WO2015111554A1

WO2015111554A1 - Tear duct tube

Info

Publication number: WO2015111554A1
Application number: PCT/JP2015/051275
Authority: WO
Inventors: 千尋古賀; 荻野　英司; 文康平井; 深谷　浩平; 偉一宮内; 真梨子松本
Original assignee: 株式会社カネカ
Priority date: 2014-01-22
Filing date: 2015-01-19
Publication date: 2015-07-30
Also published as: JPWO2015111554A1; JP6581909B2

Abstract

A tear duct tube comprising a pair of tube-shaped members with an opening at one end that communicates with the lumen and a connecting member for connecting the other ends of said tube-shaped members to each other. The tip comprising one end of at least one of the tube-shaped members is formed from a colorless material. On a portion of the circumference of the tip that is formed from the colorless material, a colored section is formed along the longitudinal direction of the tube-shaped member. The hue of the one tube-shaped member of the pair of tube-shaped members is a complementary hue or an adjacent complementary hue with respect to the hue of the colored section in the color wheel.

Description

Lacrimal tube

The present invention relates to a lacrimal tube used for lacrimal passage obstruction treatment.

For treatment of lacrimal passage obstruction leading to lacrimation, (i) probing with lacrimal passage bougie, (ii) placement of lacrimal duct tube, (iii) lacrimal nasal sinus anastomosis (DCR), (iv) lacrimal tubuloplasty , (V) nasolacrimal duct arthroplasty, (vi) lacrimal cone movement.

The probing by the lacrimal passage bougie (i) described above is to open the occluded site by inserting a capillary tube called a bougie into the lacrimal passage and reconstruct the tear fluid flow path. The (ii) lacrimal tube used later is an intra lacrimal intubation device that is placed in order to maintain the flow path and reconstruct the tissue. Since these treatments are easy and minimally invasive, they are often performed as the first treatment. In contrast, (iii) lacrimal nasal sinus anastomosis (DCR), (iv) lacrimal tube formation, (v) nasolacrimal duct surgery, and (vi) lacrimal mobilization are highly effective, Since the incision is made and the hole is made in the bone, the degree of invasiveness is relatively high, and it is performed as a final means.

The lacrimal tube used in (ii) is placed in order to maintain the flow path and reconstruct the tissue after probing with the lacrimal bougie in (i). The placement of the lacrimal duct tube of (ii) is easier, less invasive and more effective than the treatment methods (iii) to (vi) described above. Among them, as shown in Patent Document 1, a lacrimal duct tube is formed of a thin and soft tube or rod at the center of the tube, and a hard and thick tube on both sides thereof (see, for example,

Patent Documents

1, 2, and 3). ) Is widely spread.

The lacrimal duct tube consists of a tube and a pair of bougies inserted from the cuts on both sides of the tube, and the bougie is operated to guide the tube into the lacrimal tract and place it. As shown in FIG. 3, the lacrimal passage is composed of the punctum (21, 22), lacrimal canal (23, 24), lacrimal sac (26), nasolacrimal duct (27), and the like. A lacrimal tube is inserted into the lacrimal passage.

However, in order to insert the lacrimal tube, the operation inside the lacrimal passage using a bougie must be performed in a groping state that relies on the sense of the operator's fingertips, and the operator has advanced operation technology. Otherwise, the bougie may break through the tube or make a hole other than the normal lacrimal tract (temporary tract), in which case the treatment results were poor.

Therefore, in the field of lacrimal passage obstruction treatment in recent years, from the viewpoint of performing safer and more reliable treatment, as the lacrimal tube insertion, sheath-guided endoscopic puncture (SEP) and sheath-guided tube insertion (SGI) ) Is combined with the insertion technique.

In SEP, a Teflon (registered trademark) or polyurethane outer sheath covering the lacrimal endoscope is inserted into the punctum before the lacrimal endoscope, and the inside of the lacrimal passage is observed with the lacrimal endoscope The occlusion portion is punctured, and then the insertion is performed until the sheath tip comes out from the opening of the nasolacrimal duct, and then only the lacrimal endoscope is removed while leaving the sheath. For example, as shown in FIGS. 1A and 1B, a sheath 30 attached to the lacrimal endoscope 29 is blocked by the lower nasal passage 28 of the lacrimal passage 31 from the upper punctum 21 through the upper lacrimal tubule 23. After inserting into the occlusion site 32 and penetrating through the occlusion site 32, the lacrimal endoscope 29 is removed.

In SGI, the lacrimal tube is connected to the end of the punctum-side sheath inserted in the SEP, and the sheath tip that has come out of the occluded portion is pinched with forceps under nasal endoscopy. As a result, the lacrimal duct tube is pulled by the sheath and inserted into the space of the closed portion opened by SEP. Thereafter, the connection between the sheath and the lacrimal duct tube is removed, and the placement is completed. For example, the lacrimal tube 33 is connected to the sheath 30 as shown in FIG. 2 (a), and the sheath 30 is connected to the side opposite to the side where the lacrimal tube 33 is connected as shown in FIG. 2 (b). By pulling, the lacrimal duct tube 33 is inserted into the lacrimal passage 31 to penetrate the occlusion site 32. Next, as shown in FIG. 2C, the sheath 30 is removed and the lacrimal tube 33 is placed in the lacrimal passage 31.

Next, although not shown, another sheath 30 attached to the lacrimal endoscope 29 is located in the lower nasal passage 28 of the lacrimal passage 31 from the lower lacrimal point 22 where the lacrimal passage tube 33 is not inserted, through the lower lacrimal tubule 24. After inserting into the occlusion site 32 and penetrating through the occlusion site 32, the lacrimal endoscope 29 is removed, and the end of the lacrimal tube 33 that does not penetrate the occlusion site 32 is connected to the sheath 30, The sheath 30 is pulled from the side opposite to the side where the lacrimal tube 33 is connected to penetrate the other end of the lacrimal tube 33, and finally the sheath 30 is removed, as shown in FIG. The canal tube 33 is placed in the lacrimal passage 31.

The insertion method combining the SEP and SGI is not a blind method as in the prior art, but is an excellent safety method in that the puncture of the occlusion can be performed under a lacrimal endoscope. In addition, since the sheath used for SEP is made of a highly rigid material, the manipulation from the hand and the force can be transmitted directly to the tip for fine manipulation, and the lacrimal endoscope can be broken during the operation. There is an advantage that there is little risk that the tip fiber is broken.
However, in the procedure using the conventional sheath described above, it is difficult to insert a sheath into a lacrimal passage that is dark and obstructed with an intricate shape, even if a lacrimal endoscope is used. However, there was a possibility that it would pierce and form a temporary road, or insert it into the original temporary road by mistake.

Japanese Patent No. 2539325 Japanese Patent No. 3558924 JP 2004-202276 A

In view of the circumstances as described above, the object of the present invention is to provide a lacrimal tube that can be suitably used for the treatment of lacrimal passage obstruction similar to SEP, specifically, when performing a procedure by attaching to a lacrimal endoscope. Easily confirm your own tip position and lacrimal tract occlusion, and easily and safely treat lacrimal tract occlusion by using a portion of the lacrimal tube inserted and indwelled at the time of insertion later. To provide a lacrimal tube.

The present inventors have intensively studied to solve such problems. As a result, paying attention to the end portion at one end of the tube-shaped member constituting the lacrimal tube, and providing a colored portion at the end portion, the lacrimal tube is surely placed at a desired position even when operated in the dark lacrimal passage Has been found to be able to be inserted, and the present invention has been completed.

That is, the gist of the present invention is as follows.

[1] A lacrimal duct tube comprising a pair of tubular members having an opening communicating with the lumen at one end, and a connecting member connecting the other ends of the tubular members,
A terminal portion including one end of at least one of the tubular members is formed of a colorless material,
A colored portion along the longitudinal direction of the tubular member is formed on a part of the periphery of the end portion formed of the colorless material,
A lacrimal duct tube, wherein a hue of one tube-shaped member of the pair of tube-shaped members is a complementary color hue or an adjacent complementary color hue with respect to the hue of the colored portion in a hue ring.

[2] The lacrimal duct tube according to [1], wherein the colored portion is formed up to the one end.

[3] The lacrimal duct tube according to [1] or [2], wherein the colored portion is a series of lines or broken lines.

[4] The lacrimal duct tube according to any one of [1] to [3], wherein the colored portion has a width of 1/50 or more and 1/3 or less with respect to the entire peripheral length of the end portion.

[5] The colored portion in the tubular member is formed on the same side as the position of the entrance / exit on the other end side of the tubular member in the circumferential direction of the tubular member and at least one side opposite to the position. The lacrimal duct tube according to any one of [1] to [4].

[6] The colored portion is formed on the same side as the position of the entrance / exit in the circumferential direction of the tubular member and on the opposite side, and the width of one colored portion is different from the width of the other colored portion. The lacrimal duct tube according to [5] above.

[7] The colored portion having a narrow width is formed on the same side as the position of the entrance / exit in the circumferential direction of the tubular member, and the colored portion having a large width is formed on the opposite side. Lacrimal duct tube.

[8] The lacrimal duct tube according to any one of [1] to [7], wherein the colored tubular member is yellow and the colored portion is blue.

According to the lacrimal duct tube of the present invention, the distal end portion including one end of at least one of the tubular members is formed of a colorless material, so that the lacrimal duct endoscope is inserted into the lacrimal duct tube during the procedure. Can be ensured.
Further, by forming a colored portion along the longitudinal direction of the tubular member in a part of the periphery of the distal portion formed of the colorless material, the distal portion of the distal portion can be observed under the observation of the lacrimal endoscope during the procedure. The position can be easily confirmed.
Further, the tube inserted in the dark environment in the lacrimal passage is that the hue of the tube-shaped member of the lacrimal passage tube of the present invention is a complementary hue or an adjacent complementary hue with respect to the hue of the colored portion in the hue ring The specific position of the member can be easily confirmed.

It is a schematic explanatory drawing which shows an example of the surgery of the lacrimal passage obstruction | occlusion part based on SEP. It is a schematic explanatory drawing which shows an example of the surgery of the lacrimal passage obstruction | occlusion part based on SGI. It is explanatory drawing which shows the state in which the anatomical structure of the lacrimal passage and the lacrimal passage obturator were detained. It is the schematic which shows an example of the lacrimal duct tube of this invention. It is the schematic which shows an example of the lacrimal duct tube of this invention. It is the schematic which shows an example of the lacrimal duct tube of this invention. It is the schematic which shows an example of the lacrimal duct tube of this invention. It is the schematic which shows an example of the coloring part formed in the terminal part of the lacrimal duct tube of this invention. It is the schematic which shows an example of the lacrimal duct tube of this invention.

Hereinafter, the present invention will be described in detail.

As shown in FIG. 3, the lacrimal passage referred to in the present invention is the upper / lower punctum (21/22), upper / lower lacrimal duct (23/24), total lacrimal duct (25), lacrimal sac (26) , Lacrimal duct (27), nasal duct (not shown), Hasner's valve (not shown), and tears produced from the lacrimal gland (not shown) are transferred from the ocular surface to the lower nasal passage (28 ) Is a tube (eyeball appendage) that leads to FIG. 3 schematically shows the anatomical structure of the lacrimal passage. The tube leading from the upper punctum (21) to the lower nasal passage (28) through the upper lacrimal canal (23) and the total lacrimal canal (25) is called the upper lacrimal passage. The duct leading to the lower nasal passage (28) through the lacrimal canal (24) and the total lacrimal duct (25) is called the lower lacrimal passage.

The lacrimal tube of the present invention is a lacrimal tube including a pair of tubular members having an opening communicating with the lumen at one end, and a connecting member connecting the other ends of the tubular members,
A terminal portion including one end of at least one of the tubular members is formed of a colorless material,
A colored portion along the longitudinal direction of the tubular member is formed on a part of the periphery of the end portion formed of the colorless material,
The hue of one tubular member of the pair of tubular members is a complementary color hue or an adjacent complementary hue with respect to the hue of the colored portion in a hue ring.

The structure of the tubular member may be an integrated tube made of the same resin composition, a laminated structure in which a plurality of layers of different types of resin are laminated in the thickness direction, or a plurality of tubes of different types of resin May be a tube having a row structure in which are connected in the longitudinal direction.

The resin constituting the tubular member is not particularly limited, and examples thereof include polyethylene, silicone, polyamide elastomer, polyurethane, isobutylene copolymers, and resin compositions containing these alloys. It is not limited.
In the present invention, the alloy is not particularly limited. For example, when an alloy of polyurethane and an isobutylene copolymer is used, the isobutylene block copolymer (A), the thermoplastic polyurethane resin (B), and The hardness of the tube can be adjusted by adjusting the ratio. The greater the ratio of the thermoplastic polyurethane resin (B), the greater the hardness of the tube. In view of antithrombogenicity, surface slipperiness, and flexibility, the isobutylene block copolymer (A) is preferably contained in an amount of 1% by weight or more (that is, the isobutylene block copolymer (A ) And the thermoplastic polyurethane resin (B) are in a weight ratio (A) / (B) = 1/99 to 99/1). Among these, from the viewpoint of wear resistance, the ratio of the isobutylene block copolymer (A) and the thermoplastic polyurethane resin (B) is (A) / (B) = 1/99 to 70 / weight ratio. 30 is preferable. In particular, from the viewpoint of compressive stress, the ratio of the isobutylene block copolymer (A) to the thermoplastic polyurethane resin (B) is (A) / (B) = 1/99 to 50/50 in weight ratio. It is preferable that The resin composition for an integral tube used in the present invention may be composed of only the isobutylene block copolymer (A) and the thermoplastic polyurethane resin (B), but may be mixed with other components.

As the isobutylene block copolymer (A), “SIBSTAR102T” manufactured by Kaneka Corporation, which is a styrene-isobutylene-styrene block copolymer (hereinafter sometimes referred to as SIBS), is preferable. As the thermoplastic polyurethane resin (B) (hereinafter sometimes referred to as TPU), “Milactolan E385PNAT” manufactured by Nippon Milactolan, which is an ether type aromatic cyclic polyurethane, “Tecotan TT1074A” manufactured by Lubrizol, or ether type alicyclic type “Tecoflex EG100A” and “Tecoflex EG85A” manufactured by Lubrizol, which are polyurethanes, and “Calbutton PC3575A” manufactured by Lubrizol, which is a polycarbonate-based polyurethane, are preferable.

When the tube-shaped member is a tube having a laminated structure in the thickness direction, the resin used for each layer may be changed. For example, for the inner layer, it is preferable to use polyethylene as a highly rigid resin in order to improve the pushability of the lacrimal duct tube during insertion. In addition, it is preferable to use polyurethane as a softer resin for the outer layer in the portion that contacts the lacrimal passage.
When the laminated structure has three layers, polyurethane is used for the outermost layer, adhesive polyethylene is used for the intermediate layer, and high-rigidity polyethylene is used for the innermost layer. Therefore, there is an advantage that the pushability can be obtained and the safety when operated in the lacrimal passage is excellent.
Even in the case of four or more layers, it is preferable to use polyurethane for the outermost layer and highly rigid polyethylene for the innermost layer.
Also, each layer is welded over the entire long axis direction of the tube-shaped member, so that the continuity of rigidity is maintained, kink hardly occurs, and the force is easily transmitted from the other end side to the one end side when inserting the lacrimal tube. There is an advantage that it is excellent in operability.

When the lacrimal tube is inserted into the lacrimal passage, the lumen of the tubular member serves as a space for accommodating the lacrimal endoscope inserted from the entrance provided at the proximal end of the tubular member, and the lacrimal passage When the tube is placed in the lacrimal passage, it becomes a flow path for bodily fluids such as tears through an entrance provided at the proximal end of the tubular member.

The opening at one end of the tubular member becomes a part of a flow path for bodily fluids such as tears when the lacrimal tube is indwelled, and of the lacrimal endoscope inserted from the entrance / exit provided at the base end. When the tip is inserted to the vicinity of the opening, the visual field from the lacrimal endoscope is secured through the opening, the tube forms a temporary path, and the mucous membrane is damaged, causing bleeding, etc. Can avoid problems.

The outer diameter of the tube-shaped member may be in a range that can be inserted into the lacrimal passage. For example, if the maximum outer diameter is 0.8 mm or more and 1.7 mm or less, regardless of the difference in nationality and gender. Can handle a wide range of patient lacrimal passages.

The length of the tubular member is not particularly limited as long as it is about the same as a commercially available lacrimal duct tube.

The tubular member has an inlet / outlet communicating with the lumen of the tubular member on the other end side connected to the connecting member. The entrance / exit is not only an entrance / exit for inserting / extracting a lacrimal passage manipulator such as a lacrimal endoscope, but also an entrance / exit of a body fluid such as a tear when the lacrimal tube is placed in the lacrimal passage.
The entrance / exit may be formed on the wall of the tubular member, or may be formed on the proximal end of the tubular member by, for example, obliquely cutting the tubular proximal end toward the connecting member. Also good.
There is no particular limitation on the shape and area of the entrance / exit.

The lacrimal duct tube of the present invention has one feature in that a terminal portion including one end of at least one of the tubular members is formed of a colorless material. By having this feature, the lacrimal endoscope is provided. In a state of being inserted into the lacrimal duct tube, not only from the opening of the tubular member but also from the wall surface of the tubular member, it is possible to observe the external state with a lacrimal endoscope.

The colorless material constituting the end portion includes a transparent material having no color at all, and even if there is a color derived from the constituent resin, it passes through the wall from the lacrimal duct endoscope in the lumen. A material transparent to such an extent that an external state can be observed (for example, translucent blue) is also included.

The total length of the end portion is not particularly limited, and may be in the range of 2 to 10 mm from one end.

In the lacrimal duct tube of the present invention, at least one tubular member is formed with one or more colored portions along the major axis direction of the tubular member around a part of the end portion formed of the colorless material. In addition to being able to observe the external appearance not only from the opening of the tube-like member but also from the wall surface of the tube-like member with a lacrimal endoscope, this feature also has a feature. It becomes possible to confirm the position of the end portion during the procedure.
When the colored portion is further formed to one end of the tubular member, it can be confirmed to the position of one end of the tubular member in the lacrimal passage during the procedure.

The shape of the colored portion is not particularly limited, but it is a series of lines or broken lines, so that the position and state of the distal end portion of the tubular member can be determined by the lacrimal endoscope located in the lumen of the tubular member. Therefore, there is an advantage that it is easy to observe and grasp from, and accurate lacrimal tube insertion can be performed.

Since the colored portion has a width of 1/50 or more and 1/3 or less of the total peripheral length of the end portion, the position and state of the end portion of the tubular member inserted into the lacrimal passage during the procedure It becomes easier to observe and grasp from the lacrimal endoscope in the lumen of the tubular member. The width of the colored part is more preferably 1/20 or more and 1/5 or less.

Further, the position of the colored portion in the tubular member is not particularly limited, and for example, the same side as the position of the entrance and exit in the circumferential direction with reference to the position of the entrance and exit provided on the other end side of the tubular member and If formed on at least one side of the opposite side, the direction of the distal end can also be confirmed from the position of the colored portion that can be observed from the lacrimal endoscope and the position of the entrance / exit of the proximal end.
In particular, when the colored part is formed on the same side as the position of the entrance / exit in the circumferential direction of the tubular member and on the opposite side, even if the terminal part is deformed when the closed part in the lacrimal passage is pierced, the terminal part It is possible to accurately grasp the deformed state and the positional relationship between the opening and the lacrimal endoscope.
Furthermore, changing the width of the plurality of colored portions, for example, the narrow colored portion (thin colored portion) is formed on the same side as the position of the entrance / exit in the circumferential direction of the tubular member, and has a large width. Since the colored portion (wide colored portion) is formed on the opposite side, the direction of the lacrimal tube can be confirmed, and the lacrimal tube is surely inserted into the target place without making a mistake in the direction. Becomes easier. Of course, even when the wide colored portion is formed on the same side as the position of the entrance / exit in the circumferential direction of the tubular member and the narrow colored portion is formed on the opposite side, the same effect as described above is obtained. However, when the wide colored portion is formed on the opposite side to the position of the entrance / exit in the circumferential direction of the tubular member, the orientation of the entrance / exit, and hence the lacrimal duct tube, can be grasped relatively easily, and accurate insertion Easy to use.

There is no particular limitation on the specific color of the colored portion, but since the inside of the nasal cavity is generally red, red and complementary colors or adjacent complementary colors are used in the hue circle so that the eyes can be easily confirmed through the lacrimal endoscope. What is necessary is just to adjust to the color used as a hue relationship, for example, blue, cyan, etc. are mentioned.

Further, the colored portion may be provided at the end portion of at least one tubular member, or the colored portion may be provided at the end portions of the two tubular members. When the colored part is provided in two tube-shaped members, the color of each colored part may be the same or different. In addition, a series of line or broken line colored portions are provided, and when there are a plurality of the lines, the colors of the lines may be the same or different.

In the lacrimal duct tube of the present invention, the hue of one tube-shaped member of the pair of tube-shaped members is a complementary color hue or an adjacent complementary color hue with respect to the hue of the colored portion in the hue ring, The specific position of the tubular member inserted in the dark environment can be easily confirmed.

Specifically, in the tubular member having the colored portion, the entire periphery of the tubular member on the other end side from the colored portion may be colored.
In a procedure using a conventional sheath, it is difficult to insert a sheath into a lacrimal passage that is dark and obstructed with an intricate shape, even if a lacrimal endoscope is used. Could be formed or accidentally inserted into the original temporary road.
However, as described above, if the entire periphery of the tube-shaped member on the other end side is colored from the colored portion, the position of the tube-shaped member previously inserted into the lacrimal passage is inserted into the tube shape later. It can be confirmed from the lacrimal endoscope in the member, and it can be used as a guide to perform accurate insertion. Therefore, the formation of a temporary road can be prevented.

About the color of the tubular member on the other end side from the colored portion, it may be adjusted so that it becomes a complementary hue or an adjacent complementary hue with respect to the hue of the colored portion in the hue ring, for example, yellow, yellow-green, Examples include green.

Among these, from the viewpoint of easy confirmation from the lacrimal endoscope, it is preferable that the color of the colored portion is blue and the color of the colored tubular member on the other end side is yellow.

The colored part may be produced by a method such as line extrusion tube molding using a mold or heat welding a solid tube colored at a desired position of a tubular member, and the production method is particularly limited. Not.

Moreover, the tube-shaped member on the other end side from the colored portion may be colored on at least one tube-shaped member, or may be applied to each of the two tube-shaped members. When the coloring is given to two tube-shaped members, each color may be the same or different.

In addition, when the above-mentioned coloring is given to two tube-shaped members, when confirming the position of the tube-shaped member previously inserted in the lacrimal passage through the lacrimal endoscope from the inside of the tube-shaped member inserted later The color of the tubular member previously placed with respect to the inner surface of the nasal cavity is conspicuous. That is, the tubular member can be confirmed more clearly in the dark lacrimal passage, and the positional accuracy of the tubular member to be placed later can be increased. Furthermore, depending on the type of color applied to the two tube-shaped members, the tube-shaped member may be used even if there is no colored portion at the end. Examples of such colors include yellow, yellowish green, and green.

In addition, the colored part is eliminated by making the end part not transparent and colorless, but by using a transparent material (for example, translucent blue) that allows the external appearance to be observed from the lacrimal endoscope through the wall of the end part. In some cases. Even in this case, for example, when the two tubular members are colored, the position of the tubular member previously inserted into the lacrimal passage is inserted later from within the tubular member. Since it can be confirmed through the lacrimal endoscope (for example, from the end portion), the tubular member can be more clearly confirmed even in the dark lacrimal passage, and the positional accuracy of the tubular member to be placed later can be improved.

In the lacrimal duct tube of the present invention, the tubular member and the connecting member are connected. The connecting member is for connecting the other ends of the two tubular members and may have a diameter smaller than that of the tubular member, and the diameter is not particularly limited.
The resin constituting the connecting member may be a flexible resin, and examples thereof include a resin composition containing silicone, polyamide elastomer, polyurethane, isobutylene copolymer, and alloys thereof. However, it is not limited to these.

The length of the connecting member is not particularly limited as long as it is about the same as a commercially available lacrimal duct tube.

The way of connecting the tubular member and the connecting member is not particularly limited. For example, the end of the other end side of the tubular member and the end of the connecting member may be in contact with each other, or from the viewpoint of increasing the connecting surface and increasing the strength of the connecting portion, You may be connected by the side surface of the base end part of a member, and the side surface of the said connection member.

In addition, the lacrimal tube of the present invention may be provided with a hydrophilic coating on the surface of the tubular member or the connecting member from the viewpoint of excellent insertion into the lacrimal passage and operability in the lacrimal passage. .

The hydrophilic coating used for the hydrophilic coating portion expresses lubricity when it comes into contact with blood or tears, reduces resistance when the lacrimal passage is inserted, and realizes suitable operability in the lacrimal passage Is. The type of hydrophilic coating is not particularly limited, and hydrophilic polymers such as poly (2-hydroxyethyl methacrylate), polyacrylamide, polyvinyl pyrrolidone, polyalkylene glycol, monomethoxy polyalkylene glycol, or blends thereof are preferably used. Is done.

The lacrimal endoscope used in the present invention is not particularly limited as long as it can be used for treatment of lacrimal passage obstruction.
In addition, when inserting the lacrimal tube of the present invention into the lacrimal passage, a lacrimal tube operating tool other than the lacrimal endoscope can be used. As such a lacrimal duct tube operating tool, for example, an operating rod such as a bougie is cited.

Hereinafter, the lacrimal duct tube according to the present invention will be described based on a plurality of embodiments shown in the drawings, but the present invention is not limited to these embodiments.

4 (a), 4 (b), and 4 (c) show an example of the appearance of the lacrimal duct tube 1 of the present invention. 4A is a perspective view of the lacrimal tube 1, FIG. 4B is a side view of the lacrimal tube 1, and FIG. 4C is a top view of the lacrimal tube 1.

The lacrimal duct tube 1 is a lacrimal duct tube including a pair of tubular members 2 and a connecting member 3 that connects the ends of the tubular members 2.
Each of the tubular members 2 has an opening 5 at one end (tip) 4, and the opening 5 communicates with the lumen 6. The pair of tubular members 2 are both connected to the connecting member 3 on the other end side 7.

As shown in FIG. 4C, the tubular member 2 is composed of a distal end portion 8, a main body 9, and a proximal end portion 10 from one end 4 to the other end 7. have.

In the lacrimal duct tube 1, at least one end portion 8 including the one end 4 of the tubular member 2 is formed of a colorless material.

The total length of the end portion 8 is not particularly limited, and may be in the range of 2 to 10 mm from the one end 4.

Further, in the lacrimal duct tube of the present invention, a colored portion (line) 12 is formed along the long axis direction of the tubular member around a part of the end portion 8 formed of the colorless material. In FIG. 4 (a), the colored portion 12 is provided on the opposite side of the entrance / exit 11 with respect to the circumferential direction of the tubular member, and therefore is in a position that cannot be seen in the side view of FIG. 4 (b).

The colored portion 12 may be formed up to one end 4 of the tubular member 2 as shown in FIGS. 4A and 4C, or may be shorter.

The shape of the colored portion 12 may be a series of lines as shown in FIGS. 4 (a) and 4 (c), or may be a broken line as shown in FIGS. 5 (a) and 5 (b). FIG. 5B is an enlarged view of the vicinity of the end portion 8 of the tubular member 2 of FIG.

The width of the colored portion 12 may be a width of 1/50 or more and 1/3 or less with respect to the entire peripheral length of the end portion 8. For example, as shown in FIGS. 6 (a) and 6 (b), even if the width is 1/3 of the entire peripheral length of the end portion 8, the inside of the lacrimal passage through the transparent wall portion other than the colored portion 12 is used. Confirmation is possible. In addition, FIG.6 (b) is an enlarged view of the terminal part 8 vicinity of the tubular member 2 of Fig.6 (a).

The colored portion 12 may be formed on the same side as the position of the entrance / exit 11 in the circumferential direction of the tubular member 2 and on at least one side opposite to the side. For example, the position of the narrowest portion (the other end 7) of the tapered shape of the base end portion 10 which is eccentric with respect to the center of the base end portion 10 of the tubular member 2 or the main body 9 is the position of the entrance / exit 11. It may be on the opposite side of the position.
Specifically, in the lacrimal duct tube 1 shown in FIGS. 4A and 4C, the colored portion 12 is formed on the side opposite to the position of the entrance / exit 11 in the circumferential direction of the tubular member 2. Further, in FIGS. 4A and 4C, when the position of the colored portion 12 is changed to the opposite side with respect to the end portion 8 in the cross-sectional direction orthogonal to the major axis direction, the colored portion is not shown. 12 is formed on the same side as the position of the entrance / exit 11 in the circumferential direction of the tubular member 2.
Moreover, as shown to Fig.7 (a), (b), the two

colored parts

12a and 12b may be formed in the same side as the position of the entrance / exit 11 in the circumferential direction of the tubular member 2, and an opposite side. In this case, for example, as shown in FIG. 8, the width of the colored portion 12a on the same side as the position of the entrance / exit 11 is preferably different from the width of the colored portion 12b on the side opposite to the position of the entrance / exit 11 ( However, the present invention is not limited to this, and the arrangement of the

colored portions

12a and 12b having different widths may be reversed, or the

colored portions

12a and 12b having the same width may be formed. Even if it becomes difficult to grasp | ascertain with the lacrimal duct endoscope from the transparency of a material, since the terminal part 8 deform | transforms greatly at the time of piercing the obstruction | occlusion part and stenosis part in a lacrimal passage when it has become like this, 2 By the

coloring portions

12a and 12b of the book, the deformation state of the end portion 8 can be grasped three-dimensionally, the position of the opening 5 can be grasped by the lacrimal endoscope, and the tip position of the lacrimal endoscope can be grasped. Further, the orientation of the lacrimal tube can also be grasped from the positional relationship between the

colored portions

12a and 12b having different widths and the entrance / exit 11. These allow accurate lacrimal tube insertion.

Further, in one tubular member 2, another colored portion 13 is provided around the entire circumference of the tubular member 2 on the other end side from the colored portion 12.
The colored portion 13 may be formed at least on the main body 9 of the tubular member 2 as shown in FIGS. 4 (a) to 4 (c), but may also be formed on the base end portion 10. .
The colored portion 13 may be on one side of the tubular member 2. Moreover, you may give the colored part 13 to both the tubular members 2 like the lacrimal duct tube 1 shown to Fig.9 (a), (c). The lacrimal tube 1 shown in FIGS. 9 (a) to 9 (c) has the same configuration as the lacrimal tube 1 shown in FIGS. 4 (a) to 4 (c) except that the two colored portions 13 are provided. Is the same.

The hue of the colored portion 13 is a complementary hue or an adjacent complementary hue with respect to the hue of the colored portion 12 in a hue circle.
Especially, since the color of the colored portion 13 is yellow and the color of the colored portion 12 is blue, the position of the tubular member 2 can be easily confirmed in the dark lacrimal passage.
Moreover, when the colored part 13 is given to the two tubular members 2 like the lacrimal duct tube 1 shown to FIG. 9 (a), (c), the color of one colored part 13 is changed. Yellow, yellow-green, or green may be used, and the color of the other colored portion 13 may be the same as or different from the color described above.

In the lacrimal duct tube 1 of the present invention, the entrance / exit 11 is provided at the end on the other end side of the tubular member as shown in FIGS. 4 (a), 5 (a), and 6 (a). In addition, you may provide in the wall part of the tubular member 2. FIG. For example, you may provide a hole in the arbitrary wall part of the main body 9 of the tubular member 2 of FIG.4 (c) (not shown). The shape of the hole is not particularly limited, but an elliptical shape is preferable.
Moreover, in the lacrimal duct tube 1 shown to Fig.5 (a), FIG.6 (a), and Fig.7 (a), all have given the colored part 13 to one tubular member 2, but FIG. ), Colored portions 13 may be applied to both tubular members 2. Further, when the colored portions 13 are respectively provided on the two tubular members 2, the color of one colored portion 13 is set to yellow, yellowish green, or green, and the color of the other colored portion 13 is set to the above-described color. The color may be the same color or a different color.

Example 1
A lacrimal tube having a laminated structure in which the end portion of the tubular member has a single layer and the main body has a four-layer structure was produced as follows.
First, a base end tube made of polyurethane having the same diameter is brought into contact with the other end of a tube having a single layer and a main body having a four-layer structure. The rod side surfaces were connected and adjusted so that the position of the tip of the rod would be closer to one end side than the abutting surface, and the connection locations of each part were thermally welded at once.
Next, a pair of tubular members and connections having the appearance shown in FIGS. 4 (a) to 4 (c) are formed by obliquely cutting the vicinity of one end side to the other end side of the base end portion to form an entrance / exit. A lacrimal tube having a member was prepared.

The structure of each member used is as follows.
(Tube-shaped member)
(1) Terminal part Low-density polyethylene terminal part length: approx. 4mm, diameter: 0.9-1.3mm taper taper
(2) Main body Innermost layer (first layer): made of low-density polyethylene, inner intermediate layer (second layer): made of high-density polyethylene, outer intermediate layer (third layer): made of adhesive low-density polyethylene, outermost layer ( (Fourth layer): Made of polyurethane Lumen diameter: 0.96 mm

Further, the distal end portion and the main body of the tubular member were in a transparent state so that they could be observed with a lacrimal endoscope from the lumen.

(3) Base end made of polyurethane Inner diameter: 0.96 mm, Length: 5 mm

(Connecting member)
Diameter of polyurethane: 0.7mm
Total length: 23mm

Subsequently, in the two tubular members 2 in the obtained lacrimal tube, one end is placed on the end portion 8 on the same side as the connecting surface of the rod of the connecting member 3 (the side opposite to the position of the entrance / exit 11 of the base end portion 10). A blue colored portion 12 formed to the end was provided. The colored portion 12 was a series of lines, and was adjusted to a width of 1/10 of the total length around the end portion.
Further, in one tubular member, the entire periphery of the main body 9 on the other end side from the colored portion 12 was colored yellow.

(Test Example 1)
Using the lacrimal tube obtained in Example 1, the lacrimal tube was placed in the actual lacrimal passage by the same insertion method as SEP.
First, after inserting the probe of the lacrimal endoscope from the entrance and exit of the base end of the tube-shaped member colored yellow to the vicinity of the opening, it passes through the upper punctum canal from the upper punctum of the actual lacrimal passage. The lacrimal tube was inserted into the lower nasal passage. The inside of the lacrimal passage can be grasped by observing from the opening of the tubular member of the lacrimal tube, and when inserting, the direction of the colored portion of the tubular member can be confirmed without making a mistake in the direction. It was possible to insert it securely into the target place such as a closed part. After confirming that the tip of the lacrimal tube came out from the lower nasal passage, the lacrimal endoscope was removed and the lacrimal tube was placed in the lacrimal passage.
Next, after inserting the probe of the lacrimal endoscope from the entrance / exit of the base end of the transparent tubular member to the vicinity of the opening, and then inserting the probe from the lower punctum of the lacrimal passage through the lower punctum tubule. I went. Even in the dark lacrimal sac and nasolacrimal duct, the position of the previously inserted tubular member could be easily grasped by finding the yellow colored portion. Moreover, the position of the lower nasal passage to be inserted could be easily grasped by confirming the direction of the yellow colored portion.

(Test Example 2)
In the two tubular members 2 in the lacrimal duct obtained in Example 1, on the same side as the position of the entrance / exit 11 of the proximal end 10 and the surface of the distal end 8 on the opposite side, FIG. As shown in (b), blue

colored portions

12a and 12b were provided in a series of shapes each formed up to one end 4. In addition, as shown in FIG. 8, the width of the colored portion 12a on the same side as the entrance / exit 11 was adjusted to be narrower than the width of the colored portion 12b on the side opposite to the entrance / exit 11. The other configuration was the same as in Test Example 1.

In the same manner as in Test Example 1, the lacrimal duct tube was placed in the actual lacrimal passage by using the colored lacrimal duct tube by the same insertion method as SEP. When piercing the occlusion part in the lacrimal passage, the end part was greatly deformed, but the presence of two colored parts in a diagonal relationship in the circumferential direction at the end makes the end part deformed and the opening Insertion was performed while accurately grasping the positional relationship between the head and lacrimal endoscope. Moreover, since the width of the colored portion on the same side as the entrance / exit 11 of the two colored portions is narrowed, the direction of the lacrimal tube can be confirmed, and the direction of the lacrimal tube can be confirmed without mistake in the direction. Could be inserted into.

DESCRIPTION OF SYMBOLS 1 Lacrimal duct tube 2 Tubular member 3 Connection member 4 One end 5 Opening part 6 Lumen 7 Other end 8 Terminal part 9 Main body 10 Base end part 11 Entrance / exit 12 Colored part 13 Colored part on the other end side than the colored part 12 DESCRIPTION OF SYMBOLS 21 Upper punctum 22 Lower punctum 23 Upper lacrimal duct 24 Lower lacrimal duct 25 Total lacrimal duct 26 Lacrimal sac 27 Nasal lacrimal duct 28 Lower nasal passage 29 Lacrimal endoscope 30 Sheath 31 Lacrimal duct 32 Occlusion site 33 Lacrimal duct tube

Claims

A lacrimal duct tube comprising a pair of tubular members having an opening communicating with the lumen at one end, and a connecting member connecting the other ends of these tubular members,
A terminal portion including one end of at least one of the tubular members is formed of a colorless material,
A colored portion along the longitudinal direction of the tubular member is formed on a part of the periphery of the end portion formed of the colorless material,
A lacrimal duct tube, wherein a hue of one tube-shaped member of the pair of tube-shaped members is a complementary color hue or an adjacent complementary color hue with respect to the hue of the colored portion in a hue ring.
The lacrimal duct tube according to claim 1, wherein the colored portion is formed up to the one end.
The lacrimal duct tube according to claim 1 or 2, wherein the colored portion is a series of lines or broken lines.
The lacrimal duct tube according to any one of claims 1 to 3, wherein the colored portion has a width of 1/50 or more and 1/3 or less of the entire peripheral length of the end portion.
The colored portion of the tubular member is formed on at least one side opposite to the same side as the position of the entrance / exit on the other end side of the tubular member in the circumferential direction of the tubular member. The lacrimal duct tube according to any one of 4.
The colored portion is formed on the same side and the opposite side as the position of the entrance / exit in the circumferential direction of the tubular member, and the width of one colored portion is formed different from the width of the other colored portion. 5. The lacrimal duct tube according to 5.
The lacrimal duct tube according to claim 6, wherein the narrow colored portion is formed on the same side as the position of the entrance / exit in the circumferential direction of the tubular member, and the thick colored portion is formed on the opposite side. .
The lacrimal duct tube according to any one of claims 1 to 7, wherein the colored tubular member is yellow and the colored portion is blue.