JPH09276318A - Insertion tool for pipe in lacrimal duct - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a lacrimal duct insertion tool which is stable inside a lacrimal duct and easy to be inserted into a lacrimal duct without causing lacerations at a lacrimal point or in a small lacrimal duct, to be used as a lacrimal point plug for lacrimal duct reconstruction, or to be used as a drug delivery system for treatment of glaucoma, uveitis, conjunctivitis, or keratitis, etc. SOLUTION: This tool consists of two end members 51, one center member 50 located between the two end members 51, and two connecting members 71 to connect the end members 51 and the center member 50, and also has two notches 55 for a probe to be inserted. The end members 51 are made of pipes, and the tops of them are blind ends 53. The connecting members 71 are more flexible than the end members 51 and the center member 50, and the outer diameter of the connecting member 71 is smaller than that of the end member 51 or the center member 50. By infiltrating medicine into the center member 50 or the end members 51, or installing a medicine injection device 25 at the center of the center member 50, the tool can be used as a drug delivery system.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a lacrimal canal intubation device for treating lacrimal canal obstruction, lacrimal inflammation, conjunctivitis, keratitis, uveitis, dry eye and glaucoma.

[0002]

2. Description of the Related Art As shown in FIG. 1, tears are secreted from a lacrimal gland 19 and discharged through the lacrimal passage into the inferior nasal passage. The lacrimal passage
Upper puncta 11, lower puncta 12, upper canaliculus 13, lower canaliculus 1
4. The lacrimal canaliculus 15, the lacrimal sac 16, and the nasolacrimal duct 17 are formed. The lower end of the nasolacrimal duct 17 is open to the inferior nasal passage. The problem with eye drops such as pilocarpine used in the treatment of glaucoma is that they are immediately excreted through the lacrimal tract. Also, the lower punctum 12 is pressed with a finger.

[0003] Drugs such as pilocarpine instilled are first mixed with tears. At this point, the drug solution that has exceeded the space between the cornea and the eyelids flows out of the eye with tears. Some of the excess drug solution flows through the lacrimal passage toward the nasal cavity.

[0004] The drug remaining in the eye is diluted with tears, and the drug disappears exponentially, and its half-life is reported to be 3 to 8 minutes. For example, Mishima et a
l: Determination of tear v
olume and tear flow. Inve
st Ophthalmol 5: 264, 1966.
See Further, the instilled drug flows through the cornea into the aqueous humor in the space between the cornea and the lens, but in a very small amount. Glaucoma is caused by a chronic inflow / outflow abnormality of the aqueous humor that occupies the cornea and lens. Therefore, it is desirable that the therapeutic agent passes through the cornea and continuously flows into the aqueous humor. For example, Takeo Kawaguchi, et al., "Dosage Forms for Ocular Mucosa and Its Mechanism," Pharmacy 39: 1287, 1988. See

[0005] Ophthalmic administration is by no means an ideal drug administration method. In particular, the instilled drug migrates into the eye,
For the purpose of achieving the intended therapeutic effect, only a few percent of the instilled drug migrates into the eye, and the concentration of the drug that migrates into the eye is 15-60. After reaching a maximum after minutes, it decreases exponentially with time. Effector si
When the drug concentration in te) drops below a certain level, the therapeutic effect of the drug is lost. The amount of drug instilled into the eye is
Generally dependent on dosage. In order to sustain the therapeutic effect of a drug administered by eye drops to a certain extent, it is necessary to overdosage a large amount far exceeding the minimum required for obtaining the effect. In addition, in order for the intraocular drug concentration to exert a therapeutic effect, it is necessary to administer a large amount of drug again (underdosing) again at an insufficiently reduced level (underdosing). It is. Ophthalmic therapy is not only uneconomical because it administers drugs far beyond the required dose, but also has a high risk of developing local and systemic side effects of the drug, and underdosing. The period of (1) has drawbacks in that a sufficient therapeutic effect cannot be obtained, and since the patient performs eye drops, heavily depends on the patient's voluntary cooperation (compliance). For example, Katsuaki Kitazawa, "Effects and Usage of Ocusert" Ophthalmology 2
6: 925-928, 1984. See

[0006] For example, pilocarpine hydrochloride eye drops have been used as anti-glaucoma drugs for a long time because they have an intraocular pressure-lowering effect. In this method, the amplitude of the pilocarpine concentration in the anterior chamber of the eye is extremely large. This is necessary for overdose in order to have a certain duration of effect.
ng) is unavoidable. High dose (ove
(rdosing) enhances the intraocular pressure-lowering effect of pilocarpine, but also enhances side effects. Side effects of pilocarpine include myopia and darkness due to miosis. Myopia is caused by contraction of the ciliary muscles, making it difficult to see far away. Eyeglass correction may be necessary for young people. Also,
Patients complained of darkness due to miosis,
Driving a car at night becomes difficult. Cataract patients are particularly apt to have poor vision. Further, what is instilled is excreted into the nasal cavity through the lacrimal passage and absorbed through the mucous membrane, which causes systemic side effects such as sweating, increased salivary secretion, vomiting and diarrhea. For example, Makoto Shinke, "Oxate Ophthalmic Treatment System", Japan Clinical 47: 1357-1362.
1989. See

[0007] As described above, in order to maintain the therapeutic effect, frequent instillation of an effective amount or more is necessary, and it has been difficult to maintain a continuous desirable intraocular pressure. Ocusert 25 shown in FIG. 2 was considered to reduce the side effects of pilocarpine. Ocusert 25 is a drug administration system developed by ALZA of the United States, which has been in the United States since 1974 and in Japan since 198.
It has been on the market for one year (from Fujisawa Pharmaceutical). As shown in FIG. 2, the occupate 25 includes an elliptical polymer film 21, a white support 24 at the periphery, and a drug reservoir 22. The polymer film 21 and the white support 24 are made of an ethylene vinyl acetate copolymer. The drug reservoir 22 is a pilocarpine core 22, which is a formulation surrounding pilocarpine hydrochloride and alginic acid. The polymer film 21 functions as a drug release control film 21 and can be inserted into the conjunctiva only once.
It releases pilocarpine in tears little by little over the weeks. Ethylene vinyl acetate copolymer is chemically similar to polyethylene, constitutes a transparent flexible membrane, and has selective permeability to substances. Titanium oxide (Ti
O ₂ ) is a white pigment impregnated in the support 24.
The aforementioned alginic acid is a viscous substance separated from seaweed and used as a carrier for pilocarpine. Ocusert 2
5 has two types, P-20 and P-40. Ocusert P-20 is present in tears at a rate of 20 per hour for one week.
At a rate of μm, P-40 releases pilocarpine hydrochloride at a rate of 40 μm per hour. Ocusert P-40
2 mg of di (2-ethylhexyl) phthalate (2) is added to the film in order to enhance the release of pilocarpine from the ethylene vinyl acetate copolymer film 21.
For example, Tokuharu Suzuki, "New Drugs Due to Advances in Preparation," Internal Medicine 49: 696-701, 1982. reference.

[0008] Ocusert 25 is compared with conventional eye drops.
Since the insertion only needs to be performed once a week, the trouble of instilling several times a day can be avoided. According to this, it is possible to control the intraocular pressure at bedtime. Unlike ophthalmic solutions that cannot maintain a constant amount of intraocular drug, Ocusert 25 maintains a constant amount of effective drug and shows a stable intraocular pressure regulating effect. Thereby,
Side effects such as miosis can be avoided by administration of pilocarpine hydrochloride. The total dose of the drug is much lower than that of eye drops. Although it has such advantages, however, occultate has not been widely used due to the following problems, and has been hardly used in Japan since March 1994.

Dry eye is a disease caused by a small amount of tears secreted from the lacrimal gland 19. In order to prevent tears from draining into the lacrimal canal, the upper punctum 11 and the lower punctum 12 are removed. Cauterization and plugging or plugging with punctal plugs are used. The method of placing a silicone tube in the lacrimal canal is an effective treatment for treating lacrimal canal obstruction. However, in the conventional silicone tube indwelling method represented by the Crawford method, the insertion method is difficult, and the indwelled silicone tube does not have sufficient stability, so that it is not widely used. Conventional silicone tubes have insufficient flexibility at the center of the tube.
Therefore, even when the central portion was lifted with tweezers, it was not strongly bent in an inverted U-shape. The elasticity of the central portion of the tube contributed to instability in the lacrimal canal. In the Crawford method, the tip of the tube was tied in the nasal cavity, a knot larger than the size of the opening at the lower end of the nasolacrimal duct was formed, and the tube was left as it was. However, it is difficult to confirm the size of the opening at the lower end of the nasolacrimal duct. When the knot is smaller than the opening at the lower end of the nasolacrimal duct, there is also a problem that the knot moves upward and enters the lacrimal sac. Because of the very small diameter of the lacrimal canaliculus, it was very difficult to remove the knot once it had entered the lacrimal sac.

Therefore, the present inventor has proposed that the total length be 80 to 130.
mm, and a 20 to 40 mm central portion is thin and flexible. This tube is thin and flexible at the center and thick and hard at both ends. When the center is lifted, the tube is easily bent into an inverted U shape by gravity. Therefore, this tube is much more stable than the conventional silicone tube, and it is very rare that the tube comes out. In addition, since this tube has blind ends at both ends and has a cut for inserting the probe, it can be easily inserted into the lacrimal canal. It also has the advantage that removal can be easily performed. The present inventor has applied this tube to more than 100 cases of lacrimal canal obstruction, but it has been confirmed that the tube has good stability in the lacrimal canal and escapes rarely. In addition, this tube has been confirmed to be useful for blocking and narrowing the lacrimal canal as a treatment for dry eye and glaucoma. In addition, in the conventional punctal plug, the stability is poor, so that it often slips out, and the stimulation of the tip of the punctal plug often causes lacrimal canaliculus obstruction.
When this tube is used in place of a punctal plug, it rarely escapes or causes lacrimal canaliculation.

[0011]

However, generally, both ends of the tube are pulled toward the nasal cavity by the action of the lacrimal passage. For this reason, as shown in FIG. 3, the thin and flexible portion 40 at the center of the tube cuts into the punctum or lacrimal canaliculus,
Tears 41 were sometimes formed in the punctum or lacrimal canaliculus. The tear is more likely to occur as the center of the tube that touches the punctum becomes thinner and harder. Even if the tube central portion is relatively thick, if the material is too soft, the tube central portion is pulled and becomes thin and hard, so that the tear 41 is likely to occur. If the material forming the center of the tube is too soft,
When the center is picked up with tweezers and lifted, the tube becomes a strong inverted U-shape, but the use of such a tube tends to cause tear 41. Further, as shown in FIG. 4, it is not uncommon for the wall 42 at the distal end of the tube to be pierced by the distal end 93 of the probe 91 when the tube is inserted, and this is due to the hardness of the material forming the wall of the tube. This is more likely to occur as the thickness of the sample becomes smaller and the thickness of the sample becomes smaller.
In addition, placing a tube in the lacrimal passage makes infection more likely.

The occupate 25 shown in FIG. 2 is used by putting it in the eye like a contact lens.
The patient complains of foreign body sensation, hyperemia, lacrimation, eye oil, and eye pain due to irritation of the ocular surface due to 5, difficulty in handling when inserting and removing the occupate 25, and frequent dropout of the occultate 25 Since it may be lost or the patient may be unaware of the dropout of the occultate 25, it may remain unmedicated, or may have dropped out even though the occupate 25 has not dropped out. The problem is that it can happen. For example, Akira Nakajima “aging ophthalmic preparation” Clinical and Pharmacological Treatment 8: 516
-519, 1989. See The above occultate 25
The problems described above are based on the fact that the occupate 25 is not fixed on the surface of the eye and easily moves like a contact lens.

In view of the above-mentioned problems of the prior art, the present invention has good stability in the lacrimal canal, is easy to insert into the lacrimal canal, and causes tears and infections in the lacrimal punctum and lacrimal canaliculus after placement. The aim is to be afraid and not to break the tube with the son.

[0014] Another object of the present invention is to provide an endotracheal intubation device which can also be used as a drag delivery system for treating lacrimal canal obstruction, lacrimal inflammation, dry eye and glaucoma.

[0015]

SUMMARY OF THE INVENTION The present invention is directed to at least one of the two objects set forth above.
The gist is the lacrimal canal intubation device according to any one of the above.

For example, the device of the present invention has a bilaterally symmetric shape.
It is composed of one end member 51, one center member 50 arranged between the two end members 51, and two connecting members 71 connecting each of the two end members 51 to the center member 50. Each end member 51 has two cuts 55 for inserting the probe 91. The end member 51 is formed of a pipe material, and its end is a blind end 53.
The connecting member 71 is more flexible than the end member 51 and the center member,
The outer diameter of the connecting member 71 is smaller than the outer diameters of the end member 51 and the center member 50. Then, the drug release device 25 is attached to the central member 50, or the central member 50 or the end member 51 is attached.
It can be used not only as a stent for treatment of lacrimal canal obstruction but also as a drag delivery system, and can be used in place of a punctal plug for treatment of dry eye.

[0017]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the lacrimal canal intubation device of the present invention will be described below with reference to the drawings.

FIGS. 5, 6 and 7 show a lacrimal canal intubation device (hereinafter simply referred to as an intubation device) according to the present invention. FIGS. 5 and 6 are sectional views, and FIG. FIG. The intubation device comprises two end members 51 and 2 arranged on both sides.
One central member 50 and one end member 51 between the two end members
And the two connecting members 71 connecting the central member 50 and the center member 50. The center member 50 and the connecting member 71 are made of silicone rubber. In this embodiment, the end member 51 is also made of silicone rubber. The end 53 (1 mm) of the end member 51 is a blind end. A small notch 5 for inserting the probe 91 is formed in the end portion near the center of the end member 51.
5 are formed. The cut 55 is formed parallel to the axial direction. The probe 91 is inserted from the slit 55 to the blind end, and the intubation instrument is placed in the lacrimal canal using the probe 91. In this embodiment, the outer diameter of the connecting member 71 is supple and smaller than the outer diameters of the end member 51 and the center member 50. The connecting member 71 has a solid rod shape as shown in FIG. 5 or a pipe shape as shown in FIG. I have. Now, as a material for the intubation device, flexibility and strength are required. In terms of strength, it is necessary to have a strength that can withstand the pulling force applied during the placement operation in the lacrimal canal, the pulling force acting after placement, the pulling force at the time of removal, and the like. On the other hand, in terms of flexibility, it is necessary to be flexible enough to perform the placement operation smoothly and to obtain stability in the lacrimal passage after placement. In addition to the conditions of such tensile strength and flexibility, it is also important to be harmless to the human body. From such a point of view, the strength such as tensile strength tends to increase as a material suitable for the intubation device. The flexibility of the connecting member 71, the end member 51, and the center member 50 can be evaluated based on, for example, Shore hardness defined by JIS. Shore hardness is measured with a durometer (Durometer), and the unit is Shore A (JIS). The higher the Shore hardness value, the harder the hardness.

The connecting member 71, the end member 51, and the center member 50
The hardness (flexibility) is described. The connecting member 71 has a Shore hardness of 20 to 80 (shore A (JIS)).
, Preferably 40-80 (store A),
Optimally, it can be set in a range of 50 to 60 (short A). The Shore hardness of the end member 51 is 60 to 80 (shor).
e A), preferably 70-80 (short)
A), optimally, it can be set in the range of 75 to 80 (store A). When used for lacrimal reconstruction, the center member 50 has a Shore hardness of 20 to 80 (Shore A), but desirably ranges from 50 to 80 (Shore A), and optimally ranges from 60 to 75 (Shore A). Can be set to On the other hand, when the center member 50 contains a drug and is used as a drag delivery system for treating glaucoma, the center member 50 is preferably soft, and thus has a Shore hardness of 20 to 50.
(Short A), preferably 30 to 50
(Shore A), optimally 35-40 (Shore A)
It can be set in the range of A).

Next, the length of the intubation instrument and each member will be described. The overall length of the intubation device is generally 50-130 mm, but is preferably 90-120 mm, optimally 95-1 mm.
It can be set to a range of 10 mm. The length of the end member 51 is 10 to 60 mm, but preferably 30 to 45 m.
m, optimally in the range of 33 to 40 mm. In addition, the length of the central member 50 is 15 to 35 mm, but can be preferably set to a range of 20 to 30 mm, and optimally to a range of 23 to 28 mm. The length of the connecting member 71 is 2 to 10 mm, but the outer diameter of the connecting member 71 is the same as the inner diameter (b) of the end member 51 or the central member 50 as shown in FIG. Each of the two ends 60 is connected to the end member 51 or the center member 50.
And glue it with silicone glue. The length of the bonding portions 61, 62 (h, f) of the connecting member 51 is 1 to 10 mm,
It is preferably 1 to 5 mm, and most preferably 1 to 3 mm. In this case, the length of the portion (g) appearing on the outer surface of the connecting member 71 is 0.5 to 3 mm, but preferably 0.5 to 3 mm.
It can be set to 1.5 mm, optimally in the range of 0.7 to 1.0 mm.

Next, the outer diameter, inner diameter, and wall thickness of each member will be described. The outer diameter (s), inner diameter (t), and wall thickness (c, y) of the end member 50 are 0.6 to 1.2 mm and 0.3 to 0.
6 mm and 0.2 to 0.5 mm, preferably 0.9 to 1.1 mm, 0.4 to 0.5 mm and 0.2, respectively.
5 to 0.4 mm, optimally 0.95 to 1.0 mm each,
It can be set in the range of 0.4 to 0.48 mm and 0.25 to 0.3 mm. On the other hand, the outer diameter (s), inner diameter (t), and thickness (u) of the central member 50 are 0.6 to 1.5 mm, 0.3 to
0.6 mm and 0.2 to 0.8 mm, preferably 0.9 to 1.3 mm, 0.4 to 0.5 mm, and 0.
25-0.5mm, optimally 0.95-1.0m each
m, 0.4 to 0.48 mm, and 0.25 to 0.3 mm. The outer diameter of the connecting member 71 is the end member 51.
And the same as the inner diameter (b, t) of the central member 50, and 0.3 to
0.6 mm, preferably 0.4-0.5 mm,
Optimally, it can be set in the range of 0.4 to 0.45 mm.

The length (e) of the tip of the blind end 53 shown in FIG.
Is 0.2 to 2 mm, preferably 0.3 to 1.5 mm, and most preferably 0.4 to 0.7 mm. Further, the length (d) of the lumen of the blind end portion 53 is 0.2 to 1.5 mm, preferably 0.1 to 1.5 mm.
It can be set in the range of 3 to 1.0 mm, optimally 0.4 to 0.7 mm.

FIG. 8 has the same outer shape as FIGS. 5 and 6, except that the central member 50, the end member 51, and the connecting member 71 have an integral structure without an adhesive portion.

The embodiment shown in FIG.
1. The connecting member 71 has an integral structure, and the central member 5
0 is not a pipe but a solid rod.

FIG. 10 is a schematic diagram showing a state when the embodiment shown in FIGS. 5, 6, 7, 8 and 9 is carried out.
As shown in FIG. 10, the probe 91 is inserted from a small cut 55 provided in the end member 51 to the terminal end 53 of the blind end member. The terminal end 53 of the end member is inserted from the puncta 12 through the lacrimal canaliculus 15, the lacrimal sac 16, and the nasolacrimal duct 17 to the inferior nasal passage.

FIG. 11 is a conceptual diagram showing the indwelling state in the lacrimal canal of the embodiment shown in FIGS. 5, 6, 7, 8, 9 and 10.

The manufacturing method of the embodiment shown in FIG. 5 will be described. First, the center member 50, the end member 51, and the connecting member 71 having the above-described dimensions and hardness are prepared. Both ends 60 of the connecting member 71 are inserted into the open end 61 of the end member 51 and the end 62 of the central member, and are bonded with silicone glue. Both ends 6 of central member 50
2 and the open end 61 of the end member 53 are shaved so as to smoothly transition to the connecting portion 71 to eliminate a step. next,
0.3-0.0.0 along the axial direction near the open end of the end member.
A cut 55 of 7 mm is formed. Further, a center mark 59 is provided at the center of the intubation instrument for convenient centering. With the center mark 59, it can be confirmed whether the intubation instrument has been correctly inserted into the lacrimal canal. As shown in FIG. 9, the indwelling may be performed so that the center mark 59 is located between the upper and lower punctum. The mark 57 is also provided at a position 10 mm from the blind end 53.
Is provided. The mark 57 is used as a guide when the intubation device is inserted, and it is convenient to provide the mark 57 in accordance with the length of the canaliculus, which is approximately 10 mm.

In the embodiment shown in FIG. 12, the blind end 53 has a glans-like thickness, and the maximum diameter (m) of the glans is 1.05.
~ 1.25 mm, desirably 1.05-1.2 mm,
Optimally, it can be set in the range of 1.08 to 1.12 mm.
The thickness (n) of the glans 53 is 0.2 to 0.5 mm, preferably 0.25 to 0.45 mm, and most preferably 0.2 to 0.5 mm.
3 to 0.4 mm. The length (e) of the tip of the glans 53 is 0.2 to 1.5 mm.
It is 3 to 1.0 mm, optimally 0.4 to 0.6 mm.
The central length (d) of the glans 53 is 0.2 to 1.5 m
m, preferably 0.3-1.0 mm, optimally 0.4-
It is 0.7 mm. The length (q) of the other end of the glans 53 is 0.2 to 20 mm, preferably 0.3 to 5 m.
m, optimally between 0.5 and 3 mm.

FIG. 13 is a conceptual view showing still another embodiment in which the same outer shape as that of the embodiment of FIG. 12 is inserted into the lacrimal canal. ing.

FIG. 14 shows still another embodiment.
Although the outer diameter of the central member 50 is smaller than the outer diameter of the end member 51 and is formed of a pipe material larger than the outer diameter of the connecting member 71, the end member 51 and the connecting member 71 are the same as in the embodiment shown in FIG. The outer diameter, inner diameter, and thickness of the central member 50 can be set to 0.4 to 1.0 mm, 0.3 to 0.6 mm, respectively.
0.1 to 0.35 mm, but preferably each is 0.1 to 0.35 mm.
5 to 0.9 mm, 0.4 to 0.5 mm, 0.15 to 0.
25 mm, optimally 0.6-0.8 mm, respectively.
4-0. . 48 mm, can be set in the range of 0.18 to 0.23 mm, but for the flexibility of the central member 50,
The range can be set in the same range as the embodiment shown in FIG.

FIG. 15 is a cross-sectional view of still another embodiment, which shows the same outer shape as the embodiment shown in FIG.
Are made of solid rods instead of pipe material.

FIG. 16 is a perspective view showing the outer shape of the embodiment shown in FIGS.

FIG. 17 is a sectional view showing still another embodiment, in which the blind end 53 is thickened like a glans and is reinforced with a stainless steel 94 having a thickness of 0.05 to 0.2 mm. However, except for this point, the outer shape is the same as that shown in FIG.

FIG. 18 is a view showing a cross section of still another embodiment and the dimensions and hardness of an optimum example thereof.
Reference numeral 0 denotes a pipe member having an outer diameter smaller than that of the end member 51. A solid rod 72 having the same diameter as the connecting member 71 is interposed at the center of the central member, and the central member 50 is divided into two right and left parts. ing. The length of the rod 72 is 2 to 6 mm, preferably 3 to 5 mm, and most preferably 3.5 to 4 mm. The transition portion 63 of the rod 72 and the central member 50 smoothly transitions at an inclination of 1 mm.

FIG. 19 is a sectional view showing still another embodiment, in which the central member 50 of the embodiment shown in FIG. 18 is not a pipe material but a solid rod. As shown at 17, the stainless steel 94 is used for reinforcement.

FIG. 20 is a perspective view showing the outer shape of the embodiment shown in FIGS.

FIG. 21 shows still another embodiment, wherein the center member 50 and the end member 51 are formed of a pipe material.
The outer diameter of the central member 50 is the same as that of the end member 51,
0, a solid rod 7 having the same diameter as the connecting member 71
2, the center member 50 is divided into two parts, left and right, and the boundary 63 between the rod 72 and the center member 50 is 1 mm in length and smoothly transitions so as not to form a step.

FIG. 22 shows still another embodiment. The outer shape is the same as that of the embodiment shown in FIG.
Is made of solid rods rather than pipe material.

FIG. 23 is a perspective view showing the outer shape of FIGS. 21 and 22.

FIG. 24 is a schematic diagram showing the state of the embodiment shown in FIGS. 21 and 22 when it is implemented.
The probe son 91 is inserted from to the blind end 53.

FIG. 25 is a conceptual diagram showing a state where the embodiment shown in FIGS. 21 and 22 is inserted into the lacrimal canal. FIG. 26 shows still another embodiment in which a drug is contained in the portion 31 in the nasolacrimal duct of the end member 51 shown in FIG.

FIG. 27 shows still another embodiment in which the central member 5 is provided.
0 has an outer diameter of 0.9 to 1.4 mm, preferably 1.0 to
The central member 50 is formed of a pipe material having a diameter larger by 0.1 to 0.3 mm than the outer diameter of the end member 51. And is divided into right and left by a rod 72 interposed in the center of the central member 50. The center member 50 may be a honeycomb structure or a solid rod as shown in FIG. 28 instead of the pipe material.

FIG. 29 is a conceptual diagram showing still another embodiment in which the same outer diameter as the embodiment shown in FIGS. 27 and 28 is inserted into the lacrimal canal. Lower canaliculus 14, part 3 of central member 50 in total canaliculus 15
2 contains a drug.

As shown in FIG. 30, the drug release device 25 comprises a drug storage section 22 as a drug core 22, a drug release film 21, and a support 24. The drug releasing device 25 for treating glaucoma has the same structure as that of the conventional occusate 25, but is 1/2 to 1/3 the size of the occusate 25, and is wound around the support 24 as shown in FIG. Attached,
It can be attached to and detached from the center of the center member 50 of the tube. In particular, those having the outer shapes shown in FIGS. 20 and 23 have the central member 50 divided into two on the left and right, and FIG.
As shown in FIG. 1 and FIG. 32, it is suitable for winding the drug release device 25. That is, the size of the drug release device 25 shown in FIG. 30 is 2 × 4.5 mm to 3 × 7 mm, and the drug release film 21 is made of a polymer film made of an ethylene vinyl acetate copolymer. 24 also consists of an ethylene acetate copolymer. The drug reservoir 22 contains a pilocarpine core as in the case of the occultate 25,
It is a preparation containing pilocarpine hydrochloride and alginic acid. Unlike the occultate 25, in the drug release device 25 of the present invention, it is not necessary to dye the support 24 with a white pigment, and a device provided with a drug release device 25 of another drug core instead of the pilocarpine core is used. In addition, the entire end member 51, the entire central member 50, and the connecting member 71 containing a drug are also used as a drug release device.

[0045]

According to the preferred lacrimal canal device of the present invention,
Since the outer diameter of the connecting member 71 is smaller than that of the center member 50 or the end member 51, when the center portion is lifted with tweezers, the shape becomes an inverted U-shape. Therefore, there is a very small possibility that tears will occur in the punctum or lacrimal canaliculus after placement. In addition, the central member 50 is about 10 to 20 (Shore A) harder than the conventional one, and is hard to be thin even when pulled, so that the punctum of the puncta or the lacrimal canaliculus hardly occurs after being placed. Further, since the connecting member 71 is thinner and more flexible than the end member 51 and the center member 50, the stability in the lacrimal passage is high, and trouble after placement is extremely small. The end member 51 is made of a hard material,
It is less likely to be pierced by the son 91. Further, by making the blind end 53 of the end member 51 thick and having a glans shape, the breakage by the probe 91 is further reduced. Further, the blind end portion 53 is further reinforced with the stainless steel 94, so that there is no fear of a punch-through accident due to the son 91. The reinforcing material 94 is not limited to stainless steel, but may be other metal or plastic reinforcing material 94. Further, the outer diameter of the central member 50 that is equal to or larger than the outer diameter of the end member 51 can be used instead of the punctal plug. Further, by impregnating the central member 50 with a glaucoma drug, it can be used as a drag delivery system for glaucoma.

When a thick central member 50 containing a drug is used as the drag delivery system, the central member 50 blocks the upper and lower canaliculus, so that even if the glaucoma drug contained in the central member 50 is released. Since the drug contained in the tear fluid does not flow into the lacrimal passage, the drug effect is increased. Further, by incorporating a drug into the end member 51, it can be used as a drag delivery system for the lacrimal sac or nasolacrimal duct.
When the middle member 50 or the end member 51 containing an antibiotic or antibacterial agent is used as a lacrimal stent for the treatment of lacrimal passage obstruction, the prevention and treatment of infection can be performed at the same time. Be strengthened. In addition, when the central member 50 or the end member 51 containing an antitumor agent such as 5-FU is used for treatment of lacrimal canal obstruction, reocclusion hardly occurs after removal. The use of the central member 50 containing a steroid agent is useful for treating uveitis. Also the central member 5
The one containing antibiotics, antibacterial agents and antiviral agents in 0 is useful for treating conjunctivitis and keratitis.

The device according to the present invention uses the large-sized or small-sized device of the present invention depending on the length of the lacrimal passage and the size of the lumen of the animal, thereby obstructing the lacrimal passage of the animal, glaucoma or dry eye. Can be used for treatment such as. When the occultate 25 for treating glaucoma is wrapped around the center of the central member 50 so as to be detachable, the occultate 25
Has improved ocular surface stability,
Will no longer be lost or dropped,
Patient's feeling of foreign body,
Fewer complaints of redness, lacrimation, eye oils, and eye pain. If necessary, two thin central members 50 can be inserted into the lacrimal tract, and the lacrimal tract can be further expanded.

The present invention is not limited to the above embodiment. For example, if the biocompatibility is good, the end member 51 is 80
Other plastics having higher hardness than (shore A) may be used. Also, if a certain flexibility is obtained,
The central member 50 may have a honeycomb structure. Also the central member 5
Instead of wrapping the drug release device 25 around the center member 50, a method of incorporating the drug release device 25 that can be attached to and detached from the central member 50 may be used. The method of attaching the drug release device 25 to the central member 50 narrows or closes the lacrimal passage by the central member 50 or the end member 51, and thus the released drug is not easily discharged to the lacrimal passage. The effect lasts for a long time.

[Brief description of drawings]

FIG. 1 is a schematic diagram showing a lacrimal passage.

FIG. 2 is a diagram showing a structure and a configuration of an occupate.

FIG. 3 is a schematic explanatory diagram for explaining a problem of a conventional technique.

FIG. 4 is a schematic explanatory diagram for explaining a problem of a conventional technique.

FIG. 5 is a sectional view showing an embodiment of a preferred lacrimal canal intubation device according to the present invention.

FIG. 6 is a cross-sectional view showing another embodiment of the lacrimal canal intubation device according to the present invention.

FIG. 7 is a perspective view showing the outer shape of the embodiment shown in FIGS. 5 and 6;

FIG. 8 is a sectional view showing still another embodiment of the lacrimal canal intubation device according to the present invention.

FIG. 9 is a sectional view showing still another embodiment of the present invention.

FIG. 10 is a perspective view showing a state when the embodiment shown in FIGS. 5, 6, 7, 8 and 9 is performed.

FIG. 11 is a conceptual diagram showing a state where the embodiment shown in FIGS. 5, 6, 7, 8 and 9 is inserted into a lacrimal canal;

FIG. 12 is a sectional view showing still another embodiment of the present invention.

FIG. 13 is a conceptual diagram showing a state in which the same outer shape as the embodiment shown in FIG. 12 is inserted into the lacrimal canal according to still another embodiment of the present invention.

FIG. 14 is a sectional view showing still another embodiment of the present invention.

FIG. 15 is a sectional view showing still another embodiment of the present invention.

FIG. 16 is a perspective view showing the outer shape of the embodiment shown in FIG. 14;

FIG. 17 is a sectional view showing still another embodiment of the present invention.

FIG. 18 is a cross-sectional view showing still another embodiment of the present invention, and shows dimensions and hardness of an optimum example.

FIG. 19 is a sectional view showing still another embodiment of the present invention.

FIG. 20 is a perspective view showing the outer shape of the embodiment shown in FIGS. 18 and 19;

FIG. 21 is a sectional view showing still another embodiment of the present invention.

FIG. 22 is a sectional view showing still another embodiment of the present invention.

FIG. 23 is a perspective view showing the outer shape of the embodiment shown in FIGS. 21 and 22;

FIG. 24 is a schematic diagram showing a state at the time of implementation of the embodiment shown in FIGS. 21 and 22;

FIG. 25 is a conceptual diagram showing a state in which the embodiment shown in FIGS. 28, 29 and 30 is inserted into a lacrimal canal;

FIG. 26 shows still another embodiment of the present invention.
The conceptual diagram which shows the state which inserted the thing of the same external shape as the Example shown in FIG. 2 in the lacrimal canal.

FIG. 27 is a sectional view showing still another embodiment of the present invention.

FIG. 28 is a sectional view showing still another embodiment of the present invention.

FIG. 29 shows still another embodiment of the present invention.
FIG. 9 is a conceptual diagram showing a state in which the same outer shape as the embodiment shown in FIG. 8 is inserted into the lacrimal canal.

FIG. 30 is a view showing another embodiment of the present invention, wherein (A) is a view showing the configuration of a drug release device with a curled state in a spread state, and (B) is an exploded view of the drug release device. FIG.

FIG. 31 shows how to use the embodiment shown in FIG. 30;
(A) shows a curled drug release device.
The drug release device can be mounted on the embodiment shown in FIGS. 5B is a perspective view showing a state in which the drug releasing device is mounted on the embodiment shown in FIG. 7, and FIG.
FIG. 2 is a cross-sectional view showing a state in which a drug release device is mounted on the embodiment shown in FIG.

FIG. 32 is a conceptual diagram showing a state where the embodiment shown in FIG. 31 is inserted into the lacrimal canal.

[Explanation of symbols] 11 upper punctum 12 lower punctum 13 upper lacrimal canal 14 lower lacrimal canal 15 total lacrimal canal 16 lacrimal sac 17 nasolacrimal duct 18 nostril 19 lacrimal gland 20 drug release device 21 drug release control membrane 21 polymer membrane 21 Ethylene vinyl acetate copolymer membrane 21 Drug release membrane 22 Drug reservoir 22 Pilocarpine core 23 Gap 24 White support 24 Support 25 Occuxate 25 Drug release device 30 Central part of central member between upper and lower punctum of,
Drug-containing part 31 Drug-containing part of end member in nasolacrimal duct 32 Drug-containing part of central member in tear canaliculus 40 Supple central part of conventional tube 41 Tears Tear of small tube 42 Tear of tube tip 50 Central member 51 End member 53 Terminal end 53 Blind end 53 Glans 55 Cuts 55 Cut 57 Mark 59 Center mark 60 Both ends of connecting member 61 Open end of end member 61 Adhesive part 62 Center Ends of member 62 Ends of central member 62 Adhesive part 71 Connecting member 72 Rod 91 Exsonator 92 Extinction gripping portion 93 Extinction tip 94 Stainless steel 94 Reinforcement material 94 Stainless steel reinforcement material 94 Plastic reinforcement material

Claims (24)

[Claims] An end member (51), a central member (50) disposed between the two end members (51), and each of the two end members (51) being a central member (50). A connecting member (71) for connecting the end members (51) is provided, each of the end members (51) has a cut (55) for inserting the probe (91), and is formed in a pipe shape. ) Is a blind end (53), the connecting member (71) is more flexible than the end member (51) and the center member (50), and the outer diameter of the connecting member (71) is smaller than that of the end member (51). Central member (5
A lacrimal canal intubation device characterized by being smaller than the outer diameter of 0). 2. The Shore hardness of the connecting member (71) is 20 to.
The end member (51) has a Shore hardness of 60 to 80 (Shore A), and the center member (50) has a Shore hardness of 20 to 80 (Shore A).
The lacrimal canal intubation device according to claim 1, wherein: 3. The connecting member (71) has a Shore hardness of 40 to 40.
The end member (51) has a Shore hardness of 60 to 80 (Shore A), and the center member (50) has a Shore hardness of 50 to 80 (Shore A).
The lacrimal canal intubation device according to claim 1, wherein: 4. The connecting member (71) has a Shore hardness of 50 to 50.
The end member (51) has a Shore hardness of 75 to 80 (Shore A), and the center member (50) has a Shore hardness of 60 to 75 (Shore A).
The lacrimal canal intubation device according to claim 1, wherein: 5. The connecting member (71), the end member (51) and the center member (50) are formed as one body.
5. The lacrimal canal intubation device according to any one of items 4 to 4. 6. The central part of the central member (50) has a diameter of 3 to 5 mm.
6. The portion of claim 1, wherein said portion is thin.
The lacrimal canal intubation device according to any one of the above. 7. The lacrimal canal intubation device according to claim 1, wherein the ends of the both end members are thickened in a glans manner. 8. The outer diameter of the center member (50) is equal to that of the end member (5).
2. An outer diameter equal to or larger than the outer diameter of 1), and is used as a punctum plug.
The lacrimal canal intubation device according to any one of claims 7 to 7. 9. The central member (50) is made of a soft material, and the central member (50) is configured to contain a drug and to be used as a drag delivery system.
The lacrimal canal intubation device according to any one of the above. 10. The lacrimal canal intubation device according to claim 1, wherein a drug is contained in the end member (51) to provide a drag delivery system for the lacrimal sac or nasolacrimal duct. 11. The lacrimal canal intubation according to claim 1, wherein the entire end members (51), the entire central member (50) and the entire connecting member (71) contain a drug. Appliances. 12. The lacrimal canal intubation device according to any one of claims 1 to 11, wherein the drug release device (25) is wound around the center of the central member (50) to form a drag delivery system. 13. The occultate (25) is connected to the central member (5).
The lacrimal canal intubation device according to any one of claims 1 to 11, wherein the device is detachably attached to the center of (0). 14. The blind end (53) is made of stainless steel (9).
The lacrimal canal intubation device according to any one of claims 1 to 11, which is reinforced in (4). 15. The lacrimal passage according to claim 1, wherein the connecting member (71), the end member (51) and the central member (50) are formed of silicone rubber. Intubation device. 16. An end member (51) and a central member (50) disposed between the two end members (51), wherein the number of the end members (51) and the central member (50) is reduced. A lacrimal canal intubation device, characterized in that one of them contains a drug. 17. A connecting member (71) for connecting each of the two end members (51) to the central member (50),
Shore hardness of the connecting member (71) is 20 to 80 (shor).
e A) and the Shore hardness of the end member (51) is 60 to
The lacrimal canal intubation device according to claim 16, characterized in that the central member (50) has a Shore hardness of 20 to 80 (Shore A). 18. The central part of the central member (50) has a length of 3 to 5 m.
The part of m is thin.
Or the lacrimal canal intubation device according to 17. 19. The lacrimal passage according to any one of claims 16 to 18, characterized in that the ends of both end members (51) are blind ends which are blunt-shaped and blunted and have a thick wall. Intubation equipment. 20. End members (51) and a center member (50)
The lacrimal intubation device according to claim 17, wherein a drug is contained in the connecting member (71). 21. The device of any one of claims 16 to 19, wherein the drug release device (25) is wound around the center of the central member (50) to form a drag delivery system. 22. The occupate (25) is connected to the central member (5).
20. The lacrimal canal intubation device according to any one of claims 16 to 19, which is detachably attached to the center of 0). The blind end (53) is made of stainless steel (9).
20. The lacrimal canal intubation device according to claim 19, wherein the device is reinforced in 4). 24. The lacrimal canal intubation device according to claim 17, wherein the connecting member (71), the end member (51) and the central member (50) are formed of silicone rubber.