JPH0499573A - Hollow yarn material exchanger of endodetention type - Google Patents

Abstract

PURPOSE:To allow the easy insertion of an artificial lung into a vein and the uniform loosening of many pieces of hollow yarn after insertion by disposing small-diameter tubes provided with elongating and contracting means in parallel with hollow yarn bundles and fixing the tubes to the convergent fixing parts at both ends of a hollow yarn bundle. CONSTITUTION:A stylet 7 is inserted from the opening end of the 2nd tube 3 inserted from the aperture of the artificial lung L into the 1st tube and the front end is pressed to a 1st header and is further inserted until a stopper 12 comes into contact with the opening end of the 2nd tube 3. The artificial lung L is inserted into the vein while this hollow yarn bundle is held tense. The insertion of the artificial lung L into the vein is easy as the hollow yarn is reduced in diameter and the stylet 7 is elastic. The adhesive fixing parts 8, 8 of the hollow yarn bundle are brought near to each other again by the shrinkage of the 2nd tube 3 when the stylet 7 is removed after the detention of the artificial lung L in the vein is confirmed and, therefore the hollow yarn is deflected and loosened in the vein A and the blood starts flowing between respective pieces of the hollow yarn.

Description

Detailed Description of the Invention (Industrial Application Field) The present invention is an indwelling hollow fiber type mass exchange device, in particular, an indwelling hollow fiber mass exchange device that adds oxygen to blood IN VIV [nW] without involving the patient's lungs. The present invention relates to an artificial lung suitable for removing carbon dioxide from the present invention.The present invention will be described below regarding an artificial lung, but the present invention device can be used to indwell in the body such as an artificial kidney, an artificial pancreas, an ascites filter, etc. Hollow fiber material exchange 11
1 or a removal device.

(Prior art) As a treatment for blood gas exchange insufficiency, the inflow of M cords into the lungs is usually increased by increasing the oxygen concentration of inspired air or by mechanically insufflating the lungs. If you want to avoid artificial respiration, or if your lungs are affected and gas exchange on a ventilator is insufficient, you can either suppress your metabolism or have to perform gas exchange with an artificial lung.8 Artificial Lung For gas exchange, an extracorporeal circulation method is used in which venous blood is led out of the body with a cannula, gas exchanged, and then the blood is returned.
However, this method required large equipment, advanced sweeping techniques, and caused a lot of blood damage and bleeding, making it difficult to increase the survival rate. However, recently, as the gas permeability of hollow fibers has improved, oxygenator lungs have become smaller, and with changes in thinking about the suitability of oxygenators, a method of inserting an oxygenator into a blood vessel and performing gas exchange under its own blood flow has been introduced. Development is receiving attention [Tran
s, Am, Soc.

Artlf, J++t, Org, 33.570
Ba 1987)].

Such an artificial lung consists of a large number of hollow fibers that are bundled and fixed with adhesive so that both ends are open, and a first header connected to a gas outlet tube is attached to one end of the fiber, and a first header connected to a gas inlet tube is attached to the other end. Attach the second header that has been attached, and when introducing the oxygenator into the N-group, twist the oxygenator in advance to make it smaller in diameter. The individual hollow fibers are twisted to separate them, allowing blood to flow as evenly as possible through the threads.

(Problem to be Solved by the Invention) In the above device, in order to twist the hollow fiber bundle, a long flexible stylet made of metal or resin is inserted into the center of the hollow fiber bundle in parallel with the hollow fibers. After fixing the thread bundle to the header on the leading and rear end sides, the oxygenator is twisted around the stylet to reduce the outer diameter of the oxygenator.

However, the above method is complicated! Once the oxygenator has been inserted into the NW, it is difficult to visually confirm the shape of the inserted part, especially the state of untwisting, and there may be cases where the oxygenator is not pushed back in enough, or if it is pushed back too much and ends up leaning in the opposite direction. It is difficult to evenly distribute a large number of hollow fibers within a vein, as uneven local twist may occur. Therefore, an object of the present invention is to provide a hollow fiber type mass exchange device that can be easily inserted into the n-section of an oxygenator and can reliably disintegrate a large number of hollow fibers within the rPI.

(Means for solving !IB) As a result of various studies on the M resolution means of the above-mentioned scheme, the present inventors arranged a small-diameter tube equipped with an extensible means parallel to the hollow fiber bundle, and The present invention was achieved by discovering that by fixing both ends of the artificial lung to the converging and fixing parts, it becomes easier to insert the oxygenator into the vein, and moreover, it is possible to unravel the large number of hollow fibers evenly after insertion. .

That is, in the present invention, both ends of a large number of hollow fibers are bonded with an adhesive.
A first conical header having a cavity inside is attached to the tip of the hollow fiber bundle which is fixed to the bundle and has hollow fibers opened at least at the rear end of the bundle fixing part, and the hollow fiber bundle A second header to which the first tube is connected is attached to the other end, and a second tube equipped with a telescopic means is inserted through an opening provided in the side wall of the first tube, and its tip is connected to the first tube. This is an intracorporeal device type hollow fiber type mass exchange AT characterized in that the cavity of the first header is opened, and the second tube is fixed to the focusing fixing parts at both ends of the hollow fiber bundle.

(Function) When inserting the oxygenator of the present invention into the n-group, a stylet is inserted into the second tube equipped with an expansion and contraction means, the tube is stretched, and the tube is stretched between both adhesively fixed ends of the hollow fiber bundle. By expanding it, the hollow fiber bundle becomes tense and the oxygenator can be made thinner, and the elasticity of the stylet makes it easier to insert it into the blood vessel.

Again n#I! When the stylet is removed after inserting an artificial lung into the lungs, il! ! Due to the contraction of the second tube, both adhesively fixed ends of the hollow fiber bundle are brought closer to each other again, so that the hollow fibers can be evenly separated.

<Example> Next, an example of the hollow fiber type mass exchange device of the present invention will be described with reference to the drawings. FIG. 1 is a sectional view showing the state in which the artificial lung #L is inserted into the vein A. The artificial lung is made by converging both ends of a large number of hollow fibers 2 and fixing the converged portions with adhesive 8.8. There is. In Fig. 1, jIj of the hollow fibers is fixed at the adhesive fixing part 8 of the hollow fiber bundle.
The ends are open.

At the tip of the hollow fiber bundle whose both ends are bundled and fixed, there is a hollow W inside.
At the rear end of the hollow fiber bundle, a first conical head 1 having a diameter of 410 is attached, and a second l\Mazda to which a first tube 9 for gas delivery is connected is attached. ing. Then, a second tube 3 equipped with an extensible means is inserted into the first tube through an opening provided in the side wall of the first tube 9, and the tube is connected to the hollow fiber bundle at both end fixing portions 8,
8 and opens into an empty FIO provided in the first ladder 1. The second tube 3 is fixed with an adhesive or the like at both end fixing parts 8.8 of the hollow fiber bundle. The opening provided in the side wall of the first tube 9 includes the second tube;
A third tube 5 for injecting anticoagulant into the vein or sampling blood as necessary.
is inserted, and its tip is fluid-tightly connected to an opening provided in the second spade 6. The opening provided in the side wall of the first tube 9 is closed with III\i or the like after the second tube 3 and third tube 5 are inserted.

The hollow fibers 2 used in the device of the present invention include those that can be used for artificial organs, such as cellulose, cellulose acetate, polymethyl methacrylate, polyacrylonitrile,
Hollow fibers made of ethylene vinyl alcohol, polyamide, polysulfone, polyvinyl alcohol, polyethylene, polypropylene, poly-4-methylpentene, silicone, etc. can be used. It is preferable to impart elasticity to the hollow fibers by crimping, curling, etc., as this allows the hollow fibers to be more uniformly dispersed within the vein.

First, second and third tubes3. 5. 9 is made from a known medical cable material.

Suitable examples include polyvinyl chloride, polyethylene, polypropylene, polyamide, polyurethane, silicone rubber, and latex rubber.

As the second tube 3 equipped with an elastic means, a material with a high elongation modulus, such as silicone rubber or segmented polyurethane, is preferably used because the tube itself has elasticity, while polyvinyl chloride, When using resins such as polyethylene, polypropylene, and polyamide that do not exhibit stretchability by themselves or have a low elongation modulus, it is necessary to provide the following stretch means, for example.

■Make the length of the second tube and hollow system longer than the 1st length of the internal indweller in advance, and when inserting it into the blood vessel, insert it in a stretched state to allow it to slacken inside the blood vessel.

It is made up of two inner and outer tubes with a 019 alignment mechanism.

■The outside of the two inner and outer tubes with a slitting mechanism is covered with a thin elastic tube.

(2) Shape S A resin or metal having a self-inertia effect is used for at least a part of the second tube, and the shape memory effect is used to reversibly expand and contract the second tube.

The second tube 3 is attached to the first tube 9 from the side wall of the first tube 9.
through the tube and through the electric flux fixing part of the hollow fiber bundle to the internal space f8 of the first heladder 1! It is open to io. ! i second
The tube has urethane on the electric flux fixing part 8.8 of the hollow fiber bundle.
It is fixed using adhesives such as epoxy and adhesives, net melt, and various fillers.

The first and second paddles 1 and 6 are made of resin such as polyvinyl chloride, polyethylene, polypropylene, polyurethane, silicone, or the like. In particular, resins having anti-blood coagulation properties such as polyurethane are suitable. It is preferable that the tip of the first header 1 has a circular shape so that the oxygenator can be inserted smoothly into the blood vessel, and the inside of the first header 1 allows gas introduced from the second tube 3 to be inserted into the blood vessel. Empty W410 is provided to once collect and then distribute evenly to each hollow fiber. The first and second headers 1.6 are fluid-tightly attached to both ends of the hollow fiber bundle using an adhesive such as polyurethane.

In order to insert the artificial lung into the vein A, a stylet 7 as shown in FIG. 2 is required, for example. This stylet is a flexible hard wire-like thing made of metal or resin, and a loop part 11 for holding the stylet 7 is provided at the rear end, and the stylet is held close to the loop part. A stopper 12 is provided for insertion into the tube a predetermined length. Since the stylet is required to have rigidity that allows the hollow fiber bundle and the second tube to be stretched simultaneously, a metal material is usually used rather than a resin material, and a wire-like or wire structure is preferably used rather than a spring structure.

Next, a method of using the device of the present invention will be explained.

First, as shown in FIG. 3, the second tube 3 is inserted into the first tube through an opening provided in the side wall of the first tube 9, which is adhered to the second spade 6 of the artificial 111iL.
From the open end of the stylet, insert the stylet 7 shown in FIG. do.

In this state, the distance between the adhesive fixing parts 8.8 at both ends of the oxygenator widens and becomes longer, so the hollow fiber bundle becomes tighter and the oxygenator becomes thinner. With this hollow fiber bundle under tension, the artificial lung is inserted into the vein. At this time, the artificial lung tube can be easily pushed into the vein due to the m-diameter hollow fiber bundle and the elasticity of the stylet 7.

After confirming that the artificial lung tube has been placed in the vein, the stylet 7 is removed, and as shown in the figure, the adhesive fixing portions 8.8 at both ends of the hollow fiber bundle are compressed by the contraction of the second tube 3. As they approach again, the hollow fiber bends and comes apart within n vein A.
Blood will now flow between each hollow fiber. The loose state of the hollow fibers within the above n group must be confirmed in advance with *acid.

When inserting an oxygenator into a vein, the hollow fiber bundle may be inserted in a taut state as shown in Figure 3, but to make insertion easier, the oxygenator may be placed in a bag. The a16 that houses the oxygenator, which is preferably inserted into a vein in a closed state, has a tube shape with a conical tip as shown in FIG. A separation line 14 consisting of, for example, two rows of perforations or a V-shaped cut extends from the adhesive part 13 that fixes one end of the tape 15 to the end of the separation string (beer-off) extending inside the bag. It is provided. When using this tube-shaped bag 16, after storing the oxygenator in the tube-shaped bag 16 (section 5), the inside of the bag is filled with physiological saline, etc. to expel the air, and the oxygenator is removed. After the oxygenator is inserted into the specified position and the separation tape 15 is pulled, the bag is removed at the separation line 14. is divided. In this shape, the bag can be easily removed by pulling it towards you.

(Example 1) A tube 3 with an inner diameter of 200 mm and an outer diameter of 2 mm is placed around the second tube 3 made of silicone rubber with an inner diameter of 2.0 m, an outer diameter of 4.0-1 and a length of 36 cm.
Arrange 1,000 polypropylene porous hollow fibers of 50μ and length of about 41cm, bundle both ends so that the diameter at the heavy end is 10mm, seal with silicone adhesive, and fix to silicone rubber tube. The artificial lung shown in Fig. 3 was fabricated. The oxygenator is housed in the tubular bag shown in FIG.
The end of the bag was closed as shown in FIG. 5. Afterwards, it was inserted into the Daiseiha through a puncture. When the tubular bag is removed and the stylet is removed, the shrinkage force of the second tube 3 made of silicone rubber causes the hollow fiber bundle to shorten in the longitudinal direction, and the hollow fiber bundle becomes approximately 35 mm in diameter within the tflll. It is placed in a loose shape.

Under this condition, when oxygen gas is flowed into the second tube and negative pressure is applied to the second tube which communicates with the inside of the hollow fiber,
Oxygen gas flows through the second tube to the first header, then flows inside the hollow fiber and exits the outlet of the first tube, oxygenating the blood through the porous hollow fiber wall. come. If a third tube is installed, anticoagulant can be passed through this tube and continuously injected into the blood from the second header to help prevent blood clot formation in the oxygenator. .

(Example 2) Sections 1 and 16 show an example in which the device of the present invention was used for peritoneal dialysis. In this example, the second tube 3 has an inner diameter of 1
．． A polyvinyl chloride tube with a length of 2 m, an outer diameter of 2.5 pieces, and a length of 18 cm, which was previously curled by heat treatment, is used. The hollow fibers 2 are made of crimped synthetic polysulfone bellies (inner diameter 200μ, outer diameter 280μ, water permeability 15i1/min/rrr/mm, Ig, 800 pieces), and the adhesive fixing part at the tip of the hollow fiber bundle is attached. At 8 (J), the hollow part is filled and opened at the adhesive fixing part 8 at the rear end, and the diameter is 12 to 11, and the length when contracted is 16 cm.

After filling the inside of the hollow fiber of this device with physiological saline, the second tube made of polyvinyl chloride is inserted with the stylet.
Stretch it to 8 cm and use the introduction guide to puncture it.
1M17 into the TI cavity.

When the stylet is slowly removed, the hollow fiber bundle contracts as the polyvinyl chloride tube uncurls.
When the first tube 9, which is placed in the am as an indwelling device with a length of 16 cm, is connected to the dialysate bag 18 placed at a position higher than the patient, the dialysate is fed into the hollow fiber due to the head difference. permeates and flows into the peritoneal cavity. After retaining the dialysate in the peritoneal cavity for several hours, when the dialysate bag is placed at a position lower than the patient, pressure is applied inside the hollow fibers.
The dialysate in 1IIrl is drawn into the device through the membrane,
Abdominal dialysis can be effectively performed using the apparatus of the present invention, which is connected to the dialysate bag from the first tube.

In this method, the bore of the hollow fiber exhibiting water permeability is 0.01 μm.
Because of its small size, even if the dialysis side becomes contaminated, bacteria will not flow into the peritoneal cavity, allowing safe treatment.

(Effects of the Invention) As described above, the device of the present invention stretches the hollow fiber bundle in advance, reduces the diameter of the device, and inserts it into the body using the puncture method, and then shortens the length of the hollow fiber bundle. By spreading each hollow fiber uniformly and placing it in the body in this state, the device is prevented from coming out of the body, and the hollow fibers are spread out to increase the effective contact area with body fluids, which increases the effectiveness. This makes it possible to exchange (remove) materials IN VIVO, which is easy and relatively traumatic.

By using the device of the present invention, new IN VIVO body fluid purification methods such as intravenous gas exchange, intravenous dialysis (filtration), and peritoneal dialysis become possible.

[Brief explanation of the drawing]

Fig. 1 is a sectional view showing the device of the present invention placed in the nR, Fig. 2 is a plan view of the stylet, and Fig. 3 is a plan view of the stylet.
The figure is a cross-sectional view of the device before it is placed in a vein, and FIG. 4 is a perspective view of a tubular bag housing the device of the present invention.
FIG. 5 is a perspective view showing the device of the present invention housed in a tubular bag, and FIG. 6 is a partial sectional view showing the device of the present invention placed in the W cavity. A, Venous 1. Oxygenator 1. Header 2. Tube Stylet 1. Tube Hollow fiber 2. Adhesive fixation part cavity Fig. 3

Claims (1)

[Claims] Both ends of a large number of hollow fibers are bundled and fixed with adhesive, and the hollow fibers are opened at least at the rear end of the bunching and fixing part. At the tip of the bundle, there is a conical first tube having a hollow body inside. A second header is attached to the hollow fiber bundle, and the first tube is connected to the other end of the hollow fiber bundle. An internally indwelling type tube, characterized in that a tube is inserted, its tip is opened into the cavity of the first header, and the second tube is fixed to the focusing fixing parts at both ends of the hollow fiber bundle. Hollow fiber type mass exchange device.