WO2022154138A1 - Dispositif de pulvérisation de matériau de pansement pour ulcère gastroduodénal - Google Patents

Dispositif de pulvérisation de matériau de pansement pour ulcère gastroduodénal Download PDF

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Publication number
WO2022154138A1
WO2022154138A1 PCT/KR2021/000506 KR2021000506W WO2022154138A1 WO 2022154138 A1 WO2022154138 A1 WO 2022154138A1 KR 2021000506 W KR2021000506 W KR 2021000506W WO 2022154138 A1 WO2022154138 A1 WO 2022154138A1
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WO
WIPO (PCT)
Prior art keywords
component
catheter
compressed gas
injection device
channel
Prior art date
Application number
PCT/KR2021/000506
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English (en)
Korean (ko)
Inventor
이종승
이동기
최승환
김영진
정연철
브이. 단친유알렉세이
Original Assignee
(주)앰틱스바이오
(주)얼라인드제네틱스
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 (주)앰틱스바이오, (주)얼라인드제네틱스 filed Critical (주)앰틱스바이오
Priority to PCT/KR2021/000506 priority Critical patent/WO2022154138A1/fr
Publication of WO2022154138A1 publication Critical patent/WO2022154138A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • 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

Definitions

  • the present invention relates to a peptic ulcer wound dressing spraying device and method, and more particularly, to an endoscopic wound dressing spraying device and method.
  • Gastrointestinal bleeding is one of the major factors contributing to morbidity and mortality worldwide. Gastrointestinal bleeding is a clinical problem that occurs frequently in the upper gastrointestinal tract, and the difficulty of managing gastrointestinal bleeding depends on its location and severity.
  • Hemostatic treatment methods widely used to date include injection of tissue adhesives such as epinephrine and cyanoacrylate, contact ablation therapy such as thermal coagulation using a heater probe and bipolar hemostatic forceps, and non-contact methods such as photodynamic therapy and argon plasma coagulation. , band ligation, mechanical topography such as endoscopic hemo clips and over-the scope clips. Despite their effectiveness, these approaches are reported to have a significant risk of rebleeding.
  • hemostatic powder spray products have been marketed as an effective and safe way to control upper and lower gastrointestinal bleeding.
  • An example is the Hemospray ® Endoscopic Hemostat from COOK MEDICAL, Winston-Salem, NC (see FIG. 1 ).
  • This product is a device that injects the powder contained in the container (2) of the injection device (1) through the distal end (4) of the catheter (3). Therefore, the function is limited to spraying only one component, the powder component.
  • an object of the present invention is to provide a wound dressing injection device and method capable of uniformly spraying two or more components having different viscosities to a hemostatic site in the gastrointestinal tract.
  • an object of the present invention is to provide a wound dressing injection device and method that can be maintained so as not to be mixed until two or more components are injected through the distal end of the catheter.
  • an object of the present invention is to provide a wound dressing injection device and method that can relieve the pressure increased by the clogging of the catheter tube.
  • a wound covering material injection device and method according to the present invention for achieving the above object includes the following aspects and any combination thereof.
  • One aspect of the present invention is an injection device for ejecting a substance through a catheter in which at least two separate lumens are formed, a compressed gas discharge unit, a first storage unit storing a first component, and a second storage unit storing a second component
  • a two-component catheter injection device comprising a discharge storage unit having a storage unit, a first connection unit connecting the compressed gas discharge unit and the discharge storage unit, and a second connection unit connecting the discharge storage unit and the catheter to be.
  • the first connection portion includes first and second pressurized channels for communicating the compressed gas discharge portion with the first and second storage portions, respectively, and the second connection portion includes the first and second storage portions. It is a two-component catheter injection device including first and second discharge channels for communicating the second reservoir with the lumens formed in the catheter, respectively.
  • Another aspect of the present invention is a two-component catheter injection device having a common pressurization channel connecting the first connection part between the compressed gas discharge part and the first and second pressurization channels.
  • Another aspect of the present invention is a two-component catheter injection device further comprising a pressure relief valve.
  • a pressure relief valve is installed in the common pressure channel.
  • Another aspect of the present invention is a two-component catheter injection device, wherein the second connection portion further includes a mount adapter, and the discharge channel and the lumen are connected to each other through the mount adapter.
  • the first connection portion further comprises a pressure regulating valve, wherein the pressure regulating valve is a two-component catheter injection device configured to adjust the flow rate of at least one of the first pressure channel and the second pressure channel. to be.
  • the pressure regulating valve is a two-component catheter injection device configured to adjust the flow rate of at least one of the first pressure channel and the second pressure channel. to be.
  • the pressure regulating valve is a two-component catheter device configured to control a flow rate of a pressure channel communicating with a reservoir containing a component having a relatively lower viscosity among the first and second components.
  • Another aspect of the present invention is a two-component catheter device wherein said pressure regulating valve comprises a cone knob and a corresponding recess, wherein said cone knob is adapted to adjust the flow cross-sectional area of the pressurized channel by advancing or retracting said cone knob.
  • Another aspect of the present invention is a two-component catheter device further comprising a catheter having at least two separate lumens formed therein, wherein the separated lumens have different diameters or different cross-sectional areas.
  • Another aspect of the present invention is a two-component catheter injection device, wherein the compressed gas discharge unit includes a compressed gas container, and a trigger switch for releasing the compressed gas from the compressed gas container to the first connection portion.
  • the compressed gas discharge unit includes a compressed gas container, and a trigger switch for releasing the compressed gas from the compressed gas container to the first connection portion.
  • Another aspect of the present invention further includes a second trigger button configured to be able to press the trigger switch, and compressed gas is released only when the trigger button is in a pressed state of the trigger switch, depending on the degree to which the trigger button is pressed It is a two-component catheter injection device including a press interval adjusting unit that allows the amount of compressed gas to be adjusted.
  • Another aspect of the present invention is an injection method for ejecting a substance through a catheter having at least two separate lumens formed therein, comprising the steps of: triggering a compressed gas discharge unit; pressing the first component and the second component separately stored in the discharge storage unit through the first component and the second component are respectively introduced into the separate lumen of the catheter through the second connection unit and the distal end of the catheter It is a two-component catheter injection method comprising the step of being injected in.
  • Another aspect of the present invention is a two-component catheter injection method further comprising releasing the increased pressure when the distal end of the catheter or the inside of the lumen is occluded.
  • the first connection portion includes first and second pressurized channels for delivering compressed gas to the first and second components, respectively, and any one of the first pressurized channel and the second pressurized channel It is a two-component catheter injection method further comprising the step of adjusting the above flow rate.
  • the flow control step is a two-component catheter injection method configured to control the flow rate of a pressurized channel communicating with a material having a lower viscosity among the first and second components.
  • Another aspect of the present invention is a two-component catheter injection method, wherein the flow control step is achieved by varying the size of the diameter or cross-sectional area of the separated lumens.
  • two or more components including a liquid may be injected into the hemostatic site in the gastrointestinal tract.
  • two or more components having different viscosities can be uniformly sprayed onto the hemostatic site in the gastrointestinal tract.
  • the wound dressing injection device and method of the present invention it is possible to prevent curing due to an early reaction between two or more components.
  • the mixing process between the components can be started when two or more components are injected from the separated lumens of the catheter to the bleeding site.
  • the increased pressure due to the clogging of the catheter tube can be relieved. Therefore, safe treatment is possible.
  • 1 is a wound dressing injection device according to the prior art.
  • Figure 2 is a perspective view of a wound dressing injection device according to an embodiment of the present invention, (a) is a plan view, (b) is a side perspective view.
  • Figure 3 is a partial exploded view of the wound dressing injection device according to another embodiment of the present invention, (a) is a plane, (b) is a side view.
  • FIG. 4 is a side perspective view of a pressure release valve according to an embodiment of the present invention.
  • Figure 5 shows a wound covering material injection device according to another embodiment of the present invention.
  • FIG. 6 is a partially enlarged view of the embodiment of FIG. 5 .
  • FIG. 7 is a conceptual diagram of a pressure control valve according to an embodiment of the present invention.
  • FIG. 8 is a cross-sectional view of a catheter according to embodiments of the present invention.
  • FIG. 9 is a view showing a press interval adjusting unit according to an embodiment of the present invention.
  • Figure 2 is a perspective view showing the wound dressing injection device 10 according to an embodiment of the present invention.
  • a container 19 filled with compressed gas and a compressed gas discharge unit 11 including a trigger switch 13 are disposed at the right end of the casing 27 .
  • the compressed gas may be a CO 2 gas.
  • the compressed gas container 19 is detachable and configured to be replaced when the gas is exhausted.
  • the cartridge 20 in which the component to be discharged is stored is fixed to the mount head 25 by a fixing ring 23 .
  • the cartridge 20 includes two separate canisters 21a and 21b, and each canister contains a component to be sprayed on the bleeding site in the gastrointestinal tract.
  • These ingredients may be liquid ingredients.
  • one component may be a hemostatic component and the other component may be a component that gels when mixed with the hemostatic component and promotes adhesion to a bleeding site.
  • the two components may have different viscosities.
  • the cartridge is configured to be replaceable by simply removing it.
  • a flow path through which the compressed gas can flow is formed between the compressed gas discharge unit 11 and the discharge component cartridge 20 .
  • This passage may be formed by a combination of various parts including the connectors 15a to 15e and the connector 17 .
  • a pressure release valve 30 is coupled to the connecting tube 17 . (Elements located in pairs on the back side of the drawing are indicated in parentheses, such as '15b(c)' or '15d(e)'. Same throughout this specification)
  • the injection device 10 is connected to the catheter 3 .
  • a flow path is formed between the catheter 3 and the ejection component cartridge 20 to communicate with each other.
  • This passage may be formed by a combination of various parts including the connectors 15f to 15i and the mount adapter 18 .
  • the passageways in the mount adapter 18 are formed so that components stored separately in the cartridge 20 can each be introduced into the separate lumens of the catheter 3 without mixing in the adapter 18 .
  • Figure 3 is a partial exploded view of the wound dressing injection device according to another embodiment of the present invention. This embodiment is the same as the embodiment shown in FIG. 2 except that the mount adapter 18' connected to the catheter 3 has a different shape.
  • the mount adapter 18' has a plurality of passages formed therein to enable connection in various directions. When an appropriate path is selected among them, the remaining paths may be blocked using an adhesive or the like.
  • the flow paths 14a and 14b between the compressed gas discharge unit 11 and the discharge component cartridge 20 are indicated by lines.
  • the flow path 14a allows the compressed gas to flow into the canister 21a
  • the flow path 14b allows the compressed gas to flow into the canister 21b.
  • Compressed gas may be introduced through a thin tube extending into the canisters 21a and 21b, whereby the pressurized discharge components are introduced into the flow paths 14a and 14b through an outlet gap formed at the upper end of the canisters 21a and 21b.
  • flow paths 16a and 16b between the ejection component cartridge 20 and the catheter are indicated by lines.
  • the flow path 16a connects the canister 21a in the cartridge 20 and the connector 15h coupled to the mount adapter 18', and the flow path 16b connects the canister 21b and the connector 15i. do.
  • Components introduced through each flow path 16a, 16b from each of the canisters 21a and 21b separated from each other are maintained without being mixed with each other until the separated lumens of the catheter 3 through the mount adapter 18'.
  • the two components are a hemostatic component and a gelling component, respectively, it is prevented that the two components are mixed at an early time before reaching the hemostatic site by the above structure.
  • the pressure release valve 30 includes an upper cover 31 and a lower cover 33 , and further includes a release valve cartridge 35 therein.
  • the catheter distal end may come into contact with tissue and be blocked by tissue fragments, blood clots, or the like. In this case, there is a risk that the pressure inside the injection device increases rapidly and, as a result, the procedure fails due to device failure.
  • the lower cover 33 or tightening lever 37 of the release valve 30 when the internal pressure of the injector 10 exceeds a preset pressure (eg, 250 psi). is configured to release the pressure by being released.
  • the release valve cartridge 35 is replaceable according to the required set pressure.
  • Figure 5 shows a wound covering material injection device according to another embodiment of the present invention.
  • the flow rate of the compressed gas flowing into one flow path 14a can be adjusted by using the cone knob 41 shown in FIG. 5 .
  • the cone knob 41 is mounted into the passage of the connecting pipe 40 for branching the compressed gas into both passages 14a and 14b. Due to the addition of the connector 40 in this embodiment, additional connectors 15b-1 and 15c-1 are installed.
  • the compressed gas passing through the connector 15b passes through the common connecting pipe 30 until it is branched by the connecting pipe 40 .
  • FIG. 6 is an enlarged view of the peripheral configuration of the cone knob 41 .
  • the cone knob 41 includes a head 43 , a shaft portion 44 , and a cone portion 46 , and a thread 45 may be formed around the shaft portion 44 .
  • a recess 47 complementary to the shape of the cone 46 of the cone knob 41 is formed in the connecting tube 40 .
  • the pressure regulating valve is provided by the peripheral components including the cone knob 41 and the recess 47 . If it is scaled here, it may be more advantageous to use. This optimizes the setup and resulting gas flow rates, allowing easy adjustments for discharge components of different viscosities requiring different flow rates.
  • FIG. 7 is a conceptual diagram illustrating a pressure control valve according to an embodiment of the present invention.
  • the cone knob 41 When the cone knob 41 is rotated in the rotational direction 42, the passage communicating with the passage 14a can be narrowed, while the cross-sectional area of the passage communicating with the remaining passage 14b is not affected.
  • the relative viscosity is The discharge flow rate of components with low relative viscosity can be reduced to a desired level without changing the discharge flow rate of high components.
  • an appropriate discharge amount can be adjusted by adjusting the flow rate using the cone knob 41 . By doing so, an optimal blending of the two components discharged from the catheter end can be achieved.
  • FIG. 8 is a cross-sectional view of a catheter according to embodiments of the present invention.
  • Figure 8 (a) is a catheter (3') having four lumens (50a to 50d), two lumens (50a, 50b) for discharging the component, the other two (50c, 50d) for wire insertion Can be used. If the lumens for wire insertion are omitted, a catheter 3'' (see FIG. 8(b)) with an increased diameter or cross-sectional area of the discharge lumens 50a, 50b is obtained, or a reduced thickness catheter 3''' ) (see Fig. 8(c)) can be obtained.
  • the flow rate of each component may be adjusted by variously configuring the diameter or cross-sectional area of the lumens 50a and 50b.
  • the diameter can be adjusted according to the difference in viscosity of both discharge components, and the higher the viscosity, the larger the lumen can be to reduce the applied pressure.
  • FIG 9 shows a press gap adjusting mechanism according to an embodiment of the present invention.
  • the trigger switch 13 is configured so that the amount of compressed gas emitted varies according to the degree to which it is pressed (the more it is pressed, the greater the amount is emitted), and when the hand is released, it is deactivated again, that is, it is configured to return to a non-emission state.
  • the press button 60 is installed through the support 55 , and when the head 61 is pressed, the contact end 65 presses the trigger switch 13 .
  • the maximum interval at which the head 61 of the press button 60 can be pressed is indicated by 'd'. 'd' can be adjusted by moving the spacing adjusting unit 67 away from or closer to the head 61 by rotation or the like. In this way, it becomes possible to control the release amount of the compressed gas.
  • the compressed gas contained in the container 19 is released and reaches the cartridge 20.
  • the compressed gas is branched and the two canisters 21a and 21b in the cartridge 20) are each introduced into
  • the flow rates of the respective passages 14a and 14b for fluidly communicating the compressed gas to the respective canisters 21a and 21b may be adjusted by the pressure control valves 41 and 47 in combination.
  • each canister (21a, 21b) When the compressed gas is introduced, the components in each canister (21a, 21b) are introduced into the separated lumens (50a, 50b) of the catheter (3) in an isolated state through the flow passages (16a, 16b) to the affected part through the catheter end is sprayed That is, the separation of the two components is maintained in all paths from the canisters 21a and 21b to the distal end of the catheter.
  • the mixing process of each of the canisters 21a and 21b and the components that were separated on the delivery path begins at the distal end of the insertion catheter as it is injected from the separated lumens of the catheter into the bleeding site.

Abstract

L'objectif de la présente invention est de fournir un dispositif et un procédé de pulvérisation de matériau de pansement, qui peut pulvériser au moins deux substances sur une zone, dans le tractus gastro-intestinal, où un saignement doit être arrêté. L'invention concerne un dispositif de pulvérisation à cathéter à deux composants pour pulvériser une substance par l'intermédiaire d'un cathéter ayant au moins deux lumières séparées, le dispositif comprenant : une partie d'évacuation de gaz comprimé ; une partie de stockage de substance de décharge comportant une première partie de stockage pour stocker une première substance, et une seconde partie de stockage pour stocker une seconde substance ; une première partie de raccordement pour relier la partie de décharge de gaz comprimé et la partie de stockage de substance de décharge ; et une seconde partie de raccordement pour relier la partie de stockage de substance de décharge et le cathéter.
PCT/KR2021/000506 2021-01-13 2021-01-13 Dispositif de pulvérisation de matériau de pansement pour ulcère gastroduodénal WO2022154138A1 (fr)

Priority Applications (1)

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PCT/KR2021/000506 WO2022154138A1 (fr) 2021-01-13 2021-01-13 Dispositif de pulvérisation de matériau de pansement pour ulcère gastroduodénal

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PCT/KR2021/000506 WO2022154138A1 (fr) 2021-01-13 2021-01-13 Dispositif de pulvérisation de matériau de pansement pour ulcère gastroduodénal

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003000713A (ja) * 2001-06-21 2003-01-07 Nippon Clean Engine Lab Co Ltd 液体噴射手術方法とその装置
KR20150004832A (ko) * 2012-04-23 2015-01-13 키에시 파르마슈티시 엣스. 피. 에이. 분무화에 의한 폐계면활성제의 투여를 위한 방법 및 시스템
US20150173821A1 (en) * 2007-02-27 2015-06-25 Regents Of The Universtiy Of Minnesota Thermochemical ablation of bodily tissue
KR20160105829A (ko) * 2013-12-31 2016-09-07 쿡 리젠틱, 엘엘씨 보강 외부 풍선 밸브를 구비한 생물학적 치료제용 주입 카테터 팁
KR20190035682A (ko) * 2016-07-28 2019-04-03 키에시 파르마슈티시 엣스. 피. 에이. 에어로졸화된 약제의 전달을 위한 방법 및 시스템

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003000713A (ja) * 2001-06-21 2003-01-07 Nippon Clean Engine Lab Co Ltd 液体噴射手術方法とその装置
US20150173821A1 (en) * 2007-02-27 2015-06-25 Regents Of The Universtiy Of Minnesota Thermochemical ablation of bodily tissue
KR20150004832A (ko) * 2012-04-23 2015-01-13 키에시 파르마슈티시 엣스. 피. 에이. 분무화에 의한 폐계면활성제의 투여를 위한 방법 및 시스템
KR20160105829A (ko) * 2013-12-31 2016-09-07 쿡 리젠틱, 엘엘씨 보강 외부 풍선 밸브를 구비한 생물학적 치료제용 주입 카테터 팁
KR20190035682A (ko) * 2016-07-28 2019-04-03 키에시 파르마슈티시 엣스. 피. 에이. 에어로졸화된 약제의 전달을 위한 방법 및 시스템

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