In general, the present invention is related to methods and devices for introducing and/or draining fluids into and/or from a patient body.
In general, there are two methods whereby a patient's body can be accessed to drain, or withdraw, fluids therefrom, and to deliver fluids thereto. These two methods typically employ patient access devices in the form of catheters or needles respectively.
The catheters are typically transcutaneously implanted on the patient's body and then left in place for extended periods for repeated use, such as to perform more than one treatment. Transcutaneous catheters have distal ends which are typically positioned to be in fluid flow communication with a body cavity, or vessel, or the like. A proximal end of the catheter is then positioned outside the patient body. Fluids are drained, or withdrawn, from the patient body, or delivered to the patient body, by connecting a tubing set to the proximal end of the catheter.
Needles are typically used once only so as to perform a single treatment, and are then discarded. They are typically transcutaneously inserted into a patient body to perform a fluid transfer operation and then withdrawn from the patient body and disposed of after the fluid transfer operation has been completed.
Patients afflicted with end stage renal disease where kidney transplantation is not a viable option, may be treated by hemodialysis or peritoneal dialysis to remove toxic products from the patient's blood. Both techniques operate by the principles of diffusion across semipermeable membranes.
In the case of peritoneal dialysis, the membrane that is used is the patient's peritoneal membrane. In order to perform peritoneal dialysis, a dialysis solution, or dialysate, is delivered into the peritoneal cavity of the patient and caused to remain in the cavity for a dwell period of typically four to six hours, for example. The dialysis solution typically comprises an electrolyte component, to reduce loss of electrolytes, and a sugar component, which acts as an osmotic ingredient to remove water from the patient along with normal metabolic products, such as urea, uric acid, creatinin and/or the like. At the end of the dwell period, spent dialysis solution is drained from the cavity and the cavity is refilled with fresh dialysis solution. Such a dialysate draining and refilling operation is normally performed periodically so as to replace spent dialysate with fresh dialysate.
Conventional peritoneal dialysis systems, currently in use, usually employ patient access devices, in the form of catheters, which are used to access the peritoneal cavity during dialysate draining and refilling operations. Such catheters are normally implanted transcutaneously through the patient's abdomen by a surgeon. When implanted, a distal end of the catheter is positioned to be in flow communication with the peritoneal cavity, and a proximal end of the catheter is positioned outside the patient body. Thereafter, the periodic operation of draining spent dialysate from the peritoneal cavity and refilling the peritoneal cavity with fresh dialysate, is normally performed by the patient.
In conventional dialysis solution delivery systems use is made of a tubing set, often referred to as fluid flow set, to perform a draining and refilling operation. The tubing set is typically connected, or connectable, to a container, containing fresh dialysate, and to an empty container. Such tubing sets can be supplied independently of the containers, or with associated containers pre-mounted thereon so as to form dialysis solution container and tubing set assemblies. To perform the draining and refilling operation, the tubing set is releasably connected to the proximal end of the transcutaneous catheter positioned outside of the patient's body. To this end, complementary connectors are provided on the tubing set and proximal end of the transcutaneous catheter. Accordingly, an external connector connected to the tubing set is coupled to a complementary external connector connected to the transcutaneous catheter. When the connector on the transcutaneous catheter is connected with the complementary connector on the tubing set in this fashion, the spent dialysate is drained from the peritoneal cavity through the transcutaneous catheter and tubing set and into the empty container. When the spent dialysate has been drained from the peritoneal cavity, the peritoneal cavity is replenished with fresh dialysate delivered through the tubing set and transcutaneous catheter to the peritoneal cavity from the other container. Thereafter, the tubing set is disconnected from the transcutaneous catheter, and the transcutaneous catheter is left in place on the patient to permit subsequent draining and refilling operations to be performed in similar fashion.
The peritoneal cavity is particularly susceptible to infection. It has been found that the exterior end of the transcutaneous catheter, protruding from the patient's body, can be a source of contamination of the peritoneal cavity. Consequently, the use of such conventional peritoneal dialysis systems has been rather limited.
A new alternative dialysis solution delivery system, arranged to decrease such risks of contamination, has been developed. The alternative dialysis solution delivery system employs a patient access device in the form of an access tube for accessing a subcutaneously implanted port, instead of a transcutaneous catheter, through which a dialysis solution can be delivered to and/or drained from the peritoneal cavity. The port is arranged transcutaneously to receive any appropriate access tube, such as, for example, a sharp ended needle, a blunt ended needle, a Huber needle, or the like. To access the port, such an access tube is transcutaneously inserted through the patient's skin. Dialysis solution is then selectively delivered to and/or drained from the peritoneal cavity by making use of dialysate containers and an associated tubing set connected to the access tube in a manner similar to that described above.
After a dialysate draining and refilling operation, the access tube is withdrawn from the patient. Accordingly, between dialysate draining and refilling operations, there is an absence of an access device which protrudes from the patient. Consequently the risks of infection of the peritoneal cavity is at least reduced.
A variety of conventional dialysis solution delivery systems are currently available. Such systems typically have manufacturer specific external connectors on the catheters and associated tubing sets respectively. The external connectors of different types of dialysis solution delivery systems are often structurally different. Thus, for example, the external connectors employed by one manufacturer of dialysis solution delivery systems of the transcutaneous catheter type often differ structurally from the external connectors employed by other manufacturers of dialysis solution delivery systems of the transcutaneous catheter type. Therefore, transcutaneous catheters and associated tubing sets made by different manufacturers can normally not be used interchangeably. Consequently, after a specific catheter has been transcutaneously implanted in a patient, the patient is obliged to obtain specific associated tubing sets having external connectors which correspond to the connector of the transcutaneous catheter which has been implanted, so as to enable the periodic draining and refilling operations to be performed by the patient.
It would be advantageous if such conventional tubing sets, or dialysis solution container and tubing set assemblies, having such specific conventional external connectors, could be rendered selectively operable with a subcutaneous port, in addition to the specific transcutaneous catheters for which they are designed. The conventional tubing sets could then be used to access an implanted port as well as their associated catheters. In such a case, a patient would not be limited to obtaining only tubing sets, and/or dialysis solution container and tubing set assemblies, specifically designed to access the subcutaneous port, but would have the option of using currently available tubing sets, and/or dialysis solution container and tubing set assemblies, also. Furthermore, the availability of tubing sets operable with subcutaneous ports would be increased. Should tubing sets associated with access tubes be unavailable, currently available tubing sets, or dialysis solution container and tubing set assemblies, could then be used instead. Stockists, or stockers, of such items, would then not need to increase their inventory to make specific provision for tubing sets associated specifically with access tubes, since the currently available tubing sets would be rendered usable to access a subcutaneous port.
Furthermore, it would be advantageous if tubing sets and associated catheters of the conventional type, could be rendered usable interchangeably. Stockists, or stockers, of such items, would then not need to carry a wide range of different tubing sets, since the currently available tubing sets would be rendered usable interchangeably with a specific implanted transcutaneous catheter.
In the case of hemodialysis, a dialysis operation on a patient's blood is performed outside the patient's body. An artificial semipermeable membrane, as opposed to the peritoneal membrane in the case of peritoneal dialysis, is typically used to perform the dialysis operation. Blood is typically withdrawn from the patient by means of a dialysis machine, and dialysis of soluble substances and water from the blood is performed by diffusion through the artificial semipermeable membrane. After such dialysis, the blood is typically returned to the patient's body.
Traditionally, hemodialysis has been performed by releasably connecting conventional tubing sets of a hemodialysis machine with complementary access devices, such as transcutaneous catheters extending from the patient's body, so as to perform a hemodialysis operation. Conventional connectors, in the form of a 6% taper male and female Luer type connectors, are used to connect the tubing sets with the access devices. The connectors used have specific internal diameters. It has been found that if connectors having internal diameters greater than the internal diameters of the conventional connectors were to be used, higher blood flow rates could be achieved during a hemodialysis operation. The time taken to perform an average hemodialysis operation could then be reduced and patient discomfort would be decreased. However, should non-conventional tubing sets and non-conventional catheters, having connectors with such greater internal diameters, be introduced for use in hemodialysis, compatibility between the conventional tubing sets and catheters currently in use, and such non-conventional tubing sets and catheters, can arise. For example, it could happen that a user ends up with a conventional tubing set with its associated connector, and a non-conventional transcutaneous catheter with its associated connector, and, consequently, would then be unable to connect the one with the other to perform a hemodialysis operation. It could also happen that a user ends up with a conventional transcutaneous catheter with its associated connector and a non-conventional tubing set with its associated connector, and, consequently, would then also be unable to connect the one with the other to perform a hemodialysis operation.
Accordingly, it would be advantageous if tubing sets and associated access devices having connectors with relatively large internal diameters could be introduced for use in hemodialysis, thereby to enable higher blood flow rates to be achieved during a hemodialysis operation. Furthermore, it would be advantageous if such non-conventional tubing sets and associated access devices, having connectors with relatively large internal diameters, could be introduced such that they are not only connectable with each other, but with the conventional tubing sets and access devices currently in use in hemodialysis also. In such a case, compatibility problems between such non-conventional hemodialysis access devices and tubing sets, having the relatively large internal diameter connectors, and the conventional hemodialysis tubing sets and access devices currently in use, would be avoided.
It will be appreciated that a hemofiltration procedure is normally performed in a fashion similar to hemodialysis. The tubing sets and access devices used in hemofiltration are typically similar to those used in hemodialysis. Accordingly, it is to be appreciated that, where appropriate, whenever the term hemodialysis is used in this specification, it should be interpreted to extend to hemofiltration as well. Furthermore, although the invention will be described with reference to its application in the fields of peritoneal dialysis, hemodialysis and hemofiltration, it is to be appreciated that the application of the invention is not to be limited to these fields only, but extends to the field of delivering and/or draining fluids into and/or from a patient body in general.
Accordingly, it is an object of this invention to provide access tube sets, or needle sets, arranged to be connectable to specific connectors of conventional tubing sets, which specific connectors are arranged normally to be coupled with specific complementary connectors on transcutaneous catheters, thereby to render such conventional tubing sets coupleable with subcutaneous ports.
It is another object of this invention to provide access tube sets, or needle sets, which are arranged to be connectable to specific connectors on conventional tubing sets currently used in peritoneal dialysis, so as to render such conventional tubing sets coupleable with subcutaneous ports.
It is yet another objective of this invention to render different types of conventional tubing sets and associated catheters currently used in peritoneal dialysis compatible with one another, so as to enable such different tubing sets and associated catheters to be usable interchangeably.
It is yet another object of this invention to provide non-conventional tubing sets and associated access devices for use in hemodialysis, which tubing sets and associated access devices have complementary connectors with internal diameters larger than the internal diameters of the connectors currently used on conventional hemodialysis tubing sets and associated access devices.
It is yet a further object of this invention to provide non-conventional tubing sets and associated access devices for use in hemodialysis, which tubing sets and associated access devices have complementary connectors with internal diameters larger than the internal diameters of the connectors currently used on conventional hemodialysis tubing sets and associated access devices, and which non-conventional tubing sets and access devices are not only connectable with each other, but with conventional tubing sets and access devices currently used in hemodialysis also.
According to one aspect of the invention, there is provided a method of fluidically communicating between a patient's body and an extracorporeal tubing set. the method comprises providing an extracorporeal tubing set having a fluid transfer tube defining opposed ends, an access tube for selectively connecting one end of the fluid transfer tube percutaneously to a subcutaneously implanted port, and an external connector for selectively connecting the one end of the fluid transfer tube extracorporeally to a transcutaneous catheter.
According to another aspect of the invention, there is provided a method of fluidically communicating between a patient's body and at least two different extracorporeal tubing sets. The method comprises providing an access device for accessing the patient's body, the access device having a distal end portion transcutaneously positionable in the patient's body and an opposed proximal end, a first connector for connecting the proximal end selectively to a connector on a first tubing set, and a second connector for connecting the proximal end selectively to a different connector on another tubing set.
According to another aspect of the invention, there is provided a method of fluidically communicating between a patient's body and at least two different patient access devices. the method comprises providing a tubing set comprising a fluid flow tube having a distal end and an opposed proximal end, the tubing set further comprising a first connector, for connecting the distal end of the fluid flow tube selectively to a connector on one access device, and a second connector, for connecting the distal end of the fluid flow tube selectively to a different connector on another access device.
According to yet another aspect of the invention, there is provided an extracorporeal tubing set. The extracorporeal tubing set comprises at least one fluid transfer tube for transferring a fluid to or from a patient body, said tube having at least a proximal end and a distal end, wherein the proximal end is operatively connected, or connectable, to an extracorporeal instrument, medicament, or receptacle. the tubing set further comprises an access tube operatively connected, or connectable, to the distal end of the fluid transfer tube, said access tube being percutaneously connectable to an implanted port, and an external connector operatively connected, or connectable, to the distal end of the fluid transfer tube, said external connector being externally connectable to a transcutaneous catheter.
According to another aspect of the invention, there is provided a dialysis tubing set comprising a fluid transfer tube having a proximal end and a distal end, wherein the proximal end is connectable to a source of dialysis solution, an access tube connected, or connectable, to the distal end of the fluid transfer tube, said access tube percutaneously connectable to an implanted port, and an external connector connected, or connectable, to the distal end of the fluid transfer tube, said external connector externally connectable to a transcutaneous catheter.
According to a further aspect of the invention, there is provided an access tube set for adapting at least one tubing set, having an external connector normally connectable to a specific complementary connector of a transcutaneous catheter, so as to render the tubing set operatively connectable with an implanted subcutaneous port. The access tube set comprises an access tube connectable with the implanted subcutaneous port, and a connector operatively connected to the access tube, the connector being complementary to the external connector of the tubing set, so that the connector of the access tube set can be connected to the external connector of the tubing set thereby to render the tubing set selectively connectable to the implanted port.
According to another aspect of the invention, there is provided an adapter kit for adapting any one of a plurality of different tubing sets, each having a specific external connector normally connectable to a specific complementary external connector of a transcutaneous catheter, so as to render any one of the plurality of different tubing sets selectively connectable with an implanted subcutaneous port. The adapter kit comprises an access tube set having an access tube connectable with the implanted subcutaneous port and a connector operatively connected to the access tube, the connector being complementary to the external connector of a specific one of the different tubing sets so that the access tube set can be connected to that external connector to render that tubing set operatively connectable to the implanted port. The adapter kit further comprises at least one adapter comprising a first connector, releasably connectable to the connector of the access tube set, and an opposed connector connected to the first connector, the opposed connector being complementary to the external connector of another specific one of the different tubing sets, the adapter being mountable on the connector of the access tube set thereby to enable the access tube set to be connected to the external connector of the other specific one of the different tubing sets thereby to render the other specific one of the different tubing sets operatively connectable to the implanted port.
According to a further aspect of the invention, there is provided an access tube set comprising an access tube arranged to access a patient body, and at least two different connectors operatively connected, or connectable, to the access tube, each connector being complementary to a different conventional connector of a different conventional tubing set, so as to render the access tube selectively connectable to any one of the different conventional tubing sets.
According to another aspect of the invention, there is provided an access tube set comprising an access tube arranged to access a patient body, and at least two different connectors operatively connected, or connectable, to the access tube, each connector being complementary to a different conventional connector of a different conventional tubing set, so as to render the access tube selectively connectable to any one of the different conventional tubing sets.
According to another aspect of the invention, there is provided an access device, for accessing a patient body to perform a fluid transfer procedure, the access device comprising an accessing portion arranged to access a patient body, and at least two connectors operatively connected, or connectable, with the accessing portion, each connector being complementary to a different connector of different tubing sets so as to render the access device selectively coupleable to any one of the different tubing sets.
The invention will now be described, by way of example, with reference to the accompanying diagrammatic drawings, in which:
The present invention will now be described in an application to delivering and draining a dialysis solution to and from a peritoneal cavity in a patient body. Thereafter, the invention will be described in an application to hemodialysis and hemofiltration.
As mentioned, peritoneal dialysis typically requires periodic draining of spent dialysis solution from the peritoneal cavity and replacement of the spent dialysis solution with fresh dialysis solution. The dialysis solution, or dialysate, typically comprises a solution which will promote diffusion or osmosis across a patient's peritoneal membrane, so as to remove toxic by-products from the patient's blood. In particular forms of peritoneal dialysis, such as Continuous Ambulatory Peritoneal Dialysis (CAPD) and Continuous Cycling Peritoneal Dialysis (CCPD), the dialysate, after initial delivery into the peritoneal cavity, remains in the cavity for a dwell period of usually 4 to 6 hours. During this time, the dialysate removes normal metabolic products such as urea, uric acid, creatinin, and/or the like, from the patient's body, by osmosis through the peritoneal membrane. At the conclusion of the dwell period, the used or spent dialysate is drained from the peritoneal cavity and typically replaced by a new supply of unused or fresh dialysate.
Referring to
The dialysis solution container and tubing set assembly 14 includes containers 20, 24 and a tubing set, sometimes referred to as a fluid flow set, generally indicated by reference numeral 12. The tubing set 12 includes an access tube, schematically indicated in simplified form at 18, typically in the form of a needle, for selectively accessing the implanted subcutaneous port 16. Container 20 is for delivery of dialysis solution to the peritoneal cavity, and, accordingly, is normally filled with fresh dialysate. Container 20 is connected in fluid flow communication with a first fluid transfer tube 22 of tubing set 12. The container 20 can be releasably coupled to the tube 22 by means of a coupling 22A. Container 24 is for receiving spent dialysis solution, and, accordingly, is normally empty. Container 24 is connected in fluid flow communication with a second fluid transfer tube 26 of tubing set 12. The container 24 can be releasably coupled to the tube 26 by means of a coupling 26A. Containers 20 and 24 are typically of a flexible material such as a polymer, or synthetic plastics material, or the like. The first tube 22 and the second tube 26 are typically connected to a junction at 28. A fluid flow controller 30 on tube 22 and a similar controller 32 on tube 26 can be provided to regulate dialysate flow from and to the containers 20 and 24. The fluid flow controllers 30, 32 can comprise clamps, or the like, for example. The fluid flow controllers 30, 32 can be used alternately to block fluid flow to or from the containers 20, 24, or to increase or decrease dialysate flow through the tubes 22, 26.
The access tube 18 extends from a single fluid transfer tube 34 which is coupled in fluid flow communication to junction 28. A further fluid flow controller can be provided at 35. Access tube 18 typically has a relatively large bore to permit relatively high flow rates of dialysate therethrough. Access tube 18 can be in the form of any appropriate access tube, such as, for example, a large bore coring needle, a blunt ended needle, a fistula needle, a Huber needle, or the like. By “coring needle” is meant a non-Huber type access tube. Such a coring needle can have a distal tip 23 defining a sharp or blunt end capable of penetrating tissue in a forward direction so as to engage with port 16. Instead, access tube 18 can be in the form of a needle having a non-coring design, such as a Huber needle, which has a side-facing distal opening. Access tube 18 typically has an outer diameter of at least 1.6 mm (16 G). Instead, it can have an outer diameter of at least 1.83 mm (15 G), or at least 2.13 mm (14 G), or at least 13 G. It can have a bore size as large as 12 G, or larger. The access tube 18 can be made of any suitable material, such as, stainless steel or surgical steel, a hard plastics material, or the like.
Optionally, a connector 36, such as a Luer type connector, can be provided, so as to render access tube 18 detachably connected to the tube 34 to permit access tube replacement, thereby to inhibit contamination by using the same access tube more than once if the tubing set 12 is used more than once.
Referring to
Referring to
Referring again to
In use, fresh dialysate is initially introduced into the peritoneal cavity C by transcutaneously accessing the port 16 with the access tube 18, and then permitting fresh dialysis solution to flow or drain from the container 20, through access tube 18, along the fluid flow passage defined by catheter 38, and into the peritoneal cavity C. This can be achieved by holding container 20 at an elevation above the peritoneal cavity C to permit the dialysate to gravitate from the container 20 into the peritoneal cavity C. After the dialysate is delivered in this way, access tube 18 is withdrawn from port 16.
After a certain period, e.g., four to six hours, typically another system 10 is used to drain the now spent dialysis solution from the peritoneal cavity C and to deliver fresh dialysate into the cavity C. Access tube 18, is inserted through the skin S of the patient and into the port 16. Typically, the spent dialysate is permitted to drain or gravitate from the peritoneal cavity into the container 24. Fluid flow controller 30 is typically in a closed condition when the spent dialysate is drained into container 24 to prevent fluid contact between fresh dialysate in container 20 and the spent dialysate draining from the peritoneal cavity C into container 24. The draining of the spent dialysate from the peritoneal cavity C is typically achieved by holding container 24 at an elevation below the peritoneal cavity C to permit the dialysate to gravitate from the peritoneal cavity C and into container 24.
After the spent dialysate has been drained, fresh dialysate is caused to flow or gravitate from container 20 through the catheter 38 and into the peritoneal cavity C in a fashion similar to that described above. This is typically achieved by closing fluid flow controller 32 and opening fluid flow controller 30 to inhibit contamination of the fresh dialysate by the spent dialysate. Once the delivery of fresh dialysate into the peritoneal cavity C of the patient has been completed, access tube 18 is removed from the patient. After a period of typically four to six hours, the above operation is repeated.
Although the system 10 can be reused by refilling container 20 with fresh dialysate and disposing of the spent dialysate in container 24, for hygienic purposes, such a procedure is not normally followed. The tubing set 12 can be retained for subsequent use and containers 20 and 24 replaced with fresh containers by removing the used containers from the couplings 22A, 26A and replacing them with fresh containers. An unused, or fresh, access tube 18 can then be connected to the tubing set 12 by detaching the used access tube 18 from the connector 36 and replacing it with such an unused access tube. Such a procedure is also not normally followed. Instead, each time a draining and refilling operation of the peritoneal cavity C is performed, use is made of a fresh dialysis solution container and tubing set assembly 14, in which container 20 is pre-filled with fresh dialysate and container 24 is empty to receive spent dialysate from the peritoneal cavity C. The containers 20, 24 and the tubing set 12, can typically be supplied separately, in which case the containers 20, 24 are connected to the tubing set 12 by the patient prior to a dialysate draining and refilling operation. Instead, complete dialysis solution container and tubing set assemblies 14 can be provided, in which case containers 20, 24 are supplied together with tubing set 12. In view of the importance of hygiene and the susceptibility of the peritoneal cavity to infection, such fresh dialysis solution container and tubing set assemblies 14, or containers 20 and 24 and tubing sets 12, are typically supplied in packages and in a sterile condition.
Referring now to
The systems 110, 120, and 130 are schematic representations of available dialysis solution systems. Each system functions in similar fashion. However, the external connectors at 116, 126, and 136 differ. In
Referring to
In accordance with one aspect of the invention, an access tube set, or needle set, is provided, which renders the currently available conventional peritoneal tubing sets, such as those represented and schematically indicated by reference numerals 112, 122, and 132 in
Referring now to
The needle sets 140, 150, 160, can each be provided separately, typically in packages and in a sterile condition. A patient having an implanted port 16, can then obtain an appropriate needle set 140, 150, 160, so as to render a corresponding conventional tubing set 112, 122, 132 compatible with the implanted port 16.
In accordance with another aspect of the invention, tubing sets 112, 122, 132, or the container and tubing set assemblies 110, 120, 130, can be provided with an associated needle set 140, 150, and 160, respectively, to render such tubing sets, or assemblies, selectively connectable to the conventional complementary connectors of transcutaneous catheters 114, 124, 134, and, in addition, to the port 16 as shown in
An example of a conventional dialysis tubing set, having an associated needle set pre-mounted thereon, in accordance with the invention, to render it selectively coupleable to an implanted port or a conventional corresponding transcutaneous catheter, is generally indicated by reference numeral 210 in
In
Referring now to
Referring now to
Referring now to
External connectors 212, 312, 312A, 412, can be complementary to any one of the conventional types of connectors currently in use to perform peritoneal dialysis operations.
According to another aspect of the invention, the needle, or access tube sets, 140, 150, and 160 of
Referring now to
Kit 170 further includes a plurality of adapters 174, 176, of which only two are shown schematically by way of example. It will be appreciated that any number of such adapters can be supplied with the kit to widen the range of currently available tubing sets to be rendered compatible with port 16. Each adapter 174, 176 has a connector 174A, 176A which is complementary to a specific type of currently available tubing set connector. The adapters have opposed connectors 174B, 176B. One of the opposed connectors, in this case connector 174B, is complementary to connector 142 so as to be releasably coupleable therewith. The opposed connector 176B of the other adapter is complementary to connector 174A of adapter 174. Accordingly, the adapters 174, 176 can be connected one to another in series on the connector 142.
Although adapters 174, 176 are shown as having tube portions 174C, 176C, it will be appreciated that, instead, the connectors 174A, 176A can be connected directly to the opposed connectors 174B, 176B as indicated by reference numerals 174D and 176D in
In use, needle set 172 and the adapters 174, 176, or 174D, 176D, can be connected one to another in series so as to define an adapter chain, as indicated at 176E in
In one embodiment, for example, the connector 142 can be complementary to a Baxter type connector. A single adapter, similar to the adapter 174D can be provided. Such an adapter can have opposed ends in which a connector 174B, complementary to the Baxter type connector, is defined at its one end, for releasable connection to a Baxter type connector 142. Another type of connector 174A, such as a Fresnius type of connector, can then be defined at the opposed end of the adapter 174D. Conveniently, a cap can be provided for releasable connection to the Fresnius type connector when the adapter is not in use. Such a kit can then be used selectively to adapt a tubing set carrying a Baxter type external connector or a tubing set carrying a Fresnius type external connector for use with a subcutaneous port.
Instead, adapters 174, 176, or 174D, 176D, can each have an opposed connector coupleable with connector 142, shown in
Referring to
In this manner, tubing sets 112, 122, 132, or the container and tubing set assemblies 110, 120, 130, can be provided with associated adapters, to render such tubing sets, or assemblies, selectively connectable to the conventional complementary connectors of transcutaneous catheters 114, 124, 134, and, in addition, to the port 16 as shown in
The application of the invention in the field of hemodialysis will now be described. Hemofiltration is performed utilizing tubing sets and access devices similar to those used in hemodialysis. Accordingly, even though the invention will now be described with reference to hemodialysis, it will be appreciated that the invention applies to hemofiltration as well.
Traditionally, hemodialysis has been performed using specific, conventional, connectors, to connect an extracorporeal hemodialysis tubing set to a patient access device, such as a transcutaneous catheter, so as to perform a hemodialysis operation. The conventional connectors which have been used to date are in the form of male and female Luer type connectors having internal diameters of a specific size. The male Luer type connectors are normally mounted on the hemodialysis tubing set and the female Luer type connectors are normally mounted on the access device, used to access the patient. As mentioned, it has been found that should non-conventional connectors, having larger internal diameters than the conventional Luer type connectors which are currently being used, be used instead, hemodialysis procedures would be enhanced by enabling higher blood flow rates to be achieved. Since the conventional tubing sets and access devices are often supplied separately, it would be advantageous to provide such non-conventional hemodialysis tubing sets and access devices having such larger internal diameter connectors such that the non-conventional hemodialysis tubing sets and access devices can be used with the conventional hemodialysis access devices and tubing sets as well. In such a case, compatibility problems between the conventional and non-conventional hemodialysis tubing sets and access devices would be avoided.
An access tube set, or needle set, which can be used advantageously in hemodialysis, and/or hemofiltration, in accordance with another aspect of the invention, will now be described with reference to
Referring to
The access tube 18 is mounted at an end of a tube 512. A non-conventional connector 514 is connected to, typically bonded with, an opposed end of the tube 512. The connector 514 can be in any appropriate form, but has an internal diameter greater than the internal diameter of the conventional Luer type connectors currently used in hemodialysis and hemofiltration procedures. Conveniently, the connector 514 is in the form of a Luer, or Luer-like, female connector 514. The connector 514 is arranged to be releasably connectable to a complementary non-conventional connector on a non-conventional tubing set of a hemodialysis, or hemofiltration, machine. Naturally, if the connector 514 is in the form of a Luer, or Luer-like female connector, the corresponding connector on the non-conventional tubing set would be in the form of a complementary Luer, or Luer-like, male connector. Such a complementary Luer, or Luer-like, male connector, of such a non-conventional hemodialysis, or hemofiltration, tubing set, is indicated by reference numeral 522 in
Referring again to
With reference to
The tube 520 is connected to the non-conventional connector 522. Where a non-conventional tubing set 518 is used, the needle set 510 can be used to render the tubing set 518 compatible with a subcutaneous port 16, similar to the one shown in
Referring now to
Although in conventional hemodialysis and hemofiltration procedures, the conventional male Luer type connector is normally on the tubing set and the corresponding conventional female Luer type connector is on the access device, such as the transcutaneous catheter, this need not be the case. Instead, the conventional male Luer type connector can be on the access device and the corresponding conventional female Luer type connector can be on the tubing set. In such a case, a conventional male Luer type connector can be used on the adapter 516 instead of the female Luer connector 513. Instead, the needle set 510 can be provided with a priming connector 550 shown in
After the needle set 510 has been used, it is typically discarded. Accordingly, it is typically a disposable item.
The needle set described above with reference to
In accordance with yet another aspect of the invention, a hemodialysis, or hemofiltration, catheter arrangement, which can be used selectively with non-conventional tubing sets, each of which is similar to the tubing set 518 shown in
In
The catheter 612 further comprises two tubular portions 620, 622. The tubular portions 620, 622 are operatively connected to the catheter portion 614 at a junction 617, such that the lumen 616 extends longitudinally along tubular portion 620, and the lumen 618 extends longitudinally along the tubular portion 622.
A non-conventional connector 514 is mounted on a free end of each of the tubular portions 620, 622. As described above, with reference to
An adapter 516, similar to the adapter described above with reference to
Use of the arrangement 610, in a relatively high blood flow hemodialysis, or hemofiltration, application, will now be described. In such a relatively high flow application, a non-conventional extracorporeal tubing set, similar to that indicated by reference numeral 518 in
Use of the arrangement 610 with conventional hemodialysis, or hemofiltration, tubing sets, will now be described. Each of the conventional tubing sets is similar to the tubing set shown in
A priming connector 550, as shown in
A non-conventional hemodialysis, or hemofiltration, tubing set arrangement, in accordance with another aspect of the invention, which can be used advantageously in hemodialysis, and/or hemofiltration, procedures, will now be described with reference to
The non-conventional tubing set arrangement is generally indicated by reference numeral 710 and comprises a non-conventional tubing set 518 similar to the tubing set 518 indicated in
The tubing set arrangement 710 further comprises an adapter 712. The adapter 712 includes a connector 714 complementary to the connector 522. In the case where the connector 522 is in the form of a non-conventional Luer, or Luer-like, male connector, the connector 714 is in the form of a complementary Luer, or Luer-like, female connector. The adapter 712 further comprises a conventional male Luer type connector 716, which corresponds to the conventional Luer type connectors currently used in hemodialysis, and hemofiltration, procedures.
The tubing set arrangement 710 can conveniently be supplied together with a hemodialysis, or hemofiltration, machine, or can be supplied separately for mounting on a hemodialysis, or hemofiltration, machine. Conveniently, the tubing set arrangement 710 can be supplied with the adapter 714 mounted on the connector 522. A cap 718, releasably mounted on the connector formation 716 can be provided to inhibit fouling of the tubing set arrangement when not in use.
In use, the tubing set arrangement 710 is operatively connected to a hemodialysis, or hemofiltration, machine, in conventional fashion. In the case where an access device having a conventional Luer type female connector is to be used to access the patient to perform a hemodialysis, or hemofiltration, procedure, the adapter 712 is retained in a mounted condition on the connector 522. The cap 718 is then removed to expose the conventional male Luer type connector 716. The connector 716 can then be connected to the conventional access device in conventional fashion so as to access the patient to perform a hemodialysis, or hemofiltration, procedure.
In the case where a non-conventional access device, having a non-conventional connector, such as the connector 514 shown in
Although the arrangement 710 can be formed to be reusable, it is preferably of a disposable type. Thus, after a procedure has been performed, the arrangement 710 is typically discarded.
A priming connector 810, shown in
Although the foregoing invention has been described in some detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that certain changes and modifications may be practiced within the scope of the appended claims.
The present application is a divisional patent application claiming priority from U.S. patent application Ser. No. 09/563,674, filed on May 2, 2000, the full disclosure of which is incorporated herein by reference. This patent application is also related to U.S. patent application Ser. Nos. 08/896,790; 08/896,592; and 08/896,791, all of which were filed on Jul. 18, 1997, the full disclosures of which are incorporated herein by reference.
Number | Date | Country | |
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Parent | 09563674 | May 2000 | US |
Child | 12128547 | US |