Valve locking mechanism

Cross reference to related applications for valve locking mechanism

[0001] This document asks for the rights of T-US Provisional Patent No. 62/082,946 filed on November 21, 2014.

Technical field

[0002] The present disclosure relates to medical devices and methods for manufacturing and/or using medical devices. More specifically, the present disclosure relates to a locking mechanism for replacing heart valves.

Background technique

[0003] A wide variety of in-vivo medical devices have been developed for medical purposes (for example, related intravascular uses). Some of these devices include guide wires, catheters, medical device delivery systems (for example, for stents, grafts, replacement valves, etc.). These devices are manufactured by any of a variety of different manufacturing methods, and can be used according to any of a variety of methods. Regarding the known medical devices and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and using medical devices.

Summary of the invention

[0004] In a first aspect, a valve replacement implant can include an expandable anchoring member having a proximal end and a distal end, the anchoring member can be driven between a delivery configuration and a deployment configuration. The valve replacement implant may include a plurality of locking mechanisms for fixing the anchoring member in the deployment configuration; each locking mechanism includes: an axially movable post with legs extending inwardly therefrom; and being fixed To the receiving part of the anchoring member, the receiving part is for slidably receiving the post. The valve replacement implant may include a plurality of valve leaflets disposed inside the central cavity of the anchoring member, the plurality of valve leaflets being fixed to the legs of the plurality of locking mechanisms, wherein the plurality of locking mechanisms are removably attached to the delivery Device.

[0005] Additionally or alternatively, and in the second aspect, the leg extends from the post toward the proximal end.

[0006] Additionally or alternatively, and in the third aspect, the leg is attached to the post at the distal end of the post.

[0007] Additionally or alternatively, and in the fourth aspect, the leg is flexibly attached to the post.

[0008] Additionally or alternatively, and in the fifth aspect, the leg includes a free end and a fixed end, and the leg is attached to the post at the fixed end.

[0009] Additionally or alternatively, and in the sixth aspect, the free end is not attached to any other structure except for the legs.

[0010] Additionally or alternatively, and in the seventh aspect, at least part of the leg portion longitudinally overlaps the receiving portion along the longitudinal center axis of the anchor member in the arrangement configuration.

[0011] Additionally or alternatively, and in the eighth aspect, a plurality of valve leaflets are directly fixed to the leg.

[0012] Additionally or alternatively, and in the ninth aspect, the plurality of valve leaflets are not directly fixed to the post.

[0013] Additionally or alternatively, and in the tenth aspect, the anchoring member is driven between the delivery configuration and the deployment configuration by translating the post proximally relative to the receiving portion.

[0014] Additionally or alternatively, and in the eleventh aspect, the post includes two legs extending inwardly therefrom.

[0015] Additionally or alternatively, and in the twelfth aspect, the two legs are connected to a

Up.

[0016] Additionally or alternatively, and in the thirteenth aspect, the two legs are generally arranged parallel to each other.

[0017] Additionally or alternatively, and in the fourteenth aspect, at least part of the plurality of valve leaflets pass between the two legs.

[0018] Additionally or alternatively, and in the fifteenth aspect, at least part of the plurality of valve leaflets passing between the two legs is wrapped around the two legs.

[0019] Additionally or alternatively, and in the sixteenth aspect, at least part of the plurality of valve leaflets passing between and around the two legs are fixed back to themselves.

[0020] Additionally or alternatively, and in the seventeenth aspect, one or more sutures are utilized to secure at least part of the plurality of valve leaflets posteriorly to themselves.

[0021] Additionally or alternatively, and in the eighteenth aspect, at least part of the plurality of valve leaflets are fixed back to themselves with an adhesive.

[0022] Additionally or alternatively, and in the nineteenth aspect, the most distal end of the post is coupled to the distal end of the anchoring member.

[0023] Additionally or alternatively, and in the twentieth aspect, the most distal end of the plurality of valve leaflets is coupled to the distal end of the anchoring member.

[0024] The above summary of some embodiments, aspects, and/or examples is not intended to describe each disclosed embodiment or every embodiment of the present disclosure. The following figures and detailed description exemplify these embodiments in more detail.

Description of the drawings

[0025] The present disclosure can be more fully understood based on the following detailed description in conjunction with the accompanying drawings. In the accompanying drawings:

[0026] FIG. 1 is a schematic side view of an exemplary medical device system;

[0027] FIG. 2 is a perspective view of a portion of an exemplary implant associated with an exemplary medical device system in a deployed configuration;

[0028] FIG. 3 shows selected components of an exemplary implant associated with an exemplary medical device system in a delivery configuration;

[0029] FIG. 4 shows an exemplary implant associated with an exemplary medical device system in a deployed configuration;

[0030] FIG. 5 shows selected components of an exemplary implant associated with an exemplary medical device system further shifted from the deployed configuration toward the released configuration;

[0031] FIG. 6 shows selected components of an exemplary implant associated with an exemplary medical device system further shifted from the deployed configuration toward the released configuration;

[0032] FIG. 7 shows selected components of an exemplary implant associated with an exemplary medical device system in a delivery configuration;

[0033] FIG. 8 shows selected components of an exemplary implant associated with an exemplary medical device system in a deployed configuration;

[0034] FIG. 9 shows selected components of an exemplary implant associated with an exemplary medical device system in a delivery configuration;

[0035] FIG. 10 shows selected components of an exemplary implant associated with an exemplary medical device system in a deployed configuration;

[0036] FIG. 11 shows a selection of an exemplary implant associated with an exemplary medical device system in a delivery configuration

Optional parts;

[0037] FIG. 12 shows selected components of an exemplary implant associated with an exemplary medical device system in a deployed configuration;

[0038] FIG. 13 shows selected components of an exemplary implant associated with an exemplary medical device system in a delivery configuration;

[0039] FIG. 14 shows selected components of an exemplary implant associated with an exemplary medical device system in a deployed configuration;

[0040] FIG. 15 shows selected components of an exemplary implant associated with an exemplary medical device system in a delivery configuration;

[0041] FIG. 16 shows selected components of an exemplary implant associated with an exemplary medical device system in a deployed configuration.

[0042] Although the present disclosure is suitable for various modifications and alternative forms, its details have been disclosed through examples in the drawings and will be described in detail. However, it should be understood that the intention is not to limit the invention to the specific embodiments described. On the contrary, the intention is to include all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

Detailed ways

[0043] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, in which similar reference numerals indicate similar elements in all several views. The detailed description and drawings are used to illustrate but not limit the claimed invention. Those skilled in the art will recognize that the various elements described and/or illustrated may be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings illustrate exemplary embodiments of the claimed invention.

[0044] For the terms defined below, these definitions shall be used, unless a different definition is given in the claims or elsewhere in this document.

[0045] All numerical assumptions in this document are modified by the term "about", whether or not explicitly stated. The term "about" in the context of numerical values generally refers to a series of numbers that those skilled in the art would consider equivalent to the listed value (ie, having the same function or result). In many cases, the term "about" can include numbers that are rounded to the nearest significant figure. Other uses of the term "about" (ie, in a context other than a numerical value) may assume their ordinary and usual definitions, as understood based on and consistent with the context of the present invention, unless otherwise stated.

[0046] The description of numerical ranges using endpoints includes all numbers within that range, including the endpoints (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0047] As used in this and appended claims, the singular forms "a", "an", and "the" include plural referents unless clearly indicated in the context. The term "or" used in the present and appended claims is generally used in its meaning including "and/or" unless clearly indicated in the context.

[0048] Relative terms such as "proximal", "distal", "advance", "retreat", and variants thereof can generally be considered to refer to various elements relative to the user/operator of the device. The positioning, direction, and/or operation of the operator, where "proximal" and "retreat" mean or mean closer to or toward the user, and "distal" and "forward" mean or mean further away from the user.

[0049] It should be noted that quoting "one embodiment", "some embodiments", "other embodiments", etc. in this specification means that the described embodiments may include specific features, structures, or characteristics, but Each embodiment may not necessarily include the specific

The characteristics, structure, or characteristics of. Furthermore, such phrases are not necessarily referring to the same embodiment. In addition, when a specific feature, structure, or characteristic is described in conjunction with one embodiment, it will be combined with other embodiments within the knowledge of those skilled in the art to implement such feature, structure, or characteristic, whether explicitly or not. Describe, unless the contrary is clearly stated. That is to say, although the following individual elements are not explicitly shown in a specific combination, it is conceivable that they can be combined or combined with each other to form other complementary embodiments or supplement and/or enrich the described implementation For example, as will be understood by those skilled in the art.

[0050] Diseases and/or conditions affecting the vascular system are ubiquitous in the United States and the world. Traditionally, treatment of the cardiovascular system is often performed by directly accessing the affected part of the system. For example, the treatment of blockages in one or more coronary arteries is traditionally treated by coronary artery bypass surgery. As can be easily understood, this treatment is quite traumatic for the patient and requires a lot of recovery time and/or treatment. Recently, less invasive therapies have been developed, for example, in which a percutaneous catheter (for example, angioplasty) can be used to enter the blocked coronary artery for treatment. This therapy has been widely recognized by patients and clinicians.

[0051] Some relatively common conditions may include, or be the result of, inefficiency, inefficiency, or complete failure of one or more valves inside the heart. For example, the failure of the aortic valve can have a serious impact on people, and if left untreated, it can lead to serious health conditions and/or death. The treatment of defective heart valves poses other challenges, that is, the treatment often requires repair or complete replacement of the defective valve. This therapy can be highly traumatic for the patient. Disclosed herein are medical devices that can be used to deliver a medical device to a part of the cardiovascular system to diagnose, treat, and/or repair the system. At least part of the medical devices disclosed herein can be used to deliver and implant replacement heart valves (eg, replacement aortic valves). In addition, the device disclosed herein can deliver the replacement heart valve percutaneously, so the trauma to the patient will be much less. The devices disclosed herein may also provide several other desirable features and benefits as described in more detail below.

[0052] FIG. 1 is a side view of an exemplary medical device system 10. It should be noted that, for the sake of simplicity, some features of the medical device system 10 are not shown or schematically shown in FIG. 1. In other drawings, other details about some components of the medical device system 10 are provided in more detail. The medical device system 10 can be used to deliver and/or arrange a variety of medical devices to some locations inside the anatomical structure. In at least some embodiments, the medical device system 10 may be a replacement heart valve delivery system (eg, a replacement aortic valve delivery system) that can be used for percutaneous delivery of replacement heart valves. However, this is not intended to be limiting, as the medical device system 10 may also be used for other interventions, including mitral valve replacement, valve repair, valvuloplasty, etc., or other similar interventions.

[0053] The medical device system 10 can generally be described as including a catheter or outer sheath 12 and a tube or inner catheter 14 that slidably extends at least partially through the outer sheath 12 (which is shown in phantom lines in FIG. 1 Part) of the catheter system. During the delivery of the medical implant 16, the medical implant 16 (ie, for example, a valve replacement implant) may be coupled to the inner catheter 14 and disposed inside the lumen of the outer sheath 12. The handle 18 may be provided at the proximal end of the outer sheath 12 and/or the inner catheter 14. Generally speaking, the handle 18 may be configured to manipulate the position of the outer sheath 12 relative to the inner catheter 14 and to assist in the placement of the medical implant 16.

[0054] In use, the medical device system 10 can be advanced percutaneously through the vasculature to reach a position adjacent to the region of interest. For example, the medical device system 10 can be advanced through the vasculature and through the aortic arch to a location adjacent to the defective aortic valve (or other heart valve). During delivery, the medical implant 16 can generally be placed inside the outer sheath 12 in an elongated and low-profile "delivery" configuration (eg, partially shown in FIG. 1). Once positioned, the outer sheath 12 can be withdrawn to expose the medical implant 16. The medical implant 16 can be driven so that the medical implant 16 radially expands to a generally shortened and larger cross-sectional "arrangement" configuration suitable for implantation inside an anatomical structure (for example, as shown in FIG. 2

Show). When the medical implant 16 is properly arranged inside the anatomical structure, the medical device system 10 can be removed from the vasculature, so that the medical implant 16 can be left in place in a "released" configuration for use, for example. For the proper replacement of the natural aortic valve. In at least some interventions, the medical implant 16 may be placed inside the natural valve (eg, leaving the natural valve in place and not removed). Alternatively, the natural valve can be removed, and the medical implant 16 can be placed in its place as a replacement.

[0055] In some embodiments, the outer sheath 12 may have a proximal end and a distal end. In some embodiments, the distal portion may have a slightly expanded or expanded inner diameter, which may provide additional space for housing the medical implant 16 therein. E.g, In some embodiments, the inner diameter of the outer sheath 12 along the proximal end may be about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1,016 cm (0.20 to 0.40 inches), or about 0.508 Within the range of 0.762cm (0.20 to 0.30 inches), or about 0.56388±0.0508cm (0.222±0.002 inches). In some embodiments, the inner diameter of the outer sheath 12 along the distal end may be about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1,016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.579 to 0.5842 cm (0.228 to 0.230 inches). The distal end at the distal portion may be a distal tip, which is expandable or has a funnel-like shape. This funnel-like shape can increase the outer diameter (and inner diameter) of the outer sheath 12 at the distal tip, and can help wrap and/or re-wrap the medical implant 16 into the outer sheath 12. Except at the distal tip, the outer sheath 12 may have a generally constant outer diameter. For example, in some embodiments, the outer sheath 12 may have a thickness of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1,016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.6858 cm (0.270 inches) outside diameter. These are just examples. Other embodiments with different sizes (including sizes suitable for patients of different sizes (including but not limited to children)) and/or arrangements for the outer diameter and/or inner diameter of the outer sheath 12 are conceivable. These conceivable embodiments include outer sheaths with expanded or variable outer diameters, embodiments with constant inner diameters, combinations thereof, and the like. The outer sheath 12 may also have a length suitable for reaching the expected area of interest inside the anatomical structure. For example, the outer sheath 12 may have a length in the range of about 30 to 200 cm, or about 60 to 150 cm, or about 100 to 120 cm, or about 108 + 0.20 cm. In some embodiments, some, all, or part of the outer sheath 12 may also be curved. For example, in some embodiments, the distal section of the outer sheath 12 may be curved. In one example, the radius of curvature (measured from the center of the outer sheath 12) may be in the range of about 2 to 6 cm (20 to 60 mm), or about 3 to 4 cm (30 to 40 mm), or about 3.675 cm ( 36.75mm). In addition, these dimensions are examples and are not intended to be limiting.

[0056] In some embodiments, the outer sheath 12 may be composed of a singular monolithic tube or monolithic component. Alternatively, the outer sheath 12 may include multiple layers or portions. In some embodiments, one or more of these layers may include reinforcement structures, such as braids, loops, meshes, combinations thereof, and the like. In some embodiments, a reinforcement member or a reinforcement layer may be provided on the intermediate layer. In some embodiments, an outer coating (eg, lubricity coating, hydrophilic coating, hydrophobic coating, etc.) may be provided along part or all of the outer layer. These are just examples. Other alternative structural configurations are also conceivable.

[0057] The size and materials of the various layers used for the outer sheath 12 may also vary. For example, the inner layer may include a polymer material such as fluorinated ethylene propylene (FEP), and may have a thickness in the range of about 0.00254 to 0.0127 cm (0.001 to 0.005 inches) or about 0.00762 ± 0.00254 (0.003 ± 0.001 inches). The layer may comprise a polymer material such as polyamide block amide (for example, PEBAX 6333), and may have a thickness in the range of about 0.00254 to 0,0127 cm (0.001 to 0.005 inches), or about 0.00508 ± 0.00254 (0.002 ± 0.001 inches) Thickness, the outer layer may include a polymer material such as polyamide block amide (for example, PEBAX 7233) and may have a thickness in the range of about 0.00254 to 0.0254 cm (0.001 to 0.01 inches). In some embodiments, the thickness of the outer layer can vary. For example, along the proximal portion, the outer layer may have a greater thickness than along the distal portion and/or at the distal tip, such as about 0.0127 to about 0.0508 cm or about 0.02159 cm (0.005 to

0.02 inches or about 0.0085 inches), the thickness along the distal end and/or at the distal tip may be about 0.0127 to about 0.0508 cm or about 0,01651 cm (for example, about 0.005 to 0.02 inches or about 0.0065 inches). These are just examples, as other suitable materials can be used.

[0058] The shape of the distal tip can also vary. For example, in at least some embodiments, the inner liner layer (ie, for example, a 2.5 mm section thereof) may extend to and around the distal end of the outer sheath 12. In some embodiments, a ring member (not shown) made of a suitable material such as 55D polyoxane block amide (for example, 55D PEBAX) may be placed over the inner layer and thermally bonded to form the distal tip. In some embodiments, this can form a funnel-like shape of the distal tip.

[0059] In some embodiments, the reinforcement or reinforcement layer may take the form of a braid, loop, mesh, or the like. For example, in some embodiments, the reinforcement or reinforcement layer may include a metal braid (eg, stainless steel). In some of these embodiments, the reinforcement member or the reinforcement layer may also include another structure, such as one or more longitudinally extending strands. For example, the reinforcement or the reinforcement layer may include a pair of longitudinally extending aramid and/or para-aramid strands (eg, KfSVLAR) arranged on opposite sides of the braid. These strands may or may not be woven into Part or all of the braid.

[0060] In some embodiments, the distal region of the inner catheter 14 may include a stepped outer diameter that defines a reduced outer diameter portion. For example, the reduced outer diameter portion may have a range of about 0.127 to 0.635 cm (0.05 to 0.25 inches), or about 0.254 to 0.508 cm (0.10 to 0.20 inches), or about 0.38608±0,00762 (0.152±0,003 Inches), as opposed to the rest of the inner duct 14, where the outer diameter can be in the range of about 0.127 to 0.762 cm (0.05 to 0.30 inches), or about 0.254 to 0.635 cm (0.10 to 0.25 inches), or about 0,508±0.0254cm (0.20±0.01 inches). In some embodiments, the reduced outer diameter portion may define an area where other components of the medical device system 10 may be attached.

[0061] Generally speaking, the inner conduit 14 may take the form of an extruded polymer tube. Other forms are also conceivable, including other polymer pipes, metal pipes, reinforced pipes, etc., containing other suitable materials such as those disclosed herein. In some embodiments, the inner catheter 14 is a singular unitary or unitary member. In other embodiments, the inner catheter 14 may include multiple parts or sections that are coupled together. The total length of the inner catheter 14 may be in the range of about 60 to 150 cm, or about 80 to 120 cm, or about 100 to 115 cm, or about 112 ± 0.02 cm_oJust like the outer sheath 12, in some embodiments, the inner catheter 14 may also be curved, for example adjacent to its distal end. In some embodiments, the inner catheter 14 may include one or more sections or regions with different hardness/stiffness (eg, different Shore durometers). For example, in some embodiments, the inner catheter 14 may have a proximal region and an intermediate region. The proximal region may comprise a generally rigid polymer material, such as 72D polyamide block amide (for example, 72D PEBAX), and may have a range of about 60 to 150 cm, or about 80 to 120 cm, or about 100 to 115 cm. Inside, or about 109.5±0.02cm in length. The middle zone may comprise a 40D polybronide block amide (for example, 40D PEBAX), and may have a length in the range of about 5 to 25 mm, or about 10 to 20 mm, or about 15 ± 0.01 mm. In some embodiments, the reduced outer diameter section may also be different from the proximal region and/or the middle region, and in some embodiments may include 72D polyoxon block amide (eg, 72D PEBAX) and may have a range of about 0.5 to 2 cm (5 to 20mm), or about 0.8 to 1.5cm (8 to 15mm) in the range, or about 1 soil 0.001cm (10 ±0.01mm) in length. These are just examples.

[0062] In some embodiments, the inner catheter 14 may include one or more lumens extending therethrough. For example, in some embodiments, the inner catheter 14 may include a first lumen, a second lumen, a third lumen, and a fourth lumen. Generally, one or more lumens extend along the entire length of the inner catheter 14. However, other embodiments are conceivable in which one or more of the one or more lumens extends only along a portion of the length of the inner catheter 14. For example, in some embodiments, the fourth lumen can be stopped at a position close to the distal end of the inner catheter 14 and/or filled at its distal end, thereby effectively reducing the fourth lumen adjacent to the distal end of the inner catheter 14 termination.

[0063] Disposed inside the first lumen of the inner catheter 14 may be at least one drive element (such as a push-pull rod 84), which may be used to drive (ie, expand and/or pull) between the delivery configuration and the deployment configuration. Long) Medical implant 16. In some cases, the push-pull rod 84 may be referred to herein as the term "driving element", or used interchangeably with the term "driving element". In other words, the medical device system 10 may include at least one push-pull rod 84. In some embodiments, the at least one push-pull rod 84 may include two push-pull rods 84, three push-pull rods 84, four push-pull rods 84, or another suitable or desired number of push-pull rods 84. For illustrative purposes only, the medical device system 10 and/or the medical implant 16 are illustrated as having three push-pull rods 84.

[0064] In at least some embodiments, the first lumen may be lined with a low-friction lining material (for example, FEP lining material). Provided inside the second lumen may be a pin release mandrel 92 explained in more detail herein. In at least some embodiments, the second lumen can be lined with a hypotube lining material. The third lumen can be a guide wire lumen, and in some embodiments, the third lumen can also be lined with a hypotube lining material. In some embodiments, the fourth lumen can be used to accommodate non-stretchable filaments. The form of the non-stretchable yarn can vary. In some embodiments, the non-stretchable wire may take the form of a stainless steel braid. The non-stretchable yarn may optionally include a pair of longitudinally extending aramid and/or para-aramid strands (eg, KEVLARS) arranged on the opposite side of the braid. Generally speaking, except for being arranged in the fourth "Inside the lumen", it is also possible to embed the non-stretchable wire in the fourth lumen. In addition, the non-stretchable wire may extend to a position adjacent to the distal region, but does not extend completely to the distal end of the inner catheter 14. For example, the short distal section of the fourth lumen can be filled with a polymer material adjacent to the distal end of the inner catheter 14.

[0065] The inner catheter 14 may also include a guidewire tube extension that extends distally from the distal region. In some embodiments, the nose cone may be attached to the guide wire tube extension. In some embodiments, the nose cone is generally designed to have an atraumatic shape. In some embodiments, the nose cone may also include a ridge or protrusion for abutting the distal tip of the outer sheath 12 during the delivery of the medical implant 16.

[0066] FIG. 2 shows some selected components of the medical device system 10 and/or the medical implant 16. For example, it can be seen here that the medical implant 16 can include a plurality of valve leaflets 68 (eg, bovine pericardium) that can be secured to a cylindrical anchoring member or braid 70, which can be in a "delivery" configuration Reversible drive between and "arrangement" configuration. In some embodiments, the medical implant 16 may include multiple locking mechanisms for securing the anchoring member or braid 70 in the "arranged" configuration. In some embodiments, at least one drive element (ie, push-pull rod 84) may be used to engage multiple locking mechanisms and drive the anchoring member or braid 70 between the "delivered" configuration and the "arranged" configuration. In some embodiments, a drive element may correspond to, engage, and/or drive a locking mechanism. In some embodiments, one drive element may correspond to, engage, and/or drive more than one locking mechanism. Other configurations can also be considered.

[0067] Although multiple drive elements and/or corresponding locking mechanisms may be included in the medical implant 16, for the sake of clarity and brevity, much of the following description will be limited to a single case of these elements. Those skilled in the art will readily recognize that the features and operations of the examples described below are equally applicable to all situations of multiple locking mechanisms and/or drive elements.

[0068] In some embodiments, the plurality of locking mechanisms may each include an axially movable post 72, for example, at the junction of the valve leaflet 68 (post 72 may sometimes be referred to as the "engaging post"), and fixed to The anchor member or the receiving portion of the braid 70 (eg, the buckle 76). In other words, in at least some embodiments, the medical implant 16 may include a plurality of posts 72 and a corresponding plurality of receiving portions or buckles 76. Other configurations and correspondences can also be considered. In some embodiments, in the "arranged" configuration, the post 72 may be engaged with the receiving portion or buckle 76. In some embodiments, in the "delivery" configuration, the post 72 may be axially or longitudinally spaced from the receiving portion or buckle 76.

[0069] In some embodiments, the most distal end of the axially movable post 72 may be fixed and/or attached (ie, fixedly attached,

Removably attached, removably attached, etc.) to the distal end of the anchoring member or braid 70, for example using sutures, tethers, adhesives, or other suitable elements. In some embodiments, the post 72 may move axially or longitudinally relative to the anchor member or braid 70 and/or the receiving portion or buckle 76 fixed to the anchor member or braid 70. Other embodiments may be considered in which the receiving portion or buckle 76 may be removably or removably attached to the anchoring member or braid 70. In some embodiments, the post 72 may be fixedly attached to the anchoring member or braid 70 and the receiving portion or buckle 76 may be fixedly attached to the anchoring member or braid 70. In some embodiments, one of the post 72 and the receiving portion or buckle 76 is fixedly attached to the anchoring member or braid 70, and the other is movably or removably attached to the anchoring member or braid 70 . In some embodiments, the post 72 is movably or removably attached to the anchoring member or braid 70, and the receiving portion or buckle 76 is movably or removably attached to the anchoring member or braid 70 . In some embodiments, the post 72 may be fixed or attached (ie, fixedly attached, removably attached, removably attached, etc.) to the distal end of the anchoring member or braid 70. In some embodiments, the receiving portion or buckle 76 may be fixed or attached to the proximal end of the anchoring member or braid 70. In some embodiments, The receiving portion or buckle 76 may be fixed or attached to or attached to the proximal end of the anchoring member or braid 70.

[0070] In some embodiments, the medical implant 16 may include one or more of the plurality of valve leaflets 68 at each respective post 72, adjacent to each respective post 72, and/ Or use (at least partially) each corresponding post 72 to fix to the anchor member or braid 70. The valve leaflets 68 may also be secured to the base or distal end of the anchoring member or braid 70. Located adjacent to (eg, aligned with) the plurality of posts 72 is a corresponding plurality of receiving portions or buckles 76. In the illustrated example, one receiving portion or buckle 76 is attached to the anchoring member or braid 70 adjacent to each of the three posts 72. Therefore, the anchoring member or braid 70 has a total of three receiving portions or buckles 76 and three posts 72 to which the buckles 76 are attached. Similarly, for a total of three driving elements or push-pull rods 84 in the illustrated example, one driving element or push-pull rod 84 is operably connected to each post 72 and the buckle 76. Other embodiments are conceivable in which fewer or more receiving portions or buckles 76, posts 72, and driving elements or push-pull rods 84 may be used. In some embodiments, a seal 74 may be provided around the anchoring member or braid 70, and as the term suggests, may help seal the medical implant 16 at the target implant site or region of interest during deployment. Inside and/or abut the target implantation site or region of interest.

[0071] In some embodiments, the attachment between the medical implant 16 and the inner catheter 14 (and/or the outer sheath 12) may be achieved through the use of a coupler 78. In some embodiments, the coupler 78 may generally include a cylindrical base (not shown) that may be disposed around and/or attached to the inner catheter 14. Protruding distally from the base are a plurality of fingers (for example, two, three, four, etc.) each for engaging with the medical implant 16 at the proximal end of the receiving portion or buckle 76. A collar 80 may be provided around the fingers of the coupler 78 to further assist in holding the fingers and the receiving portion or buckle 76 together, as will be described in more detail below. The guide 82 can be arranged above each finger and at a position proximal to the fixing ring 80, and can be used to keep the fingers of the coupler 78 connected to the driving element or the push-pull rod 84, the push-pull rod 84 extending To be adjacent to the fingers of the coupling 78 (and sliding axially with respect to the fingers of the coupling 78). Finally, the pin release assembly 86 may be a connecting structure in which the retaining post 72, the buckle 76, and the push-pull rod 84 are coupled to each other. In some embodiments, the pin release assembly 86 may include a plurality of individual pins 88 that can be connected together via the coil connector 90 and held to the pin release mandrel 92 with the ferrule 94.

[0072] During delivery, it may be possible by means of the coupling of the fingers of the coupling 78 coupled with the receiving portion or the protruding proximal end of the buckle 76 (and held in place by the fixing ring 80 provided above the coupling) and The medical implant 16 is secured to the distal end of the inner catheter 14 by means of a pin 88 that secures the drive element or push-pull rod 84 and the post 72 together, as will be described below. When the medical implant 16 is advanced to the target site or region of interest, the outer sheath 12 can be withdrawn (eg, moved proximally relative to the inner catheter 14) to expose the medical implant 16. Then, the drive element or push-pull rod 84 can be used to pass proximally

Withdraw the drive element or push-pull rod 84 to pull the post 72 into engagement with the receiving portion or buckle 76, thereby axially shortening and/or radially expanding the medical implant 16 and/or anchoring member or braid 70 and From the "delivery" configuration (for example, shown in Figure 1) "locked" to the expanded or "arranged" configuration (for example, shown in Figure 2). Finally, the pin 88 can be removed, thereby separating the drive element or push-pull rod 84 from the post 72, which allows the drive element or push-pull rod 84 and the fingers of the coupling 78 to be pulled out of the medical implant 16. The medical implant 16 (and/or anchoring member or braid 70) is thus arranged in the anatomical structure in a "released" configuration. In other words, one difference between the "arranged" configuration and the "released" configuration is whether the pin 88 is attached to the post 72. In the "arranged" configuration, the pin 88 is still attached to the post 72, which therefore allows the medical implant 16 (and/or the anchoring member or braid 70) to be unlocked by the distal advancement of the drive element or push-pull rod 84 , As described further below, so as to reposition the medical implant 16 for example. In some embodiments, at least a portion of the plurality of valve leaflets 68 may axially or longitudinally overlap with at least a portion of the receiving portion or buckle 76 at a common location along the longitudinal center axis of the anchoring member or braid 70.

[0073] FIGS. 3-6 show selected components of the locking mechanism used to lock the medical implant 16 (and/or anchoring member or braid 70) in the "arranged" configuration, and the generality of these components operating. For the purpose of simplicity and clarity, only one finger, only one drive element or push-pull rod 84 of the coupling 78, only one post 72, only one receiving portion or buckle 76, only one The fixed ring 80 and only one pin 88 (the entire medical implant 16 and/or the anchoring member or braid 70 are not shown to facilitate the understanding of the locking mechanism). However, it should be understood that the following description is equally applicable to the medical implant 16 (ie, the driving element or push-pull rod 84, the receiving portion or buckle 76, the post 72, the pin 88, etc.) and/or the medical device Any and/or all of the more than one component inside the system 10.

[0074] As seen in FIGS. 2-6, each drive element or push-pull rod 84 extends through the guide 82 adjacent to the finger of the coupling 78, passes through the receiving portion or buckle 76, and enters the longitudinal direction. A channel extending into the proximal end of the hollow shaft portion 96 of the post 72. The drive element or push-pull rod 84 can translate axially past the receiving lock or buckle 76. In some embodiments, the distal end of the drive element or push-pull rod 84 may include a keyed positioning structure for slidably and non-rotatably to cooperate with a channel extending longitudinally into the proximal end of the hollow rod portion 96 of the column 72 .

[0075] The distal end of the drive element or push-pull rod 84 may include a longitudinally oriented elongated orifice or slot (not shown), which may be aligned with the opening 98 through the rod portion 96 of the post 72. When so aligned, the pin 88 can pass through the opening 98 and the elongated orifice or slot of the drive element or push-pull rod 84 to form a loop. This releasably couples the drive element or push-pull rod 84 to the post 72 and forms a configuration that can be adopted during the delivery of the medical implant 16. As can be appreciated, the proximal end of the post 72 and the distal end of the receiving portion or buckle 76 can be separated longitudinally (for example, as seen in FIG. 3), so the medical implant 16 can be adapted to pass through the patient's anatomy percutaneously An elongated and usually low-profile "delivery" configuration that translates to the region of interest and/or target site.

[0076] When the medical implant 16 reaches the desired target site within the anatomical structure, the clinician can retract the drive element or push-pull rod 84 proximally (for example, by using or driving the handle 18 or a portion thereof), thereby Move the proximal end of the rod portion 96 of the post 72 toward the receiving portion or the distal end of the hasp 76 (as seen in FIG. 4, for example) to axially shorten and/or radially expand toward the "arranged" configuration The anchor member or braid 70 of the medical implant 16. When retracting or pulling the drive element or push-pull rod 84 proximally, the pin 88 positioned through the opening 98 in the post 72 is provided through the distal end of the elongated orifice or slot. Finally, the drive element or push-pull rod 84 can be fully retracted, far enough to use the receiving portion or buckle 76 to lock the post 72, thereby locking the medical implant 16 in an "arrangement" suitable for implantation into the anatomical structure. "Configuration (for example, as seen in Figures 4 and 5). In other words, in some embodiments, the axial translation of the drive element or push-pull rod 84 (and the post 72 connected to it) in the proximal direction relative to the receiving portion or the buckle 76 can shift the anchoring member or braid 70 is driven from the "delivery" configuration to the "arrangement" configuration.

[0077] FIG. 4 shows the drive element or push-pull rod 84 being retracted proximally, which causes the proximal end of the rod portion 96 of the post 72 to be pulled into contact with the receiving portion or the distal end of the buckle 76. At this point, the rod 96 is pulled into the receiving portion or the distal end of the buckle 76. In at least some embodiments, the rod portion 96 is slidably and non-rotatably received inside the receiving portion or buckle 76.

[0078] In the process of pulling the rod 96 into the receiving portion or buckle 76, the raised generally transversely oriented shoulder or ridge 100 provided on the proximal end of the rod 96 of the post 72 will be proximally It is pulled into the receiving portion or buckle 76 until the raised generally transversely oriented shoulder or ridge 100 is pulled past the receiving portion or buckle 76. In this configuration, the receiving portion or buckle 76 is engaged with the raised generally transversely oriented shoulder or spine 100 and the post 72 can be fixed to the receiving portion or buckle 76, thereby preventing the post 72 from being relative to the receiving The distal movement of the buckle or buckle 76 is, for example, under rebound stress from the anchoring member or braid 70.

[0079] However, at this time, the drive element or push-pull rod 84 can be pushed distally to "unlock" the medical implant 16, thereby allowing the repositioning and/or withdrawal of the medical implant 16. When the driving element or the push-pull rod 84 is pushed distally, the driving element or the push-pull rod 84 can be translated distally relative to the locking mechanism (ie, the post 72 and/or the receiving portion or the buckle 76), so as to extend through The pin 88 of the opening 98 is positioned at the proximal end of the elongated orifice or slot. Once the pin 88 is positioned at the proximal end of the elongated orifice or slot, the post 72 can be moved distally relative to the receiving portion or buckle 76 together with the drive element or push-pull rod 84.

[0080] The longitudinally oriented ridge 102 on the distal end of the drive element or push-pull rod 84, alone or as part of a keyed positioning structure, may be included for when the drive element or push-pull rod 84 travels distally A distally inclined surface that engages with the receiving portion or buckle 76. Therefore, the receiving portion or buckle 76 can slide on the inclined surface of the longitudinally oriented ridge 102, thereby allowing the generally transversely oriented ridge 100 on the stem portion 96 of the post 72 to be separated from the receiving portion or buckle 76 and facing Distal translation. In other words, the distal axial translation of the drive element or push-pull rod 84 unlocks the anchoring member or braid 70 from the "arranged" configuration.

[0081] Since the pin 88 is positioned at the proximal end of the elongated orifice or slot, further distal advancement of the drive element or push-pull rod 84 will no longer cause the drive element or push-pull rod 84 to be relative to the locking mechanism as a whole Translation. Conversely, further distal advancement of the drive element or push-pull rod 84 (ie, distal axial translation) will result in the use of a pin 88 to connect the drive element or push-pull rod 84 to the post 72, relative to the receiving portion or buckle. 76 translates distally, thereby driving the anchoring member or braid 70 from the "deployed" configuration to the "delivered" configuration.

[0082] Alternatively, if the clinician is satisfied with the positioning and/or locking of the medical implant 16 (e.g., after visualization of the medical implant 16 using a suitable imaging technique), the pin 88 can be pulled (e.g., Removed from the opening 98 and elongated aperture or slot at the distal end of the drive element or push-pull rod 84) in order to separate and/or separate the drive element or push-pull rod 84 from the post 72, thereby allowing for example the drive element or push-pull rod 84 to be separated and/or separated The pull rod 84 is retracted proximally from the post 72, as seen in FIG. 5.

[0083] Further withdrawal of the drive element or push-pull rod 84 may cause the longitudinally oriented ridge 102 on the distal end of the drive element or push-pull rod 84 to engage with the collar 80, and cause when the drive element or push-pull rod 84 is facing When retracting proximally, the collar 80 slides proximally along the fingers of the coupler 78. In this case, the fork end 104 of the finger of the coupling 78 having the groove 106 formed therein is exposed and can be separated from the rail 108 on the proximal end of the receiving portion or the buckle 76. The track 108 has a protrusion 110 formed thereon for mating engagement with the groove 106, as shown in FIG. 5. After the fork end 104 has been separated from the track 108, further proximal withdrawal of the at least one drive element or push-pull rod 84 causes the fingers of the coupling 78 to withdraw proximally from the locking mechanism and the medical implant 16, As seen in Fig. 6, for example, the medical implant 16 in the "released" configuration is thus left at the target site.

[0084] FIGS. 7 and 8 show the selections associated with the medical implant 16 of the medical device system 10 as described above when the medical implant is in the "delivery" configuration and the "arrangement" configuration, respectively part. As seen in Figure 7 and similar to the description above

As mentioned, the locking mechanism may include an axially movable post 72 and a receiving portion or buckle 76. An element of the delivery device, such as a drive element or push-pull rod 84, may be translatably arranged to pass through the receiving portion or buckle 76 and releasably engage and/or attach to the post 72. In some embodiments, the distal end of the drive element or push-pull rod 84 may include a socket keying orientation for slidably and/or matingly engaged with a corresponding channel extending into the proximal end of the rod portion 96 of the post 72 structure. In at least some embodiments, the sleeve keying orientation structure and/or the channel extending into the proximal end of the rod 96 can prevent relative rotation between the drive element or push-pull rod 84 and the post 72.

[0085] In some embodiments, the distal end of the socket keying orientation structure may be substantially flattened into a generally transversely oriented cross-section extending along most of the socket keying orientation structure. The distal portion of the channel extending into the proximal end of the stem portion 96 may be in the shape of a groove to correspond to and slidably receive the flattened, generally transversely oriented cross-section of the socket keying orientation structure therein. In some embodiments, the proximal end of the socket keying orientation structure may be substantially T-shaped and/or may include a longitudinally oriented ridge 102 that is disposed substantially perpendicular to the distal end of the socket keying orientation structure The flattened generally transversely oriented cross section of the part. The proximal end of the channel extending into the rod portion 96 may include a corresponding T shape for a socket keyed orientation structure for slidably receiving therein the driving element of the push-pull rod 84.

[0086] At a position adjacent to the distal end of the channel extending into the rod portion 96, the opening 98 may pass through the distal portion rod portion 96 substantially perpendicular to the sleeve keying orientation structure, so that the opening 98 is connected to the driving element or the pushing element. The elongated orifice or slot at the distal end of the tie rod 84 is aligned. The pin 88 may extend through the opening 98 and the elongated aperture or slot at the distal end of the drive element or push-pull rod 84 to couple the drive element or push-pull rod 84 to the post 72.

[0087] In at least some embodiments, the post 72 may include a distally extending body portion 120 that extends distally from the stem portion 96 toward the distal end of the anchoring member or braid 70. In some embodiments, the main body 120 and the rod 96 may be integral, and/or integrally formed as a single piece of material, and/or formed from a single piece of material. In some embodiments, the main body 120 and the rod 96 may be composed of a single piece of wire, round stock, or other suitable materials. In some embodiments, the stem 96 may be substantially polygonal (ie, two-sided, three-sided, four-sided, five-sided, six-sided, etc.) shape. Other shapes (regular and irregular) are also conceivable. In some embodiments, the rod portion 96 may be formed by further processing a single piece of wire, round stock, or other suitable materials (for example, by machining, stamping, laser cutting, etc.). In some embodiments, the lever 96 is prevented from rotating relative to the receiving portion or buckle 76 (ie, being non-rotatable) when the lever 96 is engaged with the receiving portion or buckle 76.

[0088] In some embodiments, the distal end of the post 72 may include a flexible butt 122. In some embodiments, the mating portion 122 connects the body portion 120 to the leg portion 124 that extends radially inward from the body portion 120 of the post 72 (relative to the anchoring member or braid 70). In some embodiments, the leg portion 124 may protrude from the mating portion 122 and/or the main body portion 120 in a cantilevered manner. In some embodiments, the connecting portion 122 may be an extension portion of the main body portion 120, which is at least partially bent back onto itself and transitions into the leg portion 124. In some embodiments, the abutment portion 122 may have and/or include a radius of curvature. For example, in some embodiments, the radius of curvature may be between 0 and 3 millimeters (mm). In some embodiments, the connecting portion 122 can be used to set the main body 120 and the leg portion 124 at an acute angle relative to each other. In some embodiments, the acute angle may be between about 0 degrees and about 90 degrees, between about 3 degrees and about 60 degrees, between about 5 degrees and about 45 degrees, between about 8 degrees and about 30 degrees, between about Between about 10 degrees and about 20 degrees, between about 12 degrees and about 16 degrees, about 14 degrees, or another suitable angle. In at least some embodiments, the docking portion 122 flexibly attaches the leg portion 124 to the main body portion 120 of the post 72. In some embodiments, the legs 124 can be removed from the main The body 120 extends toward the proximal end of the anchoring member or braid 70. In some embodiments, the leg portion 124 may be attached to the main body portion 120 of the post 72 at the distal end of the main body portion 120 of the post 72. In some embodiments, at least a portion of the leg portion 124 may longitudinally overlap the receiving portion or buckle 76 along the longitudinal center axis of the anchoring member or braid 70 in the "arranged" configuration.

[0089] In some embodiments, the leg 124 may include a free end 126 and a fixed end, wherein the leg 124 may be at the fixed end

Attached to the main body portion 120 of the post 72, the fixed end can be directly connected to the connecting portion 122. In some embodiments, the free end 126 of the leg 124 may not be attached (ie, not directly attached) to any other structure of the medical implant 16 except for the leg 124 and/or the plurality of valve leaflets 68. In other words, in some embodiments, the free end 126 may not be directly attached to any other structure or feature of the medical implant 16 (ie, the receiving portion or buckle 76, the anchoring member or braid 70, etc.) . In some embodiments, the most distal end of the post 72 (at least in some embodiments it may be and/or include the money link 122) may be coupled to the distal end of the anchor member or braid 70, for example by a coupling member such as suture Thread, filament, silk, or other suitable tools. Therefore, when the post 72 is pulled proximally to engage the receiving portion or buckle 76, the distal end of the anchoring member or braid 70 is also pulled proximally relative to the receiving portion or buckle 76, thereby from "transporting" The configuration changes to the "arrangement" configuration.

[0090] In at least some embodiments, one or more of the plurality of valve leaflets 68 may be attached to the leg 124. In some embodiments, multiple valve leaflets 68 may be fixed directly to the leg 124. In some embodiments, the plurality of valve leaflets 68 may not be directly fixed to the main body portion 120 and/or the stem portion 96 of the post 72, but are coupled to the post 72 via the legs 124. In some embodiments, multiple valve leaflets 68 may wrap around the leg 124. In some embodiments, the most distal end of the plurality of valve leaflets may be coupled to the distal end of the anchoring member or braid 70. In some embodiments, one or more sutures, threads, threads, filaments, or other suitable elements may be used to couple and/or fix the multiple valve leaflets 68 (ie, to the leg 124, anchor member, or braid 70, and/or back to themselves). In some embodiments, a plurality of valve leaflets 68 may be connected and/or fixed (ie, to the leg 124, anchor member or braid 70, and/or to the leg 124, anchor member or braid 70, Back to themselves). In some embodiments, fabrics, textiles, or other thin flexible materials may be used to couple and/or fix multiple valve leaflets 68 (ie, to the legs 124, to the anchoring member or braid 70, and/or to the Back to themselves).

[0091] FIGS. 9 and 10 show the selections associated with the medical implant 16 of the medical device system 10 as described above when the medical implant is in the "delivery" configuration and the "arrangement" configuration, respectively part. As can be seen in FIG. 7 and similar to the description above, the locking mechanism may include an axially movable post 72 and a receiving portion or buckle 76. An element of the delivery device, such as a drive element or push-pull rod 84, may be translatably arranged to pass through the receiving portion or buckle 76 and releasably engage and/or attach to the post 72. In some embodiments, the distal end of the drive element or push-pull rod 84 may include a socket keying orientation for slidably and/or matingly engaged with a corresponding channel extending into the proximal end of the rod portion 96 of the post 72 structure. In at least some embodiments, the sleeve keying orientation structure and/or the channel extending into the proximal end of the rod 96 can prevent relative rotation between the drive element or push-pull rod 84 and the post 72.

[0092] In some embodiments, the distal end of the socket keying orientation structure may be substantially flattened into a generally transversely oriented cross-section extending along most of the socket keying orientation structure. The distal portion of the channel extending into the proximal end of the stem portion 96 may be in the shape of a groove to correspond to and slidably receive the flattened, generally transversely oriented cross-section of the socket keying orientation structure therein. In some embodiments, the proximal end of the socket keying orientation structure may be substantially T-shaped and/or may include a longitudinally oriented ridge 102 that is disposed substantially perpendicular to the distal end of the socket keying orientation structure The flattened generally transversely oriented cross section of the part. The proximal end of the channel extending into the rod portion 96 may include a corresponding T shape for a socket keyed orientation structure for slidably receiving therein the driving element of the push-pull rod 84.

[0093] At a position adjacent to the distal end of the channel extending into the shaft portion 96, the opening 98 may pass through the distal portion shaft portion 96 substantially perpendicular to the sleeve keying orientation structure, so that the opening 98 is connected to the drive element or pusher. The elongated orifice or slot at the distal end of the tie rod 84 is aligned. The pin 88 may extend through the opening 98 and the elongated aperture or slot at the distal end of the drive element or push-pull rod 84 to couple the drive element or push-pull rod 84 to the post 72.

[0094] In at least some embodiments, the post 72 may include a distally extending body portion 120 that extends distally from the stem portion 96 toward the distal end of the anchoring member or braid 70. In some embodiments, the main body 120 and the rod 96 may be

Integral, and/or integrally formed as a single piece of material, and/or formed from a single piece of material. In some embodiments, the main body 120 and the rod 96 may be composed of a single piece of wire, round stock, or other suitable materials. In some embodiments, the stem 96 may be substantially polygonal (ie, two-sided, three-sided, four-sided, five-sided, six-sided, etc.) shape. Other shapes (regular and irregular) are also conceivable. In some embodiments, the rod portion 96 may be formed by further processing a single piece of wire, round stock, or other suitable materials (for example, by machining, stamping, laser cutting, etc.). In some embodiments, the lever 96 is prevented from rotating relative to the receiving portion or buckle 76 (ie, being non-rotatable) when the lever 96 is engaged with the receiving portion or buckle 76.

[0095] In some embodiments, the distal end of the post 72 may include a flexible mating portion 122. In some embodiments, the mating portion 122 connects the body portion 120 to the leg portion 124 that extends radially inward from the body portion 120 of the post 72 (relative to the anchoring member or braid 70). In some embodiments, the leg portion 124 may protrude from the mating portion 122 and/or the main body portion 120 in a cantilevered manner. In some embodiments, the connecting portion 122 may be an extension portion of the main body portion 120, which is at least partially bent back onto itself and transitions into the leg portion 124. In some embodiments, the abutment portion 122 may have and/or include a radius of curvature. For example, in some embodiments, the radius of curvature may be between 0 and 3 millimeters (mm). In some embodiments, the connecting portion 122 can be used to set the main body 120 and the leg portion 124 at an acute angle relative to each other. In some embodiments, the acute angle may be between about 0 degrees and about 90 degrees, between about 3 degrees and about 60 degrees, between about 5 degrees and about 45 degrees, between about 8 degrees and about 30 degrees, between about Between about 10 degrees and about 20 degrees, between about 12 degrees and about 16 degrees, about 14 degrees, or another suitable angle. In at least some embodiments, the docking portion 122 movably attaches the leg portion 124 to the main body portion 120 of the post 72. In some embodiments, the legs 124 can be removed from the main body of the post 72 The portion 120 extends toward the proximal end of the anchoring member or braid 70. In some embodiments, the leg portion 124 may be attached to the main body portion 120 of the post 72 at the distal end of the main body portion 120 of the post 72. In some embodiments, at least a portion of the leg portion 124 may longitudinally overlap the receiving portion or buckle 76 along the longitudinal center axis of the anchoring member or braid 70 in the "arranged" configuration.

[0096] In some embodiments, the leg portion 124 may include a free end 126 and a fixed end, where the leg portion 124 may be attached to the main body portion 120 of the column 72 at the fixed end, and the fixed end may be directly connected to the connecting portion 122. In some embodiments, the free end 126 of the leg 124 may not be attached (ie, not directly attached) to any other structure of the medical implant 16 except for the leg 124 and/or the plurality of valve leaflets 68. In other words, in some embodiments, the free end 126 may not be directly attached to any other structure or feature of the medical implant 16 (ie, the receiving portion or buckle 76, the anchoring member or braid 70, etc.) . In some embodiments, the most distal end of the post 72 (at least in some embodiments it may be and/or include the butt portion 122) may be coupled to the distal end of the anchor member or braid 70, for example by a coupling member such as suture Thread, filament, silk, or other suitable tools. Therefore, when the post 72 is pulled proximally to engage the receiving portion or buckle 76, the distal end of the anchoring member or braid 70 is also pulled proximally relative to the receiving portion or buckle 76, thereby from "transporting" The configuration changes toward the "arrangement" configuration.

[0097] In at least some embodiments, one or more of the plurality of valve leaflets 68 may be attached to the leg 124. In some embodiments, multiple valve leaflets 68 may be fixed directly to the leg 124. In some embodiments, the plurality of valve leaflets 68 may not be directly fixed to the main body portion 120 and/or the stem portion 96 of the post 72, but are coupled to the post 72 via the legs 124. In some embodiments, multiple valve leaflets 68 may wrap around the leg 124. In some embodiments, the most distal end of the plurality of valve leaflets may be coupled to the distal end of the anchoring member or braid 70. In some embodiments, one or more sutures, threads, threads, filaments, or other suitable elements may be used to couple and/or fix the multiple valve leaflets 68 (ie, to the leg 124, anchor member, or braid 70, and/or back to themselves). In some embodiments, a plurality of valve leaflets 68 may be connected and/or fixed (ie, to the leg 124, anchor member or braid 70, and/or to the leg portion 124, anchor member or braid 70, and/or to the leg portion 124, the anchor member or the braid 70, etc.) using adhesives, adhesives, or other suitable fixing means. Back to themselves). In some embodiments, fabrics, textiles, or other thin flexible materials may be used to couple and/or fix multiple valve leaflets 68 (ie, to the legs 124, to the anchoring member or braid 70, and/or to the Back to themselves).

[0098] FIGS. 11 and 12 show the difference between the medical implants when they are in the "delivery" configuration and the "arrangement" configuration, respectively.

The selected components associated with the medical implant 16 of the medical device system 10 described above. As can be seen in FIG. 7 and similar to the description above, the locking mechanism may include an axially movable post 72 and a receiving portion or buckle 76. An element of the delivery device, such as a drive element or push-pull rod 84, may be translatably arranged to pass through the receiving portion or buckle 76 and releasably engage and/or attach to the post 72. In some embodiments, the distal end of the drive element or push-pull rod 84 may include a socket keying orientation for slidably and/or matingly engaged with a corresponding channel extending into the proximal end of the rod portion 96 of the post 72 structure. In at least some embodiments, the sleeve keying orientation structure and/or the channel extending into the proximal end of the rod 96 can prevent relative rotation between the drive element or push-pull rod 84 and the post 72.

[0099] In some embodiments, the distal end of the socket keying orientation structure may be substantially flattened into a generally transversely oriented cross-section extending along most of the socket keying orientation structure. The distal portion of the channel extending into the proximal end of the stem portion 96 may be in the shape of a groove to correspond to and slidably receive the flattened, generally transversely oriented cross-section of the socket keying orientation structure therein. In some embodiments, the proximal end of the socket keying orientation structure may be substantially T-shaped and/or may include a longitudinally oriented ridge 102 that is disposed substantially perpendicular to the distal end of the socket keying orientation structure The flattened generally transversely oriented cross section of the part. The proximal end of the channel extending into the rod portion 96 may include a corresponding T shape for a socket keyed orientation structure for slidably receiving therein the driving element of the push-pull rod 84.

[0100] At a position adjacent to the distal end of the channel extending into the rod portion 96, the opening 98 may pass through the distal portion rod portion 96 substantially perpendicular to the sleeve keying orientation structure, so that the opening 98 is connected to the driving element or the pushing element. The elongated orifice or slot at the distal end of the tie rod 84 is aligned. The pin 88 may extend through the opening 98 and the elongated aperture or slot at the distal end of the drive element or push-pull rod 84 to couple the drive element or push-pull rod 84 to the post 72.

[0101] In at least some embodiments, the post 72 may include a distally extending body portion 120 that extends distally from the stem portion 96 toward the distal end of the anchor member or braid 70. In some embodiments, the post 72 may include a plurality of body portions 120 extending distally from the shaft portion 96 toward the distal end of the anchoring member or braid 70. In some embodiments, the plurality of body parts 120 may include two body parts 120, three body parts 120, four body parts 120, or other suitable number of body parts 120. In some embodiments, the main body 120 and the rod 96 may be integral, and/or integrally formed as a single piece of material, and/or formed from a single piece of material. In some embodiments, the main body 120 may be formed separately from the rod 96 and fixedly attached to the rod 96. In some embodiments, the plurality of body parts 120 may be composed of a single piece of wire, round stock, or other suitable materials. In some embodiments, the stem portion 96 may include one or more holes or apertures for receiving and/or securing the proximal end of the body portion 120 therein. In some embodiments, one or more holes or orifices may be oriented generally transversely with respect to the stem 96. In some embodiments, the stem 96 may have a substantially polygonal (ie, two-sided, three-sided, four-sided, five-sided, six-sided, etc.) shape. Other shapes (regular and irregular) are also conceivable. In some embodiments, it can be prevented that when the rod portion 96 is engaged with the receiving portion or the buckle 76 The rotation of the hour lever portion 96 relative to the receiving portion or the buckle 76 (ie, is not rotatable).

[0102] In some embodiments, the distal end of the post 72 may include a flexible abutment 122. In some embodiments, the distal end of the post 72 may include a plurality of abutment portions 122 corresponding to and/or fixedly attached to the plurality of body portions 120. In some embodiments, the plurality of mating parts 122 may include two mating parts 122, three mating parts 122, four mating parts 122, or other suitable number of mating parts 122. In some embodiments, the mating portion 122 connects the main body portion 120 to the leg portion 124 or multiple legs 124 extending radially inward from the main body portion 120 of the post 72 (relative to the anchoring member or braid 70). In some embodiments, the leg portion 124 may overhang from the mating portion 122 and/or the main body portion 120. In some embodiments, the plurality of legs 124 may include two legs 124, three legs 124, four legs 124, or another suitable number of legs 124. In some embodiments, the mating portion 122 may be an extension portion of the main body portion 120 that is at least partially bent back onto itself and transitions into the leg portion 124. In some embodiments, the mating portion 122 may have and/or include a radius of curvature. For example, in some embodiments, the radius of curvature

It can be between 0 and 3 millimeters (mm). In some embodiments, the mating portion 122 can be used to set the main body 120 and the leg portion 124 at an acute angle with respect to each other. In some embodiments, the acute angle may be between about 0 degrees and about 90 degrees, between about 3 degrees and about 60 degrees, between about 5 degrees and about 45 degrees, between about 8 degrees and about 30 degrees, Between about 10 degrees and about 20 degrees, between about 12 degrees and about 16 degrees, about 14 degrees, or another suitable angle. In at least some embodiments, the docking portion 122 flexibly attaches the leg portion 124 to the main body portion 120 of the post 72. In some embodiments, the leg portion 124 may extend from the main body portion 120 of the post 72 toward the proximal end of the anchoring member or braid 70. In some embodiments, the leg portion 124 may be attached to the main body portion 120 of the post 72 at the distal end of the main body portion 120 of the post 72. In some embodiments, when in the "arranged" configuration, at least a portion of the leg portion 124 longitudinally overlaps the receiving portion or buckle 76 along the longitudinal center axis of the anchoring member or braid 70.

[0103] In some embodiments, the leg portion 124 may include a free end 126 and a fixed end, wherein the leg portion 124 may be attached to the main body portion 120 of the post 72 at the fixed end that can be directly connected to the mating portion 122. In some embodiments, multiple legs 124 may be connected together at the free end 126. In some embodiments, the plurality of legs 124 may be arranged substantially parallel to each other. In some embodiments, the free end 126 of the leg 124 may not be attached (ie, not directly attached) to any other structure of the medical implant 16 except for the leg 124 and/or the plurality of valve leaflets 68. In other words, in some embodiments, the free end 126 may not be directly attached to any other structure or feature of the medical implant 16 (ie, the receiving portion or buckle 76, the anchoring member or braid 70, etc.). In some embodiments, the most distal end of the post 72 (at least in some embodiments may be and/or include the butt portion 122) may be coupled to the distal end of the anchor member or braid 70, for example by a coupling member, suture , Filament, silk, or other suitable tools. Therefore, when the post 72 is pulled proximally to engage the receiving portion or buckle 76, the distal end of the anchoring member or braid 70 is also pulled proximally relative to the receiving portion or buckle 76, thereby moving from the "transporting" structure. The model changes to the "arrangement" configuration.

[0104] In at least some embodiments, one or more of the plurality of valve leaflets 68 may be attached to the leg 124. In some embodiments, at least some of the plurality of valve leaflets 68 may extend and/or pass between the plurality of legs 124. In some embodiments, at least some of the plurality of valve leaflets 68 may extend and/or pass between two adjacent legs 124. In some embodiments, multiple valve leaflets 68 may be directly secured to the leg 124. In some embodiments, the plurality of valve leaflets 68 may not be directly fixed to the main body portion 120 and/or the stem portion 96 of the post 72, but are coupled to the post 72 via the legs 124. In some embodiments, multiple valve leaflets 68 may wrap around the leg 124. In some embodiments, the at least some of the plurality of valve leaflets 68 extending between and/or passing through two adjacent legs 124 may be wrapped around two adjacent legs 124. In some embodiments, the most distal end of the plurality of valve leaflets 68 may be coupled to the distal end of the anchoring member or braid 70. In some embodiments, one or more sutures, threads, wires, filaments, or other suitable elements may be used to couple and/or fix multiple valve leaflets 68 (ie, to the leg 124, to the anchoring member or Braid 70, and/or back to themselves). In some embodiments, a plurality of valve leaflets 68 can be connected and/or connected by using adhesives, adhesives, or other suitable fixing means. Fixed (ie, to the leg 124, to the anchoring member or braid 70, and/or back to themselves). In some embodiments, fabrics, textiles, or other thin flexible materials may be used to couple and/or fix multiple valve leaflets 68 (ie, to the leg 124, anchoring member or braid 70, and/or rearwardly To themselves).

[0105] FIGS. 13 and 14 show the selections associated with the medical implant 16 of the medical device system 10 as described below when the medical implant is in the "delivery" configuration and the "arrangement" configuration, respectively part. As can be seen in FIG. 13 and similar to the description above, the locking mechanism may include an axially movable post 72 and a receiving portion or buckle 76. One element of the delivery device (for example, a drive element or push-pull rod 84) may be provided translatably past the receiving portion or buckle 76 and removably engage and/or attach to the post 72. In some embodiments, the distal end portion of the drive element or push-pull rod 84 may include a socket keying orientation structure for slidably and/or matingly engaged with a corresponding channel extending into the proximal end of the rod portion 96 of the post 72 . In at least some embodiments, the sleeve keying orientation structure and/or channel extending into the proximal end of the stem 96 can prevent the drive element or push

The relative rotation between the tie rod 84 and the column 72.

[0106] In some embodiments, the distal end of the socket keying orientation structure may be substantially flattened into a generally transversely oriented cross-section extending along most of the socket keying orientation structure. The distal portion of the channel extending into the proximal end of the stem portion 96 may be in the shape of a groove, so as to correspond to and slidably receive therein the flattened, generally transversely oriented cross-section of the socket keying orientation structure. In some embodiments, the proximal end of the socket keying orientation structure may be substantially T-shaped, and/or may include a flattened, generally transverse orientation substantially perpendicular to the distal end of the socket keying orientation structure The longitudinally oriented ridge 102 is arranged in a cross-sectional manner. The proximal end of the channel extending into the rod portion 96 may include a corresponding T-shape of a socket keyed orientation structure for slidably receiving therein the driving element of the push-pull rod 84.

[0107] At a position adjacent to the distal end of the channel extending into the rod portion 96, the opening 98 can pass through the rod portion 96 that is substantially perpendicular to the distal end of the socket keying orientation structure, so that the opening 98 is in the drive element Or the distal end of the push-pull rod 84 is aligned with the elongated orifice or slot. The pin 88 may extend through the opening 98 and the elongated aperture or slot at the distal end of the drive element or push-pull rod 84 to couple the drive element or push-pull rod 84 to the post 72.

[0108] In at least some embodiments, the post 72 may include a distally extending body portion 120 that extends distally from the stem portion 96 toward the distal end of the anchor member or braid 70. In some embodiments, the post 72 may include a plurality of body portions 120 extending distally from the shaft portion 96 toward the distal end of the anchoring member or braid 70. In some embodiments, the plurality of body parts 120 may include two body parts 120, three body parts 120, four body parts 120, or other suitable number of body parts 120. In some embodiments, the main body 120 may be integral with the stem 96 and/or be in the form of a single piece of material and/or be formed integrally with the stem 96 from a single piece of material. In some embodiments, the main body 120 may be separated from the rod 96 and fixedly attached to the rod 96. In some embodiments, the plurality of body parts 120 may be composed of a single piece of wire, round stock, or other suitable materials. In some embodiments, the stem portion 96 may include one or more holes or apertures for receiving and/or securing the proximal end of the body portion 120 therein. In some embodiments, one or more holes or orifices may be oriented generally longitudinally relative to the stem 96. In some embodiments, a laterally oriented channel may extend through the stem 96 and intersect one or more holes or openings. In some embodiments, the pin may be provided inside a transversely oriented channel and may be received in one or more holes or openings. The groove or notch at the proximal end of the main body portion 120 of the part engages, thereby fixing the main body part 120 to the rod part 96. In some embodiments, the stem 96 may have a substantially polygonal (ie, two-sided, three-sided, four-sided, five-sided, six-sided, etc.) shape. Other shapes (regular and irregular) are also conceivable. In some embodiments, rotation (ie, non-rotatable) of the lever 96 relative to the receiving portion or the hasp 76 when the lever 96 is engaged with the receiving portion or the hasp 76 may be prevented.

[0109] In some embodiments, the distal end of the post 72 may include a flexible abutment 122. In some embodiments, the distal end of the post 72 may include a plurality of abutment portions 122 corresponding to and/or fixedly attached to the plurality of body portions 120. In some embodiments, the plurality of mating parts 122 may include two mating parts 122, three mating parts 122, four mating parts 122, or other suitable number of mating parts 122. In some embodiments, the mating portion 122 connects the main body portion 120 to a leg portion 124 or a plurality of legs 124 extending radially inward from the main body portion 120 of the post 72 (relative to the anchoring member or braid 70) . In some embodiments, the leg portion 124 may protrude outward from the mating portion 122 and/or the main body portion 120. In some embodiments, the plurality of legs 124 may include two legs 124, three legs 124, four legs 124, or another suitable number of legs 124. In some embodiments, the mating portion 122 may be an extension portion that is at least partially bent back onto itself and transitions into the main body portion 120 of the leg portion 124. In some embodiments, the abutment portion 122 may have and/or include a radius of curvature. For example, in some embodiments, the radius of curvature may be between 0 and 3 millimeters (mm). In some embodiments, the connecting portion 122 can be used to set sharp angles relative to each other. The main body 120 and the leg 124 are provided. In some embodiments, the acute angle may be between about 0 degrees and about 90 degrees, between about 3 degrees and about 60 degrees, between about 5 degrees and about 45 degrees, between about 8 degrees and about 30 degrees, between about Between 10 degrees and about 20 degrees, at about 12 degrees

And about 16 degrees, about 14 degrees, or other suitable angles. In at least some embodiments, the docking portion 122 flexibly attaches the leg portion 124 to the main body portion 120 of the post 72. In some embodiments, the leg portion 124 may extend from the main body portion 120 of the post 72 toward the proximal end of the anchoring member or braid 70. In some embodiments, the leg portion 124 may be attached to the main body portion 120 of the post 72 at the distal end of the main body portion 120 of the post 72. In some embodiments, at least a portion of the leg portion 124 may longitudinally overlap the receiving portion or buckle 76 along the longitudinal center axis of the anchoring member or braid 70 in the "arranged" configuration.

[0110] In some embodiments, the leg portion 124 may include a free end 126 and a fixed end, wherein the leg portion 124 may be attached to the main body portion 120 of the post 72 at the fixed end that can be directly connected to the mating portion 122. In some embodiments, multiple legs 124 may be connected together at the free end 126. In some embodiments, the plurality of legs 124 may be arranged substantially parallel to each other. In some embodiments, the free end 126 of the leg 124 may not be attached (ie, not directly attached) to any other structure of the medical implant 16 except for the leg 124 and/or the plurality of valve leaflets 68. In other words, in some embodiments, the free end 126 may not be directly attached to any other structure or feature of the medical implant 16 (ie, the receiving portion or buckle 76, the anchoring member or braid 70, etc.) . In some embodiments, the most distal end of the post 72 (at least in some embodiments may be and/or include the butting portion 122) can be coupled to the distal end of the anchor member or braid 70, for example, using a coupling member (such as a suture). Thread, filament, silk, or other suitable means). Therefore, when the post 72 is pulled proximally to engage the receiving portion or buckle 76, the distal end of the anchoring member or braid 70 is also pulled proximally relative to the receiving portion or buckle 76, thereby removing The configuration changes to the "arrangement" configuration.

[0111] In at least some embodiments, one or more of the plurality of valve leaflets 68 may be attached to the leg 124. In some embodiments, at least part of the plurality of valve leaflets 68 may extend and/or pass between the plurality of legs 124. In some embodiments, at least part of the plurality of valve leaflets 68 may extend and/or pass between two adjacent legs 124. In some embodiments, multiple valve leaflets 68 may be directly secured to the leg 124. In some embodiments, the plurality of valve leaflets 68 may not be directly fixed to the main body portion 120 and/or the stem portion 96 of the post 72, but are coupled to the post 72 via the legs 124. In some embodiments, multiple valve leaflets 68 may wrap around the leg 124. In some embodiments, at least part of a plurality of valve leaflets 68 extending between and/or passing through two adjacent legs 124 may be wrapped around two adjacent legs 124. In some embodiments, the most distal end of the plurality of valve leaflets 68 may be coupled to the distal end of the anchoring member or braid 70. In some embodiments, one or more sutures, threads, wires, filaments, or other suitable elements may be used to couple and/or fix multiple valve leaflets 68 (ie, to the leg 124, to the anchoring member, or Braid 70, and/or back to themselves). In some embodiments, adhesives, adhesives, or other suitable fixing means may be used to couple and/or fix the multiple valve leaflets 68 (ie, to the leg Section 124, to the anchoring member or braid 70, and/or back to themselves). In some embodiments, fabrics, textiles, or other thin flexible materials may be used to couple and/or fix multiple valve leaflets 68 (ie, to the legs 124, to the anchoring member or braid 70, and/or to the Back to themselves).

[0112] FIGS. 15 and 16 show selections associated with the medical implant 16 of the medical device system 10 as described above when the medical implant is in the "delivery" configuration and the "arrangement" configuration, respectively As seen in Figure 15 and similar to the above description, the locking mechanism may include an axially movable post 72 and a receiving portion or buckle 76. An element of the conveying device (such as a driving element or a push-pull rod 84) may be Translatingly arranged to pass through the receiving portion or buckle 76 and releasably engage and/or attach to the post 72. In some embodiments, the distal end of the drive element or push-pull rod 84 may include A socket keying orienting structure that slidably and/or matingly engages a corresponding channel extending into the proximal end of the shaft portion 96 of the post 72. In at least some embodiments, the socket keying orienting structure and/or extend into the shaft The keyed channel at the proximal end of 96 prevents relative rotation between the drive element or push-pull rod 84 and the post 72.

[0113] In some embodiments, the distal end of the socket keying orientation structure may be substantially flattened to be keyed along most of the socket

A generally transversely oriented cross-section extending from the oriented structure. The distal portion of the channel extending into the proximal end of the stem portion 96 may be in the shape of a groove, so as to correspond to and slidably receive the flattened, generally transversely oriented cross-section of the socket keying orientation structure therein. In some embodiments, the proximal end of the socket keying orientation structure may be substantially T-shaped, and/or may include a flattened, generally transversely oriented cross-section substantially perpendicular to the distal end of the socket keying orientation structure. The longitudinally oriented ridges 102 are arranged in a manner. The proximal end of the channel extending into the rod portion 96 may include a corresponding T shape for a socket keyed orientation structure for slidably receiving therein the driving element of the push-pull rod 84.

[0114] At a position adjacent to the distal end of the channel extending into the stem portion 96, the opening 98 may pass through the stem portion 96 substantially perpendicular to the distal end of the socket keying orientation structure, so that the opening 98 is in the drive element Or the distal end of the push-pull rod 84 is aligned with the elongated orifice or slot. The pin 88 may extend through the opening 98 and the elongated aperture or slot at the distal end of the drive element or push-pull rod 84 in order to couple the drive element or push-pull rod 84 to the post 72.

[0115] In at least some embodiments, the post 72 may include a distally extending body portion 120 that extends distally from the stem portion 96 toward the distal end of the anchor member or braid 70. In some embodiments, the post 72 may include a plurality of body portions 120 extending distally from the shaft portion 96 toward the distal end of the anchoring member or braid 70. In some embodiments, the plurality of body parts 120 may include two body parts 120, three body parts 120, four body parts 120, or other suitable number of body parts 120. In some embodiments, the main body 120 and the rod 96 may be integral, and/or integrally formed as a single piece of material, and/or formed from a single piece of material. In some embodiments, the main body part 120 may be formed separately from the rod part 96 and fixedly attached to the rod part 96. In some embodiments, the plurality of main body parts 120 may be cut by, for example, laser cutting, machining, stamping, or stamping, It is formed from a single piece of sheet, flat, or other suitable material, and then shaped (for example, by bending, stamping, etc.) into a desired configuration. In some embodiments, the stem portion 96 may include one or more holes or apertures for receiving and/or securing the proximal end of the body portion 120 therein. In some embodiments, one or more holes or orifices may be oriented generally longitudinally relative to the stem 96. In some embodiments, a laterally oriented channel may extend through the stem 96 and intersect one or more holes or apertures. In some embodiments, a pin may be disposed inside the laterally oriented channel and engage a groove, notch, or hole in the proximal end of the main body portion 120 that is received inside one or more holes or orifices , Thereby fixing the main body 120 to the rod 96. In some embodiments, the stem 96 may have a substantially polygonal (ie, two-sided, three-sided, four-sided, five-sided, six-sided, etc.) shape. Other shapes, regular and irregular, are also conceivable. In some embodiments, when the lever portion 96 is engaged with the receiving portion or buckle 76, rotation of the lever portion 96 relative to the receiving portion or buckle 76 (ie, non-rotatable) may be prevented.

[0116] In some embodiments, the distal end of the post 72 may include a flexible mating portion 122. In some embodiments, the distal end of the post 72 may include a plurality of abutment portions 122 corresponding to and/or fixedly attached to the plurality of body portions 120. In some embodiments, the plurality of mating parts 122 may include two mating parts 122, three mating parts 122, four mating parts 122, or other suitable number of mating parts 122. In some embodiments, the mating portion 122 connects the main body portion 120 to a leg portion 124 or a plurality of legs 124 extending radially inward (relative to the anchoring member or braid 70) from the main body portion 120 of the post 72 . In some embodiments, the leg portion 124 may protrude from the mating portion 122 and/or the main body portion 120 in a cantilevered manner. In some embodiments, the plurality of legs 124 may include two legs 124, three legs 124, four legs 124, or another suitable number of legs 124. In some embodiments, the mating portion 122 may be an extension of the main body 120 of the leg 124, which is at least partially bent back onto the main body itself and transitions to the leg 124. In some embodiments, the abutment portion 122 may have and/or include a radius of curvature. For example, in some embodiments, the radius of curvature may be between 0 and 3 millimeters (mm). In some embodiments Among them, the mating portion 122 may be used to arrange the main body portion 120 and the leg portion 124 at an acute angle with respect to each other. In some embodiments, the acute angle may be between about 0 degrees and about 90 degrees, between about 3 degrees and about 60 degrees, between about 5 degrees and about 45 degrees, between about 8 degrees and about 30 degrees, Between about 10 degrees and about 20 degrees, between about 12 degrees and about 16 degrees, about 14 degrees, or another combination

Appropriate angle. In at least some embodiments, the docking portion 122 flexibly attaches the leg portion 124 to the main body portion 120 of the post 72. In some embodiments, the leg portion 124 may extend from the main body portion 120 of the post 72 toward the proximal end of the anchoring member or braid 70. In some embodiments, the leg portion 124 may be attached to the main body portion 120 of the post 72 at the distal end of the main body portion 120 of the post 72. In some embodiments, at least a portion of the leg portion 124 may longitudinally overlap the receiving portion or buckle 76 along the longitudinal center axis of the anchoring member or braid 70 in the "arranged" configuration.

[0117] In some embodiments, the leg portion 124 may include a free end 126 and a fixed end, wherein the leg portion 124 may be attached to the main body portion 120 of the post 72 at the fixed end, and the fixed end may be directly connected to the connecting portion 122. In some embodiments, multiple legs 124 may be connected together at the free end 126. In some embodiments, the plurality of legs 124 may be arranged substantially parallel to each other. In some embodiments, in addition to the leg 124 and/or the plurality of valve leaflets 68, the free end 126 of the leg 124 may not be attached (ie, not directly attached) to any other structure of the medical implant 16 . In other words, in some embodiments, the free end 126 may not be directly attached to any other structure or feature of the medical implant 16 (ie, the receiving portion or buckle 76, the anchoring member or braid 70, etc.) . In some embodiments, the most distal end of the post 72 (at least in some embodiments may be and/or include the butting portion 122) may be coupled to the distal end of the anchor member or braid 70, for example by a coupling member (such as suture). Thread, filament, thread, or other suitable means). Therefore, when the post 72 is pulled proximally to engage the receiving portion or buckle 76, the distal end of the anchoring member or braid 70 is also pulled proximally with respect to the receiving portion or buckle 76, thereby removing The configuration changes to the "arrangement" configuration.

[0118] In at least some embodiments, one or more of the plurality of valve leaflets 68 may be attached to the leg 124. In some embodiments, at least part of the plurality of valve leaflets 68 may extend and/or pass between the plurality of legs 124. In some embodiments, at least part of the plurality of valve leaflets 68 may extend and/or pass between two adjacent legs 124. In some embodiments, multiple valve leaflets 68 may be directly secured to the leg 124. In some embodiments, the plurality of valve leaflets 68 may not be directly fixed to the main body 120 and/or the stem 96 of the post 72, but instead are coupled to the post 72 via the legs 124. In some embodiments, multiple valve leaflets 68 may wrap around the leg 124. In some embodiments, at least part of a plurality of valve leaflets 68 extending between and/or passing through two adjacent legs 124 may be wrapped around two adjacent legs 124. In some embodiments, the most distal end of the plurality of valve leaflets 68 may be coupled to the distal end of the anchoring member or braid 70. In some embodiments, one or more sutures, threads, wires, filaments, or other suitable elements may be used to couple and/or fix multiple valve leaflets 68 (ie, to the leg 124, to the anchoring member Or braid 70, and/or back to themselves). In some embodiments, adhesives, adhesives, or other suitable fixing means may be used to connect multiple valve leaflets 68 and/or Fixed (ie, to the leg 124, to the anchoring member or braid 70, and/or back to themselves). In some embodiments, fabrics, textiles, or other thin flexible materials may be used to couple and/or fix multiple valve leaflets 68 (ie, to the legs 124, to the anchoring member or braid 70, and/or Back to themselves).

[0119] In some embodiments, the handle 18 may include a handle housing. The rotatable control knob can be provided near the handle housing (for example, at the proximal end of the handle housing), and can be used to enable one or more components of the medical device system 10 (for example, the outer sheath 12, the push-pull rod 84, Etc.) Move. The rotatable fixing ring may be provided near the handle housing. The control knob can be arranged near the proximal end of the rotatable fixed ring. The slidable door can also be arranged near the handle housing. The slidable door can be translated distally, thereby exposing the distal end of the rotatable fixing ring positioned generally under the slidable door. The rotatable fixed ring can be rotated to move one or more components of the medical device system 10 (eg, push-pull rod 84, pin release mandrel 92, etc.). The handle 18 may also include one or more orifices and/or irrigation ports that can be used to flush the medical device system 10. In some embodiments, the distal flush port and the proximal flush port can be entered from the outside of the handle housing through the distal orifice and the proximal orifice, respectively.

[0120] The proximal end of the inner catheter 14 may be attached (eg, fixedly attached) to the inner body or diverter. The diverter can be attached to the supporting body. Generally speaking, the diverter and/or support body may have one or more channels or lumens formed therein. In some embodiments, the drive element or push-pull rod 84 and/or pin release mandrel 92 may extend through respective channels. Alternatively, the proximal end of the drive element or push-pull rod 84 and/or pin release mandrel 92 may each be attached to a shaft or hypotube (for example, solid, tubular, etc. in cross-section), and each shaft may Extend through one or more channels. For example, the first shaft or hypotube and the second shaft or hypotube may extend through the passage in the diverter, in some embodiments the first shaft or hypotube extends through the first passage and the second shaft or hypotube The wave tube extends through a second channel separated or separated from the first channel. In at least some embodiments, the first shaft is attached to the pin release mandrel 92. In at least some embodiments, the second shaft is attached to the drive element or push-pull rod 84. As mentioned above, in at least some embodiments of the medical device system 10, three drive elements or push-pull rods 84 are used. In these embodiments, the three drive elements or push-pull rods 84 converge at a location adjacent to the distal end of the inner catheter 14 (eg, move into contact with each other or relatively close to each other) and enter the first lumen. At one along their length Or multiple positions, drive elements or push-pull rods 84 can be attached to each other. For example, in some embodiments, the drive elements or push-pull rods 84 may be welded together at a distance of about 10.16 cm (about 4.00 inches) from their distal ends. In some embodiments, in addition to or instead of welding at the distal end, the drive elements or push-pull rods 84 may be welded together immediately adjacent to their proximal ends. Shortly thereafter, the drive element or push-pull rod 84 may extend to the second shaft.

[0121] The hypotube (for example, a hypotube lining placed along the lumen of the guide wire) can extend through the diverter inside the channel therein, and then "turn" around a part of the diverter and the support body, and finally extend To a position at the proximal end of the handle 18 to provide the user with access to the guidewire lumen. A proximal flushing port that can be used to flush the lumen of the inner catheter 14 and, for example, can function similar to a distal flushing port can be provided on the support body.

[0122] At their respective proximal ends, the first shaft may be fixed to the slider and the second shaft may be fixed to the force limiter body. The connection between various components may include several different types of connections, including mechanical bonding (for example, pinning, threading, interference fit, etc.), adhesive bonding, thermal bonding, and so on. The slider can slide relative to the force limiter body. In some embodiments, the slider may be selectively locked to the force limiter body, thereby preventing relative movement between the slider and the force limiter body. The force limiter body may be fixed to a push-pull rod bracket, and the push-pull rod bracket may be screwed to the lead screw. Therefore, the movement of the lead screw may result in the movement of the push-pull rod bracket and the force limiter body and therefore the drive element or push-pull rod 84 (via the second shaft).

[0123] Generally speaking, the force limiter body is formed or defined to provide the user with tactile feedback to indicate that the drive element or push-pull rod 84 has been retracted proximally for a sufficient distance to lock the post 72 with the buckle 76. Points (for example, resistance to further rotation of the control knob). In order to verify the correct locking, the clinician can use appropriate visualization techniques to visualize the correct locking (eg, the relative positioning of the post 72 and the hasp 76). The wedge may be positioned adjacent to the slider to selectively lock the slider to the force limiter body. To allow the pin release mandrel 92 to be retracted proximally to the pulling pin 88, the wedge can be rotated or moved to a second position or configuration. When in this configuration, the wedge no longer forms an obstacle to further movement of the slide and pin release mandrel 92, for example. Therefore, the wedge used for the wedge no longer functions as an obstacle, and the slider and pin release mandrel 92 can be retracted proximally to facilitate the placement of the medical implant 16 by allowing the pin 88 to be pulled.

[0124] The handle 18 also includes a rotatable ring having internal teeth for meshing with teeth on a gear coupled to the lead screw. The ring is coupled to the control knob so that rotation of the control knob causes similar movement of the ring and therefore the lead screw.

[0125] The handle 18 is generally used for coordinated movement of multiple structures of the medical device system 10. For example, the handle 18 is used to allow the user to move the outer sheath 12 (for example, relative to the inner catheter 14), move the drive element or push-pull rod 84, and make

The pin release mandrel 92 moves. In addition, the handle 18 is used to allow the appropriate structure to move at the appropriate time during the intervention, so that the medical implant 16 can be delivered and released in an efficient manner. Some examples of how coordinated movement of the medical device system 10 can be performed inside the handle 18 may be similar to the examples disclosed in US Patent Application Publication US 2010/0280495, the entire content of which is incorporated herein by reference.

[0126] To help facilitate coordinated movement, the handle 18 may include an idling cylinder. The idle cylinder is used for threaded engagement with the sheath bracket and push-pull rod bracket and/or the sheath and push-pull rod bracket at different times during the intervention to stop the movement (for example, cause the appropriate bracket "Idling"). For example, in the first position or state for the handle 18, the outer sheath 12 extends distally relative to the inner catheter 14 (and the handle 18) so as to completely envelop (eg, house) the medical implant 16. In this position, the sheath bracket is positioned adjacent to the distal end of the handle 18. In addition, the screw rod associated with the push-pull rod bracket extends distally from the push-pull rod bracket and is positioned inside the idling cylinder. When the control knob is rotated (for example, in a clockwise direction), the lead screw starts to rotate. The rotation of the lead screw causes the sheath bracket to move along the lead screw in the proximal direction, thereby causing proximal movement of the outer sheath 12 (eg, "pulling out" the medical implant 16). The initial rotation of the lead screw also causes the screw to rotate. This may be because, for example, a knob or protrusion (not shown) on the screw can be engaged with a helical thread provided along the inside of the idling cylinder. However, because the screw is spaced from the push-pull rod bracket, it does not exert force on the push-pull rod bracket. Therefore, the initial movement of the control knob does not cause the movement of the push-pull rod bracket, but only causes the translation of the sheath bracket and the rotation (translation) of the screw.

[0127] Finally, the screw (eg, a knob formed therein) reaches a generally linear thread or a channel formed at the end of the idle cylinder. The linear thread allows the screw to translate along the lead screw to a position where the screw (eg, screwed inside and abutting) is in contact with the push-pull rod bracket. In this case, the screw can contact the push-pull rod bracket and move proximally. Therefore, further rotation of the lead screw not only causes the sheath bracket to move proximally but also causes the push-pull rod bracket to move proximally.

[0128] When the sheath bracket reaches the idle cylinder, the sheath bracket of the sheath bracket threaded into the idle cylinder. This can be done in a similar manner to the screw and the helical screwing and drilling formed along the idling cylinder. For example, when the sheath bracket is translating, the sheath bracket threads may follow a substantially linear thread or channel formed along or adjacent to the idle cylinder. When reaching the idling cylinder, the sheath bracket threads (for example, the knobs or protrusions on each other) can be displaced to a position to engage with the spiral threads inside the idling cylinder and rotate. This rotation "drills" the sheath bracket threads out of the sheath bracket. Therefore, the additional rotation of the lead screw causes the continuous proximal movement of the push-pull rod bracket while stopping the movement of the sheath bracket.

[0129] At least in some embodiments, the lead screw has multiple portions, such as a first portion and a second portion having different pitches to its threads. This may allow the sheath and push-pull rod carrier to travel along the lead screw at different rates. For example, the pitch of the lead screw along which the sheath bracket translates may generally be more spaced or inclined than at a position adjacent to the push-pull rod bracket. Therefore, the coordinated movement of the sheath and the push-pull rod bracket can also be configured such that the sheath carrier translates along the lead screw at a faster rate than the push-pull rod bracket. Other configurations in which the above-mentioned configuration is inverted are conceivable, and other configurations in which the pitch of the lead screw is substantially constant or includes several different pitch regions.

[0130] Sufficient proximal retraction of the push-pull rod bracket may cause the drive element or push-pull rod 84 to be fully retracted so that the post 72 can engage with the hasp 76 and be locked by the hasp 76. When the clinician determines that the locking is complete (for example, after confirmation by a suitable visualization technique), the clinician can retract the release mandrel 92 proximally to remove the pin 88 from the opening 98 and the thin in the drive element or push-pull rod 84 Pull out from the long orifice or slot to release the medical implant 16.

[0131] To initiate the release of the pin 88, the door can be slid distally along a fixed ring located on the handle 18. When making the door fully

When traveling, the door and the fixed ring can rotate together about the longitudinal axis of the handle 18. The push-pull rod bracket may also include a radially extending proximal marking member. Generally speaking, the sign member can be designed with features that can prevent the fixed ring from rotating earlier than expected (thus, preventing the pin from being pulled earlier than expected). For example, the marking member may be located inside the groove and follow the groove along the inside of the fixed ring. When positioned inside the groove, the marking member generally forms a physical barrier that prevents the fixing ring from rotating relative to the handle housing. When the push-pull rod bracket is translated proximally to the back of the handle housing (for example, when the drive element or push-pull rod 84 is retracted proximally to lock the post 72 with the buckle 76), the marking member is disengaged from Groove in the retaining ring. Therefore, the indicator member no longer prevents the rotation of the fixed ring, so the fixed ring can now be rotated to pull the pin 88.

[0132] The fixed ring is connected to the gear engaged with the second thread via a ring. The notch at the proximal end of the fixed ring engages with the protrusion on the ring, so that rotation of the fixed ring causes a corresponding rotation of the ring and therefore the second thread. The initial rotation of the fixed ring is sufficient to allow the wedge from which the slide (and therefore the pin release mandrel 92) to be selectively locked into the first configuration of the force limiter body (for example, by the fixed ring that causes the wedge to be displaced) The mechanical interaction with the wedge) is rotated to a second configuration that allows the slider to translate along the second thread as the second thread rotates, thereby retracting proximally and pulling the pin 88 (for example, using the pin to release the mandrel 92 ). The wedge in the first configuration engages the ridge along the top of the force limiter body, which forms a physical barrier that prevents the slider from translating proximally relative to the force limiter body. When the fixed ring is rotated to the wedge displacement into the second configuration, the fixed ring rotates around the handle housing to remove the pin 88 from the distal opening 98 and the elongated aperture or groove of the drive element or push-pull rod 84 When pulled out, the slider can translate proximally inside the groove provided in the top of the force limiter body. Once the pin 88 has been removed, the drive element or push-pull rod 84 can be pulled out of the medical implant 16, thereby releasing the implant at the target site (area of interest).

[0133] After the release of the medical implant 16, the control knob can be rotated to move the sheath bracket distally inside the handle housing, thereby making the outer sheath 12 relative to the inner catheter 14 and the coupling 78 Move to the distal side, thereby covering or re-coating the components of the medical device system 10 disposed at the distal end. Then, the medical device system 10 can be removed from the patient's anatomy.

[0134] The materials that can be used for the various components of the medical device system 10 (and/or other systems disclosed herein) and the various tubular members disclosed herein can include tubular members generally associated with medical devices. For the sake of simplicity, the following description refers to the outer sheath 12 and/or the inner catheter 14. However, this is not intended to limit the devices and methods described herein, because the description can be applied to the tubular members or other similar tubular members and/or components of the devices disclosed herein, such as but not limited to drive elements or push-pull rods, The unlocked member, the first locking portion, the second locking portion, and/or elements or parts thereof.

[0135] In some embodiments, the outer sheath 12 and/or the inner catheter 14 may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composite materials, ceramics, combinations thereof, etc., or Made of other suitable materials. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; sickle-titanium alloys, such as linear elastic and/or super-elastic titanium alloys; other sickle alloys, such as sickle-ribbon Button alloys (for example, UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®, other HASTFSLLOY® alloys, etc.), sickle-copper alloy ( For example, UNS: N04400, such as MONEL®400, MICKELVACi&400, NICORROS®400, etc.), sickle-drill-yong-button alloy (for example, UNS: R30035, etc.), nickel-button alloy (for example, UNS: N10665, Such as TELLOY® alloy B2®, other sickle-yong alloys, other sickle-button alloys, other sickle-drill alloys, other sickle-iron alloys, other sickle-copper alloys, other sickle-hook or hook alloys, etc.; drill-yong alloys, etc. Alloy; drill-yong-button alloy (for example, UNS: R30003, such as

ELGILOYJC, PHYNOX1?, etc.); pliers-rich stainless steel; titanium; combinations thereof, etc.; or, any other suitable materials.

[0136] As mentioned herein, in the family of commercially available sickle-titanium or sickle-titanium alloys are the categories named "linear elastic" or "non-superelastic", although they may be similar in chemical nature In conventional shape memory and super elastic varieties, it can show unique and useful mechanical properties. The difference between linear elastic and/or non-superelastic Nitinol and superelastic Nitinol is that linear elastic and/or non-superelastic titanium alloy does not show obvious "superelastic plateaus" in its stress/strain curve. "Or "marking area", like a super-elastic titanium alloy. In contrast, in linear elastic and/or non-superelastic titanium alloys, when the recoverable strain increases, the stress continues to increase in a substantially linear or slightly but not necessarily completely linear relationship, until the plastic deformation begins or at least the The super-elastic plateau area and/or the mark area that can be seen in the elastic sickle titanium alloy have a more linear relationship. Therefore, for the purposes of this disclosure, linear elastic and/or non-superelastic titanium alloys may also be referred to as "substantially" linear elastic and/or non-superelastic titanium alloys.

[0137] In some cases, the difference between linear elastic and/or non-super-elastic titanium alloy and super-elastic titanium alloy is that: linear elastic and/or non-super-elastic titanium alloy can accept more than 2-5 % Strain while still being substantially elastic (for example, before plastic deformation), while superelastic titanium alloys can accept up to about 8% strain before plastic deformation. These two materials can be distinguished from other linear elastic materials, such as stainless steel that can accept a strain of only about 0.2 to 0.44% before plastic deformation (it can also be distinguished based on its composition).

[0138] In some embodiments, linear elastic and/or non-superelastic sickle-titanium alloys can be detected in a large temperature range by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis. , Does not show any martensite/austenite transformation alloy. For example, in some embodiments, there may be no linear elastic and/or non-superelastic sickle-titanium alloys that can be detected in the range of about -60 degrees Celsius (°C) to about 120°C using DSC and DMTA analysis. Austenite/Austenitic transformation. Therefore, the mechanical bending properties of this material are generally inert to the temperature influence in this very large temperature range. In some embodiments, the mechanical bending properties of linear elastic and/or non-superelastic sickle-titanium alloys at ambient temperature or room temperature are approximately the same as the mechanical properties at body temperature, for example, they do not show superelastic plateaus and/ Or sign area. In other words, in a large temperature range, the linear elastic and/or non-superelastic Si-titanium alloy maintains its linear elastic and/or non-superelastic properties and/or performance.

[0139] In some embodiments, the linear elastic and/or non-superelastic sickle-titanium alloy may contain sickle in the range of about 50 to about 60% by weight, with the remaining base being titanium. In some embodiments, the composition is sickle in the range of about 54 to about 57% by weight. An example of a suitable Shino-titanium alloy is the FHP-NT alloy available from Furukawa Technical Materials Co., Kanagawa, Japan. Some examples of titanium alloys are disclosed in U.S. Patent Nos. 5,238,004 and 6,508,803, and the contents of these patents are incorporated herein by reference. Other suitable materials may include ULTANIUMTM (available from Neo-Metrics) and GUM metal tm (available from Toyota). In some other embodiments, superelastic alloys (such as superelastic titanium alloy) can be used to obtain the desired properties.

[0140] At least in some embodiments, part or all of the outer sheath 12 and/or the inner catheter 14 can also be doped with, made of, or contain radiopaque materials. Radiopaque materials It is understood as a material that can form a relatively bright image (or through another imaging technique) on a fluorescent screen during a medical operation. This relatively bright image can help the user of the medical device system 10 to determine its location. Some examples of radiopaque materials may include, but are not limited to: gold, tongs, rakes, tongs, hook alloys, polymer materials loaded with radiopaque fillers, and the like. In addition, other radiopaque marker tapes and/or coils can also be incorporated into the design of the medical device system 10 to achieve the same result.

[0141] In some embodiments, a certain degree of magnetic resonance imaging (MRI) compatibility is given to the medical device system 10. example

For example, the outer sheath 12 and the inner catheter 14 or parts thereof may be made of materials that do not significantly distort the image and produce obvious artifacts (ie, gaps in the image). Certain ferromagnetic materials may be unsuitable, for example, because they can form artifacts in MRI images. The outer sheath 12 and the inner catheter 14 or their parts can also be made of materials that can be imaged by an MRI machine. Some materials exhibiting these characteristics include, for example, hooks, drill-yong-button alloys (for example, UNS: R 3 0 0 0 3, such as ELGILOY®. PHYNOX®, etc.), nickel-drill-chong-aluminum alloys (for example, UNS : R30035, such as MP35-N®, etc.), sickle titanium alloy, etc., and others.

[0142] A sheath or cover (not shown) may be provided over part or all of the outer sheath 12 and the inner catheter 14. The outer sheath 12 and the inner catheter 14 may define Usually it has a smooth outer surface. However, in other embodiments, such a sheath or cover may be missing from a portion of the entire medical device system 10, so that the outer sheath 12 and the inner catheter 14 may form an outer surface. The sheath can be made of polymer or other suitable materials. Some examples of suitable polymers may include: polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, such as DELRIN available from DuPont) ®), poly-block ester, polyurethane (for example, polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), poly-ester (for example, ARNITELS purchased from DSM Engineering Plastics;), based on Copolymers of ferric or esters (for example, butylene phthalate/poly(alkyl ether) and/or other polyester elastomers, such as HYTREL® available from DuPont)> polyamide (for example, from Bayer or DURETHAN® purchased by Elf Atochem Company), elastomer polyamides, block polyamines/sucroses, polyamides block amides (PEBA, for example, commercially available Product name PEBAX repurchased), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE). Marlex high-density polyethylene. Marlex low-density polyethylene, linear low-density polyethylene (such as REXELL back), poly Ester, Polybutylene Terephthalate (PBT), Polyethylene Terephthalate (PET), Polytrimethylene Terephthalate, Polyethylene Dicarboxylate (PEN), Polyketone (PEEK), polyimide (PI), polyimide (PEI), polyphenylene sulfide (PPS), polyphenylene (PP0), polyparaphenylene terephthalamide (for example, KEVLAR ®) >Poly inkstone, nylon, nylon T2 (such as GRILAMID® purchased from EMS American Grilon), perfluoro (n-propyl vinyl alcohol) (PFA), ethylene-vinyl alcohol copolymer, polyolefin billet, poly Styrene, epoxy resin, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, S1BS and/or SIBS 50A), polycarbonate, ionomer Materials, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composite materials, etc. In some embodiments, the sheath may be mixed with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0143] In some embodiments, the outer surface of the medical device system 10 (including, for example, the outer surface of the outer sheath 12 and the inner catheter 14) may be sandblasted, shot blasted, sprayed with sodium bicarbonate, and polished by electrolysis, Wait. In these embodiments and in some other embodiments, or in embodiments where there is no sheath over part of the outer sheath 12 and inner catheter 14 or other parts of the medical device system 10, a coating (eg A lubricating, hydrophilic, protective, or other type of coating) is applied to part or the front of the sheath. Alternatively, the sheath may include a lubricating, hydrophilic, protective, or other type of coating. Hydrophobic coatings (such as fluoropolymers) provide dry lubricity that improves device handling and device exchange. The lubricious coating improves maneuverability and improves damage passing performance. Suitable lubricating polymers are well known in the art and may include hydrophilic polymers such as silicone, such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyoxyarylene, polyvinylpyrrole Alkanone, polyvinyl alcohol, vat-based alkyl cellulose, algin, sugars, caprolactone, etc., and mixtures and combinations thereof. Hydrophilic polymers can be mixed in themselves or with formulated amounts of water-insoluble compounds (including some polymers) to obtain coatings with suitable lubricity, adhesion, and solubility. This coating and the materials and methods used to form this coating Some other examples of methods can be found in, for example, US Patent Nos. 6,139,510 and 5,772,609, the contents of which are incorporated herein by reference.

[0144] The coating and/or sheath can be formed, for example, by coating, extrusion, coextrusion, interrupted layer coextrusion (ILC), or end-to-end fusion. The layer may have uniform stiffness or a stiffness that gradually decreases from the proximal end to its distal end. The gradual decrease in stiffness may be continuous, such as by ILC, or may be stepped, such as by fusing together separate extruded tubular sections. The outer layer can be impregnated with a radiopaque filler material to facilitate radiographic visualization. Those skilled in the art will recognize that these materials can vary widely without departing from the scope of the invention.

[0145] The entire contents of the following documents are incorporated herein by reference: U.S. Patent Application Publication US 2007/0112355; U.S. Patent Application Publication US 2010/0219092; U.S. Patent Application Publication US 2010/0280495; U.S. Patent Application Publication US 2011 /0257735; US Patent Application Publication US 2013/0123796; and US Patent Application Publication US 2013/0158656o

[0146] It should be understood that many aspects of this disclosure are merely illustrative. Without exceeding the scope of the present invention, changes can be made in details, especially in terms of shape, size, and arrangement of steps. To the extent appropriate, this may include the use of any feature of an exemplary embodiment used in other embodiments. Of course, the scope of the present invention is limited to the terms in which the appended claims are expressed.