Wedge-lock sheath retention mechanism

Abstract

A medical device may include a sheath, a push wire, and a locking element. The push wire may be slidably disposed within a cavity of the sheath. The locking element may have a proximal end, a distal end, an intermediate region disposed between the proximal end and the distal end, and a cavity extending from the proximal end to the distal end. The locking element may have a first inner diameter adjacent to the distal end and a second inner diameter adjacent to the proximal end, the second inner diameter being smaller than the first inner diameter. The distal region of the locking element may be configured to slide freely on the sheath, and when the proximal region of the locking element is disposed on the sheath, the locking element may be configured to press the sheath radially inward.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 904,864, filed September 24, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This invention relates to medical devices and methods for manufacturing and / or using medical devices. More particularly, this invention relates to the construction of a system for securing a medical device within a sheath. Background Technology

[0004] A wide variety of in vivo medical devices have been developed for medical applications, such as surgical and / or endovascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.). These devices are manufactured using any of a wide variety of different manufacturing methods and can be used according to any of these methods. There is currently a need for alternative medical devices and alternative methods for manufacturing and / or using these devices. Summary of the Invention

[0005] In a first example, a medical device system may include a sheath having a proximal end, a distal end, an intermediate region disposed between the proximal and distal ends, and a cavity extending from the proximal end to the distal end; an actuating wire slidably disposed within the cavity of the sheath; and a locking element having a proximal end, a distal end, an intermediate region disposed between the proximal and distal ends, and a cavity extending from the proximal end to the distal end. The locking element may have a first inner diameter adjacent to the distal end and a second inner diameter adjacent to the proximal end, the second inner diameter being smaller than the first inner diameter. The distal region of the locking element may be configured to slide freely on the sheath. When the proximal region of the locking element is disposed on the sheath, the locking element may be configured to press the sheath radially inward.

[0006] Alternatively or additionally for any of the above examples, in another example, the diameter of the cavity of the locking element in the proximal region may be reduced in an inclined manner toward the proximal end of the locking element.

[0007] Alternatively or additionally, in another example, the cavity of the locking element in the distal region may have a substantially uniform inner diameter, in any of the above examples.

[0008] Alternatively or additionally for any of the above examples, in another example, the sheath may include a first slot and a second slot, the first and second slots extending distally from the proximal end of the sheath and extending less than the entire length of the sheath.

[0009] Alternatively or additionally for any of the above examples, in another example, the sheath may include a longitudinally extending slot extending distally from the proximal end of the sheath.

[0010] Alternatively or additionally for any of the above examples, in another example, the longitudinally extending slot may terminate at a circumferentially extending slit.

[0011] Alternatively or additionally for any of the above examples, in another example, the sheath may include angled protrusions extending radially outward from its outer surface.

[0012] Alternatively or additionally, in another example, the diameter of the angled protrusion of the sheath may decrease in the proximal direction, in any of the above examples.

[0013] Alternatively or additionally for any of the above examples, in another example, the locking element may include an angled protrusion extending radially inward from the inner surface of the cavity of the locking element.

[0014] Alternatively or additionally, in another example, the diameter of the angled protrusion of the locking element may decrease in the direction toward the distal end, in any of the above examples.

[0015] Alternatively or additionally, in another example, the angled protrusions of the sheath and the angled protrusions of the locking element may be configured to cooperate to restrict axial movement of the locking element, in any of the above examples.

[0016] Alternatively or additionally for any of the above examples, in another example, the locking element may also include a slot extending from the proximal end of the locking element to the distal end of the locking element, the slot extending through the thickness of the wall of the locking element.

[0017] Alternatively or additionally for any of the above examples, in another example, the slot may have a width greater than the width of the push wire and less than the width of the sheath.

[0018] Alternatively or additionally for any of the above examples, in another example, the locking element may include a plurality of circumferentially extending ribs extending from its outer surface.

[0019] In any of the above examples, alternatively or additionally, in another example, the locking element may be formed of a material that is more rigid than the sheath.

[0020] In another example, a medical device system may include a sheath having a proximal end, a distal end, an intermediate region disposed between the proximal and distal ends, and a cavity extending from the proximal end to the distal end. The sheath has a first slot and a second slot extending distally from the proximal end of the sheath for less than the entire length of the sheath and defining a first flexible arm and a second flexible arm; an actuating wire slidably disposed within the cavity of the sheath; and a locking element having a proximal end, a distal end, an intermediate region disposed between the proximal and distal ends, and a cavity extending from the proximal end to the distal end. The locking element has a first inner diameter adjacent to the distal end and a second inner diameter adjacent to the proximal end, the second inner diameter being smaller than the first inner diameter. The distal region of the locking element may be configured to slide freely on the sheath. When the proximal region of the locking element is disposed on the proximal region of the sheath, the locking element may be configured to press the first and second flexible arms radially inward.

[0021] Alternatively or additionally for any of the above examples, in another example, the diameter of the cavity of the locking element in the proximal region may be reduced in an inclined manner toward the proximal end of the locking element.

[0022] Alternatively or additionally, in another example, the cavity of the locking element in the distal region may have a substantially uniform inner diameter, in any of the above examples.

[0023] Alternatively or additionally for any of the above examples, in another example, the locking element may also include a slot extending from the proximal end of the locking element to the distal end of the locking element, the slot extending through the thickness of the wall of the locking element.

[0024] Alternatively or additionally for any of the above examples, in another example, the slot may have a width greater than the width of the push wire and less than the width of the sheath.

[0025] Alternatively or additionally for any of the above examples, in another example, the locking element may include a plurality of circumferentially extending ribs extending from its outer surface.

[0026] Alternatively or additionally for any of the above examples, in another example, the locking element may have a substantially uniform wall thickness from the proximal end to the distal end of the locking element.

[0027] Alternatively or additionally for any of the above examples, in another example, the locking element may have a first wall thickness near the proximal end and a second wall thickness near the distal end, the first wall thickness being greater than the second wall thickness.

[0028] In another example, a medical device system may include a sheath having a proximal end, a distal end, an intermediate region disposed between the proximal and distal ends, and a cavity extending from the proximal end to the distal end. The sheath also includes a longitudinally extending slot extending distally from the proximal end of the sheath; an actuating wire slidably disposed within the cavity of the sheath; and a locking element having a proximal end, a distal end, an intermediate region disposed between the proximal and distal ends, and a cavity extending from the proximal end to the distal end, the cavity of the locking element being generally hourglass-shaped. The distal region of the locking element may be configured to slide freely on the sheath. When the intermediate region of the locking element is disposed on the sheath, the locking element may be configured to press the sheath radially inward.

[0029] Alternatively or additionally for any of the above examples, in another example, the longitudinally extending slot of the sheath may terminate at a circumferentially extending slit.

[0030] In any of the above examples, alternatively or additionally, in another example, the sheath may also include a first wing and a second wing adjacent to the longitudinally extending slot.

[0031] Alternatively or additionally for any of the above examples, in another example, the locking element may have a first inner diameter adjacent to the distal end and a second inner diameter adjacent to the intermediate region, the second inner diameter being smaller than the first inner diameter.

[0032] In any of the above examples, alternatively or additionally, in another example, the second inner diameter may be substantially constant and extend between the distal and proximal regions of the flare.

[0033] In another example, a medical device system may include a sheath having a proximal end, a distal end, an intermediate region disposed between the proximal and distal ends, and a cavity extending from the proximal end to the distal end. The sheath also includes an angled protrusion extending radially outward from its outer surface; an actuating wire slidably disposed within the cavity of the sheath; and a locking element. The locking element may include a proximal end, a distal end, an intermediate region disposed between the proximal and distal ends, and a cavity extending from the proximal end to the distal end. The locking element has a first inner diameter adjacent to the distal end, a second inner diameter adjacent to the proximal end, and an angled protrusion extending radially inward from the inner surface of the cavity of the locking element, the second inner diameter being smaller than the first inner diameter. The distal region of the locking element may be configured to slide freely on the sheath. When the proximal region of the locking element is disposed on the sheath, the locking element may be configured to press the sheath radially inward.

[0034] Alternatively or additionally, in another example, the diameter of the angled protrusion of the sheath may decrease in the proximal direction, in any of the above examples.

[0035] Alternatively or additionally, in another example, for any of the above examples, the angled protrusion of the sheath may be positioned near the proximal end of the sheath.

[0036] Alternatively or additionally, in another example, the diameter of the angled protrusion of the locking element may decrease in the direction toward the distal end, in any of the above examples.

[0037] Alternatively or additionally, in another example, the angled protrusion of the locking element may be positioned at the distal end adjacent to the locking element, in any of the examples above.

[0038] Alternatively or additionally, in another example, the angled protrusions of the sheath and the angled protrusions of the locking element may be configured to cooperate to restrict axial movement of the locking element, in any of the examples above.

[0039] Alternatively or additionally for any of the above examples, in another example, the diameter of the cavity of the locking element in the proximal region may be reduced in an inclined manner toward the proximal end of the locking element.

[0040] The above overview of some embodiments, aspects, and / or examples is not intended to describe every embodiment or implementation of the invention. These embodiments are illustrated more specifically by way of example in the following figures and detailed description. Attached Figure Description

[0041] The invention can be more fully understood by considering the following detailed description of various embodiments taken in conjunction with the accompanying drawings, in which:

[0042] Figure 1 This is a three-dimensional diagram of an example medical device system in the first form;

[0043] Figure 2 It is a three-dimensional diagram illustrating the locking mechanism;

[0044] Figure 3 yes Figure 2 A cross-sectional view of the illustrative locking mechanism;

[0045] Figure 4 This is a three-dimensional diagram of another illustrative locking mechanism;

[0046] Figure 5 yes Figure 4 A cross-sectional view of the illustrative locking mechanism;

[0047] Figure 6 This is a three-dimensional diagram of another illustrative locking mechanism;

[0048] Figure 7 Figure 6A cross-sectional view of the illustrative locking mechanism;

[0049] Figure 8 It is in the second form Figure 1 A three-dimensional diagram illustrating a medical device system;

[0050] Figure 9 yes Figure 8 A partial cross-sectional view of an illustrative medical device system;

[0051] Figure 10 It is in the third form Figure 1 and Figure 8 A three-dimensional diagram illustrating a medical device system;

[0052] Figure 11 yes Figure 10 A partial cross-sectional view of an illustrative medical device system;

[0053] Figure 12 This is a three-dimensional view of another example medical device system in the first form;

[0054] Figure 13 yes Figure 12 A partial cross-sectional view of an illustrative medical device system;

[0055] Figure 14 This is a three-dimensional diagram of another illustrative locking mechanism;

[0056] Figure 15 yes Figure 14 A cross-sectional view of the illustrative locking mechanism;

[0057] Figure 16 It is in the second form Figure 12 A three-dimensional diagram illustrating a medical device system;

[0058] Figure 17A yes Figure 16 A partial cross-sectional view of an illustrative medical device system;

[0059] Figure 17B yes Figure 17A A partial cross-sectional view of an illustrative medical device system;

[0060] Figure 18 This is a three-dimensional view of another example medical device system in the first form;

[0061] Figure 19 yes Figure 18 A partial cross-sectional view of an illustrative medical device system;

[0062] Figure 20 It is in the second form Figure 18A partial cross-sectional view of an illustrative medical device system;

[0063] Figure 21 This is a three-dimensional diagram of another illustrative locking mechanism;

[0064] Figure 22 yes Figure 21 A cross-sectional view of the illustrative locking mechanism;

[0065] Figure 23 This is a three-dimensional view of another example medical device system in the first form;

[0066] Figure 24 It is a three-dimensional diagram illustrating the locking mechanism;

[0067] Figure 25 yes Figure 24 A cross-sectional view of the illustrative locking mechanism;

[0068] Figure 26 yes Figure 24 A remote view of the illustrative locking mechanism;

[0069] Figure 27 It is a three-dimensional diagram illustrating the locking mechanism;

[0070] Figure 28 yes Figure 27 An illustrative three-dimensional cross-sectional view of the locking mechanism; and

[0071] Figure 29 yes Figure 27 A remote view of the illustrative locking mechanism.

[0072] While various aspects of the invention are adaptable to numerous modifications and alternatives, their specific details have been shown by way of example in the accompanying drawings and will be described in more detail. However, it should be understood that it is not intended to limit the aspects of the invention to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. Detailed Implementation

[0073] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein the same reference numerals in several views indicate the same elements. The detailed description and drawings are intended to illustrate, and not limit, the claimed invention. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of the invention. The detailed description and drawings illustrate exemplary embodiments of the claimed invention. However, for purposes of clarity and ease of understanding, although not every feature and / or element may be shown in every drawing, features and / or elements may be understood to be present unless otherwise stated.

[0074] For the purposes of the following definitions, unless otherwise specified in the claims of this specification or elsewhere, these definitions shall apply.

[0075] All numerical values ​​herein are assumed to be modified by the term "about," whether or not explicitly stated. In the context of numerical values, the term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the referenced value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure. Unless otherwise specified, other uses of the term "about" (e.g., in contexts other than numerical values) may be assumed to have their common and customary definition, as understood and consistent with the context of this specification.

[0076] A reference to a range of numbers represented by an endpoint includes all numbers in that range, including the endpoint (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0077] While some suitable dimensions, ranges and / or values ​​for various components, features and / or specifications are disclosed, those skilled in the art to whom this invention relates will understand that desired dimensions, ranges and / or values ​​can be derived from those explicitly disclosed.

[0078] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include a plural indication unless the content expressly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used in the sense of including “and / or” unless the content expressly indicates otherwise. It should be noted that, for ease of understanding, certain features of the invention may be described in the singular, even if those features may be plural or repeated in the disclosed embodiments. Each instance of a feature may include and / or contain a singular disclosure unless expressly stated otherwise. For simplicity and clarity, not all elements of the disclosed invention need to be shown in every figure or discussed in detail below. However, it will be understood that, unless expressly stated otherwise, the following discussion applies equally to any and / or all of more than one component. Additionally, for clarity, not all instances of some elements or features may not be shown in each figure.

[0079] Relative terms, such as “proximal,” “distal,” “advance,” “retract,” and variations thereof, are generally considered in relation to the positioning, orientation, and / or operation of various elements relative to the user / operator / manipulator of the device, wherein “proximal” and “retract” indicate or refer to being closer to or towards the user, and “distal” and “advance” indicate or refer to being farther from or away from the user. In some instances, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of the invention, and such instances will be apparent to those skilled in the art. Other related terms, such as “upstream,” “downstream,” “inflow,” and “outflow,” refer to the direction of fluid flow within a cavity, such as a body cavity, blood vessel, or device. Other relative terms, such as “axial,” “circumferential,” “longitudinal,” “lateral,” “radial,” and / or variations thereof, generally refer to the direction and / or orientation relative to the central longitudinal axis of the disclosed structure or device.

[0080] It should be noted that the embodiments described by references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification may include specific features, structures, or characteristics, but each embodiment may not necessarily include that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, whether explicitly described or not, implementation of such a feature, structure, or characteristic in conjunction with other embodiments is within the knowledge of those skilled in the art, unless the contrary is explicitly stated. That is, even if not explicitly shown in a specific combination, the various individual elements described below are still considered to be combinable or arranged together to form other additional embodiments or to supplement and / or enrich the described embodiments, as will be understood by those skilled in the art.

[0081] For clarity, a distinctive numerical designation (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various described and / or claimed features. It is to be understood that the numerical designation is not intended to be limiting and is merely exemplary. In some embodiments, for brevity and clarity, the numerical designation may be modified and deviated from previously used. That is, a feature identified as a “first” element may later be referred to as a “second” element, a “third” element, etc., or may be omitted entirely, and / or a different feature may be referred to as a “first” element. The meaning and / or name in each case will be obvious to a person skilled in the art.

[0082] Diseases and / or medical conditions affecting and / or influencing the cardiovascular system are prevalent worldwide. For example, some forms of arteriovenous malformations (AVMs) may be unable to "supply" normal blood flow through the vascular system. Without being bound by theory, it is believed that AVMs and / or other diseases or conditions can be at least partially treated by depriving them of normal, oxygenated, and / or nutrient-rich blood flow, thereby limiting their ability to grow and / or spread. Other examples of diseases or conditions from which vascular occlusion may benefit include, but are not limited to, hemorrhage, aneurysm, venous insufficiency, cutting off blood flow before organ removal, or preventing the backflow of embolic microspheres into branch vessels in the liver. This document discloses medical devices that can be used within a part of the cardiovascular system to treat and / or repair certain AVMs and / or other diseases or conditions. The devices disclosed herein may also provide several additional desired features and benefits, as described in more detail below.

[0083] Figure 1 This is a perspective view of an example medical device system 100 in a partially unassembled configuration. The medical device system 100 may include an actuation wire 102 and an implant 104 (see example...). Figure 9 Implants such as, but not limited to, embolization coils, introducer sheaths 106, and locking elements 108. For simplicity, implant 104 is described as an embolization coil, but other suitable medical devices that can be transported, delivered, used, released, etc., in a similar manner are also contemplated, including but not limited to vascular occlusion device coils, stents, embolization filters, replacement heart valves, other occlusion devices, and / or other medical implants.

[0084] Embolization coil 104 can typically be introduced into a blood vessel using a microcatheter (not explicitly shown) extending from a proximal point outside the patient's body to a distal point near the embolization site. An introducer sheath 106 containing coil 104 can be used to carry and protect coil 104 prior to insertion into the patient's body. Furthermore, introducer sheath 106 can be used to transfer the coil to the microcatheter and / or assist in coil deployment at a selected embolization site. Sheath 106 can be configured to protect implant 104 and hold implant 104 in a deliverable orientation until implant 104 is deployed. As will be described in more detail herein, locking element 108 can be configured to restrict movement (e.g., axial and rotational) of push wire 102 and implant 104 within sheath 106 until the user is ready to push implant 104 out of sheath 106.

[0085] The sheath 106 may be a tubular member comprising a proximal end 112, a distal end 114, and an intermediate region 116 positioned therebetween. Suitable, but not limiting, materials for the sheath 106 are described below, such as polymeric materials, composite materials, etc. The sheath 106 may define a cavity 110 extending from the proximal end 112 to the distal end 114. The push wire 102 and the implant 104 are slidably disposed within the cavity 110 of the sheath 106 such that the push wire 102 and the implant 104 are radially inward of the sheath 106. The implant 104 may be disposed adjacent to the distal end 114 of the sheath 106. The push wire 102 may slide axially between an interlocked position and a release position. The push wire 102 may be configured to be releasably attached to the implant 104. The implant 104 may be configured to expand from a delivery configuration to an unfolded configuration. The push wire 102 may typically be a solid wire or a spool, but in some embodiments it may also be tubular. The following describes some suitable, but not limiting, materials for the actuating wire 102, such as metallic materials, polymeric materials, composite materials, etc. As will be described in more detail herein, the actuating wire 102 can be releasably secured to the sheath 106 via locking element 108 to restrict axial and / or rotational movement of the actuating wire 102 within the sheath 106.

[0086] The sheath 106 may have a first slot 118a and a second slot 118b (collectively referred to as 118) extending distally from the proximal end 112. The first and second slots 118a, 118b may be positioned opposite to another or spaced approximately 180° around the circumference of the sheath 106. Although the sheath 106 is described as having two slots, the sheath 106 may also include fewer or more than two slots as needed. The slots 118 may extend less than the entire length of the sheath 106. The slots 118 can remove material from the sheath 106 to create flexible arms or components 120a, 120b (collectively referred to as 120). Although the sheath 106 is described as having two arms 120, it should be understood that the number of flexible arms may vary with the number of slots 118, and there may be fewer or more than two flexible arms as needed. Furthermore, the slots 118 may be evenly or eccentrically distributed around the circumference of the sheath 106. The length and / or dimensions of the slot 118 (and / or arm 120) can be varied to produce different degrees of wedging (between the locking element 108 and the actuating wire 102) and locking capability. It is conceivable that the proximal region 129 of the sheath 106 may be formed of polypropylene or a similar material. The stiffness of the proximal region 129 can be manipulated to produce the desired locking effect. In some cases, other portions of the sheath 106 may be formed of the same material as the proximal region 129, while in others, other portions of the sheath 106 may be formed of a different material. For example, the sheath 106 may include a distal polyimide tip (however, this is not required).

[0087] For further reference Figure 2 The diagram shows a perspective view of a locking element 108, which may be a tubular member having a proximal end 122, a distal end 124, and an intermediate region 126 located therebetween. The locking element 108 may have a generally constant or uniform outer diameter 130 on a proximal region 128 extending from the proximal end 122 toward and into the intermediate region 126. The locking element 108 may include a distal region 132 comprising a plurality of raised regions or circumferential ribs 136a, 136b, 136c, 136d (collectively referred to as 136). The circumferential ribs 136 may have an outer diameter 134 larger than the outer diameter 130 of the proximal region 128. It is conceivable that the circumferential ribs 136 may increase the tactile feel of the locking element 108 and / or make the locking element 108 easier to grip or handle. The number of circumferential ribs 136 (e.g., fewer than four or more than four), the size of the circumferential ribs 136 (e.g., increasing or decreasing the diameter 134), the geometry of the circumferential ribs 136 (extending approximately less than the entire circumference, having a different shape, etc.), the positioning of the circumferential ribs 136 along the length of the locking element 108, and / or the spacing of the circumferential ribs 136 may be changed as needed to enhance or reduce the tactile or grip properties of the locking element 108.

[0088] Locking element 108 may define a cavity 135 extending from proximal end 122 to distal end 124. As will be discussed in more detail herein, a portion of the cavity 135 of locking element 108 may be sized to slide freely on sheath 106, while another portion of the cavity 135 may be sized to apply a radially inward compressive force to sheath 106, as will be described in more detail herein. Thus, in some configurations, at least a portion of sheath 106 may be radially inward of locking element 108.

[0089] The locking element 108 can be formed in a variety of different ways. For example, the locking element 108 can be injection molded, heat-shrinkable, 3D printed, etc. The locking element 108 can be formed from a variety of different materials, such as, but not limited to, rigid or soft polymers, metals, composite materials, etc.

[0090] Figure 3 Is Figure 2A cross-sectional view of the locking element 108 taken at line 3-3. The locking element 108 may have a variable inner diameter. For example, in some embodiments, the locking element 108 may have an inner diameter that increases at an angle along a first length 140 from a first inner diameter 137 adjacent to the proximal end 122 to a second inner diameter 138 in a distal direction. In some embodiments, the first length 140 may be substantially the same as the length of the arm 120 of the sheath 106, but this is not required. The second inner diameter 138 may be substantially constant or uniform along a second length 142 of the locking element 108. In some cases, although not explicitly shown, the transition from the first inner diameter 137 to the second inner diameter 138 may be abrupt or gradual. The first length 140 and / or the second length 142 may be varied as needed. Furthermore, the slope of the first length 140 may be varied as needed. The dimensions of the tapered first length 140 and / or second length 142 (e.g., inner diameter, outer diameter, length, slope, etc.) can be varied to create the desired locking effect (described in more detail herein).

[0091] In some embodiments, the wall thickness of the locking element 108 may vary inversely to the inner diameter along a first length 140, while the outer diameter 130 remains constant to vary the inner diameter. For example, the locking element 108 may have a wall thickness 144 near the proximal end 122. The wall thickness may gradually decrease to a second wall thickness 146 at or near the second length 142. In other embodiments, the wall thickness may remain constant. In this case, the inner and outer diameters of the locking element 108 may vary along the first length 140 (e.g., they may be inclined in a similar manner). For example, as the inner diameter increases, the outer diameter of the locking element 108 may increase from the proximal end 122 along the first length 140.

[0092] The larger second inner diameter 138 can be configured to allow the locking element 108 to slide freely on the sheath 106. The smaller first inner diameter 137 can be configured to apply a compressive force or a radially inward force to the outer surface of the sheath 106, as will be described in more detail herein.

[0093] It is conceivable that the construction of locking element 108 can be adjusted to create the desired effect. For example, one or more of the inner diameters 137, 138 can be manufactured larger or smaller to accommodate different sizes of sheath 106 and / or different outer diameters of actuating wire 102. Furthermore, the first and / or second lengths 140, 142 can be longer, shorter, at smaller angles, at larger angles, etc. In another example, the outer diameter of locking element 108 can be increased or decreased to facilitate handling. It is also conceivable that the outer surface of locking element 108 may include features other than or replacing circumferential ribs 136 to improve ergonomic handling, such as, but not limited to, protrusions, waves, textures, or notches to improve grip. In some cases, sheath 106 and / or locking element 108 may include visual markings to guide the user in manipulating locking element 108. In some cases, the overall length of locking element 108 can be increased or decreased as needed. It is also conceivable that locking element 108 can be large enough to be easily handled, but not so large as to be incompatible with other components, such as, but not limited to, packaging.

[0094] Figure 4 A perspective view of another illustrative locking element 200 is shown. Locking element 200 may be similar in form and function to the illustrative locking mechanism 108 described herein and may be used with a medical device system, such as the medical device system 100 described herein. Locking element 200 may be a tubular member having a proximal end 202, a distal end 204, and an intermediate region 206 located therebetween. Locking element 200 may have a generally constant or uniform outer diameter 210 extending from the proximal end 202 to the distal end 204, but this is not required. Locking element 200 may define a cavity 212 extending from the proximal end 202 to the distal end 204. As will be discussed in more detail herein, a portion of the cavity 212 of locking element 200 may be sized to slide freely on a sheath, such as the sheath 106 described herein, while another portion of the cavity 212 may be sized to apply a radially inward force or compressive force to the sheath 106, as will be described in more detail herein. Therefore, in some configurations, at least a portion of the sheath 106 may be radially inside the locking element 200.

[0095] The locking element 200 can be formed in a variety of different ways. For example, the locking element 200 can be injection molded, heat-shrinkable, 3D printed, etc. The locking element 200 can be formed from a variety of different materials, such as, but not limited to, rigid or soft polymers, metals, composite materials, etc.

[0096] Figure 5 Is Figure 4A cross-sectional view of the locking element 200 taken at line 5-5. The locking element 200 may have a variable inner diameter. For example, in some embodiments, the locking element 200 may have an inner diameter that increases at an angle along a first length 214 from a first inner diameter 216 adjacent to the proximal end 202 to a second inner diameter 218 in a distal direction. In some embodiments, the first length 214 may be substantially the same as the length of the arm 120 of the sheath 106, but this is not required. The second inner diameter 218 may be substantially constant or uniform along a second length 220 of the locking element 200. In some cases, although not explicitly shown, the transition from the first inner diameter 216 to the second inner diameter 218 may be abrupt or gradual. The first length 214 and / or the second length 220 may be varied as needed. Furthermore, the slope of the first length 214 may be varied as needed. The dimensions of the tapered first length 214 and / or second length 220 (e.g., inner diameter, outer diameter, length, slope, etc.) can be varied to create the desired locking effect (described in more detail herein).

[0097] In some embodiments, the wall thickness of the locking element 200 may vary inversely to the inner diameter along a first length 214, while the outer diameter 210 remains constant to vary the inner diameter. For example, the locking element 200 may have a first wall thickness 222 near the proximal end 202. The wall thickness may gradually decrease to a second wall thickness 224 at or near the second length 220. In other embodiments, the wall thickness may remain constant. In this case, the inner and outer diameters of the locking element 200 may vary along the first length 214 (e.g., they may be inclined in a similar manner). For example, as the inner diameter increases, the outer diameter of the locking element 200 may increase from the proximal end 202 along the first length 214.

[0098] The larger second inner diameter 218 can be configured to allow the locking element 200 to slide freely on the sheath 106. The smaller first inner diameter 216 can be configured to apply a compressive force or a radially inward force to the outer surface of the sheath 106, as will be described in more detail herein.

[0099] It is conceivable that the construction of the locking element 200 can be adjusted to create the desired effect. For example, one or more of the inner diameters 216, 218 can be manufactured larger or smaller to accommodate different sizes of the sheath 106. Furthermore, the first and / or second lengths 214, 220 can be longer, shorter, at smaller angles, at larger angles, etc. In another example, the outer diameter of the locking element 200 can be increased or decreased to facilitate handling. It is also conceivable that the outer surface of the locking element 200 may include features to improve ergonomic handling, such as, but not limited to, protrusions, waves, textures, or notches to improve grip. In some cases, the sheath 106 and / or the locking element 200 may include visual markings to guide the user in manipulating the locking element 200. In some cases, the overall length of the locking element 200 can be increased or decreased as needed. It is also conceivable that the locking element 200 can be large enough to be easily handled, but not so large as to be incompatible with other components, such as, but not limited to, packaging.

[0100] Figure 6 A perspective view of another illustrative locking element 300 is shown. Locking element 300 may be similar in form and function to the illustrative locking mechanism 108 described herein and may be used with a medical device system, such as the medical device system 100 described herein. Locking element 300 may be a tubular member having a proximal end 302, a distal end 304, and an intermediate region 305 positioned therebetween. Locking element 300 may define a cavity 312 extending from the proximal end 302 to the distal end 304. As will be discussed in more detail herein, a portion of the cavity 312 of locking element 300 may be sized to slide freely on a sheath, such as the sheath 106 described herein, while another portion of the cavity 312 may be sized to apply a radially inward force or compressive force to the sheath 106, as will be described in more detail herein. Thus, in some configurations, at least a portion of the sheath 106 may be radially inward of locking element 300. Locking element 300 may also include a slot 310 extending from the proximal end 302 to the distal end 304. The slot 310 may extend through the thickness of the sidewall of the locking element 300 (e.g., from its outer surface to its inner surface). The slot 310 may have a width 314 that is greater than the width of the actuating wire (e.g., such as actuating wire 102 described herein), but smaller than the width of the sheath 106. This allows the locking element 300 to be more easily removed from the medical device system 100, as will be described in more detail herein.

[0101] The locking element 300 may have a tapered or sloping outer diameter on a proximal region 328 extending from the proximal end 302 toward and into the intermediate region 305. The locking element 300 may include a distal region 330 comprising a plurality of raised regions or circumferential ribs 332a, 332b, 332c, 332d (collectively referred to as 332). The circumferential ribs 332 may have an outer diameter 334 larger than the outer diameters 324 and 326 of the proximal region 328. The circumferential ribs 332 may extend around the entire periphery of the locking element 300, which may be less than 360° due to the slot 310. It is conceivable that the circumferential ribs 332 may increase the tactile feel of the locking element 300 and / or make the locking element 300 easier to grip or handle. The number of circumferential ribs 332 (e.g., fewer than four or more than four), the size of the circumferential ribs 332 (e.g., increasing or decreasing the diameter 334), the geometry of the circumferential ribs 332 (extending approximately less than the entire perimeter, having a different shape, etc.), and / or the spacing of the circumferential ribs 332 can be changed as needed to enhance or reduce the tactile or gripping feel of the locking element 300.

[0102] The locking element 300 can be formed in a variety of different ways. For example, the locking element 300 can be injection molded, heat-shrinkable, 3D printed, etc. The locking element 300 can be formed from a variety of different materials, such as, but not limited to, rigid or soft polymers, metals, composite materials, etc.

[0103] Figure 7 Is Figure 6 A cross-sectional view of the locking element 300 taken at line 7-7. The locking element 300 may have a variable outer diameter and a variable inner diameter. For example, in some embodiments, the locking element 300 may have an inner diameter that increases at an angle along a first length 316 from a first inner diameter 318 adjacent to the proximal end 302 to a second inner diameter 320 in a distal direction. In some embodiments, the first length 316 may be substantially the same as the length of the arm 120 of the sheath 106, but this is not required. The second inner diameter 320 may be substantially constant or uniform along a second length 322 of the locking element 300. In some cases, although not explicitly shown, the transition from the first inner diameter 318 to the second inner diameter 320 may be abrupt or gradual. The first length 316 and / or the second length 322 may be varied as needed. Furthermore, the slope of the first length 316 may be varied as needed. A larger second inner diameter 320 may be sized such that the locking element 300 can slide freely on the sheath 106. The smaller first inner diameter 318 can be configured to apply a compressive force or a radially inward force to the outer surface of the sheath 106, as will be described in more detail herein.

[0104] In some embodiments, the wall thickness 336 of the locking element 300 may remain substantially uniform along the first and / or second lengths 316, 322 of the locking element 300. In this case, the inner and outer diameters of the locking element 300 may vary along the first length 316 (e.g., they may be inclined in a similar manner). For example, as the inner diameter increases, the outer diameter of the locking element 300 may increase along the first length 316 from a first outer diameter 324 at the proximal end 302 to a second outer diameter 326 (greater than the first outer diameter 324). In some embodiments, the wall thickness 336 may vary along the first and / or second lengths 316, 322 of the locking element 300. For example, when the circumferential rib 332 is provided, the wall thickness adjacent to the rib 332 may be greater than the wall thickness 336 of other portions of the locking element 300. In other embodiments, the wall thickness 336 may vary to change the diameter of the cavity 310.

[0105] It is conceivable that the construction of the locking element 300 can be adjusted to create the desired effect. The dimensions (e.g., inner diameter, outer diameter, length, slope, etc.) of the tapered first length 316 and / or second length 322 can be varied to create the desired locking effect (described in more detail herein). For example, one or more of the inner diameters 318, 320 can be manufactured larger or smaller to accommodate different sizes of the sheath 106. Furthermore, the first and / or second lengths 316, 322 can be longer, shorter, at smaller angles, at larger angles, etc. In another example, the outer diameter of the locking element 300 can be increased or decreased to facilitate handling. It is also conceivable that the outer surface of the locking element 300 may include features to improve ergonomic handling, such as, but not limited to, protrusions, waves, textures, or notches to improve grip. In some cases, the sheath 106 and / or the locking element 300 may include visual markings to guide the user in manipulating the locking element 300. In some cases, the overall length of the locking element 300 can be increased or decreased as needed. It is also conceivable that the locking element 300 could be large enough to be easily handled, but not so large as to be incompatible with other components, such as, but not limited to, packaging.

[0106] Figure 8 This is a perspective view of the illustrative medical device system 100 in its unlocked or first assembled form. Figure 9 Is Figure 9 A partial cross-sectional view of the illustrative medical device system 100, taken at line 9-9. While the medical device system 100 is described with respect to a specific locking element 108, it should be understood that locking elements described herein, including but not limited to any of locking elements 200, 300, 408, 508, 600, 708, and 800, may replace locking element 108. Figure 1Starting with the partially unassembled configuration, to position the locking element 108 so that it can be used to secure the actuating wire 102, the locking element 108 is advanced from the proximal end 112 to the distal end on the proximal region 129 of the sheath 106. In the first assembled configuration, the locking element 108 may not be entirely disposed on the sheath 106. For example, the first length 140 of the locking element 108, having a reduced inner diameter, may be partially disposed on the sheath 106 or not disposed at all. In this configuration, the actuating wire 102 is free to slide axially (e.g., proximal and distal) and / or rotate within the cavity 110 of the sheath 106. As described above, the inner diameter of the sheath 106 may remain constant or substantially constant from the proximal end 112 to the distal end 114.

[0107] In order to further advance the locking element 108 in a distal direction relative to the locking push wire 102 relative to the sheath 106 until the first length 140 of the locking element 108 is positioned on the arm 120 of the sheath 106. Figure 10 This is a perspective view of an illustrative medical device system 100 in its locked or second assembly configuration. Figure 11 Is Figure 10 A partial cross-sectional view of the illustrative medical device system 100, taken at line 11-11. As described above, portions of the distal portion 132 and proximal portion 128 of the locking element 108 can slide freely on the proximal region 129 of the sheath. When the proximal portion 128 with the decreasing diameter of the locking element 108 reaches the outer sheath 106, the arm 120 of the sheath 106 can be pressed against the outer surface of the actuating wire 102. For example, the locking element 108 can slide freely on the outer sheath 106 until the inner diameter of the locking element 108 is approximately equal to or smaller than the outer diameter of the sheath 106. It is conceivable that the thickness of the outer sheath 106 and the outer diameter of the actuating wire 102 can jointly affect how much the sheath arm 120 collapses before locking onto the actuating wire 102. Once the inner diameter of the locking element 108 begins to frictionally engage the outer surface of the sheath 106, more force may be required to continue the distal movement of the locking element 108. As the locking element 108 is further advanced distally onto the sheath 106, the tapered region (e.g., the first length 140) serves to deflect the arm 120 of the sheath 106 inward and onto the wire 102. When advanced sufficiently, the locking element 108 wedges into the appropriate position, thereby creating the desired locking effect between the sheath 106 and the push wire 102. For example, the tapered portion of the cavity 135 of the locking element 108 can be used as a wedge to press or apply a radially inward biasing force on the outer surface of the arm 120 of the sheath 106, such that the outer diameter of the arm 120 decreases and the inner diameter of the arm is radially biased inward, as... Figure 11 As shown, when the inner diameter of arm 120 decreases, the inner surface of arm 120 contacts and frictionally engages the outer surface of push wire 102.

[0108] exist Figure 10 and Figure 11 In the illustrated locking configuration, the frictional engagement between the inner surface of the sheath 106 and the outer surface of the actuating wire 102 can prevent or inhibit axial (e.g., proximal and distal) and / or rotational movement of the actuating wire 102 within the cavity 110 of the sheath 106. In some embodiments, the arm 120 is configured to facilitate its inward deflection. For example, a cutting pattern of the slot 118 can be applied to facilitate the collapse of the arm 120 and create localized friction points between the inner surface of the sheath 106 (e.g., the inner surface of the arm 120) and the actuating wire 102.

[0109] It is conceivable that a gradual decrease in the inner diameter of the locking element 108 can facilitate its positioning on the sheath 106. For example, the inner diameter 138 of the locking element 108 in the distal portion 132 (and / or a portion of the proximal portion 128) can be large enough to freely pass over the outer diameter of the sheath 106. As the inner diameter of the locking element tapers (e.g., in the proximal direction toward the proximal end 122) to a size smaller than the outer diameter of the sheath 106 and advances sufficiently distally on the sheath 106, it promotes the collapse of the arm 120. This creates a frictional lock between the sheath 106 and the actuating wire 102 as the actuating wire 102 is positioned through the sheath 106.

[0110] When the user is ready to advance the implant 104, the locking element 108 can be removed proximally from the proximal region 129 of the sheath 106. This allows the inner diameter of the sheath 106 adjacent to the arm 120 to expand to its original shape, thereby removing friction locking and allowing the push wire 102 to move freely. Therefore, when the sheath 106 is removed from the push wire 102 and / or the push wire 102 is advanced distally, the sheath 106 will not engage or snag on any part of the push wire 102.

[0111] It is conceivable that when the locking element 108 is provided with a longitudinally extending slot, such as slot 310 shown in locking element 300, the locking element 108 can freely disengage from the actuating wire 102 (e.g., via the slot) without having to retract proximally along the entire length of the actuating wire 102 near the sheath 106. Similarly, during manufacturing, when loading the locking element 108, the locking element 108 can be positioned on the actuating wire 102, rather than having the locking element 108 pass through the actuating wire 102. As mentioned above regarding Figure 6 and Figure 7 As described above, if provided in this way, the dimensions of the longitudinal slot can be set such that the push wire 102 can be fitted through the slot, rather than the sheath 106. This ensures that the locking element 108 is in the locked position (e.g., Figure 10 and Figure 11It will not fall off the sheath 106, but once the locking element is in the unlocked state, it can be easily removed from the push wire 102.

[0112] It is also conceivable that the locking element 108 may be formed of a material that is more rigid or harder than the outer sheath 106. For example, the material for the locking element 108 may be selected such that the locking element 108 does not deflect as the tapered portion of the cavity 135 of the locking element 108 advances onto the sheath 106, but instead forces the sheath 106 to deflect inward. In some embodiments, the locking element 108 may be formed of a bright (or other) color that is easily noticeable to the user.

[0113] Figure 12 This is a perspective view of another illustrative medical device system 400 in a partially unassembled state. Figure 13 Is Figure 12 A cross-sectional view of an illustrative medical device system 400 taken at line 13-13. The medical device system 400 may include an actuating wire 402, an implant (not explicitly shown), such as, but not limited to, an embolization coil, an introducer sheath 406, and a locking element 408. For simplicity, the implant is described as an embolization coil, but other suitable medical devices that can be transported, delivered, used, released, etc., in a similar manner are also contemplated, including but not limited to vascular occlusion device coils, stents, embolization filters, replacement heart valves, other occlusion devices, and / or other medical implants.

[0114] Embolization coils are typically introduced into a blood vessel using a microcatheter (not explicitly shown) extending from a proximal point outside the patient's body to a distal point near the embolization site. An introducer sheath 406 containing the coil can be used to carry and protect the coil before insertion into the patient. Furthermore, the introducer sheath 406 can be used to transfer the coil to the microcatheter and / or assist in coil deployment at a selected embolization site. The sheath 406 can be configured to protect the implant and hold it in a deliverable orientation until deployment. As will be described in more detail herein, a locking element 408 can be configured to restrict movement (e.g., axial and rotational) of the push wire 402 and the implant within the sheath 406 until the user is ready to push the implant out of the sheath 406.

[0115] The sheath 406 may be a tubular member including a proximal end 412, a distal end 414, and an intermediate region 415 positioned therebetween. Suitable, but not limiting, materials for the sheath 406 are described below, such as polymeric materials, composite materials, etc. The sheath 406 may define a cavity 410 extending from the proximal end 412 to the distal end 414. The push wire 402 and the implant are slidably disposed within the cavity 410 of the sheath 406 such that the push wire 402 and the implant are radially inward of the sheath 406. The implant may be disposed adjacent to the distal end 414 of the sheath 406. The push wire 402 may slide axially between an interlocked position and a release position. The push wire 402 may be configured to be releasably attached to the implant. The implant may be configured to expand from a delivery configuration to a deployment configuration. The push wire 402 may typically be a solid wire or a spool, but in some embodiments it may also be tubular. The following describes some suitable, but not limiting, materials for the actuating wire 402, such as metallic materials, polymeric materials, composite materials, etc. As will be described in more detail herein, the actuating wire 402 can be releasably secured to the sheath 406 via locking element 408 to restrict axial and / or rotational movement of the actuating wire 402 within the sheath 406.

[0116] The sheath 406 may have a longitudinally extending slot 416 extending distally from the proximal end 412. The slot 416 may terminate at a circumferentially extending "C"-shaped cutout 418 around the sheath 416. The cutout 418 may be positioned in a plane generally perpendicular to the longitudinal axis of the sheath 406. In some cases, the cutout 418 may extend less than 360°, less than 270°, less than 180°, less than 135°, or less than 90° around the circumference of the sheath 406 as needed. It is conceivable that the radial length of the cutout 418 may vary to produce a desired locking effect. Similarly, the length and width of the slot 416 may vary to produce a desired locking effect. The slot 416 and the cutout 418 may allow the free edges or flaps 420a, 420b (collectively referred to as 420) of the sheath 406 to fold or collapse when a radially inward force is applied to their outer surfaces to create a frictional lock, as will be described in more detail herein.

[0117] It is conceivable that the proximal region 422 of the sheath 406 may be formed of polypropylene or a similar material. The stiffness of the proximal region 422 can be manipulated to produce a desired locking effect. In some cases, other portions of the sheath 406 may be formed of the same material as the proximal region 422, while in other cases, other portions of the sheath 406 may be formed of a different material than the proximal region 422. For example, the sheath 406 may include a distal polyimide tip (however, this is not necessary).

[0118] For further reference Figure 14The diagram shows a perspective view of a locking element 408, which may be a tubular member having a proximal end 424, a distal end 426, and an intermediate region 428 located therebetween. The locking element 408 may have a substantially constant or uniform outer diameter 430 over the intermediate region 428. The outer diameter may increase from the intermediate region 428 in both the proximal and distal directions to create a flared proximal portion 432 and a flared distal portion 434. The diameter of the flared proximal portion 432 may increase toward the proximal end 424 to a second outer diameter 436 larger than the first outer diameter 430 adjacent to the intermediate region 428. Similarly, the diameter of the flared distal portion 434 may increase toward the distal end 426 to a second outer diameter 436 larger than the first outer diameter 430 adjacent to the intermediate region 428.

[0119] Locking element 408 may define a cavity 438 extending from proximal end 424 to distal end 426. As will be discussed in more detail herein, a portion of the cavity 438 of locking element 408 may be sized to slide freely on sheath 406, while another portion of the cavity 438 may be sized to apply a radially inward compressive force to sheath 406, as will be described in more detail herein. Thus, in some configurations, at least a portion of sheath 406 may be radially inward of locking element 408.

[0120] The locking element 408 can be formed in a variety of different ways. For example, the locking element 408 can be injection molded, heat-shrinkable, 3D printed, etc. The locking element 408 can be formed from a variety of different materials, such as, but not limited to, rigid or soft polymers, metals, composite materials, etc.

[0121] Figure 15 Is Figure 14A cross-sectional view of the locking element 408 taken at line 15-15. The locking element 408 may have a variable inner diameter. In some cases, the cavity 438 may have a generally hourglass shape. For example, in some embodiments, the locking element 408 may have an inner diameter 440 adjacent to its proximal and distal ends 424, 426. The first inner diameter 440 may be tapered or inclined toward a second generally constant inner diameter 442. It is conceivable that the inclined inner diameter may generally correspond to the proximal and distal portions 432, 434 of the flare, while the generally constant inner diameter 442 may generally correspond to the middle region 428. However, this is not necessary. However, in such an arrangement, the locking element 408 may have a generally uniform wall thickness from its proximal end 424 to its distal end 426. In other embodiments, the inner diameter of the locking element 408 may be varied by varying the wall thickness of the locking element 408 along its length. Furthermore, in some cases, although not explicitly shown, the transition from the first inner diameter 440 to the second inner diameter 442 can be abrupt or gradual. The dimensions (e.g., inner diameter, outer diameter, length, slope, etc.) of the proximal portion 432 of the flare, the distal portion 434 of the flare, and / or the intermediate region 428 can be varied to create the desired locking effect (described in more detail herein).

[0122] The larger first inner diameter 440 can be configured to allow the locking element 408 to slide freely on the sheath 406. The smaller first inner diameter 442 can be configured to apply a compressive force or a radially inward force to the outer surface of the sheath 406, as will be described in more detail herein.

[0123] It is conceivable that the construction of locking element 408 can be adjusted to create the desired effect. For example, one or more of the inner diameters 440, 442 can be manufactured larger or smaller to accommodate different sizes of sheath 406. Furthermore, the proximal portion 432 of the flare, the distal portion 434 of the flare, and / or the intermediate region 428 can be longer, shorter, at smaller angles, at larger angles, etc. In another example, the outer diameter of locking element 408 can be increased or decreased to facilitate handling. It is also conceivable that the outer surface of locking element 408 can include features to improve ergonomic handling, such as, but not limited to, protrusions, waves, textures, or notches to improve grip. In some cases, sheath 406 and / or locking element 408 can include visual markings to guide the user in manipulating locking element 408. In some cases, the overall length of locking element 408 can be increased or decreased as needed. It is also conceivable that locking element 408 can be large enough to be easily handled, but not so large as to be incompatible with other components, such as, but not limited to, packaging.

[0124] Figure 16 This is a perspective view of an illustrative medical device system 400 in its locked state. Figure 17A Is Figure 16 A partial cross-sectional view of the illustrative medical device system 400, taken along lines 17A-17A. While the medical device system 400 is described with respect to a specific locking element 408, it should be understood that any locking element described herein, including but not limited to any of locking elements 108, 200, 300, 508, 600, 708, and 800, may replace locking element 408. Figure 12 Starting with the partially unassembled configuration shown, in order to position the locking element 408 so that it can be used to fix the push wire 402, the locking element 408 is advanced from the proximal end 412 to the distal end on the proximal region 422 of the sheath 406.

[0125] To lock the push wire 402 relative to the sheath 406, the locking element 408 is further advanced in a distal direction until the intermediate region 428 of the locking element 408 is positioned on the flap 420 of the sheath 406. The distal portion 432 of the flared locking element 408 can slide freely on the proximal region 422 of the sheath. When the intermediate region 428 with the reduced diameter 442 of the locking element 408 reaches the outer sheath 406, the flap 420 of the sheath 406 can fold and be pressed against the outer surface of the push wire 402. Figure 17B This situation is illustrated more clearly in the text. Figure 17B Is Figure 17A A partial cross-sectional view of an illustrative medical device system 400, taken along lines 17B-17B. For example, the locking element 408 can slide freely on the outer sheath 406 until the inner diameter of the locking element 408 is approximately equal to or smaller than the outer diameter of the sheath 406. Once the inner diameter of the locking element 408 begins to frictionally engage the outer surface of the sheath 406, more force may be required to continue the distal movement of the locking element 408. As the locking element 408 is further advanced distally onto the sheath 406, the intermediate region 428 serves to deflect the flaps 420 of the sheath 406 inward and onto the wire 402. In some cases, the tapered cavity of the flared distal portion 434 can gradually deflect the flaps 420 inward. When advanced sufficiently, the locking element 408 wedges into the appropriate position, thereby creating the desired locking effect between the sheath 406 and the actuating wire 402. For example, the reduced-diameter portion of the cavity 438 of the locking element 408 (e.g., having a smaller second inner diameter 442) can be used as a wedge to press against or apply a radially inward biasing force on the outer surface of the flap 420 of the sheath 406, such that the outer diameter of the flap 420 is reduced and the inner diameter of the arm is radially biased inward, as... Figure 17B As shown, when the inner diameter of the vane 420 decreases, the inner surface of the vane 420 contacts and frictionally engages with the outer surface of the push wire 402.

[0126] exist Figure 16 , Figure 17A and Figure 17B In the illustrated locking configuration, the frictional engagement between the inner surface of the sheath 406 and the outer surface of the actuating wire 402 can prevent or inhibit axial (e.g., proximal and distal) and / or rotational movement of the actuating wire 402 within the cavity 410 of the sheath 406. In some embodiments, the flap 420 is configured to facilitate its inward deflection. For example, a cutting pattern of slot 416 and / or slit 418 can be applied to facilitate the collapse of the flap 420 and create localized friction points between the inner surface of the sheath 406 (e.g., the inner surface of the flap 420) and the actuating wire 402.

[0127] It is conceivable that a gradual decrease in the inner diameter of the locking element 408 can facilitate its positioning on the sheath 406. For example, the inner diameter 440 of the locking element 408 in the distal portion 434 (and / or a portion of the proximal portion 432) can be large enough to freely pass over the outer diameter of the sheath 406. As the inner diameter of the locking element 408 tapers (e.g., in the proximal direction toward the proximal end 424) to a size smaller than the outer diameter of the sheath 406, and is advanced distally enough on the sheath 406, it facilitates the collapse of the flap 420. This creates a frictional lock between the sheath 406 and the actuating wire 402 as the actuating wire 402 is positioned through the sheath 406.

[0128] When the user is ready to advance the implant, the locking element 408 can be removed proximally from the proximal region 422 of the sheath 406. This allows the inner diameter of the sheath 406 adjacent to the flap 420 to expand to its original shape, thereby removing friction locking and allowing the push wire 402 to move freely. Therefore, when the sheath 406 is removed from the push wire 402, the sheath 406 will not engage or get caught on any part of the push wire 402.

[0129] It is conceivable that when the locking element 408 is provided with a longitudinally extending slot, such as slot 310 shown in locking element 300, the locking element 408 can freely disengage from the actuating wire 402 (e.g., via the slot) without having to retract proximally along the entire length of the actuating wire 402 near the sheath 406. Similarly, during manufacturing, when loading the locking element 408, the locking element 408 can be placed on the actuating wire 402, rather than having the locking element 408 pass through the actuating wire 402. As mentioned above regarding Figure 6 and Figure 7 As described above, if configured in this way, the size of the longitudinal slot can be set such that the push wire 402 can pass through the slot, rather than the sheath 406, for assembly. This ensures that the locking element 408 is in the locked position (e.g., Figure 16 , Figure 17A and Figure 17BIt will not fall off the sheath 406, but once the locking element is in the unlocked state, it can be easily removed from the push wire 402.

[0130] It is also conceivable that the locking element 408 may be formed of a material that is more rigid or harder than the outer sheath 406. For example, the material for the locking element 408 may be chosen such that when the tapered portion of the cavity 438 of the locking element 408 is advanced on the sheath 406, the locking element 408 does not deflect, but instead forces the sheath 406 to deflect inward. In some embodiments, the locking element 408 may be formed of a bright (or other) color that is easily noticeable to the user.

[0131] Figure 18 This is a 3D view of the example medical device system 500 in its unlocked assembly configuration. Figure 19 Is Figure 18 The image shows a partial cross-sectional view of the medical device system 500 taken at line 19-19. The medical device system 500 may include an actuating wire 502, an implant (not explicitly shown), such as, but not limited to, an embolization coil, an introducer sheath 506, and a locking element 508. For simplicity, the implant is described as an embolization coil, but other suitable medical devices for similar transport, delivery, use, release, etc., are also contemplated, including but not limited to vascular occlusion device coils, stents, embolization filters, replacement heart valves, other occlusion devices, and / or other medical implants.

[0132] Embolization coils are typically introduced into a blood vessel using a microcatheter (not explicitly shown) extending from a proximal point outside the patient's body to a distal point near the embolization site. An introducer sheath 506 containing the coil can be used to carry and protect the coil before insertion into the patient. Furthermore, the introducer sheath 506 can be used to transfer the coil to the microcatheter and / or assist in coil deployment at a selected embolization site. The sheath 506 can be configured to protect the implant and hold it in a deliverable orientation until deployment. As will be described in more detail herein, a locking element 508 can be configured to restrict movement (e.g., axial and rotational) of the push wire 502 and the implant within the sheath 506 until the user is ready to push the implant out of the sheath 506.

[0133] Sheath 506 may be a tubular member, including a proximal end 512 (e.g., Figure 19The sheath 506 comprises a distal end 514 and an intermediate region 516 positioned between them. Suitable, but not limiting, materials for the sheath 506 are described below, such as polymeric materials, composite materials, etc. The sheath 506 may define a cavity 510 extending from the proximal end 512 to the distal end 514. The push wire 502 and the implant may be slidably disposed within the cavity 510 of the sheath 506 such that the push wire 502 and the implant are radially inward of the sheath 506. The implant may be disposed adjacent to the distal end 514 of the sheath 506. The push wire 502 may slide axially between an interlocked position and a release position. The push wire 502 may be configured to be releasably attached to the implant. The implant may be configured to expand from a delivery configuration to a deployment configuration. The push wire 502 may typically be a solid wire or a spool, but in some embodiments it may also be tubular. Suitable, but not limiting, materials for the push wire 502 are described below, such as metallic materials, polymeric materials, composite materials, etc. As will be described in more detail herein, the push wire 502 can be releasably secured to the sheath 506 via the locking element 508 to restrict axial and / or rotational movement of the push wire 502 within the sheath 506.

[0134] It is conceivable that the proximal region 520 of the sheath 506 may be formed of polypropylene or a similar material. The stiffness of the proximal region 520 can be manipulated to produce a desired locking effect. In some cases, other portions of the sheath 506 may be formed of the same material as the proximal region 520, while in other cases, other portions of the sheath 506 may be formed of a different material than the proximal region 520. For example, the sheath 506 may include a distal polyimide tip (however, this is not necessary).

[0135] For further reference Figure 19The sheath 506 may include an angled protrusion 518 adjacent to the proximal end 512 and extending radially outward from the outer surface of the sheath 506. The angled protrusion 518 may mate with a corresponding protrusion 528 on the locking element 508 to allow the locking element 508 to advance distally on the sheath 506 while providing a mechanical stop that limits actuation of the locking element 508 in the proximal direction. In some cases, the angled protrusion 518 may be a single component extending around the entire circumference (e.g., 360°) of the sheath 506. In other cases, the angled protrusion 518 may be formed by a plurality of individual protrusions spaced apart (uniformly or eccentrically) around the circumference of the sheath 506. The angled protrusion 518 may have an outer diameter that decreases in the proximal direction (e.g., toward the proximal end 512). The distal end of the angled protrusion 518 may be generally planar and have an outer diameter greater than the inner diameter of the proximal end of the protrusion 528 of the locking element 508, as will be described in more detail herein. The distal end of the angled protrusion 518 may extend generally orthogonally to the longitudinal axis of the sheath 506, while the angled surface extends at an angle that is neither orthogonal nor parallel to the longitudinal axis of the sheath 506.

[0136] Locking element 508 may be a tubular member having a proximal end 522, a distal end 524, and an intermediate region 526 positioned therebetween. Locking element 508 may have a tapered or sloping outer diameter on the proximal region 536, which increases from the proximal end 522 toward and into the intermediate region 526. Locking element 508 may include a distal region 538 having a generally uniform or constant outer diameter. Locking element 508 may define a cavity 530 extending from the proximal end 522 to the distal end 524. As will be discussed in more detail herein, a portion of the cavity 530 of locking element 508 may be sized to allow free sliding on a sheath 506, while another portion of the cavity 530 may be sized to apply a radially inward compressive force to the sheath 506, as will be described in more detail herein. Thus, in some configurations, at least a portion of the sheath 506 may be radially inward of locking element 508.

[0137] The locking element 508 can be formed in a variety of different ways. For example, the locking element 508 can be injection molded, heat-shrinkable, 3D printed, etc. The locking element 508 can be formed from a variety of different materials, such as, but not limited to, rigid or soft polymers, metals, composite materials, etc.

[0138] Locking element 508 may have a variable inner diameter. For example, in some embodiments, locking element 508 may have an inner diameter that increases at an angle in the proximal region 536 in a distal direction, from a smaller first inner diameter adjacent to the proximal end 522 to a larger second inner diameter. The second inner diameter 138 may be substantially constant or uniform in the distal region 538 of locking element 508. In some cases, although not explicitly shown, the transition from the first inner diameter to the second inner diameter 138 may be abrupt or gradual. The proximal region 536 and / or the distal region 538 may be varied as needed. Furthermore, the slope of the proximal region 536 may be varied as needed. The dimensions (e.g., inner diameter, outer diameter, length, slope, etc.) of the tapered proximal region 536 and / or the distal region 538 may be varied to create a desired locking effect (described in more detail herein).

[0139] In some embodiments, the wall thickness of the locking element 508 may remain substantially uniform across the proximal and / or distal regions 536, 538 of the locking element 508. In this case, the inner and outer diameters of the locking element 508 may vary along the proximal region 536 (e.g., may be inclined in a similar manner). For example, as the inner diameter increases, the outer diameter of the locking element 508 may increase along the proximal region 536 from a first outer diameter at the proximal end 522 to a second outer diameter (greater than the first outer diameter). In some embodiments, the wall thickness may vary across the proximal and / or distal regions 536, 538 of the locking element 508. The larger second inner diameter may be configured to allow the locking element 508 to slide freely on the sheath 506. The smaller first inner diameter may be configured to apply a compressive force or a radially inward force to the outer surface of the sheath 506, as will be described in more detail herein.

[0140] Locking element 508 may include an angled protrusion 528 adjacent to distal end 524 and extending radially inward from an inner surface of locking element 508. The angled protrusion 528 may mate with a protrusion 518 on sheath 506 to allow distal advancement of locking element 508 on sheath 506 while providing a mechanical stop limiting actuation of locking element 508 in the proximal direction. In some cases, the angled protrusion 528 may be a single component extending over the entire inner surface (e.g., 360°) of cavity 530 of locking element 508. In other cases, the angled protrusion 528 may be formed by a plurality of individual protrusions spaced apart (uniformly or eccentrically) around the inner surface of cavity 530. The angled protrusion 528 may have an inner diameter that decreases in a distal direction (e.g., toward distal end 524). The proximal end of the angled protrusion 528 may be generally planar and have an inner diameter smaller than the outer diameter of the distal end of the protrusion 518 of the sheath 506. The proximal end of the angled protrusion 528 may extend generally orthogonally to the longitudinal axis of the locking element 508, while the angled surface extends at an angle that is not orthogonal and not parallel to the longitudinal axis of the locking element 508.

[0141] The inclined surfaces of the angled protrusions 518, 528 can be configured such that the angled protrusion 518 on the sleeve 506 essentially serves as a ramp for the angled protrusion 528 on the locking element 508. This allows the locking element 508 to be loaded onto the proximal region 520 of the sleeve 506 by advancing the distal end 512 of the sleeve 506 through the distal end 524 of the locking element. Once loaded onto the sleeve 506, retraction of the locking element 508 proximally is restricted. For example, the proximal end of the generally flat plane of the angled protrusion 528 on the locking element 508 will abut the distal end of the generally flat plane of the angled protrusion 518 on the sleeve 506, thereby creating a mechanical stop that restricts axial movement of the locking element 508. This allows the locking element 508 to be locked over a shorter distance (see, for example, Figure 20 It can move between the unlocked and unlocked forms without completely removing it from the push wire 502.

[0142] It is conceivable that the construction of locking element 508 can be adjusted to create the desired effect. For example, one or more of the inner diameters can be manufactured larger or smaller to accommodate different sizes of sheath 506. Furthermore, the proximal and / or distal regions 536, 538 can be longer, shorter, at smaller angles, at larger angles, etc. In another example, the outer diameter of locking element 508 can be increased or decreased to facilitate handling. It is also conceivable that the outer surface of locking element 508 can include features to improve ergonomic handling, such as, but not limited to, protrusions, waves, textures, or notches to improve grip. In some cases, sheath 506 and / or locking element 508 can include visual markings to guide the user in manipulating locking element 508. In some cases, the overall length of locking element 508 can be increased or decreased as needed. It is also conceivable that locking element 508 can be large enough to be easily handled, but not so large as to be incompatible with other components, such as, but not limited to, packaging.

[0143] While the medical device system 500 is described with respect to a specific locking element 508, it should be understood that any of the locking elements described herein can replace locking element 508. To position locking element 508 so that it can be used to secure actuating wire 502, locking element 508 is advanced distally from proximal end 512 on the proximal region 520 of sheath 506. It should be understood that in the unlocked configuration, different lengths of locking element 508 can be positioned on sheath 506. However, in the unlocked configuration, the entire locking element 508 may not be located on sheath 506. For example, the proximal region 536 of locking element 508 with a reduced inner diameter may be only partially located on sheath 506 or not located at all on sheath 506. In this configuration, actuating wire 502 is free to slide axially (e.g., proximal and distally) and / or rotate within the cavity 510 of sheath 506. As described above, the inner diameter of sheath 506 can remain constant or substantially constant from proximal end 512 to distal end 514.

[0144] In order to further advance the locking element 508 in a distal direction relative to the locking push wire 502 relative to the sheath 506, until the proximal region 536 of the locking element 508 is disposed on the proximal region 520 of the sheath 506. Figure 20This is a partial cross-sectional view of the medical device system 500 in its locked configuration. As described above, portions of the distal portion 538 and proximal portion 536 of the locking element 508 can slide freely on the proximal region 520 of the sheath. When the proximal portion 536, with its decreasing diameter, of the locking element 508 reaches the outer sheath 506, the sheath 506 can be pressed against the outer surface of the actuating wire 502. For example, the locking element 508 can slide freely on the outer sheath 506 until the inner diameter of the locking element 508 is approximately equal to or smaller than the outer diameter of the sheath 506. Once the inner diameter of the locking element 508 begins to frictionally engage the outer surface of the sheath 506, more force may be required to continue the distal movement of the locking element 508. As the locking element 508 is further advanced distally onto the sheath 506, the tapered region (e.g., the proximal region 536) serves to deflect the sheath 506 inward and onto the wire 502. When advanced sufficiently, the locking element 508 wedges into the appropriate position, thereby creating the desired locking effect between the sheath 506 and the push wire 502. For example, the tapered portion of the cavity 530 of the locking element 508 can be used as a wedge to press or apply a radially inward biasing force on the outer surface of the sheath 506, causing the outer diameter of the sheath 506 to decrease and the inner diameter of the sheath 506 to be radially biased inward, such as... Figure 20 As shown, when the inner diameter of the sheath 506 decreases, the inner surface of the sheath 506 contacts and frictionally engages with the outer surface of the push wire 502.

[0145] exist Figure 20 In the illustrated locking configuration, the frictional engagement between the inner surface of the sheath 506 and the outer surface of the actuating wire 502 can prevent or inhibit axial (e.g., proximal and distal) and / or rotational movement of the actuating wire 502 within the cavity 510 of the sheath 506. In some embodiments, the sheath 506 may be configured to facilitate its inward deflection. For example, the sheath 506 may include cuts, slots, reduced thickness, greater flexibility, etc., to facilitate the collapse of the sheath 506 and create localized friction points between the inner surface of the sheath 506 and the actuating wire 502.

[0146] It is conceivable that a gradual decrease in the inner diameter of the locking element 508 can facilitate the positioning of the locking element 508 on the sheath 506. For example, the inner diameter of the locking element 508 in the distal portion 538 (and / or a portion of the proximal portion 536) can be large enough to freely pass over the outer diameter of the sheath 506. As the inner diameter of the locking element tapers (e.g., in the proximal direction toward the proximal end 522) to a size smaller than the outer diameter of the sheath 506 and advances distally enough on the sheath 506, it facilitates the collapse of the sheath 506. This creates a frictional lock between the sheath 506 and the actuating wire 502 as the actuating wire 502 is positioned through the sheath 506.

[0147] When the user is ready to advance the implant, the locking element 508 can be displaced (but not completely removed) from the proximal region 520 of the sheath 506. This allows the inner diameter of the sheath 506 to expand to its original shape, thereby eliminating friction locking and allowing the push wire 502 to move freely. Therefore, when the sheath 506 is removed from the push wire 502, the sheath 506 will not engage or get caught on any part of the push wire 502.

[0148] It is conceivable that the locking element 508 may be formed of a material that is more rigid or harder than the outer sheath 506. For example, the material used for the locking element 508 may be selected such that when the tapered portion of the cavity 530 of the locking element 508 is advanced on the sheath 506, the locking element 508 does not deflect, but instead forces the sheath 506 to deflect inward. In some embodiments, the locking element 508 may be formed of a bright (or other) color that is easily noticeable to the user.

[0149] Figure 21 A perspective view of another illustrative locking element 600 is shown. Locking element 600 may be similar in form and function to the illustrative locking mechanism 108 described herein and may be used with a medical device system, such as the medical device system 100 described herein. Locking element 600 may be a tubular member having a proximal end 602, a distal end 604, and an intermediate region 605 positioned therebetween. Locking element 600 may define a cavity 612 extending from the proximal end 602 to the distal end 604. A portion of the cavity 612 of locking element 600 may be sized to slide freely on a sheath, such as the sheath 106 described herein, while another portion of the cavity 612 may be sized to apply a radially inward force or compressive force to the sheath 106, as will be described in more detail herein. Thus, in some configurations, at least a portion of the sheath 106 may be radially inward of locking element 600.

[0150] The locking element 600 may have a tapered or sloping outer diameter on a proximal region 628 extending from the proximal end 602 toward and into the intermediate region 605. Similarly, the locking element 600 may have a tapered or sloping outer diameter on a distal region 630 extending from the distal end 604 toward and into the intermediate region 605. However, in some cases, one or both of the proximal regions 628 and the distal regions 630 may have a substantially constant outer diameter, or the diameter may increase toward the intermediate region 605 as needed. The intermediate region 605 may include a plurality of raised regions or circumferential ribs 632a, 632b, 632c (collectively referred to as 632). The circumferential ribs 632 may have an outer diameter 634 greater than the outer diameter 624 of the intermediate region 605 between the ribs 632. Depending on the need, the circumferential ribs 632 may extend around the entire periphery of the locking element 600 or less than the entire periphery. It is conceivable that the circumferential ribs 632 can increase the tactile feel of the locking element 600 and / or make the locking element 600 easier to grip or handle. The number of circumferential ribs 632 (e.g., fewer than three or more), the size of the circumferential ribs 632 (e.g., increasing or decreasing the diameter 634), the geometry of the circumferential ribs 632 (extending around a smaller than the entire perimeter, having different shapes, etc.), and / or the spacing of the circumferential ribs 632 can be changed as needed to enhance or reduce the tactile feel or grip of the locking element 600.

[0151] The locking element 600 can be formed in a variety of different ways. For example, the locking element 600 can be injection molded, heat-shrinkable, 3D printed, etc. The locking element 600 can be formed from a variety of different materials, such as, but not limited to, rigid or soft polymers, metals, composite materials, etc.

[0152] Figure 22 Is Figure 21 The image shows a cross-sectional view of the locking element 600 taken at line 22-22. The locking element 600 may have a variable outer diameter and a variable inner diameter. For example, in some embodiments, the locking element 600 may have an inner diameter that increases obliquely in a distal direction from a first inner diameter 618 adjacent to the proximal end 602 to a second inner diameter 620 adjacent to the distal end 604. Furthermore, the slope of the inner surface may vary as needed. The larger second inner diameter 620 may be sized such that the distal region 630 of the locking element 600 can slide freely on the sheath 106. The smaller first inner diameter 618 may be sized such that the proximal region 628 is configured to apply a compressive force or a radially inward force on the outer surface of the sheath 106.

[0153] In some embodiments, the wall thickness 636 of the locking element 600 may vary along the length of the locking element 600. In some cases, the wall thickness 636 is not directly related to the inner diameter of the locking element 600. In other cases, the dimension of the wall thickness 636 may decrease as the inner diameter increases. These are merely some examples. The outer diameter of the locking element 600 may decrease from a first outer diameter 624 at the proximal end 602 to a second outer diameter 626 (smaller than the first outer diameter 624) adjacent to the intermediate region 605. The outer diameter of the locking element 600 may decrease from a third outer diameter 636 at the proximal end 602 to a fourth outer diameter 632 (smaller than the third outer diameter 636) adjacent to the intermediate region 605. In some embodiments, the first outer diameter 622 and the third outer diameter 636 may be approximately equal; however, this is not required. Similarly, the second outer diameter 626 and the fourth outer diameter 632 may be approximately equal; however, this is not required.

[0154] It is conceivable that the construction of the locking element 600 can be adjusted to create the desired effect. The dimensions of the tapered inner diameter (e.g., inner diameter, outer diameter, length, slope, etc.) can be varied to create the desired locking effect. For example, one or more of the inner diameters 618, 620 can be manufactured larger or smaller to accommodate different sizes of the sheath 106. In another example, the outer diameter of the locking element 600 can be increased or decreased to facilitate handling. It is also conceivable that the outer surface of the locking element 600 may include features to improve ergonomic handling, such as, but not limited to, protrusions, waves, textures, or notches to improve grip. In some cases, the sheath 106 and / or the locking element 600 may include visual markings to guide the user in manipulating the locking element 600. In some cases, the overall length of the locking element 600 can be increased or decreased as needed. It is also conceivable that the locking element 600 can be large enough to be easily handled, but not so large as to be incompatible with other components, such as, but not limited to, packaging.

[0155] Figure 23 This is a perspective view of another illustrative medical device system 700 in a partially unassembled configuration. The medical device system 700 may include an actuating wire 702, an implant (not explicitly shown), such as, but not limited to, an embolization coil, an introducer sheath 706, and a locking element 708. For simplicity, the implant is described as an embolization coil, but other suitable medical devices for similar transport, delivery, use, release, etc., are also contemplated, including but not limited to vascular occlusion device coils, stents, embolization filters, replacement heart valves, other occlusion devices, and / or other medical implants. While the medical device system 400 is described with respect to a specific locking element 708, it should be understood that any of the locking elements described herein, including but not limited to locking elements 108, 200, 300, 408, 508, 600, and 800, may replace locking element 408.

[0156] Embolization coils are typically introduced into a blood vessel using a microcatheter (not explicitly shown) extending from a proximal point outside the patient's body to a distal point near the embolization site. An introducer sheath 706 containing the coil can be used to carry and protect the coil before insertion into the patient. Furthermore, the introducer sheath 706 can be used to transfer the coil to the microcatheter and / or assist in coil deployment at a selected embolization site. The sheath 706 can be configured to protect the implant and hold it in a deliverable orientation until deployment. As will be described in more detail herein, a locking element 708 can be configured to restrict movement (e.g., axial and rotational) of the push wire 702 and the implant within the sheath 706 until the user is ready to eject the implant from the sheath 706.

[0157] The sheath 706 may be a tubular member including a proximal end 712, a distal end 714, and an intermediate region 716 positioned therebetween. Suitable, but not limiting, materials for the sheath 706 are described below, such as polymeric materials, composite materials, etc. The sheath 706 may define a cavity 710 extending from the proximal end 712 to the distal end 714. An actuating wire 702 and an implant are slidably disposed within the cavity 710 of the sheath 706 such that the actuating wire 702 and the implant are radially inward of the sheath 706. The implant may be disposed adjacent to the distal end 714 of the sheath 706. The actuating wire 702 may slide axially between an interlocked position and a release position. The actuating wire 702 may be configured to be releasably attached to the implant. The implant may be configured to expand from a delivery configuration to an unfolded configuration. The actuating wire 702 may typically be a solid wire or a spool, but in some embodiments it may also be tubular. The following describes some suitable, but not limiting, materials for the actuating wire 702, such as metallic materials, polymeric materials, composite materials, etc. As will be described in more detail herein, the actuating wire 702 can be releasably secured to the sheath 706 via locking element 708 to restrict axial and / or rotational movement of the actuating wire 702 within the sheath 706.

[0158] The sheath 706 may have a first slot 718a and a second slot 718b (collectively referred to as 718) extending distally from the proximal end 712. The first and second slots 718a, 718b may be positioned opposite to another or spaced approximately 180° around the circumference of the sheath 706. Although the sheath 706 is described as having two slots, the sheath 706 may also include fewer or more slots as needed. The slots 718 may extend less than the entire length of the sheath 706. The slots 718 can remove material from the sheath 706 to create flexible arms or components 720a, 720b (collectively referred to as 720). Although the sheath 706 is described as having two arms 720, it should be understood that the number of flexible arms may vary with the number of slots 718, and there may be fewer or more flexible arms as needed. Furthermore, the slots 718 may be evenly or eccentrically distributed around the circumference of the sheath 706. The length and / or dimensions of the slot 718 (and / or arm 720) can be varied to produce different degrees of wedging (between locking element 708 and push wire 702) and locking capability.

[0159] The sheath 706 may also include a raised protrusion 730 extending radially from its outer surface. The raised protrusion 730 may be positioned adjacent to the proximal region 729 of the sheath 706. In some cases, the raised protrusion 730 may extend distally from the proximal end 712 of the sheath 706. However, this is not necessary. The raised protrusion 730 may be a rectangular prism, such as, but not limited to, a ridge or other three-dimensional structure configured to engage with a groove, notch, or recess within the locking element 708, as will be described in more detail herein.

[0160] It is conceivable that the proximal region 729 of the sheath 706 may be formed of polypropylene or a similar material. The stiffness of the proximal region 729 can be manipulated to produce a desired locking effect. In some cases, other portions of the sheath 706 may be formed of the same material as the proximal region 729, while in other cases, other portions of the sheath 706 may be formed of a different material than the proximal region 729. For example, the sheath 706 may include a distal polyimide tip (however, this is not necessary).

[0161] For further reference Figure 24 The diagram shows a perspective view of a locking element 708, which can be a tubular member having a proximal end 722, a distal end 724, and an intermediate region 726 located therebetween. The locking element 708 can have a generally hourglass-shaped outer profile. For example, the outer diameter can generally decrease from the proximal end 722 toward the intermediate region 726 and increase from the intermediate region 726 to the distal end 724. However, this is not necessary. The outer profile of the locking element 708 can take any desired shape.

[0162] Locking element 708 may define a cavity 728 extending from proximal end 722 to distal end 724. As will be discussed in more detail herein, a portion of the cavity 728 of locking element 708 may be sized to slide freely on sheath 706, while another portion of the cavity 728 may be sized to apply a radially inward compressive force to sheath 706, as will be described in more detail herein. Thus, in some configurations, at least a portion of sheath 706 may be radially inward of locking element 708.

[0163] The intermediate region 726 may include multiple raised areas or circumferential ribs 732a, 732b, 732c (collectively referred to as 732). The circumferential ribs 732 may have a diameter 734 larger than the outer diameter 736 of the intermediate region 726 between the ribs 732. The circumferential ribs 732 may extend around the entire periphery of the locking element 708 or less than the entire periphery, as needed. It is conceivable that the circumferential ribs 732 may increase the tactile feel of the locking element 708 and / or make the locking element 708 easier to grip or handle. The number of circumferential ribs 732 (e.g., fewer than three or more), the size of the circumferential ribs 732 (e.g., increasing or decreasing the diameter 734), the geometry of the circumferential ribs 732 (approximately less than the entire periphery, having different shapes, etc.), and / or the spacing of the circumferential ribs 732 may be varied as needed to enhance or reduce the tactile feel or grip of the locking element 708.

[0164] The locking element 708 may also include one or more features to provide visual cues about how the locking element 708 should be assembled with the sheath 706. For example, the feature may be configured to provide a user with an indication of how to align the locking element 708 with the sheath 706, allowing the locking element 708 to slide on the sheath 706. In some cases, this feature may be incorporated into the structure of the locking element 708. For example, in… Figure 24 In the illustrated embodiment, the locking element 706 includes an axially extending (e.g., parallel to the longitudinal axis of the locking element 708) protrusion 738. The protrusion 738 interacts with an internal groove 740 formed in the inner surface of the locking element 708 (see, for example...). Figure 25 and Figure 26 Radial alignment. As will be described in more detail herein, the groove 740 may be configured to align with the protrusion 730 of the raised portion of the sleeve 706 to allow selective assembly of the locking element 708 with the sleeve 706. The raised portion 738 is just one example of a feature that can be used to provide visual cues to the operator. Other features may include visual markings (e.g., arrows, text, etc.) or other structural features on the outer surface of the locking element 708, as needed.

[0165] The locking element 708 can be formed in a variety of different ways. For example, the locking element 708 can be injection molded, heat-shrinkable, 3D printed, etc. The locking element 708 can be formed from a variety of different materials, such as, but not limited to, rigid or soft polymers, metals, composite materials, etc. It is also conceivable that the locking element 708 can be formed from a material that is more rigid or harder than the outer sheath 706. For example, the material used for the locking element 708 can be selected such that when the tapered portion of the cavity 728 of the locking element 708 is advanced on the sheath 706, the locking element 708 does not deflect, but instead forces the sheath 706 to deflect inward. In some embodiments, the locking element 708 can be formed from a bright (or other) color that is easily noticed by the user.

[0166] Figure 25 Is Figure 24 A cross-sectional view of the locking element 708 taken at line 25-25. Figure 26 This is a distal view of the locking element 708. The locking element 708 may have variable inner cross-sectional dimensions. In some cases, the cavity 728 may have a generally tapered shape. For example, in some embodiments, the cavity 728 of the locking element 708 may have a first cross-sectional dimension 742 adjacent to its proximal end 722, which increases in a distal direction to a second cross-sectional dimension 744 larger than the first cross-sectional dimension 742 adjacent to its distal end 724. The cross-sectional dimensions may gradually transition in a tapered or inclined manner. In other embodiments, the cross-sectional dimensions may change abruptly or gradually. These are merely some examples. In some cases, the wall thickness of the locking element 708 may vary over at least a portion of the locking element. However, this is not necessary. The dimensions of the locking element 708 (e.g., inner diameter, outer diameter, length, slope, etc.) may be varied to create a desired locking effect (described in more detail herein). The distal inner cross-sectional dimension 744 may be configured such that the locking element 708 can slide freely on the sheath 706. The smaller proximal internal cross-sectional dimension 742 can be configured to apply a compressive force or a radially inward force to the outer surface of the sheath 706.

[0167] It is conceivable that the construction of the locking element 708 can be adjusted to create the desired effect. For example, one or more of the internal cross-sectional dimensions 742, 744 can be manufactured larger or smaller to accommodate different sizes of the sheath 706. In another example, the outer diameter of the locking element 708 can be increased or decreased to facilitate handling. It is also conceivable that the outer surface of the locking element 708 may include features to improve ergonomic handling, such as, but not limited to, protrusions, waves, textures, or notches to improve grip. In some cases, the sheath 706 and / or the locking element 708 may include visual markings to guide the user in manipulating the locking element 708. In some cases, the overall length of the locking element 708 can be increased or decreased as needed. It is also conceivable that the locking element 708 can be large enough to be easily handled, but not so large as to be incompatible with other components, such as, but not limited to, packaging.

[0168] As described above, the locking element 708 may also include an axially extending (e.g., parallel to the longitudinal axis of the locking element) notch or groove 740. Figure 25 As shown, the groove 740 may have a first depth 746 adjacent to the distal end 724 and a second depth 748 adjacent to the proximal end 722. The second depth 748 is smaller than the first depth 746, such that when the groove 740 is aligned with the protruding portion 730 of the sheath 706, the distal portion of the locking element 708 can slide freely on the sheath 706. When the locking element 708 is advanced distally, the cavity 728 applies a radially inward force or compressive force to the sheath 706.

[0169] The radial protrusion 730 of the sheath 706 and the groove 740 of the locking element 708 together can create an orientation-dependent assembly. For example, the locking element 708 is oriented such that the groove 740 aligns with the radial protrusion 730 of the sheath to allow the locking element 708 to advance distally over the sheath 706. Misalignment of the groove 740 with the radial protrusion 730 can cause interference between the locking element 708 and the sheath 706, which will prevent the sheath 706 from entering the locking element 708 and subsequently locking the push wire 702. This prevents unintended re-engagement of the locking element 708 and the sheath 706 during use of the system 700 if the locking element 708 is not completely removed from the push wire 702. In the absence of the orientation-dependent feature, if the locking element 708 remains suspended on the push wire 702, accidental re-engagement with the sheath 706 and the push wire 702 may occur during the advancement of the push wire 702 through the sheath 706. It is conceivable that, as needed, other orientation-dependent features may be used on the sheath 706 and / or locking element 708.

[0170] Figure 27A perspective view of another exemplary locking element 800 is shown, which may include features configured to orient the locking element 800 relative to sheaths, such as, but not limited to, sheaths 106, 406, 506, 706, 706 described herein. The locking element 800 may be a tubular member having a proximal end 802, a distal end 804, and an intermediate region 806 located therebetween. The locking element 800 may have a generally hourglass-shaped outer profile. For example, the outer diameter may decrease generally from the proximal end 802 toward the intermediate region 806 and increase from the intermediate region 806 toward the distal end 804. However, this is not required. The outer profile of the locking element 800 may take any desired shape.

[0171] Locking element 800 may define a cavity 808 extending from proximal end 802 to distal end 804. A portion of the cavity 808 of locking element 800 may be sized to slide freely on a sheath, while another portion of the cavity 808 may be sized to apply a radially inward compressive force to the sheath. Thus, in some configurations, at least a portion of the sheath 706 may be radially inward of locking element 800.

[0172] The intermediate region 806 may include multiple raised regions or circumferential ribs 810a, 810b, 810c (collectively referred to as 810). The circumferential ribs 810 may have a diameter greater than the outer diameter 814 of the intermediate region 806 between the ribs 810 (see, for example, Figure 28 The outer diameter is 812 (see example, Figure 28 As needed, the circumferential ribs 810 may extend around the entire periphery of the locking element 800 or less than the entire periphery. It is conceivable that the circumferential ribs 810 may increase the tactile feel of the locking element 800 and / or make it easier to grip or handle. The number of circumferential ribs 810 (e.g., fewer than or more than three), the size of the circumferential ribs 810 (e.g., increasing or decreasing the diameter 812), the geometry of the circumferential ribs 810 (approximately less than the entire periphery, having different shapes, etc.), and / or the spacing of the circumferential ribs 810 may be varied as needed to enhance or reduce the tactile feel or grip of the locking element 800.

[0173] The locking element 800 can be formed in a variety of different ways. For example, the locking element 800 can be injection molded, heat-shrinkable, 3D printed, etc. The locking element 800 can be formed from a variety of different materials, such as, but not limited to, rigid or soft polymers, metals, composite materials, etc. It is also conceivable that the locking element 800 can be formed from a material that is more rigid or harder than the outer sheath 706. For example, the material used for the locking element 800 can be selected such that when the tapered portion of the cavity 808 of the locking element 800 is advanced on the sheath 706, the locking element 800 does not deflect, but instead forces the sheath 706 to deflect inward. In some embodiments, the locking element 800 can be formed from a bright (or other) color that is easily noticed by the user.

[0174] Figure 28 Is Figure 27 A three-dimensional cross-sectional view of the far end of the locking element 800, taken at line 28-28. Figure 29 This is a distal view of the locking element 800. The locking element 800 may have variable inner cross-sectional dimensions. In some cases, the cavity 808 may have a generally tapered shape. For example, in some embodiments, the cavity 808 of the locking element 800 may have a first cross-sectional dimension 816 adjacent to its proximal end 802, which increases in a distal direction to a second cross-sectional dimension 818 adjacent to its distal end 804 that is larger than the first cross-sectional dimension 816. The cross-sectional dimensions may gradually transition in a tapered or inclined manner. In other embodiments, the cross-sectional dimensions may change abruptly or gradually. These are merely some examples. In some cases, the wall thickness of the locking element 800 may vary over at least a portion of the locking element. However, this is not necessary. The dimensions of the locking element 800 (e.g., inner diameter, outer diameter, length, slope, etc.) may be varied to create a desired locking effect (described in more detail herein). The distal inner cross-sectional dimension 818 may be configured to allow the locking element 800 to slide freely on the sheath. The smaller proximal internal cross-sectional dimension 816 can be configured to apply a compressive force or a radially inward force to the outer surface of the sheath.

[0175] It is conceivable that the construction of the locking element 800 can be adjusted to create the desired effect. For example, one or more of the internal cross-sectional dimensions 816, 818 can be manufactured larger or smaller to accommodate different sizes of the sheath. In another example, the outer diameter of the locking element 800 can be increased or decreased to facilitate handling. It is also conceivable that the outer surface of the locking element 800 may include features to improve ergonomic handling, such as, but not limited to, protrusions, waves, textures, or notches to improve grip. In some cases, the sheath and / or the locking element 800 may include visual markings to guide the user in manipulating the locking element 800. In some cases, the overall length of the locking element 800 can be increased or decreased as needed. It is also conceivable that the locking element 800 can be large enough to be easily handled, but not so large as to be incompatible with other components, such as, but not limited to, packaging.

[0176] The locking element 800 may further include an axially extending (e.g., parallel to the longitudinal axis of the locking element) protrusion 820 that extends radially inward from the inner surface of the locking element 80. The protrusion 820 may be a rectangular prism, such as, but not limited to, a ridge or other three-dimensional structure, configured to engage a mating groove, notch, or recess within the sheath. The protrusion 820 may be sized and shaped such that when the protrusion 820 is aligned with a mating slot or recess of the sheath, the distal portion of the locking element 800 can slide freely on the sheath. As the locking element 800 is advanced distally, the cavity 808 narrows to apply a radially inward force or compressive force on the sheath.

[0177] The slot of the sheath and the protrusion 820 of the locking element 800 together can create an orientation-dependent assembly. For example, the locking element 800 is oriented such that the protrusion 820 aligns with the slot of the sheath to allow the locking element 800 to advance distally over the sheath. Misalignment of the protrusion 820 with the slot can cause interference between the locking element 800 and the sheath, which will prevent the sheath from entering the locking element 800 and subsequently locking the push wire. This prevents unintended re-engagement of the locking element 800 and the sheath during use of the system if the locking element 800 is not completely removed from the push wire. In the absence of an orientation-dependent feature, if the locking element 800 remains suspended on the push wire, accidental re-engagement with the sheath and the push wire may occur during the advancement of the push wire through the sheath. It is conceivable that other orientation-dependent features may be used on the sheath and / or the locking element 800 as needed.

[0178] Although not explicitly shown, locking element 800 may also include one or more features to provide visual cues about how locking element 800 should be assembled with the sheath. For example, features may include, but are not limited to, visual markings (e.g., arrows, text, etc.) or structural features on the outer surface of locking element 800, as needed.

[0179] In some embodiments, medical device systems 100, 400, 500, 700, actuating wires 102, 402, 502, 702, implants 104, sheaths 106, 406, 506, 706, locking elements 108, 200, 300, 408, 508, 600, 708, 800, and / or components thereof may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels such as 444V, 444L, 314LV stainless steel; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic nickel-titanium alloys; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as...). 625, UNS:

[0180] N06022, such as UNS: N10276, such as other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as...) 400 400 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as MP35- (etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as...) Other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as...). (etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; etc. or any other suitable material.

[0181] As mentioned herein, within the family of commercially available nickel-titanium or nitinol alloys, those designated as "linear elastic" or "non-hyperelastic" can be chemically similar to conventional shape memory and hyperelastic varieties, and can exhibit different and useful mechanical properties. Linear elastic and / or non-hyperelastic nitinols can be distinguished from hyperelastic nitinols because they do not exhibit the large number of "hyperelastic plateaus" or "marker regions" in their stress / strain curves as those of hyperelastic nitinols. Instead, in linear elastic and / or non-hyperelastic nitinols, as recoverable strain increases, stress continues to increase in a substantially linear or slightly, but not necessarily perfectly linear, relationship until plastic deformation begins, or at least in a more linear relationship than the hyperelastic plateaus and / or marker regions observed in hyperelastic nitinols. Therefore, for the purposes of this invention, linear elastic and / or non-hyperelastic nitinols may also be referred to as "substantially" linear elastic and / or non-hyperelastic nitinols.

[0182] In some cases, linear elastic and / or non-hyperelastic nitinol can also be distinguished from hyperelastic nitinol because linear elastic and / or non-hyperelastic nitinol can accept up to about 2 to 5% strain while remaining substantially elastic (e.g., before plastic deformation), while hyperelastic nitinol 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, which can only accept about 0.2 to 0.44% strain before plastic deformation (which can also be distinguished based on its composition).

[0183] In some embodiments, linear elastic and / or non-hyperelastic nickel-titanium alloys are alloys that do not exhibit any martensitic / austenitic phase transformations detectable by differential scanning calorimetry (DSC) and dynamic thermal metallographic analysis (DMTA) over a wide temperature range. For example, in some embodiments, in linear elastic and / or non-hyperelastic nickel-titanium alloys, martensitic / austenitic phase transformations detectable by DSC and DMTA analysis may not be present in the range of about -60 degrees Celsius (°C) to about 120°C. Therefore, the mechanical bending properties of such materials are generally inert to temperature effects over this very wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-hyperelastic nickel-titanium alloys at ambient temperature or room temperature are substantially the same as their mechanical properties at body temperature; for example, they do not exhibit hyperelastic plateaus and / or marker regions. For example, linear elastic and / or non-hyperelastic nickel-titanium alloys retain their linear elastic and / or non-hyperelastic properties and / or characteristics over a wide temperature range.

[0184] In some embodiments, the linear elastic and / or non-hyperelastic nickel-titanium alloy may contain nickel ranging from about 50 to about 60% by weight, with the remainder being substantially titanium. In some embodiments, the composition contains nickel ranging from about 54 to about 57% by weight. An example of a suitable nickel-titanium alloy is the FHP-NT alloy, commercially available from Furukawa TechnoMaterial Co., Kanagawa Prefecture, Japan. Other suitable materials may include ULTANIUM. TM (Available from Neo-Metrics) and GUM METAL TM (Available from Toyota). In some other embodiments, the desired properties can be achieved using a superelastic alloy, such as a superelastic nitinol.

[0185] In at least some embodiments, medical device systems 100, 400, 500, 700, actuating wires 102, 402, 502, 702, implants 104, sheaths 106, 406, 506, 706, locking elements 108, 200, 300, 408, 508, 600, 708, 800, and / or components thereof may also be doped with, made of, or otherwise comprised of a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluorescent fluoroscopic screen or using another imaging technique during medical procedures. The relatively bright image helps the user determine the location of medical device systems 100, 400, 500, 700, push wires 102, 402, 502, 702, implant 104, sheaths 106, 406, 506, 706, locking elements 108, 200, 300, 408, 508, 600, 708, 800, and / or their components. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials loaded with radiopaque fillers. Alternatively, other non-transparent marking strips and / or coils can be incorporated into the design of medical device systems 100, 400, 500, 700, push wires 102, 402, 502, 702, implants 104, sheaths 106, 406, 506, 706, locking elements 108, 200, 300, 408, 508, 600, 708, 800 and / or their components to achieve the same result.

[0186] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to medical device systems 100, 400, 500, 700, push wires 102, 402, 502, 702, implants 104, sheaths 106, 406, 506, 706, locking elements 108, 200, 300, 408, 508, 600, 708, 800, and / or components thereof. For example, medical device systems 100, push wires 102, implants 104, sheaths 106, locking elements 108, 200, and / or components thereof, or portions thereof, may be made of materials that substantially do not distort the image and do not create a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may create artifacts in MRI images. The medical device system 100, the actuating wire 102, the implant 104, the sheath 106, the locking element 108, 200, etc., or parts thereof, may also be made of materials that can be imaged by an MRI machine. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as...). (etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as MP35- (etc.), nickel-titanium, etc., and others.

[0187] In some embodiments, medical device systems 100, 400, 500, 700, actuating wires 102, 402, 502, 702, implants 104, sheaths 106, 406, 506, 706, locking elements 108, 200, 300, 408, 508, 600, 708, 800, and / or components thereof may be made of or comprise of polymers or other suitable materials. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), and polyoxymethylene (POM, e.g., available from DuPont). Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), and polyether esters (e.g., available from DSM Engineering Plastics) ), ether or ester copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those available from DuPont) ), polyamide (e.g., available from Bayer) Or it can be purchased from Elf Atochem. ), elastomer polyamide, block polyamide / ether, polyether block amide (PEBA, for example, can be listed by trade name) Purchased), ethylene vinyl acetate copolymer (EVA), silicone resin, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., Polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., Polysulfone, nylon, nylon-12 (such as those available from EMS American Grilon) Perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0188] In some embodiments, the medical device systems 100, 400, 500, 700, actuating wires 102, 402, 502, 702, implants 104, sheaths 106, 406, 506, 706, locking elements 108, 200, 300, 408, 508, 600, 708, 800, and / or components thereof disclosed herein may include a fabric material disposed above or within a structure. The fabric material may consist of a biocompatible material suitable for promoting inward tissue growth, such as a polymeric material or a biomaterial. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials (such as polyethylene), polypropylene, polyester, polyurethane, and / or mixtures or combinations thereof.

[0189] In some embodiments, medical device systems 100, 400, 500, 700, actuating wires 102, 402, 502, 702, implants 104, sheaths 106, 406, 506, 706, locking elements 108, 200, 300, 408, 508, 600, 708, 800, and / or components thereof may include textile materials and / or be formed from textile materials. Some examples of suitable textile materials may include synthetic yarns, which may be flat, shaped, twisted, deformed, pre-shrinked, or non-shrinked. Suitable synthetic biocompatible yarns for use in this invention include, but are not limited to, polyesters, including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefins, polyvinyl chloride, polymethyl methacrylate, polyamide, naphthalene dicarboxylate derivatives, natural silk, and polytetrafluoroethylene. Furthermore, at least one of the synthetic yarns may be a metal yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include those made of or containing stainless steel, platinum, gold, titanium, tantalum, or Ni-Co-Cr based alloys. Yarns may also include carbon fiber, glass fiber, or ceramic fiber. Preferably, the yarn is made of thermoplastic materials, including but not limited to polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, etc. The yarn can be multifilament, monofilament, or staple fiber. The type of yarn and denier selected can be chosen according to the method of forming biocompatible and implantable prostheses, and especially vascular structures with desired characteristics.

[0190] In some embodiments, the medical device system 100, 400, 500, 700, actuating wire 102, 402, 502, 702, implant 104, sheath 106, 406, 506, 706, locking element 108, 200, 300, 408, 508, 600, 708, 800 and / or components thereof may include suitable therapeutic agents and / or be treated therewith. Examples of suitable therapeutic agents may include anticoagulants (such as heparin, heparin derivatives, urokinase, and PPack (d-phenylalanine-proline-arginine-chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptidase, monoclonal antibodies that block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory drugs (such as dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalazine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, vinblastine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); and anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone). Ketones, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides; angiogenesis promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); angiogenesis inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, and bifunctional molecules composed of antibodies and cytotoxins); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0191] It should be understood that the present invention is merely illustrative in many respects. Changes may be made in details, particularly in terms of shape, size, and arrangement of steps, without departing from the scope of the invention. To the appropriate extent, this may include the use of any of the features of an example embodiment used in other embodiments. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A medical device comprising: A sheath having a proximal end, a distal end, an intermediate region disposed between the proximal end and the distal end, and a cavity extending from the proximal end to the distal end; A push wire, which is slidably disposed within the cavity of the sheath; as well as A locking element having a proximal region, a distal region, an intermediate region disposed between the proximal region and the distal region, and a cavity extending from the proximal region to the distal region, the locking element having a first inner diameter adjacent to the distal region and a second inner diameter adjacent to the proximal region, the second inner diameter being smaller than the first inner diameter; The locking element further includes a slot extending from the proximal region of the locking element to the distal region of the locking element, the slot extending through the thickness of the wall of the locking element, the slot having a width greater than the width of the push wire and less than the width of the sheath; The distal region of the locking element is configured to slide freely on the sheath; as well as When the proximal region of the locking element is disposed on the sheath, the locking element is configured to press the sheath radially inward.

2. The medical device of claim 1, wherein the diameter of the cavity of the locking element in the proximal region decreases obliquely toward the proximal end of the locking element.

3. The medical device according to any one of claims 1 to 2, wherein the cavity of the locking element in the distal region has a substantially uniform inner diameter.

4. The medical device according to any one of claims 1 to 2, wherein the sheath includes a first slot and a second slot, the first slot and the second slot extending distally from the proximal end of the sheath and extending less than the entire length of the sheath.

5. The medical device according to any one of claims 1 to 2, wherein the sheath includes an angled protrusion extending radially outward from its outer surface.

6. The medical device of claim 5, wherein the diameter of the angled protrusion of the sheath decreases in the proximal direction.

7. The medical device of claim 5, wherein the locking element includes an angled protrusion extending radially inward from the inner surface of the cavity of the locking element.

8. The medical device of claim 7, wherein the diameter of the angled protrusion of the locking element decreases in the distal direction.

9. The medical device of claim 7, wherein the angled protrusion of the sheath and the angled protrusion of the locking element are configured to cooperate to restrict axial movement of the locking element.

10. The medical device according to any one of claims 1 to 2, wherein the locking element comprises a plurality of circumferentially extending ribs extending from its outer surface.

11. The medical device according to any one of claims 1 to 2, wherein the locking element is formed of a material that is more rigid than the sheath.

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