Abstract:
A device for creating an arteriovenous (AV) fistula comprises an elongate member, a distal member connected to the elongate member and movable relative to the elongate member, and a heating member disposed on at least one of the movable distal member and the elongate member. The distal member comprises structure for capturing tissue to be cut to create the fistula, and the heating member is adapted to cut through the tissue to create the fistula. The elongate member comprises an elongate outer tube. A shaft connects the distal member to the elongate member, and is extendable and retractable to extend and retract the distal member relative to the elongate member.

Description:
[0001]    This application claims the benefit under 35 U.S.C. 119(e) of the filing date of Provisional U.S. Application Ser. No. 61/354,903, entitled Systems and Methods for Creating Arteriovenous Fistulas, filed on Jun. 15, 2010, and Provisional U.S. Application Ser. No. 61/480,818, entitled Intravascular Arterial to Venous Anastomosis and Tissue Welding Catheter, filed on Apr. 29, 2011. Both applications are expressly incorporated herein by reference, in their entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    In the body, various fluids are transported through conduits throughout the organism to perform various essential functions. Blood vessels, arteries, veins, and capillaries carry blood throughout the body, carrying nutrients and waste products to different organs and tissues for processing. Bile ducts carry bile from the liver to the duodenum. Ureters carry urine from the kidneys to the bladder. The intestines carry nutrients and waste products from the mouth to the anus. 
         [0003]    In medical practice, there is often a need to connect conduits to one another or to a replacement conduit to treat disease or dysfunction of the existing conduits. The connection created between conduits is called an anastomosis. 
         [0004]    In blood vessels, anastomoses are made between veins and arteries, arteries and arteries, or veins and veins. The purpose of these connections is to create either a high flow connection, or fistula, between an artery and a vein, or to carry blood around an obstruction in a replacement conduit, or bypass. The conduit for a bypass is a vein, artery, or prosthetic graft. 
         [0005]    An anastomosis is created during surgery by bringing two vessels or a conduit into direct contact. The vessels are joined together with suture or clips. The anastomosis can be end-to-end, end-to-side, or side-to-side. In blood vessels, the anastomosis is elliptical in shape and is most commonly sewn by hand with a continuous suture. Other methods for anastomosis creation have been used including carbon dioxide laser, and a number of methods using various connecting prosthesis, clips, and stents. 
         [0006]    An arterio-venous fistula (AVF) is created by connecting an artery to a vein. This type of connection is used for hemodialysis, to increase exercise tolerance, to keep an artery or vein open, or to provide reliable access for chemotherapy. 
         [0007]    An alternative is to connect a prosthetic graft from an artery to a vein for the same purpose of creating a high flow connection between artery and vein. This is called an arterio-venous graft, and requires two anastomoses. One is between artery and graft, and the second is between graft and vein. 
         [0008]    A bypass is similar to an arteriovenous graft. To bypass an obstruction, two anastomoses and a conduit are required. A proximal anastomosis is created from a blood vessel to a conduit. The conduit extends around the obstruction, and a second distal anastomosis is created between the conduit and vessel beyond the obstruction. 
         [0009]    As noted above, in current medical practice, it is desirable to connect arteries to veins to create a fistula for the purpose of hemodialysis. The process of hemodialysis requires the removal of blood from the body at a rapid rate, passing the blood through a dialysis machine, and returning the blood to the body. The access to the blood circulation is achieved with catheters placed in large veins, prosthetic grafts attached to an artery and a vein, or a fistula where an artery is attached directly to the vein. 
         [0010]    Fistulas for hemodialysis are required by patients with kidney failure. The fistula provides a high flow of blood that can be withdrawn from the body into a dialysis machine to remove waste products and then returned to the body. The blood is withdrawn through a large access needle near the artery and returned to the fistula through a second large return needle. These fistulas are typically created in the forearm, upper arm, less frequently in the thigh, and in rare cases, elsewhere in the body. It is important that the fistula be able to achieve a flow rate of 500 ml per minute or greater. Dialysis fistulas have to be close to the skin (&lt;6 mm), and large enough (&gt;4 mm) to access with a large needle. The fistula needs to be long enough (&gt;6 cm) to allow adequate separation of the access and return needle to prevent recirculation of dialysed and non-dialysed blood between the needles inserted in the fistula. 
         [0011]    Fistulas are created in anesthetized patients by carefully dissecting an artery and vein from their surrounding tissue, and sewing the vessels together with fine suture or clips. The connection thus created is an anastomosis. It is highly desirable to be able to make the anastomosis quickly, reliably, with less dissection, and with less pain. It is important that the anastomosis is the correct size, is smooth, and that the artery and vein are not twisted. 
       SUMMARY OF THE INVENTION 
       [0012]    The present disclosed invention eliminates the above described open procedures, reduces operating time, and allows for a consistent and repeatable fistula creation. 
         [0013]    It is well known that heat, whether its source is Radio Frequency (RF), resistance, or laser, will attach and weld tissue or vessels upon direct pressure and contact over the targeted weld area. This is often done with jaw-type, compression heat delivery devices. It is also well known that radially expandable devices such as balloons, metal cages, and baskets are often coupled with energy in the form of RF, or in the case of balloons, heated saline, and used intraluminally to ablate tissue, stop bleeding, or create a stricture. 
         [0014]    The present invention uses catheter based devices that are advanced from one vessel into an adjacent vessel (i.e. a vein into an artery), join the vessel walls by applying heat, and cut through the two walls, creating an anastomosis. 
         [0015]    The inventive catheter-based devices track over a guidewire which has been placed from a first vessel, such as a vein, into a second vessel, such as an artery, or more broadly between any other two vascular structures. The distal tip of the catheter has a dilating tip which allows the catheter to advance easily through the vessel walls. Proximal to the distal tip, the catheter has a significant reduction in diameter, and then a blunt, oval shaped tapered surface. As the catheter is tracked over the guidewire, the tapered distal tip easily passes into the adjacent vessel. As the catheter is further advanced, the blunt proximal surface comes into contact with the wall of the first vessel and encounters resistance, and cannot perforate through the wall into the second vessel. The distal tip, which has a matching blunt surface on its proximal end, is then retracted, capturing the walls of the two vessels between the two blunt surfaces. A known, controlled pressure (approximately 100 mN/mm 2 -300 mN/mm 2 ) is applied between the two surfaces. The pressure can be controlled either internally in the catheter or by the handle attached to the proximal end of the catheter. Heat is then applied to the blunt surfaces to weld the walls of the two vessels together. It is possible to only apply the heat to one surface as well. Heat can be applied through several different methods, including, but not limited to, radiofrequency, resistance, inductance, or a combination thereof. The heat is controlled at a known temperature ranging from between about 100-150 C. The heat may be applied by either applying a steady heat, pulsing heat, or a combination thereof. 
         [0016]    After coaptation of the vessel walls, the heat is then increased to cut through the vessel walls to create the desired size fistula. It should be noted that it is also possible to apply the same heat to both weld the vessel walls and to cut through the vessel. 
         [0017]    More particularly, there is provided a device for creating an arteriovenous (AV) fistula, which comprises an elongate member, a distal member connected to the elongate member and movable relative to the elongate member, and a heating member disposed on at least one of the movable distal member and the elongate member. The distal member comprises structure for capturing tissue to be cut to create the fistula, and the heating member is adapted to cut through the tissue to create the fistula. The elongate member comprises an elongate outer tube. 
         [0018]    A shaft connects the distal member to the elongate member, and is extendable and retractable to extend and retract the distal member relative to the elongate member. Preferably, the elongate member comprises a distal tapered face and the distal member comprises a proximal tapered face, wherein the distal tapered face and the proximal tapered face are substantially aligned to one another. In some embodiments, the heating member is disposed on the proximal tapered face, while in other embodiments, the heating member is disposed on the distal tapered face. Some embodiments further comprise a second heating member disposed on the distal tapered face. At least one of the heating member and the second heating member comprises an energized heater and a heat spreader disposed beneath the energized heater to spread heat away from the heater and create a temperature gradient. The heat spreader comprises heat conductive material, and is disposed on the tapered face beneath the heating member. 
         [0019]    Preferably, the distal member is tapered and flexible, so that it can push through a small aperture between the two vessels to be joined with a fistula. In some embodiments, the distal member comprises a toggle member which is pivotal relative to the elongate member. In certain embodiments, a shaft is provided for connecting the toggle member to the elongate member, the shaft being extendable and retractable to extend and retract the toggle member relative to the elongate member, wherein the toggle member is pivotally connected to the shaft. 
         [0020]    In one disclosed embodiment, the distal member comprises a flexible clamp to which is connected a heater, wherein the clamp is movable relative to the elongate member and is adapted to capture tissue to be cut to create the fistula. In this embodiment, the distal member further comprises a distal portion connected to a distal end of the elongate member, the distal portion having a side port therein through which the flexible clamp and connected heater extend. 
         [0021]    A tissue receiving cavity may be associated with the heating member, to capture cut tissue. As noted above, in some embodiments, the heating member comprises an energized heater and a heat spreader disposed beneath the energized heater to spread heat away from the heater and create a temperature gradient. The heat spreader comprises heat conductive material. 
         [0022]    In another aspect of the invention, there is disclosed a method of creating an AV fistula between adjacent first and second vessels, which comprises a step of inserting a guidewire from the first vessel into the second vessel, inserting a catheter comprising a proximal elongate member and a distal member over the guidewire, so that a tapered distal tip of the distal member comes into contact with a selected anastomosis site, and advancing the distal member into the second vessel, while the elongate member remains in the first vessel, thereby enlarging an aperture between the two vessels. A further step involves retracting the distal member toward the elongate member to clamp tissue surrounding the aperture between opposed surfaces on each of the distal member and the elongate member, and applying energy to a heating member on one of the distal member and the elongate member to cut and form the aperture, and to weld the edges thereof in order to create a desired fistula between the two vessels. 
         [0023]    Preferably, the opposed surfaces on each of the distal member and the elongate member comprise aligned tapered faces, between which the tissue is clamped, wherein a heating member is disposed on at least one of the two aligned tapered faces. The method may advantageously further comprise a step of capturing cut tissue within a cavity disposed adjacent to the heating member. Heat may be dispersed away from the heating member using a heat spreader comprising a conductive material disposed on the tapered face beneath the heating member. 
         [0024]    The invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying illustrative drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]      FIG. 1  is an isometric view of an embodiment of a catheter device constructed in accordance with the principles of the present invention; 
           [0026]      FIGS. 2-8  are schematic sequential views illustrating a method for creating a fistula performed in accordance with the principles of the present invention, and using an apparatus like that illustrated in  FIG. 1  and disclosed herein; 
           [0027]      FIG. 9  is a schematic view illustrating an elongate aperture formed between two adjacent vessels to create the fistula, particularly highlighting the welded edges of the aperture; 
           [0028]      FIG. 10  is a cross-sectional view of a handle portion of the embodiment shown in  FIG. 1 ; 
           [0029]      FIG. 11  is an isometric view similar to  FIG. 1 , illustrating an alternative embodiment of the invention; 
           [0030]      FIG. 12  is an isometric view of yet another alternative embodiment of the present invention; 
           [0031]      FIG. 13  is an isometric view of still another alternative embodiment of the present invention, wherein a distal toggle member forming part of the device is extended; 
           [0032]      FIG. 14  is an isometric view similar to  FIG. 13 , wherein the distal toggle member is retracted; 
           [0033]      FIG. 15  is an isometric view of yet another alternative embodiment of the present invention; and 
           [0034]      FIGS. 16-18  are schematic sequential views illustrating a method for creating a fistula using the apparatus of  FIG. 15 . 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0035]    Referring now particularly to the drawings, there is shown in  FIG. 1  a bi-polar tapered tip catheter embodiment  10 , which comprises an elongate outer tube  12  having an outer diameter that can range from 3 F-12 F. It may be manufactured from a variety of materials, either polymer or metallic. It comprises a central lumen  14 , within which a tubular structure  16  for attaching a tip  18  may slide. There are separate lumina that run down the elongated core of the outer tube  12  for wiring to power electrodes or heating elements  20 ,  22  (proximal and distal, respectively), disposed on aligned tapered faces of the respective elongate outer tube  12  and distal tip  18 , and to also measure the temperature during the coaptation and cutting processes. In this configuration, the catheter is powered using bipolar energy to the distal RF electrode  22  and the proximal RF electrode  20 . The system can also be used in a monopolar configuration by grounding the patient and applying energy to one or both of the RF electrodes to increase the length of the coaptation. The RF electrodes cut at matching angles to increase the surface area of the coaptation and fistula size relative to the catheter diameter. These angles can be adjusted to achieve the desired fistula sizing. The RF electrodes are only electrically conductive on the front faces to maximize energy density. The electrodes are oval-shaped, and are adapted to cut an anastomosis which is larger than the diameter of the shaft  16 . 
         [0036]    The apparatus shown and described above in connection with  FIG. 1  will now be further described in conjunction with an explanation of a particular method by which the system  10  may be used to create an AV fistula. This method is illustrated more particularly in  FIGS. 2-9 . 
         [0037]    To begin the inventive method of creating an AV fistula, the practitioner selects an appropriate procedural site having each of a first vessel  26  and a second vessel  28  in close proximity to one another. In currently preferred approaches, the first vessel  26  comprises a vein, and the second vessel  28  comprises an artery, but the invention is not necessarily limited to this arrangement. As illustrated in  FIG. 2 , one presently preferred location is the hand  30  of a patient. Then, generally employing principles of the Seldinger technique, as shown in  FIG. 2 , the first vessel  26  is punctured by a needle  32 , which is inserted therein, for the purpose of introducing an access sheath into the site. Then, using suitable techniques, such as the technique described in Provisional U.S. Application Ser. No. 61/354,903, filed on Jun. 15, 2010 and herein expressly incorporated by reference, in its entirety, a guidewire  34  is inserted into the patient, from the first vessel  26  into the second vessel  28 , as shown in  FIG. 3 . 
         [0038]    The guidewire  34  creates an access path for the catheter  10 . The catheter  10  is inserted into the patient by loading a proximal end of the guidewire  34  into the tip  18 , which is fabricated to be flexible and tapered. The catheter  10  is advanced further into the patient, tracking over the guidewire  34 , until the tapered dilating distal tip  18  comes into contact with the selected anastomosis site. The device  10  can be tracked over the guidewire with the distal tip extended (as shown in  FIG. 5 ) or retracted (as shown in  FIG. 4 ). The distal tip  18  is extended and further advanced into the second vessel  28  ( FIG. 5 ) by advancing the central tubular structure  16  distally from the outer tube  12 , thereby dilating the fistula, so that the distal tip  18  is in the second vessel  28 , and the tube  12  is in the first vessel  26 , with its distal tapered surface contacting the inner wall of the first vessel  26 . If resistance is felt, the entire system can be rotated to reduce the friction. At this juncture, the opening formed in the wall of the second vessel  28  has recovered back to a small diameter, and fits tightly around the shaft  16 , as shown. 
         [0039]    After the distal tip  18  is advanced into the second vessel  28 , as illustrated in  FIG. 6 , a slight tension is applied to the distal RF electrode  22  to seat it against the vessel wall. The blunt shape of the proximal end of the distal tip  18  prevents the distal tip from pulling back through the vessel wall. The proximal end of the device  10 , namely the outer tube  12 , is then advanced to close the spacing between the tube  12  and tip  18 , until the walls of the first and second vessels  26 ,  28 , respectively, are captured between the facing blunt surfaces of each of the outer tube  12  and distal tip  18 . 
         [0040]    A controlled tension is maintained between the distal tip  18  and proximal outer tube  12 , and at this juncture, with the vessel walls securely clamped, energy is applied to the RF electrodes  20 ,  22  ( FIG. 7 ). As the electrodes weld and cut the vessels, the electrodes will move closer to one another. When fully retracted, the system  10  is designed so that the two electrodes  20 ,  22  cannot come into direct contact with one another, thus preventing the electrodes from shorting. A variety of RF energy profiles may be applied to achieve the desired coaptation and cutting. For example, during the coaptation phase, a tapered sine wave may be applied to maximize coagulation without cutting through the tissue. The energy may also be adjusted based upon the impedance of the tissue. Different pulse widths or duty cycles may be used to minimize the heat transferring into adjacent tissues. The hot wire is an oval shape and cuts an anastomosis larger than the diameter of the shaft  16 . Within the oval shape of the cutting elements, there is a cavity for capturing the tissue that has been cut. The outer sliding tube is usable to push the tissue off the heater in case there is a sticking problem due to the heat. 
         [0041]    Regarding the tissue welding process, more particularly, the RF energy functions to burn and fuse or weld the vessels together, creating an elongate aperture  36  ( FIG. 8 ) through the opposing walls of each of the first and second vessels, as well as any intervening tissue. As formed, the elongate aperture  36  will typically resemble a slit. However, as pressurized flow  38  begins to occur through the slit or aperture  36 , which creates a communicating passage between the first vessel and the second vessel, the aperture widens responsive to the pressure, taking the shape of an ellipse as it opens to form the desired fistula. This effect is illustrated in  FIG. 9 . The edges  40  of the aperture are cauterized and welded.  FIG. 9  illustrates the weld from the venous (first vessel) side. As shown, the cut area corresponds to the shape of the heater wire. It can be of multiple shapes, such as round, oval, a slit, or a combination as shown. The area outside of the cut has been welded due to the flat face of the catheter in the vein (first vessel) being larger than the cutting wire. The heat from the wire is also preferably spread over this area by a conductive material that is below the heater, as will be described below. This creates a temperature gradient, which is a particularly advantageous feature of the present invention. 
         [0042]    Tissue welding of the type intended to occur in the practice of these inventive methods is discussed in U.S. Pat. No. 6,908,463, to Treat et al., which is herein expressly incorporated by reference, in its entirety. 
         [0043]      FIG. 10  is a cross-sectional view of a handle portion  42  of the embodiment shown in  FIG. 1 . This is one possible approach for actuating the extension and retraction of the distal tip  18  relative to the elongate outer tube  12 , as discussed above, though many other suitable configurations may be used alternatively. A trigger  44  is slidably disposed on the handle  42 , slidable distally through a slot  46  in the direction of arrow  48 , and then retractable in the reverse direction. A spring  50  within the handle controls pressure, and a locking mechanism functions to lock the trigger  44  in the retracted state. 
         [0044]    Alternative cutting approaches, such as resistive heat (hot wire), ultrasonic, laser, or mechanical approaches, may be used instead of RF energy, if desired. For example,  FIG. 11  illustrates an alternative embodiment, wherein a catheter  110  comprises an elongate outer tube  112  having a central lumen  114 , a tubular structure  116 , and a flexible and tapered distal tip  118 . In this embodiment, a single resistive heating wire  152  is used to provide the tissue heating, cutting, and welding function described above. Additionally, an RF configuration applying only monopolar energy, to either the venous or arterial sides, may be employed. A combination of RF energy and resistance heating may also be used. The tip  118 , in this embodiment, tracks over the guidewire and dilates the anastomosis site, as in the previous embodiment. The tapered faces of the members  112  and  118  align. The single hot wire  152  down the face cuts a slit in the vessel walls, and the faces are tapered to assist in removing the device. 
         [0045]    Now with reference to  FIG. 12 , a heat spread catheter  210  is illustrated. The catheter  210  comprises a resistive heating element  252 , which is employed in a manner similar to that described above in connection with the  FIG. 11  embodiment. However, in this embodiment, a conductive material  254  is disposed beneath the heating element  252 . In one configuration, this conductive material  254  comprises aluminum, though other conductive bio-compatible materials may also be used. In operation, this conductive material  254  functions to create a heat gradient from the heating element  252 , for the purpose of improving the welding function, as described above. 
         [0046]    In this embodiment, similar to the foregoing embodiments, the tip  218  tracks over the guidewire and dilates the anastomosis site. The tapered faces of each of the members  212  and  218  align, for clamping the vessel walls. The hot wire  252  is an oval shape and has vertical strips  256  on both sides of the artery. The hot wire cuts an anastomosis larger than the diameter of the shaft  216 . Under the hot wire  252 , the heat conductive material  254  pulls heat away from the hot wire so that there is a temperature gradient across the face, with the temperature being hottest in the center and cooling as the distance outwardly from the center increases. 
         [0047]    The hot wire  252  (heater) is raised above the spreader  254  to increase pressure on the tissue, to thereby assist in the cutting process. Inside the hot wire, there is a cavity to capture the tissue that has been cut. The profile of the distal tip  218  aligns with the edge of the heater when retracted. It is a lower profile than the heat spreader, so that it can be retracted back through the fistula. This also increases the pressure directly on the heater surface to assist in cutting function. 
         [0048]      FIGS. 13 and 14  illustrate still another embodiment  310 , comprising a distal toggle member  358 . The cutting elements in this embodiment are substantially identical to those shown and described in connection with  FIG. 12 . As in prior embodiments, the toggle  358  tracks over the guidewire into the artery. When retracted ( FIG. 15 ), the toggle captures the artery and pulls against the vein. The hot wire is an oval shape, has vertical strips  356  on both sides of the artery, and cuts an anastomosis larger than the diameter of the shaft  316 . Under the hot wire  352 , there is a heat conductive material  356  that pulls heat away from the hot wire so that there is a temperature gradient across the face. The hot wire is raised above the heat spreader to increase pressure on the tissue to help it cut through. Inside the hot wire there is a cavity to capture the tissue that has been cut. 
         [0049]    The profile of the toggle  358  aligns with the edge of the heater when retracted. It is of a lower profile than the heat spreader so that it can be retracted back through the fistula. This also increases the pressure directly on the heater surface and helps it cut. Heating elements may also be disposed on the toggle surface to work in conjunction with the heater  352  to cut and weld tissue. 
         [0050]    Pivotable toggles and their functionality are discussed in Provisional U.S. Application Ser. No. 61/354,903, filed on Jun. 15, 2010 and already herein expressly incorporated by reference. Those teachings generally apply to this toggle embodiment, regarding the particulars as to how the toggle is used to enter and then retract the second vessel toward the first vessel. 
         [0051]    In  FIGS. 15-18 , there is shown a different cutting approach. In this embodiment, the cutting device  410  comprises a shaft  460  having a distal portion  462 . The distal portion comprises a side port  464 , from which extends a heater wire  466  which is supported by a flexible clamp  468 , preferably fabricated from nitinol or similar material. The heater wire may be resistive or utilise any other energy source as described above. 
         [0052]    As shown in  FIGS. 16-18 , access to the anastomosis site is gained by methods as described above and the function of this device, once in place, is to manipulate the wire  466 , using the flexible clamp  468  and suitable actuation mechanisms in order to create a fistula of a desired configuration. Specifically, as shown in  FIG. 16 , the tip  462  tracks over the guidewire  34  and dilates the anastomosis site, as in previously described approaches. The catheter  410  is advanced so that the clip  466  is all the way in the artery  28 , and then puled back to capture the arterial wall under the clip, as illustrated in  FIG. 17 . The wire is then activated to heat, and then drawn back, which cuts through the arterial and venous walls. The hot wire is then pulled back ( FIG. 18 ), and pulls down the clip portion through the vessel walls. 
         [0053]    Accordingly, although an exemplary embodiment and method according to the invention have been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention.