KR20210090434A - Apparatus For Medicine Infusion - Google Patents

Abstract

Disclosed is a drug injection device which is fixedly implanted between the skull and the scalp of a patient to inject a drug. The disclosed drug injection device comprises: a main body which is fixedly implanted while in contact with the skull and has an internal hole; a main body fixing part having an internal hole adjacent to the main body and fixedly coupled and fastened to the main body to face the same; a movable part which is positioned between the main body and the main body fixing part and has a drug injection hole in the center thereof, and of which the direction can be changed to a target point; a sealing part provided to hermetically seal the drug injection hole of the movable part and having inserted thereinto an injection needle for injecting a drug; a movable lid part which is positioned above the sealing part to hermetically fix the movable part, can prevent the sealing part from being separated and escaping from the outside, and identifies the implantation location of the drug injection device to guide a point for repeated administration; and at least two fastening members for fastening to the skull the upper portion of the main body and the upper portion of the main body fixing part. The main body comprises: a support portion having a movable accommodating hole for accommodating the movable part formed therein, and positioned on the upper portion of the skull for fixing and supporting the patient's skull; and an insertion portion to be inserted into the skull, and satisfies any one of conditional expressions 1 and 2.

Description

Drug infusion device {Apparatus For Medicine Infusion}

The present invention relates to a drug injection device, and by installing an intracerebral drug injection device for repeated administration of drugs in the skull of patients with cranial nerve diseases such as obesity, stroke, spinal nerve, dementia, etc. for a long period of time, it can be administered at a more accurate location. It relates to a drug injection device that allows

Recently, among diseases that lower quality of life, brain-related diseases that increase social and economic costs have become many social issues. Brain-related diseases, for example, degenerative brain diseases, psychiatric diseases, brain tumors and strokes, obesity, stroke, spinal nerves, etc. tend to increase every year. For patients with terminal cancer and chronic pain with brain disease, it is necessary to relieve pain through continuous and repeated administration and administration of analgesics. In addition, in the case of dementia patients suffering from degenerative brain diseases such as Alzheimer's disease or psychiatric diseases such as Parkinson's disease, it is necessary to continuously and repeatedly administer therapeutic agents such as chemical drugs and stem cells to maximize the therapeutic effect. have.

Currently, in order to increase the therapeutic effect of brain-related diseases, treatment methods through repeated oral and intravenous administration over a continuous period are widely used. However, the existing method has limitations in that it may be difficult to take the drug itself when the digestive system is weakened, a number of side effects may be induced by the systemic circulation of the therapeutic agent, and the physical pain and economic burden of the patient following inpatient treatment and administration of the therapeutic agent are large. .

On the other hand, the method of direct administration to the brain has the advantage that the effect is excellent compared to the existing method, but there are few side effects due to the systemic circulation of the drug. In the brain direct administration method, for example, in the case of a dementia disease patient, a therapeutic agent such as a chemical drug or stem cell may be directly administered to a target point, which is the hippocampus, for treatment. However, there is a difficulty in that drugs targeting the brain must pass through the blood-brain barrier (BBB). And, in order to increase the therapeutic effect, it is necessary to repeatedly administer to the correct target point.

Therefore, the prior art is developing a drug injection device that can be implanted in the brain for a long period of time and can be repeatedly administered to an accurate target point. However, since the position of the guide tube is changed or inserted in only one direction, the drug cannot be injected again at the correct position, so there is a limit in that the accuracy of the procedure may be lowered. In particular, when repeatedly administering to the same lesion in the brain parenchyma, the accuracy of the guide tube is lowered, and when repeated implantation of the drug injection device is required, the patient's economic cost burden increases and satisfactory therapeutic effect is reduced.

Republic of Korea Patent Publication No. 10-2014-0137308 (2014.12.02.) Republic of Korea Patent Publication No. 10-1100526 (2011.12.22.) US Patent Publication No. 2002-0138068 (2014.12.02.)

The present invention was devised in view of the above points, and the present invention targets a guide tube of a drug injection device that can be injected directly into the brain for treating brain diseases such as obesity, stroke, and spinal nerve in addition to dementia treatment as a lesion. An object of the present invention is to provide a drug injection device that precisely and accurately positions to be close to a point and enables direction change based on a central axis.

In addition, the present invention provides a drug injection device that allows easy identification of the implantation site by incising the implanted site without surgery through general anesthesia when repeatedly administering the drug, and repeatedly administering the drug to the site. It has a different purpose.

In addition, the present invention is to provide a drug injection device that prevents the reverse flow of the drug and the intrusion of contaminants from the outside due to repeated administration by double blocking the outside of the skull and the inside of the brain parenchyma with a sealing part and a driving stopper. Another object of the present invention There is this.

In order to achieve the above object, a drug injection device for injecting a drug by being implanted and fixed between the skull and scalp of a patient, comprising: a body which is implanted and fixed in contact with the skull and has an internal hole; a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed; a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point; a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted; a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and at least two fastening members for fastening the upper body and the upper body fixing part to the skull, wherein the main body has a movable receiving hole for accommodating the movable part therein, and is located on the upper part of the skull, the patient Supports fixed to the skull of the support; and an insertion unit inserted into the skull, and may satisfy at least one of Conditional Expressions 1 and 2 below.

<Condition 1>

<Condition 2>

Here, D ₁ is the size of the outer diameter of the insertion portion, D ₂ is the size of the inner diameter of the movable receiving hole, L ₁ is the insertion height of the insertion portion.

The support portion may have at least one fixing protrusion and a first fastening hole to satisfy the following conditional expression 3 .

<Condition 3>

Here, D ₃ is the size of the outer diameter of the support, L ₂ is the height of the support.

The fixing protrusion may satisfy the following Conditional Expression 4.

<Condition 4>

Here, D ₄ is the size of the outer diameter of the fixing projection, L ₃ is the height of the fixing projection.

A drug injection device for injecting a drug by being implanted and fixed between the skull and scalp of a patient, comprising: a main body which is implanted and fixed in contact with the skull and has an internal hole; a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed; a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point; a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted; a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and at least two fastening members for fastening the upper body and the upper body fixing part to the skull, wherein a fixing hole for fixing the outside so that the movable part does not move is formed in the center of the body fixing part. At least one second fastening hole for fixing the fastening member is inserted and fixed so as not to move, and the fixing hole and the main body fixing part have at least one of the following Conditional Expression 5 and/or the height of the main body fixing part 1mm to 9mm. can be satisfied

<Conditional Expression 5>

Here, D ₅ is the size of the outer diameter of the fixing hole, D ₆ is the size of the outer diameter of the fixing part of the body.

The main body fixing portion has an upper portion that protrudes in a curved surface, so that identification is possible; and a support coupling groove having a concave lower portion formed in a curved surface and matching the shape of the main body support to facilitate coupling, wherein the support coupling groove includes at least one protrusion receiving groove coupled to face the fixing protrusion and the first At least one head accommodating groove may be formed to face the fastening hole and be coupled, and the following conditional expression 6 may be satisfied.

<Conditional Expression 6>

Here, R ₁ means the radius of the support coupling groove.

A drug injection device for injecting a drug by being implanted and fixed between the skull and scalp of a patient, comprising: a main body which is implanted and fixed in contact with the skull and has an internal hole; a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed; a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point; a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted; a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and at least two fastening members for fastening the upper body and the upper body fixing part to the skull, wherein the movable part is located on the fastening member, the movable part has a curved surface to form an outer shape of the movable part; and a drug injection hole in which an internal hole is formed so that a drug is injected into the skull, and the movable part may satisfy the following conditional expression (7).

<Conditional Expression 7>

Here, D ₈ is the size of the outer diameter of the movable part, and L ₅ is the height of the movable part.

The movable part may be formed in a spherical shape having a sphericity of less than 0.03 mm.

The drug injection hole is a first receiving part for accommodating the sealing part located in the inner hole of the movable part; and a second accommodating part connected to the first accommodating part and located at the lower inside of the movable part and accommodating the injection needle inserted during drug injection, wherein each of the first accommodating part and the second accommodating part includes the following Conditional Expressions 8 and Conditional Expressions At least one of 9 may be satisfied.

<Conditional Expression 8>

<Conditional Expression 9>

Here, V ₁ is the volume of the internal space of the first accommodating part, and D ₉ is the size of the inner diameter of the second accommodating part.

The first accommodating part is formed with a screw thread from the start of the movable part inner hole to a point where the sealing part is accommodated, and the height at which the screw thread is formed may satisfy the following conditional expression 10.

<Conditional Expression 10>

Here, L ₅ denotes the total height of the first accommodating part and the second accommodating part, and L _5a denotes the height at which the screw thread is formed.

A drug injection device for injecting a drug by being implanted and fixed between the skull and scalp of a patient, comprising: a main body which is implanted and fixed in contact with the skull and has an internal hole; a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed; a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point; a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted; a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and at least two fastening members for fastening the upper body and the upper body fixing part directly to the skull, wherein the sealing part is the sealing part and the movable stopper is at least one of the following Conditional Expressions 11 and 12 can be satisfied

<Conditional Expression 11>

<Conditional Expression 12>

Here, D ₁₀ is the size of the outer diameter of the sealing part, D ₁₁ is the size of the outer diameter of the movable stopper, L ₆ is the height of the sealing portion, L ₇ is the height of the movable stopper.

The sealing part may be made of a silicon material.

The movable stopper includes an injection needle receiving part having a hole in the center into which the injection needle is injected; a position display unit including the needle receiving unit inside and positioned outside the movable unit; It may include a movable fastening member that is connected to the position display unit and has a screw thread formed on the outside and is fastened with a male and female screw thread to the drug injection hole.

The needle receiving unit may satisfy the following conditional expression 13.

<Conditional Expression 13>

Here, A ₁ denotes an angle of the upper end of the needle accommodating part among angles forming left and right with respect to the central axis, and A ₂ denotes an angle of the middle part of the needle accommodating part.

The position display unit may satisfy the following conditional expression 14.

<Conditional Expression 14>

Here, L ₇ means the total height of the movable stopper, and L _7a means the height of the position display part.

A drug injection device for injecting a drug by being implanted and fixed between the skull and scalp of a patient, comprising: a main body which is implanted and fixed in contact with the skull and has an internal hole; a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed; a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point; a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted; a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; And the fastening member is a body portion to be implanted and fixed in the skull; and a head part connected to and mounted on the body part, wherein the body part and the head part may satisfy at least one of the following Conditional Expressions 15 and 16.

<Conditional Expression 15>

<Conditional Expression 16>

Here, D ₁₁ is the size of the outer diameter of the body, D ₁₂ is the outer diameter of the head, L ₉ is the length of the body, L ₈ is the length of the head.

a horizontal groove positioned in the center of the head to be horizontally fastened to the fastening mechanism when fastening; and an identification groove formed so as to be identifiable linearly by dividing a horizontal axis and a vertical axis based on the horizontal groove, wherein the horizontal groove and the identification groove may satisfy the following conditional expression 17.

<Condition 17>

Here, D ₁₃ means the width of the identification groove, and D _8a means the size of the outer diameter of the horizontal groove.

The body portion is implanted and fixed in the skull and the screw thread is tapered to the end, and at least one pressure reducing groove satisfying the following condition 18 may be formed.

<Conditional Expression 18>

Here, D ₉ means the length of the body portion, and L _9a means the length of the portion in which the pressure reducing groove is formed.

A drug injection device for injecting a drug by being implanted and fixed between the skull and scalp of a patient, comprising: a main body which is implanted and fixed in contact with the skull and has an internal hole; a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed; a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point; a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted; a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and at least two fastening members for fastening the upper body and the upper body fixing part directly to the skull, wherein the drug injection device is connected to the movable part and enters the brain parenchyma to be inserted to a position close to the target, Further comprising a guide tube for guiding the injection needle for injecting the drug into the target point in the target direction, the guide tube may satisfy the following conditional expression 19.

<Conditional Expression 19>

Here, D _14a means the size of the inner diameter of the guide tube, and D _14b means the size of the outer diameter of the guide tube.

The guide tube is

It may include a length of 10 mm to 300 mm.

It is mounted on the lower end of the drug injection hole and connects between the movable part and the guide tube, and further includes a tube connection part having an insertion guide hole extending inside the guide tube, and the tube connection part is the following Conditional Expressions 20 and 21 At least one of these may be satisfied.

<Conditional Expression 20>

<Conditional Expression 21>

Here, D ₁₅ is the size of the outer diameter of the tube connection part, D ₁₆ is the size of the inner diameter of the tube connection part, and L ₁₀ is the height of the tube connection part.

The guide tube has at least one drug administration hole formed on one side or both sides so that the drug flows without accumulating, and the inner and outer diameters of the guide tube end are formed in a curved shape to minimize tissue damage when inserted into the skull. have.

The guide tube may be rotated in the direction of the target point on the left and right from the central axis with respect to the surface in contact with the skull and the maximum angle of deformation may be within 60˚.

In the drug injection device, at least one of the main body, the main body fixing part, the movable part, the movable stopper part and the guide tube may be made of polyether ether ketone.

The sealing unit may further include a filter for preventing foreign substances from being introduced into the sealing unit, and may include an integrated sealing filter membrane that is easy to replace and install at a time by integrating the filter and the sealing unit.

The sealing part is siloxane, silicone, dimethyl and vinyl groups 55 to 60% by weight, silane amine, 1.1.1-trimethylamine trimethylsilyl and silica hydrolysis products are 25 to 30% by weight, siloxane silicone, dimethyl and methylvinyl are A first mixture of 5 to 7% by weight; and 55 to 60% by weight of siloxane, silicone, dimethyl and vinyl groups, 25 to 30% by weight of silane amine, 1.1.1-trimethylaminetrimethylsilyl and silica hydrolysis products, 5 to 30% by weight of siloxane silicone, dimethyl and methylvinyl. 7% by weight, silicon siloxane, dimethyl and methyl hydrogen may include a second mixture of 1 to 5% by weight.

The sealing part may satisfy the following conditional expression 22 for the first mixture and the second mixture.

<Conditional expression 22>

Here, M ₁ means the first mixture, and M ₂ means the second mixture.

The drug injection device according to the present invention can easily identify the implantation site by incising the implanted site without surgery through general anesthesia when repeatedly administering the drug in order to increase the therapeutic effect after being implanted once, and the drug can be placed in the position. Because it can be administered, it has the advantage of saving economic and time burden and increasing the effect of treatment through repeated administration.

And the drug injection device according to the present invention rotates the movable part capable of changing the direction and the guide tube inserted therein in the direction of the target point, which is the lesion, and inserts the injection needle through the guide tube to accurately administer the drug to the target point. Therefore, the precision and accuracy of drug administration can be improved.

In addition, as the drug injection device according to the present invention double blocks the outside of the skull and the inside of the brain parenchyma with a sealing part and a driving stopper, it is possible to prevent the reverse flow of the drug and the intrusion of contaminants from the outside due to repeated administration, so side effects caused by infection can reduce

In addition, the drug injection device according to the present invention is made of a biocompatible material that does not bind to the brain tissue after transplantation, and thus has high implant stability, so that the patient can perform daily activities without immune rejection even after long-term transplantation.

1 is an assembled perspective view schematically showing a drug injection device according to an embodiment of the present invention.
FIG. 2 is a view showing a procedure for finding and installing the drug injection device of FIG. 1 using a stereotaxic guide mechanism to locate a target point in the skull of a patient.
Figure 3 is a cross-sectional view showing the state of injecting the drug after the drug injection device of Figure 2 is installed.
Figure 4 is a side cross-sectional view schematically showing the operation in which the drug injection device of Figure 3 can be fully assembled.
5 (a) to 5 (c) are each a plan view, a side view, and a side cross-sectional view showing the main body of the configuration of the drug injection device according to an embodiment of the present invention.
6(a) to 6(d) are a plan view, a bottom view, a cc' side cross-sectional view, and a dd' side cross-sectional view showing the main body fixing part among the configuration of the drug injection device according to an embodiment of the present invention.
7 (a) and 7 (b) are each a side view and a cross-sectional side view showing a movable part of the configuration of the drug injection device according to an embodiment of the present invention.
8(a) to 8(c) are a plan view, a side view, and a side cross-sectional view showing a driving stopper in the configuration of the drug injection device according to an embodiment of the present invention.
9 (a) and 9 (b) are each a plan view and a side view showing a fastening member in the configuration of the drug injection device according to an embodiment of the present invention.
10 (a) to 10 (c) are each a plan view, a side view, and a side cross-sectional view showing a guide tube in the configuration of the drug injection device according to an embodiment of the present invention.
11 (a) and 11 (b) are each a perspective view and a side cross-sectional view showing a first modified example of the sealing portion of the drug injection device according to the present invention.
12 is a side cross-sectional view showing a second modified example in which the filter is integrated into the sealing part of the drug injection device according to the present invention.
13 is a side cross-sectional view showing that the end of the guide tube of the drug injection device according to the present invention is deformed.
Figure 14 is a side cross-sectional view showing the drug injection device of the second embodiment according to the present invention.
Figure 15 is a side cross-sectional view showing the drug injection device of the third embodiment according to the present invention.
Figure 16 is a front view showing the drug injection device of the fourth embodiment according to the present invention.

Hereinafter, a stereotaxic guide mechanism according to an embodiment of the present invention will be described in detail with reference to the accompanying drawings. Here, the accompanying drawings are illustrated by exaggerating or simplifying a part for convenience and clarity of explanation and understanding of the configuration and operation of the technology, and each component does not exactly match the actual size.

1 is an assembled perspective view schematically showing a drug injection device according to an embodiment of the present invention.

Referring to FIG. 1 , the drug injection device 100 may be implanted and fixed between the skull 1 and the scalp 3 of the patient P to inject the drug. The drug injection device 100 may include a body 110 , a body fixing part 150 , a movable part 130 , a sealing part 160 and a movable stopper part 180 , and a fastening member 170 .

The body 110 may be implanted and fixed in contact with the skull 1 and an internal hole may be formed. In addition, the main body 110 may be coupled to the main body fixing part 150 and adjacent to each other to accommodate and fix the movable part 130 in the main body 110 inner hole. The body 110 may include a support part 115 , an insertion part 113 , and a movable accommodation hole 110a. The main body 110 includes a support part 115 to be positioned and supported on the skull 1, and the outer diameter of the support part 115 may be smaller than the outer diameter of the main body fixing part 150 and larger than the outer diameter of the movable part 130. . The support part 115 may be coupled to the main body fixing part 150 and adjacent to each other to accommodate and fix the movable part 130 in the main body 110 inner hole. The support part 115 is located on the upper part of the main body 110, and the fastening member 170 is inserted and fixed so as to be coupled to at least one first fastening hole 110b and the body fixing part 150 for fixing so as not to move. It may include at least one fixing protrusion 117 . The insertion part 113 is to be inserted into the skull 1, and may be located in contact. The movable accommodating hole 110a may accommodate the movable part 130 inside the main body 110 .

The body fixing part 150 may have an inner hole adjacent to the body 110 and may be coupled and fixed to face the body 110 to be fastened. In addition, the body fixing part 150 may include an identification part 157 , a fixing hole 150a , a second fastening hole 150b and a support coupling groove 157a . The identification unit 157 has an upper portion that protrudes to a curved surface, so that the implantation position of the drug injection device 100 can be identified. The fixing hole 150a may be fixed to the outside so that the movable part 130 does not move at the center. The second fastening hole 150b is made of at least one, and the fastening member 170 is inserted around the upper portion to be fixed so as not to move. The support coupling groove 157a is formed as a concave groove in which the surface in contact with the support part 115 coincides with the support part 115 , and may be easily coupled to the support part 115 . In addition, the support coupling groove (157a) may further form at least one of the head receiving groove (157b) and the projection receiving groove (157c). The head accommodating groove (157b) is a groove for accommodating the protrusion of the head portion 175 of the fastening member 170 coupled to the support portion 115, and when the main body 110 is coupled with the main body fixing portion 150, It is possible to reduce friction between the support part 115 and the mounting part 155 contacting the surface. In addition, the head accommodating groove (157b) can prevent a decrease in the fastening force of the fastening with the main body fixing part 150 as the head part 175 of the fastening member 170 fastened with the main body 110 interferes, and the main body height It can be easily combined with the government 150 by custom. The protrusion receiving groove 157c is formed at least one in the support coupling groove 157a and is positioned to face the fixing protrusion 117 of the support part 115 and can be accommodated and coupled thereto.

Therefore, the main body fixing part 150 includes the second fastening hole 150b, the support coupling groove 157a and the protrusion receiving groove 157c when combined with the main body 110 because it has a coupling force of at least three points or more. Even if they are transplanted to 1) for a long time, they do not separate from each other and the fixation force can be improved.

The movable part 130 is positioned between the main body 110 and the body fixing part 150 , and a drug injection hole 133 is formed in the center, so that the direction can be changed to the target point 7 . The movable part 130 is located in the movable accommodating hole 110a, and includes a movable body 131 having a curved shape and capable of changing the direction, and the movable body 131 has a hollow center inside the target point (7). A drug injection hole 133 to guide the drug to be injected may be formed. The movable part 130 may be formed in a spherical shape with a sphericity of less than 0.03 mm. When the movable part 130 exceeds 0.03 mm, the surface in contact with the movable receiving hole 110a of the main body 110 may be uneven, so it may be difficult to rotate in the direction of the desired target point 7 . In addition, the surface roughness (R _a ) of the movable part 130 may have a range of greater than 0.1 μm and less than 0.5 μm. If it is 0.1 μm or less, a problem may occur in which the fixing force is slightly deviated from the sphericity, and if it is 0.5 μm or more, the fixing force may be weakened because the surface is rough and causes friction when in contact with the body 110 . That is, there is a limit that it is difficult to make a complete rotation when adjusting the angle. In addition, the defect rate may be high when assembling the drug injection device 100 .

The drug injection hole 133 may include a first accommodating part 133a and a second accommodating part 133b. The first accommodating part 133a may accommodate the sealing part 160 located in the inner hole of the movable part 130 . The second accommodating part 133b is connected to the first accommodating part 133a and is located at the inner lower end of the movable part 130 and can accommodate the guide tube 140 and the injection needle 191 inserted during drug injection. The first accommodating part 133a may be formed with a screw thread from the start of the inner hole of the movable part 130 to the point at which the sealing part 160 is accommodated. The sealing part 160 is provided to seal the drug injection hole 133 of the movable part 130, and an injection needle 191 for injecting the drug may be inserted. The sealing part 160 is made of silicon, but is not limited thereto, and may be made of at least one of synthetic resin materials. The sealing unit 160 may be restored to its original shape again even when the needle 191 is inserted. Accordingly, the sealing unit 160 may be inserted into the movable unit 130 to block contaminants from the outside and prevent infection after brain transplantation of the drug injection device 100 .

The movable stopper 180 may be positioned above the sealing part 160 to seal and fix the movable part 130 and block the sealing part 160 from being separated from the outside. The movable stopper 180 may include a needle receiving portion 180a, a position display portion 185 and a movable fastening portion 183 . The needle receiving portion (180a) may be formed with a hole inclined downward so that the injection needle (191) is injected in the center. The position display unit 185 may include the needle receiving unit 180a therein and may be located outside the movable unit 130 . The movable fastening part 183 is connected to the position display part 185, and a screw thread is formed on the outside, so that it can be fastened with a male and female screw thread to the drug injection hole 133.

Referring to FIG. 1 , the drug injection device 100 may further include a guide tube 140 . The guide tube 140 is connected to the movable part 130 and enters the brain parenchyma 5 and can be inserted to a position close to the target point 7, and the injection needle 191 for injecting the drug into the target point 7 It can guide in the direction of the target point (7). The guide tube 140 coupled to the movable part 130 may be inserted in the direction of the target point 7 from the central axis CL with respect to the point in contact with the skull 1 . The guide tube 140 is mounted on the lower end of the drug injection hole 133 and may include a tube connection part 145 connecting the movable part 130 and the guide tube 140 . The tube connection part 145 may be formed with a hole extending from the inside of the guide tube 140 .

The drug injection device 100 according to the present invention includes at least one of the main body 110, the main body fixing part 150, the movable part 130, the movable stopper part 180, and the guide tube 140 is polyether ether ketone ( PEEK), but is not limited thereto, and may be manufactured by variously applying a material having body graft bonding properties.

The fastening member 170 may include at least two coupling the upper body 110 and the upper body fixing part 150 to the skull 1 . The fastening member 170 may include a body portion 173 and a head portion 175 . The body part 173 may fix at least one of the body 110 and the body fixing part 150 to be implanted and fixed in the skull 1 . The body portion 173 is placed and fixed in the skull 1 and has a tapered thread to the end thereof, and at least one pressure reducing groove 173a may be formed. The head part 175 is connected to the body part 173 and mounted, and is located in the center and horizontally and vertically based on the horizontal groove 175b and the horizontal groove 175b to be horizontally fastened with the fastening mechanism when fastening. It may include an identification groove (175a) formed to be identifiable linearly. In addition, the fastening member 170 may be made of a titanium material, but is not limited thereto, and may be manufactured by variously applying a material having body graft bondability and implant stability.

Figure 2 is a view showing the operation of finding and installing the location of the target point in the patient's skull (頭蓋骨) using the stereotaxic guide mechanism of the drug injection device of Figure 1, Figure 3 is after the drug injection device of Figure 2 is installed It is a cross-sectional view showing the state of injecting drugs.

Referring to FIGS. 2 and 3 , the insertion of the drug injection device 100 may be guided by using the stereotaxic guide device 10 when performing an operation on a patient P related to a brain disease requiring drug injection into the brain. Here, the brain disease may be related to, for example, brain tumor, stroke, Alzheimer's, a dementia disease, Parkinson's, a mental disease, depression, schizophrenia, and the like. The drug injection device 100 may make a 'U'-shaped incision in the position of the temporal bone, parietal bone, etc. of the skull 3 in order to puncture and implant the skull 3 of the patient P. In addition, the drug injection device 100 is composed of a main body 110 , a movable part 130 , a guide tube 140 , a body fixing part 150 , a sealing part 160 , and a movable stopper part 180 . The main body 110 is implanted in the skull 3, and the upper end of the main body 110 is located between the scalp 5 and the skull 3, and the lower end of the main body 110 is inserted into the skull 3 to be positioned. have. The movable part 130 is inserted into the main body 110 and has a spherical shape with an open upper part and can be turned to a target point 7 which is a lesion in the brain parenchyma (腦實質).

Referring to FIG. 2 , the orientation guide device 10 is coupled to the movable part 130 to change the direction of the guide tube 140 located on the central axis CL from the center CL to guide it to be positioned at the target point 7 . can do. Here, the orientation guide device 10 may include a guide handle 13 , a position adjusting unit 15 , a position adjusting handle unit 17 , and a bolt unit 19 . In detail, the guide handle 13 may be installed on the movable part 130 , and the guide tube 140 may be coupled to the inside of the long rod-shaped positioning part 15 to be inserted. In order to prevent the position adjusting unit 15 from shaking or breaking during insertion, the position adjusting handle unit 17 may be coupled and installed at the end of the position adjusting unit 15 . The stereotaxic guide device 100 may be separated and removed from the skull 3 after positioning the guide tube 140 as close as possible to the target point 7 .

On the other hand, FIG. 2 shows only the final state in which the guide tube 140 is positioned as the target point 7 using the stereotaxic guide mechanism 100 . The present invention is not limited thereto, and although not shown in the drawings, the stereotaxic guide device 10 may further include a connecting guide unit (not shown). The connection guide part may guide the guide tube 140 to be accurately inserted into the guide handle 13 . The connecting guide part is made of at least a pair of pipe-shaped parts and is detachable and may be additionally installed on the top of the guide handle 13 . In addition, one end of the connection guide part is inserted into the guide handle 13 and the other end is mounted on the guide handle 13 to further guide the insertion of the guide tube 140 . The connection guide part may be separated and removed when it comes into contact with the tube connection part 145 to be inserted. After removal, as shown in FIG. 2 , the front end of the positioning handle unit 17 may be positioned at the lower end of the movable unit 130 while pushing the tube connection unit 145 .

As shown in FIG. 3 , the guide tube 140 may have an injection needle 191 for injecting brain disease-related drugs therein. Here, the injection needle 191 may accommodate, for example, a trocar needle, a needle for inspection, and the like therein. However, without being limited thereto, various surgical instruments and equipment, for example, navigation probes, stimulation leads, ablation probes or catheters, injection or fluid delivery devices, biopsy needles, extraction tools, etc. may be inserted to perform diagnostic and/or therapeutic procedures. can run

In addition, various various brain disease-related drugs may be injected using the drug injection device 100 . For example, dementia-related chemicals such as amyloid hypothesis (substance that inhibits β-amyloid protein production), Aβ protein aggregation inhibitor, tau aggregation inhibitor cholinase inhibitor, NMDA receptor or antagonist, cholinergic precursor, antioxidant, diabetes treatment Drugs, human umbilical cord blood cells, human umbilical cord blood-derived mesenchymal stem cells, neural stem cells, stem cells such as bone marrow stem cells, drugs for treating mental disorders such as Parkinson’s, depression, schizophrenia, brain tumors and stroke-related therapeutic drugs, etc. may be included. .

2 and 3, a method of installing the drug injection device 100 according to the present invention as follows will be described in detail.

<Installation method>

The step of implanting the main body 110 of the drug injection device 100 by cutting the scalp 5 of the patient P and making a burr holl in the skull 1 may be performed (S10).

Using a navigation device (not shown) to find the location of the target point (7) through MRI imaging, the step of displaying the location on the skull 1 on the coordinates is performed (S20).

After the main body 110 is fixed to the skull 1 and fastened, the movable part 130 is inserted into the movable receiving hole 110a, and at least two fastening members 170 can be installed in the first fastening hole 110b ( S30).

It may be installed facing the main body fixing part 150 on the upper body 110 with the movable part 130 interposed therebetween. In addition, the fixing hole 150a formed in the body fixing part 150 and the movable receiving hole 110a of the body 110 may be installed to communicate while receiving the movable part 130 (S40). Next, at least two fastening members 170 are installed in the second fastening hole 150b formed in the main body fixing part 150 . At this time, the fastening member 170 may perform a step of fixing only the movable part 130 to the extent that it moves and installing the guide handle 13 on the movable part 130 (S50).

To find the target point 7 while installing a probe receiving part (not shown) to which the optical guide part 123 is assembled inside the guide handle 13 and inserting a navigation probe (not shown) therein to change the direction A step of adjusting may be performed (S60).

When the correct target point 7 is set, the navigation probe (not shown) and the probe receiving unit (not shown) can be separated and removed from the guide handle 13 ( S70 ).

A guide tube 140 including a tube connection part 145 is prepared. Next, a set is prepared by fastening the positioning handle 17 and the bolt 19 to the positioning part 15 . At this time, when the position adjustment handle portion 17 reaches the portion in contact with the tube connection portion 145, the bolt portion 19 can be fastened to the fastening receiving portion 179 of the position adjustment handle portion 17 to be fixed (S80). .

By installing a pair of detachable connection guide parts (not shown) at the upper end of the guide handle 13, the insertion of the guide tube 140 including the position adjusting part 15 in the inner center thereof can be further guided. . When the tube connection part 145 comes into contact with the connection guide part (not shown), the connection guide part (not shown) is separated and removed, and the front end of the position adjustment handle part 17 pushes the tube connection part 145 and the movable part 130 at the bottom. Inserting until the position is performed (S90).

The positioning unit 15 is positioned at the end of the guide tube 140 and moved together, rotates in the direction of the target point 7 in the brain parenchyma 5, and reaches the target point 7 ahead of the guide tube 140. The position adjustment handle unit 17 can be adjusted (S100).

When the guide tube 140 is located close to the target point 7, the positioning unit 15 set is separated and removed from the guide handle 13, and finally the guide handle 13 can also be separated and removed from the movable unit 130. (S110).

It can be installed by inserting the sealing part 160 into the movable part 130, and fastening the movable stopper part 180 to the upper part using a dedicated driver (not shown). In addition, the drug injection device 100 can be fixed on the skull 1 of the patient P by fastening the fastening member 170 loosely located on the upper part of the body 110 once again (S120).

After the initial implantation of the drug injection device 100 is completed, the position display unit 185 of the movable stopper 180 can be visually identified to find the position (S130).

The injection needle 191 including the therapeutic agent 195 includes the needle receiving part 180a of the movable stopper 180, the sealing part 160, the insertion guide hole 145a of the tube connection part 145, and the guide tube 140) The therapeutic agent 195 may be repeatedly administered over a long period of time by sequentially inserting it along the direction and inserting it into the target point 7 (S140).

Figure 4 is a side cross-sectional view schematically showing the operation in which the drug injection device of Figure 3 can be fully assembled.

4, the drug injection device 100 according to the present invention has a main body 110, a movable part 130, a body fixing part 150, a guide tube 140, a sealing part 160 and a movable stopper part ( 180) and can be fully assembled. The main body 110 may include an insertion unit 113 having a lower end inserted into the skull 1 , and a support unit 115 having an upper end horizontally supporting the upper portion of the skull 1 . The mounting part 155 of the main body fixing part 150 may be in contact with the support part 115 and may be installed. At this time, a fastening member 170 may be further installed therebetween in order to further increase the coupling and fixing force between the main body 110 and the main body fixing part 150 . In detail, the second fastening hole 150b is formed at one end of the support part 115 , and the fastening member 170 may be installed in the second fastening hole 150b. In addition, the other end of the support part 115 is formed with a head receiving groove 157b in contact with the first fastening hole 110b of the main body 110, and the fastening member 170 fastened to the first fastening hole 110b. ) of the head portion 175 may be seated. Accordingly, the drug injection device 100 is formed at at least three points where each of the first fastening hole 110b and the second fastening hole 150b is different from each other. That is, the fastening member 170 may be installed at at least six points when the main body 110 and the main body fixing part 150 are fastened. Therefore, the drug injection device 100 is not easy to separate and detach between the main body 110 and the main body fixing unit 150 after implantation, and the initial implant fixing force can be maintained.

In addition, the movable receiving hole (110a) formed in the center of the main body (110) may be installed with a movable body (131) capable of changing the direction of the outer shape of the curved surface. The center of the movable body 131 is hollow inside the drug injection hole 133 to guide the injection of the drug to the target point (7) can be formed. The guide tube 140 is installed at the bottom of the drug injection hole 133 and can be rotated in the direction of the target point (7). That is, the guide tube 140 coupled to the movable part 130 is the maximum angle of the movable range that can be rotated in the direction of the target point 7 on the left and right from the central axis CL with respect to the surface in contact with the skull 1 . may be within 60°. When the maximum angle exceeds 60°, an excessive load is generated on one side of the mounting portion 155 coupled to the support 115 , and the coupling balance is broken, so the mounting portion 155 may be separated and separated. In addition, when the guide tube 140 installed in the movable part 130 is positioned in the direction of the target point 7, the tube connection part 145 is seated in the drug injection hole 133, and the sealing part is placed on the tube connection part 145. 160 may be installed. Here, the sealing part 160 may have a predetermined height (L ₆ ) and a size (D ₁₀ ) of an outer diameter to be inserted into the movable part 130 . The condition range of the sealing unit 160 will be described later with reference to FIG. 8 . The movable fastening member 170 of the movable stopper 180 may be installed on the sealing part 160 . The movable stopper 180 may have a needle receiving portion 180a hollow in the center. In addition, the position display unit 185 of the movable stopper 180 may be formed in a hexagonal shape to indicate the implanted position. Therefore, when the drug injection device 100 is implanted in the skull 1 and then the scalp 3 is covered and sutured, the implanted position is found through the position display unit 185 and the injection needle 191 is inserted into the needle receiving unit 180a. , the sealing part 160 , the insertion guide hole 145a of the tube connection part 145 , and the guide tube 140 may be inserted in this order.

5 (a) to 5 (c) are each a plan view, a side view and a side cross-sectional view showing the main body of the configuration of the drug injection device according to an embodiment of the present invention.

Referring to FIGS. 5A to 5C , the main body 110 may have a movable accommodating hole 110a for accommodating the movable part 130 therein. And the main body 110 may include a support part 115 that is fixedly supported to the skull 1 of the patient P and an insertion part 113 that is inserted into the skull 1 to be positioned on the skull 1, and may include .

Also, the main body 110 may satisfy at least one of Equations 1 and 2 below.

Here, D ₁ is the size of the outer diameter of the insertion part 113 , D ₂ is the size of the inner diameter of the movable receiving hole 110a , and L ₁ is the insertion height of the insertion part 113 .

If it deviates from the lower limit of Equation 1, it may be difficult to fix the movable part 130 because the thickness constituting the main body 110 becomes thin, and if it deviates from the upper limit of Equation 1, the movable part 130 is not seated and may be exposed to the outside. This may increase the risk of infection, etc. Therefore, when the condition range of Equation 1 is satisfied, the main body 110 may be positioned between the skull 1 and the scalp 3, and the movable part 130 is seated in the movable receiving hole 110a to be coupled and installed. It may have an appropriate thickness.

On the other hand, when the lower limit of Equation 2 is exceeded, the space for accommodating the movable part 130 cannot come out as the insertion part 113 has a height lower than the thickness of the skull 1, and when it deviates from the upper limit of Equation 2 Since the main body 110 may have a thickness of the insertion part 113 that presses the brain parenchyma 5 beyond the thickness of the skull 1, it may cause side effects such as headache and dizziness to the patient P after the procedure. Therefore, when the condition range of Equation 2 is satisfied, the insertion unit 113 is inserted into the skull 1 to have an appropriate height that does not press the cerebral parenchyma 5 .

The support part 115 may include a first fastening hole 110b and a fixing protrusion 117 . At least one sieve fastening hole 110b is positioned above the main body 110, and the fastening member 170 may be inserted and fixed so as not to move. The fixing protrusion 117 is made of at least one and may be fixed to be coupled to the body fixing part 150 .

At least one fixing protrusion 117 and a first fastening hole 110b are formed to satisfy Equation 3 below.

Here, D ₃ is the size of the outer diameter of the support part 115 , and L ₂ is the height of the support part 115 .

If it is outside the lower limit of Equation 3, it may be difficult to be stably seated on the skull 1 because the height compared to the outer diameter of the support part 115 is high, and when it is outside the upper limit of Equation 3, the outer diameter of the support part 115 increases as the outer diameter of the support part 115 increases. 1 The distance between the fastening holes (110b) increases, and as time passes, the fixing force may be weakened. Therefore, when the condition range of Equation 3 is satisfied, the support part 115 is easy to mount the insertion part 113 inserted into the skull 1, and the fixing protrusion 117 and the first fastening hole 110b are formed. Since it can have an optimal diameter and height, fixing force and stability can be secured.

The fixing protrusion 117 may satisfy Equation 4 below.

Here, D ₄ is the size of the outer diameter of the fixing projection 117, L ₃ is the height of the fixing projection (117).

When the lower limit of Equation 4 is exceeded, the height of the fixing protrusion 117 is increased, so it is easy to be damaged when combined with the main body fixing part 150, and even if it is fastened, a part of the body fixing part 150 floats upward, so that the movable part 130 is fixed. This may not occur, and when the upper limit of Equation 4 is exceeded, the fixing function of the fixing protrusion 117 may be lost as the height of the fixing protrusion 117 is lowered. Therefore, when the condition range of Equation 4 is satisfied, the fixing force can be maintained even after a time without the main body fixing part 150 and the support part 115 being rotated or separated from being separated after fastening.

6(a) to 6(d) are a plan view, a bottom view, a c-c' side cross-sectional view, and a d-d' side cross-sectional view showing the main body fixing part among the configuration of the drug injection device according to an embodiment of the present invention.

Referring to FIGS. 6(a) to 6(d) , the body fixing part 150 may face the body 110 and be coupled and fixed to be fastened. The body fixing part 150 may have a fixing hole 150a for fixing the outside so that the movable part 130 does not move at the center thereof. In addition, the main body fixing part 150 may be formed with at least one second fastening hole 150b in which the fastening member 170 is inserted and fixed so as not to move around the upper portion.

Figure 6 (c) is a side cross-sectional view when the top view (a) of the main body fixing part 150 cut along c-c'. A fixing hole 150a is formed at the upper end of the main body fixing part 150, and a second fastening hole 150b is formed in the mounting part 155 positioned to face the body 110, and the fastening member 170 is installed. can be combined.

6 (d) is a side cross-sectional view when the bottom view (b) of the main body fixing part 150 cut along d-d'. The body fixing part 150 may include an identification part 157 having a fixing hole 150a formed in the center and capable of determining the implantation position when viewed from the outside. The identification part 157 has a convexly protruding shape compared to the mounting part 155, and a head receiving groove 157b facing the first fastening hole 110b of the main body 110 may be formed on its bottom surface. have. The head accommodating groove 157b may have a head portion 175 of the fastening member 170 installed in the first fastening hole 110b.

The fixing hole 150a and the body fixing part 150 may satisfy at least one of the following Equation 5 and/or the height of the body fixing part 150 from 1 mm to 9 mm.

Here, D ₅ is the size of the outer diameter of the fixing hole (150a), D ₆ is the size of the outer diameter of the body fixing portion (150).

When the lower limit of Equation 5 is exceeded, as the fixing hole 150a at the center of the main body fixing part 150 increases, the portion exposed from the outside increases, and infection problems may occur, and when it deviates from the upper limit of Equation 5, the main body Since the fixing hole 150a at the center of the fixing part 150 is too small, it may be difficult for at least one of the sealing part 160 and the movable part 130 to be inserted into the fixing hole 150a. Therefore, when the condition range of Equation 5 is satisfied, it is coupled with the main body 110 to easily maintain the fixing force, and the sealing part 160 and the movable part 130 are inserted into the fixing hole 150a to block contaminants from the outside. This can prevent infection.

In addition, when the height of the main body fixing part 150 is out of the range of 1mm to 9mm, it is higher than the height of the scalp 3 of the patient P, so that it can be formed to protrude after transplantation, so it is inconvenient to the daily life of the patient P may cause Therefore, when the height of the main body fixing part 150 satisfies the range of 1mm to 9mm, there is no significant difference in appearance after transplantation, so the discomfort felt by the patient P is reduced and damage caused by external shocks can be reduced, and the patient (P) ) to maintain a smooth daily life.

6(a) and 6(b), the body fixing part 150 includes an identification part 157, a fixing hole 150a, a second fastening hole 150b, and a support coupling groove 157a. can do. The identification unit 157 has an upper portion that protrudes to a curved surface, so that the implantation position of the drug injection device 100 can be identified. The fixing hole 150a may be fixed to the outside so that the movable part 130 does not move at the center. The second fastening hole 150b may be composed of at least one fastening member 170 inserted around the upper portion and fixed so as not to move. The support coupling groove (157a) is formed to be concave in the lower portion of the curved surface, coincides with the shape of the support portion 115 of the main body 110, and can be easily coupled. In addition, the support coupling groove 157a includes at least one projection receiving groove 157c coupled to face the fixing projection 117 therein, and the support coupling groove 157a may satisfy Equation 6 below. .

Here, R ₁ means the radius of the support coupling groove (157a).

If it is outside the lower limit of Equation 6, since it is difficult to accommodate the support 115 when combined with the main body 110, the fixing force may be weakened, and when it is outside the upper limit of Equation 6, the space remaining to accommodate the body 110 As this occurs, the coupling and fixing force with the main body 110 may be weakened. Therefore, when the condition range of Equation 6 is satisfied, the support coupling groove 157a can have a certain area generated when the circle is divided into thirds, so it matches the shape of the support part 115 and does not separate even if it is coupled for a long period of time. can keep

7 (a) and 7 (b) are each a side view and a side cross-sectional view showing a movable part of the configuration of the drug injection device according to an embodiment of the present invention.

7 (a) and 7 (b), the movable part 130 is located between the main body 110 and the body fixing part 150, the drug injection hole 133 is formed in the center of the target point (7) ), the position may be adjusted. The movable part 130 may include a movable part 130 and a drug injection hole 133 . The movable part 130 is located between the movable receiving groove 110a and the fixing hole 150a, and forms the outer shape of the movable part 130 with a curved surface, and the position can be adjusted. The drug injection hole 133 may have a hole formed therein so that the drug is injected into the skull 1 .

The movable part 130 may satisfy Equation 7 below.

Here, D ₈ is the size of the outer diameter of the movable part 130 , and L ₅ is the height of the movable part 130 .

When the lower limit of Equation 7 is exceeded, since the height of the movable part 130 is increased, there is a limit to provide an internal space for inserting the sealing part 160 and rotation may be difficult, and when it is outside the upper limit of Equation 7, the movable part As the outer diameter of 130 increases, it may be difficult to fasten the body fixing part 150 to the upper part. In addition, it may cause discomfort and side effects to the patient P after the procedure by pressing the brain parenchyma (5). Accordingly, when the condition range of Equation 7 is satisfied, the movable unit 130 may have a spherical shape and be positioned between the main body 110 and the main body fixing unit 150 to rotate in the direction of the target point 7 .

The drug injection hole 133 is connected to the first accommodating part 133a and the first accommodating part 133a for accommodating the sealing part 160 positioned in the movable part 130 inner hole, and is located at the lower end inside the movable part 130 . It may include a second accommodating part (133b) for accommodating the injection needle inserted during drug injection. The first accommodating part 133a may be formed with a screw thread from the start of the inner hole of the movable part 130 to the point at which the sealing part 160 is accommodated.

Each of the first accommodating part 133a and the second accommodating part 133b may satisfy at least one of Equations 8 and 9 below.

Here, V ₁ is the internal space volume of the first accommodating part 133a, and D ₉ is the size of the inner diameter of the second accommodating part 133b.

When the lower limit of Equation 8 is exceeded, the volume of the inner space of the first accommodating part 133a becomes larger than the inner diameter size of the second accommodating part 133b, so that when the guide tube 140 is inserted, the second accommodating part 133b is found and inserted. It may be difficult, and if it is outside the upper limit of Equation 8, the size of the inner diameter of the second accommodating part 133b becomes larger than the internal space volume of the first accommodating part 133a, so it may be difficult to position when the guide tube 140 is inserted, and after transplantation The holding force may decrease over time. Therefore, when the condition range of Equation 8 is satisfied, the sealing unit 160 is accommodated in the first receiving unit 133a to block contaminants from the outside, thereby protecting it from penetrating the brain parenchyma 5 . In addition, since a space for storing the drug can be secured in the first accommodating part 133a, a drug requiring repeated administration in a certain amount, such as a treatment for dementia and a treatment for brain disease-related pain, accumulates and passes through the guide tube 140 while passing through the guide tube 140 . It can be administered to the target point (7). Accordingly, the first and second accommodating parts 133b of the movable part 130 satisfying the condition range of Equation 8 may improve the repeated administration function of the drug injection device 100 .

On the other hand, when it is outside the lower limit of Equation 9, it may be difficult to insert the guide tube 140 into the second accommodating part 133b, and when it deviates from the upper limit of Equation 9, the inner diameter of the second accommodating part 133b is the guide tube As the outer diameter of 140 increases, a gap that is an extra space may be generated. When the drug is injected into the gap, it is administered to a part of the brain parenchyma (5) other than the target point (7), which may cause side effects. Therefore, when the condition range of Equation 9 is satisfied, since the inner diameter of the second accommodating part 133b is suitably coupled to the outer diameter of the guide tube 140, the drug can be precisely and accurately administered to the target point 7 during drug injection. can

The first accommodating part 133a may be formed with a screw thread from the start of the inner hole of the movable part 130 to the point where the sealing part 160 is accommodated.

Here, the height at which the screw thread is formed may satisfy Equation 10 below.

Here, L ₅ denotes the total height of the first accommodating part 133a and the second accommodating part 133b, and L _5a denotes the height formed by the screw thread.

When it is outside the lower limit of Equation 10, the height formed by the screw thread may be difficult to be installed with the movable stopper 180, and when it is outside the upper limit of Equation 10, the entire first and second accommodating parts 133a and 133b Since most of the height is the same as the height formed by the screw thread, it is difficult to accommodate the sealing part 160 inside the second accommodating part 133b, and even if it is accommodated, the sealing part 160 may be damaged in the threaded part of the side. Therefore, when the condition range of Equation 10 is satisfied, the total height of the first and second accommodating parts 133a and 133b can accommodate the sealing part 160 and the guide tube 140 , and the height formed by the screw thread It is fastened with the movable stopper 180 to block contaminants from the outside.

8(a) to 8(c) are a plan view, a side view, and a side cross-sectional view showing a driving stopper in the configuration of the drug injection device according to an embodiment of the present invention.

Referring to FIGS. 8(a) to 8(c) , the movable stopper 180 may include a needle receiving part 180a, a position display part 185 and a movable fastening part 183 . The needle accommodating part 180a is a hole into which the needle 191 is injected in the center of the movable stopper 180, and a funnel that narrows toward the inside so that the needle 191 can be inserted into the center no matter which direction the needle 191 is inserted. may have a shape. The position display unit 185 is positioned on the movable unit 130 and is formed in a hexagonal shape, and a corner portion of the hexagon may be molded. However, the present invention is not limited thereto and may be applied in various shapes capable of indicating a position. Accordingly, the position display unit 185 may have a function of identifying the needle receiving unit 180a when repeatedly administering the drug through the drug injection device 100 so that the needle receiving unit 180a can reach the operator's hand and discover the drug injection position. . The movable fastening part 183 is connected to the position display part 185, and a screw thread is formed on the outside, so that it can be fastened with a male and female screw thread to the drug injection hole 133.

The sealing unit 160 and the movable stopper 180 may satisfy at least one of Equations 11 and 12 below.

Here, D ₁₀ is the size of the outer diameter of the sealing part 160, D ₁₁ is the size of the outer diameter of the movable stopper 180, L ₆ is the height of the sealing portion 160, L ₇ is the movable stopper 180 is the height of

When it deviates from the lower limit of Equation 11, the outer diameter of the sealing part 160 becomes larger to push the movable stopper 180 blocking the upper part, and foreign substances from the outside penetrate between the pushed-out gaps, which may cause side effects. have. When it deviates from the upper limit of Equation 11, the sealing part 160 may not be fixed in the movable part 130 because it may be relatively small, and the injection needle 191 inserted through the movable stopper 180 is sealed. It may be difficult to pass through the portion 160 . Therefore, when the condition range of Equation 11 is satisfied, the movable stopper 180 can always block the sealing part 160 and prevent foreign substances from penetrating from the outside.

On the other hand, when the lower limit of Equation 12 is exceeded, since the height of the sealing part 160 is relatively large, there may be a limit in which it is difficult for the movable stopper 180 to be fastened to the inside of the movable part 130, and the upper limit of Equation 12 is In the case of deviation, as the height of the movable stopper 180 is relatively increased, it may protrude higher than the scalp 3 out of the fixing hole 150a of the main body fixing part 150 after fastening with the movable part 130 . . Such a state may cause the patient P to feel discomfort in daily life after implantation of the drug injection device 100 and, if worse, may cause side effects such as pain-inducing symptoms. Therefore, when the condition range of Equation 12 is satisfied, the sealing part 160 is suitable to be accommodated in the movable part 130, and as the movable stopper part 180 is blocked on the upper part thereof, foreign substances and contamination from the outside can be blocked. Therefore, it can have transplant suitability and stability. In addition, the sealing part 160 and the movable stopper 180 having an appropriate height are located between the skull 1 and the scalp 3 without protruding so that the patient P can smoothly conduct daily life after transplantation. have.

The needle receiving part 180a may satisfy Equation 13 below.

Here, A ₁ denotes an angle of the upper end of the needle accommodating part 180a among angles forming left and right with respect to the central axis, and A ₂ denotes an angle of the middle part of the needle accommodating part 180a.

When out of the condition range of Equation 13, when the needle 191 passes through the top of the needle receiving part 180a, the path direction of the injection needle 191 changes as the angle of the middle part rapidly increases, so that it is difficult to break or insert can When the condition range of Equation 13 is satisfied, even if the needle 191 is inserted in any direction when the needle 191 comes into contact with the upper end of the needle receiving part 180a from the outside, finally the lower end of the needle receiving part 180a It can be inserted in the direction of the desired target point (7) through it.

The position display unit 185 may satisfy Equation 14 below.

Here, L ₇ means the total height of the movable stopper 180 , and L _7a means the height of the position display part 185 .

When the lower limit of Equation 14 is exceeded, since the movable fastening part 183 occupies most of the movable stopper 180, the coupling with the movable part 130 may be easy, but from the movable part 130 in the process of installation and separation and removal. It may be difficult to separate the movable stopper 180, and when it is out of the upper limit of Equation 14, since the movable fastening part 183 hardly occupies the movable stopper 180, there is little difficulty in fastening with the movable part 130. there may be Therefore, when the condition range of Equation 14 is satisfied, the movable stopper 180 is fastened to the movable part 130 to block the inflow of contaminants from the outside, and the coupling and separation and separation can be easy.

9 (a) and 9 (b) are each a plan view and a side view showing a fastening member in the configuration of the drug injection device according to an embodiment of the present invention.

9 (a) and 9 (b), the fastening member 170 may include at least two coupling the upper body 110 and the upper body fixing part 150 to the skull (1). . The fastening member 170 may include a body portion 173 that is implanted and fixed in the skull and a head portion 175 connected to and mounted on the body portion 173 .

The body portion 173 and the head portion 175 may satisfy at least one of Equations 15 and 16 below.

Here, D ₁₁ means the size of the outer diameter of the body portion 173, D ₁₂ means the size of the outer diameter of the head portion 175, L ₉ means the length of the body portion 173, L ₈ is the It means the length of the head portion 175.

When the lower limit of Equation 15 is exceeded, the diameter of the body 173 becomes larger than the diameter of the head 175, so it can fall into the hole to be fastened without being mounted after fastening, and when it is outside the upper limit of Equation 15, the head portion 175 may be relatively large, so that it is difficult to be fastened due to interference by the body fixing unit 150 , and the strength of the body 173 is relatively weak, so that the fixing force is lowered, and stable fastening may not be possible. Therefore, when the condition range of Equation 15 is satisfied, the fastening member 170 can fix the main body 110 and the main body fixing part 150, and the implantation stability and fixation force of the drug injection device 100 can be improved. .

On the other hand, if it is outside the lower limit of Equation 16, it may be difficult to fix and support the transplanted body 173 as the length of the head 175 is relatively long, and when it deviates from the upper limit of Equation 16, the body portion ( 173) is relatively long, leaving the skull (1) and pressing to the cerebral parenchyma (5) may cause side effects after transplantation. Therefore, when the condition range of Equation 16 is satisfied, the fastening member 170 is implanted in the skull 1 by having an appropriate ratio between the head portion 175 and the body portion 173 to fix the drug injection device 100 . can do it

The head part 175 is located in the center and is formed so as to be horizontally fastened to the fastening mechanism when fastening, and a horizontal groove (175b) and a horizontal groove (175b), which are formed so as to be identifiable linearly by dividing the horizontal axis and the vertical axis. may include.

The horizontal groove 175b and the identification groove 175a may satisfy Equation 17 below.

Here, L _8a means the depth of the identification groove (175a), D ₁₃ means the size of the outer diameter of the horizontal groove (175b).

When it deviates from the lower limit of Equation 17, the function of the horizontal groove 175b may be lost as the length of the identification groove 175a becomes relatively long, and when it deviates from the upper limit of Equation 17, the outer diameter of the horizontal groove 175b As the size is relatively increased, the identification function of the identification groove 175a may be reduced. Therefore, when the condition range of Equation 17 is satisfied, the head part 175 has both a function of identifying the identification groove 175a and a function of allowing the fastening member 170 of the horizontal groove 175b to be fastened to fit horizontally. can

The body portion 173 is implanted and fixed in the skull and has a thread tapered to the end thereof, and at least one pressure reducing groove 173a satisfying the following Equation 18 may be formed.

Here, L ₉ means the length of the body portion 173, L _9a means the length of the portion in which the pressure reducing groove (173a) is formed.

When the lower limit of Equation 18 is exceeded, since the pressure reducing groove 173a is designed to be relatively longer than the length of the body 173, the function of the fastening member 170 may be lost and the fixing force may be weakened, When it is outside the upper limit, it is possible to increase the pressure on the bone tissue during implantation as a fastening member 170 having almost no pressure reduction groove (173a). When transplanted for a long time as described above, bone tissue may be damaged and cause inflammation and, in severe cases, may lead to side effects of transplantation surgery. Therefore, when the condition range of Equation 18 is satisfied, when the fastening member 170 having the pressure reducing groove 173a is implanted in the bone, the pressure that damages the bone tissue can be relatively weakened, thereby minimizing bone damage.

10 (a) to 10 (c) are each a plan view, a side view, and a side cross-sectional view showing a guide tube in the configuration of the drug injection device according to an embodiment of the present invention.

Referring to FIGS. 10 ( a ) to 10 ( c ), the guide tube 140 may guide the injection needle for injecting the drug into the target point 7 in the target direction. And the guide tube 140 may have a smooth surface to minimize damage when passing through the brain parenchyma (5).

In addition, the guide tube 140 may have a length ranging from 10 mm to 300 mm, and may satisfy Equation 19 below.

Here, D _14a means the size of the inner diameter of the guide tube 140 , and D _14b means the size of the outer diameter of the guide tube 140 .

When the lower limit of Equation 19 is exceeded, the inside of the guide tube 140 may be torn or damaged when the needle 191 passes due to the thin thickness of the guide tube 140 when the needle 191 is inserted. In addition, when the guide tube 140 is inserted into the cerebral parenchyma (5), the strength is too weak to cause side effects due to adhesion to the cerebral parenchyma (5), or the function of accommodating and guiding the needle (191) may be lost, Equation If it is outside the upper limit of 19, the thickness of the guide tube 140 is thick, so it may be difficult to insert the injection needle 191. In addition, the guide tube 140 may cause damage when inserted into the brain parenchyma (5) because the insertion strength becomes stronger according to the thickness. Therefore, when the condition range of Equation 19 is satisfied, the guide tube 140 may be inserted first so that damage to the brain parenchyma 5 is minimized, and then the injection needle 191 will be accommodated inside the guide tube 140 . When the target point (7) can be guided to be put in the direction.

Meanwhile, the guide tube 140 may further include a tube connection part 145 . The tube connection part 145 is mounted on the lower end of the drug injection hole 133 and connects between the movable part 130 and the guide tube 140, and an insertion guide hole 145a extending from the inside of the inner guide tube 140 may be formed. have. The insertion guide hole 145a may have a funnel shape that becomes narrower downward, but is not limited thereto, and may be formed in various shapes capable of guiding in the central direction. Accordingly, the insertion guide hole 145a is formed with the needle receiving portion 180a and the needle receiving portion 180a so that the injection needle 191 is accurately inserted into the target point 7 even if it is twisted in a direction other than the center when it passes through the needle receiving portion 180a. Together they can serve as double guides in the central direction.

The tube connection part 145 may satisfy at least one of Equations 20 and 21 below.

Here, D ₁₅ is the size of the outer diameter of the tube connection part 145 , D ₁₆ is the size of the inner diameter of the tube connection part 145 , and L ₁₀ is the height of the tube connection part 145 .

If it deviates from the lower limit of Equation 20, since the thickness of the tube connecting portion 145 may be reduced as the inner diameter of the tube connecting portion 145 is relatively large, the injection needle 191 may be torn or damaged when inserted, When the upper limit of 20 is exceeded, since the thickness of the tube connection part 145 is increased, the internal space is small, so insertion and separation of the needle 191 may be difficult. Accordingly, when the condition range of Equation 20 is satisfied, the tube connection part 145 is supported and fixed to the lower end of the movable part 130 , so that it is not easily separated and can be stably coupled. In addition, the tube connection portion 145 can be guided in the direction of the target point (7) as the needle 191 passes into the interior.

On the other hand, when the lower limit of Equation 21 is exceeded, since the height of the tube connection part 145 is relatively low and the supporting force may be weakened, it may be separated into the cerebral parenchyma (5), which may cause side effects, and of Equation 21 When the upper limit is exceeded, the height of the tube connection part 145 is relatively high, and there may be a limit in being accommodated together with the sealing part 160 inside the movable part 130 . Therefore, when the condition range of Equation 21 is satisfied, the tube connection part 145 is installed inside the movable part 130 and can be fixedly supported, and the sealing part 160 is installed on the upper part to block contaminants from the outside. can make it

The guide tube 140 may have at least one drug administration hole 140a formed on one side or both sides so that the drug flows without accumulating. In addition, the guide tube 140 may have a shape in which the inner and outer diameters of the ends are formed in a curved shape to minimize tissue damage when inserted into the skull 1 .

The drug injection device 100 has at least one of the main body 110, the main body fixing part 150, the movable part 130, the movable stopper part 180 and the guide tube 140 made of polyether ether ketone (PEEK). can

The fastening member 170 may be made of a titanium material. However, the present invention is not limited thereto, and the drug injection device 100 and the fastening member 170 may be variously applied as long as the material has good body transplantation suitability and stability and is hard and resistant to external contamination.

11 is a perspective view and a side cross-sectional view showing a first modified example of the sealing part of the drug injection device according to the present invention.

Referring to FIG. 11 , a central guide groove 160a may be further formed in the center of the sealing unit 160 . The central guide groove 160a may guide the injection needle 191 toward the center even when the needle 191 is inserted in a different direction. At least three points may be cut in the central guide groove 160a based on the central point. In detail, the incision line may have a 'Y' or 'X' shape, but is not limited thereto, and may be cut in various shapes based on a central point.

Therefore, the central guide groove (160a) has an effect of preventing damage to other points of the sealing part 160 and continuously guiding the injection needle 191 toward the guide tube 140 .

12 is a side cross-sectional view showing a second modified example in which the filter is integrated into the sealing part of the drug injection device according to the present invention.

Referring to FIG. 12 , the sealing unit 160 may further include a sealing filter film 165 for preventing foreign substances from being introduced therein. The sealing filter membrane 165 may be a one-piece type in which the filter and the sealing unit 160 are integrated so that replacement and installation are easy at once. The sealing filter film 165 may have a hinge portion 165a that is folded to surround the upper outer side. The hinge portion 165a may be easily taken out by holding the portion when replacing the sealing filter membrane 165 . Therefore, the sealing filter membrane 165 can prevent the sealing unit 160 from being separated when replacing the consumable sealing unit 160 and can secondary prevent contamination of the sealing unit 160 over time, thereby reducing the side effects of infection. can do it

Meanwhile, the sealing unit 160 may include at least one of the first mixture and the second mixture.

The first mixture contains 55 to 60% by weight of siloxane, silicone, dimethyl and vinyl groups, 25 to 30% by weight of hydrolysis products of silaneamine, 1.1.1-trimethylaminetrimethylsilyl and silica, siloxane silicone, dimethyl and methylvinyl. 5 to 7 wt% of silver may be mixed.

The second mixture contains 55 to 60% by weight of siloxane, silicone, dimethyl and vinyl groups, 25 to 30% by weight of hydrolysis products of silane amine, 1.1.1-trimethylaminetrimethylsilyl and silica, siloxane silicone, dimethyl and methylvinyl. Silver 5 to 7% by weight, silicon siloxane, dimethyl and methyl hydrogen may be mixed in 1 to 5% by weight.

Accordingly, in the sealing unit 160 , the first mixture and the second mixture may satisfy Equation 1 below.

Here, M ₁ means the first mixture, and M ₂ means the second mixture.

If it deviates from the lower limit of Equation 22, the density of the sealing part 160 may be weakened, and thus may be separated and separated over time, and may be hardened or dehydrated when scaling the mixture. And, since there is a lot of bubble generation on the surface of the sealing unit 160 and the injection needle 191 is embedded with silicon particles and can penetrate into the brain parenchyma 5, it may cause side effects after implantation. In addition, when the upper limit of Equation 22 is exceeded, the density of the sealing part 160 becomes strong, so that it is difficult to insert the needle 191 or the needle 191 may be broken. Therefore, when the condition range of Equation 22 is satisfied, the sealing unit 160 has the most appropriate magnification, so it is easy to insert the injection needle 191 into the surface thereof, and the bonding between the silicon particles is strong. There is almost no bubble generation.

13 is a side cross-sectional view showing that the end of the guide tube of the drug injection device according to the present invention is deformed.

Referring to FIG. 13 , the guide tube 140 may have at least one drug injection hole 140a formed on one or both sides of the guide tube 140 so that a drug, that is, a therapeutic agent 195, flows without pooling. The drug injection hole 140a has a circular shape and may be formed in various shapes. In addition, since the inner diameter and outer diameter of the end of the guide tube 140 are formed in a curve, damage to the tissue can be minimized when passing through the brain parenchyma 5 together with the injection needle 191 .

14 is a side cross-sectional view showing the drug injection device of the second embodiment according to the present invention.

Referring to FIG. 14 , the drug injection device 200 of the second embodiment according to the present invention may include a body 210 , a body fixing part 250 and a sealing part 260 . The main body 210 is formed with a sealing receiving hole 210a having a hollow inner center, and is connected to the sealing receiving hole 210a to have a needle insertion hole 310b into which the injection needle 191 is inserted. In addition, the upper portion of the main body 210 may include a support portion 215 , and at least two fastening holes 210b may be formed in the support portion 215 . The sealing hole 210a has a rectangular space that can accommodate the sealing portion 260, and the injection needle 191 can pass through the space. The body fixing part 250 has a fixing hole 250a formed in the center thereof, and a body sealing part 253 formed with a screw thread to be fastened to the inside of the body 210 may be formed on the side thereof. Compared with the drug injection device 100 of FIG. 1 , the injection needle 191 may be inserted in only one direction through the drug injection device 200 . The injection needle 191 may be inserted through the fixing hole 250a through the sealing part 260 into the sealing receiving hole 210a. Therefore, the drug injection device 200 of the second embodiment according to the present invention has a simple structure, so it takes less time for installation and separation and removal, and replacement of the sealing part 260 can be easy.

15 is a side cross-sectional view showing the drug injection device of the third embodiment according to the present invention.

Referring to FIG. 15 , the drug injection device 300 of the third embodiment according to the present invention may include a body 310 , a body fixing part 350 , and a sealing part 360 . The main body 310 is formed with a sealing receiving hole 310a having a hollow inner center, and is connected to the sealing receiving hole 310a so that a needle insertion hole 310b into which the needle 191 is inserted may be formed. In addition, the upper portion of the main body 310 may include a support portion 315 , and at least two fastening holes 310b may be formed in the support portion 315 . The sealing hole 310a has a rectangular space, and the injection needle 191 can pass through the space. Compared with FIG. 14 , the fixing hole 350a is formed in the center of the main body fixing part 350 , and the fixing hole 350a may include a sealing part 360 . A body sealing part 353 formed with a screw thread to be fastened to the inside of the body 310 may be formed on the side of the body fixing part 350 . Compared with the drug injection device 100 of FIG. 1 , the injection needle 191 may be inserted in only one direction through the drug injection device 300 . The injection needle 191 may be inserted through the fixing hole 350a through the sealing part 360 into the sealing receiving hole 310a. Therefore, the drug injection device 300 of the third embodiment according to the present invention has a simple structure, so that when replacing the sealing part 360, only the main body fixing part 350 is fastened and detached, and it can be easily replaced. In addition, the time required for installation and disassembly can be reduced.

16 is a front view showing the drug injection device of the fourth embodiment according to the present invention.

Referring to FIG. 16 , the drug injection device 400 of the fourth embodiment according to the present invention has a main body 410 , a movable part 430 , a main body fixing part 450 , a sealing part 460 and a movable stopper part 480 . may include. The body 410 has a hollow inner center and a movable receiving hole 410a for accommodating the movable part 430 may be formed. In addition, the main body 410 is connected to the movable receiving hole (410a) at the inner lower end, the needle insertion hole (410b) into which the injection needle (191) is inserted may be further formed. In addition, the main body 410 may include an insertion part 413 inserted into the skull 1 and a support part 415 mounted on the skull 1 . At least two fastening holes 410c may be formed in the support 415 . Compared with the drug injection device 100 of Figure 1, the movable part 430 can be rotated left and right based on the central axis CL, so that the injection needle 191 can be guided in the direction of the target point 7 and It is similar in that a hole is formed inside. Therefore, since the sealing part 460 is accommodated between the movable part 430 and the movable stopper part 480 to be double blocked from the outside, infection from external contaminants can be prevented. In addition, the main body fixing part 450 is similar in that the fixing hole 450a into which the drug is injected is formed in the center.

On the other hand, looking at the difference from FIG. 1, the movable part 430 is formed in a hemispherical shape, and after being fastened to face the movable stopper 480, it has a complete spherical shape and can be rotated left and right based on the central axis CL. have. In addition, the body fixing part 450 may have a second fastening hole 450b formed at at least two points, and may be positioned to face the fastening hole 410c of the main body 410 . Accordingly, the coupling between the main body 410 and the main body fixing part 450 may have at least three points to fasten the fastening member 170 .

The above-described embodiments are merely exemplary, and various modifications and equivalent other embodiments are possible from those of ordinary skill in the art to which the present invention pertains. Therefore, the true technical protection scope of the present invention will have to be determined by the technical idea of the invention described in the claims.

1: Skull 3: Scalp
5: cerebral parenchyma (腦實質) 7: target point
10: stereotaxic guide mechanism 13: guide handle
15: position adjustment unit 17: position adjustment handle unit
19: bolt part 100,200,300,400: drug injection device
110,210,310,410: body 110a,410a: movable receiving hole
110b: first fastening hole 113,213,313,413: insertion part
115,215,315,415: support portion 117: fixing projection
130,430: movable part 131: movable body (131)
133: drug injection hole 133a: first receiving part
133b: second receiving unit 140: guide tube
140a: drug injection hole 145: tube connection part
145a: insertion guide hole 150,250,350,450: body fixing part
150a, 250a, 350a, 450a: fixing hole 150b, 450b: second fastening hole
155: mounting unit 157: identification unit
157a: support coupling groove 157b: head receiving groove
157c: protrusion receiving groove 160,260,360,460: sealing part
160a: central guide groove 165: sealing filter membrane
170: fastening member 173: body portion
173a: pressure reducing groove 175: head portion
175a: identification groove 175b: horizontal groove
180,480: movable stopper 180a, 280a, 380a, 480a: needle receiving part
183: movable fastening part 185: position display part
191: needle 195: treatment
210a, 310a: sealing receiving hole 210b, 310b: needle insertion hole
210c, 310c, 410c: fastening hole 253,353: body sealing part
430a: stopper coupling portion P: patient
CL: central axis

Claims (26)

In the drug injection device that is implanted and fixed between the patient's skull and scalp to inject a drug,
a body which is implanted and fixed in contact with the skull and has an internal hole;
a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed;
a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point;
a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted;
a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and
At least two fastening members for fastening the upper part of the main body and the upper part of the body fixing part to the skull,
The body is
A movable accommodating hole for accommodating the movable part is formed therein;
To be located on the upper part of the skull, the support for fixed support to the skull of the patient; and
It includes an insertion part to be inserted into the skull,
A drug injection device, characterized in that it satisfies at least one of the following Conditional Expressions 1 and 2.
<Condition 1>

<Condition 2>

Here, D ₁ is the size of the outer diameter of the insertion portion, D ₂ is the size of the inner diameter of the movable receiving hole, L ₁ is the insertion height of the insertion portion. According to claim 1,
The support part,
A drug injection device, characterized in that at least one fixing protrusion and a first fastening hole are formed to satisfy the following conditional expression (3).
<Condition 3>

Here, D ₃ is the size of the outer diameter of the support, L ₂ is the height of the support. 3. The method of claim 2,
The fixing protrusion,
A drug injection device, characterized in that it satisfies the following Conditional Expression 4.
<Condition 4>

Here, D ₄ is the size of the outer diameter of the fixing projection, L ₃ is the height of the fixing projection. In the drug injection device that is implanted and fixed between the patient's skull and scalp to inject a drug,
a body which is implanted and fixed in contact with the skull and has an internal hole;
a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed;
a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point;
a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted;
a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and
At least two fastening members for fastening the upper part of the main body and the upper part of the body fixing part to the skull,
The body fixing part,
A fixing hole for fixing the outside so that the movable part does not move is formed in the center,
At least one second fastening hole for fixing the fastening member to be inserted into the upper periphery so as not to move is formed,
The fixing hole and the body fixing part is a drug injection device, characterized in that it satisfies at least one of the following Conditional Expression 5 and/or the height of the body fixing part 1mm to 9mm.
<Conditional Expression 5>

Here, D ₅ is the size of the outer diameter of the fixing hole, D ₆ is the size of the outer diameter of the fixing part of the body. 5. The method of claim 4,
The body fixing part,
Identification unit that can be identified because the upper part protrudes into a curved surface; and
The lower part is formed to be concave with a curved surface and includes a support coupling groove that matches the shape of the main body support and facilitates coupling,
The support coupling groove,
At least one protrusion receiving groove coupled to face the fixing protrusion and at least one head receiving groove coupled to face the first fastening hole may be formed, and the following conditional expression 6 is satisfied.
<Conditional Expression 6>

Here, R ₁ means the radius of the support coupling groove. In the drug injection device that is implanted and fixed between the patient's skull and scalp to inject a drug,
a body which is implanted and fixed in contact with the skull and has an internal hole;
a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed;
a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point;
a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted;
a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and
At least two fastening members for fastening the upper part of the main body and the upper part of the body fixing part to the skull,
The movable part,
a movable part located on the fastening member, forming an outer shape of the movable part with a curved surface and capable of position adjustment;
and a drug injection hole in which an internal hole is formed so that a drug is injected into the skull,
The movable part is a drug injection device, characterized in that it satisfies the following conditional expression (7).
<Conditional Expression 7>

Here, D ₈ is the size of the outer diameter of the movable part, and L ₅ is the height of the movable part. 7. The method of claim 6,
The movable part,
A drug injection device, characterized in that it is formed in a spherical shape consisting of a sphericity of less than 0.03mm. 7. The method of claim 6,
The drug injection hole,
a first accommodating part accommodating the sealing part located in the inner hole of the movable part; and
It is connected to the first accommodating part and includes a second accommodating part located at the lower inside of the movable part and accommodating the injection needle inserted during drug injection,
A drug injection device, characterized in that each of the first accommodating part and the second accommodating part satisfy at least one of the following Conditional Expressions 8 and 9.
<Conditional Expression 8>

<Conditional Expression 9>

Here, V ₁ is the volume of the internal space of the first accommodating part, and D ₉ is the size of the inner diameter of the second accommodating part. 9. The method of claim 8,
The first receiving unit,
The side surface is formed with a thread from the start of the inner hole of the movable part to the point where the sealing part is accommodated to the point where it is accommodated,
A drug injection device, characterized in that the height at which the screw thread is formed satisfies the following conditional expression 10.
<Conditional Expression 10>

Here, L ₅ denotes the total height of the first accommodating part and the second accommodating part, and L _5a denotes the height at which the screw thread is formed. In the drug injection device that is implanted and fixed between the patient's skull and scalp to inject a drug,
a body which is implanted and fixed in contact with the skull and has an internal hole;
a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed;
a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point;
a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted;
a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and
At least two fastening members for fastening the upper part of the main body and the upper part of the body fixing part directly to the skull and fastening them;
The sealing part,
The sealing part and the movable stopper part, drug injection device, characterized in that it satisfies at least one of the following Conditional Expressions 11 and 12.
<Conditional Expression 11>

<Conditional Expression 12>

Here, D ₁₀ is the size of the outer diameter of the sealing part, D ₁₁ is the size of the outer diameter of the movable stopper, L ₆ is the height of the sealing portion, L ₇ is the height of the movable stopper. 11. The method of claim 10,
The sealing part,
A drug injection device, characterized in that made of a silicone material. 11. The method of claim 10,
The movable stopper,
an injection needle receiving part having a hole in the center into which the injection needle is injected;
a position display unit including the needle receiving unit therein and positioned outside the movable unit;
The drug injection device, characterized in that it is connected to the position display unit, and includes a movable fastening member that is threaded on the outside and is fastened with a male and female screw thread to the drug injection hole. 13. The method of claim 12,
The needle receiving unit,
A drug injection device, characterized in that it satisfies the following conditional expression 13.
<Conditional Expression 13>
A ₁ ≥ A ₂
Here, A ₁ denotes an angle of the upper end of the needle accommodating part among angles forming left and right with respect to the central axis, and A ₂ denotes an angle of the middle part of the needle accommodating part. 13. The method of claim 12,
The position display unit,
A drug injection device, characterized in that it satisfies the following condition 14.
<Conditional Expression 14>

Here, L ₇ means the total height of the movable stopper, and L _7a means the height of the position display part. In the drug injection device that is implanted and fixed between the patient's skull and scalp to inject a drug,
a body which is implanted and fixed in contact with the skull and has an internal hole;
a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed;
a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point;
a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted;
a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and
The fastening member,
a body portion that is implanted and fixed in the skull; and
and a head part connected to the body part and mounted thereon;
The drug injection device, characterized in that the body part and the head part satisfy at least one of the following Conditional Expressions 15 and 16.
<Conditional Expression 15>

<Conditional Expression 16>

Here, D ₁₁ is the size of the outer diameter of the body, D ₁₂ is the outer diameter of the head, L ₉ is the length of the body, L ₈ is the length of the head. 16. The method of claim 15,
The head part,
a horizontal groove positioned in the center so as to be horizontally fastened to the fastening mechanism when fastening; and
It includes an identification groove formed so as to be identifiable linearly dividing the horizontal axis and the vertical axis based on the horizontal groove,
The horizontal groove and the identification groove are drug injection device, characterized in that it satisfies the following condition 17.
<Condition 17>

Here, D ₁₃ means the width of the identification groove, and D _8a means the size of the outer diameter of the horizontal groove. 16. The method of claim 15,
The body part,
It is placed and fixed in the skull and the thread is tapered to the end.
A drug injection device, characterized in that at least one pressure reducing groove satisfying the following condition 18 is formed.
<Conditional Expression 18>

Here, D ₉ means the length of the body portion, and L _9a means the length of the portion in which the pressure reducing groove is formed. In the drug injection device that is implanted and fixed between the patient's skull and scalp to inject a drug,
a body which is implanted and fixed in contact with the skull and has an internal hole;
a body fixing part having an inner hole adjacent to the body and facing the body to be coupled and fixed;
a movable part positioned between the main body and the main body fixing part and having a drug injection hole formed in the center to change the direction to the target point;
a sealing part which is provided to seal the drug injection hole of the movable part and into which an injection needle for injecting a drug is inserted;
a movable stopper positioned above the sealing part to seal and fix the movable part and to block the sealing part from being separated from the outside, and to identify the implantation position of the drug injection device and guide the repeated administration point; and
At least two fastening members for fastening the upper part of the main body and the upper part of the body fixing part directly to the skull and fastening them;
The drug injection device,
It is connected to the movable part and is inserted into the brain parenchyma to a position close to the target, further comprising a guide tube for guiding the injection needle for injecting the drug into the target point in the target direction,
The guide tube is
A drug injection device, characterized in that it satisfies the following conditional expression 19.
<Conditional Expression 19>

Here, D _14a means the size of the inner diameter of the guide tube, and D _14b means the size of the outer diameter of the guide tube. 19. The method of claim 18,
The guide tube is
Drug injection device, characterized in that it comprises a length of 10mm to 300mm. 19. The method of claim 18,
It is mounted on the lower end of the drug injection hole and connects between the movable part and the guide tube, and further comprises a tube connection part in which an insertion guide hole extending from the inside of the guide tube is formed,
The tube connection portion is a drug injection device, characterized in that it satisfies at least one of the following Conditional Expression 20 and Conditional Expression 21.
<Conditional Expression 20>

<Conditional Expression 21>

Here, D ₁₅ is the size of the outer diameter of the tube connection part, D ₁₆ is the size of the inner diameter of the tube connection part, and L ₁₀ is the height of the tube connection part. 19. The method of claim 18,
The guide tube is
At least one drug injection hole is formed on one side or both sides so that the drug flows without accumulating, and the inner and outer diameters of the guide tube end are formed in a curved shape to minimize tissue damage when inserted into the skull. injection device. 22. The method according to any one of claims 1 to 21,
The guide tube is
Drug injection device, characterized in that the maximum angle deformed by rotation from the central axis to the left and right target points on the basis of the plane in contact with the skull is within 60˚. 22. The method according to any one of claims 1 to 21,
The drug injection device,
At least one of the main body, the main body fixing part, the movable part, the movable stopper part and the guide tube is made of polyether ether ketone. 22. The method according to any one of claims 1 to 21,
The sealing part,
Further comprising a filter to prevent the input of foreign substances inside,
A drug injection device comprising an integrated sealing filter membrane that is easy to replace and install at once by integrating the filter and the sealing part. 22. The method according to any one of claims 1 to 21,
The sealing part,
55 to 60 wt% of siloxane, silicone, dimethyl and vinyl groups, 25 to 30 wt% of silane amine, 1.1.1-trimethylaminetrimethylsilyl and silica hydrolysis products, 5 to 7 wt% of silicon siloxane, dimethyl and methylvinyl A first mixture mixed by weight %; and
55 to 60 wt% of siloxane, silicone, dimethyl and vinyl groups, 25 to 30 wt% of silane amine, 1.1.1-trimethylaminetrimethylsilyl and silica hydrolysis products, 5 to 7 wt% of silicon siloxane, dimethyl and methylvinyl Weight %, siloxane silicone, dimethyl and methyl hydrogen is a drug injection device comprising a second mixture of 1 to 5% by weight. 22. The method according to any one of claims 1 to 21,
The sealing part,
The drug injection device, characterized in that the first mixture and the second mixture satisfy the following conditional expression 22.
<Conditional expression 22>

Here, M ₁ means the first mixture, and M ₂ means the second mixture.

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