Seals for delivery devices

Abstract

Apparatuses and methods for seals are disclosed. For example, a delivery device includes: a cannula shaft including a first section and a second section, where the second section includes an inwardly facing outer surface and an outwardly facing outer surface, where the second section includes a lubricating coating; and a seal coupled to the second section of the sleeve shaft.

Description

[0001] Cross-reference to related applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 582,373, filed on September 13, 2023, and U.S. Provisional Patent Application No. 63 / 482,210, filed on January 30, 2023, which are incorporated herein by reference in their entireties. Technical Field

[0002] The present disclosure relates to seals for delivery devices of prosthetic medical devices. Background Art

[0003] The human heart may be subject to various valve diseases. These valve diseases may lead to significant dysfunction of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial valves, as well as many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various procedures to deliver prosthetic medical devices to locations in the body that are not easily accessible by surgery or to locations that are desired to be accessible without surgery. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vascular system ( For example The prosthetic valve is then moved through the femoral artery or femoral vein until it 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, thereby actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of a delivery device so that the prosthetic valve can self-expand to its functional size.

[0004] In some examples, a docking device can be first implanted within a native valve and can be configured to receive a prosthetic valve and secure (e.g., anchor) the prosthetic valve at a desired location within the native valve. For example, the docking device can create a more rounded and / or more stable anchoring site at the native valve annulus, allowing the prosthetic valve to be expanded and implanted therein. A transcatheter delivery device can be used to deliver the docking device to the implantation site. Summary of the Invention

[0005] Prosthetic heart valves, docking devices, delivery apparatuses, and methods for implanting prosthetic heart valves are described herein. The disclosed prosthetic heart valves, docking devices, delivery apparatuses, and methods can, for example, provide a passive hemostatic seal around a shaft having an open channel, such that the open channel is sealed independently of a locking mechanism of the shaft. Thus, the devices and methods disclosed herein can overcome, among other things, one or more deficiencies of typical prosthetic heart valves, docking devices, and associated delivery apparatuses.

[0006] A delivery device may include a handle and one or more shafts coupled to the handle.

[0007] In some examples, a delivery device may include a handle, a shaft coupled to the handle, and a passive seal coupled to the shaft, wherein the seal maintains a steady state when the shaft moves relative to the seal.

[0008] In some examples, a delivery device may include: a sealing housing; a first shaft extending through the sealing housing and including an outward-facing surface and an inward-facing surface, wherein the inward-facing surface defines an open channel; a second shaft including a first segment and a second segment, wherein the first segment is disposed within the open channel and wherein the second segment extends out of the open channel and is angled relative to the first segment; and a seal coupled to the first shaft, the seal comprising a first sealing portion and a second sealing portion, wherein the first sealing portion seals a first gap between the sealing housing and the outward-facing surface of the first shaft, wherein the second sealing portion seals a second gap between the sealing housing and the inward-facing surface of the first shaft, wherein the seal maintains a steady state as the first shaft moves relative to the seal.

[0009] In some examples, a delivery device may include: a sealing housing; a first shaft extending through the sealing housing and including an outward-facing surface and an inward-facing surface, wherein the inward-facing surface defines an open channel; a second shaft including a first segment and a second segment, wherein the first segment is disposed within the open channel and wherein the second segment extends out of the open channel and is angled relative to the first segment; and a sealing assembly coupled to the first shaft, the seal comprising a first sealing member and a second sealing member, wherein the first sealing member seals a first gap between the sealing housing and the outward-facing surface of the first shaft, wherein the second sealing member seals a second gap between the sealing housing and the inward-facing surface of the first shaft, wherein the seal maintains a steady state as the first shaft moves relative to the seal.

[0010] In some examples, a delivery device may include: a sealing housing; a shaft extending through the sealing housing, wherein the shaft includes an outer surface, wherein the outer surface includes an inward-facing portion and an outward-facing portion; and a sealing member disposed within the sealing housing, wherein the sealing member includes an inner surface defining an opening, wherein the shaft extends through the opening of the sealing member, wherein the sealing member includes an inner protrusion having an engagement surface, wherein the engagement surface seals against the inward-facing portion of the outer surface of the shaft, wherein the sealing member provides hemostasis when the shaft moves relative to the sealing member.

[0011] In some examples, a delivery device may include: a cannula comprising a first segment and a second segment, wherein the second segment comprises an inwardly facing outer surface and an outwardly facing outer surface, wherein the second segment comprises a lubricious coating; and a seal coupled to the second segment of the cannula.

[0012] In some examples, a delivery device may include: a sealed housing defining a lubricant chamber containing a lubricant; a seal disposed within the sealed housing; and a cannula extending through the sealed housing, the cannula including a first segment and a second segment, wherein the second segment extends through the lubricant chamber and the seal, wherein the second segment includes an inwardly facing outer surface and an outwardly facing outer surface.

[0013] A seal assembly for a delivery device may include a plurality of seal members coupled together and forming a seal therebetween, wherein each seal member defines an axially extending opening.

[0014] In some examples, a sealing assembly for a delivery device may include: a first sealing member defining a first opening extending through the first sealing member in an axial direction, wherein the first opening includes an inward-facing surface that is configured to seal against an outward-facing surface of the shaft; and a second sealing member coupled to the first sealing member, the second sealing member defining a second opening extending through the second sealing member in the axial direction, wherein the second sealing member includes an inner protrusion extending into the second opening in a radial direction, wherein the inner protrusion includes an outward-facing engagement surface that is configured to seal against the inward-facing surface of the shaft.

[0015] A seal for a delivery device may include a body defining an opening for a shaft, wherein the body includes an inwardly facing surface and an outwardly facing surface configured to seal against the shaft.

[0016] In some examples, a seal for a delivery device may include a body having a first sealing portion and a second sealing portion, the first sealing portion being axially spaced apart from the second sealing portion, wherein the first sealing portion includes an opening having an inwardly facing surface, and wherein the second sealing portion includes an inner protrusion having an outwardly facing surface.

[0017] The various innovations of this disclosure may be used in combination or individually. This summary is provided to introduce a series of concepts further described in the detailed description below in a simplified form. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description, claims, and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 Stages in an example mitral valve replacement procedure are schematically illustrated in which a guide catheter and guidewire are inserted into a patient's blood vessel and guided through the vessel and into the patient's heart toward the heart's native mitral valve.

[0019] Figure 2A Another stage in an example mitral valve replacement procedure is schematically illustrated in which a docking device delivery apparatus extending through a guide catheter implants a docking device for a prosthetic heart valve at the native mitral valve.

[0020] Figure 2B Another stage in an example mitral valve replacement procedure is schematically shown, wherein Figure 2A The docking device is fully implanted in the patient's native mitral valve and the docking device delivery device is removed from the patient.

[0021] Figure 3A Another stage in an example mitral valve replacement procedure is schematically illustrated in which a prosthetic heart valve delivery device extending through a guide catheter implants a prosthetic heart valve into an implanted docking device at the native mitral valve.

[0022] Figure 3B Another stage in an example mitral valve replacement procedure is schematically illustrated, wherein the prosthetic heart valve is fully implanted within a docking device at the native mitral valve and the prosthetic heart valve delivery device has been removed from the patient.

[0023] Figure 4 Another stage in an example mitral valve replacement procedure is schematically illustrated, wherein the guide catheter and guidewire have been removed from the patient.

[0024] Figure 5 is a side view of a docking apparatus according to one example.

[0025] Figure 6A is a side view of a delivery apparatus for a docking device according to one example.

[0026] Figure 6B Depicts Figure 6A part of a delivery device.

[0027] Figure 7 Depicts Figure 6A Part of a shaft assembly of a delivery device.

[0028] Figure 8 is a perspective view of an active hemostatic seal configured to seal around a cannula shaft of a delivery device for a docking device.

[0029] Figure 9 is located in a sealed housing surrounding the shaft of the quill Figure 8 Perspective view of an active hemostatic seal.

[0030] Figure 10 is a cross-sectional side view of a passive hemostatic seal assembly positioned within a seal housing according to an example.

[0031] Figure 11 yes Figure 10 A perspective view of the sealing assembly.

[0032] Figures 12A-13B yes Figure 10 Additional views of the sealing member of the sealing assembly.

[0033] Figure 14 is connected to the sleeve shaft Figure 10 A perspective view of the sealing assembly.

[0034] Figure 15 yes Figure 10 A perspective view of a segment of a sealing housing.

[0035] Figure 16 is a cross-sectional side view of a passive hemostatic seal positioned within a seal housing according to an example.

[0036] Figure 17 yes Figure 16 A perspective view of a seal with the cover of the seal housing removed for illustration purposes.

[0037] Figures 18A-18D yes Figure 16 Additional views of the sealing components of the seal.

[0038] Figure 19 is connected to the sleeve shaft Figure 16 A perspective view of the seal.

[0039] Figure 20 is connected to the sleeve shaft Figure 16 A cross-sectional perspective view of a seal.

[0040] Figure 21 is a perspective view of a passive hemostatic seal according to one example.

[0041] Figure 22 yes Figure 21 End view of the seal.

[0042] Figure 23 is a side view of a proximal portion of a cannula shaft according to an example.

[0043] Figure 24 It is along Figure 23 A cross-sectional view of the quill taken at section 24-24.

[0044] Figure 25 is a cross-sectional side view of a passive hemostatic seal assembly and lubricant chamber positioned within a seal housing according to an example. DETAILED DESCRIPTION

[0045] General considerations For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and subcombinations with one another. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or problems solved.

[0046] Although the operations of some examples in the disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this description encompasses rearrangement unless the specific language set forth below requires a particular ordering. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. In addition, for the sake of simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are easily discernible by those of ordinary skill in the art.

[0047] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises." Further, the term "coupled" generally means a physical, mechanical, chemical, magnetic, and / or electrical connection or coupling, and does not exclude the presence of intervening elements between the coupled or associated items absent specific language to the contrary.

[0048] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and further from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is further from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions, unless expressly defined otherwise.

[0049] As used herein, "such as" means "for example," and "ie" means "that is to say."

[0050] Introduction to public technology Described herein are examples of steerable delivery devices (sometimes referred to as steerable catheters) that can be used to deliver implantable medical devices (e.g., prosthetic heart valves, docking devices), tools, medications, or other therapeutic products to a location within the body of a subject through the subject's vasculature. Examples of procedures for which steerable catheters are suitable include neurological, urological, gynecological, reproductive (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures involving access to any body duct or cavity. Specific examples include: placement of implants, including stents, grafts, embolization coils, etc.; positioning of imaging devices and / or components thereof, including ultrasonic transducers; and positioning of energy sources, such as those used to perform lithotripsy, such as RF sources, ultrasonic transmitters, electromagnetic sources, laser sources, heat sources, etc.

[0051] In connection therewith, various systems, devices, methods, etc. are described herein that, in some examples, can create a passive seal for a shaft of a delivery device such that the shaft is sealed (e.g., a steady-state seal) as the shaft translates relative to other components of the delivery device.

[0052] Examples of the Disclosed Technology Figure 1-4 An example of a transcatheter heart valve replacement procedure (eg, a mitral valve replacement procedure) utilizing a docking device 52 and a prosthetic heart valve 62 is depicted according to one example. During the procedure, the user first uses a guide catheter 30 ( Figure 1 ) creates a passage to the patient's native heart valve. The user then uses the docking device delivery device 50 ( Figure 2A ) delivering and implanting the docking device 52 at the patient's native heart valve, and then removing the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 ( Figure 2B The user then uses the prosthetic valve delivery device 60 ( Figure 3A) implants the prosthetic heart valve 62 within the implanted docking device 52. Thereafter, the user removes the prosthetic valve delivery device 60 from the patient 10 ( Figure 3B ) and the guide catheter 30 ( Figure 4 ).

[0053] Figure 1 A stage in a mitral valve replacement procedure according to one example is depicted, wherein a guide catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of a patient 10 and guided through the blood vessel 12, into the heart 14 of the patient 10, and toward the native mitral valve 16. Together, the guide catheter 30 and the guidewire 40 can provide a path for a docking device delivery apparatus 50 and a prosthetic valve delivery apparatus 60 to pass through and be guided along the path to the implantation site (the native mitral valve 16 or the native mitral valve annulus). As shown, the heart 14 is schematically illustrated. For example, for illustrative purposes, the anterior leaflet and chordae tendineae of the native mitral valve 16 are omitted, such that only a portion of the posterior leaflet of the native mitral valve 16 is shown.

[0054] Initially, the user may first create an incision in the patient's body to access the blood vessel 12. For example, Figure 1 In the example shown, a user can make an incision in the patient's groin to access the femoral vein. Thus, in such an example, the blood vessel 12 can be the femoral vein.

[0055] After making an incision at the blood vessel 12, the user can insert the guide catheter 30, the guide wire 40 and / or an additional device (such as an introducer device or a transseptal puncture device) into the blood vessel 12 through the incision. The guide catheter 30 (which may also be referred to as an "introducer device", "introducer" or "introducer sheath") is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., a docking device delivery device 50 and a prosthetic valve delivery device 60) into and through the blood vessel 12, and can extend through the blood vessel 12 and into the heart 14, but can stop before the native mitral valve 16. The guide catheter 30 may include a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend through the blood vessel 12 and into the heart 14, while the handle 32 remains outside the patient 10 and can be operated by the user to manipulate the shaft 34 ( Figure 1 ).

[0056] The guidewire 40 is configured to guide a delivery device (e.g., a guide catheter 30, a docking device delivery device 50, a prosthetic valve delivery device 60, additional catheters, etc.) and its associated device (e.g., a docking device, a prosthetic heart valve, etc.) to an implantation site within the heart 14 and, therefore, may extend through the blood vessel 12 and into the left atrium 18 of the heart 14 ( Figure 1 ) and in some examples passes through the native mitral valve 16 and into the left ventricle of the heart 14.

[0057] In some cases, a transseptal puncture device or catheter can be used to initially access the left atrium 18 prior to inserting the guidewire 40 and guide catheter 30. For example, after making an incision in the blood vessel 12, the user can insert the transseptal puncture device through the incision into the blood vessel 12. The user can guide the transseptal puncture device through the blood vessel 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20). The user can then make a small incision in the atrial septum 22 of the heart 14 to allow access from the right atrium 20 to the left atrium 18. The user can then insert and advance the guidewire 40 through the transseptal puncture device in the blood vessel 12 and through the incision in the atrial septum 22 into the left atrium 18. Once the guidewire 40 is positioned within the left atrium 18 and / or left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the blood vessel 12 and, over the guidewire 40 ( Figure 1 ) Advance the guide catheter 30 into the left atrium 18.

[0058] In some cases, before the guide catheter 30 is inserted into the blood vessel 12, an introducer device can be inserted through the lumen of the guide catheter 30. In some cases, the introducer device can include a tapered end that extends beyond the distal tip of the guide catheter 30 and is configured to guide the guide catheter 30 into the left atrium 18 via the guidewire 40. Additionally, in some cases, the introducer device can include a proximal portion that extends beyond the proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain within the patient 10. The guide catheter 30 is then in place to receive the implant delivery device and help guide the implant delivery device to the left atrium 18, as further described below.

[0059] Figure 2A Another stage in an example mitral valve replacement procedure is depicted in which a docking device 52 is implanted at the native mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery apparatus 50 (which may also be referred to as an "implantation catheter" and / or a "docking device delivery apparatus").

[0060] Generally, the docking device delivery apparatus 50 includes a delivery shaft 54, a handle 56, and a pusher assembly 58. The delivery shaft 54 ​​is configured to be advanced by a user through the patient's vasculature (blood vessel 12) and to the implantation site (e.g., the native mitral valve 16), and can be configured to retain the docking device 52 in the distal portion 53 of the delivery shaft 54. In some examples, the distal portion 53 of the delivery shaft 54 ​​retains the docking device 52 therein in a straightened delivery configuration.

[0061] The handle 56 of the docking device delivery apparatus 50 is configured to be grasped and / or otherwise held by a user outside the body of the patient 10 to advance the delivery shaft 54 ​​through the patient's vasculature (eg, blood vessel 12 ).

[0062] In some examples, the handle 56 can include one or more articulating members 57 (or rotatable knobs) configured to facilitate guiding the delivery shaft 54 ​​through the blood vessel 12. For example, the one or more articulating members 57 can include one or more of a knob, button, wheel, and / or other type of physically adjustable control member configured to be adjusted by a user to cause the distal portion 53 of the delivery shaft 54 ​​to flex, bend, twist, rotate, and / or otherwise articulate to facilitate guiding the delivery shaft 54 ​​through the blood vessel 12 and within the heart 14.

[0063] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at an implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 can be configured to be adjusted by a user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. The shaft of the pusher assembly 58 can extend through the delivery shaft 54 ​​and can be positioned adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 can be releasably coupled to the shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery apparatus 50, such that the docking device 52 can be released after being deployed at the native mitral valve 16.

[0064] Further details of the docking device delivery apparatus and its variations are described in International Publication No. WO2020 / 247907, which is incorporated herein by reference in its entirety.

[0065] Reference again Figure 2A After positioning the guide catheter 30 within the left atrium 18, the user can insert the docking device delivery device 50 (e.g., delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 ​​of the docking device delivery device 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. The user can then continue to advance the delivery shaft 54 ​​of the docking device delivery device 50 along the guidewire 40 through the blood vessel 12 until the delivery shaft 54 ​​reaches the left atrium 18, as shown. Figure 2A Specifically, a user can advance the delivery shaft 54 ​​of the docking device delivery device 50 toward the patient 10 by grasping the handle 56 of the docking device delivery device 50 and applying force thereon (e.g., pushing the handle). As the delivery shaft 54 ​​is advanced through the blood vessel 12 and the heart 14, the user can adjust one or more hinged members 57 of the handle 56 to navigate various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0066] Once the delivery shaft 54 ​​reaches the left atrium 18 and extends out of the distal end of the guide catheter 30, the user can use the handle 56 (e.g., the hinge member 57) to position the distal portion 53 of the delivery shaft 54 ​​at and / or near the posteromedial commissure of the native mitral valve 16. The user can then use the shaft of the pusher assembly 58 to push the docking device 52 out of the distal portion 53 of the delivery shaft 54 ​​to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0067] In some examples, the docking device 52 can be constructed from, formed from, and / or include a shape memory material and, thus, can return to its initial, pre-formed shape when it is free of and no longer constrained by the delivery shaft 54. As one example, the docking device 52 can be initially shaped as a coil and, thus, can wrap around the leaflets 24 of the native mitral valve 16 when it is free of the delivery shaft 54 ​​and returns to its initial coiled configuration.

[0068] When pushing the ventricular portion of the docking device 52 (e.g., Figure 2A After deploying the portion of the docking device 52 shown in the figure that is configured to be positioned within the left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user can then deploy the remaining portion of the docking device 52 (e.g., the atrial portion of the docking device 52) from the delivery shaft 54 ​​within the left atrium 18 by retracting the delivery shaft 54 ​​away from the posteromedial commissure of the native mitral valve 16.

[0069] After deploying and implanting the docking device 52 at the native mitral valve 16, the user can disconnect the docking device delivery apparatus 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery apparatus 50, the user can retract the docking device delivery apparatus 50 from the blood vessel 12 and away from the patient 10, allowing the user to deliver and implant the prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0070] Figure 2B This stage in the mitral valve replacement procedure is depicted in which the docking device 52 has been fully deployed and implanted at the native mitral valve 16, and the docking device delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10, such that only the guidewire 40 and the guide catheter 30 remain within the patient 10. In some examples, after the docking device delivery apparatus is removed, the guidewire 40 can be advanced out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 ( Figure 2A ). Thus, the guidewire 40 can help guide the prosthetic valve delivery device 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0071] like Figure 2B As shown, the docking device 52 can include a plurality of turns (or coils) that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 has a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or contour of the prosthetic heart valve to be implanted. Thus, the docking device 52 can provide a tighter fit between the prosthetic heart valve and the native mitral valve 16, and thus provide a better seal, as further described below.

[0072] Figure 3A Another stage in a mitral valve replacement procedure is depicted in which a user uses a prosthetic valve delivery device 60 to deliver and / or implant a prosthetic heart valve 62 (which may also be referred to herein as a "transcatheter heart valve" or simply "THV," a "replacement heart valve," and / or a "prosthetic mitral valve") within a docking device 52.

[0073] like Figure 3A , a prosthetic valve delivery device 60 may include a delivery shaft 64 and a handle 66, with the delivery shaft 64 extending distally from the handle 66. The delivery shaft 64 is configured to extend into the vasculature of a patient to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 is configured to be grasped and / or otherwise held by a user to advance the delivery shaft 64 through the vasculature of the patient.

[0074] In some examples, the handle 66 can include one or more articulating members 68 configured to facilitate guiding the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulating member 68 can include one or more of a knob, button, wheel, and / or other type of physically adjustable control member configured to be adjusted by a user to flex, bend, twist, rotate, and / or otherwise articulate the distal portion of the delivery shaft 64 to facilitate guiding the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and left ventricle 26 of the heart 14.

[0075] In some examples, the prosthetic valve delivery device 60 can include an expansion mechanism 65 configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. Figure 3A As shown, expansion mechanism 65 can include an inflatable balloon configured to radially expand prosthetic heart valve 62 within docking device 52 upon inflation.

[0076] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own when removed from a sheath or capsule that covers the radially compressed prosthetic heart valve 62 on the distal portion of the delivery shaft 64. In still other examples, the prosthetic heart valve 62 can be mechanically expandable, and the prosthetic valve delivery apparatus 60 can include one or more mechanical actuators (e.g., expansion mechanisms) configured to radially expand the prosthetic heart valve 62.

[0077] like Figure 3A As shown in FIG, a prosthetic heart valve 62 is mounted in a radially compressed configuration about an expansion mechanism 65 (an inflatable balloon) on a distal portion of a delivery shaft 64.

[0078] To guide the distal portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery device 60 (delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guidewire 40. The user can continue to advance the prosthetic valve delivery device 60 along the guidewire 40 (through the blood vessel 12) until the distal portion of the delivery shaft 64 reaches the native mitral valve 16, as shown. Figure 3A More specifically, a user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying force thereto (e.g., pushing the handle). As the delivery shaft 64 is advanced through the blood vessel 12 and the heart 14, the user can adjust one or more hinged members 68 of the handle 66 to navigate around various turns, corners, constrictions, and / or other obstacles in the blood vessel 12 and the heart 14.

[0079] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, such as Figure 3A As shown in , the distal end of the delivery shaft 64 and at least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26 .

[0080] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 ( Figure 3A ), a user can manipulate one or more actuators of the handle 66 of the prosthetic valve delivery device 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.

[0081] Figure 3B FIG. 5 shows another stage in a mitral valve replacement surgery in which a prosthetic heart valve 62 is in its radially expanded configuration and implanted within a docking device 52 in the native mitral valve 16. Figure 3B, the prosthetic heart valve 62 is received and retained within the docking device 52. Thus, the docking device 52 helps anchor the prosthetic heart valve 62 within the native mitral valve 16. The docking device 52 can achieve a better seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62.

[0082] Also like Figure 3B As shown in , after the prosthetic heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery apparatus 60 (including the delivery shaft 64) is removed from the patient 10, leaving only the guidewire 40 and the guide catheter 30 within the patient 10.

[0083] Figure 4 Another stage in the mitral valve replacement procedure is depicted, wherein the guidewire 40 and guide catheter 30 have been removed from the patient 10 .

[0084] although Figure 1-4 A mitral valve replacement procedure is specifically illustrated, but it should be understood that the same and / or similar procedures can be used to replace other heart valves (e.g., the tricuspid valve, the pulmonary valve, and / or the aortic valve). In addition, the same and / or similar delivery devices (e.g., docking device delivery device 50, prosthetic valve delivery device 60, guide catheter 30, and / or guidewire 40), docking devices (e.g., docking device 52), replacement heart valves (e.g., prosthetic heart valve 62), and / or components thereof can be used to replace these other heart valves.

[0085] For example, when replacing a native tricuspid valve, the user may also enter the right atrium 20 via the femoral vein, but may not need to enter the left atrium 18 through the atrial septum 22. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation procedure at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 ​​around the ventricular side of the tricuspid valve leaflet, release the remaining portion of the docking device 52 from the delivery shaft 54 ​​within the right atrium 20, and then remove the delivery shaft 54 ​​of the docking device delivery device 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar prosthetic heart valve implantation procedure at the tricuspid valve within the docking device 52. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery device 60 along the guidewire 40 through the patient's vasculature until the prosthetic heart valve 62 is positioned / disposed within the docking device 52 and the tricuspid valve. The user can then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery apparatus 60 from the patient 10. In another example, the user can perform the same and / or similar procedure to replace the aortic valve, but can access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0086] In addition, despite Figure 1-4 A mitral valve replacement procedure is depicted in which the native mitral valve 16 is accessed from the left atrium 18 via the right atrium 20 and the femoral vein, but it should be understood that the native mitral valve 16 can alternatively be accessed from the left ventricle 26. For example, a user can advance one or more delivery devices through the arteries to the aortic valve, through the aortic valve into the left ventricle 26, and then from the left ventricle 26 into the native mitral valve 16 via the aortic valve.

[0087] Figure 5 The docking device 52 is shown in more detail. Figure 5 As depicted in , the docking device 52 in its deployed configuration can be configured to receive and secure a prosthetic valve within the docking device, thereby securing the prosthetic valve at the native annulus.

[0088] The docking device 52 may include a coil 72 and an optional protective member 74 covering at least a portion of the coil 72. In some examples, the coil 72 may comprise a shape memory material (e.g., nickel titanium alloy or "nitinol") such that the docking device 52 (and the coil 72) may move from a substantially straight configuration (or delivery configuration) when disposed within the delivery shaft 54 ​​of the delivery apparatus 50 to a helical deployment configuration after removal from the delivery shaft 54.

[0089] The coil 72 has a proximal end 72p and a distal end 72d (which also define the proximal and distal ends of the docking device 52, respectively). When disposed within the delivery shaft 54 ​​(e.g., during delivery of the docking device 52 into the patient's vasculature), the body of the coil 72 between the proximal end 72p and the distal end 72d can form a generally straight delivery configuration (i.e., without any coiled or annular portions, but can be flexed or bent) so as to maintain a low radial profile while moving through the patient's vasculature. After being removed from the delivery shaft 54 ​​and deployed at the implantation site, the coil 72 can be moved from the delivery configuration to a helical deployment configuration and wrapped around native tissue adjacent to the implantation site. For example, when the docking device is implanted at the site of a native valve, the coil 72 can be configured to surround the native leaflets of the native valve (and the chordae tendineae connecting the native leaflets to the adjacent papillary muscles, if present).

[0090] The docking device 52 can be releasably coupled to the docking device delivery apparatus 50. For example, in some examples, the docking device 52 can be coupled to the delivery apparatus (as described above) via a release suture that can be configured to be tied to the docking device 52 and severed for removal.

[0091] like Figure 5As shown, the coil 72 in the deployed configuration may include a guide turn 76 (or "guide coil"), a central region 78, and a stabilizing turn 80 (or "stabilizing coil") around a central longitudinal axis. The central region 78 may have one or more helical turns having substantially equal inner diameters. In the example shown, the guide turn 76 may extend from a distal end of the central region 78 and have a diameter greater than the diameter of the central region 78. In the example shown, the stabilizing turn 80 may extend from a proximal end of the central region 78 and have a diameter greater than the diameter of the central region 78.

[0092] Further details of the docking device and variations thereof are described in International Application No. PCT / US2021 / 056150, which is incorporated herein by reference in its entirety.

[0093] Figure 6A A delivery device 200 is shown according to one example, which is configured to deliver, for example, a docking device 52 ( Figure 5 ) or other docking devices are implanted into the target implantation site in the patient's body. For example, the delivery device 200 can be used as a docking device delivery device 50 in a prosthetic valve implantation surgery, as described above with reference to Figure 2A The delivery device 200 may also be referred to as a "docking device delivery device," a "docking delivery catheter," or a "docking delivery system." As shown, the delivery device 200 can include a handle assembly 202 and a delivery shaft 204 (also referred to as a "delivery sheath" or "outer shaft" or "outer sheath") extending distally from the handle assembly 202. The handle assembly 202 can include a first or main handle 206 that includes one or more knobs, buttons, wheels, and / or other devices for controlling and / or actuating one or more components of the delivery device 200. For example, in some examples, such as Figure 6A As shown in FIG, the main handle 206 can include knobs 208 and 210 that can be configured to manipulate or control the deflection of the delivery device 200, such as the delivery shaft 204 and / or cannula 220 described below.

[0094] In some examples, the delivery apparatus 200 may further include a pusher shaft 212 and a cannula shaft 220 , both of which may extend through the interior lumen of the delivery shaft 204 and have respective proximal end portions extending into the handle assembly 202 .

[0095] As described below, the distal end portion (also referred to as the "distal section") of the cannula shaft 220 can be configured to cover (eg, surround) the docking device 52 (see Figure 5For example, the distal portion of the cannula shaft 220 can comprise a generally tubular structure. For example, the docking device 52 can be retained within the cannula shaft 220, which is further retained by the distal portion 205 of the delivery shaft 204 while being guided through the patient's vasculature.

[0096] Additionally, the distal portion 205 of the delivery shaft 204 can be configured to be steerable. In one example, by rotating a knob (e.g., 208 or 210) on the main handle 206, the curvature of the distal portion 205 can be adjusted so that the distal portion 205 of the delivery shaft 204 can be oriented at a desired angle. For example, to implant the docking device 52 at the native mitral valve site, the distal portion 205 of the delivery shaft 204 can be steered within the left atrium so that the cannula shaft 220 and at least a portion of the docking device 52 retained therein can extend through the native mitral valve annulus at a location adjacent to the posteromedial commissure.

[0097] In some examples, the pusher shaft 212 and the cannula shaft 220 can be coaxial with each other at least within the delivery shaft 204. Additionally, the delivery shaft 204 can be configured to be axially movable relative to the cannula shaft 220 and the pusher shaft 212. As described further below, the distal end of the pusher shaft 212 can be inserted into the lumen of the cannula shaft 220 and pressed against the proximal end of the docking device 52 held within the interior of the cannula shaft 220.

[0098] After reaching the target implantation site, the docking device 52 can be deployed from the delivery shaft 204 by manipulating the pusher shaft 212 and the cannula shaft 220 using the docking handle 218 (also referred to as the "second handle" or "hub assembly"), as further described below. For example, by pushing the pusher shaft 212 in the distal direction while holding the delivery shaft 204 in place, or retracting the delivery shaft 204 in the proximal direction while holding the pusher shaft 212 in place, or retracting the delivery shaft 204 in the proximal direction while pushing the pusher shaft 212 in the distal direction, the docking device 52 can be pushed out of the distal end 204d of the delivery shaft 204, thereby allowing the docking device 52 to transition from the delivery configuration to the deployed configuration (see Figure 5 In some examples, the pusher shaft 212 and the quill shaft 220 can be actuated independently of each other.

[0099] During delivery, the docking device 52 can be released via a release suture 222 extending through the pusher shaft 212 (see Figure 6B ) or other retrieval line including a rope, yarn, or other material that can be configured to be looped around the docking device 52 and cut for removal is coupled to the delivery device 200. In one particular example, the release suture 222 can extend through the delivery device 200, for example, through the interior lumen of the pusher shaft 212, to the suture lock assembly 216 of the delivery device 200.

[0100] The handle assembly 202 may also include one or more irrigation ports (e.g., Figure 6A The flush port 232 is shown in FIG. Figures 6A-6B ), to supply irrigation fluid to one or more lumens disposed within the delivery device 200 (eg, an annular lumen disposed between coaxial components of the delivery device 200), for example, to maintain hemostasis within the delivery device 200.

[0101] Further details regarding delivery devices / catheters / systems (including various examples of handle assemblies) configured to deliver a docking device to a target implantation site can be found in International Application No. PCT / US2020 / 036577 and U.S. Patent Publication Nos. 2018 / 0318079 and 2018 / 0263764, each of which is incorporated herein by reference in its entirety.

[0102] As described above, the handle assembly 202 may also include a docking handle 218 to which the suture lock assembly 216 and the cannula handle 224 are attached. The docking handle 218 may be configured to independently control the pusher shaft 212 and the cannula shaft 220. The cannula handle 224 is coupled to the proximal end of the cannula shaft 220 and may control the axial position of the cannula shaft 220 relative to the pusher shaft 212. In this way, the operation of the various components of the handle assembly 202 may actuate and control the operation of the components disposed within the delivery shaft 204. In some examples, the docking handle 218 may be coupled to the main handle 206 via a connector 226.

[0103] Figure 6B An example of a docking handle 218 of the handle assembly 202 is shown in greater detail. In some examples, as shown, the docking handle 218 can include a Y-shaped connector 228 (also referred to as an "adapter") having a straight section 230 (e.g., a straight conduit) and at least one branch 236 (e.g., a branched conduit), although in some examples, the Y-shaped connector can include more than one branch.

[0104] The docking handle 218 can be adapted and configured to allow the proximal section 238 of the pusher shaft 212 (or another similar pusher shaft) to extend to the suture lock assembly 216 disposed at the end of the branch 236, while the proximal portion 240 of the cannula shaft 220 extends to the cannula handle 224 disposed at the proximal end of the straight section 230 (see FIG. Figure 7 With this configuration, a medical professional can perform a docking operation (eg, Figure 5 52 ), and also performs retraction of the cannula shaft 220 (away from and away from the implanted docking device) by pulling back the cannula handle 224 in the axial direction.

[0105] In this way, the cannula shaft 220 and the pusher shaft 212 can be configured to work together so that they can move together simultaneously when deploying and positioning the docking device at the native valve (e.g., by moving the entire docking handle 218 forward and / or rearward in the axial direction), but can also move independently so that the pusher shaft 212 can hold the docking device in place while the cannula shaft 220 is retracted from the docking device (e.g., by holding the docking handle 218 in place relative to the outer shaft 204 of the delivery device 200 and / or other portions of the delivery device 200 and / or the docking device while pulling the cannula handle 224 proximally, thereby withdrawing the cannula shaft 220).

[0106] like Figure 7 As shown in FIG, the proximal portion 240 of the cannula 220 has an outer surface 242 including an inwardly facing surface 244 and an outwardly facing surface 246. The inwardly facing surface 244 can define an open channel. For example, the channel of the cannula 220 is open in the radial direction so that the proximal segment 238 of the pusher shaft 212 can be moved relative to the longitudinal axis 225 ( Figure 23 ) extends out of the open channel at an angle and away from the cannula shaft 220 (eg, via branch 236). In some examples, the proximal portion 240 of the cannula shaft 220 may also be referred to herein as the "open channel 240."

[0107] like Figure 7 , the open channel 240 may have a generally U-shaped or C-shaped cross-section. In some examples, as depicted, the outer surface 242 is curved such that the open channel 240 has a partially annular cross-section (e.g., a C-shaped cross-section). Specifically, the open channel 240 may be partially annular such that the inwardly facing surface 244 is a concave surface and the outwardly facing surface 246 is a convex surface. The edge surface or edge 248 may define the junction between the concave (or inwardly facing) surface 244 and the convex (or outwardly facing) surface 246. In this way, the inwardly facing surface 244 of the open channel 240 may form a void space in which the pusher shaft 212 may be at least partially disposed ( Figure 7 In various examples, a laser can be used to cut the open channel 240 (eg, to form the edge 248, etc.), although any other means for forming the open channel (eg, removing a portion of the tubular structure) can be used.

[0108] The distal section 250 of the cannula shaft 220 may include a closed passage or lumen such that the passage is closed in a radial direction (eg, annular in cross-section). Figure 6A). The pusher shaft 212 can extend through the closed channel of the distal segment 250. For example, the pusher shaft 212 can be coaxial with the cannula shaft 220 along some or a majority of the delivery device 200, such as through the distal segment 250 of the cannula shaft 220. The distal segment 250 can extend from the distal end of the cannula shaft 220 to the open channel 240, for example, at an intermediate axial position of the cannula shaft 220. The open channel 240 of the cannula shaft 220 can extend from the intermediate axial position of the cannula shaft 220 to the proximal end of the cannula shaft 220, such as to the cannula handle 224. In other examples, the open channel 240 of the cannula shaft 220 can extend proximally from the intermediate axial position, rather than extending to the proximal end of the cannula shaft 220. In these examples, the open channel 240 can form an axially extending window or slot that allows the proximal segment 238 of the pusher shaft 212 to extend out from the cannula shaft 220 at a certain angle.

[0109] The docking handle 218 may include, for example, a sealing housing 252 disposed at a proximal portion of the straight section 230. In some examples, the housing of the docking handle 218 may include the sealing housing 252, or define a portion of the sealing housing 252. In some examples, such as Figure 15 As depicted, the seal housing 252 can be formed separately from the housing of the docking handle 218 and coupled thereto.

[0110] The seal housing 252 may house various gaskets, seals, and / or washers to form a seal around the open passage 240 of the quill 220. For example, Figure 8 and 9 24 shows an example of a hemostatic seal 2400 that can be disposed within the seal housing 252 and used to seal around the open channel 240 of the cannula shaft 220. In some examples, such as Figures 6A-6B , the locking knob 254 can be coupled to the seal housing 252, for example, via a threaded connection. The locking knob 254 can be transitioned between an active or locked configuration and an inactive or unlocked configuration. In the locked configuration, the locking knob 254 can be configured to lock the cannula 220, preventing the cannula 220 from moving relative to the docking handle 218, and to apply sufficient pressure to the hemostatic seal 2400 to actively seal the open channel 240 of the cannula 220. In the unlocked configuration, this pressure is removed from the hemostatic seal 2400, allowing the cannula 220 to move relative to the docking handle 218. In some cases, in the unlocked configuration, the seal 2400 may not actively seal the cannula 220 and / or provide hemostasis. In this manner, the hemostatic seal 2400 can be considered an active seal.

[0111] like Figure 8As seen in FIG, the hemostatic seal 2400 can have an opening 2406 in the shape of a cross section of the open channel 240 of the cannula shaft 220, such as a U-shape or a C-shape or an incomplete (e.g., partial) annular shape, configured to receive the open channel 240 therein and seal on all sides of the cannula shaft 220 (e.g., surfaces 244, 246 and edge 248). Figure 9 An example of a hemostatic seal 2400 is shown disposed within a portion of a seal housing 252. Figure 9 In FIG. 2 , the seal 2400 and a portion of the seal housing 252 are transparent, and the locking knob 254 is omitted for illustration purposes. Figure 9 , two rigid washers 2402 and 2404 can support each end of the hemostatic seal 2400. The rigid washers 2402, 2404 can have the same profile as the hemostatic seal 2400 to maintain the integrity of the hemostatic seal 2400. In the locked configuration, the rigid washers 2402, 2404 can apply inward pressure to the hemostatic seal 2400 to ensure a seal between the hemostatic seal 2400 and the open channel 240 of the cannula shaft 220 based on the contact between the locking knob 254 and the proximal washer 2402.

[0112] In some examples, it may be desirable for the cannula 220 to be sealed independently of the locked state of the cannula 220. For example, rather than a seal that selectively functions (e.g., actively seals in a locked configuration), it may be desirable for the cannula 220 to be sealed by a passive seal that is capable of achieving a hemostatic seal around the cannula 220 while the cannula 220 is free to move relative to the handle assembly 202. In other words, a passive hemostatic seal may exist around the cannula 220 regardless of whether the cannula 220 is locked or unlocked. In these examples, a locking mechanism may be used to secure the cannula 220 relative to the handle assembly 202, which operates independently of the hemostatic seal of the cannula 220. For example, the locking mechanism may include a structure other than the locking knob 254, such as a collet, clamp, etc., that is configured to apply frictional and / or compressive forces to the cannula 220 to prevent movement of the cannula 220 relative to the handle assembly 202. In some examples, the locking mechanism can be spaced apart from and / or proximal to the seal of the cannula 220. Additional examples of locking mechanisms are described in US Provisional Patent Application No. (Attorney Docket No. THVDL-13027US01), which is incorporated herein by reference in its entirety.

[0113] Figure 10-15An example of a hemostatic seal 100 is shown that passively seals an open channel 240 of a cannula shaft 220 and can be disposed within a seal housing 252. For example, the seal 100 can provide hemostasis during relative movement between the cannula shaft 220 and the seal 100. The passive hemostatic seal 100 can provide sufficient sealing force to the cannula shaft 220, for example, based on a compressive force applied to the seal 100 (e.g., by the seal housing 252, etc.) and independent of a locking mechanism of the cannula shaft 220.

[0114] As shown, the hemostatic seal 100 includes a plurality of sealing members to seal around an open channel 240 within a seal housing 252. Specifically, the hemostatic seal 100 includes a first (or outer) sealing member 102 coupled to an outer sealing member 102 and a second (or inner) sealing member 104. The outer sealing member 102 and the inner sealing member 104 are coupled together to form a seal therebetween. The outer sealing member 102 can be configured to seal around at least an outward-facing surface 246 of the open channel 240. For example, the outer sealing member 102 can seal a first gap between the outward-facing surface 246 and an inner wall 256 of the seal housing 252. The inner sealing member 104 can be configured to seal against at least an inward-facing surface 244 of the open channel 240. For example, the inner sealing member 104 can seal a second gap between the inward-facing surface 244 and an inner wall 256 of the seal housing 252.

[0115] In some cases, the sealed housing 252 may be integrally formed as a single, unitary component. Figure 10 14-15, the sealed housing 252 may include one or more segments formed as separate components that are coupled together (e.g., via fasteners, adhesives, mating features, and / or other means for coupling). For example, the sealed housing 252 may include a plurality of segments that are coupled together (e.g., via fasteners, adhesives, mating features, and / or other means for coupling) via mating features (e.g., pin 260 and socket connection). Figure 15 )) are coupled together with a first or upper segment 252a and a second or lower segment 252b. In other examples, such as Figure 16-17 , the seal housing 252 may include a distal segment 252d and a proximal segment 252p (eg, instead of the upper segment 252a and the lower segment 252b). In some examples, the seal housing 252 may be manufactured using one or more molding processes (eg, injection molding, etc.).

[0116] The inner wall 256 can at least partially define a chamber in which the hemostatic seal 100 can be disposed. When the hemostatic seal 100 is disposed within the chamber of the seal housing 252 and around the cannula shaft 220, the hemostatic seal 100 creates a passive hemostatic seal around the cannula shaft 220. For example, the seal housing 252 can provide sufficient compression to the hemostatic seal 100 such that the open passage 240 of the cannula shaft 220 is sealed while the cannula shaft 220 is free to move relative to the docking handle 218. In addition to the inner wall 256, the chamber of the seal housing 252 can also be defined by one or more inner surfaces of the seal housing 252, including a distal surface 262 and a proximal surface 264 ( Figure 10 As shown, the hemostatic seal 100 can be positioned between the distal surface 262 and the proximal surface 264 and compressed within the chamber of the seal housing 252 (e.g., by the inner wall 256, by the wedge 258, and / or by the distal surface 262 and the proximal surface 264). In this manner, the hemostatic seal 100 creates a passive hemostatic seal around the cannula shaft 220, including when the cannula shaft 220 moves relative to the seal 100, the seal housing 252, and / or the docking handle 218 (e.g., independent of the locked or unlocked state of the cannula shaft 220).

[0117] The outer sealing member 102 includes an inner surface 106 that defines an opening 108 extending through the sealing member 102. The opening 108 extends from the first end 110 to the second end 112 of the sealing member 102, and the quill 220 can extend through the opening 108. In some examples, as depicted, the inner surface 106 can include a first or flat portion 106a and a second or curved portion 106b ( Figure 13A ), such that the opening 108 is D-shaped. As shown, the second portion 106b can generally correspond to and complement the shape of the outward-facing surface 246. For example, the second portion 106b can be an inward-facing surface (e.g., having a concave curvature, etc.). When the outer sealing member 102 is positioned about the quill 220, the second portion 106b can contact the outward-facing surface 246 of the open channel 240 and have the same or substantially the same radius of curvature as the outward-facing surface 246. In this manner, when the quill 220 is positioned within the opening 108, the curved portion 106b can seal against and / or around the outward-facing surface 246. In some examples, the flat portion 106a can contact and seal against and / or around the edge 248 of the open channel 240. Thus, the outer sealing member 102 can create a seal around the outer surface of the open channel 240 (e.g., the outward-facing surface 246 and, in some examples, the edge 248). In other examples, the inner surface 106 may define openings having other shapes that engage at least the outwardly facing surface 246 of the quill 220 , including circular openings, square or rectangular openings (eg, for a u-shaped quill 220 ), etc.

[0118] In some examples, the outer seal member 102 is generally cylindrical with a stepped outer surface 114. The outer surface 114 can include a first outer surface portion 114a adjacent the first end 110 and a second outer surface portion 114b adjacent the second end 112. The outer diameter of the first outer surface portion 114a can be sized to fit within the chamber of the seal housing 252 such that the outer seal member 102 contacts the inner wall 256 of both the upper segment 252a and the lower segment 252b. In this manner, the first outer surface portion 114a can seal a first gap between the inner wall 256 of the seal housing 252 and the outward-facing surface 246 of the quill 220.

[0119] The outer diameter of the second outer surface portion 114b can be smaller than the outer diameter of the first outer surface portion 114a. Specifically, the outer surface 114 of the outer sealing member 102 includes a shoulder 116 axially defining a transition between the first and second outer surface portions 114a, 114b between the first and second ends 110, 112.

[0120] Inner seal member 104 includes an inner surface 118 defining an opening 120 through which quill 220 can extend. In some examples, inner surface 118 can be stepped and have a first inner surface portion 118a adjacent to a first end 122 of inner seal member 104 and a second inner surface portion 118b adjacent to a second end 124 of inner seal member 104. The inner diameter of first inner surface portion 118a can be sized to receive second outer surface portion 114b of outer seal member 102, such that first inner surface portion 118a of inner seal member 104 contacts second outer surface portion 114b of outer seal member 102 when seal members 102, 104 are coupled together. In some examples, first inner surface portion 118a can define a larger opening than second inner surface portion 118b. For example, the radius of curvature of second inner surface portion 118b can be smaller than the radius of curvature of first inner surface portion 118a. In the example shown, the radius of curvature of the second inner surface portion 118b can be equal to or approximately equal to the radius of curvature of the outwardly facing surface 246 of the open channel 240. The inner surface 118 of the inner sealing member 104 can include a lip 126 positioned axially between the first end 122 and the second end 124, the lip defining a transition between the first inner surface portion 118a and the second inner surface portion 118b.

[0121] As described above, the outer sealing member 102 and the inner sealing member 104 can be coupled or mated together so that a seal is formed between the sealing members 102, 104. For example, the sealing members 102, 104 can partially overlap in the radial and axial directions. In some examples, as shown, the inner sealing member 104 can be disposed partially around the outer sealing member 102. The inner sealing member 104 can include an extension 128 that protrudes axially outward at the first end 122 of the inner sealing member 104 and extends above the outer sealing member 102. The extension 128 can surround the second outer surface portion 114b of the outer sealing member 102 and abut the shoulder 116. Specifically, when the outer sealing member 102 and the inner sealing member 104 are mated together, the first inner surface portion 118a (the inner surface of the extension 128) can contact the second outer surface portion 114b. Figure 12B As shown in FIG, the extension 128 and the first inner surface portion 118 a have a shape corresponding to the second outer surface portion 114 b of the sealing member 102 (eg, annular).

[0122] The second end 112 of the outer seal member 102 can contact the lip 126 and / or the inner protrusion 130 of the inner seal member 104. In some examples, as depicted, the lip 126 and the inner protrusion 130 can define a first intermediate surface 132 ( Figure 12B ), which is parallel to the first end 122 of the inner seal member 104. The first intermediate surface 132 is axially disposed between the first end 122 and the second end 124 of the inner seal member 104. When the outer and inner seal members 102, 104 are mated together, the second end 112 of the outer seal member 102 may contact the first intermediate surface 132, and the first end 122 of the inner seal member 104 may contact the shoulder 116 of the outer seal member 102. For example, the axial distance between the first intermediate surface 132 and the first end 122 of the inner seal member 104 may be equal to the axial distance between the shoulder 116 and the second end 112 of the outer seal member 102. In other words, the first inner surface portion 118a of the inner seal member 104 and the second outer surface portion 114b of the outer seal member 102 may have the same length.

[0123] The lip 126 can define a step along the inner surface 118 of the inner seal member 104. In this manner, when the cannula shaft 220 is disposed within the hemostatic seal 100, the first inner surface portion 118a can contact the second outer surface portion 114b of the outer seal member 102, and the second inner surface portion 118b can contact the outwardly facing surface 246 of the open channel 240. In some examples, the height of the lip 126 can be smaller (e.g., less than Figure 10), or lip 126 may be omitted such that a portion of the inner surface of inner seal member 104 does not contact quill 220 (e.g., relying on outer seal member 102 to seal the gap between seal housing 252 and outwardly facing surface 246 of quill 220).

[0124] In some examples, the sealing members 102, 104 can be fitted together in other ways and / or using structures other than the shoulder 116 and the extension 128. For example, rather than the outer sealing member 102 having a reduced outer diameter being fitted within the inner sealing member 104, the inner sealing member 104 can be configured to fit within the opening 108 of the outer sealing member 102. Specifically, the outer surface 114 of the outer sealing member 102 can have a continuous outer diameter, and the inner surface 106 defining the opening 108 can be stepped so that the extension of the inner sealing member 104 can be disposed within the opening 108 and abut a shoulder or lip therein. Thus, in some examples, the outer sealing member 102 can be disposed partially around the inner sealing member 104.

[0125] In some examples, as shown, the first end 110 of the outer seal member 102 can contact the distal surface 262 of the seal housing 252, and the second end 124 of the inner seal member 104 can contact the proximal surface 264 of the seal housing 252. In other examples, the hemostasis seal 100 can be oriented differently such that the first end 110 of the outer seal member 102 can contact the proximal surface 264, and the second end 124 of the inner seal member 104 can contact the distal surface 262.

[0126] Seal members 102, 104 may have a lower durometer hardness than seal housing 252 and cannula shaft 220. For example, seal members 102, 104 may be relatively softer and / or more flexible than seal housing 252 and cannula shaft 220 such that seal members 102, 104 may be compressed against an inner surface of seal housing 252 and around a surface of cannula shaft 220 to form a hemostatic seal around cannula shaft 220 within seal housing 252.

[0127] The inner protrusion 130 of the inner seal member 104 can be configured to seal against the inward-facing surface 244 of the open channel 240. For example, the inner protrusion 130 can extend into the opening 120 of the inner seal member 104 in a direction perpendicular to the longitudinal axis of the inner seal member 104 (and perpendicular to the longitudinal axis 225 of the quill 220). When the quill 220 is positioned within the opening 120, the engagement surface 134 of the inner protrusion 130 can contact the inward-facing surface 244 of the open channel 240. As shown, the engagement surface 134 can generally correspond to and complement the shape of the inward-facing surface 244. For example, the engagement surface 134 can have an outward-facing surface (e.g., a convex curvature, etc.). In this manner, the inner protrusion 130 can extend or protrude into the opening defined by the open channel 240, and the engagement surface 134 can seal against the inward-facing surface 244.

[0128] To ensure an adequate seal between the engagement surface 134 of the inner protrusion 130 and the inward-facing surface 244 of the quill 220, the inner protrusion 130 or a portion thereof can include a different material than the remainder of the inner seal member 104 and / or the outer seal member 102. In some examples, the material can be harder and / or more rigid to enhance the structural integrity of the inner protrusion. In some examples, the material can be a material with a lower durometer hardness (e.g., more compressible) to provide better sealing capabilities.

[0129] In some examples, to ensure an adequate seal between the engagement surface 134 of the inner protrusion 130 and the inward-facing surface 244 of the quill 220, a more rigid component may be positioned at least partially within the inner protrusion 130. For example, a relatively hard or rigid component may enhance the structural integrity of the inner protrusion 130 so that the inner protrusion 130 applies an adequate sealing force against the inward-facing surface 244. In some examples, a separate structure or component may be disposed within an opening or slot in the inner protrusion 130.

[0130] To accommodate relatively rigid components, the inner protrusion 130 may include a groove 136 extending along the axial length of the inner protrusion 130. For example, the groove 136 may extend from the second end 124 to a second intermediate surface 138 (axially disposed between the first end 122 and the second end 124 of the inner seal member 104). Figure 11 and 13B As shown, the second intermediate surface 138 is located at or near the lip 126 .

[0131] In some examples, at least a portion of the seal housing 252 may extend or protrude radially inward from the inner wall 256. When the inner seal member 104 is positioned within the seal housing 252, this portion of the seal housing 252 may extend into the groove 136. For example, the seal housing 252 may include a protrusion or wedge 258 that is configured to extend into the groove 136 and ensure that the inner seal member 104 contacts and / or expands against the inward-facing surface 244 of the open channel 240. Before the wedge 258 is positioned within the groove 136, the components (e.g., the quill 220) can move freely relative to the seal 100, which can provide advantages during the assembly process. After the components are positioned relative to the seal 100, the seal 100 can be activated by positioning the wedge 258 within the groove 136 (e.g., at the end of the assembly process). Figure 10 As shown in FIG, the upper segment 252a may include a wedge 258 (see also FIG. Figure 15 In other examples, other segments of the seal housing 252 (eg, the distal segment 252 d of the seal housing 252 , etc.) may include the wedge 258 .

[0132] As shown in FIG. 1 , an end view of the inner sealing member 104 is shown. Figure 13B , the inner protrusion 130 defines two openings extending axially through the inner seal member 104. The open channel 240 can extend through the lower opening 120, and the wedge 258 can extend radially into the upper opening 121 defined by the groove 136. Specifically, when the inner seal member 104 is disposed within the seal housing 252, the wedge 258 is positioned with the upper opening 121 and contacts the groove 136. In this way, the wedge 258 can be configured to hold the inner protrusion 130 in place relative to the seal housing 252 to ensure a seal between the engagement surface 134 of the inner protrusion 130 and the inwardly facing surface 244 of the open channel 240. In some examples, the shape of the groove 136 can correspond to the shape of the wedge 258 (e.g., having a constant width; see Figure 11 、 12B ). In other examples, such as Figure 13B and 14 , the groove 136 can be tapered or stepped such that the groove 136 is wider at a location closer to the outer surface of the inner seal member 104 and narrower toward the lower end of the groove 136. In these examples, the wedge 258 can extend or expand the narrow portion of the groove 136 radially outward against the inwardly facing surface 244 of the open channel 240.

[0133] Groove 136 is shown as an axially through-groove, such that first intermediate surface 132 and second end 124 of inner seal member 104 define an open end of groove 136. In some examples, rather than being a through-groove having opening 121 extending through first intermediate surface 132 and second end 124, groove 136 may extend less than the entire axial length of inner protrusion 130. For example, the ends of groove 136 may be spaced apart from first intermediate surface 132 and / or second end 124 of inner seal member 104, such that groove 136 is open only in a radial direction through the outer surface of inner seal member 104.

[0134] The inner protrusion 130 can also be configured to seal against the edge 248 of the open passage 240. For example, the inner protrusion 130 can include flat axially extending surfaces 140, 142 disposed on either side of the engagement surface 134 that seal against the edge 248. The second inner surface portion 118b, the engagement surface 134, and the surfaces 140, 142 can define the opening 120 at the second end 124 of the inner seal member 104. At the first end 122 of the inner seal member 104, the opening 120 is defined by the first inner surface portion 118a. In this manner, the opening 120 has a different shape at the first end 122 of the inner seal member 104 (e.g., corresponding to the shape of the second end 112 of the outer seal member 102) than at the second end 124 of the inner seal member 104 (e.g., corresponding to the shape of the open passage 240 of the quill 220).

[0135] In some examples, a passive hemostatic seal may include one sealing member rather than multiple sealing members. Figure 16-20 An example of a hemostatic seal 300 is shown that passively seals the open channel 240 of the cannula shaft 220 and can be disposed within a seal housing 252. As shown, the hemostatic seal 300 includes a sealing member 302 that seals around the open channel 240 and a sealing block 304 coupled to the sealing member 302. The sealing member 302 can be configured to seal the open channel 240 within a chamber of the seal housing 252 (e.g., between the open channel 240 and the inner wall 256). The sealing block 304 can be configured, for example, similar to the wedge 258 of the seal housing 252, to expand and / or compress a portion of the sealing member 302 against at least the inward-facing surface 244 of the open channel 240.

[0136] In some examples, the sealing block 304 may be used instead of and / or in addition to the wedge 258. For example, Figure 16-17, the seal housing 252 does not include the wedge 258. As described above, in some examples, the seal housing 252 may include a first or distal segment 252d and a second or proximal segment 252p coupled to the first segment 252d. For example, the second segment 252p may be a cover that fits around the proximal end of the first segment 252d and is secured thereto. In the example shown, the first segment 252d includes a distal surface 262 and an inner wall 256, and the second segment 252p includes a proximal surface 264.

[0137] As shown, the hemostatic seal 300 can be positioned between the distal surface 262 and the proximal surface 264 and compressed within the chamber of the seal housing 252 (e.g., by the inner wall 256 and / or by the distal surface 262 and the proximal surface 264). In this manner, the hemostatic seal 300 creates a passive hemostatic seal around the cannula shaft 220, including when the cannula shaft 220 moves relative to the seal 300, the seal housing 252, and / or the docking handle 218 (e.g., independent of the locked or unlocked state of the cannula shaft 220). Although the hemostatic seal 300 is shown as being positioned within a seal housing 252 having a distal segment and a proximal segment, the hemostatic seal 300 can be disposed within any seal housing (e.g., any of the seal housings described herein, a seal housing having an upper segment and a lower segment, etc.).

[0138] Figure 16 A cross-sectional view of the hemostatic seal 300 disposed within a chamber of the seal housing 252 is shown. Figure 17 The hemostatic seal 300 is shown within the seal housing 252 with the second section 252p removed for illustrative purposes. Figures 18A-18D Various views of the sealing member 302 are shown. Figure 19-20 A hemostatic seal 300 is shown disposed about the open channel 240 of the cannula shaft 220 .

[0139] The sealing member 302 is generally cylindrical and includes a first or outer sealing portion 306 and a second or inner sealing portion 308. The outer sealing portion 306 is adjacent to a first end 310 of the sealing member 302 and is configured to seal around and / or against at least the outward-facing surface 246 of the open passage 240. For example, the outer sealing portion 306 can seal a first gap between the outward-facing surface 246 and the inner wall 256 of the seal housing 252. The inner sealing portion 308 is adjacent to a second end 312 of the sealing member 302 and is configured to seal around and / or against at least the inward-facing surface 244 of the open passage 240. For example, the inner sealing portion 308 can seal a second gap between the inward-facing surface 244 and the inner wall 256 of the seal housing 252.

[0140] like Figures 18A-18DAs shown in FIG, the outer seal portion 306 includes an inner surface 314 defining an opening 316 that extends through the outer seal portion 306 from the first end 310 to a first intermediate surface 318 positioned axially between the first end 310 and the second end 312. As shown, the first intermediate surface 318 is parallel to the surface of the first end 310 of the seal member 302 (e.g., perpendicular to the longitudinal axis of the seal member 302). In some examples, as depicted, the inner surface 314 may include a first flat portion 314a and a second or curved portion 314b (see FIG. Figure 18B ), such that the opening 108 is D-shaped. As shown, the second portion 314b can generally correspond to and complement the shape of the outward-facing surface 246. For example, the second portion 314b can be an inward-facing surface (e.g., having a concave curvature, etc.). When the sealing member 302 is positioned about the quill 220, the curved portion 314b can contact the outward-facing surface 246 of the open channel 240 and have the same or substantially the same radius of curvature as the outward-facing surface 246. In this manner, when the quill 220 is positioned within the opening 316, the curved portion 314b can seal against and / or around the outward-facing surface 246. In some examples, the flat portion 314a can contact and seal against and / or around the edge 248 of the open channel 240. Thus, the outer sealing portion 306 can create a seal around the outer surface of the open channel 240 (e.g., the outward-facing surface 246 and, in some examples, the edge 248). In other examples, the inner surface 314 may define openings having other shapes that engage at least the outward-facing surface 246 of the quill 220 , including circular openings, square or rectangular openings (eg, for a u-shaped quill 220 ), etc.

[0141] In some examples, the seal member 302 is generally cylindrical. For example, the outer diameter of the outer seal portion 306 can be sized to fit within the chamber of the seal housing 252 such that the outer surface of the outer seal portion 306 contacts the inner wall 256 of the seal housing 252. In some examples, as shown, the outer seal portion 306 contacts the inner wall 256 within the distal segment 252d and contacts the proximal surface 264 within the proximal segment 252p. In this way, the outer seal portion 306 can seal a first gap between the inner wall 256 of the seal housing 252 and the outward-facing surface 246 of the cannula 220.

[0142] In some examples, such as Figure 16, a first end 310 of the seal member 302 can contact the proximal surface 264 of the seal housing 252, and a second end 312 of the seal member 302 can be positioned toward the distal surface 262 of the seal housing 252. The seal block 304 can contact the distal surface 262. In other examples, the hemostasis seal 300 can be oriented differently such that the first end 310 of the seal member 302 can contact the distal surface 262, and the second end 312 of the seal member 302 can be positioned toward the proximal surface 264. The seal block 304 can contact the proximal surface 264.

[0143] Seal member 302 can have a lower durometer hardness than seal housing 252, cannula shaft 220, and seal block 304. For example, seal member 302 can be relatively softer and / or more flexible than seal housing 252, cannula shaft 220, and seal block 304, such that seal block 304 can compress at least a portion of seal member 302 against a surface of cannula shaft 220, and seal member 302 can be compressed against an inner surface of seal housing 252 and around a surface of cannula shaft 220 to create a hemostatic seal around cannula shaft 220 within seal housing 252.

[0144] The inner sealing portion 308 may include an inner protrusion 330 configured to seal against the inward-facing surface 244 of the open channel 240. For example, the inner protrusion 330 may extend radially inward from the outer surface of the sealing member 302, for example, in a direction perpendicular to the longitudinal axis of the sealing member 302 (and perpendicular to the longitudinal axis 225 of the cannula shaft 220). The inner protrusion 330 extends axially along the length of the inner sealing portion 308. When the hemostasis seal 300 is coupled to the cannula shaft 220, the inner protrusion 330 extends axially along the length of the open channel 240. In this manner, the inner protrusion 330 may form a flap or tongue that can be compressed against the inward-facing surface 244 of the open channel 240. Specifically, when the cannula shaft 220 is positioned within the opening 316 of the sealing member 302, the engagement surface 334 of the inner protrusion 330 may contact the inward-facing surface 244 of the open channel 240. As shown, the engagement surface 334 can generally correspond to and complement the shape of the inward-facing surface 244. For example, the engagement surface 334 can have an outward-facing surface (e.g., a convex curvature, etc.). In this manner, the inner protrusion 330 can extend or protrude into the opening defined by the open channel 240, and the engagement surface 334 can seal against the inward-facing surface 244.

[0145] The inner sealing portion 308 can also be configured to seal against the edge 248 of the open channel 240. For example, the inner sealing portion 308 can include flat axially extending surfaces 322 disposed on either side of the inner protrusion 330 that seal against the edge 248.

[0146] To ensure an adequate seal between the engagement surface 334 of the inner protrusion 330 and the inward-facing surface 244 of the quill 220, a more rigid component may be positioned at least partially within the inner protrusion 330. For example, the relatively rigid component may enhance the structural integrity of the inner protrusion 330, allowing the inner protrusion 330 to exert an adequate sealing force against the inward-facing surface 244. In some cases, the inner protrusion 330, or a portion thereof, may comprise a different material (e.g., harder, more rigid, etc.) than the remainder of the sealing member 302. In some examples, a separate structure or component may be disposed within an opening or slot in the inner protrusion 330.

[0147] To accommodate relatively rigid components, the inner protrusion 330 may include a groove 336 extending along a portion of the axial length of the inner protrusion 330. For example, the groove 336 may extend from the second end 312 to a second intermediate surface 338 (axially disposed between the first end 310 and the second end 312 of the sealing member 302). Figure 18B As shown, the second intermediate surface 338 is axially spaced apart from the first intermediate surface 318 . In other examples, the second intermediate surface 338 may be axially aligned with the first intermediate surface 318 .

[0148] As described above, in some examples, a portion of the seal housing 252 (e.g., the wedge 258) can extend into the groove 336. In some examples, a portion of the seal housing 252 and a portion of the seal block 304 can both extend into the groove 336. In other examples, such as Figure 16 and 19 As depicted in FIG-20 , a portion of the sealing block 304 can extend into the groove 336 instead of into the seal housing 252. When the sealing block 304 is coupled to the sealing member 302, this portion of the sealing block 304 can extend into the groove 336. For example, the sealing block 304 can include a protrusion or wedge 358 that is configured to extend into the groove 336 and can ensure that the engagement surface 334 of the inner protrusion 330 contacts and / or expands against the inward-facing surface 244 of the open channel 240.

[0149] like Figure 19 and 20As shown in FIG, the sealing block 304 may include a first portion 340 at a first end 342 of the sealing block 304, the first end contacting the second intermediate surface 338 of the sealing member 302. The sealing block 304 may include a second portion 344 at a second end 346 of the sealing block 304. The second portion 344 may include an inner surface 348 that may define an opening 350. The open channel 240 may extend through the opening 350. For example, the shape of the opening 350 may correspond to the cross-sectional shape of the open channel 240, such as a C-shaped or U-shaped opening, and / or other shapes into which the open channel 240 may fit, such as a circular opening, a square or rectangular opening (e.g., for a U-shaped quill 220), etc. In this manner, the second portion 344 of the sealing block 304 may surround (e.g., surround) the outer surface of the quill 220.

[0150] In some examples, the wedge 358 can extend axially along the entire length of the seal block 304. For example, the first portion 340 and the second portion 344 of the seal block 304 can include the wedge 358. In some examples, such as Figure 20 As shown in FIG, the axial length of the first portion 340 of the sealing block 304 is equal to the axial length of the groove 336 of the sealing member 302, such that the second end 312 of the sealing member 302 can contact the intermediate surface 360 ​​of the sealing block 304. The intermediate surface 360 ​​can define a transition between the first portion 340 and the second portion 344 of the sealing block 304. In the illustrated example, and in examples where the axial length of the first portion 340 is longer than the axial length of the groove 336 of the sealing member 302, the inner protrusion 330 (and its engagement surface 334) does not extend into the opening 350. In other examples, the axial length of the first portion 340 can be shorter than the axial length of the groove 336, such that the engagement surface 334 of the inner protrusion 330 extends at least partially into the opening 350.

[0151] The second portion 344 of the sealing block 304 may have a cylindrical outer surface. Figure 16 As shown in , the outer diameter of the second portion 344 can be smaller than the inner diameter of the inner wall 256 of the sealing housing 252 to provide a spacing or gap for assembly and / or manufacturing purposes. In other examples, the outer surface of the second portion 344 can contact the inner wall 256 of the sealing housing 252.

[0152] When the seal member 302 and the seal block 304 are coupled together, the wedge 358 contacts the inner surface defining the groove 336. Specifically, the wedge 358 can be configured to hold the inner protrusion 330 in position relative to the seal housing 252 to ensure a seal between the engagement surface 334 of the inner protrusion 330 and the inward-facing surface 244 of the open channel 240. In some examples, the shape of the groove 336 can correspond to the shape of the wedge 358. In other examples, the groove 336 can be tapered or stepped such that the groove 336 is wider at a location closer to the outer surface of the seal member 302 and narrower toward the lower end of the groove 336. In these examples, the wedge 358 can radially extend or expand the narrow portion of the groove 336 against the inward-facing surface 244 of the open channel 240.

[0153] The sealing member 302 and the sealing block 304 can be coupled together, for example, such that the wedge 358 is positioned within the groove 336, the second end 312 of the sealing member 302 contacts the intermediate surface 360, and / or the sealing block 304 contacts the second intermediate surface 338. In some examples, the sealing member 302 and the sealing block 304 can be coupled together after the quill 220 is slidably inserted through the opening 316 of the sealing member 302 and the opening 350 of the sealing block 304. For example, after being coupled to the quill 220, the sealing member 302 and the sealing block 304 can be axially translated until the wedge 356 of the sealing block 304 axially overlaps the inner protrusion 330 of the sealing member 302, the second end 312 of the sealing member 302 contacts the intermediate surface 360, and / or the sealing block 304 contacts the second intermediate surface 338.

[0154] In some cases, the spacing between the sealing block 304 and the quill 220 may be relatively small, such that if the quill 220 is extended through the openings 316, 350 before coupling the sealing member 302 and the sealing block 304, it may be difficult to overlap the wedge 358 on the relatively flexible inner protrusion 330. In some examples, to facilitate easier coupling of the sealing member 302 and the sealing block 304, in some cases, the sealing member 302 and the sealing block 304 may be coupled together before coupling to the open passage 240. For example, after the wedge 358 of the sealing block 304 is axially overlapped with the inner protrusion 330 of the sealing member 302, the quill 220 may be slidably inserted through the opening 316 of the sealing member 302 and the opening 350 of the sealing block 304. When the quill 220 is positioned within the openings 316, 350, the engagement surface 334 of the inner protrusion 330 may contact the inward-facing surface 244.

[0155] As described above, the wedge 358 of the seal block 304 may be similar to the seal housing 252 ( Figure 15) functions to compress a portion of the seal member against the inward-facing surface 244 of the open channel 240. Due to the similar functions of the wedge 258 of the seal housing 252 and the wedge 358 of the seal block 304, in some examples, the seal block 304 may be used in place of the wedge 258. For example, either wedge may be used to compress an engagement surface of the seal member (e.g., engagement surface 134, engagement surface 334, etc.) against the inward-facing surface 244 of the open channel 240. Specifically, while the hemostatic seal 100 is described above with reference to the wedge 258, in some examples, the hemostatic seal 100 may be used with the wedge 358 of the seal block 304. For example, the seal block 304 may be coupled to the second end 124 of the inner seal member 104 such that the wedge 358 is positioned within the groove 136. As another example, the seal member 302 can be positioned within the chamber defined by the upper segment 252a and the lower segment 252b such that the wedge 258 extends within the groove 336. In this example, the seal block 304 can be omitted. In some examples, both the wedge 258 and the wedge 358 can be positioned within the groove (e.g., groove 136, groove 336) of the seal member. For example, the wedge 258 of the seal housing 252 can be positioned axially between the seal member (e.g., the seal member 302, the inner seal member 104) and the wedge 358 of the seal block 304, within the groove of the seal member.

[0156] In some examples, a seal sufficient to provide hemostasis can be created between the engagement surface of the inner protrusion of the seal and the inward-facing surface 244 of the cannula 220 without requiring the positioning of a more rigid component or wedge within the inner protrusion. For example, the chamber of the seal housing 252 can apply a sufficient, constant force to the seal such that the inner protrusion of the seal applies a sufficient sealing force against the inward-facing surface 244 during relative axial movement between the cannula 220 and the seal (e.g., a passive seal).

[0157] Figure 21-22 An example of a passive hemostatic seal 400 that can be positioned within a seal housing 252 is shown. The hemostatic seal 400 includes an outer surface 402 and an inner surface 404 that defines an opening 406. When positioned within the seal housing 252, the outer surface 402 can contact and / or seal against the inner wall 256 of the seal housing. The open channel 240 of the cannula shaft 220 can extend through the opening 406.

[0158] The seal 400 can include an inner protrusion 430 configured to seal against the inward-facing surface 244 of the open channel 240. For example, the inner protrusion 430 can extend radially inward from the outer surface of the seal 400, e.g., in a direction perpendicular to the longitudinal axis of the seal 400 (and perpendicular to the longitudinal axis 225 of the cannula shaft 220). In some examples, as depicted, the inner protrusion 430 extends axially along the entire length of the seal 400, from a first end to a second end of the seal 400. In other examples, the inner protrusion 430 can extend a portion of the entire length of the seal 400. When the hemostasis seal 400 is coupled to the cannula shaft 220, the inner protrusion 430 extends axially along the length of the open channel 240. Specifically, when the cannula shaft 220 is positioned within the opening 406 of the seal 400, the first engagement portion 434 of the inner surface 404 can contact the inward-facing surface 244 of the open channel 240. As shown, engagement surface 434 can generally correspond to and complement the shape of inward-facing surface 244. For example, engagement surface 434 can have an outward-facing surface (e.g., a convex curvature, etc.). In this manner, inner protrusion 430 can extend or protrude into the opening defined by open channel 240, and first engagement surface 434 can seal against inward-facing surface 244. In some cases, inner protrusion 430, or a portion thereof, can comprise a different material (e.g., harder, more rigid, etc.) than the remainder of seal 400.

[0159] The shape of opening 406 can correspond to the cross-sectional shape of open channel 240, being U-shaped, C-shaped, or an incomplete (e.g., partial) ring. For example, inner surface 404 can contact and / or seal against all sides of open channel 240 (e.g., surfaces 244, 246, and edge 248). For example, first engaging portion 434 can seal against inwardly facing surface 244, second engaging portion 410 (e.g., a concave, curved portion, etc.) can seal against outwardly facing surface 246, and third engaging portions 412 disposed on either side of first engaging portion 434 can seal against edge 248.

[0160] When the seal 400 is disposed within the seal housing 252, the inner wall 256, the distal surface 262, and / or the proximal surface 264 can apply a substantially constant force (e.g., rather than a selective compressive locking force applied by the locking knob 254) to the seal 400 to provide a passive hemostatic seal around the open passage 240 of the cannula shaft 220. In this manner, hemostasis can be maintained as the cannula shaft 220 moves relative to the seal 400 and the seal housing 252.

[0161] As described above, the cannula shaft 220 can translate axially relative to other components of the delivery device 200 (e.g., relative to the pusher shaft 212, etc.) during various operations of the delivery device 200. For example, during implantation of a docking device (e.g., docking device 52), a user may need to manipulate the cannula shaft 220 by moving the cannula shaft 220 axially relative to other components of the delivery device 200 multiple times and / or with a high degree of fidelity or control. In some examples, the seals described herein (e.g., seal 100, seal 2400, seal 300, seal 400, etc.) exert a relatively high force on the cannula shaft 220 to create a hemostatic seal around the open channel 240 of the cannula shaft 220. This sealing force can increase the force required to axially move the cannula shaft 220 relative to other components of the delivery device 200.

[0162] In some examples, to reduce the force required to translate the cannula shaft 220 relative to other components of the delivery device 200 while maintaining a hemostatic seal thereabout, a portion of the cannula shaft 220 may include a coating 270 to improve the lubricity of the cannula shaft 220 . Figure 23 and 24 The cannula shaft 220 is shown in greater detail. A lubricious coating 270 can be disposed on the outer surface of the cannula shaft 220 along its length, for example, along a portion of the cannula shaft 220 that extends through the seal (e.g., the open passage 240). Specifically, the coating 270 can be located on the open passage 240 of the cannula shaft 220. In some examples, the coating 270 can extend proximally from a transition between the distal segment 250 of the cannula shaft 220 and the open passage 240 toward the proximal end of the cannula shaft 220.

[0163] In some examples, the coating 270 can extend proximally toward the cannula handle 224, but not completely to the proximal end of the cannula shaft 220. In this way, the location where the cannula handle 224 is coupled to the cannula shaft 220 (e.g., at the proximal end of the cannula shaft 220) does not include the lubricious coating 270 to ensure an adequate connection between the cannula handle 224 and the cannula shaft 220. In some examples, the coating 270 can extend to the proximal end of the cannula shaft 220. In some examples, the coating 270 can also be disposed on a portion of the distal segment 250.

[0164] Coating 270 may be a material that maintains lubricity of cannula shaft 220 during operation of delivery device 200, such that lubricity is maintained over multiple axial movements of cannula shaft 220. In some examples, coating 270 may be a hydrophilic material. In some examples, coating 270 may be a non-stick material. In some examples, coating 270 may be a polytetrafluoroethylene (PTFE) coating or other material that improves lubricity of cannula shaft 220.

[0165] Figure 24 A cross-sectional view of the cannula 220 is shown, taken through the open channel 240. As shown, the coating 270 surrounds or encapsulates the outer surface of the open channel 240, such that the coating 270 is radially outward of the cannula 220. Specifically, the coating 270 is located on the inward-facing surface 244, the outward-facing surface 246, and the edge 248 of the open channel 240. In this manner, the coating 270 defines an outer surface radially outward from the outer surface of the cannula 220. Thus, when a seal (e.g., any of the seals described herein) is coupled to the open channel 240 of the cannula 220, the coating 270 is positioned between the cannula 220 and other components of the delivery device 200 to improve lubricity of the cannula 220. In some examples, the coating 270 can be considered the outer surface of the cannula 220.

[0166] In some examples, the delivery device 200 may include a lubricant to improve the lubricity of the cannula shaft 220. For example, Figure 25 As shown in FIG, the delivery device 200 may include a lubricant chamber 272 positioned adjacent to the hemostatic seal 500, the lubricant chamber containing a supply of lubricant 274. The lubricant 274 may be PTFE grease, silicone oil, or the like. In the illustrated example, the lubricant chamber 272 is positioned within the seal housing 252 and axially between two sealing members of the hemostatic seal 500. One or both of the sealing members of the hemostatic seal 500 may be any of the hemostatic seals described herein (e.g., seal 100, seal 2400, seal 300, seal 400, etc.). As an example, the sealing member of the hemostatic seal 500 positioned distally of the lubricant chamber 272 may be configured as seal 400, and the sealing member of the hemostatic seal 500 positioned proximal to the lubricant chamber 272 may be configured as seal 100. In some examples, the lubricant 274 may be used in addition to or in place of the coating 270.

[0167] The lubricant chamber 272 may be defined by the inner surface of the sealed housing 252. In some examples, such as Figure 25As shown in FIG, lubricant chamber 272 can help maintain the axial position of seal 500 relative to seal housing 252. For example, lubricant chamber 272 can have a diameter that is smaller than the outer diameter of seal 500, so that seal 500 can be positioned against the inner surface of seal housing 252 that defines lubricant chamber 272. In this manner, lubricant chamber 272 can retain a volume of lubricant 274 and can help prevent seal 500 from moving relative to seal housing 252 (e.g., during movement of quill 220). In some examples, seal housing 252 can maintain the position of seal 500 relative to seal housing 252 using other structures (e.g., walls, flanges, lips, etc.) independent of lubricant chamber 272, as described above. In some examples, lubricant chamber 272 can have a diameter that is equal to or greater than the outer diameter of seal 500.

[0168] The open passage 240 of the quill 220 is in fluid communication with the lubricant chamber 272. In this manner, as the quill 220 moves axially relative to the seal housing 252 (and therefore relative to the lubricant chamber 272), the lubricant 274 within the lubricant chamber 272 can coat and improve the lubricity of the open passage 240 of the quill 220. In this manner, the lubricant 274 can be applied to the outer surface of the open passage 240.

[0169] Any of the systems, devices, equipment, etc. herein can be sterilized (e.g., using heat / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure that it is safe for use with patients, and as one of the steps in the method, any of the methods herein may include sterilization of the associated systems, devices, equipment, etc. Examples of heating / heat sterilization include steam sterilization and autoclaving. Examples of radiation used for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. In some examples, the sealing member described herein may be made of silicone, which allows ethylene oxide to diffuse through the material and into the medical device. For example, sterilization using hydrogen peroxide can be accomplished using hydrogen peroxide plasma.

[0170] The therapeutic techniques, methods, procedures, etc. described or suggested herein or in the references incorporated herein can be performed on living animals or on non-living analogs, such as cadavers, cadaver hearts, anthropomorphic phantoms, simulators (e.g., having simulated body parts, tissues, etc.), etc.

[0171] Delivery Technology In order to implant a prosthetic valve into the native aortic valve via a transfemoral delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted into the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and apex of the heart, and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or a right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0172] To implant a prosthetic valve within the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of a delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a puncture created in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0173] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar method can be used to implant the prosthetic valve into the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0174] Another delivery method is a transatrial approach, whereby the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision in the atrial wall (right or left atrium) for access to any native heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, whereby the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision in the right ventricle wall (usually at or near the base of the heart) for implantation into the native tricuspid valve, native pulmonary valve, or pulmonary artery.

[0175] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limiting. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0176] Additional Examples of the Disclosed Technology In view of the above embodiments of the disclosed subject matter, the present application discloses the additional embodiments listed below. It should be noted that one feature of a separate example or more than one feature of an example adopted in combination, and optionally combined with one or more features of one or more other examples, are other examples that also fall within the disclosure of the present application.

[0177] Example 1. A delivery device comprising: a sealing housing; a first shaft extending through the sealing housing and comprising an outward-facing surface and an inward-facing surface, wherein the inward-facing surface defines an open channel; a second shaft comprising a first segment and a second segment, wherein the first segment is disposed within the open channel and wherein the second segment extends out of the open channel and is angled relative to the first segment; and a seal coupled to the first shaft, the seal comprising a first sealing portion and a second sealing portion, wherein the first sealing portion seals a first gap between the sealing housing and the outward-facing surface of the first shaft, wherein the second sealing portion seals a second gap between the sealing housing and the inward-facing surface of the first shaft, wherein the seal maintains a steady state when the first shaft moves relative to the seal.

[0178] Example 2. The delivery device of any example herein, particularly example 1, wherein the seal is compressed against the first shaft when the first shaft moves relative to the seal.

[0179] Example 3. The delivery device of any example herein, particularly example 1 or example 2, wherein the outwardly facing surface of the first shaft is convex, and wherein the inwardly facing surface of the first shaft is concave.

[0180] Example 4. A delivery device according to any example herein, in particular any of Examples 1-3, wherein the second sealing portion comprises an inner protrusion, wherein the inner protrusion comprises a groove and an engagement surface, wherein the engagement surface of the inner protrusion contacts the inward-facing surface of the first shaft.

[0181] Example 5. A delivery device according to any example herein, particularly Example 4, wherein a portion of the seal housing extends radially into the groove, wherein the portion of the seal housing is configured to compress the engagement surface against the inwardly facing surface of the first shaft.

[0182] Example 6. The delivery device according to any example herein, particularly example 4 or example 5, further comprising a sealing block coupled to the seal, wherein the sealing block comprises a wedge, and wherein the wedge is positioned within the groove.

[0183] Example 7. The delivery device of any example herein, particularly Example 6, wherein the seal has a durometer hardness lower than a durometer hardness of the sealing block.

[0184] Example 8. The delivery device according to any example herein, in particular any of Examples 1-7, further comprising a locking mechanism operatively coupled to the first shaft to prevent movement of the first shaft relative to the seal, wherein the seal maintains a steady state independent of the locking mechanism.

[0185] Example 9. A delivery device comprising: a sealing housing; a first shaft extending through the sealing housing and comprising an outward-facing surface and an inward-facing surface, wherein the inward-facing surface defines an open channel; a second shaft comprising a first segment and a second segment, wherein the first segment is disposed within the open channel and wherein the second segment extends out of the open channel and is angled relative to the first segment; and a sealing assembly coupled to the first shaft, the seal comprising a first sealing member and a second sealing member, wherein the first sealing member seals a first gap between the sealing housing and the outward-facing surface of the first shaft, wherein the second sealing member seals a second gap between the sealing housing and the inward-facing surface of the first shaft, wherein the seal maintains a steady state as the first shaft moves relative to the seal.

[0186] Example 10. The delivery device of any example herein, particularly Example 9, wherein the seal housing compresses the seal assembly against the first shaft when the first shaft moves relative to the seal.

[0187] Example 11. The delivery device according to any example herein, particularly example 9 or example 10, wherein the cross-section of the first shaft is partially annular.

[0188] Example 12. The delivery device according to any example herein, in particular any of Examples 9-11, wherein the outwardly facing surface of the first shaft is convex, and wherein the inwardly facing surface of the first shaft is concave.

[0189] Example 13. The delivery device of any example herein, particularly any of Examples 9-12, wherein the second sealing member comprises an inner protrusion having an engagement surface, wherein the engagement surface contacts the inwardly facing surface of the first shaft.

[0190] Example 14. A delivery device according to any example herein, particularly Example 13, wherein the second sealing member includes an opening extending axially from the first end of the second sealing member to the second end of the second sealing member, wherein the first shaft extends through the opening of the second sealing member.

[0191] Example 15. The delivery device of any example herein, particularly Example 14, wherein the inner protrusion extends radially inwardly into the opening, and wherein the inner protrusion is disposed at the second end of the second sealing member.

[0192] Example 16. The delivery device of any example herein, particularly Example 15, wherein the second sealing member comprises an intermediate surface disposed axially between the first end and the second end, wherein the axial end of the inner protrusion defines the intermediate surface.

[0193] Example 17. The delivery device of any example herein, particularly Example 16, wherein the second sealing member comprises a groove extending axially along the length of the inner protrusion.

[0194] Example 18. A delivery device according to any example herein, particularly Example 17, wherein the groove is an axial through groove extending through the entire length of the inner protrusion, such that a first end of the groove is defined by the intermediate surface and a second end of the groove is defined by the second end of the second sealing member.

[0195] Example 19. The delivery device of any example herein, particularly example 17, wherein the axial length of the slot is less than the entire length of the inner protrusion.

[0196] Example 20. The delivery device of any example herein, particularly any of Examples 17-19, wherein the sealed housing includes an inner wall defining a chamber, wherein the sealing assembly is positioned within the chamber, and wherein the sealing assembly contacts the inner wall.

[0197] Example 21. A delivery device according to any example herein, particularly Example 20, wherein the inner wall includes a wedge, wherein the wedge protrudes radially inward into the groove, and wherein the wedge of the sealing housing is configured to compress the engagement surface against the inward-facing surface of the first shaft.

[0198] Example 22. The delivery device according to any example herein, particularly any of Examples 17-21, further comprising a sealing block coupled to the sealing assembly, wherein the sealing block comprises a wedge, and wherein the wedge of the sealing block is positioned within the groove.

[0199] Example 23. The delivery device of any example herein, particularly Example 22, wherein the seal assembly has a lower durometer hardness than the seal block.

[0200] Example 24. The delivery device of any example herein, particularly any of examples 9-23, wherein the first sealing member and the second sealing member partially overlap in the axial direction.

[0201] Example 25. The delivery device of any example herein, particularly any of Examples 9-23, wherein the first sealing member comprises an inner surface defining an opening, wherein the first shaft extends through the opening of the first sealing member.

[0202] Example 26. The delivery device of any example herein, in particular example 25, wherein the opening of the first sealing member is D-shaped.

[0203] Example 27. The delivery device of any example herein, particularly example 25 or example 26, wherein the inner surface of the first sealing member comprises a step.

[0204] Example 28. The delivery device of any example herein, in particular example 27, wherein one end of the second sealing member contacts the step.

[0205] Example 29. The delivery device according to any example herein, in particular any of Examples 9-28, further comprising a handle, wherein the handle comprises a straight segment and a branch segment angled relative to the straight segment, wherein the first axis extends through the straight segment, and wherein the second axis is at least partially disposed within the branch segment.

[0206] Example 30. The delivery device of any example herein, particularly Example 29, wherein the seal housing is coupled to the straight segment.

[0207] Example 31. The delivery device according to any example herein, in particular any of Examples 9-29, further comprising a locking mechanism operatively coupled to the first shaft to prevent movement of the first shaft relative to the seal, wherein the seal maintains a steady state independent of the locking mechanism.

[0208] Example 32. A delivery device comprising: a sealing housing; a shaft extending through the sealing housing, wherein the shaft includes an outer surface, wherein the outer surface includes an inward-facing portion and an outward-facing portion; and a sealing member disposed within the sealing housing, wherein the sealing member includes an inner surface defining an opening, wherein the shaft extends through the opening of the sealing member, wherein the sealing member includes an inner protrusion having an engagement surface, wherein the engagement surface seals against the inward-facing portion of the outer surface of the shaft, wherein the sealing member provides hemostasis when the shaft moves relative to the sealing member.

[0209] Example 33. The delivery device according to any example herein, in particular Example 32, further comprising an external sealing member coupled to the sealing member, wherein the external sealing member comprises an inner surface defining an opening, wherein the shaft extends through the opening of the external sealing member, and wherein the inner surface seals against the outward-facing portion of the outer surface of the shaft.

[0210] Example 34. The delivery device of any example herein, in particular example 33, wherein the opening of the outer sealing member is D-shaped.

[0211] Example 35. The delivery device of any example herein, in particular any of Examples 32-34, wherein the inner protrusion comprises a slot extending in an axial direction along the length of the inner protrusion.

[0212] Example 36. The delivery device of any example herein, particularly Example 35, wherein the length is less than the entire length of the inner protrusion.

[0213] Example 37. The delivery device of any example herein, in particular example 35, wherein the slot extends the entire length of the inner protrusion.

[0214] Example 38. The delivery device according to any example herein, in particular any of Examples 35-37, further comprising a sealing block coupled to the sealing member, wherein the sealing block comprises a wedge, wherein the wedge is positioned within the groove.

[0215] Example 39. The delivery device of any example herein, particularly Example 38, wherein the sealing block has a higher durometer hardness than the sealing member.

[0216] Example 40. The delivery device of any example herein, particularly example 38 or example 39, wherein the engagement surface is positioned radially between the inwardly facing portion of the shaft and the wedge.

[0217] Example 41. A sealing assembly for a delivery device, the sealing assembly comprising: a first sealing member, the first sealing member defining a first opening extending through the first sealing member in an axial direction, wherein the first opening includes an inward-facing surface, the inward-facing surface being configured to seal against an outward-facing surface of a shaft; and a second sealing member connected to the first sealing member, the second sealing member defining a second opening extending through the second sealing member in the axial direction, wherein the second sealing member includes an inner protrusion extending in a radial direction into the second opening, wherein the inner protrusion includes an outward-facing engagement surface, wherein the engagement surface is configured to seal against the inward-facing surface of the shaft.

[0218] Example 42. A sealing assembly according to any example herein, in particular Example 41, wherein the second sealing member has a first end, a second end, and an intermediate surface axially disposed between the first end and the second end, and wherein the inner protrusion is disposed at the second end of the second sealing member and defines the intermediate surface.

[0219] Example 43. The seal assembly of any example herein, particularly Example 42, wherein the inner protrusion includes a groove extending along an axial length of the inner protrusion, wherein the groove opens in a radial direction through an outer surface of the second seal member.

[0220] Example 44. The seal assembly of any example herein, particularly Example 43, wherein the groove defines a third opening extending through the second seal member in the axial direction.

[0221] Example 45. The seal assembly of any example herein, particularly any of Examples 41-44, wherein the second seal member includes an axial extension at the first end of the second seal member, the axial extension being disposed around an outer surface of the first seal member.

[0222] Example 46. The seal assembly of any example herein, particularly Example 45, wherein the outer surface of the first seal member includes a step.

[0223] Example 47. The seal assembly of any example herein, particularly Example 46, wherein the axial extension contacts the step when the first and second seal members are coupled together.

[0224] Example 48. The seal assembly of any example herein, particularly any of Examples 40-47, wherein the first opening is D-shaped.

[0225] Example 49. The seal assembly of any example herein, particularly any of Examples 40-48, wherein the second opening is partially annular.

[0226] Example 50. A seal for a delivery device, the seal comprising: a body having a first sealing portion and a second sealing portion, the first sealing portion being axially spaced apart from the second sealing portion, wherein the first sealing portion includes an opening having an inwardly facing surface, and wherein the second sealing portion includes an inner protrusion having an outwardly facing surface.

[0227] Example 51. A seal according to any example herein, in particular example 50, wherein the opening is D-shaped.

[0228] Example 52. A seal according to any example herein, particularly examples 50 or 51, wherein the inner protrusion comprises a groove extending along an axial length of the inner protrusion, wherein the groove opens in a radial direction through an outer surface of the seal.

[0229] Example 53. The seal of any example herein, in particular example 52, wherein the groove is open in an axial direction through an end of the seal.

[0230] Example 54. The delivery device of any example herein, particularly any one of Examples 1-40, wherein the delivery device is sterilized.

[0231] Example 55. A delivery device comprising: a cannula comprising a first segment and a second segment, wherein the second segment comprises an inwardly facing outer surface and an outwardly facing outer surface, wherein the second segment comprises a lubricious coating; and a seal coupled to the second segment of the cannula.

[0232] Example 56. The delivery device of any example herein, particularly Example 55, wherein the first segment has an annular cross-section, and wherein the second segment has a partially annular cross-section.

[0233] Example 57. The delivery device of any example herein, in particular example 55 or example 56, wherein the inwardly facing outer surface is concave and the outwardly facing outer surface is convex.

[0234] Example 58. The delivery device of any example herein, particularly any of Examples 55-57, wherein the lubricious coating comprises a PTFE coating.

[0235] Example 59. The delivery device of any example herein, particularly any of Examples 55-58, wherein the cannula shaft is axially movable relative to the seal.

[0236] Example 60. The delivery device of any example herein, particularly any of Examples 55-59, further comprising a seal housing, wherein the cannula shaft extends through the seal housing, and wherein the seal is disposed within the seal housing.

[0237] Example 61. A delivery device according to any example herein, particularly Example 60, wherein the seal comprises a first sealing portion and a second sealing portion, wherein the first sealing portion seals a first gap between the seal housing and the outward-facing outer surface of the cannula shaft, wherein the second sealing portion seals a second gap between the seal housing and the inward-facing outer surface of the cannula shaft, and wherein the seal maintains a steady state when the cannula shaft moves relative to the seal.

[0238] Example 62. A delivery device according to any example herein, particularly Example 60, wherein the seal comprises an inner surface defining an opening, wherein the cannula shaft extends through the opening of the seal, wherein the seal comprises an inner protrusion having an engagement surface, wherein the engagement surface seals against the inwardly facing outer surface of the cannula shaft, and wherein the seal provides hemostasis when the cannula shaft moves relative to the seal.

[0239] Example 63. A delivery device according to any example herein, particularly Example 60, wherein the seal comprises a first sealing member and a second sealing member, wherein the first sealing member seals a first gap between the seal housing and the outward-facing outer surface of the cannula shaft, wherein the second sealing member seals a second gap between the seal housing and the inward-facing outer surface of the cannula shaft, and wherein the seal maintains a steady state when the cannula shaft moves relative to the seal.

[0240] Example 64. The delivery device according to any example herein, in particular any of Examples 55-63, further comprising a second shaft that is axially movable relative to the cannula shaft and extends through the first segment of the cannula shaft, wherein a portion of the second shaft is angled relative to the cannula shaft.

[0241] Example 65. A delivery device comprising: a sealed housing defining a lubricant chamber containing a lubricant; a seal disposed within the sealed housing; and a cannula extending through the sealed housing, the cannula including a first segment and a second segment, wherein the second segment extends through the lubricant chamber and the seal, wherein the second segment includes an inwardly facing outer surface and an outwardly facing outer surface.

[0242] Example 66. The delivery device of any example herein, particularly Example 65, wherein the first segment has an annular cross-section, and wherein the second segment has a partially annular cross-section.

[0243] Example 67. A delivery device according to any example herein, in particular example 65 or example 66, wherein the inwardly facing outer surface is concave and the outwardly facing outer surface is convex.

[0244] Example 68. The delivery device of any example herein, particularly any of Examples 65-67, wherein the lubricant comprises PTFE grease or silicone oil.

[0245] Example 69. The delivery device of any example herein, particularly any of Examples 65-68, wherein the cannula shaft is axially movable relative to the seal.

[0246] Example 70. A delivery device according to any example herein, particularly any of Examples 65-69, wherein the seal comprises a first sealing member positioned distal to the lubricant chamber, and wherein the seal comprises a second sealing member positioned proximal to the lubricant chamber.

[0247] Example 71. A delivery device according to any example herein, particularly any of Examples 65-70, wherein the seal comprises a first sealing portion and a second sealing portion, wherein the first sealing portion seals a first gap between the seal housing and the outward-facing outer surface of the cannula shaft, wherein the second sealing portion seals a second gap between the seal housing and the inward-facing outer surface of the cannula shaft, and wherein the seal maintains a steady state when the cannula shaft moves relative to the seal.

[0248] Example 72. A delivery device according to any example herein, particularly any of Examples 65-70, wherein the seal comprises an inner surface defining an opening, wherein the cannula shaft extends through the opening of the seal, wherein the seal comprises an inner protrusion having an engagement surface, wherein the engagement surface seals against the inwardly facing outer surface of the cannula shaft, and wherein the seal provides hemostasis when the cannula shaft moves relative to the seal.

[0249] Example 73. A delivery device according to any example herein, particularly Example 70, wherein the first sealing member seals a first gap between the sealing housing and the outward-facing outer surface of the cannula shaft, wherein the second sealing member seals a second gap between the sealing housing and the inward-facing outer surface of the cannula shaft, and wherein the seal maintains a steady state when the cannula shaft moves relative to the seal.

[0250] Example 74. The delivery device according to any example herein, in particular any of Examples 65-73, further comprising a second shaft that is axially movable relative to the cannula shaft and extends through the first segment of the cannula shaft, wherein a portion of the second shaft is angled relative to the cannula shaft.

[0251] Example 75. The delivery device of any example herein, particularly any of Examples 55-74, wherein the delivery device is sterilized.

[0252] Unless otherwise stated, features described herein with respect to any example can be combined with other features described in any one or more of the other examples. For example, any one or more features of one axis can be combined with any one or more features of another axis. As another example, any one or more features of one delivery device can be combined with any one or more features of another delivery device.

[0253] In view of the many possible ways in which the principles of the present disclosure can be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure, nor should they be taken as limiting the claims. Instead, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A delivery device comprising: Sealed housing; a first shaft extending through the sealed housing and including an outwardly facing surface and an inwardly facing surface, wherein the inwardly facing surface defines an open passage; a second shaft comprising a first segment and a second segment, wherein the first segment is disposed within the open channel, and wherein the second segment extends out of the open channel and is angled relative to the first segment; as well as a seal coupled to the first shaft, the seal comprising a first seal portion and a second seal portion, wherein the first seal portion seals a first gap between the seal housing and the outward-facing surface of the first shaft, wherein the second seal portion seals a second gap between the seal housing and the inward-facing surface of the first shaft, wherein the seal maintains a steady state when the first shaft moves relative to the seal. 2 . The delivery device of claim 1 , wherein the seal compresses against the first shaft when the first shaft moves relative to the seal.

3. The delivery device of claim 1 or claim 2, wherein the outwardly facing surface of the first shaft is convex, and wherein the inwardly facing surface of the first shaft is concave.

4. The delivery device of any one of claims 1 to 3, wherein the second sealing portion comprises an inner protrusion, wherein the inner protrusion includes a groove and an engagement surface, wherein the engagement surface of the inner protrusion contacts the inwardly facing surface of the first shaft.

5. The delivery device of claim 4, wherein a portion of the seal housing extends radially into the groove, wherein the portion of the seal housing is configured to compress the engagement surface against the inwardly facing surface of the first shaft.

6. The delivery device of claim 4 or claim 5, further comprising a sealing block coupled to the seal, wherein the sealing block includes a wedge, and wherein the wedge is positioned within the groove.

7. The delivery device of claim 6, wherein the seal has a lower durometer hardness than the seal block.

8. The delivery device of any one of claims 1 to 7, further comprising a locking mechanism operatively coupled to the first shaft to prevent movement of the first shaft relative to the seal, wherein the seal maintains a steady state independent of the locking mechanism.

9. A delivery device comprising: Sealed housing; a shaft extending through the sealed housing, wherein the shaft includes an outer surface, wherein the outer surface includes an inwardly facing portion and an outwardly facing portion; as well as a sealing member disposed within the seal housing, wherein the sealing member includes an inner surface defining an opening, wherein the shaft extends through the opening of the sealing member, wherein the sealing member includes an inner protrusion having an engagement surface, wherein the engagement surface seals against the inwardly facing portion of the outer surface of the shaft, wherein the sealing member provides hemostasis when the shaft moves relative to the sealing member.

10. The delivery device of claim 9, further comprising an outer sealing member coupled to the sealing member, wherein the outer sealing member comprises an inner surface defining an opening, wherein the shaft extends through the opening of the outer sealing member, wherein the inner surface seals against the outwardly facing portion of the outer surface of the shaft.

11. The delivery device of claim 10, wherein the opening of the outer sealing member is D-shaped.

12. The delivery device of any one of claims 9 to 11, wherein the inner protrusion comprises a slot extending in an axial direction along the length of the inner protrusion.

13. The delivery device of claim 12, wherein the length is less than the entire length of the inner protrusion.

14. The delivery device of claim 12, wherein the slot extends the entire length of the inner protrusion.

15. The delivery device of any one of claims 12 to 14, further comprising a sealing block coupled to the sealing member, wherein the sealing block includes a wedge, wherein the wedge is positioned within the groove.

16. The delivery device of claim 15, wherein the sealing block has a higher durometer hardness than the sealing member.

17. The delivery device of claim 15 or claim 16, wherein the engagement surface is located radially between the inwardly facing portion of the shaft and the wedge.

18. A sealing assembly for a delivery device, the sealing assembly comprising: a first sealing member defining a first opening extending therethrough in an axial direction, wherein the first opening includes an inwardly facing surface configured to seal against an outwardly facing surface of a shaft; as well as a second sealing member coupled to the first sealing member, the second sealing member defining a second opening extending through the second sealing member in the axial direction, wherein the second sealing member includes an inner protrusion extending into the second opening in a radial direction, wherein the inner protrusion includes an outwardly facing engagement surface, wherein the engagement surface is configured to seal against an inwardly facing surface of the shaft.

19. The seal assembly of claim 18, wherein the second seal member has a first end, a second end, and an intermediate surface disposed axially between the first and second ends, and wherein the inner protrusion is disposed at the second end of the second seal member and defines the intermediate surface.

20. A seal for a delivery device, the seal comprising: A body having a first sealing portion and a second sealing portion, the first sealing portion being axially spaced from the second sealing portion, wherein the first sealing portion includes an opening having an inwardly facing surface, and wherein the second sealing portion includes an inner protrusion having an outwardly facing surface.

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