KR102201288B1 - System for treating brain disease - Google Patents

Abstract

The present invention relates to a brain disease treatment system. The brain disease treatment system according to the present invention is implanted into the skull of a patient and includes an internal device including a two-way flow control valve; And an extracorporeal device positioned outside the patient's skull and supplying drugs to the intracorporeal device or discharging cerebrospinal fluid from the intracorporeal device, wherein the extracorporeal device includes: a drug injection unit including a pump; Drainage container for storing cerebrospinal fluid discharged from the body; A connection part connecting the internal device to the drug injection part and the drainage container; And a control unit for controlling the operation of the connection unit.

Description

Brain disease treatment system {SYSTEM FOR TREATING BRAIN DISEASE}

The present invention relates to a brain disease treatment system.

Ventricular premature ejaculation is a procedure to treat hydrocephalus, etc., and monitors the brain pressure (ICP) and drains the cerebrospinal fluid (CSF) based on this. If drainage is temporary, external ventricular drain (EVD) is performed, and in the long-term, ventricular-abdominal shunt is performed.

In the case of ventricular drainage, long-term drainage is difficult, and ventricular-abdominal shunt surgery is relatively complicated and difficult to administer drugs.

Republic of Korea Patent Publication No. 10-2016-0143502 (published on December 14, 2016)

It is an object of the present invention to provide a system for treating brain diseases in which long-term drainage is possible and both drug administration and cerebrospinal fluid drainage are possible.

It is an object of the present invention to provide a brain disease treatment system, comprising: an internal device implanted in the skull of a patient and including a bidirectional flow control valve; And an extracorporeal device positioned outside the patient's skull and supplying drugs to the intracorporeal device or discharging cerebrospinal fluid from the intracorporeal device, wherein the extracorporeal device includes: a drug injection unit including a pump; Drainage container for storing cerebrospinal fluid discharged from the body; A connection part connecting the internal device to the drug injection part and the drainage container; And a control unit for controlling the operation of the connection unit.

The bidirectional flow control valve includes: a valve body defining a flow path through which fluid moves; And a flow control unit positioned in the valve body, wherein the flow control unit includes: a first flow control unit and a second flow control unit that are movable in a flow path direction and face each other; A first pressing member for providing a pressing force to the first flow controller in the direction of the second flow controller; And a second pressing member for providing a pressing force to the second flow control body in a direction of the first flow control body, and in a state in which the first flow control body and the second flow control body are in close contact, the first flow control A part of the sieve directly contacts the fluid flow in the direction of the first flow path from the second flow control body toward the first flow control body, and a part of the second flow control body is the second flow path direction opposite to the first direction. Can be in direct contact with the fluid flow of

The connection unit may include a fluid line connecting the internal device, the drug injection unit, and the drainage container; And a flow path changer positioned on the fluid line and selectively connecting the internal device to the drug injection unit and the drainage container, and the controller may control the operation of the flow path changer.

The connection unit may include a flow meter measuring the flow rate of the fluid line; And a pressure gauge for measuring the pressure of the fluid line, and the controller may control the operation of the flow path converter based on a measurement result of the flowmeter and the pressure gauge.

The control unit calculates the brain pressure from the measurement result of the flow meter and the pressure gauge, and when the calculated brain pressure exceeds a certain value, the internal device is connected to the drainage container to control the operation of the flow path switch so that cerebrospinal fluid is discharged.

The drainage bag may be pressurized at a certain pressure.

The first flow control body and the second flow control body contact each other to close the flow path, and when a fluid flow of a certain level or higher occurs in the flow path, the first flow control body and the second flow control body are spaced apart from each other. The flow path can be opened.

The first pressing member and the second pressing member are made of elastic bodies having elastic force, and when a fluid flow of a certain level or more occurs in the direction of the first flow path, the first pressing member is deformed and the first flow control body When moving in the direction of the first passage to open the passage, and when a fluid flow of a certain level or more occurs in the direction of the second passage, the second pressure member is deformed and the second flow controller moves in the direction of the second passage. The flow path can be opened.

The flow control unit further includes a stopper positioned between the first flow control body and the second flow control body, wherein the stopper restricts movement of the first flow control body in the direction of the second flow path, and , It is possible to limit the movement of the second flow controller in the direction of the first flow passage.

The flow control unit further includes a support unit for restricting movement of the pressing member, and the support unit includes: a first support unit for restricting movement of the first pressing member in the direction of the first flow path; It may include a second support for limiting the movement of the second pressing member in the direction of the second flow path.

The first flow control body has a first through hole for exposing the second flow control body to the fluid flow in the direction of the second flow path, and the second flow control body does not communicate with the first through hole and does not communicate with the first through hole. A second through hole for exposing the first flow controller to the fluid flow in the direction of the first passage may be formed.

According to the present invention, there is provided a system for treating brain diseases in which long-term drainage is possible and both drug administration and cerebrospinal fluid drainage are possible.

1 is a schematic diagram of a brain disease treatment system according to an embodiment of the present invention,
2 is a control diagram of a brain disease treatment system according to an embodiment of the present invention,
3 is a cut-away view of a two-way flow control valve in the brain disease treatment system according to an embodiment of the present invention,
4 is an exploded view of a two-way flow control valve in the brain disease treatment system according to an embodiment of the present invention,
5 is an enlarged view of a flow controller in a two-way flow control valve in a brain disease treatment system according to an embodiment of the present invention,
6 shows a modified example of the flow control body in the bidirectional flow control valve in the brain disease treatment system according to an embodiment of the present invention,
7 shows the operation of the flow control unit in the two-way flow control valve in the brain disease treatment system according to an embodiment of the present invention,
8 shows an example of a modified use of the brain disease treatment system according to an embodiment of the present invention.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. However, this embodiment is not limited to the embodiments disclosed below, but may be implemented in various forms, only this embodiment makes the disclosure of the present invention complete, and the scope of the invention is given to those of ordinary skill in the art. It is provided to be fully informed. The shapes of elements in the drawings may be exaggerated for a more clear explanation, and elements indicated by the same reference numerals in the drawings mean the same elements.

A brain disease treatment system according to an embodiment of the present invention will be described with reference to FIGS. 1 and 2.

The brain disease treatment system 1 according to an embodiment of the present invention includes an internal device 10 located in the skull of a patient and an extracorporeal device 20 located outside the skull of the patient.

The internal device 10 is also called a chemopot (or brain port), and is implanted in the patient's head to inject drugs. The internal device 10 according to the present invention includes a two-way flow control valve 11 shown in FIG. 3, and when the brain pressure exceeds a certain pressure by the two-way flow control valve 11, the cerebrospinal fluid is drained to the external device 20. , During administration, the drug flows from the extracorporeal device 20 to the ventricle. Details of the bidirectional flow control valve 11 will be described later.

The external device 20 includes a drainage container 210, a drug injection unit 220, a connection unit 230, and a control unit 240.

The drainage container 210 is also called a drainage bag, and accommodates cerebrospinal fluid to be drained. Since the drainage container 210 has a constant pressure, it is possible to change or control the brain pressure when the bidirectional flow control valve 11 is opened toward the extracorporeal device 20. This is the use of the sum of the cracking pressure (a fixed value determined by the mechanical characteristics of the valve) and the internal pressure of the drain container 210 when the bidirectional flow control valve 11 is opened. Pressure control of the drain container 210 may be performed in a conventional manner.

The drug injection unit 220 includes a drug storage unit 221 and a drug pump 222. The drug storage unit 221 may be made of plastic, vinyl and/or metal, and the drug pump 222 allows the drug to be supplied to the ventricle at a constant flow rate.

The connection part 230 includes a fluid line 231, a pressure gauge 232, a flow meter 233, and a flow path converter 234.

The pressure gauge 232 (pressure sensor) measures the pressure of the fluid line 231, that is, the pressure of the input terminal of the internal device 10. The pressure gauge 232 measures pressure at all times or at regular time intervals, and may measure pressure at irregular intervals or at a separate user request. The measured pressure value is used to convert brain pressure during administration.

The flow meter 233 measures the flow rate input to the internal device 10 at the time of administration, and the measured flow rate value is used to convert the brain pressure at the time of administration.

The flow path changer 234 performs a function of changing the connection state of the flow path by an electric signal or the like, and may use a solenoid valve. The flow path converter 234 connects the internal device 10 to the drug injection unit 220 when administering, and connects the internal device 10 to the drain container 210 when draining.

The control unit 240 receives measured values from the pressure gauge 232 and the flow meter 233 and controls the flow path converter 234 and the drug injection unit 220 based on this. In addition to this, the control unit 240 may perform control by receiving an external instruction from a patient or medical staff. External instructions can be received via wired or wireless.

The pressure (brain pressure) in the ventricle and the pressure, flow rate, etc. at the input end of the internal device 10 have a certain functional relationship due to the mechanical properties of the two-way control valve 11 located in the internal device 10. The control unit 240 converts the brain pressure using a functional relationship from the pressure value and the flow rate value measured at the time of administration. When the brain pressure exceeds a certain value, the controller 240 controls the flow path converter 234 to change and drain the flow path.

In the above drawings and description, a power supply for power supply is omitted. The power supply unit may use an external power source or use a battery.

Hereinafter, a bidirectional flow control valve in the present invention will be described with reference to FIGS. 3 to 5.

3 is a cutaway view of a bidirectional flow control valve according to an embodiment of the present invention, FIG. 4 is an exploded view of a bidirectional flow control valve according to an embodiment of the present invention, and FIG. This is an enlarged view of the flow control body of the bidirectional flow control valve. In FIG. 5, a cross-sectional view along A-A' is also shown.

As shown in FIG. 3, the bidirectional flow control valve 11 includes a valve body 1100 and a flow control unit 1200, and the flow control unit 1200 includes a first flow control body 1210 and a second flow control. It includes a sieve 1220, a first pressing member 1230, a second pressing member 1240, a stopper 1250, and supporting portions 1262 and 1264.

As shown in FIGS. 3 and 4, the valve body 1100 forms a flow path through which fluid can move, and the direction of the flow path can be divided into a first flow path direction and a second flow path direction according to the fluid flow. .

In the present invention, the fluid flow flowing from the second flow control body 1220 to the first flow control body 1210 is in the direction of the first flow path, and conversely, from the first flow control body 1210 to the second flow control body 1220 The directed fluid flow is defined as the second flow path direction.

The valve body 1100 has a circular cross section, but may have a trapezoidal or rectangular shape in other embodiments. In this case, the shape of the flow control unit 1200 may also be changed.

The flow control unit 1200 is configured to control bidirectional flow control in the valve body 1100, and the flow control unit 1200 is driven to determine the closing, opening and opening directions of the flow path in the valve body 1100. This is done. The operation of the flow control unit 1200 will be described in detail in the operation of the flow control unit of the bidirectional flow control valve according to an embodiment of the present invention in FIG. 7.

The first flow control body 1210 and the second flow control body 1220 are movable in the flow path direction within the valve body 1100 and face each other. The outer circumferential surfaces of the first flow control body 1210 and the second flow control body 1220 may be in close contact with the inner circumferential surface so as not to allow fluid flow of the valve body 1100.

A first through hole 1212 is formed in the first flow control body 1210 to expose the second flow control body 1220. In a state in which both flow control bodies 1210 and 1220 are in close contact with each other through the first through hole 1212, the fluid flow moving in the direction of the second flow path and a part of the second flow control body 1220 directly contact each other.

The second flow control body 1220 has a second through hole 1222 that does not communicate with the first through hole 1212. In a state in which both flow control bodies 1210 and 1220 are in close contact with each other through the second through hole 1222, the fluid flow moving in the direction of the first flow path and a part of the first flow control body 1210 directly contact each other.

In this embodiment, one through hole is formed in the center of the first flow control body 1210 and a plurality of through holes are formed around the second flow control body 1220, but in other embodiments, the size, shape, location, and The number can be varied in various ways.

The first flow control body 1210 and the second flow control body 1220 contact each other when no fluid flow occurs in the valve body 1100 to close the flow path, and when a fluid flow above a certain level occurs in the flow path, The first flow control body 1210 and the second flow control body 1220 are spaced apart from each other to open the flow path.

3 and 4, the first pressing member 1230 provides a pressing force to the first flow control body 1210 in the direction of the second flow control body 1220, and the second pressing member 1240 Is to provide a pressing force to the second flow control body 1220 in the direction of the first flow control body 1210.

In one embodiment of the present invention, the first pressing member 1230 and the second pressing member 1240 are made of a spring, and in another embodiment, a configuration capable of providing pressing force, for example, rubber, may be used.

As shown in Figure 4, the stopper 1250 is coupled to the valve body 1100, is located between the first flow control body 1210 and the second flow control body 1220, the first flow control body ( 1210) and the second flow control body 1220 are in close contact with the first flow control body 1210 and the second flow control body 1220. In another embodiment, a part of the stopper 1250 is movable within the valve body 1100, or the stopper 1250 does not contact the flow control bodies 1210 and 1220 in a close contact with the flow control bodies 1210 and 1220. May not.

In a state in which the first flow control body 1210 and the second flow control body 1220 are in close contact as in this embodiment, the stopper 1250 is connected to the first flow control body 1210 and the second flow control body 1220. When in direct contact, the sealing state may be improved in a close contact state by contacting the flow control bodies 1210 and 1220 and the stopper 1250.

The stopper 1250 limits the movement of the first flow control body 1210 in the direction of the second flow path, and restricts the movement of the second flow control body 1220 in the direction of the first flow path.

The stopper 1250 may have any shape as long as the movement of the first flow control body 1210 and the second flow control body 1220 is limited without significantly interfering with the flow of fluid in both directions in the valve body 1100. It is possible.

In one embodiment of the present invention, it is shown that the stopper 1250 is coupled to the valve body 1100 and does not move in any direction within the valve body 1100, but in another embodiment, according to the fluid flow in the valve body 1100 It may be possible to move slightly.

The support portions 1262 and 1264 serve to support the first pressing member 1230 and the second pressing member 1240 from being separated from the inside of the valve body 1100, and the first flow path of the first pressing member 1230 A first support portion 1262 restricting movement in the direction and a second support portion 1264 restricting movement of the second pressing member 1240 in the direction of the second passage.

The first support portion 1262 and the second support portion 1264 are fixed to the valve body 1100.

The first pressing member 1230 is located between the first support portion 1262 and the first flow control body 1210, and the second pressing member 1240 includes a second support portion 1264 and a second flow control body 1220. ).

In one embodiment of the present invention, the support portions 1262 and 1264 are formed in a form in which three bars are overlapped, but in other embodiments, they may be provided in various forms such as a grid and a cross.

The support portions 1262 and 1264 are configured to limit movement of the first pressurizing member 1230 and the second pressurizing member 1240 in the valve body 1100 according to a bidirectional fluid flow, and the first support 1262 is a first It is in contact with the pressing member 1230, and the second support part 1264 is in contact with the second pressing member 1240.

One of the flow control bodies 1210 and 1220 may be made of a relatively soft material and the other may be made of a hard material in order to improve the sealing force in the close contact state. In another embodiment, a buffer member (not shown) for preventing the flow control bodies 1210 and 1220 made of hard material from being damaged by the pressing members 1230 and 1240 may be further included.

The buffer member (though not shown) may be located between the first pressing member 1230 and the first flow control body 1210, and between the second pressing member 1240 and the second flow control body 1220 You may.

The buffer member (although not shown) is made of a material that serves as a buffer between the flow control body and the pressure member made of a hard material, for example, rubber such as silicone rubber may be used.

In the present invention, the shapes of the flow control bodies 1210 and 1220 may be variously modified, which will be described with reference to FIG. 6.

6 shows a modified example of the flow control body in the bidirectional flow control valve according to an embodiment of the present invention. 6 is a cross-sectional view along B-B'.

The first flow control body 1210 has a disk shape and the second flow control body 1220 has a spherical shape.

In another embodiment, the shapes of the first flow control body 1210 and the second flow control body 1220 may be variously changed.

With reference to Figure 7 will be described with respect to the operation of the bidirectional flow control valve flow control unit according to an embodiment of the present invention.

7 illustrates the operation of a flow control unit of a bidirectional flow control valve according to an embodiment of the present invention.

As shown in Figure 7, the first flow control body 1210 and the second flow control body 1220 does not generate a fluid flow in the valve body 1100 or a fluid flow (fluid pressure) below a certain level occurs. In this case, the flow path is closed by contacting each other, and when a fluid flow (fluid pressure) above a certain level occurs in the flow path, the first flow control body 1210 and the second flow control body 1220 are spaced apart from each other to open the flow path. .

In the closed state where no fluid flow occurs in the flow path as shown in (a), the flow control bodies 1210 and 1220 and the pressure members 1230 and 1240 of the flow control unit 1200 do not move inside the valve body 1100. Stay in the state.

In particular, the first flow control body 1210 and the second flow control body 1220 have the stopper 1250 in the center by the pressing members 1230 and 1240 applying a pressing force, and are in close contact with each other. This close contact state is maintained only when a fluid flow (fluid pressure) such that the pressure members 1230 and 1240 cannot be deformed occurs.

Thereafter, as shown in (b), when a fluid flow above a certain level occurs in the direction of the first channel, the fluid flow in the direction of the first channel through the second through hole 1222 formed in the second flow control body 1220 and A part of the first flow control body 1210 comes into direct contact.

At this time, the first pressurizing member 1230 that provided the pressing force to the first flow controller 1210 in the direction of the second flow controller 1220 is reduced and deformed, so that the first flow controller 1210 moves in the direction of the first flow path. It moves and is spaced apart from the second flow control body 1220 to open the flow path through both through holes 1212 and 1222. Here, the movement of the first pressing member 1230 is restricted by the first support portion 1262, and the movement of the second flow control body 1220 is restricted by the stopper.

Thereafter, as shown in (c), when a certain level of fluid flow occurs in the direction of the second flow path, the fluid flow and control in the direction of the second flow path through the first through hole 1212 formed in the first flow control body 1210. 2 Part of the flow control body 1220 comes into direct contact.

At this time, the second pressurizing member 1230 that provided the pressing force to the second flow controller 1220 in the direction of the first flow controller 1210 is deformed, and the second flow controller 1220 moves in the direction of the second flow path. Thus, while being spaced apart from the first flow controller 1220, the flow path through both through holes 1212 and 1222 is opened. Here, the movement of the second pressing member 1240 is restricted by the second support portion 1264, and the movement of the first flow control body 1210 is restricted by the stopper.

In the bidirectional flow control, the first flow control body 1210 and the second flow control body 1220, which were limited in motion by the pressing members 1262 and 1264, are pressurized members according to different fluid flows (bidirectional fluid flows). As 1262 and 1264 are deformed, the flow path in the valve body 1100 is opened by moving in the direction of the first flow passage or the direction of the second flow passage.

The flow path opening pressure (flow path) is made possible by adjusting the elasticity of the pressing members 1230 and 1240 and the area and shape of the through holes 1212 and 1222 formed in the flow control bodies 1210 and 1220.

The two-way flow control valve according to the present invention enables two-way flow control only by using a single valve, and the effect of miniaturization and simplification occurs due to the use of a single valve.

The operation of the brain disease treatment system 1 according to the present invention described above will be described.

When a drug injection is required according to an instruction from the outside, the controller 240 controls the flow path switch 234 to connect the internal device 10 and the drug injection unit 220 to inject the drug. The two-way control valve 11 forms a flow path in the direction of the second flow path (ventricular direction) by the pressure caused by the drug injection, so that the drug is injected into the ventricle.

Then, when it is determined that the brain pressure calculated from the measured pressure and flow rate exceeds a certain level, the controller 240 controls the flow path switch 234 to connect the internal device 10 and the drainage container 210. The bidirectional control valve 11 forms a flow path in the direction of the first flow path (outside) by the brain pressure, so that the cerebrospinal fluid is discharged into the drainage container 210.

According to the present invention described above, administration and long-term drainage are possible by using the internal device 10 having an allowable pressure in both directions and the drainage container 210 capable of adjusting the internal pressure. In addition, it is possible to perform drug injection and drainage through a single implantation operation of the internal body device 10 without the complicated procedure required by ventricular-laparoscopic shunting, and measurement of brain pressure can be repeatedly performed for a long time.

A modified use example of the brain disease treatment system according to an embodiment of the present invention will be described with reference to FIG. 8.

When drug treatment is no longer required, all except for the fluid line 231 and the drainage container 210 from the external device 20 as shown in FIG. 8 may be removed. Since the internal device 10 has a two-way flow control valve 11 that allows external flow only when a certain pressure is exceeded during long-term drainage, long-term drainage is possible with only a simple configuration.

Embodiments of the present invention described above and shown in the drawings should not be construed as limiting the technical idea of the present invention. The protection scope of the present invention is limited only by the matters described in the claims, and those of ordinary skill in the technical field of the present invention can improve and change the technical idea of the present invention in various forms. Therefore, such improvements and changes will fall within the scope of protection of the present invention as long as it is apparent to those of ordinary skill in the art.

Claims (11)

In the brain disease treatment system,
An internal device implanted into the patient's skull and including a two-way flow control valve; And
It is located outside the skull of the patient, and includes an extracorporeal device for supplying drugs to the internal device or discharging cerebrospinal fluid from the internal device,
The extracorporeal device,
Drug injection unit including a pump;
Drainage container for storing cerebrospinal fluid discharged from the body;
A connection part connecting the internal device to the drug injection part and the drainage container; And
And a control unit for controlling the operation of the connection unit,
The bidirectional flow control valve,
A valve body forming a flow path through which fluid moves;
It includes a flow control unit located in the valve body,
The flow control unit,
A first flow control body and a second flow control body that are movable in the flow direction and face each other;
A first pressing member for providing a pressing force to the first flow controller in the direction of the second flow controller;
And a second pressing member for providing a pressing force to the second flow control body in a direction of the first flow control body,
In a state in which the first flow control body and the second flow control body are in close contact,
A part of the first flow control body directly contacts the fluid flow in the direction of the first flow path from the second flow control body toward the first flow control body,
A brain disease treatment system in which a part of the second flow control body directly contacts the fluid flow in a second flow path direction opposite to the first direction. delete The method of claim 1,
The connection part,
A fluid line connecting the internal device to the drug injection unit and the drain container; And
It is located on the fluid line, and includes a flow path switch for selectively connecting the internal device to the drug injection unit and the drain container,
The control unit is a brain disease treatment system for controlling the operation of the flow path switch. The method of claim 3,
The connection part,
A flow meter measuring the flow rate of the fluid line; And
Further comprising a pressure gauge for measuring the pressure of the fluid line,
The control unit is a brain disease treatment system for controlling the operation of the flow path switch based on the measurement result of the flow meter and the pressure meter. The method of claim 4,
The control unit calculates the brain pressure from the measurement results of the flow meter and the pressure meter,
When the calculated brain pressure exceeds a certain value, the body device is connected to the drainage container to control the operation of the flow path switch so that cerebrospinal fluid is discharged. The method of claim 3,
The brain disease treatment system in which the drainage container is pressurized at a predetermined pressure. The method of claim 1,
The first flow control body and the second flow control body contact to close the flow path,
When a fluid flow above a certain level occurs in the flow path,
The brain disease treatment system, characterized in that the first flow control body and the second flow control body are spaced apart from each other to open the flow path. In claim 1,
The first pressing member and the second pressing member are made of an elastic body having an elastic force,
When a fluid flow of more than a certain level occurs in the direction of the first flow path, the first pressure member is deformed and the first flow controller moves in the direction of the first flow path to open the flow path,
A brain disease treatment system, characterized in that when a fluid flow of more than a certain level occurs in the direction of the second channel, the second pressure member is deformed and the second flow controller moves in the direction of the second channel to open the channel . In claim 1,
The flow control unit,
Further comprising a stopper positioned between the first flow control body and the second flow control body,
The stopper,
Limiting the movement of the first flow control body in the direction of the second flow path,
Brain disease treatment system, characterized in that limiting the movement of the second flow controller in the direction of the first flow path. In claim 1,
The flow control unit,
Further comprising a support for limiting the movement of the pressing member,
The support part,
A first support portion for restricting movement of the first pressing member in the direction of the first passage;
A brain disease treatment system comprising a second support for limiting the movement of the second pressing member in the direction of the second passage. In claim 1,
The first flow control body has a first through hole for exposing the second flow control body to the fluid flow in the direction of the second flow path,
The brain disease treatment system, wherein the second flow control body has a second through hole that does not communicate with the first through hole and exposes the first flow control body to the fluid flow in the direction of the first flow path.

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