WO2023149094A1

WO2023149094A1 - Temperature measurement device

Info

Publication number: WO2023149094A1
Application number: PCT/JP2022/045824
Authority: WO
Inventors: 雄希櫻田; 大典能登; 友貴大内; 功二田中
Original assignee: 株式会社村田製作所
Priority date: 2022-02-07
Filing date: 2022-12-13
Publication date: 2023-08-10

Abstract

A temperature measurement device according to the present invention comprises a tube, a temperature sensor unit, and a deployment unit. The temperature sensor unit can transition between an accommodation-possible state in which the temperature sensor unit can be accommodated within the tube, and a deployed state in which the temperature sensor unit is deployed out of the tube. The deployment unit transitions the temperature sensor unit from the accommodation-possible state to the deployed state. At least a portion of the temperature sensor unit is configured to be movable with respect to the deployment unit.

Description

temperature measuring device

The present disclosure relates to a temperature measurement device, and more particularly to a temperature measurement device that measures the temperature inside a tubular organ in vivo.

Left atrial ablation, which cauterizes the myocardium, is known as an example of atrial fibrillation treatment. Left atrial ablation can thermally damage the esophagus by transferring the cautery heat to the esophagus, which is anatomically close to the heart.

Therefore, a technique is known to prevent thermal damage to the esophagus by measuring the internal temperature of tubular organs in the body such as the esophagus. For example, U.S. Pat. No. 6,200,000 discloses a loop wire that is introduced into the subject's body. A loop wire carrying a temperature sensor is flexed outwardly, such as by a balloon, so that the temperature sensor is placed adjacent to or against an area of the surface of a tissue or organ within the subject's body. , the temperature of the surface can be detected.

Japanese translation of PCT publication No. 2011-517417

In the conventional technology, the temperature sensor may be damaged by being pressed against the inner wall of the esophagus by a balloon, loop wire, etc., and applying external force such as pressure and stress to the temperature sensor. A similar problem exists in a temperature measuring device that measures the temperature inside a tubular organ in a living body other than the esophagus.

An object of the present disclosure is to provide a temperature measuring device capable of suppressing the pressure applied to the temperature sensor compared to the conventional technology.

A temperature measurement device according to one aspect of the present disclosure includes a tube, a temperature sensor unit, and a deployment unit. The temperature sensor unit is transitionable between a stowable state in which it can be stowed within the tube and a deployed state in which it is deployed out of the tube. The deployment unit transitions the temperature sensor unit from the stowable state to the deployed state. At least part of the temperature sensor unit is configured to be movable with respect to the deployment unit.

According to the temperature measurement device according to the present disclosure, it is possible to suppress the pressure applied to the temperature sensor as compared with the conventional technology.

BRIEF DESCRIPTION OF THE DRAWINGS It is a perspective view which shows typically the structural example of the temperature measuring device which concerns on 1st Embodiment. FIG. 2 is a cross-sectional view of the temperature measurement device of FIG. 1 schematically illustrating a state in which a temperature sensor unit can be accommodated; FIG. 2 is a cross-sectional view of the temperature measurement device of FIG. 1, schematically illustrating an unfolded state of the temperature sensor unit; FIG. 4 is a schematic diagram showing a configuration example of a temperature sensor unit in a storable state; FIG. 4 is a schematic diagram showing a configuration example of the temperature sensor unit in an unfolded state; FIG. 5 is a schematic sectional view taken along the line VI-VI of the temperature sensor unit of FIG. 4; FIG. 11 is a schematic diagram showing a storable state of a temperature sensor unit in a temperature measuring device according to a second embodiment; FIG. 11 is a schematic diagram showing an unfolded state of the temperature sensor unit in the temperature measuring device according to the second embodiment; FIG. 11 is a schematic diagram showing a state in which a temperature sensor unit can be accommodated in a temperature measuring device according to a third embodiment; FIG. 11 is a schematic diagram showing an unfolded state of the temperature sensor unit in the temperature measuring device according to the third embodiment; FIG. 11 is a cross-sectional view schematically showing a state in which a temperature sensor unit of a temperature measuring device according to a fourth embodiment can be accommodated. FIG. 11 is a cross-sectional view schematically showing an unfolded state of a temperature sensor unit of a temperature measuring device according to a fourth embodiment; FIG. 11 is a schematic diagram showing a configuration example of a temperature sensor unit of a temperature measuring device according to a fifth embodiment; FIG. 11 is a schematic diagram showing a configuration example of a temperature sensor unit of a temperature measuring device according to a sixth embodiment; FIG. 21 is a side view schematically showing a balloon and a temperature sensor unit of a temperature measuring device according to a seventh embodiment; FIG. 21 is a side view schematically showing a contracted state of a basket catheter of a temperature measuring device according to an eighth embodiment; FIG. 21 is a side view schematically showing an expanded state of a basket catheter of a temperature measuring device according to an eighth embodiment; FIG. 21 is a cross-sectional view schematically showing a storable state of a temperature sensor unit of a temperature measuring device according to an eighth embodiment; FIG. 21 is a cross-sectional view schematically showing an unfolded state of a temperature sensor unit of a temperature measuring device according to an eighth embodiment; FIG. 5 is a cross-sectional view schematically showing a configuration example of a balloon in a modified example of the embodiment of the present disclosure;

An embodiment of a temperature measuring device according to the present disclosure will be described below with reference to the accompanying drawings. In addition, in the following embodiment, the same code|symbol is attached|subjected about the same or similar component. Also, in order to facilitate understanding of the description, the shape, size, positional relationship, etc. of each component may be exaggerated in the accompanying drawings. In addition, in the accompanying drawings, in order to facilitate understanding of the description, when showing cross-sectional views of each component, there are cases where illustration of parts other than cross-sections, hatching, etc. are omitted.

(First embodiment)
FIG. 1 is a perspective view schematically showing a configuration example of a temperature measurement device 1 according to the first embodiment of the present disclosure. The temperature measuring device 1 comprises a tubular shaft 10 , a temperature sensor unit 100 and a balloon 20 . The shaft 10 is an example of the "tube" of the present disclosure, and the balloon 20 is an example of the "deployment unit" of the present disclosure. FIG. 1 shows a virtual axis C indicating the axis of the shaft 10 for convenience of explanation.

In this specification, the direction parallel to the axis C is called the axial direction, and when a cylinder centered on the axis C is assumed, the direction perpendicular to the axis C is called the radial direction, and the circumferential direction of the cylinder is called the circumferential direction. . As for the axial direction, the rightward direction on the paper surface of FIG. 1 is positive. The positive axial direction is also referred to as the distal or distal direction, and the negative axial direction is also referred to as the proximal or proximal direction. Regarding the radial direction, the direction away from the axis C may be called outward, and the direction toward the axis C may be called inward.

The shaft 10 is, for example, a soft tube like the shaft of a catheter. Shaft 10 has a distal end (tip) 11 and a proximal end (proximal end) 12 . The shaft 10 is inserted into an in vivo tubular organ such as the esophagus. For example, the shaft 10 moves into the esophagus after being inserted into the mouth or nose from the distal end 11 side.

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

As used herein, "flexibility" means, for example, the property of bending due to an external force. Flexibility may include elasticity, stiffness. For example, low stiffness may be expressed as high flexibility. As used herein, "flexibility" includes flexibility. Flexibility may also include the property that an object can be freely deformed, in addition to flexibility.

In this embodiment, the temperature sensor unit 100 is arranged around at least part of the balloon 20 . In this case, the temperature sensor unit 100 may contact at least a portion of the balloon 20, but may not contact. For example, the temperature sensor unit 100 is arranged radially between the shaft 10 and the balloon 20 in the stowable state. The temperature sensor unit 100 is transitionable between a stowed state in which it is stowed within the shaft 10 and a deployed state in which it is deployed outside the shaft 10 to a diameter greater than the diameter of the shaft 10 . The storable state and the unfolded state of the temperature sensor unit 100 will be described below with reference to FIGS.

FIG. 2 is a cross-sectional view of the temperature measurement device 1, schematically illustrating a state in which the temperature sensor unit 100 can be accommodated. The cross section shown in FIG. 2 is a plane containing the axis C. As shown in FIG. A guide member 30 such as a wire is connected to the proximal end of the balloon 20 . The proximal end of guide member 30 extends outward through proximal end 12 of shaft 10 . Alternatively, the proximal end of guide member 30 may extend outward through an opening provided in the surface of shaft 10 . A user can axially move the balloon 20 connected to the guide member 30 by manipulating the outwardly extending guide member 30 by hand, drive device, or the like. Since the temperature sensor unit 100 is partially fixed to the balloon 20 by bonding or the like, the movement of the balloon 20 using the guide member 30 causes the temperature sensor unit 100 to move in the axial direction as the balloon 20 moves. be able to.

The movement of the guide member 30, the balloon 20, and the temperature sensor unit 100 as described above can be performed independently of the shaft 10. Therefore, the guide member 30 , the balloon 20 , and the temperature sensor unit 100 move axially relative to the shaft 10 and move further distally from the distal end 11 of the shaft 10 to exit the shaft 10 . be able to.

The balloon 20 can be reversibly deformed between a contracted state and an expanded state by taking gas in and out through the gas flow path 31 using a pump or the like. 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. FIG. Although an example in which the balloon 20 is deformed by gas in and out has been described, the present disclosure is not limited to this, and the balloon 20 may be deformed by liquid in and out.

The balloon 20 is deformable from the inside to the outside of the shaft 10 . For example, the balloon 20 is deformable in a direction from the inside to the outside of the shaft 10 when viewed cross-sectionally in a direction that intersects the direction from the proximal end 12 to the distal end 11 of the shaft 10 .

The balloon 20 expands radially outward after being pushed out from the shaft 10 by the guide member 30, thereby pushing the temperature sensor unit 100 apart. As a result, the temperature sensor unit 100 transitions from the stowable state shown in FIG. 2 to the unfolded state shown in FIG.

FIG. 3 is a cross-sectional view of the temperature measurement device 1, schematically exemplifying the deployed state of the temperature sensor unit 100. FIG. 2, the balloon 20 and the temperature sensor unit 100 are arranged outside the shaft 10 in FIG. 3, the balloon 20 is inflated and expanded, and the temperature sensor unit 100 is expanded by the balloon 20 and is in the expanded state. At least one radial dimension R of the temperature sensor unit 100 is greater than the inner diameter r of the shaft 10 in the deployed state.

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

At least part of the temperature sensor unit 100 is fixed to the deployment unit, while other parts of the temperature sensor unit 100 are not fixed to the balloon 20 . For example, only a portion of the temperature sensor unit 100 is connected to the proximal end 21 of the balloon 20 by a unit such as gluing. On the other hand, the temperature sensor unit 100 is not fixed to the balloon 20 at the contact portion 22 between the expanded balloon 20 and the temperature sensor unit 100 .

With this configuration, the temperature sensor unit 100 is movable with respect to the balloon 20 at the contact portion 22 . Assuming that the temperature sensor unit 100 is not movable with respect to the balloon 20, if the temperature sensor unit 100 is sandwiched between the expanded balloon 20 and the inner wall of the esophagus, the temperature sensor unit 100 is subjected to pressure, stress, or the like. is applied, the temperature sensor unit 100 may be damaged. On the other hand, since the temperature sensor unit 100 is movable with respect to the balloon 20, the temperature sensor unit 100 and the balloon 20 move relatively when the above external force is applied to the temperature sensor unit 100. By doing so, the external force can be released. As described above, according to the temperature measurement device 1 according to the present embodiment, it is possible to reduce the external force applied to the temperature sensor unit 100 and reduce the risk of damage to the temperature sensor.

The inner surface of the temperature sensor unit 100 and/or the outer surface of the balloon 20 is made of a material with low static friction so that the temperature sensor unit 100 slides easily against the balloon 20 at the contact portion 22. may be coated with For example, the inner surface of the temperature sensor unit 100 and/or the outer surface of the balloon 20 are made of or coated with one or more materials selected from the group consisting of hydrophilic resins, hydrophobic resins, and metals.

4 and 5 are schematic diagrams showing configuration examples of the temperature sensor unit 100. FIG. For convenience of explanation, FIGS. 4 and 5 show X, Y, and Z axes that are orthogonal to each other. In this specification, the X-axis direction is sometimes called the row direction, and the Y-axis direction is sometimes called the column direction. In this embodiment, the direction of the X-axis coincides with the direction of the axis C in FIG. 1, and the direction of the Z-axis coincides with the radial direction.

FIG. 4 schematically shows the temperature sensor unit 100 in a storable state. The temperature sensor unit 100 has a sheet 101 and a plurality of temperature sensor elements 110 arranged on the sheet 101 .

The sheet 101 is flexible and has a shape that spreads in the X and Y directions. In FIG. 4, the Y direction indicates the circumferential direction. Although omitted in FIG. 4, the sheet 101 further extends in the Y direction of FIG. 4 and has a tubular shape as a whole by connecting the upper end and the lower end of the sheet 101 in FIG. Sheet 101 comprises, for example, polyimide, liquid crystal polymer, polyethylene terephthalate, silicone, polyurethane, polyether block amide, or combinations thereof.

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 sensor such as a thermistor, thermocouple, or semiconductor temperature sensor. The temperature sensor element 110 is connected to the control device via wiring and transmits information indicating measurement results to the control device.

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 regular intervals in the X direction constitute 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.

The area of the sheet 101 in which a certain row sensor element group 110a is arranged and the area of the sheet 101 in which the row sensor element group 110a adjacent to the row sensor element group 110a are arranged are curved or bent arms. 102 is connected. In this embodiment, the arm portion 102 is part of the seat 101 . In this embodiment, the arm portion 102 is formed by providing a cut 103 penetrating through the sheet 101 in a portion of the sheet 101 . The arm portion 102 is extendable in the Y direction, and the temperature sensor unit 100 is pushed outward by the balloon 20 to extend the arm portion 102 from the stowable state of FIG. 4 and transition to the deployed state of FIG.

FIG. 5 schematically shows the temperature sensor unit 100 in an unfolded state. The arms 102, which are curved or bent in the stowable state of FIG. 4, are extended in the unfolded state of FIG. As a result, the distance (D2 described later) between the temperature sensor elements 110 adjacent in the Y direction in the unfolded state of FIG. 5 is longer than the distance in the stowable state of FIG. For example, for 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, such as 6 cm, and the diameter of the sheet 101 is 1 cm to 5 cm, such as 2 cm. is.

Looking at the Y direction in FIG. 5, the temperature sensor elements 110 are arranged at regular intervals in the Y direction in the unfolded state. A plurality of temperature sensor elements 110 arranged at regular intervals in the Y direction constitute a column sensor element group 110b. A plurality of row sensor element groups 110b are arranged in the X direction. FIG. 5 shows three column sensor element groups 110b.

In the unfolded state shown in FIG. 5, the distance (first distance) between the temperature sensor elements 110 adjacent in the X direction is D1, and the distance (second distance) between the temperature sensor elements 110 adjacent in the Y direction is D2. That is, in the unfolded state, the row sensor element groups 110a are arranged at intervals of a first distance D1 in the X direction, and the column sensor element groups 110b are arranged at intervals of a second distance D2 in the Y direction.

The first distance D1 and the second distance D2 are set according to the application. In applications for monitoring the temperature in the esophagus to avoid thermal damage during left atrial ablation, for example, the first distance D1 and the second distance D2 are set between 1 mm and 10 mm, for example 6 mm. This allows the temperature in the esophagus to be monitored with a resolution of a predetermined interval. If the monitored temperature exceeds a predetermined value, the ablation can be stopped, thereby preventing thermal damage to the living tissue.

In vivo, heat tends to diffuse in the direction in which body fluids flow. Since blood vessels around the esophagus run along the esophagus, heat applied to tissues such as the heart around the esophagus tends to diffuse in the direction in which the esophagus extends. Therefore, in the direction in which the esophagus extends, high-density (high-resolution) temperature monitoring must be performed at short intervals to accurately detect the position where the temperature is high due to thermal diffusion. Therefore, in this embodiment, the first distance D1 in the X direction that coincides with the extending direction of the esophagus during use may be configured to be shorter than the second distance D2. For example, the first distance D1 may be greater than or equal to 1 mm and less than 6 mm, and the second distance D2 may be 6 mm.

With this configuration, the temperature sensor elements 110 are densely arranged in the X direction, which coincides with the extending direction of the esophagus during use, to the extent that the position of the inner surface of the esophagus that has reached a high temperature can be accurately detected. In this manner, the temperature sensor unit 100 can accurately detect an increase in tissue temperature due to ablation based on anatomical knowledge so that tissue is not damaged by heat.

FIG. 6 is a schematic sectional view taken along line VI-VI of the temperature sensor unit 100 of FIG. As mentioned above, a plurality of temperature sensor elements 110 are arranged on the sheet 101 . A low-flexibility support substrate 106 may be provided between the sheet 101 and the temperature sensor element 110 to prevent the temperature sensor element 110 from bending and breaking. The support substrate 106 has a Young's modulus that is, for example, 100 to 1,000,000 times that of the flexible sheet 101 .

Due to the low flexibility of the support substrate 106, even if a force to the extent that the sheet 101 is bent causes the sheet 101 to bend, the support substrate 106 to which the same force is applied does not bend. Therefore, the support substrate 106 can prevent damage to the temperature sensor element 110 due to external force such as stress being applied to the temperature sensor element 110 arranged on the support substrate 106 .

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, and the temperature measurement device 1 (see FIGS. 1 and 2) including the temperature sensor unit 100 in the stowable state and the balloon 20 in the deflated state. ) is placed in the esophagus.
(2) The user moves the balloon 20 and the temperature sensor unit 100 to the outside of the shaft 10 via the distal end 11 of the shaft 10 by pushing the guide member 30 in the distal direction while fixing 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) Acquire measurement results from the plurality of temperature sensor elements 110 of the temperature sensor unit 100 .

Instead of (2) above, the user moves the balloon 20 and the temperature sensor unit 100 to the outside of the shaft 10 via the distal end 11 of the shaft 10 by pulling the shaft 10 while fixing the guide member 30. You may let

Also, instead of (3) above, the user may deform the balloon 20 by adding liquid.

As described above, the temperature measurement device 1 according to this embodiment includes the shaft 10, which is an example of a tube, the temperature sensor unit, and the balloon 20, which is an example of a deployment unit. The temperature sensor unit is transitionable between a stowable state in which it is stowed within the shaft 10 and a deployed state in which it is deployed out of the shaft 10 . The balloon 20 transitions the temperature sensor unit from the stowable state to the deployed state. At least part of the temperature sensor unit is configured to be movable with respect to the deployment unit.

According to this configuration, when an external force is applied to the temperature sensor unit 100, the temperature sensor unit 100 and the balloon 20 move relative to each other, thereby reducing the external force applied to the temperature sensor unit 100 and damaging the temperature sensor. The fear can be reduced.

(Second embodiment)
7 and 8 are schematic diagrams showing configuration examples of the temperature sensor unit 200 in the temperature measurement device 2 according to the second embodiment of the present disclosure. FIG. 7 is a plan view schematically showing the temperature sensor unit 200 in the storable state, viewed from the distal side of the axis C (right side when facing the page of FIG. 1). In FIG. 7, distal end 11 of shaft 10 is dot-hatched to clearly distinguish the components.

As shown in FIG. 7, the flexible sheet-like temperature sensor unit 200 is wrapped around the balloon 20 in the storable state. As a result, the radial dimension of the temperature sensor unit 200 can be reduced and the temperature sensor unit 200 can be housed inside the shaft 10 .

An end portion 202 of the temperature sensor unit 200 is fixed to the balloon 20 by adhesion or the like. On the other hand, portions of temperature sensor unit 200 other than end portion 202 are not fixed to balloon 20 and are movable relative to balloon 20 .

As in the first embodiment, the balloon 20 expands after being pushed out from the shaft 10 in the distal direction, thereby pushing the temperature sensor unit 200 outward. As a result, the temperature sensor unit 200 transitions from the stowable state shown in FIG. 7 to the unfolded state shown in FIG.

FIG. 8 is a plan view schematically showing the temperature sensor unit 200 in an unfolded state, viewed from the distal side of axis C. FIG. As the balloon 20 expands, the temperature sensor unit 200 wrapped around the balloon 20 is pushed outward by the balloon 20 while reducing the number of turns. In the unfolded state of FIG. 8, the radial dimension of the temperature sensor unit 200 is larger than in the stowable state shown in FIG. With such a configuration, the temperature sensor unit 200 can come into contact with the inner wall of a tubular organ such as the esophagus in the deployed state.

(Third Embodiment)
9 and 10 are schematic diagrams showing configuration examples of the temperature sensor unit 300 in the temperature measurement device 3 according to the third embodiment of the present disclosure. FIG. 9 is a plan view schematically showing temperature sensor unit 300 in a stowable state, viewed from the distal side of axis C. FIG.

As shown in FIG. 9, in the storable state, the flexible sheet-like temperature sensor unit 300 has a plurality of creases extending in the axial direction, and is folded by being bent at these creases. As a result, the radial dimension of the temperature sensor unit 300 can be reduced and the temperature sensor unit 300 can be housed inside the shaft 10 .

As in the first and second embodiments, the balloon 20 expands after being pushed out from the shaft 10 in the distal direction, thereby pushing the temperature sensor unit 300 outward. As a result, the temperature sensor unit 300 transitions from the stowable state shown in FIG. 9 to the unfolded state shown in FIG.

FIG. 10 is a plan view schematically showing the temperature sensor unit 300 in an unfolded state, viewed from the distal side of axis C. FIG. The folded temperature sensor unit 300 is pushed outward by the expanding balloon 20 . Accordingly, in the unfolded state of FIG. 10, the radial dimension of the temperature sensor unit 300 is larger than in the stowable state shown in FIG.

(Fourth embodiment)
11 and 12 are cross-sectional views schematically showing configuration examples of the temperature measurement device 4 according to the fourth embodiment of the present disclosure. FIG. 11 schematically shows a state in which the temperature sensor unit 400 of the temperature measuring device 4 can be accommodated. FIG. 12 schematically shows an unfolded state of the temperature sensor unit 400. As shown in FIG.

The balloon 420 of the temperature measuring device 4 according to this embodiment has

folds

421 and 422 extending in the axial direction. As shown in FIG. 11, the balloon 420 is folded at

folds

421 and 422 and accommodated within the shaft 10 in the deflated state. Fold lines 421 are sometimes referred to herein as mountain fold lines and fold lines 422 are sometimes referred to as valley fold lines. In the example shown in FIG. 11, there are ten

folds

421 and 422, but the number of folds is not limited to this.

The sheet 401 of the temperature sensor unit 400 is provided on (inside) the inner surface of the balloon 420 . A plurality of temperature sensor elements 110 are arranged on (inside) the inner surface of the sheet 401 . At least part of the temperature sensor unit 400 is physically connected to the inner surface of the balloon 420 by means of adhesion or the like. As a result, the temperature sensor unit 400 can transition from the stowable state shown in FIG. 11 to the expanded state shown in FIG. 11 as the balloon 420 changes from the deflated state to the expanded state.

When the balloon 420 is folded, the sheet 401 provided on the balloon 420 is also folded. The sheet 401 may have creases at positions corresponding to the

creases

421 and 422 of the underlying balloon 420 . As shown in FIG. 11, the temperature sensor element 110 is placed on a portion of the sheet 401 that would not fold even if the balloon 420 were folded. For example, the temperature sensor element 110 is arranged so as not to straddle the

creases

421 and 422 . When the sheet 401 has a fold, the temperature sensor element 110 is arranged so as not to straddle the fold.

By arranging the temperature sensor element 110 on the unfolded portion of the sheet 401 , the temperature sensor unit 400 can be folded into a small size, and more temperature sensor elements 110 can be accommodated within the shaft 10 . In addition, it is possible to prevent the temperature sensor element 110 from being damaged due to a force such as a bending stress applied to the temperature sensor element 110 .

(Fifth embodiment)
A temperature measurement device according to a fifth embodiment of the present disclosure will be described below with reference to FIG. 13 . The temperature measurement device according to the present embodiment includes a temperature sensor unit 500 instead of the temperature sensor unit 100 shown in FIG. 4 in the temperature measurement device 1 according to the first embodiment. The direction of the X-axis shown in FIG. 13 coincides with the direction of the axis C in FIG. 1, and the direction of the Z-axis coincides with the radial direction.

The temperature sensor unit 500 is wound around the axis C so as to cover the balloon 20 in the stowable state. The temperature sensor unit 500 has a plurality of cuts 503 extending in the X direction so as to penetrate the sheet 501 . A plurality of cuts 503 are provided in a portion where the temperature sensor element 110 is not arranged. In the example shown in FIG. 13, the plurality of incisions 503 includes incisions 503a and incisions 503b that are spaced apart from each other in the X direction, and the temperature sensor elements 110 that are adjacent to the

incisions

503a and 503b in the Y direction are: It is arranged between the notch 503a and the notch 503b in the X direction.

When the temperature sensor unit 500 spreads in the Y direction from the storable state to the expanded state, each cut 503 spreads in the Y direction to form an opening, and the sheet 501 between the cuts 503 is deformed. If the temperature sensor element 110 is placed in a region where the sheet 501 is greatly deformed, external force such as bending stress is applied to the temperature sensor element 110 as the sheet 501 deforms, and the temperature sensor element 110 may be damaged.

Therefore, in this embodiment, the temperature sensor element 110 is arranged in the area 505 of the sheet 501 between the

cuts

503a and 503b. Since the area 505 includes a portion without the cut 503, the degree of deformation is smaller than that of other areas when the temperature sensor unit 500 transitions from the stowable state to the deployed state. Thus, in this embodiment, by arranging the temperature sensor element 110 in the area 505, the risk of the temperature sensor element 110 being damaged can be reduced.

(Sixth embodiment)
A temperature measurement device according to a sixth embodiment of the present disclosure will be described below with reference to FIG. 14 . Compared with the fifth embodiment, the temperature sensor unit 600 of the temperature measuring device according to this embodiment has a plurality of notches 603 extending in the Y direction. Each incision 603 may or may not pass through sheet 601 . Although FIG. 14 shows an example in which three or four cuts 603 are spaced apart from each other in the Y direction, the number of cuts 603 is not limited to this.

By having the cut 603 extending in the Y direction in this way, the temperature sensor unit 600 can be flexibly bent around the Y axis and easily housed in the shaft 10 . Moreover, even when the temperature sensor unit 600 is accommodated in the shaft 10, the temperature sensor unit 600 is easily deformed by the cut 603, so that it can be easily inserted into the esophagus through the nose and/or mouth.

Moreover, the temperature sensor unit 600 has a region without the notch 603, and by arranging the temperature sensor element 110 in this region, there is a possibility that an external force such as a large bending stress may be applied to the temperature sensor element 110 due to the deformation of the sheet 601. can be reduced.

(Seventh embodiment)
The temperature measurement device 7 according to the seventh embodiment of the present disclosure will be described below with reference to FIG. 15 . FIG. 15 is a side view schematically showing the balloon 20 and the temperature sensor unit 700 of the temperature measuring device 7. FIG. The temperature sensor unit 700 of the temperature measuring device 7 has an elongated sheet-like shape and is spirally wound around the axis C around the balloon 20 .

The temperature sensor unit 700 may be formed by making a spiral cut that penetrates the cylindrical sheet that wraps the balloon 20 .

Since the temperature sensor unit 700 has a single elongated sheet-like shape, it can be easily accommodated in the shaft 10 and can be easily pulled out of the body via the shaft 10 after use. can.

(Eighth embodiment)
A temperature measuring device according to an eighth embodiment of the present disclosure will be described below with reference to FIGS. 16 to 19. FIG. The main difference between the first embodiment and this embodiment is that the temperature measurement device 1 according to the first embodiment includes a balloon 20 as a deployment unit, whereas the temperature measurement device according to this embodiment includes a basket as a deployment unit. A catheter 820 is provided.

16 and 17 are side views schematically showing configuration examples of the basket catheter 820 of the temperature measurement device according to this embodiment. 16 and 17 show the contracted and expanded states of basket catheter 820, respectively.

The basket catheter 820 has a cylindrical guide member 830 and a plurality of wires 821 each extending in the axial direction and capable of being accommodated within the guide member 830 . Each distal end of the plurality of wires 821 is bound by a binding portion 822, for example. Alternatively, each distal end of the plurality of wires 821 may be bound by means of gluing, fusion, or the like.

As shown in FIG. 17, each wire 821 can be curved and radially expanded to form a cage-like basket portion 823 surrounding a space 824 . Basket catheter 820 thereby transitions to an expanded state. Basket catheter 820 is not limited to the above example, and may employ a known basket catheter configuration.

18 and 19 are cross-sectional views schematically showing configuration examples of the temperature measurement device 8 according to this embodiment. FIG. 18 schematically shows a state in which the temperature sensor unit 800 of the temperature measuring device 8 can be accommodated. FIG. 19 schematically shows an unfolded state of the temperature sensor unit 800. As shown in FIG.

As shown in FIGS. 18 and 19, the sheet 801 of the temperature sensor unit 800 has

folds

802 and 803 extending in the axial direction. As shown in FIG. 18, the sheet 801 is folded at

creases

802 and 803 and accommodated within the shaft 10 in the contracted state.

In the example shown in FIGS. 18 and 19, the plurality of temperature sensor elements 110 are arranged on the outer surface of the sheet 801 on the portion where the

creases

802 and 803 are absent. Note that the temperature sensor element is not limited to the outside of the sheet 801, and may be arranged inside the sheet 801, or may be arranged inside the sheet 801 so that the upper surface and the lower surface are exposed.

When the contracted basket catheter 820 shown in FIG. 18 shifts to the expanded state after moving to the outside of the shaft 10 , the sheet 801 of the temperature sensor unit 800 is spread by the plurality of wires 821 of the basket catheter 820 . As a result, the temperature sensor unit 800 transitions from the stowable state shown in FIG. 18 to the unfolded state shown in FIG.

As described above, in the temperature measurement device 8 according to this embodiment, the basket catheters 820 can extend in the direction from the proximal end 12 to the distal end 11 of the shaft 10 . Basket catheter 820 is bendable from the inside to the outside of shaft 10 . For example, it can bend in a direction from the inside to the outside of the shaft 10 when viewed in cross section in a direction that intersects the direction from the proximal end 12 to the distal end 11 of the shaft 10 .

(Modification)
Although the embodiments of the present disclosure have been described above in detail, the above description is merely an example of the present disclosure in every respect. Various modifications and variations can be made without departing from the scope of the disclosure. For example, the following changes are possible. In addition, below, the same code|symbol is used about the component similar to the said embodiment, and description is abbreviate|omitted suitably about the point similar to the said embodiment. The following modified examples can be combined as appropriate.

(First modification)
In the above embodiments, the esophagus was described as an example of a tubular organ into which the shaft 10 is inserted, but the present disclosure is not limited to this. For example, the tubular organ may be an in vivo lumen, hollow organ, or the like. Specifically, the tubular organ into which the shaft 10 is inserted may be the trachea, lungs, oral cavity, stomach, intestine, external auditory canal, auditory tube, blood vessel, urinary tract, lymphatic vessel, and the like. Tubular organs are not limited to human organs, but may be organs of other organisms.

(Second modification)
In the first embodiment, the sheet 101 that can be deployed by providing the cut 103 has been described (see FIG. 4). However, the sheet 101 is not limited to this, as long as it can be deployed in the radial direction. For example, sheet 101 may be a stent. Alternatively, sheet 101 may be a sheet having a structure similar to that of a stent.

(Third modification)
In the first embodiment, an example in which a low-flexibility support substrate 106 is provided between the sheet 101 and the temperature sensor element 110 in order to prevent the temperature sensor element 110 from being bent and damaged will be described. (See FIG. 6). However, the present disclosure is not limited to this, as long as the temperature sensor element 110 is arranged on the less flexible portion. For example, a first portion of the sheet, on which the temperature sensor element 110 is not arranged, is flexible. On the other hand, the second portion of the sheet, on which the temperature sensor element 110 is arranged, is lower than the first portion to the extent that it does not bend when a force that bends the first portion is applied. It may have flexibility. This configuration also prevents temperature sensor element 110 from being damaged due to external force such as stress being applied to temperature sensor element 110 when the sheet is bent to accommodate in shaft 10 .

(Fourth modification)
Although the balloon 20 having a circular cross-sectional shape has been described in the above embodiment, the shape of the balloon is not limited to circular. For example, as shown in FIG. 20, from a first point on the contour of the cross section perpendicular to the axis C of the balloon 20a, a second point on the contour opposite the first point across the center (C) of the cross section can be obtained. The distance 2a to the point is from the third point on the contour of the cross section, which is different from the first point and the second point, to the fourth point on the contour facing the third point across the center of the cross section. may differ from the distance 2b to the point of . As an example, the cross-sectional shape of the balloon 20a perpendicular to the axis C may be an ellipse with a major axis of 2a and a minor axis of 2b.

For example, left atrial ablation is usually performed with the patient lying down, so the lumen of the esophagus is flat rather than circular when viewed in the direction in which the esophagus extends. Normal. Therefore, the elliptical shape of the cross section allows the balloon 20a and the temperature sensor unit provided thereon to adhere to the inner wall of the esophagus when inflated, compared to the case of a circular shape. This makes it possible to accurately measure the temperature of the inner wall of the esophagus.

The expansion units such as the balloons mentioned in the above embodiments may be contracted after being expanded. By contracting the expansion unit, it is possible to avoid expanding the esophagus in the width direction. Also, by contracting the deployment unit, it is possible to avoid pressing the inner wall of the esophagus toward the heart, particularly the left atrium, by the deployment unit. As described above, since the adhesion between the heart and the esophagus is low, it is possible to prevent excessive heat from being transmitted from the heart to the esophagus when ablating the heart.

1 to 4, 7, 8 temperature measuring device 10 shaft 11 distal end 12

proximal end

20, 20a, 420 balloon 21 proximal end 22 contact portion 30 guide member 31

gas flow path

100, 200, 300, 400, 500, 600, 700, 800

Temperature sensor unit

101, 401, 501, 601, 801 Sheet 102 Arm 106 Support substrate 110 Temperature sensor element 110a Row sensor element group 110b Column

sensor element group

421, 422

Folds

802, 803 Folds 820 Basket catheter 821 Wire 822 Binding Part 823 Basket Part 824 Space 830 Guide Member

Claims

a tube;
a temperature sensor unit capable of transitioning between a stowable state in which it can be stowed inside the tube and a deployed state in which it is deployed outside the tube;
a deployment unit that transitions the temperature sensor unit from the stowable state to the deployed state;
At least part of the temperature sensor unit is configured to be movable with respect to the deployment unit,
Temperature measuring device.
The temperature measurement device according to claim 1, wherein a part of said temperature sensor unit is fixed to said deployment unit.
The temperature sensor unit is arranged around at least a portion of the deployment unit,
At least part of the deployment unit is fixed to the temperature sensor unit,
The deployment unit is deformable in a direction from the inside to the outside of the pipe when viewed in cross section in a direction that intersects the direction from one end to the other end of the pipe.
The temperature measuring device according to claim 1 or 2.
The temperature measurement device according to any one of claims 1 to 3, wherein the temperature sensor unit includes a flexible sheet having a first fold.
The temperature measuring device according to claim 4, wherein the temperature sensor unit has a temperature sensor element arranged on the sheet so as not to straddle the first fold.
The temperature measurement device according to any one of claims 1 to 5, wherein the deployment unit is a balloon.
the balloon having a second fold;
The temperature sensor unit has a temperature sensor element arranged so as not to straddle the second fold,
The temperature measuring device according to claim 6.
Each of the deployment units can extend in a direction from one end to the other end of the tube, and extends from the inside to the outside of the tube when viewed in cross section in a direction intersecting the direction from one end to the other end of the tube. including a plurality of wires that are bendable in the facing direction;
A temperature measuring device according to any one of claims 1 to 5.
The temperature sensor unit has a sheet and a temperature sensor element arranged on the sheet,
The sheet is arranged to surround the plurality of wires when viewed from one end to the other end of the tube,
wherein the temperature sensor element is positioned between the plurality of wires;
The temperature measuring device according to claim 8.
The temperature sensor unit has a sheet and a temperature sensor element arranged on the sheet,
The sheet has a cut in a portion where the temperature sensor element is not arranged,
A temperature measuring device according to any one of claims 1 to 9.
10. The temperature sensor unit according to any one of claims 1 to 9, wherein the temperature sensor unit is housed in the tube in a rolled state and has a plurality of cuts extending substantially parallel in a direction from one end to the other end of the tube. The temperature measuring device according to .
The temperature sensor unit has a sheet and a temperature sensor element arranged on the sheet,
The plurality of cuts are provided in a portion where the temperature sensor element is not arranged.
A temperature measurement device according to claim 11 .
The plurality of cuts includes a first cut and a second cut that are spaced apart and adjacent to each other in a direction from one end to the other end of the tube;
The temperature sensor element is arranged between the first cut and the second cut in a direction from one end to the other end of the tube.
13. A temperature measuring device according to claim 12.
10. The temperature sensor unit according to any one of claims 1 to 9, wherein said temperature sensor unit is housed in said tube in a rolled state and has a plurality of cuts extending in a direction crossing a direction from one end of said tube to the other end. The temperature measuring device according to 1.
The temperature sensor unit has a sheet and a temperature sensor element arranged on the sheet,
The plurality of cuts are provided in a portion where the temperature sensor element is not arranged.
15. A temperature measuring device according to claim 14.
The temperature sensor unit includes a sheet spirally wound around the deployment unit,
A temperature measuring device according to any one of claims 1 to 9.
The temperature sensor unit has a sheet and a temperature sensor element arranged on the sheet,
The sheet has a first portion where the temperature sensor element is not arranged and a second portion where the temperature sensor element is arranged,
the flexibility of the first portion is greater than the flexibility of the second portion;
A temperature measuring device according to any one of claims 1 to 16.
The distance from a first point on the contour of the section of the deployment unit that intersects the axis of the tube to a second point on the contour that faces the first point across the center of the section is 1. Different from the distance from a third point of the contour that is different from the first point and the second point to a fourth point of the contour that faces the third point across the center of the cross section. 18. The temperature measuring device according to any one of 1 to 17.
The temperature measurement device according to any one of claims 1 to 18, wherein the temperature sensor unit has a diameter larger than that of the tube in the deployed state.