JP2023149924A - Balloon catheter and pressure measurement processing system - Google Patents

Abstract

To provide a balloon catheter capable of measuring a blood pressure accurately and stably by reducing an impact of electric noise and an impact by a drift of a sensor.SOLUTION: A balloon catheter 10A used for closing a blood vessel includes: a catheter tube 20A; a balloon part 50 that can be expanded and contracted, at least proximal end part of the same being connected to the catheter tube 20A; a first optical sensor 110 capable of measuring a pressure using light, which is disposed on a distal side as compared to the balloon part 50 for measuring a blood pressure in a blood vessel on a distal side of the balloon part 50; and a second optical sensor 120 capable of measuring a pressure using light, which is disposed on a proximal side as compared to the balloon part 50 for measuring a blood pressure in a blood vessel on a proximal side of the balloon part 50.SELECTED DRAWING: Figure 2

Description

The present invention relates to a balloon catheter and pressure measurement processing system used to occlude blood vessels.

Conventionally, balloon catheters are known, in which a balloon part is provided at the tip of the catheter, and by inserting the tip into a blood vessel and expanding the balloon part, the catheter can occlude the inside of the blood vessel and control blood flow. It is being This type of balloon catheter is also called an occlusion catheter or an occlusion balloon catheter, and is inserted into the descending aorta from the femoral artery and inflates the balloon provided at its tip to block blood flow in the aorta. It is used to maintain blood flow and function of the brain and heart.

If the degree of expansion of the balloon section cannot be accurately determined when the balloon is expanded within a blood vessel, complications may occur. Examples of complications include vascular rupture due to excessive expansion of the balloon, lower limb ischemia due to prolonged hemostasis, and ischemia-reperfusion injury due to sudden deflation of the expanded balloon. Furthermore, there is a possibility that blood flow may not be appropriately blocked due to insufficient expansion of the balloon portion, resulting in blood flow leakage.

U.S. Pat. No. 5,005,001 discloses a dilatation catheter member defining a longitudinal axis and having an atraumatic tip at a distal end of the catheter; an occlusion balloon that is inflatable and deflatable attached to the dilatation catheter member; an inflatable spine attached to the member, an occlusion catheter system is described having a portion of the outer surface of the balloon contacting the outer surface of the spine when the occlusion balloon and the inflatable spine are in an inflated configuration. The occlusion catheter system described in Patent Document 1 is equipped with a distal pressure sensor consisting of an electronic pressure sensor distal to the occlusion balloon, and a proximal pressure sensor consisting of an electronic pressure sensor proximal to the occlusion balloon. Blood pressure and proximal blood pressure can be monitored.

Patent No. 6408176

The electronic pressure sensor used in the occlusion catheter system described in Patent Document 1 has a characteristic of being susceptible to electrical noise. For example, when a medical device that uses electrical energy such as an electric scalpel is used together with the occlusion catheter system described in Patent Document 1, the electronic pressure sensor cannot accurately measure blood pressure due to electrical noise. It disappears. As a result, there is a possibility that the degree of expansion of the balloon portion cannot be accurately determined.

Further, the electronic pressure sensor used in the occlusion catheter system described in Patent Document 1 has a characteristic that it is susceptible to fluctuations (drift) due to temperature changes and the passage of time. If drift occurs in the electronic pressure sensor and the measurement accuracy of the electronic pressure sensor decreases, it becomes impossible to accurately measure blood pressure. As a result, there is a possibility that the degree of expansion of the balloon portion cannot be accurately determined.

The present invention has been made in view of the above problems, and provides a balloon catheter and a device capable of accurately and stably measuring blood pressure by reducing the effects of electrical noise and sensor drift. The purpose is to provide a pressure measurement processing system.

In order to achieve the above object, a balloon catheter according to the present invention is a balloon catheter used for occluding a blood vessel, and includes:
catheter tube,
a balloon portion having at least a proximal end joined to the catheter tube and expandable and deflated;
a first optical sensor that is capable of measuring pressure using light and is disposed distal to the balloon section and measures blood pressure in a blood vessel distal to the balloon section;
a second optical sensor that is capable of measuring pressure using light and is disposed proximal to the balloon section and measures blood pressure in a blood vessel proximal to the balloon section;
It is characterized by having the following.

With the above configuration, blood pressure can be measured by the first optical sensor disposed on the distal side of the balloon part and the second optical sensor disposed on the proximal side of the balloon part. Based on these pressure values, it becomes possible to check the degree of expansion of the balloon section. In addition, by using an optical sensor that measures pressure using light, it is less susceptible to electrical noise and can accurately and stably measure blood pressure even when using devices that can generate electric fields, such as electric scalpels. and can be measured. Furthermore, since the optical sensor has small fluctuations (drift) due to temperature changes and the passage of time, it is possible to accurately and stably measure blood pressure even in an internal environment that can change over time.

The balloon catheter according to the present invention has the above configuration, and has a distal tip disposed at the distal end and joined to the distal end of the balloon part,
A fluid circulation lumen having a communication port communicating with the inside of the balloon portion is formed in the catheter tube in the axial direction,
The first optical sensor is housed in a first sensor accommodating portion formed in the tip tip so as to open at the outer peripheral surface of the tip tip,
The second optical sensor may be accommodated in a second sensor accommodating portion formed on a proximal side of the balloon portion of the catheter tube so as to open at an outer circumferential surface of the catheter tube.

With the above configuration, the first optical sensor and the second optical sensor can be respectively disposed on the distal tip located on the distal side of the balloon part and on the catheter tube located on the proximal side of the balloon part, and the expansion of the balloon part - Blood pressure can be measured on the distal and proximal sides of the balloon without interfering with deflation.

In the balloon catheter according to the present invention, in the above configuration, the distal end of the catheter tube may be connected to the proximal end of the distal tip.

With the above configuration, since the distal end of the catheter tube is fixed to the distal tip, the positions of the distal tip and the balloon portion can be controlled by the catheter tube.

In the balloon catheter according to the present invention, in the above configuration, the guide wire insertion hole has a distal opening opening at the distal end of the distal tip and a side opening opening at the side surface of the distal tip. It may be formed on the distal tip.

With the above configuration, by inserting the guide wire through the side opening and exposing it through the tip opening, the guide wire can be used to guide the distal end of the balloon catheter to a desired position within the body. can be guided to the location.

The balloon catheter according to the present invention has the above configuration, and includes a guidewire tube that is inserted into the fluid flow lumen of the catheter tube and has a guidewire insertion lumen formed in the axial direction,
A guidewire insertion hole is formed in the distal tip, the guidewire insertion hole having a distal opening opening at a distal end of the distal tip and a proximal opening opening at a proximal end of the distal tip,
The distal end of the guide wire tube exposed from the distal end of the catheter tube connected to the proximal end of the balloon part is connected to the proximal opening, and the guide wire insertion lumen is connected to the proximal opening. It may be in communication with the guide wire insertion hole.

With the above configuration, the distal end of the guidewire tube is fixed to the distal tip, so the positions of the distal tip and the balloon section can be controlled by the guidewire tube. In addition, by inserting the guidewire through the guidewire tube and guidewire insertion hole so that it is exposed through the tip opening of the tip, the distal end of the balloon catheter can be guided to the desired position inside the body using the guidewire. can do. Furthermore, since a small-diameter guide wire tube that can be inserted into the fluid flow lumen is placed inside the balloon section, the diameter of the balloon section when deflated can be reduced, and the distal end of the balloon catheter can be inserted into the body. This makes it easier to insert the tube into the patient's body and reduces the burden on the patient.

In the balloon catheter according to the present invention, in the above configuration, the second sensor accommodating portion may be isolated from the fluid circulation lumen.

With the above configuration, it is possible to prevent the fluid necessary for expanding the balloon section from flowing out from the second sensor accommodating section, and it is possible to appropriately expand the balloon section.

In the balloon catheter according to the present invention, in the above configuration, a sensor lumen isolated from the fluid circulation lumen is formed in the catheter tube in the axial direction, and the second sensor accommodating portion is provided in the sensor lumen. may be provided.

With the above configuration, a fluid circulation lumen and a sensor lumen are formed in the catheter tube, and a second sensor accommodating part is provided in the sensor lumen. Fluid outflow can be reliably prevented and the balloon portion can be appropriately expanded.

Further, the pressure measurement processing system according to the present invention is a pressure measurement processing system that performs processing related to the pressure value measured by the above-mentioned balloon catheter,
a first optical fiber measured by the first optical sensor based on light transmitted through a first optical fiber connected to the first optical sensor and a second optical fiber connected to the second optical sensor, respectively; The present invention is characterized by having a pressure measurement processing device including a pressure value calculation unit that calculates a pressure value and a second pressure value measured by the second optical sensor.

With the above configuration, the blood pressure measured by the first optical sensor disposed on the distal side of the balloon part and the second optical sensor disposed on the proximal side of the balloon part is set to the first pressure value and the second pressure value. It can be calculated as a value.

In the pressure measurement processing system according to the present invention, in the above configuration, the pressure measurement processing device
a fluctuation monitoring unit that monitors whether a fluctuation range of the second pressure value falls within a predetermined range when the balloon portion is expanded;
a first reference value that is the first pressure value before expanding the balloon portion; and a second reference value that is the first pressure value when the fluctuation range of the second pressure value is within a predetermined range. an occupancy rate calculation unit that calculates an occupancy rate of the balloon portion with respect to the blood vessel corresponding to a first pressure value measured by the first optical sensor based on;
It may have.

With the above configuration, the variation range of the second pressure value is monitored, and when the variation range of the second pressure value falls within a predetermined range, the balloon portion is completely inflated to block the blood vessel. You can confirm that It is particularly useful when a balloon inserted from the patient's femoral artery is placed in the descending aorta; once the balloon is fully inflated and occludes the blood vessel, blood pressure fluctuations on the proximal side of the balloon become smaller. 2 By monitoring the variation range of the pressure value, the degree of expansion of the balloon portion can be confirmed. Further, for example, the occupancy rate of the balloon part with respect to the blood vessel when the measured value by the first optical sensor is the first reference value is 0%, and the occupancy rate of the balloon part with respect to the blood vessel when the measured value by the first optical sensor is the second reference value. By setting the occupancy rate of the balloon portion to 100%, the occupancy rate of the balloon portion corresponding to the measured value by the first optical sensor can be calculated as a specific numerical value.

The pressure measurement processing system according to the present invention has the above configuration, and includes a display device that displays visual information.
The display device may display the occupancy rate of the balloon section with respect to the blood vessel calculated by the occupancy rate calculation section.

With the above configuration, the practitioner can visually confirm the occupancy rate of the balloon portion with respect to the blood vessel. This allows the practitioner to grasp the degree of expansion of the balloon section, and to prevent over-expansion of the balloon section, which may cause blood vessel rupture, or rapid deflation of the balloon section, which may cause ischemia-reperfusion injury. In addition, expansion and contraction of the balloon portion can be appropriately controlled.

In the pressure measurement processing system according to the present invention, in the above configuration, the display device may display a graph of changes over time of the first pressure value and the second pressure value.

With the above configuration, the practitioner can visually check the change over time in the degree of expansion of the balloon portion.

1 is a diagram schematically showing a state in which the distal end side of a balloon catheter according to the present invention is inserted into a patient's body. FIG. 1 is a schematic cross-sectional view showing an example of a balloon catheter according to a first embodiment of the present invention. 3 is a partially enlarged sectional view of the vicinity of the distal tip of the balloon catheter shown in FIG. 2. FIG. 3 is a partially enlarged sectional view of the vicinity of the proximal end of the balloon portion of the balloon catheter shown in FIG. 2. FIG. FIG. 1 is a functional block diagram showing the configuration of a pressure measurement processing system according to a first embodiment of the present invention. It is a graph of changes over time of the first pressure value and the second pressure value measured by the balloon catheter in the first embodiment of the present invention. It is a figure showing an example of the display screen displayed on a display by the pressure measurement processing system in a 1st embodiment of the present invention. It is a schematic sectional view showing an example of a balloon catheter in a 2nd embodiment of the present invention. 9 is a partially enlarged sectional view of the vicinity of the distal tip of the balloon catheter shown in FIG. 8. FIG. 9 is a partially enlarged sectional view of the vicinity of the proximal end of the balloon portion of the balloon catheter shown in FIG. 8. FIG. It is a schematic sectional view showing an example of a balloon catheter in a 3rd embodiment of the present invention. 12 is a partially enlarged sectional view of the vicinity of the proximal end of the balloon portion of the balloon catheter shown in FIG. 11. FIG.

Embodiments of the present invention will be described below with reference to the drawings. In this specification, with reference to the practitioner who is the user of the balloon catheter according to the present invention, the inside of the patient's body is defined as the distal side, and the side near the practitioner's hand is defined as the proximal side. The drawings referred to in this specification are not necessarily to scale with respect to actual dimensions, and are partially exaggerated or simplified in order to schematically illustrate configurations according to the present invention.

The balloon catheter according to the present invention is provided with a balloon part that can be expanded and deflated on the distal end side, and is used to occlude the blood vessel by inserting the balloon part into the blood vessel and expanding the balloon part. It is a catheter that can be used.

As an example, as shown in FIG. 1, the balloon catheter 10 according to the present invention includes a balloon section 50 at the distal end of a long catheter tube 20, and the balloon section 50 is used for patients with heavy bleeding or for patients with heavy bleeding. It is inserted into the femoral artery from the base of the thigh of a patient who is at risk of bleeding and carried to the descending aorta, and the balloon portion 50 is expanded within the descending aorta to suppress blood flow to the lower limbs and prevent blood flow to the heart and brain. It can be used to maintain blood flow and maintain these functions. However, the blood vessel whose blood flow is to be suppressed using the balloon catheter 10 according to the present invention is not limited to the descending aorta, and the balloon catheter 10 according to the present invention can be applied to any blood vessel to suppress its blood flow. Furthermore, the position at which the distal end of the balloon catheter 10 is inserted into the body is not limited to the femoral artery, and the balloon portion 50 can be placed at a desired position within the blood vessel by approaching from various positions.

In the balloon catheter 10 according to the present invention, a first optical sensor 110 capable of measuring pressure using light is disposed on the distal side of the balloon section 50, and the first optical sensor 110 capable of measuring pressure using light is disposed on the distal side of the balloon section 50. A possible second optical sensor 120 is located proximal to the balloon portion 50 . As a result, the first optical sensor 110 independently measures the blood pressure in the blood vessel distal to the balloon part 50, and the second optical sensor 120 measures the blood pressure in the blood vessel proximal to the balloon part 50, respectively. It is configured in such a way that it is possible.

By using the first optical sensor 110 and the second optical sensor 120, which measure pressure using light, they are less susceptible to electrical noise, and can be used even when using a device that can generate an electric field, such as an electric scalpel. , blood pressure can be measured accurately and stably. Furthermore, since the first optical sensor 110 and the second optical sensor 120 have small fluctuations (drift) due to temperature changes or the passage of time, blood pressure can be measured accurately and stably even in an internal environment that can change over time. You will be able to do this.

Each of the embodiments described below specifically implements the above configuration, but the present invention is not limited to each of these embodiments.

<First embodiment>
A first embodiment of the present invention will be described below with reference to FIGS. 2 to 7.

FIG. 2 is a schematic cross-sectional view showing an example of the balloon catheter 10A according to the first embodiment of the present invention. As shown in FIG. 2, in the balloon catheter 10A in the first embodiment, a balloon part 50 is attached to the distal end of a long catheter tube 20A, and a branch part 80A is connected to the proximal end of the catheter tube 20A. It has been roughly configured. A balloon catheter 10A in the first embodiment corresponds to the balloon catheter 10 shown in FIG. 1, and a catheter tube 20A in the first embodiment corresponds to the catheter tube 20 shown in FIG.

The catheter tube 20A is an elongated member having a tubular structure and having a lumen formed in the axial direction. The catheter tube 20A is a single lumen type tube in which one lumen is formed.

The lumen of the catheter tube 20A communicates with the inside of the balloon part 50 via a pressure fluid inlet 21A that opens inside the balloon part 50, and allows pressurized fluid to flow in and out of the inside of the balloon part 50. It functions as a pressure fluid conduit 22A capable of That is, inside the catheter tube 20A, a fluid circulation lumen is formed in the axial direction, which has a communication port to the inside of the balloon part 50 and allows pressure fluid to flow therethrough. The pressure fluid communication port 21A in the first embodiment is the distal end opening of the catheter tube 20A. The pressure fluid guide path 22A of the catheter tube 20A also serves as an insertion path for the optical fiber 111 connected to the first optical sensor 110 and the optical fiber 121 connected to the second optical sensor 120.

The proximal end 50b of the balloon section 50 is connected to the distal end of the catheter tube 20A, and the distal end of the branch 80A is connected to the proximal end of the catheter tube 20A.

The catheter tube 20A is provided with a second sensor accommodating section 30A that accommodates the second optical sensor 120 on the proximal side of the joining position where the proximal end 50b of the balloon section 50 is joined. Details of the second sensor accommodating portion 30A will be described later.

The catheter tube 20A is made of synthetic resin such as polyurethane, polyvinyl chloride, polyethylene terephthalate, polyamide, etc., but is not particularly limited, and stainless steel wire or the like may be embedded therein. The inner diameter and wall thickness of the catheter tube 20A are not particularly limited, but the inner diameter is preferably 1.5 to 4.0 mm, and the wall thickness is preferably 0.05 to 0.4 mm. The length of the catheter tube 20A is also not particularly limited, but is preferably 300 to 800 mm.

Further, as the catheter tube 20A in the first embodiment, a tube whose inner lumen is formed offset from the axis as shown in FIG. 2 may be used. As will be described later, the second sensor accommodating portion 30A that accommodates the second optical sensor 120 forms an accommodating space 31A that opens to the outer peripheral surface of the catheter tube 20A. When using a catheter tube 20A in which the lumen is formed offset from the axis, the second light is applied to the thick part where the distance between the inner circumferential surface (the circumferential wall surface of the inner lumen) and the outer circumferential surface is relatively large. A housing space 31A that can accommodate the sensor 120 can be formed.

A guide wire tube 40A is inserted into the lumen of the catheter tube 20A. That is, the guide wire tube 40C is inserted into the fluid circulation lumen of the catheter tube 20C, and the catheter tube 20A is used as an outer tube, and the guide wire tube 40A is inserted inside the catheter tube 20A as an inner tube. The guide wire tube 40A is an elongated member with a tubular structure that extends in the axial direction inside the catheter tube 20A and the balloon section 50.

The inner circumferential surface of the catheter tube 20A and the outer circumferential surface of the guide wire tube 40A may be fixed partially or entirely in the axial direction with an adhesive or the like. By fixing the catheter tube 20A and the guide wire tube 40A, it is possible to reduce the flow resistance of the pressure fluid in the pressure fluid guide path 22A within the catheter tube 20A. The adhesive used for fixing is not particularly limited, and adhesives such as cyanoacrylate adhesives and epoxy adhesives can be used, and it is particularly preferable to use cyanoacrylate adhesives.

The lumen formed inside the guide wire tube 40A does not communicate with the inside of the balloon section 50 and the pressure fluid conduit 22A inside the catheter tube 20A, and guides the balloon section 50 to a predetermined position within the blood vessel. It functions as a guide wire passageway 41A through which a guide wire (not shown) used for this purpose can be inserted. That is, a guide wire insertion lumen is formed in the axial direction inside the guide wire tube 40A. The distal end of the guidewire tube 40A is attached to the proximal end of the distal tip 60A by means such as heat fusion or adhesive so that the internal guidewire passage 41A and the guidewire insertion hole 61A of the distal tip 60A communicate with each other. connected to the section. The proximal end of the guidewire tube 40A is connected to the branch 80A so as to communicate with a secondary port 82A of the branch 80A, which will be described later.

The outer diameter of the guide wire tube 40A is not particularly limited, but is preferably 0.5 to 1.5 mm, preferably 30 to 60% of the inner diameter of the catheter tube 20A. The outer diameter of the guide wire tube 40A is substantially the same along the axial direction. The guide wire tube 40A is made of, for example, a synthetic resin tube such as polyurethane, polyvinyl chloride, polyethylene, polyamide, polyether ether ketone (PEEK), a nickel titanium alloy thin tube, a stainless steel thin tube, or the like. Further, when the guide wire tube 40A is made of a synthetic resin tube, a stainless steel wire or the like may be buried therein.

A balloon portion 50 is attached to the distal end of the catheter tube 20A. The balloon portion 50 is configured to be expandable (inflatable) and deflated in a direction perpendicular to the axial direction of the catheter tube 20A. In use, the balloon section 50 is inserted in a deflated state and placed at a predetermined position within a blood vessel, and then expanded by allowing pressure fluid to flow into the inside of the balloon section 50, thereby expanding the distal side of the balloon section 50. It is possible to suppress blood flow between the proximal side and the proximal side.

The balloon portion 50 is composed of a thin film having a thickness of approximately 50 to 500 μm. The material of the thin film constituting the balloon portion 50 is not particularly limited, but is preferably a material with excellent elasticity, and is made of, for example, natural rubber, isoprene rubber, silicone rubber, polyurethane elastomer, or the like.

The outer diameter and length of the balloon portion 50 are determined according to the inner diameter of the blood vessel whose blood flow is to be suppressed by the balloon portion 50, and the like. The outer diameter of the balloon portion 50 when expanded is preferably 12 to 40 mm, and the length of the balloon portion 50 is preferably 30 to 90 mm.

The distal end 50a of the balloon part 50 is joined to the outer peripheral surface of the distal tip 60A, and the proximal end 50b of the balloon part 50 is joined to the outer peripheral surface of the distal end of the catheter tube 20A. . The balloon portion 50, the distal tip 60A, and the catheter tube 20A are joined by, for example, heat fusion or adhesion. A contrast marker made of a radiopaque metal ring or the like is placed on the outer peripheral surface of the distal end of the catheter tube 20A, and the proximal end 50b of the balloon portion 50 is placed on the outer peripheral surface of the catheter tube 20A and the contrast marker from above. may be joined.

The distal end 50a and the proximal end 50b of the balloon part 50 are arranged on the outer peripheral surface of the catheter tube 20A and the outer periphery of the distal tip 60A, respectively, so that the pressure fluid inside the balloon part 50 does not leak to the outside of the balloon part 50. connected to the surface. Therefore, the inside of the balloon portion 50 communicates only with the pressure fluid passage 22A formed inside the catheter tube 20A through the pressure fluid passage 21A, which is the opening at the distal end of the catheter tube 20A. Thereby, when the pressure fluid is introduced into and led out of the balloon part 50 through the pressure fluid communication port 21A, the balloon part 50 can be expanded and deflated.

The balloon portion 50 is inserted into a blood vessel in a deflated state. After the balloon portion 50 is placed at a predetermined position within the blood vessel, the balloon portion 50 is expanded by introducing pressure fluid into the inside.

The proximal end of the distal tip 60A is connected to the distal end of the guidewire tube 40A. The distal tip 60A is the most distal member of the balloon catheter 10A. The distal tip 60A has, for example, a cylindrical shape with a smooth curved surface or a tapered shape on the distal side so as not to damage the blood vessel wall etc. when inserted into the blood vessel.

A guide wire insertion hole 61A and a first sensor accommodating portion 70A are formed inside the distal tip 60A. The guide wire insertion hole 61A is a through hole that opens at the distal and proximal ends of the distal tip 60A and extends in the axial direction. For example, the opening at the proximal end of the guidewire insertion hole 61A (the proximal opening 63A shown in FIG. 3) is formed so that the guidewire tube 40A can be inserted therein, and the guidewire tube 40A is inserted into the proximal end opening (base opening 63A shown in FIG. 3). The tube 40A and the distal tip 60A can be connected.

In use, by inserting the guide wire into the guide wire passage 41A and the guide wire insertion hole 61A, the balloon portion 50 can be carried to a predetermined position in the body along the guide wire. The inner diameter of the guide wire insertion hole 61A may be any size as long as the guide wire can be inserted therethrough.

The distal end 50a of the balloon portion 50 is joined to the outer peripheral surface of the distal tip 60A. The connection between the balloon portion 50 and the distal tip 60A is performed by heat fusion, adhesion, or the like.

The tip tip 60A is provided with a first sensor accommodating section 70A that accommodates the first optical sensor 110 on the distal side of the joining position where the distal end 50a of the balloon section 50 is joined. The first sensor accommodating portion 70A is formed so as to be spaced apart from the guide wire insertion hole 61A. Details of the first sensor accommodating portion 70A will be described later.

Although the length and size of the distal tip 60A are not particularly limited, the length is about 10 to 30 mm, and the outer diameter is set to be about the same or smaller than the outer diameter of the catheter tube 20A, for example. Further, the material and forming method of the tip 60A are not particularly limited, and for example, it can be manufactured by injection molding using a synthetic resin material such as polyurethane, polyvinyl chloride, polyethylene terephthalate, or polyamide.

The balloon catheter 10A in the first embodiment includes a first optical sensor 110 disposed distal to the balloon part 50 and a second optical sensor 120 disposed proximal to the balloon part 50. .

The first optical sensor 110 is arranged in a first sensor accommodating portion 70A provided in the distal tip 60A. The first optical sensor 110 is an optical pressure sensor that can measure pressure using light, and can measure blood pressure on the proximal side of the balloon section 50.

As the first optical sensor 110 used in the first embodiment, an existing optical pressure sensor or the like that detects a change in pressure applied to a pressure receiving surface (pressure receiving diaphragm) as a change in the intensity of light transmitted through an optical fiber can be used. . The outer diameter of existing optical pressure sensors commonly used in this technical field is 0.1 to 0.5 mm. Note that an optical pressure sensor generally includes a sensor section having a pressure-receiving surface and an optical fiber that is integrally connected to the sensor section, but in this specification, the sensor section of the optical pressure sensor is will be referred to as a first optical sensor 110.

The first sensor accommodating portion 70A provided in the distal tip 60A forms an accommodating space 71A having a size capable of accommodating the first optical sensor 110, and also has a pressure sampling opening opened on the outer peripheral surface of the distal tip 60A. It has a section 72A.

A first optical sensor 110 is accommodated in the accommodation space 71A of the first sensor accommodation section 70A, and an optical fiber 111 integrated and connected to the first optical sensor 110 is inserted into the balloon section 50 through the proximal surface of the distal tip 60A. is being extended.

The pressure sampling opening 72A only needs to be opened so that the first optical sensor 110 can detect external pressure (that is, the blood pressure of blood flowing in the blood vessel), and its opening diameter is not particularly limited. It is preferable that the sensor 110 is formed in such a size or shape that it cannot pass through the pressure sampling opening 72A. Further, the opening position of the pressure sampling opening 72A may be any position where external pressure can be appropriately detected. Preferably, it is formed.

Note that, as will be described later with reference to FIG. 3, a through hole for passing the optical fiber 111 is formed between the housing space 71A of the first sensor housing section 70A and the proximal surface of the distal tip 60A. This through hole is closed with, for example, a curable resin 131 while the optical fiber 111 is passed through it. Thereby, the accommodation space 71A of the first sensor accommodation section 70A is substantially opened only by the pressure sampling opening 72A.

Further, as will be described later with reference to FIG. 3, in the accommodation space 71A of the first sensor accommodation section 70A, the pressure transmitting substance 132 is placed around the first optical sensor 110 while the first optical sensor 110 is accommodated therein. May be filled. The pressure transmitting substance 132 filled in the accommodation space 71A is in direct contact with the outside through the pressure sampling opening 72A, and can transmit external pressure applied to the pressure transmitting substance 132 to the first optical sensor 110.

The optical fiber 111 extending inside the balloon portion 50 through the proximal surface of the distal tip 60A further extends through the lumen (pressure fluid conduit 22A) of the catheter tube 20A. The proximal end of the optical fiber 111 is connected to a tertiary port 83A of a branch section 80A, which will be described later.

Inside the balloon portion 50, the optical fiber 111 is spirally wound around the outer peripheral surface of the guide wire tube 40A and extends in the axial direction of the guide wire tube 40A. As described above, when inserted into a blood vessel, the deflated balloon portion 50 is wound around the outer peripheral surface of the guide wire tube 40A. The guide wire tube 40A is wound around the outer peripheral surface of the guide wire tube 40A.

The optical fiber 111 extends in the axial direction of the catheter tube 20A in the inner lumen of the catheter tube 20A. A part of the outer circumferential surface or the entire axial direction of the optical fiber 111 may be fixed to the inner circumferential surface of the catheter tube 20A or the outer circumferential surface of the guide wire tube 40A with an adhesive or the like.

The second optical sensor 120 is arranged in a second sensor housing section 30A provided in the catheter tube 20A. The second optical sensor 120 is an optical pressure sensor that can measure pressure using light, and can measure blood pressure on the proximal side of the balloon section 50.

As the second optical sensor 120 used in the first embodiment, an existing optical pressure sensor or the like that detects a change in pressure applied to a pressure receiving surface (pressure receiving diaphragm) as a change in the intensity of light transmitted through an optical fiber can be used. . The outer diameter of existing optical pressure sensors commonly used in this technical field is 0.1 to 0.5 mm. The second optical sensor 120 may be of the same type as the first optical sensor 110 described above. Note that, similarly to the first optical sensor 110, the sensor section of the optical pressure sensor is referred to as a second optical sensor 120 in this specification.

The second sensor accommodating portion 30A provided in the catheter tube 20A forms an accommodating space 31A having a size capable of accommodating the second optical sensor 120, and also has a pressure sampling opening opened on the outer peripheral surface of the catheter tube 20A. It has a section 32A. Although the method of providing the second sensor accommodating portion 30A is not particularly limited, one example is a catheter tube 20A shown in FIG. The second sensor accommodating portion 30A including the accommodating space 31A in which the second optical sensor 120 can be accommodated can be formed in a thick portion where the distance between the peripheral wall surface of the second optical sensor 120 and the outer circumferential surface is relatively large.

A second optical sensor 120 is accommodated in the accommodation space 31A of the second sensor accommodation section 30A, and the optical fiber 121 integrated and connected to the second optical sensor 120 is inserted into the catheter tube 20A through the inner peripheral surface of the catheter tube 20A. The cavity (pressure fluid conduit 22A) is extended.

The pressure sampling opening 32A only needs to be opened so that the second optical sensor 120 can detect the external pressure (that is, the blood pressure of blood flowing in the blood vessel), and the opening diameter is not particularly limited. It is preferable that the sensor portion of the sensor 120 is formed in such a size or shape that it cannot pass through the pressure sampling opening. Further, the opening position of the pressure sampling opening 32A may be any position where external pressure can be detected. It is preferable that

Note that, as will be described later with reference to FIG. 4, a through hole for passing the optical fiber 121 is formed between the accommodation space 31A of the second sensor accommodation section 30A and the inner peripheral surface of the catheter tube 20A. This through hole is closed with, for example, a hardening resin 141 while the optical fiber 121 is passed through it. Thereby, the accommodation space 31A of the second sensor accommodation section 30A is substantially opened only by the pressure sampling opening 32A.

Further, as will be described later with reference to FIG. 4, in the accommodation space 31A of the second sensor accommodation section 30A, the pressure transmitting substance 142 is placed around the second optical sensor 120 in a state where the second optical sensor 120 is accommodated. May be filled. The pressure transmitting substance 142 filled in the accommodation space 31A is in direct contact with the outside through the pressure sampling opening 32A, and can transmit external pressure applied to the pressure transmitting substance 142 to the second optical sensor 120.

The optical fiber 121 that has entered the lumen of the catheter tube 20A through the inner peripheral surface of the catheter tube 20A extends in the axial direction of the lumen of the catheter tube 20A. The proximal end of the optical fiber 121 is connected to a tertiary port 83A of a branch section 80A, which will be described later.

The optical fiber 121 extends in the axial direction of the catheter tube 20A in the inner lumen of the catheter tube 20A. A part of the outer peripheral surface or the entire axial direction of the optical fiber 121 may be fixed to the inner peripheral surface of the catheter tube 20A or the outer peripheral surface of the guide wire tube 40A with an adhesive or the like.

A branch portion 80A is connected to the proximal end of the catheter tube 20A. The branch portion 80A is formed separately from the catheter tube 20A, and is connected to the catheter tube 20A by means of heat fusion, adhesion, or the like. The branch portion 80A includes a primary passage 84A that communicates with the pressure fluid conduction passage 22A and the primary port 81A in the catheter tube 20A, a secondary passage 85A that communicates with the guidewire passage 41A and the secondary port 82A in the guidewire tube 40A, A tertiary passage 86A is formed which communicates with the pressure fluid guide passage 22A through which the optical fibers 111 and 121 extend and with the tertiary port 83A.

The primary port 81A is configured so that a syringe or the like can be connected thereto, and pressure fluid can be introduced into and led out of the balloon portion 50 using the syringe or the like. The primary passage 84A extends linearly at the distal end of the branch 80A and is directly connected to the pressure fluid conduit 22A. Thereby, inside the pressure fluid conduit 22A, the flow path resistance of the pressure fluid introduced and led out via the primary port 81A is reduced. The pressure fluid is not particularly limited, but physiological saline is preferably used.

The secondary port 82A allows insertion of a guide wire (not shown). A secondary passage 85A communicating with the secondary port 82A extends linearly at the distal end of the branch portion 80A. At the distal end of the branch 80A, the secondary passage 85A is coupled to the proximal end of the guidewire tube 40A so as to communicate with the guidewire passage 41A. The guide wire inserted from the secondary port 82A passes through the secondary passage 85A and the guide wire passage 41A, and can be exposed to the outside from the guide wire insertion hole 61A of the distal tip 60A.

A tertiary passage 86A through which the optical fiber 121 is inserted communicates with the tertiary port 83A. The tertiary passage 86A communicates with the primary passage 84A, and the proximal ends of the optical fiber 111 connected to the first optical sensor 110 and the optical fiber 121 connected to the second optical sensor 120 are pulled out from the tertiary port 83A. It looks like this. The optical fibers 111 and 121 are adhesively fixed inside the tertiary passage 86A close to the outlet of the tertiary port 83A. The outlet of the optical fibers 111, 121 in the tertiary port 83A has a seal structure to prevent the pressure fluid flowing through the primary passage 84A from leaking to the outside.

An optical connector 150 is connected to the proximal ends of the optical fibers 111 and 121, and a pressure measurement processing device 200 (see FIG. 5), which will be described later, is connected to the optical connector 150. The pressure measurement processing device 200 is configured to perform processing related to the pressure detected by each of the first optical sensor 110 and the second optical sensor 120, as will be described later.

FIG. 3 is a partially enlarged sectional view of the vicinity of the distal tip 60A of the balloon catheter 10A shown in FIG.

As shown in FIG. 3, the distal end 50a of the balloon portion 50 is joined to the outer peripheral surface of the proximal end of the distal tip 60A. The guide wire insertion hole 61A formed inside the distal tip 60A has a distal opening 62A that opens at the distal end of the distal tip 60A and a proximal opening 63A that opens at the proximal surface of the distal tip 60A. A through hole extends in the axial direction between the holes. A distal end portion of the guide wire tube 40A is inserted into the proximal opening 63A, and the guide wire tube 40A and the distal tip 60A are connected. The guide wire insertion hole 61A of the distal tip 60A communicates with the guide wire passage 41A, which is the inner cavity of the guide wire tube 40A. A guide wire (not shown) inserted into the guide wire passage 41A can be inserted through the proximal opening 63A through the guide wire insertion hole 61A so as to be exposed to the outside of the distal opening 62A.

A first sensor accommodating portion 70A that accommodates the first optical sensor 110 is formed in the tip tip 60A. The first sensor accommodating portion 70A does not communicate with the guide wire insertion hole 61A and is separated from the guide wire insertion hole 61A. The first sensor accommodating portion 70A has an accommodating space 71A that accommodates the first optical sensor 110, and a pressure sampling opening 72A that opens the accommodating space 71A to the outside.

Although the position where the pressure sampling opening 72A is formed is not particularly limited, it is preferably formed distal to the joining position with the distal end 50a of the balloon part 50, for example, the opening is formed on the distal end side of the distal tip 60A. It is formed to Moreover, it is preferable that the opening diameter of the pressure sampling opening 72A is set to a size that does not allow the first optical sensor 110 to pass through. Thereby, even if, for example, the optical fiber 111 connected to the first optical sensor 110 is broken near the first optical sensor 110, the first optical sensor 110 is prevented from flowing out of the accommodation space 71A. be able to.

An optical fiber passage hole 73A communicating with the accommodation space 71A is formed in the distal tip 60A. The optical fiber through hole 73A has a proximal through hole opening 74A that opens so as to communicate with the inside of the balloon portion 50.

The optical fiber passage hole 73A is communicated with a curable resin filling hole extending toward the side of the distal tip 60A. The curable resin filling hole has filling hole openings 75A to 77A that communicate with the outside from the side peripheral surface of the distal tip 60A. Although three curable resin filling holes are formed along the axial direction of the tip 60A in FIG. 3, the number of curable resin filling holes is not particularly limited.

When arranging the first optical sensor 110 in the housing space 71A, first, the proximal end of the optical fiber 111 connected to the first optical sensor 110 is inserted through the pressure sampling opening 72A and into the optical fiber passage hole 73A. , is exposed from the through-hole opening 74A on the proximal side of the optical fiber through-hole 73A. Then, the optical fiber 111 is pushed forward and the proximal end of the optical fiber 111 is pulled out from the tertiary port 83A of the branch part 80A, and the first optical sensor 110 connected to the distal end of the first optical sensor 110 is inserted into the pressure sampling opening. It is placed in the accommodation space 71A through the section 72A.

Next, the curable resin 131 flows in from the filling hole openings 75A to 77A to fill the optical fiber passage hole 73A with the curable resin 131. Then, the curable resin 131 is cured, and the optical fiber 111 is fixed in the optical fiber passage hole 73A. The filling amount of the curable resin 131 is preferably adjusted to an amount that closes the optical fiber passage hole 73A, and is preferably adjusted to an amount that does not reach the first optical sensor 110 arranged in the accommodation space 71A. . Further, after filling the curable resin 131, the resin may be dripped into the through hole opening 74A and the filling hole openings 75A to 77A to form a resin film. Thereafter, the distal end portion 50a of the balloon portion 50 is joined to the outer peripheral surface of the distal tip 60A by means such as heat fusion or adhesion.

Examples of the curable resin 131 include moisture-curing adhesives such as cyanoacrylate adhesives, heat-curing adhesives such as one-component epoxy adhesives, and two-component mixed curing adhesives such as two-component epoxy adhesives. Mold adhesive can be used.

By closing the optical fiber passage hole 73A with the curable resin 131, the accommodation space 71A is substantially open only at the pressure sampling opening 72A. Next, the pressure transmitting substance 132 flows into the housing space 71A through the pressure sampling opening 72A, and the pressure transmitting substance 132 is filled around the first optical sensor 110 housed in the housing space 71A.

As the pressure transmitting substance 132, for example, a gel-like substance such as silicone gel, polyacrylamide gel, or polyethylene oxide gel, or an oil-like substance such as silicone oil can be used.

When filling the accommodation space 71A with the curable resin 131, it is preferable that no air remains in the accommodation space 71A (especially around the first optical sensor 110). For example, in addition to the pressure sampling opening 72A, a resin filling hole that opens the accommodation space 71A to the outside is provided, and the pressure transmitting substance 132 flows through the resin filling hole, and the air in the accommodation space 71A is discharged from the pressure sampling opening 72A. It may also be allowed to escape to the outside. When a resin filling hole is provided, pressure is released from the resin filling hole by filling the accommodation space 71A with the pressure transmitting substance 132 and then dropping resin into the opening of the resin filling hole to form a resin film. The transmission substance 132 may be prevented from flowing out.

In the above-described configuration, the optical fiber 111 is fixed by flowing the curable resin 131 through the filling hole openings 75A to 77A and curing it, and the accommodation space 71A is opened only through the pressure sampling opening 72A. Although the partition wall is formed using the curable resin 131, the method for fixing the optical fiber 111 and forming the partition wall in the housing space 71A is not limited to this method. For example, a partition material through which the optical fiber 111 can be inserted and fixed and which can seal the pressure transmitting substance 132 may be arranged in the optical fiber passage hole 73A. This partition material can be made of a resin material such as urethane, acrylic, silicone, or epoxy. Further, by using both the curable resin 131 and the partition wall material, the accommodation space 71A that accommodates the first optical sensor 110 may be opened to the outside only through the pressure sampling opening 72A.

FIG. 4 is a partially enlarged sectional view of the vicinity of the proximal end 50b of the balloon section 50 of the balloon catheter 10A shown in FIG.

As shown in FIG. 4, the proximal end 50b of the balloon portion 50 is joined to the outer peripheral surface of the distal end of the catheter tube 20A. The distal end opening of the catheter tube 20A opens inside the balloon section 50, and allows the pressure fluid flowing through the inner lumen of the catheter tube 20A as the pressure fluid guide path 22A to flow into and out of the balloon section 50. The pressure fluid communication port 21A functions as a pressure fluid communication port 21A.

A guide wire tube 40A is inserted into the lumen of the catheter tube 20A. The inner lumen of the guide wire tube 40A functions as a guide wire passageway 41A through which a guide wire (not shown) can be inserted. The guidewire tube 40A is exposed from the distal end opening of the catheter tube 20A, extends into the balloon portion 50, and is connected to the distal tip 60A as described above.

Optical fibers 111 and 121 are further inserted into the lumen of the catheter tube 20A. The optical fiber 111 is exposed from the distal end opening of the catheter tube 20A and extends into the balloon section 50, and is connected to the first optical sensor accommodated in the first sensor accommodating section 70A of the distal tip 60A as described above. 110. The optical fiber 121 is connected to a second optical sensor 120 housed in a second sensor housing section 30A formed at the distal end of the catheter tube 20A.

A second sensor accommodating portion 30A that accommodates the second optical sensor 120 is formed at the distal end of the catheter tube 20A. The second sensor accommodating portion 30A is separated from and does not communicate with the pressure fluid conduit 22A, which is the inner cavity of the catheter tube 20A. The second sensor accommodating portion 30A has an accommodating space 31A that accommodates the second optical sensor 120, and a pressure sampling opening 32A that opens the accommodating space 31A to the outside.

Although the position where the pressure sampling opening 32A is formed is not particularly limited, it is preferably formed proximal to the joining position with the proximal end 50b of the balloon part 50 and near the joining position. Further, the opening diameter of the pressure sampling opening 32A is preferably set to a size that does not allow the second optical sensor 120 to pass through. Thereby, even if, for example, the optical fiber 121 connected to the second optical sensor 120 is broken near the second optical sensor 120, the second optical sensor 120 is prevented from flowing out of the accommodation space 31A. be able to.

An optical fiber passage hole 33A communicating with the accommodation space 31A is formed in the catheter tube 20A. The optical fiber passage 33A has a passage opening 34A that opens to communicate with the inner lumen of the catheter tube 20A.

The optical fiber passage 33A has a filling hole opening 35A that opens on the outer peripheral surface of the catheter tube 20A, and a distal end opening 36A that opens at the distal end of the catheter tube 20A. Although one filling hole opening 35A is formed in FIG. 4, the number of filling hole openings 35A is not particularly limited. Further, the distal end opening 36A is provided to facilitate placement of the second optical sensor 120 in the accommodation space 31A, and the optical fiber passage hole 33A does not necessarily have the distal end opening 36A. There isn't.

When arranging the second optical sensor 120 in the accommodation space 31A, first, the proximal end of the optical fiber 111 connected to the second optical sensor 120 is connected to the optical fiber from the distal end opening 36A or the pressure sampling opening 32A. The optical fiber is inserted through the through hole 33A and into the inner lumen of the catheter tube 20A from the through hole opening 34A on the proximal side of the optical fiber through hole 33A. Then, the optical fiber 121 is pushed forward and the proximal end of the optical fiber 121 is pulled out from the tertiary port 83A of the branch part 80A, and the second optical sensor 120 connected to the distal end of the second optical sensor 120 is inserted into the distal end opening. 36A or the pressure sampling opening 32A and placed in the accommodation space 31A.

Next, the curable resin 141 flows in from the filling hole opening 35A to fill the proximal side of the optical fiber passage hole 33A with the curable resin 141. Then, the curable resin 141 is cured, and the optical fiber 121 is fixed in the optical fiber passage hole 33A. Thereby, the proximal side of the optical fiber passage hole 33A from the pressure sampling opening 32A is closed with the curable resin. The filling amount of the curable resin 141 is preferably adjusted to an amount that closes the proximal side of the optical fiber passage hole 33A, and is adjusted to an amount that does not reach the second optical sensor 120 disposed in the accommodation space 31A. It is preferable that

In addition, when the optical fiber passage hole 33A is open at the distal end opening 36A, the curable resin 141 is flowed from the distal end opening 36A to the distal side of the optical fiber passage hole 33A. The curable resin 141 is filled, and the curable resin 141 is cured. As a result, the distal side of the optical fiber passage hole 33A from the pressure sampling opening 32A is closed with the curable resin. The filling amount of the curable resin 141 is preferably adjusted to an amount that closes the distal side of the optical fiber passage hole 33A, and is adjusted to an amount that does not reach the second optical sensor 120 disposed in the accommodation space 31A. It is preferable that Alternatively, after filling the curable resin 141, the resin may be dripped into the distal end opening 36A and the filling hole opening 35A to form a resin film. Thereafter, the proximal end 50b of the balloon portion 50 is joined to the outer peripheral surface of the catheter tube 20A by means such as heat fusion or adhesion.

Examples of the curable resin 141 include moisture-curing adhesives such as cyanoacrylate adhesives, heat-curing adhesives such as one-component epoxy adhesives, and two-component mixed curing adhesives such as two-component epoxy adhesives. Mold adhesive can be used.

By closing the distal and proximal sides of the optical fiber passage hole 33A with the curable resin 141 across the pressure sampling opening 32A, the accommodation space 31A is substantially open only at the pressure sampling opening 32A. Next, the pressure transmitting substance 142 flows into the housing space 31A through the pressure sampling opening 32A, and the pressure transmitting substance 142 is filled around the second optical sensor 120 housed in the housing space 31A.

As the pressure transmitting substance 142, for example, a gel-like substance such as silicone gel, polyacrylamide gel, or polyethylene oxide gel, or an oil-like substance such as silicone oil can be used.

When filling the accommodation space 31A with the curable resin 141, it is preferable that no air remains in the accommodation space 31A (especially around the second optical sensor 120). For example, in addition to the pressure sampling opening 32A, a resin filling hole that opens the accommodation space 31A to the outside may be provided, and the pressure transmitting substance 142 may be introduced through the resin filling hole to drain the air in the accommodation space 31A from the pressure sampling opening 32A. It may also be allowed to escape to the outside. When a resin filling hole is provided, pressure is released from the resin filling hole by filling the accommodation space 31A with the pressure transmitting substance 142 and then dropping the resin into the opening of the resin filling hole to form a resin film. The transmission substance 142 may be prevented from flowing out.

Note that in the above-described configuration, the optical fiber 121 is fixed by inflowing and curing the curable resin 141 from the filling hole opening 35A and the distal end opening 36A, and the accommodation space 31A is connected to the pressure sampling opening 32A. Although the partition wall is formed of the curable resin 141 so as to open with a chisel, the method for fixing the optical fiber 121 and forming the partition wall in the accommodation space 31A is not limited to this method. For example, a partition material through which the optical fiber 121 can be inserted and fixed and which can seal the pressure transmitting substance 142 may be arranged in the optical fiber passage hole 33A. This partition material can be made of a resin material such as urethane, acrylic, silicone, or epoxy. Further, by using both the curable resin 141 and the partition wall material, the accommodation space 31A that accommodates the second optical sensor 120 may be opened to the outside only through the pressure sampling opening 32A.

As an example, as shown in FIG. 1, a balloon catheter 10A according to the first embodiment has a distal end portion including a balloon portion 50 inserted into the femoral artery from the base of the thigh, carried to the descending aorta, and transported into the descending aorta. By expanding the balloon portion 50, it can be used to suppress blood flow to the lower limb side, maintain blood flow to the heart and brain, and maintain these functions.

As described above, in the balloon catheter 10A in the first embodiment, the first optical sensor 110 capable of measuring pressure using light is disposed on the distal side of the balloon part 50, A second optical sensor 120 capable of measuring pressure is arranged proximal to the balloon section 50. For example, when the descending aorta is expanded by placing the balloon part 50 through the femoral artery approach as shown in FIG. A difference occurs between the blood pressure upstream and downstream of the balloon portion 50 of the aorta. The blood pressure upstream of the balloon part 50 of the descending aorta is measured by the first optical sensor 110, the blood pressure downstream of the balloon part 50 of the descending aorta is measured by the second optical sensor 120, and the blood pressure is measured by the first optical sensor 110. By referring to the results and the measurement results obtained by the second optical sensor 120, it is possible to monitor the degree of expansion of the balloon section 50 and the degree of occlusion of the blood vessel by the balloon section 50.

Note that, for example, a brachial artery approach can also be performed in which the distal end of the balloon catheter 10A is inserted from the brachial artery and the balloon portion 50 is placed in the descending aorta. In this case, contrary to the femoral artery approach, the blood pressure upstream of the balloon part 50 of the descending aorta is measured by the second optical sensor 120, and the blood pressure downstream of the balloon part 50 of the descending aorta is measured by the first optical sensor. 110, and similarly to the femoral artery approach, by referring to the measurement results by the first optical sensor 110 and the measurement results by the second optical sensor 120, the degree of expansion of the balloon part 50 and the balloon part 50 can be measured. The degree of occlusion of blood vessels can be monitored.

A configuration example of the pressure measurement processing system according to the first embodiment of the present invention will be described with reference to FIG. 5. FIG. 5 is a functional block diagram showing the configuration of the pressure measurement processing system in the first embodiment of the present invention. The pressure measurement processing system shown in FIG. 5 includes a pressure measurement processing device 200 and a display (display device) 250.

The pressure measurement processing device 200 includes an I/F (interface) 201, a pressure value calculation section 202, a fluctuation monitoring section 203, an occupancy rate calculation section 204, and a display output section 205. Pressure measurement processing device 200 can be realized by a computer equipped with a processor and memory. Examples of the processor include a CPU (Central Processing Unit), a DSP (Digital Signal Processor) that performs data processing specialized for a specific purpose, or a GPU (Graphics Processing Unit). ), or FPGA (Field Programmable Gate Array), which has a high degree of design freedom, can be used.

The I/F 201 is an interface connectable to the optical connector 150, and has a function of taking in optical signals including the measurement results of the first optical sensor 110 and the second optical sensor 120 of the balloon catheter 10A described above. The optical signals supplied from the first optical sensor 110 and the second optical sensor 120 include information regarding pressure, for example, as the intensity of light, and the pressure value can be specified from the optical signals. Note that, for example, an analog/digital converter, an amplifier that amplifies the amplitude of the optical signal, a filter that passes only a specific frequency component, etc. are used to supply a signal suitable for calculating the pressure value to the pressure measurement processing device 200. may be done.

The pressure value calculation unit 202 has a function of calculating the pressure values measured by the first optical sensor 110 and the second optical sensor 120 based on the optical signals transmitted from each sensor. Hereinafter, the upstream blood pressure measured by the first optical sensor 110 will be referred to as a first pressure value, and the downstream blood pressure measured by the second optical sensor 120 will be referred to as a second pressure value.

The fluctuation monitoring unit 203 monitors fluctuations in the upstream blood pressure (first pressure value) measured by the first optical sensor 110 and fluctuations in the downstream blood pressure (second pressure value) measured by the second optical sensor 120. It has a function to monitor.

The fluctuation monitoring section 203 is configured to monitor fluctuations in the second pressure value at which blood flow is suppressed when the balloon section 50 is expanded, for example, and when the fluctuation range of the second pressure value is within a predetermined range. It is configured to monitor whether there is a change. If the variation range of the second pressure value becomes smaller and changes within a predetermined range, it can be said that the blood flow has almost stopped and the variation of the second pressure value is no longer affected by pulsation, and the balloon This means that the portion 50 has completely expanded and the blood flow has been dammed. That is, by monitoring the variation range of the second pressure value by the variation monitoring unit 203, when the variation range of the second pressure value falls within a predetermined range, the balloon unit 50 is completely expanded and blocks the blood vessel. It can be determined that In particular, when the balloon part 50 is placed in the descending aorta by the femoral artery approach, when the balloon part 50 is completely expanded and blocks the blood vessel, blood pressure fluctuations become smaller on the proximal side of the balloon part 50, so that the second pressure By monitoring the variation range of the value, the degree of expansion of the balloon section 50 can be confirmed.

The occupancy rate calculation section 204 has a function of calculating the occupancy rate of the balloon section 50 with respect to the blood vessel. For example, the first pressure value before the balloon part 50 is inflated is the first reference value (the first pressure value when the balloon part 50 is not inflated at all), and the variation range of the second pressure value is within a predetermined range. The first pressure value at which the balloon part 50 is completely expanded is set as the second reference value (the first pressure value when the balloon part 50 is completely expanded). Then, the occupancy rate of the balloon part 50 with respect to the blood vessel when the first pressure value is the first reference value is set to 0%, and the occupancy rate of the balloon part 50 with respect to the blood vessel when the first pressure value is the second reference value is set as 0%. By drawing a calibration curve assuming 100%, the occupancy rate of the balloon section 50 corresponding to the first pressure value can be calculated as a specific numerical value.

The display output unit 205 processes the first pressure value and second pressure value calculated by the pressure value calculation unit 202, the occupancy rate calculated by the occupancy rate calculation unit 204, etc. into visual information (image information or video information). , has a function of outputting it so that it can be displayed on the display 250. For example, the first pressure value and the second pressure value calculated by the pressure value calculation unit 202 may be displayed on the display 250 as a graph showing changes over time. Further, the occupancy rate calculated by the occupancy rate calculation unit 204 may be displayed on the display 250 using specific numerical values, images, or the like.

Here, with reference to FIG. 6, the upstream blood pressure (first pressure value) measured by the first optical sensor 110 and the downstream blood pressure (second pressure value) measured by the second optical sensor 120. The relationship between the variation in the amount and the degree of expansion of the balloon portion 50 will be explained. FIG. 6 is a graph of changes over time of the first pressure value and the second pressure value measured by the balloon catheter 10A in the first embodiment of the present invention. In the graph shown in FIG. 6, the horizontal axis represents measurement time [s], and the vertical axis represents pressure value [mmHg]. Further, FIG. 6 schematically depicts the size (cross section) of the balloon portion 50 inside the blood vessel at a specific measurement time.

Before the measurement time of 15 seconds, the balloon section 50 has not yet been expanded. At this time, the first pressure value measured by the first optical sensor 110 and the second pressure value measured by the second optical sensor 120 are approximately the same. Further, both the first pressure value and the second pressure value fluctuate due to pulsation.

In the graph shown in FIG. 6, the maximum value of the amplitude of the first pressure value is about 20 [mmHg]. The occupancy rate calculation unit 204 stores the first pressure value at this time as a first reference value. When the first pressure value is the first reference value, the occupation rate of the balloon section 50 with respect to the blood vessel is set to 0%.

During the measurement time of 15 to 20 seconds, pressure fluid is introduced into the inside of the balloon section 50 to completely expand the balloon section 50. At this time, the first pressure value measured by the first optical sensor 110 increases rapidly. On the other hand, when the balloon portion 50 is completely inflated, the second pressure value is no longer influenced by pulsation because the blood flow is dammed up, and thus the second pressure value hardly fluctuates and falls within a predetermined range. In this way, when the fluctuation in the second pressure value falls within a predetermined range in which it can be said that it is no longer affected by pulsation, it can be determined that the balloon portion 50 is completely expanded.

During the measurement time of 20 to 40 seconds, the balloon portion 50 remains fully expanded. At this time, the first pressure value measured by the first optical sensor 110 is a relatively high pressure value that fluctuates due to pulsation. On the other hand, the second pressure value is relatively low and remains almost unchanged.

In the graph shown in FIG. 6, the maximum value of the amplitude of the first pressure value fluctuates to reach about 150 [mmHg]. On the other hand, the second pressure value remains approximately 10 [mmHg] and does not substantially change. The occupancy rate calculation unit 204 stores the first pressure value at this time as a second reference value. When the first pressure value is the second reference value, the occupancy rate of the balloon section 50 with respect to the blood vessel is assumed to be 100%. In this way, the first reference value (occupancy rate 0%) and the second reference value (occupancy rate 100%) are specified for the first pressure value, and a calibration curve is created between the first reference value and the second reference value. By subtracting, the occupancy rate corresponding to an arbitrary first pressure value can be calculated as a specific numerical value.

During the measurement time of 45 to 70 seconds, the balloon portion 50 is deflated in stages. At this time, the first pressure value measured by the first optical sensor 110 becomes lower as the balloon part 50 contracts.

After the measurement time of 70 seconds, the balloon part 50 is kept in a completely deflated state. At this time, the first pressure value measured by the first optical sensor 110 and the second pressure value measured by the second optical sensor 120 are almost the same, and the pulsating It varies depending on.

The display screen displayed on the display 250 by the pressure measurement processing system in the first embodiment will be described below. FIG. 7 is a diagram showing an example of a display screen displayed on the display 250 by the pressure measurement processing system according to the first embodiment of the present invention.

As shown in FIG. 7, the display screen displayed on the display 250 displays a graph of changes over time in the first pressure value and the second pressure value, and the occupancy rate of the balloon section 50 with respect to the blood vessel.

For example, a graph display area 251, an occupancy rate display area 252, and a blood pressure value display area 253 are set on the display screen. In the graph display area 251, a temporal change graph as shown in FIG. 7 is displayed. The display of the graph of changes over time is preferably updated in real time at predetermined update intervals. Further, in the occupancy display area 252, the occupancy rate of the balloon section 50 with respect to the blood vessel calculated by the occupancy calculation section 254 based on the first pressure value is displayed as a specific numerical value. The display of the occupancy rate is preferably updated in real time at predetermined update intervals in response to changes in the first pressure value. Furthermore, as shown in FIG. 7, the occupancy rate of the balloon section 50 with respect to the blood vessel may be displayed, for example, as an image showing the size (cross section) of the balloon section 50 inside the blood vessel. Further, in the blood pressure value display area 253, as shown in FIG. 7, the average blood pressure on the front end of the balloon and the average blood pressure on the rear end of the balloon are displayed as specific numerical values. The average blood pressure at the tip of the balloon is the average value of the first pressure values in the most recent predetermined time range that is set to include at least one pulsation cycle, and the average blood pressure at the back end of the balloon is the average value of the first pressure values in the most recent predetermined time range that is set to include at least one pulsation cycle. This is the average value of the second pressure values in the most recent predetermined time range.

The practitioner performing the treatment using the balloon catheter 10A can visually confirm the occupancy rate of the balloon section 50 with respect to the blood vessel as a specific numerical value by visually checking the occupancy display area 252 on this display screen. I can do it. This allows the practitioner to grasp the degree of expansion of the balloon section 50, and prevents over-expansion of the balloon section 50, which may cause blood vessel rupture, or sudden contraction of the balloon section 50, which may cause ischemia-reperfusion injury. It becomes possible to appropriately control the expansion and contraction of the balloon section 50 so that this does not occur. In addition, the practitioner can visually check the temporal change in the degree of expansion of the balloon portion 50 using the temporal change graph.

<Second embodiment>
A second embodiment of the present invention will be described below with reference to FIGS. 8 to 10. In addition, below, while attaching the same code|symbol about the same component as 1st Embodiment mentioned above, the description may be abbreviate|omitted or simplified.

FIG. 8 is a schematic cross-sectional view showing an example of a balloon catheter 10B according to the second embodiment of the present invention. As shown in FIG. 8, in a balloon catheter 10B according to the second embodiment, a balloon part 50 is attached to the distal end of a long catheter tube 20B, and a branch part 80B is connected to the proximal end of the catheter tube 20B. It has been roughly configured. A balloon catheter 10B in the second embodiment corresponds to the balloon catheter 10 shown in FIG. 1, and a catheter tube 20B in the second embodiment corresponds to the catheter tube 20 shown in FIG.

The catheter tube 20B is an elongated member having a tubular structure and having a lumen formed along the axial direction inside the catheter tube 20B. Catheter tube 20B is a double lumen type tube in which two lumens are formed.

One of the two lumens (first lumen) formed in the catheter tube 20B communicates with the inside of the balloon part 50 via a pressure fluid communication port 21B that opens inside the balloon part 50. It functions as a pressure fluid introduction path 22B that allows pressure fluid to flow in and out of the inside of the balloon portion 50. That is, inside the catheter tube 20B, a fluid circulation lumen is formed in the axial direction, which has a communication port to the inside of the balloon portion 50 and allows pressure fluid to flow therethrough. The pressure fluid communication port 21B is formed inside the balloon portion 50 so as to open the pressure fluid communication path 22B.

The distal end opening of the first lumen functioning as the pressure fluid conduit 22B of the catheter tube 20B is closed by any means, so that the pressure fluid does not flow out from the distal end opening. It is configured so that it can flow into the inside of the balloon part 50 only through the conduction port 21B.

In the second embodiment, catheter tube 20B extends inside balloon section 50, and its distal end is connected to distal tip 60B. As will be described later, the distal end opening of the first lumen functioning as the pressure fluid conduit 22B of the catheter tube 20B is connected to the distal tip 60B and is closed. Further, the first lumen of the catheter tube 20B also serves as an insertion path for the optical fiber 111 connected to the first optical sensor 110 disposed within the distal tip 60B.

The second lumen of the catheter tube 20B is a sensor housing cavity 23B used to provide a second sensor housing part 30B in which the second optical sensor 120 is disposed, and an optical fiber connected to the second optical sensor 120. It also has the role of an insertion path for 121. A second sensor accommodating portion 30B is provided in the second lumen of the catheter tube 20B on the proximal side of the joining position where the proximal end portion 50b of the balloon portion 50 is joined. Details of the second sensor accommodating portion 30B will be described later.

Although not particularly limited, the catheter tube 20B is made of synthetic resin such as polyurethane, polyvinyl chloride, polyethylene terephthalate, polyamide, etc., and stainless steel wire or the like may be embedded therein. The inner diameter and wall thickness of the first and second lumens of the catheter tube 20B are not particularly limited, but the inner diameter of the second lumen is large enough to accommodate the second optical sensor 120 through it. It is preferable that there be. Further, it is preferable to ensure the flow rate of the pressure fluid in the first lumen functioning as the pressure fluid introduction path 22B, and it is preferable that the inner diameter of the first lumen is larger than the inner diameter of the second lumen. The length of the catheter tube 20B is also not particularly limited, but is preferably 300 to 800 mm.

A balloon portion 50 is attached to the distal end of the catheter tube 20B. The balloon portion 50 is configured to be expandable (inflatable) and deflated in a direction perpendicular to the axial direction of the catheter tube 20B. In use, the balloon section 50 is inserted in a deflated state and placed at a predetermined position within a blood vessel, and then expanded by allowing pressure fluid to flow into the inside of the balloon section 50, thereby expanding the distal side of the balloon section 50. It is possible to suppress blood flow between the proximal side and the proximal side.

The balloon portion 50 is composed of a thin film having a thickness of approximately 50 to 500 μm. The material of the thin film constituting the balloon portion 50 is not particularly limited, but is preferably a material with excellent elasticity, and is made of, for example, natural rubber, isoprene rubber, silicone rubber, polyurethane elastomer, or the like.

The outer diameter and length of the balloon portion 50 are determined according to the inner diameter of the blood vessel whose blood flow is to be suppressed by the balloon portion 50, and the like. The outer diameter of the balloon portion 50 when expanded is preferably 12 to 40 mm, and the length of the balloon portion 50 is preferably 30 to 90 mm.

The distal end 50a of the balloon section 50 is joined to the outer peripheral surface of the distal tip 60B, and the proximal end 50b of the balloon section 50 is joined to the outer peripheral surface of the distal end of the catheter tube 20B. . The balloon portion 50, the distal tip 60B, and the catheter tube 20B are joined by, for example, heat fusion or adhesion. A contrast marker made of a radiopaque metal ring or the like is arranged on the outer peripheral surface of the distal end of the catheter tube 20B, and the proximal end 50b of the balloon part 50 is placed on the outer peripheral surface of the catheter tube 20B and the contrast marker from above. may be joined.

The distal end 50a and the proximal end 50b of the balloon part 50 are arranged on the outer peripheral surface of the catheter tube 20B and the outer periphery of the distal tip 60B, respectively, so that the pressure fluid inside the balloon part 50 does not leak to the outside of the balloon part 50. connected to the surface. Therefore, the inside of the balloon portion 50 communicates only with the pressure fluid passage 22B formed inside the catheter tube 20B through the pressure fluid passage 21B of the catheter tube 20B. Thereby, when the pressure fluid is introduced into and led out of the balloon section 50 through the pressure fluid communication port 21B, the balloon section 50 can be expanded and contracted.

The balloon portion 50 is inserted into a blood vessel in a deflated state. After the balloon portion 50 is placed at a predetermined position within the blood vessel, the balloon portion 50 is expanded by introducing pressure fluid into the inside.

A proximal end of a distal tip 60B is connected to a distal end of the catheter tube 20B. The distal tip 60B is the most distal member of the balloon catheter 10B. The distal tip 60B has, for example, a cylindrical shape with a smooth curved surface or a tapered shape on the distal side so as not to damage the blood vessel wall etc. when inserted into the blood vessel.

Note that, unlike the balloon catheter 10B of the first embodiment, the balloon catheter 10B of the second embodiment is not provided with a guide wire tube. In the first embodiment, the distal tip 60A is connected to the guide wire tube 40A, whereas in the second embodiment, the distal tip 60B is connected to the catheter tube 20B.

The proximal end of the distal tip 60B is formed to be able to fit into the first lumen of the catheter tube 20B, for example, and the catheter tube 20B and the distal tip 60B can be connected by means such as heat fusion or adhesion. It looks like this.

A guide wire insertion hole 61B and a first sensor accommodating portion 70B are formed inside the distal tip 60B.

The guide wire insertion hole 61B is a through hole that opens at the distal end and side peripheral surface of the distal tip 60B. In use, by inserting a guide wire (not shown) into the guide wire insertion hole 61B, the balloon portion 50 can be carried into a predetermined position inside the body along the guide wire. The inner diameter of the guide wire insertion hole 61B may be any size as long as the guide wire can be inserted therethrough.

The distal end 50a of the balloon portion 50 is joined to the outer peripheral surface of the distal tip 60B. The balloon portion 50 and the distal tip 60B are connected by heat fusion, adhesion, or the like.

The tip tip 60B is provided with a first sensor accommodating portion 70B that accommodates the first optical sensor 110 on the distal side of the joining position where the distal end portion 50a of the balloon portion 50 is joined. The first sensor accommodating portion 70B is formed so as to be separated from the guide wire insertion hole 61B. Details of the first sensor housing section 70B will be described later.

Although the length and size of the distal tip 60B are not particularly limited, it is preferable that the length is about 10 to 30 mm, and the outer diameter is about the same or smaller than the outer diameter of the catheter tube 20B. Further, the material and forming method of the tip 60B are not particularly limited, and for example, it can be manufactured by injection molding using a synthetic resin material such as polyurethane, polyvinyl chloride, polyethylene terephthalate, or polyamide.

The balloon catheter 10B in the second embodiment includes a first optical sensor 110 disposed distal to the balloon portion 50 and a second optical sensor 120 disposed proximal to the balloon portion 50. . The first optical sensor 110 and the second optical sensor 120 can be the same as those in the first embodiment described above.

The first optical sensor 110 is arranged in a first sensor accommodating portion 70B provided in the distal tip 60B. The first optical sensor 110 is an optical pressure sensor that can measure pressure using light, and can measure blood pressure on the proximal side of the balloon section 50.

The first sensor accommodating portion 70B provided in the distal tip 60B forms an accommodating space 71B having a size capable of accommodating the first optical sensor 110, and also has a pressure sampling opening opened on the outer peripheral surface of the distal tip 60B. It has a section 72B.

The first optical sensor 110 is accommodated in the accommodation space 71B of the first sensor accommodation section 70B, and the optical fiber 111 integrated and connected to the first optical sensor 110 is inserted into the first optical fiber 111 of the catheter tube 20B through the proximal surface of the distal tip 60B. 1 lumen (pressure fluid conduit 22B).

The pressure sampling opening 72B only needs to be opened so that the first optical sensor 110 can detect external pressure (that is, the blood pressure of blood flowing in the blood vessel), and its opening diameter is not particularly limited. It is preferable that the sensor 110 is formed in such a size or shape that it cannot pass through the pressure sampling opening 72B. Further, the opening position of the pressure sampling opening 72B may be any position where external pressure can be appropriately detected. Preferably, it is formed.

Note that, as will be described later with reference to FIG. 9, a through hole for passing the optical fiber 111 is formed between the housing space 71B of the first sensor housing section 70B and the proximal surface of the distal tip 60B. This through hole is closed with, for example, a curable resin 131 while the optical fiber 111 is passed through it. Thereby, the accommodation space 71B of the first sensor accommodation part 70B is substantially opened only by the pressure sampling opening 72B.

Further, as will be described later with reference to FIG. 9, the accommodation space 71B of the first sensor accommodation part 70B is filled with a pressure transmitting substance 132 around the first optical sensor 110 in a state where the first optical sensor 110 is accommodated. may be done. The pressure transmitting substance 132 filled in the accommodation space 71B can directly contact the outside through the pressure sampling opening 72B, and can transmit external pressure applied to the pressure transmitting substance 132 to the first optical sensor 110.

The proximal end of the optical fiber 111 that extends axially through the first lumen (pressure fluid conduit 22B) of the catheter tube 20B through the proximal surface of the distal tip 60B is connected to the secondary port 82B of the branch section 80B, which will be described later. It is connected.

The optical fiber 111 extends in the axial direction of the catheter tube 20B in the first lumen of the catheter tube 20B. A part of the outer peripheral surface or the entire axial direction of the optical fiber 111 may be fixed to the inner peripheral surface of the catheter tube 20B with an adhesive or the like.

The second optical sensor 120 is arranged in a second sensor housing part 30B provided in the catheter tube 20B. The second optical sensor 120 is an optical pressure sensor that can measure pressure using light, and can measure blood pressure on the proximal side of the balloon section 50.

The second sensor accommodating portion 30B provided in the catheter tube 20B forms an accommodating space 31B large enough to accommodate the second optical sensor 120, and also has a pressure sampling opening opened on the outer peripheral surface of the catheter tube 20B. It has a section 32B. In the second embodiment, the second sensor housing portion 30B is formed using a part of the second lumen of the catheter tube 20B.

A second optical sensor 120 is accommodated in the accommodation space 31B of the second sensor accommodation section 30B, and an optical fiber 121 integrated and connected to the second optical sensor 120 extends through the second lumen of the catheter tube 20B. .

The pressure sampling opening 32B only needs to be opened so that the second optical sensor 120 can detect the external pressure (that is, the blood pressure of blood flowing in the blood vessel), and the opening diameter is not particularly limited. It is preferable that the sensor portion of the sensor 120 is formed in such a size or shape that it cannot pass through the pressure sampling opening. Further, the opening position of the pressure sampling opening 32B may be any position where external pressure can be detected. It is preferable that

As will be described later with reference to FIG. 10, the second lumen of the catheter tube 20B is used as a through hole for the optical fiber 121. It is blocked by 141 etc. Thereby, the accommodation space 31B of the second sensor accommodation part 30B is substantially opened only by the pressure sampling opening 32B.

Further, as will be described later with reference to FIG. 10, in the housing space 31B of the second sensor housing section 30B, the pressure transmitting substance 142 is placed around the second optical sensor 120 while the second optical sensor 120 is accommodated therein. May be filled. The pressure transmitting substance 142 filled in the accommodation space 31B can directly contact the outside through the pressure sampling opening 32B, and can transmit external pressure applied to the pressure transmitting substance 142 to the second optical sensor 120.

A proximal end portion of the optical fiber 121 extending in the axial direction through the second lumen of the catheter tube 20B is connected to a secondary port 82B of the branch portion 80B, which will be described later.

The optical fiber 121 extends in the axial direction of the catheter tube 20B in the second lumen of the catheter tube 20B. A part of the outer peripheral surface or the entire axial direction of the optical fiber 121 may be fixed to the inner peripheral surface of the catheter tube 20B with an adhesive or the like.

A branch portion 80B is connected to the proximal end of the catheter tube 20B. The branch portion 80B is formed separately from the catheter tube 20B, and is connected to the catheter tube 20B by means of heat fusion, adhesion, or the like. The branch portion 80B includes a primary passage 84B communicating with the pressure fluid conduit 22B and the primary port 81B in the catheter tube 20B, a secondary passage 84B communicating with the pressure fluid conduit 22B through which the optical fibers 111 and 121 extend, and the secondary port 82B. A passage 85B is formed.

The primary port 81B is configured so that a syringe or the like can be connected thereto, and pressure fluid can be introduced into and led out of the balloon portion 50 using the syringe or the like. The primary passage 84B extends linearly at the distal end of the branch 80B and is connected straight to the pressure fluid conduit 22B. Thereby, inside the pressure fluid conduit 22B, the flow path resistance of the pressure fluid introduced and led out via the primary port 81B is reduced.

Note that the second lumen of the catheter tube 20B may be closed with the optical fiber 121 passed through it near the proximal end of the catheter tube 20B so that the pressure fluid does not flow within the second lumen. . The pressure fluid is not particularly limited, but physiological saline is preferably used.

A secondary passage 85B through which the optical fiber 121 is inserted is communicated with the secondary port 82B. The secondary passage 85B communicates with the primary passage 84B, and from the secondary port 82B, the respective proximal ends of the optical fiber 111 connected to the first optical sensor 110 and the optical fiber 121 connected to the second optical sensor 120 are connected. It is designed to be pulled out. The optical fibers 111 and 121 are adhesively fixed inside the secondary passage 85B close to the outlet of the secondary port 82B. The outlet of the optical fibers 111, 121 in the secondary port 82B has a seal structure to prevent the pressure fluid flowing through the primary passage 84B from leaking to the outside.

An optical connector 150 is connected to the proximal ends of the optical fibers 111 and 121, and the above-described pressure measurement processing device 200 (see FIG. 5) is connected to the optical connector 150. As described above, the pressure measurement processing device 200 is configured to perform processing related to the pressure detected by each of the first optical sensor 110 and the second optical sensor 120.

FIG. 9 is a partially enlarged sectional view of the vicinity of the distal tip 60B of the balloon catheter 10B shown in FIG.

As shown in FIG. 9, the distal end 50a of the balloon portion 50 is joined to the outer peripheral surface of the proximal end of the distal tip 60B. As an example, as shown in FIG. 9, a fitting protrusion 65B that can be fitted into the first lumen of the catheter tube 20B is provided at the proximal end of the distal tip 60B. The fitting protrusion 65B can be inserted into and connected. Note that the proximal end of the distal tip 60B may be further shaped so that it can be fitted into the second lumen of the catheter tube 20B. Further, the second lumen of the catheter tube 20B may have its distal end closed with resin or the like.

A guide wire insertion hole 61B is formed in the distal tip 60B. The guide wire insertion hole 61B is a through hole extending between a distal opening 62B that opens at the distal end of the distal tip 60B and a side opening 63B that opens at the side surface of the distal tip 60B. A guide wire (not shown) can be inserted through the side opening 63B through the guide wire insertion hole 61B so as to be exposed to the outside of the tip opening 62B.

A first sensor accommodating portion 70B that accommodates the first optical sensor 110 is formed in the tip tip 60B. The first sensor accommodating portion 70B does not communicate with the guide wire insertion hole 61B and is separated from the guide wire insertion hole 61B. The first sensor accommodating portion 70B has an accommodating space 71B that accommodates the first optical sensor 110, and a pressure sampling opening 72B that opens the accommodating space 71B to the outside.

The position where the pressure sampling opening 72B is formed is not particularly limited, but it is preferably formed distally from the joining position with the distal end 50a of the balloon part 50, for example, the opening is formed on the distal end side of the distal tip 60B. It is formed to Further, the opening diameter of the pressure sampling opening 72B is preferably set to a size that does not allow the first optical sensor 110 to pass through. This prevents the first optical sensor 110 from flowing out of the housing space 71B even if, for example, the optical fiber 111 connected to the first optical sensor 110 breaks near the first optical sensor 110. be able to.

An optical fiber passage hole 73B communicating with the accommodation space 71B is formed in the distal tip 60B. The optical fiber through hole 73B has a proximal through hole opening 74B that opens so as to communicate with the inside of the balloon portion 50.

The optical fiber passage hole 73B communicates with a curable resin-filled hole that extends toward the side of the distal tip 60B. The curable resin filling hole has filling hole openings 75B and 76B that communicate with the outside from the side peripheral surface of the distal tip 60B. In addition, although two curable resin filling holes are formed along the axial direction of the distal tip 60B in FIG. 9, the number of curable resin filling holes is not particularly limited.

When arranging the first optical sensor 110 in the housing space 71B, first, the proximal end of the optical fiber 111 connected to the first optical sensor 110 is inserted through the pressure sampling opening 72B and into the optical fiber passage hole 73B. , is exposed from the through-hole opening 74B on the proximal side of the optical fiber through-hole 73B. Then, the optical fiber 111 is pushed forward and the proximal end of the optical fiber 111 is pulled out from the secondary port 82B of the branch part 80B, and the first optical sensor 110 connected to the distal end of the first optical sensor 110 is It is placed in the accommodation space 71B through the opening 72B.

Next, the curable resin 131 flows in from the filling hole openings 75B and 76B to fill the optical fiber passage hole 73B with the curable resin 131. Then, the curable resin 131 is cured, and the optical fiber 111 is fixed in the optical fiber passage hole 73B. The filling amount of the curable resin 131 is preferably adjusted to an amount that closes the optical fiber passage hole 73B, and is preferably adjusted to an amount that does not reach the first optical sensor 110 disposed in the accommodation space 71B. . Alternatively, after filling the curable resin 131, the resin may be dripped into the through hole opening 74B and the filling hole openings 75B and 76B to form a resin film. Thereafter, the distal end 50a of the balloon portion 50 is joined to the outer circumferential surface of the distal tip 60B by means such as heat fusion or adhesion.

Examples of the curable resin 131 include moisture-curing adhesives such as cyanoacrylate adhesives, heat-curing adhesives such as one-component epoxy adhesives, and two-component mixed curing adhesives such as two-component epoxy adhesives. Mold adhesive can be used.

By closing the optical fiber passage hole 73B with the curable resin 131, the housing space 71B is substantially opened only at the pressure sampling opening 72B. Next, the pressure transmitting substance 132 flows into the housing space 71B through the pressure sampling opening 72B, and the pressure transmitting substance 132 is filled around the first optical sensor 110 housed in the housing space 71B.

As the pressure transmitting substance 132, for example, a gel-like substance such as silicone gel, polyacrylamide gel, or polyethylene oxide gel, or an oil-like substance such as silicone oil can be used.

When filling the accommodation space 71B with the curable resin 131, it is preferable that no air remains in the accommodation space 71B (especially around the first optical sensor 110). For example, in addition to the pressure sampling opening 72B, a resin filling hole that opens the housing space 71B to the outside may be provided, and the pressure transmitting substance 132 may flow through the resin filling hole to drain the air in the housing space 71B from the pressure sampling opening 72B. It may also be allowed to escape to the outside. When a resin filling hole is provided, pressure is released from the resin filling hole by filling the accommodation space 71B with the pressure transmitting substance 132 and then dropping the resin into the opening of the resin filling hole to form a resin film. The transmission substance 132 may be prevented from flowing out.

Note that in the above-described configuration, the optical fiber 111 is fixed by flowing the curable resin 131 through the filling hole openings 75B and 76B and curing it, and the accommodation space 71B is opened only by the pressure sampling opening 72B. Although the partition walls are formed using the curable resin 131, the method for fixing the optical fibers 111 and forming the partition walls in the housing space 71B is not limited to this method. For example, a partition material through which the optical fiber 111 can be inserted and fixed and which can seal the pressure transmitting substance 132 may be arranged in the optical fiber passage hole 73B. This partition material can be made of a resin material such as urethane, acrylic, silicone, or epoxy. Further, by using both the curable resin 131 and the partition wall material, the accommodation space 71B that accommodates the first optical sensor 110 may be opened to the outside only through the pressure sampling opening 72B.

FIG. 10 is a partially enlarged sectional view of the vicinity of the proximal end 50b of the balloon portion 50 of the balloon catheter 10B shown in FIG.

As shown in FIG. 10, the proximal end 50b of the balloon portion 50 is joined to the outer peripheral surface of the distal end of the catheter tube 20B. Catheter tube 20B extends inside balloon section 50. As described above, the distal end of the catheter tube 20B is connected to the distal tip 60B, and the first lumen functioning as the pressure fluid conduit 22B is the pressure fluid conduit 21B located inside the balloon portion 50. It's open.

An optical fiber 111 is further inserted into the first lumen of the catheter tube 20B. The optical fiber 111 extends through the first lumen of the catheter tube 20B and is connected to the distal tip 60B through the optical fiber passage 73B in the distal tip 60B connected to the distal end of the catheter tube 20B, as described above. It is connected to the first optical sensor 110 accommodated in the first sensor accommodating section 70B.

An optical fiber 121 is inserted into the second lumen of the catheter tube 20B. The optical fiber 121 is connected to a second optical sensor 120 housed in a second sensor housing section 30B formed at the distal end of the catheter tube 20B.

A second sensor accommodating portion 30B that accommodates the second optical sensor 120 is formed at the distal end of the catheter tube 20B. The second sensor accommodating portion 30B is provided in the second lumen, which is the sensor accommodating cavity 23B, and is separated from, and does not communicate with, the pressure fluid conduit 22B, which is the first lumen of the catheter tube 20B. The second sensor accommodating portion 30B has an accommodating space 31B that accommodates the second optical sensor 120, and a pressure sampling opening 32B that opens the accommodating space 31B to the outside.

Although the position where the pressure sampling opening 32B is formed is not particularly limited, it is preferably formed on the proximal side of the joining position with the proximal end 50b of the balloon part 50 and near the joining position. Further, the opening diameter of the pressure sampling opening 32B is preferably set to a size that does not allow the second optical sensor 120 to pass through. Thereby, even if, for example, the optical fiber 121 connected to the second optical sensor 120 is broken near the second optical sensor 120, the second optical sensor 120 is prevented from flowing out of the accommodation space 31B. be able to.

Further, the second lumen of the catheter tube 20B has filling hole openings 35B and 36B that open to the outer peripheral surface of the catheter tube 20B in the vicinity of the accommodation space 31B. The filling hole openings 35B and 36B are formed on the distal and proximal sides in the axial direction with the pressure sampling opening 32B in between. In addition, although two filling hole openings 35B and 36B are formed in FIG. 10, the number of filling hole openings 35B and 36B is not particularly limited.

When arranging the second optical sensor 120 in the accommodation space 31B, first, the distal end of the catheter tube 20B before connecting the proximal end of the optical fiber 111 connected to the second optical sensor 120 with the distal tip 60B. It is inserted into the second lumen, which is the sensor housing cavity 23B, through the opening or pressure sampling opening 32B. Then, the optical fiber 121 is pushed forward and the proximal end of the optical fiber 121 is pulled out from the secondary port 82B of the branch part 80B, and the second optical sensor 120 connected to the distal end of the second optical sensor 120 is inserted into the catheter tube 20B. is placed in the accommodation space 31B through the distal end opening or the pressure sampling opening 32B.

Next, the curable resin 141 flows through the filling hole openings 35B and 36B to fill the second lumen on the distal and proximal sides of the pressure sampling opening 32B. Then, the curable resin 141 is cured. Thereby, the optical fiber 121 is fixed within the second lumen by the curable resin flowing from the filling hole opening 36B. Further, the distal side and the proximal side of the second lumen are closed with the curable resin across the pressure sampling opening 32B. The filling amount of the curable resin 141 is preferably adjusted to an amount that closes the distal and proximal sides of the second lumen, and does not reach the second optical sensor 120 disposed in the housing space 31B. It is preferable that the temperature be adjusted to . After filling the curable resin 141, the resin may be dripped into the filling hole openings 35B and 36B to form a resin film. Thereafter, the proximal end 50b of the balloon portion 50 is joined to the outer peripheral surface of the catheter tube 20B by means such as heat fusion or adhesion.

Examples of the curable resin 141 include moisture-curing adhesives such as cyanoacrylate adhesives, heat-curing adhesives such as one-component epoxy adhesives, and two-component mixed curing adhesives such as two-component epoxy adhesives. Mold adhesive can be used.

The distal and proximal sides of the second lumen sandwiching the pressure sampling opening 32B are closed with the curable resin 141, so that the housing space 31B is substantially open only at the pressure sampling opening 32B. Next, the pressure transmitting substance 142 flows into the housing space 31B through the pressure sampling opening 32B, and the pressure transmitting substance 142 is filled around the second optical sensor 120 housed in the housing space 31B.

As the pressure transmitting substance 142, for example, a gel-like substance such as silicone gel, polyacrylamide gel, or polyethylene oxide gel, or an oil-like substance such as silicone oil can be used.

When filling the accommodation space 31B with the curable resin 141, it is preferable that no air remains in the accommodation space 31B (especially around the second optical sensor 120). For example, in addition to the pressure sampling opening 32B, a resin filling hole that opens the accommodation space 31B to the outside is provided, and the pressure transmitting substance 142 flows through the resin filling hole and the air in the accommodation space 31B is discharged from the pressure sampling opening 32B. It may also be allowed to escape to the outside. When a resin filling hole is provided, pressure is released from the resin filling hole by filling the accommodation space 31B with the pressure transmitting substance 142 and then dropping the resin into the opening of the resin filling hole to form a resin film. The transmission substance 142 may be prevented from flowing out.

Note that in the above-described configuration, the optical fiber 121 is fixed by flowing the curable resin 141 through the filling hole openings 35B and 36B and curing it, and the accommodation space 31B is opened only by the pressure sampling opening 32B. Although the partition walls are formed using the curable resin 141, the method for fixing the optical fibers 121 and forming the partition walls in the housing space 31B is not limited to this method. For example, a partition material through which the optical fiber 121 can be inserted and fixed and which can seal the pressure transmitting substance 142 may be disposed within the second lumen. This partition material can be made of a resin material such as urethane, acrylic, silicone, or epoxy. Further, by using both the curable resin 141 and the partition wall material, the accommodation space 31B that accommodates the second optical sensor 120 may be opened to the outside only through the pressure sampling opening 32B.

The method of using the balloon catheter 10B in the second embodiment is the same as the method of using the balloon catheter 10A in the first embodiment described above. In addition, similarly to the first embodiment, the pressure values detected by the first optical sensor 110 and the second optical sensor 120 are processed by the pressure measurement processing device 200 (see FIG. 5), and the degree of expansion of the balloon part 50 and the blood vessel are processed. It is also possible to display on the display (display device) 250 the occupancy rate of the balloon section 50 with respect to the above.

<Third embodiment>
A third embodiment of the present invention will be described below with reference to FIGS. 11 and 12. In addition, below, the same code|symbol is attached|subjected about the same component as 1st and 2nd embodiment mentioned above, and the description may be abbreviate|omitted or simplified.

FIG. 11 is a schematic cross-sectional view showing an example of a balloon catheter 10C according to the third embodiment of the present invention. As shown in FIG. 11, a balloon catheter 10C according to the third embodiment has a balloon section 50 attached to the distal end of a long catheter tube 20C, and a branch section 80C connected to the proximal end of the catheter tube 20C. It has been roughly configured. A balloon catheter 10C in the third embodiment corresponds to the balloon catheter 10 shown in FIG. 1, and a catheter tube 20C in the third embodiment corresponds to the catheter tube 20 shown in FIG.

The catheter tube 20C is an elongated member having a tubular structure and having a lumen formed therein along the axial direction. The catheter tube 20C is a double lumen type tube in which two lumens are formed.

One of the two lumens (first lumen) formed in the catheter tube 20C communicates with the inside of the balloon part 50 via a pressure fluid communication port 21C that opens inside the balloon part 50. It functions as a pressure fluid introduction path 22C that allows pressure fluid to flow in and out of the balloon portion 50. That is, inside the catheter tube 20C, a fluid circulation lumen is formed in the axial direction, which has a communication port to the inside of the balloon portion 50 and allows pressure fluid to flow therethrough. The pressure fluid communication port 21C in the third embodiment is the distal end opening of the catheter tube 20C. Furthermore, the first lumen that functions as the pressure fluid guide path 22C of the catheter tube 20C also serves as an insertion path for the optical fiber 111 connected to the first optical sensor 110.

A proximal end 50b of a balloon portion 50 is joined to a distal end of the catheter tube 20C.

The second lumen of the catheter tube 20C is a sensor accommodation cavity 23C used to provide a second sensor accommodation part 30C in which the second optical sensor 120 is disposed, and an optical fiber connected to the second optical sensor 120. It also has the role of an insertion path for 121. A second sensor accommodating portion 30C is provided in the second lumen of the catheter tube 20C on the proximal side of the joining position where the proximal end portion 50b of the balloon portion 50 is joined. Details of the second sensor housing section 30C will be described later.

Here, the first lumen of the catheter tube 20C is used as the insertion path for the optical fiber 111 connected to the first optical sensor 110, but the second lumen of the catheter tube 20C is used as the insertion path for the optical fiber 111. May be used as

The catheter tube 20C is provided with a second sensor accommodating section 30C that accommodates the second optical sensor 120 on the proximal side of the joining position where the proximal end 50b of the balloon section 50 is joined. Details of the second sensor housing section 30C will be described later.

Although not particularly limited, the catheter tube 20C is made of synthetic resin such as polyurethane, polyvinyl chloride, polyethylene terephthalate, polyamide, etc., and may have a stainless steel wire embedded therein. The inner diameter and wall thickness of the first and second lumens of the catheter tube 20C are not particularly limited, but the inner diameter of the second lumen is large enough to accommodate the second optical sensor 120 through it. It is preferable that there be. Further, it is preferable to ensure the flow rate of the pressure fluid in the first lumen functioning as the pressure fluid introduction passage 22C, and it is preferable that the inner diameter of the first lumen is larger than the inner diameter of the second lumen. The length of the catheter tube 20C is also not particularly limited, but is preferably 300 to 800 mm.

A guide wire tube 40C is inserted into the first lumen of the catheter tube 20C. That is, the guide wire tube 40C is inserted into the fluid circulation lumen of the catheter tube 20C, and the catheter tube 20C is an outer tube, and the guide wire tube 40C is inserted inside the catheter tube 20C as an inner tube. The guide wire tube 40C is a long member having a tubular structure that extends in the axial direction inside the catheter tube 20C and the balloon section 50.

The inner circumferential surface of the first lumen of the catheter tube 20C and the outer circumferential surface of the guide wire tube 40C may be fixed partially or entirely in the axial direction with an adhesive or the like. By fixing the catheter tube 20C and the guide wire tube 40C, the flow resistance of the pressure fluid in the pressure fluid guide path 22C in the catheter tube 20C is reduced. The adhesive used for fixing is not particularly limited, and adhesives such as cyanoacrylate adhesives and epoxy adhesives can be used, and it is particularly preferable to use cyanoacrylate adhesives.

The lumen formed inside the guide wire tube 40C does not communicate with the inside of the balloon section 50 and the pressure fluid conduit 22C inside the catheter tube 20C, and guides the balloon section 50 to a predetermined position within the blood vessel. It functions as a guide wire passageway 41C through which a guide wire (not shown) used for this purpose can be inserted. That is, a guide wire insertion lumen is formed in the axial direction inside the guide wire tube 40C. The distal end of the guidewire tube 40C is attached to the proximal end of the distal tip 60C by means such as heat fusion or adhesive so that the internal guidewire passage 41C and the guidewire insertion hole 61C of the distal tip 60C communicate with each other. connected to the section. The proximal end of the guidewire tube 40C is connected to the branch 80C so as to communicate with a secondary port 82C of the branch 80C, which will be described later.

The outer diameter of the guide wire tube 40C is not particularly limited, but is preferably 0.5 to 1.5 mm, and preferably 30 to 60% of the first inner diameter of the catheter tube 20C. The outer diameter of the guidewire tube 40C is approximately the same along the axial direction. The guide wire tube 40C is made of, for example, a synthetic resin tube such as polyurethane, polyvinyl chloride, polyethylene, polyamide, polyetheretherketone (PEEK), a nickel titanium alloy thin tube, a stainless steel thin tube, or the like. Further, when the guide wire tube 40C is made of a synthetic resin tube, a stainless steel wire or the like may be buried therein.

A balloon portion 50 is attached to the distal end of the catheter tube 20C. The balloon portion 50 is configured to be expandable (inflatable) and deflated in a direction perpendicular to the axial direction of the catheter tube 20C. In use, the balloon section 50 is inserted in a deflated state and placed at a predetermined position within a blood vessel, and then expanded by allowing pressure fluid to flow into the inside of the balloon section 50, thereby expanding the distal side of the balloon section 50. It is possible to suppress blood flow between the proximal side and the proximal side.

The balloon portion 50 is composed of a thin film having a thickness of approximately 50 to 500 μm. The material of the thin film constituting the balloon portion 50 is not particularly limited, but is preferably a material with excellent elasticity, and is made of, for example, natural rubber, isoprene rubber, silicone rubber, polyurethane elastomer, or the like.

The outer diameter and length of the balloon portion 50 are determined according to the inner diameter of the blood vessel whose blood flow is to be suppressed by the balloon portion 50, and the like. The outer diameter of the balloon portion 50 when expanded is preferably 12 to 40 mm, and the length of the balloon portion 50 is preferably 30 to 90 mm.

The distal end 50a of the balloon part 50 is joined to the outer peripheral surface of the distal tip 60C, and the proximal end 50b of the balloon part 50 is joined to the outer peripheral surface of the distal end of the catheter tube 20C. . The balloon portion 50, the distal tip 60C, and the catheter tube 20C are joined by, for example, heat fusion or adhesion. A contrast marker made of a radiopaque metal ring or the like is arranged on the outer peripheral surface of the distal end of the catheter tube 20C, and the proximal end 50b of the balloon part 50 is placed on the outer peripheral surface of the catheter tube 20C and the contrast marker from above. may be joined.

The distal end 50a and the proximal end 50b of the balloon part 50 are arranged on the outer peripheral surface of the catheter tube 20C and the outer periphery of the distal tip 60C, respectively, so that the pressure fluid inside the balloon part 50 does not leak to the outside of the balloon part 50. connected to the surface. Therefore, the inside of the balloon portion 50 communicates only with the pressure fluid passage 22C formed inside the catheter tube 20C through the pressure fluid passage 21C, which is an opening at the distal end of the catheter tube 20C. Thereby, when the pressure fluid is introduced into and led out of the balloon section 50 through the pressure fluid communication port 21C, the balloon section 50 can be expanded and contracted.

The balloon portion 50 is inserted into a blood vessel in a deflated state. After the balloon portion 50 is placed at a predetermined position within the blood vessel, the balloon portion 50 is expanded by introducing pressure fluid into the inside.

A proximal end of a distal tip 60C is connected to a distal end of the guidewire tube 40C. The distal tip 60C is the most distal member of the balloon catheter 10C. The distal tip 60C has, for example, a cylindrical shape with a smooth curved surface or a tapered shape on the distal side so as not to damage the blood vessel wall etc. when inserted into the blood vessel.

The distal tip 60C may be the same as the distal tip 60A of the first embodiment described above. A guide wire insertion hole 61C and a first sensor accommodating portion 70C are formed inside the distal tip 60C. The guide wire insertion hole 61C is formed so that the guide wire tube 40C can be inserted therein, similar to the guide wire insertion hole 61A of the distal tip 60A in the first embodiment, and the guide wire tube 40C is inserted into the guide wire insertion hole 61C by heat fusion or bonding. 40C and the distal tip 60C can be connected.

The distal end portion 50a of the balloon portion 50 is joined to the outer peripheral surface of the distal tip 60C. The connection between the balloon portion 50 and the distal tip 60C is performed by heat fusion, adhesion, or the like.

The distal tip 60C is provided with a first sensor accommodating section 70C that accommodates the first optical sensor 110 on the distal side of the joining position where the distal end 50a of the balloon section 50 is joined. The first sensor accommodating portion 70C also has the same configuration as the first sensor accommodating portion 70A of the distal tip 60A in the first embodiment. Similarly, the pressure transmitting substance 132 may be filled around the first optical sensor 110.

A balloon catheter 10C in the third embodiment includes a first optical sensor 110 disposed distal to the balloon part 50 and a second optical sensor 120 disposed proximal to the balloon part 50. . The first optical sensor 110 and the second optical sensor 120 can be the same as those in the first embodiment described above.

The first optical sensor 110 is arranged in a first sensor accommodating portion 70C provided in the distal tip 60C. The first optical sensor 110 is an optical pressure sensor that can measure pressure using light, and can measure blood pressure on the proximal side of the balloon section 50.

The first sensor accommodating portion 70C provided in the distal tip 60C is an accommodating space large enough to accommodate the first optical sensor 110, similar to the first sensor accommodating portion 70C of the distal tip 60A in the first embodiment. 71C, and has a pressure sampling opening 72C opened on the outer peripheral surface of the distal tip 60C.

A first optical sensor 110 is accommodated in the accommodation space 71C of the first sensor accommodation section 70C, and the optical fiber 111 integrated and connected to the first optical sensor 110 is inserted into the balloon section 50 through the proximal surface of the distal tip 60C. is being extended.

The pressure sampling opening 72C only needs to be opened so that the first optical sensor 110 can detect external pressure (that is, the blood pressure of blood flowing in the blood vessel), and its opening diameter is not particularly limited. It is preferable that the sensor 110 is formed in such a size or shape that it cannot pass through the pressure sampling opening 72C. Further, the opening position of the pressure sampling opening 72C may be any position where external pressure can be appropriately detected. Preferably, it is formed. The accommodation space 71C of the first sensor accommodation part 70C is substantially opened only by the pressure sampling opening 72C.

The optical fiber 111 extending inside the balloon portion 50 through the proximal surface of the distal tip 60C further extends into the lumen (pressure fluid conduit 22C) of the catheter tube 20C. The proximal end of the optical fiber 111 is connected to a tertiary port 83C of a branch 80C, which will be described later.

Inside the balloon portion 50, the optical fiber 111 is spirally wound around the outer peripheral surface of the guide wire tube 40C and extends in the axial direction of the guide wire tube 40C. As described above, when inserted into a blood vessel, the deflated balloon part 50 is wrapped around the outer peripheral surface of the guide wire tube 40C. The guide wire tube 40C is wound around the outer peripheral surface of the guide wire tube 40C.

The optical fiber 111 extends in the axial direction of the catheter tube 20C in the first lumen of the catheter tube 20C. A part of the outer peripheral surface or the entire axial direction of the optical fiber 111 may be fixed to the inner peripheral surface of the catheter tube 20C or the outer peripheral surface of the guide wire tube 40C with an adhesive or the like.

The second optical sensor 120 is arranged in a second sensor housing section 30C provided in the catheter tube 20C. The second optical sensor 120 is an optical pressure sensor that can measure pressure using light, and can measure blood pressure on the proximal side of the balloon section 50.

The second sensor accommodating portion 30C provided in the catheter tube 20C forms an accommodating space 31C having a size capable of accommodating the second optical sensor 120, and also has a pressure sampling opening opened on the outer peripheral surface of the catheter tube 20C. It has a section 32C. In the third embodiment, the second sensor accommodating portion 30C is formed using a part of the second lumen of the catheter tube 20C.

A second optical sensor 120 is accommodated in the accommodation space 31C of the second sensor accommodation section 30C, and an optical fiber 121 integrated and connected to the second optical sensor 120 extends through the second lumen of the catheter tube 20C. .

The pressure sampling opening 32C only needs to be opened so that the second optical sensor 120 can detect external pressure (that is, the blood pressure of blood flowing in the blood vessel), and the opening diameter is not particularly limited. It is preferable that the sensor portion of the sensor 120 is formed in such a size or shape that it cannot pass through the pressure sampling opening. Further, the opening position of the pressure sampling opening 32C may be any position where external pressure can be detected. It is preferable that

As will be described later with reference to FIG. 12, the second lumen of the catheter tube 20C is used as a through hole for the optical fiber 121. It is blocked by 141 etc. Thereby, the accommodation space 31C of the second sensor accommodation section 30C is substantially opened only by the pressure sampling opening 32C.

Further, as will be described later with reference to FIG. 12, in the accommodation space 31C of the second sensor accommodation section 30C, the pressure transmitting substance 142 is placed around the second optical sensor 120 while the second optical sensor 120 is accommodated therein. May be filled. The pressure transmitting substance 142 filled in the accommodation space 31C can directly contact the outside through the pressure sampling opening 32C, and can transmit the external pressure applied to the pressure transmitting substance 142 to the second optical sensor 120.

A proximal end portion of the optical fiber 121 extending in the axial direction through the second lumen of the catheter tube 20C is connected to a tertiary port 83C of a branch portion 80C, which will be described later.

The optical fiber 121 extends in the axial direction of the catheter tube 20C in the second lumen of the catheter tube 20C. A part of the outer peripheral surface or the entire axial direction of the optical fiber 121 may be fixed to the inner peripheral surface of the catheter tube 20C with an adhesive or the like.

A branch portion 80C is connected to the proximal end of the catheter tube 20C. The branch portion 80C is formed separately from the catheter tube 20C, and is connected to the catheter tube 20C by means such as heat fusion or adhesion. The branch portion 80C includes a primary passage 84C that communicates with the first lumen (pressure fluid conduit 22C) and the primary port 81C in the catheter tube 20C, and a primary passage 84C that communicates with the guidewire passage 41C and the secondary port 82C in the guidewire tube 40C. a tertiary passage 86C that communicates with the first lumen (pressure fluid guide passage 22C), second lumen (sensor housing cavity 23C), and tertiary port 83C of the catheter tube 20C through which the optical fibers 111 and 121 extend; is formed.

The primary port 81C is configured so that a syringe or the like can be connected thereto, and pressure fluid can be introduced into and led out of the balloon portion 50 using the syringe or the like. The primary passage 84C extends linearly at the distal end of the branch 80C and is directly connected to the pressure fluid conduit 22C. Thereby, inside the pressure fluid conduit 22C, the flow path resistance of the pressure fluid introduced and led out via the primary port 81C is reduced.

Note that the second lumen of the catheter tube 20C may be closed with the optical fiber 121 passed through it near the proximal end of the catheter tube 20C so that the pressure fluid does not flow within the second lumen. . The pressure fluid is not particularly limited, but physiological saline is preferably used.

The secondary port 82C allows insertion of a guide wire (not shown). A secondary passage 85C communicating with the secondary port 82C extends linearly at the distal end of the branch portion 80C. At the distal end of the branch 80C, the secondary passage 85C is coupled to the proximal end of the guidewire tube 40C so as to communicate with the guidewire passage 41C. The guide wire inserted from the secondary port 82C passes through the secondary passage 85C and the guide wire passage 41C, and can be exposed to the outside from the guide wire insertion hole 61C of the distal tip 60C.

A tertiary passage 86C through which the optical fiber 121 is inserted communicates with the tertiary port 83C. The tertiary passage 86C communicates with the primary passage 84C, and the proximal ends of the optical fiber 111 connected to the first optical sensor 110 and the optical fiber 121 connected to the second optical sensor 120 are pulled out from the tertiary port 83C. It looks like this. The optical fibers 111 and 121 are adhesively fixed inside the tertiary passage 86C close to the outlet of the tertiary port 83C. The outlet of the optical fibers 111, 121 in the tertiary port 83C has a seal structure to prevent the pressure fluid flowing through the primary passage 84C from leaking to the outside.

An optical connector 150 is connected to the proximal ends of the optical fibers 111 and 121, and the above-described pressure measurement processing device 200 (see FIG. 5) is connected to the optical connector 150. As described above, the pressure measurement processing device 200 is configured to perform processing related to the pressure detected by each of the first optical sensor 110 and the second optical sensor 120.

As described above, the distal tip 60C can be the same as the distal tip 60A of the first embodiment, and has the same configuration as the distal tip 60A shown in FIG.

FIG. 12 is a partially enlarged sectional view of the vicinity of the proximal end 50b of the balloon portion 50 of the balloon catheter 10C shown in FIG.

As shown in FIG. 12, the proximal end 50b of the balloon portion 50 is joined to the outer peripheral surface of the distal end of the catheter tube 20C. The first lumen functioning as the pressure fluid passage 22C of the catheter tube 20C opens inside the balloon portion 50 at the pressure fluid passage 21C, which is the distal end opening of the catheter tube 20C.

A guide wire tube 40C is inserted into the first lumen of the catheter tube 20C. The inner lumen of the guide wire tube 40C functions as a guide wire passageway 41C through which a guide wire (not shown) can be inserted. The guide wire tube 40C is exposed from the distal end opening of the catheter tube 20C, extends into the balloon portion 50, and is connected to the distal tip 60C as described above.

An optical fiber 111 is further inserted into the first lumen of the catheter tube 20C. The optical fiber 111 is exposed from the distal end opening of the catheter tube 20C and extends into the balloon section 50, and is connected to the first optical sensor housed in the first sensor housing section 70C of the distal tip 60C as described above. 110.

An optical fiber 121 is inserted into the second lumen of the catheter tube 20C. The optical fiber 121 is connected to a second optical sensor 120 housed in a second sensor housing section 30C formed at the distal end of the catheter tube 20C.

A second sensor accommodating portion 30C that accommodates the second optical sensor 120 is formed at the distal end of the catheter tube 20C. The second sensor accommodating portion 30C is provided in the second lumen, which is the sensor accommodating cavity 23C, and is separated from and does not communicate with the pressure fluid conduit 22C, which is the first lumen of the catheter tube 20C. The second sensor accommodating portion 30C has an accommodating space 31C that accommodates the second optical sensor 120, and a pressure sampling opening 32C that opens the accommodating space 31C to the outside.

Although the position where the pressure sampling opening 32C is formed is not particularly limited, it is preferably formed on the proximal side of the joining position with the proximal end 50b of the balloon part 50 and near the joining position. Further, the opening diameter of the pressure sampling opening 32C is preferably set to a size that does not allow the second optical sensor 120 to pass through. Thereby, even if, for example, the optical fiber 121 connected to the second optical sensor 120 is broken near the second optical sensor 120, the second optical sensor 120 is prevented from flowing out of the accommodation space 31C. be able to.

Further, the second lumen of the catheter tube 20C has a filling hole opening 35C that opens on the outer peripheral surface of the catheter tube 20C and a distal end opening 36C that opens at the distal end in the vicinity of the accommodation space 31C. ing. The filling hole opening 35C is formed closer to the axial direction than the pressure sampling opening 32C. In addition, although one filling hole opening 35C is formed in FIG. 12, the number of filling hole openings 35C is not particularly limited.

When arranging the second optical sensor 120 in the accommodation space 31C, first, the proximal end of the optical fiber 111 connected to the second optical sensor 120 is connected to the sensor through the distal end opening 36C or the pressure sampling opening 32C. It is inserted into the second inner cavity which is the accommodation cavity 23C. Then, the optical fiber 121 is pushed forward and the proximal end of the optical fiber 121 is pulled out from the tertiary port 83C of the branch part 80C, and the second optical sensor 120 connected to the distal end of the second optical sensor 120 is inserted into the catheter tube 20C. It is placed in the accommodation space 31C through the distal end opening 36C or the pressure sampling opening 32C.

Next, the curable resin 141 flows in from the filling hole opening 35C to fill the second lumen with the curable resin 141. Then, the curable resin 141 is cured. As a result, the optical fiber 121 is fixed within the second lumen by the hardening resin flowing from the filling hole opening 35C. Further, the vicinity of the filling hole opening 35C of the second lumen is closed with the curable resin. The filling amount of the curable resin 141 is preferably adjusted to an amount that can close the filling hole opening 35C and fix the optical fiber 121, and the amount does not reach the second optical sensor 120 disposed in the accommodation space 31C. It is preferable to adjust it to .

Further, the curable resin 141 flows in from the distal end opening 36C, filling the distal side of the second lumen with the curable resin 141, and hardening the curable resin 141. Thereby, the distal side of the pressure sampling opening 32C of the second lumen is closed with the curable resin. The filling amount of the curable resin 141 is preferably adjusted to an amount that closes the distal side of the second lumen, and is adjusted to an amount that does not reach the second optical sensor 120 disposed in the accommodation space 31C. It is preferable. Alternatively, after filling the curable resin 141, the resin may be dripped into the filling hole opening 35C and the distal end opening 36C to form a resin film. Thereafter, the proximal end 50b of the balloon portion 50 is joined to the outer peripheral surface of the catheter tube 20C by means such as heat fusion or adhesion.

Examples of the curable resin 141 include moisture-curing adhesives such as cyanoacrylate adhesives, heat-curing adhesives such as one-component epoxy adhesives, and two-component mixed curing adhesives such as two-component epoxy adhesives. Mold adhesive can be used.

The distal and proximal sides of the second lumen sandwiching the pressure sampling opening 32C are closed with the curable resin 141, so that the housing space 31C is substantially open only at the pressure sampling opening 32C. Next, the pressure transmitting substance 142 flows into the housing space 31C through the pressure sampling opening 32C, and the pressure transmitting substance 142 is filled around the second optical sensor 120 housed in the housing space 31C.

As the pressure transmitting substance 142, for example, a gel-like substance such as silicone gel, polyacrylamide gel, or polyethylene oxide gel, or an oil-like substance such as silicone oil can be used.

When filling the housing space 31C with the curable resin 141, it is preferable that no air remains in the housing space 31C (especially around the second optical sensor 120). For example, in addition to the pressure sampling opening 32C, a resin filling hole that opens the housing space 31C to the outside may be provided, and the pressure transmitting substance 142 may flow in through the resin filling hole to drain the air in the housing space 31C from the pressure sampling opening 32C. It may also be allowed to escape to the outside. When a resin filling hole is provided, pressure is released from the resin filling hole by filling the accommodation space 31C with the pressure transmitting substance 142 and then dropping the resin into the opening of the resin filling hole to form a resin film. The transmission substance 142 may be prevented from flowing out.

In the above-described configuration, the optical fiber 121 is fixed by flowing the curable resin 141 through the filling hole opening 35C and the distal end opening 36C and curing it, and the accommodation space 31C is connected to the pressure sampling opening 32C. Although the partition wall is formed of the curable resin 141 so as to open with a chisel, the method for fixing the optical fiber 121 and forming the partition wall in the accommodation space 31C is not limited to this method. For example, a partition material through which the optical fiber 121 can be inserted and fixed and which can seal the pressure transmitting substance 142 may be disposed within the second lumen. This partition material can be made of a resin material such as urethane, acrylic, silicone, or epoxy. Further, by using both the curable resin 141 and the partition wall material, the accommodation space 31C that accommodates the second optical sensor 120 may be opened to the outside only through the pressure sampling opening 32C.

The method of using the balloon catheter 10C in the third embodiment is the same as the method of using the balloon catheter 10A in the first embodiment described above. In addition, similarly to the first embodiment, the pressure values detected by the first optical sensor 110 and the second optical sensor 120 are processed by the pressure measurement processing device 200 (see FIG. 5), and the degree of expansion of the balloon part 50 and the blood vessel are processed. It is also possible to display on the display (display device) 250 the occupancy rate of the balloon section 50 with respect to the above.

The balloon catheter 10 according to the present invention has a configuration in which the second sensor accommodating portion 30A is provided in the single lumen type catheter tube 10 as in the first embodiment, and a double lumen type catheter as in the second and third embodiments. This includes both configurations in which second sensor accommodating portions 30B and 30C are provided in the inner lumen (second lumen) of the tube 10.

Further, the balloon catheter 10 according to the present invention has a configuration in which guide wire tubes 40A and 40C are provided as in the first and third embodiments, and a configuration in which the guide wire is passed only through the distal tip 60B as in the second embodiment. This includes both configurations in which a guide wire insertion hole 61B is provided. Furthermore, when the balloon catheter 10 according to the present invention is configured with a guidewire tube, the proximal end of the guidewire is removed from the guidewire tubes 40A, 40C outside the body as in the first and third embodiments. The proximal end of the guidewire can be inserted into the guidewire tube within the body (within a blood vessel) by providing a side hole in the guidewire tube so as not to impair the airtightness of the fluid flow lumen. (also called monorail type).

Further, the balloon catheter 10 according to the present invention has a configuration in which the guide wire tubes 40A, 40C and distal tips 60A, 60C are connected as in the first and third embodiments, and a configuration in which the guide wire tubes 40A, 40C are connected to the distal tips 60A, 60C as in the second embodiment. This includes both configurations in which the distal tip 60B is connected.

Further, in the balloon catheter 10 according to the present invention, the distal ends of the catheter tubes 20A, 20C are located near the proximal end 50b of the balloon part 50, as in the first and third embodiments, and the catheter tubes 20A, 20C does not extend inside the balloon part 50, the distal end of the catheter tube 20B is located near the distal end 50a of the balloon part 50 as in the second embodiment, and the catheter tube 20B does not extend inside the balloon part 50. Contains both configurations that extend within the .

In the balloon catheter 10 according to the present invention, if the first optical sensor 110 can be disposed distal to the balloon part 50 and the second optical sensor 120 can be disposed proximal to the balloon part 50, the first optical sensor 10 described above can be arranged. -Includes not only the configuration in the third embodiment but also those that can be realized by combining various configurations. For example, by selecting either a single lumen type or a double lumen type for the catheter tube 10, and selecting either an over-the-wire type or a monorail type for the guide wire, and combining these, the balloon catheter according to the present invention 10 may be realized.

Hereinafter, the effects of the present invention will be explained.

Balloon catheters 10, 10A, 10B, 10C according to the present invention are used to occlude blood vessels, and include catheter tubes 20, 20A, 20B, 20C, and at least the proximal end portion 50b of the catheter tubes 20, 20A. , 20B, and 20C, the balloon part 50 expands and contracts, and the pressure can be measured using light. A first optical sensor 110 that measures the blood pressure in the blood vessel on the distal side and a first optical sensor 110 that can measure pressure using light and are disposed on the proximal side of the balloon section 50. and a second optical sensor 120 that measures blood pressure in the blood vessel on the side.

With the above configuration, blood pressure can be measured by the first optical sensor 110 disposed on the distal side of the balloon part 50 and the second optical sensor 120 disposed on the proximal side of the balloon part 50. Based on these measured pressure values, the degree of expansion of the balloon portion 50 can be confirmed. In addition, by using an optical sensor that measures pressure using light, it is less susceptible to electrical noise and can accurately and stably measure blood pressure even when using devices that can generate electric fields, such as electric scalpels. and can be measured. Furthermore, since the optical sensor has small fluctuations (drift) due to temperature changes and the passage of time, it is possible to accurately and stably measure blood pressure even in an internal environment that can change over time.

Balloon catheters 10, 10A, 10B, and 10C according to the present invention have distal tips 60A, 60B, and 60C disposed at their distal ends and to which distal ends 50a of balloon portions 50 are joined. Fluid circulation lumens (pressure fluid conduit passages 22A, 22B, 22C) having communication ports that communicate with the inside of the balloon part 50 are formed in the catheter tubes 20, 20A, 20B, and 20C in the axial direction. The optical sensor 110 is housed in first sensor accommodating parts 70A, 70B, and 70C that are formed in the tip tips 60A, 60B, and 60C so as to open at the outer peripheral surfaces of the tip tips 60A, 60B, and 60C, and the second light Second sensor housing portions 30A, 30B are formed on the proximal side of the balloon portion 50 of the catheter tubes 20, 20A, 20B, 20C so that the sensor 120 opens on the outer peripheral surface of the catheter tubes 20, 20A, 20B, 20C. , 30C.

With the above configuration, the first optical sensor 110 and the first optical sensor 110 and Two optical sensors 120 can be arranged respectively, and the blood pressure can be measured on the distal side and the proximal side of the balloon section 50 without interfering with the expansion and contraction of the balloon section 50.

In the balloon catheters 10 and 10B according to the present invention, in the above configuration, the distal ends of the catheter tubes 20 and 20B may be connected to the proximal end of the distal tip 60B.

With the above configuration, the distal ends of the catheter tubes 20, 20B are fixed to the distal tip 60B, so the positions of the distal tip 60B and the balloon portion 50 can be controlled by the catheter tubes 20, 20B.

In the above configuration, the balloon catheter 10B according to the present invention has a guide wire insertion hole having a distal opening 62B that opens at the distal end of the distal tip 60B and a side opening 63B that opens at the side surface of the distal tip 60B. 61B may be formed on the distal tip 60B.

With the above configuration, by inserting the guide wire through the guide wire insertion hole 61B so as to insert it from the side opening 63B and exposing it from the distal end opening 62B, the distal end of the balloon catheter 10B can be inserted using the guide wire. can be guided to a desired location within the body.

The balloon catheters 10, 10A, 10C according to the present invention have the above configuration and are inserted into the fluid flow lumens (pressure fluid insertion passages 21A, 21C) of the catheter tubes 20, 20A, 20C, and are used for guide wire insertion. It has guide wire tubes 40A and 40C in which lumens (guide wire insertion passages 41A and 41C) are formed in the axial direction, and a tip opening 62A and a tip tip 60A that open at the distal end of the tip tips 60A and 60C, Guide wire insertion holes 61A and 61C having a proximal opening 63A opening at the proximal end of the guide wire 60C are formed in the distal tips 60A and 60C, and are connected to the proximal end 50b of the balloon part 50. The distal ends of the guide wire tubes 40A, 40C exposed from the distal ends of the catheter tubes 20, 20A, 20C are connected to the proximal opening 63A, and a guide wire insertion lumen (guide wire insertion passage 41A, 41C) is connected to the proximal opening 63A. ) may communicate with the guide wire insertion holes 61A and 61C.

With the above configuration, the distal ends of the guidewire tubes 40A, 40C are fixed to the distal tips 60A, 60C, so the positions of the distal tips 60A, 60C and the balloon section 50 are controlled by the guidewire tubes 40A, 40C. be able to. In addition, by inserting the guide wire into the guide wire tubes 40A, 40C and the guide wire insertion holes 61A, 61C so as to expose the guide wire from the distal opening 62A of the distal tips 40A, 40C, the balloon catheter 10A, The distal end of 10C can be guided to a desired location within the body. Furthermore, since the small diameter guide wire tubes 40A and 40C that can be inserted into the fluid flow lumens (pressure fluid insertion passages 21A and 21C) are arranged inside the balloon section 50, the diameter of the balloon section 50 when deflated can be reduced. This makes it easier to insert the distal ends of the balloon catheters 10A, 10C into the body, and reduces the burden on the patient.

In the balloon catheters 10, 10A, 10B, and 10C according to the present invention, in the above configuration, the second sensor housing portions 30A, 30A, and 30C are isolated from the fluid circulation lumens (pressure fluid conduction paths 22A, 22B, and 22C). You can leave it there.

With the above configuration, it is possible to prevent the fluid necessary for expanding the balloon section 50 from flowing out from the second sensor accommodating sections 30A, 30B, and 30C, and it is possible to appropriately expand the balloon section 50.

In the balloon catheters 10, 10B, and 10C according to the present invention, in the above configuration, the sensor lumen (sensor accommodation cavity 23B, 23C) isolated from the fluid circulation lumen (pressure fluid conduction path 22B, 22C) is connected to the catheter tube 20. , 20B, 20C in the axial direction, and second sensor accommodating portions 30B, 30C may be provided within the sensor lumens (sensor accommodating cavities 23B, 23C).

With the above configuration, fluid circulation lumens (pressure fluid conduit passages 22B, 22C) and sensor lumens (sensor accommodation cavities 23B, 23C) are formed in the catheter tubes 20, 20B, 20C. By providing the second sensor accommodating parts 30B, 30C in the cavities 23B, 23C, it is possible to reliably prevent the fluid necessary for expanding the balloon part 50 from flowing out from the second sensor accommodating parts 30B, 30C. 50 can be expanded appropriately.

Further, the pressure measurement processing system according to the present invention is a pressure measurement processing system that performs processing related to pressure values measured by the above-mentioned balloon catheters 10, 10A, 10B, and 10C, and is connected to the first optical sensor 110. The first pressure value and the second light measured by the first optical sensor 110 are based on the light transmitted through the first optical fiber 111 and the second optical fiber 121 connected to the second optical sensor 120, respectively. The present invention is characterized in that it includes a pressure measurement processing device 200 that includes a pressure value calculation unit 202 that calculates each second pressure value measured by the sensor.

With the above configuration, the blood pressure measured by the first optical sensor 110 disposed on the distal side of the balloon part 50 and the second optical sensor 120 disposed on the proximal side of the balloon part 50 is set to the first pressure value. and a second pressure value.

In the pressure measurement processing system according to the present invention, in the above configuration, the pressure measurement processing device 200 monitors whether or not the variation range of the second pressure value falls within a predetermined range when the balloon part 50 is expanded. A monitoring unit 203, a first reference value that is the first pressure value before expanding the balloon part 50, and a second reference value that is the first pressure value when the fluctuation range of the second pressure value is within a predetermined range. and an occupancy rate calculation unit 204 that calculates the occupancy rate of the balloon portion 50 with respect to the blood vessel corresponding to the first pressure value measured by the first optical sensor 110 based on the first pressure value measured by the first optical sensor 110.

With the above configuration, the variation range of the second pressure value is monitored, and when the variation range of the second pressure value falls within a predetermined range, the balloon portion 50 is completely expanded to block the blood vessel. You can confirm that This is particularly useful when the balloon section 50 inserted from the patient's femoral artery is placed in the descending aorta, and when the balloon section 50 is completely expanded and blocks the blood vessel, blood pressure fluctuations will be reduced on the proximal side of the balloon section 50. Therefore, by monitoring the variation range of the second pressure value, the degree of expansion of the balloon portion can be confirmed. Further, for example, when the occupancy rate of the balloon part 50 with respect to the blood vessel is 0% when the measured value by the first optical sensor 110 is the first reference value, and when the measured value by the first optical sensor 110 is the second reference value By setting the occupancy rate of the balloon part 50 with respect to the blood vessel as 100%, the occupancy rate of the balloon part 50 corresponding to the measurement value by the first optical sensor 110 can be calculated as a specific numerical value.

In the above configuration, the pressure measurement processing system according to the present invention includes a display device 250 that displays visual information, and the display device 250 displays the occupancy rate of the balloon section 50 calculated by the occupancy rate calculation section 204. May be displayed.

With the above configuration, the practitioner can visually check the occupancy rate of the balloon section 50 with respect to the blood vessel. This allows the practitioner to grasp the degree of expansion of the balloon section 50, and prevents over-expansion of the balloon section 50, which may cause blood vessel rupture, or sudden contraction of the balloon section 50, which may cause ischemia-reperfusion injury. The expansion and contraction of the balloon portion 50 can be appropriately controlled to prevent this from occurring.

In the pressure measurement processing system according to the present invention, in the above configuration, the display device 250 may display a graph of changes over time of the first pressure value and the second pressure value.

With the above configuration, the practitioner can visually check the change in the degree of expansion of the balloon portion 50 over time.

Note that the embodiments described above are described to facilitate understanding of the present invention, and are not described to limit the present invention. Therefore, each element disclosed in the embodiments described above is intended to include all design changes and equivalents that fall within the technical scope of the present invention.

10, 10A, 10B, 10C Balloon catheter 20, 20A, 20B, 20C Catheter tube 21A, 21B, 21C Pressure fluid conduit 22A Pressure fluid conduit 22B, 22C Pressure fluid conduit (first lumen, fluid circulation lumen)
23B, 23C Sensor housing cavity (second internal cavity, sensor lumen)
30A, 30A, 30C Second sensor housing part 31A, 31B, 31C Housing space 32A, 32B, 32C Pressure sampling opening 33A Optical fiber passage 34A Hole opening 35A, 35B, 35C Filling hole opening 36A, 36B, 36C Distal end opening 40A, 40C Guidewire tube 41A, 41C Guidewire passage 50 Balloon part 50a Distal end 50b Proximal end 60A, 60B, 60C Distal tip 61A, 61B, 61C Guidewire insertion hole 62A, 62B Tip Opening 63A Base opening 63B Side opening 65B Insertion protrusion 70A, 70B, 70C First sensor housing 71A, 71B, 71C Accommodation space 72A, 72B, 72C Pressure sampling opening 73A, 73B Optical fiber through hole 74A, 74B Through hole opening 75A, 75B, 76A, 76B, 77A Filling hole opening 80A, 80B, 80C Branch 81A, 81B, 81C Primary port 82A, 82B, 82C Secondary port 83A, 83C Tertiary port 84A, 84B, 84C Primary passage 85A, 85B, 85C Secondary passage 86A, 86C Tertiary passage 110 First optical sensor 111, 121 Optical fiber 120 Second optical sensor 131, 141 Hardening resin 132, 142 Pressure transmission substance 150 Optical connector 200 Pressure measurement processing device 201 I/F (interface)
202 Pressure value calculation section 203 Fluctuation monitoring section 204 Occupancy rate calculation section 205 Display output section 250 Display (display device)
251 Graph display area 252 Occupancy rate display area 253 Blood pressure value display area

Claims (11)

A balloon catheter used to occlude a blood vessel, the balloon catheter comprising:
catheter tube,
a balloon portion having at least a proximal end joined to the catheter tube and capable of being expanded and deflated;
a first optical sensor that is capable of measuring pressure using light and is disposed distal to the balloon section and measures blood pressure in a blood vessel distal to the balloon section;
a second optical sensor that is capable of measuring pressure using light and is disposed proximal to the balloon section and measures blood pressure in a blood vessel proximal to the balloon section;
A balloon catheter characterized by having. a distal tip disposed at the distal end and joined to the distal end of the balloon portion;
A fluid circulation lumen having a communication port communicating with the inside of the balloon part is formed in the catheter tube in the axial direction,
The first optical sensor is housed in a first sensor accommodating portion formed in the tip tip so as to open at the outer peripheral surface of the tip tip,
Claim characterized in that the second optical sensor is accommodated in a second sensor accommodating portion formed on the proximal side of the balloon portion of the catheter tube so as to open on the outer circumferential surface of the catheter tube. 1. The balloon catheter according to 1. 3. The balloon catheter of claim 2, wherein a distal end of the catheter tube is connected to a proximal end of the distal tip. A guide wire insertion hole having a distal opening opening at a distal end of the distal tip and a side opening opening at a side surface of the distal tip is formed in the distal tip. The balloon catheter according to item 3. a guidewire tube that is inserted into the fluid flow lumen of the catheter tube and has a guidewire insertion lumen formed in the axial direction;
A guidewire insertion hole is formed in the distal tip, the guidewire insertion hole having a distal opening opening at a distal end of the distal tip and a proximal opening opening at a proximal end of the distal tip,
The distal end of the guide wire tube exposed from the distal end of the catheter tube connected to the proximal end of the balloon part is connected to the proximal opening, and the guide wire insertion lumen is connected to the proximal opening. The balloon catheter according to claim 2, wherein the balloon catheter communicates with the guide wire insertion hole. The balloon catheter according to any one of claims 2 to 5, wherein the second sensor housing portion is isolated from the fluid flow lumen. 7. A sensor lumen isolated from the fluid circulation lumen is formed in the catheter tube in the axial direction, and the second sensor housing portion is provided within the sensor lumen. Balloon catheter described in . A pressure measurement processing system that performs processing related to pressure values measured by the balloon catheter according to any one of claims 1 to 7,
a first optical fiber measured by the first optical sensor based on light transmitted through a first optical fiber connected to the first optical sensor and a second optical fiber connected to the second optical sensor, respectively; A pressure measurement processing system comprising a pressure measurement processing device including a pressure value calculation unit that calculates a pressure value and a second pressure value measured by the second optical sensor. The pressure measurement processing device
a fluctuation monitoring unit that monitors whether a fluctuation range of the second pressure value falls within a predetermined range when the balloon portion is expanded;
a first reference value that is the first pressure value before expanding the balloon portion; and a second reference value that is the first pressure value when the fluctuation range of the second pressure value is within a predetermined range. an occupancy rate calculation unit that calculates an occupancy rate of the balloon portion with respect to the blood vessel corresponding to a first pressure value measured by the first optical sensor based on;
The pressure measurement processing system according to claim 8, characterized in that it has a pressure measurement processing system. It has a display device that displays visual information,
The pressure measurement processing system according to claim 9, wherein the display device displays the occupancy rate of the balloon section with respect to the blood vessel calculated by the occupancy rate calculation section. The pressure measurement processing system according to claim 10, wherein the display device displays a graph of changes over time of the first pressure value and the second pressure value.

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