CN116709998A - Accurately placed endovascular implants, devices and methods - Google Patents

Abstract

Various systems, devices, and methods for intravascular implants and precise placement thereof are disclosed. The disclosed implant includes a proximal implant portion, a distal implant portion, a connecting strut connecting the proximal implant portion to the distal implant portion, and a side opening between the proximal implant portion and the distal implant portion. By placing the proximal and distal implant segments within the vessels to be connected, the disclosed implants can be used to create arteriovenous fistulae or to connect one vessel of the body to another. The disclosed implant may include one or more anchors for securing the implant in place relative to the vessel of the body to which it is attached. The disclosed implants may also include a continuous strut or ring at the distal edge of the proximal implant portion. Methods for precise percutaneous placement of the disclosed implants, as well as devices for percutaneous delivery, are also disclosed.

Description

Accurately placed endovascular implants, devices and methods

Cross Reference to Related Applications

The present application claims priority from U.S. provisional patent application Ser. No. 63/111,548, filed 11/9/2020, and U.S. provisional patent application Ser. No. 63/245,114, filed 9/2021, which are incorporated herein by reference in their entireties for all purposes.

Technical Field

Some aspects herein relate to intravascular implant systems, methods, and devices that provide precise percutaneous placement in the vasculature.

Background

A number of interventional endovascular procedures have been developed and practiced that require accurate placement of implants such as endovascular stents, filters, and stent-grafts (stent grafts), etc. These endovascular procedures treat diseases such as vascular occlusive disease, vascular aneurysmal disease, and other vascular system abnormalities. They can also treat hypertension, including portal hypertension and systemic hypertension, by diverting blood flow from the hypertension vasculature to the low pressure venous system. Another treatment that may be performed by endovascular surgery is to create an arteriovenous fistula by placing a vascular implant between a vein and an artery, thereby creating a vascular access for hemodialysis.

These endovascular implantation procedures typically rely on expensive radiological imaging (e.g., fluoroscopy) and high skill of the operator 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 media into the patient, which can cause unnecessary stress on the renal system. Percutaneous ultrasound imaging does not provide the required image resolution to ensure accurate positioning during these procedures. There is a need for improved implants and procedures.

Hemodialysis may benefit from improved implants and methods, among other things. Hemodialysis is a life-saving treatment for renal failure, using a machine called a dialyzer to filter the patient's blood in vitro. During surgery, vascular access is required to remove and reflux blood. During hemodialysis, blood from a patient will flow from one point of the access (e.g., from a needle that pierces the access vein), through a tube, to a dialyzer where waste and excess fluid are filtered out, and then through a different tube back to a separate point of the access (e.g., by piercing to the same access vein or another needle in another access vein) in order to return it to the patient. Vascular access allows a large volume of blood to flow continuously during hemodialysis treatment in order to filter as much blood as possible during surgery. Vascular access generally includes two types: long term use (including arteriovenous fistulae and arteriovenous grafts) and short term use (including venous catheters).

An Arteriovenous (AV) fistula for hemodialysis is typically a connection established between an artery and a vein by a vascular surgeon. In creating an atrioventricular fistula, a vascular surgeon connects an artery of a patient to a vein of the patient. AV fistulae are typically placed in the forearm or upper arm, and for ease of access, it is desirable to connect an artery (located intramuscularly near the deep vein) to a superficial vein (located on top of/outside of the muscle and closer to the surface). AV fistulae expose veins to increased pressure and blood flow, causing them to become larger and stronger. The enlarged vein provides easier and more reliable targets for vascular access, increased blood flow allows a single venous access and more blood to be filtered, and increased strength enables the vein to handle repeated needle insertions for continuous treatment and prevents the vein from collapsing during surgery.

AV grafts for hemodialysis are typically annular plastic tubes implanted in a patient (e.g., they do not leave the skin), which connect arteries and veins, and are surgically installed by a vascular surgeon. In contrast to the patient's vein being used for vascular access during hemodialysis, AV grafts are used to access the vasculature (e.g., an access needle is passed through a graft tubing rather than the patient's vein).

Venous catheters used in hemodialysis are tubes inserted into veins of the patient's neck, chest or leg near the groin, and are typically used only for short-term hemodialysis, as this approach increases the risk of sepsis and mortality. The catheter is split into two parts after exiting the body to achieve two typical connections for hemodialysis treatment (e.g., blood outflow, filtered blood inflow). If the patient's disease progresses 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 of development/maturation for hemodialysis; in such a case, an intravenous catheter may be required until a longer-term vascular access is established.

Among the methods of creating hemodialysis access, AV fistulae are preferred over other types mentioned because they provide good blood flow for dialysis, last longer, and have a lower likelihood of infection or thrombus than other types of access. Despite being the preferred method, current practices for creating AV fistulae still suffer from drawbacks. One of the major drawbacks is the need for vascular surgeons to surgically create AV fistulae, which require appropriate personnel, facilities and infrastructure to perform.

Newer methods for creating AV fistulae, such as by catheter electrocautery, may allow for less invasive methods, 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 an AV fistula in adjacent vessels by the catheter electrocautery approach, the AV fistula will form between an artery and a deep vein, rather than directly between an artery and a superficial vein, which is the desired type of puncture vein (accessvein) for hemodialysis. While the venous perforation does extend between and connect the deep veins to the shallow veins, the deep veins also have multiple branch points in the anatomical region commonly used to form AV fistulae. Thus, AV fistulae produced by catheter electrocautery may disperse blood flow from an artery through multiple venous branches, and only a portion may be directed to a desired shallow vein, which may be insufficient to induce the required anatomical changes in the shallow vein or to provide the blood flow required for a hemodialysis treatment procedure, as described above. Auxiliary procedures, such as ligation and embolization, may be required on the connected branch veins to direct blood from the arterial to the desired shallow vein, which may delay the availability of long-term vascular access to the patient and require prolonged access through the intravenous catheter, exposing the patient to increased risk of such access. There remains a need for improved methods, systems, and devices for creating an atrial AV fistula for hemodialysis.

Disclosure of Invention

The embodiments disclosed herein each have several aspects, none of which individually contribute to the desired attributes of the present disclosure. Without limiting the scope of this disclosure, its more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section entitled "detailed description of certain embodiments" one will understand how the features of the embodiments described herein provide advantages over existing systems, devices, and methods.

In some embodiments, disclosed herein is a system for forming an arteriovenous fistula in an arm of a patient, the system comprising: an intravascular delivery device and an endoluminal implant, the intravascular delivery device configured to be advanced into an arm of the patient, wherein the intravascular delivery device is configured to be advanced into a superficial vein, into a through-branch vein, into a deep vein, and into an artery adjacent to the deep vein; wherein the endovascular delivery device is configured to deliver the endoluminal implant in a radially compressed configuration into the arm of the patient, the endoluminal 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 proximal implant segment extends through the through-branch vein and the deep vein, wherein the proximal end of the proximal implant segment is positioned within the through-branch vein; and a distal implant segment connected to the proximal implant segment, the distal implant segment being releasable from the intravascular delivery device to transition from a radially compressed configuration to a radially expanded configuration in which the distal implant segment is positioned within the artery, wherein the distal end 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 through-branch 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 divert flow from the artery into the shallow vein.

In the above-described system or other embodiments described herein, one or more of the following features may also be provided. In some embodiments, the distal implant segment is configured to anchor to a wall of an artery. In some embodiments, the distal implant segment includes a tubular body configured to provide radial support to the artery. In some embodiments, the proximal implant segment includes a tubular body configured to radially engage a wall of the through-the-branch vein. In some embodiments, the distal end of the proximal implant segment is configured to be secured to a wall of an artery. In some embodiments, the distal end of the proximal implant segment includes an anchor configured to anchor to the arterial wall. In some embodiments, one or both of the proximal implant section and the distal implant section are covered with a graft material. In some embodiments, the implant includes a side opening between a distal end of the proximal implant section and a proximal end of the distal implant section, wherein blood flowing through the artery enters the side opening when the proximal implant section is in a radially expanded configuration extending through the through-the-branch vein and the deep vein and the distal implant section is in a radially expanded configuration within the artery, and (i) flows through the proximal end of the distal implant section and out of the distal end of the distal implant section, and (ii) flows through the distal end of the proximal implant section and out of the proximal end of the proximal implant section. In some embodiments, the distal end of the proximal implant section comprises an anastomotic ring. In some embodiments, the distal end of the proximal implant segment is configured at an angle between about 0 degrees and about 90 degrees relative to the axis of the distal implant segment. In some embodiments, the distal implant segment is connected to the proximal implant segment by at least one connecting strut. In some embodiments, the delivery device includes a sheath configured to constrain the endoluminal implant within the distal end of the sheath in a radially compressed configuration. In some embodiments, the delivery device further comprises a nose cone advanceable into the artery, and wherein the distal end of the sheath is configured to be inserted into the cavity of the nose cone for advancement with the nose cone into the artery. In some embodiments, the nose cone includes a tapered proximal end configured to engage a proximal wall of an artery. In some embodiments, the delivery device is configured such that after the distal end of the sheath is advanced into the artery with the nose cone: the sheath is retractable in a proximal direction relative to the nose cone to expand the proximal implant section within the deep vein and the through-branch vein; and the nose cone may be advanced distally relative to the distal implant segment after the proximal implant segment is expanded intravenously in the deep vein and the perforator to expand the distal implant segment intra-arterially. In some embodiments, the delivery device is configured such that after the distal implant segment expands within the artery, the sheath can be advanced through the expanded proximal implant segment and the expanded distal implant segment engaged with the burr to facilitate removal of the burr with the sheath from the artery. In some embodiments, the delivery device further comprises a guidewire shaft configured to be advanced over the guidewire, wherein the nose cone is secured to the guidewire shaft.

In some embodiments, disclosed herein is a method of forming an arteriovenous fistula in an arm of a patient, comprising: delivering an endoluminal implant in a contracted configuration into a patient, the endoluminal implant comprising a proximal implant section and a distal implant section, wherein the proximal implant section is connected to the distal implant section; extending the endoluminal implant between a deep vein and an artery adjacent the deep vein, wherein the proximal implant section extends through a perforator vein and the deep vein and the distal implant section is positioned within the artery; and radially expanding the proximal implant segment to engage the proximal implant segment with the wall of the through-branch vein and radially expanding the distal implant segment to engage the distal implant segment with the wall of the artery and provide radial support for the artery such that blood flowing through the artery passes from the artery into a shallow vein connected to the through-branch vein.

In the methods described above or other embodiments described herein, one or more of the following features may also be provided. In some embodiments, the endoluminal implant comprises a side opening between the distal end of the proximal implant section and the proximal end of the distal implant section such that after the proximal implant section radially expands to engage the wall of the through-branch vein and the distal implant section 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 section and the distal end of the distal implant section to continue flowing through the artery, and (ii) flows through the distal end of the proximal implant section and out the proximal end of the proximal implant section to flow into the through-branch vein and into the superficial vein. In some embodiments, the proximal implant section and the distal implant section comprise tubular bodies. In some embodiments, the method further comprises anchoring the distal end of the proximal implant segment to the arterial wall. In some embodiments, the proximal implant segment is angled relative to the axis of the distal implant segment after the proximal implant segment is radially expanded to engage the wall of the through-the-branch vein and the distal implant segment is radially expanded to engage the wall of the artery. In some embodiments, the proximal implant segment is at an angle between about 0 degrees and about 90 degrees relative to the axis of the distal implant segment. In some embodiments, the endoluminal implant is delivered into the patient's body within a sheath that constrains the endoluminal implant at the distal end of the sheath. In some embodiments, the distal end of the sheath is advanced into an artery within the cavity of the nose cone. In some embodiments, the proximal implant segment is released from the sheath to radially expand into engagement with the wall of the through-the-branch vein by proximally retracting the sheath relative to the nose cone. In some embodiments, the distal implant segment radially expands into engagement with the arterial wall by distally advancing the nose cone relative to the distal implant segment. In some embodiments, the method further comprises distally advancing the sheath through the radially expanded proximal implant section and the radially expanded distal implant section into engagement with the burr, and proximally retracting the sheath through the radially expanded proximal implant section and the radially expanded distal implant section into engagement with the burr. In some embodiments, the nose cone includes a tapered proximal end that engages the wall of the artery while the sheath is retracted proximally to release the proximal implant section. In some embodiments, the burr rotates within the artery after the burr has been advanced distally to release the distal implant section and before the sheath engaged with the burr is retracted proximally through the radially expanded proximal implant section and the radially expanded distal implant section.

In some embodiments, disclosed herein is a method of producing an arteriovenous fistula, comprising: entering the superficial vein; advancing the access tool into the shallow vein, into the through-branch vein, and into the deep vein; advancing the access tool through the luminal wall of the deep vein, through the interstitial space or any interstitial space, and through the adventitial wall of the artery (also sometimes referred to herein as the "deep artery"); advancing a guidewire through an access tool into an artery; retracting the access tool over the guidewire; and/or advancing the device (also referred to herein as a "delivery device") over the guidewire such that the distal end of the device is within the artery and a more proximal segment of the device spans the interstitial space or any interstitial space.

In the methods described above or other embodiments described herein, one or more of the following features may also be provided. In some embodiments, the method may include wherein advancing the access tool through the lumen wall of the deep vein, through the interstitial space or any interstitial space, and through the adventitial wall of the artery includes actuating a port proximal to the proximal end of the access tool, thereby distally extending a sharpened tip from the distal end of the access tool. In some embodiments, actuating the port includes depressing the port and compressing a spring element operatively connected to the sharpened tip. In some embodiments, the method further comprises releasing the port, allowing the spring element to recoil and causing the sharpened tip to retract proximally into the distal end of the access tool. In some embodiments, the device or delivery device comprises a nose cone. In some embodiments, the nose cone includes a proximal tapered end, a central lumen, a distal tapered end, and a longitudinal axis. In some embodiments, the device or delivery device comprises a flexible sheath comprising a longitudinal axis. In some embodiments, the implant is carried within the flexible sheath in a radially compressed configuration. In some embodiments, after advancing the device or delivery device over the guidewire, the distal end of the flexible sheath is positioned 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 sidewall 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% to 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 sidewall of the flexible sheath. In some embodiments, the method further comprises proximally withdrawing the nose cone and the flexible sheath such that the nose cone engages the proximal wall of the artery. In some embodiments, the method further comprises proximally withdrawing the sheath, thereby allowing the proximal section of the implant to transition from the radially compressed configuration to the radially expanded configuration. In some embodiments, proximally withdrawing the sheath releases the anchor engaging the proximal section of the implant relative to the proximal wall of the artery. In some embodiments, the distal section of the implant is held within the nose cone in a radially compressed configuration, while the proximal section of the implant is in a radially expanded configuration. In some embodiments, the method further comprises advancing the nose cone relative to the distal section of the implant, thereby transitioning the distal section of the implant to a radially expanded configuration. In some embodiments, advancing the nose cone releases an anchor that engages a proximal segment of the implant relative to a proximal wall of the artery. In some embodiments, proximally withdrawing the sheath releases the anchor engaging the proximal segment of the implant relative to the proximal wall of the artery. In some embodiments, the method further comprises advancing the sheath distally through the distal section of the implant in a radially enlarged configuration, thereby engaging the nose cone. In some embodiments, the method further comprises rotating the nose cone about its longitudinal axis. In some embodiments, the method further comprises proximally withdrawing the nose cone and flexible sheath from the artery, or any interstitial space, deep vein, through-branch vein, and shallow vein, leaving the implant in place.

In some embodiments, disclosed herein is a method of creating a fistula, comprising: advancing the access tool through the lumen wall of the first lumen, through the interstitial space or any interstitial space, and through the outer wall of the second lumen; advancing the guidewire through the access tool into the second lumen; retracting the access tool over the guidewire; and/or advancing the device (also referred to herein as a "delivery device") over the guidewire such that the distal end of the device is within the second lumen and the more proximal section of the device spans the interstitial space or any interstitial space, wherein the device comprises a burr comprising a proximal tapered end, a central lumen, a distal tapered end, and a longitudinal axis, and a flexible sheath comprising a longitudinal axis, wherein after advancing the device over the guidewire, the distal end of the flexible sheath is within the central lumen of the burr, and when the flexible sheath enters the central lumen of the burr at the proximal tapered end of the burr, a gap is formed between the proximal tapered end of the burr and the sidewall of the flexible sheath, and wherein the longitudinal axis of the flexible sheath is non-coaxial with the longitudinal axis of the burr.

In the methods described above or other embodiments 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% to 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 comprises proximally withdrawing the burr and the flexible sheath such that the burr engages the proximal wall of the second lumen. In some embodiments, the implant is carried within the flexible sheath in a radially compressed configuration. In some embodiments, the method further comprises proximally withdrawing the sheath, thereby allowing the proximal section of the implant to transition from the radially compressed configuration to the radially expanded configuration. In some embodiments, proximally withdrawing the sheath releases the anchor that engages the proximal section of the implant relative to the proximal wall of the second lumen. In some embodiments, the distal section of the implant is held within the nose cone in a radially compressed configuration, while the proximal section of the implant is in a radially expanded configuration. In some embodiments, the method further comprises advancing the nose cone relative to the distal section of the implant, thereby transitioning the distal section of the implant to a radially expanded configuration. In some embodiments, advancing the nose cone releases an anchor that engages the proximal section of the implant relative to the proximal wall of the second lumen.

In some embodiments, disclosed herein is an intraluminal delivery system or device comprising: a nose cone comprising a proximal tapered end, a central lumen, a distal tapered end, and a longitudinal axis; and a flexible sheath comprising a longitudinal axis, wherein the device is configured such that the distal end of the flexible sheath is configured to be positioned within the central lumen of the burr such that when the flexible sheath enters the central lumen of the burr at the proximal tapered end of the burr when the longitudinal axis of the flexible sheath is not coaxial with the longitudinal axis of the burr, a gap is formed between the proximal tapered end of the burr and the sidewall of the flexible sheath.

One or more of the following features may also be provided in the systems or devices described above or in other embodiments described herein. In some embodiments, the nose cone includes a slit. In some embodiments, the slit is located 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.

In some embodiments, disclosed herein is an endoluminal 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 including a flow lumen therethrough, wherein the at least one axially oriented connecting strut serves as the sole connection between the proximal implant segment and the distal implant segment, wherein the axial length of the proximal implant segment is longer than the axial length of the distal implant segment, wherein the implant comprises a shape memory material.

In the above implants or other embodiments described herein, one or more of the following features may also be provided. In some embodiments, the implant is configured such that the distal implant section contains a diameter that is different from the diameter of the proximal implant section when the implant is in the unstressed state. In some embodiments, the implant is configured such that the diameter of the distal implant section is smaller than the diameter of the proximal implant section when the implant is in the unstressed state. In some embodiments, the implant is configured such that the distal implant section contains a different boundary than the boundary of the proximal implant section when the implant is in the unstressed state. In some embodiments, the implant is configured such that the distal implant section contains a boundary that is smaller than a boundary of the proximal implant section when the implant is in a non-stressed state. In some embodiments, the implant is configured such that when the implant is in a non-stressed state, the distal implant section contains a cross-sectional area that is different from the cross-sectional area of the proximal implant section. In some embodiments, the implant is configured such that when the implant is in a non-stressed state, the cross-sectional area of the distal implant section is smaller than the cross-sectional area of the proximal implant section. In some embodiments, the implant is configured such that the proximal implant section contains a variable diameter and/or cross-sectional area when the implant is in a non-stressed state. In some embodiments, the implant is configured such that the distal edge of the proximal implant segment comprises a continuous strut and/or ring. In some embodiments, the implant is configured such that the distal edge of the proximal implant section comprises a continuous strut and/or loop with one or more anchors. In some embodiments, the implant is configured such that the proximal implant section includes struts of uniform length. In some embodiments, the implant is configured such that the proximal implant segment includes struts of variable length and/or variable width. In some embodiments, the implant is configured such that the proximal implant section includes struts having a length that is different than the strut length of the distal implant section. In some embodiments, the implant is configured such that the distal implant section is longitudinally offset from the proximal implant section when the implant is in the unstressed state. In some embodiments, the proximal implant segment comprises a biocompatible graft material. In some embodiments, the distal implant segment comprises a biocompatible graft material. In some embodiments, the implant comprises a porous or non-porous laminate layer. In some embodiments, the implant comprises a coating comprising heparin and/or a therapeutic agent.

In some embodiments, disclosed herein is an endoluminal implant for creating an arteriovenous fistula, comprising: a proximal implant segment and a distal implant segment comprising proximal and distal ends; the proximal implant section is configured to extend through a ramus vein and a deep vein, a proximal end of the proximal implant section configured to be positioned within the ramus vein; the distal implant segment is connected to the proximal implant segment and configured to be positioned within an artery adjacent to the deep vein, wherein a 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 section is configured to pass flow from the artery into a shallow vein connected to the branch vein.

In the above implants or other embodiments described herein, one or more of the following features may also be provided. In some embodiments, the proximal implant section and the distal implant section comprise expandable tubular bodies. In some embodiments, the endoluminal implant comprises a side opening between the distal end of the proximal implant section and the proximal end of the distal implant section such that blood flowing through the artery enters the side opening and (i) flows through the proximal end of the distal implant section and out the distal end of the distal implant section to continue flowing through the artery, and (ii) flows through the distal end of the proximal implant section and out the proximal end of the proximal implant section to flow into the through-branch vein and into the superficial vein. In some embodiments, the proximal implant segment is at an angle between about 0 to about 90 degrees relative to the axis of the distal implant segment.

In some embodiments, disclosed herein is an endoluminal implant for creating an arteriovenous fistula, comprising: a venous implant section and an arterial implant section; the venous implant section includes 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 be collapsed for delivery into a patient and expandable to radially engage an inner wall of a vein; the arterial implant segment includes 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 be collapsed for delivery into a patient and expandable to radially engage an inner wall of an artery located adjacent a vein; wherein the second end of the venous implant section is connected to the first end of the arterial implant section to allow the arterial implant section to be angled relative to the venous implant section when the venous implant section and the arterial implant section are in an expanded configuration, and wherein the angulation of the arterial implant section relative to the venous implant section increases a distance between the second end of the venous implant section and the first end of the arterial implant section along a side of the implant to provide a side opening into the implant; and wherein when the vein implant segment radially engages the inner wall of the vein and the artery implant segment radially engages the inner wall of the artery adjacent the vein, blood flowing through the artery enters the side opening and (i) flows through the first end of the artery implant segment and out the second end of the artery implant segment, and (ii) flows through the second end of the vein implant and out the first end of the vein implant segment.

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

In the above-described apparatus or in other embodiments 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 proximal wall of the artery after the nose cone is advanced into the artery. In some embodiments, after intra-arterial release of the distal section of the implant, the distal end of the outer sheath may be advanced through the distal section of the implant and into the cavity. In some embodiments, after intra-arterial release of the distal section of the implant to engage the proximal end of the nose cone, the distal end of the outer sheath may be advanced through the distal section of the implant such that the nose cone enters the distal end of the outer sheath. In some embodiments, the delivery device further comprises a guidewire shaft configured to be advanced over the guidewire, wherein the nose cone is secured to the guidewire shaft. In some embodiments, the delivery device further comprises a control knob coupled to the proximal end of the sheath, the control knob configured to retract and/or advance the sheath when the control knob is moved proximally and/or distally, the control knob disposed at least partially within the handle of the delivery device. In some embodiments, the control knob is configured to be releasably locked in a proximal-most and/or distal-most position within the handle. In some embodiments, the delivery device further comprises an intermediate shaft within the outer sheath configured to prevent proximal sliding of the implant during retraction of the outer sheath. In some embodiments, the distal end of the intermediate shaft guides the distal end of the outer sheath as the outer sheath is advanced into the cavity. In some embodiments, the delivery device further comprises an intermediate shaft connector disposed within the handle and connected to a proximal end of the intermediate shaft, the intermediate shaft connector configured to engage the control knob and advance the intermediate shaft with the outer sheath as the outer sheath is advanced into the cavity. In some embodiments, the implant is constrained within the distal end of the outer sheath.

In some embodiments, disclosed herein is a method of creating an arteriovenous fistula between an artery and a vein of a patient, comprising: delivering a collapsed endoluminal implant into a patient, the endoluminal implant comprising a venous implant section comprising a first tubular body and an arterial implant section comprising a second tubular body, wherein the venous implant section is connected to the arterial implant section; extending the endoluminal implant through any interstitial spaces 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 vein and arterial implant segments are radially engaged with the vein and the artery, respectively, the arterial implant segments are angled relative to the vein implant segments to provide a side opening into the endoluminal implant that allows blood flowing through the artery to enter the side opening and (i) flow through the second tubular body of the arterial implant segments to continue flowing through the artery and (ii) flow through the first tubular body of the vein implant segments to flow into the vein.

In some embodiments, disclosed herein is a method, system, or apparatus comprising, consisting essentially of, consisting of, and/or excluding any number of features of the present disclosure.

Drawings

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

fig. 1 illustrates a simplified representation of a portion of human arm vasculature indicating potential areas for creating an anastomotic connection, according to some embodiments.

Figures 2A-2D illustrate a method of percutaneously introducing an intravascular guide wire according to some embodiments.

Figures 3-15 illustrate a method of percutaneously implanting an endovascular implant according to some embodiments.

Fig. 16A-16C illustrate an endovascular implant according to some embodiments.

Figures 17A-17I illustrate an endovascular implant according to some embodiments.

Fig. 18A-18B illustrate an endovascular implant according to some embodiments.

Fig. 19 illustrates a partial cross-sectional view of various elements of a delivery system according to some embodiments.

Fig. 20 illustrates perspective and cross-sectional views of a nose cone of a delivery system according to some embodiments.

Fig. 21A illustrates a perspective view of a handle of a delivery system according to some embodiments.

Fig. 21B illustrates a cross-sectional view of a handle of a delivery system according to some embodiments.

Fig. 22A illustrates a perspective view of a delivery system according to some embodiments.

Fig. 22B illustrates a cross-sectional perspective view of a delivery system according to some embodiments.

Fig. 22C illustrates an exploded perspective view of a delivery system according to some embodiments.

Fig. 22D illustrates a cross-sectional view of the distal end of a delivery system according to some embodiments.

Fig. 22E illustrates a perspective view of a delivery system according to some embodiments, with a portion of a handle housing of the delivery system removed from view.

Fig. 23 illustrates a simplified representation of a portion of a human vasculature indicating potential areas for creating an anastomotic connection, according to some embodiments.

Fig. 24-27 illustrate methods of percutaneously introducing an intravascular guide wire according to some embodiments.

Fig. 28-38 illustrate methods of percutaneously implanting an endovascular implant according to some embodiments.

Fig. 39 illustrates a method of bypassing a portion of an artery with an endovascular implant, according to some embodiments.

Throughout the drawings, reference numerals may be repeated to indicate general correspondence between reference elements unless otherwise indicated. The drawings are provided to illustrate the exemplary embodiments described herein and are not intended to limit the scope of the disclosure.

Detailed Description

Embodiments disclosed herein relate generally to medical devices and methods. More particularly, some embodiments relate to intravascular implants and methods and devices for efficiently and accurately placing them in the vasculature. 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 anastomosis devices for creating arteriovenous fistulae (AVFs), while minimizing or eliminating the need for radiological imaging, thus allowing their use in clinical environments using only non-invasive imaging techniques (e.g., percutaneous ultrasound). Some embodiments utilize novel means for temporarily engaging the anatomy while delivering the endovascular implant. Furthermore, 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 of producing AVFs, including bypassing deep venous branches that may undesirably deviate arterial blood flow from a desired shallow vein, as well as preventing or reducing auxiliary procedures such as ligation and embolization.

Fig. 1 shows a simplified representation of a portion of the vasculature of a human arm having a skin surface (e.g., dermal surface 28). Position 7 is a potential area for creating an anastomotic connection between a first lumen and a second lumen (e.g., an artery and vein, such as AVF between deep vein 3 and adjacent deep artery 4). The puncture vein 2 connects the superficial vein 1 to the deep vein 3, the deep vein 3 being located near the access location 7 and providing a conduit for the access location 7. AVF can be created between the puncture vein 2 and the artery 4, bypassing the deep vein 3. In some embodiments, the AVF between the perforator vein 2 and the artery 4 may transfer blood from the artery into the superficial vein 1 connected to the perforator vein 2.

Figures 2A, 2B, 2C and 2D illustrate some embodiments of a method of percutaneously introducing an intravascular guide wire 5 into a deep artery 4 using a needle access tool 35. The needle access tool 35 may comprise a hollow needle having a proximal port 30 and a distal sharp tip 34 slidably disposed within a sheath 33. Sheath 33 is connected to hub 32, and hub 32 has a compression element, such as compression spring 31, disposed between port 30 and hub 32. When the port 30 is depressed, the needle tip 34 is exposed distally of the distal end of the sheath 33 and is capable of penetrating tissue such as skin and blood vessels. When port 30 is not depressed, spring 31 will decompress and move needle tip 34 proximally so that needle tip 34 is not exposed. In this configuration, the needle access device may navigate through the vasculature while reducing the risk of accidental puncture and trauma to the vasculature. Using this feature of the needle access tool 35 and a suitable imaging technique, such as percutaneous ultrasound, the needle access tool is first introduced into the superficial vein 1, as shown in fig. 2A. With the needle tip 34 retracted within the sheath 33, the needle entry tool is navigated to position 7 using appropriate imaging, as shown in fig. 2B. When in position 7, proximal port 30 is actuated (e.g., depressed) to expose needle tip 34, and then needle access tool 35 is advanced to penetrate the vessel wall and any interstitial tissue between deep vein 3 and deep artery 4 until the distal end of sheath 33 enters the lumen of deep artery 4. While maintaining this position, the guidewire 5 is introduced into the proximal port 30 and advanced through the needle access tool 35 until the distal end of the guidewire 5 exits the distal end of the needle access tool 35 and enters the lumen of the deep artery 4, as shown in fig. 2C. Fig. 2D shows a guidewire 5 having a bend 6, the bend 6 being formed when the guidewire 5 conforms to a particular vascular anatomy. The needle access tool 35 may have alternative embodiments that may include a curved distal end to allow easier navigation through the vasculature, a hemostatic valve attached to the proximal port 30, and a spring-loaded hollow needle that may help puncture the movable structure. Alternative locations to location 7 may also be selected to create AVFs. For example, if the distance between the deep vein 3 and the deep artery 4 is smaller than the distance at location 7, a location further along the deep vein 3 may prove to be more advantageous. Some embodiments are not limited to connections between deep veins and deep arteries, such as in the upper or lower extremities, such as in the hands, forearm, arm, foot, calf, thigh, or other areas. Some embodiments may be used to accurately position implants in other luminal structures such as superficial veins and arteries, coronary arteries, female physiological structures (e.g., vagina, cervix, uterus, or fallopian tubes), urinary system structures (e.g., ureters, bladder, or urethra), and gastrointestinal structures (e.g., esophagus, stomach, small intestine, large intestine, rectum, biliary tract, and others).

Fig. 3 shows the distal end of an intravascular delivery system 29 having a distal nose cone 8, the distal nose cone 8 having a distal taper 10, a cavity 9 (e.g., a central lumen), and a tapered proximal end 11, the tapered proximal end 11 being introduced into the vasculature and approaching AVF location 7 over a guidewire 5 having a bend 6. The outer sheath 12 is shown restraining the implant 13 in a low profile configuration, wherein the distal end of the outer sheath 12 is inserted into the cavity 9. The delivery system 29 is shown with a curvature that conforms to the shape of the guidewire 5 and the vascular anatomy. The delivery system 29 may be flexible or relatively rigid in comparison to the surrounding vascular structure and 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 end of the distal taper 10 may 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, the nose cone 8 is bonded or otherwise secured to the inner guidewire shaft 22 as shown in fig. 8, but not shown in fig. 3.

Fig. 4 shows the nose cone 8 of the delivery system 29 advanced through the AVF site 7 and within the deep artery 4. Intermediate shaft 16 is shown slidably disposed within outer sheath 12. The intermediate shaft 16 is slidably arranged around a guide wire shaft 22, which is not shown in fig. 4. Also shown is the gap 14 that may be formed when the delivery system 29 is along the guidewire bend 6 and the nose cone 8 and outer sheath 12 are no longer coaxial. In some embodiments, when the gap 14 enters the proximal opening of the nose cone 8, the gap 14 may be defined as an open space between the proximal opening of the nose cone 8 and the sidewall of the outer sheath 12. In some embodiments, the gap defines a length and/or diameter of the proximal opening of the nose cone 8 that is 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 corresponding length and/or diameter, or a range including any two of the foregoing values. 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.

When the distal end of the delivery system 29 is in a curved configuration with the proximal end of the tapered proximal end 11 located outside of the curve as shown in fig. 4, an angle 15 may be formed between the central (e.g., longitudinal) axis of the nose cone 8 and the central (e.g., longitudinal) axis of the outer sheath 12. In some embodiments, the angle 15 may be, for example, about, at least about, or no more than about 5, 10, 15, 20, 25, 30, 35, 40, 45 degrees, or more or less, and include a range of any two of the foregoing values. To facilitate greater flexibility between the nose cone 8 and the outer sheath 12, the nose cone 8 may have a slit in the wall forming the cavity 9. In some embodiments, the bend of the guidewire 5 may be used to form an angle 15, thereby forming a gap 14. Alternative methods of forming the angle 15 and the gap 14 may be used. An alternative embodiment may be, for example, to use one, two or more wires to deflect the distal end of delivery system 29, thereby forming gap 14. Depending on the clinical outcome desired, a variety of steerable and/or deflectable elements may be used. In some cases, the gap 14 may 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.

Fig. 5 shows the nose cone 8 engaging the proximal wall of the deep artery 4 after the delivery system 29 has been pulled proximally from its position in fig. 4. The engagement between the nose cone 8 and the proximal wall of the deep artery 4 may be due to the gap 14, which may be formed when the delivery system 29 is pushed into a curved configuration with the proximal end of the tapered proximal end 11 on the outside of the curve. In some embodiments, the nose cone 8 may engage the proximal wall of the artery without the need for the gap 14. For example, the proximal end of the tapered proximal end 11 may engage the proximal wall of the artery 4 without a gap 14 between the tapered proximal end 11 and the outer sheath 12. Also shown is the deformation of the anatomy at AVF position 7 as a result of the adhesion between the proximal wall of the deep artery 4 and the tapered proximal end 11 of the nose cone 8. This deformation of the anatomy at AVF position 7 can be visualized by ultrasound and used to verify proper tissue engagement and/or implant placement prior to delivery.

Fig. 6A illustrates an initial step of a first stage of delivery of the elastically constraining implant 13, in accordance with some embodiments. When the nose cone 8 is held against the proximal wall of the deep artery 4, the outer sheath 12 is retracted proximally such that the elastically constraining implant 13 is allowed to expand to the 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 constraining implant 13 does not slide proximally during retraction of the outer sheath 12. Also shown is a distal implant segment 18 partially constrained and retained by the cavity 9. For example, the connecting struts 20, which may be axially oriented as shown, connect the distal implant segment 18 to the proximal implant segment 19, which proximal implant segment 19 has not been fully released in fig. 6A. One or more proximal anchors 17 are also partially confined in the cavity 9. In fig. 6A, radial expansion at AVF position 7 due to the radial stiffness of the elastically expanding implant 13 is shown. The distal end of the proximal implant section 19 may be angled relative to the axis of the distal implant section 18 of the implant such that it does not occlude the deep artery 4 while still being entirely within and supporting the region between the deep vein 3 and the vessel wall of the deep artery 4. In some embodiments, the distal end of the proximal implant segment 19 may be at an angle between about 0 degrees and about 90 degrees relative to the axis of the distal implant segment 18. In some embodiments, as shown in fig. 6B, proximal retraction of the outer sheath 12 may release one or more proximal anchors 17. The proximal anchor 17 may engage the proximal wall of the deep artery 4 (as shown in fig. 6B), the wall of the deep vein 3, the wall of the through-branch vein 2, the wall of the shallow vein 1, and/or any interstitial tissue.

Fig. 7A, next to fig. 6A, shows continued delivery of the elastically constraining implant 13 as the sheath 12 is further retracted until the proximal implant section 19 is fully released from the sheath 12. Fig. 7B, next to fig. 6B, shows continued delivery of the elastically constraining implant 13 as the sheath 12 is further retracted until the proximal implant section 19 is fully released from the sheath 12.

Fig. 8 illustrates delivery of the distal implant section 18 of the implant 13, and in some embodiments release of the proximal anchor 17. When the nose cone 8 is advanced distally by advancing the guidewire shaft 22 distally, the distal implant segment 18 is held in its axial position by the connecting strut 20 and is thus slidably released from the cavity 9. In some embodiments, proximal anchors 17, which may be shaped, for example, as a hooked configuration, may also be resiliently released from cavity 9 as nose cone 8 advances and assume their hooked shape to secure the proximal-most portion of the distal edge of proximal implant segment 19 to the proximal wall of deep artery 4. In some embodiments, the proximal anchor 17 may be released as the sheath 12 is retracted proximally and as the nose cone 8 is advanced distally. In an alternative embodiment, there is no proximal anchor 17, as the attachment between the struts of the implant 13 and the surrounding anatomy provides adequate anchoring. In the illustrated embodiment, the distal implant section 18 provides a means of securing the distal-most portion of the distal edge of the proximal implant section 19 so that it does not invade the luminal space of the deep artery 4. The distal implant section 18 may also provide radial support to the deep artery 4 to ensure patency and adequate distal blood flow after implantation of the implant 13. The distal implant segment 18 may be sized to be received by the deep artery 4. In some embodiments, the distal implant section 18 is 0-50% larger in diameter than the deep artery 4. In other embodiments, the distal implant segment 18 is 5-25% larger in diameter than the deep artery 4. In some embodiments, the proximal implant section 19 is between about 2mm to about 7mm in diameter. In some embodiments, the distal implant segment 18 is between about 2mm to about 7mm in diameter. In some embodiments, the proximal implant section 19 and the distal implant section 18 may have substantially the same diameter. In some embodiments, the proximal implant section 19 and the distal implant section 18 may have different diameters. In some embodiments, the proximal implant section 19 is about 5mm in diameter and the distal implant section 18 is about 4 millimeters in diameter. In some embodiments, the cross-sectional shape of the proximal implant section 19 and/or the distal implant section 18 may not be circular, so they may alternatively have the same or different cross-sectional areas and/or circumferences. In some embodiments, there is no portion of distal implant section 18 of implant 13. In some embodiments, there is no distal implant segment 18 portion of implant 13, and the distal end of proximal implant segment 19 may include a continuous strut and/or ring, which may also be referred to as an anastomotic ring. 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 strut and/or ring with a skirt and/or flange that extends into the deep artery 4 and seals against the proximal wall of the deep artery 4 when deployed.

Fig. 9 illustrates an initial step of removing the delivery system 29 according to some embodiments, wherein the outer sheath 12 and intermediate shaft 16 are advanced distally through the delivered implant 13 and into the cavity 9. In some embodiments, the intermediate shaft 16 guides the outer sheath 12 during this advancement step to facilitate secure engagement of the outer sheath 12 into the cavity 9 without the outer sheath 12 seizing up on the proximal end 11 of the distal nose cone 8.

Fig. 10A shows a subsequent process of removal of delivery system 29, wherein delivery system 29 is rotated about its axis, for example about 180 degrees, such that the proximal portion of tapered proximal end 11 of nose cone 8 is on the inside of bend 6. In this orientation, the gap 14 is minimized, eliminated or substantially eliminated, and there is 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 engagement of any anatomical features near the delivered implant 13 or AVF site 7.

Fig. 10B shows an alternative embodiment for providing a low profile removal configuration for delivery system 29. In this embodiment, nose cone 8 is rotated about its axis, for example, about 180 degrees, before advancing sheath 12 through implant 13. After rotation of the nose cone 8, 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 configuration of the tapered proximal end 11, the outer sheath 12 may enter the inner diameter of the outer sheath 12 as it is advanced. In this configuration, there is no structure on the delivery system 29 that could interfere with its removal from the body. For complete removal in this embodiment, the delivery system is retracted while maintaining the overlap of the outer sheath 12 over the nose cone 8 until it exits the body.

Fig. 11 shows a subsequent process of removal of delivery system 29 in the configuration depicted in fig. 10A. The tapered proximal end has entered the delivered distal implant section 18 without interference due to the low profile configuration. A preferred embodiment is one in which implant 13 has an unconstrained delivery internal dimension that is greater than the external dimension of nose cone 8 so that nose cone 8 does not experience excessive drag or interference with implant 13 when removed through implant 13.

Fig. 12 shows a further subsequent process of removal of the delivery system 29. Delivery system 29 has been retracted further and nose cone 8 has traveled partway through proximal implant section 19 of implant 13.

Fig. 13 shows a subsequent process of removal of delivery system 29. Delivery system 29 has been fully retracted and passed through implant 13. Due to the curvature of the anatomy at this location, the gap 14 may be formed again. If gap 14 causes undue resistance to continued removal of delivery system 29 from the body, delivery system 29 may be rotated again to minimize and/or eliminate gap 14 and allow minimal resistance to removal of delivery system 29.

Fig. 14 shows an initial procedure for removal of the guidewire 5 from the body. Before removal of the guidewire 5, it may be desirable or advantageous to advance a balloon dilation catheter sized for the implant 13 and vasculature to facilitate full dilation of the implant 13. In some embodiments of proximal implant section 19 and distal implant section 18 having different diameters, cross-sectional areas, and/or circumferences, different sized balloon dilation catheters may be used to facilitate full expansion of proximal implant section 19 and distal implant section 18.

Fig. 15 shows the complete delivery of the implant 13, with the distal implant section 18 in the deep artery 4 and the proximal section 19 forming an AVF between the deep vein 3 and the deep artery 4. In this embodiment, implant 13 is anchored in place at least in part with proximal anchor 17 and distal implant 18. Alternative anchoring features such as barbs may also be used in some embodiments. In a preferred embodiment, the implant 13 is covered or encapsulated by a biocompatible graft material, such as ePTFE, which may promote intravascular healing while minimizing luminal narrowing due to proliferation. In some embodiments, the graft material envelope may be constructed with a laminate of an inner layer of porous graft material (e.g., ePTFE) covering the inner surface of the implant 13 and an outer layer of porous graft material (e.g., ePTFE) covering the outer surface of the implant 13 that have been bonded together. In some embodiments, the bonding of the inner and outer layers of porous graft material encapsulates the struts of implant 13, and may be accomplished by fusing the outer and inner layers together by heating and compression. In other embodiments, a laminate layer of thermoplastic material, such as Fluorinated Ethylene Propylene (FEP) film, polyethylene (PE), or thermoplastic polyurethane film (TPU), may be disposed between the inner and outer layers of porous graft material to facilitate bonding. In some embodiments, the thermoplastic laminate layer may be porous, while in other embodiments, the laminate layer may be non-porous. In some embodiments, the porosity of the encapsulated implant 13 may be maintained by wrapping strips of non-porous thermoplastic laminate layer in a spiral fashion between the inner and outer layers of porous graft material with a gap between each wrap of thermoplastic laminate layer. In some embodiments, no gap is left between each wrap of thermoplastic laminate layer, such that the final assembly is non-porous, but has a porous surface. Covering or enveloping the proximal implant section 19 with the graft material may prevent blood from penetrating into the interstitial tissue or any interstitial tissue between the deep vein 3 and the deep artery 4, which may lead to hematomas, infections, and other complications. Covering the proximal implant section 19 with graft material may also assist in transferring blood flow from the deep artery 4 into the shallow vein 1.

Fig. 16A, 16B and 16C illustrate an embodiment of implant 13. Fig. 16A shows a diagram of features for cutting from a superelastic tube (e.g., a superelastic NiTi tube) to form implant 13. A cross section of a cutting pattern forming the proximal implant segment 19, the distal implant segment 18, the proximal anchor 17 and the connecting struts 20 is shown. In some embodiments, the implant 13 may alternatively be made of super-elastic wire or formed of roll-cut super-elastic sheet material. Fig. 16B shows the shape of implant 13 after the pattern of fig. 16A has been cut from the tube. Fig. 16C shows the implant 13 with the distal implant section 18, the proximal implant section 19 and the connecting struts 20 after the implant 13 has been shape set from a superelastic tube (e.g., superelastic NiTi tube) using well known techniques. Also shown in fig. 16C is a graft material covering the inner diameter of proximal section 19. The graft material may be used to cover the inner and/or outer diameter of any portion of the implant 13 (e.g., its entirety or less than its entirety), depending on the particular needs of the application. Expanded polytetrafluoroethylene, also known as ePTFE, has proven to be an advantageous graft covering for intravascular implants. Other materials such as polyester webs may also be suitable for certain embodiments. The implant 13 may be covered or encapsulated with a biocompatible implant material as described elsewhere herein. In some embodiments, the proximal implant segment 19 may include an elongate tubular member or body having a proximal end, a distal end, and a flow path therethrough. In some embodiments, the distal implant segment 18 may include an elongate tubular member or body having a proximal end, a distal end, and a flow path therethrough. In some embodiments, the distal implant segment 18 may be positioned downstream of the location of the distal end of the proximal implant segment 19 (e.g., downstream with respect to the direction of arterial blood flow). In some embodiments, the implant 13 may not have proximal, distal, and/or anchoring features, and may have a more basic configuration that requires only precise placement within the body. In some embodiments, the anchoring features of implant 13, such as proximal anchors 17, may form an angle between about 10 degrees and about 90 degrees with respect to the body of implant 13. In some embodiments, the anchoring features of implant 13, such as proximal anchors 17, may form an angle between about 35 degrees and about 40 degrees with respect to the body of implant 13. Implant 13 may also be made of a bioresorbable material, such as PLA, PGA, PLLA or other suitable material for a particular application. Implant 13 may also be coated with heparin and/or therapeutic agents, including drugs and compounds known to reduce intimal hyperplasia and/or vascular stenosis in endovascular implant applications, on its inner surface, outer surface/outer surface, or both. In some embodiments, the implant 13 according to fig. 16A-16C may be only partially covered or encapsulated with a biocompatible graft material, including a laminate layer and/or a coating, e.g., only the proximal implant section 19 may be covered/encapsulated with a biocompatible graft material, have a laminate layer, and be coated.

Fig. 17A-17I illustrate an embodiment of implant 13. Fig. 17A illustrates a pattern of features for cutting from a superelastic tube (e.g., a superelastic NiTi tube) to form implant 13. A cross section of a cutting pattern is shown forming a proximal implant segment 19, a distal implant segment 18 and a connecting strut 20 connecting the proximal implant segment 19 to the distal implant segment 18. In some embodiments, implant 13 includes proximal anchors 17, as further shown in the cutting pattern. In some embodiments, the proximal implant segment 19 may include an elongate tubular member or body having a proximal end, a distal end, and a flow path therethrough. In some embodiments, the distal implant segment 18 may include an elongate tubular member or body having a proximal end, a distal end, and a flow path therethrough. In some embodiments, the distal implant segment 18 may be positioned downstream of the location of the distal end of the proximal implant segment 19 (e.g., downstream with respect to the direction of arterial blood flow). In some embodiments, implant 13 includes a continuous strut/ring 21 (also referred to as an anastomotic ring) at the distal edge of proximal implant segment 19, as additionally shown in the cutting pattern (e.g., at the distal edge of the distal end of proximal implant segment 19). As shown in fig. 17A, the continuous strut/ring 21 may include strut elements 21A, 21B, 21C, 21D, 21E, 21F and 21A ', wherein the strut elements 21A and 21A ' are continuous with each other (i.e., they are shown separated in fig. 17A because it is a cut pattern; when cut into tubes, the strut elements 21A and 21A ' are continuous with each other). In some embodiments, the continuous struts/loops 21 may provide a continuous distal edge for the proximal implant section 19 to reduce wrinkles in the encapsulating graft material. In some embodiments, the continuous struts/loops 21 may provide a continuous distal edge to the proximal implant section 19 to improve the sealing of the implant 13 at the inner wall of the deep artery 4. In some embodiments, the continuous struts/rings 21 may 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., increased radial stiffness may result in increased fistula radial expansion). In some embodiments, the proximal implant segment 19 may include struts of different lengths, and additionally illustrates portions of the cutting pattern that form struts 36 of shorter length and struts 37 of longer length. In some embodiments, the struts 37 may have a greater thickness/width than the struts 36, in addition to being longer. In some embodiments, the location of the longer and/or thicker/wider struts 37 may allow for a larger diameter and/or cross-sectional area of the implant 13 relative to the diameter and/or cross-sectional area of the implant 13 in which the struts 36 are located. In some embodiments, the location of the 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 in which the struts 36 are located. In some cases, thinner struts may be used to reduce the radial stiffness of the implant location. Sometimes, longer struts may reduce the radial stiffness of the implant at the location. In some embodiments, the distal and/or proximal ends of the proximal and/or distal implant segments may include a reduced radial stiffness (e.g., to reduce mechanical stress concentrations at the vessel/implant interface) as compared to a radial stiffness along an axial length thereof. In some embodiments, the implant 13 may alternatively be made of super-elastic wire or formed of roll-cut super-elastic sheet material. Fig. 17B shows a perspective view, fig. 17C shows a side view, fig. 17D shows a top view, and fig. 17E shows a bottom view of the implant 13, after the implant 13 has been cut in a superelastic tube, such as a NiTi tube, in the view and shape setting according to fig. 17A, with distal implant section 18, proximal implant section 19, connecting struts 20, proximal anchors 17, continuous struts/loops 21, shorter struts 36, and longer struts 37. Fig. 17F shows a front (distal) view, fig. 17G shows a rear (proximal) view, fig. 17H shows a front (distal) view through the longitudinal axis of the distal implant section 18, and fig. 17I shows a rear (proximal) view through the longitudinal axis of the proximal implant section 19 of the implant 13, wherein the implant 13 has the various features identified in fig. 17A-17E after being cut in a superelastic tube, such as a NiTi tube, from the view and shape setting of fig. 17A. Although not shown in fig. 17A-17I, the implant 13 of fig. 17A-17I may include any one or more of the features described with respect to the implant 13 described herein (including the implants of fig. 8, 15, and 16A-16C), such as being covered or encapsulated with a biocompatible graft material, having a laminate layer, and being coated with heparin and/or other therapeutic agents. In some embodiments, the implant 13 according to fig. 17A-17I may be only partially covered or encapsulated with a biocompatible graft material, including a laminate layer and/or a coating, e.g., only the proximal implant section 19 may be covered/encapsulated with a biocompatible graft material, have a laminate layer, and be coated.

Fig. 18A-18B illustrate various embodiments of implant 13 after shaping and encapsulation with a biocompatible graft material as described herein. The implant 13 of fig. 18A may correspond to the implant 13 described in fig. 17A-17I and is shown to include a distal implant segment 18, a proximal implant segment 19, a connecting strut 20, a proximal anchor 17, a continuous strut/ring 21, a shorter strut 36, and a longer strut 37. As shown, and in accordance with some embodiments, the portion of the proximal implant segment 19 where the longer strut 37 is located has been formed to have a diameter that is greater than the diameter of the portion of the proximal implant segment 19 where the shorter strut 36 is located. In alternative embodiments, such as shown in fig. 18B, the proximal implant section 19 of the implant 13 may include struts of substantially similar length and have a substantially uniform diameter. Fig. 18B also illustrates various features of implant 13 as described herein, including distal implant segment 18, the aforementioned proximal implant segment 19, connecting struts 20, proximal anchors 17, continuous struts/loops 21.

Fig. 19 shows a partial cross-sectional view of the various elements of one embodiment of delivery system 29. A nose cone 8 having a distal taper 10 and a tapered proximal end 11 is shown attached to a guidewire shaft 22. The guidewire shaft 22 has an inner lumen that accommodates a guidewire 5 (shown elsewhere). Intermediate shaft 16 is slidably disposed over guidewire shaft 22 and slidably disposed within outer sheath 12 and adjacent to the proximal end of constraint implant 13. The proximal end of the intermediate shaft 16 terminates in a position where it can be secured to the proximal handle 23 or allowed to move relative to the handle 23. During delivery of the implant 13, the intermediate shaft 16 prevents movement of the implant 13 relative to the guidewire shaft 22 during retraction of the outer sheath 12. The implant 13 is resiliently constrained within the outer sheath 12. The outer shaft 12 is attached to a control knob 26, the control knob 26 being slidably attached to the handle 23 such that controlled retraction of the outer sheath 12 can be achieved by sliding the control knob 26 proximally. The distal end of the sheath 12 terminates within the cavity 9 of the nose cone 8. At its proximal end, the guidewire shaft 22 is secured to the handle 23 and is connected to the lumen of a tube 25, the tube 25 providing a conduit for the guidewire 5 to pass completely through the delivery system 29. A hemostatic valve may be fitted over the proximal end of tube 25 to prevent flashback of blood when delivery system 29 is inserted into the vasculature. Also shown in fig. 19 is a proximal handle 24 that facilitates manipulation of delivery system 29 and some constrained elements of implant 13, including distal implant segment 18, proximal implant segment 19, and connecting struts 20. The handle nose cone 27 provides a guide path and support for the outer sheath 12 slidably disposed within the handle nose cone 27. Fig. 19 shows a preferred embodiment of the delivery system. An alternative preferred embodiment of the delivery system 29 may include thumbwheel control and pull wire features of the outer sheath 12 to allow the nose cone 8 to actively deflect to create the gap 14 instead of relying on the curvature 6 of the guidewire 5, as shown in fig. 6. The material of construction of the delivery system 29 may be any of the materials well known for catheter construction, such as PEEK, HDPE, peBax, nylon, PTFE, combinations thereof, and the like. The diameter and length of the delivery system 29 should be tailored to the particular application. In one embodiment, for an implant 13 having a diameter between 3 mm and 6 mm, the profile of the nose cone 8 is between 6Fr and 9 Fr. In one embodiment, the distance between the handle 23 and the nose cone 8 is between about 15 cm and about 30 cm. Delivery systems 29 of various lengths and diameters may be used in various embodiments of the invention to meet the needs of a particular application.

Fig. 20 shows a three-dimensional view and a sectional view of the nose cone 8. According to some embodiments, tapered proximal end 11 is shown having a profile that is intended to engage tissue when gap 14 is created (as shown above) and not engage tissue or implant structure when gap 14 is eliminated. In some embodiments, tapered proximal end 11 may engage tissue without gap 14. In some cases, the tapered proximal end 11 may engage tissue when it is oriented substantially outside of the curve (e.g., such as curve 6), and may not engage tissue when it is oriented substantially inside of the curve. The cavity (e.g., central lumen) 9 shown is of sufficient size to accommodate the outer sheath 12 (not shown) and may include a proximal opening. In some embodiments, the proximal opening may be inclined relative to the longitudinal axis of the nose cone 8. To improve the flexibility between the nose cone 8 and the outer sheath 12, slits or slots may be included in the wall forming the cavity 9, preferably in the region of the shorter wall section forming the cavity 9 shown in the cross-sectional view of the nose cone 8. The nose cone 8 includes a cone portion 10, which cone portion 10 facilitates sliding over the guidewire 5 (not shown) and through anatomical structures that have not yet been expanded to a diameter equal to or greater than the outer diameter of the nose cone 8. As shown, in some cases, the cone portion 10 may taper distally. Nose cone 8 may be made of well known materials suitable for catheters, such as PEEK, HDPE, and polypropylene. In some embodiments, nose cone 8 may include an echogenic feature to aid in ultrasound imaging.

Fig. 21A-21B show three-dimensional and cross-sectional views of the handle 23 and its various elements. A handle nose cone 27 is shown attached to the distal end of handle 23, with a tube slidably receiving sheath 12 (not shown). A control knob 26 is slidably restrained within the handle 23 and is used to control the axial position of the sheath 12 (not shown). The tube 25 allows the guidewire 5 (not shown) to pass through the handle 23.

Fig. 22A-22E illustrate another embodiment of a delivery system or device 29. The delivery device may be configured for percutaneous access to the arm of the patient or to another location of the patient. Fig. 22A shows a perspective view, fig. 22B shows a cross-sectional perspective view, and fig. 22C shows an exploded perspective view of a delivery device 29 according to the present and some embodiments. Further, fig. 22D shows a cross-sectional view of the distal end of the delivery device 29, and fig. 22E shows a perspective view of the delivery device 29 with a portion of the handle housing of the delivery device 29 removed from the view. The delivery device 29 shown by fig. 22A-22E may share common elements with the delivery device 29 shown by fig. 19-21B and may function similarly to the delivery device 29 shown by fig. 19-21B; accordingly, common elements may share common reference numbers to indicate a general correspondence between referenced elements.

As shown in fig. 22A-22E, 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 that may be secured together by mechanical fasteners, adhesives, or molded to be snap-fit or press-fit together. As shown in fig. 22A, the handle 23 may include a proximal handle 24 at its proximal end, which may facilitate manipulation of the delivery device 29. As also shown in fig. 22A, the handle 23 may include a nose cone 27 at its distal end with a tube that may provide a guide path and support for the outer sheath 12 slidably disposed within the handle 23 and nose cone 27. Also shown in fig. 22A, a control knob 26 is slidably restrained within a longitudinal opening of the handle 23, a portion of the control knob 26 extending outside of the 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.

According to some embodiments, the perspective cross-sectional view of fig. 22B and the exploded perspective view of fig. 22C show additional details of the delivery device 29 shown in fig. 22A. As shown, the guidewire shaft 22 may traverse the longitudinal length of the handle 23. The guidewire shaft 22 may be fluidly connected at its proximal end to a guidewire shaft connector 55, the guidewire shaft connector 55 being disposed partially within the handle 23 at the proximal end of the handle 23. The guidewire shaft connector 55 may be similar to the tube 25 described herein. The guidewire shaft connector 55 may extend proximally beyond the handle 23 and terminate in a guidewire shaft connector fitting 56, which guidewire shaft connector fitting 56 may be coupled to a valve and/or tube for controlling flashback upon insertion of the delivery device 29 into the vasculature. The guidewire shaft connector 55, when fluidly connected to the guidewire shaft 22, may form a common lumen with the guidewire shaft 22 to allow insertion of a guidewire 5 as described herein into the proximal end of the guidewire shaft connector 55 (e.g., through the guidewire shaft connector fitting 56), through the guidewire shaft connector 55, and then through the guidewire shaft 22 as the guidewire 5 is distally displaced. Also shown, a guidewire shaft housing connector 57 may be disposed distally of the guidewire shaft connector fitting 56 within the handle 23, the guidewire shaft housing connector 57 configured to attach to the guidewire 22 and provide support (e.g., mechanical support) for the guidewire 22. As also shown, the delivery device 29 may also include an intermediate shaft connector 50, with the intermediate shaft connector 50 disposed within the handle 23 and configured to be connected to the proximal end of the intermediate shaft 16. The delivery device 29 may also include an intermediate shaft connector stop 52, which intermediate shaft connector stop 52 may be a feature (e.g., a molded feature) of the handle 23, as shown. Also shown, control knob 26 may include a distal latch 47 and a proximal latch 48 that may interact with features of handle 23, including, in some embodiments, a distal housing latch 53 and a proximal housing latch 54. In addition, the control knob 26 may include a spring element 46 that may also interact with features of the handle 23.

Further connection and operation of the elements of the delivery device 29 according to some embodiments will be discussed next with reference to the cross-sectional view of fig. 22D and the perspective view of fig. 22E (which shows the delivery device 29 with the left housing 44 of the delivery device 29 removed from view). As shown, the guidewire shaft 22 may extend generally longitudinally within the handle 23 and may be connected at its proximal end to a guidewire shaft connector 55 as described above. In addition, the guidewire may extend distally through handle nose cone 27 and terminate distally at the junction with nose cone 8. Thus, in combination with the guidewire connector 55 and the nose cone 8, the guidewire shaft 22 may form a central lumen configured to slidably receive the guidewire 5 as described herein (e.g., the guidewire 5 may slide within the delivery device 29, and/or the delivery device may slide along the guidewire 5).

The intermediate shaft 16 as described herein may be disposed coaxially with the guidewire shaft 22 and may slide along the guidewire shaft 22, and as shown, may have a proximal end that connects with the intermediate shaft connector 50 disposed within the handle 23 and a distal end that may terminate short of the nose cone 8. Thus, the intermediate shaft 16 and intermediate shaft connector 50 may slide together distally/proximally along the guidewire shaft 22. The intermediate shaft connector 50 may have a proximal end configured to abut the intermediate shaft connector stop 52 when in its proximal-most position and a distal end configured to interact with the control knob 26. In some embodiments, the intermediate shaft connector 50 may include an intermediate shaft connector recess 51, the intermediate shaft connector recess 51 configured to engage the control knob 26 when the control knob 26 is slid to its proximal-most position in the handle 23. For example, the intermediate shaft connector recess 51 may frictionally engage the control knob 26 as the control knob 26 is slid proximally and into the recess. As another example, the intermediate shaft connector recess 51 may include a protrusion that helps the intermediate shaft connector 50 to remain on/engaged with the control knob 26 as the control knob 26 slides proximally and passes the protrusion within the recess.

The outer sheath 12 as described herein may be disposed coaxially with the intermediate shaft 16 and may be slidable along the intermediate shaft 16, and as shown may have a proximal end connected to the control knob 26 and a distal end that may terminate within the nose cone 8, partially within or near the nose cone 8. Thus, the outer sheath 12 and the control knob 26 may slide together distally/proximally along the intermediate shaft 16. The control knob 26 may include a spring element 46 as shown, the spring element 46 being 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 longitudinal inner surface) of the handle 23. The control knob 26 may also include features that may interact with the handle 23 and hold the control knob 26 in a desired position distally and/or proximally. For example, the control knob 26 may include a distal latch 47 and a proximal latch 48 (which may each be in the form of stepped edges), respectively, disposed near the distal and proximal ends thereof and proximate to the location where the control knob 26 protrudes through the longitudinal opening of the handle 23, as shown, and the handle 23 may include a distal housing latch 53 and a proximal housing latch 54, the distal housing latch 53 and the proximal housing latch 54 configured to interact with the distal latch 47 and the proximal latch 48, respectively. Further, as shown, the distal housing lock 53 and the proximal housing lock 54 may be disposed near the longitudinally open distal and proximal ends of the handle 23, respectively, and may each include a ramped surface facing the control knob 26 and a stepped edge facing away from the control knob 26. In such an embodiment and further to this example, as the control knob 26 is slid distally to its fully distal position, the control knob 26 may deflect downwardly (e.g., inwardly into the handle 23) upon contact thereof and ride along the ramped surface of the distal housing catch 53 until the stepped edge of the distal catch 47 passes the stepped edge of the distal housing catch 53, at which point the control knob 26 may return to its more upward position within the handle 23 and the interaction between the stepped edges of the distal and distal housing catches 47, 53 control knob 26 remains locked in place. To unlock the control knob 26 from this distal position, the control knob 26 may be pushed inwardly toward the center of the handle 23 (as opposed to the upward force provided by the spring element 46) until the stepped edge of the distal catch 47 disengages from the stepped edge of the distal housing catch 53 (e.g., they no longer overlap longitudinally), and then the control knob 26 may slide proximally. Locking and unlocking of the control knob 26 in its proximal-most position may be similarly performed with the corresponding proximal lock 48 and proximal housing lock 54. In some embodiments, when control knob 26 is slid proximally to its proximal-most position, control knob 26 may engage with intermediate shaft connector recess 51 of intermediate shaft connector 50 such that intermediate shaft connector 50 locks onto control knob 26; subsequent movement/sliding of the control knob 26 may move the intermediate shaft connector 50 and the intermediate shaft 16 to which it is attached, along with the control knob 26 and the outer sheath 12. The intermediate shaft connector stop 52 as described above may assist in the engagement of the intermediate shaft connector 50 with the control knob 26 by preventing the intermediate shaft connector 50 from moving proximally when the control knob 26 moves proximally into the intermediate shaft connector recess 51. In some embodiments, the control knob 26 and the handle 23 may include other features that help lock the control knob 26 in a desired position. In some embodiments, distal lock 47, proximal lock 48, distal housing lock 53, and proximal housing lock 54 may include different features than those described above, but with similar function.

As described herein, and as shown in fig. 22D, the distal end of delivery device 29 may include a nose cone 8, the nose cone 8 including a distal taper 10, a cavity 9, and a tapered proximal end 11. The distal taper 10 may be symmetrical along the longitudinal length of the nose cone 8 and may include a longitudinal through bore; in some embodiments, the guidewire shaft 22 may be attached to the nose cone 8 at a longitudinal through hole. The diameter and/or cross-sectional area of the longitudinal through-hole may be smaller than the diameter and/or cross-sectional area of the cavity 9. The cavity 9 may comprise a diameter and/or cross-sectional area that is larger than the outer diameter of the outer sheath 12. Nose cone 8 may include a proximal end that is angled relative to the longitudinal length of nose cone 8. For example, referring to fig. 22D, nose cone 8 may include a proximal end that is angled at about 30 degrees relative to the longitudinal length of nose cone 8, although other angles may be used. In some embodiments, nose cone 8 may include a proximal end that is angled between about 5 degrees and about 90 degrees relative to the longitudinal length of nose cone 8. In some embodiments, nose cone 8 may include a proximal end that is angled at 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 longitudinal length of nose cone 8. In some embodiments, the angled proximal end of nose cone 8 may allow nose cone 8 to deflect preferentially in one direction over another. For example, the nose cone 8 as shown in fig. 22D may preferably deflect upward (i.e., the distal end of the nose cone 8 may deflect upward) and may not preferably deflect downward due to its angled proximal end. In some embodiments, since the angled proximal end of the nose cone 8 substantially inhibits movement, the distal end of the nose cone 8 may be inhibited from movement in one direction (e.g., the proximal end of the nose cone inhibits movement due to interaction with any of the guidewire shaft 22, the intermediate shaft 16, and/or the outer sheath 12). The proximally facing edge of the proximal end of nose cone 8 may include a taper, such as shown in fig. 20, which may also be referred to as tapered proximal end 11 as described herein. As shown, the tapered proximal end 11 of the nose cone 8 may taper in the proximal direction to a smaller cross-sectional area, i.e., it may include a taper opposite the distal taper 10. The tapered portion of tapered proximal end 11 may facilitate retraction of nose cone 8 as described herein. In some embodiments, the proximal end of nose cone 8 may comprise a circular, oval, oblong, pear-shaped, egg-shaped, or any symmetrical or irregularly shaped cross-sectional shape. In some embodiments, the width of the proximal end of nose cone 8 may be greater than the height of the proximal end of nose cone 8 along the longitudinal axis of nose cone 8. In some embodiments, the size of the cavity 9 may be greater than the outer diameter of the outer sheath 12. In some embodiments, the cavity 9 may have a width greater than its height.

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

The delivery device 29 may be used to transdermally deliver an endoluminal implant 13 as described herein. In some embodiments and as described herein, at least a portion of implant 13 may be disposed within cavity 9 of nose cone 8. In some embodiments, at least a portion of the implant 13 may be disposed within the outer sheath 12. In some embodiments, the intermediate shaft 16 may abut the end of the implant 13 when the implant is disposed within the delivery device 29. In some embodiments, the implant 13 is slidably disposed on the guidewire shaft 22. In some embodiments, the implant may be disposed at least partially within the cavity 9 of the nose cone 8, while also being disposed at least partially within the outer sheath 22. In some embodiments, the implant 13 may be disposed within the delivery device 29 in a radially compressed configuration and packaged as a kit. In some embodiments, the kit may include a delivery device 29 and an implant 13. In some embodiments, the kit may further comprise a needle access tool 35 and/or a guidewire 5. In some embodiments, delivery device 29 may be disposable. In some embodiments, delivery device 29 may be reusable. In some embodiments, any of the components and devices described herein can be sterile or non-sterile.

Next, according to some embodiments, it is described how the delivery device 29 with reference to fig. 22A-22E delivers the implant 13 percutaneously after the guidewire 5 has been placed through the vasculature and adjacent vasculature that is desired to be connected through an AVF, although the description provided is applicable to the delivery devices and methods previously described. In some embodiments, the delivery device 29 may be provided with the implant 13 in a radially compressed configuration, the implant 13 being 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 the intermediate shaft 16 abutting the proximal end thereof. Further, the control knob 26 of the delivery device 29 is provided in its distal-most position relative to the handle 23 of the delivery device 29 (and in some embodiments, may be locked in the distal-most position by the interaction between the distal lock 47 of the control knob 26 and the distal housing lock 53 of the handle 23). After sliding distally over the guidewire 5 until the nose cone 8 is positioned at the desired AVF position within the lumen passing through the vasculature (see fig. 4), the delivery device may be pulled back proximally to engage the nose cone 8 against the proximal wall of the vasculature as described herein (see fig. 5). With the delivery device 29 and its nose cone 8 in this position, the control knob 26 may be moved (e.g., slid) relative to the handle 23 of the delivery device 29 to its proximal-most position to proximally retract the sheath 12 (see fig. 6A-6B). In some embodiments, this may include unlocking the distal lock 47 of the control knob 26 from the distal housing lock 53 of the handle 23 before the control knob 26 may be moved proximally, and may also include locking the control knob 26 in its proximal-most position by interaction between the proximal lock 48 of the control knob 26 and the proximal housing lock 54 of the handle 23. Proximal retraction of the outer sheath 12 may allow at least a portion of the implant 13 to radially expand within the lumen of the adjacent vasculature, as well as allow at least a portion of the implant to expand within the cavity 9 of the nose cone 8. In some embodiments, control knob 26 may engage intermediate shaft connector 50 when moved to its proximal-most position within handle 23 of delivery device 29 and lock intermediate shaft connector 50 to control knob 26. With the control knob 26 held in its proximal-most position, the delivery device 29 may be advanced distally over the guidewire 5 to fully release the implant 13 from the cavity 9 of the head cone 8 and allow for full radial expansion of the implant within the lumen of the vasculature (see fig. 8). The control knob 26 may be moved (e.g., slid) relative to the handle 23 from its proximal-most position to its distal-most position (which may include unlocking the proximal latch 48 from the proximal housing latch 54 and again locking the distal latch 47 to the distal housing latch 54) which may result in both the intermediate shaft 16 and the outer sheath 12 being advanced distally through the radially expanded implant and engaging the nose cone 8 as described herein (see fig. 9). The delivery device 29 may be rotated (e.g., about 180 degrees) to create a smooth transition between the nose cone 8 and the outer sheath 12 (e.g., eliminate any gap 14 described herein, see fig. 10A or 10B) and retracted proximally until it is completely removed from the body (see fig. 11-14).

The material of construction of the delivery device 29 may be any material known for catheter construction, such as PEEK, HDPE, peBax, nylon, PTFE, combinations thereof, and the like. The diameter and length of the delivery device 29 may be adapted to the particular application. In some embodiments, the profile of nose cone 8 may be between 6Fr and 9Fr for implants 13 between 3 mm and 6 mm in diameter. In some embodiments, the distance between handle 23 and nose cone 8 may be between about 15 cm and about 30 cm. Delivery devices 29 of various lengths and diameters may be used in various embodiments to meet the needs of a particular application. The nose cone 8 may be made of materials known to be suitable for catheters, such as PEEK, HDPE and polypropylene. In some embodiments, nose cone 8 may include an echogenic feature to aid in ultrasound imaging.

In some embodiments, the delivery device 29 may include a mesh or other wrap disposed about the implant 13 to retain 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 wires or filaments of the mesh or wrap configured to tear the mesh or wrap, thereby releasing the implant 13. Furthermore, in such embodiments, the delivery device 29 may not require the outer sheath 12 or the intermediate shaft 16.

Returning to the simplified representation of a portion of the vasculature of the human arm shown in fig. 1, location 7, which is a potential area for establishing an anastomotic connection, may be a location of the radial artery adjacent a branch point between the radial vein and the brachial vein adjacent the puncture vein. For example, as shown in fig. 1, artery 4 may comprise a radial artery, deep vein 3 may comprise an brachial and/or radial vein (e.g., vein may be brachial vein on the left side of location 7, vein may be radial vein on the right side of location 7), a ramus vein 2 may comprise a ramus vein, and superficial vein 1 may comprise a head vein. Prior to implantation of implant 13, the blood flow may be as follows and as depicted in FIG. 1: blood flow in the radial artery (e.g., artery 4) may be left to right; the blood flow in the brachial and radial veins (e.g., deep vein 3) may be from right to left; blood flow in a ramus vein (e.g., ramus vein 2) may be from the brachial and/or radial veins, and diagonally upward and to the left to the cephalic vein; the blood flow in the head vein (e.g., superficial vein 1) may be from right to left.

Returning to fig. 2A-2D, in some embodiments, the guidewire 5 may be placed percutaneously through the wall of the cephalic vein (e.g., superficial vein 1), through the ramus vein (e.g., ramus vein 2), through the wall of the brachial or radial vein (e.g., deep vein 3), through interstitial tissue or any interstitial tissue between the brachial or radial vein and the radial artery (e.g., artery 4), through the wall of the radial artery (e.g., artery 4).

Returning to fig. 15, in some embodiments, the implant 13 may be implanted with a distal implant segment 18 (which may also be referred to herein as an arterial implant segment) located within a radial artery (e.g., artery 4) and a proximal segment 19 (which may also be referred to herein as a venous implant segment) extending through an brachial or radial vein (e.g., deep vein 3) and a perforator vein (e.g., perforator vein 2). After such implantation of the implant 13, the blood flow may be as follows and as depicted in fig. 15: blood flow in the radial artery (e.g., artery 4) may pass from left to right and as shown into an entry side opening or port of implant 13 (e.g., a side opening or port between proximal implant section 19 and distal implant section 18), and (i) flow through the proximal end of distal implant section 18 and out the distal end of distal implant section 18 to continue through the artery, and (ii) flow through the distal end of proximal implant section 19 and out the proximal end of proximal implant section 19 to flow into a through-branch vein (e.g., through-branch vein 2) and into a head vein (e.g., superficial vein 1). In some embodiments, with continued reference to fig. 15, after implant 13 is implanted as described above, blood flow through the brachial and/or radial veins (e.g., deep vein 3) may be at least partially occluded or completely occluded by proximal implant stage 19. In some embodiments, the proximal segment 19 that blocks blood flow through the brachial and/or radial vein (e.g., deep vein 3) may advantageously deliver more blood through the head vein (e.g., shallow vein 1) and further enhance development of the head vein for hemodialysis. In some embodiments, the proximal section 19 of the implant 13 may advantageously send blood from the radial artery (e.g., artery 4) directly into a through-branch vein (e.g., through-branch vein 2) and/or a head vein (e.g., superficial vein 1) and around one or more branch points of the arm vein and/or radial vein (e.g., deep vein 3). In some embodiments, with continued reference to fig. 15, after implant 13 is implanted as described above, blood flow through the head vein (e.g., superficial vein 1) may be from right to left, and may include venous blood as well as arterial blood provided by implant 13. Arterial blood may flow through the proximal implant section 19 of the implant 13 due to the pressure differential between the artery 4 and the through-branch vein 2 and/or the superficial vein 1. The flow of arterial blood in the head vein (e.g., the superficial vein 1) due to the implant 13 may advantageously cause the head vein to increase in at least one of its size (e.g., diameter), thickness, and blood flow rate. For example, arterial blood flow in the head vein (e.g., the superficial vein 1) due to the implant 13 may advantageously increase the diameter of the head vein to at least about 4mm, at least about 5mm, or at least about 6mm. In another example, arterial blood flow in the head vein (e.g., superficial vein 1) due to the implant 13 may advantageously be such that the blood flow rate in the head vein (e.g., superficial vein 1) is at least about 400cc/min, at least about 500cc/min, or at least about 600cc/min. In some embodiments, the implant 13 may guide the development of the superficial vein 1 into a single entry point for hemodialysis (e.g., two needles in the same vein, one for outflow and the other for reflux). In some embodiments, the implant 13 may direct the superficial vein 1 to form a diameter of at least about 6mm and a blood flow rate of at least about 600cc/min.

With further reference to fig. 15, the proximal implant segment 19 may be angled relative to the distal implant segment 18, as described herein. In another manner and as described herein, in some embodiments, the axis (e.g., longitudinal axis) of the proximal implant segment 19 may be angled relative to the axis (e.g., longitudinal axis) of the distal implant segment 18. The proximal implant segment may be angled between about 0 and 90 degrees relative to the axis of the distal implant segment. In some embodiments, the proximal implant segment 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 the distal implant segment.

With further reference to fig. 15, and with reference at least to fig. 16C, 17B, 17C, 18A and 18B, and as previously described herein, the implant 13 may include a side opening or port disposed between the proximal implant section 19 and the distal implant section 18. A side opening or port may be provided between the distal end of the proximal implant section 19 and the proximal end of the distal implant section 18. As shown in at least some of the figures mentioned above, the side openings or ports may be formed by continuous struts and/or loops 21 of the proximal implant section 19, connecting struts 20, and struts including the proximal end of the distal implant section 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 with respect to the direction of arterial blood flow, as shown).

Fig. 23 illustrates a simplified representation of a portion of a human vasculature indicating a potential location 7 for creating an anastomotic connection (e.g., AVF) between an artery 70 and a vein 80 located below the dermis surface 28, according to some embodiments.

Fig. 24-27 illustrate a method of percutaneously introducing an intravascular guide wire 5 according to some embodiments. The methods illustrated and described by fig. 24-27 may include steps and/or aspects similar to the methods previously described herein by fig. 2A-2D. As shown in fig. 24-27, the guidewire 5 may be percutaneously introduced through a needle access tool 35 as described herein. The needle access tool 35 may comprise a hollow needle having a proximal port 30 and a distal sharp tip 34 slidably disposed within a sheath 33. Sheath 33 may be connected to hub 32, and hub 32 may include a compression element, such as a compression spring 31, disposed between port 30 and hub 32. When the port 30 is depressed, the needle tip 34 may be exposed distal to the distal end of the sheath 33 and is capable of penetrating tissue such as skin and blood vessels. When port 30 is not depressed, spring 31 may decompress and move needle tip 34 proximally so that it is not exposed. In this configuration, the needle access tool 35 may navigate through the vasculature while reducing the risk of accidental puncture and trauma to the vasculature or other tissue. Using this feature of the needle access tool 35 and appropriate imaging techniques, such as percutaneous ultrasound, the needle access tool 35 may first be introduced into the artery 70, as shown in fig. 24. With the needle tip 34 retracted within the sheath 33, the needle entry tool 35 may be navigated to position 7 using suitable imaging, as shown in fig. 25. When in position 7, proximal port 30 may be actuated (e.g., depressed) to expose needle tip 34, and then needle access tool 35 may be advanced to penetrate the vessel wall and interstitial tissue or any interstitial tissue between artery 70 and vein 80 until the distal end of sheath 33 enters the lumen of vein 80. While maintaining this position, as shown in fig. 26, the guidewire 5 may be introduced into the proximal port 30 and advanced through the needle access tool 35 until the distal end of the guidewire 5 exits the distal end of the needle access tool 35 and enters the lumen of the vein 80. Fig. 27 shows a guidewire 5 with a bend 6, which bend 6 may be formed when the guidewire 5 conforms to a particular vascular anatomy after removal of the needle access tool 35.

Fig. 28-38 illustrate a method of percutaneously implanting an endovascular implant 13 using a delivery device 29 according to some embodiments. Fig. 28 shows delivery device 29 after placement over guidewire 5 and sliding distally along guidewire 5 such that its distal end (e.g., nose cone 8 at the distal end of delivery device 29) passes through skin surface 28, through artery 70, through the gap or any interstitial space between artery 70 and vein 80, and into vein 80 (e.g., into the lumen of vein 80). As shown, implant 13 may be disposed within delivery device 29 in a radially compressed configuration. In some embodiments, proximal implant segment 19 as described herein may be disposed in a radially compressed configuration within the distal end of delivery device 29, and distal implant segment 18 may be disposed in a radially compressed configuration within the distal end of delivery device 29, however, as shown herein and contrary to the implantation methods described by fig. 3-15, distal implant segment 18 may be oriented closer to the distal end of delivery device 29 than proximal implant segment 19 (e.g., implant 13 is oriented in a reverse direction relative thereto, as described by fig. 3-15). Thus, as illustrated in fig. 28-38, the distal implant segment 18 will be referred to as an arterial implant segment 18, while the proximal implant segment 19 will be referred to as a venous implant segment 19; however, when discussing the distal and proximal ends of the implant section, the convention used so far herein will remain. Returning to fig. 28, as shown, the implant 13 may be disposed on the guidewire shaft 22 and radially compressed within the outer sheath 12, with the venous implant section 19 disposed at least partially within the nose cone 8 (e.g., within the cavity 9 of the nose cone 8) and the arterial implant section 18 (i.e., the distal end of the arterial implant section 18 consistent with existing practice) abutting the distal end of the intermediate shaft 16.

Fig. 29 shows the nose cone 8 of the delivery device 29 advanced through the AVF site 7 and within the vein 80. Also shown is a gap 14, which gap 14 may be formed when the delivery device 29 follows the guidewire bend 6 and the nose cone 8 and the outer sheath 12 are no longer coaxial. In some embodiments, when the gap 14 enters a proximal opening of the burr 8 (e.g., the cavity 9), it may be defined as an open space between the proximal opening of the burr 8 (e.g., the proximal opening of the cavity 9 of the burr 8) and the side wall of the sheath 12. 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, or a range comprising any two of the foregoing, of the corresponding length and/or diameter of the proximal opening of nose cone 8 (e.g., cavity 9). Notably, as shown, to form the gap 14, the nose cone 8 may need to be oriented as shown in fig. 29, e.g., with its longer trailing proximal end (in some embodiments, due to the proximal end being angled from the longitudinal length of the nose cone, as shown) oriented outboard of the bend 6. Further shown, when the nose cone 8 at the distal end of the delivery device 29 is in a curved configuration as shown in fig. 29 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 may be formed. In some embodiments, the angle 15 may be, for example, about, at least about, or no more than about 5, 10, 15, 20, 25, 30, 35, 40, 45 degrees, or more or less, and include a range of any two of the foregoing values. To facilitate greater flexibility between the nose cone 8 and the outer sheath 12, the nose cone 8 may have slits 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 may be substantially larger than the outer diameter of the outer sheath 12. In some embodiments, the bend 6 of the guidewire 5 may be used to form the angle 15 and the gap 14. Alternative methods of forming the angle 15 and the gap 14 may be used. An alternative embodiment may be to deflect the distal end of the delivery device 29, for example using one, two or more wires, thereby forming the gap 14. Depending on the desired clinical outcome, a variety of steerable and/or deflectable elements may be used. In some embodiments, the gap 14 may not be formed and/or may not be required.

Fig. 30 illustrates the nose cone 8 engaged with the proximal wall of the vein 80 after the delivery device 29 has been pulled proximally from its position in fig. 29, according to some embodiments. The engagement between the burr 8 (e.g., the proximal end of the burr 8) and the proximal wall of the vein 80 may be due to the gap 14, which gap 14 is formed when the delivery device 29 is pushed into a curved configuration with the tapered proximal end 11 (e.g., the longer trailing proximal end) on the outside of the curve. In some embodiments, the engagement between the burr 8 (e.g., the tapered proximal end 11 of the burr 8) and the proximal wall of the vein 80 does not require the gap 14. For example, the tapered proximal end 11 of the nose cone 8 may engage the proximal wall of the vein 80 when the delivery device 29 is pulled proximally. Also shown is the deformation of the anatomy at AVF position 7 as a result of the adhesion between the proximal wall of vein 80 and the tapered proximal end 11 of nose cone 8. This deformation of the anatomy at AVF position 7 can be visualized by ultrasound and used to verify proper tissue engagement and/or implant placement prior to delivery.

Fig. 31 illustrates an initial step of a first stage of delivery of a radially compressed (e.g., elastically constrained) implant 13, according to some embodiments. When the nose cone 8 is held against the proximal wall of the vein 80, the outer sheath 12 may be retracted proximally so that the radially compressed implant 13 can expand to a precise position defined by the engagement between the nose cone 8 and the proximal wall of the vein 80. During retraction of the outer sheath 12, the distal end of the intermediate shaft 16 may remain fixed so that the radially compressed implant 13 does not slide proximally during retraction of the outer sheath 12. It is also shown that the venous implant section 19 is held at least partially constrained by the cavity 9 of the nose cone 8, which may occur when the outer sheath 12 is retracted (e.g., the outer sheath 12 no longer holds the venous implant section 19 radially compressed, so the venous implant section 19 expands into the cavity 9). In some embodiments, a portion of a venous implant section 19 (e.g., distal, but here toward the proximal end) radially expanded at AVF position 7 due to the radial stiffness of implant 13 is also shown. Also shown is an arterial implant segment 18 that is still radially compressed within the outer sheath 12. To retract the sheath 12, the control knob 26 of the delivery device 29 can be slid proximally from its distal-most position with initial delivery of the implant 13, while the handle 23 of the delivery device 29 remains in place to hold the nose cone 8 against the proximal wall of the vein 80. In some embodiments, the intermediate shaft 16 may remain fixed during retraction of the outer sheath 12 by the intermediate shaft connector 50, the intermediate shaft connector 50 being prevented from moving proximally by its interaction with the intermediate shaft connector stop 52 of the delivery device 29.

Fig. 32 illustrates continued delivery of radially compressed (e.g., elastically constrained) implant 13 while outer sheath 12 is further retracted until arterial implant segment 18 is fully released from outer sheath 12, according to some embodiments. As shown, with the sheath 12 fully retracted, the arterial implant segment 18 may radially expand within the artery 70. Upon radial expansion of the artery 70, the arterial implant segment 18 may radially engage the wall of the artery 70. Also shown, in some embodiments, the arterial implant segment 18 may be angled as described herein with respect to the venous implant segment (e.g., the longitudinal axis of the arterial implant segment 18 may be angled with respect to the longitudinal axis of the venous implant segment 19) when the outer sheath 12 is fully retracted. To further retract the sheath 12, the control knob 26 of the delivery device 29 can be slid further proximally to its proximal-most position, while the handle 23 of the delivery device 29 remains in place to hold the nose cone 8 against the proximal wall of the vein 80. In some embodiments, the intermediate shaft 16 may remain fixed during retraction of the outer sheath 12 by the intermediate shaft connector 50, the intermediate shaft connector 50 being prevented from moving proximally by its interaction with the intermediate shaft connector stop 52 of the delivery device 29. It should be understood that while the operations of fig. 31 and 32 have been separately described, in practice the operations depicted and described in fig. 31 and 32 may be sequentially performed in a smooth manner. For example, the sheath 12 may be fully retracted in one movement by movement (e.g., sliding) of the control knob 26 of the delivery device 29 from its initial distal-most position to its proximal-most position, which may fully release the implant 13 from the sheath 12 in one movement.

Fig. 33 illustrates 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 section 19 may be held in place by the connecting struts 20 connected to the arterial implant section 18 and thus slidably released from the cavity 9 of the nose cone 8. Furthermore, as shown, when the venous implant section 19 is released from the cavity 9, it may radially expand within the vein 80. Upon radial expansion of the vein 80, the vein implant section 19 may radially engage the wall of the vein 80. Also as shown, the arterial implant segment 18 may provide a way to secure 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 encroach on the luminal space of the artery 70. Further, as shown, upon radial expansion, the distal end of the venous implant section 19 (as oriented proximal end herein) may radially expand at the distal wall of the artery 70 and form a fluid seal with the distal wall of the artery 70. The arterial implant segment 18 may also provide radial support to the artery 70 to ensure unobstructed and adequate blood flow in the artery 70 after implantation of the implant 13.

Fig. 34 illustrates an initial step of removing the delivery device 29, 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, the intermediate shaft 16 may guide the outer sheath 12 during this advancement step to facilitate secure engagement of the outer sheath 12 into the cavity 9 without the outer sheath 12 seizing the proximal end 11 of the nose cone 8. To move/advance the sheath 12 distally, the control knob 26 of the delivery device 29 may be moved (e.g., slid) distally to its distal-most position within the handle 23 while the handle 23 of the delivery device 29 remains in place. Further, in some embodiments, after the control knob 26 has been moved (e.g., slid) from an earlier step in the delivery process to its proximal-most position, the intermediate shaft 16 can be guided and advanced with the outer shaft 12 by the intermediate shaft connector 50 engaging the control knob 26, and the intermediate shaft connector 50 moved distally with the control knob 26 as the control knob 26 is moved distally.

Fig. 35 illustrates a subsequent process of removal of delivery device 29 according to some embodiments, wherein delivery system 29 is rotated about its axis, e.g., about 180 degrees, such that the proximal portion of tapered proximal end 11 of nose cone 8 is on the inside of bend 6. In this orientation, the gap 14 may be minimized, eliminated or substantially eliminated, and there may be flush contact between the proximal tapered end 11 and the outer sheath 12. Such a low profile configuration may facilitate removal of the nose cone 8 without engaging any anatomical features near the delivered implant 13 or AVF location 7. In some embodiments, the engagement between the sheath 12 and the proximal end of the nose cone 8 may be as shown in fig. 10B and described herein with respect to fig. 10B, for example, as the sheath 12 is advanced distally, the proximal tapered end of the nose cone 8 may be received within the lumen of the sheath 12, thereby forming a smooth transition between the sheath 12 and the proximal end of the nose cone 8, and thus facilitating removal of the delivery device 29.

Fig. 36 illustrates a subsequent process of removal of delivery device 29 according to some embodiments. As shown, as delivery device 29 is retracted proximally, nose cone 8 has passed through a substantial portion of implant 13 without interference. Implant 13 may have an unconstrained (e.g., radially expanded) delivered inner dimension that is greater than the outer dimension of nose cone 8 such that nose cone 8 does not experience excessive drag or interference with implant 13 when removed through implant 13. In some embodiments, as described herein with respect to fig. 13, if gap 14 is again formed during retraction of delivery device 29, the delivery device may be rotated again to minimize and/or eliminate gap 14, thereby facilitating removal of delivery device 29.

Fig. 37 shows complete removal of the delivery device 29 and only the guidewire 5 remaining according to some embodiments. Before removal of the guidewire 5, it may be desirable or advantageous to advance a balloon dilation catheter sized for the implant 13 and vasculature to facilitate full dilation of the implant 13. In some embodiments of the venous and arterial implant segments 19, 18 having different diameters, cross-sectional areas, and/or circumferences, different sized balloon dilation catheters may be used to facilitate full dilation of the venous and arterial implant segments 19, 18.

Fig. 38 shows the implant 13 completing delivery with the arterial implant segment 18 in the artery 70, the venous implant segment 19 in the vein 80, and the venous implant segment 19 forming an AVF between the artery 70 and the vein 80. As described herein, the implant 13 may be at least partially anchored in place by any one or more of the following: (i) Engagement between the wall of the artery 70 and the radially expanded arterial implant segment 18; (ii) Engagement between the wall of the vein 80 and the radially expanded vein implant section 19; (iii) Engagement between any anatomical structure, such as any portion of the wall of artery 70 and/or vein 80, and any anchors and/or barbs (not shown in fig. 38) of implant 13; and (iv) in embodiments in which implant 13 includes a continuous strut/ring 21, engagement between the distal wall of artery 70 and continuous strut/ring 21 (e.g., an anastomotic ring) of implant 13. As shown and described herein, the distal end of the venous implant section 19 (proximal end as oriented herein) may not occlude the lumen of the artery 70. In some embodiments, the arterial implant segment 18 may position the venous implant segment 19 through the connecting struts 20 such that the distal end (here oriented proximally) of the venous implant segment 19 may not occlude the lumen of the artery 70. In embodiments where implant 13 includes continuous struts/rings 21, continuous struts/rings 21 may form a fluid seal with the distal wall of artery 70. As also shown in fig. 38, in some embodiments, the venous implant section 19 (e.g., an axis of the venous implant section such as a longitudinal axis) may be angled between about 0 degrees and about 90 degrees relative to the arterial implant section 18 (e.g., an axis of the arterial implant section such as a longitudinal axis), as described herein. Further, implant 13 may include any one or more features, dimensions, characteristics, etc. of any of the embodiments of implant 13 described herein.

Referring to fig. 23, prior to implantation of implant 13, blood flow in artery 70 may be from right to left and blood flow in vein 80 may be from left to right. Referring to fig. 38, after implantation of implant 13, blood flow may be as follows: blood flow in the artery 70 may enter a side opening or port of the implant 13 (e.g., between the vein implant section 19 and the artery implant section 18) from right to left and as shown, and (i) flow through the proximal end of the artery implant section 18 (here oriented distally) and out of the distal end of the artery implant section 18 (here oriented proximally) to continue through the artery, and (ii) flow through the distal end of the vein implant section 19 (here oriented proximally) and out of the proximal end of the vein implant section 19 (here oriented distally) to flow into the vein 80 (and, for example, flow from left to right in the vein 80 after exiting the vein implant section 19). In some embodiments, with continued reference to fig. 38, after implant 13 is implanted as shown, blood flow through vein 80 may be at least partially occluded or completely occluded by vein implant segment 19 (e.g., left to right to left blood flow from implant 13). Arterial blood may flow through the venous implant section 19 of the implant 13 due to the pressure differential between the artery 70 and the vein 80. The flow of arterial blood in the vein 80 due to the implant 13 may advantageously result in an increase in the vein in at least one of its size (e.g., diameter), thickness, and blood flow rate. For example, the flow of arterial blood in the vein 80 due to the implant 13 may advantageously increase the diameter of the vein 80 to at least about 4mm, at least about 5mm, or at least about 6mm. In another example, the flow of arterial blood in the vein 80 due to the implant 13 may advantageously provide a blood flow rate in the vein 80 of at least about 400cc/min, at least about 500cc/min, or at least about 600cc/min. In some embodiments, implant 13 may guide the development of vein 80 into a single access point for hemodialysis. In some embodiments, the implant 13 may direct the vein 80 to form a diameter of at least about 6mm and a blood flow rate of at least about 600cc/min.

The methods and apparatus described by fig. 23-38 may be applied to create AVFs in the vasculature of any relevant area of the human body and for any purpose, including but not limited to creating access points for hemodialysis. For example, the method and apparatus described by figures 23-38 may be applied to create AVF between the femoral artery and vein.

Fig. 39 illustrates a method of bypassing a portion of an artery with an endovascular implant, according to some embodiments. An artery 75 is shown having an arterial branch 77 and an arterial occlusion 79. Also shown is a vein 85 adjacent to the artery 75, which in some embodiments may include a venous valve 87. Two implants 13 are also shown implanted such that one (e.g., the left one) produces an AVF between the artery 75 and vein 85 to the left (e.g., upstream) of the arterial occlusion 79 and one (e.g., the right one) produces an AVF between the artery 75 and vein 85 to the right (e.g., downstream) of the arterial occlusion 79.

The blood flow in the artery 75 may be left to right and may be blocked, substantially blocked, or partially blocked by the arterial occlusion 79 prior to implantation of the implant 13, thereby preventing normal flow of blood through the artery 75. When the arterial branch 77 is located to the left (e.g., upstream) of the arterial occlusion 79, the arterial branch 77 may receive blood flow from the artery, as indicated by the arrow in fig. 39. Also prior to 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.

After implantation of the implant 13 as shown, arterial blood flow may be as follows: blood flow in artery 75 may flow from left to right, through the distal end of arterial segment 18 of left implant 13 (according to the convention used herein) and out the proximal end of arterial segment 18 of left implant 13 (according to the convention used herein) and (i) continue to flow from left to right through the artery and either 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 the proximal end of venous segment 19 (according to the convention used herein) to flow into vein 85. If the venous valve 87 is positioned in the vein 85, as shown between the left implant 13 and the right implant 13, a valvular knife or other device may be used to destroy the venous valve 87 before or during implantation of the implant, such that arterial blood directed from the artery 75 to the vein 85 by the left implant 13 may continue past the (now destroyed) venous valve 87 after implantation of the implant. Arterial blood flow continues after being directed by the left implant 13 to the vein 85, and any interfering venous valves 87 are destroyed, arterial blood flow may continue as follows: arterial blood may continue to flow through vein 85 after flowing through vein implant section 19 of left implant 13, through any damaged vein valve 87 (if present), through the proximal end of vein implant section 19 of right implant 13, out the distal end of vein implant section 19 of right implant 13, through the side opening or port of right implant 13, and (i) to the left toward arterial occlusion 79 before being occluded by arterial occlusion 79, and (ii) to the right through the proximal end of arterial implant section 18 of the right implant, and out the distal end of arterial implant section 18 of the right implant and continue through artery 75. In this way, both implants 13 can be used to restore arterial blood flow in an artery with arterial occlusion 79. After implant 13 is implanted as shown, venous blood flow in vein 85 may be blocked by venous implant section 19 of right implant 13, as indicated by the return arrow in fig. 39. As described herein, both implants 13 may be covered with a graft material to facilitate redirection of blood flow, as discussed in fig. 39.

With continued reference to fig. 39, in some embodiments, the venous implant section 19 of the implant 13 may traverse the venous valve 87 and avoid the need to destroy the venous valve 87 prior to implantation (e.g., the radial stiffness of the implant may alone be sufficient to open the venous valve 87 and allow for desired blood flow through the venous valve 87). In some embodiments, the delivery device 29 includes sufficient axial rigidity to pass through the venous valve 87 and allow the venous implant section 19 of the implant 13 to be implanted through the venous valve 87. In some embodiments, two implants 13 may overlap, for example, a left implant vein implant section 19 may be implanted within a right implant vein implant section 19, and vice versa. In some embodiments, the two implants 13 may be spaced apart, taking into account vessel anatomy (such as any arterial branches 77) and any arterial occlusions 79. Any of the delivery methods described herein may be used to implant more than one implant 13, as shown in fig. 39, including the methods described in fig. 1-15 and the methods described in fig. 23-38; in which the delivery device may first enter the vein in front of the artery in the method described in fig. 1-15; in the method of fig. 23-38, the delivery device may first enter the artery prior to entering the vein. Further, as shown and described in fig. 39, implant 13 may be used to divert blood flow in the body in a variety of ways and is not limited to any of the descriptions provided herein. For example, blood flow may enter or leave the distal end of the distal implant segment 18 (i.e., arterial implant segment 18), blood flow may enter or leave a side opening or port between the proximal end of the distal implant segment 18 (i.e., arterial implant segment 18) and the distal end of the proximal implant segment 19 (i.e., venous implant segment 19), blood flow may enter or leave the proximal end of the distal implant segment 18 (i.e., arterial implant segment 18), blood flow may enter or leave the distal end of the proximal implant segment 19 (i.e., venous implant segment 19), and blood flow may enter or leave the proximal end of the proximal implant segment 19 (i.e., venous implant segment 19).

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

The foregoing description and examples are merely illustrative of the present disclosure and are not intended to be limiting. Each disclosed aspect and embodiment of the present disclosure may be considered alone or in combination with other aspects, embodiments, and variations of the present disclosure. Furthermore, unless otherwise indicated, the steps of the methods of the present disclosure are not limited to any particular order of execution. Modifications of the disclosed embodiments that incorporate the spirit and substance of the present disclosure will occur to those skilled in the art and such modifications are within the scope of the present disclosure.

As used herein, directional terms, such as "top," "bottom," "horizontal," "vertical," "longitudinal," "transverse," and "end," are used in the context of the illustrated embodiments. However, the present disclosure should not be limited to the directions shown. Indeed, other orientations are possible and are within the scope of the present disclosure. As used herein, terms relating to circular, such as diameter or radius, should be understood not to require a perfectly circular configuration, but rather should be applied to any suitable configuration having a cross-sectional area that may be measured from side to side. Terms generally associated with shapes, such as "circular" or "cylindrical" or "semi-circular" or "semi-cylindrical" or any related or similar terms, do not necessarily strictly conform to the mathematical definition of circular or cylindrical or other structure, but may include reasonably similar structures.

Unless specifically stated otherwise, or otherwise understood in the context of use, conditional language such as "may," "might," "perhaps," "for example," etc., as used herein are generally intended to convey that some embodiments include certain features, elements and/or states, while others do not. Thus, such conditional language is not generally intended to imply that features, elements, data and/or states are in any way required for one or more embodiments or that one or more embodiments must include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included in any particular embodiment or are to be executed.

Unless specifically stated otherwise, a connective language, such as the phrase "at least one of X, Y and Z," is used in the context to generally indicate that an item, term, etc., may be X, Y or Z. Thus, such connection language generally does not mean that certain embodiments require the presence of at least one of X, Y and Z.

The terms "approximately," "about," and "substantially" as used herein mean an amount that is approximately the amount that still performs the desired function or achieves the desired result. For example, in some embodiments, the terms "approximately," "about," and "substantially" may refer to an amount that is less than or equal to within 10% of the amount, as indicated above and below. The term "generally" as used herein means a value, quantity, or characteristic that substantially includes or tends to be a particular value, quantity, or characteristic. As an example, in certain embodiments, the term "substantially parallel" may refer to something that deviates from precisely parallel by less than or equal to 20 degrees, as indicated above and below.

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

Articles such as "a" or "an" should generally be construed to include one or more of the recited items unless specifically stated otherwise. Thus, phrases such as "a device configured as … …" are intended to include one or more of the enumerated devices. Such one or more enumerated devices may be collectively configured to perform the described listing. For example, a "processor configured to execute the quoted content A, B and C" may include a first processor configured to execute the quoted content a working with a second processor configured to execute the quoted content B and C.

The terms "comprising," "including," "having," and the like are synonymous and are used inclusively in an open-ended fashion, and do not exclude additional elements, features, acts, operations, etc. Also, the terms "some," "some," and the like are synonymous and are used in an open-ended fashion. Furthermore, the term "or" is used in its inclusive sense (rather than its exclusive sense) such that when used, for example, to connect a list of elements, the term "or" means one, some, or all of the elements in the list.

In general, the language of the claims should be construed broadly in light of 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 in the course of the application of the present application.

While systems, devices and methods for intravascular implants and precise placement thereof have been disclosed in the context of certain embodiments and examples, the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the embodiments and certain modifications and equivalents thereof. The various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of systems, devices and methods for intravascular implants and their precise placement. The scope of the present disclosure should not be limited by the specific disclosed embodiments described herein.

Certain features described in this disclosure in the context of separate implementations can be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can be implemented in multiple implementations separately or in any suitable subcombination. Although features may be described herein as acting in certain combinations, one or more features from a claimed combination can in some cases be excised from the combination, and the combination may be directed to a subcombination or variation of a subcombination.

While the methods and apparatus described herein are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the various embodiments described and the appended claims. Furthermore, any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like disclosed herein in connection with an embodiment may be used in all other embodiments described herein. Any of the methods disclosed herein need not be performed in the order described. Depending on the embodiment, one or more acts, events, or functions of any algorithm, method, or process described herein may be performed in a different order, may be added, combined, or omitted entirely (e.g., not all of the described acts or events are necessary for the practice of the algorithm). In some embodiments, acts or events may be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially. Furthermore, no element, feature, data, or step is essential or necessary for each embodiment. Moreover, all possible combinations, subcombinations, and rearrangements of the systems, methods, features, elements, modules, data, etc. are within the scope of the disclosure. Unless specifically stated otherwise, or otherwise understood in the context of use, use of sequential or chronological language, such as "then," "next," "after," "subsequent," etc., is generally intended to facilitate the progression of text and is not intended to limit the order of operations performed. Thus, some embodiments may be performed using sequences of operations described herein, while other embodiments may be performed after a different sequence of operations.

Furthermore, although operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in the order, and all operations need not be performed, to achieve desirable results. Other operations not depicted or described may be incorporated into the example methods and processes. For example, one or more additional operations may be performed before, after, concurrently with, or during any of the described operations. Moreover, in other implementations, operations may be rearranged or reordered. Moreover, 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 can generally be integrated in a single product or packaged into multiple products. Further, other embodiments are within the scope of the present disclosure.

Some embodiments have been described in conjunction with the accompanying drawings. Some of the figures are drawn and/or shown to scale, but such scale should not be limiting, as other dimensions and proportions are contemplated in addition to those shown, and are within the scope of the embodiments disclosed herein. The distances, angles, etc. are merely illustrative and do not necessarily have an exact relationship to the actual size and layout of the devices shown. Components may be added, deleted, and/or rearranged. Furthermore, any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like disclosed herein in connection with various embodiments may be used in all other embodiments set forth herein. Furthermore, any of the methods described herein may be implemented using any device suitable for performing the steps described.

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

In summary, various embodiments and examples of precisely placed endovascular implants, as well as devices and methods, have been disclosed. While systems, devices and methods for intravascular implants and precise placement thereof have been disclosed in the context of those embodiments and examples, the present 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 present disclosure expressly contemplates that various features and aspects of the disclosed embodiments can be combined with or substituted for one another. Therefore, the scope of the present disclosure should not be limited by the specific disclosed embodiments described herein, but should be determined only by a fair reading of the claims that follow.

The scope of the disclosure herein also includes any and all overlaps, sub-ranges, and combinations thereof. Language such as "up to", "at least", "greater than", "less than", "between", etc., includes the recited numbers. Numbers beginning with terms such as "about" or "approximately" include the numbers referenced and should be interpreted based on the circumstances (e.g., in which case they are as reasonably accurate as possible, such as + -5%, + -10%, + -15%, etc.). For example, "about 1V" includes "1V". Phrases preceding terms such as "substantially" include those phrases and should be construed based on the circumstances (e.g., in which case it is as reasonable as possible). For example, "substantially vertical" includes "vertical" unless otherwise indicated, all measurements are made under standard conditions, including temperature and pressure.

Claims (65)

1. A system for creating an arteriovenous fistula in a patient arm, the system comprising:

an intravascular delivery device configured for accessing an arm of a patient, wherein the intravascular delivery device is configured to be advanced into a superficial vein, into a through-branch vein, into a deep vein, and into an artery adjacent to the deep vein; and

an endoluminal implant, wherein the endovascular delivery device is configured to deliver the endoluminal implant in a radially compressed configuration into an arm of a patient, the endoluminal implant comprising:

a proximal implant segment including 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 proximal implant segment extends through the through-branch vein and the deep vein and the proximal end of the proximal implant segment is located within the through-branch vein; and

a distal implant segment connected to the proximal implant segment, the distal implant segment being releasable from the 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 a distal end 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 through-branch 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 divert flow from the artery into the shallow vein.

2. The system of claim 1, wherein the distal implant segment is configured to anchor on an arterial wall.

3. The system of claim 2, wherein the distal implant segment comprises a tubular body configured to provide radial support to the artery.

4. The system of any of the preceding claims, wherein the proximal implant segment comprises a tubular body configured to radially engage a wall of the through-branch vein.

5. The system of any of the preceding claims, wherein the distal end of the proximal implant segment is configured to be secured to a wall of an artery.

6. The system of claim 5, wherein the distal end of the proximal implant segment comprises an anchor configured to anchor against an arterial wall.

7. The system of any of the preceding claims, wherein one or both of the proximal implant section and the distal implant section are covered with a graft material.

8. The system of any of the preceding claims, wherein the implant comprises a side opening between a distal end of the proximal implant section and a proximal end of the distal implant section, wherein when the proximal implant section is in a radially expanded configuration extending through the through-the-branch vein and the deep vein, and the distal implant section is in a radially expanded configuration within the artery, blood flowing through the artery enters the side opening and (i) flows through the proximal end of the distal implant section and out of the distal end of the distal implant section, and (ii) flows through the distal end of the proximal implant section and out of the proximal end of the proximal implant section.

9. The system of any of the preceding claims, wherein the distal end of the proximal implant section comprises an anastomotic ring.

10. The system of any of the preceding claims, wherein the distal end of the proximal implant segment is configured at an angle of about 0 degrees to about 90 degrees relative to an axis of the distal implant segment.

11. The system of any of the preceding claims, wherein the distal implant segment is connected to the proximal implant segment by at least one connecting strut.

12. The system of any of the preceding claims, wherein the delivery device comprises a sheath configured to constrain the endoluminal implant within a distal end of the sheath in a radially compressed configuration.

13. The system of claim 12, wherein the delivery device further comprises a burr that is advanceable into an artery, and wherein the distal end of the sheath is configured to be inserted into a cavity of the burr to advance into an artery with the burr.

14. The system of claim 13, wherein the nose cone comprises a tapered proximal end configured to engage a proximal wall of the artery.

15. The system of claim 13 or 14, wherein the delivery device is configured to, after the distal end of the sheath is advanced into the artery with the nose cone:

the sheath is retracted in a proximal direction relative to the nose cone to expand the proximal implant section within the deep vein and the through-branch vein; and

after the proximal implant segment is expanded within the deep vein and the through-branch vein to expand the distal implant segment within the artery, the nose cone is advanced distally relative to the distal implant segment.

16. The system of claim 15, wherein the delivery device is configured such that, after the distal implant segment expands within the artery, the sheath can be advanced through the expanded proximal implant segment and expanded distal implant segment into engagement with the nose cone to facilitate removal of the nose cone with the sheath from the artery.

17. The system of any of claims 13-16, wherein the delivery device further comprises a guidewire shaft configured to be advanced over a guidewire, wherein the nose cone is secured to the guidewire shaft.

18. An endoluminal delivery device comprising:

a nose cone including a proximal tapered end, a central lumen, a distal tapered end, and a longitudinal axis, an

A flexible sheath comprising a longitudinal axis,

wherein the device is configured such that the distal end of the flexible sheath is configured to be positioned within the central lumen of the burr such that when the longitudinal axis of the flexible sheath is not coaxial with the longitudinal axis of the burr, a gap is formed between the proximal tapered end of the burr and the sidewall of the flexible sheath when the flexible sheath enters the central lumen of the burr at the proximal tapered end of the burr.

19. The device of claim 18, wherein the nose cone comprises a slit.

20. The device of claim 19, wherein the slit is located at a proximal tapered end of the nose cone.

21. An endoluminal 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 including a flow lumen therethrough,

Wherein the at least one axially oriented connection strut serves as the sole connection between the proximal implant segment and the distal implant segment,

wherein the axial length of the proximal implant segment is longer than the axial length of the distal implant segment,

wherein the implant comprises a shape memory material.

22. The implant of claim 21, the implant configured such that when the implant is in a non-stressed state, the distal implant section comprises a diameter, circumference, and/or cross-sectional area that is different than a diameter, circumference, and/or cross-sectional area of the proximal implant section.

23. The implant of claim 21 or 22, the implant configured such that when the implant is in a non-stressed state, the distal implant section comprises a diameter, circumference, and/or cross-sectional area that is less than a diameter, circumference, and/or cross-sectional area of the proximal implant section.

24. The implant of any one of claims 21-23, the implant configured such that the proximal implant section comprises a variable diameter, circumference, and/or cross-sectional area when the implant is in a non-stressed state.

25. The implant of any one of claims 21-24, configured such that a distal edge of the proximal implant segment comprises a continuous strut and/or ring.

26. The implant of any one of claims 21-25, configured such that a distal edge of the proximal implant section comprises a continuous strut and/or ring with one or more anchors.

27. The implant of any one of claims 21-26, the implant configured such that the proximal implant section includes struts of uniform length.

28. The implant of any one of claims 21-26, the implant configured such that the proximal implant section comprises struts of variable length and/or variable width.

29. The implant of any one of claims 21-28, the implant configured such that the distal implant section is longitudinally offset from the proximal implant section when the implant is in a non-stressed state.

30. The implant of any one of claims 21-29, wherein the proximal implant section comprises a biocompatible graft material.

31. The implant of any one of claims 21-30, wherein the distal implant section comprises a biocompatible graft material.

32. The implant of claim 30 or 31, wherein the implant comprises a porous or non-porous laminate layer.

33. The implant of any one of claims 21-32, wherein the implant comprises a coating comprising heparin and/or a therapeutic agent.

34. An endoluminal implant for creating an arteriovenous fistula, comprising:

a proximal implant segment comprising a proximal end and a distal end, the proximal implant segment configured to extend through a ramus vein and a deep vein, wherein the proximal end of the proximal implant segment is configured to be positioned within the ramus vein; and

a distal implant segment connected to the proximal implant segment and configured to be positioned within an artery adjacent the deep vein, wherein a 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 section is configured to divert flow from the artery into a superficial vein connected to the perforator vein.

35. The endoluminal implant of claim 34 wherein the proximal implant section and the distal implant section comprise expandable tubular bodies.

36. The endoluminal implant of claim 34 or 35 wherein the endoluminal implant comprises a side opening between the distal end of the proximal implant section and the proximal end of the distal implant section such that blood flowing through the artery enters the side opening and (i) flows through the proximal end of the distal implant section and out 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, out the proximal end of the proximal implant section, into the through-the-branch vein and the superficial vein.

37. The endoluminal implant of any one of claims 34-36 wherein the proximal implant section is at an angle between about 0 to about 90 degrees relative to an axis of the distal implant section.

38. An endoluminal implant for creating an arteriovenous fistula, comprising:

a 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 be collapsed for delivery into a patient and expandable to radially engage an inner wall of a vein; and

an 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 be collapsed for delivery into a patient and expandable to radially engage an inner wall of an artery located adjacent a vein;

wherein the second end of the venous implant section is connected to the first end of the arterial implant section to allow the arterial implant section to be angled relative to the venous implant section when the venous implant section and the arterial implant section are in the expanded configuration, and wherein the angle of the arterial implant section relative to the venous implant section increases a distance along one side of the implant between the second end of the venous implant section and the first end of the arterial implant section to provide a side opening into the implant; and

Wherein when the vein implant segment radially engages the inner wall of the vein and the artery implant segment radially engages the inner wall of the artery adjacent the vein, blood flowing through the artery enters the side opening and (i) flows through the first end of the artery implant segment and out the second end of the artery implant segment, and (ii) flows through the second end of the vein implant segment and out the first end of the vein implant segment.

39. A delivery device for delivering a vascular implant between a vein and an artery, comprising:

an outer sheath configured to constrain the implant in a low profile configuration at a distal end of the outer sheath; and

a nose cone comprising a proximal end, a distal end, and a cavity, wherein the distal end of the outer sheath is insertable into the cavity for advancing the nose cone and the distal end of the outer sheath through the vein and into the artery;

wherein the sheath is retractable in a proximal direction relative to the nose cone to expand a distal section of the implant within the cavity;

wherein the sheath is further retractable in a proximal direction relative to the nose cone to expand the proximal section of the implant intravenously; and

wherein the nose cone is distally advanceable relative to the distal segment of the implant after the proximal segment expands intravenously to release the distal segment of the implant from the cavity within the artery.

40. The delivery device of claim 39, wherein the distal end of the nose cone is tapered.

41. The delivery device of claim 39 or 40, wherein a proximal end of the nose cone is tapered.

42. The delivery device of any of claims 39-41, wherein a proximal end of the nose cone is angled relative to a longitudinal length of the nose cone.

43. The delivery device of any of claims 39-42, wherein the tapered proximal end of the nose cone is configured to engage a proximal wall of the artery after the nose cone is advanced into the artery.

44. The delivery device of any of claims 39-43, wherein the distal end of the sheath is advanceable through the distal section of the implant and into the cavity after intra-arterial release of the distal section of the implant.

45. The delivery device of any of claims 39-44, wherein after releasing the distal section of the implant within the artery, the distal end of the sheath is advanceable through the distal section of the implant to engage the proximal end of the nose cone such that the nose cone enters the distal end of the sheath.

46. The delivery device of any of claims 39-45, further comprising a guidewire shaft configured to advance over a guidewire, wherein the nose cone is fixed to the guidewire shaft.

47. The delivery device of any of claims 39-46, further comprising a control knob connected to a proximal end of the outer sheath, the control knob configured to retract and/or advance the outer sheath when the control knob is moved proximally and/or distally, the control knob disposed at least partially within a handle of the delivery device.

48. The delivery device of claim 47, wherein the control knob is configured to releasably lock to a proximal-most and/or distal-most position within the handle.

49. The delivery device of any one of claims 39-48, further comprising an intermediate shaft within the outer sheath configured to prevent proximal sliding of the implant during retraction of the outer sheath.

50. The delivery device of claim 49, wherein the distal end of the intermediate shaft guides the distal end of the sheath as the sheath advances the cavity.

51. The delivery device of claim 49, further comprising an intermediate shaft connector disposed within the handle and connected to the proximal end of the intermediate shaft, the intermediate shaft connector configured to engage the control knob and advance the intermediate shaft with the outer sheath as the outer sheath is advanced into the cavity.

52. The delivery device of any of claims 39-51, further comprising the implant constrained within a distal end of the outer sheath.

53. A method of producing an arteriovenous fistula in a patient's arm, comprising:

delivering an endoluminal implant in a contracted configuration into a patient, the endoluminal implant comprising a proximal implant section and a distal implant section, wherein the proximal implant section is connected to the distal implant section;

extending an endoluminal implant between the deep vein and an artery adjacent the deep vein, wherein a proximal implant segment extends through the through-the-branch vein and the deep vein, and a distal implant segment is located within the artery; and

radially expanding the proximal implant segment to engage the proximal implant segment with the wall of the through-branch vein and radially expanding the distal implant segment to engage the distal implant segment with the wall of the artery and provide radial support to the artery such that blood flowing through the artery shunts from the artery into the shallow vein connected to the through-branch vein.

54. The method of claim 53, wherein the endoluminal implant comprises a side opening between the distal end of the proximal implant section and the proximal end of the distal implant section such that after the proximal implant section radially expands to engage the wall of the through-branch vein and the distal implant section 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 section and the distal end of the distal implant section to continue flowing through the artery, and (ii) flows through the distal end of the proximal implant section and out the proximal end of the proximal implant section to flow into the through-branch vein and into the superficial vein.

55. The method of claim 53 or 54, wherein the proximal implant segment and the distal implant segment comprise tubular bodies.

56. The method of any one of claims 53-55, further comprising anchoring a distal end of the proximal implant segment to the arterial wall.

57. The method of any one of claims 53-56, wherein the proximal implant segment is angled relative to an axis of the distal implant segment after the proximal implant segment is radially expanded to engage a wall of the through-branch vein and the distal implant segment is radially expanded to engage a wall of the artery.

58. The method of claim 57, wherein the proximal implant segment is angled from about 0 degrees to about 90 degrees relative to an axis of the distal implant segment.

59. The method of any one of claims 53-58, wherein the endoluminal implant is delivered into the patient within a sheath that constrains the endoluminal implant at a distal end of the sheath.

60. The method of claim 59, wherein the distal end of the sheath is advanced into an artery within the cavity of the nose cone.

61. The method of claim 60, wherein the proximal implant segment is released from the sheath by proximally retracting the sheath relative to the nose cone to radially expand into engagement with the wall of the through-the-branch vein.

62. The method of claim 61, wherein the distal implant segment radially expands into engagement with the arterial wall by distally advancing the nose cone relative to the distal implant segment.

63. The method of claim 62, further comprising advancing the sheath distally through the radially expanded proximal implant section and the radially expanded distal implant section into engagement with the burr and proximally retracting the sheath into engagement with the burr through the radially expanded proximal implant section and the radially expanded distal implant section.

64. The method of claim 63, wherein the nose cone includes a tapered proximal end that engages a wall of the artery when the sheath is retracted proximally to release the proximal implant section.

65. The method of claim 64, wherein the burr rotates within the artery after the burr has been advanced distally to release the distal implant section and before the sheath engaged with the burr is retracted proximally by the radially expanded proximal implant section and the radially expanded distal implant section.