JPH067695Y2 - Medical valve device built-in connector - Google Patents

Description

[Detailed Description of Device] a. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical valve device built-in connector, for example, a medical valve device built-in connector for connecting a cannula with a blood introduction tube or a blood discharge tube of an artificial heart.

B. 2. Description of the Related Art In recent years, development of an artificial heart for assisting and temporarily replacing the function of the heart outside the body at the time of surgery of interest or other surgery has been advanced. For example, as shown in FIG.
Suck-type blood pump devices 11 are connected between the right atrium and the pulmonary artery of the living heart 10 and between the left atrium and the aorta, respectively.

Such a blood pump device 11 is called a sack type, and as shown in FIG. 8, it is mainly composed of a pressure-resistant (for example, polycarbonate or polyurethane) housing outer case 1 and a housing outer case. It is composed of a flat bag-shaped sack-shaped blood chamber 2 which is hermetically housed. A blood introducing tube 3 and a blood discharging tube 4 are formed above the blood chamber 2 so as to communicate with the blood chamber and face upward and substantially parallel to each other. A flange portion 5 forming a part of the housing is provided around the upper portion of the blood chamber portion, and the blood chamber is hermetically housed in the housing outer case 1 by this flange portion. Further, in each of the blood introducing tube 3 and the blood discharging tube 4, an artificial check valve 6, which prevents the reverse flow of the blood 17, is provided.
7 is attached, whereby the blood 17 introduced into the blood chamber 2 from the blood introduction tube 3 is transferred to the blood discharge tube 4
It's getting better. For the ejection of blood, a fluid such as compressed air and decompressed air is alternately introduced and exhausted through a port 8 provided at the bottom of the housing outer case 1, and the blood chamber expands and contracts in accordance with the change in the external pressure of the blood chamber. It is done by repeating. The cannula 12 and the blood conduits 3 and 4 on the blood chamber 2 side, which are connected to the heart of the living body by the anastomosis (fungo) technique, are provided with ring-shaped flanges 14 provided at the central positions from both ends of each connector 13. It is inserted to each position.

In such a blood pump device, for example, a disc-type artificial valve and a ball-type artificial valve are also used as the artificial valves 6 and 7. In particular, the ball type has the advantages that it has better durability and less thrombus formation than the disk type because the movable valve is made of a ball.

Up to now, all artificial valves clinically used for assist artificial hearts are diverting expensive ones for transplantation.
Particularly, in Japan, more than 80 cases have already been clinically conducted, but all of them are diverted from commercially available implantable disc valves, and the problem of valve cost has become apparent as the practical use increases. .

Since all of the clinical examples of this are extracorporeal assist artificial hearts, the cannula 12 of FIG. 7 is used, and the artificial valves have a structure in which one blood conduit 3 and one blood conduit 4 are incorporated. ing. In addition, the cannula 12 and the blood pump device 1
The connector 13 is always used to connect 1.
On the other hand, since the artificial valve is incorporated into the blood conduits 3 and 4 as described above, the molding and assembly of the blood pump device 11 are complicated, and the cost of the blood pump device is high. Therefore, if the valve seat and the movable part of the artificial valve can be incorporated into the connector 13, these problems can be solved all at once, but such a structure has not yet been put to practical use.

C. The purpose of the present invention The present invention has been made in view of the above circumstances,
It is an object of the present invention to provide a valve device which has excellent antithrombogenicity and durability and is easy to manufacture.

D. Configuration of the Invention The present invention comprises a connector body (for example, an upstream tubular body 22 and a downstream tubular body 27, which will be described later) that connects the first blood conduit at one end and the second blood conduit at the other end, respectively. ) And a movable valve body (for example, a ball 28 described later) movably arranged along the connector body so as to be movable in the blood liquid flow direction.
A movable valve body accommodating means (for example, a cage 24 described later) that accommodates the movable valve body in a state in which the blood can flow, and the movable valve body accommodating means is separated from the connector body by a hard material. A fixing part (for example, an annular fixing part 24a described later) that is made in a body and is tightly fixed to the wall surface of the recess formed in the connector body via packing, and is integrally incorporated in the connector body. The present invention relates to a connector with a built-in valve device for medical use.

E. Embodiments Embodiments of the present invention will be described below.

FIG. 1 is a sectional view taken along the center line (not shown) of a connector having a function as a check valve.

The connector 21 has an upstream tubular body 2 having a valve seat 23.
2. A ball accommodating portion (called a cage) 24 having four cage rods 24b extending from the annular fixing portion 24a and connecting at the tips, a downstream tubular main body 27, and a ball (movable valve element) 28. Composed.

FIG. 2 is an enlarged perspective view of the cage 24.

A first enlarged diameter portion 27b having an enlarged inner diameter is provided on the upstream end side of the downstream main body 27, and a female screw 27a is provided on the distal end side of the first expanded diameter portion 27b. A male screw 22a is provided on the distal end side on the downstream side of. The male screw 22a and the male screw 27a are screwed together, and the upstream main body 2
2 end surface 22b and the first expanded portion 27b of the downstream main body 27.
To the recess formed between the bottom surface 27c of the
The annular fixing portion 24a of the cage is sandwiched via A and 26B, the cage fixing portion is tightly fixed by tightening the screws 22a and 27a, and the connector 21 is assembled. A second enlarged diameter portion 27d having an enlarged inner diameter is provided in the downstream main body 27 at approximately the center of the connector 21, and the four rod bodies 24b of the cage 24 are housed in the second enlarged diameter portion 27d. A ball 28 is accommodated in 24.

The four rods 24b of the cage 24 have balls 28 on the tip side.
The ball receiving portion 24c is formed by being bent so as to correspond to the spherical surface and is joined at the tip.

When the blood 17 flows in the connector 21 as shown by the arrow,
The ball 28 has a ball receiving portion 2 as shown by a solid line in FIG.
The blood 17 abuts against 4c and flows between the second enlarged diameter portion 27d and the four rod bodies 24b without causing a turbulent flow, and there is no possibility of thrombus generation. This is because the packings 26A and 26B eliminate the gap. Further, since the blood 17 is a pulsatile flow, the ball 2
8 is moved to the upstream side while being surrounded by the four rod bodies 24b and comes into contact with the valve seat 23 of the upstream side main body 22 in the spherical annular region as shown by the phantom line, so that the reverse flow of the blood 17 is promptly prevented. It The packings 26A and 26B play a role of reducing the water hammer value by relaxing the impact of the ball 28 colliding with the valve seat 23 or the ball receiving portion 24c together with the sealing of the blood 17. Further, since the cage 24 is tightly fixed to the concave wall surface of the connector body by the annular fixing portion 24a via the packings 26A and 26B, it is firmly supported by the connector body.

The material of the main bodies 22 and 27 was polycarbonate. In addition, hard vinyl chloride, polyurethane, epoxy resin,
Polysulfone, acrylic resin, nylon (transparent), etc. can be used. The ball 28 is made of silicone having a specific gravity of 1.03. In addition, polyacetal, polycarbonate,
Polysulfone, polyurethane, nylon 6, poly 4-methylpentene 1, polypropylene and the like can be used. The cage 24 is made of stainless steel and integrally manufactured by an investment method (for example, lost wax method) which is a precision casting method. As the material of the cage 24, titanium and non-corrosive metals other than the above can be used, and a hard material (for example, high-strength plastic reinforced with carbon fiber or the like) other than metal produced by an appropriate method may be used. .

As described above, the tubular portion of the connector 21 is composed of three parts, that is, the upstream main body 22, the cage 24, and the downstream main body 27, which are separately manufactured, so that the material of the cage 24 can be a desired material having excellent impact strength. Damage to the ball receiving portion 24c of the cage due to the collision of the ball 28 can be reduced, and the durability can be improved. Further, the valve seat 23 can be precisely finished before assembling, which facilitates quality control. Further, since the connector can be assembled after the balls 28 are loaded into the cage 24, the connector 2 of the balls 28 can be assembled.
It is easy to load into 1.

Further, the movement of the ball 28 is performed within the cage 24 in the enlarged diameter portion 27d having a shape capable of forming a streamline close to a laminar flow, so that the ball 28 is moved by the valve seat 23 or the ball receiving portion 24.
the ball 28 in the radial direction of the connector when leaving c
The movement of the ball is small, and the ball 28 moves smoothly and quickly when the blood circulation and the circulation stop, so that good response characteristics of the ball can be obtained.

The packings 26A and 26B may be fixed to the upstream main body 22 and the downstream main body 27, respectively.

FIG. 3 is a cross-sectional view showing a procedure in which a packing (26B in FIG. 1) is fixedly attached to the bottom portion of the expanded diameter portion 27b of the downstream main body 27 and integrally provided.

First, the silicone rubber stopper 41 is inserted into the expanded diameter portion 27b of the downstream main body 27 from the position shown by the phantom line in a state of being separated from it, as shown by the solid line.

Next, the polyurethane-based antithrombotic material solution 40 is placed on the exposed surface of the bottom of the expanded diameter portion 27b using a syringe 45 via the space sandwiched between the expanded diameter portion 27b and the stopper 41. Supply a fixed amount.

When the solvent of the solution 40 is sufficiently removed, the stopper 41 is pulled out from the downstream main body 27, and the antithrombogenic annular packing 26B is integrally fixed to the downstream main body 27 on the exposed surface.

The packing material 26B is formed by removing the solvent of the polyurethane-based antithrombotic material solution, and is made of polyvinyl chloride plastisol or other liquefiable material as a raw material, and the reaction material is gelled by heating or the like to form the packing material. 26B.

FIG. 4 is a cross-sectional view showing the manner in which a packing (26A in FIG. 1) is fixedly attached to the end surface of the upstream main body 22 on the male screw 22a side and integrally provided.

First, from the position shown by the phantom line to the tubular body 42 made of silicone rubber, as shown by the solid line, the male screw 22a of the upstream main body 22
And the male screw 22b is masked. Next, as in the case of the downstream main body described above, the silicone rubber plug 43 is fitted into the upstream main body 22 from the position shown by the phantom line as shown by the solid line.

Next, a predetermined amount of the polyurethane-based antithrombotic material solution 40 is supplied to the end surface 22b of the upstream main body 22 using the syringe 45 via the space between the tubular body 42 and the stopper 43.

When the solvent of the solution 40 has been sufficiently removed, the tubular body 42 and the plug 43 are pulled out from the downstream main body 22 to remove the upstream main body 22.
An annular packing material 26A is integrally fixed to the end surface of the.

As described above, the work of integrally providing the packing material to the main body portion does not require special equipment and can be easily and easily performed.

When tightening the screw at the time of assembling the connector, the packing may be deformed or misaligned so as to form a gap or a convex portion, which may impede the smooth flow of blood and cause undesired thrombus. By fixing the packing to the main body and integrally providing it as described above, such a problem does not occur.

The upstream main body 22 and the downstream main body 27 may be coupled by screwing as described above, or by bonding or press fitting as a fitting method.

FIG. 5 is a sectional view taken along the center line (not shown) of the connector 31 according to another example.

A cage housing space 32a having an enlarged inner diameter for housing the cage 24 is provided substantially in the center of the tubular body 32, and a valve seat portion 33 is integrally incorporated on the upstream side of the cage housing space 32a. The tip 33a of the valve seat portion 33 is finished so that the ball 28 contacts in a spherical annular region. A cage 24 similar to that shown in FIGS. 1 and 2 is integrally incorporated on the downstream side of the ball storage space 32a. At both ends of the main body 32, tubular bodies 37, 37 for connecting the other blood conduits (for example, the blood introducing tube 3 or the blood discharging tube 4 and the catheter 12 shown in FIGS. 7 and 8) are projected from the end faces. It is integrated as one.

The material of the main body 32 is epoxy resin,
Liquid processable materials such as polyurethane can be used. The material of the valve seat portion 33 is stainless steel, and
Polycarbonate, polysulfone, etc. can be used. The material of the tubular bodies 37, 37 is stainless steel, and in addition, titanium or a non-corrosive metal can be used. Ball 2
The material of 8 and the material of the cage are the same as in the connector of FIG. 1 described above. The flow of blood 17 and the prevention of backflow are also the same as in the connector of FIG.

The valve seat portion 33, the cage 24, and the tubular bodies 37, 37 are produced in advance, and these are integrally assembled to the main body 32 by a casting method when the main body 32 is molded. Also, the cage 24
Packings 36A and 36B are provided between the main body 32 and the main body 32.

The balls 28 of the connector shown in FIGS. 1 and 5 can be manufactured as follows.

FIG. 6 is a cross-sectional view showing the procedure for ball production.

A liquid 52 having a specific gravity substantially the same as that of a molding material solution (or the ball itself) for molding a ball described later is contained in the tank 51. Then, while maintaining the liquid 52 at a constant temperature so as not to generate convection, a predetermined amount of the ball molding material solution 28 is gently injected from above from an injection needle 56 of a syringe 55 such as a microsyringe. Here, as the liquid 52, a protective colloid such as polyvinyl alcohol, carboxymethyl cellulose, methyl cellulose, polyvinyl pyrrolidone, sodium polyacrylate or a surfactant,
Further, those obtained by adding an inorganic salt (for example, sodium polyphosphate) may be used. Also, the liquid 52 is 20 to 50
It is desirable to keep it at 0 ° C, and it may be at a high temperature if it does not cause convection. Also, the above-mentioned injected solution 28
A two-part room temperature curable monomer such as a silicone solution may be used, but a monomer solution for another polyurethane or epoxy resin (provided that the solvent is other than water) can also be used.

In this way, the solution 28 injected from the injection needle 56 floats in the liquid 52, but because it has almost the same specific gravity as the liquid 52, it receives uniform pressure from all directions, and becomes spherical while still standing in a state of zero gravity. , It can be cured as it is. As a result, a ball having a predetermined diameter and a high sphericity is formed as shown by the chain double-dashed line 28 in FIG. Thus, the ball (movable valve body) 28 is molded only by pouring a molding material and static curing without a special device, and does not require a precise surface finish.

In a conventional medical device, an artificial valve for transplantation has been diverted. This artificial valve is designed so that it can be used as long as a living body (for example, a human being) is alive, and is of extremely high quality and extremely expensive, with a durability of ten years or more. Therefore, the conventional valve device used in vitro is rarely used for several weeks or more, and it is extremely excessive in quality. On the other hand, the valve device using the ball manufactured by the above-mentioned method has an extremely low manufacturing cost as compared with the conventional valve device and has sufficient durability.

In addition to the above embodiments, various modifications can be made based on the technical idea of the present invention. For example, the number of rods of the cage may be three, five or more in addition to four, and the container for accommodating the balls may accommodate the balls in addition to the cage so as to be movable along the blood flow direction. In addition, other suitable shapes that allow blood to flow can be used. Further, the movable valve body may have a spherical shape, a conical shape, or any other suitable shape capable of functioning as a movable valve body.

F. Effects of the Invention As described above, in the medical valve device built-in connector according to the present invention, since the movable valve body accommodating means for accommodating the movable valve body is made of a hard material, damage due to collision of the movable valve body is caused. Is remarkably reduced, and the movable valve body is positionally regulated by the movable valve body accommodating means, the movement from the regular position to another position is reduced, and the movable valve body is opened by the movement,
The closing operation is smooth and the response is fast. Further, since the movable valve body accommodating means is manufactured separately from the connector main body and incorporated into this main body, high-precision finishing of the valve seat can be performed before the assembling, and the finishing is facilitated. . As a result, the durability is remarkably improved, the manufacturing is facilitated, and the manufacturing cost is low. Further, since the movable valve body accommodating means is closely fixed to the wall surface of the concave portion of the connector main body through the packing at the fixing portion, this fixing is strong and highly reliable. Further, due to the presence of the packing, the impact when the movable valve body collides with the movable valve body housing means is relaxed.

[Brief description of drawings]

 1 to 6 show an embodiment of the present invention, in which FIG. 1 is a sectional view taken along the center line of a connector, FIG. 2 is an enlarged perspective view of a cage, and FIGS. Is a cross-sectional view showing the procedure for producing packing, FIG. 5 is a cross-sectional view taken along the center line of a connector according to another example, and FIG. 6 is a cross-sectional view showing the procedure for ball molding. FIGS. 7 to 8 show a conventional example, FIG. 7 is a schematic view showing a usage state of the blood pump device, and FIG. 8 is an exploded perspective view of the blood pump device. In addition, in the code | symbol shown by drawing, 17 ... blood 21,31 ... connector 22 ... upstream main body 23,33 ... valve seat 24 ... cage 24a ... annular fixing part 24b ... rod body 24c ... Ball receiving portion of cage 26A, 26B, 36A, 36B ... Packing 27 ... Downstream main body 28 ... Ball (movable valve body) 37 ... Tubular body.

Claims (1)

[Scope of utility model registration request] 1. A connector body for connecting a first blood conduit at one end side and a second blood conduit at the other end side, and a movable body movably arranged in the connector body along the blood flow direction. It has a valve body and a movable valve body accommodating means for accommodating the movable valve body in a state where the blood can flow, and the movable valve body accommodating means is made of a hard material separately from the connector body. A connector having a built-in valve device for medical use, which has a fixing portion that is closely fixed to a wall surface of a recess formed in the connector body via a packing, and is integrally incorporated in the connector body.