WO1983002060A1

WO1983002060A1 - Ultraviolet sterilizable connector having spike with projecting vanes

Info

Publication number: WO1983002060A1
Application number: PCT/US1982/001503
Authority: WO
Inventors: Inc. Baxter Travenol Laboratories; Ralph Kulin
Original assignee: Baxter Travenol Lab
Priority date: 1981-12-10
Filing date: 1982-10-22
Publication date: 1983-06-23
Also published as: EP0096054A1; IT1154372B; ES8407396A1; IT8224525A0; ES518100A0; IT8224525A1

Abstract

A connector member (20, 22) includes a spike (32) having projecting vanes (34) within a substantially ultraviolet transmissive sleeve (20, 46). Fluid flows through the connector by passing between the vanes (34), the surfaces of which may be open, to be exposed to ultraviolet irradiation through the sleeve (20).

Description

ULTRAVIOLET STERILIZABLE CONNECTOR

HAVING SPIKE WITH PROJECTING VANES

Technical Field and Prior Art

Various types of peritoneal dialysis, particularly 5 continuous ambulatory peritoneal dialysis (CAPD) as dis¬ closed in Popovich et al. U.S. Patent No. 4,239,041, rep¬ resent a type of treatment of patients who have lost kidney function, for maintenance of life. Peritoneal dialysis techniques constitute an alternative route to 10 the currently more common hemodialysis technique, in which blood is passed through a dialyzer. In peritoneal dialy¬ sis, dialysis solution is passed into the peritoneal cavity with the membranes of that cavity serving as diffusion exchange members between the blood and the peritoneal l**-* dialysis solution.

As a particular advantage of continuous ambulatory peritoneal dialysis (CAPD) the patient is free from being tied to a machine throughout the day and night, and is capable of engaging in most normal activities. He only ²⁰ has to perform a relatively quick dialysis exchange approximately four or five times a day, to replace the solution in the peritoneal cavity.

Probably the most significant disadvantage of peri¬ toneal dialysis is the fact that the peritoneal cavity is ⁵ extremely subject to infection, known as peritonitis.

Thus, as the various exchanges of dialysis solution are performed throughout the day, every day, extreme care must be taken to prevent the entry of any microorganisms into the peritoneal cavity. In conventional procedures, a ⁰ stray breath, a piece of dust, a glancing touch, can all provide sufficient contamination of the connection which terminates the tube communicating with the peritoneal cavity to result in a case of peritonitis, which in many circumstances can be life threatening. 5 Various procedures have been proposed to minimize or eliminate the risk of contamination as connections are ade and broken between the peritoneal dialysis solution bags and the peritoneal tube of the patient. For example, a connection box in which ultraviolet light may be option¬ ally used as a sterilization means is shown in U.S. Patent 5 No. 4,242,310.

Furthermore, Kulin et al. Patent Application Serial No. 270,743, filed June 5, 1981, entitled "Antimicrobial Ultraviolet Irradiation of Connector for Continuous Ambu¬ latory Peritoneal Dialysis", shows an ultraviolet sterili- 0 zable connector system utilizing a hollow tubular spike and a frangible membrane. In the specific embodiment, the spike remains in an aseptically sealed condition by the membrane, since the bore of the spike cannot be easily sterilized by ultraviolet light, and so the spike itself **^** does not need ultraviolet sterilization after the connec¬ tion has been made, because it is sealed from contamina¬ tion. The need for sterilization is on the outside of the membrane, opposed from the spike, which is subject to contamination during connection with another coupler.

20 However, in many situations it is desirable for the spike to be in an unsealed configuration, with the membrane through which it penetrates being attached to the other coupler. Specifically, it may be desired for the spike to be reusable, being carried at the end of the patient's

25 peritoneal tube, while the other coupler carrying the piercable membrane or diaphragm is carried by each indi¬ vidual peritoneal dialysis solution container.

While piercing spikes having radially projecting vanes are known (as in U.S. Patents 3,796,218 and

30 4,195,632), the particular advantage of the use of such a spike in conjunction with an ultraviolet transparent, sterilizable system, so that all flow surfaces of the spike may be sterilized by ultraviolet light, has not been previously taught.

35 By this invention, a generally reusable spike-type, ultraviolet sterilizable coupler is provided in which the coupler can be worn by the patient for a period of weeks or so for receiving a continuous succession of connectors in communication with peritoneal dialysis solution bags, for the continuous maintenance of the patient by peri- toneal dialysis, combined with reliable sterilization of the connections as they are made, prior to permitting flow of dialysis solution through the connection.

By the term "sterilization" as used herein, the con¬ cept of substantial sterilization is intended to be in- eluded, in which the bacteria population is reduced to such a low level that the chances of significant infection of the patient are significantly reduced or eliminated.

Description of the Invention

By this invention, a connector member for providing substantially aseptic connection between typically a peritoneal tube for connection with the peritoneal cavity of a patient, and a dialysis solution container port tube is provided. The connector member may, of course, be used for other purposes as well, as may be desired. A first coupler is provided on one end of the peri¬ toneal tube, and a second coupler is provided on the outer end of the container port tube. The first and sec¬ ond couplers are proportioned for sealing connection together while permitting fluid flow between the peri- toneal tube and the container port tube.

At least one of the couplers are sealed at its outer end with a diaphragm. A spike member is positioned to extend through one of the couplers and is movable to pene¬ trate the diaphragm once the couplers are connected. The material of the coupler through which the spike member extends prior to penetrating the diaphragm is substan¬ tially ultraviolet transmissive, to permit substantial antibacterial effect on the interior and also the outside surface of the diaphragm and other nonsterile areas prior to puncture of the diaphragm.

OMPI

V_Λ, WPO If desired, the spike member has a plurality of radially extending longitudinal vanes for guiding liquid flow therealong. The spike member is positioned to be advanceable through the diaphragm, and is also positioned ⁵ to permit irradiation of all exposed surfaces of at least the forward portion of the spike by ultraviolet radiation passing through the material of the coupler.

Typically the coupler which carries the sealed diaphragm is the other coupler from the one through which

I" the spike member extends prior to penetrating the diaphragm. Thus the spike, which may be repeatedly used throughout the course of a few weeks, may become nonsterile between dialysis solution exchange treatments, and thus is ster¬ ilized by exposure to the ultraviolet radiation passing

I⁵ through the material of the coupler prior to breaking through the diaphragm. The spike is preferably solid, i.e., has no bore, and comprises at least three of the radially extending vanes. Thus the flow surf ces along the spike, defined between the vanes, are all exposable

20 to ultraviolet light so that the spike can be sterilized, contrary to a hollow tubular spike design in which the bore would be ultraviolet sterilizable only with diffi¬ culty.

The coupler through which the spike is advanced is

25 desirably connected to a tubular bellows member to permit the advancement and retraction of the coupler relative to the spike member. The bellows member may be made of a material and of a thickness to permit the substantial transmission of ultraviolet radiation into its interior,

30 for sterilization of that area of the spike which it sur¬ rounds, as well as the area of the spike which penetrates the coupler member itself.

In this design, the spike member itself may be made of a material substantially opaque to ultraviolet radia-

35 tion, since flow-contacting surfaces of the spike are exposed to the exterior, and ultraviolet light does not have to penetrate the spike. Thus the material selected for the spike can instead have good bonding characteris¬ tics, with the spike being positioned to extend through the first coupler, and being sealed to a portion of the ^•*-^* peritoneal tube in a manner permitting liquid flow there¬ through. For eχa.mple the outer edges of the rear segments of the vanes may carry a sealing sleeve for sealing to the rest of the tube, with the spike material being selected so that this sealing step is easy and reliable. -^*-^••• The bellows may also be sealed in the same area, to permit the axial extending and shortening of the bellows for ad¬ vancement and retraction of the connected couplers rela¬ tive to the spike, so that the spike can penetrate the diaphragm. The projecting vanes of the spike cause radial I^*-^* cuts to be formed in the diaphragm, which permits the diaphragm from accidentally blocking flow after it has been penetrated.

By the term "substantially ultraviolet transmissive material", it is implied that the material of at least 20 the connector, and preferably also the bellows, should preferably be made of a material and of a thickness so that at least 10 percent of the ultraviolet radiation to which it is exposed penetrates to the interior. Examples of such ultraviolet transmissive material include poly- 5 chlorotrifluoroethylene and related polymers, polyolefins, and also pol (ethylene-acrylic acid) salts with cations such as alkaline metals, alkaline, earth and zinc. Such copolymers are commercially available from DuPont under the trademark SURLYN. Likewise, low density polyethylene 0 or poly(ethylene-vinyl acetate) polymers may be used, as well as other materials having ultraviolet trans issivity.

The spike itself may be made of a material such as an ultraviolet-opaque or other material as desired, for example ABS plastic or other styrene-containing plas- 5 tics.

__OMPI _ Alternatively, rigid polyvinyl chloride formulations or polyolefins such as polypropylene may be used for the spike.

It may be desirable for the spike to be made of a hydrophobic material, for example, a plastic having a high styrene content, to prevent the formation of liquid films along the surface of the spike when the connector is drained of liquid, to interfere with the migration of the bacteria along the spike after the connector has been 0 opened and during the ultraviolet sterilization cycle.

Brief Description of Drawings

Figure 1 is a schematic view of a peritoneal dialysis procedure being performed in accordance with this inven¬ tion, during the period that spent peritoneal dialysis 5 solution is passing from the patient's peritoneal cavity to a solution bag.

Figure 2 is another schematic view of the apparatus of this invention in which a bag of fresh peritoneal dialy¬ sis solution is connected to a peritoneal tube and is in 0 the process of being sterilized by ultraviolet light.

Figure 3 is a schematic view of the structure of Figure 2, subsequent to the ultraviolet sterilization step, in which the flow path between the bag and the peritoneal cavity is opened, and fresh peritoneal dialysis solution **** is allowed to flow into the peritoneal cavity.

Figure 4 is a magnified longitudinal sectional view of the connection site of the apparatus as shown in Fig¬ ure 2.

Figure 5 is a longitudinal sectional view similar to 0 Fig re 4, but showing the spike in advanced, diaphragm- rupturing relation.

Figure 6 is a longitudinal sectional view of the connection site between segments of the apparatus of Figures 2, but showing a different embodiment. 5 Figure 7 is a sectional view taken along line 7-7 of Figure 6. Description of Specific Embodiments

Referring to Figure 1, a peritoneal dialysis system is disclosed in which a peritoneal catheter 10, for example a Tenckhoff catheter of the indwelling type, resides in 5 the peritoneal cavity 12 of a patient. A tubular peri¬ toneal set 14 communicates with catheter 10 by means of conventional connectors 16, 18 respectively on the ends of set 14 and catheter 10. Peritoneal sets may typically be connected to catheter 10 on about a monthly basis, with 0 professionally trained technicians doing the connection in a hospital or clinic, as is current conventional prac¬ tice in CAPD

Peritoneal tube 14 is then terminated with a first coupler 20, which is shown to be in sealing communication 5 with a second coupler 22, which communicates through tub¬ ing 24 with a peritoneal dialysis solution bag 26.

Slide clamps 27, 28 or clamps of another type, are provided to control flow through the system.

In Figure 1, the specific situation is shown at the ⁰ end of the so called "dwell" period, in which the peri¬ toneal dialysis solution has resided for a period of hours in the peritoneal cavity. The patient lowers the bag with respect to the peritoneal cavity. Slide clamps 27, 28 are then opened, to permit the solution to pass from the peri- **** toneal cavity 12 into bag 26.

Thereafter, as shown in Figure 2, bag 26 is removed • by the disconnection of couplers 20, 22, and a fresh bag 26a of peritoneal dialysis solution is provided, being connected through tubing 24a to another coupler 22a, which is connected with coupler 20.

First coupler 20 may be made of a zinc salt of poly¬ ethylene acrylic acid) which is commercially available as stated above. Second coupler 22a may be made of a block copolymer sold by DuPont as Hytrel, or another plastic material.

At this point, there is the possibility that contam¬ ination has entered the system, residing in or between couplers 20 and 22a, so, if desired, the freshly joined couplers 20, 22a may be placed in an ultraviolet box 30 as in Figure 2 for application of ultraviolet light to the system for sterilization of the connection between the two 5 couplers and adjacent interior areas. Clamp 28 and also optionally clamp 27 are closed during this process, to prevent flow.

Following the ultraviolet application step, bag 26a is elevated; clamps 27, 28 are opened; and the fresh periton-

10 eal dialysis solution is allowed to flow from bag 26a to the peritoneal cavity 12.

Ultraviolet box 30 may be of any suitable design in which ultraviolet emission lamps irradiate the entire surface and nonsterile interior of the two couplers, for

15 reliable sterilization of the system prior to flow of the peritoneal dialysis solution.

Figure 4 is an enlarged longitudinal sectional view of couplers 20 and 22a showing the structure of the inven¬ tion which provides ultraviolet sterilization capability

² to the system. As shown, peritoneal tube 14, carrying slide clamp 28, communicates with a sleeve 38 which may be an integral part of spike 32. Spike 32 carries a plurality of radially extending longitudinal vanes 34, sleeve 38 and vanes 34 being preferably an integrally

²5 molded piece defining spike 32, with vanes 34 meeting at the central axis of the spike. Sleeve 38 is attached to and carried by the outer ends of vanes 34 at junction lines 40, so that flow channels 43 are defined through sleeve 38, between vanes 34.

^***° Spike 32 may be made of an integrally molded single piece and out of a plastic material which is sealingly compatible with the material of peritoneal tube 14. For example, the peritoneal tube 14 may be made of poly- vinyl chloride plastic, and spike member 32 may be made

35 of an appropriate preferably hydrophobic plastic which may be solvent sealed, for example to tubing 14 through sleeve 38. First coupler 20 may also be made of a single tubular piece of ultraviolet transmissive material, defining a forward section 42 having internal screw threads 44, and a rear bellows section 46, to permit forward section 42 to be advanced and retracted with respect to spike 32. The rear tubular section 48 of first coupler 20 may be sealed to sleeve 38 in any manner desired, and/or, as shown herein, a spring steel compression ring 50 may be added to provide a pressure seal between tubular end 48 and sleeve 38.

Second coupler 22a defines a pierceable diaphragm 52 at its forward end and a tapered tubular luer portion 54 which is adapted to provide a luer type seal with tapered socket area 56 of first coupler 20, when connected as shown in Figure 4. Second coupler 22a also defines screw threads 58 which mate with screw threads 44 of first coupler 20. Screw threads 44, 58 are positioned to be axially spaced from luer section 54 so that the luer section 54 in its mating relation with section 56 can be exposed to ultraviolet light passing through section 56 without intereference from the thicker screw thread sec¬ tions 44, 58.

Second coupler 22a may then be connected to tubing 24a which connects with bag 26a as previously described. While coupler 20 must be made of an ultraviolet transmissive material in accordance with this invention, second coupler 22a in the specific embodiments shown does not have to be made of an ultraviolet transmissive mater¬ ial, but instead may be made of any desired plastic ma- terial.

Specifically, second coupler 22a which carries dia¬ phragm 52 is sealed, and may be sterilized at the factory in its interior, so that only its exterior portions adja¬ cent the connection site need to be sterilized. Thus it does not have to be ultraviolet transmissive. First coupler 20, however, may be intended for reuse, and is an open system which requires ultraviolet transmissive

OMPI materials so that the interior surfaces including at least the forward portion of spike 32 may be sterilized.

Referring to Figure 5, after the sterilization step illustrated in Figure 2 has been performed, coupler 20 5 may be inserted by the folding of bellows member 46 to cause spike 32 to penetrate diaphragm 52 of coupler 22a. The system interior is now sterile by the irradiation of the ultraviolet light on the outer surface of diaphragm 52, the inner surfaces of coupler 20, and the exposed

10 surfaces of spike 32 which, contrary to a tubular spike, are more available for irradiation by ultraviolet light through coupler 20. Accordingly, fluid can now flow as in Figure 3 from bag 26a through second coupler 22a, first coupler 20, along the flow channels 60 defined between

^•*-5 vanes 34 of spike 32, and into peritoneal tubing 14 for conveyance to the peritoneal cavity 12.

Referring to Figure 6, a system which is similar to that of Figures 4 and 5 as shown, with the exceptions des¬ cribed below. In this embodiment, a second coupler 22a

20 similar to the previous design is shown coupled to a first coupler 20a, which is a two-piece coupler. Forward portion 62 of coupler 20a may be made of a fluorinated polymer such as polychlorotrifluoroethylene (sold under the trade¬ mark KEL-F) , which is sealed to a tubular bellows member

25 64 at projecting sleeve 66. Bellows member 64 may be made of a different material which has better flexibility, and thus is more suitable for use as a bellows member, for example one of the SURLYN polymers as described above. The remaining structure of the apparatus may be

30 identical to the previous equipment. Spike 32a and vanes 34a may be identical in construction to spike 32 and vanes 34, and peritoneal tube 14a, sleeve 38a, and ring 50a may be identical to their counterparts in the previous embodiment.

35 As shown in Figure 7, it is preferred for spike 32a

(and spike 32) to have three vanes 34a (or vanes 34) which are approximately equidistantly spaced from each other circumferentially, to provide angles from each other of about 120 . While more vanes than that may be used if desired, the use of three vanes provides larger obtuse (120 ) angles of spacing, which simplifies the problem of making sure that all portions of the exposed surface of spikes 32 and 32a are exposed to ultraviolet radiation. If four or more vanes are used, the problem may be increased that some portions of the exposed surface may be shadowed and concealed from direct exposure to ultraviolet light.

Accordingly, a connection system is provided in which a first coupler may be intended for reuse by the patient, being carried on the end of a peritoneal tube, carrying a spike member for puncturing the diaphragms on the ends of second couplers as they are presented. The interior of the first coupler, including the spike, is ultraviolet sterilizable, with the spike being preferably made of a hydrophobic material to prevent the formation of liquid films, through which bacteria might migrate inwardly a distant sufficient to escape the ultraviolet irradiation. By this system, the incidence of peritonitis in peritoneal dialysis procedures can be greatly reduced and even elimin¬ ated if proper procedure is followed.

If desired, the patient can remove coupler 22a and cap coupler 20 or 20a with a conventional sealing cap dur¬ ing the dwell period of peritoneal dialysis. When it is desired to drain, the cap may be removed and the bag connection may be made, followed by sterilization by ultraviolet irradiation, if desired, and flowing of the spent peritoneal dialysis solution into the container. Then, if desired, a fresh bag of peritoneal dialysis solution may be connected. Sterilization by ultraviolet radiation once again is provided, and the fresh peritoneal dialysis solution flows through the system into the peritoneal cavity. However, numerous other procedures for performing peritoneal dialysis may be also used with the connection of this invention. The above has been offered for illustrative purposes only, and is not intended to limit the scope of the in¬ vention of this application, which is as defined in the claims below.

Claims

THAT WHICH IS CLAIMED IS:

1. A connector member for providing substantially aseptic connection between a tube for connection and a solution container port tube, which connector member com- prises: a first coupler on one end of said tube for connec¬ tion, a second coupler on the outer end of said container port tube, said first and second couplers being propor¬ tioned for sealing connection together while permitting fluid flow between said tube for connection and container port tube, at least one of said couplers being sealed at its outer end with a diaphragm, and a spike member posi¬ tioned to extend through one of said couplers and movable to penetrate said diaphragm when the couplers are con- nected, the material of the coupler through which the spike member extends prior to penetrating said diaphragm being substantially ultraviolet transmissive to permit substan¬ tial antibacterial effect of the interior, including the outside surface of the diaphragm, said spike member being lumen free, said spike member being positioned to be ad- vancable through said diaphragm and also positioned to permit irradiation of all surfaces of at least the forward portion of the spike by ultraviolet radiation passing through said material of the coupler.

2. The connector member of Claim 1 in which said spike member is solid and comprises a plurality of radially extending longitudinal vanes for liquid flow therealong.

3. The connector member of Claim 2 in which the coupler through which said spike is advanced is connected to a tubular bellows member to permit the advancement and retraction of said coupler relative to the spike member, said bellows member being made of a material and

OMPI of a thickness to permit the substantial transmission of ultraviolet radiation into its interior.

4. The connector member of Claim 3 in which said spike member is made of a hydrophobic material having good bonding characteristics, said spike member being positioned to extend through said first coupler and being sealed to said peritoneal tube in a manner permitting liquid flow therethrough, said bellows being also sealed thereto to permit the axial extending and shortening of said bellows for advancement and retraction of said connected couplers relative to the spike.

5. The connector member of Claim 1 in which the coupler which carries the sealed diaphragm is the other coupler from the one through which the spike member ex- tends prior to penetrating said diaphragm.

6. A tube and coupler system for the flow of solution and for substantially aseptic connection which comprises a first coupler on one end of said tube, and a spike mem¬ ber within said tube positioned to extend through said first coupler and to penetrate a diaphragm preventing flow between said first coupler and a second coupler when in sealing, removably connected relation therewith, the material of at least said first coupler being substantially ultraviolet transmissive to permit substantial antibac- terial effect of the junction between said connected couplers and said spike member upon ultraviolet irradia¬ tion, said spike member being a structure having a plura¬ lity of radially extending longitudinal vanes, positioned to be advanced through said diaphragm, and also positioned to permit irradiation of all surfaces of at least the for¬ ward portion of the spike by ultraviolet irradiation passing through the material of the coupler.

7. The tube and coupler of Claim 6 in which at least a portion of said tube adjacent the coupler is also made of substantially ultraviolet transmissive material, to permit further antibacterial effect on said spike and the interior of said tube upon ultraviolet irradiation.

8. The tube and coupler of Claim 6 in which said spike member is solid and comprises three of said vanes.

9. The tube and coupler of Claim 6 in which said first coupler is connected to a tubular bellows member to permit the advancement and retraction of said coupler relative to the spike member.

10. The tube and coupler of Claim 9 in which said bellows member is made of a material and is of a thickness to permit the substantial transmission of ultraviolet irradiation into its interior for substantial antibacterial effect on said spike and the bellows interior.

11. The tube and coupler of Claim 10 in which said spike is made of a hydrophobic material having good bonding characteristics, said spike being sealed to said tube, said bellows being also sealed thereto to permit the axial extending and shortening of said bellows for advancement and retraction of said first coupler relative to the spike.

12. The tube and coupler of Claim 6 which is free of a diaphragm occluding its bore, and proportioned for con- nection with a coupler which carries a diaphragm for pene¬ tration by the spike.

13. The tube and coupler of Claim 12 which is con¬ nected to a peritoneal catheter.

14. The tube and coupler of Claim 13 in which said

OMPI first coupler comprises pol (chlorotrifluoroethylene) .

15. The tube and coupler of Claim 14 in which said bellows is made of a poly(ethylene-acrylic acid) salt with cations selected from the group consisting of alkal;' metal, alkaline earth, and zinc cations.

16. A connector member for providing substantially aseptic connection between a peritoneal tube, for connec¬ tion with the peritoneal cavity of a patient, and a dialy¬ sis 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 positioned for sealing connection together while permitting flow between said peritoneal tube and container port tube, one of said couplers being sealed at its outer end with a diaphragm, and a spike member positioned to pass through one of said couplers to penetrate said diaphragm when the couplers are connected, the material of at least the coupler through which the spike member extends prior to penetra¬ ting the diaphragm being substantially ultraviolet trans¬ missive to permit substantial sterilization of the in¬ terior, including the spike member and the outside surface of the diaphragm, said spike member being a solid, elon- gated member comprising at least three radially extending, longitudinal vanes for liquid flow therealong, the coupler through which said spike is advanced being connected to a peritoneal tube portion which permits the advancement and retraction of said coupler relative to the spike mem¬ ber, said peritoneal tube portion being made of a material and of a thickness to permit the substantial transmission of ultraviolet radiation into its interior, said spike member being positioned to be advanced through said dia¬ phragm, and also positioned to permit irradiation of all exposed surfaces of at least the forward portion of the spike by ultraviolet radiation passing through said ma¬ terial of the coupler and peritoneal tube portion.

17. The connector member of Claim 16 in which the coupler which has the sealed diaphragm is the other coupler from the one through which the spike member extends prior to penetrating the diaphragm.

18. The connector member of Claim 17 in which said spike is made of a hydrophobic material having good bonding characteristics, said spike being positioned to pass through said first coupler and being bonded to said peri¬ toneal tube in a manner permitting liquid flow there¬ through, a portion of said peritoneal tube being a bellows which is also bonded to said spike and a point of the peritoneal tube spaced from the first coupler, to permit the axial lengthening and shortening of said bellows for advancement and retraction of said connected couplers relative to the spike.

19. The connector member of Claim 18 in which the material of the coupler through which the spike extends comprises poly(chlorotrifluoroethylene) .

20. The coupler of Claim 19 in which the bellows is made of a poly(ethylene-acrylic acid) salt with cations selected from the group consisting of alkali metal, alka¬ line earth, and zinc cations.

21. A tube for the flow of solution and for substan¬ tially aseptic connection which comprises a first coupler on one end of said tube, and a spike member within said tube positioned to pass through said coupler to penetrate a diaphragm preventing flow between said first coupler and a second coupler when positioned in sealing, connected relation therewith, the material of at least said first coupler being substantially ultraviolet transmissive to permit substantial sterilization of the junction between said connected couplers and said spike member, said spike member being a solid member comprising at least three radially extending, longitudinal vanes and positioned to be advancable through said diaphragm, said spike member being also positioned to permit irradiation of all exposed surfaces of at least the forward portion of the spike member by ultraviolet irradiation passing through the material of the coupler, at least a portion of said tube adjacent said coupler being also made of substantially ul¬ traviolet transmissive material to permit substantial antibacterial effect on said spike and the interior of the tube.

22. The tube and coupler of Claim 21 in which said first coupler is connected to a tubular bellows member as a part of said tube, to permit the advancement and retrac¬ tion of said coupler relative to the spike member.

23. The tube and coupler of Claim 22 in which said bellows member is made of a material and is of a thickness to permit the substantial transmission of ultraviolet irradiation to its interior for substantial antibacterial effect on said spike and the bellows interior.

24. The tube and coupler of Claim 23 in which said spike is made of a hydrophobic material having good bond¬ ing characteristics, said spike being bonded to said tube, said bellows being also bonded to at least one of said spike and the remainder of said tube, to permit the axial extending and shortening of said bellows for advancement and retraction of said first coupler relative to the spike.

25. The tube and coupler of Claim 24 which is free of a diaphragm occluding its bore, and proportioned for connection with a coupler which carries a diaphragm for penetration by the spike.

26. The tube and coupler of Claim 25 in which said coupler is made of poly(chlorotrifluoroethylene) .

27. The coupler of Claim 26 in which said bellows is made of a poly(ethylene-acrylic acid) salt with cations selected from the group consisting of alkali metal, alka- line earth, and zinc cations.

28. The connector member of Claim 16 in which said spike is made of a hydrophobic material.

29. The tube and coupler of Claim 6 in which said spike member is made of a hydrophobic material.

30. A connector member for providing substantially aseptic connection between a peritoneal tube for connec¬ tion 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, one of said couplers surrounding a spike mem¬ ber which is manually advanceable to penetrate said dia¬ phragm 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,