Pipe joints or couplings – Frangible element – Score line or groove
Patent
1996-07-22
1998-11-17
Shackelford, Heather
Pipe joints or couplings
Frangible element
Score line or groove
2851311, 604 29, 604905, 604244, F16L 3728, A61M 128
Patent
active
058366199
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a manually-severable coupling device for coupling two tubes. The invention is particularly applicable in medical infusion assemblies such as are used in peritoneal dialysis (PD), and is therefore described below with respect to such an application.
Many of the treatments used today in medical practice involve infusing solutions into the patient and/or draining fluids from the patient. Such treatments includes inserting an invasive device such as a catheter or needle into the patient, carrying out the treatment, and removing the invasive device. In the event that numerous such treatments are necessary, a catheter is used implanted, and the vessel or bag used for the treatment is connected to and disconnected from the implanted catheter. However, the numerous manipulations involved greatly increase the danger of infective agents entering the body at the site of the catheter. Any reduction, therefore, in the number of manipulations at the catheter inlet can be expected to lead to a corresponding lessening of the risk of infection.
One of the treatments commonly used for patients suffering from prolonged renal failure is Continuous Ambulatory Peritoneal Dialysis (CAPD). In CAPD, a sterile dialysis solution is infused into the peritoneal cavity of the patient via an implanted catheter. Following an equilibration period of a few hours, during which waste products of the body diffuse into the solution, the waste-containing solution is drained from the cavity and a fresh solution is introduced.
The above procedure is normally performed by the patient on an ambulatory basis, and involves a number of connections and disconnections which must be performed under strictly aseptic conditions. One of the major problems plaguing peritoneal dialysis (PD) is the infection of the peritoneal cavity (peritonitis) caused by breaches in the aseptic connection procedure. These infections may become severe, and at times may result in removal of the patient from the dialysis program.
Many improvements in CAPD have been introduced over the years to reduce the risk of contracting peritonitis. One of these was the development of the "double bag" system, in which a closed sterile system includes both an empty drainage bag and a full solution bag. This system obviates the use of separate connection tubing for each of the bags, thus reducing the number of connections and disconnections. When using this system, the inlet port of the implanted catheter is exposed to the environment only twice during one treatment cycle: once when a new PD set is connected to the catheter, and once when the set is disconnected.
A further development in this field was recently described in U.S. Pat. No. 5,221,267 to Folden. In that system, a friable tube coupling, manually breakable in a snap manner by a bending force, is positioned adjacent to the end of the PD set which is connected to the catheter. Following infusion of the sterile solution, the patient permanently clamps the tubing section interposed between the catheter and the coupling, and then disconnects the infusion system by bending the coupling until it breaks. This reduces the number of exposures of the catheter by 50%. Before the next fluid exchange, the patient simply disconnects the tubing stump from the previous exchange and connects a new set.
Although the system of Folden decreases the risk of infection, it contains a number of disadvantages. The friable tubing must not be too difficult to break so as to be suitable for patients in a weakened condition. On the other hand, if the tubing can be broken too easily, it may break accidentally before the end of dialysis. This is of course very dangerous, as in such a case sterility is suspended and infection may result. In addition, jagged ends of the coupling can wound the patient, introducing infection in that manner. Finally, the rigidity of the coupling makes it unwieldy in view of the various manipulations necessary during the dialysis treatment.
An object of the present invention is to provide a manually-sev
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Nov. 1965.
Shemesh Eli
Tobe Ellen
Migada Inc.
Shackelford Heather
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