Implant delivery device

Abstract

A delivery device may include a support structure for providing desired stiffness, elasticity, and kink resistance. The delivery device may include a core wire and / or one or more electrical wires electrically connected to the disconnect mechanism. A medical device, such as an implant, may be attached to the delivery device by a disengagement mechanism. The support structure may extend along or around the core wire to provide support for the delivery device, particularly when pushing larger implants through smaller catheters. The support structure may include a support wire along the core wire, a hypotube around the core wire, a braided braid around the core wire, and / or a coil wound around the core wire. The core wires may each be comprised of a non-memory shape material such as stainless steel, and the support structure may be comprised of a memory shape material such as nitinol.

Description

[0001] Related Applications

[0002] This application claims the benefit of and priority to U.S. Provisional Application Serial No. 63 / 369,344, filed on July 25, 2022, entitled “Implant Delivery Device,” the entire contents of which are incorporated herein by reference. Background Art

[0003] Various types of implant delivery systems have been used to deliver implants or similar devices to a target location in the body. Some of these delivery systems utilize an elongated push rod to advance the implant to the target location through a catheter or outer sheath. Some push rods may also include a separation mechanism that is used to separate the implant when the implant reaches its intended target location. Example implants include stents, embolic coils, and vascular plugs.

[0004] It is desirable that the push rod be relatively flexible, resistant to kinking, and provide good "pushability" for advancing the implant. These features can help the push rod and implant navigate particularly tortuous areas of the blood vessel while also preventing kinking damage to the push rod, which may lead to surgical complications. However, it can be challenging to simultaneously achieve high flexibility, high kink resistance, and good pushability because some materials are more susceptible to kinking as flexibility increases. Therefore, there is always a need for some push rod design that increases flexibility and kink resistance without sacrificing pushability. Summary of the invention

[0005] The present invention relates to a delivery system for delivering a medical device to a target location in a patient's body. For example, exemplary embodiments of the present invention can be used to deliver, position, and deploy implantable devices such as coils, stents, shunts, valves, filters, vascular plugs, stent / thrombectomy devices, etc., within body cavities, including but not limited to blood vessels, fallopian tubes, malformations such as fistulas or aneurysms, cardiac defects, and other luminal organs.

[0006] Some embodiments of the present invention relate to an elongated push rod including a non-shape memory structural component and a shape memory structural component extending longitudinally along at least a portion of the push rod to provide desired flexibility, kink resistance, and pushability. The structural component may include one or more core wires, one or more structural wires, or one or more tubular structures (e.g., solid structure, braided structure, coil structure).

[0007] An example embodiment of a delivery system may include a core guidewire composed of a non-shape memory material, such as stainless steel, and a support structure extending between a proximal region and a distal region of a pushrod. The support structure may include a shape memory material, such as Nitinol.

[0008] The delivery system may also include one or more electrical leads for powering a detachment mechanism, such as, but not limited to, a heating coil.

[0009] In one example embodiment, the support structure may extend along the core conductor, such as parallel to the core conductor.

[0010] In one example embodiment, the support structure may at least partially surround the support structure.

[0011] In one example embodiment, the support structure may include a hypotube. The hypotube may at least partially surround one or more electrical conductors connected to a decoupling mechanism, such as located at a distal end or distal region of the pushrod.

[0012] In one example embodiment, the support structure may include a support wire. At least a portion of the support wire may be tapered. In some embodiments, at least a portion of the core wire may also be tapered.

[0013] In one example embodiment, the core wire may be composed of stainless steel and the support wire may be composed of Nitinol.

[0014] In one example embodiment, the support structure may include a braid. The braid may at least partially surround one or more electrical conductors connected to a decoupling mechanism at or near the distal end of the push rod.

[0015] In one example embodiment, the support structure may include a coil. The coil may be wound around part or all of the length of the core conductor.

[0016] In another example embodiment, the present invention may include a core wire composed of a non-shape memory material, a detachment mechanism for detaching an implant, a pair of electrical wires connected to the detachment mechanism, and a support structure composed of a shape memory material extending between a proximal region and a distal region of the push rod.

[0017] In one example embodiment, the support structure may extend parallel to the core conductor and the pair of electrical conductors and at least partially surround the core conductor and the pair of electrical conductors.

[0018] In another example embodiment, the present invention may include a push rod for delivering a medical device through a lumen, the push rod including a rigidity device composed of a non-shape memory material for providing rigidity to the push rod, and an anti-kink device for supporting the rigidity device. The anti-kink device may extend between a proximal region and a distal region of the push rod and may include a shape memory material. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] These and other aspects, features and advantages that can be achieved by embodiments of the present invention will become apparent from the following description of embodiments of the present invention with reference to the accompanying drawings, which are not drawn to scale, in which:

[0020] Figure 1A is an isometric view of an implant delivery device according to an example embodiment.

[0021] Figure 1B is a side view of an implant delivery device according to an example embodiment.

[0022] Figure 2A is an isometric view of an implant delivery device according to an example embodiment.

[0023] Figure 2B is a side view of an implant delivery device according to an example embodiment.

[0024] Figure 3A is an isometric view of an implant delivery device according to an example embodiment.

[0025] Figure 3B is a side view of an implant delivery device according to an example embodiment.

[0026] Figure 4A is an isometric view of an implant delivery device according to an example embodiment.

[0027] Figure 4B is a side view of an implant delivery device according to an example embodiment.

[0028] Figure 5A is an isometric view of an implant delivery device according to an example embodiment.

[0029] Figure 5B is a side view of an implant delivery device according to an example embodiment.

[0030] Figure 6 is a side view of an implant delivery device and implant according to an example embodiment.

[0031] Figure 7 is a side view of an implant delivery device and implant according to an example embodiment.

[0032] Figure 8 is a side view of an implant delivery device and implant according to an example embodiment.

[0033] Fig. 9 is a side view of an implant delivery device and implant according to an example embodiment. DETAILED DESCRIPTION

[0034] Specific embodiments of the present invention will now be described with reference to the accompanying drawings. However, the present invention can be embodied in many different forms and should not be construed as limited to the embodiments described herein; rather, these embodiments are provided to make the present disclosure thorough and complete and to fully convey the scope of the present invention to those skilled in the art. The terms used in the detailed description of the embodiments shown in the accompanying drawings are not intended to limit the present invention. In the accompanying drawings, the same numbers represent the same elements.

[0035] Delivery devices such as push rods and their external delivery catheters or sheaths are often used to advance deliverable medical devices (such as implants) to a target location in a patient's body. The delivery device is often advanced through the lumen of a guide device such as a catheter to deliver the medical device. When transporting such medical devices, it is often necessary to pass through tortuous paths, such as sharp turns. Therefore, the delivery devices often require the necessary flexibility when advancing through the lumen of the external guide device so that they do not cause damage to the patient's blood vessels. However, the push rod of the delivery device must also have sufficient "pushability" or strength to allow the distal end to advance through its external delivery catheter / sheath without kinking. The risk of such kinking or other undesirable conditions may increase with increased flexibility and / or when a larger medical device is advanced through a smaller external guide device.

[0036] The present invention generally relates to a delivery device that can be used in conjunction with any known medical procedure in which a medical device is delivered through a guide device, such as an implant delivered through a catheter. In one example, the delivery device includes an elongated delivery catheter, an elongated push rod located within the delivery catheter, and an implant located within a distal region of the delivery catheter. The push rod can be in contact with the implant and / or releasably attached to the implant so that the physician can push the implant distally out of the delivery catheter and disconnect the implant from the distal end of the push rod. In this example, the entire delivery device can be advanced through a larger guide catheter previously placed in the patient's body. In another example, the delivery device can be advanced over a previously placed guide wire. Therefore, although the project delivery device discussed in this specification focuses on the push rod and implant, components such as an external delivery catheter or delivery sheath may also be considered part of the delivery device.

[0037] The delivery device of the present invention may include an elongated push rod including a non-shape memory structural component and a shape memory structural component that extend longitudinally along at least a portion of the push rod to provide desired flexibility, kink resistance, and pushability. The structural component may include one or more core wires, one or more structural wires, or one or more tubular structures (e.g., solid structure, braided structure, coil structure).

[0038] For example, the push rod may include a core wire and a support structure to reduce the likelihood of kinking and provide a desired stiffness profile for the delivery device. The core wire may be composed of a non-shape memory material, and the support structure may be composed of a shape memory material. The non-shape memory material may be stainless steel, and the shape memory material may be nitinol.

[0039] The delivery device of the present invention can be configured to deliver a medical device (such as an implant) to a target location in a patient's body. The medical device can be detachably attached to the distal end of the delivery device by a separation mechanism, and when the delivery device delivers the medical device to the target location, the separation mechanism is activated to release the medical device. One or more electrical conductors can be connected between a power source (such as in the proximal region or vicinity of the delivery device) and the separation mechanism for providing current to the separation mechanism (such as a heating coil). A filament such as a monofilament (such as a polymer monofilament) can extend through the heating coil as a part of the separation mechanism, and when current is applied to the heating coil to heat the separation mechanism, the monofilament can melt and separate the medical device from the delivery device.

[0040] The support structure may extend between the proximal region and the distal region of the delivery device. The support structure may extend along the core conductor in a parallel orientation relative to the core conductor and / or the one or more electrical conductors. The support structure may alternatively or additionally partially or completely surround the core conductor and / or the one or more electrical conductors. The support structure may be equal to, greater than, or less than the length of the core conductor and / or the one or more electrical conductors.

[0041] The support structure may include one or more of a support wire, a hypotube, a braid, and / or a coil. One or more portions of the support wire may be tapered to match a corresponding taper of the core wire. The support wire may extend parallel to the core wire and / or one or more electrical conductors. The support wire may be connected to the core wire and / or one or more electrical conductors by welding or soldering. The hypotube, braid, or coil may surround the core wire and / or one or more electrical conductors. The support structure may be partially or completely encapsulated in an outer sheath, such as a polymer sheath.

[0042] Specific example embodiments are further described below. However, it should be understood that any features from any embodiment can be combined and matched with each other in any combination. Therefore, the present invention should not be limited to these embodiments, but any wider combination thereof.

[0043] The drawings illustrate example embodiments of a delivery device 100 of a delivery system for delivering a medical device such as an implant 105. The type of delivery device 100 may vary in different embodiments and should therefore not be construed as being limited to the example embodiments shown in the drawings. In one example embodiment, the delivery device 100 may include a push rod configured to push a medical device such as an implant 105 from an external delivery catheter 115 to a target location within the body (e.g., within a blood vessel of the body).

[0044] The delivery device 100 may include a proximal region having a proximal tip and a distal region having a distal tip. The proximal region may be defined as including half of the length of the delivery device 100 from its proximal tip toward its distal tip. The distal region may be defined as including half of the length of the delivery device 100 from its distal tip toward its proximal tip. The proximal region of the delivery device 100 may include a handle that is integrally or detachably attached to the proximal region, which an operator may grasp and manipulate when advancing or retracting the delivery device 100.

[0045] It should be understood that in different embodiments, the type of implant 105 delivered by the delivery device 100 can vary. Non-limiting examples of such implants 105 include embolic devices, stents, and vascular plugs for occluding blood vessels. The present invention should not be construed as limited to use with any particular type of medical device, and should therefore be interpreted as covering any type of medical device that can be delivered to a target location in the body for a wide range of medical purposes, including diagnosis and treatment.

[0046] The delivery device 100 may include two or more structural components, one of which may include a core wire 101 extending along all or part of its length, such as between a proximal region and a distal region of the delivery device 100. The core wire 101 may be included to provide a desired stiffness to the delivery device 100 so that the delivery device 100 is more likely to pass through tortuous vasculature without failing due to, for example, kinking. The length of the core wire 101 may vary in different embodiments and may be equal to, greater than, or less than the length of the delivery device 100.

[0047] In different embodiments, the diameter or width of the core wire 101 may also vary. Therefore, the ratio of the diameter to the width of the core wire 101 to the overall diameter or overall width of the delivery device 100 may vary and should not be construed as being limited to the example embodiments shown in the accompanying drawings. Figure 2A-2BIn some example embodiments shown, at least a portion of the core conductor 101 may be tapered such that the core conductor 101 decreases in diameter along at least a portion of its length. The rate and degree of the taper, such as the maximum diameter or width, the minimum diameter or width, and the length of the taper, may vary in different embodiments.

[0048] In different embodiments, the positioning of the core conductor 101 can also vary. In some embodiments, the core conductor 101 can be centrally located within the delivery device 100 (e.g., located along the central longitudinal axis of the delivery device 100). In other embodiments, the core conductor 101 can be offset from the central longitudinal axis of the delivery device 100.

[0049] In different embodiments, the type of material used for the core wire 101 may also vary. In one example embodiment, the core wire 101 may be composed of a non-shape memory material, such as, but not limited to, various metals or metal alloys. As a non-limiting example, in an example embodiment, the core wire 101 may be composed of stainless steel.

[0050] As shown, one or more electrical conductors 102A, 102B can extend through the delivery device 100. The proximal end of each electrical conductor 102A, 102B can be located at or near a proximal region of the delivery device 100, such as at or near a proximal tip. However, in some embodiments, the proximal end of each electrical conductor 102A, 102B can be located at various other locations, including outside of the delivery device 100. In some embodiments, the electrical conductors 102A, 102B can be longer than the delivery device 100. In other embodiments, the electrical conductors 102A, 102B can be the same length as the delivery device 100 or shorter than the delivery device 100.

[0051] Typically, the electrical conductors 102A, 102B can be electrically connected to a power source. Thus, the electrical conductors 102A, 102B can be used to power the separation device 100 (e.g., by conducting an electric current thereto), as described below. The power source can be integrated with the delivery device 100 or can be separately connected to the delivery device (e.g., an integrated or connectable handle containing the power source).

[0052] It should be understood that the number of electrical conductors 102A, 102B may vary in different embodiments. In some embodiments, a single electrical conductor 102A may be used. In other embodiments, three or more electrical conductors 102A, 102B may be used. Although this specification occasionally refers to multiple electrical conductors 102A, 102B, it should be understood that any embodiment shown or described herein may include only one electrical conductor 102A, or may omit electrical conductors 102A, 102B entirely (e.g., when used with a mechanical separation mechanism 103).

[0053] As shown, the electrical conductors 102A, 102B may extend along the core conductor 101. Figures 1A-5B As shown, the electrical conductors 102A, 102B can terminate at their respective distal ends at electrodes 103A, 103B. In the example embodiments shown in the figures, the first electrical conductor 102A can terminate at the first electrode 103A, and the second electrical conductor 102B can terminate at the second electrode 103B. However, various other configurations can be utilized. For example, in an embodiment having a pair of electrical conductors 102A, 102B, both electrical conductors 102A, 102A can terminate at a single electrode 103A.

[0054] 1-5B , the delivery device 100 may include or be connected to a detachment mechanism 103. The detachment mechanism 103 may be used to detach the implant 105 or other medical device from the delivery device 100 at a desired time. Thus, the detachment mechanism 103 may be located between the delivery device 100 and the implant 105, wherein the detachment mechanism 103 is activated to detach the implant 105 at a target location in the body.

[0055] Various types of separation mechanisms 103 may be used, including but not limited to electrically activated separation mechanisms 103, such as heating coils. Another non-limiting example of a separation mechanism 103 may be composed of various mechanical, electrical, thermal and / or magnetic separation mechanisms 103 known in the art. Non-limiting examples of separation mechanisms 103 include separation mechanisms 103 shown and / or described in U.S. Patent Nos. 10980544, 10265077, 9717500, 9561125, 8460332, 8192480, 8182506 and U.S. Publication Nos. US2006200192, US20090062812, US20090163780, US20100268204, US20110301686, US20150289879, the entire contents of which are incorporated herein by reference.

[0056] In the example implementations shown in the figures, it can be seen that the first electrical conductor 102A can be connected to the distal end of the detachment mechanism 103, and the second electrical conductor 102B can be connected to the proximal end of the detachment mechanism 103. More specifically, the first electrical conductor 102A can be connected to the first electrode 103A at the distal end of the detachment mechanism 103, and the second electrical conductor 102B can be connected to the second electrode 103B at the proximal end of the detachment mechanism 103. However, it should be understood that various other configurations can be utilized in different implementations.

[0057] like Figure 6-9As shown, medical devices, including but not limited to implants 105, such as occlusive devices, can be detachably connected to the distal end of the delivery device 100. The delivery device 100 can deliver various types of medical devices, including but not limited to implants 105, such as embolic devices, etc. Non-limiting examples of deliverable medical devices include medical devices shown and / or described in U.S. Patent Nos. 11166804, 11045205, 10898203, 10729447, 10722687, 10058330, 9381278, 8603128, 6299619 and U.S. Publication Nos. US20210282784, US20190046210, US20180338767, US20170189033, all of which are incorporated herein by reference.

[0058] As shown, all or part of the length of the delivery device 100 can be covered in a sheath 104 or housing that at least partially surrounds or encapsulates the various internal components of the delivery device 100 discussed herein. For example, the sheath 104 or housing can at least partially surround or encapsulate one or more of the core wire 101, the electrical wires 102A, 102B, the separation coil 103, and / or the support structure 110. The type of sheath 104 or housing can vary in different embodiments and can be composed of various types of materials, such as, but not limited to, a PTFE liner or other polymers. In some embodiments, the sheath 104 can include a polymer housing. The dimensions of the sheath 104 or housing (e.g., thickness, width, and ratio to the overall dimensions of the delivery device 100) can also vary in different embodiments.

[0059] As shown, the delivery device 100 can include various structural components that can provide rigidity to the delivery device 100 to help resist kinking. Various embodiments can utilize different types of such structural components. Such structural components can include a combination of structural components composed of shape memory materials and structural components composed of non-shape memory materials. Each of the following example embodiments can include at least two such structural components; including a first structural component composed of a shape memory material and a second structural component composed of a non-shape memory material.

[0060] As previously mentioned, example embodiments of the present invention may include a structural component comprised of a core wire 101. The core wire 101 may be comprised of a non-shape memory material such as stainless steel or the like. The core wire 101 may extend along all or a portion of the length of the delivery device 100. Typically, the core wire 101 may be integrated into the delivery device 100 to provide stiffness to the delivery device 100, which may provide torque transfer and some kink resistance to the delivery device 100. However, where additional kink resistance is desired, one or more additional structural components may be included, as described below. Such additional structural components may be comprised of a shape memory material such as Nitinol or the like.

[0061] In some embodiments, the core conductor 101 can additionally function as an electrical conduit. In such embodiments, the core conductor 101 can be composed of a conductive material so as to conduct electrical current for various purposes. For example, the use of a core conductor 101 that doubles as an electrical conduit can eliminate the need for one or more electrical conductors 102A, 102B. However, in some embodiments, it should be understood that the core conductor 101 can also function as an electrical conduit in addition to one or both of the electrical conductors 102A, 102B, rather than in place of them.

[0062] The use of multiple structural components, including non-shape memory material structural components, such as the core wire 101, and shape memory material structural components, such as the various types of support structures 110 discussed below, can be beneficial in improving the kink resistance of the delivery device 100. Although the core wire 101 does provide some kink resistance, it has been found that the use of the core wire 101 alone may reduce efficiency when used with a larger medical device such as an implant 105 delivered by a relatively small delivery device 100 such as a catheter 115.

[0063] Additionally, welding a shape memory material, such as Nitinol, to a heating coil comprised of, for example, platinum may present challenges. In this regard, it may still be desirable to use a core wire 101 comprised of a non-shape memory material, such as stainless steel, which is more easily welded to such a heating coil. However, as described above, kinking may still occur with devices having larger implants unless additional structural components in addition to the core wire 101 are included. With this in mind, the various example embodiments described below may also include structural components in addition to the core wire 101 to provide additional kink resistance while still maintaining the ease of welding the stainless steel core wire 101 to the heating coil. Such additional structural components may include non-shape memory materials because they do not need to be welded to the heating coil.

[0064] Some embodiments of the detachment mechanism may require an electrical current to heat the stainless steel wire in order to melt the plastic and detach various embolic devices, such as implant 105. Such a detachment mechanism may require the use of stainless steel or other such conductive materials as the core wire 101, as the core wire 101 may need to be welded to the heating coil and included in the circuit. As previously described, in some embodiments, the core wire 101 can therefore be used as an electrical conduit. Therefore, although shape memory materials such as Nitinol have better kink resistance, it is not always possible to replace the core wire 101 with such materials. For these and other reasons, as described below, it may also be desirable to include structural components other than the stainless steel core wire 101.

[0065] In addition to the core wire 101, the structural components of the delivery device 100 may also include one or more support structures 110 extending along all or a portion of its length. Various types of support structures 110 may be utilized. Figure 1A-1B An example embodiment is shown in which the support structure 110 may be composed of conductive wires 111 . Figure 2A-2B An example embodiment is shown in which the support structure 110 may be composed of a tapered wire 111 . Figure 3A-3B An example embodiment is shown in which the support structure 110 may be comprised of a hypotube 112 . Figures 4A-4B An example embodiment is shown in which support structure 110 may be composed of braid 113 . Figure 5A-5B An example embodiment is shown in which the support structure 110 can be composed of a coil 114. Although the above example embodiments of the support structure 110 are shown and described herein separately, it should be understood that in some embodiments, the delivery device 100 can include two or more such configurations (e.g., a support wire 111 and a hypotube 112).

[0066] like Figures 1A-5B As shown, the support structure 110 can extend along the core conductor 101, partially surround the core conductor 101, or completely surround the core conductor 101. In some embodiments, the support structure 110 can be fixed or attached to the core conductor 101, or in other embodiments, it may not be fixed or attached to the core conductor 101. The manner in which the support structure 110 can be fixed or attached to the core conductor 101 can vary in different embodiments.

[0067] As non-limiting examples, the support structure 110 may be secured or attached to the core conductor 101 by welding or soldering. Figure 2B One embodiment is shown, showing weld 106 being used to secure a portion of the length of support structure 110 to a portion of core conductor 101. In other embodiments, support structure 110 may surround or wrap around core conductor 101 in addition to or in lieu of being secured or attached to core conductor 101, such as Figures 4A-5B shown.

[0068] It should be understood that the length of the support structure 110 attached or secured to the core conductor 101 may vary in different embodiments. In some embodiments, as previously mentioned, no portion of the length of the support structure 110 may be attached or secured to the core conductor 101. In other embodiments, a portion of the length of the support structure 110 may be attached or secured to a portion of the length of the core conductor 101. In other embodiments, multiple discrete (i.e., separate) portions of the length of the support structure 110 may be attached or secured to multiple discrete portions of the length of the core conductor 101. In other embodiments, the entire length of the support structure 110 may be attached or secured to the core conductor 101.

[0069] As shown, the support structure 110 can extend parallel to the core conductor 101. In some embodiments, all or a portion of the length of the support structure 110 can extend along and contact all or a portion of the length of the core conductor 101. In other embodiments, the support structure 110 can extend parallel to the core conductor 101, but not contact the core conductor 101. In other embodiments described herein, the support structure 110 can be wrapped or braided around the core conductor 101 instead. Although not shown in the figures, some embodiments can utilize multiple configurations (for example, a first portion of the length of the support structure 110 can extend parallel to the core conductor 101, and a second portion of the length of the support structure can be wrapped, coiled, braided around, or encapsulated around the core conductor 101.

[0070] In embodiments where the support structure 110 partially or completely surrounds the core conductor 101, the support structure 110 may also partially or completely surround one or more electrical conductors 102A, 102B, such as Figures 3A-5B However, in other embodiments, the support structure 110 may partially or completely surround the core conductor 101, but not surround any of the electrical conductors 102A, 102B. In other embodiments, the support structure 110 may partially or completely surround the electrical conductors 102A, 102B, but not surround the core conductor 101.

[0071] The systems and methods described herein can provide kink resistance to the delivery device 100, making the delivery device 100 less prone to kinking, particularly in situations where a large pushing force is required, such as delivering a relatively large medical device such as the implant 105 through a relatively small guide device such as the catheter 115. Thus, the various example embodiments of the delivery device 100 shown and described herein can be configured to traverse tortuous vasculature, such as tight turns, without kinking.

[0072] The systems and methods described herein may also provide a desired stiffness profile and elasticity to the delivery device 100 to facilitate delivery of a medical device such as the implant 105 through a guide device such as the catheter 115 without requiring excessive effort by the operator.

[0073] Figure 1A and 1B An example embodiment of a support structure 110 composed of a support wire 111 is shown. As previously described, the support wire 111 can include a variety of materials, including but not limited to shape memory materials such as Nitinol. In contrast, the core wire 101 can include a non-shape memory material, such as stainless steel, etc. (although in some embodiments, the core wire 104 can also include a shape memory material such as Nitinol).

[0074] Continue to refer Figure 1A and 1B , it can be seen that the support wire 111 can extend along and parallel to the core wire 101. The support wire 111 can extend along the entire length of the core wire 101 (e.g., between the proximal region and the distal region of the delivery device 100), or can extend along only a portion of the length of the core wire 102. As previously described, the support wire 111 can be fixed or attached to the core wire 101 along its entire length, along only a single portion, or along multiple discrete portions, such as by welding or soldering.

[0075] exist Figure 1A and 1B In the example embodiment shown, it can be seen that the diameter or width of the support wire 111 can be greater than the diameter or width of the core wire 101. However, it should be understood that this embodiment should not be construed as limiting the scope, because in some embodiments, the diameter or width of the support wire 111 can be equal to or less than the diameter or width of the core wire 101.

[0076] The figures show an example embodiment in which the support wire 111 includes a circular cross-section. However, it should be understood that the support wire 111 can have a cross-section different from that shown in the figures (e.g., a square or triangular cross-section). The shape, size, length, and configuration of the support wire 111 can vary in different embodiments to accommodate different applications and provide different stiffness profiles for the entire delivery device 100.

[0077] Figure 2A and 2BAn example embodiment is shown in which a portion of both the core wire 101 and the support wire 111 are tapered (i.e., reduced in diameter or width). In the figure, it can be seen that a portion of the length of the core wire 101 can be tapered, and a corresponding portion of the length of the support wire 111 can be similarly tapered to match the taper of the core wire 101. The taper of the core wire 101 and / or the support wire 111 can be desirable to provide a desired stiffness profile for the delivery device 100 (e.g., to prevent or reduce the chance of the delivery device 100 "bouncing back" when traversing tortuous vasculature, such as a sharp turn).

[0078] It should be understood that Figure 2A and 2B The illustrated embodiments should not be construed as limiting. In some embodiments, only one of the core conductor 101 or the support conductor 111 may be tapered. Additionally, in different embodiments, the length of the tapered portion of the core conductor 101 or the support conductor 111 may vary. In some embodiments, the entire length of the core conductor 101 and / or the support conductor 111 may be tapered. In other embodiments, only a portion of the length of the core conductor 101 and / or the support conductor 111 may be tapered. In other embodiments, multiple discrete portions of the length of the core conductor 101 and / or the support conductor 111 may be tapered.

[0079] exist Figure 2A and 2B In the example embodiment shown, it can be seen that the taper of the support wire 111 matches the taper of the core wire 101. More specifically, it can be seen that the length of the tapered region as well as the taper are substantially similar between the support wire 111 and the core wire 101. However, in other embodiments, the length and / or taper of the respective support wire 111 and the core wire 101 may vary and not match as shown in the figures.

[0080] Figure 3A and 3B An example embodiment of a support structure 110 composed of a hypotube 112 is shown. Various types of hypotubes 112 known in the art can be used. Generally, the hypotube 112 can include a cylindrical tube having an inner cavity. The core wire 101 can be positioned within the inner cavity of the hypotube 112. Additionally or alternatively, one or more electrical conductors 102A, 102B can be located within the inner cavity of the hypotube 112.

[0081] The length of the hypotube 112 can vary in different embodiments. The length of the hypotube 112 can be longer, shorter, or equal to the length of the core wire 101 and / or the electrical wires 102A, 102B. In some embodiments, the hypotube 112 can extend between the proximal region and the distal region of the delivery device 100. In other embodiments, the hypotube 112 can extend only a portion of the length of the delivery device 100. In the example embodiment shown in the figure, the distal end of the hypotube 112 can terminate before the proximal end of the detachment mechanism 103. In other embodiments, the hypotube 112 can extend over part or all of the length of the detachment mechanism 103.

[0082] In an embodiment using a hypotube 112 as the support structure 110, as Figure 3A and 3B As shown, the electrical conductors 102A, 102B and / or the core conductor 101 can be sheathed, for example, by a liquid polymer or enamel process. In other embodiments, the electrical conductors 102A, 102B and / or the core conductor 101 can be unsheathed, but simply positioned within the hypotube 112 without any special treatment. In some embodiments, heat shrink can be applied to the electrical conductors 102A, 102B and / or the core conductor 101 before insertion into the hypotube 112. In some embodiments, the hypotube 112 itself can be used as an electrical contact.

[0083] The length, size, shape, and configuration of the hypotube 112 may vary in different embodiments. Generally, the hypotube 112 may have a sufficient diameter to fit the electrical conductors 102A, 102B, and / or the core conductor 101 within its lumen. The inner diameter of the hypotube 112 may be substantially similar to the outer diameter of the electrical conductors 102A, 102B, and / or the core conductor 101, or may be greater than the outer diameter of the electrical conductors 102A, 102B, and / or the core conductor 101 so that there is additional space therein.

[0084] The hypotube 112 may be composed of a variety of materials. For example, the hypotube 112 may be composed of metals, metal alloys, polymers, etc. In one example embodiment, the hypotube 112 may be composed of a shape memory material. In one such example embodiment, the hypotube 112 may be composed of Nitinol.

[0085] Figure 4A and 4BAn example embodiment of a support structure 110 composed of a braid 113 is shown. The braid 113 is typically woven around all or part of the length of the core conductor 101 to provide support thereto. The braid 113 can be composed of various materials, such as, but not limited to, metals, metal alloys, polymers / polyesters (e.g., PET or PEN), various fibers (e.g., Kevlar, fiberglass, carbon fiber), etc., or various combinations of the above materials.

[0086] In one example embodiment, braid 113 may be comprised of a shape memory material. In one such example embodiment, braid 113 may be comprised of nitinol. Braid 113 may be comprised of only a single material, or in some embodiments, may be comprised of multiple materials (e.g., braid 113 may be comprised of both nitinol and stainless steel by incorporating stainless steel into the braid).

[0087] The configuration (e.g., weaving pattern) of the braid 113 may vary in different embodiments. By way of example and not limitation, the braid 113 may be composed of a fully loaded weaving pattern, a standard weaving pattern, a diamond weaving pattern, a one-to-one (i.e., half-loaded) weaving pattern, a one-to-one-under weaving pattern, a two-to-one-under-two weaving pattern, a chasing line weaving pattern, a triaxial weaving pattern, a coil weaving pattern, etc. Therefore, it should be understood that various weaving patterns known in the art may be used for the braid 113 to provide the support structure 110 with the desired stiffness profile and other characteristics.

[0088] It should also be understood that various other features of braid 113 may be different in different embodiments. For example, the number of carriers used in braid 113 can change. As an example and not a limitation, braid 113 can be composed of 4, 8, 16, 24 or 48 carriers. The braiding angle and density (such as weft yarn per inch) of braid 113 can also change in different embodiments. Therefore, the example embodiments shown in the figure should not be interpreted as limiting the configuration of braid 113 shown and the scope of characteristics.

[0089] The braid 113 generally includes one or more wires or strands that are wound or woven into a generally tubular pattern. Although the figures show a braid 113 having a substantially circular cross-section, it should be understood that in some embodiments, the braid 113 can have a cross-section of a different shape (e.g., a triangle, a rectangle, or a hexagon). In addition, in different embodiments, the width or diameter of the tube formed by the braid 113 can vary. Typically, the width or diameter of the tube formed by the braid 113 will be substantially the same as or larger than the components (e.g., the core wire 101 and / or the electrical wires 102A, 102B) located therein.

[0090] It should be understood that the drawings herein, particularly Figures 4A-4B , are not drawn to scale. Therefore, the spacing, orientation, size, and number of wires forming braid 113 should not be construed as being limited to the example embodiments shown in the drawings. In different embodiments, the number of wires or strands used to form braid 113 can vary. Therefore, braid 113 can use more or fewer wires or strands than shown. For example, braid 113 can include any number of wires or strands, in some embodiments, include one wire or strand, or in other embodiments include more than one wire or strand.

[0091] The braid 113 can be woven or wrapped around the entire length or only a portion of the length of the core wire 101. In some embodiments, the braid 113 can extend between the proximal region and the distal region of the delivery device 100. In one example embodiment as shown, the distal end of the braid 113 can terminate at or near the proximal end of the detachment mechanism 103. In other embodiments, the braid 113 can extend over the detachment mechanism 103.

[0092] Figure 5A and 5B An example embodiment of a support structure 110 consisting of a coil 114 is shown. The coil 114 itself can be composed of one or more wound wires. Typically, the coil 114 can be wound or coiled around the core wire 101 and / or the electrical wires 102A, 102B, as shown.

[0093] The coil pattern may be different from that shown in the example embodiments of the accompanying drawings. In addition, the number of turns and the turn distance of the coil 114 may vary in different embodiments. In addition, the direction of the winding (e.g., right-handed winding or left-handed winding) may also be different in different embodiments.

[0094] like Figure 5A and 5B As shown, coil 114 can be wrapped or coiled around core conductor 101 and / or electrical conductors 102A, 102B. Coil 114 can be close to core conductor 101 and / or electrical conductors 102A, 102B, or can be loosely wrapped. Coil 114 can extend all or part of the length of core conductor 101 and / or electrical conductors 102A, 102B. In the example embodiment shown in the drawings, it can be seen that the distal end of coil 114 can terminate at or near the proximal end of separation mechanism 103. In other embodiments, coil 114 can extend above separation mechanism 103.

[0095] Figure 6-9 Various embodiments of an exemplary delivery device 100 including an attached implant 105 are shown. Figure 6An example embodiment of a delivery device 100 is shown that includes a support structure 110 comprised of a support wire 111 including an attached implant 105 . Figure 7 An example embodiment of a delivery device 100 is shown that includes a support structure 110 comprised of a hypotube 112 including an attached implant 105 . Figure 8 An example embodiment of a delivery device 100 is shown that includes a support structure 110 composed of a braid 113 including an attached implant 105 . Fig. 9 An example embodiment of a delivery device 100 is shown that includes a support structure 110 comprised of a coil 114 including an attached implant 105 .

[0096] To keep it simple, Figure 6-9 Embodiments are shown in which the support structure 110 does not extend the entire length or a substantial portion of the length of the delivery device 100, such as the delivery catheter 115. However, it should be understood that the support structure 110 can extend more of the length of the delivery device 100 than the example embodiments shown in these figures. For example, in some embodiments, the support structure 110 can extend substantially the entire length of the delivery device 100, such as between a proximal region and a distal region of the delivery device, such as the delivery catheter 115. The support structure 110 can terminate prior to the detachment mechanism 103, or can extend along or over the detachment mechanism 103. The sheath 104 can extend over all, a portion, or all of the length of the support structure 110.

[0097] When in use, the support structure 110 is generally used to provide kink resistance to the delivery device 100, so that the delivery device 100 is less prone to kinking when delivered to a target location in a patient's body by an external guide device such as an introducer or catheter 115. Previously, unsupported delivery devices 100 (e.g., delivery devices 110 without any support structures 110 described herein) were prone to kinking during delivery; particularly when traversing tortuous vasculature, such as, but not limited to, the aortic arch. The systems and methods described herein utilize support structures 110 to resist such kinking. In addition, the use of any support structure 110 shown or described herein can be used to provide a desired stiffness distribution for all or a portion of the length of the delivery device 100 to improve its function.

[0098] The systems and methods shown and described herein may be particularly suitable for advancing a larger medical device 105, such as an implant, into a smaller catheter 115. Typically, delivering a larger medical device 105, such as an implant, requires a large force to advance, especially if the diameter of the catheter 115 through which the medical device 105 is advanced is relatively small. Even when delivering a larger medical device 105 through a relatively small catheter 115, the use of any support structure 110 shown and described herein can help reduce the likelihood of kinking. The support structure 110 can also provide elasticity to the delivery device to further reduce kinking and other undesirable reactions of the delivery device 100 being advanced into the catheter 115.

[0099] Although the present invention has been described according to specific embodiments and applications, according to this teaching, those skilled in the art can produce other embodiments and modifications without departing from the spirit of the claimed invention or exceeding its scope. Therefore, it should be understood that the drawings and descriptions herein are provided by way of example to facilitate understanding of the present invention and should not be interpreted as limiting its scope.

Claims

1. A delivery device for delivering a medical device, comprising: A core conductor, wherein the core conductor is composed of a non-shape memory material; and A support structure extends between the proximal region and the distal region of the pushrod, the support structure comprising a shape memory material.

2. The delivery device according to claim 1, wherein: The support structure extends along the core conductor.

3. The delivery device according to claim 1, wherein: The core conductor is at least partially surrounded by the support structure.

4. The delivery device according to claim 1, wherein: The non-shape memory material is stainless steel.

5. The delivery device according to claim 1, wherein: The support structure includes a hypotube.

6. The delivery device according to claim 5, wherein: The hypotube surrounds one or more electrical conductors that are connected to a heating coil on the distal end of the pushrod.

7. The delivery device of claim 1, wherein: The support structure includes a support wire.

8. The delivery device of claim 7, wherein: At least a portion of the support wire is tapered.

9. The delivery device of claim 8, wherein: At least a portion of the core conductor is tapered.

10. The delivery device of claim 7, wherein: The core wire is composed of stainless steel, and wherein the support wire is composed of Nitinol.

11. The delivery device of claim 1, wherein: The support structure includes a braid.

12. The delivery device of claim 11, wherein: The braid surrounds one or more electrical conductors that are connected to a heating coil on the distal end of the pushrod.

13. The delivery device of claim 1, wherein: The support structure includes a coil.

14. The delivery device of claim 1, wherein: The shape memory material is Nitinol.

15. The delivery device of claim 1, wherein: The distal region of the pushrod includes a distal tip of the pushrod.

16. The delivery device of claim 1, wherein: The proximal region of the push rod includes a push rod handle.

17. A delivery system for delivering a medical device, comprising: A core conductor, wherein the core conductor is composed of a non-shape memory material; Separation of institutions; a pair of electrical conductors connected to the separation mechanism; and A support structure extends between the proximal region and the distal region of the pushrod, the support structure comprising a shape memory material.

18. The delivery system of claim 17, wherein: The support structure extends parallel to the core conductor and the pair of electrical conductors.

19. The delivery system of claim 17, wherein: The support structure at least partially surrounds the core conductor and the pair of electrical conductors.

20. The delivery system of claim 17, wherein: The support structure includes a hypotube.

21. The delivery system of claim 17, wherein: The support structure includes a support wire.

22. The delivery system of claim 21, wherein: The core wire is composed of stainless steel, and wherein the support wire is composed of Nitinol.

23. The delivery system of claim 17, wherein: The support structure includes a braid.

24. The delivery system of claim 23, wherein: The braid surrounds the pair of electrical conductors.

25. The delivery system of claim 17, wherein: The support structure includes a coil.

26. The delivery system according to 25, wherein The coil is wound around the core wire and the pair of electrical wires.

27. A push rod for delivering a medical device through a lumen, comprising: A rigid device, which is used to provide rigidity to the push rod, wherein the rigid device is composed of a non-shape memory material; and An anti-kink device for supporting the rigidizing device extends between the proximal and distal regions of the push rod and includes a shape memory material.

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