JPH0348830B2 - - Google Patents

Description

Claim 1: A protective cap for securely accommodating a medical connector and providing an antibacterial effect thereto, the cap having an outer opening fixedly lined with an absorbent material carrying a disinfectant. a first outer chamber; a second inner chamber adjacent and open to said first chamber, smaller than said first chamber, having connecting means for accommodating said connector connecting means; A protective cap comprising a chamber.

2. The protective cap of claim 1, wherein the outer opening to the first outer chamber is delimited by a skirt for opposing engagement with the connector.

3. The first chamber of claim 1 or 2, wherein the first chamber has a plurality of inwardly directed ribs that act as energy directing devices for ultrasonic welding of the absorbent material to the chamber. protective cap.

4. The connecting means of the connector is an outer thread, and the connecting means of the second inner chamber comprises an inner thread for threaded cooperation with the outer thread. Protective cap for one of the sections.

5. A protective cap according to any one of claims 1 to 4, further comprising a plurality of gripping fins on an outer portion of the protective cap.

6. A protective cap according to any one of claims 1 to 5, wherein the absorbent material is tube-shaped.

7. The protective cap of claim 2, wherein said skirt of said protective cap is proportioned to positively engage a mating flange of a connector housed therein.

8. A protective cap according to any one of claims 1 to 7, wherein the absorbent material is made of polyether-based polyurethane and the disinfectant is povidone-iodine.

9. A protective cap according to any one of claims 1 to 8, wherein a removable water vapor barrier lid completely covers the outer opening to the first chamber and is adhered to the outer surface of the skirt. .

10. A protective cap according to any one of claims 1 to 9, wherein the walls of the cap are made of polyester.

11. The protective cap of claim 7, wherein said skirt of said protective cap includes an annular shoulder that engages an annular flange on said connector to form an annular seal area.

FIELD OF THE INVENTION The present invention relates to protective caps for medical connectors and ports, and to closure systems for the ends of medical tubes or for ports on medical devices. The invention particularly relates to protective caps for medical connectors or medical port openings that provide anti-bacterial effects. The improvement of the present invention consists in providing reliable anti-bacterial effects to connectors or port openings.

BACKGROUND OF THE INVENTION Typical medical connectors in widespread use are connectors for solution containers, administration sets, and catheters. Medical procedures require connections where the bioload (ie, bacterial load) is minimized. Caps containing antibacterial agents can reduce bioload by providing a bactericidal or bacteriostatic effect on the connector site prior to use. Protective caps with antibacterial effects are particularly desirable for components used in peritoneal dialysis, or CAPD.

Currently, thousands of patients with limited or non-existent renal function due to end-stage renal disease are surviving on CAPD and other forms of peritoneal dialysis.

In CAPD procedures, the connection between the dialysate container and the administration set that communicates with the peritoneal catheter is
It usually has to be formed and broken several times a day. The sterility of the flow paths between the various solution containers and the abdominal cavity can be compromised, especially when the patient is performing his own CAPD exchange. Accidental contamination of open connectors by airborne bacteria or patients can contaminate the flow path. The result of such contamination can be peritonitis.

It would be desirable to provide a protective cap for medical connectors, particularly continuous ambulatory peritoneal dialysis connectors, that securely houses the connector and provides anti-bacterial benefits to the connector. For example, Quinton caps manufactured by Quinton Instrument Co. are sold
It contains a liquid disinfectant, such as povidone-iodine, which flows freely within the cap in its mode of use to immerse the connector in the disinfectant. However, this system requires filling the system with disinfectant at the time of use, thus involving a time-consuming operation, and has the additional disadvantage that disinfectant may be spilled.

SUMMARY OF THE INVENTION The present invention provides a protective cap for a connector that securely houses the connector and provides anti-bacterial benefits to the connector. At least a portion of the interior of the protective cap is lined with an absorbent material containing a disinfectant. The connector covered by the protective cap is thus placed in an anti-bacterial environment made possible either by contact of the connector with the disinfectant-bearing absorbent material, or by migration of the disinfectant, or both.

The protective cap of the present invention is currently contemplated for use on solution container connectors, and particularly connectors that communicate with patients during peritoneal dialysis operations. A liquid disinfectant such as povidone-iodine retained in the absorbent lining within the cap provides anti-bacterial effect. However, the application of the protective cap of the invention is in no way limited to the field of peritoneal dialysis. The protective cap of the present invention can also be used in other medical applications or other operations where an antibacterial connection is desired.

The protective cap of the present invention is designed to securely accommodate the connector. The cap itself has a first outer chamber having an outer opening defined by a skirt that allows engagement with the connector. An absorbent material lines the outer chamber and is secured therein. The absorbent material carries a disinfectant, which may be a liquid, such as povidone-iodine.

a second inner chamber that is laterally smaller than the first chamber is adjacent to the first chamber;
and open to it. The second chamber is designed to connect and accommodate medical connectors, the ends of administration sets, or other types of tubes and ports. Internal threads are provided in the second chamber and are designed to engage the external threads of the connector to provide a threaded connection between the connector and the cap. The flange of the connector can be housed within the skirt of the protective cap to form a seal, which additionally helps reduce the possibility of contamination of the connector.

In manufacturing the cap, the outer chamber of the protective cap can be lined with an absorbent material.

A rib formed within the first chamber and directed toward the center of the first chamber projects into the absorbent material and acts as an energy directing rib to focus ultrasonic energy into the absorbent material during the ultrasonic sealing process; The absorbent material can thereby be firmly welded to the inner chamber of the protective cap. The disinfectant is then delivered to the absorbent material which absorbs and retains it.

[Brief explanation of drawings]

For a fuller understanding of the invention, reference should be made to the embodiments illustrated in more detail in the accompanying drawings.

In the drawings: FIG. 1 is a perspective view of the protective cap of the present invention.

FIG. 2 is an end view of the protective cap of the present invention showing the lining of absorbent material and the series of inwardly facing ribs.

FIG. 3 is a longitudinal cross-sectional view of a connector covered by a protective cap of the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Turning to the drawings, FIG. 1 is a perspective view of a protective cap 10 of the present invention. Gripping fins 12 on the outer portion of closed end 14 of protective cap 10 provide a convenient gripping surface.

The outer opening 16 of the cap 10 is bounded by a skirt 18 which also defines an outer chamber 28. A removable water vapor barrier, such as a peelable lid 20 of known construction, is adhered to the outer surface 22 of the skirt 18 and is shown in a partially open position. Absorbent material 24 lines the protective cap 10 and is secured to the inside of the cleaning cap.

When the removable water vapor and microbial barrier lid 20 is closed, it completely covers the outer surface 22 of the skirt 18 and is bonded. Alternatively, the protective cap 10 can be housed in a prefabricated plastic blister covered by a removable water vapor barrier lid.

The end view of cap 10 illustrated in FIG. 2 discloses a series of vertically positioned, inwardly facing ribs 26 formed as part of skirt 18. Ribs 26 facing inward as shown in FIG.
is the first outer chamber 2 of the protective cap 10
Located in 8th. a second inner chamber 30 adjacent to and open to said outer chamber 28;
Illustrated.

Referring again to Figure 2, the inward facing ribs 2
6 serves as an energy directing tool for ultrasonic welding of absorbent material 24 to the inner wall of skirt 18 (FIG. 3). The cap wall including the rib 26 is
Preferably, it is made of a thermoplastic material that welds to the thermoplastic of the absorbent material 24 when exposed to ultrasonic energy. The absorbent material is filled with disinfectant after welding. Preferably, the protective cap 1
0 walls are made of Hytrel 5556 manufactured by EI du Pont Nemours & Co., and the absorbent material 24 is made of polyether-type polyurethane, although substantially equivalent materials can also be used. A preferred disinfectant is povidone-iodine.

In Figure 3, connector 32 is connected to protective cap 10.
is shown engaged by. The illustrated connector is a typical connector used with CAPD tube segments. tube 34
is shown extending from connector 32 in communication with, for example, a Tenckhoff catheter implanted in the patient's peritoneal cavity.

Skirt 18 of protective cap 10 is shown housing flange 36 of connector 32. The inner chamber 30 with inner threads 38 connects the outer threads 4 of the connector 32.
2 and cooperate to lock the screw.

The tube of absorbent material 24 is shown in contact with the main tubular portion 40 of the connector 32. Preferably, absorbent material 24 carries a disinfectant or antibacterial agent. In this manner, an antibacterial effect is provided to the threads 42 by the main tubular portion 40 of the connector 32 and the transfer of disinfectant.

Skirt 18 can be matched with flange 36 to form a tight annular seal area 46. Circular step or shoulder 4 on skirt 18
6 and positioned to engage the flange 36 for additional sealing and to prevent excessive advancement of the connector 32 into the cap 10 which could damage the respective threads 42, 38. can do.

The embodiment illustrated in FIG. 3, including protective cap 10 and connector 32, also includes the anti-bacterial closure system of the present invention. This closure system is effective in minimizing contamination of the connector before or between uses.

The above is provided for illustrative purposes and is not intended to limit the scope of the invention as defined in the claims.