JPS5919704B2 - Artificial organs for heat sterilization - Google Patents

Description

[Detailed description of the invention] This invention relates to artificial organs for heat sterilization.

Sterilization methods for artificial organs such as artificial kidneys include filling these organs with an aqueous solution containing a disinfectant such as formalin;
Methods using sterilizing agents, such as filling with sterilizing gas such as ethylene oxide, are known.

However, in such conventional methods, the disinfectant is harmful to the human body, so it is necessary to clean the inside of the artificial organ before use.

In this case, there are many problems such as residual formaldehyde and the formation of harmful substances such as chlorohydrin when replacing the contents with physiological saline, etc., and the amount of time and effort required to remove disinfectants, etc., and it is not always satisfactory. I can't say it's a method.

Therefore, a method has been proposed in which the artificial organ is filled with physiological saline and sterilized under pressure and heat in an autoclave without using the above-mentioned drugs.

In this case, there is a risk that the artificial organ may be cracked or destroyed due to thermal expansion of the filled physiological saline, and this problem must be solved.

Conventionally, as a solution to this problem, a buffer bag with a cannula is connected to the blood port or dialysate port of the artificial organ, sterilized in an autoclave in that state, and after sterilization, the buffer bag is removed and packaged. A method of sterilizing with oxide gas, or attaching a deformable bag-like plug to the blood port or dialysate port of an artificial organ, and removing this bag-like plug after autoclave sterilization,
Methods have been proposed, such as replacing it with a regular rubber stopper and packaging it in a sterile atmosphere.

However, these methods involve complicated steps from autoclave sterilization to obtaining a sterilized package, requiring many steps, and there is also a risk of recontamination during post-treatment after autoclave sterilization.

In other words, in the former method of using a buffer bag with a cannula, there is a risk of contamination with mold, bacteria, etc. at the point where the cannula is inserted, and in the latter method of using a bag-like stopper, there is a risk of contamination between the bag-like stopper and the normal one. There are problems such as the fact that it is extremely difficult to replace the cap with a cap and to package it in completely sterile conditions.

Furthermore, in these conventional methods, cooling with cooling water after autoclaving is also performed before packaging, so consideration must be given to contamination caused by this.

In addition, in these conventional methods, physiological saline, etc. is defoamed before filling it into the artificial organ, but it is difficult to completely defoamer, and a considerable amount of water is left in the blood port after autoclave sterilization. Gas accumulates.

This accumulated gas causes problems such as interfering with the uniform flow of blood into the hollow fiber.

Therefore, conventionally, in order to remove this accumulated gas, it was necessary to remove the cap during priming before use and perform extremely troublesome operations such as replenishing the liquid with a syringe or the like.

This invention was made in view of the above circumstances, and is suitable for pressurization and heat sterilization using an autoclave, etc., allows for simple and easy removal of air bubbles accumulated after heat sterilization, and furthermore, The purpose is to provide an artificial organ that can be extremely easily connected to circuits, etc.

That is, the present invention provides a device main body that includes a blood processing mechanism, and an expandable hydraulic pressure relief device that is provided so as to communicate with either a blood port or a dialysate port provided in communication with the device main body. A tube body, and a solution harmless to the human body filled and housed in the device main body and the expandable hydraulic pressure relief tube body, and the volumetric expansion of the solution during heat sterilization is caused by the expansion of the hydraulic pressure relief tube body. The present invention provides an artificial organ for heat sterilization, which is characterized in that it can be absorbed by the body.

The present invention will be explained below based on illustrated embodiments.

FIG. 1 shows the case where the present invention is applied to a hollow fiber type artificial kidney device, and schematically shows a device main body 1, a hydraulic pressure relieving tube body 2, and a device filled with liquid so as to fill the inside thereof. It consists of a solution 3 such as physiological saline.

The main body 1 of the apparatus has a substantially cylindrical shape, with blood ports 4 and 5 protruding from both left and right ends, and dialysate ports 6 and 7 protruding in the same direction from the peripheral wall near both left and right ends.

A large number of hollow fibers 8 are housed inside the device main body 1 in a substantially parallel manner along the longitudinal direction of the device main body 1. The internal passages of the hollow fibers 8 are in communication with the blood ports 4 and 5, and the outer gaps are It is in communication with the dialysate boat 6,T.

The solution 3 such as physiological saline to be filled into the device main body 1 and the hydraulic pressure relief tube 2 is one that has been degassed in advance by degassing under reduced pressure or the like.

There are no particular restrictions on the material and structure of the device main body 1 (the same materials as conventional ones can be used).

The hydraulic pressure relief pipe body 2 is made of an expandable material such as silicone, natural rubber, or synthetic rubber, or a structurally expandable material such as a flat shape or a bellows shape, and is suitable for use during heat sterilization using an autoclave or the like. Any material may be used as long as it can sufficiently absorb the volume increase of the filling solution and does not excessively increase the internal pressure within the device (usually 2 Kg/cf/i or less).

Furthermore, the hydraulic pressure relief tube 2 is in communication with blood ports 4 and 5 provided protruding from both ends of the device main body 1, and the solution 3 filled in the device body 1 is freely passed through the hydraulic pressure relief tube 2. It is designed so that it can be circulated.

On the other hand, the dialysate port 6.7 is sealed.

When heat sterilizing this artificial kidney device using an autoclave, etc., first use polypropylene or nylon.

, l-'' The main part or the entire device is airtightly packaged using a packaging material made of a resin with good heat resistance such as IJ carbonate.

In this case, it is preferable to bring the packaging material and the packaged object into close contact as much as possible by vacuum packaging or the like to improve heat conduction during heat sterilization.

The heating temperature, pressure, etc. during heat sterilization are not particularly different from those in the conventional case.

For example, temperature 110° to 120°C, pressure 1.8Kf/-
It is done before and after.

In the artificial kidney device heat-sterilized in this manner, air bubbles accumulate in the blood ports 4 and 5.

However, these bubbles can be removed more easily and easily by using the hydraulic pressure relief tube 2.

That is, when using it, first remove the packaging material, press and seal the vicinity of the center of the tube body 2 (for example, the position A in the figure) with an appropriate lamp means or by hand, and then close the blood port on the artery side (
For example, remove the end of the tube 2 that is fitted into the blood port 5).

Next, by manually squeezing or pressing the two parts of the tube between the sealed point (point A) and the venous blood port (for example, blood port 4), the gas accumulated in the arterial blood port can be removed. is pushed out by the hydraulic pressure within the device main body 1.

After confirming that the accumulated gas has been removed in this way, the arterial blood circuit is connected.

Next, remove the 2nd end of the tube from the other blood port (venous blood port) and connect it to the venous blood circuit.

In this case, the accumulated gas in the blood port on the venous side can be removed by the blood flowing from the artery side to the venous side in the hollow fiber 8 without performing a similar removal operation, and even if some gas remains, the blood will be removed. This is not a problem because it does not substantially interfere with the distribution of

In the above embodiment, both ends of the hydraulic pressure relief tube 2 are connected to the blood ports 4 and 5, but one or both of the hydraulic pressure relief tubes 2 are connected to the dialysate port 6.1. It's okay.

FIG. 2 shows an example in which one side of the hydraulic pressure relief tube body 2 is connected to the dialysate port I and the blood port 4 is tightly plugged.The other mechanisms are exactly the same as the embodiment shown in FIG. , are given the same reference numerals.

In this case, the heat sterilization method is the same as in Figure 1,
The method for removing the gas remaining in the blood port after that is exactly the same as in the case of FIG. The gas accumulated on the blood port 4 side is pushed out by squeezing between this point B and the dialysate port 7, and then connected to the arterial blood circuit, and the other blood port 5
It is only necessary to connect it to the venous blood circuit.

FIG. 3 shows an example in which both of the hydraulic pressure relief pipe bodies 2 are connected to the dialysate ports 6 and 7, respectively, and the blood ports 4 and 5 are sealed, and other mechanisms are shown in the embodiment shown in FIG. 1. It is exactly the same as , and the same reference numerals are given.

After sterilization in the same manner as in the case of Fig. 1, the method for removing the gas accumulated on the artery side is to first remove the cap of the artery side blood port located above, and then open the middle part of the tube body 2. If pressure is applied by hand, the fiber 8 will be slightly crushed by the external pressure caused by this pressure, and the gas accumulated in the upper arterial blood port can be removed.

After removing the gas in this way, the arterial blood circuit can be connected, and the venous blood circuit can be connected to the lower blood port.

In addition, since the examples shown in Figures 1 to 3 above are applied to an artificial kidney device, we have described the case where the operation is performed to remove only the gas accumulated in the blood port on the artery side in advance. However, if necessary, the gas accumulated in the blood port on the venous side can also be removed in advance in a similar manner.

As detailed above, according to the present invention, a relatively long expansible hydraulic pressure relief tube is used to absorb the expansion of liquid during heat sterilization, so the artificial organ is packaged in vacuum packaging or the like. As a result, there is no need to sterilize the packaging again as in the past, and there is no need to remove the buffer bag after heat sterilization, which improves hygiene and manufacturing. This is extremely advantageous in terms of process.

Furthermore, since the fluid pressure relief tubing is connected to two locations, either the blood port or the dialysate port, gas that accumulates in the blood port area after sterilization can be easily removed with a simple operation. Therefore, the defoaming treatment of the solution to be filled into the inside of the device can be completed relatively easily.

In the above description, an example was described in which the present invention was applied to an artificial kidney, but it is clear that the invention is not limited to this, but can also be applied to devices of this type that process blood and other fluids, such as an artificial liver and an artificial lung. Probably.

In addition, the liquid to be filled into the artificial organ device is not limited to the above-mentioned physiological saline, but also a heparin aqueous solution, a glycerin aqueous solution,
Any liquid that does not pose a risk of adversely affecting living organisms, such as distilled water, may be used as appropriate.

[Brief explanation of the drawing]

FIG. 1 is a partially cutaway side view of an artificial kidney device according to one embodiment of the present invention, and FIGS. 2 and 3 are partially cutaway side views of an artificial kidney device according to other embodiments of the present invention. . In the figure, 1... Apparatus body, 2... Hydraulic pressure relief tube, 3... Solution, 4, 5... Blood port, 6, 7 , -0. - dialysate port, 8...
...Hollow fiber.

Claims (1)

[Scope of Claims] 1. A device body containing a built-in blood processing mechanism, and an expandable liquid pressure system installed across the body so as to communicate with either two blood ports or dialysate ports provided in communication with the body. It comprises a relaxation tube, and a solution that is harmless to the human body and is filled and housed in the device main body and the hydraulic pressure relief tube, and the volumetric expansion of the solution during heat sterilization is caused by the expansion of the hydraulic pressure relief tube. An artificial organ for heat sterilization characterized by being absorbable. 2. An artificial organ for heat sterilization according to claim 1, wherein both ends of the expandable hydraulic pressure relief tube are connected to a pair of blood ports protruding from the device main body. 3. The artificial organ for heat sterilization according to claim 1, wherein both ends of the expandable hydraulic pressure relief tube are connected to a pair of dialysate ports protruding from the device body. 4 One end of the expandable hydraulic pressure relief tube body is connected to one of the blood ports protruding from the device body, and the other end is connected to one of the dialysate ports that also protrudes from the device body. The artificial organ for heat sterilization according to claim 1, which is conductive.