WO2023047710A1

WO2023047710A1 - Light irradiating medical device, and method for manufacturing light irradiating medical device

Info

Publication number: WO2023047710A1
Application number: PCT/JP2022/022437
Authority: WO
Inventors: 弘規 ▲高▼田
Original assignee: 株式会社カネカ
Priority date: 2021-09-27
Filing date: 2022-06-02
Publication date: 2023-03-30

Abstract

The present invention relates to a light irradiating medical device (1) and a method for manufacturing the light irradiating medical device (1), in which the light irradiating medical device (1) is provided with: a resin tube (10) which has a tapered diameter part (14) having a structure such that an inner cavity (11) is tapered toward the distal end side; an optical fiber (20) which is arranged in the inner cavity (11) of the resin tube (10), extends in a predetermined zone in the distal end part along the longer axis direction (x) of the resin tube (10), and has a light diffusion part (21) capable of ejecting light outward in the direction of the diameter of the resin tube (10); and a coil member (40) which is arranged in the inner cavity (11) of the resin tube (10), and around which a wire material (42) is wound in a spiral manner so as to be circulated around the optical fiber (20). In the light irradiating medical device (1), the distal end part of the coil member (40) and the inner surface of the tapered diameter part (14) are came into contact with each other.

Description

Photoirradiation medical device and method for manufacturing photoirradiation medical device

The present invention relates to a light irradiation medical device for irradiating light to tissues such as cancer cells in body lumens such as blood vessels and gastrointestinal tracts, and a method for manufacturing the light irradiation medical device.

In photodynamic therapy (PDT), a photosensitizer is administered into the body by intravenous injection or intraperitoneal injection, and the photosensitizer is accumulated in target tissues such as cancer cells, and light of a specific wavelength is used. to excite the photosensitizer. An energy transfer occurs when the excited photosensitizer returns to the ground state, generating reactive oxygen species. Target tissue can be removed by attacking the target tissue with reactive oxygen species. In ablation using laser light, a target tissue is irradiated with laser light and cauterized. An apparatus for performing such light irradiation has been proposed.

Patent documents 1 and 2 disclose a tube in which an optical fiber through which laser light from a laser oscillator is guided is inserted, and which is filled with a predetermined liquid that absorbs the laser light emitted from the tip of the optical fiber. , and a reinforcing member made of a material having a high melting point and a predetermined rigidity that can withstand the heat generated by the optical fiber is provided on the inner surface of the tube. Further, it is disclosed that the reinforcing member can be composed of a coil-shaped member in order to improve the operability of the catheter, and it is disclosed that it functions as a stopper against which the tip of the optical fiber hits.

JP 2005-152094 A JP 2005-152093 A

However, in order to irradiate the entire target tissue such as a tumor, the front irradiation type light irradiation device described in Patent Document 1 and Patent Document 2 needs to emit light at a certain location and then irradiate the target tissue. It was necessary to repeat the operation of slightly shifting the position of the light-emitting part and emitting the light again several times. In addition, irradiation may be difficult depending on the location and shape of the tumor. In addition, since the reinforcing member as described in Patent Documents 1 and 2 is provided on the distal side of the distal end of the optical fiber, it is difficult to sufficiently reduce the diameter of the tube itself. When treating lesions in thin tubes such as the lungs, the optical fiber cannot be inserted close to the affected area. In addition, when trying to make the tube thinner, there is a limit to the size and number of members that can be placed in the inner cavity, so it is difficult to increase the operability while reducing the diameter. SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a light irradiation medical device and a method for manufacturing the light irradiation medical device that can increase treatment efficiency and improve operability by bringing the optical fiber closer to the affected area.

One embodiment of the photoirradiation medical device of the present invention that can achieve the above objects is as follows.
[1] A resin tube having a reduced diameter portion that narrows the lumen toward the distal side; and an optical fiber having a light diffusing portion that emits light outward in the radial direction of the resin tube; wherein the distal end of the coil member and the inner surface of the reduced diameter portion are in contact.
In the light irradiation medical device, the diameter of the resin tube itself can be easily reduced. As a result, it is easy to insert into a thin tube, the optical fiber can be brought closer to the affected area, and the treatment efficiency can be improved. In addition, since the presence of the coil member can impart appropriate rigidity, it is possible to improve operability while reducing the diameter.
[2] The light irradiation medical device according to [1], in which the light diffusing part is arranged on the distal side of the distal end of the coil member.
[3] The light irradiation medical device according to [1] or [2], in which the inner surface of the resin tube and the outer peripheral surface of the light diffusion portion are in contact with each other.
[4] The light irradiation medical device according to any one of [1] to [3], in which the inner surface of the resin tube proximal to the reduced diameter portion is not in contact with the outer peripheral surface of the optical fiber.
[5] The light irradiation according to any one of [1] to [4], further comprising a handle connected to the proximal portion of the resin tube, wherein the proximal portion of the coil member is fixed to the handle. medical device.
[6] The light irradiation medical device according to any one of [1] to [5], wherein the wire is in contact with the inner surface of the resin tube over its entire length.
[7] The light irradiation medical device according to any one of [1] to [6], wherein the outer peripheral surface of the optical fiber and the inner peripheral surface of the coil member are fixed.

One embodiment of the method for manufacturing a photoirradiation medical device according to the present invention, which can achieve the above objects, is as follows.
[8] A resin tube, an optical fiber having a light diffusing portion extending in the longitudinal direction of the resin tube in a predetermined section of the distal portion and emitting light outward in the radial direction of the resin tube; preparing a member and a core material having a first region with a predetermined outer diameter and a second region with a larger outer diameter than the first region; inserting; heating the resin tube to thermally shrink the resin tube to form a reduced diameter portion that narrows the lumen distally with respect to the resin tube; Manufacture of a photoirradiation medical device comprising the steps of: taking out a material; placing a cylindrical member and an optical fiber in a lumen of a resin tube; Method.
According to the manufacturing method of the above-described light irradiation medical device, the resin tube itself can be easily made thin, the light irradiation medical device can be easily inserted into a thin tube, and the optical fiber can be brought closer to the affected area. This can improve treatment efficiency. In addition, the existence of the cylindrical member can impart moderate rigidity, so that it is possible to provide a light irradiation medical device that is small in diameter and has good operability.
[9] The method for manufacturing a light irradiation medical device according to [8], wherein the inner surface of the resin tube on the distal side of the reduced diameter portion is in contact with the outer peripheral surface of the light diffusing portion.
[10] The method for manufacturing a light irradiation medical device according to [8] or [9], wherein the inner surface of the resin tube on the proximal side of the reduced diameter portion is not in contact with the outer peripheral surface of the optical fiber.

Another embodiment of the method for manufacturing a photoirradiation medical device according to the present invention, which has achieved the above object, is as follows.
[11] A first resin tube, a second resin tube having an inner diameter larger than that of the first resin tube, and extending in the longitudinal direction of the first resin tube and the second resin tube in a predetermined section of the distal portion. preparing an optical fiber having a light diffusing portion that emits light outward in the radial direction of at least one of the first resin tube and the second resin tube; and a cylindrical member; forming a resin tube by connecting a second resin tube to the proximal portion and forming a reduced diameter portion with a narrower lumen toward the distal side of the resin tube; placing in the lumen of a tube and bringing the distal end of the tubular member into contact with the inner surface of the reduced diameter portion.
According to the manufacturing method of the above-described light irradiation medical device, the resin tube itself can be easily made thin, the light irradiation medical device can be easily inserted into a thin tube, and the optical fiber can be brought closer to the affected area. This can improve treatment efficiency. In addition, the existence of the cylindrical member can impart moderate rigidity, so that it is possible to provide a light irradiation medical device that is small in diameter and has good operability.
[12] In the step of forming a resin tube by connecting a second resin tube to the proximal portion of the first resin tube, and forming a reduced-diameter portion whose lumen narrows toward the distal side of the resin tube. a step of inserting a core material having a first region with a predetermined outer diameter and a second region with a larger outer diameter than the first region into the lumen of the resin tube; heat-shrinking a resin tube to form a reduced-diameter portion with a narrower lumen toward the distal side of the resin tube; and removing a core material from the lumen of the resin tube [11]. 2. A method for manufacturing the photoirradiation medical device according to 1.
[13] In the step of inserting the core material into the lumen of the resin tube, the first region of the core material is arranged in the lumen of the first resin tube, and the second region of the core material is arranged in the lumen of the second resin tube. The method for manufacturing the photoirradiation medical device according to [12].
[14] The method for manufacturing a light irradiation medical device according to any one of [11] to [13], wherein the inner surface of the first resin tube and the outer peripheral surface of the light diffusion portion are in contact with each other.
[15] The method for manufacturing a light irradiation medical device according to any one of [11] to [14], wherein the inner surface of the second resin tube and the outer peripheral surface of the optical fiber are not in contact with each other.
[16] The core material has, in the second region, a tapered portion extending from the end of the first region and decreasing in outer diameter toward the distal side [8] to [10], [12 ] or [13].
[17] Any one of [8] to [16], further comprising a step of inserting the optical fiber into the lumen of the tubular member before arranging the tubular member and the optical fiber into the lumen of the resin tube. 2. A method for manufacturing the photoirradiation medical device according to 1.
[18] The method for manufacturing a light irradiation medical device according to [17], wherein the cylindrical member and the optical fiber are fixed with the optical fiber inserted into the lumen of the cylindrical member.
[19] The method for manufacturing a photoirradiation medical device according to any one of [8] to [18], wherein the cylindrical member has a coil portion in which a wire is spirally wound.
[20] The method for manufacturing a light irradiation medical device according to [19], wherein the wire is in contact with the inner surface of the resin tube over its entire length.

The light irradiation medical device and the method for manufacturing the light irradiation medical device provide a light irradiation medical device in which the diameter of the resin tube itself can be easily reduced. As a result, it is easy to insert into a thin tube, the optical fiber can be brought closer to the affected area, and the treatment efficiency can be improved. In addition, since the presence of the coil member or the cylindrical member can impart appropriate rigidity, it is possible to improve operability while reducing the diameter.

1 is a cross-sectional view (partial side view) of a light irradiation medical device according to an embodiment of the present invention; FIG. FIG. 2 is a cross-sectional end view of the light irradiation medical device shown in FIG. 1 taken along line II-II. 1. It is sectional drawing (partial side view) which shows the modification of the light irradiation medical device shown in FIG. 2 is an enlarged cross-sectional view of the distal side of the optical fiber shown in FIG. 1; FIG. FIG. 2 is a cross-sectional view showing a modification of the optical fiber shown in FIG. 1; 3 is a cross-sectional view showing another modification of the optical fiber shown in FIG. 1; FIG. 3 is a cross-sectional view showing another modification of the optical fiber shown in FIG. 1; FIG. FIG. 10 is a cross-sectional view (partial side view) enlarging the distal side of a light irradiation medical device according to another embodiment of the present invention. FIG. 4 is a side view showing an example of members prepared when manufacturing the light irradiation medical device according to one embodiment of the present invention. FIG. 4 is a side view showing an example of a core material prepared when manufacturing the light irradiation medical device according to one embodiment of the present invention. FIG. 4 is a side view showing a modification of the core material prepared when manufacturing the light irradiation medical device according to one embodiment of the present invention. FIG. 4 is a side view showing a modification of members prepared when manufacturing the light irradiation medical device according to one embodiment of the present invention. 1. It is sectional drawing (partial side view) which shows the modification of the light irradiation medical device shown in FIG.

Hereinafter, the present invention will be described in detail with reference to the drawings, but the present invention is not limited to the illustrated examples, and can be implemented with appropriate modifications within the scope that can conform to the gist of the above and later descriptions. All of them are included in the technical scope of the present invention. In each drawing, hatching, symbols, etc. may be omitted for the sake of convenience. In such cases, the specification and other drawings shall be referred to. In addition, the dimensions of various parts in the drawings may differ from the actual dimensions, since priority is given to aid understanding of the features of the present invention.

One embodiment of the light irradiation medical device of the present invention includes a resin tube having a reduced diameter portion that narrows the lumen toward the distal side; an optical fiber extending in the longitudinal direction of the resin tube in a predetermined section and having a light diffusing portion that emits light radially outward of the resin tube; and a coil member in which a wire is helically wound around the optical fiber, and the distal end of the coil member and the inner surface of the reduced diameter portion are in contact with each other. In the light irradiation medical device, the diameter of the resin tube itself can be easily reduced. As a result, it is easy to insert into a thin tube, the optical fiber can be brought closer to the affected area, and the treatment efficiency can be improved. In addition, since the presence of the coil member can impart appropriate rigidity, the operability can be improved.

A photoirradiation medical device is used in PDT and photoablation to irradiate light of a specific wavelength to the treatment area, which is the target tissue such as cancer cells, in a body lumen such as a blood vessel or digestive tract. The light irradiation medical device may be delivered to the treatment site alone, or may be used together with a delivery catheter or endoscope. In treatment using an endoscope, a light irradiation medical device is placed inside the body through a forceps channel of the endoscope and delivered to a treatment site.

The basic configuration of the device will be described with reference to FIGS. 1 to 8. FIG. 1 is a cross-sectional view (partial side view) of a light irradiation medical device according to one embodiment of the present invention. FIG. 2 is an end view of the light irradiation medical device shown in FIG. 1 taken along line II-II. FIG. 3 is a cross-sectional view (partial side view) showing a modification of the light irradiation medical device shown in FIG. FIG. 4 is an enlarged cross-sectional view of the distal side of the optical fiber shown in FIG. FIG. 5 is a cross-sectional view showing a modification of the optical fiber shown in FIG. FIG. 6 is a cross-sectional view showing another modification of the optical fiber shown in FIG. FIG. 7 is a cross-sectional view showing another modification of the optical fiber shown in FIG. FIG. 8 is a cross-sectional view (partial side view) enlarging the distal side of a light irradiation medical device according to another embodiment of the present invention. The light irradiation medical device 1 has a resin tube 10 , an optical fiber 20 and a coil member 40 . In the following, the light irradiation medical device may be simply referred to as the device.

The device 1 has a resin tube 10. The resin tube 10 has a longitudinal direction x, a radial direction, and a circumferential direction p. The resin tube 10 preferably has a distal end and a proximal end in the longitudinal direction x and has a lumen 11 extending in the longitudinal direction x. The resin tube 10 may have only one lumen 11 or may have a plurality of lumens 11 . The resin tube 10 has a cylindrical shape for arranging the optical fiber 20 and the coil member 40 in its lumen 11 . The resin tube 10 preferably has a tubular shape with only one lumen 11 . Since the resin tube 10 is inserted into the body, it preferably has flexibility. Resin tube 10 has an inner surface 12 and an outer surface 13 .

The resin tube 10 can be manufactured by extrusion molding, for example. The resin tube 10 may be composed of a single layer or multiple layers. A part of the resin tube 10 in the longitudinal direction x or the circumferential direction p may be composed of a single layer, and the other part may be composed of a plurality of layers.

The resin tube 10 is made of, for example, polyolefin resin (eg, polyethylene or polypropylene), polyamide resin (eg, nylon), polyester resin (eg, PET), aromatic polyether ketone resin (eg, PEEK), polyether polyamide resin, It can be made of synthetic resin such as polyurethane resin, polyimide resin, fluorine resin (for example, PTFE, PFA, ETFE). These may be used individually by 1 type, and may be used in combination of 2 or more types. It is preferable that at least a portion of the resin tube 10 that overlaps with the light diffusion portion 21 described later is made of a resin having light transmittance. At least a portion of the resin tube 10 that overlaps the light diffusion portion 21 may be made of a transparent resin.

As shown in FIG. 1, the resin tube 10 has a reduced diameter portion 14 in which the lumen 11 narrows toward the distal side. As a result, the diameter of the resin tube 10 can be easily reduced, so that the resin tube 10 can be easily inserted into a thin tube, the optical fiber 20 can be brought closer to the affected area, and the treatment efficiency can be improved.

It is preferable that the outer diameter of the reduced diameter portion 14 narrows toward the distal side. As a result, the diameter of the resin tube 10 can be easily reduced, so that it can be easily inserted into a thin tube, the optical fiber 20 can be easily brought closer to the affected area, and the treatment efficiency can be easily improved.

A distal tip 15 may be attached to the distal end of the resin tube 10 as shown in FIG. Damage to living tissue by the distal end of the resin tube 10 can be avoided. Examples of the shape of the distal tip 15 include a cylindrical shape, an oval cylindrical shape, a hemispherical shape, an oval spherical shape, a truncated pyramid shape, a truncated cone shape, a long truncated cone shape, a rounded truncated pyramid shape, or a combination thereof. can be done.

The device 1 is arranged in the lumen 11 of the resin tube 10, extends in the longitudinal direction x of the resin tube 10 in a predetermined section of the distal portion, and extends outward in the radial direction of the resin tube 10. It has an optical fiber 20 having a light diffusing portion 21 for emitting light. The optical fiber 20 is a transmission line that transmits optical signals to the target tissue. As shown in FIG. 1, the optical fiber 20 is arranged in the lumen 11 of the resin tube 10. As shown in FIG. In FIG. 1, the proximal end of the optical fiber 20 extends proximally from a handle 60, which will be described later. The proximal end of optical fiber 20 is connected to a light source such as a semiconductor laser. The light diffusing portion 21 functions as a light emitting area capable of emitting light radially outward. The light diffusion portion 21 is arranged to extend in the longitudinal direction x and the circumferential direction p of the resin tube 10 . The light diffusing portion 21 has an outer peripheral surface 23 . An outer peripheral surface 23 of the light diffusion portion 21 faces the inner surface 12 side of the resin tube 10 .

The device 1 is inserted through the endoscope to the position where the target tissue is in the body cavity. At this time, the target tissue is positioned radially outward of the outer surface 13 of the resin tube 10 . The light emitted from the light diffusing portion 21 passes through at least a portion of the resin tube 10 that overlaps the light diffusing portion 21 , so that the light reaches the target tissue around the device 1 .

As described above, from the light diffusion portion 21, it is preferable that light is emitted at least outward in the radial direction of the resin tube 10, and from the light diffusion portion 21, the entire circumferential direction p of the resin tube 10 It is preferable that the light is emitted outward in the radial direction of the resin tube 10 over the entire area. From the light diffusing portion 21 , light may be further emitted toward the distal direction of the resin tube 10 , that is, toward the front.

The light diffusing part 21 is not a diffusing member separate from the optical fiber 20 (for example, a diffusion plate or a prism), but a part forming part of the optical fiber 20 . Optical fiber 20 has a core and a clad. The clad is arranged on the outer circumference of the core and covers a part of the radially outer side of the core. The light diffusion part 21 has (i) a mode in which only the core is arranged, (ii) a mode in which the core and the clad are arranged, or (iii) a part in which only the core is arranged and the other part in which the core and the clad are arranged. is preferably configured from any of the aspects in which is arranged. A covering material for protection may be arranged outside the clad in the radial direction, but it is preferable that the light diffusing portion 21 is not arranged with members other than the core and the clad.

The materials that make up the core and clad are not particularly limited, and glass such as plastic, quartz glass, and fluoride glass can be used.

At least in the portion of the resin tube 10 that overlaps the light diffusion portion 21, the resin constituting the resin tube 10 contains inorganic particles such as titanium oxide, barium sulfate, and calcium carbonate, and organic particles such as crosslinked acrylic particles and crosslinked styrene particles. Particle light diffusing materials can be added. Light emitted from the light diffusing portion 21 is more easily diffused by the resin tube 10 .

The light diffusion part 21 is preferably arranged on the most distal side of the optical fiber 20 . This makes it easier to form the light diffusing portion 21 and increases the flexibility of the distal end portion of the optical fiber 20 .

The length of the light diffusion portion 21 in the longitudinal direction x may be set to 1/50 or more, 1/45 or more, or 1/30 or more of the total length of the optical fiber 20 . By setting such a length, it becomes easy to irradiate the entire target tissue with a single irradiation. Also, the length of the light diffusing portion 21 in the longitudinal axis direction x may be set to 1/20 or less, 1/25 or less, or 1/30 or less of the total length of the optical fiber 20 . By setting such a length, it is possible to prevent irradiation of non-target tissues.

The light diffusing portion 21 may be arranged only in a part of the resin tube 10 in the circumferential direction p, but as shown in FIG. It is preferable that Since a wide range in the circumferential direction p can be irradiated at once, efficiency of the procedure can be improved.

As shown in FIG. 2, the inner surface 12 of the resin tube 10 and the outer peripheral surface 23 of the light diffusion portion 21 may be in contact with each other. As a result, the diameter of the light diffusing portion 21 can be easily reduced, so that the device 1 can be easily made such that the light diffusing portion 21 can be brought closer to the affected area. As a result, it is possible to easily irradiate even the smallest details with light, and the treatment efficiency can be improved. In addition, since the inner surface 12 of the resin tube 10 and the outer peripheral surface 23 of the light diffusion portion 21 are in contact with each other, there is no gap between the light diffusion portion 21 and the resin tube 10 at that location, so that the light diffusion portion 21 is Since it is reinforced and strength can be imparted to the light diffusing portion 21, the damage resistance of the light diffusing portion 21 can be easily improved. In addition, the inner surface 12 of the resin tube 10 and the outer peripheral surface 23 of the light diffusion portion 21 may not be in contact with each other.

As shown in FIG. 1, the device 1 has a coil member 40 which is arranged in the lumen 11 of the resin tube 10 and has a wire 42 spirally wound around the optical fiber 20 . It is preferable that the entire coil member 40 is arranged in the lumen 11 of the resin tube 10 in the longitudinal direction x. Due to the presence of the coil member 40 , the inner surface 12 of the resin tube 10 on the proximal side of the reduced diameter portion 14 does not have to be in contact with the outer peripheral surface 23 of the optical fiber 20 .

The wire rod 42 has a distal end and a proximal end in its longitudinal direction. The wire 42 may be composed of a single linear member from the distal end to the proximal end, or the wire 42 may be composed of a plurality of linear members connected to each other in the longitudinal direction thereof.

The cross-sectional shape of the wire rod 42 perpendicular to the longitudinal axis direction may be circular, oval, polygonal, or a combination thereof. The oval shape includes an elliptical shape, an egg shape, and a rounded rectangular shape. The same applies to other descriptions in this specification.

The wire diameter (thickness) of the wire 42 constituting the coil member 40 and the number of turns of the wire 42 are not particularly limited. The axial length of the coil member 40 may be larger or smaller than the maximum outer diameter of the coil member 40 .

The outer diameter of the coil member 40 may be constant in the longitudinal axis direction x of the resin tube 10, or the outer diameter of the coil member 40 may vary depending on the position in the longitudinal axis direction x. For example, when the coil member 40 is divided into a distal portion and a proximal portion in the longitudinal direction x, the average outer diameter of the distal portion of the coil member 40 is equal to the average outer diameter of the proximal portion of the coil member 40. may be smaller than

The inner diameter of the coil member 40 may be constant in the longitudinal axis direction x of the resin tube 10, or the inner diameter of the coil member 40 may vary depending on the position in the longitudinal axis direction x. For example, when the coil member 40 is divided into a distal portion and a proximal portion in the longitudinal direction x, the average inner diameter of the distal portion of the coil member 40 is larger than the average inner diameter of the proximal portion of the coil member 40. It can be small.

The coil member 40 is preferably made of a material having a higher reflectance than the resin tube 10. This configuration facilitates diffusion of the reflected light on the inner surface of the coil member 40 . Here, the reflectance refers to the reflectance of light emitted from the light diffusing portion 21, and the unit is %. The reflectance can be measured using a reflectance measurement system OP-RF-VIS-GT50 manufactured by Ocean Photonics.

The coil member 40 is preferably constructed of metal, and may be, for example, radiopaque metals such as gold, silver, platinum, palladium, tungsten, tantalum, iridium and alloys thereof, stainless steel, Ni—Ti alloys. and other superelastic alloys.

A part of the coil member 40 may be made of resin. The coil member 40 may have a coil member main body and a reflective layer arranged on the inner surface of the coil member main body. The light from the light diffusing portion 21 can be reflected by the reflective layer regardless of the material of the coil member main body. For example, a coil body or a resin tube around which a resin wire is wound may be the coil member main body. The reflective layer may be provided by applying a coating agent containing a reflective material to the inner surface of the coil member body, and the reflective material is applied to the inner surface of the coil member body by a method such as vapor deposition, sputtering, electroplating, or chemical plating. It may be arranged by adhering. Note that the reflective layer may be a metal thin film. Reflective materials include, for example, aluminum, gold, silver, copper, tin, titanium dioxide, tantalum pentoxide, aluminum oxide, silicon dioxide, magnesium fluoride, or combinations thereof. When the coil member 40 has a reflective layer, at least one of the materials listed as the constituent materials of the resin tube 10 can be used for the coil member main body.

Although the pitch P of the coil member 40 is not particularly limited, the coil member 40 preferably has a pitch P equal to or greater than the wire diameter of the wire rod 42, and may have a pitch of 1.1 times or more. It may have a pitch of .2 or more. Also, the coil member 40 may have a pitch of 3.0 times or less the wire diameter of the wire 42, or may have a pitch of 2.5 times or less. The pitch P is the distance between the central axes of two adjacent wires 42 forming the coil member 40 in the axial direction, as shown in FIG. The pitch P of the coil members 40 may be constant in the axial direction, or may vary depending on the position in the axial direction. In addition, all the pitches P existing in the coil member 40 may be within the above range, or a part of the pitches may be within the above range. By having the pitch P as described above, it is possible to impart flexibility and moderate rigidity, and it is possible to easily improve the operability.

The coil member 40 may have the same pitch P as the wire diameter of the wire 42 . Such coils are commonly referred to as tight wound coils. A tight-wound coil is preferable because there is no gap between two adjacent wire rods 42 and light is less likely to leak from the coil member 40 . It is also preferable when the coil member 40 is used as a marker.

When the wire diameter of the wire 42 changes in its longitudinal axis direction (for example, when there is a large diameter portion and a small diameter portion with a smaller wire diameter than the large diameter portion), the coil member 40 may have a pitch P smaller than the wire diameter of the

The coil member 40 may be a single-layer winding coil, a multi-layer winding coil, or a combination thereof. For example, FIG. 1 shows an example in which the coil member 40 is a single-layer wound coil.

As shown in FIG. 3, the coil member 40 includes a first coil portion 40a that is wound in a single layer and a second coil portion that is positioned proximal to the first coil portion 40a and is wound in multiple layers. 40b. Torque can be easily transmitted to the distal side by the second coil portion 40b wound in multiple layers, and the operability of the device 1 can be enhanced. In the coil member 40, the second coil portion 40b wound in multiple layers may be positioned further to the distal side than the first coil portion 40a wound in a single layer.

As shown in FIG. 1, the wire rod 42 of the coil member 40 may be in contact with the inner surface 12 of the resin tube 10. The wire 42 may be in contact with the inner surface 12 of the resin tube 10 over its entire length. As a result, the position of the optical fiber 20 in the radial direction of the resin tube 10 can be easily stabilized, so that the operability can be easily improved. Note that the wire 42 of the coil member 40 does not have to be in contact with the inner surface 12 of the resin tube 10 .

As shown in FIG. 1, the distal end portion of the coil member 40 of the device 1 and the inner surface 140 of the reduced diameter portion 14 are in contact. More preferably, the distal end 401 of the coil member 40 and the inner surface 140 of the reduced diameter portion 14 are in contact. With this configuration, moderate rigidity can be imparted, so that it is possible to provide the light irradiation medical device 1 with good operability while having a small diameter.

The distal end portion of the coil member 40 and the inner surface 140 of the reduced diameter portion 14 may be fixed. The coil member 40 may be directly fixed to the reduced diameter portion 14, or may be indirectly fixed via another member. The method of fixing the coil member 40 and the reduced diameter portion 14 is not particularly limited, but may be, for example, welding, welding, crimping such as caulking, bonding with an adhesive, engagement, connection, binding, ligature, or other physical fixing. methods, or combinations thereof. Note that the distal end portion of the coil member 40 and the inner surface 140 of the reduced diameter portion 14 may not be fixed.

As shown in FIG. 1 , the light diffusing portion 21 of the optical fiber 20 may be arranged distally of the distal end 401 of the coil member 40 . Although only part of the light diffusing portion 21 may be arranged distally of the distal end 401 of the coil member 40 , the entire light diffusing portion 21 is distal of the distal end 401 of the coil member 40 . It is more preferable to be arranged on the side. As a result, the diameter of the light diffusing portion 21 can be easily reduced, so that the device 1 can bring the light diffusing portion 21 closer to the affected area. This can improve treatment efficiency.

The device 1 may further have a handle 60 connected to the proximal portion of the resin tube 10. In FIG. 1, the proximal portion of resin tube 10 is connected to handle 60 . By holding the handle 60 by the operator, the device 1 can be easily operated. The handle 60 extends, for example, in the longitudinal direction x. Handle 60 may be constructed from one or more members. In FIG. 1, the handle 60 has a hollow portion 61 extending in the longitudinal direction x. The handle 60 may have, for example, a tubular shape. In FIG. 1 , the resin tube 10 , the optical fiber 20 and the coil member 40 are inserted through the hollow portion 61 .

Although the material of the handle 60 is not particularly limited, for example, polyolefin resins such as polypropylene (PP) and polyethylene (PE), polyester resins such as polyethylene terephthalate (PET), polycarbonate resins, ABS resins, and synthetic resins such as polyurethane resins are used. be able to.

The proximal portion of the coil member 40 may be fixed to the handle 60, or the proximal end portion of the coil member 40 may be fixed to the handle 60. The coil member 40 may be directly fixed to the handle 60, or may be indirectly fixed via another member. The method of fixing the coil member 40 and the handle 60 is not particularly limited. Or a combination thereof can be mentioned. As a result, torque can be easily transmitted, and operability can be easily improved. Note that the coil member 40 does not have to be fixed to the handle 60 .

The outer peripheral surface 23 of the optical fiber 20 and the inner peripheral surface of the coil member 40 may be fixed. The coil member 40 may be directly fixed to the optical fiber 20, or may be indirectly fixed via another member. The method of fixing the coil member 40 and the optical fiber 20 is not particularly limited. Or a combination thereof can be mentioned. Note that the outer peripheral surface 23 of the optical fiber 20 and the inner peripheral surface of the coil member 40 may not be fixed.

A configuration example of the optical fiber 20 will be described with reference to FIGS. 4 to 7. FIG. 4-7, the optical fiber 20 has a core 25 extending in the longitudinal direction x, and the optical fiber 20 has a first clad 26 disposed around the core 25. It has one section 31 . In the first section 31, the light is likely to be totally reflected at the boundary between the core 25 and the first clad 26. Therefore, in the first section 31, the light is confined within the core 25 and propagates to the distal side of the optical fiber 20. .

It is preferable that one core 25 is arranged in one first clad 26 in the first section 31 . In the first section 31, the optical fiber 20 can be rephrased as a single-core optical fiber.

In order to prevent the profile of the optical fiber 20 from increasing, the first clad 26 may be positioned radially outwardly of the optical fiber 20 in the first section 31 . That is, the first section 31 does not need to be provided with other members such as a covering material.

Although not shown, the first section 31 of the optical fiber 20 may be provided with a coating material around the outer periphery of the first clad 26 . It is possible to protect the outside of the first section 31 , and it is also possible to suppress light leakage and emission to the outside in the first section 31 . The coating material may be a coating layer arranged on the outer peripheral surface of the first clad 26 or a sheath enclosing the first clad 26 . The covering material can be made of a resin such as an ultraviolet curable resin.

In FIG. 4 , the optical fiber 20 has a second section 32 having a second clad 27 disposed on the outer periphery of the core 25 and having a larger outer surface roughness than the first clad 26 in the light diffusion portion 21 . It shows an embodiment having The second section 32 is positioned more distally than the first section 31 . By making the clad surface roughness larger in the second section 32 than in the first section 31, part of the light is confined within the core 25 and propagated to the distal side of the optical fiber 20, and the remaining light is transmitted to the second section 31. It leaks out from the clad 27 and is injected radially outward. It is preferable that the first section 31 does not emit light radially outward, or that the amount of light leakage is smaller than that of the second section 32 .

As in the first section 31 , in the second section 32 , one core 25 is preferably arranged in one second clad 27 . The first section 31 and the second section 32 may consist of one optical fiber. The first clad 26 of the first section 31 and the second clad 27 of the second section 32 may be integrally molded. The optical fiber 20 may be formed by joining the optical fiber for the first section 31 and the optical fiber for the second section 32 in the longitudinal axis direction x. The first clad 26 of the first section 31 and the second clad 27 of the second section 32 may be separately formed and then joined together.

In the second section 32, it is preferable that the second clad 27 is located on the outermost side of the optical fiber 20 in the radial direction. That is, in the second section 32, it is preferable that no member (for example, a covering material) other than the core 25 and the second clad 27 is arranged. With this configuration, light can be emitted outward in the radial direction of the resin tube 10 from the second section 32 .

The surface roughness of the outer peripheral surface of the second clad 27 in the second section 32 is greater than the surface roughness of the outer peripheral surface of the first clad 26 in the first section 31 . Here, the surface roughness is the arithmetic mean roughness Ra between the reference lengths of the roughness curve in the longitudinal axis direction of the outer peripheral surface of the optical fiber 20 . The reference length may be set according to the magnification of the laser microscope used, and is, for example, 200 μm. The above arithmetic mean roughness Ra corresponds to the arithmetic mean roughness Ra specified in JIS B 0601 (2001) and is measured according to JIS B 0633 (2001). For the measurement, a measuring machine specified in JIS B 0651 (2001) (for example, a laser microscope VK-X3000 manufactured by Keyence Corporation) is used.

The average value of the surface roughness of the outer peripheral surface of the second clad 27 in the second section 32 is preferably larger than the average value of the surface roughness of the outer peripheral surface of the first clad 26 in the first section 31 . In the first section 31 , light is likely to be confined within the core 25 , and in the second section 32 , light is likely to be emitted radially outward from the second clad 27 . As a result, the light emission intensity distribution of the light diffusing portion 21 is easily made uniform in the longitudinal direction x. The average value of the surface roughness is the average value of the surface roughness values of 10 or more measurement points set so as to be aligned in the longitudinal axis direction x in the section to be measured (for example, the first section 31). .

As shown in FIG. 4, when the second section 32 is divided into a distal portion 323 and a proximal portion 324 in the longitudinal direction x, the surface roughness of the outer peripheral surface of the second clad 27 in the proximal portion 324 is The average value is preferably smaller than the average surface roughness of the outer peripheral surface of the second clad 27 in the distal portion 323 . With this configuration, the proximal portion 324 enhances the effect of confining light within the core 25 more than the distal portion 323, while the distal portion 323 facilitates the radially outward emission of light from the second clad 27. Therefore, the emission intensity distribution of the second section 32 is easily uniformed in the longitudinal direction x.

The second section 32 is preferably shorter than the first section 31 in the longitudinal direction x. It becomes easier to form the light diffusing portion 21, and the flexibility of the distal end portion of the optical fiber 20 can also be increased. The length of the second section 32 in the longitudinal direction x can be set to 1/20 or less, 1/25 or less, or 1/30 or less of the length of the first section 31 . Also, the length of the second section 32 in the longitudinal axis direction x may be set to 1/50 or more, 1/45 or more, or 1/30 or more of the length of the first section 31. good.

As can be understood from FIG. 4, the average thickness of the second clad 27 in the second section 32 is preferably smaller than the average thickness of the first clad 26 in the first section 31. By adjusting the thickness of the clad in this way, light is more likely to be confined in the core 25 in the first section 31, and light is more likely to be emitted radially outward from the second clad 27 in the second section 32. . Here, the clad thickness can be measured using a laser microscope VK-X3000 manufactured by Keyence Corporation.

As shown in FIGS. 5 and 6, when the optical fiber 20 has the first section 31, the optical fiber 20 has no cladding in the light diffusing portion 21 and is located distal to the first section 31. You may have the 3rd area 33 which is carrying out. Since there is no clad in the third section 33, the light from the core 25 is emitted radially outward.

In the third section 33, it is preferable that no clad exists in at least a part of the core 25 in the circumferential direction, and more preferably, no clad exists in the entire circumferential direction of the core 25.

In the third section 33, it is preferable that the core 25 is positioned radially outermost in the optical fiber 20. That is, in the third section 33, not only the clad but also any member other than the core 25 (for example, a covering material) is preferably not arranged.

In the longitudinal direction x, the outer diameter of the core 25 in the third section 33 may be a constant value, or the outer diameter of the core 25 may be a different value depending on the position in the longitudinal direction x.

As shown in FIGS. 5 and 6, the distal end of the third section 33 is preferably at the same position as the distal end of the core 25 in the longitudinal direction x. It becomes easier to form the third section 33, and the flexibility at the distal end of the optical fiber 20 can also be increased.

The surface roughness of the outer peripheral surface of the core 25 in the third section 33 is preferably larger than the surface roughness of the outer peripheral surface of the first clad 26 in the first section 31 . Light is likely to be confined within the core 25 in the first section 31 , and light is likely to be emitted radially outward from the core 25 in the third section 33 .

At least one of the second section 32 and the third section 33 is preferably arranged in the light diffusion section 21, and both the second section 32 and the third section 33 may be arranged. As shown in FIG. 5, it is preferable that a second section 32 and a third section 33 are arranged in order from the proximal side to the distal side of the light diffusing section 21 . With this configuration, the light emission intensity distribution of the light diffusing portion 21 can be easily uniformed in the longitudinal direction x. In order to enhance this effect, it is preferable that the first section 31, the second section 32, and the third section 33 are adjacent to each other in the longitudinal direction x. More specifically, the first section 31 and the second section 32 are adjacent to each other, and the second section 32 and the third section 33 are preferably adjacent to each other.

When the optical fiber 20 has a second section 32 and a third section 33, it is preferable that the third section 33 is shorter than the second section 32 in the longitudinal direction x as shown in FIG. With this configuration, it becomes easier to uniform the emission intensity distribution of the entire light diffusing portion 21 in the longitudinal direction x. A mode in which the second section 32 is shorter than the third section 33 in the longitudinal direction x is also allowed.

The length of the third section 33 in the longitudinal direction x is preferably 20% or less of the total length of the second section 32 and the third section 33, and is preferably 18% or less. More preferably, the size is 15% or less. In addition, the length of the third section 33 in the longitudinal direction x may be 5% or more, 8% or more, or 10% or more of the total length of the second section 32 and the third section 33. . This configuration makes it easier to uniformize the light emission intensity distribution of the light diffusion portion 21 in the longitudinal direction x.

The average value of the surface roughness of the outer peripheral surface of the second clad 27 in the second section 32 is preferably smaller than the average value of the surface roughness of the outer peripheral surface of the core 25 in the third section 33 . This configuration makes it easier to uniformize the emission intensity distribution in the longitudinal axis direction x in each of the second section 32 and the third section 33 .

As shown in FIG. 4, the optical fiber 20 may have only the second section 32 in the light diffusing portion 21 . That is, the optical fiber 20 does not have to have the third section 33 in the light diffusing portion 21 . Even with the configuration having only the second section 32, the light emission intensity distribution of the light diffusing portion 21 in the longitudinal axis direction x can be made uniform. Since the core 25 is not exposed, it also has the effect of preventing damage to the optical fiber 20 due to bending of the device 1 during the procedure.

When the optical fiber 20 has only the second section 32 in the light diffusing portion 21, the distal end of the second section 32 is preferably at the same position as the distal end of the core 25 in the longitudinal direction x. .

As shown in FIG. 6, the optical fiber 20 may have only the third section 33 in the light diffusing portion 21 . That is, the optical fiber 20 does not have to have the second section 32 in the light diffusing portion 21 . Even with the configuration having only the third section 33, the light emission intensity distribution of the light diffusing portion 21 in the longitudinal axis direction x can be made uniform.

The second section 32 and the third section 33 can be formed by removing the clad by etching or polishing. In order to adjust the surface roughness of the second section 32 and the third section 33, the outer peripheral surface of the second clad 27 and the outer peripheral surface of the core 25 of the third section 33 may be uneven. The unevenness can be formed by mechanically or chemically roughening the surface of the core 25 of the second clad 27 or the third section 33 . Examples of methods for roughening the surface include etching, blasting, a method using a scribe, a wire brush, or sandpaper.

As shown in FIG. 7, it is preferable that the distal end surface of the optical fiber 20 is provided with a reflector 200 . The reflector 200 is, for example, a mirror arranged so that the reflecting surface faces the proximal side. This configuration makes it easier for the reflected light to diffuse outward in the radial direction of the resin tube 10 .

The surface of the reflector 200 is preferably made of aluminum, gold, silver, copper, tin, titanium dioxide, tantalum pentoxide, aluminum oxide, silicon dioxide, or magnesium fluoride.

The light diffusing portion 21 should emit the first light beam for treatment. The first light beam is preferably laser light with a wavelength suitable for phototherapy such as PDT and PIT for irradiating internal tissue. In addition to the first beam, a second targeting beam may be emitted. The second light beam is a light beam emitted to grasp the treatment site before the first light beam is emitted, and preferably has a lower radiant energy than the first light beam.

The outer diameter of the core 25 at the distal end of the optical fiber 20 may decrease toward the distal end. As shown in FIG. 8 , the outer diameter of the core 25 may decrease toward the distal end side over the entire longitudinal axis direction x in the third section 33 .

As shown in FIG. 8 , the device 1 further includes a distal side coil member 50 that is in contact with the outer peripheral surface of the core 25 and that extends in the longitudinal direction x of the resin tube 10 . good too. The distal side coil member 50 is arranged distally of the coil member 40 . As shown in FIG. 8 , the distal coil member 50 may contact the outer peripheral surface of the third section 33 .

As shown in FIG. 8, the distal coil member 50 is composed of a wire 52 having an outer diameter equal to or less than the thickness of the first clad 26 of the first section 31. It is preferable that Moreover, it is preferable that the wire rod 52 is arranged so as to surround the core 25 . As a result, the light emitted from the third section 33 can be reflected on the inner surface of the distal coil member 50 while the distal end portion of the device 1 is made thinner, so that the reflected light can be reflected by the optical fiber 20 . It becomes easy to diffuse in various directions from the part not covered with the distal side coil member 50 among them. As for the material forming the distal coil member 50, the description of the coil member 40 can be referred to.

Next, with reference to FIGS. 9 to 13, a method for manufacturing a light irradiation medical device according to an embodiment of the present invention will be described. FIG. 9 is a side view showing an example of members prepared when manufacturing the photoirradiation medical device according to one embodiment of the present invention. FIG. 10 is a side view showing an example of a core material prepared when manufacturing the light irradiation medical device according to one embodiment of the present invention. FIG. 11 is a side view showing a modification of the core material prepared when manufacturing the light irradiation medical device according to one embodiment of the present invention. FIG. 12 is a side view showing a modification of members prepared when manufacturing the light irradiation medical device according to one embodiment of the present invention. 13 is a cross-sectional view (partial side view) showing a modification of the light irradiation medical device shown in FIG. 1. FIG. In addition, in the description of the apparatus 1, the same reference numerals are given to the members and the like that have already been described, and the description thereof will be omitted.

One embodiment of the method for manufacturing a light irradiation medical device of the present invention includes a resin tube, and a resin tube extending in the longitudinal axis direction x of the resin tube in a predetermined section of the distal portion and extending outward in the radial direction of the resin tube. an optical fiber having a light diffusing portion that emits light through a cylindrical member; and a core member having a first region having a predetermined outer diameter and a second region having an outer diameter larger than that of the first region. preparing, inserting a core material into the lumen of the resin tube, heating the resin tube to heat shrink the resin tube, and reducing the diameter of the resin tube by narrowing the lumen toward the distal side. removing the core material from the lumen of the resin tube; placing the cylindrical member and the optical fiber in the lumen of the resin tube, and the distal end of the cylindrical member and the inner surface of the reduced diameter portion and a step of contacting. According to the manufacturing method of the above-described light irradiation medical device, the resin tube itself can be easily made thin, the light irradiation medical device 1 can be easily inserted into a thin tube, and the optical fiber can be brought closer to the affected area. This can improve treatment efficiency. In addition, the presence of the cylindrical member can impart appropriate rigidity, so that the light irradiation medical device 1 with good operability can be provided while having a small diameter.

First, as shown in FIGS. 9 and 10, a resin tube 1010, an optical fiber 20 having a light diffusing portion 21, a cylindrical member 1050, a first region 1060a having a predetermined outer diameter, and a A core material 1060 having a second region 1060b with a large outer diameter is prepared. Note that the resin tube 1010 prepared here refers to the resin tube before the diameter-reduced portion described above is formed.

The tubular member 1050 is a tubular member that partially covers the optical fiber 20 . Tubular member 1050 preferably has one lumen. The shape of the cylindrical member 1050 is not particularly limited, but may be cylindrical, elliptical, or polygonal. The axial length of tubular member 1050 may be larger or smaller than the maximum outer diameter of tubular member 1050 .

The core material 1060 is a member having a first region 1060a with a predetermined outer diameter and a second region 1060b with a larger outer diameter than the first region 1060a. The shape of the core material 1060 is preferably a cylindrical shape, an oval columnar shape, a polygonal columnar shape, or the like. The shape of the core material 1060 is not limited to the shape shown in FIG. 10. As shown in FIG. It may be a shape having a tapered portion in which .DELTA.

A core material 1060 is inserted into the lumen 1011 of the prepared resin tube 1010, and the resin tube 1010 is heated to thermally shrink the resin tube 1010, thereby reducing the lumen narrowing toward the distal side with respect to the resin tube. forming a diameter; The resin tube having the reduced diameter portion formed in this way corresponds to the resin tube 10 shown in FIG. 1 and the like.

Before heating the resin tube 1010 to heat shrink the resin tube 1010, there may be a step of inserting the resin tube 1010 into the lumen of the heat shrink tube. If such a step is included, it is preferable to apply heat from the outside of the heat-shrinkable tube to heat-shrink the resin tube 1010 .

After heat shrinking, the core material 1060 is taken out from the lumen 11 of the resin tube 10, and the tubular member 1050 and the optical fiber 20 are arranged in the lumen 11 of the resin tube 10. The tubular member 1050 is preferably formed to extend in the longitudinal direction x of the resin tube 10 . At this time, the distal end portion of the cylindrical member 1050 and the inner surface 140 of the reduced diameter portion 14 are brought into contact with each other. The distal end 1051 of the tubular member 1050 and the inner surface 140 of the reduced diameter portion 14 may be brought into contact. With this configuration, the diameter of the resin tube 10 itself can be easily reduced, the light irradiation medical device 1 can be easily inserted into a thin tube, and the optical fiber 20 can be brought closer to the affected area. This can improve treatment efficiency. In addition, due to the presence of the cylindrical member 1050, it is possible to impart moderate rigidity, so that it is possible to provide the light irradiation medical device 1 with good operability while having a reduced diameter.

The distal end portion of the tubular member 1050 and the inner surface 140 of the reduced diameter portion 14 may be fixed. The tubular member 1050 may be directly fixed to the reduced diameter portion 14, or may be indirectly fixed via another member. The method of fixing the cylindrical member 1050 and the reduced diameter portion 14 is not particularly limited, but may be, for example, welding, welding, crimping such as caulking, bonding with an adhesive, engagement, connection, binding, ligature, or other physical fixing. methods, or combinations thereof. Note that the distal end portion of the cylindrical member 1050 and the inner surface 140 of the reduced diameter portion 14 may not be fixed.

The tubular member 1050 may have a coil portion in which a wire is spirally wound. The cylindrical member 1050 may be the coil member 40 described above.

When the tubular member 1050 is the coil member 40, the wire 42 may be in contact with the inner surface 12 of the resin tube 10 over its entire length. As a result, the position of the optical fiber 20 in the radial direction of the resin tube 10 can be easily stabilized, so that the operability can be easily improved. Note that the wire 42 does not have to be in contact with the inner surface 12 of the resin tube 10 .

The inner surface 12 on the distal side of the reduced diameter portion 14 of the resin tube 10 and the outer peripheral surface 23 of the light diffusion portion 21 may be in contact with each other. As a result, the diameter of the light diffusing portion 21 can be easily reduced, so that the device 1 can bring the light diffusing portion 21 closer to the affected area, and the treatment efficiency can be easily increased. In addition, the inner surface 12 of the resin tube 10 on the distal side of the reduced diameter portion 14 and the outer peripheral surface 23 of the light diffusion portion 21 may not be in contact with each other.

Due to the presence of the cylindrical member 1050 or the coil member 40, the inner surface 12 of the resin tube 10 on the proximal side of the reduced diameter portion 14 and the outer peripheral surface 23 of the optical fiber 20 may not be in contact. The presence of the tubular member 1050 or the coil member 40 makes it easier to transmit torque to the distal side, so that the operability of the device 1 can be improved.

Another embodiment of the method for manufacturing a photoirradiation medical device of the present invention includes a first resin tube, a second resin tube having an inner diameter larger than that of the first resin tube, and a predetermined section of the distal portion of the first resin tube and an optical fiber extending in the longitudinal direction of the second resin tube and having a light diffusing portion that emits light outward in the radial direction of at least one of the first resin tube and the second resin tube; connecting a second resin tube to the proximal portion of the first resin tube to form a resin tube, the diameter of which narrows the lumen distally relative to the resin tube; and placing a cylindrical member and an optical fiber in a lumen of a resin tube to bring the distal end of the cylindrical member into contact with the inner surface of the reduced diameter portion. have. According to the manufacturing method of the above-described light irradiation medical device, the resin tube itself can be easily made thin, the light irradiation medical device can be easily inserted into a thin tube, and the optical fiber can be brought closer to the affected area. As a result, treatment efficiency can be increased. In addition, the existence of the cylindrical member can impart moderate rigidity, so that it is possible to provide a light irradiation medical device that is small in diameter and has good operability.

First, as shown in FIG. 12, a first resin tube 1010a, a second resin tube 1010b having an inner diameter larger than that of the first resin tube 1010a, and a predetermined section of the distal portion of the first resin tube 1010a and the second resin tube an optical fiber 20 having a light diffusing portion 21 extending in the longitudinal direction x of the first resin tube 1010b and emitting light outward in the radial direction of at least one of the first resin tube 1010a and the second resin tube 1010b; , and a cylindrical member 1050 are prepared. Note that the first resin tube 1010a and the second resin tube 1010b prepared here refer to resin tubes in which the above-described reduced diameter portion is not formed.

A second resin tube 1010b is connected to the proximal portion of the prepared first resin tube 1010a to form one resin tube. When using the resin tube, the above-described reduced diameter portion may be formed at the joint portion when connecting the first resin tube 1010a and the second resin tube 1010b.

In addition, the above-described core material 1060 is used for the resin tube after the second resin tube 1010b is connected to the proximal portion of the first resin tube 1010a, so that the diameter of the inner lumen narrows toward the distal side. It does not matter if you form a part. For example, a resin tube is formed by connecting the second resin tube 1010b to the proximal portion of the first resin tube 1010a, and a reduced-diameter portion is formed in which the inner lumen narrows toward the distal side of the resin tube. In the step, a core member 1060 having a first region 1060a having a predetermined outer diameter and a second region 1060b having a larger outer diameter than the first region 1060a as shown in FIGS. and heating the resin tube to heat shrink the resin tube to form a reduced diameter portion that narrows the lumen distally with respect to the resin tube. good too.

In the step of inserting the core material 1060 into the lumen of the resin tube in the method for manufacturing a light irradiation medical device, the first region 1060a of the core material 1060 is arranged in the lumen 1011a of the first resin tube 1010a. The second region 1060b may be arranged in the lumen 1011b of the second resin tube 1010b.

You may have a step of inserting the resin tube into the lumen of the heat-shrinkable tube before heating and heat-shrinking the resin tube. If this step is included, it is preferable to apply heat from the outside of the heat-shrinkable tube to heat-shrink the resin tube. The resin tube having the reduced diameter portion formed in this way corresponds to the resin tube 10 shown in FIG.

A step of removing the core material 1060 from the inner cavity 11 of the resin tube 10 may be provided after the resin tube is heat-shrunk.

The cylindrical member 1050 and the optical fiber 20 are arranged in the lumen 11 of the resin tube 10 having the reduced diameter portion 14 formed therein, and the distal end portion of the cylindrical member 1050 and the inner surface 140 of the reduced diameter portion 14 are brought into contact. More preferably, the distal end 1051 of the cylindrical member 1050 and the inner surface 140 of the reduced diameter portion 14 are in contact with each other. With this configuration, the diameter of the resin tube 10 itself can be easily reduced, the light irradiation medical device 1 can be easily inserted into a thin tube, and the optical fiber 20 can be brought closer to the affected area. This can improve treatment efficiency. In addition, due to the presence of the cylindrical member 1050, it is possible to impart moderate rigidity, so that it is possible to provide the light irradiation medical device 1 with good operability while having a reduced diameter.

The distal end portion of the tubular member 1050 and the inner surface 140 of the reduced diameter portion 14 may be fixed. The cylindrical member 1050 may be directly fixed to the inner surface 140 of the reduced diameter portion 14, or may be indirectly fixed via another member. The method of fixing the cylindrical member 1050 and the inner surface 140 of the reduced diameter portion 14 is not particularly limited, but for example, physical bonding such as welding, welding, crimping such as caulking, bonding with adhesive, engagement, connection, binding, ligature, etc. methods such as fixation, or a combination thereof. Note that the distal end portion of the cylindrical member 1050 and the inner surface 140 of the reduced diameter portion 14 may not be fixed.

The method for manufacturing the light irradiation medical device further includes a step of inserting the optical fiber 20 into the lumen of the tubular member 1050 before placing the tubular member 1050 and the optical fiber 20 into the lumen 11 of the resin tube 10. good too. By inserting the optical fiber 20 into the lumen of the tubular member 1050, the optical fiber 20 can be made less likely to break.

The tubular member 1050 and the optical fiber 20 may be fixed while the optical fiber 20 is inserted into the lumen of the tubular member 1050 . The tubular member 1050 may be directly fixed to the optical fiber 20, or may be indirectly fixed via another member. The method of fixing the cylindrical member 1050 and the optical fiber 20 is not particularly limited, but for example, welding, welding, crimping such as crimping, bonding with an adhesive, engaging, connecting, binding, ligating, etc. physical fixing methods, Or a combination thereof can be mentioned. Note that the tubular member 1050 and the optical fiber 20 may not be fixed.

As shown in FIG. 13, the inner surface of the first resin tube 1010a of the resin tubes 10 and the outer peripheral surface 23 of the light diffusing portion 21 may be in contact with each other. As a result, the diameter of the resin tube 10 itself can be easily reduced, the light irradiation medical device 1 can be easily inserted into a thin tube, and the optical fiber 20 can be brought closer to the affected area. This can improve treatment efficiency.

Due to the presence of the cylindrical member 1050 or the coil member 40, the inner surface of the second resin tube 1010b of the resin tube 10 and the outer peripheral surface 23 of the optical fiber 20 do not have to be in contact. Due to the presence of the cylindrical member 1050 or the coil member 40, torque can be easily transmitted to the distal side, so that the operability of the device 1 can be easily improved.

This application claims the benefit of priority based on Japanese Patent Application No. 2021-156418 filed on September 27, 2021. The entire contents of the specification of Japanese Patent Application No. 2021-156418 filed on September 27, 2021 are incorporated herein by reference.

1: Light irradiation medical device 10: Resin tube 11: Lumen 14: Reduced diameter portion 140: Inner surface 20: Optical fiber 21: Light diffusion portion 25: Core 26: First clad 27: Second clad 31: First section 32 : second section 323: distal section 324: proximal section 33: third section 40: coil member 40a: first coil section 40b: second coil section 42: wire rod 50: distal side coil member 52: wire rod 60: Handle 200: Reflective material 1010: Resin tube 1011: Lumen 1010a: First resin tube 1010b: Second resin tube 1050: Cylindrical member 1060: Core material 1060a: First region 1060b: Second region x: Longitudinal axis direction p: circumferential direction

Claims

a resin tube having a reduced diameter portion in which the lumen narrows toward the distal side;
A light diffuser that is arranged in the lumen of the resin tube, extends in the longitudinal direction of the resin tube in a predetermined section of the distal portion, and emits light outward in the radial direction of the resin tube. an optical fiber having a portion;
a coil member arranged in the lumen of the resin tube and having a wire wound spirally around the optical fiber;
A light irradiation medical device in which the distal end portion of the coil member and the inner surface of the reduced diameter portion are in contact.
The light irradiation medical device according to claim 1, wherein the light diffusing part is arranged on the distal side of the distal end of the coil member.
The light irradiation medical device according to claim 1, wherein the inner surface of the resin tube and the outer peripheral surface of the light diffusing portion are in contact with each other.
The light irradiation medical device according to claim 1, wherein the inner surface of the resin tube on the proximal side of the reduced diameter portion is not in contact with the outer peripheral surface of the optical fiber.
further comprising a handle connected to the proximal portion of the resin tube;
2. The light irradiation medical device according to claim 1, wherein a proximal portion of said coil member is fixed to said handle.
The light irradiation medical device according to claim 1, wherein the wire is in contact with the inner surface of the resin tube over its entire length.
The light irradiation medical device according to any one of claims 1 to 6, wherein the outer peripheral surface of the optical fiber and the inner peripheral surface of the coil member are fixed.
an optical fiber having a resin tube, a light diffusing portion extending in the longitudinal direction of the resin tube in a predetermined section of the distal portion and emitting light radially outward of the resin tube, and a cylindrical member. and preparing a core material having a first region with a predetermined outer diameter and a second region with a larger outer diameter than the first region;
inserting the core material into the lumen of the resin tube;
a step of heating the resin tube to thermally shrink the resin tube to form a reduced diameter portion in which the lumen narrows toward the distal side with respect to the resin tube;
removing the core material from the lumen of the resin tube;
A method for manufacturing a light irradiation medical device, comprising: disposing the cylindrical member and the optical fiber in the inner cavity of the resin tube, and bringing the distal end portion of the cylindrical member into contact with the inner surface of the reduced diameter portion. .
The method for manufacturing a light irradiation medical device according to claim 8, wherein the inner surface of the resin tube on the distal side of the reduced diameter portion is in contact with the outer peripheral surface of the light diffusing portion.
The method for manufacturing a light irradiation medical device according to claim 8, wherein the inner surface of the resin tube on the proximal side of the reduced diameter portion is not in contact with the outer peripheral surface of the optical fiber.
A first resin tube, a second resin tube having an inner diameter larger than that of the first resin tube, and the first resin tube and the second resin tube extending in a predetermined section of a distal portion in the longitudinal direction of the first resin tube and the second resin tube. preparing an optical fiber having a light diffusing portion that emits light outward in the radial direction of at least one of the first resin tube and the second resin tube; and a cylindrical member;
connecting the second resin tube to the proximal portion of the first resin tube to form a resin tube, and forming a reduced diameter portion with a lumen narrowing toward the distal side of the resin tube; ,
A method for manufacturing a light irradiation medical device, comprising: disposing the cylindrical member and the optical fiber in the inner cavity of the resin tube, and bringing the distal end portion of the cylindrical member into contact with the inner surface of the reduced diameter portion. .
In the step of connecting the second resin tube to the proximal portion of the first resin tube to form a resin tube, and forming a reduced diameter portion with a lumen narrowing toward the distal side with respect to the resin tube ,
a step of inserting a core material having a first region with a predetermined outer diameter and a second region with a larger outer diameter than the first region into the lumen of the resin tube;
a step of heating the resin tube to thermally shrink the resin tube to form a reduced diameter portion in which the lumen narrows toward the distal side with respect to the resin tube;
The method for manufacturing a light irradiation medical device according to claim 11, further comprising the step of taking out the core material from the inner cavity of the resin tube.
In the step of inserting the core material into the lumen of the resin tube, the first region of the core material is arranged in the lumen of the first resin tube, and the second region of the core material is the second resin tube. 13. The method for manufacturing the photoirradiation medical device according to claim 12, wherein the device is arranged in the lumen of a tube.
The method for manufacturing a light irradiation medical device according to claim 11, wherein the inner surface of the first resin tube and the outer peripheral surface of the light diffusing portion are in contact with each other.
The method for manufacturing a light irradiation medical device according to claim 11, wherein the inner surface of the second resin tube and the outer peripheral surface of the optical fiber are not in contact with each other.
13. The light irradiation according to claim 8 or 12, wherein the core member has, in the second region, a tapered portion extending from the end of the first region and having an outer diameter that decreases toward the distal side. A method for manufacturing a medical device.
13. The light irradiation according to claim 8, further comprising a step of inserting the optical fiber into the lumen of the tubular member before arranging the tubular member and the optical fiber into the lumen of the resin tube. A method for manufacturing a medical device.
The method for manufacturing a light irradiation medical device according to claim 17, wherein the cylindrical member and the optical fiber are fixed with the optical fiber inserted into the lumen of the cylindrical member.
The method for manufacturing a light irradiation medical device according to claim 8 or 12, wherein the cylindrical member has a coil portion in which a wire is spirally wound.
The method for manufacturing a light irradiation medical device according to claim 19, wherein the wire is in contact with the inner surface of the resin tube over its entire length.