Living body insertion device

Abstract

A living body insertion device according to the present disclosure comprises an insertion unit that is insertable into a living body and defines a central axis line along the direction of insertion into the living body. The insertion unit includes a base and a coating layer that covers the outside of the base. The insertion unit includes a light transmission restriction part in which the base is covered by the coating layer and a light transmission part in which the base is not covered by the coating layer. The light transmission restriction part and the light transmission part are located adjacent to each other. The maximum height of the outer surface of the light transmission restriction part from the outer surface of the base is higher than the maximum height of the outer surface of the light transmission part from the outer surface of the base. The thickness of the coating layer of the light transmission restriction part is not constant and is the thinnest at the boundary position between the light transmission restriction part and the light transmission part.

Description

Bioinsertion Device

[0001] The present disclosure relates to a bioinsertion device.

[0002] Phototherapy devices used to irradiate abnormal tissue with therapeutic light are known. Patent Document 1 describes this type of phototherapy device. The phototherapy device described in Patent Document 1 includes a balloon having a defined treatment window that delivers irradiation to a defined area. The treatment window of the balloon in Patent Document 1 is defined by coating the periphery with a reflective material.

[0003] Japanese Patent Application Laid-Open No. 2005-46640

[0004] In the balloon as an insert described in Patent Document 1, a step formed by the reflective material is formed at the boundary between the treatment window, in which the base body of the balloon is not coated with a reflective material as a covering layer, and the light-shielding portion, in which the base body is coated with a reflective material. Therefore, due to sliding during the treatment procedure, a load is easily applied to the step formed by the reflective material, and there is a risk that the reflective material will peel off from the boundary.

[0005] The present disclosure aims to provide a biological insertion device including an insert that can prevent peeling of a coating layer at the boundary between the presence and absence of the coating layer, and a biological insertion device that includes a balloon that can prevent peeling of a coating film portion at the boundary between the presence and absence of the coating film portion.

[0006] A first aspect of the present disclosure provides a biological insertion device: (1) comprising an insert that is insertable into a living body and defines a central axis along a direction of insertion into the living body, the insert comprising: a base body; and a coating layer that covers the outside of the base body, the insert comprising: a light transmission limiting portion in which the base body is covered with the coating layer; and a light transmitting portion in which the base body is not covered with the coating layer, the light transmission limiting portion and the light transmitting portion are arranged adjacent to each other, the maximum height of the outer surface of the light transmission limiting portion from the outer surface of the base body is higher than the maximum height of the outer surface of the light transmitting portion from the outer surface of the base body, and the thickness of the coating layer of the light transmission limiting portion is not constant and is thinnest at a boundary position between the light transmission limiting portion and the light transmitting portion.

[0007] A biological insertion device according to one embodiment of the present disclosure is the biological insertion device according to (1) above, wherein: (2) the light transmission limiting portion and the light transmitting portion are arranged adjacent to each other in a circumferential direction around the central axis; and in a cross-sectional view of a cross section passing through the light transmission limiting portion and the light transmitting portion and perpendicular to the central axis, the thickness of the coating layer of the light transmission limiting portion varies with position in the circumferential direction and is thinnest at a boundary position between the light transmission limiting portion and the light transmitting portion in the circumferential direction.

[0008] A biological insertion device according to one embodiment of the present disclosure is (3) the biological insertion device described in (2) above, in which, in the cross-sectional view, the thickness of the coating layer of the light transmission limiting portion gradually decreases from the position of maximum thickness toward the boundary position in the circumferential direction.

[0009] A biological insertion device according to one embodiment of the present disclosure is (4) the biological insertion device described in (3) above, in which, in the cross-sectional view, the covering layer of the light transmission limiting portion has a covering edge portion whose thickness continues to decrease as it approaches the boundary position.

[0010] One embodiment of the present disclosure provides a biological insertion device as described in any one of (1) to (4) above, wherein: (5) the insert body is an expandable body that can expand and contract radially around the central axis and that houses or can house a light irradiation unit therein; the base body is capable of transmitting light from the light irradiation unit; the transmittance of the coating layer for light from the light irradiation unit is lower than the transmittance of the base body for light from the light irradiation unit; and the expandable body comprises a light transmission window portion consisting of the light transmission unit and a light blocking portion consisting of the light transmission limiting portion.

[0011] A biological insertion device according to one embodiment of the present disclosure is (6) the biological insertion device according to (5) above, in which the transmittance of the coating layer for light from the light irradiation unit is smaller than the reflectance and absorptance of the coating layer for light from the light irradiation unit.

[0012] A biological insertion device according to one embodiment of the present disclosure is (7) the biological insertion device according to (6) above, in which the coating layer is a reflector having a reflectance of light from the light irradiation unit that is greater than an absorptance of light from the light irradiation unit.

[0013] A biological insertion device according to one embodiment of the present disclosure is (8) a biological insertion device according to any one of (5) to (7) above, which includes a tubular body disposed inside the expansion body, and the tubular body defines an internal storage space that contains or can contain the light irradiation unit.

[0014] A biological insertion device according to one embodiment of the present disclosure is the biological insertion device according to any one of (1) to (8) above, wherein (9) the light transmission limiting portion and the light transmitting portion are arranged adjacent to each other in a central axis direction along the central axis, and in a cross-sectional view of a cross section passing through the light transmission limiting portion and the light transmitting portion and parallel to the central axis, the covering layer of the light transmission limiting portion has a covering edge portion whose thickness gradually decreases as it approaches a boundary position between the light transmission limiting portion and the light transmitting portion in the central axis direction.

[0015] A second aspect of the present disclosure is a bioinsertion device (10) comprising a balloon provided at a distal end of the bioinsertion device, the balloon comprising a light-shielding portion having a coating film portion formed on the surface of a base body, and a light-transmitting window portion where the coating film portion is not formed on the surface of the base body, and the thickness of the coating film portion gradually decreases toward a boundary position between the light-shielding portion and the light-transmitting window portion.

[0016] According to the present disclosure, it is possible to provide a biological insertion device including an insert that can prevent peeling of a coating layer at the boundary position between the presence and absence of the coating layer, and also to provide a biological insertion device including a balloon that can prevent peeling of a coating film portion at the boundary position between the presence and absence of the coating film portion.

[0017] Fig. 3 is a diagram showing an example of an endoscopic system including a light irradiation device as one embodiment of a living body insertion device according to the present disclosure. Fig. 4 is a diagram showing the light irradiation device shown in Fig. 1. Fig. 5 is a cross-sectional view of the light irradiation device at the position of line II in Fig. 2. Fig. 6 is a cross-sectional view showing a cross section parallel to the central axis of an insertion body. Fig. 7 is a diagram showing an example of a method for forming the coated edge portion shown in Fig. 3. Fig. 8 is a diagram showing a modified example of the coating layer shown in Fig. 3. Fig. 9 is a cross-sectional view of a modified example of the light irradiation device shown in Fig. 1 at the same position as Fig. 3.

[0018] Hereinafter, an embodiment of a biological insertion device according to the present disclosure will be illustrated and described with reference to the drawings. In each drawing, the same components are designated by the same reference numerals.

[0019] FIG. 1 is a diagram illustrating an example of an endoscopic system 100 including a light irradiation device 1 as an embodiment of a living body insertion device according to the present disclosure. The endoscopic system 100 illustrated in FIG. 1 includes an endoscopic apparatus 101, a control device 102 connected to the endoscopic apparatus 101, a display unit 103 such as a monitor connected to the control device 102, a light source apparatus 104, and the light irradiation device 1. The endoscopic apparatus 101 is provided with a treatment instrument channel through which the light irradiation device 1 can be inserted as a treatment instrument. As illustrated in FIG. 1, the light irradiation device 1 is inserted into the treatment instrument channel of the endoscopic apparatus 101 and delivered to a lesion in an inner cavity. The control apparatus 102 includes a light source unit 102a that supplies illumination light to the endoscopic apparatus 101 and a processor unit 102b that performs various image processing on an image signal from the endoscopic apparatus 101 to convert it into a video signal. The control apparatus 102 may also include an input unit such as a keyboard. The display unit 103 can display an image captured by the endoscope device 101 based on a video signal generated by the processor unit 102 b of the control device 102 .

[0020] The light irradiation device 1 can be used for, for example, photodynamic therapy (PDT) and photoimmunotherapy (PIT). In this embodiment, the light irradiation device 1 is used in photoimmunotherapy, which destroys target cells by irradiating light onto a drug adsorbed on target cells, as taught in Japanese Patent No. 6127045. The target cells are tumor cells, such as cancer cells or cells of precancerous lesions. In this treatment method, a photosensitizer is used as the drug, which comprises an antibody that specifically binds only to a unique antigen on the surface of tumor cells and a photosensitizer that pairs with the antibody. The antibody is not particularly limited, but examples include panitumumab, trastuzumab, HuJ591, pertuzumab, lapatinib, palbociclib, and olaparib. The photosensitizer is, for example, but not limited to, hydrophilic phthalocyanine, a substance that responds to near-infrared light with a wavelength of approximately 700 nm (IR700). When IR700 is exposed to near-infrared light with a wavelength of approximately 660 to 740 nm, the ligands of the functional groups that ensure its water solubility are cleaved, causing a structural change from water solubility to hydrophobicity. This structural change pulls out membrane proteins, creating holes in the cell membrane and allowing water to enter the cell, thereby rupturing and destroying tumor cells. Furthermore, IR700 is excited by near-infrared light and emits fluorescence with a wavelength different from the excitation wavelength. For example, when IR700 is excited by near-infrared light with a wavelength around 690 nm, it emits fluorescence with a wavelength around 700 nm. IR700 undergoes a structural change while emitting fluorescence due to a photoreaction, and ceases to emit fluorescence once it has destroyed tumor cells and fulfilled its role as a drug. The light irradiation device 1 can be inserted into a cavity such as a biological lumen. The light irradiation device 1 may be used together with an endoscope device 101, as shown in FIG. 1 . However, the light irradiation device 1 does not necessarily have to be used together with the endoscope device 101. There is no particular limitation on the cavity into which the light irradiation device 1 can be inserted. As shown in Fig. 1 , the light irradiation device 1 may be used, for example, for treating gastrointestinal cancer through a treatment instrument channel of an endoscopic apparatus 101 inserted into a hollow organ such as the gastrointestinal tract (e.g., esophagus, stomach, small intestine, large intestine), urinary tract, or blood vessel.The light irradiation device 1 of this embodiment is used in photoimmunotherapy, which destroys target cells by irradiating light onto a drug adsorbed on target cells, as taught in Japanese Patent No. 6127045. The target cells are tumor cells, such as cancer cells or cells of precancerous lesions. In this treatment method, a photosensitizer is used as the drug, which comprises an antibody that specifically binds to a specific antigen on the surface of tumor cells and a photosensitizer that pairs with the antibody. The antibody is not particularly limited, but examples include panitumumab, trastuzumab, HuJ591, pertuzumab, lapatinib, palbociclib, and olaparib. The photosensitizer is, for example, but not limited to, a hydrophilic phthalocyanine (IR700) that reacts to near-infrared light with a wavelength of approximately 700 nm. When IR700 is exposed to near-infrared light with a wavelength of approximately 660 to 740 nm, the functional group ligand that ensures water solubility is cleaved, resulting in a structural change from water solubility to hydrophobicity. This structural change pulls out membrane proteins, opening holes in the cell membrane and allowing water to enter the cell, rupturing and destroying tumor cells. IR700 is also excited by near-infrared light and emits fluorescence at a wavelength different from the excitation wavelength. For example, when IR700 is excited by near-infrared light with a wavelength around 690 nm, it emits fluorescence with a wavelength around 700 nm. IR700 undergoes a structural change while emitting fluorescence through a photoreaction, and once it has destroyed tumor cells and fulfilled its role as a drug, it ceases to emit fluorescence.

[0021] In the present embodiment, a light irradiation device 1 will be described as an example of one embodiment of a biological insertion device according to the present disclosure, but the biological insertion device according to the present disclosure is not limited to a light irradiation device. The biological insertion device according to the present disclosure may be a biological insertion device used for a treatment other than a phototherapy, such as a balloon catheter or other catheter that is not used for a phototherapy.

[0022] FIG. 2 is a diagram showing the light irradiation device 1. As shown in FIG. 2, the light irradiation device 1 includes an expandable body 30 serving as an insertion body 2. The insertion body 2 is insertable into a living body and defines a central axis O1 along the insertion direction into the living body. More specifically, the expandable body 30 serving as the insertion body 2 in this embodiment is a balloon. The balloon serving as the expandable body 30 is provided at the distal end of the light irradiation device 1. The expandable body 30 defines a central axis O1 along the insertion direction into the living body and is configured to be expandable and contractible in a radial direction F. Here, the "radial direction F" refers to the radial direction of an imaginary circle centered on the central axis O1. FIG. 2 is a cross-sectional view of the light irradiation device 1 taken along a cross section passing through the central axis O1 and parallel to the central axis O1.

[0023] FIG. 3 is a cross-sectional view of the light irradiation device 1 taken along line II in FIG. 2 . As shown in FIG. 3 , the insert 2 includes a base body 91a and a coating layer 91b covering the outside of the base body 91a. The base body 91a in this embodiment is made of a light-transmitting material that can transmit light from the light irradiation unit 200 (described later). While the base body 91a in this embodiment is a single layer, it may be a laminate having multiple layers stacked together. The coating layer 91b in this embodiment is made of a light-transmittance-limiting material that has a lower transmittance for light from the light irradiation unit 200 (described later) than the base body 91a. Furthermore, although the coating layer 91b in this embodiment is the outermost outer layer of the insert 2, it is not limited to being the outermost outer layer of the insert 2.

[0024] The insert 2 also includes a light-transmitting portion 2a and a light-transmitting limiting portion 2b. The light-transmitting portion 2a is a portion of the base body 91a that is not covered by the coating layer 91b. The light-transmitting portion 2b is a portion of the base body 91a that is covered by the coating layer 91b. As shown in FIGS. 2 and 3 , the light-transmitting portion 2a and the light-transmitting limiting portion 2b in this embodiment are disposed adjacent to each other in the central axis direction D and the circumferential direction E. Here, the "central axis direction D" refers to the direction along the central axis O1. The "circumferential direction E" refers to the circumferential direction around the central axis O1.

[0025] As shown in FIG. 3 , the maximum height H1 of the outer surface of the light transmission limiting section 2b from the outer surface of the base body 91a is higher than the maximum height of the outer surface of the light transmitting section 2a from the outer surface of the base body 91a. The insert 2 of this embodiment, for example, is composed of a single-layer base body 91a and a single-layer coating layer 91b. Therefore, the maximum height H1 of the outer surface of the light transmission limiting section 2b from the outer surface of the base body 91a of this embodiment is equal to the maximum thickness T1max of the coating layer 91b. Furthermore, the maximum height H1 of the outer surface of the light transmitting section 2a from the outer surface of the base body 91a of this embodiment is zero. As shown in the modified example of FIG. 7 , when the insert 2 has another outer layer 91c that covers both the light transmitting section 2a and the light transmission limiting section 2b, the maximum height H1 of the outer surface of the light transmission limiting section 2b from the outer surface of the base body 91a is equal to the maximum thickness of the laminate of the coating layer 91b and the outer layer 91c. 7 may be a coating film portion such as a hydrophilic coating layer whose maximum thickness T3max is smaller than the maximum thickness T1max of the coating layer 91b.

[0026] 3 , in a cross-sectional view of a cross section that passes through the light transmitting portion 2a and the light transmission limiting portion 2b and is perpendicular to the central axis O1, the thickness T1 of the coating layer 91b of the light transmission limiting portion 2b is not constant but varies depending on the position in the circumferential direction E, and is thinnest at a boundary position BL1 between the light transmitting portion 2a and the light transmission limiting portion 2b in the circumferential direction E. By doing so, at the boundary position BL1 between the light transmitting portion 2a and the light transmission limiting portion 2b, where the coating layer 91b is present or absent, the thickness T1 of the edge of the coating layer 91b of the light transmission limiting portion 2b becomes the thinnest minimum thickness T1min among the coating layer 91b of the light transmission limiting portion 2b. This makes it possible to reduce the step on the outer surface of the insert 2, which is caused by the presence or absence of the coating layer 91b of the light transmission limiting portion 2b, at the boundary position BL1 between the light transmitting portion 2a and the light transmission limiting portion 2b in the circumferential direction E. Therefore, the probability that the above-mentioned step portion will come into contact with an obstacle when handling the device inside the body is reduced, and the coating layer 91b can be prevented from peeling off from the boundary position BL1 between the light-transmitting portion 2a and the light-transmitting limiting portion 2b in the circumferential direction E due to contact.

[0027] Specifically, in the cross-sectional view (see FIG. 3 ), the thickness T1 of the coating layer 91b of the light transmission limiting unit 2b of this embodiment gradually decreases from the position of the maximum thickness T1max toward the boundary position BL1 in the circumferential direction E. Here, the phrase "the thickness T1 of the coating layer 91b gradually decreases toward the boundary position BL1 in the circumferential direction E" does not necessarily mean that the thickness T1 of the coating layer 91b continuously decreases (decreases in an inclined manner) toward the boundary position BL1 in the circumferential direction E, but also means that the thickness T1 of the coating layer 91b intermittently decreases (decreases in a stepped manner) toward the boundary position BL1 in the circumferential direction E. In other words, the coating layer 91b whose thickness T1 gradually decreases toward the boundary position BL1 in the circumferential direction E in the cross-sectional view (see FIG. 3 ) may include a portion where the thickness T1 is constant regardless of the position in the circumferential direction E. In this way, in the cross-sectional view (see FIG. 3 ), the thickness T1 of the coating layer 91b gradually decreases from the position of the maximum thickness T1max to the boundary position BL1, which makes it difficult for a large step to be formed on the outer surface of the light transmission limiting portion 2b in the circumferential direction E. Therefore, peeling of the coating layer 91b in the circumferential direction E due to a load being applied to the step on the outer surface of the light transmission limiting portion 2b can be suppressed.

[0028] More specifically, in the cross-sectional view (see FIG. 3 ), the coating layer 91b of this embodiment includes a main coating portion 91b1 and a coating edge portion 91b2. The main coating portion 91b1 is a portion having a substantially constant maximum thickness T1max in the cross-sectional view (see FIG. 3 ). The coating edge portion 91b2 is a portion that is continuous with the main coating portion 91b1 and extends to the boundary position BL1, with the thickness T1 gradually decreasing as it approaches the boundary position BL1. In other words, the coating edge portion 91b2 includes the edge of the above-mentioned coating layer 91b having the minimum thickness T1min and is adjacent to the light-transmitting portion 2a. At the boundary position BL1, the angle θ1 of contact between the coating edge portion 91b2 and the light-transmitting portion 2a is an obtuse angle. Here, the "angle of contact θ1" is the angle between the tangent to the covering edge portion 91b2 and the tangent to the light-transmitting portion 2a. In contrast, the main covering portion 91b1 is a portion that is continuous with the covering edge portion 91b2 on the opposite side of the covering edge portion 91b2 from the light-transmitting portion 2a in the circumferential direction E. As shown in FIG. 3 , the light transmission limiting portion 2b of this embodiment is adjacent to the light-transmitting portion 2a on both sides in the circumferential direction E. That is, the covering layer 91b of this embodiment includes covering edge portions 91b2 located at both ends in the circumferential direction E and a main covering portion 91b1 located between the covering edge portions 91b2 on both sides in the circumferential direction E. The length L1 of the covering edge portion 91b2 in the circumferential direction E is not particularly limited, but may be, for example, 1 to 15 mm, preferably 1 to 10 mm, and more preferably 1 to 5 mm.

[0029] While FIG. 3 illustrates the main coating portion 91b1 as having a substantially constant thickness T1, the present invention is not limited to this configuration. As shown in FIG. 6 , the main coating portion 91b1 may not include a portion having the maximum thickness T1max, and the edge coating portion 91b2 may include a portion having the maximum thickness T1max. In the example shown in FIG. 6 , the main coating portion 91b1 has a substantially constant thickness that is thinner than the maximum thickness T1max. Furthermore, the edge coating portion 91b2 includes a portion having the maximum thickness T1max, and its thickness gradually decreases from the portion having the maximum thickness T1max toward the boundary position BL1. By providing the edge coating portion 91b2 with the maximum thickness T1max in this manner, the portion of the outer surface of the coating layer 91b having the maximum thickness T1max can be more closely attached to the biological tissue defining the lumen near the boundary position BL1 than when the main coating portion 91b1 includes a portion having the maximum thickness T1max. Therefore, as will be described later, when the light transmitting portion 2a is used as the light transmitting window portion 31, it is possible to prevent light irradiated from the light transmitting window portion 31 from leaking in the circumferential direction E from a gap between the biological tissue that defines the lumen and the boundary position BL1 toward between the main covering portion 91b1 and the biological tissue. Also, liquid is likely to accumulate between the light transmitting window portion 31, which will be described later, and the biological tissue. Therefore, as will be described later, when a viewing window 38 is provided as the light transmitting portion 2a separate from the light transmitting window portion 31, it becomes easier to monitor the lesion in the biological tissue from the viewing window 38 through the light transmitting window portion 31.

[0030] As described above, the light transmitting portion 2 a and the light transmission limiting portion 2 b of this embodiment are arranged adjacent to each other in the circumferential direction E, and also adjacent to each other in the central axis direction D. More specifically, the light transmission limiting portion 2 b of this embodiment is arranged so as to surround the periphery of the light transmitting portion 2 a.

[0031] FIG. 4 is an enlarged cross-sectional view showing the vicinity of the expandable body 30 in FIG. 2 . FIG. 4 is also a cross-sectional view of a cross section parallel to the central axis O1 that passes through the light transmitting portion 2a and the light transmission limiting portion 2b. As shown in FIG. 4 , in a cross-sectional view of a cross section parallel to the central axis O1 that passes through the light transmitting portion 2a and the light transmission limiting portion 2b, the coating layer 91b of this embodiment includes a main coating portion 91b3 and a coating edge portion 91b4. The main coating portion 91b3 has a substantially constant thickness T1 in the cross-sectional view shown in FIG. 4 . The thickness T1 of the main coating portion 91b3 may be substantially equal to the thickness T1 of the main coating portion 91b1 (see FIG. 3 ). In other words, the thickness T1 of the main coating portion 91b3 may be substantially equal to the maximum thickness T1max described above. In the cross-sectional view shown in FIG. 4 , the covering edge portion 91b4 is a portion that is continuous with the main covering portion 91b3 and extends to a boundary position BL2, with a thickness T1 that gradually decreases as the covering edge portion 91b4 approaches the boundary position BL2. The thickness T1 of the covering edge portion 91b4 at the boundary position BL2 may be substantially equal to the thickness T1 of the covering edge portion 91b2 (see FIG. 3 ) at the boundary BL1 (see FIG. 3 ). At the boundary position BL2, the angle θ2 of contact of the covering edge portion 91b4 with the light-transmitting portion 2a is an obtuse angle. Here, the "angle of contact θ2" refers to the angle between a tangent to the covering edge portion 91b4 and a tangent to the light-transmitting portion 2a. As shown in FIG. 4 , the light transmission limiting unit 2b of this embodiment includes covering edge portions 91b4 at positions adjacent to the light transmission window 31 on both sides of the light transmission window 31 in the central axial direction D as the light transmission portion 2a, the covering edge portions 91b4 having a thickness T1 gradually decreasing toward a boundary position BL2 with the light transmission window 31. As shown in FIG. 4 , the light transmission limiting unit 2b of this embodiment does not include the covering edge portion 91b4 at a position adjacent to the viewing window 38 in the central axial direction D as the light transmission portion 2a, but this configuration is not limited thereto. The covering edge portion 91b4 may be formed at a position adjacent to the viewing window 38 in the central axial direction D as the light transmission portion 2a. The length L2 of the covering edge portion 91b4 in the central axial direction D is not particularly limited, but may be, for example, 1 to 15 mm, preferably 1 to 10 mm, and more preferably 1 to 5 mm.

[0032] In this way, in a cross-sectional view parallel to the central axis O1 that passes through the light transmitting portion 2a and the light transmission limiting portion 2b (see FIG. 4), the provision of the above-mentioned covering edge portion 91b4 can reduce the step on the outer surface of the light transmission limiting portion 2b, which is caused by the presence or absence of the covering layer 91b, at the boundary position BL2 between the light transmitting portion 2a and the light transmission limiting portion 2b in the central axis direction D. Therefore, peeling of the covering layer 91b from the boundary position BL2 between the light transmitting portion 2a and the light transmission limiting portion 2b in the central axis direction D can be suppressed.

[0033] 4, it is preferable that the thickness T1 of the coating layer 91b of the light transmission limiting portion 2b gradually decrease from the position of the maximum thickness Tmax toward the boundary position BL2 between the light transmitting portion 2a and the light transmission limiting portion 2b in the central axis direction D. By doing so, it is difficult for a step to be formed on the outer surface of the light transmission limiting portion 2b in the central axis direction D due to a variation in the thickness T1 of the coating layer 91b. Therefore, peeling of the coating layer 91b toward the central axis direction D due to a load being applied to the step on the outer surface of the light transmission limiting portion 2b can be suppressed.

[0034] 4, the main coating portion 91b3 is shown as a portion having a substantially constant thickness T1 of a maximum thickness T1max, but is not limited to this configuration. For example, the main coating portion 91b3 may not include a portion having the maximum thickness T1max, and the coating edge portion 91b4 may include a portion having the maximum thickness T1max.

[0035] As described above, in the expandable body 30 serving as the insert 2 of the present embodiment, the covering layer 91b is thinned at both the boundary position BL1 where the light transmitting portion 2a and the light transmission limiting portion 2b are adjacent in the circumferential direction E and the boundary position BL2 where the light transmitting portion 2a and the light transmission limiting portion 2b are adjacent in the central axial direction D, but is not limited to this configuration. The covering layer 91b of the insert 2 may be thinned at the boundary position BL1 where the light transmitting portion 2a and the light transmission limiting portion 2b are adjacent in the circumferential direction E, but not thinned at the boundary position BL2 where the light transmitting portion 2a and the light transmission limiting portion 2b are adjacent in the central axial direction D. Alternatively, the covering layer 91b of the insert 2 may be thinned at the boundary position BL2 where the light transmitting portion 2a and the light transmission limiting portion 2b are adjacent in the central axial direction D, but not thinned at the boundary position BL1 where the light transmitting portion 2a and the light transmission limiting portion 2b are adjacent in the circumferential direction E. However, from the viewpoint of suppressing peeling of the coating layer 91b in both the circumferential direction E and the central axis direction D, it is preferable that the coating layer 91b of the insert 2 be thinned at both boundary positions BL1 and BL2, as in this embodiment.

[0036] The light irradiation device 1 of the present embodiment includes the expansion body 30 as an example of the insertion body 2 including the light transmitting portion 2 a and the light transmission limiting portion 2 b described above, but is not limited to this configuration. The light irradiation device 1 may also include an insertion body 2 that includes a light transmitting portion 2 a and a light transmission limiting portion 2 b different from the expansion body 30. In other words, the insertion body 2 of the biological insertion device according to the present disclosure is not limited to the expansion body 30 as long as it is insertable into a living body, defines a central axis O1 along the insertion direction into the living body, and includes adjacent light transmitting portions 2 a and light transmission limiting portions 2 b. Therefore, the insertion body 2 may be, for example, a tubular body.

[0037] Hereinafter, the light irradiation device 1 of this embodiment will be described in further detail with reference to FIGS.

[0038] As shown in FIG. 2 , the light irradiation device 1 of this embodiment includes a long first tubular body 10 and a long second tubular body 20 , an expandable body 30 , and a hub 40 .

[0039] Hereinafter, in the light irradiation device 1, the direction along the central axis O2 of the first tubular body 10 will be referred to as the central axis direction A. The central axis O2 of the first tubular body 10 in this embodiment coincides with the central axis O1 of the expansion body 30 serving as the insertion body 2 described above. That is, the central axis direction A in this embodiment is the same as the central axis direction D described above. Furthermore, in the light irradiation device 1, the direction from the proximal side to the distal side of the central axis direction A will be referred to as the insertion direction A1, and the direction from the distal side to the proximal side of the central axis direction A will be referred to as the removal direction A2. The insertion direction A1 in this embodiment is the same as the insertion direction of the expansion body 30 serving as the insertion body 2 described above. Furthermore, in the light irradiation device 1, the direction around the central axis O2 of the first tubular body 10 will be referred to as the circumferential direction B. The circumferential direction B in this embodiment is the same as the circumferential direction E described above. Furthermore, in the light irradiation device 1, the radial direction of an imaginary circle centered on the central axis O2 of the first tubular body 10 will be referred to as a radial direction C. The radial direction C in this embodiment is the same as the radial direction F described above.

[0040] First, an example of a method of using the light irradiation device 1 will be described. Prior to treatment using the light irradiation device 1, a photosensitive substance is administered into the body. The method of administering the photosensitive substance into the body is not particularly limited as long as it can reach tumor cells. For example, it may be intravascular administration, which in this embodiment is intravenous administration. Approximately 12 to 36 hours after intravenous administration, light irradiation treatment using the light irradiation device 1 of this embodiment is performed. A light irradiator 201 (described later) is inserted into the first tubular body 10 of the light irradiation device 1, and a light irradiation unit 200 (provided at the distal end of the light irradiator 201 in the central axis direction A) is positioned at a predetermined position within the first tubular body 10. A hub 40 (described later) includes a hub main body 41 and a connecting portion 42. The connecting portion 42 of the hub 40 holds the light irradiator 201 so as to surround it. The light irradiator 201 may be fixed to the light irradiation device 1 by rotating and screwing the connecting portion 42 relative to the hub body 41 while inserted into the first tubular body 10 of the light irradiation device 1. Conversely, the light irradiator 201 can be removed from the first tubular body 10 of the light irradiation device 1 by unscrewing the hub body 41 and the connecting portion 42. In this embodiment, the light irradiator 201 includes a light irradiation unit 200 provided at the distal end in the central axis direction A and a light transmission member 202 such as an optical fiber connected to the light irradiation unit 200 and extending toward the proximal end in the central axis direction A. The proximal end of the light transmission member 202 is connected to the light source device 104. For example, the light irradiator 201 may be configured with a side-emitting optical fiber capable of irradiating light radially outward from the distal end. Furthermore, the expansion body 30 of the light irradiation device 1 is in a contracted state in this state.

[0041] Next, the light irradiation device 1 and the light irradiator 201 fixed to this light irradiation device 1 are inserted into a living body through the treatment tool channel of the endoscopic apparatus 101 (see FIG. 1 ). At this time, the position of a light-transmitting window portion 31 (described later) in the expandable body 30 is aligned in the central axis direction A and the circumferential direction B with the position to be irradiated, such as a lesion formed in the biological tissue that defines the lumen. Alignment in the central axis direction A is performed by moving the light irradiation device 1 in the insertion direction A1 or the removal direction A2. Alignment in the circumferential direction B is performed by rotating the light irradiation device 1 in the circumferential direction B.

[0042] Next, the expandable body 30 is expanded from the contracted state. The expandable body 30 may be expanded in two stages, for example, an adjustment expanded state in which light irradiation to the irradiation target is not performed, and a treatment expanded state in which the internal pressure is higher than in the adjustment expanded state and light irradiation to the irradiation target is performed. The adjustment expanded state of the expandable body 30 may be used to fine-tune the alignment of the position of a light-transmitting window portion 31 (described later) in the expandable body 30 with the position of the irradiation target in the central axis direction A and the circumferential direction B.

[0043] By placing the expandable body 30 in a therapeutic expanded state (hereinafter simply referred to as the "expanded state"), the light-transmitting window portion 31 of the expandable body 30, which will be described later, is brought into close contact with the irradiation target. In this state, the irradiation target can be irradiated with light that is emitted from the light irradiating unit 200 and passes through the light-transmitting window portion 31 outward in the radial direction C. The irradiation time for the irradiation target is not particularly limited, but may be, for example, several minutes to several tens of minutes.

[0044] After the treatment is completed, the expansion body 30 is contracted, and the light irradiation device 1, together with the light irradiator 201, is removed from the living body through the treatment instrument channel of the endoscope apparatus 101 (see FIG. 1).

[0045] As shown in FIGS. 2 to 4 , the first tubular body 10 defines an internal storage space 10a that stores or can store a light irradiation unit 200. More specifically, the first tubular body 10 of this embodiment can store a light-emitting unit as the light irradiation unit 200 included in a light irradiator 201 that is separate from the light irradiation device 1. As described above, the light irradiator 201 may include the light irradiation unit 200 that emits light outward in the radial direction C and an optical transmission member 202, such as an optical fiber, that transmits light from the light source device 104 (see FIG. 1 ) to the light irradiation unit 200. In the light irradiator 201 of this embodiment, the light irradiation unit 200 is attached to the distal end of the optical transmission member 202. The light irradiation unit 200 of the light irradiator 201 can be inserted into the storage space 10a in the insertion direction A1 from a proximal opening 10a1 of the storage space 10a, which is located at the proximal end of the first tubular body 10. More specifically, the light irradiator 201 is inserted into the accommodation space 10a in the insertion direction A1 to a set position where the light irradiator 200 overlaps with the light-transmitting window portion 31 of the expandable body 30, which will be described later, in the central axis direction A. As shown in FIG. 2 , the distal side of the accommodation space 10a in this embodiment is closed. In the light irradiation device 1 and light irradiator 201 of this embodiment, the set position described above is realized by abutting the distal end of the light irradiator 201 against the closing wall 15b on the distal side of the accommodation space 10a of the first tubular body 10. The distal side of the accommodation space 10a of the first tubular body 10 may not be closed by the closing wall 15b, but may have a reduced diameter via a stepped surface facing the proximal side. In such a case, the set position described above may be realized by abutting the distal end of the light irradiator 201 against the stepped surface.

[0046] The light irradiation section 200 may be provided in the accommodation space 10a of the first tubular body 10. In other words, the light irradiation device 1 may be configured to include the light irradiation section 200 accommodated in the accommodation space 10a.

[0047] The intensity and wavelength of the light emitted from the light irradiating unit 200 may be appropriately selected depending on, for example, the condition and position of the lesion. The light emitted from the light irradiating unit 200 may be, for example, visible light such as near-infrared light.

[0048] The first tubular body 10 is configured to be able to transmit light emitted from the light irradiation unit 200 housed in the housing space 10a in the radial direction C. The first tubular body 10 may be formed, for example, from a transparent resin material that is able to transmit light emitted from the light irradiation unit 200. In other words, the first tubular body 10 may be configured to be able to transmit light emitted from the light irradiation unit 200 outward in the radial direction C over the entire area in the circumferential direction B.

[0049] The resin material used to form the first tubular body 10 is not particularly limited, and examples thereof include polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers; ethylene-vinyl acetate copolymers (EVA); polyvinyl chloride; polyvinylidene chloride; polystyrene; polyamide; polyimide; polyamideimide; polycarbonate; poly-(4-methylpentene-1); ionomers; acrylic resins; polymethyl methacrylate; acrylonitrile-butadiene-styrene copolymers (ABS resins); acrylonitrile-styrene copolymers (AS resins); butadiene-styrene copolymers; polyethylene Examples of the resin material include polyesters such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), and polycyclohexane terephthalate (PCT); polyether; polyether ketone (PEK); polyether ether ketone (PEEK); polyetherimide; polyacetal (POM); polyphenylene oxide; modified polyphenylene oxide; polysulfone; polyether sulfone; polyphenylene sulfide; polyarylate; aromatic polyester (liquid crystal polymer); polytetrafluoroethylene, polyvinylidene fluoride, and other fluorine-based resins. Blends containing one or more of these may also be used.

[0050] The first tubular body 10 may also be configured to have a transmission window that allows light emitted from the light emitting unit 200 to pass outward in the radial direction C only in a portion of the circumferential direction B.

[0051] The expandable body 30 covers the outside of the first tubular body 10 in the radial direction C and is configured to be expandable and contractible in the radial direction C. Specifically, the expandable body 30 of this embodiment is a balloon made of a membrane body that covers the periphery of the first tubular body 10. The expandable body 30 of this embodiment defines an annular fluid storage space 30a between itself and the outer surface of the first tubular body 10. The expandable body 30 of this embodiment is expandable outward in the radial direction C when fluid is supplied to the fluid storage space 30a. Furthermore, the expandable body 30 of this embodiment is contractable inward in the radial direction C when fluid is discharged from the fluid storage space 30a. The balloon serving as the expandable body 30 of this embodiment includes an expansion main body portion 35 that defines the annular fluid storage space 30a. The central portion of the expansion main body portion 35 of the balloon serving as the expandable body 30 of this embodiment in the central axial direction A is a peripheral wall portion 35a that is approximately cylindrical in the expanded state. In addition, both ends of the expansion main body portion 35 of the balloon serving as the expandable body 30 of this embodiment in the central axial direction A are tapered portions 35b that decrease in diameter toward the ends. As shown in Fig. 2, the tapered portions 35b may be configured in a hemispherical shape. However, the shape of the tapered portions 35b is not limited to a hemispherical shape and may be, for example, a conical shape.

[0052] The expandable body 30 is configured to house or be able to house the light irradiation unit 200 therein. Specifically, the first tubular body 10 is disposed inside the expandable body 30 of this embodiment. The light irradiation unit 200 can be housed in the housing space 10a of the first tubular body 10.

[0053] As shown in FIG. 3 , the balloon serving as the expandable body 30 includes a light-transmitting window 31 and a light-shielding portion 32. The light-transmitting window 31 is disposed in only a portion of the circumferential direction B. The light-transmitting window 31 is configured to allow light from the light-irradiating unit 200 housed in the accommodation space 10a to pass outward in the radial direction C. The light-shielding portion 32 of this embodiment is disposed adjacent to the light-transmitting window 31 in the central axis direction A and the circumferential direction B. The transmittance of the light-shielding portion 32 outward in the radial direction C of light from the light-irradiating unit 200 housed in the accommodation space 10a (hereinafter simply referred to as the “transmittance of the light-shielding portion 32”) is smaller than the transmittance of the light-transmitting window 31 outward in the radial direction C of light from the light-irradiating unit 200 housed in the accommodation space 10a (hereinafter simply referred to as the “transmittance of the light-transmitting window 31”).

[0054] More specifically, the light-transmitting window 31 of the expansion body 30 is the light-transmitting section 2a described above. Also, the light-shielding section 32 of the expansion body 30 is the light-transmitting limiting section 2b described above. In other words, the light-transmitting window 31 of the expansion body 30 is a portion on the surface of the base body 91a where a coating film portion as the covering layer 91b is not formed, and the light-shielding section 32 of the expansion body 30 is a portion on the surface of the base body 91a where a coating film portion as the covering layer 91b is formed.

[0055] The base body 91a of this embodiment may be composed of one or more transparent resin layers. The base body 91a may be composed of a single transparent resin layer, or may be a laminate in which multiple transparent resin layers are stacked. The covering layer 91b of this embodiment may be a coating film portion formed by applying it to the outer surface of the base body 91a. The method for applying the coating film portion as the covering layer 91b to the outer surface of the base body 91a is not particularly limited. The covering layer 91b may be applied to the base body 91a by, for example, dipping, spray coating, roll coating, screen printing, vacuum deposition, low-vacuum sputtering, or the like.

[0056] Examples of light-transmitting materials that form the resin layer of the base body 91a include polyethylene terephthalate, polyurethane, and polyamide.

[0057] The coating layer 91b may be made of any material, as long as it has a lower transmittance of light from the light emitting unit 200 than the base body 91a. Examples of light transmission-limiting materials that can be used for the coating layer 91b include various metal materials such as titanium oxide, barium sulfate, zinc oxide, silver, and aluminum. The coating layer 91b may also be made of a resin containing particles of the above-mentioned metal materials or carbon black. In this embodiment, the maximum thickness T1max of the coating layer 91b is 1 / 6 to 3 times the minimum thickness T2min of the base body 91a. In this embodiment, the base body 91a has a substantially constant thickness regardless of the position in the circumferential direction B when viewed in a cross section perpendicular to the central axis O1 (see FIG. 3). Therefore, the minimum thickness T2min of the base body 91a in this embodiment is the thickness T2 of the base body 91a at any position in the circumferential direction B.

[0058] In this way, of the light from the light irradiation unit 200 housed in the housing space 10a of the first tubular body 10, the light that passes through the first tubular body 10 is emitted to the outside in the radial direction C of the expansion body 30 mainly through the light-transmitting window portion 31 of the expansion body 30 that is provided only in the central axial direction A and a part of the circumferential direction B. In other words, by providing the light-transmitting window portion 31 only in the central axial direction A and a part of the circumferential direction B, the expansion body 30 has optical directivity in which the light emitted from the inside of the expansion body 30 to the outside in the radial direction C is mainly limited to the central axial direction A and a part of the circumferential direction B.

[0059] Next, we will explain the transmittance, reflectance, and absorptance of the coating layer 91b in the expandable body 30 as the insert 2 of this embodiment. The terms "transmittance," "reflectance," and "absorbance" used here refer to the transmittance, reflectance, and absorptance of light from the light irradiator 200 housed in the housing space 10a from the inside to the outside in the radial direction C. The sum of the transmittance, reflectance, and absorptance of the coating layer 91b is 100%.

[0060] The transmittance of the coating layer 91b is preferably smaller than both the reflectance and the absorptance of the coating layer 91b, thereby preventing light from being directly irradiated onto normal tissue other than the lesion through the light-shielding portion 32. From the viewpoint of bringing the transmittance closer to 0, the coating layer 91b may be formed of, for example, a black layer.

[0061] Furthermore, the covering layer 91b may be, for example, a reflector whose reflectance is greater than its absorptance. In other words, the covering layer 91b may be configured so that its transmittance is kept relatively low and the relationship of transmittance < absorptance < reflectance is satisfied. Such a covering layer 91b may be configured, for example, as a white layer. In this manner, the light from the light emitting unit 200 is more likely to be reflected by the light-shielding unit 32 toward the light-transmitting window 31. Therefore, the light energy of the light emitted outward in the radial direction C from the light-transmitting window 31 can be increased.

[0062] 3 , in the light irradiation device 1 of this embodiment, the light-shielding portion 32 extends in the circumferential direction B from a position adjacent to one end of the light-transmitting window portion 31 to a position adjacent to the other end of the light-transmitting window portion 31. In other words, in a cross-sectional view of the light irradiation device 1 passing through the light-transmitting window portion 31 and perpendicular to the central axis direction A (see FIG. 3 ), the expandable body 30 in the expanded state has only one light-transmitting window portion 31 and one light-shielding portion 32 in the circumferential direction B.

[0063] 2 and 4 , the expandable body 30 may include a viewing window 38 as another light-transmitting portion 2a at a position proximal to the light-transmitting window 31 as the light-transmitting portion 2a in the central axial direction A. As described above, the expandable body 30 of this embodiment includes a light-shielding portion 32 as a light-transmitting limiting portion 2b at a position adjacent to the light-transmitting window 31 as the light-transmitting portion 2a in the circumferential direction B, as well as at a position adjacent to the light-transmitting window 31 in the central axial direction A. The viewing window 38 is not continuous with the light-transmitting window 31, but is disposed proximal to the light-transmitting window 31, separated from the light-transmitting window 31 by the light-shielding portion 32. The viewing window 38 may be formed, for example, by a base body 91a, similar to the light-transmitting window 31 described above. By providing such a viewing window portion 38, the light-transmitting window portion 31 and the lesion area that comes into contact with this light-transmitting window portion 31 can be monitored through the viewing window portion 38 using the endoscopic device 101 (see Figure 1).

[0064] More specifically, the first tubular body 10 of this embodiment includes a protruding portion 15 that protrudes distally from the distal end 20a1 of the second tubular body 20, which will be described later. The expandable body 30 of this embodiment also includes an expandable main body portion 35, a distal fixing portion 36, and a proximal fixing portion 37. The expandable main body portion 35 covers the outer periphery of the protruding portion 15 of the first tubular body 10 in the radial direction C. The expandable main body portion 35 is expandable and contractible in the radial direction C on the outer side of the protruding portion 15 of the first tubular body 10 in the radial direction C. The distal fixing portion 36 is continuous with the distal side of the expandable main body portion 35. The distal fixing portion 36 is fixed to the outer surface of the distal end portion 15a of the protruding portion 15 of the first tubular body 10 by adhesive or the like. The distal fixing portion 36 does not expand or contract in the radial direction C. The proximal fixing portion 37 is connected to the proximal side of the expansion main body portion 35. The proximal fixing portion 37 is fixed to the outer surface of the distal end portion 20a of the second tubular body 20 (described later) by adhesive or the like. The proximal fixing portion 37 does not expand or contract in the radial direction C. The light-transmitting window portion 31 and the viewing window portion 38 of the expansion body 30 described above are provided in the expansion main body portion 35. More specifically, the light-transmitting window portion 31 of the expansion body 30 is provided in the peripheral wall portion 35a of the expansion main body portion 35, which is substantially cylindrical in the expanded state. In contrast, the viewing window portion 38 of the expansion body 30 is provided in the tapered portion 35b of the expansion main body portion 35, which is connected to the proximal side of the peripheral wall portion 35a and is tapered in diameter toward the removal direction A2 in the expanded state. By arranging the light-transmitting window portion 31 and the viewing window portion 38 of the expansion body 30 in this manner, it becomes easier to monitor the light-transmitting window portion 31 and the diseased area that this light-transmitting window portion 31 comes into contact with through the viewing window portion 38 using the endoscopic device 101 (see Figure 1).

[0065] The viewing window portion 38 may be a window portion that is continuous endlessly over the entire area in the circumferential direction B, or may be a window portion that is provided only in a part of the circumferential direction B.

[0066] Furthermore, the viewing window portion 38 in this embodiment is configured by the base body 91a, similar to the light-transmitting window portion 31, but may have a different configuration as long as it is configured to be visible through the endoscope device 101.

[0067] As shown in Figures 3 and 4, in the expansion body 30 of this embodiment, the thickness T1 of the covering layer 91b is thinned at the boundary positions BL1 and BL2 between the light-transmitting window portion 31 and the light-shielding portion 32, but the thickness T1 of the covering layer 91b may also be thinned at the boundary position between the viewing window portion 38 and the light-shielding portion 32.

[0068] As shown in FIG. 2 , the second tubular body 20 covers the circumference of the first tubular body 10 in the radial direction C. More specifically, as described above, the first tubular body 10 of this embodiment includes the protrusion 15 that protrudes further distally from the distal end 20a1 of the second tubular body 20. The first tubular body 10 of this embodiment also includes the protrusion 16 that protrudes further proximally from the proximal end 20b1 of the second tubular body 20. The first tubular body 10 and the second tubular body 20 are concentrically arranged. Although the first tubular body 10 and the second tubular body 20 of this embodiment are fixed to the hub 40 so as to be concentric, this configuration is not limiting. For example, the first tubular body 10 and the second tubular body 20 may be directly connected to each other by a connecting portion that connects the outer surface of the first tubular body 10 and the inner surface of the second tubular body 20 in a concentric positional relationship.

[0069] The expandable body 30 of this embodiment spans the outer surface of the first tubular body 10 and the outer surface of the second tubular body 20 and is fixed to the outer surface of the first tubular body 10 and the outer surface of the second tubular body 20. More specifically, the balloon serving as the expandable body 30 of this embodiment includes, as described above, an expansion main body portion 35, a distal fixing portion 36, and a proximal fixing portion 37. The distal fixing portion 36 is fixed to the outer surface of the distal end portion 15a of the protruding portion 15 of the first tubular body 10 by adhesive or the like. The proximal fixing portion 37 is fixed to the outer surface of the distal end portion 20a of the second tubular body 20 by adhesive or the like.

[0070] The expandable body 30 of this embodiment is fixed to the first tubular body 10 and the second tubular body 20 so as to be concentric with the first tubular body 10 and the second tubular body 20 in the expanded state. However, the expandable body 30 does not have to be concentric with the first tubular body 10 and the second tubular body 20 in the expanded state. In other words, the expandable body 30 may be fixed to the first tubular body 10 and the second tubular body 20 so as to be eccentric in that its central axis does not coincide with those of the first tubular body 10 and the second tubular body 20 in the expanded state.

[0071] A fluid flow path 21 is defined between the first tubular body 10 and the second tubular body 20. The fluid is supplied to a fluid storage space 30a defined between the expandable body 30 and the outer surface of the first tubular body 10. The fluid supplied to the fluid storage space 30a may be a liquid, such as saline, or a gas, such as air. The flow path 21 has a distal opening 21a at the distal end 20a1 of the second tubular body 20, and communicates with the fluid storage space 30a through this distal opening 21a. The flow path 21 also has a proximal opening 21b that communicates with an internal hub flow path 40b defined by the hub 40 (described below). In other words, fluid is supplied to the fluid storage space 30a through the flow path 21 from the internal hub flow path 40b of the hub 40. Conversely, fluid is discharged from the fluid storage space 30a through the flow path 21 through the internal hub flow path 40b of the hub 40.

[0072] The material for forming the second tubular body 20 is not particularly limited, and may be, for example, a resin material. Examples of resin materials for forming the second tubular body 20 include the materials listed above as examples of materials for forming the first tubular body 10. The second tubular body 20 may also be a metal such as stainless steel, iron, a nickel-titanium alloy, or aluminum. The second tubular body 20 may also be a braided tube reinforced by embedding a metal braided wire in a resin tube, a catheter reinforced by embedding a metal coil, a hypotube, or the like.

[0073] The light irradiation device 1 of this embodiment has a double-tube structure including a first tubular body 10 and a second tubular body 20 arranged concentrically, but is not limited to this configuration. The light irradiation device 1 may have a configuration including the first tubular body 10 but not the second tubular body 20. In such a case, the first tubular body 10 may have, in addition to the storage space 10a, another lumen capable of supplying fluid to the expandable body 30. Furthermore, the cross-sectional outer shape perpendicular to the central axial direction A of the expandable body 30 in the expanded state is not limited to the circle of this embodiment, and may be, for example, an ellipse or a polygon such as a hexagon or octagon.

[0074] 2 , the light irradiation device 1 may include a hub 40. The hub 40 of this embodiment is attached to the proximal end 20b of the second tubular body 20. The hub 40 of this embodiment also holds the protruding portion 16 of the first tubular body 10, which protrudes proximally from the second tubular body 20, so that the first tubular body 10 and the second tubular body 20 are concentric. Furthermore, the hub 40 holds the protruding portion 16 of the first tubular body 10 so that the light irradiator 201 can be inserted into the proximal opening 10a1 of the accommodation space 10a of the first tubular body 10.

[0075] As shown in Figure 2, the hub 40 includes a hub body 41 and a connecting portion 42 that is threadedly engaged with the hub body 41. The hub body 41 includes a port portion 40a to which a fluid supply device 105 (see Figure 1) such as a syringe can be connected. By connecting the fluid supply device 105 to the port portion 40a, fluid can be supplied to the fluid storage space 30a of the expandable body 30 through the hub internal flow path 40b and the flow path 21.

[0076] The connecting portion 42 holds the light irradiator 201 so as to surround it. The connecting portion 42 is connected to the hub body 41 by screwing when the light irradiator 201 is inserted into the accommodation space 10a of the first tubular body 10. This fixes the relative positions of the light irradiator 201 and the light irradiation device 1 in the central axis direction A. Conversely, by releasing the screwing between the hub body 41 and the connecting portion 42, the light irradiator 201 can be removed from the first tubular body 10 of the light irradiation device 1.

[0077] 2 , the light irradiation device 1 may include an operation unit 50. The operation unit 50 may be fixed on the outer surface of the second tubular body 20. An operator of the light irradiation device 1 can move the light irradiation device 1 in the central axis direction A and rotate the light irradiation device 1 in the circumferential direction B by holding and operating the operation unit 50.

[0078] As shown in Fig. 2 , the light irradiation device 1 may include a fixing portion 60. As shown in Fig. 1 , the fixing portion 60 is used to fix the light irradiation device 1 to an endoscope apparatus 101 (see Fig. 1 ). More specifically, the light irradiation device 1 of this embodiment can be attached to the endoscope apparatus 101 by fixing the fixing portion 60 to the endoscope apparatus 101 with the portion of the light irradiation device 1 distal to the fixing portion 60 inserted into a treatment tool channel of the endoscope apparatus 101.

[0079] As shown in FIGS. 2 and 4 , the light irradiation device 1 may include a marker portion 70. The marker portion 70 may be made of, for example, a metal with high radiopacity, such as platinum, gold, iridium, or tungsten, which has radiographic contrast. The marker portion 70 is arranged at a position overlapping the light-transmitting window portion 31 of the expansion body 30 in the circumferential direction B. By providing such a marker portion 70, the position of the light-transmitting window portion 31 of the light irradiation device 1 in the circumferential direction B can be confirmed through an X-ray image. The arrangement position of the marker portion 70 in the central axis direction A is not particularly limited. The marker portion 70 may be attached to, for example, the outer surface of the first tubular body 10. As shown in FIGS. 2 and 4 , the marker portion 70 may be attached to, for example, the outer surface of the first tubular body 10 at a position overlapping the proximal fixing portion 37 of the expansion body 30 in the central axis direction A.

[0080] As shown in Figures 2 and 4, the light irradiation device 1 may include a distal protection part 80. The distal protection part 80 constitutes the distal end of the light irradiation device 1. The distal protection part 80 may be made of, for example, an elastic material. As shown in Figures 2 and 4, the distal protection part 80 may be fixed to the distal end of the first tubular body 10. By providing such a distal protection part 80, it is possible to prevent the distal end of the light irradiation device 1 from damaging biological tissue surrounding the lumen.

[0081] Finally, referring to FIG. 5 , an example of a method for forming the covering edge portion 91b2 (see FIG. 3 ) in the expandable body 30 serving as the insert 2 of this embodiment will be described. As shown in FIG. 5 , a masking member 300 is used to cover and mask the outer surface of the base body 91a at a position that will become the light-transmitting window portion 31 (see FIG. 3 ). In this state, a coating material 301 that forms the covering layer 91b is applied to the outer surface of the base body 91a by a dipping method or the like. After the coating material 301 has solidified, the masking member 300 is peeled off from the outer surface of the base body 91a. As a result, the position that was covered by the masking member 300 becomes the light-transmitting portion 2a (see FIG. 3 ) where the base body 91a is not covered with the covering layer 91b. In contrast, the position that is not covered by the masking member 300 becomes the light-transmitting limiting portion 2b (see FIG. 3 ) where the outer surface of the base body 91a is covered with the covering layer 91b.

[0082] As shown in Figure 5, immediately after applying the coating material 301 forming the coating layer 91b to the outer surface of the base body 91a, the position of the expandable body 30 in the circumferential direction E is adjusted so that the portion where the masking member 300 is located faces vertically upward. By maintaining this state, the fluid coating material 301 before solidification tends to move vertically downward due to gravity G at a position adjacent to the masking member 300 in the circumferential direction E. Therefore, as shown in Figure 5, a coating edge portion 91b2 can be formed in which the thickness of the coating layer 91b gradually decreases toward the boundary position BL1 at the position that becomes the light-transmitting portion 2a covered by the masking member 300 and at a position adjacent to the position in the circumferential direction E. Although gravity G is used in Figure 5, the coating edge portion 91b2 may also be formed using, for example, an external force other than gravity G.

[0083] Furthermore, by forming the coated edge portion 91b2 using the method shown in Figure 5, when peeling off the masking member 300, it is possible to prevent the coating material 301 applied to a position adjacent to the masking member 300 in the circumferential direction E from being unintentionally peeled off along with the peeling off of the end of the masking member 300 in the circumferential direction E.

[0084] The method for forming the covering edge portion 91b2 shown in Fig. 5 is one example, and the covering edge portion 91b2 may be formed by other methods. Also, the covering edge portion 91b4 (see Fig. 4) adjacent to the light transmitting portion 2a in the central axis direction D can be formed by utilizing gravity G as in Fig. 5, but the method for forming the covering edge portion 91b4 is not limited to this method.

[0085] The biological insertion device according to the present disclosure is not limited to the specific configuration shown in the above-described embodiment, and various modifications, alterations, and combinations are possible without departing from the scope of the claims. The light irradiation device 1 as the biological insertion device of the above-described embodiment includes a first tubular body 10, a second tubular body 20, an expansion body 30, a hub 40, an operation unit 50, a fixing unit 60, a marker unit 70, and a distal protection unit 80, but is not limited to this configuration. For example, the light irradiation device 1 may include a single tubular body that separates the storage space 10a and the flow path 21, instead of the first tubular body 10 and the second tubular body 20. Furthermore, the light irradiation device 1 may not include any of the first tubular body 10, the second tubular body 20, the expansion body 30, the hub 40, the operation unit 50, the fixing unit 60, the marker unit 70, and the distal protection unit 80, or may further include other components.

[0086] The present disclosure relates to a bioinsertion device.

[0087] 1: Light irradiation device (an example of a living body insertion device) 2: Insertion body 2a: Light transmission portion 2b: Light transmission limiting portion 10: First tubular body 10a: Storage space 10a1: Proximal opening 15: Distal protrusion 15a: Distal end portion 15b: Closure wall 16: Proximal protrusion 20: Second tubular body 20a: Distal end portion 20a1: Distal end 20b: Proximal end portion 20b1: Proximal end 21: Flow path 21a: Distal opening 21b: Proximal opening 30: Expansion body (an example of an insertion body) 30a: Fluid storage space 31: Light transmission window portion (an example of a light transmission portion) 32: Light blocking portion (an example of a light transmission limiting portion) 35: Expansion main body portion 35a: Circumferential wall portion 35b: Tapered portion 36: Distal side fixing portion 37: Proximal side fixing portion 38: Viewing window portion 40: Hub 40a: Port portion 40b: Hub internal flow path 41: Hub body 42: Connection portion 50: Operation portion 60: Fixing portion 70: Marker portion 80: Distal protection portion 91a: Base body 91b: Coating layer 91b1: Main coating portion 91b2: Coating edge portion 91b3: Main coating portion 91b4: Coating edge portion 91c: Outer layer 100: Endoscope system 101: Endoscope device 102: Control device 102a: Light source portion 102b: Processor portion 103: Display portion 104: Light source device 105: Fluid supply tool 200: Light irradiation portion 201: Light irradiator 202: Optical transmission member 300: Masking member 301: Coating material A, D: Central axis direction A1: Insertion direction A2: Removal direction B, E: Circumferential direction C, F: Radial direction G: Gravity BL1: Circumferential boundary position between the light transmitting portion and the light transmission limiting portion BL2: Boundary position between the light transmitting portion and the light transmission limiting portion in the central axis direction H1: Maximum height of the outer surface of the light transmission limiting portion from the outer surface of the base body H2: Maximum height of the outer surface of the light transmitting portion from the outer surface of the base body L1: Circumferential length of the covering edge portion adjacent to the light transmitting portion in the circumferential direction L2: Central axis length of the covering edge portion adjacent to the light transmitting portion in the central axis direction O1: Central axis line of the expansion body O2: Central axis line of the first tubular body T1: Thickness of the covering layer T2: Thickness of the base body T3: Thickness of the outer layer θ1, θ2: Angle of contact of the covering edge portion with the light transmitting portion at the boundary position

Claims

1. A biological insertion device comprising: an insert body insertable into a living body and defining a central axis along a direction of insertion into the living body, said insert body comprising: a base body; and a coating layer covering the outside of said base body, said insert body comprising: a light transmission limiting section in which said base body is covered with said coating layer; and a light transmitting section in which said base body is not covered with said coating layer, said light transmission limiting section and said light transmitting section being arranged adjacent to each other, a maximum height of an outer surface of said light transmission limiting section from an outer surface of said base body is higher than a maximum height of an outer surface of said light transmitting section from an outer surface of said base body, and a thickness of said coating layer of said light transmission limiting section is not constant and is thinnest at a boundary position between said light transmission limiting section and said light transmitting section.

2. The bioinsertion device according to claim 1, wherein the light transmission limiting portion and the light transmitting portion are arranged adjacent to each other in the circumferential direction around the central axis, and in a cross-sectional view of a cross section passing through the light transmission limiting portion and the light transmitting portion and perpendicular to the central axis, the thickness of the coating layer of the light transmission limiting portion varies with position in the circumferential direction and is thinnest at a boundary position between the light transmission limiting portion and the light transmitting portion in the circumferential direction.

3. The bioinsertion device according to claim 2, wherein, in the cross-sectional view, the thickness of the coating layer of the light transmission limiting portion gradually decreases from the position of maximum thickness toward the boundary position in the circumferential direction.

4. The bioinsertion device according to claim 3, wherein, in the cross-sectional view, the covering layer of the light transmission limiting portion has a covering edge portion whose thickness continues to decrease as it approaches the boundary position.

5. A biological insertion device as described in any one of claims 1 to 4, wherein the insertion body is an expansion body that can expand and contract in a radial direction around the central axis and that houses or is capable of housing a light irradiation unit therein, the base body is transparent to light from the light irradiation unit, the transmittance of the coating layer for light from the light irradiation unit is lower than the transmittance of the base body for light from the light irradiation unit, and the expansion body is provided with a light-transmitting window portion consisting of the light-transmitting portion, and a light-shielding portion consisting of the light-transmitting limiting portion.

6. The bioinsertion device according to claim 5, wherein the transmittance of said covering layer for the light from said light irradiating unit is lower than each of the reflectance and absorptance of said covering layer for the light from said light irradiating unit.

7. The biological insertion device according to claim 6, wherein the covering layer is a reflector having a reflectance of light from the light irradiating section that is greater than an absorptance of light from the light irradiating section.

8. The bioinsertion device according to claim 5, further comprising a tubular body disposed inside the expandable body, the tubular body defining an internal storage space that contains or can contain the light irradiation unit.

9. A bioinsertion device as described in any one of claims 1 to 4, wherein the light transmission limiting portion and the light transmitting portion are arranged adjacent to each other in a central axial direction along the central axis, and in a cross-sectional view of a cross section parallel to the central axis passing through the light transmission limiting portion and the light transmitting portion, the covering layer of the light transmission limiting portion has a covering edge portion whose thickness gradually decreases as it approaches a boundary position between the light transmission limiting portion and the light transmitting portion in the central axial direction.

10. A bioinsertion device comprising: a balloon provided at a distal end of the bioinsertion device; the balloon comprising: a light-shielding portion having a coating film portion formed on the surface of a base body; and a light-transmitting window portion where the coating film portion is not formed on the surface of the base body; and the thickness of the coating film portion gradually decreases toward a boundary position between the light-shielding portion and the light-transmitting window portion.

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