JP6176599B2 - Assembly, insert and dilator - Google Patents

Description

  The present invention relates to a sheath, a hollow dilator to be inserted into the sheath, an assembly in which the insertion tool to be inserted into the dilator is integrated, an insertion tool, and an assembly in which the sheath and the dilator are integrated. In particular, the present invention relates to an assembly used when using a salivary gland endoscope.

  Salivary glands, which are the tissues that make saliva, are divided into major salivary glands and minor salivary glands, and there are parotid glands and submandibular glands. Saliva made from glandular cells passes from the small conduit through the main conduit and is secreted from the opening of the main conduit to the oral cavity. The opening of the main duct of the parotid gland (Stenon's duct) is in the buccal mucosa, and the opening of the main duct of the submandibular gland (Walton's duct) is in the floor of the mouth.

  The calculus salivary stone formed in the Walton tube and the Stenon tube is removed by a salivary tube endoscope (see Non-Patent Document 1). At this time, the salivary tube endoscope is inserted after the opening of the Walton tube or the like is widened. Conventionally, an incision method in which a part of the opening is cut in order to enlarge the opening has been used.

  There is a bougie method as another method of widening the opening (stenosis). In the bougie method, the constricted portion is expanded while changing a conical tube called a bougie from a thin diameter to a thick one.

  In the above-described incision method, after opening the opening, the endoscope is inserted into the salivary gland duct, the endoscope is difficult to put in and out, and the endoscope is repeatedly put in and out, so the damage to the opening increases. Due to the points, there is a problem that the operation time is complicated and the operation time is greatly extended, and the position of the opening portion is not known on the way. In addition, the opening of the Walton tube and the inner wall of the lumen are damaged, and there is a problem of being invasive to the patient. Similarly, the bougie method described above has a problem that the stenosis is expanded while exchanging from a bougie having a small diameter to a bougie having a large diameter, which is complicated and requires an operation time.

  Accordingly, an object of the present invention is to solve the above problems, and provides an assembly or the like that is not complicated and can shorten the operation time and does not obscure the position of the opening partway. There is to do.

  The second object of the present invention is to provide a non-invasive assembly or the like that can guide the sheath and dilator or the sheath without damaging the opening of the Walton tube or the like and the inner wall of the lumen. There is.

The assembly of the present invention is an assembly in which a sheath, a hollow dilator inserted into the sheath and having an insertion portion made of a uniform material , and an insertion tool inserted into the dilator are integrated. The insertion tool has flexibility at the distal end portion side, and the sheath, the dilator, and the insertion tool each have a connector portion that supports a root, and the dilator is inserted into the sheath and is inserted into the sheath. When the connector portion of the dilator is fitted into the connector portion of the sheath, the tip portion of the dilator protrudes a predetermined length from the tip edge of the sheath, and the insertion tool is inserted into the dilator and inserted into the connector portion of the dilator. When the connector portion of the tool is fitted, the distal end portion of the insertion tool protrudes a predetermined length from the distal edge of the dilator.

  Here, in the assembly of the present invention, by releasing the fitting of the connector portion of the sheath and the connector portion of the dilator, the dilator and the insertion tool can be integrally removed from the sheath.

  Here, in the assembly according to the present invention, the sheath has an inner diameter of a tip edge substantially matching an outer diameter of the dilator, and a predetermined gap can be provided between the sheath and the dilator at an inner diameter after the tip edge. .

  Here, in the assembly according to the present invention, the dilator may have an inner diameter of the distal end edge substantially larger than an outer diameter of the insertion tool, and the inner diameter after the distal end edge may be increased in a tapered shape of a predetermined length.

  Here, in the assembly of the present invention, the flexible portion may be a coiled wire.

  Here, in the assembly of the present invention, after the assembly is inserted into the salivary gland duct, the dilator and the insertion tool are integrally removed from the sheath and placed in the salivary gland duct. Entering and exiting the endoscope can be made possible.

  The insertion tool according to the present invention constitutes any of the assemblies according to the present invention.

An assembly according to the present invention is an assembly in which a sheath and a dilator that is inserted into the sheath and includes a flexible portion having flexibility at a distal end portion are integrated with the sheath and the dilator. Each has a connector portion for supporting the base, and when the dilator is inserted into the sheath and the connector portion of the dilator is fitted into the connector portion of the sheath, a part of the flexible portion of the dilator is The sheath protrudes a predetermined length from the leading edge of the sheath , and another portion of the flexible portion opposite to the protruding portion of the predetermined length is inserted into the distal portion of the dilator for a predetermined length so as to be fixed. The inner diameter after the tip edge is formed in a tapered shape having a predetermined length, and the other part of the flexible portion is formed in accordance with the tapered cross-sectional shape .

  Here, in the assembly of the present invention, the dilator can be removed from the sheath by releasing the fitting between the connector portion of the sheath and the connector portion of the dilator.

  Here, in the assembly according to the present invention, the sheath has an inner diameter of a tip edge substantially matching an outer diameter of the dilator, and a predetermined gap can be provided between the sheath and the dilator at an inner diameter after the tip edge. .

  Here, in the assembly of the present invention, the flexible portion may be a coiled wire.

  Here, in the assembly according to the present invention, after the assembly is inserted into the salivary gland duct, the dilator is removed from the sheath and placed in the salivary gland duct, and the salivary gland endoscope can enter and exit the sheath. It can be.

  The dilator of this invention comprises the assembly as described in any of this invention.

  The assembly of the present invention is an assembly in which a sheath, a hollow dilator inserted into the sheath, and a stylet (insertion tool) inserted into the dilator are integrated. The sheath, dilator, and stylet each have a connector portion that supports the root. The insertion portion of the stylet is composed of a flexible portion having flexibility for safely guiding the tip portion into the human body and a slightly thick portion for increasing the rigidity of the insertion portion. The flexible portion is a coiled wire in which a thin stainless steel wire is covered with a stainless steel coil having a wire diameter of 0.07 mm. The insertion site of the dilator is inserted into the sheath through the connector portion of the sheath. A method of fitting the connector portion of the sheath and the connector portion of the dilator is performed by fitting the connector portion of the dilator into a screw shape into the connector portion of the sheath. When fitted, the tip of the dilator protrudes a predetermined length (9 mm) from the tip of the sheath. Next, the insertion site of the stylet is inserted into the dilator through the connector portion of the dilator fitted with the sheath. The fitting method of the connector part of the dilator and the connector part of the stylet is performed by pushing the fitting part of the stylet into the connector part of the dilator. When fitted, the tip of the stylet protrudes a predetermined length (7 mm) from the tip of the dilator. While the assembly is holding the connector part of the sheath with your fingers and rotating the connector part of the dilator with another finger to release the screw-like fitting (fitting), both keep the fitting between the dilator and the stylet. Can be removed from the sheath as a unit. The sheath, dilator and stylet have a three-stage (triple) structure and can be removed one by one.

  The assembly according to the present invention is preferably used for inserting the dilator and the stylet from the sheath after insertion into the salivary gland duct and allowing the salivary gland endoscope to enter and exit from the sheath placed in the salivary gland duct. . Since the distal end portion of the stylet has a flexible portion, it can serve as a guide wire and can guide the subsequent dilator and sheath without damaging the inner wall of the salivary gland lumen. As a result, the sheath and dilator can be guided without damaging the opening of the Walton tube and the inner wall of the salivary gland lumen, and there is an effect that a noninvasive assembly can be provided to the patient. Subsequently, the dilator is rotated and inserted into the opening to further enlarge the opening, and the sheath is also inserted. Thereafter, the dilator and stylet are integrally removed from the sheath, and the sheath is placed in the salivary gland duct to maintain the enlargement of the opening. As described above, the salivary gland endoscope can be moved in and out of the sheath placed in the salivary gland duct. That is, by using the assembly of the present invention, it is not necessary to apply an invasion as in the prior art incision method, and the endoscope can be freely inserted and removed through the sheath. It wo n’t hurt each time. Furthermore, by using the assembly of the present invention, a stylet, a dilator, and a sheath are set instead of a method of expanding a narrowed portion while changing from a thin bougie to a thick bougie like the conventional bougie method. The integrated assembly can be inserted / expanded into the salivary gland duct at a time to maintain the enlargement of the opening, so that the operation time can be reduced and the operation time can be shortened. There is an effect that it is not lost.

  The assembly of the present invention is an assembly in which a sheath and a dilator that is inserted into the sheath and includes a flexible portion having flexibility at the tip portion are integrated. A part of the flexible portion is provided so as to protrude about 7 mm from the tip edge of the tip portion of the dilator. The flexible portion has flexibility to guide safely into the human body, and is a coiled wire in which a thin stainless steel wire (not shown) is covered with a stainless steel coil having a wire diameter of 0.07 mm. The assembly method is performed by inserting the insertion site of the dilator into the sheath through the connector portion of the sheath. A method of fitting the connector portion of the sheath and the connector portion of the dilator is performed by fitting the connector portion of the dilator into a screw shape into the connector portion of the sheath. When fitted, a part of the flexible portion of the dilator and the tip portion of the dilator protrude from the tip edge of the sheath by a predetermined length (7 mm of the flexible portion + 9 mm = 16 mm of the tip portion of the dilator). The inner diameter at the distal end edge of the sheath was 1.5 mm, and the outer diameter of the entire effective length portion excluding a part of the flexible portion and the distal end portion of the dilator was 1.5 mm, and they were designed to be the same. This is because the insertion part of the dilator is passed through the sheath, and a part of the flexible part and the tip part of the dilator are inserted into the human body in a state of protruding from the tip edge of the sheath. This is to reduce the level difference in the area. To release the fitting, the dilator can be removed from the sheath by releasing the screw-like fitting (fitting) by rotating the connector portion of the dilator with another finger while pressing the connector portion of the sheath with a finger. it can. As described above, the sheath and the dilator have a two-stage (double) structure and can be removed one by one. A predetermined gap (clearance of about 0.05 mm) is provided between the inner diameter of the insertion portion of the sheath after the distal end edge of the sheath and the insertion portion of the dilator. This is to reduce the sliding resistance between the insertion site of the dilator. In the dilator, the inner diameter (0.46 mm) of the distal end edge of the distal end portion is substantially larger than the outer diameter (0.445 mm) of the flexible portion, and the inner diameter of the insertion portion after the distal end edge is expanded to a predetermined length (9 mm) taper shape. The diameter is made. The gap between the enlarged diameter portion of the insertion site and the flexible portion is bonded with, for example, an adhesive.

  The assembly of the present invention is used for removing the dilator from the sheath as described above after being inserted into the salivary gland duct, and allowing the salivary gland endoscope to enter and exit in the sheath that is placed in the salivary gland duct and maintains the expansion of the opening. Is preferred. More specifically, the opening of the Stenon tube or the Walton tube is first enlarged using a lacrimal bougie, and the dilator and the sheath are set and integrated into the enlarged opening, and the flexible portion of the dilator is then assembled. insert. The flexible part serves as a guide wire in the prior art and can guide the insertion site and the sheath subsequent to the flexible part of the dilator without damaging the inner wall of the salivary gland lumen. That is, since the insertion site and the sheath after the flexible part of the dilator can be guided without damaging the opening of the Walton tube and the inner wall of the salivary gland lumen, it is possible to perform a noninvasive operation for the patient. Subsequently, the insertion portion after the flexible portion of the dilator is rotated and inserted into the opening to further expand the opening, and the sheath is also inserted. Thereafter, the dilator is removed from the sheath, and the sheath is placed in the salivary gland duct to maintain the enlargement of the opening. As described above, the salivary gland endoscope can be moved in and out of the sheath placed in the salivary gland duct. That is, by using the assembly of the present invention, it is not necessary to apply an invasion as in the prior art incision method, and the endoscope can be freely inserted and removed through the sheath. There is an effect that it is not hurt each time. . Furthermore, by using the assembly of the present invention, the dilator and the sheath are set and integrated, instead of the method of expanding the constricted portion while changing from a thin bougie to a thick bougie like the conventional bougie method. The assembled assembly can be inserted / expanded into the salivary gland duct at once to maintain the enlargement of the opening. For this reason, it is not complicated and the operation time can be shortened, and the position of the opening is not lost during the process. In other words, by using the assembly of the present invention, there is an effect that the bougie method can be realized as a result. In addition, since it has a two-stage (double) structure of a sheath and a dilator, there is an effect that it can be manufactured at a lower cost than an assembly of a three-stage structure.

It is a figure which shows the sheath (sheath for dilators) 10 in Example 1 of this invention. It is a figure which shows the dilator 20 in Example 1 of this invention. It is a figure which shows the stylet (styler for dilators) 30 in Example 1 of this invention. It is a figure which shows the assembly method of the sheath 10, the dilator 20, and the stylet 30 mentioned above. It is a figure which shows the assembly 40 of this invention assembled by the assembly method shown by FIG. FIG. 6 is an enlarged view of a portion P (indicated by a dotted circle) of the assembly 40 shown in FIG. 5. It is a figure which shows the dilator 50 in Example 3 of this invention. It is a figure which shows the assembly method of the sheath 10 and the dilator 50 in Example 3 of this invention. It is a figure which shows the assembly 60 in Example 3 of this invention assembled by the assembly method shown by FIG. FIG. 10 is an enlarged view of a portion Q (indicated by a dotted circle) of the assembly 60 shown in FIG. 9.

  Hereinafter, each embodiment will be described in detail with reference to the drawings.

  The assembly according to the first embodiment of the present invention is an assembly in which a sheath, a hollow dilator inserted into the sheath, and a stylet (insertion tool) inserted into the dilator are integrated. Hereinafter, each component of the assembly will be described in order. FIG. 1 shows a sheath (sheath for dilator) 10 in Embodiment 1 of the present invention. In FIG. 1, reference numeral 12 denotes an insertion site of the sheath 10, 14 denotes a connector portion that supports the root of the sheath 10, 14 a denotes a part of the connector portion 14, and A denotes a distal end portion of the sheath 10 (restricted by a dotted circle). (Portion), 16 is the leading edge of the sheath 10. As shown in FIG. 1, the tip end portion A is tapered (tapered) toward the tip edge 16 in a tapered shape. The material of the sheath 10 is preferably PA (polyamide) resin, and may be PE (polyethylene), PP (polypropylene), PTFE (polytetrafluoroethylene), or ETFE (ethylene tetrafluoroethylene). As shown in FIG. 1, the effective length of the insertion site 12 was 50 mm, the outer diameter of the entire effective length portion excluding the tip portion A was 2.0 mm, and the inner diameter of the tip edge 16 was 1.5 mm. However, each size of the insertion site 12 is not limited to the above size.

  FIG. 2 shows the dilator 20 according to the first embodiment of the present invention. In FIG. 2, reference numeral 22 denotes an insertion site of the dilator 20, 24 denotes a connector portion that supports the root of the dilator 20, B denotes a tip portion of the dilator 20 (a narrowed portion indicated by a dotted circle), and 26 denotes the dilator 20. It is the tip edge. As shown in FIG. 2, the distal end portion B has a tapered diameter (tapered) toward the distal end edge 26. The material of the dilator 20 is preferably FEP (tetrafluoroethylene / hexafluoropropylene copolymer) resin, and may be H-PVC (hard polyvinyl chloride) or HDPE (high density polyethylene). . As shown in FIG. 2, the effective length of the insertion portion 22 is 76 mm, the outer diameter of the entire effective length portion excluding the distal end portion B is 1.5 mm, the inner diameter is 0.85 mm, and the inner diameter at the distal end edge 26 is 0.1 mm. It was 46 mm. That is, the inner diameter is increased from 0.46 mm at the tip edge 26 in a tapered shape, and the inside diameter of the entire effective length portion excluding the tip portion B is 0.85 mm. That is, unlike the conventional dilator, the dilator 20 in the assembly of the present invention has a hollow structure. In addition, each size of the insertion site | part 22 is not limited to the said size.

  As described above, the inner diameter of the distal end edge 16 of the sheath 10 is 1.5 mm, and the outer diameter of the entire effective length portion excluding the distal end portion B of the dilator 20 is 1.5 mm, which are designed to be the same. As will be described later, since the insertion portion 22 of the dilator 20 is passed through the sheath 10 and the distal end portion B of the dilator 20 protrudes from the distal end edge 16 of the sheath 10 as described later, the insertion resistance is minimized. Therefore, it is for reducing the level | step difference in the front-end edge 16 as much as possible.

  FIG. 3 shows a stylet (insertion tool, dilator stylet) 30 according to the first embodiment of the present invention. In FIG. 3, reference numeral 32 is an insertion site of the stylet 30, 34 is a connector part that supports the root of the stylet 30, 34 a is a part of the connector part 34, and C is a tip part of the stylet 30 (indicated by a dotted circle) ., 36 is the leading edge of the stylet 30. As shown in FIG. 3, the insertion site 32 includes a flexible portion 32 a having flexibility for safely guiding the distal end portion C into the human body and a slightly thicker portion 32 b for increasing the rigidity of the insertion site 32. ing. SUS (stainless steel) and PT are suitable for the material of the insertion portion 32, and the flexible portion 32a is a coiled wire in which a thin stainless steel wire (not shown) is covered with a stainless steel coil having a wire diameter of 0.07 mm. . The material of the connector part 34 is the same as that of the sheath 10 and the dilator 20. As shown in FIG. 3, the effective length of the insertion part 32 is 101 mm, the outer diameter of the flexible part 32a is 0.445 mm, and the outer diameter of the slightly thicker part 32b is 0.8 mm. Each size of the insertion site 32 is not limited to the above size.

  FIG. 4 shows a method for assembling the sheath 10, the dilator 20, and the stylet 30 described above. In FIG. 4, the parts denoted by the same reference numerals as those in FIGS. As shown by the arrow in FIG. 4, the insertion portion 22 of the dilator 20 is inserted into the sheath 10 through the connector portion 14 of the sheath 10. The connector portion 14 of the sheath 10 and the connector portion 24 of the dilator 20 are fitted by fitting the connector portion 24 of the dilator 20 into the connector portion 14 of the sheath 10 in a screw shape. As a result, a part 14 a of the connector portion 14 of the sheath 10 is fitted into the connector 24 of the dilator 20. When fitted, the tip portion B of the dilator 20 protrudes from the tip edge 16 of the sheath 10 by a predetermined length (9 mm). Next, the insertion site 32 of the stylet 30 is inserted into the dilator 20 through the connector portion 24 of the dilator 20 in which the sheath 10 is fitted. The connector part 24 of the dilator 20 and the connector part 34 of the stylet 30 are fitted by pushing the connector part 34 of the stylet 30 into the connector part 24 of the dilator 20 and fitting it. As a result, a part 34 a of the connector portion 34 of the stylet 30 is fitted into the connector portion 24 of the dilator 20. When fitted, the tip portion C of the stylet 30 protrudes from the tip edge 26 of the dilator 20 by a predetermined length (7 mm). Contrary to the above order, the stylet 30 is first inserted into the dilator 20 to fit the connector portions 34 and 24, and then the dilator 20 into which the stylet 30 is fitted is inserted into the sheath 10 to connect each connector. Parts 24 and 14 may be fitted.

  FIG. 5 shows an assembly 40 according to the first embodiment of the present invention assembled by the assembling method shown in FIG. In FIG. 5, the parts denoted by the same reference numerals as those in FIGS. As shown in FIG. 5, the total length of the assembly 40 is 125 mm. As described above, the tip portion B of the dilator 20 protrudes from the tip edge 16 of the sheath 10 by a predetermined length (9 mm), and the tip portion C of the stylet 30. A coiled wire having a predetermined length (7 mm) protrudes from the tip edge 26 of the dilator 20. As shown in FIG. 5, a part 14 a of the connector part 14 of the sheath 10 is screwed into and fitted in the connector part 24 of the dilator 20, and a part 34 a of the connector part 34 of the stylet 30. Is inserted into the connector portion 24 of the dilator 20 and fitted. In this state, the connector portion 24 of the dilator 20 is rotated with another finger while pressing the connector portion 14 of the sheath 10 with a finger to release the screw-like fitting (fitting). Both of them can be removed from the sheath 10 as a whole while maintaining the fitting. Thereafter, the connector part 34 of the stylet 30 can be pulled out from the connector part 24 of the dilator 20. Of course, the connector part 34 of the stylet 30 is pulled out from the connector part 24 of the dilator 20 to release the fitting state between them, and then the connector part 24 of the dilator 20 is pushed to the other part while pressing the connector part 14 of the sheath 10 with a finger. The dilator 20 may be pulled out of the sheath 10 by rotating with a finger to release the screw-like fitting (fitting). As described above, the sheath 10, the dilator 20, and the stylet 30 have a three-stage (triple) structure and can be removed one by one.

  6 shows an enlarged view of a portion P (indicated by a dotted circle) of the assembly 40 shown in FIG. In FIG. 6, portions denoted by the same reference numerals as those in FIGS. As shown in FIG. 6, in the sheath 10, the inner diameter of the distal end edge 16 of the distal end portion A substantially matches the outer diameter of the insertion portion 22 of the dilator 20, and is 1.5 mm as described above. This is to reduce the level difference between the insertion portion 12 of the sheath 12 and the insertion portion 22 of the dilator 20 at the distal end edge 16 as much as possible in order to minimize the insertion resistance when inserting the assembly 40 into the human body. A predetermined gap (clearance of about 0.05 mm) is provided between the insertion portion 12 of the dilator 20 and the inner diameter of the insertion portion 12 after the leading edge 16. This is to reduce the sliding resistance between the insertion site 22 of the dilator 20. As shown in FIG. 6, the dilator 20 is configured such that the inner diameter (0.46 mm) of the tip edge 26 of the tip portion B is substantially larger than the outer diameter (0.445 mm) of the flexible portion 32 a of the stylet 30. The inner diameter of the insertion part 22 after 26 is increased in diameter by a predetermined length (9 mm).

  Next, the usage example of the assembly 40 in Example 1 of this invention is demonstrated. After the assembly 40 of the present invention is inserted into the salivary gland duct, the dilator 20 and the stylet 30 are integrally removed from the sheath 10 as described above, and the assembly 40 is placed in the salivary gland duct and maintained in the enlarged opening. It is preferable to use it for entering and exiting the salivary gland endoscope. More specifically, the state of the assembly 40 in which an opening such as a Stenon tube or a Walton tube is first enlarged using a lacrimal bougie, and the stylet 10, dilator 20 and sheath 10 are set and integrated in the enlarged opening. Then, the stylet 30 at the tip is inserted. As described above, since the distal end portion C of the stylet 30 includes the flexible portion 32a, it functions as a guide wire in the prior art and guides the subsequent dilator 20 and the sheath 10 without damaging the inner wall of the salivary gland lumen. be able to. That is, since the sheath 10 and the dilator 20 can be guided without damaging the opening such as the Walton tube and the inner wall of the salivary gland lumen, it is possible to perform a non-invasive operation for the patient. Subsequently, the dilator 20 is rotated and inserted into the opening to further enlarge the opening, and the sheath 10 is also inserted. Thereafter, dilator 20 and stylet 30 are integrally removed from sheath 10, and sheath 10 is placed in the salivary gland duct to maintain the enlargement of the opening. As described above, the salivary gland endoscope can be moved in and out of the sheath 10 placed in the salivary gland duct. That is, by using the assembly 40 of the present invention, it is not necessary to apply invasion as in the prior art incision method, and the endoscope can be freely inserted and removed through the sheath 10, so that the mucous membrane at the entrance portion can be removed. No more hurting each time you put it in or out. Furthermore, by using the assembly 40 of the present invention, the stylet 30, the dilator 20, and the dilator 20 are not a method of expanding the narrowed portion while changing from a thin bougie to a thick bougie like the prior art bougie method. The assembly 40 in which the sheath 10 is set and integrated can be inserted and expanded at once into the salivary gland duct to maintain the enlargement of the opening. For this reason, it is not complicated and the operation time can be shortened, and the position of the opening is not lost during the process. In other words, the bougie method can be realized as a result by using the assembly 40 of the present invention. In the above description, the salivary gland duct is targeted, but the assembly 40 of the present invention may be inserted into a pipe different from the salivary gland duct and the endoscope may be moved in and out of the sheath 10 placed in the duct. Of course.

  As described above, according to the first embodiment of the present invention, the assembly 40 includes the sheath 10, the hollow dilator 20 inserted into the sheath 10, and the stylet (insertion tool) 30 inserted into the dilator 20. Is an integrated assembly. The sheath 10, the dilator 20, and the stylet 30 have connector portions 14, 24, and 34 that support the roots, respectively. The insertion portion 32 of the stylet 30 includes a flexible portion 32a having flexibility for safely guiding the distal end portion C into the human body and a slightly thick portion 32b for increasing the rigidity of the insertion portion 32. The flexible portion 32a is a coiled wire in which a thin stainless steel wire (not shown) is covered with a stainless steel coil having a wire diameter of 0.07 mm. The insertion portion 22 of the dilator 20 is inserted into the sheath 10 through the connector portion 14 of the sheath 10. The connector portion 14 of the sheath 10 and the connector portion 24 of the dilator 20 are fitted by fitting the connector portion 24 of the dilator 20 into the connector portion 14 of the sheath 10 in a screw shape. As a result, a part 14 a of the connector portion 14 of the sheath 10 is fitted into the connector 24 of the dilator 20. When fitted, the tip portion B of the dilator 20 protrudes from the tip edge 16 of the sheath 10 by a predetermined length (9 mm). Next, the insertion site 32 of the stylet 30 is inserted into the dilator 20 through the connector portion 24 of the dilator 20 in which the sheath 10 is fitted. The connector part 24 of the dilator 20 and the connector part 34 of the stylet 30 are fitted by pushing the connector part 34 of the stylet 30 into the connector part 24 of the dilator 20 and fitting it. As a result, a part 34 a of the connector portion 34 of the stylet 30 is fitted into the connector 24 of the dilator 20. When fitted, the tip portion C of the stylet 30 protrudes from the tip edge 36 of the dilator 20 by a predetermined length (7 mm). The assembly 40 rotates the connector part 24 of the dilator 20 with another finger while pressing the connector part 14 of the sheath 10 with a finger to release the screw-like fitting (fitting). Both of them can be removed from the sheath 10 as a whole while maintaining the fitting. The sheath 10, the dilator 20 and the stylet 30 have a three-stage (triple) structure and can be removed one by one.

  The assembly 40 according to the first embodiment of the present invention is inserted into the salivary gland duct, then the dilator 20 and the stylet 30 are integrally removed from the sheath 10 and the salivary gland endoscope enters and exits the sheath 10 placed in the salivary gland duct. It is preferable to use it. Since the distal end portion C of the stylet 30 includes the flexible portion 32a, it can guide the subsequent dilator 20 and the sheath 10 without damaging the inner wall of the salivary gland lumen while serving as a guide wire. That is, since the sheath 10 and the dilator 20 can be guided without damaging the openings such as the Walton tube and the inner wall of the salivary gland lumen, the non-invasive assembly 40 can be provided to the patient. Subsequently, the dilator 20 is rotated and inserted into the opening to further enlarge the opening, and the sheath 10 is also inserted. Thereafter, dilator 20 and stylet 30 are integrally removed from sheath 10, and sheath 10 is placed in the salivary gland duct to maintain the enlargement of the opening. As described above, the salivary gland endoscope can be moved in and out of the sheath 10 placed in the salivary gland duct. That is, the use of the assembly 40 of the present invention eliminates the need for invasion as in the prior art incision method, and allows the endoscope to be inserted and removed freely through the sheath. You wo n’t be hurt each time. Furthermore, by using the assembly 40 of the present invention, the stylet 10, the dilator 20, and the dilator 20 are not a method of expanding the constricted portion while exchanging from a thin bougie to a thick bougie like the prior art bougie method. Since the assembly 40 in which the sheath 10 is set and integrated can be inserted and expanded at once into the salivary gland duct to maintain the enlargement of the opening, it is not cumbersome and the operation time can be shortened. Thus, the position of the opening is not lost. In other words, the bougie method can be realized as a result by using the assembly 40 of the present invention.

  When searching for a salivary stone that may exist in the salivary gland duct, only the stylet 30 of the above-described assembly 40 can be used. If it is difficult to insert into the salivary gland duct in the state of the integrated assembly 40, only the stylet 30 can be inserted in order to confirm the direction to proceed.

  The assembly according to the third embodiment of the present invention is an assembly in which a sheath and a dilator that is inserted into the sheath and includes a flexible portion having flexibility at the distal end portion are integrated. Hereinafter, each component of the assembly will be described in order. First, the sheath is the same as the sheath 10 shown in FIG. 1 of the first embodiment, and the description of the material of the sheath 10, the size of each part, and the like is the same, and therefore the description of the sheath in the third embodiment is omitted.

  FIG. 7 shows a dilator 50 according to the third embodiment of the present invention. In FIG. 7, the parts denoted by the same reference numerals as those in FIG. In FIG. 7, reference numeral 52 denotes an insertion portion of the dilator 50, D denotes a tip portion of the dilator 50 (a thin portion indicated by a dotted circle), 54 denotes a part of a flexible portion provided at the tip portion D of the dilator 50, 56 Is the leading edge of the dilator 50. As is apparent from a comparison between the dilator 50 shown in FIG. 7 and the twentieth shown in FIG. 2, the dilator 50 uses the dilator 20. For example, the connector portion 24 of the dilator 20 is directly connected to the connector portion of the dilator 50. Thus, the insertion site 22 of the dilator 20 constitutes a part of the insertion site 52 of the dilator 50. A part of the flexible part 54 (tip part D) is provided so as to protrude from the tip edge 26 of the dilator 20 by about 7 mm (as will be described later, the other part of the flexible part 54 is the insertion part 22 of the dilator 20). Inside.) Since the material of the dilator 50 is the same as the material of the dilator 20 described above except for the flexible portion 54, description thereof is omitted. As shown in FIG. 7, the effective length of the insertion portion 52 is 83 mm, and the outer diameter of the entire effective length portion excluding a part of the flexible portion 54 (tip portion D) and the tip portion B of the dilator 20 is 1.5 mm. The inner diameter was 0.85 mm, and the inner diameter at the tip edge 26 of the dilator 20 was 0.46 mm. That is, the inner diameter increases from 0.46 mm at the tip edge 26 of the dilator 20 in a taper shape, and the inner diameter of the entire effective length (76 mm, see FIG. 2) of the dilator 20 excluding the tip portion B of the dilator 20 is 0. It is 85 mm. In addition, each size of the insertion part 52 of the dilator 50 is not limited to the said size. The flexible part 54 has flexibility in order to safely guide it into the human body. Similar to the flexible portion 32a of the stylet 30 in the first embodiment, the flexible portion 54 is a coiled wire in which a thin stainless steel wire (not shown) is covered with a stainless steel coil having a wire diameter of 0.07 mm.

  FIG. 8 shows an assembly method of the sheath 10 and the dilator 50 described above. In FIG. 8, the same reference numerals as those in FIGS. As shown by the arrow in FIG. 8, the insertion portion 52 of the dilator 50 is inserted into the sheath 10 through the connector portion 14 of the sheath 10. The connector part 14 of the sheath 10 and the connector part 24 of the dilator 50 are fitted by fitting the connector part 24 of the dilator 50 into the connector part 14 of the sheath 10 in a screw shape. As a result, a part 14 a of the connector portion 14 of the sheath 10 is fitted into the connector 24 of the dilator 50. When fitted, a part (tip portion D) of the flexible portion 54 of the dilator 50 and a tip portion B of the dilator 20 have a predetermined length (7 mm + of a part (tip portion D) of the flexible portion 54) from the tip edge 16 of the sheath 10. The tip portion B of the dilator 20 protrudes (9 mm = 16 mm). As described above, the inner diameter of the distal edge 16 of the sheath 10 is 1.5 mm, and the outer diameter of the entire effective length portion excluding a part of the flexible portion 54 (tip portion D) and the tip portion B of the dilator 20 is 1.5 mm. And designed to be the same. This is done by inserting the insertion portion 52 of the dilator 50 into the sheath 10 and inserting the flexible portion 54 (tip portion D) and the tip portion B of the dilator 20 into the human body in a state of protruding from the tip edge 16 of the sheath 10. Therefore, in order to minimize the insertion resistance, the level difference at the tip edge 16 is reduced as much as possible.

  FIG. 9 shows an assembly 60 according to the third embodiment of the present invention assembled by the assembling method shown in FIG. In FIG. 9, the portions denoted by the same reference numerals as those in FIGS. As shown in FIG. 9, the total length of the assembly 60 is 107 mm. As described above, the tip portion B of the dilator 20 protrudes from the tip edge 16 of the sheath 10 by a predetermined length (9 mm), and the flexible portion 54 of the dilator 50 Part (tip portion D) has a coiled wire of a predetermined length (7 mm) protruding from the tip edge 26 of the dilator 20. As shown in FIG. 9, a part 14 a of the connector portion 14 of the sheath 10 is fitted and fitted into the connector portion 24 of the dilator 50 in a screw shape. In this state, the connector part 24 of the dilator 50 is rotated with another finger while pressing the connector part 14 of the sheath 10 with a finger to release the screw-like fitting (fitting), whereby the dilator 50 is removed from within the sheath 10. Can be extracted. As described above, the sheath 10 and the dilator 50 have a two-stage (double) structure and can be removed one by one. Therefore, the assembly 60 according to the third embodiment can be manufactured at a lower cost than the three-stage structure assembly 40 according to the first embodiment.

  FIG. 10 shows an enlarged view of a portion Q (indicated by a dotted circle) of the assembly 60 shown in FIG. In FIG. 10, the parts denoted by the same reference numerals as those in FIG. In FIG. 10, the display of the sheath 10 is omitted for convenience of explanation, but a predetermined gap is provided between the insertion portion 12 of the dilator 20 at the inner diameter of the insertion portion 12 after the distal end edge 16 of the sheath 10, as in FIG. 6. (Clearance of about 0.05 mm) is provided. This is to reduce the sliding resistance between the insertion site 22 of the dilator 20. As shown in FIG. 10, the dilator 50 is configured such that the inner diameter (0.46 mm) of the tip edge 26 of the dilator 20 is substantially larger than the outer diameter (0.445 mm) of the flexible portion 54, and the insertion site after the tip edge 26. The inner diameter of 52 is expanded to a predetermined length (9 mm) taper. A gap between the insertion portion 22 of the dilator 20 and the other part of the flexible portion 54 in the insertion portion 22 is bonded by, for example, an adhesive 58. Instead of using the adhesive 58, a flexible part 54 having a cross-sectional shape similar to the cross-sectional shape in the insertion site 22 in which another part of the flexible part 54 is contained may be used. In FIG. 10, the length of the other part of the flexible portion 54 included in the insertion site 22 is shown to extend rightward beyond the position of the tip edge 16 (see FIG. 6). This is an example, and if the length is such that the other part of the flexible portion 54 is sufficiently fixed in the insertion site 22, the length is shorter to the left than the position of the tip edge 16. Of course, it is also good.

  Next, a usage example of the assembly 60 of the present invention will be described. After the assembly 60 of the present invention is inserted into the salivary gland duct, the dilator 50 is removed from the sheath 10 as described above, and the salivary gland endoscope enters and exits the sheath 10 which is placed in the salivary gland duct and maintains the expansion of the opening. It is preferable to use it. More specifically, first, an opening such as a Stenon tube or a Walton tube is enlarged using a lacrimal bougie, and the dilator 50 is assembled in a state where the dilator 50 and the sheath 10 are set and integrated in the enlarged opening. A part (tip portion D) of the flexible portion 54 is inserted. A part (tip portion D) of the flexible portion 54 serves as a guide wire in the prior art and guides the subsequent tip portion B of the dilator 20 and the insertion site 12 of the sheath 10 without damaging the inner wall of the salivary gland lumen. be able to. That is, guiding the distal end portion B of the dilator 20 and the insertion portion 12 of the sheath 10 after the flexible portion 54 (the distal end portion D) of the dilator 50 without damaging the opening of the Walton tube and the inner wall of the salivary gland lumen. Therefore, a noninvasive operation can be performed on the patient. Subsequently, the tip portion B of the dilator 20 is rotated and inserted into the opening to further enlarge the opening, and the insertion portion 12 of the sheath 10 is also inserted. Thereafter, the dilator 50 is removed from the sheath 10, and the sheath 10 is placed in the salivary gland duct to maintain the enlargement of the opening. As described above, the salivary gland endoscope can be moved in and out of the sheath 10 placed in the salivary gland duct. That is, by using the assembly 60 of the present invention, it is not necessary to apply invasion as in the prior art incision method, and the endoscope can be freely inserted and removed through the sheath 10, so that the mucous membrane at the entrance portion can be removed. No more hurting each time you put it in or out. Furthermore, by using the assembly 60 of the present invention, the dilator 50 and the sheath 10 are set instead of the method of expanding the constricted portion while replacing the bougie having a small diameter with the thick bougie as in the conventional bougie method. The integrated assembly 60 can be inserted and expanded at once into the salivary gland duct to maintain the enlargement of the opening. For this reason, it is not complicated and the operation time can be shortened, and the position of the opening is not lost during the process. In other words, by using the assembly 60 of the present invention, the bougie method can be realized as a result. In the above description, the salivary gland duct is targeted. However, the assembly 60 of the present invention may be inserted into a pipe different from the salivary gland duct and the endoscope may be moved in and out of the sheath 10 placed in the duct. Of course.

  As described above, according to the third embodiment of the present invention, the assembly 60 includes the sheath 10 and the dilator 50 that is inserted into the sheath 10 and includes the flexible portion 54 having flexibility at the distal end portion D. This is the assembly. The dilator 50 uses the dilator 20 of the first embodiment. For example, the connector portion 24 of the dilator 20 is directly used as the connector portion of the dilator 50, and the insertion portion 22 of the dilator 20 is a part of the insertion portion 52 of the dilator 50. Is configured. A part (tip portion D) of the flexible portion 54 is provided so as to protrude from the tip edge 26 of the dilator 20 by about 7 mm. The flexible part 54 has flexibility in order to safely guide it into the human body. Similar to the flexible portion 32a of the stylet 30 in the first embodiment, the flexible portion 54 is a coiled wire in which a thin stainless steel wire (not shown) is covered with a stainless steel coil having a wire diameter of 0.07 mm. The assembly method of the assembly 60 is performed by inserting the insertion site 52 of the dilator 50 into the sheath 10 through the connector portion 14 of the sheath 10. The connector part 14 of the sheath 10 and the connector part 24 of the dilator 50 are fitted by fitting the connector part 24 of the dilator 50 into the connector part 14 of the sheath 10 in a screw shape. As a result, a part 14 a of the connector portion 14 of the sheath 10 is fitted into the connector 24 of the dilator 50. When fitted, a part (tip portion D) of the flexible portion 54 of the dilator 50 and a tip portion B of the dilator 20 have a predetermined length (7 mm + of a part (tip portion D) of the flexible portion 54) from the tip edge 16 of the sheath 10. The tip portion B of the dilator 20 protrudes (9 mm = 16 mm). As described above, the inner diameter of the distal edge 16 of the sheath 10 is 1.5 mm, and the outer diameter of the entire effective length portion excluding a part of the flexible portion 54 (tip portion D) and the tip portion B of the dilator 20 is 1.5 mm. And designed to be the same. This is done by inserting the insertion portion 52 of the dilator 50 into the sheath 10 and inserting the flexible portion 54 (tip portion D) and the tip portion B of the dilator 20 into the human body in a state of protruding from the tip edge 16 of the sheath 10. Therefore, in order to minimize the insertion resistance, the level difference at the tip edge 16 is reduced as much as possible. The fitting is released by rotating the connector part 24 of the dilator 50 with another finger while pressing the connector part 14 of the sheath 10 with a finger to release the screw-like fitting (fitting). Can be removed from the inside. As described above, the sheath 10 and the dilator 50 have a two-stage (double) structure and can be removed one by one. Therefore, the assembly 60 according to the third embodiment can be manufactured at a lower cost than the three-stage structure assembly 40 according to the first embodiment. Similar to the first embodiment, a predetermined gap (a clearance of about 0.05 mm) is provided between the insertion portion 12 of the dilator 20 and the inner diameter of the insertion portion 12 after the distal end edge 16 of the sheath 10. This is to reduce the sliding resistance between the insertion site 22 of the dilator 20. In the dilator 50, the inner diameter (0.46 mm) of the tip edge 26 of the dilator 20 is substantially larger than the outer diameter (0.445 mm) of the flexible portion 54, and the inner diameter of the insertion portion 52 after the tip edge 26 is a predetermined length (9 mm). ) The diameter is increased in a tapered shape. A gap between the insertion portion 22 of the dilator 20 and the other part of the flexible portion 54 in the insertion portion 22 is bonded by, for example, an adhesive 58. Instead of using the adhesive 58, a flexible part 54 having a cross-sectional shape similar to the cross-sectional shape in the insertion site 22 in which another part of the flexible part 54 is contained may be used. In FIG. 10, the length of the other part of the flexible portion 54 included in the insertion site 22 is shown to extend rightward beyond the position of the tip edge 16 (see FIG. 6). This is an example, and if the length is such that the other part of the flexible portion 54 is sufficiently fixed in the insertion site 22, the length is shorter to the left than the position of the tip edge 16. Of course, it is also good.

  After the assembly 60 according to the third embodiment of the present invention is inserted into the salivary gland duct, the dilator 50 is removed from the sheath 10 as described above, and the dilator 50 is placed in the salivary gland in the sheath 10 that is placed in the salivary gland duct and maintains the opening. It is preferable to use it for entering and exiting the endoscope. More specifically, first, an opening such as a Stenon tube or a Walton tube is enlarged using a lacrimal bougie, and the dilator 50 is assembled in a state where the dilator 50 and the sheath 10 are set and integrated in the enlarged opening. A part (tip portion D) of the flexible portion 54 is inserted. A part (tip portion D) of the flexible portion 54 serves as a guide wire in the prior art and guides the subsequent tip portion B of the dilator 20 and the insertion site 12 of the sheath 10 without damaging the inner wall of the salivary gland lumen. be able to. That is, guiding the distal end portion B of the dilator 20 and the insertion portion 12 of the sheath 10 after the flexible portion 54 (the distal end portion D) of the dilator 50 without damaging the opening of the Walton tube and the inner wall of the salivary gland lumen. Therefore, a noninvasive operation can be performed on the patient. Subsequently, the tip portion B of the dilator 20 is rotated and inserted into the opening to further enlarge the opening, and the insertion portion 12 of the sheath 10 is also inserted. Thereafter, the dilator 50 is removed from the sheath 10, and the sheath 10 is placed in the salivary gland duct to maintain the enlargement of the opening. As described above, the salivary gland endoscope can be moved in and out of the sheath 10 placed in the salivary gland duct. That is, by using the assembly 60 of the present invention, it is not necessary to apply invasion as in the prior art incision method, and the endoscope can be freely inserted and removed through the sheath 10, so that the mucous membrane at the entrance portion can be removed. No more hurting each time you put it in or out. Furthermore, by using the assembly 60 of the present invention, the dilator 50 and the sheath 10 are set instead of the method of expanding the constricted portion while replacing the bougie having a small diameter with the thick bougie as in the conventional bougie method. The integrated assembly 60 can be inserted and expanded at once into the salivary gland duct to maintain the enlargement of the opening. For this reason, it is not complicated and the operation time can be shortened, and the position of the opening is not lost during the process. In other words, by using the assembly 60 of the present invention, the bougie method can be realized as a result. In the above description, the salivary gland duct is targeted. However, the assembly 60 of the present invention may be inserted into a pipe different from the salivary gland duct and the endoscope may be moved in and out of the sheath 10 placed in the duct. Of course.

  When searching for a salivary stone that may exist in the salivary gland duct, only the dilator 50 of the above-described assembly 60 can be used. If it is difficult to insert into the salivary gland duct in the state of the integrated assembly 60, only the dilator 50 can be inserted in order to confirm the direction to proceed.

  As an application example of the present invention, it can be used for salivary gland endoscopic surgery.

  10 Sheath, 12, 22, 32, 52 Insertion site, 14, 24, 34 Connector, 14a, 34a Part of connector, 16, 26, 36, 56 Tip edge, 20 Dilator, 30 Stylet, 32a, 54 Flexible part 32b Slightly thicker part, 40, 60 assembly, 58 Adhesive.

“About Salivary Endoscope”, [online], Tokyo Women's Medical University, Department of Otolaryngology, [Search April 9, 2012], Internet, <https://www.twmu.ac.jp/TWMU/Medicine /RinshoKouza/121/sialoendoscope.html>

Claims (13)

An assembly in which a sheath, a hollow dilator inserted into the sheath and having an insertion portion made of a uniform material , and an insertion tool inserted into the dilator are integrated. The distal end portion side has flexibility, and the sheath, the dilator, and the insertion tool each have a connector portion that supports the root,
When the dilator is inserted into the sheath and the connector portion of the dilator is fitted into the connector portion of the sheath, the tip portion of the dilator projects a predetermined length from the tip edge of the sheath,
When the insertion tool is inserted into the dilator and the connector portion of the insertion tool is fitted into the connector portion of the dilator, the distal end portion of the insertion tool projects a predetermined length from the distal edge of the dilator. Assembly.   2. The assembly according to claim 1, wherein the dilator and the insertion tool can be integrally removed from the sheath by releasing the fitting of the connector portion of the sheath and the connector portion of the dilator. Assembly.   3. The assembly according to claim 1, wherein the sheath has an inner diameter of a leading edge substantially matching an outer diameter of the dilator, and a predetermined gap is provided between the sheath and the inner diameter after the leading edge. An assembly characterized by. 4. The assembly according to claim 1, wherein the dilator has an inner diameter of a distal end edge substantially larger than an outer diameter of the insertion tool, and an inner diameter after the distal end edge is increased in a tapered shape of a predetermined length. An assembly characterized by having been made . 5. The assembly according to claim 1 , wherein the flexible portion is a coiled wire. The assembly according to any one of claims 2 to 5, after which the assembly is inserted into the salivary gland tube, the dilator and the insertion member is in said sheath which is placed in the removal by salivary gland tube from said sheath integrally The assembly is characterized in that the salivary gland endoscope can be moved in and out. An insertion tool comprising the assembly according to any one of claims 1 to 6 . An assembly in which a sheath and a dilator inserted into the sheath and having a flexible portion having flexibility at a distal end portion are integrated, and the sheath and the dilator each support a base Have
When the dilator is inserted into the sheath and the connector portion of the dilator is fitted into the connector portion of the sheath, a part of the flexible portion of the dilator protrudes a predetermined length from the distal edge of the sheath ,
The other part of the flexible part opposite to the part protruding a predetermined length is inserted into the tip of the dilator for a predetermined length to be fixed,
An inner diameter after the tip edge of the dilator is formed in a tapered shape having a predetermined length, and the other part of the flexible portion is formed in accordance with the tapered cross-sectional shape . 9. The assembly according to claim 8 , wherein the dilator can be removed from the sheath by releasing the fitting of the connector portion of the sheath and the connector portion of the dilator. 10. The assembly according to claim 8 or 9 , wherein the sheath has an inner diameter of a leading edge substantially matching an outer diameter of the dilator, and a predetermined gap is provided between the sheath and the inner diameter after the leading edge. An assembly characterized by. The assembly according to any one of claims 8 to 10, an assembly wherein the flexible portion is a coiled wire. The assembly according to any one of claims 9 to 11 , wherein the dilator is removed from the sheath and placed in the salivary gland duct after the assembly is inserted into the salivary gland duct. An assembly characterized in that the mirror can enter and exit. A dilator comprising the assembly according to any one of claims 8 to 12 .

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