WO2013068466A1 - Système pour l'occlusion d'un appendice atrial gauche - Google Patents

Système pour l'occlusion d'un appendice atrial gauche Download PDF

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Publication number
WO2013068466A1
WO2013068466A1 PCT/EP2012/072145 EP2012072145W WO2013068466A1 WO 2013068466 A1 WO2013068466 A1 WO 2013068466A1 EP 2012072145 W EP2012072145 W EP 2012072145W WO 2013068466 A1 WO2013068466 A1 WO 2013068466A1
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WO
WIPO (PCT)
Prior art keywords
balloon
inner space
catheter
designed
fluid
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Application number
PCT/EP2012/072145
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English (en)
Inventor
Rolf Jenni
Barbara STÄHLI
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Universität Zürich
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Publication of WO2013068466A1 publication Critical patent/WO2013068466A1/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
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/12186—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices liquid materials adapted to be injected
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/063—Measuring instruments not otherwise provided for for measuring volume
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image

Definitions

  • the invention relates to a system (or device) for occluding a left atrial appendage (denoted also as LAA in the following) of a human heart according to the preamble of claim 1 . Further, the invention relates to a method for inflating a balloon, particularly of a system according to the invention.
  • Such a system comprises an expandable (deployable) element being designed to be inserted into said LAA of a human heart in a first state of said element, wherein said element is further designed to be expanded from said first state into a second state in which said element occludes said LAA.
  • Atrial fibrillation is the most frequent cardiac arrhythmia worldwide. It predisposes to atrial thrombus formation thereby increasing the risk for embolic events.
  • oral anticoagulation is the standard treatment for prevention of embolic events. Although effective when used appropriately, oral anticoagulation is burdened by a narrow therapeutic window, pharmacological interactions, and life-threatening bleeding complications, especially in a frail, elderly patient population. Hence, oral anticoagulation is often underused in clinical practice, and contraindications for oral anticoagulation are frequently given (cf. Brass LM, Krumholz HM, Scinto JM, Radford M, Warfarin use among patients with atrial fibrillation, Stroke 1997; 28: 2382-9).
  • LAA removal or occlusion seems to be an appealing option for stroke prevention for high-risk patients with contraindications concerning oral anticoagulation.
  • Different techniques for surgical obliteration mainly in conjunction with mitral valve surgery or as an adjunct to the Maze procedure, as well as devices for percutaneous LAA occlusion have been developed. Surgical techniques are invasive and are rarely performed as stand-alone procedures.
  • Percutaneous LAA occlusion was first reported in 2002 by Sievert et al. ( cf. Sievert H, Lesh MD, Trepels T, et al., Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience, Circulation 2002; 105: 1887-9).
  • the procedure is performed under fluoroscopic or transesophageal echocardiographic guidance via a transfemoral transvenous approach and provides a promising less invasive treatment option in stroke prevention.
  • the PLAATO device was the first device used for percutaneous LAA occlusion in patients with chronic atrial fibrillation and contraindications to oral anticoagulation. It consists of a self- expandable nitinol cage covered with an expanded polytetrafluoroethylene membrane. Different sizes are available to ensure optimal sealing (15-32 mm) (cf. Ostermayer SH, Reisman M, Kramer PH, et al., Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials, J Am Coll Cardiol 2005; 46: 9-14).
  • the Watchman device is another device used for LAA occlusion, made of a self- expandable nitinol frame covered with a 160 ⁇ filter polyester membrane (cf. Fountain RB, Holmes DR, Chandrasekaran K, et al., The PROTECT AF (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients with Atrial Fibrillation) trial, Am Heart J 2006; 151 : 956-61 ).
  • the Amplatzer occluder device designed for atrial and ventricular septal defect and patent foramen ovale closures, or more recently the Amplatzer Cardiac Plug device (disc size 20-36 mm) are also used for LAA occlusion (cf.
  • the LAA is nowadays considered a key player in regulating fluid and electrolyte hemostasis.
  • atrial appendages secrete different peptides in response to atrial distention such as atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP).
  • ANP atrial natriuretic peptide
  • BNP brain natriuretic peptide
  • surgical biatrial appendage exclusion significantly reduces ANP and BNP levels.
  • the main disadvantage of current commercially available percutaneous LAA occlusion devices is, that they stretch and distend the LAA. It seems thereby conceivable, that atrial stretch distorts cellular function, and increases the levels of ANP and BNP. Alterations which might influence fluid and electrolyte balance in the postoperative course.
  • the problem underlying the present invention is to provide for a system for occluding a LAA that prevents the LAA from distention.
  • said element in order to occlude the LAA, is designed to fill in the LAA completely in a form-fitting manner in said second state without acting on an inner side of the LAA with a pressure that tends to permanently deform the shape of the LAA.
  • the expandable element in conjunction with the system (or device) according to the invention is adapted to be filled and thereby to expand such that it exactly fills the LAA without stretching or distending it.
  • the expandable element is designed as an inflatable (unfoldable) balloon that encloses an inner space of said balloon, wherein said balloon is designed to be expanded by filling said inner space with a first fluid, particularly in the form of a sodium chloride solution.
  • a first fluid particularly in the form of a sodium chloride solution.
  • said balloon is preferably folded in the first (collapsed) state, in which the balloon occupies a first volume that is comparatively small, so that the folded (collapsed) balloon has the proper dimensions for percutaneous insertion and delivery through vasculatures of the respective person (for instance via a transfemoral approach).
  • the balloon Upon feeding said fluid into the inner space of the inflatable balloon, the balloon unfolds (deploys) into its final second state in which the balloon tightly butts against an inner side of the LAA facing an outer side of the balloon.
  • the system comprises a (delivery) catheter, wherein the expandable element is releasably connected to a free end region of said catheter, for instance via a connecting element (connector) that is designed to release the expandable element by operating the catheter outside the persons body in a certain way, for instance by rotating the catheter about its longitudinal axis along which the catheter extends.
  • the catheter defines at least one conduit being in fluid connection with the inner space of the inflatable balloon, such that the balloon can be inflated by means of said fluid via the catheter.
  • the system comprises a means designed to measure this pressure, wherein said means preferably comprises a manometer that is designed to be (releasably) connected to said catheter.
  • said means preferably comprises a manometer that is designed to be (releasably) connected to said catheter.
  • the catheter, parts of the catheter and/or said balloon (expandable element) may form a pressure pick-up. It is also conceivable to arrange some other pressure sensor at or in (or near) the free end of the catheter that allows to determine said pressure.
  • the system comprises a corresponding means that is designed to push said fluid through the catheter.
  • said means can be formed by a first syringe that is configured to be (releasably) connected to the catheter.
  • the first syringe may be operated manually in order to push the fluid into the inflatable balloon via the catheter.
  • the system preferably also comprises a means for measuring the pressure in the inner space of said balloon, wherein said means particularly comprises a manometer that is designed to be (releasably) connected to said catheter. Said manometer or said means may also be used to measure the pressure inside the left atrium as described above.
  • the system therefore preferably comprises a means that is designed to pump the first fluid via said catheter out of the inner space of the balloon, wherein particularly said means is designed to be (releasably) connected to the catheter.
  • said means may be formed by the means that is also used for pumping the fluid into the inflatable balloon (e.g. first syringe).
  • the system preferably comprises a means for measuring the said amount (volume) of the fluid that was fed (pumped) into the inner space of the balloon or removed from the inner space of the balloon.
  • this means is also formed by said first syringe, which may comprise a scale for measuring said amount (volume) on a tube of the first syringe, in which tube a plunger for pushing the fluid out of the tube of said first syringe is guided.
  • a hardening substance is introduced into the inner space of the balloon via the catheter.
  • the hardening substance may be introduced into the inner space of the balloon as a complete mixture of two components.
  • the components of said hardening substance may be introduced into said inner space separately so that they mix in said inner space of the balloon for the first time.
  • the system further preferably comprises a means that is designed to position said hardening substance in the inner space of the balloon via the catheter, such that said substance causes the balloon to butt against the inner side of the LAA in a form- fitting manner, such that the balloon is anchored in the LAA in a form-fitting manner after hardening (curing) of said substance, wherein particularly said means is designed to be (releasably) connected to the catheter, and wherein said hardening substance is designed to harden after a pre-determined time or after being introduced into the inner space of the inflatable balloon.
  • said means may be formed by a second syringe.
  • said hardening substance (fluid) comprises at least a first and a second component, wherein the first component is particularly formed by glutaraldehyde, and wherein the second component is particularly formed by purified bovine serum albumin.
  • said means is designed to feed (pump) the two components via the catheter into the inner space of the inflatable balloon.
  • said means may be designed to pump the two components via said (single) conduit into the inner space of the inflatable balloon, namely at the same time, such that said components mix in said conduit in order to form the hardening substance.
  • the catheter may define a separate first conduit for the first component and a separate second conduit for the second component, wherein said means is designed to pump the first component via the first and the second component via the second conduit into the inner space of the inflatable balloon (at the same time) such that the two components mix in said inner space in order to form the hardening substance.
  • the hardening substance may be formed by blood (e.g. as a first component or part of a first component) or may comprise blood, particularly innate blood (i.e. of the respective patient), which may be taken before actually filling the balloon in the LAA with this hardening substance.
  • the blood will then coagulate and thus harden the balloon.
  • the coagulation may be accelerated by using a blood coagulation factor (e.g. tissue factor) as a second component or as part of a second component.
  • a blood coagulation factor e.g. tissue factor
  • the catheter used to deliver said expandable element (inflatable balloon) to the LAA comprises a three-way-valve for connecting the above described means (syringes and manometers) to said catheter.
  • the device or system described above may be percutaneously delivered to the left (and eventually also to the right) atrial appendage.
  • the catheter and/or the expandable element inflatable balloon
  • the catheter and/or the expandable element may comprise a material which allows for or improves visualization or imaging of the delivery process by ultrasound, x-ray (fluoroscopic guidance) or any other means, such that the expandable element can be precisely positioned in the respective atrial appendage.
  • the invention relates to a method for inflating an expandable element (balloon) having the features of claim 19.
  • the method comprises the steps of: Feeding (e.g. pumping) a fluid into an inner space of said balloon, which was pre-inserted into the LAA in beforehand, wherein said inner space is filled with said fluid such that the pressure inside the balloon (in its inner space) corresponds to the pressure in the left atrium (determined in beforehand), removing the fluid from the balloon, measuring the volume (amount) of the fluid that was filled into the balloon (or removed from said balloon), wherein the volume (amount) of said fluid may also be measured upon filling the fluid into said inner space, and positioning a volume (an amount) of a hardening substance (or the components of such a substance) in the inner space of said balloon, which hardening substance is designed to harden after being filled into the balloon, wherein said volume (amount) of the hardening substance is equal to the measured volume (amount) of the fluid (e.g. a sodium chloride solution, see above).
  • the hardening substance is a glue or innate blood (see above) or another suitable
  • Figure 1 shows a schematical view of a device (system) according to the invention for occluding a LAA
  • Figure 2 shows a schematical, cross-sectional view of a LAA, into which an occluder according to the invention is arranged by a transfemoral approach.
  • the invention relates to an inflatable balloon device 1 for permanent LAA occlusion designed to overcome the above mentioned disadvantages of current designs consisting predominantly of discs or membranes.
  • the LAA 2 lies within the pericardium in close contact with the free wall of the left ventricle.
  • the LAA 2 empties into the left atrium 7 of the heart through an orifice located between the left upper pulmonary vein and the left ventricle.
  • the diameter of the opening may vary between 10 and 40 mm, the overall volume of the LAA may vary between 0.8 and 19.3 cubic centimeters, and its length can vary between 16 and 51 mm.
  • the inflatable balloon device 1 as shown in figure 2 is constructed in a manner that it is easily insertable into the human body and positionable into the LAA 2. Due to its simple design this invention is a cost-effective, easy applicable, and secure solution for percutaneous LAA occlusion without putting any stretch on the LAA 2.
  • the device (system) 1 comprises the following parts: an expandable element, preferably in the form of an inflatable balloon 10 that encloses an inner space I, which balloon 10 is adapted for filling the complete LAA volume, a connector (connecting element) 20 fixing the balloon 10 to a catheter 30, which allows inflation of the balloon 10 with a fluid, e.g. a physiological solution like a sodium chloride solution, and subsequently with a hardening substance, wherein said connector 20 further allows for releasing the balloon 10 from the catheter 30, and finally said delivery catheter 30 being designed to guide the balloon 10 and to inflate the balloon 10.
  • a fluid e.g. a physiological solution like a sodium chloride solution
  • the delivery catheter 30 with the collapsed (folded) balloon 10 on its tip (free end 30a) is introduced by a transfemoral approach, in which the catheter 30 enters the heart from the femoral vein, passes through the inferior vena cava 3 to the right atrium 4 and then passes through the interatrial septum behind the aortic root 6 into the left atrium 7 and then approaches the LAA 2.
  • the balloon 10 has a diameter W of 6 to 10 French (1 French corresponds to 1/3 mm) in the collapsed non-inflated first state to allow for a percutaneous implantation of the catheter/balloon 30, 10.
  • a manometer 52 may be connected, for instance via a three-way-valve 40, to the catheter 30, wherein the catheter 30 and/or balloon 10 may act as a pressure pick-up. Other pressure sensors may also be applied.
  • the balloon 10 is then arranged in the LAA 2 and a physiological solution is injected into the delivery catheter 30 by means of a first syringe 50 connected to the catheter 30 via said three-way-valve 40, for instance, to inflate the balloon 10 until the balloon inflation pressure approximately corresponds to the pressure measured within the left atrium 7.
  • Said balloon inflation pressure inside the inner space I of the balloon 10 may also be measured by means of said manometer 52 connected to the catheter 30 via said valve 40 or by means of some other appropriate pressure sensor.
  • this fluid physiological solution, e.g. sodium chloride solution
  • this fluid will be removed and the volume of the solution will be measured, for instance by means of a scale given on the first syringe 50.
  • the same volume of a hardening substance is then injected into the delivery catheter 30 by means of a second syringe 51 , for instance, which may also be connected to the catheter via said three-way-valve 40.
  • This hardening substance will fill in the whole LAA 2 and will solidify during the next seconds to minutes.
  • the hardening substance material
  • the balloon 10 is anchored in the LAA 2.
  • the whole LAA 2 is filled with the balloon 10, it is completely excluded from the circulation and thrombus formation is prevented.
  • the delivery catheter 30 is detached from the connector 20 and removed from the body of the patient.
  • the balloon 10 consists of a biocompatible compliant material.
  • the hardening substance used may consist of 2 biocompatible glue components previously separated and dispensed by a controlled delivery system (e.g. BioGlue, CryoLife, Inc, Kennesaw, GA, US).
  • a controlled delivery system e.g. BioGlue, CryoLife, Inc, Kennesaw, GA, US.
  • the adhesive components consisting e.g. of glutaraldehyde molecules and purified bovine serum albumin molecules are mixed, begin to polymerize, and reach their strength within seconds to minutes.
  • the hardening substance used may consist of an innate blood donation, taken just before filling of the balloon 10 in the LAA 2.
  • the blood coagulation will provide a naturally permanent filling of the balloon 10.
  • the hardening substance may consist of an innate blood donation as a first component and e.g. a coagulation factor (e.g. tissue factor) as a second component.
  • a coagulation factor e.g. tissue factor
  • LAA volumes of about 9 ⁇ 3 ml have been documented (Christiaens L, Varroud-Vial N, Ardilouze P, et al., Real three-dimensional assessment of left atrial and left atrial appendage volumes by 64-slice spiral computed tomography in individuals with or without cardiovascular disease, Int J Cardiol 2010;140:189-96).
  • a hardening substance e.g. said glue or blood
  • a hardening substance e.g. said glue or blood
  • LAA Left atrial appendage

Abstract

L'invention concerne un système (1) pour l'occlusion d'un appendice atrial gauche comprenant : un élément dilatable (10) conçu pour être inséré dans ledit appendice atrial gauche (2) dans un premier état dudit élément, ledit élément (10) étant en outre conçu pour être dilaté depuis le premier état dans un second état dans lequel ledit élément (10) occlut l'appendice atrial gauche (2). Selon l'invention, ledit élément (10) est conçu pour remplir complètement l'appendice atrial gauche (2) d'une manière épousant les formes dans ledit second état sans agir sur un côté interne (2a) de l'appendice atrial gauche (2) au moyen d'une pression. L'invention concerne en outre un procédé de gonflage dudit élément dilatable (10).
PCT/EP2012/072145 2011-11-09 2012-11-08 Système pour l'occlusion d'un appendice atrial gauche WO2013068466A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP11188490.4 2011-11-09
EP11188490 2011-11-09
EP12180145.0 2012-08-10
EP12180145 2012-08-10

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WO2013068466A1 true WO2013068466A1 (fr) 2013-05-16

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WO2016127078A1 (fr) * 2015-02-06 2016-08-11 Boston Scientific Scimed, Inc. Dispositifs d'occlusion
EP2861293A4 (fr) * 2012-06-19 2016-08-31 Subramaniam Chitoor Krishnan Appareil et méthode de traitement des saignements provenant de l'appendice auriculaire gauche
US10052168B2 (en) 2012-06-19 2018-08-21 Subramaniam Chitoor Krishnan Methods and systems for preventing bleeding from the left atrial appendage
WO2018218210A1 (fr) 2017-05-25 2018-11-29 Microvention, Inc. Systèmes d'occlusion adhésifs
US10405866B2 (en) 2014-04-25 2019-09-10 Flow MedTech, Inc Left atrial appendage occlusion device
CN111249561A (zh) * 2020-02-19 2020-06-09 林成菊 妇科用阴道肛肠灌洗治疗仪
US10856881B2 (en) 2014-09-19 2020-12-08 Flow Medtech, Inc. Left atrial appendage occlusion device delivery system
US11083819B2 (en) 2019-02-13 2021-08-10 Joseph A. Abboud Joint spacers
US11517319B2 (en) 2017-09-23 2022-12-06 Universität Zürich Medical occluder device
US11564692B2 (en) 2018-11-01 2023-01-31 Terumo Corporation Occlusion systems
US11832824B2 (en) 2013-12-20 2023-12-05 Terumo Corporation Vascular occlusion
US11944315B2 (en) 2019-09-26 2024-04-02 Universität Zürich Left atrial appendage occlusion devices

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* Cited by examiner, † Cited by third party
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EP2861293A4 (fr) * 2012-06-19 2016-08-31 Subramaniam Chitoor Krishnan Appareil et méthode de traitement des saignements provenant de l'appendice auriculaire gauche
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