JP2512616B2 - Indwelling hollow fiber type substance exchange device - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Industrial Application) The present invention relates to a hollow fiber type substance exchange device of indwelling in a body, in particular, oxygen is added to venous blood by IN VIVO without involving the lungs of a patient. The present invention relates to an oxygenator suitable for removing carbon dioxide. Although the present invention will be described below with reference to an artificial lung, the present invention can also be applied to a hollow fiber type substance exchange or removal device that can be placed in the body such as an artificial kidney, an artificial pancreas, an ascites filter.

(Prior Art) As a treatment for blood gas exchange insufficiency, it is usually performed to increase oxygen concentration in inspiration or functionally ventilate the lung to increase oxygen inflow into the lung. If you want to avoid breathing, or your lungs are affected and gas exchange in the ventilator is inadequate, you must either suppress metabolism, or you must perform gas exchange in the oxygenator. For the gas exchange by the artificial lung, an extracorporeal circulation system is used in which venous blood is drawn out of the body by a cannula, the gas is exchanged, and the blood is returned.
However, this method requires a large device, requires a high level of operation technology, and causes a lot of blood damage and bleeding, which makes it difficult to increase the lifesaving rate. However, recently, with the improvement of the gas permeability of the hollow fiber, the size of the artificial lung is progressing, and due to the change in thinking about the adaptation of the artificial lung, the method of inserting the artificial lung into the blood vessel and exchanging gas under self-blood flow has been proposed. Developed and receiving attention [Trans.Am.S
oc.Artif.Int.Org., 33,570, (1987)].

Such an artificial lung is focused and fixed with an adhesive so that both ends of a large number of hollow fibers are opened, and a first header connected to a gas outlet tube is attached to one end of the hollow fiber and connected to a gas inlet tube at the other end. When the artificial lung is introduced into the vein, it is twisted in advance to introduce the artificial lung in a thin state, and then the artificial lung is twisted in the blood vessel in the opposite direction. The hollow fibers are separated so that blood flows between them as evenly as possible.

(Problems to be Solved by the Invention) In the above device, in order to twist the hollow fiber bundle, a flexible long stylet made of metal or resin is inserted in parallel with the hollow fiber in the center of the hollow fiber bundle, After the thread bundle is fixed to the front and rear end headers, the stylet is used as a shaft to twist the artificial lung to reduce the outer diameter of the artificial lung.

However, the above method is complicated, and once the artificial lung is inserted into the vein, it is difficult to visually confirm the shape of the insertion part, especially the returning condition, and the returning method is insufficient or too much returning. Therefore, it is difficult to evenly disperse a large number of hollow fibers evenly in the vein because partial unevenness such as reverse twisting may occur. Therefore, it is an object of the present invention to provide a hollow fiber type substance exchange device which can be easily inserted into a vein of an artificial lung and which can surely disperse a large number of hollow fibers in the vein.

(Means for Solving the Problems) As a result of various studies on the means for solving the above problems, the present inventors have arranged a small-diameter tube equipped with an expansion / contraction means in parallel with the hollow fiber bundle, and have both ends of the hollow fiber bundle. The present invention has been completed by finding that the fixation to the focusing and fixing part facilitates insertion of the artificial lung into the vein and allows the large number of hollow fibers to be evenly dispersed after the insertion.

That is, according to the present invention, both ends of a large number of hollow fibers are bundled and fixed with an adhesive, and a hollow fiber is internally provided at the tip of the hollow fiber bundle in which the hollow fibers are opened at least at the rear end of the bundled fixing portion. A first header having a conical shape is attached, and a second header to which the first tube is connected is attached to the other end of the hollow fiber bundle, and the first tube side wall is expanded and contracted. Inserting a second tube with means
The hollow fiber type substance exchange indwelling in the body, characterized in that the tip of the tube is opened in the cavity of the first header, and the second tube is fixed to the focusing and fixing portions at both ends of the hollow fiber bundle. It is a device.

(Operation) When the artificial lung of the present invention is inserted into a vein, a stylet is inserted into a second tube equipped with an expansion / contraction means to extend the tube, and the hollow fiber bundle is bonded between both adhesive fixed ends. When expanded, the bundle of hollow fibers becomes tight and the artificial lung can be made thin, and the elasticity of the stylet facilitates insertion into the blood vessel.

When the stylet is removed after inserting the artificial lung into the vein, the second tube contracts again to bring the two adhesive fixed ends of the hollow fiber bundle closer to each other, so that the hollow fibers can be evenly separated. .

(Example) Next, an example of the hollow fiber type substance exchange device of the present invention will be described with reference to the drawings. FIG. 1 is a cross-sectional view showing a state in which an artificial lung L is inserted into a vein A. The artificial lung has a large number of hollow fibers 2
Both ends of the bundle are converged, and the converging portion is fixed with an adhesive. In FIG. 1, both ends of the hollow fiber are open at the adhesive fixing portion 8 of the hollow fiber bundle. At the tip of the hollow fiber bundle whose both ends are focused and fixed,
A conical first header 1 having a cavity 10 inside is mounted. A second header 6 to which a first tube 9 is connected is attached to the rear end of the hollow fiber bundle. Then, the second tube 3 provided with an expansion / contraction means is inserted into the first tube through an opening provided in the side wall of the first tube 9, and the tube is fixed at both ends fixing portions 8 of the hollow fiber bundle. The tip of the cavity 10 that is inserted and provided in the first header 1 is open. The second tube 3 is fixed by an adhesive or the like at both end fixing portions 8 of the hollow fiber bundle. In the opening provided in the side wall of the first tube 9, the second tube and a third tube for injecting an anticoagulant or the like into a vein if necessary, or for sampling blood 5 is inserted, and its tip is liquid-tightly connected to the opening provided in the second header 6. The opening provided in the side wall of the first tube 9 is closed with a resin or the like after inserting the second tube 3 and the third tube 5.

The hollow fiber 2 used in the device of the present invention can be used for artificial organs, for example, cellulose, cellulose acetate, polymethylmethacrylate, polyacrylonitrile, ethylene vinyl alcohol, polyamide, polysulfone, polyvinyl alcohol, polyethylene, polypropylene, poly-4. Hollow fibers made of methylpentene, silicone, etc. can be used. Crimp on the hollow fiber,
It is preferable to give elasticity to the hollow fiber by subjecting it to curling, because the hollow fiber can be more uniformly dispersed in the vein.

The first, second, and third tubes 3, 5, and 9 are made of known medical materials. Preferred are polyvinyl chloride, polyethylene, polypropylene, polyamide, polyurethane, silicone rubber, latex rubber and the like.

As the second tube 3 having an expansion / contraction means, a material having a high elongation elastic modulus such as silicone rubber or segmented polyurethane is preferably used because the tube itself has elasticity, while polyvinyl chloride, When using a resin that does not exhibit elasticity by itself or has a low elongation modulus, such as polyethylene, polypropylene, or polyamide,
For example, it is necessary to provide the following expansion / contraction means.

The length of the second tube and the length of the hollow fiber are set to be longer than the length at the time of indwelling intravenously, and when inserted into the blood vessel, they are inserted in a stretched state and slackened in the blood vessel.

It is made up of two tubes, one with inner and the other with a mechanism for picking.

Cover the outside of the two inner and outer tubes that have a sleeving mechanism with an elastic thin-walled tube.

A resin or metal having a shape memory 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 end of the second tube 3 is opened from the side wall of the first tube 9 into the internal cavity 10 of the first header 1 through the inside of the first tube and the focusing and fixing portion of the hollow fiber bundle. The second tube is fixed to the bundle fixing portions 8 of the hollow fiber bundle with an adhesive such as urethane, epoxy, or silicon, or hot melt or various fillers.

As a material for the first and second headers 1 and 6, resins such as polyvinyl chloride, polyethylene, polypropylene, polyurethane and silicone are used. Resins having anticoagulant properties such as polyurethane are particularly preferable. First
The tip of the header 1 is preferably conical so that the artificial lung can be smoothly inserted into the blood vessel. In addition, the inside of the first header 1 is a cavity for temporarily collecting the gas introduced from the second tube 3 and then uniformly distributing it to each hollow fiber.
Ten are provided. The first and second headers 1 and 6
Is liquid-tightly attached to both ends of the hollow fiber bundle with an adhesive such as polyurethane.

In order to insert the artificial lung L into the vein A, for example, a stylet 7 as shown in FIG. 2 is required. Such a stylet is a flexible hard wire made of metal or resin, and a loop portion 11 for holding the stylet 7 is provided at the rear end, and the stylet is provided in the vicinity of the loop portion. A stopper 12 for inserting the tube into the tube for a predetermined length is provided. Since the stylet is required to have the rigidity that allows the hollow fiber bundle and the second tube to be extended at the same time, a metal type is usually used rather than a resin type, and a wire or wire type is used rather than a spring type. Is preferably used.

Next, a method of using the device of the present invention will be described. First, as shown in FIG. 3, from the opening provided in the side wall of the first tube 9 adhered to the second header 6 of the artificial lung L to the first
The stylet 7 shown in FIG. 2 is inserted from the open end of the second tube 3 inserted into the tube of FIG. 2 to bring the tip into contact with the first header, and further the stopper 12 provided on the stylet. Is inserted until it contacts the open end of the second tube 3. In this state, both ends of the artificial lung are fixed and fixed at the two ends 8.
As the distance between them increases and becomes longer, the bundle of hollow fibers becomes tense and the artificial lung becomes thinner. The artificial lung L is inserted into the vein while the hollow fiber bundle is being tensioned. At this time, the hollow fiber bundle is thinned and the elasticity of the stylet 7 causes the artificial lung L
Is easy to insert into a vein. After confirming that the artificial lung L has been left in the vein, the stylet 7 is removed, and as shown in FIG. 1, the hollow tube bundle is contracted by the second tube 3 to fix both ends of the hollow fiber bundle. As 8 approaches again, the hollow fibers are bent and separated in the vein A, and blood flows between the hollow fibers. The loose state of the hollow fiber in the vein can be confirmed in advance by an experiment.

When inserting the artificial lung into a vein, as shown in FIG. 3, the hollow fiber bundle may be inserted in a tensioned state,
Furthermore, in order to facilitate the insertion, it is preferable to insert the artificial lung into a vein in a state of being housed in a bag. As shown in FIG. 4, the bag 16 for accommodating the artificial lung has a tube shape with a conical tip, and the tube-shaped bag has a tubular bag extending near the tip for separation (peel off). ), Or a separation line 14 formed from, for example, two rows of perforations or V-shaped cuts from the adhesive portion 13 to which one end of the tape 15 is fixed to the end. This tubular bag 16
When using, the artificial lung is stored in the tubular bag 16 (Fig. 5), and then the bag is filled with physiological saline or the like to expel air, and the bag is opened at the outlet of the artificial lung. Block the
The bag is inserted into the vein with a puncture dilator. When the artificial lung is inserted at a predetermined position and then the separation tape 15 is pulled at hand, the bag is divided at the separation line 14.
In this state, pulling the bag at hand allows the bag to be removed easily.

(Example 1) Inner diameter 200 mm, outer diameter 250 μ, and length approximately around a second tube 3 made of silicone rubber having an inner diameter of 2.0 mm, an outer diameter of 4.0 mm and a length of 36 cm.
Fig. 3 shows that 1000 porous polypropylene hollow fibers of 41 cm are arrayed, both ends are bundled so that the diameter at the ends is 10 mm, sealed with a silicone adhesive and fixed to a silicone rubber tube. I made an artificial lung. The artificial lung is stored in the tubular bag shown in FIG.
Insert the metal stylet of m into the second tube,
Expand the hollow fiber bundle into a straight line (about 40 cm), and put the end of the bag
It was closed as shown. Then, it was inserted into the aorta by puncture. When the tubular bag is removed and the stylet is removed, the contraction force of the silicone rubber second tube 3 shortens the hollow fiber bundle in the longitudinal direction, and the hollow fiber bundle has a diameter of about 35 mm in the vein. It is placed in a disjointed shape. Under this condition, flow oxygen gas into the second tube,
When a negative pressure is applied to the first tube communicating with the hollow fiber inner space, oxygen gas flows in the second tube and stays in the first header, and then flows in the hollow fiber, and the porous hollow fiber wall Oxygen is given to the blood via the outlet of the first tube. When the third tube is installed, the anticoagulant can be flown into this tube to continuously inject the anticoagulant into the blood from the second header, which can be useful for preventing thrombus formation in the artificial lung. .

(Example 2) FIG. 6 shows an example of using the device of the present invention for peritoneal dialysis. In this example, the second tube 3 has an inner diameter of 1.2 m
m, outer diameter 2.5 mm, length that has been previously curled by heat treatment
An 18 cm polyvinyl chloride tube is used. Hollow fiber 2 is crimped polysulfone membrane for artificial kidney (inner diameter 200μ, outer diameter 280μ, water permeability 15ml / min / m ² / mmHg, 8
00), and the hollow portion is filled in the adhesive fixing portion 8 at the tip of the hollow fiber bundle, and the adhesive fixing portion 8 at the rear end is opened so that the diameter is 12 mm and the length when contracted is 16 cm.

After filling the inside of the hollow fiber of this device with physiological saline, use a stylet to attach a second tube made of polyvinyl chloride.
Extends to 18 cm and punctures using a guide for abdominal wall
Introduced through 17 into the abdominal cavity. When the stylet is slowly removed, the hollow fiber bundle shrinks as the curl of the polyvinyl chloride tube recovers, and the hollow fiber bundle is placed in the abdominal cavity as a 16 cm-long indwelling device. Next, when the first tube 9 is connected to the dialysate bag 18 placed at a position higher than the patient, the dialysate is sent into the hollow fiber by the drop and further permeates the membrane to flow into the abdominal cavity. After holding the dialysate in the abdominal cavity for several hours and then placing the dialysate bag lower than the patient, a negative pressure is applied inside the hollow fiber and the dialysate in the abdominal cavity is aspirated through the membrane into the device. Collect from one tube into a dialysate bag. By using the device of the present invention, peritoneal dialysis can be effectively performed.

In this method, since the pores of the water-permeable hollow fiber have a size of about 0.01 μm, even if the dialysis side is contaminated, the tooth does not flow into the abdominal cavity and the treatment can be safely performed.

(Effect of the invention) As described above, the device of the present invention pre-stretches the hollow fiber bundle,
With the diameter of the device reduced, it is inserted into the body by the puncture method, and then the length of the hollow fiber bundle is shortened to evenly disperse each hollow fiber, and the device is placed in the body in this state. It prevents the substance from falling out of the body and expands the hollow fiber gap to increase the effective contact area with body fluids, making it possible to perform effective substance exchange (removal) with IN VIVO with relatively less trauma.

By using the device of the present invention, a new body fluid purification method by IN VIVO such as intravenous gas exchange, intravenous dialysis (over), peritoneal dialysis, etc. becomes possible.

[Brief description of drawings]

FIG. 1 is a cross-sectional view showing a state in which the device of the present invention is placed in a vein, FIG. 2 is a plan view of a stylet, and FIG.
FIG. 4 is a cross-sectional view of the device before being placed in a vein, and FIG. 4 is a perspective view of a tubular bag for accommodating the device of the present invention.
FIG. 5 is a perspective view showing a state where the device of the present invention is housed in a tubular bag, and FIG. 6 is a partial sectional view showing a state where the device of the present invention is left inside the abdominal cavity. A ... Vein, L ... Oxygenator 1 ... First header, 2 ... Hollow fiber 3 ... Second tube, 6 ... Second header 7 ... Stylet, 8 ... Adhesive fixing part 9 ... the first tube, 10 ... the cavity

Claims (1)

(57) [Claims] 1. A hollow fiber bundle having a plurality of hollow fibers, both ends of which are bundled and fixed with an adhesive, and hollow fibers are opened at least at the rear end of the bundled fixing portion, and which has an internal cavity. A first header having a conical shape is mounted, and a second header having a first tube connected to the other end of the hollow fiber bundle is mounted, and an expansion / contraction means is provided through an opening provided in a side wall of the first tube. A second tube provided with the second tube is inserted into the cavity of the first header, and the second tube is opened.
A hollow fiber type substance exchange device of the indwelling type in the body, characterized in that the tube of (1) is fixed to the focusing and fixing portions at both ends of the hollow fiber bundle.