FIELD OF THE INVENTION

[0001] This invention relates to anastomotic connector devices. In particular, this invention relates to a vascular access device for use in hemodialysis and Other procedures, such as in the cardiovascular field, where short-term and long-term access is required.

BACKGROUND OF THE INVENTION

[0003] In the United States alone, approximately 400,000 people have end-stage renal disease requiring chronic hemodialysis. Hemodialysis replaces kidney function by removing toxins from the blood mat are normally removed by healthy kidneys. In order to effectively remove toxins, blood must be passed at a high blood flow rate through a hemodialysis machine. This high blood flow is best achieved by the creation of a permanent vascular access site that includes an arteriovenous (AV) anastomosis in which a vein is attached to an artery to form a high-flow shunt or fistula.

[0003] Typically, a vein may be directly attached to an artery, but it takes from six to eight weeks before the fistula has sufficiently matured (time between placement and cannulatjon for dialysis) to provide adequate blood flow for use with hemodialysis. Moreover, a direct anastomosis may not be feasible in all patients due to anatomical considerations. Other patients may require the use of artificial graft material to provide an access site between the arterial and venous vascular systems. Because of the length of time required for a fistula to mature a patient needing dialysis will typically require a temporary access device, such as a Quinton catheter, to be inserted for hemodialysis access until the fistula has matured. The use of a temporary catheter access exposes the patient to additional risk of bleeding and infection, as well as discomfort, and is associated with a 91% higher mortality rate compared to fistulas. In trying to increase the prevalence of fistulas in the U.S., a proportional rise in catheter use has been documented.

[0004] Therefore, what is needed is an improved vascular access device that addresses the foregoing problems. BRIEF SUMMARY OF THE INVENTION

[0005] The present invention addresses the foregoing problems by allowing a minimally invasive connection to be created between an artery and a vein in the arm of a patient without the need for creation of a surgical anastomosis.

[0006] In one aspect of the invention a device for connecting an artery and vein to create an arteriovenous anastomosis for hemodialysis is provided. The connector device includes a venous connector and an arterial connector. The arterial connector may comprise a stent constructed of a shape-memory material and optionally covered with a non-porous material to prevent leakage. The first (or distal) end of the arterial connector is sized to fit (-3-5 mm diameter) into a fluid arterial passageway of a patient and most preferably the radial artery of a patient and the second end (or proximal) is sized (~7 mm diameter) to receive the second end (proximal) of the venous connector. In other words _* the inner diameter of the proximal end of the arterial connector is greater than the outer diameter of the proximal end of the venous connector. Depending on the anatomy of a particular patient the length of the arterial and venous connectors may be from approximately 4 cm to 8 cm.

[0007] In another aspect of the invention, the venous connector may comprise a stent constructed of a shape-memory material and optionally covered with a non- porous material to prevent leakage, A first end (or distal) of the venous connector is sized (5-7 mm diameter) to fit into a fluid venous passageway of a patient and most preferably the cephalic vein of a patient. A second (proximal) and is configured to be received by the proximal end of the arterial connector. In other words, the proximal end of the venous connector has an outer diameter that is smaller than the inner diameter of the proximal end of the arterial connector. The first (distal) ends of the arterial and venous connectors may have an outer diameter that is greater than the outer diameter of the second (proximal) ends. Depending on the anatomy of a particular patient the length of the venous connector may be from approximately 4 cm to 8 cm.

[0008] Both the arterial connector and the venous connector may include an optional anchoring device at the first end thereof and in the case of the arterial connector optionally also at the second end thereof. The anchoring device may include one or more barbs on the first end, which extend radially outward from a longitudinal axis of the main body and are configured to secure the arterial or venous connector within the fluid passageway either by applying radial pressure to the vessel wall or by piercing anchoring the connector to the wall. In the case of a plurality of barbs comprising the anchoring device, the barbs may circurnferentially surround the first end of the arterial or venous connector.

[0009] In another aspect of the invention, the two connectors are delivered into the radial artery and cephalic vein through a 3 cm incision via the Seldinger technique over a guide wire/sheath system individually. The two connectors may be inserted into one another to create a radial pressure/interference fit and a stay suture maybe placed at the site of pyre overlap between the two connectors.

[0010] In another aspect of the invention, the anastomotic connector couples the radial artery to the cephalic vein in the location of the forearm without the need for graft material connecting the two connectors.

[0011] In another aspect of the invention, a minimally invasive way to create a fistula using two connectors is provided. No graft material is required to join the two connectors.

[0012] In another aspect of the invention, the arterial connector is not a conventional "end to side ^* ' anastomotic connector but rather an "end to end" connector. An end-to-side anastomosis is one in which the arterial connector couples to the artery at a right angle or perpendicular to the arterial wall so as not to obstruct flow in the vessel. An end-to-end anastomosis is one in which the venous connector attaches to the vein in a way that the venous connector and vessel are coaxial.

[0013] In the present invention, the arterial and venous connectors as end-to-end because they accomplish a coaxial configuration with the vessel despite the entrance point.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] For a better understanding of the invention, and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which: [0015] FIG. 1A is an illustration of the venous connector in accordance with the end to end arterial venous connector system in accordance with the invention.

[0016] FIG. IB is an illustration of the arterial connector in accordance with the end to end arterial venous connector system in accordance with the invention.

[0017] FIG. 2 is an illustration of the arterial connector coupled to the venous connector and inserted into an artery and vein, respectively.

[0018] FIG, 3 is a detailed view of the body of the venous connector and/or arterial connector in accordance with the invention showing the optional anchoring device.

[0019] FIG. 4 is a view of the venous connector and/or arterial connector showing the optional biocompatible coating with the non-coated distal end.

[0020] FIGv 5 is a view of the venous connector and/or arterial connector and showing a second aspect of the optional biocompatible coating showing a distal-most coated end with an optional non-coated anchoring device.

[0021] FIG. 6 is a view of the frame-work structure of he arterial and venous anchoring device laid flat in accordance with an aspect of the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0022] Referring now to FIG. 1, an end-to-end anastomotic connector 10 is depicted. The anastomotic connector 10 comprises a two-piece anastomotic connector that connects the radial artery 12 to the cephalic vein 14 in the location of the forearm without the need for graft material joining the two connectors together.

[0023] The venous connector 16 includes a conical-shaped body portion 18 having a first venous end 20 and a second venous end 22 and defines a lumen 17 having a blood flow path therethrough. The first venous end 20 may include an anchoring structure 28. Anchoring structure 28 may comprise a plurality of hooks, barbs, tines, prongs and other types of curved or angled fasteners designed to anchor the venous connector to an inner surface 40 of the venous wall 42. The anchoring structure 28 may circurnferentially surround the first venous end 20. As seen in FIG. 4 the anchoring structure 28 may comprise a single row of barbs 28 that extend radially outward from a longitudinal axis of the venous connector to securely seat the connector against the venous wall 40 or may comprise two or more rows of barbs 28 as best seen is FIG. 5. A diameter Dl of the first venous end 20 is larger than a diameter D2 of the second end 22,

[0024] Conical-shaped body portion 18 may comprise a metal frame structure as best seen in FIG. 3. Those of skill in the art will appreciate, however^ that the metal frame structure of the venous connector may include almost any configuration of struts and connectors known to those of skill in the art. The outer diameter of Dl of first end 20 of main body 18 is greater than the outer diameter D2 of second end 22 to ensure it is property seated in a venous fluid passageway. In addition, the outer diameter D2 is sized to ensure an interference fit within the second end 32 of arterial connector 26 as best seen in FIG.2.

[0025] In one aspect of the venous connector depicted in FIG. 4 the first end 20, which is received within a vessel wall is non-coated or bare while the body 18 is coated. Alternatively, some portions of the venous anchor may be coated while other portions may be non-coated to expose the anchoring structure 28 that circumferentially surrounds the first end as seen in FIG.5. As will be appreciated by those of ordinary skill in the art, the venous anchor device 16 in accordance with the invention, and as best seen in FIGS. 4 and S, is structured to provide a secure, leak- free connection to a venous vessel passageway. Therefore, it is contemplated that a fluid impermeable, biocompatible polymer SO may be deposited on portions of the venous connector 16 to fill the interstices of the struts comprising the coriical-shaped main body 18 to ensure a leak-tight seal when implanted in the venous fluid passageway. Such biocompatible materials may include, but are not limited to, expanded Polytetrafluoroethylene ("ePTFE"), polyester, silicone composites, or various other plastics and elastomers or combinations thereof. In an exemplary embodiment, the venous anchor device is coated with a PTFE coating to prevent leakage of blood or other fluids from the portion of the device that transports fluid from the first anchor device through the graft and to the second anchor device. The PTFE coating is applied by a process including forming a dispersion of polymeric nanofibers, a fiberizing polymer, and a solvent, the dispersion having a viscosity of at least about 50,000 cPs. The venous connector 16 may be positioned over a tubular polymeric structure. Nanofibers from the dispersion are electrospun onto the tubular frame of the device and then the devices are heated. Alternatively, the venous anchor device is coated by extruding tubes of polytetrafluoroethylene (PTFE) on the inside of the device and one on the outside. The two layers that are formed are heated to meld together. Other polymers that may be useful in coating the present devices are flucninatedethylenepropylene (FEP), perfluoroalkoxy (PFA), polyvinylidene fluoride (PVDF), tetrafluoroethyiene, hexafluoropropylene, polyetbylenes such as HDPE, MDPE and LDPE, polyethylene terepthalate polyester (PET), polyetheretherketone (PEEK) and similar polymers having low coefficients of friction.

[0026] As described previously and as alternatively depicted in FIG. 4 the first end 20 of the venous anchor device 16 may be left uncoated while the main body 18 is coated. Alternatively, as shown in FIG. 5, the venous connector 16 may have the distal-most portion of the first end 20 coated while the plurality of barbs 2% is uncoated to ensure barbs 18 are free to lie against vessel wall. Those of skill in the art will appreciate that barbs 18 may pierce the vessel wall or may simply lie adjacent the vessel wall without piercing it. The plurality of barbs 28 are configured to seat the venous connector in the vessel wall to ensure it does not dislodge from the vessel wall. In addition, upon deployment barbs 28 restrict further expansion of the venous anchor device when the barbs 28 anchor it against the vessel wall. Those of skill in the art will appreciate mat the distal end 29 of the barbs 28 is integrally formed with the metal frame structure of the main body 18 while the proximal end 31 is free or unattached like the tines of a comb or a pitchfork.

[0027] Those of skill in the art will appreciate that although it is contemplated that the venous connector 16 is coated there is no backflow in the venous connector due to the arterial pressure of the blood flowing through it. This minimizes any leakage that may occur at the entry point of the device in the venous wall. In addition, due to the arterial pressure those of skill in the art will appreciate that the proximal end of the venous connector would necessarily need to be inserted into the proximal end of the arterial connector. [0028] Venous connector 16 may be either self-expanding, such as so-called shape- memory materials, or non-self-expanding, such as stainless steel. In forming the exemplary venous connector, a tubular length of metal is used to cut the venous anchor device 16 and integrally form the struts and connectors of the main body 18 as well as barbs 28. As discussed previously, the metal material used in the exemplary venous connector 16 should be both resilient and capable of being heat treated to substantially set a desired shape. Preferably, the metal from which venous connector 16 is cut exhibits a high modulus of elasticity that is biocompatible and has superior compressibility allowing the venous connector 16 to be self-expandable.

[0029] One class of materials which meet these qualifications is so-called shape memory alloys. Such alloys tend to have a temperature induced phase change which will cause the material to have a preferred configuration which can be fixed by heating the material above a certain transition temperature to induce a change in the phase of the material. When the alloy is cooled back down, the alloy will "remember*' the shape it was in during the heat treatment and will tend to assume that configuration unless constrained from so doing.

[0030] One particularly preferred shape memory alloy for use in the present method is Nitinol, an approximately stoichiometric alloy of nickel and titanium, which may also include other minor amounts of other metals to achieve desired properties. NiTi alloys such as nitinol, including appropriate compositions and handling requirements, are well known in the art and such alloys need not be discussed in detail here.

[0031] Such NiTi alloys are preferred, at least in part, because they are commercially available, have a high yield strain and more is known about handling such alloys than other known shape memory alloys, NiTi alloys are also very elastic- -they are said to be "superelastic" or "pseudoelastic." This elasticity will help a device of the invention return to a present expanded configuration for deployment into a blood vessel. However, any suitable self-expanding material may be used as will be appreciated by those of ordinary skill in the art. [0032] As hereinafter described, prior to implantation the venous connector 16 is collapsed inside a delivery device or sheath, Upon introduction into a vessel, the first end 20 of the connector freely self-expands to its original dimensions. The self- expanding behavior of the venous connector 16 is due to the relatively high modulus of elasticity of the shape-memory material, which imparts superior spring-like properties to the venous connector 16,

[0033] The arterial connector 26 includes a substantially conically-shaped, resilient body portion 28 having a first (distal) arterial end 30 and a second (proximal) arterial end 32 and defines a lumen comprising a blood flow path therethrough. A diameter D3 of the first arterial end 30 is smaller than a diameter D4 of the second arterial end 32. The first end 30 is sized and configured to be positioned within a radial artery. The diameter 1)4 of the second arterial end 32 is larger than a diameter D2 of the second venous end 22. Thus, the second venous end 22 of venous connector 16 is configured to be received by the second arterial end 32 of the arterial connector 26 in an interference fit.

[0034] The arterial connector 26 may optionally include a plurality of finger-like tines 33 at the second or proximal end thereof as best seen in FIG. 2. Finger-like tines 33 extend inwardly from the main body 38 at an acute angle. However, those of skill in the art will appreciate that finger-like lines 33 can extend inwardly from the arterial connector 26 at any angle that will cause them to exert a compressive grasping force on the body of the venous connector 16 when operably coupled therewith. Because finger-like tines 33 extend outwardly from the arterial connector 26 they exert a compressive force on the venous connector 16 that prevents it from de-coupling from the arterial connector after placement Those of skill in the art will also appreciate that the force of the arterial blood flow will also act to maintain the arterial connector 26 coupled to the venous connector 16.

[0035] It is contemplated that the main bodies 18, 38 of the venous connector 16 and the arterial connector will structurally be the same except for the presence of an anchoring device 28, which is optional on the arterial connector. If present, the anchoring device would be positioned circumferentiaUy around the first arterial end 30. The main body portions of both the venous connector and arterial connector may comprise a single layer of shape-memory material or a two-layer construct without departing from the scope of the invention.

[0036] The frame-like structure of the arterial and venous connector has a loose configuration or in other words a column pitch (CP) that is substantially equivalent along the length of the device. In one aspect of the invention, the column pitch is approximately 0.185 inches which allows the connectors to easily bend. Those of skill in the art will appreciate, however, that other column pitches and other frame-like structures can be used and still be within the scope of the invention. When the venous connector is exposed to arterial pressure the loosely configured connector will stretch. When the two connectors ate positioned within their respective vessels they will assume an outer diameter equal to the inner diameter of the vessel into which it is deployed. If optional anchoring devices are used, as they engage the vessel wall the anchoring device will prevent die vessel from further expansion.

[0037] As can be seen in FIG. 6 the frame-like structure of the arterial and venous connector includes a plurality of rows 410 of openly-formed sinusoidal-shaped struts. Each row of sinusoidal-shaped struts 410 is connected to the subsequent row by two connecting members 426 that extend from a mid-portion of the strut to the curved portion of the strut in the subsequent row. Each row is connected to an adjacent row by two connecting members 426 each of said connecting members having a first portion 428 that extends radially from a mid-portion of the strut and a second portion 430 that extends axially from the first portion, the second portion 430 of the connecting member is connected to a peak 432 of the sinusoidal-shaped strut in the adjacent row.

[0038] Additionally, it may be preferable to provide the arterial 26 and venous 16 connectors of the invention with an inner surface that is contoured to allow smooth arterial or venous blood flow into and out of the connector devices. As those of ordinary skill in the art will appreciate, providing a non-throrabogenic surface minimizes the creation of recirculation or stagnation zones with high shear or dwell times that could otherwise lead to clotting,

[0039] It is also contemplated that the inner or outer surface of the arterial 26 and venous 16 connectors be configured to deliver and release therapeutic substances such as anti-microbial agents, anti-inflammatory agents, anti-proliferative agents (e.g. taelipaxel), growth factors, stem cells, collagen and the like. Those of ordinary skill in the art will appreciate that these therapeutic agents may be coupled with the connector and/or the external or internal surface of the connector by means such as being encased or embedded in the optional biocompatible coating, applied to a textured external surface of the connector, contained within pockets of the connector on either an internal or external surface, and the like.

[0040] The present invention provides a minimally invasive way to create an end- to-end fistula using two connectors without the need for graft material to couple the two connectors. The arterial connector comprises an end-to-end connector as opposed to the more conventional end-to-side connectors.

[0041] Based upon the present disclosure and after viewing the exemplary embodiment of the arterial and venous connectors 26, 16 presented herein, the many advantages and benefits provided by the invention will be appreciated by those of ordinary skill in the art. One advantage is that the present invention provides a minimally invasive way to create an end-to-end fistula using two connectors without the need for graft material to couple the two connectors.

[0042] The arterial connector comprises an end-to-end connector as opposed to the conventional end-to-side connectors,

[0043] Another advantage is that the arterial and venous connectors of the invention may be implanted with minimally invasive surgery rather than with an "open surgery" approach. The implantation method is therefore less invasive for the patient and faster for the surgeon.

[0044] Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.