Catheter diffuser

ES 2 643 217 T3

DESCRIPTION

Peritoneal dialysis catheter

Field of the invention

The present invention generally relates to catheters with at least two lumens, one of which is a low lumen, and the other of which is a long lumen.

Background of the invention

Continuous-flow peritoneal dialysis is a technique that uses a certain amount of fluid, usually dialysate, that is constantly present in the abdomen. Continuous flow peritoneal dialysis previously known in the art has used two single lumen peritoneal dialysis catheters or a modified large internal diameter hemodialysis catheter. The inflow and catchment catheters allow inflow and outflow to remain constant. However, high dialysate flow rates and recirculation due to channeling or poor mixing within the peritoneal cavity are problems associated with continuous flow peritoneal dialysis.

In the continuous flow peritoneal dialysis technique, the peritoneal dialysis solution is used in a single pass or in a recirculation loop. Various recirculation systems are known, such as absorbent cartridges or dialyzers. Rapid drainage of fresh solution before contacting the peritoneal exchange surface has been a problem.

Regeneration systems include using a moderate volume batch of prepared fluid and recirculating the fluid until it is saturated. Another method provides an initial fixed volume of commercial dialysis solution for priming, followed by continuous regeneration of the used dialysate. Regeneration can be carried out by means of a hemodialysis filter or by absorption. Another method is the preparation of solutions from water in concentrate with in-line ultrafiltration.

The proximal ends of the two lumens are attached to a dialysate regeneration means, which is well known in the art. Regenerated dialysate, or fresh dialysate, is introduced into the abdomen through one of the catheters, which is connected to a means to provide regenerated or fresh dialysate, which is well known in the art.

For all the reasons mentioned above, it is important to have a continuous flow peritoneal dialysis catheter and method that effectively allows the dialysate to mix in the peritoneum while reducing trauma to the peritoneal walls. In addition, it is important to have catheters, and catheter diffusers, that gently dispense matter flowing through the catheter.

US 3,981,299 A describes a urethral catheter having three lumens communicating with openings at different lengths of the catheter. A catheter for continuous ambulatory peritoneal dialysis is disclosed in US 5,752,939 A and US 4 681 564. EP 0 445 502 A1 relates to an endotracheal tube incorporating a drug irrigation device. The drug irrigation device can have a useful and functional application also in medical-surgical tubes and catheters that have different functions.

Summary of the invention

The present invention relates to catheters according to independent claim 1. The present invention relates, in general, to continuous flow catheters with at least two lumens, one of which is a low lumen, and the other of which it's a long light. In this disclosure, the high beam, which is the pick-up light, is wound. It may have a plurality of openings, generally located within the coil, for the admission of matter flowing through the catheter.

The catheter includes a diffuser, which is located over the distal end of the low beam, to dispense material into the user's body. The high beam extends beyond, and through, the diffuser.

The catheter can also include a connector at the proximal ends of the at least two lumens. The connector may pass subcutaneously through the body of the catheter user, or the connector may be removable.

The catheter of the present invention is adapted to be used for peritoneal dialysis.

In a preferred aspect, the catheter includes at least one sleeve located proximal to the peritoneal membrane for adhesion of subcutaneous tissue. The catheter may contain lumens that are shaped like a D.

Furthermore, diffusers for a catheter are described as well as catheters having a diffuser. The diffuser has an inner part and an outer part and at least one opening for dispensing material into the body of the user.

ES 2 643 217 T3

In addition, the diffuser may have a plurality of openings through which matter can be dispensed into the wearer's body in a diffuse manner. The plurality of openings may be located radially around the sides of the diffuser in a manner generally perpendicular to the longitudinal axis of the catheter. Diffuser shapes generally consist of cylindrical, teardrop, bell, round, oval, semi-round, semi-oval, and a combination of shapes. The diffuser, and the catheter having a diffuser, can be used in a catheter used for continuous flow peritoneal dialysis.

In addition, methods for continuous flow peritoneal dialysis are described, including the steps of creating an incision in the user's body and separating the anatomical layers, making a circular suture in the peritoneal membrane, making an incision in the peritoneal membrane, inserting the catheter, and tensioning the parietal peritoneum. The method may also include anesthetizing the skin and peritoneal surface. In addition, the method may include making a lateral incision in the skin of the user, creating a skin tunnel, passing the catheter through the skin tunnel, connecting catheter fixings, and suturing the skin incision. The method can also include providing a catheter having a diffuser.

Brief description of the drawings

The accompanying drawings, which are incorporated in and form a part of the specification, illustrate embodiments of the present invention and, together with the description, serve to explain the principles of the invention. In the drawings, the same reference numerals are used to designate the same elements throughout the various figures.

Figure 1A is a perspective view of a cylindrical diffuser;

Figure 1B is a side elevation view of a round and / or oval diffuser;

Figure 1C-1 is a perspective view of a semi-oval diffuser having a D-shaped high beam;

Figure 1C-2 is a perspective view of a semi-round shaped diffuser having a round shaped high beam;

Figure 1D is a perspective view of a teardrop diffuser;

Figure 1E is a side elevation view of a bell-shaped diffuser;

Figure 2A is a top elevational view of a catheter with a diffuser and no connector;

Figure 2B is a top elevational view of a catheter with a diffuser and a connector;

Figure 2C is a top elevational view of a catheter with a diffuser and a removable connector;

Figure 2D is a top elevation view of a catheter with a diffuser and with an optional connector of any type;

Figure 3 is a top elevation view of a catheter without a diffuser and with an optional connector of any type;

Figure 4 is a cross section of a diffuser;

Figure 5A shows the catheter in use;

Figure 5B is a view of the diffuser in use;

Figure 5C is a view of a tunnelled proximal end;

Figure 5D is a view of a tunnelled proximal end;

Figure 6A is a cross section of a connector;

Figure 6B is a cross section of the double D lights in the connector;

Figure 6C is a cross section of the extensions in the connector;

Figure 7 is a flow chart of a method for continuous flow peritoneal dialysis;

Figure 8A is a side view of the extended high beam;

Figure 8B is a cross section showing two double D-shaped lights; Y

Figure 8C is a cross section showing two round shaped lights.

Detailed description of the invention

In describing embodiments of the invention illustrated in the drawings, specific terminology will be used for the sake of clarity. However, the invention is not intended to be limited to the specific terms selected in this way, and each specific term should be understood to include all technical equivalents that function in a similar manner to achieve a similar purpose. The words proximal, distal, short, and long are used herein for exemplary purposes, and should not be construed as limiting the present invention. The words proximal and distal refer to directions away from and closer to, respectively, the insertion tips of the first and second lumens in accordance with the present invention. The words short and long designate the length of lights relative to each other.

Reference is now made to Figures 2A, 2B, 2C, 2D, and 3 showing the catheter 10, 10 'of the present invention. As seen in these figures, the catheter contains at least two lumens, a first lumen 12 and a second lumen 14. The second lumen 14 is longer than the first lumen 12. For purposes of explanation, the second lumen 14 is also called a high beam 14 and the first light 12 is also called a low beam 12. Each lumen has a proximal end 16, 18 and a distal end region 20, 22. Each of the distal end regions 20, 22 of each of the at least two lumens 12, 14 has at least one opening, 24, 26 for the passage of matter 42 into the interior.

ES 2 643 217 T3 or outside the body of the user of the catheter 10, 10 '. Matter 42 passes through longitudinal light channel 112 defined by light wall 90.

The catheter 10, 10 'of the present disclosure may be adapted for use in various applications where body fluids, drugs, or other solutions are introduced into and removed from the body such as perfusion, infusion, plasmapheresis, hemodialysis, chemotherapy, and the like. . The area to be characterized can be the peritoneum, and it can be any suitable area within the body. Other areas in which catheter 10, 10 'can be used include, for example, any abscess cavity, postoperative cavity, and other areas of the body including inter-abdominal, subdiaphragmatic, and subhepatic areas. It should be understood by one skilled in the art from this disclosure that these areas are exemplary, and that catheter 10, 10 'can be used to withdraw or introduce matter into various areas to be catheterized. Furthermore, it will be understood by one skilled in the art based on this disclosure that the catheter 10, 10 'can be configured and adapted by increasing or decreasing the size of the catheter and / or the number of catheters and / or lumens, such that the catheter 10, 10 'can be used beneficially for other medical applications where matter is introduced into and / or removed from the body.

Matter 42 may pass into the body of the catheter user through low lumen 12, which may also be referred to as the delivery lumen. Matter can be removed from the body of the catheter 10 user through the long lumen 14, which may also be referred to as the pick-up or return lumen. However, it should be understood that, within the scope of the invention, the high beam 14 may also be a supply light and the low beam 12 may be a pick-up light.

The high beam 14 may be coiled and has at least one opening 26 for the passage of matter through the beam. The at least one opening 26 may be at the distal end 96 of the lumen 14. Furthermore, it is within the scope of this invention to position the at least one distal opening 26 along the side 98 of the distal end region 22 of the high beam 14.

The high beam 14 may have a plurality of openings 26 along the side 98 of the distal end region 22 of the light.

The plurality of apertures 26 may also be located along side 98 of the distal end region 22 of the lumen in a manner whereby all of the plurality of apertures 26 are located within the distal end region 22. winding the light. Figure 8A, extending the coil for exemplary purposes only, illustrates this embodiment. In addition, a distal opening 26 may optionally be included at end 96 of distal end region 22 of lumen 14.

As seen in Figure 8B, the lights 12, 14 may each have a D shape. However, it is within the scope of the invention to have lights 12, 14 that are round in shape, as seen in Figure 8C. Light shapes 12, 14, as shown in Figures 8B and 8C are intended to be exemplary only of the various light shapes that can be used with the present invention. It will be understood, based on this disclosure, that the present invention is not limited to the configurations shown in Figures 8B and 8C. One skilled in the art will appreciate that all forms of lights known in the art to be discovered are within the scope of the invention. In addition, the lights can each have shapes and sizes that vary from the other light or lights.

Optionally, as is known in the art, a radiopaque band 94 may be included in the wall 90 of the low beam 12 or high beam 14 to distinguish the lights from each other, particularly at their proximal ends 16, 18. Generally, the radiopaque band 94 will be positioned in the long span 14, since the longer length allows the user to more easily identify the radiopaque band 94.

Reference is now made to Figures 1A to 1E, 2A to 2D, 4, 5A and 5B, which illustrate a diffuser 30. It should be noted that the embodiment of catheter 10 'illustrated in Figure 3 does not contain a diffuser. Diffuser 30 may be added to catheter 10 and located over the at least one distal opening 24 in low lumen 12. High lumen 14 extends beyond diffuser 30 more distally into the body of the catheter user. As seen most clearly in Figures 1C-1, 1C-2, and 4, the high beam 14 can extend through the diffuser 30. In Figure 1C-1, the high beam 14 is D-shaped. In Figure 1C-2, the high beam 14 has a round shape.

The diffuser 30 has an inner portion 32 and an outer portion 34 and at least one opening 36 between the inner portion 32 and the outer portion 34. Matter 42 that is dispensed into the wearer's body flows through the low beam 12 and into the diffuser 30 at the opening 24 at the distal end of the light 12. The material 42 then flows through the at least one opening 36 in the diffuser and into the body of the user.

Diffuser 30 may have a plurality of openings 36 through which matter 42 enters the wearer's body in a diffuse manner. Furthermore, the plurality of openings 36 may be located radially around the sides of diffuser 30 in a manner generally perpendicular to the longitudinal axis of catheter 10.

The catheter 10 of the present invention is adapted to be used for continuous flow peritoneal dialysis. In peritoneal dialysis, matter 42 flowing through the catheter can be dialyzed. The diffuser 30 allows a

ES 2 643 217 T3 gentle interaction in the peritoneal structures from the effects of high dialysate flow rates, and allows the dialysate solution to easily mix in the peritoneal cavity 40. When used for continuous flow peritoneal dialysis, the openings radially located 36 allow dialysate 42 to exit perpendicularly generally 360 degrees from the diffuser.

Figures 1A to IE illustrate various shapes in which a diffuser 30 can be formed. Figure 1A illustrates a cylindrical shape, Figure 1B illustrates an oval and / or round shape, Figure 1C-1 illustrates a semi-oval shape, Figure 1C-2 illustrates a semi-round shape, Figure 1D illustrates a teardrop shape and Figure IE illustrates a bell shape. In addition, a diffuser 30 can be made of combinations of the shapes illustrated in Figures 1A 1E. The configurations of diffuser 30, as shown in Figures 1A through 1E, are intended to be exemplary only of the various configurations that can be achieved with the present invention. It will be understood, based on this disclosure, that the present invention is not limited to the configurations shown in Figures 1A to 1E.

When used for continuous flow peritoneal dialysis, the diffuser 30 provides a uniform discharge of the dialysate 42. The plurality of openings 36 diffuse the delivery pressure of the dialysate 42, which can provide a smooth interaction on the peritoneal membrane 38.

It should be understood that the dimensions of the invention can be modified for catheters of different size, embodiments, and different characteristics unique to the user of the catheter. Examples of dimensions that may be used include the following: the proximal end of diffuser 30 may be located less than 1mm from peritoneal membrane 38. In addition, the distance between the distal end of the diffuser 30 and the start of the coil in the distal end region 22 of the high beam 14 can be approximately 15 cm in length. Although the length of the spiral distal end region 22 of the high beam 14 can vary, its length can be approximately 8.875 inches. The light resistance can yield in the range of 100 to 300 ml / min. When the diffuser 30 is cylindrical in shape, the width 28 of the cylinder 1Al can be 0.5 cm long. Although any number of openings 36 can be used, the diffusers 30 can have openings in numbers ranging from six to twenty-four. It should be understood that these dimensions are exemplary only, and should not be construed as limitations of the invention.

As clearly illustrated in FIG. 4, the inner portion 32 of the diffuser 30 may have a proximal attachment region 82 and a distal attachment region 84, which are regions in which the high beam wall 90 14 it can be attached to diffuser 32. Attachment can be accomplished by means of glue, adhesive, heat bonding, or other means currently known in the art or to be discovered.

Reference is now made to FIG. 5A, which shows the general location of catheter 10 in peritoneum 100, when catheter 10 is used for continuous flow peritoneal dialysis. The diffuser 30 is located just distal to the peritoneal membrane 38. The coiled distal end region 22 of the long lumen 14 is located at the bottom of the Douglas cavity 92 of the peritoneum 100. In use, the catheter 10 separates the supply and the return of the dialysate 42. As a result, there is minimal recirculation of used dialysate 42. In use, fresh dialysate 42 enters peritoneum 100 through diffuser 30. Dialysate 42 passes through peritoneum 100 where the necessary physiological and chemical processes occur, and that turn fresh dialysate into used dialysate. Intraperitoneal volume can be maintained at high dialysate flow rates to maintain a high solute concentration gradient between plasma and continuously renewed dialysate solution 42. Used dialysate 42 is aspirated back out of the peritoneum 100 through the at least one opening 26 of the high beam 14.

The coiled design of the distal end region 22 of the long lumen 14 increases the mass of conduits separating the parietal and visceral layers of the peritoneum 100 so that they do not obstruct the at least one distal opening 26 for outflow of used dialysate 42 The use of a plurality of openings 26 can increase the outlet flow rate. The use of a coiled high beam 14 distal end region 22 is preferred for peritoneal dialysis as it is gentler on the viscera than the tip of a straight lumen.

Preferably, the catheter 10, 10 'is made of a low durometer silicone. However, polyurethane or other biocompatible materials known in the art or to be developed can also be used. Low durometer silicone is preferable due to its biocompatibility and softness, which is beneficial for use in the peritoneum 100, which is a relatively soft body structure. In addition, the low durometer silicone is flexible over a wide temperature range and has no clinically damaging leachable plasticizers.

The first lumen 12, the second lumen 14, and additional lumens in catheters having more than two lumens, and the diffuser 30 may be made of a biocompatible plastic or elastomer, more preferably a biocompatible elastomer. Suitable biocompatible plastics include materials such as, for example, polyethylene, vinyl acetate homopolymers and copolymers such as ethylene vinyl acetate copolymer, polyvinyl chlorides, acrylate homopolymers and copolymers such as polymethylmethacrylate, polyethylmethacrylate, polymethacrylate, polymethacrylate, ethylene glycol, ethylene dimethacrylate and hydroxymethyl methacrylate, polyurethanes, polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene, polycarbonates, polyamides, fluoropolymers such as homopolymers and copolymers of polytetrafluoroethylene and polyvinyl fluoride, polystyrenes, homopolymers and copolymers of styrene

ES 2 643 217 T3 acrylonitrile, cellulose acetate, homopolymers and copolymers of acrylonitrile butadiene styrene, polymethylpentene, polysulfones, polyesters, polyimides, polyisobutylene, polymethylstyrene and other similar compounds known to those skilled in the art. It should be understood that these possible biocompatible polymers are included above for exemplary purposes and should not be construed as limiting. If a biocompatible polymeric material is used to form the catheter 10, 10 ', it is most preferred that the polymeric material includes a polyurethane or a polyolefin polymeric material having a preferably soft durometer, as specified below.

Preferred biocompatible elastomers suitable for use in forming catheters 10, 10 'include biocompatible elastomers such as medical grade silicone rubbers, polyvinyl chloride elastomers, polyolefin homopolymeric and copolymeric elastomers, urethane-based elastomers, and natural rubber or other synthetic rubbers. The catheter 10, 10 'can be made of elastomeric material so that they are flexible, durable, soft, and easily adaptable to the shape of the area to be catheterized and / or the subcutaneous area and minimize the risk of damaging the walls of the vessel. If catheter 10, 10 'is used for hemodialysis applications, they can be formed of a soft silicone elastomer having a hardness of at least about 80-A on a Shore durometer scale. Such an elastomer is available from Dow Corning, and can include 20% barium sulfate in the elastomer to provide radiopacity. Although it is preferred to have a higher Shore durometer hardness if a biocompatible elastomer is used, particularly for hemodialysis, it is also possible to make a device from an elastomer having a lower Shore durometer hardness without departing from the spirit of the invention. It will be understood, based on this disclosure, that catheter 10, 10 'may also be radiopaque depending on its intended use.

Reference is now made to Figures 2B, 2C, 2D, 3, 5C, 5D and 6A to 6C, which show the invention with a connector 50, which is optional. When a connector 50 is provided, the proximal ends 16, 18 of the at least two lights 12, 14 are located on the connector 50. The lights 12, 14 can be attached to the connector 50 in a non-removable manner, as seen in the Figure 2B. Alternatively, the lights 12, 14 may be attached to a removable connector 50¹, as seen in Figure 2C. Detachable connectors are disclosed in a pending application, US Provisional Application Serial No. 60 / 329,593, entitled Detachable Hub. Furthermore, as illustrated in Figures 2D and 3, the use of all connectors 110 currently known in the art or to be discovered are within the scope of the invention. However, as illustrated in Figure 2A, the connector is optional, and the connectors included for exemplary purposes should not be construed as limiting. One skilled in the art will appreciate that the catheter 10, 10 'of the present invention can be used with a connector 50, a removable connector 50¹, without any connectors, or with connectors 110, or other attachments 110, currently known in the art or to be discovered.

In a preferred embodiment of the invention, as seen in Figures 2B, 5C, 5D and 6A-6C, a non-removable connector 50 may be used. As seen in these figures, the proximal ends 16, 18 of the at least two lights 12, 14 terminate at connector 50. In addition, the distal ends of extenders 56, 58 also terminate at connector 50. In this embodiment, when the lumens 12, 14 are D-shaped, the openings 102, 104 at the proximal end of the lumens 12, 14 are each D-shaped. Also, as seen in the embodiment illustrated in FIGS. Figures 6A to 6C, the distal openings 106, 108 of the extensions 56, 58 may each have a round shape. The extending distal end openings 106, 108 and the proximal end openings 102, 104 of the at least two lumens 12, 14 are brought into fluid communication with each other via connector channels 52, 54 molded into connector 50. The connector 50 is molded around a removable inner pin (not shown) that is round at one end and D-shaped at the other end. The shapes, sizes, and number of lights and extensions used with connector 50 are exemplary, and are not intended to be limiting. The proximal extension ends (not shown) are preferably connected to respective female Luer Locks (not shown) in a conventional manner. If chosen, the female Luer Lock fasteners can be substituted with any type of quick connect fitting, ferrule fixture, screw-in fixture, or any connecting means known in the art or to be discovered to achieve the flow of matter through. through catheter 10, 10 '. Extenders, as is known in the art, may be connected in fluid communication to respective fluid inlets and outlets of the dialysis unit, other fluid transfer equipment, or other apparatus necessary to carry out the purpose for the catheter. 10, 10 '.

As mentioned above, the connector 50, 50 'and the extensions 56, 58 of the catheter 10, 10' are optional. The catheter 10, 10 'of the present invention may simply be formed as at least two lumens 12, 14. The proximal ends 16, 18 of the lumens could be made connectable to dialysis equipment or other devices by providing Luer closures or other parts. attachment to the proximal ends 16, 18 of the lights without a connector or additional extensions.

When the catheter 10, 10 'has a connector 50 that is not removable, generally, the connector 50 will be able to pass through the subcutaneous layer 48 of the body of the catheter user. As seen in Figures 5C and 5D, proximal ends 16, 18, connector 50, and extensions 56, 58, can be passed through a subcutaneous tunnel into the subcutaneous layer 48 of the body using various tunneling techniques. . Proximal ends 16, 18, connector 50, and extensions 56, 58 can be inserted into tunnel entry incision 86 and tunnelled through subcutaneous layer 48 to tunnel exit incision 86. Alternatively, proximal ends 16, 18 of the lumen, connector 50, and extensions 56, 58 can be inserted into incision 110 of

ES 2 643 217 T3 entering the catheter and tunneling through the subcutaneous layer 48 to an incision 86 exiting the tunnel. In similar ways, catheters 10, 10 'that do not have connectors or that have removable connectors 50', the proximal ends 16, 18 of the lumen can be tunnelled subcutaneously.

Reference is now made to Figures 2A through 2D, 3, 4 and 5A-5D, which illustrate the inclusion of at least one sleeve 44, which is optional. In addition, a second sleeve 46 may also be included, which is optional. The at least one sleeve 44, as is known in the art, is made of a material, generally polyester, on which the tissue of the catheter user can grow in order to secure the catheter 10, 10 'to the user's body. . A sleeve 44 is located just proximal to the peritoneal membrane 38, when the catheter 10, 10 'is used for continuous flow peritoneal dialysis. The cuff 44 may be located between 0 and 5 mm proximally from the peritoneal membrane 38. If the peritoneal membrane 38 is sutured at the incision site of the catheter 10, 10 ', added space may be necessary since the suture, when pulled from it, you can create folds in the membrane 38. Preferably, the space between diffuser 30 and sleeve 44 will be in the range of 0.5-10mm. The distance interval between the first sleeve 44 and the second sleeve 46 will preferably be 10 cm. It should be understood that the dimensions of the sleeves 44, 46 may be modified for catheters of different size, embodiments, and different characteristics unique to the user of the catheter. The dimensions listed are not intended to be limiting, instead they are included for exemplary purposes.

As seen in FIG. 5C, a second sleeve 46 may be located under the skin distal to the exit port 86 for catheter 10, 10 '.

Reference is now made to FIG. 7, which is a flow chart for the method for continuous flow peritoneal dialysis. The method includes creating an incision in the user's body and separating anatomical layers until the peritoneum is found; performing a circular suture in the peritoneal membrane 64; insert the distal end of the catheter into the Douglas cavity of the peritoneum, guided by a semi-rigid wire into the outflow lumen, and tension the parietal peritoneum between the diffuser and the cuff by tensioning the circular suture in the peritoneal membrane 68 . In addition, the method may include, anesthetizing under the skin to the peritoneal surface with a syringe 60. Additionally, the method may include making a lateral incision in the skin of the user 70; create a subcutaneous tunnel, also known as a skin tunnel 72; passing the proximal end of the catheter subcutaneously through skin tunnel 74, which can be accomplished by means of a tunneller; fix connection brackets to lights 76; and suturing the skin incision 78.

The method may also include providing a catheter 10 having a diffuser 30.

The stage 62 incision can be approximately 3 cm long, and the stage 70 incision can be approximately 10 cm long. It should be understood that the dimensions of the incisions can be modified for catheters of different size, embodiments, and different characteristics unique to the user of the catheter. The dimensions listed are not intended to be limiting, instead they are included for exemplary purposes.

A sheath (not shown), as is commonly known in the art, can be inserted over the diffuser prior to insertion of catheter 10 into the body. Since diffuser 30 is preferably made from a low durometer silicone, it can be easily compressed into the optional sleeve. The sheath decreases the volume of diffuser 30, which can allow insertion of catheter 10, including diffuser 30, using a smaller incision than would be possible without the use of a sheath. A Quill sheath is commonly known in the art, and can be used for a catheter 10 that does not have a connector. If catheter 10 has a connector 50, which is not removable, a removable sheath can be used, which is commonly known in the art.

When a catheter 10, 10 'having a connector 50 that is not removable, is passed through the skin tunnel subcutaneously 76, the subcutaneous layer 48 will have to be stretched to allow the connector 50 to pass. Normally, the elasticity of the subcutaneous layer 48 will allow subcutaneous tissue to encapsulate lumens 12, 14 after passage of connector 50. When using a removable connector 50¹ on catheter 10, 10 ', connector 50¹ it is among the fixtures connected to the catheter during step 76 of connecting fixtures to the catheter.

As is known in the art, the open ends of the Luer Lock closures may be connected in fluid communication to respective fluid inlets and outlets of the dialysis unit, or other fluid transfer equipment in order to begin dialysis.

Although the invention has been described and illustrated by various embodiments, it will be apparent to those skilled in the art that changes and modifications could be made that are clearly within the scope of the invention. It is therefore understood that the invention is intended to be protected broadly within the scope as defined by the appended claims.