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WO2012167137A1 - Systèmes et méthodes de capture et de retrait de caillots de sang - Google Patents

Systèmes et méthodes de capture et de retrait de caillots de sang Download PDF

Info

Publication number
WO2012167137A1
WO2012167137A1 PCT/US2012/040536 US2012040536W WO2012167137A1 WO 2012167137 A1 WO2012167137 A1 WO 2012167137A1 US 2012040536 W US2012040536 W US 2012040536W WO 2012167137 A1 WO2012167137 A1 WO 2012167137A1
Authority
WO
WIPO (PCT)
Prior art keywords
arm
capture structure
fins
arrangement
clot
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2012/040536
Other languages
English (en)
Inventor
Brent Gerberding
Marc Jensen
Robert M. Abrams
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pulsar Vascular Inc
Original Assignee
Pulsar Vascular Inc
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 Pulsar Vascular Inc filed Critical Pulsar Vascular Inc
Publication of WO2012167137A1 publication Critical patent/WO2012167137A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • A61B17/22—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
    • 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 technology relates to systems and methods for removing blood clots in a blood vessel.
  • a blood clot can decrease or cut off blood flow through a blood vessel, and may result in damage or death to tissue supplied by that vessel. Further, if a blood clot dislodges and becomes free-floating, it can cause a stroke, heart attack, pulmonary embolism, or other negative condition. While early stage clots may be treatable with drugs, more advanced clots may have to be physically removed from the patient's vasculature using a treatment device.
  • Delivering a treatment device to a blood clot site can be difficult because of complex patient vasculature and/or particularities of the blood clot. For example, narrow and/or tortuous vasculature near the clot site can be very complicated to navigate. Additionally, several particularized treatment devices may be required for capturing variously sized and shaped blood clots.
  • Figure 1A is a partially schematic view of a clot removal device being endovascularly delivered proximate a blood clot in accordance with an embodiment of the technology.
  • Figures IB and 1C are partially schematic views of the clot removal device of Figure 1A in a deployed configuration proximate the blood clot in accordance with an embodiment of the technology.
  • the present disclosure describes therapeutic devices and associated methods for removing blood clots in a blood vessel.
  • the therapeutic devices and associated methods can be used to remove blood clots in the treatment of ischemic stroke.
  • selected embodiments of the present technology are directed to capture structures that are alternately configurable to engage with the blood clot in a low-profile configuration and in a deployed configuration.
  • the following description provides many specific details for a thorough understanding of, and enabling description for, embodiments of the disclosure.
  • Well-known structures, systems, and methods often associated with such systems have not been shown or described in detail to avoid unnecessarily obscuring the description of the various embodiments of the disclosure.
  • those of ordinary skill in the relevant art will understand that additional embodiments may be practiced without several of the details described below.
  • Figures 1A-1C are partially schematic views of a clot removal device 100 being delivered proximate to a blood clot C in a blood vessel V of a patient in accordance with an embodiment of the technology.
  • Figures 1A-1C illustrate the clot removal device 100 being deployed from a low-profile, collapsed delivery state (Figure 1A) to a deployed state in which the clot removal device 100 is in an expanded configuration ( Figure 1C).
  • the clot removal device 100 can include a capture structure 102, a supplemental stabilizer 103, and a junction or joint 104 between the capture structure 102 and the supplemental stabilizer 103.
  • the capture structure 102 is configured to transform between the low-profile delivery arrangement and the expanded or deployed arrangement and can be used to capture and remove the clot C obstructing or partially obstructing the blood vessel V.
  • the clot removal device 100 is carried by a delivery device including an elongated, flexible introducer sheath 120 and a positioning mechanism 130, such as one or more delivery wires.
  • the clot removal device 100 is generally radially compressed along its longitudinal axis and arranged in a substantially cylindrical, low-profile arrangement within the sheath 120.
  • a proximal portion of the supplemental stabilizer 103 is attached to a distal portion of the positioning mechanism 130.
  • the clot removal device 100 may be collapsed into the low-profile arrangement shown in Figure 1 A using a loading sheath (not shown) into which the clot removal device 100 is loaded to assume a smaller diameter delivery arrangement before being transferred to the delivery sheath 120.
  • the clot removal device 100 may be installed within the delivery sheath 120 using other techniques.
  • the positioning mechanism 130 can be a pusher system associated with the proximal or distal portions of the supplemental stabilizer 103 and/or the capture structure 102.
  • the positioning mechanism 130 can move within the delivery sheath 120 to translate the clot removal device 100 relative to the delivery sheath 120.
  • the clot removal device 100 may be deployed by actively driving the positioning mechanism 130 distally to push the clot removal device 100 out of the delivery sheath 120 and/or by actively withdrawing the delivery sheath 120 while maintaining the positioning mechanism 130 and clot removal device 100 at a desired location.
  • the clot removal device t 100 and/or the positioning mechanism 130 can incorporate detachment elements or detachment mechanisms (not shown) for releasing the clot removal device 100.
  • Detachment mechanisms known in the art including mechanical, electrical, hydraulic, thermal, and/or other such systems may be used.
  • the capture structure 102 can include a first arm 140 and a second arm 150 proximally offset from the first arm 140 when the clot removal device 100 is in the compressed arrangement.
  • the first arm 140 includes a plurality of fins 142 extending laterally in a winged shape.
  • the fins 142 are coupled to one another with central and peripheral shafts, identified individually as shafts 148a-d.
  • the fins 142 are spaced apart from one another by a distance of from about 0.5 to about 3.0 cm and, in a particular embodiment, from about 0.5 to about 2.0 cm. In other embodiments, however, the fins 142 may have a different arrangement relative to each other and/or different dimensions.
  • the second arm 150 can likewise include a plurality of fins 152 extending in a chevron shape.
  • the fins 152 are coupled to one another with a central shaft and peripheral shafts 158a-c.
  • the fins 152 are spaced apart from one another by a distance of from about 0.5 to about 3.0 cm and, in a particular embodiment, from about 0.5 to about 2.0 cm. In other embodiments, however, the fins 152 may have a different arrangement relative to each other.
  • the capture structure 102 can also include pointed or protruding peripheral points 156a-e.
  • the clot removal device 100 can include multiple capture structures 102, laterally or proximally positioned relative to each other.
  • the clot removal device 100 and delivery device can be passed through the patient's vasculature using a guide catheter (not shown) or other known techniques while the clot removal device 100 is in the low-profile delivery arrangement illustrated in Figure 1A.
  • the arms 140 and 150 can be proximally offset (e.g., not interweaved), with one arm 140 ahead of the other 150.
  • the arms 140, 150 can be overlapped or interlaced in the low-profile arrangement.
  • the positioning mechanism 130 is moved distally and/or the delivery sheath 120 is moved proximally until the capture structure 102 is positioned beyond the distal end of the delivery sheath 120 ( Figures IB and 1C).
  • one or more of the protruding peripheral points 156a-e can engage with the clot C prior to or during deployment of the capture structure 102.
  • the distal-most peripheral point 156a can pierce or pass through the clot C before the clot removal device 100 is fully deployed.
  • connections of the arms 140, 150 to a central shaft and peripheral shafts 158a-c can provide grabbing action by advancing or retracting the delivery sheath 120 relative to the device 100.
  • the grabbing action can also be performed by advancing and/or retracting the guide catheter (not shown).
  • the capture structure 102 expands into the deployed arrangement in which the fins 142 of the first arm 140 are interleaved with the fins 152 of the second arm 150 such that the fins 142, 152 engage one another when pulled at a proximal end.
  • the protruding peripheral points 156a-e can further engage with (e.g., pierce) the clot C.
  • the arms 140 and 150 can slide through, surround, or partially surround a portion of the clot C.
  • the number and spacing of the fins 142 and 152 in the capture structure 102 can be controlled to control the amount of engagement of the fins 142 and 152 with the clot C.
  • the fins 142 and 152 can together compress the clot C to engage it, and the capture structure 102 and the clot C can then be pulled from the blood vessel V to remove the clot C.
  • the clot removal device 100 can be deployed in the vessel V at a point beyond the clot C. Upon withdrawing the clot removal device 100, the clot C is also withdrawn from the vessel V.
  • the arms 140 and 150 can be staggered along the clot removal device 100 to reduce the profile of the device and better engage the clot C. In further embodiments, there can be a multiplicity of staggered arms to engage clots C of longer lengths.
  • the clot removal device 100 offers several advantages over conventional systems and techniques for clot removal.
  • the clot removal device 100 is transformable into the compressed or low-profile delivery arrangement illustrated in Figure 1A. This arrangement can allow the clot removal device 100 to more easily navigate within narrow and/or tortuous vasculature to a clot site. Navigation capability can be further improved by using flexible or somewhat flexible materials for all or a portion of the clot removal device 100.
  • the variable profile size of the clot removal device 100 (e.g., from the compressed, low-profile state to a fully deployed state— and positions in between) offers additional flexibility in effectively capturing and removing clots of varying sizes/shapes.
  • the clot removal device 100 can additionally improve the effectiveness of the clot removal process as compared with conventional devices.
  • the low profile arrangement of the clot removal device 100 can provide more push force to drive through and engage with clot(s) C.
  • the clot removal device 100 can include a plurality of capture structures 102 to more completely remove clot(s) C, and offers flexibility for varying clot sizes.
  • the clot removal device 100 having two capture structures 102 is expected to effectively capture a large clot C (e.g., the device 100 can engage with the clot C at multiple locations to improve the grasp of the clot C).
  • a more proximal capture structure can pierce through and be deployed beyond the clot C while a more distal capture structure can be deployed within the clot C.
  • a portion of the clot C can be removed with the distal capture structure, and the proximal capture structure can remove portions of the clot C not caught by the distal capture structure.
  • a clot removal device endovascularly deliverable to a treatment site comprising:
  • a capture structure transformable between a delivery arrangement and a deployed arrangement comprising—
  • first arm having a plurality of laterally-extending first arm fins, wherein the first arm fins, when deployed, are configured in a winged arrangement
  • second arm having a plurality of laterally-extending second arm fins configured to interleave with the first arm fins, wherein the second arm fins, when deployed are configured in a chevron arrangement
  • a plurality of protruding peripheral points configured to engage with the clot.
  • a third arm distally offset from the first arm and the second arm, the third arm, when deployed, having a plurality of laterally-extending third arm fins; and a fourth arm distally offset from the first arm and the second arm, the fourth arm, when deployed, having a plurality of laterally-extending fourth arm fins configured to interleave with the third arm fins.
  • the clot removal device of example 1 further comprising a positioning mechanism comprising a plurality of wires including a first wire and a second wire, wherein the first wire and the second wire are attached to different sites on the capture structure.
  • the clot removal device of example 3 further comprising a delivery sheath configured to at least partially surround the capture structure.
  • first and second wires are attached to the capture structure at a proximal portion of at least one of the first arm or the second arm, and wherein the first and second wires are configured to move proximally/distally relative to the delivery sheath.
  • the clot removal device of example 6 further comprising an introducer sheath configured to at least partially surround the capture structure when the capture structure is in the delivery arrangement.
  • a system for removing a blood clot comprising:
  • a capture structure configured for delivery proximate the blood clot via a blood vessel, wherein the capture structure is movable between a compressed arrangement and an expanded arrangement, the capture structure comprising— a first arm having a plurality of first arm lateral fins; and
  • a second arm having a plurality of second arm lateral fins configured to interleave with the first arm lateral fins
  • a delivery sheath configured to radially compress the capture structure when the capture structure is in the compressed arrangement
  • a positioning mechanism coupled to the capture structure and proximally moveable relative to the delivery sheath to alter the capture structure between the compressed arrangement and the expanded arrangement.
  • the first arm lateral fins are coupled to one another via a first central shaft and a first peripheral shaft;
  • the second arm lateral fins are coupled to one another via a second central shaft and a second peripheral shaft;
  • At least one of the first central shaft, first peripheral shaft, second central shaft, and second peripheral shaft comprises a protruding peripheral point configured to engage with the blood clot.
  • the positioning mechanism comprises a plurality of wires attached to the capture structure at a proximal portion of at least one of the first arm or the second arm, and wherein the plurality of wires are configured to move proximally/distally relative to the delivery sheath.
  • a method of removing a blood clot comprising:
  • the method of example 14 further comprising positioning the capture structure within vasculature of a human patient and proximate the blood clot using a plurality of wires including a first wire and a second wire, wherein the first wire and the second wire are attached to different sites on the capture structure.
  • engaging the blood clot with the capture structure comprises piercing the blood clot with a protruding peripheral point of the capture structure.
  • expanding the radially-compressed capture structure comprises expanding the capture structure at a treatment site within a patient vasculature distal to the blood clot.
  • expanding the radially-compressed capture structure comprises displacing the capture structure from a delivery sheath.
  • displacing the capture structure from the delivery sheath comprises at least one of (a) driving the capture structure in a distal direction, or (b) withdrawing the delivery sheath in a proximal direction.

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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)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne des systèmes et des méthodes de retrait de caillots de sang dans des vaisseaux sanguins. Dans certains modes de réalisation, les systèmes comprennent un dispositif de retrait de caillots pouvant être posé de manière endovasculaire au niveau d'un site de traitement. Le dispositif de retrait de caillots comprend une structure de capture comprenant un premier bras (140) ayant une pluralité d'ailettes de premier bras (142) s'étendant latéralement et un second bras (150) ayant une pluralité d'ailettes de second bras (152) s'étendant latéralement conçues pour s'imbriquer avec les ailettes de premier bras. Dans certains modes de réalisation, les ailettes de premier bras sont conçues selon un agencement à ailettes et les ailettes de second bras sont conçues selon un agencement en chevron. Le dispositif de retrait de caillots peut comprendre en outre une pluralité de points périphériques saillants (156) configurés pour venir en prise avec le caillot.
PCT/US2012/040536 2011-06-03 2012-06-01 Systèmes et méthodes de capture et de retrait de caillots de sang Ceased WO2012167137A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161493385P 2011-06-03 2011-06-03
US61/493,385 2011-06-03

Publications (1)

Publication Number Publication Date
WO2012167137A1 true WO2012167137A1 (fr) 2012-12-06

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Application Number Title Priority Date Filing Date
PCT/US2012/040536 Ceased WO2012167137A1 (fr) 2011-06-03 2012-06-01 Systèmes et méthodes de capture et de retrait de caillots de sang

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WO (1) WO2012167137A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9119625B2 (en) 2011-10-05 2015-09-01 Pulsar Vascular, Inc. Devices, systems and methods for enclosing an anatomical opening
US9259229B2 (en) 2012-05-10 2016-02-16 Pulsar Vascular, Inc. Systems and methods for enclosing an anatomical opening, including coil-tipped aneurysm devices
US9277924B2 (en) 2009-09-04 2016-03-08 Pulsar Vascular, Inc. Systems and methods for enclosing an anatomical opening
US10004510B2 (en) 2011-06-03 2018-06-26 Pulsar Vascular, Inc. Systems and methods for enclosing an anatomical opening, including shock absorbing aneurysm devices
US10624647B2 (en) 2011-06-03 2020-04-21 Pulsar Vascular, Inc. Aneurysm devices with additional anchoring mechanisms and associated systems and methods
CN111612860A (zh) * 2019-02-22 2020-09-01 未艾医疗技术(深圳)有限公司 基于VRDS 4D医学影像的栓塞的Ai识别方法及产品

Citations (5)

* 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
WO2003075793A1 (fr) * 2002-03-06 2003-09-18 Boston Scientific Limited Dispositif medical de retrait
US20060058837A1 (en) * 2004-09-10 2006-03-16 Arani Bose System and method for treating ischemic stroke
US20080269774A1 (en) * 2006-10-26 2008-10-30 Chestnut Medical Technologies, Inc. Intracorporeal Grasping Device
US20090306678A1 (en) * 2008-06-04 2009-12-10 Cook Incorporated Device for retrieving a foreign object located in a body vessel

Patent Citations (5)

* 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
WO2003075793A1 (fr) * 2002-03-06 2003-09-18 Boston Scientific Limited Dispositif medical de retrait
US20060058837A1 (en) * 2004-09-10 2006-03-16 Arani Bose System and method for treating ischemic stroke
US20080269774A1 (en) * 2006-10-26 2008-10-30 Chestnut Medical Technologies, Inc. Intracorporeal Grasping Device
US20090306678A1 (en) * 2008-06-04 2009-12-10 Cook Incorporated Device for retrieving a foreign object located in a body vessel

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11633189B2 (en) 2009-09-04 2023-04-25 Pulsar Vascular, Inc. Systems and methods for enclosing an anatomical opening
US9277924B2 (en) 2009-09-04 2016-03-08 Pulsar Vascular, Inc. Systems and methods for enclosing an anatomical opening
US10335153B2 (en) 2009-09-04 2019-07-02 Pulsar Vascular, Inc. Systems and methods for enclosing an anatomical opening
US10624647B2 (en) 2011-06-03 2020-04-21 Pulsar Vascular, Inc. Aneurysm devices with additional anchoring mechanisms and associated systems and methods
US11344311B2 (en) 2011-06-03 2022-05-31 Pulsar Vascular, Inc. Aneurysm devices with additional anchoring mechanisms and associated systems and methods
US10004510B2 (en) 2011-06-03 2018-06-26 Pulsar Vascular, Inc. Systems and methods for enclosing an anatomical opening, including shock absorbing aneurysm devices
US9636117B2 (en) 2011-10-05 2017-05-02 Pulsar Vascular, Inc. Devices, systems and methods for enclosing an anatomical opening
US10426487B2 (en) 2011-10-05 2019-10-01 Pulsar Vascular, Inc. Devices, systems and methods for enclosing an anatomical opening
US9119625B2 (en) 2011-10-05 2015-09-01 Pulsar Vascular, Inc. Devices, systems and methods for enclosing an anatomical opening
US11457923B2 (en) 2011-10-05 2022-10-04 Pulsar Vascular, Inc. Devices, systems and methods for enclosing an anatomical opening
US9259229B2 (en) 2012-05-10 2016-02-16 Pulsar Vascular, Inc. Systems and methods for enclosing an anatomical opening, including coil-tipped aneurysm devices
CN111612860A (zh) * 2019-02-22 2020-09-01 未艾医疗技术(深圳)有限公司 基于VRDS 4D医学影像的栓塞的Ai识别方法及产品
CN111612860B (zh) * 2019-02-22 2023-09-15 曹生 基于VRDS 4D医学影像的栓塞的Ai识别方法及产品

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