FLUID AND PARTICLE ABSORBING BODY FOR APERTURES IN INJECTION INSTRUMENTS

Abstract: A method for reducing the risk of particle (bacteria) contamination of parts of the body or body fluids by entraining particles in a fluid injected in the part of the body or body fluid by means of a fluid supplying instrument through a fluid inlet associated therewith is characterized in that after injection of the fluid through the fluid inlet, a fluid- and particle-absorbing, vapour-permeable body is inserted in the inlet so as to be exposed with part of its outer surface to the atmosphere surrounding the instrument, while an instrument, such as a cannula, catheter etc., for introducing fluid in parts of the body or body fluids is characterized in that such a fluid- and particle-(bacteria-) absorbing body (4) is provided in the fluid inlet (2) of the instrument.

Description: The present invention relates to a method for reducing the risk of particle contamination of parts of the body or body fluids by entraining particles in a fluid which is injected in the part of the body or body fluid by means of a fluid supplying instrument through a fluid inlet associated therewith. Many infusion cannulæ have an injection port which is connected to the cannula bore and through which a medical solution can be supplied to a patient, often in admixture with the primary solution which is fed to the cannula bore through the patient distal end thereof. The injection port is often controlled by a valve which is disposed in the area of the mouth of the port opening in the cannula bore and which is opened under the action of the injection pressure of the solution supplied through the port by means of a hypodermic syringe. After the solution has been injected, the syringe is retracted from the port and the valve closes the port. It has been noted that a small residual volume of the solution coming from the syringe most often remains in the port upstream of the valve, which is probably due to surface tension phenomena and insufficent valve opening pressure during the final phase of the injection. Such a residual volume may be the course of particle (bacteria) contamination of the patient when, upon a renewed injection of solution through the injection port, it is flushed into the patient. The object of the invention is to solve this problem, which is achieved by inserting a fluid- and particle-absorbing, vapour-permeable body in the fluid inlet after an injection has been performed therethrough. The effect achieved by the invention is surprising. The reason for this is that the bacteria absorbed in the absorbent body together with the residual fluid will die when the absorbed residual fluid evaporates at the surface of the body which is exposed to the surrounding atmosphere. If the injected fluid is isotonic, a further bactericidal effect is obtained in that salt from the isotonic residual fluid, during the evaporation thereof through the porous body, precipitates in the pores of the body and causes bacteria denaturation. In this context, "particles" primarily relates to bacteria, but it will be evident that other types of particles are also comprised by the inventive scope. The fluid absorbing body may contain a bactericide for destroying any surviving bacteria in the residual volume absorbed. Experiments have however shown that this is not necessary in most cases. The absorbent body is advantageously provided with a gripping and protective member which is located outside the entrance opening of the port when the body is applied in the port. This protective member which may be a plastic sleeve placed with press fit over one end of the body (upper end when in use) serves to preclude any contact with the body when being gripped. This may be to particular advantage if the fluid absorbing body is used as a port cover and is left in the port until the next injection should be performed. This protective member should be provided with an aperture or apertures through which liquid absorbed in the body can evaporate into the surrounding atmosphere. If the port is provided with a conventional cover, it is possible after an injection to remove the body from the port and discard it, the port being closed by the cover. The fluid- and bacteria-absorbing body may consist of any conventional material for liquid and bacteria absorption but should be non-crumbling and, suitably, sterilised. An example of a suitable starting material for the body is hydrophilic or hydrophilated porous plastic, such as polyethylene manufactured by POREX® Technologies, Fairborn, USA, as moulded bodies of optional pore diameter, preferably 10-250 µm for a pore volume of 30-70% of the total volume of the body. Another example is a gelling material, such as starch, gel, for instance JODOSORB® from Perstorp Aktiebolag, Sweden, containing an iodine/dextrin complex which can be enclosed in a cup-shaped stiff sleeve provided with apertures as described above. A further example are cellulosic fiber materials. The absorbent body may also consist of a composite material which is made up of layers of material having different absorbency, and may be provided on its surface exposed to the atmosphere, with a thin membrane permeable to vapour but not to bacteria. Such membranes are available on the market as sterile filters having pores of about 0.1-1.0 µm. Although the invention has been described above in connection with the injection port of a cannula, it will be understood that it is also applicable to other apertures, both inlet and outlet apertures, in medical instruments, such as catheter (luer) connections etc., through which a fluid is supplied to a patient. One embodiment of the invention will now be described in greater detail hereinbelow with reference to the accompanying drawing which is a sectional view, with parts broken away, of a cannula equipped with a fluid- and bacteria-absorbing body. In the Figure, there is shown a conventional cannula 1 having an injection port 2 and an injection port valve 3. In the port 2, there is inserted with a relatively tight fit a plug 4 which consists of porous hydrophilated polyethylene having pores of about 50 µm and which is here integrated in a cap 5, such that the part has its external side surrounded and its top face covered by a flange formed integrally with the plug. A thin sterile filter 6 is mounted on the outer side of the cap. Both the plug 4 and the filter 6 are vapour-permeable, while the filter 6 is bacteria-impermeable. With the tip of the cannula inserted in the patient and with the cap 5 removed from the port 2, a solution is injected in the cannula bore through the port 2. After completion of the injection and withdrawal of the syringe, the cap is again placed on the port 2 for absorbing, by means of the plug 4, the residual volume of solution and any bacteria present therein. Tests have been carried out with a view to studying the capacity of the fluid- and particle-absorbing body according to the invention to absorb residual fluid so as to prevent bacteria growth. The tests were carried out on five cannulæ of the type illustrated in the Figure, using a suspension of the bacterium Staf aureus NCTC 8532 in a concentration of 10³/ml and a POREX® plug as shown in the Figure, however without a sterile filter 6. In the injection ports, 20 µl (about 600 bacteria) of the suspension was injected, whereupon the plugs were inserted in the ports. The cannulæ were then kept at 35°C in heating cabinets overnight. The next morning each injection port was rinsed five times with 100 ml of sterile soybean broth (nutrient solution), whereupon another 20 µl of the suspension was injected in the port and the pertaining plug was again placed in the port. The rinsing liquid was poured in test tubes containing 3 ml of sterile soybean broth and being placed in heating cabinets at 35°C. This procedure was repeated for five days. The growth in said quantity of soybean broth was checked every day by means of conventional turbidity measurements. No growth (turbidity) of said bacteria could be detected in said quantity of soybean broth (rinsing liquid + added sterile soybean broth) at any time. The test described above was repeated with the difference that the amount of bacteria suspension (20 µl) to be tested was injected in the ports every second hour during the five days of testing, instead of once a day. Otherwise, the same procedure as described above was followed. Nor did this test exhibit any growth of bacteria.

Claims: 1. Method for reducing the risk of particle (bacteria) contamination of parts of the body or body fluids by entraining particles in a fluid which is injected in the part of the body or body fluid by means of a fluid supplying instrument through a fluid aperture associated therewith, characterized in that after injection of the fluid through said fluid aperture, a fluid- and particle-absorbing, vapour-permeable body is inserted in said aperture, such that said body with part of its outer surface is exposed to the atmosphere surrounding the instrument. 2. Instrument for introducing a fluid in parts of the body or body fluids, such as a cannula, catheter etc., characterized in that a fluid- and particle-(bacteria-) absorbing, vapour-permeable body (4) is provided in the fluid inlet aperture (2) of the instrument with part of its outer surface exposed to the atmosphere surrounding the instrument. 3. Instrument as claimed in claim 2, characterized in that the body (4) consists of a porous, hydrophilic or hydrophilated material. 4. Instrument as claimed in claim 3, characterized in that the material is plastic. 5. Instrument as claimed in any one of claims 2-4, characterized in that the body (4) has a particle-(bacteria-) impermeable, vapour-permeable membrane (6) on its surface exposed to the surrounding atmosphere. 6. Instrument as claimed in any one of claims 2-4, characterized in that the body has an apertured protective cap on its end containing the surface exposed to the surrounding atmosphere. 7. Instrument as claimed in any one of claims 2-6, characterized in that it is a cannula provided with an injection port which forms said fluid inlet aperture in which said body is inserted. 8. Instrument as claimed in claim 2, characterized in that the body (4) contains a bactericide.

Inventors: LARSSON, NILS EVERT, STENBERG, KAJ OVE
Applicants: VIGGO AB
Application year: 1985
Main classification: A61M25
IPC codes: A61M39, A61M25, A61M5