Temperature measuring device

Abstract

This temperature measurement device is provided with a tube and a temperature sensor unit for measuring temperature. The temperature sensor unit includes a flexible sheet and a plurality of temperature sensor elements that are disposed on the sheet. The temperature sensor unit can be accommodated inside the tube.

Description

[Technical Field]

[0001] The present disclosure relates to a temperature measurement device, and more particularly to a temperature measurement device for measuring the temperature of a tubular organ in a living body. [Background technology]

[0002] Left atrial ablation, which involves cauterizing the myocardium, is a known treatment for atrial fibrillation. However, in left atrial ablation, the heat generated by the ablation is transmitted to the esophagus, which is anatomically close to the heart, potentially causing thermal damage to the esophagus.

[0003] Therefore, a technique for preventing thermal damage to the esophagus by measuring the temperature inside the esophagus is known. For example, Patent Document 1 discloses an esophageal mapping catheter that is placed inside the esophagus and provides feedback to the user by measuring the temperature inside the esophagus during ablation in order to prevent thermal damage to the esophagus. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2010-505592 Summary of the Invention [Problem to be solved by the invention]

[0005] The esophageal mapping catheter described in Patent Document 1 has a thick temperature sensor. When attempting to pack this temperature sensor densely into a hollow instrument such as a catheter, the thick structure creates gaps within the instrument, making it difficult to pack the temperature sensor densely.

[0006] Therefore, an object of the present disclosure is to provide a temperature measuring device having a temperature sensor element that can be accommodated at high density in a limited space inside a pipe. [Means for solving the problem]

[0007] A temperature measurement device according to one aspect of the present disclosure includes a tube and a temperature sensor unit for measuring temperature, the temperature sensor unit including a flexible sheet and a plurality of temperature sensor elements disposed on the sheet, and the temperature sensor unit is housed within the tube. [Effects of the Invention]

[0008] The temperature measurement device according to the present disclosure allows for an increased density of temperature sensor elements housed within a tube. [Brief explanation of the drawings]

[0009] [Figure 1] 1 is a perspective view schematically illustrating an example of the configuration of a temperature measuring device according to a first embodiment. [Figure 2] 2 is a cross-sectional view of the temperature measuring device of FIG. 1, illustrating a typical example of the state in which the temperature sensor unit is accommodated. FIG. [Figure 3] 2 is a cross-sectional view of the temperature measuring device of FIG. 1, illustrating a schematic example of an expanded state of the temperature sensor unit. FIG. [Figure 4] FIG. 10 is a schematic diagram showing a configuration example of the temperature sensor unit in a housed state. [Figure 5] FIG. 10 is a schematic diagram showing an example of the configuration of a temperature sensor unit in an expanded state. [Figure 6] 6 is a schematic cross-sectional view of the temperature sensor unit of FIG. 4 taken along line VI-VI. [Figure 7] FIG. 10 is a schematic diagram showing a state in which a temperature sensor unit is housed in a temperature measuring device according to a second embodiment. [Figure 8] FIG. 10 is a schematic diagram showing the expanded state of a temperature sensor unit in the temperature measuring device according to the second embodiment. [Figure 9A] FIG. 10 is a schematic view showing a state in which a temperature sensor unit is housed in a temperature measuring device according to a third embodiment. [Figure 9B] FIG. 11 is a perspective view schematically showing a state in which a temperature sensor unit is housed in a temperature measuring device according to a third embodiment. [Figure 10A]FIG. 10 is a schematic diagram showing the expanded state of a temperature sensor unit in a temperature measuring device according to a third embodiment. [Figure 10B] FIG. 11 is a perspective view schematically showing an expanded state of a temperature sensor unit in a temperature measuring device according to a third embodiment. [Figure 11] FIG. 10 is a schematic diagram showing a modified example of the temperature sensor unit in the third embodiment. [Figure 12] FIG. 10 is a cross-sectional view schematically showing an example of the configuration of a temperature measuring device according to a fourth embodiment. [Figure 13] FIG. 10 is a cross-sectional view schematically showing an example of the configuration of a temperature measuring device according to a fourth embodiment. [Figure 14] FIG. 10 is a cross-sectional view schematically showing the accommodation state of the temperature sensor unit of the temperature measuring device according to the fifth embodiment. [Figure 15] FIG. 11 is a cross-sectional view schematically showing an expanded state of a temperature sensor unit of a temperature measuring device according to a fifth embodiment. [Figure 16] FIG. 13 is a cross-sectional view schematically showing a deflated state of a balloon of a temperature measuring device according to a modified example of the fifth embodiment. [Figure 17] FIG. 13 is a cross-sectional view schematically showing an intermediate state of a balloon of a temperature measuring device according to a modified example of the fifth embodiment. [Figure 18] FIG. 13 is a cross-sectional view schematically showing an expanded state of a balloon of a temperature measuring device according to a modified example of the fifth embodiment. [Figure 19] FIG. 13 is a side view schematically showing a contracted state of the basket catheter of the temperature measuring device according to the sixth embodiment. [Figure 20] FIG. 13 is a side view schematically showing an expanded state of the basket catheter of the temperature measuring device according to the sixth embodiment. [Figure 21] FIG. 13 is a cross-sectional view schematically showing the accommodation state of the temperature sensor unit of the temperature measuring device according to the sixth embodiment. [Figure 22] FIG. 13 is a cross-sectional view schematically showing an expanded state of a temperature sensor unit of a temperature measuring device according to a sixth embodiment. [Figure 23] FIG. 13 is a schematic diagram showing an example of the configuration of a temperature sensor unit and a balloon of a temperature measuring device according to a seventh embodiment. [Figure 24] 24 is a cross-sectional view of the temperature sensor unit and the balloon taken along line XXIV-XXIV in FIG. 23. [Figure 25] 25 is a schematic diagram showing a cross section of the temperature sensor unit and the balloon in a housed state, corresponding to FIG. 24. FIG. [Figure 26] 26 is a cross-sectional view of the temperature sensor unit and the balloon taken along line XXVI-XXVI in FIG. 23. [Figure 27] 27 is a schematic diagram showing a cross section of the temperature sensor unit and the balloon in a housed state, corresponding to FIG. 26. FIG. [Figure 28] FIG. 13 is a schematic diagram showing an example of the configuration of a temperature sensor unit and a balloon according to a comparative example of the seventh embodiment. [Figure 29] 29 is a cross-sectional view of the temperature sensor unit and the balloon taken along line XXIX-XXIX in FIG. 28. [Figure 30] 30 is a schematic diagram showing a cross section of the temperature sensor unit and the balloon in a housed state, corresponding to FIG. 29. FIG. [Figure 31] FIG. 10 is a schematic diagram illustrating a configuration example of a temperature sensor unit according to a modified example of the embodiment of the present disclosure. [Figure 32] FIG. 10 is a cross-sectional view schematically illustrating an example of the configuration of a temperature measuring device according to another modified example of the embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0010] (Background to this disclosure) The esophageal mapping catheter described in Patent Document 1 has a thick temperature sensor. When attempting to accommodate such temperature sensors at high density in a hollow instrument such as a catheter, the thick structure creates gaps within the instrument, making it difficult to accommodate such sensors at high density.

[0011] The inventors have conducted research to solve the above problems and have come up with a temperature measuring device that can increase the density of temperature sensor elements housed in a tube.

[0012] Hereinafter, embodiments of a temperature measuring device according to the present disclosure will be described with reference to the accompanying drawings. In the following embodiments, identical or similar components are designated by the same reference numerals. Furthermore, in order to facilitate understanding of the description, the shapes, dimensions, positional relationships, etc. of the components may be exaggerated in the accompanying drawings. Furthermore, in order to facilitate understanding of the description, when showing cross-sectional views of the components, illustrations, hatching, etc. of parts other than the cross sections may be omitted in the accompanying drawings.

[0013] (First embodiment) FIG. 1 is a perspective view schematically illustrating an example configuration of a temperature measuring device 1 according to a first embodiment of the present disclosure. The temperature measuring device 1 includes a tubular shaft 10, a temperature sensor unit 100, and a balloon 20. The shaft 10 is an example of a "tube" according to the present disclosure, and the balloon 20 is an example of an "expansion member" according to the present disclosure. For ease of explanation, FIG. 1 illustrates an imaginary axis C indicating the axis of the shaft 10.

[0014] In this specification, the direction parallel to axis C is referred to as the axial direction, the direction perpendicular to axis C as the radial direction, and the circumferential direction centered on axis C as the circumferential direction. Regarding the axial direction, the direction toward the right as you face the paper in FIG. 1 is considered positive. The positive axial direction is also referred to as the distal direction or tip side, and the negative axial direction is also referred to as the proximal direction or base side. Regarding the radial direction, the direction away from axis C is sometimes referred to as the outward direction, and the direction toward axis C is sometimes referred to as the inward direction.

[0015] The shaft 10 is a flexible tube, such as the shaft of a catheter. The shaft 10 has a distal end (tip) 11 and a proximal end (base) 12. The shaft 10 is inserted into a tubular organ in a living body, such as the esophagus. For example, the shaft 10 is inserted from the distal end 11 into the mouth or nose, and then moves into the esophagus.

[0016] The temperature sensor unit 100 has a flexible sheet-like shape, and is housed in the shaft 10 in the housed state shown in FIG.

[0017] In this specification, "flexibility" means, for example, the property of bending due to an external force. Flexibility may include elasticity and rigidity. For example, low rigidity may be expressed as high flexibility. In this specification, "flexibility" includes flexibility. In addition to flexibility, flexibility may also include the property of an object being able to deform freely.

[0018] In this embodiment, the temperature sensor unit 100 is disposed radially between the shaft 10 and the balloon 20 in the housed state. The temperature sensor unit 100 can transition between a housed state in which it is housed within the shaft 10 and a deployed state in which it is deployed outward from the housed state. The housed state and deployed state of the temperature sensor unit 100 will be described below with reference to Figures 2 to 5.

[0019] FIG. 2 is a cross-sectional view of the temperature measuring device 1, illustrating a schematic example of the temperature sensor unit 100 housed therein. The cross-section shown in FIG. 2 is a plane including the axis C. A guide member 30, such as a wire, is connected to the proximal end of the balloon 20. The proximal end of the guide member 30 extends to the outside via the proximal end 12 of the shaft 10. Alternatively, the proximal end of the guide member 30 may extend to the outside via an opening provided on the surface of the shaft 10. A user can move the balloon 20 connected to the guide member 30 in the axial direction by operating the extended guide member 30 by hand, a driving device, or the like. Because a portion of the temperature sensor unit 100 is connected to the balloon 20 by adhesive or the like, the temperature sensor unit 100 can move in the axial direction in conjunction with the movement of the balloon 20 when the balloon 20 moves using the guide member 30.

[0020] The above-described movement of the guide member 30, the balloon 20, and the temperature sensor unit 100 can be performed independently of the shaft 10. Therefore, the guide member 30, the balloon 20, and the temperature sensor unit 100 can move relative to the shaft 10 in the axial direction, and can move further distally from the distal end 11 of the shaft 10 to the outside of the shaft 10.

[0021] The balloon 20 can be reversibly deformed between a contracted state and an expanded state by supplying and discharging gas using a pump or the like via the gas flow path 31. In Figures 2 and 3, the gas flow path 31 is provided inside the guide member 30, but the gas flow path 31 may be provided separately from the guide member 30.

[0022] The balloon 20 is pushed out from the shaft 10 by the guide member 30 and then expands radially outward to an expanded state, thereby spreading out the temperature sensor unit 100. This causes the temperature sensor unit 100 to transition from the housed state shown in FIG. 2 to the deployed state shown in FIG. 3.

[0023] 3 is a cross-sectional view of the temperature measuring device 1, illustrating a schematic example of the deployed state of the temperature sensor unit 100. Compared to the state shown in FIG. 2, in FIG. 3 the balloon 20 and the temperature sensor unit 100 are arranged outside the shaft 10. Also in FIG. 3, the balloon 20 is inflated to an expanded state, and the temperature sensor unit 100 is pushed open by the balloon 20 to an deployed state. In the deployed state, at least one radial dimension R of the temperature sensor unit 100 is larger than the inner diameter r of the shaft 10.

[0024] With this configuration, the temperature sensor unit 100, in the deployed state, can come into contact with the inner wall of a tubular organ in a living body, such as the esophagus.

[0025] 4 and 5 are schematic diagrams showing an example of the configuration of the temperature sensor unit 100. For ease of explanation, FIGS. 4 and 5 show an X-axis, a Y-axis, and a Z-axis that are orthogonal to each other. In this specification, the direction of the X-axis may be referred to as the row direction, and the direction of the Y-axis as the column direction. In this embodiment, the direction of the X-axis coincides with the direction of axis C in FIG. 1, and the direction of the Z-axis coincides with the radial direction.

[0026] 4 is a schematic diagram of the temperature sensor unit 100 in a housed state. The temperature sensor unit 100 has a sheet 101 and a plurality of temperature sensor elements 110 arranged on the sheet 101.

[0027] The sheet 101 is flexible and has a shape that expands in the X and Y directions. In Fig. 4, the Y direction indicates the circumferential direction. Although not shown in Fig. 4, the sheet 101 further extends in the Y direction in Fig. 4, and the upper and lower ends of the sheet 101 in Fig. 4 are connected to each other, giving the sheet 101 an overall cylindrical shape. The sheet 101 includes, for example, polyimide, liquid crystal polymer, polyethylene terephthalate, silicone, polyurethane, polyether block amide, or a combination thereof.

[0028] The temperature sensor element 110 is a sensor that outputs the measurement result of the ambient temperature. The temperature sensor element 110 is, for example, a thermistor, a thermocouple, a semiconductor temperature sensor, or the like. The temperature sensor element 110 is connected to a control device via wiring and transmits information indicating the measurement result to the control device.

[0029] Looking at the X direction in Fig. 4, the temperature sensor elements 110 are arranged at equal intervals in the X direction. A plurality of temperature sensor elements 110 arranged at equal intervals in the X direction constitutes a row sensor element group 110a. A plurality of row sensor element groups 110a are arranged in the Y direction. Fig. 4 shows three row sensor element groups 110a.

[0030] An area of ​​the sheet 101 in which a certain row sensor element group 110a is arranged is connected to an area of ​​the sheet 101 in which an adjacent row sensor element group 110a is arranged by a curved or bent arm portion 102. In this embodiment, the arm portion 102 is a part of the sheet 101. In this embodiment, the arm portion 102 is formed by providing a cut 103 that penetrates the sheet 101 in a part of the sheet 101. The arm portion 102 is extendable in the Y direction, and the temperature sensor unit 100 transitions from the stored state of FIG. 4 to the deployed state of FIG. 5 when the arm portion 102 is pushed outward by the balloon 20 and extends.

[0031] Figure 5 shows a schematic diagram of the temperature sensor unit 100 in an unfolded state. The arm portions 102, which were curved or bent in the stored state of Figure 4, are extended in the unfolded state of Figure 5. As a result, the distance between adjacent temperature sensor elements 110 in the Y direction in the unfolded state of Figure 5 (D2, described below) is longer than the distance in the stored state of Figure 4. For example, in applications involving use in the human esophagus, the height (dimension in the X direction) of the tubular sheet 101 in the unfolded state is 1 cm to 10 cm, for example 6 cm, and the diameter of the sheet 101 is 1 cm to 5 cm, for example 2 cm.

[0032] Looking at the Y direction in Figure 5, the temperature sensor elements 110 are arranged at equal intervals in the Y direction in the unfolded state. The plurality of temperature sensor elements 110 arranged at equal intervals in the Y direction constitutes a row sensor element group 110b. A plurality of row sensor element groups 110b are arranged in the X direction. Figure 5 shows three row sensor element groups 110b.

[0033] 5, the distance (first distance) between adjacent temperature sensor elements 110 in the X direction is D1, and the distance (second distance) between adjacent temperature sensor elements 110 in the Y direction is D2. That is, in the unfolded state, the row sensor element groups 110a are arranged at first distances D1 in the X direction, and the column sensor element groups 110b are arranged at second distances D2 in the Y direction.

[0034] The first distance D1 and the second distance D2 are set depending on the application. In an application for monitoring the temperature inside the esophagus to prevent thermal damage during left atrial ablation, for example, the first distance D1 and the second distance D2 are set to 1 mm to 10 mm, for example 6 mm. This makes it possible to monitor the temperature inside the esophagus with a resolution of a predetermined interval. If the monitored temperature exceeds a predetermined value, the ablation can be stopped, for example, to prevent thermal damage to biological tissue.

[0035] In a living body, heat tends to diffuse in the direction of bodily fluid flow. Because blood vessels around the esophagus run along the esophagus, heat applied to tissues around the esophagus, such as the heart, tends to diffuse in the direction of the esophagus's length. Therefore, unless temperature monitoring is performed at short intervals and with high density (high resolution) in the direction of the esophagus's length, it is not possible to accurately detect high-temperature locations due to thermal diffusion. Therefore, in this embodiment, the first distance D1 in the X direction, which coincides with the direction of the esophagus's length during use, may be configured to be shorter than the second distance D2. For example, the first distance D1 may be equal to or greater than 1 mm and less than 6 mm, and the second distance D2 may be 6 mm.

[0036] With this configuration, the temperature sensor elements 110 are arranged in the X direction, which coincides with the extension direction of the esophagus during use, at a density high enough to accurately detect the position of the high-temperature inner surface of the esophagus. In this way, the temperature sensor unit 100 can accurately detect the increase in tissue temperature due to ablation based on anatomical knowledge, without causing tissue damage due to heat.

[0037] 6 is a schematic cross-sectional view of the temperature sensor unit 100 of FIG. 4 taken along line VI-VI. As described above, a plurality of temperature sensor elements 110 are arranged on a sheet 101. The temperature sensor unit 100 may include a protective layer 105 that covers the temperature sensor elements 110. This can absorb external shocks and prevent damage to the temperature sensor elements 110. The protective layer 105 also prevents the temperature sensor elements 110 and wiring, etc., from coming into contact with moisture and deteriorating.

[0038] 6, the protective layer 105 is provided so as to cover the entire surface of the plurality of temperature sensor elements 110 and the sheet 101, but this embodiment is not limited to this. For example, the protective layer 105 may be disposed only on one or more temperature sensor elements 110. Alternatively, the protective layer 105 may be disposed so as to cover the top and side surfaces of one or more temperature sensor elements 110.

[0039] The protective layer 105 may include, for example, polyimide, liquid crystal polymer, polyethylene terephthalate, silicone, polyurethane, polyether block amide, or a combination thereof.

[0040] The protective layer 105 may contain a metal such as Cu, Al, Ni, Ag, or Au. When the protective layer 105 contains a metal with high thermal conductivity, external heat, for example, heat from the inner surface of the esophagus, is quickly conducted to the temperature sensor element 110. Therefore, the temperature measuring device 1 can measure the external temperature with high accuracy.

[0041] The thickness t of the temperature sensor unit 100 is, for example, 1 mm or less. This thinness makes the temperature sensor unit 100 flexible and allows it to deform to fit the shape of the inner wall of the organ. Therefore, each of the multiple temperature sensor elements 110 can be in close contact with the inner wall of the organ, allowing the temperature inside the organ to be measured accurately. The thickness t of the temperature sensor unit 100 is not limited to this value and may be 0.5 mm or less, or 0.1 mm or less.

[0042] Furthermore, by configuring the temperature sensor unit 100 to be thin as described above, it is possible to reduce the heat capacity of the temperature sensor unit 100. Therefore, the thermal response of the temperature sensor unit 100 becomes faster, and the temperature inside the organ can be measured accurately.

[0043] The thickness t of the temperature sensor unit 100 is expressed, for example, as the sum of the thickness of the sheet 101 and the thickness of the protective layer 105. The protective layer 105 is not an essential component of the temperature sensor unit 100, and if the protective layer 105 is not present, the thickness t of the temperature sensor unit 100 may be expressed, for example, as the sum of the thickness of the sheet 101 and the thickness of the temperature sensor element 110.

[0044] The temperature sensor unit 100 may further include a metal layer made of a metal such as Cu, Al, Ni, Ag, or Au. Such a metal layer is disposed, for example, on the sheet 101 or between the sheet 101 and the protective layer 105, and is used for wiring for the temperature sensor element 110. Furthermore, the inclusion of the metal layer improves the strength of the temperature sensor unit 100 against impact, bending, and the like.

[0045] The temperature measuring device 1 as described above is used by a user such as a doctor, for example, in the following manner. (1) The user inserts the shaft 10 into the esophagus through the nose and / or mouth, thereby placing the temperature measuring device 1 (see Figures 1 and 2) including the temperature sensor unit 100 in a housed state and the balloon 20 in a deflated state in the esophagus. (2) The user pushes the guide member 30 in the distal direction while fixing the shaft 10, thereby moving the balloon 20 and the temperature sensor unit 100 out of the shaft 10 via the distal end 11 of the shaft 10. (3) The user uses a pump or the like to send gas into the balloon 20 to expand the balloon 20 (see FIG. 3). (4) Measurement results from the plurality of temperature sensor elements 110 of the temperature sensor unit 100 are obtained.

[0046] Alternatively to (2) above, the user may move the balloon 20 and the temperature sensor unit 100 outside the shaft 10 via the distal end 11 of the shaft 10 by pulling the shaft 10 while fixing the guide member 30.

[0047] As described above, the temperature measuring device 1 according to this embodiment includes the shaft 10, which is an example of a pipe, and the temperature sensor unit 100. The temperature sensor unit 100 includes a flexible sheet 101 and a plurality of temperature sensor elements 110 arranged on the sheet 101, and can be housed inside the shaft 10.

[0048] With this configuration, the sheet 101 is flexible, and the temperature sensor unit 100 can deform along the inner wall of the shaft 10. Therefore, gaps are less likely to occur inside the shaft 10, and the temperature sensor elements 110 can be arranged in the shaft 10 at high density.

[0049] Furthermore, because the sheet 101 of the temperature sensor unit 100 is flexible, it easily adheres to the inner wall of the organ, which contains water, due to surface tension. Therefore, the temperature inside the organ can be measured with higher accuracy than with conventional techniques.

[0050] The temperature sensor unit 100 may be capable of transitioning between a housed state in which it is housed within the shaft 10 and a deployed state in which it is deployed outside the shaft 10 .

[0051] According to this configuration, the temperature sensor units 100 densely housed inside the shaft 10 are deployed, making it possible to measure temperatures over a wide range.

[0052] The shaft 10 may have a distal end 11 and a proximal end 12. The temperature measuring device 1 may further include a guide member 30 that moves the temperature sensor unit 100 from inside the shaft 10 to outside the shaft 10 via the distal end 11. After the temperature sensor unit 100 is moved outside the shaft 10 via the distal end 11 by the guide member 30 in the housed state, the temperature sensor unit 100 may be capable of being expanded in a direction from the inside to the outside of the shaft 10 when the shaft 10 is viewed in cross section in a direction intersecting the direction from the distal end 11 to the proximal end 12, thereby transforming into an expanded state.

[0053] According to this configuration, the temperature sensor units 100 densely housed inside the shaft 10 are deployed, making it possible to measure the temperature inside a tubular organ in a living body over a wide range.

[0054] The temperature measuring device 1 may further include a balloon 20, which is an example of an expansion member. The balloon 20 is expandable in a direction from the inside to the outside of the shaft 10 when the shaft 10 is viewed in cross section from a direction intersecting the direction from the distal end 11 to the proximal end 12, and is pressurizable in a direction from the inside to the outside of the shaft 10 when the temperature sensor unit 100 is viewed in cross section.

[0055] According to this configuration, the temperature sensor units 100 housed in the shaft 10 at high density can be deployed.

[0056] At least a portion of the balloon 20 may be disposed radially inward of the temperature sensor unit 100 in the housed state.

[0057] This configuration makes it easier for the temperature sensor unit 100 to come into direct contact with the inner wall of the organ, allowing the temperature inside the organ to be measured with higher accuracy.

[0058] The temperature measuring device 1 may further include a protective layer 105 that covers the temperature sensor unit 100 .

[0059] According to this configuration, the protective layer 105 can absorb external impacts and prevent damage to the temperature sensor element 110. In addition, the protective layer 105 can prevent the temperature sensor unit 100 and components such as wiring from coming into contact with moisture and deteriorating.

[0060] The protective layer 105 may include a metal.

[0061] With this configuration, external heat, for example heat from the inner surface of the esophagus, is quickly conducted to the temperature sensor unit 100 via the metal-containing protective layer 105. Therefore, the temperature measuring device 1 can measure the external temperature with high accuracy.

[0062] The plurality of temperature sensor elements 110 are arranged so that the distance between adjacent temperature sensor elements 110 is equal to or less than a predetermined value.

[0063] With this configuration, the temperature inside the organ can be measured at multiple points.

[0064] The temperature sensor unit 100 may have four or more temperature sensor elements 110. In this case, the four or more temperature sensor elements 110 have a row sensor element group 110a and a column sensor element group 110b, which are temperature sensor elements 110 arranged in a row direction and a column direction that intersect with each other on the temperature sensor unit 100 in the unfolded state. The row sensor element group 110a is arranged at a first distance D1 in the axial direction of the shaft 10 in the unfolded state. The column sensor element group 110b is arranged at a second distance D2 in a direction that intersects with the axial direction of the shaft 10 in the unfolded state. The first distance D1 is shorter than the second distance D2.

[0065] With this configuration, the temperature sensor elements 110 are arranged at a higher density in the row direction, which coincides with the extension direction of the tubular organ during use, compared to the column direction. Therefore, the temperature measuring device 1 can measure the temperature in the row direction with high accuracy.

[0066] (Second embodiment) 7 and 8 are schematic diagrams showing an example configuration of the temperature sensor unit 200 in the temperature measuring device 2 according to the second embodiment of the present disclosure. Fig. 7 is a plan view showing the temperature sensor unit 200 in the housed state as viewed from the distal side of the axis C (the right side as one faces the paper surface of Fig. 1). In Fig. 7, the distal end 11 of the shaft 10 is hatched with dots to clearly distinguish the components.

[0067] 7, in the housed state, the flexible sheet-like temperature sensor unit 200 is wrapped around the balloon 20. This reduces the radial dimension of the temperature sensor unit 200, allowing the temperature sensor unit 200 to be housed within the shaft 10.

[0068] As in the first embodiment, the balloon 20 is pushed out distally from the shaft 10 and then expands, thereby pushing outward the temperature sensor unit 200. This causes the temperature sensor unit 200 to transition from the housed state shown in FIG. 7 to the deployed state shown in FIG. 8.

[0069] Figure 8 is a plan view schematically showing the temperature sensor unit 200 in the deployed state, as seen from the distal side of the axis C. The temperature sensor unit 200, which is wound around the balloon 20, is pushed outward by the balloon 20 while the number of turns decreases as the balloon 20 expands. In the deployed state of Figure 8, the radial dimension of the temperature sensor unit 200 is larger than in the housed state shown in Figure 7. With this configuration, the temperature sensor unit 200 in the deployed state can come into contact with the inner wall of a tubular organ in a living body, such as the esophagus.

[0070] In this embodiment, the surface of the sheet of the temperature sensor unit 200 is hydrophilic. In particular, the surface of the sheet that faces the inner wall of a tubular organ in a living body into which the temperature sensor unit 100 is inserted when the temperature sensor unit 100 is in an expanded state is hydrophilic. For example, the surface of the sheet is hydrophilic by being made of a hydrophilic material. Alternatively, the surface of the sheet may be hydrophilic by being treated to be hydrophilic.

[0071] In this specification, "hydrophilic" refers to the property of a target surface (in this embodiment, the surface of a sheet) such that the contact angle θ with water is 0 degrees < θ ≦ 90 degrees when measured according to the methods shown in (1) to (3) below. (1) Place the temperature sensor unit 100 so that the target surface is facing up and horizontal. (2) Drops of water are placed on the target surface and allowed to stand for a predetermined period of time (e.g., 10 minutes). (3) The contact angle θ between the target surface and water is measured.

[0072] Since the surface of the sheet of the temperature sensor unit 200 is hydrophilic, the sheets can easily adhere to each other when the temperature sensor unit 200 is stored, and the temperature sensor units 200 can be stored in the shaft 10 at high density.

[0073] (Third embodiment) 9A, 9B, 10A, and 10B are schematic diagrams showing a configuration example of the temperature sensor unit 300 in the temperature measuring device 3 according to the third embodiment of the present disclosure. Fig. 9A is a plan view showing a schematic view of the temperature sensor unit 300 in the housed state as seen from the distal side of the axis C.

[0074] 9A, in the stored state, the flexible sheet-like temperature sensor unit 300 has multiple folds extending in the axial direction, and is folded by being bent along these folds. This reduces the radial dimension of the temperature sensor unit 300, allowing the temperature sensor unit 300 to be stored inside the shaft 10.

[0075] 9B is a perspective view schematically showing the temperature sensor unit 300 in the accommodated state. The fold of the temperature sensor unit 300 is provided, for example, at the position indicated by the dashed line in FIG. 9B. The temperature sensor element 110 is arranged so as not to straddle the fold.

[0076] As in the first and second embodiments, the balloon 20 is pushed distally from the shaft 10 and then expands, thereby outwardly spreading the temperature sensor unit 300. This causes the temperature sensor unit 300 to transition from the housed state shown in Fig. 9A to the deployed state shown in Fig. 10A.

[0077] Fig. 10A is a plan view schematically showing the temperature sensor unit 300 in the deployed state as viewed from the distal side of the axis C. The folded temperature sensor unit 300 is pushed outward by the expanding balloon 20. As a result, in the deployed state of Fig. 10A, the radial dimension of the temperature sensor unit 300 is larger than in the stored state shown in Fig. 9A.

[0078] 10B is a perspective view schematically showing the temperature sensor unit 300 in the unfolded state. The folds of the temperature sensor unit 300 are straightened in the unfolded state. In this way, the temperature sensor unit 300 transitions to the unfolded state by the folds being straightened.

[0079] Fig. 11 is a schematic diagram showing a modified example of the temperature sensor unit 301 in this embodiment. Fig. 11 is a plan view showing the temperature sensor unit 301 in the housed state as seen from the distal side of the axis C. As shown in Fig. 11, in the housed state, a portion of the temperature sensor unit 301 may be in contact with the inner wall of the shaft 10 and bent along the inner wall of the shaft 10. This allows the shortest distance between the axis C and the temperature sensor unit 301 in the deployed state to be greater than the shortest distance D3 between the axis C and the temperature sensor unit 301 shown in Fig. 10.

[0080] (Fourth embodiment) 12 and 13 are cross-sectional views schematically showing an example of the configuration of a temperature measuring device 4 according to a fourth embodiment of the present disclosure. In the first embodiment, the temperature sensor unit 200 is disposed outside the balloon 20 (see, for example, FIGS. 2 and 3), whereas in this embodiment, at least a portion of the balloon 20 is disposed radially outward of the temperature sensor unit 400 in the accommodated state. In other words, the temperature sensor unit 400 of the temperature measuring device 4 is disposed inside the balloon 20.

[0081] Figure 12 schematically shows the temperature sensor unit 400 in a stored state. Figure 13 schematically shows the temperature sensor unit 400 in a deployed state. At least a portion of the temperature sensor unit 400 is physically connected to the inner surface of the balloon 20 by adhesive or other means. As a result, the balloon 20 is pushed out from the shaft 10 by the guide member 30 and changes from a contracted state to an expanded state, thereby pulling the temperature sensor unit 400 radially outward. The pulled temperature sensor unit can transition from a stored state to a deployed state.

[0082] 12 and 13, the multiple temperature sensor elements 110 are arranged on (inside) the inner surface of the sheet 401. However, this embodiment is not limited thereto, and the multiple temperature sensor elements 110 may be arranged on (outside) the outer surface of the sheet 401. That is, the multiple temperature sensor elements 110 may be arranged between the outer surface of the sheet 401 and the inner surface of the balloon 20. Furthermore, the multiple temperature sensor elements 110 may be arranged on both the outer and inner surfaces of the sheet 401.

[0083] As described above, in this embodiment, since the temperature sensor unit 400 is positioned inside the balloon 20, the temperature sensor unit 400 follows the movement of the balloon 20, and therefore the temperature sensor unit 400 can be removed safely and easily.

[0084] (Fifth embodiment) 14 and 15 are cross-sectional views schematically showing an example of the configuration of a temperature measuring device 5 according to a fifth embodiment of the present disclosure. Fig. 14 schematically shows a stored state of the temperature sensor unit 500 of the temperature measuring device 5. Fig. 15 schematically shows a deployed state of the temperature sensor unit 500.

[0085] Balloon 520 of temperature measuring device 5 according to this embodiment has folds 521 and 522 extending in the axial direction. As shown in Fig. 14, balloon 520 is folded at folds 521 and 522 in a deflated state and accommodated within shaft 10. In this specification, folds 521 may be referred to as mountain folds, and folds 522 may be referred to as valley folds. In the example shown in Fig. 14, there are ten folds 521 and ten folds 522, but the number of folds is not limited to this.

[0086] The sheet 501 of the temperature sensor unit 500 is provided on (inside) the inner surface of the balloon 520. A plurality of temperature sensor elements 110 are arranged on (inside) the inner surface of the sheet 501. At least a portion of the temperature sensor unit 500 is physically connected to the inner surface of the balloon 520 by means of adhesion or the like. This allows the temperature sensor unit 500 to transition from the stored state in FIG. 14 to the deployed state in FIG. 15 as the balloon 520 changes from the contracted state to the expanded state.

[0087] When balloon 520 is folded, sheet 501 provided on balloon 520 is also folded. Sheet 501 may have folds at positions corresponding to folds 521 and 522 of balloon 520, which is the underlying layer.

[0088] The temperature sensor unit 500 is in contact with the balloon 520 and is arranged so that the multiple temperature sensor elements 110 do not overlap the folds 521 and 522. For example, as shown in FIG. 14 , the temperature sensor elements 110 are arranged on a portion of the sheet 501 that will not bend even when the balloon 520 is folded. If the sheet 501 has folds, the temperature sensor elements 110 are arranged on the sheet 501 so as not to straddle the folds. For example, the temperature sensor elements 110 are arranged on a portion of the sheet 501 that does not have folds.

[0089] By arranging the temperature sensor element 110 on the unfoldable portion of the sheet 501, the temperature sensor unit 500 can be folded compactly, allowing more temperature sensor elements 110 to be housed in the shaft 10. In addition, it is possible to prevent forces such as bending stress from being applied to the temperature sensor element 110.

[0090] (Modification of the fifth embodiment) 16 to 18 are cross-sectional views schematically showing configuration examples of a temperature measuring device 5 according to a modification of the fifth embodiment. Fig. 16 is a plan view schematically showing a balloon 520 in a deflated state as viewed from the distal side of the axis C. As shown in Fig. 16, in the deflated state, the balloon 520 is folded at the crease and accommodated within the shaft 10.

[0091] In the example shown in Fig. 16, the balloon 520 has a first portion 520a, a second portion 520b, and a third portion 520c. In Figs. 16 to 18, the first portion 520a, the second portion 520b, and the third portion 520c are hatched differently from one another to facilitate understanding. The first portion 520a, the second portion 520b, and the third portion 520c are connected to one another. Furthermore, the first portion 520a, the second portion 520b, and the third portion 520c each have folds extending in the axial direction and are folded along the folds. This allows the balloon 520 to be housed within the shaft 10.

[0092] A plurality of temperature sensor elements 110 are disposed on the unfolded portions of the first portion 520a, the second portion 520b, and the third portion 520c of the balloon 520.

[0093] As shown in Fig. 17, when the balloon 520 moves out of the shaft 10, the folds of the first portion 520a, the second portion 520b, and the third portion 520c straighten, and the balloon 520 expands in the radial direction. When gas is injected into the balloon 520 in the intermediate state shown in Fig. 17, the balloon 520 expands and can transition to the expanded state shown in Fig. 18. In the expanded state, the multiple temperature sensor elements 110 are arranged, for example, at equal intervals in the circumferential direction.

[0094] (Sixth embodiment) A temperature measuring device according to a sixth embodiment of the present disclosure will be described below with reference to Figures 19 to 22. The main difference between the first embodiment and this embodiment is that the temperature measuring device 1 according to the first embodiment includes a balloon 20 as an expansion member, whereas the temperature measuring device according to this embodiment includes a basket catheter 620 as an expansion member.

[0095] 19 and 20 are side views schematically showing an example of the configuration of a basket catheter 620 of a temperature measuring device according to this embodiment. Figures 19 and 20 show the basket catheter 620 in a contracted state and an expanded state, respectively.

[0096] The basket catheter 620 has a cylindrical guide member 630 and a plurality of wires 621 that extend in the axial direction and can be housed within the guide member 630. The distal ends of the plurality of wires 621 are bound together, for example, by a bundling portion 622. Alternatively, the distal ends of the plurality of wires 621 may be bound together by means of adhesion, fusion, or the like.

[0097] 20 , each wire 621 can be curved and expanded radially to form a cage-shaped basket portion 623 that surrounds a space 624. This causes the basket catheter 620 to transition to an expanded state. The basket catheter 620 is not limited to the above example, and any known basket catheter configuration may be employed.

[0098] 21 and 22 are cross-sectional views schematically showing an example of the configuration of the temperature measuring device 6 according to this embodiment. Fig. 21 schematically shows the stored state of the temperature sensor unit 600 of the temperature measuring device 6. Fig. 22 schematically shows the deployed state of the temperature sensor unit 600.

[0099] 21 and 22, a sheet 601 of the temperature sensor unit 600 has folds 602 and 603 extending in the axial direction. As shown in Fig. 21, in the contracted state, the sheet 601 is folded at the folds 602 and 603 and accommodated in the shaft 10.

[0100] The multiple temperature sensor elements 110 are arranged on the sheet 601 so as not to straddle the folds 602, 603. In the example shown in Figures 21 and 22, the multiple temperature sensor elements 110 are arranged on a portion of the inner surface of the sheet 601 that does not have the folds 602, 603. However, this embodiment is not limited to this, and the multiple temperature sensor elements 110 may be arranged on the outer surface of the sheet 601, or on both the inner surface and the outer surface.

[0101] When the basket catheter 620 in the contracted state shown in Fig. 21 moves to the outside of the shaft 10 and then transitions to the expanded state, the sheet 601 of the temperature sensor unit 600 is pushed open by the multiple wires 621 of the basket catheter 620. This causes the temperature sensor unit 600 to transition from the housed state shown in Fig. 21 to the expanded state shown in Fig. 22.

[0102] (Seventh embodiment) A temperature measuring device according to a seventh embodiment of the present disclosure will be described below with reference to FIGS.

[0103] FIG. 23 is a schematic diagram showing an example of the configuration of a temperature sensor unit 700 and a balloon 720 of a temperature measuring device according to this embodiment. For ease of explanation, FIG. 23 shows an X-axis, a Y-axis, and a Z-axis that are orthogonal to one another. The direction of the X-axis is parallel to the extension direction of the shaft 10 (for example, the direction of axis C in FIG. 1). Here, the "extension direction of the shaft 10" refers to, for example, the direction in which the shaft 10 extends when the shaft 10 is extended linearly. In addition, in FIG. 23, the balloon 720 is hatched with dots to facilitate understanding of the configuration example. The dotted hatching in FIG. 23 is not intended to show a cross section of the balloon 720.

[0104] At least a portion of the temperature sensor unit 700 contacts the front or rear surface of the balloon 720. At least a portion of the temperature sensor unit 700 may be physically connected to the front or rear surface of the balloon 720 by means such as adhesion.

[0105] 14 or 16, the balloon 720 and the temperature sensor unit 700 are folded along folds extending in the X direction and stored in the shaft 10. In this way, the balloon 720 and the temperature sensor unit 700 can be folded so as to reduce the dimension in the Y direction when transitioning from the deployed state to the stored state.

[0106] The temperature sensor unit 700 includes a sheet 701 and a plurality of temperature sensor elements 110 arranged on the sheet 701. In the example shown in FIG. 23 , the sheet 701 includes a plurality of first portions 701a extending in the X direction and second portions 701b connecting adjacent first portions 701a in the Y direction. The sheet 701 further includes a third portion 701c extending from the first portions 701a on the opposite side of the first portions 701a from the second portions 701b in the Y direction. The third portion 701c connects adjacent first portions 701a in the Y direction.

[0107] 23, sheet 701 has a plurality of openings 702a surrounded by first portion 701a and second portion 701b, and a plurality of openings 702b surrounded by first portion 701a and third portion 701c. Thus, sheet 701 has a lattice shape formed by a plurality of linear portions 701a, 701b, and 701c extending in different directions.

[0108] For example, the first portion 701a, the second portion 701b, and the third portion 701c of the sheet 701 are provided with wiring that connects the plurality of sensor elements 110 to one another.

[0109] In this specification, the direction in which the second portion 701b or the third portion 701c of the sheet 701 extends may be referred to as the "first direction." If the first direction is the direction in which the second portion 701b of the sheet 701 extends, the direction in which the third portion 701c extends may be referred to as the "third direction." Alternatively, if the first direction is the direction in which the third portion 701c of the sheet 701 extends, the direction in which the second portion 701b extends may be referred to as the "third direction."

[0110] The first direction is configured so as not to be parallel to the Y direction (sometimes referred to herein as the "third direction" or "folding direction") and not to be perpendicular to the Y direction. In the example shown in FIG. 23, the angle φ2 that the second portion 701b makes with respect to the +X direction satisfies the relationship 0°<φ2<90° or 180°<φ2<270°. In the example shown in FIG. 23, the angle φ3 that the third portion 701c makes with respect to the +X direction satisfies the relationship 90°<φ3<180° or 270°<φ3<360°.

[0111] As described above, the first direction is configured so as not to be parallel to or perpendicular to the third direction (Y direction). In the example shown in Fig. 23, the X direction is perpendicular to the Y direction, so the first direction is neither parallel to nor perpendicular to the third direction (Y direction) nor to the extension direction (X direction) of the shaft 10.

[0112] The length (depth) y1 [mm] of the sensor element 110 in the Y direction satisfies, for example, 0.05≦y1≦3. The distance y2 [mm] between adjacent first portions 701a in the Y direction (the depth of the openings 702a or 702b) satisfies, for example, 1≦y2≦20. The depth y3 [mm] of the first portions 701a of the sheet 701 satisfies, for example, 0.05≦y1≦3. Although FIG. 23 shows an example in which y1 is smaller than y3, y1=y3 may also be the case.

[0113] The depth values ​​y1 to y3 are representative values ​​and may vary within ±Δy due to expansion or contraction, etc. Here, Δy is, for example, a value greater than 0% and less than 100% of the representative value. For example, Δy is 10% of the representative value.

[0114] In this embodiment, the first direction in which the sheet 701 extends is configured so as not to be parallel or perpendicular to the third direction (Y direction). This makes it possible to prevent or reduce the degree of swelling when the temperature sensor unit 700 is wound or folded around the X axis to store it in a storage state. This effect will be described below with reference to Figures 24 to 27 showing an example of this embodiment and Figures 28 to 30 showing a comparative example.

[0115] Fig. 24 is a cross-sectional view of the temperature sensor unit 700 and the balloon 720 taken along line XXIV-XXIV in Fig. 23. Fig. 25 is a schematic diagram showing a cross section of the temperature sensor unit 700 and the balloon 720 in the housed state, corresponding to Fig. 24.

[0116] 23, when y1=1, y2=5, and y3=1, the sensor element 110 and the sheet 701 can be configured not to be aligned in a line in the radial direction in the housed state, as shown in Fig. 25. This allows the radial dimensions of the temperature sensor unit 700 and the balloon 720 in the housed state to be reduced.

[0117] For example, when the length (thickness) of the sensor element 110 in the Z direction is 80 μm, the thickness of the sheet 701 is 40 μm, and the thickness of the balloon 720 is 50 μm, the temperature sensor unit 700 and the balloon 720 can be housed in a shaft 10 with an inner diameter of 2.706 mm. This is smaller than the dimensions of the temperature sensor unit and balloon in the housed state in a comparative example described below (see FIG. 30). Note that the shaft 10 can be deformed by external pressure. The inner diameter of the shaft 10 described above represents the diameter of the circular cross section of the shaft 10 before deformation occurs.

[0118] Fig. 26 is a cross-sectional view of the temperature sensor unit 700 and the balloon 720 taken along line XXVI-XXVI in Fig. 23. Fig. 27 is a schematic diagram showing a cross section of the temperature sensor unit 700 and the balloon 720 in the housed state, corresponding to Fig. 26.

[0119] 26 and 27, in the cross section taken along line XXVI-XXVI in Fig. 23, there is a portion where the sheet 701 is absent on the balloon 720. This reduces the degree of swelling or bulging of the temperature sensor unit 700.

[0120] 23, when y1=1, y2=5, and y3=1, the thickness of the sheet 701 is 40 μm, and the thickness of the balloon 720 is 50 μm, the temperature sensor unit 700 and the balloon 720 can be housed in a shaft 10 having an inner diameter of 2.652 mm. This is smaller than the dimensions of the temperature sensor unit and balloon in the housed state in a comparative example described later (see FIG. 30).

[0121] 28 is a schematic diagram showing an example of the configuration of a temperature sensor unit 800 and a balloon 720 according to a comparative example of this embodiment. Similar to the temperature sensor unit 700 of FIG. 23, the temperature sensor unit 800 includes a sheet 801 and a plurality of temperature sensor elements 110 arranged on the sheet 801. The sheet 801 has a plurality of first portions 801a extending in the X direction and a plurality of second portions 801b extending in the Y direction and intersecting with the first portions 801a.

[0122] The second portion 801b of the sheet 801 differs from the second portion 701b of the sheet 701 shown in FIG. 23 in that it extends parallel to the Y direction.

[0123] Fig. 29 is a cross-sectional view of the temperature sensor unit 800 and the balloon 720 taken along line XXIX-XXIX in Fig. 28. Fig. 30 is a schematic diagram showing a cross section corresponding to Fig. 29 of the temperature sensor unit 800 and the balloon 720 in the housed state.

[0124] 26 and 27, in the modified example shown in Figures 29 and 30, in the cross section taken along line XXIX-XXIX in Figure 28, a sheet 801 is disposed over the entire surface of the balloon 720. As a result, when the temperature sensor unit 800 is wound or folded around the X-axis as the winding axis to put it into a housed state, a large swelling occurs compared to the temperature sensor unit 700 according to this embodiment.

[0125] For example, when y1 = 1, y2 = 5, and y3 = 1, the thickness of the sheet 801 is 40 μm, and the thickness of the balloon 720 is 50 μm, the shaft 10 must have an inner diameter of approximately 3.490 μm or more in order to accommodate the temperature sensor unit 800 and the balloon 720.

[0126] If the sheet 801 extends uninterrupted along the folding direction in this way, the sheet 801 will bulge out significantly when stored, making it impossible to arrange the temperature sensor elements 110 in the shaft 10 at high density.

[0127] In contrast, the temperature sensor unit 700 according to this embodiment is configured so that the first direction in which the sheet 701 extends is neither parallel nor perpendicular to the third direction (Y direction). This prevents or reduces the degree of swelling when the temperature sensor unit 700 is wound or folded around the X axis to store it in a storage state. This makes it possible to arrange the temperature sensor elements 110 in the shaft 10 at high density.

[0128] The temperature sensor unit 700 according to this embodiment is folded in the third direction (Y direction) so that the first direction in which the sheet 701 extends is neither parallel to nor perpendicular to the third direction (Y direction). In this way, this embodiment discloses a folding method for a temperature measuring device in which the temperature sensor unit 700 is folded in the third direction (Y direction) so that the first direction in which the sheet 701 extends is neither parallel to nor perpendicular to the third direction (Y direction).

[0129] In this embodiment, the balloon 720 and the temperature sensor unit 700 are configured to be foldable, but this embodiment is not limited to this. For example, a temperature sensor unit according to another example of this embodiment may be wrapped around a balloon and housed in the shaft 10 as shown in FIG. 7. Even when housed in this manner, the first direction in which the sheet 701 extends is neither parallel to nor perpendicular to the third direction (Y direction), thereby reducing overlap of the sheet 701 when wound around the X axis as the winding axis. This reduces the occurrence or degree of swelling during winding, and enables the temperature sensor elements 110 to be arranged densely within the shaft 10.

[0130] (Variation) Although the embodiments of the present disclosure have been described in detail above, the above description is merely an example of the present disclosure in every respect. Various improvements and modifications can be made without departing from the scope of the present disclosure. For example, the following modifications are possible. Note that, in the following, the same reference numerals are used for components similar to those in the above embodiment, and descriptions of the same points as those in the above embodiment will be omitted as appropriate. The following modifications can be combined as appropriate.

[0131] (First Modification) In the above embodiment, the esophagus has been described as an example of a tubular organ into which the shaft 10 is inserted, but the present disclosure is not limited thereto. For example, the tubular organ may be a cavity, a hollow organ, or the like in a living body. Specifically, the tubular organ into which the shaft 10 is inserted may be the trachea, lungs, oral cavity, stomach, intestines, external auditory canal, Eustachian tube, blood vessels, urinary tract, lymphatic vessels, or the like. The tubular organ is not limited to a human organ, but may be an organ of another living organism.

[0132] (Second Modification) In the first embodiment, the sheet 101 that can be expanded by providing the slits 103 has been described (see FIG. 4). However, the sheet 101 is not limited to this, and may be any sheet that can be expanded in the radial direction. For example, the sheet 101 may be a stent. Alternatively, the sheet 101 may have a structure similar to that of a stent. Furthermore, the sheet 101 may be provided with a slit that has a width when stored, rather than a narrow slit as illustrated in FIG. 4.

[0133] (Third Modification) In the second embodiment, an example has been described in which the surface of the sheet of the temperature sensor unit 200 is hydrophilic, but the present disclosure is not limited to this. For example, the surface of the sheet of the temperature sensor unit may be water-repellent. For example, the surface of the sheet has water-repellent properties by being made of a water-repellent material. Alternatively, the surface of the sheet may have water-repellent properties by being treated to be water-repellent.

[0134] In this specification, "water repellency" refers to the property of a target surface such that, when the contact angle θ with water on the target surface is measured according to the methods (1) to (3) above, the contact angle θ is 90 degrees < θ < 180 degrees.

[0135] Because the surface of the temperature sensor unit sheet is water-repellent, even when the temperature sensor unit is housed and densely packed inside the catheter, the sheets are likely to break contact when pushed outward by the expansion member.

[0136] Alternatively, the surface of the sheet of the temperature sensor unit may include a hydrophilic portion that is hydrophilic and a water-repellent portion that is water-repellent. FIG. 31 is a schematic diagram showing a configuration example of a temperature sensor unit 200 in a modified example of such an embodiment. FIG. 31 also shows an enlarged partial view of the area surrounded by the dashed line. The sheet 201 of the temperature sensor unit 200 includes a hydrophilic portion 201a and a water-repellent portion 201b. The hydrophilic portion 201a is arranged around each temperature sensor element 110 in a plan view. The water-repellent portion 201b is arranged around each hydrophilic portion 201a in a plan view.

[0137] The deployment units, such as the balloons described in the above embodiments, may be contracted after deployment. Contracting the deployment unit prevents the esophagus from expanding in the width direction. Contracting the deployment unit also prevents the deployment unit from pressing the inner wall of the esophagus against the heart, particularly the left atrium. As a result, excessive heat transfer from the heart to the esophagus can be prevented when performing cardiac ablation.

[0138] (Fourth Modification) In the above embodiment, a temperature measuring device inserted into the esophagus to monitor the temperature inside the esophagus during left atrial ablation has been described as an example. However, the use of the temperature measuring device according to the present disclosure is not limited to this, and the device may be applied to a treatment device used for treatment such as left atrial ablation. Furthermore, when performing treatment such as left atrial ablation, the temperature measuring device according to the present disclosure may be applied to both the treatment device and a device for monitoring the temperature inside the esophagus.

[0139] The above-mentioned treatment devices include, for example, a cryoballoon inserted into the left atrium to perform cryoablation on myocardial tissue such as the pulmonary vein, and a hot balloon to cauterize myocardial tissue. In cryoballoon treatment, for example, a cooling gas is used to cool the balloon to about -60°C, causing cryonecrosis of the myocardial tissue around the balloon. In hot balloon treatment, for example, high frequency waves are applied to electrodes inside the balloon to heat a liquid injected into the balloon, causing ablation of the myocardial tissue around the balloon.

[0140] FIG. 32 is a cross-sectional view schematically showing an example of the configuration of a temperature measuring device 8 according to this modification. The temperature measuring device 8 is provided in a treatment device. A balloon 820 is carried into the left atrium while housed in a shaft 810, and then protrudes from the shaft 810 and assumes the expanded state shown in FIG. 32. The inside of the balloon 820 is filled with gas or liquid. When used as a cryoballoon, the gas inside the balloon 820 is cooled to approximately -60°C. When used as a hot balloon, the liquid inside the balloon 820 is heated to approximately 60 to 70°C.

[0141] In conventional cryoballoons and hot balloons, temperature sensors are not located in the balloon portion that comes into contact with myocardial tissue, such as the pulmonary vein, but are located on the shaft inside the balloon. In contrast, in this modified example, multiple temperature sensor elements 110 are located on the outer surface of the balloon 820. This allows the temperature sensor elements 110 to come into contact with tissue, such as the inner surface of the pulmonary vein, during treatment and directly measure the temperature of the tissue. Therefore, the temperature measuring device 8 can measure the temperature of the tissue more accurately than when the temperature of the tissue is measured indirectly by measuring the temperature of the gas or liquid inside the balloon 820.

[0142] A heat insulating material may be provided between the gas or liquid inside the balloon 820 and each temperature sensor element 110. For example, a heat insulating material is provided on the inner and / or outer surface of the balloon 820, and the heat insulating material prevents the temperature of the gas or liquid inside the balloon 820 from being transmitted to each temperature sensor element 110. This reduces the degree of influence of the temperature of the gas or liquid inside the balloon 820 on the temperature measurement of myocardial tissue such as a pulmonary vein by each temperature sensor element 110. This allows the temperature of the tissue to be measured more accurately.

[0143] Aspects of the present disclosure The following additionally describes aspects of the present disclosure.

[0144] <1> Tube and a temperature sensor unit for measuring a temperature, the temperature sensor unit includes a flexible sheet and a plurality of temperature sensor elements disposed on the sheet, and is housed within the tube; Temperature measuring device.

[0145] <2> the temperature sensor unit is capable of transitioning between a storage state in which it is stored in the tube and a deployment state in which it is deployed outside the tube. <1> The temperature measuring device according to claim 1.

[0146] <3> the tube having a distal end and a proximal end; the temperature measuring device further comprises a guide member that moves the temperature sensor unit from inside the tube through the distal end to outside the tube; the temperature sensor unit is moved to the outside of the tube via the distal end by the guide member in the housed state, and then deployed in a direction from the inside to the outside of the tube when the tube is viewed in cross section from a direction intersecting the direction from the distal end to the proximal end, thereby transitioning to the deployed state. <2> The temperature measuring device according to claim 1.

[0147] <4> further comprising an expansion member receivable within the tube; the expansion member is expandable in a direction from the inside to the outside of the pipe when viewed in cross section from a direction intersecting a direction from one end to the other end of the pipe, and the temperature sensor unit is pressurizable in a direction from the inside to the outside of the pipe when viewed in cross section of the pipe. <1> The temperature measuring device according to claim 1.

[0148] <5> The temperature sensor unit is disposed around at least a portion of the expansion member. <4> The temperature measuring device according to claim 1.

[0149] <6> At least a portion of the extension member is disposed around the temperature sensor unit. <4> The temperature measuring device according to claim 1.

[0150] <7> the sheet has a first fold; the plurality of temperature sensor elements are arranged on the sheet so as not to straddle the first fold. <6> The temperature measuring device according to claim 1.

[0151] <8> The expansion member is a balloon. <4> ~ <7> 10. The temperature measuring device according to claim 9, wherein

[0152] <9> the balloon has a second fold and is capable of being accommodated in the tube by being folded at the second fold; the temperature sensor unit is in contact with the balloon and is arranged so that the plurality of temperature sensor elements do not overlap with the second fold. <8> The temperature measuring device according to claim 1.

[0153] <10> the expansion member includes a plurality of wires each extending in a direction from one end of the tube to the other end and bendable in a direction from the inside to the outside of the tube when viewed in cross section from a direction intersecting the direction from one end of the tube to the other end, <4> ~ <7> 10. The temperature measuring device according to claim 9, wherein

[0154] <11> the surface of the temperature sensor unit is hydrophilic; <1> ~ <10> 10. The temperature measuring device according to claim 9, wherein

[0155] <12> The surface of the temperature sensor unit is water-repellent. <1> ~ <10> 10. The temperature measuring device according to claim 9, wherein

[0156] <13> The surface of the temperature sensor unit includes a hydrophilic portion that is hydrophilic and a water-repellent portion that is water-repellent. <1> ~ <10> 10. The temperature measuring device according to claim 9, wherein

[0157] <14> the hydrophilic portion is disposed around each temperature sensor element; The water-repellent portion is disposed around the hydrophilic portion. <13> The temperature measuring device according to claim 1.

[0158] <15> the temperature sensor unit has a temperature sensor element including a thermistor, a thermocouple, a semiconductor temperature sensor, or a combination thereof; <1> ~ <14> 10. The temperature measuring device according to claim 9, wherein

[0159] <16> Further comprising a protective layer covering the temperature sensor unit. <1> ~ <15> 10. The temperature measuring device according to claim 9, wherein

[0160] <17> the protective layer comprises a metal; <16> The temperature measuring device according to claim 1.

[0161] <18> the temperature sensor unit is capable of transitioning to a deployed state in which it is deployed outside the tube; the plurality of temperature sensor elements are arranged such that, in the deployed state, a distance between adjacent temperature sensor elements among the plurality of temperature sensor elements is equal to or less than a predetermined value. <1> ~ <17> 10. The temperature measuring device according to claim 9, wherein

[0162] <19> the temperature sensor unit has four or more temperature sensor elements; the temperature sensor unit is capable of transitioning to a deployed state in which it is deployed outside the tube; In the expanded state, the four or more temperature sensor elements include a row sensor element group and a column sensor element group, which are temperature sensor elements arranged in a row direction and a column direction that intersect with each other on the temperature sensor unit, the row sensor element groups are arranged at first distances in a direction from one end of the tube to the other end in the deployed state; the array sensor element group is arranged at second intervals in a direction intersecting a direction from the inside to the outside of the tube when viewed in cross section from a direction intersecting a direction from one end to the other end of the tube in the deployed state, The first distance is less than the second distance. <1> ~ <18> 10. The temperature measuring device according to claim 9, wherein

[0163] <20> The device further includes an expansion member that can be housed in the tube and can expand in a direction that intersects with the extension direction of the tube, which is a direction from one end of the tube to the other end, The sheet is disposed on the expansion member, At least a portion of the sheet has a linear sheet portion extending in a first direction, The first direction is not parallel to the extension direction of the tube and is not perpendicular to the extension direction of the tube. <1> ~ <19> 10. The temperature measuring device according to claim 9, wherein

[0164] <21> The sheet has a plurality of first portions in which the linear sheet extends substantially parallel to the extension direction of the pipe, and a second portion in which the linear sheet extends in the first direction and connects the plurality of first portions. <20> The temperature measuring device according to claim 1.

[0165] <22> The sheet further has a linear sheet portion extending in a second direction different from the first direction, The second direction is not parallel to the extension direction of the tube and is not perpendicular to the extension direction of the tube. <20> or <21> The temperature measuring device according to claim 1.

[0166] <23> <1> ~ <22> A treatment device comprising the temperature measuring device according to any one of the preceding claims. [Explanation of symbols]

[0167] 1~6, 8 Temperature measuring device 10,810 shaft 11 Distal end 12 Proximal end 20 Balloon 30 Guide member 31 Gas flow path 100, 200, 300, 301, 400, 500, 600, 700 Temperature sensor unit 101, 201, 401, 501, 701 seats 102 Arm section 105 Protective layer 110 Temperature sensor element 110a row sensor element group 110b column sensor element group 201a Hydrophilic part 201b Water-repellent part 520 Balloon 520a Part 1 520b Part 2 520c 3rd part 521, 522 folds 602, 603 folds 620 Basket catheter 621 Wire 622 Binding section 623 Basketball Club 624 Space 630 Guide member 720 Balloon

Claims

1. Tube and an expansion member that is deformable between a contracted state housed within the tube and an expanded state expanded from the contracted state; a temperature sensor unit for measuring a temperature when the expansion member is in an expanded state; the temperature sensor unit includes a flexible sheet and a plurality of temperature sensor elements disposed on the sheet, the temperature sensor unit being housed within the tube and disposed inside or outside the expansion member; the sheet has a first fold; the plurality of temperature sensor elements are arranged on the sheet so as not to straddle the first fold. Temperature measuring device.

2. The temperature measuring device according to claim 1 , wherein the temperature sensor unit is capable of transitioning between a housed state in which the temperature sensor unit is housed within the pipe and a deployed state in which the temperature sensor unit is deployed outside the pipe.

3. the tube having a distal end and a proximal end; the temperature measuring device further comprises a guide member that moves the temperature sensor unit from inside the tube through the distal end to outside the tube; the temperature sensor unit is moved to the outside of the tube via the distal end by the guide member in the housed state, and then deployed in a direction from the inside to the outside of the tube when the tube is viewed in cross section from a direction intersecting the direction from the distal end to the proximal end, thereby transitioning to the deployed state. The temperature measuring device according to claim 2 .

4. the expansion member is expandable in a direction from the inside to the outside of the pipe when viewed in cross section from a direction intersecting a direction from one end to the other end of the pipe, and the temperature sensor unit is pressurizable in a direction from the inside to the outside of the pipe when viewed in cross section of the pipe. The temperature measurement device according to claim 1 .

5. The temperature sensor unit is disposed around at least a portion of the expansion member.

5. The temperature measuring device according to claim 4.

6. At least a portion of the extension member is disposed around the temperature sensor unit.

5. The temperature measuring device according to claim 4.

7. The temperature measuring device according to any one of claims 1 to 6, wherein the expansion member is a balloon.

8. Tube and a balloon that is deformable between a deflated state housed within the tube and an expanded state expanded from the deflated state; a temperature sensor unit for measuring the temperature when the balloon is in an inflated state; the temperature sensor unit includes a flexible sheet and a plurality of temperature sensor elements disposed on the sheet, the temperature sensor unit being housed within the tube and disposed inside or outside the balloon; the balloon is expandable in a direction from the inside to the outside of the tube when viewed in cross section from a direction intersecting a direction from one end of the tube to the other end, and the temperature sensor unit is pressurizable in a direction from the inside to the outside of the tube when viewed in cross section. the balloon has a second fold and is capable of being accommodated in the tube by being folded at the second fold; the temperature sensor unit is in contact with the balloon and is arranged so that the plurality of temperature sensor elements do not overlap with the second fold. Temperature measuring device.

9. The temperature measuring device according to any one of claims 1 to 6, wherein the expansion member includes a plurality of wires each extending in a direction from one end of the tube to the other end and capable of being bent in a direction from the inside to the outside of the tube when viewed in cross section from a direction intersecting the direction from one end of the tube to the other end.

10. 7. The temperature measuring device according to claim 1, wherein the surface of the temperature sensor unit is hydrophilic.

11. 7. The temperature measuring device according to claim 1, wherein the surface of the temperature sensor unit is water-repellent.

12. 7. The temperature measuring device according to claim 1, wherein the surface of the temperature sensor unit includes a hydrophilic portion that is hydrophilic and a water-repellent portion that is water-repellent.

13. Tube and a temperature sensor unit that is capable of transitioning between a stored state in which the device is stored in the tube and a deployed state in which the device is deployed, and that measures a temperature in the deployed state; the temperature sensor unit includes a flexible sheet and a plurality of temperature sensor elements disposed on the sheet, and is housed within the pipe; the surface of the temperature sensor unit includes a hydrophilic portion that is hydrophilic and a water-repellent portion that is water-repellent; the hydrophilic portion is disposed around each temperature sensor element; The water-repellent portion is disposed around the hydrophilic portion. Temperature measuring device.

14. 7. The temperature measuring device according to claim 1, wherein the temperature sensor unit has a temperature sensor element including a thermistor, a thermocouple, a semiconductor temperature sensor, or a combination thereof.

15. 7. The temperature measuring device according to claim 1, further comprising a protective layer covering the temperature sensor unit.

16. The temperature measurement device of claim 15 , wherein the protective layer comprises a metal.

17. the temperature sensor unit is capable of transitioning to a deployed state in which it is deployed outside the tube; the plurality of temperature sensor elements are arranged such that, in the deployed state, a distance between adjacent temperature sensor elements among the plurality of temperature sensor elements is equal to or less than a predetermined value. The temperature measuring device according to any one of claims 1 to 6.

18. the temperature sensor unit has four or more temperature sensor elements; the temperature sensor unit is capable of transitioning to a deployed state in which it is deployed outside the tube; In the expanded state, the four or more temperature sensor elements include a row sensor element group and a column sensor element group, which are temperature sensor elements arranged in a row direction and a column direction that intersect with each other on the temperature sensor unit, the row sensor element groups are arranged at first distances in a direction from one end of the tube to the other end in the deployed state; the array sensor element group is arranged at second intervals in a direction intersecting a direction from the inside to the outside of the tube when viewed in cross section from a direction intersecting a direction from one end to the other end of the tube in the deployed state, the first distance is less than the second distance; The temperature measuring device according to any one of claims 1 to 6.

19. The device further includes an expansion member that can be housed in the tube and can expand in a direction that intersects with the extension direction of the tube, which is a direction from one end of the tube to the other end, The sheet is disposed on the expansion member, At least a portion of the sheet has a linear sheet portion extending in a first direction, The first direction is not parallel to the extension direction of the tube and is not perpendicular to the extension direction of the tube. The temperature measuring device according to any one of claims 1 to 3.

20. The sheet has a plurality of first portions in which the linear sheet extends substantially parallel to the extension direction of the pipe, and a second portion in which the linear sheet extends in the first direction and connects the plurality of first portions.

20. The temperature measurement device of claim 19.

21. The sheet further includes a linear sheet portion extending in a second direction different from the first direction, The second direction is not parallel to the extension direction of the tube and is not perpendicular to the extension direction of the tube.

20. The temperature measurement device of claim 19.

22. A treatment device comprising the temperature measuring device according to any one of claims 1 to 6.

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