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WO2016118114A1 - Poumon artificiel intracorporel - Google Patents

Poumon artificiel intracorporel Download PDF

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Publication number
WO2016118114A1
WO2016118114A1 PCT/US2015/012029 US2015012029W WO2016118114A1 WO 2016118114 A1 WO2016118114 A1 WO 2016118114A1 US 2015012029 W US2015012029 W US 2015012029W WO 2016118114 A1 WO2016118114 A1 WO 2016118114A1
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WO
WIPO (PCT)
Prior art keywords
blood
oxygen
chamber
working chamber
pulmonary
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/US2015/012029
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English (en)
Inventor
Michael MIRZOYAN
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Individual
Original Assignee
Individual
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Filing date
Publication date
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Priority to PCT/US2015/012029 priority Critical patent/WO2016118114A1/fr
Publication of WO2016118114A1 publication Critical patent/WO2016118114A1/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
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/32—Oxygenators without 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/32—Oxygenators without membranes
    • A61M1/322—Antifoam; Defoaming
    • A61M1/325—Surfactant coating; Improving wettability
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/04—General characteristics of the apparatus implanted

Definitions

  • the present invention relates to medical devices. More specifically, the invention is an artificial lung device that is safe, effective, and amenable within a patient's vascular structure.
  • the lung is the most important organ in the respiratory system. In the lung, venous blood is relieved of carbon dioxide and then oxygenated by air drawn through the trachea and bronchi into the alveoli.
  • air travels from the mouth and nasal passage to the pharynx and the trachea.
  • Two main bronchi one on each side, extend from the trachea.
  • the main bronchi divide into smaller bronchi, one for each of the five lobes. These further divide into a greater number of smaller bronchioles.
  • each lobe there are about 50 to 80 terminal bronchioles in each lobe. Each of these divides into two respiratory bronchioles, which in turn divide to form 2 to 11 alveolar ducts.
  • the alveolar sacs and alveoli arise from these ducts.
  • the spaces between the alveolar sacs and alveoli are called atria.
  • Lung disease remains one of the major healthcare problems in the United States today.
  • Two significant contributors to lung diseases are interstitial lung disease (ILD) and chronic obstructive pulmonary disease (COPD).
  • ILD interstitial lung disease
  • COPD chronic obstructive pulmonary disease
  • Interstitial Lung Disease is a broad term applied to disorders of both known and unknown etiology characterized by fibrosis and inflammation.
  • ILD Interstitial Lung Disease
  • Examples of known etiologies for ILD include occupational exposures (silicosis, asbestosis, berylliosis, coal miner's pneumoconiosis and hard metal pneumoconiosis), infectious exposures (fungal disease and post- viral syndromes), systemic rheumatoid disorders (rheumatoid arthritis, systemic lupus erythematosis, Sjogren's syndrome, systemic sclerosis, dermatomyositis/ polymyositis, mixed connective tissue disease and ankylosing spondilytis) and other miscellaneous causes (drug- induced pneumonitis, oxygen toxicity, radiation exposure, hypersensitivity pneumonitis and ARDS sequelae). Fibrotic/ inflammatory interstitial lung disease of unknown et
  • COPD chronic obstructive pulmonary disease
  • ILD ILD
  • chronic obstructive pulmonary disease is a persistent, irreversible condition that s l o w l y progresses over time.
  • COPD refers to the existence or coexistence of chronic bronchitis and emphysema and is characterized by obstructed airways, enlarged air spaces, destruction of lung parenchyma, occlusion of small airways, and reduced lung elasticity.
  • patients with advanced stages of COPD are required to expend 10 to 20 times more effort to facilitate breathing.
  • Drug therapies to improve the patient's ailing condition are the least invasive and most readily deployed treatments of lung failure.
  • Mechanical ventilation is the most common therapy and serves to maintain respiratory function by rhythmically inducing a controlled flow of air into the lungs.
  • normal breathing consists of contracting the diaphragm to distend the lungs and create negative pressure between the atmosphere and the lungs, therefore forcing fresh air into the lungs.
  • the diaphragm relaxes, compressing the lungs and forcing expiratory air into the external environment.
  • Mechanical ventilation creates this effect but in an opposing manner; fresh air is driven into the lungs by positive pressure and expiratory air is pumped out of the lungs by negative pressure.
  • VI LI ventilator-induced lung injury
  • the third clinical therapy that is often administered utilizes a membrane oxygenator and an accompanying flow circuit.
  • the treatment is denoted as extracorporeal membrane life support (ECLS), often times referred to as extracorporeal membrane oxygenation (ECMO).
  • ECLS extracorporeal membrane life support
  • ECMO extracorporeal membrane oxygenation
  • ECLS is employed under circumstances of severe, reversible respiratory failure, or to patients responding adversely to all advanced modes of mechanical ventilation. Operation of the circuit relies on a pump to draw blood from the vena cava, transport it through the membrane oxygenator, and return the blood either to the right atrium (venovenous bypass) or aorta (venoarterial bypass). Patients still receive mechanical ventilation while on ECLS; however, settings are reduced to minimize VILI as a result of the exchange of blood gases in the oxygenator. With less work required from the lungs, ECLS permits physiological complications to abate. The therapy can be applied for weeks barring complications.
  • ECLS circuit In addition to this, the ECLS circuit must also be constantly monitored for mechanical failures such as tubing degradation, oxygenator or pump failure, and presence of gaseous emboli or clot formation. Other noted complications include sepsis and renal failure. Finally, ECLS requires a multidisciplinary team to provide care. Overall cost of the procedure, including compensation for medical personnel, as well as restriction to major medical centers are further limitations to providing this therapy. The high overall cost of the procedure coupled with the fact that only major medical centers are outfitted to properly perform it hinder the widespread use of this therapy.
  • intravascular respiratory support devices to facilitate carbon dioxide removal from the circulation provides an advantage over sole mechanical ventilation strategies.
  • intravascular respiratory therapy allows ventilation at lower tidal volumes and pressures and thereby eliminates the deleterious effects that often develop with mechanical ventilation. Decreasing the intensity of the mechanical ventilation has been shown to improve mortality rates.
  • the lung tissue affected by disease experiences a lower workload since the device itself is performing partial respiratory function. The reduced workload allows the injured tissue to rest and may improve tissue recovery.
  • this invention is a vastly improved version.
  • the general purpose of the present invention is to provide a new and improved intra- corporeal gas exchange device without the disadvantages discussed above.
  • the invention provides an artificial lung device, including an inner sphere where pulmonary blood and oxygen mix.
  • This inner sphere has about 200 to 400ml internal capacity.
  • a vertical mesh chamber septum extends from the bottom of the working chamber and divides the inner sphere into two chambers of equal volume: a blood chamber and an oxygen chamber.
  • the system also includes a pulmonary blood tube, which is situated in the lower 1/3 of the inner chamber.
  • the pulmonary blood tube is internally separated by an impermeable septum.
  • the system also includes an oxygen tube situated in the lower 1/3 of the working chamber, across the pulmonary blood tube. The end of the oxygen tube is not porous, which prevents oxygen bubbles from crossing the vertical septum and entering the blood chamber.
  • the system also includes a one-way valve, which open towards the oxygen chamber.
  • the system also includes an oval shaped fenestrated external cover outside of the working chamber to protect the inner sphere from external compression by organs such as the diaphragm and mediastinum.
  • the external cover is fenestrated by numerous larger holes, e.g. 4 -5 mm ID, which will allow the gas or occasional blood spills from the working chamber, to escape into the chest.
  • the system also includes a horizontal septum fenestrated by 4-5 mm (ID) holes. This septum is situated in the upper 1/3 of the working chamber and at the upper end of the vertical inter chamber septum.
  • ID 4-5 mm
  • the system also includes a one-way valve with external diameter of 2 to 5 cm, situated around the oxygen hose at the entrance/exit of the oxygen hose to/from the chest. This one-way valve opens toward the outside of the chest.
  • the system also includes two symmetrically situated hermetic bearings, each located around the blood and oxygen tubes exactly across from each other, incorporated in the wall of the working chamber.
  • the devices of this invention are safe in operation, effective, clinically acceptable, and amenable to easy insertion.
  • the increased gas exchange efficiency (both C02 removal and 02 exchange) of the devices and systems of the present invention allow the devices and systems to be fabricated with relatively small outer diameters.
  • the devices of the present invention are primarily made of plastic and several light metal parts which are designed for placement in the right and/or left hemi-thorax, i.e. right and/or left chest.
  • FIG.l illustrates embodiment of an artificial lung device of the present invention.
  • FIG. 2 illustrates a vertical cross-section of a inter chamber septum.
  • FIG. 3 illustrates a vertical cross-section of a pulmonary blood tube A and an oxygen tube B.
  • the device shown in Fig.l illustrates embodiment of an artificial lung device of the present invention. It describes a working chamber (inner sphere) 1 with 8-9 cm internal diameter and up to 400 ml, is the place where the pulmonary blood and oxygen mix. A 3 ⁇ 4th of the working chamber (up to the horizontal septum 2) is prefilled with sterile crystalloid solution (e.g. normal saline) prior to employment of the device.
  • sterile crystalloid solution e.g. normal saline
  • FIG. 2 provides a vertical inter chamber septum 3, about 0.5 to 1cm thick, that separates the blood chamber 4 from the oxygen chamber 5 and extends from the bottom of the working chamber to 3 ⁇ 4 of the height of the working chamber.
  • the vertical inter chamber septum is fenestrated by l mm internal diameter (ID) channels 6, coursing at a 45 degree angle to the vertical axis of the septum, with the higher points of the channels open to the oxygen chamber 5 and the lower points of the channels open to the blood chamber 4.
  • ID internal diameter
  • FIG.l and 3A Another embodiment of the present device Fig.l and 3A provides a pulmonary blood tube 7 which is situated in the lower 1/3 of the working chamber with an internal diameter of 1.5 cm. It is to be noted that the minimal diameter necessary to assure that the pulmonary arterial portion of the pulmonary blood tube has a sufficient diameter for the pulmonary arterial pressure must not exceed 15mm Hg during systole.
  • the pulmonary blood tube is separated internally by an impermeable septum 8 into two halves.
  • the upper half of the tube is the pulmonary arterial portion 9, which carries deoxygenated blood from the right ventricle of the heart into the blood chamber 4.
  • the lower half is the pulmonary venous portion 10 that carries the oxygenated pulmonary venous blood from the blood chamber toward the left atrium of the heart.
  • the proximal and distal points of the arterial and venous portions of the pulmonary blood tube contain one way valves 11 and 12 in their respective one-way directions.
  • the septum inside the pulmonary blood tube is incomplete, i.e. it ends with a gap 13 at the end of the septum and the diameter of this gap must be close to the diameter of the arterial portion of the tube.
  • the communication provided by this gap at the end of the septum in the pulmonary blood tube may elicit a desirable venturi effect during systole, when pulmonary arterial blood is rushed through this gap inside the pulmonaryvenous portion, pulling oxygenated blood from the working chamber around the pulmonary blood tube via pores.
  • oxygenated blood will return to the heart via pores in the venous portion of the pulmonary blood tube 10 , facilitated by the gravity effect of the blood weight above the pulmonary blood tube in conjunction with constant movement of the blood within the working chamber 1 produced by continuous oxygen flow in the neighboring oxygen chamber 5.
  • the entire perimeter of the pulmonary blood tube inside the working chamber (including arterial and venous portions, as well as the end of the tube) has 2 mm ID pores 23.
  • the pulmonary blood tube exits the working chamber, and after passing the external cover 14, transitions into 2 synthetic vascular grafts (Not shown): the upper vascular graft is attached to the native pulmonary artery, and the lower graft is to the native pulmonary veins.
  • FIG.3 B Another embodiment of the present device Fig.3 B provides an Oxygen (02) tube 15 which is from 0.5 to 1.5 cm (ID) situated in the lower 1/3 of the working chamber, across from the pulmonary blood tube.
  • the oxygen tube is fenestrated with numerous 2 mm (ID) pores 16.
  • ID 2 mm
  • the end 17 of the oxygen tube must not contain pores, since that surface points toward the vertical inter chamber septum.
  • the absence of pores at the end of the oxygen tube serves as an additional safety feature to prevent oxygen bubbles from bombarding the vertical septum and entering the blood chamber.
  • the oxygen tube transitions into a synthetic non compressible hose which leaves the chest and connected to the oxygen source.
  • a high efficiency particulate filter HEPA should be employed before oxygen from the oxygen source enters the oxygen hose. Continuous flow of oxygen at 4-6 L/min should suffice to provide optimal gas exchange with respect to oxygenation and ventilation of the pulmonary arterial blood entering the working chamber.
  • a weight 19 in order to prevent the working chamber full of blood to turn upside down.
  • the goal of this design is to make the lower half wall of the working chamber heavier than the upper half, which could also be achieved by making the lower half of the working chamber of metal and the upper half of plastic.
  • this weight allows the working chamber to gravitate around its horizontal axis formed by blood and oxygen tubes, and keeping the working chamber in the gravity dependent patient's position at upright, semi-upright, supine, prone and upside down .
  • Another embodiment of the present invention is provides a horizontal 1-2 mm septum 2 fenestrated by 4-5 mm holes.
  • This septum is situated in the upper 1/3 of the working chamber 1 above the upper end of the vertical inter chamber septum 3.
  • the horizontal septum will restrain blood movement inside the working chamber when the recipient of the device is in motion, and may play a role in a mechanical defoaming of the blood when the foamed blood goes up inside the oxygen chamber 5.
  • the device comprises two one-way valves 20 situated in the roof of the working chamber to vent the gas (C02 and 02) outside of the working chamber.
  • hermetic bearings 21 and 22 there are two symmetrically situated hermetic bearings 21 and 22, each of which is located around the blood 7 and oxygen 15 tubes exactly across each other.
  • Each of these bearings is incorporated into the wall of the working chamber.
  • These bearings form a horizontal axis around the blood and oxygen tubes.
  • the blood and oxygen tubes run inside the bearings, and are sealed and fixed statically (hermetically) with inner portion of bearings. Because the working chamber has a heavier lower half, gravitational rotational movement will occur around the blood and oxygen tubes.This will keep the device in a gravity dependent position constantly.
  • an oval shaped fenestrated external cover 14 outside of the working chamber e.g. 16 cm/height x 16cm/breadth x 13cm/length or 14cm x 14cm x 11cm, it depends on the diameter of the working chamber, e.g. 9 vs 8 cm etc., in order to allow the working chamber to make a 360 degrees unrestricted move inside the external cover).
  • the function of the external cover is to protect the working chamber from external compression/impingement by intra thoracic organs such as the diaphragm and mediastinum.
  • the gap between the external cover and the working chamber varies from 0.5 to 2 cm in their closest proximity to each other.
  • the external cover is fenestrated by numerous larger holes 24, e.g.4- 5 mm ID, which allow gas (C02 and 02) or occasional spills of blood from the working chamber to escape into the chest.
  • the oxygen and blood tubes are fixed statically inside the external cover when they pass through it.
  • Another preferred embodiment of said invention includes a rectangular plate fixed on the back of the external cover with 4 to 8 screw points for a screw fixation of the plate to the posterior ribs inside the chest, positioning the working chamber at the level of the heart.
  • the purpose of this plate is to provide the means of attachment of the device inside the chest.
  • a one-way valve with external diameter of 2 to 5 cm is situated around the oxygen hose at the entrance/exit of the oxygen hose to/from the chest. This one-way valve opens toward outside of the chest to release pressure that builds inside of the chest and to prevent ambient air from entering the chest.
  • the present device is coated with anti-adhesive film/surface like Teflon to prevent blood from fibrin/thrombosis formation within the device.
  • anti-adhesive film/surface like Teflon to prevent blood from fibrin/thrombosis formation within the device.
  • patients must be placed on a long-term anticoagulation regimen after receiving this device.
  • thrombolytic agent such as Alteplase through a special port on the oxygen hose outside of the chest to prevent formation or degrade already formed fibrin/blood clots inside the working chamber.
  • the device disclosed in the aforementioned disclosure could be made of plastic or light metal which does not restrict or limit the scope of invention, which allows the person skilled in the art in any future modification of related art.
  • the present invention will preferably be used inside of the body.
  • the device is designed for placement in the right and/or left hemi-thorax, i.e. right and/or left chest.
  • This device or its modifications could also be used as an artificial lung intra- corporeally, i.e. inside the human body or extra-corporeally, i.e. outside the human body.
  • the aforementioned dimensions are merely examples and could be customized to suit a patient's need should the device be required depending on the size of a chest cavity if the device to be employed inside the body.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Emergency Medicine (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (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)

Abstract

La présente invention concerne un nouveau poumon artificiel inséré à l'intérieur du thorax humain. Les principes régissant la fonctionnalité de ce dispositif sont la rotation dépendant de la gravité et la séparation de l'oxygène du système circulatoire par gravité, différents diamètres de pores sur le tube d'oxygène avec des canaux inclinés dans le septum maillé vertical et l'incorporation de clapets anti-retour. D'autres avantages de la conception : elle ne contient pas de fibre poreuse et sa souplesse et sa capacité inhérentes peuvent jouer un rôle décisif dans la prise en charge à long terme de patients atteints d'une insuffisance respiratoire et remplacer le besoin de greffes du poumon. De plus, la conception présente un volume sanguin primaire relativement petit et prend en considération la prévention de la déformation du ventricule droit en maintenant la pression artérielle pulmonaire à l'intérieur de la plage physiologique. Sa position dans la circulation pulmonaire en anastomose parallèle est considérée moins stressante pour le cœur. La relative simplicité du dispositif relativement à l'état de la technique est un autre avantage remarquable.
PCT/US2015/012029 2015-01-20 2015-01-20 Poumon artificiel intracorporel Ceased WO2016118114A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2015/012029 WO2016118114A1 (fr) 2015-01-20 2015-01-20 Poumon artificiel intracorporel

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2015/012029 WO2016118114A1 (fr) 2015-01-20 2015-01-20 Poumon artificiel intracorporel

Publications (1)

Publication Number Publication Date
WO2016118114A1 true WO2016118114A1 (fr) 2016-07-28

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3927981A (en) * 1972-08-30 1975-12-23 Rhone Poulenc Sa Membrane-type blood oxygenator with recycle of oxygen-containing gas
US4205042A (en) * 1978-06-23 1980-05-27 Cobe Laboratories, Inc. Blood oxygenator with a gas filter
US4231988A (en) * 1978-06-13 1980-11-04 Japan Medical Supply Co., Ltd. Artificial lung
US4765959A (en) * 1981-11-13 1988-08-23 Terumo Kabushiki Kaisha Blood circulating circuit for membrane-type artificial lung, and reservoir for use in blood circulating circuit
JPH11146915A (ja) * 1997-11-18 1999-06-02 Hideto Kaneyasu 人工呼吸器を血液ポンプの駆動源と同時に酸素加混合ガス供給源に用いた呼吸循環補助装置
US20020143397A1 (en) * 2001-04-02 2002-10-03 Von Segesser Ludwig K. Compliant artificial lung for extrapulmonary gas transfer
US20080295828A1 (en) * 2007-06-02 2008-12-04 Lande Arnold J Artificial gills for deep diving without incurring the bends and for scavenging O2 from and dispelling CO2 into water or thin air
US20110040241A1 (en) * 2009-08-11 2011-02-17 Dongfang Wang Blood access assembly for artificial lung and right ventricular assist device
US8142546B2 (en) * 2004-07-23 2012-03-27 Terumo Kabushiki Kaisha Artificial lung

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3927981A (en) * 1972-08-30 1975-12-23 Rhone Poulenc Sa Membrane-type blood oxygenator with recycle of oxygen-containing gas
US4231988A (en) * 1978-06-13 1980-11-04 Japan Medical Supply Co., Ltd. Artificial lung
US4205042A (en) * 1978-06-23 1980-05-27 Cobe Laboratories, Inc. Blood oxygenator with a gas filter
US4765959A (en) * 1981-11-13 1988-08-23 Terumo Kabushiki Kaisha Blood circulating circuit for membrane-type artificial lung, and reservoir for use in blood circulating circuit
JPH11146915A (ja) * 1997-11-18 1999-06-02 Hideto Kaneyasu 人工呼吸器を血液ポンプの駆動源と同時に酸素加混合ガス供給源に用いた呼吸循環補助装置
US20020143397A1 (en) * 2001-04-02 2002-10-03 Von Segesser Ludwig K. Compliant artificial lung for extrapulmonary gas transfer
US8142546B2 (en) * 2004-07-23 2012-03-27 Terumo Kabushiki Kaisha Artificial lung
US20080295828A1 (en) * 2007-06-02 2008-12-04 Lande Arnold J Artificial gills for deep diving without incurring the bends and for scavenging O2 from and dispelling CO2 into water or thin air
US20110040241A1 (en) * 2009-08-11 2011-02-17 Dongfang Wang Blood access assembly for artificial lung and right ventricular assist device

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