JP2001513000A - Methods and systems for establishing vascular access - Google Patents

Abstract

(57) Summary The body lumen access system (10) has a distal access cannula (12) and a proximal access cannula (14). A distal access cannula (12) is attached to or within the body lumen, and a proximal access cannula (14) is attached to the implantation port (24) or a luer or other external Percutaneously positioned and attached to coupler (16). These distal and proximal access cannulas are usually implanted separately, cut to length, and attached to the subcutaneous junction. Preferably, the proximal access cannula (12) has a larger lumen diameter than the distal access cannula (12) to reduce flow resistance in these cannula systems. In some cases, the distal and proximal access cannulas may be integrally formed.

Description

Description: METHODS AND SYSTEMS FOR Establishing Vascular Access Background of the Invention This application is a continuation-in-part of US Provisional Patent Application No. 60 / 036,124, filed January 21, 1997, The full disclosure of which is incorporated herein by reference. 1. Field of the invention The present invention relates generally to the design and use of medical devices, and more particularly to methods and systems for establishing temporary access to a patient's vasculature for hemodialysis and other extracorporeal blood treatments. Access to the patient's vasculature can be established with a variety of temporary and permanent implantation devices. Most simply, temporary access can be obtained by direct percutaneous introduction of a needle through the patient's skin and into a blood vessel. While such direct access is relatively simple and suitable for time-limited applications (e.g., intravenous nutrition, intravenous drug delivery, etc.), they are It is not appropriate for dialysis and other extracorporeal blood treatments, which must often be repeated periodically throughout the life of the patient. For hemodialysis and other extracorporeal treatment regimes, various percutaneous catheters and implantable ports have been proposed over the years. Percutaneous catheters (e.g., Tesio catheters available from Med Comp and Perm-Cath® available from Quinton) have a proximal end extending through the skin and the distal end that is placed in a vein in an endogenous fashion Consists of a single catheter or the like having a terminus and is available for connection to hemodialysis or other blood treatment systems. Such catheters include a DACRON® cuff placed directly under the skin to reduce the risk of infection. The implantable port, in contrast, is completely subcutaneous and is connected to a vein or artery by a subcutaneous cannula. Access to this port is achieved by percutaneous placement of a needle or other connecting tube. Such ports typically have a needle penetrable septum to allow percutaneous penetration of the needle. More recently, port designs with several valves have been proposed, in which the introduction of a needle or other access tube opens the valve and provides a flow path to the cannula that connects to the blood vessel. Both the percutaneous and implanted port vascular access systems have certain disadvantages and limitations. For example, both such access systems only allow for limited blood flow rates. In the case of percutaneous catheters, the limited flow rate is due to the generally small lumen diameter available with indwelling venous catheters. In the case of an implanted port access system, the limited flow rate is due to both the port configuration and the relatively small lumen diameter available in the cannula connecting the port to the vessel. Such limited blood flow rates are problematic because they extend the duration of the associated extracorporeal blood treatment protocols (eg, hemodialysis, hemofiltration and apheresis). Initial implantation of both this percutaneous and implanted port vascular access system is also problematic. Such systems generally have a single catheter or cannula connected to or implanted in a blood vessel to an external attachment point (ie, either an implantation port or a percutaneous passage through the skin). Subcutaneous placement of this catheter or cannula is difficult in many respects. For example, catheters and cannulas with their distal ends implanted in the jugular vein are typically 90 ° -180 ° so that their associated ports or catheter outlets are placed in place on the patient's chest. Bend at an angle. Such bending can also accommodate excessive lengths of the connecting catheter and cannula. However, this bending is also subject to torsion or other problems. It is therefore desirable to provide a method and system for implanting a vascular access catheter and cannula that can be adapted to different characteristics and placement patterns of a patient. An even more significant problem with conventional percutaneous and implanted port vascular access systems is replacement. Percutaneous catheters often need to be replaced when their distal end fails due to obstruction or other causes. Until now, it was usually necessary to remove the entire catheter, including the percutaneous cuff that had in-grown the tissue. In the case of an implanted port system, either this port or the cannula attached to the vessel may fail. Until now, it has generally been necessary to remove both this port and the implant cannula when replacing either. Accordingly, it is desirable to provide an improved method and system that allows replacement of only a portion of the implanted system when other portions are functioning. For these reasons, it is desirable to provide improved percutaneous and implantable port access systems and methods for their implantation and replacement that overcome at least some of the above problems. In particular, the vascular access system has a high flow rate (preferably at least above 200 ml / min, even more preferably above 500 ml / min, even more preferably above 600 ml / min, even more preferably above 700 ml / min. If it can be given. The systems and methods of the present invention should also facilitate both initial implantation and, if necessary, subsequent replacement of system components while minimizing trauma to the patient. At least some of these objectives will be met by different aspects of the application described below. 2. Description of the prior art U.S. Patent Nos. 5,562,617 and 5,041,098 are representative of an implantable system using a cannula extending between a port and a blood vessel to provide extracorporeal circulation. U.S. Pat. Nos. 5,417,656 and 5,281,199 show an implantable port connected to a vascular cannula via a transition region (FIG. 1A) or to multiple branch cannulas (FIG. 21). U.S. Pat. No. 4,892,518 shows an implantation port with a transition region extending into a cannula. U.S. Pat. Nos. 5,234,406 and 5,215,530 show a two-part catheter having a distal portion that can be placed percutaneously. The '406 patent discloses a large diameter proximal portion for increasing the flow of anesthetic into the subarachnoid region of the spine. U.S. Patent Nos. 5,203,771 and 4,181,132 show implantable connectors that provide percutaneous access to an implantation shunt. Applications pending at the time of filing the application and assigned to the assignee of the present application include U.S. Patent Application Nos. 08 / 745,903; 08 / 724,948; 08 / 634,634; 08 / 539,105; and 60 / No. 036,124. The full disclosures of each of these U.S. patents and applications pending at the time of filing the present application are incorporated herein by reference. SUMMARY OF THE INVENTION The present invention provides improved methods and systems for accessing lumens (particularly abdominal cavities as well as blood vessels). These systems include an access cannula (which typically includes a distal portion and a proximal portion), which extends from a body lumen to a proximal access site (typically an implantation port or transdermal port). (Skin access position catheter). Distal access to body lumens is provided by various access devices and modalities (eg, indwelling cannulas, cross tubes (T-catheter), end-to-side anastomosis, etc.). The method and system of the present invention, in addition to facilitating the initial implantation of the access cannula system, also simplifies replacement of all or a portion of the access cannula system (if such replacement is required). Particularly useful. This access cannula design also minimizes flow resistance and allows the system to be used in high volume extracorporeal treatment protocols (e.g., flow rates greater than 200 ml / min, typically greater than 500 ml / min, often 600 ml / min). (Sometimes more than 700 ml / min). According to a first aspect of the method of the present invention, access to the patient's body lumen is established by implanting a distal access cannula between the body lumen and the subcutaneous junction. A proximal access cannula is implanted between the subcutaneous junction site and a catheter connection site located at a site remote from the body lumen. The length of at least one of the distal and proximal access cannulas is then the appropriate overall length between the body lumen and the remote access site (i.e., neither too long nor too short). (Preferably both are adjusted, for example, by cleavage). The proximal end of the distal access cannula is then connected to the distal end of the proximal access cannula, typically using a coupler positioned therebetween. The location of this subcutaneous junction may be virtually anywhere between the body lumen and the remote access site, and need not be on a straight path between them. Often, the access cannula follows an arched or U-shaped path between the body lumen and the access site, and the subcutaneous junction may be anywhere along such a path. . In some cases, the subcutaneous junction is placed or formed adjacent to a body lumen (e.g., within 0-5 cm) to reduce the number of incisions needed to implant the entire system. You may. By locating the junction area adjacent to the body lumen, the distal access cannula is connected to the body lumen, typically using a coupler described in more detail below, and to the distal end. To connect the proximal end of the proximal access cannula to the distal end of the proximal access cannula, only a single incision and cavity need be made. However, in other cases, it is desirable to position the subcutaneous junction away from the body lumen (typically 5 cm to 50 cm from the body lumen). This subcutaneous junction is usually not adjacent to the implantation port. The adjusting step preferably includes adjusting the length of both the distal and proximal access cannula. Adjustment typically involves cutting off the end of the cannula located at the subcutaneous junction. The cannula may be cut before implantation (in which case it must be precisely sized before implantation), but more commonly it is cut after partial implantation, The cut end is then temporarily placed at this subcutaneous junction. The step of implanting the distal access cannula involves attaching the distal end of the distal access cannula to a body lumen in a manner. For example, the distal access cannula can be in the form of an indwelling venous catheter, where the distal end is typically at least 1 cm, usually 5 cm or more, either by incision or injection penetration. At a distance, it is introduced into the vessel wall. Alternatively, the distal end of the distal access cannula may be in the form of a cross-tube (T-catheter), which is disclosed in U.S. Patent Application Nos. 08 / 539,105 and 08 / 724,948, pending at the time of filing this application. (The full disclosures of which are incorporated herein by reference) are implanted at the vessel wall by incision as described. As a further alternative, the distal end of the distal access cannula may be as described in U.S. Pat.No. 5,562,617, the complete disclosure of which is incorporated herein by reference. Alternatively, it may be sutured to the vessel wall via an end-to-side anastomosis. This proximal access cannula implantation step can also include a number of access means. For example, the proximal access cannula may be placed percutaneously such that its proximal end is permanently outside the patient's body. This proximal end then has a standard luer or other fitting to connect with an external catheter for extracorporeal circulation or other purposes. This step of implanting the proximal access cannula may alternatively involve implanting the port connected to the proximal end of the cannula subcutaneously. This port is adapted to receive a percutaneous needle or other access tube for connection with an external catheter for extracorporeal circulation or other purposes. Although the medical and patent literature describes a large number of common subcutaneous ports, the present invention relates to U.S. Patent Application No. 60 / 036,124, which is pending at the time of filing this application, the complete disclosure of which is hereby incorporated by reference. This application is hereby incorporated by reference and is hereby incorporated by reference in its entirety, which application is particularly suitable for use with high volume needle actuation ports. The distal and proximal access cannulas typically have equal diameters in the range of 1 mm to 10 mm, usually in the range of 3 mm to 10 mm, and have substantially equal lumen cross-sections. , But often have different cross-sectional areas. As will be described in further detail in connection with the second aspect of the method of the present invention, at least a portion of the proximal access cannula, and the need to reduce the overall flow resistance created by the access cannula system Depending on the size of the proximal end of the distal access cannula, it is often desirable to have a larger cross-sectional area. The connecting step of the method of establishing body lumen access typically includes a first mounting opening for attaching a proximal end of the distal access cannula and a connecting opening for connecting a distal end of the proximal access cannula. Providing an intermediate coupler having a second mounting opening. The distal end of each of the distal and proximal access cannulas can be directly connected (eg, a coupler can be mounted on one or both of them), but an intermediate connection to which a “bare” tube can be attached Preferably, a vessel is provided. In this way, these access cannulas can be cut to their desired length, and the resulting "bare" cut end is typically placed over the end of the coupler to place a suture or other filament. And is attached to this intermediate connector in a convenient manner. These intermediate couplers can be linear (ie, with a straight lumen) such that the distal and proximal access cannulas are coaxially aligned at the point of attachment. Alternatively, these couplers may be used to position the distal and proximal access cannulas in a non-linear manner, e.g., by opening their first and second mounting openings between 45 ° and 270 ° (preferably between 90 ° and 180 °) and may be non-linear. In a particularly preferred aspect of the invention, these remote couplers can be adapted to connect a large diameter proximal access cannula to a small diameter distal access cannula. In some cases, the coupler itself may alter the diameter of the lumen connecting these two cannulas, but such a change is not necessary and the change in diameter In one of the cannulas (preferably this distal access cannula), it can be attached. Such a coupler is particularly useful for providing the low flow resistance access cannula described above. According to a second aspect of the method of the present invention, access between the body lumen and the implantation port is provided by a subcutaneous access cannula having a lumen therethrough. The improved low flow resistance access is achieved by implanting a cannula having an enlarged lumen in a region proximal to the point of entry of the body lumen and / or a region thereof distal to the point of penetration of the body lumen. Is obtained by Typically, for intravenous access, the cannula lumen has an inner diameter in the range of 1 mm to 6 mm at the point of penetration and / or distally of the body lumen wall. By setting the (inner) diameter of the cannula lumen in the range of 3 mm to 6 mm in the region proximal to the point of penetration of the body lumen, significantly lower flow resistance can be achieved. In a third aspect of the method of the present invention, access to the body lumen of the patient is established by providing an access cannula having a small diameter distal region and a large diameter proximal region. The access catheter is such that the small diameter distal region is connected to or within a body lumen and the distal end of the large diameter proximal region is located subcutaneously (typically as described above). (But not necessarily at the subcutaneous junction area). The proximal end of the access cannula can be used to connect to an external catheter by any of the methods described above. The small diameter distal region and / or the large diameter proximal region may have uniform or different diameters along their entire length. The diameter of each region is typically uniform, but in some cases it is desirable to increase the diameter in the proximal direction, where the increase may be tapered, stepped or irregular. possible. In the case of a two (or more) part access catheter, this small diameter distal region often corresponds to the distal access cannula. Alternatively, the distal access cannula can itself include the small diameter distal region and expand into the large diameter proximal region, but the proximal access cannula also has a large diameter after its subcutaneous connection. Has a diameter. In a fourth aspect of the method of the present invention, the implant cannula systems can be replaced by separately removing either their distal or proximal portions. The method includes surgically exposing a portion of the access cannula while leaving the distal end (which is attached to the body lumen) and at least one of the proximal portions unexposed. Include. The access cannula is disconnected (typically by removing one end from the remote connector) at the exposed site, and then the distal end and one of the proximal portion are connected to the other. Replace while in the proper position. This replacement part is then connected to the previously implanted part to re-establish access. Typically, when it is desired to replace the distal portion, the entire distal end of the cannula is exposed. Alternatively, when it is desired to replace the proximal portion, the entire proximal portion of the cannula is exposed. Alternatively, when replacing the proximal portion that is connected to the implantation port at its proximal end, it is necessary to surgically expose the port and the distal end of the proximal portion while leaving the intermediate portion subcutaneously implanted. There is only. The present invention further provides a system for establishing access to a body lumen of a patient. The system has a distal access cannula having a distal end, a proximal end and a lumen therethrough. The distal end of the distal access cannula is adapted for connection to a body lumen by any of the means described above to provide fluid communication between the body lumen and the distal cannula lumen. . The system further has a proximal access cannula having a distal end, a proximal end, and a lumen therethrough. The proximal end of the proximal access cannula is adapted for connection to the external catheter to provide fluid communication between the catheter and the proximal cannula lumen. Such external connection can be by a percutaneous catheter, an implantation port, or any of a number of conventional means. The system further includes a subcutaneous implantable connector for connecting the proximal end of the distal catheter directly to the distal end of the proximal catheter. By "direct" is meant that the coupler provides a substantially unobstructed flow therethrough (eg, an unobstructed flow lumen). One of the goals of the system of the present invention is to reduce the flow resistance in the access cannula, thereby contraindicating the inclusion of a flow restriction or control in the coupling. The coupler preferably has a body having a first mounting opening, a second mounting opening and a non-blocking flow lumen therethrough. If desired, this first mounting opening can branch to a plurality of additional mounting openings so that a single proximal access cannula can connect to multiple distal access cannulas and vice versa. . The flow lumen through the body may be coaxial or parallel, but also wherein the first and second mounting openings have an angle therebetween (typically in the range of 45 ° to 270 °, preferably Can be bent or deflected to make a 90 ° to 180 ° range). If desired, the lumen passing through the coupler body can extend out in one or the other direction to vary from a smaller diameter at one end to a larger diameter at the other end, It may be tapered or stepped. The invention further comprises a kit comprising a system (eg, any of the above) including a distal access cannula and a proximal access cannula together with instructions for using the above method. The system and instructions are incorporated into a sterile or non-sterile package (eg, pouch, box, tray, etc.). The instructions may be printed on the package insert (separate sheet) and / or on the packaging. The kits of the present invention can further include any one of the system components packaged with instructions for using the components according to the method of the present invention (eg, replacement parts for components in a previously implanted system). BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an isometric view of a first embodiment of a body lumen access system constructed in accordance with the principles of the present invention, the system including an internal venous cannula, and a proximal access cannula attached thereto. And a coupler for connecting the proximal access cannula to the intrinsic venous cannula. FIG. 2 is a detailed view of the coupler of FIG. 1 shown in cross section. FIG. 3 is an isometric view of a second embodiment of a body lumen access system constructed in accordance with the principles of the present invention, the system including a distal access cannula having a cross-tube at its distal end, and an attachment thereto. An implantable port having a proximal access cannula and a coupler for connecting the distal access cannula to the proximal access cannula. FIG. 3A is a detailed view of the distal end of the distal access cannula of FIG. FIG. 4 is an isometric view of a third embodiment of a body lumen access system constructed in accordance with the principles of the present invention, the system having a distal end adapted for connection to a body lumen by anastomosis. A distal access cannula having the implantable port having a proximal access cannula attached thereto, and a coupler for connecting the distal access cannula to the proximal access cannula. FIG. 4A is a detailed view of the distal end of the distal access cannula of FIG. FIG. 5 is an isometric view of a fourth embodiment of a body lumen access system constructed in accordance with the principles of the present invention, the system comprising an intrinsic venous cannula, a percutaneous proximal access cannula, and an intravenous cannula. It has a coupler for connecting to the skin proximal access cannula. FIG. 6 illustrates a coupler having a 90 ° bend. FIG. 7 illustrates a coupler having a 180 ° bend. FIG. 8 illustrates an implantable port having an integrated proximal cannula and a distal access cannula, wherein both the proximal and distal cannulas have an integrated coupler thereon. FIG. 9 illustrates a one-piece access cannula having a small diameter distal end and a large diameter proximal end, wherein the proximal end of the proximal portion of the cannula is attached to an implantable port. Or it can be mounted. FIG. 10 illustrates a patient vasculature to which the implantable access system of the present invention can be connected. 11A and 11B illustrate subcutaneous implantation of the access system of FIG. 1 into the jugular vein of a patient. FIG. 12 illustrates the percutaneous placement of the access system of FIG. 5 in the jugular vein of a patient. FIG. 13 illustrates the use of the coupler of FIG. 6 to implant the access system of FIG. 1 into the jugular vein of a patient. FIG. 14 illustrates the implantation of the access system of FIG. 3 into a patient's arteries and veins. 15A and 15B illustrate the implantation of the access cannula of FIG. 9 into the jugular vein of a patient. FIG. 16 illustrates a kit of the invention having a body lumen access system with instructions for use (IFU) and a package. Description of one embodiment The present invention provides methods and devices that facilitate percutaneous access to a body lumen of a patient. Representative body lumens include blood vessels, abdominal cavity, and the like. This method is particularly useful for accessing blood vessels, including both arteries and veins. Although the following description is specifically directed to blood vessels, it will be understood that the present invention applies to all body lumens and cavities where selective percutaneous access is desired. For percutaneous access, the port is implanted subcutaneously, such that the pathway is below the skin surface of the patient (typically within 3-20 mm of the skin surface). An access tube can then be inserted percutaneously into the passage in the access port to provide a connection to the blood vessel through the access port. For percutaneous access, a catheter (usually defining the proximal access cannula of the present invention) is implanted through the patient's skin, and the proximal end of the catheter is used for connection to an external catheter. Have been adapted. In both cases, access can be provided for various purposes, including, generally, blood draw, extracorporeal treatment of the drawn blood, and / or returning the treated blood to the patient. Such extracorporeal blood treatment is most often hemodialysis, but can also be hemofiltration, hemodiafiltration, apheresis, and the like. In addition to extracorporeal therapy, the access ports of the present invention can be used to perfuse drugs, liquids and other substances directly into the patient's circulatory system for various purposes. The device according to the invention comprises an access cannula, which is usually a distal access cannula, which is connected to or implanted in a body lumen, and a separate proximal access cannula, which is Is connected to the implantation port or is placed percutaneously through the patient's skin), but is not necessarily so. The proximal end of the distal access cannula is connected or connectable to the distal end of the proximal access cannula at the subcutaneous junction area, typically by a connector. These cannulas typically consist of a polymeric tube extruded from a common biocompatible catheter material (eg, silicone rubber, polyurethane, etc.). The distal access cannula is typically unobtrusive, especially when all or a distal portion thereof is intended for implantation in a venous lumen. A typical distal catheter has a length in the range of 5 cm to 45 cm, usually in the range of 10 cm to 30 cm, an outer diameter in the range of 2 mm to 8 mm, usually in the range of 3 mm to 6 mm, and a range of 1 mm to 6 mm, usually Have a lumen diameter ranging from 2 mm to 5 mm. This proximal access cannula has a length in the range of 3 cm to 45 cm, typically in the range of 5 cm to 15 cm, an outer diameter in the range of 4 mm to 11 mm, usually an outer diameter in the range of 6 mm to 8 mm, and a range of 3 mm to 10 mm, usually It has a lumen diameter ranging from 5 mm to 7 mm. These access cannulas are typically tubes having a uniform diameter along their entire length, but may have tapered, stepped, or other diameter variations, as described above. The distal end of the proximal access cannula and the proximal end of the distal access cannula allow the cut end of the cannula to fit into a mounting opening on the remote coupling, as described in further detail below. In particular, if the cut ends have the same diameter and other properties, they are usually uniform over a length sufficient to allow cutting. As noted above, these access cannulas have at least a separate distal portion and a separate proximal portion, where the portions are separate and connectable by a coupler. In another aspect of the device of the present invention, the distal and proximal portions of these access cannulas are reduced in distal portion and diameter to reduce the overall flow resistance created by these access cannulas. Can be formed integrally with the enlarged proximal portion. The length of such a catheter can be adjusted by cutting at either its proximal or distal end, but the transition area when changing its diameter is generally integrally formed, and Not available for cutting. Referring to FIG. 1, an access system 10 according to the present invention connects a distal access cannula 12, a proximal access cannula 14, and a distal end 18 of the proximal access cannula to a proximal end 20 of the distal access cannula. And a coupler 16 adapted to Distal access cannula 12 is in the form of an indwelling venous catheter and includes a plurality of openings 22 near its distal end to enhance blood inflow and outflow through the cannula. The outer diameter of the venous access cannula 12 (at least over its distal portion and usually over its entire length) typically ranges from 2 mm to 8 mm, preferably from 3 mm to 6 mm, and , Its lumen diameter is in the range of 1 mm to 6 mm, preferably in the range of 2 mm to 5 mm. Implantable port 24 is secured to proximal end 19 of proximal access cannula 14. The port 24 can be integrally or removably secured to the distal end 19, both of which are disclosed in U.S. Patent Application Serial No. 60 / 036,124, which is pending at the time of filing the present application, the entire disclosure of which And the present application is a continuation-in-part of that application). Port 24 provides percutaneous access to access system 10 by a needle or other access tube, which is introduced through the patient's skin and into orifice 26 at the top of this port. . The implantation of the access system 10 is described in further detail below with reference to FIGS. 11A and 11B. The system 10 of FIG. 1, or any of the other systems and their individual components, can be packaged with instructions for use (IFU), as shown in FIG. A conventional package (which may be a pouch P or any other package (e.g., tray, box, tube, etc.)) includes the system 10, the different parts of which may be Are held in different isolated pockets 200, 202 and 204. Typically, system 10 is sterilized in this package, for example, by radiation or ethylene oxide, and the instructions are provided either on the package itself or on another printed sheet. The instructions set forth any of the aspects of the method of the invention described herein. Referring to FIG. 1A, the system 10 may be modified for use in peritoneal dialysis by replacing the distal access cannula 12 with a thin-wound catheter 13. The thin-wound catheter has a proximal end 15 adapted for connection to a connector 16 and a distal end 17 similar to the design of a conventional peritoneal dialysis catheter. The catheter 13 includes a cuff 19 that is implanted in the abdominal wall, the proximal end of which can be cut off for joining to the connector 16 in the same manner described below for vascular access. Referring to FIG. 2, coupler 16 includes a body 30, which is typically composed of a biocompatible metal or thermoplastic (eg, titanium). The coupler body 30 includes a first mounting opening 32 (which is typically relatively open to receive the distal end 20 of the distal access cannula 12 if the proximal end 20 is cut or cut prior to connection. And a large diameter connection opening 34 adapted to receive the distal end 18 of the proximal access cannula 14 (which may also be cut or cut prior to connection). I have. Each mounting opening 32 and 34 has conical portions 36 and 38, respectively, and reduced diameter regions 40 and 42, respectively, to facilitate mounting of the tubular ends of these access cannulas. In particular, these tubular ends, which are typically silicone rubber or other elastomeric material, push through this conical region into a reduced diameter region. The ends of these cannulas can then be tied to this reduced diameter region using a suture or other biocompatible material. Lumen 44 through coupler body 30 may have a uniform diameter (typically 1 mm to 10 mm) along its entire length, or may be tapered to connect to proximal access cannula 14 The diameter can be increased toward the larger mounting opening 34. Referring to FIG. 3, a second access system 50 constructed in accordance with the principles of the present invention generally includes a proximal access cannula 14 and a coupler 16 as described above in connection with the embodiment of FIG. The distal access cannula 52 generally includes an axial tubular body 54, which generally has the dimensions described above, but at its distal end, as best shown in FIG. Ends in tube 56. This cross tube is described in detail in U.S. Patent Application Nos. 08 / 539,105 and 08 / 724,948, which are pending at the time of filing the present application, the entire disclosures of which are incorporated herein by reference. In the form of a T-shaped catheter, as described in US Pat. The cross tube 56 is intended for implantation into the lumen of a blood vessel in a manner that minimizes invasion. Valve 58 is typically a slit valve, but is provided at the distal end of tube 54 to prevent blood flow into the lumen of tube 54 without differential pressure. Therefore, blood flow to this tube is prevented unless positive or negative pressure is applied to port 24 to cause blood inflow or outflow. A third access system 60 constructed in accordance with the principles of the present invention is shown in FIG. Access system 60 generally includes proximal access cannula 14 and coupler 16 as described above in connection with the embodiment of FIG. The distal access cannula 62 has a tubular member 64 terminating at its distal end at a suture cuff 66, as generally shown in FIG. 4A. A membrane 68 with a slit valve therein is provided to prevent flow into or out of the lumen of tube 64 without differential pressure. The suturing of the distal access cannula 64 to a blood vessel or other body lumen is described in U.S. Patent No. 5,562,617, the complete disclosure of which is incorporated herein by reference. A fourth access system 70 constructed in accordance with the principles of the present invention is shown in FIG. Access system 70 generally includes distal access cannula 12 and coupler 16 as described above in connection with the embodiment of FIG. Proximal access cannula 72 is intended for percutaneous placement through the patient's skin, as described in further detail below in connection with FIG. The proximal access cannula includes a distal end 74, which may be cut off for connection to the connector 16. The proximal access cannula 72 preferably includes a cuff 76, which is implanted beneath the patient's skin to prevent bacterial contamination through the cannula, as is commonly known for intravenous catheters. Is intended. At the proximal end of the access cannula 72, a standard luer or other coupler 78 is provided to allow connection to an external catheter. Coupling 16 provides a linear attachment of the distal access cannula to the proximal access cannula. In many cases, it is desirable to provide a non-linear connection to facilitate positioning of a remote access site relative to a body lumen access site. A coupler 80 that provides a 90 ° relative angle between the distal and proximal access cannula is shown in FIG. The coupler 80 has a bent tube 82 having a first mounting opening 84 and a second mounting opening 86. As shown, these attachment openings are the same, but they can easily be of different sizes intended for attachment to a larger proximal access cannula and a smaller distal access cannula. The second bent coupler 90 is shown in FIG. The coupler 90 is U-shaped and provides a 180 ° turn between the mounting opening 92 and the mounting opening 94. Again, the mounting openings 92 and 94 are shown as having the same size, but often are of different sizes intended for mounting different sized cannulas. The connector 90 also includes a web 96 that bridges the area between adjacent legs of the connector. The web 96 is intended to prevent tissue ingrowth around this connector, thereby facilitating removal (if needed). The web 96 also provides a relatively large target for surgeons attempting to access the coupler for replacement of any cannula, with or without replacing the coupler. Without such a connector, a surgeon attempting to access the subcutaneous junction area in which the connector is to be placed would require one of these cannulas (made of silicone material, which can be easily cut). There is a danger of cutting or damaging. A less preferred access system according to the present invention is shown in FIG. This system is disclosed in U.S. Patent Application Serial No. 60 / 036,124, which is pending at the time of filing the present application, the entire disclosure of which is incorporated herein by reference and which is a continuation-in-part of that application. Described. Implantable port 24 has an integrated proximal access cannula 100 with an integrated coupler 102 at its distal end. The distal access cannula 104 can be any of the above shapes, but includes an integral connector 106 at its proximal end, where the connectors 102 and 106 are intended to mate. . The assembly illustrated in FIG. 8 has many of the advantages described above (eg, the ability to provide a large lumen diameter at the proximal access cannula 100, and the ability to provide either a proximal access cannula (with port 24) or distal access cannula 104). Although it provides the ability to remove and replace separately), it lacks many of the other advantages described above. In particular, by providing the permanently secured connectors 102 and 106, it is not possible to cut off the cannula ends that need to be connected. Also, the integral connection of the proximal access cannula 100 to the port 24 prevents these two parts from being separately replaced. Referring to FIG. 9, a sixth access system 110 constructed in accordance with the principles of the present invention has a one-part access cannula 112 having a small diameter distal portion 114 and a large diameter proximal portion 116. The proximal end of the proximal portion 116 is connected to the implantable port 24, generally as described above, but can also be made as a percutaneous catheter. Although the distal portion 114 of the access cannula 112 is shown as an indwelling catheter, it can be made as any of the other distal access cannulas described above, including cross-tube and suture cuff shapes. Access system 110 has the advantages of the present invention with respect to low flow resistance, but is less preferred because it does not have the improved implantation and replacement capabilities described in more detail below. The body lumen access system is particularly suitable for establishing percutaneous access to one or more locations in a patient's vasculature (including both arterial and venous vasculature). is there. As shown in FIG. 10, the artery and venous vasculature of the patient P includes a jugular vein JV, a subclavian vein SV, a subclavian artery SA, and an aorta A in an area surrounding and in contact with the heart H. With particular reference to FIGS. 11A and 11B, implantation of the paired access cannula system of FIG. 1 into a jugular vein JV is described. Access cannula 10 can be implanted by either phlebotomy or the Seldinger technique. Phlebotomy will be described first. After the patient is properly prepared and anesthetized, a phlebotomy is performed at the desired site of the jugular vein JV (typically 5 cm to 10 cm above the junction of the superior vena cava SVC and the right atrium of the heart). The distal tip of the first distal access cannula 12 is then inserted into the incision in the vessel wall until it reaches the junction of the superior vena cava SVC and the right heart atrium, as shown in FIG. 11A. A second distal access cannula 12 is inserted into the same incision so that its distal tip is located approximately 4 cm above the distal tip of the first cannula, as shown in FIG. 11B. The positioning of the distal tip of the distal access cannula 12 is confirmed by X-ray. When using the Seldinger method, an introducer needle is penetrated through the venous wall at the desired insertion site. After aspiration to ensure correct placement, the syringe is removed from the needle and a guidewire is inserted through the needle and into the vein. The needle is then withdrawn from the guidewire and the skin puncture site is enlarged with a scalpel. Then, at a site approximately 3 mm away from the first site, a second guide needle and guidewire are introduced through the venous wall. The sheath / dilator is then introduced from each guidewire into the venous lumen, and the dilator and one of the guidewires are removed from one of the sheaths. After perfusing the distal access cannula with heparinized sarin, the distal tip is passed through the available sheath and into the venous lumen until the tip reaches the junction of the superior vena cava SVC and the right atrium of the heart. Introduce. A second access cannula 12 is introduced through the second sheath in a similar manner. The tips of the two distal access cannulas 12 are adjusted to be approximately 4 cm apart, this position being confirmed by X-ray. The location for each implantable port 24 is selected based on a number of criteria. While appropriate in the subclavian fossa, the actual site may vary depending on the characteristics of the patient. The implantable port 24 should be located in an anatomical area that provides good stability, does not impede patient movement, forms an anatomical area that creates pressure points, or does not interfere with clothing It is. Placement should allow for an appropriate amount of overlying skin tissue, with optimal tissue thickness in the range of 5 mm to 15 mm. When blood circulation is to occur through a single venous location, the placement of the two implantable catheters should be well spaced. After selecting this port implantation position, a subcutaneous pocket is formed by phlebotomy using a blunt incision. The pocket should be large enough to accommodate the port 24 and position the port away from the incision. After forming the pocket, a tunnel is formed between the pocket and the venous entry site using a tunneling device. The distal end 18 of the proximal access cannula 12 is then trimmed to terminate at this venous entry site with sufficient clearance for body movement and subcutaneous connection. The cut-out distal end of the proximal access cannula is then placed over the large mounting opening 34 of the coupler 16 and secured within the reduced diameter region 42 with a suture or other biocompatible filament. After cutting the proximal end 20 of the distal access cannula 12 to the appropriate length, the small mounting opening 32 of the coupler 16 is inserted into the cut end. The connector 16 is then secured to the distal access cannula using a suture or other biocompatible filament placed over the region 40. The corresponding port 24 should then ultimately be located in this subcutaneous pocket and its base should be secured to the underlying facia using a non-absorbable single filament suture It is. These incisions can then be cleaned and closed after verifying proper placement and connection of all system components. The final position is shown in FIG. 11B. The percutaneous catheter system 70 can be implanted in a similar manner into the jugular vein JV, as shown in FIG. The implantation of the distal access cannula 12 can be the same. The percutaneous proximal access cannula 72 is placed percutaneously, and generally connected to the connector 16 after severing, as described above, in a manner similar to that of a normal percutaneous catheter placement. To move forward. The use of the remote coupler 90 to connect the distal access cannula 12 and the proximal access cannula 14 of the system of FIG. 1 is illustrated in FIG. Coupling 90 facilitates reversing between distal and proximal access cannula 12. As shown in FIG. 13, the coupler 90 is located at a location remote from both the venous access site and the location of the implantable port 24. This generally requires either a larger incision or a third incision. In many cases, it is possible to position the connector 90 near the site of venous penetration to reduce the size and / or number of penetrations required. The placement of the cannula access system 50 of FIG. 3 at separate venous and arterial sites is shown in FIG. The cross-tube connector 56 of the first distal access cannula 54 may be located in the subclavian artery SA as illustrated by the connector 16 and the proximal access cannula 14 located on the right side of the patient. The second cross tube 56 can be introduced into the subclavian vein SV using the coupler 16, proximal access cannula 14, and implantable port 24 located on the left side of the patient. Circulation between the subclavian artery SA and the subclavian vein SV can then be established by a percutaneous connection to the implantable port 24. Implantation of the single-tube access cannula 110 of FIG. 9 is shown in FIGS. 15A and 15B. The distal portion of cannula 114 can be introduced into the jugular vein JV in a manner similar to that described in connection with FIGS. 11A and 11B. After placement of the implantable port 24, a path can be tunneled between this port location and the vein, as shown in FIG. 15B. The proximal portion 116 of the cannula 110 is then positioned subcutaneously between this port location and the vein, cut to length, and connected to these ports. While the above is a complete description of the preferred embodiment of the present invention, various alternatives, modifications and equivalents may be used. Therefore, the above description should not be taken as limiting the scope of the invention, which is defined by the appended claims.

────────────────────────────────────────────────── ─── Continuation of front page    (31) Priority claim number 08 / 942,990 (32) Priority Date October 2, 1997 (Oct. 2, 1997) (33) Priority country United States (US) (81) Designated countries EP (AT, BE, CH, DE, DK, ES, FI, FR, GB, GR, IE, IT, L U, MC, NL, PT, SE), OA (BF, BJ, CF) , CG, CI, CM, GA, GN, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, M W, SD, SZ, UG, ZW), EA (AM, AZ, BY) , KG, KZ, MD, RU, TJ, TM), AL, AM , AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CU, CZ, DE, DK, EE, E S, FI, GB, GE, GH, GM, GW, HU, ID , IL, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MD, M G, MK, MN, MW, MX, NO, NZ, PL, PT , RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, UA, UG, UZ, VN, Y U, ZW (72) Inventor Finch, Charles D.             United States Michigan 39056, chestnut             Tonton, Water Oaks Drive               112 (72) Inventor Beesard, Gerald             United States Texas 78731, Oh             Stin, Green Trails South               3905 (72) Inventor Buffalo, George W.             United States Colorado 80005-2723,             Arbada, West 78 Tea H             Wraith 12673

Claims (1)

[Claims]   1. A method for establishing access to a body lumen of a patient, the method comprising: Includes:   Implanting a distal access cannula between the body lumen and the subcutaneous junction; When;   A proximal access cannula is placed between the subcutaneous junction and the catheter connection Transplanting;   At least one of the distal access cannula and the proximal access cannula Adjusting the length of the;   At the subcutaneous junction, the proximal end of the distal access cannula is Connect with the distal end of the cannula.   2. The adjusting step includes the distal access cannula and the proximal access cannula. The method of claim 1, comprising adjusting both lengths of the neura.   3. Wherein said adjusting step comprises the step of the distal access cannula adjacent to the subcutaneous joint site 2. The method of claim 1, comprising truncating the ends of the compound.   4. After the distal access cannula implants the distal access cannula 4. The method of claim 3, wherein the cutting is performed.   5. The distal access cannula is cut prior to the implantation step. 3. The method according to 3.   6. 2. The method of claim 1, wherein the subcutaneous junction is immediately adjacent the body lumen. Method.   7. 7. The method of claim 6, wherein the subcutaneous junction is 0 cm to 5 cm from the body lumen. The described method.   8. 2. The method of claim 1, wherein the subcutaneous junction is between 5 cm and 50 cm from the body lumen. The method described.   9. The step of implanting the distal access cannula moves the distal end of the cannula into the body. 2. The method of claim 1, comprising introducing into the body lumen through a membrane.   Ten. The body lumen is a blood vessel and distal of the distal access cannula 10. The end is connected at the vessel wall by incision or needle penetration. The method described in.   11． A cross in which the distal end of the cannula is implanted by the incision 11. The method of claim 10, comprising a tube.   12． At least 1 cm of the distal end of the cannula may be 11. The method of claim 10, wherein the method is implanted to be placed within a vessel lumen.   13. The distal end of the cannula is brought into contact with the vessel wall by end-to-side anastomosis. 10. The method of claim 9, wherein the method is connected.   14. The step of implanting the proximal access cannula includes the step of: Includes transcutaneous passage to provide external access to the proximal end The method of claim 1.   15． The proximal end of the proximal access cannula is released to an external catheter 15. The method according to claim 14, comprising a coupler adapted for a possible connection.   16． The step of implanting the proximal access cannula connects to a proximal end of the cannula 2. The method of claim 1, comprising implanting the port subcutaneously.   17． Wherein the distal access cannula and the proximal access cannula are substantially The method of claim 1, wherein the methods have substantially equal lumen diameters.   18． 18. The method according to claim 17, wherein said lumen diameter ranges from 1 mm to 10 mm.   19. The distal access cannula includes at least the proximal access cannula The method of claim 1, wherein the method has a distal lumen diameter smaller than the lumen diameter of the lens.   20. The distal lumen diameter of the distal access cannula ranges from 1 mm to 6 mm And the lumen diameter of the proximal access cannula is in the range of 3 mm to 10 mm. 20. The method of claim 19, wherein   twenty one. The lumen diameter of the distal access cannula is 2. The method of claim 1, wherein the method is qualitatively uniform.   twenty two. The lumen diameter of the distal access cannula is greater than its distal region. 2. The method of claim 1, wherein the method is large in the proximal region.   twenty three. The connecting step comprises a first mounting opening, a second mounting opening and a tube therebetween. Providing a coupler having a lumen, the proximal end of the distal access cannula being Attaching to a first attachment opening; and a distal end of the proximal access cannula The method of claim 1, comprising attaching an end to the second mounting opening.   twenty four. The first and second mounting openings are arranged at a relative angle in the range of 45 ° to 270 ° 24. The method of claim 23, wherein   twenty five. 25. The method according to claim 24, wherein said relative angle ranges from 90 [deg.] To 180 [deg.].   26. The connector comprises a webbed angled tube that prevents tissue ingrowth. 25. The method of claim 24, comprising:   27. The method according to claim 23, wherein the first and second mounting openings are coaxially aligned. The described method.   28. An improved method of establishing access between a body lumen and an implantation port, said method comprising: The method includes the steps of: providing a cannula having a lumen therethrough at a point of penetration at a wall of the body lumen; This is a type that is placed under the skin between the patient and the skin. Implanting the catheter, wherein the lumen is connected to the body lumen entry point and the port. Is larger than the body penetration point.   29. The diameter of the cannula lumen at the point of penetration of the body lumen wall is in the range of 1 mm to 6 mm. The cannula tube at an area between the body lumen and the port 29. The method of claim 28, wherein the cavity diameter ranges from 3 mm to 10 mm.   30. A method for establishing access to a body lumen of a patient, the method comprising: Includes:   Providing an access cannula having a small diameter distal region and a large diameter proximal region That; and   The small diameter distal region is connected to the body lumen and the distal end of the large diameter proximal region is skinned. Implanting the access cannula, as located below, At this, the proximal end of the proximal region is available for connection to a catheter.   31. The lumen diameter of the distal region ranges from 1 mm to 6 mm; 31. The method of claim 30, wherein the lumen diameter of the zone is in the range of 3 mm to 10 mm.   32. The lumen diameter of the distal region of the access cannula extends over its entire length. 32. The method of claim 31, wherein the method is substantially uniform.   33. The luminal diameter of the proximal region of the access cannula extends over its entire length. 33. The method of claim 32, wherein the method is substantially uniform.   34. The step of implanting the access cannula removes a body membrane from the distal end of the cannula. 31. The method of claim 30, comprising introducing into the body lumen.   35. The body lumen is a blood vessel and the distal end of the distal access cannula 35.The end of claim 34, wherein the ends are connected at the vessel wall by incision or needle penetration. The described method.   36. A cross in which the distal end of the cannula is implanted by the incision 36. The method of claim 35, having a tube.   37. At least 1 cm of the distal end of the cannula may be 36. The method of claim 35, wherein the method is implanted to be placed in a vessel lumen.   38. The distal end of the access cannula is adapted for end-to-side anastomosis by 31. The method of claim 30, wherein the method is connected to a vessel wall.   39. The step of implanting the access cannula may include removing the proximal end of the cannula from the proximal end. Contraction, including percutaneous passage to provide external access to the distal end 31. The method according to claim 30.   40. The proximal end of the access cannula is releasable to an external catheter 40. The method of claim 39, comprising a coupler adapted for connection.   41. The access cannula implantation step is connected to a proximal end of the cannula. 40. The method of claim 39, comprising implanting the port subcutaneously.   42. The access cannula includes a distal portion and a proximal portion, and the implant A step connects the proximal end of the distal portion with the distal end of the proximal portion at a subcutaneous junction. 31. The method of claim 30, comprising connecting.   43. The distal portion and the distal region are coextensive and the proximal 43. The method of claim 42, wherein the portion and the proximal region are coextensive.   44. The distal portion has both the distal region and a port of the proximal portion 43. The method of claim 42.   45. 43.The method of claim 42, wherein the subcutaneous junction is immediately adjacent the body lumen. Method.   46. 46. The method of claim 45, wherein the subcutaneous junction is between 0 cm and 5 cm from the body lumen. The method described.   47. 43. The method of claim 42, wherein the subcutaneous junction is between 5 cm and 50 cm from the body lumen. The method described.   48. The connecting step comprises a first mounting opening, a second mounting opening and a tube therebetween. Providing a coupler having a lumen, the proximal end of the distal access cannula being Attaching to a first attachment opening; and a distal end of the proximal access cannula 43. The method of claim 42, comprising attaching an end to said second mounting opening.   49. The first and second mounting openings are arranged at a relative angle in the range of 45 ° to 270 ° 49. The method of claim 48, wherein   50. 50. The method of claim 49, wherein said relative angle ranges from 90 [deg.] To 180 [deg.].   51. The connector comprises a webbed angled tube that prevents tissue ingrowth. 50. The method of claim 49, comprising:   52. The method of claim 48, wherein the first and second mounting openings are coaxially aligned. The described method.   53. Further, prior to the connecting step, the distal portion of the access cannula and 43. adjusting the length of at least one of said proximal portion and said proximal portion. The described method.   54. The adjusting step includes the distal access cannula and the proximal access cannula. 54. The method of claim 53, comprising adjusting both lengths of the neura.   55. The adjusting step cuts off the end of the cannula adjacent the subcutaneous junction. 55. The method of claim 54, comprising disconnecting.   56. The method of claim 55, wherein the cannula is severed after implanting the cannula. The described method.   57. The method of claim 55, wherein the cannula is cut prior to the implantation step. Law.   58. A distal end attached to a body lumen and a proximally located distal end from the distal end An improved method of replacing a graft cannula having a portion, wherein the improvement comprises: , Including:   Leaving the distal end and at least one of the proximal portions unexposed, Surgically exposing a portion of the cannula;   Disconnect the cannula within the exposed portion to separate the distal end from the proximal portion. Release;   Take one of the distal end and the proximal portion, with the other in place. Replacing; and   Reconnecting the distal end and the proximal portion.   59. The surgical exposing step exposes the entire distal end of the cannula 59. The improved method of claim 58, wherein the distal end is replaced.   60. The surgical exposing step exposes the entire proximal portion of the cannula 59. The improved method of claim 58, wherein the proximal portion is replaced.   61. The surgical exposing step exposing an access port of the proximal portion 61. The method of claim 60, wherein the proximal portion and the access port are replaced. How to improve.   62. A system for establishing access to a body lumen of a patient, the system comprising: The system includes:   With a distal access cannula having a distal end, a proximal end and a lumen therethrough And wherein the distal end of the distal access cannula is in communication with the body lumen. Suitable for connection to the body lumen to provide fluid communication with the distal cannula lumen. Have been combined;   With a proximal access cannula having a distal end, a proximal end and a lumen therethrough And wherein the proximal end of the proximal access cannula is connected to an external catheter. Connection to the catheter to provide fluid communication with the proximal cannula lumen Adapted for; and   Proximal end of the distal catheter to establish fluid communication between their respective lumens Subcutaneous implantable means for connecting the end directly to the distal end of the proximal catheter.   63. The connection means includes a first mounting opening, a second mounting opening and a non-blocking passage therethrough. 63. The system of claim 62, having a body having a lesion lumen.   64. The first and second mounting openings are arranged at a relative angle in the range of 45 ° to 270 ° 64. The system of claim 63, wherein the system is configured.   65. 65. The system of claim 64, wherein the relative angle ranges from 90 degrees to 180 degrees. .   66. At least a distal portion of the lumen in the distal access cannula is 63. The system of claim 62, wherein the system is smaller than the lumen in the access cannula.   67. The lumen in the distal access cannula has a uniform diameter along its entire length. The proximal access cannula has a uniform diameter along its entire length And the diameter of the proximal access cannula is greater than the diameter of the distal access cannula lumen. 67. The system of claim 66, wherein the system is larger than the diameter.   68. Wherein said proximal access cannula lumen has a diameter of 1 mm to 6 mm and 68. The distal access cannula lumen has a diameter in the range of 3mm to 10mm. System.   69. The distal portions of the lumens of the distal access cannula are proximal 67. The system of claim 66, wherein the system has a diameter smaller than the diameter of the portion.   70. 70. The system of claim 69, wherein the distal portion has a length in the range of 5cm to 45cm. Stem.   71. A first mounting opening adapted to receive the first access cannula, A second mounting opening adapted to receive a second access cannula, and An implantable connector having a tubular body having a lumen there between, wherein the tubular body is , The first and second mounting openings are arranged at a relative angle in the range of 45 ° to 270 ° Is bent.   72. 72. The implantable according to claim 71, wherein the relative angle ranges from 90 ° to 180 °. Coupling.   73. Further, having a web disposed between the first and second mounting openings. 72. The implantable coupler of claim 71.   74. 72. The implantable implant of claim 71, wherein the lumen has a diameter in the range of 1 mm to 10 mm. Noh coupler.   75. The first opening having a diameter greater than the diameter of the second opening; 74. The implantable coupler of claim 74.   76. Kit with:   A system having a distal access cannula and a proximal access cannula;   Instructions describing the method of claim 1; and   A package containing the system and the instructions.   77. 77. The system of claim 76, wherein the system is sterile within the package. kit.