Medical device release system

Abstract

A medical device system includes an elongate sheath defining a lumen extending within the elongate sheath. A coupler mechanism is slidably disposed within the lumen, the coupler mechanism including 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 when the coupler mechanism is retained within the lumen; and when the coupler mechanism is external to the lumen, the distal coupler is released from the proximal coupler, thereby releasing the IMD.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 355,857, filed on June 27, 2022, the entire disclosure of which is hereby incorporated by reference herein. Technical Field

[0003] The present disclosure relates to medical devices and methods of making and / or utilizing medical devices. More particularly, the present disclosure relates to configurations of systems for releasing medical implants. Background Art

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

[0005] The present disclosure relates to configurations of systems for releasing medical implants. Examples can be found in medical device systems. The medical device system includes an elongated sheath that defines a lumen extending within the elongated sheath. A connector mechanism is slidably disposed within the lumen, the connector mechanism including a proximal connector and a distal connector. An elongated member is secured to the proximal connector and extends proximally therefrom. An implantable medical device (IMD) is secured to the distal connector and extends distally therefrom. When the connector mechanism is retained within the lumen, the distal connector remains secured to the proximal connector; and when the connector mechanism is outside the lumen, the distal connector is released from the proximal connector, thereby releasing the IMD.

[0006] Alternatively or additionally, the coupler mechanism may be adapted to be moved outside the lumen by withdrawing the elongate sheath proximally while maintaining the elongate member stationary.

[0007] Alternatively or additionally, the coupler mechanism may be adapted to move outside of the lumen by extending the elongate member distally while maintaining the elongate sheath proximally.

[0008] Alternatively or additionally, the coupler mechanism may be adapted to limit relative axial movement between the distal coupler and the proximal coupler, while allowing relative radial movement when not constrained by the elongate sheath.

[0009] Alternatively or additionally, the distal coupler may include a first bearing surface and the proximal coupler may include a second bearing surface, wherein the first bearing surface engages the second bearing surface to limit relative axial movement therebetween.

[0010] Alternatively or additionally, 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 secured to the distal coupler.

[0011] Alternatively or additionally, 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 secured to the distal coupler.

[0012] Alternatively or additionally, the IMD may include an embolic coil.

[0013] 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 that is complementary to the protrusion, such that the protrusion fits within the recess.

[0014] Alternatively or additionally, the projection may be adapted to slide radially into a recess complementary to the projection.

[0015] Alternatively or additionally, the protrusion may comprise a trapezoidal protrusion.

[0016] Alternatively or additionally, the protrusion may comprise a linear protrusion.

[0017] Alternatively or additionally, the protrusion may comprise a frusto-conical protrusion.

[0018] Alternatively or additionally, the protrusion may comprise a bulbous protrusion.

[0019] Another example can be found in a system for delivering an embolic coil. The system includes an elongated sheath defining a lumen, an elongated member extending through the lumen, and a coupling mechanism slidably disposed within the lumen and releasably coupling the embolic coil to the elongated member; the lumen extends within the elongated sheath. The coupling mechanism is adapted to prevent the embolic coil from being separated from the elongated member when the coupling mechanism is radially constrained by the elongated sheath; and to allow the embolic coil to be separated from the elongated member when the coupling mechanism is no longer radially constrained by the elongated sheath.

[0020] Alternatively or additionally, the coupler mechanism may include a first coupler section secured to the elongate member and a second coupler section secured to the embolic coil.

[0021] Alternatively or additionally, the first coupling section may be adapted to engage the second coupling section and restrict relative axial movement therebetween when the coupling mechanism is radially constrained by the elongate sheath.

[0022] Alternatively or additionally, the first coupler section may be adapted to disengage from the second coupler section when the coupler mechanism is not radially constrained by the elongate sheath, thereby releasing the embolic coil from the elongate member.

[0023] Alternatively or additionally, the second coupler section may remain secured to the embolic coil once the embolic coil has been released from the elongate member.

[0024] Another example can be seen in an embolization therapy system. The embolization therapy system includes an elongated sheath defining a lumen, a coupler mechanism slidably disposed within the lumen and including a proximal coupler and a distal coupler, an elongated member fixed to and extending proximally from the proximal coupler, and an embolic coil fixed to and extending distally from the distal coupler; the lumen extends within the elongated sheath. When the coupler mechanism remains within the lumen, the distal coupler remains fixed to the proximal coupler; and when the coupler mechanism is outside the lumen, the distal coupler is released from the proximal coupler, thereby releasing the embolic coil and the proximal coupler.

[0025] 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

[0026] The present invention may be more fully understood by considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0027] Figure 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;

[0028] Figure 2 for Figure 1 Schematic side view of an exemplary delivery device showing an IMD being ejected from the delivery device;

[0029] Figure 3 for Figure 1 Schematic side view of an exemplary delivery device in FIG. 1 , showing the IMD detached from the delivery device;

[0030] Figure 4A is a perspective view of an exemplary coupling mechanism that can be used to releasably secure an IMD to a Figure 1 delivery device;

[0031] Figure 4B for Figure 4A A perspective view of an exemplary coupling mechanism in which two coupling sections are separated from each other;

[0032] Figure 4C is a perspective view of a first coupling section, which forms Figure 4A A portion of an exemplary coupling mechanism;

[0033] Figure 4Dis a perspective view of the second coupling section, which forms Figure 4A A portion of an exemplary coupling mechanism;

[0034] Figure 5A is a side view of an exemplary coupling mechanism that can be used to releasably secure an IMD to a Figure 1 delivery device;

[0035] Figure 5B for Figure 5A A side view of an exemplary coupling mechanism in which two coupling sections are separated from each other;

[0036] Fig. 6A is a perspective view of an exemplary coupling mechanism that can be used to releasably secure an IMD to a Figure 1 delivery device;

[0037] Figure 6B for Fig. 6A A perspective view of an exemplary coupling mechanism in which two coupling sections are separated from each other;

[0038] Fig. 7A is a perspective view of an exemplary coupling mechanism that can be used to releasably secure an IMD to a Figure 1 a delivery device; and

[0039] Figure 7B for Fig. 7A A perspective view of an exemplary coupling mechanism in which the two coupling sections are separated from each other.

[0040] Although aspects of the present disclosure may be modified into various modifications and alternatives, the details have been shown in the drawings by way of example and will be described in detail. However, it should be understood that it is not intended to limit aspects of the present disclosure to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternative forms that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0041] The following description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, wherein like reference numerals indicate similar elements in several views. The detailed description and the accompanying drawings are intended to illustrate but not limit the claimed invention. 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 the present disclosure. The detailed description and the accompanying drawings illustrate example embodiments of the claimed invention.

[0042] With respect to the following defined terms, these definitions shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0043] All numerical values ​​are assumed herein to be modified by the term "about", whether or not explicitly indicated. In the context of numerical values, the term "about" generally refers to a numerical range that one skilled in the art would consider equivalent to the stated value (e.g., having the same function or result). In many cases, the term "about" may include numbers 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 ordinary and customary definitions, as understood and consistent with the context of the specification, unless otherwise indicated.

[0044] The recitation of numerical ranges by endpoints includes all numbers within that range, inclusive of the endpoints (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0045] Although some suitable sizes, ranges and / or values ​​are disclosed in relation to various components, features and / or specifications, those skilled in the art, in light of this disclosure, will appreciate that the desired sizes, ranges and / or values ​​may deviate from those explicitly disclosed.

[0046] As used in this specification and the appended claims, the singular forms "one", "a kind of" and "the" include plural referents unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or", unless the context clearly indicates otherwise. It should be noted that, for ease of understanding, certain features of the present disclosure may be described in singular form, even if these features may be plural or repeated within the disclosed embodiments. Each of these features may include singular disclosures and / or may be composed thereof, unless explicitly stated to the contrary. For simplicity and clarity purposes, not all elements of the disclosed invention are shown in each figure or discussed in detail below. However, it will be understood that the following discussion may be equally applicable to any one and / or all of more than one component, unless explicitly stated to the contrary. In addition, for clarity, not all cases of some elements or features are shown in each figure.

[0047] Relative terms, such as "proximal", "distal", "advance", "retraction", variations thereof, and the like, may generally be considered with respect to the positioning, orientation, and / or operation of various elements relative to a user / operator / manipulator of the device, with "proximal" and "retraction" indicating or referring to being closer to or toward the user, and "distal" and "advance" indicating or referring to being farther away from or away from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily designated to facilitate understanding of the present disclosure, and such cases will be apparent to those skilled in the art. Other relative terms (such as "upstream", "downstream", "inflow", and "outflow") refer to the direction of flow of a fluid in a lumen, such as a body lumen, a blood vessel, or within a device.

[0048] The term "range" may be understood to mean the maximum measurement of a stated or identified dimension. For example, "external range" may be understood to mean the maximum external dimension, "radial range" may be understood to mean the maximum radial dimension, "longitudinal range" may be understood to mean the maximum longitudinal dimension, and so on. Each instance of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be apparent to the skilled person from the context of individual use. In general, "range" may be considered to be the maximum possible dimension measured for the intended use. In some cases, "range" may be measured orthogonally, typically in a plane and / or cross-section; but may be measured in different ways, such as, but not limited to, angles, radials, circumferentials (e.g., along an arc), and the like, as is apparent from the particular context.

[0049] It should be noted that when the specification refers to "one embodiment", "some embodiments", "other embodiments", etc., it means that the described embodiments may include specific features, structures or characteristics, but not necessarily every embodiment includes the specific features, structures or characteristics. In addition, such phrases do not necessarily refer to the same embodiment. In addition, when a specific feature, structure or characteristic is described in conjunction with one embodiment, those skilled in the art will know that the effect of combining with other embodiments to produce the specific feature, structure or characteristic, whether or not explicitly described, unless clearly stated to the contrary. That is, the various individual elements described below, even if not explicitly shown in a specific combination, are conceived to be combined or arranged with each other to form other additional embodiments or to supplement and / or enrich the described embodiments, as understood by those of ordinary skill in the art.

[0050] For the purpose of clarity, certain identification number nomenclatures (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish various described and / or claimed features. It should be understood that the numerical designations are not intended to be restrictive, but are merely exemplary. In some embodiments, for simplicity and clarity, changes and deviations may be made to the previously used numerical designations. That is, the feature identified as a "first" element may be subsequently referred to as a "second" element, a "third" element, etc., or may be ignored as a whole, and / or different features may be referred to as a "first" element. In each case, the meaning and / or title will be apparent to those skilled in the art.

[0051] Various implantable medical devices (IMDs) may be delivered to a delivery site within a patient's body via an intravascular delivery pathway. Figures 1 to 3 Exemplary techniques for delivering an IMD are provided. In some cases, the IMD may be an embolic coil, but the disclosure is not limited to embolic coils, as any of a variety of different IMDs may be delivered in the manner described herein. Figure 11 is a schematic diagram of a medical device system 10, which includes an elongated sheath 12 defining a lumen 14, the lumen 14 extending through the elongated sheath 12. The elongated sheath 12 can be a single-layer polymer sheath, a double-layer polymer sheath, or a multi-layer polymer sheath. The elongated sheath 12 can include a reinforcement structure, such as a braid or a coil, for example. In some cases, although not shown, the elongated sheath 12 can include one or more radiopaque markers that are visible, for example, under fluoroscopic conditions.

[0052] Several internal components are schematically shown in dashed lines. The coupling mechanism 16 is slidably disposed within the lumen 14. In some cases, as shown, the coupling mechanism 16 includes a proximal coupling 18 and a distal coupling 20. The proximal coupling 18 can be fixed to the elongated member 22, which can be manipulated, for example, at the proximal end (not shown) of the medical device system 10 to cause the elongated member 22 and thus the coupling mechanism 16 to move axially within the lumen 14. In some cases, the proximal coupling 18 can be fixed to the elongated member 22 by laser welding, brazing, swaging, crimping, or bonding the proximal end of the proximal coupling 18 to the elongated member 22. The distal coupling 20 can be fixed to the IMD 24, and in some cases, remains fixed to the IMD 24 even after the IMD 24 has been deployed.

[0053] 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 raw material used to prepare 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 manufacturing and subtractive manufacturing may be used to prepare 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.

[0054] In some cases, the coupling mechanism 16 can be designed so that the proximal coupling 18 and the distal coupling 20 remain fixed together until it is desired to release the IMD 24. For example, the proximal coupling 18 and the distal coupling 20 can be adapted to engage with each other in a manner that allows the coupling mechanism 16 to move axially within the lumen 14 (as long as the coupling mechanism 16 remains within the lumen 14). Once the coupling mechanism 16 or at least a portion thereof is moved to a position outside of the lumen 14, the proximal coupling 18 and the distal coupling 20 can be disengaged from each other. In some cases, the proximal coupling 18 and the distal coupling 20 are adapted to remain engaged together when the proximal coupling 18 and the distal coupling 20 are constrained from relative radial movement (including being radially constrained by the elongated sheath 12).

[0055] The coupler mechanism 16 can be adapted such that when the coupler mechanism 16 is retained within the lumen 14, axial movement of the elongated member 22 is transmitted to the IMD 24 via the coupler mechanism 16. For example, pushing the elongated member 22 in a distal direction relative to the elongated sheath 12 can cause the IMD 24 to move distally. Pulling the elongated member 22 in a proximal direction relative to the elongated sheath 12 can cause the IMD 24 to move proximally. Pulling the elongated sheath 12 proximally while holding the elongated member 22 stationary can cause the distal end 26 of the elongated sheath 12 to move closer to the IMD 24. Pushing the elongated sheath 12 distally while holding the elongated member 22 stationary can cause the distal end 26 of the elongated sheath 12 to move further away from the IMD 24.

[0056] Figure 1 Coupler mechanism 16 and IMD 24 are shown fully within lumen 14 . Figure 2 and Figure 3 FIG. 2 shows the deployment of IMD 24. Figure 2 , the elongated member 22 is advanced distally relative to the elongated sheath 12 (or the elongated sheath 12 is withdrawn proximally relative to the elongated member 22). Therefore, the coupling mechanism 16 and the IMD 24 are outside the lumen 14, while the elongated member 22 extends proximally within the lumen 14. At this point, the coupling mechanism 16 is no longer radially constrained by the elongated sheath 12. This means that the proximal coupling 18 and the distal coupling 20 are free to move radially relative to each other. As an example, the proximal coupling 18 may be free to move in a first radial direction indicated by arrow 28, and / or the distal coupling 20 may be free to move in a second radial direction indicated by arrow 30; similarly, the proximal coupling 18 may be free to move in a second radial direction indicated by arrow 30, while the distal coupling 20 may be free to move in a first radial direction indicated by arrow 28. In some cases, the proximal coupling 18 and / or the distal coupling 20 may be free to move in different radial directions not shown by arrows 28 and 30.

[0057] Move to Figure 3 , it can be seen that distal coupler 20 has been disengaged from proximal coupler 18, but distal coupler 20 remains fixed to IMD 24. In some cases, distal coupler 20 can now be considered part of IMD 24. At this point, elongated member 22 can be withdrawn proximally into lumen 14 by pulling elongated member 22 proximally relative to elongated sheath 12 or pushing elongated sheath 12 distally while keeping elongated member 22 stationary. Next, elongated sheath 12 (together with elongated member 22 and proximal coupler 18) can be withdrawn from the deployment site and withdrawn from the patient. In some cases, lumen 14 can alternatively be used to deliver another IMD.

[0058] Figure 4A is a perspective view of an exemplary coupling mechanism 100, and Figure 4B 1 is an exploded perspective view of an exemplary coupling mechanism 100. The exemplary coupling mechanism 100 can be considered as an example of the coupling mechanism 16. The coupling mechanism 100 includes a first coupling section 102 and a second coupling section 104. In some cases, the first coupling section 102 can be an example of the proximal coupling 18, and the second coupling section 104 can be an example of the distal coupling 20. IMD24 ( Figure 4A or Figure 4B The first connector section 102 and the second connector section 104 may be regarded as being suitable for fixing to any one of the first connector section 102 and the second connector section 104 as the distal connector 20. The other of the first connector section 102 and the second connector section 104 may be regarded as being suitable for fixing to the elongated member 22 ( Figure 4A or Figure 4B not shown).

[0059] The first coupling section 102 includes a protrusion 106 adapted to fit within a corresponding recess 108 formed in the second coupling section 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, and the recess 108 includes bearing surfaces 108a and 108b. It should be understood that if any force is applied to the coupling mechanism 100 causing the first coupling section 102 to move axially away from the second coupling section 104, the first bearing surfaces 106a and 106b will engage the bearing surfaces 108a and 108b to prevent the relative axial movement.

[0060] It should be understood that although the figures show sharp corners and edges; in some cases, the corners and edges may be rounded due to manufacturing tolerances and to make the components easier to move relative to each other. For example, to make it easier for the protrusion 106 to fit into the corresponding recess 108 and eventually move radially out of the corresponding recess 108. Although some features are shown parallel to other features, in some cases, the first coupling section 102 and the second coupling section 104 may not be formed exactly as shown, but may have additional manufacturing tolerances.

[0061] Figure 4C and Figure 4D 1 and 10. A perspective view of the first coupling section 102 and the second coupling section 104, respectively, indicating some dimensions of the protrusion 106 and the recess 108. Figure 4CAs shown, the protrusion 106 has a minimum width W1 and a maximum width W2. The protrusion 106 has a depth or thickness D1 and a length L1. In some cases, W1 can be in the range of 0.005 inches to 0.010 inches. In some cases, W2 can be in the range of 0.015 inches to 0.025 inches. D1 can be in the range of 0.007 inches to 0.0175 inches. L1 can be in the range of 0.010 inches to 0.020 inches. In one example, W1 is 0.009 inches, W2 is 0.019 inches, D1 is 0.0175 inches, and L1 is 0.015 inches.

[0062] like Figure 4D As shown, the recessed portion 108 may have a size slightly larger than each corresponding size of the protrusion 106 to allow the protrusion 106 to easily fit into the recessed portion 108 to keep the first coupling section 102 and the second coupling section 104 together while allowing easy separation when separation is required. The recessed portion 108 has a minimum width W3 and a maximum width W4. The recessed portion 108 has a depth D2 and a length L2. In some cases, W3 may be in the range of 0.007 inches to 0.013 inches. In some cases, W4 may be in the range of 0.020 inches to 0.028 inches. D2 may be in the range of 0.007 inches to 0.0175 inches. L2 may be in the range of 0.012 inches to 0.022 inches. In one example, W3 is 0.012 inches, W4 is 0.022 inches, D2 is 0.0175 inches, and L2 is 0.016 inches. These dimensions may be selected to ensure that there is sufficient interaction between the protrusion 106 and the recess 108 to ensure that the protrusion 106 is retained within the recess 108 until separation is desired.

[0063] In some cases, the first coupling section 102 and the second coupling section 104 may have a maximum diameter of 0.033 inches, and the length of each of the first coupling section 102 and the second coupling section 104 is 0.030 inches. It should 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 ten percent of the maximum diameter, or twenty percent of the maximum diameter, or three percent, or forty percent. D2 may be ten percent of the maximum diameter, or twenty percent of the maximum diameter, or thirty percent, or forty percent; wherein D2 is at least slightly larger than D1.

[0064] Thus, the protrusion 106 and the recess 108 are adapted so that they can be radially moved apart only in a specific direction. To separate, the first coupling section 102 can be moved relative to the second coupling section 104 in a direction generally away from the paper, and / or the second coupling section 104 can be moved relative to the first coupling section 102 in a direction generally into the paper to disengage the protrusion 106 from the recess 108.

[0065] Figure 5A is a side view of an exemplary coupling mechanism 110, and Figure 5B 1 is an exploded side view of an exemplary coupling mechanism 110. The exemplary coupling mechanism 110 can be considered as an example of the coupling mechanism 16. The coupling mechanism 110 includes a first coupling section 112 and a second coupling section 114. In some cases, the first coupling section 112 can be an example of the proximal coupling 18, and the second coupling section 114 can be an example of the distal coupling 20. IMD 24 ( Figure 5A or Figure 5B The first connector section 112 and the second connector section 114 may be regarded as being adapted to be fixed to either of the first connector section 112 and the second connector section 114 as the distal connector 20. The other of the first connector section 112 and the second connector section 114 may be regarded as being adapted to be fixed to the elongated member 22 ( Figure 5A or Figure 5B not shown).

[0066] The first coupling section 112 includes a protrusion 116 adapted to fit within a corresponding recess 118 formed in the second coupling section 114. In some cases, as shown, the protrusion 116 is a linear protrusion and the corresponding recess 118 is a linear recess. In some cases, the protrusion 116 includes an annular bearing surface 116a, and the recess 118 includes an annular bearing surface 118a. It should be understood that if any force is applied to the coupling mechanism 110 so that the first coupling section 112 moves axially away from the second coupling section 114, the annular bearing surface 116a will engage the annular bearing surface 118a to prevent the relative axial movement. The protrusion 116 can be considered to include a bearing surface 116b, which engages the bearing surface 118b of the recess 118 when the first coupling section 112 moves toward the second coupling section 114, thereby providing pushability through the coupling mechanism 110. It should be appreciated that when not radially constrained, such as by the elongated sheath 12 , the first and second coupling sections 112 , 114 are free to move radially relative to one another.

[0067] In some cases, about Figure 5B, the protrusion 116 may have a diameter of 0.007 inches to 0.010 inches and a length of 0.007 inches to 0.035 inches. The bearing surface 116b may have a diameter of 0.010 inches to 0.018 inches and a length of 0.007 inches to 0.035 inches. The size of the bearing surface 116 will depend on the size of the protrusion 116 and the bearing surface 116b. The size of the annular bearing surface 118a will depend on the size of the recess 118 and the bearing surface 118b.

[0068] Fig. 6A is a perspective view of an exemplary coupling mechanism 120, and Figure 6B 1 is an exploded perspective view of an exemplary coupling mechanism 120. The exemplary coupling mechanism 120 can be considered as an example of the coupling mechanism 16. The coupling mechanism 120 includes a first coupling section 122 and a second coupling section 124. In some cases, the first coupling section 122 can be an example of the proximal coupling 18, and the second coupling section 124 can be an example of the distal coupling 20. IMD24 ( Fig. 6A or Figure 6B The first connector section 122 and the second connector section 124 may be regarded as being suitable for fixing to any one of the first connector section 122 and the second connector section 124 as the distal connector 20. The other of the first connector section 122 and the second connector section 124 may be regarded as being suitable for fixing to the elongated member 22 ( Fig. 6A or Figure 6B not shown).

[0069] The first coupling section 122 includes a protrusion 126 that is adapted to fit within a corresponding recess 128 formed in the second coupling section 124. In some cases, as shown, the protrusion 126 is a frustoconical protrusion and the corresponding recess 128 is adapted to receive the protrusion 126. In some cases, the protrusion 126 includes a tapered bearing surface 126a, and the recess 128 includes a first bearing surface 128a and a second bearing surface 128b. It should be understood that if any force is applied to the coupling mechanism 120 such that the first coupling section 122 moves axially away from the second coupling section 124, the tapered bearing surface 126a will engage the annular bearing surfaces 128a and 128b to prevent relative axial movement. The protrusion 126 can be considered to include a bearing surface 126b that engages a bearing surface 128c of the recess 128 as the first coupler section 122 moves toward the second coupler section 124, thereby providing pushability through the coupler mechanism 120. It should be understood that when not radially constrained, such as by the elongated sheath 12, the first coupler section 122 and the second coupler section 124 are free to move radially relative to each other.

[0070] Fig. 7A is a perspective view of an exemplary coupling mechanism 130, and Figure 7B1 is an exploded perspective view of an exemplary coupling mechanism 130. The exemplary coupling mechanism 130 can be considered as an example of the coupling mechanism 16. The coupling mechanism 130 includes a first coupling section 132 and a second coupling section 134. In some cases, the first coupling section 132 can be an example of the proximal coupling 18, and the second coupling section 134 can be an example of the distal coupling 20. IMD24( Fig. 7A or Figure 7B The first connector section 132 and the second connector section 134 may be regarded as being suitable for fixing to any one of the first connector section 132 and the second connector section 134 as the distal connector 20. The other of the first connector section 132 and the second connector section 134 may be regarded as being suitable for fixing to the elongated member 22 ( Fig. 7A or Figure 7B not shown).

[0071] The first coupling section 132 includes a protrusion 136 that is adapted to fit within a corresponding recess 138 formed in the second coupling section 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 should be understood that if any force is applied to the coupling mechanism 130 such that the first coupling section 132 moves axially away from the second coupling section 134, the spherical bearing surface 136a will engage the annular bearing surfaces 138a and 138b to prevent the relative axial movement. The protrusion 136 can be considered to include a bearing surface 136b that engages a bearing surface 138c of the recess 138 as the first coupler section 132 moves toward the second coupler section 134, thereby providing pushability through the coupler mechanism 130. It should be understood that the first coupler section 132 and the second coupler section 134 are free to move radially relative to each other when not radially constrained, such as by the elongated sheath 12.

[0072] Materials that can be used for the various components of the medical device systems described herein and the various elements disclosed herein may include those commonly associated with medical devices. In some embodiments, the medical device systems described herein may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steel (such as 444V, 444L, and 314LV stainless steel), mild steel, nickel-titanium alloys (such as linear elastic and / or superelastic nitinol), other nickel alloys (such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as 625; UNS:N06022, such as UNS:N10276, such as other alloys, etc.)), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten alloys or tungsten alloys, etc., cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as etc.), platinum-rich stainless steel, titanium, combinations thereof, etc., or any other suitable material.

[0073] As alluded to herein, the family of commercially available nickel titanium or Nitinol alloys is a category designated as "linear elastic" or "non-superelastic", which, while chemically similar to conventional shape memory and superelastic categories, may exhibit different 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 display a general "superelastic plateau" or "landmark region" on its stress / strain curve as superelastic Nitinol does. In contrast, in linear elastic and / or non-superelastic Nitinol, as recoverable strain increases, stress continues to increase in a generally linear or somewhat, but not necessarily completely, linear relationship until plastic deformation begins or at least is in a more linear relationship than the superelastic plateau and / or landmark region seen with superelastic Nitinol. Therefore, for the purposes of this disclosure, linear elastic and / or non-superelastic Nitinol may also be referred to as "generally" linear elastic and / or non-superelastic Nitinol.

[0074] In some cases, linear elastic and / or non-superelastic Nitinol may also be distinguished from superelastic Nitinol in that linear elastic and / or non-superelastic Nitinol may accept up to about 2% to 5% strain while remaining generally elastic (e.g., before plastic deformation), whereas superelastic Nitinol may accept up to about 8% strain before plastic deformation. These materials may be distinguished from other linear elastic materials, such as stainless steel (which may also be distinguished based on its composition), which may only accept about 0.2% to 0.44% strain before plastic deformation.

[0075] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not show detectable martensite / austenite phase transformations by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a wide temperature range. For example, in some embodiments, within a range of about -60 degrees Celsius (°C) to about 120°C, the linear elastic and / or non-superelastic nickel-titanium alloy may not have detectable martensite / austenite phase transformations by DSC and DMTA analysis. Therefore, the mechanical bending properties of such materials may generally be inert to the effects of temperature over this extremely 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, because they do not show a superelastic plateau and / or signature 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 characteristics and / or properties.

[0076] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may be nickel in the range of about 50 to about 60 weight percent, with the remainder being substantially titanium. In some embodiments, the composition is nickel in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa TechnoMaterial Co. of Kanagawa, Japan. Other suitable materials may include ULTANIUM TM (available from Neo-Metrics) and GUMMETAL TM (Available from Toyota.) In some other embodiments, superelastic alloys (eg, superelastic Nitinol) may be used to achieve the desired properties.

[0077] In at least some embodiments, part or all of the medical device systems described herein may also be doped with, made of, or otherwise include radiopaque materials. Radiopaque materials should be understood as materials that are capable of producing brighter images on a fluorescent screen or another imaging technology during a medical procedure. The brighter image helps the user determine the position of the medical device system. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer materials with radiopaque fillers, and the like. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the medical device systems described herein.

[0078] 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 of materials that do not substantially distort the image and do not create significant artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may be unsuitable because they may produce artifacts on MRI images. In some cases, the medical device system or portions thereof may also be made of materials that are imageable by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R44003, such as etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R44035, such as etc.), Nitinol, etc., and others.

[0079] In some embodiments, the medical device systems described herein may include or be made of a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available from DuPont, for example). ), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers, such as those available from DuPont ), polyamides (e.g., available from Bayer Or available from Elf Atochem ), elastic polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name Obtained), ethylene vinyl acetate copolymer (EVA), siloxane, polyethylene (PE), High density polyethylene, Low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polybutylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as, available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the mixture may contain up to 6% LCP.

[0080] In some embodiments, the medical device system described herein and / or other elements disclosed herein may include a fabric material disposed on or within the structure. The fabric material may be composed of a biocompatible material, such as a polymer material or a biomaterial, which is suitable for facilitating tissue ingrowth. In some embodiments, the fabric material may include a bioabsorbable material. Some examples of suitable fabric materials include, but are not limited to, polyethylene glycol (PEG), nylon, polytetrafluoroethylene (PTFE, ePTFE), polyolefin materials (such as polyethylene, polypropylene, polyester, polyurethane), and / or blends or combinations thereof.

[0081] It should be understood that the present disclosure is in many respects illustrative only. Changes may be made in detail without exceeding the scope of the present invention, particularly with respect to the steps of shape, size and steps. To the extent appropriate, this may include the use of any of the features of an example embodiment being used in other embodiments. Of course, the scope of the present invention is defined in the language of the appended claims.

Claims

1. A medical device system, comprising: an elongated sheath defining a lumen extending within the elongated sheath; a coupler mechanism slidably disposed within the lumen, the coupler mechanism comprising a proximal coupler and a distal coupler; an elongated member secured to the proximal coupler and extending proximally therefrom; an implantable medical device (IMD) secured to and extending distally from the distal coupler; wherein the distal coupler remains secured to the proximal coupler when the coupler mechanism remains within the lumen; and Wherein when the coupler mechanism is outside of the lumen, the distal coupler is released from the proximal coupler, thereby releasing the IMD.

2. The medical device system of claim 1, wherein the coupler mechanism is adapted to be moved outside of the lumen by withdrawing the elongated sheath proximally while maintaining the elongated member stationary.

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

5. The medical device system of any one of claims 1 to 4, wherein the distal connector includes a first bearing surface and the proximal connector includes a second bearing surface, wherein the first bearing surface engages 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 connector mechanism is adapted such that distal movement of the elongated member is transmitted to the IMD via the connector mechanism while the IMD remains secured to the distal connector.

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

8. A medical device system according to any one of claims 1 to 7, wherein one of the distal connector and the proximal connector includes a protrusion, and the other of the distal connector and the proximal connector includes a recess complementary to the protrusion, so that the protrusion fits into 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. The medical device system of claim 8 or 9, wherein the protrusion comprises one of a trapezoidal protrusion, a linear protrusion, a frustoconical protrusion, or a bulbous protrusion.

11. A system for delivering an embolic coil, the system comprising: an elongated sheath defining a lumen extending within the elongated sheath; an elongated member extending through the lumen; and a coupler mechanism slidably disposed within the lumen and releasably coupling the embolic coil to the elongated member; the coupler mechanism being adapted to prevent separation of the embolic coil from the elongated member when the coupler mechanism is radially constrained by the elongated sheath; The coupling mechanism is adapted to allow the embolic coil to be separated from the elongate member when the coupling mechanism is no longer radially constrained by the elongate sheath.

12. The system of claim 11, wherein the coupler mechanism comprises: a first coupler section secured to the elongated member; and A second coupler section is secured to the embolic coil.

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

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

15. An embolization therapy system, comprising: an elongated sheath defining a lumen extending within the elongated sheath; a coupler mechanism slidably disposed within the lumen, the coupler mechanism comprising a proximal coupler and a distal coupler; an elongated member secured to the proximal coupler and extending proximally therefrom; an embolic coil secured to the distal coupler and extending distally therefrom; wherein the distal coupler remains secured to the proximal coupler when the coupler mechanism remains within the lumen; and Wherein when the coupler mechanism is outside the lumen, the distal coupler is released from the proximal coupler, thereby releasing the embolic coil and the proximal coupler.

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