WO2021162564A1 - Dispositif d'assistance ventriculaire gauche implantable et système d'assistance ventriculaire à utiliser chez des patients présentant une insuffisance cardiaque terminale - Google Patents

Dispositif d'assistance ventriculaire gauche implantable et système d'assistance ventriculaire à utiliser chez des patients présentant une insuffisance cardiaque terminale Download PDF

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Publication number
WO2021162564A1
WO2021162564A1 PCT/PL2021/050004 PL2021050004W WO2021162564A1 WO 2021162564 A1 WO2021162564 A1 WO 2021162564A1 PL 2021050004 W PL2021050004 W PL 2021050004W WO 2021162564 A1 WO2021162564 A1 WO 2021162564A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
ventricular
valve
supply pipe
balloons
Prior art date
Application number
PCT/PL2021/050004
Other languages
English (en)
Inventor
Leszek Dabrowski
Ryszard JASINSKI
Krzysztof TESCH
Justyna Kucinska-Lipka
Maciej Sienkiewicz
Jan ROGOWSKI
Dariusz JAGIELAK
Maciej KEMPA
Radoslaw Nowak
Original Assignee
Medarch Sp. Z O.O.
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 Medarch Sp. Z O.O. filed Critical Medarch Sp. Z O.O.
Priority to PL442142A priority Critical patent/PL442142A1/pl
Publication of WO2021162564A1 publication Critical patent/WO2021162564A1/fr

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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
    • 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
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • 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
    • A61M60/20—Type thereof
    • A61M60/295—Balloon pumps for circulatory assistance
    • 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
    • A61M60/40—Details relating to driving
    • A61M60/497—Details relating to driving for balloon pumps for circulatory assistance
    • 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
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
    • 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
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/562—Electronic control means, e.g. for feedback regulation for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
    • A61M60/569—Electronic control means, e.g. for feedback regulation for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow synchronous with the native heart beat
    • 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
    • A61M60/841—Constructional details other than related to driving of balloon pumps for circulatory assistance
    • A61M60/843—Balloon aspects, e.g. shapes or materials
    • 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
    • A61M60/89—Valves
    • A61M60/892—Active valves, i.e. actuated by an external force

Definitions

  • the field of the invention is a device for supporting the work of the left ven tricle in the form of a flexible balloon.
  • the present invention refers to an implantable device for supporting/assisting the heart in patients, known also as implantable left ventricular assist device, with end-stage heart failure associated with mitral valve insufficiency and pulmonary hypertension.
  • the invention also relates to a sys tem/unit for ventricular assist with said left ventricular support/assist device.
  • the invention is used in particular when patients are resistant to pharmacological treat ment and due to their health condition or for some other reason when extensive car diac surgery cannot be performed.
  • Ventricular assist devices take over the full function of pumping one or both sides of the failing heart, discharging the supported ventricle.
  • Left ventricular assist devices have been approved by the FDA as a bridge to a sternum transplant to keep patients alive while waiting for a donor heart. Such devices have also been approved for use by patients with heart failure, however, in cases where a temporary reduction in the load on the heart muscle (discharge) allows the heart muscle to recover more quickly in patients at risk of postoperative heart failure in particular.
  • EP1129736 discloses a method and a ventricular assist device that may be used in the treatment of heart failure and at the same time delay the devel opment of end-stage heart failure or provide a temporary solution while the patient is waiting for a transplant.
  • the solution supports the heart (left or right ventricle) with all healthy valves.
  • an intraventricular device with a volume limited to 30 ml is used, in which the balloon filled with liquid changes volume, supporting the heart function without inducing stretching of the ventricular wall.
  • the balloon consists of two volumes: intraventricular and extraventricular.
  • the balloon inflation control consists in moni toring the wall.
  • a cardiac assist de vice which consists of at least two electromagnetic plates consist of an inner surface and being electrically coupled to at least one of the heart processor plates and a bal loon having an inner chamber, a balloon attached to the inner surface of at least one of the two electromagnetic plates, a gas source in communication with the inner chamber of the balloon and a catheter having a proximal and distal tip.
  • the proximal end of the catheter is connected to the inner chamber of the balloon and the distal end is locates in the pericardial space and is used to inject or remove gas from the peri cardial space.
  • the purpose of the present invention is to provide an implantable left ventric ular assist/support device that meets the expected functionality and overcomes the problems of known solutions.
  • the device has been provided in order to assist - in other meaning support - the work of the left ventricle in the form of a balloon forming an intra-cardiac inert gas-filled working chamber, divided by narrowing, known also as narrowed space/area, formed within the working chamber, into two spaces known as areas - inflated with gas during use.
  • the two spaces connected by a narrowing comprises a smaller and larger chamber which are inflated and deflated with gas during use by means of a suction and discharge device/unit, forming a valve balloon and a ventricular balloon, respectively.
  • the balloon unit which is named as said chambers, is inflated and deflated during use with an inert gas, e.g. helium.
  • an inert gas e.g. helium.
  • the invention also relates to the left ven tricular support system known also as unit which comprises said device - the balloon unit and the system enabling and controlling the work of the balloon unit in the heart - i.e. the inflation and deflation of the chambers according to the heart rate and creat ing balloons - the chambers - with variable ventricular volumes, including e.g. suc tion/discharge device.
  • the balloon unit is an intra-cardiac, expandable and contractible working chamber divided into a smaller chamber filled with gas - a balloon being finally im planted/inserted into a valve, named therefore as the valve balloon; and a larger chamber being finally implanted into the left ventricle named therefore as a ventricu lar balloon.
  • the working chamber is thus divided by narrowed area within the work ing chamber, into two sub-chambers, created in the patient's heart by expanding the chamber space by gas and then contracting it.
  • the working chamber is divided by a narrowing formed in the working chamber - narrowed area made between the transi tion of one balloon to the other - in the lower part, at the end of the valve balloon.
  • the pneumatic gas supply line/pipe is divided into a valve supply line while outlet of the line - opening is located inside the valve balloon and allows gas to flow into or out of the valve balloon and a ventricular gas supply line while outlet of the line - exit is located inside the ventricular balloon.
  • one pneumatic gas line supplying both balloons is made.
  • the one gas line has at least two outlets, i.e. inside the valve balloon and fur thermore has an additional outlet (or opening in the line) inside the ventricular bal loon allowing inflation and deflation of the ventricular balloon - expansion and con traction of chamber spaces.
  • An additional outlet or outlets of pneumatic supply line- openings may be located above and/or below the narrowing located at the bottom of the valve balloon.
  • the working chamber i.e. a balloon unit
  • the working chamber is filled with helium, which in the event of a possible unsealing of the balloon will not have negative ef fects on the patient to whom the device has been implanted.
  • helium a gas which in the event of a possible unsealing of the balloon will not have negative ef fects on the patient to whom the device has been implanted.
  • the narrowing between the valve balloon and the ventricular balloon adheres over the entire cross section of the narrowing to the outer wall of the pneumatic sup ply line.
  • the pneumatic supply line is located/runs through the entire cross-section of the narrowing, i.e. the narrowing in the cross-section is adjust ed to the size (diameter) of the pneumatic supply line.
  • the pneumatic supply line between the valve balloon and the ventricular balloon partially adheres the outer wall of the pneumatic supply line.
  • the supply line runs, known also as is located, through a part of the narrowing cross-section, i.e. the cross-sectional narrow ing is greater than the size of the pneumatic supply line.
  • sequential inflation of balloons is possi ble, first the valve balloon is inflated with gas and then the ventricular balloon is in flated with.
  • the narrowing is made/fixed in sta ble/stationary form, i.e. of a material that does not deform during use/work of the device (gas transfer), so that gas inflation and deflation in the valve and ventricular balloons are carried out independently.
  • the left ventricular support system/unit comprises, in addition to the above-mentioned assist device, the suction/discharge device, known in the state-of-the-art, and most often made in the form of a gas compressor.
  • the support system is connected to the pneumatic supply lines and to the system controlling the mode of supplying working chamber, i.e. inflating the space of the working chamber.
  • the control system and suction/discharge device it is possible to inflate and deflate the working chamber in rhythm with the normal func tioning of the left ventricle, which is controlled by the control system.
  • both balloons inflate with gas - the formation of a valve balloon and a ventric ular balloon, thus increasing the stroke volume of the heart, while in the diastolic phase, the valve and ventricular balloons deflate.
  • the working of the system in the meaning of use the system with the device, is based on the strategy of pulsating flow that is synchronised with the heart cycle which will avoid the limitations of the methods used so far.
  • the pump runs continuously, i.e. delivers a constant pressure.
  • Any suction/discharge device and con- trol systems known in the state-of-the-art can be used in the system according to the invention.
  • the device may be controlled by external devices and not by the system.
  • Fig. 1-4 present the device in various variants of the pneumatic supply line distributing gas to the working chamber.
  • Fig. 1 shows a cross-sectional view of the device and its location in the left ventricle and the action of the device during diastol ic phase when balloons deflate. The gas is first sucked from the valve balloon then from the ventricular balloon.
  • Fig. 2 shows the cross-section of the device in the vari ant with one pneumatic line supplying both balloons, i.e. when the narrowing be tween the valve balloon and the ventricular balloon partially adheres the outer wall of the pneumatic supply line. Additionally, above the narrowing the pneumatic supply line has an additional outlet, i.e.
  • FIG. 3 shows a cross-sectional view of the device with a single pneumatic line supplying both balloons wherein the outlet of the pneumatic line ends in front of the upper wall of the valve balloon. Additional ly, at the height of the upper part of the ventricular balloon, just before the narrow ing, the pneumatic supply pipe has an additional opening.
  • Fig. 4 shows a cross- section of the device in a variant with two pneumatic supply lines wherein the outlet of the internal valve supply line ends in front of the upper wall of the valve balloon and further has an additional opening at the level of the lower part of the valve bal loon.
  • the external ventricular line supplying the ventricular balloon, is positioned in the upper part of the ventricular balloon so that the outlet of the external supply line is halfway up the valve supply line and at the level of the mitral valve exit there is an inlet of the supply line. This means that the gas passes through the internal supply line upwards and the external supply line downwards.
  • Valve balloon 1 and ventricular balloon 2 as a balloon unit as a balloon unit.
  • both supply lines (valve line 5 and ventricular line 6) are matched such that the outer diameter of the line 5 is small er than the inner diameter of the line 6 and that line 5 is located inside line 6. It is possible to adjust differences between the diameters of lines 5 and 6 to ensure opti mum gas flow rate during balloon inflation and deflation.
  • FIG. 2 Another embodiment of the pneumatic supply line is shown in Fig. 2.
  • One pneumatic supply line for both balloons is made (line 5) wherein the outlet end of this supply line terminates in front of the upper wall of the valve balloon 1. Additionally, above the narrowing the supply line 5 has an additional opening that allows an increased gas inflation and deflation into the valve balloon 1.
  • Fig. 3 one pneumatic supply line 5 for supplying both balloons is made. The outlet of the supply line 5 terminates in front of the upper wall of the valve balloon 1. Additionally, at the height of the upper part of the ventricular balloon 2, just before the narrowing P, the supply line 5 has an additional opening that allows the gas to inflate and deflate into the ventricular balloon 2.
  • two pneumatic supply lines are provided.
  • the internal supply line 5 of the valve bal loon 1 the outlet of which terminates in front of the upper wall of the valve balloon 1 and which has an additional opening at the level of the lower part of the valve bal loon 1 that allows the gas to inflate and deflate into the valve balloon 1.
  • the external supply line 6, supplying the ventricular balloon 2 is located in the upper part of the ventricular balloon 2 so that the outlet of the supply line 6 is halfway up the internal supply line 5 and at the level of the mitral valve exit there is an inlet of the supply line 6.
  • both supply lines 5 and 6 are matched in such a way that the outer diameter of the line 5 is smaller than the inner diameter of the line 6 and that line 5 is located inside line 6. It is possible to adjust differences between the diame ters of lines 5 and 6 to ensure optimum gas flow rate during balloon inflation and deflation.
  • the balloons and the narrowing as a whole are made of thermoplastic elastomer by vacuum thermoforming, e.g. the balloons are made of thermoplastic elastomer by vacuum thermoforming in a subsequent step thermoformed.
  • thermoplastic elastomer with different hardness in the range of 30 Sh A to 95 Sh D while the thermoplastic elastomer may be stiffened locally by incorporating a metal mesh or synthetic fibre mesh, in the area from which the base wall of the balloon assembly will be formed during the thermoforming stage.
  • the balloon unit and the narrowing are made of one or at least two thermoplastic elastomer sheets of different thickness wherein the combined thickness of the sheets is at most 5 mm and in this case 5 mm.
  • SIL PROMESH - polyeth ylene/silicone, Optomesh Ultralight L-Pore-polypropylene, PROMESH® SOFT EVOLUTION-polyester Stiffening in the form of a metal mesh or a mesh made of synthetic fibres is introduced into the structure of a balloon unit, i.e. the wall of the base of the working area at the thermoforming stage (by placing them on the form and pressing a plasticised sheet of thermoplastic elastomer with the consistency of a plastic mass) thus stiffening is permanently integrated into the wall of the balloon base.
  • Receipt - example A Receipt - example A.
  • 19 ml of hexane and 3 ml of acetone are placed in the flasks, 0.2052 g of the anticoagulant compound and sheets are measured.
  • the contents are stirred for lh at 50°C. After this time, the sheets are pulled out of the flask and are washed with hexane.
  • the solution according to the invention allows to increase the ejection volume of blood, also to reduce the wedge pressure, to reduce the pressure in the pulmonary trunk, to reduce the systolic pressure in the right ventricle and to reduce the triple feedback wave which leads to an improvement in the haemodynamic conditions of the heart and its efficiency. Additionally, the solution according to the invention is used to sustainably support the circulation of the left ventricle. This allows for mini mally invasive implantation through the aorta and removal when the function of the left ventricle improves without the need for extensive cardiac surgery which is asso ciated with the use of extracorporeal circulation, general anesthesia and endotracheal intubation and therefore with an increased risk of complications.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Geometry (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif d'assistance ventriculaire gauche implantable destiné à assister le ventricule gauche. Le dispositif est caractérisé en ce qu'une chambre de travail est divisée par un espace rétréci (P) formé à l'intérieur de la chambre en deux espaces reliés se présentant sous la forme d'une petite chambre et d'une grande chambre, qui sont gonflées et dégonflées à l'aide d'un gaz formant un ballonnet valvulaire (1) et un ballonnet ventriculaire (2). Le volume variable du ballonnet valvulaire (1) est adapté à l'anatomie de l'anneau mitral, et le volume variable du ballonnet ventriculaire (2) est adapté à l'anatomie du ventricule gauche. A l'intérieur de la chambre de travail se trouve un conduit d'alimentation pneumatique à travers lequel du gaz est introduit dans l'espace des chambres ou évacué hors de celui-ci. La présente invention concerne le système d'assistance ventriculaire comprenant ledit dispositif d'assistance ventriculaire gauche et un dispositif connu d'aspiration et d'évacuation pour le gonflage et le dégonflage des chambres et un système de commande pour commander le mode d'écoulement du gaz dans la chambre de travail.
PCT/PL2021/050004 2020-02-14 2021-02-12 Dispositif d'assistance ventriculaire gauche implantable et système d'assistance ventriculaire à utiliser chez des patients présentant une insuffisance cardiaque terminale WO2021162564A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PL442142A PL442142A1 (pl) 2020-02-14 2021-02-12 Wszczepialne urządzenie do wspomagania pracy lewej komory serca oraz układ do wspomagania pracy lewej komory serca u pacjentów ze schyłkową niewydolnością serca

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PL432906A PL432906A1 (pl) 2020-02-14 2020-02-14 Wszczepialne urządzenie do wspomagania pracy lewej komory serca
PLP.432906 2020-02-14

Publications (1)

Publication Number Publication Date
WO2021162564A1 true WO2021162564A1 (fr) 2021-08-19

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PCT/PL2021/050004 WO2021162564A1 (fr) 2020-02-14 2021-02-12 Dispositif d'assistance ventriculaire gauche implantable et système d'assistance ventriculaire à utiliser chez des patients présentant une insuffisance cardiaque terminale

Country Status (2)

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PL (2) PL432906A1 (fr)
WO (1) WO2021162564A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1129736A1 (fr) * 2000-03-02 2001-09-05 Levram Medical Devices, Ltd. Méthode et Dispositif d'assistance ventriculaire
CN106419970A (zh) * 2016-08-03 2017-02-22 江苏大学 一种经心尖植入的支撑杆式二尖瓣气囊闭合板阻塞体及植入方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1129736A1 (fr) * 2000-03-02 2001-09-05 Levram Medical Devices, Ltd. Méthode et Dispositif d'assistance ventriculaire
CN106419970A (zh) * 2016-08-03 2017-02-22 江苏大学 一种经心尖植入的支撑杆式二尖瓣气囊闭合板阻塞体及植入方法

Also Published As

Publication number Publication date
PL442142A1 (pl) 2023-01-16
PL432906A1 (pl) 2021-08-16

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