Medical device with a telescopic sealing assembly

Abstract

The present invention discloses a medical device and methods for manufacturing and using the medical device. An example system for delivering an implantable medical device includes a handle member that includes a seal assembly, wherein the seal assembly includes an outer sheath seal assembly coupled to an outer sheath, the outer sheath including a curved portion, and the outer sheath seal assembly being translatable relative to the handle. The seal assembly further includes a first fixed seal assembly fixed relative to the handle, the first fixed seal assembly including a first alignment surface and a compression shaft coupled to the first fixed seal assembly. Additionally, the first alignment surface is designed to align the compression shaft with at least a portion of the outer sheath.

Description

Technical Field

[0001] The present invention relates to medical devices and methods for manufacturing medical devices. More particularly, the present invention relates to medical devices including telescoping seal assemblies designed to prevent fluid leakage within the medical device. Background Art

[0002] A variety of in vivo medical devices have been developed for medical use, such as for intravascular use. Some of these devices include guidewires, catheters, etc. These devices are manufactured by any one of a variety of different manufacturing methods and can be used according to any one of a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is a current need to provide alternative medical devices and alternative methods for manufacturing and using medical devices. Summary of the Invention

[0003] The present invention provides alternative designs, materials, manufacturing methods, and uses for medical devices. An example system for delivering an implantable medical device includes a handle member that includes a seal assembly, where the seal assembly includes an outer sheath seal assembly coupled to an outer sheath, and the outer sheath seal assembly is translatable relative to the handle. The seal assembly further includes a first fixed seal assembly fixed relative to the handle, the first fixed seal assembly including a first alignment surface and a compression shaft coupled to the first fixed seal assembly. Additionally, the first alignment surface is designed to align the compression shaft with at least a portion of the outer sheath.

[0004] Alternatively or additionally for any of the above embodiments, wherein the first fixed seal assembly is positioned proximal to the outer sheath seal assembly.

[0005] Alternatively or additionally for any of the above embodiments, wherein the seal assembly further includes an actuation seal assembly positioned proximal to the first fixed seal assembly, the actuation seal assembly being translatable relative to the handle, and wherein actuation of the actuation seal assembly is designed to displace the implantable medical device between a first position and a second expanded position.

[0006] Alternatively or additionally for any of the above embodiments, wherein the seal assembly further includes a second fixed seal assembly that is fixed relative to the handle and positioned proximal to the actuation seal assembly.

[0007] Alternatively or additionally for any of the above embodiments, wherein the outer sheath includes a curved portion, and wherein the first alignment surface is designed to align the compression shaft with the curved portion of the outer sheath.

[0008] Alternatively or additionally, for any of the above embodiments, the outer sheath includes a protruding portion, the protruding portion is aligned with a bent portion of the outer sheath, and the outer sheath seal assembly includes a recess designed to engage with the protruding portion.

[0009] Alternatively or additionally, for any of the above embodiments, the outer sheath seal assembly includes a first seal, and the first seal is disposed along the outer surface of the outer sheath.

[0010] Alternatively or additionally, for any of the above embodiments, the compression shaft at least partially extends within a cavity of the outer sheath seal assembly.

[0011] Alternatively or additionally, for any of the above embodiments, the outer sheath seal assembly includes a second seal, and the second seal is disposed along the outer surface of the compression shaft.

[0012] Alternatively or additionally, for any of the above embodiments, the system further includes an actuation shaft coupled to the actuation seal assembly, and the actuation shaft at least partially extends within a cavity of the first fixed seal assembly.

[0013] Alternatively or additionally, for any of the above embodiments, the first fixed seal assembly includes a third seal, and the third seal is disposed along the outer surface of the actuation shaft.

[0014] Alternatively or additionally, for any of the above embodiments, the system further includes a guide wire shaft coupled to the second fixed seal assembly, and the guide wire shaft at least partially extends within a cavity of the actuation seal assembly.

[0015] Alternatively or additionally, for any of the above embodiments, the actuation seal assembly includes a fourth seal, and the fourth seal is disposed along the outer surface of the guide wire shaft.

[0016] Another system for delivering an implantable medical device includes:

[0017] A handle member including a telescoping seal assembly, the telescoping seal assembly including:

[0018] An outer sheath seal assembly coupled to an outer sheath that covers at least a portion of the implantable medical device, the outer sheath seal assembly being translatable relative to the handle;

[0019] A first fixed seal assembly including a first alignment surface, the first fixed seal assembly being fixed relative to the handle;

[0020] A compression shaft coupled to the first fixed seal assembly;

[0021] An actuating seal assembly translatable relative to a handle; and

[0022] An actuating shaft coupled to the actuating seal assembly;

[0023] wherein the actuating shaft is axially aligned with a compression shaft;

[0024] wherein a first alignment surface is configured to align the compression shaft with at least a portion of an outer sheath.

[0025] Alternatively or additionally for any of the above embodiments, wherein the actuating seal assembly is configured to displace an implantable medical device between a first position and a second expanded position.

[0026] Alternatively or additionally for any of the above embodiments, wherein the outer sheath includes a curved portion, and wherein the first alignment surface is configured to align the compression shaft with the curved portion of the outer sheath.

[0027] Alternatively or additionally for any of the above embodiments, wherein the outer sheath includes a protruding portion, wherein the protruding portion is aligned with the curved portion of the outer sheath, and wherein the outer sheath seal assembly includes a recess configured to engage the protruding portion.

[0028] Alternatively or additionally for any of the above embodiments, wherein a first fixed seal assembly is positioned proximal to the outer sheath seal assembly, wherein the actuating seal assembly is positioned proximal to the first fixed seal assembly, and wherein a second fixed seal assembly is positioned proximal to the actuating seal assembly.

[0029] Alternatively or additionally for any of the above embodiments, wherein translation of the outer sheath seal assembly is configured to expose at least a portion of the implantable medical device.

[0030] A method of manufacturing a medical device, the method comprising:

[0031] Aligning a first catheter shaft with a handle member, wherein the first catheter shaft includes a curved portion and a protruding portion, wherein the protruding portion is aligned with the curved portion;

[0032] Positioning the protruding portion within a recess of an outer sheath seal assembly translatable to the handle member;

[0033] Aligning a second catheter shaft with the handle member, wherein the second catheter shaft is coupled to a first seal body, and wherein the first seal body includes a first alignment surface;

[0034] Aligning the first alignment surface with a recess in the handle, wherein the recess is configured to mate with the alignment surface; and

[0035] Therein, aligning the second catheter shaft with the handle member aligns the second catheter shaft with the curved portion of the first catheter shaft.

[0036] The foregoing summary of some embodiments is not intended to describe every disclosed embodiment or every implementation of the present invention. The following drawings and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] The present invention may be more fully understood by considering the following detailed description in conjunction with the accompanying drawings, in which:

[0038] Figure 1 is a side view of an exemplary medical device system;

[0039] Figure 2 is a partial cross-sectional view of a portion of an exemplary medical device delivery system;

[0040] Figure 3 is a partial cross-sectional view of a portion of an exemplary medical device delivery system;

[0041] Figure 4 is a partial cross-sectional view of a portion of an exemplary medical device delivery system;

[0042] Figure 5 is a partial cross-sectional view of a portion of an exemplary medical device delivery system;

[0043] Figure 5A is a side view of an exemplary coupling assembly;

[0044] Figure 5B is a side view of another exemplary coupling assembly;

[0045] Figure 5C is along Figure 5 a partial cross-sectional view of a portion of an exemplary medical device delivery system taken along line 5C-5C;

[0046] Figure 5D is a partial cross-sectional view of a portion of an exemplary medical device delivery system;

[0047] Figure 6 is a partial cross-sectional view of a portion of an exemplary medical device delivery system;

[0048] Figure 6A is along Figure 6 a partial cross-sectional view of a portion of an exemplary medical device delivery system taken along line 6A-6A;

[0049] Figure 7 is a partial cross-sectional view of a portion of an exemplary medical device delivery system;

[0050] Figure 8 is a cross-sectional view of a portion of an exemplary medical device delivery system along line 8-8; Figure 7

[0051] Figure 9 is another exemplary cross-sectional view of a portion of an exemplary medical device delivery system along line 8-8; Figure 7

[0052] Figure 10 is a partial cross-sectional view of a portion of an exemplary medical device delivery system;

[0053] Figure 11 is a partial cross-sectional view of a portion of an exemplary medical device delivery system.

[0054] While the present invention is susceptible to various modifications and alternative forms, specific details thereof have been shown by way of example in the drawings and will be described in more detail. It is to be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. DETAILED DESCRIPTION

[0055] For the terms defined below, unless a different definition is given in the claims of this specification or elsewhere, these definitions shall apply.

[0056] All numerical values are herein assumed to be modified by the term "about", whether or not explicitly indicated. The term "about" generally refers to a numerical range that a person skilled in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" may include numbers that round to the nearest significant digit.

[0057] The recitation of a numerical range by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0058] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0059] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc., indicate that the described embodiments may include one or more specific features, structures, or characteristics. However, such recitation does not necessarily mean that all embodiments include that specific feature, structure, and / or characteristic. Additionally, when a specific feature, structure, and / or characteristic is described in connection with an embodiment, it is understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless stated to the contrary.

[0060] The following detailed description should be read with reference to the accompanying drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0061] Diseases and / or medical conditions affecting the cardiovascular system are prevalent throughout the world. Traditionally, treatment of the cardiovascular system has generally been performed by directly accessing the affected part of the body. For example, coronary artery bypass surgery has traditionally been used to treat blockages in one or more of the coronary arteries. As can be readily appreciated, such therapies are quite invasive to the patient and require significant recovery time and / or treatment. More recently, less invasive therapies have been developed. For example, therapies have been developed that allow access to and treatment of blocked coronary arteries via a percutaneous catheter (e.g., angioplasty). Such therapies have gained wide acceptance among patients and clinicians.

[0062] Some relatively common medical conditions may include the inefficiency, ineffectiveness, or complete failure of one or more of the heart valves, or the consequences thereof. For example, the failure of the aortic valve or the mitral valve can have a severe impact on a person and, if not properly addressed, can lead to serious health conditions and / or death. Treating defective heart valves presents additional challenges because treatment typically requires repairing or completely replacing the defective valve. Such therapies are highly invasive to the patient. Medical devices are disclosed herein that can be used to deliver a medical device to a portion of the cardiovascular system to diagnose, treat, and / or repair the system. At least some of the medical devices disclosed herein can be used to deliver and implant replacement heart valves (e.g., replacement aortic valve, replacement mitral valve, etc.). Additionally, the devices disclosed herein can deliver replacement heart valves percutaneously and are thus much less invasive to the patient. The devices disclosed herein can also provide a number of additional desired features and benefits, as described in more detail below.

[0063] The drawings illustrate, for example, in Figure 1Selected components and / or arrangements of the medical device system 10 schematically shown therein. It should be noted that in any given drawing, for simplicity, some features of the medical device system 10 may not be shown or may be shown schematically. Additional details regarding some of the components of the medical device system 10 may be shown in more detail in other drawings. The medical device system 10 can be used to deliver and / or deploy various medical devices to multiple locations within an anatomical structure. In at least some embodiments, the medical device system 10 can include a replacement heart valve delivery system (e.g., a replacement aortic valve delivery system) that can be used to percutaneously deliver a medical implant 16 ( Figure 1 as shown in the detailed view therein), such as a replacement / prosthetic heart valve. However, this is not intended to be limiting, as the medical device system 10 can also be used to perform other interventions, including valve repair, valvuloplasty, delivery of implantable medical devices (e.g., stents, grafts, etc.), and other similar interventions.

[0064] The medical device system 10 can generally be described as a catheter system that includes an outer sheath 12; an inner catheter 14 that at least partially extends through the lumen of the outer sheath 12; and a medical implant 16 (e.g., a replacement heart valve implant) that can be coupled to the inner catheter 14 during delivery of the medical implant 16 and disposed within the lumen of the outer sheath 12. In some embodiments, a handle 17 of the medical device can be provided at the proximal end of the outer sheath 12 and / or the inner catheter 14 and can include one or more actuation mechanisms associated therewith. In other words, one or more tubular members (e.g., the outer sheath 12, the inner catheter 14, etc.) can extend distally from the handle 17 of the medical device. Generally, the handle 17 of the medical device can be configured to manipulate the position of the outer sheath 12 relative to the inner catheter 14 and / or assist in deploying the medical implant 16.

[0065] It can be understood that the medical device system 10 can be designed such that the handle 17 can manually and / or electrically actuate one or more components of the medical device system 10 (via one or more motors located inside and / or outside the handle 17). In other words, it is contemplated that in some cases, a clinician can manually manipulate the handle (e.g., via linear or rotational actuation) to deploy the medical implant 16. However, it is also contemplated that in other examples, a clinician can engage one or more selection switches (e.g., buttons) that can activate one or more electric motors to actuate and deploy the medical implant 16.

[0066] Additionally, in some examples, the outer sheath 12 of the medical device system 12 can include a curved portion 13. Although Figure 1Shows a curve of the outer member 12 within the plane of the page, but other configurations are also conceivable. For example, a configuration can be envisioned in which the curve of the outer member extends outside the page.

[0067] In use, the medical device system 10 can be advanced transcutaneously through the vasculature to a position adjacent to the region of interest and / or treatment location. For example, in some embodiments, the medical device system 10 can be advanced through the vasculature to a position adjacent to a defective native valve (e.g., aortic valve, mitral valve, etc.). The medical device system 10 can also contemplate alternative ways of treating defective aortic valves and / or other heart valves. During delivery, the medical implant 16 can typically be disposed in the lumen and / or distal end of the outer sheath 12 in an elongated and low-profile "delivery" configuration, as schematically seen, for example, Figure 1 Once positioned, the outer sheath 12 can be retracted relative to the medical implant 16 and / or the inner catheter 14 to expose the medical implant 16. In some cases, the medical implant 16 can be self-expanding such that the exposure of the medical implant 16 can deploy the medical implant 16. Alternatively, the handle 17 of the medical device can be used to expand / deploy the medical implant 16 in order to translate the medical implant 16 into a generally shortened and larger-profile "deployment" configuration suitable for implantation within the anatomy. When the medical implant 16 is properly deployed within the anatomy, the medical device system 10 can be disconnected, detached, and / or released from the medical implant 16, and the medical device system 10 can be removed from the vasculature, leaving the medical implant 16 in place in a "released" configuration.

[0068] It can be appreciated that during the delivery and / or deployment of an implantable medical device (e.g., the medical implant 16), it may be necessary to advance portions of the medical device system (e.g., the medical device system 10) through tortuous and / or stenotic body cavities. Thus, it may be necessary to utilize components that reduce the profile of portions of the medical device while maintaining sufficient strength (compression, torsion, etc.) and flexibility of the overall system and to design such a medical delivery system (e.g., such as the medical device system 10 and / or other medical devices).

[0069] Figure 2 Shows the medical device system 10 in a partially deployed configuration. As Figure 2 shown, the outer sheath 12 of the medical device system 10 has been retracted in the proximal direction to a position proximal to the medical implant 16. In other words, the outer sheath 12 has been retracted in the proximal direction (e.g., pulled back) such that the outer sheath 12 has exposed the medical device implant 16 from a compact low-profile delivery position to a partially deployed position.

[0070] In at least some examples contemplated herein, the medical device implant 16 can be designed to self-expand once released from beneath the outer sheath 12. However, as Figure 2 shown, the medical device system 10 can be designed such that the implant 16 can be restricted from fully expanding in the radial direction. For example, Figure 2 shows a medical device implant 16 having a partially deployed position represented as length “L1”.

[0071] Figure 2 Also shown is that, in some examples, the implant 16 can include one or more support members 22 coupled to the proximal end 18 of the implant 16. Additionally, Figure 2 shown is that, in some examples, the implant 16 can include one or more translation members 24 coupled to the distal end 20 of the implant 16. Additionally, in some examples (such as those shown in Figure 2 ), the translation member 24 and the support member 22 can work together to hold the implant in a partially deployed position after the outer sheath 12 has been retracted to expose the implant 16. For example, Figure 2 shown is that the support member 22 can be designed such that the distal end of each of the support members 22 can be coupled to the proximal end of the implant 16 and the proximal end of each of the support members 22 can be coupled to the distal end of the inner catheter 14. For example, Figure 2 shown is that the proximal end of the support member 22 can be attached to the receiving fitting 29, which is rigidly fixed to the distal end of the inner catheter 14. It can also be understood that, in some cases, the support member 22 can be designed to restrict proximal movement of the proximal end 18 of the implant 16 relative to the distal end of the inner catheter 14.

[0072] Additionally, the translation member 24 can be designed to translate in a distal-to-proximal direction such that translation of the translation member (e.g., via operation by an operator on a handle) can “pull” the distal end 20 of the implant closer to the proximal end 18 of the implant 16.

[0073] For example, Figure 3 shown is the translation of the translation member 24 from distal to proximal. It can be understood that if the support member 22 restricts proximal movement of the proximal end 18 of the implant 16 while the translation member 24 translates proximally, the implant 16 can shorten (along the longitudinal axis of the implant 16) and can also expand radially outward. By comparing the Figure 2 shape and position of the implant 16 in Figure 3 with the shape and position of the implant 16 in Figure 3 the shortening and radial expansion of the implant 16 can be seen. Figure 2compared to the position of the partial deployment of the implant 16 shown in). Further, Figure 3 depicts the length of the fully deployed implant 16 as "L2", while the distance L2 is less than Figure 2 the distance L1 shown in.

[0074] Additionally, it can be understood that the translation member 24 can be designed to be capable of extending in a proximal-to-distal direction such that it elongates (e.g., extends) the implant 16 (along its longitudinal axis). In other words, since the support member 22 restricts the movement of the proximal end 18 of the implant 16, the implant 16 can be translated (proximally or distally) along the longitudinal axis by the translation member 24 between the partially deployed position ( Figure 2 shown in) and the fully deployed position ( Figure 3 shown in).

[0075] It should be noted that the above description and illustration of the arrangement, attachment features, and operation of the support member 22 and the translation member 24 when they are engaged and operate relative to the implant 16 are schematic. It can be understood that the design (e.g., arrangement, attachment features, operation, etc.) of the support member 22 and the translation member 24 when they are associated and operate relative to the implant 16 can vary. For example, the translation member 24 and the support member 22 can be designed, arranged, and operated in various ways to achieve the partially and fully deployed configurations of the implant 16 described herein.

[0076] In some examples, the operator may be able to manipulate the translation member 24 via the handle 17. For example, the handle 17 can include an actuating member designed to control the translation of the translation member 24. Figure 2 It is shown that the handle member 17 can be coupled to the translation member 24 via the actuating shaft 30 and the coupling member 28. Additionally, Figure 2 it is also shown that the distal end of the actuating shaft 30 can be coupled to the proximal end of the coupling member 28. Further, although not shown in Figure 2 it can be understood that the actuating shaft 30 can extend from the coupling member 28 to the handle member 17 throughout the length of the inner catheter 14.

[0077] For the purposes of the discussion herein, the inner catheter 14 can also be referred to as the inner member or liner 14. The liner 14 can include many different features shown in the drawings described herein. For example, the liner 14 can include a lumen 25. Additionally, the translation member 24, the coupler 28, the actuating shaft 30, the tubular guidewire member 34 (described below), and the grouped coils 32 (described below) can be disposed within the lumen 25. These are merely examples. The form of the inner liner 14 can vary. For example, the inner liner 14 can include a single lumen, multiple lumens, or no lumen.

[0078] As described above, Figure 2and Figure 3 shows the translation of the translation member 24 in the distal-to-proximal direction (which, as described above, shortens and radially expands the implant 16). However, Figure 3 also shows that the translation of the translation member 24 in the distal-to-proximal direction is achieved by the translation of the actuation shaft 30 and the coupling member 28 within the lumen 25 of the inner catheter 14. For example, when the actuation shaft 30 is retracted (e.g., pulled proximally within the lumen 25 of the inner catheter 14), the actuation shaft 30 retracts the coupling member 28 proximally, which in turn retracts the translation member 24 in the proximal direction.

[0079] In some cases, when the translation member 24 is translated within the lumen 25 of the inner catheter 14, it may be desirable to maintain the translation member 24 in a substantially linear configuration. Thus, in some examples, the medical device system 10 may include components designed to limit and / or prevent the translation member 24 from twisting about each other within the lumen 25 of the inner catheter 14. For example, Figure 2 and Figure 3 shows the grouped coils 32 wound around the translation member 24 such that as the translation member 24 is translated through the lumen 25 of the inner catheter 14, the grouped coils 32 maintain the translation member 24 in a substantially linear configuration (and thereby limit and / or prevent the translation member 24 from twisting within the lumen 25).

[0080] Figure 2 and Figure 3 also shows that the proximal end of the grouped coils 32 may be positioned adjacent to the distal end of the coupling member 28, and the distal end of the grouped coils 32 may be positioned adjacent to the distal end of the inner catheter 14. In particular, the distal end of the grouped coils 32 may be prevented from extending distally beyond the distal end of the inner catheter 14 by a containment fitting 29. In other words, the distal end of the grouped coils 32 may contact the containment fitting 29.

[0081] It can be further understood that the grouped coils 32 may be positioned within the lumen 25 of the inner catheter 14 such that the grouped coils 32 may elongate and shorten within the lumen 25 of the inner catheter 14 (e.g., the length of the grouped coils may be adjusted). For example, when the coupling member 28 is translated in the proximal direction (compared to Figure 2 as shown in Figure 3 ), the grouped coils 32 may elongate while continuing to group and / or contain the translation member 24 in a substantially linear configuration.

[0082] Figure 2 and Figure 3Also shown is that the medical device system 10 can include a tubular guidewire member 34 extending within the lumen 25 of the inner catheter 14. The tubular guidewire member 34 can include a lumen that allows a wire to extend and translate therethrough. In other words, the medical device system 10 can be advanced over a wire extending within the lumen of the tubular guidewire member 34 to a target site within the body. Additionally, the tubular guidewire member 34 can extend from the handle member 17, through the lumen 25 of the inner member 14, through the implant 16 and terminate at the nose cone 36.

[0083] In some cases, it may be beneficial to maintain a constant distance between the distal end 20 of the implant 16 and the proximal end 21 of the nose cone 36, as restricting the distance that the nose cone 36 extends into the ventricle during implantation of the implant 16 can reduce the likelihood that the nose cone 36 will perforate surrounding tissue. In other words, retracting the nose cone 36 proximally can pull the nose cone away from the surrounding tissue to reduce the likelihood that the nose cone 36 will puncture surrounding tissue.

[0084] Thus, as will be described in more detail below, Figure 2 and Figure 3 shown is that the medical device system 10 can be designed such that when the implant 16 is transitioning between a partially deployed position ( Figure 2 as shown) and a fully deployed position ( Figure 3 as shown), the distance between the distal end 20 of the implant 16 and the proximal end 21 of the nose cone 36 can remain constant. In other words, when the implant 16 is transitioning between a partially deployed position and a fully deployed position, the actuation shaft 30 and the guidewire member 34 can retract together (as they can be coupled together, which will be described in more detail below), thereby maintaining a constant spacing ("Z") between the distal end 20 of the implant 16 and the proximal end 21 of the nose cone 36.

[0085] As shown in Figure 2 and Figure 3 in some cases, the inner catheter 14 can include an outer skeleton 40 disposed along the outer surface of the inner catheter 14. The outer skeleton 40 can be positioned between the outer member 12 and the inner catheter 14. For example, the outer skeleton 40 can be positioned between the inner surface of the outer member 12 and the outer surface of the inner catheter 14. Additionally, the distal end 42 of the outer skeleton 40 can be rigidly fixed relative to the end region of the inner member 14. In some examples, the distal end 42 of the outer skeleton 40 can be directly fixed to the inner member 14. In other examples, the outer skeleton 40 can be attached to a fitting (not shown) that is directly fixed to the inner member 14. In other cases, a restraint fitting 29 (or other similar fitting) can be used to prevent the distal end 42 of the outer skeleton 40 from moving relative to the end region 26 of the inner member 14.

[0086] The outer skeleton 40 can include a plurality of discrete components or articulated links. For example, the outer skeleton 40 can include a plurality of bead-shaped components 41 and a plurality of barrel-shaped components 43. Other discrete components can be envisioned, which can have different shapes and / or configurations. Generally, the discrete components (e.g., bead-shaped components 41 and barrel-shaped components 43) engage with each other and are designed to increase the compressive strength, tensile strength, or both of the inner conduit 14, while also providing a desired amount of flexibility and kink resistance, such that the inner conduit 14 can be navigated through anatomical structures. The bead-shaped components 41 and the barrel-shaped components 43 can be arranged along the inner conduit in a plurality of different configurations. In at least some cases, the bead-shaped components 41 and the barrel-shaped components 43 alternate along the inner conduit 14. Other arrangements and / or patterns can also be envisioned.

[0087] From the above discussion, it can be understood that the outer member 12, the inner shaft 14 (including the outer skeleton 40), the actuation shaft 30 (coupled to the translation member 24), and the tubular guidewire member 34 can all extend from a position adjacent to the medical implant 16 to their position of entry into the handle member 17. For example, Figure 4 It is shown that the outer sheath 12, the inner shaft 14 (including the outer skeleton 40), the actuation shaft 30 (which is coupled to the translation member 24), and the tubular guidewire member 34 can extend from an exemplary medical implant 16 (which can be similar in form and function to the above-described medical implant) and enter the distal end 45 of the handle member 17.

[0088] In some cases, it may be desirable to design the medical device system 10 such that the inner member 14 has an orientation relative to the outer member 12 that is different from Figure 2 and Figure 3 that shown in the illustration. For example, Figure 4 The distal end of the medical device system 10 extending out of the page in a hooked configuration is shown. Additionally, Figure 4 It is shown that the inner member 14 can be rotated 90 degrees compared to the inner member 14 shown in Figure 2 and Figure 3 . Thus, rotation of the inner member 14 can also rotate both the actuation shaft 30 and the tubular guidewire member 34 (positioned within the lumen 25 of the inner member 14) such that they are side-by-side (e.g., in a horizontal plane) when exiting the distal end of the handle 17. When viewed from the end of the handle, in some examples, the actuation shaft 30 can be on the left, while the tubular guidewire member can be on the right 34 (further shown in Figure 5A ). In other examples, the actuation shaft 30 can be on the right, while the tubular guidewire member 34 can be on the left. In the example shown in Figure 4 , the actuation shaft 30 is on the right when exiting the distal end of the handle 17, while the tubular guidewire member 34 is on the left. Thus, Figure 4The detailed view of FIG. 1 shows the tubular guidewire member 34 positioned within the liner 14, whereby the actuation shaft 30 can be conceptualized as being positioned "behind" the tubular guidewire member. However, it can be appreciated that when the distal end of the medical device 10 is bent around and pointed in the proximal direction, the actuation shaft 30 can remain on the outer radius and thus be positioned at the distal end of the liner 14. Figure 4 34 is visible in the non-detailed view of (while the tubular guidewire member 34 becomes hidden behind the actuation shaft 30).

[0089] Figure 4 It is also shown that in some examples, the exoskeleton 40 (described above) can be attached to a compression hypotube 44, a portion of which can be disposed along the inner member 14. In some examples, a portion of the compression hypotube 44 can be positioned above the inner member 14. The hypotube 44 can be aligned with the alternating bead 41 and barrel 43 components of the exoskeleton 40. For example, in some cases, the alternating bead 41 and barrel 43 components of the exoskeleton 40 can abut the hypotube 44 at a location within the handle member 17. For example, Figure 4 The detailed view of shows that the distal end 46 of the compression hypotube 44 can be positioned adjacent to the bead or barrel assembly 41 / 43. In other words, the distal end 46 of the compression hypotube 44 can directly engage (e.g., contact) the bead or barrel assembly 41 / 43 of the exoskeleton 40. In addition, in some examples, the compression hypotube 44 can be rigidly attached (e.g., welded) to the exoskeleton 40. As will be discussed in more detail below, the compression hypotube 44 can extend into the handle member 17 and terminate within the handle member 17.

[0090] Additionally, in some examples, the compression hypotube 44 can be welded to the exoskeleton 40 such that the exoskeleton 30 is placed under a compressive load. In other words, the medical device 10 can be manufactured such that the bead and barrel assemblies 41 / 43 can be compressed against each other to a given load, whereupon the distal end of the compression hypotube 44 is subsequently welded to the proximal end of the exoskeleton 40, thereby placing the bead and barrel assemblies 41 / 43 of the exoskeleton 40 under a fixed compressive load.

[0091] As will be discussed in more detail below, the proximal end of the compression hypotube 40 can terminate within the exoskeleton seal assembly 54. The exoskeleton seal assembly can be fixed relative to the handle 17, and therefore, it can be appreciated that the exoskeleton 40 can be held under a compressive load like other seal assemblies (e.g., outer sheath seal assembly 52, actuation seal assembly 56, etc.), and actuate other assemblies (e.g., outer member 12, actuation shaft 30) to deploy the implant 16.

[0092] It will be appreciated that actuation of the various components described above (e.g., outer member 12, inner shaft 14, actuation shaft 30, and tubular guidewire member 34) can be carried out via various actuation mechanisms disposed within handle member 17. It will also be appreciated that the actuation mechanisms can operate to move the various tubular components relative to one another. Additionally, each individual actuation mechanism may need to be fluid-sealed to prevent fluid leakage into portions thereof, including components residing therein, which may be damaged or contaminated upon contact with the fluid.

[0093] Figure 4 An example telescoping fluid seal assembly 50 is shown. The fluid seal assembly 50 can include an outer sheath seal assembly 52, an outer skeleton seal assembly 54, an actuation member seal assembly 56, and a guidewire member seal assembly 58, each of which will be described in more detail below. The outer sheath seal assembly 52 can include a luer lock fill port 53. The luer lock fill port 53 can include a check valve 91. It will be appreciated that each of the outer member 12, inner shaft 14 (including portions of the outer skeleton 40), actuation shaft 30, and tubular guidewire member 34 can be coupled to one or more of the outer sheath seal assembly 52, outer skeleton seal assembly 54, actuation member seal assembly 56, and guidewire member seal assembly 58.

[0094] In some examples, one or more of the outer sheath seal assembly 52, outer skeleton seal assembly 54, actuation member seal assembly 56, and / or guidewire member seal assembly 58 can be fixed relative to the handle 17. However, in other examples, one or more of the outer sheath seal assembly 52, outer skeleton seal assembly 54, actuation member seal assembly 56, and / or guidewire member seal assembly 58 can be translated relative to the handle 17. For example, in some examples, the outer sheath seal assembly 52 and the actuation member seal assembly 56 can be translated relative to the handle 17, while the outer skeleton seal assembly 54 and the guidewire member seal assembly 58 can remain fixed relative to the handle 17.

[0095] Figure 5 An example outer sheath seal assembly 52 is shown. As described above, the outer sheath seal assembly 52 can include a luer lock fill port 53. The luer lock fill port can include a one-way check valve 91. Additionally, the outer sheath seal assembly 52 can include a body 59. Additionally, the body 59 can include a post 48 extending in a direction parallel to the longitudinal axis of the handle member 17. The post 48 can include a chamber 63 into which the proximal end of the outer member 12 can be inserted. Additionally, the post 48 of the body 59 can include a threaded region 60.

[0096] The outer sheath seal assembly 52 can be designed to seal the outer member 12 while providing a passage (e.g., a lumen) for the compression hypotube 44, the actuation shaft 30, and the tubular guidewire member 34 to extend therein (as discussed above, the tubular guidewire member 34 is disposed within the outer sheath seal assembly 52). Figure 5 This is not visible because it is hidden behind the actuation shaft 30). For example, Figure 5 The outer sheath seal assembly 52 is shown to include an outer seal 51. The outer seal 51 may be an O-ring or other similar type of seal. Figure 5 As shown in , the outer seal 51 can be positioned between the inner surface of the post 48 of the body 59 and the outer surface of the outer member 12.

[0097] Additionally, the outer jacket seal assembly 52 can include a sealing nut 47. The sealing nut 47 can include a threaded region 61. It will be appreciated that the sealing nut 47 can be designed to mate with the post 48. For example, it will be appreciated that the sealing nut 47 can be designed to be screwed to (e.g., screwed to) the post 48 of the body 59.

[0098] Figure 5 It is also shown that in some examples, the outer member 12 can include a collar 49??, which can be attached to the outer surface of the outer member 12. In some examples, the collar 49 can be overmolded onto the outer surface of the outer member 12. Figure 5 , the outer surface of the collar 49 can be contoured to mate with a portion of the inner surface of the sealing nut 47. It can also be appreciated that the sealing nut 47, the collar 49, the post 48, and the outer seal 51 can cooperate to prevent fluid from leaking out of the outer sheath seal assembly 52. ​​Specifically, the rotation of the sealing nut 47 onto the post 48 can translate the collar 49 in the distal to proximal direction, thereby compressing the outer seal 51 onto the outer surface of the outer member 12.

[0099] Figure 5 It is also shown that the sealing assembly 52 can include a threaded support ring 57. The support ring 57 can be threadedly engaged with the mating threaded portion 62 of the body member 59. The threaded support ring 57 can be designed to compress the hypotube seal 55 onto the compression hypotube 44. For example, rotation of the support ring 57 onto the body 59 can compress the hypotube seal 55 onto the outer surface of the hypotube 44. In at least some examples, the hypotube seal 55 can be an X-ring type seal, however, other seal configurations can also be envisioned. In the case where the compression hypotube 44 is translated through the hypotube seal 55, using an X-ring seal design for the hypotube seal 55 can reduce friction on the compression hypotube 44.

[0100] from Figure 5As can be appreciated from the illustrations in and the above discussion, the outer member 12 can terminate within the outer sheath seal assembly 52. ​​Therefore, it can be further appreciated that actuation of the outer sheath seal assembly 52 can actuate (e.g., shift, translate, move, etc.) the outer sheath 12. Although not explicitly shown in the drawings, it can be appreciated that the handle 17 can include one or more actuation mechanisms that are designed to actuate the outer seal assembly 52, which can cause the outer member 12 to shift relative to the hypotube 44, the actuation shaft 30, and the tubular guidewire member 34. Actuation of the outer member 12 can expose (e.g., partially deploy) the medical device 16 described above. Additionally, the outer member 12 can be actuated to actuate the outer sheath seal assembly 52. Figure 5 It is understood that the sealing assembly 52 can translate along the compression hypotube 44 (eg, slide along the outer surface thereof).

[0101] As discussed above, Figure 5 It is also shown that the actuation shaft 30 and the tubular guidewire member 34 can be engaged and coupled together via a coupling assembly 77. The coupling assembly 77 can be designed to couple the actuation shaft 30, the tubular guidewire member 34, and an actuation hypotube (e.g., a cannula) 78 together while allowing the tubular guidewire member 34 to extend through at least a portion of the actuation hypotube 78.

[0102] Figure 5A An example coupling assembly 177 is shown. Coupling assembly 177 shows an example embodiment of the coupling assembly 77 described above. Coupling assembly 177 may include a distal region 186, a proximal region 187, and an intermediate (e.g., body) region 188. As will be described below, coupling assembly 177 may have a cavity extending therein. It will be appreciated that when coupling assembly 177 is aligned within medical device 10, distal region 186 of coupling assembly 177 may be positioned closer to medical implant 16 (e.g., Figure 1 ), while the proximal region 187 can be positioned closer to the proximal handle 17 (e.g., Figure 1 ).

[0103] Figure 5A The distal region 186 of the coupling assembly 177 is also shown to include one or more channels 189 extending along the distal region 186. As discussed in more detail below, it will be appreciated that the channels 189 can be sized to receive an elongated member (e.g., a catheter shaft, a tubular member, etc.). One or more of the channels 189 can extend partially or completely along the length of the distal region 186.

[0104] Figure 5AAlso shown is that the coupling assembly 177 can include a hole 190 positioned along the proximal region 187. The hole 190 can extend partially or completely through the wall thickness defining the proximal region 187. Additionally, the hole 190 can be generally oval-shaped. However, this is not intended to be limiting. Rather, the hole 190 can include a variety of shapes. For example, the hole 190 can be circular, rectangular, triangular, etc. In some examples, the actuation shaft 30 can be coupled (e.g., fixed, attached, disposed along, etc.) to the distal region 186 of the coupling assembly 177.

[0105] In addition, each of the actuation shaft 30 and the tubular guidewire member 34 can be disposed along one of the channels 189 located in the distal region 186 of the coupling assembly 177. Additionally, in some examples, a portion of the actuation shaft 30 disposed along the distal region 186 of the coupling assembly 177 can be welded to the distal region 186 of the coupling assembly 177. Additionally, the proximal portion of the actuation hypotube 78 can engage with the proximal region 187 of the coupling assembly 177. It can be understood that the lumen of the actuation hypotube 78 can extend above the top of the proximal region 187 of the coupling assembly 177. It can also be understood that the inner diameter of the lumen of the actuation hypotube 78 can be sized to provide a tight fit above the tops of the coupling assembly 177 and the tubular guidewire member 34.

[0106] Figure 5B Another example coupling assembly 277 is shown. The coupling assembly 277 shows another example embodiment of the above-described coupling assembly 77. The coupling assembly 277 can be similar in form and function to the above-described coupling assembly 177. For example, the coupling assembly 277 can include a distal region 286 (including a channel 289), an intermediate region 288, and a proximal region 287. However, as Figure 5B shown, the proximal region 287 of the coupling assembly 277 can include a chuck 293. The chuck 293 can include one or more fingers 294a, 294b, and 294c (a fourth chuck finger 294d can be included, but the fourth chuck finger 294d can also be Figure 5B hidden by the chuck fingers 294a - 294c as shown). It can be understood that the chuck fingers 294a - 294d can be circumferentially spaced apart about the longitudinal axis of the coupling assembly 277.

[0107] Similar to that described above with respect to the chuck assembly 177, each of the actuation shaft 30 and the tubular guidewire member 34 can be disposed along one of the channels 289 located in the distal region 286 of the coupling assembly 277. Additionally, in some examples, a portion of the actuation shaft 30 disposed along the distal region 286 of the coupling assembly 277 can be welded to the distal region 286 of the coupling assembly 277.

[0108] Additionally, the proximal portion of the actuating hypotube 78 can engage the chuck 293 of the coupling assembly 277. Specifically, it can be understood that the lumen of the actuating hypotube 78 can extend over the respective fingers 294a - 294d of the chuck 293. It can be understood that the inner diameter of the actuating hypotube 78 can be sized such that it contacts the respective fingers 294a - 294d of the chuck 293 and presses them down onto the outer surface of the tubular guidewire member 34, thereby coupling (e.g., attaching, fixing, etc.) the chuck 293 to the tubular guidewire member 34. Additionally, it may be desirable to couple (e.g., attach, fix, etc.) the chuck 293 to the actuating hypotube 78 such that translation of the actuating hypotube 78 (e.g., longitudinally) can cause translation of the coupling assembly 277 (which in turn can cause translation of both the actuating shaft 30 and the tubular guidewire member 34, as described above).

[0109] Figure 5A and 5B respectively illustrate two example coupling assemblies 177, 277. However, other designs of coupling assemblies can also be envisioned. For example, additional examples of coupling assemblies are disclosed in U.S. Patent Application No. 62 / 662,971, which is hereby expressly incorporated by reference in its entirety.

[0110] In some examples, the outer member 12 of the medical device system 10 can include one or more features that are designed to orient the outer member 12 with respect to the handle 17 in a specific configuration. For example, Figure 5C illustrates a cross - section of the body 59 taken along line 5C - 5C of the example seal assembly 52 discussed above. As discussed above, the post 48 can include a chamber 63 that is designed to receive the proximal end of the example outer member 12 therein. As shown in Figure 5 the chamber 63 can include an alignment recess 64 that, together with the overall profile of the chamber 63, is designed to align the curved portion 13 of the outer member 12 ( Figure 5C shown in Figure 1 ) with the body 59 (which in turn ultimately aligns with the handle 17). Additionally, Figure 5D illustrates a cross - section of the proximal region of the outer member 12. Figure 5D illustrates that the outer member 12 can include ribs 65 molded onto the outer surface of the outer member 12. It can be understood that the ribs 65 can be aligned with the curved portion 13 of the outer member 12. It can also be understood that the cross - sectional profile of the proximal end of the outer member 12 matches (e.g., mates with) the profile of the chamber 63 (which includes the alignment recess 64), as discussed above. In other words, positioning the ribs 65 within the alignment recess 64 can align the curved portion 13 of the outer member 12 with the handle 17 in a preferred orientation.

[0111] Additionally, Figure 5CThe tubular guidewire member 34 and the actuation shaft 30 are shown positioned within the lumen of the compression hypotube 44. Figure 5C As shown and described above, the tubular guidewire member 34 and the actuation shaft 30 may be positioned side-by-side, adjacent to one another.

[0112] Figure 6 An example exoskeleton seal assembly 54 is shown. The exoskeleton seal assembly 54 can include an exoskeleton seal body 66 coupled to a support ring 80. As discussed above, the exoskeleton seal assembly 54 can be fixed relative to the handle member 17. In other words, the exoskeleton seal body 66 and / or the support ring 80 can include one or more features that engage with the handle 17 to prevent the exoskeleton seal assembly 54 from moving relative to the handle 17.

[0113] The sealing body 66 may include a distal end 71 and a proximal end 82. In addition, the sealing body 66 may include a cavity 83 that extends through a portion or the entire length of the sealing body 66. In addition, the support ring 80 may include a distal end 68 and a proximal end 69. Figure 6 As shown, the proximal end 82 of the seal body 66 can be engaged with the distal end 68 of the support ring 80. For example, the support ring 80 can be engaged with the mating threaded portion of the seal body 66 (at Figure 6 In other words, the proximal end 82 of the sealing body 66 may include one or more threads that are designed to mate with one or more threads of the support ring 80. The threaded engagement of the sealing body 66 to the support ring 80 is not intended to be limiting. Rather, other engagement methods and / or designs are contemplated. For example, the support ring 80 may be engaged with the sealing body 66 via a press fit.

[0114] Figure 6 It is also shown that the compression hypotube 44 can extend into the sealing body 66 and terminate within the sealing body 66. The proximal end of the compression hypotube 44 can be securely fixed to the distal end of the sealing body 66. For example, Figure 6 The proximal end of the compression hypotube 44 is shown extending into a hole 85 located along the distal end 71 of the sealing body 66. In some examples, the compression hypotube 44 may be welded to the distal end 71 of the sealing body 66. Figure 6 The tubular guidewire member 34 is also shown extending within the lumen 76 of the actuation hypotube 78 .

[0115] Figure 6 It is also shown that the actuation hypotube 78 can extend within a portion of the cavity 83 of the exoskeleton seal assembly 54. As will be discussed in more detail below, the actuation hypotube 78 can terminate within the actuation seal assembly 56. In addition, the actuation hypotube 78 can translate relative to the exoskeleton seal assembly 54. Figure 6 It is also shown that the tubular guide wire member 34 can extend within the lumen 76 of the actuation hypotube 78. Additionally, as will be described in more detail below, Figure 6It is shown that the distal end of the guidewire hypotube 90 may terminate in the lumen 76 of the actuation hypotube 78. The guidewire hypotube 90 may be positioned between the inner surface of the actuation hypotube 78 and the outer surface of the tubular guidewire member 34.

[0116] Additionally, Figure 6 It is shown that the threaded support ring 80 can be designed to compress the seal 81 onto the actuation hypotube 78. For example, rotation of the support ring 80 can compress the seal 81 onto the outer surface of the actuation hypotube 78. In at least some examples, the seal 81 can be an X-ring type seal, however, other seal configurations are also contemplated. In the case where the actuation hypotube 78 translates through the seal 81, using an X-ring seal design for the seal 81 can reduce friction on the actuation hypotube 78.

[0117] Figure 6 It is also shown that the exoskeleton seal body 66 can include a first alignment surface 89a and / or a second alignment surface 89b. The first and second alignment surfaces 89a / 89b can align the exoskeleton seal body 66 in a specific orientation relative to the handle 17. It can be understood that aligning the seal body 66 relative to the handle 17 will also align any object attached to the seal body 66 in the same orientation relative to the handle. For example, it is contemplated that the compression hypotube 44 can be coupled to other components, elements, features, etc. Therefore, it is also contemplated that the first and second alignment surfaces 89a / 89b can not only align the compression hypotube 44 relative to the handle 17, but also align the components, elements, features, etc. coupled to the compression hypotube 44 relative to the handle 17. In addition, it can be understood that aligning the seal body 66 relative to the handle 17 can also align the compression hypotube 44 (and the components, elements, features, etc. coupled to the compression hypotube 44) with other features of the medical device 10 (such as, the curved portion 13 of the outer sheath 12).

[0118] Figure 6A It is along Figure 6 A cross-sectional view of the exoskeleton seal assembly 54 taken along line 6A-6A is shown in FIG. Figure 6A The exoskeleton seal body 66 is shown including a first alignment surface 89a and a second alignment surface 89b. Additionally, the seal body 66 shows the actuation hypotube 78 and the tubular guidewire member 34 extending within the lumen 83 of the seal body 66. Figure 6 It will be appreciated that the first and second alignment surfaces 89 a , 89 b may include substantially horizontal planar surfaces that extend across a majority of the diameter of the seal body 66 .

[0119] Figure 7 Another example exoskeleton seal assembly 354 is shown. The exoskeleton seal assembly 354 can be similar in form and function to the Figure 6The outer frame seal assembly 54. For example, the outer frame seal assembly 354 may include an outer frame seal body 366 coupled to the support ring 380. As described above with respect to Figure 6 As discussed, the exoskeleton seal assembly 354 can be fixed relative to the handle member 17. In other words, the exoskeleton seal body 366 and / or the support ring 380 can include one or more features that engage with the handle 17 to prevent the exoskeleton seal assembly 354 from moving relative to the handle 17. Additionally, similar to the exoskeleton seal assembly 54, the exoskeleton seal assembly 354 can include an actuation hypotube 378 that is similar in form and function to the actuation hypotube 78 described above.

[0120] Additionally, Figure 7 The exoskeleton seal assembly 354 is shown to include a compression hypotube 344. In addition, the compression hypotube 344 can include a first compression tubular member 367 and a second compression tubular member 368. As will be described in more detail below, at least a portion of the first compression tubular member 367 can be positioned within the lumen of the second compression tubular member 368. For example, in some cases, the first compression tubular member 367 can be concentric with the second compression tubular member 368.

[0121] In some cases, the first compressed tubular member 367 can be fixedly attached to the second compressed tubular member 368. However, in other cases, the first compressed tubular member 367 can be free relative to the second compressed tubular member 368. In other words, in some examples, the first tubular member 367 may be able to translate and / or rotate relative to the second tubular member 368.

[0122] Figure 7 366. As shown, in some examples, the first compression tubular member 367 can extend in a proximal direction and terminate in a recess 374 located in the exoskeleton seal body 366. In other words, the proximal end of the first compression tubular member 367 can extend beyond the proximal end of the second compression tubular member 368, thereby being fixedly attached to the exoskeleton seal body 366 within the recess 374.

[0123] Figure 7 It is also shown that the exoskeleton seal body 366 can include a hole 372 that allows wires 369 (e.g., a flexible circuit, an electrical component, a wire, etc.) to pass through (e.g., exit) from a location inside the exoskeleton seal body 366 to a location outside the exoskeleton seal body 366. The hole 372 can extend through the wall of the exoskeleton seal body 366. In addition, the hole 372 can be filled with epoxy (or a similar material) to seal the interior of the exoskeleton seal body 366 from fluids surrounding the outer surface of the exoskeleton seal body 366.

[0124] like Figure 7 As shown in (andFigure 8 and Figure 9 As further shown in Figure 9 , wire 369 can extend between the first compression tubular member 367 and the second compression tubular member 368 along the entire length of the compression bellows tube 344. It can be understood that the first compression tubular member 367 can shield (e.g., isolate, separate, etc.) the wire 369 from the movement of the actuating bellows tube 378. Additionally, the first compression tubular member 367 can act as a "force reduction surface" to minimize the potential frictional force generated between the relative movement of the first compression tubular member 367 and the actuating bellows tube 378. Similarly, the second compression tubular member 368 can be used to minimize the potential frictional force generated between the relative movement of the second compression tubular member 368 and the outer sheath seal assembly 52.

[0125] Figure 8 is a cross-sectional view taken along line 8-8 of Figure 7 As shown in Figure 7 . The compression bellows tube 344 can include a first compression tubular member 367, which is positioned within the cavity of the second compression tubular member 368. As described above, the first compression tubular member 367 can be positioned concentrically relative to the second compression tubular member 368. Additionally, Figure 8 Figure 8 shows the wire 369 positioned between the outer surface of the first compression tubular member 367 and the inner surface of the second compression tubular member 368. It can be understood that although Figure 8 shows a space (e.g., gap) between the outer surface of the first compression tubular member 367 and the inner surface of the second compression tubular member 368, it is contemplated that the outer surface of the first compression tubular member 367 can contact (and / or be directly attached to) the inner surface of the second compression tubular member 368. Figure 8 Figure 8 shows a cross-sectional view taken along line 8-8 of another example compression bellows tube 444. The example compression bellows tube 444 can be similar in form and function to the compression bellows tube 344 described above. For example, the compression bellows tube 444 can include a first compression tubular member 467, which is positioned within the cavity of the second compression tubular member 468. Figure 8 Figure 8 shows a cross-sectional view taken along line 8-8 of another example compression bellows tube 444. The example compression bellows tube 444 can be similar in form and function to the compression bellows tube 344 described above. For example, the compression bellows tube 444 can include a first compression tubular member 467, which is positioned within the cavity of the second compression tubular member 468.

[0126] Figure 9 Figure 9 shows along another example compression bellows tube 444 Figure 7 Figure 7 of line 8-8 taken cross-sectional view. The example compression bellows tube 444 can be similar in form and function to the compression bellows tube 344 described above. For example, the compression bellows tube 444 can include a first compression tubular member 467, which is positioned within the cavity of the second compression tubular member 468.

[0127] Additionally, Figure 9In some examples, the first compression tubular member 467 is shown to include a channel (e.g., a groove, etc.) designed to receive the wire 469. The channel can be shaped in a variety of configurations, all of which can be designed to create a space in which the wire 469 can be positioned between the outer surface of the first compression tubular member 467 and the inner surface of the second compression tubular member 468. It will be appreciated that the channel can extend along a portion or the entire length of the first compression hypotube 467. In addition, it will be appreciated that the channel can be aligned with the hole 372 of the exoskeleton seal body 366.

[0128] In addition, although not in Figure 7 , but it is contemplated that the first compressed tubular member 467 and / or the second compressed tubular member 468 may include one or more “orienting” features designed to align the first compressed tubular member 467 with the second compressed tubular member 468 and / or to align any of the features of the first compressed tubular member 467 (e.g., a channel) and / or the second compressed tubular member 468 with one or more features of the exoskeleton seal body 366 (or any other component of the medical system 10). For example, the first compressed tubular member 467 and / or the second compressed tubular member 468 may include one or more features designed to align the channel with the aperture 372 of the exoskeleton seal body 366.

[0129] In some examples, the first compression tubular member 367 / 467 and / or the second compression tubular member 368 / 468 can be formed of a variety of materials. For example, the first compression tubular member 367 / 467 and / or the second compression tubular member 368 / 468 can be formed of metal, polymer, or any combination thereof. In some cases, the first compression tubular member 367 / 467 can include a flexible lining designed to provide a lubricating layer between the wire 369 and the actuation hypotube 378.

[0130] Figure 10 The actuation member seal assembly 56 is shown. The actuation seal assembly 56 may include an actuation seal body 92 and a support ring 86. The actuation seal body 92 may include a distal end 93, a proximal end 94, and a cavity 95 extending therethrough. Figure 10 As shown in FIG. 8 , the actuation hypotube 78 may enter and terminate within a hole 75 located along a distal end 93 of the actuation seal body 92 .

[0131] Similar to that described above, the support ring 86 utilized in the actuation member seal assembly 56 may be engaged with a mating threaded portion of the actuation seal body 92 (at Figure 10In other words, the proximal end of the sealing body 92 may include one or more threads that are designed to mate with one or more threads of the support ring 86. The threaded engagement of the sealing body 92 to the support ring 86 is not intended to be limiting. Rather, other engagement methods and / or designs are contemplated. For example, the support ring 86 may be engaged with the sealing body 92 via a press fit.

[0132] Additionally, Figure 10 It is shown that the threaded support ring 86 can be designed to compress the seal 88 onto the actuation hypotube 78. For example, rotation of the support ring 86 can compress the seal 88 onto the outer surface of the actuation hypotube 78. In at least some examples, the seal 88 can be an X-ring type seal, however, other seal configurations are also contemplated. In the case where the actuation hypotube 78 translates through the seal 88, using an X-ring seal design for the seal 88 can reduce friction on the actuation hypotube 78.

[0133] As discussed above, the actuation hypotube 78 can be connected via the coupling assembly 77 (described above with respect to Figure 5 The actuating shaft 30 and the tubular guide wire member 34 are connected. In addition, the actuating shaft 30 can be connected to the tubular guide wire member 34 via the coupling 28 (in Figure 2 and Figure 3 ) is coupled to the translating member 24, while the tubular guidewire member 34 can be coupled to the nose cone 36. Thus, it can be appreciated that actuation of the actuation seal assembly 56 (and correspondingly, the actuation hypotube 78 also coupled to the coupling assembly 77) in the distal to proximal direction can actuate the translating member 24 and the nose cone 36 in the distal to proximal direction. As discussed above, the distal to proximal movement of the translating member 24 can cause the implant 16 to move from its position in the distal direction to the proximal direction. Figure 2 The length "L1" shown in Figure 3 In some cases, the distal-to-proximal movement of the actuated seal assembly 56 can be accomplished by moving the handle 17 (in Figure 10 (not shown) control.

[0134] Figure 10 Also shown is a guidewire hypotube 90 extending within the lumen 95 of the actuation seal member 56. The guidewire hypotube 90 may be a fixed hypotube. In other words, in some examples, the guidewire hypotube 90 may be fixed relative to the handle member 17 (in the Figure 10 76 ). Additionally, it will be appreciated that the guidewire hypotube 90 may extend into the lumen 76 of the actuation hypotube 78. Thus, it will also be appreciated that the actuation hypotube 78 may travel along the outer surface of the guidewire hypotube 90 when the actuation seal assembly 56 is actuated (as discussed above).

[0135] Figure 11 1 and 10. The guidewire tubing seal assembly 58 is shown. The guidewire seal assembly 58 may include a guidewire seal body 97. The guidewire seal body 97 may be rigidly fixed to the handle member 17 (at Figure 11 (not shown). In addition, the guidewire seal body 97 may include a lumen 98 extending therethrough. Figure 11 As shown in , the guidewire seal body 97 can be coupled to the proximal guidewire tube 90. In some examples, the proximal guidewire tube 90 can be welded (eg, hermetically welded) to a portion of the guidewire seal body 97.

[0136] Additionally, Figure 11 1 and 2. The tubular guidewire member 34 is shown as a location where it may terminate within the lumen of the guidewire hypotube 90. For example, Figure 11 The tubular guidewire member 34 is shown terminating within the lumen 96 of the guidewire hypotube 90 .

[0137] Additionally, from Figure 11 It is understood that the lumen 98 of the guidewire seal 97 can be fluidly connected to the lumen 96 of the proximal guidewire tube 90. This fluid communication path can allow a guidewire (not shown) to be inserted through the guidewire seal 97 and into the lumen 96 of the proximal guidewire tube 90. In addition, Figure 11 Shown that guidewire seal body 97 comprises guidewire sealing channel 99, and it has the diameter that is depicted as " X ".It is to be understood that, in at least some examples, diameter " X " can be designed to allow guidewire to pass through, and also provide minimum clearance simultaneously, so that fluid is not allowed to pass through it.In other words, the clearance between the outer diameter of guidewire (not shown) and the diameter " X " of channel 99 can be designed to prevent fluid from leaking out from guidewire seal body 97.

[0138] Materials that can be used for the various components of the medical devices and / or systems 10 disclosed herein may include those commonly associated with medical devices. However, this is not intended to limit the devices and methods described herein, as the discussion can be applied to other components of the medical devices and / or systems 10 disclosed herein, including various shafts, liners, and components described with respect thereto.

[0139] The medical device 10 can be made of metals, metal alloys, polymers (some of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials. Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available from DuPont, for example). ) polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether or ester group copolymers (e.g., butene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as available from DuPont ), polyamides (e.g., available from Bayer or available from Elf Atochem ), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name ), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), high density polyethylene (HDPE), polyesters, Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., ), ultra high molecular weight (UHMW) polyethylene, polypropylene, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS)), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfones, nylons, nylon-12 (such as available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrenes, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP).

[0140] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625, UNS:N06022, such as UNS:N10276, such as others alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel - cobalt - chromium - molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel - molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), other nickel - chromium alloys, other nickel - molybdenum alloys, other nickel - cobalt alloys, other nickel - iron alloys, other nickel - copper alloys, other nickel - tungsten or tungsten alloys, etc.; cobalt - chromium alloys; cobalt - chromium - molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum - rich stainless steels; titanium; combinations thereof; etc.; or any other suitable material.

[0141] In at least some embodiments, some or all of the medical device 10 may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials are understood to be capable of producing a relatively bright image on a fluoroscopy screen or with another imaging technique during a medical procedure. This relatively bright image helps a user of the medical device 10 to determine its position. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device 10 to achieve the same result.

[0142] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the medical device 10. For example, the medical device 10 may include materials that substantially do not distort the image and create a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be inappropriate because they may create artifacts in the MRI image. The medical device 10 may also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt - chromium - molybdenum alloys (e.g., UNS: R30003, such as etc.), nickel - cobalt - chromium - molybdenum alloys (e.g., UNS: R30035, such as etc.), nitinol, etc.

[0143] It should be understood that the present invention is merely illustrative in many respects. Changes may be made in details, particularly in matters of the shape, size, and arrangement of steps, without exceeding the scope of the invention. To an appropriate extent, this may include using any of the features of one exemplary embodiment in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A system for delivering an implantable medical device, which comprises: a handle member including a sealing assembly, wherein the sealing assembly comprises: an outer sheath sealing assembly coupled to an outer sheath, the outer sheath sealing assembly being translatable relative to the handle and including a first alignment surface; a first fixed sealing assembly fixed relative to the handle; and a compression shaft coupled to the first fixed sealing assembly; wherein the first alignment surface is designed to align the compression shaft with at least a portion of the outer sheath; wherein the outer sheath sealing assembly includes a first seal, and wherein the first seal is disposed along an outer surface of the outer sheath; wherein the outer sheath sealing assembly includes a second seal, and wherein the second seal is disposed along an outer surface of the compression shaft.

2. The system according to claim 1, wherein the first fixed sealing assembly is positioned proximal to the outer sheath sealing assembly.

3. The system according to claim 1, wherein the sealing assembly further includes an actuation sealing assembly positioned proximal to the first fixed sealing assembly, the actuation sealing assembly being translatable relative to the handle, and wherein actuation of the actuation sealing assembly is designed to transition the implantable medical device between a first position and a second expanded position.

4. The system according to claim 3, wherein the sealing assembly further includes a second fixed sealing assembly fixed relative to the handle and positioned proximal to the actuation sealing assembly.

5. The system according to claim 1, wherein the outer sheath includes a curved portion, and wherein the first alignment surface is designed to align the compression shaft with the curved portion of the outer sheath.

6. The system according to claim 5, wherein the outer sheath includes a protruding portion, wherein the protruding portion is aligned with the curved portion of the outer sheath, and wherein the first alignment surface includes a recess designed to engage with the protruding portion.

7. The system according to claim 1, wherein the compression shaft extends at least partially within a cavity of the outer sheath sealing assembly.

8. The system according to any one of claims 3 to 4, wherein the system further includes an actuation shaft coupled to the actuation sealing assembly, and wherein the actuation shaft extends at least partially within a cavity of the first fixed sealing assembly.

9. The system according to claim 8, wherein the first fixed sealing assembly includes a third seal, and wherein the third seal is disposed along an outer surface of the actuation shaft.

10. The system according to claim 4, wherein the system further includes a guide wire shaft coupled to the second fixed sealing assembly, and wherein the guide wire shaft extends at least partially within a cavity of the actuation sealing assembly.

11. The system according to claim 10, wherein the actuation sealing assembly includes a fourth seal, and wherein the fourth seal is disposed along an outer surface of the guide wire shaft.

12. A system for delivering an implantable medical device, which comprises: A handle member, the handle member including a telescoping seal assembly, wherein the telescoping seal assembly includes: An outer sheath seal assembly coupled to an outer sheath that covers at least a portion of the implantable medical device, the outer sheath seal assembly being translatable relative to the handle and including a first alignment surface; A first fixed seal assembly that is fixed relative to the handle; A compression shaft coupled to the first fixed seal assembly; and An actuation seal assembly that is translatable relative to the handle; wherein the first alignment surface is designed to align the compression shaft with at least a portion of the outer sheath; wherein the outer sheath seal assembly includes a first seal, and wherein the first seal is disposed along an outer surface of the outer sheath; wherein the outer sheath seal assembly includes a second seal, and wherein the second seal is disposed along an outer surface of the compression shaft.

13. The system of claim 12, wherein the actuation seal assembly is designed to transition the implantable medical device between a first position and a second expanded position.

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