JPH0423543B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION A. Field of Industrial Application The present invention relates to a blood pump device (for example, a blood pump device for an artificial heart) and a method for manufacturing the same.

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, tubular pump devices 11 as pulsating blood pumps are connected between the right atrium and the pulmonary artery and between the left atrium and the aorta of a living body's heart 10, respectively.

This blood pump device 11 is called a tubular type, and mainly includes a pressure-resistant case 1 (made of polycarbonate or polyurethane, for example).
and a cylindrical blood chamber 2 made of polyvinyl chloride that is airtightly housed within this case. Blood ejection is performed by introducing fluid, such as compressed air and reduced pressure air, through a port 8 provided in the case 1;
This is accomplished by alternately discharging the blood chamber and repeatedly expanding and contracting the blood chamber as the external pressure of the blood chamber changes. Each cannula 12 and blood chamber 2, which are connected to the heart of the living body by an anastomosis technique, are connected to each other by a connector (not shown).

An example of such a tubular blood pump device 11 is the device described in Japanese Patent Publication No. 52-8638. However, all of the known devices have a large number of component parts, making assembly difficult and having poor reproducibility, the shape of each component being complex and difficult to mold, or the polymers that make up the blood chamber. The problem is that the elastic body, especially both ends, cannot be securely and closely fixed to the case.

C. Object of the Invention The object of the present invention is to provide a blood pump device that can be assembled easily and with good reproducibility by reducing the number of parts, that each part is easy to manufacture, and that the blood chamber can be fixed tightly. The purpose is to provide a method.

D. Structure of the Invention That is, the present invention provides a cylindrical case portion (for example, a cylindrical case portion as described below) having a first opening on the blood introduction side (for example, the opening 32 described below) and a second opening on the blood outlet side (for example, the opening 30 as described below). A blood pump device in which a stretchable elastic hollow body (for example, an elastic cylindrical body 22 to be described later) forming a blood chamber is disposed from the first opening to the second opening inside the case part 21). , a built-in artificial valve (for example, a ball (movable valve body) 26, which will be described later) for connecting the elastic hollow body to a driven part (for example, the heart 10, which will be described later) to be driven in pulsation by this blood pump device. 27) tubular connector portion (for example, connector portions 20 and 23 described later),
fitted into at least one of the first opening and the second opening; the elastic hollow body is held and held between the tubular connector portion and the end of the case portion;
It further extends to the other end side of the tubular connector part, and the clamping and holding part has an outer circumferential surface position near the end of the tubular connector part and a corresponding part near the end of the case part. Annular recesses (for example, annular recesses 33A and 33B described later) are provided at the outer peripheral surface positions, and first annular tightening means (for example, tie bands 24 and 2 described later) are provided in the annular recesses of the case part.
5) is fitted, whereby a part of the elastic hollow body bites into the annular recess of the tubular connector section, and the elastic hollow body and the tubular connector section are connected near the end of the case section and between the elastic hollow body and the end of the tubular connector section. are fixed to each other, and the extending portion (for example, end portions 22a and 22b described below) of the elastic hollow body is connected to the tubular connector portion including the enlarged diameter portion of the tubular connector portion in the artificial valve built-in region. a second portion covering most of the outer circumferential surface of the elastic hollow body near the end of the extending portion of the elastic hollow body;
Annular tightening means (for example, tie band 2 described below)
8, 29) are externally fitted to fix the vicinity of the end of the extending portion of the elastic hollow body and the vicinity of the other end of the tubular connector part, and the other end of the elastic hollow body and the case This relates to a blood pump device characterized in that the two parts are fixed to each other.

Further, in the present invention, within a cylindrical case portion having a first opening on the blood introduction side and a second opening on the blood outlet side, the elastic hollow body forming the blood chamber is moved from the first opening to the cylindrical case portion. In the method for manufacturing a blood pump device disposed across the second opening, a tubular connector with a built-in artificial valve for connecting the elastic hollow body to a driven part to be pulsatilely driven by the blood pump device. a step of fitting one end of the elastic hollow body onto a large part of the outer circumferential surface of the tubular connector part including the enlarged diameter part due to the built-in artificial valve; Alternatively, the other end of the elastic hollow body is inserted into the case portion through the second opening, and further led out of the case portion through the other opening, and the tubular connector portion is inserted into the first
The outer periphery near the end of the case portion is inserted into the case portion through the opening or the second opening, and is placed in a first annular recess provided in advance on the outer peripheral surface near the case side end of the tubular connector portion. a step of matching the position of a second annular recess previously provided in the surface; and fitting a first annular tightening means into the second annular recess, thereby biting a part of the elastic hollow body into the first annular recess. a step of fixing the tubular connector part, the elastic hollow body, and the case part to each other; fitting a second annular tightening means onto the outer peripheral surface of the elastic hollow body, thereby fixing the tubular connector portion and the elastic hollow body to each other; and fixing the other end of the elastic hollow body to the case portion. The present invention also provides a method for manufacturing a blood pump device, which comprises a step of fixing the blood pump devices to each other.

E. Embodiments Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

First, with reference to FIG. 1, the configuration of a tubular blood pump device 31 according to this embodiment will be explained.

This device 31 basically includes a hard cylindrical case part 21, a blood chamber 22 disposed inside the case part, and a tubular connector part 20 for fixing both ends of the blood chamber to the case part 21.
and 23, and only requires four parts. In addition, 8 in the figure is a port for introducing and discharging compressed or decompressed air 41, 24 and 25 are tie bands provided to further secure both ends of the blood chamber 22, and 26 and 27 are artificial valves. This is a movable ball valve. Also, 2
8 and 29 are tie bands that may be provided to secure the blood chamber ends 22a and 22b fitted into the respective connector parts 22 and 23. Then, as shown in the figure, the blood chamber 22
is connected to the case part 21 by the connector parts 20 and 23.
At both ends of the blood pump device 31 fixed to the
The cannula 12 as described above is inserted and attached as shown in the imaginary line, so that when in use, blood can be guided in one direction as shown by the arrow 17.

What should be noted about this tubular blood pump device is that when fixing the blood chamber 22 as a stretchable elastic cylindrical body to the case part 21, each end 22a and 22b of the elastic cylindrical body is connected to the connector 2.
0 and 23, respectively, and each connector is inserted into the opening 30 on the blood outlet side of the case portion 21.
and the opening 32 on the blood introduction side, and at the same time, the elastic cylindrical body 22 is clamped and held at each end of the case portion 21.

Therefore, the blood pump device according to this embodiment has the following excellent advantages.

(1) In addition to having fewer components, the use of the above-mentioned clamping and holding structure makes assembly easy, and the reproducibility is good, so it can be assembled by any worker without any individual differences.

(2) Since each component has a simple shape, it is easy to mold it.

(3) Since the elastic cylindrical body 22 is clamped by the pressure of the connector parts 20 and 23, the elastic cylindrical body 22 can be fixed or clamped to the case part 21 more firmly.

(4) In addition to this, the elastic cylindrical body 22 is
1 and the connector parts 20 and 23, the blood chamber can be tightly fixed or sealed sufficiently.

The case portion 21 may be made of hard plastic such as polycarbonate, polysulfone, or epoxy resin, or metal, but is preferably transparent in order to observe thrombi and bubbles. Moreover, the elastic cylindrical body 22 is made of polyurethane, soft polyvinyl chloride,
It is preferable to use a transparent polymeric elastic material such as natural rubber, and the film thickness is preferably 0.2 to 2.0 mm.
Even better is around 1.0mm.

Elastic cylindrical body 22 with connector parts 20 and 23
As shown in FIG. 2, for example, a ring-shaped recess 33A is formed on the outer periphery of the end of the connector part 23, and the case part 21 is formed somewhat thinner at the same position. By tightening with the tie band 25, the thin part of the case part 21 is somewhat elastically deformed, and the elastic cylindrical body 22 forms a ring-shaped recess 33B on the connector part side.
Let it partially bite into 3A. Thereby, the elastic cylindrical body 22 can be more strongly clamped, and displacement of the elastic body 22 can be eliminated. For this purpose, it is preferable that the thickness of the elastic cylindrical body 22 be within the above range, and that the thickness of the case portion 21 be 3 to 4 mm, particularly approximately 2 mm at the concave portion 33B.

In addition, the connector parts 20 and 23, which also function as artificial valves (check valves), are molded from hard polyvinyl chloride, polycarbonate, acrylic resin, etc., but known antithrombotic agents such as polyurethane and siloxane can be applied. Any material may be used as long as it is transparent and allows for easy internal observation. Further, valve seats 35 and 36 are formed, respectively, on which the balls (movable valve bodies) are attached and detached. In addition, the valve seat 35 is shown in FIG. 3A.
As shown in the figure, a circular flow path 37 forming a blood flow path
It is formed by grooves 38 of larger diameter cut in contact with both ends of. Therefore, the flow path 37 faces the depth of this groove 38, and the valve seat 35 is formed as a substantially right-angled step on both sides of the flow path 37. On the other hand, the valve seat 36 has a shape that seems to form part of a spherical surface, and is connected with a flow path 39 similar to the above-mentioned 37 (see also FIG. 3B). Note that this structure also applies to the connector section 23.

In this artificial valve, as shown in Figure 1, arrow 1
When blood flows in 7 directions, use this pressure to push ball 2
6 and 27 are pressed against the valve seat 35 as shown by the solid line, but the width of the groove 38 (see FIG. 3A) is
Since the diameter of the balls 26 and 27 is smaller than the diameter of the groove 3, the balls 26 and 27 fit into the groove 3 as shown by the imaginary line in FIG. 3A.
8 only partially. Therefore, in the groove 38, a gap 40 is left between the balls 26, 27 and the connector body, which communicates with the flow path 37.
Moreover, the balls 26 and 27 are in almost point contact with the valve seat 35. Conversely, arrow 1
If a backflow of blood occurs in the opposite direction to 7,
The balls 26, 27 immediately leave the valve seat 35,
It is pressed against the other circular valve seat 36. in this case,
Since the valve seat 36 is circular and the balls 26, 27 are spherical, they are in close contact over the entire area, and the flow path 39 is completely blocked, thereby preventing blood from flowing backward.

Next, a method for manufacturing the tubular blood pump device described above will be explained with reference to FIG. However, the fourth
In the figure, tie bands 24, 25, 28,
29 and ring-shaped recesses 33A and 33B in FIG. 2 are not shown.

First, as shown in Fig. 4A, one connector part 2
0, an elastic cylindrical body 2 made of an elastic polymer material
2 in the direction of arrow 42.

Then, as shown in FIG. 4B, after one end 22a of the elastic cylindrical body 22 is attached to the connector part 20, the case part 21 is inserted into the elastic cylindrical body 22 in the direction of arrow 43.

In this state, as shown in FIG. 4C, the connector part 20 is fitted into the opening 30 of the case part 22, and the elastic cylindrical body 22a is fixedly fixed between the case part 21 and the other end of the elastic cylindrical body. 22b is guided out of the case through the opening 32. Then, the other connector part 23 is inserted into the elastic cylindrical body 22b in the direction of arrow 44, and is fitted into the opening 32 of the case part 21 as shown in FIG. The shaped body 22b is clamped and fixed. Furthermore, the tie bands 28 and 29, 24 and 25 described above are attached, respectively.

According to the manufacturing method described above, in assembling the blood pump device shown in FIG.
It is only necessary to attach the connector to the connector part 20 (or 23) and fit each connector part to the case part 21, so the work is easy and can be assembled with good reproducibility, and the shape of each part is also simple. It is advantageous because the number of points is small.

Note that when attaching the case portion 21 in the steps shown in FIGS. 4B and 4C, the inner surface of the case portion 21 and the end side 22a of the elastic cylindrical body on each connector portion 20 and
and 22b may be applied with an adhesive (not shown) to improve the adhesive force between the two.

In addition, in the above process, the ball valves 26 and 2 are placed in the connector part in advance when assembling the pump device.
7 are respectively incorporated, but these ball valves may be inserted into the connector portion in a later step. For this purpose, as shown in FIG. 5, after assembling the device in the same manner as in FIG.
The pump device is vertically immersed in a liquid 45 whose specific gravity is approximately the same as . Then, while maintaining the liquid 45 at a constant temperature to prevent convection, a syringe 46 such as a microsyringe is passed through the channel 39 from above.
A predetermined amount of the ball forming material solution 48 is gently injected through the injection needle 47 . Here, as the liquid 45, a protective colloid or surfactant such as polyvinyl alcohol, carboxymethylcellulose, methylcellulose, polyvinylpyrrolidone, or sodium polyacrylate, or a surfactant, and further an inorganic salt (for example, sodium polyphosphate) is used. You may do so. Further, it is desirable that the entire liquid 45 is maintained at a temperature of 20 to 50°C, and may be at room temperature as long as no convection occurs. In addition, the solution 48 to be injected may be a two-component room temperature curing monomer, such as a silicone solution, but may also be a monomer solution for other polyurethane or epoxy resins (however, the solvent may be other than water). ) can also be used.

In this way, the solution 48 injected from the injection needle 47
floats in the connector part 23, but because it has almost the same specific gravity as the liquid 45, it receives equal pressure from all directions, and as it stands still in a weightless state, it takes on a spherical shape and is cured as it is. As a result, a ball with a predetermined diameter and high sphericity is formed as shown by the dashed line 27 in FIG. In this way, the ball (movable valve body) 27 can be molded without any special equipment by only injecting the molding material and curing by standing, and at the same time, the connector part as an artificial valve can be manufactured by leaving it in the connector part. .

Therefore, the ball 27 can be easily placed in the valve, and balls 27 of various sizes and with good sphericity can be formed depending on the amount of material injected. This also applies to the other ball 26,
It can be molded by applying the above-described ball molding method. For example, in FIG.
After first forming the ball 26 in the lower connector part 20, the tip of the injection needle 47 is raised to the upper connector part 23, where the next ball 27 is formed.
can be molded. Alternatively, after forming the ball 27 within the connector section 23 in FIG. 5, the apparatus may be turned upside down and the ball 26 may be similarly formed within the connector section 20.

In this ball forming method, the pump device is manufactured before incorporating the ball, so the inner surface of the pump device can be coated with an antithrombotic agent or processed in advance.
Therefore, the ball can be assembled after the inner surface is smoothed and the device is finished so that thrombus does not easily form.

In addition, in this example, since the artificial valve also serves as a connector, attachment of the artificial valve becomes easy.

Although the present invention has been illustrated above, the embodiments described above can be further modified based on the technical idea of the present invention.

For example, the fitting of each of the connector parts 20 and 23 to the case part 21 described above may be performed not only by simply press-fitting, but also by employing a concave-convex fitting method (for example, a concave part is formed in the connector part, and a concave part is formed in the case part side). ) In addition, the structure, shape, size, etc. of each component may be changed in various ways. Furthermore, the manufacture of the connector portion as an artificial valve may also be modified. Connector part 2
One of 0 and 23 may be omitted and the elastic cylindrical body 22 may be fixed to the case portion 21 by a normal method. Further, in manufacturing the pump device, it is preferable to mold the ball in a so-called zero-gravity condition as shown in FIG. 5, but it is also possible to form the ball under a condition in which a certain amount of gravity is applied. The medium used is not limited to the above-mentioned liquid 45, and may be other media. Note that the present invention can also be applied to blood pump devices other than the above-mentioned tubular type.

F. Functions and Effects of the Invention As described above, the present invention provides that when the blood chamber (elastic hollow body) is fixed to the case part, the connector is fitted into the opening of the case part, and at the same time, the elastic hollow body is attached to the end of the case part. Since it is designed to be clamped and held, the number of components is small, and the above-mentioned clamping and holding structure makes assembly easy, and the reproducibility is also good, so it can be easily assembled by different operators. Can be assembled. In addition, since each component has a simple shape, it is easy to mold it, and
Since the elastic hollow body is clamped by the pressure of the connector portion, the elastic hollow body can be more firmly fixed to the case portion. In addition, since the elastic hollow body is also used as a gasket for fitting the case part and the connector part, the blood chamber can be tightly fixed or sealed sufficiently.

Furthermore, the extending portion of the elastic hollow body covers most of the outer circumferential surface of the tubular connector portion, the extending portion of the elastic hollow body covers the enlarged diameter portion of the tubular connector portion due to the built-in artificial valve, and the case portion and the tubular connector portion. By tightening the first annular tightening means at the position of the annular recess of the elastic hollow body and tightening the vicinity of the end of the elastic hollow body with the second annular tightening means, the above-mentioned fixing and sealing are ensured and reliability is increased. .

[Brief explanation of drawings]

1 to 5 show embodiments of the present invention, in which FIG. 1 is a sectional view of a tubular blood pump device, and FIG. 2 is an enlarged cross-sectional view of a part of FIG. 1. Figure 3A is a cross-sectional view taken along the line A-A in Figure 1, Figure 3B is a cross-sectional view taken along the line B-B in Figure 1,
FIGS. 4A, 4B, and 4C are cross-sectional views showing the method for manufacturing an artificial valve in order of process, and FIG. 5 is a cross-sectional view showing the ball valve forming process. FIG. 6 is a schematic diagram showing how the tubular blood pump device is used. In addition, in the symbols shown in the drawings, 12... cannula, 17... blood, 20, 23... connector part, 21... case part, 22... elastic cylindrical body (blood chamber), 24, 25, 28, 29... Tie band, 26, 27... Ball (movable valve body) 3
0, 32...opening, 33A, 33B...ring-shaped recess.

Claims (1)

[Scope of Claims] 1. Inside a cylindrical case portion having a first opening on the blood introduction side and a second opening on the blood outlet side, a stretchable elastic hollow body forming a blood chamber is connected to the first opening. In the blood pump device disposed from the to the second opening, a tubular connector portion with a built-in artificial valve for connecting the elastic hollow body to a driven portion to be driven in pulsation by the blood pump device is provided. , fitted into at least one of the first opening and the second opening; the elastic hollow body is sandwiched and held between the tubular connector portion and the end of the case portion; The clamping and holding portion has an annular shape at an outer circumferential surface position near the end of the tubular connector portion and a corresponding outer circumferential surface position near the end of the case portion, respectively. A recess is provided, and a first annular tightening means fits into the annular recess of the case part, whereby a part of the elastic hollow body bites into the annular recess of the tubular connector part and tightens the end of the case part. the elastic hollow body and the vicinity of the end of the tubular connector portion are fixed to each other; covering most of the outer circumferential surface of the tubular connector portion including a second
An annular tightening means is externally fitted to fix the vicinity of the end of the extension part of the elastic hollow body and the vicinity of the other end of the tubular connector part, and the other end of the elastic hollow body and the case part are fixed to each other. A blood pump device characterized in that: and are fixed to each other. 2. Inside a cylindrical case portion having a first opening on the blood introduction side and a second opening on the blood outlet side, a stretchable elastic hollow body forming a blood chamber extends from the first opening to the second opening. In the method for manufacturing a blood pump device, the above-mentioned tubular connector part with a built-in artificial valve for connecting the elastic hollow body to a driven part to be pulsatilely driven by the blood pump device is provided. a step of fitting one end of the elastic hollow body onto most of the outer circumferential surface of the tubular connector portion including the enlarged diameter portion due to the built-in artificial valve; the other end of the elastic hollow body is inserted into the case part, and further led out of the case part through the other opening, and the tubular connector part is inserted into the first case part.
The outer periphery near the end of the case portion is inserted into the case portion through the opening or the second opening, and is placed in a first annular recess provided in advance on the outer peripheral surface near the case side end of the tubular connector portion. a step of matching the position of a second annular recess previously provided in the surface; and fitting a first annular tightening means into the second annular recess, thereby biting a part of the elastic hollow body into the first annular recess. fixing the tubular connector portion, the elastic hollow body, and the case portion to each other; fitting a second annular tightening means onto the outer circumferential surface of the body, thereby fixing the tubular connector portion and the elastic hollow body to each other; and connecting the other end side of the elastic hollow body to the case portion. A method for manufacturing a blood pump device, comprising the step of fixing the two to each other.