Medical Device Release Systems

Abstract

The medical device system (100) may include an elongated shaft (110) having an inner cavity extending from a proximal end to a distal end (116), a proximal release line (120), and a distal release line (112). The proximal release line (120) may extend distally from a proximal end configured to remain outside the body to a distal end (126) and may be slidably disposed within the inner cavity of the elongated shaft (110). The distal release line (122) may extend from a proximal end (138) to a distal end (140) and may be slidably disposed within the inner cavity of the elongated shaft (110). The proximal end (138) of the distal release line (122) may be slidably coupled to the distal end (126) of the proximal release line (120). The distal release line (122) may be configured to releasably attach a medical device (130) to the distal end (116) of the elongated shaft (110).

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 904,893, filed on September 24, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to medical devices and methods for making and / or using medical devices. More specifically, the present disclosure relates to the construction of a system for releasing a medical implant. Background Art

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

[0005] In a first example, a medical device system may include: an elongated shaft having an inner cavity extending from a proximal end of the elongated shaft to a distal end of the elongated shaft; a proximal release line extending distally from the proximal end to a proximal end configured to remain outside the body and slidably disposed within the inner cavity of the elongated shaft; and a distal release line extending distally from the proximal end to the distal end and slidably disposed within the inner cavity of the elongated shaft, the proximal end of the distal release line being slidably coupled to the distal end of the proximal release line. The distal release line may be configured to releasably attach a medical device to the distal end of the elongated shaft.

[0006] Alternatively or in addition to any of the above examples, in another example, the distal end of the proximal release line can be formed as a proximal loop and the proximal end of the distal release line can be formed as a distal loop.

[0007] Alternatively or in addition to any of the above examples, in another example, the proximal ring and the distal ring can be slidably coupled.

[0008] Alternatively or in addition to any of the above examples, in another example, the distal ring can be configured to frictionally engage an inner surface of the elongated shaft.

[0009] Alternatively or in addition to any of the above examples, in another example, the proximal ring can extend substantially parallel to the first plane.

[0010] Alternatively or in addition to any of the above examples, in another example, the distal ring can extend generally parallel to a second plane that is generally perpendicular to the first plane.

[0011] Alternatively or in addition to any of the above examples, in another example, the inner surface of the distal end of the proximal ring can be configured to engage the inner surface of the proximal end of the distal ring when the proximal release wire is actuated proximally.

[0012] Alternatively or in addition to any of the above examples, in another example, the distal end of the proximal release line may form one or more helical windings.

[0013] Alternatively or in addition to any of the above examples, in another example, one or more helical windings of the proximal release line may be disposed over a portion of the distal release line.

[0014] Alternatively or in addition to any of the above examples, in another example, the proximal end of the distal release line can form one or more helical windings.

[0015] Alternatively or in addition to any of the above examples, in another example, one or more helical windings of the distal release line may be disposed over a portion of the proximal release line.

[0016] Alternatively or in addition to any of the above examples, in another example, the one or more helical windings of the distal release wire can be configured to frictionally engage the inner surface of the elongated shaft.

[0017] Alternatively or in addition to any of the above examples, in another example, the proximal-most winding of the distal end of the proximal release line may be configured to engage with the distal-most winding of the proximal end of the distal release line when the proximal release line is actuated proximally.

[0018] Alternatively or in addition to any of the above examples, in another example, the proximal release wire can be configured to independently move proximally from the distal release wire over a predetermined axial distance along the longitudinal axis of the elongated shaft.

[0019] Alternatively or in addition to any of the above examples, in another example, proximal movement of the proximal release line greater than a predetermined axial distance may be used to cause the distal release line to move in unison with the proximal release line.

[0020] In another example, a medical device system may include: an elongated shaft having an inner cavity extending from a proximal end of the elongated shaft to a distal end of the elongated shaft; a proximal release line extending distally from a proximal end configured to remain outside the body to a distal end and slidably disposed within the inner cavity of the elongated shaft; and a distal release line extending distally from the proximal end to the distal end and slidably disposed within the inner cavity of the elongated shaft, the proximal end of the distal release line being slidably coupled to the distal end of the proximal release line. The distal release line may be configured to releasably attach a medical device to the distal end of the elongated shaft.

[0021] Alternatively or in addition to any of the above examples, in another example, the distal end of the proximal release line can form a distal loop.

[0022] Alternatively or in addition to any of the above examples, in another example, the proximal end of the distal release line can form a distal loop.

[0023] Alternatively or in addition to any of the above examples, in another example, the proximal ring and the distal ring can be slidably coupled.

[0024] Alternatively or in addition to any of the above examples, in another example, the inner surface of the distal end of the proximal ring can be configured to engage the inner surface of the proximal end of the distal ring when the proximal release wire is actuated proximally.

[0025] Alternatively or in addition to any of the above examples, in another example, the distal end of the proximal release line may form one or more helical windings.

[0026] Alternatively or in addition to any of the above examples, in another example, one or more helical windings of the proximal release line may be disposed over a portion of the distal release line.

[0027] Alternatively or in addition to any of the above examples, in another example, the distal end of the proximal release line may form one or more helical windings.

[0028] Alternatively or in addition to any of the above examples, in another example, one or more helical windings of the proximal release line may be disposed over a portion of the distal release line.

[0029] Alternatively or in addition to any of the above examples, in another example, one or more helical windings of the distal release wire can be configured to frictionally engage an inner surface of the elongated shaft.

[0030] Alternatively or in addition to any of the above examples, in another example, the proximal-most winding of the distal end of the proximal release line may be configured to engage with the distal-most winding of the proximal end of the distal release line when the proximal release line is actuated proximally.

[0031] Alternatively or in addition to any of the above examples, in another example, the proximal release wire can be configured to independently move proximally from the distal release wire over a predetermined axial distance along the longitudinal axis of the elongated shaft.

[0032] Alternatively or in addition to any of the above examples, in another example, proximal movement of the proximal release line greater than a predetermined axial distance may be used to cause the distal release line to move in unison with the proximal release line.

[0033] In another example, a medical device system may include: an elongated shaft having a lumen extending from a proximal end of the elongated shaft to a distal end of the elongated shaft; a proximal release line extending from a proximal end configured to remain outside the body to a looped distal end and slidably disposed within the lumen of the elongated shaft; and a distal release line extending distally from the looped proximal end to the distal end and slidably disposed within the lumen of the elongated shaft, the looped proximal end of the distal release line being slidably coupled to the looped distal end of the proximal release line. The distal release line may be configured to releasably attach a medical device to the distal end of the elongated shaft. Proximal movement of the proximal release line over a first distance may cause the proximal release line to move independently of the distal release line and proximal movement of the proximal release line over a second distance greater than the first distance may cause the distal release line to move in unison with the proximal release line.

[0034] Alternatively or in addition to any of the above examples, in another example, the first distance can be equal to or less than the length of the hole of the looped proximal end of the distal release line.

[0035] Alternatively or in addition to any of the above examples, in another example, the inner surface of the distal end of the proximal looped end of the distal release line may be configured to engage with the inner surface proximal to the proximal looped distal end of the proximal release line when the proximal release line is actuated proximally over a distance greater than the first distance.

[0036] Alternatively or in addition to any of the above examples, in another example, the proximal end of the loop can extend generally parallel to a first plane and the distal end of the loop can extend generally parallel to a second plane that is generally perpendicular to the first plane.

[0037] In another example, a medical device system may include: an elongated shaft having a lumen extending from a proximal end of the elongated shaft to a distal end of the elongated shaft; a proximal release line extending distally from a proximal end configured to remain outside the body to a distal end and slidably disposed within the lumen of the elongated shaft, wherein the distal end of the proximal release line includes one or more helical windings, and the distal release line extends distally from the proximal end to the distal end and is slidably disposed within the lumen of the elongated shaft, and the proximal end of the distal release line includes a plurality of windings slidably coupled over a linear portion of the proximal release line. The distal release line may be configured to releasably attach a medical device to the distal end of the elongated shaft. Proximal movement of the proximal release line over a first distance may cause the proximal release line to move independently of the distal release line and proximal movement of the proximal release line over a second distance greater than the first distance may cause the distal release line to move in unison with the proximal release line.

[0038] Alternatively or in addition to any of the above examples, in another example, the proximal-most winding of the distal end of the proximal release line may be configured to engage the distal-most winding of the proximal end of the distal release line upon proximal movement of the proximal release line greater than the first distance.

[0039] Alternatively or in addition to any of the above examples, in another example, the proximal end of the distal release line can be disposed proximal to the distal end of the proximal release line.

[0040] The above summary of some embodiments, aspects and / or examples is not intended to describe each embodiment or every example of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The present disclosure may be more fully understood based on the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0042] Figure 1 is a perspective view of an exemplary medical device system;

[0043] Figure 2 yes Figure 1 A partial cross-sectional view of an illustrative medical device system;

[0044] Figure 3 yes Figure 1 A perspective view of a distal portion of an illustrative medical device system;

[0045] Figure 4-Figure 8 illustrates actuation of a portion of an exemplary medical device system;

[0046] Fig. 9 An exemplary release mechanism of an exemplary medical device system is shown; and

[0047] Fig.10 A partial cross-sectional view of another exemplary medical device system is shown.

[0048] Although various aspects of the present disclosure may have various modifications and alternative forms, details thereof have been disclosed by way of example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit the various aspects of the present disclosure to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0049] The following description should be read with reference to the accompanying drawings which are not necessarily drawn to scale, wherein similar reference numerals represent similar elements in all several views. The detailed description and the accompanying drawings are used to illustrate but not limit the invention claimed for protection. Those skilled in the art will recognize that the various elements described and / or illustrated can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and the accompanying drawings illustrate exemplary embodiments of the invention claimed for protection. However, for clarity and ease of understanding, although each feature and / or element may not be shown in each figure, the feature and / or element may be understood to exist unless otherwise stated.

[0050] For the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0051] All numerical values ​​herein are assumed to be modified by the word "about", whether or not explicitly indicated. In the context of numerical values, the word "about" generally refers to a range of numbers that one skilled in the art would consider equivalent to the stated value (e.g., having the same function or result). In many cases, the word "about" may include numbers that are rounded to the nearest significant figure. Other uses of the word "about" (e.g., in contexts other than numerical values) may be assumed to have their ordinary and customary definitions, as understood from the context of and consistent with this specification, unless otherwise indicated.

[0052] The recitation of numerical ranges by endpoints includes all numbers within that range inclusive of the endpoints (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0053] Although some suitable sizes, ranges and / or values ​​pertaining to various components, features and / or specifications are disclosed, those skilled in the art, in light of this disclosure, will appreciate that the desired sizes, ranges and / or values ​​may deviate from the explicitly disclosed sizes, ranges and / or values.

[0054] As used in this specification and the appended claims, the singular forms "one", "a kind of", and "the" include plural referents unless the context clearly indicates otherwise. As used in this specification and the appended claims, the word "or" is generally used with its meaning including "and / or", unless the context clearly indicates otherwise. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in singular form, even if these features may be plural or recurring within the disclosed embodiments. Each case of these features may include singular disclosures and / or be included by singular disclosures, unless the contrary is explicitly stated. For the purpose of simplicity and clarity, not all elements of the disclosed invention must be shown in each figure or discussed in detail below. However, it should be understood that the following discussion is equally applicable to any and / or all parts where there is more than one, unless the contrary is explicitly stated. In addition, for clarity, not all cases of some elements or features are shown in each figure.

[0055] Relative terms such as "proximal", "distal", "advance", "retract", their variants, etc. can generally be considered with respect to the positioning and / or operation of various elements relative to the user / operator / manipulator of the device, wherein "proximal" and "retract" represent or refer to being closer to or toward the user and "distal" and "advance" represent or refer to being further away from or away from the user. In some cases, in order to facilitate the understanding of the present disclosure, the terms "proximal" and "distal" can be arbitrarily specified, and this situation will be easily understood by those skilled in the art. Other relative terms such as "upstream", "downstream", "inflow" and "outflow" refer to the direction of fluid flow inside a cavity (such as a body cavity, a blood vessel) or inside a device. Other relative terms such as "axial", "circumferential", "longitudinal", "lateral", "radial", etc. and / or their variants generally refer to the direction and / or orientation relative to the longitudinal center axis of the disclosed structure or device.

[0056] The term "range (span, xtent)" can be understood to mean the maximum measurement of the stated or confirmed size, unless explicitly referred to as the minimum range. For example, "outer range" can be understood to mean the maximum outer dimension, "radial range" can be understood to mean the maximum radial dimension, "longitudinal range" can be understood to mean the maximum longitudinal dimension, etc. The various cases of "range" can be different (e.g., axial, longitudinal, lateral, axial, circumferential, etc.) and will be obvious to those skilled in the art from the context of their respective use. Generally, "range" can be considered to be the maximum possible size measured according to the intended use. However, in the case of being referred to as the "minimum range", "range" should refer to the minimum possible size measured according to the intended use. In some cases, "range" can usually be measured orthogonally in a plane and / or section, but as will be apparent from the specific context, it can be measured in different ways, such as but not limited to: angularly, radially, circumferentially (e.g., along an arc), etc.

[0057] It should be noted that references to "an embodiment", "some embodiments", "other embodiments", etc. in this specification indicate that the described embodiment may include specific features, structures, or characteristics, but each embodiment may not necessarily include the specific features, structures, or characteristics. In addition, such phrases are not necessarily directed to the same embodiment. In addition, when a specific feature, structure, or characteristic is described in conjunction with an embodiment, it will be within the knowledge of those skilled in the art to implement the specific feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described, unless the contrary is explicitly stated. That is, the various individual elements described below, even if not explicitly shown in a particular combination, can be conceivably combined or arranged with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as will be understood by those skilled in the art.

[0058] For the purpose of clarity, in the entire description and / or claims, the digital nomenclature of certain identifications (e.g., first, second, third, fourth, etc.) can be used to specify and / or distinguish between various described and / or claimed features. It should be understood that this digital nomenclature is not intended to be restrictive but only exemplary. In some embodiments, for the sake of brevity and clarity, changes and deviations from the digital nomenclature used above can be made. That is, the feature identified as the "first" element can be subsequently referred to as the "second" element, the "third" element, etc. or can be completely omitted, and / or different features can be referred to as the "first" element. The meaning and / or nomenclature in each case will be apparent to those skilled in the art.

[0059] Diseases and / or conditions that affect and / or are affected by the cardiovascular system are common throughout the world. For example, some forms of arteriovenous malformations (AVMs) are "dependent" on normal blood flow through the vascular system. Without being bound by any theory, it is generally believed that arteriovenous malformations and / or other diseases or conditions can be treated (at least in part) by depriving them of normal oxygen- and / or nutrient-rich blood flow, thereby limiting their ability to grow and / or spread. Other examples of diseases or conditions that may benefit from vascular occlusion include, but are not limited to: bleeding, aneurysms, venous insufficiency, cutting off blood flow before organ resection, or preventing the backflow of embolic microspheres into branching vessels in the liver. Disclosed herein are medical devices that can be used in a portion of the cardiovascular system to treat and / or repair some arteriovenous malformations and / or other diseases or conditions. The devices disclosed herein may also provide several additional desirable features and benefits, as described in more detail below.

[0060] Figure 1 and Figure 2 Aspects of an exemplary medical device system 100 are shown. The medical device system 100 may include an elongated shaft 110 having a lumen 112 extending from a proximal end 114 of the elongated shaft 110 to a distal end 116 of the elongated shaft 110 (e.g., Figure 2 ). In some embodiments, the elongated shaft 110 can be a catheter, a hypotube, or other similar tubular structure. In some embodiments, at least a portion of the elongated shaft 110 can include micromachining, multiple grooves or weakened areas, some degree of material removal, etc., to provide increased flexibility along the length of the elongated shaft 110 to pass through tortuous vascular systems. Some suitable but non-limiting materials (e.g., metal materials, polymer materials, composite materials, etc.) for the elongated shaft 110 are described below.

[0061] The medical device system 100 may include a proximal release wire (or delivery system pull wire) 120 and a distal release wire (or coupling pull wire) 122 (eg, Figure 2). The medical device 130 can be disposed proximate to the distal end 116 of the elongated shaft 110. The proximal and distal release wires 120, 122 can slide axially relative to the medical device 130 between an interlocking position and a release position, as will be described in more detail herein. The proximal and distal release wires 120, 122 can be configured to releasably attach the medical device 130 to the distal end 116 of the elongated shaft 110. The medical device 130 can be configured to expand from a delivery configuration to a placement configuration. For simplicity, the medical device 130 is illustrated herein as an embolic coil, but other suitable medical devices that are transmitted, delivered, used, released, etc. in a similar manner are also conceivable, including but not limited to: vascular occlusion devices, stents, embolic filters, replacement heart valves, other occlusion devices and / or other medical implants, etc. In some embodiments, the proximal and / or distal release wires 120, 122 can be alternately and / or interchangeably referred to as pull wires, drive wires, and / or locking wires. The proximal and distal release wires 120, 122 can generally be solid wires or shafts, but can also be tubular in some embodiments. Some suitable but non-limiting materials (eg, metal materials, polymer materials, composite materials, etc.) for the release wire 120 are described below.

[0062] In some embodiments, the medical device system 100 may include a microcatheter 190 that is sized and configured to deliver the medical device 130 to a treatment site in a delivery configuration. The elongated shaft 110 and the medical device 130 may be slidably disposed within a lumen 192 of the microcatheter 190 (e.g., Figure 2 ). In some embodiments, microcatheter 190 can facilitate percutaneous delivery of medical device 130 to a treatment site. For reference only, in the accompanying drawings (e.g., Figure 1-Figure 9 ), the medical device 130 may be shown in a delivery configuration or at least a partially deployed configuration. Those skilled in the art will recognize that the medical device 130 may expand and / or coil on itself when the medical device 130 is deployed. Some suitable but non-limiting materials (e.g., metal materials, polymer materials, composite materials, etc.) for the microcatheter 190 are described below.

[0063] Figure 3 An enlarged perspective view of the distal end 116 of the elongated shaft 110 is shown, wherein the elongated shaft 110, the medical device 130, and the microcatheter 190 are shown transparently. The proximal release line 120 extends from a proximal end 124 (e.g., Figure 2) extends distally to a distal end 126. In some cases, the distal end 126 of the proximal release line 120 can be located proximal to the medical device 130. The distal end 126 can be a looped distal end 126, forming a loop or proximal loop 128 defining an aperture 134. The proximal loop 128 can have a generally oval shape, thereby having a closed proximal end 132 and a closed distal end 136. However, as desired, the proximal loop 128 can have other shapes, such as but not limited to circular, rectangular, square, etc. The proximal loop 128 can generally extend in a manner generally parallel to the first plane.

[0064] The distal release line 122 extends distally from the proximal end 138 to the distal end 140. The distal end 140 of the distal release line 122 can be slidably coupled to the release mechanism 170, as will be described in more detail herein. The proximal end 138 can be generally located adjacent to the distal end 126 of the proximal release line 120. For example, the proximal end 138 of the distal release line 122 can overlap a portion of the length of the distal end 126 of the proximal release line 120. The proximal end 138 can be a looped proximal end, thereby forming a distal loop or ring 142 that defines the hole 144. The distal ring 142 can have a generally oval shape, thereby having a closed proximal end 146 and a closed distal end 148. However, as desired, the distal ring 42 can have other shapes, such as but not limited to: circular, rectangular, square, etc. The distal ring 42 can generally extend in a manner generally parallel to a second plane, which is generally perpendicular to the first plane.

[0065] In some embodiments, the proximal and distal loops 42 may be formed by using metal draw wires and lap welding or tack welding one end of the wire in the loop. It is contemplated that some illustrative metals may include stainless steel, Nitinol, and others, as described in more detail below. If Nitinol is used, heat setting may be applied to form the loop into the specific geometry desired.

[0066] The distal end 126 of the proximal release wire 120 can be slidably coupled to the proximal end 138 of the distal release wire 122. For example, the distal end 136 of the proximal loop of the proximal release wire 120 can be disposed within the hole 144 of the distal loop 42 of the distal release wire 122 in an interlocking arrangement. Similarly, the proximal end 146 of the distal loop 42 of the distal release wire 122 can be disposed within the hole 134 of the proximal loop 142 of the proximal release wire 120 to form a sliding joint 160. This can allow the proximal release wire 120 and the distal release wire 122 to be slidably coupled to each other over a limited or predetermined axial distance (e.g., along the longitudinal axis of the system 100). It is contemplated that the proximal release wire 120 and the distal release wire 122 can each be independently movable relative to each other over a limited axial distance. The length of the apertures 134, 144 may determine the distance the proximal release line 120 and / or the distal release line 122 may slide independently before engaging with the other component 120, 122 and also causing it to move.

[0067] The sliding arrangement of the proximal release wire 120 and the distal release wire 122 can help mitigate premature separation of the medical device 130. For example, when the delivery system 100 (and the medical device 130) is retracted proximally (and at other times during use), the elongated shaft 110 may be subjected to tensile loads. In other words, the distal portion of the elongated shaft 110 may stretch, which may cause the retention wire to separate prematurely from the medical device 130. The proximal end 124 of the proximal release wire 120 (or an area adjacent thereto) may be coupled to the proximal end 114 of the elongated shaft 110 (or an area adjacent thereto) to limit or prevent movement of the proximal release wire 120 relative to the elongated shaft. However, this may cause the distal release wire 122 to stretch along with the elongated shaft 110. The sliding arrangement of the proximal release line 120 and the distal release line 122 can allow the proximal release line 120 to move proximally (e.g., stretch) as the distal portion of the elongated shaft 110 stretches without applying a proximal force to the distal release line 122. For example, if the proximal release line 120 and the distal release line 122 can be arranged so that the distal end 136 of the proximal loop 128 of the proximal release line 120 is in contact with or adjacent to the inner surface of the distal end 148 of the distal loop 142 of the distal release line 122, this can allow the proximal release line 120 to move proximally the entire length of the hole 144 of the distal loop 142 before a proximal force is applied to the distal release line 122. Once the inner surface of the distal end 136 of the proximal loop 28 engages the inner surface of the proximal end 146 of the distal loop 142, the distal release line 122 moves proximally with the proximal release line 120, as will be described in more detail herein.

[0068] Figure 4-Figure 9The medical device 130 is generally shown being released from the elongated shaft 110 (e.g., at a treatment site). In use, the microcatheter 190 of the medical device system 100 can be inserted into the patient's anatomical structure, and the distal end of the microcatheter 190 can be guided and / or advanced to a position adjacent to the treatment site. The medical device 130 disposed and / or adjacent to the distal end 116 of the elongated shaft 110 can be inserted into the proximal end of the lumen 192 disposed inside the microcatheter 190 and advanced through the microcatheter 190 and / or advanced to the treatment site with the microcatheter 190. In some embodiments, the medical device 130 can be disposed inside the lumen 192 of the microcatheter 190 and adjacent to the distal end of the microcatheter 190. In some embodiments, the medical device 130 can be disposed inside the lumen 192 of the microcatheter 190 adjacent to the distal end of the microcatheter 190 prior to use and / or prior to inserting the microcatheter 190 into the patient's anatomical structure. Depending on the type of medical device and / or the desired treatment procedure or method, the placement and / or release of the medical device 130 may be selectively performed. When the medical device 130 is ready to be placed, the elongated shaft 110 may be advanced and / or translated distally relative to the microcatheter 190 until the medical device 130 is exposed and / or disposed distally of the microcatheter 190, such as Figure 4 Alternatively, the microcatheter 190 can be retracted relative to the elongated shaft 110 until the medical device 130 is exposed and / or disposed distally of the microcatheter 190. For clarity, the microcatheter 190 is illustrated in a proximally retracted configuration. However, it should be understood that the microcatheter can be disposed above the medical device 130 during guidance through the body.

[0069] The release mechanism 170 can releasably attach the medical device 130 to the distal end 116 of the elongated shaft 110. In some embodiments, the elongated shaft 110 can include a first portion 172 of the release mechanism 170 fixedly attached to the distal end 116 of the elongated shaft 110, and the medical device 130 can include a second portion 174 of the release mechanism 170 fixedly attached to the proximal end of the medical device 130. The distal end 140 of the distal release line 122 can be slidably engaged with the first portion 172 of the release mechanism 170 and the second portion 174 of the release mechanism 170 in an interlocking position, such as in Figure 4 When the proximal release line 120 and the distal release line 122 are in the delivery configuration, the distal release line 122 interlocks the first portion 172 of the release mechanism 170 with the second portion 174 of the release mechanism 170, as shown in FIG. Figure 4 It should be noted that this delivery configuration does not require that the distal end 136 of the proximal ring 128 abut or contact the inner surface of the distal end 148 of the distal ring 42, as shown. Figure 4The proximal release line 120 and the distal release line 122 are shown in an arrangement that allows for a maximum sliding joint clearance 150. The sliding joint clearance 150 can determine the distance that the elongated shaft 110 can be extended before movement of the distal release line 122 can be seen. The sliding joint clearance 150 can be modified by changing the length of the proximal hole 134 and / or the distal hole 144. In some cases, the holes 134, 144 can each have a length in the range of about 0.25 centimeters (cm) to about 3 cm, about 0.5 cm to about 2 cm, about 0.75 cm to about 1.25 cm, or about 1 cm. It is contemplated that, depending on the application, the holes 134, 144 can have a length less than 0.25 cm or greater than 3 cm. In addition, the holes 134, 144 need not have the same length.

[0070] When the delivery system 100 is advanced proximally to the treatment site, the elongated shaft 110 may begin to expand. In some cases, the proximal release wire 120 may be coupled to the elongated shaft 110 to prevent longitudinal movement of the proximal release wire 120 relative to the elongated shaft 110 during delivery. This may cause the proximal release wire 120 to expand with the elongated shaft 110. Figure 5 The sliding joint 160 is shown with the cutout portion extended. Figure 5 As can be seen in FIG. 1 , the proximal release line 120 has been displaced in the distal direction (as indicated by arrow 162), while the distal release line 122 remains longitudinally fixed. Figure 5 As can be seen in FIG. 1 , there is a gap length 152 in the sliding joint 160. However, the length 152 is less than Figure 4 The length 150 of the configuration shown in FIG. Movement of the proximal release line 120 may be due to stretching or user actuation.

[0071] When detachment of the medical device 130 is desired, the user may separate the elongated shaft 110 from the proximal release wire 120 (if so attached) to allow proximal retraction of the proximal release wire 120. The proximal end 124 of the proximal release wire 120 may be proximally driven a first distance, as indicated at arrow 162, until the length of the gap of the sliding joint 160 has been consumed, as shown. Figure 6 As shown in . It is contemplated that the length of the gap may be variable depending on the degree of extension of the elongated shaft 110 and / or the initial configuration of the proximal ring relative to the distal ring 42. Once the inner surface of the distal end 136 of the proximal ring 128 engages the inner surface of the proximal end 146 of the distal ring 142, the proximal release line 120 is further moved distally a second distance (e.g., beyond the predetermined distance of the gap or greater than the first distance) causing the distal release line 122 to be actuated distally in unison with the proximal release line 120, as shown in . Figure 7In some cases, the distal loop 42 of the distal release line 122 may have an interference fit (or frictionally engage) with the inner wall of the elongated shaft 110. This may secure the distal release line 122 until the user intentionally applies force to the proximal release line 120. This arrangement may help reduce passive migration of the distal release line 122.

[0072] It is contemplated that release mechanism 170 may remain in the interlocked configuration until distal release wire 122 has been driven proximally a length that is equal to or greater than the length of release mechanism 170 . Figure 8 and Fig. 9 System 100 is shown with medical device 130 in a deployed configuration. For example, actuating distal release wire 122 proximally by a length less than the length of release mechanism 170 may not be sufficient to release medical device 130. In at least some embodiments, distal release wire 122 can be slidably disposed within lumen 112 extending through elongated shaft 110, a first axial lumen extending through first portion 172 of release mechanism 170, and a second axial lumen extending through second portion 174 of release mechanism 170. It is contemplated that release of medical device 130 can be reversed at any axial position of distal release wire 122 between the interlocked configuration and the fully released configuration (e.g., Figure 8 and Fig. 9 ). When the medical device 130 is releasably attached to the distal end 116 of the elongated shaft 110, the first axial lumen of the first portion 172 and the second axial lumen of the second portion 174 can be substantially coaxial with the longitudinal center axis and / or the distal release line 122. Some suitable but non-limiting materials (e.g., metal materials, polymer materials, composite materials, etc.) for the release mechanism 170, the first portion 172, and the second portion 174 are described below.

[0073] Return to reference Figure 7 and Figure 8 , the elongated shaft 110 can have a sufficient length so that the proximal end 114 of the elongated shaft 110 and / or the proximal release wire 120 remain proximal to the microcatheter 190 (e.g., extend proximally therefrom) when the medical device 130 is disposed distally of the microcatheter 190. In use, the elongated shaft 110 can have a sufficient length to reach a location external to the patient from the treatment site where the medical device system 100 can be manipulated by an operator (e.g., a clinician, a physician, a user, etc.). After inserting the medical device system 100 into the treatment site, the operator of the medical device system 100 can place a first hand at the proximal end 114 of the elongated shaft 110 and a second hand at the proximal end 124 of the proximal release wire 120, thereby manipulating the proximal release wire 120 and / or the distal release wire 122 to release the medical device 130.

[0074] Although not explicitly shown, the medical device system 100 may include an introducer configured to load the medical device 130 into the microcatheter 190. The introducer may be a tubular member having an inner cavity extending from a proximal end to a distal end. The introducer may hold the medical device 130 to a reduced diameter and / or in a transport configuration for loading into the microcatheter 190. After the medical device 130 is loaded into the microcatheter 190, the introducer may be retracted proximally on and relative to the elongated shaft 110 and removed from the medical device system 100.

[0075] In use, a method of delivering a medical device 130 to a treatment site (e.g., a vein, an artery, etc.) may include inserting a microcatheter 190 into an anatomical structure of a patient and guiding the distal end of the microcatheter 190 to a position adjacent to the treatment site. The method may include inserting the medical device 130 disposed at and / or adjacent to the distal end 116 of the elongated shaft 110 into the proximal end of a lumen 192 disposed within the microcatheter 190. In some embodiments, after the microcatheter 190 is inserted into the anatomical structure of the patient, the medical device 130 may be inserted into the lumen 192 of the microcatheter 190. The method may include advancing the medical device 130 through the microcatheter 190 to the treatment site. The medical device 130 may be releasably attached to the distal end 116 of the elongated shaft 110 by a pull line (e.g., a proximal release line 120 and / or a distal release line 122, etc.) extending through the lumen 112 within the elongated shaft 110. The proximal release wire 120 may extend proximally from the elongated shaft 110, and the proximal release wire 120 may be releasably coupled to the elongated shaft 110. Alternatively, in some embodiments, the medical device 130 may be inserted into the proximal end of the lumen 192 of the microcatheter 190 and advanced through the microcatheter 190 to the distal end of the microcatheter 190 before the microcatheter 190 is inserted into the patient's anatomy.

[0076] As discussed herein, the first portion 172 of the release mechanism 170 can be attached to the distal end 116 of the elongated shaft 110, and the second portion 174 of the release mechanism 170 can be fixedly attached to the proximal end of the medical device 130. The proximal release wire 120 and / or the distal release wire 122 can be slidably disposed within the lumen 112 of the elongated shaft 110, the first axial lumen of the first portion 172 of the release mechanism 170, and the second axial lumen of the second portion 174 of the release mechanism 170.

[0077] The method may include unlocking a retention mechanism between the proximal release wire 120 and the elongated shaft 110 to separate the proximal release wire 120 from the elongated shaft 110. The method may also include translating the proximal release wire 120 proximally away from the proximal end 114 of the elongated shaft 110 while the elongated shaft 110 is maintained in a fixed position relative to the treatment site, translating the proximal release wire 120 and / or the distal release wire 122 relative to the elongated shaft 110 and / or the release mechanism 170, thereby displacing the distal release wire 122 from the interlocked position to the released position, thereby releasing the medical device 130 from the elongated shaft 110.

[0078] The method may also include withdrawing the elongated shaft 110 and / or the microcatheter 190 distally from the treatment site. For example, in some embodiments, the elongated shaft 110 may be withdrawn proximally through the lumen 192 of the microcatheter 190 and removed, and then the microcatheter 190 may be withdrawn and / or removed from the patient's anatomy. In some embodiments, the elongated shaft 110 may be withdrawn proximally a sufficient distance so that the distal end 116 of the elongated shaft 110 and / or the first portion 172 of the release mechanism 170 are located within the distal end and / or lumen 192 of the microcatheter 190. The elongated shaft 110 and the microcatheter 190 may then be withdrawn together from the patient's anatomy.

[0079] In some embodiments, the elongated shaft 110 can be removed through the lumen 192 of the microcatheter 190, and the microcatheter 190 can be left and / or maintained in position within the patient's anatomy. If desired, a second elongated shaft and an associated second medical device can then be inserted into the proximal end of the lumen 192 of the microcatheter 190 and advanced to the treatment site for placement. The devices described herein and the method steps described herein can be used additional times as needed or desired for a particular procedure.

[0080] Fig.10 Aspects of another exemplary medical device system 200 are illustrated. Fig.10 216 of the distal end 216 of the elongated shaft 210. The medical device system 200 may include an elongated shaft 210 having an inner cavity 212 extending from the proximal end (not explicitly shown) of the elongated shaft 210 to the distal end 216 of the elongated shaft 210. The elongated shaft 210 may be similar in shape and function to the elongated shaft 110 described herein. In some embodiments, the elongated shaft 210 may be a catheter, a hypotube, or other similar tubular structure. In some embodiments, at least a portion of the elongated shaft 210 may include micromachining, multiple grooves or weakened areas, some degree of material removal, etc., to provide increased flexibility along the length of the elongated shaft 210 so as to pass through a tortuous vascular system. Some suitable but non-limiting materials (e.g., metal materials, polymer materials, composite materials, etc.) for the elongated shaft 210 are described below.

[0081] The medical device system 200 may include a proximal release wire (or delivery system pull wire) 220 and a distal release wire (or coupling pull wire) 222 slidably disposed within the lumen 212 of the elongated shaft 210. A medical device 230 may be disposed proximate to the distal end of the elongated shaft 210. The medical device 230 may be similar in shape and function to the medical device 130 described herein. The proximal and distal release wires 220, 222 may slide axially relative to the medical device 230 between an interlocked position and a released position, as will be described in greater detail herein. The proximal and distal release wires 220, 222 may be configured to releasably attach the medical device 230 to the distal end 216 of the elongated shaft 210.

[0082] The medical device 230 can be configured to expand from a delivery configuration to a placement configuration. The medical device 230 can be a vascular occlusion device, but other suitable medical devices that are transmitted, delivered, used, released, etc. in a similar manner are also conceivable, including but not limited to: embolic coils, stents, embolic filters, replacement heart valves, other occlusive devices and / or other medical implants, etc. In some embodiments, the proximal and / or distal release wires 220, 222 can be alternately and / or interchangeably referred to as pull wires, drive wires and / or locking wires. In some embodiments, the proximal and / or distal release wires 220, 222 can be generally solid wires or shafts, but can also be tubular. Some suitable but non-limiting materials (e.g., metal materials, polymer materials, composite materials, etc.) for the proximal and / or distal release wires 220, 222 are described below.

[0083] In some embodiments, the medical device system 200 may include a microcatheter 290 that is sized and configured to deliver a medical device in a delivery configuration to a treatment site. The elongated shaft 210 and the medical device 230 may be slidably disposed within a lumen 292 of the microcatheter 290. In some embodiments, the microcatheter 290 may facilitate percutaneous delivery of the medical device to a treatment site. Some suitable but non-limiting materials (e.g., metal materials, polymer materials, composite materials, etc.) for the microcatheter 290 are described below.

[0084] The proximal release line 220 extends distally from a proximal end (not explicitly shown) configured to remain outside the body to a distal end 226. In some cases, the distal end 226 of the proximal release line 220 may be located proximal to the medical device 230. The distal end 226 may be wound to form a plurality of helical turns 228a, 228b, 228c (collectively referred to as 228), thereby defining an inner cavity 234 extending therethrough. In other words, the wound distal end 226 may have a generally spring-like structure, wherein the inner cavity 234 extends through the winding portion. The wound distal end 226 may include any desired number (for example, but not limited to, less than one, one, two, three, four, or more) of helical turns 228. It is also contemplated that one or more helical turns 228 may form less than a full 360° turn. In some cases, one or more helical turns 228 may include a single turn having less than a full 360° turn.

[0085] The distal release line 222 extends distally from the proximal end 238 to the distal end 240. The distal end 240 of the distal release line 222 can be slidably coupled to the release mechanism 270, as will be described in more detail herein. The proximal end 238 can be generally located proximal to the distal end 226 of the proximal release line 220. For example, the proximal end 238 of the distal release line 222 can overlap a portion of the length of the distal end 226 of the proximal release line 220. The proximal end 238 can be wound to form a plurality of helical turns 242a, 242b, 242c (collectively referred to as 242), which define an inner cavity 244 extending therethrough. In other words, the wound proximal end 238 can have a generally spring-like structure, wherein the inner cavity 244 extends through the winding portion. The wound proximal end 238 can include any desired number of helical turns 242 (for example, but not limited to, less than one, two, three, four, or more). It is also contemplated that one or more of the spiral windings 242 may form less than a full 360° turn. In some cases, one or more of the spiral windings 242 may include a single winding having less than a full 360° turn.

[0086] In some embodiments, the coiled proximal end 238 and / or the coiled distal end 226 can be formed by using a metal pull wire and forming its ends into a coil or spiral. It is contemplated that some illustrative metals may include stainless steel, Nitinol, and others, as described in more detail below. If Nitinol is used, heat setting may be applied to form the coiled portion into the desired specific geometry.

[0087] The coiled distal end 226 of the proximal release line 220 can be slidably disposed on a linear portion 246 of the distal release line 222 located distal to the coiled proximal end 238, such that the linear portion 246 of the distal release line 222 is slidably disposed inside the lumen 234. The coiled proximal end 238 can be slidably disposed on a linear portion 236 of the proximal release line 220 located proximal to the coiled distal end 226, such that the linear portion 236 of the distal release line 222 is slidably disposed inside the lumen 244. This arrangement can form a sliding joint 260. In some cases, this configuration of the sliding joint 260 can reduce the risk of the sliding joint 260 sticking during delivery. The most distal winding 242c of the coiled proximal end 238 can be spaced a distance from the most proximal winding 228a of the coiled distal end 226 to provide a sliding joint gap 250. The sliding joint gap 250 can be a longitudinal distance that the proximal release line 220 can move (in at least the proximal direction) without simultaneously moving the distal release line 222. This can allow the proximal release line 220 to be slidably coupled to the distal release line 222 over a limited axial distance (e.g., along the longitudinal axis of the system 200). It is contemplated that the proximal release line 220 and the distal release line 222 can each move independently relative to each other over a limited axial distance. The sliding joint gap 250 can determine the distance that the proximal release line 220 and / or the distal release line 222 can slide independently before engaging with the other component 220, 222 and also causing it to move. The sliding joint gap 250 can be adjusted by changing the position of the proximal release line 220 relative to the distal release line 222 and fixing the proximal release line 220 to the position relative to the elongated shaft 210. In some cases, the slip joint gaps 250 may each have a length ranging from about 0.25 centimeters (cm) to about 3 cm, about 0.5 cm to about 2 cm, about 0.75 cm to about 1.25 cm, or about 1 cm. It is contemplated that, depending on the application, the slip joint gaps 250 may have a length less than 0.25 cm or greater than 3 cm.

[0088] The sliding arrangement of the proximal release wire 220 and the distal release wire 222 can help mitigate premature separation of the medical device 230. For example, when the delivery system 200 (and the medical device 230) is retracted proximally (and at other times during use), the elongated shaft 210 may be subjected to a tensile load. In other words, the distal portion of the elongated shaft 210 may stretch, which may cause the retention wire to separate from the medical device 230 prematurely. The proximal end (or an area adjacent thereto) of the proximal release wire 220 may be coupled to the proximal end (or an area adjacent thereto) of the elongated shaft 210 to limit or prevent movement of the proximal release wire 220 relative to the elongated shaft. However, this may cause the distal release wire 222 to stretch along with the elongated shaft 210. The sliding arrangement of the proximal release wire 220 and the distal release wire 221 may allow the proximal release wire 220 to move proximally (e.g., stretch) as the distal portion of the elongated shaft 210 stretches without applying a proximally directed force to the distal release wire 222. For example, if the proximal release line 220 and the distal release line 222 can be arranged so that the most distal coil 242c wrapped around the proximal end 238 can be spaced a distance from the most proximal coil 228a wrapped around the distal end 226. This can allow the proximal release line 220 to move proximally the entire length of the sliding joint gap 250 before a proximal force is applied to the distal release line 222. Once the most proximal coil 228a wrapped around the distal end 226 engages the most distal coil 242c wrapped around the proximal end 238, the distal release line 222 moves proximally with the proximal release line 220, as will be described in more detail herein.

[0089] In use, the microcatheter 290 of the medical device system 200 can be inserted into the patient's anatomical structure, and the distal end of the microcatheter 290 can be guided and / or advanced to a position adjacent to the treatment site. The medical device 230 disposed at and / or adjacent to the distal end 216 of the elongated shaft 210 can be inserted into the proximal end of the lumen 292 disposed inside the microcatheter 290, and passed through and / or advanced with the microcatheter 290 to the treatment site. In some embodiments, the medical device 230 can be disposed inside the lumen 292 of the microcatheter 290 and adjacent to the distal end of the microcatheter 290. In some embodiments, the medical device 230 can be disposed inside the lumen 292 of the microcatheter 290 and adjacent to the distal end of the microcatheter 290 before use and / or before the microcatheter 290 is inserted into the patient's anatomical structure. The placement and / or release of the medical device 230 can be selectively performed according to the type of medical device and / or the desired treatment process or method. When the medical device 230 is ready to be placed, the elongated shaft 210 can be advanced and / or translated distally relative to the microcatheter 290 until the medical device 230 is exposed and / or disposed distally of the microcatheter 290. Alternatively, the microcatheter 290 is retracted relative to the elongated shaft 210 until the medical device 230 is exposed and / or disposed distally of the microcatheter 290. For clarity, the microcatheter 290 is illustrated in a proximally retracted configuration. However, it should be understood that the microcatheter can be disposed above the medical device 230 during guidance through the body.

[0090] The release mechanism 270 can releasably attach the medical device 230 to the distal end 216 of the elongated shaft 210. In some embodiments, the elongated shaft 210 can include a first portion 272 of the release mechanism 270 fixedly attached to the distal end 216 of the elongated shaft 210, and the medical device 230 can include a second portion 274 of the release mechanism 270 fixedly attached to the proximal end of the medical device 230. The distal end 240 of the distal release line 222 can be slidably engaged with the first portion 272 of the release mechanism 270 and the second portion 274 of the release mechanism 270 in an interlocked position, such as in Fig.10 When the proximal release line 220 and the distal release line 222 are in the delivery configuration, the distal release line 222 interlocks the first portion 272 of the release mechanism 270 with the second portion 274 of the release mechanism 270, as shown in FIG. Figure 4 As seen in.

[0091] When the delivery system 200 is advanced distally to the treatment location, the elongated shaft 210 may begin to extend. In some cases, the proximal release wire 220 may be coupled to the elongated shaft 210 to prevent longitudinal movement of the proximal release wire 220 relative to the elongated shaft 210 during delivery. This may cause the proximal release wire 220 to extend along with the elongated shaft 210. Although not explicitly shown, when the proximal release wire 220 is displaced in the proximal direction, the distal release wire 222 may remain longitudinally fixed and thus reduce the distance of the sliding joint gap 250.

[0092] When detachment of the medical device 230 is desired, the user may separate the elongated shaft 210 from the proximal release wire 220 (if attached) to allow proximal retraction of the proximal release wire 220. The proximal end of the proximal release wire 220 may be proximally driven over a first distance (not explicitly shown) until the length of the gap 250 of the sliding joint 260 has been exhausted. It is contemplated that the length of the gap 250 may be variable depending on the degree of stretching of the elongated shaft 210 and / or the initial configuration of the coiled distal end 226 relative to the coiled proximal end 238. Once the proximal-most coil 228a of the proximal release wire 220 engages the distal-most coil 242c of the distal release wire 222, further proximal movement of the proximal release wire 220 a second distance (e.g., beyond the predetermined distance of the gap or greater than the first distance) causes the distal release wire 222 to be proximally actuated with the proximal release wire 220. In some cases, the coiled proximal end 238 of the distal release wire 222 can have an interference fit (or frictionally engage) with the inner wall of the elongated shaft 210. This can secure the distal release wire 222 until a user intentionally applies a force to the proximal release wire 220. This arrangement can help reduce passive migration of the distal release wire 222.

[0093] It is contemplated that the release mechanism 270 may remain in the interlocked configuration until the distal release wire 222 has been proximally driven a length equal to or greater than the length of the release mechanism 270. For example, actuating the distal release wire 222 proximally a length less than the length of the release mechanism 270 may not be sufficient to release the medical device 230. In at least some embodiments, the distal release wire 222 may be slidably disposed within the lumen 212 extending through the elongated shaft 210, a first axial lumen extending through the first portion 272 of the release mechanism 270, and a second axial lumen extending through the second portion 274 of the release mechanism 270. It is contemplated that the release of the medical device 230 may be reversed at any axial position of the distal release wire 222 between the interlocked configuration and the fully released configuration. When the medical device 230 is releasably attached to the distal end 216 of the elongated shaft 210, the first axial lumen of the first portion 272 and the second axial lumen of the second portion 274 may be substantially coaxial with the longitudinal center axis and / or the distal release wire 222. Some suitable but non-limiting materials (eg, metal materials, polymer materials, composite materials, etc.) for the release mechanism 270 , the first portion 272 , and the second portion 274 are described below.

[0094] The elongated shaft 210 can have a sufficient length so that when the medical device 230 is disposed distally of the microcatheter 290, the proximal end of the elongated shaft 210 and / or the proximal release wire 220 is still distally of the microcatheter 290 (e.g., extending proximally therefrom). In use, the elongated shaft 210 can have a sufficient length to reach a position outside the patient from the treatment site where the medical device system 200 can be manipulated by an operator (e.g., a clinician, a doctor, a user, etc.). After inserting the medical device system 200 into the treatment site, the operator of the medical device system 200 can place a first hand at the proximal end of the elongated shaft 210 and a second hand at the proximal end of the proximal release wire 220, thereby manipulating the proximal release wire 220 and / or the distal release wire 222 to release the medical device 230.

[0095] Although not explicitly shown, the medical device system 200 may include an introducer, which may be a tubular member having an inner cavity extending from a proximal end to a distal end, configured to load the medical device 230 into the microcatheter 290. The introducer may hold the medical device 230 to a reduced diameter and / or in a delivery configuration for loading into the microcatheter 290. After the medical device 230 is loaded into the microcatheter 290, the introducer may be retracted proximally above and relative to the elongated shaft 210 and removed from the medical device system 200.

[0096] In use, a method of delivering a medical device 230 to a treatment site (e.g., a vein, an artery, etc.) may include inserting a microcatheter 290 into an anatomical structure of a patient and then guiding the distal end of the microcatheter 29 to a position adjacent to the treatment site. The method may include inserting the medical device 230 disposed at and / or proximate to the distal end 216 of the elongated shaft 210 into the proximal end of a lumen 292 disposed within the microcatheter 290. In some embodiments, after the microcatheter 290 is inserted into the anatomical structure of the patient, the medical device 230 may be inserted into the lumen 292 of the microcatheter 290. The method may include advancing the medical device 230 through the microcatheter 290 to the treatment site. The medical device 230 may be releasably attached to the distal end 216 of the elongated shaft 210 by a pull wire (e.g., a proximal release wire 220 and / or a distal release wire 222, etc.) extending through the lumen 112 within the elongated shaft 210. The proximal release wire 220 may extend proximally from the elongated shaft 210, and the proximal release wire 220 may be releasably coupled to the elongated shaft 210. Alternatively, in some embodiments, the medical device 230 may be inserted into the proximal end of the lumen 292 of the microcatheter 290 and then advanced through the microcatheter 290 to the distal end of the microcatheter 290 before the microcatheter 290 is inserted into the patient's anatomical structure.

[0097] As discussed herein, the first portion 272 of the release mechanism 270 can be attached to the distal end 216 of the elongated shaft 210, and the second portion 274 of the release mechanism 270 can be fixedly attached to the proximal end of the medical device 230. The proximal release wire 220 and / or the distal release wire 222 can be slidably disposed within the lumen 112 of the elongated shaft 210, the first axial lumen of the first portion 272 of the release mechanism 270, and the second axial lumen of the second portion 274 of the release mechanism 270.

[0098] The method may include unlocking a retaining mechanism between the proximal release wire 220 and the elongated shaft 210 to separate the proximal release wire 220 from the elongated shaft 210. The method may also include translating the proximal release wire 220 proximally from the proximal end of the elongated shaft 210 while maintaining the elongated shaft 210 in a fixed position relative to the treatment site to translate the proximal release wire 220 and / or the distal release wire 222 relative to the elongated shaft 210 and / or the release mechanism 270 to convert the distal release wire 222 from the interlocked position to the released position, thereby releasing the medical device 230 from the elongated shaft 210.

[0099] The method may also include retracting the elongated shaft 210 and / or the microcatheter 290 proximally from the treatment site. For example, in some embodiments, the elongated shaft 210 may be retracted proximally through the lumen 292 of the microcatheter 290 and removed, and then the microcatheter 290 may be retracted and / or removed from the patient's anatomy. In some embodiments, the elongated shaft 210 may be retracted proximally a sufficient distance so that the distal end 216 of the elongated shaft 210 and / or the first portion 272 of the release mechanism 270 are located at the distal end of the microcatheter 290 and / or within the lumen 292. The elongated shaft 210 and the microcatheter 290 may then be retracted together from the patient's anatomy.

[0100] In some embodiments, the elongated shaft 210 can be removed through the lumen 292 of the microcatheter 290, and the microcatheter 290 can be left and / or maintained within the patient's anatomy. If desired, a second elongated shaft and an associated second medical device can then be inserted into the proximal end of the lumen 292 of the microcatheter 290 and advanced to the treatment site for placement. Additional iterations of the apparatus described herein and the method steps described can be used as needed or as desired with respect to specific steps.

[0101] The materials that can be used for the various components and their various elements of the medical device systems 100, 200, elongated shafts 110, 210, release wires 120, 122, 220, 222, medical devices 130, release mechanisms 170, introducers and / or microcatheters 190, 290, etc. disclosed herein (and / or other systems disclosed herein) may include materials commonly associated with medical devices. For simplicity, the following discussion refers to the medical device systems 100, 200, elongated shafts 110, 210, release wires 120, 122, 220, 222, medical devices 130, release mechanisms 170, introducers and / or microcatheters 190, 290, etc. However, this is not intended to limit the devices and methods described herein, as the discussion may also apply to other elements, components, parts, or devices disclosed herein, such as but not limited to medical device systems 100, 200, slender shafts 110, 210, release lines 120, 122, 220, 222, medical devices 130, release mechanisms 170, introducers, and / or microcatheters 190, 290, etc. and / or their elements or parts.

[0102] In some embodiments, the medical device system 100, 200, the elongated shaft 110, 210, the release wire 120, 122, 220, 222, the medical device 130, the release mechanism 170, the introducer, and / or the microcatheter 190, 290, etc. and / or their components can be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, a combination thereof, or other suitable materials. Some examples of suitable metals and metal alloys include: stainless steel, such as 444V, 444L and 314LV stainless steel; low carbon steel; nickel-titanium alloys (such as linear elastic and / or superelastic nitinol); other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as 625, UNS: N06022 UNS:N10276 other alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, etc.), 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, etc.), etc.), nickel-molybdenum alloys (e.g., UNS: N10665, etc.), alloy ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (for example, UNS: R44003 such as etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0103] As mentioned herein, within the family of commercially available nickel-titanium or Nitinol alloys are classes designated as "linear elastic" or "non-superelastic," which, while chemically similar to conventional shape memory and superelastic species, may exhibit unique and useful mechanical properties. Linear elastic and / or non-superelastic Nitinol may be distinguished from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol does not exhibit a distinct "superelastic plateau" or "signal zone" in its stress / strain curve as does superelastic Nitinol. In contrast, in linear elastic and / or non-superelastic Nitinol, as recoverable strain increases, stress continues to increase in a generally linear, or slightly but not necessarily completely linear, relationship until plastic deformation begins or at least increases in a more linear relationship than the superelastic plateau and / or sign zone seen in superelastic Nitinol. Therefore, for purposes of this disclosure, linear elastic and / or non-superelastic Nitinol may also be referred to as "generally" linear elastic and / or non-superelastic Nitinol.

[0104] In some cases, linear elastic and / or non-superelastic Nitinol may also be distinguished from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol may accept strains up to about 2-5% while still being significantly elastic (e.g., before plastic deformation occurs), whereas superelastic Nitinol may accept strains up to about 8% before plastic deformation occurs. These two materials may be distinguished from other linear elastic materials such as stainless steel, which may accept only about 0.2 to 0.44% strain before plastic deformation occurs (which may also be distinguished based on their composition).

[0105] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not show any martensite / austenite phase transformation detectable over a wide temperature range by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA). For example, in some embodiments, in the linear elastic and / or non-superelastic nickel-titanium alloy, there may be no martensite / austenite phase transformation detectable by DSC and DMTA analysis in the range of about -60 degrees Celsius (°C) to about 120°C. Therefore, the mechanical bending properties of this material are generally inert to the effects of temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of the linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are approximately the same as the mechanical properties at body temperature, for example, they do not show superelastic plateaus and / or sign areas. For example, over the entire wide temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or performance.

[0106] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy can be nickel in the range of about 50 to about 60 weight percent, with the remainder being essentially titanium. In some embodiments, the combination is nickel in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is the FHP-NT alloy available from Furukawa Technical Materials, Inc., Kanagawa, Japan. Other suitable materials may include ULTANIUMTM (available from Neo-Metrics) and GUM METALTM (available from Toyota). In some other embodiments, superelastic alloys (e.g., superelastic Nitinol) may be used to obtain the desired properties.

[0107] In at least some embodiments, some or all of the medical device systems 100, 200, the elongated shafts 110, 210, the release wires 120, 122, 220, 222, the medical devices 130, 230, the release mechanisms 170, 270, the introducers, and / or the microcatheters 190, 290, etc., and / or their components may also be doped with, made of, or include radiopaque materials. Radiopaque materials are understood to be materials that can produce a relatively bright image on a fluoroscopic screen or another imaging technique during a medical procedure. This relatively bright image helps the user determine the position of the medical device systems 100, 200, the elongated shafts 110, 210, the release wires 120, 122, 220, 222, the medical devices 130, 230, the release mechanisms 170, 270, the introducers, and / or the microcatheters 190, 290, etc. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, etc. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device system 100, 200, the elongated shaft 110, 210, the release wire 120, 122, 220, 222, the medical device 130, 230, the release mechanism 170, 270, the introducer and / or microcatheter 190, 290, etc. to achieve the same results.

[0108] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the medical device system 100, 200, the elongated shaft 110, 210, the release wire 120, 122, 220, 222, the medical device 130, 230, the release mechanism 170, 270, the introducer, and / or the microcatheter 190, 290, etc. For example, the medical device system 100, 200, the elongated shaft 110, 210, the release wire 120, 122, 220, 222, the medical device 130, 230, the release mechanism 170, 270, the introducer and / or the microcatheter 190, 290, etc., and / or components or portions thereof can be made of a material that does not significantly distort the image and produce noticeable artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may be unsuitable because they may produce artifacts in MRI images. The medical device system 100, 200, the elongated shaft 110, 210, the release wire 120, 122, 220, 222, the medical device 130, 230, the release mechanism 170, 270, the introducer and / or microcatheter 190, 290, etc., or portions thereof may also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003 such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, etc.), etc.), Nitinol etc., and others.

[0109] In some embodiments, the medical device system 100, 200, the elongated shaft 110, 210, the release wire 120, 122, 220, 222, the medical device 130, 230, the release mechanism 170, 270, the introducer, and / or the microcatheter 190, 290, etc., and / or portions thereof may be made of or include a polymer or other suitable material. Some examples of suitable polymers may include: polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, such as available from Dupont Corporation) ), polyetherester block copolymers, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., available from DSM Engineering Plastics ), ether or ester based copolymers (e.g., butylene / alkylene phthalate and / or other polyester elastomers, such as those available from Dopont Corporation ), polyamide (e.g., available from Bayer Or available from Elf Atochem ), elastomeric polyamides, polyamide / polyether block copolymers, polyether block amides (PEBA, for example, available under the trade name purchased), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), High density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyphenylene terephthalamide (e.g., ), polysulfone, nylon, nylon-12 (such as available from EMS American Grilon Company ), perfluoropropyl vinyl ether (PFA), ethylene-vinyl alcohol copolymer, polyolefin, polystyrene, epoxy resin, polyvinylidene chloride (PVdC), (styrene-b-isobutylene-b-styrene) triblock copolymer (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomer, biocompatible polymer, other suitable materials, or mixtures, compositions, copolymers, polymer / metal composites thereof, etc. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0110] In some embodiments, the medical device systems 100, 200, elongated shafts 110, 210, release lines 120, 122, 220, 222, medical devices 130, 230, release mechanisms 170, 270, introducers and / or microcatheters 190, 290, etc. disclosed herein may include a fiber material disposed above or within the structure. The fiber material may be composed of a biocompatible material, such a polymer material or a biological material suitable for ingrowth into tissue. In some embodiments, the fiber material may include a bioabsorbable material. Some examples of suitable fiber materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials (such as polyethylene, polypropylene), polyesters, polyurethanes, and / or blends or combinations thereof.

[0111] In some embodiments, the medical device system 100, 200, the elongated shaft 110, 210, the release line 120, 122, 220, 222, the medical device 130, 230, the release mechanism 170, 270, the introducer and / or microcatheter 190, 290, etc. may include and / or be composed of a textile material. Some examples of suitable textile materials may include synthetic yarns, which may be straight, shaped, twisted, textured, pre-shrunk or unshrunk. Synthetic biocompatible yarns suitable for use in the present invention include, but are not limited to: polyesters (including polyethylene terephthalate (PET) polyesters), polypropylenes, polyethylenes, polyurethanes, polyolefins, ethylene polymers, polymethacrylates, polyamides, naphthalene dicarboxylic acid derivatives, silk, and polytetrafluoroethylene. In addition, at least one of the synthetic yarns may be a metal yarn or a glass or ceramic yarn or fiber. Useful metallic yarns include yarns made of stainless steel, platinum, gold, titanium, tantalum or alloys based on Ni-Co-Cr or containing these materials. These yarns may also include carbon, glass or ceramic fibers. Ideally, these yarns are made of thermoplastic materials, including but not limited to polyesters, polypropylenes, polyethylenes, polyurethanes, polynaphthalenes, polytetrafluoroethylenes, etc. These yarns may belong to multifilaments, monofilaments or be spun into types. The type and fineness of the selected yarn may be selected in a manner to form biocompatibility and implantable prostheses (more specifically, vascular structures with desirable properties).

[0112] In some embodiments, the medical device systems 100, 200, the elongated shafts 110, 210, the release wires 120, 122, 220, 222, the medical devices 130, 230, the release mechanisms 170, 270, the introducers and / or microcatheters 190, 290, etc. may contain and / or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include: antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrorotatory phenylalanine proline arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptides, monoclonal antibodies capable of preventing smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalazine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (such as D-Phe-Pro-Arg chloro Methyl ketone (a compound containing an RGD peptide), heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies to growth factors, bifunctional molecules composed of growth factors and cytotoxins, bifunctional molecules composed of antibodies and cytotoxins); cholesterol-lowering agents; vasodilators; and drugs that interfere with endogenous vasoactive mechanisms.

[0113] It should be understood that the present disclosure is in many respects illustrative only. Changes may be made in the details, particularly in shape, size, and arrangement of steps, without exceeding the scope of the invention. This may include, within appropriate limits, using any feature of one exemplary embodiment for other embodiments. Of course, the scope of the invention is defined by the language in which the appended claims are expressed.

Claims

1. A medical device system, comprising: an elongated shaft having a lumen extending from a proximal end of the elongated shaft to a distal end of the elongated shaft; a proximal release line extending distally from a proximal end configured to remain outside the body to a distal end and slidably disposed within the lumen of the elongated shaft; as well as a distal release wire extending distally from the proximal end to the distal end and slidably disposed within the lumen of the elongated shaft, the proximal end of the distal release wire slidably coupled to the distal end of the proximal release wire, wherein the distal release wire is configured to releasably attach a medical device to the distal end of the elongated shaft, The distal end of the proximal release line is formed as a proximal loop, the proximal end of the distal release line is formed as a distal loop, the proximal loop is slidably connected to the distal loop, and when the proximal release line is actuated proximally, the inner surface of the distal end of the proximal loop is configured to engage with the inner surface of the proximal end of the distal loop.

2. The medical device system of claim 1, wherein the distal ring is configured to frictionally fit with an inner surface of the elongated shaft.

3. The medical device system of claim 1, wherein the proximal ring extends generally parallel to the first plane.

4. The medical device system of claim 3, wherein the distal ring extends generally parallel to a second plane, the second plane being generally perpendicular to the first plane.

5. The medical device system of any one of claims 1 to 4, wherein the proximal release line is configured to move proximally a predetermined axial distance along the longitudinal axis of the elongated shaft independently of the distal release line.

6. The medical device system of claim 5, wherein proximal movement of the proximal release line greater than the predetermined axial distance causes the distal release line to move in unison with the proximal release line.

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