JP2006312034A - Nasolacrimal duct tube - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a nasolacrimal duct tube to be used for operation of reforming a lacrimal channel, wherein a bougie can be easily inserted and infection risk during indwelling is suppressed so as to ensure high safety without problems that the tube is detached during operation, mucosa is damaged while inserted and a temporary channel is formed, and the like, by forming a tube end part of an integrated polyurethane tube into a hemispherical shape, thinning a central part, and marking a mark in a circumference of a slit or hole for bougie. <P>SOLUTION: The nasolacrimal duct tube, wherein affection risk during indwelling is suppressed so as to ensure high safety without problems that the tube is detached during operation, mucosa is damaged while inserted and a temporary channel is formed, and the like, is provided for operation of reforming the lacrimal channel using a silicone tube. The penetrating strength of a bougie can be further raised by applying polyurethane with Shore A hardness higher than that of the tube main body, on the inside of a blind end. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  In particular, the present invention relates to a nasolacrimal duct tube for use in surgery to reshape the lacrimal punctum, lacrimal folds, lacrimal sac, and nasolacrimal duct for the treatment of lacrimation.

The human eye and nose are as shown in FIG. 1, and the inside of the eye communicates with the upper punctum 1 and the lower punctum 2 that open up and down on the nose side. The upper tear gavel 3 and the lower tear gavel 4 are connected to the lacrimal sac 6 through the total tear gavel 5. The lacrimal sac 6 communicates with a nasolacrimal duct 7 extending downward, and finally is connected to the nasal cavity. When the punctum, lacrimal fistula, lacrimal sac, nasolacrimal duct, and the like as described above are blocked, tears cannot escape into the nasal cavity, resulting in so-called lacrimation. Thus, as a treatment method for lacrimal passage obstruction including these punctum, lacrimal fistula, lacrimal sac, nasolacrimal duct, etc., a method of inserting and placing a silicone tube or polyurethane tube into the lacrimal passage has been implemented and its usefulness has been confirmed. For example, as a silicone tube, Patent Document 1 proposes a silicone tube having a structure in which an end portion is cut off and sealed, and a method of using the silicone tube. Patent Document 2 proposes a polyurethane tube having a structure in which the indwelling tube is made of polyurethane and the probe tube portion is made of polyolefin, polyamide, or polyurethane, and a method of using the same.
JP-A-6-142129 JP 2001-327525 A

  However, in the silicone tube of Patent Document 1, when the silicone tube is inserted into the punctum and is going to advance in the lacrimal passage, or when the indwelling tube is pulled out, the silicone tube has low strength and may be detached during the procedure. There is a risk of damaging the mucous membrane or the like or forming a temporary tract when the lacrimal passage is inserted. In addition, infection caused by dirt on the surface of the silicone tube during indwelling and granulation formation considered to be caused by it are also problematic. On the other hand, in the polyurethane tube of Patent Document 2, there is a risk that the probe tube portion may be detached because the probe tube portion at the tip of the tube is bonded by adhesion or the like even if it is polyurethane. In addition, in both silicone tubes and polyurethane tubes, small cuts or holes with a length of a few millimeters for inserting the extinguisher (bougie: a dedicated instrument for inserting the nasolacrimal duct into the lacrimal passage) are poorly visible, When inserting a thin tape, it was difficult to see the position clearly, so it took a lot of work to insert it.

In order to solve the above problems, the present invention mainly has the following configuration. That is,
(1) A nasolacrimal duct tube characterized in that the outer surfaces of both ends of the integrally formed tube are substantially hemispherical, and the inner surface has a substantially conical shape with the end side as a vertex.
(2) The nasolacrimal duct tube according to (1), characterized in that the tube has an opening for inserting an extinguisher and has a marking around the opening.
(3) The nasolacrimal duct tube according to (1) or (2), wherein a material having a Shore A hardness higher than the material of the tube body is applied to a part or the entire inner surface of the tube. ,
(4) The nasolacrimal duct tube according to any one of (1) to (3), wherein the tube material is polyurethane rubber,
(5) The nasolacrimal duct tube according to any one of (1) to (4), wherein the thickness of the terminal end is thicker than the tube thickness,
(6) The thickness of both ends of the tube is thicker than the central portion, and the boundary between the both ends and the central portion is a gentle step, which is described in any one of (1) to (5) Nasolacrimal duct tube used for lacrimal passage remodeling,
(7) The nasolacrimal duct tube according to any one of (1) to (6), wherein the material is made of polyurethane and has a marking that does not peel when stretched 1.2 to 10 times. ,
It is.

  Since the nasolacrimal duct tube of the present invention is configured as an integral tube (polyurethane material or the like), the strength is high, and the possibility that the tube is detached during the procedure is small. In addition, because the tip is round and the surface is smooth, there is little risk of damaging the mucous membrane or forming a temporary passage when inserting the lacrimal passage, and the highly safe lacrimal passage that suppresses the risk of moving the tube during infection or infection. A nasolacrimal duct tube for use in remodeling surgery can be provided.

  The nasolacrimal duct tube of the present invention is a tube having a diameter that can be inserted into the lacrimal passage, and the tube body is integrally formed of a resin material. Here, being integrally formed means that each part is not joined by bonding or the like, but is constituted by an integral material.

  Since the nasolacrimal duct tube is required to be flexible, the hardness of the tube body is preferably 70 to 100 in Shore A hardness, and more preferably 72 to 95. Here, the Shore A hardness is a value measured according to JISZ2246 (2000).

  The resin material forming the tube is not particularly limited as long as it does not adversely affect the living body, but polyurethane and silicone are preferable, and polyurethane is more preferable.

  The tube body may have a substantially uniform diameter, but it is preferable that the tube body is composed of a large diameter portion 13 at both ends and a central small diameter portion 9 as shown in FIG.

  The inner diameter of the tube 13 at both ends is not particularly limited as long as it is a diameter capable of inserting a buzzer, but is preferably about 0.2 to 2.0 mm, more preferably about 0.5 to 0.7 mm, for example. It is. Further, the outer diameter of the tube at both ends of the large diameter portion 13 is not particularly limited as long as it can be inserted into the nasolacrimal duct, but is preferably about 0.3 to 3.0 mm, and more preferably, for example, 1.0 to 1. It is about 2 mm.

  Two openings 11 are formed in the large-diameter portions 13 at both ends at a position spaced a predetermined distance from both ends as shown in FIG. This opening 11 is for inserting a bougie into the tube. The position of the opening 11 is preferably a position having a length from the tip of about 20 to 100 mm, more preferably about 25 to 55 mm. The number of openings may be three or more.

  The shape of the opening 11 may be a slit (FIG. 4) with only a cut, or a hole (FIG. 6) such as a circle, an ellipse, an ellipse, a strip, etc. is there. The size of the opening 11 is not particularly limited as long as the opening 11 is large enough to be inserted for inserting a bougie. Specifically, the major axis is preferably about 1 to 2 mm in length, and the slit is preferably about 1 to 2 mm in length. The periphery of the opening 11 is preferably marked (colored) as shown in FIGS. This marking has the effect that the insertion position of the bougie can be confirmed immediately. In particular, when marking is made around the hole (FIG. 7), the visibility is high, which is extremely preferable. As the marking material, dyes, pigments, paints and the like which are commonly used in this field can be used.

  In addition to the periphery of the opening 11, marking is preferably performed at the center of the tube and other positions so as to be a mark for the procedure. As a material used for marking, a material that does not peel even when the tube extends when the tube is inserted into the lacrimal passage or when the placed tube is taken out is preferable. Specifically, it is preferable to have a property that does not peel even when the tube is extended 1.2 to 10 times in an arbitrary direction. More preferably, the marking material does not peel even if it is rubbed in the lacrimal passage. As a specific example, there is a pad ink PAD-SPS black manufactured by Navitas Co., Ltd., and a pad printing ink made by mixing a reinforcing agent and a solvent in a predetermined weight ratio is preferable.

  The central small diameter portion 9 has a role of connecting the large diameter portions at both ends. The inner diameter of the central small diameter portion 9 is preferably about 0.2 to 2.0 mm, and more preferably about 0.3 to 0.5 mm, for example. The outer diameter of the central small diameter portion 9 is preferably about 0.3 to 3.0 mm, and more preferably about 0.6 to 0.8 mm, for example.

  The boundary between the large-diameter portion 13 at both ends and the central thin-diameter portion 9 is preferably a gentle step. By smoothing the step, it is possible to smoothly insert and remove the lacrimal passage. The length of the central small diameter portion 9 is preferably 25 to 35 mm, and more preferably about 27 to 33 mm. Moreover, as for the length of the both ends large diameter part 13, 30-50 mm is respectively preferable.

  The ends 12 at both ends of the tube are preferably round and smooth, and more preferably substantially semi-spherical. Here, the substantially semispherical shape in the present invention includes a round and smooth circular sphere or a part of an elliptic sphere, and it is only necessary that the terminal end has a curved surface. Preferably, when the center point in the cross section at the boundary line 34 (see FIG. 2) between the large-diameter portions 13 at both ends and the end 12 is regarded as the center point of the hemisphere, the radius of an arbitrary position at the end from the center point A shape whose minimum value is 60% or more of the maximum value. The thickness of the end 12 at both ends (thickness in the tube longitudinal direction) is preferably 0.3 to 1.5 mm, and more preferably about 0.4 to 1.0 mm, for example. The thickness 33 of the terminal end is preferably thicker than the thickness of the tube body from the viewpoint of preventing penetration of the bougie. The inside of the terminal end may have a substantially conical shape with the end side as a vertex, and preferably has a gentle substantially conical shape. When guiding the extinguisher to its end in the tube, before guiding it to the tube tip where the penetrating strength against the extinguisher tip is strong, to prevent the extinguisher tip from penetrating from the side of the tube where the penetrating strength is weak, However, since the inside of the terminal end has a substantially conical shape, it is possible to easily guide the extinguisher near the center on the tube cross section side. That is, the substantially conical shape referred to in the present invention is not limited as long as the inner surface has a taper and is tapered toward the end, for example, a shape having a round apex with no corners, an ellipse Includes shapes having a bottom surface. Specifically, the length of the conical portion is preferably about 3 mm. In addition, since the inside of the terminal end has a conical shape, the thickness of the terminal end portion is not uniform, which is considered to lead to strength maintenance and improvement of punch-through strength.

  The total length of the tube is preferably 80 to 120 mm, more preferably about 90 to 110 mm, for example.

  In the nasolacrimal duct tube of the present invention, a material 17 having a Shore A hardness higher than that of the material of the tube body is preferably applied to a part or the entire surface of the inner surface of the tube body. In particular, it is more preferable to use a material having the same Shore A hardness as the material of the tube body. For example, if the tube body is polyurethane with a Shore A hardness of 74, a polyurethane with a Shore A hardness of 93 is applied to the inner surface. By comprising in this way, penetration strength can be improved, without losing the softness | flexibility which a tube main body has. In addition, although it may be the whole inner surface of a tube about the part to apply | coat, only the inner surface of both ends large diameter part 13 may be sufficient, and a part of inner surface of both ends large diameter part 13, especially a part by the side of a termination | terminus It may be.

  Next, the manufacturing method of the nasolacrimal duct tube of the present invention will be described below using polyurethane as an example.

  Polyurethane is extruded, for example, to produce a polyurethane tube having a desired outer diameter and inner diameter. A commercially available tube may be used. When the tube main body is provided with a large-diameter portion at both ends and a small-diameter portion at the center as shown in FIG. And a central small diameter portion can be formed.

  After the tube is cut to the desired length, the end is sealed. The end can be sealed by, for example, bringing it close to a heated metal or the like and melting it. In this case, if the tube is brought into contact with the heating body, it is difficult to round the end, and therefore, the sealing is performed by radiant heat without contact. According to such a melt-sealing method, the outer surface of the terminal end is round and smoothly sealed, and the inside of the terminal end can be formed into a gentle conical shape. Of course, it is needless to say that the method is not limited to the above method as long as the end can be made round and smooth and the inside can be made conical.

  When applying the inner surface of the tube with a material having a Shore A hardness higher than the material of the tube body, before sealing the end, a solution or the like in which the material is dissolved is poured into the tube and dried, Apply material. As a method for injecting the solution into the inside, for example, there are a method of injecting with a syringe or the like, a method of immersing the tube end in the solution and applying a negative pressure to suck up the solution. Although depending on the inner diameter of the tube, the coating thickness can be controlled by the concentration of the material dissolved in the solution. If a two-layer tube using a material having a higher Shore hardness than the material of the tube main body serving as the outer layer is used as the inner layer of the tube, it is not necessary to apply it to the inside of the tube main body.

  The opening is provided with a slit or hole of a desired size at a desired position by cutting, punching, melting or the like with a cutter. Thereafter, marking is performed around the opening.

  The nasolacrimal duct tube of the present invention thus manufactured has a high strength because it is made of integral polyurethane. In addition, since the end is round and the surface is smooth, there is little risk of damaging the mucous membrane or the like or forming a temporary path when inserting the lacrimal passage. Furthermore, since the inside of the terminal end has a gentle conical shape, it is possible to reduce the possibility that, when the extinguisher (bougie) is inserted, the extremity (bougie) tip is guided to the tube center side and breaks through the side surface. Moreover, since the penetration strength is strengthened by the polyurethane having a high Shore hardness and the termination thickness being thick, the possibility of breaking through the tip can be reduced.

  Hereinafter, the present invention will be described in detail by way of examples, but the present invention is not limited thereto.

[Example 1]
A polyurethane tube with an outer diameter of 1.0 mm and an inner diameter of 0.6 mm (Tecotan TT-1074A, manufactured by Thermedix Corp., Shore A hardness 74) was prepared by extrusion molding. The portion other than the portion to be thinned (30 mm in length) was covered and soaked in hot water for a certain period of time, and then cooled to form a small diameter portion.

  After cutting both ends so that the total length becomes 97 mm centering on the small diameter part 30 mm, two holes for the extinguisher were opened. The position of the hole was 28 mm from each end face to the inside of the ellipse, and the shape was an ellipse having a width of 0.3 mm and a total length of 2 mm. Thereafter, the end face of the tube was brought closer without being brought into contact with a hot plate at 220 ° C., and the end was sealed. The end became a smooth semi-spherical shape and was held over a hot plate until the end thickness was about 1 mm. As a result of processing the other tube end face in the same manner, an integrated nasolacrimal tube having a total length of 90 mm could be produced. When the perimeter of the hole for the son was marked with an oil-based magic, the position of the hole could be clearly confirmed by visual observation, and the insertion of the son could be done very easily.

[Example 2]
After the preparation up to the stage before the end was processed in the same manner as in Example 1, a solution of 10% by weight of polyurethane (Tecoflex EG93A, manufactured by Thermedix, Shore A hardness 93) dissolved in tetrahydrofuran was sucked up by negative pressure from both ends of the tube. Then, it was dried and thinly applied to the inner surface. Thereafter, both ends were formed in a substantially semispherical shape in the same manner as in Example 1. The effect of applying polyurethane with high Shore A hardness on the inner surface was measured using the measuring jigs shown in FIGS. 8 and 9, and the side penetration strength at a position of 3 mm from the end of each was measured with Tensilon Universal Testing Machine (RTA-100, Oriente Measured by a compression test under the conditions of a crosshead speed of 30 mm / min and a distance between chucks of 20 mm, the results shown in Table 1 (average values) were obtained. As a comparative example with a nasolacrimal duct tube made of silicon, a Shirasukon medical tube having an outer diameter of 1.0 mm and an inner diameter of 0.5 mm, manufactured by Kaneka Medix Co., Ltd. was used.

  Compared to Example 1 and Comparative Example, Example 2 has higher side penetration strength and can be said to be safer.

[Example 3]
A nasolacrimal duct tube was produced in the same manner as in Example 2. The effect of applying polyurethane with high Shore A hardness on the inner surface was measured using a measuring jig shown in FIG. 10 and the tip penetration strength was crossed with a Tensilon universal testing machine (RTA-100, manufactured by Orientec Corp.). When measured in a compression test under the conditions of a head speed of 30 mm / min and a distance between chucks of 20 mm, the results shown in Table 2 (average values) were obtained.

Compared to Example 1, Example 3 has higher tip penetration strength and can be said to be safer.

[Example 4]
A nasolacrimal duct tube was produced in the same manner as in Example 1. Depth marks that can determine how much the nasolacrimal duct tube has been inserted into the lacrimal passage from one end of the nasolacrimal duct tube and 1 mm wide x 1 mm long at 5 mm intervals from the end of the tube Now, pad printing ink made by mixing pad ink PAD-SPS black of Navitas Co., Ltd. and reinforcing agent JA940 solvent SGA slow drying at a weight ratio of 10: 2: 3 is used in 8 places. ) Pad printing machine NEAT-70B was used, and the position of the hole for the blank was clearly confirmed by visual observation, so that the blank could be inserted very easily. Also, the depth mark could be printed clearly.

  Next, in order to confirm the peel strength of the marking, the part with the all-round mark and depth mark of the hole of the extinguisher is stretched 10 times in the longitudinal direction of the tube to 10 times, and then the marking is not peeled off. After enlarging and checking, and further rubbing 10 times with a nail, it was enlarged and confirmed that there was no peeling of the marking. In addition, in order to confirm the peeling of the markings after the indwelling period, the nasolacrimal duct tube that was forcibly deteriorated for 36 days in a tap water at 38 ° C. and for 36 days at 60 ° C. and a relative humidity of 80% inside the thermostat As a result of confirming the peeling of the marking by the same method as above, it was confirmed that the marking did not peel.

Schematic showing a human lacrimal passage. The front view which shows the model external appearance of 1 aspect of this invention. AA sectional drawing of FIG. The external view of opening (slit shape) of a nasolacrimal duct tube. The external view of the aspect marked around the slit of FIG. The external view of one mode of opening (oval hole shape) of a nasolacrimal duct tube. The external view of the aspect marked around the hole of FIG. Measuring jig for penetration strength test on the side of the tube. BB sectional drawing of FIG. Measuring jig for penetration strength test at the end of the nasolacrimal tube.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Upper punctum 2 Lower punctum 3 Upper lacrimal tubule 4 Lower lacrimal tubule 5 Total lacrimal tubule 6 Lacrimal sac 7 Nasal lacrimal duct 8 Nostril 9 Central small diameter part 10 Boundary between narrow diameter part and large diameter part 11 Opening marked around 12 Termination 13 Large diameter portion 14 Opening 15 Termination internal conical shape 16 Central thin diameter portion 17 Inner surface coating film 18 Large diameter portion 19 Opening (slit shape)
20 Marking around the slit
21 Opening (Oval hole shape)
22 Marking around the hole
23 Tube holder 24 Tube to be measured 25 Mouth for punch 26 Tube receiving hole 27, 32 Mouth hole 28 Tube to be measured with termination 29 Tube receiving hole with termination 30 Tube receptacle with termination 31 End of measurement tube 33 End thickness 34 Boundary line between large diameter portion 13 at both ends and end 12

Claims (7)

  A nasolacrimal duct tube characterized in that the outer surfaces of both ends of the integrally formed tube have a substantially semispherical shape, and the inner surface has a substantially conical shape with the end side as a vertex.   The nasolacrimal duct tube according to claim 1, wherein the tube has an opening for inserting an extremity and has a marking around the opening.   The nasolacrimal duct tube according to claim 1 or 2, wherein a material having a Shore A hardness higher than that of the tube main body is applied to a part or the entire inner surface of the tube.   The nasolacrimal tube according to any one of claims 1 to 3, wherein the tube is made of polyurethane.   The nasolacrimal duct tube according to any one of claims 1 to 4, wherein a thickness of the terminal end is larger than a thickness of the tube.   The nasolacrimal duct tube according to any one of claims 1 to 5, wherein the thickness of both ends of the tube is thicker than that of the central portion, and the boundary between both ends and the central portion is a gentle step.   The nasolacrimal duct tube according to any one of claims 4 to 6, wherein the nasolacrimal duct tube has a marking that does not peel when stretched 1.2 to 10 times.

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