Medical device release system

Abstract

The medical device system includes an elongate sheath defining a lumen extending within the elongate sheath. A coupler mechanism is slidably disposed within the lumen and includes a proximal coupler and a distal coupler. An elongate member is secured to and extends proximally from the proximal coupler. An implantable medical device (IMD) is secured to and extends distally from the distal coupler. The distal coupler remains secured to the proximal coupler while the coupler mechanism is within said lumen, and when the coupler mechanism is outside of the lumen, the distal coupler is released from the proximal coupler, thereby releasing the IMD.

Description

Technical Field

[0001] The present disclosure relates to medical devices and methods for manufacturing and / or using medical devices. More specifically, the present disclosure relates to the configuration of a system for releasing a medical implant.

Background Art

[0002] A wide variety of medical devices are being developed for medical applications, such as surgical and / or endovascular applications. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and can be used according to any one of a variety of methods. There is a continuing need to provide alternative medical devices and alternative methods for manufacturing and / or using medical devices.

Summary of the Invention

[0003] The present disclosure relates to the configuration of a system for releasing a medical implant. One example can be found in a medical device system. The medical device system includes a long sheath defining a lumen extending within the long sheath. A coupler mechanism is slidably disposed within the lumen and includes a proximal coupler and a distal coupler. A long member is fixed to the proximal coupler and extends proximally from the proximal coupler. An implantable medical device (IMD) is fixed to the distal coupler and extends distally from the distal coupler. The distal coupler remains fixed to the proximal coupler while the coupler mechanism remains within the lumen, and when the coupler mechanism is outside the lumen, the distal coupler is released from the proximal coupler, thereby releasing the IMD.

[0004] Alternatively, or in addition, the coupler mechanism may be adapted to move outside the lumen by retracting the elongated sheath proximally while holding the elongated member in a stationary position.

[0005] Alternatively, or in addition, the coupler mechanism may be adapted to move outside the lumen by extending the elongated member distally while holding the elongated sheath proximally.

[0006] Alternatively, or in addition, the coupler mechanism may be adapted to allow relative radial movement between the distal coupler and the proximal coupler, while restricting relative axial movement between them, when not specifically constrained by the elongated sheath.

[0007] Alternatively, or in addition, the distal coupler may include a first support surface, and the proximal coupler may include a second support surface, the first support surface engaging with the second support surface to restrict relative axial movement between them.

[0008] Alternatively, or in addition, the coupler mechanism may be adapted such that distal movement of the elongated member is transmitted to the IMD via the coupler mechanism while the IMD remains fixed to the distal coupler.

[0009] Alternatively, or in addition, the coupler mechanism may be adapted such that the proximal movement of the elongated member is transmitted to the IMD via the coupler mechanism while the IMD remains fixed to the distal coupler.

[0010] Alternatively, or in addition, the IMD may include an embolic coil. Alternatively, or in addition, one of the distal coupler and the proximal coupler may include a projection, and the other of the distal coupler and the proximal coupler may include a recess, the recess being complementary to the projection such that the projection fits into the recess.

[0011] Alternatively, or in addition, the projection may be adapted to slide radially within the recess complementary to the projection. Alternatively, or in addition, the projection may include a trapezoidal projection.

[0012] Alternatively, or in addition, the projection may include a linear projection. Alternatively, or in addition, the projection may include a frustoconical projection. Alternatively, or in addition, the projection may include a bulbous projection.

[0013] Another example can be found in a system for delivering an embolization coil. This system includes an elongated sheath defining a lumen extending within the elongated sheath, an elongated member extending through the lumen, and a coupler mechanism slidably positioned within the lumen and releasably coupling an embolization coil to the elongated member. The coupler mechanism is adapted to prevent the embolization coil from separating from the elongated member while the coupler mechanism is radially constrained by the elongated sheath, and to allow the embolization coil to separate from the elongated member when the coupler mechanism is no longer radially constrained by the elongated sheath.

[0014] Alternatively, or in addition, the coupler mechanism may include a first coupler segment fixed to the elongated member and a second coupler segment fixed to the embolus coil.

[0015] Alternatively, or in addition, the first coupler segment may be adapted to engage with the second coupler segment and restrict relative axial movement between them when the coupler mechanism is radially constrained by the elongated sheath.

[0016] Alternatively, or in addition, the first coupler segment may be adapted to disengage from the second coupler segment when the coupler mechanism is not radially constrained by the elongated sheath, thereby freeing the embolus coil from the elongated member.

[0017] Alternatively, or in addition, the second coupler segment may remain fixed to the embolus coil when the embolus coil is released from the elongated member. Another example can be found in an embolization system. This embolization system includes an elongated sheath defining a lumen extending within the elongated sheath; a coupler mechanism slidably disposed within the lumen and including a proximal coupler and a distal coupler; an elongated member fixed to the proximal coupler and extending proximal to the proximal coupler; and an embolization coil fixed to the distal coupler and extending distal to the distal coupler. The distal coupler remains fixed to the proximal coupler while the coupler mechanism remains within the lumen, and is released from the proximal coupler when the coupler mechanism is outside the lumen, thereby releasing the embolization coil and the proximal coupler.

[0018] The above summary of some embodiments, aspects, and / or examples is not intended to describe every embodiment or all implementation of the present disclosure. The following drawings and detailed description illustrate these embodiments more specifically. [Brief explanation of the drawing]

[0019] This disclosure can be better understood by considering the following detailed description of various embodiments in relation to the attached drawings. [Figure 1] This is a schematic side view of an exemplary delivery device for delivering an implantable medical device (IMD), showing an IMD within the delivery device. [Figure 2] Figure 1 is a schematic side view of an exemplary delivery device showing IMD emitted from the delivery device. [Figure 3] A schematic side view of an exemplary delivery device showing an IMD removed from the delivery device of FIG. 1. [Figure 4A] A perspective view of an exemplary coupler mechanism that can be used to releasably secure an IMD to the delivery device of FIG. 1. [Figure 4B] A perspective view of an exemplary coupler mechanism of FIG. 4A with two coupler segments separated from each other. [Figure 4C] A perspective view of a first coupler segment forming part of the exemplary coupler mechanism of FIG. 4A. [Figure 4D] A perspective view of a second coupler segment forming part of the exemplary coupler mechanism of FIG. 4A. [Figure 5A] A side view of an exemplary coupler mechanism that can be used to releasably secure an IMD to the delivery device of FIG. 1. [Figure 5B] A side view of an exemplary coupler mechanism of FIG. 5A with two coupler segments separated from each other. [Figure 6A] A perspective view of an exemplary coupler mechanism that can be used to releasably secure an IMD to the delivery device of FIG. 1. [Figure 6B] A perspective view of an exemplary coupler mechanism of FIG. 6A with two coupler segments separated from each other. [Figure 7A] A perspective view of an exemplary coupler mechanism that can be used to releasably secure an IMD to the delivery device of FIG. 1. [Figure 7B] A perspective view of an exemplary coupler mechanism of FIG. 7A with two coupler segments separated from each other.

[0020] Aspects of the present disclosure can accept various modifications and alternative forms, and details thereof are shown in the drawings by way of example and are described in detail. However, it should be understood that the intention is not to limit aspects of the present disclosure to the specific embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternative forms that fall within the spirit and scope of the present disclosure. [Modes for carrying out the invention]

[0021] The following description should be read with reference to the drawings, which are not necessarily to scale, and similar reference numbers indicate similar elements in several drawings. The detailed description and drawings are intended to illustrate, but not to limit, the inventions described in the claims. Those skilled in the art will recognize that the various elements described and / or shown may be arranged in various combinations and configurations without departing from the scope of this disclosure. The detailed description and drawings illustrate exemplary embodiments of the inventions described in the claims.

[0022] The terms defined below shall apply unless otherwise given in the claims or elsewhere in this specification. All numerical values ​​in this specification, whether expressly indicated or not, are assumed to be modified by the term “approximately.” In the context of numerical values, “approximately” generally refers to a range of numbers that a person skilled in the art would consider equivalent to (e.g., having the same function or result as) the stated value. Often, the term “approximately” may include numbers rounded to the nearest significant figure. Other uses of the term “approximately” (e.g., in non-numerical contexts) are assumed to have their usual customary definitions, to be understood in the context of this specification and consistent with the context of this specification, unless otherwise specified.

[0023] Numerical ranges specified by endpoints include all numbers within that range, including the endpoint (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). While several appropriate dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, a person skilled in the art, driven by this disclosure, will understand that desired dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0024] Where used herein and in the appended claims, the singular forms “a,” “an,” and “the” include multiple references unless the context clearly indicates otherwise. Where used herein and in the appended claims, the term “or” is used generally to include “and / or” unless the context clearly indicates otherwise. For ease of understanding, note that certain features of this disclosure may be described in the singular, even if those features may be multiple or repeated within the disclosed embodiments. Each instance of a feature includes and / or may be encompassed by a singular disclosure unless it is expressly stated otherwise. For simplification and clarity, not all elements of the disclosed invention are necessarily shown in each figure or described in detail below. However, it will be understood that the following descriptions may apply equally to any and / or all of the more than one component unless it is expressly stated otherwise. Furthermore, for clarity, not all examples of some elements or features are shown in each figure.

[0025] Relative terms such as “proximal,” “distal,” “forward,” “backward,” and their variations may generally be considered in relation to the positioning, orientation, and / or movement of various elements of a device relative to the user / operator / manipulator; “proximal” and “backward” indicate or refer to being closer to or toward the user, while “distal” and “forward” indicate or refer to being further away from or away from the user. In some cases, the terms “proximal” and “distal” may be arbitrarily assigned to facilitate understanding of this disclosure, and in such cases, 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 lumen, a blood vessel, or within a device.

[0026] The term “range” may be understood to mean the maximum measured value of a given or specified dimension. For example, “outer range” may be understood to mean the maximum outer dimension, “radial range” may be understood to mean the maximum radial dimension, and “longitudinal range” may be understood to mean the maximum longitudinal dimension, and so on. Each example of “range” may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and this will be apparent to those skilled in the art from the context of the individual usage. In general, “range” may be considered the maximum possible dimension measured according to its intended use. In some cases, “range” may be measured perpendicularly in a plane and / or cross-section in general, but may also be measured differently, angularly, radially, circumferentially (e.g., along an arc), etc., though not limited to these, as will be apparent from the particular context.

[0027] It should be noted that references to “embodiments,” “some embodiments,” and “other embodiments” in this specification indicate that the embodiments described may include certain features, structures, or characteristics, but not all embodiments necessarily include those particular features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiments. Moreover, if certain features, structures, or characteristics are described in relation to an embodiment, it would be within the knowledge of those skilled in the art that they may result in those features, structures, or characteristics in relation to other embodiments, whether or not they are explicitly described, unless otherwise explicitly stated. In other words, the various individual elements described below are considered combinable or configurable with each other to form other additional embodiments or to complement and / or enhance the embodiments described, even if they are not explicitly shown in specific combinations, as will be understood by those skilled in the art.

[0028] For 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 features of the description and / or claims. It should be understood that numerical nomenclature is not intended to be limiting, but merely illustrative. In some embodiments, for brevity and clarity, modifications and deviations from previously used numerical nomenclature may be made. That is, a feature identified as the “First” element may later be referred to as the “Second” element, the “Third” element, and so on, or may be omitted entirely, and / or a different feature may be referred to as the “First” element. The meaning and / or names in each example will be obvious to those skilled in the art.

[0029] Various implantable medical devices (IMDs) can be delivered to a delivery site in the patient's body via an intravascular delivery route. Figures 1 to 3 provide exemplary techniques for delivering IMDs. In some cases, the IMD may be an embolization coil, but this disclosure is not limited to embolization coils, and any of various different IMDs may be delivered in the manner described herein. Figure 1 is a schematic diagram of a medical device system 10 including an elongated sheath 12 defining a lumen 14 extending through the elongated sheath 12. The elongated sheath 12 may be a single-layer polymer sheath, a double-layer polymer sheath, or a multi-layer polymer sheath. The elongated sheath 12 may include reinforcing structures such as braids or coils. In some cases, although not shown, the elongated sheath 12 may include one or more radiopaque markers that are visible under fluoroscopy, for example.

[0030] Several internal components are schematically shown by dashed lines. The coupler mechanism 16 is slidably positioned within the lumen 14. In some cases, as shown, the coupler mechanism 16 includes a proximal coupler 18 and a distal coupler 20. The proximal coupler 18 may be fixed to a longitudinal member 22, which may be operated, for example, at the proximal end (not shown) of the medical device system 10 to move the longitudinal member 22 and thus the coupler mechanism 16 axially within the lumen 14. In some cases, the proximal coupler 18 may be fixed to the longitudinal member 22 by laser welding, soldering, swaging, crimping, or bonding the proximal end of the proximal coupler 18 to the longitudinal member 22. The distal coupler 20 may be fixed to the IMD 24, which may remain fixed to the IMD 24 even after the IMD 24 has been deployed.

[0031] The proximal coupler 18 and distal coupler 20 may be formed from any suitable material. In some cases, the proximal coupler 18 and distal coupler 20 may be formed from platinum, iridium, stainless steel, or another biocompatible material. The proximal coupler 18 and distal coupler 20 may be manufactured using laser ablation to ablate the material used to produce the proximal coupler 18 and distal coupler 20. In some cases, microfabrication may be used to manufacture the proximal coupler 18 and distal coupler 20. In some cases, a combination of additive and subtractive manufacturing may be used when manufacturing the proximal coupler 18 and / or distal coupler 20. Three-dimensional (3D) printing is an example of an additive manufacturing process. Ablation is an example of a subtractive manufacturing process.

[0032] In some examples, the coupler mechanism 16 may be designed such that the proximal coupler 18 and the distal coupler 20 remain locked together until release of the IMD 24 is desired. For example, the proximal coupler 18 and the distal coupler 20 may be fitted to engage with each other to allow axial movement of the coupler mechanism 16 within the lumen 14, as long as the coupler mechanism 16 remains within the lumen 14. The proximal coupler 18 and the distal coupler 20 may be fitted to disengage from each other when the coupler mechanism 16 or at least a part of it moves to a position outside the lumen 14. In some cases, the proximal coupler 18 and the distal coupler 20 are fitted to remain engaged with each other when they are constrained from relative radial movement, including being radially constrained by the elongated sheath 12.

[0033] The coupler mechanism 16 may be adapted so that the axial movement of the elongated member 22 is transmitted to the IMD 24 via the coupler mechanism 16 while the coupler mechanism 16 remains within the lumen 14. For example, the IMD 24 may be moved distally by pushing the elongated member 22 distally relative to the elongated sheath 12. The IMD 24 may be moved proximal by pulling the elongated member 22 proximal to the elongated sheath 12. The distal end 26 of the elongated sheath 12 may be moved closer to the IMD 24 by pulling the elongated sheath 12 proximal while holding the elongated member 22 in a stationary position. The distal end 26 of the elongated sheath 12 may be moved further away from the IMD 24 by pushing the elongated sheath 12 distally while holding the elongated member 22 in a stationary position.

[0034] Figure 1 shows the coupler mechanism 16 and IMD 24 completely within the lumen 14. Figures 2 and 3 show the deployment of the IMD 24. In Figure 2, the elongated member 22 is advanced distally to the elongated sheath 12 (or the elongated sheath 12 is retracted proximal to the elongated member 22). As a result, the coupler mechanism 16 and IMD 24 are outside the lumen 14, while the elongated member 22 extends proximal within the lumen 14. At this point, the coupler mechanism 16 is no longer radially constrained by the elongated sheath 12. This means that the proximal coupler 18 and the distal coupler 20 can move freely radially relative to each other. For example, the proximal coupler 18 can move freely in a first radial direction indicated by arrow 28, and / or the distal coupler 20 can move freely in a second radial direction indicated by arrow 30, and the proximal coupler 18 can move freely in the second radial direction indicated by arrow 30, while the distal coupler 20 can move freely in the first radial direction indicated by arrow 28. In some cases, either the proximal coupler 18 and / or the distal coupler 20 can move freely in a different radial direction not indicated by arrows 28 and 30.

[0035] Moving to Figure 3, we can see that the distal coupler 20 is disengaged from the proximal coupler 18, but the distal coupler 20 remains fixed to the IMD 24. In some cases, the distal coupler 20 may be considered as part of the IMD 24 here. At this point, the elongated member 22 can be retracted proximally into the lumen 14 by either pulling the elongated member 22 proximally relative to the elongated sheath 12, or by pushing the elongated sheath 12 distally while holding the elongated member 22 stationary. The elongated sheath 12 (having the elongated member 22 and the proximal coupler 18) can then be retracted from the deployment site and from the patient. In some cases, the lumen 14 may instead be used to deliver another IMD.

[0036] Figure 4A is a perspective view of an exemplary coupler mechanism 100, and Figure 4B is an exploded perspective view of the exemplary coupler mechanism 100. The exemplary coupler mechanism 100 can be considered an example of a coupler mechanism 16. The coupler mechanism 100 includes a first coupler segment 102 and a second coupler segment 104. In some cases, the first coupler segment 102 may be an example of a proximal coupler 18, and the second coupler segment 104 may be an example of a distal coupler 20. The IMD 24 (not shown in Figure 4A or Figure 4B) can be considered to be adapted to be fixed to whichever of the first coupler segment 102 or the second coupler segment 104 is functioning as the distal coupler 20. The other of the first coupler segment 102 or the second coupler segment 104 can be considered to be adapted to be fixed to a long member 22 (not shown in Figure 4A or Figure 4B).

[0037] The first coupler segment 102 includes a projection 106 adapted to fit into a corresponding recess 108 formed within the second coupler segment 104. In some cases, as shown, the projection 106 is a trapezoidal projection and the corresponding recess 108 is a trapezoidal recess. In some cases, the projection 106 includes first support surfaces 106a and 106b, while the recess 108 includes support surfaces 108a and 108b. If any force is applied to the coupler mechanism 100 causing the first coupler segment 102 to move axially away from the second coupler segment 104, it will be understood that the first support surfaces 106a and 106b engage with the support surfaces 108a and 108b to resist their relative axial movement.

[0038] While the drawings show clear corners and edges, it should be understood that in some cases, corners and edges may be rounded as a result of manufacturing tolerances and to facilitate movement of components relative to one another. For example, to facilitate the engagement of the projection 106 into the corresponding recess 108 and eventually to move radially out of the recess 108. While some features are shown to be parallel to others, in some cases, the first coupler segment 102 and the second coupler segment 104 may not be formed as strictly as shown and instead may have further manufacturing tolerances.

[0039] Figures 4C and 4D are perspective views of the first coupler segment 102 and the second coupler segment 104, respectively, showing some of the dimensions of the projection 106 and recess 108. The projection 106 has a minimum width W1 and a maximum width W2, as shown in Figure 4C. The projection 106 has a depth or thickness D1 and a length L1. In some cases, W1 may range from 0.127 mm to 0.254 mm (0.005 inches to 0.010 inches). In some cases, W2 may range from 0.381 mm to 0.635 mm (0.015 inches to 0.025 inches). D1 may range from 0.178 mm to 0.444 mm (0.007 inches to 0.0175 inches). L1 may range from 0.254 mm to 0.508 mm (0.010 inches to 0.020 inches). In one example, W1 is 0.229 mm (0.009 inches), W2 is 0.483 mm (0.019 inches), D1 is 0.444 mm (0.0175 inches), and L1 is 0.381 mm (0.015 inches).

[0040] The recess 108 may have dimensions slightly larger than each of the corresponding dimensions of the projection 106 in order to allow the projection 106 to easily fit into the recess 108 in order to hold the first coupler segment 102 and the second coupler segment 104 together, while allowing for easy separation when separation is desired, as shown in Figure 4D. The recess 108 has a minimum width W3 and a maximum width W4 をThe recess 108 has a depth D2 and a length L2. In some cases, W3 may be in the range of 0.178 mm to 0.330 mm (0.007 inches to 0.013 inches). In some cases, W4 may be in the range of 0.508 mm to 0.711 mm (0.020 inches to 0.028 inches). D2 may be in the range of 0.178 mm to 0.444 mm (0.007 inches to 0.0175 inches). L2 may be in the range of 0.305 mm to 0.559 mm (0.012 inches to 0.022 inches). In one example, W3 is 0.305 mm (0.012 inches), W4 is 0.559 mm (0.022 inches), D2 is 0.444 mm (0.0175 inches), and L2 is 0.406 mm (0.016 inches). These dimensions may be selected to ensure that there is sufficient interaction between the projection 106 and the recess 108, so that the projection 106 remains within the recess 108 until separation is desired.

[0041] In some cases, the first coupler segment 102 and the second coupler segment 104 may have a maximum diameter of 0.838 mm (0.033 inches), and the length of each of the first coupler segment 102 and the second coupler segment 104 is 0.762 mm (0.030 inches). It will be understood that D1 and D2 are less than the maximum diameter. In some cases, D1 and D2 may be expressed as percentages of the maximum diameter. For example, D1 may be 10% of the maximum diameter, or 20%, 30%, or 40% of the maximum diameter. D2 may be 10 percent of the maximum diameter, or 20%, 30%, or 40 percent of the maximum diameter, provided that D2 is at least slightly larger than D1.

[0042] As a result, the projection 106 and recess 108 are adapted so that they can move radially away from each other in only specific directions. To separate, the first coupler segment 102 can move substantially out of the plane of the paper relative to the second coupler segment 104, and / or the second coupler segment 104 can move substantially inward from the plane of the paper relative to the first coupler segment 102, thereby disengaging the projection 106 from the recess 108.

[0043] Figure 5A is a side view of an exemplary coupler mechanism 110, and Figure 5B is an exploded side view of the exemplary coupler mechanism 110. The exemplary coupler mechanism 110 can be considered an example of a coupler mechanism 16. The coupler mechanism 110 includes a first coupler segment 112 and a second coupler segment 114. In some cases, the first coupler segment 112 may be an example of a proximal coupler 18, and the second coupler segment 114 may be an example of a distal coupler 20. The IMD 24 (not shown in Figure 5A or Figure 5B) may be considered to be adapted to be fixed to whichever of the first coupler segment 112 and the second coupler segment 114 is functioning as the distal coupler 20. The other of the first coupler segment 112 and the second coupler segment 114 may be considered to be adapted to be fixed to a long member 22 (not shown in Figure 5A or Figure 5B).

[0044] The first coupler segment 112 includes a projection 116 adapted to fit into a corresponding recess 118 formed within the second coupler segment 114. In some cases, as shown, the projection 116 is a rectilinear projection and the corresponding recess 118 is a rectilinear recess. In some cases, the projection 116 includes an annular support surface 116a, while the recess 118 includes an annular support surface 118a. If any force is applied to the coupler mechanism 110 that causes the first coupler segment 112 to move axially away from the second coupler segment 114, it will be understood that the annular support surface 116a engages with the annular support surface 118a to resist its relative axial movement. The projection 116 may include a support surface 116b that engages with the support surface 118b of the recess 118 when the first coupler segment 112 is moved toward the second coupler segment 114, thereby providing the ability to push through the coupler mechanism 110. It will be understood that when not radially constrained by an elongated sheath 12 or the like, the first coupler segment 112 and the second coupler segment 114 are free to move radially relative to each other.

[0045] In some cases, with respect to Figure 5B, the projection 116 may have a diameter of 0.178 mm to 0.245 mm (0.007 to 0.010 inches) and a length of 0.178 mm to 0.889 mm (0.007 to 0.035 inches). The support surface 116b may have a diameter of 0.245 mm to 0.457 mm (0.010 to 0.018 inches) and a length of 0.178 mm to 0.889 mm (0.007 to 0.035 inches). The dimensions of the support surface 116 depend on the dimensions of the projection 116 and the support surface 116b. The dimensions of the annular support surface 118a depend on the dimensions of the recess 118 and the support surface 118b.

[0046] Figure 6A is a perspective view of an exemplary coupler mechanism 120, and Figure 6B is an exploded perspective view of the exemplary coupler mechanism 120. The exemplary coupler mechanism 120 can be considered an example of a coupler mechanism 16. The coupler mechanism 120 includes a first coupler segment 122 and a second coupler segment 124. In some cases, the first coupler segment 122 may be an example of a proximal coupler 18, and the second coupler segment 124 may be an example of a distal coupler 20. The IMD 24 (not shown in Figure 6A or Figure 6B) may be considered to be adapted to be fixed to whichever of the first coupler segment 122 or the second coupler segment 124 is functioning as the distal coupler 20. The other of the first coupler segment 122 or the second coupler segment 124 may be considered to be adapted to be fixed to a long member 22 (not shown in Figure 6A or Figure 6B).

[0047] The first coupler segment 122 includes a projection 126 adapted to fit into a corresponding recess 128 formed within the second coupler segment 124. In some cases, as shown, the projection 126 is a frustoconical projection, and the corresponding recess 128 is adapted to accommodate the projection 126. In some cases, the projection 126 includes a conical support surface 126a, and the recess 128 includes a first support surface 128a and a second support surface 128b. If any force is applied to the coupler mechanism 120 that causes the first coupler segment 122 to move axially away from the second coupler segment 124, it will be understood that the conical support surface 126a engages with the annular support surfaces 128a and 128b to resist its relative axial movement. The projection 126 may include a support surface 126b that engages with the support surface 128c of the recess 128 when the first coupler segment 122 is moved toward the second coupler segment 124, thereby providing the ability to push through the coupler mechanism 120. It will be understood that when not radially constrained by an elongated sheath 12 or the like, the first coupler segment 122 and the second coupler segment 124 are free to move radially relative to each other.

[0048] Figure 7A is a perspective view of an exemplary coupler mechanism 130, and Figure 7B is an exploded perspective view of the exemplary coupler mechanism 130. The exemplary coupler mechanism 130 can be considered an example of a coupler mechanism 16. The coupler mechanism 130 includes a first coupler segment 132 and a second coupler segment 134. In some cases, the first coupler segment 132 may be an example of a proximal coupler 18, and the second coupler segment 134 may be an example of a distal coupler 20. The IMD 24 (not shown in Figure 7A or Figure 7B) can be considered to be adapted to be fixed to whichever of the first coupler segment 132 or the second coupler segment 134 is functioning as the distal coupler 20. The other of the first coupler segment 132 or the second coupler segment 134 can be considered to be adapted to be fixed to a long member 22 (not shown in Figure 7A or Figure 7B).

[0049] The first coupler segment 132 includes a projection 136 adapted to fit into a corresponding recess 138 formed within the second coupler segment 134. In some cases, as shown, the projection 136 is bulbous, and the corresponding recess 138 is adapted to accommodate the projection 136. In some cases, the projection 136 includes a spherical support surface 136a, and the recess 138 includes a first support surface 138a and a second support surface 138b. If any force is applied to the coupler mechanism 130 that causes the first coupler segment 132 to move axially away from the second coupler segment 134, it will be understood that the conical support surface 136a engages with the annular support surfaces 138a and 138b to resist its relative axial movement. The projection 136 may include a support surface 136b that engages with the support surface 138c of the recess 138 when the first coupler segment 132 is moved toward the second coupler segment 134, thereby providing the ability to push through the coupler mechanism 130. It will be understood that when not radially constrained by an elongated sheath 12 or the like, the first coupler segment 132 and the second coupler segment 134 are free to move radially relative to each other.

[0050] The various components of the medical device systems disclosed herein and the materials that can be used for those various components may include those generally associated with medical devices. In some embodiments, the medical device systems disclosed herein may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels such as 444V, 444L, and 314LV stainless steel; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic Nitinol; and other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22, HASTELLOY® C UNS:N10276 (e.g., 276), other HASTELLOY® alloys, nickel-copper alloys (e.g., UNS:N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035, such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY Examples include UNS:N100665 (e.g., B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R44003, such as ELGILOY® and PHYNOX®); platinum-reinforced stainless steel; titanium; combinations thereof, etc.; or any other suitable material.

[0051] As suggested herein, within the family of commercially available nickel-titanium alloys or nitinol alloys, there is a category referred to as “linear elastic” or “non-superelastic,” which may be chemically similar to conventional shape-memory and superelastic species but may exhibit distinct useful mechanical properties. Linear elastic and / or non-superelastic nitinol can be distinguished from superelastic nitinol in that, in its stress / strain curve, it does not exhibit a substantial “superelastic plateau” or “flag region” as superelastic nitinol exhibits. Instead, in linear elastic and / or non-superelastic nitinol, as the recoverable strain increases, the stress continues to increase substantially linearly, or somewhat but not necessarily perfectly linearly, or at least more linearly than the superelastic plateau and / or flag region that may be seen in superelastic nitinol, until plastic deformation begins. Thus, for the purposes of this disclosure, linear elastic and / or non-superelastic nitinol may also be referred to as “substantially” linear elastic and / or non-superelastic nitinol.

[0052] In some cases, linear elastic and / or non-hyperelastic nitinol can tolerate up to approximately 2–5% strain while remaining substantially elastic (e.g., before plastic deformation), while hyperelastic nitinol can tolerate up to approximately 8% strain before plastic deformation. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (which can also be distinguished based on its composition), which can tolerate only about 0.2–0.44 percent strain before plastic deformation.

[0053] In some embodiments, linear elastic and / or non-hyperelastic nickel-titanium alloys are alloys that do not exhibit martensite / austenite phase transitions detectable by differential scanning calorimetry (DSC) and dynamic metallic thermal analysis (DMTA) over a wide temperature range. For example, in some embodiments, linear elastic and / or non-hyperelastic nickel-titanium alloys may not exhibit martensite / austenite phase transitions detectable by DSC and DMTA analysis in the range of about -60°C to about 120°C. Therefore, the mechanical bending properties of such materials may, in general, be inert to the effects of temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-hyperelastic nickel-titanium alloys at ambient or room temperature are substantially the same as their mechanical properties at body temperature, for example, in that they do not exhibit hyperelastic plateaus and / or flag regions. In other words, linear elastic and / or non-hyperelastic nickel-titanium alloys maintain their linear elastic and / or non-hyperelastic properties and / or characteristics over a wide temperature range.

[0054] In some embodiments, the linearly 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 essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. An example of a suitable nickel-titanium alloy is the FHP-NT alloy, commercially available from Furukawa Techno Material Co., Ltd., Kanagawa Prefecture, Japan. Other suitable materials include ULTANIUM® (available from Neo-Metrics) and GUM METAL® (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic nitinol, may be used to achieve the desired properties.

[0055] In at least some embodiments, some or all of the medical device systems described herein may also be doped with, fabricated from, or otherwise incorporate radiopaque materials. Radiopaque materials are understood to be materials that can produce a relatively bright image on a fluoroscopic screen or other imaging technique during a medical procedure. This relatively bright image helps the user determine the location of the medical device system. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, and polymer materials loaded with radiopaque fillers. Furthermore, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device systems described herein.

[0056] In some embodiments, a certain degree of magnetic resonance imaging (MRI) compatibility is imparted to the medical device systems described herein. The medical devices described herein may be made from materials that do not substantially distort images and do not produce substantial artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they can produce artifacts in MRI images. In some cases, the medical device system or a part thereof may be made from 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 ELGILOY® and PHYNOX®), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035 such as MP35-N®), nitinol, and others.

[0057] In some embodiments, the medical device systems described herein may be made from or include polymers or other suitable materials. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethane (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as HYTREL® available from DuPont), and polyamides (e.g., DURETHAN® or Elf available from Bayer). CRISTAMID® (trademark) available from Atochem, elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex® high-density polyethylene, Marlex® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon 12 (EMS American)Examples include GRILAMID® (available from Grilon), perfluoro(propyl vinyl ether) (PFA), ethyl vinyl alcohol, polyolefins, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof. In some embodiments, the sheath may be mixed with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0058] In some embodiments, the medical device systems and / or other elements disclosed herein may include a woven material placed on or within the structure. The woven material may consist of biocompatible materials such as polymer materials or biomaterials adapted to promote tissue endothelial growth. In some embodiments, the woven material may include bioabsorbable materials. Some examples of suitable woven materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials such as polyethylene, polypropylene, polyester, polyurethane, and / or blends or combinations thereof.

[0059] It should be understood that this disclosure is illustrative in many respects. Modifications can be made in detail, particularly with respect to shape, size, and step arrangement, without exceeding the scope of the invention. This may include, to a suitable extent, the use of any feature of one exemplary embodiment used in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

Claims

1. A medical device system, A long sheath, which defines a lumen extending within the long sheath, A coupler mechanism, including a proximal coupler and a distal coupler, is slidably disposed within the lumen. A long, elongated member is fixed to the proximal coupler and extends proximal to the proximal coupler, The system comprises an implantable medical device (IMD) fixed to the distal coupler and extending distally from the distal coupler, The distal coupler remains fixed to the proximal coupler while the coupler mechanism remains within the lumen. The distal coupler is released from the proximal coupler when the coupler mechanism is outside the lumen, thereby releasing the IMD. The proximal coupler comprises an axial extension portion extending distally from the elongated member and a protruding portion separated from the elongated member by the axial extension portion. A medical device system comprising: a distal coupler having a recess formed therein, the recess being complementary to the protrusion so that the protrusion fits into the recess; and a channel extending axially from the nearest end of the distal coupler to the recess, the channel configured to receive the axial extension of the proximal coupler.

2. The medical device system according to claim 1, wherein the coupler mechanism is adapted to be moved outside the lumen by retracting the elongated sheath proximal to it while holding the elongated member in a stationary state.

3. The medical device system according to claim 1, wherein the coupler mechanism is adapted to move outside the lumen by extending the elongated member distally while holding the elongated sheath proximally.

4. The medical device system according to claim 1, wherein the coupler mechanism is adapted to allow relative radial movement when not particularly constrained by the elongated sheath, while restricting relative axial movement between the distal coupler and the proximal coupler.

5. The medical device system according to claim 1, wherein the distal coupler comprises a first support surface, and the proximal coupler comprises a second support surface, and the first support surface engages with the second support surface to restrict relative axial movement between them.

6. The medical device system according to claim 1, wherein the coupler mechanism is adapted so that distal movement of the elongated member is transmitted to the IMD via the coupler mechanism while the IMD remains fixed to the distal coupler.

7. The medical device system according to claim 1, wherein the coupler mechanism is adapted so that the proximal movement of the elongated member is transmitted to the IMD via the coupler mechanism while the IMD remains fixed to the distal coupler.

8. The medical device system according to claim 1, wherein the protrusion is adapted to slide radially within the recess which is complementary to the protrusion.

9. The medical device system according to claim 1, wherein the projection comprises one of a trapezoidal projection, a linear projection, a frustoconical projection, or a bulbous projection.

10. A system for delivering embolic coils, A long sheath, which defines a lumen extending within the long sheath, A long, elongated member extending through the lumen, The system includes a coupler mechanism slidably positioned within the lumen and releasably connecting the embolus coil to the elongated member, The coupler mechanism is adapted to prevent the embolus coil from separating from the elongated member while the coupler mechanism is radially restrained by the elongated sheath. The coupler mechanism is adapted to allow the embolus coil to separate from the elongated member when the coupler mechanism is no longer radially constrained by the elongated sheath. The aforementioned coupler mechanism is A first coupler segment fixed to the elongated member, The embolus coil is equipped with a second coupler segment fixed to it, The first coupler segment is an axial extension that extends distally to the protrusion, and the protrusion is provided with an axial extension that is separated from the elongated member by the axial extension. The system comprises a second coupler segment having a recess formed therein, the recess being complementary to the protrusion so that the protrusion fits into the recess, and a channel extending distally from the nearest end of the second coupler segment to the recess, the channel configured to receive the axial extension of the first coupler segment.

11. The system according to claim 10, wherein the first coupler segment is adapted to engage with the second coupler segment and restrict relative axial movement between them when the coupler mechanism is radially constrained by the elongated sheath.

12. The system according to claim 10, wherein the first coupler segment is adapted to disengage from the second coupler segment when the coupler mechanism is not radially constrained by the elongated sheath, thereby freeing the embolus coil from the elongated member.

13. It is an embolization treatment system, A long sheath, which defines a lumen extending within the long sheath, A coupler mechanism, including a proximal coupler and a distal coupler, is slidably disposed within the lumen. A long, elongated member is fixed to the proximal coupler and extends proximal to the proximal coupler, The system comprises an embolic coil fixed to the distal coupler and extending distally from the distal coupler, The distal coupler remains fixed to the proximal coupler while the coupler mechanism remains within the lumen. The distal coupler is released from the proximal coupler when the coupler mechanism is outside the lumen, thereby releasing the embolic coil and the proximal coupler. The proximal coupler comprises an axial extension portion extending distally from the elongated member and a protruding portion separated from the elongated member by the axial extension portion. Embolization treatment system comprising: a distal coupler having a recess formed therein, the recess being complementary to the protrusion so as to fit the protrusion into the recess; and a channel extending axially from the nearest end of the distal coupler to the recess, the channel configured to receive the axial extension of the proximal coupler.

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