WO2015079999A1 - 涙道チューブ - Google Patents
涙道チューブ Download PDFInfo
- Publication number
- WO2015079999A1 WO2015079999A1 PCT/JP2014/080669 JP2014080669W WO2015079999A1 WO 2015079999 A1 WO2015079999 A1 WO 2015079999A1 JP 2014080669 W JP2014080669 W JP 2014080669W WO 2015079999 A1 WO2015079999 A1 WO 2015079999A1
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- WO
- WIPO (PCT)
- Prior art keywords
- lacrimal
- tube
- tubular member
- sheath
- duct
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/007—Methods or devices for eye surgery
- A61F9/00772—Apparatus for restoration of tear ducts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
Definitions
- the present invention relates to a lacrimal tube used for lacrimal passage obstruction treatment.
- lacrimal passage obstruction leading to lacrimation 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.
- 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.
- 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.
- the lacrimal passage is composed of 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.
- the operation inside the lacrimal passage must be performed in a groping state, and the bougie is operated blindly, so that the tube is pierced or a hole ( In some cases, the results of treatment were poor.
- a sheath 30 attached to a lacrimal endoscope 29 is connected to an obstruction site 32 in the lower nasal passage 28 of the lacrimal passage 31 from the upper punctum 21 through the upper lacrimal canal 23. After inserting through the obstruction site 32, the lacrimal endoscope 29 is removed.
- the lacrimal tube 33 is connected to the sheath 30, and the sheath 30 is pulled from the side opposite to the side where the lacrimal tube 33 is connected, and the lacrimal passage is inserted into the lacrimal passage 31. The tube 33 is penetrated.
- FIG. 1C the sheath 30 is removed and the lacrimal tube 33 is placed in the lacrimal passage 31.
- 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.
- the lacrimal endoscope 29 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 to place the lacrimal tube 33 in the lacrimal passage 31. In place.
- the above method requires a step of connecting the sheath 30 inserted into the patient's lacrimal passage and the lacrimal tube 33, and the connection between the sheath 30 and the lacrimal tube 33 is released. Can lead to failure.
- various sheaths with different inner diameters and materials are used, and considering the certainty of the procedure and the reduction of complexity, the lacrimal tube can be inserted smoothly into the sheath holes of various materials. It was necessary to satisfy all of the insertability that can be made, the adhesiveness that prevents connection with the sheath during surgery, and the operability that allows smooth operation in the lacrimal passage.
- a lacrimal endoscope inserted into a lacrimal duct tube instead of a sheath, but for example, for lacrimal placement with a flexible material having an outer diameter that can be inserted into the lacrimal duct
- a lacrimal passage comprising a main body and a sheath portion made of a flexible cylinder made of a material harder than the lacrimal passage indwelling body and provided at the lower end of the lacrimal passage indwelling main body
- Patent Document 4 is known.
- the lacrimal tract treatment device when used for the sheath-guided endoscopic puncture method, the lacrimal tract treatment device tends to be generally difficult to operate because of its overall length, It was also necessary to separate the lacrimal tract treatment device main body and the sheath after placement in the lacrimal passage.
- an object of the present invention is to use a lacrimal tube that can be suitably used for various lacrimal passage obstruction treatments, specifically, a sheath such as a sheath-guided endoscopic puncture method.
- the lacrimal passage can be firmly fixed to the sheath while being easy to insert into the sheath, and when the lacrimal tube is inserted directly into the lacrimal passage, it has excellent lacrimal passage and operability.
- the present inventors have intensively studied to solve such problems. As a result, focusing on the structure of the surface of the tube-shaped member constituting the lacrimal duct tube, by providing a hydrophilic coating portion and an uncoated portion where the hydrophilic coating is not formed, sheath guided endoscope puncture This method is excellent in insertability into the sheath, but can be firmly fixed to the sheath, and when the lacrimal tube is directly inserted into the lacrimal passage, it has excellent permeability and operability inside the lacrimal passage As a result, the present invention has been completed.
- the gist of the present invention is as follows.
- a pair of tube-shaped members having an opening communicating with the lumen at one end and having a hole in the wall for guiding the lacrimal tube operation tool to the lumen;
- a connecting member that connects the other ends of the tubular member;
- the lumen near the opening includes an engaging portion that engages with the distal end of the lacrimal tube operation tool,
- the engaging portion is a portion formed of a resin that is a part of the material of the tube-shaped member or a portion formed of a material different from the resin, and
- tubular member of the uncoated portion and the tubular member of the hydrophilic coated portion located on the other end side with respect to the uncoated portion are both tapered.
- the lacrimal duct tube according to [10] wherein the total length of the hydrophilic coating portion is longer than the total length of the uncoated portion.
- a pair of tubular members having an opening communicating with the lumen at one end and having a hole in the wall for guiding the lacrimal tube operation tool to the lumen are used. Therefore, it is possible to insert the lacrimal tube directly into the lacrimal passage as well as to insert it into the sheath as in the sheath guided endoscopic puncture method, and in particular, one end is a blind end.
- the tip of the endoscope inserted through the hole to the vicinity of the opening the visual field from the lacrimal endoscope can be secured through the opening, and the tube is passed through.
- the lacrimal duct tube can be firmly fixed when inserted into the sheath.
- 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. 2 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 tube placed in the lacrimal passage, A pair of tube-shaped members having an opening communicating with the lumen at one end and having a hole in the wall for guiding the lacrimal tube operation tool to the lumen; A connecting member that connects the other ends of the tubular member; A lacrimal tube containing, A surface of the tubular member includes a hydrophilic coating portion and an uncoated portion where the hydrophilic coating is not formed.
- the resin constituting the tubular member is not particularly limited, and examples thereof include, but are not limited to, a resin composition containing silicone, polyamide elastomer, polyurethane, isobutylene copolymer, and alloys thereof. .
- the alloy is not particularly limited.
- 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.
- 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.
- SIBS styrene-isobutylene-styrene block copolymer
- thermoplastic polyurethane resin (B) (hereinafter sometimes referred to as TPU), “Milactolan E385PNAT” manufactured by Nippon Miractran, which is an ether-based aromatic cyclic polyurethane, “Tecotan TT1074A” manufactured by Lubrizol, or ether-based alicyclic “Tecoflex EG100A”, “Tecoflex EG85A” manufactured by Lubrizol, which is a polyurethane, or “Calbutton PC3575A” manufactured by Lubrizol, which is a polycarbonate-based polyurethane, are preferable.
- an integral tube made of the same resin composition may be used, a tube having a laminated structure in which a plurality of layers of different types of resin are laminated in the thickness direction, or a resin
- a tube having a row structure in which different tubes are connected along the longitudinal direction or a tube having a mixed structure of the laminated structure and the row structure, and there is no particular limitation.
- the lumen of the tubular member serves as a space for accommodating a lacrimal tube operation tool inserted from a hole provided in the wall of the tubular member when the lacrimal tube is inserted into the lacrimal passage, and When the lacrimal duct tube is placed in the lacrimal passage, it becomes a flow path for bodily fluids such as tears through holes and openings provided in the wall of the tubular member.
- the diameter and shape of the lumen may be the same as those of commercially available lacrimal duct tubes, and there is no particular limitation.
- an engaging portion that engages with the distal end of the rod-shaped lacrimal duct tube operating tool can be provided in the lumen near the opening.
- the engaging portion may have an inner diameter smaller than the outer diameter of the distal end of the lacrimal tube operating tool.
- the engaging portion may be formed of a resin that is a part of the material of the tubular member, or may be formed of a material different from the resin.
- the heterogeneous material is not particularly limited, and examples thereof include various hard resins and metals such as stainless steel. Stainless steel is preferred from the viewpoint of preventing corrosion due to contact with body fluids and chemicals.
- Examples of the engaging portion formed of the heterogeneous material include a reinforcing body.
- the shape of the reinforcing body is not particularly limited, and can be disposed in the vicinity of the opening of the tubular member, can secure the visual field of the lacrimal endoscope inserted into the lumen of the tubular member, Any shape that can serve as a mirror stopper may be used, and a substantially ring shape may be used.
- the substantially ring-shaped engaging portion and the tubular member are arranged substantially coaxially, and the engaging portion is open at both ends in the axial direction (which coincides with the axial direction of the tubular member).
- a cylindrical structure may be used. Further, the cylindrical structure is not particularly limited. For example, the width in the direction perpendicular to the axial direction of the engaging portion and the tubular member is shifted from the other end side to the one end side of the tubular member.
- a structure that decreases continuously as the surface moves for example, a structure in which the surface perpendicular to the axial direction is reduced in diameter as it moves from the other end side to the one end side, a so-called tapered shape
- the structure of the inner wall surface of the cylindrical structure is, for example, a bowl-like shape whose diameter is continuously reduced and the diameter is reduced, the structure in which the width of the inner wall surface of the cylindrical structure is continuously reduced, and the inner wall surface
- the structure in which the diameter continuously decreases, the engaging part is arranged coaxially with the tubular member, and the width of the engaging part and the engaging part in the direction perpendicular to the axial direction of the tubular member gradually decreases. It is possible to employ a structure including a stepped portion.
- the arrangement position of the engaging portion is configured to be a predetermined distance from the opening portion in the vicinity of the opening portion of the tubular member.
- the predetermined distance is determined from the viewpoint of serving as a stopper for the lacrimal endoscope and securing the visual field of the lacrimal endoscope.
- the lens position of the distal end portion of the lacrimal endoscope is within 2 mm from the most distal end portion of the opening of the tubular member.
- the lens position of the distal end portion of the lacrimal endoscope is more preferably within 1.5 mm, and further preferably within 1 mm. Therefore, from the viewpoint of securing the visual field of the lacrimal endoscope, the predetermined distance is preferably within 2 mm, more preferably within 1.5 mm, and even more preferably within 1 mm from the opening (the most distal end of the opening). is there.
- the engaging portion can be formed by reducing the inner diameter in the vicinity of the opening on the one end side of the tubular member by using thermal processing on a core material having a predetermined outer diameter. Moreover, you may reduce in diameter by connecting another tubular member to the opening part of the one end side of the tubular member which comprises the lacrimal duct tube of this invention.
- the shape of the engaging portion is not particularly limited as long as the rod-like operation tool can be locked.
- the cross-sectional shape in the thickness direction of the tubular member may be circular, may be a shape in which a part of the circular shape is missing, or may have a shape having at least one portion protruding into the lumen. .
- the inner diameter of the tubular member in the engaging portion may be smaller than the diameter of the rod-like operating tool, but is 0.50 to 0.90 mm from the viewpoint of ensuring a sufficient field of view for the lacrimal endoscope. Is preferable, and 0.65 to 0.86 mm is more preferable.
- the engaging portion As described above, by arranging the engaging portion so as to be a predetermined distance from the opening in the vicinity of the opening at one end of the tubular member, tearing can be achieved while ensuring the visual field of the lacrimal endoscope.
- the insertion of the tubular member into the lacrimal passage using the force relating to the endoscope is smooth. Furthermore, the risk of accidental penetration of the lacrimal endoscope from the opening can be reduced by the engaging portion such as the reinforcing body serving as a stopper. Such an effect can be further improved by adjusting the opening diameter of the opening as described above in addition to the distance from the opening.
- 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 through a hole provided in the wall.
- bodily fluids such as tears when the lacrimal tube is indwelled
- 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 size and shape of the opening may be the same as those of a commercially available lacrimal duct tube, and is not particularly limited, but the visual field range of the lacrimal endoscope is different from the so-called viewing angle of the lacrimal endoscope.
- the diameter of the opening (especially the diameter on the one end side of the opening) can be affected, the diameter of the opening (also referred to as the opening diameter) is determined from the viewpoint of securing the visual field of the lacrimal endoscope. A larger value is preferable.
- the opening diameter is increased, the thickness of the tube-shaped member on one end side is decreased, and it becomes difficult to hold the engaging portion, and the force applied to the lacrimal duct endoscope is used to tear the tube-shaped member. When inserting into the way, there is a possibility that the tip of the lacrimal endoscope passes through the opening.
- the diameter of the opening is preferably 0.5 to 0.8 mm from the viewpoint of holding the engaging portion, preventing penetration of the lacrimal endoscope and securing the visual field of the lacrimal endoscope. 0.65 to 0.75 mm is more preferable.
- the hole provided in the wall of the tubular member becomes a part of a body fluid flow channel such as tears when the lacrimal tube is placed, and the lacrimal tube when the lacrimal tube is inserted into the lacrimal passage It becomes an insertion port for inserting operation tools.
- the size of the hole is not particularly limited as long as the lacrimal tube operation tool can be inserted, but there is an effect that a body fluid such as tears flows between the hole and the opening at one end.
- the shape of the hole portion is preferably a circular shape, an elliptical shape, a square shape, a polygonal shape, or the like, and is not particularly limited. However, the friction with the lacrimal endoscope In some cases, an elliptical shape is preferable in order to reduce the above.
- the outer diameter of the tube-shaped member may be within a range that can be inserted into the lacrimal passage. For example, if the maximum outer diameter is 1.4 mm or more and 1.7 mm or less, regardless of nationality or gender, Can handle a wide range of patient lacrimal passages.
- the lacrimal duct tube of the present invention is characterized in that the surface of the tubular member includes a hydrophilic coating portion and an uncoated portion where the hydrophilic coating is not formed.
- the lacrimal duct tube can be inserted into the sheath and lacrimal duct, and the lacrimal duct tube can be operated easily. Since the lacrimal tube can be firmly fixed when the lacrimal tube is inserted into the sheath, the lacrimal tube of the present invention can be widely applied to various lacrimal passage obstruction treatments currently being performed. .
- 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 position of the hydrophilic coating portion is not particularly limited, but it is preferably provided on one end side from the viewpoint of excellent insertability into the sheath and lacrimal passage, and from the viewpoint of excellent operability in the lacrimal passage. It is preferable to provide on the other end side.
- the uncoated portion refers to the surface portion of the tubular member where the hydrophilic coating portion is not formed.
- the uncoated portion may be provided in a range in which the sheath on one end side of the tubular member can be inserted.
- the inner diameter of the sheath is smaller than the outer diameter of the lacrimal tube when inserted into the sheath.
- a hydrophilic coating portion is formed on the surface of the tubular member (engagement portion surface) at the position where the engagement portion is provided, so that the insertion into the sheath can be performed smoothly.
- by forming an uncoated portion at a position shifted without overlapping with the surface of the engaging portion by inserting the sheath, when the sheath is inserted at the other end than the surface of the engaging portion, The lacrimal tube and the sheath can be firmly fixed.
- a part or all of the uncoated portion is formed between one end of the tubular member and 12 mm or less.
- the uncoated portion is provided at a position 3 mm from one end of the tubular member, one end of the tubular member excessively enters the opening end of the sheath used in the sheath guided endoscopic puncture method. There is an advantage that it can be engaged without being pulled out, and it does not fall out.
- the uncoated portion may be formed so as to extend over the entire region along the periphery of the tubular member, or may be formed so as to extend partially. There is no limitation.
- the outer diameter of the uncoated portion of the tubular member is determined from the viewpoint of ease of fitting and removal from the sheath used in the sheath-guided endoscopic puncture method, and ease of entry into the lacrimal passage via the punctum Therefore, it is preferably 1.0 mm or more and 1.7 mm or less, and more preferably 1.2 mm or more and 1.4 mm or less.
- the shape of the tubular member including the uncoated portion is one of the tubular members from the viewpoint that the tubular member can easily enter the sheath or lacrimal passage.
- the shape is preferably tapered toward the end.
- a taper, a step, or both a taper and a step may be provided on a part or all of the tubular member in the uncoated portion.
- the tube-shaped member of the hydrophilic coating portion adjacent to the uncoated portion is also made of the tube-shaped member from the viewpoint that the tube-shaped member can easily enter the lacrimal passage.
- the shape is preferably tapered toward one end.
- a taper, a step, or both a taper and a step may be provided on a part or all of the tubular member of the hydrophilic coating portion.
- the total length of the hydrophilic coated portion is not yet increased. By making it longer than the total length of the coating part, it becomes excellent in insertability when inserting the lacrimal duct tube directly into the lacrimal passage and operability in the lacrimal passage, and can reduce the burden on the patient. .
- the inner diameter (DI) of the lumen of the sheath and the outer diameter (DT) of the tubular member in the uncoated portion are expressed by the following relational expression (1): 1.00 ⁇ DT / DI ⁇ 1.89 (1)
- the tubular member can easily enter the sheath opening, and if it does, contact between the sheath lumen wall and the surface of the uncoated portion of the tubular member becomes sufficient, and the lacrimal canal tube from the sheath Will not be pushed back.
- the “DT / DI” is larger, the outer diameter of the uncoated portion of the tubular member is larger than the inner diameter of the lumen of the sheath, so that it is difficult to insert the lacrimal tube into the sheath opening.
- the force with which the lacrimal duct tube is pushed out of the sheath becomes stronger, and conversely, the smaller the “DT / DI”, the smaller the outer shape of the tubular member in the uncoated portion relative to the inner diameter of the lumen of the sheath.
- the lacrimal duct tube can be easily inserted into the sheath opening, but a non-contact portion is easily generated between the sheath lumen wall and the surface of the tubular member of the uncoated portion.
- the DT / DI is expressed by the following relational expression (2): 1.20 ⁇ DT / DI ⁇ 1.56 (2)
- the following relational expression (3) is preferably satisfied: 1.26 ⁇ DT / DI ⁇ 1.47 (3) It is more preferable to satisfy.
- the sheath used in the present invention only needs to be composed of a transparent or translucent cylindrical body having flexibility such as silicon, polyurethane, polyethylene, Teflon (registered trademark), and can be used for treatment of lacrimal passage obstruction. Anything is acceptable.
- the inner diameter of the sheath is preferably in the range of 0.9 to 1.0 mm from the relationship with the outer diameter of the tubular member to be inserted.
- 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.
- the resin constituting the connecting member it may be constituted by a flexible resin, for example, silicone, polyamide elastomer, polyurethane, isobutylene copolymer, and a resin composition containing these alloys, etc. It is not limited to these.
- the lacrimal tube operating tool used in the present invention is a device for guiding the lacrimal tube into the lacrimal passage with the lacrimal tube inserted into and placed in the lacrimal passage, and then removing it.
- an operation rod such as a bougie corresponds to this.
- a lacrimal endoscope is used instead of an operating rod such as a bougie.
- Such a lacrimal endoscope also corresponds to a lacrimal duct tube operating tool.
- the operating rod and lacrimal endoscope are not particularly limited as long as they can be used for treatment of lacrimal passage obstruction.
- FIG. 3 shows an example of the appearance of the lacrimal tube 1 of the present invention.
- the lacrimal tube 1 includes a pair of tubular members 5a and 5b each having an opening 2 at one end and a hole 4 communicating with the lumen 3 on a side wall, and a connecting member that connects the other ends of the tubular members 5a and 5b. 6 are included.
- the tubular members 5a and 5b are connected to a connecting member 6 formed narrower than the tubular members 5a and 5b.
- connection between the tubular members 5a and 5b and the connecting member 6 for example, when connecting the outer resin material of the tubular members 5a and 5b and the connecting member 6, the opening 2 of the tubular members 5a and 5b and What is necessary is just to weld to the connection member 6 after reducing the diameter of the opposite end and closing the outer resin material at the outermost end.
- the end of the connection member 6 is inserted into the lumen opposite to the opening 2 of the tubular members 5a and 5b. After that, the tubular members 5a and 5b and the connecting member 6 may be welded by heating according to a conventional method.
- the tubular members 5a and 5b may have a cylindrical shape as shown in FIG. 3, or may have a shape tapered toward one end as shown in FIG.
- the maximum outer diameter of the tubular members 5a and 5b is preferably 1.4 mm or more and 1.7 mm or less.
- FIG. 4 shows a state in which a rod-like lacrimal tube operating tool (operation bar) 7 is inserted from the hole 4 of the lacrimal tube 1 shown in FIG.
- the shape of the hole 4 shown in FIGS. 3 and 4 is an ellipse, but a circular, square, or polygonal hole or notch of a size that can be easily inserted into the rod-shaped lacrimal duct tube operating tool 7. It may be a shape.
- Examples of the rod-shaped lacrimal duct tube operating tool 7 include a lacrimal duct endoscope.
- FIG. 5 (a) is an embodiment of the lacrimal duct tube 1 of the present invention
- FIG. 5 (b) is a schematic view of one end side of the tubular member 5a.
- An uncoated portion 8 is provided on the surface of the tubular member 5a, and the surface of the tubular member 5a other than the uncoated portion 8 is a hydrophilic coating portion 9 to which a hydrophilic coating is applied. Yes.
- the uncoated portion 8 may be formed so as to extend over the entire region along the circumferential direction of the tubular member 5a. As shown to a), you may form so that it may extend over a part so that the surrounding direction of the tubular member 5a may be followed. Moreover, as shown in FIG.6 (b), the some uncoated part 8 may be formed.
- a part or all of the uncoated part 8 is formed between 12 mm or less from one end of the tubular member 5a.
- FIGS. 5 (b), 6 (a), and 6 (b) if the position of X is 12 mm from one end of the tubular member 5a, the uncoated portion 8 in FIG. 5 (b). 6 (a) and 6 (b) show a state in which a part of the uncoated portion 8 is formed between the one end and 12 mm or less.
- the uncoated portion 8 is preferably formed so as to overlap with a position of 3 mm from one end of the tubular member 5a.
- an uncoated portion 8 is provided at a position Y of 3 mm from one end of the tubular member 5a.
- the position of the uncoated portion 8 is, for example, formed so as to extend to one end side of the tubular member 5a from the position Y shown in FIGS. 5B, 6A, and 6B. It may be.
- a taper may be provided as shown in FIGS. 5B, 6A, and 6B, or a step as shown in FIG. May be provided.
- a portion may be tapered toward one end of the tubular member 5a.
- a taper may be provided as shown in FIGS. 5 (b), 6 (a), 6 (b), or in FIGS. 7 (a), 7 (b). Steps may be provided as shown.
- the tubular member 5a of the uncoated portion 8 and the uncoated portion 8 are used.
- the tubular members 5 a of the hydrophilic coating portion 9 located on the other end side are both tapered, it is preferable that the total length of the hydrophilic coating portion 9 is longer than the total length of the uncoated portion 8.
- the length refers to the length in the longitudinal direction Z of the tubular member 5a.
- the total length of the hydrophilic coating portion 9 means the maximum length in the longitudinal direction Z, and when there are a plurality of hydrophilic coating portions 9, the total length thereof.
- the length of the hydrophilic coating portion 9 from one end to the other end is the entire length.
- each length is The total is the total length of the hydrophilic coating portion 9.
- the total length of the uncoated portion 8 is also referred to as the maximum length in the longitudinal direction Z.
- an outer diameter of the tubular member 5a of the said uncoated part 8 1.0 mm or more and 1.7 mm or less are preferable, and 1.2 mm or more and 1.4 mm or less are more preferable.
- the outer diameter of the tubular member 5a of the hydrophilic coating portion 9 is not particularly limited.
- the engaging portions 10a and 10b engaged with the distal end of the lacrimal tube operating tool 7 are inserted into the lumen 3 in the vicinity of the opening 2 of the tubular member 5a. May be provided.
- the engaging portions 10a and 10b are engaged with the distal end of the lacrimal tube operating tool 7 that is accommodated in the lumen 3 from the hole 4 so that the distal end of the lacrimal tube operating tool 7 protrudes from the opening 2. Can be prevented.
- the tubular member 5a may be formed by changing the thickness of the tubular member 5a as in the engaging portion 10a shown in FIG. 8 (a) and narrowing the inner diameter of the lumen 3, or as shown in FIG. 8 (b).
- a substantially ring-shaped engaging portion 10b having a smaller diameter than the cavity 3 may be used.
- the substantially ring-shaped (cup shape with the bottom open) engagement portion 10b may be formed of various hard materials other than the tube-shaped member 5a, or a metal such as stainless steel.
- the shape of the engaging portion 10b is not particularly limited.
- the engaging portion 10b includes a taper in which the width in the direction perpendicular to the tube axis direction continuously decreases toward one end side, or a stepped portion that gradually decreases. It may be.
- the surface of the tubular member 5a of the engaging portions 10a and 10b is provided. It is preferable that a hydrophilic coating portion 9 is formed and an uncoated portion 8 is formed without overlapping the surface.
- the lacrimal duct tube 1 of the present invention is also suitably used for a sheath-guided endoscopic puncture method.
- the one end is inserted into the open end of the sheath 30, the uncoated portion 8 and the lumen wall of the sheath 30 are engaged, and the inside of the lacrimal passage is interlocked by the movement of the sheath 30. After reaching the blockage, it is placed in the blockage.
- the sheath 30 is attached to one end of the lacrimal duct tube 1, the inner diameter (DI) of the lumen of the sheath 30 and the outside of the tubular member 5 a of the uncoated portion 8.
- the diameter (DT, not shown) is the following relational expression (1): 1.00 ⁇ DT / DI ⁇ 1.89 (1) If it is the lacrimal duct tube 1 which satisfy
- FIG. Moreover, as said DT / DI, Preferably the following relational expression (2): 1.20 ⁇ DT / DI ⁇ 1.56 (2) More preferably, the following relational expression (3): 1.26 ⁇ DT / DI ⁇ 1.47 (3) By satisfy
- Example 1 Using the tube-shaped members 5a-1 to 5a-3 and the connection member 6 configured as shown in Table 1, the lacrimal duct tube 1 was produced as follows (the tube-shaped member 5b is a tube-shaped member). Since the configuration is the same as that of the member 5a, the description is omitted.) First, the tubular member 5a-1 was welded and connected to each of both ends of the connecting member 6, and then a hydrophilic coating was applied to the surface thereof. Thereafter, an uncoated tube-like member 5a-2 is provided at the tip (free end) of the tube-like member 5a-1, and a tube-like member 5a-3 obtained by applying a hydrophilic coating to the tip of the tube-like member 5a-2.
- each tubular member 5a-3 is cut, the distal end after the cutting is tapered, and the tubular member is placed at a position 2 mm to 5 mm from the distal end of each tubular member 5a-3.
- 5a-2 is arranged (see FIG. 5B).
- a lacrimal duct tube having a tubular member 5a in which an uncoated portion 8 (tubular member 5a-2 portion) was formed over the entire surface was produced.
- the lacrimal duct tube there are six types of lacrimal duct tubes whose outer diameter (DT) at a portion 3 mm from one end of the tubular member 5a is different every 0.1 mm from 0.9 mm to 1.4 m. .
- a hydrophilic coating portion 9 is formed in place of the uncoated portion 8, and the tubular members 5a and 5b having different outer diameters (DT) from 0.1 mm to 1.1 mm every 0.1 mm are formed from one end.
- Three types of lacrimal duct tubes were produced in the same manner as in Example 1 except that they were used.
- the conditions of the tensile tester are as follows. ⁇ Load cell autograph EZ-TEST (Shimadzu Corporation): 20N ⁇ Distance between chucks: 20mm
- the measurement results are shown in Table 2.
- the lacrimal tube with an uncoated portion can be used as a sheath if the outer diameter (DT) at a position 3 mm from the one end of the tubular member is adjusted to 1.0 to 1.4 mm. It can be inserted, the load at the time of insertion is appropriate, it is found that there is also a fixation stability, and it is difficult to pull out from the sheath.
- all of the lacrimal duct tubes of Comparative Example 1 having no uncoated portion on the surface of the tubular member can be inserted into the sheath and are easy to enter because of low insertion load, but are extracted because of low extraction load. Since it was easy, it was highly likely to come off during surgery. Further, when the tube-shaped member has an outer diameter of 1.1 mm, the lacrimal duct tube may naturally protrude from the sheath after the bougie is pulled out.
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Abstract
Description
次いで、図示しないが、涙道内視鏡29に装着した別のシース30を、涙道チューブ33を挿入していない下涙点22から下涙小管24を経て涙道31の下鼻道28にある閉塞部位32に挿入し、この閉塞部位32を貫通した後、涙道内視鏡29を取り外し、このシース30に、前記閉塞部位32を貫通していない涙道チューブ33の端部を接続し、前記涙道チューブ33を接続した側と反対側から前記シース30を引っ張って涙道チューブ33のもう一方の端部を貫通させ、最後に前記シース30を取り外して前記涙道チューブ33を涙道31内に留置する。
しかし、前記涙道治療用具を前記シース誘導内視鏡下穿破法に使用する場合、前記涙道治療用具では、全長が長くなるために全般的に操作がし難くなる傾向があり、また、涙道内に配置後に涙道治療用具本体とシース部を分離する必要もあった。
前記チューブ状部材の他方端同士をつなげる接続部材と、
を含む涙道チューブであって、
前記チューブ状部材の表面に、親水性コーティング部分と前記親水性コーティングが形成されていない未コーティング部分とが含まれる涙道チューブ。
前記未コーティング部分が、前記係合部を設けた位置の前記チューブ状部材の表面と重ならずにずれて形成されている前記〔1〕に記載の涙道チューブ。
その先細りした前記チューブ状部材において、前記親水性コーティング部分の全長が、前記未コーティング部分の全長に比べて長い前記〔10〕に記載の涙道チューブ。
1.00≦DT/DI≦1.89 (1)
〔16〕前記DIと、前記DTとが、以下の関係式(2)を満たす前記〔15〕に記載の涙道チューブ。
1.20≦DT/DI≦1.56 (2)
そして、前記チューブ状部材の表面に、親水性コーティング部分を設けることで、シースや涙道への挿入性や涙道内での操作性に優れるものとし、さらに前記チューブ状部材の表面に未コーティング部分を設けることで涙道チューブをシースに挿入した場合にしっかりと固定することができる。
一方端に内腔へ連通する開口部を有するとともに、涙道チューブ操作具を前記内腔に導く孔部を壁部に有する一対のチューブ状部材と、
前記チューブ状部材の他方端同士をつなげる接続部材と、
を含む涙道チューブであって、
前記チューブ状部材の表面に、親水性コーティング部分と前記親水性コーティングが形成されていない未コーティング部分とを含む。
本発明では、上記アロイとしては特に限定はないが、例えば、ポリウレタンとイソブチレン系共重合体のアロイを用いる場合、前記イソブチレン系ブロック共重合体(A)と、熱可塑性ポリウレタン系樹脂(B)との割合を調整することで、チューブの硬さを調整できる。熱可塑性ポリウレタン系樹脂(B)の割合を大きく設定するほど、チューブの硬度を大きくすることができる。尚、抗血栓性、表面滑り性、柔軟性の観点から考えると、イソブチレン系ブロック共重合体(A)が1重量%以上含まれていることが好ましい(即ち、イソブチレン系ブロック共重合体(A)と熱可塑性ポリウレタン系樹脂(B)の割合が、重量比で(A)/(B)=1/99~99/1)。中でも、耐摩耗性の観点から考えると、イソブチレン系ブロック共重合体(A)と熱可塑性ポリウレタン系樹脂(B)の割合が、重量比で(A)/(B)=1/99~70/30であることが好ましい。特に、圧縮応力の観点から考えると、イソブチレン系ブロック共重合体(A)と熱可塑性ポリウレタン系樹脂(B)の割合が、重量比で(A)/(B)=1/99~50/50であることが好ましい。本発明に用いられる一体のチューブ用の樹脂組成物はイソブチレン系ブロック共重合体(A)と熱可塑性ポリウレタン系樹脂(B)のみからなるものでもよいが他の成分を混合してもよい。
前記内腔の直径及び形状については、市販の涙道チューブと同様であればよく、特に限定はない。
前記係合部は、前記涙道チューブ操作具の先端外径よりも小径の内径となるようにしていればよい。また、前記係合部は前記チューブ状部材の材料の一部である樹脂で形成されていてもよいし、前記樹脂とは異質の材料で形成されていてもよい。
前記異質の材料で形成された係合部としては、例えば、補強体が挙げられる。前記補強体の形状は特に限定はなく、チューブ状部材の開口部の近傍に配置可能であり、チューブ状部材の内腔に挿入された涙道内視鏡の視野の確保が可能で、涙道内視鏡のストッパーの役目を果たすことが可能な形状であればよく、略リング形状などが挙げられる。
具体的には、略リング形状の係合部とチューブ状部材が概ね同軸状に配されたうえで、係合部はその軸方向(チューブ状部材の軸方向と一致する)の両端が開口する筒状構造とすればよい。また、前記筒状構造としては、特に限定はないが、例えば、係合部とチューブ状部材の軸方向に対して垂直方向にある幅が、チューブ状部材の他方端側から一方端側に移行するにつれて連続的に減少するような構造、例えば、前記軸方向と垂直方向にある面が他方端側から一方端側に移行するにつれて縮径されるような構造、いわゆるテーパー形状であるもの、前記筒状構造の内壁面の構造が、例えばお椀状のように傾斜角度が連続的に変化して縮径したもの、前記筒状構造の内壁面の幅が連続的に減少する構造や、内壁面が連続的に縮径する構造、係合部がチューブ状部材と同軸状に配され、係合部とチューブ状部材の軸方向に対して垂直方向の係合部の幅が、段階的に減少する段差部を備えるような構造を採用することができる。
また、前記係合部の形状としては、棒状操作具を係止できればよく特に限定はない。例えば、チューブ状部材の肉厚方向の断面形状が円形であってもよいし、円形のうちの一部が欠けた形状でもよいし、内腔に突き出た部分を少なくとも1つ以上有する形状でもよい。
また、涙道内視鏡を用いている間は、チューブ状部材が通されている経路を知ることが確実であり、チューブが仮道を作ったりして、粘膜等を傷つけ出血を引き起こす等の問題を避けることができる。
前記開口部の大きさ及び形状については、市販の涙道チューブと同様であればよく、特に限定はないが、涙道内視鏡の視野範囲は、涙道内視鏡のいわゆる視野角を別にすれば、開口部の径(特に開口部の一方端側の径)の大きさによっても影響を受け得るため、開口部の径(開口径とも称する)は、涙道内視鏡の視野確保の観点からは、大きいほど好ましい。一方、開口径を大きくすると、一方端側のチューブ状部材の肉厚が小さくなり、前記係合部を保持することが困難となり、涙道内視鏡にかかる力を利用してチューブ状部材を涙道へ挿入する際に、開口部から涙道内視鏡の先端が突き抜ける可能性がある。そのため、係合部を保持し、涙道内視鏡の突き抜け防止と涙道内視鏡の視野確保の観点から、開口部の径(開口径)は、0.5~0.8mmであるのが好ましく、0.65~0.75mmがより好ましい。
前記孔部の大きさとしては、前記涙道チューブ操作具が挿入できればよく特に限定はないが、前記孔部と一方端の開口部との間を涙などの体液が流れる効果があるため、ある程度の大きさの孔であることが好ましく、また孔部の形状としては、円状、楕円形状、四角状、多角形状などの形状にすればよく特に限定はないが、涙道内視鏡との摩擦を低減するために楕円形状が好ましい場合がある。
なお、親水性コーティング部分の位置については、特に限定はないが、シースや涙道への挿入性に優れる観点からは一方端側に設けることが好ましく、涙道内での操作性に優れる観点からは他方端側に設けることが好ましい。
中でも前記未コーティング部分が前記チューブ状部材の一方端から3mmの位置に設けられていると、シース誘導内視鏡下穿破法において用いるシースの開口端にチューブ状部材の一方端が過度に侵入することなく係合でき、しかも抜け落ちないという利点がある。
この先細る形状としては、例えば、未コーティング部分のチューブ状部材の一部又は全部にテーパーや段又はテーパーおよび段の両方が設けられていればよい。
この先細る形状としては、例えば、親水性コーティング部分のチューブ状部材の一部又は全部にテーパーや段又はテーパーおよび段の両方が設けられていればよい。
1.00≦DT/DI≦1.89 (1)
を満たすことで、チューブ状部材がシース開口部に入り易く、かつ入ってしまうとシース内腔壁と未コーティング部分のチューブ状部材の表面との間での接触が十分となり、シースから涙道チューブが押し戻されることもなくなる。
なお、前記「DT/DI」が大きいほど、シースの内腔の内径に対して未コーティング部分のチューブ状部材の外径の方が大きくなるためシース開口部への涙道チューブの挿入がし難くなり、またシースから涙道チューブが押し出される力が強くなり、反対に、前記「DT/DI」が小さいほどシースの内腔の内径に対して未コーティング部分のチューブ状部材の外形が小さくなるためシース開口部への涙道チューブの挿入がし易くなるが、シース内腔壁と未コーティング部分のチューブ状部材表面との間で未接触部分が生じ易くなる。
また、前記DT/DIは、以下の関係式(2):
1.20≦DT/DI≦1.56 (2)
を満たすことが好ましく、以下の関係式(3):
1.26≦DT/DI≦1.47 (3)
を満たすことがより好ましい。
なお、シース内径については、挿入するチューブ状部材の外径との関係から、0.9~1.0mmの範囲であることが好ましい。
前記操作棒及び涙道内視鏡としては、涙道閉塞治療に使用できるものであればよく、特に限定はない。
本実施形態の涙道チューブ1では、チューブ状部材5a、5bは、該チューブ状部材5a、5bよりも細く形成された接続部材6と接続されている。
チューブ状部材5a、5bと接続部材6との接続については、例えば、チューブ状部材5a、5bの外側樹脂材料と接続部材6とを接続する場合は、チューブ状部材5a、5bの開口部2と反対側の端部を縮径し、その外側樹脂材料を最端部に配置するように閉じてから接続部材6と溶着すればよい。また、チューブ状部材5a、5bの内側樹脂材料と接続部材6とを接続する場合は、チューブ状部材5a、5bの開口部2とは反対側の内腔内に接続部材6の端部を挿入したのち、常法に従って、加熱してチューブ状部材5a、5bと接続部材6とを溶着すればよい。
前記棒状の涙道チューブ操作具7としては、涙道内視鏡も含まれる。
親水性コーティング部分9の全長とは長手方向Zで最大の長さをいい、親水性コーティング部分9が複数ある場合にはその合計の長さをいう。例えば、図6(a)に示すように未コーティング部分8がチューブ状部材5aの全周囲に設けられていない場合、一方端から他方端までの親水性コーティング部分9の長さが全長となる。また、図7(a)に示すように未コーティング部分8がチューブ状部材5aの全周囲に設けられていて、親水性コーティング部分9が2つにわかれている場合には、それぞれの長さの合計が親水性コーティング部分9の全長となる。
同様に、未コーティング部分8の全長も同様に、長手方向Zで最大の長さという。
前記親水性コーティング部分9のチューブ状部材5aの外径については、特に限定はない。
係合部10a、10bは、孔部4から内腔3内に収まった涙道チューブ操作具7の先端と係わり合うことで、前記涙道チューブ操作具7の先端が開口部2から突き出ることを防ぐことができる。
前記係合部10bの形状としては特に限定はないが、例えば、前記チューブ軸方向に垂直方向の幅が、一方端側に向かって連続的に減少するテーパーや段階的に減少する段差部を備えていてもよい。
この場合、図9に示すように、涙道チューブ1の一方端にシース30を装着する際に、シース30の内腔の内径(DI)と、前記未コーティング部分8のチューブ状部材5aの外径(DT、図示せず)が以下の関係式(1):
1.00≦DT/DI≦1.89 (1)
を満たす涙道チューブ1であれば、シース30へ挿入性及び固着性に優れたものとなる。また、前記DT/DIとしては、好ましくは以下の関係式(2):
1.20≦DT/DI≦1.56 (2)
を満たすこと、より好ましくは以下の関係式(3):
1.26≦DT/DI≦1.47 (3)
を満たすことで、シース30への挿入性及び固着性がより優れたものとなる。
表1に示すような構成のチューブ状部材5a-1~5a-3と接続部材6とを用い、以下のようにして涙道チューブ1を作製した(なお、チューブ部状部材5bについてはチューブ状部材5aと構成が同じであるため、説明は省略する。)。
まず、接続部材6の両端の各々に、チューブ状部材5a-1を溶着して繋げた後に、その表面に親水性コーティングを施した。その後、このチューブ状部材5a-1の先端(自由端)に、未コーティングのチューブ状部材5a-2、このチューブ状部材5a-2の先端に、親水性コーティングを施したチューブ状部材5a-3を順にセットし溶着させ、テーパー形状とした(テーパー形状については、図5(b)の未コーティング部分8と、その未コーティング部分8から一方端側に隣接する親水性コーティング部分9及び他方端側に隣接する親水性コーティング部分9とを参照。なお、表1に各部材の材質、形状等を記載する)。
次いで、このように、一対のチューブ状部材5a-1~5a-3と接続部材6とを一連状にした後、各チューブ状部材5a-3の自由端から30mmの位置に孔部4を形成し、さらにチューブ状部材5a-3部分の内腔の直径を縮径して係合部を形成した。
次いで、各チューブ状部材5a-3の先端(自由端)をカットして、カット後の先端を先細形状にし、かつ各チューブ状部材5a-3の先端から2mm~5mmの位置に、チューブ状部材5a-2を配置させるようにした(図5(b)参照)。
このようにして表面全周に亘って未コーティング部分8(チューブ状部材5a-2部分)を形成したチューブ状部材5aを有する涙道チューブを作製した。
なお、涙道チューブについては、チューブ状部材5aの一方端から3mmの部分の外径(DT)が0.9mm~1.4mまで0.1mm毎に異なる6種類の涙道チューブとなっている。
未コーティング部分8のかわりに親水性コーティング部分9を形成し、一方端から3mmの部分の外径(DT)が0.9mm~1.1mmまで0.1mm毎に異なるチューブ状部材5a、5bを用いた以外は、実施例1と同様にして3種類の涙道チューブを作製した。
18Gシース(サーフロフラッシュ(テルモ製)、コード番号SR-FS1851(長さ51mm、外径1.3mm、内径(DI)0.95mm))を用い、以下の測定方法に従って、シースへの挿入性、固着安定性、引抜荷重を調べた。
1)18Gシース(30)を付け根からカットし、末端部から5mmまでの位置を円周上で半分カットし(図10)、次いで縦にスリットを入れて、ピンセットで把持できる部分を作製した(参考資料:あたらしい眼科29(7);933~940)。
2)1)で作製したシースが全長35mmになるようにカットした。
3)シース及び涙道チューブ内を生理食塩水でフラッシュした。
4)ブジー(LACRIFAST((株)カネカ製、カタログ番号LF-R105)の付属品)を荷重計(デジタルフォースゲージFGC-0.5(日本電産シンポ株式会社社製))に取り付けた後、涙道チューブ内に孔部からブジーを挿入した。
5)涙道チューブの表面を濡らした後、把持部側のシースの開口部から涙道チューブの一方端から3mmまでを挿入した時の荷重を測定した(挿入荷重)。
6)次いで、涙道チューブ内からブジーを引抜いた。
このブジー引き抜き時又はブジー引き抜き後に涙道チューブがシースから飛び出るかどうかを調べた(固着安定性)。
7)涙道チューブとシースをチャックして、引張試験機を使用して、シースから涙道チューブを引抜く時の荷重を測定した(引抜荷重)。
・ロードセルオートグラフ EZ-TEST(株式会社島津製作所):20N
・チャック間距離:20mm
判定 (サンプル数N=3)
(シースへの挿入性)
○ :チューブ先端から3mmの位置までシース内へ入る
× :チューブ先端から3mmの位置までシース内へ入らない
(シースへの挿入荷重)
◎ :平均1.5N以上、最低1.5N以上
○ :平均1.5N以上、最低1.5N以下
△ :平均1.0N以上、最低1.0N以下
× :平均0.5N以上、最低0.5N以下
(シース内での固着安定性)
○ :チューブ状部材を一方端からシース内へ挿入後、ブジー引抜時又はブジー引抜後にチューブ状部材がシースから飛び出る事がない
× :不安定 :チューブ状部材を一方端からシース内へ挿入後、ブジー引抜時又はブジー引抜後にチューブ状部材がシースから飛び出る場合がある
(シースからの引抜荷重)
○ :平均1.0N以上、最低1.0N以上
△ :平均1.0N以上、最低1.0N以下
× :平均1.0N以下、最低1.0N以下
一方、チューブ状部材の表面に未コーティング部分がない比較例1の涙道チューブはいずれもシース内に挿入可能であり、また挿入荷重が低いことから入り易かったものの、引き抜き荷重も低いことから引き抜き易いため、手術中に抜ける可能性が高いものであった。
また、チューブ状部材の外径が1.1mmのものはブジー引き抜き後にシースから涙道チューブが自然に飛び出してしまう場合もあった。
2 開口部
3 内腔
4 孔部
5 チューブ状部材
6 接続部材
7 涙道チューブ操作具
8 未コーティング部分
9 親水性コーティング部分
10 係合部
21 上涙点
22 下涙点
23 上涙小管
24 下涙小管
25 総涙小管
26 涙嚢
27 鼻涙管
28 下鼻道
29 涙道内視鏡
30 シース
31 涙道
32 閉塞部位
33 涙道チューブ
X チューブ状部材5aの一方端から12mmの位置
Y チューブ状部材5aの一方端から3mmの位置
Z チューブ状部材5aの長手方向
DT 未コーティング部分のチューブ状部材の外径
DI シースの内腔の内径
Claims (16)
- 一方端に内腔へ連通する開口部を有するとともに、涙道チューブ操作具を前記内腔に導く孔部を壁部に有する一対のチューブ状部材と、
前記チューブ状部材の他方端同士をつなげる接続部材と、
を含む涙道チューブであって、
前記チューブ状部材の表面に、親水性コーティング部分と前記親水性コーティングが形成されていない未コーティング部分とが含まれる涙道チューブ。 - 前記開口部付近の前記内腔に、前記涙道チューブ操作具の先端に係り合う係合部が含まれており、
前記未コーティング部分が、前記係合部を設けた位置の前記チューブ状部材の表面と重ならずにずれて形成されている請求項1に記載の涙道チューブ。 - 前記係合部が、前記チューブ状部材の材料の一部である樹脂で形成された部分、又は前記樹脂とは異質の材料で形成された部分であり、前記涙道チューブ操作具の先端外径よりも小径の内径を有する請求項2に記載の涙道チューブ。
- 前記未コーティング部分の一部又は全部が、前記チューブ状部材の一方端から12mm以下までの間に形成されている請求項1~3のいずれか1項に記載の涙道チューブ。
- 前記未コーティング部分の前記チューブ状部材の外径が1.0mm以上1.7mm以下である請求項1~4のいずれか1項に記載の涙道チューブ。
- 前記未コーティング部分の前記チューブ状部材の外径が1.2mm以上1.4mm以下である請求項5に記載の涙道チューブ。
- 前記未コーティング部分が、前記チューブ状部材の一方端から3mmの位置に重なるように形成されている請求項1~6のいずれか1項に記載の涙道チューブ。
- 前記未コーティング部分が前記チューブ状部材の周囲方向に沿うように、全域に亘って延びる又は部分的に亘って延びる請求項1~7のいずれか1項に記載の涙道チューブ。
- 前記未コーティング部分の前記チューブ状部材の少なくとも一部が、前記チューブ状部材の前記一方端に向かって先細る請求項1~8のいずれか1項に記載の涙道チューブ。
- 前記未コーティング部分に隣り合う前記親水性コーティング部分の前記チューブ状部材も、前記チューブ状部材の前記一方端に向かって先細る請求項9に記載の涙道チューブ。
- 前記未コーティング部分のチューブ状部材及び前記未コーティング部分よりも前記他方端側に位置する親水性コーティング部分の前記チューブ状部材が共に先細りしており、
その先細りした前記チューブ状部材において、前記親水性コーティング部分の全長が、前記未コーティング部分の全長に比べて長い請求項10に記載の涙道チューブ。 - 前記チューブ状部材の最大外径が1.4mm以上1.7mm以下である請求項1~11のいずれか1項に記載の涙道チューブ。
- 前記孔部が、前記涙道チューブ操作具となる操作棒又は涙道内視鏡の挿入口である請求項1~12のいずれか1項に記載の涙道チューブ。
- 前記一方端がシースの開口端に差しこまれることで、前記未コーティング部分と前記シースの内腔壁とが係り合い、そのシースの移動による連動で涙道内閉塞部に到達し、その閉塞部に留置される請求項1~13のいずれか1項に記載の涙道チューブ。
- 前記シースの内腔の内径(DI)と、前記未コーティング部分の前記チューブ状部材の外径(DT)とが、以下の関係式(1)を満たす請求項14に記載の涙道チューブ。
1.00≦DT/DI≦1.89 (1)
- 前記DIと前記DTとが以下の関係式(2)を満たす請求項15に記載の涙道チューブ。
1.20≦DT/DI≦1.56 (2)
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