Antimicrobial ultraviolet irradiation of connector for continuous ambulatory peritoneal dialysis

• US 4,412,834 A
• Filed: 06/05/1981
• Issued: 11/01/1983
• Est. Priority Date: 06/05/1981
• Status: Expired due to Term

• Current Assignee: Baxter Travenol Laboratories Incorporated
• Original Assignee: Baxter Travenol Laboratories Incorporated
• Inventors: Popovich, Robert P., Moncrief, Jack W., Stauber, Ronald C., Kulin, Ralph
• Primary Examiner(s): Pellogrino, Stephen C.
• Application Number:
  US06/270,743
• Time in Patent Office: 879 Days
• Field of Search: 128/213, 128/214, 128/214.2, 128/214.6, 128/274, 128/675, 285/3, 250/455, 222/83, 137/625.41, 604/905, 604/29, 604/283, 604/103
• US Class Current: 604/29
• CPC Class Codes: A61M 1/1674 using UV radiation sources for sterilising the dialysate
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 2039/1083 having a plurality of female connectors, e.g. Luer connectors
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable
• CPC Class Codes: Y10T 137/86823 Rotary valve

Abstract

A connector valve for selectively permitting the transfer of fluids therethrough is described. Multiple-way valve means communicates with a plurality of conduits and selectively permits and prevents flow between the conduits. The multiple-way valve means comprises outer walls made of a substantially ultraviolet-transmissive material, with the outer walls of the multiple-way valve means preferably enclosing an elastomeric seal member defining rotatable channel means for communication with differing conduits at differing rotational positions, and also providing a rotatable seal against inner surfaces of the outer walls to maintain an antimicrobial seal of said conduits. The channel means is exposed along its entire length to an inner surface of an outer wall, to facilitate the antimicrobial effect of ultraviolet radiation. Also, a novel method of practicing continuous ambulatory peritoneal dialysis, and an ultraviolet light applicator, is disclosed.

Claims

1. A connector valve for selectively permitting the transfer of fluids therethrough, which comprises multiple-way valve means communicating with a plurality of conduits and selectively permitting and preventing flow between the conduits;

said multiple-way valve means comprising outer walls made of substantially ultraviolet-transmissive material;

said outer walls of the multiple-way valve means enclosing an elastomeric seal member, said seal member defining rotatable flow channel means for communication with differing conduits at differing rotational positions and providing rotatable seal means against inner surfaces of said outer walls to maintain antimicrobial conditions within said valve, said flow channel means being exposed along its entire length to an inner surface of an outer wall, and means for relatively rotating said seal member relative to said conduits.

2. The connector valve of claim 1 in which at least two of said conduits carry at their ends threaded means for receiving and fixedly retaining couplers for connection to fluid containers.

3. The connector valve and coupler means of claim 1 in which the outer walls are made of quartz.

4. The connector valve and coupler means of claim 1 in which the outer walls are made of a fluorocarbon material.

5. A connector valve for selectively permitting the transfer of fluids therethrough, which comprises multiple-way valve means communicating with a plurality of conduits and selectively permitting and preventing flow between said conduits, said multiple-way valve means comprising outer walls made of substantially ultraviolet-transmissive material, said outer walls of the multiple-way valve means enclosing rotatable flow channel defining means for communicating with differing rotational positions and providing rotatable seal means against inner surfaces of said outer walls to maintain antimicrobial conditions within said valve, the flow channel defined by the flow channel defining means being exposed along its entire length to an inner surface of an outer wall, and means for rotating said seal member relative to said conduits, at least one of said conduits carrying at its end threaded means for receiving and fixedly retaining coupler means connected to fluid containers;

said coupler means being threadedly and in sealingly interlocked relation with said conduits, said coupler means projecting into said threaded conduits and defining frangible means preventing flow through said coupler means, said frangible means being openable to permit flow without disconnection from said conduits, the exposed, outer surfaces of said coupler means positioned within said conduits being positioned for exposure to ultraviolet light passing through said valve means, said frangible means preventing flow being a diaphragm positioned at the end of said coupler means within each conduit and spaced from the threads of said coupler means and conduits for easy exposure of its outer surface to ultraviolet light passing through said valve means, and spike means positioned within said coupler means capable of being manually moved from the exterior to puncture said diaphragm after exposure to a sufficient quantity of ultraviolet light to have maximum antimicrobial effect.

6. The connector valve and coupler means of claim 5 in which one conduit is free of said threaded means and is in flow communication with an indwelling peritoneal catheter of a patient.

7. The connector valve and coupler means of claim 5 in which said coupler means is substantially opaque to ultraviolet light.

8. The connector valve and coupler means of claim 5 in which the wall defining threads of said conduit is thinner than the wall defining threads of the coupler means.

9. The connector valve and coupler means of claim 5 in which said spike defines a cut-away portion at its sharpened end, said sharpened end defining a pointed edge at one side of the spike opposed to said cut-away portion, whereby the diaphragm is not cut away from the coupler means at the area adjacent the cut-away portion and retains its attachment thereto.

10. The connector valve and coupler means of claim 5 in which stop means are carried by said coupler means to prevent overadvancement of the coupler means into said conduits and stripping the respective threads.

11. The connector valve and coupler means of claim 5 in which said coupler means defines bellows means for longitudinal collapse of said coupler means and means for advancing said spike upon said collapse.

12. The connector valve and coupler means of claim 5 in which said flow channel defining means includes an elastomeric seal member defining said rotatable flow channel means.

13. A connector valve for selectively permitting the transfer of fluids therethrough, which comprises multiple-way valve means communicating with a plurality of conduits and selectively permitting and preventing flow between said conduits, said multiple-way valve means comprising outer walls made of a substantially ultraviolet transmissive material, at least two of said conduits removably receiving couplers connected with fluid containers, and means for fixedly but removably retaining said couplers in communication with said conduits, each of said couplers carrying frangible means preventing flow through said couplers, said frangible means being openable to permit fluid flow without disconnection from said conduits, the outer surfaces of said couplers positioned within the conduits to receive antimicrobial irradiation by ultraviolet light passing through said valve means, said frangible means preventing flow being a diaphragm positioned at the end of said couplers within each conduit for exposure of its outer surface to ultraviolet light passing through said valve means for antimicrobial irradiation, and spike means positioned within said couplers capable of being manually moved from the exterior to puncture said diaphragm after irradiation.

14. The connector valve and couplers of claim 13 in which each conduit is capable of receiving a coupler means, and each coupler means, is tapered to provide a luer-type seal, said conduit and coupler means each defining removably interengaged threads for retention with each other.

15. The connector valve and couplers of claim 14 in which one conduit is free of said threaded means and is in flow communication with an indwelling peritoneal catheter of a patient.

16. The connector valve and couplers of claim 14 in which the area defining threads of said conduit is thinner than the area defining threads of the coupler means.

17. The connector valve and couplers of claim 14 in which said spike defines a cut-away portion at its sharpened end, said sharpened end defining a pointed edge at one side of the spike opposite to said cut-away portion, whereby the diaphragm is not cut away from the coupler means when the spike punctures the diaphragm.

18. The connector valve and couplers of claim 14 in which stop means are carried by said coupler means to prevent overadvancement of the coupler means into said conduits and stripping of the respective threads.

19. The connector valve and couplers of claim 14 in which said couplers define bellows means carried thereon for longitudinal collapse of said couplers;

and means for advancing said spike upon said collapse to penetrate the diaphragm.

20. A connector valve for selectively permitting the transfer of fluids therethrough, which comprises multiple-way valve means communicating with a plurality of conduits and selectively permitting and preventing flow between said conduits, said multiple-way valve means comprising outer walls made of substantially ultraviolet-transmissive material, said outer walls of the multiple-way valve means enclosing rotatable flow channel defining means for communicating with differing rotational positions and providing rotatable seal means against inner surfaces of said outer walls to maintain antimicrobial conditions within said valve, the flow channel defined by the flow channel defining means being exposed along its entire length to an inner surface of an outer wall, and means for rotating said seal member relative to said conduits, at least one of said conduits carrying at its end threaded means for receiving and fixedly retaining coupler means connected to fluid containers;

said coupler means being threadedly and in sealingly interlocked relation with said conduits, said coupler means projecting into said threaded conduits and defining frangible means preventing flow through said coupler means, said frangible means being openable to permit flow without disconnection from said conduits, the exposed, outer surfaces of said coupler means positioned within said conduits being positioned for exposure to ultraviolet light passing through said valve means.

21. The method of performing peritoneal dialysis by draining spent peritoneal dialysis solution from, and then adding fresh peritoneal dialysis solution to, the peritoneal cavity of a patient being treated by peritoneal dialysis in a manner that decreases the likelihood of transmitting microbial comtamination to the peritoneal cavity of the patient, the method comprising the steps of:

(a) connecting a first access port of a first container filled with fresh peritoneal dialysis solution to a first connection port of a multiple-way valve means in communication with the patient'"'"'s peritoneal cavity, said first access port and first connection port being both sealed at their inner ends to prevent migration of bacteria in the direction of the peritoneal cavity;

(b) connecting a second access port of an empty container to a second connection port of said multiple-way valve means in communication with the patient'"'"'s peritoneal cavity, said second access port and second connection port being each sealed against migration of bacteria in the direction of the peritoneal cavity beyond a predetermined area, said predetermined area being spaced and sealed from the first access port and first connection port;

(c) flowing spent peritoneal dialysis solution from the patient'"'"'s peritoneal cavity through said second connection port and second access port into said empty container while simultaneously exposing at least said first connection port and first access port to a sufficient quantity of ultraviolet radiation that an antimicrobial effect is obtained thereon;

(d) closing said second connection port; and

then

(e) opening the seal between said first connection port and said first access port to flow fresh peritoneal dialysis solution from the first container into the patient'"'"'s peritoneal cavity via said multiple-way valve means.

22. The method of claim 21 in which said multiple-way valve means comprise outer walls made of a substantially ultraviolet-transmissive material and defining flow channel means through said multiple-way valve means which are exposed along the entire length thereof to an inner surface of an outer wall.

23. The method of claim 22 in which each container which is emptied as the peritoneal dialysis solution passes into the peritoneal cavity of the patient is retained in seal relation to a connection port of said conduit until the peritoneal dialysis solution is once again drained from the patient'"'"'s peritoneal cavity to said container.

24. The method of claim 22 in which, after peritoneal dialysis solution flows from said first container to the peritoneal cavity of a patient, the connection ports of said multiple-way valve means connected to said containers are sealed and said containers removed, and thereafter an empty container is attached to a connection port of said conduit, and the connection port is exposed to a sufficient quantity of ultraviolet radiation so that an antimicrobial effect is obtained upon said connection port, the seal of said connection port being then removed to permit spent peritoneal dialysis solution to flow from the patient'"'"'s peritoneal cavity to said newly attached container.

25. The method of performing peritoneal dialysis by draining spent peritoneal dialysis solution from, and then adding fresh peritoneal dialysis solution to, the peritoneal cavity of a patient being treated by peritoneal dialysis in a manner that decreases the likelihood of transmitting microbial contamination to the peritoneal cavity of the patient, the method comprising the steps of:

(a) connecting an access port of a first container filled with fresh peritoneal dialysis solution to a first connection port of a conduit in communication with the patient'"'"'s peritoneal cavity, said access port and first connection port being both sealed at their inner ends to prevent migration of bacteria in the direction of the peritoneal cavity;

(b) exposing said first connection port and first access port to a sufficient quantity of ultraviolet radiation so that an antimicrobial effect is obtained thereon;

(c) opening the seals between said access port and connection port to allow peritoneal dialysis solution to flow from the first container to the patient'"'"'s peritoneal cavity;

(d) connecting a second container filled with fresh peritoneal dialysis solution to a second connection port of a conduit in communication with the patient'"'"'s peritoneal cavity, said second access port and connection port being each sealed against migration of bacteria in the direction of the peritoneal cavity beyond a predetermined area, said predetermined area being spaced and sealed from the first access port and connection port;

(e) flowing spent peritoneal dialysis solution from the patient'"'"'s peritoneal cavity through said first connection port and access port into said empty container while simultaneously exposing at least said second connection port and access port to a sufficient quantity of ultraviolet radiation that an antimicrobial effect is obtained thereon;

(f) closing at least said first connection port; and

then

(g) opening the seal between said second connection port and said second access port to flow fresh peritoneal dialysis solution from the second container into the patient'"'"'s peritoneal cavity via said conduit, in which said first and second connection ports constitute part of multiple-way valve means for selectively opening and sealingly closing off flow communicating between said first and second connection ports and the conduit in communication with the patient'"'"'s peritoneal cavity, said multiple-way valve means comprising outer walls made of a substantially ultraviolet-transmissive material and defining flow channel means through said multiple-way valve means, said flow channel means being exposed along the entire length thereof to an inner surface of an outer wall.

26. The method of claim 25 in which each container which is emptied as the peritoneal dialysis solution passes into the peritoneal cavity of the patient is retained in sealed relation to a connection port of said conduit until the peritoneal dialysis solution is once again drained from the patient'"'"'s peritoneal cavity to said container.

27. The method of claim 25 in which, after peritoneal dialysis solution flows from said first and second containers to the peritoneal cavity of a patient, the connection port of said conduit connected to said container is sealed and said container removed, and thereafter an empty container is newly attached to a connection port of said conduit, and the connection port is exposed to a sufficient quantity of ultraviolet radiation so that an antimicrobial effect is obtained upon said connection port, the seal of said connection port being then removed to permit spent peritoneal dialysis solution to flow from the patient'"'"'s peritoneal cavity to said newly attached container.

28. A connector member for providing substantially aseptic connection between a peritoneal tube for connection with the peritoneal cavity of a patient and a dialysis solution container port tube, which connector member comprises:

a first coupler on one end of said peritoneal tube, a second coupler on the outer end of said container port tube, said first and second couplers being proportioned for sealing connection in telescoping relation while permitting fluid flow between the peritoneal tube and container port tube, the innermost of said couplers in telescoping relation being sealed at its outer end with a diaphragm, a spike member, one of said couplers surrounding said spike member, means for rendering said spike member manually advanceable to penetrate said diaphragm while the couplers are connected, said first and second couplers each defining mating screw threads for connection therebetween, said couplers each also defining, at portions axially spaced from said screw threads, tapered, tubular portions proportioned to sealingly fit together in telescoping relation, when the couplers are connected together, to form a luer-type seal, at least the coupler defining the outermost of said tapered, tubular portions in said telescoping relation being made of a material and a thickness to permit the substantial transmission of ultraviolet radiation from the exterior to the interior thereof for antibacterial effect in areas possibly exposed to contamination during the connection process.

29. The connector member of claim 28 in which bellows means are provided to facilitate manual penetration of the spike member through the diaphragm.

30. The connector member of claim 29 in which both tapered, tubular portions are made of ultraviolet transparent material to permit substantial transmission of ultraviolet radiation therethrough.

31. A coupler member for connecting one tube end with another by a connection with another mating coupler, said coupler member being carried on flow conduit means for medical solution for communication with a medical solution container, said coupler member defining a tubular body having screw threads for mating closure with the other coupler, and a tapered tubular portion axially spaced from said screw threads for sealing fit with a corresponding tapered tubular portion of the other coupler in a luer-type seal, said coupler being made of a material and a thickness to permit the substantial transmission of ultraviolet radiation from the exterior to the interior thereof.

32. The coupler member of claim 31 which surrounds a spike member and defines an outer end, and a diaphragm carried at said outer end.

33. The coupler member of claim 32 including a flexible bellows member carried thereon in which said flexible bellows member is provided to permit manual advancement of a spike member through the diaphragm.

34. The coupler member of claim 31 having an outer end, said tapered tubular portion axially spaced from the screw threads being positioned adjacent said outer end, said outer end being closed by a puncturable diaphragm.