EP4577131A1 - Systèmes d'élimination de thrombus et procédés associés - Google Patents

Systèmes d'élimination de thrombus et procédés associés

Info

Publication number
EP4577131A1
EP4577131A1 EP23858292.8A EP23858292A EP4577131A1 EP 4577131 A1 EP4577131 A1 EP 4577131A1 EP 23858292 A EP23858292 A EP 23858292A EP 4577131 A1 EP4577131 A1 EP 4577131A1
Authority
EP
European Patent Office
Prior art keywords
imaging
funnel
imaging marker
marker
thrombus
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.)
Pending
Application number
EP23858292.8A
Other languages
German (de)
English (en)
Inventor
Aadel Al-Jadda
Amr Salahieh
Paul Gunning
Muralidharan Srivathsa
Uday Illindala
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.)
Shifamed Holdings LLC
Original Assignee
Shifamed Holdings LLC
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 Shifamed Holdings LLC filed Critical Shifamed Holdings LLC
Publication of EP4577131A1 publication Critical patent/EP4577131A1/fr
Pending 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
    • A61B17/22—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
    • 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
    • A61B17/3203—Fluid jet cutting instruments
    • A61B17/32037—Fluid jet cutting instruments for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • 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 present technology generally relates to medical devices and, in particular, to systems including aspiration and fluid delivery mechanisms and associated methods for removing a thrombus from a mammalian blood vessel.
  • Thrombotic material may lead to a blockage in fluid flow within the vasculature of a mammal. Such blockages may occur in varied regions within the body, such as within the pulmonary system, peripheral vasculature, deep vasculature, or brain. Pulmonary embolisms typically arise when a thrombus originating from another part of the body (e.g., a vein in the pelvis or leg) becomes dislodged and travels to the lungs.
  • another part of the body e.g., a vein in the pelvis or leg
  • Anti coagulation therapy is the current standard of care for treating pulmonary embolisms, but may not be effective in some patients. Additionally, conventional devices for removing thrombotic material may not be capable of navigating the tortuous vascular anatomy, may not be effective in removing thrombotic material, and/or may lack the ability to provide sensor data or other feedback to the clinician during the thrombectomy procedure.
  • thrombectomy devices operate based on simple aspiration which works sufficiently for certain clots but is largely ineffective for difficult, organized clots.
  • Many patients presenting with deep vein thrombus (DVT) are left untreated as long as the risk of limb ischemia is low. In more urgent cases, they are treated with catheter-directed thrombolysis or lytic therapy to break up a clot over the course of many hours or days.
  • Many thrombectomy devices have elements at the end (e.g. funnels) to assist with capturing clots, but can be difficult to visualize under imaging such as fluoroscopy. This makes it challenging for clinicians to guide the device to a target location and confirm positioning adjacent a clot to be removed.
  • FIGS. 1-1L illustrate various views of a portion of a thrombus removal system including a distal portion of an elongated catheter configured in accordance with an embodiment of the present technology.
  • FIGS. 2A-2E illustrate plan views of various configurations of irrigation ports and fluid streams of a thrombus removal system according to embodiments of the present technology.
  • FIGS. 3A-3H illustrate an elevation view of various configurations of irrigation ports and fluid streams of a thrombus removal system according to embodiments of the present technology.
  • FIGS. 4A-4C illustrate various embodiments of a thrombus removal system including a saline source, an aspiration system, and one or more controls for controlling irrigation and/or aspiration of the system.
  • FIGS. 5A-5B illustrate one embodiment of a funnel of a thrombus removal system that includes imaging markers for visualization under real-time imaging.
  • FIGS. 6A-6B illustrate another embodiment of a funnel of a thrombus removal system that includes imaging markers for visualization under real-time imaging.
  • FIG. 7 illustrates yet another embodiment of a thrombus removal device funnel that includes imaging markers embedded in the funnel.
  • FIGS. 8A-8D illustrate additional embodiments of imaging markers that can be imbedded in a funnel to facilitate real-time monitoring or imaging of the imaging marker and/or funnel location.
  • FIGS. 9A-9D show imaging markers disposed within a funnel of a medical device.
  • FIGS. 10A-10D illustrate imaging markers that are asymmetrical in an axial direction to indicate an orientation of a medical device with respect to an imaging plane.
  • a thrombus removal comprising an elongate shaft comprising a working end, at least one fluid lumen in the elongate shaft, and two or more apertures disposed at or near the working end, the two or more apertures in fluid communication with the least one fluid lumen and configured to generate two or more fluid streams to mechanically fractionate a target thrombus.
  • a medical device comprising an elongate shaft comprising a distal end; and an expandable funnel disposed at or near the distal end, the funnel comprising a compliant material and at least one imaging marker disposed or encapsulated within the compliant material.
  • the device includes a funnel frame disposed within the compliant material.
  • the at least one imaging marker comprises a radiopaque material.
  • the funnel frame comprises a shape memory material.
  • the funnel frame includes a distal end arranged in a chevron pattern.
  • the at least one imaging marker is disposed around at least one segment of the chevron pattern.
  • the at least one imaging marker comprises a circumferential coil disposed near a distal end of the funnel.
  • the at least one imaging marker comprises a plurality of imaging markers embedded in the compliant material at least partially distal to the funnel frame.
  • the at least one imaging marker is arranged generally along a longitudinal axis of the medical device.
  • the at least one imaging marker includes one or more axial flexibility features configured to improve or increase an axial flexibility of the at least one imaging marker.
  • the one or more axial flexibility features comprises a slit or cutout that is orthogonal to a longitudinal axis of the medical device.
  • the one or more imaging markers comprise a serpentine pattern.
  • the serpentine pattern includes gaps between the serpentine pattern than are generally orthogonal to a longitudinal axis of the one or more imaging markers.
  • the serpentine pattern does not include any free ends.
  • the one or more imaging markers are formed from a flat sheet of a
  • the at least one imaging marker is radiopaque.
  • the at least one imaging marker is supported only by a compliant material of the funnel.
  • the at least one imaging marker is supported only by the compliant material.
  • the at least one imaging marker is supported only by the compliant material and not by the frame or rigid structure.
  • the at least one imaging marker comprises platinum iridium.
  • the frame comprises a shape memory material.
  • the at least one imaging marker is arranged generally along a longitudinal axis of the medical device.
  • the serpentine pattern does not include any free ends.
  • the one or more imaging markers are formed from a flat sheet of a Pt-Ir material.
  • a system configured in accordance with an embodiment of the present technology can include, for example, an elongated catheter having a distal portion configured to be positioned within a blood vessel of the patient, a proximal portion configured to be external to the patient, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, and one or more lumens extending at least partially from the proximal portion to the distal portion.
  • thrombus removal Although some embodiments herein are described in terms of thrombus removal, it will be appreciated that the present technology can be used and/or modified to remove other types of emboli that may occlude a blood vessel, such as fat, tissue, or a foreign substance. Additionally, although some embodiments herein are described in the context of thrombus removal from a pulmonary artery (e.g., pulmonary embolectomy), the technology may be applied to removal of thrombi and/or emboli from other portions of the vasculature (e.g., in neurovascular, coronary, or peripheral applications).
  • pulmonary embolectomy e.g., pulmonary embolectomy
  • thrombus thrombus with a fluid
  • present technology can be adapted for use with other techniques for breaking up a thrombus into smaller fragments or particles (e.g., ultrasonic, mechanical, enzymatic, etc.).
  • the present technology is generally directed to thrombus removal systems.
  • Such systems include an elongated catheter having a distal portion positionable within a blood vessel of the patient (e.g., an artery or vein), a proximal portion positionable outside the patient's body, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, and one or more lumens extending at least partially from the proximal portion to the distal portion.
  • a blood vessel of the patient e.g., an artery or vein
  • a proximal portion positionable outside the patient's body
  • a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid
  • an aspiration mechanism configured to aspirate the fragments of the thrombus
  • one or more lumens extending at least partially from the proximal portion to the distal portion.
  • the systems herein are configured to engage a thrombus in a patient's blood vessel, break the thrombus into small fragments, and aspirate the fragments out of the patient's body.
  • the pressurized fluid streams e.g., jets
  • the pressurized fluid streams function to cut or macerate thrombus, before, during, and/or after at least a portion of the thrombus has entered the aspiration lumen or a funnel of the system. Fragmentation helps to prevent clogging of the aspiration lumen and allows the thrombus removal system to macerate large, firm clots that otherwise could not be aspirated.
  • thrombus and “embolism” are used somewhat interchangeably in various respects. It should be appreciated that while the description may refer to removal of “thrombus,” this should be understood to encompass removal of thrombus fragments and other emboli as provided herein.
  • a fluid delivery mechanism can provide a plurality of fluid streams (e.g., jets) to fluid apertures of the thrombus removal system for macerating, cutting, fragmenting, pulverizing and/or urging thrombus to be removed from a proximal portion of the thrombus removal system.
  • the thrombus removal system can include an aspiration lumen extending at least partially from the proximal portion to the distal portion of the thrombus removal system that is adapted for fluid communication with an aspiration pump (e.g., vacuum source).
  • the aspiration pump may generate a volume of lower pressure within the aspiration lumen near the proximal portion of the thrombus removal system, urging aspiration of thrombus from the distal portion.
  • FIG. 1 illustrates a distal portion 10 of a thrombus removal system according to an embodiment of the present technology.
  • FIG. 1 A Section A-A illustrates an elevation sectional view of the distal portion.
  • the example section A-A in FIG. 1 A depicts a funnel 20 that is positioned at the distal end of the distal portion 10, the funnel adapted to engage with thrombus within a blood vessel and/or a tissue (e.g., vessel) wall to aid in thrombus fragmentation and/or removal.
  • the funnel can have a variety of shapes and constructions as would be understood by one of skill from the description herein.
  • the thrombus removal system may be delivered through a sheath to a thrombus site in a blood vessel with funnel 20 in a compressed configuration.
  • Funnel 20 may self-expand as it is advanced out of the sheath and/or as the sheath is retracted from the funnel.
  • the example section A-A in FIG. 1 A depicts a double walled thrombus removal device construction having a catheter 22 extending proximally from funnel 20 with an outer wall/tube 40 and an inner wall/tube 50.
  • An aspiration lumen 55 is formed by the inner wall 50 and is centrally located. Aspiration lumen 55 communicates with a vacuum source, as described below.
  • a generally annular volume forms at least one fluid lumen 45 between the outer wall 40 and the inner wall 50.
  • the fluid lumen 45 is adapted for fluid communication with a fluid delivery mechanism, as described below.
  • One or more apertures (e.g., nozzles, orifices, or ports) 30 are positioned in the thrombus removal system to be in fluid communication with the fluid lumen 45 and an irrigation manifold 25 at the base of funnel 20.
  • the ports 30 are adapted to direct (e.g., pressurized) fluid toward thrombus material that is engaged with the distal portion 10 of the thrombus removal system to macerate, fragment, or cut the thrombus material.
  • Aspiration lumen 55 pulls thrombus material along with fluid from ports 30 and blood from the blood vessel proximally to a receptacle outside of the patient, as described below.
  • the system can have an average flow velocity within the fluid lumen of up to 20 m/s to achieve consistent and successful aspiration of clots.
  • the fluid source itself can be delivered in a pulsed sequence or a preprogrammed sequence that includes some combination of pulsatile flow and constant flow to deliver fluid to the jets.
  • the average pulsed fluid velocity may be up to 20 m/s
  • the peak fluid velocity in the lumen may be up to 30 m/s or more during the pulsing of the fluid source.
  • the jets or apertures are no smaller than 0.0100” or even as small as 0.008” to avoid undesirable spraying of fluid.
  • the system can have a minimum vacuum or aspiration pressure of 15 inHg, to remove target clots after they have been macerated or broken up with the jets described above.
  • the thrombus removal system can be sized and configured to access and remove thrombi in various locations or vessels within a patient’s body. It should be understood that while the dimensions of the system may vary depending on the target location, generally similar features and components described herein may be implemented in the thrombus removal system regardless of the application.
  • a thrombus removal system configured to remove pulmonary embolism (PE) from a patient may have an outer wall/tube with a size of approximately 11-13 Fr, or preferably 12 Fr, and an inner wall/tube with a size of 7-9 Fr, or preferably 8 Fr.
  • PE pulmonary embolism
  • a deep vein thrombosis (DVT) device may have an outer wall/tube with a size of approximately 9-11 Fr, or preferably 10 Fr, and an inner wall/tube with a size of 6-9 Fr, or preferably 7.5 Fr.
  • Applications are further provided for ischemic stroke and peripheral embolism applications.
  • Section B-B of FIG. IB illustrates in plan view a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold.
  • Section B-B depicts an outer wall 140, an inner wall 150, an aspiration lumen 155 and a fluid lumen 145.
  • the aspiration lumen 155 is generally circular and the fluid lumen 145 is generally annular in shape (e.g., cross-section 70). It will be appreciated that alternative constructions and/or arrangements of the inner wall 150 and the outer wall 140 produce variations in cross- sectional shape of the aspiration and fluid lumens 155 and 145.
  • the inner wall 150 can be shaped to form an aspiration lumen 155 that, in cross-section, is generally oval, circular, rectilinear, square, pentagonal, or hexagonal.
  • the inner and outer walls 150 and 140 can be shaped and arranged to form a fluid lumen 145 that, in cross-section, is generally crescentshaped, diamond shaped, or irregularly shaped.
  • the region between the inner wall 150 and the outer wall 140 can include one or more wall structures 165 that form respective fluid lumens 145 (e.g., as in cross-section 80).
  • the wall structures 165 can be formed by lamination between the outer and inner walls 140 and 150, or by a multi-lumen extrusion that forms a plurality of the wall structures.
  • Section B-B of FIGS. 1D-1H illustrate additional examples of a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold. Similar to the embodiments described above, the portion in these examples can include an outer wall 140, an inner wall 150, and an aspiration lumen 155. Additionally, the illustrated portion of the thrombus removal system can include a middle wall 170 disposed between the outer wall 140 and the inner wall 150. The middle wall 170 enables further segmentation of the annular space between the inner wall and outer wall into a plurality of distinct fluid lumens and/or auxiliary lumens. For example, referring to FIG.
  • the middle wall can be generally hexagon shaped, and the annular space can include a plurality of fluid lumens 145a-141 and a plurality of auxiliary lumens 175a-175f.
  • the fluid lumens can be formed by some combination of the outer wall 140 and the middle wall 170, or between the middle wall 170, the inner wall 150, and two of the auxiliary lumens.
  • fluid lumen 145a is formed in the space between outer wall 140 and middle wall 170.
  • fluid lumen 145g is formed in the space between middle wall 170, inner wall 150, auxiliary lumen 175a, and auxiliary lumen 175b.
  • the fluid lumens are configured to carry a flow of fluid such as saline from a saline source of the system to one or more ports/apertures/orifices of the system.
  • the auxiliary lumens can be configured for a number of functions.
  • the auxiliary lumens can be coupled to the fluid/saline source and to the apertures to be used as additional fluid lumens.
  • the auxiliary lumens can be configured as steering ports and can include a guide wire or steering wire within the lumen for steering of the thrombus removal system.
  • the auxiliary lumens can be configured to carry electrical, mechanical, or fluid connections to one or more sensors.
  • the system may include one or more electrical, optical, or fluid based sensors disposed along any length of the system.
  • the sensors can be used during therapy to provide feedback for the system (e.g., sensors can be used to detect clogs to initiate a clog removal protocol, or to determine the proper therapy mode based on sensor feedback such as jet pulse sequences, aspiration sequences, etc.).
  • the auxiliary ports can therefore be used to connect to the sensors, e.g., by electrical connection, optical connection, mechanical/wire connection, and/or fluid connection.
  • the fluid and auxiliary lumens can be configured to carry and deliver other fluids, such as thrombolytics or radio-opaque contrast injections to the target tissue site during treatment.
  • all the fluid lumens are fluidly connected to all of the jets or apertures of the thrombus removal device. Therefore, when a flow of fluid is delivered from the fluid lumen(s) to the jets, all jets are activated with a jet of fluid at once.
  • the fluid lumens are separate or distinct, and these distinct fluid lumens may be fluidly coupled to one or more jets but not to all jets of the device. In these embodiments, a subset of the jets can be controlled by delivering fluid only to the fluid lumens that are coupled to that subset of jets.
  • the fluid pressure is generated at the pump (in the console or handle).
  • the fluid is accelerated as it exits the ports at the distal end and is directed to the target clot. In this way a wider variety of cost-effective components can be used to form the catheter while still maintaining a highly-effective device for clot removal. Additional details are provided below.
  • the embodiment IF includes the same four auxiliary reports as illustrated and described in the embodiment of FIG. IE.
  • Section B-B of FIG. 1G illustrates another example of a portion of the thrombus removal system that is proximal to the funnel and irrigation manifold.
  • the illustrated portion of the thrombus removal system can include a middle wall 170 disposed between the outer wall 140 and the inner wall 150.
  • this embodiment includes four distinct fluid lumens 145a-145d formed by wall structures 165.
  • the wall structures 165 can be formed by lamination between the outer and inner walls 140 and 150, or by a multi-lumen extrusion that forms a plurality of the wall structures.
  • this embodiment can include a pair of auxiliary lumens 175a and 175b, which can be used, for example, for steering or for sensor connections as described above.
  • the inner wall 150 and the outer wall 140 may not be concentric, which facilitates formation of an annular space and/or fluid lumen 145 that is thicker or wider on one side of the device relative to the other side.
  • a distance between the exemplary outer wall 140 and inner wall at the top (e.g., 12 o’clock) portion of the device is larger than a distance between the outer wall and inner wall at the bottom (e.g., 6 o’clock) portion of the device.
  • Section C-C of FIG. IK illustrates in plan view a portion of the thrombus removal system comprising an irrigation manifold 225.
  • Section C-C depicts an outer wall 240, an inner wall 250, a fluid lumen 245, an aspiration lumen 255, and ports 230 for directing respective fluid streams 210.
  • Detail View 101 of FIG. IL illustrates a section view in elevation of a portion of the irrigation manifold 25 at the base of the funnel that includes a plurality of ports 230 that are formed within an inner wall 250.
  • a thickness of one or more walls of the thrombus removal system may be varied along its axial length and/or its circumference.
  • inner wall 250 has a first thickness 265 in a region 250 that is proximal to the irrigation manifold 25, and a second thickness 270 in a region 235 that includes the ports 230.
  • the second thickness 270 is greater than the first thickness 265.
  • Such operating pressure can be from about 10 psi to about 60 psi, from about 60 psi to about 100 psi, or from about 100 psi to about 150 psi.
  • the operating pressure of the fluid delivery mechanism can be any value within the aforementioned range of values.
  • the fluid delivery mechanism is operated in a high pressure mode, having a pressure from about 150 psi to about 250 psi, from about 250 psi to about 350 psi, from about 350 psi to about 425 psi, or from about 425 psi to about 500 psi.
  • the operating pressure of the fluid delivery mechanism in the high pressure mode can be any value within the aforementioned range of values.
  • the manifold is configured to increase a fluid pressure and/or flow rate of the fluid.
  • the manifold When fluid is provided by the fluid delivery mechanism to the fluid lumen(s) at a first pressure and/or a first flow rate, the manifold is configured to increase the pressure of the fluid to a second pressure and/or is configured to increase the flow rate of the fluid to a second flow rate.
  • the second pressure and/or second fluid rate can be higher than the first pressure and/or first flow rate.
  • the manifold can be configured to increase the relatively low operating pressures and/or flow rates generated by the fluid delivery mechanism to the relatively high pressures and/or high flow rates generated by the ports/fluid streams.
  • FIGS. 4A-4C illustrate various configurations of a thrombus removal system 600, including a thrombus removal device, 602, a vacuum source and cannister 604, a fluid source 606, and a pump 607.
  • the vacuum source and cannister and the fluid source are housed in a console unit that is detachably connected to the thrombus removal device.
  • a fluid pump can be housed in the console, or alternatively, in the handle of the device.
  • the console can include one or more CPUs, electronic controllers, or microcontrollers configured to control all functions of the system.
  • the thrombus removal device 602 can include a funnel 608, a flexible shaft 610, a handle 612, and one or more controls 614 and 616.
  • the device can include a finger switch or trigger 614 and a foot pedal or switch 616. These can be used to control aspiration and irrigation, respectively.
  • the device can include only a foot switch 614, which can be used to control both functions, or in FIG. 4C, the device can include only an overpedal 616, also used to control both functions. It is also contemplated that an embodiment could include only a finger switch to control both aspiration and irrigation functions.
  • the vacuum source and cannister 604 can be coupled to the aspiration lumen of the device with a vacuum line 618.
  • any clots or other debris removed from a patient during therapy can be received by, and stored in the vacuum cannister 604.
  • the fluid source 606 e.g., a saline bag
  • the fluid line 620 can be coupled to the fluid lumens of the device with a fluid line 620 for delivery of high-pressure fluid streams or jets at the base of funnel 608 to fragment thrombus material engaged by funnel 608, as described above.
  • pressurized fluid is delivered from fluid source 606 and pump 607 through fluid line 620 and fluid lumen 45 to manifold 25 and ports 30.
  • vacuum is applied to aspiration lumen 55 by vacuum source and cannister 604.
  • the material flowing proximally through aspiration lumen 55 to the vacuum source and cannister is primarily fluid delivered through ports 30 combined with any blood that is able to pass around the engaged thrombus.
  • thrombus material is pulled proximally through aspiration lumen 55 along with the injected fluid and any blood that can pass into the funnel around the thrombus. After the thrombus has been broken up or macerated sufficiently to become dislodged from the blood vessel, the remaining thrombus material moves proximally toward the vacuum source and cannister 604.
  • the thrombus removal devices and systems described herein can include or incorporate features to facilitate real-time imaging and/or tracking of the device during delivery and therapy.
  • the device can include features embedded or integrated into the working end, or more specifically, into the funnel of the device. These features can provide highly visible regions or markers under imaging guidance, such as under fluoroscopy or even ultrasound imaging.
  • a thrombus removal device 10 can include a funnel 20 comprising a funnel frame 22.
  • the funnel frame can provide, for example, a selfexpanding structure configured to allow the funnel to transition from a collapsed delivery configuration to an expanded therapy configuration.
  • the funnel frame can comprise a shape memory material such as nitinol.
  • the funnel frame is covered or embedded within a compliant material, such as a polycarbonate-based thermoplastic urethane (e.g., Chronoflex).
  • the compliant material is not shown in this embodiment for ease of illustration and description.
  • the compliant material can comprise one or more layers.
  • a first layer of compliant material may be placed over an interior portion of the funnel frame and a second layer of the compliant material may be placed of an exterior portion of the funnel frame, to cover and protect the funnel frame from both the interior and exterior sides.
  • the first or interior layer of the compliant material therefore makes up the interior surface of the funnel
  • the second or exterior layer of the compliant material makes up the exterior surface of the funnel. While the compliant material is described as being formed in “layers”, it should be understood that any known technique for placing the compliant material on the funnel frame can be implemented, including spraying on the compliant material, or some combination of spraying, injection molding, or heat treating the compliant material to create the funnel.
  • the thrombus removal device 10 can further include one or more imaging markers 24 in or within the funnel 20.
  • the imaging markers 24 can comprise a radiopaque material.
  • the imaging markers 24 can comprise a platinum-iridium (Pt-Ir) material.
  • the imaging markers 24 comprise a plurality of coiled segments of Pt-Ir.
  • the coiled Pt-Ir segments are wound or coiled around the distal-most segments of the funnel frame 22.
  • the illustrated funnel frame in this embodiment includes a “chevron” pattern on the distal-most portion of the frame, and each segment of the chevron pattern is then covered with the Pt-Ir coils.
  • all, some, or other portions of the funnel frame can be covered with the imaging markers 24.
  • FIG. 5B is a real-time image of the thrombus removal device of FIG. 5 A.
  • the image is a fluoroscopy image of the device and the imaging markers 24 can be clearly seen in the image, including the “chevron” pattern or shape of the markers at the distal end of the funnel.
  • FIGS. 6A-6B illustrate an alternative embodiment of imaging markers disposed on or in the funnel 20 of the thrombus removal device 10.
  • the imaging marker comprises a circumferential ring disposed at or near the distal end of the funnel.
  • the imaging marker(s) of FIG. 6A instead are separate from the frame.
  • the imaging markers are embedded in or supported by the compliant material 26 of the funnel 20.
  • the imaging markers are supported only by the compliant material of the funnel, and do not contact the funnel frame.
  • the imaging marker itself can be similar to the marker of FIGS. 5A-5B and can comprise, for example, a length of Pt-Ir material.
  • the marker can be a wound coil of Pt-Ir. While the embodiment of FIG. 6A shows a circumferential ring, in other embodiments it should be understood that the imaging markers can comprise a plurality of imaging marker segments that form a disjointed pattern around the perimeter of the funnel.
  • the imaging markers can comprise, for example, lines, rectangles, dots, squares, or other shapes that are supported only by the compliant material of the funnel.
  • FIG. 6B shows a real-time image of the thrombus removal device of FIG. 6A.
  • the image is a fluoroscopy image of the device and the circumferential imaging marker 24 can be clearly seen in the image at the distal end of the funnel.
  • FIG. 7 is an additional embodiment of imaging markers 24 disposed on or in the funnel 20 of the thrombus removal device 10.
  • one or more imaging markers 24 are supported only by the compliant material of the funnel.
  • the one or more imaging markers do not contact nor are they supported by the funnel frame 22 of the funnel.
  • the one or more imaging markers 24 may be embedded in the compliant material, which can be a polycarbonate-based thermoplastic urethane (e.g., Chronoflex).
  • the imaging markers can be supported between layers of the compliant material.
  • FIG. 7 includes straight segments of coiled Pt-Ir material extending along a longitudinal axis of the thrombus removal device.
  • the imaging markers are placed in between the peaks 23 of a chevron pattern of the funnel frame 22. As shown, the imaging markers can extend distally beyond the peaks 23 of the funnel frame.
  • the funnel can include six imaging markers placed in this manner.
  • imaging markers can be used, including four, five, six, seven, eight, nine, ten, or more imaging markers.
  • Other locations within the funnel are also contemplated.
  • one or more markers can be placed more proximally in the funnel, towards the aspiration lumen of the device, such as between the funnel frame 22 at location(s) 27.
  • the concept of supporting imaging markers within a compliant material such as Chronoflox is not limited to thrombus removal devices, but can be used in any catheter-based or implantable medical device.
  • catheters that do not include funnels can include imaging markers embedded within or supported only by a compliant material, such as a flexible/atraumatic distal tip, or a compliant coating placed over the catheter shaft.
  • Other devices with rigid frames that may be covered with a compliant material can be used to support imaging markers in a similar manner, such as stents or valve frames. Placing the imaging markers away from a rigid frame provides a clear view of the imaging marker under fluoro and assists the user or medical provider in determining orientation and/or proper placement of the medical device.
  • Arranging the imaging markers in a longitudinal fashion as illustrated in FIG. 7 provides a visual indication to the user regarding the state of the funnel. For example, the user can see if the funnel is in a collapsed configuration or in an open or therapy configuration based on the orientation of the markers. For example, in a collapsed configuration, the imaging markers will generally be close to another and will typically be directed parallel to the longitudinal axis of the thrombus removal device. However, when the funnel is expanded, the distance between the imaging markers will increase. Additionally, some of the markers may not be parallel to the longitudinal axis of the thrombus removal device when the funnel is expanded, but instead will be oriented along with the shape of the expanded funnel.
  • FIGS. 8A-8D illustrate additional embodiments of imaging markers 24 that can be configured to be disposed on or in the funnel 20 of the thrombus removal device described previously.
  • any of the markers of FIGS. 8A-8D can be supported or disposed within a compliant material of the funnel, without contacting or being supported by a rigid or frame element of the funnel.
  • the imaging markers can be formed from flat sheets of Pt-Ir material.
  • compliant material of the funnel can comprise a urethane material such as Chronoflex.
  • the structural components of the funnel, including the funnel frame and any imaging markers can be laminated between two layers of the urethane material (e.g., Chronoflex).
  • the imaging markers are supported only by the compliant material and not by any rigid structures of the device such as a frame (e.g., the funnel frame).
  • the funnel can be configured to be collapsed or constrained during delivery, and can further be configured to be expanded during therapy.
  • the imaging markers of the present disclosure can include features configured to allow the imaging markers to be compliant or flexible in at least the axial or longitudinal direction when embedded in the compliant material of the funnel.
  • FIGS. 8A-8D illustrate axial flexibility features in the imaging markers to allow for flexibility in the axial/longitudinal direction AD when embedded or mounted within the funnel.
  • the cutouts or slits can be arranged to be orthogonal to the axial direction of the imaging markers (and funnel).
  • FIGS. 8 A, 8B, and 8C illustrate imaging markers with axial flexibility features comprising slits or cutouts 26a, 26b, and 26c, respectively, to increase flexibility of the imaging markers in the axial direction.
  • the imaging markers comprise flat sheets of a radiopaque material (e.g., Pt-Ir) with the slits or cutouts removed from the flat sheet (e.g., by laser cutting, etc.).
  • Increasing the number of cutouts or slits can increase the flexibility of the imaging marker in the axial direction. Therefore, the embodiment of FIG. 8 A, with the fewest number of cutouts or slits, is less flexible in the axial direction than the embodiment of FIG. 8B, which is less flexible in the axial direction than the embodiment of FIG. 8C.
  • FIG. 8D provides another imaging marker with increased flexibility in the axial direction.
  • this embodiment is formed in a serpentine pattern so as to provide gaps 26d in the serpentine pattern where the pattern switches back in a direction orthogonal to the axial direction of the imaging marker (and funnel). It should be understood that reducing the thickness of the serpentine pattern and therefore increasing the number of “switchbacks” of the pattern can increase the axial flexibility of the imaging marker, similar to how increasing the number of slits or cutouts in the embodiments of FIGS. 8A-8C increased flexibility in the axial direction.
  • the serpentine pattern can be arranged such that there are no free ends or sharp comers/edges that may poke or puncture through the compliant material of the funnel during compression/expansion. As shown in FIG. 8D, the ends 28 of the serpentine pattern can be tucked or folded back within the serpentine pattern, such that the imaging marker does not terminate in free ends on either axial end of the marker. Similarly, the embodiments of FIGS. 8A-8C also lack free ends or termination points so as to prevent the imaging markers from poking through or puncturing the funnel during compression and expansion.

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Abstract

La présente invention concerne des systèmes et des procédés pour éliminer un thrombus d'un vaisseau sanguin d'un patient. Dans certains modes de réalisation, la présente invention concerne des systèmes comprenant un cathéter allongé ayant une partie distale configurée pour être positionnée à l'intérieur du vaisseau sanguin du patient, une partie proximale configurée pour être externe au patient, et une lumière s'étendant entre les deux. Le système peut également comprendre un mécanisme d'administration de fluide couplé à une lumière de fluide et configuré pour appliquer un fluide afin de fragmenter au moins partiellement le thrombus.
EP23858292.8A 2022-08-24 2023-08-24 Systèmes d'élimination de thrombus et procédés associés Pending EP4577131A1 (fr)

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US202263380851P 2022-10-25 2022-10-25
PCT/US2023/072796 WO2024044671A1 (fr) 2022-08-24 2023-08-24 Systèmes d'élimination de thrombus et procédés associés

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US11389171B2 (en) * 2006-11-21 2022-07-19 David S. Goldsmith Integrated system for the infixion and retrieval of implants
ES2577288B8 (es) * 2015-01-13 2019-01-10 Anaconda Biomed S L Dispositivo para trombectomía
US20170333060A1 (en) * 2016-05-19 2017-11-23 Justin P. Panian Catheter assembly for blood clots removal
US11123135B2 (en) * 2018-05-30 2021-09-21 Biosense Webster (Israel) Ltd. Enhanced large-diameter balloon catheter
US12582425B2 (en) * 2020-12-03 2026-03-24 Covidien Lp Catheter including a radiopaque expandable member

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