JPS5875557A - Pulse type 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 is directed to an improved blood pump producing a pulsatile flow of sack or tube size, which can be used in blood pumps, especially artificial hearts and auxiliary artificial hearts.

Currently, roller pumps are exclusively used as blood pumps for artificial heart-lung machines and artificial kidneys.

However, it has been revealed that this 90-Labon pump is incapable of providing pulsatile flow to the blood, and that there is a period of time physiologically and in maintaining blood circulation to the ice tank blood vessels.
There is a carp that cannot be used between IFs and can only be used for 6 to 7 hours at most. In addition, in the conventional blood pump with a sac, the d part and the blood sac part, which have the blood inlet tube and the ms outlet tube, are separately awarded, and the blood sac part and the ni part are attached. It was manufactured. According to this conventional method, the blood sac portion (blood chamber) always has irregularities or defects mainly at the bonded portion. The unevenness of the surface that comes into contact with the JL liquid becomes a critical nuisance when using the M liquid. In other words, this is because blood clots are rapidly generated from these uneven portions during blood injection. 'The thrombus may grow and eventually impair the I11 function of one of the valves, which is why this type of blood pump is put into practical use as an auxiliary heart set or an artificial stone. It's a big bowl of food. As mentioned above, even if a large thrombus does not grow, some of the falsely generated thrombus components may dislodge.

There is a risk that it will become fine powder and flow into the bloodstream, causing a cerebral embolism, and it is said that prevention of this thrombus growth is essential.

The conventional sack-type blood pump shown in Fig. 1 consists of a pressure-resistant (for example, made of polycarbonate) outer case 1 and a blood chamber 2 that is shaped like a flat bag and has an arcuate shape. In the upper part of the blood chamber 2, a blood inlet pipe 3 and a blood discharge pipe 4 are formed upward and substantially parallel to each other, and a fiib is attached around the upper part. Nine.

A known valve 6 for preventing backflow of blood is installed inside the blood introduction tube 3 and the blood discharge tube 4, so that the blood introduced into the blood chamber 2 from the blood introduction tube 3 is ,
The blood is discharged through a blood discharge pipe 4.

The blood chamber 2ti is housed in a housing outer case l as shown by the stripe 11, and is held in air Vj2 by the collar 5. If the pressure of the fluid, such as air, which is pumped into the housing outer case through the boat 7 provided in the washing outer case 10 & mfi is low, the volume of the blood chamber 2 may be small, m1
It functions as a bonfu by turning the bales alternately.

The valves used in blood pumps may be any of the known heart-valve replacement valves, tissue valves made of pyrolite carbon, leaflet valves made of surface-elastic membranes such as Duramata. I can do it. As shown in these Bensha No. 2 tuna, a pyrolite carbon tire 9 is incorporated into a ring-shaped outer ring 8 made of metal, which opens and closes using a devised mechanism.

These valves are connected to the blood pump's blood te1. The inlet tube 3 and the blood outlet tube 40 are installed at the top of the tube. The valve is installed by fitting the outer ring 8, which is an outwardly concave ring, into the blood conduit, which has a convex part that fits into the concave part of the valve stem, as shown in FIG.
K is looked after. When using a blood pump in the center, the car number chamber will adjust the tension of each building depending on the positive and negative changes in external pressure.
The contractions are repeated alternately, and when this volume is retracted, a considerable amount of pressure (positive pressure or positive pressure) is applied to the valve and the conduit in which the valve is attached. Moreover, the pressure of the plow is 60 to 90 times/minute alternately between the plow and the shaft, and the force is applied to the outer ring and the conduit that holds the outer ring at the wrinkles.

Pressure 300, especially when pumping blood out of the chamber.
As you can see, it is possible to reach tiH#, but a problem that occurs when the valve is in use is that the valve stem may come off the specified set position.
This Yanghe naturally loses its function as a pulsatile blood pump,
Patients undergoing treatment may also receive a fatal blow.

Therefore, from the viewpoint of safety, the conventionally known Yuki pump is used by fitting the concave part of the outer ring into a ring-shaped convex part provided at a predetermined place where the valve stem of the valve should be fitted into the blood conduit. /jlThe pressure generated with tension not only acts on the outer ring, but also has a large effect of expanding the tube that supports the outer ring.

In particular, when the valve is installed, elastic deformation due to the pressure exerted on the blood and coexistence tube that pumps out blood is required, and it is required to prevent elastic deformation during use after installation. An example of a solution for this is that once the valve is in place in the blood conduit, a metal or polymeric material such as nylon tape with strong mechanical strength is inserted from the upper hook of the conduit. A convenient method is to tighten the outer ring from the outside along the ring by tightening it with a tool so that the outer ring does not come off during use. However, with this method, when tightening the valve stem from the outside, the tape-like supply tool is removed from the outer ring by some distance.
If the valve is misaligned or tilted even slightly with respect to the outer ring surface, an excessive force is applied to the outer ring and the valve is distorted, resulting in abnormal operation of the valve.

For example, a blood pump can be used 60 to 90 times per day during use.
The valve opens and closes at a rate of 1 minute, but if this opening and closing does not proceed smoothly, patients whose lives depend on the blood pump are at great risk.

The inventors have paid sufficient attention to these points.

As a result of repeated attempts to improve the attachment part of the valve, we created a blood pump that allows the valve to be attached, maintains stable VCl2 even when the valve is in use, and allows the valve to operate for a long time without any trouble. He was successful in sneaking around. In other words, after attaching the squares to the specified positions* of the blood inlet pipe and blood discharge pipe of the blood pump, insert the mounting part into the position of the valve shaft of the loaded valve so as to surround the valve shaft, and then insert the square into the blood pump's blood pump. One part consists of a pressure-resistant outer case that connects the trachea to the li! It relates to a blood pump formed by adding if. In the case of a sack type blood pump, the attachment portion is connected to the blood introduction tube and the blood IIj1.
They are formed so as to surround a common discharge pipe.

As the material constituting the blood cell of the present invention, polyurethane and soft vinyl chloride are preferably used. The antithrombotic property required for a blood pump is the whole blood shaking blower like the blood pump shown in the present invention.

In other words, the shape of the blood & inlet tube - from the liquid chamber to the blood discharge tK - is "forgiven" and the blood contact is smoothly shaped throughout the whole, and the rut is also typical of WM. Between the sexes - will also be extended by 11. This -
Preferably, the combined blood cell is formed by the following steps.

That is, (1) A blood chamber made of an elastic body formed in communication with a blood introduction tube and a blood discharge tube is integrally formed with the blood introduction tube and the blood discharge tube so as to have a seamless and smooth blush. (2) a step of loading the valves at predetermined positions in the blood introduction tube and the blood discharge tube; (3) attaching the attachment portions so as to cross the side portions of the valve fittings of the blood introduction tube and the predisintegration liquid discharge tube. (4) Storing a part of the blood pump in a pressure-resistant housing that is a disguised hoard for discharging and introducing the first blood, and connecting the boxwood part and the pressure-resistant housing to the air ball. It consists of the process of placing

In the conventional pulsating type blood Honda, 9i! There is a risk that the conduit may swell due to pressure and become detached from the valve stem during use, or the valve may malfunction. -1 bento and 1
J111 leaks into the contact area of the piping, and collapse plugs are often seen forming from there. Artificial stone m in the cram school where this clot occurred
+When used as an auxiliary heart-, in iia! \It also has the fatal defect of flowing in the form of small particles and plugging cerebral arteries.

The present invention has solved this problem, and has the following features: By forming a flange portion exactly at the part where the valve is attached, the valve can be attached to the container, and once attached, the valve is stable. To provide a pulsating blood pump that operates smoothly and does not cause the valve to dislodge during defecation or cause a plug to collapse at the valve stem.

Conventionally, after installing the valve, a chi-shaped object was used to press down on the valve stem and conduit from above, but in the case of the present invention,
Since there is no need to tighten it strongly, there is no risk of valve malfunction due to careless removal when stripes form, as in the case of conventional valves.

In the present invention, the thickness of the mik chamber (also known as sack mi or tube type) is preferably 02 mm to 15 cm, preferably 03 W to 15 mm, and the thickness of the umbrella is preferably Q4 m.
〜１１■ Demenyo, blood introduction tube.

The length of the discharge pipe is preferably 10 mm or more and 5 mm or less, more preferably 15 mm or more and no more than 5 arms.

The thickness of part of the blood chamber is thinner than Q2a.

When this part is compressed by external pressure, the shape of the pressure is not constant, and the flow of blood in the blood chamber varies with each beat. Blood may clot in the secondary chamber. Conversely, when it becomes thicker by 15 m, it is compressed by external pressure, j1! When doing &, the movement timing is delayed and the deformation time is prolonged, resulting in a heart-wrenching blood pumping behavior. Also, when Ia and JIIL fluids are pumped out or inhaled at a distance of 10 m or less from the blood introduction or Fi outlet, the waveform may extend to this part, which is not desirable. It is likely that the blood inlet and outlet ports will not be deformed while the blood chamber is under pressure.

This is because when this part forms a waveform every time the blood pumps out, the pulsation of the pulsatile flow is captured by the shape of this part, resulting in the desired beat III! It's because I can't get J-su.

If the discharge tube is too thick, for example, if the internal thickness exceeds 3, it will be difficult to handle.

The blood pump according to the present invention includes the tube tights 4! It can also be applied to other types of shoes, but wide-legged shoes are easier to make and more useful. In order for the sac-type blood pump to function perfectly as an artificial heart or a sleeve assistive heart, the heart rate must be 60-120 beats/m1m, and it must be exactly the same without any abnormality of KFC for at least 1 month. The blood nayanbar (4) must perform contraction and expansion operations in the following pattern. In other words, the blood pumping behavior of the sac, that is, the blood chamber, must always remain constant throughout the countless heartbeats.

And for this reason, the most important thing to do is to keep the blood chamber's pumping form-beginning school at eC-foot. When the head is turned, when this blood chamber is pressurized from the outside with air pressure, or when the inside of this J11t chamber is depressurized, the opposing inner iirms of the blood chamber are shaped inwardly from both sides. The authors found that it is extremely important to regulate the location of the point of first contact.

Regarding this point, please refer to Figure 3. 'In addition,
This 31st J (bl) connects the blood chamber to its oblate @
jiI cut along the skewer (hereinafter referred to as ``Hirodai &Uchi'')
It is an m-plane view.

The first contact point of the blood chamber mentioned above, like melting water, is the total height (in the center) of the liquid passage chamber from the &, and the width of the broad ridge, that is, the maximum middle of the blood chamber is D.
, the height direction, width, width, and vertical direction (on the center 1 of the blood flow direction V (along) in the blood introduction and discharge tube, and from the paper part of the blood chamber to Q2L and 04SL. radius Q15D, preferably QID, centered at any one point O in the height range between Q2L and Q4L, preferably between Q2L and Q4L.
It is preferable for S to exist inside the circle of α08D (the part indicated by koji in island 3WtC1).

By restricting the contact point at which the inner hook of the blood chamber first comes into contact within the above-mentioned region, the deformation behavior of the blood chamber can be kept constant over a long period of time. vice versa,
If the initial shaking point deviates from the above-mentioned area, it will cause a subtle change in blood pumping behavior, which may cause a major emergency in patients who overuse such artificial stones. There is a risk that it will affect the shadows.

As a result of intensive study on this point, the inventor has determined that
As shown in #31V, the blood chamber is made into a flat shape, and the flattening ratio in the transverse direction (the maximum diameter of the blood chamber observed under no load and the direction 4C perpendicular to this maximum width direction) It has been found that adjusting the ratio (to the carp width d (not shown)) within a predetermined range is extremely effective for regulating the initial shaking point of the stroke chamber within the range. That is, for this purpose, the flatness ratio F (D/d) of the mouth and blood chamber should be 2.0≦F≦40, preferably 2.
．． 1&F≦L5, East VC preferred fi 2.2≦F
Determine whether to set it to ≦-0 or not. When the transverse oblateness of the blood chamber falls within the above range, the deformation behavior of the blood chamber becomes very stable.9 If this oblateness is 2-0 times smaller, the blood coffin 7. There is a possibility that the deformation behavior or distorted shape may occur, and there are concerns about its practical application.

- If the oblateness of the blood chamber is larger than 40, the pressure in the housing (1) will finally become unstable when the pressure inside the housing (1) is reduced and the volume of the blood chamber increases. .

In this way, when the first point of contact in the direction of the broad ridge of the blood chamber is identified within the soil &im, the opposing inner direction first contacts at that point of contact, and then the contact surface expands around the shaking point. It continues to expand as it does.

This makes it possible to always create a constant flow of blood within the blood chamber with good reproducibility.

Therefore, li fluid is pumped out at the same speed for each heart 1'E4 through the check valve. In this way, it is essential to always create a constant blood flow within the blood chamber in order to maintain antithrombotic properties.

Blood pumps constructed using VC in this way are extremely desirable as artificial stones or auxiliary artificial hearts.
We take great pride in the fact that we were able to suppress the

The following is a detailed history of the present invention using the following examples! It-do.

First, an example of stone 1 from this project! explain. This example is an example of a sack-type blood pump in which the blood chamber is made of polyether polyurethane. 1. Add the first 1 glue of 1.
It becomes clear.

A mold as shown in FIG. 4 taJ is created. It is made of paraffin or wax and is smooth. Formed from this paraffin or wax 1.
The polyurethane polyurethane thread was dipped in a dimethylformamide treatment solution of 8 cm, then pulled out and air-dried (hereinafter referred to as the Teitsubue machine).

This operation costs 30 yen! ! Return 1. During this period, extraction with water of the polyurethane formed on the wax roof may be added during the turbulent period in order to complete the removal of the hot medium. Incidentally, the paraffin or wax w may be coated with phorisiloxane to cover the roots. By this movement, the armpit of Horiwarekun is seamlessly attached to the Jth19 in the form of rough-in or wax. In this case, JIILt#! After the thickness of L chicken bar (2) reaches the desired thickness, continue with blood interrogation II'i
The thickness of the polyurethane at the discharge pipe portion may be increased by repeating the tip step 1i a desired number of times on the discharge pipe portion. Further, in this case, the blood introduction and discharge tubes can be made rigid by using a liquid storage liquid made of polyester thread polyurethane having tuna-like properties. The preferred thickness of the blood inlet tube and the discharge tube is between L5 and C5. The molded body is then heated to a temperature above the melting point of the paraffin or wax, the melted paraffin or wax is poured out, and if desired, the molded body is washed with an excessive amount of oil, for example, petroleum ether. 4 When coating paraffin or wax molds with dimethylsiloxane, paraffin or 1
Once the wax has been oaked out, the polydimethylsiloxane film is removed, which is an easy operation.

In this way, the fourth box (relatively thick as shown in bl!
l! : Blood inlet tube (41) and blood outlet tube (3) that shoulder the rhinoceros
This soft & thin elastic JNT liquid chamber (2
) is seamlessly molded into a container. Next, the second step is to install the valve, and then the third step.
As shown in Fig. 3, the blood inlet tube and the blood outlet tube are filled with mis (51).
As shown in the figure ('+), the part is placed over the blood inlet pipe, blood i&, and discharge pipe, and is placed at the position of the valve shaft of the valve that has been previously installed, surrounding the valve shaft.

It is desirable that the brim portion and the blood pump body 1- be bonded airtightly, and any method may be used, but a perfuming agent may be used. As the adhesive, a silicone adhesive, a polycrethane adhesive, an epoxy adhesive, or the like is used. Here, the substance that makes up Iku (5) is not necessarily the blood chamber (2).

It is not necessary that the same polarity of substance as the blood inlet tube (4) and the dish liquid (3) come out. For example, it may be a polyester-based polyurethane rich in #1Il properties (or it may be made from polyvinyl chloride).

Next, do the reading BA of the fourth step. That is, as shown in Figure 1, the blood chamber is stored in the outer case (11).Next, the part and the pressure-resistant outer case (housing) are attached.In this way, the blood chamber is stored in the outer case (11). By reversing expansion and contraction according to pressure changes, it is possible to create a blood pump with seamless blood contact parts.

The pressure-resistant outer case may be made of polycarbonate, and the fluid introduction and discharge boats are preferably located at the bottom of the case. Although the hoard is installed horizontally in FIG. 1, it may be installed downward in the center of the & portion.

A first grade adhesive may be used to bond the brim (5+) and the outer case (1), or a 7 lange may be provided on the brim and fastened with screws.Pressure resistant outer The flange is pressed onto the outer case using a 7-thin joint made of polycarbonate, and these are
i You may also glue it.

The polyurethane blood pump manufactured in this example has a Fi part formed around the valve, so that the valve stem does not shift due to pressure during use, and when tightened with an external fastener. There is no local forest on the valve stem,
The operation of the valves can be performed completely.

In an experiment in which the polyurethane blood pump manufactured in this example was used as a goat left heart bypass pump,
Even after using the pump for over 100 days, the valve operated with abnormal force, and no thrombus formation was observed within the blood pump.

As a second example, a tube-type blood pump made of polyurethane will be treated.

In this example, a mold made of paraffin wax and having a flat cylindrical shape as shown in FIG. 5 is used, as shown in FIG. The center of this mud is flat, with cylindrical objects connected to both ends. Repeat the tipping process in the same manner as in wJl's *Example for the dimethylformamide bath solution or dimethylacetamide #&f& of 12-inch polyether-based polyurethane. In this example, after repeating the process 24 times to form poly-11 ether-based polyurethane (845M) on the paraffin wax spatula, the cylindrical details at both ends of the noodle, that is, the dots. The tip was further repeated 40 times from the point indicated by (X, !') to the end portion, and the film thickness at this portion was defined as Zlm.

In this example, valves are attached to the shafts tX and X.

The mounting method is the same as in the first embodiment. In this way, the tube body (Fig. 5 (a)
)) is housed in a flat and thin pressure-resistant housing shown in Figure 5 (C1) (a boat for pumping and discharging air is located in the center). Insert the 1st part made of vinyl chloride resin into the 2nd end and fix it as shown in Figure 5 (dl). In addition to adhesion, the same attachment may be done by applying 7 lunges and fastening with screws, or by using ultrasonic waves.In this way, a seamless blood pump made of tubular polyurethane can be obtained.

In this example, the tube-shaped part extends in a shape, but the blood chamber of this tube-shaped part is made into a U-shape, and the outer case is made as shown in No. 11.
The same result can be obtained even if the blood Q intake tube and the blood extraction tube are arranged in the same direction. It can also be obtained from materials other than polyurethane, for example soft vinyl chloride.

A method for manufacturing a blood pump using vinyl chloride as a third embodiment of the present invention will be explained with reference to Figure 3. Using polycyclized vinyl plastisol as a raw material, a sack as shown in Figure 93 (bl) is formed by the tip method using a known method.Same as in Example 1, load the valve at the predetermined installation position of the valve, and attach it from above. Insert the collar and position it so that it exactly surrounds the two valves.Put a polyvinyl chloride paste sol at the boundary between the blood conduit and the collar and heat it to solidify.In this way, the collar will surround the two valves exactly. It is integrally formed into an Ift shape.

This fitting part does not necessarily have to be made of the same wood as the material forming the sack. For example, it may be an epoxy resin or polyurethane or polymethyl methacrylate. Also, when polyvinyl chloride is used as the wood for the part, the saccharifier in this part is removed from the blood channel.
You can eliminate some of the plasticizer in the part. For example, when molding the front part from polyvinyl chloride stisol,
Polyvinyl chloride 1 lastisol has a relatively small amount of mobilizing agent,
For example, a plastisol consisting of polyvinyl chloride 100vIfS, dioctyl phthalate (plasticizer) 40-6011+, and calcium-zinc Ia complex 3s as a stabilizer may be used.

On the other hand, a portion of the blood chamber is a portion whose volume changes due to air movement and thereby performs pump operation, so it needs to be soft and elastic. The composition of the artistic plastisol is preferably 70 to 908% dioctyl phthalate to 100s polyvinyl chloride.

In addition, it is also possible to use a plasticizer made of negative polyvinyl chloride without adding any plasticizer, and by the method described in this book,
It is also possible to use other types of halves made of other molecular materials to which the halves and a portion of the blood chamber can fit, and these are also included in the present invention. The remaining parts of the blood pump assembly, the process of inserting the parts, and the operation process of attaching the outer case are similar to those described in the embodiment using polyurethane stock.

By such a method of the present invention, it is possible to manufacture a blood pump for an artificial heart made of soft polyvinyl chloride.

The blood horn made in this way is '&oo.

Pulsation tests were conducted using blood over a period of time, but no abnormality was found in the valve's operation. Next, when we conducted experiments using goats as a left heart bypass pump over a period of 3 months, we found that A7il- did not affect valve operation and no abnormalities were observed in thrombus formation.

[Brief explanation of the drawing]

1st- is a sack-type blood pump minute ps perspective-1 214th
Partial cross-sectional view of the installation part of the II'i valve, No. 3 is a perspective view showing the process of the SAC blood pump -1!41i! IJ (- is the fI + visual field of -1 of the wave when making the sack blood pump)
1 No. 414 (BL is a perspective view of the blood chamber that is seamlessly molded with the inlet and outlet tubes after receiving the mold.
The 5th problem is the engineering part of the tube miei pump. In the figure, 1 is a housing outer case, 2 is a blood chamber, 3 is a blood inlet pipe, 4 is a blood discharge pipe,
5 indicates a collar, and 6 indicates a valve. Patent applicant Zeon Corporation j! ! -T Concave broom 2nd 3rd sword (cL) (C) Haya 4 concave (cL)
(b) Early 5th eye (phantom (6) (C)

Claims (1)

[Scope of Claims] 1. In a pulsatile blood pump in which the blood chamber alternately undergoes compression and tension due to fluctuations in external pressure. A blood moat introduction pipe for introducing blood into the blood pump LC and a blood discharge pipe for discharging blood from the front blood distribution pump are respectively provided in the blood chamber, and the blood introduction pipe and the blood discharge pipe are respectively provided in the blood chamber. Valves for blood introduction and blood discharge are attached to the tubes, respectively, and a chamber is formed surrounding the attachment portions of these valves, and the attachment portion and a pressure-resistant outer case house the blood chamber inside. The blood pump should be stored airtight and be kept in a safe place.