JPS587257A - Blood pump - 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 The present invention relates to a blood pump device for an artificial heart, and more particularly to an improved blood pump driven by fluid pressure. The development of an artificial heart to temporarily and auxiliarily replace the function of the heart after death is underway.

Research on artificial hearts driven by gas pressure has been carried out in Japan ahead of the rest of the world, and long-term survival records using goats have yielded good results, but in reality
The path to clinical application for patients is still open, but particular problems are the problem of blood orange production inside the artificial heart and the problem of valve OMR.

The present invention relates to the top of the valve Ota in a blood pump.
The present invention will be explained below based on the drawings.

FIG. 1 shows the basic form of a knack-type blood pump and blood chamber O, which is an example of a blood pump.

The sac-lid blood moat pump is composed of a pressure-resistant (for example, polycarbonate J1) housing outer case 1, and nine blood champers 2 each having a flat bag shape with an arcuate bottom surface. At the upper part of the 0m1i chamber 20, a blood inlet pipe 3 and a blood discharge pipe 4 are formed upward and substantially parallel to each other, and a flange 5 is attached to the upper circumference of 1 mK. In addition, a known O valve 6 is provided inside the blood introduction tube 3 and the blood discharge tube 4 to prevent backflow of blood O, so that blood can be introduced from the blood introduction tube 3 into the chamber/bar 2. Blood is discharged from a blood drain tube 4.

The blood chamber 2 is housed in a housing outer case 10 as shown in FIG. a11, and is held in air by seven lunges 5. The blood chamber 20 volume is alternately contracted and expanded due to changes in the pressure of fluid, for example air, which is forced into the housing outer case through a pipe 7 provided at the bottom 1iIII of the housing outer case 10. It functions as a pump.

The present invention relates to an improvement in the loading part of the valve of such a blood pump, and S* of the valve is a known heart valve replacement amount.
Any leaflet valve made of an elastic membrane such as Duramata O can be used. As shown in Fig. 2, these O-valves include, for example, a metal OIJ song-shaped front wheel 8 and a pyrolite carbon disc! are built in, and each one is designed to open and close using a towing mechanism.

These O valves are inserted 4 m into appropriate positions of the blood pump O blood inlet pipe 3 and blood discharge pipe 4. For example, as shown in FIG. 2, if the front wheel 8 is formed outwardly in a concave shape and is made of a good metal ring, the valve is attached by forming a convex portion that corresponds to the concave portion of the front wheel on the blood conduit to be attached. It is attached so that it fits into this.

When actually using a blood pump, the blood chamber/bar alternately expands and contracts in response to changes in external pressure. Considerable pressure (positive or negative pressure) must be applied to the attached conduit. Moreover, the O pressure is 60 ~ yang and yin alternately! This occurs at a frequency of 0 per minute, and each time the force is applied to the front wheel and the conduit that holds the front wheel. As a problem, the front wheel may come off the predetermined 0-set position, and in this case, the function as a pulsating pump will be lost, and the patient being treated will receive a fatal blow. In conventionally known blood pumps, the front wheel of the valve is provided at a predetermined location where the blood conduit should be fitted, and the concave portion of the front wheel is fitted into the ring-shaped protrusion 11. The pressure generated does not only act on the front wheel, but also has a large effect on expanding the tube into which the front wheel is fitted, and the pressure exerted on the blood discharge tube that pumps out blood is particularly large.As a known material for blood pumps, Polyurethane or soft polyvinyl chloride is used, but since these are originally elastic bodies, they deform and crack under pressure.

However, the blood inlet pipe and the blood discharge pipe are required to have moderate elastic deformation when the valve is installed, and are required to undergo elastic deformation after being installed and used. This friend O
As a solution, the fl-, t is attached to the predetermined O position of the blood conduit, and then a metal or polymer material such as a nylon O tape-like O fastener with strong mechanical strength is inserted from the top of the conduit. A convenient method is used to tighten the front wheel from the outside along the ring so that the front wheel does not come off when in use. However, with this method, when tightening the front wheel from the outside, if the tape-like fittings are slightly displaced from the front wheel, or even slightly tilted with respect to the front wheel surface, local forces will be applied to the front wheel, causing distortion. As a result, an abnormality occurs in the operation of this friend valve. For example, blood pumps open and close their valves at a rate of 60 to 90 times per minute during use, but if this opening and closing does not occur smoothly, it can be extremely dangerous for patients whose lives depend on the blood pump. You will be exposed.

The inventors of the present invention have conducted various studies on the material and thickness of the CIILK loading portion, and have found a material that allows the valve to be attached and that allows the valve to be held stably even during use. Ben O! We have found that if certain conditions are met regarding the thickness range of the filling part, the valve can be installed stably and safely, and there will be no trouble during use. First, the material is polyurethane and a specified amount of plasticizer is used. It is to use flexible polyvinyl chloride containing.

Both polyether polyurethane and polyester polyurethane are used as the polyurethane used in carrying out the present invention, and are produced by reacting an inquanate group with a hydrogen atom of a hydroxyl group to form a urethane feed. Any incyanate conventionally used in the production of polyurethanes can be used. To obtain polyurethanes, isocyanates are reacted with polyols containing two or more 00H groups; conventional polyols are loaded with polyhydroxy polyesters and polyethers. This polyester is produced by esterification of glycols such as ethylene glycol, diethylene glycol or polyhydric alcohols such as trimethylolglucone, glycol, sorbitol, etc. with polyhydric carboxylic acids such as adipic acid, succinic acid, etc. It will be done.

Suitable polyethers are obtained, for example, by polymerization of alkylene oxides or by condensation of alkylene oxides with known polyhydric alcohols. Examples of alkylene oxides include ethylene oxide, t2-propylene oxide, t2-butylene oxide and t5-propylene oxide. Examples of polyhydric alcohols include propylene glycol, glycerol, trimethylol, trimethylolpropane, tz6-hequinanetriol, pentaerythritol, and the like. Furthermore, the degree of polymerization of polyvinyl chloride used in carrying out the present invention is 500 to 2.
0001i plasticizer is preferred.The amount of plasticizer is important and should be 40 to 120 parts by weight per 100 parts by weight of polyvinyl chloride.
Parts by weight, preferably 50 to 80 parts by weight. If it is less than 40 parts by weight, it lacks softness, and if it is more than 120 parts by weight, it becomes too soft, resulting in poor or inappropriate valve loading, valve operating conditions, etc.0 Plasticizers used include DOP (dioctyl fuclay), Do (dioctyl adipate)
is preferably used from the viewpoint of birch-free Om.

The present invention also provides that the blood discharge pipe has a wall thickness of at least 10 cm in the length direction of the valve from the attachment part of the valve to 5.0 cm or more, preferably 5.0 cm or more and 40 cm or less, The blood pump is more preferably t8- or more and 55- or less, most preferably 2.0- or more and 42- or less.

If the wall thickness of the blood discharge pipe is less than 15+W, there is a danger that the pipe will swell due to pressure and the front wheel will come off, as described in detail above, and the valve will malfunction, and even if the front wheel does not come off, the pump will not work properly. When the front wheel is attached during use, the deformation of the front wheel is large, and blood flows into the contact area between the front wheel and the tube, often resulting in the formation of a thrombus.When using the heart as an artificial heart or auxiliary heart with this thrombus formed, It also has the fatal defect of flowing as small particles into the bloodstream and embolizing brain cells.

Furthermore, if the thickness exceeds the SO thickness, the conduit becomes stiff, making it difficult to attach the valve and causing great inconvenience in use.

The reason why these wall thicknesses should be at least 10 mm thicker than that of the valve mounting part is because if the inner thickness is 10 mm or less, the effect of the inner thickness will be lost. The wall thickness of the tube is not limited to the blood discharge tube 4, but also applies to the blood introduction tube 3 as well.

As explained above, the present invention allows the valve to be easily installed by adjusting the material and thickness of the conduit to which the valve is installed within a predetermined range, and once the valve is crushed, it operates stably and during use. It has the characteristic that it does not cause the valve to dislodge and cause thrombus to form in the anterior annular region.

In addition, after installing the valve, you may also use tape-like material to hold down the front wheel and conduit from above, just to be sure.

In the case of the present invention, since there is no need to tighten strongly, the valve does not malfunction due to clumsiness during tightening as in the conventional case. The present invention will be explained in more detail with reference to Examples below.0 Examples 1 to 13 Using the Nak go blood pump shown in Figure 1, change the blood inlet tube and blood outlet tube OWi, install the fluid inlet tube of the outer case separately, then connect it to the pneumatic drive Sat and use fresh salt water to connect the valve. A friend to check the sound of the operating status. Follow this result! ! In the table below, polyvinyl chloride was Zeon Paste manufactured by Nippon Zeon Co., Ltd., and polyurethane was Nisten 5740 (Dattritsute J1) and Baraprene P50.
0 (manufactured by Elastra) in 1990.
Example 114 Conducted on 10 g/weight of vinyl chloride The sac-type artificial hearts of Examples 5 to 15 were used as left heart bypass pumps in goats for one month. At this point, the fluid drainage tube was connected to the descending tube using a cannula, while the blood inlet tube was connected to the left atrium using a cannula.

The goat survived for one month with the O pump, but after one month, when we examined the O blood blood formation IIvr, we found that it was a real case 6゜7, Lu,
? , 10, 12.13 did not have any formation of Imperial Role in the valve part. On the other hand, in Example 3.4.5.11, blood #kO was observed near the front wheel, and in Example 5. , 11 is in good condition with occasional valve malfunction.

4.li! Figure 1 is an exploded perspective view of the Sac Taki blood pump.
2111 is a partial vertical sectional view of a blood discharge pipe equipped with a blood discharge valve.

In the symbols, 1 is a housing outer case, 2 is a blood chamber/bar, 5 is a blood inlet pipe, 4 is a blood discharge pipe, 5 is a 7 lange, 6 is a valve, 7 is a fluid delivery pipe, 8 is a front wheel, and 9 is a blood discharge pipe. Each disc is shown.

Patent applicant: Nippon Zeon Co., Ltd.

Claims (1)

[Claims] A blood chamber/bar is formed in communication with a blood introduction tube and a blood discharge tube, each of which has a built-in valve for introduction and a valve for blood discharge. Pump K>, of the blood inlet pipe and the blood discharge pipe with a built-in valve, at least the blood discharge pipe is coated with 40 to 120 parts by weight of plasticizer per 100 parts of polyurethane or polyvinyl chloride. A blood pump made of polyvinyl chloride containing polyvinyl chloride, and having a wall thickness of at least 10 m in the length direction of the front pipe (from the valve mounting part) to tS. .