Balloon catheter

Abstract

The balloon catheter according to the present disclosure includes a tubular member having a long axis; a balloon connected to a distal side in the long axis direction of the tubular member and capable of expanding and contracting in a radial direction around the long axis, the balloon having a light-transmitting window portion in an expanded state, the light-transmitting window portion extending in a circumferential direction around the long axis over a prescribed angle range that does not cover the entire area; and a marker portion indicating a position of the light-transmitting window portion in the circumferential direction.

Description

Technical Field

[0001] This published text relates to balloon catheters. Background Technology

[0002] Balloon catheters for irradiating abnormal tissue with therapeutic light have been known for a long time. Such a balloon catheter is disclosed in Patent Document 1. The balloon catheter of Patent Document 1 includes a balloon with a defined treatment window, into which an optical cable is inserted for use.

[0003] Existing technical documents Patent documents Patent Document 1: Japanese Patent Application Publication No. 2005-46640 Summary of the Invention

[0004] The problem that the invention aims to solve In the technique implemented using the balloon catheter of Patent Document 1, it is assumed that the balloon catheter is inserted into the body while the balloon is in a contracted state, and then the balloon is inflated. Here, in the balloon catheter of Patent Document 1, the treatment window, which serves as the light-transmitting window, sometimes extends circumferentially around the long axis of the tubular member that divides the central channel, within a predetermined angle range that does not cover the entire area. In this case, it is preferable to align the circumferential position of the light-transmitting window with the position of the irradiation target, such as the lesion, before inflating the balloon. However, it is difficult to confirm the circumferential position of the light-transmitting window while the balloon is in a contracted state and inserted into the body.

[0005] The purpose of this disclosure is to provide a balloon catheter that allows for confirmation of the circumferential position of the light-transmitting window even when the balloon is in a contracted state or when the balloon is inserted into a living organism.

[0006] Methods for solving problems The balloon catheter of the first embodiment in this disclosure is as follows. (1) A balloon catheter, which has the following features: Tubular components with a long axis; A balloon, connected to the distal side of the aforementioned tubular member along its long axis, and capable of radially expanding and contracting about the aforementioned long axis, wherein the balloon, in its expanded state, has a light-transmitting window extending circumferentially around the aforementioned long axis within a predetermined angular range that does not cover the entire area; and A marking section that indicates the position of the aforementioned light-transmitting window section in the aforementioned circumferential direction.

[0007] The balloon catheter, as one embodiment of this disclosure, is as follows: (2) As described in (1) above, the balloon catheter, wherein the aforementioned marking portion is a notch formed by cutting off a portion of the aforementioned tubular member or another member mounted on the aforementioned tubular member in the aforementioned circumferential direction.

[0008] The balloon catheter, as one embodiment of this disclosure, is as follows: (3) As described in (2) above, the maximum value of the notch angle in the circumferential direction of the aforementioned notch portion is approximately consistent with the aforementioned specified angle range of the aforementioned light-transmitting window portion.

[0009] The balloon catheter, as one embodiment of this disclosure, is as follows: (4) The balloon catheter described in (2) or (3) above, wherein the shape of the aforementioned notch portion in the aforementioned radial view is substantially the same as the shape of the aforementioned light-transmitting window portion in the aforementioned radial view.

[0010] The balloon catheter, as one embodiment of this disclosure, is as follows: (5) The balloon catheter as described in any one of (2) to (4) above, wherein the aforementioned notch portion differs from the portion of the aforementioned tubular member other than the aforementioned notch portion, or from the portion of the aforementioned other member other than the aforementioned notch portion, in terms of at least one of hue, chroma and lightness.

[0011] The balloon catheter, as one embodiment of this disclosure, is as follows: (6) The balloon catheter as described in any one of (1) to (5) above, wherein the aforementioned marking portion is disposed at the distal end of the aforementioned tubular member in the aforementioned long axis direction.

[0012] The balloon catheter, as one embodiment of this disclosure, is as follows: (7) The balloon catheter as described in any one of (1) to (6) above, wherein, when the aforementioned marking portion is designated as the first marking portion, the balloon catheter has a second marking portion, the second marking portion being disposed at a position different from the aforementioned first marking portion in the aforementioned circumferential direction and being distinguishable from the aforementioned first marking portion.

[0013] The balloon catheter, as one embodiment of this disclosure, is as follows: (8) The balloon catheter as described in any one of (1) to (7) above, wherein the aforementioned light-transmitting window of the aforementioned balloon extends substantially parallel or parallel to the aforementioned long axis direction.

[0014] The balloon catheter, as one embodiment of this disclosure, is as follows: (9) The balloon catheter as described in any one of (1) to (8) above, wherein the balloon has a visual identification window arranged at a distance from the light-transmitting window on the proximal side of the balloon in the long axis direction, which is closer to the light-transmitting window than the light-transmitting window.

[0015] The balloon catheter, as one embodiment of this disclosure, is as follows: (10) The balloon catheter described in (9) above, wherein the aforementioned visual identification window extends at an angle relative to the aforementioned long axis direction compared to the aforementioned light-transmitting window.

[0016] The effects of the invention According to this disclosure, a balloon catheter can be provided that allows for confirmation of the circumferential position of the light-transmitting window even when the balloon is in a contracted state or when the balloon is inserted into a living organism. Attached Figure Description

[0017] [ Figure 1 [A figure illustrating an example of an endoscopic system with a balloon catheter according to an embodiment of the present disclosure.]

[0018] [ Figure 2 To show Figure 1 A three-dimensional view of the area around the balloon in the balloon catheter shown.

[0019] [ Figure 3 To show Figure 1 The cross-sectional view of the balloon catheter near the balloon in a section passing through the long axis of the tubular member and parallel to the direction of the long axis.

[0020] [ Figure 4A ]for Figure 3 A cross-sectional view at the location of line II.

[0021] [ Figure 4B ]for Figure 3 A cross-sectional view at the location of line II-II.

[0022] [ Figure 5A [A diagram showing a modified example of the notch.]

[0023] [ Figure 5B [A diagram showing a modified example of the notch.]

[0024] [ Figure 5C [A diagram showing a modified example of the notch.]

[0025] [ Figure 6A [Figure showing a modified example of a balloon catheter]

[0026] [ Figure 6B [Figure showing a modified example of a balloon catheter]

[0027] [ Figure 6C [Figure showing a modified example of a balloon catheter]

[0028] [ Figure 7 [A diagram showing a modified example of the notch.]

[0029] [ Figure 8A [A perspective view showing a modified example of a tubular member.]

[0030] [ Figure 8B [For radial observation] Figure 8A The top view of the tubular component shown.

[0031] [ Figure 9 [A diagram showing a modified example of the notch.] Detailed Implementation

[0032] Hereinafter, embodiments of the balloon catheter involved in this disclosure will be described by way of example with reference to the accompanying drawings. In each drawing, the same reference numerals are used to label the same components.

[0033] Figure 1 The figure illustrates an example of an endoscope system 100 comprising an embodiment of the balloon catheter involved in this disclosure, namely a balloon catheter 1. Figure 1 The illustrated endoscope system 100 includes: an endoscope device 101; a control device 102 connected to the endoscope device 101; a display unit 103, such as a monitor, connected to the control device 102; a light source device 104 for supplying light such as treatment light or aiming beam; a fluid supply device 105; and a balloon catheter 1. The endoscope device 101 has a treatment device channel through which the balloon catheter 1, as a treatment device, can be inserted. Figure 1 As shown, the balloon catheter 1 is inserted into the treatment instrument channel of the endoscope device 101 and delivered to the lesion site in a lumen such as a biological vessel. The control device 102 includes: a light source unit 102a that supplies illumination light to the endoscope device 101; and a processor unit 102b that performs various image processing on the imaging signals from the endoscope device 101 and converts them into image signals. In addition, the control device 102 may include an input unit such as a keyboard. The display unit 103 can display the images captured by the endoscope device 101 based on the image signals generated by the processor unit 102b of the control device 102. The fluid supply device 105 can supply fluid to the fluid storage space 30a of the balloon 30 (described later).

[0034] Balloon catheter 1 can be used, for example, for photodynamic therapy (PDT) and photoimmunotherapy (PIT) treatments. Balloon catheter 1 can be inserted into lumens such as those in living organisms. Figure 1 As shown, the balloon catheter 1 can be used in conjunction with the endoscope device 101. Furthermore, there is no particular limitation on the luminal area into which the balloon catheter 1 can be inserted. Figure 1 As shown, the balloon catheter 1 can, for example, pass through the treatment instrument channel of an endoscope device 101 inserted into a lumen organ such as the digestive tract (esophagus, stomach, small intestine, large intestine, etc.), urethra, or blood vessels, for the treatment of cancer in the lumen organ.

[0035] like Figure 1 As shown, the balloon catheter 1 has an insertion portion 1a for insertion into a living organism and a hand-side operating portion 1b for operation outside the living organism. The insertion portion 1a includes a tubular member 10, a balloon 30, and a marking portion 50.

[0036] The tubular member 10 has a long axis O. The balloon catheter 1 can be inserted into and withdrawn from the body along the long axis O of the tubular member 10. Hereinafter, for ease of explanation, the direction along the long axis O will be referred to as "long axis direction A". In addition, the side of the balloon catheter 1 located in the long axis direction A is referred to as "distal side" or "distal side of long axis direction A", and the side of the balloon catheter 1 located in the long axis direction A is referred to as "proximal side" or "proximal side of long axis direction A". Furthermore, the direction around the long axis O is referred to as "circumferential B". In addition, the radial direction of the imaginary circle centered on the long axis O is referred to as "radial C".

[0037] Figure 2 A three-dimensional view showing the vicinity of the balloon 30 of the balloon catheter 1. Figure 3 This is a cross-sectional view of the balloon catheter 1 near balloon 30. More specifically, Figure 3 This is a cross-sectional view of the balloon catheter 1 near the balloon 30 in a section passing through the long axis O of the tubular member 10 and parallel to the direction A of the long axis. Figure 4A for Figure 3 A cross-sectional view at the location of line II. Additionally, Figure 4B for Figure 3 A cross-sectional view at the location of line II-II.

[0038] like Figure 2 , Figure 3 As shown, the tubular member 10 has an insertion passage 10a internally for inserting a light irradiator 201. The light irradiator 201 may include: a light irradiation section 200 that irradiates light outward toward the radial direction C; and a light source device 104 (see...) Figure 1A light transmission member 202, such as an optical fiber, transmits therapeutic light or aiming beam to the light irradiation unit 200. In the light irradiator 201 of this embodiment, the light irradiation unit 200 is installed at the distal end of the light transmission member 202. The light irradiator 201 and the balloon catheter 1 are separately provided. In addition, the balloon catheter 1 may have an inner tube with a cavity for insertion of the light irradiator 201 inside the radial direction C of the tubular member 10. In this case, the light irradiator 201 can be inserted into the cavity of the inner tube instead of the insertion passage 10a. The tubular member 10 and the inner tube may be arranged in a concentric circle. The inner tube may extend distally relative to the tubular member 10. The inner tube may also extend proximally relative to the tubular member 10. In this configuration, the gap between the outer surface of the inner tube and the inner surface of the tubular member 10 can be divided into an expansion cavity, which becomes a flow path for supplying or discharging fluid into or out of the fluid receiving space 30a.

[0039] The intensity and wavelength of the light irradiated from the light irradiation unit 200 can be appropriately selected, for example, according to the type of drug used, the condition of the lesion, and its location. The light irradiated from the light irradiation unit 200 can be, for example, visible light such as near-infrared light with a wavelength around 690 nm.

[0040] The insertion passage 10a extends along the long axis direction A. In this embodiment, the insertion passage 10a penetrates the tubular member 10 along the long axis direction A. The insertion passage 10a is connected to the fluid supply space 30a of the balloon 30 (described later) via a distal opening. Therefore, in the balloon catheter 1 of this embodiment, the light irradiator 201 can be inserted from the proximal opening of the insertion passage 10a, through the distal opening of the insertion passage 10a, into the fluid supply space 30a of the balloon 30 (described later).

[0041] In this embodiment, the cross-section of the tubular member 10 orthogonal to the major axis A is circular. However, the shape of the cross-section of the tubular member 10 orthogonal to the major axis A is not particularly limited; for example, it can be elliptical or oval. Similarly, in this embodiment, the cross-section of the insertion passage 10a orthogonal to the major axis A is circular. However, the shape of the cross-section of the insertion passage 10a orthogonal to the major axis A is not particularly limited; for example, it can be elliptical or oval.

[0042] The material for forming the tubular component 10 is not particularly limited. Examples include: polyethylene, polypropylene, ethylene-propylene copolymers and other polyolefins; ethylene-vinyl acetate copolymer (EVA); polyvinyl chloride; polyvinylidene chloride; polystyrene; polyamide; polyamide elastomer; polyimide; polyamide-imide; polycarbonate; poly-(4-methyl-1-pentene); ionomer; acrylic resin; polymethyl methacrylate; acrylonitrile-butadiene-styrene copolymer (ABS resin); acrylonitrile-styrene copolymer (A S resin); butadiene-styrene copolymer; polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycyclohexanediol terephthalate (PCT) and other polyesters; polyether; polyetherketone (PEK); polyetheretherketone (PEEK); polyetherimide; polyoxymethylene (POM); polyphenylene ether; modified polyphenylene ether; polysulfone; polyethersulfone; polyphenylene sulfide; polyarylate; aromatic polyester (liquid crystal polymer); polytetrafluoroethylene, polyvinylidene fluoride, other fluorinated resins; and various other resin materials. Furthermore, the forming material of the tubular member 10 can be a blend containing two or more of these materials. Additionally, the tubular member 10 can be formed from a metallic material.

[0043] The balloon 30 is connected to the distal side of the tubular member 10 in the long axis direction A. The balloon 30 is configured to expand and contract radially C. The balloon 30 of this embodiment has an internally defined fluid receiving space 30a. The fluid receiving space 30a of this embodiment is connected to the insertion passage 10a of the tubular member 10. Therefore, in the balloon catheter 1 of this embodiment, fluid can be supplied to and discharged from the fluid receiving space 30a via the insertion passage 10a. The balloon 30 of this embodiment expands radially outward by supplying fluid to the fluid receiving space 30a. Furthermore, the balloon 30 of this embodiment contracts radially inward by discharging fluid from the fluid receiving space 30a. Figure 2 , Figure 3 In the diagram, the balloon 30 is shown in its expanded state. The fluid supplied to the fluid receiving space 30a can be a liquid such as saline solution or a gas such as air. In this embodiment, the balloon 30 has a central axis that is substantially aligned with the long axis O of the tubular member 10 in its expanded state.

[0044] The balloon 30 is configured to house the light irradiation unit 200 internally. Specifically, the balloon 30 of this embodiment can house the light irradiation unit 200 in a liquid storage space 30a, which serves as the internal space.

[0045] The balloon 30 of this embodiment includes: an expansion main body 34 capable of expanding and contracting in a radial direction C; a proximal tube 35 connected to the proximal side of the expansion main body 34 and fixed to the tubular member 10; and a distal tube 36 connected to the distal side of the expansion main body 34.

[0046] like Figure 2 , Figure 3 As shown, the expanded main body 34 of this embodiment, in its expanded state, includes a central portion 41, a proximal tapering portion 42, and a distal tapering portion 43. The central portion 41 is generally cylindrical and has a side surface formed approximately parallel to the long axis direction A in a cross-section parallel to the long axis direction A. The proximal tapering portion 42 is connected to the proximal side of the central portion 41 in the long axis direction A, and tapers towards the long axis direction A, approaching the long axis O. The distal tapering portion 43 is connected to the distal side of the central portion 41 in the long axis direction A, and tapers towards the long axis direction A, approaching the long axis O. The proximal tapering portion 42 and the distal tapering portion 43 of this embodiment can be configured as hemispherical. However, the shapes of the proximal tapering portion 42 and the distal tapering portion 43 are not limited to hemispherical; for example, they can also be conical.

[0047] The proximal cylindrical portion 35 is connected to the proximal constricted portion 42 of the expanding main body portion 34. The proximal cylindrical portion 35 does not expand or contract in the radial direction C. The proximal cylindrical portion 35 is fixed to the tubular member 10 in such a way that it covers the outer side of the radial direction C of the distal end 11 of the tubular member 10. Specifically, the inner surface of the proximal cylindrical portion 35 is fixed to the outer surface of the distal end 11 of the tubular member 10 by adhesive or the like.

[0048] Furthermore, in this embodiment, the distal end 11 of the tubular member 10 is composed of a narrow diameter portion 12b with an outer diameter smaller than that of the proximal main tube portion 12a. That is, in the tubular member 10, an annular step is formed between the outer surface of the main tube portion 12a and the outer surface of the narrow diameter portion 12b. In this embodiment, the proximal tube portion 35 of the balloon 30 is joined to the outer surface of the narrow diameter portion 12b, which is the distal end 11 of the tubular member 10. The radially outer surface of the proximal tube portion 35 is preferably located further radially inner than the outer surface of the main tube portion 12a of the tubular member 10. Furthermore, more preferably, the radially outer surface of the proximal tube portion 35 is configured to be flush with the outer surface of the main tube portion 12a of the tubular member 10 without forming the aforementioned step. Thus, by ensuring that the proximal tube portion 35 does not protrude further outward in the radial direction C than the outer surface of the main tube portion 12a of the tubular member 10, it is possible to prevent the proximal end face of the proximal tube portion 35 from hooking onto biological tissue or medical devices such as the endoscope device 101 used with the balloon catheter 1 when the balloon catheter 1 moves distally in the long axis direction A. Although the proximal tube portion 35 is preferably configured not to protrude further outward in the radial direction C than the outer surface of the main tube portion 12a of the tubular member 10, the outer surface of the proximal tube portion 35 can also protrude further outward in the radial direction C as long as hooking of the balloon catheter 1 does not occur when the balloon catheter 1 is withdrawn relative to medical devices such as the endoscope device 101. In addition, the distal end 11 of the tubular member 10 can also be fixed to the balloon 30 in such a way as to cover the radial direction C of the proximal tube portion 35 of the balloon 30. In this case, the proximal end of the proximal tubular portion 35 of the balloon 30 can be configured as a narrow diameter portion with an outer diameter smaller than that of the distal portion of the proximal tubular portion 35. Furthermore, the distal end 11 of the tubular member 10 can be joined to the outer surface of this narrow diameter portion. Preferably, the tubular member 10 and the balloon 30 are configured such that the aforementioned step is not formed between the radially outer surface of the distal end 11 of the tubular member 10 and the outer surface of the proximal tubular portion 35 of the balloon 30.

[0049] The distal cylindrical portion 36 is connected to the distal constricted portion 43 of the expanding main body portion 34. The distal cylindrical portion 36 does not expand or contract in the radial direction C. In this embodiment, the distal end of the fluid receiving space 30a is closed by a sealing wall 36a, which serves as the distal end of the distal cylindrical portion 36.

[0050] like Figure 2 , Figure 3As shown, the balloon 30, in its expanded state, includes a light-transmitting window 31 and a light-blocking portion 32. In this embodiment, the light-transmitting window 31 is disposed on the expansion body portion 34 of the balloon 30. Specifically, in this embodiment, the light-transmitting window 31 is disposed only on the central portion 41 of the expansion body portion 34. Therefore, in this embodiment, the light-transmitting window 31 extends substantially parallel or parallel to the long axis direction A. However, the arrangement of the light-transmitting window 31 is not limited; for example, it may be arranged across the central portion 41, and with either the proximal narrowing portion 42 or the distal narrowing portion 43, or it may be arranged across both the central portion 41 and the proximal narrowing portion 42 and the distal narrowing portion 43.

[0051] The light-transmitting window 31 extends along the circumferential direction B within a predetermined angular range that does not cover the entire area. That is, the light-transmitting window 31 is only provided on a portion of the balloon 30 along the circumferential direction B. In this embodiment, the predetermined angular range of the light-transmitting window 31 along the circumferential direction B is 180 degrees. The predetermined angular range of the light-transmitting window 31 along the circumferential direction B refers to the maximum value of the angle θ1 defined by the two straight lines L1 and L2 connecting the two ends 33a and 33b of the light-transmitting window 31 along the circumferential direction B to the major axis O when viewing a cross-section of the balloon 30 parallel to the radial direction C along the major axis direction A (see...). Figure 4A In this embodiment, the angle θ1 of the light-transmitting window 31 does not change with the position of the light-transmitting window 31 in the long axis direction A, but remains approximately constant. Therefore, the predetermined angle range of the light-transmitting window 31 in the circumferential direction B in this embodiment is the angle θ1 at any position of the light-transmitting window 31 in the long axis direction A.

[0052] The light-transmitting window 31 is configured to transmit light from the light irradiation section 200 inserted inside the balloon 30 to the outer side in a radial direction C. On the other hand, the light-shielding section 32 has a lower transmittance of light from the light irradiation section 200 of the light irradiator 201 to the outer side in a radial direction C than the light-transmitting window 31 has.

[0053] The light-shielding part 32 is provided in the area of ​​the balloon 30 other than the light-transmitting window part 31 and the visual identification window part 33 described later. More specifically, the light-shielding part 32 and the light-transmitting window part 31 are arranged adjacent to each other in the long axis direction A and the circumferential direction B.

[0054] In this embodiment, the light-transmitting window 31 and the light-shielding portion 32 of the balloon 30 are achieved through a layered relationship of the substrate 45 and the covering layer 46. Specifically, the balloon 30 of this embodiment includes a substrate 45 and a covering layer 46 coated on the outer surface of the substrate 45. The substrate 45 is made of a light-transmitting material capable of transmitting light from the light irradiation portion 200 inserted into the insertion passage 10a radially outward. The covering layer 46 is made of a light-transmitting restricting material, the transmittance of which for light from the light irradiation portion 200 inserted into the insertion passage 10a radially outward is less than the transmittance of the substrate 45. Regarding the light-transmitting window 31 of the balloon 30 of this embodiment, the substrate 45 is not covered by the covering layer 46, and is only composed of the substrate 45. In contrast, regarding the light-shielding portion 32 of the balloon 30 of this embodiment, the substrate 45 is covered by the covering layer 46, and is composed of the substrate 45 and the covering layer 46.

[0055] In other words, the light-transmitting window 31 of the balloon 30 in this embodiment is the light-transmitting portion 2a of the substrate 45 not covered by the coating layer 46. In addition, the light-shielding portion 32 of the balloon 30 in this embodiment is the light-transmitting limiting portion 2b of the substrate 45 covered by the coating layer 46.

[0056] In this embodiment, the balloon 30, in its inflated state, has a visual identification window 33 disposed at a distance from the light-transmitting window 31 on its proximal side in the long axis direction A, which is further away from the light-transmitting window 31 than the light-transmitting window 31. More specifically, in this embodiment, the visual identification window 33 is disposed at a distance from the light-transmitting window 31 on its proximal side, separated by a light-blocking portion 32. Similar to the light-transmitting window 31, the visual identification window 33 in this embodiment is a light-transmitting portion 2a of the substrate 45 that is not covered by the coating layer 46. By providing such a visual identification window 33, even when the balloon catheter 1 is inserted into the body, the surgeon can use the endoscope device 101 to visually identify objects such as lesions through the visual identification window 33 and the light-transmitting window 31. Therefore, when the balloon catheter 1 is inserted into the body, it is easy to align the position of the light-transmitting window 31 of the balloon 30 with the position of the irradiated object in the long axis direction A and the circumferential direction B.

[0057] In this embodiment, the visual identification window 33 is disposed only in the proximal narrowing portion 42. Therefore, in this embodiment, the visual identification window 33 extends at an angle to the light-transmitting window 31 with respect to the long axis direction A. However, the arrangement of the visual identification window 33 is not limited; for example, it can be arranged to span both the central portion 41 and the proximal narrowing portion 42. Furthermore, in this embodiment, the visual identification window 33 is disposed over the entire circumferential region B of the balloon 30, but the visual identification window 33 may also be disposed only in a portion of the balloon 30 in the circumferential direction B.

[0058] In this embodiment, the coating layer 46 can be, for example, a coating material applied to the outer surface of the substrate 45, and there is no particular limitation on the coating method for the outer surface of the substrate 45. The coating material constituting the coating layer 46 can be applied to the outer surface of the substrate 45 by means of dipping, spraying, roller coating, screen printing, vacuum evaporation, low vacuum sputtering, etc.

[0059] In this embodiment, the substrate 45 is made of a transparent resin material. Thus, the substrate 45 can be made of a transparent resin material that is also a light-transmitting material. Examples of resin materials constituting the substrate 45 include polyethylene terephthalate (PET), polyurethane, polyamide, and polyamide elastomers. The substrate 45 can be made of a single layer of transparent resin material or it can be a laminate composed of multiple layers of transparent resin material.

[0060] The constituent materials of the coating layer 46 are not particularly limited. For example, various metallic materials such as titanium oxide, barium sulfate, zinc oxide, silver, and aluminum can be used. Alternatively, the coating layer 46 can also be a resin containing particles of the aforementioned metallic materials, pigments such as carbon black, and dyes.

[0061] In this embodiment, the proximal tubular portion 35 is made of a transparent resin material. Specifically, in this embodiment, the proximal tubular portion 35 is configured as a light-transmitting portion 2a not covered by the coating layer 46 on the substrate 45. Therefore, in the balloon of this embodiment, the distal end 11 and the marking portion 50 of the tubular member 10, which is covered by the proximal tubular portion 35 on the radially outer side C, can be visually identified through the proximal tubular portion 35. In this embodiment, the distal tubular portion 36 is also configured as a light-transmitting portion 2a, similar to the proximal tubular portion 35.

[0062] In the balloon of this embodiment, the area other than the light-transmitting window 31, the visual identification window 33, the proximal tube 35, and the distal tube 36 becomes the light-transmitting restriction portion 2b of the substrate 45 covered by the coating layer 46. However, the balloon 30 is not limited to this configuration. For example, in addition to the light-transmitting window 31, the visual identification window 33, the proximal tube 35, and the distal tube 36, it may also have a light-transmitting portion 2a of the substrate 45 not covered by the coating layer 46.

[0063] The marking section 50 indicates the position of the light-transmitting window section 31 in the circumferential direction B. This detail will be described later.

[0064] Next, an example of the method of using the balloon catheter 1 will be described. First, the light irradiator 201 is inserted into the insertion passage 10a of the tubular member 10 of the balloon catheter 1, with the distal side facing the long axis direction A, and the light irradiator 200 is positioned at a predetermined position within the balloon 30. The predetermined position, for example, means a position in which the light irradiator 200 overlaps with the entire area of ​​the light-transmitting window 31 in the long axis direction A. The balloon 30 of the balloon catheter 1 is in a contracted state in this condition.

[0065] Then, the balloon catheter 1 and the light irradiator 201 inserted into the balloon catheter 1 are inserted into the biological body through the treatment instrument channel of the endoscope device 101. At this time, the position of the light-transmitting window 31 of the balloon 30 is aligned with the position of the irradiation target, such as the lesion site formed in the biological tissue that divides the lumen, in the long axis direction A and the circumferential direction B. Regarding the alignment with the irradiation target in the long axis direction A and the circumferential direction B, one or both are performed as needed. Alignment in the long axis direction A is performed by moving the balloon catheter 1 to the distal or proximal side of the long axis direction A. Alignment in the circumferential direction B is performed by rotating the balloon catheter 1 around the circumferential direction B. The circumferential alignment in B can be performed when the balloon 30 of the light irradiation device 1 changes from a contracted state to a first expansion state, which is an expansion amount adjusted to a degree that does not contact the inner wall of the irradiation target, such as the lesion site, or the irradiation target, or a degree of slight contact, i.e., a first expansion amount. More specifically, the alignment with the irradiated object, such as the lesion site, can be performed while the light-transmitting window 31 of the balloon 30 in the first expansion state can be observed through the visual recognition window 33.

[0066] Then, the balloon 30 is expanded from a contracted state to an expanded state, thereby bringing the light-transmitting window 31 close to or in contact with the irradiated object, such as the lesion. With the balloon 30 in its first expanded state, it is then expanded to a second expansion amount greater than the first expansion amount, resulting in a second expanded state where the light-transmitting window 31 is close to or in contact with the irradiated object, such as the lesion. Here, the aforementioned expanded state and the second expanded state are the same. In the expanded state (second expanded state), the operation of positioning the light irradiation unit 200 at a predetermined position (alignment) in the long axis direction A can be performed again. By making the balloon 30 in the expanded state (second expanded state), the light-transmitting window 31 of the balloon 30 is brought into contact with the irradiated object. In this state, light irradiated from the light irradiation unit 200 and transmitted radially outward from the light-transmitting window 31 can be irradiated onto the irradiated object. By bringing the light-transmitting window 31 close to or in contact with the irradiated object, such as the lesion, light irradiation of the irradiated object can be performed more reliably. Furthermore, the visual recognition window 33 and the light-transmitting window 31 allow for clearer visual identification of the irradiated object, such as the lesion, while also preventing the balloon 30 from shifting position during treatment. The step of irradiating the irradiated object with light from the light irradiation unit 200 and transmitted radially outward from the light-transmitting window 31 can be repeatedly performed. In this case, after the balloon 30 is in a contracted state or a first expanded state and repositioned with the irradiated object, such as the lesion, it is then placed in an expanded state or a second expanded state before irradiating the object.

[0067] Furthermore, the arrangement of the light irradiator 201 into the insertion passage 10a can be performed after the balloon 30 has expanded from a contracted state to a first expanded state or to a second expanded state. By arranging the light irradiator 201 in the insertion passage 10a while the balloon 30 is in an expanded state, it is possible to prevent the light irradiator 201 from bending or breaking when the light irradiation device 1 is inserted into the biological body via the treatment instrument channel 101a of the endoscope device 101.

[0068] After treatment, the balloon 30 is in a contracted state, and the balloon catheter 1 and the light irradiation body 201 are pulled out of the body through the treatment instrument channel of the endoscope device 101.

[0069] Next, refer to Figures 2 to 4B The details of the marking section 50 in this embodiment will be explained.

[0070] As described above, the marker 50 indicates the position of the light-transmitting window 31 in the circumferential direction B. By providing such a marker 50, even when the balloon 30 is in a contracted state or when the balloon 30 of the balloon catheter 1 is inserted into the body, the surgeon can visually identify the marker 50 using the endoscope device 101, thereby confirming the position of the light-transmitting window 31 in the circumferential direction B.

[0071] In this embodiment, the position of the marking portion 50 on the circumferential B is approximately the same as the position of the light-transmitting window portion 31 on the circumferential B. By visually identifying the marking portion 50 in this way, the position of the light-transmitting window portion 31 on the circumferential B can be easily confirmed.

[0072] In this embodiment, the marking portion 50 is disposed at the distal end 11 of the tubular member 10 in the long axis direction A. In this way, the marking portion 50 can be easily visually identified by means of the endoscope device 101.

[0073] like Figure 2 , Figure 3 , Figure 4B As shown, the marking portion 50 in this embodiment is a notch 15 formed by cutting off a portion of the tubular member 10 in the circumferential direction B. Here, "cutting off the tubular member 10" means cutting off or removing a portion of the tubular member 10. In this way, the marking portion 50 indicating the position of the light-transmitting window portion 31 in the circumferential direction B can be easily realized. In addition, since it is not necessary to add components to the balloon catheter 1, the configuration of the balloon catheter 1 can be simplified.

[0074] In this embodiment, the notch 15 is formed by cutting away a portion of the tubular member 10 along its long axis A. Furthermore, in this embodiment, the notch 15 extends along its long axis A from the distal end of the tubular member 10 to a predetermined position further distal than the proximal end of the tubular member 10. That is, the distal end 15b of the notch 15 in this embodiment coincides with the distal end of the tubular member 10. However, the distal end 15b of the notch 15 may not coincide with the distal end of the tubular member 10. Additionally, in this embodiment, the notch 15 is formed only in the portion of the distal end 11 of the tubular member 10 covered by the proximal tubular portion 35 of the balloon 30, but the notch 15 may also be formed in the portion of the distal end 11 of the tubular member 10 not covered by the proximal tubular portion 35 of the balloon 30. However, by forming the notch 15 only in the distal end 11 of the tubular member 10, as in this embodiment, and covering the proximal tube portion 35 of the balloon 30, it is possible to suppress leakage of fluid from the notch 15 into the fluid supply space 30a supplied to the balloon 30.

[0075] Regarding the notch 15 in this embodiment, the notch angle θ2 in the circumferential direction B gradually decreases from the distal end 15b to the proximal end 15a. That is, in the notch 15 of this embodiment, the notch angle θ2 is the largest at the distal end 15b and the smallest at the proximal end 15a. The notch angle θ2 at the distal end 15b of the notch 15 in this embodiment is 180 degrees. The notch angle θ2 at the proximal end 15a of the notch 15 in this embodiment is 0 degrees. The notch angle θ2 refers to the angle defined by the two straight lines L3 and L4 connecting the two ends 16a and 16b of the notch 15 in the circumferential direction B to the major axis O in the cross section of the tubular member 10 parallel to the radial direction C (see [reference]). Figure 4B ).

[0076] As described above, the light-transmitting window 31 extends along the circumferential direction B within a predetermined angle range that does not cover the entire area. Here, the maximum value of the notch angle θ2 of the notch 15 in the circumferential direction B in this embodiment is approximately consistent with the aforementioned predetermined angle range of the light-transmitting window 31. Furthermore, in the cross-section of the tubular member 10 parallel to the radial direction C, the bisector of the notch angle θ2 of the notch 15 in the circumferential direction B in this embodiment intersects with the aforementioned angle θ1 of the light-transmitting window 31 in this embodiment (see...). Figure 4A The bisector of the notch 31 is approximately the same when viewed from the major axis direction A. In this way, the position of the light-transmitting window 31 in the circumferential direction B can be easily confirmed by visually identifying the marking part 50. In this embodiment, the aforementioned predetermined angle range of the light-transmitting window 31 in the circumferential direction B is 180 degrees as described above, and the maximum value of the notch angle θ2 of the notch 15 in the circumferential direction B is also 180 degrees as described above, and the two are consistent. In addition, in this embodiment, in the cross section of the tubular member 10 parallel to the radial direction C, the bisector of the aforementioned predetermined angle range (180 degrees) of the light-transmitting window 31 in the circumferential direction B and the bisector of the notch angle θ2 (180 degrees) of the notch 15 in the circumferential direction B are approximately the same when viewed from the major axis direction A. However, as long as the position of the light-transmitting window 31 in the circumferential direction B can be confirmed by visually identifying the marking part 50, the maximum value of the notch angle θ2 of the notch 15 in the circumferential direction B may not be approximately the same as the aforementioned predetermined angle range of the light-transmitting window 31. More specifically, in the section of the tubular member 10 parallel to the radial direction C, the bisector of the notch angle θ2 of the notch 15 in the circumferential direction B intersects the light-transmitting window 31 at an angle θ1 (see...). Figure 4A When the bisectors of the notch 15 are approximately the same when viewed from the major axis direction A, the maximum value of the notch angle θ2 of the notch 15 in the circumferential direction B may not be approximately the same as the specified angle range of the light-transmitting window 31.

[0077] The shape of the notch 15 is not limited to Figure 2 , Figure 3 , Figure 4B The shape shown. Figures 5A to 5C A diagram illustrating a modified example of the notch 15. (See diagram below.) Figure 5A As shown, regarding the notch 15, the notch angle θ2 in the circumferential direction B can be constant from the distal end 15b to the proximal end 15a. Furthermore, as... Figure 5B As shown, the notch 15 may be a portion formed by cutting away the entire circumferential region B of the tubular member 10. Furthermore, as... Figure 5C As shown, the notch 15 can be a hole formed on the outer surface of the tubular member 10.

[0078] Figures 6A to 6C A diagram illustrating a modified example of balloon catheter 1. Figures 6A to 6C The image shows the state of balloon catheter 1 as viewed radially from point C. (See image for reference.) Figures 6A to 6C As shown, the shape of the notch 15 in the front view taken from radial C is approximately the same as and similar to the shape of the light-transmitting window 31 in the front view taken from radial C. In this way, the surgeon can visually identify the notch 15 formed in the tubular member 10 before inserting the balloon catheter 1 into the body, thereby confirming the shape of the light-transmitting window 31 without inflating the balloon 30. Furthermore, even with the balloon 30 of the balloon catheter 1 inserted into the body, the surgeon can visually identify the notch 15 formed in the tubular member 10 using the endoscope 101, thereby confirming the shape of the light-transmitting window 31. Figure 6A In the example shown, the notch 15 and the light-transmitting window 31, both viewed from the radial direction C in the front view, are approximately rectangular. Furthermore, in Figure 6B In the example shown, the notch 15 and the light-transmitting window 31, both viewed from the radial direction C in the front view, are approximately elliptical. Furthermore, in Figure 6C In the example shown, the shapes of the notch 15 and the light-transmitting window 31 in the front view viewed from radial C are both approximately circular. However, the shapes of the notch 15 and the light-transmitting window 31 in the front view viewed from radial C are not limited to... Figures 6A to 6C The shape shown.

[0079] Figure 7 A diagram illustrating another variation of the notch 15. (See figure below.) Figure 7 As shown, the notch 15 and the portions of the tubular member 10 other than the notch 15 may differ in at least one of hue, chroma, and lightness. In this way, the visual recognizability of the notch 15 can be further improved. Figure 7 In the example shown, the notch 15 differs from the portions of the tubular member 10 other than the notch 15 in terms of hue and lightness. (As will be described later.) Figure 9 In the modified example shown, when another component is mounted on the tubular component 10 and a notch 15 is formed on the other component, the notch 15 and the other component other than the notch 15 may differ in at least one of hue, chroma and lightness.

[0080] Figure 8A A perspective view showing a modified example of the tubular member 10. Figure 8B To observe from radial C Figure 8A The top view of the tubular component shown. Figure 8A , Figure 8B The tubular member 10 shown has the same as Figure 2 , Figure 3 The marking portion 50 shown is different from the marking portion 50. That is, Figure 8A , Figure 8B The tubular member 10 shown has two marking portions 50. For ease of explanation, it will be compared with... Figure 2 , Figure 3 The marking portion 50 shown is the same as the marking portion 50. One marking portion 50 is referred to as "first marking portion 50a", and the other marking portion 50 is referred to as "second marking portion 50b".

[0081] like Figure 8A , Figure 8B As shown, the second marking portion 50b is positioned differently from the first marking portion 50a in the circumferential direction B, and is configured to be distinguishable from the first marking portion 50a. By providing such a second marking portion 50b, even when the field of view of the endoscope device 101 is limited to a portion of the tubular member 10 in the circumferential direction B, and the first marking portion 50a is outside the field of view of the endoscope device 101, the position of the light-transmitting window portion 31 in the circumferential direction B can be confirmed by visually identifying the second marking portion 50b using the endoscope device 101. Figure 8A , Figure 8B In the example shown, the second marking portion 50b is positioned 180 degrees offset in the circumferential direction B relative to the first marking portion 50a. Furthermore, in Figure 8A , Figure 8B In the example shown, both the first marking portion 50a and the second marking portion 50b are notches 15 formed by cutting off a portion of the tubular member 10 in the circumferential direction B. Figure 8A , Figure 8B In the example shown, the notch 15, which is the first marking portion 50a, has a U-shaped shape in the front view viewed from the radial direction C, while the notch 15, which is the second marking portion 50b, has a circular shape in the front view viewed from the radial direction C. By making the first marking portion 50a and the second marking portion 50b have different shapes in this way, thereby achieving... Figure 8A , Figure 8BIn the example shown, the first marking portion 50a and the second marking portion 50b can be easily identified. The first marking portion 50a and the second marking portion 50b do not need to be different in shape, as long as they can be identified. For example, the first marking portion 50a and the second marking portion 50b can be configured to be different in at least one of hue, chroma, and lightness.

[0082] Figure 9 A diagram illustrating another variation of the notch 15. (See figure below.) Figure 9 As shown, the notch 15 can be formed by cutting away a portion of the circumferential direction B of another component mounted on the tubular member 10. The other component refers to a component that is not integrally formed with the tubular member 10. In this way, the design freedom of the notch 15 can be increased. Figure 9 In the example shown, a cylindrical member 90, as another component, is fitted to the radially outer side of the distal end 11 of the tubular member 10. Furthermore, a hole as a notch 15 is formed on the outer surface of the cylindrical member 90.

[0083] The balloon catheter disclosed herein is not limited to the specific configurations shown in the above embodiments and variations. Various modifications, alterations, and combinations are possible as long as they do not exceed the scope of the claims. Specifically, the marking portion 50 in the above embodiments is a notch 15 formed in the tubular member 10, but the marking portion 50 may also be a coating such as ink applied to the outer surface of the tubular member 10. Furthermore, while the marking portion 50 in the above embodiments is provided on the tubular member 10, the marking portion 50 may also be provided, for example, on the proximal tubular portion 35 of the balloon 30.

[0084] Industrial availability This published text relates to balloon catheters.

[0085] Explanation of reference numerals in the attached figures 1: Balloon catheter 1a: Insertion section 1b: Hand-side operating section 2a: Light-transmitting part 2b: Light-transmitting restriction section 10: Tubular components 10a: Insertion Path 11: The distal end of a tubular member 12a: Main pipe section 12b: Narrow diameter section 15: Notch 15a: Proximal end of the notch 15b: Distal end of the notch 16a: In a section parallel to the radial direction, the notch is located at one end in the circumferential direction. 16b: In a section parallel to the radial direction, the notch is at the other end in the circumferential direction. 30: Balloon 30a: Fluid storage space 31: Light-transmitting window 31a: In a section parallel to the radial direction, one end of the light-transmitting window in the circumferential direction 31b: In a section parallel to the radial direction, the other end of the light-transmitting window in the circumferential direction 32: Shading part 33: Visual identification window 34: Expand the main body 35: Near cylinder part 36: Distal cylindrical section 36a: Closed wall 41: Central Department 42: Proximal diameter reduction part 43: Distal diameter reduction 45: Matrix 46: Covering layer 50: Marking section 50a: First Marking Section 50b: Second Marking Section 100: Endoscopic System 101: Endoscopic device 102: Control device 102a: Light source section 102b: Processor Section 103: Display Section 104: Light source device 105: Fluid supply equipment 200: Light irradiation part 201: Light irradiation object 202: Optical transmission component A: Long axis direction B: Zhou Xiang C: Radial O: Major axis of the tubular component

Claims

1. A balloon catheter, which has the following features: Tubular components with a long axis; A balloon, connected to the distal side of the tubular member along its long axis, and capable of radially expanding and contracting about the long axis, the balloon having a light-transmitting window in the expanded state, the light-transmitting window extending circumferentially around the long axis within a predetermined angular range without covering the entire area; and A marking section that indicates the position of the light-transmitting window section in the circumferential direction.

2. The balloon catheter as described in claim 1, wherein, The marking portion is a notch formed by cutting off a portion of the tubular member or another member mounted on the tubular member in the circumferential direction.

3. The balloon catheter as described in claim 2, wherein, The maximum value of the notch angle in the circumferential direction is approximately consistent with the specified angle range of the light-transmitting window.

4. The balloon catheter as described in claim 2 or 3, wherein, The shape of the notch in the radial view is approximately the same as the shape of the light-transmitting window in the radial view.

5. The balloon catheter as described in claim 2 or 3, wherein, The notch portion differs from at least one of the portions of the tubular member other than the notch portion, or from a portion of another member other than the notch portion, in terms of hue, chroma, and lightness.

6. The balloon catheter according to any one of claims 1 to 3, wherein, The marking portion is disposed at the distal end of the tubular member in the direction of its long axis.

7. The balloon catheter according to any one of claims 1 to 3, wherein, When the marking portion is designated as the first marking portion, the balloon catheter has a second marking portion, which is configured at a position different from the first marking portion in the circumferential direction and can be distinguished from the first marking portion.

8. The balloon catheter according to any one of claims 1 to 3, wherein, The light-transmitting window of the balloon extends substantially parallel to or parallel to the long axis direction.

9. The balloon catheter according to any one of claims 1 to 3, wherein, The balloon has a visual identification window arranged at a distance from the light-transmitting window on the proximal side of the balloon, which is closer to the long axis direction than the light-transmitting window.

10. The balloon catheter of claim 9, wherein, The visual recognition window extends at an angle relative to the long axis direction compared to the light-transmitting window.

Images