WO2018118706A1 - Récupérateurs de caillot et procédés de déploiement - Google Patents

Récupérateurs de caillot et procédés de déploiement Download PDF

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Publication number
WO2018118706A1
WO2018118706A1 PCT/US2017/066789 US2017066789W WO2018118706A1 WO 2018118706 A1 WO2018118706 A1 WO 2018118706A1 US 2017066789 W US2017066789 W US 2017066789W WO 2018118706 A1 WO2018118706 A1 WO 2018118706A1
Authority
WO
WIPO (PCT)
Prior art keywords
clot
delivery tube
wire
net
deployment
Prior art date
Application number
PCT/US2017/066789
Other languages
English (en)
Inventor
Omar M. Lattouf
Original Assignee
Lattouf Omar M
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 Lattouf Omar M filed Critical Lattouf Omar M
Publication of WO2018118706A1 publication Critical patent/WO2018118706A1/fr
Priority to US16/410,912 priority Critical patent/US11737769B2/en

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
    • A61B17/22—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
    • 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
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • 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
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end

Definitions

  • the present invention relates generally to medical devices and methods, and more particularly, to devices and methods for mechanically removing unwanted occlusive material from a blood vessel.
  • Coronary vessels can become narrowed or occluded by plaque or thrombus causing myocardial infarction, angina, and other conditions.
  • a coronary stenosis can be formed by an atheroma, which is typically a harder, calcified substance that forms on the lumen walls of a blood vessel.
  • a stenosis can also be formed of a thrombus material, which is typically much softer than an atheroma, but can nonetheless cause restricted blood flow in the lumen.
  • a number of medical procedures have been developed to effect removal or displacement of plaque or thrombus from vessel walls to open a channel restoring blood flow.
  • Conventional catheter-based removal techniques include enzymatic dissolution of the stenotic lesion, such as with streptokinase, and energy-based ablation, for example, by radio frequency signals and lasers. Removal of a stenosis has also been achieved by thrombectomy or atherectomy. During thrombectomy and atherectomy, the stenosis is mechanically cut or abraded away from the vessel.
  • Complications can arise from stenosis removal procedures. Stenotic debris, once separated from the stenosis, can flow from the treatment site though the vessel and compromise blood flow at a location removed from the treatment site.
  • Various protection systems have been developed to prevent such debris from embolizing in a vessel following treatment.
  • One such technique includes shredding the debris into sufficiently small fragments such that they will not occlude vessels within the vasculature. However, it can be difficult to control the size of severed fragments, particularly for thrombi, which tend to dislodge in larger fragments than atheroma.
  • Another technique includes introducing negative pressure into the vessel during treatment to vacuum up dislodged stenotic debris. However, excessive negative pressure can cause the vasculature to collapse.
  • Yet another technique for eliminating incidental stenotic debris during treatment includes introducing a vascular filter distal from the stenosis before removal.
  • the filter can catch dislodged fragments of the stenosis as they flow downstream from the treatment site. Later, the vascular filter can be retrieved along with the caught debris after the removal of the stenosis at the treatment site is complete.
  • Such filters include various configurations of nets, baskets, and other capture mechanisms for grabbing stenotic debris.
  • low-profile delivery to and deployment of captures devices at a treatment site in a blood vessel can be difficult to achieve.
  • Many conventional designs are hindered by complex and cumbersome actuation mechanisms.
  • captured stenotic debris can become loose again during extraction and retrieval of the capture device, again posing a risk of becoming dangerous emboli.
  • the present invention provides medical devices and methods for removing harmful occlusive material, such as soft plaque, calcified plaque, thrombus, fibrin, clot, fatty tissue, etc., (generally referred to herein as "clot" material) from blood vessels and other body lumens
  • harmful occlusive material such as soft plaque, calcified plaque, thrombus, fibrin, clot, fatty tissue, etc.
  • Blood vessels including the coronary, pulmonary, and peripheral vasculature are often treated with catheter-based thrombectomy or atherectomy procedures.
  • Aspects of the present invention improve the reliability and efficacy of such procedures by enabling low-profile delivery of clot retrieval devices inside a blood vessel, and providing simple and reliable mechanisms for deploying and retrieving the same.
  • Various configurations of clot capture mechanisms are described herein for capturing and extracting clot material.
  • the present invention provides a set of catheters or tubes containing a collapsed or compressed clot capture net, funnel, and/or other clot capture mechanisms which may be advanced distally through a blood vessel and past a clot region by a deployment wire. Once in place, the deployment wire is retracted proximally, deploying the expanding clot capture mechanism which then entrains and captures clot material as the device is removed from the vasculature.
  • the present invention provides a method for retrieving clot from a blood vessel.
  • the method includes advancing a wire delivery tube or catheter in a distal direction through a blood vessel or other body lumen toward and past a clot region in the blood vessel.
  • the blood vessel is a typically a coronary artery, peripheral vein, or peripheral artery, but can also be other types of vasculature such as renal, carotid, pulmonary artery, or the like.
  • the method further includes advancing a deployment wire in a distal direction from a distal end of the wire delivery tube or catheter, causing a collapsible hoop integrally formed in the distal end of the deployment wire to deploy laterally relative to a longitudinal axis of the deployment wire as the collapsible hoop emerges from the wire delivery tube.
  • the method further includes drawing or retracting the deployment wire in a proximal direction to pass the deployed hoop over and past the region of clot.
  • the deployed hoop pulls an attached clot collection net other capture mechanism which entrains and moves the clot from the region as the deployment wire is drawn proximally.
  • advancing the deployment wire in a distal direction further deploys a funnel attached to the deployment wire.
  • the funnel is aligned on a proximal side of the clot collection net and configured to direct the clot into the clot collection net as the deployment wire is drawn in the proximal direction.
  • the wire delivery tube is initially disposed inside a main delivery tube during delivery.
  • the method includes advancing the main delivery tube in a distal direction through the blood vessel, carrying the wire delivery tube past the clot region.
  • the main delivery tube carries a net delivery tube in addition to the wire delivery tube, the net delivery tube carrying at least a portion of the clot collection net.
  • the method includes pulling the clot collection net from the net delivery tube by drawing the deployment wire in a proximal direction.
  • one or more the hoop and funnel are deployed from the wire delivery tube before the clot collection net is drawn from the net delivery tube.
  • the method may also include retracting the main delivery tube to expose the wire delivery tube and net delivery tube before deployment of the clot capture mechanisms.
  • the net delivery tube carrying at least a portion of the clot collection net includes a secondary wire attached to the distal end of the net.
  • the wire allows for the distal end of the net to be directionally controlled, and potentially retracted into the net delivery tube if necessary.
  • the net delivery tube carrying at least a portion of the clot collection net includes a catheter with a "J" shaped tip known in the art as an angiographic catheter, attached to the distal end of the net.
  • the catheter allows for the distal end of the net to be directionally controlled, and potentially retracted into the net delivery tube if necessary.
  • the use of a catheter also allows for the infusion of clot busting drugs into the net surrounding the clot, thus dissolving clots that may be too large, or too hard for extraction.
  • the catheter could also be used to aspirate the portions of the clot that dissolve for easy removal.
  • the present invention provides a clot retriever.
  • the clot retriever includes a deployment wire having a distal end and a proximal end.
  • a resiliently collapsible hoop is integrally formed in the distal end of the deployment wire, and a clot collection net is coupled to the resiliently collapsible hoop.
  • a wire delivery tube is configured to translatably receive the deployment wire so that the resiliently collapsible hoop can be moved from a retracted position where the hoop is constrained within the lumen of the wire delivery tube to an advanced position where the hoop is deployed by releasing from constraint. Once released from constraint, the hoop is configured to deploy laterally outwardly from a main body of the wire to unfurl the clot collection net.
  • the deployment wire comprises a shape memory metal such as nitinol formed into the resiliently collapsible hoop and the main body.
  • the clot retriever includes a collapsible funnel.
  • the funnel is attached to the main body at a location proximal to the resiliently collapsible hoop.
  • the funnel when free from constraint and deployed, is tapered to have a clot receiving opening at its proximal end which is larger than a clot directing opening at its distal end.
  • the funnel has curved sides.
  • the curved sides are configured to interleave when the funnel is collapsed, pre-deployment, in the wire delivery tube. When deployed, the funnel can expand or unfold to a preselected dimension, or to the extent of the lumen of the blood vessel.
  • the clot retriever includes a main delivery tube.
  • the main delivery tube has a lumen configured to translatably receive the wire delivery tube.
  • the clot collection net everts from a distal end of the wire delivery tube.
  • the clot collection net and wire delivery tube are stowed in parallel within the main delivery tube prior to deployment.
  • a net delivery tube has a lumen and a distal opening which receives the clot collection net. The net delivery tube is stowed in parallel to the wire delivery tube within the main delivery tube.
  • the net is made from a mesh like material such as Nylon or polyester with mesh porosity sufficient for capture and retainment of clot material.
  • the net is made from a compliant plastic material such as polyurethane with a pattern of holes cut or punched in it sufficient for capture and retainment of clot material.
  • the clot capture net is shaped such that is can enclose and retain the clot, such shape to be cylindrical, conical, or a combination thereof.
  • the deployment wire has a length in the range from 10 cm to 250 cm.
  • the clot collection net is a short net having a length with a length in the range from 0.1 cm to 20 cm.
  • the net is a long net having a length in the range from 0.1 cm to 20 cm.
  • the funnel is a short funnel having a length in the range from 0.1 cm to 20 cm.
  • the funnel comprises a long funnel having a length in the range from 0.1 cm to 20 cm. It will be obvious to those of skill in the art that various configurations of the deployment wire, clot collection net, funnel, and other components may be assembled based on the parameters of the delivery catheter or tube and to suit the characteristics of the blood vessel and clot to be removed.
  • FIG. 1 illustrates a first clot retrieval device 100, pre-deployment, according to an example embodiment.
  • FIG. 2 illustrates the first clot retrieval device 100, mid-deployment, according to an example embodiment.
  • FIG. 3 also illustrates the first clot retrieval device 100, mid-deployment, according to an example embodiment.
  • FIG. 4 illustrates the first clot retrieval device 100, post-deployment, according to an example embodiment.
  • FIG. 5 illustrates the first clot retrieval device 100 entraining a clot 190 in a blood vessel 180, according to an example embodiment.
  • FIG. 6 illustrates the first clot retrieval device 100 capturing the clot 190 in the blood vessel 180, according to an example embodiment.
  • FIG. 7 illustrates the first clot retrieval device 100 retrieving the clot 190 in the blood vessel 180, according to an example embodiment.
  • FIG. 8 illustrates the first clot retrieval device 100 capturing a clot 190 in a left pulmonary artery 850, according to an example embodiment.
  • FIG. 9 illustrates a second clot retrieval device 200, pre-deployment, according to an example embodiment.
  • FIG. 10 illustrates a second clot retrieval device 200, post-deployment, according to an example embodiment.
  • FIG. 11 illustrates a third clot retrieval device 300, post-deployment, according to an example embodiment.
  • FIGs. 1-4 illustrate a first clot retrieval device 100 throughout various stages of deployment.
  • Clot retrieval device 100 comprises a deployment wire 130 with a resiliently collapsible hoop 125 formed integrally in a distal end.
  • a clot collection net 145 is coupled to the collapsible hoop 125.
  • a collapsible funnel 165 is also at a distal end of the deployment wire 130 but proximal from the hoop 125.
  • the funnel 165 has curved sides configured to interleave while the funnel is collapsed inside the wire delivery tube.
  • the hoop 125 is initially collapsed and disposed within the wire delivery tube 120.
  • the deployment wire 130 is also translatably received by the wire delivery tube 120.
  • the clot collection net 145 is initially disposed at least partially in within a net delivery tube 140.
  • the funnel 165 is also collapsed within the wire delivery tube 120.
  • Both the wire delivery tube 120 and net delivery tube 140 are disposed within a main delivery tube 110.
  • the main delivery tube is retracted to expose the wire delivery tube and net delivery tube 140.
  • the wire delivery tube is itself retracted (or the deployment wire 130 otherwise advanced in a distal direction through the wire delivery tube 120) allowing the resiliently collapsible hoop 125 to emerge from the distal end of the wire delivery tube 120.
  • the hoop 125 expands laterally relative to a longitudinal axis of the deployment wire 130.
  • the funnel 165 may also emerge from the wire delivery tube.
  • the funnel After deployment of the clot retrieval device 100, as shown in FIG. 4, the funnel has expanded to a stable configuration for entraining and directing occlusive material to the clot collection net 145.
  • a proximal opening of the funnel can be larger than a distal opening of the funnel to more effectively guide clot material into the clot collection net 145.
  • the distal opening of the funnel can be smaller than the opening of the deployed hoop 125.
  • FIGs. 5-7 illustrate removal of a clot 190 in a blood vessel 180 with the clot retrieval device.
  • the main delivery tube is advanced past a clot region.
  • the hoop 125 and funnel of the clot retrieval device are then deployed and the deployment wire is retracted to advance the funnel 165 and hoop 125 in a proximal direction of the blood vessel back towards the clot region.
  • a first portion of the clot 190 is entrained by the funnel as the deployment wire is retracted in a proximal direction.
  • the funnel guides the clot into the resiliently collapsible net 145 as shown in FIG. 6.
  • the deployment wire continues to retract, the clot passes through the funnel and into the net 145.
  • the deployment wire is further retracted until the net 145 and clot are pulled out of the blood vessel.
  • the net 145 may completely emerge from the net delivery tube 140, as shown in FIG. 7.
  • the net delivery tube 140 may then be retracted before the clot is engaged by the funnel 165 and/or hoop 125.
  • wire or tube 146 distally attached to the clot collection net such that the net can be positioned therefrom, or retrieved into the net delivery tube.
  • the addition of the wire or tube provides the user the option of retracting the net into the delivery tube, or of infusing drugs into the net space, which could include clot busting drugs to soften hard clots.
  • FIGs. 9-10 illustrates a second clot retrieval device 200 before and after deployment.
  • the second clot retrieval device comprises a deployment wire 230 with a resiliently collapsible hoop 225 formed integrally in a distal end.
  • a clot collection net 245 is coupled to the collapsible hoop 225.
  • the funnel 265 has curved sides configured to interleave while the funnel is collapsed inside the wire delivery tube.
  • the second clot retrieval device has only a single catheter or tube for carrying the capture mechanisms.
  • the net 245, hoop 225, and funnel 265 each emerge from the deployment tube as the deployment wire 230 is retracted in a proximal direction.
  • the second clot retrieval device 200 entrains and retrieves a clot in a similar manner as the first clot retrieval device 100.
  • FIG. 11 illustrates a third clot retrieval device 300.
  • the clot retrieval device comprises a resiliently collapsible hoop 325 coupled to a clot collection net 345 which are both disposed in a single tube until deployment.
  • the hoop 325 and net 345 are deployed by advancing a deployment wire 330 in a distal direction.
  • the third clot retrieval device 300 omits a funnel for guiding a clot 390 into the clot collection net 345, the clot may still be entrained and retrieved by the clot collection net when the deployment wire is retracted in a proximal direction after deployment.
  • the method comprises advancing a wire delivery tube in a distal direction through a blood vessel and past or through a clot region.
  • a deployment wire is then advanced in a distal direction from a distal end of the wire delivery tube to deploy the collapsible hoop on the distal side of the clot region.
  • the deployment wire is then drawn in a proximal direction to pass the deployed hoop over and past the region to direct the clot into the clot collection net.
  • the clot is directed into the net by the funnel.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne des procédés et des dispositifs qui sont conçus pour l'élimination par cathéter de tissu indésirable ou de matière occlusive depuis des vaisseaux sanguins et d'autres lumières corporelles, et qui reposent sur un fil avancé à partir d'un tube pour déployer un filet de capture qui peut être tiré sur le caillot. L'appareil comprend des mécanismes simples et fiables pour le déploiement de filets, d'entonnoirs et d'autres mécanismes de capture de caillot pour extraire un matériau de caillot depuis l'intérieur d'un vaisseau sanguin.
PCT/US2017/066789 2016-12-20 2017-12-15 Récupérateurs de caillot et procédés de déploiement WO2018118706A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US16/410,912 US11737769B2 (en) 2016-12-20 2019-05-13 Clot retrievers and methods for deployment

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662436920P 2016-12-20 2016-12-20
US62/436,920 2016-12-20

Related Child Applications (1)

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US16/410,912 Continuation-In-Part US11737769B2 (en) 2016-12-20 2019-05-13 Clot retrievers and methods for deployment

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WO2018118706A1 true WO2018118706A1 (fr) 2018-06-28

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020122978A1 (fr) 2018-12-15 2020-06-18 Guerra Eric Raul Cathéter de thrombectomie et procédés d'utilisation
US11172946B2 (en) 2018-10-26 2021-11-16 Progressive NEURO, Inc. Apparatus, system, and method for vasculature obstruction removal
US11197685B2 (en) 2018-11-15 2021-12-14 Progressive NEURO, Inc. Apparatus, system, and method for vasculature obstruction removal
US11253279B2 (en) 2018-11-15 2022-02-22 Progressive NEURO, Inc. Apparatus, system, and method for vasculature obstruction removal
US11737769B2 (en) 2016-12-20 2023-08-29 Omar M. Lattouf Clot retrievers and methods for deployment
US11857211B2 (en) 2019-01-08 2024-01-02 Progressive NEURO, Inc. Apparatus, system, and method for vasculature obstruction removal

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Publication number Priority date Publication date Assignee Title
US20030100919A1 (en) * 1999-07-30 2003-05-29 Incept Llc Vascular device for emboli, thrombus and foreign body removal and methods of use
US20030176884A1 (en) * 2002-03-12 2003-09-18 Marwane Berrada Everted filter device
US20040153119A1 (en) * 2003-01-30 2004-08-05 Kusleika Richard S. Embolic filters with a distal loop or no loop
US20050055047A1 (en) * 2003-09-04 2005-03-10 Secant Medical, Llc Endovascular snare for capture and removal of arterial emboli
US20090240238A1 (en) * 2008-03-24 2009-09-24 Medtronic Vascular, Inc. Clot Retrieval Mechanism
US20110125181A1 (en) * 2008-07-22 2011-05-26 Eamon Brady Clot capture systems and associated methods
WO2011110356A1 (fr) * 2010-03-10 2011-09-15 Acandis Gmbh & Co. Kg Dispositif médical pour extraire des concrétions présentes dans des organes corporels creux et procédé pour produire un tel dispositif
US20110230909A1 (en) * 2005-04-01 2011-09-22 Nexgen Medical Systems, Inc. Thrombus removal system and process
US20130197567A1 (en) * 2010-10-22 2013-08-01 Neuravi Limited Clot engagement and removal system
US20140276922A1 (en) * 2013-03-15 2014-09-18 Cook Medical Technologies Llc Shape memory metal emboli trap

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030100919A1 (en) * 1999-07-30 2003-05-29 Incept Llc Vascular device for emboli, thrombus and foreign body removal and methods of use
US20030176884A1 (en) * 2002-03-12 2003-09-18 Marwane Berrada Everted filter device
US20040153119A1 (en) * 2003-01-30 2004-08-05 Kusleika Richard S. Embolic filters with a distal loop or no loop
US20050055047A1 (en) * 2003-09-04 2005-03-10 Secant Medical, Llc Endovascular snare for capture and removal of arterial emboli
US20110230909A1 (en) * 2005-04-01 2011-09-22 Nexgen Medical Systems, Inc. Thrombus removal system and process
US20090240238A1 (en) * 2008-03-24 2009-09-24 Medtronic Vascular, Inc. Clot Retrieval Mechanism
US20110125181A1 (en) * 2008-07-22 2011-05-26 Eamon Brady Clot capture systems and associated methods
WO2011110356A1 (fr) * 2010-03-10 2011-09-15 Acandis Gmbh & Co. Kg Dispositif médical pour extraire des concrétions présentes dans des organes corporels creux et procédé pour produire un tel dispositif
US20130197567A1 (en) * 2010-10-22 2013-08-01 Neuravi Limited Clot engagement and removal system
US20140276922A1 (en) * 2013-03-15 2014-09-18 Cook Medical Technologies Llc Shape memory metal emboli trap

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11737769B2 (en) 2016-12-20 2023-08-29 Omar M. Lattouf Clot retrievers and methods for deployment
US11172946B2 (en) 2018-10-26 2021-11-16 Progressive NEURO, Inc. Apparatus, system, and method for vasculature obstruction removal
US11197685B2 (en) 2018-11-15 2021-12-14 Progressive NEURO, Inc. Apparatus, system, and method for vasculature obstruction removal
US11253279B2 (en) 2018-11-15 2022-02-22 Progressive NEURO, Inc. Apparatus, system, and method for vasculature obstruction removal
US11723678B2 (en) 2018-11-15 2023-08-15 Progressive NEURO, Inc. Apparatus, system, and method for vasculature obstruction removal
WO2020122978A1 (fr) 2018-12-15 2020-06-18 Guerra Eric Raul Cathéter de thrombectomie et procédés d'utilisation
EP3893981A4 (fr) * 2018-12-15 2022-08-10 Guerra, Eric Raul Cathéter de thrombectomie et procédés d'utilisation
US11857211B2 (en) 2019-01-08 2024-01-02 Progressive NEURO, Inc. Apparatus, system, and method for vasculature obstruction removal

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