JP2011019653A - Pulsation flow generation control device and adjustment method for the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To use a stroke action in the pulsation flow generation operation of a pulsation flow generation control device, and to improve pulsation operation effects by adjusting the operation into continuously repeatable maximum strokes. <P>SOLUTION: The pulsation flow generation control device Z includes a pillow tube 60 (or a blood reservation bag) made of an elastic bag and provided within an artery blood sending tube 6, a solenoid 7 (or a stroke actuation means) to press and release the pillow tube, a pressure piece 71 to press and release the pillow tube connected with the solenoid 7, a pad 610 separately provided opposite the pressure piece to sandwich and support it from behind and a distance adjusting means D for adjusting the distance between the pressure piece and the pad. The distance between the pressure piece and the pad at the start of stroke operation is adjusted so that the reciprocal movements of the pillow tube by the stroke operation-from a certain distance or more given by depressing the pillow tube by the pressure piece to the stroke start position by being pushed back by its restoration force of the pillow tube-is set up so that the stroke can be repeated in a maximum operation range. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention includes a blood circulation path that is externally connected to a patient and includes a devascularization path and a blood transmission path, and a centrifugal pump for circulating blood between the patient and an oxygenator. The present invention relates to a pulsatile flow generation control device used for a pulsatile auxiliary circulation system that generates a pulsatile flow synchronized with a patient's self-pulsation based on measurement of a pressure waveform, and a method for adjusting the device.

  Here, the pulsation type auxiliary circulation system refers to a device system including a pulsating flow generation control device.

  Currently, treatment methods for cardiac function decline vary depending on the severity of the disease. In mild cases, patient life guidance and drug therapy are performed, and advanced treatment devices such as intra-aortic balloon pumping (IABP), percutaneous cardiopulmonary assist (hereinafter referred to as PCPS), and assistive artificial heart are applied as they become severe. Has been.

  Here, the auxiliary circulation (same as PCPS) is often used as the first choice for cardiogenic shock associated with acute myocardial infarction, or cardiac function deterioration caused by severe acute myocarditis.

  For example, when assisted circulation for the purpose of life support and recovery of cardiac function is performed for patients who have declined cardiac function due to various causes, the treatment period is determined by the patient's condition and therapeutic effect, Compared to extracorporeal circulation (several hours) by an artificial cardiopulmonary apparatus generally used in cardiac surgery, it takes a long time (several days to several weeks). Therefore, blood pumping using a roller pump type heart-lung machine is not suitable because it causes blood cell destruction. For these reasons, it is common for current assisted circulation treatment to use a centrifugal pump for blood transfer. However, there is a problem that a pulsatile flow cannot be supplied to the whole body with a centrifugal pump device that generates a steady flow when the cardiac function of the patient is significantly reduced (described later). In this state, blood flow to the whole body is maintained, but protection of individual organs is often insufficient, especially in the heart, the effect of the diastolic augmentation function cannot be expected Because.

  As described above, in general, blood feeding by a centrifugal pump is a non-pulsatile flow. In contrast, the living body physiologically supplies pulsatile flow to the whole body by its own mind. The effect is a very important function not only for maintaining the circulation of the whole body but also for protecting each organ. In particular, the heart has a diastolic coronary blood flow increasing function for maintaining coronary artery blood flow by its own pulsation, so that it is particularly necessary to maintain the pulsatile flow.

  However, the current PCPS system is often used in a steady flow because it is adapted in a state where the function of the self-heartedness is reduced and the centrifugal pump cannot generate a pulsating flow.

  Furthermore, continuous perfusion with steady flow carries the risk of increasing the afterload of the recovering heart, and as a result is counterproductive in treatments aimed at restoring cardiac function. With regard to pulsatile flow, in an artificial cardiopulmonary apparatus conventionally used as an assisting means for cardiac surgery, an object generated by the rotation of a roller pump or a balloon placed in a patient's blood vessel as seen in an intra-aortic balloon pumping (IABP) apparatus Some are generated by putting gas in and out, but none of them are satisfactory due to problems with indications, invasion, and cost.

  The problems of the prior art are that, in the assisted circulation treatment performed for patients who are in a state of reduced cardiac function, they are not adapted to the patient's cardiac arrest status like the cardiopulmonary apparatus, but the self-heartedness is increased. In order to be used in motion, a pulsatile flow synchronized with the heart rhythm of the patient must be supplied.

  Here, the timing of synchronization is not driven in synchronization with the patient's electrocardiogram R wave itself as in the conventional defibrillator, but the electrocardiogram R wave is detected and the electrocardiogram T is detected within a predetermined time width. A function capable of adjusting the driving timing at the early stage of the wave is required.

  Under such circumstances, the present applicant has previously proposed a pulsatile auxiliary circulation system, a pulsatile flow generation control device, and a pulsatile flow generation control method (see Patent Document 1).

  To summarize the purpose and effect, in the assisted circulation treatment that is continuously performed for patients who have fallen into cardiac function, the diastolic coronary blood flow increase function is maintained by providing pulsatile flow to the living body, and coronary shape is maintained. It is possible to increase the blood flow of the arteries and increase the therapeutic effect aimed at restoring the cardiac function without applying an afterload to the heart.

JP 2008-264512 A

  However, although the above-described prior art can precisely match the timing of pulsation, the pulse pressure may remain small, and it cannot be said to be sufficient to expect an improvement in therapeutic effect.

  The problem to be solved by the present invention is to generate a pulsatile flow (supply to a patient) by intermittently pressing and releasing the outer surface of the artificial blood circulation circuit in synchronization with the pulsation of the patient. The aim is to ensure a sufficient pulse pressure.

  More preferably, the pressure in the duct during treatment (same as the pressure in the circuit) is mainly defined by the blood flow rate, but the therapeutic effect (including the pulsatile effect) is the patient's peripheral vascular resistance, cardiac function, arteriosclerosis Also affected by the presence or absence of. For individual patients, it is preferable to adjust these variations in treatment conditions to maximize pulsatile effects and to minimize patient invasion such as blood cell destruction.

  The present invention has been made in view of such circumstances. In the pulsatile flow generation control device used in the pulsatile auxiliary circulation system, the blood storage bag is provided in the pulsatile flow generation operation section. It is an object of the present invention to provide a pulsatile flow generation control device that can be stably provided with a sufficient amount of pulsating pressure related to the pressing / releasing operation and a method for adjusting the device.

The invention according to claim 1 is provided with a blood circulation path externally connected to a patient and comprising a devascularization path and a blood transmission path, an artificial lung and a centrifugal pump, and is based on measurement of the patient's electrocardiogram waveform and / or pressure waveform. In the pulsatile flow generation control device used for the pulsatile auxiliary circulation system for generating the pulsatile flow synchronized with the patient's self-pulsation,
A blood storage bag made of an elastic bag provided in the blood vessel channel, stroke operating means for pressing and opening the blood storage bag, and pressing the blood storage bag connected to the stroke operating means. A pressing piece to be released;
A pressing plate that is spaced apart from the pressing piece, sandwiches the blood storage bag and supports the blood storage bag from the back, and the pressing piece when the pressing piece is advanced forward by the stroke operating means, Distance adjusting means for variably adjusting the distance to the backing plate;
A pulsatile flow generation control device characterized by comprising:

  The invention according to claim 2 is the pulsatile flow generation control device according to claim 1, wherein the stroke actuating means makes the forward movement a pressing drive and the backward movement makes the drive release.

  The invention according to claim 3 is the pulsatile flow generation control device according to claim 2, wherein the stroke actuating means is a solenoid.

  In the invention according to claim 4, the distance adjusting means sandwiches the blood storage bag with the base serving as a pedestal, the stroke operating means supporting member for supporting the stroke operating means for holding the stroke operating means, A support plate supporting member that supports the support plate that supports the blood storage bag from the back surface, and at least one support member, through an attachment member having an advance / retreat adjustment member for movably disposing the distance between the support members in the separation / contact direction The pulsatile flow generation control device according to claim 1, wherein the pulsating flow generation control device is fixed to the base.

The invention according to claim 5 is provided with a blood circulation path externally connected to the patient and comprising a devascularization path and a blood transmission path, an artificial lung and a centrifugal pump, and is based on measurement of the patient's electrocardiogram waveform and / or pressure waveform. , Used for pulsatile auxiliary circulation system that generates pulsatile flow synchronized with the patient's self-pulsation,
A blood storage bag made of an elastic bag provided in the blood vessel channel;
Stroke actuating means for pushing and releasing the forward movement and releasing the backward movement for pushing and opening the blood reservoir bag, and a pressing piece connected to the stroke actuating means to press and open the blood reservoir bag An abutting plate that is spaced apart from the pressing piece, sandwiches the blood storage bag and supports the blood storage bag from the back, and the pressing piece when the pressing piece is advanced forward by the stroke operating means. A method for adjusting the distance between the pressing piece and the contact plate in a pulsating flow generation control device having a distance adjusting means for variably adjusting the distance to the contact plate,
The distance between the pressing piece and the contact plate at the time of stroke start in the pressing direction of the stroke actuating means is set so that the pressing piece pushes the blood storage bag more than a certain distance and is pushed back by the elastic restoring force of the blood storage bag and retracts to the starting position The pulsating flow generation control device adjustment method is characterized in that the reciprocating stroke operation to be returned is set to an operating range that can be repeated with a maximum stroke.

In order to solve the problem, the present invention includes a blood circulation path externally connected to a patient and comprising a devascularization path, a blood transmission path, an artificial lung, and a centrifugal pump, and measures a patient's electrocardiogram waveform and / or pressure waveform. In the pulsatile flow generation control device used for the pulsatile auxiliary circulation system that generates the pulsatile flow synchronized with the patient's self-pulsation,
It is characterized by ensuring an appropriate pulse pressure generated by fluid resistance or the like in the patient body by delivering a constant amount of pulsating blood to the patient's body every time in synchronization with the patient's electrocardiogram waveform The pulsatile flow generation control device.

Accordingly, the present invention includes a blood circulation path that is externally connected to a patient and includes a devascularization path, a blood transmission path, an artificial lung, and a centrifugal pump, and is based on measurement of the patient's electrocardiogram waveform and / or pressure waveform. In a pulsatile flow generation control device used in a pulsatile auxiliary circulation system for generating a pulsatile flow synchronized with self-pulsation, a blood storage bag made of an elastic bag provided in the blood-feeding channel, Stroke operating means for pressing and opening the blood storage bag; and a pressing piece connected to the stroke operating means for pressing and opening the blood storage bag;
A pressing plate that is spaced apart from the pressing piece, sandwiches the blood storage bag and supports the blood storage bag from the back, and the pressing piece when the pressing piece is advanced forward by the stroke operating means, It is characterized by having a distance adjusting means for variably adjusting the distance to the contact plate.

  Here, the stroke actuating means is preferably one in which the forward movement is a pressure drive and the backward movement is a drive release.

  Further, a solenoid is preferable as the stroke actuating means for releasing the drive from the backward movement.

  Further, the distance adjusting means includes a base serving as a pedestal, a stroke operating means support member for supporting the stroke operating means for holding the stroke operating means, and a blood storage bag sandwiched between and supporting the blood storage bag from the back side. The backing plate supporting member that supports the backing plate is fixed to the base via an attachment member having an advancing / retreating adjusting member for movably disposing the distance between the supporting members in the separating direction in at least one supporting member. In some cases, the configuration is made.

  On the other hand, it is a method for adjusting the distance between the pressing piece and the contact plate in the pulsating flow generation control device, wherein the distance between the pressing piece and the contact plate at the time of stroke start in the pressing direction of the stroke actuating means is the blood pressure. The reciprocating stroke operation in which the storage bag is pushed in a certain distance or more and is pushed back by the elastic restoring force of the blood storage bag to return to the starting position is set to an operating range that can be repeated with the maximum stroke. Is.

  Hereinafter, definitions and technical significance related to the invention-specific matters will be described.

  A blood storage bag made of an elastic bag body is dented by a pressing force from the outside through a part of the conduit, and elastically deforms to return to its original shape when the pressing force is released. A hollow body to be exhibited (optimally a pillow tube described later).

  Elasticity means elasticity that can be repeated for a long period of time when the pressure caused by the stroke actuating means is depressed by a certain distance and is depressed, and when the pressure disappears, the original shape is restored by being pressed by itself. Say.

  With respect to the present invention, if the elasticity is too weak, it does not return, and the blood sent from the centrifugal pump swells by accumulating in the storage bag. Since the position where the pressing piece hits the bag is different and cannot enter into the same distance, the amount of liquid feeding is not constant.

  On the other hand, if the elasticity is too strong, it expands rapidly and the inside becomes negative pressure, and blood cells are easily destroyed by cavitation.

  For this reason, since the pillow tube made of soft vinyl chloride is a bag body, unlike the tube, the bag is recessed by the pressing operation by the stroke operation means → a large amount of blood can be delivered → the pressure of the delivery line to the patient at the time of delivery becomes high It can respond to the request.

  The stroke actuating means refers to instrumental means for reciprocating the plunger. The stroke operation is a translational movement such as a piston.

  Regarding the device configuration of the present invention, it is preferably a solenoid (same as an electromagnetic valve), but the rotary motion may be converted into a translational motion by a cam or a link mechanism.

  With regard to the adjustment method of the present invention, with regard to the pressing force, the pressing speed and the stroke distance when the stroke operating means moves forward, if the stroke pressing force is small, the pressure of the blood storage bag cannot be overcome and the bag cannot be recessed, and the stroke distance If the storage bag is not large, the push-in length when pushing in the storage bag cannot be taken, and since the bag dent is insufficient, a sufficient delivery amount cannot be secured, and the pressure at the time of delivery does not increase. Will be set. The stroke distance according to the present invention is preferably several mm to several cm.

  In addition, if the reverse speed is too fast, negative pressure (or rapid pressure reduction) may occur in the blood storage bag, which may induce blood cell destruction. It is preferable to leave the means (solenoid) to be pushed back by the elastic restoring force of the bag body (blood storage bag) with the drive released.

  Accordingly, it is preferable that the stroke actuating means is configured such that the forward movement is a pressure drive and the backward movement is a drive release.

  The stroke motion is performed in synchronization with the patient's self-beat based on measurement of the patient's electrocardiogram waveform and / or pressure waveform.

  In the operation of the stroke actuating means, when the forward movement is the pressing drive and the reverse movement is released, the operation is performed with the driving force inherent in the stroke actuating means in the operation of the stroke actuating means, and the backward movement is the active driving. It means not to let you.

  For example, in the solenoid described later, the forward movement refers to the basic function of the push-type valve operation by the suction action of the solenoid, that is, the stroke operation by the device drive (switch-on) for pressing the blood storage bag, The backward movement refers to a state in which the stroke return operation is not actively performed, that is, the solenoid is released (switched off).

  Further, a solenoid is preferable as the stroke actuating means for releasing the drive from the backward movement. A solenoid is an actuator in which a movable iron core (same as a plunger) is driven straight in a coil by electromagnetic force.

  As the stroke actuating means for canceling the reverse movement, a push type solenoid having a latch mechanism (operation holding function incorporating a permanent magnet) can be used as the solenoid, for example. In this case, the blood storage bag is recessed by pressing drive, and the elastic restoring force (including the internal pressure of the pipeline) of the blood storage bag is left by releasing the drive, overcoming the latching and the plunger (the valve body with the base end fixed) It is set to push back. Therefore, in the stroke operation of the reverse stroke, while the latch is effective, the plunger moves backward while the operating end of the valve body (specifically, a pressing piece to be described later) is in contact with the operated surface of the blood storage bag. (Push back). This is to avoid the risk of blood cell destruction described above.

  The pressing piece is an action piece provided at the distal end of the valve body whose base end is fixed to the plunger, and is used for applying a surface pressure to the blood storage bag to be recessed. In order to effectively apply the pressing force from the stroke actuating means to the blood storage bag without damaging the blood storage bag, it is preferable that the pressing is flat and has a certain size. It is preferable that the pressing piece is pressed against the central portion of the blood storage bag in order to effectively dent the storage bag.

  The contact plate is a plate (plate-like body) that supports the pipe line (blood storage bag) from behind the surface to be acted on by the pressing piece, is movably installed in the pressing direction, and the separation distance from the pressing piece is variable. To be adjusted.

  The maximum forward means the forward critical point (top dead) of the stroke operation.

  The distance adjusting means is an instrumental means for variably adjusting the separation distance between the pressing piece and the contact plate.

  The base means a pedestal on which an object (supporting member in the present invention) is placed or received.

  The stroke actuating means support member is a member that is placed on a base (pedestal) and holds the stroke actuating means.

  The backing plate support member is a member that is placed on a base (pedestal) and holds the backing plate at an appropriate distance.

  The mounting member having an advance / retreat adjustment member for movably disposing the distance between the support members in the separation / contact direction is a guide member that fixes and supports the advance / retreat adjustment member (for example, a screw element).

  The time of starting the stroke in the pressing direction means the time (return critical point) at which the stroke operation of the plunger (including the valve body and the pressing piece) becomes bottom dead.

  Retraction to the stroke start position in the pressing direction of the stroke actuating means pushed back by the blood storage bag means that the pressing piece returns to the start (initial) position of the stroke operation in the forward stroke (returned back) in the stroke operation of the backward stroke. That is.

  The reciprocating stroke operation in which the pressing piece pushes the blood storage bag more than a certain distance and is pushed back by the elastic restoring force of the blood storage bag to return to the starting position is set to an operating range that can be repeated with the maximum stroke. The distance between the pressing piece and the contact plate is adjusted (set) so that the maximum stroke can be secured in the repeated operation (continuous operation) of the stroke operating means.

  If the distance between the pressing piece and the backing plate is not appropriate and is too short, the original stroke operation means loses the pillow tube repulsive force (including the pressure in the pipe line) and cannot be pushed completely (stroke operation) The situation that stops in the middle occurs. On the other hand, when the distance between the pressing piece and the contact plate is too long, the repulsive force (including the pressure in the pipe line) of the pillow tube is insufficient, and the stroke does not return to the full stroke length of the stroke operating means 7. A situation occurs that stops in the middle of the operation (return stroke).

  That is, if the set distance is too short or too long, the stroke operation is hindered and the maximum stroke cannot be secured. The maximum stroke here refers to the stroke distance originally possessed by the stroke operating means.

  In such a case, the pressure (dent) / opening (elastic restoration) of the blood storage bag is not sufficiently secured, so as a pulsatile flow generation operation, the delivery amount is small → the pressure does not increase → the pulse pressure remains small Problems such as staying will occur. Therefore, the distance adjustment (setting) in the present invention is an important and indispensable element.

  According to the present invention, the maximum stroke in the stroke operation can be secured, the stroke length can be effectively utilized, and the pressing operation against the blood storage bag can be performed efficiently and sufficiently. The value of the pulse pressure related to the operation can be secured stably high. For this reason, the pulse pressure (physiological pulse pressure) required for the pulsation of the living body can be secured by combining the stroke actuating means and the blood storage bag and optimizing the distance by the distance adjusting means. Therefore, the assisting circulatory effect can be augmented by providing a more physiologically effective and safe pulsatile flow even to a patient who has suffered severe cardiac function deterioration.

  Specifically, a pulsatile flow generation operation section with a blood storage bag (optimally a pillow tube) is provided in the blood vessel channel, and stroke operation means (optimally a solenoid having a latch mechanism described later) is provided. It drives to push or release the pillow tube, and can provide a physiological pulsatile flow in the assisted circulation treatment performed for a patient who has fallen into a state of reduced cardiac function. Moreover, it is possible to avoid or prevent damage to the inner wall of the duct and blood cell damage due to the pulsatile flow generation operation.

  As a result, the coronary blood flow increasing function can be maintained and the blood flow of the coronary artery can be increased, so that selective assisted circulation in the diastole is possible. Since the pressurizing effect of P + ΔP can be expected, an increase in coronary blood flow and recovery of cardiac function can be expected by its secondary action. For this reason, in the assisted circulation therapy performed continuously, it can be anticipated that the therapeutic effect aiming at recovery of cardiac function will be increased without giving an afterload to the heart.

  In particular, in order to press and release the pillow tube, it is possible to secure the maximum stroke in stroke operation by adjusting the distance between the pressing piece and the backing plate, maximizing the pulsation effect commensurate with the treatment conditions It can be demonstrated.

  In addition, it is possible to construct a pipeline fixing base with the distance adjustment means as the main part, and it is possible to prevent the pipeline (including the pillow tube) from rotating or swinging due to repetitive operation (continuous operation), and stable operation of the equipment. To ensure.

It is a structure outline explanatory drawing of the pulsating flow generation control device (example device) of the present invention. It is (a) top view explanatory drawing of the Example apparatus which shows a distance adjustment means, and (b) AA line partial missing sectional view explanatory drawing. It is explanatory drawing which shows the adjustment method of distance. It is drawing substitute photograph which shows an example of the form of a pillow tube, (a) Front view external view and (b) Plan view external view. It is a drawing substitute photograph which shows the monitoring screen of the blood circulation state which shows the experimental result in an animal experiment (Example 2), (a) Pressure (blood pressure) waveform when not using distance adjustment means, and (b) Pressure at the time of distance adjustment (Blood pressure) waveform.

  The form for implementing this invention WHEREIN: In the pulsating flow generation | occurrence | production control apparatus of the said structure, a stroke operation means is a solenoid, and shall make a forward drive a press drive and make a reverse drive release.

  Further, the distance adjusting means includes a base serving as a pedestal, a stroke actuating means support member for holding the stroke actuating means, and a pad that sandwiches the blood reservoir bag and supports the blood reservoir bag from the back. The plate support member is fixed to the base via an attachment member having an advance / retreat adjustment member for movably disposing the distance between the support members in the separation direction in at least one support member.

  Then, the distance between the pressing piece and the contact plate at the time of starting the stroke in the pressing direction of the stroke operating means is adjusted (set) so that the stroke operation in the repetitive operation (continuous operation) can secure the maximum stroke.

  A pulsating flow generation control device (embodiment device) of the present invention will be described below with reference to the accompanying drawings.

  FIG. 1 is a schematic diagram for explaining the configuration of the embodiment apparatus.

  FIGS. 2A and 2B are an explanatory view of the apparatus of the embodiment showing the distance adjusting means, and FIG.

  As shown in FIG. 1, the embodiment device Z is provided with a blood storage bag 60 (hereinafter referred to as a pillow tube) made of an elastic bag in the path of the blood vessel transmission path (hereinafter referred to as a pulsatile flow generating operation section). At the same time, a stroke actuating means 7 that operates as a valve to press and release the pillow tube 60 and a pressing piece 71 that is connected to the stroke actuating means 7 and applies a surface pressure to the pillow tube 60 are provided. The stroke actuating means 7 is driven and controlled by a control output from a pulsating flow generation control means 11 (control device 11 in the figure).

  As the suitable stroke actuating means 7, a commercially available solenoid [for example, model EL-1005 manufactured by Takasago Electric Co., Ltd.] can be used. This solenoid is a solenoid having a push-type latch mechanism. A solenoid having this type of latch mechanism (operation holding function incorporating a permanent magnet) is used because the elastic restoring force (including the pressure in the pipe line) of the pillow tube 60 overcomes the latching in the return stroke, and the plunger 73 So that the valve body 72 with its proximal end fixed is pushed back, that is, the pressing piece 71 remains in contact with the pillow tube 60 while the latch is effective, and the plunger 73 is left in contact with the elastic restoring force of the pillow tube 60. This is because it is desired to retract the valve body 72 (push it back). This is to avoid the risk of blood cell destruction being induced by rapid decompression in the duct (pillow tube 60).

  The pressing piece 71 used was a rubber-made cylindrical one having a thickness of 13.0 mm and a diameter of 33.0 mm. In addition, when the pressing piece 71 is installed at a distance from the pressing piece 71 and has a support plate 610 that sandwiches the pillow tube 60 and supports the pillow tube 60 from the back surface, A distance adjusting means D for variably adjusting the distance d between the pressing piece 71 and the contact plate 610 is provided.

  Here, as shown in FIG. 2, the distance adjusting means D includes a base 800 serving as a pedestal, a stroke actuating means support member 700 for holding the stroke actuating means 7, and a pillow tube 60. And at least one support member (600/700) for moving the distance between the support members in a detachable direction. It is fixed to the base 800 via an attachment member 620 having an adjustment member 621. The distance adjusting means D may be constructed as (main part) of the pipeline fixing base DX.

  The distance d can be moved back to the stroke start position in the pressing direction of the stroke operating means 7 by the pressing piece 71 being pushed back by the pillow tube 60, and the stroke operation in the pressing direction of the stroke operating means 7 can be repeated with the maximum stroke. The operating range is set.

  FIG. 3 is an explanatory diagram related to the distance adjustment method.

  As shown in the figure, the distance d between the pressing piece 71 and the contact plate 610 is set (including the operation procedure) so as to satisfy the following condition.

  First, when the distance between the stroke actuating means 7 adjusted and fixed by the distance adjusting means D and the contact plate is temporarily fixed, the foremost push when the stroke actuating means 7 performs a stroke operation to the full stroke length which is the device specification thereafter. There is a position a (top dead) and a last retracted position b (bottom dead) when pushed back by an external force (repulsive force of the pillow tube 60). Of course, the positions of the pressing pieces 71 connected thereto are A, B. Therefore, the distance between the pressing piece 71 and the contact plate 610 is d (A) and d (B) shown in the figure.

  Here, when the distance between the pressing piece 71 temporarily fixed and the contact plate 610 is not appropriate and is too short, the original stroke actuating means 7 loses the repulsive force (including the pressure in the pipe line) of the pillow tube 60. Therefore, there is a situation where it is not pushed completely and stops in the middle of the stroke operation (forward stroke).

Now, let C be the position of the pressing piece 71 at the forward critical point when the stroke operation to push the full stroke length cannot be performed, and let d (C) be the distance.

  On the other hand, when the distance between the pressing piece 71 and the contact plate 610 is too long, the repulsive force (including the pressure in the pipe line) of the pillow tube 60 is insufficient, and the stroke operating means 7 does not return to the full stroke length, A situation occurs in which the operation stops in the middle of the stroke operation (return stroke).

  Now, let E be the position of the pressing piece at the critical point for backward movement when the stroke operation for returning the full stroke length cannot be performed, and let d (E) be the distance.

Then, the upper and lower limits of the setting range of the distance d need to satisfy the following (1) and (2).
(1) d (top dead): d (A) ≧ d (C)
(2) d (bottom dead): d (B) ≦ d (E)
Naturally, the setting range (condition) of the distance d for securing the maximum stroke is:
It is d (A) <= d <= d (E).

  The outline of the device operation will be described below.

  When the auxiliary circulation is performed, the centrifugal pump 3 is rotated by a magnetic force transmission method. Due to the rotation, negative pressure is generated on the side of the devascularization path 2 to guide the venous blood of the patient H. The venous blood is drawn to the centrifugal pump 3 where it is converted to positive pressure and sent to the artificial lung 5. The blood oxygenated by the artificial lung 5 becomes arterial blood and is sent to the artery of the patient H through the blood vessel 6 and 8.

  Stroke actuating means 7 (hereinafter referred to as solenoid) is attached to the delivery line 6 on the delivery side of the artificial lung 5 through a pillow tube 60 to form a pulsatile flow generating operation section. By continuously applying mechanical press and release to the pillow tube 60, blood supply is periodically and rhythmically interrupted to generate a physiological pulsatile flow, which is supplied to the patient H.

  The solenoid 7 is actuated and controlled (driven) by a control output from the pulsatile flow generation control means 11 (control device 11 in the figure), and starts and stops according to the pulse rate of the patient H.

  Here, an R wave is detected (delayed detection) from the electrocardiogram waveform measuring device 13 and inputted as a starting point, and is delayed at the end of the T wave indicating the diastole in the patient's self-pulsation (specifically, delayed at the initial generation of the T wave) The drive start time (predetermined time width from delay detection to delay release) can be adjusted so that the solenoid valve is pressed and driven.

  Furthermore, the embodiment apparatus Z is equipped with the distance adjusting means D (hereinafter, the pipe fixing base DX) as described above [see FIG. 2].

  The purpose, function, and effect of this pipeline fixing base DX are as follows. First, the pressing piece 71 is pushed back by the pillow tube 60 and can be moved back to the stroke starting position in the pressing direction of the solenoid 7, and the stroke operation in the pressing direction of the solenoid 7 is performed. Is to adjust the distance d related to the pulsating flow generation operation so that the maximum stroke operation range is set. Second, the pipe connection end of the pillow tube 60 is restrained by the pipe fixing member 611. Thus, the rotation or swing of the pipe line 8 (6) is prevented or suppressed during operation of the apparatus.

  In addition, a bypass pipe (not shown) branched from the pipe 8 (6) at both ends of the pillow tube 60 is provided, and the bypass pipe (not shown) that can be shut off in a normal time and can be opened in an emergency. It is preferable to attach.

  For reference, the selection criteria for the pillow tube 60 are introduced.

  An artificial cardiopulmonary circuit used as an auxiliary means for cardiac surgery is determined by patient weight, but there is no unified standard, and it is made to order for each medical facility.

Selection criteria relating to the capacity of the pillow tube in the present invention are as follows.
(I) Patient weight less than 30kg (S circuit) Pillow capacity 25ml
(B) Patient weight 30-60kg (M circuit) Pillow capacity 35ml
(C) Patient weight 30kg or more (L circuit) Pillow capacity 45ml

  FIG. 4 is a drawing-substituting photograph showing an example of the form of the above-mentioned pillow tube (M). The external measurement dimensions are (a) 90 mm in the length direction shown in the front view and 45 mm in the width direction shown in the front view, and (b) 25 mm in the thickness direction shown in the plan view.

  Moreover, the clinical effect regarding this invention apparatus and its adjustment method was verified by the animal experiment.

  [Experimental Purpose] The effect of the adjustment method in the pulsatile flow generation control device of the present invention configuration on the pulsation effect will be verified.

  Here, a pulsatile flow generation control device was incorporated in a standard auxiliary circulation circuit, and blood was removed from the subject's right atrium and blood was sent to the left common carotid artery. [Refer to Figure 1 for circuit configuration]

  [Experiment method] Using a white rabbit (Japanese white species; male; 2.5-3.0 kg) as a subject, incorporating the pulsatile flow generation control device of the present invention into a standard auxiliary circulation circuit and adjusting the distance ( Hereinafter, during distance adjustment.), Blood was removed from the subject's right atrium, and blood was sent to the left common carotid artery to monitor the blood circulation state.

  On the other hand, except that the distance adjusting means was not incorporated into the pulsating flow generation control device, the other operations were performed in the same manner as in Example 2 (hereinafter, when the distance adjusting means was not used) as a comparative control.

  [Experimental Results and Discussion] FIG. 5 is a drawing-substituting photograph showing a blood circulation monitoring screen related to the pulsation effect. (A) is a pressure waveform when the distance adjusting means is not used, and (b) is a pressure waveform when the distance is adjusted. Annotations are added in the figure.

  As understood from the respective pressure waveforms and annotations, when the distance adjustment means is not used (a), the stroke adjustment is not possible, so the timing at which self-cardiac pressure and auxiliary pressure appear and the size of the auxiliary pressure (which is) However, at the time of distance adjustment (b), the diastolic assist pressure was accurately added, and the diastolic coronary blood flow augmentation effect was observed and the pulse pressure was secured. I can see that

  Regarding the experimental results, it is suggested that the electrocardiogram synchronization is possible and the increase in diastolic pressure can be expected, which is useful for improving cardiac function.

  The present invention is innovative as an instrumental means for supplying a physiological pulsatile flow synchronized with an electrocardiogram in the assisted circulation therapy performed for cardiac function deterioration.

  In addition, even during normal cardiac surgery, it is possible to supply pulsatile flow that was conventionally possible in the state of cardiac arrest through the circulation of the extracorporeal circulation.

  Furthermore, it is possible to supply physiological pulsatile flow for myocardial protection currently performed in steady flow and selective cerebral perfusion performed in the treatment of thoracic aortic aneurysms, It is also useful from the viewpoint of myocardial protection and brain protection.

2 Venous blood feeding blood vessels [devascularization]
3 Centrifugal pump 5 Artificial lung (oxygenator)
6 Elastic blood vessel
60 Pillow tube (blood storage bag)
600 Contact plate support member
610
611 Pipe fixing member
620 Mounting member
621 Advancement / retraction adjustment member 7 Solenoid [Stroke actuating means]
71 Pressing piece
72 Disc
73 Plunger
74 Permanent magnet
700 Stroke actuating means support member 8 Arterial blood-feeding blood vessel
800 base
11 Control device (Pulsating flow generation control means)
13 Patient ECG [Electrocardiogram waveform measuring device]

D Distance adjustment means
DX pipeline fixing base d distance H patient Z pulsatile flow generation control device [Example device]

Claims (5)

Externally connected to the patient, equipped with a blood circulation path consisting of a devascularization and delivery line, artificial lung and centrifugal pump, synchronized with the patient's self-beat based on measurement of the patient's electrocardiogram and / or pressure waveform In the pulsatile flow generation control device used for the pulsating auxiliary circulation system that generates the pulsatile flow,
A blood storage bag made of an elastic bag provided in the blood vessel channel, stroke operating means for pressing and opening the blood storage bag, and pressing the blood storage bag connected to the stroke operating means. A pressing piece to be released;
A pressing plate that is spaced apart from the pressing piece, sandwiches the blood storage bag and supports the blood storage bag from the back, and the pressing piece when the pressing piece is advanced forward by the stroke operating means, Distance adjusting means for variably adjusting the distance to the backing plate;
A pulsatile flow generation control device characterized by comprising:   2. A pulsatile flow generation control device according to claim 1, wherein the stroke actuating means sets the forward movement as the pressing drive and the backward movement as the drive release.   3. The pulsatile flow generation control device according to claim 2, wherein the stroke operating means is a solenoid.   The distance adjusting means includes a base serving as a pedestal, a stroke operating means support member that supports the stroke operating means for holding the stroke operating means, and a pad that sandwiches the blood storage bag and supports the blood storage bag from the back. A support plate supporting member for supporting the plate is fixed to the base via an attachment member having an advance / retreat adjusting member for movably disposing a distance between the support members in the separation / contact direction in at least one support member. The pulsatile flow generation control device according to claim 1, wherein the pulsating flow generation control device is provided. Externally connected to the patient, equipped with a blood circulation path consisting of a devascularization and delivery line, artificial lung and centrifugal pump, synchronized with the patient's self-beat based on measurement of the patient's electrocardiogram and / or pressure waveform Used for pulsatile auxiliary circulation system to generate pulsatile flow,
A blood storage bag made of an elastic bag provided in the blood vessel channel;
Stroke actuating means for pressing and releasing the forward movement to release and driving the reverse movement to press and open the blood reservoir bag, and a pressing piece connected to the stroke actuating means to press and open the blood reservoir bag An abutting plate that is spaced apart from the pressing piece, sandwiches the blood storage bag and supports the blood storage bag from the back, and the pressing piece when the pressing piece is advanced forward by the stroke actuating means. A method for adjusting the distance between the pressing piece and the contact plate in a pulsating flow generation control device having a distance adjusting means for variably adjusting the distance to the contact plate,
The distance between the pressing piece and the contact plate at the time of stroke start in the pressing direction of the stroke actuating means is set so that the pressing piece pushes the blood storage bag more than a certain distance and is pushed back by the elastic restoring force of the blood storage bag and retracts to the starting position. A method for adjusting a pulsating flow generation control device, wherein the reciprocating stroke operation to be returned is set within an operating range that can be repeated with a maximum stroke.