Intravascular implants and devices and methods for creating percutaneous arteriovenous fistula

Abstract

Various systems, devices, and methods for endovascular implants and accurate placement thereof are disclosed. The implant includes a proximal implant section, a distal implant section, a connector strut connecting the proximal implant section to the distal implant section, and a side opening between the proximal implant section and the distal implant section. The implant can be used to create an arteriovenous fistula or to connect one blood vessel to another blood vessel of the body by placing the proximal implant section and the distal implant section within the blood vessel to be connected. The implant may include one or more anchors for securing the implant in place relative to the blood vessel of the body to which it is attached. The implant may also include a continuous strut or ring at the distal edge of the proximal implant section. Also disclosed are methods for accurate percutaneous placement of the disclosed implants, as well as devices for percutaneous delivery.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 340,834, filed on May 11, 2022, and U.S. Provisional Patent Application No. 63 / 497,945, filed on April 24, 2010, the entire contents of each of which are incorporated herein in their entirety for all purposes. Technical Field

[0003] Certain aspects herein relate to intravascular implant systems, methods, and devices that provide accurate percutaneous placement in the vasculature, including for forming an arteriovenous (AV) fistula in the arm for dialysis access. Background Art

[0004] There are many interventional endovascular procedures that have been developed and performed that require accurate placement of implants such as intravascular stents, filters, and covered stents (stent grafts), to name a few. These endovascular procedures treat conditions such as vascular occlusive disease, vascular aneurysmal disease, and other abnormalities of the vascular system. They can also be used to treat hypertension, portal hypertension, and systemic hypertension by shunting blood flow from the hypertensive vascular system to the low-pressure venous system. Another possible treatment that can be performed by endovascular surgery is to create an arteriovenous fistula by placing a vascular implant between a vein and an artery to create a vascular access for hemodialysis.

[0005] These intravascular implant surgeries typically rely on expensive radiographic imaging (such as fluoroscopy, etc.) and significant operator skill to accurately position the catheter-based delivery system prior to deployment and delivery of the implant. These techniques require special operating rooms, lead-based protective equipment, and injection of toxic contrast agents into the patient, which can cause undue stress on the renal system. Transcutaneous ultrasound imaging does not provide the image resolution required to ensure accurate positioning during these surgeries. Improved implants and methods are needed.

[0006] Hemodialysis can especially benefit from improved implants and methods.Hemodialysis is a life-saving treatment for renal failure that uses a machine called a dialyzer to filter the patient's extracorporeal blood.During surgery, vascular access is needed to remove and return blood.During hemodialysis, blood from the patient will flow from a point in the access (e.g., from a needle piercing the access vein) through a tube to the dialyzer, where waste and extra fluid are filtered out and then returned to a separate point in the access (e.g., by piercing another needle or other into the same access vein) through different tubes to return it to the patient.During hemodialysis treatment, vascular access allows a large amount of blood to flow continuously, so that as much blood as possible can be filtered during surgery.Vascular access is usually composed of two types: long-term use including arteriovenous fistulas and arteriovenous grafts, and short-term use including intravenous catheters.

[0007] An arteriovenous (AV) fistula for hemodialysis is typically a connection between an artery and a vein that is formed by a vascular surgeon. In creating an AV fistula, the vascular surgeon connects the patient's artery to the patient's vein. Placement of an AV fistula is typically in the forearm or upper arm, and for ease of access, it is desirable to connect an artery (which is located within the muscle close to the deep veins) to a superficial vein (which is located on top / outside the muscle and closer to the surface). An AV fistula exposes the vein to increased pressure and blood flow, causing the vein to grow larger and stronger. The enlarged vein provides an easier and more reliable target for vascular access, the increased blood flow allows single venous access and more blood to be filtered, and the increased strength enables the vein to handle repeated needle insertions for consecutive treatments, as well as preventing the vein from collapsing during surgery.

[0008] An AV graft for hemodialysis is typically a loop of plastic tubing that connects an artery and a vein and is implanted in the patient's body (e.g., it does not leave the skin) surgically installed by a vascular surgeon. In contrast to the patient's vein being used for vascular access during hemodialysis, an AV graft is used to access the vasculature (e.g., the access needle pierces the graft tubing rather than the patient's vein).

[0009] An intravenous catheter for hemodialysis is a tube inserted into a vein in the patient's neck, chest, or leg near the groin, and is usually used only for short-term hemodialysis due to the increased risk of sepsis and death through this approach. The tube splits in two after leaving the body to allow the typical two connections of hemodialysis treatment (e.g., blood out, filtered blood in). If the patient's disease has progressed rapidly, the patient may not have time to place an AV fistula or AV graft before starting hemodialysis treatment, as both typically require 2-3 months to develop / mature before being able to be used for hemodialysis; in this case, an intravenous catheter may be needed until more long-term vascular access is established.

[0010] Among the ways to create access for hemodialysis, an AV fistula is superior to the other types mentioned because it provides good blood flow for dialysis, it lasts longer, and is less likely to become infected or cause blood clots than other types of access. Although preferred, current practices for creating AV fistulas still have disadvantages. One of the main disadvantages includes the need for a vascular surgeon to surgically create an AV fistula, which requires appropriate personnel, facilities, and infrastructure to perform.

[0011] Newer methods for creating AV fistulas, such as by catheter electrocautery, etc., may allow for a more non-invasive approach, but they do not overcome all of the disadvantages of traditional surgical methods and may introduce new disadvantages. That is, due to the anatomical requirements of creating AV fistulas in adjacent blood vessels by catheter electrocautery methods, AV fistulas will be created between arteries and deep veins (rather than between arteries and direct superficial veins, which are the type of access veins required for hemodialysis). Although perforating veins do extend between deep veins and connect deep veins to superficial veins, deep veins also have multiple branching points in the anatomical regions typically used to create AV fistulas. Therefore, an AV fistula created by a catheter electrocautery method may disperse blood flow from an artery across multiple venous branches, and only a portion may be directed to the desired superficial vein, which may not be sufficient to induce the desired anatomical changes in the superficial veins as discussed above or to provide the desired blood flow for a hemodialysis treatment procedure. Secondary procedures such as band ligation and embolization of connected branch veins may be required to direct blood from the artery to the desired superficial vein, which delays the patient's availability of long-term vascular access and requires extended access via a venous catheter, subjecting the patient to the increased risks of this form of access. There remains a need for improved methods, systems, and devices for creating AV fistulas for hemodialysis. Summary of the invention

[0012] The embodiments disclosed herein each have several aspects, no single aspect of which is solely responsible for the desired attributes of the present disclosure. Without limiting the scope of the present disclosure, its more salient features will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled “Detailed Description of the Invention,” it will be understood how the features of the embodiments described herein provide advantages over existing systems, devices, and methods.

[0013] In some embodiments, disclosed herein is an implant configured for percutaneous delivery into a patient's arm for creating an arteriovenous fistula, the implant comprising: a proximal implant segment comprising a proximal end, a distal end, and an axis extending therethrough; a distal implant segment connected to the proximal implant segment, the distal implant segment comprising a proximal end, a distal end, and an axis extending therethrough; and a side opening located between the distal end of the proximal implant segment and the proximal end of the distal implant segment; wherein the proximal implant segment is configured to bend or flex at least 90 degrees relative to the distal implant segment in a direction away from the side opening.

[0014] In the above implant or in other embodiments as described herein, one or more of the following features can also be provided.In certain embodiments, the side opening is configured to allow blood (i) to flow from the distal end of the proximal implant section to the proximal end of the proximal implant section in a first direction along the proximal implant section, and (ii) to flow from the proximal end of the proximal implant section to the distal end of the proximal implant section in a second direction along the distal implant section.In certain embodiments, the proximal implant section can bend or bend at least 180 degrees in the direction away from the side opening relative to the distal implant section.In certain embodiments, the proximal implant section comprises a series of rows of pillars arranged circumferentially around the axis of the proximal implant section, and a series of rows of pillars of the proximal implant section are connected to each other by one or more axially extending pillars arranged roughly along the axis of the proximal implant section.In certain embodiments, the pillars of the adjacent rows of the proximal implant section are connected by no more than an axially extending pillar.In certain embodiments, each row of pillars comprises a row of wave pillars. In certain embodiments, the distal implant section comprises a series of rows of pillars arranged at least partially circumferentially around the axis of the distal implant section, and the series of rows of pillars of the distal implant section are connected to each other by one or more axially extending pillars arranged roughly along the axis of the distal implant section. In certain embodiments, a series of rows of pillars of the distal implant section are connected to each other by at least one pillar that is more axially extended than a series of rows of pillars of the proximal implant section, so as to provide the proximal implant section with respect to the greater flexibility of the distal implant section. In certain embodiments, most or all of one or more axially extending pillars of the proximal implant section are located on the side of the proximal implant section aligned with the position of the side opening. In certain embodiments, the proximal implant section has greater flexibility than the distal implant section. In certain embodiments, the proximal implant section includes a tubular body with a flow lumen extending between the proximal end of the proximal implant section and the distal end of the proximal implant section. In certain embodiments, the proximal implant section is linearly straight. In certain embodiments, the distal implant section includes at least a portion of a tubular body extending between its proximal end and its distal end. In certain embodiments, the distal implant section includes a tubular body with a flow lumen extending between the proximal end of the distal implant section and the distal end of the distal implant section. In certain embodiments, the distal implant section is linearly straight. In certain embodiments, the proximal implant section and the distal implant section include an expandable body, and wherein, when the proximal implant section and the distal implant section fully expand under static conditions, the proximal implant section is directed to be angled relative to the distal implant section. In certain embodiments, the axial length of the proximal implant section is greater than the axial length of the distal implant section. In certain embodiments, the distal end of the proximal implant section includes an anastomotic ring.In certain embodiments, one or both of the proximal implant section and the distal implant section include one or more anchors, and one or more anchors are configured to anchor one or both of the proximal implant section and the distal implant section by the wall of vein or artery. In certain embodiments, one or both of the proximal implant section and the distal implant section are covered with graft material. In certain embodiments, implant is configured to collapse to collapsed configuration, for percutaneous delivery to the arm of the patient, and is configured to expand to expanded configuration from collapsed configuration, for implantation between the patient's vein and artery. In certain embodiments, the proximal implant section and the distal implant section are formed by a single integral body. In certain embodiments, the proximal implant section and the distal implant section include a metal frame. In certain embodiments, the proximal implant section and the distal implant section are formed by a single laser cutting hypotube. In certain embodiments, implant further includes one or more axially extending pillars, and pillars connect the distal end of the proximal implant section to the proximal end of the distal implant section.

[0015] In some embodiments, disclosed herein is a method for creating an arteriovenous fistula in a patient, the method comprising: delivering an intraluminal implant in a collapsed configuration into the patient within a sheath, the sheath constraining the intraluminal implant at a distal end of the sheath, the intraluminal implant comprising a proximal implant segment and a distal implant segment, wherein the proximal implant segment is connected to the distal implant segment, wherein a portion of the distal end of the sheath is delivered into a proximal cavity of a nose cone of the patient, and wherein the nose cone comprises an angled proximal end, the angled proximal end comprising a proximal-most tip spaced radially outward from an inner diameter of the proximal cavity; extending the intraluminal implant within the sheath between a vein and an artery, wherein the intraluminal implant comprises a proximal implant segment and a distal implant segment. The invention relates to a method of implanting an implant having a proximal implant segment extending at least partially through one of a vein and an artery, and a distal implant segment and a nose cone being positioned within the other of the vein and the artery away from the proximal implant segment; proximally retracting the nose cone and the sheath so that the proximal tip of the nose cone engages the wall of the vein or artery in which the distal implant segment is positioned; proximally retracting the sheath relative to the nose cone to radially expand the proximal implant segment and engage the wall of the vein or artery in which the proximal implant segment extends; and advancing the nose cone distally relative to the distal implant segment to radially expand the distal implant segment and engage the wall of the vein or artery in which the distal implant segment is positioned.

[0016] In the above method or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the most proximal tip is radially spaced outward from the virtual projection of the inner diameter of the proximal cavity to form a radial gap between the virtual projection of the proximal tip and the inner diameter, the radial gap allowing the most proximal tip to engage the wall of the vein or artery in which the distal implant segment is positioned. In some embodiments, the proximal end of the nose cone comprises a first surface and a second surface in a longitudinal cross section, the first surface extending proximally and radially outwardly to the most proximal tip from the inner diameter of the proximal cavity, and the second surface extending distally and radially outwardly to the outer diameter of the nose cone from the most proximal tip. In some embodiments, the proximal implant segment radially expands to engage the wall of the vein, and the distal implant segment radially expands to engage the wall of the artery. In some embodiments, the intraluminal implant includes a side opening between the distal end of the proximal implant segment and the proximal end of the distal implant segment, so that after the proximal implant segment is radially expanded to engage the wall of the vein and the distal implant segment is radially expanded to engage the wall of the artery, blood flowing through the artery enters the side opening and (i) flows through the proximal end of the distal implant segment and the distal end of the distal implant segment to continue flowing through the artery, and (ii) flows through the distal end of the proximal implant segment and flows out of the proximal end of the proximal implant segment to flow into the vein. In some embodiments, the method further includes applying a reaction force to the patient when the sheath is retracted proximally relative to the nose cone to help maintain the engagement of the most proximal tip of the nose cone with the wall of the vein or artery while releasing the proximal implant segment from the sheath. In some embodiments, the reaction force is applied by a reaction force mechanism, which is configured to apply the reaction force against the patient's skin.

[0017] In some embodiments, disclosed herein is an intraluminal implant comprising one or more features as previously summarized or as further summarized and / or described herein.

[0018]

[0013] Disclosed herein, in some embodiments, is a delivery system for delivering an intraluminal implant comprising one or more features as summarized above or as further summarized and / or described herein.

[0019]

[0013] Disclosed herein, in some embodiments, is a method for delivering an intraluminal implant comprising one or more of the features summarized above or as further summarized and / or described herein.

[0020] Any of the embodiments summarized above or as further described in the detailed description may further or alternatively include the features of the systems, devices or methods summarized below.

[0021] In some embodiments, disclosed herein is a system for forming an arteriovenous fistula in a patient's arm, the system comprising: an intravascular delivery device configured to enter the patient's arm, wherein the intravascular delivery device is configured to be advanced into a superficial vein, a perforating vein, a deep vein, and an artery adjacent to the deep vein; and an intraluminal implant, wherein the intravascular delivery device is configured to carry the intraluminal implant into the patient's arm in a radially compressed configuration, the intraluminal implant comprising: a proximal implant segment comprising a proximal end and a distal end, the proximal implant segment being releasable from the intravascular delivery device to transition from a radially compressed configuration to a radially expanded configuration, in which the radially expanded configuration, A proximal implant segment extends through the perforator vein and the deep vein, wherein a proximal end of the proximal implant segment is positioned within the perforator vein; and a distal implant segment connected to the proximal implant segment, the distal implant segment being capable of being released from an intravascular delivery device to transition from a radially compressed configuration to a radially expanded configuration, in which the distal implant segment is positioned within an artery, wherein the distal side of the proximal implant segment is configured to be angled relative to an axis of the distal implant segment; wherein, when the proximal implant segment is in a radially expanded configuration extending through the perforator vein and the deep vein, and the distal implant segment is in a radially expanded configuration within the artery, the proximal implant segment is configured to deliver flow from the artery to the superficial vein.

[0022] In the above system or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the distal implant segment is configured to anchor against the wall of the artery. In some embodiments, the distal implant segment comprises a tubular body, which is configured to provide radial support to the artery. In some embodiments, the proximal implant segment comprises a tubular body configured to radially engage the wall of the perforator vein. In some embodiments, the distal end of the proximal implant segment is configured to be fixed to the wall of the artery. In some embodiments, the distal end of the proximal implant segment comprises an anchor configured to anchor against the arterial wall. In some embodiments, one or both of the proximal implant segment and the distal implant segment are covered with a graft material. In some embodiments, the implant includes a side opening between the distal end of the proximal implant section and the proximal end of the distal implant section, wherein, when the proximal implant section is in a radially expanded configuration extending through the perforator vein and the deep vein and the distal implant section is in a radially expanded configuration in the artery, the blood flowing through the artery enters the side opening, and (i) flows through the proximal end of the distal implant section and flows out of the distal end of the distal implant section, and (ii) flows through the distal end of the proximal implant section and flows out of the proximal end of the proximal implant section. In some embodiments, the distal end of the proximal implant section includes an anastomotic ring. In some embodiments, the distal end of the proximal implant section is configured to be about 0 degrees to about 90 degrees relative to the axis of the distal implant section. In some embodiments, the distal implant section is connected to the proximal implant section by at least one connecting pillar. In some embodiments, the delivery device includes a sheath, which is configured to constrain the intraluminal implant in a radial compression configuration in the distal end of the sheath. In some embodiments, the delivery device further includes a nose cone that can be advanced into the artery, and wherein the distal end of the sheath is configured to be inserted into the cavity of the nose cone for advancing into the artery with the nose cone. In some embodiments, the nose cone includes a tapered proximal end configured to engage the near wall of the artery. In some embodiments, the delivery device is configured so that, after the distal end of the sheath advances into the artery with the nose cone: the sheath can be retracted in a proximal direction relative to the nose cone to expand the proximal implant segment in the deep vein and the perforator vein; and after the proximal implant segment is expanded in the deep vein and the perforator vein to expand the distal implant segment in the artery, the nose cone can advance distally relative to the distal implant segment. In some embodiments, the delivery device is configured so that, after the distal implant segment is expanded in the artery, the sheath can advance through the expanded proximal implant segment, and the expanded distal implant segment engages with the nose cone, so as to facilitate the removal of the nose cone from the artery using the sheath. In some embodiments, the delivery device further comprises a guidewire shaft configured to advance over the guidewire, wherein the nose cone is secured to the guidewire shaft.

[0023] In some embodiments, disclosed herein is a method for forming an arteriovenous fistula in an arm of a patient, the method comprising: delivering an intraluminal implant in a collapsed configuration into the patient's body, the intraluminal implant comprising a proximal implant segment and a distal implant segment, wherein the proximal implant segment is connected to the distal implant segment; extending the intraluminal implant between a deep vein and an artery adjacent to the deep vein, wherein the proximal implant segment extends through a perforator vein, and the deep vein and the distal implant segment are positioned within the artery; and radially expanding the proximal implant segment so that the proximal implant segment engages a wall of the perforator vein, and radially expanding the distal implant segment so that the distal implant segment engages a wall of the artery and provides radial support to the artery, so that blood flowing through the artery is delivered from the artery to a superficial vein connected to the perforator vein.

[0024] In the above method or in other embodiments as described herein, one or more features in the following features can also be provided.In certain embodiments, the intraluminal implant is included in the side opening between the distal end of the proximal implant section and the proximal end of the distal implant section, so that after the proximal implant section is radially expanded to engage the wall of the perforator vein, and the distal implant section is radially expanded to engage the wall of the artery, the blood flowing through the artery enters the side opening, and (i) flows through the proximal end of the distal implant section and the distal end of the distal implant section to continue to flow through the artery, and (ii) flows through the distal end of the proximal implant section and flows out of the proximal end of the proximal implant section to flow into the perforator vein and flow into the superficial vein.In certain embodiments, the proximal implant section and the distal implant section comprise a tubular body.In certain embodiments, the method further comprises anchoring the distal end of the proximal implant section to the wall of the artery. In some embodiments, after the proximal implant segment radially expands to engage the wall of the perforator vein, and the distal implant segment radially expands to engage the wall of the artery, the proximal implant segment is angled relative to the axis of the distal implant segment. In some embodiments, the proximal implant segment is angled relative to the axis of the distal implant segment between about 0 degrees and about 90 degrees. In some embodiments, the intraluminal implant is delivered into the patient's body within the sheath, and the sheath constrains the intraluminal implant to the distal side of the sheath. In some embodiments, the distal end of the sheath advances into the artery in the cavity of the nose cone. In some embodiments, by retracting the sheath proximally relative to the nose cone, the proximal implant segment is released from the sheath to radially expand to engage with the wall of the perforator vein. In some embodiments, by advancing the nose cone distally relative to the distal implant segment, the distal implant segment is radially expanded to engage with the arterial wall. In some embodiments, the method further includes advancing the sheath distally through the radially expanded proximal implant segment and the radially expanded distal implant segment to engage with the nose cone, and retracting the sheath engaged with the nose cone proximally through the radially expanded proximal implant segment and the radially expanded distal implant segment. In some embodiments, the nose cone includes a tapered proximal side that engages with the wall of the artery when the sheath is retracted proximally to release the proximal implant segment. In some embodiments, the nose cone is rotated within the artery after the nose cone has been advanced distally to release the distal implant segment and before the sheath engaged with the nose cone is retracted proximally through the radially expanded proximal implant segment and the radially expanded distal implant segment.

[0025] In some embodiments, disclosed herein is a method for creating an arteriovenous fistula, the method comprising: accessing a superficial vein; advancing an access tool into the superficial vein, into the perforating vein, and into the deep vein; advancing the access tool through the luminal wall of the deep vein, through one or any interstitial space, and through the adventitia wall of the artery (sometimes also referred to herein as the "deep artery"); advancing a guidewire through the access tool into the artery; retracting the access tool over the guidewire; and / or advancing a device (also referred to herein as a "delivery device") over the guidewire so that the distal end of the device is within the artery and a more proximal end segment of the device spans the or any interstitial space.

[0026] In the above method or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the method may include, wherein, advancing the entry tool through the lumen wall of the deep vein, through the or any interstitial space and through the adventitia wall of the artery includes actuating a port close to the proximal end of the entry tool, thereby causing a sharp needle tip to extend distally from the distal end of the entry tool. In some embodiments, the actuation port includes depressing the port and compressing a spring element operably connected to the sharp needle. In some embodiments, the method further includes releasing the port, thereby allowing the spring element to recoil and causing the sharp needle tip to retract proximally into the distal end of the entry tool. In some embodiments, the device or delivery device includes a nose cone. In some embodiments, the nose cone includes a proximal tapered end cloth, a central lumen, a distal tapered end, and a longitudinal axis. In some embodiments, the device or delivery device includes a flexible sheath, which includes a longitudinal axis. In some embodiments, the implant is carried in a flexible sheath in a radially compressed configuration. In some embodiments, after advancing the device or delivery device along the guidewire, the distal side of the flexible sheath is located within the central lumen of the nose cone, and when the flexible sheath enters the central lumen of the nose cone at the proximal tapered end of the nose cone, a gap is formed between the proximal tapered end of the nose cone and the side wall of the flexible sheath, and wherein the longitudinal axis of the flexible sheath is not coaxial with the longitudinal axis of the nose cone. In some embodiments, the length of the gap is between about 5% and about 50% of the diameter of the proximal tapered end of the nose cone. In some embodiments, no gap is formed and / or required between the proximal tapered end of the nose cone and the side wall of the flexible sheath. In some embodiments, the method further includes retracting the nose cone and the flexible sheath proximally so that the nose cone engages the proximal wall of the artery. In some embodiments, the method further includes retracting the sheath proximally, thereby allowing the proximal end segment of the implant to transition from a radially compressed configuration to a radially expanded configuration. In some embodiments, retracting the sheath proximally releases an anchor that engages the proximal end segment of the implant relative to the proximal wall of the artery. In some embodiments, the distal segment of the implant is retained within the nose cone in a radially compressed configuration, while the proximal end segment of the implant is in a radially expanded configuration. In some embodiments, the method further includes advancing the nose cone relative to the distal segment of the implant, thereby transforming the distal segment of the implant into a radially expanded configuration. In some embodiments, advancing the nose cone releases an anchor that engages the proximal end segment of the implant relative to the near wall of the artery. In some embodiments, retracting the sheath proximally releases an anchor that engages the proximal end segment of the implant relative to the near wall of the artery. In some embodiments, the method further includes advancing the sheath distally through the distal segment of the implant in a radially expanded configuration, thereby engaging the nose cone. In some embodiments, the method further includes rotating the nose cone about its longitudinal axis.In some embodiments, the method further comprises retracting the nose cone and the flexible sheath proximally into the artery, the or any interstitial space, the deep vein, the perforating vein, and the superficial vein, thereby leaving the implant in place.

[0027] In some embodiments, disclosed herein is a method for creating a fistula, the method comprising: advancing an access tool through a wall of a first cavity, through one or any interstitial space, and through an outer wall of a second cavity; advancing a guidewire through the access tool into the second cavity; retracting the access tool over the guidewire; and / or advancing a device (also referred to herein as a "delivery device") over the guidewire so that a distal end of the device is within the second cavity and a more proximal end segment of the device spans the or any interstitial space, wherein the device comprises a nose cone and a flexible sheath, the nose cone comprising a proximal tapered end, a central cavity, a distal tapered end, and a longitudinal axis, the flexible sheath comprising a longitudinal axis, wherein, after advancing the device over the guidewire, the distal end of the flexible sheath is located within the central cavity of the nose cone, and when the flexible sheath enters the central cavity of the nose cone at the proximal tapered end of the nose cone, a gap is formed between the proximal tapered end of the nose cone and the side wall of the flexible sheath, and wherein the longitudinal axis of the flexible sheath is not coaxial with the longitudinal axis of the nose cone.

[0028] In the above method or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the length of the gap is between about 5% and about 50% of the diameter of the proximal tapered end of the nose cone. In some embodiments, the gap is formed at least in part by deflecting the nose cone relative to the flexible sheath. In some embodiments, no gap is formed and / or required between the proximal tapered end of the nose cone and the sidewall of the flexible sheath. In some embodiments, deflecting the nose cone includes actuating at least one pull wire. In some embodiments, the method further includes retracting the nose cone and the flexible sheath proximally so that the nose cone engages the proximal wall of the second inner cavity. In some embodiments, the implant is carried in the flexible sheath in a radially compressed configuration. In some embodiments, the method further includes retracting the sheath proximally, thereby allowing the proximal end segment of the implant to transition from the radially compressed configuration to the radially expanded configuration. In some embodiments, retracting the sheath proximally releases an anchor that engages the proximal end segment of the implant relative to the proximal wall of the second cavity. In some embodiments, the distal segment of the implant remains in the nose cone in the radially compressed configuration, while the proximal end segment of the implant is in the radially expanded configuration. In some embodiments, the method further comprises advancing the nose cone relative to the distal section of the implant, thereby transforming the distal section of the implant into a radially expanded configuration. In some embodiments, advancing the nose cone releases an anchor that engages the proximal end section of the implant relative to the proximal wall of the second cavity.

[0029] In some embodiments, disclosed herein is an intraluminal delivery system or device, comprising: a nose cone, the nose cone comprising a proximal tapered end, a central lumen, a distal tapered end and a longitudinal axis, and a flexible sheath, the flexible sheath comprising a longitudinal axis, wherein the device is configured such that the distal end of the flexible sheath is configured to be located within the central lumen of the nose cone, so that when the longitudinal axis of the flexible sheath is not coaxial with the longitudinal axis of the nose cone, a gap is formed between the proximal tapered end of the nose cone and the side wall of the flexible sheath when entering the central lumen of the nose cone at the proximal tapered end of the nose cone.

[0030] In the above systems or devices or in other embodiments described herein, one or more of the following features may also be provided. In some embodiments, the nose cone includes a slit. In some embodiments, the slit is on the proximal tapered end of the nose cone. In some embodiments, no gap is formed and / or required between the proximal tapered end of the nose cone and the sidewall of the flexible sheath.

[0031] In some embodiments, disclosed herein is an intraluminal implant comprising: a proximal implant segment, a distal implant segment, and at least one axially-oriented connecting strut connecting the proximal implant segment and the distal implant segment, the proximal implant segment and the distal implant segment comprising a flow lumen passing therethrough, wherein at least one axially-oriented connecting strut serves as the only connection between the proximal implant segment and the distal implant segment, wherein the axial length of the proximal implant segment is greater than the axial length of the distal implant segment, and wherein the implant comprises a shape memory material.

[0032] In the above implant or in other embodiments as described herein, one or more of the following features can also be provided.In certain embodiments, the implant is configured so that when the implant is in a non-stressed state, the distal implant section comprises a diameter different from the diameter of the proximal implant section.In certain embodiments, the implant is configured so that when the implant is in a non-stressed state, the diameter that the distal implant section comprises is less than the diameter of the proximal implant section.In certain embodiments, the implant is configured so that when the implant is in a non-stressed state, the distal implant section comprises a periphery different from the periphery of the proximal implant section.In certain embodiments, the implant is configured so that when the implant is in a non-stressed state, the distal implant section comprises a periphery less than the periphery of the proximal implant section.In certain embodiments, the implant is configured so that when the implant is in a non-stressed state, the distal implant section comprises a cross-sectional area different from the cross-sectional area of ​​the proximal implant section. In some embodiments, the implant is configured so that when the implant is in a non-stressed state, the distal implant section includes a cross-sectional area that is less than the cross-sectional area of ​​the proximal implant section. In some embodiments, the implant is configured so that when the implant is in a non-stressed state, the proximal implant section includes a variable diameter and / or cross-sectional area. In some embodiments, the implant is configured so that the distal edge of the proximal implant section includes a continuous pillar and / or ring. In some embodiments, the implant is configured so that the distal edge of the proximal implant section includes a continuous pillar and / or ring with one or more anchors. In some embodiments, the implant is configured so that the proximal implant section includes a pillar of uniform length. In some embodiments, the implant is configured so that the proximal implant section includes a pillar of variable length and / or variable width. In some embodiments, the implant is configured so that the proximal implant section includes a pillar with a length different from the length of the pillar of the distal implant section. In some embodiments, the implant is configured so that when the implant is in a non-stressed state, the distal implant section is longitudinally offset from the proximal implant section. In some embodiments, the proximal implant section comprises a biocompatible graft material. In some embodiments, the distal implant section comprises a biodegradable graft material. In some embodiments, the implant comprises a porous or non-porous laminate layer. In some embodiments, the implant comprises a coating containing heparin and / or a therapeutic agent.

[0033] In some embodiments, disclosed herein is an intraluminal implant for creating an arteriovenous fistula, comprising: a proximal implant segment, the proximal implant segment comprising a proximal end and a distal end, the proximal implant segment being configured to extend through a perforator vein and a deep vein, wherein the proximal end of the proximal implant segment is configured to be positioned within the perforator vein; and a distal implant segment connected to the proximal implant segment and configured to be positioned within an artery adjacent to the deep vein, wherein the distal end of the proximal implant segment is configured to be angled relative to an axis of the distal implant segment; wherein the proximal implant segment is configured to deliver flow from the artery to a superficial vein connected to the perforator vein.

[0034] In the above implant or in other embodiments as described herein, one or more of the following features can also be provided.In certain embodiments, the proximal implant section and the distal implant section comprise expandable tubular body.In certain embodiments, the intraluminal implant is included in the side opening between the distal end of the proximal implant section and the proximal end of the distal implant section, so that the blood flowing through the artery enters the side opening, and (i) flows through the proximal end of the distal implant section and flows out from the distal end of the distal implant section, to continue to pass this artery, and (ii) flows through the distal end of the proximal implant section and flows out from the proximal end of the proximal implant section to flow into the perforator vein and flow into the superficial vein.In certain embodiments, the proximal implant section is about 0 to about 90 degrees angle relative to the axis of the distal implant section.

[0035] In some embodiments, disclosed herein is an intraluminal implant for creating an arteriovenous fistula, comprising: a venous implant segment, the venous implant segment comprising a first expandable tubular body having a first end and a second end and a lumen extending therethrough, wherein the first expandable tubular body is configured to collapse for delivery into a patient and is expandable to radially engage an inner wall of a vein; and an arterial implant segment, the arterial implant segment comprising a second expandable tubular body having a first end and a second end and a lumen extending therethrough, wherein the second expandable tubular body is configured to collapse for delivery into a patient and is expandable to radially engage an inner wall of an artery positioned adjacent to the vein; wherein the venous implant segment The second end is connected to the first end of the arterial implant segment to allow the arterial implant segment to be angled relative to the venous implant segment when the venous implant segment and the arterial implant segment are in an expanded configuration, and wherein the angle of the arterial implant segment relative to the venous implant segment increases the distance between the second end of the venous implant segment and the first end of the arterial implant segment along a side of the implant to provide a side opening into the implant; and wherein, when the venous implant segment radially engages the inner wall of the vein and the arterial implant segment radially engages the inner wall of an artery adjacent to the vein, blood flowing through the artery enters the side opening and (i) flows through the first end of the arterial implant segment and out of the second end of the arterial implant segment, and (ii) flows through the second end of the venous implant and out of the first end of the venous implant segment.

[0036] In some embodiments, disclosed herein is a delivery device for delivering a vascular implant between a vein and an artery, the delivery device comprising: an outer sheath configured to constrain the implant in a low-profile configuration at the distal end of the outer sheath; and a nose cone comprising a proximal end and a distal end and a cavity, wherein the distal end of the outer sheath is insertable into the cavity to allow the nose cone and the outer sheath to advance distally through the vein and into the artery; wherein the outer sheath is retractable in a proximal direction relative to the nose cone to allow a distal segment of the implant to expand within the cavity; wherein the outer sheath is further retractable in a proximal direction relative to the nose cone to allow a proximal end segment of the implant to expand within the vein; and wherein, after the proximal end segment expands within the vein to release the distal segment of the implant from the cavity within the artery, the nose cone is advanceable distally relative to the distal segment of the implant.

[0037] In the above device or in other embodiments as described herein, one or more of the following features may also be provided. In some embodiments, the distal end of the nose cone is tapered. In some embodiments, the proximal end of the nose cone is tapered. In some embodiments, the proximal end of the nose cone is angled relative to the longitudinal length of the nose cone. In some embodiments, the tapered proximal end of the nose cone is configured to engage the near wall of the artery after the nose cone advances into the artery. In some embodiments, the distal end of the outer sheath may advance through the distal segment of the implant and enter the cavity after the distal segment of the implant is released in the artery. In some embodiments, the distal end of the outer sheath may advance through the distal segment of the implant after the distal segment of the implant is released in the artery to engage the proximal end of the nose cone so that the nose cone enters the distal end of the outer sheath. In some embodiments, the delivery device further includes a guidewire shaft configured to advance on a guidewire, wherein the nose cone is fixed to the guidewire shaft. In some embodiments, the delivery device further includes a control knob connected to the proximal end of the outer sheath, configured to retract and / or advance the outer sheath when the proximal and / or distal movement of the control knob, the control knob being at least partially arranged in the handle of the delivery device. In some embodiments, the control knob is configured to releasably lock into the most proximal position and / or the most distal position in the handle. In some embodiments, the delivery device further includes an intermediate shaft in the outer sheath, the intermediate shaft being configured to prevent the implant from sliding proximally during the retraction of the outer sheath. In some embodiments, when the outer sheath advances into the cavity, the distal end of the intermediate shaft guides the distal end of the outer sheath. In some embodiments, the delivery device further includes an intermediate shaft connector, the intermediate shaft connector being arranged in the handle and connected to the proximal side of the intermediate shaft, the intermediate shaft connector being configured to engage with the control knob and cause the intermediate shaft to advance with the outer sheath when the outer sheath is advanced into the cavity. In some embodiments, the implant is constrained in the distal end of the outer sheath.

[0038] In some embodiments, disclosed herein is a method for creating an arteriovenous fistula between an artery and a vein of a patient, the method comprising: delivering an intraluminal implant in a collapsed configuration into the patient, the intraluminal implant comprising a venous implant segment and an arterial implant segment, the venous implant segment comprising a first tubular body, the arterial implant segment comprising a second tubular body, wherein the venous implant segment is connected to the arterial implant segment; extending the intraluminal implant across any interstitial space between the artery and the vein; and radially expanding the venous implant segment to radially engage the vein and radially expanding the arterial implant segment to radially engage the artery; wherein, when the venous and arterial implant segments are radially engaged with the vein and the artery, respectively, the arterial implant segment is angled relative to the venous implant segment to provide a side opening into the intraluminal implant, the side opening allowing blood flowing through the artery to enter the side opening and (i) flow through the second tubular body of the arterial implant segment to continue through the artery, and (ii) flow through the first tubular body of the venous implant segment to flow into the vein.

[0039] In some embodiments, disclosed herein is an intraluminal implant including an implant framework. The implant framework may include a pillar. The implant framework may be covered by an inner layer of a porous graft material (such as ePTFE, etc.) and an outer layer of a porous graft material (such as ePTFE, etc.). The inner layer and the outer layer may be fused to encapsulate the implant framework. A thermoplastic laminate may be placed between the inner layer and the outer layer of the porous graft material to promote the combination of the inner layer and the outer layer. The thermoplastic laminate may be placed on the outer surface of the implant framework, and the outer layer of the porous graft material may be applied to the thermoplastic laminate. The thermoplastic laminate may be non-porous. In some embodiments, the thermoplastic laminate may include a strip spirally wound between the inner layer and the outer layer. The thermoplastic laminate may include a fluorinated ethylene propylene (FEP), polyethylene (PE) or a thermoplastic polyurethane (TPU) film. In some embodiments, the thermoplastic laminate may be wrapped to leave a gap between each wrapping of the thermoplastic laminate. In the embodiment comprising the proximal implant section and the distal implant section as described in other various places of this paper, the gap can be provided along at least the proximal end portion of the proximal implant section, to provide extra flexibility to the proximal implant section. In certain embodiments, the distal end along the proximal implant section does not provide a gap, and / or does not provide a gap along the distal implant section.

[0040]

[0013] Disclosed herein, in some embodiments, is a method, system, or apparatus comprising, consisting essentially of, consisting of, and / or excluding any number of the features of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The foregoing and other features, aspects, and advantages of embodiments of the systems, devices, and methods described herein are described in detail below with reference to the accompanying drawings of various embodiments, which are intended to illustrate, but not limit, embodiments of the invention. The drawings include the following drawings, in which:

[0042] Figure 1 Depicted is a simplified representation of a portion of the vasculature of a human arm indicating potential areas for creating an anastomotic connection in accordance with some embodiments.

[0043] Figure 2A-2D Methods of percutaneously introducing an intravascular guidewire are described in accordance with some embodiments.

[0044] Figure 3-Figure 15 Methods of percutaneously implanting an intravascular implant are described according to some embodiments.

[0045] Figure 16A-16C An intravascular implant according to some embodiments is depicted.

[0046] Fig.16D Depicted is a stack-up of implant frames according to some embodiments.

[0047] FIG. 17A to FIG. 17I An intravascular implant according to some embodiments is depicted.

[0048] 18A to 18D An intravascular implant according to some embodiments is depicted.

[0049] FIG. 19A to FIG. 19B An intravascular implant according to some embodiments is depicted.

[0050] Figure 20A-20C An intravascular implant according to some embodiments is depicted.

[0051] Fig.21 Depicted are partial cross-sectional views of various elements of a delivery system according to some embodiments.

[0052] Figure 22A-22B Depicted are various views of a nose cone of a delivery system according to some embodiments.

[0053] Fig.23A Depicted is a perspective view of a handle of a delivery system according to some embodiments.

[0054] Fig. 23B Depicted is a cross-sectional view of a handle of a delivery system according to some embodiments.

[0055] Fig.24A Depicted is a perspective view of a delivery system according to some embodiments.

[0056] Fig. 24BDepicted is a perspective cross-sectional view of a delivery system according to some embodiments.

[0057] Fig.24C Depicted is an exploded perspective view of a delivery system according to some embodiments.

[0058] Fig.24D Depicted is a cross-sectional view of a distal end of a delivery system according to some embodiments.

[0059] Fig.24E Depicted is a perspective view of a delivery system with a portion of a handle housing of the delivery system removed from view, according to some embodiments.

[0060] Fig.24F Depicted is a side view of a distal end of a delivery system according to some embodiments.

[0061] Figure 24G Depicted is a perspective view of a delivery system carrying an implant in its radially compressed configuration, according to some embodiments.

[0062] Fig.24H Depicted according to some embodiments Figure 24G An enlarged view of the distal end of a delivery system including an implant in its radially compressed configuration.

[0063] Fig.25 Depicted is a simplified representation of a portion of the human vasculature indicating potential areas for creating an anastomotic connection in accordance with some embodiments.

[0064] Figure 26 to Figure 29 Methods of percutaneously introducing an intravascular guidewire are described in accordance with some embodiments.

[0065] Figure 30-Figure 40 Methods of percutaneously implanting an intravascular implant are described according to some embodiments.

[0066] Fig.41 Methods of bypassing a segment of an artery using an intravascular implant are described in accordance with some embodiments.

[0067] Fig.42 Reaction force mechanisms and methods of using the same are depicted in accordance with some embodiments.

[0068] Throughout the drawings, reference numerals may be re-used to indicate a general correspondence between referenced elements unless otherwise noted.The drawings are provided to illustrate exemplary embodiments described herein and are not intended to limit the scope of the present disclosure. DETAILED DESCRIPTION

[0069] Embodiments disclosed herein generally relate to medical devices and methods. More specifically, some embodiments relate to intravascular implants and methods and devices for effectively and accurately placing them in vascular systems. In some embodiments, the devices, methods, and systems described herein allow for precise placement of devices (such as stents, including covered stents) and other implants and anastomotic devices for creating arteriovenous fistulas (AVFs) while minimizing or eliminating the need for radiographic imaging, thereby allowing them to be performed in a clinical setting using only non-invasive imaging techniques (such as percutaneous ultrasound (e.g., high-resolution ultrasound systems, such as high-frequency linear transducers (about 9-15MHz)). Some embodiments utilize novel devices for temporarily engaging anatomical structures when delivering intravascular implants. In addition, in some embodiments, the implants, devices, systems, and / or methods described herein advantageously overcome some or all of the disadvantages of existing implants, devices, systems, and / or methods for creating AVFs, including bypassing deep vein branches that may undesirably deliver arterial blood flow away from the desired superficial veins, and preventing or reducing secondary surgeries such as ligation and embolization.

[0070] Figure 1 A simplified representation of a portion of the vasculature of a human arm having a skin surface (e.g., dermal surface 28) is depicted. Location 7 is a potential area for forming an anastomotic connection between a first lumen and a second lumen (e.g., an artery and a vein, such as an AVF between a deep vein 3 and an adjacent deep artery 4). An anastomotic vein 2 connects a superficial vein 1 to a deep vein 3, which is located near location 7 and provides a conduit for accessing location 7. An AVF can be made between an anastomotic vein 2 and an artery 4, bypassing the deep vein 3. In some embodiments, the AVF between an anastomotic vein 2 and an artery 4 can deliver blood from the artery to a superficial vein 1 connected to an anastomotic vein 2.

[0071] Figure 2A , Figure 2B , Figure 2C as well as Figure 2D Some embodiments of a method of percutaneously introducing an intravascular guidewire 5 into a deep artery 4 using a needle access tool 35 are depicted. An example of an intravascular guidewire 5 may have a diameter of about 0.018 inches and a length of about 80 cm. An example of a suitable guidewire 5 is (Medtronic) 5 cm angled tip #N180802. The needle access tool 35 may include a hollow needle having a proximal port 30 slidably disposed within a sheath 33 and a distal sharp tip 34. The hollow needle may be an echogenic needle, such as an echogenic 21g needle. The hollow needle may have a length of about 7 cm. An example of a suitable needle is (Cook ) Group #G43869. The sheath 33 is connected to the hub 32, which has a compression element, such as a compression spring 31, placed between the port 30 and the hub 32. When the port 30 is depressed, the needle tip 34 is exposed distally at the distal end of the sheath 33 and is able to pierce tissue such as skin and blood vessels. When the port 30 is not depressed, the spring 31 will decompress and move the needle tip 34 proximally so that it is not exposed. In this configuration, the needle access device can be advanced in the vasculature, reducing the risk of inadvertent punctures and trauma to the vasculature. Using this feature of the needle access tool 35 and an appropriate imaging technique, such as transcutaneous ultrasound, the needle access tool is first introduced into the superficial vein 1, as shown. Figure 2A When the needle tip 34 is retracted within the sheath 33, the needle entry tool is used as shown. Figure 2B Appropriate imaging is shown to navigate to position 7. At position 7, the proximal port 30 is actuated (e.g., depressed) to expose the needle tip 34, and the needle entry tool 35 is then advanced to penetrate the vessel wall and any interstitial tissue between the deep vein 3 and the deep artery 4 until the distal end of the sheath 33 enters the lumen of the deep artery 4. While maintaining this position, the guide wire 5 is introduced into the proximal port 30 and advanced through the needle entry tool 35 until the distal end of the guide wire 5 leaves the distal end of the needle entry tool 35 and enters the lumen of the deep artery 4, as shown. Figure 2C shown. Figure 2D A guidewire 5 with a curvature 6 formed when the guidewire 5 conforms to a specific vascular anatomy is shown. The needle entry tool 35 may have an alternative embodiment, which may include a curved distal end to allow easier navigation through the vascular system, a hemostatic valve attached to the proximal port 30, and a spring-loaded hollow needle that can help pierce a mobile structure. Alternative sites may also be selected to create an AVF at position 7. For example, if the distance between the deep vein 3 and the deep artery 4 is less than the distance at position 7, a further position along the deep vein 3 may prove more advantageous. Some embodiments are not limited to the connection between the deep vein and the deep artery, such as in the upper or lower extremities, such as in the hand, forearm, arm, foot, calf, thigh, or other regions. Some embodiments can be used to precisely position implants in other luminal structures, such as superficial veins and arteries, coronary arteries, gynecological structures (e.g., vagina, cervix, uterus, or fallopian tubes), urinary tract structures (e.g., ureters, bladder, or urethra), and gastrointestinal structures (e.g., esophagus, stomach, small intestine, large intestine, rectum, biliary tree, etc.), among others.

[0072] Figure 3The distal end of an intravascular delivery system 29 is depicted, the intravascular delivery system 29 having a distal nose cone 8 with a distal taper 10, a cavity 9 (e.g., a central lumen), and a tapered proximal end 11 that is introduced into the vascular system and approaches the AVF location 7 through a guidewire 5 having a curvature 6. An outer sheath 12 is shown to constrain an implant 13 in a low profile (e.g., collapsed) configuration, wherein the distal end of the outer sheath 12 is inserted into the cavity 9. The delivery system 29 is shown to have a shape that conforms to the bend of the guidewire 5 and the vascular anatomy. The delivery system 29 can be flexible or relatively rigid compared to the surrounding vascular structure and the guidewire 5. The nose cone 8 has a distal taper 10 so that it can more easily penetrate the vessel wall and any interstitial tissue at the AVF location 7. In one embodiment, the distal-most side of the distal taper 10 can have a sharp point to further facilitate penetration of various tissues. The nose cone 8 has features to accommodate the guidewire 5 and in this embodiment is coupled or otherwise secured to the inner guidewire shaft 22, such as Figure 8 shown, but in Figure 3 Not shown in FIG.

[0073] Figure 4 The nose cone 8 of the delivery system 29 is depicted traversing the AVF site 7 and advancing within the deep artery 4. The intermediate shaft 16 is shown as being slidably disposed within the outer sheath 12. The intermediate shaft 16 is slidably disposed around the guidewire shaft 22, which is Figure 4 14 is not shown. A gap 14 is also depicted, which can be formed when the delivery system 29 follows the guidewire curvature 6 and the nose cone 8 and the outer sheath 12 are no longer coaxial. The gap 14 can be defined in some embodiments as an open space between the proximal opening of the nose cone 8 and the side wall of the outer sheath 12 when the outer sheath 12 enters the proximal opening of the nose cone 8. In some embodiments, the gap defines a length and / or diameter of about, at least about, or no more than about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50% or more or less, or a range including any two of the foregoing values, of the corresponding length and / or diameter of the proximal opening of the nose cone 8. In some embodiments, no gap is formed and / or required between the proximal opening of the nose cone 8 and the side wall of the outer sheath 12.

[0074] When the distal end of the delivery system 29 is in a curved configuration in which the proximal end of the tapered proximal end 11 is on the outside of the curve, as shown in FIG. Figure 4As shown, an angle 15 between the central (e.g., longitudinal) axis of the nose cone 8 and the central (e.g., longitudinal) axis of the outer sheath 12 can be formed. In some embodiments, the angle 15 can be, for example, about, at least about, or not more than about 5, 10, 15, 20, 25, 30, 35, 40, 45 degrees or more or less, and a range including any two of the aforementioned values. In order to promote greater flexibility between the nose cone 8 and the outer sheath 12, the nose cone 8 can have a slit in the wall forming the cavity 9. In some embodiments, the curvature of the guide wire 5 can be used to form the angle 15 and thus form the gap 14. Alternative devices for forming the angle 15 and the gap 14 can be used. Alternative embodiments can be, for example, using one, two or more pull wires to deflect the distal end of the delivery system 29, thereby forming the gap 14. Depending on the desired clinical results, a variety of manipulable and / or deflectable elements can be utilized. In some cases, the gap 14 can be formed by the difference between the outer diameter of the outer sheath 12 and the inner diameter of the cavity 9 of the nose cone 8.

[0075] Figure 5 Depicted is a delivery system 29 that has been removed from its Figure 4 The nose cone 8 engages the near wall of the deep artery 4 after being pulled proximally from the position in the delivery system 29. The engagement between the nose cone 8 and the near wall of the deep artery 4 can be attributed to the gap 14, which can be formed when the delivery system 29 is pushed into a curved configuration, wherein the proximal end of the tapered proximal end 11 is located outside the curve. In some embodiments, the nose cone 8 can engage the near wall of the artery without the need for the gap 14. For example, the proximal end of the tapered proximal end 11 can be formed by, for example, using the first surface 64 ( Fig. 22B ) engages the proximal wall of the deep artery 4 to engage the proximal wall of the artery 4 without a gap 14 between the tapered proximal end 11 and the outer sheath 12. Also depicted is the deformation of the anatomical structure at the AVF location 7, which is a result of the juxtaposition forces between the proximal wall of the deep artery 4 and the tapered proximal end 11 of the nose cone 8. This deformation of the anatomical structure at the AVF location 7 can be visualized by ultrasound and used to verify proper tissue engagement and / or implant placement prior to delivery. One way to visualize this engagement and ensure that the nose cone 8 is properly oriented during the deployment of the implant 13 by ultrasound is by using a long axis view that includes the perforator vein 2 and the deep artery 4 along its length.

[0076] Fig. 6ADepicted are initial steps of a first stage of delivery of an elastically constrained (e.g., collapsed) implant 13 according to some embodiments. As the nose cone 8 remains juxtaposed against the proximal wall of the deep artery 4, the outer sheath 12 is retracted proximally, allowing the elastically constrained (e.g., collapsed) implant 13 to expand to a precise position defined by the engagement between the nose cone 8 and the proximal wall of the deep artery 4. The distal end of the intermediate shaft 16 remains fixed during delivery so that the elastically constrained (e.g., collapsed) implant 13 does not slide proximally during retraction of the outer sheath 12. Also depicted is the distal implant segment 18 being partially retained (e.g., partially collapsed) by the cavity 9. The distal implant segment 18 is connected to the connector strut 20, which can be axially oriented, for example as shown. Fig. 6A The proximal implant section 19 has not yet been fully released (eg, expanded). One or more anchors 17 are also partially constrained (eg, partially collapsed) in the cavity 9. Fig. 6A Depicted in FIG is the radial expansion at the AVF location 7 due to the radial stiffness of the elastically expandable implant 13. The distal end of the proximal implant segment 19 can be angled relative to the axis of the distal implant segment 18 of the implant so that it does not block the deep artery 4 while still being completely within and supporting the region between the vessel walls of the deep vein 3 and the deep artery 4. In some embodiments, the distal end of the proximal implant segment 19 can be angled relative to the axis of the distal implant segment 18 between about 0 degrees and about 90 degrees.

[0077] In some embodiments, and as Figure 6B As shown, the proximal retraction of the outer sheath 12 can release one or more anchors 17. The anchors 17 can engage the proximal wall of the deep artery 4 (e.g., Figure 6B As shown), the wall of the deep vein 3, the wall of the perforating vein 2, the wall of the superficial vein 1, and / or any interstitial tissue. In some embodiments, the anchor 17 may include a proximal anchor that extends proximally after being unconstrained (e.g., expanded or released). In one example, as described below, one or more anchors 17 can extend from the distal end of the proximal implant segment 19 in a distal direction while being constrained by the outer sheath 12 or the nose cone 8. After the outer sheath 12 is retracted, the anchor 17 can move to an expanded (e.g., unconstrained or released) configuration, wherein the anchor extends radially outward and bends or bends in the proximal direction to facilitate engagement with the vessel wall or interstitial tissue. In other examples, such as the following 18A to 18C As shown, the anchor can extend in the proximal direction while constrained by the outer sheath 12 or nose cone 8, and when unconstrained.

[0078] Fig. 7A follow Fig. 6AAnd continued delivery (eg, expansion) of the elastically constrained (eg, collapsed) implant 13 is shown as the outer sheath 12 is further retracted until the proximal implant segment 19 is fully released (eg, expanded) from the outer sheath 12 . Figure 7B then Figure 6B And depicted is continued delivery (eg, expansion) of the elastically constrained (eg, collapsed) implant 13 as the outer sheath 12 is further retracted until the proximal implant segment 19 is fully released (eg, expanded) from the outer sheath 12 .

[0079] Figure 8 The delivery of the distal implant segment 18 of the implant 13 is depicted, and in some embodiments, the release of the anchor 17 is shown. As the nose cone 8 is advanced distally by advancing the guidewire shaft 22 distally, the distal implant segment 18 is maintained in its axial position by the connector struts 20 and is thus slidably released from the cavity 9. In some embodiments, the anchor 17, which may be shaped, for example, into a hook-like configuration, may also be elastically released from the cavity 9 as the nose cone 8 is advanced, and assumes its hook shape to secure the most proximal end portion of the distal edge of the proximal implant segment 19 to the proximal wall of the deep artery 4. In some embodiments, the anchor 17 may be released when the outer sheath 12 is retracted proximally and when the nose cone 8 is advanced distally. In alternative embodiments, the anchor 17 is absent due to the sufficient anchoring provided by the juxtaposition between the struts of the implant 13 and the surrounding anatomical structures.

[0080] In the illustrated embodiment, the distal implant segment 18 provides a device for fixing the distalmost portion of the distal edge of the proximal implant segment 19 so that it does not invade the luminal space of the deep artery 4. The distal implant segment 18 can also provide radial support for the deep artery 4 to ensure the patency and sufficient distal blood flow after the implant 13 is implanted. The distal implant segment 18 can be sized to be accommodated by the deep artery 4. In some embodiments, the diameter of the distal implant segment 18 is greater than 0-50% of the deep artery 4. In other embodiments, the diameter of the distal implant segment 18 is greater than 5-25% of the deep artery 4. In some embodiments, the proximal implant segment 19 has a diameter between about 2mm and about 7mm. In some embodiments, the distal implant segment 18 has a diameter between about 2mm and about 7mm. In some embodiments, the proximal implant segment 19 and the distal implant segment 18 can have about the same diameter. In some embodiments, the proximal implant segment 19 and the distal implant segment 18 can have different diameters. In some embodiments, the proximal implant section 19 has a diameter of about 5mm, and the distal implant section 18 has a diameter of about 4mm. In some embodiments, the distal implant section 18 has a diameter of about 4mm, and the proximal implant section 19 is tapered so that the distal side of the proximal implant section 19 has a diameter of about 4mm and the proximal side of the proximal implant section 19 has a diameter of about 5mm. In some embodiments, the cross-sectional shape of the proximal implant section 19 and / or the distal implant section 18 may not be circular, and therefore they may alternatively have a cross-sectional area and / or periphery that may be the same or different. In some embodiments, there is no distal implant section 18 portion of the implant 13. In some embodiments, there is no distal implant section 18 portion of the implant 13, and the distal end of the proximal implant section 19 may include a continuous pillar and / or ring, which may also be referred to as anastomotic ring. In some embodiments, the distal implant segment 18 portion of the implant 13 is not present, and the distal side of the proximal implant segment 19 may include a continuous strut and / or ring having a skirt and / or flange that extends into the deep artery 4 and seals against the near wall of the deep artery 4 when deployed.

[0081] Fig. 9 An initial step of removing the delivery system 29 is depicted, according to some embodiments, wherein the outer sheath 12 and intermediate shaft 16 are advanced distally through the delivered (e.g., expanded) implant 13 and into the cavity 9. In some embodiments, during the advancement step, the intermediate shaft 16 guides the outer sheath 12 to facilitate secure engagement of the outer sheath 12 into the cavity 9 without the outer sheath 12 catching on the proximal end 11 of the distal nose cone 8.

[0082] Fig. 10AA continuation of the removal of the delivery system 29 is depicted, wherein the delivery system 29 is rotated, e.g., approximately 180 degrees, about its axis so that the proximal end portion of the tapered proximal end 11 of the nose cone 8 is on the inside of the curvature 6. In this orientation, the gap 14 is minimized, eliminated, or substantially eliminated, and there is a flush contact between the proximal tapered end 11 and the outer sheath 12. This low-profile configuration facilitates removal of the nose cone 8 without engaging the delivered implant 13 or any anatomical features near the AVF location 7.

[0083] Fig. 10B An alternative embodiment for providing a low-profile removal configuration for the delivery system 29 is depicted. In this embodiment, the nose cone 8 is rotated about its axis, for example, about 180 degrees, before the outer sheath 12 is advanced through the implant 13. After the nose cone 8 is rotated, the outer sheath 12 is advanced through the implant 13 until it engages the proximal end of the tapered proximal end 11. Due to the tapered structure of the tapered proximal end 11, as the outer sheath 12 advances, it can enter the inner diameter of the outer sheath 12. In this configuration, there are no structures on the delivery system 29 that can interfere with its removal from the body. In this embodiment, to complete the removal, the delivery system is retracted while keeping the outer sheath 12 overlapped on the nose cone 8 until it leaves the body.

[0084] Fig.11 Depicted in Fig. 10A . The tapered proximal end has entered the delivered (e.g., expanded) distal implant section 18 without interference due to the low profile configuration. A preferred embodiment is that the implant 13 has an unconstrained delivered (e.g., expanded) internal dimension that is larger than the external dimension of the nose cone 8, so that when removed through the implant 13, the nose cone 8 does not experience excessive resistance or interference with the implant 13.

[0085] Fig.12 Depicted is further continuation of the removal of the delivery system 29. The delivery system 29 has been further retracted and the nose cone 8 has advanced partway through the proximal implant section 19 of the implant 13.

[0086] Fig.13 The continuation of the removal of the delivery system 29 is depicted. The delivery system 29 has been fully retracted through the implant 13. Due to the curvature of the anatomy at this location, the gap 14 may form again. If the gap 14 causes undue resistance to the continued removal of the delivery system 29 from the body, the delivery system 29 may be rotated again to minimize and / or eliminate the gap 14 and allow minimal resistance to the removal of the delivery system 29.

[0087] Fig.14The beginning of the removal of the guidewire 5 from the body is depicted. Before removing the guidewire 5, it may be desirable or advantageous to advance a balloon dilatation catheter of a size appropriate for the implant 13 and the vasculature to facilitate full expansion of the implant 13. In some embodiments of the proximal implant segment 19 and the distal implant segment 18 having different diameters, cross-sectional areas, and / or circumferences, balloon dilatation catheters of different sizes may be used to facilitate full expansion of the proximal implant segment 19 and the distal implant segment 18. For example, in some embodiments, a 4 mm×20 mm or 2 mm×30 mm semi-compliant rapid exchange percutaneous transluminal angioplasty balloon may be used. The balloon dilatation catheter may be used to facilitate full expansion of the implant 13, for example, when blood flow is insufficient to maintain full expansion of the implant 13 (e.g., less than about 200 ml / minute). One cause of insufficient blood flow is vasospasm outside the implant 13. When used, the balloon expansion catheter can be extended throughout the implant 13 (both the distal implant section 18 and the proximal implant section 19) and also target adjacent veins and arteries.

[0088] Fig.15 Describe the complete delivery of implant 13, wherein, distal implant section 18 is in deep artery 4 and proximal end section 19 forms AVF between deep vein 3 and deep artery 4.In this embodiment, implant 13 is anchored in place at least partially by anchor 17 (as shown, it faces proximal direction) and distal implant section 18.Alternative anchoring features such as barbs can also be used with some embodiments.The anchor and / or barbs of implant 13 can extend in proximal direction, distal direction, bidirectional (for example, both proximal and distal) and / or angled relative to proximal and distal directions.Although implant 13 is shown as having proximal implant section 19, this proximal implant section has anchor and / or barbs, in some embodiments, distal implant section 18 can include anchor and / or barbs as described herein. In some embodiments, one or both of the proximal implant segment 19 and the distal implant segment 18 can include one or more anchors configured to anchor one or both segments against a vein wall, an arterial wall, and / or interstitial tissue.

[0089] In a preferred embodiment, the implant 13 is covered with a biocompatible graft material (such as, for example, ePTFE, etc.) The biocompatible graft material can promote endovascular healing while minimizing the luminal stenosis caused by hyperplasia. In some embodiments, the graft material encapsulation can be constructed using an inner layer of a porous graft material (such as ePTFE, etc.) covering the inner surface of the implant 13 and an outer layer of a porous graft material (such as ePTFE, etc.) covering the outer surface of the implant 13 that has been combined together. In some embodiments, the combination of the inner layer and the outer layer of the porous graft material encapsulates the pillars of the implant 13, and can be achieved by fusing the outer layer and the inner layer together with heat and compression. In these or other embodiments, a laminated layer of a thermoplastic material (such as a fluorinated ethylene propylene (FEP) film, polyethylene (PE) or a thermoplastic polyurethane film (TPU), etc.) can be placed between the inner layer and the outer layer of the porous graft material to promote bonding. In some embodiments, the thermoplastic laminated layer can be porous, and in other embodiments, the laminated layer can be non-porous. In some embodiments, the porosity of the encapsulated implant 13 can be maintained by spirally winding a strip of a non-porous thermoplastic laminate layer between the inner and outer layers of the porous graft material and leaving a gap between each winding of the thermoplastic laminate layer. In some embodiments, no gap is left between each winding of the thermoplastic laminate layer, leaving the final assembly to be non-porous, but with a porous surface. Covering or encapsulating the proximal implant segment 19 with a graft material can prevent blood from penetrating into any interstitial tissue between the deep vein 3 and the deep artery 4 that may cause hematoma, infection and other complications. Covering the proximal implant segment 19 with a graft material can also help deliver blood flow from the deep artery 4 to the superficial vein 1.

[0090] Fig.16A , Fig. 16B and Fig. 16C An embodiment of an implant 13 is depicted. Fig.16A A pattern is shown that is intended to be cut from a superelastic tubing (such as a superelastic NiTi tubing, etc.) to form features of the implant 13 (e.g., the implant 13 can be formed from a single laser cut hypotube). Segments of the cutting pattern are shown that form the proximal implant segment 19, the distal implant segment 18, the anchor 17, and the connector strut 20. In some embodiments, the implant 13 may alternatively be made of superelastic wire or formed from roll cut superelastic sheet stock. Fig. 16B Describes from Fig.16A The pattern is cut out of the tube after the shape of the implant 13. Fig. 16CDepicted is an implant 13 having a distal implant segment 18, a proximal implant segment 19 and a connector strut 20 after it has been shaped using well-known techniques by a superelastic tube such as a superelastic NiTi tube. As shown, the proximal implant segment 19 and / or the distal implant segment 18 may include a plurality of struts 20.

[0091] Fig. 16C Also depicted in the figure is a graft material 38 covering the inner diameter of the proximal end segment 19. The graft material 38 can be used to cover the inner diameter or outer diameter or both of the inner diameter and outer diameter of any portion (e.g., its entirety or less than its entirety) of the implant 13, depending on the specific needs of the application. Expanded polytetrafluoroethylene (also referred to as ePTFE) has been shown to be a favorable graft covering for intravascular implants. Other materials such as polyester mesh may also be suitable for certain embodiments. The implant 13 can be covered or encapsulated with a biocompatible graft material as described elsewhere herein.

[0092] In certain embodiments, proximal implant section 19 can comprise elongated tubular member or body, and this elongated tubular member or body have proximal end, distal end, extend through axis therein and pass flow path / lumen therein.In certain embodiments, distal implant section 18 can comprise elongated tubular member or body with proximal end, distal end, extend through axis therein and pass flow path / inner chamber therein.Proximal implant section 19 and / or distal implant section 18 can be linear straight when unconstrained (for example, expansion) or when being shaped as shown in the figure or being in static configuration.In addition, as shown in the figure, proximal implant section 19 can have axial length larger than the axial length of distal implant section 18.In certain embodiments, distal implant section 18 can be positioned at the downstream (for example, about the downstream of arterial blood flow direction) of the position of the distal end of proximal implant section 19. In some embodiments, the implant 13 may not have a proximal end segment, a distal segment, and / or anchoring features, and may have a more basic structure requiring only precise placement within the body.

[0093] In some embodiments, the anchoring features of the implant 13 (such as anchors 17, etc.) can form an angle of about 10 degrees to about 90 degrees relative to the body of the implant 13 in the proximal direction and / or the distal direction. In some embodiments, the anchoring features of the implant 13 (such as anchors 17, etc.) can form an angle of about 35 degrees to about 40 degrees relative to the body of the implant 13 in the proximal direction and / or the distal direction. The implant 13 can also be made of a bioresorbable material (such as PLA, PGA, PLLA, etc.) or other suitable materials for a specific application. The implant 13 can also be coated with heparin and / or therapeutic agents on its inner surface, outer / outer surface, or both the inner and outer / outer surfaces, including well-known drugs and compounds that reduce intimal hyperplasia and / or vascular stenosis in intravascular implant applications. In some embodiments, according to Figure 16A-16C The implant 13 may be only partially covered or encapsulated with a biocompatible graft material (including a laminate layer and / or a coating), for example, only the proximal implant section 19 may be covered / encapsulated with a biocompatible graft material (with a laminate layer) and coated.

[0094] In some embodiments, Fig.16D As shown, during the manufacturing process, an implant framework 41 (e.g., the struts described herein) can be placed on an inner layer 43 of a porous graft material (such as ePTFE, etc.). The inner layer 43 can extend the length of a portion of the implant 13 (e.g., the proximal implant segment 19) or the entire length of the implant 13. Fig.16DA spiral winding of a strip 45 of a non-porous thermoplastic laminate layer (e.g., FEP), which is schematically shown in FIG, can be applied around the implant frame 41 so that no gaps are left on one side of the implant frame 41 (e.g., a more distal segment), but a gap 49 is left between each winding or turn of the strip 45 on the other side of the implant frame 41 (e.g., a more proximal segment) to improve bending flexibility. Flexibility can be improved because the area of ​​the wound strip 45 including the thermoplastic laminate is stiffer. Accordingly, areas where no thermoplastic laminate is wound (such as the exposed portion 41a of the implant frame 41 (i.e., areas where there are gaps 49 in the spiral winding of the strip 45 of the thermoplastic laminate layer)) can be more flexible. In some embodiments, the proximal implant segment 19 may include gaps 49 between one or more turns of the strip 45 (e.g., between three adjacent turns). The strip 45 can be applied to some or all of the struts in adjacent rows of struts in the proximal implant segment 19. In some embodiments, gaps 49 are formed in the proximal end portion of the proximal implant segment 19, where additional flexibility may be desired, but are not formed along the distal portion of the proximal implant segment 19, where a non-porous portion is desired to prevent blood penetration. In some embodiments, gaps 49 between turns of the strip 45 can be aligned with gaps between adjacent rows of struts of the implant frame 41. Exposed portions 41a of the implant frame 41 corresponding to gaps 49 are not covered by the strip 45 and can have greater flexibility. The flexibility of the proximal implant segment 19 can be increased, for example, to provide the ability to bend, such as Fig.18D and Fig.19B , etc. A second or outer layer of a porous graft material (not shown), such as ePTFE, etc., may be applied over the wrapped strips 45 of the laminate, including over the exposed portion 41a of the implant frame 41. Pressure and heat may be used to melt the laminate and fuse the inner layer 43 and the outer layer, wherein the implant frame 41 is embedded between the inner layer 43 and the outer layer.

[0095] Figures 17A-17I An embodiment of an implant 13 is depicted. Fig.17ADescribe the pattern of the feature (for example, implant 13 can be formed by a single laser cutting hypotube) intended to be cut from a superelastic pipe (such as a superelastic NiTi pipe, etc.) to form an implant 13. Shown are sections of a cutting pattern forming a proximal implant segment 19, a distal implant segment 18, and a connector strut 20 that connects the proximal implant segment 19 to the distal implant segment 18. In some embodiments, the implant 13 includes an anchor 17 as additionally shown in a cutting pattern. In some embodiments, the proximal implant segment 19 may include an elongated tubular member or body having a proximal end, a distal end, an axis extending therethrough, and a flow path / lumen therethrough. In some embodiments, the distal implant segment 18 may include an elongated tubular member or body having a proximal end, a distal end, an axis extending therethrough, and a flow path / lumen therethrough. In some embodiments, the distal implant segment 18 can be positioned downstream (eg, downstream with respect to the direction of arterial blood flow) from a location distal to the proximal implant segment 19 .

[0096] In some embodiments, the implant 13 includes a continuous strut / ring 21 (also referred to as an anastomotic ring) at the distal edge of the proximal implant segment 19, as further shown in the cut pattern (e.g., at the distal edge of the distal side of the proximal implant segment 19). Fig.17A As shown, the continuous strut / ring 21 may include strut elements 21A, 21B, 21C, 21D, 21E, 21F, 21A', wherein the strut elements 21A, 21A' are continuous with each other (ie, in Fig.17A They are shown as spaced apart because it is a cutting pattern; when cut into a tube, the strut elements 21A, 21A' are continuous with each other). In some embodiments, the continuous strut / ring 21 can provide a continuous distal edge to the proximal implant segment 19 to reduce wrinkles in the encapsulated graft material. In some embodiments, the continuous strut / ring 21 can provide a continuous distal edge to the proximal implant segment 19 to improve the sealing of the implant 13 at the inner wall of the deep artery 4. In some embodiments, the continuous strut / ring 21 can increase the radial stiffness of the distal edge of the proximal implant segment 19 to help maintain the fistula diameter and / or cross-sectional area (e.g., the increased radial stiffness can result in increased radial expansion of the fistula).

[0097] In some embodiments, the proximal implant segment 19 may include struts of different lengths, and additionally illustrates segments of a cutting pattern that forms struts 36 of shorter lengths and struts 37 of longer lengths. In some embodiments, in addition to being longer, struts 37 may have a greater thickness / width than struts 36. In some embodiments, the location of longer and / or thicker / wider struts 37 may allow a larger diameter and / or cross-sectional area of ​​the implant 13 to be formed relative to the diameter and / or cross-sectional area of ​​the struts 36 of the implant 13. In some embodiments, the location of longer and / or thicker / wider struts 37 may allow the radial stiffness of the implant 13 to be increased relative to the radial stiffness of the implant 13 where struts 16 are located. In some cases, thinner struts may be used to reduce the radial stiffness at the location where the implant is located. Sometimes, longer struts may reduce the radial stiffness at the location where the implant is located. In some embodiments, the distal end and / or proximal end of the proximal implant segment and / or the distal implant segment may include a reduced radial stiffness compared to the radial stiffness along its axial length (e.g., to reduce mechanical stress concentration at the vessel / implant interface).

[0098] In some embodiments, implant 13 may alternatively be made from superelastic wire or formed from roll cut superelastic sheet stock. Fig. 17B depicts a stereoscopic view of an implant 13, Fig. 17C Depicted is a side view, Fig.17D A top view is depicted, and Fig.17E Depicted is a bottom view of implant 13 wherein distal implant segment 18, proximal implant segment 19, connector strut 20, anchor(s) 17, continuous strut / ring 21, shorter strut 36, and longer strut 37 have been removed from the implant. Fig.17A The pattern and shape are set after cutting in a superelastic tube (such as NiTi tube, etc.). Fig.17F Depicted is a front (distal end) view, Figure 17G Depicted is a posterior (proximal end) view, Fig.17H 171 depicts a front (distal end) view through the longitudinal axis of the distal implant segment 18, and FIG. 172 depicts a rear (proximal end) view through the longitudinal axis of the proximal implant segment 19 of the implant 13, wherein, Figure 17A-17E Some of the different features identified in Fig.17A The pattern and shape setting is shown after cutting with a superelastic pipe (such as NiTi pipe, etc.). Figures 17A-17I Not shown, but Figures 17A-17I The implant 13 may include any one or more of the features described with respect to the implant 13 described herein, including Figure 8 , Fig.15 as well as Figure 16A-16CAn implant of the invention is provided, such as covered or encapsulated with a biocompatible graft material (with a laminate layer) and coated with heparin and / or other therapeutic agents. Figures 17A-17I The implant 13 may be only partially covered or encapsulated with a biocompatible implant material (including a laminate layer and / or a coating), for example only the proximal implant section 19 may be covered / encapsulated with a biocompatible implant material (with a laminate layer) and coated.

[0099] Figures 18A-18C Various embodiments of the implant 13 are depicted after being shaped and encapsulated with a biocompatible graft material as described herein. Fig.18A The implant 13 can be used with Figures 17A-17I , and is shown to include a distal implant segment 18, a proximal implant segment 19, a connector strut 20, an anchor 17, a continuous strut / ring 21, a shorter strut 36, and a longer strut 37. As shown, and in accordance with some embodiments, a segment of the proximal implant segment 19 that positions the longer struts 37 has been formed to have a larger diameter than a diameter of the proximal implant segment 19 that positions the shorter struts 36. In other words, in some embodiments, the proximal implant segment 19 can be tapered such that the distal end of the proximal implant segment 19 has a different (e.g., smaller) diameter than the proximal end of the proximal implant segment 19. In alternative embodiments, for example Fig.18B As shown, the proximal implant section 19 of the implant 13 can include struts having substantially similar lengths and have a substantially uniform diameter. Fig.18B Also shown are various features of the implant 13 as described herein, including the distal implant segment 18, the aforementioned proximal implant segment 19, the connector struts 20, the anchors 17, and the continuous struts / rings 21. Alternative embodiments of the implant 13, such as in Fig.18C As shown in FIG. 1 , the implant may include a distal implant segment 18 , a proximal implant segment 19 , a connector strut 20 , an anchor 17 , a continuous strut / ring 21 , a shorter strut 36 , and a longer strut 37 . Fig.18C Also shown is a proximal implant segment 19, which can be tapered such that a distal end of the proximal implant segment 19 has a different (eg, smaller) diameter than a proximal end of the proximal implant segment 19. In addition, Fig.18C The proximal implant segment 19 shown in FIG. Fig.18A and Fig.18B Those shown in FIG. 5 are shorter, having four (as opposed to six) struts 36 , 37 . Figures 18A-18C The illustrated embodiment emphasizes that the proximal implant segment 19 is understood not to be limited to the length shown in the single figure. 18A to 18CAs shown, the proximal implant section 19 and / or the distal implant section 18 of implant 13 can be linearly straight when unconstrained or as a shape setting or in a static configuration. In addition, as shown in the figure, the proximal implant section 19 can have an axial length greater than the distal implant section 18. Additionally and as shown in the figure, when the proximal and distal implant sections were fully expanded in a static configuration, the proximal implant section 19 can be oriented at an angle relative to the distal implant section 18.

[0100] Fig.18D Describes the basis Figures 17A-17I , Figures 18A-18CAnd the implant 13 in the unbent state and the bent state superimposed on each other as described herein.The unbent state and the bent state of implant 13 can correspond to the state of implant 13 after being implanted in the patient as described herein, such as when the patient's arm is roughly straight around the elbow (corresponding to the unbent state) and when the patient's arm is roughly bent at the elbow (corresponding to the bent state) etc.As shown in the figure, the proximal implant section 19 is configured to bend or bend relative to the distal implant section on the direction away from the side opening 60.As shown in the figure, the proximal implant section 19 can bend or bend at least about 90 degrees relative to the distal implant section 18 on the direction away from the side opening 60. In some embodiments, the proximal implant segment 19 is capable of bending or flexing at least about 35 degrees, at least about 40 degrees, at least about 45 degrees, at least about 50 degrees, at least about 55 degrees, at least about 60 degrees, at least about 65 degrees, at least about 70 degrees, at least about 75 degrees, at least about 80 degrees, at least about 85 degrees, at least about 90 degrees, at least about 95 degrees, at least about 100 degrees, at least about 105 degrees, at least about 110 degrees, at least about 115 degrees, at least about 120 degrees, at least about 125 degrees, at least about 130 degrees, at least about 135 degrees, at least about 140 degrees, at least about 145 degrees, at least about 150 degrees, at least about 155 degrees, at least about 160 degrees, at least about 165 degrees, at least about 170 degrees, at least about 175 degrees, at least about 180 degrees or more or any angle relative to the distal implant segment 18 in a direction away from the side opening 60. The proximal implant section 19 can be bent or folded relative to the distal implant section 18, and basically keep patent / open, so as to allow flow through it when bent or folded (for example, the blood flow through the proximal implant section 19 is not reduced when bent). In addition, the proximal implant section 19 can be bent or folded relative to the distal implant section 18 without kinking or elliptical (for example, becoming elliptical in cross section). In other words, the proximal implant section 19 can be bent or folded relative to the distal implant section 18, and keep it basically similar or identical to its unbent state in cross-sectional area. This configuration of the proximal implant section 19 can advantageously minimize and / or eliminate the force of the implant 13 on the blood vessel implanted by the blood vessel when the blood vessel undergoes bending and / or shape change through the patient's movement (for example, the movement of the patient's arm around its elbow). The proximal implant segment 19 can be bent or flexed relative to the distal implant segment 18, and the radius of curvature R of the bend / bend is about 6mm, about 5.5mm, about 5.0mm, about 4.5mm, about 4.0mm, about 3.5mm, about 3.0mm, about 2.9mm, about 2.8mm, about 2.7mm, about 2.6mm, about 2.5mm, about 2.4mm, about 2.3mm, about 2.2mm, about 2.1mm, about 2.0mm, less than about 2.0mm or greater than about 6mm or any range therebetween.

[0101] Fig.19A Another embodiment of an implant 13 is depicted, particularly a pattern intended to be cut from a superelastic tubing (such as a superelastic NiTi tubing, etc.) to form features of the implant 13 (e.g., the implant 13 may be formed from a single laser cut hypotube). Fig.19A The implant 13 can be the same or similar to any one or more of the features described and / or illustrated with respect to the implant 13 as described herein and / or can combine any one or more of these features. For example, Fig.19A The implant 13 shown in the figure may include a proximal implant segment 19 including a plurality of struts having a continuous strut / ring 21 (e.g., anastomotic ring) at its distal end, a distal implant segment 18, a side opening 60, and one or more anchors 17 facing in the proximal and / or distal directions, the proximal implant segment 19 including a plurality of struts connected to the proximal implant 19 by connecting struts 20. The implant 13 can be configured so that the proximal implant segment 19 has a different flexibility than the distal implant segment 18. For example and as will be discussed, the proximal implant segment 19 can be configured to have greater flexibility than the distal implant segment 18. The increased flexibility of the implant 13 (particularly the proximal implant segment 19) can advantageously minimize stress on the blood vessel in which the implant 13 is implanted, and allow the blood vessel to move normally without the implant 13. Stress on the blood vessel can promote intimal hyperplasia and suboptimal healing, so an implant 13 with increased flexibility can help avoid such conditions and promote healing.

[0102] The proximal implant segment 19 may include a series of rows of struts arranged substantially circumferentially around the axis of the proximal implant segment 19, and in some embodiments, the series of rows of struts may include wavy struts as shown. The series of rows of struts of the proximal implant segment 19 may be connected to each other by one or more axially extending struts 61 arranged substantially along the axis of the proximal implant segment 19. Similarly, the distal implant segment 18 may include a series of rows of struts arranged substantially circumferentially around the axis of the distal implant segment 18, and in some embodiments, the series of rows of struts may include wavy struts as shown. The series of rows of struts of the distal implant segment 18 may be connected to each other by one or more axially extending struts 61 arranged substantially along the axis of the distal implant segment 18. In order to achieve the above-mentioned greater flexibility of the proximal implant segment 19 relative to the distal implant segment 18, in some embodiments, the series of rows of struts of the distal implant segment 18 may be connected to each other by at least one strut 61 that extends more axially than the series of rows of struts of the proximal implant segment 19. For example and as shown, adjacent rows of struts of the proximal implant segment 19 may be connected by no more than one axially extending strut 61 , while adjacent rows of struts of the distal implant segment 18 may be connected by two (e.g., at least more) axially extending struts 61 .

[0103] In addition to or in lieu of the number of axially extending struts that have an effect on the relative flexibility of the proximal implant segment 19, the location of such axially extending struts of the proximal implant segment 19 can affect the flexibility of the proximal implant segment 19 (and similarly the flexibility of the distal implant segment 18). Fig.19A As shown, most or all of one or more axially extending struts 61 of the proximal implant segment 19 can be located on a side of the proximal implant segment 19 that is aligned with the position of the side opening 60 (which corresponds to the middle portion of the implant 13 extending from left to right in the cutting pattern shown). The side aligned with the side opening 60 can be up to and including about 90 degrees circumferentially on each side of the circumferential center of the side opening. Fig.19A As shown, on each side of the circumferential center of the side opening, the side aligned with the side opening 60 up to and including about 90 degrees can include about 180 degrees between the connector struts 20. By avoiding having axially extending struts 61 on the side of the implant 13 opposite the side opening 60, when the proximal implant segment 19 is bent or flexed, the struts of adjacent rows of the proximal implant segment can be brought closer to each other without the axially extending struts 61 that prevent such movement. In addition, when the proximal implant segment 19 is bent or flexed, any graft material 38 in the proximal implant segment 19 in such an area opposite the side opening can fold and / or wrinkle.

[0104] In some embodiments, the pillars of adjacent rows arranged substantially circumferentially around the axis of the proximal implant section 19 and / or the distal implant section 18 can be connected separately by the graft material / covering 38 without any axially extending pillars 61. In such embodiments, the implant framework can generally include an assembly of multiple rows of pillars held together by the graft material / covering 38, rather than laser cutting from a tube. Such embodiments can provide proximal implant sections 19 and / or distal implant sections 18 with increased flexibility. In some cases, and for any of the implants 13 described herein, the pillars arranged substantially circumferentially around the axis of the proximal implant section 19 and / or the distal implant section 18 can be formed as rings rather than corrugated pillars, and / or can include a mixture of rings and corrugated pillars.

[0105] Fig.19B Describes the Fig.19AAnd the implant 13 in the unbent state and the bent state superimposed on each other as described herein. The unbent state and the bent state of the implant 13 may correspond to the state of the implant 13 after being implanted in the patient as described herein, such as when the patient's arm is roughly straight around the elbow (corresponding to the unbent state) and when the patient's arm is roughly bent at the elbow (corresponding to the bent state) etc. As shown, the proximal implant section 19 is configured to bend or bend relative to the distal implant section in the direction away from the side opening 60. As shown, the proximal implant section 19 can be bent or bend at least about 180 degrees relative to the distal implant section 18 in the direction away from the side opening 60. In some embodiments, the proximal implant segment 19 can bend or bend relative to the distal implant segment 18 in a direction away from the side opening 60 by at least about 35 degrees, at least about 40 degrees, at least about 45 degrees, at least about 50 degrees, at least about 55 degrees, at least about 60 degrees, at least about 65 degrees, at least about 70 degrees, at least about 75 degrees, at least about 80 degrees, at least about 85 degrees, at least about 90 degrees, at least about 95 degrees, at least about 100 degrees, at least about 105 degrees, at least about 110 degrees, at least about 115 degrees. The proximal implant section 19 can be bent or folded relative to the distal implant section 18, and basically keep unobstructed / open, so that when bending or folding, allow the flow through it (for example, when bending, the blood flow through the proximal implant section 19 does not reduce). In addition, proximal implant section 19 can be bent or folded relative to distal implant section 18, without kink or elliptical (for example, becoming elliptical in cross section). In other words, proximal implant section 19 can be bent or folded relative to distal implant section 18, and remain substantially similar or identical to its unbent state in cross-sectional area. When blood vessel experiences bending and / or shape change by patient's motion (for example, patient's arm around the motion of its elbow), this configuration of proximal implant section 19 can advantageously minimize and / or eliminate the power of implant 13 to implanted blood vessel.The proximal implant segment 19 can be bent or flexed relative to the distal implant segment 18, and the radius of curvature R of the bend / bend is about 6mm, about 5.5mm, about 5.0mm, about 4.5mm, about 4.0mm, about 3.5mm, about 3.0mm, about 2.9mm, about 2.8mm, about 2.7mm, about 2.6mm, about 2.5mm, about 2.4mm, about 2.3mm, about 2.2mm, about 2.1mm, about 2.0mm, less than about 2.0mm or greater than about 6mm or any range therebetween. Fig.19A The configuration (eg, number and position) of the proximal implant segment 19 of the implant 13 via the axially extending struts 61 is relative to Fig.18A The proximal implant section 19 of the illustrated implant 13 may have increased flexibility.

[0106] Figure 20A-20B Additional embodiments of implants 13 are depicted, particularly implants cut from superelastic tubing (such as superelastic NiTi tubing or the like), and shaped into a form as described herein. Fig. 20A A side view of the implant 13 is shown, Fig. 20B A stereoscopic view of the implant 13 is shown. Figure 20A-20B The implant 13 may be the same or similar to any one or more of the features described and / or illustrated with respect to the implant 13 as described herein and / or may combine any one or more of these features. For example, Figure 20A-20B The implant 13 shown may include a proximal implant segment 19 including a plurality of struts having a continuous strut / ring 21 (e.g., an anastomotic ring) at its distal end, a distal implant segment 18 including a plurality of struts connected to the proximal implant 19 by connecting struts 20, a side opening 60 between the proximal implant segment and the distal implant segment, and one or more anchors 17. Unlike other embodiments described herein, according to Figure 20A-20B The distal implant section 18 of the implant 13 can be configured as an at least partially tubular body extending between its proximal end to its distal end. In such a configuration, the distal implant section 18 can provide at least partial radial support to the arterial wall opposite the distal end of the proximal implant section, such as Fig. 20C As shown, the implant 13 is implanted in the vascular system of the patient. Figure 20A-20BThe distal implant segment 18 is shown as having a partial tubular body that extends circumferentially approximately 180 degrees from one connecting strut 20 to the other connecting strut 20, but other configurations of the distal implant segment 18 may include a partial tubular body that extends circumferentially less than approximately 180 degrees (in which case the connecting struts 20 may be configured differently) or that extends circumferentially greater than approximately 180 degrees. For example, the distal implant section 18 can be configured as part of tubular body, and this part of tubular body extends circumferentially about 30 °, about 45 °, about 60 °, about 75 °, about 90 °, about 105 °, about 120 °, about 135 °, about 150 °, about 165 °, about 180 °, about 195 °, about 205 °, about 220 °, about 235 °, about 250 °, about 275 °, about 290 °, about 305 °, about 320 °, about 335 ° or higher than those angles listed, between those angles listed or greater than about any angle of those angles listed.As shown in the figure, in one example, the part of tubular body that forms the distal implant section can be oriented or aimed at a side identical with side opening 60 of implant.

[0107] Fig.21 A partial cross-sectional view of various elements of one embodiment of a delivery system 29 is depicted. A nose cone 8 having a distal taper 10 and a tapered proximal end 11 is shown connected to a guidewire shaft 22. The guidewire shaft 22 has an internal lumen that accommodates a guidewire 5 (shown elsewhere). An intermediate shaft 16 is slidably disposed on the guidewire shaft 22 and slidably disposed within the outer sheath 12, and adjacent to the proximal end of the constrained (e.g., collapsed) implant 13. The proximal end of the intermediate shaft 16 terminates at a location where it can be fixed to a proximal handle 23 or allowed to move relative to the handle 23. During delivery of the implant 13, the intermediate shaft 16 prevents the implant 13 from moving relative to the guidewire shaft 22 during retraction of the outer sheath 12. The implant 13 is elastically constrained (e.g., collapsed) within the outer sheath 12. The outer shaft 12 is attached to a control knob 26 which is slidably attached to the handle 23 so that controlled retraction of the outer sheath 12 can be achieved by sliding the control knob 26 proximally. The distal end of the outer sheath 12 terminates within the cavity 9 of the nose cone 8. At its proximal end, the guidewire shaft 22 is fixed to the handle 23 and the lumen is connected to the tube 25 which provides a conduit for the guidewire 5 to fully advance through the delivery system 29. A hemostatic valve can be fitted to the proximal end of the tube 25 to prevent backflow when the delivery system 29 is inserted into the vasculature. Fig.21Also depicted is a proximal handle 24 that facilitates manipulation of a delivery system 29 and some constrained (e.g., collapsed) elements of the implant 13, including the distal implant segment 18, the proximal implant segment 19, and the connector struts 20. A handle nose cone 27 provides a guide path and support for the outer sheath 12 slidably disposed within the handle nose cone 27. Fig.21 Depicted is a preferred embodiment of a delivery system. An alternative preferred embodiment of a delivery system 29 may include a thumb wheel control and pull wire feature of the outer sheath 12 to allow active deflection of the nose cone 8 to create a gap 14, rather than relying on the curvature 6 of the guide wire 5, as shown in Figure 6. The construction material of the delivery system 29 can be any material well known for catheter construction, such as PEEK, HDPE, PeBax, nylon, PTFE, combinations thereof, and others. The diameter and length of the delivery system 29 should be suitable for a specific application. In one embodiment, the profile of the nose cone 8 is between 6Fr and 9Fr for an implant 13 between 3mm and 6mm in diameter. In one embodiment, the distance between the handle 23 and the nose cone 8 is between about 15cm and about 30cm. Various lengths and diameters of the delivery system 29 can be used in various embodiments of the present invention to meet the needs of a specific application.

[0108] Fig.22A A three-dimensional view and a cross-sectional view of nose cone 8 are depicted. Nose cone 8 may include a generally tubular body having a distal end, a proximal end, and a longitudinal axis extending therebetween. According to some embodiments, tapered proximal end 11 is shown as having a profile intended to engage tissue when gap 14 is created and not engage tissue or implant structures when gap 14 is eliminated. In some embodiments, tapered proximal end 11 may engage tissue without gap 14 (such as with respect to Fig. 22B). In some cases, the tapered proximal end 11 may engage tissue when it is oriented substantially outside the bend (e.g., such as curvature 6, etc.), and may not engage tissue when it is oriented substantially inside the bend in other respects. The nose cone 8 may include a proximal opening forming a cavity (e.g., a central lumen) 9 having a size sufficient to receive an outer sheath 12 (not shown). The nose cone 8 may also include an opening extending longitudinally from the distal end of the cavity 9 through the tapered distal end 10 to allow a guidewire (e.g., guidewire 5) to extend longitudinally through the nose cone 8. In some embodiments, the proximal end of the nose cone 8 may be inclined relative to the longitudinal axis of the nose cone 8. As shown, the proximal tip 63 of the nose cone 8 may be radially aligned with the inner diameter of the cavity 9. In addition, and as shown in the longitudinal cross-section at the bottom, the proximal end 11 of the nose cone 8 may have a surface extending distally and radially outwardly from the proximal tip 63 to the outer diameter of the nose cone, thereby producing a tapered proximal end 11. In order to improve the flexibility between the nose cone 8 and the outer sheath 12, a slit or slot may be included in the wall forming the cavity 9, preferably in the area of ​​the shorter wall segment forming the cavity 9 shown in the cross-sectional view of the nose cone 8. The nose cone 8 includes a tapered distal section 10 that facilitates sliding over the guide wire 5 (not shown) and passing through anatomical structures that have not yet expanded to a diameter equal to or greater than the outer diameter of the nose cone 8. The tapered section 10 may taper distally in some cases, as illustrated. The nose cone 8 may be constructed of well-known materials suitable for catheters, such as PEEK, HDPE, and polypropylene, among others. In some embodiments, the nose cone 8 may include an echogenic feature to aid in ultrasound visualization.

[0109] Fig. 22B Depicts a 3-D view and a cross-sectional view of an enlarged view of the tapered proximal end 11 of the nose cone 8 according to some embodiments. Fig. 22B The nose cone 8 can be the same as the nose cone 8 described herein (such as with respect to Fig.22A Any one or more features described and / or illustrated in the drawings and / or the like) are the same or similar and / or any one or more of these features are combined. Different from other embodiments described herein, according to Fig. 22B The tapered proximal end 11 of the nose cone 8 can be configured to engage tissue without forming a gap 14 (e.g., when the outer sheath 12 is disposed within the cavity 9, no gap between the inner diameter of the cavity 9 and the outer sheath 12 is required). To achieve this, the most proximal tip 63 of the nose cone 8 can be spaced radially outward from the inner diameter of the cavity 9, such as Fig. 22BIn other words, the proximal-most tip 63 can be spaced radially outward from the virtual protrusion of the inner diameter of the proximal cavity 9 to form a radial gap between the proximal-most tip 63 and the virtual protrusion of the inner diameter. This radial gap allows the proximal-most tip 63 to engage tissue such as the wall of a vein or an artery in which the nose cone is positioned. Thus, as shown in the longitudinal cross-section and its enlarged view, according to Fig. 22B The tapered proximal end 11 of the nose cone 8 includes a first surface 64 extending proximally and radially outwardly from the inner diameter of the proximal cavity to the proximal tip 63, and a second surface 65 extending distally and radially outwardly from the proximal tip 63 to the outer diameter of the nose cone. After the delivery system 29 is pulled proximally from its position, the first surface 64 can engage the proximal wall of the deep artery 4, such as Figure 5 As shown, there is no need to form the gap 14. Figure 5 shown.

[0110] Figure 23A-23B A 3-D view and a cross-sectional view of the handle 23 and its various elements are depicted. A handle nose cone 27 is shown attached to the distal end of the handle 23 by a through lumen that slidably accommodates the outer sheath 12 (not shown). A control knob 26 is slidably constrained within the handle 23 and is used to control the axial position of the outer sheath 12 (not shown). A tube 25 allows a guide wire 5 (not shown) to pass through the handle 23.

[0111] Figure 24A-24H Depicted is an additional embodiment of a delivery system or device 29. The delivery device can be configured for percutaneous access into the arm or into another location in the patient. Fig.24A shows a perspective view of a delivery device 29 according to some embodiments, Fig. 24B shows a perspective cross-sectional view, and Fig.24C An exploded perspective view of the delivery device is shown. In addition, Fig.24D A cross-sectional view of the distal side of the delivery device 29 is shown, Fig.24E A perspective view of a delivery device 29 is shown with a portion of the handle housing of the delivery device 29 removed from view. Figure 24A-24H The delivery device 29 described can be used with Figure 21-23B The delivery device 29 described shares common elements and may be similar to that of Figure 21-23B The delivery device 29 described herein is functional; therefore, common elements may share common reference numerals to indicate a general correspondence between the referenced elements.

[0112] like Figure 24A-24HAs shown, the delivery device 29 may include a handle 23, a control knob 26, a guidewire shaft 22, an intermediate shaft 16, an outer sheath 12, and a nose cone 8. The handle 23 may include a right housing 42 and a left housing 44, which may be fixed together by mechanical fasteners, adhesives, or molded so as to be snap-fit ​​or press-fit together. Fig.24A As shown, the handle 23 may include a proximal handle 24 at its proximal end, which may facilitate manipulation of the delivery device 29. Fig.24A As shown, the handle 23 may include a nose cone 27 having a through lumen at its distal end, which may provide a guide path and support for the outer sheath 12 slidably disposed within the handle 23 and the nose cone 27. Fig.24A As shown, control knob 26 is slidably constrained within the longitudinal opening of handle 23, with a portion of control knob 26 extending outside handle 23, as shown, for manipulation by a user. Nose cone 8 may be disposed at the distal end of delivery device 29 and include features as described herein.

[0113] Fig. 24B A three-dimensional cross-sectional view of Fig.24C The exploded perspective view shows a Fig.24AAdditional details of the delivery device 29 shown. As shown, the guidewire shaft 22 can traverse the longitudinal length of the handle 23. The guidewire shaft 22 can be fluidly connected to a guidewire shaft connector 55 at its proximal end, which is partially arranged in the handle 23 at the proximal end of the handle 23. The guidewire shaft connector 55 can be similar to the tube 25 described herein. The guidewire shaft connector 55 can extend proximally beyond the handle 23 and terminate at a guidewire shaft connector fitting 56, which can be coupled to a valve and / or a pipeline for controlling backflow when the delivery device 29 is inserted into the vascular system. The guidewire shaft connector 55, which is fluidly connected to the guidewire shaft 22, can form a common lumen with the guidewire shaft 22 to allow the guidewire 5 (e.g., through the guidewire shaft connector fitting 56) as described herein to be inserted into the proximal end of the guidewire shaft connector 55, travel through the guidewire shaft connector 55, and then travel through the guidewire shaft 22 as the guidewire 5 is displaced distally. It is also shown that a guidewire shaft housing connector 57 can be disposed distally of a guidewire shaft connector fitting 56 within the handle 23, the guidewire shaft housing connector 57 being configured to attach to and provide support (e.g., mechanical support) for the guidewire 22. It is also shown that the delivery device 29 can further include an intermediate shaft connector 50 disposed within the handle 23 and configured to connect to the proximal end of the intermediate shaft 16. The delivery device 29 can further include an intermediate shaft connector stop 52, which can be a feature (e.g., a molded feature) of the handle 23 as shown. It is also shown that the control knob 26 can include a distal stop 47 and a proximal stop 48, which can interact with features of the handle 23, which in some embodiments include a distal housing stop 53 and a proximal housing stop 54. In addition, the control knob 26 can include a spring element 46, which can also interact with features of the handle 23.

[0114] Next, we will refer to Fig.24D Cross-sectional view and Fig.24E , which shows the delivery device 29 with the left housing 44 of the delivery device 29 removed from view, discusses further connection of elements and operation of the delivery device 29 according to some embodiments. As shown, the guidewire shaft 22 can extend substantially longitudinally within the handle 23 and, as described above, can be connected to the guidewire shaft connector 55 at its proximal end. In addition, the guidewire can extend distally through the handle nose cone 27 and terminate distally at the connection with the nose cone 8. Therefore, the guidewire shaft 22 in combination with the guidewire connector 55 and the nose cone 8 can form a central lumen configured to slidably accommodate a guidewire 5, as described herein (e.g., the guidewire 5 can slide within the delivery device 29, and / or the delivery device can slide along the guidewire 5).

[0115] The intermediate shaft 16 as described herein can be arranged coaxially with and slidably arranged along the guidewire shaft 22, and as shown can have a proximal end connected to the intermediate shaft connector 50 arranged in the handle 23 and a distal end that can terminate outside the nose cone 8. Therefore, the intermediate shaft 16 and the intermediate shaft connector 50 can be slidably moved together distally / proximally along the guidewire shaft 22. The intermediate shaft connector 50 can have a proximal end configured to abut against the intermediate shaft connector stop 52 when in its most proximal position and a distal end configured to interact with the control knob 26. In some embodiments, the intermediate shaft connector 50 can include an intermediate shaft connector recess 51, which is configured to engage the control knob 26 when the control knob 26 slides to its most proximal position in the handle 23. For example, the intermediate shaft connector recess 51 can frictionally engage the control knob 26 when the control knob 26 slides proximally and is brought into the recess. As another example, the intermediate shaft connector recess 51 may include a protrusion that helps the intermediate shaft connector 50 remain on / engage the control knob 26 as the control knob 26 slides proximally and passes over the protrusion within the recess.

[0116] The outer sheath 12 as described herein can be arranged coaxially with the intermediate shaft 16 and can slide along the intermediate shaft 16, and as shown can have a proximal end connected to the control knob 26 and a distal end that can terminate in the nose cone 8, partially terminate in the nose cone 8, or terminate near the nose cone 8. Therefore, the outer sheath 12 and the control knob 26 can be slidably moved together distally / proximally along the intermediate shaft 16. The control knob 26 can include a spring element 46 as shown, which is configured to provide an upward force to the control knob 26 through interaction between the spring element 46 and an inner surface (e.g., a longitudinally oriented inner surface) of the handle 23. The control knob 26 can also include features that can interact with the handle 23 and maintain the control knob 26 in a distal and / or proximal desired position. For example, the control knob 26 may include a distal stop 47 and a proximal stop 48 (which may each be in the form of a stepped edge) disposed proximal to its distal end and its proximal end, respectively, and as shown proximal to where the control knob 26 protrudes through the longitudinal opening of the handle 23, and the handle 23 may include a distal housing stop 53 and a proximal housing stop 54 configured to interact with the distal stop 47 and the proximal stop 48, respectively. Further and as shown, the distal housing stop 53 and the proximal housing stop 54 may be disposed proximal to the distal end and the proximal end of the longitudinal opening of the handle 23, respectively, and each distal end housing stop may include a ramp-like surface facing the control knob 26 and a stepped edge facing away from the control knob 26. In such an embodiment, and further for this example, when the control knob 26 is slid distally to its fully distal position, the control knob 26 can be deflected downward (e.g., inwardly into the handle 23) as the handle contacts and travels along the ramped surface of the distal housing stop 53 until the stepped edge of the distal stop 47 passes the stepped edge of the distal housing stop 53, at which point the control knob 26 can be returned to its more upward position within the handle 23, and the interaction between the stepped edge of the distal stop 47 and the distal housing stop 53 keeps the control knob 26 locked in place. To unlock the control knob 26 from this distal position, the control knob 26 can be pushed inwardly toward the center of the handle 23 (opposite the upward force provided by the spring element 46) until the stepped edge of the distal stop 47 disengages the stepped edge of the distal housing stop 53 (e.g., they no longer overlap longitudinally), and then the control knob 26 can be slid proximally. The locking and unlocking of the control knob 26 in its most proximal position can be similarly performed using the corresponding proximal stop 48 and proximal housing stop 54.In some embodiments, when the control knob 26 is slid proximally into its proximal-most position, the control knob 26 can engage the intermediate shaft connector recess 51 of the intermediate shaft connector 50, so that the intermediate shaft connector 50 is locked to the control knob 26; then, subsequent movement / sliding of the control knob 26 can cause the intermediate shaft connector 50 and the intermediate shaft 16 connected thereto to move with the control knob 26 and the outer sheath 12. The intermediate shaft connector stop 52 described above can assist in the engagement of the intermediate shaft connector 50 with the control knob 26 by preventing proximal movement of the intermediate shaft connector 50 when the control knob 26 is moved proximally into the intermediate shaft connector recess 51. In some embodiments, the control knob 26 and the handle 23 can include other features that help lock the control knob 26 in a desired position. In some embodiments, the distal stop 47, the proximal stop 48, the distal housing stop 53, and the proximal housing stop 54 can include features different from those described above, but can function similarly.

[0117] As described in this article and also in Fig.24D As shown in , the distal end of the delivery device 29 may include a nose cone 8, which includes a distal taper 10, a cavity 9, and a tapered proximal end 11. The distal taper 10 can be symmetrical along the longitudinal length of the nose cone 8 and can include a longitudinal through hole; in some embodiments, the guide wire shaft 22 can be attached to the nose cone 8 at the longitudinal through hole. The longitudinal through hole may include a diameter and / or cross-sectional area that is smaller than the diameter and / or cross-sectional area of ​​the cavity 9. The cavity 9 may include a diameter and / or cross-sectional area that is larger than the outer diameter of the outer sheath 12. The nose cone 8 may include a proximal side that is angled relative to the longitudinal length of the nose cone 8. For example, and using Fig.24D For reference, the nose cone 8 may similarly include a proximal side that is angled at approximately 30 degrees relative to the longitudinal length of the nose cone 8, but other angles may also be used. In some embodiments, the nose cone 8 may include a proximal end that is angled between approximately 5 degrees and approximately 90 degrees relative to the longitudinal length of the nose cone 8. In some embodiments, the nose cone 8 may include a proximal end that is angled at approximately 5 degrees, approximately 10 degrees, approximately 15 degrees, approximately 20 degrees, approximately 25 degrees, approximately 30 degrees, approximately 35 degrees, approximately 40 degrees, approximately 45 degrees, approximately 50 degrees, approximately 55 degrees, approximately 60 degrees, approximately 65 degrees, approximately 70 degrees, approximately 75 degrees, approximately 80 degrees, approximately 85 degrees, or approximately 90 degrees relative to the longitudinal length of the nose cone 8. In some embodiments, the angled proximal end of the nose cone 8 may allow the nose cone 8 to deflect preferably in one direction and not in another direction. For example, Fig.24DThe nose cone 8 shown in the figure can preferentially deflect upward (i.e., the distal end of the nose cone 8 can deflect upward) and not preferentially deflect downward due to the angled proximal end. In some embodiments, the distal end of the nose cone 8 can be inhibited from moving in one direction due to the angled proximal end of the nose cone 8 substantially inhibiting movement (e.g., due to interaction with any of the guidewire shaft 22, the intermediate shaft 16 and / or the outer sheath 12, the proximal end of the nose cone inhibits movement). The proximal-facing edge of the proximal side of the nose cone 8 may include a tapered portion, such as Fig.22A As shown, it may also be referred to as the tapered proximal end 11 described herein. As shown, the tapered proximal end 11 of the nose cone 8 may taper downwardly in the proximal direction to a smaller cross-sectional area, that is, it may include a taper opposite to the distal taper 10. In this way, the taper of the tapered proximal end 11 may facilitate the retraction of the nose cone 8 as described herein. In some embodiments, the proximal end of the nose cone 8 may include a cross-sectional shape that is circular, round, oval, elliptical, pear-shaped, egg-shaped, or any symmetrical or irregular shape. In some embodiments, the width of the proximal end of the nose cone 8 may be greater than the height of the proximal end of the nose cone 8 along the longitudinal axis of the nose cone 8. In some embodiments, the cavity 9 may be sized to be larger than the outer diameter of the outer sheath 12. In some embodiments, the cavity 9 may have a width greater than its height.

[0118] The guidewire shaft 22 can provide a semi-rigid, semi-flexible conduit that can be used as a conduit extending from the handle 23 of the delivery device and terminating at the distal end of the nose cone 8. Therefore, in use, the distal or proximal position of the nose cone 8 in the body can be directly affected by the distal or proximal movement of the delivery device 29, such as by the influence of the clinician operating the delivery device 29, etc. As described herein, the distal and / or proximal movement of the intermediate shaft 16 and / or the outer sheath 12 can be controlled by manipulating the control knob 26 (e.g., by sliding the distal and / or proximal sides of the control knob 26). The delivery device 29 can be configured for single-handed operation by a clinician / user / operator. The single-handed operation of the delivery device 29 can advantageously allow the clinician / user / operator to keep their other hand free to perform additional aspects related to the surgery. In addition, the single-handed operation of the delivery device 29 can reduce and / or eliminate the need for additional staff to assist in the surgery. In addition, the single-handed operation of the delivery device 29 can advantageously increase the efficiency of the surgery. One-handed operation of the delivery device 29 may advantageously allow the clinician / user / operator to simultaneously control the ultrasound imaging probe with their other hand during a procedure.

[0119] Fig.24F The distal end of a delivery system 29 is depicted, according to some embodiments. Fig.24F2 shows variations of the outer sheath 12 and intermediate shaft 16 that can aid in the operation of the delivery device 29. As shown, the intermediate shaft 16 can have a tapered distal end to facilitate passage of the intermediate shaft 16 through the expanded implant 13 and / or into the cavity 9 of the nose cone 8. It is also shown that the outer sheath 12 can have a tapered distal end to facilitate passage of the outer sheath 12 through the expanded implant 13 and / or into the cavity 9 of the nose cone 8. In addition, the intermediate shaft 16 can have an interference fit with the guidewire shaft 22, and / or the outer sheath 12 can have an interference fit with the intermediate shaft 16.

[0120] Figure 24G and Fig.24H A delivery system 29 is depicted carrying an implant in its radially compressed configuration according to some embodiments. Figure 24G Also depicted is a safety clip 39 removably disposed proximal to the control knob 26. During transport and until use, the safety clip 39 can prevent the control knob 26 from inadvertently sliding proximally. Prior to use, the safety clip 39 can be removed, which can allow the control knob 26 to be moved proximally, as may be required to deliver the implant 13 into the patient's body. In some embodiments and as described herein and as Fig.24H As shown, at least a portion of the implant 13 may be disposed within the nose cone 8 and at least a portion of the implant 13 may be disposed within the outer sheath 12 . Fig.24H Also depicted is a guidewire shaft 22 extending distally beyond the distal tip of the nose cone 8. Although the guidewire shaft 22 may extend distally beyond the distal tip of the nose cone 8, it should be understood that this is not a necessary feature of the illustrated embodiment.

[0121] The delivery device 29 can be used for percutaneous delivery of an intraluminal implant 13, as described herein. In some embodiments and as described herein, at least a portion of the implant 13 can be arranged in the cavity 9 of the nose cone 8. In some embodiments, at least a portion of the implant 13 can be arranged in the outer sheath 12. In some embodiments, when the implant is arranged in the delivery device 29, the intermediate shaft 16 can be adjacent to the end (e.g., the proximal end) of the implant 13. In some embodiments, the implant 13 can be slidably arranged on the guidewire shaft 22. In some embodiments, the implant can be at least partially arranged in the cavity 9 of the nose cone 8, while also being at least partially arranged in the outer sheath 22. In some embodiments, the implant 13 can be arranged in the delivery device 29 in a radially compressed (e.g., collapsed) configuration and packaged as a kit. In some embodiments, the kit can include the delivery device 29 and the implant 13. In some embodiments, the kit can further include a needle entry tool 35 and / or a guidewire 5. In some embodiments, the delivery device 29 can be single-use. In some embodiments, the delivery device 29 can be reusable. In some embodiments, any of the components and devices described herein may be provided sterile or non-sterile.

[0122] Provided next is a description of the above and referenced method according to some embodiments after a guidewire 5 has been placed through the vasculature and adjacent vasculature desired to be connected via an AVF. Fig.24A - A description of how the delivery device 29 of Figure 24I can deliver the implant 13 percutaneously, however the description provided can be applicable to the delivery devices and methods previously described. In some embodiments, the delivery device 29 can be provided with an implant 13, the implant 13 being in a radially compressed (e.g., collapsed) configuration, slidably disposed on the guidewire sheath 22, slidably disposed within the outer sheath 12, at least partially disposed within the cavity 9 of the nose cone 8, and with the intermediate shaft 16 adjacent its proximal end. In addition, the control knob 26 of the provided delivery device 29 can be in its distal-most position relative to the handle 23 of the delivery device 29 (and in some embodiments, can be locked in the distal-most position via interaction between the distal stop 47 of the control knob 26 and the distal housing stop 53 of the handle 23). In some embodiments, as Figure 24G As shown, the control knob 26 can be prevented from sliding proximally by the presence of a safety clip 39. The nose cone 8 is positioned at the desired AVF position through the lumen of the vascular system (see FIG. Figure 4 ), the delivery device may then be pulled back proximally to engage the nose cone 8 against the proximal wall of the vasculature, as described herein (see Figure 5 ).

[0123] For example, the delivery device can be introduced directly into a patient's vein (e.g., a perforator vein as further described herein), and the nose cone 8 can be advanced into the proximal radial artery. Delivery can occur under ultrasound guidance. The nose cone can be rotated and oriented to the near wall of the radial artery for arterial puncture. The nose cone 8 can be pulled back to align with the near wall of the radial artery. A combination of tactile feedback (pullback resistance) and ultrasound visualization can be used to locate the position on the radial artery wall.

[0124] With the delivery device 29 and its nose cone 8 in this position, the control knob 26 can be moved (e.g., slid) relative to the handle 23 of the delivery device 29 to its most proximal position to proximally retract the outer sheath 12 (see FIG. Figure 6A-6B ). In some embodiments, this can include unlocking the distal stop 47 of the control knob 26 from the distal housing stop 53 of the handle 23 before the control knob 26 can be moved proximally, and can also include locking the control knob 26 in its proximal-most position via interaction between the proximal stop 48 of the control knob 26 and the proximal housing stop 54 of the handle 23. In some cases, the safety clip 39 described above is removed. Proximal retraction of the outer sheath 12 can allow at least a portion of the implant 13 to expand radially within a lumen of an adjacent vasculature (e.g., within a perforating vein), and at least a portion of the implant to expand within the cavity 9 of the nose cone 8. In some embodiments, when moved to its proximal-most position within the handle 23 of the delivery device 29, the control knob 26 can engage with the intermediate shaft connector 50 and lock the intermediate shaft connector 50 to the control knob 26. In some cases, control knob 26 may initially be moved proximally a short distance (eg, 1-2 mm) to ensure that the nose cone remains in place before continuing to move control knob 26 .

[0125] With control knob 26 maintained in its proximal-most position, delivery device 29 may be advanced distally over guidewire 5 to fully release implant 13 from cavity 9 of nose cone 8 and allow the implant to fully radially expand within the lumen of the vasculature (see Figure 8 ). For example, the delivery device 29 can be advanced forward by at least 5 cm. The control knob 26 can be moved (e.g., slid) relative to the handle 23 from its proximal-most position to its distal-most position (in some embodiments, this can include unlocking the proximal stop 48 from the proximal housing stop 54 and again locking the distal stop 47 to the distal housing stop 54), which can cause both the intermediate shaft 16 and the outer sheath 12 to advance distally through the radially expanded implant and engage with the nose cone 8, as described herein (see Fig. 9 The delivery device 29 can be rotated (e.g., rotated about 180 degrees) to create a smooth or substantially smooth transition between the nose cone 8 and the outer sheath 12 (e.g., eliminating any gaps 14 as described herein, see Fig. 10A or Fig. 10B ) and retracted proximally until it is completely removed from the body (see Figure 11-Figure 14 ).

[0126] The construction material of the delivery device 29 can be any material well known for catheter configuration, such as PEEK, HDPE, PeBax, nylon, PTFE, combinations thereof, and others. The diameter and length of the delivery device 29 can be suitable for a specific application. In some embodiments, the profile of the nose cone 8 can be between 6Fr and 9Fr for implants 13 with a diameter between 3mm and 6mm. In some embodiments, the distance between the handle 23 and the nose cone 8 can be between about 15cm and about 30cm. Various lengths and diameters of the delivery device 29 can be used in various embodiments to meet the needs of a specific application. The nose cone 8 can be made of well-known materials suitable for catheters, such as PEEK, HDPE, and polypropylene. In some embodiments, the nose cone 8 can include echogenic features to assist in ultrasound visualization.

[0127] In some embodiments, the delivery device 29 may include a mesh or other wrap disposed around the implant 13 to hold the implant 13 in a radially compressed (e.g., elastically constrained) configuration. In such embodiments, the implant 13 may be released from its radially compressed configuration and expanded to its radially expanded configuration by pulling on the wires or threads of the mesh or wrap, which are configured to tear the mesh or wrap, thereby releasing the implant 13. Furthermore, in such embodiments, the delivery device 29 may not require an outer sheath 12 or an intermediate shaft 16.

[0128] return Figure 1 In the simplified representation of a portion of the vasculature of a human arm shown, a location 7 as a potential area for creating an anastomotic connection may be the location of the branch point between the radial artery near the brachial vein and the radial vein near the perforating vein. Figure 1 As depicted, artery 4 may include the radial artery, deep vein 3 may include the brachial vein and / or the radial vein (e.g., to the left of position 7, the vein may be the brachial vein, and to the right of position 7, the vein may be the radial vein), perforator vein 2 may include the perforator vein, and superficial vein 1 may include the radial vein. Prior to implantation of implant 13, blood flow may be as relative to Figure 1 As described: blood flow in the radial artery (e.g., artery 4) can be from left to right; blood flow in the brachial vein and radial vein (e.g., deep vein 3) can be from right to left; blood flow in the perforator vein (e.g., perforator vein 2) can be from the brachial vein and / or radial vein and diagonally upward and left to the radial vein; and blood flow in the radial vein (e.g., superficial vein 1) can be from right to left.

[0129] In some embodiments, before the guide wire 5 can be placed (e.g. FIG. 2A to FIG. 2D ), several preparatory steps may be taken. Regional anesthesia (e.g., axillary or clavicular block) may be given to the patient. The patient's arm may be positioned on an arm board with 90° abduction. A circumferential skin specimen up to the axilla may be provided.

[0130] return Figure 2A-2D In some embodiments, the guide wire 5 can be percutaneously passed through the wall of the radial vein (e.g., superficial vein 1), through the cubital perforator vein (e.g., perforator vein 2), through the brachial vein or radial vein (e.g., deep vein 3), through the wall of the brachial vein or radial vein (e.g., deep vein 3), through any interstitial tissue between the brachial vein or radial vein and the radial artery (e.g., artery 4), through the wall of the radial artery (e.g., artery 4) and into the radial artery (e.g., artery 4). In some embodiments, the step of placing the guide wire 5 may include the following steps: First, a sterile elastic tourniquet can be applied to the upper arm to increase venous expansion. Second, the patient's skin can be marked on the cranial side to the interface of the cubital perforator vein (e.g., perforator vein 2) and the proximal radial artery (e.g., artery 4) about 2 cm. In the long axis view along the cubital perforator vein, this interface can be found using ultrasound. Third, under ultrasound guidance, a needle (e.g., a 21g echogenic needle) can be advanced at least about 2 cm cranially from the interface of the cubital perforator vein (e.g., perforator vein 2) and the proximal radial artery (e.g., artery 4) into the radial vein (e.g., superficial vein 1). The needle can then be guided transluminally to the septum between the cubital perforator vein (e.g., perforator vein 2) and the proximal radial artery (e.g., artery 4). Fourth, under a lateral ultrasound view, the needle can be advanced from the cubital perforator vein (e.g., perforator vein 2) into the proximal radial artery (e.g., artery 4). Preferably, the approach angle for advancing the needle into the proximal radial artery is directly anterior (i.e., at the 12:00 o'clock position).

[0131] return Fig.15In some embodiments, the implant 13 can be implanted with a distal implant segment 18 (which may also be referred to herein as an arterial implant segment) positioned within the radial artery (e.g., artery 4) and a proximal end segment 19 (which may also be referred to herein as a venous implant segment) extending through the brachial vein or radial vein (e.g., deep vein 3) and the cubital perforator vein (e.g., perforator vein 2). In some cases, the cubital perforator vein (e.g., perforator vein 2) in which the implant 13 is implanted has a diameter of at least about 2.5 mm and a length of at least about 10 mm. In some cases, the proximal radial artery (e.g., artery 4) in which the implant 13 is implanted has a diameter of at least about 2 mm. And in some cases, the distance between the proximal radial artery (e.g., artery 4) and the cubital perforator vein (e.g., perforator vein 2) is less than about 3 mm. This configuration creates a proximal radial artery to cubital perforator vein arteriovenous fistula, which may be advantageous in, for example, a patient requiring hemodialysis. In some cases, an arteriovenous fistula according to some embodiments may be well suited for patients having a minimum proximal radial artery diameter of about 2 mm and a minimum cubital perforator vein diameter of about 2.5 mm. After implant 13 is thus implanted, blood flow may be as relative to Fig.15 As described: blood flow in the radial artery (e.g., artery 4) can be from left to right and enter the side opening or port 60 of the implant 13 as shown (e.g., the side opening or port between the proximal implant segment 19 and the distal implant segment 18), and (i) flow through the proximal end of the distal implant segment 18 and out of the distal end of the distal implant segment 18 to continue through the artery, and (ii) flow through the distal end of the proximal implant segment 19 and out of the proximal end of the proximal implant segment 19 to flow into the cubital perforator vein (e.g., perforator vein 2) and into the radial vein (e.g., superficial vein 1). In some embodiments and with continued reference to Fig.15 , after implantation of the implant 13 as described above, blood flow through the brachial vein and / or radial vein (e.g., deep vein 3) can be at least partially blocked or completely blocked by the proximal implant segment 19. In some embodiments, blocking blood flow through the brachial vein and / or radial vein (e.g., deep vein 3) can advantageously deliver more blood through the radial vein (e.g., superficial vein 1) and further enhance the development of the radial vein for hemodialysis. In some embodiments, the proximal end segment 19 of the implant 13 can advantageously deliver blood from the radial artery (e.g., artery 4) directly into the cubital perforating vein (e.g., perforating vein 2) and / or radial vein (e.g., superficial vein 1) and bypass one or more branch points of the brachial vein and / or radial vein (e.g., deep vein 3). In some embodiments and with continued reference to Fig.15, after implantation of the implant 13 as described above, blood flow through the radial vein (e.g., superficial vein 1) can be from right to left, and can include venous blood as well as arterial blood provided by the implant 13. Arterial blood may flow through the proximal implant segment 19 of the implant 13 due to the pressure difference between the artery 4 and the perforating vein 2 and / or the superficial vein 1 (i.e., arterial blood is at a greater pressure than venous blood, and the fluid will tend to flow from high pressure to low pressure). The flow of arterial blood in the radial vein (e.g., superficial vein 1) attributable to the implant 13 can advantageously cause the radial vein to increase in at least one of its size (e.g., diameter), thickness, or blood flow rate. For example, the flow of arterial blood in the radial vein (e.g., superficial vein 1) attributable to the implant 13 can advantageously cause the diameter of the radial vein to increase to at least about 4 mm, at least about 5 mm, or at least about 6 mm. In another example, the flow rate of arterial blood in the radial vein (e.g., superficial vein 1) due to implant 13 can advantageously cause the blood flow rate in the radial vein (e.g., superficial vein 1) to be at least about 400cc / minute, at least about 500cc / minute, or at least about 600cc / minute. In some embodiments, implant 13 can guide the radial vein (e.g., superficial vein 1) to develop a single access point for hemodialysis (e.g., two needles in the same vein, one for outflow and the other for return). In some embodiments, implant 13 can guide the radial vein (e.g., superficial vein 1) to form a diameter of at least about 6mm and a blood flow rate of at least about 600cc / minute.

[0132] Further references Fig.15 And as described herein, proximal implant section 19 can be angled relative to distal implant section 18. In other words, and as described herein, in some embodiments, the axis (e.g., longitudinal axis) of proximal implant section 19 can be angled relative to the axis (e.g., longitudinal axis) of distal implant section 18. The axis of proximal implant section can be at an angle between about 0 and 90 degrees relative to the axis of distal implant section. In some embodiments, the axis of proximal implant section can be at an angle of about 5 degrees, about 10 degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30 degrees, about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about 55 degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75 degrees, about 80 degrees, about 85 degrees or about 90 degrees relative to the axis of distal implant section.

[0133] Further references Fig.15 and at least reference Fig. 16C , Fig.17A , Fig. 17B , Fig. 17C , Fig.18A , Fig.18B , Fig.18C , Fig.18D , Fig.19A , Fig.19B , Fig. 20A as well as Fig. 20B , and as previously described herein, the implant 13 may include a side opening or port 60 disposed between the proximal implant segment 19 and the distal implant segment 18. The side opening or port 60 may be disposed between the distal end of the proximal implant segment 19 and the proximal end of the distal implant segment 18. As shown in at least some of the figures described above, the side opening or port 60 may be formed by a continuous strut and / or ring 21 of the proximal implant segment 19, a connector strut 20, and a strut including the proximal end of the distal implant segment 18. In some embodiments, the distal implant segment 18 may be positioned downstream of the distal end of the proximal implant segment 19 (e.g., downstream relative to the direction of arterial blood flow, as shown).

[0134] Fig.25 Depicted is a simplified illustration of a portion of a human vasculature indicating potential locations 7 to create an anastomotic connection (e.g., an AVF) between two blood vessels (e.g., an artery 70 and a vein 80) that are located beneath a dermal surface 28, in accordance with some embodiments.

[0135] Figure 26 to Figure 29 A method of percutaneously introducing an intravascular guidewire 5 is depicted according to some embodiments. Figure 26-Figure 29 The methods shown and described may include those previously described herein. Figure 2A-2D Similar steps and / or aspects of the methods described herein. Figure 26-Figure 29 As shown, the guidewire 5 can be introduced percutaneously via a needle access tool 35 as described herein. The needle access tool 35 may include a hollow needle having a proximal port 30 slidably disposed within a sheath 33 and a distal sharp tip 34. The sheath 33 may be connected to a hub 32, which may include a compression element, such as a compression spring 31 disposed between the port 30 and the hub 32. When the port 30 is depressed, the needle tip 34 may be exposed distally of the distal end of the sheath 33 and may be able to pierce tissue such as skin and blood vessels. When the port 30 is not depressed, the spring 31 may decompress and move the needle tip 34 proximally so that it is not exposed. In this configuration, the needle access tool 35 may be advanced in the vasculature, reducing the risk of inadvertent puncture and trauma to the vasculature or other tissues. Using this feature of the needle access tool 35 and appropriate imaging techniques (such as transcutaneous ultrasound, etc.), the needle access tool 35 may first be introduced into the artery 70, such as Fig.26 When the needle tip 34 is retracted within the sheath 33, the needle entry tool 35 can be used as shown. Fig. 27Appropriate imaging is shown being navigated to position 7. When at position 7, the proximal port 30 can be actuated (e.g., depressed) to expose the needle tip 34, and the needle access tool 35 can then be advanced to penetrate the vessel wall and any interstitial tissue between the artery 70 and the vein 80 until the distal end of the sheath 33 enters the lumen of the vein 80. While maintaining this position, the guidewire 5 can be introduced into the proximal port 30 and advanced through the needle access tool 35 until the distal end of the guidewire 5 leaves the distal end of the needle access tool 35 and enters the lumen of the vein 80, as shown. Fig.28 shown. Fig.29 A guidewire 5 is shown having a curvature 6 that may be formed when the guidewire 5 conforms to a particular vascular anatomy after the needle access tool 35 is removed.

[0136] Figure 30-Figure 40 A method of percutaneously implanting an intravascular implant 13 using a delivery device 29 is depicted in accordance with some embodiments. Fig.30 The delivery device 29 is depicted after being placed on the guide wire 5 and slid distally along the guide wire 5 to cause its distal end (e.g., the nose cone 8 at the distal end of the delivery device 29) to pass through the skin surface 28, through the artery 70, through any interstitial space between the artery 70 and the vein 80, and into the vein 80 (e.g., into the lumen of the vein 80). As shown, the implant 13 can be arranged in a radially compressed configuration within the delivery device 29. In some embodiments, the proximal implant segment 19 as described herein can be arranged in a radially compressed configuration within the distal end of the delivery device 29, and the distal implant segment 18 can be arranged in a radially compressed configuration within the distal end of the delivery device 29, however, as shown here and with the use of Figure 3-Figure 15 In contrast to the implant method described above, the distal implant segment 18 can be oriented closer to the distal end of the delivery device 29 than the proximal implant segment 19 (e.g., the implant 13 is reversed relative to its orientation, such as by Figure 3-Figure 15 Thus, as described in Figure 30-Figure 40 As described herein, the distal implant segment 18 will be referred to as the arterial implant segment 18 and the proximal implant segment 19 will be referred to as the venous implant segment 19; however, the convention used thus far herein will be retained when discussing the distal and proximal ends of the implant segments. Fig.30 As shown, the implant 13 can be arranged on the guidewire shaft 22 and radially compressed within the outer sheath 12, wherein the venous implant segment 19 is at least partially arranged within the nose cone 8 (e.g., within the cavity 9 of the nose cone 8) and the arterial implant segment 18 (i.e., the distal end of the arterial implant segment 18 is consistent with previous practice) is adjacent to the distal side of the intermediate shaft 16.

[0137] Fig.31Nose cone 8 is depicted with delivery device 29 advancing through AVF location 7 and within vein 80. Also shown is a gap 14 that may be formed when delivery device 29 follows guidewire curvature 6 and nose cone 8 and outer sheath 12 are no longer coaxial. In some embodiments, gap 14 may be defined as the open space between the proximal opening of nose cone 8 (e.g., proximal opening of cavity 9 of nose cone 8) and the sidewall of outer sheath 12 when outer sheath 12 enters the proximal opening of nose cone 8 (e.g., cavity 9). In some embodiments, gap 14 defines a length and / or diameter of about, at least about, or no more than about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, or more or less of the respective length and / or diameter of the proximal opening of nose cone 8 (e.g., cavity 9), or a range including any two of the foregoing values. Note that and as shown, in order to form gap 14, nose cone 8 may need to be as shown in FIG. Fig.31 The nose cone 8 at the distal end of the delivery device 29 is oriented as shown, for example, with its longer trailing proximal end (formed by the proximal end being angled with the longitudinal length of the nose cone in some of the embodiments shown) oriented on the outside of the bend 6. It is further shown that when the nose cone 8 at the distal end of the delivery device 29 is in a position as shown in FIG. Fig.31 When the curved configuration shown and oriented in the same manner as the gap 14 is formed, an angle 15 between the central (e.g., longitudinal) axis of the nose cone 8 and the central (e.g., longitudinal) axis of the outer sheath 12 can be formed. In some embodiments, the angle 15 can be, for example, about, at least about, or not more than about 5, 10, 15, 20, 25, 30, 35, 40, 45 degrees or more or less, and a range including any two of the foregoing values. To facilitate greater flexibility between the nose cone 8 and the outer sheath 12, the nose cone 8 can have a slit in the wall forming the cavity 9. In some embodiments, to facilitate greater flexibility between the nose cone 8 and the outer sheath 12, the cavity 9 of the nose cone 8 can be oversized relative to the outer diameter of the outer sheath 12. In some embodiments, the curvature 6 of the guidewire 5 can be used to form the angle 15 and the gap 14. Alternative devices for forming the angle 15 and the gap 14 can be used. Alternative embodiments can be, for example, using one, two or more pull wires to deflect the distal end of the delivery device 29 to form the gap 14. Depending on the desired clinical outcome, a variety of steerable and / or deflectable elements may be utilized. In some embodiments, gap 14 may not be formed and / or may not be necessary, for example when nose cone 8 is not provided as in the embodiment of the present invention. Fig. 22B When configured as described and illustrated.

[0138] Fig.32 Depicted is a diagram of a delivery device 29 having been removed from its Fig.31The nose cone 8 engages the proximal wall of the vein 80 after being pulled proximally from the position in the AVF. The engagement between the nose cone 8 (e.g., the proximal end of the nose cone 8) and the proximal wall of the vein 80 can be attributed to the gap 14, which is formed when the delivery device 29 is pushed into a curved configuration, and the tapered proximal end 11 (e.g., the longer tail proximal end) is located outside the curve. In some embodiments, the engagement between the nose cone 8 (e.g., the tapered proximal end 11 of the nose cone 8) and the proximal wall of the vein 80 does not require the gap 14. For example, when the delivery device 29 is pulled proximally, the tapered proximal end 11 of the nose cone 8 can engage the proximal wall of the vein 80. The deformation of the anatomical structure at the AVF location 7 is also depicted, which is a result of the juxtaposition force between the proximal wall of the vein 80 and the tapered proximal end 11 of the nose cone 8. This deformation of the anatomical structure at the AVF location 7 can be visualized by ultrasound and used to verify proper tissue engagement and / or implant placement before delivery.

[0139] Fig.33 Depicted are the initial steps of a first stage of delivery of a radially compressed (e.g., elastically constrained) implant 13 according to some embodiments. As the nose cone 8 remains juxtaposed against the proximal wall of the vein 80, the outer sheath 12 can be retracted proximally so that the radially compressed implant 13 is allowed to expand in a precise position defined by the engagement between the nose cone 8 and the proximal wall of the vein 80. The distal end of the intermediate shaft 16 can remain fixed during retraction of the outer sheath 12 so that the radially compressed implant 13 does not slide proximally during retraction of the outer sheath 12. Also depicted is a venous implant segment 19 being at least partially retained by the cavity 9 of the nose cone 8, which can occur when the outer sheath 12 is retracted (e.g., the outer sheath 12 no longer holds the venous implant segment 19 radially compressed, so that the venous implant segment 19 expands into the cavity 9). In some embodiments and also depicted, a portion of the venous implant segment 19 (e.g., the distal end, but oriented proximally here) is radially expanded at the AVF location 7 due to the radial stiffness of the implant 13. The arterial implant segment 18 is also depicted as still radially compressed within the outer sheath layer 12. To retract the outer sheath 12, the control knob 26 of the delivery device 29 can be slid proximally from its most distal position following the initial delivery of the implant 13, while the handle 23 of the delivery device 29 is held in place to maintain the nose cone 8 in apposition with the proximal wall of the vein 80. In some embodiments, the intermediate shaft 16 can be held stationary during retraction of the outer sheath 12 by the interaction of the intermediate shaft connector 50 with the intermediate shaft connector stop 52 of the delivery device 29 to prevent proximal movement.

[0140] Fig.34Depicted is the continued delivery of the radially compressed (e.g., elastically constrained) implant 13 according to some embodiments, wherein the outer sheath 12 is further retracted until the arterial implant segment 18 is fully released from the outer sheath 12. As shown, when the outer sheath 12 is fully retracted, the arterial implant segment 18 can be radially expanded within the artery 70. When radially expanded within the artery 70, the arterial implant segment 18 can radially engage the wall of the artery 70. It is also shown and in some embodiments that when the outer sheath 12 is fully retracted, the arterial implant segment 18 can be angled relative to the venous implant segment as described herein (e.g., the longitudinal axis of the arterial implant segment 18 can be angled relative to the longitudinal axis of the venous implant segment 19). To further retract the outer sheath 12, the control knob 26 of the delivery device 29 can be further slid proximally to its most proximal position, while the handle 23 of the delivery device 29 is held in place to keep the nose cone 8 juxtaposed with the proximal wall of the vein 80. In some embodiments, the intermediate shaft 16 can be held stationary during retraction of the outer sheath 12 by the interaction of the intermediate shaft connector 50 with the intermediate shaft connector stop 52 of the delivery device 29 and being prevented from moving proximally. Fig.33 and Fig.34 The action of has been described discretely, but in reality, Fig.33 and Fig.34 The actions depicted and described in the figure can follow each other in a smooth manner. For example, the outer sheath 12 can be fully retracted in one motion by the movement (e.g., sliding) of the control knob 26 of the delivery device 29 from its initial most distal position to its most proximal position, which can fully release the implant 13 from the outer sheath 12 in one motion.

[0141] Fig.35Depicted is the delivery of a radially compressed (e.g., elastically constrained) venous implant segment 19 in accordance with some embodiments. As shown, when the nose cone 8 is advanced distally by advancing the guidewire shaft 22 distally (e.g., by advancing the delivery device 29 distally), the venous implant segment 19 can be held in place by the connector struts 20 connected to the arterial implant segment 18, and thus slidably released from the cavity 9 of the nose cone 8. In addition and as shown, when the venous implant segment 19 is released from the cavity 9, it can expand radially within the vein 80. When radially expanding within the vein 80, the venous implant segment 19 can radially engage the wall of the vein 80. As also shown, the arterial implant segment 18 can provide a device for fixing the distal-most portion of the distal edge of the venous implant segment 19 (here oriented as the proximal-most portion of the proximal edge) so that it does not invade the luminal space of the artery 70. Furthermore, as shown, upon radial expansion, the distal end (proximally as oriented here) of the venous implant segment 19 can radially expand at and form a fluid seal with the far wall of the artery 70. The arterial implant segment 18 can also provide radial support to the artery 70 to ensure patency and adequate blood flow in the artery 70 after implantation of the implant 13.

[0142] Fig.36 An initial step of removing the delivery device 29 is depicted according to some embodiments, wherein the outer sheath 12 and intermediate shaft 16 are advanced distally through the delivered (e.g., radially expanded) implant 13 and into the cavity 9 of the nose cone 8. In some embodiments, during this advancement step, the intermediate shaft 16 can guide the outer sheath 12 to help the outer sheath 12 reliably engage the cavity 9 without the outer sheath 12 getting caught on the proximal end 11 of the nose cone 8. To move / advance the outer sheath 12 distally, the control knob 26 of the delivery device 29 can be moved distally (e.g., slid) to its most distal position within the handle 23 while the handle 23 of the delivery device 29 remains in place. Additionally, in some embodiments, the intermediate shaft 16 can be guided and advanced with the outer shaft 12 by engaging the intermediate shaft connector 50 with the control knob 26 after the control knob 26 has been moved (e.g., slid) into its proximal-most position from an earlier step in the delivery process, and the intermediate shaft connector 50 moves distally with the control knob 26 as the control knob 26 moves distally.

[0143] Fig.37Continued removal of the delivery device 29 is depicted according to some embodiments, wherein the delivery system 29 is rotated about its axis, e.g., approximately 180 degrees, such that the proximal portion of the tapered proximal end 11 of the nose cone 8 is inside the curvature 6. In this orientation, the gap 14 can be minimized, eliminated, or substantially eliminated, and there can be a flush contact between the proximal tapered end 11 and the outer sheath 12. This low-profile configuration can facilitate removal of the nose cone 8 without engaging the delivered implant 13 or any anatomical features near the AVF location 7. In some embodiments, the engagement between the outer sheath 12 and the proximal side of the nose cone 8 can be as described herein with respect to Fig. 10B As shown and described, for example, as the outer sheath 12 advances distally, the proximal tapered end of the nose cone 8 can be received within the lumen of the outer sheath 12, creating a substantially smooth transition between the outer sheath 12 and the proximal side of the nose cone 8, and thereby facilitating removal of the delivery device 29.

[0144] Fig.38 Depicted is the continued removal of the delivery device 29 according to some embodiments. As shown, with the proximal retraction of the delivery device 29, the nose cone 8 has passed through a majority of the implant 13 without interference. The implant 13 can have an unconstrained (e.g., radially expanded) delivered internal dimension that is larger than the external dimension of the nose cone 8, so that when removed through the implant 13, the nose cone 8 does not experience excessive resistance or interference to the implant 13. In some embodiments and as described herein with respect to Fig.13 As described, if the gap 14 is formed again during retraction of the delivery device 29 , the delivery device may be rotated again to minimize the gap 14 and / or eliminate the gap 14 to facilitate removal of the delivery device 29 .

[0145] Fig.39 The complete removal of the delivery device 29 according to some embodiments is depicted and only the guidewire 5 remains. Prior to removing the guidewire 5, it may be desirable or advantageous to advance a balloon expansion catheter sized appropriately for the implant 13 and the vasculature to facilitate full expansion of the implant 13. In some embodiments where the venous implant segment 19 and the arterial implant segment 18 have different diameters, cross-sectional areas, and / or circumferences, balloon expansion catheters of different sizes may be used to facilitate full expansion of the venous implant segment 19 and the arterial implant segment 18.

[0146] Fig.40The complete delivery of implant 13 is described, wherein arterial implant segment 18 is in artery 70, venous implant segment 19 is in vein 80, and venous implant segment 19 forms an AVF between artery 70 and vein 80. As described herein, implant 13 can be at least partially anchored in place by any one or more of the following: (i) engagement between the wall of artery 70 and radially expanded arterial implant segment 18; (ii) engagement between the wall of vein 80 and radially expanded venous implant segment 19; (iii) engagement between any anatomical structure (such as any portion of the wall of artery 70 and / or vein 80, etc.) and any anchor and / or barb ( Fig.40 ) and (iv) in embodiments where the implant 13 includes a continuous strut / ring 21, a joint between the far wall of the artery 70 and the continuous strut / ring 21 (e.g., an anastomotic ring) of the implant 13. As shown and as described herein, the distal end of the venous implant segment 19 (such as the proximal end as oriented here) may not obstruct the lumen of the artery 70. In some embodiments, the arterial implant segment 18 may position the venous implant segment 19 via the connector struts 20 so that the distal end of the venous implant segment 19 (such as the proximal end as oriented here) may not obstruct the lumen of the artery 70. In embodiments where the implant 13 includes a continuous strut / ring 21, the continuous strut / ring 21 may form a fluid seal with the far wall of the artery 70. Also as Fig.40 As shown and as described herein, in some embodiments, the venous implant segment 19 (e.g., an axis, such as the longitudinal axis of the venous implant segment, etc.) can be at an angle between about 0 degrees and about 90 degrees relative to the arterial implant segment 18 (e.g., an axis, such as the longitudinal axis of the arterial implant segment, etc.). In addition, the implant 13 can include any one or more of the features, dimensions, characteristics, etc. of any embodiment of the implant 13 as described herein.

[0147] refer to Fig.25 , before implant 13 is implanted, blood flow in artery 70 can be from right to left, and blood flow in vein 80 can be from left to right. Fig.40, after implantation of the implant 13, blood flow can be as follows: blood flow in the artery 70 can be from right to left and enter the side opening or port 60 (e.g., the side opening or port of the implant 13 shown (the side opening or port between the venous implant segment 19 and the arterial implant segment 18), and (i) flow through the proximal end of the arterial implant segment 18 (the distal end as oriented here), and flow out of the distal end of the arterial implant segment 18 (the proximal end as oriented here) to continue through the artery, and (ii) flow through the distal end of the venous implant segment 19 (the proximal end as oriented here) and flow out of the proximal end of the venous implant segment 19 (the distal end as oriented here) to flow into the vein 80 (and, for example, flow from left to right in the vein 80 after leaving the venous implant segment 19). In some embodiments and continuing with reference to Fig.40 , after implantation of the implant 13 as shown, blood flow through the vein 80 can be at least partially blocked or completely blocked by the vein implant segment 19 (e.g., blood flow from left to right to left of the implant 13). Due to the pressure difference between the artery 70 and the vein 80, arterial blood can flow through the vein implant segment 19 of the implant 13. The arterial blood flow in the vein 80 caused by the implant 13 can advantageously cause the vein to increase in at least one of its size (e.g., diameter), thickness, and blood flow rate. For example, the arterial blood flow in the vein 80 caused by the implant 13 can advantageously cause the diameter of the vein 80 to increase to at least about 4mm, at least about 5mm, or at least about 6mm. In another example, the arterial blood flow in the vein 80 caused by the implant 13 can advantageously cause the blood flow in the vein 80 to be at least about 400cc / minute, at least about 500cc / minute, or at least about 600cc / minute. In some embodiments, the implant 13 can guide the vein 80 to develop into a single access point for hemodialysis. In some embodiments, implant 13 can direct vein 80 to have a diameter of at least about 6 mm and a blood flow rate of at least about 600 cc / minute.

[0148] pass Figure 25-Figure 40 The described methods and apparatus may be applied to create an AVF in the vasculature of any relevant region of the human body and for any purpose, including but not limited to creating an access point for hemodialysis. Figure 25-Figure 40 The described methods and devices may be applied to create an AVF between the femoral artery and the femoral vein.

[0149] Fig.41Depicted is a method of bypassing a segment of an artery using an intravascular implant according to some embodiments. An artery 75 is shown with an arterial branch 77 and an arterial obstruction 79. Also shown is a vein 85 adjacent to the artery 75, which in some embodiments may include a venous valve 87. Also shown are two implants 13, implanted so that one (e.g., the left one) creates an AVF between the artery 75 and the vein 85 to the left (e.g., upstream) of the arterial obstruction 79, and one (e.g., the right one) creates an AVF between the artery 75 and the vein 85 to the right (e.g., downstream) of the arterial obstruction 79.

[0150] Prior to implantation of implant 13, blood flow in artery 75 may be from left to right and may be blocked, substantially blocked, or partially blocked by arterial occlusion 79, thereby preventing normal flow of blood through artery 75. When arterial branch 77 is positioned to the left (e.g., upstream) of arterial occlusion 79, arterial branch 77 may receive blood flow from the artery, such as Fig.41 Also, before implantation of the implant 13, blood flow in the vein 85 may be from right to left, and if a venous valve 87 is present, blood may flow through the venous valve 87 in the same direction.

[0151] After implantation of implant 13 as shown, arterial blood flow can be as follows: blood flow in artery 75 can flow from left to right and through the distal end of arterial segment 18 of left implant 13 (according to the convention used herein) and out of the proximal end of arterial segment 18 of left implant 13 (according to the convention used herein), and (i) continue to flow through the artery from left to right and flow through arterial branch 77 or be blocked by arterial blockage 79, and (ii) flow through the distal end of venous segment 19 (according to the convention used herein) and out of the proximal end of venous segment 19 (according to the convention used herein) to flow into vein 85. If venous valve 87 is located in vein 85 between left and right implants 13 as shown, a valve or other device can be used to destroy venous valve 87 before or during implantation of the implant so that arterial blood directed from artery 75 to vein 85 by left implant 13 can continue to pass through the (now destroyed) venous valve 87 after the implant is implanted. To continue arterial blood flow after being directed to vein 85 by the left implant 13 and any interfering venous valves 87 that are disrupted, arterial blood flow may continue as follows: arterial blood may continue through vein 85 after flowing through the venous implant segment 19 of the left implant 13, past any disrupted venous valves 87 (if present), through the proximal end of the venous implant segment 19 of the right implant 13, out the distal end of the venous implant segment 19 of the right implant 13, through the side opening or port 60 of the right implant 13, and (i) to the left toward the arterial obstruction 79 before being blocked by the arterial obstruction 79, and (ii) to the right through the proximal end of the arterial implant segment 18 of the right implant and out the distal end of the arterial implant segment 18 of the right implant and continue through the artery 75. In this manner, two implants 13 may be used to restore arterial blood flow in an artery having an arterial obstruction 79. After implantation of the implant 13 as shown, venous blood flow in the vein 85 can be blocked by the venous implant section 19 of the right implant 13, as shown in FIG. Fig.41 As shown by the return arrow in FIG. 2 . The two implants 13 may be covered with the graft material described herein to facilitate redirection of blood flow, such as relative to Fig.41 discussed.

[0152] Continue to refer Fig.41In some embodiments, the venous implant segment 19 of the implant 13 can cross the venous valve 87 and eliminate the need to destroy the venous valve 87 prior to implantation (e.g., the radial stiffness of the implant alone can be sufficient to open the venous valve 87 and allow the desired blood flow through the venous valve 87). In some embodiments, the delivery device 29 includes sufficient axial stiffness to cross the venous valve 87 and allow the venous implant segment 19 of the implant 13 to be implanted across the venous valve 87. In some embodiments, the two implants 13 can overlap, for example, the venous implant segment 19 of the left implant can be implanted within the venous implant segment 19 of the right implant, and vice versa. In some embodiments, the two implants 13 can be spaced apart to take into account the vascular anatomy (such as any arterial branches 77, etc.) and any arterial obstruction 79. Any of the delivery methods described herein can be used, for example, Fig.41 More than one implant 13 is shown, including relative to Figure 1-Figure 15 The method described, wherein the delivery device can first enter the vein before the artery, and relative to Figure 25-Figure 40 The method described herein, wherein the delivery device can be first delivered to the artery before the vein. In addition, as Fig.41 As shown in and about Fig.41 As described, implant 13 can be used to divert blood flow in the body in a variety of ways, and is not limited to any one of the descriptions provided herein. For example, blood flow can enter or leave the distal end of distal implant segment 18 (i.e., arterial implant segment 18), blood flow can enter or leave the side opening or port 60 between the proximal end of distal implant segment 18 (i.e., arterial implant segment 18) and the distal end of proximal implant segment 19 (i.e., venous implant segment 19), blood flow can enter or leave the proximal end of distal implant segment 18 (i.e., arterial implant segment 18), blood flow can enter or leave the distal end of proximal implant segment 19 (i.e., venous implant segment 19), and blood flow can enter or leave the proximal end of proximal implant segment 19 (i.e., venous implant segment 19).

[0153] As described herein, the delivery system 29 can be used interchangeably with the delivery device 29. Also as described herein, the distal implant segment 18 can be used interchangeably with the arterial implant segment 18. Also as described herein, the proximal implant segment 19 can be used interchangeably with the venous implant segment 19. In some embodiments, the delivery device 29 can be configured to deliver the implant 13 percutaneously into the patient. In some embodiments, the delivery device 29 can be configured to deliver the implant 13 into the patient after surgical resection to the AVF location and / or near the AVF location.

[0154] Fig.42An embodiment of a reaction force mechanism 100 configured to apply a reaction force F to a patient's skin / skin surface 28 during implantation of an implant 13 is depicted. When a proximal implant segment is released from the outer sheath 12, the reaction force mechanism can apply a reaction force to the patient, for example, when the outer sheath 12 is proximally retracted relative to the nose cone 8, to help maintain engagement of the proximal tip 63 / proximal tapered end 11 of the nose cone 8 with the wall of a vein or artery. The reaction force mechanism 100 can be configured in a variety of ways and can interact with a delivery device 29. For example, the reaction force mechanism 100 can include a generally tubular body that can be arranged around the outer sheath 12 and apply a force F between a distal end of a handle 23 of a delivery device 29 as described herein (e.g., at or near the handle nose cone 27) and the patient's skin / skin surface 28. In some embodiments, the reaction force mechanism 100 can be slid over the distal end of the delivery device 29 (e.g., over the nose cone 8 and the outer sheath 12) prior to implanting the implant 13. In some cases, the reaction force mechanism 100 can include two or more parts that can be connected to each other at any point during implantation of the implant 13 and / or as needed on the outer sheath 12. In other embodiments, the reaction force mechanism 100 can include a longitudinal slit / opening that is sized to receive the outer sheath 12 and / or has a longitudinal slit / opening, and the longitudinal slit / opening is deformable so that the reaction force mechanism 100 can be placed on the outer sheath 12 at any point during implantation of the implant 13 and / or as needed. For example, the reaction force mechanism 100 can include a tube that can be deformed in the longitudinal direction to provide a reaction force F against the patient's skin / skin surface 28 when the reaction force mechanism 100 abuts against the distal end of the handle 23 of the delivery device 29 and the patient's skin / skin surface 28. Such a configuration (e.g., a deformable tube) can allow for customization as needed, such as by appropriately cutting the length of the tube based on the length of the outer sheath 12 that remains outside the patient's body (e.g., sized slightly longer than the exposed outer sheath 12 so that the tube can deform and apply such reaction force F). As another example, the reaction force mechanism 100 can include a spring (e.g., a coil spring) that can provide the reaction force F. In some embodiments, the reaction force mechanism 100 can include one or more features that can distribute the reaction force F against the skin / skin surface 28, such as a flange and / or protrusion, etc., which increases its outward radial dimension where it meets the skin / skin surface 28.

[0155] The foregoing description and examples have been set forth merely to illustrate the present disclosure and are not intended to be limiting. Each of the disclosed aspects and embodiments of the present disclosure may be considered individually or in combination with other aspects, embodiments, and variations of the present disclosure. In addition, unless otherwise indicated, the steps of the method of the present disclosure are not limited to any specific execution order. Those skilled in the art may conceive of modifications of the disclosed embodiments that incorporate the spirit and substance of the present disclosure, and such modifications are within the scope of the present disclosure.

[0156] As used herein, directional terms (such as "top", "bottom", "horizontal", "vertical", "longitudinal", "lateral", and "end", etc.) are used in the context of the illustrated embodiments. However, the present disclosure should not be limited to the orientations shown. In fact, other orientations are possible and are within the scope of the present disclosure. Terms used in this article that refer to circular shapes (such as, diameter or radius, etc.) should be understood as not requiring a perfect circular structure, but should apply to any suitable structure having a cross-sectional area that can be measured from one side to the other. Terms generally related to shape (such as "circular" or "cylindrical" or "semi-circular" or "semi-cylindrical" or any related or similar terms, etc.) are not required to strictly conform to the mathematical definition of a circle or cylinder or other structure, but can cover reasonably approximate structures.

[0157] Conditional language used herein, such as, among others, "may," "might," "could," "for example," and the like, unless expressly stated otherwise or otherwise understood in the context in which it is used, is generally intended to convey that some embodiments include (and other embodiments do not include) certain features, elements, and / or states. Thus, such conditional language is generally not intended to imply that features, elements, blocks, and / or states are in any way essential to one or more embodiments, or that one or more embodiments necessarily include instructions for determining whether such features, elements, and / or states are included or will be performed in any particular embodiment, with or without author input or prompting.

[0158] Unless specifically stated otherwise, conjunctive language (such as the phrase "at least one of X, Y, and Z") is otherwise understood, depending on the context, to be generally used to convey that an item, term, etc. can be X, Y, or Z. Thus, such conjunctive language is generally not intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0159] As used herein, the terms "approximately," "about," and "substantially" refer to an amount that is close to the described amount and still performs the desired function or achieves the desired result. For example, in some embodiments, as the context may dictate, the terms "approximately," "about," and "substantially" may refer to an amount that is within 10% of or less than the described amount. As used herein, the term "generally" refers to a value, amount, or characteristic that primarily includes or tends toward a particular value, amount, or characteristic. As an example, in certain embodiments, as the context may dictate, the term "substantially parallel" may refer to something that deviates from exactly parallel by less than or equal to 20 degrees.

[0160] When the term "about" is used before a range of two values, this is intended to include ranges between about the first value and about the second value, as well as ranges from the specified first value to the specified second value.

[0161] Unless expressly stated otherwise, articles such as "a" or "an" should generally be interpreted as including one or more of the described items. Thus, phrases such as "the apparatus is configured to" are intended to include one or more of the stated apparatuses. Such one or more of the stated apparatuses may be collectively configured to implement the stated statements. For example, "a processor configured to perform statements A, B, and C" may include a first processor configured to perform statement A working in conjunction with a second processor configured to perform statements B and C.

[0162] The terms "comprising," "including," "having," and the like are synonymous and used in an inclusive manner and do not exclude additional elements, features, actions, operations, and the like. Likewise, the terms "some," "some," and the like are synonymous and used in an open manner. Moreover, the term "or" is used in its inclusive sense (and not in its exclusive sense) so that, for example, when used to connect a list of elements, the term "or" refers to some, some, or all of the elements in the list.

[0163] In general, the language of the claims should be interpreted broadly based on the language employed in the claims.The language of the claims is not limited to the non-exclusive embodiments and examples shown and described in the present disclosure or discussed during the prosecution of the application.

[0164] Although systems, devices and methods for intravascular implants and accurate placement thereof have been disclosed in the context of certain embodiments and examples, the present disclosure extends beyond these specifically disclosed embodiments to other alternative embodiments and / or uses of embodiments and some modifications and equivalents thereof. Various features and aspects of the disclosed embodiments may be combined or replaced with one another to form different modes of systems, devices and methods for intravascular implants and accurate placement thereof. The scope of the present disclosure should not be limited by the specific disclosed embodiments described herein.

[0165] Certain features described in this disclosure in the context of separate implementations may be implemented in combination in a single implementation. Conversely, various features described in the context of a single implementation may be implemented in multiple implementations, either individually or in any suitable subcombination. Although features may be described herein as functioning in certain combinations, in some cases, one or more features from a claimed combination may be removed from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.

[0166] Although the method and apparatus described herein may be susceptible to different modifications and alternative forms, its specific examples have been shown in the drawings and are described in detail herein. However, it should be understood that the present invention is not limited to the specific form or method disclosed, but on the contrary, the present invention will cover all modifications, equivalents and replacements falling within the spirit and scope of the various embodiments described and the appended claims. Further, the disclosure of any specific features, aspects, methods, attributes, characteristics, qualities, attributes, elements, etc. in conjunction with the embodiments herein can be used in all other embodiments set forth herein. Any method disclosed herein does not need to be performed in the described order. Depending on the embodiment, one or more actions, events or functions of any one of the algorithms, methods or processes described herein may be performed in different orders, may be added, merged or completely omitted (for example, not all described actions or events are necessary for the practice of the algorithm). In some embodiments, actions or events may be performed concurrently, for example, by multithreading, interrupt processing or multiple processors or processor cores or on other parallel architectures, rather than sequentially. In addition, no element, feature, frame or step, or group of elements, features, frames or steps is necessary or indispensable for each embodiment. Furthermore, all possible combinations, subcombinations, and rearrangements of systems, methods, features, elements, modules, blocks, etc. are within the scope of the present disclosure. Unless specifically stated otherwise, or otherwise understood in the context of use, the use of sequential or chronological language such as "then," "next," "after," "subsequently," etc. is generally intended to facilitate the flow of the text and is not intended to limit the order of operations performed. Thus, some embodiments may be performed using the sequence of operations described herein, while other embodiments may be performed following a different sequence of operations.

[0167] In addition, although the operations may be depicted in the drawings or described in a particular order in the specification, these operations do not need to be performed in the particular order or sequence shown, nor do they need to perform all operations to achieve the desired results. Other operations not shown or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, simultaneously, or between any of the operations. In addition, operations may be rearranged or reordered in other implementations. In addition, the separation of various system components in the embodiments described herein should not be understood as requiring such separation in all embodiments, and it should be understood that the described components and systems may generally be integrated into a single product or packaged into multiple products. In addition, other implementations are also within the scope of the present disclosure.

[0168] Some embodiments have been described in conjunction with the accompanying drawings. Certain figures are drawn and / or shown to scale, but such scale should not be limiting, as dimensions and ratios other than those shown are also contemplated and within the scope of the embodiments disclosed herein. Distances, angles, etc. are merely illustrative and do not necessarily have an exact relationship to the actual size and layout of the device shown. Components may be added, deleted, and / or rearranged. In addition, the disclosure of any particular features, aspects, methods, attributes, characteristics, qualities, properties, elements, etc. associated with various embodiments herein may be used for all other embodiments set forth herein. In addition, any method described herein may be practiced using any device suitable for performing the steps.

[0169] The methods disclosed herein may include certain actions taken by a practitioner; however, the methods may also include any third-party instructions for such actions, whether explicit or implicit. For example, an action such as "positioning an electrode" includes "instructing the positioning of an electrode."

[0170] In summary, various embodiments and examples of intravascular implants, devices, and methods for precise placement have been disclosed. Although systems, devices, and methods for intravascular implants and precise placement thereof have been disclosed in the context of these embodiments and examples, the disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or other uses of the embodiments, as well as certain modifications and equivalents thereof. The disclosure expressly contemplates that the various features and aspects of the disclosed embodiments may be combined or substituted with one another. Therefore, the scope of the disclosure should not be limited to the specific disclosed embodiments described herein, but should be determined only by a fair reading of the following claims.

[0171] The ranges disclosed herein also include any and all overlaps, subranges, and combinations thereof. Language such as "at most," "at least," "greater than," "less than," "between," and the like includes the referenced numbers. Numbers preceded by terms such as "about" or "approximately" include the referenced numbers and should be interpreted as the case may be (e.g., as accurately as possible in the circumstances, such as ±5%, ±10%, ±15%, etc.). For example, "about 1V" includes "1V." Phrases preceded by terms such as "substantially" include the referenced phrases and should be interpreted as the case may be (e.g., as reasonably possible in the circumstances). For example, "substantially vertical" includes "vertical." Unless otherwise noted, all measurements are made under standard conditions, including temperature and pressure.

Claims

1. An implant configured to be delivered percutaneously into an arm of a patient for forming an arteriovenous fistula, the implant comprising: a proximal implant section comprising a proximal end, a distal end, and an axis extending through the proximal implant section; a distal implant segment connected to the proximal implant segment, the distal implant segment comprising a proximal end, a distal end, and an axis extending through the distal implant segment; as well as a side opening located between a distal end of the proximal implant section and a proximal end of the distal implant section; Wherein, the proximal implant section is configured to bend or bend at least 90 degrees relative to the distal implant section in a direction away from the side opening.

2. The implant according to claim 1, wherein The side opening is configured to allow blood to flow through the side opening (i) along the proximal implant segment in a first direction from the distal end of the proximal implant segment to the proximal end of the proximal implant segment, and (ii) along the distal implant segment in a second direction from the proximal end of the distal implant segment to the distal end of the distal implant segment.

3. An implant according to any one of the preceding claims, wherein The proximal implant section can be bent or flexed at least 180 degrees relative to the distal implant section in a direction away from the side opening.

4. An implant according to any one of the preceding claims, wherein The proximal implant section includes a series of rows of struts arranged generally circumferentially around an axis of the proximal implant section, the series of rows of struts of the proximal implant section being connected to each other by one or more axially extending struts arranged generally along the axis of the proximal implant section.

5. The implant according to claim 4, wherein Adjacent rows of struts of the proximal implant section are connected by no more than one axially extending strut.

6. The implant according to claim 4 or 5, wherein: Each row of struts includes a row of corrugated struts.

7. An implant according to any one of claims 4 to 6, wherein The distal implant segment includes a series of rows of struts arranged circumferentially at least partially around an axis of the distal implant segment, the series of rows of struts of the distal implant segment being connected to each other by one or more axially extending struts arranged generally along the axis of the distal implant segment.

8. The implant according to claim 7, wherein The series of rows of struts of the distal implant section are connected to each other by at least one strut that extends further axially than the series of rows of struts of the proximal implant section to provide greater flexibility of the proximal implant section relative to the distal implant section.

9. An implant according to any one of claims 4 to 8, wherein A majority or all of the one or more axially extending struts of the proximal implant section are located on a side of the proximal implant section that is aligned with the location of the side opening.

10. An implant according to any one of the preceding claims, wherein The proximal implant section has a greater flexibility than the distal implant section.

11. An implant according to any one of the preceding claims, wherein The proximal implant segment includes a tubular body having a flow lumen extending between a proximal end of the proximal implant segment and a distal end of the proximal implant segment.

12. An implant according to any one of the preceding claims, wherein The proximal implant section is linearly straight.

13. An implant according to any one of the preceding claims, wherein The distal implant segment includes an at least partially tubular body extending between a proximal end of the distal implant segment and a distal end of the distal implant segment.

14. An implant according to any one of the preceding claims, wherein The distal implant segment includes a tubular body having a flow lumen extending between a proximal end of the distal implant segment and a distal end of the distal implant segment.

15. An implant according to any one of the preceding claims, wherein The distal implant section is linearly straight.

16. An implant according to any one of the preceding claims, wherein The proximal implant segment and the distal implant segment include expandable bodies, and wherein the proximal implant segment is angularly oriented relative to the distal implant segment when the proximal implant segment and the distal implant segment are fully expanded in a rest configuration.

17. An implant according to any one of the preceding claims, wherein The proximal implant section has an axial length that is greater than an axial length of the distal implant section.

18. An implant according to any one of the preceding claims, wherein The distal end of the proximal implant section includes an anastomotic ring.

19. An implant according to any one of the preceding claims, wherein One or both of the proximal implant segment and the distal implant segment include one or more anchors configured to anchor one or both of the proximal implant segment and the distal implant segment against a wall of a vein or artery.

20. An implant according to any one of the preceding claims, wherein One or both of the proximal implant section and the distal implant section are covered with a graft material.

21. An implant according to any one of the preceding claims, wherein The implant is configured to collapse to a collapsed configuration for percutaneous delivery into an arm of the patient, and the implant is configured to expand from the collapsed configuration to an expanded configuration for implantation between a vein and an artery of the patient.

22. An implant according to any one of the preceding claims, wherein The proximal implant section and the distal implant section are formed from a single unitary body.

23. An implant according to any one of the preceding claims, wherein The proximal implant section and the distal implant section include a metal frame.

24. An implant according to any one of the preceding claims, wherein The proximal implant section and the distal implant section are formed from a single laser cut hypotube.

25. The implant of any of the preceding claims, further comprising one or more axially extending struts connecting the distal end of the proximal implant section to the proximal end of the distal implant section.

26. A method of forming an arteriovenous fistula in a patient, comprising: delivering an intraluminal implant in a collapsed configuration into a patient within a sheath, the sheath constraining the intraluminal implant at a distal end of the sheath, the intraluminal implant comprising a proximal implant segment and a distal implant segment, wherein the proximal implant segment is connected to the distal implant segment, wherein a portion of the distal end of the sheath is delivered into a proximal cavity of a nose cone in the patient, and wherein the nose cone comprises an angled proximal end, the angled proximal end comprising a proximal-most tip spaced radially outward from an inner diameter of the proximal cavity; extending the intraluminal implant within the sheath between a vein and an artery, wherein the proximal implant segment at least partially extends through one of the vein and the artery, and the distal implant segment and nose cone are positioned within the other of the vein and the artery distal from the proximal implant segment; retracting the nose cone and sheath proximally so that a proximal-most tip of the nose cone engages a wall of the vein or artery in which the distal implant segment is positioned; retracting the sheath proximally relative to the nose cone to radially expand the proximal implant segment and engage a wall of the vein or artery in which the proximal implant segment extends; and The nose cone is advanced distally relative to the distal implant segment to radially expand the distal implant segment and engage a wall of the vein or artery in which the distal implant segment is positioned.

27. The method according to claim 26, wherein: The proximal-most tip is radially spaced outward from a virtual protrusion of the inner diameter of the proximal cavity to form a radial gap between the proximal-most tip and the virtual protrusion of the inner diameter, the radial gap allowing the proximal-most tip to engage the wall of the vein or artery in which the distal implant segment is positioned.

28. The method according to claim 26 or 27, wherein: The proximal end of the nose cone includes, in longitudinal cross-section, a first surface extending radially proximally from an inner side of the proximal cavity and radially outward to the proximal-most tip, and a second surface extending distally and radially outward from the proximal-most tip to an outer diameter of the nose cone.

29. The method according to any one of claims 26 to 28, wherein: The proximal implant section radially expands to engage a wall of a vein, and the distal implant section radially expands to engage a wall of an artery.

30. The method of claim 29, wherein: The intraluminal implant includes a side opening between the distal end of the proximal implant segment and the proximal end of the distal implant segment, so that after the proximal implant segment radially expands to engage the wall of the vein and the distal implant segment radially expands to engage the wall of the artery, blood flowing through the artery enters the side opening and (i) flows through the proximal end of the distal implant segment and the distal end of the distal implant segment to continue flowing through the artery, and (ii) flows through the distal end of the proximal implant segment and flows out of the proximal end of the proximal implant segment to flow into the vein.

31. The method of any one of claims 26 to 30, further comprising applying a reaction force to the patient when the sheath is retracted proximally relative to the nose cone to help maintain engagement of the proximal tip of the nose cone with the wall of the vein or the artery while releasing the proximal implant segment from the sheath.

32. The method according to claim 31, wherein: The reaction force is applied by a reaction force mechanism configured to apply the reaction force to the patient's skin.

33. An intraluminal implant comprising one or more of the features described above.

34. A delivery system for delivering an intraluminal implant, comprising one or more of the features described above.

35. A method for delivering an intraluminal implant comprising one or more of the features described above.

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