Description of the Prior Art
The medical catheters of the prior art include among others an extremely flexible soft catheter attached to a coupler including a generally rigid housing suitable for grasping between the thumb and forefinger. The coupler housing has an exterior rigid tube or bushing for insertion within the lumen of a soft flexible catheter tubing leading to a patient. Flow through the flexible tubing is controlled by a finger operated clamp.
The coupler housing also includes an exterior female luer connector having a central passage which is in communication with the rigid tube and flexible tubing. An outer peripheral lipped area on the female luer connector is designed for interlocking with a male luer connector of a protective cap or with a male luer connector on a syringe or other device. The male luer connector includes a tubular member which is axially disposed within an interiorly threaded member for seating tightly within a female luer connector for communication with the central passage of the coupler. Alternately, the female luer connector is exteriorly threaded.
The female luer connector on the coupler is interlocked with the male luer connector on the syringe or other device by insertion, followed by a twist action. Separation of the female luer connector of the coupler from the male luer connector on the cap or syringe can be achieved by a reverse twist and then pulling apart. The locking assembly which has just been described is generally known in the art as a luer lock assembly.
This design has been extremely well received due to the ease with which a syringe or other male luer connectors containing needed medicines can be secured and later removed.
In recent years, however, it has been found that pathogens have been introduced into the catheter by means of injection, by touch, or perhaps by the spilling of a medicine or a nutritional fluid onto the female luer connector on the coupler. Also, occasionally the needle will damage or perforate the flexible tube during insertion risking the introduction of contaminated air or loss of fluids.
Generally, the female luer connector of the coupler and the male luer connector of the syringe are each provided with a protective cap prior to joining. That is, there is a cap over the female luer member of the coupler. Also, there is a cap over the male luer connector on the syringe. Prior to the joining of the two respective parts, the caps are removed. This reduces but does not eliminate the possibility of introducing pathogens into the body of a patient.
This has led to the addition of an injection cap containing a self-sealing material through which a needle is inserted. The material seals itself after removal of the needle. The injection cap is joined to the female luer connector and can be removed if desired for other direct connection to the female luer connector. It was found, however, that pathogens were still entering the catheter is spite of the provisions to prevent such occurrence. This was especially true with respect to the threaded areas within connecting parts.
In an effort to further minimize the possibility of introducing pathogens into a catheter, applicant has invented a new catheter assembly having several provisions for avoiding the introduction of pathogens and also for avoiding damage to the flexible catheter tubing.
As a consequence, it is an object of the invention to provide a capped catheter assembly having a coupler formed in two major separable pieces, one of which includes a self-sealing septum.
It is a further object of the invention to provide a means for preserving the self-sealing septum and the connection between the major pieces in an aseptic condition.
It is another object of the invention to provide a catheter assembly having a coupler embodying a standard female luer lock fitting with a removable interlocking male luer connection having a self-sealing septum.
It is an object of the invention to provide a catheter assembly having an interlocking two part coupler which permits the removal and replacement of an outer connecting part of the coupler.
It is another object of the invention to provide a catheter assembly having a coupler of two separable interconnecting major parts including a self-sealing septum. An outer protective cap has an antiseptic means disposed within the protective cap so that when the coupler is capped the antiseptic means is in contact with the self-sealing septum and with the interconnection between the major parts of the coupler.
It is a final object of the invention to provide a catheter assembly having a coupler of two separable, interconnecting major parts including an injection cap having a self-sealing septum and an outer protective cap containing antiseptic means which at the same time provides a low profile shape having a smooth exterior surface which will not catch on clothing or cause discomfort to the patient. The unique flattened configuration avoids twisting and facilitates taping.
As used herein and in the appended claims with respect to the catheter assembly, the term "distal" refers to the forward end of the catheter which is inserted into the patient's body. The term "proximal" refers to the trailing, exposed end of the catheter assembly which is external to the patient's body.