Metallic guide tube, device equipped with metallic guide tube, and method for manufacturing metallic guide tube

Abstract

To provide a metallic guide tube that enables a medical instrument to easily reach or come close to a site to be treated.SOLUTION: The metallic guide tube is deformable and has a shape-retaining function for retaining a deformed shape. The metallic guide tube is configured to allow a medical instrument to be inserted therein while being guided by the inside of the metallic guide tube. Deforming the metallic guide tube enables the medical instrument to be introduced so as to reach or come close to a site to be treated.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] The present invention relates to a metallic guide tube. [Background technology]

[0002] Currently, there is a two-step treatment that involves administering to the patient a drug containing a complex composed of a photosensitive substance and a component that selectively accumulates in specific cells, and then irradiating the patient with light of a specific wavelength to which the photosensitive substance reacts. A photosensitive substance is a substance that reacts with light of a specific wavelength range. After administering the drug and allowing it to selectively accumulate in specific cells, the photosensitive substance is activated by irradiating the cells with light of a specific wavelength, causing necrosis or elimination of the specific cells through biochemical and physical processes. The above treatment is a treatment that places a low burden on the patient, as it is unlikely to cause damage to cells other than the specific cells and has few side effects.

[0003] In the above treatment, for example, a medical device for irradiating light may be inserted through the mouth, nose, etc., and the medical device may reach or be close to a specific cell to irradiate light. Depending on the location of the specific cell, the path for inserting the medical device may be complicated, making it difficult to reach or be close to the specific cell. Summary of the Invention [Problem to be solved by the invention]

[0004] The present invention provides a metallic guide tube that allows medical instruments to easily reach or approximate a therapeutic target site. [Means for solving the problem]

[0005] The present invention is a metallic guide tube that is deformable and has a shape retention function that retains the deformed shape, and is configured so that a medical device is inserted while being guided inside the metallic guide tube, and by deforming the metallic guide tube, the medical device can be introduced to reach or be close to a treatment target site. Effect of the Invention

[0006] The present invention provides a metallic guide tube that allows medical instruments to easily reach or approach a therapeutic target site. [Brief description of the drawings]

[0007] [Figure 1] FIG. 1 is an enlarged view showing an example of a cross section of a material constituting a metal tube according to an embodiment. [Diagram 2] FIG. 2 is an enlarged view showing an example of a cross section of a material constituting the metal tube according to the embodiment. [Diagram 3] FIG. 3 is an enlarged view showing an example of a cross section of a material constituting the metal tube according to the embodiment. [Figure 4] FIG. 4 is an enlarged view showing an example of the surface of a material constituting the metal tube according to the embodiment. [Diagram 5] FIG. 5 is a photograph showing an enlarged example of a metal tube according to the embodiment. [Figure 6] FIG. 6 is a plan view showing a metal guide tube according to the embodiment. [Figure 7] FIG. 7 is a side view (from the right side of FIG. 6) of the metal guide tube according to the embodiment of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Hereinafter, an embodiment of the present invention will be described, but the present invention is not limited to the following description. In addition, various modifications and improvements can be made to the embodiment, and such modifications and improvements can also be included in the present invention.

[0009] In this specification, in the longitudinal direction of the metal guide tube, the side that is introduced into the living body is referred to as the distal side, and the side opposite the distal side that is operated by hand is referred to as the proximal side.

[0010] <First embodiment> The metallic guide tube according to the first embodiment will be described below.

[0011] The metallic guide tube according to the first embodiment is deformable and has a shape-retaining function for retaining a deformed shape. The metallic guide tube is configured so that a medical device is inserted while being guided inside the metallic guide tube. By deforming the metallic guide tube, the medical device can be introduced to reach or approach a treatment target site.

[0012] The metal guide tube is deformable and has a shape-retaining function to retain the deformed shape. The metal guide tube may be deformable at least on its distal side and have a shape-retaining function. The metal guide tube is deformable to an extent that it can be curved and bent in a desired direction. Furthermore, it is more preferable that the metal guide tube is deformable to an extent that it can be curved and bent in any direction. This allows the metal guide tube to be deformed into a shape that is easy to introduce in accordance with the position and shape in the living body up to the treatment target site. The metal guide tube is deformable using a jig such as forceps. Furthermore, it is more preferable that the metal guide tube is deformable by hand without using a jig. It is preferable that the metal guide tube has a shape-retaining function to an extent that it can retain the deformed shape until the medical device reaches or approaches the treatment target site.

[0013] Such a metal guide tube can be deformed into a shape that is easy to introduce according to the position and shape of the inside of the body to the treatment target site, and can maintain the deformed shape. Therefore, the above-mentioned metal guide tube can easily introduce a medical device inserted inside the metal guide tube to reach or approach the treatment target site.

[0014] Such a metal guide tube may be, for example, a tube made of a material in which metal wires are formed into a mesh shape and laminated. Also, the metal guide tube may be a tube made of a material in which metal wires are formed into a nonwoven fabric shape. Furthermore, the metal guide tube may be a tube made of a highly flexible metal (for example, aluminum, etc.). For example, the metal guide tube may be a tube in which metal wires are wound into a spring shape and joined together as shown in FIG. 1. Furthermore, the metal guide tube may be a so-called stand tube in which a wire 121 having a circular cross-sectional shape and a wire 122 having an irregular cross-sectional shape such as a triangle are alternately interlocked as shown in FIG. 2. Furthermore, the metal guide tube may be a so-called interlock tube having bent parts 131, 131' at both ends as shown in FIG. 3, in which flat metal wires having an S-shaped cross-sectional shape are wound into a spring shape and the bent parts 131, 131' of adjacent wires are interlocked with each other. As mentioned above, it is preferable to use a tube made of a material in which metal wires are formed into a mesh shape and laminated as the metal guide tube. Such a tube has a good shape retention function, the space inside the tube is not easily crushed when the tube is bent, has a simple structure, and is relatively low in manufacturing cost. For example, the following tube can be used as such a tube. As shown in FIG. 4, a layer 141 is formed by inclining a metal wire in one direction and winding it around a columnar structure at a predetermined pitch, and a layer 142 is formed by inclining a metal wire in another direction different from the one direction and stacking and winding it on the layer 141 at a predetermined pitch around the columnar structure to form a laminate 14. The metal wires constituting the laminate 14 are joined together by welding or the like, and then the columnar structure is pulled out to obtain a metal guide tube. In FIG. 4, the laminate 14 having two layers is illustrated as an example, but the number of layers is not limited to this and can be changed depending on the thickness of the metal guide tube. In FIG. 5, a metal guide tube formed of multiple layers is illustrated. The bending rigidity of the metal guide tube can be adjusted by adjusting the number of layers to adjust the thickness of the metal guide tube.In addition, by sandwiching and bonding one or more layers of metal foil between the laminates, the bending rigidity can be adjusted, and the metal guide tube can be provided with watertightness and airtightness. Furthermore, the bending rigidity of the metal guide tube can be freely changed by continuously or stepwise changing the number of layers in the longitudinal direction of the metal guide tube, by providing a portion in which one or more layers of metal foil are sandwiched and bonded in at least a part of the metal guide tube, or by a combination of these. For example, Fujiflap manufactured by Fuji Filter Co., Ltd. can be used as such a metal guide tube.

[0015] The metallic guide tube is preferably made of a metallic material such as stainless steel, for example SUS316L and SUS304 of the JIS standard.

[0016] The metal guide tube is configured so that the medical device is inserted while being guided inside the metal guide tube. For example, the metal guide tube is configured so that the medical device is inserted from the proximal end of the metal guide tube and inserted along the inside of the metal guide tube toward the distal end of the metal guide tube.

[0017] The inner diameter of the metal guide tube is larger than the diameter of the medical device. This allows the medical device to be inserted while being guided inside the metal guide tube. In addition, the inner diameter of the metal guide tube is preferably close to the diameter of the medical device. This allows the medical device to be well held inside the metal guide tube. When the medical device is BioBlade (registered trademark) Frontal Diffuser C and BioBlade (registered trademark) Frontal Diffuser H manufactured by Rakuten Medical Inc., which will be described later, the inner diameter of the metal guide tube is preferably 2.5 mm or more, and preferably close to 2.5 mm. In addition, as the medical device, a therapeutic optical fiber probe having a light transmission structure capable of outputting light in a preset fixed direction and a mirror structure provided at a position capable of receiving the light output from the light transmission structure can be used. The mirror structure reflects a part of the received light required for treatment in a direction different from the fixed direction with a reflectance of 90% or more, and generates a light spot that exhibits a uniform light energy amount distribution over its entirety.

[0018] It is preferable that the bending stiffness of the metal guide tube obtained by a three-point bending test (based on JIS K7171, span length 15 mm, test speed 1.0 mm / min, bending load when the indenter moves 1.5 mm) is reduced stepwise or continuously from the proximal side to the distal side of the metal guide tube. In addition, the bending stiffness is 35 N mm 2 or more, and 50N·mm 2 In the case where the bending rigidity changes stepwise or continuously in this manner, it is possible to prevent the metal guide tube from being damaged, for example, even if stress is concentrated at the joint between the more deformable portion and the other portion.

[0019] As the medical device, any medical device having a long and thin linear portion at least on the distal side can be used without any particular limitation. As the medical device, for example, an optical fiber medical device having an optical fiber, or a needle catheter into which an optical fiber is inserted, can be used in a two-step treatment consisting of administration to a patient of a drug containing a complex composed of a photosensitive substance and a component that selectively accumulates in a specific cell, and irradiation with light of a specific wavelength to which the photosensitive substance reacts. As the optical fiber medical device, for example, an optical fiber that guides laser light incident from a laser device, and a medical device having an irradiation tip attached to the distal end of the optical fiber for irradiating the laser light from the distal end of the optical fiber at a specific angle and direction can be used. As such an optical fiber medical device, BioBlade (registered trademark) Frontal Diffuser C, BioBlade (registered trademark) Frontal Diffuser H, and BioBlade (registered trademark) Cylindrical Diffuser manufactured by Rakuten Medical, Inc. can be mentioned. As the needle catheter, for example, a needle catheter made of a laser light-transmitting resin and having a shape in which the distal end is sharp and closed can be used. An example of such a needle catheter is BioBlade (registered trademark) needle catheter manufactured by Rakuten Medical, Inc.

[0020] The therapeutic target site is not particularly limited as long as it is located at a position where it is difficult to reach or approach the above-mentioned medical device, and may be a specific cell in a living body located at such a position, such as a cancer cell. The inside of the body is, for example, a cavity such as the oral cavity and nasal cavity. Such cancer cells may be, for example, head and neck cancer cells. Head and neck cancer may be, for example, pharyngeal cancer such as nasopharyngeal cancer, oropharyngeal cancer, and hypopharyngeal cancer, laryngeal cancer such as glottic cancer, supraglottic cancer, and subglottic cancer, nasal and paranasal cancer such as maxillary sinus cancer, oral cancer such as tongue cancer, salivary gland cancer, and thyroid cancer.

[0021] <Second embodiment> Hereinafter, a second embodiment of the metal guide tube will be described with reference to Figures 6 and 7. Descriptions of the same configuration as in the first embodiment will be omitted by citing the above description.

[0022] The metal guide tube 1 according to the second embodiment is deformable and has a shape-retaining function for retaining a deformed shape. The metal guide tube 1 is configured so that a medical device is inserted while being guided inside the metal guide tube 1. By deforming the metal guide tube 1, the medical device can be introduced so as to reach or approach a treatment target site. The metal guide tube 1 according to the second embodiment also includes a metal tube 2 which is deformable and has a shape-retaining function for retaining a deformed shape, and a high-rigidity metal support tube 3.

[0023] As the metal tube 2, any metal tube that is deformable and has a shape retention function for retaining the deformed shape can be used without any particular limitation. As such a metal tube, the same metal guide tube as that according to the first embodiment can be used.

[0024] The metal support tube 3 allows an operator to stably hold the metal guide tube 1. The distal end of the metal support tube 3 is connected to the proximal end of the metal tube 2. The metal support tube 3 may be connected to the proximal end of the metal tube 2 by, for example, brazing, arc welding, laser welding, or the like.

[0025] The metal support tube 3 does not have to be deformable, or it may be deformable and have a deformation retention function, in which case it preferably has higher rigidity than the metal tube 2. This allows the operator to stably hold the metal guide tube 1.

[0026] The metallic support tube 3 is preferably made of a metallic material such as stainless steel, etc. Examples of stainless steel include JIS 316L and SUS304.

[0027] The metal support tube 3 may have a structure for being held by a jig or the like. The shape and number of the structures are not particularly limited as long as the metal support tube 3 can be held by a jig or the like. As an example of such a structure, two structures 6, 6' are provided on the side surface of the metal support tube 3 and have a plane parallel to the long axis of the metal guide tube 1, and are shown in FIG. 6.

[0028] The metal guide tube 1 may further include a spring 4 for protecting the joint between the metal tube 2 and the metal support tube 3. This can reduce strain at the joint when the metal guide tube 1 is suddenly bent, and prevent the joint from being damaged.

[0029] The spring 4 is preferably made of a metal material such as stainless steel, for example, JIS 316L and SUS304.

[0030] The metal guide tube 1 may include a connector 5 provided at the proximal end of the metal support tube 3. The connector 5 may be configured with a known luer taper or the like to which an adapter such as a commercially available Tuohy Borst valved adapter (TBA) and a syringe or the like can be connected. By providing such a connector 5, the metal guide tube 1 can be connected to an adapter, a syringe, or the like.

[0031] The metallic guide tubes according to the first and second embodiments described above are deformable and have a shape-retaining function that retains the deformed shape. Also, the metallic guide tube is configured so that a medical device is inserted while being guided inside the metallic guide tube. Also, by deforming the metallic guide tube, the medical device can be introduced so as to reach or approach the treatment target site. Such a metallic guide tube allows the medical device to easily reach or approach the treatment target site even if the treatment target site is located in a position where it is difficult to reach or approach the medical device.

[0032] Hereinafter, a method for introducing a medical device into a living body using the metallic guide tube according to the first and second embodiments will be described.

[0033] A method for introducing a medical device into a living body using the metal guide tube of the first and second embodiments includes the steps of (a) inserting the medical device into the metal guide tube while guiding the medical device inside the metal guide tube, which is deformable and has a shape-retaining function, and (b) introducing and deforming the metal guide tube into the living body so that the medical device can reach or approach a treatment target site.

[0034] In the above step (a), the medical device is inserted into the metal guide tube while being guided inside the metal guide tube. When the metal guide tube 1 shown in FIG. 6 is used as the metal guide tube, step (a) may be performed as follows. The distal end of the medical device is inserted into the inside of the metal guide tube 1 via the proximal end of the metal support tube 3. The medical device is inserted toward the distal end of the metal guide tube 1 while being guided along the inside of the metal guide tube 1. The medical device is inserted until at least the distal end of the medical device is exposed from the distal end of the metal guide tube 1.

[0035] In the above step (b), the metallic guide tube is inserted into a living body and deformed so that the medical device can reach or approach the treatment target site. The inside of the living body is, for example, a cavity such as the oral cavity or nasal cavity. The metallic guide tube can be inserted into the living body through, for example, the mouth or nose.

[0036] The metallic guide tube is deformed into a shape that is easy to introduce into the body to the treatment target site, in accordance with the shape of the body. The metallic guide tube may be deformed by hand or by using a jig or the like.

[0037] The introduction and deformation of the metallic guide tube may be performed in either order, and may be repeated until the medical device reaches or is in close proximity to the treatment target site.

[0038] The above step (b) of introducing and deforming the metallic guide tube into the living body can be performed, for example, as follows when the treatment target site is located in the oral cavity. The metallic guide tube is deformed into a shape that is easy to introduce, corresponding to the shape of the oral cavity from the patient's mouth to the treatment target site. The metallic guide tube is introduced from the patient's mouth toward the treatment target site, and the distal end of the metallic guide tube is brought close to the treatment target site. This allows at least the distal end of the medical device exposed from the distal end of the metallic guide tube to reach or be close to the treatment target site.

[0039] As described above, even if the treatment target site is located in a position where it is difficult to reach or bring a medical device close to the treatment target site, by using the metal guide tubes of the first and second embodiments, the medical device can be easily brought close to the treatment target site.

[0040] The present invention will be described in more detail below by giving more specific embodiments, but is not limited to these examples.

[0041] As a metal guide tube, a metal guide tube similar to the metal guide tube 1 shown in FIG. 6 was prepared. In addition, an optical fiber medical instrument or a needle catheter into which an optical fiber is inserted was prepared, which is used in a two-step treatment consisting of administration to a patient of a drug containing a complex composed of a photosensitive substance and a component that selectively accumulates in specific cells, and irradiation with light of a specific wavelength to which the photosensitive substance reacts. The optical fiber medical instrument or needle catheter was inserted into the metal guide tube while being guided inside the metal guide tube. Next, the metal guide tube was introduced into a living body and deformed so that the optical fiber medical instrument or needle catheter can reach or approach the treatment target site. As a result, the optical fiber medical instrument or needle catheter could easily reach or approach the treatment target site located in a site where it is difficult to reach or approach the optical fiber medical instrument or needle catheter. [Explanation of symbols]

[0042] 1...metal guide tube, 2...metal tube, 3...metal support tube, 4...spring, 5...connector.

Claims

1. A metal guide tube having a plurality of metal wires, The plurality of metal wires are laminated in a mesh-like structure, or the plurality of metal wires are arranged in a nonwoven fabric-like structure, The metal guide tube is deformable, has a shape retention function that retains the deformed shape, and is configured so that a medical device is inserted while being guided inside the metal guide tube.

2. A metal guide tube as described in claim 1, comprising multiple layers of metal wire.

3. A metal guide tube as described in claim 1, comprising a high-rigidity metal support tube connected to the proximal end of the metal guide tube.

4. A metal guide tube as described in claim 3, wherein the metal support tube is connected to the metal guide tube.

5. A metal guide tube as described in claim 4, further comprising a member for protecting the joint between the metal guide tube and the metal support tube.

6. A metal guide tube as described in claim 1, wherein the plurality of metal wires are made of stainless steel.

7. A metal guide tube as described in claim 1, wherein the bending rigidity of the metal guide tube is configured to decrease gradually or continuously from the proximal side to the distal side of the metal guide tube.

8. A metal guide tube as described in claim 7, wherein the bending stiffness is a value obtained by a three-point bending test in accordance with JIS K7171, in which the bending load is measured when the indenter moves 1.5 mm with a span length of 15 mm and a test speed of 1.0 mm / min.

9. The metal guide tube comprises a laminate, The metal guide tube described in claim 1, wherein the laminate comprises a first layer formed of a plurality of metal wires wound in a columnar shape at a predetermined pitch and tilted in a first direction, and a second layer formed by stacking and winding a plurality of metal wires on top of the first layer and tilting them in a second direction different from the first direction.

10. A metal guide tube as described in Claim 9, wherein the first layer and the second layer are joined to each other.

11. A metal guide tube as described in claim 9, wherein the laminate comprises an additional layer consisting of multiple metal wires wound in a cylindrical shape.

12. A metal guide tube as described in claim 9, wherein a metal foil is sandwiched between the first layer and the second layer.

13. An apparatus comprising the metal guide tube of claim 1 and an optical fiber medical instrument inserted into the metal guide tube.

14. The fiber optic medical device comprising: a frontal diffuser; 14. The device of claim 13, wherein the inner diameter of the metal guide tube is about 2.5 mm.

15. An apparatus comprising the metal guide tube described in claim 1 and a needle catheter inserted into the metal guide tube.

16. A method for manufacturing the metal guide tube according to claim 1, comprising: forming a first layer of a laminate by winding a plurality of metal wires around a columnar structure at a predetermined pitch while inclining in a first direction; forming a second layer of the laminate by stacking a plurality of metal wires on the first layer around the columnar structure and winding them at a predetermined pitch while tilting the metal wires in a second direction different from the first direction; and extracting the columnar structure to obtain the metal guide tube.

17. The manufacturing method described in claim 16, further comprising welding or joining the plurality of metal wires of the laminate.

18. The manufacturing method described in claim 16, wherein one or more additional layers of multiple metal wires are wrapped around the columnar structure.

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