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WO2022139771A1 - Canule ecmo (oxygénation de membrane extracorporelle) veino-veineuse à lumière unique - Google Patents

Canule ecmo (oxygénation de membrane extracorporelle) veino-veineuse à lumière unique Download PDF

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Publication number
WO2022139771A1
WO2022139771A1 PCT/TR2021/051492 TR2021051492W WO2022139771A1 WO 2022139771 A1 WO2022139771 A1 WO 2022139771A1 TR 2021051492 W TR2021051492 W TR 2021051492W WO 2022139771 A1 WO2022139771 A1 WO 2022139771A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
ecmo
single lumen
present
inflow
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/TR2021/051492
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English (en)
Inventor
Yahya YILDIZ
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.)
Istanbul Medipol Universitesi
Original Assignee
Istanbul Medipol Universitesi
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 Istanbul Medipol Universitesi filed Critical Istanbul Medipol Universitesi
Publication of WO2022139771A1 publication Critical patent/WO2022139771A1/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
    • 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
    • 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
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines

Definitions

  • the present invention relates to a single-inflow, single lumen, multiple-outflow cannula for venovenous ECMO (Extracorporeal Membrane Oxygenation).
  • Extracorporeal membrane oxygenation is an extracorporeal life support method employed in patients of all age groups who suffer from heart, circulatory, and/or respiratory failure and do not respond to conventional treatment methods.
  • the ECMO system incorporates drawing venous (outflow) blood from a patient's body by using cannula or cannulae and infusing arterial (inflow) blood back into the patient's body after venous blood is subjected to gas exchange and oxygenation.
  • the cannulae used for venovenous ECMO in pediatric age groups may suffer performance issues stemming from the insufficiency of blood drawing and blood infusion capacities. Overcoming this issue requires using larger cannulae according to patients' sizes. While insertion problems are experienced accordingly, the administration imposes a risk of causing further injury in a patient's heart, vessels and organs in close proximity. Moreover, an echocardiography device is utilized with the aim of confirming that the cannulae inserted with difficulty are indeed properly positioned, and the use of this device requires distinct experience.
  • ECMO cannulae may generally be placed through venovenous (vv), venoarterial (va), or venovenoarterial (vva) routes, or placement thereof may be performed in various ways and types apart from those named above.
  • the administration of ECMO cannulae may be peripheral or central.
  • Peripheral ECMO may be performed via the cannulation of Internal Jugular Vein (IJV) and Femoral Vein/artery and arteries.
  • Peripheral vv ECMO may be carried out through the cannulation of IJV and Femoral Vein.
  • Peripheral va/wa ECMO may be performed via the cannulation of IJV and Femoral Vein/artery.
  • peripheral vv ECMO may be performed through two vessels, namely, two veins by using two cannulae, it may also be carried out by means of a single cannula with double lumen through the IJV.
  • Central ECMO is an ECMO application performed through the right atrium of the heart, and the aorta.
  • a characteristic of the cannula used for vv ECMO nowadays and placed through the IJV is that this cannula comprises a tip orifice, and at distal part of this orifice, a plurality of holes that are located in a manner distributed around the cannula. Blood cleansed in the ECMO machine is transferred to the right atrium of a patient through these holes. During the transfer process, blood, which exits the tip of the cannula, and is sent to the right atrium via injection, is directed towards the cannula, which is located in the inferior vena cava, and receives blood, thereby performing recirculation. This recirculation leads to a redundant circulation of blood inside the machine, to working of the blood unnecessarily, and ultimately to undesired blood damage.
  • the central venous pressure (CVP) measured from the superior vena cava may be high because of the fact that the cannulae used in the state of the art comprises 4 holes located on 4 sides of a cannula.
  • CVP central venous pressure
  • High CVB may lead to swelling in hands (upper extremity) followed by cerebral edema or an increase in intracranial pressure, thereby leading to brain damage (cerebral deficit).
  • an increased amount of short circuit, namely, a recirculation is inevitable in this design, which in turn, corresponds to an underperforming cannula.
  • the same design also lacks a fixing element. Therefore, the maintenance of cannula's position is under constant risk.
  • This cannula design further lacks an indicator component that shows the position of the cannula; therefore, a special imaging experience (Echocardiogram/ultrasound) is required in order to ensure that the cannula is positioned properly.
  • the present invention relates to a single lumen venovenous ECMO cannula (A).
  • the single lumen venovenous ECMO cannula (A) comprises; a horizontally beveled inflow proximal orifice (101), at least one inflow flowdiverting hole (102), a midline (103), a serrated section (104), single lumen cannula body (105), and an internal-external line (106).
  • the fact that the proximal orifice (101) has a horizontally beveled shape and that the body (105) comprises a plurality of diverting holes thereon reduce the blood trauma induced by the use of an ECMO cannula, thereby broadening the range of application of the cannula. Moreover, since the blood flow is diverted to the tricuspid valve by means of the cannula according to the present invention, the incidence of recirculation (short circuit) present in ECMO cannulae available in the state of the art is reduced or eliminated completely.
  • Figure 1 illustrates the front view of the single lumen venovenous ECMO cannula (A) according to the present invention.
  • Figure 2 illustrates the side view of the single lumen venovenous ECMO cannula (A) according to the present invention.
  • the present invention relates to a single lumen venovenous ECMO cannula (A) comprising; a horizontally beveled inflow proximal orifice (101), at least one inflow flowdiverting hole (102), a midline (103), a serrated section (104), a single lumen cannula body (105), and an internal-external line (106).
  • A single lumen venovenous ECMO cannula
  • A comprising; a horizontally beveled inflow proximal orifice (101), at least one inflow flowdiverting hole (102), a midline (103), a serrated section (104), a single lumen cannula body (105), and an internal-external line (106).
  • the ECMO cannula according to the present invention comprises 1-5 inflow flowdiverting holes (102).
  • the proximal end (101) of the cannula (A) according to the present invention is provided with a radio-opaque marker.
  • Body (105) of the cannula according to the present invention may have an elliptical/circular shape.
  • the infusion canal of the body (105) of the cannula according to the present invention is not flexible. Thus, it is ensured that the lumen diameter does not vary depending on the drawing-infusion force in the cannula (A), thereby providing a stable flow.
  • the cannula according to the present invention is further provided with a reverse dowel/micro-serrated element (104), which is a special component providing resistance against potential infections.
  • the cannula according to the present invention comprises a marker (106) that indicates the intracardiac and intravenous position of the cannula. This marker indicates both the level of the cannula and the direction of the orifice transfusing the blood.
  • the cannula (A) according to the present invention is positioned inside the superior vena cava and employed for returning, i.e., the inflow of cleansed blood to the patient.
  • the proximal orifice (101) in the cannula (A) is designed to feature an inwardly-beveled shape instead of a flat bevel so as to divert blood to the valve (tricuspid valve).
  • proximal orifice (101) of the cannula (A) At the distal portion (upper portion) of the proximal orifice (101) of the cannula (A) according to the present invention is provided 1-5 oval/ellipsoid inflow flow-diverting holes (102) positioned at 1-2 cm intervals such that they are aligned with one another. These holes (102) divert the flow inwards, namely, into the AV valve, that is, to the tricuspid valve, to the right ventricle.
  • a preferred embodiment of the present invention comprises 2-5 inflow flow-diverting holes (102).
  • the cannula is provided with a midline marker so that the cannula may be positioned properly.
  • the distal portion of the cannula is further provided with intemal/extemal markers that indicate the inside and outside of the cannula.
  • the body (105) of the cannula according to the present invention may be completely reinforced with metal in a spiral pattern (surrounding), this structure may also be available only on certain parts of the cannula, for instance, the percutaneous insertion point of the cannula.
  • the micro- serrated element (104) included in the ECMO cannula (A) according to the present invention is composed of serrations (104). These serrations (104) are positioned towards the distal end of the body (105) of the cannula. In other words, the serrations provided on the micro- serrated element (104) included in the cannula (A) according to the present invention are positioned on the body (105) of the cannula such that they form an angle in a range between 1° and 175° relative to the body of the cannula.
  • the angle between serrations and the body (105) of the cannula may be, for example; 5 °, 10 °, 15 °, 20 °, 25 °, 30 °, 35 °, 40 °, 45 °, 50 °, 55 °, 60 °, 65 °, 70 °, 75 °, 80 °, 85 °, 90 °, 100 °, 110 °, 120 °, 130 °, 140 °, 150 °, 160 °, 170 °.
  • the aim of the micro-serrated element (104) provided on the cannula (A) according to the present invention is to create a barrier against percutaneous entry of bacteria and microorganisms.
  • the cannulae according to the present invention may be manufactured from metallic or polymeric materials available in the state of the art such as chlorine hexidine, potassium iodide, alcohol, etc., that are not affected by disinfectants, that are inert to these disinfectants, and that do not interact with these disinfectants.
  • the cannula (A) according to the present invention may be manufactured in various types and sizes, and for every age, height, and weight so as to accommodate the characteristics of human anatomy of different sizes, for example, neonatal, pediatric, and adult patients.
  • Embodiments of the present invention may be combined where appropriate in the technique.
  • Patent documents and applications, and particularly the patent applications numbered TR 2018/20410, TR 2018/201413, TR 2018/20419, and similar technical references are included in this document through citations.
  • Embodiments disclosed specifically and explicitly in the description provided herein may solely or in combination with one or more than one embodiments serve as a basis for a disclaimer.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne une canule à entrée unique, à lumière unique et à écoulement multiple destinée à une ECMO (oxygénation de membrane extracorporelle) veino-veineuse.
PCT/TR2021/051492 2020-12-24 2021-12-24 Canule ecmo (oxygénation de membrane extracorporelle) veino-veineuse à lumière unique Ceased WO2022139771A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2020/21534A TR202021534A1 (tr) 2020-12-24 2020-12-24 Tek lümenli̇ venovenöz ekmo (ekstrakorporeal membran oksi̇jenasyonu) kanül
TR2020/21534 2020-12-24

Publications (1)

Publication Number Publication Date
WO2022139771A1 true WO2022139771A1 (fr) 2022-06-30

Family

ID=82158338

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2021/051492 Ceased WO2022139771A1 (fr) 2020-12-24 2021-12-24 Canule ecmo (oxygénation de membrane extracorporelle) veino-veineuse à lumière unique

Country Status (2)

Country Link
TR (1) TR202021534A1 (fr)
WO (1) WO2022139771A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5643215A (en) * 1995-02-24 1997-07-01 The Research Foundation Of State University Of New York Gas exchange apparatus and method
US20050085761A1 (en) * 2003-08-25 2005-04-21 Dongfang Wang Single expandable double lumen cannula assembly for veno-venous ECMO
US20170303958A1 (en) * 2014-11-14 2017-10-26 University Of Maryland, Baltimore Self-sealing cannula
WO2018013644A1 (fr) * 2016-07-12 2018-01-18 3R International Co., Ltd. Système de support de vie extracorporel

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5643215A (en) * 1995-02-24 1997-07-01 The Research Foundation Of State University Of New York Gas exchange apparatus and method
US20050085761A1 (en) * 2003-08-25 2005-04-21 Dongfang Wang Single expandable double lumen cannula assembly for veno-venous ECMO
US20170303958A1 (en) * 2014-11-14 2017-10-26 University Of Maryland, Baltimore Self-sealing cannula
WO2018013644A1 (fr) * 2016-07-12 2018-01-18 3R International Co., Ltd. Système de support de vie extracorporel

Also Published As

Publication number Publication date
TR202021534A1 (tr) 2022-07-21

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