JPH0362409B2 - - Google Patents

Description

[Detailed Description of the Invention] [Industrial Application Field] The present invention relates to a ventricular shunt device for intracranial compliance measurement, and particularly to an intracranial compliance measurement device capable of measuring intracranial compliance of patients with hydrocephalus, etc. Concerning a dual-purpose ventricular shunt device. The ventricular shunt in this device is
It functions as a ventricle-peritoneal shunt or a ventricle-atrial shunt that is surgically implanted into the body of a patient suffering from hydrocephalus or the like.

[Conventional technology]

Generally, in neurosurgical diseases accompanied by increased intracranial pressure, accurate measurement of intracranial pressure is necessary to elucidate the pathological picture.

In particular, as an intracranial system parameter, intracranial pressure P
Various proposals have been made to measure the intracranial compliance C, which indicates the displacement of the intracranial volume V below.

That is, in the intracranial system model as shown in FIG. The product V is kept in balance, and the intracranial pressure P is regulated by the intracranial compliance C.

Here, cerebrospinal fluid absorption 37, venous sinus inflow 39 and venous sinus outflow 40 have resistances Ri, Rvi and
Has Rvo.

And, the intracranial pressure-volume (PV) relationship is
As shown in Figs. 21 and 22, a logarithmic linear relationship with respect to the internal pressure P is obtained by Langfitt TWet:
Neurology, 15, 622/641, 1965, etc., it is known that the slope of this straight line is the PVI
(pressure-volume idex).

Therefore, if the production and resistance of each part of the intracranial system can be completely ignored, the intracranial compliance C
is expressed as a function of intracranial pressure P as shown in the following equation.

C≡ΔV/ΔP−PVI/P……(1) In other words, if a predetermined volume of ΔV is injected at once and the intracranial pressure change ΔP is measured, the intracranial pressure P at that time is
Compliance C can be measured.

However, the above-mentioned assumption that the resistance of each part can be ignored does not hold true in an actual system (however, cerebrospinal fluid production can be ignored if it occurs within a few minutes), and we have devised ways to measure compliance C. It takes. Previous research has attempted several methods for measuring compliance C, but the simplest method is a method in which a known amount of volume ΔV is rapidly injected in an extremely short period of time (theoretically from t to 0). [bolus
injection (infusion) method] is commonly used, and the compliance C is determined from the time response curve of the intracranial pressure P to this method.

Ignoring cerebrospinal fluid production and assuming that the total resistance of cerebrospinal fluid absorption and venous sinus inflow is R _T , each parameter of the intracranial system is
PVI, R _T , and C are theoretically determined by the following equations.

PVI=ΔV/log ₁₀ (Pa/P ₀ ) [ml] ...(2) R _T =t _P2 P ₀ /PVI・log ₁₀ [P ₂ /P
_P・P _P −P ₀ /P ₂ −P ₀ ] [mmHg/ml/min]……(3) C=0.4343PVI/P ₀ [ml/mmHg]……(4) Here, in Figure 23 As shown, P ₀ , P _P , t _P2
and P ₂ can each be measured, P ₀ means the intracranial pressure before injection, P _P the maximum intracranial pressure at the time of injection, t _P2 the time constant, and P ₂ mean the intracranial pressure at t _P2 .

Conventionally, as this rapid injection means (pressure increase means), the one shown in FIG.
A silicone resin is provided with a tubular ventricular catheter 2 into which b is inserted and which can discharge cerebrospinal fluid from the same ventricle, and a reservoir 70 connected to the catheter 2, and which is fixed on the skull 17 under the scalp 16. It consists of an implant main body made of a soft wall made of plastic, etc., and a peritoneal catheter 3 that connects the abdominal cavity and atrium of the implant main body, and an intracranial drug solution (distilled water, physiological saline, etc.) ) An injection dome 70a is formed.

In addition, the code|symbol 71 in the figure has shown the interruption|blocking part in the flow path 13 pressed by the finger|toe 18, 72 is an anti-siphon device, 73 is a diaphragm or a diaphragm sheet, and 74 is a injection needle.

Furthermore, an intracranial pressure measuring device (not shown) is provided, and this intracranial pressure measuring device includes a pressure sensor buried under the scalp, an electric wire, etc. connected to the pressure sensor and led out to the outside, and the same electric wire, etc. It consists of a meter, etc. that outputs the signal from the

An example of the measurement is shown in FIG.

Here, at time t ₀ , three different predetermined volumes of chemical solutions ΔV are injected, and each of the curves (a) to (c) is obtained.

[Problem that the invention seeks to solve]

In such conventional intracranial compliance measuring means, the following problems arise in the rapid injection means.

(1) Frequent injection of chemical solutions may damage the scalp 16 and pose a risk of bacterial infection.

(2) The patient's posture must be maintained, which is painful and makes long-term measurements difficult over several days.

The present invention aims to solve these problems by adding a simple means to the ventricular shunt, making it possible to perform frequent intracranial compliance measurements, and reducing the risk of bacterial infection. This makes it possible to easily handle objects buried in the body by preventing
The purpose of this invention is to provide a ventricular shunt device that can also be used to measure intracranial compliance.

[Means for solving problems]

Therefore, the ventricular shunt device for intracranial compliance measurement of the present invention includes a ventricular catheter whose tip is inserted into the ventricle to drain cerebrospinal fluid from the same ventricle, and a ventricular catheter whose tip is inserted into the abdominal cavity or atrium. a peritoneal catheter or an atrial catheter that can be inserted into the peritoneal cavity or the atrium to deliver the cerebrospinal fluid to the same peritoneal cavity or the atrium; and each catheter connected to the proximal end of the ventricular catheter and the proximal end of the peritoneal catheter or the atrial catheter, respectively. The shunt body is provided with a check valve capable of preventing backflow of cerebrospinal fluid from the peritoneal catheter or the atrial catheter to the ventricular catheter, and the shunt body is provided with a shunt body that allows the ventricular catheter to communicate with the peritoneal cavity. A cutoff valve mechanism capable of blocking the flow of cerebrospinal fluid to a catheter or an atrial catheter, and an intracranial compliance measurement device that is inserted into a flow path closer to the ventricular catheter than the cutoff valve mechanism and that guides the cerebrospinal fluid. a reservoir, and a cerebrospinal fluid reflux reservoir that communicates with the reservoir and is capable of refluxing a predetermined volume of cerebrospinal fluid stored therein toward the cerebral ventricle in response to an external force; The upper part is provided with a flexible convex curved dome for intracranial compliance measurement, which is formed to protrude outward, is expanded by the pressure of the cerebrospinal fluid, and can be bent in response to pressure from an external force; A detection end consisting of a guide part that can be contacted from the outside through the scalp and a pressure receiving part whose tip is formed so as to be substantially flush with the tip of the guide part, and connected to the pressure receiving part of the detection end. It is characterized by comprising a pressure sensor and an external device that receives and displays or records a detection signal from the pressure sensor.

[Effect]

In the above-mentioned ventricular shunt device for intracranial compliance measurement of the present invention, by pressing the cerebrospinal fluid reflux reservoir, cerebrospinal fluid is refluxed toward the ventricle, and from the ventricle through the ventricular catheter, it is used for intracranial compliance measurement. As cerebrospinal fluid is guided to the reservoir, the curved dome of the reservoir is expanded by the pressure of this cerebrospinal fluid, and the guide part and pressure receiving part at the detection end of the pressure sensor are brought into contact with the curved dome through the scalp, and the detection end The pressure sensor detects the pressure according to the pushing state, and the external device displays or records it, and the inflection points (i.e., the inflection point of the detected pressure according to the pushing depth) are determined from the pushing depth and the detected pressure. The detected pressure at the point) and its vicinity is the intracranial pressure.

Intracranial compliance is then measured by detecting this temporal change in intracranial pressure.

Furthermore, in the above-mentioned intracranial compliance measuring and ventricular shunt device of the present invention, by opening its isolation valve mechanism, excess cerebrospinal fluid in the ventricles is discharged to the peritoneal cavity or atrium in the same manner as in a normal ventricular shunt. A draining action is performed.

〔Example〕

Embodiments of the present invention will be described below with reference to the drawings. FIGS. 1 to 6 are shown to explain the intracranial compliance measuring means in the intracranial compliance measuring and ventricular shunt device of the present invention, and FIGS. Figure 14 shows a ventricular shunt device for intracranial compliance measurement as the first embodiment of the present invention, and Figures 15 and 16 show modified examples of the isolation valve mechanism in the first embodiment of the present invention. 17 and 18 show the ventricular shunt in the intracranial compliance measuring and ventricular shunt device as the second embodiment of the present invention, and FIG. 19 shows the ventricular shunt as the third embodiment of the present invention. This shows a ventricular shunt device that also serves as an intracranial compliance measurement.
The same reference numerals as in FIGS. 0 to 25 indicate substantially the same things.

As shown in FIGS. 1 to 6, the intracranial compliance measuring means in the intracranial compliance measuring and ventricular shunt device of the present invention includes an implant A to be implanted inside the patient's body and an implant A to be implanted outside the patient's body. , an extracorporeal device B that can come into contact with the intracranial compliance measurement reservoir 11 of the implant A through the scalp 16, and functionally includes a rapid injection means (pressure increase means) 80 and an intracranial pressure measuring means. 9
It is composed of 0.

The implant A includes a tubular ventricular catheter 2 whose tip end 2b can be inserted into a patient's ventricle 19 to drain cerebrospinal fluid from the ventricle 19, and a reservoir 11 connected to the catheter 2. A predetermined volume V ₀ (=V ₂ −
V ₁ ) made of silicone resin and fixed on the skull 17 below the scalp 16 and equipped with a cerebrospinal fluid reflux reservoir 40 as a rapid injection means (pressure increasing means) 80 capable of refluxing the cerebrospinal fluid toward the cerebral ventricle 19 The reservoir 11 has a flexible convex curved dome 11a for intracranial compliance measurement formed in the upper part of the reservoir 11.

Here, V ₂ is the internal volume of the reservoir 40 when the upper curved dome 40a of the reservoir 40 is not pressed;
V ₁ indicates the internal volume of the reservoir 40 when the upper curved dome 40a of the reservoir 40 is pressed.

The pressure detection device, which is a main part of the intracranial pressure measurement means 90, includes a pressure detector 23 and a pressure detection signal from a pressure sensor 23e of the pressure detector 23, which is connected to a lead wire 2.
an amplifier 25 for receiving and amplifying the signal via a lead wire 26; and a recorder 2, such as a printer, for receiving and recording the amplified signal from the amplifier 25 via a lead wire 26.
7 and a display device 28 such as a CRT for display.

The pressure detector 23 is configured as a transcutaneous cerebral pressure sensor, and includes a case 23a, an outer cylinder 23b of a predetermined length connected to the detection end side of the case 23a,
A presser plate 23c connected to the back side of the case 23a
and a columnar pressure receiving part 23d slidably inserted into the outer cylinder 23b, which is connected to the pressure receiving part 23d, converts the pressure from the pressure receiving part 23d into an electrical signal, and outputs it via the lead wire 24. A diffusion-type semiconductor pressure sensor (or load sensor) 23e whose surface is molded with silicon for the purpose of increasing the pressure, and a hard spring 23 that applies a biasing force to the pressure sensor 23e inside the case 23a.
f, and a zero adjuster 23g for positioning the pressure sensor 23e.

In addition, the code|symbol 20 in a figure shows a brain, and 21 shows a dura mater.

Since the intracranial compliance measuring means in the intracranial compliance measuring and ventricular shunt device of the present invention is configured as described above, with the buried object A buried in a predetermined position, Intracranial compliance C can be measured.

(1) Before performing rapid injection, perform step b5 described below.
As shown in ~b7, the intracranial pressure P is measured once and set as _P0 [see steps b1, b3 and time _t1 in Figure 5b].

(2) Reservoir 11 for intracranial compliance measurement buried under the scalp 16 and above the skull 17
Then, the cerebrospinal fluid is guided to the cerebrospinal fluid circulation reservoir 40 through the ventricular catheter 2, and the reservoir 40 in the rapid injection means 80 is pressed, and a predetermined volume of cerebrospinal fluid is directed toward the cerebral ventricle 19 at once by the rapid injection method. Reflux [see step b4 and time _t0 in Figure 5b].

(3) The upper dome 11a of the reservoir 11 is expanded to protrude outward due to the pressure of the cerebrospinal fluid (step b5).

(4) Turn on the pressure detection device and start measurement [see sensor depth L _A at time t _A in Figures 4a and 5a]. At this time, the detection end 30
is separated from the scalp 16 and is in a non-contact state.

Therefore, in this state, no pressure is applied to the dome 11a from the outside.

(5) By bringing the detection end 30 of the pressure detection device into contact with the upper dome 11a through the scalp 16 [see sensor depth L _B at time t _B in FIGS. 4b and 5a], the pressure is detected. Measurement of P is started (step b6).

(6) Next, push the detection end 30 into the upper dome 11a until the center of the upper surface becomes flat [sensor depth L _c at time t _c in Fig. 4 c and Fig. 5 a]
reference].

In this state, the distal end surface of the pressure receiving part 23d and the distal end surface of the guide part 23b and the upper surface of the curved dome 11a via the scalp 16 are in a co-plane.
In this state, the indentation depth L and detected pressure P
An inflection (hereinafter, this inflection point will be referred to as "BP ₁ ") occurs in the relationship.

(7) Further, the pushing is continued until the surface of the upper dome 11a is crushed [see sensor depth L _D at time t _D in FIG. 4 d and FIG. 5 a].

In this state, the tip end surface of the pressure receiving part 23d is attached to the scalp 1.
6 and the guide portion 2 by the curved dome 11a.
The guide portion 23 is pushed up relative to the guide portion 3b.
In the state in which the indentation point begins to sink into the inside part b, an inflection occurs in the relationship between the indentation depth L and the detected pressure P (hereinafter, this inflection point will be referred to as "BP ₂ ").

(8) The pressure detected by the pressure detection device during this pushing process is recorded by the recorder 27, and the display device 2
The detection pressure P is measured by displaying 8, and even if the pushing depth L of the detection end 30 is slightly changed, the detection pressure P
A section (inflection points BP ₁ to _{BP 2} ) in which there is no change is detected, and the detected pressure P in this section is taken as the intracranial pressure (step b7).

That is, the indentation depth L and the detected pressure P have a characteristic of having two inflection points BP ₁ and BP ₂ , and here, the verification width is small between the inflection points BP ₁ and BP ₂ .

(9) Intracranial pressure measuring means 90 in (3) to (9) above
The intracranial pressure is measured using a predetermined time width Δt (30 seconds to 1
The detection pressure P is plotted every predetermined number of times (or until a predetermined time elapses) (see steps b3, b8, b9 and times _t2 to _t0 in FIG. 5b).

(10) According to (9) above, each plot is interpolated by a curve,
Estimate the response curve. Thereby, each of the parameters PVI, _RT , and C can be determined based on equations (2) to (4).

The principle of transcutaneous intracranial pressure measurement performed in this way is based on the premise that the following conditions hold:
This is done for the following measurement objects.

First, as shown in FIG. 1, the conditions are that intracranial pressure is derived directly below the scalp 16, and that a pressure equal to the intracranial pressure exists in the "soft" dome 11a of radius r.

In this case, the measurement target is the implant body 22 (ventricular shunt body 1) embedded under the scalp 16.
This pressure is measured indirectly from the outside of the scalp 16. At this time, it is assumed that there is almost no change in intracranial pressure even if the scalp 16 and reservoir 11 are lightly compressed.

At this time, the following measurement principle is derived from Laplace's theorem.

As shown in FIG. 6a, the dome 11a of the scalp 16 and the implant body 22 (ventricular shunt body 1)
is part of a sphere with radius r, the sphere has an internal pressure (brain pressure) Pi and an external pressure (usually atmospheric pressure)
Laplace's theorem is established between P ₀ and the tension T of the dome 11a of the scalp 16 and the buried object body 22.

That is, the following relationship holds true.

Pi−P ₀ =2T/r (5) Here, when measuring the internal pressure Pi from outside the dome 11a, the condition that Pi=P ₀ should be satisfied under the equation (5).

Based on Laplace's theorem, the following measurement principle is established.

Now try pressing the outside of the dome 11a with a plate 29 as shown in FIG. 6b. The upper surface of the dome 11a is made flat by the plate 29. Assuming that the area of the planar portion of this plate 29 is D, in the region of D, r is equivalent to infinity when considered based on Laplace's theorem.

That is, if r is ∞, the right side of equation (5) becomes 0, and in this case, Pi=P ₀ holds true. From this, it can be seen that when the dome 11a and the scalp 16 are compressed with an appropriate external pressure, the external pressure applied to the flattened portion becomes equal to the internal pressure.

However, in actual measurements, it is necessary to pay attention to the following points in order to accurately compress only the necessary portions of the dome 11a.

To compress the dome 11a in a flat shape. To detect external pressure only in the region D above. To not crush the dome 11a more than necessary. When these conditions are satisfied, actual measurement can be performed.

As described above, according to the intracranial compliance measuring means in the intracranial compliance measuring and ventricular shunt device of the present invention, the buried object A can be
It can be configured so as not to interfere with the creation of tomographic images using scanners, nuclear magnetic resonance scanners, or the like.

As shown in FIGS. 7 to 14, the ventricular shunt device for intracranial compliance measurement as the first embodiment of the present invention is a ventricular shunt device for intracranial compliance measurement as an implant to be implanted in the patient's body. A ventricular shunt A ₁ for intracranial compliance measurement and function is used, and the extracorporeal equipment B, rapid injection means 80, and intracranial pressure measurement means 90 are almost the same as those described above.

The intracranial compliance measuring ventricular shunt A ₁ used as an implant in this example has the function of a flow rate switching type ventricular shunt, and its tip 2b is inserted into the patient's ventricle 19. A tubular ventricular catheter 2 that can drain cerebrospinal fluid from the ventricle 19, and a peritoneal catheter or atrial catheter (hereinafter referred to as " ) 3, the proximal end 2a of the ventricular catheter 2, and the proximal end 3a of the peritoneal catheter 3.
If the shunt body (relay chamber) is made of a soft wall made of silicone resin or the like, it has a main passage 10 that is connected to the catheters 2 and 3 and communicates with each other.
It is composed of 1.

In addition, the shunt main body 1, the ventricular catheter 2, and the peritoneal catheter 3 are provided with a check valve 4 that can prevent backflow of cerebrospinal fluid from the peritoneal catheter 3 to the ventricular catheter 2. valve 4
In this embodiment, slit relief valves 6 and 7 serving as flow rate adjusting sections of a flow rate switching mechanism 5, which will be described later, also serve this function.

These slit type release valves 6 and 7 are
As shown in FIG. 4, a relief valve equipped member 33 is formed integrally with valve seats 8a and 9a, which will be described later.
It is sandwiched between the upper part 1A and lower part 1B of the shunt main body 1 and is bonded to the latter.

That is, the shunt main body 1 is separated into an upper part 1A and a lower part 1B at the hatched portion in FIG. 7, and is assembled by adhering them to each other.

The shunt main body 1 is attached to the scalp 16 by suturing a suture or the like passing through the suture through hole 15 to the scalp 16.
A main passage 10 is fixed on the skull 17 at the bottom of the main passage 10 and is connected to the ventricular catheter 2 and the peritoneal catheter 3, and a small chamber-shaped reservoir 11 is formed on the side of the ventricular catheter 2 of the main passage 10. , communicates with this reservoir 11 via a communication path 41, receives external force through the scalp ₁₆ , and directs a predetermined volume of cerebrospinal fluid stored _therein to the ventricle ₁₉ . A cerebrospinal fluid reflux reservoir 40 as a rapid infusion means (pressurization means) 80 that can be refluxed, a small chamber 12 formed on the peritoneal catheter 3 side of the main passage 10, and a branch in the main passage 10 downstream of the reservoir 11. It is configured with a first flow path 13 and a second flow path 14 that connect the small chamber 10a and the small chamber 12 in parallel.

Here, V ₂ is the internal volume of the reservoir 40 when the upper curved dome 40a is not pressed against the reservoir 40;
V ₁ indicates the internal volume of the reservoir 40 when the upper curved dome 40a of the reservoir 40 is pressed.

In the first flow path 13, as shown in FIG.
A slit ₆ with a predetermined depth D 1 that can adjust the flow rate in the communication state of this first channel 13 to a predetermined flow rate Q ₁
a, and a slit type relief valve 6 as a first flow rate adjustment part formed with a slit type relief valve 6 as a first flow rate adjustment part, and as a first opening/closing valve that can receive a driving force from the outside of the shunt body 1 and block this first flow path 13. A ball type on-off valve 8 is inserted.

The ball type on-off valve 8 includes a circular valve seat 8a formed on the wall surface of the shunt main body 1, a valve chamber 8b formed in a first flow path 13 on the upstream side opposite to the circular valve seat 8a, and a valve chamber 8b formed in a first flow path 13 on the upstream side opposite to the circular valve seat 8a. A movable spherical valve body 8c that is enclosed in the chamber 8b and can be moved by receiving a driving force from a finger 18 or the like from the outside of the soft upper wall 1a and the soft front wall 1b of the valve chamber 8b and the scalp 16, and the valve body 8c. When seated, the on-off valve 8 is held between the soft upper wall 1a and the valve body 8c aligned with the valve seat 8a.
A circular seat (recess) 8d for holding the closed position that closes the first flow path 13 and blocks the first flow path 13, and a soft upper wall 1a at a position where the valve body 8c is separated from the valve seat 8a by seating the valve body 8c. The on-off valve 8 is sandwiched between
and a circular seat (recess) 8e for holding the open position, which opens the first flow path 13 and communicates with the first flow path 13.

In the second flow path 14, as shown in FIG.
A second slit 7a having a predetermined depth D ₂ (<D ₁ ) that can adjust the flow rate in the communicating state of the second flow path 14 to a predetermined flow rate Q ₂ (here, = 1/2Q ₁ ) is formed.
Slit type relief valve 7 as a flow rate adjustment part
A ball-type on-off valve 9 serving as a second on-off valve capable of blocking the second flow path 14 by receiving a driving force from the outside of the shunt body 1 is inserted.

The ball type on-off valve 9 includes a circular valve seat 9a formed on the wall surface of the shunt main body 1, a valve chamber 9b formed in a second flow path 14 on the upstream side opposite to the circular valve seat 9a, and a valve chamber 9b formed in a second flow path 14 on the upstream side opposite to the circular valve seat 9a. A movable spherical valve body 9c that is enclosed in the chamber 9b and can be moved by receiving a driving force from a finger 18 or the like from the outside of the soft upper wall 1a and the soft front wall 1c of the valve chamber 9b and the scalp 16, and the valve body 9c. When the valve body 9c is seated, it is held between the soft upper wall 1a and the open/close valve 9 at a position where the valve body 9c is aligned with the valve seat 9a.
and a soft upper wall 1a at a position where the valve body 9c is separated from the valve seat 9a by seating the valve body 9c. The on-off valve 9 is sandwiched between
The ball-type on-off valve 9 is composed of a circular seat (recess) 9e for holding the open position and communicates the second flow path 14 with the upstream ball-type on-off valve 8.
It is structured almost the same way.

The first relief valve 6 has a larger regulated flow rate than the second relief valve 7, and in this embodiment, each of the relief valves 6 and 7 is configured as a single-slit check valve. However, these may be changed to a cross-slit type, a spring-equipped type, or a membrane type.

The movable spherical valve bodies 8c, 9c may be made of plastic or metal, but metal balls coated with silicone resin may also be used.
In the case of movable spherical valve bodies made of plastic, it is desirable to mix a contrast medium into the plastic material so that the position of the movable spherical valve bodies 8c, 9c can be confirmed by X-ray photography as in the case of metal. .

As mentioned above, the flow rate switching mechanism 5 controls the predetermined flow rate.
A _first flow rate switching section 5a includes a slit type relief valve 6 and a ball type on-off valve 8 inserted in the flow path 13 to control the flow rate of Q1, and a predetermined flow rate _Q2.
(=1/2Q ₁ ), the second flow rate switching section 5b includes a slit type relief valve 7 inserted in the flow path 14 and a ball type on-off valve 9. The moving directions F ₁ and F ₂ of the valve bodies 8c and 9c in these on-off valves 8 and 9 are parallel to each other and parallel to the center line CL of the shunt body 1.

Furthermore, the valve chambers 8b, 9 of the ball type on-off valves 8, 9
The orientation of the valve seats 8a and 9a facing b is the same as that of the valve body 8c,
It is set to tilt toward the center from the moving directions F ₁ and F ₂ of 9c.

That is, the center of the small chamber 12 and the circular seats 8d, 9d
The first channels 13 and 14 are formed so as to connect the center positions of the circular seats 8d and 9 with a straight line, respectively.
d to the circular seat 8e, on the moving direction of the valve bodies 8c, 9c.
If you follow the direction opposite to 9e, you will immediately see the shunt body 1.
Soft rear walls 1d and 1e forming the outer walls of the vehicle are arranged.

Moreover, the first and second flow rate switching parts 5a, 5b
has a function as a shutoff valve mechanism 34 by simultaneously closing the valve.

Since the ventricular shunt device for intracranial compliance measurement as the first embodiment of the present invention is constructed as described above, the ventricular shunt device A for intracranial compliance measurement is buried in a predetermined position, and the Intracranial compliance can be measured by performing the following procedure (0) before the procedures (1) to (10) described in FIGS.

(0) Closing the shutoff valve mechanism 34 that can shut off the flow of cerebrospinal fluid from the ventricular catheter 2 to the peritoneal catheter 3 in the shunt body 1 to shut off the flow of cerebrospinal fluid [dashed line in FIG. See step b2 in the figure].

In this case, the shutoff valve mechanism 34 is operated by simultaneously closing the first and second flow rate switching sections 5a and 5b.

The intracranial compliance measurement/ventricular shunt device of this embodiment has the function of measuring the intracranial compliance described above, as well as the function of switching the flow rate as described below.

As shown in FIG. 11d, the movable spherical valve body 8c,
9c are seated on the open position retaining seats 8e and 9e, respectively, the cerebrospinal fluid that has flowed from the patient's ventricle 19 through the ventricular catheter 2 into the reservoir 11 flows through the main passage 10 and the first and second flow path 1
3 and 14, enters the valve chambers 8b and 9b, and enters the valve chambers 8b and 9b.
It passes through the open valves 8 and 9 and enters the upstream side of the relief valves 6 and 7.

At this time, if the difference between the pressure of the cerebrospinal fluid upstream of the relief valves 6 and 7 and the pressure of the cerebrospinal fluid downstream of the relief valves 6 and 7 is equal to or greater than a predetermined value, the relief valves 6 and 7 become open, and the small chamber 1
The cerebrospinal fluid flows into the small chamber 12, and the cerebrospinal fluid in the small chamber 12 further flows into the patient's abdominal cavity and atrium through the peritoneal catheter 3.

In this way, the cerebrospinal fluid from the ventricle flows at the maximum flow rate as the sum (Q ₁ +Q ₂ ) of the respective regulated flow rates of the two relief valves 6 and 7.

Next, if you want the flow rate to be medium _Q1 , as shown by the chain line in FIG. It is sufficient to seat the movable spherical valve body 9c on the circular seat 9d and close the second on-off valve 9, thereby allowing the cerebrospinal fluid to flow only through the first relief valve 6, which has a relatively large regulated flow rate. I can do it.

Also, if you want to make the flow rate even smaller, _Q2 ,
As shown by the solid line in FIG. 7, the movable spherical valve body 8c
The movable spherical valve body 9c is seated on the circular seat 8d to close the first on-off valve 8, and the second on-off valve 9 is closed by placing the movable spherical valve body 9c on the circular seat 9e. It can flow only through the second relief valve 7, which has a relatively small regulated flow rate.

As described above, in this embodiment, the first relief valve 6 and the second relief valve 7 have different regulated flow rates, so the two relief valves 6 and 7 can switch the flow rate in three stages and Although shutoff is performed, even if both relief valves 6 and 7 have the same regulated flow rate, the flow rate can be switched in two stages: when the flow is allowed to flow only to one of them, and when the flow is allowed to flow to both. can.

When it is desired to stop the outflow of cerebrospinal fluid via this ventricular shunt, the movable spherical valve bodies 8c and 9c are guided to the closed position holding seats 8d and 9d, respectively, and the first
Then, both the second on-off valves 8 and 9 are closed to block the flow of cerebrospinal fluid from the reservoir 11 to the relief valves 6 and 7 through the main passage 10 and the first and second flow passages 13 and 14. Bye.

In addition, in this embodiment, as shown in FIGS. 11a to 11d, the valve bodies 8c and 9c are held in the closed position by
d, 9d toward the open position holding circular seats 8e, 9e, the soft upper wall 1a and the soft rear wall 1d, 1e may be pressed with the fingers 18 through the scalp 16.

Further, when moving the valve bodies 8c, 9c from the open position holding seats 8e, 9e to the closed position holding seats 8d, 9d, the soft upper wall 1a and the soft front wall 1b, 1c are moved from the scalp 16. All you have to do is press it with your finger 18.

According to this embodiment, the moving direction of the valve bodies 8c, 9c
Since F ₁ and F ₂ are configured to be parallel to each other, it is easy to see or touch the open/close states of the on-off valves 8 and 9.

As shown in FIGS. 15 and 16, in the modified example of the cutoff valve mechanism in the ventricular shunt device for intracranial compliance measurement as _the first embodiment of the present invention, there is a From the ventricular catheter 2 to the peritoneal catheter 3,
A pump chamber 31 for opening a shutoff valve that communicates with the reservoir 11 and a shutoff valve mechanism 3 that can shut off the flow path 13.
Button type cutoff valves 32 shown in FIG. 4 are sequentially arranged.

This button-type cutoff valve 32 communicates with the pump chamber 31 for opening the cutoff valve of the shunt main body 1, and has an opening 32e in the channel 13 on the side of the peritoneal catheter 3.
A flexible membrane 32a is formed around the opening 32e and a flexible membrane 32a that forms the upper wall surface of the valve chamber 32f and can be dented by receiving an external force from a finger 18 or the like. Valve seat 32c and the flexible membrane 32
It is configured as a push-type on-off valve including a protruding valve body 32b that is attached to the side wall surface of the valve chamber 32f and can close the opening 32e when the flexible membrane 32a is pressed downward.

In order to operate the cutoff valve mechanism 34 of this modified example, as shown by the chain line in FIG.
is pressed to push the protruding valve element 32b attached to the lower center of the flexible membrane 32a into the opening 32e of the intermediate partition membrane 32d, which is the valve seat 32c, thereby closing the opening 32e.

Note that in order to open the shutoff valve mechanism 34,
By pressing the flow path 13 on the upstream side of the pump chamber 31 for opening the cutoff valve with a finger 18 through the scalp 16, and pressing the upper flexible membrane 31a while the flow path 13 is blocked, the valve chamber 32f is opened. The pressure inside is increased and the valve body 32b is separated from the opening 32e, thereby opening the shutoff valve mechanism 34.

As shown in FIGS. 17 and 18, in the intracranial compliance measuring and ventricular shunt device as the second embodiment of the present invention, the intracranial pressure measuring means 90 is
A cerebrospinal fluid circulation reservoir 40, which is different from the first embodiment and has the same function as the first embodiment, is provided directly above the proximal end 2a of the ventricular catheter 2, and is used for intracranial compliance measurement. Reservoir 11
is omitted, and the following devices are also provided.

That is, as shown in FIGS. 17 and 18, a ventricular shunt A ₃ as an implant and an extracorporeal device B are provided, and this ventricular shunt A ₃ is a tubular brain inserted into the ventricle. A shunt body (relay chamber) 52 consisting of a ventricular catheter 2 and a reservoir and a pump chamber connected to the ventricular catheter 2
The shunt main body 52 is connected to a tube-shaped peritoneal catheter or an atrial catheter 3 which is inserted into the abdominal cavity or atrium.

The shunt main body 52 is buried on the skull 17 under the scalp 16, and the shunt main body 52
A relief valve 54 and a shutoff valve mechanism 34 are provided inside the ventricle, and are constructed of a miter valve or the like that can be pushed open by the pressure of cerebrospinal fluid, which is fluid discharged from the ventricles.

Further, the shunt main body 52 has a flow path 13 therein.
A flexible diaphragm 55 is formed at the upper part of the flow path 13 and can expand upward according to the pressure of the spinal fluid flowing in the flow path 13, and a flexible diaphragm 55 is formed at the lower part of the flow path 13 and faces the flexible diaphragm 55. A diaphragm stopper 56 is provided, and an embedded pressure sensor 57 constituting a part of an intracranial pressure measuring means (pressure detection device) 90 is provided in the flow path 13 of this shunt body 52. This embedded pressure sensor 57 is embedded in the shaft main body 52 forming the diaphragm stopper 56 and has a tuning circuit 58 having a resonant circuit such as a coil, and a tuning circuit 58 which is embedded in the shaft main body 52 forming the diaphragm stopper 56 and is connected to a tuning circuit 58 having a resonant circuit such as a coil, The tuning element 59 is attached to the roadside and changes the resonance frequency of the tuning circuit 58 according to the distance between the tuning element 59 and the tuning circuit 58.

And intracranial pressure measuring means (pressure detection device) 9
0 is comprised of the above-mentioned embedded pressure sensor 57 embedded within the patient's body and the following members provided outside the patient's body. That is, outside the body, there is an antenna 61 that sends electromagnetic waves to the pressure sensor 57 in order to detect the resonance frequency in the pressure sensor 57;
An electronic device 62 that receives a change in the signal sent to the antenna 61 and indicates that it is at a resonant frequency is provided, and the above-mentioned flexible diaphragm 5
5 through the scalp 16 , a non-metallic pressurizing body 63 , which is inflated by air pressure in order to bring the tuning element 59 of the embedded pressure sensor 57 closer to the tuning circuit 58 , is inserted between the scalp 16 and the antenna 61 . A compressed air supply device 64 that supplies compressed air to the pressurizing body 63 and a pressure gauge 65 that detects the pressure of the compressed air supplied from the compressed air supply device 64 are provided. .

In this example, intracranial pressure is measured by the following procedure.

<1> An electronic device receiving a signal from the antenna 61 by placing the antenna 61 at the detection position, pressing the diaphragm 55 with the finger 18 through the scalp 16, and bringing the tuning circuit 58 and the tuning element 59 close together. 62 calibration is performed.

<2> In the state of <1>, the finger 18 is released, the diaphragm 55 expands outward, the tuning circuit 58 and the tuning element 59 are separated, and the display of the electronic device 62 is calibrated by the signal from the antenna 61. Make sure you leave the area.

<3> Here, similarly to step (2) in the operation procedure of the intracranial compliance measuring device described above, the cerebrospinal fluid reflux reservoir as the rapid injection means 80 buried under the scalp 16 and on the skull 17 40 through the ventricular catheter 2, the reservoir 40 is pressed, and a predetermined volume of cerebrospinal fluid is refluxed at once toward the ventricle 19 by rapid injection.

<4> Insert the pressurizing body 63 between the scalp 16 and the antenna 61 and apply pressure until the display on the electronic device 62 is in the calibration range. At this time, the pressure measured by the pressure gauge 65 is applied to the skull. Let it be the internal pressure.

<5> Here, (9) and (10) in the above operating procedure
In the same way as above, each parameter PVI, R _T ,
C can be found.

As shown in FIG. 19, in the intracranial compliance measuring and ventricular shunt device as the third embodiment of the present invention, an intracranial pressure measuring means 90 is different from that in the first embodiment, and is similar to that in the first embodiment. A cerebrospinal fluid circulation reservoir 40 serving as a functional rapid injection means 80 is connected to a sensor main body 66, which will be described later, via a communication path 41, and the following devices are also provided.

That is, the intracranial pressure measuring device in this embodiment is composed of a ventricular shunt A ₄ buried under the scalp 16 and an extracorporeal device B.
A ₄ is provided with a sensor main body 66 that is inserted into the flow path 13 and displaces the passive element according to intracranial pressure, and the extracorporeal device B is arranged so as to surround the passive element in the sensor main body 66. It includes a probe (antenna) 67 that approaches the top, and a meter (control device) 69 that measures intracranial pressure according to the absorption rate of electromagnetic waves emitted from the probe 67 in passive elements.

In addition, the code|symbol 68 in the figure has shown the wiring which connects the probe 67 and the meter 69, and the code|symbol already mentioned has shown the same thing as the above-mentioned Example.

In this embodiment as well, the effects detailed in the first and second embodiments can be obtained, and the intracranial pressure can be continuously determined with the intracranial pressure measuring device, and the intracranial pressure can be recorded with the recorder 27 and the display device 28. Based on the data displayed, the intracranial compliance C can be measured.

Furthermore, the number of flow rate switching units in each embodiment may be three or more, and the regulated flow rates may be set to be different from each other. For example, the regulated flow rate may be set to ²ⁿ times the minimum flow rate Q, where n is a natural number. If you have
It is possible to switch the flow rate in (2 ⁿ -1) steps, and
A mechanism as a shutoff valve mechanism 34 can be provided.

In addition, in each of the above-mentioned embodiments, orifices with different flow rates may be provided in place of the relief valves 6 and 7, and in this case, the first and second flow paths 1
3 and 14, respectively, or a single check valve is inserted in the main passage 10.

Further, the first and second flow rate switching sections 5a and 5b may be configured such that the moving directions F ₁ and F ₂ of the valve bodies 8c and 9c are orthogonal to the center line CL of the shunt body 1.

Furthermore, the valve chambers 8b, 9b and the small chamber 12 may be arranged vertically.

〔Effect of the invention〕

As described above in detail, the intracranial compliance measuring and ventricular shunt device of the present invention provides the following effects and advantages.

(1) There is no need to inject chemicals from the outside for compliance measurement, and there is no risk of bacterial infection or pain in maintaining the patient's posture.

(2) Since cerebrospinal fluid, which is a patient's body fluid, is refluxed toward the cerebral ventricles, there is no risk of problems associated with drug injection.

(3) It is easy to handle and does not cause invasiveness such as brain damage when not being measured.

(4) Burial surgery etc. can be performed easily.

(5) Can be realized at low cost.

(6) By opening the isolation valve mechanism, it can be used as a normal ventricular shunt.

[Brief explanation of drawings]

1 to 6 are shown to explain the intracranial compliance measuring means in the intracranial compliance measuring and ventricular shunt device of the present invention, and FIG. 1 is a schematic longitudinal cross-sectional view showing its measurement state, and FIG. The figure is a flowchart for explaining the measurement procedure, Figures 3a, b and 4a to d are schematic side views showing the measurement procedure, and Figure 5 is a flowchart for explaining the measurement procedure.
Figures a and b are graphs for explaining the action, and Figures a and b are schematic perspective views and side views for explaining the measurement principle.
7 to 14 show a ventricular shunt device for intracranial compliance measurement as a first embodiment of the present invention, and FIG. 7 is a cross-sectional view showing the ventricular shunt in this device (- arrow sectional view),
Figure 8 is a schematic longitudinal cross-sectional view showing the measurement state (the ventricular shunt is a cross-sectional view taken in the direction of the − arrow in Figure 7);
The figure is a sectional view taken along the - arrow in Figure 7, and Figure 10 is a cross-sectional view of Figure 7.
Figure 11a is a sectional view taken along the - arrow in the figure.XI in Figure 7
-XI arrow sectional view, Figures 11 b to d are all schematic diagrams for explaining the action at the time of burial, Figure 12 is a XII-XII arrow sectional view of Figure 7, and Figure 13 is a schematic diagram for explaining the action at the time of burial. 7 is a sectional view taken along the line X-X, and FIG.
FIG.
5 and 16 show modified examples of the shutoff valve mechanism in the first embodiment of the present invention, FIG. 15 is a schematic vertical sectional view thereof, FIG. 16 is a schematic plan view thereof, and FIG. Fig. 18 shows a ventricular shunt device for intracranial compliance measurement as a second embodiment of the present invention, Fig. 17 is a schematic diagram showing its overall configuration, and Fig. 18 is an enlarged sectional view showing its detection part. FIG. 19 is a schematic diagram showing the overall configuration of a ventricular shunt device for intracranial compliance measurement as a third embodiment of the present invention, and FIG.
Figure 25 shows a conventional intracranial compliance measuring means, Figure 20 is a schematic diagram showing its intracranial system model, Figures 21 to 23 are graphs showing its action, and Figure 24 shows its intracranial compliance measurement method. FIG. 25, which is a vertical cross-sectional view showing the main parts of the compliance measuring device, is a graph showing its operation. 1... Shunt main body (relay room), 1a... Soft upper wall, 1b, 1c... Soft front wall, 1d, 1e...
Soft posterior wall, 2...ventricular catheter, 2a... proximal end, 2b... distal end, 3... peritoneal catheter, 3
a... Base end portion, 4... Check valve, 5... Flow rate switching mechanism, 5a... First flow rate switching section, 5b... Second flow rate switching section, 6... First flow rate adjustment section Slit type relief valve as 6a...slit, 7...
Slit type relief valve as second flow rate adjustment section, 7a...Slit, 8...Ball type on/off valve as first on/off valve, 8a...Circular valve seat, 8b...
... Valve chamber (upstream compartment), 8c... Movable spherical valve body,
8d...Circular seat for holding closed position, 8e...Circular seat for holding open position, 9...Ball type on-off valve as second on-off valve, 9a...Circular valve seat, 9b...Valve chamber (upstream side) compartment), 9c...movable spherical valve body, 9d...
Closed position holding circular seat, 9e...open position holding circular seat, 10...main passage, 10a...branch, 11...
...Reservoir, 11a... Thin film-like flexible curved dome for intracranial pressure measurement, 12... Small chamber (downstream compartment),
13...first channel, 14...second channel, 15
... Suture hole, 16 ... Scalp, 17 ... Skull, 18 ... Finger, 19 ... Ventricle, 20 ... Brain, 2
DESCRIPTION OF SYMBOLS 1... Dura mater, 22... Buried object main body, 23... Pressure detector, 23a... Case, 23b... Outer cylinder as a guide part, 23c... Holding plate, 23d... Column pressure receiving part, 23e... ...Diffusion type semiconductor pressure sensor (load sensor), 23f...Zero adjuster, 24
... Lead wire, 25 ... Amplifier, 26 ... Amplifier, 27 ... Recorder as an external device, 28 ...
Display device as external device, 29... board, 30...
...Detection end, 31...Pump chamber for opening the shutoff valve, 31
a...Flexible membrane, 32...Button type cutoff valve (push type on/off valve), 32a...Flexible membrane, 32b...Protruding valve body, 32c...Valve seat, 32d...Intermediate partition membrane, 32e ...Opening, 32f...Valve chamber (empty space),
33... Member with relief valve, 34... Shutoff valve mechanism, 35... Intracranial, 38... Vascular system, 40...
Cerebrospinal fluid reflux reservoir, 41... communication path, 50...
Ventricular shunt, 52...shunt body (relay room),
53...peritoneal catheter or atrial catheter,
54... Relief valve, 55... Flexible diaphragm, 56... Stopper, 57... Buried pressure sensor, 58... Tuning circuit, 59... Tuning element, 60... Pressure detection device, 61... Antenna ,
62... Electronic equipment, 63... Pressurizing body, 64... Compressed air supply device, 65... Pressure gauge, 66... Sensor body, 67... Probe, 68... Wiring, 69
... Meter, 80 ... Rapid injection means (boosting means), 90 ... Intracranial pressure measuring means, A ... Buried object,
A ₁ to A ₄ ... Ventricular shunt for intracranial compliance measurement as an implant, B ... Extracorporeal device, C,
L...Center line.

Claims (1)

[Scope of Claims] 1. A ventricular catheter whose distal end is inserted into the ventricle of the brain to drain cerebrospinal fluid from the ventricle, and a catheter whose distal end is inserted into the abdominal cavity or atrium to drain the cerebrospinal fluid from the same ventricle. a peritoneal catheter or an atrial catheter capable of delivering fluid; a shunt body connected to the proximal end of the ventricular catheter and the proximal end of the peritoneal catheter or the atrial catheter, respectively, to communicate the catheters; and the peritoneal catheter. A check valve capable of preventing backflow of cerebrospinal fluid from the catheter or the atrial catheter to the ventricular catheter, and
The shunt body includes a cutoff valve mechanism capable of blocking the flow of cerebrospinal fluid from the ventricular catheter to the peritoneal catheter or the atrial catheter, and a flow path inserted into the ventricular catheter side of the cutoff valve mechanism. , and an intracranial compliance measurement reservoir for guiding the cerebrospinal fluid, and a cerebrospinal fluid reflux device that communicates with the reservoir and allows a predetermined volume of cerebrospinal fluid stored therein to be refluxed toward the cerebral ventricle in response to an external force. A flexible intracranial compliance is formed above the reservoir for intracranial compliance measurement so as to protrude outward, and is expanded by the pressure of the cerebrospinal fluid and can be bent in response to pressure from an external force. It is provided with a convex curved dome for measurement, and further includes a guide part that can come into contact with the convex curved dome from the outside through the scalp, and a pressure receiving part whose tip is formed so as to be substantially flush with the tip of the guide part. a detection end, a pressure sensor connected to the pressure receiving part of the detection end,
A ventricular shunt device for intracranial compliance measurement, characterized by comprising an external device that receives and displays or records detection signals from the same pressure sensor. 2. The shutoff valve mechanism operates the on-off valve by aligning a valve seat formed on the wall surface of the shunt body, a valve chamber formed in the shunt body upstream of the valve seat, and the valve seat. The valve is configured as a ball-type on-off valve having a spherical movable valve body enclosed in the valve chamber so as to be able to move to a closed position in response to a driving force from the outside of the shunt body.
The intracranial compliance measuring and ventricular shunt device according to claim 1. 3. A space in which the shutoff valve mechanism communicates with the intracranial compliance measurement reservoir of the shunt main body and also communicates with the peritoneal catheter side channel through an opening, and a flexible wall forming an upper wall surface of the space. a membrane, a valve seat formed around the opening, and a protruding valve body that is attached to the side wall surface of the cavity of the flexible membrane and can close the valve seat when the flexible membrane is pressed downward. The intracranial compliance measuring and ventricular shunt device according to claim 1, which is configured as a button-type on-off valve having the following.