Source: https://patents.google.com/patent/JP4280128B2/en
Timestamp: 2019-12-06 12:48:15
Document Index: 52311946

Matched Legal Cases: ['Application No. 2003', 'Application No. 2003', 'art 4', 'art 5', 'art 8', 'art 9']

JP4280128B2 - Punctum plug - Google Patents
JP4280128B2
JP4280128B2 JP2003295664A JP2003295664A JP4280128B2 JP 4280128 B2 JP4280128 B2 JP 4280128B2 JP 2003295664 A JP2003295664 A JP 2003295664A JP 2003295664 A JP2003295664 A JP 2003295664A JP 4280128 B2 JP4280128 B2 JP 4280128B2
JP2003295664A
JP2005058622A (en
2003-08-19 Application filed by 有限会社エム・エル・シー filed Critical 有限会社エム・エル・シー
2003-08-19 Priority to JP2003295664A priority Critical patent/JP4280128B2/en
2005-03-10 Publication of JP2005058622A publication Critical patent/JP2005058622A/en
2009-06-17 Publication of JP4280128B2 publication Critical patent/JP4280128B2/en
The present invention relates to a punctal plug suitable for the treatment of dry eye.
The present inventor is easy to operate and less painful to the patient for the treatment of dry eye, can be inserted accurately and quickly and safely, is more effective than the conventional one, is hard to come off, and has a good feeling of wearing For many years, we have been intensively researching intubation devices such as punctal plugs. For example, Japanese Patent Laid-Open No. 2000-70296, US Pat. US 6,383,192B.
As shown in FIG. 1, lacrimal fluid is secreted from the lacrimal gland (14), moisturizes the surface of the eyeball (17) where the cornea (15) and conjunctiva (16) are present, and then passes through the lacrimal passage to the lower nasal passage (18 ). The lacrimal passage consists of the upper punctum (1), the lower punctum (2), the upper lacrimal tubule vertical part (3), the lower lacrimal tubule vertical part (4), and the boundary between the upper lacrimal tubule vertical part and the horizontal part (5) , The border between the vertical part and the horizontal part of the lower lacrimal canal (6), the horizontal part of the upper lacrimal duct (7), the horizontal part of the lower lacrimal duct (8), the total lacrimal duct (9), the inner total punctum (10), the tears It consists of a sac (11) and a nasolacrimal duct (12). The lower end (13) of the nasolacrimal duct (12) is open to the lower nasal passage (18). The shape of the lumen of the lacrimal tubule horizontal portion (7), (8) is a spindle shape. It is known that negative pressure is generated in the tear canal lumen. For example, Katsuaki Kurihashi: Dacology-Clinical tears-. Medical Samurai Publishing, Tokyo, 1998. reference.
Size of the opening of the punctum is 0.1 to 0.8 mm 2 (average of about 0.3 mm 2). For example, Carter KD et al: Size variation of the laminar punctum in adults. Ophthalmic Plast Reconst Surg 4: 231, 1988. reference. The diameter of the Japanese punctum opening is 0.1 to 0.5 mm. For example, Shikako Suzuki: Research on slit lamp examination for eye diseases, 2nd stage, research on punctum. Clinical ophthalmology 10: 114, 1956. reference. The vertical portion of the lacrimal canal has a much larger cavity than the punctum. Even if the opening of the punctum is small, the lumen of the vertical part of the lacrimal tubule is wide. If the opening of the punctum is reduced, the lumen of the vertical portion of the lacrimal canal is not reduced proportionally.
In dry eye patients with reduced lacrimal gland function (14) and lack of tears, tears that are very important to the eye are quickly drained through the lacrimal passage. In order to suppress such discharge of tears, the upper punctum (1) and the lower punctum (2) are closed with an electrocoagulator or the punctum plug made of silicone is connected to the upper punctum (1) or Closing at the lower punctum (2) is performed. In this way, by closing the upper punctum (1) and lower punctum (2), even in dry eye patients lacking tears, tears will accumulate in the conjunctival sac of the eye, Dry eye symptoms often disappear.
For treatment of dry eye, a punctal plug composed of a collar (23), a shaft (22), and a tip (21) in FIG. 2 is used. As shown in FIG. 3, the punctum plug is inserted from the upper punctum (1) or the lower punctum (2). When inserted correctly, the collar (23) is inserted into the upper punctum (1) or the lower punctum (2). The shaft (22) and the tip (21) are in close contact with the punctum (1) and (2), and the shaft (22) and the tip (21) are in the upper tubule vertical section (3) and the lower punctum tubule vertical section (4). The tip (21) is large enough to fill the lumen of the vertical canalicular tubule, preventing tears from flowing into the canalicular tubule and maintaining the stability of the punctum plug. ing. The collar (23) not only fixes the punctal plug, but also helps to prevent tear fluid from flowing into the tubule.
In the conventional punctum plug, the diameter of the brim (23) is equal to or greater than the diameter of the tip (21). The group of punctal plugs shown in FIG. 4 is currently sold by Eagle Vision. As shown in FIG. 4, the punctum plug made by Eagle Vision has the same diameter as the tip (21) of the brim (23) (see Special Table 2002-529144). As shown in FIG. 4, the smallest one has a diameter of the flange (23) of 0.4 mm, and the diameter of the tip (21) is 0.4 mm accordingly. Since this punctum plug has a small flange (23) of 0.4 mm, the punctum is expanded at the tip (21) inserted before the collar (23), and the collar (23) is inserted when inserted as shown in FIG. ) Easily enters the lacrimal tubule through the punctum opening. Therefore, the diameter of the tip (21) is 0.4 mm, which is the same as the diameter of the brim. However, the diameter of the tip part (21) of 0.4 mm is too small compared to the size of the lumen of the vertical part of the lacrimal canal, so that the punctal plug is not stable and easy to come out. Can not be prevented from flowing into the lacrimal passage. In this small punctum plug, the diameter of the tip (21) is set to 0.4 mm, which is the same as the diameter of the collar (23), because the collar (23) tears from the punctum expanded at the tip (21) when inserted. This is because the diameter of the tip (21) could not be increased to 0.4 mm or more because of fear of entering the small tube. If the diameter of the tip (21) is larger than 0.4 mm, the punctum (1), (2) is expanded by the tip (21), and the small brim (23) is expanded punctum (1), From (2), it easily enters the lacrimal tubule, and the result is that the collar (23) cannot be pulled out easily.
When the diameter of the punctal opening is 0.1 mm, the diameter of the brim (23) and the tip (21) is usually 0.3 mm in diameter than the punctal plug with a diameter of 0.4 mm. The punctal plug with a 1 mm tip (21) is better, but when this plug is inserted without thread through the plug according to the prior art, the small brim (23) is inserted into the large tip (21). From the punctum (1), (2) expanded by, it easily enters the lacrimal tubule and has difficulty in removing the plug.
As shown in FIG. 4, a large punctum plug made by Eagle Vision has the same diameter of the flange (23) and the tip (21) and is 1.1 mm. When the brim (23) becomes large, the edge of the brim (23) hits the surface of the eyeball and the feeling of wearing becomes worse. On the other hand, when the size of the brim (23) is reduced and the size of the tip (21) is 1.1 mm as it is, in the punctal plug that does not use a conventional thread, the tip (21) A small brim (23) easily enters the lacrimal tubule from the opening of the punctum expanded by insertion. When the brim (23) enters the lacrimal canal, the punctal plug becomes completely invisible, but in order to remove it, the punctum and lacrimal canal are incised under a surgical microscope, and the plug is removed and sutured. It must be time consuming.
At present, the punctal plug that has entered the lacrimal passage is often left without being removed. If left untreated, lacrimal inflammation may occur. Due to stimulation of the punctal plug, the lacrimal tubule may be blocked between the lacrimal tubule vertical portions (3) and (4) and the lacrimal tubule horizontal portions (7) and (8). (For example, Fayet B, et al: Canalical synthesises the insertion of lacrimal plugs. Incidence and machinery. J Fr Ophthalmol 15: 25-33, 1992). The present inventor has already invented a punctal plug with a protrusion through a thread for the purpose of preventing occlusion of the lacrimal canal (Kuriaki Katsuaki: Japanese Patent Application 2003-154328, Japanese Patent Application 2003-198779).
JP 2000-70296 A U.S. Pat. US 6,383,192B Japanese Patent Application No. 2003-154328 Japanese Patent Application No. 2003-198779 Special Table 2002-529144 Kuriaki Kuriaki, "Dacriology-Clinical Lacrimation-" Medical Tatsu Publishing 1998 Carter KD et al: Size variation of the lacrimal punctum in adults. Ophthalmic Plast Reconstr Surg 4: 231, 1988 Shikako Suzuki "Study on slit lamp examination for eye disease, 2nd stage, Study on punctum" Clinical Ophthalmology 10: 114 1956 Fayet B, et al: Canalicular stenoses complicating the insertion oflacrimal plugs. Incidence and mechanisms.J Fr Ophthalmol 15: 25-33, 1992
The first problem to be solved is that in the conventional technique, when the collar (23) enters the lacrimal canal at the time of insertion, the collar (23) cannot be pulled out easily.
The second problem to be solved is that in the conventional technique, when the tip (21) is made sufficiently large, the punctum expands at the tip (21), and the collar (23) moves from the punctum to the punctum tubule. The collar (23) cannot be made sufficiently small according to the size of the opening of the individual punctum.
A third problem to be solved is that in the conventional punctal plug, there may be a blockage between the vertical part of the lacrimal canal and the horizontal part.
The solution of the present invention comprises a shaft (22), a sufficiently large tip (21) attached to one end of the shaft (22), and a sufficiently small flange (23) attached to the other end of the shaft (22). The punctum is characterized in that the diameter of the tip (21) is larger than the diameter of the flange (23) and a thin member, for example, a thread (31) is provided on the shaft (22) or the tip (21). It is a plug. A preferable example of the thin member is a thread having a diameter of 0.05 mm or less, for example, a 9-0 nylon thread. The tip (21) has a projection (91).
As shown in FIGS. 6 to 20, the punctal plug according to the present invention has a thread, so that even if a small brim (23) enters the lacrimal canal, it can be easily pulled out and placed correctly. Therefore, a punctal plug having a sufficiently small brim (23) and a sufficiently large tip (21) suitable for an individual can be selected from a large number of punctal plugs. In the punctal plug according to the present invention, the brim (23) may enter the tubule, so that the punctal point can be expanded with a punctal expansion needle before insertion, so that the plug can be easily inserted. . Since it has a sufficiently large tip portion (21), not only can the vertical portion of the lacrimal canal be sufficiently blocked to prevent the inflow of tears into the lacrimal passage, but the stability of the plug is improved. Moreover, since the collar (23) is sufficiently small, it does not hit the surface of the eye and is comfortable to wear.
In an embodiment of the invention, the punctal plug is made of plastic, preferably soft plastic. A tip (21) is attached to one end of the shaft (22). A flange (23) is attached to the other end of the shaft (22). A thread (31) is passed through the shaft (22) and the tip (21).
As shown in FIG. 11, since the punctal plug of the present invention has a thread (31), even when the collar (23) enters the lacrimal tubule during insertion, the punctum (1), (2) By simultaneously pulling both sides of the thread (31) coming out from the tweezers with tweezers, the collar (23) can be taken out and the plug can be properly placed. Once the head (23) has gone out, it will not enter the lacrimal canal again.
Since the punctal plug of the present invention has a thread (31), even if the brim (23) enters the lacrimal tubule, the brim (23) is pulled out by pulling the both sides of the thread (31), and the punctal plug Can be placed correctly. Immediately after inserting the tip (21) having a diameter larger than the diameter of the collar (23), the opening of the punctum is enlarged, but soon returns to the original small opening, and the collar (23) tears. It never goes into the small tube.
Therefore, the punctal plug with thread of the present invention has a tip (21) having a sufficient size corresponding to the size of the lumen of the individual individual canalicular tubule, and the size of the individual's punctum is large. Since the punctal plug having a sufficiently small brim (23) can be obtained, the punctal plug has much better stability, and since the brim is small, it does not hit the surface of the eye and the feeling of wearing is improved.
Furthermore, as shown in FIGS. 12 and 13, by attaching the protrusion (91) to the tip (21), the brim (23) is less likely to enter the lacrimal canal. Further, the protrusion (91) prevents the punctal canal blockage, which is a complication of the punctal plug. Since the punctum plug according to the present invention may enter the lacrimal tubule during insertion, the punctum can be greatly expanded with the punctum expansion needle before insertion. A punctal plug can be easily inserted by expanding the punctum.
In the embodiment according to the present invention shown in FIGS. 6 to 11, the thread (31) is passed through the shaft (22) and the tip (21) of the punctum plug, and the diameter (b) of the collar (23) is It is smaller than the diameter (a) of the tip (21). Although FIG. 9 shows a group of punctal plugs according to the present invention in which the shaft (22) is in an accordion shape, the size of the punctal plugs is not limited to the numbers shown in FIG. As shown in FIG. 10, the punctal plug according to the present invention does not necessarily require the shaft (22) to have an accordion shape. The size of the punctal plug according to the present invention is not limited to the numbers shown in FIG. As shown in Fig. 11, even if the collar (23) enters the lacrimal tubule during insertion, pull the collar (23) at the same time with tweezers etc. to bring the collar (23) out and place the punctum plug correctly. can do. In the present invention, the collar (23) may enter the lacrimal tubule, so that the punctum can be greatly expanded with the punctum expansion needle before insertion, so that the punctal plug can be easily inserted. FIG. 9 shows a group of the present invention in which the shaft (22) has an accordion shape, and the diameter of the brim (23) is larger than the diameter of the tip (21), and the tears of the individual person are among them. The optimum one can be selected according to the size of the dot or the vertical part of the lacrimal canal. FIG. 10 shows a group of punctal plugs according to the present invention, wherein the shaft (22) has a taper shape.
In Example 2 by this invention shown by FIGS. 12-20, the processus | protrusion (91) is attached to the front-end | tip part (21) of a punctum plug, and also the thread | yarn (31) is let the shaft (22) pass. As shown in FIG. 21, the protrusion (91) enters the horizontal portion of the lacrimal canal. It is preferable that the attachment portion of the protrusion (91) extends over substantially the entire side surface of the tip portion (21). The length of the protrusion is 1.5 to 3 mm. This punctal plug with protrusions can be easily inserted into the tubule by means of an inserter in the same manner as a punctal plug without protrusions.
By attaching the protrusion (91) to the tip (21), not only can the lacrimal canal obstruction, which is a complication of the punctal plug, be prevented, but the brim (23) is less likely to enter the lacrimal canal when the punctal plug is inserted. Become.
The tip of the protrusion (91) is pointed so that it can be easily inserted from the punctum. FIG. 14 shows a typical example of a punctal plug with a protrusion through a thread according to the present invention, and the shaft (22) has an accordion shape.
The size and form of the protrusion (91) are not limited to those described above. FIG. 16 shows a group of punctal plugs with protrusions through a thread according to the present invention, with the shaft (22) in the form of an accordion. FIG. 17 shows a group of protruding punctal plugs through which the thread is passed according to the present invention, but the shaft (22) has a taper shape. In the group of punctal plugs according to the present invention shown in FIGS. 16 and 17, the diameters of the brim (23) and the tip (21) are shown, but the diameters of the brim (23) and the tip (21) are It is not limited to these numbers.
FIG. 18 shows another embodiment of the present inventor, in which a thread is passed and the diameter of the brim (23) is smaller than the diameter of the tip (21). Further, the shaft (22) is not tapered, the tip (21) is spherical and has a protrusion (91) on the side.
FIG. 19 shows a group of punctal plugs according to the invention shown in FIG. 18, but the invention is not limited to the numbers described in FIG.
Also in the punctal plug of FIG. 18A, the diameter of the brim (23) is smaller than the diameter of the tip (21). The diameter of the shaft (22) is 0.2 to 0.8 mm, the shaft (22) is straight, the length is 0.5 to 1.5 mm, and the diameter of the spherical tip (21) is 0. .7 to 1.5 mm. The length of the protrusion (91) attached to the tip (21) is 1.5 to 3 mm. As shown in FIG. 18B, the shaft (22) may have a taper shape. As shown in FIG. 18C, the shaft (22) may have an accordion shape. FIG. 19 shows a group of punctal plugs of the present invention by the present inventor. The tip (21) has a spherical shape, and the diameter of the tip (21) is larger than the diameter of the flange (23). It is large and thread (31) is threaded through it. Dry eye patients can select the most suitable one from this group of punctal plugs with a sufficiently small brim (23) and a sufficiently large tip (21). In addition, this invention is not limited to the number which shows the magnitude | size described in FIG.
In a punctal plug with a protrusion through which a thread is passed, the tip of a sharp protrusion (91) is inserted from the punctum into the horizontal portion of the lacrimal canal via the vertical portion of the lacrimal canal, and the tip (21) and the shaft (22) are inserted. Push into the vertical part of the lacrimal canal. If the brim (23) enters the lacrimal tubule, pull both sides of the thread (31), take the brim (23) out and place it correctly.
In the punctal plug with the protrusion (91), the brim (23) is less likely to enter the lacrimal canal compared to the punctal plug without the protrusion (91).
By passing the thread (31) through the punctal plug as described above, not only can the plug be safely and securely placed, but also a sufficiently small brim (23) corresponding to the size of the individual punctum or tubule It can be in an ideal shape with a sufficiently large tip (21).
By passing the thread (31) through the punctal plug for dry eye treatment, the punctal plug collar (23) that has entered the punctum tubule at the time of insertion can be pulled out and placed correctly. The plug collar (23) can be made sufficiently small to improve wearing comfort, and the tip (21) can be made sufficiently large. By creating a large number of plugs of different sizes, an ideal punctal plug according to the size of the opening of the punctum of an individual person or the size of the lumen of the vertical part of the punctum canal You can choose from.
Schematic showing the lacrimal passage Schematic showing a conventional punctal plug Schematic for explaining the implementation method of a conventional punctal plug Schematic showing that the diameter of the flange (23) and the tip (21) of the conventional punctum plug is the same Explanatory drawing which shows the failure example that the collar (23) of the conventional punctum plug will enter the lacrimal tubule Schematic showing an example of punctal plug through thread (31) of the present invention Schematic showing another example of punctal plug through thread (31) of the present invention Sectional drawing which shows an example of the punctum plug through the thread | yarn (31) of this invention Schematic showing a group of punctum plugs with a punctum plug through the thread (31) according to the present invention, wherein the brim (23) has a smaller diameter than the tip (21). Schematic showing a group of punctum plugs with a punctum plug through the thread (31) according to the present invention, wherein the brim (23) has a smaller diameter than the tip (21). Explanatory drawing which shows the insertion method of the punctal plug through the thread | yarn (31) of this invention Schematic which shows an example of the punctal plug which has the thread | yarn (31) and protrusion (91) of this invention. Schematic which shows an example of the punctal plug which has the thread | yarn (31) and protrusion (91) of this invention. Sectional drawing which shows an example of the punctal plug which has the thread | yarn (31) and protrusion (91) of this invention Sectional drawing which shows an example of the punctal plug which has the thread | yarn (31) and protrusion (91) of this invention Schematic showing a group of punctum plugs with a punctum plug having a thread (31) and a protrusion (91) according to the present invention, the diameter of the brim (23) being smaller than the diameter of the tip (21). Schematic showing a group of punctal plugs with a punctal plug having a thread (31) and a protrusion (91) according to the present invention, wherein the collar (23) has a smaller diameter than the tip (21). (A) is a punctum plug through the thread (31) according to the present invention, showing an example of a punctum plug with a straight shaft (22), a spherical tip (21) and a protrusion (91). In the figure, (B) shows the shaft (22) in a taper shape, and (C) shows the shaft (22) in an accordion shape. A punctum with a punctum plug having a thread (31), a spherical tip (21) and a protrusion (91) attached to the thread (31) according to the present invention, the diameter of the collar (23) being smaller than the diameter of the tip (21) Schematic showing a group of plugs Schematic for explaining a method of implementing a punctal plug having a thread (31) and a protrusion (91) of the present invention
DESCRIPTION OF SYMBOLS 1 Upper punctum 2 Lower punctum 3 Upper lacrimal tubule vertical part 4 Lower lacrimal tubule vertical part 5 Upper lacrimal tubule vertical part and horizontal part boundary 6 Lower lacrimal tubule vertical part and horizontal part boundary 7 Upper lacrimal tubule horizontal part 8 Lacrimal canal horizontal part 9 Total lacrimal duct 10 Internal punctum 11 Lacrimal sac 12 Nasal lacrimal duct 13 Lower end of nasolacrimal duct 14 Lacrimal gland 15 Cornea 16 Conjunctiva 17 Eyeball surface 18 Inferior nasal passage 21 Tip 22 Shaft 23 Tail 24 Hole 31 Thread (thin material)
91 Pointed member (protrusion) attached to the tip (21)
A number of punctum plugs having a shaft (22), a tip (21) attached to one end of the shaft (22), and a flange (23) attached to the other end of the shaft (22) are sized to each other . A different group of punctal plugs are formed , and a thin thread (31) is provided on the shaft (22) or the tip (21) of each of the punctal plugs. 23) has a diameter (b) smaller than the diameter (a) of the tip portion (21) , the tip portion (21) has a protrusion (91), and the middle of the thread (31) is in the punctum plug. And both ends of the thread are protruding from the punctum plug, and by pulling one end side of the thread (31) provided on the punctum plug, the entire thread (31) is It can be pulled out from the plug, When the collar (23) of the point plug has entered the lacrimal passage, the collar (23) can be pulled out of the lacrimal passage by simultaneously pulling both ends of the thread (31). punctal plug, characterized in that there.
When a thin thread (31) is passed from the hole (24) of the collar (23) to the shaft (22) near the collar (23) and the collar (23) enters the lacrimal canal, the thread (31 by pulling both ends of), pull the collar (23), punctal plug according to claim 1, characterized in that it removed the yarn after indwelling correctly.
The diameter of a front-end | tip part (21) is 0.8-1.5mm, a collar (23) is a disk shape , The diameter is 0.3-1.0mm , The diameter of Claim 1 or 2 characterized by the above-mentioned. Punctum plug.
The punctum plug according to any one of claims 1, 2, and 3, wherein the tip (21) has a spherical shape.
JP2003295664A 2003-08-19 2003-08-19 Punctum plug Expired - Fee Related JP4280128B2 (en)
JP2003295664A JP4280128B2 (en) 2003-08-19 2003-08-19 Punctum plug
JP2005058622A JP2005058622A (en) 2005-03-10
JP4280128B2 true JP4280128B2 (en) 2009-06-17
ID=34371824
JP2003295664A Expired - Fee Related JP4280128B2 (en) 2003-08-19 2003-08-19 Punctum plug
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