US20210128183A1 - Thrombectomy and stenting system - Google Patents

Thrombectomy and stenting system Download PDF

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Publication number
US20210128183A1
US20210128183A1 US16/670,440 US201916670440A US2021128183A1 US 20210128183 A1 US20210128183 A1 US 20210128183A1 US 201916670440 A US201916670440 A US 201916670440A US 2021128183 A1 US2021128183 A1 US 2021128183A1
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Prior art keywords
deployment catheter
stenting
microcatheter
lumen
thrombectomy
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Abandoned
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US16/670,440
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English (en)
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Declan LEE
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Neuravi Ltd
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Neuravi Ltd
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Priority to US16/670,440 priority Critical patent/US20210128183A1/en
Assigned to NEURAVI LIMITED reassignment NEURAVI LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LEE, Declan
Priority to KR1020200123588A priority patent/KR20210053183A/ko
Priority to JP2020169637A priority patent/JP7701003B2/ja
Priority to ES20204898T priority patent/ES3038785T3/es
Priority to CN202011189333.5A priority patent/CN112741669A/zh
Priority to EP20204898.9A priority patent/EP3815634B1/fr
Publication of US20210128183A1 publication Critical patent/US20210128183A1/en
Priority to US18/534,875 priority patent/US12171449B2/en
Abandoned legal-status Critical Current

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Definitions

  • the present invention generally relates devices and methods used in removing obstructions and treating stenosis in the cerebral blood vessels during intravascular medical treatments. More specifically, the present invention relates to a multi-catheter system for bringing together the procedures of mechanical thrombectomy and stenting.
  • Atherosclerosis results from lesions which narrow and reduce the space in the lumen of vessels in the vasculature. Such lesions are usually composed of plaque, which can be fat, cholesterol, calcium, or other components of the blood. Severe occlusion or closure can impede the flow of oxygenated blood to different organs and parts of the body and result in other cardiovascular disorders such as heart attack or stroke. Narrowing of vessels, or stenosis, increases the risk that clots and other emboli can lodge at such locations, especially in the neurovascular where vessel diameters are already small.
  • Intracranial atherosclerotic disease ICAD is the narrowing of those arteries and vessels supplying blood to the brain and represents the most common proximate mechanism of ischemic stroke.
  • Treatment for vascular occlusions are well known in the art. Methods can include utilizing drugs, such as anticoagulants or anti-platelet agents, as well as medical procedures such as surgical endarterectomy, angioplasty, and stenting.
  • drugs such as anticoagulants or anti-platelet agents
  • medical procedures such as surgical endarterectomy, angioplasty, and stenting.
  • ERT endovascular revascularization treatments
  • Devices such as stentrievers, direct-aspiration systems, and other clot retrieval devices have been strongly associated with better clinical outcomes. However, these devices are primarily designed to recanalize the vessel by removing and retrieving an occluding embolus. Sufficient recanalization may not occur if there is also significant stenosis present at the occlusion site, increasing the need for implanted stents.
  • Treatment methods for addressing clots and lesions in the neurovascular in particular depend on the degree of stenosis, the shape of the target occlusion site (i.e. truncal, branching, etc.), and the patient's overall condition.
  • Mechanical procedures often involve using medical devices to retrieve an occlusive clot and then utilizing balloons and stents to open a narrowed artery.
  • a balloon is delivered to a target site and inflated to dilate the stenosis. The balloon can then be removed and exchanged through a catheter for a stent delivery device. If desirable, once the stent is in place a balloon can be inflated inside the stent to press the struts of the stent frame firmly against the inner wall of the vessel.
  • the presence of the stenosis is only identified after initial treatment options are chosen and an ERT procedure is already underway, and the devices and methods used to remove occlusions are often different from those used to treat stenosis and stent a vessel.
  • the need for shorter door-to-procedure times in is always present to limit lasting damage in ischemic stroke patients. Therefore, there remains a need for new systems and devices to continue to address and improve these treatments.
  • the present design is aimed at providing an improved system and method for treating the combined presence of clots and stenosis in the cerebral vasculature which addresses the above-stated deficiencies.
  • the proposed system provides for a three-catheter setup.
  • the first catheter has the largest diameter and can serve as a guide catheter while also being a deployment sheath for the other catheters.
  • the second catheter can be configured for aspiration and can include a stepped or recessed section proximal of the distal tip that can serve as a housing for a braided expandable stent.
  • the outer diameter of this stepped section can be lined with a balloon or other inflatable member on top of which the flexible stent sits.
  • a microcatheter Internal to the second catheter is a microcatheter which can deliver mechanical thrombectomy devices to the target site to retrieve an occlusion in the vessel.
  • An example system for removing a clot from and stenting a blood vessel can include a sheath member, a deployment catheter, and a microcatheter.
  • the three catheters can be substantially concentric.
  • a source can be configured to aspirate the internal lumen of the sheath member and/or deployment catheter.
  • the deployment catheter can have a lumen and an outer surface and be disposed within the lumen of the sheath member.
  • the deployment catheter can have a flexible distal portion and a recessed region on its outer surface with an outer diameter less than the outer diameter of the deployment catheter in a region adjacent to the recessed region.
  • the flexible region can enhance deliverability and encompass the distalmost region of the deployment catheter. For example, the flexible region could extend 15-30 centimeters proximal of the distal tip.
  • An inflation device and a stenting device can circumscribe the recessed region of the deployment catheter outer surface.
  • the recessed region can provide a seat for the inflation and stenting devices on the outer surface and provide for a more low-profile system.
  • the stenting device could be self-expandable, or the inflation device can be used to expand the stenting device in a stenotic lesion and implant it as a stent, similar to traditional methods for balloon angioplasty known in the art. Inflation could be accomplished by utilizing an inflation lumen which could run the length of the deployment catheter.
  • the inflation device could also be used to dilate the vessel during any part of the stenting procedure.
  • the system can be used as an aspiration catheter utilizing suction to remove an occlusive clot.
  • the system can retrieve the clot by aspirating the clot in to the lumen of the deployment catheter, or by utilizing other mechanical thrombectomy procedures.
  • the third catheter of the system can be a microcatheter situated in the lumen of the deployment catheter and configured to deliver a mechanical thrombectomy device to a target occlusion.
  • the mechanical thrombectomy device can be any of a number of commercially-available designs.
  • an expandable clot retriever which has a collapsed configuration inside the microcatheter but self-expands into an enlarged deployed configuration upon exiting the lumen at the distal tip.
  • the clot engaging portion of the device can have expandable members which can create a flow lumen across an occlusion when deployed, while also having a plurality of struts which imbed to provide a strong grip on the clot for the initial step of disengaging the clot from the vessel.
  • the device could be retracted proximally into the deployment catheter with aspiration. The device and clot can then either be withdrawn from the patient through the lumen of the catheter or can be drawn back far enough to lodge a firmer clot in the tip of a larger catheter to be withdrawn in tandem with the catheter.
  • a thrombectomy and stenting system for removing a clot from a blood vessel and stenting the blood vessel can include a sheath member, a deployment catheter situated in the lumen of the sheath member, and a microcatheter situated in the lumen of the deployment catheter.
  • the sheath member, deployment catheter, and microcatheter can be concentric with one another and configured to move independently along a longitudinal axis of the system.
  • An expandable stenting device can be coupled to an outer surface of the deployment catheter.
  • the microcatheter can contain a clot retrieval device for capturing and removing the clot from the vessel.
  • the body of the stenting device can have a braided or interlinking pattern with a matrix of sufficient density to support the walls of the vessel when implanted.
  • the mesh tube of the stent can be of medical-grade stainless steel, such as 316 SS, or a cobalt or cobalt-chrome alloy. In other examples, the stent can be of polymeric or partial-polymeric construction.
  • the mesh braid could also be made from a shape-memory allow such that it self-expands upon deployment.
  • the stent can be bare metal, or the material can be coated with a non-pharmacological coating such as silicon carbide, carbon, and titanium-nitride-oxide. In other cases, stents have been coated with biodegradable, drug-eluting coatings designed to inhibit restenosis. These coatings could be anti-platelet or anti-coagulative agents to help prevent clot formation after the procedure.
  • a portion of the deployment catheter outer surface can contain a depressed region having a dimension that is less than a dimension of another region of the deployment catheter adjacent to the depressed region.
  • the depressed region can be formed integrally with the body of the deployment catheter, such as a notch or groove cut in to the outer surface of the deployment catheter.
  • the depressed region could be laser cut into the outer surface. Further features could also be cut in to the surface to improve flexibility and trackability of the catheter.
  • the expandable stenting member can be sized so that the member is situated on or housed in the depressed region.
  • the system can also have an inflation device which is circumscribed with the stenting device on the outer surface of the deployment catheter.
  • the sheath member When the user wishes to implant a stent in a region of stenosis, the sheath member can be withdrawn to expose the stenting device.
  • the inflation device can then be inflated to expand the stenting device scaffolding and exert a radial force on the walls of the vessel.
  • a patient's vasculature is accessed using conventionally-known techniques.
  • a sheath member is positioned approximate a stenotic lesion and occlusive clot.
  • a deployment catheter is disposed within the lumen of the sheath member.
  • a microcatheter containing a thrombectomy device is positioned in the lumen of the deployment catheter.
  • a stenting device comprising an inflation device and a stent is positioned on an outer surface of the deployment catheter approximate the distal end of the catheter.
  • An aspiration source such as a vacuum pump or syringe, is configured to direct aspiration through the lumen flow path of one or both of the sheath member and deployment catheter. Aspiration can be utilized both for clot retrieval and for preventing additional embolization.
  • the microcatheter and thrombectomy device are extended towards and across the occlusive lot while maintaining the sheath, deployment catheter, and the stenting device approximate the lesion.
  • the clot can be aspirated through the lumen of the deployment catheter.
  • the clot is captured by deploying the thrombectomy device from the microcatheter by maintaining the position of the thrombectomy device across the clot and retracting the microcatheter proximally.
  • the microcatheter and thrombectomy device with the captured clot can then be withdrawn into the lumen of the deployment catheter.
  • the sheath member, deployment catheter, and stenting device can be advanced over the thrombectomy device to cross and align with the stenosis. Once in position, the sheath member can be retracted proximal of the lesion to expose the stenting device.
  • the inflation device of the stenting device can be inflated, radially expanding both the inflation device and stent across the lesion.
  • This radial expansion can increase the diameter of a first portion of the vascular comprising the lesion to at least 75% of the diameter of a second portion of the vascular adjacent to the first portion.
  • This process opens the vessel and reduces the narrowing/occlusion caused by the stenosis.
  • the stent can be released in place as an implant by deflating the inflation device. Once the stent is in place, the remainder of the system can be withdrawn from the patient.
  • FIGS. 1A-1C are views of the three-catheter system according to aspects of the present invention.
  • FIG. 2 shows the system at a target location in the neurovascular with a stenotic lesion and an occlusive clot according to aspects of the present invention
  • FIGS. 3A-3J show cross sections which illustrate the steps of using the system to perform a mechanical thrombectomy and stenting procedure according to aspects of the present invention
  • FIG. 3A illustrates the system at the target site and the microcatheter advanced across the occlusive clot according to aspects of the present invention
  • FIG. 3B illustrates the thrombectomy device of the system deployed to capture an occlusive clot according to aspects of the present invention
  • FIG. 3C shows the thrombectomy device and captured clot being withdrawn back inside the system according to aspects of the present invention
  • FIG. 3D shows the remainder of the system being advanced to a position where the stenting device is aligned with the lesion according to aspects of the present invention
  • FIG. 3E illustrates the outer sheath member being retracted to expose the stenting device according to aspects of the present invention
  • FIG. 3F shows the inflation of the inflation device radially expanding the stenting device to widen the narrowed vessel according to aspects of the present invention
  • FIG. 3G shows the continued inflation of the inflation device to widen the vessel according to aspects of the present invention
  • FIG. 3H shows the full desired inflation of the inflation device and the stent embedded in the vessel according to aspects of the present invention
  • FIG. 3I shows the deflation of the inflation device to release the stent in place according to aspects of the present invention
  • FIG. 3J shows the withdrawal of the remainder of the system leaving the stent implanted according to aspects of the present invention
  • FIG. 4 is a flow diagram outlining a method for using the system to conduct mechanical thrombectomy and stenting operations according to aspects of the present invention.
  • FIGS. 1A-1C illustrate a system 100 capable of treating both occlusions and stenosis in a blood vessel.
  • the system 100 can have a first outer guide catheter or sheath member 102 having an internal lumen 104 .
  • a second deployment catheter 106 can be disposed in the lumen 104 of the sheath member 102 .
  • the sheath member 102 can act as a guide catheter for the system 100 .
  • the sheath member can also serve as a deployment sleeve for the deployment catheter, protecting the rest of the system during delivery and deployment.
  • the deployment catheter 106 can have a distal end 107 , an outer diameter D 2 , an outer surface 110 , an inner lumen 108 , and a flexible portion 111 disposed circumferentially in an annular pattern around the outer surface approximate the distal end.
  • the deployment catheter can also have a stepped or depressed region 120 just proximal of the distal end 107 of the catheter where the depressed region outer diameter D 1 is less than the nominal deployment catheter outer diameter D 2 .
  • the depressed region 120 thus can represent a recess or groove-like feature of the deployment catheter.
  • the depressed region can take on a trapezoidal shape with shallow corners or could assume a number of other shapes, such as a half ellipse, so long as it is at least partially recessed from the outer surface of the deployment catheter 106 and rings at least a portion of the circumference.
  • An expandable stenting device 112 can be disposed concentrically to circumscribe the outer circumference of an uninflated inflation device 122 and approximate to the flexible portion 111 of the deployment catheter 106 .
  • the stenting device can be disposed within the flexible portion of the deployment catheter.
  • the flexible portion 111 extends proximally from the distal end 107 of the deployment catheter 106 for a length of approximately 20 cm.
  • the expandable stenting device 112 can be a stent having a plurality of resilient metal or plastic strands formed in a braided pattern.
  • the stenting device can be self-expanding when deployed from the system or could be expanded with the aid of the inflation device 122 .
  • this braid of the implantable stent of the stenting device can be of any of a number of stainless-steel alloys, or of a cobalt or cobalt-chrome alloy construction.
  • the stent braid can be made of polymeric strands.
  • the braid of the stenting device 112 can be manufactured from Nitinol or a similar superelastic alloy having the shape-memory properties of a tubular structure with a predetermined outer diameter.
  • a self-expanding stenting device could be actuated by retracting the outer sheath member 102 and might not require a separate inflation device 122 for deployment, but a balloon could still be used for pre- or post-dilation of the vessel during the implantation process.
  • This tubular structure can be heat treated on a mandrel to a suitable temperature to anneal the structure, causing the tube to conform to the shape of the mandrel.
  • the elastic properties of the stent braid could be controlled such that the stent can self-expand to aid in the implantation process.
  • the properties are also important so the stent can maintain stiffness and strength over the desired lifetime of the implant.
  • the winding of the braid strands can also be sufficiently dense to provide a stable configuration capable of supporting the full inner circumference of a vessel when implanted.
  • the strands or struts of the stent can extend longitudinally and be woven in a largely helical configuration with the central axis or centerline 130 of the resulting tubular structure as a common axis.
  • a first set of strands can be wound in one direction while being axially displaced from one another.
  • a second group of strands could be wound in the opposite direction from the first while also being axially displaced relative to each other.
  • the stenting device can also be bare metal or could be coated in a number of ways.
  • the coating can be hydrophilic or have additives effective to increase the lubricity of the mesh braid of the stenting device 112 to allow for more atraumatic navigation of the vasculature.
  • the coating could be hydrogel or include soluble particles in a polymeric matrix which could soften or fully dissolve when exposed to an aqueous medium like blood.
  • the coating could have embedded pharmaceutical agents, such as anti-platelet, anti-coagulant, anti-inflammatory, or anti-microbial agents. These agents could elute from the matrix of the coating when exposed to aqueous media and help prevent the implanted stent from forming a potential nidus for future clot formation.
  • the inflation device 122 can be coupled, glued, or welded to the outer surface 110 of the deployment catheter.
  • the inflation device 122 can have one or more balloon or innertube-type members of varied construction and an expanded condition configured to expand and implant the stenting device 112 .
  • Inflation of the inflation device can be accomplished through an inflation lumen or tube 124 running the length of the deployment catheter 106 .
  • the inflation tube can occasionally be an independent member, but more often can be a hollow lumen incorporated into the internal construction of the deployment catheter.
  • the expandable stenting device and inflation device can together circumscribe the depressed region 120 of the deployment catheter 106 and together the assembly could have a nominal radial dimension similar to the nominal outer diameter D 2 of the deployment catheter.
  • the depressed region 120 within the flexible distal section 111 of the deployment catheter 106 can be a housing for the inflation device 122 and stenting device 112 during delivery of the system 100 .
  • the longitudinal length of depressed region 120 could be such that the region could accommodate the most common neurovascular stent sizes.
  • the balloon can be constructed of any of a number of materials, such as Chronoprene, Polyurethane, Nylon, PBx, or another thermoplastic elastomer. These materials allow the balloon to be durable and thin.
  • the final shape of the balloon or balloons could be varied and tailored to the shape of the stenting device 112 . In one instance, the balloon could have a substantially tubular profile with conical ends.
  • tubular and generally illustrated as a substantially right cylindrical structure
  • tubular and tube are to be construed broadly. They are not meant to be limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length.
  • a microcatheter 114 which can be disposed within the lumen 108 of the deployment catheter 106 .
  • the microcatheter can be concentric with both the guide/sheath member 102 and deployment catheter 106 about the central longitudinal axis 130 of the system 100 .
  • the sheath member, deployment catheter, and microcatheter can be independently moveable with respect to one another.
  • the deployment catheter can be used to first aspirate an occlusive clot 50 , after which if necessary, the microcatheter can be used for the delivery and deployment of a mechanical thrombectomy device 118 .
  • the mechanical thrombectomy device can be any of a number of commercially available products.
  • the device can have a clot retriever with a clot engaging portion having a collapsed delivery configuration within the microcatheter and be self-expanding to an expanded deployed configuration once emerged from the distal tip 115 of the microcatheter.
  • the engaging portion can have an expandable network of struts for gripping the clot and dislodging it from the vessel.
  • the shape of the network can be designed such that when the device 118 is retracted, the struts exert a force on the clot in a direction substantially parallel to the direction in which the clot 50 is being pulled from the vessel (i.e. substantially parallel to the longitudinal axis 130 of the system).
  • This atraumatic function is important for the often-fragile vessels of the neurovascular 40 .
  • microcatheter 114 and thrombectomy device 118 deploy and retract from within the lumen 108 of the deployment catheter 106 so clot retrieval process can be kept isolated from and not interfere with the stenting process. Similarly, a thrombus could be aspirated and retrieved through the inner lumen of the deployment catheter without the use of the thrombectomy device.
  • Aspiration can be directed through the lumen 104 of the sheath member 102 , deployment catheter 106 , or both.
  • a seal could be formed between the inner and outer surfaces of the catheters.
  • suction could be directed to the mouth at the distal end 107 of the deployment catheter 106 by utilizing a seal of hydrogel between the outer surface 110 of the deployment catheter and the inner wall of the sheath member.
  • an expandable member or frame could be used as a flow restriction between the surfaces.
  • the low-pressure region could thereby be transferred to the distal end 107 of the deployment catheter 106 .
  • a thrombectomy and stenting system 100 for removing a clot from and stenting a neurovascular 40 blood vessel can include a sheath member 102 , a deployment catheter 106 disposed in a lumen 104 of the sheath member, a microcatheter 114 oriented in a lumen 108 of the deployment catheter, and a thrombectomy device 118 arranged in a lumen 116 of the microcatheter.
  • the sheath member 102 , deployment catheter 106 , and microcatheter 114 can be substantially concentric and configured to move independently of each other along a longitudinal axis A 1 .
  • Aspiration for supported procedures can be directed to the mouth at the distal end 107 of the deployment catheter.
  • the thrombectomy device can have an expandable framework of struts or crowns configured to grip and remove an occlusive clot 50 .
  • the outer surface 110 of the deployment catheter 106 can also have a depressed region 120 .
  • the depressed region can have a first radial dimension D 1 less than a second radial dimension D 2 of another region of the outer surface adjacent to the depressed region.
  • the deployment catheter 106 can have an expandable stenting device 112 coupled to the deployment catheter outer surface 110 .
  • the stenting device can circumscribe the depressed region 120 , such that it is substantially radially flush with the outer surface 110 .
  • An inflation device 122 configured to expand the stenting device 112 can also be included and coupled to the outer surface of the deployment catheter.
  • the inflation device is a circumferential balloon that could be inflated by a contrast liquid media. At least a portion of the stenting device 112 can circumscribe the inflation device 122 .
  • FIG. 2 shows the composite system 100 navigated through the internal Carotid artery 30 to a target site within the neurovascular 40 .
  • the target site can be a vessel occluded as shown, with an obstructive clot lodged in an area of intercranial stenosis in the form of a lesion 60 caused by the buildup of atherosclerotic plaque.
  • An advantage offered by the system as seen in FIG. 2 is that the guide catheter or sheath member 102 of the system can act as a sleeve capable of protecting internal components of the system during navigation to the site.
  • FIGS. 3A-3J show cross sections which illustrate example steps of one way of using a system of the invention to perform a mechanical thrombectomy and subsequent stenting procedure.
  • the deployment catheter 106 can be used as an aspiration catheter to aspirate the occlusion into the lumen 108 of the deployment catheter for removal.
  • the microcatheter 114 can be advanced beyond the distal end 107 of the deployment catheter 106 and across the clot until the distal end 115 is distal of the clot, as shown in FIG. 3A .
  • a guidewire could also be used for positioning the microcatheter.
  • radiopaque markers or coils can also be added to various portions of the device and/or catheter to aid the user in determining when the device is appropriately positioned across the clot.
  • a coil of radiopaque material such as tungsten and/or platinum, can be attached to the distal end of the thrombectomy device so that the terminal end can be visualized readily during the treatment procedure.
  • the thrombectomy device 118 can be unsheathed as the microcatheter 114 is withdrawn proximally, allowing the thrombectomy device to expand within and to either side of the clot 50 , as shown in FIG. 3B .
  • the scaffold of the capture portion of the device expands to grip portions of the clot.
  • the device can be withdrawn proximally back in to the deployment catheter 106 , as shown in FIG. 3C . This could be done with the aid of aspiration through the deployment catheter 106 to help sustain a firm grip on the clot and avoid fragment loss and migration. If desired, the user can completely remove the thrombectomy device and microcatheter from the system 100 and patient to allow for more efficient aspiration during subsequent steps. Multiple passes with the microcatheter and thrombectomy device may also be necessary to sufficiently clear the vessel.
  • the remainder of the system 100 within the sheath member 102 can be advanced across the stenosis, such that the stenting device 112 and inflation device 122 are aligned with the lesion 60 , as seen in FIG. 3D .
  • Good alignment can ensure that the radial force exerted on the vessel when they stenting device is expanded is distributed as uniformly as possible along the longitudinal length of the device.
  • proper alignment can be achieved with the placement of radiopaque markers or coatings.
  • the sheath member 102 can be retracted so that the sheath distal end 109 returns proximal to the stenosis to expose the stenting device 112 , as seen in FIG. 3E .
  • the stenting device can 112 can self-expand of be radially expanded by the inflation device 122 .
  • the inflatable members of the inflation device 122 can be filled with a working fluid, typically a contrast medium, via the inflation lumen or tube 124 .
  • the inflation device can radially expand the stenting device 112 as illustrated in FIG. 3F .
  • the outer surface of the stenting device can first contact the plaque or fatty deposits of the lesion 60 .
  • 3G shows that as the outer diameter of the stenting device continues to grow, this contact can gently exert a compressive radial force on the lesion by squeezing it between the stenting device and vessel wall. Once the lesion can no longer be further compressed, continued inflation can dilate and enlarge the luminal diameter until a desired implant diameter D 3 of the vessel is reached, as demonstrated in FIG. 3H . In one example, this desired diameter is reached when a constricted first diameter in portion of the vessel containing the lesion increases to 75% of a second diameter in a portion of the vessel adjacent to the first.
  • the stenting device 112 can be a self-expanding structure configured to assume a predetermined outer diameter when deployed without the need for an inflation device 122 .
  • the outer diameter for the device can be chosen such that a desired radial force is applied to the vessel and an implant diameter D 3 sufficient to recanalize flow.
  • the stenting device 112 can be left in place as an implanted stent by deflating the inflation device 122 . This could be accomplished by attaching an aspiration source to the proximal end of the inflation tube 126 . Aspiration could continue until the inflation device had shrunk to a diameter approximate the diameter D 2 of the outer surface 110 of the deployment catheter 106 . Alternatively, aspiration could continue until the inflation device had shrunk to a diameter less than the inside diameter of the sheath member 102 , allowing the deployment catheter to be retracted into the lumen 104 of the sheath member 102 , as shown in FIG. 3I and FIG. 3J . No longer pinned by the inflation device, the expanded stenting device 112 remains in place as a stent to ensure the patency of the target vessel lumen.
  • FIG. 4 is a flow diagram including method steps for administering an intravascular treatment involving thrombectomy and stenting using a system such as the examples described herein.
  • access to a patient's vascular is gained through traditionally-known techniques and a three-catheter system is positioned approximate a lesion and occlusive clot in an occluded vessel in the neurovascular.
  • the first catheter can be a guide catheter or sheath member as described herein or as would otherwise be known to a person of ordinary skill in the art.
  • the second catheter can be a delivery catheter with an inflation device and a stenting device as described herein.
  • the delivery catheter can further be configured as an aspiration catheter.
  • the third catheter can be a microcatheter with a lumen and a thrombectomy device therein as described herein or as would otherwise be known to a person of ordinary skill in the art.
  • a distal portion of the microcatheter and the thrombectomy device is advanced from the deployment catheter towards and across an occlusive clot in a neurovascular vessel while maintaining the deployment catheter, inflation device, stenting device, and sheath approximate the lesion.
  • the thrombectomy device is deployed to capture the occlusive clot as illustrated and described herein or by other means, such as direct aspiration, as would be understood by a person of ordinary skill in the art.
  • Step 430 can also include the step of retracting the captured clot, thrombectomy device, and microcatheter proximally back in to the lumen of the deployment catheter. The captured clot, thrombectomy device, and microcatheter can be completely removed from the system and patient if desired by the user at this stage.
  • step 440 the sheath member, deployment catheter, inflation device, and stenting device are advanced distally across the lesion.
  • the stenting device can be aligned with the lesion.
  • step 450 the sheath member is retracted proximal to the lesion to expose and allow for expansion of the stenting device.
  • the inflation device is inflated to expand the stenting device to dilate the lesion and increase the diameter of the vessel lumen.
  • the stenting device can be expanded until a desired stent implant diameter is reached.
  • the inflation device is deflated to release pressure on the implanted stenting device and allow the deployment catheter to be withdrawn in to the sheath member.
  • the stent is left in the vessel as an implant. Step 480 can further have the step of removing the rest of the system from the patient.
  • distal and proximal are used throughout the preceding description and are meant to refer to a positions and directions relative to a treating physician. As such, “distal” or distally” refer to a position distant to or a direction away from the physician. Similarly, “proximal” or “proximally” refer to a position near to or a direction towards the physician. Furthermore, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
  • the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ⁇ 20% of the recited value, e.g. “about 90%” may refer to the range of values from 71% to 99%.

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US16/670,440 US20210128183A1 (en) 2019-10-31 2019-10-31 Thrombectomy and stenting system
KR1020200123588A KR20210053183A (ko) 2019-10-31 2020-09-24 혈전제거 및 스텐팅 시스템
JP2020169637A JP7701003B2 (ja) 2019-10-31 2020-10-07 血栓除去及びステント留置システム
ES20204898T ES3038785T3 (en) 2019-10-31 2020-10-30 Thrombectomy and stenting system
CN202011189333.5A CN112741669A (zh) 2019-10-31 2020-10-30 血栓切除和支架植入系统
EP20204898.9A EP3815634B1 (fr) 2019-10-31 2020-10-30 Thrombectomie et système de pose d'endoprothèse
US18/534,875 US12171449B2 (en) 2019-10-31 2023-12-11 Thrombectomy and stenting system

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US12171449B2 (en) 2024-12-24
ES3038785T3 (en) 2025-10-15
EP3815634B1 (fr) 2025-07-23
US20240108370A1 (en) 2024-04-04
EP3815634A1 (fr) 2021-05-05
JP2021069933A (ja) 2021-05-06

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