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WO2020060209A1 - Cathéter à ballonnet - Google Patents

Cathéter à ballonnet Download PDF

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Publication number
WO2020060209A1
WO2020060209A1 PCT/KR2019/012108 KR2019012108W WO2020060209A1 WO 2020060209 A1 WO2020060209 A1 WO 2020060209A1 KR 2019012108 W KR2019012108 W KR 2019012108W WO 2020060209 A1 WO2020060209 A1 WO 2020060209A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
tube
balloon catheter
unit
guide
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/KR2019/012108
Other languages
English (en)
Korean (ko)
Inventor
김병장
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mega Medical Co Ltd
Original Assignee
Mega Medical Co Ltd
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 Mega Medical Co Ltd filed Critical Mega Medical Co Ltd
Publication of WO2020060209A1 publication Critical patent/WO2020060209A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/24—Surgical instruments, devices or methods for use in the oral cavity, larynx, bronchial passages or nose; Tongue scrapers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering 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
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple 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
    • A61M29/02—Dilators made of swellable material
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/091—Guide wires having a lumen for drug delivery or suction
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments

Definitions

  • the present invention relates to a balloon catheter. Specifically, the present invention, the position of the balloon is changed according to the position change of the guide portion by the operation unit, the tube and the guide portion has a flexible (flexible) feature, when the bending angle of the tube and the guide portion is specified in advance, corresponds to a predetermined angle It relates to a balloon catheter characterized in that the tube and the guide portion is bent at a predetermined timing.
  • the sinuses are hollow rivers in the skull, connected to the nasal cavity by small openings known as small pores.
  • Each pore between the sinuses and nasal cavity is formed by bones covered by a layer of mucosal tissue.
  • mucosal tissue usually, air passes through the small pores into the sinuses and out of the sinuses.
  • mucus continues to be formed by the inner layer of the mucous membrane of the sinuses, and exits through the pores and into the nasal cavity.
  • Sinusitis is a general term referring to inflammation in one or more sinuses.
  • Acute sinusitis can be associated with infections or allergic diseases that can cause tissue swelling and temporarily interfere with normal pore-via discharge and aeration of the sinuses, causing some accumulation of mucus and possibly infection in the sinuses.
  • Chronic sinusitis is a long-term disease characterized by persistent stenosis or blockage of one or more sinus cavities, causing chronic infection and inflammation of the sinuses.
  • Chronic sinusitis is often associated with long-lasting respiratory allergies, nasal polyps, hypertrophic nasal turbinitis and / or septal curvature.
  • Acute sinusitis is typically caused by infection with a single pathogen (e.g., one type of bacteria, one type of virus, one type of fungus, etc.), while chronic sinusitis is caused by multiple pathogen infections (e.g. For example, it is often associated with more than one type of bacteria or more than one type of microorganisms).
  • pathogen e.g., one type of bacteria, one type of virus, one type of fungus, etc.
  • chronic sinusitis is caused by multiple pathogen infections (e.g. For example, it is often associated with more than one type of bacteria or more than one type of microorganisms).
  • Chronic sinusitis if left untreated, can result in irreparable damage to tissue and / or bone structures of the paranasal anatomical structures.
  • Initial treatment of chronic sinusitis usually involves the use of drugs such as decongestants, steroid nasal sprays, and antibiotics (if the infection is bacterial). Surgical intervention may be recommended in cases where drug treatment alone fails to cure.
  • FESS endoscopic sinus surgery
  • a technique known as the Balloon Sinuplasty procedure and a system for performing this procedure were developed by Acclarent Inc, Menlo Park, California, USA, for the treatment of sinusitis.
  • a number of U.S. patents and patent applications including U.S. Pat.Nos. 7645272, 7654997, and 7803150, describe various embodiments of balloon sinus surgery procedures as well as various devices that can be used to perform such procedures.
  • a guide catheter is inserted into the nose and positioned within or adjacent to the small sinus of the affected sinus. The guidewire is then advanced through the guide catheter and into the affected sinus.
  • an expansion catheter with an expandable dilator eg, an inflatable balloon
  • an expandable dilator eg, an inflatable balloon
  • the dilator is then enlarged, causing enlargement of the pores and remodeling of the bone adjacent to the pores, without requiring incision of the mucous membrane or removal of any bone.
  • the catheter and guidewire are then removed, and the enlarged pores allow improved evacuation from the onset sinus and its aeration.
  • washing the sinuses may be useful or necessary.
  • the device described in US Patent Publication No. 2008/0183128 can be used to clean the sinuses.
  • the washing catheter can be advanced through the guide catheter and into the small or sinus, for example, for the purpose of washing, aspiration, mass transfer and culture recovery.
  • the present invention relates to a balloon catheter, the position of the balloon is changed according to the position change of the guide portion by the operation unit, the tube and the guide portion has a flexible feature (flexible), when the bending angle of the tube and the guide portion is specified in advance, in advance It is intended to provide a user with a balloon catheter, characterized in that the tube and the guide portion are bent at a predetermined timing in correspondence with a specified angle.
  • An inflatable catheter related to an example of the present invention for realizing the above-described problem includes a tube; A guide part inserted into one end of the tube and exposed to the other end; An operation portion connected to one end of the tube and changing the position of the guide portion; An inflatable balloon provided on at least a portion of the guide portion exposed to the other end of the tube; And an input unit connected to at least a part of the manipulation unit and supplying at least one of gas and liquid to the interior of the tube, wherein the position of the balloon changes according to the position change of the guide unit by the manipulation unit,
  • the tube and the guide portion are flexible, and when the bending angle of the tube and the guide portion is previously specified, the tube and the guide portion may be bent at a predetermined timing in correspondence with the predetermined angle.
  • a user manipulation unit for transmitting a triggering signal to bend the tube and the guide unit in response to the predetermined angle may be further included.
  • the tube and the guide part are replaceable, and the angles of bend of the tube and the guide part to be replaced may be different from each other.
  • the inside of the tube may be divided into a plurality of regions.
  • gas for expanding the balloon may be introduced into the first region of the plurality of regions, and liquid for ejecting into the region adjacent to the balloon catheter may be introduced into the second region of the plurality of regions.
  • an additive for hemostasis may be introduced into the second region.
  • liquid ejected through the second region may be sucked back into the third region of the plurality of regions.
  • the end of the third region that sucks the liquid may be able to change the suction angle according to the operation of the operation unit.
  • a sensor may be introduced into a fourth region of the plurality of regions, and a communication unit configured to transmit the location of the balloon catheter sensed by the sensor to an external navigation.
  • the end of the guide unit may further include; an output unit for outputting light to the outside.
  • the balloon is double, it is possible to input a predetermined fluid into the space between the first balloon inside and the second balloon out of the double balloon, the needle provided in at least part of the second balloon Through this, the predetermined fluid can be discharged.
  • the inside of the tube is provided with at least one injection control unit which is an empty space extending upward, and the bending angle of the tube and the guide unit changes as the empty space area of the injection control unit changes by manipulation of the operation unit.
  • the present invention relates to a balloon catheter, the position of the balloon is changed according to the position change of the guide portion by the operation unit, the tube and the guide portion has a flexible feature (flexible), when the bending angle of the tube and the guide portion is specified in advance, in advance It is possible to provide the user with a balloon catheter, characterized in that the tube and the guide portion are bent at a predetermined timing in correspondence with a specified angle.
  • FIG. 1 is a view showing a technology trend related to sinus surgery in relation to the present invention.
  • Figure 2 shows an example of a block diagram associated with the balloon catheter and supply unit proposed by the present invention.
  • Figure 3a shows an example of a balloon catheter proposed by the present invention
  • Figure 3b shows an example of the inner structure of the tube.
  • Figure 4 shows a first embodiment of a balloon catheter proposed by the present invention.
  • Figure 5 shows a second embodiment of the balloon catheter proposed by the present invention.
  • FIG. 6 shows a third embodiment of the balloon catheter proposed by the present invention.
  • Figure 7 shows a flow chart of a method for supplying only a specified amount of gas according to the present invention to a balloon catheter.
  • FIG. 8 is a flowchart illustrating a method of displaying a warning message to a user at an output unit when the balloon pressure according to the present invention reaches a predetermined level.
  • FIG. 9 is a flow chart of a method in which the fluid escapes through the pressure release port and the fluid is no longer supplied to the balloon when the balloon pressure is above a predetermined level according to the present invention.
  • FIG. 10 is a view for explaining the flexible structure of the balloon catheter proposed by the present invention.
  • FIG. 11 is a view for explaining a method of moving the balloon portion to a region closer to the affected part in a state where the guide part is fixed in relation to the present invention.
  • FIG. 13 illustrates an example of a method of ejecting an additive into a region proximate a catheter in relation to the present invention.
  • FIG. 14 shows an example of a method of adjusting the drug injection according to the degree of bending of the catheter in connection with the present invention.
  • 15 illustrates an example of a method of delivering a drug to a desired site based on a double structure and a double structure in relation to the present invention.
  • 16 is a view for explaining the marketability of the balloon catheter proposed by the present invention.
  • FIG. 1 is a view showing a technology trend related to sinus surgery in relation to the present invention.
  • sinus surgery was performed through an incision before the 1990s, sinus surgery using an endoscope was performed from 1990 to 2010, and sinus surgery linked to surgical navigation was suggested since 2010. have.
  • Sinus surgery through incision surgery has the advantage of not requiring expensive equipment, but since it requires a wide range of incisions, it has the disadvantage of over-bleeding and long recovery time.
  • sinus surgery using an endoscope has the advantage of being able to perform an incision in a small area, but there is a problem in that it is difficult to grasp the anatomical position.
  • the sinus operation linked to the surgical navigation has the advantage of being able to track the anatomical position, improve accuracy and reduce the reoperation rate, but there is a problem that expensive equipment is required.
  • this specification intends to propose a balloon catheter capable of accurate surgery without expensive equipment without performing an incision.
  • Figure 2 shows an example of a block diagram associated with the balloon catheter and supply unit proposed by the present invention.
  • the balloon catheter 1 proposed by the present invention includes a balloon 10, a sensing unit 40, a communication unit 50, a guide unit 60, a display unit 70, an operation unit 30, It may include the output unit 90, the tube 20 and the input unit 80.
  • the components of the balloon catheter 1 shown in FIG. 2 are merely exemplary and may be implemented in various configurations.
  • a supply unit 200 for supplying gas, fluid, and the like may be separately provided.
  • the tube 20 may include an irrigation portion 21, a balloon portion 22, a suction portion 23, a sensor inlet portion 24, and the like.
  • the irrigation part 21 is a passage through which the saline, water, etc., introduced through the input part 80 can pass, and the balloon part 200 passes the gas input through the input part 80, and the corresponding gas is ballooned ( It is a passage that can be transmitted to 10).
  • the suction part 23 is a passage for sucking the liquid introduced through the irrigation part 21 into a specific area of the body and sucking it again to discharge it to the outside.
  • the suction portion 23 may be changed by the operation portion 30 in the suction direction corresponding to the position of the farm to be sucked.
  • the sensor inlet 24 refers to a passage through which a sensor for notifying the position of the catheter 1 and notifying the outside through the communication unit 50 is inserted.
  • the guide portion 60 is inserted into one end of the tube 20 and disposed while being exposed to the other end.
  • a balloon 10 is provided in the distal region of the guide portion 60 exposed to the other end of the tube, and the balloon 10 transfers gas from the balloon portion 200 through which the gas input through the input portion 80 passes. By receiving and expanding, it provides the function of expanding a narrow area of the surgical site.
  • the operation unit 30 is connected to one end of the tube 20, it is possible to change the position of the guide unit 60 according to the user's operation.
  • the position of the balloon 10 may be changed according to the position change of the guide part 60 by the operation part 30.
  • the tube 20 and the guide part 60 are flexible, and are bent at a predetermined angle or manually bent by the user, so that the balloon 10 can be accurately placed on the affected area. do.
  • the input unit 80 is a saline water input unit 82 for transmitting saline, water, etc. supplied from the outside to the irrigation unit 21 and a gas input unit 81 for delivering gas supplied from the outside to the balloon unit 22. It is composed.
  • the supply unit 200 that provides a function of providing a fluid such as gas or liquid to the gas input unit 81 and the plant-plant input unit 82 of the input unit 80.
  • the sensing unit 40 detects the current state of the balloon catheter 1, such as the location of the balloon catheter 1, the presence or absence of user contact, the orientation of the balloon catheter 1, acceleration / deceleration of the balloon catheter 1, and the like. A sensing signal for controlling the operation of the balloon catheter 1 is generated.
  • the sensing unit 40 may provide a function of sensing the current position of the balloon 10 among the balloon catheter 1 and transmitting it to the outside through the communication unit 50.
  • the communication unit 50 may include one or more modules that enable wired communication or wireless communication between the balloon catheter 1 and the wireless communication system or between the balloon catheter 1 and the network where the balloon catheter 1 is located. have.
  • Bluetooth radio frequency identification
  • IrDA infrared data association
  • UWB ultra-wideband
  • ZigBee ZigBee
  • TDMA code division multiple access
  • frequency division multiple access FDMA
  • time division multiple access TDMA
  • orthogonal frequency division multiple access OFDMA
  • SC-FDMA single carrier frequency division multiple access
  • the display unit 70 displays (outputs) information processed by the balloon catheter 1.
  • the display unit 70 includes a liquid crystal display (LCD), a thin film transistor-liquid crystal display (TFT LCD), an organic light-emitting diode (OLED), and a flexible display.
  • LCD liquid crystal display
  • TFT LCD thin film transistor-liquid crystal display
  • OLED organic light-emitting diode
  • flexible display may include at least one of a three-dimensional display (3D display).
  • Some of these displays may be of a transparent type or a light transmissive type so that the outside can be seen through them. This may be referred to as a transparent display, and a typical example of the transparent display is TOLED (Transparant OLED).
  • TOLED Transparant OLED
  • the rear structure of the display unit 70 may also be configured as a light transmissive structure.
  • the output unit 90 is for generating output related to vision, hearing, or tactile sense, and may include an LED light emitting unit, an audio output module, an alarm unit, and the like.
  • Figure 3a shows an example of a balloon catheter proposed by the present invention
  • Figure 3b shows an example of the inner structure of the tube.
  • the balloon 10 is provided in the distal region of the guide portion 60 exposed to the other end of the tube, the balloon 10 is a balloon 200 through which the gas input through the input unit 80 passes It provides the function of expanding a narrow area of the surgical site by receiving gas from and expanding it.
  • the tube 20 may include an irrigation portion 21, a balloon portion 22, a suction portion 23, a sensor inlet portion 24, and the like.
  • the irrigation part 21 of the tube 20 is a passage through which the saline, water, etc., which have flowed through the input part 80, can pass, and the balloon part 200 is input through the input part 80.
  • the gas passes, and is a passage through which the input gas can be delivered to the balloon 10.
  • suction portion 23 of the tube 20 is a passage for sucking the liquid introduced through the irrigation portion 21 into a specific region of the body and sucking it again to discharge it to the outside.
  • the sensor inlet 24 refers to a passage through which a sensor for notifying the position of the catheter 1 and notifying the outside through the communication unit 50 is inserted.
  • the operation unit 30 is connected to one end of the tube 20, and the position of the guide unit 60 can be changed according to the user's operation.
  • the position of the balloon 10 may be changed according to the position change of the guide part 60 by the operation part 30.
  • the tube 20 and the guide part 60 are flexible, and are bent at a predetermined angle or manually bent by the user, so that the balloon 10 can be accurately placed on the affected area. do.
  • the input unit 80 is a saline water input unit 82 for transmitting saline, water, etc. supplied from the outside to the irrigation unit 21 and a gas input unit 81 for delivering gas supplied from the outside to the balloon unit 22. It is composed.
  • the supply unit 200 that provides a function of providing a fluid such as gas or liquid to the gas input unit 81 and the plant-plant input unit 82 of the input unit 80.
  • Figure 4 shows a first embodiment of a balloon catheter proposed by the present invention.
  • the first embodiment balloon catheter 1 shown in FIG. 4 can be applied to the sinus, a hole in the skull, leading to the inside of the nose.
  • a balloon 10 is provided in a distal region of the guide portion 60 exposed to the other end of the tube 20, and the balloon 10 is a balloon portion through which the gas input through the input portion 80 passes By receiving the gas from the 200 and expanding it, a narrow area of the surgical site can be expanded.
  • the operation unit 30 is connected to one end of the tube 20, it is possible to change the position of the guide unit 60 according to the user's operation. At this time, the position of the balloon 10 may be changed according to a change in the position of the guide unit 60 by the operation unit 30.
  • the tube 20 and the guide part 60 are flexible, and are bent at a predetermined angle or manually bent by the user, so that the balloon 10 can be accurately placed on the affected area. do.
  • the input unit 80 receives saline, water, gas, etc. supplied from the outside.
  • Figure 5 shows a second embodiment of the balloon catheter proposed by the present invention.
  • the second embodiment balloon catheter 1 shown in FIG. 5 is applicable to an eustachian tube.
  • the balloon 10 is provided in an area moved a certain distance closer to the tube than the end of the guide part 60 exposed to the other end of the tube 20, and the balloon 10 is an input part 80
  • the balloon 10 is an input part 80
  • the operation unit 30 is connected to one end of the tube 20, it is possible to change the position of the guide unit 60 according to the user's operation.
  • the tube 20 and the guide part 60 are flexible, and are bent at a predetermined angle or manually bent by the user, so that the balloon 10 can be accurately placed on the affected area. do.
  • the input unit 80 is a saline water input unit 82 for transmitting saline, water, etc. supplied from the outside to the irrigation unit 21 and a gas input unit 81 for delivering gas supplied from the outside to the balloon unit 22. It is composed.
  • the supply unit 200 that provides a function of providing a fluid such as gas or liquid to the gas input unit 81 and the plant-plant input unit 82 of the input unit 80.
  • FIG. 6 shows a third embodiment of the balloon catheter proposed by the present invention.
  • the structures of the balloon 10, the tube 20, the operation unit 30, and the guide unit 60 are the same as those of the first and second embodiments described above, and thus, redundant descriptions are omitted for the sake of simplicity in the specification. .
  • the balloon catheter 1 of the third embodiment shown in FIG. 6 can be applied to a sinus and an eustachian tube, and is characterized in that it has an output unit 90 with a luminous body.
  • the light is output from the output unit 90 of the balloon catheter 1 inserted inside the body, and the light penetrates the body skin and is emitted outside, and the operator or operator is based on the light of the balloon catheter 1
  • the current location can be determined without using navigation or the like.
  • a power supply unit 92 for supplying power to the output unit 90 may be separately provided, and an optical fiber 91 for transmitting light may be inserted into the tube 20 up to the output unit 90 to be connected for a long time.
  • the tube 20 and the guide portion 60 are flexible, and by bending at a predetermined angle or manually bending by the user, the balloon 10 can be accurately placed on the affected area.
  • Figure 7 shows a flow chart of a method for supplying only a specified amount of gas according to the present invention to a balloon catheter.
  • a step S11 in which a user designates an amount of gas to be introduced into the input unit 80 is performed.
  • designating the amount of gas to be introduced may be performed through a user command input unit provided in the catheter 1 or a user command input unit provided in the supply unit 200.
  • a step S12 in which the supply unit 200 introduces gas into the gas input unit 81 according to the designated information proceeds, and when the specified amount is injected, a step S13 in which the supply unit stops the gas supply operation. .
  • the user can easily control to supply only the desired gas to the balloon 10 in consideration of the type of balloon, the position of the affected area, the volume to be expanded, and the like.
  • FIG. 8 is a flowchart illustrating a method of displaying a warning message to a user at an output unit when the balloon pressure according to the present invention reaches a predetermined level.
  • a step (S21) in which the user pushes the supply unit 200 to supply fluid to the balloon 10 is performed.
  • the step of supplying fluid to the balloon 10 precisely while the user rotates the rotation bar little by little based on the precision rotation inlet part of the supply unit 200 is performed (S22). .
  • the output unit 90 or the display unit 70 may display a warning message to the user (S23).
  • the user can stop the gas input through the supply unit 200 by viewing the information displayed on the output unit 90 or the display unit 70.
  • a method of allowing fluid to escape through the pressure release port may be applied.
  • FIG. 9 is a flow chart of a method in which the fluid escapes through the pressure release port and the fluid is no longer supplied to the balloon when the balloon pressure is above a predetermined level according to the present invention.
  • the user pushes the supply unit 200 to supply fluid to the balloon (S31), and the user precisely supplies fluid to the balloon based on the precision rotation inlet of the supply unit 200. (S32).
  • a step (S33) in which the fluid is discharged through the pressure release port and the fluid is no longer supplied to the balloon is performed.
  • the user can inject only a predetermined amount of gas through the pressure release port into the balloon 10 without having to manually separate the supply unit 200.
  • step S34 of displaying a warning message to the user in the output unit 90 or the display unit 70 is performed.
  • the tube 20 and the guide portion 60 have a flexible structure, and can be bent in response to a specific area manually or automatically.
  • FIG. 10 is a view for explaining the flexible structure of the balloon catheter proposed by the present invention.
  • the tube 20 and the guide part 60 can be bent based on a flexible structure, and the tube 10 located therebetween is also bent together, so that it can be closer to a desired position inside the body more accurately. It becomes possible.
  • the tube 20 and the guide portion 60 may be manufactured in plural in a bent form at a separate angle according to the application, and can be used while being replaced according to a user's needs.
  • the balloon 10 may be changed in position in two stages.
  • FIG. 11 is a view for explaining a method of moving the balloon portion to a region closer to the affected part in a state where the guide part is fixed in relation to the present invention.
  • a step S41 in which the guide unit 60 moves to an area adjacent to the affected area is performed.
  • the guide portion 60 may be divided into a first region close to the distal end of the guide portion 60 and a second region far from the distal end.
  • the balloon is provided in at least part of the first area.
  • the guide portion 60 is fixed (S42) in which the balloon portion 10 moves to a region closer to the affected portion in a fixed state.
  • the position of the guide unit 60 when the position of the guide unit 60 is changed by the operation unit 30, while the position of the second area is fixed, the position of the first area may be additionally changed by the operation unit 30, and the first area The location of the balloon may be further changed according to the additional location change of the region.
  • the balloon 10 is expanded (S43) and the lesion-related treatment is performed (S44).
  • the user can more accurately place the balloon 10 to the point to be expanded, it is possible to increase the accuracy of the procedure or surgery.
  • the situation around the affected area may not be grasped, or impurities may be disposed around the affected area, which may cause problems such as expansion of the balloon 10.
  • FIG. 12 shows an example of a light and brush provided at the end of a tube in connection with the present invention.
  • the lighting output unit 90 may be placed in an area adjacent to the balloon 10 to grasp the situation around the affected area, and a separate brush 608 may be disposed to brush impurities disposed around the affected area 608. ).
  • the tube 20 may include an irrigation portion 21, a balloon portion 22, a suction portion 23, a sensor inlet portion 24, etc.
  • the irrigation portion 21 may include an input portion 80 ) Is a passage through which the saline, water, etc., which have flowed through.
  • the irrigation unit 21 may be used not only as a passage for leaves, such as plant leaves and water, which are introduced to discharge the farms disposed inside the sinuses, but also as a passage for adding additives such as a hemostatic agent to prevent bleeding. .
  • FIG. 13 illustrates an example of a method of ejecting an additive into a region proximate a catheter in relation to the present invention.
  • the additive 100 may be introduced through the irrigation portion 21 on the tube 20 under the control of the operation portion 30.
  • FIG. 14 shows an example of a method of adjusting the drug injection according to the degree of bending of the catheter in connection with the present invention.
  • a plurality of injection adjusting portions 141 which are empty spaces extending upward, may be disposed inside the tube 20.
  • the empty space area of the injection adjustment unit 141 may be narrowed or widened, and when it is narrowed, the injection adjustment unit 141 becomes thinner and rises in a certain direction, resulting in a tube 20 ) And the guide portion 60 can be bent.
  • the drug cannot be discharged through the discharge portion 131 disposed at the end of the guide portion 60.
  • the injection control unit 141 becomes an original shape again, and the tube 20 and the guide unit 60 are parallel. It is arranged, in this case, the drug can be discharged through the discharge portion 131 disposed at the end of the guide portion 60.
  • 15 illustrates an example of a method of delivering a drug to a desired site based on a double structure and a double structure in relation to the present invention.
  • the balloon 10 may be implemented as a double, and may be provided as an outer balloon 320 and an inner balloon 310.
  • the outer balloon 320 is provided with a fine needle 330 can be discharged fluid.
  • the fluid is not directly injected, but preferentially expands the inner balloon 310 to be located close to the desired affected area, and then a predetermined fluid is discharged through the needle provided in the outer balloon 320 to the desired site. It is possible to treat against.
  • 16 is a view for explaining the marketability of the balloon catheter proposed by the present invention.
  • the balloon catheter is widely used in the cardiovascular system, musculoskeletal system, respiratory system, urinary system, and the like.
  • the worldwide catheter market is expected to grow rapidly to KRW 51 trillion by 2020, and the US sinus surgical balloon catheter market is growing 60% annually from KRW 60 billion in 2012 to KRW 240 billion in 2015.
  • the present invention relates to a balloon catheter, the position of the balloon is changed according to a change in the position of the guide portion by the operation portion, the tube and the guide portion have a flexible feature, and the amount of gas injected into the tube is specified in advance.
  • the input unit may provide the user with a balloon catheter having an odd feature such that only a gas corresponding to a predetermined amount is introduced into the tube.
  • the present invention relates to a balloon catheter, in which the position of the balloon is changed according to the position change of the guide portion by the operation portion, the tube and the guide portion have a flexible feature, and the bending angle of the tube and the guide portion is previously specified , It is possible to provide the user with a balloon catheter, characterized in that the tube and the guide portion are bent at a predetermined timing in correspondence with a predetermined angle.
  • the above-described method can be implemented as code readable by a processor on a medium on which a program is recorded.
  • Examples of the medium readable by the processor include ROM, RAM, CD-ROM, magnetic tape, floppy disk, optical data storage device, and the like, and implemented in the form of a carrier wave (for example, transmission through the Internet). Includes.
  • the laser lipolysis apparatus and the control method described above are not limited to the configuration and method of the above-described embodiments, and the above-described embodiments may be partially or entirely of each embodiment so that various modifications can be made. It may be configured in an optional combination.

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Abstract

La présente invention concerne un cathéter à ballonnet. Un mode de réalisation de la présente invention concerne un cathéter à ballonnet comprenant : un tube ; une partie de guidage insérée à une extrémité du tube et exposée à l'autre extrémité du tube ; une partie commande qui est reliée à une extrémité du tube et change la position de la partie de guidage ; un ballonnet expansible disposé dans au moins une partie de la partie de guidage exposée à l'autre extrémité du tube ; et une partie entrée qui est reliée à au moins une partie de la partie commande et qui alimente un gaz et/ou un liquide dans le tube, la position du ballonnet changeant en fonction du changement de position de la partie de guidage au moyen de la partie commande, et le tube et la partie de guidage étant flexibles et pouvant être pliés à un moment prédéfini selon un angle prédéfini, si l'angle selon lequel le tube et la partie de guidage se plient est préréglé.
PCT/KR2019/012108 2018-09-19 2019-09-19 Cathéter à ballonnet Ceased WO2020060209A1 (fr)

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KR10-2018-0112216 2018-09-19
KR1020180112216A KR102209283B1 (ko) 2018-09-19 2018-09-19 수술용 가이드 연동 풍선 카테터

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PCT/KR2019/012108 Ceased WO2020060209A1 (fr) 2018-09-19 2019-09-19 Cathéter à ballonnet

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Cited By (1)

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CN113491843A (zh) * 2020-04-02 2021-10-12 麦格(韩国)医疗器械有限公司 气囊导管

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KR20130107304A (ko) * 2010-09-22 2013-10-01 아클라런트, 인코포레이션 부비동 개방부의 처치를 위한 의료 장치
WO2014147868A1 (fr) * 2013-03-22 2014-09-25 株式会社 塚田メディカルリサーチ Cathéter pour le traitement de la sinusite
US20160228136A1 (en) * 2012-09-24 2016-08-11 Cook Medical Technologies Llc Medical Devices for the Identification and Treatment of Bodily Passages
JP2018083075A (ja) * 2016-11-25 2018-05-31 ギル メディカル センターＧｉｌ Ｍｅｄｉｃａｌ Ｃｅｎｔｅｒ 曲げ角度とバルーンの位置を調節できる副鼻腔用バルーンカテーテル
KR20180079372A (ko) * 2015-10-30 2018-07-10 아클라런트, 인코포레이션 외과용 기구의 내비게이션을 위한 시스템 및 방법

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KR101157312B1 (ko) 2007-01-25 2012-07-03 워쏘우 오르쏘페딕 인코포레이티드 수술용 내비게이션 및 신경감시 기구

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KR20130107304A (ko) * 2010-09-22 2013-10-01 아클라런트, 인코포레이션 부비동 개방부의 처치를 위한 의료 장치
US20160228136A1 (en) * 2012-09-24 2016-08-11 Cook Medical Technologies Llc Medical Devices for the Identification and Treatment of Bodily Passages
WO2014147868A1 (fr) * 2013-03-22 2014-09-25 株式会社 塚田メディカルリサーチ Cathéter pour le traitement de la sinusite
KR20180079372A (ko) * 2015-10-30 2018-07-10 아클라런트, 인코포레이션 외과용 기구의 내비게이션을 위한 시스템 및 방법
JP2018083075A (ja) * 2016-11-25 2018-05-31 ギル メディカル センターＧｉｌ Ｍｅｄｉｃａｌ Ｃｅｎｔｅｒ 曲げ角度とバルーンの位置を調節できる副鼻腔用バルーンカテーテル

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113491843A (zh) * 2020-04-02 2021-10-12 麦格(韩国)医疗器械有限公司 气囊导管

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