JPS6185953A - Blood conduit connection device - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION A. Field of Industrial Application The present invention relates to a connection device exclusively for fluids, and relates to a device suitable for a pump device for an artificial organ such as a blood pump device for an artificial heart.

BACKGROUND OF THE INVENTION 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. 10, a sac-type blood pump device 11 is placed between the right atrium and the pulmonary artery of the living body's heart, and between the left atrium and the aorta.
are concatenated. This kind of blood pump device is being researched in Japan ahead of the rest of the world, and the long-term survival record using goats exceeded 300 days for the first time in the world, and extremely good results have been obtained, and it has been used as an auxiliary heart for patients. The path to clinical application is about to be opened.

By the way, a particular problem that arises when an artificial heart is used for a 9g bed is the problem of thrombus formation inside the artificial heart.

How to impart antithrombotic properties is considered to be an extremely difficult problem, and issues such as material, pump design, surface smoothness, and blood pump operation, as well as blood flow patterns within the blood chamber, are considered to be extremely difficult problems. It is thought that the problems are involved in a complex manner.

As a result of the inventor's intensive study of these problems, 1
One serious problem is that in the operating condition shown in FIG. When they are connected to each other, it is difficult to make this connection sufficiently, and the blood inlet tube 3 and the discharge tube 4 bulge at the end of the connector, especially when the pump pump is pulsating, and a minute gap is created between the connector and the blood flow. It has been found that blood clots may occur due to disturbance of blood flow, platelets etc. adhering to the gaps. Attempts have been made to prevent the above situation by tightening the circumferential surface of the connector with a cable tie, but the reality is that only unsatisfactory results are obtained.

OBJECTS OF THE INVENTION An object of the present invention is to enable sufficient and reliable connection of conduits by connectors in devices such as the above-mentioned blood pump device, and with an N-type structure.

21 Configuration of the Invention In other words, the connecting device for a fluid conduit (e.g., a dedicated blood conduit) according to the present invention includes a first dedicated fluid conduit (e.g., the blood introduction pipe 3 described above or below) extending from, for example, a fluid chamber (e.g., a blood chamber 2 described below). and a blood discharge pipe 4), and a second fluid conduit (which is led from a driven part (for example, the aforementioned living body's heart 10) to be driven perpendicularly through this first fluid conduit.
For example, in a fluid conduit connecting device configured such that the cannula 12) and the cannula 12) described above and the cannula 12) are inserted from both ends of a tubular connector (for example, the connector 13 described above or later) to be connected to each other, A protrusion (for example, a ring-shaped flange 14, which will be described later) is provided at an intermediate position between both ends of the connector along the circumferential direction of the connector, and the connector is a tubular clamp that clamps the first and second fluid conduits and the connector. Attachment means (for example, attachment fittings 15 and 16 having a C-shaped cross section described later)
) extends to both ends of the connector while being in contact with the protrusion and being positionally regulated by the protrusion, and tightening the central attachment means to the connector at least near both ends. means (for example, cable tie 1 described below)
9.20) is provided.

E. Example Hereinafter, an example in which the present invention is applied to a blood pump device for an artificial heart will be described in detail with reference to FIGS. 1 to 8.

FIG. 1 is an exploded perspective view of a blood pump device according to a first embodiment of the present invention.

This blood pump device is called a sack type,
It mainly consists of a pressure-resistant housing outer case 1 (made of polycarbonate or polyurethane, for example), and a flat sack-shaped blood chamber 2 that is hermetically housed within the housing outer case. A blood introduction pipe 3 and a blood discharge pipe 4 are formed in the upper part of the blood chamber 2 so as to communicate with the blood chamber and extend upward and substantially parallel to each other. Around the top of some of the blood chambers,
A flange portion 5 forming a part of the housing is provided, and the blood chamber is hermetically housed within the housing outer case 1 by means of this flange portion. Further, a known check valve 6.7 is installed inside each of the blood introduction tube 3 and the blood discharge tube 4 to prevent backflow of the blood 12. Blood introduced within? (117 is adapted to be ejected from the blood evacuation bone 4. +l+ is ejected from the blood ejection bone 4 by introducing and ejecting fluid such as compressed air through a boat 8 provided at the bottom of the housing outer case 1. This is done by repeating the expansion and contraction of the blood chamber in response to changes in the external pressure of the blood chamber.

What is important here is that each cannula 12 connected to the heart of the living body and each blood conduit 3 and 4 on the blood chamber 2 side are moved from both ends of each connector 13 to its central position, as shown in FIG. A fastening fitting 1 having a C-shaped cross section is inserted up to the position of a ring-shaped flange 14 provided in each side, and is configured to be elastically deformable by slots 8 formed in the longitudinal direction.
5.16, the cannula 12 and each private tube 3.4 are tightly clamped between the connector 13, and these clamping fittings 15.16 are firmly tightened by the binding hand 19.20. This structure will be explained in further detail.

First, as shown in FIGS. 1 and 2, the cannula 12 inserted onto the connector 13 and the clamping fittings 15 and 16 that clamp each conduit 3.4 are brought into contact with the flange 14 of the connector 13, respectively. A binding band 19.20 is disposed in a cylindrical recess 21.22 extending from the position at which the connector 13 is connected to the tapered end position of the connector 13, and provided between the two positions. As shown in FIG. 3, the binding bands 19 and 20 are wound around the fastening fittings 15 and 16, and are formed to securely fasten each of the fittings 15 and 16 in a known manner.

Therefore, the length 7!1 of each one unattached fitting 15.16 is the length 12!1 between the flange 14 of the connector 13 and each end.
Therefore, when each clamping fitting 15, 16 is brought into contact with the flange 14, the position of each end is precisely aligned with the position of each end of the connector 13 while the position is regulated by this flange. This resulted in the prevention of thrombus formation at the end of the connector, as will be described later. For this reason, even if the conduit 3 (or 4) swells as shown by the dashed-dotted line during pulsation when the pump is used as shown in FIG. 4, and a minute gap is created between it and the connector 13, this In this position, the conduit 3 (or 4) is firmly attached to the connector 13 by tightly tightening the metal fitting 15 with the binding band 19, so that the above-mentioned black;
There are no small gaps. At this time, Coifta 1:
It is important that the 018 part of the clamping bracket and the 018 part of the clamping bracket are completely damaged.If the fixed length of the clamping bracket is even slightly shorter than the connector end, it is important to make sure that there is a small gap between the connector and the conduit during pulsation. This results in the formation of a ring-shaped thrombus in the circumferential direction of the connector end due to the adhesion of platelets and the like. On the other hand, if the fixed length of the fastener is longer than the end of the connector, the dedicated pipe made of elastomer polymer material fitted to the connector may cause a creep phenomenon as a result of partial crimping from the outside over a long period of time. However, the inner surface of the conduit portion, which is longer than the connector end and is held between the metal fittings on the outside, deforms and protrudes into the flow path, forming a stagnation portion and causing thrombus formation.

In addition, when tightening with a cable tie, the force acts as a uniform fastening force over almost the entire area of the connector 13 via the unattached metal fittings 15 and 16, and also on the cannula 12 side, there is a small gap as described above. Since this does not occur, the cannula 13 and each conduit 3.11 can be uniformly and firmly connected by the connector 13.

As a result, the occurrence of thrombi as described above can be prevented, and the blood pump device can be operated for a long time.

FIG. 5 shows a second embodiment of the invention.

In this example, compared to the example shown in FIG.
16 are integrally connected, and this connecting portion 23 is shaped so as to be tightly fitted to the flange 14 of the connector 13, and by this fitting, the entire metal fittings 15 and 16 are positioned, and the end position is always fixed to the connector. It is made to match the both end positions of 13.

Therefore, in the example shown in FIG. 5, the positioning of the clamping fittings is more complete and closer to the front wheel.

FIG. 6 shows a third embodiment of the invention.

In this example, a corresponding small concave portion 24 and a small convex portion 25 are provided in a ring shape on the facing surfaces of the connector 13 and each (coming fitting 15, 16). By making the cannula 12 and conduit 3.4 to be attached elastically deformably bite against the small recess 24 and small convex part 25G:', the clamping force is further increased, and the cannula 12 and the conduit 3.
4 can be sufficiently prevented from leaving.

The shape, number, size, etc. of the small concave portions and small convex portions may be selected variously.

FIG. 7 shows a fourth embodiment of the present invention.

In all of the first to third examples described above, a taper is formed at both ends of the connector 13 from the inner circumferential surface to the outer circumferential surface, so the inner circumferential surface of the connector 13 is reduced by this taper (commonly known as an inner taper). As a result of having to be located inward from the inner circumferential surface of each sound 3.4 or 12, a step is created in the flow path, resulting in separation of the flow and the like, making it easy to generate a thrombus. On the other hand, in the seventh example, by forming the taper in the opposite shape, that is, forming an inclined surface from the outer peripheral surface to the inner peripheral surface of the connector 13 (commonly known as an external taper), the connector 13 is The level of the inner peripheral surface and the inner peripheral surface of the container tube 3.4 or 12 can be matched. As a result, blood flow becomes smoother, and the effect of preventing blood clots is greatly improved.

However, in the example shown in FIG. 7, the container tube 3.4 or 12 easily comes off from the connector 13, so to prevent this,
For example, a small convex portion 2 is formed on the opposing surface of 3 and the fastening fitting 15 and 16.
6. Small recesses 27 are formed correspondingly, and the container tube 3.4 is inserted into these.
Or 12 is elastically deformed.

FIG. 8 shows another example of the clamping fitting, which is a modification of the example shown in FIG. 5.

That is, the first fitting is integrated as in Fig. 5, but another fitting is prepared which is symmetrical to the fitting shown in Fig. 8, and both fittings are applied onto the connector from both sides. The whole is formed into a substantially cylindrical clamping fitting, and the above-mentioned binding hands are arranged in the recesses 21 and 22 provided near both ends,
Both fittings can be tightened onto the connector. At the intermediate position of these pair of metal fittings, there is a positioning bulge (or connecting portion) that fits into the above-mentioned flange 14 of the connector.
23 are provided.

In the example shown in Fig. 8, if a pair of clamping metal fittings having the shape shown in the figure are used, the same clamping force as described above can be exerted, and at this time, the tightening force with the binding hands is applied near both ends of the clamping metal fittings. Sufficient clamping force can be obtained by simply doing this. Furthermore, when transparent materials are used for both the conduit 3.4 or 12 and the connector, it is possible to widen the field of view of blood flow in the connector portion, and to prevent areas that cannot be inspected for air bubbles or thrombus formation.

FIG. 9 shows a modification of FIGS. 2 and 8.

That is, each clamping fitting 15 or 16 shown in FIG. 2 is shaped as shown in FIG. 8 and used in the same manner as described in FIG. A recess 21 (or 22) for receiving a binding band is formed in each of the recesses 21 (or 22). Therefore, it may be tightened with the tying hand, or there may be a total of 4 locations on the opposite side of the IQ of the connector (each tube has 3 prongs or 4.1
2), the fixing force of the container is further increased, and it is also possible to widen the observation field of blood flow as in the example shown in FIG. 8.

On each side described above, the material of the connector may be a hard resin such as epoxy resin or polycarbonate, or a metal such as stainless steel. Furthermore, the clamping fittings may be made of metal such as aluminum, or may be made of synthetic resin such as epoxy resin.

The above-mentioned container tube 3.4.12 and the blood chamber 2, that is, the parts that come in contact with blood, can be made of an elastic polymeric material, and soft polyvinyl chloride or polyurethane is preferable as the material. In this case, the flexible polyvinyl chloride may be molded with a so-called polyvinyl chloride paste consisting of polyvinyl chloride and a plasticizer composition. When the blood chamber 2 is made of soft polyvinyl chloride, the film thickness of the blood chamber 2 is preferably 0.3 to 2.01, and 0.6 from the viewpoint of its repulsion characteristics and fatigue resistance. ~
A thickness of 1.2 mm is historically preferable. Alternatively, if the blood chamber 2 is made of polyurethane material, 0
．． II thickness of 2 to 1.51 is preferred, and 0.5 to 1.
0 dragon is more preferable. If this thickness is too large, when pressurization or residual pressure is applied inside the housing outer case 1,
Since the operation timing of the blood chamber 2 is delayed and its deformation time is extended, appropriate blood pumping behavior cannot be obtained. On the other hand, if this film thickness is too thin, the deformation behavior of a portion of the blood chamber becomes sensitive, making it difficult to control, and on the other hand, there is also a risk of breakage if the blood chamber is driven with excessive pressure.

As the check valve 6.7 used in the above embodiment, a known or commercially available valve can be used.

Such known or commercially available valves include ball type, disk type, leaflet type, central flow type, and the like.

In the blood pump device of the above embodiment, the surface that comes in contact with blood is coated with a substance having excellent antithrombotic properties.
Compatibility with blood can be improved. For example, surface treatment with dimethylsiloxane, coating treatment with a block copolymer of polyether polyurethane-polydimethylsiloxane, etc. may be performed.

Further, the housing outer case 1 is made of hard polyvinyl chloride, polycarbonate, polysulfone, etc. since strength and transparency are required.

The present invention has been exemplified above, but the above-mentioned examples do not reflect the technique of the present invention.
Further modifications are possible in line with the idea of t.i.

For example, the materials, shapes, sizes, etc. of the connectors and one-piece fittings described above may be changed in various ways. For example, the above-mentioned flange 14 does not need to be provided all around, but may be provided intermittently. Moreover, other than the illustrated binding band may be used as the binding tool. Further, the present invention is applicable to blood pump devices other than the sack type, and further to other devices than the artificial heart, such as an artificial heart-lung device.

1. Effects of the Invention As described above, the present invention provides a protrusion at the intermediate position of the connector that connects the first and second fluid pipes, and settles each pipe (the central attachment means connects the protrusion). 1. extends to both ends of the connector while in contact with the connector, and at least near both ends of the connector.
Since the clip is configured so that it can be tightened onto the connector side by means of a means, 1.the fastening means can always be attached to the desired position,
Especially /J at both ends! jIt is possible to eliminate the formation of blood clots and the prolapse of the container due to the generation of minute gaps due to body pressure,
It is possible to connect the containers sufficiently and reliably by using the previous type (J・1 structure).

[Brief explanation of drawings]

1 to 9 show embodiments of the present invention, FIG. 1 is an exploded perspective view of a sac-type blood pump device according to the first embodiment, FIG. 2 is a sectional view of the connector portion, Figure 3 is a perspective view showing how to attach the tying hand, Figure 4 is a sectional view of the connector to explain the situation in which blood pressure can build up and cause the cow to sag, and Figure 5 is a connector according to the second embodiment. FIG. 6 is a cross-sectional view of the connector portion according to the third embodiment; FIG. 7 is a cross-sectional view of the connector portion according to the fourth embodiment; FIG. FIG. FIG. 10 is a schematic diagram showing how the Zack type blood pump device is used. In addition, in the symbols shown in the drawings, 2---1...-----Blood chamber 3 =
-1~-Blood for 4 people 4------1111Liquid discharge pipe 12------Cannula 13------Connector 14~----Flange 15.161-Country fitting 17- --- Blood 19.20 --- Binding band 21.22 --- One recess. Agent Patent Attorney Hiroshi Aisaka 20th 3rd day 1°15 15th fly 4th day! 11 50th 60th 70th 80th 9th day 212 town 22 10th exit

Claims (1)

[Claims] 1. A first fluid conduit and a second fluid conduit led from the driven part to be pulsatilely driven through the first fluid conduit are inserted from each end of the tubular connector. In the connecting device for fluid conduits configured to be connected to each other by
A tubular clamping means for clamping the fluid conduit and the connector is in contact with the protrusion and extends to both ends of the connector while being positionally regulated by the protrusion, and at least in the vicinity of these ends. A connecting device for a fluid conduit, further comprising tightening means for tightening the clamping means against the connector.