Medical device with enhanced shape features

Abstract

A medical device is disclosed that can have a helical shaped structure that can be used as a stent, such as a flow diversion stent for treating an aneurysm. The medical device can have a helical shaped structure that can be used as an occlusive device, such as for occluding an aneurysm. The medical device can include a shape setting structure to selectively adjust the shape of the medical device.

Description

[0001] Related applications

[0002] This application is a non-provisional application filed on July 16, 2019, entitled Spiral Flow Diverter, U.S. Provisional Application No. 62 / 874,846, and claims priority thereto, the entirety of which is incorporated herein by reference. Background Technology

[0003] An aneurysm is a bulge along the wall of a blood vessel, caused by weakening of a region of artery. If left untreated, an aneurysm can rupture over time, leading to complications such as a stroke. A ruptured intracranial aneurysm can develop into a hemorrhagic stroke, which can either prove fatal or cause permanent neurological damage.

[0004] Aneurysms are traditionally treated with clipping or occlusion. Occlusion involves filling the aneurysm with an occluder, such as a coil, to block blood flow to the aneurysm and cut off its blood supply over time.

[0005] The latest technology in aneurysm treatment has utilized the use of shunt stents, which are braided tubular devices placed across the neck of the aneurysm. A shunt stent (also called a shunt device) uses a low-porosity interface to restrict blood flow into the aneurysm, inducing blood flow stagnation within the aneurysm. This helps to cut off the blood supply to the aneurysm over time to reduce the likelihood of rupture, and also promotes endothelial growth on the stent over time to occlude the aneurysm.

[0006] Traditional shunts utilize a fixed tubular or cylindrical stent structure with a consistent low-porosity profile along its entire length. However, this design leads to complexities. For example, due to its fixed tubular shape, a typical shunt stent is rigid, making deployment difficult in certain situations, such as when an aneurysm is located in a curved section of an anatomical structure. Furthermore, traditional shunt stents are not repositionable after a certain point during deployment. Typically, there is a mechanical connection between the delivery pusher and the stent, and once the stent loses engagement with this connection (e.g., when the stent expands during delivery), the stent is no longer attached to the delivery pusher and can no longer be repositioned.

[0007] Conventional shunts have fixed dimensions, where a physician needs to determine the size of the blood vessel prior to surgery and then utilize a shunt of a particular size to fit a particular target location. Complications can result if the stent does not expand properly (e.g., due to pressure from the vessel wall, or by being deployed through a curved bend), or if the stent is the incorrect size resulting in complications with the flow diversion properties of the stent. For example, if the stent is too small, then the stent can not sit flush against the neck of the aneurysm, thereby hindering the shunting effect of the stent. If the stent is too large relative to the blood vessel, then the stent can not properly deploy from the delivery catheter, or assume the correct shape after deployment.

[0008] There is a need for a shunt stent that addresses at least these issues.

[0009] In some cases, occlusion can be considered a better treatment option for treating an aneurysm than shunting. One newer occlusion device is referred to as an endoluminal device, which tends to focus on blood flow blockage at the neck of the aneurysm to help prevent blood flow into the aneurysm. These endoluminal devices utilize structures such as a mesh to occupy space within the aneurysm to provide occlusion and prevent blood flow into the aneurysm, while also providing a barrier along the neck of the aneurysm. Generally, these devices are well suited to adjust to the size and dimensions of the aneurysm. However, it is difficult to design an endoluminal device that both sufficiently occludes the aneurysm and also well covers the neck of the aneurysm to help prevent blood flow into the aneurysm. Generally, this is because occlusion devices, including endoluminal devices, have fixed shapes and structures.

[0010] There is a need for an occlusion device that addresses at least these issues.

[0011] Conventional medical devices, such as stents or occlusion devices, have specific fixed dimensions and are generally heat set to an expanded state that the device assumes when deployed from a delivery catheter. Thus, there is a fixed, smaller profile delivery state when the device is within the catheter and a fixed, heat set expanded state when the device is outside of the catheter. However, there is no way to adjust the size or shape of the device after deployment, where the ability of the implant to assume an alternative shape can help enhance treatment of a particular target area.

[0012] There is a need for a medical device, such as a stent or occlusion device, that addresses at least these issues. SUMMARY

[0013] In some embodiments, a stent is described.

[0014] In one embodiment, a stent is described that is specifically used as a shunt stent for treating an aneurysm. In one embodiment, the stent takes a helical shape. In one embodiment, the stent is composed of one or more metal wires woven into a helical shape. In one embodiment, the stent utilizes a multi-layer (e.g., double-layer) helical shape. In one embodiment, the multi-layer stent utilizes wires, where some of the wires in one layer are offset relative to some of the wires in the other layer, thereby enhancing the flow disruption effect of the stent.

[0015] In one embodiment, the stent utilizes a shape setting structure to adjust the profile of the stent. In one embodiment, the shape setting structure is one or more wires connected to the stent. In one embodiment, the shape setting structure is one or more wires interwoven or intertwined with the stent. In one embodiment, the shape setting structure is a stent-like structure. In one embodiment, the shape setting structure utilizes electrically conductive elements (e.g., wires). In one embodiment, the shape setting structure undergoes a heat treatment step such that the shape setting structure takes a particular shape when heated to a particular temperature. In one embodiment, the shape setting structure is heated to a particular temperature to take a particular shape in order to urge the implant into a particular shape. In one embodiment, the stent has a particular use as a shunt stent for treating an aneurysm.

[0016] In one embodiment, a method of treating a vascular disease with a stent is described. One method includes providing a stent having a helical shape, deploying the stent through a delivery catheter and out of the delivery catheter such that the stent takes its helical shape, thereby treating the vascular disease with the helically shaped stent. In one embodiment, the stent is composed of one or more metal wires woven into a helical shape. In one embodiment, the stent utilizes a multi-layer (e.g., double-layer) helical shape. In one embodiment, the multi-layer stent utilizes wires, where some of the wires in one layer are offset relative to some of the wires in the other layer, thereby enhancing the flow disruption effect of the stent. In one embodiment, a method of treating an aneurysm is described. One method includes providing a shunt stent having a helical shape, deploying the shunt stent through a delivery catheter and out of the delivery catheter such that the shunt stent takes its helical shape, thereby blocking blood flow into the aneurysm with the helically shaped stent.

[0017] In one embodiment, a method of treating a vascular disease is described. One method includes providing a stent, expanding the stent at least partially from a delivery catheter such that at least a portion of the stent assumes an expanded shape, and activating a shape setting structure to cause the stent to adopt a different shape configuration (e.g., a helix). In one embodiment, the shape setting structure is one or more wires attached to the stent. In one embodiment, the shape setting structure is one or more wires interwoven or intertwined with the stent. In one embodiment, the shape setting structure is a stent-like structure. In one embodiment, the shape setting structure utilizes electrically conductive elements (e.g., wires). In one embodiment, the shape setting structure undergoes a heat treatment step such that the shape setting structure adopts a particular shape when heated to a particular temperature. In one embodiment, the shape setting structure is heated to a particular temperature to adopt a particular shape in order to cause the implant to enter a particular shape. In one embodiment, the stent has a particular use as a shunt stent for treating an aneurysm. In one embodiment, a method of treating an aneurysm is described. One method includes providing a shunt stent, expanding the shunt stent at least partially from a delivery catheter such that at least a portion of the stent assumes an expanded shape, and activating a shape setting structure to cause the shunt stent to adopt a different shape configuration (e.g., a helix).

[0018] In some embodiments, an occlusion device is described.

[0019] In one embodiment, the occlusion device is used to occlude an aneurysm. In one embodiment, the occlusion device adopts a helical shape. In one embodiment, the occlusion device is composed of one or more metal wires woven into a helical shape. In one embodiment, the occlusion device adopts a multi-layer (e.g., double-layer) helical shape. In one embodiment, the multi-layer occlusion device utilizes wires, where some of the wires in one layer are offset relative to some of the wires in another layer, thereby increasing resistance to blood flow or flow disruption.

[0020] In one embodiment, a method of occluding an aneurysm is described. One method includes expanding an occlusion device from a delivery catheter and out of the delivery catheter into an aneurysm, whereby the occlusion device adopts its helically expanded shape to occlude the aneurysm. In one embodiment, the occlusion device is composed of one or more metal wires woven into a helical shape. In one embodiment, the occlusion device adopts a multi-layer (e.g., double-layer) helical shape. In one embodiment, the multi-layer occlusion device utilizes wires, where some of the wires in one layer are offset relative to some of the wires in another layer, thereby increasing resistance to blood flow or flow disruption. In one embodiment, a method of occluding a treatment region is described. One method includes expanding an occlusion device from a delivery catheter, out of the delivery catheter and into a treatment region to treat a vascular disease, whereby the occlusion device adopts its helically expanded shape to occlude the treatment region.

[0021] In one embodiment, a closure device is described that utilizes a shape setting structure to adjust the shape, configuration, or profile of the device. In one embodiment, the shape setting structure is one or more wires connected to the closure device. In one embodiment, the shape setting structure is one or more wires interwoven or intertwined with the closure device. In one embodiment, the shape setting structure is a stent-type structure. In one embodiment, the shape setting structure utilizes electrically conductive elements (e.g., wires). In one embodiment, the shape setting structure undergoes a heat treatment step such that the shape setting structure adopts a particular shape when heated to a particular temperature. In one embodiment, the shape setting structure is heated to a particular temperature to adopt a particular shape in order to change the implant (e.g., closure device) to a particular shape. In one embodiment, the closure device has a particular use as an aneurysm closure device, such as an intravascular device.

[0022] In one embodiment, a method of occluding a treatment region is described. One method includes delivering a closure device through a delivery catheter and out of the delivery catheter such that at least a portion of the closure device is outside of the delivery catheter, activating a shape setting structure to adjust the shape, profile, or configuration of the closure device, and occluding the treatment region with the closure device. In one embodiment, the shape setting structure is one or more wires connected to the closure device. In one embodiment, the shape setting structure is one or more wires interwoven or intertwined with the closure device. In one embodiment, the shape setting structure is a stent-type structure. In one embodiment, the shape setting structure utilizes electrically conductive elements (e.g., wires). In one embodiment, the shape setting structure undergoes a heat treatment step such that the shape setting structure adopts a particular shape when heated to a particular temperature. In one embodiment, the shape setting structure is heated to a particular temperature to adopt a particular shape in order to change the implant (e.g., closure device) to a particular shape. In one embodiment, the closure device has a particular use as an aneurysm occluder, such as an intravascular device. In one embodiment, a method of occluding an aneurysm is described. One method includes delivering a closure device through a delivery catheter and out of the delivery catheter such that at least a portion of the closure device is outside of the delivery catheter and in the aneurysm, activating a shape setting structure to adjust the shape or configuration or profile of the closure device, and occluding the aneurysm with the closure device.

[0023] In one embodiment, a method of manufacturing a medical device including a flow diversion stent and / or a closure device is described. One method includes forming a tubular structure, in one embodiment, by weaving one or more wires on a mandrel to form a tubular structure composed of one or more layers. The tubular structure is then compressed to form a compressed multi-layer structure. The multi-layer structure is then helically wrapped on a tubular mandrel to form a multi-layer helical tube. In one embodiment, one or more wires of the medical device proximal end are releasably connected to a delivery pusher to deliver the medical device.

[0024] In one embodiment, the medical device utilizes a mechanical delivery pusher connected to the proximal end of the medical device. In one embodiment, the medical device is a helical member. In one embodiment, the medical device is a stent, such as a shunt stent. In one embodiment, the medical device is an occluder. In one embodiment, the delivery system utilizes a connection interface between the delivery pusher and the medical device, wherein the connection interface comprises a proximally positioned wire comprising a proximal portion of the medical device. In one embodiment, the delivery pusher comprises a detachment system that detaches the delivery pusher from the medical device. In one embodiment, a thermal detachment system is used. In one embodiment, the detachment system comprises a first system that detaches the medical device and a second system that activates a shape setting structure to adjust the shape, profile, or configuration of the medical device.

[0025] In one embodiment, a method of detaching a medical device, such as a stent or occluder, is described. One method comprises delivering the medical device to a treatment site, such as an aneurysm, deploying the medical device, and activating a detachment system to detach the delivery pusher from the medical device.

[0026] In one embodiment, a shape setting system comprising a shape setting structure is described. In one embodiment, the shape setting system utilizes a shape setting structure, in one embodiment one or more wires, and a heating system connected to the shape setting structure to deliver an electrical current through and thereby heat the shape setting structure. In one embodiment, heating the shape setting structure adjusts its shape, profile, or configuration, such as causing it to elongate, or causing it to expand, or causing it to adopt a different shape, thereby adjusting or changing the shape, profile, or configuration of a medical device / implant connected to or integral with the shape setting structure. In one embodiment, the shape setting structure utilizes a structure, such as one or more wires, that is thermally set into a particular shape at a particular transition temperature, such that when the structure is later exposed to the transition temperature, the structure subsequently adopts the thermally set shape. In one embodiment, the medical device is a stent, such as a shunt stent. In one embodiment, the medical device is an occluder.

[0027] In one embodiment, a method of using a shape setting system or shape setting structure to change the shape, profile, or configuration of a medical device or implant, such as a stent or occluder, is described. One method comprises activating a heating system connected to the shape setting structure to deliver an electrical current through and thereby heat the shape setting structure, thereby adjusting its shape or profile or configuration, and thereby adjusting the shape or profile or configuration of a medical device connected to or integral with the shape setting structure. In one embodiment, the method of forming the shape setting structure comprises winding the shape setting structure into a particular shape on a mandrel and heat setting the shape at an appropriate transition temperature above body temperature so as to impart the transition temperature to the shape setting structure.

[0028] In one embodiment, a medical device that can be selectively used as a stent or an occlusive device is described. In a first configuration, the device is used as a shunt stent, spanning an aneurysm neck, to shunt blood flow from the aneurysm. In a second configuration, the device is used as an occlusive device placed within the aneurysm to occlude the aneurysm.

[0029] In one embodiment, a method of using a medical device that can be selectively used as a stent or an occlusive device is described. One method includes deploying the medical device to a treatment site (e.g., an aneurysm), deploying the medical device out of a delivery catheter to cause the medical device to assume a different shape, and treating the medical condition with the different shape. In one embodiment, the method further includes activating a shape setting structure associated with the medical device to cause the medical device to assume the different shape in order to treat the target site with the medical device having the different shape.

[0030] In one embodiment, a method of changing a shape of an implantable device is described. One method includes providing a stent having a constrained state, an unconstrained state, and a preset shape; providing a shape changing device associated with the stent; and selectively activating the shape changing device to change the stent from the unconstrained state to the preset shape.

[0031] In one embodiment, a medical implant is described. One medical implant includes a tubular structure; the tubular structure is configured to have a resting shape and an operational shape; a shape setting mechanism associated with the tubular structure; the shape setting mechanism is operable to selectively change the tubular structure from the resting shape to the operational shape. BRIEF DESCRIPTION OF DRAWINGS

[0032] These and other aspects, features, and advantages of embodiments of the application will become apparent from the following description of the embodiments of the application, taken in conjunction with the accompanying drawings, which are by way of illustration, in which:

[0033] Figure 1 A tubular structure for creating a multi-layer implant according to one embodiment is shown;

[0034] Figure 2 A tubular structure on a mandrel according to one embodiment is shown; Figure 1

[0035] Figure 3 A front profile of a tubular structure according to one embodiment is shown;

[0036] Figure 4 A compressed front profile of a tubular structure according to one embodiment is shown;

[0037] Figure 5 ​A pre-compression profile of a tubular structure is shown according to another embodiment;

[0038] Figure 6 A side view of a compressed tubular structure is shown according to one embodiment;

[0039] Figure 7 A helical structure on a mandrel is shown according to one embodiment;

[0040] Figure 8 A side profile of a helical structure is shown according to one embodiment;

[0041] Figure 9 A helical stent for treating an aneurysm is shown according to one embodiment;

[0042] Figure 10 A plurality of wire layers used in a helical structure is shown according to one embodiment;

[0043] Figure 11 A delivery system for delivering a helical structure is shown according to one embodiment;

[0044] Figure 12 A delivery system for delivering a helical structure and including a detachable joint is shown according to one embodiment;

[0045] Figure 13 A heating element for detaching a helical structure is shown according to one embodiment;

[0046] Figure 14 A helical stent for treating an aneurysm and a helical occluder for occluding an aneurysm are shown according to one embodiment;

[0047] Figure 15 An occluder having a complex shape and including an internal member is shown according to one embodiment;

[0048] Figure 16 An elongated implant including a shape setting structure is shown according to one embodiment;

[0049] Figure 17 An implant having a helical shape Figure 16 according to one embodiment;

[0050] Figure 18 An implant / pusher interface for an implant utilizing a shape setting structure is shown according to one embodiment;

[0051] Figure 19 An interface for an implant when within a delivery catheter is shown according to one embodiment; Figure 18

[0052] Figure 20 ​shown is a shape setting structure according to one embodiment having a serpentine shape; Figure 18

[0053] Figure 21 shown is a shape setting structure according to one embodiment having a serpentine shape;

[0054] Figure 22 shown is a shape setting structure according to one embodiment having a serpentine shape. DETAILED DESCRIPTION

[0055] Stents have a variety of applications in the vasculature, for example to assist in maintaining patency of a blood vessel. One class of stents discussed above are referred to as flow diverting stents, which are implanted in a blood vessel near the neck of an aneurysm to help reduce or limit the amount of blood flow into the aneurysm. Flow diverting stents utilize a relatively low porosity (when porosity is defined as the amount of open space in the stent, for example, the inverse of the percentage of area contained by the stent material itself) to help limit the amount of blood flow into the aneurysm.

[0056] Traditional stents, including flow diverting stents, utilize a fixed tubular structure. However, such designs are generally rigid, and therefore can cause complications when deployed, for example in smaller blood vessels (such as in the neurovasculature), or along a tortuous anatomical structure. The following embodiments generally relate to stents, including flow diverting stents, and have particular utility in treating aneurysms in the neurovasculature.

[0057] Figure 1 A tubular structure 100 for manufacturing a helical stent is shown. The tubular structure 100 is composed of a mesh or braid of one or more wires, braided together to form such a shape. In one embodiment, a metal shape memory wire is used (such as Nitinol, stainless steel, cobalt-chrome alloy). In a preferred embodiment, Nitinol is used. In one embodiment, drawn filled tubes (DFTs) are used that utilize a radiopaque (such as platinum or tantalum) core and an outer metal (such as Nitinol) sheath; these DFT elements look like wires and function like wires.

[0058] ​In one embodiment, the tubular mesh or braid 100 utilizes optional radiopaque threads 102 (e.g., tantalum or platinum) to aid in visualization. The radiopaque threads 102 are interwoven in the remainder of the braid 100 such that the radiopaque threads 102 form part of the braid or mesh. In one embodiment, the radiopaque threads 102 are wound simultaneously with and in the same manner as the other threads of the braid. In one embodiment, the radiopaque threads 102 are wound in an over-under manner with respect to the other threads of the braid (e.g., over a thread portion, under another thread portion, etc.) so as to interweave the radiopaque threads 102 as part of the mesh. In one embodiment, as an additional step, the radiopaque threads 102 are wound after the other threads of the implant and in an over-under pattern with respect to the other threads of the mesh (e.g., in the over-under manner described above) so as to interweave the radiopaque threads 102 as part of the mesh.

[0059] In one embodiment, the radiopaque / visualization threads 102 are thicker than the threads of the remainder of the braid 100. This increased thickness can provide advantages in terms of visualization and imparting increased stiffness to the tubular braid 100 (as radiopaque materials are generally stiffer than their more flexible shape memory counterparts). In one example, the braid 100 is comprised of one or more threads having a diameter of about 0.01 mm - 0.08 mm, while the radiopaque threads 102 have a diameter of about 0.05 mm - 0.15 mm. In one example, the braid 100 is comprised of one or more threads having a diameter of about 0.025 mm - 0.075 mm, while the radiopaque threads 102 have a diameter of about 0.05 mm - 0.1 mm.

[0060] In one embodiment, the tubular mesh or braid 100 is single-layered and formed by braiding one or more threads around a tubular mandrel to create the tubular mesh shape, as shown in Figure 2 Mandrel 104. Figure 3 This view shows the general cross-sectional profile of this tubular shape. This view can be considered the front end of the tubular shape. In various embodiments, the mandrel 104 can be oriented horizontally or vertically. A horizontal mandrel configuration is shown in Figure 2 A vertical mandrel configuration would have the mandrel flipped 90 degrees so that any windings are wrapped in a vertical manner (e.g., against gravity or with gravity). One advantage of a vertical mandrel configuration is that gravity can be used as an additional force to aid the winding process when wound in a top-down manner.

[0061] After this step, the tubular mesh or braid 100 is then configured into a helical shape. The tubular mesh 100 is first removed from the mandrel 104 and compressed to form a multi-layered (e.g., double-layered) structure. This is shown in the context of Figures 3-5 In one embodiment, the tubular mesh 100 is compressed to form a double-layered structure. This is shown in the context of Figure 3In this case, a tubular shape is created with a top tubular portion 100a and a bottom tubular portion 100b. The tubular shape is then compressed (by force F) to form a compressed and curved structure as shown in Figure 4 or Figure 5 different cross-sections as shown in Figure 4 In this case, the tubular shape is compressed such that the top tubular portion 100a and the bottom tubular portion 100b are adjacent or nearly adjacent, thereby forming a compressed and curved structure. In this case, the compressed and curved structure can be considered to have a cross-sectional shape that is curved or bent. Figure 5 In this case, the tubular shape is compressed to form a flattened cross-sectional shape, which in some embodiments can be considered to be a flat or thin strip-like shape. Figure 6 shows a side view of the initially tubular structure taking on an elongated and compressed shape 106 after being flattened or compressed, which can be considered to be a different shape 106 in Figure 1 In this case, the tubular structure 100 in

[0062] After this step, the tubular mesh or braid 100 is then constructed into a spiral shape. The tubular mesh 100 is first removed from the mandrel 104 and compressed to form a multi-layer (e.g., double layer) structure. This is shown in the context of Figures 3-5 Figures 3-5 represents a front view or cross-section of the tubular structure 100 (e.g., if the user is facing the inner cavity of the tubular structure 100). In this case, a tubular shape is created with a top tubular portion 100a and a bottom tubular portion 100b. The tubular shape is then compressed (by force F) to form a compressed and curved structure as shown in Figure 3 or Figure 4 different cross-sections as shown in Figure 5 In this case, the tubular shape is compressed such that the top tubular portion 100a and the bottom tubular portion 100b are adjacent or nearly adjacent, thereby forming a compressed and curved structure. In this case, the compressed and curved structure can be considered to have a cross-sectional shape that is curved or bent. Figure 4 In this case, the tubular shape is compressed to form a flattened cross-sectional shape, which in some embodiments can be considered to be a flat or thin strip-like shape. Figure 5 shows a side view of the initially tubular structure taking on an elongated and compressed shape 106 after being flattened or compressed, which can be considered to be a different shape 106 in Figure 6 In this case, the tubular structure 100 in Figure 1 In this case, the tubular structure in Figure 6 The view in Figures 3-5 In this case, the tubular structure is rotated 90 degrees after being compressed to show a side view instead of a front view.

[0063] As shown in Figures 4-6 ​As shown, since the helical shape is created from a two-layer structure consisting of the first layer 100a above the second layer 100b, the helix itself will be two layers. However, in other embodiments, even more layers can be used (e.g., if a multi-layered tubular braid is initially created, compressing the braid will further increase the number of layers). Thus, the helical wire itself will consist of at least two layers, but can also consist of more layers (e.g., 4, 6, 8, 10, or more).

[0064] The multi-layered helical structure is shown in FIG. 1 1 1 as Figure 8 where a single or particular helical component (e.g., one winding 108a of the helical pattern 108) consists of two overlapping layers 100a, 100b. The layers 100a, 100b can be constructed so that there is an open space or gap 1 12 between the layers (note that this is different from the gap 1 10 in Figure 7 FIG. 1 10, Figure 7 which represents the gap between adjacent windings of the helical pattern 108). The open space or gap 1 12 can be controlled by using connecting elements at particular locations that connect the two layers together, where the number of connections and the strength / tension of the bond between the layers affects the size of any open space / gap. Alternatively, adhesive bonding can be used if the area between the bonding points will be slightly spaced apart to create an area with an open space / gap.

[0065] Alternatively, the layers 100a, 100b can be constructed so that there is no such open space, such that one layer is directly opposite another layer in a flush manner. This can be achieved, for example, by using many closely constructed connecting elements along several portions of each winding of the helical pattern, or by using a continuous / substantially continuous adhesive portion to closely bond the layers 100a, 100b together.

[0066] The multi-layered helical pattern (i.e., where each winding of the helical pattern consists of two or more layers) has some significant advantages where the helical pattern shape is used as a stent, particularly as a flow diversion stent (also referred to as a flow diverter). This is shown in the context of Figure 9 FIG. 1 12, where the helical flow diversion stent 1 18 consists of multiple individual windings 1 18a, 1 18b, etc. Where each winding 1 18a, 1 18b, etc. is its own individual helical component. The flow diversion stent 1 18 is implanted in the blood vessel 1 16 adjacent to the aneurysm 1 14 and is used to reduce the blood flow into the aneurysm and to promote clotting in the aneurysm neck region to seal off the aneurysm.

[0067] As each winding 118a, 118b, etc. is composed of multiple (e.g., at least two) layers, as described previously and herein, any blood passing through the shunt stent 118 needs to pass through multiple layers of wire to enter the aneurysm, creating a barrier to blood flow, causing blood flow to be interrupted or shunting to be exacerbated. Thus, the wire of each layer of winding of the helical stent 118 provides a barrier to shunting of blood into the aneurysm, with each subsequent layer providing an additional barrier. In one embodiment, the shunting effect is further enhanced when the wire of one layer is offset relative to the wire of another layer. This configuration is illustrated in Figure 10 , where the wire 120 of one layer (larger gray line) is offset relative to the wire 122 of another layer (smaller black line). Although the size of the line / wire is illustrated as different in the context of Figure 10 , in one embodiment, the wire comprising the braid of the helical shunt stent is substantially similar. As can be seen in Figure 10 , the offset configuration will increase the resistance to blood flow, increasing the flow shunt. For example, the offset pattern can be constructed by adhering the layers together (e.g., by mechanical connection, welding, or adhesive) in a manner where one layer is offset relative to another.

[0068] In another embodiment, the layers are configured such that one layer is not offset relative to another, meaning that the wire of one layer is substantially aligned with the wire of another. For example, this alignment can be constructed by adhering the layers together (e.g., by mechanical connection, welding, or adhesive) in a manner where the wire of one layer is aligned relative to the wire of another.

[0069] In another embodiment, the layers are configured such that a portion of the braid is aligned with the wire of one layer and a portion of the braid is offset from the wire of another layer. Similar to the description above, the adhesive mechanism and pattern can be constructed in a particular manner in various regions of the braid to achieve this.

[0070] Note that for Figure 9The helical shunt stent shown is generally advantageous in that a single winding 118a of the helical pattern is directly flush with or overlaps with an adjacent single winding 118b (meaning a portion of the winding is above or below the adjacent winding). The purpose of this is to ensure that there are no gaps between the windings through which blood can pass, allowing blood to enter the aneurysm unimpeded. In one embodiment, a directly adjacent or overlapping configuration can be provided during the winding pattern on the axial axis (e.g., adjacent windings are flush with or overlap each other during the helical winding pattern). In another embodiment, small gaps can be introduced between adjacent windings; however, because the shunt stent is typically too large relative to the vessel size, it is placed during the treatment procedure (often to ensure the shunt stent is flush with the aneurysm neck), and this oversized size results in adjacent windings being directly adjacent to each other or slightly overlapping, leaving no open space between the stent windings during stent implantation.

[0071] The stent 118 is connected to the delivery actuator 126 for delivering the stent 118 to the target treatment site via a catheter, such as... Figure 11 As shown. The stent 118 has a flat / compressed and elongated construction when it is inside the delivery conduit, and then adopts an expanding spiral shape outside the delivery conduit.

[0072] Note that for the purposes of this publication, the terms proximal and distal will be used interchangeably. Proximal should be considered as the direction toward the surgeon performing the procedure, which is also the direction away from the patient and outside the vascular system. Distal should be considered as the direction toward the patient, i.e., toward the area of ​​the patient's vascular system, or further inward within the patient's vascular system.

[0073] The pusher 126 is a tubular or solid structure that the user grips proximally and uses to push the attached stent 118 through the catheter and to the treatment location. In one embodiment, the stent 118 is made of one or more metal wires wound from proximal to distal (e.g., in...). Figure 11 In the context of left to right), then wrap in the distal to proximal direction (e.g., in Figure 11 (From right to left in the context). This results in each of the one or more threads in the braid being woven in such a way that each thread will begin at a proximal position and end at a proximal position. Then one or more threads forming the support 118 (e.g., Figure 11 The eight wires shown in the example extend proximally and connect to the actuator 126. Thus, the support 118 and the actuator 126 are connected via an extension connection interface 124. In one embodiment, the wires forming the extension connection interface 124 are covered by a tubular covering element or covering structure. Although in Figure 11In the context of FIG. 1, the elongate wire interface 124 is shown as relatively long, but the interface 124 can be any length, in one example, the interface 124 is relatively short so as to minimize the profile of any elongate element extending proximally from the stent 118. In one embodiment, the connecting interface 124 is itself woven so as to be considered a woven extension of the rest of the stent 118.

[0074] Figure 12 The connecting interface 124 between the pusher 126 and the stent 118 is shown in more detail. The wire forming the proximal end of the connecting interface 124 is connected to a tubular marker element 128. In one example, the marker element 128 is radiopaque to help visualize the distal end of the pusher 126 / proximal end of the stent 118. In one example, the proximal end of the wire forming the connecting interface 124 is welded or otherwise connected to the inner lumen of the tubular marker element 128 or the outer surface of the marker element 128. In alternative constructions, the marker element 128 is a solid structure rather than a tube.

[0075] A separation interface 130 is located at the proximal end of the marker element 128. The separation interface 130 is a separable (e.g., mechanical, electrolytic, or thermal) joint to separate the marker 128 and the wire interface 124 from the rest of the pusher 126. In one example, the separation interface 130 is a heat-activated joint that is activated by a heater coil 134 connected to the pusher 126. Figure 13 In the illustrated embodiment, the separation interface 130 includes an elongate tether 132 extending between the distal portion of the inner lumen of the pusher 126 and the marker element 128, and a heater coil 134 connected to the pusher 126 that can be heated to heat and sever the tether 132 based on user action (e.g., via a proximal button).

[0076] In one example, the tether 132 is connected at one end to the inner lumen of the pusher 126 or to the outer surface of the pusher 126 and at the other end to the inner lumen of the marker element 128. Cutting the tether 132 will separate the marker 128 and the wire interface element 124 (connected to the marker 128) from the pusher 126 and the heater 134. The heater 134 is not separated and remains connected to the pusher 126. Wires (not shown) are connected at each end of the heater 134 such that a first wire is connected to a first end of the heater 134 and a second wire of opposite polarity is connected to a second end of the heater 134. These wires can pass through the inner lumen of the pusher 126 or be external to the pusher 126 and extend all the way to the proximal end of the pusher where each wire is connected to an associated contact at the proximal end of the pusher 126. Each contact has opposite polarity (one positive and one negative) so that the contacts, wires, and heater form a circuit. The pusher is then connected to an external interface / separation controller (e.g., a handheld separation element) to initiate the separation procedure. The external controller will have the appropriate circuitry and voltage source (e.g., a battery) that aligns with the proximally directed pusher contacts to polarize them and cause current to flow through the pusher 126 (through the wires) to heat the heater 134 to initiate the separation. See U.S. Patent No. 9,717,500 for more details on the thermal separation system, which is incorporated by reference herein in its entirety.

[0077] Alternative embodiments of the separation interface 130 can utilize a meltable portion (e.g., a polymer knot) that is heated by a heater to initiate thermal separation. Other embodiments of the separation interface 130 can utilize a mechanical connection, such as a screw, where the user would simply rotate the screw-like interface element in a particular direction to initiate the separation. Alternatively, an electrolytic system can be used where one wire is used to polarize a corrodible separation joint and the patient’s blood provides the return to complete the separation circuit. An electrolytic separation system is discussed in U.S. Patent No. 5,122,136, which is incorporated by reference herein in its entirety. Any separation technology generally known to those skilled in the art for separating implants can be used to separate the stent 118 from the pusher 126.

[0078] Although the stent 118 is primarily described as a flow diversion stent, the stent can also be used for other functions, such as a stent element to prevent other embolic material (e.g., embolic coils) that occludes an aneurysm from being dislodged from the aneurysm.

[0079] To this point, the present disclosure has discussed a helical shaped element that can be used as a stent, such as a flow diverter stent. As previously mentioned, the helical shape is more flexible than a fixed tubular shape (the latter being a traditional stent design and shape). This flexibility has significant advantages in the deployment of smaller vessels in the neurovascular system, where curved vasculature makes deployment more difficult and a stent must have good flexibility to adapt to the shape of the vasculature. This flexibility also provides additional advantages that make this design useful for other medical devices in addition to stents.

[0080] In other embodiments, the helical structure can be used as an embolic or occlusive element to occlude a target site. As previously mentioned, the helical shape has some key advantages in terms of flexibility. This flexibility is also advantageous for occlusion devices, where a flexible device is better able to manipulate its shape and adopt the shape of a target region, such as an aneurysm. These features help with the occlusion and packing of an aneurysm. Additionally, the enhanced packing or occlusive properties can further increase the disruption of blood flow in the aneurysm neck, which helps prevent blood flow into the aneurysm.

[0081] Figure 14 An example is shown in which one or more helical occlusive structures 138 are deployed into an aneurysm 114, which are manufactured in a manner similar to the helical structures previously described, but are specifically configured for occlusive purposes. Another helical stent structure 118 (or, alternatively, a traditional tubular stent structure) is placed as a stent element against the aneurysm to help hold the occlusive structures 138 in the aneurysm.

[0082] When used for occlusive purposes, the occlusive structures 138 can be uniquely configured for occlusive purposes (e.g., through device size, density / pic count of the mesh / braiding, and / or wire size used to create the braiding / mesh) rather than for stent implantation purposes. Desirable occlusive properties include a small profile and highly flexible shape that is able to pack within an aneurysm, and the helical occlusive structures 138 can be configured with these parameters to be used as occlusion devices. For example, the helical occlusive structures can be one or more of: smaller, composed of more wires (thereby promoting softness), composed of smaller wires, and / or configured with larger gaps between windings as compared to the helical stent structures.

[0083] In another embodiment, the occlusive structures 138 form other (e.g., non-helical) shapes. For example, the occlusive structures can form an elongated linear conformable mesh, in which the linear mesh is highly flexible so as to adopt the shape of a target region (e.g., an aneurysm). In one embodiment, the linear occlusive structure includes a metal wire or elongated element that runs within an internal channel and between opposite ends of the occlusive structure. In one embodiment, the internal metal wire or elongated element is tensioned to help deploy and help push the linear occlusive structure to form a curved shape (e.g., increase the packing shape) upon deployment.

[0084] Figure 15 Another embodiment shown utilizes an occlusive structure 140 having a curvilinear or complex (e.g., three-dimensional) shape. In one embodiment, the occlusive structure 140 is heat set into this complex shape. Alternatively, the occlusive structure 140 includes an internal wire or tether 142 that is heat set into the complex shape that the occlusive structure 140 is subsequently to assume, such that the internal member 142 exerts a force on the occlusive structure 140 to assume its complex or curvilinear shape. Figure 15 The shape shown is one example of a curvilinear or complex type shape, but various such shapes can be utilized to enhance the packing ability and occlusive effect of the occlusive structure 140.

[0085] Each structure (the stent structure 118 and the occlusive structure 138, as shown) is delivered by a separate catheter. The first catheter is inserted into the aneurysm. Then, the second catheter is deployed in the parent vessel across the aneurysm neck, and the helical stent 118 is deployed from the second catheter. One or more helical occlusive structures 138 (e.g., typically for occlusion, multiple structures are deployed in sequence until the aneurysm is sufficiently occluded) are then fed into the aneurysm 114 from the first catheter, and once the procedure is complete, the first and second catheters are removed. Figure 14 Medical devices, including stents and occluders, must be properly sized relative to the target treatment site. This requires an initial imaging step of the treatment site to determine the proper size of the device for the treatment target space, so that the facility or physician can order a particular size device to perform the procedure. However, problems can arise if the target space size measurement is incorrect, or the device does not properly deploy, and thus does not properly expand to the intended size in the target space (e.g., due to mechanical problems with the device, or blood vessel conditions, such as a tortuous blood vessel that causes deployment or expansion difficulties). Moreover, medical devices are typically only configured to perform one intended function, and are not configured, for example, to change shape to perform another intended function. Furthermore, most medical devices are heat set to assume a particular set-up deployment shape; however, there is typically no way to facilitate the device assuming a unique shape according to the particular size or geometry of a particular blood vessel condition. The following embodiments address at least these problems by utilizing a shape setting system that includes a shape setting structure to help change the shape of a medical device.

[0086]

[0087] Figure 16 ​An implant 200 woven from one or more metal wires is shown. The implant 200 is in a first elongated configuration and connected to a pusher 226 at a proximal end. The implant 200 includes a shape setting structure, described below, for changing the shape, configuration, or profile of the woven implant 200. The shape setting structure is part of a larger shape setting system. In one embodiment, the shape setting structure (shown) includes first and second conductive elements 206a, 206b that extend through the length of the implant 200. Figure 16

[0088] In one embodiment, the conductive elements 206a and 206b are conductive wires interwoven or intertwined with the mesh wires comprising the implant 200. In terms, the conductive elements 206a, 206b can be considered conductive wire elements, conductive core wire elements, conductive core wire sections, shape setting members, or shape setting structures, as these functions are the same elements responsible for shape setting. In one example, the conductive elements 206a, 206b are interwoven or intertwined with each other throughout the mesh in a manner similar to how the radiopaque wires 102 are interwoven through the mesh, as described earlier herein. In one example, the conductive elements 206a, 206b are interwoven with each other in a separate procedure through the implant 200 after the implant 200 is initially woven with its element wires. In another example, the conductive elements 206a, 206b are entangled or woven with the constituent wires of the implant weave as the implant 200 is being woven. Figure 1

[0089] In another embodiment, the conductive elements 206a, 206b are directly connected to the weave on the inner or outer surface of the weave 200 such that the conductive elements 206a, 206b directly contact one or more wires of the weave 200 but are not interwoven or intertwined with the implant weave 200.

[0090] Shape memory implants (e.g., stents or occluders using shape memory materials) generally use a first shape or configuration and a second shape or configuration, where the first shape / configuration is the shape the implant assumes when constrained within a delivery catheter. The first shape is elongated and compressed, considered a stress-induced martensitic phase.

[0091] The second shape assumes a heat treatment step in which the device is heat treated (e.g., after being wound on a mandrel) at a specific temperature (e.g., about 20 degrees Celsius or 68 degrees Fahrenheit) and means the expanded shape the device assumes when released from the delivery catheter. This shape is considered a super-elastic shape, considered an austenitic phase. The relatively low temperature ensures that the device expands at ambient temperatures and in the human body, which can be quite warm at about 98.6 degrees Fahrenheit.

[0092] ​​Shape-setting structures (e.g., leads 206a, 206b) are used to apply a third shape to the implant based on heating of the shape-setting structure. Leads 206a, 206b are wound around a mandrel to employ a specific configuration (e.g., Figure 17 The spiral structure shown in the diagram allows for the heat treatment of conductors 206a and 206b at a specific temperature above body temperature to form the shape after reaching that specific temperature. This temperature can be considered the transition temperature, to which the conductive conductors 206a and 206b take on their third shape once heated. In one example, the transition temperature is between 37 degrees Celsius / 98.6 degrees Fahrenheit and 42 degrees Celsius / 108 degrees Fahrenheit. In some examples, values ​​of 38 degrees Celsius, 39 degrees Celsius, or 40 degrees Celsius may be used as the transition temperature. When used in a procedure, a heating element or system is used to heat the conductors 206a and 206b to the transition temperature to form the third or fourth shape. Since the rest of the implant 200 is connected to the wires 206a, 206b (e.g., because the wires are intertwined / braided between the wires of the implant 200, or because the wires are directly connected to the wires of the implant 200), the rest of the implant 200 also adopts this third shape as the wires 206a, 206b change their shape to the third shape.

[0093] Therefore, the implant 200 and the shape-setting structure (e.g., leads 206a, 206b) have three shapes. When the implant 200 adopts its second shape, it is in a first elongated / compressed shape when inside the delivery catheter, in a second shape when released from the delivery catheter based on exposure to ambient / blood temperature, and in a third shape when the shape-setting structure / leads 206a, 206b are heated.

[0094] In one embodiment, conductive elements 206a and 206b are configured to not exceed a specific temperature threshold (e.g., 42 degrees Celsius). Techniques for ensuring that the specific temperature (e.g., 42 degrees Celsius) is not exceeded include constructing a system to ensure that a specific current threshold is not exceeded, wherein the current threshold is associated with the specific temperature (e.g., 42 degrees Celsius) to ensure that the specific temperature is never reached. Optionally, an automatic shutdown function can be triggered once the specific current or temperature threshold is detected.

[0095] In one embodiment, the construction of the woven implant 200 is similar to that discussed above and Figures 7-9 Other multi-layered (two or more) braids shown, wherein the braided implant initially employs a linear, elongated profile (e.g., if...). Figure 7 or Figure 9 The spiral shape is stretched / stretched, and then, once the conductive elements 206a and 206b reach their transition temperature and change shape into a spiral structure, the spiral structure is then employed. Figure 7 orFigure 9 The helical multi-layer shape is shown to encourage the remainder of the implant braid 200 to also adopt a helical structure.

[0096] In one embodiment, the conductive elements 206a, 206b are braided with the mesh implant in a manner similar to the radiopaque wires 102 braided with each other or braided with each other in the mesh implant, as described earlier herein. In one example, the conductive elements 206a, 206b are similar in size to the other wires forming the mesh implant 200 (e.g., about 0.025 mm - 0.075 mm in diameter), or larger in size than the wires forming the mesh implant 200 (e.g., about 0.05 mm - 0.15 mm in diameter). Figure 1

[0097] In one embodiment, the conductive elements 206a, 206b are composed of a good shape memory material, enabling them to be heat set in an appropriate curved or helical shape for heating / expanded shape; the conductive elements 206a, 206b should also be good conductors to facilitate current flow and heat generation. In one embodiment, Nitinol is used, which is a good shape memory metal material. Other materials, such as stainless steel or cobalt-chrome, can also be used. In one embodiment, a drawn filled tube is used with a radiopaque metal core (e.g., platinum, platinum / tungsten alloy, gold, or tantalum) and a shape memory metal sheath (e.g., Nitinol, stainless steel, or cobalt-chrome). The conductive elements 206a, 206b can further include a high resistance region (e.g., band or crimped / helical shape) along their length to promote heat generation.

[0098] There are several techniques that can be used to maximize the retention of heat along the conductive elements 206a, 206b and prevent tissue damage from thermal exposure. In one embodiment discussed earlier, a current or temperature threshold or automatic shut-off feature is utilized to maintain a specific current or temperature profile along the conductive elements 206a, 206b. In another embodiment, an insulating material (e.g., polymer or metal with low electrical conductivity) is used around the conductive elements 206a, 206b. In one embodiment, the insulating material surrounds the conductive elements 206a, 206b, for example as a peripheral hollow tube. In one embodiment, the implant 200 itself is coated with an insulating material (e.g., polymer).

[0099] As Figure 17 ​As shown, the conductive elements 206a, 206b are connected to the proximal heating mechanism 202. In one embodiment, the conductive elements 206a, 206b consist of one wire that is wrapped in a first distal direction to the distal end of the implant (thus forming element 206a), and then wrapped in a proximal direction back to the proximal end of the implant (thus forming element 206b). In another embodiment, the conductive elements 206a, 206b are two separate wires. The first wire 206a is wrapped from the proximal end to the distal end and connected to the conductive band 204. In one embodiment, the conductive band 204 is radiopaque (e.g., platinum-iridium, which is radiopaque and also has good conductive properties) to enhance the visibility of the distal end of the implant, thus serving as a radiopaque marker. The second wire 206b is wrapped from the distal end to the proximal end and connected to the conductive band 204. The conductive band 204 provides an electrical connection between the first and second wires 206a, 206b. Alternative constructions can utilize thin conductive tubing instead of wires to form the conductive elements 206a, 206b.

[0100] Figure 18 One embodiment of a heating mechanism 202 for heating the conductive elements 206a, 206b is shown. The distal end of the pusher 226 includes a first electrical contact 228 and a second electrical contact 230; these are oppositely polarized so that the first contact 228 is, for example, positive, while the second contact 230 is, for example, negative - although alternatively, this construction can be switched. The first and second contacts 228, 230 are polarized by wires 228a, 230a so that wire 228a is connected to contact 228 and wire 230a is connected to contact 230. The wires 228a, 230a are each connected to a voltage source of opposite charge at the proximal end of the system (e.g., positive and negative terminals), and in this way, these wires carry the relevant current to each contact 228, 230.

[0101] In one embodiment, one or more of the contacts 228, 230 are tubular bands; where the tubular construction allows the wire 230a to pass through the more proximally oriented contact 228 to connect to the distally oriented contact 230. As shown, each contact is enlarged relative to the distal portion of the pusher 226. Figure 18 Figure 18 The proximal ends of the conductive elements 206a and 206b are shown, where Figure 18 ​The proximal ends of the conductive elements 206a, 206b are shown connected to the heater mechanism. The conductive element 206a has a coil 208a at its proximal end; the proximal coil 208a is electrically conductive and is capable of being electrically connected with the contact 228. The second conductive element 206b has a coil 208b at its proximal end, the proximal coil 208b is electrically conductive and is capable of being electrically connected with the second contact 230. In one example, the coils 208a, 208b are radiopaque, such as tantalum, platinum, palladium, or gold, to increase the visibility of the proximal end or proximal region of the braided implant 200.

[0102] In the case where the conductive elements 206a, 206b are comprised of a single wire having a lateral portion from the proximal end to the distal end (e.g., 206a) and a lateral portion from the distal end to the proximal end (e.g., 206b), each end of the single wire is connected to (or in electrical communication with) a different contact, such that one end is connected to the contact 228 and the other end is connected to the contact 230. In the case where the conductive elements 206a, 206b are comprised of two separate wires that are bridged together by a distal conductive band, the proximal end of the first wire is connected to the contact 228, while the proximal end of the second wire will be connected to the contact 230.

[0103] Because the proximal end of the first conductive element 206a is connected to a first contact 228 of one polarity (e.g., positive polarity) and the proximal end of the second conductive element 206b is connected to a second contact 230 of another polarity (e.g., negative polarity), a circuit is completed whereby current will flow from, for example, the first conductive element 206a distally to the distal end of the braided implant and back via the second conductive element 206b. The current causes the first and second conductive elements 206a, 206b to heat up, thereby employing helical or curved shape memory to cause the braided implant to assume its subsequent (e.g., helical) shape.

[0104] The user will activate the heater mechanism by including a power / voltage source in a hand-held mechanism (e.g., pressing a button on a hand-held controller connected to the pusher 226 proximal end) to cause current to flow through the contacts and through the connected conductive elements 206a, 206b, thereby causing the implant 200 to assume a helical shape, profile, or configuration.

[0105] Figure 18 The embodiments presented herein do not necessarily require a separate system to separate the implant 200 from the pusher 226, as the proximal marker coils 208a, 208b forming the proximal ends of the conductive elements 206a, 206b are contained within a recess defined between the enlarged contacts 228, 230 when the braided implant 200 (or at least the proximal end of the implant 200) is contained within the delivery catheter— which is Figure 19The marker coils 208a, 208b are shown in more detail in the context of the covered delivery catheter 232. The marker coils 208a, 208b are horizontally constrained between the enlarged contact points 228, 230, and are vertically constrained by the overlying guide sheath / catheter 232 and the underlying pusher portion.

[0106] When the entire implant 200 is pushed distally or the catheter 232 is retracted to fully expose the implant 200, the marker coils 208a, 208b are no longer constrained and then release the implant as shown in Figure 20 In one embodiment, the remaining wire forming the implant 200 is connected to a distal ribbon element (not shown, but distal of the contact point 230). The ribbon element can serve a similar function as the marker 128 shown in Figure 12 The marker 128 serves as a proximal gathering location for the wire forming the implant 200. This additional ribbon element is part of the implant itself and thus separates with the implant, while the contact point 230 and everything proximal of the contact point is part of or connected to the pusher 226 and thus does not separate with the implant 200.

[0107] In alternative embodiments, rather than the catheter 232 providing the constraining force to prevent or enable separation, a separation system such as shown in Figure 13 is used, whereby the user can interact with a controller mechanism connected to the pusher 126, 226. The controller mechanism would have two control interfaces (e.g., buttons), where activating the first button would heat the conductive elements 206a, 206b to cause the implant to assume the helical shape post-deployment shape, and activating the second button would activate the separation system to subsequently separate the implant.

[0108] One major advantage of using a shape setting structure (e.g., the conductive elements 206a, 206b) to help the implant 200 assume a subsequent post-deployment shape is that the device does not necessarily need to be sized specifically for a vascular setting (e.g., as a shunt stent or as an occluder). Even if the diameter of the helical shape is larger than the blood vessel in which the device is placed, the blood vessel wall provides a retaining force to limit how large of a shape the device can assume. Thus, in one example, an all size fits all elongated structure can be used to treat a variety of blood vessel sizes and vascular conditions, where the elongated structure assumes different shapes (e.g., helical shapes) after the shape setting structure is heated / activated.

[0109] In addition to arranging the implant in a helical shape, systems and methods for applying current through the conductive elements 206a, 206b of the implant to arrange it in another shape can be used in a variety of different ways. For example, this technique and system can be used to arranging the implant in various distinct, different shapes (e.g., not just helical shapes). The key feature is that the conductive elements 206a, 206b are wound into a specific shape and then heat-set at a specific transition temperature, such that the conductive elements 206a, 206b take on that shape once heated to that specific transition temperature. Once that specific transition temperature is reached due to connection to or interweaving with the conductive elements 206a, 206b, the remainder of the implant takes on the shape of the conductive elements.

[0110] In one embodiment, the shape parameters are reversed such that the initial primary or delivery shape (e.g., the expanded shape that the device initially presents when delivered from the delivery conduit) is a spiral or coil shape, and then the subsequent or third shape adopted by the conductive elements 206a, 206b (and implant 200) once heated is a more elongated or linear shape.

[0111] In an alternative embodiment, conductive elements 206a and 206b may have different characteristics. Figures 16-17 The diagram illustrates alternative constructions of one or two elements. Figure 18 In this context, conductive elements 206a and 206b have two proximal portions that can be connected to the actuator 226 and electrically connected to the polarized contacts 228 and 230. However, conductive elements 206a and 206b can have complex shapes that reach or extend to the two proximal nodes. For example, instead of a thin metal segment advancing from the proximal end of the implant to the distal end and then returning to the proximal end, the thin metal segment can be zigzag-like (e.g., having many curves or complex shapes) – Figure 22An example is shown. One advantage of this structure is that a larger area of ​​the implanted braid 200 will contact the area of ​​the conductive elements 206a, 206b, thereby increasing the shape manipulation effect of the implanted braid 200 when the conductive elements take on their specific shape profiles once heated to a specific transition temperature. In another configuration, the conductive elements 206a, 206b can utilize more support shapes that are structurally similar to the implanted braid 200 but located above, below, or interwoven with the implanted braid 200. One advantage of this configuration is that many portions of the implanted braid 200 will have adjacent conductive elements 206a, 206b, thereby enhancing the shape manipulation effect of the implanted braid 200 when the conductive elements 206a, 206b take on their third shape once heated to a specific transition temperature. Although selective shapes are shown or described exemplarily to provide an example, any number of shapes can be considered without limitation, as any shape can be created simply by utilizing the specific winding shape of the shape-setting members (e.g., the conductive elements 206a, 206b). For example, Figure 15 An optional complex shape is shown, which can be used as a third shape, which can be selectively activated by activating the shape setting component.

[0112] In one embodiment, such as Figure 21 As shown, conductive elements 206a and 206b include intermediate spring-like or coil-like shapes 234a and 234b. One advantage of this shape is that the nested windings of these shapes increase resistance when current flows through them, thereby increasing the associated temperature and thus allowing conductive elements 206a and 206b to increase in temperature without requiring a large current. Although this configuration is shown using a uniform shape (meaning conductive elements 206a and 206b are a single, integral element), this configuration could alternatively utilize connecting strips (e.g., Figure 16 (204) and two separate wire elements connected by a connecting band.

[0113] The shape setting structures discussed herein can be used such that the implant selectively adopts a particular shape or configuration upon heating to a particular transition temperature point after deployment. In some embodiments, the mechanism can be used to selectively allow the implant to operate as an occlusion device or a stent device, where the device in a first elongated and deployed configuration can operate as an occlusion net, but the user can selectively cause the implant to adopt a different helical configuration as a shunt by activating at the transition temperature. In some embodiments, the mechanism can be used to selectively allow the implant to adopt multiple shapes for treating a particular condition. For example, the user can treat an aneurysm with an elongated braid, or activate a different subsequent shape configuration by activating at the transition temperature to cause the braid to adopt another (e.g., helical) configuration, and then occlude the aneurysm with this alternate helical shape.

[0114] In one example, multiple implants 200 capable of selectively adopting a tertiary (e.g., helical) shape can be used for multiple purposes at a treatment site. For example, a user can first place a first implant as a stent in the aneurysm neck adjacent a blood vessel, where a particular shape (e.g., helical) is activated by the shape setting member. Then, the user can deploy a second implant as an occlusion in the aneurysm, where the user can optionally activate the shape setting member to cause the implant to adopt a particular (e.g., helical) shape to present another occlusion shape.

[0115] In alternative embodiments, the heating system (via contacts 228, 230 configured to deliver current through the shape setting members / conductive elements 206a, 206b) is configured with a user interface such that a user can apply a selective amount of current to control the extent to which the shape setting members / conductive elements 206a, 206b adopt their third (e.g., helical) shape, and thus the extent to which the implant 200 adopts its own third (e.g., helical) shape. In this way, the user can control the extent to which the implant changes its shape. When the conductive elements 206a, 206b reach their shape memory transition temperature, they will begin to adopt a particular (e.g., helical) shape. In one embodiment, this is not necessarily an immediate transition, as continued exposure to current at the transition point will cause the associated shape to change over time. In one example, once a certain desired shape (e.g., a partial helix rather than a full helical shape) is reached, the user can activate a dial or button to begin the shape transition process, and then stop the transition by activating the same dial or button (e.g., move the dial up and down, or dial the button once, and then turn it off by pressing the button again). In this way, the user can control the particular final shape profile of the implant. This control is desirable in certain situations, for example, where the implant is larger than the vessel, and a partial helical shape is suitable for the target treatment area, e.g., for use as a shunt. Alternatively, if the user wants to use the implant as an occluder, the user can control the final deployed shape of the occluder based on the particular geometry or shape of the target treatment area (e.g., aneurysm). In alternative embodiments, the heat-induced / current-induced shape formation is more direct; non-exhaustive factors affecting the time considerations include: the size of the implant, how much of the implant is in contact with the shape setting structure, the power associated with the heating system, and how much current is passed through the shape setting structure (e.g., conductive elements 206a, 206b), and the difference between the body temperature and the shape memory transition temperature of the shape setting structure.

[0116] Note that embodiments regarding Figures 16-22 generally utilize a three-phase shape mechanism, where a first elongated / compressed shape is adopted in the delivery catheter, a second expanded shape is adopted when released from the delivery catheter and a particular low ambient temperature is reached, and a third post-expanded shape is adopted when the shape setting member or structure is subsequently heated to a particular transition temperature. In some terminology, the shape adopted by the implant while inside the catheter can be considered a first or delivery shape, the shape adopted by the implant when it initially expands upon being released from the catheter can be considered a second shape, and the shape (e.g., helical) adopted by the implant when the shape setting structure is heated to a particular transition temperature can be considered a third shape. Alternatively, the stent can be considered to assume a first or primary expanded shape upon release from the delivery catheter, and then assume a second expanded shape after the shape setting structure is heated to a particular transition temperature to impart a different deployed post-shape (e.g., helical) to the implant.

[0117] In terms of terminology, an implant according to embodiments herein can comprise three shapes or three states when used in conjunction with the shape setting structure disclosed herein (the structure can also be considered a state setting structure as it affects the shape and / or state of the implant). The implant is in a first, compressed or elongated state when contained within a delivery catheter. The implant is in a second, resting or expanded state which the implant adopts once released from the delivery catheter and exposed to ambient or blood temperature, thereby causing the implant to adopt its expanded delivery configuration. Finally, the implant is in its third or final state - which can be considered a post- expansion state or final preset state - when the implant is heated after delivery (e.g. by heating the shape or state setting structure as described in the various embodiments above and herein). The final preset state can be considered an operational state or operational shape as the third or final state will be utilized by the operation or procedure.

[0118] Although the present specification has primarily described the use of the shape or state setting structure in conjunction with implants configured as stents or occluders, the structure can in principle be used to change the shape or state of a variety of implants and likewise these embodiments are not in any way limited. Although the term stent is often used in the specification, the embodiments described herein can be used in a variety of artificial vascular devices, such as stents, stent grafts and vascular stents.

[0119] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth used herein are to be understood as approximations based on the desired properties sought to be obtained by the present application. Accordingly, unless otherwise indicated, the numerical parameters set forth in the specification and attached claims are approximations. At the very least, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the application are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0120] The use of the terms "a" and "an" and "the" and similar referents in the context of describing the application (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate the application and does not pose a limitation on the scope of the application unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential.

[0121] Groupings of alternative elements or embodiments of the application disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other alternative elements and / or embodiments found herein. One or more members of a group can be included in, or deleted from a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus resulting in a patentable range.

[0122] Certain embodiments of the application are described herein, including the best mode known to the inventors of practicing the application. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art once the nature of the application has been disclosed herein. Alterations and further modifications of the specifically disclosed embodiments are also intended and expected, and applicants intend to garner the full scope of the application as described by all of the claims appended hereto and equivalents thereof. In addition, where necessary, the components of the application have been marked pursuant to 37 CFR 1.77(a)(5)(i).

[0123] In addition, numerous references have been made to patents and printed publications throughout this specification. Each of the above-cited references and printed publications are herein incorporated by reference in their entirety.

[0124] Finally, it is to be understood that the embodiments of the application disclosed herein are illustrative of the principles of the present application. Other modifications that can be employed are within the scope of the application. As such, the application is not to be limited to the precise details of methodology or construction set forth herein as such variations fall within the scope of the application. Accordingly, while the application is susceptible to various modifications and alternative constructions, certain illustrated embodiments thereof are shown in the drawings and will be described hereinbelow in detail. It should be understood, however, that there are many variations of the embodiments of the application that are not specifically shown herein, but are nonetheless within the scope of the application.

Claims

1. A medical implant comprising: a stent structure comprising one or more stent wires woven together to form an elongated mesh; a shape setting structure comprising one or more guide wires positioned along the elongated mesh; a first coil located at a proximal end of the shape setting structure and in electrical contact with a first electrical contact of a pusher; and a second coil located at the proximal end of the shape setting structure and in electrical contact with a second electrical contact of the pusher; wherein the first coil and the second coil are horizontally constrained between the first electrical contact and the second electrical contact; wherein the one or more guide wires have a transition temperature that changes a shape of the stent structure to an operational configuration when powered through the first electrical contact of the pusher, the second electrical contact of the pusher, and the one or more guide wires of the shape setting structure.

2. The medical implant of claim 1, wherein the one or more guide wires are directly connected to the elongated mesh on an inner surface of the elongated mesh or an outer surface of the elongated mesh such that the one or more guide wires directly contact the elongated mesh without being interwoven or intertwined with the elongated mesh.

3. The medical implant of claim 1, wherein the one or more guide wires are intertwined with the elongated mesh.

4. The medical implant of claim 1, wherein the elongated mesh is formed from a flat woven tube.

5. The medical implant of claim 1, wherein the one or more guide wires have an intermediate coil shape.

6. The medical implant of claim 1, wherein the shape setting structure comprises two guide wires connected by a distal conductive band.

7. The medical implant of claim 1, wherein the first coil is disposed at a proximal portion of the one or more guide wires. the first coil is disposed at a proximal portion of a first guide wire and the second coil is disposed at a proximal portion of a second guide wire.

8. The medical implant of claim 6, wherein the two leads comprise a first lead and a second lead; and wherein, the first coil and the second coil are horizontally constrained within a groove defined between the first electrical contact and the second electrical contact.

9. The medical implant of claim 1, wherein the pusher comprises a groove between the first electrical contact and the second electrical contact; and wherein, 10. The medical implant of claim 1, wherein the one or more guide wires are coated with an insulating material.

11. The medical implant of claim 1, wherein the operational configuration is a helical shape.

12. The medical implant of claim 1, wherein the operational configuration is a curvilinear shape. ​

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