阅读说明：本技术 医疗设备释放系统 (Medical device release system ) 是由 尼古拉斯·L·塔索尼 埃里克·丁格斯 凯文·麦康奈尔 于 2019-02-01 设计创作，主要内容包括：医疗设备系统可以包括细长轴,其具有从近端延伸到远端的腔,设置在细长轴的腔内的释放线,该释放线被配置成将医疗设备可释放地附接到细长轴的远端,以及固定构件,其固定附接到细长轴的近端和释放线的近端。固定构件的近侧部分可以被配置成将细长轴保持在固定位置的同时,在对固定构件的近侧部分施加指向近侧的力时,远离细长轴的近端向近侧地平移,其中近侧部分在远离细长轴的近端向近侧地平移后,保持与细长轴的近端连接。(The medical device system may include an elongate shaft having a lumen extending from a proximal end to a distal end, a release wire disposed within the lumen of the elongate shaft, the release wire configured to releasably attach a medical device to the distal end of the elongate shaft, and a securing member fixedly attached to the proximal end of the elongate shaft and the proximal end of the release wire. The proximal portion of the fixation member may be configured to translate proximally away from the proximal end of the elongate shaft upon application of a proximally directed force to the proximal portion of the fixation member while maintaining the elongate shaft in the fixed position, wherein the proximal portion remains coupled to the proximal end of the elongate shaft after translating proximally away from the proximal end of the elongate shaft.)

1. A medical device system, comprising:

an elongate shaft having a lumen extending from a proximal end of the elongate shaft to a distal end of the elongate shaft;

a release wire disposed within the lumen of the elongate shaft, wherein the release wire is configured to releasably attach a medical device to a distal end of the elongate shaft; and

a securing member fixedly attached to the proximal end of the elongate shaft and the proximal end of the release wire;

wherein the proximal portion of the fixation member is configured to translate proximally away from the proximal end of the elongate shaft while the elongate shaft remains in a fixed position upon application of a proximally directed force to the proximal portion of the fixation member;

wherein the proximal portion remains coupled to the proximal end of the elongate shaft after proximal translation away from the proximal end of the elongate shaft.

2. The medical device system of claim 1, wherein a proximal portion of the fixation member is fixedly attached to a proximal end of the release wire and a distal portion of the fixation member is fixedly attached to a proximal end of the elongate shaft.

3. The medical device system of claim 2, wherein the distal portion of the fixation member is a coil spring.

4. The medical device system of claim 3, wherein the coil spring is configured to bias the proximal portion of the fixation member distally toward the proximal end of the elongate shaft.

5. The medical device system of claim 4, wherein the helical spring is elastically deformed during proximal translation of the proximal portion of the fixation member to a predetermined axial position.

6. The medical device system of claim 5, wherein upon release of the proximal portion of the fixation member after proximally translating the proximal portion of the fixation member to the predetermined axial position, the coil spring distally translates the proximal portion of the fixation member toward the proximal end of the elongate shaft.

7. The medical device system of claim 5, wherein the helical spring is plastically deformed upon proximal translation of the proximal portion of the fixation member axially past the predetermined axial position.

8. The medical device system of claim 7, wherein the axial position of the proximal portion of the fixation member remains substantially fixed relative to the proximal end of the elongate shaft upon release of the proximal portion of the fixation member after the proximal portion of the fixation member translates proximally axially past the predetermined axial position.

9. The medical device system of any of claims 1-8, wherein proximal translation of the proximal portion of the fixation member away from the proximal end of the elongate shaft axially translates the release wire relative to the elongate shaft.

10. The medical device system of any of claims 1-9, wherein a proximal portion of the fixation member is visually distinguishable from the elongate shaft.

11. The medical device system of any of claims 1-10, further comprising:

a medical device disposed proximate the distal end of the elongate shaft, wherein the release wire releasably secures the medical device to the distal end of the elongate shaft; and

a microcatheter configured to deliver the medical device to a treatment site, the elongate shaft and the medical device being slidably disposed within a lumen of the microcatheter.

12. The medical device system of claim 11, wherein the distal portion of the fixation member is disposed proximal to the microcatheter when the medical device is disposed distal to the microcatheter.

13. The medical device system of any of claims 11-12, wherein the proximal portion of the fixation member assumes a non-linear configuration when unconstrained.

14. The medical device system of any of claims 11-13, wherein the elongate shaft comprises a first portion of a release mechanism attached to a distal end of the elongate shaft and the medical device comprises a second portion of a release mechanism attached to a proximal end of the medical device;

wherein the release line interlocks the first portion of the release mechanism and the second portion of the release member when the proximal portion of the fixation member is biased distally by the distal portion of the fixation member.

15. The medical device system of any of claims 11-14, further comprising:

an introducer configured to load the medical device into the microcatheter;

wherein proximal withdrawal of the introducer over the fixation member positions a proximal portion of the fixation member in a substantially linear configuration while the proximal portion is disposed within the introducer.

Technical Field

The present invention relates to medical devices and methods for making and/or using medical devices. More particularly, the present invention relates to a system configuration for releasing a medical implant.

Background

A wide variety of in vivo medical devices have been developed for medical use, e.g., surgical and/or intravascular use. Some of these devices include medical leads, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured by any of a variety of different manufacturing methods and may be used according to 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.

Disclosure of Invention

In a first aspect, a medical device system may include an elongate shaft having a lumen extending from a proximal end of the elongate shaft to a distal end of the elongate shaft; a release wire disposed within the lumen of the elongate shaft, wherein the release wire is configured to releasably attach a medical device to the distal end of the elongate shaft; and a securing member fixedly attached to the proximal end of the elongate shaft and the proximal end of the release wire. The proximal portion of the fixation member may be configured to translate proximally away from the proximal end of the elongate shaft while the elongate shaft remains in a fixed position upon application of a proximally directed force to the proximal portion of the fixation member. The proximal portion remains coupled to the proximal end of the elongate shaft after translating proximally away from the proximal end of the elongate shaft.

Additionally or alternatively, and in a second aspect, a proximal portion of the fixation member is fixedly attached to the proximal end of the release wire and a distal portion of the fixation member is fixedly attached to the proximal end of the elongate shaft.

Additionally or alternatively, and in a third aspect, the distal portion of the fixation member is a coil spring.

Additionally or alternatively, and in a fourth aspect, the coil spring is configured to bias the proximal portion of the fixation member distally toward the proximal end of the elongate shaft.

Additionally or alternatively, and in a fifth aspect, the helical spring is elastically deformed during proximal translation of the proximal portion of the fixation member to the predetermined axial position.

Additionally or alternatively, and in a sixth aspect, upon release of the proximal portion of the fixation member after proximally translating the proximal portion of the fixation member to the predetermined axial position, the helical spring distally translates the proximal portion of the fixation member toward the proximal end of the elongate shaft.

Additionally or alternatively, and in a seventh aspect, the helical spring is plastically deformed after the proximal portion of the fixation member axially passes a predetermined axial position.

Additionally or alternatively, and in an eighth aspect, upon release of the proximal portion of the fixation member after proximal translation of the proximal portion of the fixation member axially past the predetermined axial position, the axial position of the proximal portion of the fixation member remains substantially fixed relative to the proximal end of the elongate shaft.

Additionally or alternatively, and in a ninth aspect, proximal translation of the proximal portion of the fixation member away from the proximal end of the elongate shaft axially translates the release wire relative to the elongate shaft.

Additionally or alternatively, and in a tenth aspect, the proximal portion of the fixation member is visually distinguishable from the elongate shaft.

Additionally or alternatively, and in an eleventh aspect, a medical device system can include an elongate shaft having a lumen extending from a proximal end of the elongate shaft to a distal end of the elongate shaft; a medical device disposed proximate to a distal end of the elongate shaft; a release wire disposed within the lumen of the elongate shaft, wherein the release wire releasably secures the medical device to the distal end of the elongate shaft; a securing member fixedly attached to the proximal end of the elongate shaft and the proximal end of the release wire; and a microcatheter configured to deliver a medical device to the treatment site, the elongate shaft and the medical device being slidably disposed within a lumen of the microcatheter. The proximal portion of the fixation member may be configured to translate proximally away from the proximal end of the elongate shaft while the elongate shaft remains in a fixed position upon application of a proximally directed force to the proximal portion of the fixation member. The proximal portion remains coupled to the proximal end of the elongate shaft after translating proximally away from the proximal end of the elongate shaft.

Additionally or alternatively, and in a twelfth aspect, when the medical device is disposed distal of the microcatheter, the distal portion of the fixation member is disposed proximal of the microcatheter.

Additionally or alternatively, and in a thirteenth aspect, when unconstrained, the proximal portion of the fixation member assumes a non-linear configuration.

Additionally or alternatively, and in a fourteenth aspect, the elongate shaft comprises a first portion of the release mechanism attached to the distal end of the elongate shaft, and the medical device comprises a second portion of the release mechanism attached to the proximal end of the medical device;

wherein the release wire may interlock the first portion of the release mechanism and the second portion of the release member when the proximal portion of the fixation member is biased distally by the distal portion of the fixation member.

Additionally or alternatively, and in a fifteenth aspect, the medical device system may further comprise an introducer configured to load the medical device into the microcatheter. Proximal withdrawal of the introducer over the fixation member positions the proximal portion of the fixation member in a substantially linear configuration while the proximal portion is disposed within the introducer.

Additionally or alternatively, and in a sixteenth aspect, a method of delivering a medical device to a treatment site may comprise:

inserting a microcatheter into the patient's anatomy and guiding a distal end of the microcatheter to a position adjacent the treatment site;

inserting a medical device disposed at a distal end of an elongate shaft into a proximal end of a lumen disposed within a microcatheter;

wherein the medical device is releasably attached to the distal end of the elongate shaft by a pull wire extending through a lumen within the elongate shaft, and wherein a fixation member extends proximally from the elongate shaft, the fixation member being fixedly attached to the elongate shaft and the pull wire;

advancing a medical device through a microcatheter to a treatment site;

the proximal portion of the fixation member is translated proximally away from the proximal end of the elongate shaft while the elongate shaft remains in the fixation position to translate the pull wire relative to the elongate shaft to release the medical device from the elongate shaft.

Wherein the proximal portion of the fixation member remains coupled to the proximal end of the elongate shaft after proximal translation away from the proximal end of the elongate shaft.

Additionally or alternatively, and in a seventeenth aspect, a proximal portion of the fixation member is fixedly attached to the pull wire and a distal portion of the fixation member is fixedly attached to the elongate shaft.

Additionally or alternatively, and in an eighteenth aspect, a first portion of the release mechanism is attached to the distal end of the elongate shaft and a second portion of the release mechanism is attached to the proximal end of the medical device.

Additionally or alternatively, and in a nineteenth aspect, the pull wire is slidably disposed within the distal portion of the fixation member, the elongate shaft, the first portion of the release mechanism, and the second portion of the release mechanism.

Additionally or alternatively, and in a second aspect, upon release of the proximal portion of the fixation member after proximal translation of the proximal portion of the fixation member to the predetermined axial position, the proximal portion of the fixation member is biased toward the proximal end of the elongate shaft. After proximal translation of the proximal portion of the fixation member axially past the predetermined axial position, the axial position of the proximal portion of the fixation member remains substantially fixed relative to the proximal end of the elongate shaft upon release of the proximal portion of the fixation member.

The above summary of some embodiments, aspects, and/or examples is not intended to describe each embodiment or every implementation of the present invention. The figures and the detailed description that follow more particularly exemplify these embodiments.

Drawings

The present invention may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings,

wherein:

FIG. 1 is a perspective view of an exemplary medical device system;

FIG. 2 is a partial cross-sectional view of an exemplary medical device system;

FIG. 3 is a partial cross-sectional view of a portion of an exemplary medical device system;

FIG. 4 is a partial cross-sectional view of a portion of an exemplary medical device system;

5-6 illustrate actuation of a portion of an exemplary medical device system;

FIG. 7 illustrates an exemplary release mechanism of an exemplary medical device system; and

fig. 8-9 illustrate an exemplary fixation member during loading of an exemplary medical device system.

While aspects of the invention are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit aspects of the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

Detailed Description

The following description should be read with reference to the drawings, which are not necessarily drawn to scale, wherein like reference numerals designate like elements in the several views. The detailed description and drawings are intended to be illustrative of, but not limiting to, the claimed invention. Those of ordinary skill in the art will recognize that the various elements described and/or illustrated may be arranged in various combinations and configurations without departing from the scope of the disclosure. The detailed description and drawings illustrate exemplary embodiments of the claimed invention. However, for clarity and ease of understanding, although each feature and/or element may not be shown in each figure, the features and/or elements may be understood to be present anyway unless otherwise indicated.

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

All numerical values are herein assumed to be modified by the term "about," whether or not explicitly indicated. The term "about," in the context of numerical values, generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure. Unless otherwise indicated, other uses of the term "about" (e.g., in contexts other than numerical) may be presumed to have its ordinary and customary definition, as the context of the specification is understood and consistent with the context of the specification.

The recitation of logarithmic ranges by endpoints includes all numbers subsumed within that range and includes the endpoints (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

Although some suitable dimensions, ranges, and/or values are disclosed in connection with various components, features, and/or specifications, one skilled in the art will appreciate, in light of the present disclosure, that desired dimensions, ranges, and/or values may deviate from the explicitly disclosed dimensions, ranges, and/or values.

As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. It should be noted that certain features of the disclosure may be described in the singular for ease of understanding, even though these features may be in the plural or repeated in the disclosed embodiments. Each instance of a feature may include and/or be encompassed by a singular disclosure unless expressly stated to the contrary. For simplicity and clarity, not all elements of the disclosed invention are necessarily shown in each figure or discussed in detail below. However, it will be understood that the following discussion may be equally applicable to any and/or all elements, where there is more than one element, unless explicitly stated to the contrary. Moreover, for purposes of clarity, not every instance of a component or feature may be shown in every drawing.

Relative terms such as "proximal", "distal", "advance", "retract", variants thereof, and the like, may generally contemplate the positioning, orientation, and/or operation of various elements relative to a user/operator of the device, where "proximal" and "retract" mean or refer to being closer to or toward the user, and "distal" and "advance" mean or refer to being further from or away from the user. In certain instances, the terms "proximal" and "distal" may be arbitrarily designated to facilitate understanding of the present invention, and such illustrations will be readily apparent to those skilled in the art. Other relative terms, such as "upstream," "downstream," "inflow," and "outflow," refer to the direction of fluid flow within a lumen, such as a body cavity, vessel, or device. Still other relative terms, such as "axial," "circumferential," "longitudinal," "lateral," "radial," and/or the like, and/or variations thereof, generally refer to a direction and/or orientation relative to a central longitudinal axis of the disclosed structure or device.

The term "range" is understood to mean the largest measurement of the stated or determined dimension unless specifically mentioned as the smallest range. For example, "outboard extent" may be understood to refer to the maximum outboard dimension, "radial extent" may be understood to refer to the maximum radial dimension, "longitudinal extent" may be understood to refer to the maximum longitudinal dimension, and the like. Each instance of a "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.), and will be apparent to one skilled in the art from the context of the respective use. In general, a "range" may be considered to be the largest possible dimension measured according to the intended use. However, in the case of being referred to as a "minimum range," range "shall refer to the smallest possible dimension as measured by the intended use. In some cases, "range" may be measured orthogonally in a plane and/or cross-section in general, but may be measured differently-such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), and the like, as will be apparent from the particular context.

It is noted that references in the specification to "one embodiment," "some embodiments," "other embodiments," or the like, indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are considered to be combinable or arrangeable with each other to form other additional embodiments or to supplement and/or enrich the described embodiments as would be understood by one of ordinary skill in the art.

For purposes of clarity, certain identifying numerical nomenclature (e.g., first, second, third, fourth, etc.) may be used throughout the description and/or claims to name and/or distinguish various described and/or claimed features. It is to be understood that numerical nomenclature is not intended to be limiting, and is merely exemplary. In some embodiments, changes and deviations from the numerical nomenclature used previously may be made for brevity and clarity. That is, a feature identified as a "first" element may be referred to hereinafter 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 apparent to the skilled person.

Diseases and/or conditions that affect and/or are affected by the cardiovascular system are prevalent throughout the world. For example, certain forms of arteriovenous malformations (AVMs) may be nourished by the normal blood flow of the vascular system. Without being bound by theory, it is believed that it is possible to at least partially treat arterial venous malformations and/or other diseases or conditions by starving 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, shutting off blood flow prior to organ resection, or preventing embolic microbeads from flowing back into the branch vessels in the liver. Disclosed herein are medical devices that may be used within a portion of the cardiovascular system to treat and/or repair some arterial venous malformations and/or other diseases or conditions. The apparatus disclosed herein may also provide a number of additional desirable features and advantages, as described in more detail below.

Fig. 1 and 2 illustrate aspects of an exemplary medical device system 100. Medical device system 100 may include an elongate shaft 110 having a lumen 112 (e.g., fig. 2), the lumen 112 extending from a proximal end 114 of the elongate shaft 110 to a distal end 116 of the elongate shaft 110. In some embodiments, elongate shaft 110 may be a catheter, hypotube, or other similar tubular structure. In some embodiments, at least a portion of elongate shaft 110 may include micromachining, multiple cuts or weakened areas, some removal of matter, etc., to provide flexibility along the length of elongate shaft 110 for passage through tortuous vessels. Some suitable but non-limiting materials for elongate shaft 110 are described below, such as metallic materials, polymeric materials, composite materials, and the like.

The medical device system 100 can include a release wire 120 (e.g., fig. 2) slidably disposed within the lumen 112 of the elongate shaft 110. The medical device 130 may be disposed near the distal end 116 of the elongate shaft 110. The release wire 120 is axially slidable between an interlocked position and a released position. The medical device 130 may be configured to expand from a delivery configuration to a deployed configuration. The medical device 130 is illustrated herein as a vaso-occlusive device for simplicity, but other suitable medical devices that are transported, delivered, used, released, etc. in a similar manner are also contemplated, 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 release wire 120 may be alternatively and/or interchangeably referred to as a pull wire, an actuation wire, and/or a locking wire. The release wire 120 may be generally a solid wire or shaft, but may also be tubular in some embodiments. Some suitable but non-limiting materials for the release wire 120 are described below, such as metallic materials, polymeric materials, composite materials, and the like.

In some embodiments, the medical device system 100 may include a microcatheter 190 sized and configured to deliver the medical device 130 to the treatment site in a delivery configuration. The elongate shaft 110 and the medical device 130 may be slidably disposed within a lumen 192 (e.g., fig. 2) of the microcatheter 190. In some embodiments, the microcatheter 190 may facilitate the transdermal delivery of the medical device 130 to the treatment site. For reference, in the figures (e.g., fig. 1-2 and 5-7), the medical device 130 may be shown in a deployed configuration or at least a partially deployed configuration. One skilled in the art will recognize that when the medical device 130 is positioned within the lumen 192 of the microcatheter 190, the medical device 130 may be radially constrained into a delivery configuration (e.g., fig. 8-9). Some suitable but non-limiting materials for the microcatheter 190 are described below, such as metallic materials, polymeric materials, composite materials, and the like.

As shown in fig. 1 and 2, the medical device system 100 can include a securing member 140 fixedly attached to the proximal end of the elongate shaft 110 and/or extending proximally from the proximal end of the elongate shaft 110, and fixedly attached to the proximal end of the release wire 120. Fixation member 140 may include a proximal portion 142, a distal portion 144, and an attachment aperture 146, the attachment aperture 146 extending transversely and/or radially from an outer surface of the proximal portion 142 of fixation member 140 into the proximal portion 142 of fixation member 140.

In some embodiments, proximal portion 142 of fixation member 140 may be fixedly attached to distal portion 144 of fixation member 140. In some embodiments, the proximal portion 142 of the fixation member 140 may be integrally formed with the distal portion 144 of the fixation member 140 as a single structure. The proximal portion 142 of the fixation member 140 may take one or more of several different forms, including but not limited to a generally solid member, a tubular member, or a combination thereof. For example, the proximal portion 142 of the fixation member 140 may include an axial lumen extending along a central longitudinal axis of the medical device system 100, the elongate shaft 110, the release wire 120, and/or the fixation member 140, the axial lumen configured to receive a proximal end of the release wire 120. In some embodiments, the attachment hole 146 extending transversely and/or radially from the outer surface of the proximal portion 142 of the fixation member 140 to the proximal portion 142 of the fixation member 140 may intersect an axial lumen extending along the central longitudinal axis of the medical device system 100, the elongate shaft 110, the release wire 120, and/or the fixation member 140. Attachment holes 146 extending transversely and/or radially from the outer surface of the proximal portion 142 of the fixation member 140 to the proximal portion 142 of the fixation member 140 may be used to fixedly attach the proximal end of the release wire 120 to the proximal portion 142 of the fixation member 140, for example, using an adhesive, bonding agent, welding, or other attachment means.

In some embodiments, as shown in fig. 3 and 4, the proximal portion 142 of the fixation member 140 can be configured to translate proximally away from the proximal end 114 of the elongate shaft 110 upon application of a proximally-directed force to the proximal portion 142 of the fixation member 140 while maintaining the elongate shaft 110 in a fixed position. Further, in some embodiments, proximal portion 142 of fixation member 140 remains connected to proximal end 114 of elongate shaft 110, e.g., via distal portion 144 of fixation member 140, after proximal translation of proximal portion 142 of fixation member 140 away from the proximal end of elongate shaft 110.

A distal portion of fixation member 140 may be fixedly attached to proximal end 114 of elongate shaft 110. In some embodiments, the distal portion 144 of the fixation member 140 may be a coil spring or a helical member. In at least some embodiments, an outer surface of distal portion 144 of fixation member 140 can be fixedly attached to an inner surface of elongate shaft 110 (e.g., the surface defining lumen 112). In some embodiments, an inner surface of distal portion 144 of fixation member 140 may be fixedly attached to an outer surface of elongate shaft 110. In some embodiments, the distal end of distal portion 144 of fixation member 140 may be embedded within proximal end 114 of elongate shaft 110. In some embodiments, distal portion 144 may be integrally formed with elongate shaft 110 and/or integrally formed from elongate shaft 110. For example, in some embodiments, distal portion 144 may be cut through a portion of fixation member 140 and/or elongate shaft 110 (e.g., as a helical member or coil spring).

In some embodiments, the proximal portion 142 of the fixation member 140 may be visually distinct from the distal portion 144 of the fixation member 140 and/or the proximal end 114 of the elongate shaft 110. For example, the proximal portion 142 of the fixation member 140 may have and/or include a different color than the fixation member 140 and/or the distal portion 144 of the elongate shaft 110, a different external marking scheme than the fixation member 140 and/or the distal portion 144 of the elongate shaft 110, a different external texture or surface treatment than the fixation member 140 and/or the distal portion 144 of the elongate shaft 110, and/or other and/or additional means for visually distinguishing the proximal portion 142 of the fixation member 140 from the distal portion 144 of the fixation member 140 and/or the proximal end 114 of the elongate shaft 110. Some suitable but non-limiting materials for fixation member 140, proximal portion 142, and/or distal portion 144 are described below, such as metallic materials, polymeric materials, composite materials, and the like.

The walls of the distal portion 144 of the fixation member 140 (and/or the coil spring or helical member) may define a lumen, such as shown in fig. 3 and 4, wherein the release wire 120 is slidably disposed within the lumen of the distal portion 144 of the fixation member 140 (and/or the coil spring or helical member). The lumen of distal portion 144 of fixation member 140 (and/or a coil spring or helical member) may be coaxial and/or fluidly connected with lumen 112 of elongate shaft 110. Axial translation of the proximal portion 142 of the fixation member 140 away from and/or proximally relative to the proximal end 114 of the elongate shaft 110 can elongate the distal portion 144 of the fixation member 140 (and/or the coil spring or helical member) and translate the release wire 120 relative to the elongate shaft 110 from the interlocked position to the released position to release the medical device 130 from the distal end 116 of the elongate shaft 110, as will be explained in greater detail herein.

Fig. 5 and 6 generally illustrate release of the medical device 130 from the elongate shaft 110, such as at a treatment site. In use, the microcatheter 190 of the medical device system 100 can be inserted into the anatomy of a patient and the distal end of the microcatheter 190 can be guided and/or advanced to a position adjacent the treatment site. A medical device 130 disposed at the distal end 116 and/or near the distal end 116 of the elongate shaft 110 may be inserted into a proximal end of a lumen 192 (e.g., fig. 2) disposed within the microcatheter 190 and advanced through and/or with the microcatheter 190 to a treatment site. In some embodiments, the medical device 130 may be disposed within the lumen 192 of the microcatheter 190, near the distal end of the microcatheter 190. In some embodiments, the medical device 130 may be disposed within a lumen 192 near the distal end of the microcatheter 190 prior to use and/or prior to insertion of the microcatheter 190 into the anatomy of a patient (see, e.g., fig. 8). Deployment and/or release of the medical device 130 may be selectively performed depending on the type of medical device and/or the desired treatment procedure or method. When the medical device 130 is ready to be deployed, as seen in fig. 5, the elongate shaft 110 can be advanced and/or translated distally relative to the microcatheter 190 until the medical device 130 is exposed and/or distal of the microcatheter 190. Alternatively, the microcatheter 190 may be withdrawn relative to the elongate shaft 110 until the medical device 130 is exposed and/or distal of the microcatheter 190.

A release mechanism 170 may releasably attach the medical device 130 to the distal end 116 of the elongate shaft 110. In some embodiments, elongate shaft 110 may include a first portion 172 of release mechanism 170 fixedly attached to distal end 116 of elongate shaft 110, and medical device 130 may include a second portion 174 of release mechanism 170 fixedly attached to the proximal end of medical device 130. As shown in fig. 5, the distal end of the release wire 120 may 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 interlocked position. The release wire 120 interlocks the first portion 172 of the release mechanism 170 with the second portion 174 of the release mechanism 170 when the proximal portion 142 of the fixation member 140 is biased distally toward and/or in the interlocked position by the distal portion 144 of the fixation member 140 (and/or a coil spring or helical member). For example, when the proximal portion 142 of the fixation member 140 is translated proximally away from the proximal end 114 of the elongate shaft 110 (e.g., from an initial axial position B1 away from and/or relative to a reference position a-corresponding to the proximal end 114 of the elongate shaft 110 toward the predetermined axial position B2 and/or the release axial position B3), as shown in fig. 6, the release wire 120 is translated in a proximal direction relative to the elongate shaft 110 toward the release position to release the second portion 174 of the release mechanism 170 and/or the medical device 130 from the first portion 172 of the release mechanism 170 and/or the elongate shaft 110, as seen in more detail in fig. 7. In at least some embodiments, the release wire 120 can be slidably disposed within the distal portion 144 of the fixation member 140 (and/or a coil spring or helical member), the lumen 112 extending through the elongate shaft 110, a first axial lumen extending through the first portion 172 of the release mechanism 170, and a second axial lumen extending through the second portion 174 of the release mechanism 170. When the medical device 130 is releasably attached to the distal end 116 of the elongate shaft 110, the first axial lumen of the first portion 172 and the second axial lumen of the second portion 174 may be substantially coaxial with the central longitudinal axis and/or the release line 120. Some suitable but non-limiting materials for release mechanism 170, first portion 172, and second portion 174 are described below, such as metallic materials, polymeric materials, composite materials, and the like.

Referring to fig. 5 and 6, when the medical device 130 is disposed distal of the microcatheter 190, the elongate shaft 110 can have a sufficient length such that the proximal end 114 of the elongate shaft 110 and/or the fixation member 140 remain proximal (e.g., extend proximally) of the microcatheter 190. In use, the elongate shaft 110 can have a length sufficient to reach from a treatment site to a location outside of a patient where the medical device system 100 can be operated by an operator (e.g., a clinician, physician, user, etc.). After inserting the medical device system 100 to the treatment site, an operator of the medical apparatus system 100 may place a first hand on the proximal end 114 of the elongate shaft 110 and a second hand on the proximal portion 142 of the securing member 140 in order to operate the proximal portion 142 of the securing member 140 and/or the release wire 120 to release the medical apparatus 130. When the medical device 130 is disposed distal of the microcatheter 190, the distal portion 144 of the fixation member 140 (and/or the coil spring or helical member) may be disposed proximal of the microcatheter 190.

In at least some embodiments, the fixation member 140 can resist axial translation of the release wire 120 relative to the elongate shaft 110 and/or the medical device 130 (e.g., from an interlocked position to a released position). Distal portion 144 of fixation member 140 (and/or a coil spring or helical member) may be configured to bias proximal portion 142 of fixation member 140 distally toward proximal end 114 of elongate shaft 110 and/or an initial axial position B, as will be further described herein (e.g., see fig. 5-6). For example, distal portion 144 of fixation member 140 (and/or a coil spring or helical member) may be configured to be under tension between proximal portion 142 of fixation member 140 and proximal end 114 of elongate shaft 110, thereby pulling proximal portion 142 of fixation member 140 and proximal end 114 of elongate shaft 110 toward one another and resisting proximal translation of the proximal portion of fixation member 140 away from proximal end 114 of elongate shaft 110. When the proximal portion 142 of the securing member 140 is disposed in the initial axial position B1, the release wire 120 may be considered to be in the interlocked position.

In at least some embodiments, distal portion 144 of fixation member 140 (and/or a helical spring or member) can be elastically deformed during proximal translation of proximal portion 142 of fixation member 140 relative to elongate shaft 110 to a predetermined axial position B2, as described herein (e.g., fig. 5-6). Upon release after proximal portion 142 of fixation member 140 has translated proximally relative to elongate shaft 110 to a predetermined axial position B2, distal portion 144 of fixation member 140 (and/or a helical spring or coil member) may translate proximal portion 142 of fixation member 140 distally toward proximal end 114 of elongate shaft 110 and/or an initial axial position B1. Thus, at substantially any axial position of the proximal portion 142 of the fixation member 140 between the initial axial position B1 and the predetermined axial position B2, the release wire 120 interlocks the first portion 172 of the release mechanism 170 with the second portion 174 of the release mechanism 170, and thus may be considered to be in an interlocked position, and the medical device 130 is still attached to the elongate shaft 110. Further, at substantially any axial position of the proximal end portion 142 of the fixation member 140 between the initial axial position B1 and the predetermined axial position B2, the distal portion 144 of the fixation member 140 is configured to resiliently urge the proximal portion 142 of the fixation member 140 toward the initial axial position B1 and/or return the proximal portion 142 of the fixation member 140 toward the initial axial position B1. In an axial position between the initial axial position B1 and the predetermined axial position B2, the release of the medical device 130 can be considered fully reversible, and the release wire 120 can be pushed back distally by the first portion 172 of the release mechanism 170 and the second portion 174 of the release mechanism 170 to fully reengage the medical device 130 onto the elongate shaft 110, e.g., to reposition the medical device 130.

In at least some embodiments, the distal portion 144 of the fixation member 140 (and/or the coil spring or helical member) can be plastically deformed after the proximal portion 142 of the fixation member 140 has passed the predetermined axial position B2 to the release axial position B3 relative to the elongate shaft 110, as discussed herein (e.g., fig. 5-6). In some embodiments, the release axial position B3 may correspond to a maximum or upper limit of the stretch and/or elongation of the distal portion 144 of the fixation member 140 (and/or a coil spring or helical member). In some embodiments, the distal portion 144 (and/or the coil spring or helical member) of the fixation member 140 may stretch and/or elongate past the release axial position B3. When the proximal portion 142 of the fixation member 140 is released after the proximal portion 142 of the fixation member 140 has translated proximally relative to the elongate shaft 110 past the predetermined axial position B2, the axial position of the proximal portion 142 of the fixation member 140 remains substantially fixed relative to the proximal end 114 of the elongate shaft 110 and/or the initial axial position B1.

At any axial position between the predetermined axial position B2 and the release axial position B3, the distal portion 144 of the fixation member 140 is plastically deformed, and the release of the medical device 130 may be considered irreversible because complete re-engagement of the release wire 120 with the first portion 172 of the release mechanism 170 and the second portion 174 of the release mechanism 170 is no longer possible. However, at any axial position between the predetermined axial position B2 and the release axial position B3, the release wire 120 remains partially engaged with and/or extends at least partially through the first portion 172 of the release mechanism 170 and the second portion 174 of the release mechanism 170, and the medical device 130 remains attached to the elongate shaft 110, and the medical device 130 can be removed from the patient's anatomy by withdrawing the medical device 130 proximally into the lumen 192 of the microcatheter 190. In itself, full release is not strictly necessary, but the function of repositioning the medical device 130 may be limited or terminated at any axial position between the predetermined axial position B2 and the release axial position B3.

In some embodiments, the release wire 120 includes at least one indicator configured to visually communicate the deformed state of the distal portion 144 (and/or the coil spring or the helical member) of the fixation member 140. For example, the at least one indicator may be configured to visually communicate to a user whether the distal portion 144 of the fixation member 140 (and/or the coil spring or the helical member) is undergoing elastic deformation or plastic deformation, and/or whether the distal portion 144 of the fixation member 140 (and/or the coil spring or the helical member) is within an elastically or plastically deformed region. In some embodiments, the at least one indicator may include at least one colored portion of the release line 120, where each colored portion corresponds to one and/or different deformation states.

For example, in some embodiments, the at least one indicator may comprise a first indicator configured to visually communicate to a user that the distal portion 144 of the fixation member 140 (and/or the helical spring or coil member) is elastically deforming and/or is within an elastic deformation region (e.g., at an axial position between the initial axial position B1 and the predetermined axial position B2). In some embodiments, the at least one indicator may include a second indicator configured to visually communicate to the user that the distal portion 144 of the fixation member 140 (and/or the coil spring or the helical member) is being plastically deformed and/or is within a region of plastic deformation (e.g., at any axial position past the predetermined axial position B2, and/or at any axial position between the predetermined axial position B2 and the release axial position B3). In some embodiments, the first indicator may be a first colored region of the release wire 120 visible through and/or within the distal portion 144 (and/or the coil spring or the helical member) of the fixation member 140. In some embodiments, the second indicator may be a second colored region of the release wire 120 visible through and/or within the distal portion 144 of the fixation member 140 (and/or the coil spring or helical member), wherein the second colored region of the release wire 120 is a different color than the first colored region of the release wire 120.

In some embodiments, the at least one indicator, the first colored region, the second indicator, and/or the second colored region may be formed and/or presented as a reflowed polymer on the release wire 120 or a non-ferrous material affixed (e.g., crimped, welded, adhered/glued, etc.) to the release wire 120. Other ways of forming and/or presenting at least one indicator, first colored region, second indicator, and/or second colored region are also contemplated, including but not limited to anodization, electroplating, laser marking, chemical modification, and the like.

At any axial position after the proximal portion 142 of the fixation member 140 passes proximally past the release axial position B3, the release wire 120 releases the first portion 172 of the release mechanism 170 from the second portion 174 of the release mechanism 170, and thus may be considered to be in the release position, and the medical device 130 is released from the elongate shaft 110. Further proximal axial translation of the proximal portion 142 of the fixation member 140 relative to the elongate shaft 110 past the release axial position B3 may provide additional clearance and/or less precision to the practitioner while safely releasing the medical device 130.

In some embodiments, as shown in fig. 1-6, the proximal portion 142 of the fixation member 140 may assume a generally linear configuration when unconstrained. Additionally, in some embodiments, when unconstrained, the proximal portion 142 of the fixation member 140 can assume a non-linear configuration (e.g., curvilinear, curved, jagged, wavy, serpentine, etc.), one example of which can be seen in fig. 8. The medical device system 100 may include an introducer 180 configured to load the medical device 130 into a microcatheter 190. Introducer 180 may be a tubular member having a lumen extending from a proximal end to a distal end. While described in connection with the non-linear configuration of the proximal portion 142 of the fixation member 140 in fig. 8-9, those skilled in the art will recognize that the introducer 180 may be useful in all configurations of the proximal portion 142 of the fixation member 140, including the linear configuration shown in fig. 1-6. The introducer 180 may hold the medical device 130 in a reduced diameter and/or delivery configuration for loading into the microcatheter 190. After loading the medical device 130 into the microcatheter 190, the introducer 180 may be withdrawn over and proximally relative to the elongate shaft 110 and fixation member 140 and removed from the medical device system 100.

In at least some embodiments, having the proximal portion 142 of the fixation member 140 assuming a non-linear configuration when unconstrained, retraction of the introducer 180 over the fixation member 140 and relative to the fixation member 140, and in particular over the proximal portion 142 of the fixation member 140 and proximally relative to the proximal portion 142 of the fixation member 140, may advance, constrain, and/or position the proximal portion 142 of the fixation member 140 in a substantially linear configuration while the proximal portion 142 of the fixation member 140 is disposed within the lumen of the introducer 180, as shown in fig. 9. Further proximal withdrawal and/or removal of the introducer 180 from the proximal portion 142 of the fixation member 140 may remove the constraint created by the introducer 180 and thereafter allow the proximal portion 142 of the fixation member 140 to return to and/or assume a non-linear configuration. The non-linear configuration of the proximal portion 142 of the fixation member 140 may facilitate and/or facilitate the identification, grasping and/or manipulation of the proximal portion 142 of the fixation member 140 by a practitioner.

In another configuration, the introducer 180 may be configured to assume a non-linear configuration of the proximal portion 142 of the fixation member 140 when the introducer 180 is withdrawn proximally from over the proximal portion 142 of the fixation member 140 and/or relative to the proximal portion 142 of the fixation member 140. For example, the introducer 180 may be made of a flexible material that allows the introducer 180 to flex, deflect and/or bend to conform to the non-linear configuration of the proximal portion 142 of the fixation member 140 as the introducer 180 translates over the proximal portion 142 of the fixation member 140. Other configurations are also contemplated.

In use, a method of delivering the medical device 130 to a treatment site (e.g., vein, artery, etc.) may include inserting the microcatheter 190 into a patient's anatomy and guiding a distal end of the microcatheter 190 to a location adjacent to the treatment site. The method may include inserting a medical device 130 disposed at the distal end 116 of the elongate shaft 110 and/or near the distal end 116 of the elongate shaft 110 into the proximal end of a lumen 192 disposed within a microcatheter 190. In some embodiments, the medical device 130 may be inserted into the lumen 192 of the microcatheter 190 after the microcatheter 190 is inserted into the anatomy of the patient. 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 elongate shaft 110 by a pull wire (e.g., release wire 120, etc.) extending through the lumen 112 within the elongate shaft 110. The fixation member 140 can extend proximally from the elongate shaft 110, and the fixation member 140 can be fixedly attached to the elongate shaft 110 and a pull wire (e.g., release wire 120, etc.), as described herein. 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 lumen 192 of the microcatheter 190 before the microcatheter 190 is inserted into the patient's anatomy.

As discussed herein, the proximal portion 142 of the fixation member 140 can be fixedly attached to the proximal end of a pull wire (e.g., release wire 120, etc.), and the distal portion 144 of the fixation member 140 can be fixedly attached to the proximal end 114 of the elongate shaft 110. A first portion 172 of release mechanism 170 may be attached to distal end 116 of elongate shaft 110, and a second portion 174 of release mechanism 170 may be fixedly attached to the proximal end of medical device 130. The pull wire (e.g., release wire 120, etc.) may be slidably disposed within the lumen of the distal portion 144 of the fixation member 140, within the lumen 112 of the elongate shaft 110, within a first axial lumen of the first portion 172 of the release mechanism 170, and within a second axial lumen of the second portion 174 of the release mechanism 170.

The method may include translating the proximal portion 142 of the fixation member 140 proximally away from the proximal end 114 of the elongate shaft 110 while the elongate shaft 110 is held in a fixed position relative to the treatment site to translate the pull wire (e.g., the release wire 120, etc.) relative to the elongate shaft 110 and/or the release mechanism 170 to move the pull wire (e.g., the release wire 120, etc.) from the interlocked position to the released position, thereby releasing the medical device 130 from the elongate shaft 110. As described herein, proximal portion 142 of fixation member 140 remains coupled to proximal end 114 of elongate shaft 110 after proximal translation away from proximal end 114 of elongate shaft 110, such as through distal portion 144 of fixation member 140.

The method may further include proximally withdrawing the elongate shaft 110 and/or the microcatheter 190 from the treatment site. For example, in some embodiments, the elongate shaft 110 may be proximally withdrawn and removed through the lumen 192 of the microcatheter 190, and then the microcatheter 190 may be withdrawn and/or removed from the patient's anatomy. In some embodiments, the elongate shaft 110 can be withdrawn proximally far enough that the distal end 116 of the elongate shaft 110 and/or the first portion 172 of the release member 170 are positioned within the distal end of the microcatheter 190 and/or within the lumen 192. The elongate shaft 110 and microcatheter 190 can then be withdrawn together from the patient's anatomy.

In some embodiments, the elongate shaft 110 may be removed through the lumen 192 of the microcatheter 190, and the microcatheter 190 may be left and/or retained within the anatomy of the patient. If desired, a second elongate shaft and 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 deployment. Additional iterations of the apparatus and method steps described herein can be used as needed or desired for a particular procedure.

Materials that may be used for various elements of the medical device system 100, elongate shaft 110, release wire 120, medical device 130, fixation member 140, release mechanism 170, introducer 180, and/or microcatheter 190, etc. (and/or other systems disclosed herein) and the various elements disclosed herein may include those typically associated with medical devices. For simplicity, the following discussion refers to the medical device system 100, the elongate shaft 110, the release wire 120, the medical device 130, the fixation member 140, the release mechanism 170, the introducer 180, and/or the microcatheter 190, among others. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other elements, members, assemblies, or devices disclosed herein, such as, but not limited to, medical device system 100, elongate shaft 110, release wire 120, medical device 130, fixation member 140, release mechanism 170, introducer 180, microcatheter 190, and/or the like, and/or elements or assemblies thereof.

In some embodiments, the medical device system 100, the elongate shaft 110, the release wire 120, the medical device 130, the fixation member 140, the release mechanism 170, the introducer 180, and/or the microcatheter 190, etc., and/or components thereof (e.g., without limitation, the proximal portion 142, the distal portion 144, the first portion 172, the second portion 174, etc.), may be made of a metal, a metal alloy, a polymer (some examples of which are disclosed below), a metal-polymer composite, a ceramic, combinations thereof, etc., or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels, such as 444V, 444L, and 314LV stainless steels; 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 asUNS: n06022 such asUNS: n10276 such as

OthersAlloys, etc.), nickel-copper alloys (e.g., UNS: n04400, e.g.

Etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: r44035, such asEtc.), nickel-molybdenum alloys (such as UNS: n10665, e.g.) 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, and the like; cobalt chromium complexGold; cobalt chromium molybdenum alloys (e.g., UNS: R44003, such asEtc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; and the like; or any other suitable material.

As alluded to herein, in the commercially available nickel-titanium alloys or nitinol series, there is a class referred to as "linear elastic" or "non-superelastic" although it may be chemically similar to conventional shape memory and superelastic varieties and may exhibit unique and useful mechanical properties. Linear elastic and/or non-superelastic nitinol differs from superelastic nitinol in that linear elastic and/or non-superelastic nitinol does not exhibit a substantial "superelastic plateau" or "marker zone" in its stress/strain curve. Rather, in linear elastic and/or non-superelastic nitinol, as recoverable strain increases, stress continues to increase in a substantially linear or somewhat but not necessarily fully linear relationship until plastic deformation begins or at least in the relationship, the linear relationship is more linear than the superelastic plateau and/or marker region seen with superelastic nitinol. Thus, for the purposes of the present invention, linear elastic and/or non-superelastic nitinol may also be referred to as "substantially" linear elastic and/or non-superelastic nitinol.

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 undergo up to about 2-5% strain while remaining substantially elastic (e.g., prior to plastic deformation), whereas superelastic nitinol may undergo up to about 8% strain prior to plastic deformation. Both of these materials can be distinguished from other linear elastic materials, such as stainless steel (which can also be distinguished by its composition), which can only accept approximately 0.2% to 0.44% strain prior to plastic deformation.

In some embodiments, a linear elastic and/or non-superelastic nickel-titanium alloy is an alloy that does not exhibit any martensite/austenite phase transitions detectable by Differential Scanning Calorimetry (DSC) and Dynamic Metal Thermal Analysis (DMTA) analysis over a wide temperature range. For example, in some embodiments, the martensite/austenite phase transformation in a linear elastic and/or non-superelastic nickel-titanium alloy may not be detectable by DSC and DMTA analysis in the range of about-60 degrees celsius (° c) to about 120 ℃. Thus, the mechanical bending properties of such materials are generally inert to temperature effects over such a very wide temperature range. In some embodiments, the mechanical bending properties at ambient or room temperature of the linear elastic and/or non-superelastic nitinol alloys are substantially the same as the mechanical properties at body temperature, e.g., because they do not exhibit superelastic plateau and/or marker regions. In other words, the linear elastic and/or non-superelastic nickel-titanium alloy retains its linear elastic and/or non-superelastic properties and/or performance over a wide temperature range.

In some embodiments, the linear elastic and/or non-superelastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being substantially titanium. In some embodiments, the nickel content of the composition is about 54% to about 57% nickel by weight. An example of a suitable nickel-titanium alloy is FHP-NT alloy available from the ancient river science Co., Shenkanchuan, Japan (Furukawa Techno Material Co.). Other suitable materials may include ULTANIUM^TM(available for purchase from Neo-Metrics) and GUM METAL^TM(available from Toyota). In some other embodiments, superelastic alloys, such as superelastic nitinol, may be used to achieve the desired properties.

In at least some embodiments, portions or all of the medical device system 100, elongate shaft 110, release wire 120, medical device 130, fixation member 140, release mechanism 170, introducer 180, and/or microcatheter 190, etc., and/or combinations thereof, may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials that are capable of producing a relatively bright image on a fluoroscopic screen or other imaging technique during a medical procedure. The relatively bright image assists the user in determining the position of the medical device system 100, the elongate shaft 110, the release wire 120, the medical device 130, the fixation member 140, the release mechanism 170, the introducer 180, and/or the microcatheter 190, etc. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. In addition, other radiopaque marker bands and/or coils may also be incorporated into the design of the medical device system 100, elongate shaft 110, release wire 120, medical device 130, fixation member 140, release mechanism 170, introducer 180, and/or microcatheter 190, etc., to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted to the medical device system 100, the elongate shaft 110, the release wire 120, the medical device 130, the fixation member 140, the release mechanism 170, the introducer 180, and/or the microcatheter 190, etc., and/or components or portions thereof, may be made of a material that does not substantially distort the image and create a large number of artifacts (e.g., gaps in the image). For example, some ferromagnetic materials may not be suitable because they may create artifacts in the MRI images. The medical device system 100, elongate shaft 110, release wire 120, medical device 130, fixation member 140, release mechanism 170, introducer 180, and/or microcatheter 190, etc., or portions 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, e.g.

Etc.), nitinol, etc., among others.

In some embodiments, the medical device system 100, elongate shaft 110, release wire 120, medical device 130, fixation member 140, release mechanism 170, introducer 180, and/or microcatheter 190, etc., and/or portions thereof, may be made of a polymer or other suitable materialOr comprise a polymer or other suitable material. Some examples of suitable polymers may include Polytetrafluoroethylene (PTFE), Ethylene Tetrafluoroethylene (ETFE), Fluorinated Ethylene Propylene (FEP), polyoxymethylene (POM, e.g., available from DuPont

) Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from Disemann Engineering Plastics (DSM Engineering Plastics))) Ether or ester based copolymers (e.g., butylene/poly (alkylene ether) phthalate and/or other polyester elastomers such as those available from DuPont

) Polyamides (e.g. available from Bayer (Bayer))

Or available from Elf Atochem

) Elastomeric polyamides, polyamide/ether blocks, polyether block amides (PEBA, for example in

Trade names of the following), ethylene vinyl acetate copolymer (EVA), silicone, Polyethylene (PE), Marek's high density polyethylene, Marek's low density polyethylene, linear low density polyethylene (e.g., polyethylene glycol terephthalate), polyethylene (PE) Polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), Polyetheretherketone (PEEK), Polyimides (PI), Polyetherimides (PEI)) Polyphenylene Sulfide (PPS), polyphenylene oxide (PPO), polyterephthalamide (e.g.,

) Polysulfones, nylons 12 (e.g. available from EMS America Grilon)

) Perfluoropropylvinylether (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly (styrene-b-isobutylene-b-styrene) (e.g., SIBS and/or SIBS 50A), polycarbonate, ionomer, biocompatible polymer, other suitable material or mixtures thereof, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments, the jacket may be mixed with a Liquid Crystal Polymer (LCP). For example, the mixture may contain up to about 6% LCP.

In some embodiments, the medical device systems 100, elongate shafts 110, release wires 120, medical devices 130, fixation members 140, release mechanisms 170, introducers 180, microcatheters 190, and/or the like disclosed herein may include a fabric material on or within a structure. The textile material may be composed of a biocompatible material, such as a polymeric material or a biomaterial, adapted to promote tissue ingrowth. In some embodiments, the fabric material may comprise 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.

In some embodiments, the medical device system 100, the elongate shaft 110, the release wire 120, the medical device 130, the fixation member 140, the release mechanism 170, the introducer 180, and/or the microcatheter 190, etc., may comprise and/or be made of a textile material. Some examples of suitable textile materials may include synthetic yarns, which may be flat, shaped, twisted, textured, pre-shrunk, or non-shrunk. Synthetic biocompatible yarns suitable for use in the present invention include, but are not limited to, polyesters including polyethylene terephthalate (PET) polyester, polypropylene, polyethylene, polyurethane, polyolefin, polyvinyls, polymethylacetates, polyamides, naphthalene dicarboxyl 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 metal yarns include those made of or comprising stainless steel, platinum, gold, titanium, tantalum or nickel cobalt chromium based alloys. The yarn may further comprise carbon, glass or ceramic fibers. Desirably, the yarns are made of thermoplastic materials including, but not limited to, polyester, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, and the like. The yarns may be of the multifilament, monofilament or staple type. The type and denier of the selected yarn are selected in a manner to form a biocompatible and implantable prosthesis, and more particularly, a vascular structure having desired properties.

In some embodiments, the medical device system 100, elongate shaft 110, release wire 120, medical device 130, fixation member 140, release mechanism 170, introducer 180, and/or microcatheter 190, etc., may include and/or be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents may include antithrombotic agents (e.g., heparin derivatives, urokinase and PPack (dextro phenylalanine proline arginine chloromethyl ketone)); antiproliferative agents (e.g., enoxaparin, angiopeptins, monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory agents (e.g., dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine); antineoplastic/antiproliferative/antimitotic agents (e.g., paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); anticoagulants (e.g., D-phenylpropanolamino-arginine chloromethyl ketone, RGD peptide-containing compounds, heparin, anticoagulant compounds, platelet receptor antagonists, anticoagulant antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (e.g., growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, and translational promoters); vascular cell growth inhibitors (e.g., growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies to growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins); a cholesterol lowering agent; a vasodilator; and agents that interfere with endogenous vasoactive mechanisms.

It should be understood that the present invention is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. This may include using any feature of one embodiment in other embodiments, to the extent appropriate. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.