Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters

Definitions

• the present invention relates to a catheter incorporating a sensor having a sensor body attached to one end of a transmission cable.
• Acute kidney injury which occurs in 30-50% of patients admitted to intensive care units, has a negative impact on the prognosis of patients even if it is mild, and the mortality rate when blood purification is required is as high as 60%.
• the progression to chronic renal failure is also a problem.
• One of the causes of AKI is hypoxia in the renal medulla, and it is thought that the renal medulla oxygen pressure can be estimated by measuring the urinary oxygen pressure in the bladder.
• a catheter In order to measure the oxygen pressure in urine in the bladder, a catheter has been proposed that measures the oxygen pressure in the bladder or bladder wall by protruding an oxygen pressure measurement sensor from the side hole of the urethral catheter (see, for example, Patent Document 1).
• a catheter in which an oxygen pressure measurement sensor with a sensor body attached to one end of a transmission cable is inserted from the base end into the urination lumen of the catheter, and the sensor body is placed in the urination lumen at the tip of the catheter.
• the catheter body can be left in the body and used continuously even after the surgery is completed, but the oxygen pressure measurement sensor inserted into the catheter body is no longer needed after the operation.
• the transmission cable were to extend from the base end of the catheter to the outside, it could get caught on an external object or person, and in the case of a balloon catheter in particular, there was a risk that the catheter could be forcibly pulled out along with the transmission cable while the balloon was inflated.
• the present invention aims to solve the problems associated with the conventional technology described above and provide a catheter that can properly secure a sensor without the need for adhesives.
• the present invention is characterized in that the catheter incorporates a sensor having a sensor body attached to one end of a transmission cable, the catheter being a tube having an inner lumen that communicates with an opening formed at the tip, the tube having a pair of holding parts that hold the sensor by sandwiching it in a direction along the inner circumference of the inner lumen.
• the device may further include a guide portion that guides the sensor in a direction away from the inner circumferential surface of the lumen.
• the guide portion may have an abutment end that abuts against the sensor formed in a wedge shape.
• the guide portion may be attached to the holding portion.
• the guide portion may be defined by the holding portion along the tube and formed to block the cable holding lumen near the tip.
• the device may further include a balloon provided on the outer periphery of the tube, and the abutment end of the guide portion that abuts against the sensor may be located inside the balloon.
• the device may further include a balloon provided on the outer periphery of the tube, and the holding portion may be located inside the balloon.
• the tube may contract when the balloon expands, narrowing the gap between one of the holding portions and the other holding portion.
• the present invention provides a catheter that can properly secure a sensor without the need for adhesives.
• FIG. 1 is a side view of a balloon catheter according to an embodiment of the present invention.
• FIG. 2 shows a cross-sectional view of a balloon catheter with the balloon inflated.
• a cross-sectional view of the proximal end of a balloon catheter is shown.
• 1 shows a longitudinal cross-section of a tube.
• FIG. 1 shows a side view of a balloon catheter
• FIG. 2 shows a cross-sectional view of the balloon catheter with the balloon inflated
• FIG. 3 shows a cross-sectional view of the base end of the balloon catheter
• FIG. 4 shows a longitudinal cross-sectional view of the tube
• FIG. 5 shows a perspective view of the guide portion.
• the balloon catheter 100 comprises a catheter body 10, a sensor 30, and a fixing part 40.
• This balloon catheter 100 is an integrated product in which the fixing part 40 is attached to the catheter body 10, and the sensor 30 is fixed to the catheter body 10 via the fixing part 40.
• the catheter body 10 is composed of a tip portion 11, a tube 12, a balloon 13, and a branch portion 14.
• the tip portion 11 and the balloon 13 are connected to the tube 12 at the tip side of the catheter body 10, while the branch portion 14 is connected to the tube 12 at the base end side of the catheter body 10 to form an integrated unit.
• the tip 11, tube 12, balloon 13, and branch 14 are made of silicone rubber, but may also be made of latex, natural rubber, isoprene rubber, thermoplastic resins such as PVC and urethane rubber, fluororubber and fluororesin, etc.
• the tube 12 penetrates the balloon 13, and the balloon 13 is attached to the outer periphery near the tip by gluing. That is, the balloon 13 is formed so as to surround the entire circumference of the tube 12.
• the tube 12 also has a cylindrical tip 11 attached to the end face of the tip by gluing.
• the tube 12 has a urination lumen (inner cavity) 15 for flowing urine formed along the extension direction of the tube 12.
• the urination lumen 15 communicates with the outside through a tip hole (opening) 16 and a side hole (opening) 17 formed in the tip 11, and urine flowing in from the tip hole 16 and the side hole 17 flows through the urination lumen 15 to the branching part 14 on the base end side.
• the tube 12 has a thick-walled portion, and a balloon lumen 18 for inflating the balloon 13 is formed in this thick-walled portion along the extension direction of the tube 12.
• the balloon lumen 18 is fluidly connected to the inside of the balloon 13 near the tip, and the balloon 13 is inflated by filling it with sterilized water supplied from the branching portion 14 on the base end side.
• the urination lumen 15 is formed to have a substantially circular flow passage cross section, and the balloon lumen 18 is formed to have a smaller circular flow passage cross section than the urination lumen 15.
• the balloon 13 is formed so that it has a cylindrical shape when not inflated.
• the non-inflatable portions of the balloon 13 on the distal and proximal sides are formed in a tapered shape, so that the outer diameter smoothly decreases toward the distal and proximal ends.
• sterile water is supplied from the branching portion 14 via the balloon lumen 18, the balloon 13 expands into a spherical shape centered on the tube 12 between the distal expansion end 13A and the proximal expansion end 13B. This allows the balloon catheter 100 to be fixed in place by the balloon 13 getting caught in the patient's bladder and not coming out.
• the branching section 14 is connected to the tube 12 at its tip end, while its base end is divided into three parts: a balloon injection port 19, a transmission cable insertion port 20, and a urination port 21.
• the balloon injection port 19 is fluidly connected to the balloon lumen 18 and can be connected to a reservoir (not shown) for injecting sterile water into the balloon lumen 18.
• the transmission cable insertion port 20 extends linearly into the urination lumen 15, and the sensor 30 inserted straight into the transmission cable insertion port 20 is inserted straight into the urination lumen.
• the urination outlet 21 extends obliquely relative to the urination lumen 15 and is connectable to a urination tube (not shown) and is connected to a urine bag or the like via the urination tube.
• the sensor 30 inserted into the transmission cable insertion port 20 comprises a sensor body 31 and a transmission cable 32, as shown in FIG. 2.
• the sensor 30 according to this embodiment is an oxygen partial pressure measurement sensor, the sensor body 31 is an excitation light irradiator, and the transmission cable 32 is an optical fiber, which is made of a material that is harder and more elastic than the tube 12.
• a phosphor is applied inside the urination lumen 15 of the tube 12, and the light sent from the transmission cable 32 is irradiated from the sensor body 31 to the phosphor.
• the fixing part 40 is attached to the transmission cable insertion port 20, and the sensor 30 is fixed to the tube 12 via the fixing part 40 that fixes the transmission cable 32.
• the fixing part 40 comprises a fixing part main body 41, a fixing part cap 42, and a fastening part 43.
• the fastening part 43 has an annular shape with a through hole 43A formed in the center through which the transmission cable 32 can pass.
• the fastening part 43 is sandwiched between the fixing part main body 41 and the fixing part cap 42 which is screwed into the fixing part main body 41.
• the fixing part cap 42 is screwed into the fixing part main body 41, the fastening part 43 is crushed and the diameter of the through hole 43A becomes smaller. This allows the fastening part 43 to fasten the transmission cable 32 and fix the transmission cable 32 in place.
• the tube 12 has a pair of cable holders 22, 23 formed in the urination lumen 15 for holding the transmission cable 32.
• the cable holders 22, 23 are formed integrally with the tube 12 in a plate shape and extend from the distal end to the proximal end of the tube 12 along the urination lumen 15.
• the urination lumen 15 is divided by the cable holding parts 22, 23 into a first area A1 with a large flow area and a second area A2 with a small flow area, and the transmission cable 32 is accommodated and held within the second area A2, which is the cable holding lumen.
• the pair of cable holding parts 22, 23 protrude from the inner circumferential surface of the tube 12 so as to face each other.
• One cable holding part 22 and the other cable holding part 23 protrude from the inner circumferential surface of the tube 12 by the same distance.
• the distance between the tip 22A of one cable holding part 22 and the tip 23A of the other cable holding part 23 is smaller than the diameter of the transmission cable 32. This holds the transmission cable 32 so that it cannot move freely to the opposite side of the pair of cable holding parts 22, 23.
• the pair of cable holding parts 22, 23 are integrally formed from the same soft material as the tube 12.
• a guide portion 24 is incorporated into the second region A2 of the tube 12. As shown in FIG. 5, this guide portion 24 is formed to have a crescent-shaped cross section and extends like a column, and has an arcuate surface 24A and a flat surface 24B. One end of the guide portion 24 is formed with an abutment end 24C that abuts against the sensor 30. This abutment end 24C is a wedge-shaped portion that has a slope, and the guide portion 24 guides the sensor 30 by abutting against the transmission cable 32 with the slope of the abutment end 24C.
• the guide portion 24 is incorporated into the second region A2 of the tube 12, with the arcuate surface 24A abutting against the inner circumferential surface of the tube 12 and the flat surface 24B abutting against the cable holding portions 22, 23. As a result, the guide portion 24 blocks the second region A2, which is the cable holding lumen, near the tip of the catheter body 10.
• the guide portion 24 is inserted from the tip side of the catheter body 10 toward the base end into the tube 12 and is adhered to the inside of the tube 12, with the abutment end 24 that comes into contact with the sensor 30 located inside the balloon 13.
• the guide portion 24 is adapted to guide the sensor 30 by abutting the transmission cable 32 of the sensor 30 from the tip side with the abutment end 24C within the second area A2 of the urination lumen 15. In this way, the guide portion 24 guides the sensor 30 toward the vicinity of the center of the first area A1 of the urination lumen 15.
• the guide portion 24 is formed from the same soft material as the tube 12. This allows the guide portion 24 to contract together with the tube 12 when the balloon 13 expands and the internal pressure of the balloon 13 is applied to the outer periphery of the tube 12. At this time, the contracted tube 12 narrows the gap between the cable holding portion tip 22A of one cable holding portion 22 and the cable holding portion tip 23A of the other cable holding portion 23, and firmly holds the transmission cable 32 sandwiched between them.
• the catheter body 10 holds the transmission cable 32 of the sensor 30 between a pair of cable holders 22, 23 in a first direction D1 (see FIG. 4) along the inner circumference of the urination lumen 15, and guides the sensor 30 in a second direction D2 (see FIG. 4) away from the inner surface of the urination lumen 15 with the guide portion 24.
• the sensor 30 is then moved through the second area A2 until the sensor body 31 is positioned within the balloon 13.
• the second area A2 has a flow passage cross-section that is sufficiently large for the sensor body 31 and transmission cable 32 of the sensor 30, so that the sensor 30 can easily pass through the second area A2 of the tube 12.
• the sensor 30 passing through the second area A2 is guided toward the first area A1 by the sensor body 31 hitting the guide portion 24 inside the balloon 13, and the sensor body 31 passes between the pair of cable holding portions 22, 23 and protrudes from the second area A2 into the first area A1.
• the transmission cable 32 is fixed in the gap between one cable holding portion 22 and the other cable holding portion 23 near the sensor body 31, and the portion of the transmission cable 32 on the base end side from the pinched portion is held in the second area A2.
• the transmission cable 32 protruding from the fixed part 40 is simply pulled by hand, and the transmission cable 32 and the sensor body 31 that were sandwiched between the pair of cable holders 22, 23 are pulled into the second area A2 of the urination lumen 15 through the gap between the pair of cable holders 22, 23.
• the transmission cable 32 protruding from the fixed part 40 can be continued to be pulled, causing the sensor 30 to move through the second area A2 to the fixed part 40 and then be pulled out from the fixed part 40.
• the balloon catheter 100 is a tube 12 having a urination lumen 15 formed therein that communicates with a tip hole 16 and a side hole 17 formed at the tip, and the tube 12 has a pair of cable holders 22, 23 that sandwich and hold the transmission cable 32 of the sensor 30 in a direction along the inner circumference of the urination lumen 15. This allows the sensor 30 to be held in a sandwiched state with the sensor body 31 facing the center of the urination lumen 15, so that the sensor 30 can be appropriately fixed without the need for adhesives.
• the present invention has been described above based on the embodiments, but the present invention is not limited to this.
• the transmission cable 32 is held using the cable holding parts 22 and 23, but the present invention is not limited to this.
• the holding part may clamp and hold the sensor main body 31.
• a sensor 30 consisting of an irradiation unit and an optical fiber is used, but this is not limited to this. Any other type of sensor may be used as long as it is capable of measuring oxygen partial pressure.

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Citations (4)

• 2024
  • 2024-11-20 WO PCT/JP2024/041188 patent/WO2025121145A1/ja active Pending
  • 2024-11-20 JP JP2025561796A patent/JPWO2025121145A1/ja active Pending

Patent Citations (4)

Non-Patent Citations (1)

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