WO2024058390A1

WO2024058390A1 - Aqueous humor outflow device insertion apparatus for inserting aqueous humor outflow device for glaucoma treatment into eye

Info

Publication number: WO2024058390A1
Application number: PCT/KR2023/010112
Authority: WO
Inventors: 김태우
Original assignee: 서울대학교병원
Priority date: 2022-09-13
Filing date: 2023-07-14
Publication date: 2024-03-21
Also published as: KR20240036366A

Abstract

Provided is an aqueous humor outflow device insertion apparatus which enables an aqueous humor outflow device to be accurately inserted into a desired location within the eye. The aqueous humor outflow device insertion apparatus comprises: a cylindrical housing; an injection needle which accommodates an aqueous humor outflow device therein and protrudes or retracts in the longitudinal direction of the housing through a sliding hole formed through the top of the housing, to move between a first position and a second position; and a support having the lower end fixed to the housing and the upper end inserted into the injection needle. When the injection needle protrudes through the sliding hole to be placed in the first position, the support supports the lower part of the aqueous humor outflow device accommodated in the injection needle. When the injection needle retracts through the sliding hole to move to the second position from the first position, the aqueous humor outflow device is exposed to the outside by the movement of the injection needle and the support by the support.

Description

Aqueous outflow device insertion device for inserting an aqueous outflow device for the treatment of glaucoma into the eye.

The present invention relates to an aqueous outflow device insertion device for inserting into the eye an aqueous outflow device capable of draining aqueous humor from the anterior chamber into the outer conjunctival space or subconjunctival space in the treatment of glaucoma.

Aqueous humor or aqueous humor refers to the transparent liquid that fills the area between the cornea and the iris of the eye (this is called the 'anterior') and between the iris and the lens (this is called the 'posterior') and has properties similar to lymph. . The aqueous humor serves to maintain pressure within the eye.

Meanwhile, glaucoma is a progressive optic neuropathy that causes abnormalities in the function of the optic nerve and causes visual field defects. The main cause of glaucoma is damage to the optic nerve due to increased intraocular pressure. Intraocular pressure refers to the pressure of the eye (eyeball), and is mainly determined by the balance of aqueous humor circulation. Aqueous humor is produced little by little every day in the ciliary body behind the iris, and the amount produced flows out of the eye through circulation. If too much aqueous humor is produced or circulation flow is disrupted and outflow is reduced, the pressure inside the eye rises. Through this process, intraocular pressure rises, causing glaucoma. If this increase in intraocular pressure continues, permanent vision loss may occur. Additionally, in cases where the optic nerve is weak, damage to the optic nerve due to pressure may occur even within the normal range of intraocular pressure, resulting in glaucoma.

Since glaucoma disease begins with damage to the optic nerve, it is difficult to restore already damaged areas, so the goal of all treatments is to prevent further damage. Treatment to lower intraocular pressure with drugs is usually performed first, but if intraocular pressure is not controlled even with the use of various drugs or drugs cannot be used due to side effects from drugs, surgical treatments such as trabeculectomy and aqueous outflow device insertion are applied. .

Recently, there have been various attempts to use microtubes as aqueous humor outflow devices to simplify and ensure safety of surgery. However, because the length of microtubules is only a few millimeters and the diameter is only a few hundred um, it is technically very difficult to accurately insert an aqueous humor outflow device into a specific location within the eye.

The problem to be solved by the present invention is to provide an aqueous humor outflow device insertion device that can accurately insert the aqueous humor outflow device into a desired location within the eye.

The problems to be solved by the present invention are not limited to the problems mentioned above, and other problems not mentioned can be clearly understood by those skilled in the art from the description below. will be.

An aqueous outflow device insertion device according to an embodiment of the present invention for achieving the above object is an aqueous outflow device insertion device for inserting an aqueous humor outflow device for glaucoma treatment into the eye, comprising: a cylindrical housing; an injection needle that stores the waterproof outflow mechanism therein and is drawn out or drawn in the longitudinal direction of the housing through a sliding hole formed at the top of the housing and moves between a first position and a second position; And the lower end is fixed to the housing and the upper end includes a support inserted into the injection needle. Here, when the injection needle is pulled out through the sliding hole and located in the first position, the support supports the lower part of the aqueous humor outflow mechanism accommodated in the injection needle. When the injection needle is introduced through the sliding hole and moves from the first position to the second position, the aqueous humor outflow mechanism is exposed to the outside by movement of the needle and support of the support.

A slot formed on a side of the housing may extend along the longitudinal direction. A lever connected to the injection needle and protruding to the outside through the slot can move along the slot along with the injection needle.

The elastic portion disposed within the housing between the upper end of the housing and the lever may provide an elastic force to the needle to move the needle from the first position to the second position. When the injection needle is located in the first position, a locking portion that prevents movement of the lever may be formed in the slot.

A buffer disposed within the housing between the lower end of the housing and the lever may prevent rapid movement of the needle from the first position to the second position.

The fixing part coupled to the bottom of the support may be coupled to the bottom of the housing.

The support portion protruding from the side of the housing is seated on the surface of the eye and can prevent the housing from shaking when the injection needle is inserted.

Details of other embodiments are included in the detailed description and drawings.

As described above, according to the aqueous humor outflow device insertion device according to the present invention, when the injection needle is pulled out from the housing and placed in the first position, the needle pierces the sclera of the eye with the aqueous humor outflow device housed therein and is positioned at a specific location. can be accurately inserted into . Next, when the needle is inserted into the housing and moved to the second position with the support supporting one end of the aqueous humor outflow mechanism within the needle, the aqueous humor outflow mechanism may naturally be exposed to the outside and remain in the specific position. Therefore, by using the aqueous humor outflow device insertion device of the present invention, an aqueous humor outflow device made of microtubes can be conveniently and accurately inserted into a specific location within the eye.

When the lever connected to the injection needle is located in the locking portion of the housing with the injection needle positioned in the first position, the needle can stably pierce the sclera of the eye because the longitudinal movement of the injection needle is limited.

When the lever is released from the locking portion, the elastic portion automatically moves the needle from the first position to the second position, so the operator does not need to apply separate force to move the needle. Additionally, the buffer portion located on the opposite side of the elastic portion can prevent the needle from rapidly moving from the first position to the second position and induce a smooth and gentle movement.

If the operator's hand holding the housing trembles while the injection needle is moving from the first position to the second position, the aqueous outflow mechanism may be damaged. To prevent this, a support is formed on the side of the housing, and when the needle moves to the second position while the support is seated on the surface of the eye, shaking of the housing due to the operator's shaking and damage to the aqueous outflow mechanism can be effectively prevented. there is.

Figure 1 is a perspective view showing a device for inserting a waterproof outflow device according to a first embodiment of the present invention.

Figure 2 is an exploded perspective view showing the waterproof outflow device insertion device of Figure 1.

Figure 3 is a longitudinal cross-sectional view of the waterproof outflow device insertion device of Figure 1.

Figure 4 is a perspective view showing a case where the injection needle of the waterproof outflow device insertion device according to the first embodiment of the present invention is located in the second position.

Figure 5 is a cross-sectional view showing an eye into which an aqueous humor outflow device has been inserted by the aqueous humor outflow device insertion device of Figure 1.

Figure 6 is a cross-sectional view cut in the longitudinal direction of the waterproof outflow device insertion device according to the second embodiment of the present invention.

The advantages and features of the present invention and methods for achieving them will become clear by referring to the embodiments described in detail below along with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below and will be implemented in various different forms. The present embodiments only serve to ensure that the disclosure of the present invention is complete and that common knowledge in the technical field to which the present invention pertains is not limited. It is provided to fully inform those who have the scope of the invention, and the present invention is only defined by the scope of the claims. Like reference numerals refer to like elements throughout the specification.

Hereinafter, a device for inserting a waterproof outflow device according to a first embodiment of the present invention will be described in detail with reference to FIGS. 1 to 3. Figure 1 is a perspective view showing a device for inserting a waterproof outflow device according to a first embodiment of the present invention. Figure 2 is an exploded perspective view showing the waterproof outflow device insertion device of Figure 1. Figure 3 is a longitudinal cross-sectional view of the waterproof outflow device insertion device of Figure 1.

The aqueous humor outflow device insertion device 300 according to the first embodiment of the present invention is a device for inserting the aqueous humor outflow device 200 for glaucoma treatment into the eye 100, and includes a housing 310, an injection needle 320, and a lever. It includes (324), a support unit (342), an elastic unit (330), a buffer unit (340), and a fixing unit (350). Here, the aqueous humor outflow mechanism 200 has an overall tube shape and forms a passage for outflow of aqueous humor 60 from the front 25 of the eyeball 100 to the outer space or subconjunctival space of the conjunctiva 30. The waterproof outflow device 200 may be made of a hollow fiber membrane, for example, polyether sulfone (PES), polytetrafluoroethylene (PTFE), or polyvinylidene difluoride (PVDF). As another example, the waterproof outflow device 200 may be made of silicone, collagen gel, poly(methyl methacrylate), or poly(styrene-block-isobutylene-block-styrene).

The housing 310 has an overall cylindrical shape and may be made of, for example, plastic. A sliding hole 312 is formed at the top of the housing 310. The sliding hole 312 guides the longitudinal movement of the injection needle 320, and the inner diameter of the sliding hole 312 may be larger than or equal to the outer diameter of the injection needle 320. A fixing part 350 is coupled to the bottom of the housing 310. For example, the fixing part 350 may be coupled to the bottom of the housing 310 by screwing.

The slot 314 formed on the side of the housing 310 extends along the longitudinal direction of the housing 310. The slot 314 may be formed as a gap extending along the longitudinal direction from the side of the housing 310.

The injection needle 320 accommodates the waterproof outflow mechanism 200 therein, and at least a portion of the injection needle 320 is disposed within the housing 310. The injection needle 320 is pulled out or retracted in the longitudinal direction of the housing 310 through the sliding hole 312 and moves between the first position and the second position. For example, the injection needle 320 may be pulled out from the housing 310 through the sliding hole 312 and placed in the first position. The injection needle 320 may be inserted into the housing 310 through the sliding hole 312 and positioned in the second position. The injection needle 320 is preferably made of a hard material, for example, stainless steel or polypropylene.

The sliding guide portion 322 formed on the outer peripheral surface of the injection needle 320 is disposed within the housing 310 and guides the longitudinal movement of the injection needle 320. For example, the sliding guide part 322 may have an annular structure, and the outer diameter of the sliding guide part 322 may be smaller than or equal to the inner diameter of the housing 310.

The lever 324 is coupled to the sliding guide portion 322. The lever 324 is connected to the injection needle 320 via the sliding guide portion 322. The lever 324 may protrude outward from the sliding guide portion 322 through the slot 314 of the housing 310. The lever 324 is connected to the injection needle 320 and can move along the slot 314 along with the injection needle 320 in the longitudinal direction. The injection needle 320, the sliding guide portion 322, and the lever 324 may be made of the same material as one piece.

The support 342 has an overall bar shape, and the upper end is inserted into the injection needle 320 and the lower end is fixed to the housing 310. The support 342 may be directly fixed to the housing 310, or may be indirectly fixed to the housing 310 by being coupled to the fixing part 350. The support 342 is disposed on the longitudinal axis of the housing 310 and is inserted into the injection needle 320 while being fixed to the housing 310 without being related to the movement of the injection needle 320.

When the injection needle 320 is pulled out through the sliding hole 312 and located in the first position, the waterproof outflow device 200 is disposed within the injection needle 320 and the support 342 is positioned within the injection needle 320. It is supported at the lower part of the waterproof outflow mechanism (200). When the injection needle 320 is inserted through the sliding hole 312 and located in the second position, the waterproof outflow mechanism 200 is naturally exposed to the outside by the movement of the injection needle 320 and the support of the support bar 342. do.

The elastic portion 330 is disposed within the housing 310, preferably between the top of the housing 310 and the lever 324, and more preferably between the top of the housing 310 and the sliding guide portion 322. . The elastic portion 330 provides elastic force to the injection needle 320 so that the injection needle 320 moves from the first position to the second position. The elastic portion 330 may be made of, for example, a spring.

The locking portion 315 is formed in the slot 314 as a means to prevent the longitudinal movement of the lever 324. For example, the catching portion 315 may be formed by extending a gap from the slot 314 in a direction other than the longitudinal direction. When the injection needle 320 is located in the first position, the lever 324 rotates in the longitudinal direction and moves from the slot 314 to the locking portion 315, and the lever 324 and the lever 324 are moved by the elastic portion 330. The longitudinal movement of the injection needle 320 may be prevented.

The buffer unit 340 is disposed within the housing 310, preferably between the bottom of the housing 310 and the lever 324, and more preferably between the bottom of the housing 310 and the sliding guide portion 322. do. When the injection needle 320 moves longitudinally from the first position to the second position by the elastic portion 330, the buffer portion 340 prevents the rapid movement of the injection needle 320 and ensures a smooth and gentle movement. induce. The buffer 340 may be made of, for example, a ring-shaped sponge surrounding the support 342.

The support portion 316 has a structure that protrudes from the side of the housing 310. During a glaucoma treatment procedure, the support portion 316 is seated on the surface of the eye and prevents the shaking of the housing 310 due to the operator's hand tremors when the injection needle 320 enters the housing 310 and moves to the second position, thereby preventing aqueous outflow. Damage to the device 200 can be prevented.

Hereinafter, the operation of the waterproof outflow device insertion device according to the first embodiment of the present invention will be described with reference to FIGS. 1, 4, and 5. Figure 1 is a perspective view showing a case where the injection needle of the waterproof outflow device insertion device according to the first embodiment of the present invention is located in the first position. Figure 4 is a perspective view showing a case where the injection needle of the waterproof outflow device insertion device according to the first embodiment of the present invention is located in the second position. Figure 5 is a cross-sectional view showing an eye into which an aqueous humor outflow device has been inserted by the aqueous humor outflow device insertion device of Figure 1.

Referring to Figures 1 and 5, when the injection needle 320 is pulled out from the housing 310 through the sliding hole 312 and placed in the first position with the waterproof outflow mechanism 200 stored therein. , the operator inserts the injection needle 320 into the sclera 10 of the eye 100 and places it at a specific location. At this time, it is preferable that the movement of the lever 324 and the needle 320 is prevented by the locking portion 315.

Next, referring to Figures 4 and 5, when the operator releases the lever 324 from the locking part 315, the elastic part 330 moves the injection needle 320 from the first position to the second position and the lever 324 ) moves from one end of the slot 314 to the other end. That is, while the injection needle 320 is introduced into the housing 310 through the sliding hole 312, the waterproof outflow mechanism 200 is supported by the support 342, so it is naturally exposed to the outside and is positioned at the specific location. It will remain as is. In this embodiment, the case where the entire injection needle 320 is inserted into the housing 310 at the second position is described as an example, but the present invention is not limited to this. That is, at least a portion of the injection needle 320 may be introduced into the housing 310 so that the waterproof outflow mechanism 200 can be exposed to the outside.

In FIG. 5, reference numeral 20 denotes the cornea, 25 denotes the anterior chamber, 30 denotes the conjunctiva, 40 denotes the lens, 50 denotes the iris, and 60 denotes the aqueous humor.

Hereinafter, a device for inserting a waterproof outflow device according to a second embodiment of the present invention will be described in detail with reference to FIG. 6. Figure 6 is a cross-sectional view cut in the longitudinal direction of the waterproof outflow device insertion device according to the second embodiment of the present invention. For convenience of explanation, members having the same function as each member shown in the drawings (FIGS. 1 to 5) of the first embodiment are denoted by the same symbols and their descriptions are omitted, and the differences will be mainly explained below.

The buffer portion 341 of the waterproof outflow device insertion device 302 according to the second embodiment of the present invention is disposed within the housing 310, preferably between the lower end of the housing 310 and the lever 324. It is disposed between the lower end of the housing 310 and the sliding guide portion 322. The buffer unit 341 prevents the rapid movement of the injection needle 320 and induces a smooth and gentle movement when the injection needle 320 moves longitudinally from the first position to the second position by the elastic unit 330. do. The buffer 341 may be made of, for example, a spring surrounding the support 342.

Although embodiments of the present invention have been described above with reference to the attached drawings, those skilled in the art will understand that the present invention can be implemented in other specific forms without changing the technical idea or essential features. You will be able to understand it. Therefore, the embodiments described above should be understood in all respects as illustrative and not restrictive.

Claims

An aqueous outflow device insertion device for inserting an aqueous outflow device for glaucoma treatment into the eye,

Cylindrical housing;

an injection needle that stores the waterproof outflow mechanism therein and is drawn out or drawn in the longitudinal direction of the housing through a sliding hole formed at the top of the housing and moves between a first position and a second position; and

The lower end is fixed to the housing and the upper end includes a support inserted into the injection needle,

When the injection needle is pulled out through the sliding hole and located in the first position, the support supports a lower portion of the aqueous humor outflow mechanism stored in the injection needle,

When the injection needle is introduced through the sliding hole and moves from the first position to the second position, the aqueous humor outflow mechanism is exposed to the outside by movement of the needle and support of the support. Waterproof outflow device insertion device.
According to paragraph 1,

A slot formed on a side of the housing extends along the longitudinal direction,

A lever connected to the injection needle and protruding to the outside through the slot moves together with the injection needle along the slot.
According to paragraph 2,

An elastic portion disposed within the housing between the top of the housing and the lever provides an elastic force to the needle to move the needle from the first position to the second position,

A waterproof outflow device insertion device, characterized in that a locking portion that prevents movement of the lever when the injection needle is located in the first position is formed in the slot.
According to paragraph 1,

A waterproof outflow device insertion device, characterized in that the buffer disposed between the lower end of the housing and the lever within the housing prevents rapid movement of the needle from the first position to the second position.
According to paragraph 1,

A waterproof outflow device insertion device, characterized in that the fixing part coupled to the bottom of the support is coupled to the bottom of the housing.
According to paragraph 1,

A waterproof outflow device insertion device, characterized in that the support portion protruding from the side of the housing is seated on the surface of the eye to prevent shaking of the housing when the injection needle is inserted.