United States Patent c191
`Genatempo et al.
`
`[11]
`
`[45]
`
`4,440,207
`Apr. 3, 1984
`
`[75]
`
`[54] ANTIBACTERIAL PROTECTIVE CAP FOR
`CONNECTORS
`Inventors: Vince Genatempo, Lake Geneva,
`Wis.; Frank Karrasch, Wadsworth,
`Ill.
`[73] Assignee: Baxter Travenol Laboratories, Inc.,
`Deerfield, Ill.
`[21] Appl. No.: 378,315
`May 14, 1982
`[22] Filed:
`Int. Cl.3 ............................................... A61M 5/14
`[51]
`[52] U.S. CI . .................................. 150/52 R; 206/206;
`206/207; 604/256; 604/905
`[58] Field of Search .................................... 604/27-29,
`604/265, 280, 283, 93, 256, 905, 187, 192, 198,
`263; 215/228, DIG. 3; 150/52 R; 206/206, 207
`References Cited
`U.S. PATENT DOCUMENTS
`3,396,727 8/1968 Mount ............................. 604/265 X
`4,232,677 11/1980 Leibinsohn ..................... 604/265 X
`4,273,247 6/1981 Earls ................................... 215/228
`4,306,976 12/1981 Bazzato ............................. 604/28 X
`4,340,052 7/1982 Dennehey ....................... 604/905 X
`4,354,490 10/1982 Rogers ............................ 604/905 X
`
`[56]
`
`4,403,992 9/1983 Bertellini et al ...................... 604/29
`
`OTHER PUBLICATIONS
`Dialysis & Transplantation 10 (May 1981): 421, Quinton
`Instrument Co., advertisement for their product BET A
`CAP II™.
`"The BET A CAP TM System" advertising brochure,
`Quinton Instrument Co. (undated).
`Primary Examiner-C. Fred Rosenbaum
`Assistant Examiner-Michelle N. Lester
`Attorney, Agent, or Firm-Paul C. Flattery; Garrettson
`Ellis; Thomas A. Kmiotek
`ABSTRACT
`[57]
`An article of manufacture and a method are provided
`where a protective cap for a connector provides anti(cid:173)
`bacterial effect to the connector by fixedly lining a
`chamber of the protective cap with an absorbent mate(cid:173)
`rial retaining an antiseptic. By mating a skirt on the
`protective cap with a corresponding flange on a medi(cid:173)
`cal connector, a contamination proof seal is also pro(cid:173)
`vided which functions to limit contamination from the
`outside of the cap and retain a liquid antiseptic on the
`inside of the cap.
`
`15 Claims, 3 Drawing Figures
`
`BAXTER EXHIBIT 1006
`Page 1 of 5
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`

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`U.S. Patent
`
`Apr. 3, 1984
`
`4,440,207
`
`FIG. I
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`/8
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`/6
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`, _ -30
`
`FIG. 3
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`26
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`BAXTER EXHIBIT 1006
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`1
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`4,440,207
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`ANTIBACTERIAL PROTECTIVE CAP FOR
`CONNECTORS
`
`FIELD OF THE INVENTION
`This invention relates to protective caps for medical
`connectors or ports and to closure systems for the ends
`of medical tubing or for ports on medical apparatus.
`The invention particularly relates to a protective 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 antibacte(cid:173)
`rial effect to a connector or port opening.
`
`2
`rial lining within the cap, provides the antibacterial
`effect. However, use of the protective cap of this inven(cid:173)
`tion is by no means limited to the field of peritoneal
`dialysis. The protective cap of this invention may also
`5 be used for other medical applications or other proce(cid:173)
`dures 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,
`10 outer chamber which has an external opening defined
`by a skirt which allows engagement with a connector.
`An absorbent material lines the outer chamber and is
`affixed therein. The absorbent material retains an anti-
`15 septic which may be a liquid such as povidone iodine.
`A second, inner chamber transversely smaller than
`the first chamber is positioned adjacent and open to the
`first chamber. The second chamber is designed to con(cid:173)
`nect and receive the 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 con(cid:173)
`nector, 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 pro(cid:173)
`vide a seal, which additionally helps to reduce the possi-
`bility of contamination of the connector.
`In manufacturing the cap, the first, outer chamber 0f
`a protective cap may be lined with the absorbent mate(cid:173)
`rial. Ribs formed in the first chamber and directed
`towards the center of the first chamber project into the
`absorbent material and · act as energy directing ribs,
`focusing ultrasonic energy to the absorbent material
`during an ultrasonic sealing step, whereby the absor(cid:173)
`bent material may be firmly welded to the inner cham(cid:173)
`ber of the protective cap. Thereafter, an antiseptic is
`provided to the absorbent material, which takes it up
`and retains it.
`
`25
`
`BACKGROUND OF THE INVENTION
`Typical medical connectors in wide use are connec(cid:173)
`tors for solution containers, administration sets and
`catheters. Medical procedures require a connection
`where the bioburden (i.e. bacterial population) is mini(cid:173)
`mized. Protective caps containing an antibacterial agent 20
`can reduce the bioburden by providing a bacteriocidal ·
`or bacteriostatic effect to connector sites prior to use. A
`protective cap having an antibacterial effect is particu(cid:173)
`larly desirable for components used in peritoneal dialy-
`sis, 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 CAPO, and other
`forms of peritoneal dialysis.
`In the CAPD procedure, connections between dialy- 30
`sis solution containers and administration sets which
`communicate with the peritoneal catheter must be made
`and broken, normally several times a day. Particularly
`when the patient is doing his own CAPD exchanges,
`there is the possibility that the sterility of the flow path 35
`between the various solution containers and the perito(cid:173)
`neal cavity may be compromised. 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 particular,
`which securely receive and provide an antibacterial
`effect to the connector. For example, the Quinton Cap
`manufactured by Quinton Instrument Co., is sold, 45
`which contains liquid antiseptic such as povidone iodine
`freely flowing within the cap in its mode ofuse, to bathe
`the connector in antiseptic. However, this sytem re(cid:173)
`quires filling of the system with antiseptic at the time of
`use, and thus involves a time-consuming process with 50
`the added disadvantage that the antiseptic can be
`spilled.
`
`40
`
`BRIEF SUMMARY OF THE INVENTION
`The present invention provides a protective cap for a 55
`connector which securely receives and provides an
`antibacterial 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 cov(cid:173)
`ered by the protective cap is thus placed in an antibacte- 60
`rial environment made possible by contact of the con(cid:173)
`nector with the antiseptic-retaining absorbent material,
`or from migration of the antiseptic, or both.
`The protective cap of this invention is presently con(cid:173)
`templated for use on solution container connectors, and 65
`particularly connectors communicating with the patient
`in peritoneal dialysis procedures. The liquid antiseptic
`such as povidone iodine, retained in the absorbent mate-
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`For a more complete understanding of this invention,
`reference should now be had to the embodiment illus(cid:173)
`trated in greater detail in the accompanying drawings.
`In the drawings:
`FIG. 1 is a perspective view of the protective cap of
`this invention.
`FIG. 2 is an end elevational view of the protective
`cap of this invention, showing the absorbent material
`lining and a series of inwardly directed ribs.
`FIG. 3 is a longitudinal cross sectional view of a
`connector covered by the protective cap of this inven(cid:173)
`tion.
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`Turning now to the drawings, FIG. 1 is a perspective
`view of the protective cap 10 of this invention. Grip(cid:173)
`ping fins 12 on the exterior portion of closed end 14 of
`protective cap 10 provide a convenient gripping sur(cid:173)
`face.
`External opening 16 of cap 10 is defined by skirt 18,
`which also defines outer chamber 28. A 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 material 24
`lines protective cap 10 and is fixedly attached to the
`inside of the protective cap.
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`4,440,207
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`3
`When 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. Alterna- 5
`tively, protective cap 10 may be placed in a preformed
`plastic blister which is covered by a removable water
`vapor barrier lid.
`The end view of cap 10, as shown in FIG. 2, discloses
`a series of longitudinally positioned, inwardly directed 10
`ribs 26, formed as part of skirt 18. As shown in FIG. 3,
`inwardly directed ribs 26 are located in first, outer
`chamber 28 of protective cap 10. Second, inner cham(cid:173)
`ber 30 adjacent, open to outer chamber 28, is also
`shown.
`Referring again to FIG. 2, inwardly directed ribs 26
`function as energy directors for ultrasonic welding of
`absorbent material 24 to the inner wall of skirt 18 (FIG.
`3). The cap wall, including ribs 26, is preferably made of
`a thermoplastic material that will weld to the thermo- 20
`plastic of absorbent material 24 when exposed to ultra(cid:173)
`sound energy. Absorbent material 24 is filled with an
`antiseptic after welding. Preferably, the wall of protec(cid:173)
`tive cap 10 is made ofHytrel@5556 polyester manufac(cid:173)
`tured by E. I. du Pont de Nemours & Co., and absorbent 25
`material 24 is made of polyether-based polyurethane,
`although substantially equivalent materials can also be
`used. A preferred antibacterial agent or antiseptic is
`povidone iodine.
`Connector 32 is shown engaged by protective cap 10 30
`in FIG. 3. The connector 32 shown is a typical connec(cid:173)
`tor used with CAPD tubing sets. Tube 34 is shown
`extending from connector 32 to communicate, for ex(cid:173)
`ample, with a Tenckhoff catheter implanted in the peri(cid:173)
`toneal cavity of a patient.
`Skirt 18 of protective cap 10 is shown receiving
`flange 36 of connector 32. Inner chamber 30 having
`internal threads 38, cooperates to threadedly lock with
`external threads 42 of connector 32.
`The tube of absorbent material 24 is shown contact- 40
`ing main tubular portion 40 of connector 32. Preferably,
`absorbent material 24 retains an antiseptic or antibacte(cid:173)
`rial agent. In this manner, an antibacterial effect is pro(cid:173)
`vided to main tubular member 40 of connector 32, as
`well as threads 42 through migration of the antiseptic. 45
`Skirt 18 may be proportioned to form a tight, annular
`seal area 46 with flange 36. Annular step or shoulder 48
`may also be provided in skirt 18 and positioned to en(cid:173)
`gage flange 36 for added sealing, and also to prevent
`overadvancement of connector 32 into cap 10, which 50
`could damage the respective threads 42, 38.
`The embodiment illustrated in FIG. 3, including pro(cid:173)
`tective cap 10 and connector 32, also comprises the
`antibacterial closure system of this invention. The clo(cid:173)
`sure system is effective in minimizing contamination of 55
`a connector before it is used or between uses.
`The above has been offered for illustrative purposes
`and is not intended to limit the invention of this applica(cid:173)
`tion, which is defined in the claims below.
`What is claimed is:
`1. A protective cap for a connector which securely
`receives and provides antibacterial effect to the connec(cid:173)
`tor, said cap comprising:
`a first outer chamber having an external opening
`fixedly lined with absorbent material, said absor- 65
`bent material retaining ar: antiseptic, said first outer
`chamber being defined by a skirt proportioned for
`sealing engagement with the connector; and
`
`4
`a second, inner chamber having a closed inner end,
`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 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.
`3. The protective cap of claim 1 wherein said internal
`connecting means of said second inner chamber com(cid:173)
`prise internal threads for threaded cooperation with
`external threads.
`4. The protective cap of claim 1 further comprising a
`plurality of gripping fins on an exterior portion of said
`15 protective cap.
`5. The protective cap of claim 1 wherein said absor(cid:173)
`bent material is tube shaped.
`6. The protective cap of claim 1 wherein said skirt of
`said protective cap is proportioned to securely engage a
`mating flange of a connector received therein.
`7. 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, car(cid:173)
`ried on the inner surfaces of said ribs, said absor-
`bent material retaining a liquid antiseptic;
`a second, inner chamber, smaller than said first cham(cid:173)
`ber 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.
`8. The protective cap of claim 7 wherein said absor(cid:173)
`bent material is made of polyether-based polyurethane
`and said antiseptic is povidone iodine.
`9. The protective cap of claim 7 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.
`10. The protective cap of claim 7 wherein said cap
`wall is made of polyester.
`11. A protective cap for an externally threaded,
`flanged medical connector which securely receives and
`provides an antibacterial effect to the medical connec(cid:173)
`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 cham(cid:173)
`ber 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.
`12. The protective cap of claim 11 wherein said skirt
`of said protective cap defines an annular shoulder
`
`35
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`60
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`4,440,207
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`5
`which engages an annular flange on said connector to
`form an annular seal area.
`13. An antibacterial closure system, said system com(cid:173)
`prising:
`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 material, said absor- 10
`bent material retaining an antiseptic; and
`a second, inner chamber having a closed end, smaller
`than said first chamber and adjacent to s,aid first
`chamber and communicating therewith for receiv(cid:173)
`ing said external connecting means of said connec- 15
`
`6
`tor, the external opening of the first inner chamber
`being defined by a skirt, said connector defining a
`flange which is sealingly surrounded by said skirt.
`14. The antibacterical closure system of claim 13
`5 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 cham(cid:173)
`ber.
`15. The antibacterical closure system of claim 13
`wherein said external connecting means of said connec(cid:173)
`tor 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.
`* * * * *
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`20
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`25
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`30
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