WO2021059992A1 - Système de cathéter - Google Patents

Système de cathéter Download PDF

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Publication number
WO2021059992A1
WO2021059992A1 PCT/JP2020/034243 JP2020034243W WO2021059992A1 WO 2021059992 A1 WO2021059992 A1 WO 2021059992A1 JP 2020034243 W JP2020034243 W JP 2020034243W WO 2021059992 A1 WO2021059992 A1 WO 2021059992A1
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WO
WIPO (PCT)
Prior art keywords
fluid
balloon
tube
lumen
supply device
Prior art date
Application number
PCT/JP2020/034243
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English (en)
Japanese (ja)
Inventor
早川浩一
原田尚実
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to CN202080052568.1A priority Critical patent/CN114144220B/zh
Priority to JP2021548783A priority patent/JPWO2021059992A1/ja
Publication of WO2021059992A1 publication Critical patent/WO2021059992A1/fr

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    • 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
    • A61M25/1018—Balloon inflating or inflation-control devices
    • 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
    • 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
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies

Definitions

  • the present invention relates to a catheter system.
  • Japanese Patent No. 3921108 discloses a balloon catheter for treating a lesion (stenosis or occlusion) of the fallopian tube.
  • This balloon catheter includes a flexible outer tube, an inner tube arranged in the inner tube of the outer tube so as to be movable in the axial direction with respect to the outer tube, and the tip and inner tube of the outer tube. It is provided with an annular balloon that connects the tips to each other.
  • an outer lumen for supplying the balloon operating fluid to the outer space formed between the balloon and the outer pipe is provided.
  • the outer lumen communicates with a first introduction port formed in an outer tube hub provided at the base end of the outer tube.
  • the lumen of the inner tube is provided with an inner lumen for supplying the perfusate inside the balloon.
  • the inner lumen communicates with a second inlet port formed in an inner tube hub provided at the base end of the inner tube.
  • a syringe for supplying the balloon operating fluid to the first introduction port and a perfusion pump for supplying the perfusate to the second introduction port. And prepare. Then, a fallopian tube (medical wire) is inserted inside the balloon through the lumen of the inner tube.
  • a fallopian tube medical wire
  • a balloon derivation step is performed in which the balloon is led out to the tip side of the outer tube (the balloon is inserted into the oviduct).
  • a pressurizing step of inflating the balloon inward in the radial direction to bring it into close contact with the fallopian tube mirror a forward step of advancing the balloon and the fallopian tube mirror, and releasing the pressurization of the balloon on the fallopian tube mirror and balloon
  • a decompression step of supplying the perfusate to the inside of the fallopian tube and a retreat step of retracting the fallopian tube mirror are performed.
  • an assistant other than the operator who operates the balloon catheter operates the syringe. Therefore, the balloon derivation process may not be performed efficiently.
  • the present invention has been made in consideration of such a problem, and an object of the present invention is to provide a catheter system capable of efficiently performing a balloon derivation step with a simple configuration.
  • One aspect of the present invention is an outer tube having flexibility, an inner tube arranged in the lumen of the outer tube so as to be movable in the axial direction with respect to the outer tube, and a tip of the outer tube.
  • An annular balloon that connects the portion and the tip of the inner tube to each other and swells inward in the radial direction of the outer tube is provided, and a medical wire is inserted into the inside of the balloon through the lumen of the inner tube.
  • a possible balloon catheter and a fluid supply device for supplying a fluid for elastically deforming the balloon in the radial direction are provided, and a bag-shaped outer space having a closed tip is provided between the balloon and the outer tube.
  • an outer lumen for supplying the fluid to the outer space is provided between the inner pipe and the outer pipe, and the inner pipe and the outer pipe are inserted in a state where the medical wire is inserted.
  • a catheter system in which an inner lumen for supplying the fluid is provided inside the balloon between the medical wire rod, and the fluid supply device is a supply device main body for sending the fluid and the supply device.
  • the supply device main body has a low pressure mode in which the pressure of the fluid is set to a first pressure, and the supply flow path for supplying the fluid guided from the main body to the outer lumen and the inner lumen.
  • the catheter system includes a mode switching unit that switches the pressure of the fluid to a high pressure mode in which the pressure of the fluid is set to a second pressure higher than the first pressure.
  • the fluid sent from the supply device main body to the supply flow path is supplied to the outer space of the balloon via the outer lumen and to the inside of the balloon via the inner lumen.
  • the mode switching unit selects the high pressure mode
  • the pressure of the fluid supplied to the bag-shaped outer space with the tip closed becomes the second pressure.
  • the fluid supplied to the inside of the annular balloon flows out from the tip opening of the balloon.
  • pressure drop occurs as the fluid flows through the inner lumen. Therefore, the pressure of the fluid supplied to the inside of the balloon becomes lower than the second pressure. Therefore, the balloon can be inflated inward in the radial direction by the fluid supplied to the outer space and brought into close contact with the outer peripheral surface of the medical wire. Therefore, the balloon can be efficiently advanced to the tip end side of the outer tube together with the medical wire.
  • the mode switching unit selects the low pressure mode
  • the fluid supplied to the outer space drops from the second pressure to the first pressure, so that the fluid easily flows between the balloon and the medical wire. Therefore, the medical wire can be efficiently retracted with respect to the balloon.
  • the mode switching unit can change the pressure between the fluid supplied to the inside of the balloon and the fluid supplied to the outer space of the balloon. Therefore, the balloon derivation step can be efficiently performed with a simple configuration.
  • FIG. 1 is a first explanatory view of salpingoscopic tuboplasty using the catheter system of FIG.
  • FIG. 2 is a second explanatory view of salpingoscopic tuboplasty using the catheter system of FIG.
  • FIG. 3 is a third explanatory view of salpingoscopic tuboplasty using the catheter system of FIG. FIG.
  • FIG. 4 is a fourth explanatory view of salpingoscopic tuboplasty using the catheter system of FIG.
  • FIG. 5 is a fifth explanatory view of salpingoscopic tuboplasty using the catheter system of FIG.
  • FIG. 6 is a sixth explanatory view of salpingoscopic tuboplasty using the catheter system of FIG. It is a schematic block diagram of the catheter system which concerns on 2nd Embodiment of this invention. It is a partially omitted vertical sectional view of the balloon catheter of FIG.
  • the catheter system 10A according to the first embodiment of the present invention is used, for example, in tuboplasty for treating a lesion (stenosis, occlusion, etc.) of the fallopian tube.
  • the catheter system 10A may be for treating lesions in biological organs such as blood vessels, bile ducts, trachea, esophagus, urethra, and other organs other than the oviduct.
  • the catheter system 10A includes a balloon catheter 12, a fluid supply device 14 for supplying fluid to the balloon catheter 12, and a salpingoscope 15 (medical wire rod).
  • the balloon catheter 12 is provided at the outer catheter 16, the slider 18 provided on the outer catheter 16, the inner catheter 20 inserted into the outer catheter 16, and the tip of the inner catheter 20.
  • the balloon 22 is provided.
  • the outer catheter 16 has a long flexible outer tube 24, an outer tube hub 26 provided at the base end of the outer tube 24, and a fixing screw 28 provided on the outer tube hub 26.
  • the total length of the outer tube 24 is preferably set to 100 mm or more and 1500 mm or less, and more preferably 200 mm or more and 1000 mm or less.
  • the outer tube 24 includes an outer tube main body 30 and a tip tip 32 provided at the tip of the outer tube main body 30.
  • the constituent materials of the outer tube main body 30 and the tip tip 32 include polyolefin (for example, polyethylene, polypropylene, polybutene, etc.), olefin elastomer, polyester (for example, polyethylene terephthalate, etc.), polyester elastomer, and soft polyvinyl chloride.
  • Examples thereof include flexible polymer materials such as vinyl, polyurethane, urethane-based elastomers, polyamides, amide-based elastomers, polytetrafluoroethylene, fluororesin elastomers, polyimides, ethylene-vinyl acetate copolymers, and silicone rubbers.
  • flexible polymer materials such as vinyl, polyurethane, urethane-based elastomers, polyamides, amide-based elastomers, polytetrafluoroethylene, fluororesin elastomers, polyimides, ethylene-vinyl acetate copolymers, and silicone rubbers.
  • the outer tube body 30 is a tube body having a first lumen 30a penetrating from the tip end to the base end.
  • the outer tube main body 30 has a substantially constant inner diameter and a substantially constant outer diameter from the tip end to the base end.
  • the outer diameter of the outer tube 24 is preferably set to 1.8 mm or more and 10 mm or less, and more preferably 2.3 mm or more and 8 mm or less.
  • the inner diameter of the outer tube 24 is preferably set to 1.2 mm or more and 7.8 mm or less, and more preferably 1.5 mm or more and 5.8 mm or less.
  • the tip end side of the outer pipe body 30 is shaped so as to be curved in an arc shape.
  • the outer surface of the tip tip 32 is curved to prevent damage to the balloon catheter 12 and living tissue.
  • the tip tip 32 is formed with a balloon lead-out hole 32a for leading the balloon 22 toward the tip of the tip tip 32.
  • the outer tube hub 26 is made of hard resin or metal (stainless steel, titanium, titanium alloy, etc.).
  • hard resin include polycarbonate, acrylic resin, polyester, polyolefin, styrene resin, polyamide, polysulfone, polyarylate, polyetherimide and the like.
  • the outer tube hub 26 is formed in a hollow shape with a size that is easy to operate manually.
  • the outer tube hub 26 has a first space 34 communicating with the first lumen 30a of the outer tube 24, and a first insertion hole 36 located on the proximal end side of the first space 34 through which the inner catheter 20 is inserted.
  • An introduction port 38 (first introduction port) communicating with the first space 34 is formed.
  • the introduction port 38 introduces the fluid supplied from the fluid supply device 14 into the first space 34.
  • the tubular port forming portion 40 forming the introduction port 38 is formed so that the first connector 82 (see FIG. 1) of the fluid supply device 14 can be connected to the tubular port forming portion 40.
  • the outer pipe hub 26 is provided with a first seal member 42 for preventing the fluid in the first space 34 from leaking to the outside through the first insertion hole 36.
  • the fixing screw 28 fixes the inner catheter 20 to the outer tube hub 26 by screwing it into the screw hole 44 formed at the base end portion of the outer tube hub 26.
  • Examples of the constituent material of the fixing screw 28 are the same as those of the outer tube hub 26.
  • the slider 18 is provided on the outer peripheral surface of the outer pipe 24 in a state where it can be moved (sliding) in the axial direction of the outer pipe 24.
  • the total length of the slider 18 is shorter than the total length of the outer pipe 24.
  • the slider 18 has a long tubular slider main body 46 and a slider hub 48 provided at a base end portion of the slider main body 46.
  • Each of the slider body 46 and the slider hub 48 is made of the same material as the outer tube hub 26 described above.
  • the slider hub 48 is formed in a ring shape in a size that is easy to operate manually.
  • the tip side of the outer pipe 24 is from the slider 18. Is exposed to the tip side and curved in an arc shape.
  • the tip side of the outer tube 24 has the shape of the slider body 46. It extends linearly along it (see FIG. 6).
  • the inner catheter 20 includes a long inner tube 50 and an inner tube hub 52 provided at the proximal end of the inner tube 50.
  • the total length of the inner pipe 50 is preferably set to 100 mm or more and 1500 mm or less, and more preferably 200 mm or more and 1000 mm or less.
  • the inner tube 50 is made of a relatively hard resin (for example, fluororesin, polycarbonate, polyimide, PEEK resin, etc.) or a metal (for example, stainless steel, titanium, titanium alloy, etc.).
  • the inner tube 50 is a tube body having a second lumen 50a penetrating from the tip end to the base end.
  • the inner tube 50 has a substantially constant inner diameter and a substantially constant outer diameter from the tip end to the base end.
  • the outer diameter of the inner pipe 50 is preferably set to 0.8 mm or more and 6.8 mm or less, and more preferably 1 mm or more and 5 mm or less.
  • the wall thickness of the inner tube 50 is preferably set to 0.025 mm or more and 1 mm or less, and more preferably 0.03 mm or more and 0.5 mm or less.
  • the inner pipe 50 is arranged in the first lumen 30a of the outer pipe 24 while inserting the first space 34 and the first insertion hole 36 of the outer pipe hub 26.
  • the tip of the inner tube 50 is located in the proximal direction with respect to the tip of the outer tube 24.
  • An outer lumen 54 through which a fluid for inflating the balloon 22 in the radial direction of the outer tube 24 (a fluid for operating the balloon) flows is provided between the inner tube 50 and the outer tube 24.
  • a fallopian tube mirror 15 as a medical wire is inserted into the second lumen 50a of the inner tube 50.
  • the fallopian tube mirror 15 is an endoscope for photographing the inside of the fallopian tube.
  • the inner lumen 56 (for perfusion) through which a fluid (perfusion fluid) flows between the inner tube 50 and the fallopian tube mirror 15 Lumen) is formed.
  • the flow path cross-sectional area of the inner lumen 56 is smaller than the flow path cross-sectional area of the outer lumen 54.
  • the inner tube hub 52 is made of the same material as the outer tube hub 26.
  • the inner tube hub 52 is formed in a hollow shape.
  • the inner tube hub 52 has a second space 58 that communicates with the second lumen 50a of the inner tube 50, and a second insertion hole 60 that is located on the proximal end side of the second space 58 and through which the oviduct mirror 15 is inserted.
  • An introduction port 62 (second introduction port) communicating with the second space 58 is formed.
  • the introduction port 62 introduces the fluid supplied from the fluid supply device 14 into the second space 58.
  • the tubular port forming portion 64 forming the introduction port 62 is formed so that the second connector 86 (see FIG. 1) of the fluid supply device 14 can be connected to the tubular port forming portion 64.
  • the inner pipe hub 52 is provided with a second seal member 66 that prevents the fluid in the second space 58 from leaking to the outside through the second insertion hole 60.
  • the balloon 22 is an annular member that connects the tip of the outer tube 24 and the tip of the inner tube 50 to each other.
  • the balloon 22 inflates inward in the radial direction of the outer tube 24.
  • the balloon 22 is formed so as to be elastically deformable in the radial direction.
  • the constituent materials of the balloon 22 include natural rubber, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, soft polyvinyl chloride, polyurethane, polyurethane elastomer, polyisoprene, polyamide, and polyamide elastomer. Examples thereof include polyimide, polytetrafluoroethylene, and silicone.
  • the balloon 22 is preferably composed of a polyamide elastomer, a urethane-based elastomer, or a polyester elastomer.
  • One end of the balloon 22 is adhered or fused to the tip of the outer tube 24.
  • one end of the balloon 22 is adhered or fused to the vicinity of the base end side of the balloon lead-out hole 32a in the outer tube 24.
  • the other end of the balloon 22 is adhered or fused and fixed to the tip of the outer surface of the inner tube 50.
  • the other end of the balloon 22 may be adhered or fused to the tip of the inner surface of the inner tube 50.
  • the balloon 22 is pushed out toward the tip of the outer tube 24 through the balloon lead-out hole 32a by moving the inner tube 50 in the tip direction relative to the outer tube 24.
  • the balloon 22 is formed so that the color of the inner surface of the balloon 22 is different from the color of the inner surface of the oviduct (for example, yellowish green). Thereby, it is possible to easily grasp whether or not the tip of the fallopian tube mirror 15 is located in the balloon 22.
  • a bag-shaped outer space S with a closed tip is formed between the balloon 22 and the outer tube 24.
  • the inside of the balloon 22 opens toward the tip.
  • the fluid supply device 14 forms a flow path forming a supply device main body 70 for sending the fluid and a supply flow path 72 for supplying the fluid sent from the supply device main body 70 to the balloon catheter 12. It has a part 74 and.
  • the supply device main body 70 is a pump for sending a fluid of a predetermined pressure.
  • the fluid for example, physiological saline is used.
  • the supply flow path 72 is a first supply flow path 72a that guides the fluid sent from the supply device main body 70 to the introduction port 38 (outer lumen 54) of the outer pipe hub 26, and the fluid flowing through the first supply flow path 72a. It has a second supply flow path 72b that leads a part to the introduction port 62 (inner lumen 56) of the inner tube hub 52.
  • the flow path forming portion 74 includes a first tube 76, a branch connector 78, a second tube 80, a first connector 82, a third tube 84, and a second connector 86.
  • One end of the first tube 76 is connected to the supply device main body 70.
  • the other end of the first tube 76 is connected to the first branch port portion 78a of the branch connector 78.
  • One end of the second tube 80 is connected to the second branch port 78b of the branch connector 78.
  • a first connector 82 that can be attached to and detached from the port forming portion 40 is provided.
  • One end of the third tube 84 is connected to the third branch port 78c of the branch connector 78.
  • a second connector 86 that can be attached to and detached from the port forming portion 64 is provided.
  • the first tube 76, the first branch port portion 78a of the branch connector 78, the second branch port portion 78b of the branch connector 78, and the second tube 80 form a first supply flow path 72a.
  • the third branch port portion 78c and the third tube 84 of the branch connector 78 form a second supply flow path 72b.
  • the supply device main body 70 has a control unit 90 inside.
  • the control unit 90 comprehensively controls the entire supply device main body 70.
  • a microcomputer is used in the control unit 90 to read a predetermined program and execute software processing in cooperation with each functional unit.
  • the control unit 90 includes a fluid supply control unit 92 and a mode switching unit 94.
  • the fluid supply control unit 92 controls the start and stop of the fluid supply from the supply device main body 70 based on the signal from the operation switch 96 (see FIGS. 1 and 3).
  • the operation switch 96 is electrically connected to the supply device main body 70 via a cable 98.
  • the operation switch 96 may be wirelessly connected to the control unit 90.
  • the operation switch 96 is configured as a foot switch that outputs a signal when the operator or the like steps on it. Further, the fluid supply control unit 92 controls the pressure of the fluid based on the mode (low pressure mode or high pressure mode) selected by the mode switching unit 94.
  • the mode switching unit 94 switches between a low pressure mode in which the fluid pressure is set to the first pressure and a high pressure mode in which the fluid pressure is set to a second pressure higher than the first pressure.
  • the low pressure mode is a mode selected when the oviduct mirror 15 is retracted with respect to the balloon 22, and the high pressure mode is a mode selected when the balloon 22 is inflated.
  • the first pressure and the second pressure can be appropriately set by a setting button (input unit) or the like (not shown) provided on the main body 70 of the supply device.
  • the first pressure is preferably set to, for example, 1 atm or more and 4 atm or less.
  • the second pressure is preferably set to 6 atm or more and 10 atm or less.
  • the mode switching unit 94 switches between the low voltage mode and the high voltage mode based on the input signal from the operation switch 96. In other words, the mode switching unit 94 switches the mode based on the amount of depression of the operation switch 96. Specifically, the mode switching unit 94 selects the low-voltage mode when the depression amount of the operation switch 96 is small (the operation switch 96 is lightly depressed), and the depression amount of the operation switch 96 is large (the operation switch 96 is strongly depressed). However, select the high pressure mode.
  • the operation switch 96 is not limited to the foot switch, and may be any switch as long as it can be operated by an operator or the like.
  • the fallopian tube mirror 15 is inserted into the second lumen 50a of the inner tube 50 from the proximal end side of the inner catheter 20.
  • the tip of the fallopian tube mirror 15 is positioned closer to the proximal end side (for example, inside the balloon 22) than the tip of the outer tube 24.
  • the inner pipe 50 is fixed by the fixing screw 28 in a state where the inner pipe 50 is completely pulled toward the base end side.
  • the slider 18 is slid toward the tip of the outer tube 24 to straighten the tip side of the outer tube 24.
  • step S2 the balloon catheter 12 is inserted transcervically to the uterine cavity 200.
  • step S3 the slider 18 is pulled back to the base end side.
  • the tip end side of the outer pipe body 30 is exposed from the slider 18, and the restraint of the slider 18 is released. Therefore, the tip end side of the outer tube main body 30 has a curved shape.
  • the operator operates the outer tube hub 26 to bring the tip of the outer tube 24 closer to the oviduct opening 202a of the oviduct 202.
  • step S4 the operator advances the fallopian tube mirror 15 so that the tip of the fallopian tube mirror 15 is located at the tip of the outer tube 24 (the tip opening of the balloon lead-out hole 32a).
  • step S5 the fixing of the inner tube 50 to the outer catheter 16 is released by loosening the tightening of the fixing screw 28.
  • step S6 the fallopian tube mirror 15 is pulled back to the proximal end side by a predetermined distance (for example, 2 cm). Subsequently, the balloon derivation step (step S7) is performed.
  • the fluid sent from the supply device main body 70 is pressurized in the pressurizing step (step S9 in FIG. 5). Specifically, the operator strongly steps on the operation switch 96. Then, since the mode switching unit 94 selects the high pressure mode, the fluid supply control unit 92 increases the pressure of the fluid so as to enter the high pressure mode. That is, the fluid supply control unit 92 sets the pressure of the fluid sent from the supply device main body 70 to the second pressure.
  • the fluid sent from the supply device main body 70 is supplied to the outer space S of the balloon 22 via the first supply flow path 72a, the introduction port 38, the first space 34, and the outer lumen 54.
  • the outer space S is a bag-shaped space with a closed tip, the fluid supplied to the outer space S becomes a second pressure.
  • the fluid branched from the first supply flow path 72a to the second supply flow path 72b is supplied to the inside of the balloon 22 via the introduction port 62, the second space 58, and the inner lumen 56.
  • the flow path cross-sectional area of the inner lumen 56 is smaller than the flow path cross-sectional area of the outer lumen 54, pressure loss occurs when the fluid flows through the inner lumen 56.
  • the fluid supplied to the inside of the balloon 22 flows out toward the tip of the outer tube 24 through the balloon lead-out hole 32a. Therefore, inside the balloon 22, the pressure of the fluid becomes lower than the second pressure.
  • the balloon 22 is elastically deformed by being pressed inward in the radial direction by the fluid supplied to the outer space S. That is, the portion of the balloon 22 located on the outer peripheral side of the fallopian tube mirror 15 is in close contact with the outer peripheral surface of the fallopian tube mirror 15. The inner surfaces of the balloon 22 located closer to the tip of the fallopian tube mirror 15 are in contact with each other.
  • step S10 the operator operates the inner tube hub 52 to advance the inner tube 50 with respect to the outer tube 24. Then, the balloon 22 pushed toward the tip by the inner tube 50 advances with respect to the outer tube 24 together with the oviduct mirror 15. At this time, since one end of the balloon 22 is fixed to the tip of the outer tube 24, the balloon 22 moves forward while the tip of the balloon 22 is turned over. That is, the balloon 22 is turned up at its tip so that the inner surface faces outward. Therefore, the balloon 22 advances a distance corresponding to half of the advance distance of the fallopian tube mirror 15. The advancing step is performed until the tip of the oviduct mirror 15 reaches the tip of the balloon 22.
  • the operator determines whether or not the balloon 22 has reached the lesion portion 204 based on the image of the salpingoscope 15 (step S11).
  • the fluid sent from the supply device main body 70 is depressurized in the depressurizing step (step S12). Specifically, in FIG. 10, the operator lightens the depression of the operation switch 96. Then, since the mode switching unit 94 switches from the high pressure mode to the low pressure mode, the fluid supply control unit 92 controls the pressure of the fluid so as to enter the low pressure mode. That is, the fluid supply control unit 92 reduces the pressure of the fluid sent from the supply device main body 70 to the first pressure.
  • the pressure of the fluid supplied to the outer space S is reduced from the second pressure to the first pressure, and the fluid easily flows inside the balloon 22, so that the balloon 22 elastically deforms outward in the radial direction.
  • the tightening (pressing) of the fallopian tube mirror 15 by the balloon 22 is released.
  • the fallopian tube mirror 15 is retracted by a predetermined distance (for example, 1 cm).
  • a predetermined distance for example, 1 cm.
  • the tip of the fallopian tube mirror 15 is retracted by a predetermined distance from the tip of the balloon 22.
  • step S11 of FIG. 5 when the operator determines that the balloon 22 has reached the lesion portion 204 based on the image of the salpingoscope 15, in the removal step (step S8 of FIG. 4), the surgeon determines.
  • the balloon catheter 12 is removed. The operator may determine that the balloon 22 has reached the lesion portion 204 by pulling out all the balloons 22 forward. This completes the salpingoscopic tuboplasty.
  • the catheter system 10A according to the present embodiment has the following effects.
  • the fluid supply device 14 has a supply device main body 70 for sending the fluid, and a supply flow path 72 for supplying the fluid guided from the supply device main body 70 to the outer lumen 54 and the inner lumen 56.
  • the supply device main body 70 includes a mode switching unit 94 that switches between a low pressure mode in which the pressure of the fluid is set to the first pressure and a high pressure mode in which the pressure of the fluid is set to a second pressure higher than the first pressure.
  • the fluid sent from the supply device main body 70 to the supply flow path 72 is supplied to the outer space S of the balloon 22 via the outer lumen 54 and the balloon 22 via the inner lumen 56. Supplied inside.
  • the mode switching unit 94 selects the high pressure mode
  • the pressure of the fluid supplied to the bag-shaped outer space S with the tip closed becomes the second pressure.
  • the fluid supplied to the inside of the annular balloon 22 flows out from the tip opening of the balloon 22.
  • pressure loss occurs when the fluid flows through the inner lumen 56. Therefore, the pressure of the fluid supplied to the inside of the balloon 22 becomes lower than the second pressure. Therefore, the balloon 22 can be inflated inward in the radial direction by the fluid supplied to the outer space S and brought into close contact with the outer peripheral surface of the oviduct mirror 15. Therefore, the balloon 22 and the fallopian tube mirror 15 can be moved forward. Therefore, the balloon 22 can be advanced toward the tip end side of the outer tube 24 together with the oviduct mirror 15.
  • the mode switching unit 94 selects the low pressure mode
  • the fluid supplied to the outer space S drops from the second pressure to the first pressure, so that the fluid easily flows between the balloon 22 and the fallopian tube mirror 15. Become. Therefore, the fallopian tube mirror 15 can be efficiently retracted with respect to the balloon 22.
  • the mode switching unit 94 can change the pressure between the fluid supplied to the inside of the balloon 22 and the fluid supplied to the outer space S of the balloon 22. Therefore, the balloon derivation process can be efficiently performed with a simple configuration.
  • the fluid supply device 14 has an operation switch 96, and the mode switching unit 94 switches between the low pressure mode and the high pressure mode based on the signal from the operation switch 96.
  • the operation switch 96 is a foot switch.
  • the operator can switch between the low pressure mode and the high pressure mode by stepping on the foot switch while operating the balloon catheter 12 with his fingers. That is, since an assistant for operating the operation switch 96 is not required, the man-hours required for the operation using the catheter system 10A can be reduced.
  • the balloon catheter 12 includes an outer tube hub 26 provided at the proximal end of the outer tube 24 and an inner tube hub 52 provided at the proximal end of the inner tube 50.
  • the outer tube hub 26 is formed with an introduction port 38 communicating with the outer lumen 54
  • the inner tube hub 52 is formed with an introduction port 62 communicating with the inner lumen 56.
  • the supply flow path 72 includes a first supply flow path 72a that guides the fluid sent from the supply device main body 70 to the introduction port 38, and a second supply flow path 72a that guides a part of the fluid flowing through the first supply flow path 72a to the introduction port 62. Includes supply flow path 72b.
  • the catheter system 10B includes a balloon catheter 12a, a fluid supply device 14a, and a fallopian tube mirror 15.
  • the balloon catheter 12a has an inner catheter 20a instead of the inner catheter 20 described above.
  • the inner tube 100 of the inner catheter 20a is formed with a communication hole 102 that allows the inner lumen 56 and the outer lumen 54 to communicate with each other.
  • the inner tube 100 is a tube body having a second lumen 100a penetrating from the tip end to the base end.
  • the communication hole 102 is located on the tip side of the first seal member 42 in the retracted state (initial state) of the balloon 22.
  • the port forming portion 64 described above is not formed on the inner tube hub 52a of the inner catheter 20a.
  • the fluid supply device 14a has a flow path forming portion 104 that forms the supply flow path 104a.
  • the flow path forming portion 104 includes a tube 106 and a connector 108.
  • the tube 106 connects the supply device main body 70 and the connector 108 to each other.
  • the connector 108 is configured to be detachably attached to the port forming portion 40.
  • the fluid sent from the supply device main body 70 is supplied to the outer space S of the balloon 22 via the supply flow path 104a, the introduction port 38, the first space 34, and the outer lumen 54. Further, a part of the fluid supplied to the outer lumen 54 is guided to the inner lumen 56 through the communication hole 102 and supplied to the inside of the balloon 22.
  • the balloon catheter 12a includes an outer tube hub 26 provided at the proximal end portion of the outer tube 24.
  • the outer tube hub 26 is formed with an introduction port 38 communicating with the outer lumen 54, and the supply flow path 104a supplies the fluid sent from the supply device main body 70 to the introduction port 38.
  • the inner pipe 100 is formed with a communication hole 102 that allows the outer lumen 54 and the inner lumen 56 to communicate with each other.
  • the configuration of the fluid supply device 14a can be simplified. Further, the configuration of the inner pipe hub 52a can be simplified.
  • a 100) and an annular balloon (22) that connects the tip of the outer tube and the tip of the inner tube to each other and swells inward in the radial direction of the outer tube are provided.
  • a bag-shaped outer space (S) having a closed tip is formed between the balloon and the outer tube, and between the inner tube and the outer tube, a bag-shaped outer space (S) is formed.
  • An outer lumen (54) for supplying the fluid is provided in the outer space, and in a state where the medical wire is inserted, between the inner tube and the medical wire, inside the balloon.
  • a catheter system comprising a mode switching unit (94) that switches the pressure of the fluid to a high pressure mode that sets the pressure of the fluid to a second pressure higher than the first pressure.
  • the fluid supply device has an operation switch (96), and the mode switching unit may switch between the low pressure mode and the high pressure mode based on a signal from the operation switch.
  • the operation switch may be a foot switch.
  • the balloon catheter comprises an outer tube hub (26) provided at the proximal end of the outer tube and an inner tube hub (52) provided at the proximal end of the inner tube.
  • the outer tube hub is formed with a first introduction port (38) communicating with the outer lumen
  • the inner tube hub is formed with a second introduction port (62) communicating with the inner lumen.
  • the supply flow path includes a first supply flow path (72a) that guides the fluid sent from the supply device main body to the first introduction port, and a part of the fluid that flows through the first supply flow path.
  • a second supply flow path (72b) leading to the second introduction port may be included.
  • the balloon catheter comprises an outer tube hub provided at the proximal end of the outer tube, the outer tube hub being formed with an introduction port (38) communicating with the outer fluid.
  • the supply flow path supplies the fluid sent from the supply device main body to the introduction port, and the inner pipe is formed with a communication hole (102) for communicating the outer lumen and the inner lumen with each other. You may.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un système de cathéter (10A) pourvu d'un cathéter à ballonnet (12) et d'un dispositif d'alimentation en fluide (14). Le cathéter à ballonnet (12) est pourvu d'un ballonnet annulaire (22) reliant l'extrémité distale d'un tube externe (24) et l'extrémité distale d'un tube interne (50). Le dispositif d'alimentation en fluide (14) comporte un circuit d'alimentation (72) pour fournir un fluide guidé à partir d'un corps principal de dispositif d'alimentation (70) vers une lumière externe (54) et une lumière interne (56). Le corps principal de dispositif d'alimentation (70) comprend une unité de commutation de mode (94) qui transite entre un mode basse pression pour régler la pression du fluide à une première pression, et un mode haute pression pour régler la pression du fluide à une seconde pression, supérieure à la première pression.
PCT/JP2020/034243 2019-09-26 2020-09-10 Système de cathéter WO2021059992A1 (fr)

Priority Applications (2)

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CN202080052568.1A CN114144220B (zh) 2019-09-26 2020-09-10 导管系统
JP2021548783A JPWO2021059992A1 (fr) 2019-09-26 2020-09-10

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JP2019-175408 2019-09-26
JP2019175408 2019-09-26

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WO2021059992A1 true WO2021059992A1 (fr) 2021-04-01

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05200120A (ja) * 1991-10-18 1993-08-10 Imagyn Medical Inc 外翻カテーテルおよび外翻カテーテルに細長い器具を位置決めする方法
JPH05509255A (ja) * 1991-10-17 1993-12-22 イマジン　メディカル　インコーポレイテッド 延長制御を行うリニア外返りカテーテル装置
JPH07506755A (ja) * 1992-12-15 1995-07-27 エステーエム、メディツィーンテヒニク、シュタルンベルク、ゲゼルシャフト、ミット、ベシュレンクテル、ハフツング 管状空洞にそって内視鏡を移動させる方法および装置
JP2003265614A (ja) * 2002-03-19 2003-09-24 Terumo Corp バルーンカテーテル

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7060062B2 (en) * 2003-06-04 2006-06-13 Cryo Vascular Systems, Inc. Controllable pressure cryogenic balloon treatment system and method
ES2367407T3 (es) * 2007-08-29 2011-11-03 Acrostak Corp. Procedimiento y equipo para la administración de braquiterapia a un sujeto.
CN104994778B (zh) * 2012-12-22 2018-01-30 奥梅齐医疗有限公司 定位和组织感应装置和方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05509255A (ja) * 1991-10-17 1993-12-22 イマジン　メディカル　インコーポレイテッド 延長制御を行うリニア外返りカテーテル装置
JPH05200120A (ja) * 1991-10-18 1993-08-10 Imagyn Medical Inc 外翻カテーテルおよび外翻カテーテルに細長い器具を位置決めする方法
JPH07506755A (ja) * 1992-12-15 1995-07-27 エステーエム、メディツィーンテヒニク、シュタルンベルク、ゲゼルシャフト、ミット、ベシュレンクテル、ハフツング 管状空洞にそって内視鏡を移動させる方法および装置
JP2003265614A (ja) * 2002-03-19 2003-09-24 Terumo Corp バルーンカテーテル

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JPWO2021059992A1 (fr) 2021-04-01
CN114144220A (zh) 2022-03-04

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