Metallic guide tube

Abstract

Provided is a metallic guide tube that 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.

Description

Metal Guide Tube

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

[0002] Currently, there is a two-step treatment method: administering to patients a drug containing a complex composed of a photosensitizer and a component that selectively accumulates in specific cells, and then irradiating the patient with light of a specific wavelength to which the photosensitizer reacts. A photosensitizer 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 cells are irradiated with light of a specific wavelength, activating the photosensitizer and causing necrosis or elimination of the specific cells through biochemical and physical processes. This treatment is less likely to damage cells other than those specified and has minimal side effects, making it a less burdensome treatment for patients.

[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 specific cells, thereby irradiating light. Depending on the location of the specific cells, the path for inserting the medical device may be complicated, making it difficult to reach or be close to the specific cells.

[0004] The present invention provides a metallic guide tube that allows medical devices to easily reach or approach a therapeutic target site.

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

[0006] The present invention can provide a metallic guide tube that allows a medical device to easily reach or approach a therapeutic target site.

[0007] FIG. 1 is an enlarged view showing an example of a cross section of a material constituting a metal tube according to an embodiment. FIG. 2 is an enlarged view showing an example of a cross section of a material constituting a metal tube according to an embodiment. FIG. 3 is an enlarged view showing an example of a cross section of a material constituting a metal tube according to an embodiment. FIG. 4 is an enlarged view showing an example of a surface of a material constituting a metal tube according to an embodiment. FIG. 5 is a photograph showing an enlarged view of an example of a metal tube according to an embodiment. FIG. 6 is a plan view showing a metal guide tube according to an embodiment. FIG. 7 is a view of the metal guide tube according to the embodiment of FIG. 6 as seen from the side (from the right side of FIG. 6).

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

[0009] In this specification, the side of the metal guide tube that is introduced into the living body in the longitudinal direction 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 A metal guide tube according to a first embodiment will be described below.

[0011] The metallic guide tube according to the first embodiment is deformable and has a shape-retaining function that allows it to retain 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 so as to reach or approach a treatment target site.

[0012] The metallic guide tube is deformable and has a shape-retaining function that allows it to retain its deformed shape. It is sufficient that at least the distal end of the metallic guide tube is deformable and has a shape-retaining function. The metallic guide tube is deformable to the extent that it can be bent and curved in the desired direction. Furthermore, it is more preferable that the metallic guide tube is deformable to the extent that it can be curved and curved in any direction. This allows the metallic guide tube to be deformed into a shape that is easy to introduce, corresponding to the position and shape in the body up to the treatment target site. The metallic guide tube is deformable using a jig such as forceps. Furthermore, it is more preferable that it can be deformed by hand without using a jig. It is preferable that the metallic guide tube has a shape-retaining function that allows it to retain its 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 facilitates introduction according to the position and shape of the body up to the treatment target site, and can maintain the deformed shape, so that the medical device inserted inside the metal guide tube can be easily introduced 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 and laminated. Alternatively, the metal guide tube may be a tube made of a material in which metal wires are formed into a nonwoven fabric. Furthermore, the metal guide tube may be a tube made of a highly flexible metal (e.g., aluminum, etc.). For example, the metal guide tube may be a tube made of metal wires 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 wires 121 having a circular cross-section and wires 122 having an irregular cross-section, such as a triangular cross-section, are alternately interlocked, as shown in FIG. 3 . Furthermore, the metal guide tube may be a so-called interlock tube in which flat metal wires having an S-shaped cross-section are wound into a spring shape and the bent portions 131, 131′ of adjacent wires are interlocked with each other, as shown in FIG. 3 . As mentioned above, it is preferable to use a metal guide tube made of a material in which metal wires are formed into a mesh and laminated. Such a tube has good shape retention, is resistant to internal collapse when bent, has a simple structure, and is relatively inexpensive to manufacture. For example, the following tube can be used as such a tube. As shown in FIG. 4 , a laminate 14 is formed by winding a metal wire around a columnar structure at a predetermined pitch, forming a layer 141, and winding a metal wire around the columnar structure at a predetermined pitch, forming a layer 142. The metal wires constituting the laminate 14 are joined together by welding or the like, and the columnar structure is then removed to obtain a metal guide tube. While FIG. 4 exemplarily illustrates a laminate 14 having two layers, the number of layers is not limited thereto and can be varied depending on the thickness of the metal guide tube. FIG. 5 illustrates a metal guide tube formed with multiple layers. The bending rigidity of the metal guide tube can be adjusted by adjusting the number of layers and the thickness of the metal guide tube.Furthermore, 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 made watertight and airtight. Furthermore, the bending rigidity of the metal guide tube can be freely changed by continuously or stepwise changing the number of layers along the longitudinal axis 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 metal guide tube is preferably made of a metal material such as stainless steel, for example, SUS316L and SUS304 according to the JIS standard.

[0016] The metal guide tube is configured so that a medical instrument can be inserted while being guided inside the metal guide tube, for example, so that the medical instrument can be inserted from the proximal end of the metal guide tube and then 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. Furthermore, 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 the BioBlade® Frontal Diffuser C and BioBlade® Frontal Diffuser H manufactured by Rakuten Medical, Inc., as described below, the inner diameter of the metal guide tube is preferably 2.5 mm or more, and preferably close to 2.5 mm. Furthermore, the medical device may be a therapeutic optical fiber probe having an optical transmission structure capable of outputting light in a predetermined fixed direction and a mirror structure positioned so as to receive the light output from the optical transmission structure. The mirror structure reflects a portion of the received light required for treatment in a direction other than the fixed direction with a reflectance of 90% or more, and generates a light spot exhibiting a uniform light energy distribution throughout 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 configured to decrease stepwise or continuously from the proximal side to the distal side of the metal guide tube. Also, the bending stiffness is 35 N mm within a range of 5 cm from the distal end of the metal guide tube to the proximal side. ２ or more, and 50 N mm ２ When the bending rigidity changes stepwise or continuously in this manner, the metal guide tube can be prevented from breaking even if stress concentrates at the joint between the more deformable portion and the other portion.

[0019] Any medical device having an elongated linear portion at least on the distal side can be used without particular limitations. Examples of such medical devices include fiber optic medical instruments equipped with optical fibers, or needle catheters into which optical fibers are inserted, used in a two-step treatment consisting of administering to a patient a drug containing a complex composed of a photosensitizer and a component that selectively accumulates in specific cells, and irradiating with light of a specific wavelength to which the photosensitizer reacts. Examples of such fiber optic medical instruments include a medical instrument equipped with an optical fiber that guides laser light incident from a laser device and 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. Examples of such fiber optic medical instruments include the BioBlade® Frontal Diffuser C, BioBlade® Frontal Diffuser H, and BioBlade® Cylindrical Diffuser, manufactured by Rakuten Medical, Inc. The needle catheter may be made of a laser-transmitting resin and have a sharp, closed distal end, such as the 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 in a position that is difficult for the above-mentioned medical device to reach or approach, and examples thereof include specific cells in a living body that are located in such a position, such as cancer cells. The living body may be a cavity such as the oral cavity or nasal cavity. Examples of such cancer cells include head and neck cancer cells. Examples of head and neck cancer include pharyngeal cancers such as nasopharyngeal cancer, oropharyngeal cancer, and hypopharyngeal cancer; laryngeal cancers such as glottic cancer, supraglottic cancer, and subglottic cancer; nasal cavity and paranasal sinus cancers such as maxillary sinus cancer; oral cancers such as tongue cancer; salivary gland cancer; and thyroid cancer.

[0021] Second Embodiment A second embodiment of a metal guide tube will be described below with reference to Figures 6 and 7. The description of the same configuration as in the first embodiment will be omitted, as the above description is incorporated herein by reference.

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

[0023] Any metal tube that is deformable and has a shape-retaining function that allows it to retain its deformed shape can be used without any particular limitation as the metal tube 2. As such a metal tube, one similar to the metal guide tube according to the first embodiment can be used.

[0024] The metal support tube 3 allows the operator to stably grasp 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 grasp the metal guide tube 1.

[0026] The metal support tube 3 is preferably made of a metal material such as stainless steel, for example, 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 such 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 shown in Figure 6, which are provided on the side surface of the metal support tube 3 and have a plane parallel to the longitudinal axis of the metal guide tube 1.

[0028] The metal guide tube 1 may further include a spring 4 that protects the joint between the metal tube 2 and the metal support tube 3. This can alleviate strain at the joint when the metal guide tube 1 is bent suddenly, 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 including 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 allows them to retain their deformed shape. Furthermore, the metallic guide tube is configured so that a medical device is inserted while being guided inside the metallic guide tube. Furthermore, by deforming the metallic guide tube, the medical device can be introduced so that it reaches or approaches a treatment target site. Even if the treatment target site is located in a position where it is difficult for the medical device to reach or approach, such a metallic guide tube allows the medical device to easily reach or approach the treatment target site.

[0032] Hereinafter, a method for introducing a medical device into a living body using the metal 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 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 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 living body may be a cavity such as the oral cavity or nasal cavity. The metallic guide tube may be inserted into the living body through the mouth or nose, for example.

[0036] The metallic guide tube is deformed into a shape that is easy to introduce into the body to the treatment target site, corresponding to the shape of the body. The deformation of the metallic guide tube may be performed manually or by using a jig or the like.

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

[0038] The above step (b) of introducing and deforming the metallic guide tube into a living body can be performed, for example, when the treatment target site is located in the oral cavity, as follows: The metallic guide tube is deformed into a shape that facilitates introduction, 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 for the medical device to reach or approach, the medical device can be easily brought to reach or approach the treatment target site by using the metal guide tubes according to the first and second embodiments.

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

[0041] A metallic guide tube similar to metallic guide tube 1 shown in Figure 6 was prepared. Also prepared was a fiber optic medical instrument or a needle catheter into which an optical fiber could be inserted, which would be used in a two-step treatment consisting of administering to a patient a drug containing a complex composed of a photosensitizer and a component that selectively accumulates in specific cells, and then irradiating the patient with light of a specific wavelength to which the photosensitizer responds. The fiber optic medical instrument or needle catheter was inserted into the metallic guide tube while being guided inside the metallic guide tube. The metallic guide tube was then introduced into a living body and deformed so that the fiber optic medical instrument or needle catheter could reach or approach the treatment target site. As a result, the fiber optic medical instrument or needle catheter could easily reach or approach the treatment target site, which was located in a region that was difficult to reach or approach with the fiber optic medical instrument or needle catheter.

Claims

1. A metallic guide tube that is deformable and has a shape retention function that retains the deformed shape, wherein 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.

2. The metal guide tube according to claim 1, comprising: a metal tube that is deformable and has a shape retention function for retaining a deformed shape; and a metal support tube having high rigidity.

3. The metal guide tube according to claim 1, wherein the metal guide tube has a structure in which metal wires are laminated in a mesh form or in a nonwoven fabric form.

4. The metal guide tube according to claim 1, wherein the medical device is an optical fiber medical instrument or a needle catheter into which the optical fiber is inserted, used in a two-step treatment consisting of administering to a patient a drug containing a complex composed of a photosensitive substance and a component that selectively accumulates in specific cells, and irradiating the patient with light of a specific wavelength to which the photosensitive substance reacts.

5. The metallic guide tube according to claim 1, wherein the bending stiffness of the metallic guide tube is configured to decrease stepwise or continuously from the proximal side to the distal side of the metallic guide tube.

6. The metallic guide tube of claim 2, wherein said metallic support tube is connected to said metallic tube.

7. The metallic guide tube according to claim 6, further comprising a member for protecting the joint between said metallic tube and said metallic support tube.

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