Mechanical detachment system for transcatheter devices
The mechanical detachment system for transcatheter devices addresses the inefficiencies and complications of existing methods by using a collar and wire mechanism for controlled implant deployment, ensuring safe and precise placement of shape memory polymer implants in treating chronic venous insufficiency.
Patent Information
- Application Number
- JP2025119019
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2020-08-21
- Filing Date
- 2025-07-15
- Publication Date
- 2025-10-15
AI Technical Summary
Existing transcatheter devices for treating 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 shape memory polymer implants are inefficient and prone to premature detachment.
A mechanical detachment system for transcatheter devices using an interference fit between the implant and delivery system, allowing for controlled advancement and immediate detachment at the target site, featuring a collar and wire mechanism that ensures reliable implant deployment without electrolysis, providing tactile feedback and ease of manufacture.
The system enables safer, more comfortable minimally invasive implant delivery with precise control over implant placement, reducing the risk of premature detachment and complications, and facilitating easier manipulation of the device during deployment.
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Figure 2025157383000001_ABST
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 August 21, 2020, entitled "Mechanical Detachment System for Transcatheter Devices," the contents of which are incorporated herein by reference.
[0002] FIELD OF THE INVENTION Embodiments of the present invention are in the field of medical devices, and in particular transcatheter devices. [Background technology]
[0003] An estimated 6 million people in the United States suffer from severe symptoms of chronic venous insufficiency. Symptoms range from dramatic skin changes to painful, refractory ulcers, often found 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 sudden increases in venous pressure. This hypertension can lead to the formation of varicose veins and venous ulcers. The most common area for treating 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. With endovenous ablation, patients experience pain from either anesthetic injections or laser treatment. Furthermore, physicians must uniformly ablate the entire cross-section of the vein and control the laser pullback speed, which can lead to recanalization. Many other complications may result, including deep vein thrombosis, bruising, loss of sensation, skin burns, bruising, thrombophlebitis, and nerve damage.
[0004] U.S. Patent Application 20190015108 describes embodiments using polyurethane shape memory polymer (SMP) foam to selectively occlude areas of the vasculature at risk of complications from persistent blood flow. The foam's morphology and chemistry allow it to be compressed, loaded into an introducer, and advanced through a catheter to the target area. Upon contact with circulating blood, the foam expands (e.g., within 2, 4, 6, 8, or 10 minutes after contacting blood) to its original shape, completely occluding the vascular lumen. The procedure utilizes minimally invasive techniques.
[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 create friction between the implant and the core wire. The friction allows for retraction and advancement of the device until the device is fully expanded within the lumen of the treatment vessel. Once the device is fully expanded, friction is reduced sufficiently to allow the core wire to retract through the volume of the device.
[0006] U.S. Patent Application 20190015108 describes another delivery mechanism in which the device is simply advanced through the catheter using a guidewire or pusher mechanism until the device is completely expelled from the delivery catheter. In another delivery mechanism, the proximal end of the device is attached to the pusher mechanism via an exposed stainless steel wire. Once the device is delivered to the target vessel, an electrical current is applied to the pusher mechanism, which causes electrolysis of the exposed stainless steel wire, effectively releasing the implant from the pusher mechanism. [Brief explanation of the drawings]
[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 considered appropriate, reference characters have been repeated among the drawings to indicate corresponding or analogous elements.
[0008] [Figure 1] 10 shows an embodiment of a mechanical release system that includes an "S" bend in the wire that interferes with the side wall hole on the implant side, and also radially interferes with the pull wire.
[0009] [Figure 2A] FIG. 1 illustrates an embodiment of a device deployment at one stage. [Figure 2B] FIG. 1 illustrates an embodiment of a device deployment at one stage. [Figure 2C] 1 illustrates an embodiment of a device deployment at one stage.
[0010] [Figure 3A] FIG. 10 shows an embodiment of a distal push wire (with a proximal ball tip and a sidewall hole on the implant side). [Figure 3B] FIG. 10 shows an embodiment of a pusher shaft having a retaining pin (black circle) for retaining the collar and an internal leaf spring interference portion where the leaf spring interferes with an axial hole on the implant side. [Figure 3C] 10A-10C show an embodiment of a proximal implant collar having a tapered collar with a through hole for fitting over a retaining pin on a pusher shaft. [Figure 3D] FIG. 1 illustrates an embodiment of a device deployment at one stage. [Figure 3E] FIG. 1 illustrates an embodiment of a device deployment at one stage. [Figure 3F] FIG. 1 illustrates an embodiment of a device deployment at one stage. [Figure 3G] 1 illustrates an embodiment of a device deployment at one stage. [Figure 3H] 1 illustrates an embodiment of a device deployment at one stage.
[0011] [Figure 4A] 1 illustrates an embodiment of a device deployment at one stage. [Figure 4B] 1 illustrates an embodiment of a device deployment at one stage.
[0012] [Figure 5A] 1 illustrates an embodiment of a device deployment at one stage. [Figure 5B] 1 illustrates an embodiment of a device deployment at one stage. [Figure 5C] 1 illustrates an embodiment of a device deployment at one stage. [Figure 5D] 1 illustrates an embodiment of a device deployment at one stage.
[0013] [Figure 6] FIG. 1 illustrates the problem with a single pull wire system.
[0014] [Figure 7A] 1 illustrates an embodiment of a device deployment at one stage. [Figure 7B] 1 illustrates an embodiment of a device deployment at one stage. [Figure 7C] 1 illustrates an embodiment of a device deployment at one stage. [Figure 7D] 1 illustrates an embodiment of a device deployment at one stage. [Figure 7E] 1 illustrates an embodiment of a device deployment at one stage. [Figure 7F] 1 illustrates an embodiment of a device deployment at one stage. [Figure 7G] 1 illustrates an embodiment of a device deployment at one stage. [Figure 7H] 1 illustrates an embodiment of a device deployment at one stage. DETAILED DESCRIPTION OF THE INVENTION
[0015] Reference is now made to the drawings, in which like structures may be provided with like reference designators. To more clearly illustrate the structure of various embodiments, the drawings included herein are schematic representations of the structures. Thus, the actual appearance of a fabricated structure, for example in a micrograph, may appear 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 of the drawings, additional structures known in the art may not be included. "Embodiments," "various embodiments," and the like indicate that the embodiments so described may include particular features, structures, or characteristics, but not all embodiments necessarily include the particular feature, structure, or characteristic. Some embodiments may have some, all, or none of the features described for other embodiments. "First," "second," "third," and the like describe a common object and indicate that different instances of the same object are being referenced. Such adjectives do not imply that the objects so described must be in a given order, either temporally, spatially, in ranking, or in any other manner. "Connected" may indicate that elements are in direct physical or electrical contact with each other, and "coupled" indicates that elements may interlock or interact with each other, but they may or may not be in direct physical or electrical contact. A phrase such as "comprises at least one of A and B" includes situations having A, B, or A and B.
[0016] Embodiments include systems capable of advancing and retracting a transcatheter-delivered implant while inside a catheter or delivery sheath, as well as after deployment from the catheter / sheath. The systems include mechanisms that, upon activation, can instantly release the implant at the target location. Such systems therefore have advantages over, for example, the systems described above that rely on electrolysis as the release mechanism. Such advantages include faster release, a tactile sensation to the user during release, and ease of manufacture.
[0017] Embodiments have the ability to advance and retract a transcatheter-delivered implant before delivery to a target site, followed by immediate detachment of the implant when desired, thereby increasing the safety and comfort of minimally invasive implant delivery and manipulation.
[0018] Some embodiments consist of an interference fit between the implant and delivery system during final assembly, allowing the implant to be pushed or pulled until the physician wishes to release the implant. Such embodiments include means to remove the interference fit by either withdrawing the delivery sheath or pulling the release wire, thereby effectively delivering the implant immediately.
[0019] Embodiments may be used to deliver transcatheter medical implants and allow manipulation of the device before release. An alternative use is to deliver any device via needle, sheath, catheter, arthroscopic procedure, or other method where space is limited. Embodiments may be used, for example, by vascular surgeons, interventional radiologists, and cardiac surgeons.
[0020] Embodiments have increased tensile strength in the delivery system, which can help prevent premature detachment, and the design of the interlocking components can result in more reliable detachment. 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 collar (102). The system further comprises first (103) and second (104) wires and a coil (105) comprising the first wire. Wire 104 can be a flat retention wire. Wire 103 can be a round wire. The system comprises a first conduit (106) (a) coupled to the coil and (b) comprising a second wire. Conduit 106 can be a radiopaque band comprising platinum and / or iridium (e.g., an alloy or combination of platinum and / or iridium). Other embodiments can include a radiopaque band comprising platinum and / or tungsten (e.g., an alloy or combination of platinum and / or tungsten). The band can comprise stainless steel or other materials. The system further comprises a second conduit (107) coupling the first wire to the second wire. At least a portion of the collar is between the SMP and the coil. The collar includes a channel (108), a first hole (109) in a first sidewall of the collar, and a second hole (110) in a second sidewall of the collar. The channel connects the first hole to the second hole. The channel may be a through-hole in the collar. A second wire (a) is contained within the channel, (b) passes through the second sidewall hole, and (c) is between the collar and the first conduit.
[0022] For example, in FIG. 1 , an embodiment includes an implant including an SMP foam and a collar. The entire implant is separate from the delivery coil. The delivery mechanism may include a first wire, such as a round wire, and a second wire, such as a flattened retaining 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 includes (b) the second wire. A second conduit, such as a centering hypotube, couples the first wire to the second wire. At least a portion of the collar is between the SMP and the coil. The collar includes a channel, a first hole in a first sidewall of the collar, and a second hole in a second sidewall of the collar. The channel couples the first hole to the second hole. The second wire is (a) contained within the channel, (b) passing through the second sidewall hole, and (c) between the collar and the first conduit.
[0023] As used herein, a "hypotube" may be broadly considered a conduit. A conduit may include, but is not limited to, metal, polymers, and the like. A conduit need not be a tube. A conduit, as used herein, may be hollow or solid along some or all of its length. For example, a conduit may include a longitudinal axis, and a plane perpendicular to the longitudinal axis may not necessarily intersect the circumference of a continuous tube. For example, a slot may have a cross-sectional profile, such as a "U" shape.
[0024] Example 2 10. The system of Example 1, wherein the second wire is contained within the first hole.
[0025] Example 3 3. The system of 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] See, for example, "First Plane" in Figure 1.
[0027] Example 4 The system of Example 3, wherein the second wire is coupled between the first conduit and the collar via a resistance fit (112). When the first wire is moved proximally away from the collar, the resistance fit is removed. When the resistance fit is removed, the implant is deployed from the first conduit.
[0028] See, e.g., Figures 2A, 2B, and 2C for the region of "resistance fit." 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 disconnecting the implant from the delivery coil. However, if the physician holds the coil steady but pulls the round wire link proximally, the resistance is overcome and the retention wire is pulled out of the region of impingement that creates the resistance fit. The circled region in Figure 1 shows one region of resistance, while resistance may occur in other regions of the retention wire, such as within the second hole.
[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) (a) coupled to the coil and (b) containing the second wire. The system also comprises a second conduit (508) coupling 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 hole (509) in a sidewall of the collar. The second wire is (a) contained within the first hole, (b) passing through an opening into the first hole, and (c) between the collar and the first conduit.
[0030] See, for example, 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 upon exposure to heat. The first wire may comprise a "pull wire," and the second wire may comprise a flattened wire. Embodiments may include a first conduit, such as a chamfered band. The second conduit may comprise a hypotube used to center the system. The first hole may comprise a through-hole. However, in some embodiments, the first hole does not necessarily pass through the collar. As shown in FIG. 5, the second wire (a) is contained within the first hole, (b) passes through an opening toward the first hole, and (c) is between the collar and the first conduit.
[0031] Coil 506 may comprise polyimide. Wire 503 may comprise a stainless steel pull wire. Conduit 508 may comprise a centering hypotube. Wires 504, 505 may comprise flattened stainless steel or nitinol wire. Band 507 may comprise a chamfer. The chamfer and retaining wire of the system urge the implant forward and downward in the ground frame of FIG. 4B. This causes the foam to move toward the vessel wall in some vascular embodiments (FIG. 5D). In other words, while the arrow pointing to the right is simply distal movement, as the implant moves distally, the chamfered system instead drives the implant downward. Holes 509, 510 may comprise drilled through-holes on the collar. Collar 502 may be radiopaque and may comprise platinum and / or iridium (e.g., an alloy or combination of platinum and / or iridium). Other embodiments may have a radiopaque collar 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. In another embodiment, the collar comprises stainless steel.
[0032] Figures 5A-5D show an embodiment that does not show the SMP foam to focus on the collar and the delivery system as a whole. The embodiment of Figures 5A-5D is similar to the embodiment of Figures 4A-4B. However, in Figures 5A-5D, the natural state of the retention wire is linear. Figure 5A shows that the flattened wire is attached to the centering hypotube by either soldering or welding. Figure 5B shows that when the attachment joint is assembled, there are several forces introduced into the assembly (compression force 513, friction force 514, retention force 515). Figure 5B also shows chamfer 516. Figure 5C shows that during actuation, as the bent tip of the flattened wire moves away from the drilled through-hole, frictional forces from the two flattened wires trying to return to their original state build up in addition to the compressive force. The chamfered stainless steel band restricts the collar from following the "pull" direction. FIG. 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 6. The system of Example 5, wherein the distal-most edge of the first conduit is chamfered.
[0034] A chamfer includes a beveled edge, such as the edge in FIG.
[0035] Example 7 6. The system of Example 5, wherein the distal-most edge of the first conduit comprises a first (511) and a second (512) portion, the first portion being more distal than the second portion.
[0036] See, for example, FIG. 4A for the first and second portions.
[0037] Example 8 8. The system of Example 7, wherein the first and second portions form opposing edges of the hole. The hole has an opening defined by the first and second portions.
[0038] For example, the hole is the area from which a portion of the collar will ultimately be placed during placement of the implant for final implantation.
[0039] Example 9 The system of any of Examples 5-8, further 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 a sidewall of the collar, wherein the third wire (a) is contained within the second hole, (b) passes through an opening toward 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. Some embodiments may include only one retention wire, while other embodiments may include three, four, five, or more retention wires.
[0041] Example 10 10. The system of Example 9, wherein a through hole passes through the collar and connects the first hole to the second hole.
[0042] For some embodiments, the holes extend through the entire portion of the collar, while in other embodiments, the hole or holes may simply be a depression or recess in a portion of the collar.
[0043] Example 10.1 The system of Example 9, wherein a majority of the second wire is contained in a plane. A majority of the third wire is contained in a plane.
[0044] This configuration tends to generate sufficient retention force to reduce or eliminate the likelihood of premature separation of the implant from the delivery coil before the physician can pull the pull wire.
[0045] Example 10.2 The system of Example 10.1, wherein the first wire comprises a long axis. The plane is substantially parallel to the long axis of the first wire.
[0046] Example 10.3 The system of 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 helps limit the profile of the delivery system. For example, the maximum outer diameter (see FIG. 5) may be smaller. For example, in embodiments, the wires are non-circular in cross section. For example, using the X, Y, Z coordinate system in FIG. 5, the wires may be wider in the Z direction than they are tall in the Y direction.
[0048] Example 11 6. The system of Example 5, wherein the first hole comprises a through hole passing through the collar.
[0049] Example 12 The system of Example 9, wherein in a first orientation, the collar and SMP are secured to the first wire by including a second wire within the first bore. In a second orientation, the first and second wires are pulled proximally, and in response to the second wire being withdrawn from the first bore, the collar and SMP are no longer secured to the first wire.
[0050] In the embodiment of FIG. 5, when the pull wire is pulled proximally to release the implant, there is some resistance between the second and third retention wires and the collar. This resistance allows the implant itself to move proximally, pivoting about 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 proximally. When the retention wires (second and third wires) no longer pull the collar proximally, 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 most distal edge," possibly toward the vessel wall. In other words, the foam is not ejected distally (see FIG. 5), but instead ejected toward the vessel wall, which immediately stops the foam's progression. As a result, the foam does not significantly deviate from where it was positioned before the physician pulled the pull wire. In other words, the chamfer helps hold the foam in place upon release by ensuring that the thrust of the foam is quickly reduced by the adjacent vessel wall.
[0051] Other embodiments may function differently. For example, in an embodiment, when the pull wire is pulled proximally to release the implant, there is some resistance between the second and third retention wires and the collar. However, a first portion of the distal-most edge may prevent the collar from moving proximally. The collar still needs to be ejected from the coil / delivery system. To do so (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, as the retention wire(s) spring back to its / their original, undeformed state, it / they push the collar out of the coil and first conduit. This solves the problem of how to position the collar while still ensuring that the implant is not prematurely released. In other words, the retention wires may provide both a resistive fit (e.g., between the collar and coil) and a compressive force (e.g., of the wire being pushed through the hole in the collar) to prevent premature release of the implant while the physician moves the implant back and forth to explore the final placement site. The same wires that hold the collar in the delivery system to prevent premature deployment can also facilitate pushing the collar out of the delivery system due to their deformation from a deformed state to an undeformed state.
[0052] Some embodiments may include a chamfer on the first conduit, while other embodiments do not have such a requirement. For example, a physician may prefer a non-chamfered option for one type of case (e.g., foam placement in a cranial aneurysm) and a chamfered option for another type of case (e.g., foam placement in a femoral vessel). The need for a chamfer may also depend on the ejection force generated by the retention wire, if any. For example, if the ejection force is small, a chamfered option may not be necessary. In some embodiments, the retention wire may exert little or no ejection force against the implant. For example, in some embodiments, when the retention wire is withdrawn, the amount of remaining frictional force exerted by the delivery system on the collar may be very small, such that blood embolizing within, for example, an SMP foam (or other embolic device) may generate sufficient resistance against the implant to allow the delivery system to be withdrawn without displacing the implant from its desired implanted position. In some cases, such low propulsion forces may be desirable, such as placing foam in cranial aneurysms, where the vessel walls may be thinner (and less resistant to embolic elements propelled from the delivery system) than the vessel walls of peripheral vessels in the thigh.
[0053] Example 13 13. The system of Example 12, wherein the second wire is elastic.
[0054] For example, nitinol is considered "elastic."
[0055] Example 14 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 is the ability of a material, such as 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 its "deformation temperature."
[0058] Example 14.2 The system of Example 12, wherein the second wire is superelastic.
[0059] Superelasticity is the ability of a metal to undergo large deformation and instantly return to its undeformed shape when the external load is removed. These materials can withstand high strains without plastic deformation. For example, Nitinol can be deformed 10 to 30 times more than ordinary metals and still return to its original shape.
[0060] Example 14.3 The system of Example 12, wherein the second wire has at least one of shape memory or superelasticity.
[0061] Example 14.4 The system of 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 of 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 of 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 retention wire shapes identified in Figures 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 ejects the implant from the delivery system.
[0065] Example 14.7 The system of Example 14.3, wherein the second wire has a deformed state and an undeformed state; and the second wire is in the deformed state.
[0066] Example 14.8 The system of Example 14.7, wherein in the deformed state, the second wire generates: (a) a friction force between the collar and the first conduit, and (b) a compressive force against the collar.
[0067] Example 14.90 The system of Example 14.8, wherein the second and third wires transition from a deformed state to an undeformed state when transitioning from the first orientation to the second orientation. In response to the second and third wires transitioning from the deformed state to the undeformed state, the collar is urged away from the first conduit.
[0068] Example 14.91 The system of Example 14.90, wherein the first wire includes a longitudinal axis. In response to the second and third wires transitioning from a deformed state to an undeformed state, the collar is urged away from the first conduit along a direction non-parallel to the longitudinal axis of the first wire.
[0069] In embodiments, when the retention wires are pulled proximally, they pull the collar proximally. However, due to the chamfer, the implant experiences a rotational force about the distal-most edge of the chamfer. When the retention wires rebound to their initial state, they provide a pushing force that pushes the implant laterally and away from the delivery system at an angle that pushes the implant out of direct alignment with the long axis of the coil and / or first wire. Note how the implant rotates downward in the lower depiction of Figure 5D.
[0070] Example 15 An embodiment includes a system comprising an implant including an SMP and a base portion, the SMP and base portion permanently attached to one another. The system includes a link portion; a first resilient metal member; a first conduit including the link portion; and a second conduit (a) coupled to the first conduit and (b) including the first resilient metal member. The link portion is coupled to the first resilient 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 resilient metal member is (a) contained within the first hole, (b) passing through an opening toward the first hole, and (c) between the base portion and the second conduit.
[0071] Thus, not all embodiments are disclosed in Figure 5. For example, a "centered hypo" tube may or may not be included in some embodiments.
[0072] Example 15.1 The system of Example 15, wherein the link 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.
[0073] Example 16 16. The system of Example 15, wherein the distal-most edge of the second conduit is beveled.
[0074] Example 17 16. The system of Example 15, wherein the distal-most edge of the second conduit comprises a first and a second portion, the first portion being more distal than the second portion.
[0075] Example 18 18. The system of Example 17, wherein the first and second portions form opposing edges of the hole. The hole has an opening defined by the first and second portions.
[0076] Example 19 The system of any of Examples 15-18, further comprising a second resilient metal member. The second conduit includes the second resilient metal member. The link is coupled to the second resilient metal member. The base includes a second hole in a sidewall of the base. The second resilient metal member (a) is contained within the second hole, (b) passes through the opening toward the second hole, and (c) is between the base and the second conduit.
[0077] Example 20 20. The system of 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 of Example 19, wherein a majority of the first resilient metal member is contained in a plane. A majority of the second resilient metal member is contained in a plane.
[0079] Example 20.2: The system of Example 20.1, wherein the link includes a major axis. The plane is substantially parallel to the major axis of the link.
[0080] Example 20.3 The system of Example 19, wherein each of the first and second resilient metal members is flattened.
[0081] Example 21 16. The system of Example 15, wherein the first hole comprises a through hole passing through the base portion.
[0082] Example 22 20. The system of Example 19, wherein in a first orientation, the base portion and SMP are secured to the link portion by including the first resilient metal member within the first aperture. In a second orientation, the link portion and first resilient metal member are pulled proximally, and in response to the first resilient metal member being ejected from the first aperture, the base portion and SMP are no longer secured to the link portion.
[0083] Example 23 23. The system of Example 22, wherein the first resilient metal member comprises at least one of stainless steel, nickel titanium, or a combination thereof.
[0084] Example 24.1 The system of Example 22, wherein the first elastic member has shape memory.
[0085] Example 24.2 The system of Example 22, wherein the first elastic member is superelastic.
[0086] Example 24.3 The system of Example 22, wherein the first elastic member has at least one of shape memory or superelasticity.
[0087] Example 24.4 The system of 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 of 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 of 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 into the first hole.
[0090] Example 24.7 The system of Example 24.3, wherein the first elastic member has a deformed state and an undeformed state. The first elastic member is in a deformed state.
[0091] Example 24.8. The system of Example 24.7, wherein in the deformed state, 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 The system of Example 24.8, wherein the first and second elastic members transition from a deformed state to an undeformed state when transitioning from the first orientation to the second orientation. In response to the first and second elastic members transitioning from the deformed state to the undeformed state, the base portion is urged away from the second conduit.
[0093] Example 24.91 The system of Example 24.90, wherein the link includes a longitudinal axis. In response to the first and second elastic members transitioning from a deformed state to an undeformed state, the base is urged away from the second conduit along a direction non-parallel to the longitudinal axis of the link.
[0094] Example 25 An embodiment includes a system comprising an implant having a shape memory polymer (SMP) and a base portion. The SMP and base portion are permanently attached to one another. The system includes a link portion; a first resilient metal member; a first conduit including the link portion; and a second conduit (a) coupled to the first conduit and (b) including the first resilient metal member. The link portion is coupled to the first resilient 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 resilient metal member is (a) contained within the first hole, (b) passing through an opening toward the first hole, and (c) between the base portion and the second conduit.
[0095] Example 25.1 The system of Example 15, wherein the link 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.
[0096] Example 26 The system of any of Examples 25 to 25.1, wherein the distal-most edge of the second conduit is chamfered.
[0097] Example 27 The system of any of Examples 25 to 25.1, wherein the distal-most edge of the second conduit comprises a first and a second portion, the first portion being more distal than the second portion.
[0098] Example 28 18. The system of Example 17, wherein the first and second portions form opposing edges of the hole. The hole has an opening defined by the first and second portions.
[0099] Example 29 The system of any of Examples 25-28, further comprising a second resilient metal member. The second conduit includes the second resilient metal member. The link is coupled to the second resilient metal member, and the base includes a second hole in a sidewall of the base. The second resilient metal member (a) is contained within the second hole, (b) passes through the opening toward the second hole, and (c) is between the base and the second conduit.
[0100] Example 30 30. The system of 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 of any of Examples 28-29, wherein a majority of the first resilient metal member is contained in a plane. A majority of the second resilient metal member is contained in a plane.
[0102] Example 30.2. The system of Example 30.1, wherein the link includes a major axis and the plane is substantially parallel to the major axis of the link.
[0103] Example 30.3 The system of any of Examples 29 to 30.2, wherein each of the first and second resilient metal members is flattened.
[0104] Example 31 The system of any of Examples 25 to 30.3, wherein the first hole comprises a through hole passing through the base portion.
[0105] Example 32 32. The system of any of Examples 25-31, wherein in a first orientation, the base portion and SMP are secured to the link portion by including the first resilient metal member within the first aperture. In a second orientation, the link portion and first resilient metal member are pulled proximally, and in response to the first resilient metal member being ejected from the first aperture, the base portion and SMP are no longer secured to the link portion.
[0106] Example 33 33. The system of any of Examples 25-32, wherein the first resilient metal member comprises at least one of stainless steel, nickel titanium, or a combination thereof.
[0107] Example 35 An embodiment includes a system comprising an implant having an expandable embolic element and a base portion. The expandable embolic element and the base portion are permanently attached to one another. The system includes a link portion; a first resilient member; and a first conduit including the link portion. The link portion is coupled to the first resilient metal member; at least a portion of the base portion is between the expandable embolic element and a portion of the first conduit; the base portion includes a first hole in a sidewall of the base portion; and the first resilient metal member (a) is contained within the first hole and (b) passes through an opening toward the first hole.
[0108] Example 35.1 The system of Example 35, wherein the link 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 of any of Examples 35 to 35.1, wherein the distal-most edge of the first conduit is chamfered.
[0110] Example 37 The system of any of Examples 35 to 35.1, wherein the distal-most edge of the first conduit comprises a first and a second portion; and the first portion is more distal than the second portion.
[0111] Example 38 38. The system of Example 37, wherein the first and second portions form opposing edges of the hole; and the hole has an opening defined by the first and second portions.
[0112] Example 39 39. The system of any of Examples 35 to 38, comprising a second resilient metal member, the link portion coupled to the second resilient metal member; the base portion including a second hole in a sidewall of the base portion; and the second resilient metal member (a) contained within the second hole and (b) passing through the opening toward the second hole.
[0113] Example 40 40. The system of 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 of any of Examples 38-39, wherein a majority of the first resilient metal member is contained in a plane. A majority of the second resilient metal member is contained in a plane.
[0115] Example 40.2: The system of Example 40.1, wherein the link includes a long axis. The plane is substantially parallel to the long axis of the link.
[0116] Example 40.3 The system of any of Examples 39 to 40.2, wherein each of the first and second resilient metal members is flattened.
[0117] Example 41 The system of any of Examples 35 to 40.3, wherein the first hole comprises a through hole passing through the base portion.
[0118] Example 42 42. The system of any of Examples 35-41, wherein in a first orientation, the base portion and the expandable embolic element are secured to the link portion by containing the first resilient metal member within the first aperture. In a second orientation, the link portion and the first resilient metal member are pulled proximally, and in response to the first resilient metal member being expelled from the first aperture, the base portion and the expandable embolic element are no longer secured to the link portion.
[0119] Example 43 43. The system of any of Examples 35-42, wherein the first resilient metal member comprises 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) non-releasably 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) comprising the distal actuator wire but not the retention wire. The system further comprises (a) a first conduit (708) releasably coupled to the collar and (b) a first conduit comprising the distal actuator wire and retention wire but not the coil. The system comprises (a) a second conduit (709) releasably coupled to the collar and (b) a second conduit having the distal actuator wire, retention wire, and coil. The collar has a channel (710), a first hole (711), and a second hole (712) located in a sidewall (713) of the collar. The distal actuator wire (a) is contained within the channel and (b) passes through the first hole but not the second hole, and the retention wire (a) is contained within the channel and (b) passes through the first and second holes.
[0121] Adhesive bonds 725 and solder joints 725 are shown in Figure 7A but not in other figures for clarity. Wires 703, 704 may comprise stainless steel or the like.
[0122] Example 2a The system of Example 1a, wherein the shaft has a distal bore (714) that contains a distal actuator wire and a proximal bore (715) that contains a proximal actuator wire.
[0123] The bore of the shaft may include an aperture, gap, cuff, slot, groove, through-hole (e.g., a hole that passes completely through an object such as a plug), etc. The rod or shaft 706 may comprise stainless steel.
[0124] Example 3a The system of Example 2a, wherein the distal hole is slidably coupled to a distal actuator wire and the proximal hole is slidably coupled to a proximal actuator wire.
[0125] In embodiments, only one of the distal or proximal holes is included in the system, and 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 a proximal portion (716) of the distal actuator wire is proximal to the distal bore and has an outer diameter larger than the inner diameter of the distal bore, and a distal portion (717) of the proximal actuator wire is distal to the proximal bore and has an outer diameter larger than the inner diameter of the proximal bore.
[0127] Example 5a The system of Example 4a, wherein in the undeployed configuration, the proximal portion of the distal actuator wire does not directly contact the distal aperture of the shaft. In the deployed configuration, the proximal portion of the distal actuator wire directly contacts the distal aperture of the shaft.
[0128] For example, Figure 7D shows the undeployed configuration, and Figure 7F shows the deployed configuration. In Figure 7D, the proximal actuator wire is free to move without affecting the distal actuator wire, which serves to mitigate interference between the distal actuator wire and the retaining wire.
[0129] FIG. 6 illustrates a problem addressed by some embodiments described herein. Such a problem exists in many conventional single-pull wire systems. Specifically, a conduit 601 includes an actuator wire 602 coupled to a medical device implant. The wire has a length (L) when unbent. Such bends can occur as it passes through a patient's vasculature. However, that same wire can potentially shorten when it assumes an outer radius (B), which can set the wire back a distance "j" from its distal origin position (x=0). Furthermore, that same wire can potentially lengthen when it assumes an inner radius (C), which can lengthen the wire a distance "k" from its distal origin position (x=0). This varying distance can affect the precision and comfort level of a physician implanting the device, and this variation is reduced in embodiments that allow for "splitting" the bend due to sliding cuffs 714, 715.
[0130] In an embodiment, wire 706 is omitted and instead cuff / hole 714 is at the location 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 the undeployed configuration, a distal portion of the proximal actuator wire does not directly contact the proximal bore of the shaft. In the deployed configuration, a distal portion of the proximal actuator wire directly contacts the proximal bore of the shaft.
[0132] Example 7a The system of Example 6a, wherein the retention wire has a proximal protrusion (724) that is proximal to at least a portion of the coil. In the undeployed configuration, the proximal protrusion does not directly contact the coil. In the deployed configuration, the proximal protrusion directly contacts the coil.
[0133] For example, in Figure 7E, partial actuation / deployment 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 to deploy the implant. This "direct actuation" gives the physician more control over implant placement.
[0134] In Figure 7F, both actuator wires are in full tension. Balls 716, 717 interpose holes 714, 715, allowing the physician to pull the four tensioned wires 703, 704, 705, 706 as a "compound" single-wire system. The gap 723 between the cuffs accounts for approximately 0.5-2% of the wire shortening (see radius B in Figure 6).
[0135] In FIG. 7G, the actuator coil engages 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, upon full actuation, the retention wire fully retracts into the lumen 709 (e.g., polyimide shaft or lumen). The detachment collar 702 can now be released from the system. The collar 702 may be radiopaque and may comprise platinum and / or iridium (e.g., an alloy or combination of platinum and / or iridium). Other embodiments may have a radiopaque collar comprising platinum and / or tungsten (e.g., an alloy or combination of platinum and / or tungsten). However, in other embodiments, the collar comprises stainless steel. The conduit 708 may be radiopaque and may comprise platinum and / or iridium and may function as a distal marker band.
[0136] Example 8a The system of Example 2a, wherein the retaining 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) contained in the second bore. 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 longitudinal axis (720). The proximal wall of the distal protrusion of the retention wire is non-orthogonal to the longitudinal axis of the second conduit.
[0139] Example 11a The system of Example 2a, comprising a third conduit (719), a portion of the third conduit contained within the first conduit but not the second conduit, and another portion of the third conduit contained within the second conduit but not the first conduit.
[0140] Conduit 719 may comprise polyimide and may act as an internal 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 longitudinal axis (720). A first plane (721) is perpendicular to the longitudinal axis. The first plane intersects the first conduit, the second bore, 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 a combination 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 hole.
[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. 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 longitudinal axis, and the first and second overlap distances are both parallel to the longitudinal axis.
[0149] Example 1b 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 comprises a first wire, a second wire, a third wire, and a shaft or wire coupling the first wire to the third wire. The system comprises a coil comprising the first wire but not the second wire. The system comprises (a) a first conduit releasably coupled to the medical implant and (b) a first conduit comprising the first wire and the second wire but not the coil. The system comprises (a) a second conduit releasably coupled to the medical implant and (b) a second conduit comprising the first wire, the second wire, and the coil. The first wire is (a) contained within the channel and (b) passing through the first hole but not the second hole. The second wire is (a) contained within the channel and (b) passing through the first and second holes.
[0150] As used herein, a "wire" includes a (solid or hollow) coupling agent such as a cord, a (solid or hollow) conduit, a shaft, a rod, etc., that has both stiffness (e.g., linear stiffness parallel to and along the long axis of the wire) and flexibility (e.g., radial flexibility perpendicular to the long axis of the wire) for the device to pass through the vasculature. Depending on the material used for the wire and the diameter of the wire as described herein, the wire may have various flexibilities. As used herein, wires and / or shafts such as elements 703, 704, 705, 706 may have equal or different flexibilities.
[0151] Embodiments may be used with SMP foam implants, but may be used more generally with medical implants.
[0152] Example 2b The system of Example 1b, wherein the shaft or wire has a distal lumen containing the first wire and a proximal lumen containing the third wire.
[0153] Example 3b The system of Example 2b, wherein the distal hole is slidably coupled to the first wire and the proximal hole is slidably coupled to the third wire.
[0154] Example 4b The system of Example 3b, wherein a proximal portion of the first wire is proximal to the distal hole and has an outer diameter greater than the 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 greater than the inner diameter of the proximal hole.
[0155] Example 5b The system of Example 4b, 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; and in the deployed configuration, the proximal portion of the first wire directly contacts the distal hole of the shaft or wire.
[0156] Example 6b The system of Example 5b, wherein in the undeployed configuration, the distal portion of the third wire does not directly contact the proximal aperture of the shaft or wire. In the deployed configuration, the distal portion of the third wire directly contacts the proximal aperture of the shaft or wire.
[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 undeployed configuration, the proximal protrusion does not directly contact the coil. In the deployed configuration, the proximal protrusion directly contacts the coil.
[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 contained in the second bore, the second wire having a body, and both the proximal and distal protrusions of the second wire extending radially away from the body of the second wire.
[0160] Example 10b The system of Example 9b, wherein the distal extension of the second wire has proximal and distal walls. The second conduit includes a longitudinal axis. The proximal wall of the distal extension of the second wire is non-orthogonal to the longitudinal axis of the second conduit.
[0161] Example 11b The system of Example 2b, comprising a third conduit, a portion of the third conduit contained within the first conduit but not contained within the second conduit, and another portion of the third conduit contained within the second conduit but not contained 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, and 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 longitudinal axis. The first plane is perpendicular to the longitudinal axis. The first plane intersects the first conduit, the second hole, 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 a combination 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 hole.
[0168] Example 18b The system of Example 1b, wherein the coil is non-releasably coupled to the distal actuation cord.
[0169] Example 19b The system of Example 1b, wherein in the non-deployed configuration, the shaft or wire overlaps the first wire by a first overlap distance. In the 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 longitudinal axis, and the first and second overlap distances are both parallel to the longitudinal axis.
[0170] Example 1c An embodiment includes 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) a first conduit (b) releasably coupled to the medical implant and including the first wire and the second wire but not the coil. The system further comprises (a) a second conduit (b) releasably coupled to the medical implant and including the first wire, the second wire, and the coil. The first wire is (a) contained within a channel of the medical implant and (b) configured to pass through a first hole in the medical implant but not through a second hole located in a sidewall of the medical implant. The channel connects the first hole to the second hole. The second wire is (a) contained within the channel and (b) configured to pass through the first and second holes.
[0171] The system may be manufactured, sold, and / or shipped 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 lumen containing the first wire and a proximal lumen containing 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 greater than the 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 greater than the inner diameter of the proximal hole.
[0175] Example 5c The system of Example 4c, wherein in the undeployed configuration, the proximal portion of the first wire does not directly contact the distal aperture of the shaft or wire. In the deployed configuration, the proximal portion of the first wire directly contacts the distal aperture of the shaft or wire.
[0176] Example 6c The system of Example 5c, wherein in the undeployed configuration, the distal portion of the third wire does not directly contact the proximal aperture of the shaft or wire. In the deployed configuration, the distal portion of the third wire directly contacts the proximal aperture of the shaft or wire.
[0177] Example 7c The system of Example 6c, wherein the second wire has a proximal protrusion proximal to at least a portion of the coil, wherein in the undeployed 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 of Example 2c, wherein the second wire has a proximal protrusion proximal to at least a portion of the coil.
[0179] Example 9c The system of Example 8c, wherein the second wire has a distal protrusion that will be contained in the second bore, the second wire having a body, and both the proximal and distal protrusions of the second wire extending radially away from the body of the second wire.
[0180] Example 10c The system of Example 9c, wherein the distal extension of the second wire has proximal and distal walls, the second conduit includes a longitudinal axis, and the proximal wall of the distal extension of the second wire is non-orthogonal to the longitudinal axis of the second conduit.
[0181] Example 11c The system of Example 2c, comprising a third conduit, a portion of the third conduit contained within the first conduit but not contained within the second conduit, and another portion of the third conduit contained within the second conduit but not contained within the first conduit.
[0182] Example 12c The system of Example 11c, 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.
[0183] Example 13c The system of Example 2c, comprising a void between the medical implant and the first conduit. The second conduit includes a longitudinal axis. The first plane is perpendicular to the longitudinal axis. The first plane intersects the first conduit, the void, and the second wire and is configured to intersect the second bore.
[0184] Example 14c The system of Example 13c, wherein the first plane intersects the first wire.
[0185] Example 15c The system of Example 13c, wherein the first conduit has a higher radiopacity than the second conduit.
[0186] Example 16c The system of Example 15c, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or a combination thereof.
[0187] Example 17c The system of Example 1c, wherein the first wire is in direct contact with the second wire and is configured to apply a force to maintain the second wire within the second hole.
[0188] Example 18c The system of Example 1c, wherein the coil is non-releasably coupled to the distal actuation cord.
[0189] Example 19c The system of Example 1c, wherein in the non-deployed configuration, the shaft or wire overlaps the first wire by a first overlap distance. In the 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 longitudinal axis, and the first and second overlap distances are both parallel to the longitudinal axis.
[0190] Example 1d An embodiment includes 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 comprises a first wire, a second wire, a third wire, and a shaft or wire coupling the first wire to the third wire. The system comprises (a) a first conduit releasably coupled to the medical implant and (b) the first wire and the second wire. The system comprises (a) a second conduit releasably coupled to the medical implant and (b) 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 the second hole. The second wire is (a) contained within the channel and (b) passes through the first and second holes.
[0191] Thus, not all embodiments include a coil. For example, the first wire may include a protrusion, shoulder, lip, etc. that cooperates with other system elements to position the implant.
[0192] Example 2d The system of Example 1d, wherein the shaft or wire has a distal lumen containing the first wire and a proximal lumen containing 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 a proximal portion of the first wire is proximal to the distal hole and has an outer diameter greater than the 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 greater than the inner diameter of the proximal hole.
[0195] Example 5d The system of Example 4d, wherein in the undeployed configuration, the proximal portion of the first wire does not directly contact the distal aperture of the shaft or wire. In the deployed configuration, the proximal portion of the first wire directly contacts the distal aperture of the shaft or wire.
[0196] Example 6d The system of Example 5d, wherein in the undeployed configuration, the distal portion of the third wire does not directly contact the proximal lumen of the shaft or wire. In the deployed configuration, the distal portion of the third wire directly contacts the proximal lumen 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 contained in the second bore, the second wire having a body, and both the proximal and distal protrusions of the second wire extending radially away from the body of the second wire.
[0200] Example 10d The system of Example 9d, wherein the distal extension of the second wire has proximal and distal walls, the second conduit includes a longitudinal axis, and the proximal wall of the distal extension of the second wire is non-orthogonal to the longitudinal axis of the second conduit.
[0201] Example 11d The system of Example 2d, comprising a third conduit, a portion of the third conduit contained within the first conduit but not contained within the second conduit, and another portion of the third conduit contained within the second conduit but not contained within the first conduit.
[0202] Example 12d The system of Example 11d, 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.
[0203] Example 13d The system of Example 2d, comprising a void between the medical implant and the first conduit, the second conduit having a longitudinal axis; and the first plane being perpendicular to the longitudinal axis. The first plane intersects the first conduit, the second hole, the void, and the second wire.
[0204] Example 14d The system of Example 13d, wherein the first plane intersects the first wire.
[0205] Example 15d The system of Example 13d, wherein the first conduit has a higher radiopacity than the second conduit.
[0206] Example 16d The system of Example 15d, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or a combination thereof.
[0207] Example 17d The system of 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 hole.
[0208] Example 18d The system of Example 1d, wherein in the non-deployed configuration, the shaft or wire overlaps the first wire by a first overlap distance. In the 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 longitudinal axis, and the first and second overlap distances are both parallel to the longitudinal axis.
[0209] Example 1e 1. A system comprising: 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 connecting the first wire to the third wire; a coil including the first wire but not the second wire; (a) a first conduit releasably coupled to the medical implant and (b) including the first wire and the second wire but not the coil; and (b) a second conduit releasably coupled to the medical implant and (b) including the first wire, the second wire, and the coil; wherein the first wire is (a) contained within the channel and (b) passing through the first hole but not through the second hole; and the second wire is (a) contained within the channel and (b) passing through the first and second holes.
[0210] Example 2e The system of Example 1e, wherein the shaft or wire has a distal lumen containing the first wire and a proximal lumen containing 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 of any of Examples 2e to 3e, wherein a proximal portion of the first wire is proximal to the distal hole and has an outer diameter greater than the 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 greater than the inner diameter of the proximal hole.
[0213] Example 5e The system of any of Examples 2e to 4e, 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; and in the deployed configuration, the proximal portion of the first wire directly contacts the distal hole of the shaft or wire.
[0214] Example 6e The system of Example 5e, 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; and in the deployed configuration, the distal portion of the third wire directly contacts the proximal hole of the shaft or wire.
[0215] Example 7e The system of any of Examples 5e to 6e, wherein the second wire has a proximal protrusion that is 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.
[0216] Example 8e The system of any of Examples 1e to 7e, wherein the second wire has a proximal protrusion proximal to at least a portion of the coil.
[0217] Example 9e The system of Example 8e, wherein the second wire has a distal protrusion contained 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.
[0218] Example 10e The system of any of Examples 8e to 9e, wherein the distal extension of the second wire has proximal and distal walls; the second conduit includes a longitudinal axis; and the proximal wall of the distal extension of the second wire is non-orthogonal to the longitudinal axis of the second conduit.
[0219] Example 11e The system of any of Examples 1e to 10e, comprising a third conduit, a portion of the third conduit contained within the first conduit but not contained within the second conduit; and another portion of the third conduit contained within the second conduit but not contained within the first conduit.
[0220] Example 12e The system of 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 The system of any of Examples 1e to 12e, comprising a void between the medical implant and the first conduit, the second conduit comprising a longitudinal axis; the first plane being perpendicular to the longitudinal axis; and the first plane intersecting the first conduit, the second hole, the void, and the second wire.
[0222] Example 14e The system of Example 13e, wherein the first plane intersects the first wire.
[0223] Example 15e The system of any of Examples 1e to 14e, wherein the first conduit has a higher radiopacity than the second conduit.
[0224] Example 16e The system of Example 15e, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or a combination thereof.
[0225] Example 17e The system of any 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 hole.
[0226] Example 18e The system of any of Examples 1e to 17e, wherein the coil is non-releasably coupled to the distal actuation cord.
[0227] Example 19e The system of any of Examples 1e to 18e, wherein in the non-deployed configuration, the shaft or wire overlaps the first wire by a first overlap distance; in the 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 longitudinal axis, and the first and second overlap distances are both parallel to the longitudinal axis.
[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, top, bottom, above, below, upward, downward, first, second, etc., which are used for descriptive purposes only and should not be construed as limiting. For example, terms specifying relative vertical position refer to a situation in which the side of a substrate is the "top" surface of that substrate; in fact, a substrate may be in any orientation, and thus the "top" side of a substrate may be lower than the "bottom" side in a standard terrestrial reference frame and still be within the meaning of the term "on." The term "on," as used herein (including in the claims), does not indicate that a first layer "on" a second layer is directly and immediately in contact with the second layer unless specifically stated so; there may be a third layer or other structure on the first layer between the first and second layers. The 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 recognize that many modifications and variations are possible in light of the above teachings. Those skilled in the art will recognize various equivalent combinations and substitutions for the various components shown in the figures. Accordingly, it is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto. (Other possible items) [Item 1] a medical implant having a channel, a first hole, and a second hole located in a sidewall of said 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 having said first wire but not said second wire; (a) a first conduit releasably coupled to the medical implant; and (b) a first conduit having the first wire and the second wire but not the coil; (a) a second conduit releasably coupled to the medical implant; and (b) the second conduit having the first wire, the second wire, and the coil; Equipped with the first wire (a) is contained within the channel and (b) passes through the first hole but not through the second hole; The system wherein the second wire (a) is contained within the channel and (b) passes through the first and second holes. [Item 2] Item 10. The system of item 1, wherein the shaft or wire has a distal lumen containing the first wire and a proximal lumen containing the third wire. [Item 3] 3. The system of claim 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 proximal to the distal hole and having an outer diameter greater than an inner diameter of the distal hole; 4. The system of claim 2 or 3, wherein a distal portion of the third wire is distal to the proximal hole and has an outer diameter greater than an inner diameter of the proximal hole. [Item 5] In the undeployed configuration, the proximal portion of the first wire does not directly contact the distal aperture of the shaft or wire; 5. The system of any one of items 2 to 4, wherein in an arrangement, the proximal portion of the first wire directly contacts the distal hole of the shaft or wire. [Item 6] In the non-deployed configuration, a distal portion of the third wire does not directly contact the proximal aperture of the shaft or wire; Item 6. The system of item 5, wherein in the arrangement, the distal portion of the third wire directly contacts the proximal hole of the shaft or wire. [Item 7] the second wire having a proximal protrusion proximal to at least a portion of the coil; In the undeployed configuration, the proximal protrusion does not directly contact the coil; 7. The system of claim 5 or 6, wherein in the arrangement, the proximal protrusion directly contacts the coil. [Item 8] 8. The system of any one of items 1 to 7, wherein the second wire has a proximal protrusion proximal to at least a portion of the coil. [Item 9] the second wire having a distal projection contained within the second bore; Item 9. The system of item 8, wherein the second wire has a body, and the proximal and distal projections of the second wire both extend radially away from the body of the second wire. [Item 10] the distal projection of the second wire includes a proximal wall and a distal wall; the second conduit having a longitudinal axis; 10. The system of claim 8 or 9, wherein the proximal wall of the distal projection of the second wire is non-orthogonal to the longitudinal axis of the second conduit. [Item 11] a third conduit; a portion of the third conduit is contained within the first conduit but not within the second conduit; 11. The system of any one of items 1 to 10, wherein another portion of the third conduit is contained within the second conduit but not contained within the first conduit. [Item 12] the third conduit is fixedly coupled to at least one of the first or second conduits; Item 12. The system of item 11, wherein the third conduit is slidably coupled to both the first and second conduits. [Item 13] a void between the medical implant and the first conduit; the second conduit having a longitudinal axis; a first plane perpendicular to said longitudinal axis; 13. The system of any one of items 1 to 12, wherein the first plane intersects the first conduit, the second hole, the void, and the second wire. [Item 14] Item 14. The system of item 13, wherein the first plane intersects the first wire. [Item 15] 15. The system of any one of items 1 to 14, wherein the first conduit has a higher radiopacity than the second conduit. [Item 16] Item 16. The system of item 15, wherein the first conduit comprises at least one of platinum, iridium, tungsten, or a combination thereof. [Item 17] 17. The system of any one of items 1 to 16, wherein the first wire is in direct contact with the second wire and applies a force to maintain the second wire within the second hole. [Item 18] 18. The system of any one of items 1 to 17, wherein the coil is non-releasably coupled to a distal actuation cord. [Item 19] In the non-deployed configuration, the shaft or wire overlaps the first wire by a first overlap distance; In an arrangement, the shaft or wire overlaps the first wire by a second overlap distance that is less than the first overlap distance; 19. The system of any one of items 1 to 18, wherein the second conduit has a longitudinal axis, and the first overlap distance and the second overlap distance are both parallel to the longitudinal axis.
Claims
1. an implant comprising a shape memory polymer (SMP) and a collar; a first wire and a second wire; a first conduit containing the first wire and the second wire; a second conduit containing the first wire; at least a portion of the collar is between the SMP and the first conduit; the collar includes a channel, a first hole at a proximal end of the collar, and a second hole in a sidewall of the collar; the channel connects the first hole to the second hole; the second wire is contained in the channel, the first hole, and the second hole; The system wherein the first wire is contained within the channel and the first hole, but not within the second hole.
2. The system of claim 1 , wherein a plane intersects the second wire, the collar, and the second hole.
3. The system of claim 2 , wherein the plane does not intersect with the first hole.
4. 4. The system of claim 3, wherein the second wire is coupled between the first conduit and the first wire via a resistance fit.
5. The system of claim 4 , wherein the resistive fit is removed when the first wire is moved proximally and away from the collar.
6. The system of claim 5 , wherein the implant is configured to separate from the first conduit when the resistance fit is removed.
7. the second wire has a proximal protrusion proximal to at least a portion of the second conduit; In the undeployed configuration, the proximal protrusion does not directly contact the second conduit; In the arrangement, the proximal projection directly abuts the second conduit. The system of claim 2 .
8. The system of claim 7 , wherein the second wire has a distal protrusion contained in the second hole.
9. the distal projection of the second wire has a proximal wall and a distal wall; the second conduit includes an axis extending from a proximal end of the second conduit to a distal end of the second conduit; the proximal wall of the distal projection of the second wire is non-orthogonal to the axis of the second conduit; The system of claim 8.
10. the second wire is configured to be pulled and to be withdrawn from the first hole and the second hole in response to the first wire being pulled in a proximal direction, such that when the first wire is pulled in a proximal direction, the second conduit contacts the proximal protrusion and moves the proximal protrusion in a proximal direction. The system of claim 8.
11. The system of claim 7 , wherein the first conduit is more radiopaque than the second conduit.
12. the first wire directly contacts the second wire and applies a force to maintain the second wire within the second hole. The system of claim 7.
13. The system of claim 7 , wherein the plane intersects the first wire.
14. The system of claim 7 , wherein the second conduit is slidably coupled to the second wire.
15. the collar has a distal end opposite the proximal end of the collar; the sidewall of the collar connects the proximal end and the distal end of the collar to one another; The system of claim 7.
Citation Information
Patent Citations
Intraluminal coil delivery system with mechanical release mechanism
JP2000510350A
Systems, devices, and methods for delivering lumen occlusion devices using distal and / or proximal control.
JP2015508673A
Occlusion Medical Device System
JP2020510492A
Occlusive implants for hollow anatomical structures, delivery systems, and related methods
US20140236127A1
Detachable Coil Release System and Handle System
US20150335333A1