WO2020122978A1 - Cathéter de thrombectomie et procédés d'utilisation - Google Patents

Cathéter de thrombectomie et procédés d'utilisation Download PDF

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Publication number
WO2020122978A1
WO2020122978A1 PCT/US2019/030087 US2019030087W WO2020122978A1 WO 2020122978 A1 WO2020122978 A1 WO 2020122978A1 US 2019030087 W US2019030087 W US 2019030087W WO 2020122978 A1 WO2020122978 A1 WO 2020122978A1
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WO
WIPO (PCT)
Prior art keywords
lumen
pigtail
catheter
aspiration
surgical device
Prior art date
Application number
PCT/US2019/030087
Other languages
English (en)
Inventor
Eric Raul GUERRA
Xochitl Brahms GUERRA
Mayra Paulina GUERRA
Original Assignee
Guerra Eric Raul
Guerra Xochitl Brahms
Guerra Mayra Paulina
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
Priority claimed from US16/221,471 external-priority patent/US11229451B2/en
Application filed by Guerra Eric Raul, Guerra Xochitl Brahms, Guerra Mayra Paulina filed Critical Guerra Eric Raul
Priority to MX2021007034A priority Critical patent/MX2021007034A/es
Priority to CN201980091500.1A priority patent/CN113423451B/zh
Priority to KR1020217021427A priority patent/KR20210118392A/ko
Priority to BR112021011486-6A priority patent/BR112021011486A2/pt
Priority to CA3122708A priority patent/CA3122708A1/fr
Priority to JP2021556209A priority patent/JP2022524892A/ja
Priority to EP19897249.9A priority patent/EP3893981A4/fr
Publication of WO2020122978A1 publication Critical patent/WO2020122978A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—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
    • A61B17/32—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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • 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
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00331—Steering mechanisms with preformed bends
    • 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
    • A61B2017/00358—Snares for grasping
    • 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
    • A61B2017/22038—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 with a guide wire
    • 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
    • A61B2017/22038—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 with a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A61B2017/22044—Details of the tip of the guide wire with a pointed tip
    • 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
    • A61B2017/22079—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 with suction of debris
    • 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
    • A61B2017/22094—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 for crossing total occlusions, i.e. piercing
    • 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
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320716—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions comprising means for preventing embolism by dislodged material
    • 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
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320733—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a flexible cutting or scraping element, e.g. with a whip-like distal filament member

Definitions

  • the disclosure relates generally to medical catheter devices and more specifically it relates to medical catheter devices with a deployable instrument to remove thrombi (blood clots).
  • a catheter is a medical device or apparatus made from medical grade materials serving a broad range of functions, such as insertion into the body to treat diseases or perform a surgical procedure.
  • catheters are often of an elongated form having manipulator means at its distal end and utilized for surgical manipulation of matter in a confined or inaccessible space within a human body or animal.
  • catheters may be utilized to perform suturing, cutting with a knife or scissor action, or by capture and retrieval devices through a small arthroscopic, endoscopic incision, percutaneous, or body aperture.
  • angioplasty, atherectomy, and deployment of stents and stent-grafts procedures to treat vascular disease, often dislodge material or plaque from the vessel walls, which may result in the formation of clots or the release of emboli, which enter the bloodstream, and may be large enough to occlude smaller downstream vessels and potentially blocking blood flow to tissue.
  • the result may pose a serious threat to the health or life of a patient if the blockage occurs in critical tissue, such as the heart, lungs, or brain.
  • One previous approach includes a catheter device having a cannula with an axial bore wherein a remote actuator means on a proximate end activates a sliding elastically deformable loop to extend past the confines of the deployment opening on the distal end thereof to deploy the elastically deformable loop and barrier member attached thereto and attains its deployed configuration.
  • a remote actuator means on a proximate end activates a sliding elastically deformable loop to extend past the confines of the deployment opening on the distal end thereof to deploy the elastically deformable loop and barrier member attached thereto and attains its deployed configuration.
  • the elastically deformable loop may over expand or linearly expand causing a tear in tissue or a vessel in the deployment area.
  • Another disadvantage of this approach is that the elastically deformable loop may slice or puncture the biopsy, clot, or impaling the vessel wall when the sliding elastically deformable loop is expanded and/or retracted back into the deployment opening.
  • such elastically deformable loop is generally incapable of preventing material
  • Another previous approach includes a catheter device having self-expanding vascular device, such as a support hoop expandable to an articulation region for supporting a sac or mesh filter for filtering or removing matter and capturing emboli from within a vascular system.
  • self-expanding vascular device such as a support hoop expandable to an articulation region for supporting a sac or mesh filter for filtering or removing matter and capturing emboli from within a vascular system.
  • the mesh filter may degrade flow through the vessel and may result in damage to the downstream cells and tissue normally fed by the blocked vessel. Consequently, it may be difficult or impossible to use such devices in small diameter vessels.
  • a thrombectomy catheter and methods of use thereof that functions to deploy, scoop, collect, and remove material, plaque, clots, and emboli from the vessel walls without causing a tear in tissue or a vessel, slice or puncture the biopsy, clot, or impale the vessel wall.
  • a filter carrier member
  • to prevent material from escaping from the filter (barrier member) during the process of collapsing and retraction not degrade flow through the vessel and may result in damage to the downstream cells and tissue normally fed by the blocked vessel, and enable operation in small diameter vessels.
  • the present apparatus overcomes the above-mentioned disadvantage, and meets the recognized need for a thrombectomy catheter and methods of use, by providing a catheter or delivery sheath having a dual lumen (passageway) extending therethrough, the catheter having a proximal segment and a distal segment and a linear section coupled therebetween, the distal segment configured as a loop (pigtail) or rim, a port or aperture formed therein said dual lumen of said catheter, the port positioned proximate the distal segment, and a guidewire configured to longitudinally traverse therethrough one of the dual lumen of the catheter, said guidewire configured with a mesh strainer (basket/net) configured to longitudinally traverse therethrough the other of the dual lumen of the catheter and exit therethrough said port and follow said loop to form retractable mesh strainer and, thus, functions to deploy, scoop, collect, and remove material, plaque, clots, and emboli from the vessel interior without causing a tear in tissue or a vessel,
  • a mesh strainer
  • the thrombectomy catheter and methods of use includes a catheter or delivery sheath having a dual lumen extending therethrough, the catheter having a proximal segment and a distal segment and a linear section coupled therebetween, the distal segment configured as a loop, a port or aperture formed therein said dual lumen of said catheter, the port positioned proximate the distal segment, and a guidewire configured to longitudinally traverse therethrough one of the dual lumen of the catheter, said guidewire having a first end affixed to a mesh strainer, the mesh strainer configured to longitudinally traverse therethrough the other of the dual lumen of the catheter and exit therethrough said port and follow said loop to form retractable mesh strainer.
  • the remotely operated surgical device includes a flexible positioning instrument having an elongated catheter with a dual lumen bore therein extending from a first catheter end to a second catheter end, the dual lumen bore having a first lumen and a second lumen, and a pigtail attached thereto the second catheter end, the first lumen extends therethrough the elongated catheter and the pigtail, the second lumen extends therethrough the elongated catheter, a guidewire extendable therethrough the first lumen of the elongated catheter and the pigtail, and extendable therefrom the pigtail, the guidewire configured to angle the pigtail, and a retraction instrument configured having a proximal member and a distal member coupled to the proximal member, the distal member having a deformable rim and a barrier membrane affixed thereto the deformable rim and extendable therethrough the second lumen of the elongated catheter.
  • the flexible positioning instrument having an elongated catheter with a dual lumen bore therein extending from a first catheter end to a second catheter end, the dual lumen bore having a first lumen and a second lumen, and a pigtail attached thereto the second catheter end, the first lumen extends therethrough the elongated catheter and the pigtail, the second lumen extends therethrough the elongated catheter, a guidewire extendable therethrough the first lumen of the elongated catheter and the pigtail, and a retraction instrument configured having a proximal member and a distal member coupled to the proximal member, the distal member having a deformable rim and a barrier membrane affixed thereto the deformable rim and extendable therethrough the second lumen of the elongated catheter, maneuvering the operated surgical device therethrough the
  • a feature of the thrombectomy catheter and methods of use is its ability to spin the pigtail or distal segment configured as a loop multiple times proximate the undesirable material enabling it to scoop up clots, plaque, emboli, thrombi (blood clots), fatty deposit, or other undesirable material or debris therein mesh blood strainer and extract them from a human blood vessel.
  • Another feature of the thrombectomy catheter and methods of use is its ability to provide a mesh strainer or basket porous so that blood cells may pass through freely while clots, plaque, emboli, thrombi (blood clots), fatty deposit, or other undesirable material or debris are captured therein.
  • Still another feature of the thrombectomy catheter and methods of use is its ability to provide a dual lumen catheter where one lumen forms a passageway for the guidewire and the other lumen forms a passageway for the mesh strainer.
  • Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a remotely operable surgical device or guidewire.
  • Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a flexible a dual lumen catheter.
  • Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a flexible a dual lumen catheter having a flexible pigtail having a passageway for the guidewire and a deployment or exit port formed proximate or at the tip end.
  • Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a retractable mesh strainer that traverses therearound the distal segment configured as a loop to form a basket or net to scoop up clots, plaque, emboli, or other dislodge matter therein mesh strainer.
  • Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device that is capable of being contracted to a small delivery profile, thus permitting use of the device in small blood vessels.
  • Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device without the need for specialized delivery catheters.
  • Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device to provide a vascular device that reduces the risk of clots, plaque, emboli, thrombi (blood clots), fatty deposit, or other undesirable material or debris escaping from the device when the device is retracted and removed.
  • Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device to percutaneously remove clots, plaque, emboli, thrombi (blood clots), fatty deposit, or other undesirable material or debris from human blood vessel without performing surgery or without giving a clot buster.
  • Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device to capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, or other undesirable material or debris from human blood vessel just by spinning the pigtail, loop, or distal segment configured as a loop multiple times proximate the undesirable material.
  • Yet another feature of the thrombectomy catheter and methods of use is the ability to remove the net, basket, deployable mesh basket, or mesh strainer multiple times through the dual lumen catheter without losing position of the pigtail, loop, or distal segment configured as a loop adjacent to the working area.
  • thrombectomy catheter and methods of use is the ability to provide a vascular device with aspiration or suction via an aspiration device to collect and remove clots, plaque, emboli, thrombi (blood clots), fatty deposit, or other undesirable material or debris from human blood vessel by suctioning undesirable material (aspiration thrombectomy) therein a distal end of a lumen proximate the undesirable material and drawing such down the lumen channel.
  • FIG. 1A is a top perspective view of an exemplary embodiment of a thrombectomy catheter
  • FIG. IB is a perspective cross-sectional view of an exemplary embodiment of a dual lumen elongated catheter of the thrombectomy catheter of FIG. 1A;
  • FIG. 1C is a perspective cross-sectional view of an exemplary embodiment of a single lumen pigtail of the thrombectomy catheter of FIG. 1A;
  • FIG. 2 is a top perspective view of an exemplary embodiment of the thrombectomy catheter of FIG. 1A, shown with a guidewire passing therein a first lumen elongating the pigtail;
  • FIG. 3 is a top perspective view of an exemplary embodiment of vascular medical instrument
  • FIG. 4A is a top perspective view of an exemplary embodiment of a thrombectomy catheter of FIG. 1, shown with a guidewire traversing therein first lumen, and retractable instrument traversing therein second lumen;
  • FIG. 4B is a perspective cross-sectional view of the elongated catheter of a thrombectomy catheter of FIG. 1, shown with a guidewire and a retractable instrument traversing therethrough;
  • FIG. 5A is a top perspective view of an exemplary thrombectomy catheter of FIG. 1 with retractable instrument deployed therebetween pigtail;
  • FIG. 5B is a front perspective view of thrombectomy catheter of FIG. 5A with vascular medical instrument, shown netting undesirable material or debris for retrieval;
  • FIG. 6 is a top view of thrombectomy catheter of FIG. 5A passing through the heart and deployed in a vascular vessel of the lung with retractable instrument shown netting undesirable material or debris for retrieval;
  • FIG. 7 is a flow diagram of a method deploying, using, and retrieving thrombectomy catheter of FIGs. 1-6 to remove undesirable material or debris from a vascular vessel;
  • FIG. 8 is a top perspective view of an exemplary embodiment of a thrombectomy catheter with aspiration device
  • FIG. 9 is a top perspective view of an exemplary thrombectomy catheter of FIG. 8 with undesirable material being drawn therein lumen distal end
  • FIG. 10 is a flow diagram of a method deploying, using, and retrieving thrombectomy catheter of FIGs. 1-6 and 8-9 to remove undesirable material or debris from a vascular vessel via aspiration.
  • FIGS. 1A, IB, 1C, 2, 3, 4A, 4B, 5A, 5B, 6 7, 8, 9, and 10 specific terminology is employed for the sake of clarity.
  • the present disclosure is not intended to be limited to the specific terminology so selected, and it is to be understood that each specific element includes all technical equivalents that operate in a similar manner to accomplish similar functions.
  • Embodiments of the claims may, however, be embodied in many different forms and should not be construed to be limited to the embodiments set forth herein.
  • the examples set forth herein are non-limiting examples, and are merely examples among other possible examples.
  • Surgical positioning instrument 10 may include a base section, such as hand grip 36, having first rotation flap 37 and second rotation flap 38, as coupled to a longitudinal linear member, cannula, housing, catheter, or sheath, such as elongated catheter 20 extending linearly therefrom hand grip 36.
  • elongated catheter 20 may include two or dual axial bores therethrough or space created inside elongated catheter 20 and extending from first catheter end 21 to second catheter end 22.
  • two or dual axial bores therethrough may include first lumen 31 and second lumen 32 separated by divider 33.
  • second catheter end 22 of surgical positioning instrument 10 may be configured as a loop, open ended loop, or enclosure, such as pigtail 50 formed thereon or attached thereto second catheter end 22.
  • pigtail 50 may be formed in a variety of sizes and configurations and include first pigtail section 51 and second pigtail section 52 with first pigtail section 51 affixed thereto second catheter end 22 of elongated catheter 20 and second pigtail section 52 forming an enclosure that loops around back to a position proximate second catheter end 22.
  • elongated catheter 20 and pigtail 50 may preferably be configured or constructed of plastic, polymeric material includes polytetrafluorethylene, polyurethane, polyethylene, Teflon, and the like as such materials offers a variety of forms, shapes, ease of manufacture, and flexibility; however, other suitable materials may be utilized provided such material has sufficient strength, flexibility, and/or durability as would meet the purpose described herein.
  • the material of elongated catheter 20, second lumen 32 pigtail 50, second lumen or medical instrument exit aperture 25 may be reinforced with fibers, rings, or longitudinal ribs, for example, to enable it to withstand the forces exerted on it by retractable instrument 60 while it is constrained within second lumen 32 and deformed by elongated catheter 20.
  • First lumen 31 may extend therethrough hand grip 36, elongated catheter 20, and pigtail 50, beginning with an entrance hole, such as first lumen or guidewire entrance aperture 24 and exit therefrom pigtail 50 proximate pigtail end 53 through an exit or deployment hole opening to the environment, such as first lumen or guidewire exit aperture 26.
  • Second lumen 32 may extend therethrough hand grip 36 and elongated catheter 20 beginning with an entrance hole, such as first instrument aperture 23 and exit therefrom elongated catheter 20 proximate second catheter end 22 through an exit or deployment hole, such as second instrument aperture 25 proximate second catheter end 22.
  • Guidewire 40 for deployment and retraction use therein first lumen 31 of elongated catheter 20 and pigtail lumen 31B of pigtail 50.
  • Guidewire 40 may include first guidewire end 41 and second guidewire end 42.
  • a path or vessel guiding device such as guidewire 40 may be extended therethrough first lumen 31 of elongated catheter 20 and pigtail lumen 31B of pigtail 50 beginning with an entrance hole, such as first lumen entrance aperture 24 and exiting therefrom pigtail 50 proximate pig tail end 53 through an exit or deployment hole opening to the environment, such as first lumen exit aperture 26 to a position beyond or extend and extendable therefrom pigtail 50 to assist or guide second catheter end 22 and pigtail 50 therethrough a blood vessel V, turn, fork or other vascular maneuverability.
  • First guidewire end 41 extends through the deployment opening, such as guide wire aperture 26 and is remotely controlled from second guidewire end 42.
  • pigtail 50 may angled or straighten (as shown in FIG. 2) or angle, such as pigtail angle A (from approximately 0-270 degrees relative to perpendicular thereto elongated catheter 20, 9 o’clock counterclockwise to 12 o’clock), depending on the flexibility or rigidity of first guidewire end 41 passing therethrough.
  • first rotation R1 of elongated catheter 20 causes or results in similar rotation, such as rotation R2 of pigtail 50.
  • Both pigtail angle A and rotation R2 enable a variety of positions of first guidewire end 41 to assist or guide or position guidewire 40, pigtail 50, and second catheter end 22 therethrough a blood vessel V, turn, fork or other vascular maneuverability.
  • movement of or moving guidewire 40 causes first guidewire end 41 to move in and out therefrom guide wire aperture 26 to assist or guide or position guidewire 40, pigtail 50, and second catheter end 22 therethrough a blood vessel, turn, fork or other vascular V maneuverability.
  • first lumen 31 and pigtail lumen 31B may be utilized as an access for additional laparoscopic or endoscopic devices, and/or fluid access or withdrawal, lighting, video, and like medical instruments 40A.
  • Such an endoscope can also provide surgical implements such as lasers, scalpels, irrigation and aspiration means, visualization means, and the like 40A.
  • the specific configuration and dimensions of first lumen 31 and pigtail lumen 31B will vary with the intended use of surgical positioning instrument 10, and whether access for additional medical instruments 40A is provided.
  • Retractable instrument 60 may include a proximal or elongated member or operator, such as proximal member 64 having a first member end 65 and a second member end 66.
  • First member end 65 may be configured having a loop, enclosure, or basket, pigtail such as deformable rim 67 configured thereon and proximate second member end 66. It is contemplated herein that deformable rim 67 may be configured in a variety of sizes and shapes preferably matching pigtail 50 in size and shape.
  • deformable rim 67 may be configured of one or two components, such as first deformable section 61 and second deformable section 62 and may alternatively include one or more pivot joint 68 therebetween first deformable section 61 and second deformable section 62.
  • Deformable rim 67 is preferably made of a flexible, elastic, or shape memory material or alloy biocompatible material capable of flexing, bending, or collapsing to a configuration which may enter and exit first instrument aperture 23, traverse axial bore of second lumen 32, expanding to deployed net after passing therethrough second instrument aperture 26, and collapsing to re-enter second instrument aperture 26 to extract biomaterial therefrom a blood vessel or other vascular channel or conduit V.
  • deformable rim 67 may include one or more joints or hinges, such as pivot point 68 positioned therearound deformable rim 67 or between first deformable section 61 and second deformable section 62 to enable deformable rim 67, first deformable section 61, and second deformable section 62 to linearly collapse or fold and traverse therethrough first instrument aperture 23, axial bore of second lumen 32, and second instrument aperture 25. It is still further contemplated herein that deformable rim 67 may form an opening, such as rim inlet 69.
  • deformable rim 67 When expanded, deformable rim 67 may have a diameter of from about 1 cm or less to about 3 cm but other sizes are contemplated herein.
  • a barrier membrane or other sifting or filtering membrane, such as mesh strainer 63 preferably runs, spans, or is affixed thereto deformable rim 67 loosely, forming a rounded open end capture net across rim inlet 69.
  • Mesh strainer 63 may be utilized to filter or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, or other undesirable material or debris from within human blood vessels y.
  • axial bore of second lumen 32 The specific configuration and dimensions of axial bore of second lumen 32 will vary with the use of surgical positioning instrument 10, the parameters of retractable instrument 60, such as insertion/retraction member 64 and sized to receive deformable rim 67 having first deformable section 61 and second deformable section 62 in a constrained configuration with mesh strainer 63 furled around first deformable section 61, second deformable section 62, and insertion/retraction member 64.
  • second lumen 32 may be utilized as an access for additional laparoscopic or endoscopic devices, and/or fluid access or withdrawal, lighting, video, and like medical instruments 40A.
  • Such an endoscope can also provide surgical implements such as lasers, scalpels, irrigation and aspiration means, visualization means, and the like 40A.
  • the outer diameter of the catheter 20 may vary with the application, the size of first lumen 31 and second lumen 32, the size of deformable rim 67 of retractable instrument 60 having first deformable section 61 and second deformable section 62, whether access for additional laparoscopic or endoscopic devices, and/or fluid access or withdrawal, lighting, video, and the like 40A, and whether additional lumens are included in surgical positioning instrument 10.
  • retractable instrument 60 for deployment and retraction use therein second lumen 32 of surgical positioning instrument 10.
  • second guidewire end 42 may be pulled and as guidewire 40 retracts therethrough pigtail 50, pigtail 50 may return to pigtail or loop configuration as shown in FIGs. 1 and 4A.
  • deformable rim 67 of first member end 65 may be preferably collapsed and mesh strainer 63 may be furled or wrapped therearound deformable rim 67 and/or first member end 65 of retractable instrument 60. Collapsed deformable rim 67 and furled mesh strainer 63 may be inserted therein first instrument aperture 23 of second lumen 32. Collapsed deformable rim 67 and furled mesh strainer 63 may be disposed within, extended, and traverse therethrough second lumen 32 of elongated catheter 20 and exit or deploy therethrough or extendable therefrom.
  • deformable rim 67 Upon deformable rim 67 and furled mesh strainer 63 exit thereof second lumen 32, deformable rim 67 expands to deployed deformable rim 67 with mesh strainer 63 unfurled to an expanded collection state positioned proximate pigtail 50.
  • first deformable section 61 and second deformable section 62 of deformable rim 67 expand back to a non-compressed position as shown in FIG. 5 to create expanded deformable rim 67 having rim inlet 69 and mesh strainer 63, where expanded deformable rim 67 preferably mates up with or may be positioned proximate or within pigtail 50, as shown in FIG. 5.
  • FIG. 5A and 5B by way of example, and not limitation, there is illustrated an example embodiment of retractable instrument 60 shown deployed therefrom second lumen 32 of surgical positioning instrument 103
  • push/pull PI of second member end 66 may deploy or extend deformable rim 67 within pigtail 50 or past the confines of second instrument aperture 25 on the distal end thereof second catheter end 22 to deploy deformable rim 67 and mesh strainer 63 attached thereto and attains its deployed configuration.
  • Rotation R3 of second member end 66 causes or results in similar rotation, such as rotation R4 of deformable rim 67 having rim inlet 69 and mesh strainer 63, which in turn causes deformable rim 67 having rim inlet 69 and mesh strainer 63 of retractable instrument 60 to scoop up or collect or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V.
  • rotation R1 of elongated catheter 20 results in rotation R2 of pigtail 50 which in turn results in rotation R4 of deformable rim 67 having rim inlet 69 and mesh strainer 63 due to abutting or contact therebetween pigtail 50 and deformable rim 67 (deformable rim 67 abuts pigtail 50), which in turn causes deformable rim 67 having rim inlet 69 and mesh strainer 63 of retractable instrument 60 to scoop up or collect or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V.
  • Undesirable material or debris M may be removed from blood vessel V by extracting retractable instrument 60 and deformable rim 67 having rim inlet 69 and mesh strainer 63 containing undesirable material or debris M back therein second instrument aperture 25 collapsing deformable rim 67 and pulling retractable instrument 60 down second lumen 32 of surgical positioning instrument 10 and out first instrument aperture 23, as shown in FIGs. 4A and 4B.
  • Push/pull PI of second member end 66 may retrieve deformable rim 67 by collapsing deformable rim 67 and mesh strainer 63 may be furled or wrapped therearound deformable rim 67 and/or first member end 65, and retractable instrument 60 with undesirable material or debris M may be pulled therethrough second instrument aperture 25 and exit out first instrument aperture 23.
  • deformable rim 67 and pigtail 50 may be similar or matched in size and shape, such as circumference and/ or diameter, to enable abutting or contact therebetween pigtail 50 and deformable rim 67 (deformable rim 67 abuts pigtail 50).
  • surgical positioning instrument 10 shown with pigtail 50 inserted into a patient and serpentinely deployed therethrough blood vessel V, heart H, lung L, and into lung blood vessel V. It is contemplated herein that surgical positioning instrument 10 may be deployed therein any fluid-carrying vessels where debris needs to be removed.
  • push/pull PI of guidewire 40 may be extended therethrough pigtail 50, causing pigtail 50 to straighten or elongate (as shown in FIG. 2) or angle, such as pigtail angle A, therein blood vessel V depending on the flexibility or rigidity of first guidewire end 41 passing therethrough.
  • first rotation R1 of elongated catheter 20 causes pigtail 50 to similarly rotate, rotation R2 therein blood vessel V.
  • Both pigtail angle A and rotation R2 enable a variety of positions of first guidewire end 41 to assist or guide or position guidewire 40, pigtail 50, and second catheter end 22 therethrough or therein blood vessel V, heart H, lung L to serpentine, turn, maneuver a fork of or other vascular maneuverability to precisely maneuver and position pigtail 50 therein blood vessel V.
  • the objective of surgical positioning instrument 10 is to preferably position pigtail 50 in a specific location within a patient's vessel.
  • Push/pull PI of second member end 66 results in exit or deployment of deformable rim 67 having rim inlet 69 and mesh strainer 63 therethrough second instrument aperture 25 proximate a junction between second catheter end 22, and expanding to deployed deformable rim 67 with mesh strainer 63 after passing therethrough second instrument aperture 25 to a position proximate pigtail 50 therein blood vessel V.
  • rotation R3 of second member end 66 results in rotation R4 of deformable rim 67 within blood vessel V having rim inlet 69 and mesh strainer 63, which in turn causes deformable rim 67 having rim inlet 69 and mesh strainer 63 of retractable instrument 60 to scoop up or collect or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V.
  • rotation R1 of elongated catheter 20 results in rotation R2 of pigtail 50 within blood vessel V which in turn results in rotation R4 of deformable rim 67 having rim inlet 69 and mesh strainer 63 due to abutting or contact therebetween pigtail 50 and deformable rim 67, which in turn causes deformable rim 67 having rim inlet 69 and mesh strainer 63 of retractable instrument 60 to scoop up or collect or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V.
  • Push/pull PI of second member end 66 results in collapsed deformable rim 67 having rim inlet 69 and mesh strainer 63 being retracted or entry therein second instrument aperture 25 and traversing therethrough second lumen 32 to first instrument aperture 23 to remove undesirable material or debris M captured therein mesh strainer 63 from blood vessel V. It is contemplated herein that such capture and retrieval of undesirable material or debris M may be accomplished multiple times with multiple passes, deployment, retract, and retrieval of retractable instrument 60 therethrough second lumen 32 of surgical positioning instrument 10.
  • second lumen 32 angioplasty, atherectomy, and deployment of stents and stent-grafts, procedures to treat vascular disease may be deployed therethrough second lumen 32.
  • Such instruments often dislodge material or plaque from the vessel walls of blood vessel V, which may result in the formation of clots or the release of emboli, biomaterial, such as undesirable material or debris M, which enter the bloodstream, and may be large enough to occlude smaller downstream vessels and potentially blocking blood flow to tissue. The result may pose a serious threat to the health or life of a patient if the blockage occurs in critical tissue, such as the heart, lungs, or brain.
  • Retractable instrument 60 may be utilized herein to traverse second lumen 32 to capture and remove undesirable material or debris M from blood vessel V.
  • pigtail 50 encircling of deformable rim 67 may protect blood vessel V when deformable rim 67 expands preventing contact therewith blood vessel V preventing a tear in tissue or a vessel in the deployment area.
  • pigtail 50 encircling of deformable rim 67 may protect blood vessel V when deformable rim 67 expands or retracts preventing contact therewith blood vessel V preventing slice or puncture the biopsy, clot, or impaling the vessel wall of blood vessel V.
  • second lumen 32 may be utilized for delivery of other medical instmment(s), such as a suture to conduct a biopsy or other medical instrument to meet the needs of the medical application being performed with surgical positioning instrument 10.
  • second lumen 32 may be sized or configured adjustable to accommodate different diameter or sized medical instruments 60.
  • FIG. 7 there is illustrated a flow diagram 700 of utilizing surgical positioning instrument 10 and retractable instrument 60 to remove clots or the release of emboli, biomaterial, such as undesirable material or debris M from blood vessel V.
  • block or step 710 providing surgical positioning instrument 10 having elongated member 20 with two or dual axial bores therethrough, such as first lumen 31 and second lumen 32, and pigtail 50 on one end and integral retractable instrument 60 having deformable rim 67 and mesh strainer 63 as described above in FIGS.
  • step 715 manipulating or moving guidewire 40 (push/pull PI of guidewire 40 or rotate R1 elongated member 20) to alter the position of pigtail 50 for a path or vessel guiding device to maneuver or advance surgical positioning instrument 10 therethrough blood vessel V, turn, fork or other vascular maneuverability and positioning pigtail 50 proximate material or debris M.
  • step 720 deploying retractable instrument 60 via expanding deployed deformable rim 67 with mesh strainer 63 after passing therethrough second instrument aperture 25 to a position proximate pigtail 50 (deploying deformable rim 67 and mesh strainer 63 therefrom second lumen 32).
  • first deformable section 61 and second deformable section 62 of deformable rim 67 expands back to a non-compressed position.
  • rotating deformable rim 67 and mesh strainer 63 proximate material or debris M via rotating elongated catheter 20, rotation Rl results in rotation R2 of pigtail 50 which in turn results in rotation R4 of deformable rim 67 having rim inlet 69 and mesh strainer 63 due to abutting or contact therebetween pigtail 50 and deformable rim 67, which in turn causes deformable rim 67 having rim inlet 69 and mesh strainer 63 of retractable instrument 60 to scoop up or collect or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V.
  • step 735 collecting material or debris M therein mesh strainer 63 via scooping up or collecting or capturing clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V therein mesh strainer 63.
  • retracting deformable rim 67, mesh strainer 63, and material or debris M therethrough second instrument aperture 25 of second lumen 32 via collapsing deformable rim 67 by push/pull PI of second member end 66 to retrieve collapsing deformable rim 67 and mesh strainer 63 may be furled or wrapped therearound deformable rim 67 and/or first member end 65, and retractable instrument 60 with undesirable material or debris M may be pulled therethrough or entry therein second instrument aperture 25 and exit out first instrument aperture 23.
  • Surgical positioning instrument 10 may include access hub or port, such as aspiration port 90 positioned proximate hand grip 36 or first catheter end 21. Aspiration port 90 may provide access, may be connected, in communication thereto first lumen 31 running the length thereof elongated catheter 20, pigtail lumen 31B of pigtail 50, and thereto pigtail end 53. Moreover, surgical positioning instrument 10 may include a side arm or conduit, such as aspiration tube 80 which may include a distal end, such as first tube end 81 and a proximate end, or second tube end 82.
  • access hub or port such as aspiration port 90 positioned proximate hand grip 36 or first catheter end 21. Aspiration port 90 may provide access, may be connected, in communication thereto first lumen 31 running the length thereof elongated catheter 20, pigtail lumen 31B of pigtail 50, and thereto pigtail end 53.
  • surgical positioning instrument 10 may include a side arm or conduit, such as aspiration tube 80 which may include a distal end,
  • Second tube end 82 may be affixed or removeably affixed thereto aspiration port 90.
  • Aspiration tube 80 may include three way stop cock valve 84 with cock bar 85.
  • Cock bar 85 may be rotated (rotational) between open position for passage therethrough and for suction, diversion position to divert debris M to threaded port and cap 83, and closed position to seal second tube end 82.
  • surgical positioning instrument 10 may include a suction, vacuum or negative pressure device, such as aspiration device 70.
  • Aspiration device 70 may include a syringe having a housing or body such as syringe barrel 72, plunger 71 positioned therein and drawn or moved, such as as movement M therein syringe barrel 72, and adapter port 73 provides an exit or entrance thereto syringe barrel 72.
  • Aspiration device 70 or more specifically adapter port 73 may be connected, in communication, or removeably connected thereto first tube end 81 preferably to perform aspiration, vacuum, or suction S therethrough aspiration tube 80, aspiration port 90, lumen 31 of elongated catheter 20, pigtail lumen 31B of pigtail 50, and therethrough pigtail end 53.
  • pigtail 50 shown proximate clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M within blood vessel V.
  • aspiration or suction thereby aspiration device 70 preferably results in debris M being suctioned in or drawn or pulled (pulls/suctions) or collected or captured therein pigtail end 53.
  • debris M may be pulled or traverse pigtail lumen 31B of pigtail 50, lumen 31 of elongated catheter 20, aspiration port 90, and aspiration tube 80, thereto aspiration device 70 whereby debris M has been removed therefrom blood vessel y.
  • pigtail 50 may be in an extended configuration as shown in FIG. 2 rather than in a curled configuration as shown in FIGs. 5 during aspiration or suction (aspiration thrombectomy) of debris M.
  • FIG. 10 there is illustrated a flow diagram 1000 of utilizing surgical positioning instrument 10 and retractable instrument 60 to remove clots or the release of emboli, biomaterial, such as undesirable material or debris M from blood vessel V via aspiration or suction.
  • block or step 1010 providing surgical positioning instrument 10 having elongated member 20 with two or dual axial bores therethrough, such as first lumen 31 and second lumen 32, and pigtail 50 on one end and aspiration port 90, aspiration tube 80, and aspiration device 70 as described above in FIGS. 8-9.
  • step 1015 manipulating or moving first catheter end 21 to alter the position of pigtail 50 for a path or vessel guiding device to maneuver or advance surgical positioning instrument 10 therethrough blood vessel V, turn, fork or other vascular maneuverability and positioning pigtail 50 proximate material or debris M, block or step 1020.
  • aspiration device 70 (aspirating or suctioning) for collecting, capturing, debris M therein pigtail end 53. Furthermore with continued aspiration or suction step 1040 (aspiration thrombectomy) thereby aspiration device 70 debris M may be pulled or traverse pigtail lumen 31B of pigtail 50, lumen 31 of elongated catheter 20, aspiration port 90, and aspiration tube 80, thereto aspiration device 70 step 1050 whereby debris M has been removed therefrom blood vessel V.

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Abstract

L'invention concerne un cathéter de thrombectomie avec un cathéter ou une gaine de distribution à deux lumières le traversant, le cathéter ayant un segment proximal et un segment distal et une section linéaire couplée entre eux, le segment distal étant conçu sous la forme d'une boucle, d'un orifice ou d'une ouverture à l'intérieur des deux lumières dudit cathéter, l'orifice étant positionné à proximité du segment distal, et un fil-guide étant conçu pour traverser longitudinalement l'une des deux lumières du cathéter, un dispositif d'aspiration étant connecté à une des deux lumières et conçu pour produire un vide dans le cathéter et la boucle pour en extraire un biomatériau.
PCT/US2019/030087 2018-12-15 2019-05-01 Cathéter de thrombectomie et procédés d'utilisation WO2020122978A1 (fr)

Priority Applications (7)

Application Number Priority Date Filing Date Title
MX2021007034A MX2021007034A (es) 2018-12-15 2019-05-01 Cateter de trombectomia y metodos de uso.
CN201980091500.1A CN113423451B (zh) 2018-12-15 2019-05-01 取栓导管及使用方法
KR1020217021427A KR20210118392A (ko) 2018-12-15 2019-05-01 혈전절제 카테터 및 사용 방법
BR112021011486-6A BR112021011486A2 (pt) 2018-12-15 2019-05-01 Cateter de trombectomia e métodos de uso
CA3122708A CA3122708A1 (fr) 2018-12-15 2019-05-01 Catheter de thrombectomie et procedes d'utilisation
JP2021556209A JP2022524892A (ja) 2018-12-15 2019-05-01 血栓摘出カテーテルおよび使用方法
EP19897249.9A EP3893981A4 (fr) 2018-12-15 2019-05-01 Cathéter de thrombectomie et procédés d'utilisation

Applications Claiming Priority (2)

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US16/221,471 2018-12-15
US16/221,471 US11229451B2 (en) 2017-12-13 2018-12-15 Thrombectomy catheter and methods of use

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BR (1) BR112021011486A2 (fr)
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US20160095523A1 (en) * 2004-03-10 2016-04-07 Phil Langston Coaxial dual lumen pigtail catheter
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EP3893981A4 (fr) 2022-08-10
BR112021011486A2 (pt) 2021-08-31
CN113423451B (zh) 2023-07-28
JP2022524892A (ja) 2022-05-10
EP3893981A1 (fr) 2021-10-20
CA3122708A1 (fr) 2020-06-18
KR20210118392A (ko) 2021-09-30
MX2021007034A (es) 2021-10-22

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