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WO2008124567A1 - Extracteur de thrombus vasculaire et procédé d'extraction - Google Patents

Extracteur de thrombus vasculaire et procédé d'extraction Download PDF

Info

Publication number
WO2008124567A1
WO2008124567A1 PCT/US2008/059366 US2008059366W WO2008124567A1 WO 2008124567 A1 WO2008124567 A1 WO 2008124567A1 US 2008059366 W US2008059366 W US 2008059366W WO 2008124567 A1 WO2008124567 A1 WO 2008124567A1
Authority
WO
WIPO (PCT)
Prior art keywords
basket
distal end
guiding catheter
thrombus
blood vessel
Prior art date
Application number
PCT/US2008/059366
Other languages
English (en)
Inventor
Alex Powell
Original Assignee
Edwards Lifesciences Corporation
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 Edwards Lifesciences Corporation filed Critical Edwards Lifesciences Corporation
Publication of WO2008124567A1 publication Critical patent/WO2008124567A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/30—Surgical pincettes, i.e. surgical tweezers without pivotal connections
    • A61B2017/306—Surgical pincettes, i.e. surgical tweezers without pivotal connections holding by means of suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • the field of the present invention is mechanical means and methods for the extraction of stationary vascular obstructive material.
  • Techniques and instruments have been developed for use in the removal or repair of obstructive material in vessels and other body passageways. Such material includes thrombus forming into clots, either at a point of blockage or through migration to the point of obstruction as an embolus.
  • Patents which discuss devices and methods for removal of emboli include United States Patent No. 5,800,457 to Gelbfish, which issued on Sep. 1 , 1998 and is entitled "Intravascular Filter and Associated Methodology"; United States Patent No. 5,836,968 to Simon et al., which issued on Nov.
  • Fogarty embolectomy balloons and catheters have been shown to remove large amounts of thrombus and whole clots. However, such balloons and catheters require surgical exposure to remove clots from vessels.
  • the technique of guiding catheter thrombectomy employs an end hole catheter or guide which is advanced to the thrombus with vigorous suction applied. This technique is frequently successful in placing the clot in attachment to the catheter/guide. However, the clot frequently is detached when the catheter/guide is retracted into the sheath. This is understood to occur because the clot is frequently larger than the sheath and the clot is sheared off upon withdrawal of the catheter/guide into the sheath.
  • the present invention is directed to both method and apparatus for the removal of whole clots without fragmentation and, where necessary, substantial thrombus with easy reentry to complete clot removal.
  • a basket is inserted into a blood vessel from which a vascular clot is to be removed.
  • the basket is collapsible upon acquisition of the whole clot or available thrombus for axial removal and, if necessary, facile reentry.
  • the method includes inserting a basket into a blood vessel from which a clot is to be excised.
  • the basket is collapsed to compress acquired thrombus, which may or may not be the entire clot.
  • the method includes inserting a collapsed basket into a blood vessel from which a clot is to be excised.
  • the basket is then expanded and acquires thrombus and possibly a whole clot.
  • the basket is then collapsed to compress acquired thrombus and withdrawn from the vessel axially through a guiding catheter.
  • the expansion of the basket may be accomplished by extending the basket from the distal end of a catheter when adjacent the clot.
  • the basket may be collapsed to compress acquired thrombus by drawing the basket back into the distal end of the catheter.
  • the method includes inserting a basket in a guiding catheter into a blood vessel from which a clot is to be excised.
  • the basket is extended to acquire thrombus and then retracted into the guiding catheter.
  • the retraction into the guiding catheter compresses the basket and the thrombus therein.
  • the basket can then be drawn through the guiding catheter for full extraction from the catheter.
  • the procedure may then be undertaken again to acquire and remove remaining thrombus without having to reinsert the guiding catheter if the whole clot was not extracted in the first removal.
  • an extractor includes a guiding catheter.
  • a basket is fixed to and extends from a distal end of a long element and extends longitudinally of a guide lumen.
  • the basket and element are able to move longitudinally through the guide lumen of a guiding catheter.
  • the basket When the basket is unconstrained, it defines a cavity which is of increasing cross section that is greater than the lumen of the guiding catheter.
  • the basket is able to fit within the lumen when constrained by the guiding catheter.
  • a basket is provided on the end of a long element and extend longitudinally of the guide lumen to move longitudinally through the guiding catheter.
  • the basket includes rods which extend from the distal end of the long element to cooperate with flexible sheet material between the rods.
  • the resulting basket can be constructed to be fully expanded when in the unconstrained state.
  • the acquisition of thrombus, either partial or whole clots, in any of the foregoing separate aspects may be by the application of suction through the center of the basket.
  • any of the foregoing aspects are contemplated to be combined to greater advantage. [0016] Accordingly, it is an object of the present invention to provide an improved method and apparatus for the mechanical extraction of vascular thrombus and whole clots. Other and further objects and advantages will appear hereinafter.
  • Figure 1 is a side view of a cannula with a basket on the distal end thereof positioned in a guiding catheter. The view is partially broken away for clarity.
  • Figure 2 is a side view of the device depicted in Figure 1 with the basket partially retracted into the guiding catheter.
  • FIG. 3 is a side view of a device according to an embodiment of the invention.
  • the extractor includes a guiding catheter 10 of conventional construction.
  • the guiding catheter may be plain or may include other features such as multiple longitudinal lumens and balloons.
  • a balloon 12 is provided at the distal end of the guiding catheter 10 in the present embodiment.
  • a catheter with a balloon, and additional features not relevant here, is disclosed in U.S. Patent Application Publication No. 2004/0138614, the disclosure of which is incorporated herein by reference.
  • the guiding catheter 10 has a guide lumen 14 extending fully through the catheter 10.
  • a long element in the form of a cannula 16 extends longitudinally through the guide lumen 14 to the distal end 18 of the catheter 10.
  • the cannula 16 includes a flow lumen 20 therethrough.
  • the cannula 16 is coaxially arranged with the guiding catheter 10 in the illustrated embodiment and can move longitudinally therein.
  • a resilient basket 22 is fixed at the distal end 24 of the cannula
  • the resilient basket 22 is defined by flexible sheet material 26 shown to be formed in a truncated conical shape.
  • the material 26 may be either porous or nonporous depending upon the specific utility of the device.
  • the sheet material 26 is flexible so that it may be retained in a radially compressed configuration within the guiding catheter 10.
  • the sheet material 26 may also exhibit resilience to fully expand the basket 22 when unconstrained.
  • Rods 28 are affixed to the material 26 to add structural integrity to the basket 22.
  • the rods 28 are designed to pivot in a radial direction from a position substantially parallel to one another when collapsed within the guiding catheter 10 to the fully unconstrained truncated conical shape when extending outwardly of the guiding catheter 10.
  • rods 28 There may be any number of rods 28 but four to six are considered practical.
  • the rods 28 may be attached to either side of the sheet material 26. Because of the interaction with the guide catheter 10, the rods 28 may best be placed on the outside of the sheet material 26 to ride on the distal end of the lumen 14 and to push the sheet material 26 from behind when compressing thrombus.
  • the truncated conical shape provides for the cavity defined within the resilient basket 22 to have an increasing cross section which is greater than the cross section of the guide lumen 14 away from the distal end of the guiding catheter.
  • Other than a strictly conical shape may be employed as may be convenient such as when greater depth and cavity volume is desired with the outer periphery constrained to a practical maximum diameter.
  • the rods 28 are configured to be sufficiently rigid that vascular thrombus contained within the cavity of the basket will be compressed as the rods are forced inwardly by the guiding cannula.
  • the rods 28 may be straight or curved with the concavity facing inwardly of the basket 22 to increase cavity volume.
  • the hinging of the rods 28 may be by mechanical hinges, living hinges or simply adherence to the flexible sheet material 26 which in turn provides the hinging action.
  • the hinging of the rods 28 may contribute to the bias acting to expand the basket 22 to its fully open state when unconstrained.
  • the sheet material 26 may preferably be bonded to the end of the cannula 16, integrally fabricated into the cannula 16, or even clamped or sewn in place.
  • the guiding catheter 10 is appropriately inserted into the targeted blood vessel 32 using conventional techniques such that the distal end 18 of the guiding catheter 10 comes into position adjacent the targeted vascular clot. Naturally, the proportions of the extractor and the components thereof are selected to meet the specific requirements of the targeted vessel and vascular clot. [0028] Once appropriately inserted, the extractor is manipulated to move the cannula 16 longitudinally to extend the basket 22 which is extending longitudinally of the guide lumen from the end of the guiding catheter 10. In this way, the basket 22 is expanded from a radially collapsed state to an unconstrained fully expanded state to the extent allowed by the vessel 32 adjacent to the clot.
  • the foil expansion may be by the resilience of the material 26, the configuration of the rods 28 or additional spring elements associated with the rods 28.
  • the basket 22 is expanded until it is adjacent to and/or contacts the walls of the blood vessel 32.
  • the entire clot or portion thereof, either being made up of thrombus, is then acquired in the cavity of the basket 22. This acquisition may be through the axial movement of the basket 22.
  • the port 30 defined by the flow lumen 20 of the cannula 16 which opens into the cavity of the basket 22 may be subjected to suction through the flow lumen 20. Such suction can draw vascular thrombus, typically the clot as one mass, into the cavity of the basket 22 for acquisition.
  • the basket 22 and the acquired thrombus therein are radially compressed. This compression continues until the basket 22 is withdrawn substantially fully into the guide lumen 14 of the guiding catheter 10. The withdrawal of the basket 22 may continue such that the longitudinally arranged and movable cannula 16 and basket 22 are drawn fully from the guiding catheter 10. A fresh cannula 16 can then be inserted for measurement or further thrombus extraction without withdrawing the guiding catheter 10.
  • the balloon 12 can be inflated until it is adjacent and/or contacts the walls of the blood vessel 32 to thereby prevent flow.
  • the balloon 12 may also be used when suction through the cannula 16 is employed. This prevents flow around the basket 22 which might distort the basket 22 and/or frustrate efforts to reduce pressure in the blood vessel 32 and draw flow from the direction of the clot. With the guiding catheter retained in position within the vessel 32, the balloon 12 can prevent flow while multiple attempts to clear the entire targeted clot are made using multiple cannula 16.
  • a device 40 according to an embodiment of the present invention comprises an elongate flexible guiding catheter body 42 having a proximal end 44 and a distal end 46. At the distal end 46 of the guiding catheter body 42 is a distal material removal tip 48, such as depicted in FIGS. 1 and 2.
  • a control 50 (which in the particular embodiment depicted is configured as a hand-held control) is attached to the proximal end 44 of the guiding catheter body 42 and permits manipulation of the system 40, which may include (by way of example) extension and retraction of the basket and rods (depicted as elements 22 and 28 in FIGS. 1 and 2, but not visible in the larger view of FIG.
  • a vacuum source 52 may be secured to and communicating with the hand-held control 50, which may in turn include connecting passages through which the vacuum source 52 can create a negative pressure in the interior of the guiding catheter body 42 and/or interior of an elongate member (such as the cannula 16 depicted in Figures 1 and 2) passing within the interior of the guiding catheter body 42.
  • the negative pressure thus created by the vacuum source 52 can provide suction at the distal end 46, such as at the port 30 through the flow lumen 20 of Figures 1 and 2.
  • a drive motor (not shown) may be mounted within the hand-held control 50 for supplying longitudinal, rotational, or other motion to an elongated element (such as the cannula 16 from Figures 1 and 2) extending through the guiding catheter body 42.
  • an elongated element such as the cannula 16 from Figures 1 and 2
  • the cannula 16 or other elongate member may be hollow, thus permitting passage therethrough of a guidewire 54 which can extend through the distal material removal tip 48 as depicted in Figure 3.

Landscapes

  • 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

L'invention concerne un extracteur pour le thrombus vasculaire qui inclut un cathéter de guidage avec une canule axialement mobile à l'intérieur. La canule inclut un panier élastique fixé au niveau de l'extrémité distale de celle-ci. Le panier définit une cavité qui est de section transversale croissante supérieure à la section transversale du cathéter de guidage loin de l'extrémité distale du cathéter lorsque le panier ne subit aucune contrainte. Le panier peut s'ajuster à l'intérieur du cathéter de guidage avant le déploiement et la subséquente extraction du thrombus vasculaire. Le panier inclut des tiges et un matériau en feuille souple afin de définir une cavité conique tronquée radialement compressible. Un ballonnet gonflable est associé à l'extrémité distale du cathéter de guidage. Un orifice à l'intérieur du panier permet l'application de succion à travers la canule pour aider dans l'extraction du thrombus vasculaire.
PCT/US2008/059366 2007-04-05 2008-04-04 Extracteur de thrombus vasculaire et procédé d'extraction WO2008124567A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US91044607P 2007-04-05 2007-04-05
US60/910,446 2007-04-05

Publications (1)

Publication Number Publication Date
WO2008124567A1 true WO2008124567A1 (fr) 2008-10-16

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Family Applications (1)

Application Number Title Priority Date Filing Date
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Country Status (1)

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9498604B2 (en) 1997-11-12 2016-11-22 Genesis Technologies Llc Medical device and method
US9561094B2 (en) 2010-07-23 2017-02-07 Nfinium Vascular Technologies, Llc Devices and methods for treating venous diseases
US11013523B2 (en) 2015-01-13 2021-05-25 Anaconda Biomed, S.L. Thrombectomy device, system and method for extraction of vascular thrombi from a blood vessel
US11266414B2 (en) 2014-06-04 2022-03-08 Vascular Development Corp, Llc Low radial force vascular device and method of occlusion
US11534191B2 (en) 2019-01-11 2022-12-27 Anaconda Biomed, S.L. Loading device for loading a medical device into a catheter
US11771446B2 (en) 2020-10-19 2023-10-03 Anaconda Biomed, S.L. Thrombectomy system and method of use
US11986195B2 (en) 2018-10-16 2024-05-21 Anaconda Biomed, S.L. Device and a thrombectomy apparatus for extraction of thrombus from a blood vessel
US12102529B2 (en) 2015-04-30 2024-10-01 Emstop Inc. Valve replacement devices and methods
US12440650B2 (en) 2023-02-27 2025-10-14 Vascular Development Corp, Llc Augmented delivery catheter and method

Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4873978A (en) * 1987-12-04 1989-10-17 Robert Ginsburg Device and method for emboli retrieval
US5011488A (en) * 1988-12-07 1991-04-30 Robert Ginsburg Thrombus extraction system
US5102415A (en) * 1989-09-06 1992-04-07 Guenther Rolf W Apparatus for removing blood clots from arteries and veins
US5417697A (en) * 1993-07-07 1995-05-23 Wilk; Peter J. Polyp retrieval assembly with cauterization loop and suction web
WO1996019941A1 (fr) * 1994-12-23 1996-07-04 New York Society For The Ruptured And Crippled Maintaining The Hospital For Special Surgery Filtre pour veine cave
US5800457A (en) 1997-03-05 1998-09-01 Gelbfish; Gary A. Intravascular filter and associated methodology
US5836968A (en) 1996-07-17 1998-11-17 Nitinol Medical Technologies, Inc. Removable embolus blood clot filter
US6231533B1 (en) 1999-05-21 2001-05-15 Ppg Industries Ohio, Inc. Orthopedic splinting article
US6312407B1 (en) 1995-06-05 2001-11-06 Medtronic Percusurge, Inc. Occlusion of a vessel
US6702782B2 (en) 2001-06-26 2004-03-09 Concentric Medical, Inc. Large lumen balloon catheter
US20040138614A1 (en) * 1998-08-07 2004-07-15 Edwards Lifesciences Corp. Inflatable cannula
US6790215B2 (en) 1999-04-30 2004-09-14 Edwards Lifesciences Corporation Method of use for percutaneous material removal device and tip
WO2006031410A2 (fr) * 2004-09-10 2006-03-23 Penumbra, Inc. Systeme et procede pour traiter un accident ischemique cerebral

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4873978A (en) * 1987-12-04 1989-10-17 Robert Ginsburg Device and method for emboli retrieval
US5011488A (en) * 1988-12-07 1991-04-30 Robert Ginsburg Thrombus extraction system
US5102415A (en) * 1989-09-06 1992-04-07 Guenther Rolf W Apparatus for removing blood clots from arteries and veins
US5417697A (en) * 1993-07-07 1995-05-23 Wilk; Peter J. Polyp retrieval assembly with cauterization loop and suction web
WO1996019941A1 (fr) * 1994-12-23 1996-07-04 New York Society For The Ruptured And Crippled Maintaining The Hospital For Special Surgery Filtre pour veine cave
US6312407B1 (en) 1995-06-05 2001-11-06 Medtronic Percusurge, Inc. Occlusion of a vessel
US5836968A (en) 1996-07-17 1998-11-17 Nitinol Medical Technologies, Inc. Removable embolus blood clot filter
US5800457A (en) 1997-03-05 1998-09-01 Gelbfish; Gary A. Intravascular filter and associated methodology
US20040138614A1 (en) * 1998-08-07 2004-07-15 Edwards Lifesciences Corp. Inflatable cannula
US6790215B2 (en) 1999-04-30 2004-09-14 Edwards Lifesciences Corporation Method of use for percutaneous material removal device and tip
US6231533B1 (en) 1999-05-21 2001-05-15 Ppg Industries Ohio, Inc. Orthopedic splinting article
US6702782B2 (en) 2001-06-26 2004-03-09 Concentric Medical, Inc. Large lumen balloon catheter
WO2006031410A2 (fr) * 2004-09-10 2006-03-23 Penumbra, Inc. Systeme et procede pour traiter un accident ischemique cerebral

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9498604B2 (en) 1997-11-12 2016-11-22 Genesis Technologies Llc Medical device and method
US9561094B2 (en) 2010-07-23 2017-02-07 Nfinium Vascular Technologies, Llc Devices and methods for treating venous diseases
US12357314B2 (en) 2014-06-04 2025-07-15 Vascular Development Corp, Llc Low radial force vascular device and method of occlusion
US11266414B2 (en) 2014-06-04 2022-03-08 Vascular Development Corp, Llc Low radial force vascular device and method of occlusion
US12161352B2 (en) 2015-01-13 2024-12-10 Anaconda Biomed, S.L. Thrombectomy device, system and method for extraction of vascular thrombi from a blood vessel
US11013523B2 (en) 2015-01-13 2021-05-25 Anaconda Biomed, S.L. Thrombectomy device, system and method for extraction of vascular thrombi from a blood vessel
US12102529B2 (en) 2015-04-30 2024-10-01 Emstop Inc. Valve replacement devices and methods
EP3288492B1 (fr) * 2015-04-30 2024-10-16 EmStop Inc. Système d'implantation d'une prothèse valve aortique et d'un cathéter de blocage de matériel embolique
US11986195B2 (en) 2018-10-16 2024-05-21 Anaconda Biomed, S.L. Device and a thrombectomy apparatus for extraction of thrombus from a blood vessel
US11534191B2 (en) 2019-01-11 2022-12-27 Anaconda Biomed, S.L. Loading device for loading a medical device into a catheter
US11771446B2 (en) 2020-10-19 2023-10-03 Anaconda Biomed, S.L. Thrombectomy system and method of use
US12364492B2 (en) 2020-10-19 2025-07-22 Anaconda Biomed, S.L. Thrombectomy system and method of use
US12440650B2 (en) 2023-02-27 2025-10-14 Vascular Development Corp, Llc Augmented delivery catheter and method

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