JPH0465703B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION A. Field of Industrial Application The present invention relates to a valve device, and more specifically, to a valve device (artificial valve) for a blood pump device.

B. Prior Art In recent years, progress has been made in the development of artificial hearts for auxiliary and temporary replacement of the functions of the heart outside the body during open-heart surgery and other surgeries. For example, as shown in FIG. 6, a sac-type blood pump device 11 is connected between the right atrium and the pulmonary artery and the left atrium and the aorta of a living body's heart 10, respectively. Such blood pump devices are being researched in Japan ahead of the rest of the world, and have already been put into clinical use as auxiliary hearts.

This blood pump device 11 is of the so-called sack type, and as shown in FIG. It consists of a blood chamber 2 in the form of a flat bag to be housed. At the upper part of the blood chamber 2, a blood introduction tube 3 and a blood discharge tube 4 are formed upwardly and substantially in parallel to communicate with the blood chamber. 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 within the housing outer case 1 by this flange portion. In addition, artificial check valves 6 and 7 are installed inside each of the blood introduction tube 3 and the blood discharge tube 4 to prevent the blood 17 from flowing back. The blood 17 introduced therein is pumped out from the blood discharge tube 4. Blood pumping is
By alternately introducing and discharging fluid such as compressed air and decompressed air through the port 8 provided at the bottom of the housing outer case 1, the blood chamber repeats expansion and contraction as the external pressure of the blood chamber changes. It is what is done. Each cannula 12 and each blood conduit 3 and 4 on the blood chamber 2 side, which are connected to the heart of the living body by anastomosis, are connected to a ring-shaped flange provided from both ends of each connector 13 to the center thereof. They are inserted up to position 14 respectively.

In such a blood pump device, for example, the artificial valves 6 and 7 include disk-type artificial valves,
Ball-shaped artificial valves are also used. However, with all artificial valves, struts and cages are installed in the blood flow path to hold the movable valve body, so when blood flows, the struts and cages may disturb the blood flow, causing In some cases, blood clots may occur.

As a ball-type artificial valve without a strut or cage, an artificial valve 20 shown in Figs. 8 and 9 is used.
is possible. This artificial valve 20 has two main body parts 2.
0a and 20b are glued together, and each part has a valve seat 21 on which a ball (movable valve body) 28 can be attached and detached.
a and 21b are respectively formed. In addition, the valve seat 21
As shown in FIG. 9, a is formed by a groove 23 of a larger diameter cut in contact with both ends of a circular flow path 22 forming a blood flow path. Therefore, the flow path 22 faces the back of this groove 23, and the valve seat 21
A is formed as a substantially right-angled step on both sides of the flow path 22. Further, at the bottom of the groove 23, the inner surface 25 of the main body forms a substantially right-angled surface and is located above and below the flow path 22. On the other hand,
The valve seat 21b has a shape that seems to form part of a spherical surface, and is connected to the flow path 24 similar to the above-mentioned 22, but the ball 28 contacts the flow path 24 as shown by the dashed line. is completely blocked and backflow is prevented.

Such a ball-type artificial valve 20 has the following features.

(1) Easy to manufacture and has a small number of parts (only 3 parts). The mold for molding is also simple and inexpensive.

(2) During forward flow, the fluid 17 (for example, blood) flows toward the flow path 22 through the path 26 created between the ball 28 and the main body 20a, but at this time, the ball 28 itself is in point contact with the valve seat 21a. Therefore, especially when a backflow occurs, the ball 28 immediately moves toward the valve seat 21b, thereby preventing backflow. Therefore, response characteristics are good.

(3) Relatively good durability. For example, in an experiment using dogs, there was an actual driving experience for 92 days, and
In INVITRO's accelerated testing, there were no problems even after repeated use for over 4 months.

However, in the case of such ball-type artificial valves, the following problems still exist, and no effective solutions have been found to date.

When the end surfaces of the two main bodies 20a and 20b are butted against each other and bonded together, if even a slight misalignment occurs, a step will be created in the blood flow path, preventing smooth blood flow and causing undesirable thrombus formation. Therefore, high precision is required for bonding. However,
At the time of this bonding, the ball 28 must be housed in advance, and it is quite difficult to perform this bonding with high precision.

As a ball-type artificial valve that solves this problem, for example, one having a structure as shown in an exploded view in FIG. 5 can be considered.

That is, the first main body part 30a is provided with a female thread 37a, the second main body part 30b is provided with a male thread 37b,
A gasket 39 is inserted into the inner part of the female thread 37a of the first main body part 30a, and the female thread 37a and the male thread 37b are screwed together and tightened. With this structure, even if the ball 28 is housed in advance, the first and second main body parts 30a and 30b can be coupled with their center lines aligned with each other.

However, the packing 39 made of silicone rubber, butyl rubber, etc., becomes deformed or misaligned due to the above-mentioned tightening, resulting in gaps and protrusions, which impede smooth blood flow and cause malfunctions. Desired thrombus development is more likely to occur.

As a result of research, the present inventor succeeded in developing a valve device that does not cause the above-mentioned problems, and has accomplished the present invention.

C. Purpose of the Invention The present invention provides highly accurate and easy assembly;
Moreover, it is an object of the present invention to provide a valve device in which no undesirable gaps or protrusions are formed.

D. Structure of the Invention The present invention provides a valve device in which a movable valve body is disposed within a tubular body so as to be movable along the blood flow direction, wherein the tubular body is made up of a combination of a pair of mutually divided parts. The present invention relates to a valve device for a blood pump device, in which a packing material is previously integrally fixed to at least one of the pair of portions by gelling the packing material in a joining region of these divided portions.

Example Examples of the present invention will be described below.

FIG. 1 is a sectional view of the ball-type artificial valve, and FIG. 2 is an exploded sectional view of the same.

The artificial valve 30 has a first body part 30a with a female thread 37a, a second body part 30b with a male thread 37b, and a ball 28.
An annular packing material 38 is integrally fixed to the inner end surface of the female thread 37a of the first main body portion 30a. The valve operating mechanism is the same as that of the artificial valve shown in FIGS. 8 and 9 described above, so a description thereof will be omitted. Further, the same parts as in FIGS. 8 and 9 are designated with the same reference numerals.

The first and second main body parts 30a and 30b are made of resin such as polycarbonate, polyurethane, polysulfone, hard vinyl chloride, etc., and transparent parts with high dimensional accuracy can be easily obtained by injection molding.
The artificial valve of this example is mainly used for an artificial heart of a type used outside the body, and in this case, being able to see through the inside is an important factor in clinical management. Although it is preferable to previously provide a surface layer made of an antithrombotic material on the surfaces of the first and second main bodies 30a and 30b that come into contact with blood, this layer is not shown. The annular packing material 38 is made of a polyurethane-based antithrombotic material. As the material for the ball 28, silicone and urthane elastomer are preferably used because they have excellent antithrombotic properties.

From the state shown in FIG.
0a or a pair of screws 3 consisting of a female thread 37a and a male thread 37b housed in the second main body part 30b.
7 are screwed together, tightened, and assembled into the state shown in FIG. 1 to form the artificial valve 30. Since the annular packing material 38 is fixedly fixed to the first main body part 30a, it will not be twisted during the above-mentioned tightening process, and will be naturally compressed to prevent gaps, protrusions, etc. from forming inside. The artificial valve 30 is assembled without adding steps,
There is no risk of thrombus formation during blood flow. In addition, since the annular packing material 38 is located at a portion with a large inner diameter where the ball 28 reciprocates, the ball 28
The valve does not come into contact with the annular packing material 38, and the function of the valve is not impaired. As described above, the assembly of the artificial valve 30 is extremely simple and easy, and the inner circumferential surface is formed as a smooth continuous surface, resulting in a high-quality artificial valve.

Next, the annular packing material 3 is attached to the first main body portion 30a.
The procedure for fixing the parts 8 together will be explained with reference to FIG.

First, the silicone rubber stopper 41 is moved from the position shown by the imaginary line to the first body part 30 as shown by the solid line.
Insert the ball into the planned ball storage position a.

Next, a predetermined amount of polyurethane-based antithrombotic material solution 40 is applied to the exposed surface of the first main body portion 30a using a syringe 43 through the space between the female thread 37a and the stopper 41. supply

Once the solvent in the solution 40 has been sufficiently removed, the stopper 41
When the is pulled out from the first main body part 37a, an annular antithrombotic packing 38 is attached to the exposed surface of the first main body part 3.
It is formed integrally fixed to 0a.

The packing material 38 is formed by removing the solvent of a polyurethane-based antithrombotic material solution, and is also made of polyvinyl chloride plastisol or other liquefiable material as a raw material, and is made into a packing material by reaction gelling by heating or the like. It can be made into material 38.

In the above example, the annular packing material 38 is integrally fixed to the first main body part 30a, but instead of this, or in addition to this, a packing material is integrally fixed to the end surface of the second main body part 30b. You can let me.

A packing material is provided on the end face of the second main body portion 30b as shown in FIG. 4.

First, move the silicone rubber tubular body 42 from the position shown by the imaginary line to the second main body part 3 as shown by the solid line.
Fit externally into the female thread 37b of 0b. 42a is an annular protrusion provided on the inner peripheral surface of the tubular body to mask the female thread 37b. Next, in the same way as in the first main body part explained earlier, a plug 4 made of silicone rubber is attached.
1 is inserted into the expected ball accommodation position of the second main body portion 30b as shown by the solid line from the position shown by the imaginary line.

Next, the polyurethane-based antithrombotic material solution 40 is applied to the second body portion 30b using the syringe 43 through the space between the tubular body 42 and the stopper 41.
A predetermined amount is supplied to the end face of the

When the solvent of the solution 40 is sufficiently removed, the tubular body 42 and the stopper 41 are pulled out from the second main body part 30b, and an annular packing material ₃₈₂ is integrally fixed to the end surface of the second main body part 30b. be done.

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

In addition to the embodiments described above, various modifications are possible based on the technical idea of the present invention.

For example, the movable valve body may have a spherical shape, a conical shape, or any other suitable shape that can function as a movable valve body.

F. Effects of the Invention As explained above, in the present invention, since the tubular body is made up of a combination of a pair of mutually divided parts, the movable valve body is accommodated in the divided state in the tubular body, and then These divided parts can be combined, so that a valve device can be easily formed. Furthermore, since the packing material is integrally fixed in advance to at least one of the pair of parts in the joining area of the divided parts, the packing material does not twist or cause other undesired deformation when joining.
As a result, undesirable gaps and protrusions are not formed, the surface in contact with blood becomes smooth, blood flows smoothly, and there is no risk of thrombus formation.

[Brief explanation of drawings]

1 to 4 show an embodiment of the present invention, in which FIG. 1 shows a valve device, FIG. 1A is a sectional view taken along the center line, and FIG. FIG. 2 is an exploded sectional view of the valve device, and FIGS. 3 and 4 are sectional views showing a method of forming packing material on the divided main body portions, respectively. FIG. 5 is an exploded sectional view of another valve device. 6 to 9 show conventional examples, in which FIG. 6 is a schematic perspective view showing how the blood pump device is used, FIG. 7 is an exploded perspective view of the blood pump device, and FIG. 8 is a ball pump device. A cross-sectional view of the type artificial valve, FIG. 9 is a cross-sectional view taken along the - line arrow in FIG. 8. In addition, in the symbols shown in the drawings, 17...
Blood, 21a, 21b... Valve seat, 28... Ball (movable valve body), 30... Valve device, 30a... First main body part, 30b... Second main body part, 37a... Female thread, 37b ... Male thread, 38, 38 ₂ ... Packing material, 40 ... Packing material solution, 41, 42...
...mask, 43...syringe.

Claims (1)

[Claims] 1. A valve device in which a movable valve body is disposed within a tubular body so as to be movable along the blood flow direction, and the tubular body is composed of a combination of a pair of divided parts, and each of these divided parts A valve device for a blood pump device, wherein a packing material is integrally fixed in advance to at least one of the pair of parts in the coupling region by gelling the packing material.