WO2007052730A1

WO2007052730A1 - Fixture for intravitreous injection

Info

Publication number: WO2007052730A1
Application number: PCT/JP2006/321919
Authority: WO
Inventors: Masafumi Uematsu; Michiko Koga; Takashi Kitaoka
Original assignee: Nagasaki University
Priority date: 2005-10-31
Filing date: 2006-10-26
Publication date: 2007-05-10
Also published as: JPWO2007052730A1; JP5011542B2

Abstract

A novel fixture for intravitreous injection is provided. Namely, a fixture for intravitreous injection comprising: an injection needle fixture plate (4) which has an injection needle insertion hole (6); and an eyeball fixture for fixing the position of the injection needle insertion hole (6) on the eyeball which has a ring (3) having a nonsmooth face to be in contact with the eyeball. Use of this fixture for intravitreous injection makes it possible to avoid the risk accompanying the existing intravitreous injection and the technique therefor is very simple. That is to say, the above-described fixture for intravitreous injection enables highly safe and easy intravitreous injection.

Description

'' Intravitreal injection fixture

Technical field .

The present invention relates to an intravitreal fixing device comprising an eyeball fixing device and an injection needle fixing plate. '

Background art:

Intravitreal injection This is an indispensable therapeutic technique for ophthalmic treatment. This technique is

Gas injection for membrane detachment and macular bleeding, antibiotic injection for blepharitis, and injection of tissue plus mitogenic agent (tPA) (trade name Alteplase) for vitreous hemorrhage. Recently, injection of triamcinoloneacetonide (trade name Kenacort) for inflammatory diseases and macular edema and injection of tPA for macular edema due to retinal bleeding are frequently performed. Although not approved in Japan, injection of anti-VEGF for intravitreal injection (product name: Macugen) for age-related macular degeneration, hyal-mouth nidase formulation for intravitreal injection for vitreous disease (product name: Vitralase) Injections have started. Therefore, the frequency of intravitreal injection is expected to increase in the future, but the procedure of intravitreal injection is relatively difficult. Problems with conventional intravitreal injection techniques include the following. ,

First, there is a risk of retinal damage and lens damage at the time of needle insertion. For the insertion site, it is necessary to measure the 3.5 mm area from the corneal end, which is the injection needle insertion site, but if the position is shifted, the retina, lens or ciliary body may be damaged. There is sex. Regarding the insertion angle, it is necessary to keep the insertion angle of the injection needle at an angle that does not touch the lens and the retina. Furthermore, regarding the penetration depth, it is necessary not to make the penetration depth of the retinal injury injection needle too deep. Depending on the angle, there is a risk of damaging the retina if it is too deep.

In addition, there is a problem that eyeball fixation at the time of injection is unstable. The injection operation requires both a hand to hold the syringe barrel and a hand to push the syringe down. For this reason, at the time of injection, the eyeball must be fixed at one point only at the insertion point. Become. There is also a method in which the eyeball is fixed with one hand and the other hand can be used for injection, but there is a risk of damage as described above due to the tendency to shake. ■ · '■ ■ ■''

Furthermore, there is a problem of anterior aqueous humor removal. In order to avoid an increase in intraocular pressure, it is necessary to remove the anterior aqueous humor. In this work, a thin knife is inserted into the anterior chamber from the end of the cornea and an appropriate amount of anterior aqueous humor is drained out of the eye. When removing the aqueous humor after intravitreal injection, the intraocular pressure temporarily becomes high. On the other hand, when removing the aqueous humor before intravitreal injection, the eyeball is distorted during intravitreal injection, making injection difficult. References to conventional procedures for intravitreal injection include, for example, Kazunori Kamio and Shin Tamai: Intraocular injection. Ophthalmology 1005-1004, 2002, etc. .. Disclosure of the invention

Therefore, it is an object of the present invention to develop a fixing device for intravitreal injection that can be used for the purpose of safely and easily performing intravitreal injection without such danger and inconvenience. .

Therefore, the present inventors have developed an intravitreal injection fixture characterized by including an injection needle fixing plate in addition to the conventional eyeball fixator. By using this fixture, it is possible to eliminate the problems of conventional procedures. That is, the present invention comprises an injection needle fixing plate having an injection needle insertion hole, and an eyeball fixing device having a non-smooth eyeball contact surface and a ring for fixing the position of the injection needle insertion hole on the eyeball. An intravitreal injection fixture is provided. The present invention provides a novel intravitreal injection fixture. A glass of the present invention comprising: an injection needle fixing plate having an injection needle insertion hole; and an eyeball fixing device for fixing the position of the injection needle insertion hole on the eyeball, comprising a ring having a non-smooth eyeball contact surface By using the in-vivo injection fixture, the risk of conventional intravitreal injection can be avoided and the procedure is very simple. Accordingly, the intravitreal injection can be performed safely and easily by the intravitreal injection fixture of the present invention.

Brief Description of Drawings FIG. 1 is a side view of the fixing device for intravitreal injection according to the present invention. FIG. 2 is a top view of the intravitreal injection fixture of the present invention.

Fig. 3 is an enlarged side view of the ring and the needle needle plate

FIG. 4 is an enlarged side view with the injection needle inserted.

FIG. 5 is a schematic view of the state where the intravitreal injection fixture of the present invention is applied to the eyeball as seen from above.

FIG. 6 is a schematic view of a state in which the injection needle is inserted by applying the intravitreal injection fixture of the present invention to a ball.

Fig. 7 is a photograph showing the fixation of the eyeball for intravitreal injection.

Fig. 8 is a photograph showing how the insertion part is measured. Fig. 9 is a photograph showing a state where the injection needle is inserted.

FIG. 10 is a photograph showing how the aqueous humor is removed.

Figure 11 is a photograph showing the injection into the vitreous.

Figure 12 is a photograph showing how the aqueous humor is removed.

BEST MODE FOR CARRYING OUT THE INVENTION

A novel intravitreal injection fixture of the present invention includes an injection needle fixing plate having an injection needle insertion hole, and a ring having a non-smooth eyeball contact surface, and fixes the position of the injection needle insertion hole on the eyeball. It is composed of an intravitreal injection fixture consisting of: The intravitreal injection fixture of the present invention is obtained by integrally forming an injection needle fixing plate on a conventional eyeball fixator and can easily and accurately perform intravitreal injection. Therefore, by using the intravitreal injection fixture of the present invention, the risk of medical errors associated with intravitreal injection can be greatly reduced.

A view of the intravitreal injection fixture of the present invention viewed from the side is shown in FIG. For the convenience of handling, in the eyeball fixator 2 of the intravitreal injection fixture 1, the ring 3 is obliquely connected to the holding part of the eyeball fixator 2 so as to have a certain angle, and further injected. Fixing plate 4 is attached. Further, FIG. 2 shows a top view of the intravitreal injection fixture of the present invention. In Figure 2:. As shown, for injection fixing plate to the ring 3 of the eye fixed 2 ⁴ are attached, the ring 3 has an opening 5, further injectable fixing plate 4 Note Ihari insertion hole 6 Have. -'''Fig. 3 is an enlarged side view of the ring and needle fixing plate. The injection fixing plate 4 has a needle insertion hole 6, and the ring 3 has a spike-like projection 7 ′ that is not smooth. Fig. 4 is an enlarged side view with the injection needle inserted. The injection needle 8 is inserted into the injection needle insertion hole 6.

Further, FIG. 5 shows a schematic view of the state in which the intravitreal injection fixture of the present invention is applied to the eyeball as seen from above. The ring 3 of the intravitreal injection fixture 1 is placed on the cornea 10 of the eyeball 9, and the injection fixing plate 4 attached to the ring 3 has a needle insertion hole 6. : 'Furthermore, Fig. 6 shows a schematic view of the state in which the injection needle is inserted by applying the intravitreal injection fixture of the present invention to the eyeball. The injection needle 8 is inserted into the vitreous body 11 of the eyeball 9 through the injection needle insertion hole 6. Since the position and angle of the injection needle insertion hole 6 are appropriate, the injection needle 8 does not damage the lens 12 or the like.

The eyeball fixing device 2 and the injection needle fixing plate 4 are not necessarily formed integrally, and it is also preferable in the present invention that the eyeball fixing device 2 is connected to the injection needle fixing plate 4 via an adapter ”. According to the intravitreal injection fixture of the present invention, the intravitreal fluid can be extracted by inserting the injection needle into the vitreous and then performing an anterior chamber puncture. Since the intraocular pressure is not increased since the intraocular pressure is not extracted, the ocular fixation ring of the present invention has an opening for anterior chamber puncture. Having 5 is a preferred embodiment.

Further, the diameter of the ring 3 of the eyeball fixator 2 is preferably 10 mm or more and 16 mm or less, and more preferably 13 mm. The diameter of the ring 3 is not particularly limited, but can be adjusted as appropriate according to the size of the cornea of the specimen undergoing the intravitreal injection procedure. Eye fixing device: If the contact surface of the ring 3 of the ring 3 is a flat ellipse, it will be inconvenient because it will slip even if it tries to fix the ring to the eyeball. In the present invention, the shape of the eyeball: contact surface of the ring of the eyeball fixator is not particularly limited as long as it is not smooth. In the present invention, it is a preferred aspect that the eyeball contact surface of the ring of the eyeball fixture has spike-like protrusions or unevenness of a snow tire pad.

For intravitreal injection, the optimal injection site is generally 3.5 mm from the edge of the cornea. If this position is shifted, the retina, lens or ciliary body may be damaged, so the injection site must be set accurately. Since the ring 3 of the eyeball fixation device 2 is sized so as to almost cover the cornea, by installing the needle insertion hole 6 so that the injection needle can be inserted at a position about 3.5 mra from the ring 3 It is not necessary to measure at the time of insertion of the injection needle, and intravitreal injection can be performed safely.

Therefore, as shown in FIG. 3, the distance between the injection needle insertion hole 6 and the ring 3 (distance between the insertion hole and the ring 1 3) is a force of 3.0 thigh or more and 5.0 mm or less. However, the present invention is not limited to this. In this specification, the distance 13 between the insertion hole and the ring means the distance between the center portion of the injection needle insertion hole 6 and the end on the side where the ring 3 is connected to the injection needle fixing plate 4. To do. The distance 13 between the insertion hole and the ring is 3.5 mm, which is the most preferable aspect in the present invention.

Furthermore, it is necessary to keep the insertion angle of the injection needle at an angle that does not touch the crystalline lens and the retina. By setting the insertion angle of the injection needle appropriately, it can be fixed at a safe 'angle optimum for intravitreal injection. Specifically, the angle between the plane (ring plane 14) and the needle insertion hole 6 (ring angle 15 between the plane and the injection needle) formed by the ring 3 of the eyeball fixator 2 that fixes the eyeball is 50 degrees. The above 70 degrees or less is a preferred embodiment in the present invention, but is not limited thereto. The angle between the plane (ring plane 14) formed by the ring of the eyeball fixator and the injection needle insertion hole (angle 15 between the plane and injection needle) is 60 degrees. It is. In the present invention, the insertion depth of the injection needle is also important. It is necessary not to squeeze the needle into the needle too deeply, and depending on the piercing angle, it will damage the mesh. If the length of the needle insertion hole is 3, a 27-gauge needle with a length of 19 mra will be about 15 mm to enter the vitreous, and will not be deep enough to penetrate the retina. Considering this, the length 16 of the injection needle insertion hole in the eyeball fixing device is l. Omra or more and 6. Omm or less, which is a preferred embodiment in the present invention, but is not limited thereto. is not. The length 16 of the needle insertion hole in the eyeball fixing device is 5.0, which is the most preferable aspect in the present invention.

As described above, the first advantage of the intravitreal injection rod fixing device is that the risk of conventional intravitreal injection can be avoided. The second advantage is that the stability of eyeball fixation at the time of injection is good. Therefore, once the needle is inserted, the needle is fixed in the optimal position even if you take your hand off. In addition, the syringe can be moved and injected easily with one hand. A third advantage is that the anterior aqueous humor can be removed while the injection needle is fixed. After inserting the injection needle, the anterior aqueous humor can be removed by releasing the hand once. As a result, high intraocular pressure after intravitreal injection can be prevented. In addition, it is possible to remove the anterior aqueous humor from the intravitreal injection fistula in advance using conventional techniques. However, in this case, the eyeball is not stretched, and the eyeball is distorted during intravitreal injection, making it difficult to insert. However, the intravitreal injection fixture of the present invention does not have such a disadvantage. A fourth advantage is that intravitreal injection using the device of the present invention is a very simple procedure. Because there are fewer procedures and higher safety compared to conventional methods, intravitreal injection can be performed more easily than in the past.

Example

EXAMPLES The present invention will be specifically described below with reference to examples, but the present invention is not limited to these examples. In this example, the procedure of intravitreal injection by the conventional method was compared with the case of using the vitreous injection fixture of the present invention using the extracted porcine eyeball. (Eyeball fixation)

First, the eyeball is fixed for intravitreal injection. Figure 7 shows the insulator. FIG. 7A shows a state in which the eyeball is fixed by a conventional procedure, and FIG. 7B shows a state in which the eyeball is fixed by a procedure using the vitreous injection fixing tool of the present invention. Although there is no problem with eyeball fixation with the conventional method of the eye, the fixture is more stable because it can fix more than 3/4 around the cornea. In Fig. 7, the left and right injection needles of the eyeball are for fixing the eyeball and are not related to the procedure. In addition, because the corneal eyeball is larger than the human eye, the fixation ring is on the cornea.

(Measurement of insertion part)

Next, the insertion portion is measured. This is shown in Fig. 8. Fig. 8 shows the state of measuring the measurement insertion part located 3.5 mm from the end of the cornea using a conventional procedure. On the other hand, when the vitreous injection fixture according to the present invention is used, the injection needle fixing plate has the injection needle insertion hole, so there is no need to measure the insertion portion.

(Injection of needle)

Next, the needle is inserted. This is shown in Fig. 9. FIG. 9A shows a state where the needle is inserted by a conventional technique, and FIG. 9B shows a state where the needle is inserted by a technique using the vitreous injection fixture of the present invention. In conventional procedures, it is necessary to pay close attention to the injection site of the injection needle, the insertion angle, and the insertion depth, and the insertion of the injection needle is unstable. It is necessary to hold carefully so as not to shake. On the other hand, in the technique using the vitreous injection fixing tool of the present invention, the optimal insertion site, insertion angle, and insertion are performed by inserting the injection needle into the injection needle insertion hole of the injection fixing plate. Depth of penetration can be obtained. In addition, since the syringe is fixed, there is an advantage that there is no problem even if the hand is released after insertion.

(Removal of anterior aqueous humor)

In addition, it is difficult to remove the aqueous humor before the injection into the vitreous after inserting the injection needle with the conventional technique. On the other hand, when the vitreous injection fixture of the present invention is used, it is injected at this stage, that is, after the injection needle is inserted, into the vitreous body. The anterior aqueous humor can be removed before As a result, temporary high intraocular pressure associated with intravitreal injection can be avoided. The anterior aqueous humor is removed using the vitreous injection fixture of the present invention. It is possible to remove the aqueous humor from the opening of the ring of the fixation plate for injection, and the syringe is fixed even if the hand is released.

(Intravitreal injection)

Next, injection into the vitreous is performed. This is shown in Figure 11. Figure 1 1

A shows the injection into the vitreous using a conventional procedure, and Fig. 11B shows the injection into the vitreous using a procedure using the vitreous injection fixture of the present invention. With conventional technology, careful attention must be paid to the insertion angle and depth. In addition, holding the syringe with one hand and fixing the eyeball with only one point of insertion to push down the syringe with the other hand is very unstable. On the other hand, in the procedure using the vitreous injection fixture of the present invention, the fixation is very good, and the injection is completed only by depressing the syringe.

(Removal of anterior aqueous humor)

Figure 12 shows how the aqueous humor is removed using conventional technology. In the conventional technique, it is necessary to remove the anterior aqueous humor after the injection into the vitreous, so that the intraocular pressure continues until the anterior aqueous humor is removed. If the anterior aqueous humor is removed prior to the injection of vitreous fistula in the prior art, there is a problem that the eyeball is not stretched and the eyeball is distorted during intravitreal injection, which makes it difficult to insert. .

Industrial applicability ·

According to the present invention, a novel intravitreal injection fixture is provided. By using the intravitreal injection fixture of the present invention, the risk of conventional intravitreal injection can be avoided and the procedure is very simple. Therefore, the intravitreal injection fixture of the present invention is very useful as a medical instrument in the ophthalmic field.

Claims

:, . The scope of the claims : .

1. An intravitreal injection comprising an injection needle fixing plate having an injection needle insertion hole and a ring having a non-smooth eyeball contact surface, and an eyeball fixing device for fixing the position of the injection needle insertion hole on the eyeball. Fixture.

2. The intravitreal injection according to claim 1, wherein the eyeball fixing device and the injection needle fixing plate are integrally formed, or the eyeball fixing device is connected to the injection needle fixing plate through an adapter. Fixture. .

3. The intravitreal injection fixture according to claim 1, wherein the ring has a diameter of 10 mm or more and 16 mra or less.

4. The intravitreal injection fixture according to any one of claims 1 to 3, wherein the ring has an opening for anterior chamber puncture.

5. The intravitreal injection fixture according to any one of claims 1 to 4, wherein the eye contact surface of the ring has a spike-like projection. .

6. The intravitreal injection fixture according to any one of claims 1 to 4, wherein the eye contact surface of the ring has a snow tire pattern unevenness.

7. The glass according to any one of claims 1 to 6, wherein a distance between the injection needle insertion hole and the ring of the eyeball fixation device is not less than .3.0 mm and not more than 5. Oram. Fixture for internal injection.

8. The intravitreal body according to any one of claims 1 to 7, wherein an angle formed by a plane formed by the ring of the eyeball fixator and the injection needle insertion hole is not less than 50 degrees and not more than 70 degrees. Injection fixture.

9. The intravitreal injection fixture according to any one of claims 1 to 8, wherein the length of the injection needle insertion hole in the eyeball fixator is 1. Oram or more and 6. Oram or less.