KR102380848B1 - Method of Manufacturing Implant Cartridge for Treating Macular Degeneration - Google Patents

Abstract

The present invention relates to a method for manufacturing an implant cartridge for the treatment of macular degeneration, and more particularly, to manufacturing an implant cartridge used for inserting an implant in which a biodegradable resin and a therapeutic agent are mixed into a human eye to treat a macular degeneration disease. it's about how to
The method for manufacturing an implant cartridge for treatment of macular degeneration according to the present invention has an advantage in that the implant cartridge can be effectively manufactured with high productivity and high quality.

Description

Method of Manufacturing Implant Cartridge for Treating Macular Degeneration

The present invention relates to a method for manufacturing an implant cartridge for the treatment of macular degeneration, and more particularly, to manufacturing an implant cartridge used for inserting an implant in which a biodegradable resin and a therapeutic agent are mixed into a human eye to treat a macular degeneration disease. It's about how to do it.

The nerve tissue located in the center of the inner retina of the eye is called the macula. Most of the photoreceptor cells are gathered here, and since the center of the macula is where the image of an object is formed, the macula plays a very important role in vision.

Macular degeneration is a disease in which the function of the macula decreases due to aging, genetic factors, toxicity, inflammation, etc.

As a method of treating macular degeneration, methods such as taking therapeutic drugs or radiation, antibody injection, or steroid injection are used.

Antibody injection therapy is the most widely used method for the treatment of macular degeneration. It is a treatment method that improves visual acuity by injecting an anti-vascular endothelial growth factor antibody (Anti-VEGF antibody) into the eyeball to regress new blood vessels without destroying retinal photoreceptors.

Injection treatment using drugs is divided into fixed treatment in which an injection is administered once every 1 to 2 months, and customized treatment in which an injection is administered only when eyesight deteriorates after a monthly check-up. Difficulty arises in having to receive injections about twice.

In addition, since it is necessary to directly inject into the eye during antibody injection treatment, there is a problem in that the patient's discomfort is very large and the procedure is not simple.

In order to solve this inconvenience, a method of using a sustained release formulation is recently used. When an implant made by mixing a biodegradable resin with a therapeutic agent is inserted into the patient's eye, long-term continuous and quantitative drug release is possible with just one insertion, which is very advantageous in terms of time and cost and reduces the patient's pain. There is this.

Although such a drug implant has a very good function, the solid implant has a small size as well as low strength and strong brittleness, so it is easily broken even with a small force.

Accordingly, there is a need for a method of inserting an implant having the above-described characteristics into a very small, needle-shaped, thin cannula having an outer diameter within several hundreds of micrometers to manufacture the implant in the form of a cartridge.

When an implant cartridge of this type is manufactured, the implant is inserted into the patient's eye using a separate surgical tool, thereby being used as a means of treating macular degeneration.

Laid-open Patent Publication No. 10-2019-0121786 (2019.10.28.)

The present invention has been devised to solve the necessity as described above, and a method of manufacturing an implant cartridge by effectively inserting a micro-sized implant formed in a semi-solid state by mixing a therapeutic drug and a biodegradable resin into a cannula. intended to provide

The method for manufacturing an implant cartridge for macular degeneration treatment of the present invention for achieving the above object is to insert an implant formed in a semi-solid state by mixing a macular degeneration treatment drug and a biodegradable resin in a cylindrical cannula to achieve the macular degeneration treatment implant. A method of manufacturing an implant cartridge for the treatment of macular degeneration for manufacturing a cartridge, the method comprising: (a) receiving the cannula and fixing it by a cannula fixing module; (b) receiving the implant and clamping it using a grip module; (c) assembling the implant cartridge by moving the grip module by a grip transport module that transports the grip module to align the position of the implant with respect to the cannula and inserting the implant with respect to the cannula; and (d) discharging the implant cartridge by the step (c).

The method of manufacturing an implant cartridge for the treatment of macular degeneration according to the present invention has an advantage in that the implant cartridge can be effectively manufactured with high productivity and high quality.

1 is a schematic diagram of an apparatus for manufacturing an implant cartridge for treatment of macular degeneration for carrying out a method of manufacturing an implant cartridge for treatment of macular degeneration according to an embodiment of the present invention.
FIG. 2 is a cross-sectional view of a portion of the apparatus for manufacturing an implant cartridge for treating macular degeneration shown in FIG. 1 .
Figure 3 is a perspective view showing an example of a cannula tray used to practice the implant cartridge manufacturing method for the treatment of macular degeneration according to the present invention.
4 to 6 are cross-sectional views of a cannula used for carrying out a method for manufacturing an implant cartridge for treating macular degeneration according to the present invention.

Hereinafter, a method for manufacturing an implant cartridge for treating macular degeneration according to an embodiment of the present invention will be described with reference to FIGS. 1 to 6 .

1 is a schematic view of an implant cartridge manufacturing apparatus for macular degeneration treatment for carrying out a method for manufacturing an implant cartridge for macular degeneration treatment according to an embodiment of the present invention, and FIG. 2 is an implant cartridge manufacturing for macular degeneration treatment shown in FIG. It is a cross-sectional view of a part of the device, and FIG. 3 is a perspective view showing an example of a cannula tray used to implement a method for manufacturing an implant cartridge for treating macular degeneration according to the present invention.

First, an apparatus for manufacturing an implant cartridge for treatment of macular degeneration for carrying out the method of manufacturing an implant cartridge for treatment of macular degeneration of the present invention will be described.

The apparatus for manufacturing an implant cartridge for treating macular degeneration includes a cannula fixing module 700 , a grip module 300 , a grip transport module 400 , and a control unit.

The cannula 110 is supplied through the cannula tray 200 of the form as shown in FIG. The cannula tray 200 includes a jig body 201 in the form of a hexahedral box. A plurality of insertion holes 210 are formed on the upper surface of the jig body 201 . The cannula 110 is inserted into such an insertion hole 210 and supplied. The jig body 201 of the cannula tray 200 is formed with a plurality of suction passages 220 leading to the lower surface. Each suction flow path 220 is formed to communicate with the insertion hole (210). That is, the cannula tray 200 is formed so that the vacuum negative pressure can be transmitted to the insertion hole 210 through the suction passage 220 .

The cannula 110 inserted and mounted in the cannula tray 200 is formed in a cylindrical needle shape. 4 to 6 show an example of the implant cartridge 100 in a state in which the implant 120 is inserted into the cannula 110 of three different types, respectively.

The cannula 110 of the implant cartridge 100 shown in FIG. 4 has a structure in which a side hole 112 is formed at the lower end. A side hole 112 formed to pass through the cannula body 111 from the side is formed in the waist portion of the cannula body 111, and an O-ring 10 is seated in the side hole 112, so that the cannula body 111 passes through the cannula body ( 111) is installed.

In the implant cartridge 100 shown in FIG. 5 , a side hole 113 formed to pass through the cannula body 111 from the side is formed in the waist portion of the cannula body 111 , and the side hole 114 is formed through the side hole 114 . A locking stopper 113 is formed so as to protrude toward the inner diameter of the cannula body 111 . The locking stopper 113 has a structure in which a part of the cannula body 111 is bent inward in the process of forming the side hole 113 .

The implant cartridge 100 shown in FIG. 6 has a structure in which a protrusion-shaped stopper 114 that is formed to protrude from the inner wall surface is formed on the inner diameter portion of the cannula body 111 .

The cannula 110 having such a structure is supplied in the form of being inserted into the insertion hole 210 of the cannula tray 200 described above, respectively.

Such a cannula tray 200 is mounted and fixed to the cannula fixing module 700 .

The grip module 300 is configured to clamp the implant 120 for insertion into the cannula 110 . In the present embodiment, the grip module 300 has a structure including a voice coil motor 310 and a collet 320 . The voice coil motor 310 (VCM: Voice Coil Motor) operates by moving the iron core forward and backward by electromagnetic force generated by power applied to the coil. The grip module 300 is configured to clamp the implant 120 by connecting the collet 320 to the voice coil motor 310 . 2 shows an example of the grip module 300 . A plurality of grip members 321 are rotatably installed about a horizontal axis at the lower portion of the voice coil motor 310 and are arranged at equal angular intervals along the circumferential direction. The grip member 321 may have three or four configurations as needed. When the operation unit 311 connected to each grip member 321 is raised and lowered by the voice coil motor 310, each grip member 321 rotates so that the lower end of the grip member 321 becomes closer or farther away from each other in the radial direction. do. By such an operation method, the grip module 300 may clamp the upper end of the implant 120 .

The grip transport module 400 transports the grip module 300 in a horizontal direction and a vertical direction.

The camera 500 is installed on the upper side of the cannula fixing module 700 to photograph the position of the cannula 110 fixed to the cannula fixing module 700 . The controller uses the image captured by the camera 500 to determine the position of the cannula 110 and controls the operation of the grip transfer module 400 based on the position of the cannula 110 .

Referring to FIG. 1 , the suction module 600 is disposed below the cannula fixing module 700 . The suction module 600 is provided with a pneumatic pump, and generates a vacuum negative pressure by the operation of the pneumatic pump. The suction module 600 transfers the suction pipe 601, connects it to the suction flow path 220 on the lower surface of the cannula tray 200, and delivers negative pressure to the cannula 110 inserted into the insertion hole through the suction flow path 220. do.

Hereinafter, a process of carrying out a method for manufacturing an implant cartridge for macular degeneration treatment using an implant cartridge manufacturing apparatus for macular degeneration treatment of the configuration as described above will be described.

First, the cannula 110 is supplied and fixed by the cannula fixing module 700 (step (a)). The cannula 110 is supplied while being mounted on the cannula tray 200 having the structure as described above, and the cannula tray 200 is mounted and fixed to the cannula fixing module 700 .

In this state, the camera 500 captures the position of each cannula 110 mounted on the cannula tray 200 and transmits it to the control unit, and the control unit analyzes the photographed image and puts it on the cannula tray 200 . The position of each mounted cannula 110 is calculated.

In this way, in a state where the position of the cannula 110 is grasped, the grip module 300 clamps the implant 120 for insertion into the cannula 110 (step (b)). The implant 120 is formed in a semi-solid state by mixing a drug for treating macular degeneration and a biodegradable resin, and is configured in the form of a long and thin rod. Since the implant 120 is made of a brittle material, it is broken when an excessive force is applied. The control unit may effectively control the force of the collet 320 clamping the implant 120 by controlling the power transmitted to the voice coil motor 310 of the grip module 300 .

In this way, in a state in which the grip module 300 clamps the implant 120 , the grip transfer module 400 moves the grip module 300 to align the position of the implant 120 with respect to the cannula 110 and Assemble the implant cartridge 100 by inserting the implant 120 with respect to (110) (step (c)).

Step (c) is, as described above, the step (c-1) of determining the position of the cannula 110 by the camera 500), and the cannula 110 grasped by the camera 500 ) by controlling the grip transfer module 400 according to the position of the implant 120 into the cannula 110 (step (c-2)).

In this way, in the process of inserting the implant 120 into the cannula 110 using the grip transfer module 400 , the suction module 600 described above may help.

The suction module 600 transmits negative pressure through the suction passage 220 of the cannula tray 200 . A negative pressure may be simultaneously transmitted to all suction flow paths 220 of the cannula tray 200, and the suction pipe 601 is sequentially connected to the suction flow path 220 of the cannula tray 200 as shown in FIG. Thus, the negative pressure may be sequentially transmitted to each of the suction passages 220 .

In this embodiment, a case in which the negative pressure is sequentially transmitted to each suction flow path 220 will be described as an example.

In this way, in a state in which the negative pressure is transmitted to the suction passage 220 and the inner diameter of the cannula 110 by the suction module 600 , the grip transfer module 400 and the grip module 300 transfer the implant 120 to the cannula 110 . ) to the upper inlet part.

When the lower end of the implant 120 approaches the upper end of the cannula 110 , the end of the implant 120 fits the inner diameter of the cannula 110 by the air flow due to the negative pressure transmitted to the cannula 110 . It can be guided to the correct position. The inner diameter of the cannula 110 and the outer diameter of the implant 120 are very small, tens to several hundreds of micrometers, and the implant 120 is a semi-solid material so that its outer shape is not accurately and precisely maintained. As shown, if the flow of air by the suction module 600 is used, there is an advantage of receiving auxiliary assistance in controlling the position of the lower end of the implant 120 . In this way, the quality and productivity of the implant cartridge 100 assembly process can be increased.

In addition, it is possible to control the position of the lower end of the implant 120 by the action of negative pressure by the suction module 600, and the process of inserting the implant 120 into the cannula 110 can be performed more effectively. . The implant 120 is pushed downward by the grip module 300 and the grip transfer module 400 from the upper side, and the implant 120 is pulled downward by the negative pressure inside the cannula 110 from the lower side. As such, the grip transfer module 400 and the suction module 600 interact with each other so that the implant 120 can be smoothly inserted into the inner diameter of the cannula 110 from the outside and the inside of the cannula 110, respectively, so that the overall It has the advantage of increasing the productivity of the process.

In addition, since the control unit monitors the pressure measured by the pressure gauge installed in the suction module 600 , there is an advantage in that the process can be more precisely controlled and the quality of the process can be improved. When the lower end of the implant 120 starts to be inserted into the upper end of the cannula 110 while the pneumatic pump is operating, the upper end of the cannula 110 is blocked, so the pressure inside the suction flow path 220 drops rapidly. . When the control unit senses such a change in pressure from the pressure gauge, the control unit may control the grip transfer module 400 while grasping such a state of the implant 120 . If such a method is used, there is an advantage in that it is possible to prevent the occurrence of process defects that may occur due to the lowering of the implant 120 while the position of the lower end of the implant 120 deviates from the cannula 110 .

If the implant 120 continues to descend in a state in which the lower end of the implant 120 is inserted into the cannula 110 , the implant 120 smoothly cannula 110 with the help of negative pressure by the suction module 600 . inserted inside.

When the cannula 110 is inserted up to the portion adjacent to the upper portion of the implant 120 , the grip module 300 releases the clamping of the implant 120 . In this state, the implant 120 is descended only by the negative pressure inside the cannula 110 . The implant 120 descending from the inside of the cannula 110 by the negative pressure is caught by the stopper 114 and does not go down any further.

The cannula 110 of the form shown in FIG. 4 is caught on the O-ring 10 so that the implant 120 does not descend any more. As such, when the implant 120 is caught on the O-ring 10, the pressure inside the suction passage 220 is further decreased, and the control unit detects this through a pressure gauge to stop the operation of the suction module 600. The implant cartridge 100 of the structure as shown in FIG. 4 is used after removing the O-ring 10 .

In the cannula 110 of the form shown in FIG. 5 , the implant 120 is caught by the stopper 113 and does not go down any more.

6 is a structure in which a protrusion-shaped stopper 114 is formed on the inner diameter of the cannula body 111 . This stopper 114 may be formed of a biodegradable resin and may be inserted into the body together with the implant 120 when the implant cartridge 100 is used later. Alternatively, after the insertion of the implant 120 into the cannula 110 is completed, the protrusion-shaped stopper 114 may be removed by a separate process.

The process of assembling the implant cartridge 100 is repeated by sequentially inserting the implant 120 in the same manner as described above for all the cannulas 110 mounted on the cannula tray 200 .

As such, when the insertion operation of the implant 120 for all the cannula 110 mounted on the cannula tray 200 is completed, the implant cartridge 100 is discharged by discharging the cannula tray 200 ( (d) step).

Meanwhile, when a piezoelectric element or a load cell is installed in the grip member 321 of the grip module 300 described above, it is possible to sense the clamping force of the implant 120 by the grip module 300 . As described above, when the control unit detects the clamping force of the grip module 300 in real time and the operation proceeds, the implant 120 starts to be inserted into the cannula 110 without the aid of the pressure gauge described above and the implant 120 ) is caught on the stopper 114 inside the cannula 110 , and the control unit can operate the grip module 300 and the grip transfer module 400 in an appropriate way according to the situation.

In the above, the present invention has been described with preferred examples, but the scope of the present invention is not limited to the above-described and illustrated forms.

For example, although the implant cartridge 100 of three structures has been described with reference to FIGS. 4 to 6 above, the structure of the cannula 110 used to manufacture the implant cartridge 100 is shown in the drawings. In addition to the shape, it may be variously modified.

In addition, although an example of the cannula tray 200 has been described with reference to FIG. 3 above, the structure of the cannula tray for mounting and transporting the cannula 110 can be variously modified.

Likewise, it is possible to use grip modules and collets of various structures other than those shown in FIG. 2 .

In addition, although the process of inserting the implant 120 into the cannula 110 with the help of the negative pressure by the suction module 600 by step (e) has been described above, macular degeneration is a method that omits step (e). It is also possible to practice a method of manufacturing a therapeutic implant cartridge.

100: implant cartridge 110: cannula
120: implant 111: cannula body
112: side hole 10: O-ring
113: jam stopper 115: side hole
114: stopper 200: cannula tray
210: insertion hole 220: suction flow path
300: grip module 310: voice coil motor
320: collet 321: grip member
400: grip transport module 500: camera
600: suction module 700: cannula fixation module

Claims (9)

In the method for manufacturing an implant cartridge for macular degeneration treatment, the implant cartridge for macular degeneration treatment is manufactured by inserting an implant formed in a semi-solid state by mixing a macular degeneration treatment drug and a biodegradable resin in a cylindrical cannula,
(a) receiving the cannula and fixing it by a cannula fixing module;
(b) receiving the implant and clamping it using a grip module;
(c) assembling the implant cartridge by moving the grip module by a grip transport module that transports the grip module to align the position of the implant with respect to the cannula and inserting the implant with respect to the cannula; and
(d) discharging the implant cartridge by the step (c); macular degeneration treatment implant cartridge manufacturing method comprising a. According to claim 1,
The step (b) is performed using the grip module including a voice coil motor and a collet connected to the voice coil motor and operated to clamp the implant. 3. The method of claim 2,
Step (c) is,
(c-1) capturing the position of the cannula with a camera to determine the position of the cannula;
(c-2) controlling the grip transfer module according to the position of the cannula detected by the camera to insert the implant into the cannula. 4. The method of claim 3,
In the step (a), the cannula is inserted into each of the plurality of insertion holes of the cannula tray using a jig body and a cannula tray having a plurality of insertion holes formed on the upper surface of the jig body. receiving the cannula together with the cannula tray,
Steps (b) and (c) are performed by sequentially clamping the implant by the grip module for each cannula mounted on the cannula tray. 5. The method of claim 4,
The cannula tray further comprises a plurality of suction passages formed in the jig body to be respectively connected to the plurality of insertion holes of the jig body,
(e) generating a negative pressure in one of the plurality of suction passages connected to at least one of the plurality of insertion holes of the cannula tray by the suction module to form a negative pressure in the inner diameter of the cannula mounted in the insertion hole further comprising;
In the step (c), the implant cartridge manufacturing method for macular degeneration is performed to assemble the implant cartridge with the help of the negative pressure formed in the inner diameter of the cannula while performing the step (e). 6. The method of claim 5,
The suction module further comprises a pressure gauge for measuring the pressure of the negative pressure transmitted to the suction passage of the cannula tray,
The step (c) is a method of manufacturing an implant cartridge for treating macular degeneration while monitoring the change in pressure measured by the pressure gauge of the suction module. 7. The method of claim 6,
In the step (c), when the pressure measured by the pressure gauge of the suction module starts to drop rapidly, the implant cartridge manufacturing method for the treatment of macular degeneration is grasped as starting to be inserted into the cannula. 8. The method according to any one of claims 1 to 7,
The cannula is
An implant cartridge for treating macular degeneration comprising a cylindrical cannula body, a side hole formed in the cannula body to pass through the cannula body from the side, and an O-ring mounted on the cannula body to be seated in the side hole. manufacturing method. 8. The method according to any one of claims 1 to 7,
The cannula is
Macular disease comprising a cylindrical cannula body, a side hole formed in the cannula body to pass through the cannula body from the side, and a locking stopper formed to protrude to the inner diameter of the cannula body through the side hole A method for manufacturing an implant cartridge for sexual treatment.

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