JP2024082732A - Catheter device, medical system, and method for placing a catheter device - Google Patents

Abstract

The present invention aims to prevent unintended detachment of an indwelling part placed in a living body.
[Solution] A catheter device 1 having a retention section 20 to be retained within a living body, the retention section 20 having multiple arm sections 21 that can expand and contract, and the arm sections 21 are composed of a tubular body having an expansion and contraction lumen 23 that can expand and contract as fluid flows in and out.
[Selected Figure] Figure 1

Description

The present invention relates to a catheter device that is placed in a living body, a medical system that uses the device, and a method for placing the catheter device.

Patent Document 1 discloses an indwelling catheter that includes a flexible Malecot tube with multiple slits extending in the longitudinal direction near the tip, a flexible core wire that is arranged to be freely movable in the axial direction along the Malecot tube and whose tip is fixed to a Malecot section (indwelling section) arranged at the tip of the Malecot tube, a cylindrical connector that is fixed to the base end of the Malecot tube and allows the base end of the core wire to protrude from the end, and a rubber body that restricts the core wire from moving freely. When the knob attached to the base end of the core wire is pulled toward the user, the core wire slides toward the user and the Malecot section expands, and when the core wire is pushed in, the Malecot section closes and the catheter can be removed from the living body.

Patent No. 4347486

Because bladder catheters are inserted into the urethra, which is a hollow organ, the JIS standard (JIS T 3214) stipulates that, as a safety requirement, for example, in the case of a 16 Fr catheter, the balloon portion must have a retention force of 1.0 kg or more.

The catheter of Patent Document 1 allows the expansion and contraction of the Malecot portion more easily than a typical balloon-type indwelling bladder catheter, but because the Malecot portion has a simple structure in which a portion of the catheter is expanded and contracted by multiple slits formed in the catheter, it is difficult to ensure the retention force that complies with the aforementioned JIS standard. Thus, the Malecot portion has a disadvantage that it has a weaker retention force than a typical balloon-type balloon and is easily removed from the bladder.

Therefore, when the catheter of Patent Document 1 is placed in the bladder, there is a risk that the malecot portion may fall out of the bladder due to deformation of the expansion portion of the malecot portion caused by external forces, etc., and there is room for improvement.

At least one embodiment of the present invention has been made in consideration of the above circumstances, and specifically aims to provide a catheter device capable of preventing unintended detachment of an indwelling portion placed in a living body, a medical system using the catheter device, and a method for placing the catheter device.

The above object of the present invention is achieved by any one of the following (1) to (22).

(1) A catheter device having an indwelling portion to be placed in a living body, the indwelling portion having a plurality of arms that can be expanded and contracted, the arms being made of a tubular body that can expand and contract in response to the inflow and discharge of fluid.

(2) The catheter device of (1) above, in which the arm portion has an expansion guide portion for promoting radially outward deformation and expanding the arm portion.

(3) The catheter device of (2) above, in which the expansion guide portion has at least one of a recess formed on the outer peripheral surface of the arm portion or a narrow portion that is narrower than the base end of the arm portion.

(4) A catheter device according to any one of (1) to (3) above, in which the living body is a bladder.

(5) The catheter device according to (4) above, wherein the catheter device has a long catheter body, an outlet lumen that guides urine from the bladder to the outside of the living body, and an outlet port that communicates with the outlet lumen, and the arm portion extends from near the outlet port toward the tip side.

(6) The catheter device of (5) above, in which the retention section has a plurality of slits formed between adjacent arm sections in the circumferential direction, and the catheter device has a sensor section that is disposed near the outlet so as to radially overlap the base end of the slit when viewed from the axial direction and acquires biological information.

(7) The catheter device of (5) or (6) above, in which the catheter body is arranged parallel to the outlet lumen and has a sensor lumen that houses the sensor section.

(8) The catheter device is any of the catheter devices (5) to (7) above, having an expansion/contraction section that expands and contracts by deforming the arm section through axial movement of the arm section.

(9) The catheter device of (8) above, in which the expansion/contraction section is a mandrel that can be inserted into the catheter body up to its tip, and whose tip is connected to the arm section so as to be movable in the axial direction.

(10) The catheter device of (8) above, in which the expansion/contraction section has the outlet and an inner cavity that communicates with the outlet and functions as the outlet lumen, and is a hollow pipe that can be inserted into the catheter body up to its tip, and whose tip is connected to the arm section so as to be movable in the axial direction.

(11) The catheter device according to any one of (5) to (8) above, wherein the catheter device has a distal tip disposed at the distal end of the retention portion, the distal tip having a communication hole communicating with the bladder at its distal end and communicating with the outlet lumen at its proximal end.

(12) The catheter device of (11) above, in which the distal end tip has an outer periphery to which the distal end of the arm is connected and a bottom portion connected to the expansion/contraction portion, and the outer periphery of the bottom portion is deformed by tilting outward in the axial direction as the expansion/contraction portion moves in the axial direction.

(13) The catheter device of (6) above, in which the arm portion is eccentrically positioned on the radial direction opposite the sensor portion with respect to the central axis.

(14) The catheter device of (6) above, in which the slit is formed by twisting in the axial direction when the arm portion is contracted.

(15) The catheter device of (6) above, wherein the retention section has a membrane section formed on the base end side of the slit so as to connect the arm sections adjacent to each other in the circumferential direction, and the membrane section is formed in at least one of the slits whose base end does not radially overlap with the sensor section when viewed in the axial direction.

(16) The catheter device of (6) above, wherein the sensor unit includes at least one of an oxygen sensor having an oxygen sensor body capable of detecting the partial pressure of oxygen in the urine as the biological information, or a temperature sensor having a temperature sensor body capable of measuring the temperature of the urine as the biological information.

(17) The catheter device of (16) above, in which the oxygen sensor body is positioned with a portion exposed so as to come into contact with the urine that has flowed into the outlet lumen.

(18) The catheter device of (16) above, in which the temperature sensor body is positioned such that the tip side is not exposed in the outlet lumen so as not to come into contact with the urine flowing into the outlet lumen.

(19) The catheter device of (7) above, wherein the sensor lumen accommodates the sensor portion in a liquid-tight manner.

(20) A catheter device according to any one of (16) to (18), wherein the oxygen sensor is a fluorescent oxygen sensor.

(21) A medical system comprising the catheter device of (6) above, an analysis unit that analyzes the biological information detected by the sensor unit, and a processing control unit that transmits the results of the analysis by the analysis unit to a communication destination, and a measuring device that is placed outside the living body.

(22) A method for placing a catheter device having a placement portion to be placed in a living body, the placement portion having a plurality of arms formed of a tubular body that expands and contracts with deformation and can expand and contract with the inflow and outflow of fluid, the method including the steps of: deforming and expanding the arms of the placement portion delivered to a placement position; and injecting the fluid into the expanded arms to expand the placement portion and place the placement portion at the placement position.

According to one embodiment of the catheter device, the retention portion expands after expansion, making it difficult for the retention portion to come out of the retention position, thereby preventing unintended detachment from the living body.

In addition, according to the medical system of one embodiment of the present invention, it is possible to analyze and transmit biological information using a catheter device that can prevent the indwelling part placed in the body from unintentionally falling off, so that the patient's vital signs can be appropriately monitored.

In addition, according to the placement method of the catheter device of one embodiment of the present invention, the arm portion of the placement portion can be expanded, and then fluid can be introduced into the arm portion to place the placement portion in an expanded state, thereby preventing the placement portion from unintentionally falling off from the placement position.

FIG. 2 is a diagram showing a state before expansion of an indwelling section of the catheter device according to the first embodiment. FIG. 2 is a partial enlarged view of the distal end portion of the catheter device according to the first embodiment, showing the state after expansion of the indwelling section. 2 is a cross-sectional view taken along line AA in FIG. 1 as viewed in the axial direction. 2 is a cross-sectional view taken along line BB in FIG. 1 as viewed in the axial direction. FIG. 4 is a partial enlarged view of the tip of the arm and the tip tip. FIG. 4 is a partially enlarged view of the periphery of the base end of the arm portion. 1 is a conceptual diagram showing a state in which urine is flowing into a sensor portion from a proximal end of a slit in the catheter device according to the first embodiment. FIG. FIG. 13 is a diagram showing a configuration for promoting the expansion of the indwelling portion. FIG. 13 is a diagram showing another configuration for promoting the expansion of the indwelling portion. FIG. 13 is a diagram showing another configuration for promoting the expansion of the indwelling portion. FIG. 13 is a diagram showing a modified example of the catheter device according to the first embodiment. FIG. 7B is a diagram showing an expanded state of the indwelling section shown in FIG. 7A. 13A to 13C are diagrams showing another modified example of the catheter device according to the first embodiment. FIG. 8B is a diagram showing an expanded state of the indwelling section shown in FIG. 8A. 5A to 5C are diagrams illustrating an example of the operation of the catheter device according to the first embodiment. 5A to 5C are diagrams illustrating an example of the operation of the catheter device according to the first embodiment. 5A to 5C are diagrams illustrating an example of the operation of the catheter device according to the first embodiment. 5A to 5C are diagrams illustrating an example of the operation of the catheter device according to the first embodiment. FIG. 1 is a functional block diagram of a medical system according to an embodiment of the present invention. FIG. 11 is a functional block diagram showing a modified example of the medical system according to the present embodiment. FIG. 13 is a diagram showing an arrangement position of a sensor unit in a medical system according to a modified example. FIG. 13 is a diagram showing a state before expansion of an indwelling section of a catheter device according to a second embodiment. FIG. 13 is a diagram showing the state after expansion of the indwelling section of the catheter device according to the second embodiment. FIG. 13 is a diagram showing a state before expansion of an indwelling section of a catheter device according to a third embodiment. FIG. 13 is a diagram showing the state after expansion of the indwelling section of the catheter device according to the third embodiment. 14B is a cross-sectional view taken along line DD in FIG. 14A as viewed in the axial direction. FIG. 13 is a diagram showing a state before expansion of an indwelling section of a catheter device according to a fourth embodiment. FIG. 13 is a diagram showing the state after expansion of the indwelling section of the catheter device according to the fourth embodiment. FIG. 13 is a diagram showing the state after expansion of the indwelling section of the catheter device according to the fifth embodiment.

The following describes in detail the embodiments of the present invention with reference to the drawings. The embodiments shown here are illustrative in order to embody the technical ideas of the present invention, and do not limit the present invention. Furthermore, all other embodiments, examples, and operational techniques that can be conceived by those skilled in the art without departing from the gist of the present invention are included in the scope and gist of the present invention, and are included in the scope of the inventions described in the claims and their equivalents.

Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented diagrammatically with appropriate changes in scale, aspect ratio, shape, etc. from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

For ease of explanation, the following directions are defined in this specification. In FIG. 1, the "longitudinal direction" is the longitudinal direction of the catheter device 1 (left-right direction in the figure), which is the direction along the central axis C of the catheter device 1. The "radial direction" is the direction moving away from or approaching the central axis C of the catheter device 1. The "circumferential direction" is the rotational direction with the central axis C of the catheter device 1 as the reference axis.

In FIG. 1, the "tip" refers to the side that is inserted into the living body (the left side in the figure), and the side opposite the tip (the side where the hub 50 is placed on the right side in the figure) refers to the "base end."

In the following explanation, when ordinal numbers such as "first" and "second" are used, they are used for convenience and do not dictate any particular order, unless otherwise specified.

The catheter device 1 according to the present invention is a medical instrument that is partially retained within a living body, and is intended to drain a specific body fluid from within the living body to the outside of the living body, and to measure specific biological information from the body fluid to monitor the vital signs of an organ. The catheter device 1 can be used, for example, as a device for retaining the retention portion 20, which serves as the retention site, within the bladder, sequentially draining urine 310 stored in the bladder 300 from the base end side of the retention portion 20, and measuring the oxygen partial pressure in the urine 310 (see Figures 9D, 10, etc.).

The placement site of the catheter device 1 is not limited to the bladder 300, but may be any location within a body lumen where the catheter device 1 can be placed. The body fluid from which biological information is measured is also not limited to urine 310, but may be any fluid that can be discharged outside the body and that can be present in the body and whose biological information can be measured.

[First embodiment]
The configuration of a catheter device 1 of a first embodiment will be described with reference to FIGS.

As shown in FIG. 1 or FIG. 2, the catheter device 1 according to the first embodiment includes a long catheter body 10, a retention section 20 disposed at the distal end of the catheter body 10, a distal tip 30 disposed at the distal end of the retention section 20, an expansion/contraction section 40 for expanding and contracting the retention section 20, a hub 50 attached to the proximal end 10b of the catheter body 10, and a sensor section 60 for acquiring biological information.

Figure 1 shows the state of the catheter device 1 when it is inserted and removed, and Figure 2 shows the state of the catheter device 1 when it is indwelling. As shown in Figure 1, the arm portion 21 of the indwelling portion 20 of the catheter device 1 is in a contracted state when it is inserted and removed, and as shown in Figure 2, the arm portion 21 of the indwelling portion 20 is in an expanded and inflated state when it is indwelling.

<Catheter body>
1 or 2, the catheter body 10 is composed of a long tubular member having an inner lumen 10c that communicates from the distal end to the proximal end. The catheter body 10 has an indwelling section 20 disposed on the distal end side. A distal tip 30 is disposed at the distal end 10a (corresponding to the distal end of the indwelling section 20) of the catheter body 10, and the proximal end 10b communicates with a distal end opening 51 of a hub 50.

The portion of the lumen 10c formed in the catheter body 10 that is closer to the base end than the retention section 20 functions as an outlet lumen 11 for discharging urine 310 from the bladder 300 to the outside of the living body. In addition, an opening 10d formed in the catheter body 10 near the base end of the retention section 20 coincides with the tip opening of the outlet lumen 11 and functions as an outlet 12 for urine 310 from the bladder 300.

The catheter body 10 has a sensor lumen 13 that is arranged axially parallel to the outlet lumen 11 from near the opening 10d toward near the base end 10b. As shown in FIG. 3A, the sensor lumen 13 is arranged at a position radially outwardly eccentric from the center of the outlet lumen 11 in the catheter body 10 so as to radially overlap the base end 22b of the slit 22 when viewed from the axial direction.

The sensor lumen 13 houses the sensor section 60 (oxygen sensor body 61a, temperature sensor body 62a, flow rate sensor body 63a) which is composed of various sensors for measuring biological information, and the transmission section (oxygen transmission section 61b, temperature transmission section 62b, flow rate transmission section 63b) which is drawn out from the sensor section 60. As shown in FIG. 1, the sensor lumen 13 starts near the opening 10d of the catheter body 10 which is slightly proximal to the distal end of the outlet lumen 11, and the proximal end of the sensor lumen 13 communicates with the first branch section 14. The sensor section 60 may be disposed on the distal side of the sensor lumen 13, or may be fixed to the distal side.

As shown in FIG. 3A, the sensor lumen 13 has a wall 13a at its tip that extends in a direction intersecting the axial direction. The wall 13a closes the tip opening of the sensor lumen 13. An oxygen sensor body 61a is embedded in the wall 13a with a portion of its tip side exposed. The sensor unit 60 can be liquid-tightly housed in the sensor lumen 13 separate from the outlet lumen 11, so it does not impede the discharge of urine 310 and prevents urine 310 from flowing into the sensor lumen 13, preventing breakdown of the sensor unit 60 and electric shock.

As shown in FIG. 1, the catheter main body 10 has a first branch 14 for drawing out the transmission parts (oxygen transmission part 61b, temperature transmission part 62b, flow rate transmission part 63b) of the sensor part 60 that acquires biological information from the living body. In the first branch 14, the transmission parts (oxygen transmission part 61b, temperature transmission part 62b, flow rate transmission part 63b) of the sensor part 60 that acquires biological information may be inserted axially slidably. In addition, as shown in FIG. 1, the catheter main body 10 has a second branch 15 for flowing fluid into and out of the expansion/contraction lumen 23 of the arm part 21. The second branch 15 is configured to be able to connect the arm part 21 to a device that can expand and contract, such as an indeflator or a syringe.

The catheter body 10 has a fluid lumen 16 through which a fluid for expanding and contracting the retention section 20 flows. As shown in FIG. 3A, the fluid lumen 16 is formed between two slits 22 of different thicknesses of the catheter body 10. As shown in FIG. 4A, the tip of the fluid lumen 16 is connected to the base end of the expansion/contraction lumen 23. There are no particular limitations on the position where the fluid lumen 16 is formed, but considering the effect of the fluid flow on the sensor section 60, it is preferable to form the fluid lumen 16 at a position away from the sensor section 60, such as a thick section on the radial side opposite the sensor section 60.

The catheter body 10 may be made of a material such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, or other polyolefins, soft polyvinyl chloride, or other thermoplastic resins, various rubbers such as silicone rubber and latex rubber, various elastomers such as polyurethane elastomer, polyamide elastomer, polyester elastomer, or crystalline plastics such as polyamide, nylon, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), crystalline polyethylene, or crystalline polypropylene. It is also possible to compound these materials with antithrombotic substances such as heparin, prostaglandins, urokinase, or arginine derivatives to produce materials with antithrombotic properties.

<Detention Department>
The retention section 20 is disposed at the distal end of the catheter body 10, and is retained at a predetermined retention position (bladder 300) inside the living body. The retention section 20 is a portion for maintaining the catheter device 1 inserted inside the living body. The retention section 20 has a plurality of expandable and contractable arm sections 21, and slits 22 formed between adjacent arm sections 21 in the circumferential direction.

The arm portion 21 is composed of a tubular body that can expand and contract with the inflow and discharge of fluid. The distal end 21a of the arm portion 21 is connected to the bottom 31 of the distal tip 30, and the proximal end 21b is connected to the thick portion around the opening 10d of the catheter body 10. As shown in FIG. 2, four arm portions 21 can be provided at equal intervals in the circumferential direction. By arranging the arm portions 21 at equal intervals in the circumferential direction on the catheter body 10, the position of the arm portions 21 during placement can be stabilized.

The arm portion 21 is molded to expand in a natural state. When the tip portion 21a is moved toward the base end by operating the expansion/contraction unit 40 from the state shown in FIG. 1, a part of the arm portion 21 returns to its natural state and expands by bending radially outward (see FIG. 9B). After expansion, the arm portion 21 expands in a bent state when fluid flows into the expansion/contraction lumen 23 (see FIG. 2, FIG. 9C). When the tip portion 21a of the arm portion 21 in the expanded state is moved toward the tip end by operating the expansion/contraction unit 40, the part bent radially outward returns to its original shape and contracts (see FIG. 1, FIG. 9A). Note that the arm portion 21 may be in a naturally contracted state (axially extended state).

The slit 22 is formed along the axial direction of the catheter body 10 so that the arm portion 21 can expand and contract. The distal end 22a of the slit 22 extends to the vicinity of the bottom 31 of the distal tip 30, and the proximal end 22b extends to the vicinity of the opening 10d of the catheter body 10. When the arm portion 21 expands, the side surfaces of the adjacent arm portions 21 are separated in the circumferential direction, forming an opening 22c. The opening 22c communicates with the outlet 12 located at the tip of the outlet lumen 11, and guides urine 310 in the bladder 300 to the outlet 12.

The expansion/contraction lumen 23 is an inner cavity formed within the arm portion 21 and communicates from the distal end 21a to the proximal end 21b of the arm portion 21. As shown in FIG. 4A, the distal end of the expansion/contraction lumen 23 communicates with the internal space 33 through a hole 34 formed in the bottom 31 of the distal tip 30, and as shown in FIG. 4B, the proximal end communicates with the fluid lumen 16.

The expansion/contraction lumen 23 is provided in each of the multiple arm portions 21, and at least one of them is connected to the fluid lumen 16. The expansion/contraction lumen 23 that is connected to the fluid lumen 16 can allow the fluid flowing through the fluid lumen 16 to flow to the internal space 33 of the tip tip 30. In addition, the fluid filled in each of the expansion/contraction lumens 23 can be discharged to the fluid lumen 16 through the expansion/contraction lumen 23 that is connected to the fluid lumen 16 after passing through the internal space 33 of the tip tip.

In this way, the retention section 20 is configured to be expandable and contractible by fluid in addition to expanding and contracting by axial movement of the expansion/contraction section 40, so that when retained in the bladder 300, it can ensure the same retention force as a conventional balloon-type indwelling bladder catheter. Furthermore, in a conventional balloon-type indwelling bladder catheter, the urine drainage port for taking in urine is at the tip side of the balloon, so urination does not occur unless a certain amount of urine accumulates in the bladder. In contrast, in the catheter device 1 of this embodiment, urine 310 can be taken into the catheter from the opening 22c between the multiple arm sections 21, so that urine 310 can be taken into the drainage lumen 11 of the catheter device 1 even if the amount of urine 310 in the bladder 300 is small.

The material of the retention section 20 is not particularly limited as long as it is expandable and contractible and has biocompatibility that allows it to expand and contract with a fluid. For example, materials similar to those used for the catheter body 10 and the balloon of a known balloon catheter can be used.

<Tip>
The distal tip 30 is disposed continuously from the distal end 21a of the arm portion 21 which is the distal end of the retention portion 20. By providing the distal tip 30, the catheter device 1 can suitably prevent damage or the like from occurring to a biological organ (such as an inner wall of a lumen) when the distal end comes into contact with the biological organ.

The tip 21a of the arm 21 is connected to the bottom 31 of the tip tip 30. The bottom 31 also has a recess 32 into which the tip 40a of the expansion/contraction section 40 can be attached and detached.

As shown in FIG. 4A, the distal tip 30 has an internal space 33 into which fluid can flow. The internal space 33 is in fluid communication with each of the expansion/contraction lumens 23 of the arm portion 21 through holes 34 formed in the bottom portion 31. There are no particular limitations on the shape or number of holes 34, but at least one hole should be provided for each arm portion 21.

The tip 30 has a communication hole 35 that connects the outer surface with the bottom 31. The communication hole 35 communicates with the inner cavity 10c of the catheter body 10. Therefore, when the catheter device 1 is delivered into the bladder 300, it is possible to confirm whether the tip 30 has reached the bladder 300 by checking the urine 310 discharged through the communication hole 35.

The distal tip 30 can be made of the same material as the catheter body 10. In addition, the distal tip 30 can be made of a material that is more flexible than the catheter body 10 to prevent damage to the inner wall of the blood vessel.

<Expansion/contraction section>
The expansion/contraction section 40 is composed of a long mandrel, and is operated when expanding and contracting the retention section 20. The expansion/contraction section 40 can be inserted into the distal end inside the catheter body 10 (specifically, through the opening 10d to the connection portion with the bottom portion 31 of the distal tip 30), and when the distal tip 30 is moved toward the proximal end by a pulling operation toward the proximal end, the distal portion 21a of the arm portion 21 moves toward the proximal end in response to this, expanding the retention section 20. When the expansion/contraction section 40 is pushed toward the distal end to move the distal tip 30 toward the distal end, the distal portion 21a of the arm portion 21 moves toward the distal end in response to this, contracting the retention section 20.

The distal end 40a of the expansion/contraction section 40 is fixed in a state of being fitted into the recess 32 of the distal tip 30, and the proximal end 40b is fixed to the hub 50. As a result, the axial movement of the expansion/contraction section 40 follows the axial movement of the hub 50. Therefore, when the catheter device 1 moves the retention section 20 in the axial direction of the hub 50 after delivering the retention section 20 into the bladder 300, the arm section 21 can be deformed from outside the body to expand and contract. Note that if each arm section 21 of the retention section 20 is preformed so that it can maintain an expanded state when inflated with a fluid, the expansion/contraction section 40 can be detachable from the recess 32 of the distal tip 30 and can be configured to be pulled out of the body when the retention section 20 is expanded.

There are no particular limitations on the material that makes up the expansion/contraction section 40, as long as it is a material that has the rigidity to allow the distal tip 30 to move axially when the retention section 20 expands and contracts.

<Hub>
The hub 50 is configured to be connectable to a connector known in the medical field (such as a Y connector) and allows urine to be discharged into a urine collection bag through a urine collection tube connected via the connector. A tip opening 51 of the hub 50 is connected to the base end 10b of the catheter main body 10, and the outlet lumen 11 communicates with the tip opening 51 of the hub 50. As a result, urine 310 flowing in from the outlet 12 can flow through the outlet lumen 11 and be discharged outside the living body from the tip opening 51 of the hub 50.

As shown in Figures 1 and 2, the hub 50 is configured to be movable in the axial direction relative to the catheter body 10. Since the base end 40b of the expansion/contraction section 40 is fixed to the hub 50, the expansion/contraction section 40 can be pulled and pushed in the axial direction by sliding the hub 50 in the axial direction.

<Sensor section>
The sensor unit 60 acquires predetermined biological information. As shown in FIG. 3A, the sensor unit 60 is arranged so as to overlap the position of the base end 22b of the slit 22 in the radial direction when viewed from the axial direction. The sensor unit 60 can be configured with at least one or more sensors of an oxygen sensor 61, a temperature sensor 62, or a flow rate sensor 63. The sensor unit 60 is not limited to the above-mentioned sensors, and can be configured to include sensors capable of acquiring the desired biological information, such as an optical sensor, an ultrasonic sensor, a pressure sensor, a flow rate sensor, an acceleration sensor, a conductivity sensor, and a biomarker sensor.

The oxygen sensor 61 is configured as a known fluorescent (optical) oxygen sensor, and is configured to emit fluorescence of an intensity corresponding to the oxygen concentration contained in the urine 310 when irradiated with excitation light. The oxygen sensor 61 has an oxygen sensor body 61a that measures the oxygen contained in the urine 310, and an oxygen transmission part 61b that can be optically connected to the oxygen sensor body 61a.

A measuring unit 61c capable of optically measuring oxygen in urine 310 is disposed at the tip of oxygen sensor body 61a. As shown in FIG. 1, measuring unit 61c is composed of optically transparent substrate 61d and phosphor 61e applied to substantially the entire surface of one side of substrate 61d.

As shown in FIG. 3A, the oxygen sensor body 61a is disposed such that the measuring part 61c at the tip faces the outlet 12 side, and a part of the measuring part 61c is embedded in the wall part 13a so that at least the measuring part 61c is exposed in the outlet lumen 11. As shown in FIG. 3A, the oxygen sensor body 61a is disposed such that the measuring part 61c located at the tip and the position of the base end 22b of the slit 22 overlap in the radial direction when viewed from the axial direction. As a result, the urine 310 flowing into the outlet lumen 11 along the slit 22 flows from the base end 22b of the slit 22 to the measuring part 61c located below it, as shown in FIG. 5. Therefore, the oxygen sensor body 61a efficiently comes into contact with the urine 310 flowing along the base end 22b of the slit 22, and therefore the oxygen partial pressure of the urine 310 can be measured with high accuracy without waiting for a certain amount of urine to be stored after it flows into the bladder 300.

The oxygen sensor 61 is preferably positioned along the inner surface of the outlet lumen 11 directly below the base end 22b of the slit 22 so that it can efficiently come into contact with the urine 310 flowing in along the base end 22b.

The oxygen sensor body 61a may be arranged so that the tip surface (measurement section 61c) is inclined in a direction intersecting the axial direction with respect to the outlet 12, as long as at least the measurement section 61c is arranged so that it radially overlaps the base end 22b of the slit 22 when viewed from the axial direction. The oxygen sensor body 61a may be arranged so that it radially overlaps the position of the base end 22b of the slit 22 when viewed from the axial direction, and so that it axially overlaps the position of the base end 22b of the slit 22 when viewed from the radial direction.

The oxygen transmission section 61b is made of an optical fiber and is optically connected to the measurement section 61c of the oxygen sensor main body 61a. The oxygen transmission section 61b is capable of irradiating the phosphor 61e with excitation light and receiving fluorescence from the phosphor 61e, and is fixed to the sensor lumen 13 with its tip surface positioned relative to the phosphor 61e. The oxygen transmission section 61b irradiates the phosphor 61e with excitation light from the light source section 220 described below, and transmits the fluorescence emitted by the phosphor 61e excited by the excitation light to the light receiving section 231 of the photoelectric conversion section 230. The base end of the oxygen transmission section 61b is connected to the cable connector 211 via the first branch section 14.

The temperature sensor 62 is capable of measuring the temperature inside the bladder 300, and more specifically, measures the temperature of the urine 310 inside the bladder 300. The temperature sensor 62 may measure the temperature of the urine 310 flowing through the outlet lumen 11. The temperature sensor 62 has a temperature sensor body 62a that measures the temperature of the urine 310, and a temperature transmission unit 62b that can be electrically connected to the temperature sensor body 62a.

The temperature sensor body 62a is composed of a device capable of measuring temperature, such as a thermocouple, a resistance thermometer, or a thermistor, and is housed in the sensor lumen 13 while being fixed to the outer peripheral surface of the tip of the oxygen transmission part 61b. Unlike the oxygen sensor body 61a, the temperature sensor body 62a is preferably arranged so that its tip or tip surface is not exposed to the discharge lumen 11, i.e., not in direct contact with the urine 310. Alternatively, the temperature sensor body 62a may be arranged on the proximal side of the oxygen sensor body 61a so that its tip or tip surface is not exposed to the discharge lumen 11. More specifically, the temperature sensor body 62a may be arranged on the proximal side of the oxygen sensor body 61a, adjacent to the oxygen sensor body 61a in a direction perpendicular to the central axis C of the catheter device 1, and so that its tip or tip surface is not exposed to the discharge lumen 11. This allows the temperature sensor 62 to be accommodated in a liquid-tight manner in the sensor lumen 13 separate from the outlet lumen 11, preventing urine 310 from flowing into the sensor lumen 13 and preventing breakdown of the sensor unit 60, electric shock, etc. The temperature sensor body 62a is capable of measuring the temperature inside the bladder 300 and measures the temperature of the urine 310 in the bladder 300. The temperature sensor body 62a may measure the temperature of the urine 310 flowing through the outlet lumen 11. Two or more temperature sensor bodies 62a may be provided in the sensor lumen 13, and by providing two or more temperature sensor bodies 62a, for example, a heater may be provided between the two temperature sensor bodies 62a, and the temperature sensor 62 can be used as a thermal flow meter.

The temperature transmission part 62b is electrically connected to the temperature sensor body 62a and transmits an electrical signal based on the temperature value of the urine 310 measured by the temperature sensor body 62a to the outside (control part 240). The temperature transmission part 62b is fixed to the outer peripheral surface of the oxygen transmission part 61b, and the base end is connected to the cable connector 211 via the first branch part 14.

The flow rate sensor 63 is composed of a flow rate sensor body 63a capable of measuring the amount of urine, and a flow rate transmission part 63b electrically connectable to the flow rate sensor body 63a. The flow rate sensor 63 is provided, for example, on the wall surface on the base end side of the outlet lumen 11 so that the flow rate sensor body 63a and the urine 310 come into contact with each other, so that the amount of urine flowing through the outlet lumen 11 can be measured. The base end of the flow rate transmission part 63b is connected to the cable connector 211 via the first branch part 14. The position of the flow rate sensor body 63a is not limited as long as it is in a position where it can come into contact with the urine 310. For example, the flow rate sensor body 63a may be provided near the outlet 12 so that the flow rate sensor body 63a and the urine 310 come into contact with each other, or may be provided in the outlet lumen 11 on the base end side of the hub 50.

As shown in Figures 6A to 6C, the catheter device 1 can be provided with additional structure for properly expanding the retention section 20.

As shown in Figs. 6A and 6B, the retention section 20 can be configured to have an expansion guide section 24 for expanding the arm section 21 by promoting the deformation of the arm section 21 radially outward. As shown in Figs. 6A and 6B, the expansion guide section 24 can be configured with at least one of a recess 24a formed on the outer peripheral surface of the arm section 21, or a narrow section 24b that is narrower than the base end of the arm section 21. The expansion guide section 24 promotes the expansion by promoting the deformation of the arm section 21 radially outward as the expansion/contraction section 40 moves in the axial direction.

As shown in FIG. 6C, the bottom 31 of the tip tip 30 has an outer periphery 31a connected to the tip 21a of the arm 21 and is also connected to the expansion/contraction section 40. As the expansion/contraction section 40 moves in the axial direction, the outer periphery 31a of the bottom 31 deforms and tilts outward in the axial direction, inducing the deformation of the arm 21 radially outward to promote expansion. Note that, from the viewpoint of promoting the expansion of the retention section 20, the bottom 31 can also be shaped so that the outer periphery 31a is always tilted outward in the axial direction regardless of the movement of the expansion/contraction section 40.

The catheter device 1 is configured with an expansion guide section 24 on the arm section 21 and can properly expand the arm section 21 radially outward by deforming the bottom section 31 of the distal tip 30, so that the catheter device 1 can effectively prevent the retention section 20 from unintentionally falling off.

Although it has been stated that the catheter device 1 can have four arm portions 21 spaced equally apart in the circumferential direction, the number of arm portions 21 is not limited to four, and as a modified example, the number of arm portions 21 can be changed.

Figure 7A shows a modified example of the catheter device 1 in which the number of arm portions 21 of the retention section 20 is three, and Figure 7B shows the retention section 20 of Figure 7A in an expanded state. Figure 8A shows another modified example of the catheter device 1 in which the number of arm portions 21 of the retention section 20 is two, and Figure 8B shows the retention section 20 of Figure 8A in an expanded state. In this way, by reducing the number of arm portions 21 from the above-mentioned configuration, the catheter device 1 can increase the width of each arm portion 21 and increase the holding power when retained.

[motion]
Next, the operation of the catheter device 1 during placement will be described with reference to FIGS. 9A to 9D as appropriate.

As shown in FIG. 9A, the surgeon inserts the catheter device 1 from the external urethral orifice and delivers the retention portion 20 into the bladder 300.

Next, the surgeon pulls the expansion/contraction section 40 toward the base end, moving the distal tip 30 toward the base end. As shown in FIG. 9B, the arm section 21 of the retention section 20 expands radially outward by pulling the expansion/contraction section 40.

Then, as shown in FIG. 9C, the surgeon injects fluid from the second branch 15 to expand the arm 21. At this time, the fluid flowing through the fluid lumen 16 flows into the expansion/contraction lumen 23 that communicates with the fluid lumen 16, flows into the internal space 33 of the distal tip 30, and then fills the expansion/contraction lumen 23 of each arm 21 through the hole 34.

When the surgeon confirms the expansion and inflation of the retention portion 20, the retention portion 20 of the catheter device 1 is retained in the bladder 300 as shown in FIG. 9D, and the retention process of the catheter device 1 is completed. After the catheter device 1 is retained, urine 310 in the bladder 300 flows in through the opening 22c of the slit 22, flows down the slit 22 into the sensor portion 60 and the outlet 12, and is led outside the body via the outlet lumen 11.

As described above, the catheter device 1 according to the first embodiment includes a long catheter body 10, an outlet lumen 11 that leads urine 310 in the bladder 300 to the outside of the living body, an outlet port 12 that communicates with the outlet lumen 11, a sensor lumen 13 that is arranged parallel to the outlet lumen 11 and that houses a sensor unit 60, a retention section 20 that is retained in the bladder 300, an expansion and contraction section 40 that expands and contracts by deforming the arm section 21 by axial movement of the arm section 21, and a sensor section 60 that acquires biological information. The retention section 20 includes a plurality of expandable and contractible arm sections 21 that extend from the vicinity of the outlet port 12 to the tip side, and a plurality of slits 22 formed between adjacent arm sections 21 in the circumferential direction. The sensor section 60 is arranged near the outlet port 12 so as to overlap the base end 22b of the slit 22 in the radial direction when viewed from the axial direction.

Because the catheter device 1 has the above configuration, the urine 310 in the bladder 300 flows from the opening 22c formed when the arm portion 21 is expanded through the base end 22b of the slit 22 into the outlet lumen 11, so that the urine 310 can be discharged sequentially. In addition, the sensor unit 60 is disposed near the outlet 12 so as to overlap radially with the base end of the slit 22 when viewed from the axial direction, so that it can come into contact with the urine 310 that has flowed into the outlet 12 through the base end 22b of the slit 22. The oxygen partial pressure of the urine 310 changes over time, but the catheter device 1 can measure the urine 310 in the bladder 300 sequentially, so that the oxygen partial pressure of the urine 310 can be measured with high accuracy.

[Medical System]
Next, a description will be given of a medical system 200 including the above-mentioned catheter device 1. As shown in Fig. 10, the medical system 200 is configured by electrically and optically connecting the catheter device 1 to a measuring device 210, which is an external device including a photoelectric conversion unit 230, a control unit 240, an input unit 250, and an operation display unit 260.

The measuring device 210 is electrically and optically connected to the catheter device 1 via a long transmission cable 212 connected to a cable connector 211. The cable connector 211 is connected to the oxygen transmission section 61b, the temperature transmission section 62b, and the flow rate transmission section 63b. The transmission cable 212 is a combination of an optical fiber (light guide 221) that can be optically connected to the oxygen transmission section 61b, and an electric wire that can be electrically connected to the temperature transmission section 62b and the flow rate transmission section 63b, and extends to the measuring device 210.

<Light source section>
The light source unit 220 is, for example, a light emitting diode, and emits excitation light of a predetermined wavelength to the oxygen transmission unit 61b. The light source unit 220 is connected to the cable connector 211 via a light guide path 221. The light emitted by the light source unit 220 contains almost no wavelength of the fluorescence emitted by the phosphor 61e. When the light emitted by the light source unit 220 contains the wavelength of the fluorescence emitted by the phosphor 61e, or when it is desired to set the wavelength of the excitation light to an accurate excitation wavelength, an optical filter may be disposed.

<Photoelectric conversion unit>
The photoelectric conversion unit 230 includes a light receiving unit 231 and an A/D conversion unit 232. The light receiving unit 231 is, for example, a photodiode, and receives the fluorescence transmitted from the oxygen transmission unit 61b. The A/D conversion unit 232 converts the light receiving signal of the light receiving unit 231 into a digital signal (digital value) and outputs it to the control unit 240.

<Control Unit>
The control unit 240 has a storage unit 241, an analysis unit 242, and a process control unit 243. The control unit 240 also includes a temperature input unit (not shown) to which an output signal of the temperature sensor 62 is input, and a flow velocity input unit (not shown) to which an output signal of the flow velocity sensor 63 is input.

The control unit 240 has various function realization units. The function realization units are software function units whose functions are realized by the CPU (central processing unit) executing the programs stored in the memory unit 241, but they can also be realized by hardware function units consisting of integrated circuits such as FPGAs (field-programmable gate arrays).

The memory unit 241 has a writable non-volatile memory (e.g., a flash memory) and can store information input via the operation display unit 260 and information calculated by the control unit 240.

The analysis unit 242 includes an oxygen partial pressure calculation unit 242a, a urine volume calculation unit 242b, a flow rate calculation unit 242c, a flow rate determination unit 242d, a urine volume condition setting unit 242e, and a urine volume determination unit 242f. The analysis unit 242 performs a predetermined analysis process based on the biological information acquired by the sensor unit 60.

The oxygen partial pressure calculation unit 242a calculates the oxygen partial pressure in the urine based on the output signal of the oxygen sensor 61 and the output signal of the temperature sensor 62. The urine volume calculation unit 242b calculates the urine volume based on the output signal of the flow velocity sensor 63. The flow velocity calculation unit 242c calculates the flow velocity V of the urine 310 in the derivation lumen 11 based on the output signal from the flow velocity sensor 63.

The urine volume condition setting unit 242e sets a predetermined urine volume condition. Specifically, the urine volume condition setting unit 242e sets a first urine volume judgment value and a second urine volume judgment value. The first urine volume judgment value is calculated, for example, by multiplying a first urine volume reference value (0.5 ml/kg/h) used to judge the first and second stages of acute kidney injury (AKI) by the patient's weight. The second urine volume judgment value is calculated by multiplying a second urine volume reference value (0.3 ml/kg/h) used to judge the third stage of acute kidney injury by the patient's weight. However, the urine volume condition setting unit 242e can set any condition. The urine volume judgment unit 242f judges whether the urine volume calculated by the urine volume calculation unit 242b matches a predetermined urine volume condition.

The process control unit 243 transmits the various analysis results analyzed by each part of the analysis unit 242 to a predetermined communication destination and performs predetermined process control. Data transmitted from the process control unit 243 is converted into a data format that can be processed by the communication destination and transmitted. For example, when transmitting display data that can be displayed on the operation display unit 260 as the communication destination, the process control unit 243 can transmit display data that changes the display format of the oxygen partial pressure according to the flow velocity V of the urine 310 acquired based on the output signal of the flow velocity sensor 63, thereby controlling the display of the operation display unit 260.

In addition, when the communication destination is a terminal capable of wired or wireless communication, such as a mobile terminal (smartphone, tablet terminal, mobile phone, etc.) or an external terminal such as a PC (including an external management server, etc.), the processing control unit 243 can generate transmission data based on the analysis results of each part of the control unit 240 and add a network interface function that can transmit the data to the communication destination via a specified communication network.

<Input section>
The input unit 250 is configured with a mechanical switch such as a push button that issues an instruction to start or stop monitoring. The input unit 250 is operated when starting or stopping measurement of the oxygen partial pressure in urine. The measuring device 210 is also provided with a power button (not shown) and the like.

<Operation display section>
The operation display unit 260 is configured to be able to display the analysis results (calculated oxygen partial pressure in urine, etc.) analyzed by the control unit 240. The operation display unit 260 is composed of a display device such as a liquid crystal display or an inorganic/organic EL display. The operation display unit 260 has a touch panel function and also functions as an input unit for inputting predetermined information to the measuring device 210. The input format by the operation display unit 260 can be a pointing device such as a mouse cursor type, a touch pen type, or a touch pad type in addition to the touch panel type. Note that the input of information to the measuring device 210 is not limited to the input by the operation display unit 260, and can also be input from various input devices such as a numeric keypad or keyboard (not shown).

In this way, the medical system 200 can analyze various types of bioinformation acquired by the catheter device 1 placed in a living body such as the bladder 300, and transmit the analysis results to a predetermined communication destination such as the operation display unit 260 or a mobile terminal. Therefore, medical staff such as doctors and nurses can keep track of the patient's vital signs based on the highly accurate bioinformation acquired by the catheter device 1.

The medical system 200 can also be modified as follows. Note that configurations and the like that are not specifically mentioned in the description of the modified examples can be the same as the configurations and functions of the medical system 200 described above.

Figure 11 shows a block diagram outlining the modified parts of a modified medical system 200A having multiple fluorescent sensors, and Figure 12 shows a diagram illustrating the positions of two or more fluorescent sensors 611, 612 having fluorescent materials that react to oxygen in urine. Note that in medical system 200A, other system configurations not shown in Figure 11 are similar to the configuration of medical system 200 described above (see Figure 10).

The medical system 200A differs from the medical system 200 described above in that the fluorescence emitted from the multiple types of phosphors 61e arranged in the oxygen sensor 61 is received by a single oxygen transmission section 61b, and is then dispersed by the measuring device 210 to analyze the fluorescence from each sensor, thereby making it possible to obtain multiple parameters.

In the modified medical system 200A, the photoelectric conversion unit 230A of the measurement device 210A includes a first beam splitter 233, a second beam splitter 234, and two fluorescence detection units, a first fluorescence detection unit 235 and a second fluorescence detection unit 236. The first fluorescence detection unit 235 and the second fluorescence detection unit 236 are connected to the same control unit 240.

The light source unit 220A is connected to the first beam splitter 233 via the light guide path 221. The first beam splitter 233 is connected to the cable connector 211 via the light guide path 221. The second beam splitter 234 is connected to the first beam splitter 233 via the light guide path 221.

The first fluorescence detection unit 235 and the second fluorescence detection unit 236 are each connected to the second beam splitter 234 via the light guide path 221. The second beam splitter 234 is a dichroic beam splitter that optically separates the incident light based on wavelength.

The two fluorescent sensors 611, 612 are connected to the measuring device 210A. One fluorescent sensor 611 has a first fluorescent material 611e. The other fluorescent sensor 612 has a second fluorescent material 612e. The first fluorescent material 611e and the second fluorescent material 612e react to different components in urine and emit fluorescence of different wavelengths. One fluorescent sensor 611 (or fluorescent sensor 612) may contain the first fluorescent material 611e and the second fluorescent material 612e, or each of the fluorescent sensors 611, 612 may have a different fluorescent material.

As shown in FIG. 12, the two fluorescent sensors 611, 612 are arranged so that at least the measurement portion at the tip is exposed inside the extraction lumen 11, and further, when viewed from the axial direction, the tip overlaps the position of the base end 22b of the slit 22 in the radial direction. The slits 22 and the fluorescent sensors 611, 612 are arranged in a one-to-one relationship. Note that there is no particular limit to the number of fluorescent sensors arranged for a slit 22, and multiple fluorescent sensors can be arranged along the radial direction for one slit 22.

The light source unit 220A emits excitation light that excites both the first phosphor 611e and the second phosphor 612e. The excitation light emitted from the light source unit 220A irradiates the first phosphor 611e and the second phosphor 612e via the light guide 221, the first beam splitter 233, and the oxygen transmission unit 61b. The first phosphor 611e and the second phosphor 612e each emit fluorescence when in contact with urine 310.

The fluorescence enters the first beam splitter 233 via the oxygen transmission section 61b and the light guide 221. The first beam splitter 233 causes the fluorescence to enter the light guide 221 leading to the second beam splitter 234. The second beam splitter 234 separates the fluorescence into the fluorescence emitted by the first phosphor 611e and other light. The fluorescence emitted by the first phosphor 611e enters the first fluorescence detection section 235, and the other light enters the second fluorescence detection section 236. The second beam splitter 234 functions as a spectroscopic section that separates the fluorescence obtained from the multiple fluorescent sensors 611, 612.

The first fluorescence detection unit 235 and the second fluorescence detection unit 236 convert the incident light into an electrical signal and output it to the control unit 240. The control unit 240 analyzes the input electrical signal with the analysis unit 242 to obtain a plurality of parameters (e.g., partial pressure of oxygen in urine, Na, K, pH, urine specific gravity, Cr, _pCO2 , _SpO2 , pressure, temperature, flow rate, etc.) corresponding to each of the fluorescent sensors 611, 612.

In this way, the modified medical system 200A uses multiple fluorescent sensors 611, 612 to disperse and then analyze the fluorescence detected by each sensor, making it possible to obtain, for example, oxygen partial pressure and other specified parameters. In addition, since the fluorescent sensors 611, 612 are arranged one-to-one at the base end 22b of the slits 22, various parameters can be measured with high accuracy from the urine 310 that has flowed through each slit 22.

Next, the second to fifth embodiments, which are modified examples of the catheter device according to the present invention, will be described. In the following description of each embodiment, differences from the previously described embodiments will be mainly described, and components having equivalent functions to other embodiments will be denoted with the same or related reference numerals, detailed description will be omitted, and no special mention will be made. Furthermore, the configuration, members, and method of use may be the same as those of each embodiment. Furthermore, the embodiments shown in the first to fifth embodiments may be combined in any manner without departing from the spirit of the present invention.

[Second embodiment]
A catheter device 1A according to a second embodiment will be described with reference to FIGS. 13A and 13B.

The catheter device 1A of the second embodiment differs from the other embodiments in the configuration of the expansion/contraction section 40A.

As shown in Figures 13A and 13B, the catheter device 1A includes a long catheter body 10A, a retention section 20A disposed at the distal end of the catheter body 10A, a distal tip 30A disposed at the distal end of the retention section 20A, an expansion/contraction section 40A that expands and contracts the retention section 20A, a hub 50A attached to the proximal end 10b of the catheter body 10A, and a sensor section 60A that acquires biological information.

Figure 13A shows the state of the catheter device 1A of the second embodiment when it is inserted and removed, and Figure 13B shows the state of the catheter device 1A of the second embodiment when it is placed in place. As shown in Figure 13A, the arm portion 21 of the placement section 20 of the catheter device 1A is contracted when it is inserted and removed, and as shown in Figure 13B, the arm portion 21 of the placement section 20 is expanded when it is placed in place.

The catheter body 10A is configured such that a portion of the base end side can be separated in the axial direction. The catheter body 10A has a separation section 10Aa that can approach and separate in the axial direction. The separation section 10Aa is connected to the hub 50A. The contact surface 10Ab of the catheter body 10A against the separation section 10Aa and the contact surface 10Ac of the separation section 10Aa against the catheter body 10A both face each other in the axial direction. As shown in FIG. 13A, the contact surface 10Ab and the contact surface 10Ac come into contact with each other during insertion and removal, and as shown in FIG. 13B, when the device is indwelled, the surfaces move relative to each other in the axial direction and are separated from each other. As shown in FIG. 13B, an expansion tube 70 is attached between the contact surface 10Ab and the contact surface 10Ac to fill the gap between them.

The expansion tube 70 is a removable member that fills the gap between the contact surface 10Ab of the catheter body 10A and the contact surface 10Ac of the separation portion 10Aa when the retention portion 20A is expanded. The axial length of the expansion tube 70 is set according to the distance between the contact surface 10Ab and the contact surface 10Ac when they are separated (i.e., the amount of movement of the expansion/contraction portion 40 when the retention portion 20A is expanded).

The expansion tube 70 is attached between the contact surface 10Ab and the contact surface 10Ac after the retention portion 20A is expanded, and is fixed by the fixing device 80. The shape of the fixing device 80 can be designed arbitrarily as long as it has a configuration that engages with the catheter body 10A and the separation portion 10Aa and can prevent the expansion tube 70 from unintentionally falling off during use.

The expansion/contraction section 40A can be inserted into the catheter body 10A up to the tip (specifically, through the opening 10d to the connection with the bottom 31 of the tip tip 30A), and the tip is connected to the arm section 21 so that it can move axially. The expansion/contraction section 40A is composed of a long hollow pipe having an inner cavity 41, with the tip 40a connected to the bottom 31 of the tip tip 30A and the base end 40b connected in communication with the tip opening 51 of the hub 50A.

The expansion and contraction section 40A is formed with an outlet 12 that guides urine 310 in the bladder 300 to the lumen 41. The lumen 41 has a base end that communicates with the tip opening 51 of the hub 50, and functions as an outlet lumen 11 that guides the urine 310 that flows in from the outlet 12 to the hub 50.

The expansion/contraction section 40A moves the distal tip 30A in the axial direction by moving the connected hub 50 in the axial direction, and expands and contracts the arm section 21 of the retention section 20A in response to this movement. When the expansion/contraction section 40A moves the distal tip 30A toward the base end by pulling it toward the base end, the distal end 21a of the arm section 21 moves toward the base end in response to this, expanding the retention section 20 (see FIG. 13B). When the retention section 20 is expanded, an expansion tube 70 is attached between the contact surface 10Ab of the catheter main body 10A and the contact surface 10Ac of the separation section 10Aa, and is fixed by a fixing device 80. When the expansion/contraction section 40A moves the distal tip 30A toward the distal end by pushing it toward the distal end, the distal end 21a of the arm section 21 moves toward the distal end in response to this, contracting the retention section 20 (see FIG. 13A).

As shown in FIG. 13A, the outlet 12 is located away from the opening 10d of the catheter body 10A toward the axial tip side during insertion and removal, and as shown in FIG. 13B, during placement, it moves to the vicinity of the opening 10d of the catheter body 10A as the expansion/contraction section 40A moves toward the base end. The outlet 12 is formed so as to open toward the sensor section 60 in the radial direction.

When the expansion/contraction section 40A is operated during expansion of the arm section 21, the outlet 12 moves from the position before expansion toward the base end side in the axial direction to near the tip of the catheter body 10. As shown in FIG. 11C, urine 310 flows into the outlet 12 while coming into contact with the sensor section 60A as it flows along the base end 22b of the slit 22 of the retention section 20A. Note that the urine 310 may flow partially into the lumen 10c from the opening 10d of the catheter body 10 along the slit 22, but since the base end 10b of the catheter body 10 is connected to the hub 50 through the lumen 10c, it is discharged outside the living body through the hub 50. Note that the lumen 10c may be made liquid-tight to prevent the urine 310 from flowing partially into the lumen 10c from the opening 10d of the catheter body 10 along the slit 22. A structure that fills the opening 10d may be provided as a structure that keeps the lumen 10c liquid-tight.

The flow velocity sensor 63 of the sensor unit 60A is positioned at a position where the flow velocity V of the urine 310 flowing through the lumen 41 of the expansion/contraction unit 40A can be measured.

As described above, the catheter device 1A of the second embodiment can use a hollow pipe instead of the mandrel of the first embodiment as the configuration of the expansion/contraction section 40A. In the catheter device 1A, the outlet 12 moves to near the base end 22b of the slit 22 when the retention section 20 is expanded, so that urine 310 that flows from the outlet 12 along the base end 22b of the slit 22 flows into the sensor section 60A located near the outlet 12. Therefore, the catheter device 1A can measure oxygen partial pressure with high accuracy.

[Third embodiment]
A catheter device 1B according to a third embodiment will be described with reference to FIGS. 14A and 14B.

The catheter device 1B of the third embodiment differs from the other embodiments in the arrangement of the arm portion 21 and the shape of the expansion/contraction portion 40B.

As shown in Figures 14A and 14B, the catheter device 1B includes a long catheter body 10B, a retention section 20B disposed at the distal end of the catheter body 10B, a distal tip 30B disposed at the distal end of the retention section 20B, an expansion/contraction section 40B that expands and contracts the retention section 20B, and a sensor section 60B that acquires biological information.

The side of the catheter body 10B is formed with an engagement groove 17 extending in the axial direction, in which the expansion/contraction section 40B can slide. The engagement groove 17 extends parallel to the sensor lumen 13 and is positioned eccentrically on the side facing the arm section 21 with respect to the central axis C. The expansion/contraction section 40B engages with the engagement groove 17 so as to be slidable in the axial direction.

The arm portion 21 of the retention portion 20B is eccentrically positioned on the side facing the sensor portion 60B in the radial direction with respect to the central axis C. As shown in FIG. 14C, the arm portion 21 can be positioned at equal intervals at the tip of the catheter main body 10B, eccentrically positioned on the side facing the sensor portion 60B in the radial direction with respect to the central axis C. In addition, in the catheter device 1B, since a sufficient opening 22c is secured between the expansion/contraction portion 40B and the slit 22, the positional relationship between the sensor portion 60B and the base end 22b of the slit 22 may be such that they overlap in the radial direction. In other words, the sensor portion 60B may be positioned near the base end 22b of the slit 22.

The number of arm portions 21 formed is not limited to three, but may be at least two or more.

The expansion/contraction section 40B is composed of a long member that also serves as the outer peripheral surface and thick portion of the catheter body 10B. The expansion/contraction section 40B is positioned eccentrically on the side facing the arm section 21 with respect to the central axis C based on the eccentric position of the arm section 21.

The tip 40a of the expansion/contraction section 40B is connected to the bottom 31 of the tip tip 30B, and supports the tip tip 30B while guiding its movement along the axial direction. The base end 40b of the expansion/contraction section 40B extends to the vicinity of the base end 10b of the catheter body 10B. The expansion/contraction section 40B is slidably engaged with an engagement groove 17 formed in the catheter body 10B. The expansion/contraction section 40B may be provided with an operating protrusion or the like on the base end side to facilitate the expansion and contraction of the retention section 20.

The expansion/contraction section 40B has a fluid lumen 16 formed therein. The distal end of the fluid lumen 16 communicates with the bottom 31 of the distal tip 30, and the proximal end communicates with the second branch section 15.

When the catheter device 1B expands the retention portion 20B, the expansion/contraction portion 40B is pulled toward the base end along the engagement groove 17, and the arm portion 21 expands by bending radially outward as the distal tip 30B moves toward the base end (see FIG. 14B). When the catheter device 1B contracts the retention portion 20B, the expansion/contraction portion 40B is pushed toward the distal end, and the arm portion 21 returns to its original shape and contracts as the distal tip 30B moves toward the distal end (see FIG. 14A).

As described above, in the catheter device 1B of the third embodiment, the expansion/contraction section 40B and the sensor section 60B are arranged on opposite sides of the central axis C, and accordingly, the expansion/contraction section 40B, which is arranged eccentrically on the outer peripheral surface side of the catheter body 10B according to the eccentric position of the sensor lumen 13 and the arm section 21 that house the sensor section 60B, can be concentrated at a predetermined location in the thick part of the catheter body 10B. Therefore, as shown in FIG. 14C, the catheter device 1B can expand the opening area of the outlet lumen 11, so that even in patients with a large amount of urine, urine can be discharged successively without being stored in the bladder 300.

[Fourth embodiment]
A catheter device 1C according to a fourth embodiment will be described with reference to FIGS. 15A and 15B.

The fourth embodiment of the catheter device 1C differs from the other embodiments in the shape of the slit 22.

As shown in Fig. 15A, the catheter device 1C has a slit 22 in the retention section 20C that is twisted in the axial direction when the arm section 21 is contracted. In the process from the tip 22a to the base end 22b, the slit 22 extends in the axial direction for a predetermined distance from the tip 22a, then twists in the axial direction midway, and extends again in the axial direction to reach the base end 22b.

When the catheter device 1C expands the retention section 20C, the expansion/contraction section 40C is pulled toward the base end, and the arm section 21 is bent radially outward and expanded as the distal tip 30C moves toward the base end. At this time, as shown in FIG. 15B, the arm section 21 is formed with the slit 22 twisted in the axial direction, so that the amount of movement of the distal tip 30C toward the base end is reduced compared to other embodiments, and the opening area of the opening 22c is enlarged. In other words, the catheter device 1C has a smaller amount of movement during expansion compared to other embodiments, and the radial size of the retention section 20C during expansion is larger.

When contracting the retention section 20 of the catheter device 1C, the expansion/contraction section 40C is pushed toward the distal end, and the arm section 21 returns to its original shape and contracts as the distal tip 30C moves toward the distal end. In this case, too, the slit 22 is twisted in the axial direction, so the amount of movement toward the base end is shorter than in other embodiments, reducing the amount of movement of the distal tip 30C.

As described above, in the catheter device 1C of the fourth embodiment, the slit 22 is formed so as to be twisted in the axial direction, so that the amount of axial movement of the distal tip 30C is reduced. Therefore, the catheter device 1C can prevent the bladder 300 from being unexpectedly compressed or pushed in by the movement of the distal tip 30C during the expansion and contraction operation of the retention section 20C. In addition, in the catheter device 1C, the opening area of the opening 22c is enlarged by forming the slit 22 so as to be twisted in the axial direction, so that the urine 310 can easily flow into the sensor section 60C and can be discharged smoothly.

[Fifth embodiment]
A catheter device 1D according to a fifth embodiment will be described with reference to FIG.

The catheter device 1D of the fifth embodiment differs from the other embodiments in the structure for effectively directing urine 310 to the outlet lumen 11 on the proximal side of the slit 22.

In the catheter device 1D, a membrane portion 90 is formed on the base end side of the slit 22 so as to connect adjacent arm portions 21 in the circumferential direction. The membrane portion 90 can be made of a flexible and deformable material such as a silicone membrane.

The membrane portion 90 can be formed in at least one of the slits 22 in which the base end 22b of the slit 22 does not overlap the sensor portion 60D in the radial direction when viewed from the axial direction. If the membrane portion 90 is formed in a slit 22 in which the base end 22b of the slit 22 and the sensor portion 60 overlap in the radial direction when viewed from the axial direction, it is not preferable because the membrane portion 90 is located above the sensor portion 60, making it difficult for the urine 310 to contact the sensor portion 60. On the other hand, if the membrane portion 90 is formed in a slit 22 in which the base end 22b of the slit 22 and the sensor portion 60 do not overlap in the radial direction when viewed from the axial direction, the urine 310 that has flowed in through the other slits 22 can be easily guided to the outlet lumen 11 or the sensor portion 60D without impeding the flow of the urine 310 into the sensor portion 60, and the urine 310 can be efficiently discharged.

The formation area of the membrane portion 90 is on the base end side of the slit 22, and is preferably 50% or less of the total length of the slit 22 when the arm portion 21 is contracted so as not to impede the discharge of urine 310.

The number of membrane portions 90 formed is not particularly limited, and the base ends 22b of the slits 22 may be arranged alternately in the circumferential direction among the slits 22 that do not radially overlap the sensor portion 60D when viewed from the axial direction, or may be arranged in all symmetrical slits 22.

As described above, the catheter device 1D of the fifth embodiment has at least one slit 22 formed on the base end side of the slit 22 where the base end 22b does not radially overlap with the sensor unit 60D when viewed from the axial direction, so that the flow of urine 310 into the sensor unit 60D is not impeded. In addition, the membrane unit 90 makes it easier to guide the urine 310 that has flowed through the slit 22 to the outlet lumen 11 or the sensor unit 60D, so that the urine 310 can be efficiently discharged.

[Action and Effect]
As described above, the catheter device 1 according to this embodiment is a device having a retention section 20 to be retained inside a living body, and the retention section 20 has a plurality of arm sections 21 that can expand and contract, and the arm sections 21 are composed of a tubular body that can expand and contract as fluid flows in and out.

With this configuration, when the retention section 20 is retained inside the living body (e.g., inside the bladder 300), the arm section 21 expands and then expands with the fluid, making it difficult for the retention section 20 to fall out of the retention position, thereby preventing unintended detachment from the living body.

In the catheter device 1 according to this embodiment, the arm portion 21 may be configured with an expansion guide portion 24 having at least one of a recess 24a formed on the outer peripheral surface of the arm portion 21 or a narrow portion 24b that is narrower than the base end of the arm portion 21 in order to promote radially outward deformation and expansion.

With this configuration, the arm portion 21 can be properly expanded radially outward by the action of the expansion guide portion 24, effectively preventing the retention portion 20 from unintentionally falling off.

In the catheter device 1 according to this embodiment, the living body is a bladder 300, and the catheter device 1 has a long catheter body 10, an outlet lumen 11 that guides urine 310 in the bladder 300 to the outside of the living body, and an outlet port 12 that communicates with the outlet lumen 11, and the arm portion 21 may be configured to extend from near the outlet port 12 toward the tip side.

With this configuration, when the catheter device 1 is placed in the bladder 300, the arm portion 21 expands and then can be expanded by fluid, preventing unintended detachment from the bladder 300, and allowing the catheter device 1 to be used as a bladder indwelling catheter that can discharge urine 310 flowing in from the outlet 12 to the outside of the living body through the outlet lumen 11.

In the catheter device 1 according to this embodiment, the retention section 20 has a plurality of slits 22 formed between adjacent arm sections 21 in the circumferential direction, and the catheter device 1 may be configured to have a sensor section 60 for acquiring biological information that is disposed near the outlet 12 so as to radially overlap the base end 22b of the slits 22 when viewed in the axial direction.

With this configuration, urine 310 in the bladder 300 flows from the opening 22c formed when the arm portion 21 is expanded through the base end 22b of the slit 22 into the outlet lumen 11, so that the urine 310 can be discharged sequentially. In addition, the sensor portion 60 is disposed near the outlet 12 so as to overlap radially with the base end of the slit 22 when viewed from the axial direction, so that it can come into contact with the urine 310 that has flowed into the outlet 12 through the base end 22b of the slit 22. When the oxygen partial pressure of the urine 310 is acquired as biological information, the oxygen partial pressure in the urine changes over time, but with the catheter device 1, the urine 310 in the bladder 300 can be measured sequentially, so that the oxygen partial pressure of the urine 310 can be measured with high accuracy.

In the catheter device 1 according to this embodiment, the catheter body 10 may be configured to be arranged parallel to the outlet lumen 11 and to have a sensor lumen 13 that houses the sensor unit 60.

This configuration allows the sensor unit 60 to be housed in a sensor lumen 13 separate from the discharge lumen 11, so it does not impede the discharge of urine 310. In addition, since urine 310 does not come into contact with any part of the sensor unit 60 other than the exposed part, it is possible to prevent breakdown of the sensor unit 60, electric shock, etc.

The catheter device 1 according to this embodiment may be configured to have an expansion/contraction section 40 that expands and contracts by deforming the arm section 21 as the arm section 21 moves in the axial direction. The expansion/contraction section 40 may be configured as a mandrel that can be inserted into the catheter body 10 up to its tip, with the tip section 40a connected to the arm section 21 so as to be movable in the axial direction, or may be configured as a hollow pipe that has an outlet 12 and an inner cavity 41 that communicates with the outlet 12 and functions as an outlet lumen 11, that can be inserted into the catheter body 10 up to its tip, with the tip section 40a connected to the arm section 21 so as to be movable in the axial direction.

With this configuration, the catheter device 1 can be expanded and contracted by deforming the arm portion 21 from outside the body based on the axial operation of the expansion/contraction portion 40 after the retention portion 20 is delivered into the bladder 300, thus simplifying the procedure.

The catheter device 1 according to this embodiment has a distal tip 30 disposed at the distal end of the retention section 20, and the distal tip 30 may be configured to have a communication hole 35 whose distal end communicates with the bladder 300 and whose proximal end communicates with the outlet lumen 11.

With this configuration, when the catheter device 1 is delivered into the bladder 300, it is possible to confirm whether the distal tip 30 has reached the bladder 300 by checking the urine 310 discharged through the communication hole 35.

In the catheter device 1 according to this embodiment, the distal tip 30 has a bottom 31 connected to the distal end 21a of the arm 21 and to the expansion/contraction section 40, and the bottom 31 may be configured such that the peripheral portion 31a is inclined outward in the axial direction and deforms as the expansion/contraction section 40 moves in the axial direction.

This configuration allows the arm portion 21 to properly expand radially outward in response to deformation of the bottom portion 31, thereby preventing the retention portion 20 from unintentionally falling off.

In the catheter device 1B according to this embodiment, the arm portion 21 may be configured to be positioned eccentrically on the side facing the sensor portion 60B in the radial direction with respect to the central axis C.

With this configuration, the sensor lumen 13 that houses the sensor portion 60B and the expansion/contraction portion 40B that is eccentrically positioned on the outer peripheral surface side of the catheter body 10B according to the eccentric position of the arm portion 21 can be concentrated at a predetermined location on the thick portion of the catheter body 10B. Therefore, since the opening area of the outlet lumen 11 of the catheter device 1B can be enlarged, even in patients with a large amount of urine, urine 310 can be discharged successively without accumulating in the bladder 300.

In the catheter device 1C according to this embodiment, the slit 22 may be configured to be twisted in the axial direction when the arm portion 21 is contracted.

With this configuration, the catheter device 1C reduces the amount of axial movement of the distal tip 30C, preventing the distal tip 30C from accidentally compressing or pushing against the bladder 300 when expanding and contracting the retention section 20C.

In the catheter device 1D according to this embodiment, the retention section 20D has a membrane section 90 formed on the base end side of the slit 22 so as to connect adjacent arm sections 21 in the circumferential direction, and the membrane section 90 may be configured to be formed in at least one of the multiple slits 22 whose base end 22b does not radially overlap with the sensor section 60D when viewed from the axial direction.

With this configuration, the catheter device 1D can efficiently discharge urine 310 because the membrane portion 90 does not prevent urine 310 from flowing into the sensor portion 60D, and urine 310 that flows through the slit 22 can be easily guided to the drainage lumen 11 and the sensor portion 60D.

In the catheter device 1 according to this embodiment, the sensor unit 60 includes at least one of an oxygen sensor 61 having an oxygen sensor body 61a capable of detecting the partial pressure of oxygen in urine as biological information, or a temperature sensor 62 having a temperature sensor body 62a capable of measuring the temperature of urine 310 as biological information. The oxygen sensor body 61a may be configured as a fluorescent oxygen sensor arranged with its tip side exposed in the discharge lumen 11 so as to come into contact with the urine 310 that has flowed into the discharge lumen 11, or the temperature sensor body 62a may be configured so that its tip side is not exposed in the discharge lumen 11 so as not to come into contact with the urine 310 that has flowed into the discharge lumen 11. In addition, it is preferable that the sensor lumen 13 is configured to accommodate the sensor unit 60 in a liquid-tight manner from the viewpoint of preventing electric shock, malfunction, etc.

With this configuration, the catheter device 1 can measure the oxygen partial pressure of the urine 310 while it is placed in the bladder 300. In addition, the tip side of the oxygen sensor main body 61a, where the measuring section 61c is arranged in the outlet lumen 11, is exposed inside the outlet lumen 11, so that the oxygen partial pressure of the urine 310 flowing through the slit 22 near the outlet 12 can be measured with high accuracy. Furthermore, if the sensor lumen 13 is configured to be able to accommodate the sensor section 60 in a liquid-tight manner, the flow of urine 310 into the sensor lumen 13 can be prevented, preventing breakdown of the sensor section 60 and electric shock, etc.

The medical system 200 according to this embodiment includes at least any one of the catheter devices 1 described above, an analysis unit 242 that analyzes the biological information detected by the sensor unit 60, and a processing control unit 243 that transmits the results of the analysis by the analysis unit 242 to a communication destination, and is equipped with a measuring device 210 that is placed outside the living body.

With this configuration, various types of bioinformation acquired by the catheter device 1 placed inside a living body such as the bladder 300 can be analyzed, and the analysis results can be transmitted to a predetermined communication destination such as the operation display unit 260 or a mobile terminal. Therefore, medical staff such as doctors and nurses can keep track of the patient's vital signs based on the highly accurate bioinformation acquired by the catheter device 1.

The placement method of the catheter device 1 according to this embodiment is a method of placing a catheter device 1 having a placement section 20 to be placed in a living body, the placement section 20 having a plurality of arm sections 21 made of a tubular body that expands and contracts with deformation and can expand and contract with the inflow and outflow of fluid, and includes a step of deforming and expanding the arm sections 21 of the placement section 20 delivered to the placement position, and a step of injecting fluid into the expanded arm sections 21 to expand them and place the placement section 20 at the placement position.

With this configuration, after the retention section 20 is delivered to the living body, it can be expanded by injecting fluid into the arm section 21 while it is in a deformed and expanded state, so that when the catheter device 1 is used as a bladder retention catheter, unintentional removal of the retention section 20 retained in the bladder 300 can be prevented.

1, 1A to 1D Catheter device,
10, 10A to 10D Catheter body (10a: tip portion, 10b: base portion, 10c: lumen, 10d: opening portion),
11 outlet lumen,
12 outlet,
13 Sensor lumen,
14 first branch portion,
15 second branch portion,
16 Fluid lumen;
17 engagement groove,
20, 20A to 20D retention section,
21 Arm portion,
22 slit,
23 expansion/contraction lumen,
24 expansion guide portion,
30, 30A to 30D Tip,
31 bottom portion (31a outer periphery portion),
33 interior space,
35 communication hole,
40, 40A to 40D expansion and contraction section,
50, 50A Hub,
51 tip opening,
60, 60A to 60D sensor unit,
61 oxygen sensor (61a oxygen sensor body, 61b oxygen transmission part, 61c measurement part, 61d substrate, 61e phosphor),
62 temperature sensor (62a temperature sensor body, 62b temperature transmission part),
63 flow velocity sensor (63a flow velocity sensor body, 63b flow velocity transmission part),
70 Expansion tube,
80 Fixtures,
90 Membrane part,
100 placement device,
200, 200A Medical Systems,
210, 210A measuring device,
220 light source unit,
230 photoelectric conversion unit,
240 control unit,
241 memory unit,
242 analysis unit,
243 Processing control unit,
250 input unit,
260 Operation display unit,
300 bladder,
310 Urine,
C central axis.

Claims (22)

A catheter device having an indwelling portion to be placed in a living body,
The retention section has a plurality of expandable and contractable arm sections,
A catheter device, wherein the arm portion is composed of a tubular body that can expand and contract as fluid flows in and out. The catheter device according to claim 1, wherein the arm portion has an expansion guide portion for promoting radially outward deformation and expansion. The catheter device according to claim 2, wherein the expansion guide portion has at least one of a recess formed on the outer peripheral surface of the arm portion or a narrow portion that is narrower than the base end of the arm portion. The catheter device according to any one of claims 1 to 3, wherein the living body is a bladder. The catheter device comprises:
The catheter includes a long catheter body, an outlet lumen for guiding urine from the bladder to the outside of the living body, and an outlet port communicating with the outlet lumen,
The catheter device according to claim 4 , wherein the arm portion extends from near the outlet toward the distal end. The retention portion has a plurality of slits formed between the arm portions adjacent to each other in the circumferential direction,
The catheter device according to claim 5 , further comprising a sensor section for acquiring biological information, the sensor section being disposed near the outlet so as to radially overlap a base end of the slit when viewed in the axial direction. The catheter device according to claim 6, wherein the catheter body is arranged parallel to the outlet lumen and has a sensor lumen that houses the sensor unit. The catheter device according to claim 5, wherein the catheter device has an expansion/contraction section that expands and contracts by deforming the arm section through axial movement of the arm section. The catheter device according to claim 8, wherein the expansion/contraction section is a mandrel that can be inserted into the catheter body up to its tip, and the tip is connected to the arm section so as to be movable in the axial direction. The catheter device according to claim 8, wherein the expansion/contraction section is a hollow pipe having the outlet and an inner cavity that communicates with the outlet and functions as the outlet lumen, and can be inserted into the catheter body up to its tip, with the tip connected to the arm section so as to be movable in the axial direction. The catheter device has a distal tip that is disposed at a distal end of the indwelling portion,
The catheter device according to claim 8 , wherein the distal tip has a communicating hole whose distal end communicates with the bladder and whose proximal end communicates with the outlet lumen. the distal tip has an outer periphery to which the distal end of the arm portion is connected and a bottom portion to which the expansion/contraction portion is connected;
The catheter device according to claim 11 , wherein the bottom portion is deformed such that the outer periphery thereof tilts outward in the axial direction in association with the axial movement of the expansion/contraction portion. The catheter device according to claim 6, wherein the arm portion is eccentrically positioned on the side facing the sensor portion in the radial direction with respect to the central axis. The catheter device according to claim 6, wherein the slit is formed by twisting in the axial direction when the arm portion is contracted. the retention portion has a membrane portion formed on a proximal end side of the slit so as to connect the arm portions adjacent to each other in the circumferential direction,
The catheter device according to claim 6 , wherein the membrane portion is formed in at least one of the slits, the base end of which does not radially overlap the sensor portion when viewed in the axial direction. The catheter device according to claim 6, wherein the sensor unit includes at least one of an oxygen sensor having an oxygen sensor body capable of detecting the partial pressure of oxygen in the urine as the biological information, and a temperature sensor having a temperature sensor body capable of measuring the temperature of the urine as the biological information. The catheter device according to claim 16, wherein the oxygen sensor body is positioned with a portion exposed so as to come into contact with the urine that has flowed into the outlet lumen. The catheter device according to claim 16, wherein the temperature sensor body is positioned such that the tip side is not exposed in the outlet lumen so as not to come into contact with the urine that has flowed into the outlet lumen. The catheter device according to claim 7, wherein the sensor lumen accommodates the sensor portion in a liquid-tight manner. The catheter device according to claim 16, wherein the oxygen sensor is a fluorescent oxygen sensor. The catheter device of claim 6 ;
A medical system comprising: a measuring device placed outside the living body, the measuring device including at least an analysis unit that analyzes the biological information detected by the sensor unit; and a processing control unit that transmits the results of the analysis by the analysis unit to a communication destination. A method for placing a catheter device having an indwelling portion to be placed in a living body, comprising the steps of:
The retention section has a plurality of arms each formed of a tubular body that can expand and contract with deformation and can expand and contract with the inflow and discharge of fluid,
deforming and expanding the arm portion of the indwelling portion delivered to the indwelling position;
a step of injecting the fluid into the expanded arm portion to expand the arm portion and place the indwelling portion at the placement position;
A method for placing a catheter device, comprising: