Oxygen Measuring Device

Abstract

SOLUTION: An oxygen measurement device 10Lf comprises a urethral catheter 18jf and an oxygen sensor 400a having an oxygen sensor body 422a. At a shaft 22jf, a urine guide port 28a from which urine in the bladder 140 is made to flow in, a urinary passage 416, and a side lumen 406 are provided. At the tip of the side lumen, an opening 426 communicating with the urinary passage is provided. The oxygen sensor is disposed in the side lumen so that the oxygen sensor body becomes into contact with urine flowing in from the opening of the side lumen or the urine guide port. The urinary passage has a urine guide lumen 402. Between the side lumen and the urine guide lumen is provided a partition wall 408. At the tip of the partition wall is provided a through hole 410. At a sensor lumen 412 which forms the side lumen's part closer to the proximal end side than the through hole, a fixation part 432a for fixing the oxygen sensor to the shaft is provided.SELECTED DRAWING: Figure 36

Description

[Technical Field]

[0001] The present invention is an oximetry device that detects oxygen in urine excreted by the kidney. Su Regarding. [Background technology]

[0002] For example, Patent Document 1 discloses an oxygen measuring device in which an oxygen sensor is inserted into the bladder through the urinary tract of a urethral catheter and left in place. This oxygen measuring device detects oxygen in the epithelial wall by leading the oxygen sensor body of the oxygen sensor out of a urinary catheter opening formed at the tip of the urethral catheter and bringing it into contact with the epithelial wall of the bladder. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 2739880 Summary of the Invention [Problem to be solved by the invention]

[0004] However, research is being conducted to predict the state of the kidney by measuring the oxygen in urine, assuming that the oxygen status in urine reflects the tissue oxygen status of the kidney. The oxygen measuring device described in Patent Document 1 detects oxygen in the epithelial wall of the bladder, and therefore does not necessarily detect oxygen in the urine.

[0005] If the oxygen sensor is used to detect oxygen in urine, the oxygen sensor body may be displaced and come into contact with the bladder wall because it is exposed from the urinary catheter port inside the bladder. When the oxygen sensor body comes into contact with the bladder wall, it is detected as noise, making it difficult to measure oxygen in urine accurately.

[0006] Furthermore, if the oxygen sensor body is located in a location in the bladder where urine remains without being excreted, there is a risk that the oxygen in the urine excreted from the kidneys cannot be reliably measured.

[0007] The present invention has been made in consideration of the above-mentioned problems, and provides an oxygen measurement device that can accurately and reliably measure oxygen in fresh urine that is excreted from the kidneys through the bladder to the outside of the body. Su The purpose is to provide. [Means for solving the problem]

[0008] One aspect of the present invention comprises a urinary catheter including a flexible hollow shaft, and an oxygen sensor having an oxygen sensor main body capable of detecting oxygen in urine, wherein the shaft is provided with a urinary drainage port through which the urine in the bladder flows, a urinary tract communicating with the urinary drainage port and through which the urine flows, and a side lumen extending along the axial direction of the shaft, and an opening at the tip of the side lumen communicating with the urinary tract, and the oxygen sensor is configured such that the oxygen sensor main body detects oxygen in urine that has flowed in from the opening of the side lumen or the urinary drainage port. the urinary tract has a urinary catheter lumen arranged parallel to the lateral lumen, a partition wall extending along the urinary catheter lumen is provided between the lateral lumen and the urinary catheter lumen, a through-hole is provided at the tip of the partition wall to allow the urinary catheter lumen and the lateral lumen to pass through each other, and a sensor lumen forming a part of the lateral lumen that is proximal to the through-hole is provided with a fixing part for fixing the oxygen sensor to the shaft.

[0009] Another aspect of the present invention is an oxygen measurement system comprising the above-mentioned oxygen measurement device and a monitoring system, wherein the monitoring system comprises a urine volume calculation unit that calculates the urine volume based on the output signal of the flow rate sensor, and a urine volume determination unit that determines the stage of acute kidney injury based on the urine volume. [Effects of the Invention]

[0010] According to the present invention, the oxygen sensor body can be brought into contact with urine flowing through the urinary tract, thereby enabling accurate and reliable measurement of the oxygen in fresh urine excreted from the kidneys through the bladder and out of the body. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is a schematic diagram showing a schematic configuration of an oxygen measurement system including an oxygen measurement device according to a first embodiment of the present invention. [Figure 2] FIG. 2 is a longitudinal sectional view of the oxygen measuring device shown in FIG. 1, with a portion thereof omitted. [Figure 3] FIG. 3 is a partially omitted longitudinal sectional view taken along line III-III in FIG. 2. [Figure 4] FIG. 3 is a perspective view of the blocking portion and the oxygen sensor main body shown in FIG. 2. [Figure 5] FIG. 4 is a cross-sectional view taken along line VV in FIG. 3. [Figure 6] FIG. 2 is a block diagram illustrating the monitor main body shown in FIG. [Figure 7] FIG. 1 is a schematic diagram illustrating a method of using the oxygen measurement system. [Figure 8] 1 is a first flowchart illustrating a method of using the oximetry system. [Figure 9] 10 is a second flowchart illustrating a method of using the oximetry system. [Figure 10] FIG. 1 is a first diagram showing the measurement results of the oxygen measurement system displayed on the monitor. [Figure 11] FIG. 11A is a second diagram showing the measurement results of the oxygen measurement system displayed on the monitor, and FIG. 11B is a third diagram showing the measurement results of the oxygen measurement system displayed on the monitor. [Figure 12] FIG. 10 is a perspective view showing another configuration of the blocking portion and the oxygen sensor main body. [Figure 13] 13A is a longitudinal sectional view of an oxygen measuring device according to a first modified example, with a portion thereof omitted, and FIG. 13B is a transverse sectional view taken along line XIIIB-XIIIB in FIG. 13A. [Figure 14] FIG. 14A is a longitudinal sectional view, with a portion omitted, of an oxygen measuring device according to a second modified example, and FIG. 14B is a longitudinal sectional view, with a portion omitted, of an oxygen measuring device according to a third modified example. [Figure 15] 15A is a perspective view of the blocking portion and the oxygen sensor main body that constitute the oxygen measuring device shown in FIG. 14B, and FIG. 15B is a perspective view of the blocking portion from another angle. [Figure 16] 16A is a longitudinal sectional view of an oxygen measuring device according to a fourth modified example, with a portion thereof omitted, and FIG. 16B is a transverse sectional view taken along line XVIB-XVIB in FIG. 16A. [Figure 17] 17A is a longitudinal sectional view of an oxygen measuring device according to a fifth modified example, with a portion thereof omitted, and FIG. 17B is a transverse sectional view taken along line XVIIB-XVIIB in FIG. 17A. [Figure 18] 18A is a longitudinal sectional view of an oxygen measuring device according to a sixth modified example, with a portion thereof omitted, and FIG. 18B is a transverse sectional view taken along line XVIIIB-XVIIIB in FIG. 18A. [Figure 19] 19A is a longitudinal sectional view of an oxygen measuring device according to a seventh modified example, with a portion thereof omitted, and FIG. 19B is a transverse sectional view taken along line XIXB-XIXB in FIG. 19A. [Figure 20] 20A is a longitudinal sectional view of an oxygen measuring device according to an eighth modified example, with a portion thereof omitted, and FIG. 20B is an enlarged view of the vicinity of the oxygen sensor main body in FIG. 20A. [Figure 21] FIG. 21A is an enlarged view showing an example of the configuration of the oxygen sensor main body shown in FIG. 20B, and FIG. 21B is an enlarged view showing another example of the configuration of the oxygen sensor main body. [Figure 22] 22A is a longitudinal sectional view of an oxygen measuring device according to a ninth modified example, with a portion thereof omitted, and FIG. 22B is a longitudinal sectional view taken along line XXIIB-XXIIB in FIG. 22A. [Figure 23] FIG. 22B is a longitudinal sectional view showing an example of the configuration of the oxygen measuring device of FIG. 22A. [Figure 24] FIG. 24A is a longitudinal sectional view of an oxygen measuring device according to a tenth modified example, with a portion thereof omitted, and FIG. 24B is a longitudinal sectional view showing an example of the configuration of the oxygen measuring device. [Figure 25] FIG. 24B is a longitudinal sectional view showing another example of the configuration of the oxygen measuring device shown in FIG. 24A. [Figure 26] FIG. 10 is a schematic diagram showing the general configuration of an oxygen measurement system including an oxygen measurement device according to a second embodiment of the present invention. [Figure 27] FIG. 27 is a longitudinal sectional view of the oxygen measuring device shown in FIG. 26, with a portion thereof omitted. [Figure 28] FIG. 28 is a longitudinal cross-sectional view taken along line XXVIII-XXVIII in FIG. 27. [Figure 29] 29A is a cross-sectional view taken along line XXIXA-XXIXA in FIG. 28, and FIG. 29B is a cross-sectional view taken along line XXIXB-XXIXB in FIG. [Figure 30] FIG. 28 is a cross-sectional view illustrating a first configuration example of the oxygen measuring device of FIG. 27. [Figure 31] FIG. 28 is a cross-sectional view illustrating a second configuration example of the oxygen measuring device of FIG. 27. [Figure 32] FIG. 28 is a cross-sectional view illustrating a third configuration example of the oxygen measuring device of FIG. 27. [Figure 33] FIG. 33 is a longitudinal cross-sectional view taken along line XXXIII-XXXIII in FIG. 32. [Figure 34] FIG. 28 is a cross-sectional view illustrating a fourth configuration example of the oxygen measuring device of FIG. [Figure 35] FIG. 28 is a cross-sectional view illustrating a fifth configuration example of the oxygen measuring device of FIG. 27. [Figure 36] 36A is a cross-sectional view illustrating a sixth configuration example of the oxygen measuring device in FIG. 27, and FIG. 36B is a cross-sectional view illustrating a seventh configuration example of the oxygen measuring device in FIG. [Figure 37] 37A is a cross-sectional view illustrating an eighth configuration example of the oxygen measuring device in FIG. 27, and FIG. 37B is a cross-sectional view illustrating a ninth configuration example of the oxygen measuring device in FIG. [Figure 38] 38A is a cross-sectional view illustrating a tenth configuration example of the oxygen measuring device in FIG. 27, and FIG. 38B is a cross-sectional view illustrating an eleventh configuration example of the oxygen measuring device in FIG. [Figure 39]39A is a cross-sectional view illustrating a twelfth configuration example of the oxygen measuring device in FIG. 27, and FIG. 39B is a cross-sectional view illustrating a thirteenth configuration example of the oxygen measuring device in FIG. [Figure 40] 40A is a cross-sectional view illustrating a fourteenth configuration example of the oxygen measuring device in FIG. 27, and FIG. 40B is a cross-sectional view illustrating a fifteenth configuration example of the oxygen measuring device in FIG. [Figure 41] 41A is a cross-sectional view illustrating a sixteenth configuration example of the oxygen measuring device in FIG. 27, and FIG. 41B is a cross-sectional view illustrating a seventeenth configuration example of the oxygen measuring device in FIG. [Figure 42] 42A is a cross-sectional view illustrating an 18th configuration example of the oxygen measuring device in FIG. 27, and FIG. 42B is a cross-sectional view illustrating a 19th configuration example of the oxygen measuring device in FIG. [Figure 43] 43A is a cross-sectional view illustrating a twentieth configuration example of the oxygen measuring device in FIG. 27, and FIG. 43B is a cross-sectional view illustrating a 21st configuration example of the oxygen measuring device in FIG. [Figure 44] FIG. 2 is a cross-sectional view showing an example of the configuration of a shaft. [Figure 45] FIG. 45A is a cross-sectional view illustrating a first configuration example of the shaft, FIG. 45B is a cross-sectional view illustrating a second configuration example of the shaft, and FIG. 45C is a cross-sectional view illustrating a third configuration example of the shaft. DETAILED DESCRIPTION OF THE INVENTION

[0012] Hereinafter, preferred embodiments of an oxygen measuring device according to the present invention will be described in relation to an oxygen measuring system with reference to the accompanying drawings.

[0013] (First embodiment) The oxygen measurement system 12 according to the first embodiment of the present invention is for measuring the oxygen partial pressure (oxygen concentration) in urine excreted from the kidneys into the bladder 140 in order to predict the state of the kidneys.

[0014] As shown in Fig. 1, the oxygen measurement system 12 includes an oxygen measurement device 10A having a urinary catheter 18a, a urine collection bag 14 (urine collection container), and a monitoring system 16. In the following description, the right side of the urinary catheter 18a in Fig. 2 will be referred to as the "base end side," and the left side of the urinary catheter 18a will be referred to as the "tip side," and the same applies to the other figures.

[0015] 1 and 2, the oxygen measuring device 10A includes a urinary catheter 18a and an oxygen sensor 20a. The urinary catheter 18a is a medical device that is placed inside the living body during use and drains urine from a bladder 140 (see FIG. 7) into a urine collection bag 14 placed outside the body. The urinary catheter 18a includes a flexible hollow shaft 22a, a blocking section 23a (tip cap) provided at the tip of the shaft 22a, a balloon 24 provided at the tip of the shaft 22a, and a hub 26 provided at the base end of the shaft 22a.

[0016] The shaft 22a is a thin, long tube. The shaft 22a has appropriate flexibility and rigidity to allow the tip of the urethral catheter 18a to be smoothly inserted through the urethra 144 (see FIG. 7) into the bladder 140. Examples of materials that can be used to form the shaft 22a include rubber such as silicone or latex, other elastomers, vinyl chloride, polyurethane, and plastic tubes.

[0017] As shown in Figures 2 and 3, the shaft 22a is formed with two urinary drainage ports 28a that allow urine in the bladder 140 to flow into the shaft 22a, an inner cavity 30 that communicates with the urinary drainage ports 28a and extends over the entire length of the shaft 22a, and an expansion lumen 32 that allows the expansion fluid for the balloon 24 to flow through.

[0018] Each urine drainage port 28a opens at a location on the outer circumferential surface of the shaft 22a closer to the tip than the balloon 24. The two urine drainage ports 28a are provided at positions facing each other. The urine drainage ports 28a are elongated holes extending in the longitudinal direction of the shaft 22a. Specifically, the urine drainage ports 28a are formed in a rectangular shape with each short side protruding outward in an arc shape (a shape close to an ellipse) (see FIG. 2). The shape, size, position and number of the urine drainage ports 28a can be set as desired.

[0019] A distal opening 34 of the lumen 30 is formed on the distal end surface of the shaft 22a. The distal opening 34 of the lumen 30 is blocked by a blocking portion 23a. The blocking portion 23a is made of the same material as the shaft 22a. As shown in Figures 2 to 4, the blocking portion 23a has a distal bulging portion 36 that bulges distally from the shaft 22a, and a protruding portion 38 that protrudes proximally from the proximal end surface 36a of the distal bulging portion 36 and fits liquid-tightly into the distal opening 34 of the lumen 30. The outer surface of the distal bulging portion 36 is configured as a partially curved surface of a spheroid. The proximal end surface 36a of the distal bulging portion 36 is formed flat. The protruding portion 38 is formed in a rectangular parallelepiped shape.

[0020] 2 and 3, the occlusion portion 23a is fixed to the shaft 22a by adhesive 40. The adhesive 40 is injected between the base end surface 36a of the distal swelling portion 36 and the distal end surface 58a of the shaft 22a, and between the protrusion 38 and the wall surface that forms the distal opening 34 of the lumen 30. The adhesive 40 seals the distal end of the expansion lumen 32. A locking groove 41 is formed across the entire width on each of two side surfaces 38b located on both sides in the height direction (short direction) of the protrusion end surface 38a of the protrusion 38 (see FIG. 4).

[0021] The portion of the inner cavity 30 of the shaft 22a closer to the proximal end than the occluding portion 23a functions as a urinary catheterization lumen 42. The urinary catheterization lumen 42 is provided so that the axis Ax of the shaft 22a is located within the urinary catheterization lumen 42. The urinary catheterization lumen 42 has a rectangular cross section (see FIG. 5). However, the cross section of the urinary catheterization lumen 42 may have any shape.

[0022] As shown in FIG. 3, a temperature sensor 44 is embedded in the wall of the shaft 22a. The temperature sensor 44 includes a temperature sensor main body 46 (temperature probe) for detecting the temperature inside the bladder 140 (see FIG. 7) and a temperature transmitter 48 electrically connected to the temperature sensor main body 46. The temperature sensor main body 46 is located at the same position as the urinary drainage opening 28a in the axial direction of the shaft 22a. The temperature sensor main body 46 includes a thermocouple, a resistance temperature detector, or a thermistor. The temperature sensor 44 can detect the temperature of urine inside the bladder 140 (see FIG. 7). The temperature sensor main body 46 may be disposed inside the urinary drainage lumen 42. In this case, the temperature of urine flowing through the urinary tract 74 can be detected with high accuracy.

[0023] An oxygen sensor 20a is provided in the urinary catheter lumen 42. The oxygen sensor 20a is configured as a so-called fluorescent (optical) oxygen sensor and includes an oxygen sensor main body 50a capable of detecting oxygen in urine, and a transmission section 52 (optical fiber 58) formed separately from the oxygen sensor main body 50a and disposed in the urinary catheter lumen 42. The oxygen sensor 20a is fixed to the urinary catheter 18a so that the oxygen sensor main body 50a comes into contact with urine flowing through the urinary catheter lumen.

[0024] The oxygen sensor main body 50a has a substrate 54a (base) and a phosphor 56 applied to substantially the entire surface of one side of the substrate 54a. The substrate 54a is made of a material that is transmissive to the excitation light from the optical fiber 58 and the fluorescence from the phosphor 56. Such a substrate 54a is made of, for example, glass or polyethylene. The substrate 54a has the same width as the protruding portion 38 and is provided on the protruding portion 38 so that at least a portion of the phosphor 56 is located within the urinary drainage lumen 42. Specifically, the substrate 54a is bent into a substantially U-shape and covers the protruding end surface 38a and two side surfaces 38b of the protruding portion 38. Each end of the substrate 54a in the extending direction is bent and fitted into each of the locking grooves 41.

[0025] The phosphor 56 is made of a material that emits fluorescence when irradiated with excitation light from the optical fiber 58. Specific examples of materials that make up the phosphor 56 include platinum porphyrin, ruthenium complexes, and pyrene derivatives. The phosphor 56 is coated to block ambient light. However, the phosphor 56 does not necessarily need to be coated.

[0026] The transmitting section 52 is an optical fiber 58 capable of irradiating the phosphor 56 with excitation light and receiving fluorescence from the phosphor 56, and is fixed to the urinary catheter 18a with a tip surface 58a of the optical fiber 58 positioned relative to the phosphor 56. A glass optical fiber or a plastic optical fiber is used as the optical fiber 58. The optical fiber 58 is fixed to the shaft 22a by a fixing section 60 so that the tip surface 58a, where the core is exposed, faces the phosphor 56 at a distance.

[0027] The fixing part 60 includes a fiber support part 64 provided in the wall surface constituting the urinary drainage lumen 42 and having an insertion hole 62 into which the tip end of the optical fiber 58 is inserted, and an adhesive 66 for fixing the optical fiber 58 to the wall surface constituting the urinary drainage lumen 42. The adhesive 66 seals a through hole 68 formed in the outer surface of the shaft 22a. The adhesive 66 is made of a material that is transparent to light from the optical fiber 58 and fluorescence from the phosphor 56. Therefore, even if the adhesive 66 gets between the tip end surface 58a of the optical fiber 58 and the substrate 54a, the excitation light from the optical fiber 58 can be irradiated onto the phosphor 56, and the fluorescence from the phosphor 56 can be received by the optical fiber 58. In the axial direction of the shaft 22a, the position of the tip end surface 58a of the optical fiber 58 is substantially the same as the position of the tip end of the urinary drainage port 28a.

[0028] The balloon 24 can expand and contract due to changes in internal pressure. That is, the balloon 24 expands when an expansion fluid is introduced into the balloon 24, and contracts when the expansion fluid is discharged from the balloon 24. Note that FIG. 1 shows the balloon 24 in an expanded state.

[0029] The hub 26 is molded integrally into a hollow shape from the same material as the shaft 22a or from a resin material. The hub 26 is provided with a urination port 70 communicating with the urination lumen 42 and a balloon expansion port 72 communicating with the expansion lumen 32. The urination lumen 42 and the urination port 70 form a urinary passage 74, which serves as a urine discharge flow path for the urinary catheter 18a. A flow rate sensor 76 capable of detecting the flow rate of urine flowing through the urination port 70 is provided on the wall surface of the urination port 70. That is, the flow rate sensor 76 is provided so as to come into contact with the urine flowing through the urination port 70 or is provided near the wall surface. The balloon expansion port 72 is configured to be connectable to a pressure application device (not shown) for pressure-feeding expansion fluid into the balloon 24 via the expansion lumen 32. The balloon expansion port 72 also includes a valve structure (not shown) that opens when the pressure application device is connected and closes when the pressure application device is disconnected. The hub 26 is configured so that a cable connector 90 of the monitoring system 16 can be attached and detached.

[0030] As shown in Figure 1, the urine collection bag 14 is configured as a so-called closed-type urine collection bag, and includes a bag body 78, a urine drainage tube 80 for guiding urine in the urinary catheter 18a into the bag body 78, and a urination section 82 for discharging urine from the bag body 78. Such a urine collection bag 14 is configured as an integral unit using a resin material or the like. However, the urine collection bag 14 may also be a separate bag.

[0031] 1 and 2, the monitoring system 16 includes a cable connector 90 that is detachable from the hub 26, a long transmission cable 92 connected to the cable connector 90, and a monitor main body 94 that is connected to the transmission cable 92. The cable connector 90 is provided with an oxygen cable 96 that is optically connected to the transmission unit 52, a temperature cable 98 that is electrically connected to the temperature transmission unit 48, and a flow rate cable 100 that is electrically connected to the flow velocity sensor 76. The oxygen cable 96 is an optical fiber, and the temperature cable 98 and the flow rate cable 100 are electrical wires. The oxygen cable 96, the temperature cable 98, and the flow rate cable 100 are bundled together by the transmission cable 92 and extend to the monitor main body 94.

[0032] The transmission cable 92 is arranged along the urine drainage tube 80 and is fastened to the urine drainage tube 80 by a plurality of fastening members 102 (cable ties). This prevents the urine drainage tube 80 and the transmission cable 92 from getting in the way when the oxygen measuring device 10A is in use.

[0033] As shown in FIG. 6, the monitor main body 94 includes a light emitting unit 104, a light receiving unit 106, an A / D converter 108, a start button 110, a stop button 112, a monitor 114, and a control unit 116.

[0034] The light-emitting unit 104 is, for example, a light-emitting diode, and emits excitation light of a predetermined wavelength to the oxygen cable 96. The light-receiving unit 106 is, for example, a photodiode, and receives the fluorescent light transmitted from the oxygen cable 96. The A / D converter 108 converts the light-receiving signal of the light-receiving unit 106 into a digital value and outputs it to the control unit 116.

[0035] The start button 110 is a button for starting measurement of the oxygen partial pressure in urine. The stop button 112 is a button for stopping measurement of the oxygen partial pressure in urine. The monitor main body 94 is also provided with a power button and the like (not shown).

[0036] The monitor 114 is configured to be able to display the oxygen partial pressure in urine calculated by the control unit 116. The monitor 114 is a so-called full-dot liquid crystal display, and is capable of displaying predetermined information in color. The monitor 114 has a touch panel function, and also functions as an input unit for inputting predetermined information. As an input format for the monitor 114, in addition to the touch panel type, pointing devices such as a mouse cursor type, a touch pen type, and a touch pad type can also be used. Note that information input to the monitor main body 94 is not limited to input via the monitor 114, and may also be input using input buttons, etc.

[0037] The control unit 116 includes a storage unit 118 and various function realization units. The function realization units are software function units whose functions are realized by a CPU (Central Processing Unit) executing programs stored in the storage unit 118, but they can also be realized by hardware function units formed from integrated circuits such as FPGAs (Field-Programmable Gate Arrays). The storage unit 118 includes a writable nonvolatile memory (for example, a flash memory) and can store information input via the monitor 114, information calculated by the control unit 116, and the like.

[0038] The control unit 116 has a memory unit 118, an oxygen partial pressure calculation unit 120, a urine volume calculation unit 122, a flow rate calculation unit 123, a flow rate determination unit 124, a urine volume condition setting unit 126, a urine volume determination unit 128, and a display control unit 130. The control unit 116 also has a temperature input unit (not shown) to which an output signal from the temperature sensor 44 is input, and a flow rate input unit (not shown) to which an output signal from the flow rate sensor 76 is input.

[0039] The oxygen partial pressure calculation unit 120 calculates the oxygen partial pressure in the urine based on the output signal of the oxygen sensor 20a and the output signal of the temperature sensor 44. The urine volume calculation unit 122 calculates the urine volume based on the output signal of the flow velocity sensor 76. The flow velocity calculation unit 123 calculates the flow velocity of urine in the urinary tract 74 based on the output signal from the flow velocity sensor 76.

[0040] The urine volume condition setting unit 126 sets predetermined urine volume conditions. Specifically, the urine volume condition setting unit 126 sets a first urine volume determination value and a second urine volume determination value. The first urine volume determination value is calculated, for example, by multiplying a first urine volume reference value (0.5 ml / kg / h) used to determine the first and second stages of acute kidney injury (AKI) by the patient's weight. The second urine volume determination value is calculated by multiplying a second urine volume reference value (0.3 ml / kg / h) used to determine the third stage of acute kidney injury by the patient's weight. However, the urine volume condition setting unit 126 can set any conditions. The urine volume determination unit 128 determines whether the urine volume calculated by the urine volume calculation unit 122 matches the predetermined urine volume conditions.

[0041] The display control unit 130 changes the display format of the oxygen partial pressure displayed on the monitor 114 according to the urine flow rate acquired based on the output signal of the flow rate sensor 76. Specifically, when the flow rate determination unit 124 determines that the urine flow rate is equal to or greater than a predetermined value (equal to or greater than the reference flow rate V0), the display control unit 130 causes the monitor 114 to display the oxygen partial pressure in a first display format, and when the flow rate determination unit 124 determines that the urine flow rate is less than the predetermined value (less than the reference flow rate V0), the display control unit 130 causes the monitor 114 to display the oxygen partial pressure in a second display format different from the first display format. The display control unit 130 causes the monitor 114 to display a graph showing the time change in the oxygen partial pressure. When the urine volume determination unit 128 determines that the urine volume meets the urine volume condition, the display control unit 130 causes the monitor 114 to display that fact.

[0042] Next, the assembly of the oxygen sensor 20a to the urinary catheter 18a will be described. As shown in FIGS. 2 to 5, in this embodiment, the optical fiber 58 is disposed in the urinary catheter lumen 42, and its tip is inserted into the insertion hole 62 of the fiber support part 64. Then, adhesive 66 is injected from the outside of the shaft 22a through the through-hole 68, thereby fixing the optical fiber 58 to the shaft 22a. The substrate 54a of the oxygen sensor main body 50a is bent into a U-shape, and both ends of the substrate 54a are locked into the locking grooves 41 of the protrusion 38. Then, with the adhesive 66 applied to the tip surface 58a of the shaft 22a and the wall surfaces constituting the tip opening 34, the closure part 23a holding the oxygen sensor main body 50a is fitted into the tip opening 34 of the shaft 22a. This fixes the closure part 23a to the shaft 22a, and the oxygen sensor main body 50a to the shaft 22a. This allows the fluorescent material 56 and the tip surface 58a of the optical fiber 58 to be positioned with high precision.

[0043] Next, the use of the oxygen measuring device 10A will be described.

[0044] As shown in Figures 7 and 8, a preparation step is first performed (step S1 in Figure 8). In the preparation step, the tip of the urethral catheter 18a is placed in the bladder 140. Specifically, the tip of the shaft 22a, to which lubricating jelly has been applied, is inserted from the patient's urethral opening 142 into the urethra 144, and the urinary catheter opening 28a and the balloon 24 are placed in the bladder 140. Note that a stylet (not shown) may be inserted into the urinary catheter lumen 42 of the shaft 22a to provide sufficient rigidity to the shaft 22a, making it easier to insert the urethral catheter 18a into the bladder 140.

[0045] Thereafter, inflation fluid is pressure-fed from the balloon inflation port 72 to the inflation lumen 32 (see FIG. 2) by a pressure application device (not shown), thereby inflating the balloon 24. This prevents the urethral catheter 18a from slipping out of the body, and the distal end of the shaft 22a beyond the balloon 24 is retained within the bladder 140. In FIG. 7, reference numeral 146 denotes the pubic bone, reference numeral 148 denotes the prostate, and reference numeral 150 denotes the external urethral sphincter muscle.

[0046] When the tip of the urinary catheter 18a is placed in the bladder 140, urine in the bladder 140 can be drained through the urinary catheter 18a into the urine collection bag 14. At this time, in the urinary catheter 18a, urine in the bladder 140 flows into the urinary tract 74 from the urinary drainage port 28a.

[0047] The user also inputs the patient's weight into the monitor main body 94 (step S2). Then, the urine volume condition setting unit 126 calculates the first urine volume determination value and the second urine volume determination value based on the input patient's weight (step S3).

[0048] Thereafter, the user operates the start button 110 (step S4). This starts measurement of the oxygen partial pressure in urine. Once the start button 110 is operated, measurement of the oxygen partial pressure in urine is performed continuously or intermittently (for example, every 5 minutes) until the stop button 112 is operated.

[0049] Specifically, the control unit 116 acquires various data (step S5). Specifically, the control unit 116 acquires the output signal of the temperature sensor 44 and the output signal of the flow velocity sensor 76. The control unit 116 also controls the light emitter 104 to emit excitation light of a predetermined wavelength. The excitation light emitted from the light emitter 104 is then transmitted to the optical fiber 58 via the oxygen cable 96 and irradiated onto the phosphor 56 in the oxygen sensor main body 50a from the distal end 58a of the optical fiber 58. The phosphor 56 irradiated with the excitation light transitions from the ground state to an excited state and returns to the ground state while emitting fluorescence. If oxygen molecules are present around the phosphor 56, the excitation energy is absorbed by the oxygen molecules through an interaction, resulting in a decrease in the intensity of the fluorescent emission. This phenomenon is called quenching, and the intensity of the fluorescent emission is inversely proportional to the oxygen molecule concentration. The fluorescence from the phosphor 56 enters the distal end 58a of the optical fiber 58 and is guided to the light receiver 106 via the optical fiber 58 and the oxygen cable 96. The light receiving signal from the light receiving unit 106 is converted into a digital signal by the A / D converter 108 and input to the control unit 116. In this way, the output signal of the oxygen sensor 20a is obtained.

[0050] Thereafter, the oxygen partial pressure calculation unit 120 calculates the oxygen partial pressure in the urine based on the output signal of the oxygen sensor 20a (the output signal of the A / D converter 108) and the output signal of the temperature sensor 44 (step S6). Furthermore, the flow rate determination unit 124 determines whether the urine flow rate V obtained based on the output signal of the flow rate sensor 76 is equal to or greater than a predetermined value (reference flow rate V0) (step S7). The reference flow rate V0 is stored in advance in the storage unit 118.

[0051] If the flow velocity determination unit 124 determines that the flow velocity V is equal to or greater than the reference flow velocity V0 (step S7: YES), the display control unit 130 sets the calculated oxygen partial pressure to be displayed on the monitor 114 in the first display format (step S8). On the other hand, if the flow velocity determination unit 124 determines that the flow velocity V is less than the reference flow velocity V0 (step S7: NO), the display control unit 130 sets the calculated oxygen partial pressure to be displayed on the monitor 114 in the second display format (step S9).

[0052] Next, urine volume determination control (step S10) is performed. As shown in FIG. 9, in this urine volume determination control (step S10), first, the urine volume calculation unit 122 calculates the urine volume and its integrated value (step S20). That is, the urine volume calculation unit 122 calculates the urine volume based on the output signal of the flow velocity sensor 76. The calculated urine volume is stored in the memory unit 118. Then, the urine volume calculation unit 122 calculates the integrated value of the urine volume by adding the urine volume calculated in the current measurement to the urine volume stored in the memory unit 118. The integrated value of the urine volume is stored in the memory unit 118.

[0053] Thereafter, the urine volume calculation unit 122 calculates the urine volume per unit time (for example, per hour) based on the integrated value of the urine volume (step S21). Subsequently, the urine volume determination unit 128 determines whether the urine volume per unit time meets the urine volume condition (step S22).

[0054] Specifically, the urine volume determination unit 128 determines whether the condition corresponds to any of the first to third stages of AKI. That is, the urine volume determination unit 128 determines that the condition corresponds to the first stage when the state in which the urine volume per unit time is less than the first urine volume determination value continues for six hours or more. Furthermore, the urine volume determination unit 128 determines that the condition corresponds to the second stage when the state in which the urine volume per unit time is less than the first urine volume determination value continues for twelve hours or more. Furthermore, the urine volume determination unit 128 determines that the condition corresponds to the third stage when the state in which the urine volume per unit time is less than the second urine volume determination value continues for 24 hours or more or when there is no urine volume continues for twelve hours or more.

[0055] If the urine volume determination unit 128 determines that the condition matches any one of the first to third stages of AKI (step S22: YES), the display control unit 130 sets the monitor 114 to display a message indicating that the condition matches (that the condition is in the first to third stages) (step S23), and proceeds to the processing of step S11 in Fig. 8. On the other hand, if the urine volume determination unit 128 determines that the condition does not match any one of the first to third stages of AKI (step S22: NO), the display control unit 130 proceeds to the processing of step S11 in Fig. 8.

[0056] 10, the display control unit 130 causes the monitor 114 to display various information. Specifically, as shown in Fig. 10, the display control unit 130 causes the monitor 114 to display, for example, the oxygen partial pressure, the bladder temperature, the urine volume, and the integrated value of the urine volume as numerical values, and also causes the monitor 114 to display the time change in the oxygen partial pressure and the time change in the bladder temperature as graphs. Furthermore, if the urine volume determination control determines that the patient falls into any of the first to third stages of AKI (step S22: YES), the display control unit 130 causes the monitor 114 to display that fact. Note that if the urine volume determination control determines that the patient does not fall into any of the first to third stages of AKI (step S22: NO), the display control unit 130 does not cause the monitor 114 to display AKI.

[0057] In the example of FIG. 10, the oxygen partial pressure is displayed as 38 mmHg, the intrabladder temperature is displayed as 37.4°C, the urine volume per unit time is displayed as 25.1 mL / h, the cumulative urine volume is displayed as 532 mL, and the AKI is displayed as stage 1. The time change in oxygen partial pressure is displayed as a bar graph, and the time change in intrabladder temperature is displayed as a line graph. That is, the horizontal axis is time, one vertical axis is oxygen partial pressure (mmHg), and the other vertical axis is temperature (°C). In the bar graph, the filled-in portion represents the oxygen partial pressure displayed in the first display format, and the unfilled portion represents the oxygen partial pressure displayed in the second display format. That is, in the bar graph, the oxygen partial pressure in the filled-in portion represents the oxygen partial pressure in urine when the urine flow rate V is equal to or greater than the reference flow rate V0, and the oxygen partial pressure in the unfilled portion represents the oxygen partial pressure in urine when the urine flow rate V is less than the reference flow rate V0.

[0058] The first and second display formats of the oxygen partial pressure are not limited to the example of Fig. 10. For example, in a bar graph, the first display format may be displayed in a non-filled state, and the second display format may be displayed in a filled state.

[0059] 11A, the display control unit 130 may display the time change in oxygen partial pressure as a line graph on the monitor 114. In this case, in the line graph, the thick line portion represents the part of the oxygen partial pressure displayed in the first display format, and the thin line portion represents the part of the oxygen partial pressure displayed in the second display format. However, the first display format may be displayed as a thin line, and the second display format may be displayed as a thick line.

[0060] 11B, the portion of the line graph where the area below the line segment representing the oxygen partial pressure is filled in may be the first display format of the oxygen partial pressure, and the portion where the area below is not filled in may be the second display format of the oxygen partial pressure. However, the first display format may be displayed with the area below not filled in, and the second display format may be displayed with the area below filled in.

[0061] Thereafter, the control unit 116 determines whether the stop button 112 has been operated (step S12). If the stop button 112 has not been operated (step S12: NO), the processing of step S5 and subsequent steps is performed. On the other hand, if the stop button 112 has been operated (step S12: YES), the control unit 116 stops the oxygen measurement operation (step S13). That is, it stops the emission of excitation light by the light-emitting unit 104. At this stage, the oxygen measurement processing of this flowchart ends.

[0062] Next, the effects of this embodiment will be described.

[0063] The oxygen measuring device 10A comprises a urinary catheter 18a including a flexible hollow shaft 22a, and an oxygen sensor 20a having an oxygen sensor main body 50a capable of detecting oxygen in urine. The shaft 22a is provided with a urinary drainage port 28a through which urine from a bladder 140 flows, and a urinary tract 74 that communicates with the urinary drainage port 28a and through which the urine flows. The oxygen sensor 20a is provided in the urinary catheter 18a so that the oxygen sensor main body 50a comes into contact with urine flowing through the urinary tract 74.

[0064] This allows the oxygen sensor main body 50a to come into contact with the urine flowing through the urinary tract 74, making it possible to accurately and reliably measure the oxygen in fresh urine that is excreted from the kidneys through the bladder 140 and out of the body.

[0065] The oxygen sensor 20a has an oxygen sensor main body 50a having a phosphor 56 and a substrate 54a on which the phosphor 56 is applied, and an optical fiber 58 formed separately from the oxygen sensor main body 50a. The oxygen sensor main body 50a is fixed to the urinary catheter 18a so that at least a portion of the phosphor 56 comes into contact with urine in the urinary tract 74, and the optical fiber 58 is fixed to the urinary catheter 18a with a tip surface 58a of the optical fiber 58 positioned relative to the phosphor 56 so that excitation light can be irradiated onto the phosphor 56 and fluorescence from the phosphor 56 can be received. In this way, the oxygen sensor main body 50a having the phosphor 56 and the optical fiber 58 can be manufactured separately and incorporated into the urinary catheter 18a to measure oxygen in urine.

[0066] A tip opening 34 of the lumen 30 that constitutes the urinary tract 74 is formed at the tip of the shaft 22a. The urinary catheter 18a has an occluding part 23a that is fitted into the tip opening 34, and the oxygen sensor main body 50a is fixed to the occluding part 23a. In this case, by fitting the occluding part 23a to which the oxygen sensor main body 50a is fixed into the tip opening 34 from the tip side of the shaft 22a, the oxygen sensor main body 50a can be accurately, easily, and reliably assembled into the shaft 22a.

[0067] The optical fiber 58 is fixed to the shaft 22a so that the distal end surface 58a of the optical fiber 58 is located within the urinary tract 74 and faces the phosphor 56. This allows the excitation light from the optical fiber 58 to be efficiently irradiated onto the phosphor 56, and also allows the optical fiber 58 to efficiently receive the fluorescence from the phosphor 56.

[0068] In this embodiment, the phosphor 56 covers substantially the entire protruding end surface 38a of the protrusion 38, which makes it easy to position the optical fiber 58 relative to the phosphor 56. Furthermore, when fixing the optical fiber 58, the adhesive 66 can be injected through a through-hole 68 formed in the outer surface of the shaft 22a, which improves assembly and prevents the tip surface 58a of the optical fiber 58 from being contaminated with the adhesive 66.

[0069] 12, the substrate 54a of the oxygen sensor main body 50a has a width dimension narrower than the width dimension of the protruding portion 38, and the protruding portion 38 of the blocking portion 23b may have an engagement groove 200 formed therein into which the substrate 54a, bent into a generally U-shape, fits. The substrate 54a is formed in a strip shape. The engagement groove 200 is located at the center of the width of the protruding portion 38, extends along each side surface 38b in the protruding direction of the protruding portion 38, and extends along the entire height of the protruding end surface 38a. This configuration allows for less material to be used for the substrate 54a and the phosphor 56, thereby reducing the manufacturing cost of the oxygen sensor main body 50a.

[0070] Next, oxygen measuring devices 10B to 10K according to first to tenth modifications will be described.

[0071] (First Modification) Next, an oxygen measuring device 10B according to a first modified example will be described. In the oxygen measuring device 10B according to the first modified example, the same components as those in the oxygen measuring device 10A described above are denoted by the same reference numerals, and detailed descriptions thereof will be omitted.

[0072] 13A and 13B, an oxygen measuring device 10B according to a first modification includes a urinary catheter 18b. A sensor lumen 202, in which an optical fiber 58 is disposed, is formed in the wall of a shaft 22b of the urinary catheter 18b. That is, a partition wall 204 is provided between the urinary drainage lumen 42 and the sensor lumen 202. A gap S, through which urine can flow, is provided between the tip surface of the partition wall 204 and the phosphor 56. The optical fiber 58 is fixed to the shaft 22b with an adhesive 66 filled in the sensor lumen 202 so as to seal a through-hole 68 formed in the outer surface of the tip of the shaft 22b. The through-hole 68 is formed in a portion of the outer circumferential surface of the shaft 22b that is located between the two urinary drainage ports 28a.

[0073] According to this modification, optical fiber 58 is disposed in sensor lumen 202, and therefore, it is possible to prevent optical fiber 58 from interfering with the flow of urine in urinary tract 74. This allows urine to flow smoothly in urinary tract 74.

[0074] In this modification, the same configuration as the oxygen measuring device 10A described above provides the same effects.

[0075] (Second Modification) Next, an oxygen measuring device 10C according to a second modification will be described. In the oxygen measuring device 10C according to the second modification, the same components as those of the oxygen measuring device 10B according to the first modification will be given the same reference numerals, and detailed descriptions thereof will be omitted. The same applies to the fourth, fifth, ninth, and tenth modifications described later.

[0076] 14A, an oxygen measuring device 10C according to a second modification includes a urinary catheter 18c and an oxygen sensor 20b. The urinary catheter 18c includes a shaft 22c and an occluding portion 23c. An arrangement hole 206 in which an optical fiber 58 is disposed is formed in a protruding portion 38 of the occluding portion 23c. A partition wall 204 extends to the position of a protruding end surface 38a of the protruding portion 38.

[0077] The substrate 54b of the oxygen sensor main body 50b covers the arrangement hole 206 from the base end side and is fixed to the protruding end surface 38a of the protruding portion 38 so that the phosphor 56 comes into contact with urine in the urinary tract 74. The substrate 54b is configured to be transmissive to the excitation light from the optical fiber 58 and the fluorescence from the phosphor 56. The phosphor 56 is located closer to the tip side than the urine drainage port 28a.

[0078] The optical fiber 58 is fixed to the urinary catheter 18c in a state where it is bent back 180 degrees from the distal end of the urinary tract 74 toward the proximal end so that the distal end surface 58a of the optical fiber 58 is located on the opposite side of the oxygen sensor main body 50b from the urinary tract 74. That is, the bent back portion of the optical fiber 58 is disposed in the arrangement hole 206 of the protrusion 38. The optical fiber 58 is fixed to the shaft 22c and the blocking portion 23c by injecting an adhesive 66 into the arrangement hole 206 from the outside of the shaft 22c via a through-hole 68 formed in the outer surface of the shaft 22c. The distal end surface 58a of the optical fiber 58 is in contact with the back surface of the substrate 54b opposite the surface on which the phosphor 56 is applied. However, the distal end surface 58a of the optical fiber 58 may be close to the back surface of the substrate 54b.

[0079] Next, the assembly of the oxygen sensor 20b to the urinary catheter 18c will be described. Note that, in the initial state, the substrate 54b, on which the phosphor 56 is applied, is fixed to the protruding end surface 38a of the protruding portion 38 with an adhesive or the like (not shown). In this modification, the optical fiber 58 is inserted into the sensor lumen 202, and the tip of the optical fiber 58 is pulled out distally from the distal opening 34 of the shaft 22c. The tip of the optical fiber 58 is then bent back 180 degrees and placed in the placement hole 206 of the protruding portion 38. At this time, the distal end surface 58a of the optical fiber 58 is in contact with or close to the back surface of the substrate 54b. Next, adhesive 40 is applied to the distal end surface 58a of the shaft 22c and the wall surface that defines the distal opening 34, and the protruding portion 38 is fitted into the distal opening 34. At this time, the portion of the optical fiber 58 that was pulled out distally is pushed back proximally by the blocking portion 23c. Thereafter, the optical fiber 58 is fixed to the shaft 22c and the blocking portion 23c by injecting adhesive 66 into the arrangement hole 206 from the outside of the shaft 22c through the through-hole 68. This allows the fluorescent material 56 and the tip surface 58a of the optical fiber 58 to be positioned with high precision.

[0080] According to this modification, optical fiber 58 is fixed to urinary catheter 18c in a state where it is folded back further distal than urinary tract 74 so that distal end surface 58a of optical fiber 58 is located on the opposite side of oxygen sensor main body 50b from urinary tract 74. The base portion is configured to be transmissive to excitation light from optical fiber 58 and fluorescence from phosphor 56. This improves assembly ease and accuracy, and makes it possible to measure oxygen in urine while preventing distal end surface 58a of optical fiber 58 from coming into contact with urine and becoming contaminated.

[0081] Furthermore, the tip surface 58a of the optical fiber 58 is in contact with the surface of the substrate 54b (base) opposite to the surface on which the phosphor 56 is applied. This allows the phosphor 56 to be brought into contact with urine more reliably, and also allows the excitation light from the optical fiber 58 to be efficiently irradiated onto the phosphor 56, while the fluorescence from the phosphor 56 can be efficiently received by the optical fiber 58.

[0082] Furthermore, the blocking portion 23c is formed with an arrangement hole 206 in which the folded-back portion of the optical fiber 58 is disposed. This allows the optical fiber 58 to be easily arranged in a folded-back state on the distal end side of the urinary tract 74.

[0083] In this modification, the same configuration as the oxygen measuring devices 10A and 10B described above provides the same effects.

[0084] (Third Modification) Next, an oxygen measuring device 10D according to a third modified example will be described. In the oxygen measuring device 10D according to the third modified example, the same components as those of the oxygen measuring device 10C according to the second modified example will be denoted by the same reference numerals, and detailed descriptions thereof will be omitted.

[0085] As shown in FIGS. 14B to 15B, an oxygen measuring device 10D according to a third modification includes a urinary catheter 18d and an oxygen sensor 20c. The urinary catheter 18d includes a shaft 22d and an occluding portion 23d. The occluding portion 23d includes a distal bulge 208 and a protruding portion 210. The distal bulge 208 includes a first hole 212 through which the optical fiber 58 can be disposed, and a slit 214 that communicates with the first hole 212 and opens to the outer surface of the distal bulge 208. The first hole 212 includes a first opening 212a and a second opening 212b that open to a base end surface 208a of the distal bulge 208, and a third opening 212c that opens to the tip of the distal bulge 208. The first opening 212a communicates with the sensor lumen 202. The second opening 212b is located approximately at the center of the base end surface. The slit 214 extends along the axial direction from the first opening 212a to the third opening 212c.

[0086] A rectangular recess 215 in which the oxygen sensor main body 50c can be disposed is provided on the protruding end surface 210a of the protruding portion 210. A second hole 216 communicating with the second opening 212b is formed on the side surface 210b of the protruding portion 210. The second hole 216 extends linearly from the second opening 212b to the bottom surface of the recess 215. The first hole 212 and the second hole 216 communicate with each other and function as an arrangement hole 217 in which the optical fiber 58 is disposed.

[0087] The oxygen sensor main body 50c has a support part 218 fixed to the blocking part 23d. A substrate 54b is fixed to the support part 218. The support part 218 is formed in the shape of a rectangular plate, and is fixed to the protruding part 210 while being disposed in the recess 215. The support part 218 is provided with a positioning hole 220 (positioning part) for positioning the tip of the optical fiber 58. The phosphor 56 is located closer to the tip side than the urine drainage port 28b.

[0088] The optical fiber 58 is held in the blocking portion 23d while being arranged in the arrangement hole 217. That is, the optical fiber 58 is held in the blocking portion 23d while being arranged in the first opening 212a, the first hole 212, the second opening 212b, and the second hole 216. The optical fiber 58 is bent back 180 degrees toward the proximal end within the first hole 212, which is distal to the urinary tract 74. In this modification, the slit 214 and the third opening 212c are formed in the blocking portion 23d, so that the blocking portion 23d can be easily bent when the optical fiber 58 is bent back within the first hole 212. The distal end surface 58a of the optical fiber 58 is in contact with the rear surface of the substrate 54b. However, the distal end surface 58a of the optical fiber 58 may be proximal to the substrate 54b.

[0089] The urine drainage port 28b is formed so that the opening width along the circumferential direction increases toward the tip of the shaft 22d.

[0090] Next, the assembly of oxygen sensor 20c to urinary catheter 18d will be described. Note that in the initial state, substrate 54b coated with phosphor 56 is fixed to support portion 218, and support portion 218 is fixed in recess 215 of protrusion 210 with an adhesive or the like (not shown). In this modification, optical fiber 58 is inserted into sensor lumen 202, and the tip of optical fiber 58 is pulled out toward the tip from tip opening 34 of shaft 22d.

[0091] The blocking portion 23d is then held so that the third opening 212c faces the tip of the optical fiber 58, and the tip of the optical fiber 58 is inserted from the third opening 212c into the blocking portion 23d and reaches the second hole portion 216 through the second opening 212b, and the tip of the optical fiber 58 is fitted into the positioning hole 220 so that the tip surface 58a contacts the back surface of the substrate 54b or is positioned in the vicinity thereof, and an adhesive (not shown) is applied between the wall surface constituting the second hole portion 216 and the optical fiber 58 to fix them. Thereafter, the blocking portion 23d is held, and the blocking portion 23d is turned over 180° while checking that the optical fiber 58 is being positioned in the positioning hole 217 while pushing and widening the slit 214, and the optical fiber 58 is positioned in the first opening 212a through the first hole portion 212, and the base end surface 208a of the blocking portion 23d is opposed to the tip surface 58a of the shaft 22d.

[0092] Thereafter, adhesive 40 is applied to the distal end surface 58a of the shaft 22d and the wall surfaces constituting the distal end opening 34, and the protruding portion 210 is fitted into the distal end opening 34. This fixes the blocking portion 23d to the shaft 22d, thereby fixing the oxygen sensor main body 50c fixed to the blocking portion 23d to the shaft 22d. At this time, the portion of the optical fiber 58 that was pulled out distally is pushed back distally by the shaft 22d and retracted into the arrangement hole 217. Then, adhesive 66 is injected into the sensor lumen 202 from the outside of the shaft 22d through the through-hole 68, thereby fixing the optical fiber 58 to the shaft 22d. Furthermore, adhesive (not shown) is injected from the third opening 212c into the arrangement hole 217 so as to fill the third opening 212c and the slit 214, thereby fixing the optical fiber 58 to the blocking portion 23d. This improves assembly and enables accurate positioning of the phosphor 56 and the distal end surface 58a of the optical fiber 58.

[0093] In another assembly method, the optical fiber 58 is folded back 180 degrees, and the tip of the optical fiber 58 is passed through the third opening 212c, the first hole 212, the second opening 212b, and the second hole 216, and fitted into the positioning hole 220 of the support part 218. Next, the outer part of the tip bulge 208 of the optical fiber 58 is pushed toward the slit 214 with the part aligned with the slit 214. This widens the width of the slit 214, and the optical fiber 58 is positioned within the first hole 212 and the first opening 212a.

[0094] Thereafter, adhesive 40 is applied to the distal end surface 58a of the shaft 22d and the wall surfaces constituting the distal end opening 34, and the protruding portion 210 is fitted into the distal end opening 34. This fixes the blocking portion 23d to the shaft 22d, thereby fixing the oxygen sensor main body 50c fixed to the blocking portion 23d to the shaft 22d. At this time, the portion of the optical fiber 58 that was pulled out distally is pushed back proximally by the blocking portion 23d. Then, adhesive 66 is injected into the sensor lumen 202 from the outside of the shaft 22d through the through-hole 68, thereby fixing the optical fiber 58 to the shaft 22d. Furthermore, adhesive (not shown) is injected from the third opening 212c into the arrangement hole 217 so as to fill the third opening 212c and the slit 214, thereby fixing the optical fiber 58 to the blocking portion 23d. This allows for accurate positioning of the phosphor 56 and the distal end surface 58a of the optical fiber 58.

[0095] According to this modification, the optical fiber 58 is held by the closure portion 23d while being disposed in the arrangement hole 217. This allows the optical fiber 58 to be accurately assembled to the shaft 22d when the closure portion 23d is fitted into the tip opening 34 of the shaft 22d.

[0096] In this modified example, the oxygen sensor main body 50c has a support part 218 fixed to the closing part 23d. A substrate 54b is fixed to the support part 218. The support part 218 is provided with a positioning hole 220 for positioning the tip of the optical fiber 58. This makes it possible to precisely maintain the positional relationship between the tip surface 58a of the optical fiber 58 and the phosphor 56. In addition, the oxygen sensor main body 50c can be fixed to the closing part 23d by grasping the support part 218.

[0097] Furthermore, phosphor 56 is located closer to the tip than urinary drainage opening 28b, which is formed so that the opening width along the circumferential direction increases toward the tip of shaft 22d, thereby enabling urine introduced into urinary tract 74 from urinary drainage opening 28b to be efficiently introduced to phosphor 56 located closer to the tip than urinary drainage opening 28b.

[0098] In this modification, the same effects can be achieved with the same configuration as the oxygen measuring devices 10A to 10C described above. The urine drainage port 28b of this modification may be provided in the oxygen measuring devices 10A to 10C described above.

[0099] (Fourth Modification) Next, an oxygen measuring device 10E according to a fourth modification will be described. As shown in Figures 16A and 16B, the oxygen measuring device 10E according to the fourth modification includes a urinary catheter 18e and an oxygen sensor 20d. The urinary catheter 18e includes a shaft 22e and an obstructing portion 23e.

[0100] The oxygen sensor main body 50d of the oxygen sensor 20d is fixed to the shaft 22e so that the phosphor 56 is located closer to the base end than the urine drainage port 28a in the urine drainage lumen 42 (urinary tract 74). The substrate 54c (base) of the oxygen sensor main body 50d is configured to be transmissive to light from the optical fiber 58 and fluorescence from the phosphor 56. The substrate 54c is configured in an annular shape and extends in a direction perpendicular to the axis of the shaft 22e so that the phosphor 56 is located closer to the tip end than the substrate 54c. In other words, the substrate 54c has an inner hole 228 through which urine flows. However, the substrate 54c may be formed in a ring shape, for example, a square ring shape, as long as it is ring-shaped.

[0101] A retaining hole 230 into which the outer edge of the substrate 54c is inserted is formed in the wall surface constituting the urinary catheterization lumen 42. The retaining hole 230 includes a first slit 230a that opens to the outer surface of the shaft 22e and is sized to allow the oxygen sensor body 50d to be inserted into the urinary tract 74 from outside the shaft 22e, and a second slit 230b that is formed in a wall portion 232 between the expansion lumen 32 and the urinary catheterization lumen 42. The first slit 230a extends approximately 180° in the circumferential direction of the shaft 22e. The second slit 230b extends to the expansion lumen 32. That is, a portion of the outer edge of the substrate 54c is located within the expansion lumen 32. The substrate 54c is located distal to the balloon 24. The distal end surface 58a of the partition wall 204 contacts the rear surface of the substrate 54c, opposite the surface on which the phosphor 56 is located.

[0102] The substrate 54c is fixed to the shaft 22e by an adhesive 66 injected into the first slit 230a and the second slit 230b. The adhesive 66 seals a part of the expansion lumen 32, the first slit 230a, and the second slit 230b, and also flows into the sensor lumen 202 to fix the optical fiber 58 to the shaft 22e.

[0103] The optical fiber 58 is provided closer to the base end than the base portion so that the tip surface 58a of the optical fiber 58 faces the back surface of the substrate 54c. The tip surface 58a of the optical fiber 58 is in contact with the back surface of the substrate 54c. However, the tip surface 58a of the optical fiber 58 may be close to the back surface of the substrate 54c.

[0104] Next, the assembly of the oxygen sensor 20d to the urinary catheter 18e will be described. In this modification, the optical fiber 58 is inserted into the sensor lumen 202. Then, with adhesive 66 applied to the outer edge of the substrate 54c, the oxygen sensor main body 50d is pushed into the first slit 230a from the outside of the shaft 22e. This causes the oxygen sensor main body 50d to be inserted into the second slit 230b and held in the holding hole 230. Then, adhesive 66 is injected from the outside of the shaft 22e into the first slit 230a, which serves as a through-hole, to fix the oxygen sensor main body 50d and the optical fiber 58 to the shaft 22e. This allows the phosphor 56 and the distal end surface 58a of the optical fiber 58 to be positioned with precision.

[0105] According to this modification, the phosphor 56 is located closer to the base end than the urinary drainage opening 28a in the urinary tract 74. This allows the phosphor 56 to efficiently come into contact with urine flowing through the urinary drainage lumen 42.

[0106] In this modification, the substrate 54c is configured to allow the excitation light from the optical fiber 58 and the fluorescence from the phosphor 56 to pass through, and extends in a direction perpendicular to the axis of the shaft 22e so that the phosphor 56 is located closer to the distal end than the substrate 54c. The optical fiber 58 is provided closer to the proximal end than the base so that the distal end surface 58a of the optical fiber 58 faces the rear surface opposite the surface of the base on which the phosphor 56 is applied. This allows urine in the urinary tract 74 to efficiently come into contact with the phosphor 56. Furthermore, the excitation light from the optical fiber 58 can be efficiently irradiated onto the phosphor 56, and the fluorescence from the phosphor 56 can be efficiently received by the optical fiber 58.

[0107] Furthermore, the base plate 54c is configured in an annular shape, which allows urine in the urinary drainage lumen to flow smoothly in the direction of the proximal end of the shaft 22e through the inner hole of the base plate 54c.

[0108] According to this modification, a holding hole 230 into which the outer edge of the base is inserted is formed in the wall surface that constitutes the urinary drainage lumen 42. This makes it possible, with a simple configuration, to hold the base plate 54c in a state in which it extends in a direction perpendicular to the axis of the shaft 22e.

[0109] The retaining hole 230 also includes a first slit 230a that opens to the outer surface of the shaft 22e and is large enough to allow the oxygen sensor body 50d to be inserted into the urinary tract 74 from the outside of the shaft 22e, and the oxygen sensor body 50d is fixed to the shaft 22e with adhesive 66 that is filled to seal the first slit 230a. In this case, the oxygen sensor body 50d can be easily and accurately assembled from the outside of the shaft 22e.

[0110] In this modification, the same configuration as the oxygen measuring devices 10A to 10D provides the same effects.

[0111] (Fifth Modification) Next, an oxygen measuring device 10F according to a fifth modified example will be described. As shown in Figures 17A and 17B, the oxygen measuring device 10F according to the fifth modified example includes a urinary catheter 18f and an oxygen sensor 20e. The urinary catheter 18f includes a shaft 22f and an obstructing portion 23e.

[0112] The oxygen sensor main body 50e of the oxygen sensor 20e is fixed to the shaft 22f so that the phosphor 56 is located closer to the base end of the urinary catheter lumen 42 (urinary tract 74) than the urinary catheter opening 28a. The substrate 54d (base) of the oxygen sensor main body 50e is made of glass, polyethylene, or the like, so that excitation light from the optical fiber 58 and fluorescence from the phosphor 56 can transmit therethrough. The substrate 54d is flat. The oxygen sensor main body 50e has a support part 240a fixed to the shaft 22f. The support part 240a is fixed to the substrate 54d. The support part 240a is made of the same material as the shaft 22f or a glass, resin, or the like, and has a rectangular ring shape corresponding to the cross-sectional shape of the urinary catheter lumen 42. In other words, the outer surface of the support part 240a is in contact with the wall surface that constitutes the urinary catheter lumen 42. The support part 240a is provided closer to the base end of the urinary catheter lumen 42 than the urinary catheter opening 28a. The substrate 54d is fixed to the wall surface defining the inner hole 241a of the support portion 240a in a state in which it extends in the axial direction of the shaft 22f. That is, the phosphor 56 is located in the inner hole 241a of the support portion 240a.

[0113] The support part 240a has two protrusions 246, 248 (second engagement parts) that are positioned on the shaft 22f by fitting into two support holes 242, 244 (first engagement parts) that serve as through-holes provided in the wall surface that constitutes the urinary drainage lumen 42. The two support holes 242, 244 are located on opposite sides of the support part 240a. The support hole 242 is a through-hole that extends to the outer surface of the shaft 22f so as to cross the sensor lumen 202. The support hole 244 is a through-hole that extends to the outer surface of the shaft 22f so as to cross the expansion lumen 32.

[0114] The protrusions 246, 248 are hemispherical protrusions that protrude outward from the outer surface of the support body 245. The support body 245 and the protrusion 246 are provided with a positioning hole 250 (positioning portion) into which the tip of the optical fiber 58 fits. The positioning hole 250 opens to the surface of the wall that constitutes the inner hole 241a of the support body 240a, where the substrate 54d is fixed.

[0115] The optical fiber 58 is disposed in the sensor lumen 202, the support hole 242, and the positioning hole 250. The tip surface 58a of the optical fiber 58 is in contact with the back surface of the substrate 54d. However, the tip surface 58a of the optical fiber 58 may be close to the back surface of the substrate 54d. The support portion 240a and the optical fiber 58 are fixed to the shaft 22f by an adhesive 252 that is filled to seal the support holes 242, 244.

[0116] Next, the assembly of the oxygen sensor 20e to the urinary catheter 18f will be described. Note that, in the initial state, the substrate 54d coated with the phosphor 56 is fixed to the support portion 240a with an adhesive or the like (not shown). In this modification, the optical fiber 58 is inserted into the sensor lumen 202, and the tip of the optical fiber 58 is pulled out distally from the tip opening 34 of the shaft 22f. In this state, the optical fiber 58 is inserted into the support hole 242. Then, with the tip of the optical fiber 58 fitted into the positioning hole 250 of the support portion 240a, the support portion 240a is inserted through the tip opening 34 of the shaft 22f, and the protrusion 246 is fitted into the support hole 242, and the protrusion 248 is fitted into the support hole 244. At this time, the portion of the optical fiber 58 that was pulled out distally is pushed back proximally by the support portion 240a. Then, adhesive 252 is injected into each of the support holes 242, 244 from the outside of the shaft 22f to fix the support portion 240a and the optical fiber 58 to the shaft 22f. This allows the phosphor 56 and the tip surface 58a of the optical fiber 58 to be positioned with high precision. Thereafter, the protrusion 38 of the blocking portion 23e is fitted into the tip opening 34 of the shaft 22f.

[0117] As another assembly method, the optical fiber 58 may be left pulled out from the support hole 242 through the sensor lumen 202, the support portion 240a may be inserted through the tip opening 34 of the shaft 22f, the convex portion 246 may be fitted into the support hole 242, and the convex portion 248 may be fitted into the support hole 244, and then the tip of the optical fiber 58 may be fitted into the positioning hole 250 of the support portion 240a, and the portion of the optical fiber 58 that was pulled out from the support hole 242 may be pushed back toward the base end.

[0118] According to this modification, the oxygen sensor main body 50e has a support part 240a fixed to the shaft 22f. The support part 240a is provided with a positioning hole 250 to which the substrate 54d is fixed and which positions the tip of the optical fiber 58. This makes it possible to precisely maintain the positional relationship between the tip surface 58a of the optical fiber 58 and the phosphor 56. In addition, the oxygen sensor main body 50e can be incorporated into the urinary tract 74 by grasping the support part 240a.

[0119] In this modification, support holes 242, 244 are provided in the wall surfaces that form the urinary tract 74, and the support portion 240a is provided with protrusions 246, 248 that are positioned on the shaft 22f by fitting (engaging) with the support holes 242, 244. This allows the oxygen sensor main body 50e to be incorporated into the urinary tract 74 with high precision.

[0120] Furthermore, the support part 240a is configured in an annular shape, and the phosphor 56 is located in the inner hole 241a of the support part 240a. Therefore, urine in the urinary tract 74 can be brought into contact with the phosphor 56 while flowing through the inner hole 241a of the support part 240a.

[0121] Furthermore, the substrate 54d extends along the axial direction of the shaft 22f, which makes it possible to prevent the flow of urine through the inner hole 241a of the support part 240a from being obstructed by the substrate 54d, compared to when the substrate 54d extends along a direction perpendicular to the axis of the shaft 22f.

[0122] In this modification, the same configuration as the oxygen measuring devices 10A to 10E described above provides the same effects.

[0123] In this modified example, the first engagement portion may be a convex portion formed on the wall surface that constitutes the urinary drainage lumen 42, and the second engagement portion may be a hole portion formed in the support portion 240a into which the convex portion fits.

[0124] (Sixth Modification) Next, an oxygen measuring device 10G according to a sixth modified example will be described. In the oxygen measuring device 10G according to the sixth modified example, the same components as those of the oxygen measuring device 10F according to the fifth modified example will be given the same reference numerals, and detailed descriptions thereof will be omitted. The same applies to the seventh and eighth modified examples described later.

[0125] As shown in FIGS. 18A and 18B, an oxygen measuring device 10G according to the sixth modification includes an oxygen sensor 20f. The substrate 54e (base) of the oxygen sensor main body 50f constituting the oxygen sensor 20f is configured in a rectangular ring shape, extends in a direction perpendicular to the axial direction of the shaft 22f, and is disposed in an inner hole 241b of a support portion 240b so that the phosphor 56 is located on the distal end side. A support protrusion 260 that protrudes inward and supports the rear surface of the substrate 54e is provided on the wall surface constituting the inner hole 241b of the support portion 240b. A positioning hole 250 into which the distal end of an optical fiber 58 is fitted is formed on the rear surface of the substrate 54e in the support portion 240b. A distal end surface 58a of the optical fiber 58 contacts the rear surface of the substrate 54e. However, the distal end surface 58a of the optical fiber 58 may be adjacent to the rear surface of the substrate 54e.

[0126] When such an oxygen sensor 20f is used, the phosphor 56 extends in a direction perpendicular to the axis of the shaft 22f, so that urine introduced into the urine drainage lumen 42 from the urine drainage port 28a can be brought into contact with the phosphor 56 efficiently.

[0127] In this modification, the same configuration as the oxygen measuring devices 10A to 10F described above provides the same effects.

[0128] (Seventh Modification) Next, an oxygen measuring device 10H according to a seventh modification will be described. As shown in FIGS. 19A and 19B, the oxygen measuring device 10H according to the seventh modification includes an oxygen sensor 20g. The support portion 240c of the oxygen sensor main body 50g constituting the oxygen sensor 20g is made of a material that is transmissive to the excitation light from the optical fiber 58 and the fluorescence from the phosphor 56. Examples of such materials include the same material as that of the substrate 54d. The substrate 54d is fixed to the wall surface constituting the inner hole 241c of the support portion 240c while extending in the axial direction of the shaft 22f. The support portion 240c is provided with a protrusion 246a that protrudes into the sensor lumen 202, and this protrusion 246a is formed with a positioning hole 250 into which the tip of the optical fiber 58 fits. The tip surface 58a of the optical fiber 58 faces the tip when the tip of the optical fiber 58 is fitted in the positioning hole 250. That is, the optical fiber 58 is fitted into the positioning hole 250 in a state in which it extends linearly from the sensor lumen 202. That is, the phosphor 56 is positioned in a direction intersecting (perpendicular to) the direction in which the tip surface 58a of the optical fiber 58 is oriented.

[0129] The convex portion 246a is formed with a reflecting portion 270 that guides the excitation light from the optical fiber 58 to the phosphor 56 and guides the fluorescence from the phosphor 56 into the optical fiber 58. The reflecting portion 270 can be configured, for example, as a mirror formed by coating a metal film on a flat surface obtained by cutting out a portion of the convex portion 246a at an angle. However, the reflecting portion 270 may have any configuration as long as it can reflect the excitation light from the optical fiber 58 and the fluorescence from the phosphor 56.

[0130] When such an oxygen sensor 20g is used, for example, the excitation light from the optical fiber 58 can be irradiated onto the phosphor 56 by the reflecting portion 270 without bending the optical fiber 58, and the fluorescence from the phosphor 56 can be received by the optical fiber 58.

[0131] In this modification, the same configuration as the oxygen measuring devices 10A to 10G described above provides the same effects.

[0132] (Eighth Modification) Next, an oxygen measuring device 10I according to an eighth modification will be described. As shown in Figures 20A and 20B, the oxygen measuring device 10I according to the eighth modification includes a urinary catheter 18g and an oxygen sensor 20h. The urinary catheter 18g includes a shaft 22g and an obstructing portion 23e.

[0133] The oxygen sensor main body 50h of the oxygen sensor 20h is fixed to the shaft 22g so that the phosphor 56 is located closer to the base end than the urine drainage port 28a in the urine drainage lumen 42. The substrate 54d of the oxygen sensor main body 50h is configured in a flat plate shape and is fixed to a flat support part 240d so that it extends in the axial direction of the shaft 22g and the phosphor 56 faces inward into the urine drainage lumen 42. A positioning hole 250 (positioning part) into which the tip of the optical fiber 58 fits is formed in the support part 240d. The positioning hole 250 is located on the back surface side of the substrate 54d.

[0134] The tip of the optical fiber 58 is fitted into the positioning hole 250 with the optical fiber 58 inserted through an insertion hole 280 formed in the partition wall 204. A wall surface 280a constituting the insertion hole 280 is inclined toward the tip from the sensor lumen 202 side toward the urinary drainage lumen 42 side. The tip surface 58a of the optical fiber 58 is in contact with the back surface of the substrate 54d with the tip of the optical fiber 58 fitted into the positioning hole 250. However, the tip surface 58a of the optical fiber 58 may be close to the back surface of the substrate 54d. The support part 240d and the optical fiber 58 are fixed to the shaft 22g by an adhesive 252 that is filled so as to seal the through-hole 68 and the insertion hole 280 formed in the outer surface of the shaft 22g.

[0135] Next, we will explain how to assemble the oxygen sensor 20h to the urinary catheter 18g. Note that, in the initial state, the substrate 54d coated with the phosphor 56 is fixed to the support part 240d with an adhesive or the like (not shown). In this modification, the optical fiber 58 is inserted into the sensor lumen 202, and the tip of the optical fiber 58 is pulled out distally from the tip opening 34 of the shaft 22g. In this state, the optical fiber 58 is inserted through the insertion hole 280. Then, with the tip of the optical fiber 58 fitted into the positioning hole 250 of the support part 240d and adhesive applied to the back surface of the support part 240d, the optical fiber 58 is pulled back proximally while the support part 240d is inserted through the tip opening 34 of the shaft 22g, and the insertion hole 280 is brought into contact with the wall surface constituting the urinary catheter lumen 42 so as to cover the insertion hole 280 from the urinary catheter lumen 42 side. Then, adhesive 252 is injected from the outside of shaft 22g through through-hole 68 into sensor lumen 202 and insertion hole 280, thereby fixing support portion 240d and optical fiber 58 to shaft 22g. This allows accurate positioning of phosphor 56 and tip surface 58a of optical fiber 58. Thereafter, protrusion 38 of closure portion 23e is fitted into tip opening 34 of shaft 22g.

[0136] In this modification, the same configuration as the oxygen measuring devices 10A to 10H provides the same effects.

[0137] In this modification, the oxygen sensor 20h may include an oxygen sensor main body 50ha shown in FIG. 21A. An inclined surface 282 is formed on the substrate 54f of the oxygen sensor main body 50ha at the axial tip of the shaft 22g, and an inclined surface 284 is formed on the support portion 240e at the axial tip of the shaft 22g. Each inclined surface 282, 284 is inclined in the opposite direction from the sensor lumen 202 (inward of the shaft 22g) toward the base end of the shaft 22g. The inclined surfaces 282 and 284 are flush with each other. The phosphor 56 is applied to the inclined surface 282 and a surface continuing from the inclined surface 282 toward the base end. A recess 286 is formed on the back surface of the substrate 54f, which is continuous with the positioning hole 250 of the support portion 240e. The tip of the optical fiber 58 is fitted into the recess 286 and the positioning hole 250. Furthermore, the tip surface 58a of the optical fiber 58 is parallel to the inclined surface 282 (the phosphor 56 applied to the inclined surface 282) when the tip of the optical fiber 58 is fitted into the recess 286 and the positioning hole 250. The sensor lumen 202 extends to the tip of the shaft 22g.

[0138] When such an oxygen sensor 20h is used, the phosphor 56 applied to the inclined surface 282 extends inward of the shaft 22g toward the base end of the shaft 22g, so that urine in the urinary catheter lumen can be brought into contact with the phosphor 56 efficiently.

[0139] 21B. The support portion 240f of the oxygen sensor main body 50hb is provided with a protrusion 288 that fits into the insertion hole 280. In this case, the support portion 240f can be positioned in the insertion hole 280 easily and accurately.

[0140] In this modification, the urinary catheter 18g may omit the through-hole 68. In this case, with the support portions 240d-240f positioned on the wall surfaces that form the urinary catheterization lumen 42, adhesive 252 is injected from the tip opening of the sensor lumen 202. This fills the sensor lumen 202 and the insertion hole 280 with adhesive 252, allowing the support portions 240d-240f and the optical fiber 58 to be fixed to the shaft 22g.

[0141] (Ninth Modification) Next, an oxygen measuring device 10J according to a ninth modification will be described. As shown in Figures 22A and 22B, the oxygen measuring device 10J according to the ninth modification includes a urinary catheter 18h and an oxygen sensor 300.

[0142] The shaft 22h of the urinary catheter 18h is formed with a sensor lumen 202 that opens at a portion of the wall constituting the urinary drainage port 28c toward the proximal end of the shaft 22h. The oxygen sensor 300 is configured as a fluorescent oxygen sensor and includes an oxygen sensor main body 302 capable of detecting oxygen in urine and a transmission section 304 that is integrally provided at the tip of the oxygen sensor main body 302 and extends along the shaft 22h. In other words, the oxygen sensor main body 302 is integrally provided at the tip of the transmission section 304. The transmission section 304 is configured as an optical fiber, and the oxygen sensor main body 302 is configured to contain a fluorescent material. However, the oxygen sensor 300 may also be configured as an electrode-type oxygen sensor. In this case, the transmission section 304 is electrically connected to the oxygen sensor main body 302.

[0143] The distal end surface 302a of the oxygen sensor main body 302 is located within the urine drainage port 28c. The opening width of the urine drainage port 28c along the circumferential direction at the distal end is larger than the opening width of the base end in the circumferential direction. In other words, the urine drainage port 28c is formed so that the opening width along the circumferential direction increases toward the distal end of the shaft 22h.

[0144] According to this modification, the oxygen sensor main body 302 is integrally provided (fixed) to the tip of the transmission part 304, so that the oxygen sensor 300 can be easily assembled to the shaft 22h.

[0145] The oxygen sensor main body 302 is located inside the urine drainage port 28c, so that the oxygen sensor main body 302 can come into contact with urine flowing in from the urine drainage port 28c.

[0146] Furthermore, since the transmitting part 304 is disposed in the sensor lumen 202, the transmission part 304 can be prevented from interfering with the flow of urine in the urinary tract 74.

[0147] In this modification, oxygen sensor main body 302 is located at the base end of urine drainage opening 28c, i.e., in the part with the narrow opening width. Therefore, oxygen in urine can be measured stably at a part of urine drainage opening 28c that is less likely to deform even when subjected to external force, and damage to the sensor due to deformation can be prevented. Note that oxygen sensor main body 302 and transmission part 304 may be assembled to sensor lumen 202 in a pre-separated state, and after being positioned or fitted within sensor lumen 202, adhesive may be injected through a through-hole (not shown) to fix them in place.

[0148] As shown in FIG. 23, the oxygen measuring device 10J may include an oxygen sensor 20i instead of the oxygen sensor 300. The oxygen sensor 20i includes an oxygen sensor main body 50i, a transmission section 52 (optical fiber 58), and a support section 240d that supports the oxygen sensor main body 50i. The oxygen sensor main body 50i is formed by applying a phosphor 56 to the surface of a flat substrate 54d. The support section 240d is made of a transparent material that allows excitation light and fluorescence to pass through. The support section 240d includes a hollow support main body 290 disposed in the urinary drainage lumen 42 and a pair of hollow protrusions 291 extending in opposite directions from the support main body 290 and disposed within each urinary drainage port 28c. The inner cavity of the support main body 290 extends along the axial direction of the shaft 22h over the entire length of the support main body 290 and communicates with the inner cavities of the protrusions 291. The outer surface of the protruding portion 291 contacts the wall surface that constitutes the urine drainage port 28c so as to cover the opening on the tip side of the sensor lumen 202. The protruding length of the protruding portion 291 is set to be approximately the same as the length dimension of the urine drainage port 28c along the radial direction of the shaft 22h (the thickness dimension of the shaft 22h). Therefore, the protruding portion 291 does not protrude outward from the urine drainage port 28c.

[0149] A recess 292 is formed on the inner surface of protrusion 291 on the tip side of sensor lumen 202. Substrate 54d is fitted into recess 292 and fixed thereto with an adhesive or the like (not shown) so that phosphor 56 comes into contact with urine flowing through the cavity of protrusion 291. A positioning recess 293 into which the tip of optical fiber 58 fits is formed on the outer surface of protrusion 291 in a portion covering sensor lumen 202 (opposite recess 292).

[0150] Next, the assembly of the oxygen sensor 20i to the urinary catheter 18h will be described. Note that, in the initial state, the substrate 54d coated with the phosphor 56 is fixed to the support portion 240d with an adhesive (not shown) or the like. In this case, with the optical fiber 58 inserted into the sensor lumen 202, the tip of the optical fiber 58 is pulled out from the distal opening of the sensor lumen 202 by a length sufficient for fitting distally. Then, the support portion 240d is inserted through the distal opening 34 of the shaft 22h, and the protruding portion 291 is fitted into the urinary drainage port 28c. At this time, the tip of the optical fiber 58 is fitted into the positioning recess 293 of the support portion 240d. Thereafter, the support portion 240d, the optical fiber 58, and the sensor lumen 202 are bonded together with an adhesive (not shown). If necessary, the portion of the optical fiber 58 that was pulled out distally is pushed back toward the base end by the support portion 240d. Furthermore, the support portion 240d and the shaft 22h are bonded together with an adhesive (not shown) as necessary. This configuration provides the same effects as the above-described embodiment. Note that the tip of the optical fiber 58 may be inserted through the tip opening 34 of the shaft 22h with the tip thereof previously fitted into the positioning recess 293 of the support portion 240d.

[0151] (Tenth Modification) Next, an oxygen measuring device 10K according to a tenth modification will be described. As shown in Fig. 24A, the oxygen measuring device 10K according to the tenth modification includes a urinary catheter 18i and an oxygen sensor 300. The oxygen sensor 300 is the same as that described in the ninth modification.

[0152] The shaft 22i of the urinary catheter 18i is formed with a urinary catheter lumen 42 extending in the axial direction of the shaft 22i, a sensor lumen 202 in which a transmission section 304 of an oxygen sensor 300 is disposed, and a lateral urinary catheter lumen 310 that communicates with the urinary catheter lumen 42 and is provided at the distal end of the sensor lumen 202. The lateral urinary catheter lumen 310 is located closer to the proximal end than the urinary catheter opening 28a. The oxygen sensor 300 extends within the lateral urinary catheter lumen 310 so that the oxygen sensor main body 302 is located within the urinary catheter lumen 42. The distal end of the oxygen sensor main body 302 is located near the proximal end of the urinary catheter opening 28a. The distal end of the sensor lumen 202 is filled with an adhesive (not shown) that seals the sensor lumen 202 and fixes the transmission section 304 to the shaft 22i.

[0153] According to this modification, since the transmitting part 304 is disposed in the sensor lumen 202, it is possible to prevent the transmitting part 304 from interfering with the flow of urine in the urinary catheterization lumen 42. This allows for smooth flow of urine in the urinary catheterization lumen 42. In addition, the oxygen sensor main body 302 can be brought into efficient contact with urine in the urinary catheterization lumen 42.

[0154] In this oxygen measuring device 10K, as shown in Fig. 24B, the lateral urinary drainage lumen 310 may communicate with the tip of the urinary drainage lumen 42. That is, the lateral urinary drainage lumen 310 is located at the same position as the tip of the urinary drainage port 28a in the axial direction of the shaft 22i. In this case, the oxygen sensor main body 302 is located on the proximal side of the urinary drainage port 28a by having the transmitting section 304 bent back 180° from the lateral urinary drainage lumen 310 toward the proximal side toward the urinary drainage lumen 42. This allows the oxygen sensor main body 302 to efficiently come into contact with urine introduced into the urinary drainage lumen 42 from the urinary drainage port 28a.

[0155] 25, the protruding portion 38 of the blocking portion 23e may be formed with an arrangement hole 312 in which the folded-back portion of the transmitting portion 304 is arranged. In this case, the protruding portion 38 holds the folded-back portion of the transmitting portion 304. This makes it possible to prevent the oxygen sensor main body 302 from shifting position within the urinary catheterization lumen 42.

[0156] (Second embodiment) Next, an oxygen measurement system 12A according to a second embodiment will be described. In the oxygen measurement system 12A according to this embodiment, the same components as those in the oxygen measurement system 12 described above are given the same reference numerals, and detailed descriptions thereof will be omitted.

[0157] The oxygen measurement system 12A shown in FIG. 26 is for measuring the oxygen partial pressure (oxygen concentration) in urine excreted from the kidney into the bladder 140 in order to predict the condition of the kidney, and is equipped with an oxygen measurement device 10L, a urine collection bag 14 (urine collection container), and a monitoring system 16.

[0158] 26 and 27, the oxygen measuring device 10L includes a urinary catheter 18j and an oxygen sensor 400a. The urinary catheter 18j is a medical device that is placed inside the living body during use and drains urine from the bladder 140 into a urine collection bag 14 placed outside the body. The urinary catheter 18j includes a thin, long, hollow shaft 22j, a balloon 24 provided at the tip end of the shaft 22j, and a hub 26a provided at the base end of the shaft 22j.

[0159] The shaft 22j is a long tube with a hemispherical tip. The shaft 22j has appropriate flexibility and rigidity to allow the tip of the urethral catheter 18j to be smoothly inserted through the urethra 144 into the bladder 140. The shaft 22j may be made of the same material as the shaft 22a described above.

[0160] As shown in FIG. 27, the shaft 22j has two urinary drainage ports 28a for allowing urine in the bladder 140 to flow into the shaft 22j, a urinary drainage lumen 402 that extends along the axial direction of the shaft 22j and functions as a urination flow path, a side lumen 406 in which an oxygen sensor 400a and a temperature sensor 404 are disposed, and an expansion lumen 32 for circulating an expansion fluid for the balloon 24.

[0161] Each urine drainage port 28a opens at a location on the outer circumferential surface of the shaft 22j that is closer to the tip than the balloon 24. In the illustrated example, the two urine drainage ports 28a are provided at positions facing each other (see FIGS. 27 and 28B). The shape, size, position, and number of the urine drainage ports 28a can be set arbitrarily.

[0162] The urinary catheter lumen 402 is provided so that the axis Ax of the shaft 22j is located within the urinary catheter lumen 402. The distal end of the urinary catheter lumen 402 is located distal to the urinary catheter opening 28a within the shaft 22j, and the proximal end of the urinary catheter lumen 402 opens at the proximal end of the shaft 22j. The urinary catheter lumen 402 communicates with the urinary catheter opening 28a.

[0163] The side lumen 406 extends along the axial direction of the shaft 22j in parallel to the urinary catheterization lumen 402. The tip of the side lumen 406 opens into the tip surface (hemispherical surface) of the shaft 22j, and the base end of the side lumen 406 opens into the base end of the shaft 22j. An opening 426 at the tip of the side lumen 406 is blocked by a blocking member 407. The cross-sectional area of ​​the side lumen 406 is smaller than the flow path cross-sectional area of ​​the urinary catheterization lumen 402.

[0164] A partition wall 408 is provided between the urinary drainage lumen 402 and the side lumen 406, extending along the urinary drainage lumen 402. A through-hole 410 is provided at the tip of the partition wall 408, allowing the urinary drainage lumen 402 and the side lumen 406 to communicate with each other.

[0165] A urinary drainage opening 28a opens into the inner surface of the tip of the side lumen 406. That is, the side lumen 406 communicates with the urinary drainage opening 28a without passing through the urinary drainage lumen 402. In other words, the urinary drainage opening 28a is positioned so as to straddle both the urinary drainage lumen 402 and the side lumen 406. That is, the urinary drainage opening 28a is provided so that its center P is located closer to the side lumen 406 than the axis Ax of the shaft 22j. When the urinary drainage opening 28a straddles both the urinary drainage lumen 402 and the side lumen 406 in this way, the process of forming the urinary drainage opening 28a and the process of forming the through-hole 410 can be performed simultaneously, thereby reducing the number of steps required to manufacture the urinary catheter 18j.

[0166] The portion of the lateral lumen 406 proximal to the through-hole 410 functions as a sensor lumen 412 in which an oxygen sensor 400a and a temperature sensor 404 are disposed. The portion of the lateral lumen 406 distal to the sensor lumen 412 functions as a lateral urinary drainage lumen 414 through which urine flowing in from the urinary drainage opening 28a flows. In the following description, the urinary drainage lumen 402, the through-hole 410, and the lateral urinary drainage lumen 414 may be collectively referred to as a urinary tract 416. That is, urine flowing in from the urinary drainage opening 28a flows through the urinary tract 416. In addition, the region of the urinary tract 416 where the urinary drainage opening 28a is located (the distal end of the urinary drainage lumen 402, the through-hole 410, and the lateral urinary drainage lumen 414) may be referred to as a first urinary tract section 418, and the region of the urinary tract 416 proximal to the through-hole 410 may be referred to as a second urinary tract section 420.

[0167] As shown in FIGS. 27 and 28, the sensor lumen 412 is shorter than the urine drainage lumen 402. The oxygen sensor 400a disposed in the sensor lumen 412 is configured as a so-called fluorescent oxygen sensor and includes an oxygen sensor main body 422a (oxygen probe) capable of detecting oxygen in urine and a transmission unit 424 (oxygen transmission unit) optically connected to the oxygen sensor main body 422a. The oxygen sensor main body 422a includes a glass optical fiber or a plastic optical fiber. In this case, the core of the optical fiber is exposed at the distal end surface of the oxygen sensor main body 422a. However, the oxygen sensor 400a may also be configured as an electrode-type oxygen sensor. In this case, the transmission unit 424 is electrically connected to the oxygen sensor main body 422a. However, the transmission unit 424 may be magnetic or mechanical, rather than being limited to optical or electrical types.

[0168] The oxygen sensor main body 422a is located in the lateral urinary drainage lumen 414 (urinary tract 416). Specifically, the oxygen sensor main body 422a is located closer to the base end than the center of the urinary drainage opening 28a and is adjacent to the urinary drainage opening 28a in a direction perpendicular to the axial direction of the shaft 22j. That is, the oxygen sensor main body 422a is adjacent to the base end side of the urinary drainage opening 28a. In other words, the oxygen sensor main body 422a is adjacent to the through-hole 410 in a direction perpendicular to the axial direction of the shaft 22j. That is, the oxygen sensor main body 422a is not exposed to the outside of the shaft 22j.

[0169] The transmission unit 424 is a cable for optically connecting the oxygen sensor main body 422a and the monitoring system 16. The transmission unit 424 is optically connected to the oxygen sensor main body 422a via an opening 426 on the tip side of the sensor lumen 412. In the illustrated example, the opening 426 of the sensor lumen 412 is oriented in the axial direction (tip side) of the shaft 22j. The opening area of ​​the opening 426 of the sensor lumen 412 is smaller than the opening area of ​​the urinary drainage port 28a. Furthermore, the opening 426 of the sensor lumen 412 is positioned in a direction perpendicular to the axial direction of the shaft 22j with respect to the urinary drainage port 28a.

[0170] The temperature sensor 404 disposed in the sensor lumen 412 has a temperature sensor main body 428 (temperature probe) for detecting the temperature of urine flowing through the urinary tract 416, and a transmission part 430 (temperature transmission part) electrically connected to the temperature sensor main body 428.

[0171] The temperature sensor main body 428 is located between the oxygen sensor main body 422a and the balloon 24. That is, when the urinary catheter 18j is in use, the temperature sensor main body 428 is located inside the bladder 140. The transmission unit 430 is a cable for electrically connecting the temperature sensor main body 428 and the monitoring system 16. The transmission unit 430 is arranged in parallel with the transmission unit 424 inside the sensor lumen 412.

[0172] The position of the temperature sensor main body 428 can be set arbitrarily. For example, the temperature sensor main body 428 may be adjacent to the oxygen sensor main body 422a in a direction perpendicular to the axial direction of the shaft 22j. That is, the temperature sensor main body 428 may be located inside the urinary tract 416. Furthermore, the transmission unit 424 and the transmission unit 430 may be integrated into a single cable inside or outside the sensor lumen 412. In this case, the wiring of the transmission unit 424 and the transmission unit 430 can be simplified.

[0173] A fixing portion 432a (distal side fixing portion) for fixing the oxygen sensor 400a and the temperature sensor 404 to the inner surface constituting the sensor lumen 412 is provided within the sensor lumen 412. The fixing portion 432a is provided at the distal end of the sensor lumen 412. The fixing portion 432a is in liquid-tight contact with the inner surface of the sensor lumen 412 so as to prevent urine from flowing from the urinary tract 416 to the proximal side of the fixing portion 432a in the sensor lumen 412.

[0174] Specifically, fixed part 432a is made of a flexible material, and is fitted liquid-tightly into the tip of sensor lumen 412 with the tip of transmission part 424 liquid-tightly inserted into insertion hole 434 of fixed part 432a and the tips of temperature sensor main body 428 and transmission part 430 inserted into hole 436 of fixed part 432a. The tip of insertion hole 434 is located near urine drainage port 28a and oxygen sensor main body 422a.

[0175] The fixing portion 432a is made of the same material or a material of the same quality as that of the shaft 22j. The same material refers to silicone or an adhesive containing silicone. The fixing portion 432a may also be fixed to the inner surface of the sensor lumen 412 with an adhesive. The flow path cross-sectional area (transverse area perpendicular to the axial direction of the shaft 22j) of the first urinary tract portion 418 is larger than the flow path cross-sectional area (transverse area) of the second urinary tract portion 420 (see FIGS. 29A and 29B).

[0176] 27, the expansion lumen 32 is provided in the wall of the urinary catheterization lumen 402 on the opposite side to the side lumen 406. The distal end of the expansion lumen 32 communicates with the interior of the balloon 24, and the proximal end of the expansion lumen 32 opens into the proximal end of the shaft 22j.

[0177] The hub 26a is integrally molded into a hollow shape from a resin material. The hub 26a is provided with a urination port 70, a balloon expansion port 72, and a sensor placement port 438. The transmission unit 424 and the transmission unit 430 are inserted into the sensor placement port 438. The oxygen transmission unit 424 and the transmission unit 430 are electrically and / or optically connected to a transmission cable 441 via a connector 439 outside the hub 26a (see FIG. 26). The transmission cable 441 is electrically and / or optically connected to the monitor main body 94.

[0178] In the oxygen measuring device 10L described above, the oxygen sensor main body 422a is located inside the urinary tract 416. This allows the oxygen sensor main body 422a to come into contact with urine flowing through the urinary tract 416. This makes it possible to accurately and reliably measure oxygen in new urine that passes from the kidneys through the bladder 140 and is excreted outside the body via the urinary catheter 18j, rather than urine that remains in the bladder 140. Furthermore, the fixing portion 432a can suppress displacement of the oxygen sensor main body 422a relative to the shaft 22j, thereby improving the measurement accuracy of the oxygen sensor 400a.

[0179] Furthermore, since transmitting portion 424 and transmitting portion 430 are disposed in sensor lumen 412, it is possible to prevent transmitting portion 424 and transmitting portion 430 from interfering with the flow of urine in urinary tract 416. Therefore, urine in urinary tract 416 can flow (urinate) smoothly.

[0180] Furthermore, since the tip of oxygen sensor 400a (the end of transmission part 424 on the oxygen sensor main body 422a side) is fixed to the inner surface constituting sensor lumen 412 by fixing part 432a, displacement of oxygen sensor main body 422a relative to shaft 22j can be efficiently suppressed, thereby improving the measurement accuracy of oxygen sensor 400a.

[0181] Furthermore, since the tip of the temperature sensor 404 is fixed to the inner surface of the sensor lumen 412 by the fixing portion 432a, displacement of the temperature sensor main body 428 relative to the shaft 22j can be effectively suppressed, thereby improving the measurement accuracy of the temperature sensor 404.

[0182] Furthermore, fixed portion 432a prevents urine from flowing from urinary tract 416 to the proximal side of fixed portion 432a in sensor lumen 412. In other words, fixed portion 432a is provided so as to seal the distal end of sensor lumen 412 with transmitting portion 424 inserted therethrough. This allows urine to circulate efficiently within urinary tract 416. Also, since the area around oxygen sensor main body 422a can be filled with urine, urine circulating within urinary tract 416 can be reliably brought into contact with oxygen sensor main body 422a.

[0183] According to the oxygen measuring device 10L, the fixing part 432a is made of a flexible material, which allows the shaft 22j to be smoothly inserted into the bladder 140. In the oxygen measuring device 10L, the fixing part 432a is located inside the sensor lumen 412, which prevents the fixing part 432a from interfering with the flow of urine in the urinary tract 416.

[0184] In the oxygen measuring device 10L, the flow path cross-sectional area of ​​the urinary path 416 is larger than the cross-sectional area of ​​the sensor lumen 412, so that urine can flow through the urinary path 416 more smoothly.

[0185] Furthermore, because at least a portion of the urinary tract 416 extends along the axial direction of the shaft 22j so as to be parallel to the sensor lumen 412, it is possible to relatively reduce changes in the shape and rigidity of the shaft 22j in the longitudinal direction. This makes it possible to prevent the shaft 22j from buckling or the urinary tract 416 from being blocked when the shaft 22j is inserted into the bladder 140, thereby enabling a stable flow of urine through the urinary tract 416.

[0186] According to the oxygen measuring device 10L, the sensor lumen 412 has an opening 426 for exposing the oxygen sensor main body 422a to the inside of the urinary tract 416. Therefore, the oxygen sensor main body 422a can be disposed in the urinary tract 416 while the transmission section 424 is disposed in the sensor lumen 412.

[0187] Furthermore, since the opening 426 at the tip end of the sensor lumen 412 is oriented in the axial direction of the shaft 22j, the oxygen sensor main body 422a can be positioned within the urinary tract 416 without bending the transmission section 424.

[0188] In the oxygen measuring device 10L, the flow path cross-sectional area of ​​the first urinary tract portion 418 is larger than the flow path cross-sectional area of ​​the second urinary tract portion 420, so that urine in the bladder 140 can efficiently flow from the urinary drainage opening 28a into the first urinary tract portion 418. Furthermore, because the oxygen sensor main body 422a is located in the first urinary tract portion 418, urine that flows from the inside of the bladder 140 into the first urinary tract portion 418 via the urinary drainage opening 28a can reliably come into contact with the oxygen sensor main body 422a.

[0189] Furthermore, since the tip of the insertion hole 434 of the fixing part 432a is located near the urinary drainage opening 28a, the oxygen sensor main body 422a can be easily positioned near the urinary drainage opening 28a.

[0190] According to the oxygen measuring device 10L, the oxygen sensor main body 422a is adjacent to the urinary drainage opening 28a, so that urine that has flowed into the urinary tract 416 from the urinary drainage opening 28a can be reliably brought into contact with the oxygen sensor main body 422a. Furthermore, because the oxygen sensor main body 422a is adjacent to the base end side of the urinary drainage opening 28a (is not located inside the urinary drainage opening 28a), damage to the oxygen sensor main body 422a can be prevented even if the shaft 22j buckles at the position of the urinary drainage opening 28a.

[0191] Furthermore, since the oxygen sensor main body 422a is positioned in a direction perpendicular to the axial direction of the shaft 22j relative to the urinary drainage port 28a, urine that has flowed into the urinary tract 416 from the urinary drainage port 28a can be brought into efficient contact with the oxygen sensor main body 422a.

[0192] According to the oxygen measuring device 10L, the oxygen sensor main body 422a is located closer to the tip than the balloon 24, so the oxygen sensor main body 422a can be located inside the bladder 140. This makes it possible to detect oxygen in urine in a relatively stable environment (an environment with relatively little temperature change, etc.). In addition, the balloon 24 can hold the shaft 22j relative to the bladder 140, so displacement of the oxygen sensor main body 422a inside the bladder 140 can be suppressed.

[0193] According to the oxygen measuring device 10L, the center P of the urinary drainage opening 28a is located closer to the sensor lumen 412 than the axis Ax of the shaft 22j, so that the oxygen sensor main body 422a can be easily placed adjacent to the urinary drainage opening 28a. Furthermore, because the urinary drainage opening 28a is provided at a location on the shaft 22j that is closer to the tip end than the sensor lumen 412, urine that has flowed from inside the bladder 140 into the urinary tract 416 via the urinary drainage opening 28a can be reliably brought into contact with the oxygen sensor main body 422a.

[0194] The oxygen measurement system 12A may include oxygen measuring devices 10La to 10Lt described below instead of the oxygen measuring device 10L. In the oxygen measuring devices 10La to 10Lt, the same components as those in the oxygen measuring device 10L described above are given the same reference numerals, and detailed description thereof will be omitted. In the oxygen measuring devices 10La to 10Lt, the parts common to the oxygen measuring device 10L can provide the same or similar functions and effects as those of the oxygen measuring device 10La.

[0195] The shaft 22ja of the urinary catheter 18ja constituting the oxygen measuring device 10La shown in FIG. 30 has a fixing portion 440 (proximal-end fixing portion) at the proximal end of the sensor lumen 412. The fixing portion 440 is made of a flexible material and is fitted into the proximal end of the sensor lumen 412 with the proximal end of the transmission portion 424 inserted into the insertion hole 442 of the fixing portion 440 and the proximal end of the transmission portion 430 inserted into the insertion hole 444 of the fixing portion 440. In this case, even if an external force is applied to the transmission portion 424 and the transmission portion 430, displacement of the oxygen sensor main body 422a and the temperature sensor main body 428 relative to the shaft 22ja can be suppressed. This improves the measurement accuracy of the oxygen sensor main body 422a and the temperature sensor main body 428. The fixing portion 440 may be configured to be more flexible than the fixing portion 432a located at the distal end. This absorbs the expansion and contraction of the urinary catheter 18ja and prevents damage to the oxygen sensor 400a.

[0196] 31, a shaft 22jb of a urinary catheter 18jb constituting an oxygen measuring device 10Lb is provided with a fixed portion 432b instead of the fixed portion 432a. The fixed portion 432b extends over the entire length of the sensor lumen 412 so as to seal the entire sensor lumen 412. The fixed portion 432b is made of a flexible material, and is fixed to the wall surface constituting the sensor lumen 412 with the transmission portion 424 inserted into an insertion hole 448 of the fixed portion 432b and the transmission portion 430 inserted into a hole 450 of the fixed portion 432b. With this configuration, displacement of the oxygen sensor main body 422a and the temperature sensor main body 428 relative to the shaft 22jb can be effectively suppressed.

[0197] The partition wall 408 (see FIG. 27) described above is omitted from the shaft 22jc of the urinary catheter 18jc constituting the oxygen measuring device 10Lc shown in FIGS. 32 and 33. That is, the shaft 22jc does not have the side lumen 406 shown in FIG. 27, but has a urinary catheter lumen 452. In this case, the urinary catheter lumen 452 functions as a urinary tract 454. The oxygen sensor 400a and the temperature sensor 404 are disposed in the urinary tract 454. The urinary tract 454 is provided with a fixing portion 432c that fixes the tip of the transmission portion 424 and the tip of the temperature sensor 404 (tips of the temperature sensor main body 428 and the transmission portion 430) to a wall surface constituting the urinary tract 454. In the urinary catheter 18jc, a seal member 458 is disposed in the sensor placement port 438 to prevent urine in the urinary tract 454 from leaking to the outside via the sensor placement port 438.

[0198] Furthermore, fixed portion 432c is spaced apart from the inner surface of urinary tract 454 that faces fixed portion 432c. In other words, fixed portion 432c is spaced apart from a portion of the inner surface that constitutes urinary tract 454 that faces a portion with which fixed portion 432c is in contact. This makes it possible to prevent fixed portion 432c from interfering with the flow of urine in urinary tract 454, thereby allowing urine to flow smoothly in urinary tract 454.

[0199] The shaft 22jd of the urinary catheter 18jd constituting the oxygen measuring device 10Ld shown in Fig. 34 is provided with a fixing part 432d instead of the fixing part 432c of the urinary catheter 18jc shown in Fig. 32. The fixing part 432d is provided so as to cover the transmitting part 424 and the temperature sensor 404 inside the urinary tract 454. In this case, urine can flow more smoothly inside the urinary tract 454.

[0200] In the shaft 22je of the urinary catheter 18je constituting the oxygen measuring device 10Le shown in FIG. 35, the flow path cross-sectional area of ​​the second urinary tract section 420 gradually increases toward the base end. With this configuration, urine in the second urinary tract section 420 can flow smoothly toward the base end of the shaft 22je. In the urinary catheter 18je, the flow path cross-sectional area of ​​the second urinary tract section 420 may increase in stages toward the base end. That is, it is sufficient that the flow path cross-sectional area of ​​the second urinary tract section 420 on the base end side is larger than the flow path cross-sectional area on the tip end side.

[0201] In the shaft 22jf of the urinary catheter 18jf constituting the oxygen measuring device 10Lf shown in Fig. 36A, a recess 462 is provided on the surface of the fixing part 432a that is exposed to the urinary tract 416 side, and the oxygen sensor main body 422a is located in the recess 462. Furthermore, the urinary catheter 18jf does not include the above-mentioned blocking member 407 (see Fig. 27). Therefore, urine in the bladder 140 also flows in through an opening 464 on the tip side of the lateral lumen 406.

[0202] With this configuration, urine flowing through the urinary tract 416 can be reliably brought into contact with the oxygen sensor main body 422a. In this urinary catheter 18jf, the oxygen sensor main body 422a may be located outside the recess 462 in the urinary tract 416.

[0203] In the shaft 22jg of the urinary catheter 18jg constituting the oxygen measuring device 10Lg shown in Fig. 36B, an oxygen sensor 400b and a urinary drainage port 28d are provided instead of the oxygen sensor 400a and the urinary drainage port 28a shown in Fig. 36A. The oxygen sensor main body 422b of the oxygen sensor 400b extends further to the tip side than the urinary drainage port 28d.

[0204] Additionally, a fixing portion 432e is provided within side lumen 406 to fix the tip of oxygen sensor main body 422b to the inner surface that forms the tip of side lumen 406. Fixing portion 432e seals the tip of side lumen 406. Urinary drainage port 28d differs from urine drainage port 28a in that it is rectangular. With this configuration, displacement of oxygen sensor main body 422b relative to shaft 22jg can be effectively suppressed.

[0205] In the shaft 22jh of the urinary catheter 18jh constituting the oxygen measuring device 10Lh shown in Fig. 37A, a urinary drainage port 28e is provided instead of the urinary drainage port 28a shown in Fig. 36A. The urinary drainage port 28e communicates only with the urinary drainage lumen 402 and does not extend across to the side lumen 406. Furthermore, the urinary drainage lumen 402 and the side lumen 406 do not communicate with each other. Therefore, the entire urinary drainage lumen 402 functions as a urinary tract 474, and urine does not flow into the side lumen 406 further distal than the sensor lumen 412.

[0206] An opening 476 for positioning the oxygen sensor main body 422a in the urinary tract 474 is formed through the partition wall 408. That is, the opening 476 is oriented in a direction perpendicular to the axial direction of the shaft 22jh. The transmitting section 424 is bent toward the urinary tract 474 at its tip end and extends into the urinary tract 474 through the opening 476. The oxygen sensor main body 422a is located closer to the base end than the urinary drainage port 28e within the urinary tract 474.

[0207] 36A, a fixing portion 432f is provided in shaft 22jh. Fixing portion 432f is provided to seal the distal end side of side lumen 406 (the distal end side of sensor lumen 412) and to seal opening 476. Fixing portion 432f fixes the distal end of transmitter 424 and the distal end of temperature sensor 404 to the inner surface that constitutes sensor lumen 412.

[0208] With this configuration, the oxygen sensor main body 422a is located closer to the base end than the urinary drainage opening 28e, so that even if the shaft 22jh buckles at the position of the urinary drainage opening 28e, damage to the oxygen sensor main body 422a can be reliably prevented. Furthermore, urine flowing through the urinary tract 474 from the urinary drainage opening 28e to the base end can be reliably brought into contact with the oxygen sensor main body 422a.

[0209] The shaft 22ji of the urinary catheter 18ji constituting the oxygen measuring device 10Li shown in Fig. 37B differs from the urinary catheter 18jh shown in Fig. 37A only in that the fixing part 432f is configured so as not to block the opening 476, and the oxygen sensor main body 422a is positioned inside the opening 476. With this configuration, the same effects as those of the urinary catheter 18jh shown in Fig. 37A can be achieved.

[0210] In the shaft 22jj of the urinary catheter 18jj constituting the oxygen measuring device 10Lj shown in Fig. 38A, a urinary drainage opening 28f and a fixing part 432g are provided instead of the urinary drainage opening 28a and fixing part 432a shown in Fig. 36A. The urinary drainage opening 28f communicates only with the urinary drainage lumen 402 and the through-hole 410, and does not extend across to the side lumen 406.

[0211] The fixing portion 432g is provided with a recess 482 for exposing the oxygen sensor main body 422a to the inside of the urinary tract 416. The inside of the recess 482 is in communication with the urine drainage port 28f via the through-hole 410.

[0212] In such a shaft 22jj, the distal end side of the urinary catheterization lumen 402, the through-hole 410, and the recess 482 function as a first urinary tract section 484, and the proximal end side of the urinary catheterization lumen 402 from the through-hole 410 functions as a second urinary tract section 420. The first urinary tract section 484 and the second urinary tract section 420 form a urinary tract 486. The fixing section 432g fixes the distal end of the transmitter 424 and the distal end of the temperature sensor 404 to the inner surface that forms the sensor lumen 412. This configuration allows the oxygen sensor main body 422a to come into contact with urine flowing through the urinary tract 486.

[0213] In the shaft 22jk of the urinary catheter 18jk constituting the oxygen measuring device 10Lk shown in Fig. 38B, a urinary drainage port 28g is provided instead of the urinary drainage port 28a shown in Fig. 27. The urinary drainage port 28g extends across the urinary drainage lumen 402 and the through-hole 410, and is not located on the inner surface constituting the side lumen 406. In addition, in the axial direction of the shaft 22jk, the tip of the side lumen 406 is at the same position as the tip of the urinary drainage lumen 402. In other words, the side lumen 406 does not penetrate all the way to the tip of the shaft 22jk.

[0214] The transmitting section 424 is curved toward the urinary catheterization lumen 402 in the urinary tract 416, and the oxygen sensor main body 422a is located inside the urinary catheterization lumen 402. Specifically, the oxygen sensor main body 422a is adjacent to the urinary catheterization port 28g in a direction perpendicular to the axial direction of the shaft 22jk. The fixing section 432a extends further to the tip side than the partition wall 408. This configuration allows the oxygen sensor 400a to come into contact with urine flowing through the urinary tract 416.

[0215] The shaft 22jl of the urinary catheter 18jl constituting the oxygen measuring device 10Ll shown in Fig. 39A has a tip end with a different shape from that of the shaft 22j described above. The curvature of the tip end surface of the shaft 22jl is greater than that of the tip end surface of the shaft 22jl. Furthermore, the shaft 22jl is provided with an elliptical urine drainage port 28h instead of the urine drainage port 28a shown in Fig. 27. This configuration allows the oxygen sensor 400a to come into contact with urine flowing through the urinary tract 416.

[0216] In the shaft 22jm of the urinary catheter 18jm constituting the oxygen measuring device 10Lm shown in Fig. 39B, an opening 488 is provided in the partition wall 408 for positioning the oxygen sensor main body 422a in the urinary catheter lumen 402. That is, the opening 488 is oriented in a direction perpendicular to the axial direction of the shaft 22jm. The transmitting section 424 is bent toward the urinary tract 416 at the tip end and extends into the urinary tract 416 through the opening 488. Therefore, the oxygen sensor main body 422a is located closer to the base end than the urinary catheter opening 28a within the second urinary tract section 420.

[0217] With this configuration, even when the amount of urine excreted is relatively small, urine flowing through the urinary tract 416 can be reliably brought into contact with the oxygen sensor main body 422a.

[0218] The shaft 22jn of the urinary catheter 18jn constituting the oxygen measuring device 10Ln shown in Fig. 40A has an open tip and a hole 490 (through-hole) on the outer peripheral surface on the tip side. The opening 492 at the tip of the shaft 22jn is closed by a closing member 494. The closing member 494 may be formed integrally with the shaft 22jn. The hole 490 faces the through-hole 410.

[0219] 27, the shaft 22jn is provided with an oxygen sensor 400c, a urine drainage port 28i, and a fixing portion 432h (adhesive). The oxygen sensor main body 422c of the oxygen sensor 400c extends along the axial direction of the shaft 22jn to the distal end side of the urine drainage port 28i. The urine drainage port 28i communicates with the urine drainage lumen 402 and does not straddle the through-hole 410 or the lateral lumen 406. In other words, the urine drainage port 28i communicates with the lateral urine drainage lumen 414 via the urine drainage lumen 402 and the through-hole 410. The urine drainage port 28i extends distally and proximally beyond the through-hole 410. In other words, the through-hole 410 and the hole 490 are positioned in a direction perpendicular to the axial direction of the shaft 22jn with respect to the urine drainage opening 28i.

[0220] The fixing portion 432h fixes the oxygen sensor 400c to the shaft 22jn with the hole 490 closed. Specifically, the fixing portion 432h is provided at the distal end and proximal end of the oxygen sensor main body 422c and the transmission portion 424. This allows the oxygen sensor main body 422c to be effectively held within the lateral urinary drainage lumen 414. A portion of the intermediate portion in the extension direction of the oxygen sensor main body 422c that faces the through-hole 410 is exposed to the lateral urinary drainage lumen 414. The fixing portion 432h may be provided at only one of the distal end and proximal end of the oxygen sensor main body 422c.

[0221] With this configuration, the fixing part 432h can be easily provided in the side lumen 406 through the hole 490 provided on the outer peripheral surface of the shaft 22jn. This reduces the number of steps required to manufacture the urinary catheter 18jn. Furthermore, because the hole 490 is closed by the fixing part 432h, urine that has flowed into the urinary tract 416 from the urinary drainage opening 28i does not flow out of the urinary catheter 18jn through the hole 490.

[0222] The shaft 22jo of the urinary catheter 18jo constituting the oxygen measuring device 10Lo shown in Fig. 40B differs from the urinary catheter 18jn shown in Fig. 40A in that the through-hole 410 and the hole 490 are located closer to the base end than the urinary drainage opening 28i. Furthermore, in the axial direction of the shaft 22jo, the tip of the oxygen sensor main body 422c is located at the base end of the urinary drainage opening 28i. This configuration provides the same effects as the urinary catheter 18jn shown in Fig. 40A.

[0223] The shaft 22jp of the urinary catheter 18jp constituting the oxygen measuring device 10Lp shown in Fig. 41A is provided with a urinary drainage port 28j and a fixing portion 432i (adhesive) instead of the urinary drainage port 28i and fixing portion 432h, as compared to the urinary catheter 18jn shown in Fig. 40A. The urinary drainage port 28j spans the urinary drainage lumen 402 and the through-hole 410, but does not span the lateral lumen 406. The through-hole 410 extends to the proximal end of the urinary drainage port 28j, and the hole 490 is located closer to the proximal end than the urinary drainage port 28j. In addition, in the axial direction of the shaft 22jp, the tip of the oxygen sensor main body 422c is located closer to the proximal end of the urinary drainage port 28j.

[0224] The fixing portion 432i closes the hole 490 and is provided at the base end of the oxygen sensor main body 422c and the transmitting portion 424. Such a configuration provides the same effects as the urinary catheter 18jn shown in Fig. 40A.

[0225] The shaft 22jq of the urinary catheter 18jq constituting the oxygen measuring device 10Lq shown in FIG. 41B is provided with a urinary drainage port 28k instead of the urinary drainage port 28j, as compared to the urinary catheter 18jp shown in FIG. 41A. The urinary drainage port 28k spans the urinary drainage lumen 402, the through-hole 410, and the lateral urinary drainage lumen 414. In addition, in the axial direction of the shaft 22jq, the tip of the oxygen sensor main body 422c is located at the base end of the urinary drainage port 28k. The hole 490 is located closer to the base end than the urinary drainage port 28k and the through-hole 410. This configuration provides the same effects as the urinary catheter 18jn shown in FIG. 40A.

[0226] The shaft 22jr of the urinary catheter 18jr constituting the oxygen measuring device 10Lr shown in Fig. 42A differs from the urinary catheter 18jc shown in Fig. 32 in that a fixing part 432j is provided instead of the fixing part 432c. The fixing part 432j has a support part 496 protruding from the inner surface of the urinary catheter lumen 452, and an engagement part 498 (fixing part) for fixing the transmitting part 424 to the support part 496. The support part 496 has an insertion hole 500 through which the transmitting part 424 is inserted.

[0227] The engaging portion 498 is fixed to the outer peripheral surface of the transmission portion 424 and also to the inner surface that defines the insertion hole 500. This ensures that the oxygen sensor 400a is securely fixed to the shaft 22jr. In other words, the engaging portion 498 maintains a constant distance between the oxygen sensor main body 422a and the support portion 496.

[0228] The support portion 496 may be rigid or flexible. If the support portion 496 is flexible, as shown in FIG. 42B , the support portion 496 can be elastically deformed even when the transmission portion 424 is pulled toward the base end, for example, and therefore damage to the oxygen sensor 400a can be prevented. In this case, the support portion 496 and the engagement portion 498 may move relatively in the axial direction of the shaft 22jr. The support portion 496 and the engagement portion 498 may be made of the same material or different materials.

[0229] The shaft 22js of the urinary catheter 18js constituting the oxygen measuring device 10Ls shown in FIG. 43A differs from the urinary catheter 18jr shown in FIG. 42A in that a fixing portion 432k is provided instead of the fixing portion 432j. The fixing portion 432k has a support portion 502 protruding from the inner surface of the urinary catheter lumen 452 and an engaging portion 504 for engaging the transmission portion 424 with the support portion 502. The support portion 502 has an insertion hole 506 through which the transmission portion 424 is inserted. The inner surface of the insertion hole 506 has a recess 508 in which the engaging portion 504 is disposed. Even with this configuration, the oxygen sensor 400a can be fixed to the shaft 22js. Note that, although the engaging portion 504 is not fixed to the inner surface of the recess 508 in the illustrated example, it may be fixed to the inner surface of the recess 508.

[0230] The shaft 22jt of the urinary catheter 18jt constituting the oxygen measuring device 10Lt shown in Fig. 43B differs from the urinary catheter 18j shown in Fig. 27 in that the insertion hole 434 of the fixing part 432a is located on the urinary lumen 402 side. In other words, the insertion hole 434 is provided on the outer surface of the fixing part 432a on the urinary lumen 402 side. That is, the tip surface of the inner surface constituting the sensor lumen 412 on the urinary lumen 402 side (the tip surface of the partition wall 408 on the sensor lumen 412 side) is located within the insertion hole 434. Therefore, the transmitting part 424 is in contact with the tip surface. This allows the oxygen sensor main body 422a to be positioned on the urinary lumen 402 side.

[0231] The present invention is not limited to the above-described configuration. The urine drainage ports 28a-28k may be one or three or more, and their openings may not face each other or may be located at the tips of the blocking portions 23a-23e. The oxygen measuring devices 10A-10J may include a shaft 22k shown in FIG. 44. As shown in FIG. 44, the shaft 22k may be provided with a hard member 600 made of a material harder than the material of the shaft 22k. The hard member 600 may be made of, for example, metal, plastic, or fiber. The hard member 600 includes embedded hard portions 602a and 602b embedded in the wall of the shaft 22k, a hard wall portion 604a provided on the wall surface that forms the urine drainage lumen 42, a hard wall portion 604b provided on the wall surface that forms the sensor lumen 202, and a hard wall portion 604c provided on the wall surface that forms the expansion lumen 32. The embedded hard portions 602a, 602b extend linearly. The outer surfaces of the embedded hard portions 602a, 602b and the wall hard portions 604a-604c may or may not have unevenness. The embedded hard portions 602a, 602b and the wall hard portions 604a-604c may be strip-shaped members with multiple holes. The embedded hard portions 602a, 602b may be configured in a mesh (net) shape, or may be a braided material made of densely combined fibers or the like. The shaft 22k may be provided with at least one of the embedded hard portions 602a, 602b and the wall hard portions 604a-604c. According to this configuration, the expansion and contraction of the shaft 22k can be suppressed by the hard member 600, so that misalignment between the oxygen sensor main bodies 50a to 50h, 50ha, 50hb and the optical fiber 58 due to expansion and contraction of the shaft 22k can be suppressed.

[0232] The oxygen measuring devices 10A to 10L and 10La to 10Lt may include a shaft 22l shown in Fig. 45A. As shown in Fig. 45A, a urinary catheterization lumen 609 is provided in the center of the shaft 22l. A first sensor lumen 610 in which the transmitting unit 52, the transmitting unit 304, or the transmitting unit 424 is disposed is provided on one side of the urinary catheterization lumen 609 in the shaft 22l.

[0233] On the other side of the urinary catheterization lumen 609 in the shaft 22l (the side opposite to the first sensor lumen 610), there are provided a second sensor lumen 612 in which a temperature sensor 44 or a temperature sensor 404 is disposed, and an expansion lumen 32 adjacent to the second sensor lumen 612. By providing the first sensor lumen 610 and the second sensor lumen 612 in this way, the degree of freedom in sensor placement can be improved.

[0234] The oxygen measuring devices 10A to 10L and 10La to 10Lt may include a shaft 22m shown in FIG. 45B. As shown in FIG. 45B, the shaft 22m has a urinary catheterization lumen 609 with a semicircular cross section provided at a position displaced from the center of the shaft 22m. A first sensor lumen 610 and a second sensor lumen 612 are provided on the same side of the urinary catheterization lumen 609. The first sensor lumen 610 and the second sensor lumen 612 are arranged side by side in the width direction of the urinary catheterization lumen 609 (the extension direction of the chord of the cross section of the urinary catheterization lumen 609, the left-right direction in FIG. 27B). The expansion lumen 32 is provided on the opposite side of the urinary catheterization lumen 609 with respect to the first sensor lumen 610 and the second sensor lumen 612.

[0235] Oxygen measuring devices 10A to 10L and 10La to 10Lt may include shaft 22n shown in Fig. 45C. As shown in Fig. 45C, shaft 22n differs from shaft 22m shown in Fig. 45B in that it is provided with one sensor lumen 614 instead of first sensor lumen 610 and second sensor lumen 612. In this case, within sensor lumen 614, transmitting unit 52, transmitting unit 304, or transmitting unit 424 and temperature sensor 44 or temperature sensor 404 are provided side by side.

[0236] The oxygen measuring devices 10A-10L, 10La-10Lt may be provided with a temperature sensor capable of detecting the temperature of urine at the proximal end of the urinary catheters 18a-18j, 18ja-18jt in addition to the above-mentioned temperature sensors 44, 404 provided at the tip portions of the urinary catheters 18a-18j, 18ja-18jt. The oxygen measuring devices 10A-10L, 10La-10Lt may be provided with a pressure sensor that measures the pressure near the tip of the urinary catheters 18a-18j, 18ja-18jt. The pressure sensor outputs an electrical signal or an optical signal to the monitoring system 16.

[0237] The monitor main body 94 may be configured to be able to acquire time, atmospheric pressure around the monitor main body 94, humidity around the monitor main body 94, and temperature around the monitor main body 94. Note that time includes the current time and the elapsed time from a certain timing. The monitor main body 94 may be configured to read and reflect the initial (manufacturing) calibration value specific to each sensor. The calibration values ​​may be input by scanning a one-dimensional or two-dimensional barcode, or may be input directly from the monitor 114. Alternatively, the calibration values ​​may be stored in the signal output units of the urinary catheters 18a-18j, 18ja-18jt, and may be automatically read when the monitoring system 16 is connected to the urinary catheters 18a-18j, 18ja-18jt.

[0238] The oxygen measurement system 12, 12A may be checked for operation before use. In this case, it is confirmed that the output values ​​from the sensors of the oxygen measuring devices 10A-10L, 10La-10Lt are within the normal operating range. Specifically, the output values ​​from the sensors of the oxygen measuring devices 10A-10L, 10La-10Lt are compared with reference values ​​calculated from the temperature, humidity, and atmospheric pressure around the monitor main body 94. The control unit 116 of the monitor main body 94 then determines whether the output values ​​from the sensors of the oxygen measuring devices 10A-10L, 10La-10Lt are within the normal range and notifies the user of the result of the determination. It is also possible to confirm that the output values ​​from the sensors of the oxygen measuring devices 10A-10L, 10La-10Lt are within the normal range by using a reference solution or gas to obtain the output values ​​of each sensor and comparing the output values ​​with the reference values.

[0239] The monitor main body 94 may report various physical quantities (oxygen partial pressure, bladder temperature, urine volume, etc.) based on output values ​​from the sensors of the oxygen measuring devices 10A-10L, 10La-10Lt. Specifically, the monitor main body 94 can report the physical quantities using numerical values, bar graphs, dial gauges, level meters, colors, etc. The monitor main body 94 can also display the progress of the physical quantities on the monitor 114 using up and down arrows, various graphs (line graphs, etc.), color change progress indicators, etc.

[0240] There is a time lag before a change in the bladder 140 appears as a change in the urine flow rate in the oxygen measuring devices 10A-10L, 10La-10Lt. Therefore, the monitor main body 94 may be configured to display on the monitor 114 the delay time until the change in the bladder 140 appears as an output value of each sensor in the oxygen measuring devices 10A-10L, 10La-10Lt.

[0241] The user can set predetermined conditions for the monitor main body 94. The monitor main body 94 may determine whether a set time has passed since the set conditions were met and may issue a notification. That is, the monitor main body 94 may issue a notification, for example, when a set amount of urine is not urinated, or when a set condition is met (such as a low output state of the sensor or a state in which the temperature inside the bladder is lower than a set temperature) for a set time or longer.

[0242] The monitor main body 94 may determine that a set change has occurred and issue an alert. That is, the monitor main body 94 may issue an alert, for example, when the rate of change in the urine flow rate exceeds a set rate of change, or when the range of change in the measured urine temperature exceeds a set range of change, etc.

[0243] The monitor main body 94 may have a function of storing a program internally and may be configured to be able to update the program by receiving update information from an external source. In this case, the monitor main body 94 may receive the update information by wirelessly or by wired connection (USB connection) to a source of the update information. The monitor main body 94 may also receive the update information by replacing a memory card.

[0244] The monitor main body 94 may be configured to allow easy operation of required functions. That is, the monitor main body 94 may be configured to have at least one physical function key and to allow functions to be freely assigned to each function key. The monitor main body 94 may be configured to allow a time-back operation to past data by, for example, operating a dial or sliding the monitor 114 (screen).

[0245] The monitor main body 94 may be configured so that the data in the selected range can be printed from an external printer or the like.

[0246] The monitor main body 94 may be configured to divide the display area of ​​the monitor 114 and display any data in each display area. In this case, for example, current data and past data can be easily compared. The monitor main body 94 may be configured to output the display of the monitor 114 to an external display device for display.

[0247] The monitor main body 94 may be configured to estimate the range of the urination volume from the infusion volume, compare the estimated range with the actual urination volume, determine whether or not the actual urination volume is within the estimated range, and notify the result of the determination. The infusion volume may be automatically acquired from the infusion pump, or may be input directly.

[0248] The above embodiment discloses an oxygen measuring device comprising a urethral catheter including a flexible hollow shaft, and an oxygen sensor having an oxygen sensor body capable of detecting oxygen in urine, wherein the shaft is provided with a urinary drainage port through which urine from the bladder flows, and a urinary tract that communicates with the urinary drainage port and through which the urine flows, the oxygen sensor is provided in the urethral catheter, and the oxygen sensor body is configured to come into contact with the urine flowing through the urinary tract.

[0249] With this configuration, the oxygen sensor body can be brought into contact with urine flowing through the urinary tract, making it possible to accurately and reliably measure the oxygen in fresh urine that is excreted from the kidneys through the bladder and out of the body.

[0250] In the above-mentioned oxygen measuring device, the oxygen sensor comprises an oxygen sensor body having a phosphor and a base on which the phosphor is provided, and an optical fiber formed separately from the oxygen sensor body, the oxygen sensor body being fixed to the urinary catheter so that at least a portion of the phosphor comes into contact with urine in the urinary tract, and the optical fiber being fixed to the urinary catheter with the tip surface of the optical fiber positioned relative to the phosphor so that excitation light can be irradiated to the phosphor and fluorescence from the phosphor can be received.

[0251] According to this configuration, the oxygen sensor body having the phosphor and the optical fiber can be manufactured separately and then incorporated into the urinary catheter, thereby making it possible to measure oxygen in urine.

[0252] In the above-mentioned oxygen measuring device, a tip opening of the lumen that constitutes the urinary tract may be formed at the tip of the shaft, the urethral catheter may have an obstructing portion fitted into the tip opening, and the oxygen sensor body may be fixed to the obstructing portion.

[0253] According to this configuration, by fitting the closing portion to which the oxygen sensor main body is fixed into the tip opening from the tip side of the shaft, the oxygen sensor main body can be accurately, easily and reliably assembled onto the shaft.

[0254] In the oxygen measuring device, the optical fiber may be fixed to the shaft so that a tip end surface of the optical fiber is located within the urinary tract and faces the phosphor.

[0255] According to this configuration, the excitation light from the optical fiber can be efficiently irradiated onto the phosphor, and the fluorescence from the phosphor can be efficiently received by the optical fiber.

[0256] In the above-mentioned oxygen measuring device, the optical fiber may be fixed to the urinary catheter in a state where it is folded back further distal than the urinary tract so that the tip surface of the optical fiber is positioned on the opposite side of the urinary tract from the oxygen sensor body, and the base may be configured to be transmissive to excitation light from the optical fiber and fluorescence from the fluorescent material.

[0257] With this configuration, it is possible to improve assembly ease and accuracy, and to measure oxygen in urine while preventing the tip end surface of the optical fiber from coming into contact with urine and becoming contaminated.

[0258] In the oxygen measuring device, the tip end surface of the optical fiber may be in contact with or in proximity to a surface of the base portion opposite to the surface on which the phosphor is applied.

[0259] With this configuration, the fluorescent material can be brought into contact with urine more reliably, light from the optical fiber can be efficiently irradiated onto the fluorescent material, and fluorescence from the fluorescent material can be efficiently received by the optical fiber.

[0260] In the oxygen measuring device, the blocking portion may be formed with an arrangement hole in which the folded back portion of the optical fiber is arranged.

[0261] With this configuration, the optical fiber can be easily placed in a folded state at the distal end side of the urinary tract.

[0262] In the oxygen measuring device, the optical fiber may be held in the blocking portion while being disposed in the disposition hole.

[0263] According to this configuration, when the blocking portion is fitted into the tip opening of the shaft, the optical fiber can be assembled to the shaft with high precision and the arrangement can be maintained more reliably.

[0264] In the above-mentioned oxygen measuring device, the oxygen sensor body may have a support portion fixed to the blocking portion, and the support portion may be provided with a positioning portion to which the base portion is fixed and which positions the tip of the optical fiber.

[0265] With this configuration, the tip end face of the optical fiber can be positioned with high precision relative to the phosphor. Also, the oxygen sensor main body can be fixed to the closing part by gripping the support part.

[0266] In the oxygen measuring device described above, the phosphor may be located closer to the tip than the urine drainage port, and the urine drainage port may be formed so that the opening width along the circumferential direction increases toward the tip of the shaft.

[0267] With this configuration, the flow of urine in the urinary tract is prevented from being obstructed by the fluorescent material, allowing urine to flow more efficiently toward the base end of the shaft, and urine introduced into the urinary tract from the urinary drainage opening can be efficiently guided to the fluorescent material located closer to the tip than the urinary drainage opening.

[0268] In the oxygen measuring device, the fluorescent material may be located on the proximal side of the urinary tract relative to the urinary drainage opening.

[0269] With this configuration, the fluorescent material can be brought into contact with urine flowing through the urinary tract reliably and efficiently.

[0270] In the above-mentioned oxygen measurement device, the base may be configured to allow excitation light from the optical fiber and fluorescence from the fluorescent material to pass through, and may extend in a direction perpendicular to the axis of the shaft so that the fluorescent material is located further distal than the base, and the optical fiber may be provided proximal to the base so that the distal end surface of the optical fiber faces the surface of the base opposite to the surface on which the fluorescent material is applied.

[0271] This configuration allows urine in the urinary tract to reliably and efficiently contact the fluorescent material, and also allows the fluorescent material to be efficiently irradiated with excitation light from the optical fiber, and the fluorescent material to be efficiently received by the optical fiber.

[0272] In the oxygen measuring device, the base may be configured in an annular shape.

[0273] With this configuration, urine in the urinary tract can flow smoothly in the direction of the base end of the shaft through the inner hole in the base portion.

[0274] In the oxygen measuring device, a wall surface constituting the urinary tract may have a holding hole formed therein into which an outer edge of the base is inserted.

[0275] According to this configuration, the base portion can be held in a state in which it extends in a direction perpendicular to the axis of the shaft with a simple configuration.

[0276] In the above-mentioned oxygen measuring device, the retaining hole may include a slit that opens to the outer surface of the shaft and is large enough to allow the oxygen sensor body to be inserted into the urinary tract from the outside of the shaft, and the oxygen sensor body may be fixed to the shaft by adhesive that is filled to seal the slit.

[0277] With this configuration, the oxygen sensor body can be easily and accurately assembled from the outside of the shaft.

[0278] In the above-mentioned oxygen measuring device, the oxygen sensor body may have a support portion fixed to the shaft, and the support portion may be provided with a positioning portion to which the base portion is fixed and which positions the tip of the optical fiber.

[0279] With this configuration, the tip end surface of the optical fiber can be positioned with high precision relative to the phosphor. Also, the oxygen sensor main body can be incorporated into the urinary tract by grasping the support portion.

[0280] In the above oxygen measuring device, a first engagement portion may be provided on the wall surface constituting the urinary tract, and a second engagement portion may be provided on the support portion that is positioned on the shaft by engaging with the first engagement portion.

[0281] With this configuration, the oxygen sensor body can be accurately incorporated into the urinary tract.

[0282] In the oxygen measuring device, the support portion may be configured in an annular shape, and the phosphor may be located in an inner hole of the support portion.

[0283] With this configuration, urine in the urinary tract can be brought into contact with the phosphor while flowing through the inner hole of the support part.

[0284] In the oxygen measuring device, the base portion may extend along the axial direction of the shaft.

[0285] With this configuration, the flow of urine through the inner hole of the support part is less likely to be obstructed by the base part, compared to when the base part extends in a direction perpendicular to the axis of the shaft.

[0286] In the above-mentioned oxygen measuring device, the phosphor is located in a direction intersecting the direction of the tip surface of the optical fiber, and the support part may be provided with a reflecting part that guides excitation light from the optical fiber to the phosphor and guides fluorescence from the phosphor into the optical fiber.

[0287] With this configuration, for example, the reflecting portion can irradiate the fluorescent material with excitation light from the optical fiber, and the optical fiber can receive fluorescence from the fluorescent material, without bending the optical fiber.

[0288] In the oxygen measuring device, the phosphor may extend in a direction toward the base end of the shaft and inclined inward of the shaft.

[0289] With this configuration, urine in the urinary tract can be brought into contact with the phosphor efficiently.

[0290] In the above oxygen measuring device, the oxygen sensor may have an optical fiber, and the optical fiber may be fixed to the urinary catheter by an adhesive that seals a through hole formed on the outer surface of the shaft.

[0291] According to this configuration, when the optical fiber is positioned and fixed to the urinary catheter, assembly is facilitated and the tip surface of the optical fiber is prevented from being soiled with adhesive.

[0292] In the oxygen measuring device, a sensor lumen in which the optical fiber is disposed may be formed in a wall of the shaft.

[0293] With this configuration, since the optical fiber is disposed in the sensor lumen, it is possible to prevent the optical fiber from interfering with the flow of urine in the urinary tract, thereby enabling the urine to flow smoothly in the urinary tract.

[0294] In the oxygen measuring device, the shaft may be provided with a hard member made of a material harder than the material of the shaft.

[0295] According to this configuration, for example, when the shaft is inserted into the urethra, deformation (expansion and contraction, etc.) of the shaft can be suppressed by the hard member, and therefore misalignment between the phosphor and the optical fiber can be suppressed.

[0296] In the oxygen measuring device, the oxygen sensor may have a transmission section that is integrally provided with the oxygen sensor body at a tip and extends along the shaft.

[0297] According to this configuration, the oxygen sensor body is integrally provided at the tip of the transmission part, so that the oxygen sensor can be easily assembled to the shaft.

[0298] In the above oxygen measuring device, the oxygen sensor main body may be located inside the urinary drainage port.

[0299] With this configuration, the oxygen sensor main body can be brought into contact with urine flowing in from the urine drainage port.

[0300] In the above-described oxygen measuring device, the shaft may be formed with a sensor lumen in which the transmission section is disposed, the urinary tract may have a urinary catheter lumen extending in the axial direction of the shaft, and a lateral urinary catheter lumen communicating with the urinary catheter lumen and provided toward the tip of the sensor lumen, and the oxygen sensor may extend into the lateral urinary catheter lumen so that the oxygen sensor main body is located within the urinary catheter lumen.

[0301] With this configuration, since the transmitting part is disposed in the sensor lumen, the flow of urine in the urinary catheter lumen is prevented from being obstructed by the transmitting part, thereby allowing the urine to flow smoothly through the urinary tract. Also, the oxygen sensor body can be brought into efficient contact with the urine in the urinary catheter lumen.

[0302] In the above-described oxygen measuring device, the oxygen sensor body is located at the base end side of the urinary drainage opening by folding back the transmission section from the lateral urinary drainage lumen toward the base end side toward the urinary drainage lumen, a tip opening of a lumen that constitutes the urinary tract is formed at the tip of the shaft, and the urethral catheter has an obstructing section fitted into the tip opening, and the obstructing section may hold the folded back portion of the transmission section.

[0303] This configuration allows the oxygen sensor body to efficiently come into contact with urine introduced into the urinary catheter lumen from the urinary catheter port. In addition, the occluding part can hold the transmitting part, preventing the oxygen sensor body from shifting position within the urinary catheter lumen.

[0304] The above-mentioned oxygen measuring device may include a fixing portion that fixes the oxygen sensor to the shaft, and the fixing portion may hold the oxygen sensor body within the urinary tract so that the oxygen sensor body comes into contact with the urine flowing through the urinary tract.

[0305] According to this configuration, the fixing portion can suppress displacement of the oxygen sensor body relative to the shaft, thereby improving the measurement accuracy of the oxygen sensor.

[0306] In the oxygen measuring device, the fixing part may be located inside or outside the urinary tract.

[0307] With this configuration, when the fixing part is located inside the urinary tract, the oxygen sensor main body can be easily held inside the urinary tract, and when the fixing part is located outside the urinary tract, the fixing part can be prevented from obstructing the flow of urine inside the urinary tract.

[0308] In the oxygen measuring device, the fixing part may be located at a distal end side within the urinary tract.

[0309] According to this configuration, the fixing portion can suppress displacement of the oxygen sensor body relative to the shaft, thereby improving the measurement accuracy of the oxygen sensor.

[0310] In the oxygen measuring device described above, the fixing portion may have a support portion provided on the shaft, and an engaging portion that engages with the support portion in a state where the fixing portion is fixed to the oxygen sensor.

[0311] According to this configuration, the oxygen sensor can be fixed to the shaft with a simple structure.

[0312] In the above-mentioned oxygen measuring device, the oxygen sensor may have a transmission part electrically and / or optically connected to the oxygen sensor body, the shaft may be provided with a sensor lumen in which the transmission part is arranged, and the fixing part may fix the transmission part to the inner surface constituting the sensor lumen.

[0313] With this configuration, it is possible to prevent the transmission section from interfering with the flow of urine in the urinary tract, and therefore it is possible to allow urine in the bladder to flow smoothly through the urinary tract.

[0314] In the above oxygen measuring device, a recess may be provided on a surface of the fixing part that is exposed to the urinary tract, and the oxygen sensor main body may be located within the recess.

[0315] With this configuration, urine flowing through the urinary tract can be brought into more reliable contact with the oxygen sensor main body.

[0316] In the above-mentioned oxygen measuring device, the fixing portion may be in liquid-tight contact with the inner surface constituting the sensor lumen so as to prevent the flow of urine from the urinary tract toward the base end side of the fixing portion in the sensor lumen.

[0317] This configuration allows urine to flow efficiently through the urinary tract.

[0318] In the above-mentioned oxygen measuring device, the oxygen sensor may have a transmission part electrically and / or optically connected to the oxygen sensor body, and the fixing part may fix the transmission part to the inner surface that constitutes the urinary tract.

[0319] According to this configuration, the oxygen sensor can be fixed to the shaft with a simple structure.

[0320] In the oxygen measuring device, the fixing portion may be spaced apart from an inner surface of the urinary tract that faces the fixing portion.

[0321] This configuration allows the urine to flow smoothly through the urinary tract.

[0322] In the oxygen measuring device, the fixing part may cover the transmitting part within the urinary tract.

[0323] This configuration allows urine to flow more smoothly through the urinary tract.

[0324] In the above oxygen measuring device, the shaft may be provided with a sensor lumen in which the oxygen sensor is disposed.

[0325] With this configuration, it is possible to prevent the oxygen sensor from interfering with the flow of urine in the urinary tract, thereby allowing the urine to flow smoothly in the urinary tract.

[0326] In the above-mentioned oxygen measurement device, the oxygen sensor may have a transmission part electrically connected to the oxygen sensor body, the oxygen sensor body may be located within the urinary tract, and the transmission part may be located within the sensor lumen.

[0327] With this configuration, urine flowing through the urinary tract can be reliably brought into contact with the oxygen sensor body, and the transmission section can be prevented from interfering with the flow of urine through the urinary tract.

[0328] In the above-mentioned oxygen measuring device, a fixing portion is provided to fix the transmission portion to the inner surface constituting the sensor lumen, the sensor lumen extends along the axial direction of the shaft, and the fixing portion is arranged so that the tip end of the sensor lumen is sealed when the oxygen sensor is inserted through the tip end.

[0329] This configuration can prevent the oxygen sensor body from shifting relative to the shaft. It can also prevent the fixing part from obstructing the flow of urine through the urinary tract. Furthermore, since the area around the oxygen sensor body can be filled with urine, the urine flowing through the urinary tract can be more reliably brought into contact with the oxygen sensor body.

[0330] In the oxygen measuring device, the sensor lumen may be shorter than the urinary tract in the axial direction of the shaft.

[0331] In the above oxygen measuring device, the sensor lumen may have an opening for positioning the oxygen sensor body within the urinary tract.

[0332] With this configuration, the oxygen sensor body can be disposed within the urinary tract while the transmission section is disposed in the sensor lumen.

[0333] In the oxygen measuring device, the fixing part may be provided with an insertion hole through which the oxygen sensor is inserted, and a tip of the insertion hole may be located near the urine drainage port.

[0334] With this configuration, the oxygen sensor main body can be easily positioned near the urinary drainage port.

[0335] In the oxygen measuring device, the urinary passage may have a urinary catheter lumen arranged in parallel with the sensor lumen, and the insertion hole may be located on the urinary catheter lumen side.

[0336] In the oxygen measuring device, the insertion hole may be provided on an outer surface of the fixing part on the side of the urinary catheter lumen.

[0337] With this configuration, the oxygen sensor main body can be positioned on the urinary catheter lumen side.

[0338] In the oxygen measuring device, the opening may have an opening area smaller than an opening area of ​​the urine drainage port.

[0339] In the oxygen measuring device, the opening may be located closer to the base end than the urinary drainage port.

[0340] In the above oxygen measuring device, the urinary tract extends along the axial direction of the shaft and has a first urinary tract section in which the urinary drainage port is located, and a second urinary tract section extending from the first urinary tract section toward the base end, and the flow path cross-sectional area of ​​the first urinary tract section may be larger than the flow path cross-sectional area of ​​the second urinary tract section.

[0341] With this configuration, urine in the bladder can be efficiently made to flow from the urinary drainage port into the first urinary tract portion.

[0342] In the above oxygen measuring device, the oxygen sensor main body may be located in the first urinary tract portion.

[0343] With this configuration, urine that has flowed from the bladder into the first urinary tract portion via the urinary drainage port can be reliably brought into contact with the oxygen sensor main body.

[0344] In the above oxygen measuring device, the oxygen sensor main body may be located in the second urinary tract portion.

[0345] With this configuration, even when the amount of urine excreted is relatively small, urine flowing through the second urinary tract portion can be reliably brought into contact with the oxygen sensor main body.

[0346] In the oxygen measuring device, the cross-sectional flow path area of ​​the second urinary tract portion at the distal end of the shaft may be smaller than the cross-sectional flow path area of ​​the second urinary tract portion at the proximal end of the shaft.

[0347] With this configuration, urine in the second urinary tract portion can flow smoothly toward the base end of the shaft.

[0348] In the oxygen measuring device, the shaft may be provided with a sensor lumen that is provided in parallel to the second urinary tract portion and in which the oxygen sensor is disposed.

[0349] With this configuration, it is possible to prevent the oxygen sensor from interfering with the flow of urine in the urinary tract, and therefore it is possible to allow urine in the bladder to flow smoothly through the urinary tract.

[0350] In the above oxygen measuring device, the oxygen sensor main body may be adjacent to the distal end side or proximal end side of the urinary drainage opening in the urinary tract.

[0351] With this configuration, urine flowing into the urinary tract from the urine drainage port can be reliably brought into contact with the oxygen sensor body, and even if the shaft buckles at the position of the urine drainage port, damage to the oxygen sensor body can be prevented.

[0352] In the above oxygen measuring device, the oxygen sensor main body may be located in a direction perpendicular to the axial direction of the shaft relative to the urine drainage port.

[0353] With this configuration, urine that has flowed into the urinary tract from the urine drainage port can be brought into efficient contact with the oxygen sensor main body.

[0354] In the above-mentioned oxygen measuring device, the urinary catheter may have a balloon provided at the tip of the shaft that can be expanded and contracted with an expansion fluid, and the oxygen sensor main body may be located further distal than the balloon in the axial direction of the shaft.

[0355] With this configuration, the oxygen sensor body can be positioned inside the bladder, making it possible to detect oxygen in urine in a relatively stable environment (an environment with relatively little temperature change, etc.). In addition, the shaft can be held against the bladder by the balloon, further preventing the oxygen sensor body from being displaced inside the bladder.

[0356] In the above-mentioned oxygen measuring device, the shaft may be provided with a sensor lumen extending along the axial direction of the shaft and in which the oxygen sensor is disposed, and the urine drainage port may be positioned offset from the axis of the shaft to the side where the sensor lumen is located.

[0357] With this configuration, the oxygen sensor main body can be easily placed adjacent to the urinary drainage opening.

[0358] In the oxygen measuring device, the center of the shaft in the axial direction at the urine drainage port may be located at a portion of the shaft that is located closer to the tip than the sensor lumen.

[0359] With this configuration, urine that has flowed from the bladder into the urinary tract via the urine drainage port can be reliably brought into contact with the oxygen sensor main body.

Claims

1. a urinary catheter including a flexible hollow shaft; an oxygen sensor having an oxygen sensor body capable of detecting oxygen in urine; The shaft has a urinary drainage port through which the urine in the bladder flows; a urinary tract that communicates with the urinary drainage port and through which the urine flows; a side lumen extending along the axial direction of the shaft; An opening communicating with the urinary tract is provided at the tip of the side lumen, the oxygen sensor is disposed in the side lumen so that the oxygen sensor body comes into contact with the urine flowing in from the opening of the side lumen or the urinary drainage port; The oxygen sensor a transmission portion disposed within the side lumen; the oxygen sensor body fixed to the tip of the transmission part; and The urinary catheter has a balloon provided at the distal end of the shaft and capable of expanding and contracting with an expansion fluid, The oxygen sensor body is located distal to the balloon in the axial direction of the shaft and in the vicinity of the urinary drainage port.

2. An oxygen measuring device according to claim 1, a fixing portion that fixes the oxygen sensor to the shaft, The fixed portion is provided at a portion other than the tip of the oxygen sensor.

3. The oxygen measuring device according to claim 2, An oxygen measuring device, wherein the fixing portion is provided on the transmission portion without being provided on the oxygen sensor main body.

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