailed description below. This summary is not intended to identify any major or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The aforementioned and other purposes, features and benefits of this disclosure will become more apparent from the detailed description below, the claims, and the accompanying figures. [Brief explanation of the drawing]

[0024] [Figure 1]Figure 1 is an elevational view of a portion of a frame of a docking station in a radially expanded state. [Figure 2] Figure 2 is a perspective view of the frame of Figure 1 in a radially compressed state. [Figure 3] Figure 3 is a perspective view of a docking station including the frame of Figure 1. [Figure 4] Figure 4 is a cutaway view of the docking station of Figure 3 deployed at an implantation site within a patient's anatomy, schematically illustrated in cross-section, with a prosthetic heart valve deployed therein. [Figure 5A] Figure 5A is a perspective view of a delivery device for deploying a docking station. [Figure 5B] Figure 5B shows the docking station of Figure 3 disposed around a distal portion of the delivery device of Figure 5A. [Figure 6A] Figure 6A is an elevational view of a distal portion of the delivery device of Figure 5A, with an outer shaft of the delivery device in a retracted position. [Figure 6B] Figure 6B is an elevational view of a distal portion of the delivery device of Figure 5A, with an outer shaft of the delivery device in an extended position and cut away to show the enclosed docking station. [Figure 6C] Figures 6C-6F illustrate stages of deploying the docking station of Figure 3 from the delivery device of Figure 5A. [Figure 6D] Figures 6C-6F illustrate stages of deploying the docking station of Figure 3 from the delivery device of Figure 5A. [Figure 6E] Figures 6C-6F illustrate stages of deploying the docking station of Figure 3 from the delivery device of Figure 5A. [Figure 6F] Figures 6C-6F illustrate stages of deploying the docking station of Figure 3 from the delivery device of Figure 5A. [Figure 7A] Figure 7A is a perspective view of a handle portion of the delivery device illustrated in Figure 5A. [Figure 7B] Figures 7B and 7C are perspective views of the handle portion of Figure 7A, with a portion of the handle cut away to show various internal components. [Figure 7C] Figures 7B and 7C are perspective views of the handle portion of Figure 7A, with a section of the handle cut out to reveal various internal components. [Figure 8A] Figures 8A and 8B are perspective views of the carriage member of the handle portion shown in Figure 7A. [Figure 8B] Figures 8A and 8B are perspective views of the carriage member of the handle portion shown in Figure 7A. [Figure 8C] Figure 8C is a cross-sectional view of the carriage member shown in Figures 8A and 8B. [Figure 9] Figure 9 is a cross-sectional view of the head portion of the carriage member shown in Figures 8A and 8B. [Figure 10] Figure 10 is a cross-sectional view of the carriage member shown in Figures 8A and 8B, where the proximal portion of the shaft assembly extends through the carriage member. [Figure 11A] Figure 11A is a cross-sectional view of the handle portion of Figure 7A, along the plane that intersects with the line 11A-11A shown in Figure 7A. [Figure 11B] Figure 11B is a cross-sectional view of the handle portion of Figure 7A along the line 11B-11B shown in Figure 11A. [Figure 12A] Figure 12A is a cross-sectional view of the proximal portion of the shaft assembly, where a portion of the shaft assembly has been broken and is connected to the handle portion shown in Figure 7A, revealing the fluid port inside the shaft of the shaft assembly. [Figure 12B] Figure 12B is a cross-sectional view of a portion of the inner shaft of the shaft assembly shown in Figure 12A. [Figure 12C] Figure 12C is an enlarged view of region 12C shown in Figure 12A. [Figure 13A] Figures 13A and 13B are elevation views of the frame connector. [Figure 13B] Figures 13A and 13B are elevation views of the frame connector. [Figure 14] Figure 14 is a perspective view of the frame connector in Figures 13A and 13B, with a fracture section along line 14-14 shown in Figure 13A. [Figure 15]Figure 15 illustrates the frame connectors of Figures 13A and 13B, in which the connector tabs of the docking station are held in the recesses of the frame connectors. [Figure 16A] Figure 16A is a perspective view of the frame connector in Figures 13A and 13B, with a fracture section along line 16A-16A shown in Figure 13A. [Figure 16B] Figure 16B is a cross-sectional view of the frame connectors shown in Figures 13A and 13B at the fracture surface shown in Figure 16A. [Figure 17A] Figure 17A is a perspective view of the frame connector of Figures 13A and 13B, with a fracture section along line 17A-17A shown in Figure 13A. [Figure 17B] Figure 17B is a cross-sectional view of the frame connectors shown in Figures 13A and 13B, at the fracture surface shown in Figure 17A. [Figure 18] Figure 18 is a cross-sectional view of the distal portion of the delivery device, illustrating the frame connectors shown in Figures 13A and 13B, which are connected to the inner shaft of the shaft assembly shown in Figures 5A and 5B. [Figure 19] Figure 19 is an elevation view of the distal portion of the delivery device of Figure 5A, showing the docking station with the outer shaft of the delivery device in the extended position, broken and restrained by the outer shaft, as well as the frame connectors of Figures 13A and 13B. [Figure 20] Figure 20 is a rotational view of the distal portion of the delivery device shown in Figure 19, showing the frame connector broken and engaging with the connector tab of the docking station. [Figure 21] Figure 21 shows the radial deflection of the connector tabs of the docking stations in Figures 19 and 20 in response to the axial force applied to the connector tabs. [Modes for carrying out the invention]

[0025] General Considerations

[0026] For the purposes of this specification, certain specific details are explicitly stated herein in order to provide a complete understanding of the disclosed embodiments. In some cases, as will be recognized by those skilled in the art, the disclosed embodiments may be carried out without one or more of these specific details, or with other methods, structures, and materials not specifically disclosed herein. In some examples, well-known structures and / or processes relating to artificial valves and delivery devices are omitted to avoid obscuring novel and non-obvious aspects of the disclosed embodiments.

[0027] The disclosed technology is described through examples and practices. All examples and practices described herein and shown in the drawings can be combined without limitation to form any number of combinations unless the context expressly indicates otherwise, such as when the proposed combination contains incompatible or mutually exclusive elements. The sequential order of actions in any process described herein may be rearranged, for example, when one action requires the result of another action as input, unless the context expressly indicates otherwise.

[0028] For the sake of brevity and continuity of explanation, the same or similar reference letters may be used for the same or similar elements in different figures, and the description of an element in one figure is considered to carry over when the element appears in another figure with the same or similar reference letters. In some cases, the term "corresponds" may be used to describe correspondences between elements in different figures. In such usage examples, if an element in the first figure is described as corresponding to another element in the second figure, then the element in the first figure is considered to have the characteristics of the other element in the second figure, and vice versa, unless otherwise noted.

[0029] The word "comprise," and its derivatives such as "comprises" and "comprising," should be interpreted in an open, inclusive sense, meaning "including, but not limited to." The singular forms "a," "an," "at least one," and "the" include multiple references unless otherwise indicated by the context. The terms "and / or," when used between the last two elements of a list of elements, mean any one or more of the listed elements. The term "or," unless otherwise explicitly indicated by the context, is generally used in its broadest sense, i.e., as "and / or."

[0030] The term “combined” without modifiers generally means physically joined or linked, and does not exclude the existence of intermediate elements between joined elements unless there is a specific opposite word. The term “plurality” or “multiple” when used with elements means two or more of the elements. Directions and other relative references (e.g., inside and outside, top and bottom, up and down, left and right, and proximal and distal) may be used to facilitate the discussion of the drawings and principles herein, but are not intended to be limiting.

[0031] Overview of the disclosed technologies

[0032] This disclosure describes a number of delivery devices that can be used to deliver docking stations and / or artificial implants, such as artificial heart valves, to implantation sites within the anatomical structures of a patient. The delivery device includes a shaft assembly coupled to a handle, which controls the operation of the delivery device. The artificial implant may be encapsulated within one distal end portion of the shaft of the shaft assembly for delivery to the implantation site.

[0033] The shaft assembly includes an outer shaft that is movable between an expanded position for encapsulating the artificial implant loaded onto the delivery device and a retracted position for exposing the artificial implant to deploy to the implantation position. A carriage member is included as a handle to move the outer shaft between the retracted and expanded positions. The shaft assembly includes an inner shaft that extends through the lumen of the outer shaft.

[0034] In certain embodiments, the carriage member and outer shaft form a gland or annular groove to hold a sealing member. In certain embodiments, the inner shaft includes one or more fluid ports, which, together with a sealing member located within the carriage member, allow the inner and outer shafts to be flushed with fluid from a single injection port.

[0035] In certain embodiments, the inner shaft supports a frame connector having one or more recesses to receive one or more connector tabs of an artificial implant, thereby allowing the artificial implant to be restrained axially. In certain embodiments, the recess has an undercut wall that converts tension applied to the connector tab into a radial force acting on the connector tab, which may help maintain engagement between the connector tab and the recess during recompression and / or retrieval of the artificial implant.

[0036] Examples of the disclosed technology

[0037] Referring here to the drawings, Figure 1 shows an exemplary embodiment of a frame 100 (or stent) that can form the body of a docking station. The frame 100 has a first end 104 and a second end 108. In some embodiments, the first end 104 may be the inlet end and the second end 108 may be the outlet end. In other embodiments, the first end 104 may be the outlet end and the second end 108 may be the inlet end. The terms “inlet” and “outlet” refer to the normal direction of blood flow through the frame (e.g., anterograde blood flow). In the unconstrained expanded state of the frame 100 shown in Figure 1, the relatively narrower portion (or constriction) 112 of the frame 100 between the first end 104 and the second end 108 forms the valve seat 116. The frame 100 can be compressed for delivery to the implantation site by a delivery device (as shown in Figure 2).

[0038] Docking stations, delivery devices, artificial heart valves, and / or methods are described herein with respect to specific implantation sites (e.g., pulmonary valves) and / or specific delivery approaches (e.g., transfemoral), but the devices and methods disclosed herein may be adapted to various other implantation sites (e.g., aortic valves, mitral valves, and tricuspid valves) and / or delivery approaches (e.g., transapical, transseptal).

[0039] In the embodiment illustrated by Figure 1, the frame 100 includes a plurality of struts 120 arranged to form a cell 124. The ends of the struts 120 form vertices 128 at the ends of the frame 100. One or more of the vertices 128 may include a connector tab 132. The portion of the struts 120 between the vertices 128 and the valve seat 116 (or constriction 112) forms a sealing portion 130 of the frame 100. In the unconstrained extended state of the frame 100 as shown in Figure 1, the vertices 128 generally extend radially outward, and radially outward from the valve seat 116.

[0040] The frame 100 can be made from a highly elastic or conforming material to accommodate significant changes in anatomical structure. For example, the frame 100 can be made from a flexible metal, metal alloy, polymer, or open-cell foam. An example of a highly elastic metal is Nitinol, a metal alloy of nickel and titanium, but other metals and highly elastic or conforming non-metallic materials may be used. The frame 100 may be self-expanding, manually expandable (e.g., expandable via a balloon), or mechanically expandable. A self-expanding frame can be made from a shape-memory material such as Nitinol. In this way, the frame can be compressed radially (e.g., via a crimping device) as shown in Figure 2 and expanded radially into the configuration shown in Figure 1.

[0041] Figure 3 shows an exemplary docking station 136, which includes a frame 100 and an impermeable material 140 placed within the frame. The impermeable material 140 is attached to the frame 100 (e.g., by sutures 144). In the embodiment illustrated by Figure 3, the impermeable material 140 covers at least the cells 124 of the sealing portion 130 of the frame 100. The seal formed by the impermeable material 140 in the sealing portion 130 may help to allow blood to flow into the docking station 136 from the proximal inflow end 104 to the valve seat 116 (and the valve, if attached to the valve seat). One or more rows of cells 124 adjacent to the distal outflow end 108 may be left open.

[0042] The impermeable material 140 may be a fabric that is impermeable to blood. Various biocompatible materials can be used as the impermeable material 140, such as foams or fabrics, polyester materials, or treated biological materials (such as pericardium) that have been treated with a blood-impermeable coating. In one particular example, the impermeable material 140 may be polyethylene terephthalate (PET).

[0043] The docking station 136 may include a band 146 that extends around (or is integrated with) the constriction 112 of the frame 100. The band 146 can restrict the expansion of the valve seat 116 to a specific diameter in its expanded state, thereby enabling the valve seat 116 to support a particular valve size. The band 146 can take on a wide variety of different forms and can be made from a wide variety of different materials. For example, the band 146 may be made from PET, one or more sutures, fabric, metal, polymer, biocompatible tape, or other relatively non-expandable materials known in the art that can maintain the shape of the valve seat 116.

[0044] Figure 4 shows the docking station 136 in an expanded state within the self-valving annulus 148. As can be seen, the frame 100 of the docking station 136 is in an expanded state, and the ends of the frame are pressed against the inner surface 152 of the self-valving annulus. The band 146 (shown in Figure 3) can maintain the valve seat 116 at a constant or substantially constant diameter in the expanded state of the frame 100. Figure 4 also shows the artificial valve 200, which is deployed within the docking station 136 and engages with the valve seat 116 of the docking station 136. The artificial valve 200 can be implanted by first deploying the docking station 136 into the implantation position, and then installing the artificial valve within the docking station.

[0045] The prosthetic valve 200 may be configured to replace an autologous heart valve (e.g., the aortic valve, mitral valve, pulmonary valve, and / or tricuspid valve). In one embodiment, the prosthetic valve 200 may include a frame 204 and a valve structure 208 that is located within and attached to the frame 204. The valve structure 208 may include one or more valve leaflets 212 that circulate between open and closed states during the diastole and systole of the heart. The frame 204 may be made from the frame material described for the frame 100 of the docking station 136. The valve leaflets 212 may be made 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.

[0046] The docking station 136 is not limited to use in the specific embodiment of the artificial valve 200 illustrated in Figure 4. For example, mechanically expandable artificial valves, such as those described in U.S. Patent Applications Publication Nos. 2018 / 0153689 and 2019 / 0060057, U.S. Patent Application No. 62 / 869,948, and International Application PCT / US2019 / 056865 (their relevant disclosures are incorporated herein by reference), may be housed within the docking station 136.

[0047] Figure 5A shows an exemplary delivery device 300 that can be used to deliver a docking station to an implantation location. The delivery device 300 generally includes a handle 302 and a shaft assembly 303 coupled to the handle 302 and extending 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 the lumen of the outer shaft 309.

[0048] In the embodiment illustrated by Figure 5A, the frame connector 400 is coupled to the inner shaft 305. The docking station 136 may be positioned around a portion of the inner shaft 305 that extends distally from the frame connector 400, as shown in Figure 5B. In one embodiment, the frame connector 400 includes one or more recesses that receive one or more connector tabs 132 at the proximal end of the docking station 136, thereby allowing the docking station 136 to be restrained axially.

[0049] A nose cone 317 may be attached to the distal end of the inner shaft 305. The nose cone 317 includes a central opening 319 for receiving a guidewire. Thus, the proximal end of the guidewire may be inserted through the inner shaft 305 into the central opening 319, and the distal end portion of the delivery device 300 may be advanced through the patient's vascular system and across the guidewire to the implantation position. The guidewire can pass through the nose cone 317 into the inner shaft 305 during the advancement of the delivery device through the patient's vascular system.

[0050] The handle 302 may generally operate between an extended and retracted position to move the outer shaft 309 relative to the inner shaft 305. The handle 302 may be extended to slide the outer shaft 309 over the frame connector 400 and over any docking station coupled to the frame connector 400, thereby enclosing the docking station within the outer shaft 309. As the outer shaft 309 slides over the docking station 136, the outer shaft 309 may compress the docking station 136 so that the docking station is enclosed in a compressed state within the outer shaft 309. In the fully extended position, the distal end of the outer shaft 309 may abut the proximal end of the nose cone 317 so that there is no gap in the delivery assembly. Additionally (or alternatively), a crimping device may be used to radially compress the docking station so that it can be inserted onto the outer shaft of the delivery device.

[0051] Figures 6A–7D illustrate how to deploy the docking station to the implantation location within an anatomical structure. For illustrative purposes, the patient's anatomical structure is omitted. In Figure 6A, the method includes retracting the outer shaft 309 by the handle of the delivery device to enable loading the docking station 136 onto the inner shaft 305. In Figure 6B, the method includes positioning the docking station 136 around the inner shaft 305 and engaging each of the connector tabs 132 of the docking station 136 with the frame connector 400. The method also includes positioning the outer shaft 309 on the docking station so that the docking station is enclosed therein. This can be achieved by operating the handle of the delivery device. As shown in Figure 6B, the distal end of the outer shaft 309 abuts against the proximal end of the nose cone 317. The method includes inserting the delivery device into the patient's vascular system from the end of the nose cone 317 and advancing the delivery device through the patient's vascular system to the implantation location.

[0052] At the implantation site, the method includes retracting the outer shaft 309 by the handle of the delivery device to expose the docking station 136. Figures 6C–6F show the different stages of retracting the outer shaft 309. As can be seen, when the docking station 136 self-expands, it gradually extends from the outer shaft 309 and gradually expands from a compressed state as the outer shaft 309 is retracted. Once the outer shaft 309 is fully retracted, the connector tab 132 is disengaged from the frame connector 400. Once the docking station 136 is disengaged from the frame connector 400, the docking station 136 can expand radially and engage with the anatomical structure.

[0053] Figures 7A–7C show exemplary embodiments of a delivery device handle 302. The handle 302 includes a handle body 304 and a deployment mechanism 306 coupled to and partially located 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.

[0054] The handle body 304 can be a single molded body having a cavity 316. Alternatively, the handle body 304 may have two body parts 304a and 304b that can be assembled together to form the cavity 316. For example, the first body part 304b may have a snap hook 307 that fits into a complementary recess of the second body part 304a.

[0055] The deployment mechanism 306 of the handle 302 includes a carriage member 500 and a drive member 320. The carriage member 500 is located in the cavity 316 and is axially movable relative to the handle body 304. The drive member 320 engages with the carriage member 500 and is movable (e.g., rotatable) relative to the handle body 304 to adjust the axial position of the carriage member 500 relative to the handle body 304.

[0056] The proximal portions of shafts 305 and 309 are inserted into the cavity of the handle body 304. The proximal end portion of the outer shaft 309 of the shaft assembly 303 can be coupled to the carriage member 500 (e.g., by fasteners, adhesives, and / or other coupling means) such that the movement of the carriage member 500 relative to the handle body 304 causes the movement of the outer shaft 309 between the extended and retracted positions.

[0057] 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 to the handle body 304 so that it remains stationary while the outer shaft 309 moves relative to the handle body 304.

[0058] In the embodiments illustrated by Figures 7A-7C, the injection port 324 is attached to an opening in the proximal end 308 of the handle body 304. The injection port 324 may be, for example, a Luer fitting. The proximal end of the inner shaft 305 can be inserted into the injector port 324 (shown in Figure 11A) and secured to the injection port 324 (for example, by coupling). In some cases, the attachment of the inner shaft 305 to the injection port 324 can serve to secure the inner shaft 305 to the handle body 304.

[0059] The injection port 324 can be used to inject a flushing fluid, such as saline solution, into the lumen of the inner shaft 305. In some cases, the inner shaft 305 may 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 enabling flushing of the lumen of both the inner shaft 305 and the outer shaft 309 from a single injection port.

[0060] Figures 8A-8C show exemplary embodiments of the carriage member 500. 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 may be formed (e.g., molded) as a single, standalone component. Preferably, the carriage body 504 has sufficient rigidity to support a portion of the shaft assembly that will be housed within the handle body 304 (shown in Figures 7B and 7C).

[0061] The head portion 508 of the carriage body 504 has an external surface 516. An external thread 518 is formed on the portion of the external surface 516 that is opposite the head portion 508. The external thread 518 can engage with a complementary internal thread located in the handle drive member 320 (shown in Figures 7B and 7C). The head portion 508 has an internal surface 520 that defines an internal bore 524 configured to receive a portion of the shaft assembly.

[0062] 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 passage that extends along the entire length of the carriage body 504. Longitudinal slots 536a, 536b (or guide members) are formed on the opposing sides of the stem portion 512. The longitudinal slot 536a may be connected to the central opening 532 (or the passage formed by the bore 524 and the central opening 532), as shown in Figure 8C. The longitudinal slots 536a, 536b can receive complementary guide members 348a, 348b (shown in Figures 11A and 11B) located in the elongated cavity of the handle body.

[0063] Referring to Figure 9, the positioning shoulder 540 is formed on the internal surface 520 of the head portion 508. The positioning shoulder 540 defines a first step-down transition in the internal bore 524. For example, the positioning shoulder 540 steps down the diameter of the internal bore 524 from diameter d1 to diameter d2, where diameter d1 is greater than diameter d2. The positioning shoulder 540 is offset by a distance L1 from the distal end 506 of the carriage body 504. The positioning shoulder 540 has an annular surface oriented toward the distal end 506 and may in some cases be called a "distal-facing annular shoulder".

[0064] The ground shoulder 544 is formed on the internal surface 520 of the head portion 508. The ground shoulder 544 defines a second step-down transition in the internal bore 524. For example, the ground shoulder 544 steps down the diameter of the internal bore 524 from diameter d2 to diameter d3, where diameter d2 is greater than diameter d3. The ground shoulder 544 is offset from the distal end 506 of the carriage body 504 by a distance L2 greater than distance L1, meaning that the ground shoulder 544 is located proximal to the positioning shoulder 540. The ground shoulder 544 has an annular surface oriented toward the distal end 506 and may in some cases be called a "distal-facing annular shoulder".

[0065] Figure 10 shows a shaft assembly 303 extending through a passage formed by the internal bore 524 and the central opening 532, such that the proximal end (or proximal face) of the outer shaft 309 is positioned within the internal bore 524. The proximal end of the outer shaft 309 forms a shoulder 546, which is distal to and opposite to the gland shoulder 544. The outer shaft 309 can be fixed in this position (e.g., via fasteners, adhesives, and / or other fastening means) to the head portion 508 of the carriage member 500. The annular groove 548 (or gland) is defined within the internal bore 524 by the opposing shoulders 544, 546 and a portion of the internal surface 520 between the opposing shoulders 544, 546. The annular groove 548 can receive the sealing member 552.

[0066] In some embodiments, the positioning shoulder 540 may act as a stop surface for the proximal end of the outer shaft 309. In this case, the diameter d2 (shown in Figure 9) corresponding to the inner diameter of the positioning shoulder 540 may be selected to be larger than the inner diameter of the outer shaft 309 at the proximal end of the outer shaft 309, such that when the proximal end of the outer shaft 309 contacts the positioning shoulder 540, a portion of the proximal end of the outer shaft 309 forms a shoulder 546 in the first step-down transition. For example, as shown in Figure 10, the shoulder 546 formed by the proximal end of the outer shaft 309 may be radially inward of the positioning shoulder 540 in the first step-down transition.

[0067] In other embodiments, the carriage body 504 may be formed without the positioning shoulder 540, and the outer shaft 309 may be inserted into the internal bore 524 until the proximal surface of the outer shaft 309 abuts against the distal surface of the sealing member 522, which simultaneously forms the distal end of the annular groove 548.

[0068] As shown in Figure 10, the inner shaft 305, extending through the lumen of the outer shaft 309, passes through a portion of the internal bore 524 between opposing ground shoulders 544, 546, which means that the annular groove 548 is positioned around the inner shaft 305. Thus, the sealing member 552 positioned within the annular groove 548 can form a seal between the inner shaft 305 and the internal surface 520 at the proximal end of the outer shaft 309. The sealing member 552 can circulate between dynamic sealing and static sealing. Dynamic sealing occurs as the carriage member 500 moves relative to the handle body 304 when the sealing member 552 slides along the inner shaft 305 (shown in Figures 7B and 7C). In this way, the sealing member 552 may also be called a “wiper seal”. The sealing member 552 can be any suitable seal (e.g., an O-ring).

[0069] The ground shoulder 544 forms the proximal end (or proximal ground shoulder) of the annular groove 548, and the proximal end (or proximal face) of the outer shaft 309 forms the distal end (or distal ground shoulder) of the annular groove 548. In some cases, the positioning shoulder 540 may form a stop for the outer shaft 309. Forming the shoulder of the carriage body as a stepped shoulder can, among other things, enable the integral molding of the carriage body 504 (or carriage member 500). The molding process may include forming mold cavities for the carriage body and core pin to form an internal bore including the positioning shoulder and ground shoulders 540, 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 can, for example, allow the core pin to be easily removed from the distal end of the molded part. Thus, the disclosed configuration simplifies both the manufacture and assembly of the handle, as one exemplary advantage.

[0070] Returning to Figure 7C, the carriage member 500 is movable axially relative to the handle body 304 within the cavity 316 by the rotation of the drive member 320. In the embodiment shown in Figure 11A, the drive member 320 has a barrel portion 320a extending into the cavity 316 from the distal end 312 of the handle body 304 and a knob portion 320b protruding from the distal end 312 of the handle body 304. The barrel portion 320a has a ring member 332 extending into the recess 336 of the handle body 304. The distal surface of the ring member 332 abuts against the proximal surface of the recess 336, thereby restricting the distal movement of the drive member 320.

[0071] The drive member 320 includes an internal surface 328 that defines an internal bore 340. The internal surface 328 includes an internal thread 344 that is complementary to the external thread 518 (shown in Figures 8A and 8B) on the head portion of the carriage member 500. As shown, the carriage member 500 extends into the internal bore 340 such that the external thread 518 on the head portion of the carriage member 500 engages with the internal thread 344 of the drive member 320.

[0072] The rotation of the knob portion 320b causes the drive member 320 to rotate relative to the handle body 304, which moves the carriage member 500 along the internal bore 340 of the drive member 320. The threads 344 and 518 convert the rotational motion of the drive member 320 into the linear motion of the carriage member 500. However, other mechanisms besides the lead screw mechanism can be used to move the carriage member 500 axially relative to the handle body 304 in translation.

[0073] Referring to Figures 11A and 11B, the handle body 304 may include flattened projections 348a, 348b (or guide members) extending into the cavity 316. Flattened projection 348a is received in a longitudinal slot 536a of the carriage member 500. Flattened projection 348b is received in a longitudinal slot 536b. The longitudinal slots 536a, 536b move along their respective flattened projections 348a, 348b as the carriage member 500 moves axially relative to the handle body 304 within the cavity 316. The flattened projections 348a, 348b are longitudinally aligned with the handle body 304 and work in cooperation with the longitudinal slots 536a, 536b to prevent rotation of the carriage member 500 when the drive member 320 rotates.

[0074] Figure 12A shows the proximal portion of the shaft assembly 303 (i.e., the portion of the shaft assembly 303 immediately coupled to the handle). The proximal portion of the shaft assembly 303 includes the proximal portion of the outer shaft 309 and the proximal portion of the inner shaft 305 extending through the lumen 313 of the outer shaft 309. As previously described in relation to Figure 11A, 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 in Figure 12A, the proximal end portion of the inner shaft 305 includes a proximal end 305a which can be fluid-connected to an injection port 324 (shown in Figures 7A-7C and 11A), and a fluid port 311 which 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.

[0075] In one embodiment, the inner shaft 305 includes a reinforced tube 321. In the embodiment illustrated by Figure 12B, the reinforced tube 321 may include an inner layer 325, a reinforcing layer 329 positioned on top of the inner layer 325, and an outer layer 333 positioned on top of the reinforcing layer 329. The inner layer 325, the reinforcing layer 329, and the outer layer 333 may be in the form of a tube that extends substantially along the length of the inner shaft 305.

[0076] The reinforced tube 321 may be configured as a flexible tube to facilitate the movement of the tube through the patient's vascular system. The reinforcing layer 329 may be a braided tube made from, for example, metal wire (such as stainless steel wire or nitinol wire) or synthetic fiber. The inner layer 325 and outer layer 333 may be tubes made of polymer material. Examples of suitable polymer materials include, but are not limited to, PEBAX® elastomer, nylon, and polyurethane. The inner layer 325 and outer layer 333 may be made of the same material or different materials. In some cases, the reinforced tube 321 may be made by extrusion molding.

[0077] The inner shaft 305 may include one or more fluid ports. The fluid ports are formed in the reinforced tube walls and can allow flushing fluid to flow from the inner lumen of the inner shaft into the lumen of the outer shaft 309. In this way, the fluid port 311 allows flushing of the inner shaft 305 and the outer shaft 309 from a single injection port, instead of requiring the shafts to be flushed separately. Referring to Figures 12B 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 radially aligned with the first opening, and a pore (or opening) of a portion 329a of the reinforcement layer 329 between the two openings 325a, 333a. The openings 325a, 333a may have any suitable shape (e.g., oval, circular, square, or rectangular as shown in Figures 12A and 12C).

[0078] Any number of fluid ports 311 can be formed within the reinforced pipe 321. For example, the illustrated reinforced pipe 321 has four ports 311 (shown in Figure 12B). When there are multiple fluid ports 311, various arrangements of the fluid ports 311 on the reinforced pipe 321 are possible. For example, Figures 12A-12C show two fluid ports 311 spaced apart axially and aligned circumferentially along the reinforced pipe 321. As shown in Figure 12B, the reinforced pipe 321 also has two additional fluid ports 311 aligned axially and spaced circumferentially from the fluid ports shown in Figure 12C (e.g., only 180 degrees). In another embodiment, the fluid ports 311 can be spaced apart and / or staggered around the reinforced pipe 321. For example, the fluid ports 311 can be spaced apart and staggered around the reinforced pipe 321 to form a helical pattern. In another embodiment, the fluid ports may form an alternating pattern such that a first side of the tube has a plurality of ports (e.g., a first proximal port and a first distal port), and a second side of the tube (e.g., located 180 degrees from the first side) has a plurality of ports (e.g., a second proximal port and a second distal port), and the ports are arranged axially in a manner that they move from proximal to distal, in the order of the first proximal port, the second proximal port, the first distal port, and the second distal port.

[0079] In some examples, the inner shaft 305 may include a cover tube 337 extending over the proximal portion of the reinforced tube 321. The cover tube 337 includes one or more windows 341 positioned to expose the fluid port 311. The cover tube 337 is a portion of the inner shaft 305 that contacts the seal member 552 (shown in Figure 11A) as the inner shaft 305 extends through the carriage member 500 (shown in Figure 11A). The cover tube 337 is preferably a rigid member capable of supporting the sliding of the seal member. The cover tube 337 is preferably having a surface finish that provides a suitable sealing surface for the seal member 552. The cover tube 337 may be made of metal or plastic. For example, the cover tube 337 may be made of stainless steel. The cover tube 337 may be fixed to the reinforced tube 321 by any suitable method, such as crimping or adhesive.

[0080] The inner shaft 305 can be formed using any suitable method. One preferred method for forming the inner shaft 305 involves first providing a reinforced tube 321 without openings for forming fluid ports. A cover tube 337 having one or more windows 341 formed therein is placed on top of the reinforced tube 321 and fixed to the outer layer 333 of the reinforced tube 321. The fluid ports 311 are then formed in the region of the reinforced tube 321 exposed through the windows 341 of the cover tube 337.

[0081] In one embodiment, the openings forming each fluid port 311 are formed in the outer layer 333 and inner layer 325 of the reinforced tube 321 by laser ablation. Advantageously, the laser beam used in the laser ablation may be configured to remove material from only portions of the outer layer 333 and inner layer 325 of the reinforced tube 321, leaving the reinforcing layer 329 intact to maintain the tensile strength of the reinforced tube 321. Furthermore, the laser ablation process removes material by evaporation, thereby reducing or eliminating potential particulate contamination of the delivery device. Any film that adheres to the surface of the tube may be washed away.

[0082] Referring to Figures 11A and 12A, a fluid (e.g., saline solution) can be injected into the inner shaft 305 through the injection port 324 for the purpose of flushing the inner shaft. The fluid will then move through the lumen of the inner shaft 305. A portion of the fluid moving through the lumen of the inner shaft 305 exits through the fluid port 311 and enters the lumen 313 of the outer shaft 309, enabling flushing of the outer shaft. Thus, both the inner shaft 305 and the outer shaft 309 can be flushed using a single injection port. The sealing member 552 forms a seal at the proximal end of the outer shaft 309, preventing leakage of fluid from the proximal end of the outer shaft. Subsequently, during use of the delivery device, the sealing member 552 also prevents leakage of blood from the proximal end of the outer shaft, thereby maintaining hemostasis.

[0083] Returning to Figures 6A-6F, the docking station 136 can be configured as a self-expanding docking station, where the docking station 136 and connector tab 132 are naturally biased toward an expanded configuration. While the docking station 136 is attached to the delivery system, it compresses to a smaller configuration (shown in Figure 6B) for insertion and tracking through the vascular system. The compressed configuration of the docking station is held in place axially by the frame connector 400 (fixed to the inner shaft 305) and radially by the outer shaft 309. Thus, the frame connector 400 and the outer shaft 309 prevent the docking station 136 from deploying prematurely. Once the docking station 136 is in its implantation position within the anatomical structure, the outer shaft 309 can be retracted to expose and deploy the docking station 136.

[0084] As the outer shaft 309 is retracted to expose the docking station 136, the distal portion of the docking station 136 expands (for example, as shown in Figures 6C and 6D). In some cases, it may be desirable to reposition and / or retrieve the docking station 136 before the retraction of the outer shaft 309 is complete. In this case, the outer shaft 309 may expand again to recapture and recompress the docking station 136, allowing the docking station 136 to be repositioned and / or retrieved. However, the bias toward the expanded configuration can generate an axial force between the docking station and the frame connector. The axial force may concentrate on the flange of the connector tab of the docking station as the outer shaft is distally extended over the docking station for recapture. Due to the relatively high force during recapture and / or retrieval, the connector tab of the docking station tends to move radially outward while attempting to disengage from the frame connector 400. This can increase the force required to recapture the docking station. In extreme cases, the connector tab may become disengaged from the connector, which could prevent the docking station from being recompressed and / or retrieved.

[0085] Figures 13A–17B show exemplary implementations of a frame connector 400 that can help retain the connector tabs in a radially compressed configuration during recompression / retrieval of a docking station. Referring to Figures 13A and 13B, 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 the proximal end 410 of the connector, and the flange 412 provides the distal end 414 of the connector. The frame connector 400 has a longitudinal axis 415 (or central axis) extending from the proximal end 410 to the distal end 414. The longitudinal axis 415 defines the axial direction of the connector.

[0086] As shown in Figure 14, the frame connector 400 has an internal bore 413 extending along the longitudinal axis (415 in Figure 13B) through flanges 408, 412 and the connector body 404. The internal bore 413 can receive the proximal portion of the inner shaft of the shaft assembly of the delivery device. The flange 408 may include a radial hole 406 that connects to the internal bore 413. As will be discussed later, the radial hole 406 may play a role when the frame connector 400 is fixed to the inner shaft of the shaft assembly (e.g., by an overmolding process).

[0087] Returning to Figures 13A and 13B, the connector body 404 includes an exterior having an outer surface 416 and one or more recesses 420. Each of the recesses 420 can receive one of the connector tabs of a docking station. In the embodiments illustrated by Figures 13A–17B, two recesses 420 are formed on the exterior of the connector body 404 at opposite positions. Generally, when multiple recesses 420 are formed on the exterior of the connector body 404, the recesses 420 may be formed at angular (or "circumferentially") spacing positions along the exterior of the connector body 404 (i.e., distributed along the periphery of the connector body 404).

[0088] Referring further to Figures 13A and 13B, each recess 420 may be a recessed slot having a first slot portion 420a and a second slot portion 420b arranged to form a "T" shape. As shown, the first slot portion 420a is generally aligned with the longitudinal axis 415 of the connector and generally perpendicular to the second slot portion 420b. The first slot portion 420a has a first width W1, and the second slot portion 420b has a second width W2. The second width W2 is greater than the first width W1, which means that the recess 420 transitions from a wider slot portion 420b to a narrower slot portion 420a. As shown in Figure 15, the recess 420 is open on the outer surface 416 so that a connector tab 132 having a protruding portion 132a can be positioned within the recess away from the outer surface 416.

[0089] Referring to Figures 13A and 16A, each recess 420 has a recessed floor surface 424, opposing side walls 428, 429, and an end wall 430. The side walls 428, 429 project from the opposing sides of the recessed floor surface 424. Side wall 428 connects to a portion 417 of the outer surface 416. Side wall 429 connects to a portion 418 of the outer surface 416. The end wall 430 projects from the end of the recessed floor surface 424 and connects to a portion 419 of the outer surface 416. The recessed floor surface 424 is on a different plane compared to the surface portions 417, 418, 419. In particular, the recessed floor surface 424 is recessed (or radially inward) relative to the surface portions 417, 418, 419, as is more clearly shown in Figure 16A.

[0090] In one embodiment, surface portions 417 and 418 are on the same plane but on different planes compared to surface portion 419. For example, as shown in Figure 13B, each of surface portions 417 and 418 may be radially outward of surface portion 419 by an offset distance d. In other words, the height h1 of the side walls 428 and 429 relative to the recess floor surface 424 may be greater than the height h2 of the end wall 430 relative to the recess floor surface 424. Since the connector tab to be received in the recess 420 will contact the side walls 428 and 429, the heights of the side walls 428 and 429 may be selected to provide a sufficient engagement surface for the connector tab.

[0091] The first portion 428a of side wall 428 and the first portion 429a of side wall 429 form the opposing sides of the first slot portion 420a (Figure 13A) of recess 420. The end wall 430 is displaced longitudinally from the first and second walls 428 and 429 by a distance that determines the height of the second slot portion 420b (Figure 13A) of recess 420. The second portion 428b of side wall 428 and the second portion 429b of side wall 429 are in a relationship opposite to the end wall 430. The end wall 430, and the second portions 428b and 429b of side walls 428 and 429, form the opposing ends of the second slot portion 420b of recess 420.

[0092] Figure 15 shows the connector tab 132 of the docking station positioned within the recess 420 of the frame connector 400 before the docking station is deployed to its embedded position. The connector tab 132 may be formed at the apex of the support column 120 of the frame of the docking station, as previously described. In the embodiment illustrated by Figure 15, the connector tab 132 has a protruding portion 132a that fits into the second slot portion 420b and engages with the side walls 428, 429. The protruding portion 132a engages with the side walls 428, 429 because the protruding portion 132a is wider than the first slot portion 420a. As shown, when the protruding portion 132a engages with the side walls 428, 429, the connector tab 132 is prevented from being pulled axially through the first slot portion 420a.

[0093] To help retain the connector tab 132 in a radially compressed configuration, and therefore to help connect it with the frame connector 400 when an axial force is generated between the docking station and the frame connector, the second portions 428b, 429b of the side walls 428, 429 are formed as undercut walls, which means that there is a space or recess below each of the second portions 428b, 429b (or between each of the second portions 428b, 429b and the recessed floor surface 424). As illustrated in Figures 17A and 17B, the second portions 428b, 429b formed as undercut walls are inclined with respect to the recessed floor surface 424 (i.e., the second portions 428b, 429b are not perpendicular to the recessed floor surface 424). The angle α between the second portion 428b and the recessed floor surface 424 is less than 90 degrees, and the angle θ between the second portion 429b and the recessed floor surface 424 is less than 90 degrees. In some embodiments, angles α and θ may each be in the range of 45 to 89.9 degrees. In some embodiments, angles α and θ may each be in the range of 75 to 89.9 degrees. In one preferred embodiment, angles α and θ may each be in the range of 81 to 86 degrees. Angles α and θ may be the same or different.

[0094] As illustrated in Figures 17A and 17B, when the frame connector 400 is used to restrain the docking station 136 axially, the tension generated by the biasing of the docking station to the extended configuration pulls the protruding portion of the connector tab (132a in Figure 15) axially against the second portions 428b, 429b. The undercuts of the second portions 428b, 429b convert a portion of the tension into a radial force that pushes the connector tab radially inward toward the central axis of the frame connector 400, thereby improving the retention characteristics of the docking station before deployment. Each of the angles α, θ between the second portions 428b, 429b and the recessed floor surface 424 in the range of 81–86 degrees (in a particular example) has been found to improve the fixation of the docking station to the delivery system when the outer shaft is extended during recapture of the docking station.

[0095] Returning to Figures 13A and 16A, the first portions 428a and 429a may be formed as undercut walls, meaning there is a space or recess beneath each of the first portions 428a and 429a (or between each of the first portions 428a and 429a and the recessed floor surface 424). As illustrated in Figure 16B, the first portions 428a and 428b as undercut walls are inclined with respect to the recessed floor surface 424 (i.e., the first portions 428a and 429b are not perpendicular to the recessed floor surface 424). The angle β between the first portion 428a and the recessed floor surface 424 is less than 90 degrees, and the angle φ between the first portion 429a and the recessed floor surface 424 is less than 90 degrees. In some embodiments, angles β and φ may each be in the range of 45 to 89.9 degrees. In other embodiments, angles β and φ may each be in the range of 75 to 89.9 degrees. In one embodiment, angles β and φ may each be in the range of 81 to 86 degrees. Angles β and φ may be the same or different. In some embodiments, angles β and / or φ may be the same as angles α and / or θ. In other embodiments, angles β and / or φ may be different from angles α and / or θ.

[0096] Returning to Figure 13A, 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 may be rounded and may have undercuts such that the undercuts extend along the entire length of each of the side walls 428, 429. The edges where the side walls 428, 429 intersect with the outer surface portions 417, 418 may also be rounded.

[0097] Referring to Figure 18, one preferred method for connecting the frame connector 400 to the distal portion of the inner shaft 305 (shown in Figure 5A) is by an overmolding process. During the overmolding process, the radial bore 406 of the flange 408 can receive the flow of injected material. Once the material in the radial bore 406 has solidified, it can secure the frame connector 400 to the inner shaft 305. Figure 18 shows the inner shaft 305 extending through the lumen of the outer shaft 309. The frame connector 400 is sized relative to the outer shaft 309 so that the outer shaft 309 can extend over the frame connector 400 and over docking stations positioned around a portion of the inner shaft 305 distal to the frame connector 400.

[0098] Figures 19 and 20 show a portion of the delivery device 300, including the docking station 136 in a compressed configuration. The outer shaft 309 extends to enclose the docking station 136. Each of the connector tabs 132 of the docking station 136 is positioned within the respective recesses 420 of the frame connector 400 and engages with the sidewalls of the recesses 420. The docking station 136 is held in place axially by the frame connector 400 and radially by the outer shaft 309. Naturally, only a portion of the delivery device is shown in Figures 19 and 20. In Figure 5A, the remaining portion of the delivery device (e.g., the portion extending to the nose cone, the portion coupled to the handle, the nose cone, and the handle) is visible.

[0099] The delivery assembly, configured as shown in Figures 19 and 20, can be inserted into the patient's body and advanced through the patient's vascular system to the 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 Figures 6C–6F). During the recapture of the docking station 136, the inner shaft 305 may be under high tensile load while the outer shaft 309 expands to cover the docking station 136. The undercuts in the side walls of the recess 420 convert the tension acting on each 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 Figure 21, thereby maintaining the connection between the delivery device and the docking station.

[0100] Additional examples of the disclosed technology

[0101] In consideration of the above-described implementations of the subject matter disclosed, this application discloses the following additional embodiments. It should be noted that one feature of an embodiment alone, or two or more features of an embodiment incorporated in combination, and optionally in combination with one or more features of one or more further embodiments, are further embodiments similarly included within the disclosure of this application.

[0102] Example 1: The delivery device comprises a handle body having a proximal end, a distal end, a longitudinal axis extending between the proximal and distal ends, and a cavity located between the proximal and distal ends; a carriage member located within the cavity and movable axially relative to the handle body in a direction parallel to the longitudinal axis of the handle body, wherein the carriage member has an internal surface defining an internal bore, and a ground shoulder integrally formed with the internal surface defining a step-down transition portion within the internal bore; and a part positioned within the internal bore of the carriage member and facing the ground shoulder. The device comprises an outer shaft having a proximal end, wherein the proximal end of the outer shaft, the ground 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; an inner shaft extending through the lumen of the outer shaft and fixed to the handle body; and a sealing member disposed around the inner shaft and within the annular groove, wherein the sealing member is positioned to form a seal between the carriage member and the inner shaft at the proximal end of the outer shaft.

[0103] Example 2: Any embodiment of this specification, in particular the delivery device of Example 1, wherein the carriage member further comprises a positioning shoulder integrally formed with the inner surface and displaced axially from the ground shoulder, and the proximal end of the outer shaft abuts against the positioning shoulder of the carriage member to define an annular groove.

[0104] Example 3: A delivery device according to any embodiment of this specification, in particular any one of Examples 1 and 2, wherein the ground shoulder is an annular shoulder.

[0105] Example 4: A delivery device according to any embodiment of this specification, in particular any one of Examples 1 to 3, wherein the carriage member is an integrally molded body.

[0106] Example 5: A delivery device according to any embodiment of this specification, in particular any one of Examples 1 to 4, wherein the outer shaft is coupled to a carriage member and is movable relative to the handle body by the carriage member.

[0107] Example 6: Any embodiment of this specification, in particular any one of Examples 1 to 5, further comprises a first guide member formed in the carriage member and a second guide member formed in the handle body, wherein the first and second guide members guide the axial movement of the carriage member along the longitudinal axis and restrict relative rotational movement between the carriage member and the handle body.

[0108] Example 7: Any embodiment of this specification, in particular the delivery device described in any one of Examples 1 to 5, further comprises opposing first and second longitudinal slots formed in a carriage member and opposing first and second flattened projections formed on a handle body, wherein the opposing first and second flattened projections each extend into the opposing first and second longitudinal slots to guide the axial movement of the carriage member along the longitudinal axis and prevent relative rotational movement between the carriage member and the handle body.

[0109] Example 8: A delivery device according to any embodiment of this specification, in particular any one of Examples 1 to 7, wherein the carriage member comprises a head portion and a stem portion, and an internal bore is formed within the head portion.

[0110] Example 9: Any embodiment of this specification, in particular the delivery device according to Example 8, wherein the stem portion comprises a central opening connected to an internal bore, and the internal bore and the central opening form a passage extending along the length of the carriage member.

[0111] Example 10: A delivery device according to any embodiment of this specification, particularly the one described in Example 9, wherein the head portion is equipped with an external threaded surface.

[0112] Example 11: Any embodiment of this specification, in particular the delivery device described in Example 10, further comprises a drive member rotatably supported within a handle body, the drive member having an internal threaded surface that engages with an external threaded surface of a carriage member by threads, wherein rotation of the drive member relative to the handle body consequently moves the carriage member along its longitudinal axis relative to the handle body.

[0113] Example 12: Any embodiment of this specification, in particular the delivery device according to Example 11, wherein the drive member comprises a barrel portion partially received within a cavity of a handle body and a knob portion operable to rotate the barrel portion relative to the handle body, and internal thread surfaces are formed within the barrel portion and the knob portion.

[0114] Example 13: Any embodiment of this specification, in particular the delivery device described in any one of Examples 1 to 12, further comprises an injection port located at the proximal end of the handle body, the injection port being fluidly connected to the lumen of the inner shaft.

[0115] Example 14: The delivery assembly comprises a delivery device described in any embodiment of this specification, in particular any one of Examples 1 to 13, and an expandable docking station releasably coupled to the delivery device, the expandable docking station configured to receive an artificial heart valve.

[0116] Example 15: The method includes inserting the distal end of any embodiment of this specification, in particular Example 14, into the patient's vascular system; advancing the distal end of the delivery assembly through the patient's vascular system 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.

[0117] Example 16: Any embodiment of this specification, in particular the method of Example 15, wherein moving the carriage member relative to the handle body to release the expandable docking station from the delivery device includes moving the carriage member relative to the handle body to retract the outer shaft and expose the expandable docking station.

[0118] Example 17: Any embodiment of this specification, in particular the method of Example 16, further includes moving the carriage member relative to the handle body to enclose the expandable docking station within the delivery device before inserting the distal end of the delivery assembly into the patient's vascular system.

[0119] Example 18: Any embodiment of this specification, particularly the method of Example 17, wherein moving the carriage relative to the handle body to enclose the expandable docking station within the delivery device includes moving the carriage member relative to the handle body to extend the outer shaft onto the expandable docking station.

[0120] Example 19: A handle for an artificial implant delivery device comprises a handle body having a longitudinal axis and a cavity extending along the longitudinal axis, and a carriage member disposed within the cavity and movable axially relative to the longitudinal axis of the handle body, wherein the carriage member comprises a carriage body having an internal surface defining an internal bore and a ground shoulder integrally formed with the internal surface and defining a step-down transition within the internal bore, and a portion of the internal surface adjacent to the ground shoulder and step-down transition forms a portion of an annular groove configured to receive a sealing member.

[0121] Example 20: Any embodiment of this specification, in particular the handle described in Example 19, wherein the ground shoulder is an annular shoulder.

[0122] Example 21: A handle according to any embodiment of this specification, particularly Example 19 or 20, wherein the carriage body further comprises a positioning shoulder formed integrally with the inner surface and displaced axially from the ground shoulder, and a portion of the annular groove is positioned between the ground shoulder and the positioning shoulder.

[0123] Example 22: Any embodiment of this specification, particularly the handles described in Examples 19-21, wherein the carriage body is a single-piece molded body.

[0124] Example 23: Any embodiment of this specification, in particular any one of Examples 19 to 22, further comprises opposing first and second longitudinal slots formed within the carriage body and opposing first and second flattened projections formed on the handle body, the opposing first and second flattened projections each extending into the opposing first and second longitudinal slots to guide the movement of the carriage member along the longitudinal axis of the handle body.

[0125] Example 24: A handle according to any embodiment of this specification, in particular any one of Examples 19 to 23, wherein the carriage body comprises a head portion and a stem portion, and an internal bore is formed within the head portion.

[0126] Example 25: Any embodiment of this specification, in particular the handle described in Example 24, wherein the stem portion comprises a central opening connected to an internal bore, and the internal bore and the central opening form a passage extending along the length of the carriage body.

[0127] Example 26: A handle according to any embodiment of this specification, in particular any one of Examples 24 and 25, wherein the head portion comprises an external threaded surface.

[0128] Example 27: Any embodiment of this specification, in particular the handle of Example 26, further comprises a drive member rotatably supported within the handle body, the drive member having an internal threaded surface that engages with an external threaded surface and a threaded surface, and the rotation of the drive member relative to the handle body consequently moves the carriage member along the longitudinal axis relative to the handle body.

[0129] Example 28: Any embodiment of this specification, in particular the handle according to Example 27, wherein the drive member comprises a barrel portion partially received within a cavity of the handle body and a knob portion operable to rotate the barrel portion relative to the handle body, and internal thread surfaces are formed within the barrel portion and the knob portion.

[0130] Example 29: Any embodiment of this specification, in particular any one of Examples 19 to 25, of the handle further comprises a drive member operably coupled to the carriage member for moving the carriage member relative to the handle body.

[0131] Example 30: The carriage for the artificial implant delivery device comprises a one-piece molded body having an internal surface defining an internal bore and a ground shoulder formed integrally with the internal surface and defining a step-down transition within the internal bore, wherein a portion of the internal surface adjacent to the ground shoulder and the step-down transition forms a portion of an annular groove configured to receive a sealing member.

[0132] Example 31: Any embodiment of this specification, in particular the carriage described in Example 30, wherein the ground shoulder is an annular shoulder.

[0133] Example 32: A carriage according to any embodiment of this specification, in particular any one of Examples 30 and 31, wherein the integrally molded body further comprises a positioning shoulder formed integrally with the inner surface and axially displaced from the ground shoulder, and a portion of the annular groove is positioned between the ground shoulder and the positioning shoulder.

[0134] Example 33: A carriage according to any embodiment of this specification, in particular any one of Examples 30 to 32, wherein the integrally molded body comprises a head portion and a stem portion, and an internal bore is formed within the head portion.

[0135] Example 34: Any embodiment of this specification, in particular the carriage described in Example 33, wherein the stem portion comprises a central opening connected to an internal bore, and the internal bore and the central opening form a passage extending along the length of the integrally molded body.

[0136] Example 35: A carriage according to any embodiment of this specification, in particular any one of Examples 33 and 34, wherein the head portion comprises an external threaded surface.

[0137] Example 36: A carriage according to any embodiment of this specification, in particular any one of Examples 34 and 35, further comprising opposing first and second longitudinal slots formed at least partially within the stem portion and extending parallel to the passage.

[0138] Example 37: Any embodiment of this specification, in particular the carriage of Example 36, wherein at least one of the first and second longitudinal slots is connected to a passage.

[0139] Example 38: A method for forming components of an artificial implant delivery device includes fixing a core pin in a mold cavity and injecting a thermoplastic material into the mold cavity to form a molded body having an internal surface defining an internal bore and a ground shoulder formed integrally with the internal surface and defining a step-down transition within the internal bore.

[0140] Example 39: A method for forming a component of an artificial implant delivery device includes fixing a core pin in a mold cavity and injecting a thermoplastic material into the mold cavity to form a molded body having an internal surface defining an internal bore, a ground shoulder formed integrally with the internal surface and defining a step-down transition shoulder within the internal bore, and a positioning shoulder formed integrally with the internal surface and displaced axially from the ground shoulder.

[0141] Example 40: The delivery device comprises 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, wherein the outer shaft has a first lumen; an inner shaft extending through the first lumen of the outer shaft, wherein the inner shaft has a second lumen and one or more fluid ports that fluidly connect the second lumen to the first lumen; and an injection port that fluidly connects to the second lumen of the inner shaft, wherein both the first and second lumen are flushable with fluid through the injection port.

[0142] Example 41: A delivery device of any embodiment of this specification, in particular Example 40, comprising an inner shaft made of a reinforced tube, with one or more fluid ports formed in the wall of the reinforced tube.

[0143] Example 42: Any embodiment of this specification, in particular the delivery device of Example 41, 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 a second lumen is formed within the inner layer.

[0144] Example 43: Any embodiment of this specification, in particular the delivery device of Example 42, wherein the reinforcing layer comprises a braided material.

[0145] Example 44: Any embodiment of this specification, in particular the delivery device of Example 43, wherein each fluid port includes a first opening in an inner layer, a second opening in an outer layer radially aligned with the first opening, and a portion of a braided tube positioned between the first and second openings.

[0146] Example 45: A delivery device according to any embodiment of this specification, in particular any one of Examples 41 to 44, wherein one or more fluid ports are longitudinally aligned on a reinforced tube.

[0147] Example 46: A delivery device according to any embodiment of this specification, in particular any one of Examples 41-44, wherein one or more fluid ports form a circular pattern around a reinforced tube.

[0148] Example 47: A delivery device according to any embodiment of this specification, in particular any one of Examples 41-44, wherein one or more fluid ports form a helical pattern around a reinforced tube.

[0149] Example 48: Any embodiment of this specification, in particular the delivery device described in any one of Examples 41 to 47, further comprises a cover tube positioned over at least a portion of the reinforced tube, the cover tube having one or more windows positioned to expose one or more fluid ports.

[0150] Example 49: A delivery device according to any embodiment of this specification, in particular any one of Examples 40 to 48, wherein one or more fluid ports are formed in a portion of an inner shaft adjacent to the handle body.

[0151] Example 50: Any embodiment of this specification, in particular any one of Examples 40 to 49, further comprises a carriage member, which is located in an elongated cavity and is movable relative to the handle body along the longitudinal axis of the handle body, the carriage member comprising a carriage body having a passage defined therein, the proximal end of an outer shaft positioned within the passage.

[0152] Example 51: Any embodiment of this specification, in particular the delivery device of Example 50, further comprises a sealing member positioned within the passage, the sealing member positioned to form a seal at the proximal end of the outer shaft.

[0153] Example 52: The delivery assembly comprises a delivery device described in any embodiment of this specification, in particular any one of Examples 40 to 51, and an expandable docking station for an expandable valve releasably coupled to the delivery device.

[0154] Example 53: The method includes inserting the distal end of any embodiment of this specification, in particular Example 52, of the delivery assembly into the patient's vascular system; advancing the delivery assembly through the patient's vascular system 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.

[0155] Example 54: The method comprises providing a reinforced pipe including an inner layer, a reinforcing layer placed on the inner layer, and an outer layer placed on the reinforcing layer, and ablating the reinforced pipe at one or more locations to form one or more fluid ports within the reinforced pipe.

[0156] Example 55: The method comprises placing a cover pipe having one or more windows on a reinforced pipe, and ablating the reinforced pipe at one or more locations exposed through the one or more windows to form one or more fluid ports within the reinforced pipe.

[0157] Example 56: Any embodiment of this specification, particularly the method of Example 55, wherein the reinforced tube comprises an inner layer, a reinforcing layer placed on the inner layer, and an outer layer placed on the inner layer, and ablation of the reinforced tube includes ablation of the inner layer and the outer layer without ablation of the reinforcing layer.

[0158] Example 57: A shaft assembly for an artificial implant delivery device comprises 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 that fluidly connect the second lumen to the first lumen. The inner shaft further comprises a cover tube positioned on the reinforced tube, the cover tube having one or more windows positioned to expose one or more fluid ports to the first lumen.

[0159] Example 58: Any embodiment of this specification, in particular the shaft assembly of Example 57, wherein the reinforced tube comprises an inner layer, a reinforcing layer positioned on the inner layer, and an outer layer positioned on the reinforcing layer, and a second lumen is formed within the inner layer.

[0160] Example 59: Any embodiment of this specification, in particular the shaft assembly of Example 58, wherein the reinforcing layer includes a braided material.

[0161] Example 60: Any embodiment of this specification, in particular the shaft assembly of Example 59, wherein each fluid port comprises a first opening in an inner layer, a second opening in an outer layer radially aligned with the first opening, and a portion of braided material positioned between the first and second openings.

[0162] Example 61: The delivery device comprises an elongated shaft having a proximal end portion and a distal end portion, wherein the proximal end portion is configured to be positioned outside the patient's body during a delivery procedure, and the distal end portion is configured to be positioned inside the patient's body during a delivery procedure; and a frame connector coupled to the distal end portion of the elongated shaft and configured to releasely connect an artificial implant to the delivery device, wherein the frame connector comprises a connector body having an external 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, a recess floor surface, and opposing first and second side walls extending from the recess floor surface to the external surface and connected to the first and second slot portions, wherein at least the first portion of each of the first and second side walls connected to the second slot portion includes an undercut from the external surface to the recess floor surface.

[0163] Example 62: Any embodiment of this specification, in particular the delivery device of Example 61, wherein the recessed floor surface is recessed relative to the outer surface of the connector body, and the first and second side walls protrude from the opposing sides of the recessed floor surface.

[0164] Example 63: A delivery device according to any embodiment of this specification, in particular Example 62, wherein at least the first portion of each of the first and second side walls of the recess is inclined at an angle with respect to the recess floor of the recess.

[0165] Example 64: Any embodiment of this specification, in particular the delivery device of Example 63, wherein the angle is in the range of 75 to 89.9 degrees.

[0166] Example 65: Any embodiment of this specification, in particular the delivery device of Example 63, wherein the angle is in the range of 81 to 86 degrees.

[0167] Example 66: A delivery device according to any embodiment of this specification, in particular any one of Examples 62 to 65, wherein the second portion of each of the first and second side walls connected to the first slot portion of the recess includes an undercut.

[0168] Example 67: A delivery device according to any embodiment of this specification, in particular any one of Examples 62 to 66, wherein the recess comprises end walls displaced longitudinally from the first and second side walls of the recess, and the end walls are connected to a second slot portion.

[0169] Example 68: Any embodiment of this specification, in particular the delivery apparatus of Example 67, wherein the height of each of the first and second side walls of the recess relative to the recess floor surface is greater than the height of the end wall of the recess relative to the recess floor surface.

[0170] Example 69: A delivery device according to any embodiment of this specification, in particular any one of Examples 61 to 68, wherein each of the first and second side walls of the recess includes a rounded corner to which the first and second slot portions of the recess are connected.

[0171] Example 70: A delivery device according to any embodiment of this specification, in particular any one of Examples 61 to 69, wherein the recess is one of a plurality of recesses, and the plurality of recesses are formed on the outside of the connector body at angularly spaced positions.

[0172] Example 71: A delivery device according to any embodiment of this specification, in particular any one of Examples 61 to 70, wherein the connector body comprises an internal bore and an elongated shaft extends through the internal bore.

[0173] Example 72: A delivery device according to any embodiment of this specification, in particular any one of Examples 61 to 71, wherein the frame connector comprises a flange formed at the end of the connector body, and the flange includes a plurality of radial holes.

[0174] Example 73: A delivery device according to any embodiment of this specification, particularly Example 72, wherein a portion of an elongated shaft extends over a flange and through a radial hole.

[0175] Example 74: A delivery device according to any embodiment of this specification, in particular any one of Examples 61 to 73, wherein the recess is open on the external surface.

[0176] Example 75: A frame connector for an artificial implant delivery device comprises a connector body having an outer surface, a recessed surface, and opposing first and second side walls, wherein the recessed surface is spaced radially inward from the outer surface and comprises a first slot portion having a first width and a second slot portion having a second width greater than the first width, and the opposing first and second side walls extend radially from the recessed surface to the outer surface and are connected to the first and second slot portions, with at least the first portion of each of the first and second side walls connected to the second slot portion forming an angle with respect to the recessed surface in the range of 75 to 89.9 degrees.

[0177] Example 76: Any embodiment of this specification, in particular the frame connector of Example 75, wherein the angle is in the range of 81 to 86 degrees.

[0178] Example 77: A frame connector according to any embodiment of this specification, in particular any one of Examples 75 and 76, wherein the second portion of each of the first and second side walls connected to the first slot portion forms an angle with respect to a recessed surface in the range of 75 to 89.9 degrees.

[0179] Example 78: A frame connector according to any embodiment of this specification, in particular any one of Examples 75-77, wherein each of the first and second side walls has an undercut extending along the entire length of each first and second side wall.

[0180] Example 79: A frame connector according to any embodiment of this specification, in particular any one of Examples 75-78, wherein each of the first and second side walls includes a rounded corner into which the first and second slot portions are connected.

[0181] Example 80: A frame connector according to any embodiment of this specification, in particular any one of Examples 75 to 79, wherein the recessed surface is one of a plurality of recessed surfaces formed at angularly spaced positions on the outside of the connector body.

[0182] Example 81: A frame connector according to any embodiment of this specification, in particular any one of Examples 75 to 80, wherein the connector body comprises an internal bore.

[0183] Example 82: Any embodiment of this specification, in particular any one of Examples 75 to 81, of the frame connector further includes a flange formed at the end of the connector body, the flange including a plurality of radial holes.

[0184] Example 83: The delivery assembly comprises a self-expandable docking station including at least one connector tab, wherein at least one connector tab has an overhang, and a frame connector having a connector body having at least one recess for receiving and holding at least one connector tab, wherein at least one recess comprises an overhang, a recessed floor surface, and a slot portion for receiving opposing first and second side walls connected to the slot portion and the recessed floor surface, wherein at least one portion of each of the first and second side walls forms an angle with respect to the recessed floor surface in the range of 75 to 89.9 degrees.

[0185] Unless otherwise stated, any features described herein in relation to any embodiment may be combined with other features described in any one or more of the other embodiments.

[0186] Given the many possible ways in which the principles of this disclosure may be applied, it should be recognized that the illustrated configurations illustrate embodiments of the disclosed technology and should not be construed as limiting the scope of this disclosure or the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A delivery device, A handle body having a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, and a cavity positioned between the proximal end and the distal end, A carriage member disposed within the cavity and movable axially relative to the handle body in a direction parallel to the longitudinal axis of the handle body, wherein the carriage member has an internal surface defining an internal bore, and a ground shoulder integrally formed with the internal surface and defining a step-down transition portion within the internal bore, An outer shaft having a proximal end positioned within the internal bore of the carriage member and facing the ground shoulder, wherein the proximal end of the outer shaft, the ground shoulder of the carriage member, and a portion of the internal surface of the carriage member adjacent to the step-down transition define an annular groove. An inner shaft extending through the inner cavity of the outer shaft and fixed to the handle body, A delivery device comprising: a sealing member disposed around the inner shaft and within the annular groove, wherein the sealing member is positioned between the carriage member and the inner shaft to form a seal at the proximal end of the outer shaft.

2. The delivery device according to claim 1, wherein the carriage member further comprises a positioning shoulder formed integrally with the inner surface and displaced axially from the ground shoulder, and the proximal end of the outer shaft abuts against the positioning shoulder of the carriage member to define the annular groove.

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

4. The delivery device according to any one of claims 1 to 3, wherein the carriage member is an integrally molded body.

5. The delivery device according to any one of claims 1 to 4, wherein the outer shaft is coupled to the carriage member and is movable relative to the handle body by the carriage member.

6. A first guide member formed within the carriage member, The handle body further comprises a second guide member formed within the handle body, The delivery device according to any one of claims 1 to 5, wherein the first and second guide members guide the axial movement of the carriage member along the longitudinal axis and restrict the relative rotational movement between the carriage member and the handle body.

7. Opposing first and second longitudinal slots formed within the carriage member, The handle body further comprises opposing first and second flat protrusions formed on the handle body, The delivery device according to any one of claims 1 to 5, wherein the opposing first and second flat protrusions each extend into the opposing first and second longitudinal slots, guiding the axial movement of the carriage member along the longitudinal axis and preventing relative rotational movement between the carriage member and the handle body.

8. The delivery device according to any one of claims 1 to 7, wherein the carriage member comprises a head portion and a stem portion, and the internal bore is formed within the head portion.

9. The delivery device according to claim 8, wherein the stem portion has a central opening connected to the internal bore, and the internal bore and the central opening form a passage extending along the length of the carriage member.

10. The delivery device according to claim 9, wherein the head portion is provided with an external threaded surface.

11. A drive member rotatably supported within the handle body, the drive member further comprising an internal threaded surface that engages with the external threaded surface of the carriage member by threads, The delivery device according to claim 10, wherein the rotation of the drive member relative to the handle body results in the movement of the carriage member relative to the handle body along the longitudinal axis.

12. The delivery device according to claim 11, wherein the drive member comprises a barrel portion 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 the internal screw surface is formed within the barrel portion and the knob portion.

13. The delivery device according to any one of claims 1 to 12, further comprising an injection port located at the proximal end of the handle body, wherein the injection port is fluidly connected to the lumen of the inner shaft.

14. It is a delivered assembly product, A delivery device according to any one of claims 1 to 13, A delivery assembly comprising an expandable docking station releasably coupled to the delivery device, wherein the expandable docking station is configured to receive an artificial heart valve.

Images