Atherectomy system and method using atherectomy system

Abstract

To provide a system that minimizes an atherectomy device applicable to a target portion having a small diameter, and a use method.SOLUTION: An atherectomy system 100 includes at least facing two end portions 102, 104 and one wire 101. The two end portions 102, 104 define a length of the wire 101. A helical screw 103 connected along a length direction of the wire 101 is configured to rotate together with the wire 101, and includes a tubular element 105 passing over a portion of the length. The tubular element 105 may include a tip 107 having at least one blade structure 109. The helical screw 103 may be configured to generate a negative pressure in the inside of the tubular element 105 at the time of rotation of the wire 101. A configuration may be adopted in which the negative pressure in the inside of the tubular element 105 draws a substance toward the tip 107 and enables the helical screw 103 and at least one blade structure 109 to cut the substance.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] TECHNICAL FIELD This application relates generally to systems and methods for disrupting and removing material from tubular tissue. [Background technology]

[0002] Atherectomy procedures can be performed to remove atherosclerotic plaque deposits from arteries. For example, subjects with atherosclerosis may develop deposits of fatty deposits, cholesterol, calcium, and other substances on their arterial walls, putting them at risk for narrowing and hardening of the arteries. A typical approach to performing atherectomy utilizes a catheter device equipped with a cutting, crushing, or light-emitting element to remove material from within the artery. For example, such devices can be inserted into a target site within the artery and activated to break up the plaque deposits, which can then be removed via suction or irrigation. However, existing approaches may not be suitable for certain vessels due to the complexity of miniaturizing the device, increased risk of complications, and reduced efficiency and removal rate of plaque. For example, small target sites may increase the risk of bladed, crushing, or other mechanisms contacting and damaging the vessel wall. As another example, devices that rotate along an eccentric path may not achieve a complete rotation within small-diameter vessels and may even impinge on the vessel wall. Thus, existing approaches have not yet solved the problem of minimizing atherectomy devices for smaller diameter target sites. Summary of the Invention

[0003]

[0003] Embodiments of the present disclosure relate to atherectomy systems, atherectomy kits, and methods of using the same. An exemplary atherectomy system of the present disclosure may include at least one wire having two opposing ends, the two opposing ends defining a length of the at least one wire; a helical screw coupled to the at least one wire along the length of the at least one wire between the two opposing ends, the helical screw configured to rotate with the at least one wire; and a tubular element threaded over a portion of the length, the tubular element including a tip having at least one blade structure, the helical screw configured to generate a negative pressure within the tubular element upon rotation of the at least one wire, the negative pressure within the tubular element configured to draw material toward the tip and enable cutting of the material against the helical screw and the at least one blade structure.

[0004] In some embodiments, each blade structure of the at least one blade structure includes a rounded outer surface and at least one sharp inner edge. In some embodiments, the at least one blade structure includes a plurality of blade structures arranged radially. In some embodiments, the rounded outer surface of each of the plurality of blade structures defines a hemisphere having a central cavity and a plurality of cavities radially spaced apart between each blade structure. In some embodiments, the tubular element is configured to remain stationary relative to rotation of the at least one wire. In some embodiments, the system further includes an end cap coupled onto the at least one wire at one of two opposing ends. In some embodiments, the connection between the end cap and the at least one wire includes at least one polymer material. In some embodiments, the connection between the end cap and the at least one wire includes at least one soldering material.

[0005] In some embodiments, the system further comprises at least one rotation mechanism operably connected to the at least one wire, the at least one rotation mechanism configured to rotate the at least one wire upon actuation. In some embodiments, the at least one wire comprises a plurality of wires. In some embodiments, the at least one wire comprises stainless steel. In some embodiments, the at least one wire comprises nitinol. In some embodiments, the at least one wire comprises at least one radiopaque material. In some embodiments, the helical screw comprises stainless steel. In some embodiments, the helical screw comprises tungsten carbide. In some embodiments, the helical screw comprises at least one radiopaque material.

[0006] Exemplary kits may include one or more atherectomy systems described herein and shown in the accompanying drawings. For example, the kit may include one or more systems described above. In some embodiments, the kit further includes at least one guidewire, and the one or more systems of the kit are configured to be deployed to a target site over the at least one guidewire. In some embodiments, the kit includes a first system including respective tubing elements with a first bore diameter and a second system including respective tubing elements with a second bore diameter, the second bore diameter being greater than the first bore diameter.

[0007] An exemplary method of use for the disclosed atherectomy system (or kit) can include removing material from a target site within a tubular tissue. The exemplary method includes deploying a guidewire into a target tubular tissue containing the target material, inserting an atherectomy system (such as one or more of the exemplary systems described above) into the tubular tissue over the guidewire, rotating at least one wire via a rotation mechanism coupled to one of two opposing ends of the at least one wire, and advancing a tip of a helical screw into the target material, wherein the rotation of the at least one wire causes rotation of the helical screw, which draws the target material into the tip of the tubular element, and the at least one blade structure and the helical screw cut the target material in a region adjacent to the tip of the tubular element.

[0008] In some embodiments, severing of the target material occurs through collective engagement of the target material with the helical screw and at least one blade structure. In some embodiments, the method further includes aspirating the target material from the subject through the tubular element. In some embodiments, the target material includes at least one clot. In some embodiments, the rotation of the at least one wire is performed at a speed of at least 10,000 revolutions per minute (RPM). In some embodiments, the target material includes plaque, one or more emboli (e.g., thrombus, foreign body, fatty globules), etc. In some embodiments, the method further includes retracting the atherectomy system from the tubular tissue along the guidewire.

[0009] Having thus described embodiments of the present disclosure in general terms, reference is now made to the accompanying drawings, which are not necessarily drawn to scale, and in which: [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a left perspective view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 2]FIG. 1 is a right perspective view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 3] FIG. 1 is a partial perspective view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 4A] FIG. 1 is a front view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 4B] FIG. 1 is a rear view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 5A] FIG. 1 is a top view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 5B] FIG. 1 is a bottom view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 5C] FIG. 1 is a left side view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 5D] FIG. 1 is a right side view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 6] FIG. 1B is a left perspective view of an exemplary tubular element according to some embodiments of the present disclosure. [Figure 7] FIG. 1B is a right perspective view of an exemplary tubular element according to some embodiments of the present disclosure. [Figure 8] FIG. 10 is a rear perspective view of an exemplary tubular element according to some embodiments of the present disclosure. [Figure 9A] FIG. 1 is a front view of an exemplary tubular element according to some embodiments of the present disclosure. [Figure 9B] FIG. 10 is a rear view of an exemplary tubular element according to some embodiments of the present disclosure. [Figure 10A] FIG. 1 is a left side view of an exemplary tubular element according to some embodiments of the present disclosure. [Figure 10B] FIG. 1B is a right side view of an exemplary tubular element according to some embodiments of the present disclosure. [Figure 11] FIG. 1 is a perspective view of an exemplary wire structure according to some embodiments of the present disclosure. [Figure 12]FIG. 1 is a partial perspective view of an exemplary wire structure according to some embodiments of the present disclosure. [Figure 13] FIG. 1 is a perspective view of an exemplary helical screw according to some embodiments of the present disclosure. [Figure 14] FIG. 1 is a partial perspective view of an exemplary helical screw according to some embodiments of the present disclosure. [Figure 15] 1 is a diagram of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 16] 1 is a diagram of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 17] 1 is a diagram of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 18] FIG. 1 is a perspective view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 19] FIG. 1 is a partial perspective view of an exemplary atherectomy system according to some embodiments of the present disclosure. [Figure 20] 1 is a flowchart of an exemplary atherectomy process according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0011] Certain embodiments of the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all, embodiments of the invention are shown. Like reference numerals refer to like elements throughout the drawings. Indeed, various embodiments of the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.

[0012] As used herein, the term "or" is used in both the alternative and connective sense unless otherwise indicated. The term "along" and similarly used terms mean near or on the edge or other location referenced, but not necessarily directly on the edge or other location referenced. The terms "about," "generally," and "substantially" refer to within manufacturing and / or engineering design tolerances for corresponding materials and / or elements, unless otherwise indicated. Therefore, use of any such above-mentioned terms or similarly interchangeable terms should not be construed as limiting the spirit and scope of embodiments of the present invention.

[0013] As used herein, "atherectomy system" refers to a system for performing an atherectomy procedure. An atherectomy procedure may involve engaging and removing material from tubular tissue. However, the present disclosure contemplates that the disclosed systems and methods may be equally applicable to other applications where a reduced diameter cutting system is advantageous. For example, an atherectomy system may be used in other material removal procedures, such as embolus removal, bowel obstruction removal, etc.

[0014] As used herein, the terms "atherectomy system" and "auger wire" may be used interchangeably to refer to a system configured to disrupt material and remove material from tubular tissue.

[0015] overview Generally, various embodiments of the present disclosure provide improved designs for atherectomy systems. For example, the present disclosure provides various embodiments for atherectomy systems that can be deployed into tubular tissue via a catheter and rotated to cut and remove targeted material, such as plaque. The various atherectomy systems described and illustrated herein can exhibit a reduced spatial profile compared to conventional systems for removing material from tubular tissue. In doing so, the atherectomy systems of the present invention can overcome challenges associated with removing material from small diameter blood vessels. It is understood and appreciated that such contexts are provided by way of example, and that use of the atherectomy systems in additional contexts, such as use in other medical procedures, is contemplated and within the scope of the present invention.

[0016] As discussed above, existing atherectomy systems face challenges in effectively and safely removing targeted material from small-diameter tubular structures, such as small arteries and veins. For example, miniaturization of laser- and / or acoustic-based atherectomy systems may not be feasible. As another example, using front- and side-bladed directional atherectomy systems in small-diameter vessels may increase the risk of cutting tissue. As yet another example, miniaturization of burr- or drill-based rotational atherectomy systems may be impractical due to constraints such as motor size and operational complexity.

[0017] To address these and other issues, exemplary implementations of embodiments herein can provide an atherectomy system that includes a torquable wire along with a helically wound wire to transmit rotational motion at high speeds (e.g., 10,000 RPM or greater). In various embodiments, upon rotation, the helically wound wire ("helical screw") can transport targeted material from tubular tissue into the tip of a tubular element. A wire-based means of peeling and transporting targeted material can support maneuverability of the atherectomy system in small-diameter tubular tissue.

[0018] One or more blade structures at the tip of the tubular element may engage the helical screw and cut the target material with a scissors-like action as the helical screw pulls the target material against the blade structure. The blade structures may include sharp inner edges and rounded and / or blunt outer edges and surfaces. Internalizing the sharp edges may reduce the likelihood of tissue damage. For example, in contrast to existing techniques that cut or puncture target material from the outside within tubular tissue, the atherectomy system of the present invention may cut the target material from the inside so that sharp edges and surfaces are not exposed to the tubular tissue. The rounded outer surface and blunt outer edges of the tubular element may reduce the likelihood of puncturing or tearing tissue when the atherectomy system is advanced through the tubular tissue.

[0019] In this manner, the atherectomy systems described below improve the safety and feasibility of removing target material from small-diameter blood vessels or other tubular structures. By incorporating cutting edges within the system, the likelihood of tissue damage may be reduced. Furthermore, the helical screw and wire-based means for engaging and transporting target material improves the maneuverability of the atherectomy system through tortuous paths. In this manner, the atherectomy systems may provide a means to achieve significant reduction in the bulk of target material from small-diameter environments while reducing the risk of complications.

[0020] Exemplary Atherectomy System 1 , a left perspective view of an exemplary atherectomy system 100 is shown. In some embodiments, atherectomy system 100 includes one or more wires 101, a helical screw 103 attached along the length of wire 101, and a tubular element 105 through which wire 101 and helical screw 103 can be inserted. In various embodiments, one or more wires 101 and helical screw 103 are configured to rotate together in response to torque applied to wire 101. In some embodiments, tubular element 105 is configured to remain stationary relative to the rotation of helical screw 103 and one or more wires 101.

[0021] In some embodiments, the wire 101 includes two opposing ends 102, 104 that define a length of the wire 101. In some embodiments, the wire 101 is attachable to a rotation mechanism that applies torque to the wire 101 (e.g., rotates the wire 101) at a rotational speed of 10,000 revolutions per minute (RPM) or greater. For example, a chuck mechanism may couple or connect the wire 101 to the rotation mechanism such that torque may be applied to the wire 101 via actuation of the rotation mechanism. In some embodiments, the atherectomy system 100 includes multiple wires 101. For example, the atherectomy system 100 may include multiple wires 101 that may be torqued as a single assembly. In some embodiments, the multiple wires 101 are attached to one another via soldering, laser welding, adhesive bonding, etc. so that the wires 101 may rotate together. For example, the multiple wires 101 may be attached to one another so that torque may be applied collectively. In some embodiments, each wire 101 is joined to one another along a subset of the total length of the wire 101. For example, multiple wires 101 may be welded, glued, or otherwise joined to one another in one or more sections, with the remaining subset of each wire remaining unjoined.

[0022] In some embodiments, wire 101 comprises stainless steel, nitinol, or the like. In some embodiments, wire 101 comprises one or more radiopaque materials. For example, wire 101 comprises one or more radiopaque markers, such as barium sulfate markers or other radiopaque contrast agents. In some embodiments, wire 101 has a circular cross-section. Alternatively, in some embodiments, wire 101 has an elliptical cross-section. In some embodiments, the plurality of interconnect wires 101 exhibits varying cross-sections. For example, the plurality of wires 101 may include a first subset of wires having circular cross-sections and a second subset of wires having elliptical cross-sections.

[0023] In some embodiments, the helical screw 103 comprises a wire having a helical shape. In some embodiments, the helical screw 103 has an elliptical cross-section. Alternatively, in some embodiments, the helical screw 103 has a circular cross-section. In various embodiments, the helical screw 103 is coupled to the one or more wires 101 along the length of the one or more wires 101 between two opposing ends 102, 104. For example, the helical screw 103 may be connected to the wires 101 via soldering, laser welding, adhesives, etc. In some embodiments, the helical screw 103 is configured to rotate with the one or more wires 101. For example, the helical screw 103 may be rotated via torque applied to the end 102 of the one or more wires 101. In some embodiments, the helical screw 103 is configured to generate a negative pressure within the tubular element 105 upon rotation of the one or more wires 101, thereby drawing material toward and into the tubular element 105. As described further herein, the helical screw 103 and one or more blade structures 109 of the tubular element 105 can cut material. For example, the helical screw 103 and blade structures 109 can cut material in a scissor-like manner through collective engagement between the helical screw 103 and the sharp inner edges of the blade structures. In some embodiments, the helical screw 103 comprises stainless steel, tungsten carbide, or the like. In some embodiments, the helical screw 103 comprises one or more radiopaque materials. For example, the helical screw 103 includes one or more radiopaque markers, including barium sulfate or other radiopaque contrast agents. In some embodiments, the helical screw 103 is integrally formed with the one or more wires 101.

[0024] In some embodiments, the tubular element 105 has a cylindrical portion. In some embodiments, one end of the cylindrical portion includes a hemispherical (e.g., semi-spherical) portion that embodies the tip 107 of the tubular element 105. The tubular element 105 may include a central cavity through which the helical screw 103 and one or more wires 101 may be inserted. In some embodiments, the tip 107 includes one or more blade structures 109. In some embodiments, the blade structures 109 are configured to cut material proximate to the tip 107 via engagement between the blade structures 109 and the helical screw 103. In some embodiments, the tip 107 includes multiple blade structures 109 in a radial array. The multiple blade structures 109 may be spaced apart from one another in the radial array such that gaps exist between adjacent blade structures. In some embodiments, the tubular element 105 includes titanium, one or more titanium-containing alloys, tungsten carbide, or the like. In some embodiments, tubing element 105 includes one or more radiopaque materials.

[0025] 2 shows a right perspective view of an exemplary atherectomy system 100. As shown, the atherectomy system 100 may include multiple wires 101 arranged in a helical structure. A helical screw 103 may be coupled to the helical structure. For example, the helical screw 103 may embody one or more wires attached around the helical structure.

[0026] In some embodiments, the plurality of wires 101 includes a central cavity 201. In some embodiments, the central cavity 201 is configured to receive a guidewire or the like to guide the atherectomy system 100 to a target site in a tubular tissue. In some embodiments, the one or more wires 101 and the helical screw 103 are flexible so that the atherectomy system 100 may be guided through a tortuous environment. For example, the helical screw 103 and the plurality of wires 101 may be configured to bend or flex while guiding the atherectomy system 100 through one or more blood vessels.

[0027] 3 shows a partial perspective view of an exemplary atherectomy system 100. In various embodiments, the tip 107 includes multiple blade structures. For example, the tip 107 can include multiple blade structures 109A, 109B, and 109C in a radial arrangement. In some embodiments, each blade structure includes a sharp inner edge that engages the rotating helical screw 103 to cut material adjacent the tip 107. For example, the blade structures 109A, 109B, and 109C can include inner edges 301A, 301B, and 301C, respectively, that are configured to engage the helical screw 103 and cut material drawn toward the tip 107 of the tubular element 105. In some embodiments, each blade structure includes a rounded outer surface with a blunt outer edge. For example, blade structures 109A, 109B, 109C may include rounded outer surfaces 303A, 303B, 303C with blunt outer edges 306. In various embodiments, the rounded surfaces define a hemispherical shape of tip 107. In some embodiments, the hemisphere includes a central cavity, a radial array of multiple blade structures, and multiple radially spaced cavities between adjacent blade structures. For example, blade structures 109A and 109B may be spaced apart in a radial array such that cavities 305A exist between adjacent blade structures. Furthermore, blade structures 109B and 109C may be spaced apart in a radial array such that cavities 305B exist between adjacent blade structures.

[0028] In some embodiments, the blunt outer edge of the rounded outer surface includes a radius 307, which transitions the outer edge to a surface that defines a gap between adjacent blade structures. In some embodiments, radius 307 is 0.0254 mm. In some embodiments, the blunt outer edge of the rounded outer surface includes a radius 309. In some embodiments, radius 309 ranges between 0.005 millimeters (mm) and 0.7 mm. For example, radius 309 may be 0.406 mm.

[0029] FIG. 4A shows a front view of an exemplary atherectomy system 100A. The tip 107 of the tubular element 105A can include any suitable number of blade structures (e.g., 1, 3, 5, 6, or any other suitable number). For example, as shown in FIG. 4A, the tubular element 105A can include five blade structures 109 arranged radially and spaced apart by five cavities 305. In some embodiments, the cavities 305 allow material to enter the tip 107 from the side of the tubular element 105 (e.g., within the tip 107, the blade structures can cut material along with the helical screw 103). FIG. 4B shows a rear view of the exemplary atherectomy system 100B. As shown in FIGS. 4A and 4B, the atherectomy systems 100A, 100B can include a central cavity 201A, 201B extending longitudinally through the plurality of wires 101, the helical screw 103, and the tubular element 105.

[0030] FIG. 5A shows a top view of an exemplary atherectomy system 100A.

[0031] FIG. 5B shows a bottom view of the exemplary atherectomy system 100.

[0032] FIG. 5C shows a left side view of the exemplary atherectomy system 100.

[0033] FIG. 5D shows a right side view of the exemplary atherectomy system 100.

[0034] 6 illustrates a left perspective view of an exemplary tubular element 105. As shown, the tubular element 105 includes a generally cylindrical shape between a first end 602 and a second end 604. In various embodiments, the tip 107 of the tubular element 105 extends from the second end 604 and includes a plurality of blade structures 109 that define a hemispherical shape.

[0035] 7 shows a right perspective view of an exemplary tubular element 105. In various embodiments, material entering the tip 107 through the cavity 305 (or open distal front) can be severed via engagement of the inner edge 301 with a helical screw (not shown). In some embodiments, the severed material can be further drawn (subject to negative pressure, movement of the screw, etc.) into a central cavity 701 of the tubular element 105. As further shown in the rear perspective view of FIG. 8, the central cavity 701 can extend longitudinally through the tubular element 105.

[0036] FIG. 9A shows a front view of an exemplary tubular element 105.

[0037] FIG. 9B shows a rear view of the exemplary tubular element 105.

[0038] FIG. 10A shows a left side view of an exemplary tubular element 105.

[0039] FIG. 10B shows the right side of the exemplary tubular element 105.

[0040] FIG. 11 shows a perspective view of an exemplary wire structure 1101. In some embodiments, an atherectomy system of the present disclosure includes a wire structure 1101 comprising multiple wires arranged in a helical configuration. For example, the wire structure 1101 can include multiple wires 101A, 101B, 101C, 101D, 101E, 101F (or more) that are at least partially joined to one another and wound in a helical configuration. In some embodiments, the wire structure 1101 includes a central cavity (see, e.g., central cavity 201 shown in FIG. 2 and described herein). Additionally, in some embodiments, the wire structure 1101 includes a helical passage 1106 configured to receive a portion of a helical screw (not shown). For example, a helical screw can be disposed within the helical passage 1106 and coupled (e.g., via soldering, laser welding, adhesive, etc.) to one or more wires embodying the wire structure 1101. The partial perspective view of FIG. 12 further shows the wire structure 1101 and the helical passage 1106 formed along the length of the wire structure 1101.

[0041] FIG. 13 shows a perspective view of an exemplary helical screw 103. In some embodiments, the helical screw 103 embodies a helical-shaped wire extending between two opposing ends 1301, 1303. The helical screw 103 may embody a right-handed or left-handed helical shape. In various embodiments, the helical screw 103 includes a central cavity 1302 through which a guidewire or the like may be inserted. The partial perspective view of FIG. 14 further shows the central cavity 1302 of the helical screw 103.

[0042] 15 shows a diagram of an exemplary atherectomy system 100. In some embodiments, the helical screw 103, 103′ and one or more wires 101 may rotate at high speed, creating a pressure gradient in a direction toward the tips 107, 107′ of the tubing elements 105, 105′. The tubing elements 105, 105′ may remain stationary relative to the rotation of the helical screw 103 and wire 101. The rotation of the helical screw 103, 103′ and wire 101 may further cause the application of negative pressure within the tubing elements 105, 105′. In various embodiments, the negative pressure draws material toward and into the tips 107, 107′. In some embodiments, the inner edge 301, 301′ of each of the plurality of blade structures 109, 109′ engages the rotating helical screw 103, 103′, thereby applying shear stress (e.g., scissor action) that cuts the material into smaller pieces. In some embodiments, negative pressure further aspirates the cut material into the tubular element 105, 105′ and potentially into a collection catheter or the like, removing the material from the subject.

[0043] In various embodiments, by providing sharp edges only on the interior portion of the blade structure 109, the atherectomy system 100 may reduce the likelihood of damaging the tissue or other tissue of the subject. Additionally, the rounded exterior surface 303 of the blade structure 109 may reduce the likelihood of piercing the tissue or other tissue of the subject that may come into contact with the tip 107. In this manner, the atherectomy system 100 may overcome challenges associated with safely disrupting and removing material from small diameter, tortuous tubular tissue, such as blood vessels.

[0044] 16 shows a diagram of an exemplary atherectomy system 100. One or more wires 101 can rotate in a first direction, causing rotation of an attached helical screw 103 in the first direction. Rotation of the wires 101 and helical screw 103 can create a pressure gradient (e.g., negative pressure) toward the tip 107 and central cavity 701 of the tubular element 105. In some embodiments, material is drawn into the tip 107 through the exposed front portion. Additionally or alternatively, in some embodiments, material is drawn into the tip 107 through cavities 305 between radially arranged blade structures 109.

[0045] 17 shows a diagram of an exemplary atherectomy system 100. In some embodiments, one or more wires 101 and a portion of the helical screw 103 are inserted into target material 1701. The target material 1701 may include plaque, thrombus, foreign debris, etc. In various embodiments, the wire 101 and the helical screw 103 are advanced into the target material 1701, bringing the tip 107 of the tubular element 105 into contact with the target material 1701. In some embodiments, the tip 107 is biased (e.g., pressed) against the target material 1701 so that the one or more blade structures 109 maintain contact with the target material 1701 throughout the cut. In some embodiments, the wire 101 and helical screw 103 rotate at high speed (e.g., 10,000 RPM, 20,000 RPM, or another suitable value), sucking the target material 1701 into the tip 107, where the inner edges 301 of the helical screw 103 and one or more blade structures 109 collectively engage to cut the target material 1701.

[0046] FIG. 18 shows a perspective view of an exemplary atherectomy system 100. In some embodiments, a wire structure 1101 composed of multiple wires 101 includes a termination cap 1801. In some embodiments, the termination cap 1801 is configured to reduce the likelihood that one or more wires 101 will pierce or otherwise damage tissue or other tissue of a subject. For example, the termination cap 1801 may provide a barrier between the wire ends and the subject. In some embodiments, the termination cap 1801 includes one or more polymers, metallic materials, etc. For example, the termination cap 1801 may include a soldering material composed of one or more metals.

[0047] In some embodiments, the depth 1803 of the blade structure 109 is increased to expose a longer portion of the helical screw 103 to material within the tubular tissue. By exposing a longer portion of the helical screw to fluid, plaque, emboli, etc. within the tubular tissue, the increased depth 1803 may compensate for reduced suction pressure when the rotational speed is reduced. In some embodiments, the depth 1803 of the blade structure 109 may be configured to accommodate various types, sizes, and / or volumes of target material. For example, in situations where low-density, non-calcified plaque is being removed, a blade structure 109 with a greater depth 1803 may be utilized compared to a blade structure with a smaller depth that may be utilized in situations where calcified plaque is being removed. As another example, a blade structure 109 with a greater depth 1803 may be utilized when removing plaque with a larger cross-sectional area.

[0048] 19 shows a partial perspective view of an exemplary atherectomy system 100. In some embodiments, the helical screw 103 embodies one or more wires coupled around the plurality of wires 101. The helical screw 103 and the inner edges 301 of each blade structure 109 can collectively engage to cut target material in a region proximate the tip 107. In various embodiments, the plurality of wires 101 are operably connected to a rotation mechanism via one or more clamps. For example, clamps (e.g., chucks, etc.) having radial symmetry can be coupled onto each end of the plurality of wires 101. A motor can rotate the clamps to apply torque to the plurality of wires 101.

[0049] Example Uses Having described an exemplary atherectomy system according to the present disclosure, exemplary steps of the present disclosure will now be described. It should be understood that the flowchart illustrates exemplary steps that can be performed using one or more of the atherectomy systems described herein. For example, the atherectomy process 2000 illustrated in the flowchart of FIG. 20 and described herein may be performed using one or more of the atherectomy systems 100 illustrated in FIGS. 1-5 and 15-19, respectively, and described herein. In some embodiments, one or more steps are performed using a kit including one or more atherectomy systems. For example, the atherectomy process 2000 may be performed using a kit including a first atherectomy system 100 and a second atherectomy system 100. The first atherectomy system 100 may include a tubular element 105 having a first bore diameter, and the second atherectomy system 100 may include a tubular element 105 having a second bore diameter. The second hole diameter can be smaller than, larger than, or equal to the first hole diameter. In some embodiments, one of a plurality of atherectomy systems can be utilized from the kit based at least in part on the diameter of the target tubular tissue, target material, etc. In some embodiments, the kit further includes one or more guidewires configured to be inserted into the subject and guided to the target site to enable deployment of the atherectomy system at the target site over the guidewire.

[0050] In some embodiments, the kit includes one or more connection mechanisms configured to connect the atherectomy system to a rotation mechanism. In some embodiments, the kit further includes a rotation mechanism. For example, the kit may include a power drill and a clamp. The clamp may be secured onto the wires 101 of the atherectomy system 100 to enable rotation of the wires 101 and the helical screw 103 via the power drill.

[0051] The illustrated blocks represent the operations of each process. Such operations may be performed in any of several ways, including, but not limited to, in the order and manner shown and described herein. In some embodiments, one or more blocks of any of the processes described herein occur between one or more blocks of another process, before one or more blocks of another process, simultaneously with one or more blocks of another process, and / or as a sub-step of a second process. Additionally or alternatively, any of the processes of various embodiments may include some or all of the operational steps described and / or shown, including one or more optional blocks in some embodiments. With respect to the flowcharts shown herein, one or more of the block(s) shown in some embodiments are optional in some or all embodiments of the present disclosure. It should be understood that one or more of the operations of each flowchart may be combined and substituted and / or altered in other ways described herein.

[0052] 20 shows a flow chart illustrating the operations of an exemplary atherectomy process 2000 for disrupting material and removing targeted material from vascular tissue. For example, process 2000 may be performed to disrupt and remove plaque from a blood vessel.

[0053] In some embodiments, in block 2003, process 2000 includes directing a guidewire into the tubular tissue of the subject. For example, the guidewire may be inserted through an incision into an artery of the subject and directed through the artery of the subject to a particular segment of the artery or a second vessel (e.g., another artery, vein, etc.). The tubular tissue may contain one or more target materials, such as plaque, emboli, etc.

[0054] In some embodiments, in block 2006, process 2000 includes deploying an atherectomy system into the tubular tissue over a guidewire. For example, atherectomy system 100 can be deployed into the target tubular tissue over an inserted guidewire. Alternatively, in some embodiments, atherectomy system 100 is guided through the subject to the target tubular tissue without the use of a guidewire. In some embodiments, the position of the guidewire, atherectomy system, etc. can be determined via one or more medical imaging techniques. For example, the position of the atherectomy system can be obtained via fluoroscopy, x-ray, computed tomography (CT), ultrasound, positron emission tomography (PET), etc.

[0055] In some embodiments, in block 2009, process 2000 includes advancing at least one wire and a helical screw (e.g., coupled around the at least one wire) into the target material of the tubular tissue. For example, multiple wires 101 secured to one another and a helical screw 103 coupled around the multiple wires 101 may be inserted into a plaque, an embolus, etc. In some embodiments, the insertion of the helical screw and one or more wires is verified using one or more medical imaging techniques. For example, radiopaque markers on the helical screw, wire, etc. may be imaged via fluoroscopy or x-ray to verify the position of the atherectomy system relative to the subject and the target material. In some embodiments, the helical screw and one or more wires are inserted into the target material such that the tip of a tubular element of the atherectomy system is pressed against the target material. For example, as shown in FIG. 17, a helical screw 103 and one or more wires 101 can be inserted into the clot so that the tip 107 of the tubular element 105 contacts the clot.

[0056] In some embodiments, in block 2012, process 2000 includes rotating at least one wire to rotate a helical screw. For example, multiple wires 101 may be rotated to cause rotation of a helical screw 103 coupled to the multiple wires 101. In some embodiments, process 2000 includes connecting a rotation mechanism to one end of one or more wires (e.g., a second end of the wire opposite the first end and inserted into the target material). Each end of the one or more wires may be outside the subject. In some embodiments, the wire and helical screw are rotated at a speed of at least 10,000 RPM. Additionally or alternatively, in some embodiments, the wire and helical screw are rotated at a speed of at least 20,000 RPM. In some embodiments, the position of the wire and helical screw relative to the target material is adjusted throughout performance of blocks 2012-2018. For example, the wire and helical screw may be advanced further into the target material during performance of block 2015. In various embodiments, rotation of the helical screw creates a pressure gradient within the tip of the tubular element of the atherectomy system. For example, rotation of the helical screw 103 can create a negative pressure within the tip 107 of the tubular element 105 that draws the target material.

[0057] In some embodiments, in block 2015, process 2000 includes severing the target material through collective engagement of the helical screw of the atherectomy system and one or more blade structures of the tubular element. For example, the helical screw 103 and the inner edge 301 of the blade structure 109 may collectively engage and cut the target material as it passes through the tip 107 of the tubular element 105. The helical screw 103 may pull the target material against the inner edge of the blade structure, thereby cutting the target in a scissors-like manner. In some embodiments, the outer edge and surface of the blade structure are rounded and / or blunt to reduce the likelihood of cutting or piercing the target tubular or other tissue. In various embodiments, the end of the atherectomy system that is inserted into the target material may be referred to as the “proximal end,” and the opposite end of the atherectomy system may be referred to as the “distal end.” In some embodiments, rotation of the helical screw further advances the cut portion of the target material through the tubular element toward the distal end of the atherectomy system.

[0058] In some embodiments, in block 2018, process 2000 includes removing the severed target material from the tubular tissue. For example, the severed target material may be further aspirated and / or pushed through the tubular element 105 of the atherectomy system 100 and aspirated from the tubular tissue. Additionally or alternatively, in some embodiments, the severed target material may be flushed from the tubular tissue. In some embodiments, the severed target material is received into a collection catheter, and the catheter may be removed from the subject to remove the target material. Removal of the severed target material may occur simultaneously or asynchronously with further advancement and rotation of the helical screw and one or more wires into the tubular tissue.

[0059] Conclusion Although some embodiments described herein relate to atherectomy systems, those skilled in the art will understand that the teachings herein may also be applied to a wide range of medical procedures and devices. The embodiments described herein may be expandable to accommodate at least the applications described above. Various components of the embodiments described herein may be added, removed, rearranged, modified, or duplicated, etc., as those skilled in the art may find advantageous and / or necessary to implement a particular application in conjunction with the teachings of the present disclosure. In some embodiments, specific features, characteristics, materials, components, and / or equipment may be applied as those skilled in the art may find advantageous and / or necessary to implement a particular application in conjunction with the teachings of the present disclosure.

[0060] Moreover, numerous modifications and other embodiments of the present disclosure set forth herein will come to mind to those skilled in the art having the benefit of the teachings herein and presented in the foregoing description and the associated drawings. It is therefore to be understood that the present disclosure is not limited to the particular embodiments disclosed, and that modifications and other embodiments are intended to be included within the scope of any appended claims. Furthermore, while the foregoing description and associated drawings describe exemplary embodiments in the context of particular example combinations of elements and / or functions, it should be understood that alternative embodiments may provide various combinations of elements and / or functions without departing from the scope of any appended claims. In this regard, for example, different combinations of elements and / or functions than those expressly described above are also contemplated as being part of any appended claim. Although specific terms are employed herein, these terms are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

1. 1. A system comprising: at least one wire having two opposing ends, the two opposing ends defining a length of the at least one wire; a helical screw coupled to the at least one wire along the length of the at least one wire between the two opposing ends, the helical screw configured to rotate with the at least one wire; a tubular element threaded over a portion of said length; Equipped with the tubular element includes a tip having at least one blade structure; the helical screw is configured to generate a negative pressure within the tubular element upon rotation of the at least one wire; The system is configured such that the negative pressure within the tubular element draws material toward the tip, enabling cutting of the material against the helical screw and the at least one blade structure.

2. Each blade structure of the at least one blade structure comprises: a rounded outer surface; at least one sharp inner edge; The system of claim 1 , comprising:

3. The system of claim 2 , wherein the at least one blade structure comprises a plurality of radially arranged blade structures.

4. The system of claim 3 , wherein the rounded outer surface of each of the plurality of blade structures defines a hemisphere having a central cavity and a plurality of cavities radially spaced between each of the blade structures.

5. The system of claim 1 , wherein the tubular element is configured to remain stationary relative to rotation of the at least one wire.

6. The system of claim 1 , further comprising a termination cap coupled onto the at least one wire at one of the two opposing ends.

7. The system of claim 6 , wherein the connection between the termination cap and the at least one wire comprises at least one polymer material.

8. The system of claim 6 , wherein the connection between the termination cap and the at least one wire comprises at least one soldering material.

9. further comprising at least one rotation mechanism operably connected to the at least one wire; The system of claim 1 , wherein the at least one rotation mechanism is configured to rotate the at least one wire when activated.

10. The system of claim 1 , wherein the at least one wire comprises a plurality of wires.

11. The system of claim 1 , wherein the at least one wire comprises stainless steel.

12. The system of claim 1 , wherein the at least one wire comprises nitinol.

13. The system of claim 1 , wherein the at least one wire comprises at least one radiopaque material.

14. The system of claim 1 , wherein the helical screw comprises stainless steel.

15. The system of claim 1 , wherein the helical screw comprises tungsten carbide.

16. The system of claim 1 , wherein the helical screw includes at least one radiopaque material.

17. A kit comprising: At least one system according to any one of claims 1 to 16; at least one guidewire; Equipped with The at least one system is configured to be deployed to a target site via the at least one guidewire.

18. The at least one system comprises: a first system comprising tubular elements each having a first bore diameter; a second system comprising tubular elements of respective second bore diameters; 18. The kit of claim 17, wherein the second hole diameter is greater than the first hole diameter.

19. 1. A method comprising: deploying a guidewire into a target tract containing the target material; Inserting the system of claim 1 into the tubular tissue over the guidewire; rotating the at least one wire via a rotation mechanism coupled to one of the two opposing ends of the at least one wire; advancing the tip of the helical screw into the target material; Including, rotation of the at least one wire causes rotation of the helical screw; rotation of the helical screw draws the target material into the tip of the tubular element; The method, wherein the at least one blade structure and the helical screw cut the target material in a region adjacent the tip of the tubular element.

20. 20. The method of claim 19, wherein severing of the target material occurs through collective engagement of the target material with the helical screw and the at least one blade structure.

21. 20. The method of claim 19, further comprising aspirating the target material from the subject through the tubing element.

22. 20. The method of claim 19, wherein the target material comprises at least one coagulum.

23. 20. The method of claim 19, wherein the rotation of the at least one wire is performed at a speed of at least 10,000 revolutions per minute (RPM).

24. 20. The method of claim 19, wherein the target material comprises at least one of plaque and an embolus.

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