CA1193984A - Antibacterial protective cap for connectors - Google Patents

Antibacterial protective cap for connectors

Info

Publication number
CA1193984A
CA1193984A CA000427025A CA427025A CA1193984A CA 1193984 A CA1193984 A CA 1193984A CA 000427025 A CA000427025 A CA 000427025A CA 427025 A CA427025 A CA 427025A CA 1193984 A CA1193984 A CA 1193984A
Authority
CA
Canada
Prior art keywords
protective cap
connector
chamber
cap
absorbent material
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000427025A
Other languages
French (fr)
Inventor
Vince Genatempo
Frank Karrasch
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter Travenol Laboratories Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter Travenol Laboratories Inc filed Critical Baxter Travenol Laboratories Inc
Application granted granted Critical
Publication of CA1193984A publication Critical patent/CA1193984A/en
Expired legal-status Critical Current

Links

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
    • A61M39/162—Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16—Biologically active materials, e.g. therapeutic substances
    • 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
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/106—Halogens or compounds thereof, e.g. iodine, chlorite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/202—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with halogen atoms, e.g. triclosan, povidone-iodine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00—Surgery
    • Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

Abstract of the Disclosure An article of manufacture and a method are pro-vided where a protective cap (10) for a connector (32) provides antibacterial effect to the connector (32) by fixedly lining a chamber (28) of the protective car (10) with an absorbent material (24) retaining an antiseptic. By mating a skirt (8) on the protective cap (10) with a corresponding flange (36) on a medical connector (32), a contamination proof seal is also provided which functions to limit contamination from the outside of the cap (10) and retain a liquid anti-septic on the inside of the cap (10).

Description

'P ~ 6~ ~3 A'~

ANTIBACTERIAL PROTECTIV~ CAP
FO~ COMNECTORS

Field of the ~nvention This invention relates to protectlve caps for medical connectors or ports and to closure systems for the ends of medical tubing or for ports on medical ap-paratus. The invention particularly relates to a pro-tective cap for a medical connector or medical port opening which provides an antibacterial effect. An improvement of the present invention lies in reliably providing an antibacterial effect to a connector or port opening.

Background of the Invention ~ypical medical connectors in wide use are con-nectors for solution containers, administration setsand catheters. Medical procedures require a connection where the bioburden (i.e. bacterial population) is minimi2ed. Protective caps conta:ining an antibacterial agent can reduce the bioburden by providing a bacterio cidal or bacteriostatic effect to connector sites prior to use. A protective cap having an antibacterial effect is particularly desirable for components used in peri-toneal dialysis, for example CAPD.
At the present time thousands of patients who have limited or nonexistent kidney function due to end state renal disease are being maintained by CAPD, and other fo~ms of peritoneal dialysis.
In the CAPD procedure, connections between dialysis solution containers and administration sets which commu-nicate with the peritoneal catheter must be made andbro~en, normally several times a day. Particularly when the patient is doing his own CAPD exchanges, there is ~3~

-- 2 ~
the possibility that the sterility of the flow path be-tween the various solution containers and the peritoneal cavity may be compromlsed. Airborne bacteria or the accidental contamination of an open connector by the patient can contaminate the flow path. The result of such a contamination can be peritonitis.
It is desirable to provide a protective cap for medical connectors such as CAPD connectors in particu-lar, which securely receive and provide an antibacterial effect to the connector. For example, the Quinton Cap manufactured by Quinton Instrument Co., is sold, which contains liguid antiseptic such as povidone iodine freely flowing within the cap in its mode of use, to bathe the connector in antiseptic. However, this sys-tem requires filling of the system with antisepticat the time of use, and thus involves a time-consuming process with the added disadvantage that the antiseptic can be spi]led.

Brief Summary of the Invention The present invention provides a protective cap for a connector which securely receives and provides an antihacterial effect to the connector. At least a portion of the protective cap interior is lined with an absorbent material which retains an antiseptic.
A connector covered by the protective cap is thus placed in an antibacterial environment made possible by contact of the connector with the antiseptic-retain-ina absorbent material, or from migration of the anti-septic, or both.
The protective cap of this invention is presently contemplated for use on solution container connectors, and particularly connectors communicating with the patient in peritoneal dialysis procedures. ~he liquid antiseptic such as povidone iodine, retained in the absorbent material lining within the cap, provides the antibacterial effect. However, use of the protective cap of this invention is by no means limited to the field of peritoneal dialysis. The protective cap of this invention may also be used for other medical ap-plications or other procedur~s where it is desired to provide an antibacterial connection.
The protective cap of this invention is designed to securely receive a connector. The cap itself has a first, outer chamber which has an external opening deined by a skirt which allows enga~ement with a connector. .~n absorbent material lines the outer chamber and is affixed therein. The absorbent mate-rial retains an antiseptic which may be a li~uid suchas povidone iodine.
A second, inner chamber transversely smaller than the first cha~ber is positioned adjacent and open to the first chamber. The second chamber is desi~ned to - ~ -connect and receive ~he medical connector, the end of an administration set, or other types of tubes or ports.
Internal -threads are defined in the second chamber, and are designed to engage with external threads of a connector, to provide a threaded connection between the connector and cap. A flange on the connector may be received within the skirt of the protective cap to provide a seal, which additionally helps -to reduce the possibility of contamination of the connector.
In manufacturing the cap, che first, outer chamber of a protective cap may be lined with the absorbent material. Ribs formed in th~ first chamber and directed towards the center of the first chamber project lnto the absorbent material and act as energy directing ribs, focusing ultrasonic energy to the absorbent material during an ultrasonic sealing step, whereby the absorbent material may be fi,mly welded to the inner chamber of the protective cap. Thereafter, an anti-septic i5 provided to the absorbent material, which takes it up and retains it.
Various aspects of the nvention are as follows:
A protective cap for a connector which securely receives and provides antlbacterial effect to the con-nector, said cap comprising: a first, outer chamber having an external opening fixedly lined with an absorbent material, said absorbent material retaining an antiseptic; and a second, inner chamber, smaller than said first chamber, adjacent and open to said first chamber, having connecting means for receiving connecting means from said connector.
A protective cap for an externally threaded, flanged medical connector which securely receives and provides antibacterial effect to the medical connector, said cap comprising: a first, outer chamber having an external opening and having a plurality of inwardly directed ribs, an absorbent material lining said inner 3~
-4a-chamber, carried on the inner surfaces o-f said ribs, said absorbent material retaining a li~uld antiseptic, a second, inner chamber, smaller than said first chamber and adjacent and open to said first chamber, having internal threads 5 for threaded cooperation with external threads of a connec-tor' and a skirt defined by said external opening to said first inner chamber for sealingly engaging a flange of a connector received in said cap.
A protective cap for an externally threaded, flanged 10 material connector which securely receives and provides an antibacterial effect to the medical connector, said cap comprising: a first, ~uter chamber having an external opening, a tubular the-moplastic, absorbent sponge, said outer chamber having a plurality o~ inwardly directed ribs 15 serving as energy directors for ultrasonic welding of said tubular absorbent sponge to the inner surfaces of said ribs, said absorbent sponge carrying liquid antiseptic; a second, inner chamber, smaller than.~;aid first chamber and adjacent and open to said first chamber, having internal 20 threads for threaded cooperation with external threads of a connector; a slcirt defined by said external opening to said first inner cham~er for sealingly engaging a flange of a connector received therein; and a removable water vapor barrier lid covering and adhering to an outer face of said 25 skirt.
An antibacterial closure system, said system compri-sing: a protective cap for a connector; said connector comprising a main tubular member having external connecting means; said protective cap comprising; a first, outer 30 chamber having an external opening and fixedly lined with an absorbent material, said absorbent material retaining an antiseptic; and a second, inner chamber, smaller than said first chamber and adjacent to said first chamber, having internal connecting means for rece.iving said 35 external connecting means of said connector.

~3~

-4b-A method o~ providing a thermoplastic protec-tive cap for a connector which provides antibacterial effect to the connector, comprising the steps of:
lining an inner chamber of a protective cap, having 5 an external o~ening, with a thermoplastic absorben-t material; exposing said protective cap to ultrasound energy whereby said absorbent material is welded to said inner chamber of said protective cap; and providing an antiseptic to said absorbent mate.rial.

~3~

Brief Description of the Dr _ln~s For a more complete understanding of this inven-tion, reference should now be had to the embodimen-t illustrated in greater detail in the accompanying draw-ings.
In thc drawings:
Figure 1 is a perspective view of the protective cap of this invention.
Figure 2 is an end elevational view of the protec-tive cap of this invention, showing the absorhent mate-rial lining and a series Or inwardly directed ribs.
Figure 3 is a longitudinal cross sectional view of a connector covere~ by the protective cap of this invention.

3~

Description of the Preferred Embodiments Turning now to the drawings, Figure 1 is a per-spective view of the protective cap 10 of this inven-tion. Gripping fins 12 on the exterior portion of closed end 14 of protective cap 10 provide a convenient gripping surface External opening 16 of cap 10 is defined by skirt 18, which also defines outer chamber 28. ~ removable water vapor barrier such as peelable lid 20 of known design adheres to outer face 22 of skirt 18, and is shown in the partially open position. Absorbent mate-rial 24 lines protective cap 10 and is fixedly attached to the inside of the protective cap.
~en removable water vapor, microbial barrier lid 20 is closed, it completely covers and adheres to outer face 22 of skirt 18. Thus when absorbent material 24 retains a volatile antibacterial agent, such as povidone iodine, loss by evaporation is greatly reduced. ~lterna-tively, protective cap 10 ~ay be placed in a preformed plastic blister which is covered by a removable water vapor barrier lid.
The end ~lew of cap 10, as shown in Figure 2, dis-closes a series of longitudinally positioned, inwardly directed ribs 26, formed as pàrt of skirt 18. As shown ln Figure 3, inwardly directed ribs 26 are located in first, outer chamber 2~ of protective cap 10. Second, inner chamber 30 ad~acent, open to outer chamber 28, is also shown.
Referring again to Figure 2, inwardly directed ribs 26 function as ener~y directors for ultrasonic welding of absorbent material 24 to the inner wall of skirt 18 (Figure 3). The cap wall, including ribs 26, is preferably made of a thermoplastic material that will weld to the thermoplastic of absorbent material ~3~

24 when exposed to ultrasound energ~. Absorbent mate-rial 2 A ].S filled with an antiseptic after welding.
Preferahly, the wall of protective cap 10 is made of Hytrel~5556 polyester manufactured by E. I~ du Pont de NeMours & Co., and absorbent material 24 is made of polyether-based polyurethane, although substantially equivalent materials can also be usecl. A preferred antibacterial agent or antiseptic is povidone iodine.
Connector 32 is shown engaged by protective cap lO in Figure 3. The connector 32 shown is a typical connector used with CAPD tubing sets. Tube 34 is shown extending from connector 32 to communicate, for example, with a Tenckhoff catheter implanted in the peritoneal cavity of a patient.
Skirt 18 of protective cap 10 is shown receiving flange 36 of connector 32. Inner chamber 30 having internal threads 3~, cooperates to threadedly lock with external khreads 42 of connector 32.
The tube of absorbent ma-terial 24 is shown contact~
ing main tubular portion 40 of connector 32. Preferably, absorbent material 24 retains an antiseptic or antibac-terial agent. In this manner, an antibacterial effect is provided to main tubular member 40 of connector 32, as well as threads 42 through migration of the antisep-tic.
Skirt 18 may be proportioned to form a tight, an-nular seal area 46 with flange 36. Annular step or shoulder 48 ~ay also he provided in skirt 18 and posi-tioned to enga~e flanqe 3~ for added sealing, and also to prevent overadvancement of connector 32 into cap lO, which could damage the respective threads 42, 38.
The embodiment illustrated in Figure 3, including protective cap lO and connector 32, also comprises the antibacterial closure system of this invention. The ~D3~

closure system is effective in minimizing cont~lina-tion of a connector before it is used or between uses.
The above has been offered for illustrative pur-poses and is not intended to limit the invention of this application, which is defined in the claims below.
I~HAT IS CLAIMED IS:

Claims (19)

1. A protective cap for a connector which securely receives and provides antibacterial effect to the con-nector, said cap comprising:
a first, outer chamber having an external opening fixedly lined with an absorbent material, said absorbent material retaining an antiseptic; and a second, inner chamber, smaller than said first chamber, adjacent and open to said first chamber, having connecting means for receiving connecting means from said connector.
2. The protective cap of Claim 1 wherein said external opening to said first, outer chamber is defined by a skirt for opposing engagement with the connector.
3. The protective cap of Claims 1 or 2 in which said first chamber has a plurality of inwardly directed ribs which function as energy directors for ultrasonic welding of said absorbant material to said inner chamber.
4. The protective cap of Claims 1 or 2 wherein said internal connecting means of said second inner chamber comprise internal threads for threaded coopera-tion with external threads.
5. The protective cap of Claims 1 or 2 further comprising a plurality of gripping fins on an exterior portion of said protective cap.
6. The protective cap of Claims 1 or 2 wherein said absorbent material is tube shaped.
7. The protective cap of Claim 2 wherein said skirt of said protective cap is proportioned to securely engage a mating flange of a connector received therein.
8. A protective cap for an externally threaded, flanged medical connector which securely receives and provides antibacterial effect to the medical connector, said cap comprising:

a first, outer chamber having an external opening and having a plurality of inwardly directed ribs, an absorbent material lining said inner chamber, carried on the inner surfaces of said ribs, said absorbent material retaining a liquid antiseptic;
a second, inner chamber, smaller than said first chamber and adjacent and open to said first chamber, having internal threads for threaded cooperation with external threads of a connector; and a skirt defined by said external opening to said first inner chamber for sealingly engaging a flange of a connector received in said cap.
9. The protective cap of Claims 1 or 8 wherein said absorbent material is made of polyether-based polyurethane and said antiseptic is povidone iodine.
10. The protective cap of Claims 1 or 8 wherein a removable water vapor barrier lid completely covers said external opening to said first chamber, and adheres to an outer face of said skirt.
11. The protective cap of Claims 1 or 8 wherein said cap wall is made of polyester.
12. A protective cap for an externally threaded, flanged medical connector which securely receives and provides an antibacterial effect to the medical connec-tor, said cap comprising:
a first, outer chamber having an external opening, a tubular thermoplastic, absorbent sponge, said outer chamber having a plurality of inwardly directed ribs serving as energy directors for ultrasonic welding of said tubular absorbent sponge to the inner surfaces of said ribs, said absorbent sponge carrying liquid antiseptic;
a second, inner chamber, smaller than said first chamber and adjacent and open to said first chamber, having internal threads for threaded cooperation with external threads of a connector;
a skirt defined by said external opening to said first inner chamber for sealingly engaging a flange of a connector received therein; and a removable water vapor barrier lid covering and adhering to an outer face of said skirt.
13. The protective cap of Claim 12 wherein said skirt of said protective cap defines an annular shoulder which engages an annular flange on said connector to form an annular seal area.
14. An antibacterial closure system, said system comprising;
a protective cap for a connector;
said connector comprising a main tubular member having external connecting means;
said protective cap comprising;
a first, outer chamber having an external opening and fixedly lined with an absorbent mate-rial, said absorbent material retaining an anti-septic; and a second, inner chamber, smaller than said first chamber and adjacent to said first chamber, having internal connecting means for receiving said external connecting means of said connector.
15. The bacteriocidal closure system of Claim 14 wherein on said protective cap, said external opening to said first inner chamber is defined by a skirt, and a flange on said connector sealingly surrounded by said skirt.
16. The bacteriocidal closure system of Claims 14 or 15 wherein said first chamber has a plurality of inwardly directed ribs serving as energy directors for ultrasonic welding to said absorbent material to said inner chamber.
17. The bacteriocidal closure system of Claims 14 or 15 wherein said external connecting means of said connector comprise external threads, and wherein said internal connecting means of said second inner chamber of said protective cap comprise internal threads for receiving said external threads of said connector.
18. A method of providing a thermoplastic protec-tive cap for a connector which provides antibacterial effect to the connector, comprising the steps of:
lining an inner chamber of a protective cap, hav-ing an external opening, with a thermoplastic absorbent material;
exposing said protective cap to ultrasound energy whereby said absorbent material is welded to said inner chamber of said protective cap; and providing an antiseptic to said absorbent material.
19. The method of Claim 18 wherein inwardly directed ribs in the protective cap direct the ultrasound energy to said absorbent material and cause said absorbent ma-terial to be welded to the inner surfaces of said ribs.
CA000427025A 1982-05-14 1983-04-29 Antibacterial protective cap for connectors Expired CA1193984A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US06/378,315 US4440207A (en) 1982-05-14 1982-05-14 Antibacterial protective cap for connectors
US378,315 1982-05-14

Publications (1)

Publication Number Publication Date
CA1193984A true CA1193984A (en) 1985-09-24

Family

ID=23492626

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000427025A Expired CA1193984A (en) 1982-05-14 1983-04-29 Antibacterial protective cap for connectors

Country Status (8)

Country Link
US (1) US4440207A (en)
EP (1) EP0108785B1 (en)
AU (1) AU563886B2 (en)
CA (1) CA1193984A (en)
DE (1) DE3379381D1 (en)
ES (1) ES272228Y (en)
IT (1) IT1163308B (en)
WO (1) WO1983003975A1 (en)

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US4440207A (en) 1984-04-03
ES272228U (en) 1983-11-16
AU563886B2 (en) 1987-07-23
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IT1163308B (en) 1987-04-08
IT8320953A1 (en) 1984-11-05
EP0108785A4 (en) 1985-12-19
WO1983003975A1 (en) 1983-11-24
ES272228Y (en) 1984-05-16
EP0108785B1 (en) 1989-03-15
EP0108785A1 (en) 1984-05-23
AU1559683A (en) 1983-12-02

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