Mechanical separation system for transcatheter devices

Abstract

To provide mechanical release systems for implantable medical devices.SOLUTION: An embodiment includes a system that allows a transcatheter-delivered implant to be advanced and retracted when inside a catheter or delivery sheath, as well as after deployment from the catheter / sheath. The system includes a mechanism that allows the implant to be immediately released in the target location upon activation.SELECTED DRAWING: Figure 7A

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 Transcatheter Devices", the contents of which are incorporated herein by reference.

[0002] Embodiments of the present invention belong to the field of medical devices, particularly transcatheter devices.

Background Art

[0003] It is estimated that six million people in the United States suffer from severe symptoms of chronic venous insufficiency. Symptoms range from dramatic skin changes to painful refractory ulcers, which are often found in the lower extremities. Chronic venous insufficiency is caused by weakened venous valves that can no longer prevent retrograde flow in the peripheral veins that carry blood back to the heart, resulting in a sudden increase in venous pressure. This high venous pressure can lead to the formation of varicose veins and venous ulcers. The most common site treated for chronic venous insufficiency is the great saphenous vein. Previous treatment methods for manifestations of chronic venous insufficiency include manual compression, surgical ligation and stripping, sclerotherapy, and endovenous ablation of the great saphenous vein. Endovenous ablation has many drawbacks. Endovenous ablation causes patients to experience pain from either anesthetic injection or laser treatment. Furthermore, recanalization may occur because physicians must ablate the entire cross-section of the vein uniformly and control the pullback speed of the laser. Many other complications can result, including deep vein thrombosis, bruising, sensory disturbance, skin burns, bruising, thrombophlebitis, and nerve damage.

[0004] U.S. Patent Application 20190015108 describes an embodiment for selectively occluding a region of the vascular system that may be susceptible to complications from sustained blood flow using a polyurethane shape-memory polymer (SMP) foam. Due to the foam's morphology and chemical properties, it can be compressed, loaded into an inserter, and advanced through a catheter to the target region. Upon contact with circulating blood, the foam expands (for example, within 2, 4, 6, 8, or 10 minutes after contact with blood) to its original shape, completely occluding the vascular lumen. This procedure utilizes minimally invasive technology.

[0005] U.S. Patent Application 20190015108 further provides that embodiments may utilize several delivery mechanisms. One such mechanism is a core wire placed within the volume of a foam implant, with the implant crimped onto the core wire to generate friction between the implant and the core wire. This friction allows the device to retract and advance until the device is fully expanded within the lumen of the treatment vessel. Once the device is fully expanded, the friction is reduced sufficiently so that the core wire can retract through the volume of the device.

[0006] U.S. Patent Application 20190015108 describes an alternative delivery mechanism in which the device is simply advanced through the catheter using a guidewire or pusher mechanism until the device is completely ejected from the delivery catheter. The alternative delivery mechanism involves the proximal end of the device being attached to a pusher mechanism via an exposed stainless steel wire. Once the device is delivered to the target 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 explanation of the drawing]

[0007] Features and advantages of 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 drawings. Where appropriate, reference numerals are repeated between drawings to indicate corresponding or similar elements.

[0008] [Figure 1] This figure shows an embodiment of a mechanical release system. This embodiment includes an "S"-shaped curve of the wire interfering with the side wall hole on the implant side. This embodiment also shows radial interference with the pull wire.

[0009] [Figure 2A] This figure shows an embodiment of one stage of device placement. [Figure 2B] This figure shows an embodiment of one stage of device placement. [Figure 2C] This figure shows an embodiment of one stage of device placement.

[0010] [Figure 3A] This figure shows an embodiment of a distal push wire (having a proximal ball tip and a side wall hole on the implant side). [Figure 3B] This figure shows an embodiment of a pusher shaft (having a retaining pin (black circle) for holding the collar, and an internal leaf spring interference section, where the leaf spring interferes with the axial hole on the implant side). [Figure 3C] This figure shows an embodiment of a proximal implant collar (having a tapered collar with a through hole for fitting onto a retaining pin of a pusher shaft). [Figure 3D] This figure shows an embodiment of one stage of device placement. [Figure 3E] This figure shows an embodiment of one stage of device placement. [Figure 3F] This figure shows an embodiment of one stage of device placement. [Figure 3G] This figure shows an embodiment in one stage of device placement. [Figure 3H] FIG. 1 is a diagram showing an embodiment in one step of device placement.

[0011] [Figure 4A] FIG. 7 is a diagram showing an embodiment in one step of device placement. [Figure 4B] FIG. 10 is a diagram showing an embodiment in one step of device placement.

[0012] [Figure 5A] FIG. 16 is a diagram showing an embodiment in one step of device placement. [Figure 5B] FIG. 19 is a diagram showing an embodiment in one step of device placement. [Figure 5C] FIG. 22 is a diagram showing an embodiment in one step of device placement. [Figure 5D] FIG. 25 is a diagram showing an embodiment in one step of device placement.

[0013] [Figure 6] FIG. 31 is a diagram showing problems in a single pull wire system.

[0014] [Figure 7A] FIG. 37 is a diagram showing an embodiment in one step of device placement. [Figure 7B] FIG. 40 is a diagram showing an embodiment in one step of device placement. [Figure 7C] FIG. 43 is a diagram showing an embodiment in one step of device placement. [Figure 7D] FIG. 46 is a diagram showing an embodiment in one step of device placement. [Figure 7E] FIG. 49 is a diagram showing an embodiment in one step of device placement. [Figure 7F] FIG. 52 is a diagram showing an embodiment in one step of device placement. [Figure 7G] FIG. 55 is a diagram showing an embodiment in one step of device placement. [Figure 7H] FIG. 58 is a diagram showing an embodiment in one step of device placement. [Modes for carrying out the invention]

[0015] Here, we refer to drawings where similar structures may be provided with similar reference numerals. To more clearly illustrate the structures of various embodiments, the drawings included herein are schematic representations of the structures. Therefore, the actual appearance of the fabricated structures, for example in a micrograph, may look different, while still incorporating the claimed structure of the illustrated embodiment. Also, the drawings may show only structures useful for understanding the illustrated embodiment. To maintain clarity in the drawings, additional structures known in the art may not be included. "Embodiments," "various embodiments," etc., indicate that the embodiments described in this way may include certain features, structures, or characteristics, but not all embodiments necessarily include certain features, structures, or characteristics. Some embodiments may have some or all of the features described for other embodiments, or may not have any of these features. "First," "second," "third," etc., describe a common object and indicate that different instances of a similar object are being referred to. Such adjectives do not imply that the objects described in this way must be in a given order in time, space, rank, or any other way. "Connected" may indicate that multiple elements are in direct physical or electrical contact with each other, while "joined" may indicate that multiple elements are interlocked or interact with each other, but they may or may not be in direct physical or electrical contact. Expressions such as "having at least one of A and B" include having A, B, or A and B.

[0016] The embodiment includes a system capable of advancing and retracting a transcatheter-delivered implant while it is inside the catheter or delivery sheath, and after it has been positioned away from the catheter / sheath. The system includes a mechanism that allows for immediate release of the implant at the target position during operation. Thus, such a system has advantages over the aforementioned systems that rely, for example, on electrolysis as a release mechanism. Such advantages include faster release, tactile feedback to the user during release, and ease of manufacture.

[0017] The embodiment has the ability to advance and retract the transcatheter-delivered implant before delivery to the target site. Immediate separation of the implant then occurs as desired. This increases the safety and comfort of delivering and manipulating minimally invasive implants.

[0018] Some embodiments consist of a retaining fit between the implant and the delivery system during final assembly, thereby allowing the implant to be pushed and pulled until the physician attempts to release it. Such embodiments include means for removing the retaining fit, either by pulling out the delivery sheath or by pulling a release wire, thereby allowing the implant to be delivered immediately and effectively.

[0019] The embodiment may be used to deliver transcatheter medical implants and to allow manipulation of the device before release. An alternative use is to deliver any device via needle, sheath, catheter, arthroscopic procedure, or other means when space is limited. The embodiment may be used, for example, by vascular surgeons, radiologic oncologists, and cardiac surgeons.

[0020] The embodiment has increased tensile strength in the delivery system, which makes it easier to prevent premature separation, and the design of the interlocking components allows for more reliable separation. The embodiment maintains control of the implant in both compression and tension until the implant delivery is desired.

[0021] Example 1 Example 1 includes a system comprising an implant having a shape memory polymer (SMP) (101) and a collar (102). The system further comprises first (103) and second (104) wires 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) which is (a) coupled to the coil and (b) has the second wire. Conduit 106 may be a radiopaque band containing platinum and / or iridium (e.g., an alloy or combination of platinum and / or iridium). Other embodiments may have a radiopaque band containing platinum and / or tungsten (e.g., an alloy or combination of platinum and / or tungsten). The band may contain stainless steel or other material. The system further comprises a second conduit (107) which couples the first wire to the second wire. At least a portion of the collar is between the SMP and the coil. The collar is channel (108), the collar In the proximal region First hole (109), and collar side wall Penetrating It includes a second hole (110). The channel connects the first hole to the second hole. The channel may be a through hole in the collar. The second wire is (a) contained within the channel, (b) passes through the second side wall hole, and (c) lies between the collar and the first conduit.

[0022] For example, in Figure 1, the embodiment includes an implant comprising an SMP foam and a collar. 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-holding wire. The coil may include the first wire. A first conduit, such as a platinum / iridium, platinum / tungsten, or stainless steel band, (a) is coupled to the coil and (b) includes the second wire. A second conduit, such as a centralized hypotube, connects the first wire to the second wire. At least a portion of the collar is located between the SMP and the coil. The collar is a channel, the collar is In the proximal region First hole, and collar side wall Penetrating It includes a second hole. The channel connects 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) lies between the collar and the first conduit.

[0023] As used herein, "hypotube" may be considered broadly as a conduit. The conduit may contain metal, but is not limited to metal, and may contain polymers, etc. The conduit does not need to be a tube. The conduit used herein may be hollow or solid along part or all of its length. For example, the conduit may have a long axis, and the plane perpendicular to the long axis does not necessarily intersect the outer circumference of a continuous tube. For example, the slot may have a cross-sectional profile such as a "U" shape.

[0024] Example 2 The system as described in Example 1, wherein the second wire is contained within the first hole.

[0025] Example 3 The system according to Example 2, wherein the first plane (111) intersects the first conduit, the second wire, the collar, and the second hole. The first plane does not intersect the first hole.

[0026] For example, see "First Plane" in Figure 1.

[0027] Example 4 The system according to Example 3, wherein a second wire is connected between the first conduit and collar via a resistance fit (112). The resistance fit is removed when the first wire is moved proximal away from the collar. When the resistance fit is removed, the implant is positioned from the first conduit.

[0028] For the area of ​​"resistance fit," see, for example, Figures 2A, 2B, and 2C. The "resistance fit" provides sufficient resistance so that the physician can repeatedly move the entire system back and forth (proximal and distal) before the final placement of the implant, without prematurely disconnecting the implant from the delivery coil. However, if the physician holds the coil firmly but pulls the round wire link proximal, the resistance is overcome, and the retaining wire is pulled out of the collision area that causes the resistance fit. The circular area in Figure 1 shows one area of ​​resistance, while resistance may occur in other areas of the retaining wire, such as within the second bore.

[0029] Example 5 The embodiment includes a system comprising an implant having an SMP (501) and a collar (502). The system comprises first (503) and second (504) wires, a coil (506) containing the first wire, and a first conduit (507) which is (a) coupled to the coil and (b) has the second wire. The system comprises a second conduit (508) which connects the first wire to the second wire. At least a portion of the collar is located between the SMP and the coil. The collar has a first hole (509) in its side wall. The second wire is (a) contained within the first hole, (b) passing through the opening toward the first hole, and (c) located between the collar and the first conduit.

[0030] See, for example, Figure 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 bring the system to the center. The first hole may include a through hole. However, in some embodiments, the first hole does not necessarily have to pass through the collar. As shown in Figure 5, the second wire is (a) contained within the first hole, (b) passing through the opening toward the first hole, and (c) between the collar and the first conduit.

[0031] The coil 506 may contain polyimide. The wire 503 may contain stainless steel pull wire. The conduit 508 may contain a centralized hypotube. The wires 504 and 505 may contain flattened stainless steel or nitinol wire. The band 507 may contain a chamfered portion. The chamfered portion and retaining wire of the system push the implant forward and downward in the ground frame of Figure 4B. This causes the foam to move toward the vessel wall in some vessel embodiments (Figure 5D). In other words, the arrow pointing to the right simply represents distal movement, but when the implant moves distally, the chamfered system instead drives the implant downward. The holes 509 and 510 may contain drilled through holes in the collar. The collar 502 may be radiopaque and may contain platinum and / or iridium (e.g., an alloy or combination of platinum and / or iridium). Other embodiments may have a radiopaque collar containing platinum and / or tungsten (e.g., an alloy or combination of platinum and / or tungsten). The band may contain stainless steel or other materials. In another embodiment, the collar contains stainless steel.

[0032] Figures 5A–5D show embodiments that do not show the SMP foam in order to focus on the collar and the delivery system as a whole. The embodiments in Figures 5A–5D are similar to the embodiments in Figures 4A–4B. However, in Figures 5A–5D, the natural state of the retaining wire is linear. Figure 5A shows that the flattened wire is attached to the centered hypo tube by either soldering or welding. Figure 5B shows that there are several forces (compressive force 513, frictional force 514, retaining force 515) introduced into the assembly when the mounting joint is assembled. Figure 5B further shows the chamfered portion 516. Figure 5C shows that during operation, as the bent tip of the flattened wire moves away from the drilled through hole; the frictional force from the two flattened wires trying to return to their initial state accumulates in addition to the compressive force. The chamfered stainless steel band restricts the collar from following in the direction of being "pulled". Figure 5D shows that when separation occurs between the pull wire and the implant collar, a compressive force is applied to the implant collar, releasing the collar from its constraint.

[0033] Example 6 The system as described in Example 5, wherein the distal edge of the first conduit is chamfered.

[0034] The chamfered portion includes inclined edges, such as the edge shown in Figure 5.

[0035] Example 7 The system according to Example 5, wherein the most distal edge of the first conduit includes the first (511) and second (512) portions. The first portion is distal to the second portion.

[0036] For example, see Figure 4A relating to the first and second parts.

[0037] Example 8 The system according to Example 7, wherein the first and second parts form opposing edges of a hole. The hole has an opening defined by the first and second parts.

[0038] For example, the hole is the area from which a portion of the collar is last to be placed during the placement of the implant toward final implantation.

[0039] Example 9 A 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 connects 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) passing through the opening toward the second hole, and (c) 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 retaining wires. Some embodiments may include only one retaining wire, while others may include three, four, five, or more retaining wires.

[0041] Example 10 The system according to Example 9, wherein a through hole passes through the collar and connects the first hole to the second hole.

[0042] In some embodiments, the holes penetrate the entire collar, while in other embodiments, one or more holes may simply be indentations or recesses in a portion of the collar.

[0043] Example 10.1 The system described in Example 9, wherein the majority of the second wire is contained within the plane. The majority of the third wire is contained within the plane.

[0044] This configuration makes it easier to generate sufficient retention force to reduce or minimize the possibility of the implant detaching prematurely from the delivery coil before the physician can pull the pull wire.

[0045] Example 10.2 The system described in Example 10.1, wherein the first wire includes its major axis. The plane is substantially parallel to the major axis of the first wire.

[0046] Example 10.3 The system described in Example 9, wherein each of the second and third wires is flattened.

[0047] In some embodiments, flattening one or both of the second and third wires makes it easier to restrict the profile of the delivery system. For example, the maximum outer diameter (see Figure 5) may be smaller. For example, in embodiments, the wires have a non-circular cross-section. For example, using the X, Y, Z coordinate system in Figure 5, the wires 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 through which the collar passes.

[0049] Example 12 The system according to Example 9, wherein in the first orientation, the collar and SMP are fixed to the first wire by the inclusion of the second wire within the first hole. In the second orientation, the first and second wires are pulled proximal, and in response to the second wire being pulled out of the first hole, the collar and SMP are no longer fixed to the first wire.

[0050] In the embodiment shown in Figure 5, when the pull wire is pulled proximal to release the implant, some resistance exists between the second and third retaining wires and the collar. This resistance allows the implant itself to move proximal, pivoting around the first portion of the most distal edge toward the second portion of the most distal edge. As a result, the proximal portion of the collar moves proximal. When the retaining wires (second and third wires) are no longer pulling the collar proximal, as long as there is "release" of the foam or a surgeon or thrust, the foam is slightly propelled away from the "first portion of the most distal edge," possibly toward the vessel wall. In other words, the foam is not ejected distally (see Figure 5), but instead ejected toward the vessel wall, which immediately stops the foam's progression. Consequently, the foam does not shift significantly from where the physician positioned it before pulling the pull wire. In other words, by ensuring that the thrust of the foam is rapidly reduced by the adjacent vessel walls, the chamfered portion makes it easier to hold the foam in place when released.

[0051] Other embodiments may function in different ways. For example, in one embodiment, when the pull wire is pulled proximal to release the implant, there is some resistance between the second and third retaining wires and the collar. However, the first portion of the most distal edge may prevent the collar from moving proximal. Nevertheless, the collar still needs to be ejected from the coil / delivery system. To this end (see, for example, Figures 5A to 5D), when the retaining wire releases the collar, the retaining wire may "spring" back to its original state. When the retaining wire (or multiple wires) springs back to its original undeformed state, it pushes 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 released prematurely. In other words, to prevent the implant from being prematurely dislodged while the doctor moves the implant back and forth to find the final placement site, the retaining wire may provide both resistance (e.g., between the collar and the coil) and compressive force (e.g., the wire being pushed into the hole in the collar). The same wire that holds the collar in the delivery system to prevent premature placement may also facilitate the dislodgement of the collar from the delivery system due to deformation from their deformed state to their non-deformed state.

[0052] Some embodiments may include a chamfered portion in the first conduit, while other embodiments do not have such a requirement. A physician may prefer the non-chamfered option for one type of case (e.g., placement of foam in a cranial artery aneurysm) and the chamfered option for another type of case (e.g., placement of foam in a femoral vessel). The need for a chamfer may also depend on the protruding force generated by the retaining wire, if one is present. For example, if the protruding force is small, the chamfered option may not be necessary. In some embodiments, the retaining wire may not apply little or no protruding force to the implant. For example, in some embodiments, when the retaining wire is withdrawn, the amount of remaining frictional force applied to the collar by the delivery system may be very small, so that the blood that causes embolization in, for example, the SMP foam (or other embolization device) may generate sufficient resistance against the implant, thereby allowing the delivery system to be withdrawn without moving the implant from its desired implantation position. In some cases, such as when injecting foam into a cranial artery aneurysm, which may have thinner walls than peripheral arteries in the thigh (and be less resistant to embolic elements propelled by the delivery system), such low propulsion force may be desirable.

[0053] Example 13 The system according to Example 12, wherein the second wire is elastic.

[0054] For example, nitinol is considered to have "elastic properties."

[0055] Example 14 The system according to 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 according to Example 12, wherein the second wire has shape memory.

[0057] Shape memory refers to the ability of a material, such as nitinol, to deform at a certain temperature, retain that deformed shape when the external force is removed, and then return to its original non-deformed shape when heated above its "deformation temperature."

[0058] Example 14.2 The system according to Example 12, wherein the second wire is superelastic.

[0059] Superelasticity is the ability of a metal to undergo large deformations and immediately return to its original 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 more than 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 nonlinear; 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] The embodiments are not limited to the shapes of the retaining wires as seen in Figures 4A to 5D. For example, some embodiments include two wires that collectively form a "V" shape. The spacing between the wires may limit the force that causes the implant to protrude from the delivery system.

[0065] Example 14.7 The system according to Example 14.3, wherein the second wire has both a deformed and an undeformed state; the second wire is in the deformed state.

[0066] Example 14.8 The system according to Example 14.7, wherein in a deformed state, the second wire generates (a) a frictional force between the collar and the first conduit, and (b) a compressive force on the collar.

[0067] Example 14.90 The system according to Example 14.8, wherein the second and third wires transition from a deformed state to an undeformed state when transitioning from a first orientation to a second orientation. In response to the transition of the second and third wires from a deformed state to an undeformed state, the collar is propelled away from the first conduit.

[0068] Example 14.91 The system as described in Example 14.90, wherein the first wire includes its long axis. In response to the transition of the second and third wires from a deformed state to an undeformed state, the collar is propelled away from the first conduit in a direction that is nonparallel to the long axis of the first wire.

[0069] In the embodiment, when the retaining wires are pulled proximal, they pull the collar proximal. However, due to the chamfer, the implant is subjected to a rotational force around the distal edge of the chamfer. When the retaining wires spring back to their initial positions, they provide a pressing force that pushes the implant away from the delivery system at an angle that pushes the implant laterally, so as not to be 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 Figure 5D.

[0070] Example 15 Embodiments include a system comprising an implant, the SMP and the base portion being permanently attached to each other. The system comprises a link portion; a first elastic metal member; a first conduit including the link portion; and a second conduit (a) 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 lies between the SMP and a portion of the first conduit. The base portion includes a first hole in its side wall. The first elastic metal member (a) is contained within the first hole, (b) passes through an opening toward the first hole, and (c) lies between the base portion and the second conduit.

[0071] Therefore, not all embodiments are disclosed in Figure 5. For example, the "centralized hypo" tube may or may not be included in some embodiments.

[0072] Example 15.1 The system according to Example 15, wherein the link section includes at least one of a cord, cable, line, string, rod, wire, bar, coil, or combination thereof.

[0073] Example 16 The system as described in Example 15, wherein the distal edge of the second conduit is chamfered.

[0074] Example 17 The system according to Example 15, wherein the most distal edge of the second conduit includes the first and second portions. The first portion is distal to the second portion.

[0075] Example 18 The system according to Example 17, wherein the first and second parts form opposing edges of a hole. The hole has an opening defined by the first and second parts.

[0076] Example 19 A 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 its side wall. The second elastic metal member is (a) contained within the second hole, (b) passing through the opening toward the second hole, and (c) located 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 the majority of the first elastic metal member is contained in a plane. The majority of the second elastic metal member is contained in a plane.

[0079] Example 20.2 The system described in Example 20.1, wherein the link section includes a major axis. The plane is substantially parallel to the major axis of the link section.

[0080] Example 20.3 The system according to Example 19, wherein each of the first and second elastic metal members is planar.

[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 The system according to Example 19, wherein in a first orientation, the base and SMP are fixed to the link portion by the inclusion of a first elastic metal member in a first hole. In a second orientation, the link portion and the first elastic metal member are pulled proximal, and in response to the first elastic metal member being ejected from the first hole, the base and 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 is superelastic.

[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 nonlinear. 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 collar 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 The system according to Example 24.7, wherein in a deformed state, the first elastic member generates (a) a frictional force between the base and the second conduit, and (b) a compressive force on the base.

[0092] Example 24.90 The system according to Example 24.8, wherein the first and second elastic members transition from a deformed state to a non-deformed state when transitioning from a first orientation to a second orientation. In response to the transition of the first and second elastic members from a deformed state to a non-deformed 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 a long axis. In response to the transition of the first and second elastic members from a deformed state to a non-deformed state, the base portion is propelled away from the second conduit in a direction that is non-parallel to the long axis of the link portion.

[0094] Example 25 Embodiments include 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 comprises 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, and at least a portion of the base portion lies between the SMP and a portion of the first conduit. The base portion includes a first hole in its side wall. The first elastic metal member is (a) contained within the first hole, (b) passing through an opening toward the first hole, and (c) located between the base portion and the second conduit.

[0095] Example 25.1 The system according to Example 15, wherein the link section includes at least one of a cord, cable, line, string, rod, wire, bar, coil, or combination thereof.

[0096] Example 26 The system according to any one of Examples 25 to 25.1, wherein the 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 the first and second portions. The first portion is distal to the second portion.

[0098] Example 28 The system according to Example 17, wherein the first and second parts form opposing edges of a hole. The hole has an opening defined by the first and second parts.

[0099] Example 29 A 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 the side wall of the base portion. The second elastic metal member is (a) contained within the second hole, (b) passing through the opening toward the second hole, and (c) located 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 the majority of the first elastic metal member is contained in a plane. The majority 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 planarized.

[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 base portion and SMP are fixed to the link portion by the inclusion of a first elastic metal member in a first hole. In a second orientation, the link portion and the first elastic metal member are pulled proximal, and in response to the first elastic metal member being ejected from the first hole, the base portion and SMP are no longer fixed to the link portion.

[0106] Example 33 The system according to any one of Examples 25 to 32, wherein the first elastic metal member includes at least one of stainless steel, nickel-titanium, or a combination thereof.

[0107] Example 35 Embodiments include a system comprising an implant having an expandable embolic element and a base. The expandable embolic element and the base are permanently attached to each other. The system includes a link; a first elastic member; and a first conduit containing the link. The link is coupled to the first elastic metal member; at least a portion of the base lies between the expandable embolic element and a portion of the first conduit; the base includes a first hole in its side wall; 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 includes at least one of a cord, cable, line, string, rod, wire, bar, coil, or combination thereof.

[0109] Example 36 The system according to any one of Examples 35 to 35.1, wherein the distal edge of the first conduit is chamfered.

[0110] Example 37 The system according to any one of Examples 35 to 35.1, wherein the most distal edge of the first conduit includes first and second portions; the first portion is distal to the second portion.

[0111] Example 38 The system according to Example 37, wherein the first and second parts form opposing edges of a hole; and the hole has an opening defined by the first and second parts.

[0112] Example 39 A system according to any one of Examples 35 to 38, comprising a second elastic metal member, wherein a link portion is coupled to the second elastic metal member; a base portion includes a second hole in the side wall of the base portion; and the second elastic metal member (a) is contained within the second hole and (b) passes through an opening toward the second hole.

[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 the majority of the first elastic metal member is contained in a plane. The majority of the second elastic metal member is contained in a plane.

[0115] Example 40.2 The system described in Example 40.1, wherein the link section includes a major axis. The plane is substantially parallel to the major axis of the link section.

[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 planarized.

[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 The system according to any one of Examples 35 to 41, wherein in a first orientation, the base portion and the expandable embolic element are fixed to the link portion by the inclusion of a first elastic metal member in a first bore. In a second orientation, the link portion and the first elastic metal member are pulled proximal, and in response to the first elastic metal member being ejected from the first bore, the base portion and the expandable embolic 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 Embodiments include a system comprising an implant having an SMP (701) irrevocably coupled to a collar (702). The system comprises a distal actuator wire (703), a retaining 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) including the distal actuator wire but not the retaining wire. The system further comprises a first conduit (708) (a) revocably coupled to the collar and (b) including the distal actuator wire and retaining wire but not the coil. The system comprises a second conduit (709) (a) revocably coupled to the collar and (b) having the distal actuator wire, retaining wire, and coil. The collar has a channel (710), a first hole (711), and a second hole (712) located in the side wall (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 retaining wire is (a) contained within the channel and (b) passes through the first and second holes.

[0121] Adhesive bonding 725 and soldering bonding 725 are shown in Figure 7A, but are not shown in other figures for clarity. Wires 703 and 704 may include stainless steel or the like.

[0122] Example 2a The system according to Example 1a, wherein the shaft has a distal hole (714) containing a distal actuator wire and a proximal hole (715) containing a proximal actuator wire.

[0123] The shaft bore may include openings, gaps, cuffs, slots, grooves, and through holes (e.g., holes that completely pass through an object such as a plug). The rod or shaft 706 may be made of stainless steel.

[0124] Example 3a The system according to Example 2a, wherein the distal bore is slidably coupled to the distal actuator wire and the proximal bore is slidably coupled to the proximal actuator wire.

[0125] In this embodiment, only one of the distal or proximal holes is included in the system. Such a single hole does not necessarily have to be located in the proximal or distal region of the shaft or wire.

[0126] Example 4a The system according to Example 3a, wherein the proximal portion (716) of the distal actuator wire is located 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 located distal to the proximal hole and has an outer diameter larger than the inner diameter of the proximal hole.

[0127] Example 5a In a non-arranged configuration, the proximal portion of the distal actuator wire does not directly contact the distal hole of the shaft, as described in Example 4a. In an arranged configuration, the proximal portion of the distal actuator wire directly contacts the distal hole of the shaft.

[0128] For example, Figure 7D shows a non-arranged configuration, and Figure 7F shows an arranged configuration. In Figure 7D, the proximal actuator wire can move freely without affecting the distal actuator wire. The distal actuator wire plays a role in mitigating interference between the distal actuator wire and the retaining wire.

[0129] Figure 6 illustrates a problem addressed by several embodiments described herein. Such problems exist in many conventional single-pull wire systems. Specifically, the conduit 601 includes an actuator wire 602 coupled to an implant of a medical device. The wire has a length (L) when not bent. Such bending may occur as it passes through the patient's vascular system. However, the same wire may potentially become shorter if it takes an outer radius (B), causing it to retract by a distance "j" from its distal origin (x=0). Furthermore, the same wire may potentially become longer if it takes an inner radius (C), causing it to lengthen by a distance "k" from its distal origin (x=0). This fluctuating distance can affect the precision and comfort level of the physician implanting the device, and this fluctuation is mitigated in embodiments where the bending can be "divided" by sliding cuffs 714, 715.

[0130] In this embodiment, wire 706 is omitted, and instead a cuff / hole 714 is located at the position of the bead 717. This provides a two-wire embodiment (wires 703, 705) instead of a three-wire embodiment (wires 703, 705, 706).

[0131] Example 6a In a non-arranged configuration, the distal portion of the proximal actuator wire does not directly contact the proximal bore of the shaft, as described in Example 5a. In an arranged configuration, the distal portion of the proximal actuator wire directly contacts the proximal bore of the shaft.

[0132] Example 7a The system according to Example 6a, wherein the retaining wire has a proximal projection (724) located near at least a portion of the coil. In the non-arranged configuration, the proximal projection does not directly contact the coil. In the arranged configuration, the proximal projection directly contacts the coil.

[0133] For example, in Figure 7E, partial actuation / positioning of the distal actuator wire is occurring. The actuator coil has not yet engaged with the retaining wire proximal tab 724. This coil / proximal tab engagement allows the physician to directly pull the retaining wire and position the implant. This "direct actuation" gives the physician further control over implant placement.

[0134] In Figure 7F, both actuator wires are in a fully tensed state. By balls 716, 717 interfering with holes 714, 715, the physician can pull the four tensed wires 703, 704, 705, 706 as a "composite" single wire system. The gap 723 between the cuffs accounts for, for example, about 0.5–2% of the wire shortening (see radius B in Figure 6).

[0135] In Figure 7G, the actuator coil is engaged with the proximal tab 724, and the coil pulls the retaining wire out of the collar hole 712, releasing the implant without further interference. Then, in Figure 7H, when fully actuated, the retaining wire retracts completely into the lumen 709 (e.g., polyimide shaft or lumen). At this point, the isolation collar 702 can be released from the system. The collar 702 may be radiopaque and may contain platinum and / or iridium (e.g., an alloy or combination of platinum and / or iridium). Other embodiments may have a radiopaque collar containing platinum and / or tungsten (e.g., an alloy or combination of platinum and / or tungsten). However, in other embodiments, the collar may contain stainless steel. The conduit 708 may be radiopaque and may contain platinum and / or iridium, and may function as a distal marker band.

[0136] Example 8a The system according to Example 2a, wherein the retaining wire has a proximal projection (724) located near at least a portion of the coil.

[0137] Example 9a The system according to Example 8a, wherein the retaining wire has a distal projection (718) contained within a second hole. The retaining wire has a body, and both the proximal and distal projections of the retaining wire extend radially away from the body of the retaining wire.

[0138] Example 10a The system according to Example 9a, wherein the distal projection of the retaining wire has proximal and distal walls. The second conduit includes a long axis (720). The proximal wall of the distal projection of the retaining wire is non-orthogonal to the long axis of the second conduit.

[0139] Example 11a The system according to Example 2a, further comprising a third conduit (719), wherein 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.

[0140] The conduit 719 may contain polyimide and may function as an internal stopper.

[0141] Example 12a The system according to 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 according to Example 2a, comprising a void (722) between the collar and the first conduit. The second conduit includes a long axis (720). The first plane (721) is perpendicular to the long axis. The first plane intersects the first conduit, the second hole, the void, and the retaining wire.

[0143] Example 14a The system as described in Example 13a, wherein the first plane intersects the distal actuator wire.

[0144] Example 15a The system according to Example 13a, wherein the first conduit has higher radiopaqueness than the second conduit.

[0145] Example 16a The system according to Example 15a, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or a combination thereof.

[0146] Example 17a The system according to Example 1a, wherein the distal actuator wire is in direct contact with the retaining wire and applies a force to maintain the retaining wire within the second hole.

[0147] Example 18a The system according to Example 1a, wherein the coil is irremovably coupled to the distal actuation cord.

[0148] Example 19a The system according to Example 1a, in a non-arranged configuration, the shaft overlaps the distal actuator wire by a first overlap distance. In an arranged configuration, the shaft overlaps the distal actuator wire by a second overlap distance less than the first overlap distance. The second conduit includes the long axis, and both the first and second overlap distances are parallel to the long axis.

[0149] Example 1b Embodiments include a system comprising a medical implant having a channel, a first hole, and a second hole located in the side wall of the medical implant. The system comprises a first wire, a second wire, a third wire, and a shaft or wire connecting the first wire to the third wire. The system comprises a coil including the first wire but not the second wire. The system comprises a first conduit (a) releasably coupled to the medical implant and (b) including the first wire and the second wire but not the coil. The system comprises a second conduit (a) releasably coupled to the medical implant and (b) including the first wire, the second wire, and the coil. The first wire (a) is contained within the channel and (b) passes through the first hole but not the second hole. The second wire (a) is contained within the channel and (b) passes through the first and second holes.

[0150] As used herein, “wire” includes a (solid or hollow) binding agent such as a cord, (solid or hollow) conduit, shaft, or rod, and has both rigidity (e.g., linear rigidity parallel to and along the long axis of the wire) and flexibility (e.g., radial flexibility perpendicular to the long axis of the wire) with respect to a device passing through a vascular system. Depending on the material used for the wire and the diameter of the wire as described herein, the wire may have a variety of flexibility. Wires and / or shafts such as elements 703, 704, 705, 706 as used herein may have equal or different flexibility.

[0151] The embodiment may be used with SMP foam implants, but more generally, it may be used with medical implants.

[0152] Example 2b The system according to Example 1b, wherein the shaft or wire has a distal hole containing a first wire and a proximal hole containing a third wire.

[0153] Example 3b The system according to Example 2b, wherein the distal bore is slidably coupled to a first wire and the proximal bore is slidably coupled to a third wire.

[0154] Example 4b The system according to Example 3b, wherein the proximal portion of the first wire is located 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 located distal to the proximal hole and has an outer diameter larger than the inner diameter of the proximal hole.

[0155] Example 5b The system according to Example 4b, wherein in a non-arranged configuration, the proximal portion of the first wire does not directly contact the shaft or the distal hole of the wire; and in an arranged configuration, the proximal portion of the first wire directly contacts the shaft or the distal hole of the wire.

[0156] Example 6b In a non-arranged configuration, the distal portion of the third wire does not directly contact the shaft or the proximal hole of the wire, as described in Example 5b. In an arranged configuration, the distal portion of the third wire directly contacts the shaft or the proximal hole of the wire.

[0157] Example 7b The system according to Example 6b, wherein the second wire has a proximal projection located near at least a portion of the coil. In the non-arranged configuration, the proximal projection does not directly contact the coil. In the arranged configuration, the proximal projection directly contacts the coil.

[0158] Example 8b The system according to Example 2b, wherein the second wire has a proximal projection located near at least a portion of the coil.

[0159] Example 9b The system according to Example 8b, wherein the second wire has a distal projection contained within the second hole. The second wire has a body, and both the proximal and distal projections of the second wire extend radially away from the body of the second wire.

[0160] Example 10b The system according to Example 9b, wherein the distal projection of the second wire has proximal and distal walls. The second conduit includes a long axis. The proximal wall of the distal projection of the second wire is non-orthogonal to the long axis of the second conduit.

[0161] Example 11b The system according to Example 2b, 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.

[0162] Example 12b The system according to 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 according to Example 2b, comprising a cavity between the medical implant and the first conduit. The second conduit includes a long axis. The first plane is perpendicular to the long axis. The first plane intersects the first conduit, the second hole, the cavity, and the second wire.

[0164] Example 14b The system as described in Example 13b, wherein the first plane intersects the first wire.

[0165] Example 15b The system according to Example 13b, wherein the first conduit has higher radiopaqueness than the second conduit.

[0166] Example 16b The system according to Example 15b, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or a combination thereof.

[0167] Example 17 The system according to Example 1b, wherein the first wire is in direct contact with the second wire and applies a force to hold the second wire in the second hole.

[0168] Example 18b The system as described in Example 1b, wherein the coil is inextricably coupled to the distal actuation cord.

[0169] Example 19b The system according to Example 1b, in a non-arranged configuration, the shaft or wire overlaps the first wire by a first overlap distance. In an arranged configuration, the shaft or wire overlaps the first wire by a second overlap distance which 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 Embodiments include a medical implant delivery system comprising a first wire, a second wire, a third wire, and a shaft or wire connecting the first wire to the third wire. The system further comprises a coil including the first wire but not the second wire, and a first conduit (a) releasably coupled to a medical implant and (b) including the first and second wires but not the coil. The system further comprises a second conduit (a) releasably coupled to a medical implant and (b) including the first wire, the second wire, and the coil. The first wire is configured (a) to be contained within a channel of the medical implant and (b) to pass through a first hole of the medical implant but not through a second hole located in the side wall of the medical implant. The channel connects the first hole to the second hole. The second wire is configured (a) to be contained within a channel and (b) to pass through the first and second holes.

[0171] The system may be manufactured, sold, and / or transported independently of any medical implant (the implant may then be joined to the system).

[0172] Example 2c The system according to Example 1c, wherein the shaft or wire has a distal hole containing a first wire and a proximal hole containing a third wire.

[0173] Example 3c The system according to Example 2c, wherein the distal bore is slidably coupled to a first wire and the proximal bore is slidably coupled to a third wire.

[0174] Example 4c The system according to Example 3c, wherein the proximal portion of the first wire is located 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 located distal to the proximal hole and has an outer diameter larger than the inner diameter of the proximal hole.

[0175] Example 5c In a non-arranged configuration, the proximal portion of the first wire does not directly contact the shaft or the distal hole of the wire, as described in Example 4c. In an arranged configuration, the proximal portion of the first wire directly contacts the shaft or the distal hole of the wire.

[0176] Example 6c In a non-arranged configuration, the distal portion of the third wire does not directly contact the shaft or the proximal hole of the wire, as described in Example 5c. In an arranged 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 projection located near at least a portion of the coil. In the non-arranged configuration, the proximal projection does not directly contact the coil. In the arranged configuration, the proximal projection directly contacts the coil.

[0178] Example 8c The system according to Example 2c, wherein the second wire has a proximal projection located near at least a portion of the coil.

[0179] Example 9c The system according to Example 8c, wherein the second wire has a distal projection that will be contained within the second hole. The second wire has a body, and both the proximal and distal projections 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 projection of the second wire has proximal and distal walls. The second conduit includes a long axis. The proximal wall of the distal projection of the second wire is non-orthogonal to the long axis of the second conduit.

[0181] Example 11c The system according to Example 2c, 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.

[0182] Example 12c The system according to Example 11c, 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.

[0183] Example 13c The system according to Example 2c, comprising a cavity between the medical implant and the first conduit. The second conduit includes a long axis. The first plane is perpendicular to the long axis. The first plane intersects the first conduit, the cavity, and the second wire, and is configured to intersect the second hole.

[0184] Example 14c The system described in Example 13c, wherein the first plane intersects the first wire.

[0185] Example 15c The system according to Example 13c, wherein the first conduit has higher radiopaqueness than the second conduit.

[0186] Example 16c The system according to Example 15c, wherein the first conduit includes at least one of platinum, iridium, tungsten, or a combination thereof.

[0187] Example 17c The system according to Example 1c, wherein the first wire is in direct contact with the second wire and is configured to apply a force to hold the second wire in the second hole.

[0188] Example 18c The system as described in Example 1c, wherein the coil is inextricably coupled to the distal actuation cord.

[0189] Example 19c The system according to Example 1c, in a non-arranged configuration, the shaft or wire overlaps the first wire by a first overlap distance. In an arranged configuration, the shaft or wire overlaps the first wire by a second overlap distance which 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.

[0190] Example 1d Embodiments include a system comprising a medical implant having a channel, a first hole, and a second hole located in the side wall of the medical implant. The system comprises a first wire, a second wire, a third wire, and a shaft or wire connecting the first wire to the third wire. The system comprises a first conduit (a) releasably coupled to the medical implant and (b) having the first and second wires. The system comprises a second conduit (a) releasably coupled to the medical implant and (b) having the first and second wires. The first wire (a) is contained within the channel and (b) passes through the first hole but not through the second hole. The second wire (a) is contained within the channel and (b) passes through the first and second holes.

[0191] Therefore, 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 according to Example 1d, wherein the shaft or wire has a distal hole containing a first wire and a proximal hole containing a third wire.

[0193] example 3d The system according to Example 2d, wherein the distal bore is slidably coupled to a first wire and the proximal bore is slidably coupled to a third wire.

[0194] Example 4d The system according to Example 3d, wherein the proximal portion of the first wire is located 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 located distal to the proximal hole and has an outer diameter larger than the inner diameter of the proximal hole.

[0195] Example 5d In a non-arranged configuration, the proximal portion of the first wire does not directly contact the shaft or the distal hole of the wire, as described in Example 4d. In an arranged configuration, the proximal portion of the first wire directly contacts the shaft or the distal hole of the wire.

[0196] Example 6d In a non-arranged configuration, the distal portion of the third wire does not directly contact the shaft or the proximal hole of the wire, as in the system described in Example 5d. In an arranged configuration, the distal portion of the third wire directly contacts the shaft or the proximal hole of the wire.

[0197] Example 7d The system according to Example 6d, wherein the second wire has a proximal projection.

[0198] Example 8d The system according to Example 2d, wherein the second wire has a proximal projection.

[0199] Example 9d The system according to Example 8d, wherein the second wire has a distal projection contained within the second hole. The second wire has a body, and both the proximal and distal projections of the second wire extend radially away from the body of the second wire.

[0200] Example 10d The system according to Example 9d, wherein the distal projection of the second wire has proximal and distal walls. The second conduit includes a long axis. The proximal wall of the distal projection 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 cavity between the medical implant and the first conduit. The second conduit includes a long axis; the first plane is perpendicular to the long axis. The first plane intersects the first conduit, the second hole, the cavity, and the second wire.

[0204] Example 14d The system described in Example 13d, wherein the first plane intersects the first wire.

[0205] Example 15d The system according to Example 13d, wherein the first conduit has higher radiopaqueness than the second conduit.

[0206] Example 16d The system according to Example 15d, wherein the first conduit includes at least one of platinum, iridium, tungsten, or a combination thereof.

[0207] Example 17d The system as described in Example 1d, wherein the first wire is in direct contact with the second wire and applies a force to hold the second wire in the second hole.

[0208] Example 18d The system according to Example 1d, in a non-arranged configuration, the shaft or wire overlaps the first wire by a first overlap distance. In an arranged configuration, the shaft or wire overlaps the first wire by a second overlap distance which 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.

[0209] Example 1e A medical implant having a channel, a first hole, and a second hole located in the side wall of the medical implant; a first wire, a second wire, a third wire, and a shaft or wire connecting the first wire to the third wire; a coil including the first wire but not 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 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 contained within the channel and (b) passes through the first hole but not through the second hole; and the second wire (a) is contained within the channel and (b) passes through the first and second holes.

[0210] Example 2e The system according to Example 1e, wherein the shaft or wire has a distal hole containing a first wire and a proximal hole containing a third wire.

[0211] Example 3e The system according to Example 2e, wherein the distal bore is slidably coupled to a first wire and the proximal bore is slidably coupled to a third wire.

[0212] Example 4e The system according to any one of Examples 2e to 3e, wherein the proximal portion of the first wire is located proximal to the distal hole and has an outer diameter larger than the inner diameter of the distal hole; and the distal portion of the third wire is located distal to the proximal hole and has an outer diameter larger than the inner diameter of the proximal hole.

[0213] Example 5e A system according to any one of Examples 2e to 4e, wherein in a non-arranged configuration, the proximal portion of the first wire does not directly contact the shaft or the distal hole of the wire; and in an arranged configuration, the proximal portion of the first wire directly contacts the shaft or the distal hole of the wire.

[0214] Example 6e The system according to Example 5e, wherein in a non-arranged configuration, the distal portion of the third wire does not directly contact the shaft or the proximal hole of the wire; and in an arranged configuration, the distal portion of the third wire directly contacts the shaft or the proximal hole of the wire.

[0215] Example 7e The system according to any one of Examples 5e to 6e, wherein the second wire has a proximal projection located near at least a portion of the coil; in a non-arranged configuration, the proximal projection does not directly contact the coil; and in an arranged configuration, the proximal projection directly contacts the coil.

[0216] Example 8e The system according to any one of Examples 1e to 7e, wherein the second wire has a proximal projection located near at least a portion of the coil.

[0217] Example 9e The system according to Example 8e, wherein the second wire has a distal projection contained within the second hole; the second wire has a body, and both the proximal and distal projections of the second wire extend radially away from the body of the second wire.

[0218] Example 10e The system according to any one of Examples 8e to 9e, wherein the distal projection of the second wire has proximal and distal walls; the second conduit includes a long axis; and the proximal wall of the distal projection of the second wire is non-orthogonal to the long axis of the second conduit.

[0219] Example 11e A system according to any one of Examples 1e to 10e, comprising a third conduit, wherein 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.

[0220] Example 12e The 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 cavity between a medical implant and a first conduit, wherein the second conduit includes a long axis; the first plane is perpendicular to the long axis; and the first plane intersects the first conduit, the second hole, the cavity, and the second wire.

[0222] Example 14e The system described in Example 13e, wherein the first plane intersects the first wire.

[0223] Example 15e The system according to any one of Examples 1e to 14e, wherein the first conduit has higher radiopaqueness than the second conduit.

[0224] Example 16e The system according to Example 15e, wherein the first conduit includes at least one of platinum, iridium, tungsten, or a combination thereof.

[0225] Example 17e The 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 hold the second wire in the second hole.

[0226] Example 18e The system according to any one of Examples 1e to 17e, wherein the coil is irremovably coupled to the distal actuation cord.

[0227] Example 19e A system according to any one of Examples 1e to 18e, wherein in a non-arranged configuration, a shaft or wire overlaps the first wire by a first overlap distance; in an arranged configuration, a shaft or wire overlaps the first wire by a second overlap distance less than the first overlap distance; and the second conduit includes a major axis, and both the first and second overlap distances are parallel to the major axis.

[0228] The foregoing description of embodiments of the present invention is presented for illustrative and explanatory purposes only. It is not intended to be comprehensive or to limit the invention to any specific form disclosed. This description and the following claims include terms such as left, right, top, bottom, up, down, superior, downward, first, second, etc., which are used solely for illustrative purposes and should not be construed as limiting. For example, a term specifying a relative vertical position refers to a situation where the side of a substrate is the “top” surface of that substrate; in fact, the substrate may be in any orientation, and therefore the “top” side of the substrate may be lower than the “bottom” side in a standard ground reference frame, and still fall within the meaning of the term “top.” When used herein (including in the claims), the term “~top” does not indicate that the first layer “above” the second layer is in direct contact with the second layer unless specifically stated so; a third layer or other structure may exist on the first layer between the first and second layers. Embodiments of devices or articles described herein can be manufactured, used, or transported in several positions and orientations. Those skilled in the art will understand, in view of the above teachings, that many modifications and variations are possible. Those skilled in the art will recognize various equivalent combinations and substitutes of the various components shown in the figures. Therefore, the scope of the invention is intended to be limited not by this detailed description, but rather by the claims appended herein. (Other possible items) [Item 1] A medical implant, wherein the medical implant has a channel, a first hole, and a second hole located on a side wall of the medical implant; A first wire, a second wire, a third wire, and a shaft or wire that couples the first wire to the third wire; A coil comprising the first wire but not the second wire; (a) a first conduit releasably coupled to the medical implant, (b) comprising the first wire and the second wire but not comprising the coil; (a) a second conduit releasably coupled to the medical implant, (b) comprising the first wire, the second wire, and the coil; comprising, the first wire (a) is contained within the channel, (b) passes through the first hole but does not pass through the second hole; the second wire (a) is contained within the channel, (b) passes through the first hole and the second hole. A system. [Item 2] The system according to Item 1, wherein the shaft or wire has a distal hole containing the first wire, and a proximal hole containing the third wire. [Item 3] The system according to Item 2, wherein the distal hole is slidably coupled to the first wire, and the proximal hole is slidably coupled to the third wire. [Item 4] a proximal portion of the first wire is located proximal to the distal hole, and has an outer diameter larger than an inner diameter of the distal hole; The system according to Item 2 or 3, wherein a distal portion of the third wire is located distal to the proximal hole, and has an outer diameter larger than an inner diameter of the proximal hole. [Item 5] In a non-deployment configuration, the proximal portion of the first wire does not directly contact the distal hole of the shaft or wire; The system according to any one of Items 2 to 4, wherein in a deployment configuration, the proximal portion of the first wire directly contacts the distal hole of the shaft or wire. [Item 6] In the aforementioned non-arranged configuration, the distal portion of the third wire does not directly contact the shaft or the proximal hole of the wire; The system according to item 5, wherein, in the arrangement configuration, the distal portion of the third wire is in direct contact with the proximal hole of the shaft or wire. [Item 7] The second wire has a proximal projection located near at least a portion of the coil; In the aforementioned non-arranged configuration, the proximal projection does not directly contact the coil; In the arrangement configuration described above, the proximal projection is in direct contact with the coil, as in the system described in item 5 or 6. [Item 8] The system according to any one of items 1 to 7, wherein the second wire has a proximal projection located near at least a portion of the coil. [Item 9] The second wire has a distal projection included in the second hole; The system according to item 8, wherein the second wire has a body, and both the proximal projection and the distal projection of the second wire extend radially away from the body of the second wire. [Item 10] The distal projection of the second wire includes the proximal wall and the distal wall; The second conduit has a long axis; The system according to item 8 or 9, wherein the proximal wall of the distal projection of the second wire is not perpendicular to the long axis of the second conduit. [Item 11] Equipped with a third conduit, A portion of the third conduit is contained within the first conduit but not within the second conduit; The system according to any one of items 1 to 10, wherein another portion of the third conduit is contained within the second conduit but not within the first conduit. [Item 12] The third conduit is fixedly connected to at least one of the first or second conduits; The system according to item 11, wherein the third conduit is slidably coupled to both the first and second conduits. [Item 13] A void is provided between the medical implant and the first conduit, The second conduit has a long axis; The first plane is perpendicular to the major axis; The system according to any one of items 1 to 12, wherein the first plane intersects the first conduit, the second hole, the cavity, and the second wire. [Item 14] The system according to item 13, wherein the first plane intersects the first wire. [Item 15] The system according to any one of items 1 to 14, wherein the first conduit has higher radiopaqueness than the second conduit. [Item 16] The system according to item 15, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or a combination thereof. [Item 17] The system according to any one of items 1 to 16, wherein the first wire is in direct contact with the second wire and applies a force to keep the second wire in the second hole. [Item 18] The system according to any one of items 1 to 17, wherein the coil is irremovably coupled to a distal actuation cord. [Item 19] In a non-arranged configuration, the shaft or wire overlaps the first wire by a first overlap distance; In the arrangement configuration, the shaft or wire overlaps the first wire by a second overlap distance that is less than the first overlap distance; The system according to any one of items 1 to 18, wherein the second conduit has a long axis, and both the first overlap distance and the second overlap distance are parallel to the long axis.

Claims

1. An implant including a shape memory polymer (SMP) and a collar, A first wire and a second wire, A first conduit including the first wire and the second wire, A second conduit including the first wire, At least a portion of the collar is located between the SMP and the first conduit, The collar includes a channel, a first hole in the proximal part of the collar, and a second hole penetrating the side wall of the collar. The channel connects the first hole to the second hole, The second wire is included in the channel, and in the first hole and the second hole. A system in which the first wire is included in the channel and the first hole, but not in the second hole.

2. The system according to claim 1, wherein the second wire is coupled between the first conduit and the first wire via a resistance fit.

3. The system according to claim 2, wherein the resistor is configured to be removed when the first wire moves in the proximal direction and away from the collar.

4. The system according to claim 3, wherein the implant is configured to separate from the first conduit when the resistance fitting is removed.

5. The second wire has a proximal projection located proximal to at least a portion of the second conduit, In the non-arranged configuration, the proximal projection is not in direct contact with the second conduit. In the arrangement configuration, the proximal projection is in direct contact with the second conduit. The system according to claim 1.

6. The system according to claim 5, wherein the second wire has a distal projection contained within the second hole.

7. The distal projection of the second wire has a proximal wall and a distal wall, The second conduit includes an axis extending from the proximal end of the second conduit to the distal end of the second conduit. The proximal wall of the distal projection of the second wire is not perpendicular to the axis of the second conduit. The system according to claim 6.

8. The second wire is configured to be pulled, and is configured to be pulled out from the first and second holes in response to the first wire being pulled in the proximal direction, so that when the first wire is pulled in the proximal direction, the second conduit comes into contact with the proximal projection and moves the proximal projection in the proximal direction. The system according to claim 6.

9. The system according to claim 5, wherein the first conduit has higher radiopaqueness than the second conduit.

10. The first wire is in direct contact with the second wire and applies a force to hold the second wire within the second hole. The system according to claim 5.

11. The system according to claim 5, wherein the second conduit is slidably coupled to the second wire.

12. The collar has a distal end opposite to its proximal end, The side wall of the collar connects the proximal end and the distal end of the collar to each other. The system according to claim 5.

Images