WO2014115700A1 - 涙道チューブ - Google Patents
涙道チューブ Download PDFInfo
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- WO2014115700A1 WO2014115700A1 PCT/JP2014/051052 JP2014051052W WO2014115700A1 WO 2014115700 A1 WO2014115700 A1 WO 2014115700A1 JP 2014051052 W JP2014051052 W JP 2014051052W WO 2014115700 A1 WO2014115700 A1 WO 2014115700A1
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- shaped
- lacrimal
- arc
- tube
- rod
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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
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 anastomosis (DCR), (iv) lacrimal tube formation , (V) nasolacrimal duct plasty, (vi) lacrimal limb movement.
- DCR lacrimal nasal anastomosis
- lacrimal tube formation for treatment of lacrimal passage obstruction leading to lacrimation, (i) probing with lacrimal passage bougie, (ii) placement of lacrimal duct tube, (iii) lacrimal nasal anastomosis (DCR), (iv) lacrimal tube formation , (V) nasolacrimal duct plasty, (vi) lacrimal limb 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. Because it is easy and minimally invasive, it is often performed as the first treatment.
- v) nasolacrimal duct surgery (vi) lacrimal mobilization is highly effective, but an incision in the face or bone Since the holes are perforated, the degree of invasiveness is relatively high, and it is performed as a last resort.
- the lacrimal tube used in (ii) is placed for probing with the lacrimal passage bougie of (i) to maintain the flow path and reconstruct the tissue.
- the placement of the lacrimal duct tube (ii) is easy, minimally invasive, and highly effective compared to the treatment methods (iii) to (vi) described above, and is widely practiced around the world.
- a lacrimal duct tube see, for example, FIG. 1 of Patent Document 1 in which the central portion of the tube is formed of a thin and soft tube or rod and both sides thereof are formed of a hard and thick tube. Widely used.
- 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 lacrimal endoscope is removed.
- a lacrimal tube is connected to the sheath, and after pulling the sheath from a side opposite to the side where the lacrimal tube is connected to penetrate the lacrimal tube into the lacrimal passage, the sheath is removed and the tear is removed. Place the tube in place.
- a technique in which a lacrimal endoscope is inserted into a lacrimal duct tube instead of a sheath can be considered.
- a lacrimal tube that can be used with the lacrimal endoscope disposed therein include, for example, 1) an opening formed at the end of the lacrimal tube as described in Patent Document 1, and the opening
- a lacrimal tract treatment device (Patent Document 2) characterized by comprising
- This insertion portion is a cut or small hole, and has a structure small enough to allow insertion of a bougie or lacrimal endoscope.
- the insertion portion has such a structure, after inserting one cylindrical portion from one punctum into a predetermined position in the lacrimal passage, the other cylindrical portion is held in the other punctum while maintaining the position.
- it may be difficult to insert the other cylindrical part into the other punctum. This is because a small insertion portion is provided at a location near the central portion of the integral tube, and the flexibility of the bougie or lacrimal endoscope is low.
- a small through hole for insertion of an endoscope camera is provided in a portion of the sheath portion from the lacrimal passage indwelling main body.
- the overall length is long, even after one sheath part is inserted into the lacrimal passage from one punctum, the other sheath part must be inserted into the lacrimal passage from the other punctum. Is possible.
- this lacrimal tract treatment device it is necessary to separate the lacrimal tract treatment device main body from the sheath portion after placement in the lacrimal tract, which makes the procedure complicated.
- the combined width of the lacrimal tube 101 and the rod-shaped operating tool 9b is the same as the width H1 of the tube of the lacrimal tube 101 (see FIG. 11B), but the central member 103 is formed from the opening 102 of the lacrimal tube 101.
- the bar-shaped operation tool 9b and the slightly deformed lacrimal duct tube 101 are overlapped with a width H2 (see FIG. 11C), and the width H2 is larger than the width H1. This makes it difficult to insert the lacrimal tube 101 into the lacrimal passage beyond the opening 102, increasing the burden on the patient.
- the rod-shaped operating tool 9b and the edge 104 on the central member 103 side of the opening 102 of the lacrimal tube 101 are in contact with each other, and the longitudinal direction of the rod-shaped operating tool 9b Movement is hindered, making operation difficult.
- an object of the present invention is to provide a lacrimal tube that can be suitably used for lacrimal passage occlusion treatment using a lacrimal endoscope, specifically, it is necessary to cut the tube after insertion into the lacrimal passage After inserting one tube member into the lacrimal passage from one punctum, the other tear can be held using a stick-like operation tool such as a bougie or lacrimal endoscope while the insertion position is maintained.
- Another object is to provide a lacrimal tube in which the other tube member can be easily inserted into the lacrimal passage.
- At least one of the tubular members constituting the lacrimal duct tube includes a cylindrical portion and an arc-shaped portion having a substantially arc-shaped wall portion in a cross section in a direction orthogonal to the major axis direction of the tubular member, and It has been found that the above problem can be solved by continuously forming the substantially arc-shaped wall portion over a predetermined length, and the present invention has been completed.
- a lacrimal duct tube comprising a pair of tubular members slidable along a rod-shaped operating tool and having a terminal opening at one end, and a central member connecting the other ends of the tubular members.
- At least one of the tubular members extends from the end opening to the central member side, and has a cylindrical portion having a rod-shaped operating tool opening at an end on the central member side, and an end on the central member side of the cylindrical portion
- An arc-shaped portion extending from the portion to the center member side, and having a substantially arc-shaped wall portion in a cross section in a direction orthogonal to the longitudinal direction of the tubular member,
- the lacrimal duct tube in which the substantially arc-shaped wall portion is continuously formed in the arc-shaped portion over a length of 1/3 to 9/10 of the entire length of the tubular member.
- the lacrimal duct tube according to any one of the above [1] to [8], wherein the end of the arcuate portion on the central member side has an end perpendicular to the major axis direction of the arcuate portion.
- the tube-shaped member is composed of a plurality of materials having different Shore hardnesses, and the material constituting the portion that slides with the rod-shaped operating tool has the highest Shore hardness in any one of [1] to [9]
- the lacrimal duct tube according to the above [10] wherein the material constituting the sliding portion with the rod-shaped operation tool is an olefin resin.
- At least one of the tubular members includes a cylindrical portion, so that a rod-like operation tool such as a bougie or a lacrimal endoscope can be reliably held on the lacrimal duct tube. Moreover, by providing the arc-shaped portion, the arc-shaped portion can be bent in a state where the rod-like operation tool is inserted into the cylindrical portion.
- the other tube-like member can be easily inserted into the lacrimal passage from the other punctum using a rod-like operation tool such as a bougie or lacrimal endoscope while maintaining the insertion position. can do.
- a rod-like operation tool such as a bougie or lacrimal endoscope
- the operator grasps the end of the arc-shaped portion on the central member side, and forms a tube shape along the rod-shaped operation tool.
- the member can be slid.
- FIG. 3 is a plan view schematically showing a state in which a rod-like operation tool is attached to the lacrimal duct tube of FIG. 2.
- A It is sectional drawing of the II direction of FIG.
- B It is sectional drawing of the II-II direction of FIG.
- A It is a top view which shows the outline of other embodiment of the lacrimal duct tube concerning this invention.
- B It is sectional drawing of the III-III direction of Fig.6 (a).
- FIG. 6 It is sectional drawing of the IV-IV direction of Fig.6 (a).
- A It is a top view which shows the outline of other embodiment of the lacrimal duct tube concerning this invention.
- B It is sectional drawing of the VV direction of Fig.7 (a).
- A It is a top view which shows the outline of other embodiment of the lacrimal duct tube concerning this invention.
- B It is sectional drawing of the VI-VI direction of Fig.8 (a). It is explanatory drawing which showed the usage method of the lacrimal duct tube which concerns on this invention.
- A It is the perspective view which showed typically the state when inserting the lacrimal duct tube concerning this invention in a lacrimal duct.
- FIG. 11B is a sectional view schematically showing a section of the lacrimal duct tube in the IX-IX direction of FIG. 12C is a cross-sectional view schematically showing a cross section of the lacrimal duct tube in the XX direction of FIG.
- FIG. 1 schematically shows the anatomical structure of the lacrimal passage.
- the lacrimal passage referred to in the present invention is the upper / lower punctum (1/2), upper / lower lacrimal tubule (3/4), total lacrimal tubule (5), lacrimal sac (6) , Lacrimal duct (7), nasal duct (not shown), Hasner's valve (not shown), and lacrimal fluid produced from the lacrimal gland (not shown) is transferred from the ocular surface to the lower nasal passage (8 ) Is a tube (eyeball appendage) that leads to The tube that leads from the upper punctum (1) to the lower nasal passage (8) through the upper lacrimal canal (3) and the total lacrimal canal (5) is called the upper lacrimal passage, and the lower punctum (2) from the lower punctum
- the duct leading to the lower nasal passage (8) through the lacrimal canal (4) and the total tear canal (5) is called the lower lacrimal passage.
- the lacrimal tube which concerns on this invention is used when inserting and
- FIG. 2 is a perspective view showing an outline of an embodiment of the lacrimal tube according to the present invention
- FIG. 3 is a plan view of the embodiment shown in FIG. 2
- FIG. FIG. 5B is a cross-sectional view schematically showing a cross section in the II-II direction of FIG. 3.
- FIG. 4 is a plan view showing a state where the rod-like operating tools 9a and 9b are attached to the embodiment shown in FIG.
- the lacrimal tube 10 shown in the present embodiment includes a pair of tubular members 11a and 11b and a central member 12 that connects the tubular member 11a and the tubular member 11b.
- the pair of tubular members 11a and 11b have the same structure, but may have different structures.
- Terminal openings 13a and 13b are provided at one ends of the pair of tubular members 11a and 11b, respectively. In this way, when the lacrimal endoscope is used as a stick-shaped operation tool, the lacrimal tube is inserted into the lacrimal passage through the terminal opening while confirming the lacrimal passage through the terminal opening. It can be directed to the desired site.
- the pair of tubular members 11a and 11b include cylindrical portions 14a and 14b and arc-shaped portions 15a and 15b.
- the cylindrical portions 14a and 14b have a cylindrical shape, and a rod-shaped operating tool opening 16a provided at the end on the central member 12 side from the end openings 13a and 13b provided at one end thereof. , 16b, and lumen portions 17a, 17b for inserting the rod-like operation tool.
- the cylindrical portions 14a and 14b have a cylindrical shape, but other structures may be employed.
- an engagement portion that engages with the tip of the rod-shaped operating tool may be formed on the inner wall surface near the end opening of the cylindrical portion.
- the engagement portion refers to a portion that forms the minimum width of the lumen portion of the cylindrical portion so as to be smaller than the maximum width of the tip of the rod-like operation tool.
- the lacrimal endoscope can be disposed up to the vicinity of the terminal opening of the tubular member, it is easy to secure a sufficient field of view of the endoscope from the terminal opening. Furthermore, by inserting a rod-like operation tool into the lacrimal duct tube, the lesion site passageability (breakthrough) of the lacrimal duct tube can be improved. In addition, while using the lacrimal endoscope, the path through which the lacrimal tube is passed can be surely known, creating a temporary path, causing damage to the mucous membrane of the lacrimal path and causing bleeding Can be avoided.
- the engaging portion can be formed by reducing the vicinity of the end opening of the cylindrical portion by using thermal processing on a core material having a predetermined outer diameter.
- another tubular member may be connected to the inside of the tip of the cylindrical portion on the end opening side to reduce the diameter.
- 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 a circle, a shape in which a part of the circle is missing, or a shape having at least one portion protruding inward.
- the width of the cylindrical portion in the engaging portion may be smaller than the maximum width of the rod-like operating tool, but is 0.5 to 0.90 mm from the viewpoint of ensuring a sufficient field of view of the lacrimal endoscope. 0.65 to 0.86 mm is more preferable.
- the position of the engaging portion is configured to be a predetermined distance from the end opening in the vicinity of the end opening.
- 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 tip of the lacrimal endoscope is within 2 mm from the most distal end of the tube opening.
- 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.
- the predetermined distance is preferably within 2 mm, more preferably within 1.5 mm, and even more preferably within 1 mm from the terminal opening (the most distal end of the opening). It is. Further, the length of the cylindrical portion of the engaging portion in the major axis direction should be such that the rod-like operation tool such as the lacrimal endoscope can be locked as described above and the visual field of the lacrimal endoscope can be secured. For example, it may be in the range of 0.3 to 2 mm.
- the end openings 13a and 13b of the tubular portions 14a and 14b are provided with engaging portions 18a and 18b facing the inside of the tubular portions, and the lumen portions 17a and 17b The width has been reduced. Thereby, it can prevent that the front-end
- the structure of the engaging portions 18a and 18b is not particularly limited. As described above, the engaging portions 18a and 18b may be provided continuously along the inner peripheral surface of the cylindrical portion, or may be provided at a predetermined interval.
- the position of the tube-shaped member of the engaging portions 18a and 18b in the major axis direction is not particularly limited, but it is preferable not to disturb the visual field of the lacrimal endoscope, which is shown in FIG. 5 (a). It is preferable to provide at the end of the cylindrical portion 14a as in the form.
- the width in the major axis direction of the engaging portions 18a and 18b can also be set as appropriate in consideration of the visual field of the lacrimal endoscope.
- the engaging portion has a structure protruding inward, but other structures can be adopted as long as the width of the lumen portion can be reduced to prevent the stick-like operation tool from protruding outward. is there.
- a tapered structure or the like in which the width of the lumen portion is gradually reduced toward the end portion in the vicinity of the end opening of the cylindrical portion.
- the positions of the rod-like operation tool openings 16a and 16b are not particularly limited, but the end openings 13a and 1b 3b is preferably formed at a position that is 2/3 or less of the entire length of the tubular members 11a and 11b. Moreover, it is preferable to form in the position which becomes 1/9 or more with respect to the full length of the tubular members 11a and 11b from the terminal openings 13a and 13b.
- Arc-shaped portions 15a and 15b are provided so as to extend further to the central member 12 side from the end portions of the cylindrical portions 14a and 14b on the central member 12 side.
- the arc-shaped portions 15a and 15b have arc-shaped wall portions 19a and 19b in a cross section perpendicular to the major axis direction of the tubular members 11a and 11b (see, for example, FIG. 5B).
- the arc-shaped wall portions 19a and 19b are continuously formed on the arc-shaped portions 15a and 15b over a length (la, lb) of 1/3 to 9/10 of the entire lengths La and Lb of the tubular members 11a and 11b.
- the arc-shaped wall portions 19 a and 19 b are continuously formed in the major axis direction.
- a wall portion having a notch portion that is long and continuous along the axial direction is formed.
- a notch portion that is continuous in a straight line parallel to the long axis direction is formed, but is not limited thereto, the center angle described later is continuously changed along the long axis direction, By continuously changing the position in the circumferential direction of the arc along the long axis direction, the shape of the cutout portion can be appropriately changed.
- the cutout portion is formed, but the arc wall portion may be formed so that the cutout portion is formed.
- both ends of the arc wall in a cross section perpendicular to the long axis direction are in contact with each other in a separable manner.
- the arc wall portions 19a and 19b are formed over the entire length in the major axis direction of the arc-shaped portions 11a and 11b (tubular members 11a and 11b).
- the present invention is not limited to this.
- a substantially arc-shaped wall can be formed at an arbitrary position of the arc-shaped portion.
- the central axis 21a in the major axis direction of the cylindrical portion 14a exists coaxially with the central axis 22a in the major axis direction of the arc-shaped portion 15a, and the shortest distance between the central axis 21a and the cylindrical portion 14a.
- the distance is the same as the shortest distance between the central axis 22a and the arcuate portion 15a (FIG. 5A), but the present invention is not limited to this, and the central axis may not be coaxial.
- the shortest distance may not be the same.
- the central axis of the long axis direction of the shaft and the arc-shaped portion exists on the same axis, and the shortest distance between each central axis, the cylindrical portion and the arc-shaped portion is the same.
- the central axis of the cylindrical portion 14b and the central axis of the arc-shaped portion 15b are the same as those of the cylindrical portion 14a and the arc-shaped portion 15a.
- the central axis in the long axis direction of the cylindrical portion and the arc-shaped portion substantially coincides with the axis corresponding to the central axis in the long axis direction of the rod-shaped operation tool when the tube-shaped member is mounted on the tube-shaped member.
- arc-shaped wall portions 19a and 19b are employed as the substantially arc-shaped wall portions.
- the present invention is not limited to this, and any substantially arc-shaped wall portions may be used.
- substantially arcuate means a state in which a curve, a straight line, a broken line, or a combination thereof is bent in a generally arcuate shape as a whole.
- the degree of bending in the “bending state like a bow” includes from a shape close to a straight line to a shape that is bent until both ends are separably contacted.
- Specific examples of “a state that is bent in a generally bow shape” include, for example, a state in which the whole is bent into an arc shape, a horseshoe shape, a U shape, a U shape, a V shape, a polygonal shape, or the like.
- the “wall portion” means the entire closed portion surrounded by a portion that is in contact with and a portion that is not in contact with the rod-shaped operation tool that is inserted through the cylindrical portion in the cross section of the member that constitutes the tubular member.
- the wall surface side close to the rod-like operation tool and the far wall surface side may have different shapes as long as the entire wall portion has a substantially arc shape.
- the arc-shaped wall portions 19a and 19b show a case where the center angle ⁇ a with respect to the center point 20a in the cross-section perpendicular to the major axis direction of the tubular members 11a and 11b is 270 degrees.
- the present invention is not limited to this, and can be appropriately set as long as a length capable of forming a substantially arc-shaped wall portion can be secured.
- the center angle is preferably 180 degrees or more.
- the center point in the cross section in the direction perpendicular to the major axis direction of the arc-shaped portion exists on the central axis in the major axis direction of the arc-shaped portion described above.
- the center angle with respect to the center point is an angle between two straight lines connecting the center point and the two end portions of the substantially arcuate wall portion (for example, symbol ⁇ a in FIG. 5B). reference.).
- the center angle can be calculated from the distance between the ends of the arc (length of the chord) and the inner and outer diameters when the cross section perpendicular to the major axis direction of the arc-shaped portion is an arc.
- the position of the central point on the central axis of the rod-shaped operating tool having the maximum width that can be inserted into the cylindrical portion and the positions of both ends of the substantially arc-shaped wall portion are relative to the major axis direction of the arc-shaped portion. It is possible to measure by specifying the cross section in the orthogonal direction.
- the substantially arcuate wall portion can be set such that the center angle with respect to the center point in the cross section perpendicular to the major axis direction of the tubular member is arbitrarily set in the major axis direction of the tubular member. it can.
- the central angle is set to be the same in the long axis direction, but there is a portion having a small central angle on the rod-like operation tool opening side in the long axis direction of the tubular member.
- You may comprise a substantially arc-shaped wall part.
- the central angle of the arcuate part gradually decreases from the central member side toward the bar-shaped operating tool opening side (the width of the notch part gradually increases);
- the central angle gradually decreases from the central member side toward the bar-shaped operating tool opening side (the width of the notch portion gradually increases), and further increases gradually toward the bar-shaped operating tool opening side.
- the width of the cutout portion is gradually reduced
- the central angle of the arc-shaped portion on the central member side is not particularly limited, but is preferably 270 degrees or more, more preferably 300 degrees or more, and further preferably 350 degrees or more.
- the notch is large in the vicinity of the opening for the rod-shaped operating tool in the cylindrical portion, and the insertion property of the rod-shaped operating tool is improved, and the portion covering the rod-shaped operating tool is enlarged on the central member side so that the operator can grasp it. Easy to operate.
- the shape of the end of the arcuate portion on the central member side is not particularly limited.
- the ends 23a and 23b of the end are arcuate portions 15a and 15b (tube-like shapes).
- the members 11a and 11b) preferably have a structure orthogonal to the major axis direction.
- the arc-shaped portion 15a has a central axis 22a and a plane including the end 23a.
- the angle ⁇ a is preferably a right angle.
- both ends of the substantially arc-shaped wall for example, the portions indicated by reference numerals 24a and 24b in FIG. 2 and reference numeral 24a in FIG. 5B), but rounding is performed. (For example, refer to FIGS. 6B and 6C described later). This facilitates preventing both ends from coming into contact with each other and damaging the inner wall of the lacrimal passage when inserted into the lacrimal passage.
- the material constituting the tubular member is not particularly limited, and a single material may be used, or a plurality of two or more different materials may be used. Moreover, when using two or more types of different materials, it is preferable that the materials are composed of a plurality of materials having different Shore hardnesses. Further, the plurality of materials having different Shore hardnesses may change the Shore hardness in at least one of a major axis direction of the tubular member, a cross-sectional direction (thickness direction) orthogonal to the major axis direction, and a circumferential direction. Can be placed. Moreover, a single material or a mixture of a plurality of materials can be used as the material having different Shore hardness.
- the Shore hardness as used in the field of this invention means the hardness measured by the method by ASTM2240. Similarly, the hardness in the lacrimal duct tube of the present invention is discriminated by the Shore hardness.
- the tube-shaped member has a structure in which materials with different Shore hardness are laminated in the thickness direction
- the part that slides with the rod-shaped operation tool when the rod-shaped operation tool is mounted that is, the portion closest to the rod-shaped operation tool
- the Shore hardness of the material constituting the material is the highest.
- Such Shore hardness is preferably 57D or more.
- Examples of the material constituting the tubular member include polyolefin resins such as high density polyethylene, low density polyethylene and polypropylene, polyamide resins such as silicone resin, polyamide and polyamide elastomer, polyurethane resins such as polyurethane and polyurethane elastomer, Examples include, but are not limited to, isobutylene copolymers and resin compositions containing these alloys.
- the tube-shaped member has a laminated structure in which materials having different Shore hardnesses are laminated in the thickness direction
- an olefin-based resin as a material constituting the portion that slides with the rod-like operation tool.
- high density polyethylene is particularly preferred. This is advantageous in terms of the slidability between the rod-like operation tool and the tube-shaped member, the balance between flexibility and rigidity, and the ease of laminating with other materials.
- the material constituting the inner layer has higher hardness (for example, the material has a Shore hardness of 57D or more) than the material constituting the outer layer.
- the material constituting the inner layer has higher hardness (for example, the material has a Shore hardness of 57D or more) than the material constituting the outer layer.
- the distal end portion of the tube-shaped member can be made thinner and hardened, and the lesion passing ability can be improved.
- the constituent material of the portion that slides with the rod-shaped operation tool (the portion constituting the innermost layer) is harder than the constituent materials of the other layers, so The friction with the rod-shaped operating tool can also be reduced while further increasing the height.
- the resin portion constituting the outermost side of the tubular member is made of a polyamide elastomer or a mixed material of polyurethane and styrene-isobutylene-styrene block copolymer (SIBS).
- SIBS styrene-isobutylene-styrene block copolymer
- the hardness of the resin part can be adjusted by adjusting the ratio of the polyurethane and SIBS.
- the ratio of polyurethane to SIBS is preferably 1/99 to 99/1 by weight.
- the SIBS is more preferably “SIBSTAR102T” manufactured by Kaneka Corporation.
- the thickness of the layer constituting the portion that slides with the rod-shaped operation tool can be maximized. This is advantageous when the rigidity of the tubular member is required.
- the thickness of the layer depends on the number of layers, it is preferably 40 to 80%, more preferably 65 to 75% of the total thickness.
- the layer constituting the portion that slides with the rod-shaped operation tool of the cylindrical portion may be provided with a notch to facilitate bending of the tubular member.
- a spiral notch By providing a spiral notch, the hardness of the layer that constitutes the sliding part of the cylindrical part and the sliding part is increased to balance the operability of the lacrimal endoscope and the flexibility of the tubular member itself It can be improved well.
- a reinforcing member may be arranged from the vicinity of the central member of the arc-shaped portion to the continuous portion of the isolated portion and the cylindrical portion.
- the structure of the reinforcing member is not particularly limited, and examples thereof include, but are not limited to, one or a plurality of linear bodies extending in the long axis direction (see FIG. 8 described later as an example).
- the material constituting the reinforcing member is not particularly limited as long as it is a material that can be reinforced, and examples thereof include shape memory alloys such as titanium-nickel alloys and metal materials such as stainless steel, but are not limited thereto. is not.
- hydrophilic coating may be provided on the outside of the tubular member.
- the coating exhibits lubricity when in contact with blood and reduces resistance during insertion.
- the type of hydrophilic coating is not particularly limited, and hydrophilic polymers such as poly (2-hydroxyethyl methacrylate), polyacrylamide, polyvinyl pyrrolidone, and polyethylene glycol, or blends thereof are preferably used.
- the tubular member of the present invention can be produced by various methods depending on the structure and materials used. For example, after producing a cylindrical part and an arc-shaped part separately, both may be joined by a conventionally known method such as welding or adhesion, or after forming a cylindrical member by extrusion molding, In order to form a wall part of the cylindrical member, a notch or notch may be formed in a part of the wall part of the cylindrical member to form a cylindrical part and an arc-shaped part, or a desired cylindrical part and an arc-shaped part. It may be molded by injection molding, compression molding, or the like using a mold capable of forming a part, or may be produced by other methods.
- the central member 12 is a member that connects one ends of a pair of tubular members.
- the structure of the central member is not particularly limited, and examples thereof include a cylindrical body and a solid rod (columnar body).
- the thickness of the central member is preferably smaller than the thickness of the tubular member (the maximum width in the cross section perpendicular to the long axis direction).
- the material which comprises a center member can use the material similar to the material which comprises a tubular member.
- the central member 12 and the pair of tubular members can be separately manufactured and joined by a method such as welding or adhesion.
- a lacrimal duct tube provided with a pair of tubular members and a central member that connects the ends thereof is obtained by reducing the diameter of the central portion of the cylindrical member by heating and stretching.
- FIG. 6 schematically shows another embodiment of the lacrimal tube according to the present invention, in which the substantially arc-shaped wall portion of the arc-shaped portion has the above-described configuration (a), and the substantially arc-shaped wall portion. It is an example of what rounding processing was given to both ends.
- the embodiment shown in FIGS. 2 to 5 has substantially the same structure except that the layer structure of the tubular member and the configuration of the substantially arc-shaped wall portion are different.
- the tubular members 31a and 31b include tubular portions 34a and 34b and arc-shaped portions 35a and 35b, and the pair of tubular members 31a and 31b are connected by the central member 12, and the tubular portions 34a and 34b have end openings 33a and 33b and engaging portions 38a and 38b.
- the central axis of the cylindrical portion and the central axis (41b) of the arc-shaped portion exist on the same axis
- the center point (40b) of the arc-shaped wall portion exists on the central axis.
- the substantially arc-shaped wall portions of the tubular members 31a and 31b are arc-shaped wall portions 39a and 39b, and the central member 12 of the arc-shaped portions 35a and 35b.
- the center angle gradually decreases (the width of the notch portion gradually increases gradually) from the end on the side toward the rod-shaped operating tool opening (36a, 36b) side (approximately 8/10 of the total length).
- the central angle ⁇ b was changed from 355 degrees to 350 degrees to the position of the length of), and the reduction rate of the central angle was further increased toward the opening (33a, 33b) for the rod-like operation tool (approximately 8 / of the total length).
- the central angle ⁇ b was changed from 350 ° to 180 ° from the position of the length of 10 to the position of the length of 8.5 / 10), and the central angle further toward the opening for the rod-shaped operation tool (33a, 33b). Is gradually larger The center angle ⁇ b is increased from 180 degrees to 360 degrees from the position of the length of 8.5 / 10 to the position of the length of 9/10. did). That is, in the embodiment shown in FIG. 6, the arc-shaped portions 35a and 35b are formed with elongated straight cutout portions and substantially circular or substantially elliptic cutout portions by the arc wall portions 19a and 19b. Yes. Further, as shown in FIGS.
- both end portions 44b of the arc wall portion 39b are rounded to have an R shape.
- the arc wall portion 39a of the tubular member 31a has a similar structure.
- the tubular member 31b has a three-layer structure. As described above, a layer using a material having the highest Shore hardness among the three layers is formed in the portion that slides with the rod-shaped operation tool (the portion close to the rod-shaped operation tool, referred to as the inner layer 45b). . An intermediate layer 46b is provided outside the inner layer 45b, and an outer layer 47b is provided outside the inner layer 45b. The thickness of the inner layer 45b is maximized.
- the tubular member 31a also has a similar multilayer structure.
- FIG. 7 schematically shows another embodiment of a lacrimal tube according to the present invention, in which the tubular member has a multilayer structure, and the substantially arcuate wall portion of the arcuate portion is the above (c). It is an example of what has a structure and the rounding process was given to the both ends of the substantially arc-shaped wall part.
- the embodiment shown in FIGS. 2 to 5 has substantially the same structure except that the layer structure of the tubular member and the configuration of the substantially arc-shaped wall portion are different.
- the tubular members 51a and 51b include tubular portions 54a and 54b and arc-shaped portions 55a and 55b, and the pair of tubular members 51a and 51b are connected by the central member 12, and the tubular portions 54a and 54b have end openings 53a and 53b and engaging portions 58a and 58b.
- the central axis of the cylindrical portion and the central axis (61b) of the arc-shaped portion exist on the same axis, and the central point (60b) of the arc-shaped wall portion exists on the central axis.
- the lacrimal duct tube 50 according to the embodiment shown in FIG.
- the substantially arc-shaped wall portions of the tubular members 51a and 51b are arc-shaped wall portions 59a and 59b, and the central member 12 of the arc-shaped portions 55a and 55b.
- the center angle ⁇ b was set to 180 degrees), and the center angle gradually increased (the width of the notch portion gradually decreased) toward the rod-shaped operation tool opening (56a, 56b) side (center angle ⁇ b). From 180 degrees to 360 degrees). That is, in the embodiment shown in FIG.
- the arc-shaped portions 55a and 55b are provided with arc-shaped wall portions 59a and 59b, and long and thin linear notches with the same width and substantially semicircular arcs or substantially semi-elliptical arc-shaped notches.
- the part is formed.
- the rounding process is performed to both the edge parts 64b of the circular wall part 59b, and it is R shape.
- the arc wall portion 59a of the tubular member 51a has a similar structure.
- the tubular member 51b has a three-layer multilayer structure.
- a layer using a material having the highest Shore hardness among the three layers is formed in the portion that slides with the rod-shaped operation tool (the portion adjacent to the rod-shaped operation tool, which is the inner layer 65b). .
- An intermediate layer 66b is provided outside the inner layer 65b, and an outer layer 67b is provided outside the inner layer 65b. The thickness of the inner layer 65b is maximized.
- the tubular member 51a also has a similar multilayer structure.
- FIG. 8 schematically shows another embodiment of a lacrimal tube according to the present invention, in which the tubular member has a multilayer structure, and the substantially arcuate wall portion of the arcuate portion is the above (c). It is an example of what has a structure and the rounding process was given to the both ends of the substantially arc-shaped wall part.
- the embodiment shown in FIGS. 2 to 5 has substantially the same structure except that the layer structure of the tubular member and the configuration of the substantially arc-shaped wall portion are different.
- the tubular members 71a and 71b include tubular portions 74a and 74b and arc-shaped portions 75a and 75b, and the pair of tubular members 71a and 71b are connected by the central member 12, and the tubular portions 74a and 74b have end openings 73a and 73b and engaging portions 78a and 78b.
- the central axis of the cylindrical portion and the central axis (81b) of the arc-shaped portion exist on the same axis, and the center point (80b) of the arc-shaped wall portion exists on the central axis.
- the lacrimal duct tube 70 according to the embodiment shown in FIG.
- the substantially arc-shaped wall portions of the tubular members 71a and 71b are arc-shaped wall portions 79a and 79b, and the central member 12 of the arc-shaped portions 75a and 75b.
- the center angle ⁇ b was set to 270 degrees), and the center angle gradually increased (the width of the notch portion gradually decreased) toward the rod-shaped operating tool opening (76a, 76b) side (center angle ⁇ b). From 270 degrees to 360 degrees). That is, in the embodiment shown in FIG.
- the arc-shaped portions 75a and 75b are provided with arc-shaped wall portions 79a and 79b, and long and thin linear notches with the same width and substantially semicircular arcs or substantially semi-elliptical arc-shaped notches.
- the part is formed.
- the rounding process is performed to both the edge parts 84b of the circular-arc wall part 79b, and it is R shape.
- the arc wall portion 79a of the tubular member 71a has a similar structure.
- the tubular member 71b has a three-layered multilayer structure, and the reinforcing members 89a and 89b slide with the rod-shaped operating tool (the portion adjacent to the rod-shaped operating tool, referred to as the inner layer 90b). Is provided inside. As described above, a layer using a material having the highest Shore hardness among the three layers is formed on the inner layer 90b. An intermediate layer 87b is provided outside the inner layer 90b, and an outer layer 88b is provided outside the inner layer 90b, so that the thickness of the inner layer 90b is maximized. In the inner layer 90b, a portion 85b on the side close to the rod-shaped operating tool and a portion 86b on the side close to the intermediate layer are integrated to form one layer.
- the reinforcing member 89b is disposed between a portion indicated by reference numeral 85b and a portion indicated by reference numeral 86b.
- Such a configuration of the inner layer 90b is suitable when the reinforcing members 89b are provided in the inner layer 90b with the portions indicated by reference numerals 85b and 86b being made of the same material.
- a different material may be used for the parts indicated by reference numerals 85b and 86b, and the part indicated by reference numeral 85b and the part indicated by reference numeral 86b may be two layers to form a four-layer structure.
- symbol 85b is the highest among 4 layers, and thickness is also made the largest.
- the tubular member 71a also has a similar multilayer structure.
- the rod-like operation tool used in the present invention is not particularly limited, and examples thereof include an operation rod (bougie) and a lacrimal endoscope.
- the usage method of the lacrimal duct tube concerning this invention is demonstrated easily.
- rod-shaped operating tools 9a and 9b are attached to the lacrimal duct tube 10 shown in FIGS.
- the tube-shaped member 11a is inserted into the lower lacrimal tubule 4, the total lacrimal tubule 5, the lacrimal sac 6, and the nasolacrimal duct 7 together with the rod-shaped operation tool 9a, and the occlusion in the nasolacrimal duct 7 is blocked.
- the site 100 is opened (see FIGS. 1 and 9).
- the blocking member 100 can be pierced at the tip of the tubular member 11a (cylindrical portion 14a) by sliding the tubular member 11a with respect to the rod-shaped operating tool 9a.
- the rod-like operation tool 9a may be a bougie or lacrimal endoscope.
- the other tubular member 11b is inserted into the lower lacrimal tubule 3 from the upper punctum point 1 together with the rod-like operation tool 9b. .
- the arc-shaped portion 15b of the tubular member 11b has an arc-shaped wall portion 15b, the portion can be freely bent without following the rod-shaped operating tool 9b (see FIG. 9). Even if the entire length of the lacrimal tube is short enough to cut the lacrimal tube, the end of the tubular member 11b can be placed at the upper punctum 1. After the tubular member 11b is inserted from the upper punctum 1 to the lower lacrimal tubule 3, the arcuate wall portion 15b is attached to the rod-shaped operation tool 9b and inserted into the occlusion site 100 together with the rod-shaped operation tool 9b. it can.
- the tube-shaped member 11b is slid with respect to the rod-shaped operating tool 9b as necessary, and is closed at the tip of the tube-shaped member 11b (tubular portion 14b).
- the site 100 can be penetrated.
- the combined width of the cylindrical portion 14b into which the rod-shaped operating tool 9b is inserted and the rod-shaped operating tool 9b is the same as the width h1 of the cylindrical portion 14b of the lacrimal duct tube 10 ( FIG. 10B).
- the rod-shaped operating tool 9b and the arcuate portion 15b of the lacrimal tube 10 are overlapped on the central member 12 side from the bar-shaped operating tool opening 16b of the cylindrical portion 14b.
- the width of the overlapped portion 15b is the sum h2 of the thicknesses of the rod-shaped operating tool 9b and the arc wall (see FIG. 10C), and the width h2 is smaller than the width h1. Therefore, unlike the conventional lacrimal tube, it is easy to insert the lacrimal tube 10 into the lacrimal passage beyond the bar-shaped operating tool opening 16b, and the burden on the patient is reduced. Further, since there is no edge (see reference numeral 104 in FIG. 11) on the central member side of the conventional opening on the central member 12 side of the opening 16b for the rod-shaped operating tool, the long axis direction of the rod-shaped operating tool 9b. The movement of the rod-shaped operating tool 9b is easy.
- Example 1 High-density polyethylene (HB530, Nippon Polyethylene Co., Ltd.) with a cross-sectional thickness of 0.150 mm and a Shore hardness of 72D, an intermediate layer with a low-density polyethylene (PX3080, EQISTAR) with a cross-sectional thickness of 0.010 mm and a Shore hardness of 50D, and an outer layer As a mixture (Shore hardness 30D) of polyurethane (Tecoflex EG85A, Noveon) having a cross-sectional thickness of 0.070 mm and a Shore hardness of 30D and SIBS (SIBSTAR102T, Kaneka), an outer diameter of 1.42 mm and an inner diameter of 0.96 mm 3
- the layer tube was molded by a multilayer extrusion method using an extruder.
- a cylindrical member having an outer diameter of 0.70 mm is formed by using an extrusion molding machine from a mixture of polyurethane having a hardness of 30D (TECOFLEX EG85A, Noveon) and SIBS (SIBSTAR102T, Kaneka), and a central member having a total length of 25 mm.
- the side of the tube is cut from a point 11 mm from the tip of a three-layer tube having a total length of 44 mm so that the central angle of the cross section in the direction perpendicular to the long axis direction of the tube is 270 degrees to provide a notch, and the cylindrical portion Part was formed.
- This notch portion is an arc-shaped portion having an arc wall portion.
- the corners formed at both ends of the arc wall were rounded with a gold trowel over the entire long axis direction to obtain a tubular member.
- the central member was disposed between the end portions on the notch portion side of the pair of tubular members thus produced, and the outer layer portion of the tubular member and the end portions of the central member were welded. Thereafter, the inner diameter of the tubular member on the end side was reduced to 0.86 mm to form a locking portion, and a lacrimal tube as shown in FIG. 3 was manufactured.
- Example 2 In the same manner as in Example 1, a three-layer tube was molded by a multilayer extrusion method using an extruder. A central member having a total length of 25 mm was produced in the same manner as in Example 1. The side surface of the tube is cut from a point 30 mm from the tip of a three-layer tube having a total length of 45 mm so that the central angle of the cross section perpendicular to the long axis direction of the tube is 180 degrees, and a notch is provided. Then, rounding of the corners formed at both ends of the arc wall was performed to obtain a tubular member.
- the central member was disposed between the end portions on the notch portion side of the pair of tubular members thus produced, and the outer layer portion of the tubular member and the end portions of the central member were welded. Thereafter, the inner diameter on the distal side of the tubular member was reduced to 0.86 mm to form a locking portion, and a lacrimal tube as shown in FIG. 7 was manufactured.
- Example 3 In the same manner as in Example 1, a three-layer tube was molded by a multilayer extrusion method using an extruder. A central member having a total length of 25 mm was produced in the same manner as in Example 1. From the point of 4.5 mm from the tip of a three-layer tube with a total length of 45 mm, the side of the tube is circular with a diameter of about 0.8 mm, and then the center angle of the cross section perpendicular to the long axis direction of the tube is 350 degrees Cutouts were provided, and the corners formed at both ends of the arc wall were rounded in the same manner as in Example 1 to obtain a tubular member.
- the central member was disposed between the end portions on the notch portion side of the pair of tubular members thus produced, and the outer layer portion of the tubular member and the end portions of the central member were welded. Thereafter, the inner diameter on the distal side of the tubular member was reduced to 0.86 mm to form a locking portion, and a lacrimal tube as shown in FIG. 6 (excluding the shape of the notch) was manufactured.
- Example 4 In the same manner as in Example 1, a three-layer tube was molded by a multilayer extrusion method using an extruder.
- a stainless steel mandrel (outer diameter 0.94 mm) coated with Teflon is passed through the inside of the high-density polyethylene tube having a total length of about 60 mm.
- a stainless steel reinforcing member having a cross-sectional height of 0.10 mm, a width of 0.35 mm, and a length of 35 mm is placed along the outer wall near the center of the high-density polyethylene tube in a state where the mandrel is passed (note that the total length is 60 mm high).
- the vicinity of the center of the high density polyethylene tube and the vicinity of the center of the 35 mm stainless steel reinforcing member are matched, for example, so that the stainless steel reinforcing member does not protrude from both ends of the high density polyethylene tube).
- an inner layer of high-density polyethylene in which a high-density polyethylene tube and an inner layer of high-density polyethylene of a three-layer tube are integrated, an intermediate layer of low-density polyethylene, and an outer layer of a mixture of polyurethane and SIBS And a tube having a maximum thickness of the inner layer and a stainless steel reinforcing member disposed inside the inner layer.
- One end of this tube was cut at a position of 5 mm from the stainless steel reinforcing material toward the one end of the tube, and the cut end was used as a tip, and the other end was cut at a position 45 mm from the tip.
- the side surface of the tube is cut from the tip 20 mm so that the central angle of the cross section in the direction perpendicular to the major axis direction of the tube is 270 degrees, and a notch is provided. Rounded corners formed at both ends were used to form a tubular member.
- the central member was disposed between the end portions on the notch portion side of the pair of tubular members thus produced, and the outer layer portion of the tubular member and the end portions of the central member were welded. Thereafter, the inner diameter at the end of the tubular member was reduced to 0.86 mm to form a locking portion, and a lacrimal duct tube as shown in FIG. 8 was produced.
- Example 5 In the same manner as in Example 1, a three-layer tube was molded by a multilayer extrusion method using an extruder. In the same manner as in Example 4, a tube made of high-density polyethylene (HB530, Nippon Polyethylene) was molded using an extruder. A central member having a total length of 25 mm was produced in the same manner as in Example 1. A shape memory alloy reinforcing member is used in the same manner as in Example 4 except that a shape memory alloy reinforcing member made of a titanium-nickel alloy having a cross-sectional height of 0.10 mm, a width of 0.35 mm, and a length of 35 mm is used. A tube was prepared. A lacrimal tube as shown in FIG. 8 was produced in the same manner as in Example 4 except that this tube was used.
- HB530 high-density polyethylene
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Abstract
Description
〔1〕棒状操作具に沿って摺動可能で、一方端に末端開口部を有する一対のチューブ状部材と、該チューブ状部材の他方端同士を連結する中央部材とを備える涙道チューブであって、
前記チューブ状部材の少なくとも一方は、前記末端開口部から中央部材側に延び、中央部材側の端部に棒状操作具用開口部を有する筒状部分と、該筒状部分の中央部材側の端部から更に中央部材側に延び、チューブ状部材の長軸方向に対する直交方向の断面において略弧状の壁部を有する弧状部分とを備え、
前記の略弧状の壁部が、前記チューブ状部材の全長の1/3以上9/10以下の長さに亘り連続して前記弧状部分に形成されている涙道チューブ。
〔2〕前記の略弧状の壁部が、弧状部分の長軸方向全長に亘り形成されている上記〔1〕記載の涙道チューブ。
〔3〕前記筒状部分の長軸方向の中心軸と前記弧状部分の長軸方向の中心軸が同軸上に存在し、各中心軸と筒状部分及び弧状部分との最短距離が同一である上記〔1〕又は〔2〕記載の涙道チューブ。
〔4〕前記の略弧状の壁部が、弧状部分の長軸方向に対する直交方向の断面における中心点を基準とする中心角度が180度以上になるように連続している上記〔1〕~〔3〕の何れかに記載の涙道チューブ。
〔5〕前記の略弧状の壁部は、弧状部分の長軸方向に対する直交方向の断面における中心点を基準とする中心角度が、弧状部分の長軸方向において前記棒状操作具用開口部側で小さい部分を有する上記〔1〕~〔4〕の何れかに記載の涙道チューブ。
〔6〕前記筒状部分が円筒であり、前記略弧状の壁部が円弧の壁部である上記〔1〕~〔5〕の何れかに記載の涙道チューブ。
〔7〕前記棒状操作具用開口部が、前記末端開口部からチューブ状部材の全長に対して2/3以下となる位置に形成された上記〔1〕~〔6〕の何れかに記載の涙道チューブ。
〔8〕前記の略弧状の壁部は、チューブ状部材の長軸方向に対する直交方向の断面における両端部において、丸め処理が施されている上記〔1〕~〔7〕の何れかに記載の涙道チューブ。
〔9〕前記弧状部分の中央部材側の末端が、弧状部分の長軸方向に対して直交する端部を有する上記〔1〕~〔8〕の何れかに記載の涙道チューブ。
〔10〕前記チューブ状部材が、ショア硬度が異なる複数の材料から構成され、棒状操作具と摺動する部分を構成する材料のショア硬度が最も高い上記〔1〕~〔9〕の何れかに記載の涙道チューブ。
〔11〕棒状操作具と摺動する部分を構成する材料が、オレフィン系樹脂である上記〔10〕記載の涙道チューブ。
〔12〕前記チューブ状部材が多層構造を有し、該多層構造のうち棒状操作具と摺動する部分を構成する層の厚さが最も大きい上記〔10〕又は〔11〕記載の涙道チューブ。
〔13〕前記弧状部分の中央部材近傍部から前記孤状部分と前記筒状部分との連続部分に亘り補強部材が配置された上記〔1〕~〔12〕の何れかに記載の涙道チューブ。
〔14〕前記補強部材が、ステンレス鋼又は形状記憶合金である上記〔13〕記載の涙道チューブ。
また、略弧状の壁部が、弧状部分の長軸方向全長に亘り形成されている場合は、弧状部分の中央部材側の端部を術者が把持して、棒状操作具に沿ってチューブ状部材を摺動させることができる。そのため、棒状操作具として涙道内視鏡を用いる場合に、チューブ状部材が短くても、その筒状部分を涙道内視鏡に先行させ、涙道内視鏡に沿ってチューブ状部材を摺動させることで、閉塞部位を開通する操作を患者の負担を抑制しつつ容易に行うことができる。
本発明でいう涙道とは、図1に示すように、上/下涙点(1/2)、上/下涙小管(3/4)、総涙小管(5)、涙嚢(6)、鼻涙管(7)、鼻腔管(図示せず)、Hasner’s valve(図示せず)から構成され、涙腺(図示せず)から産出された涙液を眼表面から下鼻道(8)へと導く管(眼球付属器)である。尚、上涙点(1)から、上涙小管(3)、総涙小管(5)を経て下鼻道(8)へと導く管を上涙道といい、下涙点(2)から下涙小管(4)、総涙小管(5)、を経て下鼻道(8)へと導く管を下涙道という。
そして、本発明に係る涙道チューブは、上記涙道に挿入、留置し、閉塞部位を開通する際に使用される。
筒状部分14a、14bは、円筒状の形状を有し、その一方の端部に設けられた末端開口部13a、13bから中央部材12側の端部に設けられた棒状操作具用開口部16a、16bに亘り連通し、棒状操作具を挿通するための内腔部17a、17bを備える。本実施形態では、筒状部分14a、14bの形状は円筒状であるが、他の構造を採用しても良い。例えば、筒状部分の内側(棒状操作具が挿通する側)を円筒状の内壁面とし、筒状部分の外側(涙道と接する側)を楕円状の外壁面とする等各種の変形が可能である。尚、筒状部分の形状が円筒であることにより、筒状部分の壁部の厚みを抑制しつつ、所望の強度と柔軟性をより容易に実現することができる。
また、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、内側に突き出た部分が少なくとも1つ以上有する形状でもよい。
また、係合部の筒状部分の長軸方向の長さは、上記のように涙道内視鏡などの棒状操作具を係止でき、かつ涙道内視鏡の視野が確保できる長さであればよく、例えば、0.3~2mmの範囲であればよい。
3bからチューブ状部材11a、11bの全長に対して2/3以下となる位置に形成されるのが好ましい。また、末端開口部13a、13bからチューブ状部材11a、11bの全長に対して1/9以上となる位置に形成されるのが好ましい。
中心角度は、弧状部分の長軸方向に対する直交方向の断面が円弧である場合は、円弧の両端部間の距離(弦の長さ)と内外径から算出することが可能である。また、円弧でない場合は、筒状部分に挿入可能な最大幅を有する棒状操作具の中心軸上の中心点の位置と略弧状の壁部の両端部の位置を、弧状部分の長軸方向に対する直交方向の断面で特定することで測定することが可能である。
また、弧状部分の中央部材側の中心角度としては、特に限定はないが、270度以上が好ましく、300度以上がより好ましく、350度以上が更に好ましい。これにより、筒状部分の棒状操作具用開口部付近では、切り欠きが大きく、棒状操作具の挿入性が向上するとともに、中央部材側では棒状操作具を覆う部分が大きくなり術者が把持し易く操作性が向上する。
本発明でいうショア硬度とは、ASTM2240による方法で測定される硬度をいう。同様に、本発明の涙道チューブにおける硬さは、ショア硬度で高低を判別している。
特に、上記の積層構造において、棒状操作具と摺動する部分(最も内側の層を構成する部分)の構成材料が、他の層の構成材料よりも高硬度であることで、病変部通過性をより高めながら、棒状操作具との摩擦も低減することができる。
前記ポリウレタンとしては、熱可塑性ポリウレタン系樹脂として、エーテル系芳香環式ポリウレタンである日本ミラクトラン社製の「ミラクトランE385PNAT」、ノヴェオン社製「テコタンTT1074A」または、エーテル系脂環式ポリウレタンであるノヴェオン社製の「テコフレックスEG100A」、「テコフレックスEG85A」、または、ポリカーボネート系ポリウレタンであるノヴェオン社製「カルボタンPC3575A」などが好ましい。
また、前記SIBSとしては、カネカ社製の「SIBSTAR102T」がより好ましい。
補強部材を構成する材料としては、補強可能な材料であれば特に限定はなく、例えば、チタン-ニッケル合金等の形状記憶合金、ステンレス鋼等の金属材料が挙げられるが、これらに限定されるわけではない。
中央部材12と一対のチューブ状部材は、それぞれ別途作製して溶着や接着等の方法で接合することができる。また、筒状の部材の中央部を加熱延伸などにより縮径させることで、一対のチューブ状部材とその端同士を連結する中央部材とを備える涙道チューブが得られる。
図6(a)に示す実施形態に係る涙道チューブ30では、チューブ状部材31a、31bの略弧状の壁部は、円弧の壁部39a、39bであり、弧状部分35a、35bの中央部材12側の端部から棒状操作具用開口部(36a、36b)側に向かうに従い漸次緩やかに中心角度が小さくなる(切り欠き部分の幅が漸次緩やかに大きくなる)ようにし(概ね全長の8/10の長さの位置まで中心角度αbを355度から350度にした)、更に棒状操作具用開口部(33a、33b)側に向かうに従い中心角度の減少率をより大きくし(概ね全長の8/10の長さの位置から8.5/10の長さの位置まで中心角度αbを350度から180度にした)、そして更に棒状操作具用開口部(33a、33b)側に向かうに従い中心角度が漸次大きくなる(切り欠き部分の幅が漸次小さくなる)ようにした(概ね全長の8.5/10の長さの位置から9/10の長さの位置まで中心角度αbを180度から360度にした)。即ち、図6に示す実施形態では、弧状部分35a、35bには、円弧の壁部19a、19bにより、細長い直線状の切り欠き部と略円状又は略楕円状の切り欠き部が形成されている。
また、図6(b)、(c)に示すように円弧の壁部39bの両方の端部44bには丸め処理が施され、R形状になっている。図示しないが、チューブ状部材31aの円弧の壁部39aも同様の構造を有している。また、本実施形態では、チューブ状部材31bは3層の多層構造を有する。上記のように、棒状操作具と摺動する部分(棒状操作具に近接する部分。内層45bとする。)に、3層のうちで最もショア硬度が高い材料が用いられた層が形成される。内層45bの外側には中間層46bが設けられ、その外側に外層47bが設けられており、内層45bの厚さが最大になっている。図示しないが、チューブ状部材31aも同様の多層構造を有する。
図7(a)に示す実施形態に係る涙道チューブ50では、チューブ状部材51a、51bの略弧状の壁部は、円弧の壁部59a、59bであり、弧状部分55a、55bの中央部材12側の端部から棒状操作具用開口部(56a、56b)側に向かって同一の中心角度(切り欠き部分の幅が同一)になるようにし(概ね全長の2/3の長さの位置まで中心角度αbを180度にした)、更に棒状操作具用開口部(56a、56b)側に向かうに従い中心角度が漸次大きくなる(切り欠き部分の幅が漸次小さくなる)ようにした(中心角度αbを180度から360度にした)。即ち、図7に示す実施形態では、弧状部分55a、55bには、円弧の壁部59a、59bにより、同一幅の細長い直線状の切り欠き部と略半円弧又は略半楕円孤状の切り欠き部が形成されている。
また、図7(b)に示すように円弧の壁部59bの両方の端部64bには丸め処理が施され、R形状になっている。図示しないが、チューブ状部材51aの円弧の壁部59aも同様の構造を有している。また、本実施形態では、チューブ状部材51bは3層の多層構造を有する。上記のように、棒状操作具と摺動する部分(棒状操作具に近接する部分。内層65bとする。)に、3層のうちで最もショア硬度が高い材料が用いられた層が形成される。内層65bの外側には中間層66bが設けられ、その外側に外層67bが設けられており、内層65bの厚さが最大になっている。図示しないが、チューブ状部材51aも同様の多層構造を有する。
図8(a)に示す実施形態に係る涙道チューブ70では、チューブ状部材71a、71bの略弧状の壁部は、円弧の壁部79a、79bであり、弧状部分75a、75bの中央部材12側の端部から棒状操作具用開口部(76a、76b)側に向かって同一の中心角度(切り欠き部分の幅が同一)になるようにし(概ね全長の5/9の長さの位置まで中心角度αbを270度にした)、更に棒状操作具用開口部(76a、76b)側に向かうに従い中心角度が漸次大きくなる(切り欠き部分の幅が漸次小さくなる)ようにした(中心角度αbを270度から360度にした)。即ち、図8に示す実施形態では、弧状部分75a、75bには、円弧の壁部79a、79bにより、同一幅の細長い直線状の切り欠き部と略半円弧又は略半楕円孤状の切り欠き部が形成されている。
また、図8(b)に示すように円弧の壁部79bの両方の端部84bには丸め処理が施され、R形状になっている。図示しないが、チューブ状部材71aの円弧の壁部79aも同様の構造を有している。また、本実施形態では、チューブ状部材71bは3層の多層構造を有するとともに、補強部材89a、89bが棒状操作具と摺動する部分(棒状操作具に近接する部分。内層90bとする。)の内部に設けられている。上記のように、内層90bに、3層のうちで最もショア硬度が高い材料が用いられた層が形成される。内層90bの外側には中間層87bが設けられ、その外側に外層88bが設けられており、内層90bの厚さが最大になっている。内層90bは、棒状操作具に近接する側の部分85bと中間層に近接する側の部分86bとが一体化され一つの層を形成している。また、補強部材89bは符号85bで示される部分と符号86bで示される部分との間に配置される。このような内層90bの構成は、符号85bと86bで示される部分を同一の材質として補強部材89bを内層90bの内部に設ける場合に好適である。もっとも、符号85bと86bで示される部分に異なる材質を用いて符号85bで示す部分と符号86bで示す部分を二つの層とし、4層構造としてもよい。この場合、符号85bで示す部分のショア硬度は4層のうちで最も高く、厚みも最も大きくするのが好ましい。尚、図示しないが、チューブ状部材71aも同様の多層構造を有する。
図4に示すように、図2、3に示す涙道チューブ10に棒状操作具9a、9bを装着する。次に、例えば、チューブ状部材11aを棒状操作具9aとともに、下涙点2から下涙小管4、総涙小管5、涙嚢6、鼻涙管7に挿入し、鼻涙管7内の閉塞部位100を開通する(図1、9参照)。この時、必要に応じて、棒状操作具9aに対してチューブ状部材11aを摺動させて、チューブ状部材11a(筒状部分14a)の先端で閉塞部位100を穿通させることができる。棒状操作具9aはブジーでも涙道内視鏡でもよい。
次に図9に示すように、一方のチューブ状部材11aを涙道内に挿入した状態で、もう一方のチューブ状部材11bを棒状操作具9bとともに、上涙点1から下涙小管3に挿入する。この時、チューブ状部材11bの弧状部分15bは、円弧の壁部15bを有するため、当該部分は棒状操作具9bに追随することなく自由に曲げることが可能なため(図9参照)、留置後涙道チューブの切断が不要な程度に涙道チューブの全長が短くても、チューブ状部材11bの末端を上涙点1に配置することができる。そして、上涙点1から下涙小管3にチューブ状部材11bを挿入した後は、円弧の壁部15bを棒状操作具9bに添わせて、棒状操作具9bとともに閉塞部位100まで挿入することができる。また、もう一方のチューブ状部材11aの場合と同様に、必要に応じて棒状操作具9bに対してチューブ状部材11bを摺動させて、チューブ状部材11b(筒状部分14b)の先端で閉塞部位100を穿通させることができる。
内層を断面肉厚0.150mm、ショア硬度72Dの高密度ポリエチレン(HB530、日本ポリエチレン社)、中間層を断面肉厚0.010mm、ショア硬度50Dの低密度ポリエチレン(PX3080、EQUISTAR社)、外層を断面肉厚0.070mm、ショア硬度30Dのポリウレタン(テコフレックスEG85A、ノベオン社)とSIBS(SIBSTAR102T、カネカ社)との混合物(ショア硬度30D)として、外径1.42mm、内径0.96mmの3層チューブを押出成形機を用いて多層押出法により成型した。
ショア硬度30Dのポリウレタン(テコフレックスEG85A、ノベオン社)とSIBS(SIBSTAR102T、カネカ社)との混合物を押出成型機を用いて、外径0.70mmの円柱状部材を成型し、全長25mmの中央部材を作製した。
全長44mmの3層チューブの先端から11mmの箇所からチューブ側面をチューブの長軸方向に対する直交方向の断面の中心角度が270度になるように切除して切り欠き部を設け、筒状部分と弧状部分を形成した。この切り欠き部分が円弧の壁部を有する弧状部分である。円弧の壁部の両端部に形成された角を、長軸方向全体に亘り、金ゴテを用いて丸め処理を行ってチューブ状部材とした。
このように作製した一対のチューブ状部材の切り欠き部分側の端部の間に中央部材を配置し、チューブ状部材の外層部分と中央部材の端部を溶着した。その後、チューブ状部材の末端側の内径を0.86mmに減径して係止部を形成し、概ね図3に示すような涙道チューブを製造した。
実施例1と同様にして、3層チューブを押出成形機を用いて多層押出法により成型した。
実施例1と同様にして、全長25mmの中央部材を作製した。
全長45mmの3層チューブの先端から30mmの箇所からチューブ側面をチューブの長軸方向に対する直交方向の断面の中心角度が180度になるように切除し、切り欠き部を設け、実施例1と同様にして円弧の壁部の両端部に形成された角の丸め処理を行って、チューブ状部材とした。
このように作製した一対のチューブ状部材の切り欠き部分側の端部の間に中央部材を配置し、チューブ状部材の外層部分と中央部材の端部を溶着した。その後、チューブ状部材の末端側の内径を0.86mmに減径して係止部を形成し、概ね図7に示すような涙道チューブを製造した。
実施例1と同様にして、3層チューブを押出成形機を用いて多層押出法により成型した。
実施例1と同様にして、全長25mmの中央部材を作製した。
全長45mmの3層チューブの先端から4.5mmの箇所からチューブ側面を直径約0.8mmの円状に、続いてチューブの長軸方向に対する直交方向の断面の中心角度が350度になるように切除し切り欠き部を設け、実施例1と同様にして円弧の壁部の両端部に形成された角の丸め処理を行ってチューブ状部材とした。
このように作製した一対のチューブ状部材の切り欠き部分側の端部の間に中央部材を配置し、チューブ状部材の外層部分と中央部材の端部を溶着した。その後、チューブ状部材の末端側の内径を0.86mmに減径して係止部を形成し、概ね図6(但し切り欠き部分の形状を除く)に示すような涙道チューブを製造した。
実施例1と同様にして、3層チューブを押出成形機を用いて多層押出法により成型した。
外径1.05mm、内径0.95mmのショア硬度72Dの高密度ポリエチレン(HB530、日本ポリエチレン社)製チューブを押出成形機を用いて成型した。
実施例1と同様にして、全長25mmの中央部材を作製した。
全長約60mmの上記高密度ポリエチレン製チューブの内部に、テフロンコーティングされたステンレス製のマンドレル(外径0.94mm)を通す。その後、このマンドレルを通した状態の高密度ポリエチレン製チューブの中央付近の外壁に、断面高さ0.10mm、幅0.35mm、長さ35mmのステンレス製補強部材を沿わせ(なお、全長60mm高密度ポリエチレン製チューブの中心付近と、全長35mmステンレス製補強部材の中心付近とを、例えば一致させるようにして、高密度ポリエチレン製チューブの両端からステンレス製補強部材がはみ出ないようにする)、その上から上記3層チューブを拡張しながら被せた後、外側をシュリンクチューブで押さえながら熱溶着する。そして、マンドレルを抜去すると、高密度ポリエチレン製チューブと3層チューブの内層の高密度ポリエチレンとが一体化された高密度ポリエチレンの内層と、低密度ポリエチレンの中間層と、ポリウレタンとSIBSの混合物の外層との3層で構成され、内層の厚みが最大で内層の内部にステンレス製の補強部材が配置されたチューブを作製した。
このチューブの片端を、ステンレス製補強材から先の片端に向かって5mmの位置で切断し、その切断端を先端とし、さらに、この先端から45mmの位置で他端を切断した。
そして、先端20mmの箇所からチューブ側面をチューブの長軸方向に対する直交方向の断面の中心角度が270度になるように切除し切り欠き部を設け、実施例1と同様にして円弧の壁部の両端部に形成された角の丸め処理を行ってチューブ状部材とした。
このように作製した一対のチューブ状部材の切り欠き部分側の端部の間に中央部材を配置し、チューブ状部材の外層部分と中央部材の端部を溶着した。その後、チューブ状部材の末端側の内径を0.86mmに減径して係止部を形成し、概ね図8に示すような涙道チューブを製造した。
実施例1と同様にして、3層チューブを押出成形機を用いて多層押出法により成型した。
実施例4と同様にして高密度ポリエチレン(HB530、日本ポリエチレン社)製チューブを押出成形機を用いて成型した。
実施例1と同様にして、全長25mmの中央部材を作製した。
断面高さ0.10mm、幅0.35mm、長さ35mmのチタン-ニッケル合金である形状記憶合金製補強部材を用いた以外は実施例4と同様にして、内部に形状記憶合金製の補強部材を配置されたチューブを作製した。
このチューブを用いた以外は、実施例4と同様にして、概ね図8に示すような涙道チューブを製造した。
2 下涙点
3 上涙小管
4 下涙小管
5 総涙小管
6 涙嚢
7 鼻涙管
8 下鼻道
9a、9b 棒状操作具
10 涙道チューブ
11a、11b チューブ状部材
12 中央部材
13a、13b 末端開口部
14a、14b 筒状部分
15a、15b 弧状部分
16a、16b 棒状操作具用開口部
17a、17b 内腔部
18a、18b 係合部
19a、19b 円弧の壁部
20a 中心点
21a 筒状部分の長軸方向の中心軸
22a 弧状部分の長軸方向の中心軸
23a、23b 末端
24a、24b 略弧状の壁部の端部
Claims (14)
- 棒状操作具に沿って摺動可能で、一方端に末端開口部を有する一対のチューブ状部材と、該チューブ状部材の他方端同士を連結する中央部材とを備える涙道チューブであって、
前記チューブ状部材の少なくとも一方は、前記末端開口部から中央部材側に延び、中央部材側の端部に棒状操作具用開口部を有する筒状部分と、該筒状部分の中央部材側の端部
から更に中央部材側に延び、チューブ状部材の長軸方向に対する直交方向の断面において略弧状の壁部を有する弧状部分とを備え、
前記の略弧状の壁部が、前記チューブ状部材の全長の1/3以上9/10以下の長さに亘り連続して前記弧状部分に形成されている涙道チューブ。 - 前記の略弧状の壁部が、弧状部分の長軸方向全長に亘り形成されている請求項1記載の涙道チューブ。
- 前記筒状部分の長軸方向の中心軸と前記弧状部分の長軸方向の中心軸が同軸上に存在し、各中心軸と筒状部分及び弧状部分との最短距離が同一である請求項1又は2記載の涙道チューブ。
- 前記の略弧状の壁部が、弧状部分の長軸方向に対する直交方向の断面における中心点を基準とする中心角度が180度以上になるように連続している請求項1~3の何れかに記載の涙道チューブ。
- 前記の略弧状の壁部は、弧状部分の長軸方向に対する直交方向の断面における中心点を基準とする中心角度が、弧状部分の長軸方向において前記棒状操作具用開口部側で小さい部分を有する請求項1~4の何れかに記載の涙道チューブ。
- 前記筒状部分が円筒であり、前記略弧状の壁部が円弧の壁部である請求項1~5の何れかに記載の涙道チューブ。
- 前記棒状操作具用開口部が、前記末端開口部からチューブ状部材の全長に対して2/3以下となる位置に形成された請求項1~6の何れかに記載の涙道チューブ。
- 前記の略弧状の壁部は、チューブ状部材の長軸方向に対する直交方向の断面における両端部において、丸め処理が施されている請求項1~7の何れかに記載の涙道チューブ。
- 前記弧状部分の中央部材側の末端が、弧状部分の長軸方向に対して直交する端部を有する請求項1~8の何れかに記載の涙道チューブ。
- 前記チューブ状部材が、ショア硬度が異なる複数の材料から構成され、棒状操作具と摺動する部分を構成する材料のショア硬度が最も高い請求項1~9の何れかに記載の涙道チューブ。
- 棒状操作具と摺動する部分を構成する材料が、オレフィン系樹脂である請求項10記載の涙道チューブ。
- 前記チューブ状部材が多層構造を有し、該多層構造のうち棒状操作具と摺動する部分を構成する層の厚さが最も大きい請求項10又は11記載の涙道チューブ。
- 前記弧状部分の中央部材近傍部から前記孤状部分と前記筒状部分との連続部分に亘り補強部材が配置された請求項1~12の何れかに記載の涙道チューブ。
- 前記補強部材が、ステンレス鋼又は形状記憶合金である請求項13記載の涙道チューブ。
Priority Applications (3)
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EP14743347.8A EP2949297B1 (en) | 2013-01-24 | 2014-01-21 | Lacrimal duct tube |
US14/763,075 US10058451B2 (en) | 2013-01-24 | 2014-01-21 | Lacrimal duct tube |
JP2014558565A JP6304042B2 (ja) | 2013-01-24 | 2014-01-21 | 涙道チューブ |
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JP2013011541 | 2013-01-24 | ||
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Cited By (3)
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CN105534640A (zh) * | 2015-07-28 | 2016-05-04 | 李雷 | 用于断裂泪小管吻合和泪道支架同步植入的手术装置及探针 |
JP2019126671A (ja) * | 2018-01-26 | 2019-08-01 | 株式会社カネカ | 涙道チューブ保持台紙 |
WO2022030170A1 (ja) * | 2020-08-05 | 2022-02-10 | ニプロ株式会社 | 涙道チューブ |
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JP6616924B2 (ja) * | 2014-01-22 | 2019-12-04 | 株式会社カネカ | 涙道チューブ |
JP7286657B2 (ja) * | 2018-08-24 | 2023-06-05 | 株式会社カネカ | 涙道内挿管システム |
RU2703977C1 (ru) * | 2019-03-20 | 2019-10-22 | Федеральное государственное бюджетное научное учреждение "Научно-исследовательский институт глазных болезней" | Набор инструментов для интубации слезоотводящих путей и способ интубации слезоотводящих путей |
TR201910229A2 (tr) * | 2019-07-09 | 2021-01-21 | Ondokuz Mayis Ueniversitesi Rektoerluek | Nazolakrimal boşaltım sağlayan tübüler organların sıvı boşaltım kabiliyetinin yeniden kazandırılması için bir entübasyon seti. |
RU2723605C1 (ru) * | 2019-11-20 | 2020-06-16 | Федеральное государственное бюджетное научное учреждение "Научно-исследовательский институт глазных болезней" | Инструмент для получения содержимого слезоотводящих путей для цитологического исследования и способ его получения с помощью этого инструмента |
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EP2949297B1 (en) | 2017-04-05 |
JP6304042B2 (ja) | 2018-04-04 |
EP2949297A4 (en) | 2016-07-06 |
US20150351962A1 (en) | 2015-12-10 |
US10058451B2 (en) | 2018-08-28 |
JPWO2014115700A1 (ja) | 2017-01-26 |
EP2949297A1 (en) | 2015-12-02 |
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