Rotary cutting device and method

Abstract

Some embodiments of the atherectomy device may (partially or completely) remove stenotic lesions in a blood vessel by rotating one or more abrasive elements in an orbital path to abrade and disrupt the lesions. In particular embodiments, a plurality of abrading elements are arranged along a distal portion of a drive shaft having an improved configuration to facilitate effective navigation into smaller blood vessels below the ankle or in the heart and effective orbital paths for abrading stenosing substances in these smaller blood vessels.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Application 18 / 523,683, filed November 29, 2023, which claims the benefit of U.S. Provisional Application Serial No. 63 / 542,438, filed October 4, 2023, and U.S. Provisional Application Serial No. 63 / 523,583, filed June 27, 2023, the contents of each of which are incorporated herein by reference in their entirety. Technical Field

[0003] This document relates to a rotary cutting device and system for removing or reducing stenotic lesions in blood vessels, for example, by actuating one or more grinding elements in orbital motion within the blood vessel to remove (partially or completely) stenotic lesion material. Background Technology

[0004] Atherosclerosis, the formation of plaque that blocks arteries, is usually the result of coronary heart disease or other vascular problems in the body. Plaque can form from fat, cholesterol, calcium, and other substances found in the blood. Over time, the plaque hardens and narrows the arteries. This restricts the flow of oxygen-rich blood to organs and other parts of the body.

[0005] Blood flow through central and peripheral arteries (e.g., carotid, iliac, femoral, renal arteries, etc.) can be similarly affected by the development of atherosclerotic blockages. For example, peripheral artery disease (PAD) can be severe because insufficient blood flow can cause irreversible damage to the kidneys, legs, arms, and feet. Without treatment, tissues may die or become infected. In another example, coronary artery disease (CAD) is caused by the buildup of atherosclerotic material in one or more coronary arteries and can lead to a lack of blood, oxygen, and nutrients to the heart muscle.

[0006] Rotary cutting can be used to treat this type of blockage in some types of blood vessels. In some forms of rotary cutting, a drive shaft carrying a grinding drill or other abrasive surface (e.g., with diamond grit or diamond particles) rotates at high speed within the vessel, and the clinician slowly advances the cutting device distally, causing the grinding drill to scrape the occluded lesion and grind it into very small particles, thereby reducing the blockage and improving blood flow through the vessel. Although rotary cutting is usually performed in larger arteries in the leg, such a procedure can be obstructed in smaller arteries, such as those below the ankle (e.g., in the foot) or particularly in coronary arteries (e.g., in the left anterior descending coronary artery or the left circumflex coronary artery), especially where the vessel diameter is typically 3 mm or less and the entry path follows a tortuous route. Summary of the Invention

[0007] Some embodiments of the rotational atherectomy system described herein can remove (partially or completely) stenotic lesions in blood vessels by rotating one or more abrasive elements in a track path to abrade and disrupt the lesions. In particular embodiments, multiple abrasive elements are arranged along a distal portion of a drive shaft with improved configurations / relative dimensions to facilitate effective navigation to smaller blood vessels (below the ankle or in the heart) and effective track paths for abrading stenotic material in such smaller blood vessels. Additionally, some versions of the improved configurations of multiple abrasive elements arranged along a drive shaft can also be effective for removing or reducing stenotic lesions in larger blood vessels (e.g., those in the leg above the ankle or larger coronary arteries), thereby providing the user with the option for effectively treating multiple arterial sites in a single surgical procedure.

[0008] In one aspect, the present disclosure relates to a rotational atherectomy device for removing stenotic lesion material from a patient's pedal or coronary artery. The device can include an elongate flexible drive shaft defining a longitudinal axis and including a torque transmitting coil of one or more filaments helically wound about the longitudinal axis from a distal end to a proximal end in a filament winding direction. The device can also include one or more abrasive burrs fixedly mounted to a distal portion of the torque transmitting coil (e.g., a series of abrasive burrs as shown below). Optionally, the abrasive burrs can have a maximum burr diameter of no more than 1.25 mm. At least one of the abrasive burrs can be an eccentric abrasive burr having a center of mass offset from the longitudinal axis to operate in a rotational direction opposite the filament winding direction.

[0009] In another aspect, the present disclosure describes a method for rotational atherectomy in a pedal artery below the ankle. The method can include advancing a torque transmitting coil of a rotational atherectomy device over a guidewire and into a pedal artery below the ankle such that at least one abrasive burr mounted to a distal portion of the torque transmitting coil is proximate to a stenotic lesion within the pedal artery. Additionally, the method can also include rotating the torque transmitting coil of the rotational atherectomy device such that the at least one abrasive burr mounted to the torque transmitting coil abrades the stenotic lesion within the pedal artery.

[0010] Another aspect presented in the present disclosure is a method for rotational atherectomy in a coronary branch artery of a heart. The method can include advancing a torque transmitting coil of a rotational atherectomy device over a guidewire into a coronary branch artery of a heart such that at least one abrasive burr mounted to a distal portion of the torque transmitting coil is proximate to a stenotic lesion within the coronary branch artery. The method can also include rotating the torque transmitting coil of the rotational atherectomy device such that the at least one abrasive burr mounted to the torque transmitting coil abrades the stenotic lesion within the coronary branch artery.

[0011] Other aspects set forth in the disclosure include at least one of a 4 French introducible atherectomy device, a pedal artery loop navigable atherectomy device, and a coronary artery branch navigable atherectomy device (as described in detail below).

[0012] In another aspect, the disclosure describes an atherectomy system. The system can include one or more torque transmitting coils of filaments helically wound from a distal end to a proximal end along a winding direction of the filaments to define a coil diameter and a drive shaft axis. The system can also include one or more abrasive burrs fixedly mounted to a distal portion of the torque transmitting coil (e.g., a series of abrasive burrs as shown below). Optionally, each abrasive burr can have an outer burr diameter such that a burr to coil diameter ratio of all of the abrasive burrs along the torque transmitting coil is 1.3 to 1.7. The system can also include an atherectomy handle assembly coupled to a proximal end of the torque transmitting coil. Optionally, the atherectomy handle assembly can house an electric motor configured to drive rotation of the abrasive burrs about the drive shaft axis in a rotational direction in response to user input at an actuator of the atherectomy handle assembly.

[0013] In yet another aspect, the disclosure relates to an atherectomy device for removing stenotic lesion material from an artery. The device can include an elongate flexible drive shaft defining a longitudinal axis and including one or more torque transmitting coils of filaments helically wound about the longitudinal axis from a distal end to a proximal end along a winding direction of the filaments. The device can also include a series of abrasive burrs fixedly mounted to a distal portion of the torque transmitting coil and having a maximum burr diameter of no more than 1.25 mm. Optionally, an intermediate abrasive burr in the series of abrasive burrs is an eccentric abrasive burr having a center of mass offset from the longitudinal axis to operate in a rotational direction opposite the winding direction of the filaments. The series of abrasive burrs can also include a proximal abrasive burr and a distal abrasive burr each having a center of mass coaxial with the longitudinal axis.

[0014] Another aspect of this disclosure is a rotary cutting system comprising a torque transmission coil, a series of abrasive drills, and a rotary cutting handle assembly. The torque transmission coil may include one or more filaments spirally wound from distal to proximal end along a filament winding direction to define a coil diameter and a drive shaft axis. A series of abrasive drills may be fixedly mounted to the distal portion of the torque transmission coil and, optionally, may have a maximum drill diameter not exceeding 1.25 mm. This series of abrasive drills may include a distal concentric abrasive drill, a proximal concentric abrasive drill, and a central eccentric abrasive drill. Optionally, the distal concentric abrasive drill is coaxially mounted to the distal end of the torque transmission coil; the proximal concentric abrasive drill has the same dimensions as the distal concentric abrasive drill and is coaxially mounted to the torque transmission coil at a position no greater than 0.5 inches from the distal end of the torque transmission coil; and the central eccentric abrasive drill has a larger dimensions than the distal and proximal concentric abrasive drills and is mounted to the torque transmission coil with its center of mass offset from the drive shaft axis. Additionally, the rotary cutting handle assembly can be coupled to the proximal end of the torque transmission coil and can house an electric motor configured to drive a series of grinding drills to rotate about the drive shaft axis in the direction of rotation in response to user input at the actuator of the rotary cutting handle assembly.

[0015] Some embodiments described herein can provide one or more of the following advantages. First, some embodiments of the rotary cutting system can be configured to provide rotary cutting treatment in small arteries, such as those below the ankle (e.g., in the foot) or in coronary arteries (e.g., in the left anterior descending coronary artery or the left circumflex coronary artery). In some examples described below, the orientation, relative spacing, and relative size of the grinding elements along the distal portion of the drive shaft (as well as other characteristics of the drive shaft) can collectively achieve an effective access path to such small arteries, including those with a vessel diameter typically 3 mm or less and an access path that follows a tortuous route.

[0016] Secondly, some embodiments of the rotary cutting device and system provided herein can advantageously advance through a relatively small percutaneous entry point, such as an entry point in the patient's thigh with a small inserter sheath, and can have a sufficient balance of factors (e.g., length, maximum lateral radius from the central axis, flexibility, torque transmission capability, etc.) to advance into the patient's foot or heart to remove (completely or partially) stenotic material from the target artery. In a particular version described below, the rotary cutting device may take the form of a "4-French-accessible" device, as used herein, which refers to a rotary cutting device in which the maximum radius (measured from the central longitudinal axis of the torque transmission coils) of all torque transmission coils and the abrasive elements thereon is smaller than the central entry path of the 4-French-accessor sheath, thereby providing slidable insertion through the 4-French-accessor.

[0017] Third, in some embodiments of the rotary cutting apparatus and system described herein, the relative size ratio between the diameter of each abrasive element and the coil diameter of the drive shaft is 1.7 or less. In the specific examples described below, this relative size ratio is referred to as the drill-to-coil diameter ratio and can be selected according to the teachings herein to advantageously provide a drive shaft that can pass through the stenotic lesion in the artery and then achieve a trajectory path (e.g., a trajectory path larger than the maximum resting diameter of the abrasive element) during rotation to abrade the stenotic lesion. In some embodiments, the drill-to-coil diameter ratio can be about 1.3-1.7 for all abrasive elements along the torque transmission coil of the drive shaft. For example, the drill-to-coil diameter ratio can be 1.5-1.6 for the largest abrasive element mounted to the torque transmission coil, and 1.3-1.4 for the smallest abrasive element mounted to the torque transmission coil. In another example, for each eccentric grinding element mounted to the torque transmission coil, the drill-to-coil diameter ratio may be 1.5-1.6, and for each concentric grinding element mounted to the torque transmission coil, the drill-to-coil diameter ratio may be 1.3-1.4.

[0018] Fourth, in some embodiments of rotary cutting devices and systems comprising multiple abrasive elements (at least one of which has a centroid offset from the central axis of the drive shaft), these abrasive elements are longitudinally spaced, advantageously with a compressed length of less than 5 cm from the farthest end of the drive shaft (preferably 2 cm or less from the farthest end of the drive shaft), and the combined radial angles of all abrasive elements differ by less than 120 degrees along a specific length of the drive shaft (e.g., less than 90 degrees for the embodiment shown herein). This design can advantageously facilitate the advancement of the eccentric abrasive elements into tortuous arterial paths and arterioles, and then (during rotation) achieve a trajectory path for grinding the target stenotic material from the arterial wall.

[0019] Fifth, some embodiments of the rotary cutting apparatus and system provided herein may include an improved control handle that enables simplified setup and convenient operation for clinicians. In a particular example, the control handle may be a single-use, disposable unit housing an electric motor (for driving the rotation of the drive shaft) and a fluid pump (for delivering saline or other fluids toward the distal end of the drive shaft). Optionally, a controller for the handle (which includes a processor and a memory storing control instructions) may be housed in a separate, screenless housing (e.g., a power adapter unit that plugs into a standard wall socket). In such alternative implementations, the controller does not require a user interface screen; instead, user interface buttons are provided along the control handle, which is connected to the controller via a detachable cable. Thus, in these alternative implementations, the controller can be reused over time along with multiple control handles (all of which are single-use, disposable units), thereby advantageously saving costs while maintaining convenient disposability of the drive shaft and the handle.

[0020] Sixth, some embodiments of the rotary cutting device and system provided herein can advantageously take the form of a “foot artery ring navigable” device, which is used herein to refer to a rotary cutting device, wherein the torque transmission coil provides flexibility as it advances through a tortuous path to the foot artery ring below the ankle, and the orientation and size of the grinding element are designed to advance through the stenotic lesion within the foot to perform rotary cutting treatment within the foot.

[0021] Seventh, some embodiments of the cutting apparatus and system provided herein can advantageously take the form of a “coronary branch navigable” device, which is used herein to refer to a cutting apparatus, wherein the torque transmission coil provides flexibility as it advances through a tortuous path to the branch coronary artery of the heart (e.g., the left anterior descending coronary artery or the left circumflex coronary artery), and the orientation and size of the grinding element are designed to advance through the stenotic lesion within the branch coronary artery to perform cutting treatment in the heart.

[0022] Eighth, some embodiments of the rotary cutting device and system provided herein may include an improved handle and sheath that facilitates retraction of the abrasive element into and from the sheath. When the rotary cutting device is navigated to small arteries, such as those below the ankle (e.g., in the foot) or coronary arteries (e.g., in the left anterior descending coronary artery or the left circumflex coronary artery), the retraction of the abrasive element within the sheath advantageously covers the abrasive drill. The cutting device can advantageously advance to the target area while the abrasive surface of the abrasive element is separated from the vessel wall, thereby reducing the likelihood of scraping or engaging unintended areas of the body's vessels along the navigation path. Conversely, the cutting device is configured to smoothly navigate through complex anatomy (e.g., particularly along smaller arterial pathways) when the abrasive element is in a retracted position within the distal end of the sheath lumen, and then adjust the abrasive element distally from the sheath lumen after navigation to the target site (e.g., for rotary cutting treatment).

[0023] Ninth, some embodiments of the rotary cutting apparatus and system provided herein can facilitate improved safety and ease of operation of the rotary cutting apparatus. For example, the system can be configured to automatically prevent rotation of the drive shaft (and the abrasive element thereon) when the abrasive element is in a first longitudinal position (e.g., retracted within the sheath cavity), and to provide selective initiation of rotation of the drive shaft when the abrasive element is in a second longitudinal position (e.g., adjusted to extend distally from the sheath). Therefore, this system provides enhanced safety control, facilitating improved and intuitive operation for the user both during the navigation of the drive shaft (when the abrasive element is within the sheath) and during the rotary cutting treatment after reaching the target position (allowing user-controlled rotation of the abrasive element after it extends from the sheath).

[0024] Details of one or more embodiments of the invention are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the invention will become apparent from the specification, drawings, and claims. Attached Figure Description

[0025] Figure 1 This is a perspective view of an example rotary cutting system according to some embodiments.

[0026] Figure 2 yes Figure 1 A longitudinal side view of the rotary cutting device of the system.

[0027] Figure 3 yes Figure 2 A remote view of the rotary cutting device.

[0028] Figure 4 In blood vessels Figure 1 A perspective view of the distal portion of an example rotary cutting system.

[0029] Figure 5 yesFigure 2 A transverse cross-sectional view of the distal end of the rotary cutting device.

[0030] Figure 6 According to some embodiments, in the foot blood vessels below the ankle Figure 1 A perspective view of the distal portion of an example rotary cutting system.

[0031] Figure 7 It is in the blood vessels of the foot below the ankle. Figure 6 An enlarged perspective view of the distal portion of an example rotary cutting system.

[0032] Figure 8 This is a longitudinal side view of an alternative embodiment of the distal portion of the rotary cutting device according to some embodiments.

[0033] Figure 9 yes Figure 8 A remote view of the rotary cutting device.

[0034] Figure 10 This is a longitudinal side view of an alternative embodiment of the distal portion of the rotary cutting device according to some embodiments.

[0035] Figure 11 yes Figure 10 A remote view of the rotary cutting device.

[0036] Figure 12 This is a longitudinal side view of an alternative embodiment of the distal portion of the rotary cutting device according to some embodiments.

[0037] Figure 13 yes Figure 12 A remote view of the rotary cutting device.

[0038] Figure 14 This is a longitudinal side view of an alternative embodiment of the distal portion of the rotary cutting device according to some embodiments.

[0039] Figure 15 yes Figure 14 A remote view of the rotary cutting device.

[0040] Figure 16 According to some embodiments, in coronary arteries Figure 14 A perspective view of the distal portion of an example rotary cutting device.

[0041] Figure 17 This is a longitudinal side view of an alternative embodiment of the distal portion of the rotary cutting device according to some embodiments.

[0042] Figure 18 yes Figure 17 A remote view of the rotary cutting device.

[0043] Figure 19This is a longitudinal side view of an alternative embodiment of the distal portion of the rotary cutting device according to some embodiments.

[0044] Figure 20 yes Figure 19 A remote view of the rotary cutting device.

[0045] Figure 21 This is a longitudinal side view of an alternative embodiment of the distal portion of the rotary cutting device according to some embodiments.

[0046] Figure 22 yes Figure 21 A remote view of the rotary cutting device.

[0047] Figure 23 This is a longitudinal side view of an alternative embodiment of the distal portion of the rotary cutting device according to some embodiments.

[0048] Figure 24 yes Figure 23 A remote view of the rotary cutting device.

[0049] Figure 25 This is a longitudinal side view of an alternative embodiment of the distal portion of the rotary cutting device according to some embodiments.

[0050] Figure 26 yes Figure 25 A remote view of the rotary cutting device.

[0051] Figure 27 This is a perspective view of an example rotary cutting system according to some embodiments.

[0052] Figure 28 According to some embodiments Figure 27 A longitudinal side view of a rotary cutting system, wherein the rotary cutting device is in an exemplary proximal position.

[0053] Figure 29 yes Figure 28 Longitudinal side view of the distal end of the rotary cutting system and rotary cutting device.

[0054] Figure 30 According to some embodiments Figure 27 A longitudinal side view of a rotary cutting system, wherein the rotary cutting device is in an exemplary proximal operating position.

[0055] Figure 31 yes Figure 30 A longitudinal side view of the far end of the rotary cutting system and rotary cutting device.

[0056] Figure 32 According to some embodiments Figure 27 A longitudinal side view of a rotary cutting system, wherein the rotary cutting device is in an exemplary distal operating position.

[0057] Figure 33 yes Figure 32 A longitudinal side view of the far end of the rotary cutting system and rotary cutting device.

[0058] Figure 34 It comes from Figure 30 Detailed cross-sectional view of region 34 of the rotary cutting system.

[0059] Figure 35 It comes from Figure 28 Detailed cross-sectional view of region 34 of the rotary cutting system.

[0060] The same reference numerals in the various figures denote the same elements. Detailed Implementation

[0061] refer to Figure 1 In some embodiments, the rotary cutting system 100 for removing stenotic lesions 107 (partially or completely) from a target vessel 105 may include an actuator handle assembly 110 for controlling the movement of an elongated flexible drive shaft assembly 130. The drive shaft assembly 130 includes a flexible drive shaft 136, and the distal portion of the drive shaft 136 includes one or more abrasive elements 140a-c configured to grind the stenotic lesions 107 in the target vessel 105. As described in more detail below, the abrasive elements 140a-c may have selected configurations and relative dimensions along the distal portion of the drive shaft 136 to improve navigation in smaller vessels below the ankle or in the heart, while also achieving an efficient trajectory path for grinding the stenotic material 107 in those vessels. (In the example shown, the vessel diameter VD of the target vessel 105 is 3 mm or less, approximately 2.5 mm as shown, while the initial path through the stenotic lesion is significantly smaller than this value.) Alternatively, the abrasive elements 140 and the drive shaft 136 may have selected configurations and relative dimensions (e.g., Figures 2-3 (8-15 and 17-26), which advantageously provides advance of a small percutaneous introducer 108 (e.g., sized to slidably receive an instrument with a diameter of 4 French or smaller) through a percutaneous opening 109 in the patient's leg, and can further navigate through the stenotic lesion 107 in the small artery 105, such as an artery below the ankle (e.g., in the foot) or a coronary artery (e.g., in the left anterior descending coronary artery or the left circumflex coronary artery) before sweeping through a larger orbital path (during rotation of the drive shaft 136) to grind the stenotic material 107.

[0062] System 100 may also include a power adapter 120 and a fluid source 125 (e.g., a saline bag) connectable to actuator handle assembly 110, and actuator handle assembly 110 may house an electric motor 112 (configured to drive rotation of drive shaft 136) and a fluid pump 114 (configured to push fluid such as saline toward a distal portion of drive shaft 136). As described in more detail below, a controller 150 for activating the electric motor 112 and pump 114 (in response to input at user interface buttons 116 and 117a-c of handle assembly 110) may be contained within housing 122 of power adapter 120, such that it can be reused with subsequent handle assemblies after the first handle assembly 110 is discarded (disposable handle assembly). Alternatively, a controller 150A for operating the electric motor 112 and pump 114 may be contained within housing in handle assembly 110 (proximity to electric motor 112 and pump 114), and the entire handle assembly 110 may be discarded after a single use by the patient. In both options, the clinician can operate the handle assembly 110 with a simplified screenless interface to perform and control the rotary cutting procedure (e.g., without a graphic display along the handle assembly or on a separate unit attached to the handle assembly).

[0063] Still referencing Figure 1 The elongated flexible drive shaft assembly 130 includes a sheath 132 extending over a large portion of the length of the flexible drive shaft 136, such that the abrasive elements 140a-c on the distal portion of the drive shaft 136 are distally located at the distal end of the sheath 132. The proximal end of the sheath 132 is secured to the distal end of the handle assembly 110. The flexible drive shaft 136 is slidably and rotatably disposed within a cavity of the sheath 132. The flexible drive shaft 136 defines a longitudinal cavity in which a guidewire 134 is slidably disposed. The guidewire 134 can extend through the handle assembly 110, the sheath 132, and the drive shaft 136, such that the proximal end of the guidewire 134 protrudes proximally from the rear port of the guidewire brake 118 at the proximal end of the handle assembly 110, while the distal end of the guidewire 134 extends distally to the distal end of the drive shaft 136. In this embodiment, the flexible drive shaft 136 includes a torque transmission coil of one or more helically wound filaments defining a longitudinal cavity along a central longitudinal axis. The drive shaft 136 is configured to rotate about the longitudinal axis while the sheath 132 remains substantially stationary. Thus, during the rotary cutting procedure, the sheath 132 and the guidewire 134 are substantially fixed, while the flexible drive shaft 136 can be controllably moved (e.g., rotated about the longitudinal axis and periodically translated proximally and / or distally longitudinally).

[0064] In the depicted embodiment, the exposed distal portion of the drive shaft 136 includes one or more grinding elements 140a-c, an optional distal stabilizing element 142, and an optional concentric end member 144 (see reference). Figure 6 In the depicted embodiment, one or more grinding elements include a set of three eccentric grinding elements 140a-c, which are fixedly mounted outside the torque transmission coil of the drive shaft 136 such that the center of mass of each grinding element 140a-c is offset from the central longitudinal axis of the torque transmission coil. In this embodiment, a distal stabilizing element 142 is concentrically fixed to the outside of the torque transmission coil of the drive shaft 136 between the most distal one of the eccentric grinding elements 140a-c and a concentric end member 144. Thus, the center of mass of the distal stabilizing element 142 is aligned with the central axis of the drive shaft 136, while the center of mass of each grinding element 140a-c is offset from the central axis of the drive shaft 136. (Concentric end member 144 - see reference) Figure 6 It is fixed to the distal end of the torque transmission coil and extends distally therefrom. As described in more detail below, the concentric distal member 144 has a smoother surface than the abrasive surfaces of the distal stabilizing element 142 and the eccentric abrasive elements 140a-c, and the concentric distal member 144 can be configured to provide initial penetration (and optionally, dilation) through the stenotic lesion 107 in the target vessel 105.

[0065] Still referencing Figure 1 When the drive shaft 136 rotates about its longitudinal axis, the eccentric grinding elements 140a-c (and the portion of the drive shaft 136 to which one or more grinding elements 140a-c are fixed) will be pushed in the track path relative to the central axis of the drive shaft 136 (also as described below, for example, in combination with...) Figure 5 Typically, a faster rotational speed (rpm) of the drive shaft 136 will result in a larger diameter track (within the limitations of the vessel diameter). One or more abrasive elements 140a-c moving along the track will contact the stenotic lesion 107 to grind the lesion to a reduced size using each traverse path through the lesion 107 (i.e., small particles of the lesion will be ground away from the lesion). Depending on the rotational speed and the surrounding environment within the vessel 105, the distal stabilizing element 142 can be rotated to remain approximately closer to or at the longitudinal axis of the drive shaft 136 during the abrasive procedure. In some alternative embodiments, two or more distal stabilizing elements 140 are included. As further described below, simultaneously with the rotation of the drive shaft 136, the drive shaft 136 can be translated back and forth (distal and proximal) along the longitudinal axis of the drive shaft 136. Thus, by means of the simultaneous translation of the abrasive elements 140a-c and the rotation of the track, the stenotic lesion 107 can be ground radially and longitudinally.

[0066] Additionally, the torque transmission coil of the flexible drive shaft 136 is laterally flexible, allowing the drive shaft 136 to easily advance through tortuous arterial paths (e.g., in the foot arterial ring or in coronary artery branches), and allowing a portion of the drive shaft 136 at and near one or more grinding elements 140 to be laterally deflected when subjected to centrifugal forces generated by the rotation of one or more eccentric grinding elements 140. In the depicted embodiment, the drive shaft 136 comprises one or more helically wound wires (or filaments) providing a uniform coil diameter smaller than the diameter of all grinding elements 140a-c and the distal stabilizing element 142. As described in more detail below, this relative dimension is referred to as the drill-to-coil diameter ratio, and for all grinding drills (elements 140a-c and distal stabilizing element 142) along the torque transmission coil of the drive shaft, the drill-to-coil diameter ratio may be approximately 1.3-1.7. Thus, the torque transmission coil of the flexible drive shaft 136 can achieve sufficient lateral flexibility during navigation through tortuous paths (e.g., in a patient's foot or heart) and sufficient longitudinal rigidity to be propelled through stenotic lesions in small arteries (while transmitting torque to rotate grinding elements 140a-c). In some embodiments, one or more helically wound wires (filaments) of the torque transmission coil of the flexible drive shaft 136 comprise metallic materials such as, but not limited to, stainless steel (e.g., 316, 316L, or 316LVM), nitinol, titanium, titanium alloys (e.g., titanium beta 3), carbon steel, or another suitable metal or metal alloy. Any suitable number of individual filaments can be included to construct the drive shaft 136. For example, in some embodiments, one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, or more than fifteen individual filaments can be helically wound around each other to form the drive shaft 136. As further described below, the direction of the filament winding of the drive shaft 136 is a design feature that can be selected to obtain desired, advantageous operating characteristics. For example, the drive shaft 136 can be formed using one or more filaments wound on the central axis of the shaft in a winding direction opposite to the direction of rotation of the drive shaft 136 pushed by the handle assembly 110. This can provide many benefits and improve safety when using the drive shaft 136 and guidewire 134 in small arteries below the ankle or in the heart.

[0067] Still referencing Figure 1In this embodiment, the torque transmission coil of the drive shaft 136 defines a hollow central core (e.g., a central cavity referred to as the drive shaft 136) in which the guidewire 134 can be slidably received. In some embodiments, the cavity can be used to aspirate particles or deliver fluids beneficial to the resection procedure. In use, the guidewire 134 is advanced to the target vessel 105, and then the drive shaft 136 is advanced over the guidewire 134 to reach the target vessel 105. The guidewire 134 has a length sufficient to extend through the entire drive shaft 136 and the entire handle assembly 110. Thus, the proximal end of the guidewire 134 protrudes proximally from the rear port of the guidewire brake 118 at the proximal end of the handle assembly 110, while the distal end of the guidewire 134 extends distally to the most distal end of the drive shaft 136.

[0068] In the depicted embodiment, the concentric distal member 144 is welded or otherwise secured to the distal end of the torque transmission coil of the drive shaft 136 (e.g., the axial distal side of the coil), and the distal stabilizing element 142 is welded or otherwise secured to the distal end of the torque transmission coil of the drive shaft 136 (e.g., the radially outer side of the coil). As described in more detail below, the smooth initial surface of the concentric distal member 144 and the subsequently polished surface on the distal stabilizing element 142 can facilitate initial dilation and polishing of the guide path through the stenotic lesion 107 in the target vessel 105.

[0069] Still referencing Figure 1 One or more abrasive elements 140a-c (each of which may also be referred to as an abrasive drill) may comprise a biocompatible material coated with an abrasive medium such as diamond grit, diamond particles, silicon carbide, etc. In the depicted embodiment, the abrasive element 140a-c comprises a total of three discrete abrasive spheres / cylinders spaced apart from each other (and spaced apart relative to the distal stabilizing element 142) to facilitate navigation to and orbital abrasion within the target arteriole, including those with a vessel diameter typically 3 mm or less and an entry path following a tortuous route. In the depicted embodiment, all three abrasive elements 140a-c are spheres of the same diameter and are mounted in an eccentric helical arrangement (see below). Figures 2-3 Description). Other embodiments described herein (e.g., refer to...) Figures 9-24 ) can also be based on Figure 1The system 100 is used to facilitate navigation to and orbital grinding within target arterioles, including those with an inner diameter typically of 3 mm or less and whose access path follows a tortuous route. Similar to the distal stabilizing element 142, the grinding drills 140a-c can be mounted externally to the torque transmission coil of the drive shaft 136 using biocompatible adhesives, high-temperature solder, welding, press fitting, etc. Alternatively, one or more grinding elements 140a-c can be integrally formed with the filament of the drive shaft 136 as a single structure (e.g., using filaments wound in different patterns to create an axial offset structure, etc.).

[0070] Still referencing Figure 1 The rotary cutting system 100 also includes an actuator handle assembly 110. The actuator handle assembly 110 includes a housing 111 and an internal bracket assembly (not shown) that translates along an actuator slot 113. For example, a user can grasp the actuator 116 to actuate movement along the actuator slot 113, which allows the internal bracket assembly to slidably translate along the longitudinal axis of the handle assembly 110, as indicated by arrow 115. In some embodiments, the bracket assembly can translate, but is not limited to, about 8 cm to about 12 cm, or about 6 cm to about 10 cm, or about 4 cm to about 8 cm, or about 6 cm to about 14 cm. As the bracket assembly translates relative to the housing 111, the drive shaft 136 translates correspondingly relative to the sheath 132. This allows the user to reciprocate the distal portion of the drive shaft 136 relative to the stenotic lesion 107 within the target vessel 105 in both distal and proximal directions.

[0071] Handle assembly 110 has a cable connection 121 to a power adapter 120 (configured to receive power from a power source 128 such as a wall plug) and a fluid line connection 126 to a brine source 125. Cable 121 can transmit both power and data (e.g., when controller 150 is housed within power adapter housing 122), or alternatively, can transmit power (e.g., when implementing a version utilizing controller 150A housed within handle housing 111). Cable 121 includes a removable connection socket, allowing handle assembly 110 to be easily discarded after a single use, and power adapter 120 to be reused with subsequent handle assemblies. Fluid line connection 126 may include a Luer connector and a flow switch valve, allowing a user to removably connect the handle assembly to a rod-mounted brine bag or other fluid source 125 without requiring an external pump mechanism positioned outside handle housing 111.

[0072] Still referencing Figure 1The actuator 116 of the handle assembly 110 includes a rotary power button that activates an electric motor 112 (carried by an internal bracket assembly) to drive the rotation of the drive shaft 136. For example, when the rotary power button of the actuator 116 is pressed, power is supplied to the electric motor 112, which is coupled to the drive shaft 136 via a set of gears. It should be understood that the rotary cutting system 100 is configured to rotate the drive shaft 136 at a high speed (e.g., 20,000-160,000 rpm), causing one or more eccentric abrasive elements 140a-c to rotate in a track path to thereby contact and remove portions of the target lesion 107 (even those portions of lesions that are further from the axis of the drive shaft 136 than the maximum radius of the abrasive elements 140a-c).

[0073] To operate the handle assembly 110 during the rotary excision procedure, the clinician can grasp the actuator 116 and press the rotary power button (on the actuator 116) with the same hand. The clinician can move (translate) the actuator 116 distally and proximally (e.g., back and forth relative to the housing 111) along the slot 113 while holding the rotary power button of the actuator 116 in the pressed position. In this way, the target lesion 107 can be radially and longitudinally ground by means of the orbital rotation and translation generated by the abrasive elements 140a-c.

[0074] To further manipulate the handle assembly 110 during the rotary cutting procedure, the clinician can select the rotation speed using electrical switches 117a and 117b. In some cases, the rotation speed can be selected via a set of predefined speeds (e.g., at least two predefined speed settings, such as "low" and "high"), where electrical switch 117a causes an increase in the speed setting and electrical switch 117b causes a decrease in the speed setting. Optionally, each of the electrical switches 117a-b may also include a light indicator. For example, when electrical switches 117a-b allow selection of "high" and "low" speeds respectively, each electrical switch 117a-b may have a single lamp such that when a speed is selected, the lamp corresponding to the selected electrical switch 117a or 117b is illuminated to notify the clinician of the selected speed. In some embodiments, light can be emitted through electrical switches 117a and 117b. Alternatively, the lamp may be positioned proximal to the electrical switches 117a-b. As another example, when the electrical switch 117a-b allows the speed to be modified within a speed range, the light indicator can be a light bar such that the number of lights illuminated on the light bar corresponds to the selected speed.

[0075] Still referencing Figure 1The handle assembly 110 may include a fluid pump switch 117c, which can activate an internal fluid pump 114 to draw fluid (e.g., saline in this embodiment) from the fluid line 126 and push the fluid toward the distal portion of the drive shaft 136 through the sheath 132. Thus, the fluid pump switch 117c can be used to initially perfuse the sheath 132 (and remove air before insertion into the patient) and then selectively activate additional flushing fluid through the sheath 132 and into the blood vessel 105. In some cases, a first press of the fluid pump switch 117c will turn on the internal pump 114, and a second press will turn off the pump 114. In some embodiments, the fluid pump switch 117c includes a light indicator such that a light is illuminated when the pump is turned on to notify the clinician that the pump is on.

[0076] In the described embodiment, the handle assembly 110 also includes a guidewire brake 118, which can be selectively actuated (e.g., pivoted relative to the handle housing 111 in this embodiment) to releasably clamp the guidewire 134 in a fixed position relative to the handle assembly 110 (and subsequently, rotationally fixed relative to the drive shaft 136 during the resection treatment). When the drive shaft 136 and handle assembly 110 advance over the guidewire 134 to place one or more abrasive elements 140 at a target location within the patient's blood vessel, the guidewire brake 118 is in a non-activated state (e.g., pivoted counterclockwise about the central guidewire axis from a posterior view), allowing the handle assembly 110 to slide freely relative to the guidewire 134. Then, when the clinician is ready to begin the resection treatment, the guidewire brake 118 can be activated (e.g., pivoted clockwise about the central guidewire axis) to mechanically engage the exterior of the guidewire 134 and thereby releasably retain / lock the guidewire 134 relative to the handle assembly 110. Thus, when the drive shaft 136 rotates, the guide wire 134 will not rotate, and when the actuator 116 is manually translated in direction 115, the guide wire 134 will not translate.

[0077] Still referencing Figure 1The handle assembly 110 may include a wire brake light 119 positioned along the upper surface of the handle housing 111, proximal to and adjacent to the other user interface buttons 117a-c. This allows the user to easily observe the wire brake light 119 and receive confirmation that the wire brake 118 is fully engaged (to clamp the wire 134) before selecting the rotation speed (e.g., buttons 117a-b) and initiating rotation (e.g., a button on actuator 116). Therefore, the screenless user interface of the handle assembly 110 provides the user with simplified and smooth hand movements while also conveying useful information. Optionally, controller 150 (or 150A in other embodiments) may be configured to prevent electric motor 112 from driving rotation of drive shaft 136 until: (1) guidewire brake 118 is activated (e.g., guidewire brake light 119 is illuminated), (2) pump 114 is activated to drive flushing fluid (e.g., via actuation of fluid pump switch 117c, then illuminating button 117c), (3) rotation speed has been selected via speed selection switches 117a and 117b (e.g., speed indicator lights thereon are activated), or a combination of all these conditions. As another example, indicator lights associated with selection switches 117a and 117b, fluid pump switch 117c, and guidewire brake light 119 will warn clinicians not to operate rotary cutting system 100 until all three systems (motor, pump, guidewire brake) are activated. For example, each system may have a green light, such that three green lights indicate to clinicians that rotary cutting can continue. Optionally, only actuation of guidewire 118 is required to allow rotation of rotary cutting system 100.

[0078] Still referencing Figure 1The rotary cutting system 100 also includes a controller 150, which in this embodiment includes a processor and a computer-readable storage device thereon storing control instructions. The controller 150 is configured to receive input from sensors housed within the handle assembly, input from a user interface (e.g., switches / actuators 116, 117a-c and 118) on the handle assembly 110, and control the activation of the electric motor 112 and the pump 114 (in response to input at the user interface switches / actuators). In this embodiment, the controller 150 is contained within a housing 122 of the power adapter 120, such that the controller 150 can be reused with subsequent handle assemblies after the first handle assembly 110 has been discarded (e.g., after use on the first patient). As previously described, the cable 121 can provide data communication between the controller 150 and components of the user interface (e.g., switches / actuators 116, 117a-c and 118), the electric motor 112, the pump 114, and the feedback sensors housed within the handle assembly 110. In an alternative embodiment, the controller (including a processor and a computer-readable storage device for storing control instructions) may be provided as a controller 150A configured to be contained within the housing 111 of the handle assembly 110 (near the electric motor 112 and pump 114). In both options, the handle assembly 110 can be operated by a clinician using the simplified screenless interface described above for controlled percutaneous cutting procedures (e.g., without a user interface display along the handle assembly or on the unit attached to the handle assembly). Preferably, the controller 150 (or controller 150A) is contained in a sealed manner to the fluid (e.g., saline, blood, or others) encountered by the handle assembly.

[0079] Now for reference Figures 2-3 Some embodiments of the distal portion of the drive shaft 136 include an improved configuration of an abrasive drill (and optionally a distal stabilizing element) that provides relative orientation, relative spacing, and relative size along the torque transmission coil 137 of the drive shaft 136 to achieve an effective access path to such small arteries, including those with a vessel diameter typically 3 mm or less and whose access path follows a tortuous route. In the depicted embodiments, the abrasive elements 140a-c are eccentrically fixed to the torque transmission coil 137 of the drive shaft 136, while the distal stabilizing element 142 (having a similar abrasive surface) is concentric with the torque transmission coil 137 of the drive shaft 136. Figure 2As shown, the torque transmission coil 137 has a coil diameter A, and all grinding drills 140a-c have the same diameter G (which is larger than the coil diameter). For example, the grinding drills 140a-c may have a diameter G of 1.0 mm to 1.33 mm, preferably 1.1 mm to 1.3 mm, and in the embodiment depicted herein, it is 1.25 mm (e.g., a nominal diameter of 1.25 mm before the application of a thin abrasive coating). Furthermore, in such an example, the coil diameter A may be 0.7 mm to 0.9 mm, and preferably 0.8 mm in the depicted embodiment. Therefore, in some embodiments described herein, the relative size ratio (e.g., drill to coil diameter ratio) between the diameter G and the coil diameter A of each grinding element 140a-c is 1.7 or less. In some embodiments, the drill to coil diameter ratio may be about 1.3-1.7 for all grinding elements along the torque transmission coil of the drive shaft. In the depicted example, for each eccentric grinding element 140a-c mounted to the torque transmission coil 137, the drill-to-coil diameter ratio may be 1.5-1.6, and for the distal stabilizing element 142 mounted to the torque transmission coil 137, the drill-to-coil diameter ratio may be 1.3-1.4.

[0080] Similarly, Figure 3 As shown, the centroids of the grinding drills 140a-c are offset in different planes by a radial spacing angle H. For example, the radial spacing angle H is from 5 degrees to 87.5 degrees, preferably from 20 degrees to 60 degrees, and is 37.5 degrees in the embodiment depicted herein. Thus, the combined radial angle of all the grinding drills 140a-c along a specific length of the drive shaft carrying the grinding drills 140a-c is less than 175 degrees (e.g., less than 120 degrees, and preferably less than 90 degrees in the depicted embodiment).

[0081] Still referencing Figures 2-3The abrasive drills 140a-c can be mounted to the coil 137 to provide a compact end length E between the proximal abrasive element 140a and the distal end of the drive shaft 136. This can effectively treat stenotic lesions 107 in small arteries, such as those in the foot below the ankle or in the coronary arteries. For example, the compact end length E can be 5 cm or less from the distal end of the drive shaft 136, preferably 2 cm or less, and approximately 1.9 cm (0.75 inches) in the depicted embodiment. This end length E can be relatively compact compared to the total length B of the torque transmission coil 137. For example, in the depicted embodiment, the total length B can be 150 cm to 250 cm, 110 cm to 200 cm, and approximately 197 cm (77.5 inches). Therefore, the end length E can be less than 1% of the total length B. In some embodiments, the ratio of the total length B to the end length E is greater than 50:1, ranging from about 90:1 to 140:1, and is about 103:1 in the depicted embodiment. Furthermore, in the depicted embodiment, the abrasive drills 140a-c within the compact end length E comprise a total of three discrete elements spaced apart from each other. In other embodiments, one, two, three, four, or five discrete abrasive elements are included in a group of abrasive elements within the compact end length E.

[0082] Additionally, within the compact end length E of the drive shaft 136, the relative spacing of the grinding drills 140a-c can advantageously influence the trajectory path of the grinding elements, the flexibility of the middle portion of the torque transmission coil (which is useful during advancement through a tortuous arterial path), or both. For example, the furthest grinding drill 140c may be spaced apart from the furthest end of the shaft by an extension length C, the next grinding drill 140b by a drill spacing distance D, and the nearest grinding drill 140a by the same drill spacing distance D. In the depicted embodiment, the extension length C is greater than the drill spacing distance D, but in other embodiments they may be approximately equal (e.g., see reference...). Figures 21-24 For example, in the depicted embodiments, the extension length C can be 4 mm to 15 mm, 5 mm to 10 mm, and about 9 mm (0.35 inches), while in the depicted embodiments, the drill spacing distance D can be 2 mm to 7 mm, 4 mm to 6 mm, and about 5 mm (0.20 inches).

[0083] Still referencing Figures 2-3 Some embodiments of the abrasive drill 140a-c, the optional distal stabilizing element 142, and the optional distal end member 144 may provide relative orientation, relative spacing, and relative size along the torque transmission coil 137 to advantageously advance through a relatively small percutaneous entry point, such as an entry point in the patient's thigh with a small introducer sheath (e.g., refer to the above).Figure 1 The device then proceeds to the patient's foot or heart to remove (completely or partially) the narrowing material from the target artery. As described above, Figures 2-3 The embodiments depicted are provided in the form of a “4-French-introducible” device.

[0084] Now for reference Figure 4 The filament winding direction 138 (e.g., the winding direction of the filament of the torque transmission coil 137 traversing from distal to proximal) and the rotation direction 139 of the torque transmission coil 137 (e.g., the rotation direction of the drive shaft 136 actuated by the handle assembly 110) can be configured to provide numerous performance benefits during rotary cutting in foot or coronary arteries, especially those where the vessel diameter is typically 3 mm or less and the entry path follows a tortuous route. For example, as Figure 4 (as well as Figures 2 to 3 As shown, the filament winding direction 138 is opposite to the rotation direction 139 of the torque transmission coil 137. This can provide functional benefits when advancing into tight lesions in small arteries within the foot (below the ankle) or entering branch coronary arteries (e.g., the left anterior descending coronary artery or the left circumflex coronary artery) via a tortuous path. In particular, during rotation of the drive shaft 136 adjacent to this lesion, one of the grinding elements 140a-c, the distal stabilizing element 142, or the distal end 144 may become stuck in body material or may otherwise be temporarily restricted in rotation (even via the handle assembly 110). Figure 1 (The near end of the rotary drive shaft 136). In this case, the filament winding direction 138 is opposite to the rotation direction 139 of the torque transmission coil 137, as shown. Figures 2 to 3 As shown, the torque transmission coil 137 will not suffer from a narrowed coil diameter that would cause the torque transmission coil 137 to clamp onto the guidewire 134 (e.g., resulting in reduced flexibility and potential other problems in the narrow space of the blood vessel), but the coil diameter will remain the same or temporarily enlarged (safely avoiding clamping of the guidewire 134).

[0085] Therefore, the drive shaft 136 of the rotary cutting system 100 can be configured to provide safe and repeatable navigation to smaller blood vessels below the ankle or in the heart, as well as an efficient track path for grinding narrowing material in such smaller blood vessels. This configuration can be particularly useful, for example, when implemented as a foot artery ring navigation device, a coronary artery branch navigation device, or both.

[0086] Now for reference Figure 5 The drive shaft 136 of the rotary cutting device can be equipped with a concentric end member 144 and a distal stabilizing element 142 in an arrangement covering the farthest end of the torque transmission coil 137. Therefore, the stenotic lesion 107 ( Figure 4Before engaging the outside of the torque transmission coil 137, it is first engaged with the concentric end member 144 and the distal stabilizing element 142. In this embodiment, the distal end member is welded (e.g., butt welded) or otherwise secured to the distal end of the torque transmission coil 137 of the drive shaft 136, such that the entire distal end member 144 is positioned axially distal to the torque transmission coil 137. Furthermore, in this embodiment, the distal stabilizing element 142 is a cylindrical structure that is welded or otherwise secured to the distal end of the torque transmission coil 137, such that the distal stabilizing element 142 is positioned radially outward of the coil diameter. Thus, the distal end of the torque transmission coil of the drive shaft 136 is concealed by the distal stabilizing element 142 and the concentric end member 144. In this embodiment, both the distal stabilizing element 142 and the concentric end member 144 comprise cylindrical metal members axially aligned with the central axis of the drive shaft 136, but they differ in size and grindability. The distal stabilizing element 142 has an inner diameter surrounding the outer coil diameter of the drive shaft 136 (and therefore the maximum outer diameter of the distal stabilizing element 142 is greater than the coil diameter), and the concentric end member 144 has an outer diameter substantially the same as the coil diameter. Furthermore, the distal stabilizing element 142 has an abrasive outer coating. For example, in some embodiments, a diamond coating (or other suitable type of abrasive coating) is provided on the outer surface of the distal stabilizing element 142. In this embodiment, the concentric end member 144 has a smooth outer surface that is less abrasive than the outer surface of the distal stabilizing element 142. In some cases, the smooth initial surface of the concentric end member 144, and subsequently the abrasive surface on the distal stabilizing element 142, can help facilitate the initial dilation and abrasive guidance path through the stenotic lesion 107 in the target vessel 105. Both the distal stabilizing element 142 and the concentric end member 144 may comprise biocompatible materials, such as high-density biocompatible materials. For example, in some embodiments, each of the distal stabilizing element 140 and the concentric end member 144 may comprise a metallic material, such as stainless steel, tungsten, molybdenum, iridium, cobalt, cadmium, etc., and alloys thereof. Furthermore, in this embodiment, the distal stabilizing element 140 and the concentric end member 144 have a fixed outer diameter. That is, in the depicted embodiment, the distal stabilizing element 140 and the concentric end member 144 are not expandable members.

[0087] Now for reference Figures 6-7Some embodiments of the rotary cutting system 100 can (partially or completely) remove one or more stenotic lesions in a target foot artery below the ankle. For example, in the depicted embodiment, the drive shaft 136 of the rotary cutting system 100 is navigated toward the foot arterial ring (LP) via the anterior tibial (AT) artery into the dorsalis pedis (DP) artery. As previously described, components along the distal portion of the drive shaft 136 may have orientation, relative spacing, and relative dimensions to achieve an effective access path to such small arteries, including those with a vessel diameter typically 3 mm or less and an access path following a tortuous route. In use, the system 100 includes a guidewire 134, which is advanced into the target foot artery below the ankle. Figures 6-7 In the example shown, guidewire 134 is navigated through the anterior tibial (AT) artery into the dorsalis pedis (DP) artery and into the foot arterial ring (LP). Such guidewire placement can be used for targeted cutting of one or more lesions in the dorsalis pedis (DP). It should be understood from the description herein that the target foot artery may additionally or alternatively include the foot arterial ring (LP), the anterior tibial (AT) artery below the ankle, the posterior tibial (PT) artery below the ankle, the common plantar (CP) artery, and the medial plantar (MP) artery. After the guidewire 134 advances, drive shaft 136 engages with sheath 132 ( Figure 1 The guidewire 134 is advanced at its proximal end, such that the proximal end of the guidewire 134 passes through the entire drive shaft 136 and the handle assembly 110. Figure 1 The drive shaft 136 and sheath 132 advance through a relatively small introducer sheath in the patient's leg, such as a 4 French introducer sheath. Figure 1 ).

[0088] Still referencing Figures 6-7 When the distal portion of the drive shaft 136 is navigated toward the target foot artery (preferably, under medical imaging), the concentric distal member 144 (followed by the abrasive surface on the distal stabilizing element 142) can be used to initially form a guide path through the stenotic lesion in the foot artery. From there, the user can select a rotation speed setting (e.g., using user interface buttons 117a-b on the handle assembly) so that the abrasive elements 140a-c can abrade the stenotic material and achieve a trajectory path during rotation (e.g., a trajectory path larger than the maximum resting diameter of the abrasive elements 140a-c). Handle assembly 110 ( Figure 1 The abrasive element 140a-c can be translated by reciprocating motion (distal and proximal) during high-speed rotation of the abrasive element 140a-c in the track path via actuator 116 to pass through the stenotic lesion in the foot artery multiple times.

[0089] Therefore, the drive shaft 136 of the rotary cutting system 100 can be configured to provide safe and repeatable navigation to smaller blood vessels below the ankle or in the heart, as well as an efficient track path for grinding narrowing material in such smaller blood vessels. This configuration can be particularly useful when the rotary cutting system 100 is implemented as a foot arterial ring navigation system, for example, as... Figures 2-7 As shown in the image. Additionally... Figures 2-7 The implementation of the drive shaft depicted is also effective for removing or reducing stenotic lesions in larger blood vessels (e.g., blood vessels in the leg above the ankle), thus providing users with the option to effectively treat various arterial sites during a single procedure using a single drive shaft 136.

[0090] Now for reference Figures 8-9 Some embodiments of the distal portion of the drive shaft 136 include an alternative configuration of a grinding drill, which also provides relative orientation, relative spacing, and relative size of the torque transmission coils 137 along the drive shaft 136 to achieve an effective access path to such small arteries, including those with a vessel diameter typically 3 mm or less and whose access path follows a tortuous route. In the depicted embodiments, the components along the distal portion of the drive shaft 136 are similar to those of a combination Figures 2-3 The described components, except that the distal and proximal grinding elements 140d have smaller dimensions than the intermediate grinding element 140b. For example, the torque transmission coil 137, filament winding direction 138, rotation direction 139, intermediate grinding element 140b, optional distal stabilizing element 142, and optional distal end member 144 have features previously combined... Figures 2-3 A similar configuration is described here. Figures 8-9 As shown, a set of grinding drills along the end length of the torque transmission coil 137 includes distal and proximal grinding drills 140d, which have a smaller size than the intermediate grinding drill 140b. Figure 8 As shown, the distal and proximal grinding drills 140d have a diameter G1, and the intermediate grinding drill 140b has a larger diameter G2 (both G1 and G2 are larger than the combined diameter). Figure 2The described coil diameter A). For example, the distal and proximal grinding drills 140d can have a diameter G1 of 1.0 mm to 1.15 mm, and particularly 1.1 mm in the embodiment depicted herein (e.g., a nominal diameter of 1.1 mm before applying the thin grinding coating), and the intermediate grinding drill 140b can have a diameter G2 of 1.2 mm to 1.33 mm, and particularly 1.25 mm in the embodiment depicted herein (e.g., a nominal diameter of 1.25 mm before applying the thin grinding coating). As previously mentioned, in such an example, the coil diameter A can be 0.7 mm to 0.9 mm, and preferably 0.8 mm in the depicted embodiment. Thus, in the depicted example, for each smaller grinding drill 140d mounted to the torque transmission coil 137, the drill-to-coil diameter ratio can be 1.3-1.4, and for the larger grinding drill 140b mounted to the torque transmission coil 137, the drill-to-coil diameter ratio can be 1.5-1.7. Similarly, as... Figure 9 As shown, the centroids of the distal grinding drill 140d, the intermediate grinding drill 140b, and the proximal grinding drill 140d are offset in different planes at a radial interval of angle H. (As previously stated...) Figures 2-3 The radial spacing angle H is 5 degrees to 87.5 degrees, preferably 20 degrees to 60 degrees, and is 37.5 degrees in the embodiment depicted herein. Thus, the combined radial angle of all grinding drills 140d, 140b and 140d is less than 175 degrees along the end length of the drive shaft (e.g., less than 120 degrees, and preferably less than 90 degrees in the depicted embodiment).

[0091] Therefore, similar to the combination above Figures 2-4 The described embodiments, Figures 8-9 The embodiments depicted are provided in the form of a "4-French-introducible" device as described above. Additionally, Figure 1 The grinding drills 140d, 140b, and 140d shown, the optional distal stabilizing element 142, and the optional distal end member 144 can collectively provide relative orientation, relative spacing, and relative size along the torque transmission coil 137 to advantageously advance through relatively small percutaneous entry points, such as those in the patient's thigh with small inserter sheaths (e.g., refer to above). Figures 10-11 This is used to subsequently advance into the patient's foot or heart to remove (completely or partially) the narrowing material from the target artery.

[0092] Now for reference Figures 8-9Additional embodiments of the distal portion of the drive shaft 136 include an alternative configuration of a grinding drill, which also provides relative orientation, relative spacing, and relative size of the torque transmission coils 137 along the drive shaft 136 to achieve an effective access path to such small arteries, including those with a vessel diameter typically 3 mm or less and whose access path follows a tortuous route. In the depicted embodiments, the components along the distal portion of the drive shaft 136 are similar to those of a combined... Figures 2-3 The described components, except that the distal and proximal grinding elements 140e have different cutouts for mounting to the torque transmission coil 137, such that the geometric center of the spherical element is axially aligned with the axis 135 of the torque transmission coil 137. For example, the torque transmission coil 137, the filament winding direction 138, the rotation direction 139, the intermediate grinding element 140b, the optional distal stabilizing element 142, and the optional distal end member 144 have features consistent with the previously combined... Figures 8-9 and Figures 10-11 A similar configuration as described. Here, as... Figures 8-9 As shown, the distal and proximal grinding drills 140e have deeper mounting slots formed therein (e.g., with...). Figures 8-9 The exemplary grinding element 140d is deeper than the others, such that when the distal and proximal grinding drills 140e are fixed to the outside of the torque transmission coil 137, the geometric center of each spherical element 140e is axially aligned with the axis 135 of the torque transmission coil 137. In other words, even when the distal and proximal grinding drills 140d ( Figures 10-11 ) and distal and proximal grinding drills 140e ( Figures 10-11 ) with the same diameter size, distal and proximal grinding drill 140e ( Figure 11 The outer spherical surface of the torque transmission coil 137 is closer to the central axis 135. Due to the mounting slots formed in each of the distal and proximal grinding drills 140e, the centroid of the drill 140e is offset from the central axis, while the geometric center of the drill 140e is aligned with the axis. Moreover, as Figures 2-3 As shown, the centroids of the distal grinding drill 140e, the intermediate grinding drill 140b, and the proximal grinding drill 140e are offset in different planes by a radial interval angle H. (As previously stated...) Figures 2-4 As described in 8-9, the radial spacing angle H is from 5 degrees to 87.5 degrees, preferably from 20 degrees to 60 degrees, and is 37.5 degrees in the embodiment depicted herein. Thus, the combined radial angle of all grinding drills 140e, 140b and 140e is less than 175 degrees along the end length of the drive shaft (e.g., less than 120 degrees, and preferably less than 90 degrees in the depicted embodiment).

[0093] Here again, similar to the combination above... Figures 10-11 And the embodiments described in 8-9, Figures 10-11The embodiments depicted are provided in the form of a "4-French-introducible" device, as described above. Additionally, Figure 1 The grinding drills 140e, 140b, and 140e shown, the optional distal stabilizing element 142, and the optional distal end member 144 can collectively provide relative orientation, relative spacing, and relative size along the torque transmission coil 137 to advantageously advance through relatively small percutaneous entry points, such as those in the patient's thigh with small inserter sheaths (e.g., refer to above). Figures 12-13 This is used to subsequently advance into the patient's foot or heart to remove (completely or partially) the narrowing material from the target artery.

[0094] Now for reference Figures 8-9 Additional embodiments of the distal portion of the drive shaft 136 include an alternative configuration of a grinding drill, which also provides relative orientation, relative spacing, and relative size of the torque transmission coils 137 along the drive shaft 136 to achieve an effective access path to such small arteries, including those with a vessel diameter typically 3 mm or less and whose access path follows a tortuous route. In the depicted embodiments, the components along the distal portion of the drive shaft 136 are similar to those of a combined... Figures 2-3 The described components, except that one of the distal and proximal grinding elements (distal grinding element 140f in this example) has a centroid offset in the same plane as the intermediate grinding element 140b. For example, the torque transmission coil 137, filament winding direction 138, rotation direction 139, intermediate grinding element 140b, optional distal stabilizing element 142, and optional distal end member 144 have features consistent with the previously combined... Figures 8-9 and Figures 8-9 A similar configuration as described. And, similar to... Figure 8 In the embodiment shown, the distal grinding drill 140e and the proximal grinding drill 140d have the same diameter (e.g., as shown above). Figure 8 The diameter dimension G1 described in the text is smaller than that of the intermediate grinding drill 140b (e.g., the one above). Figures 12-13 The diameter dimension G2 described in [the text]. However, as [the text continues with details about diameter dimensions and diameter]. Figures 2-3 As shown, the grinding drills are offset only in two longitudinal planes. For example, only one of the grinding drills (element 140d in this example) has a centroid offset radially at an angle H in different planes, while the remaining grinding drills 140f and 140b have centroids offset in the same longitudinal plane. As previously combined Figures 2-4 As described in 8-9, the radial spacing angle H is from 5 degrees to 87.5 degrees, preferably from 20 degrees to 60 degrees, and is 37.5 degrees in the embodiment depicted herein. Thus, the combined radial angle of all grinding drills 140e, 140b and 140e is less than 175 degrees along the end length of the drive shaft (e.g., less than 120 degrees, and preferably less than 90 degrees in the depicted embodiment).

[0095] Therefore, similar to the combination above Figures 12-13 And the embodiments described in 8-11, Figures 12-13 The embodiments depicted are provided in the form of a "4-French-introducible" device, as described above. Additionally, Figure 1 The grinding drills 140f, 140b, and 140d shown, the optional distal stabilizing element 142, and the optional distal end member 144 can collectively provide relative orientation, relative spacing, and relative size along the torque transmission coil 137 to advantageously advance through relatively small percutaneous entry points, such as those in the patient's thigh with small inserter sheaths (e.g., refer to above). Figures 14-15 This is used to subsequently advance into the patient's foot or heart to remove (completely or partially) the narrowing material from the target artery.

[0096] Now for reference Figures 8-9 Other embodiments of the distal portion of the drive shaft 136 include alternative configurations of a grinding drill, which also provide a relative orientation, relative spacing, and relative size configuration of the torque transmission coils 137 along the drive shaft 136 to achieve an effective access path to such small arteries, including those where the vessel diameter is typically 3 mm or less and the access path follows a tortuous route. In the depicted embodiments, the components along the distal portion of the drive shaft 136 are similar to those of a combination... Figures 2-3 The described components, except for all distal and proximal grinding elements 140f and the intermediate grinding element, have centroids offset in the same plane. For example, the torque transmission coil 137, filament winding direction 138, rotation direction 139, intermediate grinding element 140b, optional distal stabilizing element 142, and optional distal end member 144 have features previously combined... Figures 8-9 and Figures 8-9 A similar configuration as described. And, similar to... Figure 8 In the embodiment shown, the distal grinding drill 140f and the proximal grinding drill 140f have the same diameter (e.g., as shown above). Figure 8 The diameter dimension G1 described in the text is smaller than that of the intermediate grinding drill 140b (e.g., the one above). Figures 14-15 The diameter dimension G2 described in [the text]. However, as [the text continues with details about diameter dimensions and diameter]. Figures 2-4 As shown, the grinding drill is offset only in a single longitudinal plane.

[0097] Here again, similar to the combination above... Figures 14-15 And the embodiments described in 8-13, Figures 14-15 The embodiments depicted are provided in the form of a "4-French-introducible" device, as described above. Additionally, Figure 1The grinding drills 140f, 140b, and 140f shown, the optional distal stabilizing element 142, and the optional distal end member 144 can collectively provide relative orientation, relative spacing, and relative size along the torque transmission coil 137 to advantageously advance through relatively small percutaneous entry points, such as those in the patient's thigh with small inserter sheaths (e.g., refer to above). Figure 16 This is used to subsequently advance into the patient's foot or heart to remove (completely or partially) the narrowing material from the target artery.

[0098] Now for reference Figures 14-15 Some embodiments of the rotary cutting system 100 can advance along a tortuous path into a branch coronary artery of the heart (e.g., the left anterior descending coronary artery or the left circumflex coronary artery) to (partially or completely) remove one or more stenotic lesions in the target branch coronary artery. For example, in the depicted embodiment, the drive shaft 136 of the rotary cutting system 100 navigates towards the left anterior descending artery (LAD) of the heart through the aorta into the left aorta (LMA). In the depicted embodiment, the distal portion of the drive shaft 136 includes... Figures 2-3 The configuration described herein, however, should be understood from the description herein to be that other embodiments can also be implemented in the target branch coronary artery (e.g., Figures 8-13 , Figures 17-24 and Figure 16 ).

[0099] As previously described, components along the distal portion of the drive shaft 136 can have orientations, relative spacing, and relative dimensions to achieve an effective access path to such small arteries, including those with a vessel diameter typically 3 mm or less and whose access path follows a tortuous route. In use, the system 100 includes a guidewire 134, which is advanced into a target branch of the heart, the coronary artery. Figure 1 In the example shown, guidewire 134 is navigated into the left aorta (LMA) via the left anterior descending artery (LAD) towards the heart. Such guidewire positioning can be used to target one or more lesions within the LAD. It should be understood from the description here that the target branch coronary artery may alternatively include the left circumflex artery (LCX) or other branch arteries along the heart. After the guidewire 134 is advanced, drive shaft 136 engages with sheath 132 ( Figure 1 The guidewire 134 is advanced at its proximal end, such that the proximal end of the guidewire 134 passes through the entire drive shaft 136 and the handle assembly 110. Figure 1 The drive shaft 136 and sheath 132 extend posteriorly from the proximal end of the handle assembly 110. Alternatively, the drive shaft 136 and sheath 132 advance through a relatively small inserter sheath in the patient's leg, such as a 4-French inserter sheath. Figure 16 ).

[0100] Still referencing Figure 1 When the distal portion of the drive shaft 136 is navigating toward the target branch coronary artery (preferably under medical imaging), the concentric distal member 144 (followed by the abrasive surface on the distal stabilizing element 142) can be used to initially form a guide path through the stenotic lesion in the branch coronary artery. From there, the user can select a rotation speed setting (e.g., using user interface buttons 117a-b on the handle assembly) so that the abrasive elements 140f, 140b, and 140f can abrade the stenotic material and achieve a trajectory path during rotation (e.g., a trajectory path larger than the maximum rest diameter of the larger abrasive element 140b). Handle assembly 110 ( Figures 2-7 The abrasive elements 140f, 140b, and 140f can be translated by reciprocating motion (distal and proximal) during high-speed rotation of the abrasive elements 140f, 140b, and 140f in the track path via actuator 116 to pass through the stenotic lesion in the foot artery multiple times.

[0101] Therefore, the drive shaft 136 of the rotary cutting system 100 can be configured to provide safe and repeatable navigation into smaller blood vessels below the ankle or in the heart, and an efficient track path for grinding narrowing material in these smaller blood vessels. This configuration can be particularly useful when the rotary cutting system 100 is implemented as a foot arterial ring navigation system, for example, as... Figures 2-7 As shown in the image. Additionally... Figures 17-18 The implementation of the drive shaft depicted is also effective for removing or reducing stenotic lesions in larger blood vessels (e.g., blood vessels in the leg above the ankle), thus providing users with the option to effectively treat various arterial sites during a single procedure using a single drive shaft 136.

[0102] Now for reference Figures 8-9 Additional embodiments of the distal portion of the drive shaft 136 include an alternative configuration of a grinding drill, which also provides relative orientation, relative spacing, and relative size of the torque transmission coils 137 along the drive shaft 136 to achieve an effective access path to such small arteries, including those with a vessel diameter typically 3 mm or less and whose access path follows a tortuous route. In the depicted embodiments, the components along the distal portion of the drive shaft 136 are similar to those of a combined... Figures 2-3 The described components, except that the distal and proximal grinding elements 140g have a cylindrical shape and are mounted axially aligned with the axis 135 of the torque transmission coil 137, include, for example, the torque transmission coil 137, the filament winding direction 138, the rotation direction 139, the intermediate grinding element 140b, the optional distal stabilizing element 142, and the optional distal end member 144, which are previously combined. Figures 8-9 and Figures 17-18 A similar configuration as described. Here, as... Figure 5As shown, the distal and proximal grinding drills 140g have a tubular shape similar to the distal stabilizing element 142 (for details of the tubular structure, see also [reference needed]). Figures 17-18 This arrangement ensures that when the distal and proximal grinding drills 140g are fixed to the outside of the torque transmission coil 137, the centroid and geometric center of each cylindrical element 140g are axially aligned with the central axis 135 of the torque transmission coil 137. Furthermore, the distal and proximal grinding drills 140g ( Figure 8 ) have the same diameter size (e.g., the one above) Figure 8 The diameter dimension G1 described in the text is smaller than that of the intermediate grinding drill 140b (e.g., the one above). Figures 17-18 The diameter dimension G2 described in [the text]. However, as [the text continues with details about diameter dimensions and diameter]. Figures 2-4 As shown, only one of the grinding drills (element 140b in this example) has a centroid offset from the central axis 135. Similar to the combination above... Figures 17-18 And the embodiments described in 8-15, Figures 17-18 The embodiments depicted are provided in the form of a "4-French-introducible" device as described above. Additionally, Figure 1 The abrasive drills 140g, 140b, and 140g shown, the optional distal stabilizing element 142, and the optional distal end member 144 can collectively provide relative orientation, relative spacing, and relative size along the torque transmission coil 137 to advantageously advance through relatively small percutaneous entry points, such as those in the patient's thigh with small inserter sheaths (e.g., refer to above). Figures 19-20 This is used to subsequently advance into the patient's foot or heart to remove (completely or partially) the narrowing material from the target artery.

[0103] Now for reference Figures 17-18 Additional embodiments of the distal portion of the drive shaft 136 include an alternative configuration of a grinding drill, which also provides a relative orientation, relative spacing, and relative size configuration of the torque transmission coils 137 along the drive shaft 136 to achieve an effective access path to such small arteries, including those where the vessel diameter is typically 3 mm or less and the access path follows a tortuous route. In the depicted embodiments, the components along the distal portion of the drive shaft 136 are similar to those of a combination... Figures 17-18 The described components, except for the distal and proximal grinding elements 140h which have a cylindrical shape and whose axial length is shorter than [missing information]. Figures 2-3 The cylindrical element 140g is depicted. For example, the torque transmission coil 137, the filament winding direction 138, the rotation direction 139, the intermediate grinding element 140b, the optional distal stabilizing element 142, and the optional distal end member 144 have features previously combined... Figures 8-9 and Figures 19-20 A similar configuration as described. Here, as... Figure 5As shown, the distal and proximal grinding drills 140h have a tubular shape, the diameter of which is similar to the diameter of the distal stabilizing element 142 (for details of the tubular structure, also refer to...). Figures 19-20 However, the axial length is shorter than the axial length of the distal stabilizing element 142 (e.g., in this embodiment, less than half the axial length of the distal stabilizing element 142). For example, the axial length of each of the distal and proximal grinding drills 140h is 0.6 mm to 0.8 mm, and in particular 0.76 mm in this embodiment (which is also smaller than the coil diameter in this embodiment). In this example, the axial length of the distal grinding element 142 is 1.75 mm to 2 mm, and in particular 1.9 mm in this embodiment (which is larger than the coil diameter in this embodiment). As previously described, the distal and proximal grinding drills 140h are fixed to the outside of the torque transmission coil 137 such that the centroid and geometric center of each cylindrical element 140h are axially aligned with the central axis 135 of the torque transmission coil 137. Moreover, the distal and proximal grinding drills 140h ( Figure 8 ) have the same diameter size (e.g., the one above) Figure 8 The diameter dimension G1 described in the text is smaller than that of the intermediate grinding drill 140b (e.g., the one above). Figures 19-20 The diameter dimension G2 described in the text. Figures 2-4 As shown, only one of the grinding drills (element 140b in this example) has a centroid offset from the central axis 135. Similar to the combination above... Figures 17-18 The embodiments described in 8-15 and 17-18, Figures 19-20 The embodiments depicted are provided in the form of a "4-French-introducible" device, as described above. Additionally, Figure 1 The abrasive drills 140g, 140b, and 140g shown, the optional distal stabilizing element 142, and the optional distal end member 144 can collectively provide relative orientation, relative spacing, and relative size along the torque transmission coil 137 to advantageously advance through relatively small percutaneous entry points, such as those in the patient's thigh with small inserter sheaths (e.g., refer to above). Figures 21-22 This is used to subsequently advance into the patient's foot or heart to remove (completely or partially) the narrowing material from the target artery.

[0104] Now for reference Figures 2-3 Additional embodiments of the distal portion of the drive shaft 136 include an alternative configuration of a grinding drill, which also provides a relative orientation, relative spacing, and relative sizing configuration of the torque transmission coils 137 along the drive shaft 136 to achieve an effective access path to such small arteries, including those where the vessel diameter is typically 3 mm or less and the access path follows a tortuous route. In the depicted embodiments, components along the distal portion of the drive shaft 136 are coupled with... Figure 2The components described are similar, except that: (i) those components are mounted within a more compact end length E' (compared to...). Figure 2 The end length E shown is short; (ii) the dimensions of the distal and proximal abrasive elements 140i are smaller than those of the intermediate abrasive element 140b; and (iii) the dimensions of the distal stabilizing element 142' are smaller (less than) Figures 2-3 The distal stabilizing element 142 shown. For example, the torque transmission coil 137, the filament winding direction 138, the rotation direction 139, the intermediate grinding element 140b, and the optional distal end member 144 have the same characteristics as previously combined. Figures 21-22 A similar configuration as described. Here, as... Figure 2 As shown, abrasive drills 140i, 140b, and 140i can be mounted on coil 137 to provide a more compact end length E' between the nearest abrasive element 140i and the most distal end of drive shaft 136. This can effectively treat stenotic lesions 107 in small arteries, such as stenosis in the foot below the ankle or stenosis in the coronary arteries. For example, the more compact end length E can be less than 1.8 cm from the most distal end of drive shaft 136, preferably 1.3 cm to 1.6 cm, and approximately 1.5 cm (0.60 inches) in the depicted embodiment. This end length E can be relatively compact compared to the total length of torque transmission coil 137 (e.g., see reference). Figures 21-22 The length B in the end length E' can be from 150 cm to 250 cm, and in this embodiment is about 197 cm (77.5 inches). Therefore, the end length E' can be less than 0.8% of the total length B. In some embodiments, the ratio of the total length B to the end length E is about 120:1 to 140:1, and in the depicted embodiment is about 129:1. Additionally, in the depicted embodiment, the grinding drills 140i, 140b, and 140i in the more compact end length E' comprise a total of three discrete elements spaced apart from each other. In other embodiments, the group of grinding elements within the more compact end length E' includes one, two, three, four, or five discrete grinding elements. Furthermore, within the more compact end length E' of the drive shaft 136, the farthest grinding drill 140i may be spaced by an extension length C' from the farthest end of the shaft, the intermediate grinding drill 140b may be spaced by a distance D' from its spacers, and the nearest grinding drill 140i may be spaced by the same distance D' from its spacers. In the depicted embodiment, the extension length C' is the same as the drill spacing distance D'. For example, the extension length C' can be 4 mm to 6 mm, and in the depicted embodiment it is about 5 mm (0.20 inches), while the drill spacing distance D' can also be 4 mm to 6 mm, and in the depicted embodiment it is about 5 mm (0.20 inches).

[0105] Still referencing Figure 21A set of grinding drills along the end length E' of the torque transmission coil 137 includes distal and proximal grinding drills 140i, which are smaller in size than the intermediate grinding drill 140b. For example... Figure 2 As shown, the distal and proximal grinding drills 140d have a diameter G3, and the intermediate grinding drill 140b has a larger diameter G2 (both G3 and G2 are larger than the combined diameter). Figure 22 The described coil diameter A). For example, the distal and proximal grinding drills 140i can have a diameter G3 of 0.9 mm to 1.1 mm, and particularly 1.0 mm in the embodiment depicted herein (e.g., a nominal diameter of 1.0 mm before applying the thin grinding coating), and the intermediate grinding drill 140b can have a diameter G2 of 1.2 mm to 1.33 mm, and particularly 1.25 mm in the embodiment depicted herein (e.g., a nominal diameter of 1.25 mm before applying the thin grinding coating). As previously mentioned, in such an example, the coil diameter A can be 0.7 mm to 0.9 mm, and preferably 0.8 mm in the depicted embodiment. Thus, in the depicted example, for each smaller grinding drill 140i mounted to the torque transmission coil 137, the drill-to-coil diameter ratio can be 1.2-1.3, and for the larger grinding drill 140b mounted to the torque transmission coil 137, the drill-to-coil diameter ratio can be 1.5-1.7. Similarly, as... Figures 2-3 As shown, the centroids of the distal grinding drill 140i, the intermediate grinding drill 140b, and the proximal grinding drill 140i are offset in different planes by a radial interval angle H. (As previously stated...) Figures 21-22 The radial spacing angle H is described as being from 5 degrees to 87.5 degrees, preferably from 20 degrees to 60 degrees, and in the embodiment depicted herein, it is 37.5 degrees. Therefore, the combined radial angle of all grinding drills 140i, 140b, and 140i along the end length E' of the drive shaft is less than 175 degrees (e.g., less than 120 degrees, and preferably less than 90 degrees in the illustrated embodiment).

[0106] Still referencing Figure 2 Some embodiments of the drive shaft 136 may include a distal stabilizing element 142' with a shorter axial length. For example, the axial length of the distal stabilizing element 142' may be less than the coil diameter of the torque transmission coil 137 (see reference). Figures 2-4 The described coil diameter is A). In this embodiment, the axial length of the distal stabilizing element 142' is 0.6 mm to 0.8 mm, and in this embodiment, it is specifically 0.76 mm. Here, the distal stabilizing element 142' has a cylindrical shape and may have an outer diameter larger than that of the distal and proximal grinding drills 140i (e.g., the aforementioned diameter G3), which is smaller than that of the intermediate grinding drill 140b (e.g., the aforementioned diameter G2). Similar to the above combination... Figures 21-22The embodiments described in 8-15 and 17-20, Figures 21-22 The embodiments depicted are provided in the form of a "4-French-introducible" device, as described above. Additionally, Figure 1 The grinding drills 140i, 140b, and 140i shown, the optional distal stabilizing element 142', and the optional distal end member 144 can collectively provide relative orientation, relative spacing, and relative dimensions along the torque transmission coil 137 to advantageously advance through relatively small percutaneous entry points, such as those in the patient's thigh with small inserter sheaths (e.g., refer to above). Figures 23-24 The device then moves to the patient's foot or heart to remove (completely or partially) the narrowing material from the target artery.

[0107] Now for reference Figures 21-22 Additional embodiments of the distal portion of the drive shaft 136 include an alternative configuration of a grinding drill, which also provides relative orientation, relative spacing, and relative size of the torque transmission coils 137 along the drive shaft 136 to achieve an effective access path to such small arteries, including those with a vessel diameter typically 3 mm or less and whose access path follows a tortuous route. In the depicted embodiments, the components along the distal portion of the drive shaft 136 are similar to those of a combined... Figure 2 The components described, except for the distal grinding element 140c, the intermediate grinding element 140b, and the proximal grinding element 140a, all have the same diameter (refer to the above combination). Figures 2-3 The diameter G described. For example, the torque transmission coil 137, the filament winding direction 138, the rotation direction 139, the intermediate grinding element 140b, the optional distal stabilizing element 142', and the optional distal end member 144 have the same characteristics as previously described. Figures 23-24 A similar configuration as described. And, similar to... Figures 23-24 In the embodiment shown, the distal grinding drill 140c and the proximal grinding drill 140a have the same diameter as the intermediate grinding drill 140b. However, as Figure 1 As shown, the grinding drill 140a-c is mounted in a more compact end length E' (as described above). Figures 25-26 (As described in the text). Similarly, as... Figures 19-20 As shown, the centroids of the distal grinding drill 140c, the intermediate grinding drill 140b, and the proximal grinding drill 140a are offset in different planes by a radial interval angle H. (As previously stated...) Figure 19 The radial spacing angle H is described as being from 5 degrees to 87.5 degrees, preferably from 20 degrees to 60 degrees, and in the embodiment depicted herein, it is 37.5 degrees. Therefore, the combined radial angle of all grinding drills 140a-c along the more compact end length E' of the drive shaft 136 is less than 175 degrees (e.g., less than 120 degrees, and preferably less than 90 degrees in the depicted embodiment).

[0108] Therefore, similar to the combination above Figure 19 The embodiments described in 8-15 and 17-22, Figures 2-3 The embodiments depicted are provided in the form of a "4-French-introducible" device, as described above. Additionally, Figures 8-9 The abrasive drills 140a-c, optional distal stabilizing element 142', and optional distal end member 144 shown may collectively provide relative orientation, relative spacing, and relative dimensions along the torque transmission coil 137 to advantageously advance through relatively small percutaneous entry points, such as those in the patient's thigh with small inserter sheaths (e.g., refer to above). Figures 25-26 ( ), so that it can then proceed to the patient's foot or heart to remove the narrowing material (completely or partially) from the target artery.

[0109] Now for reference Figure 19 Additional embodiments of the distal portion of the drive shaft 136 include an alternative configuration of a grinding drill, which also provides a relative orientation, relative spacing, and relative sizing configuration of the torque transmission coils 137 along the drive shaft 136 to achieve an effective access path to such small arteries, including those where the vessel diameter is typically 3 mm or less and the access path follows a tortuous route. In the depicted embodiments, the components along the distal portion of the drive shaft 136 are similar to those of a combined... Figures 25-26 The described components, except for the distal and proximal grinding elements 140j coaxially mounted to the torque transmission coil 137, have a spherical shape (instead of) Figure 8 The cylindrical shape of element 140h in the middle) and the optional distal stabilizing element 142 are removed (so that with Figure 8 In comparison, grinding elements 140j and 140b are positioned closer to the farthest end. For example, the torque transmission coil 137, the filament winding direction 138, the rotation direction 139, the intermediate grinding element 140b, and the optional distal end member 144 have the same characteristics as previously combined. Figures 25-26 and Figures 2-4 A similar configuration as described. Here, as... Figures 25-26 As shown, the distal and proximal grinding drills 140j have a spherical shape coaxially mounted with the torque transmission coil 137, and the intermediate grinding drill 140b has a center of mass offset from the central axis 135. Figures 25-26 The concentric grinding drill 140h described in the previous embodiment is very similar. In this embodiment, the distal and proximal grinding drills 140j are fixed to the outside of the torque transmission coil 137, such that the centroid and geometric center of each spherical element 140j are axially aligned with the central axis 135 of the torque transmission coil 137. Moreover, the distal and proximal grinding drills 140j ( Figure 1 ) have the same diameter size (e.g., the one above) Figure 27 The diameter dimension G1 described in the text is smaller than that of the intermediate grinding drill 140b (e.g., the one above).Figures 2-3 (as described in the diameter dimension G2). In some embodiments, the distal and proximal grinding drills 140j have the same diameter dimension of 1.0 mm to 1.15 mm, and particularly 1.1 mm in the embodiment depicted herein (e.g., a nominal diameter of 1.1 mm before the application of the thin grinding coating), and the intermediate grinding drill 140b may have a diameter of 1.2 mm to 1.33 mm, and particularly 1.25 mm in the embodiment depicted herein (e.g., a nominal diameter of 1.25 mm before the application of the thin grinding coating). Figure 27 As shown in the example, only one of the grinding drills 140j, 140b, and 140j mounted to shaft 137 (element 140b in this example) has a centroid offset from the central axis 135. Additionally, the furthest grinding drill 140j may be spaced from the furthest face of shaft 136 by an end length C'', the intermediate grinding drill 140b by a distance D'' from its spacer drills, and the nearest grinding drill 140j by the same distance D'' from its spacer drills. In the depicted embodiment, the end length C'' and the drill distance D'' are different. For example, the end length C'' may be 0.6 mm to 1.1 mm, approximately 1 mm (preferably approximately 0.04 inches) in the depicted embodiment, while the drill distance D'' may be 4 mm to 6 mm, approximately 5 mm (preferably approximately 0.20 inches) in the illustrated embodiment. Therefore, in this embodiment, all grinding drills 140j, 140b, and 140j in the series are positioned significantly close to the furthest end of drive shaft 136. For example, in this embodiment, the nearest grinding drill 140j can be coaxially mounted to the torque transmission coil at a position less than one inch from the farthest end of the drive shaft 136 and preferably no more than 0.5 inches from the farthest end of the torque transmission coil.

[0110] Similar to the combination above Figures 26-25 The embodiments described in 8-15 and 17-18, Figures 2-3 The embodiments depicted are provided in the form of a "4-French-introducible" device, as described above. Additionally, Figure 27 The grinding drills 140j, 140b, and 140j shown, along with the optional distal end member 144, can collectively provide relative orientation, relative spacing, and relative size along the torque transmission coil 137 to advantageously advance through relatively small percutaneous entry points, such as those in the patient's thigh with small inserter sheaths (e.g., refer to above). Figure 27 This is used to subsequently advance into the patient's foot or heart to remove (completely or partially) the narrowing material from the target artery.

[0111] refer to Figure 28In some embodiments, the rotary cutting system 200 for removing (partially or completely) a stenotic lesion 207 from a target vessel 205 may include an actuator handle assembly 210 for controlling movement of an elongated flexible drive shaft assembly 230. The drive shaft assembly 230 includes a flexible drive shaft 236, and the distal portion of the drive shaft 236 includes one or more abrasive elements 240a-c configured to abrade the stenotic lesion 207 in the target vessel 205. In some embodiments, the rotary cutting system 200 shares features with the rotary cutting system 100 (e.g., including a power supply 128, a power adapter 120, and a fluid source 125).

[0112] The abrasive elements 240a-c may have a selected configuration and relative dimensions along the distal portion of the drive shaft 236 to improve navigation into smaller vessels below the ankle or in the heart, while also achieving an efficient trajectory path for abrading stenotic material 207 in these vessels. (In the depicted example, the target vessel 205 has a vessel diameter VD of 3 mm or less, approximately 2.5 mm as shown, while the initial path through the stenotic lesion is significantly smaller than this diameter.) Optionally, the abrasive element 240 and the drive shaft 236 may have a selected configuration and relative dimensions (e.g., Figure 29 (8-15, 17-26), which advantageously provides advance of a small percutaneous introducer 208 (e.g., sized to slidably receive an instrument with a diameter of 4 Frenchies or smaller) through a percutaneous opening 209 in the patient's leg, and can further navigate through the stenotic lesion 207 in the small artery 205, such as an artery below the ankle (e.g., in the foot) or a coronary artery (e.g., in the left anterior descending coronary artery or the left circumflex coronary artery), before sweeping across a larger orbital path (during rotation of the drive shaft 236) to grind the stenotic material 207. For example, in Figures 30-31 In the illustrated embodiment, the drive shaft 236 and the grinding elements 240a-c have the above-described combination. Figures 32-33 The described configuration (e.g., drive shaft 136 and grinding elements 140j, 140b, and 140j). From this description, it should be understood that other configurations of the grinding elements and features along the distal end of the drive shaft (e.g.) Figure 31 The options described in 8-15 and 17-24 can be found in Figure 33 Implemented in System 200.

[0113] System 200 may also include a power adapter 120 and a fluid source 125 (e.g., a saline bag) connectable to brake handle assembly 210, and brake handle assembly 210 may house an electric motor 212 (configured to drive rotation of drive shaft 236) and a fluid pump 214 (configured to agitate fluid so that saline solution is directed toward the distal portion of drive shaft 236). As described in more detail below, a controller 150 for starting the electric motor 212 and pump 214 (responding not only to the position of user interface button 216 along actuator slot 213, but also to input at user interface buttons 216 and 217a-c on handle assembly 210) may be contained within housing 122 of power adapter 120 such that after the first handle assembly 210 is discarded, it can be reused with subsequent handle assemblies (disposable handle assembly). Alternatively, the controller 250A for operating the electric motor 212 and pump 214 can be housed within a housing in the handle assembly 210 (close to the electric motor 212 and pump 214), and the entire handle assembly 210 can be discarded after a single patient use. In either option, the handle assembly 210 can be operated by a clinician using a simplified screenless interface for controlled excision procedures (e.g., without a graphic display along the handle assembly or on a separate unit attached to the handle assembly).

[0114] Still referencing Figure 28 The elongated flexible drive shaft assembly 230 includes a sheath 232 that extends over the flexible drive shaft 236, such that the grinding elements 240a-c on the distal portion of the drive shaft 236 are positioned proximally (e.g., Figures 28-29 and Figures 25-26 The retracted position shown is accommodated within the distal end of the sheath 232. In this position, the actuator 216 is positioned at the proximal end of the rearmost part of the slot 213. In response to a clinician moving (translating) the actuator 216 distally along the slot 213 by a first translational distance 203 (from the distal end of the slot 213), the abrasive elements 240a-c extend distally from the distal end of the sheath 232 (e.g., Figures 25-26 From there, the clinician can translate the actuator 216 distally along the slot 213 by a second translation distance 204 (e.g., Figure 6 Optionally, the actuator 216 can be engaged during the rotation of the drive shaft 236. Figure 27 and Figure 5 The actuator 216 reciprocates between its extended positions within the slot. Additionally, in response to a clinician moving (translating) the actuator 216 proximally along the slot 213 at its final proximal end, the actuator 216... Figure 27 The grinding elements 240a-c retract and are housed within the furthest end of the sheath 232 (e.g., Figure 27The proximal end of the sheath 232 is secured to the distal end of the handle assembly 210. A flexible drive shaft 236 is slidably and rotatably disposed within a cavity of the sheath 232. The flexible drive shaft 236 defines a longitudinal cavity in which a guidewire 234 is slidably disposed. The guidewire 234 can extend through the handle assembly 210, the sheath 232, and the drive shaft 236 such that the proximal end of the guidewire 234 protrudes proximally from the rear port of the guidewire brake 218 at the proximal end of the handle assembly 210, while the distal end of the guidewire 234 extends distally to the furthest end of the drive shaft 236. In this embodiment, the flexible drive shaft 236 includes one or more helically wound filaments of torque transmission coils that define a longitudinal cavity along a central longitudinal axis. The drive shaft 236 is configured to rotate about the longitudinal axis while the sheath 232 remains substantially stationary. Therefore, during the excision procedure, the sheath 232 and guidewire 234 are substantially stationary, while the flexible drive shaft 236 can be moved in a controlled manner (e.g., rotated about a longitudinal axis and periodically translated longitudinally proximally and / or distally). The distal end of the sheath 232 includes a marker 233, such as a radiopaque marker, which can be used during the excision procedure to image the position of the distal end of the sheath 232.

[0115] In the depicted embodiment, the distal portion of the drive shaft 236 (which may optionally retract into and extend from the sheath 232) includes one or more abrasive elements 240a-c and (optionally) a concentric end member 244 (see reference). Figures 26-25 (concentric end member 144 in the middle). In the depicted embodiment, one or more grinding elements include a set of three eccentric grinding elements 240a-c, which are fixedly mounted to the outside of the torque transmission coil of the drive shaft 236, such that the distal and proximal grinding drills 240h have a spherical shape coaxially mounted to the torque transmission coil 237, and the intermediate grinding drill 240b has a centroid offset from the central axis 235 (e.g., as shown in the figure). Figures 25-26 (As shown). Therefore, the centroid of each of the distal and proximal grinding drills 240h is aligned with the central axis of the drive shaft 236, while the centroid of the intermediate grinding drill 240b is offset from the central axis of the drive shaft 236. Concentric end member 244 (reference) Figure 8 The concentric distal member 244 is fixed to the distal end of the torque transmission coil and extends distally therefrom. As described in more detail above, the concentric distal member 244 has a smoother surface than the abrasive surfaces of the abrasive elements 240a-c, and the concentric distal member 244 can be configured to provide initial penetration (and optionally, dilation) through the stenotic lesion 207 in the target vessel 205.

[0116] Still referencing Figure 8When the drive shaft 236 rotates about its longitudinal axis, the eccentric grinding elements 240a-c (and the portion of the drive shaft 236 to which one or more grinding elements 240a-c are fixed) will be pushed in the track path relative to the central axis of the drive shaft 236 (also as described above with respect to the drive shaft 136, for example, in conjunction with Figure 27 Typically, a faster rotational speed (rpm) of the drive shaft 236 will result in a larger diameter track (within the limitations of the vessel diameter). One or more abrasive elements 240a-c moving along the track will contact the stenotic lesion 207 to grind the lesion to a reduced size using each transverse path through the lesion 207 (i.e., small particles of the lesion will be ground away from the lesion). As further described below, simultaneously with the rotation of the drive shaft 236, the drive shaft 236 can be translated back and forth (distal and proximal) along its longitudinal axis. Thus, by means of the simultaneous translation of the abrasive elements 240a-c and the rotation of the track, the stenotic lesion 207 can be ground radially and longitudinally.

[0117] Additionally, the torque transmission coil of the flexible drive shaft 236 is laterally flexible (similar to the flexible drive shaft 136), allowing the drive shaft 236 to easily advance through tortuous arterial paths (e.g., in the foot arterial ring or in coronary branch arteries), and enabling a portion of the drive shaft 236 at and near one or more grinding elements 240 to be laterally deflected when subjected to centrifugal forces generated by the rotation of one or more eccentric grinding elements 240. In the illustrated embodiment, the drive shaft 236 comprises one or more helically wound wires (or filaments) providing a uniform coil diameter smaller than the diameter of all grinding elements 240a-c. As described in more detail above, this relative dimension is referred to as the drill-to-coil diameter ratio, and for all grinding drills (elements 240a-c) along the torque transmission coil of the drive shaft, the drill-to-coil diameter ratio may be approximately 1.3-1.7. In this way, the torque transmission coil of the flexible drive shaft 236 can achieve sufficient lateral flexibility during navigation through tortuous paths (e.g., in a patient's foot or heart) and sufficient longitudinal rigidity to be propelled through stenotic lesions in small arteries (while transmitting torque to rotate grinding elements 240a-c). In some embodiments, the flexible drive shaft 236 shares features with the flexible drive shaft 136.

[0118] Still referencing Figures 34-35One or more abrasive elements 240a-c (each of which may also be referred to as an abrasive drill) may comprise a biocompatible material coated with an abrasive medium such as diamond grit, diamond particles, silicon carbide, etc. In the depicted embodiments, the abrasive elements 240a-c comprise a total of three discrete abrasive balls / cylinders spaced apart from each other to facilitate navigation to and orbital abrasion within the target arteriole, including those with a vessel diameter typically 3 mm or less and whose entry path follows a tortuous route. As previously described, in Figures 27-35 In the illustrated embodiment, the drive shaft 236 and the grinding elements 240a-c have the above-described combination. Figures 28-29 The described configuration (e.g., drive shaft 136 and grinding elements 140j, 140b, and 140j). Thus, the distal and proximal grinding drills 240h (as in...) Figures 30-31 In 140j) they have the same diameter size (e.g., the one above). Figures 32-33 The diameter dimension G1 described in the text is smaller than that of the intermediate grinding drill 240b (e.g., the one above). ​ The diameter dimension G2 described herein. In some embodiments, the distal and proximal grinding drills 240h have the same diameter dimension of 1.0 mm to 1.15 mm, and particularly 1.1 mm in the embodiment depicted herein (e.g., nominal diameter of 1.1 mm before the application of a thin grinding coating), and the intermediate grinding drill 240b may have a diameter of 1.2 mm to 1.33 mm, and particularly 1.25 mm in the embodiment depicted herein (e.g., nominal diameter of 1.25 mm before the application of a thin grinding coating). The grinding drills 240a-c can be mounted to the exterior of the torque transmission coil of the drive shaft 236 using biocompatible adhesives, high-temperature solders, welding, press fitting, etc. Alternatively, one or more grinding elements 240a-c may be integrally formed with the filament of the drive shaft 236 as a single structure (e.g., using filaments wound in different patterns to create an axial offset structure, etc.).

[0119] Still referencing ​ The rotary cutting system 200 also includes an actuator handle assembly 210. The actuator handle assembly 200 may share features with the actuator handle assembly 110. For example, the actuator handle assembly 210 includes a housing 211 and an internal bracket assembly 245 that translates along the actuator slot 213. ​In some embodiments, a user can grip actuator 216 to actuate movement along actuator slot 213, which causes internal bracket assembly 245 to slidably translate along the longitudinal axis of handle assembly 210, as indicated by arrow 215. In some embodiments, the bracket assembly can translate, but is not limited to, about 8 cm to about 12 cm, or about 6 cm to about 10 cm, or about 4 cm to about 8 cm, or about 6 cm to about 14 cm. As the bracket assembly translates relative to housing 211, drive shaft 236 translates correspondingly relative to sheath 232. As previously described, actuator 216 of handle assembly 210 includes a rotary power button that can actuate electric motor 212 (carried by internal bracket assembly) to drive rotation of drive shaft 236. Therefore, by reciprocating the actuator 216 and engaging the power button, the user can reciprocate the distal portion of the drive shaft 236 relative to the stenotic lesion 207 in both distal and proximal directions, while the abrasive elements 240a-c rotate along the track and are positioned distal to the farthest end of the sheath 232. Additionally, the user can retract and extend the distal portion of the drive shaft 236 (including the abrasive elements 240a-c) relative to the distal end of the sheath 232 to retract the abrasive elements 240a-c into the sheath 232 and extend the abrasive elements 240a-c from the distal end of the sheath 232 to expose the abrasive elements 240a-c.

[0120] Handle assembly 210 has a cable connection 121 to a power adapter 120 (configured to receive power from a power source 128 such as a wall plug) and a fluid line connection 126 to a brine source 125. Cable 121 can transmit both power and data (e.g., when controller 150 is housed within power adapter housing 122), or alternatively, can transmit power (e.g., when this version is implemented using controller 250A housed within handle housing 211). Cable 121 includes a removable connection socket, allowing handle assembly 210 to be easily discarded after a single use, and power adapter 120 to be reused with subsequent handle assemblies. Fluid line connection 126 may include a Luer connector and a flow switch valve, allowing the user to removably connect the handle assembly to a rod-mounted brine bag or other fluid source 125 without requiring an external pump mechanism positioned outside handle housing 211.

[0121] refer to ​In operation of system 200, a user can translate the actuator 216 of handle assembly 210 within actuator slot 213 to retract and extend abrasive elements 240a-c from the distal end of sheath 232. For example, retraction of abrasive elements 240a-c within sheath 232 can advantageously cover the abrasive surface during navigation of abrasive elements 240a-c to the target area, thereby reducing the likelihood of scraping or engaging unintended areas of blood vessels along the navigation path. Then, after navigation to the target site (e.g., for rotary cutting treatment), the user can selectively adjust abrasive elements 240a-c distally from the sheath 232 cavity. Also, as described in more detail below, system 200 can be configured to automatically prevent rotation of drive shaft 236 when abrasive elements 240a-c are retracted within the sheath cavity. ​ ), and provides selective actuation of the drive shaft rotation when the grinding element is in the extended position (e.g., ​ and ​ Therefore, system 200 can provide additional safety controls that facilitate improved and intuitive operation for the user during navigation and during rotary cutting treatment.

[0122] In some embodiments, a user can grasp actuator 216 to actuate movement along actuator slot 213, which allows internal bracket assembly 245 to be slidably translated along the longitudinal axis of handle assembly 210, as indicated by arrow 215, to various positions within actuator slot 213. As bracket assembly 245 translates relative to housing 211, drive shaft 236 translates correspondingly relative to sheath 232. Thus, a user can retract and extend the distal portion of drive shaft 236 (including grinding elements 240a-c) relative to the distal end of sheath 232. For example, a user can translate actuator 216 proximally to... Figure 28 , 29 The position of 35 is used to retract the grinding elements 240a-c back into the sheath 232.

[0123] exist Figure 28 , 29 In the proximal position shown in Figure 35, the abrasive elements 240a-c are retracted and housed within the distal end of the sheath 232. The sheath 232 covering the abrasive elements 240a-c facilitates navigation to and from target arterioles, including those with a vessel diameter typically 3 mm or less and whose access path follows a tortuous route. For example, the sheath 232 may include a smooth outer surface that facilitates navigation and protects the tortuous route from areas that are not the target region (e.g., preventing the abrasive elements 240a-c from engaging with areas outside the target region).

[0124] In response to the actuator 216 translating to Figure 28 , Figure 29 and Figure 35In the depicted proximal position, no power is supplied to the electric motor 212 regardless of whether the rotary power button of actuator 216 is actuated. For example, handle assembly 210 may include a switch 241 controlling the power delivery to electric motor 212. Figure 35 In some embodiments, switch 241 is at least one of a mechanical switch, an optical switch, a magnetic switch, a rotary switch, a button, or a combination thereof. In the proximal position, the bracket assembly 245 connected to actuator 216 slides proximally and contacts switch arm 243 to press switch 241. When switch 241 is pressed, power is not delivered to electric motor 212, and rotation of drive shaft 236 is prevented. Thus, when abrasive elements 240a-c retract into sheath 232, rotation of drive shaft 236 and abrasive elements 240a-c is prevented. Preventing rotation of drive shaft 236 and abrasive elements 240a-c (which can be performed by the controller described above) advantageously reduces the possibility that one or more abrasive elements 240a-c abrade the interior of sheath 232. Therefore, in the proximal position, if the user presses the power button, power will not be supplied to electric motor 212, and drive shaft 236 will not rotate.

[0125] exist Figure 30 , 31 At the threshold position depicted in 34, the abrasive elements 240a-c extend from the distal end of the sheath 232 to a minimum distance from the distal end of the sheath 232, wherein the abrasive elements 240a-c are allowed to rotate and revolve in the track path to contact and remove portions of the target lesion 207 (even portions of the lesion that are farther from the axis of the drive shaft 236 than the maximum radius of the abrasive elements 240a-c).

[0126] Still referencing Figures 27-35 In response to the actuator 216 translating to Figure 30 , 30 At the threshold position depicted in section 34, power is supplied to the electric motor 212. For example, in the threshold position, the bracket assembly 245 connected to the actuator 216 slides distally and releases contact with the switch arm 243, disengaging the switch 241. With the switch 241 disengaged, power is delivered to the electric motor 212, and when the user presses the power button, the drive shaft 236 is allowed to rotate. Therefore, in the threshold position, in response to the user pressing the power button, power is supplied to the electric motor 212, and the drive shaft 236 rotates.

[0127] exist Figure 32 and 33In the depicted distal position, the abrasive elements 240a-c extend further from the distal end of the sheath 232 to a maximum distance from the distal end of the sheath 232, wherein the abrasive elements 240a-c are allowed to rotate and revolve in the track path, thereby contacting and removing portions of the target lesion 207 (even portions of the lesion that are farther from the axis of the drive shaft 236 than the maximum radius of the abrasive elements 240a-c).

[0128] In response to the actuator 216 translating to Figure 30 , 30 In the distal position depicted in Figure 34, the electric motor 212 remains connected to the power source. For example, in the distal position, the bracket assembly 245 connected to the actuator 216 slides further distally, and the switch arm 243 remains disengaged from the switch 241. With the switch 241 disengaged, power is delivered to the electric motor 212, and the drive shaft 236 is allowed to rotate when the user presses the power button. Thus, in the distal position, in response to the user pressing the power button, power is supplied to the electric motor 212, and the drive shaft 236 rotates. In some embodiments, simultaneously with the rotation of the drive shaft 236, the drive shaft 236 can translate back and forth (distal and proximal) along the longitudinal axis of the drive shaft 236 between the threshold position and the distal position. Thus, by means of the simultaneous translation and orbital rotation of the abrasive elements 240a-c, the stenotic lesion 207 can be abraded radially and longitudinally. If the user moves the actuator 216 more than the threshold position, power supply to the electric motor 212 is stopped, and the rotation of the grinding elements 240a-c also stops.

[0129] In order to operate the handle assembly 210 during the rotary cutting procedure, the clinician can grasp the actuator 216 and actuate (translate) the actuator 216 to... Figure 30 , Figure 31 and Figure 34 At the threshold position shown or at a position distal to it, and by pressing the rotary power button (on actuator 216) with the same hand. At the distal end of actuator 216 (e.g., from... Figure 28 , 29During actuation or translation (as shown in the proximal position in 35), the abrasive elements 240a-c advance distally beyond the distal end of the sheath 232 and expose the target area. Additionally, switch 241 is disengaged and power is supplied to the electric motor 217. The clinician can move (translate) the actuator 116 distally and proximally (e.g., back and forth relative to the housing 211) along the slot 213 while holding the rotary power button of the actuator 216 in the pressed position and simultaneously holding the abrasive elements 240a-c beyond the distal end of the sheath 232. In this way, the target lesion 207 can be abraded radially and longitudinally by means of the orbital rotation and translation generated by the abrasive elements 240a-c.

[0130] To further manipulate the handle assembly 210 during the excision procedure, the clinician can select the rotation speed using electrical switches 217a and 217b. In some cases, the rotation speed can be selected via a set of predefined speeds (e.g., at least two predefined speed settings, such as "low" and "high"), where electrical switch 217a causes an increase in the speed setting and electrical switch 217b causes a decrease in the speed setting. Optionally, each of the electrical switches 217a-b may also include a light indicator. For example, when electrical switches 217a-b allow selection of "high" and "low" speeds respectively, each electrical switch 217a-b may have a single lamp such that when a speed is selected, the lamp corresponding to the selected electrical switch 217a or 217b is illuminated to notify the clinician of the selected speed. In some embodiments, light can be emitted through electrical switches 217a and 217b. Alternatively, the lamp may be positioned proximal to the electrical switches 217a-b. As another example, when electrical switches 217a-b allow speed to be modified within a speed range, the light indicator can be a light bar such that the number of lights illuminated on the light bar corresponds to the selected speed.

[0131] Still referencing Figures 27-35 To further operate the handle assembly 210, the handle assembly 210 may include a fluid pump switch 217c. The fluid pump switch 217c may share features with the fluid pump switch 117c, such as activating the internal fluid pump 214 to draw fluid (e.g., saline in this embodiment) from the fluid line 126 and propel the fluid through the sheath 232 toward the distal portion of the drive shaft 236. Thus, the fluid pump switch 217c can be used to initially perfuse the sheath 232 (and remove air before insertion into the patient) and then selectively initiate additional flushing fluid through the sheath 232 and into the blood vessel 205. In some cases, a first press of the fluid pump switch 217c will turn on the internal pump 214, while a second press will turn off the pump 214. In some embodiments, the fluid pump switch 217c includes a light indicator such that a light is illuminated when the pump is turned on to notify the clinician that the pump is on.

[0132] In the depicted embodiment, the handle assembly 210 also includes a guidewire brake 218, which may share features with the guidewire brake 118. For example, the guidewire brake 218 may be selectively actuated (e.g., pivoted relative to the handle housing 211 in this embodiment) to releasably clamp the guidewire 234 in a rest position relative to the handle assembly 210 (and consequently, remain stationary relative to rotational movement of the drive shaft 236 during resection treatment). When the drive shaft 236 and the handle assembly 210 advance over the guidewire 234 to place one or more abrasive elements 238 at a target location within the patient's blood vessel, the guidewire brake 218 is in a non-activated state (e.g., rotated counterclockwise about the central guidewire axis from a rear view), allowing the handle assembly 210 to slide freely relative to the guidewire 234. Then, when the clinician is ready to begin the resection treatment, the guidewire brake 218 can be activated (e.g., pivoted clockwise about the central guidewire axis) to mechanically engage the exterior of the guidewire 234 and thereby releasably retain / lock the guidewire 234 relative to the handle assembly 210. Thus, when the drive shaft 236 rotates, the guidewire 234 will not rotate, and when the actuator 216 is manually translated in direction 215, the guidewire 234 will not translate.

[0133] In some embodiments, the handle assembly 110 may include a wire brake light 219 positioned along the upper surface of the handle housing 211 near other user interface buttons 217a-c and adjacent to the wire brake 218. This allows the user to easily observe the wire brake light 219 (e.g., similar to wire brake light 119) and receive confirmation that the wire brake 218 is fully engaged (to clamp the wire 234) before selecting the rotation speed (e.g., buttons 217a-b) and initiating rotation (e.g., a button on actuator 216). Therefore, the screenless user interface of the handle assembly 210 provides the user with simplified and smooth hand movements while also conveying useful information.

[0134] Optionally, controller 250 (or 250A in other embodiments) may be configured to prevent electric motor 212 from driving rotation of drive shaft 236 until: (1) guidewire brake 218 is activated (e.g., guidewire brake light 119 is illuminated), (2) pump 214 is activated to drive flushing fluid (e.g., via actuating fluid pump switch 117c, then illuminating button 117c), (3) rotational speed has been selected via speed selection switches 217a and 217b (e.g., speed indicator lights thereon are activated), (4) switch 241 is disengaged in response to the position of actuator 216, or a combination of all these conditions. As another example, indicator lights associated with selection switches 217a and 217b, fluid pump switch 217c, and guidewire brake light 219 will warn clinicians not to operate rotary cutting system 200 until all four systems (actuator, motor, pump, and guidewire brake positions) are activated and in the working position. For example, each system can have a green light, so that three green lights indicate to the clinician that the resection can proceed. Optionally, only (1) switch 241 is disengaged and (2) guidewire 118 is actuated to allow rotation of the rotary cutting system 200. Optionally, only switch 241 is disengaged to allow rotation of the rotary cutting system 200.

[0135] Still referencing Figures 27-35The rotary cutting system 200 also includes a controller 150, which in this embodiment includes a processor and a computer-readable storage device thereon storing control instructions. The controller 150 is configured to receive input from sensors housed within the handle assembly, input from a user interface (e.g., switches / actuators 216, 217a-c, 218, and 241) on the handle assembly 210, and control the activation of the electric motor 212 and the pump 214 (in response to input at the user interface switches / actuators). In this embodiment, the controller 150 is contained within the housing 122 of the power adapter 120, such that the controller 150 can be reused with subsequent handle assemblies after the first handle assembly 210 is discarded (e.g., after use on the first patient). As previously described, the cable 121 provides data communication between the controller 150 and components of the user interface (e.g., switches / actuators 216, 217a-c, 218, and 241), the electric motor 212, the pump 214, and the feedback sensors housed within the handle assembly 210. In an alternative embodiment, the controller (including a processor and a computer-readable storage device for storing control instructions) may be provided in the form of controller 250A, which is configured to be housed within the housing 211 of the handle assembly 210 (close to the electric motor 212 and pump 214). In both options, the handle assembly 210 can be operated by a clinician using the simplified screenless interface described above for controlled percutaneous surgery (e.g., without a user interface display along the handle assembly or on the unit attached to the handle assembly). Preferably, controller 150 (or controller 250A) is housed in a sealed manner to prevent contact with fluids (e.g., saline, blood, etc.) encountered by the handle assembly.

[0136] Several embodiments of the invention have been described. However, it should be understood that various modifications can be made without departing from the spirit and scope of the invention. For example, design features of the embodiments described herein can be combined with other design features of other embodiments described herein. Therefore, other embodiments are within the scope of the appended claims.

Claims

1. A rotary cutting system for removing stenotic lesion material from a patient's foot artery or coronary artery, comprising:

4. French can introduce rotary cutting devices, including: A torque transmission coil consisting of one or more filaments, the filaments being helically wound from distal to proximal end along the filament winding direction to define the coil diameter and the drive shaft axis; and A series of grinding drills, fixedly mounted to the distal portion of the torque transmission coil, having a maximum drill diameter not exceeding 1.25 mm, comprising: a distal concentric grinding drill, coaxially mounted to the distal end of the torque transmission coil; a proximal concentric grinding drill, the same size as the distal concentric grinding drill, coaxially mounted to the torque transmission coil at a distance not exceeding 0.5 inches from the distal end of the torque transmission coil; and a central eccentric grinding drill, larger than both the distal and proximal concentric grinding drills, mounted to the torque transmission coil with its center of mass offset from the drive shaft axis; and... A rotary cutting handle assembly, which is coupled to the proximal end of the torque transmission coil and houses an electric motor configured to drive the series of grinding drills to rotate about the drive shaft axis in a rotational direction in response to user input at the actuator of the rotary cutting handle assembly.

2. The rotary cutting system of claim 1, further comprising a sheath extending from the rotary cutting handle assembly and on the torque transmission coil, wherein, The actuator of the rotary cutting handle assembly is configured to adjust the torque transmission coil longitudinally relative to the sheath, such that in the proximal position, the series of grinding drills are accommodated within the farthest end of the sheath.

3. The rotary cutting system according to claim 2, wherein, In response to the distal longitudinal movement of the actuator of the rotary cutting handle, the series of grinding drills are adjusted to a distal position so as to extend distally from the distal end of the sheath.

4. The rotary cutting system according to claim 3, wherein, When the series of grinding drills are in the proximal position and housed within the farthest end of the sheath, the electric motor housed within the rotary cutting handle is prevented from rotating the torque transmission coil.

5. The rotary cutting system according to claim 4, wherein, When the series of grinding drills is adjusted to the distal position to extend distally from the distal end of the sheath, a switch housed within the rotary cutting handle is triggered, and the electric motor is selectively activated to drive the rotation of the series of grinding drills.

6. The rotary cutting system according to claim 5, wherein, When the actuator of the rotary cutting handle assembly is adjusted along the upper surface of the rotary cutting handle assembly to a position proximal to the threshold position, the series of grinding drills are in the proximal position and housed within the farthest end of the sheath.

7. The rotary cutting system according to claim 6, wherein, When the actuator of the rotary cutting handle assembly is adjusted along the upper surface of the rotary cutting handle assembly to a position distal to the threshold position, the series of grinding drills are in the distal position and extend distally from the distal end of the sheath.

8. The rotary cutting system according to claim 1, wherein, The torque transmission coil has an outer diameter, and each of the series of grinding drills has a corresponding drill diameter, wherein the drill-to-coil diameter ratio, defined by each corresponding drill diameter and the outer diameter of the coil, is approximately 1.3-1.

7.

9. The rotary cutting system according to claim 1, wherein, The diameter of the proximal concentric grinding drill is equal to the diameter of the distal concentric grinding drill, and the diameters of the proximal concentric grinding drill and the distal concentric grinding drill are smaller than the diameter of the intermediate eccentric grinding drill.

10. The rotary cutting system according to claim 9, wherein, The diameter of the central eccentric grinding drill is 1.25 mm, and the diameter of each of the proximal concentric grinding drill and the distal concentric grinding drill is 1.1 mm.

11. The rotary cutting system according to claim 10, wherein, Each of the series of grinding drills is a spherical metal drill coated with diamond abrasive.

12. The rotary cutting system according to claim 1, wherein, The electric motor housed within the rotary cutting handle is configured to rotate the torque transmission coil, causing the series of abrasive drills to run in the rotational direction opposite to the filament winding direction.

13. A method for rotary cutting in the foot artery below the ankle, comprising: The torque transmission coil of the rotary cutting device is advanced on the guide wire and into the foot artery below the ankle, such that at least one abrasive drill installed at the distal portion of the torque transmission coil approaches the stenotic lesion within the foot artery. as well as The torque transmission coil of the rotary cutting device is rotated, causing the at least one grinding drill mounted on the torque transmission coil to grind the stenotic lesion within the foot artery.

14. The method according to claim 13, wherein, The rotation of the torque transmission coil includes manually actuating the actuator of the rotary cutting handle assembly to activate an electric motor housed within the rotary cutting handle assembly, such that the electric motor drives the at least one grinding drill to rotate in the rotational direction.

15. The method of claim 14, further comprising retracting a sheath positioned on the at least one abrasive drill until the at least one abrasive drill is exposed within the foot artery.

16. The method according to claim 15, wherein, The sheath extends from the rotary cutting handle assembly and over the torque transmission coil, and the method further includes sliding the actuator of the rotary cutting handle assembly along the upper surface of the rotary cutting handle assembly to adjust the torque transmission coil longitudinally relative to the sheath.

17. The method of claim 16, wherein the actuator of the rotary cutting handle is slidably movable to adjust the at least one abrasive drill from a proximal position to a distal position, wherein in the proximal position the at least one abrasive drill is received within the distal end of the sheath, and in the distal position the at least one abrasive drill extends distally from the distal end of the sheath.

18. The method according to claim 17, wherein, When the at least one grinding drill is in the proximal position and housed within the farthest end of the sheath, the electric motor housed within the rotary cutting handle is prevented from rotating the torque transmission coil.

19. The method according to claim 13, wherein, The rotary cutting device is a 4-French rotary cutting device.

20. The method according to claim 19, wherein, The at least one grinding drill includes a set of three spherical grinding drills, the set of three spherical grinding drills including a furthest concentric grinding drill, a middle eccentric grinding drill, and a closest concentric grinding drill, wherein the furthest concentric grinding drill is directly mounted to the furthest end of the torque transmission coil, and the closest concentric grinding drill is mounted to the torque transmission coil at a position no greater than 0.5 inches from the furthest end of the torque transmission coil, wherein the diameter of the closest concentric grinding drill is equal to the diameter of the furthest concentric grinding drill, and wherein the diameters of the closest concentric grinding drill and the furthest concentric grinding drill are smaller than the diameter of the middle eccentric grinding drill.

21. A rotary cutting device for removing stenotic lesion material from a patient's foot artery or coronary artery, the device comprising: A slender, flexible drive shaft that defines a longitudinal axis and includes a torque transmission coil of one or more filaments spirally wound around the longitudinal axis from distal to proximal along the filament winding direction; A series of grinding drills are fixedly mounted to the distal portion of the torque transmission coil. The series of grinding drills has a maximum drill diameter of no more than 1.25 mm. The intermediate grinding drill is an eccentric grinding drill whose center of mass is offset from the longitudinal axis, thereby running in a rotational direction opposite to the winding direction of the filament. The proximal grinding drill and the distal grinding drill each have a center of mass coaxial with the longitudinal axis.

22. The rotary cutting device according to claim 21, wherein, The diameter of the proximal grinding drill is equal to the diameter of the distal grinding drill.

23. The rotary cutting device according to claim 22, wherein, The diameters of the proximal grinding drill and the distal grinding drill are smaller than the diameter of the intermediate grinding drill.

24. The rotary cutting device according to claim 21, wherein, The diameter of the intermediate grinding drill is 1.25 mm, and the diameter of each of the proximal grinding drill and the distal grinding drill is 1.1 mm.

25. The rotary cutting device according to claim 21, wherein, Each of the series of grinding drills is spherical.

26. The rotary cutting device according to claim 21, further comprising a concentric end member positioned distal to the grinding drill.

27. A rotary cutting system, comprising: A torque transmission coil of one or more filaments, the one or more filaments being spirally wound from distal to proximal along the filament winding direction to define the coil diameter and the drive shaft axis; A series of grinding drills, fixedly mounted to the distal portion of the torque transmission coil, having a maximum drill diameter not exceeding 1.25 mm, comprising: a distal concentric grinding drill, coaxially mounted to the distal end of the torque transmission coil; a proximal concentric grinding drill, the same size as the distal concentric grinding drill, coaxially mounted to the torque transmission coil at a distance not exceeding 0.5 inches from the distal end; and a central eccentric grinding drill, larger than both the distal and proximal concentric grinding drills, mounted to the torque transmission coil with its center of mass offset from the drive shaft axis; and... A rotary cutting handle assembly, which is coupled to the proximal end of the torque transmission coil and houses an electric motor configured to drive the series of grinding drills to rotate about the drive shaft axis in a rotational direction in response to user input at the actuator of the rotary cutting handle assembly.

28. The rotary cutting system of claim 27 further includes a sheath extending over the torque transmission coil, and in the proximal position, the series of grinding drills are accommodated within the farthest end of the sheath.

29. The rotary cutting system according to claim 28, wherein, In response to a user input of distal longitudinal movement at the actuator, the series of grinding drills extends from the distal end of the sheath.

30. The rotary cutting system of claim 29 further includes a switch that controls power to an electric motor in response to the longitudinal position of the actuator.

31. The rotary cutting system according to claim 30, wherein, At the threshold longitudinal position of the actuator and on its distal side, power is supplied to the electric motor to rotate the series of grinding drills.

32. The rotary cutting system according to claim 31, wherein, At the threshold position and beyond, the series of abrasive drills are located at the farthest end of the sheath.

33. The rotary cutting system according to claim 30, wherein, Near the threshold position of the actuator, power to the electric motor is cut off to prevent the series of grinding drills from rotating.

34. The rotary cutting system according to claim 33, wherein, Near the threshold position, at least one of the series of grinding drills is housed within the sheath.

35. The rotary cutting system according to claim 27, wherein, The diameter of the proximal grinding drill is equal to the diameter of the distal grinding drill.

36. The rotary cutting system according to claim 35, wherein, The diameters of the proximal grinding drill and the distal grinding drill are smaller than the diameter of the intermediate grinding drill.

37. The rotary cutting system according to claim 35, wherein, The diameter of the intermediate grinding drill is 1.25 mm, and the diameter of each of the proximal grinding drill and the distal grinding drill is 1.1 mm.

38. The rotary cutting system according to claim 35, wherein, Each of the series of grinding drills is spherical.

39. The rotary cutting system according to claim 27, wherein, The series of grinding drills rotates in a direction opposite to the direction of the filament winding.

40. The rotary cutting system according to claim 27, wherein, Both the proximal and distal grinding drills have a center of mass coaxial with the drive shaft axis.

41. A method for rotary cutting in the foot artery below the ankle, comprising: The torque transmission coil of the rotary cutting device is advanced on the guide wire and into the foot artery below the ankle, such that at least one abrasive drill installed at the distal portion of the torque transmission coil approaches the stenotic lesion within the foot artery. Retract the sheath located on the at least one abrasive drill until the at least one abrasive drill is exposed within the foot artery; as well as The torque transmission coil of the rotary cutting device is rotated, causing the at least one grinding drill mounted on the torque transmission coil to grind the stenotic lesion within the foot artery.

42. A method for rotary cutting in a branch coronary artery of the heart, comprising: The torque transmission coil of the rotary cutting device is advanced on the guidewire and into the coronary branch artery of the heart, such that at least one abrasive drill, which is mounted to the distal portion of the torque transmission coil, approaches the stenotic lesion within the coronary branch artery. Retract the sheath located on the at least one grinding drill until the at least one grinding drill is exposed within the coronary branch artery; as well as The torque transmission coil of the rotary cutting device is rotated, causing the at least one abrasive drill mounted on the torque transmission coil to abrade the stenotic lesion within the coronary branch artery.

43. A rotary cutting device for removing stenotic lesion material from a patient's foot artery or coronary artery, the device comprising: A slender, flexible drive shaft that defines a longitudinal axis and includes a torque transmission coil of one or more filaments spirally wound around the longitudinal axis from distal to proximal along the filament winding direction; A series of grinding drills are fixedly mounted to the distal portion of the torque transmission coil, with a maximum drill diameter of no more than 1.25 mm, wherein at least one grinding drill is an eccentric grinding drill whose center of mass is offset from the longitudinal axis, thereby running in a rotational direction opposite to that of the filament winding.

44. A method for rotary cutting in the foot artery below the ankle, comprising: The torque transmission coil of the rotary cutting device is advanced on the guide wire and into the foot artery below the ankle, such that at least one abrasive drill installed at the distal portion of the torque transmission coil approaches the stenotic lesion within the foot artery. as well as The torque transmission coil of the rotary cutting device is rotated, causing the at least one grinding drill mounted on the torque transmission coil to grind the stenotic lesion within the foot artery.

45. A method for rotary cutting in a branch coronary artery of the heart, comprising: The torque transmission coil of the rotary cutting device is advanced on the guidewire and into the coronary branch artery of the heart, such that at least one abrasive drill, which is mounted to the distal portion of the torque transmission coil, approaches the stenotic lesion within the coronary branch artery. as well as The torque transmission coil of the rotary cutting device is rotated, causing the at least one abrasive drill mounted on the torque transmission coil to abrade the stenotic lesion within the coronary branch artery.

46. ​​A rotary cutting device that can be introduced by French.

47. A navigable rotary cutting device for the foot artery ring.

48. A navigable cutting device for coronary artery branches.

49. A rotary cutting system, comprising: A torque transmission coil of one or more filaments, the one or more filaments being spirally wound from distal to proximal along the filament winding direction to define the coil diameter and the drive shaft axis; A series of grinding drills are fixedly mounted to the distal portion of the torque transmission coil, each of the grinding drills having an outer drill diameter such that the drill-to-coil diameter ratio of all the grinding drills along the torque transmission coil is 1.3 to 1.

7. as well as A rotary cutting handle assembly, which is coupled to the proximal end of the torque transmission coil and houses an electric motor configured to drive the series of grinding drills to rotate about the drive shaft axis in a rotational direction in response to user input at the actuator of the rotary cutting handle assembly.

Images