Delivery device seal

Abstract

Disclosed are devices and methods for sealing. By way of example, a delivery apparatus includes a sleeve shaft having a first segment and a second segment, the second segment having an inwardly facing outer surface and an outwardly facing outer surface, the second segment including a lubricious coating and a seal coupled to the second segment of the sleeve shaft.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 582,373, filed September 13, 2023, and U.S. Provisional Patent Application No. 63 / 482,210, filed January 30, 2023, which are incorporated by reference herein in their entireties.

[0002] SUMMARY The present disclosure relates to seals for delivery apparatus for prosthetic medical devices. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to serious cardiac dysfunction and ultimately require repair of the native valve or replacement of the native valve with a prosthetic valve. There are several known repair devices (e.g., stents) and prosthetic valves, as well as several known methods for implanting these devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations within the body that are not easily accessible by surgery or where non-surgical access is desirable. 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 vasculature (e.g., through the femoral artery or femoral vein) until the prosthetic valve reaches the implantation site within the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon to which the prosthetic valve is attached, by activating a mechanical actuator that applies an expansive force to the prosthetic valve, or by deploying the prosthetic valve from a sheath in the delivery device and allowing the prosthetic valve to self-expand to its functional size.

[0004] In some cases, the docking device may be initially implanted within the native valve and configured to receive the prosthetic valve and secure (e.g., anchor) the prosthetic valve in a desired position within the native valve. For example, the docking device may form a more circular and / or stable fixation site at the annulus of the native valve where the prosthetic valve can be expanded and implanted. A transcatheter delivery device may be used to deliver the docking device to the implantation site. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. 2020 / 247907 [Patent Document 2] International Application No. PCT / US2021 / 056150 [Patent Document 3] International Application No. PCT / US2020 / 036577 [Patent Document 4] US Patent Application Publication No. 2018 / 0318079 [Patent Document 5] US Patent Application Publication No. 2018 / 0263764 Summary of the Invention

[0006] Described herein are prosthetic heart valves, docking devices, delivery apparatus, and methods for implanting the prosthetic heart valves. The disclosed prosthetic heart valves, docking devices, delivery apparatus, and methods can provide a passive hemostatic seal around, for example, a shaft having an open channel, so that the open channel is sealed independently of the shaft's locking mechanism. Thus, the devices and methods disclosed herein can overcome, among other things, one or more of the deficiencies of typical prosthetic heart valves, docking devices, and related delivery apparatus.

[0007] The delivery device may include a handle and one or more shafts coupled to the handle.

[0008] In some examples, the delivery device can include a handle, a shaft coupled to the handle, and a passive seal coupled to the shaft, the seal providing constancy as the shaft moves relative to the seal.

[0009] In some examples, the delivery device can include a seal housing; a first shaft extending through the seal housing and including an outward-facing surface and an inward-facing surface, the inward-facing surface defining an open channel; a second shaft including a first segment and a second segment, the first segment disposed within the open channel and the second segment extending from the open channel and angled relative to the first segment; and a seal coupled to the first shaft, the seal including a first sealing portion and a second sealing portion, the first sealing portion sealing a first gap between the seal housing and the outward-facing surface of the first shaft and the second sealing portion sealing a second gap between the seal housing and the inward-facing surface of the first shaft, the seal providing constancy when the first shaft moves relative to the seal.

[0010] In some examples, a delivery device can include a seal housing; a first shaft extending through the seal housing and having an outward-facing surface and an inward-facing surface, the inward-facing surface defining an open channel; a second shaft having a first segment and a second segment, the first segment disposed within the open channel and the second segment extending from the open channel and angled relative to the first segment; and a seal assembly coupled to the first shaft, the seal including a first sealing member and a second sealing member, the first sealing member sealing a first gap between the seal housing and the outward-facing surface of the first shaft and the second sealing member sealing a second gap between the seal housing and the inward-facing surface of the first shaft, the seal providing constancy when the first shaft moves relative to the seal.

[0011] In some examples, the delivery device can include a seal housing, a shaft extending through the seal housing, the shaft having an outer surface, the outer surface having an inwardly facing portion and an outwardly facing portion, and a sealing member disposed within the seal housing, the sealing member having an inner surface defining an opening, the shaft extending through the opening of the sealing member, the sealing member including an inner protrusion having an engagement surface that seals against the inwardly facing portion of the outer surface of the shaft, the sealing member providing hemostasis when the shaft is moved relative to the sealing member.

[0012] In some examples, the delivery device can include a sleeve shaft comprising a first segment and a second segment, the second segment comprising an inwardly facing outer surface and an outwardly facing outer surface, the second segment comprising a lubricious coating and a seal coupled to the second segment of the sleeve shaft.

[0013] In some examples, the delivery device can include a seal housing defining a lubricant chamber containing a lubricant, a seal disposed within the seal housing, and a sleeve shaft extending through the seal housing, the sleeve shaft including a first segment and a second segment, the second segment extending through the lubricant chamber and the seal, the second segment including an inwardly facing outer surface and an outwardly facing outer surface.

[0014] A seal assembly for a delivery device can include a plurality of sealing members coupled together to form a seal therebetween, each sealing member defining an axially extending opening.

[0015] In some examples, a seal assembly for a delivery device can include a first sealing member, the first sealing member defining a first opening extending axially therethrough, the first opening including an inward-facing surface 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 axially therethrough, the second sealing member including an inner protrusion extending radially into the second opening, the inner protrusion including an outward-facing engagement surface configured to seal against the inward-facing surface of the shaft.

[0016] A seal for a delivery device can include a body defining an opening for a shaft, the body including an inwardly facing surface and an outwardly facing surface configured to seal against the shaft.

[0017] In some examples, a seal for a delivery device can include a body having a first sealing portion and a second sealing portion, the first sealing portion being axially spaced from the second sealing portion, the first sealing portion including an opening having an inwardly facing surface, and the second sealing portion including an inner protrusion having an outwardly facing surface.

[0018] The various innovations in this disclosure can be used in combination or separately. This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. These and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, the claims, and the accompanying drawings. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 schematically illustrates steps in an exemplary mitral valve replacement procedure in which a guide catheter and guidewire are inserted into a patient's blood vessels and navigated through the blood vessels into the patient's heart toward the heart's native mitral valve. [Figure 2A] FIG. 2A schematically illustrates another stage in an exemplary mitral valve replacement procedure 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. [Figure 2B] FIG. 2B schematically illustrates another stage in an exemplary mitral valve replacement procedure in which the docking device of FIG. 2A has been fully implanted at the patient's native mitral valve and the docking device delivery apparatus has been removed from the patient. [Figure 3A] FIG. 3A schematically illustrates another stage in an exemplary mitral valve replacement procedure, in which a prosthetic heart valve delivery device extending through a guide catheter implants a prosthetic heart valve within an implanted docking device at the native mitral valve. [Figure 3B] FIG. 3B schematically illustrates another stage in an exemplary mitral valve replacement procedure, in which the prosthetic heart valve has been fully implanted within the docking device at the native mitral valve and the prosthetic heart valve delivery apparatus has been removed from the patient. [Figure 4] FIG. 4 illustrates schematically another stage in an exemplary mitral valve replacement procedure, where the guide catheter and guidewire have been removed from the patient. [Figure 5] FIG. 5 is a side view of a docking device according to an example. [Figure 6A] FIG. 6A is a side view of a delivery apparatus for a docking device, according to an example. [Figure 6B] FIG. 6B illustrates a portion of the delivery device of FIG. 6A. [Figure 7] FIG. 7 illustrates a portion of the shaft assembly of the delivery device of FIG. 6A. [Figure 8]FIG. 8 is a perspective view of an active hemostatic seal configured to seal around a sleeve shaft of a delivery apparatus for a docking device. [Figure 9] 9 is a perspective view of the active hemostatic seal of FIG. 8 positioned within a seal housing around a sleeve shaft. [Figure 10] FIG. 10 is a cross-sectional side view of a passive hemostatic seal assembly positioned within a seal housing, according to one example. [Figure 11] FIG. 11 is a perspective view of the seal assembly of FIG. [Figure 12A] 12A is an additional view of the sealing member of the seal assembly of FIG. 10. [Figure 12B] 12B is an additional view of the sealing member of the seal assembly of FIG. [Figure 13A] 13A is an additional view of the sealing member of the seal assembly of FIG. 10. [Figure 13B] 13B is an additional view of the sealing member of the seal assembly of FIG. [Figure 14] 14 is a perspective view of the seal assembly of FIG. 10 coupled to a sleeve shaft. [Figure 15] 15 is a perspective view of one segment of the seal housing of FIG. 10. FIG. [Figure 16] FIG. 16 is a cross-sectional side view of a passive hemostatic seal positioned within a seal housing, according to one embodiment. [Figure 17] FIG. 17 is a perspective view of the seal of FIG. 16 with the seal housing cap removed for illustrative purposes. [Figure 18A] 18A is an additional view of the sealing member of the seal of FIG. 16. FIG. [Figure 18B] 18B is an additional view of the sealing member of the seal of FIG. [Figure 18C] 18C is an additional view of the sealing member of the seal of FIG. [Figure 18D] FIG. 18D is an additional view of the sealing member of the seal of FIG. [Figure 19] FIG. 19 is a perspective view of the seal of FIG. 16 coupled to a sleeve shaft. [Figure 20] 20 is a cross-sectional perspective view of the seal of FIG. 16 coupled to a sleeve shaft. [Figure 21] FIG. 21 is a perspective view of a passive hemostatic seal, according to one example. [Figure 22] FIG. 22 is an end view of the seal of FIG. [Figure 23] FIG. 23 is a side view of a proximal portion of a sleeve shaft, according to an example. [Figure 24] FIG. 24 is a cross-sectional view of the sleeve shaft taken along section 24-24 of FIG. [Figure 25] FIG. 25 is a cross-sectional side view of a passive hemostatic seal assembly and lubricant chamber positioned within a seal housing, according to one example. DETAILED DESCRIPTION OF THE INVENTION

[0020] Basic premise

[0021] For purposes of description, certain aspects, advantages, and novel configurations of examples of the present disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the present disclosure covers all novel and non-obvious features and aspects of the various disclosed examples, alone, in various combinations with each other, and in various subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed examples require that any one or more particular advantages be present or problems be solved.

[0022] Although some operations in the disclosed examples are described in a particular sequential order for convenience of presentation, it should be understood that this description style encompasses reordering unless a particular order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be reordered or performed simultaneously. Also, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in combination with other methods. Also, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are readily discernible by those skilled in the art.

[0023] As used in this application and in 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." Furthermore, the term "coupled" generally means to physically, mechanically, chemically, magnetically, and / or electrically join or link, and does not exclude the existence of intervening elements between coupled or associated items, unless specific language to the contrary exists.

[0024] As used herein, the term "proximal" refers to a position, orientation, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, orientation, or portion of a device that is away 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 a 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," unless expressly defined otherwise, refer to axes extending in the proximal and distal directions.

[0025] As used herein, "eg" means "for example" and "ie" means "that is."

[0026] Introduction to the Disclosed Technology

[0027] Described herein are examples of steerable delivery apparatuses (sometimes referred to as steerable catheters) that can be used to navigate a subject's vasculature to deliver implantable medical devices (e.g., prosthetic heart valves, docking devices), tools, medications, or other therapies to locations within a subject's body. Examples of procedures for which steerable catheters are useful include neurological, urological, reproductive, fertility (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvascular, transrectal, and procedures involving access to any body canal or cavity. Specific examples include placing implants, including stents, grafts, embolic coils, etc.; positioning imaging devices and / or components thereof, including ultrasound transducers; and positioning energy sources, such as for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, etc.

[0028] In this regard, the present specification describes various systems, devices, methods, etc. that can, in some instances, create a passive seal relative to the shaft of a delivery device such that the shaft is sealed (e.g., a constant seal) as it translates relative to other components of the delivery device.

[0029] Examples of the disclosed technology

[0030] 1-4 illustrate an example of a transcatheter heart valve replacement procedure (e.g., mitral valve replacement) utilizing a docking device 52 and a prosthetic heart valve 62, according to one embodiment. During the procedure, a user first uses a guide catheter 30 to create a pathway to a patient's native heart valve (FIG. 1). The user then uses a docking device delivery apparatus 50 to deliver and implant a docking device 52 to the patient's native heart valve (FIG. 2A), and then removes the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 (FIG. 2B). The user then uses a prosthetic valve delivery apparatus 60 to implant a prosthetic heart valve 62 within the implanted docking device 52 (FIG. 3A). The user then removes the prosthetic valve delivery apparatus 60 from the patient 10 (FIG. 3B), and then removes the guide catheter 30 (FIG. 4).

[0031] 1 illustrates a stage in a mitral valve replacement procedure, according to one embodiment, in which a guide catheter 30 and a guidewire 40 are inserted into a blood vessel 12 of a patient 10 and navigated 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 be navigated through and along the implantation site (the native mitral valve 16 or the native mitral valve annulus). As shown, the heart 14 is depicted schematically. For example, the anterior leaflet and chordae tendineae of the native mitral valve 16 are omitted for illustrative purposes, such that only a portion of the posterior leaflet of the native mitral valve 16 is shown.

[0032] Initially, a user may first make an incision in a patient's body to access blood vessel 12. For example, in the example shown in Figure 1, a user may make an incision in the patient's groin to access the femoral vein. Thus, in such an example, blood vessel 12 may be the femoral vein.

[0033] After forming the incision in the blood vessel 12, a user may insert a guide catheter 30, a guidewire 40, and / or additional devices (such as an introducer device or a transseptal puncture device) through the incision and into the blood vessel 12. The guide catheter 30 (which may also be referred to as an "introducer device," "introducer," or "guide sheath") is configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., a docking device delivery apparatus 50 and a prosthetic valve delivery apparatus 60) into and through the blood vessel 12 and may extend through the blood vessel 12 into the heart 14, but may stop short of 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 may extend through the blood vessel 12 into the heart 14, while the handle 32 remains outside the body of the patient 10 and may be manipulated by a user to operate the shaft 34 ( FIG. 1 ).

[0034] 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, an additional catheter, or the like) and associated devices (e.g., a docking device, a prosthetic heart valve, or the like) to an implantation site within the heart 14, and thus may extend entirely through the blood vessels 12 into the left atrium 18 of the heart 14 and, in some embodiments, through the native mitral valve 16 into the left ventricle of the heart 14 (FIG. 1).

[0035] In some instances, a transseptal puncture device or transseptal puncture catheter may be used to initially access the left atrium 18 before inserting the guidewire 40 and guide catheter 30. For example, after making an incision in the blood vessel 12, a user may insert a transseptal puncture device into the blood vessel 12 through the incision. The user may 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 may 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 may 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. After the guidewire 40 is positioned within the left atrium 18 and / or left ventricle 26, the transseptal puncture device may be removed from the patient 10. The user may then insert guide catheter 30 into blood vessel 12 and advance it over guidewire 40 into left atrium 18 (FIG. 1).

[0036] In some instances, an introducer device can be inserted through the lumen of the guide catheter 30 before inserting the guide catheter 30 into the blood vessel 12. In some instances, the introducer device can include a tapered end protruding from the distal tip of the guide catheter 30, the tapered end being configured to guide the guide catheter 30 over the guidewire 40 into the left atrium 18. Additionally, in some instances, the introducer device can include a proximal end portion protruding from 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 from within 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 a position to receive an implant delivery apparatus and help guide it into the left atrium 18, as described further below.

[0037] FIG. 2A shows another stage in an exemplary mitral valve replacement procedure in which a docking device 52 is implanted into the native mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery device 50 (which may also be referred to as an "implant catheter" and / or a "docking device delivery device").

[0038] Generally, docking device delivery apparatus 50 includes a delivery shaft 54, a handle 56, and a pusher assembly 58. Delivery shaft 54 ​​is configured to be advanced by a user through the patient's vasculature (blood vessel 12) to an implantation site (e.g., native mitral valve 16) and can be configured to retain docking device 52 within a distal end portion 53 of delivery shaft 54. In some embodiments, distal end portion 53 of delivery shaft 54 ​​retains docking device 52 therein in a straight delivery configuration.

[0039] 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 for advancing the delivery shaft 54 ​​through the patient's vasculature (e.g., blood vessel 12).

[0040] In some embodiments, the handle 56 can include one or more articulation members 57 (or rotatable knobs) configured to assist in steering the delivery shaft 54 ​​through the blood vessel 12. For example, the one or more articulation members 57 can include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to bend, curve, twist, rotate, and / or otherwise articulate the distal end portion 53 of the delivery shaft 54 ​​to assist in steering the delivery shaft 54 ​​through the blood vessel 12 and within the heart 14.

[0041] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at the implantation site (e.g., the native mitral valve 16). For example, the pusher assembly 58 is 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.

[0042] Further details of the docking device delivery apparatus, and variations thereof, are described in US Patent Application Publication No. 2007 / 0129994, the entirety of which is incorporated herein by reference.

[0043] 2A , after the guide catheter 30 is positioned within the left atrium 18, the user may 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 embodiments, the guidewire 40 may be at least partially retracted into the guide catheter 30, away from the left atrium 18. The user may then continue to advance the delivery shaft 54 ​​of the docking device delivery device 50 along the guidewire 40 and through the blood vessel 12 until the delivery shaft 54 ​​reaches the left atrium 18, as illustrated in FIG. 2A . Specifically, the user may grasp the handle 56 of the docking device delivery device 50 toward the patient 10 and apply force (e.g., pushing) to advance the delivery shaft 54 ​​of the docking device delivery device 50. While advancing the delivery shaft 54 ​​through the blood vessel 12 and the heart 14, the user may adjust one or more articulation members 57 of the handle 56 to navigate various turns, corners, narrowings, and / or other obstacles within the blood vessel 12 and the heart 14.

[0044] After the delivery shaft 54 ​​reaches the left atrium 18 and protrudes from the distal end of the guide catheter 30, the user can use the handle 56 (e.g., articulation member 57) to position the distal end portion 53 of the delivery shaft 54 ​​at and / or near the posterior commissure of the native mitral valve 16. The user can then push the docking device 52 out of the distal end portion 53 of the delivery shaft 54 ​​with the shaft of the pusher assembly 58 to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0045] In some embodiments, the docking device 52 may be constructed from, formed from, and / or include a shape memory material such that it returns to its original pre-formed shape upon exiting the delivery shaft 54 ​​and thus being released from constraint by the delivery shaft 54. As one example, the docking device 52 may be originally formed as a coil, and thus may wrap around the leaflets 24 of the native mitral valve 16 upon exiting the delivery shaft 54 ​​and returning to its original coiled configuration.

[0046] After pushing in the ventricular portion of the docking device 52 (e.g., the portion of the docking device 52 shown in FIG. 2A configured to be positioned within the left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user may deploy the remainder 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 posterior commissure of the native mitral valve 16.

[0047] After the docking device 52 is deployed and implanted at the native mitral valve 16, the user may disconnect the docking device delivery apparatus 50 from the docking device 52. After the docking device 52 is disconnected from the docking device delivery apparatus 50, the user may retract the docking device delivery apparatus 50 from the blood vessel 12, away from the patient 10, allowing the user to deliver and implant the prosthetic heart valve 62 in the implanted docking device 52 at the native mitral valve 16.

[0048] 2B illustrates this stage in the mitral valve replacement procedure, where the docking device 52 is fully deployed and implanted at the native mitral valve 16 and the docking device delivery apparatus 50 (including the delivery shaft 54) is removed from the patient 10, leaving only the guidewire 40 and guide catheter 30 within the patient 10. In some examples, after removing the docking device delivery apparatus, the guidewire 40 may be advanced out of the guide catheter 30, through the docking device 52 implanted at the native mitral valve 16, and into the left ventricle 26 ( FIG. 2A ). As such, the guidewire 40 may help guide the prosthetic valve delivery apparatus 60 at least partially through the annulus of the native mitral valve 16 and into the left ventricle 26.

[0049] 2B, the docking device 52 can include multiple 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 compared to the annulus of the native mitral valve 16, thereby providing a closer conformance to the shape or profile of the prosthetic heart valve into which it is to be implanted. As a result, the docking device 52 can be fitted more tightly between the prosthetic heart valve and the native mitral valve 16, as described further below, thereby providing a better seal between the prosthetic heart valve and the native mitral valve 16.

[0050] FIG. 3A shows another stage in a mitral valve replacement procedure, in which a user is using a prosthetic valve delivery apparatus 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," "replacement heart valve," and / or "prosthetic mitral valve") into a docking device 52.

[0051] 3A , the prosthetic valve delivery apparatus 60 can 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 patient's vasculature 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 for advancing the delivery shaft 64 through the patient's vasculature.

[0052] In some embodiments, the handle 66 may include one or more articulation members 68 configured to assist in steering the delivery shaft 64 through the blood vessel 12 and the heart 14. Specifically, the articulation members 68 may include one or more knobs, buttons, wheels, and / or other types of physically adjustable control members configured to be adjusted by a user to bend, curve, twist, rotate, and / or otherwise articulate a distal end portion of the delivery shaft 64 to assist in steering the delivery shaft 64 through the blood vessel 12 and into the left atrium 18 and into the left ventricle 26 of the heart 14.

[0053] In some examples, the prosthetic valve delivery apparatus 60 can include an expansion mechanism 65 configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some instances, as shown in FIG. 3A , the expansion mechanism 65 can include an inflatable balloon configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon can be coupled to a distal end portion of the delivery shaft 64.

[0054] In other examples, the prosthetic heart valve 62 may be self-expanding and configured to radially expand on its own upon removal of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal end portion of the delivery shaft 64. In yet other examples, the prosthetic heart valve 62 may be mechanically expandable, and the prosthetic valve delivery device 60 may include one or more mechanical actuators (e.g., expansion mechanisms) configured to radially expand the prosthetic heart valve 62.

[0055] As shown in FIG. 3A, the prosthetic heart valve 62 is mounted on the distal end portion of the delivery shaft 64 around an expansion mechanism 65 (an inflatable balloon) in a radially compressed configuration.

[0056] To steer the distal end portion of the delivery shaft 64 to the implantation site, a user can insert the prosthetic valve delivery device 60 (delivery shaft 64) through the guide catheter 30 and over the guidewire 40 into the patient 10. The user can continue to advance the prosthetic valve delivery device 60 along the guidewire 40 (through the blood vessel 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as shown in FIG. 3A . More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery device 60 by grasping the handle 66 and applying force (e.g., pushing) on ​​the handle 66. While advancing the delivery shaft 64 through the blood vessel 12 and the heart 14, the user can negotiate various turns, corners, stenoses, and / or other obstacles within the blood vessel 12 and the heart 14 by adjusting one or more articulation members 68 of the handle 66.

[0057] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and within the native mitral valve 16. In some examples, as shown in FIG. 3A , 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.

[0058] Once the radially compressed prosthetic heart valve 62 is properly positioned within the docking device 52 (FIG. 3A), the user can manipulate one or more actuation mechanisms on the handle 66 of the prosthetic valve delivery apparatus 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.

[0059] 3B shows another stage in the mitral valve replacement procedure, in which the prosthetic heart valve 62 is in its radially expanded configuration and is implanted within the docking device 52 of the native mitral valve 16. As shown in FIG. 3B, the prosthetic heart valve 62 is received and held 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 may enable a better seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16, thereby reducing paravalvular leakage around the prosthetic heart valve 62.

[0060] Also, as shown in FIG. 3B, after the prosthetic heart valve 62 is 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, thereby leaving only the guidewire 40 and the guide catheter 30 inside the patient 10.

[0061] FIG. 4 shows another stage in the mitral valve replacement procedure, in which the guidewire 40 and guide catheter 30 have been removed from the patient 10.

[0062] 1-4 specifically illustrate mitral valve replacement, it should be understood that the same and / or similar procedures may be utilized to replace other heart valves (e.g., tricuspid, pulmonary, and / or aortic valves). Furthermore, 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 may be utilized to replace these other heart valves.

[0063] For example, if replacing a native tricuspid valve, a user may also access the right atrium 20 via the femoral vein, but would not need to cross the atrial septum 22 into the left atrium 18. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation process 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 leaflets, release the remainder of the docking device 52 from the delivery shaft 54 ​​in the right atrium 20, and then remove the delivery shaft 54 ​​of the docking device delivery apparatus 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 process 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 / placed within the docking device 52 and tricuspid valve. The user may then expand the prosthetic heart valve 62 within the docking device 52, after which the prosthetic valve delivery device 60 may be removed from the patient 10. In another example, the user may perform the same and / or similar process to replace the aortic valve, but access the aortic valve from the outflow side of the aortic valve via the femoral artery.

[0064] 1-4 illustrate a mitral valve replacement procedure in which the native mitral valve 16 is accessed from the left atrium 18 via the right atrium 20 and the femoral vein, it should be understood that the native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, a user may access the native mitral valve 16 from the left ventricle 26 through the aortic valve by advancing one or more delivery devices through an artery to the aortic valve, and then through the aortic valve into the left ventricle 26.

[0065] Figure 5 illustrates docking device 52 in more detail. As illustrated in Figure 5, docking device 52 in a deployed configuration can be configured to receive and secure a prosthetic valve therein, thereby securing the prosthetic valve at the native valve annulus.

[0066] The docking device 52 can include a coil 72 and an optional guard member 74 that covers at least a portion of the coil 72. In certain embodiments, the coil 72 can include a shape memory material (e.g., a nickel-titanium alloy, or "nitinol") such that the docking device 52 (and the coil 72) can transition from a substantially straight configuration (or delivery configuration) when disposed within the delivery shaft 54 ​​of the delivery apparatus 50 to a spirally deployed configuration after being removed from the delivery shaft 54.

[0067] 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 positioned 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., no coiled or looped portions are present, but the coil can bend or curve) to maintain a low radial profile during movement through the patient's vasculature. After removal from the delivery shaft 54 ​​and deployment at the implantation location, the coil 72 can transition from the delivery configuration to a helical deployed configuration and wrap around native tissue adjacent the implantation location. For example, when implanting the docking device at the location of a native valve, the coil 72 can be configured to surround the native valve leaflets (and, if present, the chordae tendineae connecting the native leaflets to the adjacent papillary muscles) of the native valve.

[0068] The docking device 52 can be removably coupled to the docking device delivery apparatus 50. For example, in certain embodiments, the docking device 52 can be coupled to the delivery apparatus (such as those described above) via release sutures that can be coupled to the docking device 52 and configured to be cut for removal.

[0069] As shown in FIG. 5 , the deployed configuration of the coil 72 can include, about a central longitudinal axis, a leading turn 76 (or “leading coil”), a central region 78, and a stabilizing turn 80 (or “stabilizing coil”). The central region 78 can have one or more helical turns having substantially equal inner diameters. The leading turn 76, in the illustrated embodiment, can extend from a distal end of the central region 78 and has a diameter larger than the diameter of the central region 78. The stabilizing turn 80, in the illustrated embodiment, can extend from a proximal end of the central region 78 and has a diameter larger than the diameter of the central region 78.

[0070] Further details regarding docking devices and variations thereof are described in US Pat. No. 6,223,999, which is incorporated herein by reference in its entirety.

[0071] 6A illustrates a delivery apparatus 200 configured to implant a docking device, such as docking device 52 (FIG. 5) or other docking devices, to a target implantation site within a patient, according to one embodiment. For example, delivery apparatus 200 can be used as docking device delivery apparatus 50 in a prosthetic valve implantation procedure, as described above with reference to FIG. 2A. Delivery apparatus 200 can also be referred to as a "docking device delivery apparatus," a "dock delivery catheter," or a "dock delivery system."

[0072] As shown, 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 handle assembly 202. Handle assembly 202 can include a first or main handle 206 that can include one or more knobs, buttons, wheels, and / or other means for controlling and / or actuating one or more components of delivery device 200. For example, in some embodiments, as shown in FIG. 6A , main handle 206 can include knobs 208 and 210 that can be configured to steer or control deflection of delivery device 200, such as delivery shaft 204 and / or sleeve shaft 220, as described below.

[0073] In certain embodiments, the delivery device 200 can also include a pusher shaft 212 and a sleeve shaft 220, both of which can extend through the lumen of the delivery shaft 204 and can have respective proximal end portions that extend into the handle assembly 202.

[0074] As described below, the distal end portion (also referred to as the "distal section") of the sleeve shaft 220 can be configured to cover (e.g., surround) the docking device 52 (see FIG. 5). For example, the distal end portion of the sleeve shaft 220 can comprise a generally tubular structure. The docking device 52 can be retained within the sleeve shaft 220, which is further retained by the distal end portion 205 of the delivery shaft 204, as it is threaded through the patient's vasculature.

[0075] Additionally, the distal end portion 205 of the delivery shaft 204 can be configured to be steerable. In one embodiment, by rotating a knob (e.g., 208 or 210) on the main handle 206, the curvature of the distal end portion 205 of the delivery shaft 204 can be adjusted so that the distal end portion 205 can be oriented at a desired angle. For example, to implant the docking device 52 at the location of the native mitral valve, the distal end portion 205 of the delivery shaft 204 can be steered within the left atrium so that at least a portion of the sleeve shaft 220, with the docking device 52 held therein, can extend through the native mitral valve annulus at a location adjacent the posterior commissure.

[0076] In certain examples, the pusher shaft 212 and the sleeve shaft 220 can be coaxial with one another, at least within the delivery shaft 204. Additionally, the delivery shaft 204 can be configured to be axially movable relative to the sleeve 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 sleeve shaft 220 and can press against the proximal end of the docking device 52 held within the sleeve shaft 220.

[0077] 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 sleeve shaft 220 using the dock handle 218 (also referred to as a “second handle” or “hub assembly”), as described further below. For example, the docking device 52 can be pushed out of the distal end 204d of the delivery shaft 204 by pushing the pusher shaft 212 distally while holding the delivery shaft 204 in place, or by retracting the delivery shaft 204 proximally while holding the pusher shaft 212 in place, or by pushing the pusher shaft 212 distally while simultaneously retracting the delivery shaft 204 proximally, thereby allowing the docking device 52 to transition from the delivery configuration to the deployed configuration (see FIG. 5 ). In certain examples, the pusher shaft 212 and the sleeve shaft 220 can be actuated independently of one another.

[0078] During delivery, the docking device 52 can be coupled to the delivery apparatus 200 via a release suture 222 (see FIG. 6B ) that extends through the pusher shaft 212 or other retrieval line including a string, yarn, or other material that can be configured to be tied around the docking device 52 and cut for removal. In one specific example, the release suture 222 can extend through the delivery apparatus 200, for example, through a lumen of the pusher shaft 212, to the suture lock assembly 216 of the delivery apparatus 200.

[0079] The handle assembly 202 may further include one or more irrigation ports (e.g., irrigation port 232 is shown in FIG. 6A and irrigation port 234 is shown in FIGS. 6A-6B) for supplying irrigation fluid to one or more lumens disposed within the delivery device 200 (e.g., annular lumens disposed between coaxial components of the delivery device 200), for example, to maintain hemostasis within the delivery device 200.

[0080] Further details regarding delivery apparatus / catheters / systems (including various embodiments of handle assemblies) configured to deliver docking devices to target implantation sites can be found in U.S. Patent Nos. 5,627,297; 5,627,297; 5,627,297; and 5,627,297, each of which is incorporated herein by reference in its entirety.

[0081] As described above, the handle assembly 202 can further include a dock handle 218 to which the suture lock assembly 216 and the sleeve handle 224 are attached. The dock handle 218 can be configured to independently control the pusher shaft 212 and the sleeve shaft 220. The sleeve handle 224 can be coupled to the proximal end of the sleeve shaft 220 and control the axial position of the sleeve shaft 220 relative to the pusher shaft 212. In this manner, operation of various components of the handle assembly 202 can actuate and control operation of components disposed within the delivery shaft 204. In some embodiments, the dock handle 218 can be coupled to the main handle 206 via a connector 226.

[0082] 6B shows in more detail an embodiment of a dock handle 218 of the handle assembly 202. In some embodiments, as shown, the dock handle 218 may 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 branch conduit), although in some embodiments, the dock handle 218 may include two or more branches.

[0083] The dock handle 218 may be adapted and configured such that a proximal segment 238 of the pusher shaft 212 (or another similar pusher shaft) is extendable to the suture lock assembly 216 disposed at the end of the bifurcation 236, while a proximal portion 240 of the sleeve shaft 220 extends to the sleeve handle 224 disposed at the proximal end of the straight section 230 (see also FIG. 7 ). With this configuration, a medical professional may effect deployment of a docking device (e.g., docking device 52 of FIG. 5 ) by manipulating (e.g., axially moving) the position of the dock handle 218, and may effect retraction of the sleeve shaft 220 (disengage from and away from the implanted docking device) by pulling back axially on the sleeve handle 224.

[0084] In this manner, the sleeve shaft 220 and the pusher shaft 212 can be configured to function together such that they can be moved together simultaneously when deploying and positioning the docking device at the native valve (e.g., by moving the entire dock handle 218 axially forward and / or backward), but also independently movable so that the pusher shaft 212 can hold the docking device in place while the sleeve shaft 220 is retracted away from the docking device (e.g., by holding the dock 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 docking device while pulling proximally on the sleeve handle 224 to remove the sleeve shaft 220).

[0085] As shown in FIG. 7 , the proximal portion 240 of the sleeve shaft 220 has an outer surface 242 including an inwardly facing surface 244 and an outwardly facing surface 246. The inwardly facing surface 244 may define an open channel. For example, the channel of the sleeve shaft 220 is radially open such that the proximal segment 238 of the pusher shaft 212 may extend out of the open channel and away from the sleeve shaft 220 at an angle (e.g., through the bifurcation 236) relative to the longitudinal axis 225 of the sleeve shaft 220 ( FIG. 23 ). In some embodiments, the proximal portion 240 of the sleeve shaft 220 may also be referred to herein as the “open channel 240.”

[0086] As shown in FIG. 7 , open channel 240 can have a generally U- or C-shaped cross-section. In some embodiments, as shown, outer surface 242 is curved such that open channel 240 has a partially annular cross-section (e.g., a C-shaped cross-section). Specifically, open channel 240 may be partially annular such that inwardly facing surface 244 is concave and outwardly facing surface 246 is convex. An edge surface or lip 248 may define the junction between concave (or inwardly facing) surface 244 and convex (or outwardly facing) surface 246. In this manner, inwardly facing surface 244 of open channel 240 can form a void space in which pusher shaft 212 can be at least partially disposed ( FIG. 7 ). In various embodiments, open channel 240 can be cut using a laser (e.g., to form lip 248), although any other means for forming an open channel (e.g., removing a portion of a tubular structure) can be used.

[0087] The distal segment 250 of the sleeve shaft 220 may include a closed channel or lumen such that the channel is radially closed (e.g., annular cross-section) (FIG. 6A). The pusher shaft 212 may extend through the closed channel of the distal segment 250. For example, the pusher shaft 212 may be coaxial with the sleeve shaft 220 along some or most of the delivery device 200, such as through the distal segment 250 of the sleeve shaft 220. The distal segment 250 may extend from the distal end of the sleeve shaft 220 to the open channel 240, e.g., at a mid-axial position of the sleeve shaft 220. The open channel 240 of the sleeve shaft 220 may extend from a mid-axial position of the sleeve shaft 220 to the proximal end of the sleeve shaft 220, e.g., to the sleeve handle 224. In other examples, the open channel 240 of the sleeve shaft 220 may extend proximally from a mid-axial position without extending to the proximal end of the sleeve shaft 220. In these embodiments, 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 and away from the sleeve shaft 220 at an angle.

[0088] The dock handle 218 can include, for example, a seal housing 252 disposed at a proximal end portion of the straight section 230. In some embodiments, the housing of the dock handle 218 can include or define a portion of the seal housing 252. In some embodiments, the seal housing 252 can be formed separately from and coupled to the housing of the dock handle 218, as shown in FIG.

[0089] The seal housing 252 can house various gaskets, seals, and / or washers to form a seal around the open channel 240 of the sleeve shaft 220. For example, FIGS. 8 and 9 show 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 sleeve shaft 220. In some embodiments, as shown in FIGS. 6A-6B , the locking knob 254 can be coupled to the seal housing 252 via, for example, 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 apply sufficient pressure to the hemostatic seal 2400 to actively seal the open channel 240 of the sleeve shaft 220 as well as lock the sleeve shaft 220 so that the sleeve shaft 220 is prevented from moving relative to the dock handle 218. In the unlocked configuration, this pressure is removed from the hemostatic seal 2400 such that the sleeve shaft 220 is permitted to move relative to the dock handle 218. In some instances, in the unlocked configuration, the seal 2400 may not actively seal against the sleeve shaft 220 and / or may not provide hemostasis. In this manner, the hemostatic seal 2400 may be considered an active seal.

[0090] As seen in FIG. 8 , the hemostatic seal 2400 can have an opening 2406 within the cross-sectional shape of the open channel 240 of the sleeve shaft 220, such as a U-shape, a C-shape, or an incomplete (e.g., partial) annulus, configured to receive the open channel 240 therein and seal all sides of the sleeve shaft 220 (e.g., faces 244, 246 and edge 248). FIG. 9 shows one embodiment of the hemostatic seal 2400 disposed within a portion of the seal housing 252. In FIG. 9 , the seal 2400 and a portion of the seal housing 252 are transparent, and the locking knob 254 has been omitted for illustrative purposes. In some embodiments, as shown in FIG. 9 , two hard washers 2402 and 2404 can support each end of the hemostatic seal 2400. The hard washers 2402, 2404 can have the same contour as the hemostatic seal 2400 to maintain the integrity of the hemostatic seal 2400. In the locked configuration, the rigid washers 2402, 2404 can exert inward pressure on the hemostatic seal 2400 to ensure a seal between the hemostatic seal 2400 and the open channel 240 of the sleeve shaft 220 based on contact between the locking knob 254 and the proximal washer 2402.

[0091] In some embodiments, it may be desirable for the sleeve shaft 220 to be sealed regardless of the locked state of the sleeve shaft 220. For example, it may be desirable to seal the sleeve shaft 220 with a passive seal that allows a hemostatic seal around the sleeve shaft 220 while the sleeve shaft 220 is free to move relative to the handle assembly 202, rather than a seal that is selectively active (e.g., actively seals in a locked configuration). In other words, the passive hemostatic seal may be present around the sleeve shaft 220 regardless of whether the sleeve shaft 220 is locked or unlocked. In these embodiments, a locking mechanism may be used to secure the sleeve shaft 220 relative to the handle assembly 202 that operates independently of the hemostatic seal of the sleeve shaft 220. For example, the locking mechanism may include a structure other than the locking knob 254, such as a collet, clamp, or the like, configured to apply frictional and / or compressive forces to the sleeve shaft 220 to prevent movement of the sleeve shaft 220 relative to the handle assembly 202. In some embodiments, the locking mechanism may be spaced and / or proximal to the seal of the sleeve shaft 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.

[0092] 10-15 illustrate one embodiment of a hemostatic seal 100 that passively seals the open channel 240 of the sleeve shaft 220 and may be disposed within a seal housing 252. For example, the seal 100 may provide hemostasis during relative movement between the sleeve shaft 220 and the seal 100. The passive hemostatic seal 100 may provide sufficient sealing force to the sleeve shaft 220 independent of a locking mechanism on the sleeve shaft 220, for example, based on a compressive force applied to the seal 100 (e.g., by the seal housing 252).

[0093] As shown, the hemostatic seal 100 includes multiple sealing members for sealing around the open channel 240 within the seal housing 252. Specifically, the hemostatic seal 100 includes a first (or outer) sealing member 102 and a second (or inner) sealing member 104 coupled to the outer sealing member 102. The outer sealing member 102 and the inner sealing member 104 are coupled together in a manner that forms a seal therebetween. The outer sealing member 102 can be configured to seal around at least the 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 the inward-facing surface 244 of the open channel 240. For example, the inner sealing member 104 may seal a second gap between the inwardly facing surface 244 and the inner wall 256 of the seal housing 252 .

[0094] In some instances, seal housing 252 may be integrally formed as a single, unitary component. In other instances, as shown in FIGS. 10 and 14-15, seal housing 252 may comprise one or more segments formed as separate components that are coupled together (e.g., via fasteners, adhesive, mating features, and / or other means for coupling). For example, seal housing 252 may comprise first or upper segment 252a and second or lower segment 252b coupled together via mating features (e.g., pin 260 and socket connection (FIG. 15)). In other examples, as shown in FIGS. 16-17, seal housing 252 may include distal segment 252d and proximal segment 252p (e.g., instead of upper segment 252a and lower segment 252b). In some examples, seal housing 252 may be manufactured using one or more molding processes (e.g., injection molding, etc.).

[0095] 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 sleeve shaft 220, the hemostatic seal 100 creates a passive hemostatic seal around the sleeve shaft 220. For example, the seal housing 252 can provide sufficient compression to the hemostatic seal 100 such that the open channel 240 of the sleeve shaft 220 is sealed while the sleeve shaft 220 is free to move relative to the dock handle 218. In addition to the inner wall 256, the chamber of the seal housing 252 can be defined by one or more inner surfaces of the seal housing 252, including a distal surface 262 and a proximal surface 264 ( FIG. 10 ). As shown, hemostatic seal 100 may be positioned between distal surface 262 and proximal surface 264 and compressed within the chamber of seal housing 252 (e.g., by inner wall 256, by wedge 258, and / or by distal surface 262 and proximal surface 264). In this manner, hemostatic seal 100 creates a passive hemostatic seal around sleeve shaft 220, including while sleeve shaft 220 is moving relative to seal 100, seal housing 252, and / or dock handle 218 (e.g., regardless of the locked or unlocked state of sleeve shaft 220).

[0096] The outer sealing member 102 includes an inner surface 106 that defines an opening 108 extending therethrough. The opening 108 extends from a first end 110 to a second end 112 of the sealing member 102, and the sleeve shaft 220 can extend through the opening 108. In some embodiments, the inner surface 106 can include a first or flat portion 106a and a second or curved portion 106b such that the opening 108 is D-shaped, as shown (FIG. 13A). As shown, the second portion 106b can generally correspond to and be complementary in shape to the outwardly facing surface 246. For example, the second portion 106b can be an inwardly facing surface (e.g., concavely curved, etc.). When external sealing member 102 is disposed around sleeve shaft 220, second portion 106b contacts outwardly facing surface 246 of open channel 240 and can have the same or substantially the same radius of curvature as outwardly facing surface 246. In this manner, curved portion 106b can seal against and / or around outwardly facing surface 246 when sleeve shaft 220 is disposed within opening 108. In some embodiments, flat portion 106a can contact and seal against and / or around edge 248 of open channel 240. In this manner, external sealing member 102 can create a seal around the outer surface of open channel 240 (e.g., outwardly facing surface 246 and, in some embodiments, edge 248). In other embodiments, the inner surface 106 may define openings having other shapes that engage with at least the outwardly facing surface 246 of the sleeve shaft 220, including circular openings, square or rectangular openings (e.g., for a U-shaped sleeve shaft 220), etc.

[0097] In some embodiments, the outer sealing member 102 is generally cylindrical with a stepped outer surface 114. The outer surface 114 may 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 may be sized to fit within the chamber of the seal housing 252 such that the outer sealing member 102 contacts the inner walls 256 of both the upper and lower segments 252a and 252b. In this manner, the first outer surface portion 114a may seal a first gap between the inner wall 256 of the seal housing 252 and the outward-facing surface 246 of the sleeve shaft 220.

[0098] The outer diameter of the second outer surface portion 114b may 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 between the first end 110 and the second end 112 that defines a transition between the first outer surface portion 114a and the second outer surface portion 114b.

[0099] The inner sealing member 104 includes an inner surface 118 that defines an opening 120 through which the sleeve shaft 220 can extend. In some embodiments, the inner surface 118 may be stepped and may have a first inner surface portion 118a adjacent the first end 122 of the inner sealing member 104 and a second inner surface portion 118b adjacent the second end 124 of the inner sealing member 104. The inner diameter of the first inner surface portion 118a may be sized to receive the second outer surface portion 114b of the outer sealing member 102 such that the first inner surface portion 118a of the inner sealing member 104 contacts the second outer surface portion 114b of the outer sealing member 102 when the sealing members 102, 104 are coupled together. In some embodiments, the first inner surface portion 118a may define a larger opening than the second inner surface portion 118b. For example, the radius of curvature of second inner surface portion 118b may be smaller than the radius of curvature of first inner surface portion 118a. In the illustrated example, the radius of curvature of second inner surface portion 118b may be equal to or approximately equal to the radius of curvature of outwardly facing surface 246 of open channel 240. Inner surface 118 of inner sealing member 104 may include a lip 126 positioned axially between first end 122 and second end 124 that defines a transition between first inner surface portion 118a and second inner surface portion 118b.

[0100] As described above, the outer sealing member 102 and the inner sealing member 104 can be coupled or fitted together such that a seal is formed between the sealing members 102, 104. For example, the sealing members 102, 104 can partially overlap radially and axially. In some embodiments, as shown, the inner sealing member 104 can be partially disposed 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 over 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, the first inner surface portion 118a (the inner surface of the extension 128) can contact the second outer surface portion 114b when the outer sealing member 102 and the inner sealing member 104 are fitted together. As shown in FIG. 12B, the extension 128 and the first inner surface portion 118a have a shape (eg, annular) that corresponds to the shape of the second outer surface portion 114b of the sealing member 102.

[0101] The second end 112 of the outer sealing member 102 can contact the lip 126 and / or the inner protrusion 130 of the inner sealing member 104. In some embodiments, as shown, the lip 126 and the inner protrusion 130 can define a first intermediate surface 132 that is parallel to the first end 122 of the inner sealing member 104 ( FIG. 12B ). The first intermediate surface 132 is axially disposed between the first end 122 and the second end 124 of the inner sealing member 104. When the outer sealing member 102 and the inner sealing member 104 are mated together, the second end 112 of the outer sealing member 102 can contact the first intermediate surface 132, and the first end 122 of the inner sealing member 104 can contact the shoulder 116 of the outer sealing member 102. For example, the axial distance between the first intermediate surface 132 and the first end 122 of the inner sealing member 104 may be equal to the axial distance between the shoulder 116 and the second end 112 of the outer sealing member 102. In other words, the first inner surface portion 118a of the inner sealing member 104 and the second outer surface portion 114b of the outer sealing member 102 may be the same length.

[0102] The lip 126 can define a step along the inner surface 118 of the inner sealing member 104. In this manner, the first inner surface portion 118a can contact the second outer surface portion 114b of the outer sealing member 102, which can contact the outwardly facing surface 246 of the open channel 240 when the sleeve shaft 220 is disposed within the hemostatic seal 100. In some embodiments, the height of the lip 126 can be smaller (e.g., the height is smaller than shown in FIG. 10 ) or the lip 126 can be omitted so that a portion of the inner surface of the inner sealing member 104 does not contact the sleeve shaft 220 (e.g., relying on the outer sealing member 102 to seal the gap between the seal housing 252 and the outwardly facing surface 246 of the sleeve shaft 220).

[0103] In some embodiments, the sealing members 102, 104 may fit together in other manners and / or using different structures than the shoulder 116 and extension 128. For example, rather than the outer sealing member 102 having a reduced outer diameter size that fits within the inner sealing member 104, the inner sealing member 104 may 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 may have a continuous outer diameter, and the inner surface 106 defining the opening 108 may be stepped such that the extension of the inner sealing member 104 may be positioned within the opening 108 and abut a shoulder or lip therein. Thus, in some embodiments, the outer sealing member 102 may be positioned partially around the inner sealing member 104.

[0104] In some embodiments, as shown, the first end 110 of the outer sealing member 102 may contact the distal surface 262 of the seal housing 252, and the second end 124 of the inner sealing member 104 may contact the proximal surface 264 of the seal housing 252. In other embodiments, the hemostatic seal 100 may be oriented differently, such that the first end 110 of the outer sealing member 102 may contact the proximal surface 264, and the second end 124 of the inner sealing member 104 may contact the distal surface 262.

[0105] The sealing members 102, 104 may have a lower durometer than the seal housing 252 and the sleeve shaft 220. For example, the sealing members 102, 104 may be relatively softer and / or more flexible than the seal housing 252 and the sleeve shaft 220 such that the sealing members 102, 104 can be compressed against the inner surface of the seal housing 252 and about the surface of the sleeve shaft 220 to create a hemostatic seal about the sleeve shaft 220 within the seal housing 252.

[0106] The inner protrusion 130 of the inner sealing 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 sealing member 104 in a direction perpendicular to the longitudinal axis of the inner sealing member 104 (and perpendicular to the longitudinal axis 225 of the sleeve shaft 220). When the sleeve shaft 220 is disposed 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 be complementary to the shape of the inward-facing surface 244. For example, the engagement surface 134 can have an outward-facing surface (e.g., a convex curve, etc.). In this manner, the inner protrusion 130 may extend or protrude into the opening defined by the open channel 240 and the engagement surface 134 may seal against the inwardly facing surface 244 .

[0107] To ensure an adequate seal between engagement surface 134 of inner protrusion 130 and inwardly facing surface 244 of sleeve shaft 220, inner protrusion 130, or a portion thereof, may comprise a different material than the remainder of inner sealing member 104 and / or outer sealing member 102. In some examples, the material may be harder and / or more rigid to enhance the structural integrity of the inner protrusion. In some examples, the material may be a material with a lower durometer (e.g., more compressible) to provide better sealing capabilities.

[0108] In some embodiments, a more rigid component can be positioned at least partially within the internal projection 130 to ensure an adequate seal between the engagement surface 134 of the internal projection 130 and the inward-facing surface 244 of the sleeve shaft 220. For example, a relatively hard or rigid component can enhance the structural integrity of the internal projection 130 so that the internal projection 130 applies sufficient sealing force to the inward-facing surface 244. In some embodiments, a separate structure or component can be disposed within an opening or slot in the internal projection 130.

[0109] To accommodate relatively rigid components, inner protrusion 130 may include a slot 136 extending along the axial length of inner protrusion 130. For example, slot 136 may extend from second end 124 to a second intermediate surface 138 ( FIGS. 11 and 13B ) axially disposed between first end 122 and second end 124 of inner sealing member 104. As shown, second intermediate surface 138 is located at or adjacent lip 126.

[0110] In some embodiments, at least a portion of seal housing 252 may extend or protrude radially inward from inner wall 256. When inner sealing member 104 is positioned within seal housing 252, this portion of seal housing 252 may extend into slot 136. For example, seal housing 252 may include a protrusion or wedge 258 configured to extend into slot 136 to ensure that inner sealing member 104 contacts and / or expands against inward-facing surface 244 of open channel 240. Prior to positioning wedge 258 within slot 136, components (e.g., sleeve shaft 220) can move freely relative to seal 100, which may provide advantages in the assembly process. After components are positioned relative to seal 100, seal 100 may be activated by positioning wedge 258 within slot 136 (e.g., at the end of the assembly process). 10, the upper segment 252a can include a wedge 258 (see also FIG. 15). In other embodiments, other segments of the seal housing 252 (such as, for example, the distal segment 252d of the seal housing 252) can include a wedge 258.

[0111] As shown in FIG. 13B , which shows an end view of the inner sealing member 104, the inner protrusion 130 defines two openings extending axially through the inner sealing member 104. The open channel 240 may extend through the lower opening 120, and the wedge 258 may extend radially into the upper opening 121 defined by the slot 136. Specifically, when the inner sealing member 104 is disposed within the seal housing 252, the wedge 258 is positioned with the upper opening 121 and contacts the slot 136. In this manner, the wedge 258 may 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 inward-facing surface 244 of the open channel 240. In some embodiments, the shape of the slot 136 may correspond to the shape of the wedge 258 (e.g., have a constant width; see FIGS. 11 and 12B ). 13B and 14, the slot 136 may be tapered or stepped such that the slot 136 is wider nearer the outer surface of the inner sealing member 104 and narrower toward the lower end of the slot 136. In these embodiments, the wedge 258 may stretch or expand the narrow portion of the slot 136 radially outward relative to the inward-facing surface 244 of the open channel 240.

[0112] Slot 136 is shown as an axially through slot, such that first intermediate surface 132 and second end 124 of inner sealing member 104 define an open end of slot 136. In some embodiments, rather than slot 136 being a through slot having opening 121 extending through first intermediate surface 132 and second end 124, slot 136 may extend less than the entire axial length of inner protrusion 130. For example, the ends of slot 136 may be spaced apart from first intermediate surface 132 and / or second end 124 of inner sealing member 104 such that slot 136 opens only radially through the outer surface of inner sealing member 104.

[0113] Inner protrusion 130 may also be configured to seal against edge 248 of open channel 240. For example, inner protrusion 130 may include flat, axially extending surfaces 140, 142 disposed on either side of engagement surface 134 that seals against edge 248. Second inner surface portion 118b, engagement surface 134, and surfaces 140, 142 may define opening 120 at second end 124 of inner sealing member 104. At first end 122 of inner sealing member 104, opening 120 is defined by first inner surface portion 118a. In this manner, opening 120 has a different shape at first end 122 of inner sealing member 104 (e.g., corresponding to the shape of second end 112 of outer sealing member 102) than at second end 124 of inner sealing member 104 (e.g., corresponding to the shape of open channel 240 of sleeve shaft 220).

[0114] In some embodiments, a passive hemostatic seal may include a single sealing member rather than multiple sealing members. FIGS. 16-20 illustrate one embodiment of a hemostatic seal 300 that passively seals open channel 240 of sleeve shaft 220 and may be disposed within seal housing 252. As shown, hemostatic seal 300 includes a sealing member 302 for sealing around open channel 240 and a seal block 304 coupled to sealing member 302. Sealing member 302 may be configured to seal open channel 240 within the chamber of seal housing 252 (e.g., between open channel 240 and interior wall 256). Seal block 304 may be configured to expand and / or compress a portion of sealing member 302 against at least the inward-facing surface 244 of open channel 240, similar to, for example, wedge 258 of seal housing 252.

[0115] In some embodiments, seal block 304 may be used instead of and / or in addition to wedge 258. For example, as shown in FIGS. 16-17 , seal housing 252 does not include wedge 258. As described above, in some embodiments, seal housing 252 may include first or distal segment 252d and second or proximal segment 252p coupled to first segment 252d. For example, second segment 252p may be a cap fitted around and secured to the proximal end of first segment 252d. In the illustrated embodiment, first segment 252d includes distal surface 262 and inner wall 256, and second segment 252p includes proximal surface 264.

[0116] As shown, hemostatic seal 300 is positioned between distal surface 262 and proximal surface 264 and may be compressed within the chamber of seal housing 252 (e.g., by interior wall 256 and / or by distal surface 262 and proximal surface 264). In this manner, hemostatic seal 300 creates a passive hemostatic seal about sleeve shaft 220, including while sleeve shaft 220 is moving relative to seal 300, seal housing 252, and / or dock handle 218 (e.g., regardless of the locked or unlocked state of sleeve shaft 220). Although hemostatic seal 300 is shown as being positioned within seal housing 252 having distal and proximal segments, hemostatic seal 300 may be disposed within any seal housing (e.g., any of the seal housings described herein, seal housings having upper and lower segments, etc.).

[0117] Figure 16 shows a cross-sectional view of hemostatic seal 300 disposed within the chamber of seal housing 252. Figure 17 illustrates hemostatic seal 300 within seal housing 252 with second segment 252p removed for illustrative purposes. Figures 18A-18D show multiple views of sealing member 302. Figures 19-20 show hemostatic seal 300 disposed around open channel 240 of sleeve shaft 220.

[0118] 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 a first end 310 of the sealing member 302 and is configured to seal around and / or against at least the outwardly facing surface 246 of the open channel 240. For example, the outer sealing portion 306 can seal a first gap between the outwardly facing surface 246 and an inner wall 256 of the seal housing 252. The inner sealing portion 308 is adjacent a second end 312 of the sealing member 302 and is configured to seal around and / or against at least the inwardly facing surface 244 of the open channel 240. For example, the inner sealing portion 308 can seal a second gap between the inwardly facing surface 244 and the inner wall 256 of the seal housing 252.

[0119] As shown in FIGS. 18A-18D , the outer sealing portion 306 includes an inner surface 314 defining an opening 316 extending axially through the outer sealing portion 306 from a 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 sealing member 302 (e.g., perpendicular to the longitudinal axis of the sealing member 302). In some examples, as shown, the inner surface 314 can include a first flat portion 314a and a second or curved portion 314b such that the opening 108 is D-shaped (see FIG. 18B ). As shown, the second portion 314b can generally correspond to and be complementary in shape to the outwardly facing surface 246. For example, the second portion 314b can be an inwardly facing surface (e.g., concavely curved, etc.). When sealing member 302 is disposed around sleeve shaft 220, curved portion 314b contacts outwardly facing surface 246 of open channel 240 and may have the same or substantially the same radius of curvature as outwardly facing surface 246. In this manner, curved portion 314b can seal against and / or around outwardly facing surface 246 when sleeve shaft 220 is disposed within opening 316. In some examples, flat portion 314a can contact and seal against and / or around edge 248 of open channel 240. In this manner, outer sealing portion 306 can create a seal around the outer surface of open channel 240 (e.g., outwardly facing surface 246 and, in some examples, edge 248). In other embodiments, the inner surface 314 can define openings having other shapes that engage with at least the outwardly facing surface 246 of the sleeve shaft 220, including circular openings, square or rectangular openings (e.g., for a U-shaped sleeve shaft 220), etc.

[0120] In some embodiments, sealing member 302 is generally cylindrical. For example, the outer diameter of outer sealing portion 306 can be sized to fit within the chamber of seal housing 252 such that the outer surface of outer sealing portion 306 contacts inner wall 256 of seal housing 252. In some embodiments, as shown, outer sealing portion 306 contacts inner wall 256 in distal segment 252d and contacts proximal surface 264 in proximal segment 252p. In this manner, outer sealing portion 306 can seal a first gap between inner wall 256 of seal housing 252 and outward-facing surface 246 of sleeve shaft 220.

[0121] 16 , the first end 310 of the sealing member 302 may contact the proximal surface 264 of the seal housing 252, and the second end 312 of the sealing member 302 may be positioned toward the distal surface 262 of the seal housing 252. The seal block 304 may contact the distal surface 262. In other embodiments, the hemostatic seal 300 may be oriented differently, such that the first end 310 of the sealing member 302 may contact the distal surface 262, and the second end 312 of the sealing member 302 is positioned toward the proximal surface 264. The seal block 304 may contact the proximal surface 264.

[0122] The sealing member 302 may have a lower durometer than the seal housing 252, the sleeve shaft 220, and the seal block 304. For example, the sealing member 302 may be relatively softer and / or more flexible than the seal housing 252, the sleeve shaft 220, and the seal block 304 such that the seal block 304 can compress at least a portion of the sealing member 302 against the surface of the sleeve shaft 220, and the sealing member 302 can be compressed against the inner surface of the seal housing 252 and around the surface of the sleeve shaft 220 to create a hemostatic seal around the sleeve shaft 220 within the seal housing 252.

[0123] 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, e.g., in a direction perpendicular to the longitudinal axis of the sealing member 302 (and perpendicular to the longitudinal axis 225 of the sleeve shaft 220). The inner protrusion 330 extends axially along the length of the inner sealing portion 308. When the hemostatic seal 300 is coupled to the sleeve shaft 220, the inner protrusion 330 extends axially along the length of the open channel 240. In this manner, the inner protrusion 330 can form a flap or tongue that can be compressed against the inward-facing surface 244 of the open channel 240. Specifically, when the sleeve shaft 220 is disposed within the opening 316 of the sealing member 302, the engagement surface 334 of the inner protrusion 330 can contact the inwardly facing surface 244 of the open channel 240. As shown, the engagement surface 334 can generally correspond to and be complementary to the shape of the inwardly facing surface 244. For example, the engagement surface 334 can have an outwardly facing surface (e.g., a convex curve, 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 inwardly facing surface 244.

[0124] The interior sealing portion 308 may also be configured to seal against the edge 248 of the open channel 240. For example, the interior sealing portion 308 may include flat, axially extending surfaces 322 disposed on either side of the interior protrusion 330 that seal against the edge 248.

[0125] To ensure a sufficient seal between the engagement surface 334 of the inner protrusion 330 and the inward-facing surface 244 of the sleeve shaft 220, a more rigid component can be positioned at least partially within the inner protrusion 330. For example, a relatively rigid component can enhance the structural integrity of the inner protrusion 330 so that the inner protrusion 330 applies a sufficient sealing force to the inward-facing surface 244. In some instances, the inner protrusion 330, or a portion thereof, can 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 can be disposed within an opening or slot in the inner protrusion 330.

[0126] To accommodate a relatively rigid component, the inner protrusion 330 may include a slot 336 extending along a portion of the axial length of the inner protrusion 330. For example, the slot 336 may extend axially from the second end 312 to a second intermediate surface 338 disposed between the first end 310 and the second end 312 of the sealing member 302 ( FIG. 18B ). As shown, the second intermediate surface 338 is axially spaced from the first intermediate surface 318. In other embodiments, the second intermediate surface 338 may be axially aligned with the first intermediate surface 318.

[0127] As described above, in some embodiments, a portion of the seal housing 252 (e.g., the wedge 258) may extend into the slot 336. In some embodiments, both a portion of the seal housing 252 and a portion of the seal block 304 may extend into the slot 336. In other embodiments, as shown in FIGS. 16 and 19-20 , a portion of the seal block 304 may extend into the slot 336 instead of the seal housing 252. When the seal block 304 is coupled to the sealing member 302, this portion of the seal block 304 may extend into the slot 336. For example, the seal block 304 may include a protrusion or wedge 358 configured to extend into the slot 336 to 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.

[0128] As shown in FIGS. 19 and 20 , the seal block 304 may include a first portion 340 at a first end 342 of the seal block 304 that contacts the second intermediate surface 338 of the sealing member 302. The seal block 304 may include a second portion 344 at a second end 346 of the seal 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, e.g., a C-shaped or U-shaped opening, and / or other shapes that the open channel 240 may fit within, such as a circular opening, a square or rectangular opening (e.g., for a U-shaped sleeve shaft 220). In this manner, the second portion 344 of the seal block 304 may surround (e.g., encircle) the outer surface of the sleeve shaft 220.

[0129] In some embodiments, 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 embodiments, as shown in FIG. 20 , the axial length of the first portion 340 of the seal block 304 is equal to the axial length of the slot 336 of the seal member 302 such that the second end 312 of the seal member 302 can contact the intermediate surface 360 ​​of the seal block 304. The intermediate surface 360 ​​can define a transition between the first portion 340 and the second portion 344 of the seal block 304. In the illustrated embodiment, and in embodiments in which the axial length of the first portion 340 is longer than the axial length of the slot 336 of the seal member 302, the inner protrusion 330 (and its engagement surface 334) does not extend into the opening 350. In other embodiments, the axial length of first portion 340 may be less than the axial length of slot 336 such that engagement surface 334 of inner projection 330 extends at least partially into opening 350 .

[0130] The second portion 344 of the seal block 304 may have a cylindrical outer surface. In some embodiments, the outer diameter of the second portion 344 may be smaller than the inner diameter of the inner wall 256 of the seal housing 252 to provide clearance or gap for assembly and / or manufacturing purposes, as shown in FIG. 16 . In other embodiments, the outer surface of the second portion 344 may contact the inner wall 256 of the seal housing 252.

[0131] When sealing member 302 and seal block 304 are coupled together, wedge 358 contacts the inner surface defining slot 336. Specifically, wedge 358 may be configured to hold inner protrusion 330 in place relative to seal housing 252 to ensure a seal between engagement surface 334 of inner protrusion 330 and inward-facing surface 244 of open channel 240. In some embodiments, the shape of slot 336 may correspond to the shape of wedge 358. In other embodiments, slot 336 may be tapered or stepped such that slot 336 is wider nearer the outer surface of sealing member 302 and narrower toward the lower end of slot 336. In these embodiments, wedge 358 may stretch or expand the narrow portion of slot 336 radially outward relative to inward-facing surface 244 of open channel 240.

[0132] The sealing member 302 and the seal block 304 may be coupled together, for example, such that the wedge 358 is positioned within the slot 336, the second end 312 of the sealing member 302 contacts the intermediate surface 360, and / or the seal block 304 contacts the second intermediate surface 338. In some embodiments, the sealing member 302 and the seal block 304 may be coupled together after the sleeve shaft 220 is slidably inserted through the opening 316 of the sealing member 302 and the opening 350 of the seal block 304. For example, after being coupled to the sleeve shaft 220, the sealing member 302 and the seal block 304 may be translated axially until the wedge 356 of the seal 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 seal block 304 contacts the second intermediate surface 338.

[0133] In some instances, the clearance between the seal block 304 and the sleeve shaft 220 may be relatively small, such that it may be difficult to axially overlap the wedge 358 over the relatively soft inner protrusion 330 when the sleeve shaft 220 extends through the openings 316, 350 prior to coupling the sealing member 302 and the seal block 304. In some examples, to facilitate easier coupling of the sealing member 302 and the seal block 304, the sealing member 302 and the seal block 304 may be coupled together in some instances before being coupled to the open channel 240. For example, after the wedge 358 of the seal block 304 axially overlaps the inner protrusion 330 of the sealing member 302, the sleeve shaft 220 may be slidably inserted through the opening 316 of the sealing member 302 and the opening 350 of the seal block 304. When the sleeve shaft 220 is positioned within the openings 316 , 350 , the engagement surface 334 of the inner protrusion 330 may contact the inwardly facing surface 244 .

[0134] As described above, wedge 358 of seal block 304 may function similarly to wedge 258 of upper segment 252 a of seal housing 252 ( FIG. 15 ) to compress a portion of the sealing member against inward-facing surface 244 of open channel 240. Due to the similar functions of wedge 258 of seal housing 252 and wedge 358 of seal block 304, in some embodiments, seal block 304 may be used in place of wedge 258. For example, either wedge may be used to compress an engagement surface of the sealing member (e.g., engagement surface 134, engagement surface 334, etc.) against inward-facing surface 244 of open channel 240. Specifically, although hemostatic seal 100 is described above with reference to wedge 258, hemostatic seal 100 may be used in some embodiments with wedge 358 of seal block 304. For example, seal block 304 may be coupled to second end 124 of inner sealing member 104 such that wedge 358 is positioned within slot 136. As another example, sealing member 302 may be positioned within a chamber defined by upper segment 252a and lower segment 252b such that wedge 258 extends within slot 336. In this example, seal block 304 may be omitted. In some embodiments, both wedge 258 and wedge 358 may be positioned within a slot (e.g., slot 136, slot 336) of a sealing member. For example, wedge 258 of seal housing 252 may be positioned axially between a sealing member (e.g., sealing member 302, inner sealing member 104) and wedge 358 of seal block 304 within the slot of the sealing member.

[0135] In some embodiments, a seal can be created between the engagement surface of the seal's inner protrusion and the inward-facing surface 244 of the sleeve shaft 220 that is sufficient to provide hemostasis without the need for a more rigid component or wedge to be positioned 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 seal's inner protrusion applies a sufficient sealing force to the inward-facing surface 244 during relative axial movement between the sleeve shaft 220 and the seal (e.g., a passive seal).

[0136] 21-22 show one example of a passive hemostatic seal 400 that may be positioned within the seal housing 252. The hemostatic seal 400 includes an outer surface 402 and an inner surface 404 that define an opening 406. The outer surface 402 may contact and / or seal with the inner wall 256 of the seal housing 252 when disposed within the seal housing 252. The open channel 240 of the sleeve shaft 220 may extend through the opening 406.

[0137] The seal 400 may include an internal protrusion 430 configured to seal against the inward-facing surface 244 of the open channel 240. For example, the internal protrusion 430 may 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 sleeve shaft 220). In some embodiments, as shown, the internal protrusion 430 extends axially along the entire length of the seal 400, from the first end to the second end of the seal 400. In other embodiments, the internal protrusion 430 may extend a portion of the entire length of the seal 400. When the hemostatic seal 400 is coupled to the sleeve shaft 220, the internal protrusion 430 extends axially along the length of the open channel 240. Specifically, when sleeve shaft 220 is disposed within opening 406 of seal 400, first engagement portion 434 of inner surface 404 may contact inwardly facing surface 244 of open channel 240. As shown, engagement surface 434 may generally correspond to and be complementary to the shape of inwardly facing surface 244. For example, engagement surface 434 may have an outwardly facing surface (e.g., a convex curvature, etc.). In this manner, inner protrusion 430 may extend or protrude into the opening defined by open channel 240, and first engagement surface 434 may seal against inwardly facing surface 244. In some instances, inner protrusion 430, or a portion thereof, may comprise a different material (e.g., harder, more rigid, etc.) than the remainder of seal 400.

[0138] The shape of the opening 406 may correspond to the cross-sectional shape of the open channel 240, such as a U-shape or a C-shape or an incomplete (e.g., partial) annulus. For example, the inner surface 404 may contact and / or seal against all sides of the open channel 240 (e.g., surfaces 244, 246 and edge 248). For example, the first engaging portion 434 may seal against the inward-facing surface 244, the second engaging portion 410 (e.g., concave, curved portion, etc.) may seal against the outward-facing surface 246, and the third engaging portions 412, disposed on either side of the first engaging portion 434, may seal against the edge 248.

[0139] When seal 400 is disposed within seal housing 252, inner wall 256, distal surface 262, and / or proximal surface 264 can apply a substantially constant force to seal 400 (e.g., rather than a selective compressive locking force applied by locking knob 254) to provide a passive hemostatic seal around open channel 240 of sleeve shaft 220. In this manner, hemostasis can be maintained as sleeve shaft 220 moves relative to seal 400 and seal housing 252.

[0140] As described above, the sleeve shaft 220 can be translated axially relative to other components of the delivery apparatus 200 (e.g., relative to the pusher shaft 212) during various operations of the delivery apparatus 200. For example, during implantation of a docking device (e.g., docking device 52), a user may need to operate the sleeve shaft 220 by moving the sleeve shaft 220 axially relative to other components of the delivery apparatus 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.) apply a relatively high force to the sleeve shaft 220 to hemostatically seal around the open channel 240 of the sleeve shaft 220. This sealing force can increase the force required to move the sleeve shaft 220 axially relative to other components of the delivery apparatus 200.

[0141] To reduce the force required to translate the sleeve shaft 220 relative to other components of the delivery device 200 while maintaining a hemostatic seal around the sleeve shaft 220, a portion of the sleeve shaft 220 may, in some embodiments, include a coating 270 to improve the lubricity of the sleeve shaft 220. FIGS. 23 and 24 illustrate the sleeve shaft 220 in more detail. The lubricious coating 270 may be disposed on the outer surface of the sleeve shaft 220 along the length of the sleeve shaft 220, such as along the portion of the sleeve shaft 220 that extends through a seal (e.g., open channel 240). Specifically, the coating 270 may be located on the open channel 240 of the sleeve shaft 220. In some embodiments, the coating 270 may extend proximally from the transition between the distal segment 250 of the sleeve shaft 220 and the open channel 240 toward the proximal end of the sleeve shaft 220.

[0142] In some embodiments, coating 270 may extend proximally toward sleeve handle 224, but not all the way to the proximal end of sleeve shaft 220. In this manner, the location where sleeve handle 224 is coupled to sleeve shaft 220 (e.g., the proximal end of sleeve shaft 220) does not include lubricious coating 270 to ensure an adequate connection between sleeve handle 224 and sleeve shaft 220. In some embodiments, coating 270 may extend all the way to the proximal end of sleeve shaft 220. In some embodiments, coating 270 may also be disposed on a portion of distal segment 250.

[0143] Coating 270 can be a material that maintains the lubricity of sleeve shaft 220 during operation of delivery device 200, such that lubricity is maintained for multiple axial movements of sleeve shaft 220. In some embodiments, coating 270 can be a hydrophilic material. In some embodiments, coating 270 can be a non-stick material. In some embodiments, coating 270 can be a polytetrafluoroethylene (PTFE) coating or other material that improves the lubricity of sleeve shaft 220.

[0144] FIG. 24 shows a cross-sectional view of the sleeve shaft 220 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 sleeve shaft 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 the radially outward outer surface of the outer surface of the sleeve shaft 220. Thus, when a seal (e.g., any of the seals described herein) is coupled to the open channel 240 of the sleeve shaft 220, the coating 270 is positioned between the sleeve shaft 220 and other components of the delivery device 200, improving the lubricity of the sleeve shaft 220. In some examples, the coating 270 can be considered the outer surface of the sleeve shaft 220.

[0145] In some embodiments, delivery device 200 can include a lubricant to improve the lubricity of sleeve shaft 220. For example, as shown in FIG. 25 , delivery device 200 can include a lubricant chamber 272 positioned adjacent to hemostatic seal 500 that includes a supply of lubricant 274. Lubricant 274 can be PTFE grease, silicone oil, or the like. In the illustrated embodiment, lubricant chamber 272 is positioned within seal housing 252 and axially positioned between the two sealing members of hemostatic seal 500. One or both of the sealing members of hemostatic seal 500 can be any of the hemostatic seals described herein (e.g., seal 100, seal 2400, seal 300, seal 400, etc.). As one example, the sealing member of hemostatic seal 500 positioned distal to lubricant chamber 272 can be configured as seal 400, and the sealing member of hemostatic seal 500 positioned proximal to lubricant chamber 272 can be configured as seal 100. In some embodiments, lubricant 274 may be used in addition to or instead of coating 270 .

[0146] The lubricant chamber 272 may be defined by an inner surface of the seal housing 252. In some embodiments, as shown in FIG. 25 , the lubricant chamber 272 may help maintain the axial position of the seal 500 relative to the seal housing 252. For example, the lubricant chamber 272 may have a diameter smaller than the outer diameter of the seal 500 such that the seal 500 may be positioned against the inner surface of the seal housing 252 that defines the lubricant chamber 272. In this manner, the lubricant chamber 272 may retain a volume of the lubricant 274 and help prevent the seal 500 from moving relative to the seal housing 252 (e.g., during movement of the sleeve shaft 220). In some embodiments, the seal housing 252 may maintain the positioning of the seal 500 relative to the seal housing 252 using other structures (e.g., walls, flanges, lips, etc.) independent of the lubricant chamber 272, for example, as described above. In some embodiments, the lubricant chamber 272 may have a diameter equal to or greater than the outer diameter of the seal 500.

[0147] The open channel 240 of the sleeve shaft 220 is in fluid communication with the lubricant chamber 272. In this manner, as the sleeve shaft 220 moves axially relative to the seal housing 252 (and thus the lubricant chamber 272), the lubricant 274 within the lubricant chamber 272 can coat and improve the lubricity of the open channel 240 of the sleeve shaft 220. In this manner, the lubricant 274 can be applied to the outer surface of the open channel 240.

[0148] Any system, device, apparatus, etc. described herein can be sterilized (e.g., using heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on patients, and any method described herein can include sterilizing the associated system, device, apparatus, etc. as one of its steps. Examples of heat sterilization include steam sterilization and autoclave sterilization. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet light, and electron beams. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. In some examples, the sealing members described herein can be made of silicone, which allows ethylene oxide to diffuse through the material into the medical device. Hydrogen peroxide sterilization can be performed, for example, using hydrogen peroxide plasma.

[0149] Treatment techniques, methods, steps, etc., as described or suggested herein or in the references incorporated herein, may be performed on live animals or may be performed on non-biological simulations such as cadavers, cadaver hearts, anthropomorphic ghosts, simulators (e.g., where a body part, tissue, etc. is simulated), etc.

[0150] delivery technology

[0151] To implant a prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and the distal end 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, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve may be implanted within the native aortic valve via a transapical procedure, whereby the prosthetic valve (on the distal end 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 end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a mini-thoracotomy in the right parasternal region, and then advanced through the ascending aorta toward the native aortic valve.

[0152] To implant a prosthetic valve into the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in radial compression along the distal end portion of a delivery device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve via a transapical procedure, in which the prosthetic valve (on the distal end 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.

[0153] To implant a prosthetic valve into the native tricuspid valve, the prosthetic valve is loaded in radial compression along the distal end portion of a delivery device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a 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.

[0154] Another delivery approach is the transatrial approach, whereby the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, such as through a pulmonary vein. Yet another delivery approach is the transventricular approach, where the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and through an incision made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve within the native tricuspid valve, within the native pulmonary valve, or within the pulmonary artery.

[0155] In all delivery approaches, the delivery device may be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0156] Additional Examples of the Disclosed Technology

[0157] In view of the implementations described above with respect to the disclosed subject matter, the present application discloses the following additional embodiments: It should be noted that any individual feature of an embodiment, or two or more features in any combination of that embodiment, and optionally, any combination of one or more features in one or more additional embodiments, are also additional embodiments falling within the disclosure of the present application. [Example]

[0158] Example 1 a first shaft extending through the seal housing and having an outward-facing surface and an inward-facing surface, the inward-facing surface defining an open channel; a second shaft having a first segment and a second segment, the first segment disposed within the open channel and the second segment extending from the open channel and angled relative to the first segment; and a seal coupled to the first shaft, the seal including a first sealing portion and a second sealing portion, the first sealing portion sealing a first gap between the seal housing and the outward-facing surface of the first shaft and the second sealing portion sealing a second gap between the seal housing and the inward-facing surface of the first shaft, the seal providing constancy when the first shaft moves relative to the seal.

[0159] Example 2. The delivery device of any embodiment herein, particularly embodiment 1, wherein the seal is compressed against the first shaft when the first shaft moves relative to the seal.

[0160] Example 3 The delivery device of any example herein, particularly any of Example 1 or Example 2, wherein the outwardly facing surface of the first shaft is convex and the inwardly facing surface of the first shaft is concave.

[0161] Example 4. The delivery device of any embodiment herein, particularly any one of embodiments 1-3, wherein the second sealing portion comprises an inner protrusion, the inner protrusion comprising a slot and an engagement surface, and the engagement surface of the inner protrusion contacts the inward-facing surface of the first shaft.

[0162] Example 5. The delivery device of any embodiment herein, particularly embodiment 4, wherein a portion of the seal housing extends radially into the slot, and the portion of the seal housing is configured to compress the engagement surface against the inward-facing surface of the first shaft.

[0163] Example 6 The delivery device of any embodiment herein, particularly any of embodiment 4 or embodiment 5, further comprising a seal block coupled to the seal, the seal block including a wedge, the wedge being positioned within the slot.

[0164] Example 7 The delivery device of any example herein, particularly example 6, wherein the durometer of the seal is lower than the durometer of the seal block.

[0165] Example 8 The delivery device of any embodiment herein, particularly any one of embodiments 1-7, further comprising a locking mechanism operably coupled to the first shaft to prevent movement of the first shaft relative to the seal, wherein the seal provides constancy independent of the locking mechanism.

[0166] Example 9. a first shaft extending through the seal housing and having an outward-facing surface and an inward-facing surface, the inward-facing surface defining an open channel; a second shaft having a first segment and a second segment, the first segment disposed within the open channel and the second segment extending from the open channel and angled relative to the first segment; and a seal assembly coupled to the first shaft, the seal including a first sealing member and a second sealing member, the first sealing member sealing a first gap between the seal housing and the outward-facing surface of the first shaft, and the second sealing member sealing a second gap between the seal housing and the inward-facing surface of the first shaft, the seal providing constancy when the first shaft moves relative to the seal.

[0167] Example 10. The delivery device of any embodiment herein, particularly embodiment 9, wherein the seal housing compresses the seal assembly against the first shaft when the first shaft moves relative to the seal.

[0168] Example 11 The delivery device of any example herein, particularly any of example 9 or example 10, wherein the cross section of the first shaft is partially circular.

[0169] Example 12 The delivery device of any embodiment herein, particularly any one of embodiments 9-11, wherein the outwardly facing surface of the first shaft is convex and the inwardly facing surface of the first shaft is concave.

[0170] Example 13 The delivery device of any embodiment herein, particularly any one of embodiments 9-12, wherein the second sealing member comprises an inner protrusion having an engagement surface, the engagement surface contacting an inwardly facing surface of the first shaft.

[0171] Example 14. The delivery device of any embodiment herein, particularly embodiment 13, wherein the second sealing member comprises an opening extending axially from the first end of the second sealing member to the second end of the second sealing member, and the first shaft extends through the opening in the second sealing member.

[0172] Example 15. The delivery device of any embodiment herein, particularly embodiment 14, wherein the inner protrusion extends radially inward into the opening, the inner protrusion being disposed at a second end of the second sealing member.

[0173] Example 16. The delivery device of any embodiment herein, particularly embodiment 15, wherein the second sealing member comprises an intermediate surface axially disposed between the first end and the second end, and an axial end of the inner protrusion defines the intermediate surface.

[0174] Example 17. The delivery device of any embodiment herein, particularly embodiment 16, wherein the second sealing member comprises a slot extending axially along the length of the inner projection.

[0175] Example 18. The delivery device of any embodiment herein, particularly embodiment 17, wherein the slot is an axial through slot extending through the entire length of the inner protrusion, such that a first end of the slot is defined by the intermediate surface and a second end of the slot is defined by the second end of the second sealing member.

[0176] Example 19. The delivery device of any embodiment herein, particularly embodiment 17, wherein the axial length of the slot is less than the overall length of the inner protrusion.

[0177] Example 20. The delivery device of any embodiment herein, particularly any one of embodiments 17-19, wherein the seal housing has an inner wall defining a chamber, and the seal assembly is positioned within the chamber, such that the seal assembly contacts the inner wall.

[0178] Example 21. The delivery device of any embodiment herein, particularly embodiment 20, wherein the inner wall includes a wedge, the wedge protruding radially inward into the slot, and the wedge of the seal housing is configured to compress the engagement surface against the inward-facing surface of the first shaft.

[0179] Example 22. A delivery device described in any embodiment herein, particularly any one of embodiments 17 to 21, further comprising a seal block coupled to the seal assembly, the seal block including a wedge, and the wedge of the seal block positioned within the slot.

[0180] Example 23. The delivery device of any embodiment herein, particularly embodiment 22, wherein the seal assembly has a lower durometer than the seal block.

[0181] Example 24. The delivery device of any embodiment herein, particularly any one of embodiments 9-23, wherein the first sealing member and the second sealing member axially overlap.

[0182] Example 25. The delivery device of any embodiment herein, particularly any one of embodiments 9-23, wherein the first sealing member has an inner surface defining an opening, and the first shaft extends through the opening of the first sealing member.

[0183] Example 26. The delivery device of any embodiment herein, particularly embodiment 25, wherein the opening in the first sealing member is D-shaped.

[0184] 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.

[0185] Example 28. The delivery device of any embodiment herein, particularly embodiment 27, wherein an end of the second sealing member contacts the step.

[0186] Example 29. A delivery device described in any embodiment herein, particularly any one of embodiments 9 to 28, further comprising a handle, the handle comprising a straight segment and a branch segment angled relative to the straight segment, the first shaft extending through the straight segment and the second shaft being at least partially disposed within the branch segment.

[0187] Example 30. The delivery device of any embodiment herein, particularly embodiment 29, wherein the seal housing is connected to the straight segment.

[0188] Example 31. The delivery device of any embodiment herein, particularly any one of embodiments 9 to 29, further comprising a locking mechanism operably coupled to the first shaft to prevent movement of the first shaft relative to the seal, wherein the seal provides constancy independent of the locking mechanism.

[0189] Example 32. 1. A delivery device comprising: a seal housing; a shaft extending through the seal housing, the shaft having an outer surface, the outer surface having an inwardly facing portion and an outwardly facing portion; and a sealing member disposed within the seal housing, the sealing member having an inner surface defining an opening, the shaft extending through the opening of the sealing member, the sealing member including an inner protrusion having an engagement surface that seals against the inwardly facing portion of the outer surface of the shaft, the sealing member providing hemostasis when the shaft is moved relative to the sealing member.

[0190] Example 33. The delivery device of any embodiment herein, particularly embodiment 32, further comprising an outer sealing member coupled to the sealing member, the outer sealing member including an inner surface defining an opening, the shaft extending through the opening of the outer sealing member, the inner surface sealing against an outward-facing portion of the outer surface of the shaft.

[0191] Example 34. The delivery device of any embodiment herein, particularly embodiment 33, wherein the opening in the outer sealing member is D-shaped.

[0192] Example 35. The delivery device of any embodiment herein, particularly any one of embodiments 32-34, wherein the inner protrusion comprises a slot extending axially along the length of the inner protrusion.

[0193] Example 36. The delivery device of any embodiment herein, particularly embodiment 35, having a length less than the total length of the internal projections.

[0194] Example 37. The delivery device of any embodiment herein, particularly embodiment 35, wherein the slot extends the entire length of the inner protrusion.

[0195] Example 38. A delivery device described in any embodiment herein, particularly any one of embodiments 35-37, further comprising a seal block coupled to the sealing member, the seal block including a wedge, the wedge being positioned within the slot.

[0196] Example 39. The delivery device of any embodiment herein, particularly embodiment 38, wherein the sealing block has a higher durometer than the sealing member.

[0197] Example 40. A delivery device according to any embodiment herein, particularly embodiment 38 or embodiment 39, wherein the engagement surface is positioned radially between the inwardly facing portion of the shaft and the wedge.

[0198] Example 41. 1. A seal assembly for a delivery device, the seal assembly comprising: a first sealing member defining a first opening extending axially therethrough, the first opening having an inwardly facing surface configured to seal against an outwardly facing surface of a shaft; and a second sealing member coupled to the first sealing member, the second sealing member defining a second opening extending axially therethrough, the second sealing member having an inner protrusion extending radially into the second opening, the inner protrusion including an outwardly facing engagement surface configured to seal against the inwardly facing surface of the shaft.

[0199] Example 42. The seal assembly of any embodiment herein, particularly embodiment 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.

[0200] Example 43. The seal assembly of any embodiment herein, particularly embodiment 42, wherein the inner protrusion includes a slot extending along an axial length of the inner protrusion, the slot opening radially through the outer surface of the second sealing member.

[0201] Example 44. The seal assembly of any embodiment herein, particularly embodiment 43, wherein the slot defines a third opening extending axially through the second sealing member.

[0202] Example 45. The seal assembly of any embodiment herein, particularly any one of embodiments 41-44, wherein the second sealing member comprises an axial extension at a first end of the second sealing member, the axial extension being disposed about an outer surface of the first sealing member.

[0203] Example 46 The seal assembly of any example herein, particularly example 45, wherein the outer surface of the first sealing member comprises a step.

[0204] Example 47. The seal assembly of any embodiment herein, particularly embodiment 46, wherein the axial extension contacts the step when the first sealing member and the second sealing member are coupled together.

[0205] Example 48. The seal assembly of any embodiment herein, particularly any one of embodiments 40-47, wherein the first opening is D-shaped.

[0206] Example 49. The seal assembly of any embodiment described herein, particularly any one of embodiments 40-48, wherein the second opening is partially annular.

[0207] Example 50. 1. A seal for a delivery device, the seal comprising: a body, the body having a first sealing portion and a second sealing portion, the first sealing portion axially spaced from the second sealing portion, the first sealing portion comprising an opening having an inwardly facing surface, and the second sealing portion comprising an inner protrusion having an outwardly facing surface.

[0208] Example 51. The seal of any embodiment herein, particularly embodiment 50, wherein the opening is D-shaped.

[0209] Example 52. The seal of any embodiment herein, particularly embodiment 50 or 51, wherein the inner protrusion includes a slot extending along an axial length of the inner protrusion, the slot opening radially through an outer surface of the seal.

[0210] Example 53. The seal of any embodiment herein, particularly embodiment 52, wherein the slot opens axially through the end of the seal.

[0211] Example 54. The delivery device of any embodiment herein, particularly any one of embodiments 1 to 40, wherein the delivery device is sterilized.

[0212] Example 55. A delivery device comprising: a sleeve shaft having a first segment and a second segment, the second segment having an inwardly facing outer surface and an outwardly facing outer surface, the second segment comprising a lubricious coating; and a seal coupled to the second segment of the sleeve shaft.

[0213] Example 56. The delivery device of any embodiment herein, particularly embodiment 55, wherein the first segment has a circular cross-section and the second segment has a partially circular cross-section.

[0214] Example 57. The delivery device described in any example herein, particularly example 55 or example 56, wherein the inwardly facing outer surface is concave and the outwardly facing outer surface is convex.

[0215] Example 58. The delivery device of any example herein, particularly any one of Examples 55-57, wherein the lubricious coating comprises a PTFE coating.

[0216] Example 59. The delivery device of any embodiment herein, particularly any one of embodiments 55-58, wherein the sleeve shaft is axially movable relative to the seal.

[0217] Example 60. The delivery device of any embodiment herein, particularly any one of embodiments 55-59, further comprising a seal housing, the sleeve shaft extending through the seal housing, and the seal disposed within the seal housing.

[0218] Example 61. The delivery device of any embodiment herein, particularly embodiment 60, wherein the seal comprises a first sealing portion and a second sealing portion, the first sealing portion sealing a first gap between the seal housing and the outward-facing outer surface of the sleeve shaft, and the second sealing portion sealing a second gap between the seal housing and the inward-facing outer surface of the sleeve shaft, and the seal provides constancy when the sleeve shaft moves relative to the seal.

[0219] Example 62. A delivery device as described in any embodiment herein, particularly embodiment 60, wherein the seal includes an inner surface defining an opening, the sleeve shaft extends through the opening in the seal, the seal includes an inner protrusion having an engagement surface, the engagement surface seals against the inward-facing outer surface of the sleeve shaft, and the seal provides hemostasis when the sleeve shaft moves relative to the seal.

[0220] Example 63. The delivery device of any embodiment herein, particularly embodiment 60, wherein the seal comprises a first sealing member and a second sealing member, the first sealing member sealing a first gap between the seal housing and the outward-facing outer surface of the sleeve shaft, and the second sealing member sealing a second gap between the seal housing and the inward-facing outer surface of the sleeve shaft, and the seal provides constancy when the sleeve shaft moves relative to the seal.

[0221] Example 64. A delivery device described in any embodiment herein, particularly any one of embodiments 55 to 63, further comprising a second shaft that is axially movable relative to the sleeve shaft and extends through a first segment of the sleeve shaft, wherein a portion of the second shaft is angled relative to the sleeve shaft.

[0222] Example 65. 1. A delivery device comprising: a seal housing defining a lubricant chamber containing a lubricant; a seal disposed within the seal housing; and a sleeve shaft extending through the seal housing, the sleeve shaft comprising a first segment and a second segment, the second segment extending through the lubricant chamber and the seal, the second segment comprising an inwardly facing outer surface and an outwardly facing outer surface.

[0223] Example 66. The delivery device of any embodiment herein, particularly embodiment 65, wherein the first segment has a circular cross-section and the second segment has a partially circular cross-section.

[0224] Example 67. The delivery device described in any example herein, particularly example 65 or example 66, wherein the inwardly facing outer surface is concave and the outwardly facing outer surface is convex.

[0225] Example 68. The delivery device of any embodiment herein, particularly any one of embodiments 65-67, wherein the lubricant comprises PTFE grease or silicone oil.

[0226] Example 69. The delivery device of any embodiment herein, particularly any one of embodiments 65-68, wherein the sleeve shaft is axially movable relative to the seal.

[0227] Example 70. A delivery device described in any embodiment herein, particularly any one of embodiments 65-69, wherein the seal includes a first sealing member positioned distal to the lubricant chamber and a second sealing member positioned proximal to the lubricant chamber.

[0228] Example 71. A delivery device described in any embodiment herein, particularly any one of embodiments 65-70, wherein the seal includes a first sealing portion and a second sealing portion, the first sealing portion sealing a first gap between the seal housing and the outward-facing outer surface of the sleeve shaft, and the second sealing portion sealing a second gap between the seal housing and the inward-facing outer surface of the sleeve shaft, and the seal provides constancy when the sleeve shaft moves relative to the seal.

[0229] Example 72. A delivery device described in any embodiment herein, particularly any one of embodiments 65-70, wherein the seal includes an inner surface defining an opening, the sleeve shaft extends through the opening in the seal, the seal includes an inner protrusion having an engagement surface, the engagement surface seals against an inward-facing outer surface of the sleeve shaft, and the seal provides hemostasis when the sleeve shaft moves relative to the seal.

[0230] Example 73. The delivery device of any embodiment herein, particularly embodiment 70, wherein a first sealing member seals a first gap between the seal housing and the outward-facing outer surface of the sleeve shaft, and a second sealing member seals a second gap between the seal housing and the inward-facing outer surface of the sleeve shaft, and the seals provide constancy when the sleeve shaft moves relative to the seal.

[0231] Example 74. A delivery device described in any embodiment herein, particularly any one of embodiments 65 to 73, further comprising a second shaft that is axially movable relative to the sleeve shaft and extends through a first segment of the sleeve shaft, wherein a portion of the second shaft is angled relative to the sleeve shaft.

[0232] Example 75. The delivery device of any example herein, particularly any one of Examples 55-74, wherein the delivery device is sterile.

[0233] Any feature described in this disclosure with respect to any embodiment may be combined with any other feature described in one or more of the other embodiments, unless otherwise specified. For example, any one or more features of one shaft may be combined with any one or more features of another shaft. As another example, any one or more features of one delivery device may be combined with any one or more features of another delivery device.

[0234] In view of the many possible ways in which the principles of this disclosure may be applied, it will be recognized that the illustrated arrangements illustrate examples of the disclosed technology and should not be taken as limiting the scope of the disclosure or the claims. Rather, the scope of claimed subject matter is defined by the following claims, and by equivalents thereof.

Claims

1. 1. A delivery device comprising: A seal housing; a first shaft extending through the seal housing and having an outwardly facing surface and an inwardly facing surface, the inwardly facing surface defining an open channel; a second shaft comprising a first segment and a second segment, the first segment disposed within the open channel and the second segment extending from the open channel and angled relative to the first segment; a seal coupled to the first shaft, the seal including a first sealing portion and a second sealing portion, the first sealing portion sealing a first gap between the seal housing and the outward-facing surface of the first shaft, the second sealing portion sealing a second gap between the seal housing and the inward-facing surface of the first shaft, the seal providing constancy as the first shaft moves relative to the seal.

2. The delivery device of claim 1 , wherein the seal is compressed against the first shaft when the first shaft moves relative to the seal.

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

4. 4. The delivery device of claim 1, wherein the second sealing portion comprises an inner protrusion, the inner protrusion including a slot and an engagement surface, the engagement surface of the inner protrusion contacting the inwardly facing surface of the first shaft.

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

6. The delivery device of claim 4 or claim 5, further comprising a seal block coupled to the seal, the seal block including a wedge, the wedge positioned within the slot.

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

8. 8. The delivery device of claim 1, further comprising a locking mechanism operably coupled to the first shaft to prevent movement of the first shaft relative to the seal, the seal providing constancy independent of the locking mechanism.

9. 1. A delivery device comprising: A seal housing; a shaft extending through the seal housing, the shaft having an outer surface, the outer surface having an inwardly facing portion and an outwardly facing portion; a sealing member disposed within the seal housing, the sealing member including an inner surface defining an opening, the shaft extending through the opening in the sealing member, the sealing member including an inner protrusion having an engagement surface that seals against the inward-facing portion of the outer surface of the shaft, the sealing member providing hemostasis when the shaft is moved relative to the sealing member.

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

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

12. A delivery device according to any one of claims 9 to 11, wherein the inner projection includes a slot extending axially along the length of the inner projection.

13. The delivery device of claim 12 , wherein the length is less than the overall length of the internal projection.

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

15. The delivery device of any one of claims 12 to 14, further comprising a seal block coupled to the sealing member, the seal block including a wedge, the wedge being positioned within the slot.

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

17. 17. A delivery device according to claim 15 or claim 16, wherein the engagement surface is positioned radially between the inwardly facing portion of the shaft and the wedge.

18. 1. A seal assembly for a delivery device, the seal assembly comprising: a first sealing member defining a first opening extending axially therethrough, the first opening having an inwardly facing surface configured to seal against an outwardly facing surface of the shaft; a second sealing member coupled to the first sealing member, the second sealing member defining a second opening extending therethrough in the axial direction, the second sealing member including an inner protrusion extending radially into the second opening, the inner protrusion including an outwardly facing engagement surface configured to seal against an inwardly facing surface of the shaft.

19. 19. The seal assembly of claim 18, 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 the inner projection is disposed at the second end of the second sealing member and defines the intermediate surface.

20. 1. A seal for a delivery device, said seal comprising:

1. A 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, the first sealing portion comprising an opening having an inwardly facing surface, and the second sealing portion comprising an inner protrusion having an outwardly facing surface.

Images