KR101961415B1 - Tubeless implantable drug infusion system - Google Patents

Abstract

The present invention relates to a body-insertable tubeless drug infusion system in which a reservoir, a pump, and an external connection part are connected in a modular form without a tube to minimize a drug movement space, the system comprising: a lower cover having a top surface opened to define a first accommodation space; A lower cover opened to define a second storage space; A drug reservoir inserted into the first containing space and storing the drug; A pump disposed in the second compartment to provide power to release the drug stored in the drug reservoir through the discharge port into the body; A control unit disposed in the second accommodation space and controlling a drug release amount through the pump; And an intermediate cover that separates the first receiving space and the second receiving space and has a connection module including a first path between the drug reservoir and the pump and a second path between the pump and the emitting port.

Description

[0001] TUBELESS IMPLANTABLE DRUG INFUSION SYSTEM [0002]

The present invention relates to an implantable tubular drug infusion system, and more particularly, to a transplantable tubular drug infusion system having a reservoir, a pump, and an external connection unit, .

Generally, as shown in FIGS. 1A and 1B, the implantable drug infusion system includes a storage inlet 11 for replenishing the drug in the drug reservoir 20, a catheter port for draining the drug, A system housing 10 having a catheter 12 and a catheter access port 13 for preventing air ingress during drug outflow, a drug reservoir 20 for storing a drug, A pump 30 for transferring the drug to the catheter port 12, a control board 40 for controlling the pump 30 and a battery 50 for supplying power to the pump 30 and the control board 40. [ .

Of these, the most important component is the pump 30 for injecting the drug into the body in a predetermined amount. In the conventional implantable drug injection system, various types of electric or mechanical pumps 30 have been used, A pump 30 of a general type is a peristaltic pump in which a roller pushes a drug. At this time, the drug delivery pump 30 must slowly inject a small amount of drug into the body for a very long period of time in an extremely accurate amount, and it is also necessary to prevent backflow phenomenon in which the drug is backwarded toward the drug pump .

However, in the body-insertable drug infusion system as described above, a plurality of components such as the catheter port 12, the catheter access port 13, the drug reservoir 20, the pump 30, Therefore, it is difficult to miniaturize the system, since each component is connected using a tube, and a space for a tube, which is a path for drug delivery, must be secured.

In addition, in the case of the peristaltic pump as described above, there is a problem that the drug backflow phenomenon occurs due to the change of the tube volume at the time of returning to the original state after the contraction of the tube which is the path of drug delivery after the roller pushes out the drug .

In particular, in the case of an implantable tubeless drug delivery system that injects several milliliters (ml) per day, several milliliters (μl) of liquid is transferred during one injection. In the case of a peristaltic counterflow The use of drugs such as morphine has a problem that it can act as a very dangerous factor to the human body.

SUMMARY OF THE INVENTION The present invention has been made in order to solve the above problems of the prior art, and it is an object of the present invention to provide a drug delivery system which is capable of delivering a drug without providing a separate tube for connecting the components, Lt; / RTI > drug injection system.

In addition, the present invention prevents the occurrence of a backflow phenomenon by installing an NC (Normally Closed) type valve in a drug injection port and an outlet valve without using a tube in which a reverse flow phenomenon may occur in controlling the drug discharge amount Lt; RTI ID = 0.0 > tubular < / RTI > drug injection system.

In order to accomplish the above object, the present invention provides a system for injecting a tubular drug into a body, the system comprising: a lower cover having a top surface opened to define a first containing space; A lower cover opened to define a second storage space; A drug reservoir inserted into the first containing space and storing the drug; A pump disposed in the second compartment to provide power to release the drug stored in the drug reservoir through the discharge port into the body; A control unit disposed in the second accommodation space and controlling a drug release amount through the pump; And an intermediate cover that separates the first receiving space and the second receiving space and has a connection module including a first path between the drug reservoir and the pump and a second path between the pump and the emitting port.

Here, the upper cover may include a priming hole for receiving the liquid for preventing air intrusion, and the connection module may include a priming port for injecting the liquid supplied through the priming hole on the second path.

The case may further include a case on which the lower cover is seated and on which the upper cover is exposed, and an anchor that is in close contact with the body tissue may be formed on a lower side of the case.

The pump includes a micro-diaphragm chamber to which the drug is charged; A micro-solenoid injection valve for opening a path between the injection port connected to the first path by the first control signal and the micro-diaphragm chamber; A micro-solenoid outlet valve for opening a path between the micro-diaphragm chamber and an outlet connected to the second path by a second control signal; And a pressure regulator for applying pressure to the diaphragm of the micro-diaphragm chamber to discharge a predetermined amount of the drug through the outlet, wherein the controller generates the first control signal for drug charging, Signal to the micro-solenoid injection valve, generate the second control signal for drug discharge, and output the generated second control signal to the micro-solenoid discharge valve.

In addition, the micro solenoid injection valve and the micro solenoid outflow valve may be normally closed valves.

The pressure regulator may include a spring for applying an elastic force to the diaphragm.

In addition, the pressure regulator may include a propellant gas that pressurizes the diaphragm.

Meanwhile, the first control signal and the second control signal are voltages applied by the control unit, and the controller adjusts a first opening time for applying the first control signal, Can be adjusted.

In addition, the controller may adjust the discharge amount of the drug by adjusting a second opening time for applying the second control signal.

The control unit may further include a communication module for receiving a signal for determining the lengths of the first opening time and the second opening time.

The present invention provides a drug delivery path that is modularized between the components to which the drug is delivered in the drug infusion system, so that a separate tube used as a drug delivery path can be omitted, thereby enabling miniaturization of the system, There is an effect that inconvenience can be reduced when transplanting into the body.

In addition, unlike the conventional implantable drug injection system, the present invention does not use a tube that may cause a backflow phenomenon in controlling the drug discharge amount. Therefore, it is possible to prevent the backflow of the drug due to the volume change of the tube, The injection port and the outlet valve are equipped with the NC type valve, thereby preventing the drug from flowing out even when the supply of electricity is interrupted.

FIGS. 1A and 1B show a conventional implantable drug infusion system.
FIG. 2 illustrates a structure of an implantable tubular drug infusion system according to an embodiment of the present invention. Referring to FIG.
FIG. 3 is a block diagram illustrating a body-insertable tubeless drug infusion system according to an embodiment of the present invention.
4 is a view showing another embodiment of a pump in a body-insertable tubeless drug infusion system according to an embodiment of the present invention.
FIGS. 5A to 5D are diagrams illustrating a pump structure of a body-insertable tubeless drug injection system according to an embodiment of the present invention.
6 is a flowchart illustrating a pumping operation of a body-insertable tubeless drug infusion system according to an embodiment of the present invention.
FIGS. 7A through 7E are diagrams illustrating pumping operations of an implantable tubular drug infusion system according to an embodiment of the present invention.

Hereinafter, preferred embodiments of the present invention will be described with reference to the accompanying drawings. However, the embodiments of the present invention can be modified into various other forms, and the scope of the present invention is not limited to the embodiments described below. The shape and the size of the elements in the drawings may be exaggerated for clarity and the same elements are denoted by the same reference numerals in the drawings.

And throughout the specification, when a part is referred to as being "connected" to another part, it includes not only "directly connected" but also "electrically connected" with another part in between. Furthermore, when a component is referred to as being "comprising" or "comprising", it is to be understood that this does not exclude other components, do.

Furthermore, the terms "first "," second ", and the like are used to distinguish one element from another element, and the scope of the right should not be limited by these terms. For example, the first component may be referred to as a second component, and similarly, the second component may also be referred to as a first component.

FIG. 2 is a view showing a system for injecting a tubular drug into a body cavity according to an embodiment of the present invention, and FIG. 3 is a block diagram showing a system for injecting a tubular drug into a body cavity according to an embodiment of the present invention. 4 is a view showing another embodiment of the pump 100 in the body-insertable tubeless drug injection system according to the embodiment of the present invention, and FIGS. 5A to 5D are cross- FIG. 2 is a view illustrating a structure of a pump 100 according to an embodiment of the present invention. FIG. 2 is a schematic view illustrating a structure of a pump 100 according to an embodiment of the present invention. 300, an upper cover 400, an intermediate cover 500, a control unit 600, a case 700, and a power supply unit 800.

The pump 100 is disposed in a second containment space formed between the upper cover 400 and the intermediate cover 500 and is injected into the body in a very small amount, such as a drug, e.g., morphine, stored in the drug reservoir 300 Lt; / RTI > drug into the body. 3, the pump 100 includes a micro-diaphragm chamber 110, a micro-solenoid injection valve 120, a micro-solenoid discharge valve 130, and a pressure regulating unit 130, as shown in FIG. (140).

Here, the micro-diaphragm chamber 110 is filled with the drug for injecting into the patient's body through the injection port 121 connected to the first path, and is charged according to the pressure applied to the diaphragm by the pressure regulator 140 And the drug is discharged through the outlet 131 connected to the second path. Here, the micro-diaphragm chamber 110 may be a silicon material having a thickness of about 200 탆, but is not limited thereto.

The micro solenoid injection valve 120 receives a first control signal corresponding to a voltage for activation, for example, a DC voltage of about 5 V, from the control unit 600, And opens the path between the micro-membrane chamber (121) and the micro-diaphragm chamber (110). Here, the micro solenoid injection valve 120 is a normally closed (Normally Closed) valve. The material of the path between the injection port 121 and the micro diaphragm chamber 110 constituting the micro solenoid injection valve 120 is But is not limited to, a material excellent in chemical resistance to liquids such as perfluoroelastomer, PEEK (Polyether Ether Ketone) and the like. On the other hand, the injection port 121 is preferably a cylindrical path having a diameter of about 400 mu m, but is not limited thereto.

On the other hand, the micro solenoid outflow valve 130 receives a second control signal corresponding to a voltage for activation, for example, a DC voltage of about 5 V, from the control unit 600, And opens the path between the micro-membrane chamber (131) and the micro-diaphragm chamber (110). Here, the micro solenoid outflow valve 130 is a normally closed type valve such as a micro solenoid injection valve 120, and a path between the outlet 131 constituting the micro solenoid outflow valve 130 and the micro diaphragm chamber 110 Is preferably a material having excellent chemical resistance to a liquid such as a perfluoroelastomer or PEEK, but is not limited thereto. On the other hand, the outlet 131 is preferably a cylindrical path having a diameter of about 400 mu m, but is not limited thereto.

In addition, the pressure regulator 140 applies pressure to the diaphragm of the micro-diaphragm chamber 110 so that a predetermined amount of drug is discharged through the outlet port 131. Here, the pressure regulator 140 may be a spring 141 that applies an elastic force to the diaphragm, or a propellant gas that is filled in the predetermined space 142 to apply pressure to the diaphragm. On the other hand, the propellant gas acting as the pressure regulator 140 is preferably a substance which is present in a liquid state at room temperature, such as isopentane, and is vaporized at about 37.5 ° C. But is not limited thereto. Further, in order to prevent leakage of the propellant gas, the housing of the space 142 for containing the propellant gas should be sealed by means of water-repellent pressing, laser welding, or the like.

3, in which case the pump 100 is connected to both the membrane 190 and the membrane 190 on both sides of the membrane 190. The pump 100 may be an electroosmotic pump as shown in Figure 4 as well as the solenoid pump shown in Figure 3, The first electrode 170 and the second electrode 180 are connected to the control unit 600. The first electrode 170 and the second electrode 180 are provided to the control unit 600 and the control unit 600, respectively.

The first electrode 170 and the second electrode 180 are respectively disposed to contact the inlet 150 connected to the first movement path and the outlet 160 connected to the second movement path and may be made of porous carbon. In addition, the first electrode 170 and the second electrode 180 are maintained at a constant spacing therebetween by the membrane 190, as shown in FIG. 4, and can be made of a porous material or structure .

The first electrode 170 and the second electrode 180 are supplied with electric power from the controller 600 and cause an electrochemical reaction as the ions move. At this time, the controller 600 can switch the polarities of the voltages supplied to the first electrode 170 and the second electrode 180 at predetermined time intervals and apply them.

The membrane 190 is installed between the inlet 150 connected to the first movement path, which is the movement path of the drug, and the outlet 160 connected to the second movement path, and is formed of a porous material or structure to allow movement of the drug .

That is, when a voltage difference is generated between the first electrode 170 and the second electrode 180 by the controller 600, the redox reaction occurs and ions are moved to provide a pumping force to move the drug.

The lower cover 200 may have a bottom surface and a side surface, and the top surface may be opened to define the first storage space, and the drug storage space 300 may be seated inside the first storage space. The lower cover 200 also includes a hole through which the modular pipe 511 forming the second movement path for connecting between the pump 100 and the discharge port 710 can pass, 210 may be formed. At this time, the lower cover 200 may be made of a material using stainless steel or titanium alloy excellent in biocompatibility.

The drug reservoir 300 is inserted into the first containing space in the lower cover 200 and stores the drug and when the first control signal is applied from the control unit 600 to the micro solenoid injection valve 120, Is injected into the micro diaphragm chamber 110 through the first hole 320 and the injection port 121. At this time, the drug reservoir 300 is preferably, but not limited to, a capacity capable of storing the amount of drug that can be administered to the patient for about six months. On the other hand, the drug reservoir 300 may be a structure having a storage injection port 310 and allowing a user to replenish the drug through a syringe, but is not limited thereto. Also, the drug reservoir 300 may be made of a material using stainless steel or titanium alloy excellent in biocompatibility.

The upper cover 400 has a top surface and a side surface and the bottom surface is opened to define the second storage space and the pump 100, the control unit 600, and the power supply unit 800 are disposed in the second storage space . The upper cover 400 includes a second hole 410 for receiving a drug through the storage injection port 310 of the drug reservoir 300 and is provided with a priming hole 420 may be provided. The upper cover 400 may be made of a material using stainless steel or titanium alloy excellent in biocompatibility.

The intermediate cover 500 is disposed between the lower cover 200 and the upper cover 400 to separate the first storage space from the second storage space and to separate the first path between the drug reservoir 300 and the pump 100 A connection module 510 including a second path between the pump 100 and the discharge port 710 is formed. At this time, the intermediate cover 500 may be provided with an injection path 520 for connecting the second hole 410 of the upper cover 400 and the storage injection port 310 of the drug reservoir 300. The intermediate cover 500 may be made of a material using stainless steel or titanium alloy excellent in biocompatibility.

Here, the connection module 510 has an inlet that is matched with the first hole 320 of the drug reservoir 300 disposed in the first receiving space, and has an outlet matched with the inlet 121 of the pump 100 1 path is formed. The connection module 510 also has a second path with an inlet matched to the outlet 131 of the pump 100 and having an outlet matched to the drug release path of the discharge port 710. At this time, the connection module 510 is formed in the second receiving space for connection with the pump 100, and the pump 100 and the screw 100 are used for pressing the pump 100 and the first and second paths Can be combined. In addition, in order to compress the connection module 510 and the pump 100, a portion of the pump 100 contacting the inlet 121 of the pump 100 and a portion of the pump 100 contacting the outlet 131 of the pump 100 Or the connection module 510 and the pump 100 may be bonded using an epoxy material.

In addition, the connection module 510 may include a priming port 512 formed on the second path so that the liquid supplied through the priming hole 420 can be injected.

The control unit 600 generates a first control signal for charging the drug in the micro diaphragm chamber 110 and outputs the generated first control signal to the micro-solenoid injection valve 120. The micro-diaphragm chamber 110 And outputs the generated second control signal to the micro-solenoid discharge valve 130. The micro-solenoid discharge valve 130 is connected to the micro- Here, the first control signal and the second control signal generated by the controller 600 may be a voltage applied for activation of the micro-solenoid injection valve 120 and the micro-solenoid valve 130, for example, Lt; / RTI > At this time, the control unit 600 may adjust the time for which the voltage is applied to the micro solenoid injection valve 120 and the micro solenoid outflow valve 130 and the time for which the voltage is not applied, so that the drug can be safely supplied to the body. The control unit 600 includes a communication module (not shown) for supporting frequency communication or Bluetooth communication of about 402 to 405 MHz according to the communication standard of MICS (Medical Implant Communication Service) It is possible to receive from the external control device a signal for setting the time for which the voltage is applied to the injection valve 120 and the micro solenoid outflow valve 130 and the length of the unused time.

The case 700 is formed as an upper open housing in which the lower cover 200 is seated and the upper cover 400 is exposed and an anchor 720 is formed at the lower side to be in close contact with the body tissue. In addition, the case 700 includes a discharge port 710 on the side thereof, and the discharge port 710 is a path for injecting the drug discharged through the discharge port 131 into the body. At this time, if the second movement path connected to the discharge port 710 at the time of first drug injection is filled with air, air can be injected into the body. Therefore, liquid such as saline solution is filled into the second movement path through the priming port 512 , And the risk of air being injected into the body by injecting drugs can be prevented.

A portion of the case 700 excluding the discharge port 710 is formed of polycarbonate (PC) or the like, which is advantageous for forming the anchor 720, and the discharge port 710 through which the drug is conducted is biocompatible It can be made of a material made of excellent stainless steel or titanium alloy.

On the other hand, the power supply unit 800 supplies power to the control unit 600. Here, the power supply unit 800 may be a lithium battery having a hybrid cathode suitable for implantation in the body.

FIG. 6 is a flow chart illustrating the operation of the intra-body implantable tubular drug infusion system according to an embodiment of the present invention. FIGS. 7A to 7E are views showing the operation of the intravenous infusionless tubular drug infusion system according to an embodiment of the present invention Referring to FIGS. 6 to 7E, an operation of the injectable tubular drug injection system according to an embodiment of the present invention will be described as follows.

First, the control unit 600 applies a first control signal to the microsolenoid injection valve 120 during an opening solenoid opening time of the microsolenine injection valve 120, Is charged in the micro-diaphragm chamber 110 (S100).

7A, before the first control signal is applied to the micro-solenoid injection valve 120, the path between the inlet 121 and the micro-diaphragm chamber 110 is closed and the micro-diaphragm chamber 110 is closed, The drug is not charged. 7B, when a first control signal is applied to the micro-solenoid injection valve 120, the path between the injection port 121 and the micro-diaphragm chamber 110 is opened to allow the drug to flow into the micro-diaphragm chamber 110, . At this time, since the control unit 600 does not apply the second control signal to the micro solenoid outflow valve 130, the path between the outlet 131 and the micro diaphragm chamber 110 is closed as shown in FIG. 7B The drug in the micro-diaphragm chamber 110 can be charged. In order to charge the drug in the micro diaphragm chamber 110, the control unit 600 applies the first control signal for about 1 second to about 3 seconds, The time for applying the control signal can be adjusted, and the controller 600 can constantly charge a predetermined amount of the drug in the micro diaphragm chamber 110 through the adjustment of the application time.

Thereafter, the control unit 600 terminates the application of the first control signal to the micro solenoid injection valve 120, and transmits the second control signal to the micro solenoid outflow valve 130 during a predetermined middle delay time The signal is not applied so that the drug filled in the micro-diaphragm chamber 110 can be stabilized (S200).

7C, the path between the inlet 121 and the micro diaphragm chamber 110 and the path between the outlet 131 and the micro diaphragm chamber 110 are closed so that the pump 100 is connected to the micro diaphragm chamber 110, So that the drug is kept charged.

Next, the controller 600 applies a second control signal to the micro-solenoid valve 130 during the opening solenoid opening time of the micro-solenoid valve 130, (S300) so that the drug packed therein is discharged through the outlet port (131).

7D, the path between the inlet 121 and the micro-diaphragm chamber 110 is closed so that the drug is not charged into the micro-diaphragm chamber 110, The drug filled in the micro diaphragm chamber 110 is discharged through the outlet 131 by the restoring elastic force of the spring 141 of the pressure regulator 140 applied to the diaphragm of the micro diaphragm chamber 110 by opening the path.

On the other hand, the time for the control unit 600 to apply the second control signal for discharging the drug in the micro-diaphragm chamber 110 is about several tens of microseconds, and the second control signal is applied in accordance with the amount of drug to be administered at one time And the control unit 600 can always inject a predetermined amount of drug into the body through the adjustment of the application time. In other words, since the drug discharge rate may vary depending on the remaining amount of the drug in the micro-diaphragm chamber 110, the time for applying the second control signal to discharge only a part of the drug in the micro-diaphragm chamber 110 It is preferable to adjust it.

Thereafter, the control unit 600 terminates the application of the second control signal to the micro solenoid outflow valve 130, and transmits the first control signal to the micro solenoid injection valve 120 for a preset idle time The microcomputer 100 proceeds to step S100 of applying the first control signal to the microsolenoidal injection valve 120 after the dormant period so that the drug filled in the micro diaphragm chamber 110 is injected into the body at regular intervals ).

That is, in the case of a drug to be injected into the body three times a day, the value obtained by adding the open time, the intermediate delay time, the open time and the stop time of the micro solenoid outflow valve 130 of the micro solenoid injection valve 120 8 hours. Considering that the opening time of the micro solenoid injection valve 120, the intermediate delay time, and the opening time of the micro solenoid outflow valve 130 are each a few seconds long, the pause time is close to 8 hours It can be a long time.

While the present invention has been described in connection with what is presently considered to be practical exemplary embodiments, it is to be understood that the invention is not limited to the disclosed embodiments, but, on the contrary, It will be clear to those who have.

10: System housing
11: Storage inlet
12: Kadetar Port
13: Cartader access port
20: drug store
30: Pump
40: control board
50: Battery
100: pump
200: bottom cover
300: drug store
400: upper cover
500: middle cover
600:
700: Case
800:

Claims (10)

A lower cover having an upper surface opened to define a first containing space;
A lower cover opened to define a second storage space;
A drug reservoir inserted into the first containing space and storing the drug;
A pump disposed in the second compartment to provide power to release the drug stored in the drug reservoir through the discharge port into the body;
A control unit disposed in the second accommodation space and controlling a drug release amount through the pump; And
And an intermediate cover which divides the first storage space and the second storage space and has a connection module including a first path between the drug reservoir and the pump and a second path between the pump and the discharge port,
Wherein the connection module is installed on a partition wall of the intermediate cover,
The lower cover is provided with a first hole through which the connection module can pass,
A second hole is formed in the upper cover so as to receive a drug through a storage injection port of the drug reservoir,
An injection path for connecting the second hole and the storage injection port is formed in the intermediate cover,
Wherein the upper cover comprises:
And a priming hole to which the liquid for preventing air intrusion is supplied,
Wherein the connection module has a priming port for injecting liquid supplied through the priming hole on the second path.
delete The method according to claim 1,
And a case in which the lower cover is seated and the upper cover is exposed,
And an anchor which is in close contact with an internal body tissue is formed at a lower side of the case.
The method according to claim 1,
The pump includes:
A micro-diaphragm chamber in which the drug is charged;
A micro-solenoid injection valve for opening a path between the injection port connected to the first path by the first control signal and the micro-diaphragm chamber;
A micro-solenoid outlet valve for opening a path between the micro-diaphragm chamber and an outlet connected to the second path by a second control signal; And
And a pressure regulator for applying pressure to the diaphragm of the micro-diaphragm chamber to discharge a predetermined amount of drug through the outlet,
Wherein the control unit generates the first control signal for drug charging and outputs the generated first control signal to the microsolenoid injection valve to generate the second control signal for drug discharge, And outputting a second control signal to the micro-solenoid outflow valve.
The method of claim 4,
Wherein the micro-solenoid injection valve and the micro-solenoid outflow valve are normally closed valves.
The method of claim 4,
Wherein the pressure regulator includes a spring for applying an elastic force to the diaphragm.
The method of claim 4,
Wherein the pressure regulator comprises a propellant gas that pressurizes the septum.
The method of claim 4,
Wherein the first control signal and the second control signal are voltages applied by the control unit,
Wherein the controller adjusts the amount of the drug filled in the micro diaphragm chamber by adjusting a first opening time for applying the first control signal.
The method of claim 5,
Wherein the controller adjusts a discharge amount of the drug by adjusting a second opening time for applying the second control signal.
The method of claim 6,
Wherein the control unit further comprises a communication module for receiving a signal defining a length of a first opening time for applying the first control signal and a second opening time for applying the second control signal, system.

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