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] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and methods for making and / or using medical devices. More particularly, the present disclosure relates to the configuration of a system for releasing a medical implant. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical applications, e.g., surgical and / or intravascular 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 can be manufactured by any one of a variety of different manufacturing methods and 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 configurations of systems for releasing medical implants. One example can be found in a medical device system. 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 the proximal coupler and extends proximally from the proximal coupler. An implantable medical device (IMD) is secured to the distal coupler and extends distally from the distal coupler. The distal coupler remains secured to the proximal coupler while the coupler mechanism remains within the lumen, and when the coupler mechanism is outside of 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 be moved out of the lumen by proximally retracting the elongate sheath while holding the elongate member stationary.

[0005] Alternatively, or in addition, the coupler mechanism may be adapted to be moved out of the lumen by extending the elongate member distally while holding the elongate sheath proximally.

[0006] Alternatively, or in addition, the coupler mechanism may be adapted to limit relative axial movement between the distal and proximal couplers, while allowing relative radial movement when not specifically constrained by the elongate sheath.

[0007] Alternatively, or in addition, the distal coupler may include a first bearing surface and the proximal coupler may include a second bearing surface, the first bearing surface engaging the second support surface to limit relative axial movement therebetween.

[0008] Alternatively, or in addition, the coupler mechanism may be adapted such that distal movement of the elongate 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 proximal movement of the elongate 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 protrusion and the other of the distal coupler and the proximal coupler may include a recess, the recess being complementary to the protrusion such that the protrusion fits within the recess.

[0011] Alternatively, or in addition, the protrusion may be adapted to slide radially into the recess that is complementary to the protrusion. Alternatively, or in addition, the protrusion may include a trapezoidal protrusion.

[0012] Alternatively, or in addition, the protrusions may include linear protrusions. Alternatively, or in addition, the protrusion may include a frusto-conical protrusion. Alternatively, or in addition, the protrusions may include bulbous protrusions.

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

[0014] Alternatively, or in addition, the coupler mechanism may include a first coupler segment secured to the elongate member and a second coupler segment secured to the embolic coil.

[0015] Alternatively, or in addition, the first coupler segment may be adapted to engage the second coupler segment and limit relative axial movement therebetween when the coupler mechanism is radially constrained by the elongate 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 elongate sheath, thereby releasing the embolic coil from the elongate member.

[0017] Alternatively, or in addition, the second coupler segment may remain fixed to the embolic coil when the embolic coil is released from the elongate member. Another example can be found in an embolic therapy system that includes an elongate sheath defining a lumen extending within the elongate sheath, a coupler mechanism slidably disposed within the lumen and including a proximal coupler and a distal coupler, an elongate member secured to the proximal coupler and extending proximally from the proximal coupler, and an embolic coil secured to the distal coupler and extending distally from the distal coupler, the distal coupler remaining secured 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 of the lumen, thereby releasing the embolic coil and the proximal coupler.

[0018] The above summary of some embodiments, aspects, and / or examples is not intended to describe each embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. [Brief description of the drawings]

[0019] The present disclosure may be more fully understood from the consideration of the following detailed description of various embodiments in conjunction with the accompanying drawings, in which: [Figure 1] 1 is a schematic side view of an exemplary delivery device for delivering an implantable medical device (IMD), showing the IMD within the delivery device. [Diagram 2] 2 is a schematic side view of the exemplary delivery device of FIG. 1 showing an IMD released from the delivery device. [Diagram 3] 2 is a schematic side view of the exemplary delivery device of FIG. 1 showing the IMD removed from the delivery device. [Figure 4A] 2 is 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] FIG. 4B is a perspective view of the example coupler mechanism of FIG. 4A with the two coupler segments separated from one another. [Figure 4C] 4B is a perspective view of a first coupler segment forming part of the example coupler mechanism of FIG. 4A. [Figure 4D] 4B is a perspective view of a second coupler segment forming part of the example coupler mechanism of FIG. 4A. [Figure 5A] 2 is 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] FIG. 5B is a side view of the example coupler mechanism of FIG. 5A with the two coupler segments separated from one another. [Figure 6A] 2 is 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] FIG. 6B is a perspective view of the example coupler mechanism of FIG. 6A with the two coupler segments separated from one another. [Figure 7A] 2 is 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] FIG. 7B is a perspective view of the example coupler mechanism of FIG. 7A with the two coupler segments separated from one another.

[0020] While aspects of the disclosure are susceptible to various modifications and alternative forms, details of which 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 disclosure 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 OF THE PREFERRED EMBODIMENTS

[0021] The following description should be read with reference to the drawings, which are not necessarily to scale, and in which like reference numerals refer to like elements throughout the several views. The detailed description and drawings are intended to illustrate, but not to limit, the claimed invention. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of the present disclosure. The detailed description and drawings show exemplary embodiments of the claimed invention.

[0022] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​are assumed to be modified by the term "about" in this specification, whether or not expressly indicated. The term "about" in the context of numerical values ​​generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated 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. Other uses of the term "about" (e.g., in contexts other than numerical values) may be assumed to have their normal customary definitions as understood from and consistent with the context of this specification, unless otherwise specified.

[0023] The recitation of numerical ranges by endpoints includes all numbers within that range, including 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 ​​for various components, features, and / or specifications have been disclosed, one of ordinary skill in the art, encouraged by this disclosure, will understand that the desired dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0024] 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 used generally in the sense of including "and / or," unless the content clearly dictates otherwise. For ease of understanding, it should be noted that certain features of the present disclosure may be described in the singular even though those features may be multiple or repeated within the disclosed embodiments. Each instance of a feature may include and / or be encompassed by the singular disclosure unless expressly stated otherwise. For simplicity 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 description may apply equally to any and / or all of the components present in more than one unless expressly stated otherwise. Moreover, for clarity, not all instances of some elements or features are shown in each figure.

[0025] Relative terms such as "proximal," "distal," "advance," "retract," and variations thereof may generally be considered with respect to the positioning, orientation, and / or movement of various elements relative to a user / operator / manipulator of the device, with "proximal" and "retract" indicating or referring to being closer to or toward the user, and "distal" and "advance" indicating or referring to being farther from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned to facilitate understanding of the present disclosure, and such instances will be readily apparent to one of ordinary skill in the art. Other relative terms such as "upstream," "downstream," "inflow," and "outflow" refer to the direction of fluid flow within a body lumen, a lumen such as a blood vessel, or within a device.

[0026] The term "range" may be understood to mean the maximum measurement of a stated or specified dimension. For example, an "outer range" may be understood to mean the maximum outer dimension, a "radial range" may be understood to mean the maximum radial dimension, a "longitudinal range" may be understood to mean the maximum longitudinal dimension, etc. Each instance of "range" may be different (e.g., axially, longitudinally, laterally, radially, circumferentially, etc.) and will be clear to one of skill in the art from the context of the particular usage. In general, "range" may be considered the maximum possible dimension measured according to the intended use. In some cases, "range" may be generally measured orthogonally in a plane and / or cross section, but may also be measured differently, such as, but not limited to, angularly, radially, circumferentially (e.g., along an arc), as will be clear from the particular context.

[0027] It should be noted that references herein to "embodiments," "some embodiments," "other embodiments," and the like, indicate that the described embodiment may include a particular feature, structure, or characteristic, but that not all embodiments necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, if a particular feature, structure, or characteristic is described in relation to one embodiment, it would be within the knowledge of one of ordinary skill in the art to effect the particular feature, structure, or characteristic in relation to other embodiments, unless expressly stated otherwise, whether or not explicitly described. That is, it is contemplated that the various individual elements described below, even if not explicitly shown in a particular combination, can be combined or arranged with one another to form other additional embodiments, or to complement and / or enhance the described embodiments, as would be understood by one of ordinary skill 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 features of the various descriptions and / or claims. It should be understood that the numerical nomenclature is not intended to be limiting, but is merely exemplary. In some embodiments, modifications and departures from previously used numerical nomenclature may be made for brevity and clarity. That is, a feature identified as a "first" element may later be referred to as a "second" element, a "third" element, etc., or may be omitted entirely, and / or a different feature may be referred to as the "first" element. The meaning and / or name in each example will be apparent to one of ordinary skill in the art.

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

[0030] Some internal components are shown diagrammatically in phantom. The coupler mechanism 16 is slidably disposed 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 secured to an elongate member 22, which may be manipulated at a proximal end (not shown) of the medical device system 10, for example, to move the elongate member 22, and thus the coupler mechanism 16, axially within the lumen 14. In some cases, the proximal coupler 18 may be secured to the elongate member 22 by laser welding, soldering, swaging, crimping, or bonding a proximal end of the proximal coupler 18 to the elongate member 22. The distal coupler 20 may be secured to the IMD 24, and in some cases remains secured to the IMD 24 even after the IMD 24 is deployed.

[0031] The proximal coupler 18 and the distal coupler 20 may be formed of any suitable material. In some cases, the proximal coupler 18 and the distal coupler 20 may be formed of platinum, iridium, stainless steel, or another biocompatible material. The proximal coupler 18 and the distal coupler 20 may be manufactured using laser ablation to ablate material from the stock used to produce the proximal coupler 18 and the distal coupler 20. In some cases, micromachining may be used to manufacture the proximal coupler 18 and the distal coupler 20. In some cases, a combination of additive and subtractive manufacturing may be used in making the proximal coupler 18 and / or the 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 secured together until release of the IMD 24 is desired. For example, the proximal coupler 18 and the distal coupler 20 may be adapted to engage one another to allow axial movement of the coupler mechanism 16 within the lumen 14 for as long as the coupler mechanism 16 remains within the lumen 14. The proximal coupler 18 and the distal coupler 20 may be adapted to disengage from one another when the coupler mechanism 16, or at least a portion thereof, moves to a position outside the lumen 14. In some cases, the proximal coupler 18 and the distal coupler 20 are adapted to remain engaged to one another when the proximal coupler 18 and the distal coupler 20 are restrained from relative radial movement, including being radially restrained by the elongate sheath 12.

[0033] The coupler mechanism 16 may be adapted such that axial movement of the elongate member 22 is transferred through the coupler mechanism 16 to the IMD 24 while the coupler mechanism 16 remains within the lumen 14. For example, the elongate member 22 may be pushed distally relative to the elongate sheath 12 to move the IMD 24 distally. The elongate member 22 may be pulled proximally relative to the elongate sheath 12 to move the IMD 24 proximally. The elongate member 22 may be held stationary while the elongate sheath 12 is pulled proximally to move the distal end 26 of the elongate sheath 12 closer to the IMD 24. The elongate member 22 may be held stationary while the elongate sheath 12 is pushed distally to move the distal end 26 of the elongate sheath 12 further away from the IMD 24.

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

[0035] Turning to FIG. 3, it can be seen that the distal coupler 20 has been 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 now be considered part of the IMD 24. At this point, the elongate member 22 may be retracted proximally into the lumen 14, either by pulling the elongate member 22 proximally relative to the elongate sheath 12, or by pushing the elongate sheath 12 distally while holding the elongate member 22 stationary. The elongate sheath 12 (with the elongate member 22 and proximal coupler 18) may 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] 4A is a perspective view of an exemplary coupler mechanism 100, and FIG. 4B is an exploded perspective view of the exemplary coupler mechanism 100. The exemplary coupler mechanism 100 may be considered to be 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 FIG. 4A or FIG. 4B) may be considered to be adapted to be secured to either the first coupler segment 102 or the second coupler segment 104, whichever is functioning as the distal coupler 20. The other of the first coupler segment 102 or the second coupler segment 104 may be considered to be adapted to be secured to the elongate member 22 (not shown in FIG. 4A or FIG. 4B).

[0037] The first coupler segment 102 includes a protrusion 106 adapted to fit within a corresponding recess 108 formed in the second coupler segment 104. In some cases, as shown, the protrusion 106 is a trapezoidal protrusion and the corresponding recess 108 is a trapezoidal recess. In some cases, the protrusion 106 includes first bearing surfaces 106a and 106b, while the recess 108 includes bearing surfaces 108a and 108b. It will be appreciated that if any force is applied to the coupler mechanism 100 tending to axially move the first coupler segment 102 away from the second coupler segment 104, the first bearing surfaces 106a and 106b will engage the bearing surfaces 108a and 108b to resist the relative axial movement thereof.

[0038] While the drawings show sharp corners and edges, it should be understood that in some cases, the corners and edges may be rounded as a result of manufacturing tolerances as well as to make it easier for components to move relative to one another, such as to make it easier for protrusions 106 to fit into corresponding recesses 108 and ultimately move radially out of recesses 108. Although some features are shown as being parallel to other features, in some cases, first coupler segment 102 and second coupler segment 104 may not be formed exactly as shown, and instead may have additional manufacturing tolerances.

[0039] 4C and 4D are perspective views of the first and second coupler segments 102 and 104, respectively, illustrating some of the dimensions of the protrusion 106 and recess 108. The protrusion 106 has a minimum width W 1 and maximum width W 2 The protrusion 106 has a depth or thickness D 1 and length L 1 In some cases, W 1 may be in the range of 0.005 inches to 0.010 inches. 2 may be in the range of 0.381 mm to 0.635 mm (0.015 inches to 0.025 inches). 1 may range from 0.178 mm to 0.444 mm (0.007 inches to 0.0175 inches). 1 may be in the range of 0.254 mm to 0.508 mm (0.010 inches to 0.020 inches). 1 is 0.229 mm (0.009 inches), and W 2 is 0.483 mm (0.019 inches), and D 1 is 0.444 mm (0.0175 inches), and L 1 is 0.381 mm (0.015 inches).

[0040] The recesses 108 may have dimensions slightly larger than each of the corresponding dimensions of the protrusions 106 to allow the protrusions 106 to easily fit within the recesses 108 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 FIG. 3 and maximum width W4 を The recess 108 has a depth D 2 and length L 2 In some cases, W3 may be in the range of 0.178 mm to 0.330 mm (0.007 inches to 0.013 inches). 4 may be in the range of 0.508 mm to 0.711 mm (0.020 inches to 0.028 inches). 2 may range from 0.178 mm to 0.444 mm (0.007 inches to 0.0175 inches). 2 may be in the range of 0.305 mm to 0.559 mm (0.012 inches to 0.022 inches). 3 is 0.305 mm (0.012 inches), and W 4 is 0.559 mm (0.022 inches), and D 2 is 0.444 mm (0.0175 inches), and L 2 is 0.016 inches (0.406 mm). These dimensions may be selected to ensure that there is sufficient interaction between the protrusions 106 and the recesses 108 to ensure that the protrusions 106 remain within the recesses 108 until such time as separation is desired.

[0041] In some cases, the first coupler segment 102 and the second coupler segment 104 may have a maximum diameter of 0.033 inches and the length of each of the first coupler segment 102 and the second coupler segment 104 is 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 a percentage of the maximum diameter. For example, D1 may be 10% of the maximum diameter, or 20%, or 30%, or 40% of the maximum diameter. D2 may be 10 percent of the maximum diameter, or 20 percent, or 30 percent, or 40 percent of the maximum diameter, provided that D2 is at least slightly larger than D1.

[0042] As a result, the protrusions 106 and recesses 108 are adapted such that they can only radially separate in certain 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 into the plane of the paper relative to the first coupler segment 102, thereby disengaging the protrusions 106 from the recesses 108.

[0043] 5A is a side view of the exemplary coupler mechanism 110, and FIG. 5B is an exploded side view of the exemplary coupler mechanism 110. The exemplary coupler mechanism 110 may be considered to be an example of the 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 the proximal coupler 18, and the second coupler segment 114 may be an example of the distal coupler 20. The IMD 24 (not shown in FIG. 5A or FIG. 5B) may be considered to be adapted to be secured to either the first coupler segment 112 or the second coupler segment 114, whichever serves as the distal coupler 20. The other of the first coupler segment 112 or the second coupler segment 114 may be considered to be adapted to be secured to the elongate member 22 (not shown in FIG. 5A or FIG. 5B).

[0044] The first coupler segment 112 includes a protrusion 116 adapted to fit within a corresponding recess 118 formed in the second coupler segment 114. In some cases, as shown, the protrusion 116 is a rectilinear protrusion and the corresponding recess 118 is a rectilinear recess. In some cases, the protrusion 116 includes an annular bearing surface 116a, while the recess 118 includes an annular bearing surface 118a. It will be appreciated that if any force is applied to the coupler mechanism 110 tending to axially move the first coupler segment 112 away from the second coupler segment 114, the annular bearing surface 116a will engage the annular bearing surface 118a to resist their relative axial movement. The protrusion 116 may be considered to include a bearing surface 116b that engages a bearing surface 118b of the recess 118 when the first coupler segment 112 is moved towards the second coupler segment 114, thereby providing pushability through the coupler mechanism 110. It will be appreciated that when not radially constrained by the elongate sheath 12 or the like, the first coupler segment 112 and the second coupler segment 114 are free to move radially relative to one another.

[0045] In some cases, with reference to FIG. 5B, the protrusion 116 may have a diameter of 0.007-0.010 inches and a length of 0.007-0.035 inches. The support surface 116b may have a diameter of 0.010-0.018 inches and a length of 0.007-0.035 inches. The dimensions of the support surface 116 depend on the dimensions of the protrusion 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] 6A is a perspective view of an exemplary coupler mechanism 120, and FIG. 6B is an exploded perspective view of the exemplary coupler mechanism 120. The exemplary coupler mechanism 120 may be considered to be an example of the 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 the proximal coupler 18, and the second coupler segment 124 may be an example of the distal coupler 20. The IMD 24 (not shown in FIG. 6A or FIG. 6B) may be considered to be adapted to be secured to either the first coupler segment 122 or the second coupler segment 124, whichever serves 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 secured to the elongate member 22 (not shown in FIG. 6A or FIG. 6B).

[0047] The first coupler segment 122 includes a protrusion 126 adapted to fit within a corresponding recess 128 formed in the second coupler segment 124. In some cases, as shown, the protrusion 126 is a frusto-conical protrusion and the corresponding recess 128 is adapted to receive the protrusion 126. In some cases, the protrusion 126 includes a conical support surface 126a and the recess 128 includes a first support surface 128a and a second support surface 128b. It will be appreciated that if any force is applied to the coupler mechanism 120 to axially move the first coupler segment 122 away from the second coupler segment 124, the conical support surface 126a engages the annular support surfaces 128a and 128b to resist the relative axial movement thereof. The protrusion 126 may be considered to include a bearing surface 126b that engages a bearing surface 128c of the recess 128 when the first coupler segment 122 is moved towards the second coupler segment 124, thereby providing pushability through the coupler mechanism 120. It will be appreciated that when not radially constrained by the elongate sheath 12 or the like, the first coupler segment 122 and the second coupler segment 124 are free to move radially relative to one another.

[0048] 7A is a perspective view of an exemplary coupler mechanism 130, and FIG. 7B is an exploded perspective view of the exemplary coupler mechanism 130. The exemplary coupler mechanism 130 may be considered to be an example of the 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 the proximal coupler 18, and the second coupler segment 134 may be an example of the distal coupler 20. The IMD 24 (not shown in FIG. 7A or FIG. 7B) may be considered to be adapted to be secured to either the first coupler segment 132 or the second coupler segment 134, whichever serves as the distal coupler 20. The other of the first coupler segment 132 or the second coupler segment 134 may be considered to be adapted to be secured to the elongate member 22 (not shown in FIG. 7A or FIG. 7B).

[0049] The first coupler segment 132 includes a protrusion 136 adapted to fit within a corresponding recess 138 formed in the second coupler segment 134. In some cases, as shown, the protrusion 136 is a bulbous protrusion and the corresponding recess 138 is adapted to receive the protrusion 136. In some cases, the protrusion 136 includes a spherical bearing surface 136a and the recess 138 includes a first bearing surface 138a and a second bearing surface 138b. It will be appreciated that if any force is applied to the coupler mechanism 130 to axially move the first coupler segment 132 away from the second coupler segment 134, the conical bearing surface 136a will engage the annular bearing surfaces 138a and 138b to resist the relative axial movement thereof. The protrusion 136 may be considered to include a bearing surface 136b that engages a bearing surface 138c of the recess 138 when the first coupler segment 132 is moved towards the second coupler segment 134, thereby providing pushability through the coupler mechanism 130. It will be appreciated that when not radially constrained by the elongate sheath 12 or the like, the first coupler segment 132 and the second coupler segment 134 are free to move radially relative to one another.

[0050] Materials that can be used for the various components and elements of the medical device systems disclosed herein 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, and the like, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels, such as 444V, 444L, and 314LV stainless steels; mild steels; nickel-titanium alloys, such as linear elastic and / or superelastic Nitinol; other nickel alloys, such as nickel-chromium-molybdenum alloys (e.g., UNS:N06625, such as INCONEL® 625, UNS:N06022, such as HASTELLOY® C-22, UNS:N06024, such as HASTELLOY® C-22, UNS:N06026, such as HASTELLOY® C-22, UNS:N06028 ... 276, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400, such as MONEL® 400, NICKELVAC™ 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R44035, such as MP35-N™), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY®, etc.), 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, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as ELGILOY®, PHYNOX®); platinum strengthened stainless steels; titanium; combinations thereof, and the like; or any other suitable material.

[0051] As alluded to herein, within the family of commercially available nickel-titanium or nitinol alloys, there is a category termed "linear elastic" or "non-superelastic" which may be chemically similar to conventional shape memory and superelastic species, but may exhibit distinct and useful mechanical properties. Linear elastic and / or non-superelastic nitinol may be distinguished from superelastic nitinol in that linear elastic and / or non-superelastic nitinol does not exhibit a substantial "superelastic plateau" or "flag region" in its stress / strain curve as does superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or somewhat but not necessarily completely linear, relationship, or at least a relationship that is more linear than the superelastic plateau and / or flag region that may be seen in superelastic nitinol, until plastic deformation begins. Thus, for 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-superelastic Nitinol may also be distinguished from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol can tolerate up to about 2-5% strain while remaining substantially elastic (e.g., before plastic deformation), whereas superelastic Nitinol can tolerate up to about 8% strain before plastic deformation. Both of these materials may be distinguished from other linear elastic materials, such as stainless steel (which may also be distinguished based on its composition), which can only tolerate about 0.2-0.44 percent strain before plastic deformation.

[0053] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not exhibit a martensite / austenite phase change detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a wide temperature range. For example, in some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may not have a martensite / austenite phase change detectable by DSC and DMTA analysis in the range of about -60°C to about 120°C. Thus, the mechanical bending properties of such materials may be generally inert to the effects of temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of the linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not exhibit a superelastic plateau and / or flag region. In other words, over a wide temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or characteristics.

[0054] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may range from about 50 to about 60 weight percent nickel, with the remainder essentially titanium. In some embodiments, the composition ranges from about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy, available from Furukawa Techno Materials, Inc., Kanagawa, 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, made from, or otherwise include radiopaque materials. A radiopaque material is understood to be a material that can produce a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user in determining the location of the medical device system. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Additionally, 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 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 create substantial artifacts (e.g., gaps in images). For example, certain ferromagnetic materials may not be suitable because they may create artifacts in MRI images. In some cases, the medical device system or portions thereof may be made from materials that MRI machines can image. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R44003, such as ELGILOY®, 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), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics). Atochem's CRISTAMID™), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, available, for example, under the trade name PEBAX™), ethylene vinyl acetate copolymers (EVA), silicones, 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 AmericanSuch materials include GRILAMID® available from Grillon, perfluoro(propyl vinyl ether) (PFA), ethyl vinyl alcohol, polyolefins, polystyrene, epoxies, 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, and the like. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the blend may contain up to about 6% LCP.

[0058] In some embodiments, the medical device systems described herein and / or other elements disclosed herein may include a woven material disposed on or within the structure. The woven material may be comprised of a biocompatible material, such as a polymeric material or a biomaterial adapted to promote tissue ingrowth. In some embodiments, the woven material may include a bioabsorbable material. 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 will be understood that this disclosure is in many respects merely 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, to the extent appropriate, the use of any of the features of one illustrative 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. 1. A medical device system, comprising: an elongate sheath defining a lumen extending therethrough; a coupler mechanism slidably disposed within the lumen, the coupler mechanism including a proximal coupler and a distal coupler; an elongate member secured to the proximal coupler and extending proximally from the proximal coupler; an implantable medical device (IMD) secured to 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 disengaged from the proximal coupler when the coupler mechanism is outside the lumen, thereby releasing the IMD.

2. The medical device system of claim 1 , wherein the coupler mechanism is adapted to be moved out of the lumen by proximally retracting the elongate sheath while holding the elongate member stationary.

3. The medical device system of claim 1 , wherein the coupler mechanism is adapted to be moved outside the lumen by extending the elongate member distally while holding the elongate sheath proximally.

4. The medical device system of any one of claims 1 to 3, wherein the coupler mechanism is adapted to limit relative axial movement between the distal coupler and the proximal coupler while allowing relative radial movement when not specifically constrained by the elongated sheath.

5. 5. The medical device system of claim 1, wherein the distal coupler includes a first bearing surface and the proximal coupler includes a second bearing surface, the first bearing surface engaging the second bearing surface to limit relative axial movement therebetween.

6. The medical device system of any one of claims 1 to 5, wherein the coupler mechanism is adapted such that distal movement of the elongate member is transmitted to the IMD via the coupler mechanism while the IMD remains fixed to the distal coupler.

7. The medical device system of any one of claims 1 to 6, wherein the coupler mechanism is adapted such that proximal movement of the elongate member is transmitted to the IMD via the coupler mechanism while the IMD remains fixed to the distal coupler.

8. 8. The medical device system of claim 1, wherein one of the distal coupler and the proximal coupler comprises a protrusion and the other of the distal coupler and the proximal coupler comprises a recess, the recess being complementary to the protrusion such that the protrusion fits within the recess.

9. The medical device system of claim 8 , wherein the protrusion is adapted to slide radially into the recess that is complementary to the protrusion.

10. 10. The medical device system of claim 8 or 9, wherein the protrusions comprise one of trapezoidal protrusions, straight protrusions, frustoconical protrusions, or bulbous protrusions.

11. 1. A system for delivering embolic coils, comprising: an elongate sheath defining a lumen extending therethrough; an elongate member extending through the lumen; a coupler mechanism slidably disposed within the lumen to releasably couple an embolic coil to the elongate member; the coupler mechanism is adapted to prevent the embolic coil from separating from the elongate member while the coupler mechanism is radially constrained by the elongate sheath; The system, wherein the coupler mechanism is adapted to allow the embolic coil to detach from the elongate member when the coupler mechanism is no longer radially constrained by the elongate sheath.

12. The coupler mechanism includes: a first coupler segment secured to the elongate member; A second coupler segment secured to the embolic coil.

13. 13. The system of claim 12, wherein the first coupler segment is adapted to engage the second coupler segment and limit relative axial movement therebetween when the coupler mechanism is radially constrained by the elongate sheath.

14. 13. The system of claim 12, wherein the first coupler segment is adapted to disengage from the second coupler segment when the coupler mechanism is not radially constrained by the elongate sheath, thereby releasing the embolic coil from the elongate member.

15. 1. An embolic therapy system comprising: an elongate sheath defining a lumen extending therethrough; a coupler mechanism slidably disposed within the lumen, the coupler mechanism including a proximal coupler and a distal coupler; an elongate member secured to the proximal coupler and extending proximally from the proximal coupler; an embolic coil secured to 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 disengaged from the proximal coupler when the coupler mechanism is outside the lumen, thereby releasing the embolic coil and the proximal coupler.

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