WO2023092200A1 - Dispositif endovasculaire de capture et d'élimination de thrombus - Google Patents

Dispositif endovasculaire de capture et d'élimination de thrombus Download PDF

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Publication number
WO2023092200A1
WO2023092200A1 PCT/BR2021/050573 BR2021050573W WO2023092200A1 WO 2023092200 A1 WO2023092200 A1 WO 2023092200A1 BR 2021050573 W BR2021050573 W BR 2021050573W WO 2023092200 A1 WO2023092200 A1 WO 2023092200A1
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WO
WIPO (PCT)
Prior art keywords
catheter
balloon
ring
bag
thrombi
Prior art date
Application number
PCT/BR2021/050573
Other languages
English (en)
Portuguese (pt)
Inventor
George NEVES DE ALMEIDA
Original Assignee
Neves De Almeida George
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
Priority claimed from BR102021023636-1A external-priority patent/BR102021023636A2/pt
Application filed by Neves De Almeida George filed Critical Neves De Almeida George
Publication of WO2023092200A1 publication Critical patent/WO2023092200A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • A61M25/10—Balloon catheters

Definitions

  • the present invention patent is part of the health area and consists of a device for removing thrombi (blood clots) from within the pulmonary artery of adult humans, consisting of a catheter with three lumens, on which a balloon is mounted semi-compliant ring-shaped balloon, called a ring-balloon, which is expanded from its collapsed form by being inflated with saline solution, injected through two of the catheter lumens, a ring-balloon that has a mouth attached to its outer edge of a conical mesh bag, porous to blood but impermeable to thrombi, composing together with the balloon-ring an object similar to a windsock, whose function is to capture the thrombi, and three threads that keep the balloon-ring attached to the catheter and serve as a means to pull and collect the balloon-ring into a sheath after capturing the thrombi.
  • thrombi blood clots
  • Pulmonary embolism is the obstruction of the pulmonary artery and/or its branches by clots brought by venous blood flow, usually originating in veins of the lower limbs.
  • the trunk of the pulmonary artery is the outflow tract of the right ventricle of the heart and divides into the right and left pulmonary arteries, which go to the respective lungs.
  • Massive and submassive pulmonary embolism is a serious disease, with high morbidity and mortality, characterized by obstruction of the pulmonary arteries and/or their main branches by large masses of thrombi, being one of the main causes of in-hospital death.
  • a device that can quickly and minimally invasively remove most of the thrombi could be very useful for the treatment of massive and submassive pulmonary embolism.
  • thromboembolism of the pulmonary artery can be treated through surgical opening of this artery, or through endovascular percutaneous thrombectomy devices, or through systemic drug thrombolysis.
  • a surgical opening of the thorax is performed, opening the pulmonary artery and extracting the thrombi inside it. This method is not usually used because it is a major surgery, with high patient morbidity and mortality.
  • a catheter is introduced through the femoral vein, through percutaneous puncture and progressed through the vascular system, passing through the right heart chambers, until reaching the pulmonary artery, under real-time visualization in a radioscopy device (hemodynamics). ). Once the catheter reaches the pulmonary artery, a thrombectomy device is taken through the same route to the pulmonary artery and used for fragmentation and/or aspiration of thrombi, such as those described below.
  • the Indigo-Penumbra device is a catheter that aspirates clots inside the vessel through negative pressure, with the aid of a mobile ogive at the end of the catheter, used to fragment the thrombus into smaller pieces. Aspiration time may be limited by the volume of blood removed along with the thrombi. Its angled tip allows for some maneuverability and amplitude, but with a limited range of action within the lumen of a large vessel such as the pulmonary artery.
  • This device obtained good clinical results in the treatment of severe pulmonary thromboembolism, by partially removing the thrombi from the pulmonary artery, with improved lung perfusion and reduced overload on the right heart (Indigo Aspiration System for Treatment of Pulmonary Embolism: Results of the EXTRACT- PE Trial).
  • This device differs from the object of this patent application as it is a thrombus aspiration catheter.
  • the Flowtriever device consists of an aspiration catheter and a metallic mesh. Aspiration is done through suction through a syringe, always bringing some volume of blood with it. The capture of thrombi is done by expanding the metal mesh through the thrombi, which causes shearing of the thrombi and their penetration and apprehension in the metal mesh. The mesh is then collected to inside the catheter, bringing with it the thrombi. Part of the thrombi may remain in the lumen and possibly some fragments may embolize to distal branches of the pulmonary artery, which is undesirable.
  • This device has also achieved good clinical results in the treatment of severe pulmonary thromboembolism (A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study).
  • This device differs from the object of this patent application because it is a system that depends on the shearing and seizure of thrombi by the metal mesh, associated with a thrombus aspiration catheter.
  • the Aspirex device fragments and aspirates thrombi through a catheter that contains a helical system inside, rotating at high speed.
  • the aspiration time is limited by the volume of blood removed together with the thrombi. Its tip is straight, non-steering, which limits its range of action within the lumen of a large vessel such as the pulmonary artery.
  • This device has not been recommended for the treatment of pulmonary thromboembolism by the main scientific publications on the subject. This device differs from the object of this patent application as it is a thrombus aspiration catheter.
  • the Angiojet device is a catheter that uses a jet of saline and the venturi phenomenon to break up and aspirate clots. Its wearing time is limited by device-induced hemolysis. Fragmentation of thrombi possibly causes embolization to distal branches of the pulmonary artery, which is undesirable.
  • the catheter has a straight, non-steerable tip, which limits its range of action within the lumen of a large vessel such as the pulmonary artery.
  • This device has not been recommended for the treatment of pulmonary thromboembolism by the main scientific publications on the subject. This device differs from the object of this patent application as it is a thrombus fragmentation and aspiration system.
  • Thrombectomy device refers to a thrombectomy device, with a stent structure, essentially cylindrical, which has a variety of meshes, as well as two connectors, arranged in different meshes at the end proximal part of the stent structure, presenting a conductive wire, which has a coupler element, to which the connectors are attached, as well as a slit, which extends in a spiral shape on the lateral face of the stent structure, and with a handle tensioner that covers the crack at the proximal end.
  • This device differs from the object of the present patent application because it depends on the shearing and adhesion of the thrombi to the metal mesh for its removal.
  • Thrombectomy device and system for extracting vascular thrombi from a blood vessel comprises a delivery catheter, a dilator catheter and a funnel, which defines a distal end and a proximal end, in which said funnel is positionable in a retracted position and in an extended position, and is characterized in that said funnel also comprises a cover, wherein the diameter of the distal end of the funnel is greater in the extended position than in the retracted position.
  • This device differs from the object of this patent application as it is a thrombus aspiration catheter.
  • clot removal device for removing occlusive clot from a blood vessel refers to device for removing the clot from a body vessel and comprises an expandable structure and an elongated element.
  • the expandable structure has a constrained release configuration, an expanded clot engaging configuration, and an at least partially constrained clot clamping configuration. At least a portion of the expandable structure is configured to engage the clot in the deployed expanded configuration and to arrest the moving clot from the deployed configuration to the clot capture configuration.
  • the expandable structure may comprise a main body portion and a clot clamping structure wherein a diameter of the clot clamping structure is less than a diameter of the main body portion.
  • the clot clamping structure in some cases is substantially tubular and may be spiral in shape. This device differs from the object of the present patent application because it depends on the shearing and adhesion of the thrombi to the metal mesh for its removal.
  • BR 1 12021007203-9 "Device, apparatus for thrombectomy and system for automated maneuvering of the apparatus for thrombectomy” refers to a device, apparatus for thrombectomy and a method for extracting a thrombus from a blood vessel.
  • the device comprises a segment that changes shape from a retracted position, in a compressed state, to an extended and expanded position.
  • the segment is formed by a mesh of at least two sets of intertwined helical filaments running in opposite directions.
  • the mesh comprises two distinct tubular sections.
  • the mesh of the first section has helical filaments having a braiding angle that provides greater radial forces than the forces in the second section, and thus the first section is positioned against the inner wall of the blood vessel.
  • the second section comprises two subsections.
  • the first subsection is conical in shape and comprises a braiding angle that changes at its proximal and distal ends to provide a radial force to maintain the conical shape and to stop proximal blood flow during thrombus removal.
  • This device differs from the object of the present patent application because it depends on the shearing and adhesion of the thrombi to the metal mesh for its removal.
  • a medication that has the property of dissolving thrombi commonly Alteplase, is administered in high doses into the bloodstream, through a peripheral vein, so that it exerts its action when passing thrombi in the pulmonary artery.
  • thrombolytics act indistinctly on large and small thrombi, located anywhere in the body and, therefore, pose a risk of serious or fatal bleeding complications to patients who have recently undergone surgical interventions, with recent bleeding, victims of major trauma or accidents. recent stroke. About 30% to 40% of patients with severe pulmonary thromboembolism have some contraindication for the use of thrombolytics and, therefore, are candidates for treatment with an endovascular thrombectomy device.
  • Figure 1 illustrates a perspective view of the catheter, the inflated balloon-ring, the open bag, the three extended wires and free ends of the injection lumens;
  • the object of this patent application is composed of a catheter (1), a balloon-ring (2), a bag (3) and three wires (4) and ends of injection lumens (5), described below follow.
  • the catheter (1) is made of plastic material, such as nylon, polyethylene or polyurethane, with one end called the tip of the catheter and the other end called the bottom of the catheter, the bottom being that end that remains outside the patient's body, under control of the physician operating the device.
  • the catheter (1) contains three distinct lumens (5), parallel to each other, one of them, called the main lumen (5), arranged longitudinally along the entire length of approximately 100 cm of the catheter (1), whose purpose is to allow passage to a guide wire with a thickness of 0.035 inches, and the other two lumens, called injection lumens, with an approximate extension of 80 cm from the bottom of the catheter (1 ), and, at the end of this extension, each of the injection lumens it ends at an end detached from the main body of the catheter (1), free and flexible, approximately 8 mm long, through which the saline solution leaves the injection lumen to fill the balloon (2), described below.
  • the main lumen (5) three distinct lumens (5), parallel to each other, one of them, called the main lumen (5), arranged longitudinally along the entire length of approximately 100 cm of the catheter (1), whose purpose is to allow passage to a guide wire with a thickness of 0.035 inches, and the other two lumens, called injection lumens, with an approximate extension of 80 cm
  • the bottom of the catheter (1 ) continues with a tube made of rigid plastic material, with a Y division, in one of which the main lumen of the catheter opens (1 ) and in the other the injection lumens open together, and the Y division through which the guide wire passes has a straight position in relation to the catheter body (1 ).
  • the balloon-ring (2) is made of plastic material, such as nylon, polyethylene or polyurethane, semi-compliant, with a cylindrical body of approximately 3 mm in diameter.
  • This cylinder is shaped like an arc of a circle, with a diameter of approx. of 40 mm and approximate extension of 358 s of the circumference, and the plastic tissue of each of the ends of the arch ends overlapping each of the free ends of the catheter injection lumens (1) described above, through which the balloon (2) it can be inflated with saline solution, which promotes its expansion into a ring shape, which is why it is called a ring balloon (2).
  • the device also has a bag (3) with an approximately conical shape, composed of a malleable fabric mesh, highly porous to blood and impermeable to clots, with a length of approximately 80 mm, whose bottom is closed and fixed near the tip of the catheter (1) and whose mouth is fixed along the most external edge of the balloon-ring (2), so that the expansion of the balloon-ring (2) causes the opening of the mouth of the bag (3), together composing a structure similar to a windsock and so that any content that passes through the inner circle delimited by the balloon-ring (2) enters the bag (3).
  • This set of six parts of the device has an active position of use when the balloon-ring is expanded by the injection of saline solution, using a syringe attached to the bottom of the catheter .
  • the expansion of the balloon-ring causes the mouth of the bag to open and the threads to stretch.
  • the balloon-ring, the bag and the three wires are completely collapsed, folded and juxtaposed to the catheter, so that the The set maintains an approximately cylindrical shape around the catheter and occupies minimal space, and can be easily advanced inside a sheath with an approximate caliber of 9F.
  • a 0.035-inch guidewire and a long sheath are positioned inside the pulmonary artery.
  • the device is then advanced within the sheath, and its tip is positioned within one of the branches of the pulmonary artery, beyond the site obstructed by thrombi.
  • the ring balloon is partially inflated under low pressure and the catheter is slowly pulled back, which should bring thrombi from the arterial branch into the main pulmonary artery.
  • the physician inflates the balloon-ring until its complete expansion, which should promote contact between the outer circumference of the balloon-ring and the inner circumference of the pulmonary artery, and , then, slowly pulls the catheter, causing the balloon-ring to be dragged along the obstructed pulmonary artery, which should force all the contents of the artery (blood and thrombi) to pass through the central circle delimited by the balloon-ring towards the bag, thus promoting the capture of thrombi inside the bag, contributing to this the flow of blood pumped by the right ventricle, pushing the contents of the vessel towards the bag.
  • the entire set can be removed from the pulmonary artery, which should promote clinical improvement for the patient.
  • the thrombi trapped in the bag can then be brought up to the femoral vein and then removed through a small surgical opening of the vein or through aspiration of the bag, after which the device can be used again, if necessary.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Biophysics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgical Instruments (AREA)

Abstract

Le présent brevet d'invention relève du domaine de la santé et consiste en un un dispositif de retrait de thrombus (caillots sanguins) de l'intérieur de l'artère pulmonaire d'êtres humains adultes, comprenant un cathéter à trois lumières sur lequel est monté un ballonnet semi-expansible en forme d'anneau, appelé ballonnet-anneau, qui peut subir une expansion à partir de sa forme rétractée lors de son gonflage avec une solution saline, injectée par l'intermédiaire de deux lumières du cathéter, le ballonnet-anneau présentant, fixée à son bord externe, l'embouchure d'un sachet conique dont le maillage permet le passage du sang mais pas des thrombus, constituant conjointement avec le ballonnet-anneau un objet ressemblant à une manche à air dont la fonction est de capturer les thrombus, trois fils assurant l'assujettissement du ballonnet-anneau sur le cathéter et servant de moyens pour tirer et recueillir le ballonnet-anneau vers l'intérieur d'une gaine, après capture des thrombus.
PCT/BR2021/050573 2021-11-24 2021-12-22 Dispositif endovasculaire de capture et d'élimination de thrombus WO2023092200A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BRBR102021023636-1 2021-11-24
BR102021023636-1A BR102021023636A2 (pt) 2021-11-24 Dispositivo endovascular de captura e remoção de trombos

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WO2023092200A1 true WO2023092200A1 (fr) 2023-06-01

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8956385B2 (en) * 2009-04-14 2015-02-17 Aharon FRIMERMAN Integrated distal embolization protection apparatus for endo-luminal devices such as balloon, stent or tavi apparatus
WO2017074530A1 (fr) * 2015-10-26 2017-05-04 Sos Thomas A Extraction de thrombus et dispositif de protection distal intravasculaire contre l'embolie
US9999493B2 (en) * 2015-08-06 2018-06-19 Kp Medcure, Inc. Axial lengthening thrombus capture system
US20210128185A1 (en) * 2019-11-05 2021-05-06 Kp Medcure, Inc. Axial lengthening thrombus capture system, tensioning system and expandable funnel catheter

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8956385B2 (en) * 2009-04-14 2015-02-17 Aharon FRIMERMAN Integrated distal embolization protection apparatus for endo-luminal devices such as balloon, stent or tavi apparatus
US9999493B2 (en) * 2015-08-06 2018-06-19 Kp Medcure, Inc. Axial lengthening thrombus capture system
WO2017074530A1 (fr) * 2015-10-26 2017-05-04 Sos Thomas A Extraction de thrombus et dispositif de protection distal intravasculaire contre l'embolie
US20210128185A1 (en) * 2019-11-05 2021-05-06 Kp Medcure, Inc. Axial lengthening thrombus capture system, tensioning system and expandable funnel catheter

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