Patent Application
20250160867
This disclosure relates to thrombectomy devices and methods to treat chronic occlusive deep vein thrombosis.
The vascular system carries blood throughout the body. The vascular system includes arteries that distribute blood containing oxygen from the heart throughout the body and veins that carry deoxygenated blood back to the heart.
Thrombosis occurs when a thrombus (e.g., blood clot) forms within a blood vessel, whether venous or arterial. The thrombus may restrict blood flow through the blood vessel. For example, deep vein thrombosis (DVT) occurs when the thrombus forms in a deep vein, restricting blood flow back toward the heart. DVT typically develops in the lower leg, thigh, or pelvis but may also occur in other locations of the body, such as the arm. DVT can result in swelling, pain, discoloration, scaling, and/or ulcers. Additionally, a fragment (e.g., embolus) of the thrombus may break off and travel through the blood stream to the lungs, resulting in a pulmonary embolism (PE)—a potentially fatal condition.
Thrombi can be removed by way of a thrombectomy procedure. A thrombectomy procedure may include navigating a guide wire with the assistance of an imaging system (e.g., fluoroscopic x-ray imaging) through the vascular system to pass through the thrombus to a distal location. A catheter can be advanced along the guide wire and through the thrombus to deploy (e.g., expand) an expandable bag distal of the thrombus. The expandable bag can be retracted proximally, scraping the inner walls of the vessel, to capture the thrombus and deposit it into the catheter for removal.
A thrombus can include fibrin, red blood cells, platelets, leukocytes, and neutrophil extracellular traps. As time passes, the thrombus can become chronic, accumulating more collagen and fibrin content. As more collagen is accumulated, the chronic thrombus can become harder, which can make it more difficult to remove. For example, the chronic thrombus can be firmly attached to the vein wall. The chronic thrombus can be hard such that it can be difficult to core the chronic thrombus. For example, a proximally retracting bag can have difficulty passing through (e.g., cutting) the chronic thrombus to core (e.g., remove a middle portion) the thrombus.
Disclosed herein are thrombectomy devices that can, in some variants, address one or more of the problems discussed above. The thrombectomy devices can include a collection device, a cutting device, and and/or an expansion device. The cutting device can be coupled to a proximal portion of the collection device. A proximal portion of the cutting device can include one or more cutting features to cut a thrombus. The one or more cutting features can include an annular arrangement, which can provide a cutting diameter. The expansion device can be coupled to a proximal portion of the cutting device. The expansion device can collapse and expand the cutting device which, in some variants, can collapse and expand the collection device coupled to the cutting device. The expansion device can enable a user (e.g., clinician) to precisely adjust the cutting diameter provided by the one or more cutting features. The expansion device can maintain the one or more cutting features in a fixed arrangement during proximal retraction into a thrombus for cutting, which can help to prevent the cutting device from collapsing when cutting. For example, the expansion device can provide a high hoop stress and/or compression force across the cutting diameter to help prevent the cutting diameter provided by the cutting device from collapsing when encountering occlusive thrombus (e.g., chronic thrombus). In some variants, all or portions of the collection device, cutting device, and/or expansion device can be energized (e.g., heated and/or electrified) ease cutting through the thrombus, which can reduce the force required to cut through a thrombus and/or improve efficacy. In some variants, the thrombectomy device can include a conductor (e.g., wire) that can be heated, which can include heating with electrical energy (e.g., direct current, alternating current). In some variants, the conductor can be resistively heated with electricity. In some variants, the conductor can be coupled and/or otherwise disposed proximate any portion of the collection device, cutting device, and/or expansion device. The heated conductor can ease cutting a thrombus with heat. In some variants, the structure of the conductor itself can cut the thrombus. The conductor can form a loop which includes a portion carrying electrical energy distally and another portion carrying electrically energy proximally. In some variants, the one or more cutting features of the cutting device can be energized to ease cutting through the thrombus.
In use, a clinician can percutaneously access the vasculature of a patient. The clinician can navigate a guide wire through the vasculature to a thrombus, which can include using an imaging system (e.g., fluoroscopic x-ray imaging) to navigate. The guide wire can be distally advanced to penetrate and pass through the thrombus to position a distal end of the guide wire distal of the thrombus. In some variants, the guide wire can be energized with heat to ease penetration. A collapsed thrombectomy device, which can include being disposed within a tube such as a sheath, can be advanced distally over the guide wire to pass through and distal of the thrombus. With the collapsed thrombectomy device distal of the thrombus, the tube covering the collapsed thrombectomy device can be proximally retracted to uncover the collapsed thrombectomy device. The expansion device can be operated to expand the cutting device and/or the collection device. The expansion device can be operated to precisely adjust and maintain the cutting device at a desired cutting diameter (e.g., position the one or more cutting features of the cutting device in an arrangement for a desired cutting diameter), which can include expanding the cutting device to engage the vein wall or be offset radially inward of the vein wall. With the cutting device and/or collection device expanded, the thrombectomy device can be proximally retracted to engage the cutting features of the cutting device with the thrombus. The one or more cutting features can separate (e.g., cut) a portion (e.g., core) of the thrombus from the thrombus or substantially all of the thrombus from the vein wall. With the proximal retraction of the thrombectomy device, the separated portion of the thrombus or thrombus can pass through an interior of the cutting device and into an interior of the collection bag. With the cutting features of the cutting device proximal of the thrombus location, the expansion device can be operated to collapse the cutting device and collection device, which can trap the separated portion of thrombus or thrombus. The collapsed thrombus device can be proximally retracted out of the patient with the separated portion of the thrombus or thrombus. As described herein, in some variants, the thrombectomy device, can include a conductor that can be heated prior to and/or while retracting the one or more cutting features into the thrombus to ease cutting. Once through the thrombus, the conductor can stop being heated. In some variants, coring the thrombus can enable the vein to be more aptly treated with a stent.
In some aspects, the techniques described herein relate to a thrombectomy device configured to remove a thrombus from a vein, the thrombectomy device including: a plurality of shafts including an inner shaft, an inner expander shaft, and an outer expander shaft; a collection device including a basket with a closed distal end coupled to the inner shaft and an open proximal end; a cutting device including a frame, the frame including: an open distal end coupled to the open proximal end of the collection device; an open proximal end; an interior lumen spanning between the open proximal end and the open distal end of the frame; and one or more cutting elements disposed at the open proximal end; an expansion mechanism including a distal portion, a proximal portion, and a plurality of members spanning between the proximal portion and the distal portion, the distal portion coupled to the inner expander shaft, the proximal portion coupled to the outer expander shaft, and the plurality of members coupled to the one or more cutting elements; wherein the expansion mechanism is configured to expand the open proximal end of the cutting device with the proximal portion and distal portion moved toward each other such that the plurality of members move radially outward with the one or more cutting elements; and wherein the expansion mechanism is configured to collapse the open proximal end of the cutting device with the proximal portion and the distal portion moved away from each other such that the plurality of members move radially inward with the one or more cutting elements.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the inner expander shaft is configured to be distally advanced relative to the outer expander shaft to collapse the expansion device.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the inner expander shaft is configured to be proximally retracted relative to the outer expander shaft to expand the expansion device.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the one or more cutting elements include proximally-pointed cutting points.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the frame of the cutting device includes a plurality of struts coupled together to form diamond-shaped cells.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the collection device includes a distal tip that is tapered.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the one or more cutting elements includes four cutting elements.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the one or more cutting elements includes only four cutting elements.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a conductor configured to be heated, the conductor disposed proximate the one or more cutting elements to ease cutting the thrombus.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the conductor is configured to be disposed at a periphery of the open proximal end of the frame of the cutting device.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the conductor is heated with electrical energy.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the outer expander shaft includes a handle and the inner expander shaft includes a handle.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a threaded connection between the handle of the inner expander shaft and the handle of the outer expander shaft, wherein rotation of the handle of the inner expander shaft is configured to distally advance or proximally retract the inner expander shaft relative to the outer expander shaft.
In some aspects, the techniques described herein relate to a thrombectomy device including a collection device with a mesh structure having a closed distal end and an open proximal end; a cutting device including a frame, the frame including: an open distal end coupled to the open proximal end of the collection device; an open proximal end; an interior passage spanning between the open proximal end and the open distal end of the frame; and one or more cutting elements disposed at the open proximal end; an expander coupled to the open proximal end, the expander configured to expand and collapse to expand and collapse the open proximal end of the cutting device, wherein the expander is configured to enable a clinician to adjust and maintain a cutting diameter of the one or more cutting elements.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the expander is configured to enable the clinician to adjust the diameter of the cutting diameter along a continuum of diameters.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the expander includes a balloon that is configured to be inflated to expand the open proximal end of the cutting device and to be deflated to collapse the open proximal end of the cutting device.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a conductor configured to be disposed proximate the one or more cutting elements, the conductor configured to be heated to facilitate cutting the thrombus.
In some aspects, the techniques described herein relate to a thrombectomy device, further including an inner expander shaft and an outer expander shaft, wherein the expander is coupled to the inner expander shaft and the outer expander shaft such that relative axial movement between the inner expander shaft and the outer expander shaft expand or collapse the expander.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the expander includes members configured to move radially outward with distal ends of the inner expander shaft and the outer expander shaft moved closer together.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the one or more cutting elements includes proximally directed cutting points.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the one or more cutting points provide the cutting diameter.
In some aspects, the techniques described herein relate to a method of removing a thrombus, the method including: unsheathing a thrombectomy device distal of a thrombus; proximally retracting an inner expander shaft relative to an outer expander shaft such that members of an expansion device coupled to the inner expander shaft and the outer expander shaft expand radially outward to expand a cutting diameter of a frame of a cutting device; proximally retracting the thrombectomy device to bring the cutting diameter of the frame in contact with the thrombus to cut the thrombus; receiving the cut thrombus through an interior lumen of the frame and into a collection basket; and distally advancing the inner expander shaft relative to the outer expander shaft such that members of the expansion device coupled to the inner expander shaft and the outer expander shaft collapse radially inward to collapse the cutting diameter of the frame.
In some aspects, the techniques described herein relate to a method, further including heating a conductor disposed proximate the cutting diameter.
In some aspects, the techniques described herein relate to a thrombectomy device including: a cutting device including a frame, the frame including: an open distal end; an open proximal end; an interior passage spanning between the open proximal end and the open distal end; and one or more cutting elements disposed at the open proximal end; an expander coupled to the open proximal end, the expander configured to expand and collapse to expand and collapse the open proximal end of the cutting device, wherein the expander is configured to enable a clinician to adjust and maintain a cutting diameter of the one or more cutting elements.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the expander includes a balloon that is configured to be inflated to expand the open proximal end of the cutting device and to be deflated to collapse the open proximal end of the cutting device.
In some aspects, the techniques described herein relate to a thrombectomy device, further including an inner expander shaft and an outer expander shaft, wherein the expander is coupled to the inner expander shaft and the outer expander shaft such that relative axial movement between the inner expander shaft and the outer expander shaft expands or collapses the expander.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the expander includes members configured to move radially outward with distal ends of the inner expander shaft and the outer expander shaft moved closer together.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a conductor and a temperature sensor, the conductor disposed proximate the one or more cutting elements and configured to be heated, and the temperature sensor configured to detect temperature.
In some aspects, the techniques described herein relate to a thrombectomy device including: a collection device including mesh structure with a closed distal end and an open proximal end; and a cutting device including: a cylindrical structure including an open distal end, an open proximal end, and an inner passage extending between the open distal end and open proximal end of the cylindrical structure; a balloon disposed on the cylindrical structure, the balloon configured to expand and collapse; and a cutting element disposed at the proximal end of the cylindrical structure.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the cutting element includes an open truncated cone.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the cutting element includes a cutting ring.
In some aspects, the techniques described herein relate to a thrombectomy device including: a collection device including a mesh structure with a closed distal end and an open proximal end; and a cutting device including: an annular balloon including an open distal end and an open proximal end, the open distal end coupled to the open proximal end of the collection device; and a cutting ring disposed at the open proximal end of the annular balloon.
In some aspects, the techniques described herein relate to a thrombectomy device including: a collection device including a tapered mesh structure with a closed distal end and an open proximal end; a cutting device positioned proximally of the open proximal end of the collection device; and a sheath disposed between the collection device and the cutting device.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a conductor configured to be disposed proximate a thrombus, wherein the conductor is configured to be heated.
In some aspects, the techniques described herein relate to a thrombectomy device including: one or more cutting elements; and an expander configured to expand and collapse to expand and collapse the one or more cutting elements, wherein the expander is configured to enable a clinician to adjust and maintain a cutting diameter of the one or more cutting elements.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the one or more cutting elements includes a plurality of proximally-directed prongs.
In some aspects, the techniques described herein relate to a thrombectomy device, further including an inner expander shaft and an outer expander shaft, wherein relative axial movement between the inner expander shaft and the outer expander shaft expands or collapses the expander.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein distal advancement of the inner expander shaft relative to the outer expander shaft collapses the one or more cutting elements radially inward, and wherein proximal retraction of the inner expander shaft relative to the outer expander shaft expands the one or more cutting elements.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the expander includes a distal portion coupled to the inner expander shaft and a proximal portion coupled to the outer expander shaft.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a plurality of members connected to and expanding between the distal portion and the proximal portion of the expander, wherein the plurality of members are configured to move radially outward when the distal portion and proximal portion of the expander are moved toward each other and move radially inward when then distal portion and proximal portion of the expander are moved away from each other.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a conductor disposed proximate the one or more cutting elements, the conductor configured to be heated.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the conductor is configured to be heated with electrical energy.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the electrical energy is direct current.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the conductor is positioned along a cutting diameter of the one or more cutting elements.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the conductor is positioned along a periphery of an open proximal end of the one or more cutting elements.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the conductor is wire.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a plurality of conductors, wherein the conductor is one of the plurality of conductors.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a temperature sensor configured to sense temperature.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the conductor is configured to be resistively heated.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a frame, wherein the one or more cutting elements are disposed at a proximal portion of the frame.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the frame includes a proximal open end, a distal open end, and an internal passage extending between the proximal open end and the distal open end.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the frame includes a plurality of struts forming diamond-shaped cells.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a collection device coupled to the frame.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a collection device.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the collection device is a mesh bag.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the collection device is a mesh basket.
In some aspects, the techniques described herein relate to a thrombectomy device including: a cutting device including a frame, the frame including: an open distal end; an open proximal end; and an interior passage spanning between the open proximal end and the open distal end; an expander coupled to the open proximal end, the expander configured to expand and collapse to expand and collapse the open proximal end of the cutting device, wherein the expander is configured to enable a clinician to adjust and maintain a diameter of the open proximal end.
In some aspects, the techniques described herein relate to a thrombectomy device, further including an inner expander shaft and an outer expander shaft, wherein relative axial movement between the inner expander shaft and the outer expander shaft expands or collapses the expander.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein distal advancement of the inner expander shaft relative to the outer expander shaft collapses the open proximal end radially inward, and wherein proximal retraction of the inner expander shaft relative to the outer expander shaft expands the open proximal end.
In some aspects, the techniques described herein relate to a thrombectomy device, wherein the expander includes a distal portion coupled to the inner expander shaft and a proximal portion coupled to the outer expander shaft.
In some aspects, the techniques described herein relate to a thrombectomy device, further including a plurality of members connected to and expanding between the distal portion and the proximal portion of the expander, wherein the plurality of members are configured to move radially outward when the distal portion and proximal portion of the expander are moved toward each other and move radially inward when then distal portion and proximal portion of the expander are moved away from each other.
Neither the preceding summary nor the following detailed description purports to limit or define the scope of protection. The scope of protection is defined by the claims. Furthermore, reference is made herein to removing thrombi from veins. One of ordinary skill in the art will understand, after reviewing the entirety of this disclosure, that the systems and methods described herein may be applied to removing thrombi from arteries. Additionally, the systems and methods described herein can be used to remove other occlusions from the body.
The abovementioned and other features of the embodiments disclosed herein are described below with reference to the drawings of the embodiments. The illustrated embodiments are intended to illustrate, but not to limit, the scope of protection. Various features of the different disclosed embodiments can be combined to form further embodiments, which are part of this disclosure.
Although certain embodiments and examples are described below, this disclosure extends beyond the specifically disclosed embodiments and/or uses and obvious modifications and equivalents thereof. Thus, it is intended that the scope of this disclosure should not be limited by any particular embodiments described below. Furthermore, this disclosure describes many embodiments in reference to veins and arteries; the systems and methods described in relation to veins can be applied to arteries and those described in relation to arteries can be applied to veins.
As a thrombus ages, the characteristics of the proximate portion of the vein and the thrombus itself may change, as indicated in the table shown in
For example, initially after formation (e.g., two days post thrombus initiation), a thrombus may be referred to as an acute thrombus. The vein wall proximate the acute thrombus may be thin and have a low collagen content. The main cells found in the vein wall proximate the acute thrombus may be neutrophils. The acute thrombus itself may have no or relatively little collagen. The main cells found in the acute thrombus may be neutrophils. The acute thrombus may be readily detached from the vein wall and/or penetrated.
After some additional time (e.g., six days post thrombus initiation), a thrombus may be referred to as a sub-acute/chronic thrombus. The vein wall proximate the sub-acute/chronic thrombus may be thickened and have a higher collagen content compared to the acute thrombus period. The main cells found in the vein wall proximate the sub-acute/chronic thrombus may be neutrophils and monocytes with the quantity of monocytes significantly increased compared to the acute thrombus period. The sub-acute/chronic thrombus itself may have an increased collagen content compared to the acute thrombus. The main cells found in the sub-acute/chronic thrombus may be neutrophils and monocytes. The sub-acute/chronic thrombus may be more difficult to detach from the vein wall compared to the acute thrombus and/or more difficult to penetrate. The sub-acute/chronic thrombus may have a lower weight compared to the acute thrombus.
After some additional time (e.g., fourteen days post thrombus initiation), a thrombus may be referred to as a chronic thrombus. The vein wall proximate the chronic thrombus may be thickened and have a higher collagen content compared to the sub-acute/chronic thrombus period. The main cells found in the vein wall proximate the chronic thrombus may be monocytes. The chronic thrombus may have an increased collagen content compared to the sub-acute/chronic thrombus. The main cells found in the chronic thrombus may be monocytes. The chronic thrombus may be more difficult to detach from the vein wall compared to the sub-acute/chronic thrombus and/or more difficult to penetrate. The chronic thrombus may have a lower weight compared to the sub-acute/chronic thrombus.
The hardness of a thrombus may increase over time, which may be due to the increase in collagen content. For example, a chronic thrombus may be harder than a sub-acute/chronic thrombus which may be harder than an acute thrombus. A harder thrombus may be more difficult to penetrate, which can make removal more difficult. Additionally, as indicated above, a chronic thrombus may be harder to detach from the vein wall compared to the sub-acute/chronic thrombus which may be harder to detach from the vein wall compared to the acute thrombus.
To remove a thrombus, the vasculature of a patient can be accessed percutaneously. A guide wire 202 can be navigated through the vasculature to a thrombus 108 disposed inside a vein 104. The thrombus 108 can be attached to a wall 118 of the vein 104. As illustrated in
The thrombectomy device 200 can include a tip 206 (e.g., distal tip), which can be tapered and/or bullet shaped. The thrombectomy device 200 can include a sheath 204, which can also be referred to as an outer tube. Components of the thrombectomy device 200 (e.g., collapsed components of the thrombectomy device 200) can be covered by the sheath 204 to ease delivery. The tip 206 can be disposed at the distal end of the sheath 204, which can close the distal end of the sheath 204. The thrombectomy device 200 can be advanced distally over the guide wire 202 through the thrombus 108 to a position distal of the thrombus 108. With the thrombectomy device 200 distal of the thrombus 108, the sheath 204 can be retracted to uncover portions of the thrombectomy device 200, which can include collapsed components of the thrombectomy device 200.
The collection device 222 can also be referred to as a bag, basket, mesh bag, mesh basket, and/or mesh structure. The collection device 222 can include a closed distal end 226 and/or an open proximal end 224. The collection device 222 can include a tapered shape, which can include tapering from the open proximal end 224 to the closed distal end 226. The collection device 222 can include a tubular structure with an open proximal end 224 and closed distal end 226. The collection device 222 can include a mesh structure made from woven filaments. The collection device 222 can include an interior 235 that is accessible from the open proximal end 224. The open proximal end 224 can include a circular or oval opening. The collection device 222 can include the tip 206. The tip 206, which can include a tapered and/or bullet shape, can be disposed at the closed distal end 226. The closed distal end 226 and/or tip 206 can be coupled to an inner shaft 244 (e.g., distal portion of inner shaft 244), which can also be referred to as an inner tube, inner catheter, collection device tube, and/or collection device shaft.
The cutting device 208 can also be referred to as a coring device, cutter, corer, and/or cylindrical structure. The cutting device 208 can include a frame 209. The frame 209 can have a cylindrical and/or tubular shape. The frame 209 can include a plurality of struts 234, which can also be referred to as members. The plurality of struts 234 can be arranged to form a plurality of cells 236. The plurality of cells 236 can include diamond shapes. The cutting device 208 can include an open distal end 230, open proximal end 228, and/or interior lumen 232 extending from the open proximal end 228 to the open distal end 230. The open distal end 230 can be coupled to the open proximal end 224 of the collection device 222. In some variants, the open distal end 230 of the cutting device 208 can couple to the collection device 222 at a position distal of the open proximal end 224 of the collection device 222. The open distal end 230 of the frame 209 can include distal attachment portions 212 that can be coupled to the collection device 222, which can include the open proximal end 224 of the collection device 222. In some variants, the frame 209 can be fastened (e.g., tied), welded, and/or adhered to the collection device 222 (e.g., open proximal end 224 of the collection device 222). In some variants, the frame 209 can be tied and then welded to the collection device 222 (e.g., open proximal end 224 of the collection device 222). In some variants, the cutting device 208 and collection device 222 can be integrally formed. The cutting device 208 can include one or more cutting elements 210, which can include cutting points, sharp points, cutting edges, spikes, prongs, and/or blades. The one or more cutting elements 210 can be disposed at the open proximal end 228 of the frame 209. The one or more cutting elements 210 can be arranged in an annular shape, which can include being distributed circumferentially along the annular shape. The one or more cutting elements 210 can provide a cutting diameter. The one or more cutting elements 210 can be oriented (e.g., point) in a proximal direction to cut a thrombus 108 with proximal retraction of the cutting device 208 into the thrombus 108. The cutting device 208 can include one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, or twenty or more cutting elements 210.
The expansion device 214 can also be referred to as an expander, expansion mechanism, and/or malecot. The expansion device 214 can convert axial movement into radial expansion. The expansion device 214 can include a distal portion 218, which can be an annular structure, ring, and/or band. The distal portion 218 can be coupled to (e.g., disposed on) an inner expander shaft 242, which can also be referred to as an inner expander tube and/or inner expander catheter. The inner shaft 244 can be disposed through the inner expander shaft 242. The inner expander shaft 242 and inner shaft 244 can be moveable relative to each other. The expansion device 214 can include a proximal portion 216, which can be an annular structure, ring, and/or band. The proximal portion 216 can be coupled to (e.g., disposed on) an outer expander shaft 240, which can also be referred to as an outer expander tube and/or outer expander catheter. The inner expander shaft 242 can be disposed through the outer expander shaft 240. The outer expander shaft 240 and inner expander shaft 242 can be moveable relative to each other. The expansion device 214 can include a plurality of members 220, which can also be referred to as struts, cross-pieces, supports, bands, ribbons, and/or wings. The plurality of members 220 can connect to and extend between the proximal portion 216 and the distal portion 218. The plurality of members 220 can include one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen, or twenty or more members 220. The number of members 220 can correspond to the number of cutting elements 210. The plurality of members 220 can curve radially outward from the proximal portion 216 to a vertex 238 and then curve radially inward to the distal portion 218. The cutting elements 210, which can include a portion of the frame 209 proximate the cutting elements 210, can be coupled (e.g., fastened, tied, welded, adhered) to the plurality of members 220. The cutting elements 210 can be coupled to the plurality of members 220 at the vertices 238 of the members 220. In some variants, the cutting elements 210 can be angled inward (e.g. acute angle) to avoid cutting the wall 118 of the vein 104. The cutting elements 210 can be angled inward away from the wall 118. The angle of the cutting elements 210 can also help with reentry into the sheath 204. In some variants, the cutting elements 210 can be coupled to the plurality of members 220 proximally of the vertices 238, which can angle the cutting elements 210 inward.
As illustrated in
AS illustrated in
A clinician can adjust the cutting diameter provided by the cutting elements 210 along a continuum of diameters by adjusting the distance between the proximal portion 216 and distal portion 218. In some variants, the outer expander shaft 240 and/or inner expander shaft 242 can include markings to indicate relative positioning between the outer expander shaft 240 and inner expander shaft 242 that corresponds to certain cutting diameters. In some variants, the thrombectomy device 200 can include one or more features to facilitate stepped (e.g., incremental) adjustment of the diameters.
To form the assembled expansion device 214, the flat pattern for the expansion device 214 can be formed (e.g., rolled) into a tubular structure, which can include being formed (e.g., rolled) around a cylindrical structure. The halved member 220 can be coupled together, which can at least include welding and/or adhering, to hold the expansion device 214 in the tubular shape. A fixture, such as a disk fixture can be disposed between the proximal portion 216 and distal portion 218 to push the plurality of members 220 radially outward. The fixture can be positioned at the attachment portions 246 to form the vertices 238 at the attachment portions 246. In some variants, the expansion device 214 can be heat set with the fixture to create the curvature in the plurality of members 220 illustrated in
In some variants, the total length of the expansion device 214 can be about 1.000 inches. In some variants, the width of the plurality of members 220 can be about 0.021 inches. In some variants, the distance between the radial centers of curvature of opposing curved portions 250 of the proximal portion 216 and distal portion 218 can be about 0.750 inches. An aperture in the attachment portions 246 can be about 0.012 inches.
The frame 209, including the cutting elements 210, can be formed using a cylindrical structure disposed inside the frame 209 that includes at least two consistent diameters—an outer diameter for the tubular structure formed by the plurality of cells 236 and an inner diameter for the offset cutting portions 256—and a curved annular structure extending between and connecting the outer diameter and the inner diameter that can be used to form the inward-projecting portion 254 of the cutting elements 210. The frame 209 can be disposed around the cylindrical structure and formed therewith, which can include heat setting.
In some variants, the length of the cutting device 208 can be about 2.000 inches. The width of the cutting elements 210 can be about 0.039 inches. The width of the holes of the proximal attachment portions 252 can be about 0.012 inches. The width of each of the plurality of struts 234 can be about 0.010 inches. The width of the distal attachment portions 212 can be about 0.039 inches. The width of the holes of the distal attachment portions 212 can be about 0.012 inches.
In use, the thrombectomy device 200 can be advanced distally over the guide wire 202 to position the thrombectomy device 200 distal of the thrombus 108. The sheath 204 an be proximally retracted to uncover the collection device 222, cutting device 208 and expansion device 214. The expansion device 214 can expand radially outward to expand the cutting device 208, which expands the collection device 222. For example, the inner expander shaft 242 can be retracted proximally relative to the outer expander shaft 240 to move the distal portion 218 closer to the proximal portion 216 such that the plurality of members 220 move outward with the cutting elements 210 of the cutting device 208. With the collection device 222, cutting device 208, and expansion device 214 expanded, the thrombectomy device 200 can be proximally retracted to engage the cutting elements 210 with the thrombus 108. The expansion device 214 can hold the cutting elements 210 at a desired cutting diameter, which can include at the wall 118 of the vein 104 or radially inward thereof to core a thrombus 108 to restore blood flow therethrough. The expansion device 214 can provide sufficient hoop stress and/or compression force to maintain the cutting elements 210 at a desired cutting diameter. As described herein, portions of the cutting device 208 (e.g., open proximal end 228 and/or cutting elements 210) and/or expansion device 214 can be energized to ease cutting of the thrombus 108. In some variants, an energized element (e.g., conductor, wire) can be disposed at (e.g., wrapped around) portions of the cutting device 208 (e.g., open proximal end 228 and/or cutting elements 210) and/or expansion device 214 to ease cutting the thrombus. The cutting elements 210 can cut the thrombus 108, which can include coring the thrombus 108. The cut thrombus 108 can be moved into the open proximal end 228, through the interior lumen 232, out the open distal end 230 of the frame 209 of the cutting device 208 and into the interior 235 of the collection device 222 through the open proximal end 224 as the thrombectomy device 200 is proximally retracted. With the thrombus 108 in the collection device 222, the expansion device 214 can be collapsed to collapse the cutting device 208 and collection device 222, which can trap the thrombus 108 within the collection device 222. The expansion device 214 can be collapsed radially inward by distally advancing the inner expander shaft 242 relative to the outer expander shaft 240 to move the distal portion 218 away from the proximal portion 216 such that the plurality of members 220 move inward with the cutting elements 210 of the cutting device 208. The collapsed thrombectomy device 200 can be retraced proximally out of the patient with the trapped thrombus 108. In some variants, the relative positioning of the
The thermal device 122 can include a conductor 124 (e.g., wire, element, heated conductor). The conductor 124 can be at least solid or braided. The conductor 124 may include one or more materials. For example, the conductor 124 may include a metal, such as steel (e.g., stainless steel) and/or an alloy of nickel and titanium (e.g., Nitinol).
The thermal device 122 can include various software and hardware components to implement aspects of this disclosure, which may at least include a temperature modulation unit 130, controller 132, and/or power source 134 or at least an interface to receive energy from a power source. The conductor 124 may be operatively connected to a temperature modulation unit 130. The temperature modulation unit 130 may adjust the temperature of the conductor 124 (e.g., electrode, heating element, heater, etc.). For example, the temperature modulation unit 130 may raise the temperature (e.g., heat) of the conductor 124. The temperature modulation unit 130 may heat the conductor 124 directly or indirectly with one or more energy sources, which may at least include heat, radio frequency, laser, electricity (e.g., current, direct current, alternative current), resistive heating, inductive heating, nuclear, heated liquid, and/or others. For example, the temperature modulation unit 130 may apply a current of electricity to the conductor 124, raising the temperature of the conductor 124. In some variants, the temperature modulation unit 130 may lower the temperature (e.g., cool) the conductor 124. The temperature of the wire 124 may be automatically modulated based on monitored conditions (e.g., sensed with a temperature sensor) in a blood vessel and/or at the thrombus. The temperature of the conductor 124 may be adjusted to accommodate convection losses. The temperature of the conductor 124 may be controlled by a clinician. The controller 132 may be operatively connected with the temperature modulation unit 130 to perform the temperature control described herein by way of the temperature modulation unit 130. The conductor 124 can, in some variants, be heated to any temperature or range of temperatures between 10 and 300 degrees Celsius. In some variants, the conductor 124 can be heated to any temperature or range of temperatures between 10 and 200 degrees Celsius. In some variants, the conductor 124 can be heated to any temperature or range of temperatures between 10 and 200 degrees Celsius. In some variants, the conductor 124 can be heated to any temperature or range of temperatures between 10 and 50 degrees Celsius. In some variants, the conductor 124 can be heated to any temperature below 10 degrees Celsius.
The power source 134 may be a battery, which may include a rechargeable battery and/or disposable one-time-use battery. The power source 134 may power the thermal device 122, which can include the controller 132 and/or temperature modulation unit 130. The power source 134 may supply the energy to adjust the temperature (e.g., heat) the conductor 124. In some variants, the thermal thrombectomy system 122 may be operatively connected to an external power source.
The thermal device 122 may also include memory, communication interface(s) (wired or wireless), user interfaces (e.g., button(s), dial(s), switch(es), display(s), touchpad(s), touchscreen(s), knob(s), trigger(s), indicator(s), gauge(s), and/or slider(s)), etc. to implement aspects of the disclosure. The temperature modulation unit 130, controller 132, power source 134, and/or other components of the thermal thrombectomy system 122 may be housed in a housing 128, which may be a handle.
The thermal device 122 may include insulation 126, which may also be referred to as a covering. The insulation 126 may insulate the conductor 124 from the anatomy of the patient, such as the blood vessel. The insulation 126 may be disposed over a proximal portion of the conductor 124, which may include being disposed over the entirety of the conductor 124 except a distal portion. The conductor 124, in some variants, may be deployed from and retracted into the insulation 126. In some variants, the insulation 126 may be an insulating coating disposed on the conductor 124.
The conductor 124 can be disposed around features of the thrombectomy device 200 described herein to provide energy (e.g., heat) to ease penetrating, passing, and/or cutting the thrombectomy device 200. In some variants, the conductor 124 delivers energy (e.g., heat) to one or more features of the thrombectomy device 200 to energize the one or more features themselves. The conductor 124 can be heated, which can include being heated with electrical energy such as direct current. The conductor 124 can include a first portion carrying electrical energy distally and a second portion carrying electrical energy proximally. The conductor 124 can form a loop that is routed around features of the thrombectomy device 200. In addition to providing heat, the structure of the conductor 124 can cut the thrombus.
The conductor 124 can be disposed on various portions of the thrombectomy device 200. For example, the conductor 124 can be disposed on the collection device 222, cutting device 208 (e.g., cutting elements 210), expansion device 214, and/or outer expander shaft 240. The conductor 124 can be heated as described herein to provide heat for cutting. Proximal portions of the conductor 124 can be covered with insulation 126, which can help protect anatomy. In some variants, the conductor 124 can include one or more conductor 124 (e.g., one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve or more conductors 124). With multiple conductors 124, the conductors 124 can be separately routed to different portions of the thrombectomy device 200.
As illustrated in
The thrombectomy device 308 can include a cutting device 312 (e.g., coring device). The device 312 can include a cylindrical structure 314. The cylindrical structure 314 can include a distal opening 322, a proximal opening 324, and an interior 326 extending between the proximal opening 324 and the distal opening 322. The distal opening 322 can be coupled to the open proximal end of the collection device 310. The cylindrical structure 314 can include a cutting element 318, which can be a cutting ring. The cutting element 318 can be disposed at the proximal opening 324 of the cylindrical structure 314. The cutting element 318 can include a cutting ring that is fixed in size and/or shape. In some variants, the cutting element 318 can include a cutting ring that is expandable. In some variants, the cylindrical structure 314 can be replaced with a spring that can provide a working lumen. The spring can enable the thrombectomy device 308 to be further collapsed for deliver through smaller sized sheath 204. A proximal end of the cutting spring can include the cutting element 318, which can be a cutting ring.
The cutting device 312 can include a balloon 316. In some variants, the balloon 316 can be non-compliant. The balloon 316 can be disposed on the cylindrical structure 314. The balloon 316 can include an annular shape. The thrombectomy device 308 can include an inflation tube 332 to deliver a medium (e.g., gas, fluid) to the balloon 316. The inflation tube 332 can routed through the interior 326 of the cylindrical structure 314 to deliver the medium to the balloon 316 through a side opening 320 in the cylindrical structure 314. The inflated balloon 316 can engage the wall 118 of the vein 104, which can center the proximal opening 324 and/or cutting element 318 for coring the thrombus 108 during proximal retraction. The balloon 316 can be inflated periodically to assure balloon 316 is expanding to maximum profile of wall 118.
The thrombectomy device 308 can include an inner shaft 330 that can be disposed through the cylindrical structure 314 and collection device 310. The thrombectomy device 308 can include an outer shaft 338 through which the inner shaft 330 can extend. The outer shaft 338 can extend through the sheath 204. The inflation tube 332 can extend through the sheath 204. The thrombectomy device 308 can include a proximal attachment portion 336, which can be an annular structure, that can be coupled to the outer shaft 338 or inner shaft 330. Members 334 can extend distally from the proximal attachment portion 336 and couple with the cylindrical structure 314 and/or collection device 310.
In use, the collapsed thrombectomy device 308 can be disposed within the sheath 204 and advanced distally over a guide wire 202 disposed through the inner shaft 330 to a position distal of a thrombus 108. The sheath 204 can be proximally retracted. Medium can be delivered to the balloon 316 to expand the balloon 316. The collection device 310 can be self-expanding or manually expanded by way of translating one or more shafts, such as the inner shaft 330 and/or outer shaft 338. With the balloon 316 expanded, the proximal opening 324 and/or cutting element 318 can be centered relative to the wall 118 of the vein 104. The thrombectomy device 308 can be retracted proximally to engage the cutting element 318 with the thrombus 108 which can cut a portion (e.g., core) of the thrombus 108. The cut thrombus 108 can move into the proximal opening 324, through the interior 326, and out the distal opening 322 into the interior of the collection device 310 as the thrombectomy device 308 is retracted proximally. The balloon 316 and/or collection device 310 can be collapsed, which can include deflating the balloon 316. The thrombectomy device 308 with the trapped thrombus can be retracted proximally out of the patient.
In some variants, the cutting element 318 can include a diameter of 5-6 mm. In some variants, the sheath 204 can be 17 Fr. In some variants, the balloon 316 can be 10-15 mm.
The cutting device 346 can include a balloon 350, which can have an annular shape. The balloon 350 can include an open distal end 358 that can be coupled to the proximal open mouth 360 of the collection device 348. The balloon 350 can include a proximal open end 354 proving access into an interior lumen 356 of the cutting device 346 (e.g., balloon 350). The interior lumen 356 can connect the proximal open end 354 and open distal end 358. The cutting device 346 can include a cutting ring 352, which can be angled (e.g., having a slope when viewed from the side). The thrombectomy device 344 can be disposed on an inner shaft 366.
In use, the thrombectomy device 344 can be routed to distal of a thrombus 108 and unsheathed. The balloon 350 can expand the cutting device 346. The collection device 348 can self-expand. The expansion of the balloon 350 can expand the cutting ring 352 disposed at a proximal open end 354 of the balloon 350. The thrombectomy device 344 with the expanded cutting device 346 and collection device 348 can be proximally retracted into a thrombus 108 to cut the thrombus 108. The cut thrombus can move into the proximal open end 354, through the interior lumen 356, and out the open distal end 358 and into the interior of the collection device 348 by way of the proximal open mouth 360. The cutting device 346 can be collapsed by deflating the balloon 350.
The cutting device 384 can include a mesh cutting basket that can have a ball-like shape. The cutting device 384 can include a closed proximal end 386, which can be tapered, and a closed distal end 388, which can be tapered. The distal end 388 can be secured to the inner shaft 366 with a distal attachment portion 398. The closed proximal end 386 can be secured to the outer shaft 402, which can receive the inner shaft 366 therethrough, with a proximal attachment portion 400. A sleeve 404, which can have an annular shape that is bowl-like, can be disposed between the cutting device 384 and the collection device 390. In use, the thrombectomy device 382 can be disposed distally of a thrombus and unsheathed to expand. The thrombectomy device 382 can be proximally retracted to cut the thrombus with the cutting device 384. The cut thrombus 108 can move through the sleeve 404 and into the collection device 390 by way of the open proximal end 392 for removal.
The cutting device 408 can include a plurality of cutting blades 412. The cutting blades 412 can be twisted. The cutting blades 412 can curve around a central longitudinal axis of the thrombectomy device 406. The cutting device 408 can be disposed on an outer main shaft 414. An inner main shaft 416 can be disposed through the cutting device 408, which can include radially inward of the cutting device 408. The inner shaft 366 can pass through the inner main shaft 416 and outer main shaft 414. In some variants, the cutting device 408 can collapse or expand by way of axial and/or rotational movement of one or more of the shafts illustrated in
The thrombectomy device 423 can include a cutting device 424 with a frame 426 and an inner mesh 428, which can help the frame 426 to expand. The frame 426 can include a distal end 432 coupled to the open proximal end 440 of the collection device 436 and an proximal end 430 providing access into an interior lumen 434 extending between and connecting the open proximal end 430 and open distal end 432. The frame 426 can include cutting elements 444 at the open proximal end 440, which can include being circumferentially distributed about the open proximal end 440.
The thrombectomy device 423 can include an expansion mechanism 449. The expansion mechanism 449 can include a proximal attachment portion 448, which can be an annular structure, coupled to an outer shaft 442. The expansion mechanism 449 can include a plurality of members 446 that can extend distally and radially outward from the proximal attachment portion 448 to the frame 426 of the cutting device 424. In some variants, with relative axial movement between the inner shaft 366 and the outer shaft 442, the cutting device 424 can be collapsed or expanded.
In use, the thrombectomy device 423 can be disposed distal of a thrombus 108, expanded, and proximally retracted to engage the cutting elements 444 with the thrombus 108 to cut the thrombus 108. The cut thrombus 108 can move into the proximal end 430, through the interior lumen 434, and out the distal end 432 of the cutting device 424 and into the collection device 436 by way of the open proximal end 440 for removal.
The actions, steps, methods, etc. described herein can be performed by a clinician (e.g. surgeon) and/or robot.
The collection devices described herein can include tubular structures. The collection devices can include open proximal ends and closed distal ends. The collection devices can be tapered. The collection devices can include meshed structures, which can include fine mesh. The meshed structures can include a weave of filaments. The collection devices can include bags and/or baskets.
In some variants, the thrombectomy devices described herein can be used with a variety of cutting ring sizes. The thrombectomy devices described herein can, in some variants, be collapsed back into a delivery sheath for multiple passes on a thrombus if necessary. Cutting rings can be sharp, serrated, energized, heated, and/or cooled. Cutting rings can be sharp, semi-circle, and/or spoked.
In some variants, the sheaths described herein can be 9-10 Fr. In some variants, the sheath described herein can be 7-8 Fr. In some variants, the guide wires described herein can be 0.035 inches. In some variants, one or more features described herein can self-expand, which can include cutting devices, frames, collection devices (e.g., bags, baskets), and/or other features. For example, one or more features can include Nitinol that is set to self-expand.
The thrombectomy devices described herein can at least be used in sub-acute and chronic occlusions for post-thrombotic syndrome, in-stent restenosis, AV fistula, etc. The shafts described herein can include internal lumens. The shafts described herein can be tubes.
Although the systems and methods have been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the systems and methods extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the embodiments and certain modifications and equivalents thereof. Various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the systems and methods. The scope of this disclosure should not be limited by the particular disclosed embodiments described herein.
Methods of using the foregoing system(s) (including device(s), apparatus(es), assembly(ies), structure(s) or the like) are included; the methods of use can include using or assembling any one or more of the features disclosed herein to achieve functions and/or features of the system(s) as discussed in this disclosure. Methods of manufacturing the foregoing system(s) are included; the methods of manufacture can include providing, making, connecting, assembling, and/or installing any one or more of the features of the system(s) disclosed herein to achieve functions and/or features of the system(s) as discussed in this disclosure.
Certain features that are described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations, one or more features from a claimed combination can, in some cases, be excised from the combination, and the combination may be claimed as any subcombination or variation of any subcombination.
Moreover, while operations may be depicted in the drawings or described in the specification in a particular order, such operations need not be performed in the particular order shown or in sequential order, and all operations need not be performed, to achieve the desirable results. Other operations that are not depicted or described can be incorporated in the example methods and processes. For example, one or more additional operations can be performed before, after, simultaneously, or between any of the described operations. Further, the operations may be rearranged or reordered in other implementations. Also, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described components and systems can generally be integrated together in a single product or packaged into multiple products. Additionally, other implementations are within the scope of this disclosure.
Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include or do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments.
Conjunctive language, such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.
Some embodiments have been described in connection with the accompanying drawings. Components can be added, removed, and/or rearranged. Orientation references such as, for example, “top” and “bottom” are for ease of ease of discussion and may be rearranged such that top features are proximate the bottom and bottom features are proximate the top. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.
In summary, various embodiments and examples of thermal thrombectomy devices, systems, and methods have been disclosed. Although the systems and methods have been disclosed in the context of those embodiments and examples, it will be understood by those skilled in the art that this disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and/or other uses of the embodiments, as well as to certain modifications and equivalents thereof. This disclosure expressly contemplates that various features and aspects of the disclosed embodiments can be combined with, or substituted for, one another. Accordingly, the scope of this disclosure should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.
This application claims the priority benefit of U.S. Provisional Application No. 63/602,141, filed Nov. 22, 2023, which is hereby incorporated by reference in its entirety. All applications for which a foreign or domestic priority is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.
| Number | Date | Country | |
|---|---|---|---|
| 63602141 | Nov 2023 | US |
