WO2017118920A1 - Dispositif de coupe avec enclume expansible - Google Patents

Dispositif de coupe avec enclume expansible Download PDF

Info

Publication number
WO2017118920A1
WO2017118920A1 PCT/IB2017/050011 IB2017050011W WO2017118920A1 WO 2017118920 A1 WO2017118920 A1 WO 2017118920A1 IB 2017050011 W IB2017050011 W IB 2017050011W WO 2017118920 A1 WO2017118920 A1 WO 2017118920A1
Authority
WO
WIPO (PCT)
Prior art keywords
anvil
cutting
distal
cutting device
blade
Prior art date
Application number
PCT/IB2017/050011
Other languages
English (en)
Inventor
Dan Rottenberg
Yossi PESIS
Original Assignee
Cardiopass Ltd.
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 Cardiopass Ltd. filed Critical Cardiopass Ltd.
Publication of WO2017118920A1 publication Critical patent/WO2017118920A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B2017/320064—Surgical cutting instruments with tissue or sample retaining means

Definitions

  • the present invention generally relates to tissue cutting devices, and particularly to a cutting device with an expandable anvil for cutting holes, for example, in an atrium wall to reduce elevated filling pressure incurred by cardiac dysfunction to an acceptable level that provides adequate left ventricle function, while reducing the left atrium and pulmonary venous pressures below the point where pulmonary congestion occurs.
  • Congestive heart failure is a syndrome characterized by left ventricular dysfunction, reduced exercise tolerance, impaired quality of life and dramatically shortened life expectancy. Decreased contractility of the left ventricle leads to reduced cardiac output with consequent systemic arterial and venous vasoconstriction.
  • CHF develops generally in the course of months or years, and can be the end stage of chronic hypertension, infarction, angina, or diabetes.
  • pharmacological e.g., diuretics
  • assist systems e.g., pumps
  • surgical treatments e.g., pharmacological treatments
  • diuretics have been used to reduce the workload of the heart by reducing blood volume and preload.
  • Assist devices used to treat CHF include, for example, mechanical pumps.
  • Mechanical pumps reduce the load on the heart by performing all or part of the pumping function normally done by the heart.
  • mechanical pumps are used to sustain the patient while a donor heart for transplantation becomes available for the patient.
  • pacing devices used to treat CHF.
  • high rate pacing may lead to increased diastolic pressure, indicating calcium overload and damage of the muscle fibers.
  • a conduit may be positioned in a hole in the atrial septum of the heart to allow flow from the left atrium into the right atrium. Shunting the blood may reduce left atrial pressures, thereby preventing pulmonary edema and progressive left ventricular dysfunction, and reducing LVEDP.
  • A) Use the Seldinger technique to puncture the tissue with a needle, and then use several dilators to increase the puncture size. Balloons may also be used to increase the orifice diameter. Since no tissue is removed, the Seldinger method is used to insert catheters for short percutaneous heart treatment like RF ablation, or to open a blood path between the heart atriums when leaving an implant to keep the orifice open, as such unobstructed orifice/hole will close very quickly as the tissue elasticity tends to regain its original shape.
  • the present invention seeks to provide devices and methods for reducing elevated filling pressure, e.g., incurred by cardiac dysfunction, to acceptable levels, while still providing adequate left ventricle function, and reducing the left atrium and pulmonary venous pressures below the point where pulmonary congestion occurs.
  • elevated filling pressure e.g., incurred by cardiac dysfunction
  • the invention may be applicable to treat several disorders, such as without limitation, increased left atrium pressure (LAP) that occurs as part of Congestive Heart Failure (CHF).
  • LAP left atrium pressure
  • CHF Congestive Heart Failure
  • a device and method are provided for cutting an orifice in the atrium wall between the right and left atriums, preferably at the fossa-ovalis section of the atrial wall.
  • Such a large orifice reduces elevated left atrium pressure by allowing blood flow directly from the left atrium into the right atrium.
  • a catheter-based device is used to mechanically cut an orifice in the atrial septum wall and remove the cut tissue in one piece from the septum wall (and afterwards out from the body).
  • the orifice cutting catheter may cut a large orifice from the atrium septum wall in one catheter activation. The cut tissue is locked inside the catheter and removed from the body when removing the catheter.
  • the orifice cutting catheter of the invention may be adjustable to cut different orifice diameters.
  • the cutting mechanism may include a specially shaped blade or other hand activated mechanical cutting mechanism.
  • the blade may be round (e.g., circular) and may move relative to an anvil or anvils.
  • the catheter distal anvil is preferably an expandable anvil.
  • This distal anvil may pass the atrial septum through a small diameter puncture, and then expand to its full size (full diameter) to fit the cutting mechanism diameter.
  • the diameter of the temporary hole created is unknown at the time the device of the invention is used, usually shortly after the puncture is performed, as the hole created by the sheath or balloon may still be completely or partially open at the time of septum cutting by the catheter of the invention, so it might cut nothing or just small portion of the septum tissue, instead of a full round tissue disk as required.
  • the orifice is preferably cut in a smooth, round shape, without any jagged edges or bulges that might disturb blood flow.
  • the round cutting blade may be connected to an RF energy source, using the round blade as an RF electrode, to allow cutting a round large opening in the atrial septum.
  • the orifice cutting catheter of the invention may be coated with substances, such as but not limited to, Paclitaxel drug used in drug eluting balloons, to prevent cell growth at the edges of the orifice.
  • substances such as but not limited to, Paclitaxel drug used in drug eluting balloons, to prevent cell growth at the edges of the orifice.
  • the present invention describes, inter alia, methods and apparatus for decreasing pressure in the left side of the cardiac structure of a patient by opening an orifice or a shunt communicating with an area on both left and right sides of the heart atriums, whereby a volume of blood sufficient to reduce pressure in the left atrium is released from one atrium to the other.
  • Fig. 1 is a schematic illustration of the heart chambers and the atrial septum.
  • Fig. 2 is a schematic illustration of a cutting device in accordance with a non- limiting embodiment of the present invention, with a distal anvil penetrating the atrial septum.
  • Fig. 3 is a sectional schematic illustration of heart chambers with a hole in the atrial septum made with the device of the invention.
  • Fig. 4 is a simplified illustration of the device of the invention with a proximal handle, control knobs and a distal balloon-expandable anvil.
  • Fig. 5 is a further illustration of the device of the invention with a balloon- expandable anvil.
  • Fig. 6 is a simplified schematic illustration of the device of the invention after penetrating the atrial septum, before opening the balloon anvil.
  • Fig. 7 is a simplified schematic illustration of the device of the invention after penetrating the atrial septum, opening the balloon-expandable anvil, and pulling the balloon backwards towards the septum.
  • Fig. 8 is a simplified schematic illustration of locking the septum tissue between the two anvils.
  • Fig. 9 is a simplified sectional schematic illustration of the device of the invention after cutting the hole in the atrial septum, keeping the cut tissue within the catheter tip.
  • Fig. 10 is a simplified sectional schematic illustration of the device of the invention, in accordance with another non-limiting embodiment of the present invention, having a self-expandable distal anvil (e.g., made from a shape memory material) in its contracted, non-expanded position.
  • a self-expandable distal anvil e.g., made from a shape memory material
  • Fig. 11 is a simplified sectional schematic illustration of the device of Fig. 10, with the self-expandable distal anvil in its expanded position.
  • FIG. 1 illustrates pertinent parts of the cardiovascular anatomy. Shown are a large peripheral vein 9 next to the right atrium 5, and the atrial septum 4 that separates the right atrium 5 from the left atrium 6.
  • Cutting device 1 which may be delivered over a guidewire 2, includes a cutting assembly 33, which may be located at a distal portion 31 of a working shaft 34.
  • a distal anvil 32 is located distally of cutting assembly 33 on an anvil shaft 39.
  • a proximal anvil 42 is located near cutting assembly 33. In one embodiment, proximal anvil 42 is arranged to be concentric with, and moved inwards of, cutting assembly 33.
  • the device 1 may be delivered to the right atrium 5 by passing over guidewire 2.
  • the guidewire 2 passes from the right atrium 5 through the atrial septum 4 into the left atrium 6.
  • the distal anvil 32 while in the contracted orientation, passes into the left atrium 6 through the opening formed in the septum 4 by guidewire 2.
  • the distal anvil 32 is then expanded.
  • the proximal anvil 42 and the distal anvil 32 are brought towards each other so as to clamp septum 4. While the septum 4 is clamped, cutting assembly 33 may then be used to cut an aperture 7 (Fig. 3) in septum 4.
  • Cutting device 1 may include a proximal handle 35 with one or more control knobs 40 and 41.
  • a flexible shaft 34 extends distally from handle 35.
  • the cutting assembly 33 may be located at distal portion 31 of shaft 34.
  • Distal anvil 32 is located distally of cutting assembly 33 on anvil shaft 39.
  • a guidewire lumen 37 may extend distally of distal anvil 32.
  • FIG. 6 illustrates one application of cutting device 1, namely, to cut an aperture in the atrial septum 4 (e.g., at or near the fossa ovalis 8, to allow blood to flow through the aperture between the left and right atriums.
  • This helps reduce elevated filling pressure incurred by cardiac dysfunction, to an acceptable level that provides adequate left ventricle function, while reducing the left atrium and pulmonary venous pressures below the point where pulmonary congestion occurs.
  • Cutting device 1 may be delivered to the right atrium by passing over guidewire 2.
  • the guidewire 2 passes from the right atrium through the atrial septum 4 into the left atrium.
  • the distal anvil 32 while in the contracted orientation and mounted on anvil shaft 39, passes into the left atrium through the opening formed in the septum 4 by guidewire 2.
  • the proximal anvil 42 is on the proximal side of the septum 4 in the right atrium.
  • the distal anvil 32 is then expanded, such as by expanding a balloon, next to or connected to, distal anvil 32.
  • the portion of anvil 32 which expands is designated in the drawings by numeral 38.
  • the balloon may form part of or all of distal anchor 32.
  • the balloon may be expanded by introducing fluid thereto, as is well known in the art.
  • proximal anvil 42 and the distal anvil 32 are brought towards each other so as to clamp septum 4.
  • the atrium fossa tissue is very thin and flexible, and moves as the heart beats. Therefore in order to cut the aperture, the atrium fossa must be held tight. On the other hand, it is dangerous to apply uncontrolled pressure on the tissue as it may tear completely or in an uncontrolled shape.
  • the invention solves these problems by the clamping action of the two anvils.
  • proximal anvil 42 is arranged to be concentric with blade 36 of cutting assembly 33.
  • the cutting assembly may be moved over proximal anvil 42.
  • the rotating round blade 36 may have a uniform, sharp cutting edge, or multiple cutting teeth.
  • Blade 36 may move relative to distal and proximal anvils 32 and 42 to cleanly cut a circular hole in the atrial septum 4.
  • the blade may be moved manually, semi-automatically or automatically by the control button or buttons. In the automatic mode, a motor or other suitable actuator may be used to rotate blade 36.
  • the cut hole perimeter is free of burrs and ragged edges.
  • the cut material is entrapped between the two anvils and covered by cutting assembly 33, so that no dangerous debris is left to flow in the vasculature.
  • the cut material is removed from the body upon removal of the device from the body.
  • the cut aperture size may be a few millimeters in diameter, in the range between 2 mm to 10 mm, and more preferably between 5-8 mm in diameter.
  • the aperture is not limited in size or shape (e.g., may be oval or non-round).
  • blade 36 may be connected to an RF energy source 50 (Fig. 4) so that blade 36 serves as an electrode to cut the tissue by RF ablation.
  • the tissue may vaporize during ablation, minimizing risk of debris entering the vasculature.
  • the RF ablation/cutting may be combined with mechanical cutting of the blade or other blade.
  • the blade may operate in bipolar, monopolar or combined monopolar and bipolar mode.
  • the distal anchor 32 may include a flexible conductive ring 44 printed at its proximal base, as known in the art for electrodes printing over balloons used in ablation catheters. Flexible ring 44 may be connected to the second pole of the bipolar RF energy source 50, while blade 36 (in the form of a ring) may be connected to the first lead of the bipolar RF energy RF energy source 50.
  • the distal anchor 32 and the blade 36 may operate as bipolar electrodes.
  • a distal self-expandable anvil 52 is made from a shape memory material (e.g., nitinol), such as from wires or wire mesh 51.
  • the self-expandable anvil 52 may be initially collapsed inside anvil shaft 39 while penetrating through the atrial septum. After passing from the right atrium into the left atrium, the wires 51 may be deployed and expanded out the shaft 29 to regain the shape of the distal anchor 52 as seen in Fig. 11. The device is then used as described before.
  • the cutting blades 36 and anvils 32 and/or 42 may be coated with drugs (e.g., Paclitaxel) used in drug eluting balloons, to prevent cell growth at the edges of the orifice.
  • drugs e.g., Paclitaxel
  • the working shaft 34 may have a pre- bended tip or deflected tip mechanism using a pulling wire or other bending mechanism, in order to aim the distal tip 31 of device towards the atrial septum.

Abstract

Un dispositif de coupe (1) comprend un ensemble de coupe (33) situé sur un arbre de travail (34) et en communication fonctionnelle avec une poignée (35). Une enclume expansible distale (32) et une enclume proximale (42) sont situées de manière amovible sur un arbre d'enclume (39) qui s'étend de façon distale de l'arbre de travail (34). L'enclume distale (32) et l'enclume proximale (42) peuvent être rapprochées et écartées l'une de l'autre. L'ensemble de coupe (33) comprend une lame de coupe (36) opérationnelle pour découper le tissu clampé entre l'enclume distale (32) et l'enclume proximale (42).
PCT/IB2017/050011 2016-01-04 2017-01-03 Dispositif de coupe avec enclume expansible WO2017118920A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662274433P 2016-01-04 2016-01-04
US62/274,433 2016-01-04

Publications (1)

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WO2017118920A1 true WO2017118920A1 (fr) 2017-07-13

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Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10828151B2 (en) 2009-05-04 2020-11-10 V-Wave Ltd. Devices for reducing left atrial pressure, and methods of making and using same
US10898698B1 (en) 2020-05-04 2021-01-26 V-Wave Ltd. Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
US10912645B2 (en) 2004-02-03 2021-02-09 V-Wave Ltd. Device and method for controlling in-vivo pressure
US10925706B2 (en) 2009-05-04 2021-02-23 V-Wave Ltd. Shunt for redistributing atrial blood volume
US10940296B2 (en) 2015-05-07 2021-03-09 The Medical Research, Infrastructure and Health Services Fund of the Tel Aviv Medical Center Temporary interatrial shunts
US11109988B2 (en) 2016-05-31 2021-09-07 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11135054B2 (en) 2011-07-28 2021-10-05 V-Wave Ltd. Interatrial shunts having biodegradable material, and methods of making and using same
US11234702B1 (en) 2020-11-13 2022-02-01 V-Wave Ltd. Interatrial shunt having physiologic sensor
US11253353B2 (en) 2006-01-23 2022-02-22 V-Wave Ltd. Heart anchor device
US11291807B2 (en) 2017-03-03 2022-04-05 V-Wave Ltd. Asymmetric shunt for redistributing atrial blood volume
US11304831B2 (en) 2016-05-31 2022-04-19 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11304753B2 (en) 2019-09-13 2022-04-19 Alleviant Medical, Inc. Systems, devices, and methods for forming an anastomosis
US11458287B2 (en) 2018-01-20 2022-10-04 V-Wave Ltd. Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
US11612385B2 (en) 2019-04-03 2023-03-28 V-Wave Ltd. Systems and methods for delivering implantable devices across an atrial septum
US11690976B2 (en) 2013-05-21 2023-07-04 V-Wave Ltd. Apparatus and methods for delivering devices for reducing left atrial pressure
US11744589B2 (en) 2018-01-20 2023-09-05 V-Wave Ltd. Devices and methods for providing passage between heart chambers
US11813386B2 (en) 2022-04-14 2023-11-14 V-Wave Ltd. Interatrial shunt with expanded neck region
US11850138B2 (en) 2009-05-04 2023-12-26 V-Wave Ltd. Shunt for redistributing atrial blood volume
US11865282B2 (en) 2019-05-20 2024-01-09 V-Wave Ltd. Systems and methods for creating an interatrial shunt

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US20140081305A1 (en) * 2012-09-06 2014-03-20 Indian Wells Medical, Inc. Hollow Organ Coring Tool with Collapsing Anvil and Method of Use
US20140228843A1 (en) * 2009-04-06 2014-08-14 Michael J. O'Donnell System and method for resecting a valve
US20140277045A1 (en) * 2013-03-12 2014-09-18 Dc Devices, Inc. Devices, systems, and methods for treating heart failure
US20150359556A1 (en) * 2014-06-13 2015-12-17 InterShunt Technologies, Inc. Method and catheter for creating an interatrial aperture

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US20130006281A1 (en) * 1999-04-05 2013-01-03 Medtronic, Inc. Apparatus and Methods for Anastomosis
US20140228843A1 (en) * 2009-04-06 2014-08-14 Michael J. O'Donnell System and method for resecting a valve
US20140081305A1 (en) * 2012-09-06 2014-03-20 Indian Wells Medical, Inc. Hollow Organ Coring Tool with Collapsing Anvil and Method of Use
US20140277045A1 (en) * 2013-03-12 2014-09-18 Dc Devices, Inc. Devices, systems, and methods for treating heart failure
US20150359556A1 (en) * 2014-06-13 2015-12-17 InterShunt Technologies, Inc. Method and catheter for creating an interatrial aperture

Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11382747B2 (en) 2004-02-03 2022-07-12 V-Wave, Ltd. Device and method for controlling in-vivo pressure
US10912645B2 (en) 2004-02-03 2021-02-09 V-Wave Ltd. Device and method for controlling in-vivo pressure
US11266501B2 (en) 2004-02-03 2022-03-08 V-Wave Ltd. Device and method for controlling in-vivo pressure
US11253353B2 (en) 2006-01-23 2022-02-22 V-Wave Ltd. Heart anchor device
US10828151B2 (en) 2009-05-04 2020-11-10 V-Wave Ltd. Devices for reducing left atrial pressure, and methods of making and using same
US11850138B2 (en) 2009-05-04 2023-12-26 V-Wave Ltd. Shunt for redistributing atrial blood volume
US10925706B2 (en) 2009-05-04 2021-02-23 V-Wave Ltd. Shunt for redistributing atrial blood volume
US11135054B2 (en) 2011-07-28 2021-10-05 V-Wave Ltd. Interatrial shunts having biodegradable material, and methods of making and using same
US11690976B2 (en) 2013-05-21 2023-07-04 V-Wave Ltd. Apparatus and methods for delivering devices for reducing left atrial pressure
US10940296B2 (en) 2015-05-07 2021-03-09 The Medical Research, Infrastructure and Health Services Fund of the Tel Aviv Medical Center Temporary interatrial shunts
US11304831B2 (en) 2016-05-31 2022-04-19 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11109988B2 (en) 2016-05-31 2021-09-07 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11497631B2 (en) 2016-05-31 2022-11-15 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11607327B2 (en) 2016-05-31 2023-03-21 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11291807B2 (en) 2017-03-03 2022-04-05 V-Wave Ltd. Asymmetric shunt for redistributing atrial blood volume
US11458287B2 (en) 2018-01-20 2022-10-04 V-Wave Ltd. Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
US11744589B2 (en) 2018-01-20 2023-09-05 V-Wave Ltd. Devices and methods for providing passage between heart chambers
US11612385B2 (en) 2019-04-03 2023-03-28 V-Wave Ltd. Systems and methods for delivering implantable devices across an atrial septum
US11865282B2 (en) 2019-05-20 2024-01-09 V-Wave Ltd. Systems and methods for creating an interatrial shunt
US11304753B2 (en) 2019-09-13 2022-04-19 Alleviant Medical, Inc. Systems, devices, and methods for forming an anastomosis
US11612432B2 (en) 2019-09-13 2023-03-28 Alleviant Medical, Inc. Systems, devices, and methods for forming an anastomosis
US11871987B2 (en) 2019-09-13 2024-01-16 Alleviant Medical, Inc. Systems, devices, and methods for forming an anastomosis
US10898698B1 (en) 2020-05-04 2021-01-26 V-Wave Ltd. Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
US11234702B1 (en) 2020-11-13 2022-02-01 V-Wave Ltd. Interatrial shunt having physiologic sensor
US11813386B2 (en) 2022-04-14 2023-11-14 V-Wave Ltd. Interatrial shunt with expanded neck region

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