[go: up one dir, main page]

WO2024047387A1 - Appareil de cathétérisme rapide pour l'application d'une pression et d'un écoulement dans le système cardio-vasculaire, applicable à la réanimation et à d'autres procédures médicales - Google Patents

Appareil de cathétérisme rapide pour l'application d'une pression et d'un écoulement dans le système cardio-vasculaire, applicable à la réanimation et à d'autres procédures médicales Download PDF

Info

Publication number
WO2024047387A1
WO2024047387A1 PCT/IB2022/058298 IB2022058298W WO2024047387A1 WO 2024047387 A1 WO2024047387 A1 WO 2024047387A1 IB 2022058298 W IB2022058298 W IB 2022058298W WO 2024047387 A1 WO2024047387 A1 WO 2024047387A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
blood
sealing
blood vessel
tube
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/IB2022/058298
Other languages
English (en)
Inventor
Hamid KAREVAN
Sara KAREVAN
Negar KAREVAN
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to PCT/IB2022/058298 priority Critical patent/WO2024047387A1/fr
Publication of WO2024047387A1 publication Critical patent/WO2024047387A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
    • A61M60/113—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems in other functional devices, e.g. dialysers or heart-lung machines
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/36—Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
    • A61M60/38—Blood oxygenation
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0258—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body for vascular access, e.g. blood stream access
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
    • A61M2039/0297—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body at least part of it being inflatable, e.g. for anchoring, sealing or removing
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/90—Details not provided for in groups A61M60/40, A61M60/50 or A61M60/80

Definitions

  • the present invention relates to apparatus and method which makes it possible to rapidly connect blood pumps and more specifically heart-lung machines to the cardio-vascular system.
  • Electrodialysis, extracorporeal life support (ECLS) or extracorporeal membrane oxygenation (ECMO) are examples of such devices.
  • ECMO for instance, is being used to help or bypass cardiopulmonary functions. It can temporarily act as heart or lung or both.
  • the main application of such machines includes helping the transplantation procedure or as an emergency assist in cardiac arrest or failure followed by coronary artery malfunctions.
  • NPL1, NPL2, NPL3 extracorporeal cardiopulmonary resuscitation (ECPR) and the results proved that it is applicable and effective to use artificial heart-lung machine in the procedure of resuscitation.
  • resuscitative endovascular balloon occlusion of the aorta is one way to be used in rapid connection of ECMO to the patient’s body (NPL4), it needs other devices to determine the probe's position and might not be suitable for emergency situations.
  • Methods and devices like those mentioned in PTL1, PTL2, and PTL3 are previously invented ways to seal punctures and body hole cavities to enter a catheter into the body.
  • PTL4 and PTL5 to act as vascular closure
  • PTL6 to effect closure of a perforation in the septum of the heart
  • PTL7 to arteriotomy closure
  • PTL8 for closure of openings in a tissue wall.
  • none of them used the method to connect a catheter to vessels in order to apply pressure or establish flow into the cardiovascular system.
  • ECPR is available, that is, if the resuscitation team has a device to quickly connect the cardio-vascular system to heart-lung machines, ECMO (NPL1) for instance, the patient could be saved until the heart is cured or transplanted.
  • a quick cannulation device is introduced, which is capable of rapidly being connected to vessels without getting loose or unsealed during applying pressure that is needed to circulate blood in the whole or part of cardio-vascular system.
  • devices and methods are presented which provide the ability of rapid cannulation to the veins or arteries.
  • Two embodiments of such devices are presented hereby which use balloon swelling to seal the incision of blood tubes.
  • 1' Blood vessel’s wall; 2': Ring-shaped-balloons (before swelling); 3': Blood tube; 5': Needle; 6': Stop ring; 9': Fixed fluid tubes; 10': Flexible fluid tubes which connects fixed fluid tubes (9’) to the pressurizing/depressurizing device(s).
  • Two embodiments for making a pressure-tolerable-canulation are shown in and [ ⁇ .
  • the main idea of sealing the canulation is to add a sealing element (2 and 2’), also known as “ring-shaped-balloons" in this patent, on each side of blood vessel’s wall (1 and 1’) at the point of cannulation's hole which is already made by the needle (5 and 5’).
  • one sealing element is inside the blood vessel adjacent and tangential to the hole made by the needle and the other is outside of the blood vessel and adjacent and tangential to the hole.
  • Being flexible in shape is essential for the sealant during needle’s penetration because it is needed for the penetration’s hole to have a diameter equal to that of the needle which is not possible if the sealants have considerable volume. Therefore, the sealants' volumes are negligible at the time of penetration and would be large enough after penetration to seal the perforation when it is needed.
  • the sealants’ volume can be increased by a pressurized fluid like air, water, etc.
  • the swelling of the sealant will be continued until sealing of the puncture point is achieved by enough force created between inner and outer sealants while the blood vessel’s wall is between them.
  • the sealing will be omitted by depressurizing the fluid inside the flexible sealant.
  • the flexible sealants (2 and 2’) are made of closed elastic membranes at the end of fluid tubes (9 and 9'). The sealing is done by swelling of the membranes.
  • the membranes After swelling, the membranes would have a 3-dimentional shape like sphere, cylinder, hemi-sphere, torus, cone, ellipsoid, or any other 3-dimension shapes that is able to make the puncture sealed by applying force to the other sealant while the blood vessel’s wall is between the two sealants.
  • the fluid tubes are aimed to pressurize/depressurize the membrane.
  • the fluid tube’s material can be of metal, polymer, etc. In the first embodiment the fluid tube could pass from the inner or outer side of the needle. If the fluid tube passes inside the needle, one or two holes on the needle’s wall are needed for the fluid tube(s) to be connected to the membranes through the needle’s wall.
  • the fluid tube could pass from the inner or outer side of the blood tube. If the fluid tube passes inside the blood tube, one or two holes on the blood tube's wall are needed for the fluid tube(s) to be connected to the membranes through the needle’s wall.
  • the fluid tubes connect the membranes to pressurizing/depressurizing devices.
  • Pressurizing/depressurizing devices include valves, vacuum, pumps or chambers, accumulators, etc.
  • the pressurizing /depressurizing procedure could be performed abruptly, or gradually.
  • the first embodiment of fast cannulation is fixing the needle at the puncture point to the blood vessel as shown in .
  • the ring-shaped-balloons (2’) are permanently connected to the needle (5’).
  • there are fixed fluid tubes (9’) inside the needle (5’) which connect these fluid tubes to the flexible fluid tubes (10’) that connects fixed fluid tubes (9’) to the pressurizing/depressurizing devices.
  • a blood tube (3’) also connects the needle (5’) to the blood pumping machine, i.e., artificial heart lung machine.
  • a stop ring (6’) could be optionally included in the outer ring perimeter of the needle (5’) so that the operator can visually or tactilely sense reaching of the needle to its proper position like .
  • the needle In order to prevent having a needle constantly connected to the blood vessel, in this embodiment the needle could be pulled back from the patient's body. Hence, in this embodiment the needle is considered as a removable media and could be taken back from the blood vessel cannulation point, after the sealing is made.
  • the needle (5) is the carrier of the sealing device until the sealing is performed and then the needle would leave the sealant.
  • the sealants (2) are attached to the blood tube (3) whereas sealants (2') were attached to the needle in the first embodiment ( ).
  • the second-embodiment's needle is considered as separable.
  • the needle For utilizing the second embodiment, at first, carrying needle (5) penetrates into the soft tissues and blood vessel (1).
  • the needle must penetrate enough to be situated in the proper place at where the stop ring (6) touches the outer side of the vessel. At this position, the inner sealant is inside the blood vessel and the outer sealant is outside of the blood vessel as shown in .
  • the needle is controlled by the operator’s hand while the blood tube (3) which is flexible and includes the sealing elements (2) is placed inside the needle; the needle (5) and the blood tube (3) are temporarily fixed together by a locking element (8) which is grasping an appendix (4) through the force of a spring (7).
  • the locking element mentioned also could be controlled by the operator or any kind of manual or automatic actuators.
  • This element is to keep the needle and the blood tube attached together, until it is needed to separate them to take the needle back and out of the blood vessel.
  • This element can be a mechanical screw or clamp or done by magnetic force of a magnet and an iron part or any other ways which can keep two parts together temporarily.
  • the needle (3) could contain a stop ring (6) that helps the operator to sense the blood vessel’s wall visually or tactilely when it reaches its proposed position. shows that at this stage, the operator releases the locking element (8) to separate it from the appendix (4) on the blood tube (3) and then pulls the needle (5) back out of the patient's body.
  • the pressurized sealants are swelled one by one as shown in to , and would be increased in volume by receiving pressure from any fluid carried by the fluid tubes (9). It is also possible to connect both sealants (ring-shaped-balloons) to one fluid tube as shown in . When both sealants get free from surrounded needle the sealing is done by their interactive force applying to each other and the blood vessel’s wall between them.
  • the blood tube is connected sealed and fixed to the blood vessel. At this point the operator can release the blood tube (3) which already maintained by hand to keep its position. Thereafter, the blood pump or heart-lung machines connected to the blood tube can be started.
  • the sealing and the accessories could be omitted by depressurizing the ring-shaped-balloons and the needle or the blood tube and everything could be pulled out and disconnected from the blood vessel and patient’s body.
  • the current invention can be used widely in medical and surgical centers, as well as, emergency services.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

Des machines cœur-poumon classiques ont été utilisées afin de faire circuler le sang en cas d'absence, de dysfonctionnement ou d'anomalie du cœur et/ou du poumon. La connexion de ces dispositifs nécessite toutefois des procédures chirurgicales chronophages, ce qui rend leur utilisation difficile dans le cadre de l'ECPR. Par le procédé décrit dans la présente invention, il est possible de connecter rapidement des machines cardiaques extracorporelles aux vaisseaux sanguins principaux, en particulier quand il est à peine possible de le faire par simple pénétration à partir de la peau sans avoir besoin de coupes chirurgicales dans la mesure où l'opérateur est suffisamment professionnel. La présente invention permet de connecter rapidement des machines cœur-poumon à un patient en arrêt cardiaque considéré comme décédé. Par conséquent, il y aurait le temps nécessaire à une guérison ou à une transplantation cardiaque une fois le patient revenu à la vie. La présente invention présente également l'avantage de pouvoir être utilisée dans le cadre de la transplantation d'organes lorsqu'une connexion rapide entre les vaisseaux et les tubes extracorporels est essentielle.
PCT/IB2022/058298 2022-09-03 2022-09-03 Appareil de cathétérisme rapide pour l'application d'une pression et d'un écoulement dans le système cardio-vasculaire, applicable à la réanimation et à d'autres procédures médicales Ceased WO2024047387A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2022/058298 WO2024047387A1 (fr) 2022-09-03 2022-09-03 Appareil de cathétérisme rapide pour l'application d'une pression et d'un écoulement dans le système cardio-vasculaire, applicable à la réanimation et à d'autres procédures médicales

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2022/058298 WO2024047387A1 (fr) 2022-09-03 2022-09-03 Appareil de cathétérisme rapide pour l'application d'une pression et d'un écoulement dans le système cardio-vasculaire, applicable à la réanimation et à d'autres procédures médicales

Publications (1)

Publication Number Publication Date
WO2024047387A1 true WO2024047387A1 (fr) 2024-03-07

Family

ID=90098847

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2022/058298 Ceased WO2024047387A1 (fr) 2022-09-03 2022-09-03 Appareil de cathétérisme rapide pour l'application d'une pression et d'un écoulement dans le système cardio-vasculaire, applicable à la réanimation et à d'autres procédures médicales

Country Status (1)

Country Link
WO (1) WO2024047387A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6371943B1 (en) * 1997-09-08 2002-04-16 Epimed International, Inc. Spring tip needle combination
US20080269718A1 (en) * 1998-05-21 2008-10-30 The Government Of The Usa As Represented By The Sec Of The Dept. Of Health & Human Services Method for pressure mediated selective delivery of therapeutic substances and cannula
US20090054805A1 (en) * 2005-07-26 2009-02-26 Precision Thoracic Corporation Minimally invasive methods and apparatus

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6371943B1 (en) * 1997-09-08 2002-04-16 Epimed International, Inc. Spring tip needle combination
US20080269718A1 (en) * 1998-05-21 2008-10-30 The Government Of The Usa As Represented By The Sec Of The Dept. Of Health & Human Services Method for pressure mediated selective delivery of therapeutic substances and cannula
US20090054805A1 (en) * 2005-07-26 2009-02-26 Precision Thoracic Corporation Minimally invasive methods and apparatus

Similar Documents

Publication Publication Date Title
US7025741B2 (en) Arteriovenous access valve system and process
US6210365B1 (en) Perfusion catheter system having sutureless arteriotomy seal and methods of use
US5562617A (en) Implantable vascular device
US20240325617A1 (en) Self-sealing cannula
US9078982B2 (en) Systems, methods and devices for circulatory access
US8419672B2 (en) Peripheral access devices and systems
US11324870B2 (en) Arteriovenous access valve system and process
DK2358413T3 (en) PULSING MEDICAL DEVICE FOR USE IN EXTRASPORAL SURGERY
JPH06277278A (ja) 灌流カニューレ並びにそれに使用するガードルおよびトロカール
JP2009172273A (ja) 血流遮断カテーテル
WO2012123366A1 (fr) Procédé thérapeutique et chirurgical d'assistance respiratoire
US9821108B2 (en) Arteriovenous access valve system and process
US20240009438A1 (en) Devices and methods for fistula-free hemodialysis
KR101671612B1 (ko) 장기 적출 수술용 복강 내 장기관류장치
WO2024047387A1 (fr) Appareil de cathétérisme rapide pour l'application d'une pression et d'un écoulement dans le système cardio-vasculaire, applicable à la réanimation et à d'autres procédures médicales
CN110638557B (zh) 一种四分支人工血管组件
CN211023312U (zh) 一种用于主动脉手术的人工血管组件
US20210386431A1 (en) Endovascular, rapid-access, balloon catheter for treatment of pulmonary embolism
CN110638558A (zh) 一种医用半开放式阻断装置
GB2432324A (en) Arteriovenous Access Valve System and Process

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22956687

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 22956687

Country of ref document: EP

Kind code of ref document: A1