Mechanical Separation System for Transcatheter Devices
The mechanical separation system for trans-catheter devices addresses the challenges of endovenous ablation by using a shape memory polymer implant with a press fit and release mechanism, ensuring controlled and safe delivery with tactile feedback.
Patent Information
- Application Number
- JP2023508480
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-08-21
- Filing Date
- 2021-08-20
- Publication Date
- 2025-07-29
- Estimated Expiration
- 2041-08-20
AI Technical Summary
Existing treatments for chronic venous insufficiency, such as endovenous ablation, cause patient discomfort and complications like pain, nerve damage, and require precise control to avoid recanalization, while existing delivery mechanisms for trans-catheter implants lack efficient release and control mechanisms.
A mechanical separation system for trans-catheter devices using a shape memory polymer (SMP) implant with a press fit and release mechanism, involving wires and conduits, allows for controlled advancement, retraction, and immediate release at the target site, providing tactile feedback and enhanced safety.
The system enables faster, safer, and more controlled delivery of trans-catheter implants with reduced risk of premature separation, offering improved patient comfort and procedural safety.
Smart Images

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Abstract
Description
Technical Field
[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 068,533, filed on August 21, 2020, entitled "Mechanical Separation System for Trans - Catheter Devices", the content of which is incorporated herein by reference.
[0002] Embodiments of the present invention pertain to the field of medical devices, particularly trans - catheter devices.
Background Art
[0003] In the United States, an estimated six million people suffer from severe symptoms of chronic venous insufficiency. The symptoms range from dramatic skin changes to painful, non - healing ulcers, which are often seen in the lower extremities. Chronic venous insufficiency is caused by weakened venous valves that can no longer prevent backflow in the peripheral veins that carry blood to the heart, resulting in a sudden increase in venous pressure. This high blood pressure can lead to the formation of varicose veins and venous ulcers. The most common area for the treatment of chronic venous insufficiency is the great saphenous vein. Previous treatment methods for the manifestation of chronic venous insufficiency included manual compression, surgical ligation and stripping, sclerotherapy, and endovenous ablation of the great saphenous vein. Endovenous ablation has many drawbacks. With endovenous ablation, the patient experiences pain either from anesthetic injection or laser treatment. Furthermore, the physician must ablate the entire cross - section of the vein evenly and control the retraction speed of the laser, so recanalization may occur. Many other complications may result, such as deep vein thrombosis, bruising, sensory impairment, skin burns, bruising, thrombophlebitis, and nerve damage.
[0004] U.S. Patent Application 20190015108 describes embodiments that use a polyurethane shape memory polymer (SMP) foam to selectively occlude areas of the vasculature that may be caused by complications due to continuous blood flow. Due to the form and chemical properties of the foam, it can be compressed, loaded into an inserter, and advanced through a catheter to the target area. When in contact with circulating blood, the foam expands (e.g., within 2, 4, 6, 8, or 10 minutes after contact with blood) to its original shape and completely occludes the blood vessel lumen. This procedure utilizes minimally invasive techniques.
[0005] U.S. Patent Application 20190015108 further provides that embodiments can utilize several delivery mechanisms. One such mechanism is a core wire placed within the volume of the foam implant, with the implant crimped onto the core wire to create friction between the implant and the core wire. The friction allows the device to be retracted and advanced within the lumen of the treated blood vessel until the device is fully expanded. When the device is fully expanded, the friction is reduced sufficiently so that the core wire can be retracted through the volume of the device.
[0006] U.S. Patent Application 20190015108 describes another delivery mechanism where the device is simply advanced through a catheter using a guide wire or a pusher mechanism until the device is completely discharged from the delivery catheter. Another delivery mechanism is one where the proximal end of the device is attached to a pusher mechanism via an exposed stainless steel wire. When the device is delivered to the target blood vessel, an electric current is applied to the pusher mechanism, thereby causing electrolysis of the exposed stainless steel wire and effectively releasing the implant from the pusher mechanism.
Brief Description of the Drawings
[0007] The features and advantages of the embodiments of the present invention will become apparent from the appended claims, the following detailed description of one or more exemplary embodiments, and the corresponding figures. Where appropriate, reference numerals are repeated between the figures to indicate corresponding or similar elements.
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[0015] Here, reference is made to the drawings, in which like reference numerals may be provided for like structures. For the sake of more clearly showing the structures of various embodiments, the drawings included in this specification are schematic representations of the structures. Therefore, although the actual appearance of the fabricated structure, for example, in a micrograph, may look different, on the other hand, it still incorporates the claimed structure of the illustrated embodiment. Also, the drawings may show only the structures useful for understanding the illustrated embodiments. To maintain the clarity of the drawings, additional structures known in the art may not be included. Expressions such as “embodiment,” “various embodiments,” etc. indicate that the embodiments so described may include certain features, structures, or characteristics, but not all embodiments necessarily include the specific features, structures, or characteristics. Some embodiments may have some or all of the features described for other embodiments, or may have none of these features. “First,” “second,” “third,” etc. describe common objects and indicate that different instances of the same object are being referred to. Such adjectives do not imply that the objects so described must be in a given order in terms of time, space, ranking, or any other method. “Connected” may indicate that a plurality of elements are in direct physical contact with each other or in electrical contact, and “coupled” indicates that a plurality of elements may interact or operate in conjunction with each other, but they may or may not be in direct physical or electrical contact. Expressions such as “comprising at least one of A and B” include situations having A, B, or both A and B.
[0016] Embodiments include a system capable of advancing and retracting an implant delivered via a catheter when it is inside a catheter or delivery sheath and also after placement from the catheter / sheath. The system includes a mechanism that can immediately release the implant at the target position during operation. Thus, such a system has advantages over the above-described systems that rely on electrolysis, for example, as a release mechanism. Such advantages include faster release, tactile feedback to the user during release, and ease of manufacture.
[0017] Embodiments have the ability to advance and retract an implant delivered via a catheter before delivering it to the target site. Then, immediate separation of the implant occurs when desired. This increases the safety and comfort of delivering and manipulating minimally invasive implants.
[0018] Some embodiments are composed of a press fit between the implant and the delivery system during final assembly, such that the implant can be pushed or pulled until the physician attempts to release it. Such embodiments include means for removing the press fit, either by withdrawing the delivery sheath or pulling a release wire, whereby the implant is immediately and effectively delivered.
[0019] Embodiments may be used to deliver a transcatheter medical implant and enable operation of the device before release. An alternative use is to deliver any device via a needle, sheath, catheter, arthroscopic procedure, or other method when space is limited. Embodiments may be used, for example, by vascular surgeons, interventional radiologists, and cardiothoracic surgeons.
[0020] Embodiments have increased tensile strength in the delivery system, which can more easily prevent premature separation and, through the design of the interlocking components, can obtain a more reliable separation. Embodiments maintain control of the implant in both compression and tension until delivery of the implant is desired.
[0021] Example 1 Example 1 includes a system comprising an implant having a shape memory polymer (SMP) (101) and a color (102). The system further comprises a first (103) and a second (104) wire, and a coil (105) having the first wire. Wire 104 may be a flat retaining wire. Wire 103 may be a round wire. The system comprises a first conduit (106) that is (a) coupled to the coil and (b) has the second wire. Conduit 106 may be an X-ray impermeable band comprising platinum and / or iridium (e.g., an alloy or combination of platinum and / or iridium). Other embodiments may have an X-ray impermeable band comprising platinum and / or tungsten (e.g., an alloy or combination of platinum and / or tungsten). The band may comprise stainless steel or other materials. The system further comprises a second conduit (107) that couples the first wire to the second wire. At least a portion of the color is between the SMP and the coil. The color includes a channel (108), a first hole (109) in a first sidewall of the color, and a second hole (110) in a second sidewall of the color. The channel couples the first hole to the second hole. The channel may be a through hole in the color. The second wire is (a) contained within the channel, (b) passes through the second sidewall hole, and (c) is between the color and the first conduit.
[0022] For example, in FIG. 1, the embodiment includes an implant that includes an SMP foam and a color. The entire implant is separated from the delivery coil. The delivery mechanism may include a first wire such as a round wire and a second wire such as a flat retention wire. The coil may include the first wire. A first conduit such as a platinum / iridium, platinum / tungsten, or stainless steel band is (a) coupled to the coil and (b) includes the second wire. A second conduit such as a centered hypodermic tube couples the first wire to the second wire. At least a portion of the color is between the SMP and the coil. The color includes a channel, a first hole in a first sidewall of the color, and a second hole in a second sidewall of the color. The channel couples the first hole to the second hole. The second wire is (a) contained within the channel, (b) passes through the second sidewall hole, and (c) is between the color and the first conduit.
[0023] As used herein, a "hypodermic tube" may be considered a conduit in a broad sense. A conduit may include metal, but is not limited to metal only and may include, for example, a polymer. A conduit need not be a tube. A conduit used herein may be hollow or solid along a part or all of its length. For example, a conduit may include a major axis, and a plane orthogonal to the major axis need not necessarily intersect the outer periphery of a continuous tube. For example, a slot may have a cross-sectional profile such as a "U" shape.
[0024] Example 2 The system according to Example 1, wherein the second wire is contained within the first hole.
[0025] Example 3 The system according to Example 2, wherein a first plane (111) intersects the first conduit, the second wire, the color, and the second hole. The first plane does not intersect the first hole.
[0026] For example, refer to the "first plane" in FIG. 1.
[0027] Example 4 The system of Example 3, wherein a second wire is coupled between the first conduit and the collar via a resistance fit (112). The resistance fit is removed when the first wire is moved proximally away from the collar. When the resistance fit is removed, the implant is deployed from the first conduit.
[0028] For the region of the “resistance fit,” see, for example, FIGS. 2A, 2B, and 2C. The “resistance fit” provides sufficient resistance so that the physician can repeatedly move the entire system back and forth (proximally and distally) before final placement of the implant, without prematurely decoupling the implant from the delivery coil. However, when the physician firmly holds the coil and pulls the round wire link proximally, the resistance is overcome and the retention wire is pulled out of the region of collision that creates the resistance fit. The circular region of FIG. 1 shows one region of resistance, although resistance may occur in other regions of the retention wire, such as within the second aperture.
[0029] Example 5 An embodiment includes a system comprising an implant having an SMP (501) and a collar (502). The system includes a first (503) and a second (504) wire, a coil (506) including the first wire, and a first conduit (507) that (a) is coupled to the coil and (b) has the second wire. The system includes a second conduit (508) that couples the first wire to the second wire. At least a portion of the collar is between the SMP and the coil. The collar has a first aperture (509) in a sidewall of the collar. The second wire is (a) contained within the first aperture, (b) passes through an opening toward the first aperture, and (c) is between the collar and the first conduit.
[0030] For example, refer to FIG. 5. The SMP may be an SMP foam having a secondary shape and a primary shape, and the foam may be configured to transition from the secondary shape to the primary shape based on exposure to heat. The first wire may include a "pull wire", and the second wire may include a flattened wire. Embodiments may include a first conduit such as a chamfered band. The second conduit may include a hypo tube used to center the system. The first hole may include a through hole. However, in some embodiments, the first hole may not necessarily pass through the collar. As shown in FIG. 5, the second wire is (a) contained within the first hole, (b) passes through an opening towards the first hole, and (c) is between the collar and the first conduit.
[0031] Coil 506 may include polyimide. Wire 503 may include a stainless steel pull wire. Conduit 508 may include a centering hypo tube. Wires 504, 505 may include flattened stainless steel or nitinol wires. Band 507 may include a chamfered portion. The chamfered portion of the system and the retaining wire push the implant forward and downward in the ground frame of FIG. 4B. Thereby, in some vascular embodiments, the foam moves towards the vessel wall (FIG. 5D). In other words, the arrow pointing to the right is simply a distal movement, but when the implant moves distally, instead, the chamfered system drives the implant downward. Holes 509, 510 may include drill through holes in the collar. Collar 502 may be radiopaque and may include platinum and / or iridium (e.g., an alloy or combination of platinum and / or iridium). Other embodiments may have a radiopaque collar including platinum and / or tungsten (e.g., an alloy or combination of platinum and / or tungsten). The band may include stainless steel or other materials. In another embodiment, the collar includes stainless steel.
[0032] Figures 5A - 5D show embodiments that do not show the SMP foam in order to focus on the color and overall delivery system. The embodiments of Figures 5A - 5D are similar to the embodiments of Figures 4A - 4B. However, in Figures 5A - 5D, the natural state of the retention wire is linear. Figure 5A shows a flattened wire attached to a centered hypodermic tube either by soldering or welding. Figure 5B shows that when the attachment joint is assembled, there are several forces (compressive force 513, frictional force 514, retention force 515) introduced into the assembly. Figure 5B further shows a chamfer 516. Figure 5C shows that during operation, as the bent tip of the flattened wire moves away from the drill-through hole; the frictional forces from the two flattened wires that tend to return to their initial state accumulate in addition to the compressive force. The chamfered stainless steel band restricts the color from going in the "pulled" direction. Figure 5D shows that when separation occurs between the pull wire and the implant color, the compressive force is applied to the implant color to release the color from its restraint.
[0033] Example 6 The system of Example 5, wherein the most distal edge of the first conduit is chamfered.
[0034] The chamfer includes an inclined edge such as the edge of Figure 5.
[0035] Example 7 The system of Example 5, wherein the most distal edge of the first conduit includes a first (511) and a second (512) portion. The first portion is more distal than the second portion.
[0036] See, for example, Figure 4A with respect to the first and second portions.
[0037] Example 8 The system of Example 7, wherein the first and second portions form opposing edges of a hole. The hole has an opening defined by the first and second portions.
[0038] For example, the hole is an area where a portion of the color will be finally disposed during the placement of the implant towards the final implantation.
[0039] Example 9 The system according to any one of Examples 5 to 8, comprising a third wire, wherein the first conduit has the third wire (505); the second conduit couples the first wire to the third wire; and the collar has a second hole (510) in the side wall of the collar. The third wire is (a) contained within the second hole, (b) passes through an opening towards the second hole, and (c) is between the collar and the first conduit.
[0040] The "third wire" may be the second of two or more wires (504, 505) and may include a flattened stainless steel or nitinol wire. Not all embodiments require two retention wires. There are embodiments that may include only one retention wire, and there are also embodiments that may include three, four, five, or more retention wires.
[0041] Example 10 The system according to Example 9, wherein a through hole passes through the collar and couples the first hole to the second hole.
[0042] For some embodiments, the hole passes through the entire portion of the collar, while in other embodiments, one or more holes may simply be depressions or recesses in a portion of the collar.
[0043] Example 10.1 The system according to Example 9, wherein most of the second wire is contained in a plane. Most of the third wire is contained in a plane.
[0044] This configuration facilitates generating sufficient holding force to reduce or minimize the possibility that the implant will prematurely separate from the delivery coil before the physician pulls the pull wire.
[0045] Example 10.2 The system according to Example 10.1, wherein the first wire includes the major axis. The plane is substantially parallel to the major axis of the first wire.
[0046] Example 10.3 The system according to Example 9, wherein each of the second and third wires is planarized.
[0047] In some embodiments, planarizing one or both of the second and third wires facilitates restricting the profile of the delivery system. For example, the maximum outer diameter (see FIG. 5) may be smaller. For example, in an embodiment, the wire has a non-circular cross-section. For example, using the X, Y, Z coordinate system in FIG. 5, the wire may be wider in the Z direction than their height in the Y direction.
[0048] Example 11 The system according to Example 5, wherein the first hole has a through-hole passing through the collar.
[0049] Example 12 The system according to Example 9, wherein in a first orientation, the second wire is included in the first hole, whereby the collar and the SMP are fixed to the first wire. In a second orientation, in response to the first and second wires being pulled in the proximal direction and the second wire being pulled out of the first hole, the collar and the SMP are no longer fixed to the first wire.
[0050] In the embodiment of FIG. 5, when the pull wire is pulled in the proximal direction to release the implant, there is some resistance between the second and third retention wires and the collar. This resistance causes the implant itself to move in the proximal direction and pivot about the first portion of the distal-most edge towards the second portion of the distal-most edge. As a result, the proximal portion of the collar moves in the proximal direction. When the retention wires (second and third wires) no longer pull the collar in the proximal direction, as long as there is a "release" or surge or thrust of the foam, the foam is slightly propelled away from the "first portion of the distal-most edge" and possibly towards the blood vessel wall. In other words, instead of protruding distally (see FIG. 5), the foam protrudes towards the blood vessel wall instead, thereby immediately stopping the advancement of the foam. Consequently, the foam does not shift significantly from the location where the physician positioned the foam before pulling the pull wire. In other words, by ensuring that the thrust of the foam is rapidly reduced by the adjacent blood vessel wall, the chamfer makes it easier to hold the foam in place upon release.
[0051] Other embodiments may function in different ways. For example, in an embodiment, when the pull wire is pulled in the proximal direction to release the implant, there is a certain amount of resistance between the second and third retention wires and the collar. However, the first portion of the most distal edge may prevent the collar from moving in the proximal direction. Still, the collar needs to be discharged from the coil / delivery system. To that end (see, e.g., FIGS. 5A-5D), when the retention wire releases the collar, the retention wire may "spring" back to its original state. In doing so, when the retention wire (or wires) springs back to its / their original undeformed state, it / they push the collar out of the coil and the first conduit. This solves the problem of how to position the collar while ensuring that the implant is not prematurely released. In other words, to prevent the implant from being prematurely released while the physician moves the implant back and forth to find the final placement site, the retention wire may supply both a resistance fit (e.g., between the collar and the coil) and a compressive force (e.g., of the wire pushed into the hole of the collar). The same wires that hold the collar within the delivery system to prevent premature placement can also facilitate pushing the collar out of the delivery system due to their deformation from their deformed state to their undeformed state.
[0052] Some embodiments may include a beveled portion in the first conduit, while other embodiments do not have such a requirement. A physician may prefer, for example, a non-beveled option for one type of case (such as placement of a foam within an intracranial aneurysm), and a beveled option for another type of case (such as placement of a foam within a blood vessel in the thigh). The need for a beveled portion may also vary depending on the protrusion force generated thereby if there is a retention wire. For example, if the protrusion force is small, a beveled option may not be necessary. In some embodiments, the retention wire may not need to apply little or no protrusion force to the implant. For example, in some embodiments, when the retention wire is withdrawn, the amount of remaining frictional force applied to the collar by the delivery system may be very small, such that, for example, blood that causes embolization within an SMP foam (or other embolization device) may generate sufficient resistance against the implant, such that the delivery system can be withdrawn without moving the implant from its desired implanted position. Such low propulsion force may be desirable in some cases, such as when placing a foam in an intracranial aneurysm that has a thinner vessel wall (and is less resistant to embolic elements propelled from the delivery system) than the vessel wall in the peripheral blood vessels in the thigh.
[0053] Example 13 The system of Example 12, wherein the second wire has elasticity.
[0054] For example, nitinol is considered to "have elasticity".
[0055] Example 14 The system of Example 13, wherein the second wire comprises at least one of stainless steel, nickel titanium, or a combination thereof.
[0056] Example 14.1 The system of Example 12, wherein the second wire has shape memory.
[0057] Shape memory refers to the ability, for example of nitinol, to be deformed at one temperature, remain in that deformed shape when the external force is removed, and then return to its original undeformed shape when heated above that "transformation temperature".
[0058] Example 14.2 The system according to Example 12, wherein the second wire has superelasticity.
[0059] Superelasticity refers to the ability of a metal to undergo large deformations and immediately return to its undeformed shape when the external load is removed. These materials can withstand high strains without plastic deformation. For example, nitinol can deform 10 to 30 times that of ordinary metals and return to its original shape.
[0060] Example 14.3 The system according to Example 12, wherein the second wire has at least one of shape memory or superelasticity.
[0061] Example 14.4 The system according to Example 14.3, wherein the second wire has a deformed state and an undeformed state; in the deformed state, the second wire is non-linear; and in the undeformed state, the second wire is linear.
[0062] Example 14.5 The system according to Example 14.4, wherein the second wire is in a deformed state and at least a portion of the second wire is contained within the first hole.
[0063] Example 14.6 The system according to Example 14.5, wherein the second wire is in a deformed state and includes at least one curved portion that curves around a portion of the collar and enters the first hole.
[0064] Embodiments are not limited to the shape of the retention wire as seen in FIGS. 4A - 5D. For example, some embodiments include two wires that collectively form a "V" shape. The spacing between the wires may limit the force that projects the implant from the delivery system.
[0065] Example 14.7 The system according to Example 14.3, wherein the second wire has a deformed state and a non-deformed state; and the second wire is in the deformed state.
[0066] Example 14.8 The system according to Example 14.7, wherein in the deformed state, the second wire generates (a) a frictional force between the collar and the first conduit, and (b) a compressive force against the collar.
[0067] Example 14.90 The system according to Example 14.8, wherein when transitioning from a first orientation to a second orientation, the second and third wires transition from a deformed state to a non-deformed state. In response to the second and third wires transitioning from the deformed state to the non-deformed state, the collar is propelled away from the first conduit.
[0068] Example 14.91 The system according to Example 14.90, wherein the first wire includes a long axis. In response to the second and third wires transitioning from the deformed state to the non-deformed state, the collar is propelled away from the first conduit along a direction. This direction is non-parallel to the long axis of the first wire.
[0069] In an embodiment, when the retention wires are pulled in the proximal direction, they pull the collar in the proximal direction. However, due to the chamfer, the implant receives a rotational force centered on the most distal edge of the chamfer. When the retention wires snap back to their initial state, they provide a pressing force that pushes the implant away from the delivery system at an angle such that the implant is pushed laterally and not directly aligned with the long axis of the coil and / or the first wire. Note how the implant rotates downward in the lower depiction of FIG. 5D.
[0070] Example 15 The embodiments include a system comprising an implant that includes an SMP and a base portion, where the SMP and the base portion are permanently attached to each other. The system includes a link portion; a first elastic metal member; a first conduit including the link portion; and (a) a second conduit coupled to the first conduit and (b) including the first elastic metal member. The link portion is coupled to the first elastic metal member. At least a portion of the base portion is between the SMP and a portion of the first conduit. The base portion includes a first hole in a sidewall of the base portion. The first elastic metal member is (a) included within the first hole, (b) passes through an opening toward the first hole, and (c) is between the base portion and the second conduit.
[0071] Accordingly, not all embodiments are disclosed in FIG. 5. For example, a “centered hypo” tube may or may not be included in some embodiments.
[0072] Example 15.1 The system according to Example 15, wherein the link portion includes at least one of a cord, a cable, a line, a string, a rod, a wire, a bar, a coil, or a combination thereof.
[0073] Example 16 The system according to Example 15, wherein a distal edge of the second conduit is chamfered.
[0074] Example 17 The system according to Example 15, wherein a distal edge of the second conduit includes first and second portions, and the first portion is distal to the second portion.
[0075] Example 18 The system according to Example 17, wherein the first and second portions form opposing edges of a hole, and the hole has an opening defined by the first and second portions.
[0076] Example 19 The system according to any one of Examples 15 to 18, comprising a second elastic metal member. The second conduit includes the second elastic metal member. The link portion is coupled to the second elastic metal member. The base portion includes a second hole in a side wall of the base portion. The second elastic metal member is (a) contained within the second hole, (b) passes through an opening toward the second hole, and (c) is between the base portion and the second conduit.
[0077] Example 20 The system according to Example 19, wherein a through hole passes through the base portion and connects the first hole to the second hole.
[0078] Example 20.1 The system according to Example 19, wherein most of the first elastic metal member is contained in a plane. Most of the second elastic metal member is contained in a plane.
[0079] Example 20.2 The system according to Example 20.1, wherein the link portion includes a major axis. The plane is substantially parallel to the major axis of the link portion.
[0080] Example 20.3 The system according to Example 19, wherein each of the first and second elastic metal members is flattened.
[0081] Example 21 The system according to Example 15, wherein the first hole has a through hole passing through the base portion.
[0082] Example 22 In a first orientation, the base portion and the SMP are fixed to the link portion by including a first elastic metal member within the first hole. In a second orientation, the link portion and the first elastic metal member are pulled in the proximal direction, and in response to the first elastic metal member being discharged from the first hole, the base portion and the SMP are no longer fixed to the link portion.
[0083] Example 23 The system according to Example 22, wherein the first elastic metal member includes at least one of stainless steel, nickel titanium, or a combination thereof.
[0084] Example 24.1 The system according to Example 22, wherein the first elastic member has shape memory.
[0085] Example 24.2 The system according to Example 22, wherein the first elastic member has superelasticity.
[0086] Example 24.3 The system according to Example 22, wherein the first elastic member has at least one of shape memory or superelasticity.
[0087] Example 24.4 The system according to Example 24.3, wherein the first elastic member has a deformed state and an undeformed state. In the deformed state, the first elastic member is non-linear. In the undeformed state, the first elastic member is linear.
[0088] Example 24.5 The system according to Example 24.4, wherein the first elastic member is in a deformed state, and at least a portion of the first elastic member is contained within the first hole.
[0089] Example 24.6 The system according to Example 24.5, wherein the first elastic member is in a deformed state and includes at least one curved portion that curves around a portion of the color and enters the first hole.
[0090] Example 24.7 The system according to Example 24.3, wherein the first elastic member has a deformed state and an undeformed state. The first elastic member is in the deformed state.
[0091] Example 24.8 In the deformed state, the system according to Example 24.7, wherein the first elastic member generates (a) a frictional force between the base portion and the second conduit, and (b) a compressive force against the base portion.
[0092] Example 24.90 When transitioning from the first orientation to the second orientation, the system according to Example 24.8, wherein the first and second elastic members transition from a deformed state to an undeformed state. In response to the first and second elastic members transitioning from the deformed state to the undeformed state, the base portion is propelled away from the second conduit.
[0093] Example 24.91. The system according to Example 24.90, wherein the link portion includes the major axis. In response to the first and second elastic members transitioning from a deformed state to an undeformed state, the base portion is propelled away from the second conduit along a direction that is non-parallel to the major axis of the link portion.
[0094] Example 25 An embodiment includes a system comprising an implant having a shape memory polymer (SMP) and a base portion. The SMP and the base portion are permanently attached to each other. The system includes a link portion; a first elastic metal member; a first conduit including the link portion; and a second conduit that is (a) coupled to the first conduit and (b) includes the first elastic metal member. The link portion is coupled to the first elastic metal member, and at least a portion of the base portion is between the SMP and a portion of the first conduit. The base portion includes a first hole in a sidewall of the base portion. The first elastic metal member is (a) contained within the first hole, (b) passes through an opening toward the first hole, and (c) is between the base portion and the second conduit.
[0095] Example 25.1. The system according to Example 15, wherein the link portion includes at least one of a cord, a cable, a line, a string, a rod, a wire, a bar, a coil, or a combination thereof.
[0096] Example 26 The system according to any one of Examples 25 to 25.1, wherein the most distal edge of the second conduit is chamfered.
[0097] Example 27 The system according to any one of Examples 25 to 25.1, wherein the most distal edge of the second conduit includes a first portion and a second portion. The first portion is more distal than the second portion.
[0098] Example 28 The system according to Example 17, wherein the first and second portions form opposing edges of a hole. The hole has an opening defined by the first and second portions.
[0099] Example 29 The system according to any one of Examples 25 to 28, comprising a second elastic metal member. The second conduit includes the second elastic metal member. The link portion is coupled to the second elastic metal member, and the base portion includes a second hole in a side wall of the base portion. The second elastic metal member is (a) contained within the second hole, (b) passes through an opening toward the second hole, and (c) is between the base portion and the second conduit.
[0100] Example 30 The system according to Example 29, wherein a through hole passes through the base portion and connects the first hole to the second hole.
[0101] Example 30.1 The system according to any one of Examples 28 to 29, wherein most of the first elastic metal member is contained in a plane. Most of the second elastic metal member is contained in a plane.
[0102] Example 30.2 The system according to Example 30.1, wherein the link portion includes a major axis, and the plane is substantially parallel to the major axis of the link portion.
[0103] Example 30.3 The system according to any one of Examples 29 to 30.2, wherein each of the first and second elastic metal members is flattened.
[0104] Example 31 The system according to any one of Examples 25 to 30.3, wherein the first hole has a through hole passing through the base portion.
[0105] Example 32 The system according to any one of Examples 25 to 31, wherein in a first orientation, the first elastic metal member is contained within the first hole, whereby the base portion and the SMP are fixed to the link portion. In a second orientation, the link portion and the first elastic metal member are pulled in a proximal direction, and in response to the first elastic metal member being discharged from the first hole, the base portion and the SMP are no longer fixed to the link portion.
[0106] Example 33 The system according to any of Examples 25 to 32, wherein the first elastic metal member comprises at least one of stainless steel, nickel titanium, or a combination thereof.
[0107] Example 35 The embodiment includes a system comprising an implant having an expandable plug element and a base portion. The expandable plug element and the base portion are permanently attached to each other. The system includes a link portion; a first elastic member; and a first conduit including the link portion. The link portion is coupled to the first elastic metal member; at least a portion of the base portion is between the expandable plug element and a portion of the first conduit; the base portion includes a first hole in a sidewall thereof; and the first elastic metal member is (a) contained within the first hole and (b) passes through an opening toward the first hole.
[0108] Example 35.1 The system according to Example 35, wherein the link portion comprises at least one of a cord, a cable, a line, a string, a rod, a wire, a bar, a coil, or a combination thereof.
[0109] Example 36 The system according to any of Examples 35 to 35.1, wherein the most distal edge of the first conduit is chamfered.
[0110] Example 37 The system according to any of Examples 35 to 35.1, wherein the most distal edge of the first conduit includes first and second portions; and the first portion is more distal than the second portion.
[0111] Example 38 The system according to Example 37, wherein the first and second portions form opposing edges of a hole; and the hole has an opening defined by the first and second portions.
[0112] Example 39 Comprising a second elastic metal member, with the link portion coupled to the second elastic metal member; the base portion including a second hole in a side wall of the base portion; the second elastic metal member being (a) contained within the second hole and (b) passing through an opening toward the second hole, the system according to any one of Examples 35 to 38.
[0113] Example 40 The system according to Example 39, wherein a through hole passes through the base portion and connects the first hole to the second hole.
[0114] Example 40.1 The system according to any one of Examples 38 to 39, wherein most of the first elastic metal member is contained in a plane. Most of the second elastic metal member is contained in a plane.
[0115] Example 40.2 The system according to Example 40.1, wherein the link portion includes a major axis. The plane is substantially parallel to the major axis of the link portion.
[0116] Example 40.3 The system according to any one of Examples 39 to 40.2, wherein each of the first and second elastic metal members is flattened.
[0117] Example 41 The system according to any one of Examples 35 to 40.3, wherein the first hole has a through hole passing through the base portion.
[0118] Example 42 In a first orientation, the first elastic metal member is contained within the first hole, whereby the base portion and the expandable plug element are fixed to the link portion, the system according to any one of Examples 35 to 41. In a second orientation, the link portion and the first elastic metal member are pulled in a proximal direction, and in response to the first elastic metal member being discharged from the first hole, the base portion and the expandable plug element are no longer fixed to the link portion.
[0119] Example 43 The system according to any one of Examples 35 to 42, wherein the first elastic metal member includes at least one of stainless steel, nickel titanium, or a combination thereof.
[0120] Example 1a The embodiment includes a system comprising an implant having an SMP (701) irreversibly coupled to a collar (702). The system comprises a distal actuator wire (703), a retention wire (704), a proximal actuator wire (705), and a shaft (706) coupling the distal actuator wire to the proximal actuator wire. The system further comprises a coil (707) (e.g., a stainless steel coil) that includes the distal actuator wire but not the retention wire. The system further comprises a first conduit (708) that is (a) releasably coupled to the collar and (b) includes the distal actuator wire and the retention wire but not the coil. The system comprises a second conduit (709) that is (a) releasably coupled to the collar and (b) has the distal actuator wire, the retention wire, and the coil. The collar has a channel (710), a first hole (711), and a second hole (712) located in the sidewall (713) of the collar. The distal actuator wire is (a) contained within the channel and (b) passes through the first hole but not the second hole. The retention wire is (a) contained within the channel and (b) passes through the first and second holes.
[0121] Adhesive bond 725 and solder bond 725 are shown in FIG. 7A but not in other figures for clarity. Wires 703, 704 may include stainless steel or the like.
[0122] Example 2a The system of Example 1a, wherein the shaft has a distal hole (714) that includes the distal actuator wire and a proximal hole (715) that includes the proximal actuator wire.
[0123] The holes in the shaft may include openings, gaps, cuffs, slots, grooves, through-holes (e.g., holes that completely cross an object such as a plug). The rod or shaft 706 may include stainless steel.
[0124] Example 3a The system of Example 2a, wherein the distal hole is slidably coupled to the distal actuator wire and the proximal hole is slidably coupled to the proximal actuator wire.
[0125] In an embodiment, only one of the distal or proximal holes is included in the system. Such a single hole need not necessarily be included in the proximal or distal region of the shaft or wire.
[0126] Example 4a The system of Example 3a, wherein the proximal portion (716) of the distal actuator wire is proximal to the distal hole and has an outer diameter larger than the inner diameter of the distal hole. The distal portion (717) of the proximal actuator wire is distal to the proximal hole and has an outer diameter larger than the inner diameter of the proximal hole.
[0127] Example 5a The system of Example 4a, wherein in the non - deployed configuration, the proximal portion of the distal actuator wire does not directly contact the distal hole of the shaft. In the deployed configuration, the proximal portion of the distal actuator wire directly contacts the distal hole of the shaft.
[0128] For example, FIG. 7D shows the non - deployed configuration and FIG. 7F shows the deployed configuration. In FIG. 7D, the proximal actuator wire can move freely without affecting the distal actuator wire. The distal actuator wire serves to relieve interference between the distal actuator wire and the retention wire.
[0129] FIG. 6 shows the problem that some embodiments described in this specification address. Such problems exist in many conventional single pull wire systems. Specifically, conduit 601 includes actuator wire 602 coupled to the implant of a medical device. The wire has a length (L) when not bent. Such bending may occur when passing through the patient's vasculature. However, the same wire may potentially become shorter when taking an outer radius (B), and the wire may be retracted by a distance "j" from its distal origin position (x = 0). Further, the same wire may potentially become longer when taking an inner radius (C), and the wire may be lengthened by a distance "k" from its distal origin position (x = 0). This varying distance may affect the accuracy and comfort level of the physician implanting the device, and this variation is reduced in embodiments where the bending can be "split" due to sliding cuffs 714, 715.
[0130] In an embodiment, wire 706 is omitted, and instead cuff / hole 714 is at the position of bead 717. This provides a two-wire embodiment (wires 703, 705) instead of a three-wire embodiment (wires 703, 705, 706).
[0131] Example 6a The system of Example 5a, wherein in a non-disposed configuration, the distal portion of the proximal actuator wire does not directly contact the proximal hole of the shaft. In a disposed configuration, the distal portion of the proximal actuator wire directly contacts the proximal hole of the shaft.
[0132] Example 7a The system of Example 6a, wherein the retention wire has a proximal protrusion (724) proximal to at least a portion of the coil. In a non-disposed configuration, the proximal protrusion does not directly contact the coil. In a disposed configuration, the proximal protrusion directly contacts the coil.
[0133] For example, in FIG. 7E, partial actuation / placement of the distal actuator wire has occurred. The actuator coil has not yet engaged the retention wire proximal tab 724. This coil / proximal tab engagement allows the physician to directly pull the retention wire and place the implant. This "direct actuation" provides the physician with additional control regarding implant placement.
[0134] In FIG. 7F, both actuator wires are in a fully tensioned state. By the balls 716, 717 interfering with the holes 714, 715, the physician can pull the four tensioned wires 703, 704, 705, 706 as a "composite" single wire system. The gap 723 between the cuffs occupies, for example, about 0.5 - 2% of the wire shortening (see radius B in FIG. 6).
[0135] In FIG. 7G, the actuator coil is engaged with the proximal tab 724, and the coil pulls the retention wire out of the collar hole 712, releasing the implant without further interference. Then in FIG. 7H, when fully actuated, the retention wire fully retracts into the lumen 709 (e.g., a polyimide shaft or lumen). Here, the separation collar 702 can be released from the system. The collar 702 may be radiopaque and may include platinum and / or iridium (e.g., an alloy or combination of platinum and / or iridium). Other embodiments may have a radiopaque collar including platinum and / or tungsten (e.g., an alloy or combination of platinum and / or tungsten). However, in other embodiments, the collar includes stainless steel. The conduit 708 may be radiopaque, may include platinum and / or iridium, and may function as a distal marker band.
[0136] Example 8a The system according to Example 2a, wherein the retention wire has a proximal protrusion (724) proximal to at least a portion of the coil.
[0137] Example 9a The system of Example 8a, wherein the retention wire has a distal protrusion (718) included in the second hole. The retention wire has a body, and both the proximal and distal protrusions of the retention wire extend radially away from the body of the retention wire.
[0138] Example 10a The system of Example 9a, wherein the distal protrusion of the retention wire has proximal and distal walls. The second conduit includes a long axis (720). The proximal wall of the distal protrusion of the retention wire is non - orthogonal to the long axis of the second conduit.
[0139] Example 11a The system of Example 2a, comprising a third conduit (719), with a portion of the third conduit being included within the first conduit but not within the second conduit, and another portion of the third conduit being included within the second conduit but not within the first conduit.
[0140] The conduit 719 may include polyimide and may function as an inner stopper.
[0141] Example 12a The system of Example 11a, wherein the third conduit is fixedly coupled to at least one of the first or second conduits. The third conduit is slidably coupled to both the first and second conduits.
[0142] Example 13a The system of Example 2a, comprising a void (722) between the collar and the first conduit. The second conduit includes a long axis (720). A first plane (721) is orthogonal to the long axis. The first plane intersects the first conduit, the second hole, the void, and the retention wire.
[0143] Example 14a The system of Example 13a, wherein the first plane intersects the distal actuator wire.
[0144] Example 15a The system of Example 13a, wherein the first conduit has a higher radiopacity than the second conduit.
[0145] Example 16a The system of Example 15a, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or combinations thereof.
[0146] Example 17a The system of Example 1a, wherein the distal actuator wire is in direct contact with the retention wire and applies a force to maintain the retention wire within the second aperture.
[0147] Example 18a The system of Example 1a, wherein the coil is non - releasably coupled to the distal actuation cord.
[0148] Example 19a The system of Example 1a, wherein in the non - deployed configuration, the shaft overlaps the distal actuator wire by a first overlap distance, and in the deployed configuration, the shaft overlaps the distal actuator wire by a second overlap distance that is less than the first overlap distance. The second conduit includes a long axis, and both the first and second overlap distances are parallel to the long axis.
[0149] Example 1b The embodiment includes a system comprising a medical implant having a channel, a first aperture, and a second aperture located in a sidewall of the medical implant. The system comprises a first wire, a second wire, a third wire, and a shaft or wire that couples the first wire to the third wire. The system comprises a coil that includes the first wire but not the second wire. The system comprises a first conduit that is (a) releasably coupled to the medical implant and (b) includes the first wire and the second wire but not the coil. The system comprises a second conduit that is (a) releasably coupled to the medical implant and (b) includes the first wire, the second wire, and the coil. The first wire is (a) contained within the channel and (b) passes through the first aperture but not through the second aperture. The second wire is (a) contained within the channel and (b) passes through both the first and second apertures.
[0150] As used herein, "wire" includes solid or hollow coupling agents such as cords, (solid or hollow) conduits, shafts, rods, etc., and has both rigidity (e.g., linear rigidity parallel to and along the long axis of the wire) and flexibility (e.g., radial flexibility orthogonal to the long axis of the wire) with respect to devices passing through the vasculature. Depending on the material used for the wire and the diameter of the wire described herein, the wire may have various flexibilities. The wires and / or shafts such as elements 703, 704, 705, 706 used herein may have equal or different flexibilities.
[0151] Embodiments may be used with SMP foam implants, but more generally may be used with medical implants.
[0152] Example 2b The system of Example 1b, wherein the shaft or wire has a distal aperture containing a first wire and a proximal aperture containing a third wire.
[0153] Example 3b The system of Example 2b, wherein the distal aperture is slidably coupled to the first wire and the proximal aperture is slidably coupled to the third wire.
[0154] Example 4b The system of Example 3b, wherein the proximal portion of the first wire is proximal to the distal aperture and has an outer diameter larger than the inner diameter of the distal aperture. The distal portion of the third wire is distal to the proximal aperture and has an outer diameter larger than the inner diameter of the proximal aperture.
[0155] Example 5b The system of Example 4b, wherein in the unconfigured configuration, the proximal portion of the first wire does not directly contact the distal aperture of the shaft or wire; and in the configured configuration, the proximal portion of the first wire directly contacts the distal aperture of the shaft or wire.
[0156] Example 6b The system of Example 5b, wherein in the unconfigured configuration, the distal portion of the third wire does not contact the shaft or the proximal bore of the wire directly. In the configured configuration, the distal portion of the third wire contacts the shaft or the proximal bore of the wire directly.
[0157] Example 7b The system of Example 6b, wherein the second wire has a proximal protrusion proximal to at least a portion of the coil. In the unconfigured configuration, the proximal protrusion does not contact the coil directly. In the configured configuration, the proximal protrusion contacts the coil directly.
[0158] Example 8b The system of Example 2b, wherein the second wire has a proximal protrusion proximal to at least a portion of the coil.
[0159] Example 9b The system of Example 8b, wherein the second wire has a distal protrusion included in the second bore. The second wire has a body, and both the proximal and distal protrusions of the second wire extend radially away from the body of the second wire.
[0160] Example 10b The system of Example 9b, wherein the distal protrusion of the second wire has a proximal wall and a distal wall. The second conduit includes a long axis. The proximal wall of the distal protrusion of the second wire is non-orthogonal to the long axis of the second conduit.
[0161] Example 11b The system of Example 2b, comprising a third conduit. A portion of the third conduit is included within the first conduit but not within the second conduit. Another portion of the third conduit is included within the second conduit but not within the first conduit.
[0162] Example 12b The system of Example 11b, wherein the third conduit is fixedly coupled to at least one of the first or second conduits. The third conduit is slidably coupled to both the first and second conduits.
[0163] Example 13b The system of Example 2b, comprising a void between the medical implant and the first conduit. The second conduit includes a long axis. The first plane is orthogonal to the long axis. The first plane intersects the first conduit, the second aperture, the void, and the second wire.
[0164] Example 14b The system of Example 13b, wherein the first plane intersects the first wire.
[0165] Example 15b The system of Example 13b, wherein the first conduit has a higher radiopacity than the second conduit.
[0166] Example 16b The system of Example 15b, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or combinations thereof.
[0167] Example 17b The system of Example 1b, wherein the first wire is in direct contact with the second wire and applies a force to maintain the second wire within the second aperture.
[0168] Example 18b The system of Example 1b, wherein the coil is irreversibly coupled to the distal activation cord.
[0169] Example 19b In a non-deployed configuration, the shaft or wire overlaps the first wire by a first overlap distance. In a deployed configuration, the shaft or wire overlaps the first wire by a second overlap distance that is less than the first overlap distance. The second conduit includes a long axis, and both the first and second overlap distances are parallel to the long axis.
[0170] Example 1c The embodiment includes a medical implant delivery system comprising a first wire, a second wire, a third wire, and a shaft or wire that couples the first wire to the third wire. The system includes a coil that includes the first wire but not the second wire, and a first conduit that is releasably coupled to a medical implant and that includes the first wire and the second wire but not the coil. The system further includes a second conduit that is releasably coupled to a medical implant and that includes the first wire, the second wire, and the coil. The first wire is configured to be (a) included within a channel of the medical implant, (b) pass through a first hole of the medical implant, but not pass through a second hole located in a sidewall of the medical implant. The channel couples the first hole to the second hole. The second wire is configured to be (a) included within the channel and (b) pass through the first and second holes.
[0171] The system may be fabricated, sold, and / or transported independently of any medical implant (whereby the implant may be later joined to the system).
[0172] Example 2c The system of Example 1c, wherein the shaft or wire has a distal hole that includes the first wire and a proximal hole that includes the third wire.
[0173] Example 3c The system of Example 2c, wherein the distal hole is slidably coupled to the first wire and the proximal hole is slidably coupled to the third wire.
[0174] Example 4c The system of Example 3c, wherein a proximal portion of the first wire is proximal to the distal hole and has an outer diameter that is larger than an inner diameter of the distal hole. A distal portion of the third wire is distal to the proximal hole and has an outer diameter that is larger than an inner diameter of the proximal hole.
[0175] Example 5c The system according to Example 4c, wherein in the non-deployed configuration, the proximal portion of the first wire does not directly contact the shaft or the distal hole of the wire; and in the deployed configuration, the proximal portion of the first wire directly contacts the shaft or the distal hole of the wire.
[0176] Example 6c The system according to Example 5c, wherein in the non-deployed configuration, the distal portion of the third wire does not directly contact the shaft or the proximal hole of the wire; and in the deployed configuration, the distal portion of the third wire directly contacts the shaft or the proximal hole of the wire.
[0177] Example 7c The system according to Example 6c, wherein the second wire has a proximal protrusion proximal to at least a portion of the coil; in the non-deployed configuration, the proximal protrusion does not directly contact the coil; and in the deployed configuration, the proximal protrusion directly contacts the coil.
[0178] Example 8c The system according to Example 2c, wherein the second wire has a proximal protrusion proximal to at least a portion of the coil.
[0179] Example 9c The system according to Example 8c, wherein the second wire has a distal protrusion that will be contained in a second hole; the second wire has a body, and both the proximal and distal protrusions of the second wire extend radially away from the body of the second wire.
[0180] Example 10c The system according to Example 9c, wherein the distal protrusion of the second wire has a proximal wall and a distal wall; the second conduit includes a long axis; and the proximal wall of the distal protrusion of the second wire is non-orthogonal to the long axis of the second conduit.
[0181] Example 11c The system according to Example 2c, further comprising a third conduit; a portion of the third conduit is contained within the first conduit but not within the second conduit; and another portion of the third conduit is contained within the second conduit but not within the first conduit.
[0182] Example 12c The system of Example 11c, wherein a third conduit is fixedly coupled to at least one of the first or second conduits. The third conduit is slidably coupled to both the first and second conduits.
[0183] Example 13c The system of Example 2c, comprising a void between a medical implant and a first conduit. The second conduit includes a long axis. A first plane is orthogonal to the long axis. The first plane intersects the first conduit, the void, and the second wire and is configured to intersect a second hole.
[0184] Example 14c The system of Example 13c, wherein a first plane intersects a first wire.
[0185] Example 15c The system of Example 13c, wherein a first conduit has a higher radiopacity than a second conduit.
[0186] Example 16c The system of Example 15c, wherein a first conduit includes at least one of platinum, iridium, tungsten, or a combination thereof.
[0187] Example 17c The system of Example 1c, wherein a first wire is in direct contact with a second wire and is configured to apply a force to maintain the second wire within a second hole.
[0188] Example 18c The system of Example 1c, wherein a coil is non - releasably coupled to a distal actuation cord.
[0189] Example 19c The system of Example 1c, wherein in the non-configured configuration, the shaft or wire overlaps the first wire by a first overlapping distance, and in the configured configuration, the shaft or wire overlaps the first wire by a second overlapping distance that is less than the first overlapping distance. The second conduit includes a long axis, and both the first and second overlapping distances are parallel to the long axis.
[0190] Example 1d Embodiments include a system comprising a medical implant having a channel, a first hole, and a second hole located in a sidewall of the medical implant. The system includes a first wire, a second wire, a third wire, and a shaft or wire coupling the first wire to the third wire. The system includes a first conduit (a) releasably coupled to the medical implant and (b) having the first wire and the second wire. The system includes a second conduit (a) releasably coupled to the medical implant and (b) having the first wire and the second wire. The first wire is (a) contained within the channel and (b) passes through the first hole but not through the second hole. The second wire is (a) contained within the channel and (b) passes through both the first and second holes.
[0191] Thus, not all embodiments include a coil. For example, the first wire may include protrusions, shoulders, lips, etc. that cooperate with other system elements to position the implant.
[0192] Example 2d The system of Example 1d, wherein the shaft or wire has a distal hole that includes the first wire and a proximal hole that includes the third wire.
[0193] Example 3d The system of Example 2d, wherein the distal hole is slidably coupled to the first wire and the proximal hole is slidably coupled to the third wire.
[0194] Example 4d The system of Example 3d, wherein the proximal portion of the first wire is proximal to the distal hole and has an outer diameter larger than the inner diameter of the distal hole. The distal portion of the third wire is distal to the proximal hole and has an outer diameter larger than the inner diameter of the proximal hole.
[0195] Example 5d The system of Example 4d, wherein in the non - deployed configuration, the proximal portion of the first wire does not directly contact the distal hole of the shaft or wire. In the deployed configuration, the proximal portion of the first wire directly contacts the distal hole of the shaft or wire.
[0196] Example 6d The system of Example 5d, wherein in the non - deployed configuration, the distal portion of the third wire does not directly contact the proximal hole of the shaft or wire. In the deployed configuration, the distal portion of the third wire directly contacts the proximal hole of the shaft or wire.
[0197] Example 7d The system of Example 6d, wherein the second wire has a proximal protrusion.
[0198] Example 8d The system of Example 2d, wherein the second wire has a proximal protrusion.
[0199] Example 9d The system of Example 8d, wherein the second wire has a distal protrusion included in the second hole. The second wire has a body, and both the proximal and distal protrusions of the second wire extend radially away from the body of the second wire.
[0200] Example 10d The system of Example 9d, wherein the distal protrusion of the second wire has proximal and distal walls. The second conduit includes a long axis. The proximal wall of the distal protrusion of the second wire is non - orthogonal to the long axis of the second conduit.
[0201] Example 11d The system according to Example 2d, comprising a third conduit. A portion of the third conduit is contained within the first conduit but not within the second conduit. Another portion of the third conduit is contained within the second conduit but not within the first conduit.
[0202] Example 12d The system according to Example 11d, wherein the third conduit is fixedly coupled to at least one of the first or second conduits. The third conduit is slidably coupled to both the first and second conduits.
[0203] Example 13d The system according to Example 2d, comprising a void between the medical implant and the first conduit. The second conduit includes a long axis; a first plane is orthogonal to the long axis. The first plane intersects the first conduit, the second aperture, the void, and the second wire.
[0204] Example 14d The system according to Example 13d, wherein the first plane intersects the first wire.
[0205] Example 15d The system according to Example 13d, wherein the first conduit has a higher radiopacity than the second conduit.
[0206] Example 16d The system according to Example 15d, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or a combination thereof.
[0207] Example 17d The system according to Example 1d, wherein the first wire is in direct contact with the second wire and applies a force to maintain the second wire within the second aperture.
[0208] Example 18d In a non-configured configuration, a shaft or wire overlaps a first wire by a first overlapping distance, the system of Example 1d. In a configured configuration, the shaft or wire overlaps the first wire by a second overlapping distance that is less than the first overlapping distance. The second conduit includes a long axis, and both the first and second overlapping distances are parallel to the long axis.
[0209] Example 1e A medical implant having a channel, a first hole, and a second hole located in a sidewall of the medical implant; a first wire, a second wire, a third wire, and a shaft or wire coupling the first wire to the third wire; a coil including the first wire but not including the second wire; a first conduit (a) releasably coupled to the medical implant and (b) including the first wire and the second wire but not including the coil; a second conduit (a) releasably coupled to the medical implant and (b) including the first wire, the second wire, and the coil; wherein the first wire (a) is included within the channel and (b) passes through the first hole but not through the second hole; and the second wire (a) is included within the channel and (b) passes through the first and second holes, the system.
[0210] Example 2e The system of Example 1e, wherein the shaft or wire has a distal hole including the first wire and a proximal hole including the third wire.
[0211] Example 3e The system of Example 2e, wherein the distal hole is slidably coupled to the first wire and the proximal hole is slidably coupled to the third wire.
[0212] Example 4e The system according to any one of Examples 2e to 3e, wherein a proximal portion of the first wire is proximal to the distal hole and has an outer diameter larger than an inner diameter of the distal hole; and a distal portion of the third wire is distal to the proximal hole and has an outer diameter larger than an inner diameter of the proximal hole.
[0213] Example 5e In the non-arrangement configuration, the proximal portion of the first wire does not directly contact the shaft or the distal hole of the wire; in the arrangement configuration, the proximal portion of the first wire directly contacts the shaft or the distal hole of the wire, the system according to any one of Examples 2e to 4e.
[0214] Example 6e In the non-arrangement configuration, the distal portion of the third wire does not directly contact the shaft or the proximal hole of the wire; in the arrangement configuration, the distal portion of the third wire directly contacts the shaft or the proximal hole of the wire, the system according to Example 5e.
[0215] Example 7e The second wire has a proximal protrusion proximal to at least a portion of the coil; in the non-arrangement configuration, the proximal protrusion does not directly contact the coil; in the arrangement configuration, the proximal protrusion directly contacts the coil, the system according to any one of Examples 5e to 6e.
[0216] Example 8e The second wire has a proximal protrusion proximal to at least a portion of the coil, the system according to any one of Examples 1e to 7e.
[0217] Example 9e The second wire has a distal protrusion included in the second hole; the second wire has a body, and both the proximal and distal protrusions of the second wire extend radially away from the body of the second wire, the system according to Example 8e.
[0218] Example 10e The distal protrusion of the second wire has proximal and distal walls; the second conduit includes a long axis; the proximal wall of the distal protrusion of the second wire is non-orthogonal to the long axis of the second conduit, the system according to any one of Examples 8e to 9e.
[0219] Example 11e A system according to any one of Examples 1e to 10e, comprising a third conduit, a part of the third conduit being contained within the first conduit but not within the second conduit; and another part of the third conduit being contained within the second conduit but not within the first conduit.
[0220] Example 12e A system according to Example 11e, wherein the third conduit is fixedly coupled to at least one of the first or second conduits; and the third conduit is slidably coupled to both the first and second conduits.
[0221] Example 13e A system according to any one of Examples 1e to 12e, comprising a void between the medical implant and the first conduit, the second conduit including a long axis; a first plane being orthogonal to the long axis; and the first plane intersecting the first conduit, the second aperture, the void, and the second wire.
[0222] Example 14e A system according to Example 13e, wherein the first plane intersects the first wire.
[0223] Example 15e A system according to any one of Examples 1e to 14e, wherein the first conduit has a higher radiopacity than the second conduit.
[0224] Example 16e A system according to Example 15e, wherein the first conduit includes at least one of platinum, iridium, tungsten, or combinations thereof.
[0225] Example 17e A system according to any one of Examples 1e to 16e, wherein the first wire is in direct contact with the second wire and applies a force to maintain the second wire within the second aperture.
[0226] Example 18e A system according to any one of Examples 1e to 17e, wherein the coil is non - releasably coupled to the distal actuation cord.
[0227] Example 19e In a non-configured configuration, a shaft or wire overlaps a first wire by a first overlap distance; in a configured configuration, the shaft or wire overlaps the first wire by a second overlap distance that is less than the first overlap distance; a second conduit includes a long axis, and both the first and second overlap distances are parallel to the long axis. The system according to any one of Examples 1e to 18e.
[0228] The foregoing description of embodiments of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. This description and the following claims include terms such as left, right, upper, lower, top, bottom, above, below, first, second, etc., which are used for illustrative purposes only and should not be construed as limiting. For example, terms specifying relative vertical positions refer to situations where the side of a substrate is the "upper" surface of that substrate; in fact, the substrate may be in any orientation, and thus the "upper" side of the substrate may be below the "lower" side in a standard ground reference frame and still be within the meaning of the term "upper". The term "on" as used herein (including in the claims), unless specifically stated otherwise, does not indicate that a first layer "on" a second layer is in direct and immediate contact with the second layer; a third layer or other structure may be present between the first and second layers on the first layer. Embodiments of the devices or articles described herein can be manufactured, used, or transported in several positions and orientations. Those skilled in the art will appreciate that many modifications and variations are possible in light of the above teachings. Those skilled in the art will recognize various equivalent combinations and alternatives of the various components shown in the figures. Accordingly, the scope of the present invention is intended to be limited not by this detailed description, but rather by the appended claims of this specification.
Claims
1. A medical implant having a channel, a first hole, and a second hole located in a sidewall of the medical implant; A distal actuator wire, a retention wire, a proximal actuator wire, and a shaft or wire coupling the distal actuator wire to the proximal actuator wire; A coil having the distal actuator wire but not having the retention wire; A first conduit (a) releasably coupled to the medical implant and (b) having the distal actuator wire and the retention wire but not having the coil; A second conduit (a) releasably coupled to the medical implant and (b) having the distal actuator wire, the retention wire, and the coil; Comprising: The distal actuator wire is (a) contained within the channel and (b) passes through the first hole but not through the second hole; The retention wire is (a) contained within the channel and (b) passes through the first and second holes, a system.
2. By pulling the proximal actuator wire, the distal actuator wire is pulled and withdrawn from the first hole via the shaft or wire, By pulling the distal actuator wire, via engagement of the coil and the retention wire, the retention wire is pulled and withdrawn from the first and second holes, and the medical implant is released from the first and second conduits, the system according to claim 1.
3. The shaft or wire has a distal hole containing the distal actuator wire and a proximal hole containing the proximal actuator wire, the system according to claim 1 or 2.
4. The distal hole is slidably coupled to the distal actuator wire, and the proximal hole is slidably coupled to the proximal actuator wire, the system according to claim 3.
5. A proximal portion of the distal actuator wire is proximal to the distal hole and has an outer diameter larger than an inner diameter of the distal hole; A distal portion of the proximal actuator wire is distal to the proximal hole and has an outer diameter larger than an inner diameter of the proximal hole, the system according to claim 3 or 4.
6. In the non-arranged configuration, the proximal portion of the distal actuator wire does not directly contact the distal hole of the shaft or wire; The system according to any one of claims 3 to 5, wherein in the arranged configuration, the proximal portion of the distal actuator wire directly contacts the distal hole of the shaft or wire.
7. In the non-arranged configuration, the distal portion of the proximal actuator wire does not directly contact the proximal hole of the shaft or wire; The system according to claim 6, wherein in the arranged configuration, the distal portion of the proximal actuator wire directly contacts the proximal hole of the shaft or wire.
8. The holding wire has a proximal protrusion proximal to at least a portion of the coil; In the non-arranged configuration, the proximal protrusion does not directly contact the coil; The system according to claim 6 or 7, wherein in the arranged configuration, the proximal protrusion directly contacts the coil.
9. The system according to any one of claims 1 to 7, wherein the holding wire has a proximal protrusion proximal to at least a portion of the coil.
10. The holding wire has a distal protrusion included in the second hole; The system according to claim 9, wherein the holding wire has a body, and both the proximal protrusion and the distal protrusion of the holding wire extend radially away from the body of the holding wire.
11. The distal protrusion of the holding wire includes a proximal wall and a distal wall; The second conduit has a long axis; The system according to claim 10, wherein the proximal wall of the distal protrusion of the holding wire is non-orthogonal to the long axis of the second conduit.
12. Comprising a third conduit, A portion of the third conduit is included in the first conduit but not in the second conduit; The system according to any one of claims 1 to 11, wherein another portion of the third conduit is included in the second conduit but not in the first conduit.
13. The system according to claim 12, wherein the third conduit is fixedly coupled to at least one of the first or the second conduit.
14. Providing a void between the medical implant and the first conduit, The second conduit has a long axis; A first plane is orthogonal to the long axis; The system according to any one of claims 1 to 13, wherein the first plane intersects the first conduit, the second hole, the cavity, and the holding wire.
15. The system according to claim 14, wherein the first plane intersects the distal actuator wire.
16. The system according to any one of claims 1 to 15, wherein the first conduit has a higher radiopacity than the second conduit.
17. The system according to claim 16, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or a combination thereof.
18. The system according to any one of claims 1 to 17, wherein the distal actuator wire is in direct contact with the holding wire and applies a force to maintain the holding wire within the second hole.
19. The system according to any one of claims 1 to 18, wherein the coil is irreversibly coupled to the distal actuator wire.
20. In a non-deployed configuration, the shaft or wire overlaps the distal actuator wire by a first overlapping distance; In a deployed configuration, the shaft or wire overlaps the distal actuator wire by a second overlapping distance that is less than the first overlapping distance; The system according to any one of claims 1 to 19, wherein the second conduit has a major axis, and both the first overlapping distance and the second overlapping distance are parallel to the major axis.
Citation Information
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