Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M2039/1066—Tube connectors; Tube couplings having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath

Definitions

• 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.
• 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.
• 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.
• peri ⁇ toneal dialysis 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.
• 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.
• 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.
• the spike 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
• a generally reusable spike-type, ultraviolet sterilizable coupler 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.
• sterilization 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.
• 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.
• 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.
• 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.
• the coupler which carries the sealed diaphragm is the other coupler from the one through which
• the spike member extends prior to penetrating the diaphragm.
• 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
• the spike is preferably solid, i.e., has no bore, and comprises at least three of the radially extending vanes.
• the coupler through which the spike is advanced is
• the bellows member may be made of a material and of a thickness to permit the substantial transmission of ultraviolet radiation into its interior
• the spike member itself may be made of a material substantially opaque to ultraviolet radia-
• 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.
• 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.
• substantially ultraviolet transmissive material 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.
• 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.
• rigid polyvinyl chloride formulations or polyolefins such as polypropylene may be used for the spike.
• the spike may 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.
• a hydrophobic material for example, a plastic having a high styrene content
• 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.
• Figure 7 is a sectional view taken along line 7-7 of Figure 6. Description of Specific Embodiments
• a peritoneal dialysis system 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.
• 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.
• bag 26a is elevated; clamps 27, 28 are opened; and the fresh periton-
• 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
• 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
• 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
• *** ° 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.
• the peritoneal tube 14 may be made of poly- vinyl chloride plastic
• spike member 32 may be made
• 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.
• 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.
• 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
• coupler 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
• 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
• 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.
• vanes 34a or vanes 34
• 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.
• a connection system 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.
• 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.
• the cap 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.
• 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.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Epidemiology (AREA)
• Pulmonology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• External Artificial Organs (AREA)
• Apparatus For Disinfection Or Sterilisation (AREA)
• Physical Water Treatments (AREA)

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• 1982
  • 1982-10-22 WO PCT/US1982/001503 patent/WO1983002060A1/en unknown
  • 1982-10-22 EP EP82903556A patent/EP0096054A1/en not_active Withdrawn
  • 1982-11-30 IT IT24525/82A patent/IT1154372B/it active
  • 1982-12-10 ES ES518100A patent/ES518100A0/es active Granted

Non-Patent Citations (1)

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