WO2023171462A1

WO2023171462A1 - Varicose vein cooling catheter and varicose vein cooling device

Info

Publication number: WO2023171462A1
Application number: PCT/JP2023/007272
Authority: WO
Inventors: 健金藤
Original assignee: 株式会社カネカ
Priority date: 2022-03-09
Filing date: 2023-02-28
Publication date: 2023-09-14

Abstract

The present invention addresses the problem of providing a varicose vein treatment device that can be used easily. The present invention also addresses the problem of providing a medical device with which it is possible to realize varicose vein treatment having minimal side effects. The present invention provides a varicose vein cooling catheter having a shaft that extends in the longitudinal direction, the shaft having a first lumen for sucking venous blood by means of a negative pressure and a second lumen that extends in the longitudinal direction and into which a cooling member is inserted. The first lumen has a first distal opening at the distal part thereof. In a cross-section perpendicular to the longitudinal direction in a region on the proximal side relative to the proximal end of the first distal opening of the shaft, the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen. The present invention also provides a varicose vein cooling balloon catheter having a shaft extending in the longitudinal direction and a balloon provided at the distal part of the shaft. The shaft has a fluid-feeding lumen that extends in the longitudinal direction and that feeds a fluid to the balloon, and a fluid discharge lumen that extends in the longitudinal direction and that discharges the fluid from the balloon. The balloon has a cooling fluid in the interior thereof.

Description

Varicose vein cooling catheter and varicose vein cooling device

The first invention of the present application relates to a varicose vein cooling catheter, a varicose vein cooling device, and a varicose vein cooling method. A second invention of the present application relates to a balloon catheter for cooling varicose veins, a device for cooling varicose veins, and a method for cooling varicose veins.

Varicose veins, which are caused by partially thickened veins in people's lower limb veins, may occur. To date, various devices for treating varicose veins are known. For example, U.S. Pat. No. 5,002,000 describes a device for delivering intravascular drugs including: a) a first catheter tube having a proximal end, a distal end, and a fluid lumen extending from the proximal end to the distal end; c) an inflatable balloon connected to the distal end of the first catheter tube and in communication with the fluid lumen; c) a second catheter tube having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; a second catheter tube, the first catheter tube extending within a lumen of the second catheter tube; and d) a self-expanding balloon connected to a distal end of the second catheter tube; a self-expanding balloon with the first catheter tube extending therein; e) a third catheter tube having a proximal end, a distal end, and a lumen extending from the proximal end to the distal end; a third catheter tube, the second catheter tube extending into a lumen of the third catheter tube, at least one of the second catheter tube and the third catheter tube receiving an intravascular drug; A device is disclosed for delivering intravascular drugs to the location of the self-expanding balloon.

Special Publication No. 2004-533893

When treating varicose veins using the device of Patent Document 1 as described above, the device injects a drug into the varicose veins, rubs the drug into the inner wall of the varicose veins using a balloon, etc., and then applies a compression bandage to the affected area. The blood was removed from the varicose veins by wrapping them around the veins and compressing the affected area, causing the vein walls to fuse together. However, there were large differences in skill among practitioners when it came to techniques for rubbing the drug into the inner wall of varicose veins and applying pressure to the affected area. Therefore, in recent years, there has been a demand for the development of devices for treating varicose veins that can be easily used. The first invention of the present application has been made with attention to the above-mentioned problems, and its purpose is to provide a device for treating varicose veins that can be easily used. Another purpose is to provide a new treatment method for varicose veins.

When treating varicose veins using the device of Patent Document 1 as described above, the device injects a drug into the varicose veins, rubs the drug into the inner wall of the varicose veins using a balloon, etc., and then applies a compression bandage to the affected area. The blood was removed from the varicose veins by wrapping them around the veins and compressing the affected area, causing the vein walls to fuse together. Although varicose veins can be treated using this method, side effects may occur due to the drug. In addition, so-called ablation, which cauterizes varicose veins by applying a high-frequency current, may be performed as a treatment for varicose veins, but ablation has a large effect on surrounding tissue due to heating, and since anesthesia is used, side effects may occur due to anesthesia. there were. The second invention of the present application has been made with attention to the above-mentioned problems, and its purpose is to provide a medical device that can treat varicose veins with fewer side effects. Another objective is to provide a method for treating varicose veins with fewer side effects.

The varicose vein cooling catheter according to the embodiment of the first invention of the present application, which can solve the above problems, is as follows.
[1] It has a shaft extending in the longitudinal direction,
The shaft is
a first lumen extending in the longitudinal direction and sucking venous blood by negative pressure;
a second lumen extending in the longitudinal direction and into which a cooling member is inserted;
The first lumen has a first distal opening at a distal portion, and in a cross section perpendicular to the longitudinal direction in a region proximal to the proximal end of the first distal opening of the shaft, A varicose vein cooling catheter in which the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen.

Using the catheter, varicose veins can be contracted by sucking venous blood from the first lumen, and a cooling member is inserted into the varicose veins from the second lumen, and the cooling member causes the contraction. By cooling the varicose veins, the shape of the varicose veins can be maintained in a contracted state. Varicose veins can be treated by such easy operations. The varicose vein cooling catheter according to the embodiment is preferably one of the following [2] to [8].
[2] The varicose vein cooling catheter according to [1], wherein the second lumen has a second distal opening located more distally than the distal end of the first distal opening.
[3] The shaft has an inclined surface that is inclined with respect to the longitudinal direction, the inclined surface has the first distal opening, and the distal end of the inclined surface is the proximal end. The varicose vein cooling catheter according to [1] or [2], which is closer to the second lumen than the second lumen.
[4] The varicose vein cooling catheter according to [3], wherein the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen at the proximal end of the inclined surface.
[5] The varicose vein according to any one of [1] to [4], wherein the shaft has a first tube having the first lumen and a second tube having the second lumen. Cooling catheter.
[6] The distal end of the first tube is located more proximally than the distal end of the second tube, and the proximal end of the first tube is more proximal than the second tube. The varicose vein cooling catheter according to [5], which is located on the distal side.
[7] The second tube has a flattened portion at least at the distal end,
In a cross section perpendicular to the longitudinal direction of the flat part, the maximum length of the flat part in a first direction passing through the center of the first tube and the center of the second tube is the maximum length of the flat part in the first direction. The catheter for cooling varicose veins according to [5] or [6], which is shorter than the maximum length of the flat portion in the second direction perpendicular to the varicose vein cooling catheter.
[8] The varicose vein cooling catheter according to any one of [1] to [7], wherein the shaft does not have a balloon.

The device for cooling varicose veins according to the embodiment of the first invention of the present application, which can solve the above problems, is as described in [9] below.
[9] A catheter having a longitudinally extending shaft;
It has a cooling member,
The device for cooling varicose veins, wherein the shaft extends in the longitudinal direction and has a first lumen for sucking venous blood by negative pressure.

Using the device for cooling varicose veins, varicose veins can be contracted by sucking venous blood from the first lumen, and a cooling member is further inserted into the varicose veins, and the varicose veins are contracted by the cooling member. By cooling the varicose veins, the shape of the varicose veins can be maintained in a contracted state. Varicose veins can be treated by such easy operations. Further, the device for cooling varicose veins according to the embodiment is preferably one of the following [10] to [13].
[10] The device for cooling varicose veins according to [9], wherein the cooling member is elongated and has a flattened portion at least at the distal end.
[11] The catheter is the varicose vein cooling catheter according to any one of [1] to [8],
The device for cooling varicose veins according to [9] or [10], wherein the cooling member is inserted into the second lumen.
[12] The varicose vein cooling device according to any one of [9] to [11], wherein a suction device is connected directly or indirectly to the proximal end of the first lumen.
[13] The device for cooling varicose veins according to any one of [9] to [12], further comprising a temperature control member that is connected to the cooling member and controls the temperature of the cooling portion of the cooling member.

The method for cooling varicose veins according to the embodiment of the first invention of the present application, which can solve the above problems, is as described in [14b] below. This makes it possible to provide a new treatment method for varicose veins. Further, the method for cooling varicose veins according to the embodiment is preferably the following [15b].
[14b] A method for cooling varicose veins, including the step of inserting a cooling member into a vein to cool the varicose veins possessed by the vein.
[15b] The method for cooling varicose veins according to [14b], which includes the step of sucking venous blood within the varicose veins.

As in any of [14] to [26] below, each configuration according to the embodiment of the first invention of the present application is combined with each configuration according to the embodiment of the second invention of the present application, which will be described later. It's okay.
[14] The cooling member includes a shaft extending in the longitudinal direction;
a balloon provided at a distal portion of the shaft, the balloon catheter comprising:
The shaft of the cooling member is
a fluid supply lumen extending in the longitudinal direction and supplying fluid to the balloon;
a fluid discharge lumen extending in the longitudinal direction and discharging fluid from the balloon;
The device for cooling varicose veins according to [9], wherein the balloon has a cooling fluid inside.
[15] The device for cooling varicose veins according to [14], wherein in a cross section perpendicular to the longitudinal direction, the cross-sectional area of the fluid supply lumen is smaller than the cross-sectional area of the fluid discharge lumen.
[16] The device for cooling varicose veins according to [14] or [15], wherein the shaft of the cooling member has a cooling part inside the balloon that cools the fluid.
[17] The varicose vein cooling device according to any one of [14] to [16], wherein the cooling member is inserted into the first lumen.
[18] The shaft of the catheter has a second lumen extending in the longitudinal direction and supplying an occluder to occlude the varicose veins. [14] - [17] Varicose vein cooling device.
[19] The first lumen has a first distal opening at a distal portion, and a cross section perpendicular to the longitudinal direction in a region proximal to the proximal end of the first distal opening of the shaft. The device for cooling varicose veins according to [18], wherein the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen.
[20] The varicose vein cooling device according to [19], wherein the second lumen has a second distal opening located more distally than the distal end of the first distal opening.
[21] The shaft of the catheter has an inclined surface that is inclined with respect to the longitudinal direction, the inclined surface has the first distal opening, and the distal end of the inclined surface has a The varicose vein cooling device according to [19] or [20], which is closer to the second lumen than the proximal end.
[22] The device for cooling varicose veins according to [21], wherein at the proximal end of the inclined surface, the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen.
[23] The shaft of the catheter has a first tube having the first lumen and a second tube having the second lumen, according to any one of [18] to [22]. device for cooling varicose veins.
[24] The distal end of the first tube is located more proximally than the distal end of the second tube, and the proximal end of the first tube is located more proximally than the proximal end of the second tube. The device for cooling varicose veins according to [23], located on the distal side.
[25] The second tube has a flattened portion at least at the distal end,
In a cross section perpendicular to the longitudinal direction of the flat part, the maximum length of the flat part in a first direction passing through the center of the first tube and the center of the second tube is the maximum length of the flat part in the first direction. The device for cooling varicose veins according to [23] or [24], wherein the device is shorter than the maximum length of the flat portion in the second direction perpendicular to the varicose vein cooling device.
[26] The varicose vein cooling device according to any one of [14] to [25], wherein the shaft of the catheter does not have a balloon.

The balloon catheter for cooling varicose veins according to the embodiment of the second invention of the present application, which can solve the above problems, is as follows.
[1a] A shaft extending in the longitudinal direction;
a balloon provided at a distal portion of the shaft, the balloon catheter comprising:
The shaft is
a fluid supply lumen extending in the longitudinal direction and supplying fluid to the balloon;
a fluid discharge lumen extending in the longitudinal direction and discharging fluid from the balloon;
The balloon has a cooling fluid inside the balloon catheter for cooling varicose veins.

By expanding the balloon of the balloon catheter inside the varicose vein and cooling the varicose vein from within, cells on the inner wall of the varicose vein can be necrotized, and the varicose vein can eventually regress. According to such cooling, an inflammatory reaction is less likely to occur than when treating varicose veins by using a hardening agent or by ablation, so that side effects associated with the treatment can be reduced. The balloon catheter for cooling varicose veins according to the embodiment is preferably [2a] or [3a] below.
[2a] The balloon catheter for cooling varicose veins according to [1a], wherein in a cross section perpendicular to the longitudinal direction, the cross-sectional area of the fluid supply lumen is smaller than the cross-sectional area of the fluid discharge lumen.
[3a] The balloon catheter for cooling varicose veins according to [1a] or [2a], wherein the shaft has a cooling part inside the balloon that cools the fluid.

A device for cooling varicose veins according to an embodiment of the second invention of the present application that can solve the above problem is as shown in [4a] below.
[4a] The varicose vein cooling balloon catheter according to any one of [1a] to [3a];
a catheter having a longitudinally extending shaft;
The shaft of the catheter extends in the longitudinal direction and has a first lumen for aspirating venous blood with negative pressure.

By using the varicose vein cooling device to inflate the balloon of the balloon catheter within the varicose vein and cooling the varicose vein from within, side effects associated with the treatment can be reduced. Furthermore, by suctioning venous blood from the first lumen, varicose veins can be contracted, and treatment efficiency can be improved. Further, the device for cooling varicose veins according to the embodiment is preferably one of the following [5a] to [14a].
[5a] The varicose vein cooling device according to [4a], wherein the balloon catheter is inserted into the first lumen.
[6a] The varicose vein according to [4a] or [5a], wherein the shaft of the catheter has a second lumen extending in the longitudinal direction and supplying an occluder to occlude the varicose vein. Cooling device.
[7a] The first lumen has a first distal opening at a distal portion, and a cross section perpendicular to the longitudinal direction in a region proximal to the proximal end of the first distal opening of the shaft. The device for cooling varicose veins according to [6a], wherein the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen.
[8a] The device for cooling varicose veins according to [7a], wherein the second lumen has a second distal opening located more distally than the distal end of the first distal opening.
[9a] The shaft of the catheter has an inclined surface that is inclined with respect to the longitudinal direction, the inclined surface has the first distal opening, and the distal end of the inclined surface has a The device for cooling varicose veins according to any one of [7a] and [8a], which is closer to the second lumen than the proximal end.
[10a] The varicose vein cooling device according to [9a], wherein at the proximal end of the inclined surface, the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen.
[11a] The shaft of the catheter has a first tube having the first lumen and a second tube having the second lumen, according to any one of [6a] to [10a]. device for cooling varicose veins.
[12a] The distal end of the first tube is located more proximally than the distal end of the second tube, and the proximal end of the first tube is located more proximally than the proximal end of the second tube. The device for cooling varicose veins according to [11a] located on the distal side.
[13a] The second tube has a flattened portion at least at the distal end,
In a cross section perpendicular to the longitudinal direction of the flat part, the maximum length of the flat part in a first direction passing through the center of the first tube and the center of the second tube is the maximum length of the flat part in the first direction. The device for cooling varicose veins according to [11a] or [12a], wherein the device is shorter than the maximum length of the flat portion in the second direction perpendicular to the varicose vein cooling device.
[14a] The varicose vein cooling device according to any one of [4a] to [13a], wherein the shaft of the catheter does not have a balloon.

The method for cooling varicose veins according to the embodiment of the second invention of the present application, which can solve the above problems, is as follows [15a].
[15a] Inserting the balloon of the balloon catheter into the vein,
A method for cooling varicose veins, comprising the step of cooling the varicose veins in the veins by supplying a cooled fluid into the balloon and/or cooling the fluid supplied within the balloon.

According to this method of expanding the balloon of the balloon catheter inside the varicose veins and cooling the varicose veins from the inside, varicose veins can be treated with few side effects. Furthermore, the method for cooling varicose veins according to the embodiment is preferably the following [16a] or [17a].
[16a] The method for cooling varicose veins according to [15a], which includes the step of sucking venous blood within the varicose veins.
[17a] The method for cooling varicose veins according to [15a] or [16a], which includes the step of supplying into the varicose vein a blockage material that occludes the varicose vein.

According to the first invention of the present application, with the above configuration, it is possible to provide a device for treating varicose veins that can be easily used. Further, according to the first invention of the present application, a new method for treating varicose veins can be provided.

According to the second invention of the present application, with the above configuration, it is possible to provide a medical device that can implement varicose vein treatment with few side effects. Further, according to the second invention of the present application, a method for treating varicose veins with fewer side effects can be provided.

FIG. 1 is a side view of a varicose vein cooling catheter according to an embodiment. FIG. 2 is a partially enlarged view of FIG. 1. FIG. 3 is a schematic diagram of the varicose vein cooling catheter when a cooling member is inserted into the varicose vein via the varicose vein cooling catheter according to the embodiment. FIG. 4 is a schematic diagram of the varicose vein cooling catheter shown in FIG. 3 when venous blood is suctioned and cooled by the varicose vein cooling catheter. FIG. 5 is a cross-sectional view showing the AA cross section of the varicose vein cooling catheter of FIG. FIG. 6 is a sectional view showing a modification of the BB cross section of the varicose vein cooling catheter of FIG. FIG. 7 is a sectional view showing the CC cross section of the varicose vein cooling catheter of FIG. 2. FIG. 8 is a cross-sectional view showing a modified example of the CC cross section of the varicose vein cooling catheter of FIG. FIG. 9 is a side view of a device for cooling varicose veins according to an embodiment. FIG. 10 is a schematic diagram of a cooling member, a temperature control member, etc. FIG. 11 is a cross-sectional view of the cooling member of FIG. 10. FIG. 12 is a sectional view showing the DD cross section of the cooling member in FIG. FIG. 13 is a sectional view showing a modification of the DD cross section of the cooling member in FIG. FIG. 14 is a side view of a modification of the distal end of the cooling member of FIG. 10. FIG. 15 is a side view of a modification of the distal end of the cooling member of FIG. 10. FIG. 16 is a schematic diagram of a cooling member, a heating member, a temperature sensor, a temperature indicator, a temperature control member, etc. FIG. 17 is a side view of the balloon catheter for cooling varicose veins according to the embodiment. FIG. 18 is a cross-sectional view taken along the line XX in FIG. 17. FIG. 19 is a sectional view showing a modification of the XX section in FIG. 17. FIG. 20 is a schematic diagram of the varicose vein cooling balloon catheter according to the embodiment of FIG. 17 and its peripheral equipment. FIG. 21 is a side view of a balloon catheter for cooling varicose veins according to another embodiment. FIG. 22 is a sectional view showing the YY cross section of FIG. 21. FIG. 23 is a side view of the catheter of the varicose vein cooling device according to the embodiment. FIG. 24 is a partially enlarged view of the catheter of FIG. 23. FIG. 25 is a schematic view of the varicose vein cooling balloon catheter inserted into the varicose vein via the catheter of FIG. 23. FIG. 26 is a schematic diagram when the balloon of the varicose vein cooling balloon catheter of FIG. 25 is inflated to cool the inside of the varicose vein. FIG. 27 is a schematic diagram of the varicose vein cooling balloon catheter of FIG. 26 when it is recovered. FIG. 28 is a schematic diagram of the varicose vein cooling device of FIG. 27 when venous blood is suctioned by the catheter and an occluder is supplied into the varicose vein. FIG. 29 is a cross-sectional view showing the AA cross section of the catheter of FIG. 24. FIG. 30 is a sectional view showing a modification of the BB cross section of the catheter in FIG. 24. FIG. 31 is a sectional view showing the cross section of the catheter shown in FIG. 24 taken along the line CC. FIG. 32 is a cross-sectional view showing a modification of the cross-section taken along the line CC of the catheter shown in FIG. 24. FIG. 33 is a side view showing the distal portion of a modified example of the varicose vein cooling balloon catheter of FIG. 17. FIG. 34 is an axial cross-sectional view at the distal end of a variation of the second tube of the catheter of FIG. 23; FIG. 35 is an axial cross-sectional view at the distal end of a variation of the second tube of the catheter of FIG. 23; FIG. 36 is a schematic diagram of a varicose vein cooling balloon catheter of a varicose vein cooling device according to another embodiment and its peripheral equipment.

In the following, the present invention will be explained in more detail based on the following embodiments, but the present invention is not limited by the following embodiments, and may be modified as appropriate within the scope that fits the spirit of the above and below. Of course, it is also possible to implement in addition, and all of them are included in the technical scope of the present invention. In addition, in each drawing, member numbers etc. may be omitted for convenience, but in such a case, the specification and other drawings shall be referred to. Further, the dimensions of various members in the drawings are given priority to help understanding the features of the present invention, and therefore may differ from actual dimensions.

A catheter for cooling varicose veins according to an embodiment of the first invention of the present application has a shaft extending in the longitudinal direction, and the shaft extends in the longitudinal direction and has a first tube that sucks venous blood using negative pressure. a second lumen extending longitudinally into which the cooling member is inserted, the first lumen having a first distal opening at a distal portion and a first distal opening of the shaft; In a section perpendicular to the longitudinal direction in a region proximal to the proximal end of the opening, the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen.

Using the catheter, varicose veins can be contracted by sucking venous blood from the first lumen, and a cooling member is inserted into the varicose veins from the second lumen, and the cooling member causes the contraction. By cooling the varicose veins, the shape of the varicose veins can be maintained in a contracted state. Varicose veins can be treated by such easy operations. In particular, the catheter can be suitably used for treating varicose veins in the lower extremities.

Hereinafter, a varicose vein cooling catheter according to an embodiment will be described with reference to FIGS. 1 to 8. FIG. 1 is a side view of a varicose vein cooling catheter according to an embodiment, and FIG. 2 is a partially enlarged view thereof. FIG. 3 is a schematic diagram of the varicose vein cooling catheter when a cooling member is inserted into the varicose vein via the varicose vein cooling catheter according to the embodiment, and FIG. 4 is a schematic diagram of the varicose vein cooling catheter by sucking venous blood FIG. 2 is a schematic diagram of the varicose vein cooling catheter. 5 shows the AA cross section in FIG. 2, FIG. 6 shows a modification of the BB cross section in FIG. 2, FIG. 7 shows the CC cross section in FIG. 2, and FIG. 8 shows the C-- A modification of the C section is shown.

As shown in FIGS. 1 and 2, the varicose vein cooling catheter 1 according to the embodiment has a shaft 10 extending in the longitudinal direction X, and the shaft 10 extends in the longitudinal direction The first lumen 11 has a first lumen 11 that sucks venous blood, and a second lumen 12 that extends in the longitudinal direction X and into which a cooling member is inserted. It has an opening 13.

As shown in FIGS. 3 and 4, the venous blood 92 within the varicose veins 91 can be sucked through the first distal opening 13 of the first lumen 11 to shrink the varicose veins 91. Further, by exposing the distal end portion 3b of the cooling member 3 toward the distal side from the distal portion of the second lumen 12, the varicose veins 91 can be cooled by the distal end portion 3b. Note that the first lumen 11 only needs to have the first distal opening 13 at its distal portion, and preferably has the first distal opening 13 at its distal end.

In this specification, the proximal side of the shaft 10 means the side near the user's hand in the extending direction of the shaft 10, and the distal side of the shaft 10 means the proximal side in the extending direction of the shaft 10. means the opposite side. Further, the extending direction of the shaft 10 is referred to as a longitudinal direction X.

As shown in FIGS. 1, 2, and 5, the cross section of the second lumen 12 is taken in a cross section perpendicular to the longitudinal direction The area is smaller than the cross-sectional area of the first lumen 11. This makes it easier to prevent the venous blood 92 from flowing into the second lumen 12. Furthermore, since the cross-sectional area of the first lumen 11 is relatively large, the venous blood 92 can be easily sucked.

As shown in FIG. 1, the region where the cross-sectional area of the second lumen 12 in the direction perpendicular to the longitudinal direction It is preferably an area proximal to the proximal end 13A and within 1 cm from the proximal end 13A, more preferably an area within 5 cm from the

proximal end

13A, and 10 cm from the proximal end 13A. It is more preferable that the area be within 20 cm of the proximal end 13A, and even more preferably that the area be within 20 cm from the proximal end 13A. Further, it is particularly preferable that the region is a region proximal to the proximal end 13A of the first distal opening 13 of the shaft 10 and extending to the proximal end 10A of the shaft 10. That is, it is particularly preferable that the region is the entire region proximal to the proximal end 13A of the first distal opening 13 of the shaft 10. Note that when the varicose vein cooling catheter 1 has the handle member 30, the proximal end 10A of the shaft 10 corresponds to the distal end of the handle member 30.

In a cross section perpendicular to the longitudinal direction , more preferably 0.5 times or less. On the other hand, the cross-sectional area of the second lumen 12 is preferably 0.01 times or more, more preferably 0.05 times or more, the cross-sectional area of the first lumen 11.

The shapes of the first lumen 11 and the second lumen 12 in a cross section perpendicular to the longitudinal direction X are preferably circular, elliptical, polygonal, or rounded polygonal, and are circular or elliptical. It is more preferable. This makes it easier to absorb the venous blood 92 from the first lumen 11, and also makes it easier to insert the cooling member 3 into the second lumen 12. Further, the outer edges of the first lumen 11 and the second lumen 12 in the cross section preferably include a straight line, a curved line, or a straight line and a curved line, and more preferably include a curved line, or a straight line and a curved line, and preferably include a curved line or a straight line and a curved line, respectively. Even more preferably, it consists of: Note that the cross-sectional shapes of the first lumen 11 and the second lumen 12 may be the same or different.

For example, a suction device may be used to suction the venous blood 92 from the first lumen 11 using negative pressure. Thereby, blood can be easily removed from the first lumen 11. For details of the suction device, refer to the description of the suction device 2 of the varicose vein cooling device 100 described later. Further, for details of the cooling member 3 inserted into the second lumen 12, refer to the description of the cooling member 3 of the varicose vein cooling device 100 described later.

As shown in FIGS. 2 and 3, the second lumen 12 preferably has a second distal opening 14 located more distally than the distal end 13B of the first distal opening 13. The distal side refers to the distal side of the shaft 10. The second distal opening 14 is located more distally than the distal end 13B of the first distal opening 13, thereby making it easier to insert the distal end 3b of the cooling member 3 into the varicose vein 91. I can do it.

The distance from the distal end 13B of the first distal opening 13 to the second distal opening 14 in the longitudinal direction X is 1.5 of the diameter of the first lumen 11 at the proximal end 13A of the first distal opening 13. It is preferable that it is twice or more. Thereby, damage to the cooling member 3 due to suction can be easily avoided. The magnification is more preferably 2.0 times or more, more preferably 5.0 times or more. On the other hand, the magnification is preferably 50 times or less, more preferably 20 times or less. This allows the cooling member 3 to easily cool the area within the varicose vein 91 that has become narrow due to the suction from the first distal opening 13 .

As shown in FIGS. 1 and 2, the shaft 10 has an inclined surface 19 that is inclined with respect to the longitudinal direction X, and the inclined surface 19 has a first distal opening 13. Preferably, the distal end 19B is closer to the second lumen 12 than the proximal end 19A. As a result, as shown in FIG. 4, the inner wall of the varicose vein 91 can be brought into close contact with the distal end portion 10b of the shaft 10 when venous blood 92 is aspirated, and the volume of the varicose vein 91 can be easily reduced. can. Furthermore, since the inclined surface 19 has the first distal opening 13, the area of the first distal opening 13 can be increased, making it easier to efficiently aspirate the venous blood 92. .

The inclined surface 19 is preferably a flat surface, a curved surface, or a combination of a flat surface and a curved surface, and more preferably a flat surface. This makes it easier to bring the inner wall of the varicose vein 91 into close contact with the distal end portion 10b of the shaft 10 when venous blood 92 is aspirated.

At the proximal end 19A of the inclined surface 19, the cross-sectional area of the second lumen 12 is preferably smaller than the cross-sectional area of the first lumen 11. When inserting the shaft 10 into the vein 90, the load due to insertion resistance tends to concentrate near the proximal end 19A, but as a result of the load being relieved by the first lumen 11 having a large area, The inner cavity 12 becomes difficult to deform. Note that these cross-sectional areas are cross-sectional areas in a cross section perpendicular to the longitudinal direction X.

It is preferable that the cross-sectional shapes of the first lumen 11 at the proximal end 19A of the inclined surface 19 and the proximal end 10A of the shaft 10 are the same shape. Moreover, it is more preferable that the cross-sectional shape of the first inner cavity 11 from the proximal end 19A of the inclined surface 19 to the proximal end 10A of the shaft 10 is constant. This makes it easier to suction from the first lumen 11. Note that the cross-sectional shape is a shape in a cross section perpendicular to the longitudinal direction X.

It is preferable that the cross-sectional shapes of the second lumen 12 at the proximal end 19A of the inclined surface 19 and the proximal end 10A of the shaft 10 are the same shape. Further, it is more preferable that the cross-sectional shape of the second inner cavity 12 from the proximal end 19A of the inclined surface 19 to the proximal end 10A of the shaft 10 is constant. This allows the cooling member 3 to be easily inserted into the second inner cavity 12. Note that the cross-sectional shape is a shape in a cross section perpendicular to the longitudinal direction X.

As shown in FIGS. 1 and 2, the shaft 10 preferably includes a first tube 21 having a first lumen 11 and a second tube 22 having a second lumen 12. This allows the first lumen 11 and the second lumen 12 to have different characteristics.

As shown in FIG. 1, the distal end 21B of the first tube 21 is located more proximally than the distal end 22B of the second tube 22, and the proximal end 21A of the first tube 21 is located closer to the second tube 22. It is preferable to be located on the distal side of the proximal end 22A. As a result, the suction path for the venous blood 92 can be shortened, so that the venous blood 92 can be efficiently suctioned. The proximal side and distal side are the proximal side and distal side in the longitudinal direction X.

The second tube 22 is preferably linear from the proximal end 22A to the distal end 22B. This allows the cooling member 3 to be easily inserted into the second tube 22.

The outer diameter of the second tube 22 distal to the distal end 21B of the first tube 21 is preferably smaller than the outer diameter of the first tube 21 at the proximal end 19A of the inclined surface 19. This makes it easier to prevent the venous blood 92 from flowing into the second tube 22. Furthermore, it is more preferable that the distal end 22B of the second tube 22 is located further distally than the distal end 21B of the first tube 21. This allows the varicose veins 91 in the portion distal to the first tube 21 to be easily contracted during suction using the first tube 21 .

As shown in FIGS. 1, 2, 5, etc., the second tube 22 is tubular, but it is preferable that the second tube 22 has a flattened portion at least at the distal end 22b. . Since at least a portion of the second tube 22 is flat, the volume of the varicose veins 91 can be easily reduced when the venous blood 92 is suctioned.

As shown in FIG. 6, the second tube 22 has a flat part 22d at least at the distal end part 22b, and the center of the first tube 21 in the cross section perpendicular to the longitudinal direction X of the flat part 22d. The maximum length L1 of the flat portion 22d in the first direction D1 passing through the center of the second tube 22 is longer than the maximum length L2 of the flat portion 22d in the second direction D2 perpendicular to the first direction D1. It is more preferable that the length is also short. Thereby, when suctioning the venous blood 92, the varicose veins 91 can be easily contracted in the first direction D1. The second tube 22 may have a flat portion 22d over its entire length.

The shape of the outer edge of the flat portion 22d of the second tube 22 in a cross section perpendicular to the longitudinal direction preferable.

The first tube 21 and the second tube 22 may or may not be directly fixed. For example, the first tube 21 and the second tube 22 may be directly fixed by adhesive, welding, or the like.

As shown in FIGS. 2 and 7, the shaft 10 may include a third tube 23 having a lumen extending in the longitudinal direction X. By arranging the first tube 21 and the second tube 22 in the inner cavity of the third tube 23, the third tube 23 wraps around the first tube 21 and the second tube 22, and the first tube 21 and the second tube 22 The tube 22 can be fixed. It is preferable that the third tube 23 is a heat shrink tube. The third tube 23 preferably contains a fluororesin and/or a polyvinyl chloride resin, and more preferably consists of a fluororesin and/or a polyvinyl chloride resin.

The first tube 21 and the second tube 22 each preferably contain resin, and are more preferably made of resin. Preferred resins include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluororesins, polyvinyl chloride resins, aromatic polyetherketone resins, polyether polyamide resins, polyester elastomers, polyimide resins, or mixtures thereof. These may be used alone or in combination of two or more.

The first tube 21 and the second tube 22 may each have an inner layer and an outer layer. Preferably, the outer layer comprises a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, a fluororesin, or a mixture thereof. The inner layer preferably contains a fluororesin, a polyolefin resin such as high-density polyethylene, or a mixture thereof.

The first tube 21 and the second tube 22 may each include a braided body. The braided body is preferably formed by knitting linear bodies into a tubular shape. The braided body preferably contains metal, resin, or both, more preferably contains metal, and still more preferably consists of metal. Examples of the metal include stainless steel such as SUS304 and SUS316, spring steel, Co--Cr alloy, Ni--Ti alloy, and the like. Further, the braided body may include piano wire, oil tempered wire, or the like.

As shown in FIG. 8, the shaft 10 does not necessarily have to have a first tube 21 and a second tube 22, but can be an elongated body having a first lumen 11 and a second lumen 12. It's okay. Examples of the shape of the elongated body include a columnar shape, an elliptical columnar shape, a polygonal columnar shape, and a rounded polygonal columnar shape. The elongated body preferably contains the resin mentioned in the description of the first tube 21 and the second tube 22, and more preferably consists of the resin.

Preferably, the shaft 10 does not have a balloon. Thereby, the diameter of the shaft 10 can be reduced, and the shaft 10 can be easily inserted into the varicose veins 91. Further, the shaft 10 may have a lumen extending in the longitudinal direction X other than the first lumen 11 and the second lumen 12.

The maximum outer diameter of the shaft 10 is preferably 1 mm or more and 12 mm or less, more preferably 3 mm or more and 8 mm or less. This makes it easier to insert the shaft 10 into the varicose veins of the lower limbs. The maximum diameter of the first inner cavity 11 is preferably 0.5 mm or more and 5.0 mm or less, more preferably 1.0 mm or more and 4.0 mm or less. On the other hand, the maximum diameter of the second inner cavity 12 is preferably 0.4 mm or more and 4.0 mm or less, more preferably 0.8 mm or more and 3.5 mm or less. Further, the maximum diameter of the second lumen 12 is preferably smaller than the maximum diameter of the first lumen 11.

The shaft 10 may have a coaxial structure that is a multi-tube structure, but as shown in FIG. It is preferable. The multi-lumen structure allows the space of the first lumen 11 to be enlarged, making it easier to aspirate venous blood 92. Further, it is preferable that the first lumen 11 and the second lumen 12 do not communicate with each other. Thereby, suction through the first lumen 11 and insertion of the cooling member 3 into the second lumen 12 can be facilitated.

As shown in FIG. 1, the varicose vein cooling catheter 1 preferably has a handle member 30 at its proximal end. The handle member 30 preferably has a lumen 31 in which the first tube 21 is embedded and communicates with the lumen of the first tube 21 . By directly or indirectly connecting a suction device 2, which will be described later, to the lumen 31, negative pressure can be applied to the lumen of the first tube 21 and venous blood 92 can be suctioned. The shape of the inner cavity 31 is preferably tapered. Further, the handle member 30 preferably has a lumen 32 in which the second tube 22 is embedded and communicates with the lumen of the second tube 22. Thereby, the cooling member 3 can be inserted from the inner cavity 32 toward the inner cavity of the second tube 22 . The shape of the inner cavity 32 is preferably tapered. The handle member 30 preferably contains resin, and is preferably made of resin.

Hereinafter, a device for cooling varicose veins according to an embodiment will be described with reference to FIGS. 9 to 16. FIG. 9 is a side view of a device for cooling varicose veins according to an embodiment. FIG. 10 is a schematic diagram of a cooling member, a temperature control member, etc., and FIG. 11 is a sectional view of the cooling member. 12 shows a DD cross section in FIG. 10, and FIG. 13 shows a modification of the DD cross section in FIG. 14 and 15 are side views of a modification of the distal end of the cooling member of FIG. 10. FIG. 16 is a schematic diagram of a cooling member, a heating member, a temperature sensor, a temperature indicator, a temperature control member, etc.

As shown in FIG. 9, the varicose vein cooling device 100 according to the embodiment includes a catheter 99 having a shaft 10 extending in the longitudinal direction X, and a cooling member 3. It has a first lumen 11 that extends and sucks venous blood 92 by negative pressure. Using the varicose vein cooling device 100, the varicose veins 91 can be contracted by suctioning the venous blood 92 from the first lumen 11, and the cooling member 3 is further inserted into the varicose veins 91, and the cooling member By cooling the varicose veins 91 that have contracted in step 3, the shape of the varicose veins 91 can be maintained in a contracted state. Varicose veins 91 can be treated by such easy operations.

As shown in FIG. 9, the catheter 99 included in the varicose vein cooling device 100 only needs to have a first lumen 11 for sucking venous blood 92, and a separate lumen for inserting the cooling member 3. It is not necessary to have it. This allows the diameter of the catheter 99 to be reduced. In this case, for example, the cooling member 3 is inserted into the first lumen 11 to expose the distal end 3b of the cooling member 3, and then the venous blood 92 is sucked from the first lumen 11, and the cooling member 3 is The varicose veins 91 may be cooled by the distal end 3b. Alternatively, the cooling member 3 is separately inserted into the varicose vein 91 without inserting the cooling member 3 into the first lumen 11, and the venous blood 92 is suctioned from the first lumen 11. 3b may cool the varicose veins 91.

As shown in FIGS. 9, 10, and 11, the cooling member 3 is preferably elongated. This allows easy insertion into the varicose vein 91. Examples of the shape of the cooling member 3 include a columnar shape, an elliptical columnar shape, a polygonal columnar shape, and a rounded polygonal columnar shape.

It is preferable that the cooling member 3 is configured so that the temperature of the cooling section 3c is reduced by supplying fluid into the cooling section 3c. The fluid includes a liquid or a mixture of a liquid and a gas. The liquid is preferably liquefied nitrogen, liquefied nitrous oxide, liquefied carbon dioxide, liquefied fluorocarbon, or a mixture thereof. Preferred gases are nitrogen, liquefied nitrous oxide, carbon dioxide, fluorocarbons, or mixtures thereof.

The liquid may be a room-temperature liquid produced by applying pressure to a gas, or it may be a low-temperature liquid produced by cooling a gas and applying pressure as necessary. By supplying the liquid produced under pressure to the cooling part 3c of the cooling member 3 and expanding it in the cooling part 3c, the temperature of the cooling part 3c can be lowered. Furthermore, the temperature of the cooling section 3c of the cooling member 3 can also be lowered by supplying low-temperature fluid to the cooling section 3c of the cooling member 3.

It is preferable that the cooling unit 3c is configured not to expand after fluid is supplied into the cooling unit 3c. This improves operability during cooling. Further, it is preferable that the cooling member 3 does not have an expansion portion that expands when fluid is supplied thereinto. A balloon may be mentioned as the expansion part. On the other hand, as the cooling member 3, a balloon catheter for cooling varicose veins, which will be described later, may be used. Using a cooling balloon makes it easier to uniformly cool the inside of the varicose veins 91. Especially when the varicose veins 91 are large, it is effective to use a cooling balloon.

As shown in FIG. 11, the cooling member 3 preferably has a narrow diameter portion 3x, a tapered portion 3y, and a large diameter portion 3z in this order from the distal side to the proximal side. By having a small diameter like the small diameter portion 3x, it is possible to easily insert the cooling member 3 into the varicose vein 91. Further, by having a large diameter like the large diameter portion 3z, the cooling member 3 can be easily operated. Further, the tapered portion 3y is a connecting portion between the narrow diameter portion 3x and the large diameter portion 3z, and by being tapered, the movement of the narrow diameter portion 3x can be easily controlled.

As shown in FIG. 11, the cooling member 3 may include an outer tube 3g, a middle tube 3f disposed in the inner cavity of the outer tube 3g, and an inner tube 3e disposed in the inner cavity of the middle tube 3f. preferable. It is preferable that the cooling member 3 further includes a tip member 3h having a lumen communicating with the lumen of the middle tube 3f and the lumen of the inner tube 3e.

It is preferable that the inner tube 3e has a fluid supply lumen 3i that supplies fluid to the distal end lumen 3l of the distal end member 3h. By passing the fluid through the inner tube 3e located near the central axis of the cooling member 3, it is easy to prevent the temperature of the outer surface of the cooling member 3 other than the cooling part 3c from decreasing when the fluid is at a low temperature. I can do it.

In a cross section perpendicular to the extending direction of the cooling member 3 at the distal end of the inner tube 3e, the area of the tip lumen 3l is preferably larger than the area of the fluid supply lumen 3i of the inner tube 3e. As a result, the volume of the fluid expands and the pressure decreases, making it easier to lower the temperature of the distal end cavity 3l. The area of the tip lumen 3l is preferably 5 times or more, more preferably 8 times or more, the area of the fluid supply lumen 3i. This makes it easier to expand the fluid. On the other hand, the magnification is preferably 20 times or less, more preferably 15 times or less. Thereby, the outer diameter of the cooling part 3c can be reduced.

The proximal end of the inner tube 3e is preferably connected directly or indirectly to the fluid reservoir 5. The proximal end of the inner tube 3e is connected to the fluid reservoir 5 via a tube 8a, for example, so that fluid can be supplied from the fluid reservoir 5 to the inner tube 3e via the tube 8a. The fluid storage device 5 may be any device that can store fluid. Preferably, the walls constituting the fluid reservoir 5 include a metal layer, a heat insulation layer, and a vacuum layer.

Preferably, the fluid storage device 5 and/or the tube 8a has a regulator 6 that can adjust the flow rate and pressure of the fluid. Examples of the regulator 6 include a cock, a valve, and the like. The regulator 6 may have an operating mechanism capable of operating a cock or valve based on a signal from a temperature control member 4 or the like, which will be described later.

It is preferable that the middle tube 3f has a fluid discharge lumen 3k that discharges fluid from the distal end lumen 3l of the distal end member 3h. Thereby, damage to the cooling portion 3c of the cooling member 3 due to volumetric expansion of the fluid can be easily avoided.

It is preferable that the middle pipe 3f is connected to the fluid discharge pump 7, for example, via a tube 8b. Thereby, the fluid in the middle pipe 3f can be discharged to the outside of the cooling member 3. The fluid discharge pump 7 may be operated based on a signal from a temperature control member 4, etc., which will be described later.

It is preferable that the outer tube 3g has a vacuum lumen 3j. The vacuum lumen 3j only needs to function as a heat insulator, and the vacuum lumen 3j can easily prevent the temperature of the cooling member 3 other than the cooling portion 3c from decreasing. The cooling member 3 having such a vacuum lumen 3j is particularly suitable when using a low-temperature fluid.

The outer tube 3g may be connected to the fluid discharge pump 7, for example, via a tube 8b. Thereby, the pressure inside the outer tube 3g can be reduced to a vacuum state. On the other hand, the vacuum lumen 3j may be a closed vacuum space surrounded by the outer tube 3g, the tip member 3h, and other members.

The inner tube 3e, the middle tube 3f, and the outer tube 3g each preferably contain resin and/or metal, and are preferably made of resin or metal. Examples of the resin include fluororesin, epoxy resin, and silicone. Examples of the metal include stainless steel.

The tip member 3h preferably contains metal, and more preferably consists of metal. Preferably, the metal is aluminum, copper, silver, gold, or an alloy thereof. These metals are preferable because the temperature easily decreases.

The thickness of the inner tube 3e, middle tube 3f, and outer tube 3g is preferably 0.01 mm or more and 0.20 mm or less, and more preferably 0.05 mm or more and 0.15 mm or less.

The outer diameter of the outer tube 3g in the narrow diameter portion 3x is preferably 0.5 mm or more and 5.0 mm or less, more preferably 2.5 mm or more and 4.0 mm or less. The outer diameter of the outer tube 3g in the large diameter portion 3z is preferably 10 mm or more and 50 mm or less, more preferably 20 mm or more and 35 mm or less.

The inner diameter of the inner tube 3e is preferably 0.15 times or more and 0.35 times or less, more preferably 0.20 times or more and 0.32 times or less, than the outer diameter of the outer tube 3g. The inner diameter of the inner tube 3f is preferably 0.40 times or more and 0.60 times or less, more preferably 0.45 times or more and 0.55 times or less, than the outer diameter of the outer tube 3g. The inner diameter of the outer tube 3g is preferably 0.90 times or more and 0.99 times or less, more preferably 0.91 times or more and 0.98 times or less, the outer diameter of the outer tube 3g.

The length of the narrow diameter portion 3x in the extending direction of the cooling member 3 is preferably 100 mm or more and 300 mm or less, more preferably 150 mm or more and 250 mm or less.

As shown in FIG. 14, a distal end 3t may be disposed at the distal end 3b of the cooling member 3. The shape of the tip 3t is preferably a cylinder, an elliptical cylinder, a polygonal cylinder, a rounded polygonal cylinder, or a combination thereof, and more preferably a cylinder, an elliptical cylinder, or a rounded polygonal cylinder. Thereby, the cooling member 3 can be easily inserted into the body. It is preferable that the distal tip 3t has a lumen, and it is preferable that at least a part of the distal end 3b of the cooling member 3 is disposed in the lumen. The distal tip 3t may have a curved portion, as shown in FIG. 15. Thereby, it is possible to facilitate insertion into a portion that requires rotational movement during insertion.

The tip 3t preferably contains an elastomer, rubber, or a mixture thereof, and more preferably consists of an elastomer, rubber, or a mixture thereof. Thereby, it is possible to easily prevent the distal end portion 3b of the cooling member 3 from being stuck when inserted into the body. Elastomers include polyamide elastomers, polyolefin elastomers, polyurethane elastomers, or mixtures thereof. Rubbers include silicone rubber, latex rubber, or mixtures thereof.

Although not shown, a pressure-sensitive sensor may be disposed at the distal end of the cooling member 3. Preferably, the information measured by the pressure sensor is transmitted by wire or wirelessly to a pressure indicator placed outside the body. By operating the cooling member 3 while checking the pressure value displayed on the pressure display, the user can easily prevent piercing when the cooling member 3 is inserted into the body. Preferably, the pressure indicator has a liquid crystal display. Further, a temperature sensor, which will be described later, may be disposed at the distal end portion 3b of the cooling member 3.

As shown in FIG. 10, the varicose vein cooling device 100 preferably has a temperature control member 4 that is connected to the cooling member 3 and controls the temperature of the cooling section 3c of the cooling member 3. Furthermore, the device 100 for cooling varicose veins preferably comprises a regulator 6 and a pump 7 for fluid evacuation.

Preferably, the temperature control member 4 transmits a signal to the regulator 6 to operate the regulator 6 to adjust the flow rate, pressure, etc. of the fluid. By adjusting the flow rate, pressure, etc. of the fluid in this way, the temperature of the cooling section 3c can be controlled. Preferably, the temperature control member 4 transmits a signal to the fluid discharge pump 7 to operate the fluid discharge pump 7 to adjust the amount of fluid discharged, the discharge speed, and the like. In this way, the temperature of the cooling section 3c can also be controlled by adjusting the amount of fluid discharged, the discharge speed, etc. Signals can be transmitted from the temperature control member 4 to the regulator 6 and the fluid discharge pump 7 via

communication lines

9a, 9b, etc., or may be transmitted by wireless communication. Examples of the

communication lines

9a and 9b include electric wires and optical fiber cables. Furthermore, in the case of wireless communication, Bluetooth (registered trademark), Wi-Fi, etc. may be used.

It is preferable that the temperature control member 4 has an input section, a memory, a processor, and an output section. Preferably, the memory stores the instructions. The processor is capable of executing the instructions stored in the memory according to the signals from the input and transmitting the signals from the output to the regulator 6 and/or the fluid evacuation pump 7 to actuate each member. . An example of the processor is a CPU. Examples of memory include ROM, RAM, and flash memory. The input unit may be a touch panel, an input button, an input dial, or the like. The output section may be anything that can transmit a signal to an electric wire, optical fiber cable, or the like. Further, the output section may be a wireless signal transmitter.

As shown in FIG. 16, the varicose vein cooling device 100 may include a heating member 40. Preferably, heating member 40 is placed outside the body. By heating the vicinity of the varicose veins from outside the body using the heating member 40, damage to the surrounding tissues of the varicose veins due to excessive cooling of the cooling member 3 can be easily avoided. In this case, examples of the heating member 40 include a fan-type heater that heats by emitting hot air, an infrared-type heater that emits infrared rays, and a radiation-type heater that heats by generating heat without emitting air. Among these, a radiation type heater is preferable. The radiation type heater is preferably a sheet-shaped heater. Examples of sheet-shaped heaters include rubber heaters, film heaters, and the like.

As shown in FIG. 16, the varicose vein cooling device 100 may include a temperature sensor 41. For example, the cooling member 3 may have a temperature sensor 41 inside. Examples of the temperature sensor 41 include a thermocouple, a resistance temperature detector, a bimetal thermometer, a radiation thermometer, a thermistor thermometer, and the like. Preferably, the temperature sensor 41 is provided within the tip lumen 3l. In FIG. 16, a thermocouple is disposed within the cooling member 3 as the temperature sensor 41, and a temperature measuring junction 41p of the thermocouple is disposed at the distal end of the cooling member 3. Moreover, the temperature sensor 41 may be arranged on the distal tip 3t mentioned above. Further, the temperature sensor 41 does not need to be placed on the cooling member 3, and may be placed on the surface of the skin. The information acquired by the temperature sensor 41 is preferably transmitted to the temperature control member 4 by wire or wirelessly. Based on this information, the temperature control member 4 may transmit a signal to the regulator 6 and/or the pump 7 for fluid evacuation. For example, when the temperature detected by the temperature sensor 41 falls below a certain temperature, the temperature control member 4 transmits a signal to the regulator 6 and/or the fluid discharge pump 7 to reduce the flow rate of the fluid or It may be configured to stop the supply. This makes it easier to avoid damage to the surrounding tissues of the varicose veins due to an excessive drop in temperature. The signal from the temperature sensor 41 may be transmitted to the temperature control member 4 by wire or wirelessly.

The temperature control member 4 may be configured to transmit a signal to the heating member 40 to heat it when the temperature detected by the temperature sensor 41 falls below a certain temperature. This makes it easier to avoid damage to the surrounding tissues of varicose veins due to excessive cooling of the cooling member 3. The signal from the temperature control member 4 may be transmitted to the heating member 40 by wire or wirelessly.

As shown in FIG. 16, the varicose vein cooling device 100 may include a temperature indicator 42. Preferably, temperature indicator 42 is placed outside the body. For example, the information acquired by the temperature sensor 41 may be transmitted by wire or wirelessly to the temperature display 42 placed outside the body. The user may reduce the fluid flow rate or stop the fluid supply by checking the temperature displayed on the temperature display 42 and directly operating the regulator 6 and/or the fluid discharge pump 7. However, by directly operating the heating member 40, the temperature of the tissue surrounding the varicose veins may be increased from the skin. Preferably, temperature indicator 42 has a liquid crystal display.

These heating member 40, temperature sensor 41, and/or temperature indicator 42 may be configured to be controlled by the temperature control member 4 described above, or may be configured to be controlled by another control member. may have been done. The signal related to the control may be transmitted by wire or by wireless communication. Note that these members do not necessarily need to be separated, and two or more may be configured integrally.

As shown in FIG. 12, in a cross section perpendicular to the extending direction of the cooling member 3, the outer edge of the distal end portion 3b of the cooling member 3 may be circular, but as shown in FIG. A rounded rectangle or a rectangle is preferred, an ellipse or a rounded rectangle is more preferred, and an ellipse is even more preferred. That is, since the distal end portion 3b of the cooling member 3 has the flattened portion 3d, it is possible to easily treat varicose veins. Specifically, when the venous blood 92 is sucked, the varicose veins 91 do not remain approximately circular but deform into a flat shape and contract. The distal end portion 3b and the inner wall of the varicose vein 91 come into contact easily. Furthermore, this makes it easier to reduce the volume of varicose veins 91 when venous blood 92 is suctioned.

The catheter included in the varicose vein cooling device 100 is the varicose vein cooling catheter 1 described above, and the cooling member 3 is preferably inserted into the second lumen 12. For details of each part, refer to the description of the varicose vein cooling catheter 1.

As shown in FIG. 9, it is preferable that the suction device 2 is connected directly or indirectly to the proximal end 11A of the first lumen 11. This allows negative pressure to be applied to the first lumen 11. Examples of the suction device 2 include a suction mechanism including a pump and a waste liquid storage container, a syringe, and the like. In FIG. 9, the suction device 2 is indirectly connected to the proximal end 11A of the first lumen 11 via the tube 2a. Although not shown, a valve may be disposed at the proximal end 11A of the first lumen 11. Preferably, the valve has a slit. The tube 2a of the suction device 2 can be inserted through the slit. Furthermore, the cooling member 3 may be inserted through the slit. Further, the valve may have a plurality of slits, and for example, the plurality of slits may intersect to form a cross shape. Preferably, the valve contains resin, more preferably rubber. Such a valve can facilitate suction from the tube 2a.

Below, a method for cooling varicose veins according to an embodiment of the first invention of the present application will be described. As shown in FIG. 3, the method for cooling varicose veins according to the embodiment of the first invention of the present application includes the step of inserting a cooling member 3 into a vein 90 and cooling the varicose veins 91 that the vein 90 has. . The varicose veins 91 are a part of the varicose veins 90, and it is preferable to insert the cooling member 3 into the varicose veins 91 from a normal part of the vein 90 other than the varicose veins 91. May be inserted.

When cooling the varicose veins 91, it is preferable to freeze at least a portion of the varicose veins 91. This makes it easier to harden the varicose veins 91.

It is preferable to arrange the cooling part 3c of the cooling member 3 at the distal part of the varicose vein 91, and cool the entire varicose vein 91 while moving the cooling part 3c from the distal part to the proximal part of the varicose vein 91. . Since the cooled portion of the varicose veins 91 hardens, it is easier to move the cooling member 3 by cooling the cooling portion 3c while moving it backward rather than by moving it forward. Note that the proximal part of the varicose vein 91 is the side of the varicose vein 91 that is far from the heart, and the distal part of the varicose vein 91 is the side of the varicose vein 91 that is close to the heart.

As shown in FIG. 4, the method for cooling varicose veins according to the embodiment preferably further includes a step of sucking venous blood 92 within varicose veins 91. This allows the varicose veins 91 to contract. The suction is preferably performed after the cooling part 3c of the cooling member 3 is placed inside the varicose vein 91. Thereby, the inner wall of the varicose vein 91 and the cooling part 3c can be made to easily come into contact with each other. Further, it is preferable to move the cooling unit 3c from the distal side to the proximal side of the varicose vein 91 while performing the suction.

After the suction, it is preferable to lower the temperature of the cooling part 3c of the cooling member 3 for cooling. The amount of venous blood 92 in the varicose veins 91 can be reduced by suction, and as a result, the varicose veins 91 can be easily cooled by the cooling unit 3c.

Although not shown, it is preferable that the method for cooling varicose veins according to the embodiment further includes a step of heating the skin with a heating member. For example, by heating the skin near the varicose veins 91 from outside the body with a heating member, damage to the tissues surrounding the varicose veins 91 due to excessive cooling of the cooling member 3 can be easily avoided. Therefore, it is preferable that the heating is performed after cooling by the cooling section 3c, but heating may be performed before cooling.

In the varicose vein cooling method according to the embodiment, it is preferable to use the varicose vein cooling catheter 1 and/or the varicose vein cooling device 100 described above. For details, refer to the descriptions of the varicose vein cooling catheter 1 and the varicose vein cooling device 100.

A balloon catheter for cooling varicose veins according to an embodiment of the second invention of the present application is a balloon catheter having a shaft extending in the longitudinal direction and a balloon provided at a distal portion of the shaft. The balloon has a fluid supply lumen that extends in the longitudinal direction and supplies fluid to the balloon, and a fluid discharge lumen that extends in the longitudinal direction and discharges fluid from the balloon. It has a cooling fluid inside.

By expanding the balloon of the balloon catheter within the varicose veins and cooling the varicose veins from within, the cells on the inner wall of the varicose veins can be necrotized and the varicose veins can finally regress. According to such cooling, an inflammatory reaction is less likely to occur than when treating varicose veins by using a hardening agent or by ablation, so that side effects associated with the treatment can be reduced. Furthermore, since pain during treatment can be reduced by cooling, anesthesia can be omitted or the amount of anesthesia can be reduced, and side effects caused by anesthesia can also be avoided or reduced.

Hereinafter, a balloon catheter for cooling varicose veins according to an embodiment will be described with reference to FIGS. 17 to 20 and 33. FIG. 17 is a side view of the balloon catheter for cooling varicose veins according to the embodiment. FIG. 18 is a sectional view taken along the line XX in FIG. 17, and FIG. 19 is a sectional view showing a modification thereof. FIG. 20 is a schematic diagram of the varicose vein cooling balloon catheter according to the embodiment of FIG. 17 and its peripheral equipment. FIG. 33 is a side view showing the distal portion of a modified example of the varicose vein cooling balloon catheter of FIG. 17.

As shown in FIGS. 17 and 18, the varicose vein cooling balloon catheter 202 includes a shaft 204 extending in the longitudinal direction D, and a balloon 207 provided at a distal portion 204b of the shaft 204. Further, the shaft 204 has a fluid supply lumen 204C extending in the longitudinal direction D and supplying fluid to the balloon 207, and a fluid discharge lumen 204D extending in the longitudinal direction D and discharging fluid from the balloon 207. have. Balloon 207 has cooling fluid inside.

In this specification, the proximal side of the shaft 204 of the variceal cooling balloon catheter 202 means the user's proximal side in the extending direction of the shaft 204, and the distal side of the shaft 204 means the side near the user's hand in the extending direction of the shaft 204. The proximal side in the direction of extension means the opposite side. Further, the direction in which the shaft 204 extends is referred to as a longitudinal direction D.

It is preferable that the fluid supply lumen 204C and the lumen 207C of the balloon 207 communicate with each other. Thereby, fluid can be supplied from the fluid supply lumen 204C to the lumen 207C, and the balloon 207 can be expanded.

Any fluid may be used as long as it is supplied into the balloon 207 and inflates the balloon 207. Preferably, the fluid expands in volume and decreases in temperature after being supplied to the lumen 207C of the balloon 207. This allows the surface temperature of the balloon 207 to be lowered while expanding the balloon 207. The fluid is preferably a liquid or a mixture of liquid and gas. The liquid is preferably liquefied nitrogen, liquefied nitrous oxide, liquefied carbon dioxide, liquefied fluorocarbon, or a mixture thereof, and more preferably liquefied carbon dioxide. The gas is preferably nitrogen, liquefied nitrous oxide, carbon dioxide, fluorocarbon, or a mixture thereof, and more preferably carbon dioxide. The liquid may be a room-temperature liquid produced by applying pressure to a gas, or a low-temperature liquid produced by cooling a gas and applying pressure as necessary.

The balloon 207 can have inside thereof a fluid whose temperature has been reduced by being supplied to the lumen 207C, that is, a cooling fluid. Specifically, balloon 207 can have cooling fluid in lumen 207C. Balloon 207 preferably has cooling fluid in lumen 207C, at least after inflation. Since the cooling fluid is normally flowing, the balloon 207 only needs to have the flowing cooling fluid therein at least temporarily.

It is preferable that the lumen 207C of the balloon 207 and the fluid discharge lumen 204D communicate with each other. Thereby, the fluid in the lumen 207C can be discharged to the outside from the fluid supply lumen 204C, and it is possible to prevent the balloon 207 from bursting due to excessive expansion.

As shown in FIG. 18, in a cross section perpendicular to the longitudinal direction D, the cross-sectional area of the fluid supply lumen 204C is preferably smaller than the cross-sectional area of the fluid discharge lumen 204D. Since the cross-sectional area of the fluid supply lumen 204C is relatively small as described above, it is possible to improve the volume increase rate of the fluid when the fluid is supplied from the fluid supply lumen 204C to the lumen 207C of the balloon 207. Therefore, the temperature of the surface of the balloon 207 can be easily lowered due to the Joule-Thompson effect. Moreover, since the cross-sectional area of the fluid discharge lumen 204D is relatively large, it is possible to easily avoid bursting of the balloon 207 due to volumetric expansion of the fluid. Further, it is more preferable that the cross-sectional area of the fluid supply lumen 204C is smaller than the cross-sectional area of the fluid discharge lumen 204D over the entire length of the shaft 204.

In a cross section perpendicular to the longitudinal direction D, the cross-sectional area of the fluid supply lumen 204C is preferably 0.8 times or less, and preferably 0.6 times or less, the cross-sectional area of the fluid discharge lumen 204D. More preferably, it is 0.5 times or less. On the other hand, the cross-sectional area of the fluid supply lumen 204C is preferably 0.01 times or more, more preferably 0.05 times or more, the cross-sectional area of the fluid discharge lumen 204D. Note that the cross-sectional area is the total cross-sectional area of the plurality of lumens when there are a plurality of lumens.

The shapes of the cross section of the fluid supply lumen 204C and the cross section of the fluid discharge lumen 204D in a cross section perpendicular to the longitudinal direction D are preferably circular, elliptical, polygonal, or rounded polygonal, respectively. , a circular or oval shape is more preferable. This makes it possible to efficiently supply and discharge fluid. Further, the outer edges of the fluid supply lumen 204C and the fluid discharge lumen 204D in the cross section preferably include a straight line, a curved line, or a straight line and a curved line, and more preferably include a curved line, or a straight line and a curved line. , it is even more preferable to consist of a curved line. Note that the cross-sectional shapes of the fluid supply lumen 204C and the fluid discharge lumen 204D may be the same or different.

The shaft 204 preferably has an outer tube 206 extending in the longitudinal direction D and an inner tube 205 extending in the longitudinal direction D and disposed in the inner lumen of the outer tube 206. Thereby, the lumen between the inner surface of the outer tube 206 and the outer surface of the inner tube 205 can be used as the lumen 204D for fluid discharge. Furthermore, the lumen of the inner tube 205 can be used as the fluid supply lumen 204C.

As shown in FIG. 19, the inner tube 205 may have a plurality of lumens extending in the longitudinal direction D. Two or more of these plurality of lumens may be used as the fluid supply lumen 204C. This makes it easier to lower the surface temperature of the balloon 207 uniformly.

As shown in FIG. 17, in the longitudinal direction D, the distal end 204CB of the fluid supply lumen 204C is preferably located more distally than the distal end 204DB of the fluid discharge lumen 204D. This makes it possible to reduce the amount of fluid that is immediately discharged from the fluid discharge lumen 204D among the fluids supplied to the inside of the balloon 207, so that the balloon 207 can be efficiently cooled.

The distal end 205B of the inner tube 205 is preferably located more distally than the distal end 206B of the outer tube 206. This makes it possible to reduce the amount of fluid that is immediately discharged from the fluid discharge lumen 204D among the fluids supplied to the inside of the balloon 207, so that the balloon 207 can be efficiently cooled. On the other hand, the distal end 205B of the inner tube 205 is preferably located on the proximal side of the distal end 207b of the balloon 207, which will be described later.

The proximal end 207a of the balloon 207 is preferably fixed to the outer surface of the distal end 206b of the outer tube 206. Further, the distal end 207b of the balloon 207 is preferably fixed to the outer surface of the distal tip 207F, but may be fixed to the inner surface of the distal tip 207F. A space surrounded by a non-fixed portion of the balloon 207 that is not fixed to other members can form a lumen 207C. The shape of the tip 207F is preferably a cylinder, an elliptical cylinder, a polygonal cylinder, a rounded polygonal cylinder, or a combination thereof, and more preferably a cylinder, an elliptical cylinder, or a rounded polygonal cylinder. This makes it easier to insert the varicose vein cooling balloon catheter 202. Further, the distal tip 207F may have a curved portion, as shown in FIG. 33. Thereby, it is possible to facilitate insertion into a portion that requires rotational movement during insertion.

The tip 207F preferably contains an elastomer, rubber, or a mixture thereof, and more preferably consists of an elastomer, rubber, or a mixture thereof. This makes it easier to prevent the distal tip 207F from being stuck when inserted into the body. Elastomers include polyamide elastomers, polyolefin elastomers, polyurethane elastomers, or mixtures thereof. Rubbers include silicone rubber, latex rubber, or mixtures thereof.

The number of balloons 207 may be one, or two or more. When the number of balloons 207 is two or more, it is preferable that the plurality of balloons 207 are adjacent to each other in the longitudinal direction D, as shown in FIG. 33. Thereby, the balloon 207 can be expanded and easily brought into contact with the inner wall of the complex-shaped varicose vein. On the other hand, the number of balloons 207 may be 10 or less, or may be 5 or less. This allows manufacturing costs to be reduced.

The inner tube 205, the outer tube 206, and the distal tip 207F each preferably contain resin, and are more preferably made of resin. Preferred resins include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluororesins, polyvinyl chloride resins, aromatic polyetherketone resins, polyether polyamide resins, polyester elastomers, polyimide resins, or mixtures thereof. These may be used alone or in combination of two or more.

The inner tube 205 and the outer tube 206 may each have an inner layer and an outer layer. Preferably, the outer layer comprises a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, a fluororesin, or a mixture thereof. The inner layer preferably contains a fluororesin, a polyolefin resin such as high-density polyethylene, or a mixture thereof. Inner tube 205 and outer tube 206 may each include a braided body. The braided body is preferably formed by knitting linear bodies into a tubular shape. The braided body preferably contains metal, resin, or both, more preferably contains metal, and still more preferably consists of metal. Examples of the metal include stainless steel such as SUS304 and SUS316, spring steel, Co--Cr alloy, Ni--Ti alloy, and the like. Further, the braided body may include piano wire, oil tempered wire, or the like.

The outer surface of the balloon 207 preferably does not have other members such as electrodes. Thereby, the outer surface of the balloon 207 can be brought into direct contact with the varicose veins, and the varicose veins can be efficiently cooled.

As shown in FIG. 17, the balloon 207 includes a first tapered part whose diameter increases from the proximal side to the distal side, a straight tube part, and a second taper part whose diameter decreases from the proximal side to the distal side. It is preferable to have a part. The insertion resistance can be lowered by the first tapered portion. Furthermore, the straight pipe portion makes it easier to uniformly cool varicose veins. Furthermore, the second tapered portion makes it easier to pull back the balloon 207 when recovering it after the treatment.

The balloon 207 preferably contains resin, and is more preferably made of resin. This makes it easier for the balloon 207 to come into contact with the inner wall of the varicose veins, making it possible to efficiently cool the varicose veins. The resin is preferably a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, a vinyl chloride resin, a silicone resin, a natural rubber, or a mixture thereof, and more preferably a polyamide resin, a polyester resin, a polyurethane resin, or a mixture thereof. Further, the resin is preferably one of these elastomer resins. The balloon 207 can be manufactured using resin by biaxial stretch blow molding, dip molding, injection molding, compression molding, or the like.

Shaft 204 preferably has a handle member 208 at proximal end 204a. The handle member 208 may be anything that can be held and operated by the user. Handle member 208 preferably has proximal end 205a of inner tube 205 and proximal end 206a of outer tube 206 embedded therein.

As shown in FIG. 20, the proximal end 205A of the inner tube 205 is preferably connected directly or indirectly to a fluid reservoir 209D. Proximal end 205A of inner tube 205 can be coupled to fluid reservoir 209D via tube 209G, for example, such that fluid can be supplied from fluid reservoir 209D to inner tube 205 via tube 209G. . The fluid storage device 209D may be anything that can store fluid. Preferably, the walls that make up the fluid reservoir 209D include a metal layer, an insulation layer, and a vacuum layer.

Preferably, the fluid storage device 209D and/or the tube 209G has a regulator 209E that can adjust the flow rate and pressure of the fluid. Examples of the regulator 209E include a cock, a valve, and the like. The regulator 209E may have an operating mechanism capable of operating a cock or valve based on a signal from a temperature control member 209C, etc., which will be described later.

The proximal end 206A of the outer tube 206 is preferably connected directly or indirectly to the fluid evacuation pump 209F. The proximal end 206A of the outer tube 206 is preferably connected to a fluid evacuation pump 209F, for example via a tube 209H. This allows the fluid in the outer tube 206 to be drained to the outside. The fluid discharge pump 209F may be operated based on a signal from a temperature control member 209C, etc., which will be described later.

It is preferable that the temperature control member 209C transmits a signal to the regulator 209E to operate the regulator 209E to adjust the flow rate, pressure, etc. of the fluid. The temperature of the balloon 207 can be controlled by adjusting the fluid flow rate, pressure, etc. in this way. Further, it is preferable that the temperature control member 209C transmits a signal to the fluid discharge pump 209F to operate the fluid discharge pump 209F to adjust the discharge amount, discharge speed, etc. of the fluid. The temperature of the balloon 207 can also be controlled by adjusting the fluid discharge amount, discharge speed, etc. in this way. Signals can be transmitted from the temperature control member 209C to the regulator 209E and the fluid discharge pump 209F via communication lines 209I, 209J, etc., or may be transmitted by wireless communication. Examples of the communication lines 209I and 209J include electric wires and optical fiber cables. Furthermore, in the case of wireless communication, Bluetooth (registered trademark), Wi-Fi, etc. may be used.

It is preferable that the temperature control member 209C has an input section, a memory, a processor, and an output section. Preferably, the memory stores the instructions. The processor can execute instructions stored in memory according to signals from the input and transmit signals from the output to regulator 209E and/or fluid evacuation pump 209F to actuate each member. . An example of the processor is a CPU. Examples of memory include ROM, RAM, and flash memory. The input unit may be a touch panel, an input button, an input dial, or the like. The output section may be anything that can transmit a signal to an electric wire, optical fiber cable, or the like. Further, the output section may be a wireless signal transmitter.

Although not shown, the varicose vein cooling balloon catheter 202 may have a temperature sensor inside the balloon 207. Preferably, the temperature sensor is secured to inner tube 205 within lumen 207C. The information acquired by the temperature sensor is preferably transmitted to the temperature control member 209C by wire or wirelessly. Based on this information, temperature control member 209C may communicate a signal to regulator 209E and/or fluid evacuation pump 209F.

It is preferable that the balloon catheter 202 does not have a linear body for controlling the direction of movement on the outer surface of the distal portion. A complicated operation in the advancing direction is not necessary inside the varicose vein, and this configuration allows the balloon catheter 202 to be easily moved within the first lumen 211 of the catheter 201, which will be described later.

Hereinafter, a balloon catheter for cooling varicose veins according to another embodiment will be described with reference to FIGS. 21 and 22. FIG. 21 is a side view of a balloon catheter for cooling varicose veins according to another embodiment. FIG. 22 is a sectional view showing the YY cross section of FIG. 21.

As shown in FIGS. 21 and 22, the varicose vein cooling balloon catheter 203 has a shaft 204 extending in the longitudinal direction D, and a balloon 207 provided at a distal portion 204b of the shaft 204. Further, the shaft 204 has a fluid supply lumen 204C extending in the longitudinal direction D and supplying fluid to the balloon 207, and a fluid discharge lumen 204D extending in the longitudinal direction D and discharging fluid from the balloon 207. have. Additionally, balloon 207 has cooling fluid inside.

It is preferable that the shaft 204 has a cooling part 205K inside the balloon 207 that cools the fluid. Since the cooling unit 205K inside the balloon 207 can cool the fluid supplied to the balloon 207, it is possible to use a fluid whose temperature does not easily decrease due to volumetric expansion. The fluid is preferably a liquid, and examples of the liquid include water, an aqueous sodium chloride solution, and the like. Preferably, the liquid includes a freezing point hardening agent that lowers the freezing point of the liquid. Examples of the freezing point hardening agent include calcium chloride, ethanol, propylene glycol, ethylene glycol, propanone, butanone, ammonia, and the like. The liquid may also contain other additives such as contrast agents. The cooling unit 205K can be configured, for example, by a tip member 205L of a cooling tube 205F, which will be described later.

The balloon 207 can have inside thereof a fluid that is supplied to the inner cavity 207C and cooled by the cooling unit 205K, that is, a cooling fluid. Specifically, balloon 207 can have cooling fluid in lumen 207C. Balloon 207 preferably has cooling fluid in lumen 207C, at least after inflation. Since the cooling fluid is normally flowing, the balloon 207 only needs to have the flowing cooling fluid therein at least temporarily.

It is preferable that the lumen 207C of the balloon 207 and the fluid discharge lumen 204D communicate with each other. Thereby, the fluid in the lumen 207C can be discharged to the outside from the fluid supply lumen 204C. Furthermore, such discharge makes it easier for the cooling fluid in the inner cavity 207C of the balloon 207 to flow, making it easier to lower the temperature of the balloon 207 as a whole, and also causing the fluid to freeze when the fluid is a liquid. can be easily prevented.

As shown in FIG. 21, the shaft 204 has an outer tube 206 extending in the longitudinal direction D, and an inner tube 205 extending in the longitudinal direction D and disposed in the inner lumen of the outer tube 206. is preferred.

As shown in FIG. 22, the shaft 204 preferably has a plurality of inner tubes 205. For example, it is more preferable that the shaft 204 has, as the inner tube 205, a fluid supply tube 205C having a fluid supply lumen 204C and a fluid discharge tube 205D having a fluid discharge lumen 204D. Such a multi-lumen structure makes it easy to increase the amount of fluid supplied and the amount of fluid discharged. Furthermore, it is more preferable that the shaft 204 has a cooling tube 205F extending in the longitudinal direction D as the inner tube 205. The temperature of the fluid supplied into the balloon 207 can be lowered by the cooling part 205K of the cooling pipe 205F.

It is preferable that the cooling tube 205F has an outer tube 205H and an inner tube 205G disposed in the inner cavity of the outer tube 205H. Thereby, the inner cavity of the inner pipe 205G can be used as the refrigerant supply cavity 205I, and the inner cavity between the inner surface of the outer pipe 205H and the outer surface of the inner pipe 205G can be used as the refrigerant discharge cavity 205J.

It is preferable that the cooling tube 205F has a tip member 205L at its distal end, which has a lumen that communicates with the lumen of the inner tube 205G and the inner lumen of the outer tube 205H. The inner cavity of the tip member 205L is preferably configured so that the refrigerant supplied from the refrigerant supply cavity 205I can expand in volume. Due to the volumetric expansion of the refrigerant within the tip member 205L, the temperature decreases, allowing the tip member 205L to function as the cooling section 205K. Note that the cooling pipe 205F is preferably configured so that the coolant does not leak into the inner cavity 207C of the balloon 207.

The refrigerant is preferably a liquid or a mixture of liquid and gas. The liquid is preferably liquefied nitrogen, liquefied nitrous oxide, liquefied carbon dioxide, liquefied fluorocarbon, or a mixture thereof, and more preferably liquefied nitrogen. The gas is preferably nitrogen, liquefied nitrous oxide, carbon dioxide, fluorocarbon, or a mixture thereof, with nitrogen being preferred. The liquid may be a room-temperature liquid produced by applying pressure to a gas, or a low-temperature liquid produced by cooling a gas and applying pressure as necessary.

In a cross section perpendicular to the longitudinal direction D at the distal end of the inner tube 205G, the area of the lumen of the tip member 205L is preferably larger than the area of the coolant supply cavity 205I of the inner tube 205G. As a result, the volume of the fluid expands and the pressure decreases, making it easier to lower the temperature of the tip member 205L. The area of the tip member 205L is preferably 5 times or more, more preferably 8 times or more, the area of the coolant supply cavity 205I. This makes it easier to expand the fluid. On the other hand, the magnification is preferably 20 times or less, more preferably 15 times or less. Thereby, the outer diameter of the tip member 205L can be reduced.

The cooling tube 205F may have a middle tube between the outer tube 205H and the inner tube 205G. For example, by closing the lumen between the outer tube 205H and the middle tube in a vacuum state, the vacuum layer can function as a heat insulating layer.

The proximal end of the inner tube 205G is preferably connected directly or indirectly to a fluid reservoir. The proximal end of the inner tube 205G is connected to a fluid reservoir via a tube, for example, so that fluid can be supplied from the fluid reservoir to the inner tube 205G via the tube. The fluid reservoir and/or tube may have a regulator that allows the fluid flow rate, pressure to be adjusted. For details of the temperature control member, fluid storage device, regulator, etc., refer to the description of the temperature control member 209C, fluid storage device 209D, and regulator 209E connected to the varicose vein cooling balloon catheter 202 described above.

It is preferable that the outer tube 205H is connected to a fluid discharge pump, for example, via a tube. Thereby, the fluid in the outer tube 205H can be discharged to the outside of the cooling tube 205F. The fluid discharge pump may be operated based on a signal from a temperature control member or the like. For details of the fluid discharge pump, temperature control member, etc., refer to the description of the fluid discharge pump 209F and temperature control member 209C connected to the varicose vein cooling balloon catheter 202 described above.

Furthermore, it is preferable that the shaft 204 has an elongated body 205E in the inner cavity of the outer tube 206. This makes it easier to prevent the shaft 204 from kinking. The shape of the elongated body 205E is preferably a columnar shape, an elliptical columnar shape, a polygonal columnar shape, a rounded polygonal columnar shape, or a combination thereof, and a columnar shape, an elliptical columnar shape, or a rounded polygonal columnar shape is more preferable. Further, it is preferable that the distal end of the elongated body 205E be located further distally than the distal end of the balloon 207. The elongated body 205E preferably contains resin and/or metal, and is preferably made of resin or metal. Preferred resins include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluororesins, polyvinyl chloride resins, aromatic polyetherketone resins, polyether polyamide resins, polyester elastomers, polyimide resins, or mixtures thereof. These may be used alone or in combination of two or more. The metal is preferably stainless steel such as SUS304 or SUS316, spring steel, Co--Cr alloy, Ni--Ti alloy, or a mixture thereof.

Although not shown, a pressure-sensitive sensor may be disposed at the distal end of the elongate body 205E. Preferably, the information measured by the pressure sensor is transmitted by wire or wirelessly to a pressure indicator placed outside the body. By operating the elongated body 205E while checking the pressure value displayed on the pressure display, the user can easily prevent the elongated body 205E from being stabbed when inserted into the body. Preferably, the pressure indicator has a liquid crystal display. Further, a temperature sensor may be disposed at the distal end portion 205Eb of the elongated body 205E. Further, the above-mentioned distal tip 207F may be arranged at the distal end portion 205Eb of the elongated body 205E. In this case, it is preferable that at least a portion of the distal end 205Eb of the elongated body 205E is disposed in the inner cavity of the distal tip 207F.

The tubes constituting the cooling tube 205F each preferably contain resin and/or metal, and are preferably made of resin or metal. Examples of the resin include fluororesin, epoxy resin, and silicone. Examples of the metal include stainless steel. The tip member 205L preferably contains metal, and more preferably consists of metal. Preferably, the metal is aluminum, copper, silver, gold, or an alloy thereof. These metals are preferable because the temperature easily decreases.

As shown in FIG. 21, the proximal end 207a of the balloon 207 is fixed to the outer surface of the distal end 206b of the outer tube 206, and the distal end 207b of the balloon 207 is fixed to the outer surface of the distal end 206b of the outer tube 206. Preferably, it is fixed to the outer surface of the distal end 205Eb. This makes it easier to insert the balloon 207 into the varicose vein.

Hereinafter, a device for cooling varicose veins according to an embodiment will be described with reference to FIGS. 23 to 32, 34, and 35. FIG. 23 is a side view of the catheter of the varicose vein cooling device according to the embodiment, and FIG. 24 is a partially enlarged view of the catheter. FIG. 25 is a schematic view of the varicose vein cooling balloon catheter inserted into the varicose vein via the catheter of FIG. 23. FIG. 26 is a schematic diagram when the balloon in FIG. 25 is inflated to cool the inside of the varicose vein, and FIG. 27 is a schematic diagram when the balloon catheter for cooling varicose veins in FIG. 26 is recovered. FIG. 28 is a schematic diagram of the varicose vein cooling device of FIG. 27 when venous blood is suctioned by the catheter and an occluder is supplied into the varicose vein. 29 shows the AA cross section in FIG. 24, FIG. 30 shows a modification of the BB cross section in FIG. 24, FIG. 31 shows the CC cross section of the catheter in FIG. 24, and FIG. , shows a modification of the cross section of the catheter shown in FIG. 24 taken along the line CC. 34 and 35 are axial cross-sectional views at the distal end of a modified example of the second tube of the catheter of FIG. 23. FIG. 36 is a schematic diagram of a varicose vein cooling balloon catheter of a varicose vein cooling device according to another embodiment and its peripheral equipment.

As shown in FIG. 25, the varicose vein cooling device 200 according to the embodiment includes a varicose vein cooling balloon catheter 202 and a catheter 201 having a shaft 210 extending in the longitudinal direction X. 210 has a first lumen 211 that extends in the longitudinal direction X and sucks venous blood 292 using negative pressure. As a result, as shown in FIGS. 25 to 28, after inflating the balloon 207 of the balloon catheter 202 to cool the varicose veins 291 from inside using the varicose vein cooling device 200, venous blood flows from the first lumen 211. By suctioning the varicose veins 292, the varicose veins 291 can be easily contracted. Furthermore, by contracting the varicose veins 291, even when using an occluder 240, which will be described later, the occluded effect can be easily exerted at a low dose.

In this specification, the proximal side of the shaft 210 of the catheter 201 means the user's proximal side in the extending direction of the shaft 210, and the distal side of the shaft 210 means the proximal side in the extending direction of the shaft 210. The position side means the opposite side. Further, the direction in which the shaft 210 extends is referred to as a longitudinal direction X.

The varicose vein cooling balloon catheter 202 is preferably inserted into the first lumen 211. This eliminates the need to separately provide a lumen for inserting the varicose vein cooling balloon catheter 202, so the diameter of the catheter 201 can be reduced.

The first lumen 211 preferably has a first distal opening 213 at its distal portion, and more preferably has a first distal opening 213 at its distal end. Thereby, by pushing out the varicose vein cooling balloon catheter 202 from the first distal opening 213 of the first lumen 211 so that at least the balloon 207 is exposed, the balloon 207 can be expanded and cooled. Further, it is preferable that the varicose vein cooling balloon catheter 202 is not fixed to the catheter 201 and is movable in the longitudinal direction X of the shaft 210.

The maximum outer diameter of the balloon 207 when expanded is preferably larger than the maximum outer diameter of the shaft 210. This allows the outer surface of the balloon 207 to easily come into contact with the inner wall of the varicose vein 291. On the other hand, the maximum outer diameter of the balloon 207 when expanded is preferably 10 times or less, more preferably 5 times or less, than the maximum outer diameter of the shaft 210. This can reduce pressure on the nerve tissue around the varicose veins 291 due to excessive expansion.

Preferably, the shaft 210 of the catheter 201 has a second lumen 212 extending in the longitudinal direction X and providing an occluder 240 to occlude the varicose vein 291. The occlusion material 240 is capable of occluding at least a portion of the varicose vein 291 after being delivered into the varicose vein 291 . Occlusion 240 is preferably an adhesive or hardener, more preferably an adhesive.

The adhesive is preferably a cyanoacrylate adhesive, a polyvinyl alcohol adhesive, a polyurethane adhesive, a gelatin adhesive, a fibrin adhesive, or a mixture thereof.

When delivered to varicose veins 291, the sclerosing agent causes regression of varicose veins 291 by causing damage to the inner wall of veins 290 at or near varicose veins 291 and inducing thrombotic occlusion and/or fibrosis. It can be promoted. Preferably, the hardener comprises a detersive hardener, a penetrating hardener, a chemically irritating hardener, or a mixture thereof. Among these, it is more preferable that the curing agent contains a detersive curing agent because the detergent curing agent has few side effects. Detergent hardening agents can interfere with the lipids of endothelial cells and cause endothelial cell damage. The detersive curing agent is preferably polidocanol, ethanolamine oleate, sodium tetradecyl sulfate, sodium morinate, or a mixture thereof, and more preferably polidocanol. When the curing agent contains a detersive curing agent, it is more preferable that it contains a solvent such as ethanol. Osmotic sclerosing agents can induce dehydration of endothelial cells due to hypertonic osmotic pressure and cause endothelial damage. Preferably, the osmotic curing agent is a 10-25% hypertonic saline solution or a saline solution containing dextrose. Chemically irritating sclerosing agents can act directly on endothelial cells to cause irreversible damage. Preferably, the chemically irritating curing agent is dichromic glycerin, polyiodide, or a mixture thereof.

The curing agent is preferably a foam curing agent. The foam hardening agent is a foamy hardening agent, and the foamy shape increases the contact area between the hardening agent and the inner wall of the varicose veins 291, making it difficult for the hardening agent to be washed away by blood flow. Furthermore, the amount of curing agent used can be reduced.

In order to supply the occlusion material 240 from the second lumen 212 to the varicose vein 291, for example, an occlusion material syringe may be used. Preferably, the obturator injector is indirectly coupled to the proximal end 12A of the second lumen 212 via a tube. Examples of the obturator injector include a piston-cylinder mechanism including a piston and a cylinder, a syringe, and the like.

As shown in FIG. 36, the varicose vein cooling device 200 may include a heating member 250. Preferably, heating member 250 is placed outside the body. By heating the vicinity of the varicose veins from outside the body using the heating member 250, damage to the surrounding tissues of the varicose veins due to excessive cooling of the varicose vein cooling balloon catheter 202 can be easily avoided. In this case, examples of the heating member 250 include a fan type heater that heats by emitting hot air, an infrared type heater that emits infrared rays, and a radiation type heater that heats by generating heat without emitting air. Among these, a radiation type heater is preferable. The radiation type heater is preferably a sheet-shaped heater. Examples of sheet-shaped heaters include rubber heaters, film heaters, and the like. Note that in the varicose vein cooling device 200 shown in FIG. 36, the catheter 201 is not shown.

As shown in FIG. 36, the varicose vein cooling device 200 may include a temperature sensor 251. For example, varicose vein cooling balloon catheter 202 may have a temperature sensor 251 at the distal end of the tube located within balloon 207. Examples of the temperature sensor 251 include a thermocouple, a resistance temperature detector, a bimetal thermometer, a radiation thermometer, a thermistor thermometer, and the like. In FIG. 36, a thermocouple is placed within the shaft 204 as the temperature sensor 251, and a temperature measuring junction 251p of the thermocouple is placed on a tube located inside the balloon 207. Further, the temperature sensor 251 may be placed on the distal tip 207F described above. Further, the temperature sensor 251 does not need to be placed on the varicose vein cooling balloon catheter 202, and may be placed on the surface of the skin. The information acquired by the temperature sensor 251 is preferably transmitted to the temperature control member 209C by wire or wirelessly. Based on this information, temperature control member 209C may communicate a signal to regulator 209E and/or fluid evacuation pump 209F. For example, when the temperature detected by the temperature sensor 251 falls below a certain temperature, the temperature control member 209C transmits a signal to the regulator 209E and/or the fluid discharge pump 209F to reduce the flow rate of the fluid or remove the fluid. It may be configured to stop the supply. This makes it easier to avoid damage to the surrounding tissues of the varicose veins due to an excessive drop in temperature. The signal from the temperature sensor 251 may be transmitted to the temperature control member 209C by wire or wirelessly.

The temperature control member 209C may be configured to transmit a signal to the heating member 250 to heat it when the temperature detected by the temperature sensor 251 falls below a certain temperature. This makes it easier to avoid damage to the surrounding tissues of the varicose veins due to excessive cooling of the varicose vein cooling balloon catheter 202. The signal from the temperature control member 209C may be transmitted to the heating member 250 by wire or wirelessly.

As shown in FIG. 36, the varicose vein cooling device 200 may include a temperature indicator 252. Preferably, temperature indicator 252 is placed outside the body. For example, the information acquired by the temperature sensor 251 may be transmitted by wire or wirelessly to the temperature display 252 placed outside the body. The user may reduce the fluid flow rate or stop the fluid supply by checking the temperature displayed on the temperature display 252 and directly operating the regulator 209E and/or the fluid discharge pump 209F. However, by directly operating the heating member 250, the temperature of the tissue surrounding the varicose veins may be increased from the skin. Preferably, temperature indicator 252 includes a liquid crystal display.

As mentioned above, the varicose vein cooling device 200 may include a heating member 250, a temperature sensor 251, a temperature indicator 252, and/or a temperature control member 209C. Further, these heating member 250, temperature sensor 251, and/or temperature indicator 252 may be configured to be controlled by the above-mentioned temperature control member 209C, or may be configured to be controlled by another control member. It may be configured as follows. The signal related to the control may be transmitted by wire or by wireless communication. Note that these members do not necessarily need to be separated, and two or more may be configured integrally.

Below, the catheter 201 included in the varicose vein cooling device 200 will be described in detail. As shown in FIGS. 23, 24, and 29, the first lumen 211 has a first distal opening 213 at its distal portion, and is located more proximally than the proximal end 213A of the first distal opening 213 of the shaft 210. In a cross section perpendicular to the longitudinal direction X in the side region, the cross-sectional area of the second lumen 212 is preferably smaller than the cross-sectional area of the first lumen 211. This makes it easier to prevent the venous blood 292 from flowing into the second lumen 212. Further, since the cross-sectional area of the first lumen 211 is relatively large, it is possible to easily aspirate the venous blood 292.

As shown in FIGS. 23, 24, and 29, the region where the cross-sectional area of the second lumen 212 in the direction perpendicular to the longitudinal direction 1, the region is preferably within 1 cm from the proximal end 213A, more preferably within 5 cm from the proximal end 213A, and more preferably within 5 cm from the proximal end 213A. The region is more preferably within 10 cm from the proximal end 213A, and even more preferably the region is within 20 cm from the proximal end 213A. Further, it is particularly preferable that the region is a region proximal to the proximal end 213A of the first distal opening 213 of the shaft 210 and extending to the proximal end 210A of the shaft 210. That is, it is particularly preferable that the region is the entire region proximal to the proximal end 213A of the first distal opening 213 of the shaft 210. Note that when the varicose vein cooling catheter 201 has the handle member 230, the proximal end 210A of the shaft 210 corresponds to the distal end of the handle member 230.

In a cross section perpendicular to the longitudinal direction , more preferably 0.5 times or less. On the other hand, the cross-sectional area of the second lumen 212 is preferably 0.01 times or more, more preferably 0.05 times or more, the cross-sectional area of the first lumen 211.

The shapes of the first lumen 211 and the second lumen 212 in a cross section perpendicular to the longitudinal direction X are preferably circular, elliptical, polygonal, or rounded polygonal, and are circular or elliptical. It is more preferable. This makes it easier to absorb the venous blood 292 from the first lumen 211, and makes it easier to inject the occlusion material 240 into the second lumen 212. In addition, the outer edges of the first lumen 211 and the second lumen 212 in the cross section preferably include a straight line, a curved line, or a straight line and a curved line, and more preferably include a curved line or a straight line and a curved line, and preferably include a curved line, or a straight line and a curved line, respectively. Even more preferably, it consists of: Note that the cross-sectional shapes of the first lumen 211 and the second lumen 212 may be the same or different.

For example, a suction device may be used to suck the venous blood 292 from the first lumen 211 using negative pressure. Thereby, blood can be easily removed from the first lumen 211. Examples of the suction device include a suction mechanism including a pump and a waste liquid storage container, a syringe, and the like.

It is preferable that the second lumen 212 has a second distal opening 214 located more distally than the distal end 213B of the first distal opening 213. The distal side refers to the distal side of the shaft 210. The second distal opening 214 is located more distally than the distal end 213B of the first distal opening 213, thereby making it easier to insert the balloon 207 of the varicose vein cooling balloon catheter 202 into the varicose vein 291. be able to.

The distance from the distal end 213B of the first distal opening 213 to the second distal opening 214 in the longitudinal direction X is 1.5 of the diameter of the first lumen 211 at the proximal end 213A of the first distal opening 213. It is preferable that it is twice or more. Thereby, it is possible to easily supply the occluder 240 to the distal side of the varicose vein 291 within the contracted varicose vein 291 . The magnification is more preferably 2.0 times or more, more preferably 5.0 times or more. On the other hand, the magnification is preferably 50 times or less, more preferably 20 times or less. This makes it easier to inject the obturator 240 into the area within the varicose vein 291 that has become narrowed due to suction through the first distal opening 213 .

The shaft 210 has an inclined surface 219 that is inclined with respect to the longitudinal direction It is preferable to be closer to the second lumen 212 than the second lumen 212 . As a result, as shown in FIG. 28, the inner wall of the varicose vein 291 can be brought into close contact with the distal end portion 210b of the shaft 210 when venous blood 292 is aspirated, making it easier to reduce the volume of the varicose vein 291. can. Furthermore, since the inclined surface 219 has the first distal opening 213, the area of the first distal opening 213 can be increased, making it easier to efficiently aspirate venous blood 292. .

As shown in FIGS. 23, 24, and 28, the inclined surface 219 is preferably a flat surface, a curved surface, or a combination of a flat surface and a curved surface, and more preferably a flat surface. This makes it easier to bring the inner wall of the varicose vein 291 into close contact with the distal end portion 210b of the shaft 210 when venous blood 292 is aspirated.

At the proximal end 219A of the inclined surface 219, the cross-sectional area of the second lumen 212 is preferably smaller than the cross-sectional area of the first lumen 211. When inserting the shaft 210 into the vein 290, the load due to insertion resistance tends to concentrate near the proximal end 219A, but as a result of the load being relieved by the first lumen 211 having a large area, The inner cavity 212 becomes difficult to deform. Note that these cross-sectional areas are cross-sectional areas in a cross section perpendicular to the longitudinal direction X.

The cross-sectional shape of the first lumen 211 at the proximal end 219A of the inclined surface 219 and the proximal end 210A of the shaft 210 is preferably the same shape. Moreover, it is more preferable that the cross-sectional shape of the first inner cavity 211 from the proximal end 219A of the inclined surface 219 to the proximal end 210A of the shaft 210 is constant. This makes it easier to suction from the first lumen 211. Note that the cross-sectional shape is a shape in a cross section perpendicular to the longitudinal direction X.

The cross-sectional shape of the second lumen 212 at the proximal end 219A of the inclined surface 219 and the proximal end 210A of the shaft 210 is preferably the same shape. Further, it is more preferable that the cross-sectional shape of the second inner cavity 212 from the proximal end 219A of the inclined surface 219 to the proximal end 210A of the shaft 210 is constant. This makes it easier to inject the occlusion material 240 into the second lumen 212. Note that the cross-sectional shape is a shape in a cross section perpendicular to the longitudinal direction X.

As shown in FIGS. 23 and 24, the shaft 210 preferably includes a first tube 221 having a first lumen 211 and a second tube 222 having a second lumen 212. This allows the first lumen 211 and the second lumen 212 to have different characteristics.

As shown in FIGS. 23 and 24, the distal end 221B of the first tube 221 is located more proximally than the distal end 222B of the second tube 222, and the proximal end 221A of the first tube 221 is located closer to the distal end 222B of the second tube 222. It is preferable that the proximal end 222A of the two tubes 222 be located on the distal side. As a result, the suction path for venous blood 292 can be shortened, so that venous blood 292 can be efficiently suctioned. The proximal side and distal side are the proximal side and distal side in the longitudinal direction X.

The second tube 222 is preferably linear from the proximal end 222A to the distal end 222B. This allows the obstruction 240 to be easily injected into the second tube 222.

The outer diameter of the second tube 222 distal to the distal end 221B of the first tube 221 is preferably smaller than the outer diameter of the first tube 221 at the proximal end 219A of the inclined surface 219. This makes it easier to prevent the venous blood 292 from flowing into the second tube 222. Furthermore, it is more preferable that the distal end 222B of the second tube 222 is located on the more distal side than the distal end 221B of the first tube 221. This allows the varicose veins 291 in the portion distal to the first tube 221 to be easily contracted during suction using the first tube 221 .

As shown in FIGS. 23, 24, 29, etc., the second tube 222 is tubular, but it is preferable that the second tube 222 has a flattened portion at least at the distal end 222b. . Since at least a portion of the second tube 222 is flat, the volume of the varicose veins 291 can be easily reduced when the venous blood 292 is suctioned. Specifically, when the venous blood 292 is aspirated, the varicose veins 291 do not remain approximately circular but deform and contract into a flat shape, so at least the distal end 222b of the second tube 222 should be flat. This makes the varicose veins 291 more likely to contract.

As shown in FIG. 30, the second tube 222 has a flat part 222d at least at the distal end part 222b, and the center of the first tube 221 in the cross section perpendicular to the longitudinal direction X of the flat part 222d. The maximum length L1 of the flat portion 222d in the first direction D1 passing through the center of the second tube 222 is longer than the maximum length L2 of the flat portion 222d in the second direction D2 perpendicular to the first direction D1. It is more preferable that the length is also short. Thereby, when venous blood 292 is suctioned, varicose veins 291 can be easily contracted in the first direction D1. The second tube 222 may have a flat portion 222d over its entire length.

The shape of the outer edge of the flat portion 222d of the second tube 222 in a cross section perpendicular to the longitudinal direction preferable.

The first tube 221 and the second tube 222 may or may not be directly fixed. For example, the first tube 221 and the second tube 222 may be directly fixed by adhesive, welding, or the like.

As shown in FIGS. 23, 24, and 31, the shaft 210 may include a third tube 223 having a lumen extending in the longitudinal direction X. By arranging the first tube 221 and the second tube 222 in the inner cavity of the third tube 223, the third tube 223 wraps around the first tube 221 and the second tube 222. The tube 222 can be fixed. Preferably, the third tube 223 is a heat shrink tube. The third tube 223 preferably contains a fluororesin and/or a polyvinyl chloride resin, and more preferably consists of a fluororesin and/or a polyvinyl chloride resin.

The first tube 221 and the second tube 222 each preferably contain resin, and are more preferably made of resin. Preferred resins include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluororesins, polyvinyl chloride resins, aromatic polyetherketone resins, polyether polyamide resins, polyester elastomers, polyimide resins, or mixtures thereof. These may be used alone or in combination of two or more.

The first tube 221 and the second tube 222 may each have an inner layer and an outer layer. Preferably, the outer layer comprises a polyamide resin, a polyester resin, a polyurethane resin, a polyolefin resin, a fluororesin, or a mixture thereof. The inner layer preferably contains a fluororesin, a polyolefin resin such as high-density polyethylene, or a mixture thereof.

The first tube 221 and the second tube 222 may each include a braided body. The braided body is preferably formed by knitting linear bodies into a tubular shape. The braided body preferably contains metal, resin, or both, more preferably contains metal, and still more preferably consists of metal. Examples of the metal include stainless steel such as SUS304 and SUS316, spring steel, Co--Cr alloy, Ni--Ti alloy, and the like. Further, the braided body may include piano wire, oil tempered wire, or the like.

As shown in FIG. 34, the second tube 222 may have a valve 222v on the second lumen 212 side at the distal end 222b. Preferably, the valve 222v extends from the distal side toward the proximal side. According to such a valve 222v, for example, when supplying the occluded substance 240 from the first tube 221 into the varicose vein 291 while suctioning from the second tube 222, it is possible to prevent an excessive amount of the occluded substance 240 from being supplied due to negative pressure. Easier to prevent. Further, such a valve 222v can reduce the flow of the occluded substance 240 remaining in the second lumen 212 into the body after a predetermined amount of the occluded substance 240 has been supplied. Further, as shown in FIG. 35, the valve 222v may extend from the proximal side to the distal side. According to such a valve 222v, it is possible to easily prevent the obstruction 240 supplied from the second lumen 212 into the varicose vein 291 from flowing back into the second lumen 212. Valve 222v preferably comprises an elastomer, rubber, or a mixture thereof, and more preferably comprises an elastomer, rubber, or a mixture thereof. This makes it easier to elastically deform the valve 222v, making it difficult to damage the valve 222v. Elastomers include polyamide elastomers, polyolefin elastomers, polyurethane elastomers, or mixtures thereof. Rubbers include silicone rubber, latex rubber, or mixtures thereof. Note that the valve 222v may be made of the same material as the second tube 222, or may be formed integrally with the second tube 222. The number of valves 222v is preferably one or more and ten or less. More preferably, the number is 2 or more and 4 or less.

As shown in FIG. 32, the shaft 210 does not necessarily have to have a first tube 221 and a second tube 222, but can be an elongated body having a first lumen 211 and a second lumen 212. It's okay. Examples of the shape of the elongated body include a columnar shape, an elliptical columnar shape, a polygonal columnar shape, and a rounded polygonal columnar shape. The elongated body preferably contains the resin mentioned in the description of the first tube 221 and the second tube 222, and more preferably consists of the resin.

Preferably, the shaft 210 does not have a balloon. Thereby, the diameter of the shaft 210 can be reduced, and the shaft 210 can be easily inserted into the varicose vein 291. Further, the shaft 210 may have a lumen extending in the longitudinal direction X other than the first lumen 211 and the second lumen 212.

The maximum outer diameter of the shaft 210 is preferably 1 mm or more and 12 mm or less, more preferably 3 mm or more and 8 mm or less. This makes it easier to insert the shaft 210 into the varicose veins of the lower limbs. The maximum diameter of the first inner cavity 211 is preferably 0.5 mm or more and 5.0 mm or less, more preferably 1.0 mm or more and 4.0 mm or less. On the other hand, the maximum diameter of the second inner cavity 212 is preferably 0.4 mm or more and 4.0 mm or less, and more preferably 0.8 mm or more and 3.5 mm or less. Further, the maximum diameter of the second lumen 212 is preferably smaller than the maximum diameter of the first lumen 211.

The shaft 210 may have a coaxial structure that is a multi-tubular structure, but as shown in FIG. It is preferable. The multi-lumen structure allows the space of the first lumen 211 to be enlarged, making it easier to aspirate venous blood 292. Further, it is preferable that the first lumen 211 and the second lumen 212 do not communicate with each other. This makes it easier to perform suction through the first lumen 211 and inject the obturator 240 into the second lumen 212.

As shown in FIG. 23, the varicose vein cooling catheter 201 preferably has a handle member 230 at its proximal end. The handle member 230 preferably has a lumen 231 in which the first tube 221 is embedded and communicates with the lumen of the first tube 221. By directly or indirectly connecting a suction device to the lumen 231, negative pressure can be applied to the lumen of the first tube 221 to aspirate the venous blood 292. Examples of the suction device include a suction mechanism including a pump and a waste liquid storage container, a syringe, and the like. The suction device may be indirectly connected to the proximal end 211A of the first lumen 211 via a tube. The shape of the lumen 231 of the handle member 230 is preferably tapered. Further, the handle member 230 preferably has a lumen 232 in which the second tube 222 is embedded and communicates with the lumen of the second tube 222. Thereby, the obturator 240 can be injected from the lumen 232 toward the lumen of the second tube 222 . The shape of the lumen 232 is preferably tapered. The handle member 230 preferably contains resin, and is preferably made of resin.

Below, a method for cooling varicose veins according to an embodiment of the second invention of the present application will be described. As shown in FIGS. 25 to 28, the method for cooling varicose veins 291 according to the embodiment includes the steps of inserting the balloon 207 of the balloon catheter 202 into the vein 290, supplying cooled fluid into the balloon 207, and/or cooling the varicose veins 291 of the veins 290 by cooling the fluid supplied within the balloon 207.

The varicose vein 291 is a part of the varicose vein 290, and it is preferable to insert the balloon catheter 202 into the varicose vein 291 from a normal portion of the vein 290 other than the varicose vein 291; You may.

The step of supplying the cooled fluid into the balloon 207 allows the balloon 207 to expand and reduce its temperature, thereby causing the outer surface of the balloon 207 to contact the inner wall of the varicose vein 291 while keeping the outer surface of the balloon 207 in contact with the inner wall of the varicose vein 291. The inner wall can be cooled. In this step, for example, liquefied nitrogen among the above-mentioned fluids may be supplied into the balloon 207.

The step of cooling the fluid supplied within the balloon 207 allows the balloon 207 to expand and reduce its temperature so that the outer surface of the balloon 207 contacts the inner wall of the varicose vein 291 while The inner wall can be cooled. As a mode of cooling the fluid supplied into the balloon 207, a room temperature or low temperature fluid is supplied into the balloon 207, and the fluid is expanded within the lumen 207C of the balloon 207, thereby lowering the temperature of the fluid. Examples include a cooling mode, a mode in which a room temperature or low temperature fluid is supplied into the balloon 207, and the fluid is cooled by the cooling unit 205K.

When cooling the varicose veins 291, it is preferable to freeze at least a portion of the varicose veins 291. This makes it easier for the varicose veins 291 to retract.

The method for cooling varicose veins according to the embodiment preferably includes a step of sucking venous blood 292 within varicose veins 291. This makes it easier to shrink the varicose veins 291. Furthermore, this allows the usage amount of the occluding material 240 to be reduced when the occluding material 240 is used. The suction is preferably performed after the balloon 207 is expanded and cooled. Thereby, unintentional expansion of the balloon 207 can be prevented. Further, it is preferable that the balloon 207 of the balloon catheter 202 is deflated and recovered before the suction.

Although not shown, the method for cooling varicose veins according to the embodiment preferably includes a step of heating the skin with a heating member. For example, by heating the skin near the varicose veins 291 from outside the body with a heating member, damage to the tissues surrounding the varicose veins 291 due to excessive cooling of the balloon 207 can be easily avoided. Therefore, it is preferable that the heating is performed after cooling by the balloon 207, but heating may be performed before cooling.

The method for cooling varicose veins according to the embodiment preferably includes a step of supplying an occluder 240 that occludes the varicose veins 291 into the varicose veins 291. Since at least a portion of the varicose veins 291 are occluded by the obstructor 240, regression of the varicose veins 291 can be promoted. Obturator 240 can be delivered into varicose vein 291 from second lumen 212 of catheter 201, for example. Furthermore, it is preferable to inject the occlusion material 240 into the varicose vein 291 while moving the catheter 201 from the distal portion of the varicose vein 291 toward the proximal portion. This makes it easier to prevent the obstruction 240 from flowing into the first lumen 211. Further, in supplying the occlusion material 240, the occlusion material 240 may be supplied into the varicose vein 291 using a syringe. Note that the proximal part of the varicose vein 291 is the side of the varicose vein 291 that is far from the heart, and the distal part of the varicose vein 291 is the side of the varicose vein 291 that is close to the heart.

In the method for cooling varicose veins according to the embodiment, it is preferable to use the balloon catheter 202, the balloon catheter 203, or the varicose vein cooling device 200 described above. For details, refer to the descriptions of the

balloon catheters

202, 203 and the varicose vein cooling device 200.

This application is based on Japanese Patent Application No. 2022-036695 filed on March 9, 2022, Japanese Patent Application No. 2022-036697 filed on November 30, 2022, and Japanese Patent Application No. 2022-036695 filed on March 9, 2022. No. 191946 and Japanese Patent Application No. 2022-191948. Japanese Patent Application No. 2022-036695 filed on March 9, 2022, Japanese Patent Application No. 2022-036697, Japanese Patent Application No. 2022-191946 filed on November 30, 2022, The entire contents of the specification of Japanese Patent Application No. 2022-191948 are incorporated herein by reference.

1, 99 Catheter for cooling varicose veins 2 Suction device 2a Tube 3 Cooling member 3b Distal end portion 3c Cooling portion 3d Flat portion 3e Inner tube 3f Middle tube 3g Outer tube 3h Tip member 3i Fluid supply lumen 3j Vacuum lumen 3k Fluid discharge lumen 3l Tip lumen 3t Tip tip 3x Narrow diameter portion 3y Tapered portion 3z Large diameter portion 4 Temperature control member 5 Fluid storage 6 Regulator 7 Fluid discharge pump 8a, 8b Tube 9a, 9b Communication line 10 Shaft 10A Proximal end 10b Distal end X Longitudinal direction 11 First lumen 11A Proximal end 12 Second lumen 13 First distal opening 13A Proximal end 13B Distal end 14 Second distal opening 19 Inclined surface 19A Proximal end 19B Distal end 21 First tube 21A Proximal end 21B Distal end 22 Second tube 22A Proximal end 22B Distal end 22b Distal end 22d Flat part 23 Third tube D1 First direction D2 Second direction 30 Handle member 31, 32 Lumen 40 Heating member 41 Temperature sensor 41p Temperature measuring contact 42 Temperature display 90 Vein 91 Varicose veins 92 Venous blood 100 Varicose vein cooling device 200 Varicose vein cooling device 201 Catheter 202 , 202, 203 Balloon catheter D Longitudinal direction 204 Shaft 204a Proximal end 204b Distal part 204C Fluid supply lumen 204CB Distal end 204D Fluid discharge lumen 204DB Distal end 205 Inner tube 205a Proximal end 205A Near Distal end 205B Distal end 205C Fluid supply tube 205D Fluid discharge tube 205E Elongated body 205Eb Distal end 205F Cooling tube 205G Inner tube 205H Outer tube 205I Refrigerant supply cavity 205J Refrigerant discharge cavity 205K Cooling section 205L Tip member 206 Outer tube 206a Proximal end 206b Distal end 206A Proximal end 206B Distal end 207 Balloon 207a Proximal end 207b Distal end 207C Lumen 207F Distal tip 208 Handle member 209C Temperature control member 209D Fluid reservoir 209E Regulator 209F Fluid discharge pump 209G, 209H Tube 209I, 209J Communication line 210 Shaft 210A Proximal end 210b Distal end X Longitudinal direction 211 First lumen 211A Proximal end 212 Second lumen 213 First distal opening 213A Proximal end 213B Distal end 214 Second distal opening 219 Inclined surface 219A Proximal end 219B Distal end 221 First tube 221A Proximal end 221B Distal end 222 Second tube 222A Proximal end 222B Distal end 222b Distal end 222d Flat part 222v Valve 223 Third tube D1 First direction D2 Second direction 230 Handle member 231, 232 Inner cavity 240 Obstruction 250 Heating member 251 Temperature sensor 251p Temperature measuring junction 252 Temperature indicator 290 Veins 291 Varicose veins 292 Venous blood

Claims

having a longitudinally extending shaft;
The shaft is
a first lumen extending in the longitudinal direction and sucking venous blood by negative pressure;
a second lumen extending in the longitudinal direction and into which a cooling member is inserted;
The first lumen has a first distal opening at a distal portion, and in a cross section perpendicular to the longitudinal direction in a region proximal to the proximal end of the first distal opening of the shaft, A varicose vein cooling catheter in which the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen.
The catheter for cooling varicose veins according to claim 1, wherein the second lumen has a second distal opening located more distally than the distal end of the first distal opening.
The shaft has an inclined surface that is inclined with respect to the longitudinal direction, the inclined surface has the first distal opening, and the distal end of the inclined surface is closer to the first distal opening than the proximal end. The varicose vein cooling catheter of claim 1 proximate to the second lumen.
The varicose vein cooling catheter according to claim 3, wherein the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen at the proximal end of the inclined surface.
The varicose vein cooling catheter according to claim 1, wherein the shaft has a first tube having the first lumen and a second tube having the second lumen.
The distal end of the first tube is located more proximally than the distal end of the second tube, and the proximal end of the first tube is located more distally than the proximal end of the second tube. The catheter for cooling varicose veins according to claim 5, which is located at.
The second tube has a flattened portion at least at its distal end,
In a cross section perpendicular to the longitudinal direction of the flat part, the maximum length of the flat part in a first direction passing through the center of the first tube and the center of the second tube is the maximum length of the flat part in the first direction. The catheter for cooling varicose veins according to claim 5, wherein the length is shorter than the maximum length of the flattened portion in the second direction perpendicular to the varicose vein cooling catheter.
The catheter for cooling varicose veins according to claim 1, wherein the shaft does not have a balloon.
a catheter having a longitudinally extending shaft;
It has a cooling member,
The device for cooling varicose veins, wherein the shaft extends in the longitudinal direction and has a first lumen for sucking venous blood by negative pressure.
The device for cooling varicose veins according to claim 9, wherein the cooling member is elongated and has a flattened portion at least at its distal end.
The catheter is a varicose vein cooling catheter according to any one of claims 1 to 8,
The device for cooling varicose veins according to claim 9 or 10, wherein the cooling member is inserted into the second lumen.
The device for cooling varicose veins according to claim 9 or 10, wherein a suction device is connected directly or indirectly to the proximal end of the first lumen.
The device for cooling varicose veins according to claim 9 or 10, further comprising a temperature control member that is connected to the cooling member and controls the temperature of the cooling section of the cooling member.
The cooling member includes a shaft extending in a longitudinal direction;
a balloon provided at a distal portion of the shaft, the balloon catheter comprising:
The shaft of the cooling member is
a fluid supply lumen extending in the longitudinal direction and supplying fluid to the balloon;
a fluid discharge lumen extending in the longitudinal direction and discharging fluid from the balloon;
The device for cooling varicose veins according to claim 9, wherein the balloon has a cooling fluid therein.
The device for cooling varicose veins according to claim 14, wherein in a cross section perpendicular to the longitudinal direction, the cross-sectional area of the fluid supply lumen is smaller than the cross-sectional area of the fluid discharge lumen.
The device for cooling varicose veins according to claim 14, wherein the shaft of the cooling member has a cooling section within the balloon that cools the fluid.
The device for cooling varicose veins according to claim 14, wherein the cooling member is inserted into the first lumen.
15. The device for cooling varicose veins of claim 14, wherein the shaft of the catheter has a second lumen extending in the longitudinal direction and providing an occluder to occlude the varicose veins.
The first lumen has a first distal opening at a distal portion, and in a cross section perpendicular to the longitudinal direction in a region proximal to the proximal end of the first distal opening of the shaft, 19. The varicose vein cooling device of claim 18, wherein the second lumen has a smaller cross-sectional area than the first lumen.
20. The device for cooling varicose veins according to claim 19, wherein the second lumen has a second distal opening located more distally than the distal end of the first distal opening.
The shaft of the catheter has an inclined surface that is inclined with respect to the longitudinal direction, the inclined surface has the first distal opening, and the distal end of the inclined surface has a proximal end. 20. The varicose vein cooling device of claim 19, wherein the varicose vein cooling device is closer to the second lumen than the second lumen.
22. The device for cooling varicose veins according to claim 21, wherein the cross-sectional area of the second lumen is smaller than the cross-sectional area of the first lumen at the proximal end of the inclined surface.
19. The varicose vein cooling device of claim 18, wherein the shaft of the catheter includes a first tube having the first lumen and a second tube having the second lumen.
The distal end of the first tube is located more proximally than the distal end of the second tube, and the proximal end of the first tube is located more distally than the proximal end of the second tube. 24. A device for cooling varicose veins according to claim 23, located at .
The second tube has a flattened portion at least at its distal end,
In a cross section perpendicular to the longitudinal direction of the flat part, the maximum length of the flat part in a first direction passing through the center of the first tube and the center of the second tube is the maximum length of the flat part in the first direction. 24. The device for cooling varicose veins according to claim 23, wherein the device is shorter than the maximum length of the flattened portion in the second direction perpendicular to .
15. The varicose vein cooling device of claim 14, wherein the shaft of the catheter does not include a balloon.