HK40107270A - Hybrid atherectomy devices - Google Patents

Description

Hybrid Atherosclerosis Removal Device

Cross-references to related applications

This application claims priority to U.S. Application No. 17/833,967, filed June 7, 2022, which claims the benefit of U.S. Provisional Application No. 63/197,970, filed June 7, 2021, the entire contents of each of which are incorporated herein by reference.

Background Technology

Technical Field

The teachings of this article generally relate to medical devices and methods, including devices and methods for performing atherosclerotic resection through soft and hard vascular plaques.

Description of existing technology

Background Technology

Atherosclerosis resection is a minimally invasive surgical procedure used to remove atherosclerotic plaque from blood vessels, serving as an alternative to angioplasty for treating arterial stenosis. Common applications include peripheral artery disease and coronary artery disease. While angioplasty and stenting push plaque into the vessel wall, atherosclerosis resection removes plaque from the vessel wall. Although atherosclerosis resection is typically used to remove plaque from arteries, it can also be used for venous and vascular bypass grafting, among other applications.

Compared to balloon angioplasty and stent placement, atherosclerosis resection offers an improvement, the latter being considered the traditional interventional procedure for treating atherosclerosis. In balloon angioplasty, a collapsed balloon is inserted into the blood vessel and inflated, pushing the plaque against the vessel wall. A stent is then placed to hold the plaque in place, maintaining the integrity of the vessel lumen. However, this traditional treatment stretches the artery and induces scar tissue formation, and stent placement can also cut arterial tissue and induce scar tissue formation. Scar tissue formation can lead to restenosis. Furthermore, balloon angioplasty can tear the vessel wall. Because atherosclerosis resection widens the lumen by removing plaque rather than stretching the vessel, it reduces the risk of vascular injury, such as vessel rupture that could lead to increased restenosis.

Unfortunately, the most advanced atherosclerosis resection devices in the field are limited in performance. For example, current devices with rotary blades cannot effectively handle various types of soft plaques, fibrous plaques, and calcified plaques. They either fail to cut all types of plaques or break them down into large pieces that remain in the arterial bed as emboli, blocking downstream vessels. Because plaques are composed of fat, cholesterol, calcium, fibrous connective tissue, and other substances in the body, they vary greatly, mainly falling into four different tissue types: calcified hard, necrotic soft, fibrotic, and a mixture thereof. Calcified plaques can be as hard as bone; fatty plaques are usually softer; fibrotic plaques are typically viscoelastic, stretchy yet hard, making them difficult to cut. Some state-of-the-art devices have burr heads that can grind away hard plaques but cannot cut soft or viscoelastic plaques. Worse still, these burr heads can loosen debris, forming dangerous emboli. Some state-of-the-art devices have a sharp blade that can be deflected to one side of the vessel for eccentric cutting, which is desirable, but the amount of deflection cannot be effectively controlled. In addition, some state-of-the-art devices have a "nose cone" that prevents the device from having enough propulsion to reach the cutting blade, thus preventing the cutting blade from cutting into the lesion.

However, most importantly, patients with "narrow" or "hard" lesions are currently ineligible for balloon, stent, or atherosclerotic resection devices. These lesions refer to occlusions with only a very small opening or no opening at all, making it difficult, if not impossible, for a guidewire to pass through, let alone a balloon or stent. For example, a 0.5 mm opening might allow a guidewire to pass, but the smallest stent might be only 1.0 mm, and the smallest balloon might be only 0.75 mm, neither of which can be used to treat hard, small lesions. Moreover, as mentioned above, even if a guidewire can pass through the opening, current atherosclerotic resection devices struggle to remove the plaque. In cases of complete occlusion, the problem is even more severe.

Therefore, technicians will appreciate an atherosclerosis resection device capable of (i) effectively cutting and removing four different types of plaque tissue (i.e., calcification and hardening, necrosis and softening, fibrosis, and combinations thereof); (ii) presenting the vascular lumen with minimal plaque burden; (iii) safely collecting and removing plaque particles to avoid embolus release; and (iv) effectively treating the vessel while reducing the risk of vascular damage leading to increased restenosis. Furthermore, skilled technicians will certainly appreciate having an atherosclerosis resection device that (v) can handle these narrow or hard lesions. In some embodiments, the atherosclerosis cutters and devices taught herein may be referred to as “hybrid” cutters and devices because their ability to cut combinations of soft and hard plaques will be highly appreciated by skilled technicians.

Summary of the Invention

This invention provides an atherosclerosis resection device and its method of use, namely (i) a device and method capable of effectively cutting and removing four different types of plaque tissue, namely calcification and hardening, necrosis and softening, fibrosis, and combinations thereof; (ii) capable of presenting the vascular lumen with minimal plaque burden; (iii) capable of safely collecting and removing plaque particles without releasing emboli; (iv) capable of effectively treating blood vessels and reducing the risk of vascular damage leading to increased restenosis; and importantly, (v) capable of treating stenosis or tough lesions with almost no luminal opening. The atherosclerosis resection device described herein may be telescopic, self-propelled, laterally pushed, or a combination thereof.

In some embodiments, the atherosclerosis resection device is a telescopic atherosclerosis resection device. In these embodiments, the device may have a distal end, a proximal end, a long axis, and a guidewire lumen extending through the device along the long axis. The device may include a flexible sheath having an outer diameter and a sheath lumen; a cutter having a proximal end, a distal end, and a body with multiple helical grooves, the distal end having multiple cutting lips, a cutter cavity, and a clearance diameter; and a drive assembly. The drive assembly may have a flexible drive shaft including an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity, the distal end of the flexible drive shaft being fixedly connected to the cutter, wherein the flexible drive shaft and the cavity of the flexible sheath are rotatably translatable. The drive assembly may also have a volumetric pump that initiates pumping near the helical grooves at the distal end of the drive shaft and the proximal end of the cutter. Moreover, in these embodiments, the clearance diameter of the cutter may be greater than the outer diameter of the flexible drive shaft; the flexible drive shaft may be longer than the flexible sheath to allow reversible extension and retraction of the drive assembly from the cavity of the flexible sheath at the distal end of the flexible sheath; and the guidewire lumen may include a cutter cavity and a drive shaft cavity.

In some embodiments, the clearing diameter of the cutter can be larger than the outer diameter of the flexible sheath. Furthermore, in some embodiments, the volumetric pump can be a screw pump connected to the outer surface of the drive shaft, with the distal end of the screw pump adjacent to the helical groove at the proximal end of the cutter.

In some embodiments, the telescopic atherosclerosis resection device may be self-driven. For example, the screw pump may extend beyond the flexible sheath and may be exposed to contact the lumen when the resection device is used intravascularly. In some embodiments, the screw pump may be a right-handed screw when the cutter rotates in a right-hand direction; while in other embodiments, the screw pump may be a left-handed screw when the cutter rotates in a left-hand direction.

In some embodiments, the telescopic atherosclerosis resection device may further include a reversibly expandable lateral pushing member located at the distal end of the flexible sheath. In some embodiments, the telescopic atherosclerosis resection device may further include a reversibly deployable lateral pushing member located at the distal end of the flexible sheath, the lateral pushing member having a proximal end, a distal end, a folded state, and an deployed state, the proximal end having an operative connection to the flexible sheath, and the distal end having an operative connection to the cutter. The operative connection to the flexible sheath and the operative connection to the cutter may be configured to receive the following axial forces: (i) an axial force applied from the cutter to the flexible sheath along the axis of the flexible drive shaft; and (ii) a collapse and expansion axial force transmitted through the lateral pushing member during the reversible extension and retraction of the flexible drive shaft from the flexible sheath. Furthermore, the operative connection to the cutter may be configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pushing member during operation of the atherosclerosis resection device.

In some embodiments, the atherosclerosis resection device is a self-driven atherosclerosis resection device. In these embodiments, the device may have a distal end, a proximal end, a long axis, and a guidewire lumen extending through the device along the long axis. The device may include a flexible sheath having an outer diameter and a sheath lumen; a cutter having a proximal end, a distal end, and a body with multiple helical grooves, the distal end having multiple cutting lips, a cutter lumen, and a clearance diameter; and a drive assembly. The drive assembly may have a flexible drive shaft including a shaft, a proximal end, a distal end, an outer surface, and a drive shaft lumen, the distal end of the flexible drive shaft being fixedly connected to the cutter, wherein the flexible drive shaft is rotatably and translatably oriented relative to the lumen of the flexible sheath. The drive assembly may also have a screw pump connected to the outer surface of the drive shaft and adjacent to the helical grooves of the proximal end of the cutter, the screw pump including a drive screw portion. In some embodiments, the drive screw portion may extend beyond the flexible sheath and may be exposed to contact the lumen of the vessel when the atherosclerosis resection device is used intravascularly. In some embodiments, the drive screw portion may be a right-handed screw when the cutter rotates in a right-hand direction; while in other embodiments, the drive screw portion may be a left-handed screw when the cutter rotates in a left-hand direction. In these embodiments, the clearing diameter of the cutter may be larger than the outer diameter of the flexible drive shaft; and the guide wire cavity may include a cutter cavity and a drive shaft cavity.

In some embodiments, the cutting diameter of the self-driven atherosclerosis resection device can be larger than the outer diameter of the flexible sheath. Furthermore, in some embodiments, the drive screw portion can be the distal portion of a screw pump.

In some embodiments, the flexible drive shaft of the self-driven atherosclerosis resection device may be longer than the flexible sheath so that the drive assembly can be reversibly extended and retracted from the lumen of the flexible sheath at the distal end of the flexible sheath.

In some embodiments, the self-driven atherosclerosis resection device may further include a reversibly deployable lateral pusher located at the distal end of a flexible sheath. In some embodiments, the lateral pusher may have a proximal end, a distal end, a folded state, and an deployed state, with the proximal end having an operative connection to the flexible sheath and the distal end having an operative connection to a cutter. The operative connection to the flexible sheath and the operative connection to the cutter may be configured to receive axial forces: (i) an axial force applied from the cutter to the flexible sheath along the axis of the flexible drive shaft; and (ii) an axial force transmitted through the lateral pusher during the collapse and expansion of the flexible drive shaft during reversible extension and retraction from the flexible sheath. Furthermore, in some embodiments, the operative connection to the cutter may be configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pusher during operation of the atherosclerosis resection device.

In some embodiments, the atherosclerosis resection device is a lateral atherosclerosis resection device. In these embodiments, the device may have a distal end, a proximal end, a long axis, and a guidewire lumen extending through the device along the long axis. The device may include a flexible sheath having an outer diameter and a sheath cavity, a cutter having a proximal end, a distal end, and a body with multiple helical grooves, a point having multiple incisions at the distal end, a cutter cavity, and a clearance diameter; and a drive assembly. The drive assembly may have a flexible drive shaft including an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity, the distal end of the flexible drive shaft being fixedly connected to the cutter, wherein the flexible drive shaft is rotatably and translatably oriented relative to the cavity of the flexible sheath. The drive assembly may also have a volumetric pump that initiates pumping near the helical grooves at the distal end of the drive shaft and the proximal end of the cutter. Furthermore, the lateral atherosclerosis resection device may also have a reversibly expandable lateral drive component mounted at the distal end of the flexible sheath. In these embodiments, the clearance diameter of the cutter may be larger than the outer diameter of the flexible drive shaft; and the guidewire lumen may include the cutter cavity and the drive shaft cavity.

In some embodiments, the cutting diameter can be larger than the outer diameter of the flexible sheath.

In some embodiments, the lateral pusher may have a proximal end, a distal end, a folded state, and an unfolded state, with the proximal end operably connected to a flexible sheath and the distal end operably connected to a cutter. In some embodiments, the operable connection to the flexible sheath and the operable connection to the cutter may be configured to receive axial forces: (i) an axial force applied from the cutter to the flexible sheath along the axis of the flexible drive shaft; and (ii) an axial force transmitted through the lateral pusher during the reversible collapse and expansion of the flexible drive shaft from the flexible sheath. Moreover, in some embodiments, the operable connection to the cutter may be configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pusher during operation of the atherosclerosis resection device.

In some embodiments, the flexible drive shaft of the laterally actuated atherosclerosis resection device may be longer than the flexible sheath to allow reversible extension and retraction of the drive assembly from the lumen of the flexible sheath at its distal end. Furthermore, in some embodiments, the laterally actuated atherosclerosis resection device may include a drive screw connected to the distal outer surface of the drive shaft and adjacent to the screw pump at its distal end. The drive screw may extend beyond the flexible sheath and may be exposed to contact the lumen when the atherosclerosis resection device is used intravascularly. In some embodiments, the drive screw may be a right-handed screw when the cutter rotates in a right-hand direction; and in other embodiments, the drive screw may be a left-handed screw when the cutter rotates in a left-hand direction.

A system is also provided. In some embodiments, any of the atherosclerosis resection devices taught herein may be a system comprising an atherosclerosis resection device and a guidewire.

Methods for removing atherosclerosis in a subject using any of the atherosclerosis resection devices taught herein are provided. In some embodiments, these methods may include creating an entry point in the lumen of the subject's blood vessel; inserting the atherosclerosis resection device into the lumen; extending a flexible drive shaft; cutting plaque from the lumen using the cutter of the atherosclerosis resection device; discharging the cut plaque from the lumen using a volumetric pump; and removing the atherosclerosis resection device from the lumen of the subject.

In some embodiments, the method may include creating an entry point in the lumen of a subject's blood vessel; inserting an atherosclerosis resection device into the lumen of the blood vessel; driving the atherosclerosis resection device through the lumen of the blood vessel with an exposed drive screw; cutting plaque from the lumen of the blood vessel with the cutter of the atherosclerosis resection device; discharging the cut plaque from the lumen of the blood vessel with a volumetric pump; and removing the atherosclerosis resection device from the lumen of the subject's blood vessel.

Similarly, in some embodiments, the method may include creating an entry point in the lumen of a subject's blood vessel; inserting an atherosclerosis resection device into the lumen; laterally pushing the distal portion of the atherosclerosis resection device into the lumen, the pushing including an expanding lateral pushing component; cutting plaque from within the lumen using the cutter of the atherosclerosis resection device; draining the cut plaque from within the lumen using a volumetric pump; and removing the atherosclerosis resection device from the subject's blood vessel.

In some embodiments, a hybrid atherosclerotic cutter for cutting a combination of soft and hard plaques is provided. The cutter may include a proximal end, a distal end, and a longitudinal axis, and a cutting length defined by the distance from the proximal end to the distal end along the longitudinal axis. The cutter may have a radius at the distal end, the radius having an inner inflection point and an outer inflection point; in some embodiments, the cutter may have a first primary cutting edge and a second primary cutting edge, the first and second primary cutting edges extending helically from the distal end to the proximal end along the radius. The cutter may have a first helical groove and a second helical groove, each having a helical angle and forming a helical channel opening at the distal and proximal ends. The cutter may also have a cutting diameter, the maximum distance between the first and second primary cutting edges, measured as a normal to the longitudinal axis. The cutter may further include a core having a core diameter, a distal end, and a proximal end; wherein the distal end of the core is configured with a first plurality of secondary cutting surfaces forming a first secondary cutting edge at the distal end of the first helical groove; and a second plurality of secondary cutting surfaces forming a second secondary cutting edge at the distal end of the second helical groove. In addition, the cutter can also have a lumen for passing a guidewire. This type of cutter is ideal for effectively cutting both soft and hard plaques in blood vessels.

Those skilled in the art will understand that the radius of the distal end of the cutter can be any desired shape. In some embodiments, the radius is the bulbous nose radius. In some embodiments, the radius is the corner radius. In some embodiments, the radius is equal to half the diameter of the cutter.

Those skilled in the art will understand that each groove is helical and can have a helix of any desired angle; therefore, a combination of grooves can have the same helix angle or a combination of helix angles. Furthermore, the grooves of the cutter can have the same angle or different angles compared to one or more other grooves. For example, a technician can select a cutter with this structure to achieve a smoother cutting effect. Moreover, in some embodiments, the flute angle can be constant or variable. For example, a technician can select a "variable helix," or a variable flute angle between grooves, to suit materials that may be more resistant to cutting, and perhaps also improve cutting efficiency. A helix angle greater than 45° is considered a "high angle," which removes material more effectively from the cutting site and leaves a smoother cut surface, while reducing tissue packaging and tissue recutting; while a helix angle less than 40° is considered a "low angle," which removes larger pieces of material in a given cutting time and leaves a rougher cut surface, while potentially causing tissue packaging and tissue recutting in some applications. In some embodiments, the grooves can have high helix angles; while in other embodiments, the grooves can have low helix angles.

Those skilled in the art will recognize that the cutter includes secondary facets for generating secondary cutting edges. In some embodiments, the distal end of the core may be configured with a plurality of first secondary facets forming a first secondary cutting edge at the distal end of a first helical groove; in some embodiments, the distal end of the core may be configured with a plurality of second secondary facets forming a second secondary cutting edge at the distal end of a second helical groove.

This embodiment also includes a cutter with primary cutting surfaces to improve the cutting effect of the primary cutting edge on tissue. In some embodiments, the distal end of the core further includes a plurality of first primary cutting surfaces located distal to the first primary cutting edge; and in some embodiments, the distal end of the core further includes a plurality of second primary cutting surfaces located distal to the second primary cutting edge. In some embodiments, the plurality of first primary cutting surfaces may be configured to extend the extent of the first primary cutting edge; similarly, the plurality of second primary cutting surfaces may be configured to extend the extent of the second primary cutting edge.

In some embodiments, the cutter may have a third primary cutting edge extending radially from a distal end to a proximal end, and a third helical groove having a helical angle and forming a helical channel opening at both the distal and proximal ends. In some embodiments, the core may further be configured with a plurality of third secondary cutting faces forming a third secondary cutting edge at the distal end of the third helical groove. Similarly, the core may further be configured with a plurality of third primary cutting faces at the distal end of the third primary cutting edge, the plurality of third primary cutting faces being configured to extend the distal extent of the third primary cutting edge.

In some embodiments, the cutter may have a third primary cutting edge extending radially from a distal end to a proximal end; a fourth primary cutting edge extending radially from a distal end to a proximal end; a third helical groove having a helical angle and forming a helical channel opening at both the distal and proximal ends; and a fourth helical groove having a helical angle and forming a helical channel opening at both the distal and proximal ends. In some embodiments, the core may be further configured such that the distal end of the third helical groove forms a plurality of third secondary cutting surfaces of a third secondary cutting edge; and the distal end of the third helical groove forms a plurality of fourth secondary cutting surfaces of a fourth secondary cutting edge. Similarly, the core may be further configured such that the distal end of the third primary cutting edge has a plurality of third primary cutting edges configured to extend the distal extent of the third primary cutting edge; and the distal end of the fourth primary cutting edge has a plurality of fourth primary cutting edges configured to extend the distal extent of the fourth primary cutting edge.

Those skilled in the art will understand that any atherosclerosis resection device taught herein can include any of the blades taught herein. In some embodiments, the atherosclerosis resection device includes a blade taught herein having a clearing diameter; a distal end, a proximal end, a long axis, and a guidewire lumen extending through the device along the long axis; a flexible sheath having an outer diameter and a sheath cavity; and a drive assembly having a flexible drive shaft including an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity, the distal end of the flexible drive shaft being fixedly connected to the blade, wherein the flexible drive shaft is rotatably and translatably oriented relative to the cavity of the flexible sheath, and the drive assembly further having a volumetric pump that initiates pumping near a helical groove at the distal end of the drive shaft and the proximal end of the blade. In these embodiments, the clearing diameter of the blade may be greater than the outer diameter of the flexible sheath; the flexible drive shaft may be longer than the flexible sheath to allow reversible extension and retraction of the drive assembly from the cavity of the flexible sheath at the distal end of the flexible sheath; and the guidewire lumen may include a blade cavity and a drive shaft cavity.

In some embodiments, the atherosclerosis resection device includes a cutter as taught herein, the cutter having a clearing diameter; a distal end, a proximal end, a long axis, and a guidewire lumen extending through the device along the long axis; a flexible sheath having an outer diameter and a sheath cavity; a drive assembly having a flexible drive shaft including an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity, the distal end of the flexible drive shaft being fixedly connected to the cutter, wherein the flexible drive shaft is rotatably and translatably oriented relative to the cavity of the flexible sheath, the drive assembly further having a screw pump connected to the outer surface of the drive shaft and adjacent to a helical groove at the proximal end of the cutter, the screw pump including a drive screw portion; wherein the drive screw portion extends beyond the flexible sheath and is exposed within the lumen of the vessel for contact with the lumen of the vessel when the atherosclerosis resection device is used within the lumen of the vessel; and, when the cutter rotates in a right-hand direction, the drive screw portion is a right-handed screw; or, when the cutter rotates in a left-hand direction, the drive screw portion is a left-handed screw. In these embodiments, the clearing diameter of the cutter can be larger than the outer diameter of the flexible drive shaft; and the guide wire cavity can include a cutter cavity and a drive shaft cavity.

In some embodiments, the atherosclerosis resection device includes a cutter as taught herein, the cutter having a clearing diameter; a distal end, a proximal end, a long axis, and a guidewire lumen extending through the device along the long axis; a flexible sheath having an outer diameter and a sheath lumen; and a drive assembly having a flexible drive shaft including an axis, a proximal end, a distal end, an outer surface, and a drive shaft lumen, the distal end of the flexible drive shaft being fixedly connected to the cutter, wherein the flexible drive shaft is rotatably and translatably oriented relative to the lumen of the flexible sheath. The drive assembly also includes a volumetric pump that pumps from the distal end of the drive shaft and is adjacent to a helical groove at the proximal end of the cutter. Furthermore, the atherosclerosis resection device may also have a reversibly expanding lateral pushing member at the distal end of the flexible sheath, the lateral pushing member having a proximal end, a distal end, a collapsed state, and an expanded state, the proximal end being operably connected to the flexible sheath, and the distal end being operably connected to the cutter. In these embodiments, the clearing diameter of the cutter may be larger than the outer diameter of the flexible sheath; the guidewire lumen may include a cutter lumen and a drive shaft lumen. Furthermore, the operable connection with the flexible sheath and the operable connection with the cutter can be configured to receive axial forces: (i) applied from the cutter along the axial direction of the flexible drive shaft to the flexible sheath; (ii) transmitted via a lateral pushing member during the reversible extension and retraction of the flexible drive shaft from the flexible sheath; and the operable connection with the cutter can be configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pushing member during operation of the atherosclerosis resection device.

Technicians will also understand that any method of performing atherosclerosis resection may include the use of any atherosclerosis resection device and any of the cutting tools taught herein. Regardless of the atherosclerosis resection device used, these methods may include creating an entry point in the lumen of the subject's blood vessel; inserting the atherosclerosis resection device into the lumen; extending and retracting the flexible drive shaft; cutting the plaque from the lumen using the cutting tool of the atherosclerosis resection device; draining the cut plaque from the lumen using a volumetric pump; and removing the atherosclerosis resection device from the subject's lumen.

Attached Figure Description

Figures 1A-1C illustrate arterial anatomy, intimal plaque, and plaque resection methods according to certain embodiments.

Figures 2A and 2B illustrate a telescopic atherosclerosis resection device according to certain embodiments.

Figure 3 illustrates a self-driven telescopic atherosclerosis resection device according to some embodiments.

Figures 4A-4D illustrate a telescopic atherosclerosis resection device according to some embodiments, which may further include a reversibly expandable lateral push member located at the distal end of a flexible sheath, wherein expansion of the lateral push member results in a curve.

Figures 5A-5D illustrate compressible sleeves according to some embodiments, which can be used to increase the torsional stiffness of a lateral push member, wherein the expansion of the lateral push member results in a curve.

Figures 6A and 6B show other cutters that can be used according to certain embodiments.

Figures 7A-7C illustrate features of a cutter according to certain embodiments, including a primary cutting edge and a secondary cutting edge, a groove, a helix angle, and a guide wire cavity.

Figures 8A-8D illustrate the features of a cutter according to certain embodiments, including cutting length, radius, and cutting diameter.

Figures 9A-9C show perspective views, near-end views, and far-end views of the primary and secondary cutting edges according to some embodiments, as well as the primary and secondary cutting surfaces that improve the cutting structure of the cutter.

Figures 10A and 10B illustrate the mapping of primary and secondary cutting planes according to some embodiments and their relationship to primary and secondary cutting edges.

Figure 11 illustrates a method for performing atherosclerotic resection according to certain embodiments.

Figure 12 illustrates, in a diagram, a method for performing atherosclerotic resection according to certain embodiments.

Detailed Implementation

This invention provides an atherosclerosis resection device and its method of use, namely, the following device and method: (i) capable of effectively cutting and removing four different types of plaque tissue, namely calcification and hardness, necrosis and softness, fibrosis, and combinations thereof, including fibrocalcified tissue; (ii) capable of concentricizing the vascular lumen with minimal plaque burden; (iii) capable of safely self-collecting and removing plaque particles, avoiding emboli release; (iv) capable of effectively treating blood vessels, reducing the risk of vascular damage leading to increased restenosis. Moreover, importantly, a skilled technician will certainly appreciate such an atherosclerosis resection device, and surprisingly, (v) it can also treat stenosis or hard lesions with almost no luminal opening. In some embodiments, the atherosclerosis cutter and device taught herein may be referred to as a "hybrid" cutter and device because they are capable of cutting combinations of soft and hard plaques, a capability that will be highly appreciated by a skilled technician. The atherosclerosis resection device described herein may be telescopic, self-driven, side-push, or a combination thereof. For example, the device presented herein can form concentric chambers with minimal plaque burden (<30% of vessel diameter) while avoiding damage to the vessel wall and reducing embolism.

Figures 1A-1C illustrate arterial anatomy, intimal plaque, and plaque removal methods according to certain embodiments. Figure 1A shows the anatomical structure of artery 100. The anatomy of arteries can vary depending on their size, but they share common characteristics. They transport oxygenated blood from the heart to smaller arterial vessels. The outermost layer is the adventitia, or pre-lamina, composed of collagen fibers. The largest arteries, such as the aorta, also have vasa vasorum, or small vessels that supply oxygen to larger vessels. The next layer is the media, composed of smooth muscle, collagen fibers, and elastic fibers. The next layer is the intima, which is also elastic, with endothelial cells supported by a layer of collagen. These layers surround the lumen of the vessel, which is the wall where undesirable plaques form, and these plaques can be removed using the atherosclerotic resection device taught herein. Figure 1B shows plaque 110 deposited on the wall of arterial lumen 105.

Those skilled in the art will understand that guidewires can be used to locate lesion areas or target areas within a blood vessel. Furthermore, guidewires can also be used to guide the atherosclerosis resection device (i.e., the cutter) described herein to the target area. In some embodiments, the guidewire lumen may include a cutter lumen and a drive shaft lumen. In some embodiments, the guidewire lumen diameter may range from 0.01 to 0.20 inches, 0.01 to 0.18 inches, 0.01 to 0.15 inches, 0.01 to 0.10 inches, or any range in some embodiments. In some embodiments, the guidewire lumen diameter may be between 0.01 and 0.14 inches. In some embodiments, the guidewire lumen diameter is any diameter of 0.01 inches (0.254 mm), 0.02 inches (0.508 mm), 0.04 inches (1.016 mm), 0.06 inches (1.524 mm), 0.08 inches (2.032 mm), 0.10 inches (2.540 mm), 0.12 inches (3.048 mm), 0.14 inches (3.556 mm), 0.16 inches (4.064 mm), 0.18 inches (4.572 mm), 0.20 inches (5.080 mm), or in increments of 0.01 inches (0.254 mm).

Figure 1C is a flowchart of an atherosclerotic resection method 150, which can be used with the atherosclerotic resection device taught herein to remove plaque from an artery. A guidewire is passed through a guiding catheter and through a vascular obstruction 174 caused by plaque in the target area of the artery. After the guidewire passes through the obstruction, the atherosclerotic resection device is passed through the obstruction 176 over the guidewire. The atherosclerotic resection device then cuts and removes the plaque in the target area at the appropriate location, thereby treating the artery and removing the obstruction 178. At this point, a stent may be optionally inserted in the target area to help maintain the newly opened opening 180 in the lumen. After the procedure is completed, the atherosclerotic resection device and guidewire 182 are removed from the patient.

Generally, an atherosclerosis resection device may include a cutter or cutting head connected to a drive shaft that rotates the cutter within a sheath. In some embodiments, the sheath may be interchangeably referred to as a "hose"; in some embodiments, the drive shaft may be referred to as a "torque shaft". In some embodiments, the cutter may be retractable from the sheath; in some embodiments, it may be reversibly retractable from the sheath. In some embodiments, the cutter may extend or retract from the sheath as needed. For example, in some embodiments, the cutter may extend or retract from the sheath end on the drive shaft by 10 mm to 500 mm. In some embodiments, the cutter may extend or retract from approximately 20 mm to approximately 200 mm, from approximately 30 mm to approximately 100 mm, from approximately 40 mm to approximately 80 mm, approximately 60 mm, or any range thereof in 1 mm increments. In some embodiments, the cutter can extend or retract by approximately 10 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, 100 mm, 110 mm, 120 mm, 130 mm, 140 mm, 150 mm, 160 mm, 170 mm, 180 mm, 190 mm, 200 mm, 300 mm, 400 mm, 500 mm, or any number or range in increments of 1 mm. Through extension and retraction, the distal portion of the cutter and drive shaft can advance in front of the sheath, during which engagement between the cutter and plaque tissue can be improved. Furthermore, keeping the sheath stationary while allowing the cutter to move in front of the sheath makes the sheath resistant to drill-through. In some methods, extension and retraction may be the sole step in removing plaque from the blood vessel. In some embodiments, extension and retraction provide an initial cutting path to facilitate subsequent, more targeted, eccentric cutting.

Figures 2A and 2B illustrate a telescopic atherosclerosis resection device according to some embodiments. In these embodiments, the atherosclerosis resection device 200 may include a distal portion having a distal end 202, a proximal portion having a proximal end (not shown), a long axis having a central axis 205, and a guidewire lumen extending through a guidewire 210 of the device along the direction of the central axis 205. For ease of observation, Figure 2A shows the general direction from proximal to distal and from distal to proximal. The device may include a flexible sheath 215 having a proximal portion (not shown) with a proximal end, a distal portion 217 with a distal end, an outer diameter 219, and a sheath lumen 221; a drive shaft 250; a cutter 230 having a proximal portion 232 with a proximal end, a distal portion 234 with a distal end, and a body 236, with a plurality of helical grooves 238 between cutter blades 240. The distal end 234 may have a plurality of cutting lips on the cutter blades 240, and in some embodiments, the distal end 234 may have a point. The cutter may have a cutting cavity 242 and a cleaning diameter 260.

The drive shaft can be manufactured using any structure known to those skilled in the art to meet requirements such as axial stiffness, flexural stiffness, and torsional stiffness. For example, in some embodiments, the drive shaft includes a distal end and a proximal end, wherein the distal end is connected or secured to the cutter, and the proximal end is connected to a rotatable element, such as a gear connected to a motor or a gear connected to the motor itself. The drive shaft may, in turn, be driven by a motor in the handle. The drive shaft can be made of metal braid and/or one or more metal coils, with one or more portions of the drive shaft embedded in a polymer. In some embodiments, the polymer may include PEBAX, polyurethane, polyethylene, fluoropolymers, parylene, polyimide, PEEK, PET, or combinations thereof. In some variations, the drive shaft may include a rigid material, such as plastic, made flexible by incorporating helical protrusions or grooves. During the procedure, the motor drives the gears to rotate the drive shaft and the cutter to cut tissue in the target lesion.

Those skilled in the art will understand that the "clearance diameter" of a blood vessel can be used to describe the diameter of the lumen after the cutting portion of the atherosclerosis resection device has passed through it. Because blood vessels are typically elastic, the clearance diameter 260 of the lumen may or may not be equal to the diameter of the cutting blade 230. The clearance diameter 260 of the cutting blade 230 may be larger than the outer diameter of the flexible drive shaft 250. In some embodiments, the clearance diameter of the cutting blade may be larger than the outer diameter of the flexible sheath. In some embodiments, the net diameter 260 of the lumen is smaller than the diameter of the body of the cutting blade 230.

Table 1 lists examples of arterial lumen diameters in millimeters, for example, starting from the aorta and extending down the human leg. Peripheral vascular disease of the leg is an example of a condition that can be treated using the atherosclerotic resection device taught in this paper.

Table 1. Examples of arterial lumen diameters in millimeters.

The superior femoral artery is located in the middle of the thigh, typically 5 to 7 millimeters (0.2 to 0.25 inches) in diameter. As the artery descends below the knee, the popliteal artery typically has a diameter of 4 to 4.5 millimeters (0.157 to 0.177 inches), decreasing to approximately 3.5 millimeters (0.137 inches) as the subject moves towards the direction of their foot. The popliteal artery then branches again into the anterior tibial artery and the tibioperoneal trunk, further decreasing in diameter to approximately 3.0 millimeters, and then to approximately 2.5 millimeters (0.118 to 0.098 inches). The tibioperoneal trunk further subdivides into the posterior tibial arteries and the peroneal arteries, decreasing in diameter to approximately 2.0 millimeters (0.078 inches). Generally, the diameter of peripheral arteries in the leg typically ranges from about 2 mm to about 7 mm. Any vessel may contain plaque and could become a target area for the atherosclerosis resection device discussed in this article. For example, coronary arteries are approximately 3 mm in size and range in diameter from 2.5 mm to 4.5 mm, making them a potential target area for the coronary artery resection device discussed in this article.

While simply increasing the diameter of the scalpel to cut larger blood vessels may seem reasonable, skilled technicians will recognize that the scalpel diameter can also be limited by physical complications arising from the patient's anatomy. For example, complications may occur during the procedure due to bleeding from the arterial puncture site, vessel tortuosity, changes in vessel size, etc. In some embodiments, the scalpel diameter can range from about 0.70 mm to about 2.20 mm; in some embodiments, the diameter can range from 1.00 mm to 2.20 mm; in some embodiments, the diameter can range from 1.20 mm to 2.20 mm; in some embodiments, the diameter can range from 1.40 mm to 2.20 mm; in some embodiments, the diameter can range from 1.50 mm to 2.20 mm, or any range therein in increments of 0.10 mm. In some embodiments, the diameter of the cutter can be about 0.90 mm, 1.00 mm, 1.10 mm, 1.20 mm, 1.30 mm, 1.40 mm, 1.50 mm, 1.60 mm, 1.70 mm, 1.80 mm, 1.90 mm, 2.00 mm, 2.10 mm, 2.20 mm, 2.30 mm, or any diameter or range thereof in increments of 0.05 mm. This is important because the diameter of the vessel lumen can be very small or very large; a vessel with a diameter of 1.00 mm is narrow to the cutter, while vessels with a diameter exceeding about 2.30 mm become larger than the cutter in some embodiments. Those skilled in the art will recognize that eccentric cutting can cut areas larger than the diameter of the cutter assembly without adding or replacing the cutter with other, larger tools for removal.

A skilled technician will also recognize that the length of the cutter must be limited to achieve the required maneuverability. The technician will also recognize that the cutter size can be any size known in the art as suitable for a particular process. In some embodiments, the cutter length can range from about 0.50 mm to about 3.00 mm, from about 0.60 mm to about 2.80 mm, from about 0.80 mm to about 2.60 mm, from about 1.00 mm to about 2.40 mm, from about 1.00 mm to about 2.20 mm, from about 1.00 mm to about 2.00 mm, from about 1.20 mm to about 1.80 mm, or any range therein in increments of 0.10 mm.

The atherosclerosis resection device 200 also includes a drive assembly for driving the cutter 230. The drive assembly may have a flexible drive shaft 250 including a long shaft with a central axis that may coincide with the central axis 205 of the atherosclerosis resection device 200. The flexible drive shaft 250 may further have a proximal portion with a proximal end (not shown), a distal portion with a distal end 252, an outer surface 254, and a drive shaft cavity 256, the distal end 252 of which is fixedly connected to the cutter 230. The flexible drive shaft 250 is rotatably translatable with respect to the lumen 221 of the flexible sheath 215. The drive shaft 250 may extend to a drive engine located outside the body receiving the atherosclerosis resection, the drive engine being powered by an electric motor in some embodiments or by an air compressor in others, and the drive shaft 250 may be operatively connected to a handle (not shown) at the proximal end of the atherosclerosis resection device for user control. The drive assembly may also include a volumetric pump that draws air from the vicinity of the helical groove 238 at the distal end of the drive shaft 250 and the proximal end of the cutter 230. In some embodiments, the volumetric pump extends from the distal end of the drive shaft 250 to the proximal end of the drive shaft 250 to pump cut arterial plaque fragments from the blood vessel.

Technicians will understand that a subject is a patient undergoing atherosclerosis resection. The terms "subject" and "patient" are used interchangeably and refer to animals, such as mammals, including but not limited to non-primates such as cattle, pigs, horses, cats, dogs, rabbits, rats, and mice; and primates such as monkeys or humans. In some embodiments, a subject may also be a corpse or part of a corpse.

The flexible drive shaft 250 may be longer than the flexible sheath 215 so that the drive assembly 270 can be reversibly extended and retracted from the lumen 221 of the flexible sheath 215 at its distal end 252. The guidewire lumen may include a cutter lumen 242 and a drive shaft lumen 256. While the flexural stiffness of the drive shaft 250 remains constant in the folded and unfolded states of the device, the flexural motion 290 increases when the drive shaft is extended and retracted from the flexible sheath 215. Therefore, the amount of flexural motion 290 available in FIG. 2A is greater than that in FIG. 2B, and the ease of flexural motion 290 in FIG. 2A is greater than that in FIG. 2B because the length of the extended and retracted drive shaft in FIG. 2A is greater than the length of the exposed drive shaft in FIG. 2B. We find that as the amount and ease of flexural motion 290 resulting from the extension and retraction 270 increases, the ease with which the cutter 230 passes through the artery also increases.

In some embodiments, the cutter can be operatively connected to the drive shaft using a friction joint, such that the drive shaft can slide on the base of the cutter when engaging with a plaque and meeting a maximum torque limit. Furthermore, in some embodiments, the volumetric pump can be a screw pump 280, also referred to in some embodiments as an Archimedes screw. The volumetric pump can be connected to the outer surface 254 of the drive shaft 250, with the distal end of the screw pump adjacent to the helical groove 238 of the proximal end 232 of the cutter 230 to deliver the cut plaque from the cutter in a distal-to-proximal direction to the proximal end of the atherosclerosis resection device for removal of the cut plaque from the subject.

Figure 3 illustrates a self-driven telescopic atherosclerosis resection device according to certain embodiments. The atherosclerosis resection device 300 may have a screw pump 380 operatively contacting a cutter 330, etc. The screw pump 380 may extend beyond a flexible sheath 315 and may be exposed to contact the vessel lumen wall (not shown) during intraluminal use of the vascular resection device, typically possibly contacting residual plaque on the lumen wall. In some embodiments, the screw pump 380 may be a right-handed screw (as shown) when the cutter 330 rotates in a right-hand direction 390; while in other embodiments, the screw pump 380 may be a left-handed screw (as shown) when the cutter 330 rotates in a left-hand direction (opposite to 390). Thus, a right-handed cutter may have a right-handed screw pump, and a left-handed cutter may have a left-handed screw pump, so that the screw pump can assist in driving the vascular resection device 300 through the vessel lumen along the guidewire 310 when cutting vascular plaque within the vessel lumen. Technicians will understand that self-driven devices can provide significant value because they can assist surgeons by reducing the force required, for example, during device manipulation. Self-drive can be complete or partial, meaning that in some embodiments, the device can eliminate the need for surgeons to push the device during surgery. In some embodiments, it can also reduce the stress required by surgeons during surgery. Anyone skilled in atherosclerosis resection knows that pushing can cause the device to buckle, break, or become stuck; and/or, patients may experience complications such as perforation of the treated vessel and perforation of the surrounding tissue.

The self-driving function of the atherosclerosis resection device taught herein can reduce the stress required by the surgeon performing the procedure. In some embodiments, the stress required by the surgeon performing the atherosclerosis resection can be reduced by any amount or range of 100%, 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5%, or in increments of 1%. In some embodiments, the pressure required by the surgeon performing atherosclerotic resection may be reduced by an amount ranging from about 25% to about 100%, from about 30% to about 100%, from about 35% to about 100%, from about 40% to about 100%, from about 45% to about 100%, from about 50% to about 100%, from about 60% to about 100%, from about 65% to about 100%, from about 70% to about 100%, from about 75% to about 100%, from about 80% to about 100%, from about 85% to about 100%, from about 90% to about 100%, from about 95% to about 100%, or any range thereof with an increment of 1%. Similarly, in some embodiments, the pressure required by the surgeon performing atherosclerosis resection can be reduced in the range of about 25% to about 95%, about 30% to about 90%, about 35% to about 85%, about 40% to about 80%, about 45% to about 75%, about 50% to about 70%, from about 60% to about 100%, from about 65% to about 100%, from about 70% to about 100%, from about 75% to about 100%, from about 80% to about 100%, from about 85% to about 100%, from about 90% to about 100%, from about 95% to about 100%, or any range in increments of 1%. Likewise, in some embodiments, the pressure required by the surgeon performing atherosclerosis resection can be reduced by a reduction of about 25% to about 50%, from about 50% to about 100%, or any range in increments of 1%. Similarly, in some embodiments, the pressure required by the surgeon to perform vascular resection can be reduced by at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or any range in increments of at least 1%.

In some embodiments, the surgeon may need to apply negative pressure, for example, sometimes holding or traction rather than pushing, to help control the cutting of the lesion. It should be understood that in some embodiments, the negative pressure can be -1%, 5%, 10%, 15%, 20%, or 25%, or any amount in increments of 1%. Such negative pressure can cause the cutting to slow down, stop, or move in the opposite direction to the self-driving direction of the cutter.

Those skilled in the art will appreciate that atherosclerosis resection devices will provide the versatility and operability required in the field for tortuous vessels. When plaque is located in a tortuous vessel or when the occlusion is off-center from the vascular channel, off-center cutting of the tissue helps to manipulate the cutting head to remove the plaque. Some atherosclerosis resection devices provide a mechanism in the device that pulls the distal end of the device laterally by pulling a "tendon," thereby creating an arc at the distal end of the device. The drawback of these devices is that they can cause the device to "snapback" or "whip" due to the unbalanced stress applied along the long axis of the atherosclerosis resection device. The device presented herein can perform off-center cutting without the "snapback" or "whip" phenomenon produced by these previously known mechanisms.

Figures 4A-4D illustrate a telescopic atherosclerosis resection device, which may further include a reversibly expandable lateral pushing member located distal to a flexible sheath. Figures 4A-4D show a telescopic atherosclerosis resection device, which, according to some embodiments, may further include a reversibly expandable lateral pushing member located distal to a flexible sheath, wherein expansion of the lateral pushing member results in a curve. As shown in Figure 4A, the telescopic atherosclerosis resection device 400 may further include a reversibly telescopic lateral pushing member 444 located distal to a flexible sheath 415, the lateral pushing member 444 creating a lateral protrusion relative to the central axis of the atherosclerosis resection device. The lateral pushing member 444 may have a proximal portion with a proximal end, a distal portion with a distal end, and a reversibly unfolded portion having a folded state (as shown in Figure 4A) and an unfolded state (as shown in Figures 4B and 4C). The protruding portion may rotate 1-360 degrees or any range thereof relative to the lesion site, for example, to reach any target area within the blood vessel.

The lateral actuation component can be made of any suitable material known to those skilled in the art. For example, the lateral actuation component can be made of flexible metal, biocompatible flexible metal, such as titanium alloy (e.g., nickel-titanium). In some embodiments, the lateral actuation component can be made of polymers such as PEEK, polyimide, or nylon. The length of the trusses or ribbon can be designed to provide any desired protrusion. For example, in some embodiments, the truss length can vary from 1 mm to 100 mm, in some embodiments from 10 mm to 30 mm, in some embodiments from 10 mm to 40 mm, in some embodiments from 10 mm to 50 mm, in some embodiments from 20 mm to 60 mm, and in some embodiments from 20 mm to 80 mm. In some embodiments, the length of the truss can be 1 mm, 2 mm, 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 100 mm, or any length in increments of 1 mm.

The reversibly deployable portion has trusses 488 that can be deployed and folded by applying an axial force to the lateral push member 444. In some embodiments, the trusses may be referred to as "ribbons". The proximal end of the lateral push member 444 is operatively connected to a flexible sheath 415, and the distal end of the lateral push member 444 is operatively connected to a cutter 430. The operative connection to the flexible sheath 415 and the operative connection to the cutter 430 can be configured to receive axial forces: (i) applied from the cutter 430 to the flexible sheath 415 along the axis of the flexible drive shaft 450; (ii) when an axial force is applied from the distal end to the proximal end, transmitted through the lateral push member 444 to expand the lateral push member 444, and when an axial force is applied from the proximal end to the distal end, the lateral push member 444 collapses, and the axial force is applied in the desired direction due to the reversible expansion and contraction of the flexible drive shaft 450 within the flexible sheath 415. The lateral pushing component 444 has an effective radius during collapse 445c and expansion 445e.

In some embodiments, the lateral pushing member 444 receives proximal-to-distal and distal-to-proximal forces at a proximal collar 455 on the proximal portion of the lateral pushing member 444 and a distal collar 466 on the distal portion of the lateral pushing member 444. Furthermore, the operable connection between the lateral pushing member 444 and the cutter 430 can be configured as a rotatable translational connection to facilitate rotation of the cutter 430 and the flexible drive shaft 450 without rotating or unduly twisting the distal end of the lateral pushing member 444 during operation of the atherosclerosis resection device 400.

Axial forces can be applied using any structure, such as a central component (e.g., a tendon), which applies force along the central axis of the drive shaft to avoid generating loads on the atherosclerosis resection device that would result in a rebound or whipping force released along the long axis of the device. In some embodiments, the structure providing the axial force can be a drive shaft already located at the center of the device, for example, a drive shaft concentric within a sheath. Thus, in some embodiments, the method of expanding the lateral thrust member includes applying a force from distal to proximal to the distal portion of the lateral thrust member along the central axis of the atherosclerosis resection device, the central axis of the drive shaft, or the central axis of the sheath.

The cutting blade 430 is pushed laterally towards the contact between the pushing component 444 and the blood vessel wall, deviating from the central axis of the blood vessel lumen in the opposite direction to the expansion direction of the truss 488. The turning radius of the cutting blade 430 is adjustable and controllable.

As shown in Figure 4B, the expansion of the truss 488 on the lateral pushing component 444 causes the cutter 430 of the atherosclerosis resection device 400 to deflect toward the vessel lumen wall 499, while the vessel lumen wall 499 is opposite to the vessel lumen wall 499 that receives the expansion force of the truss 488.

One or more retractable trusses can be used. In some embodiments, there is only one truss. In some embodiments, there are two trusses. In some embodiments, there are three trusses. In some embodiments, there are four trusses. In some embodiments, there are at least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 trusses. The trusses can be pre-formed to form a deflection curve or angle projecting outward from the central axis of the device. That is, in some embodiments, the trusses have shape memory, allowing the trusses to remain in a folded state and to be deployed by applying a force to the trusses, such as by pulling the central rib or drive shaft. In some embodiments, the trusses have shape memory, allowing the trusses to remain in an inflated state, maintaining the collapsed state by holding the trusses in a collapsed state and obtaining the inflated state by releasing the holding force and allowing the shape memory to return to the trusses. The trusses can be of any shape and, in some embodiments, can be a single truss or multiple trusses. In some embodiments, the trusses can be basket-shaped. In some embodiments, a balloon can be inflated to deflect the cutter instead of using a truss. For example, the truss can be an arc-shaped or inclined strip, which helps stabilize the flexible drive shaft.

The eccentric cutting of the device provided by this invention enables safe and clean cutting of tortuous and non-tortuous blood vessels, as well as eccentric lesions. The lateral pushing member 444 increases safety because without this lateral protrusion, the cutting assembly would deviate outward from the vessel's curvature, potentially cutting the vessel wall instead of the target plaque on the inner side of the vessel. The lateral pushing member 444 solves this problem by correcting the deviation by protruding the truss 488 outward from the vessel's curvature, thereby pushing the cutter laterally to the other side of the vessel, achieving a more controllable, efficient, and safer cut than conventional cutters. For example, when clearing eccentric lesions, the adjustable lateral pushing allows the cutting assembly to specifically target the side of the vessel with more stenotic material, achieving an eccentric cut.

In some embodiments, the effective cutting diameter can be approximately half the cutter diameter plus the lateral extent of the protrusion extending from the cutter's central axis. For example, if the cutter diameter is 2.2 mm and the protrusion extends 3.0 mm from the cutter axis, the effective cutting diameter is 4.1 mm. It can be seen that eccentric cutting results in a cutting area much larger than the cutter diameter.

In some embodiments, the degree of protrusion (from slight protrusion to maximum protrusion) is adjustable. For example, the distance between the two ends of the lateral push member or between the collars can be adjusted. That is, the distance between the two ends of the lateral push member or between the collars can be set as needed. In some embodiments, increasing the distance between the collars reduces truss expansion, thereby reducing cutter deviation. Similarly, decreasing the distance between the collars can increase truss expansion, thereby increasing cutter deflection. Those skilled in the art will understand that dials, knobs, buttons, or other actuators on the device can provide the device user with a measurement of the distance between the collars of the lateral push member 444. In some embodiments, an increase in the distance the drive shaft travels relative to the sheath increases the expansion of truss 488. Similarly, in some embodiments, a decrease in the distance the drive shaft travels relative to the sheath reduces the expansion of truss 488.

In some embodiments, the proximal portion or proximal end of the lateral pushing member 444 will have fixed contact with the distal portion or distal end of the sheath, while the distal portion or distal end of the drive shaft will have a rotatably translatably connected connection with the cutter; the proximal end of the cutter has a component including raceways and steps to allow the cutter to rotate even in the presence of the drive shaft. In some embodiments, the raceway may be referred to as a "bearing surface". For example, this component may be a fixed raceway or bearing; and similar components that allow the drive shaft to rotate freely at the distal portion or distal end of the lateral pushing member, while the lateral pushing member does not rotate.

Interestingly, it has been found that the relative bending stiffness of the drive shaft 450 compared to the truss 488 also helps control which part of the cutter 430 contacts and cuts the plaque on the vessel wall 499. For example, if the flexural stiffness of the drive shaft 450 is greater than that of the truss 488, then expansion of the truss 488 is unlikely to cause deformation 490 of the drive shaft 450, and contact between the cutter 430 and the vessel wall 499 will occur more frequently on one side of the cutter 430 body. However, if the flexural stiffness of the drive shaft 450 is less than that of the truss 488, then deformation of the drive shaft 450 is expected, and contact between the cutter 430 and the vessel wall 499 will occur more frequently at the distal end of the cutter 430.

In some embodiments, the flexural stiffness _FD of the distal portion of the flexible atherosclerosis resection device is less than or equal to the flexural stiffness _FLPM of the lateral pushing component. In some embodiments, the flexural stiffness _FD of the distal portion of the flexible atherosclerosis resection device is greater than or equal to the flexural stiffness _FLPM of the lateral pushing component. In some embodiments, the flexural stiffness _FD of the distal portion of the flexible atherosclerosis resection device is greater than the flexural stiffness _FLPM of the lateral pushing component.

Relative to F _LPM , _FD can be any amount or range of 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5%, or in increments of 1%. In some embodiments, the reduction in _FD relative to F _LPM can be from about 25% to about 80%, from about 30% to about 75%, from about 35% to about 75%, from about 40% to about 75%, from about 45% to about 75%, from about 50% to about 75%, from about 60% to about 75%, from about 65% to about 75%, from about 70% to about 75%, or in increments of 1%. Similarly, in some embodiments, the reduction of _FD relative to _FLPM can be from about 25% to about 50%, from about 30% to about 50%, from about 35% to about 50%, from about 40% to about 50%, from about 45% to about 50%, or any range where the increment is 1%. Likewise, in some embodiments, the reduction of _FD relative to _FLPM can be from a reduction of at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or any range or amount in increments of at least 1%.

Based on this information, those skilled in the art will understand that the amount of deformation can be selected by choosing the relative ratio of the flexural stiffness of the drive shaft 450 and the truss 488, which will allow the user of the atherosclerosis resection device additional control over the cutter. Therefore, in some embodiments, the atherosclerosis resection device 400 can be designed such that the flexural stiffness of the truss 488 is greater than the flexural stiffness of the drive shaft 450 to obtain the required amount of deflection of the drive shaft, thereby guiding the desired surface of the cutter 430 towards the vessel wall 499. In some embodiments, the flexural stiffness of the drive shaft may be equal to or greater than the flexural stiffness of the truss 488 to avoid drive shaft deflection. Those skilled in the art will understand that there are various methods to change the flexural stiffness of the drive shaft. For example, the stiffness or deflection of the drive shaft can be adjusted by changing the direction or combination of the filaments that make up the drive shaft. In some embodiments, to increase flexural stiffness, the filaments on the drive shaft can be bound together with a stiffer material, or the flexural stiffness can be increased (or decreased) by increasing (or decreasing) the filament size.

The lateral pushing component can be designed to expand into an arcuate protrusion. In some embodiments, the lateral pushing component can be folded to have an effective radius 445c less than or equal to the sheath radius. In some embodiments, the lateral pushing component can be folded to have an effective radius 445c less than or equal to the cutter radius. In some embodiments, the lateral pushing component can be folded to have an effective radius 445c less than or equal to the cutter clearing diameter radius to help facilitate movement of the device in the blood vessel.

Torsional stress on the lateral thrust member 444 is a design consideration. To reduce concerns about torsional stress on the lateral thrust member 444, the torsional stress on the distal end of the lateral thrust member can be reduced, the torsional stiffness of the lateral thrust member can be increased, or either of these design modifications can be implemented.

Figure 4C provides an alternative operable connection between the cutter and the lateral pusher according to some embodiments to address torsional stress issues. In some embodiments, the distal raceway is fixed, acting as a bearing raceway against the rotating cutter 430. However, in some embodiments, the distal raceway 477 rotates in contact with the distal collar 466 of both the rotating cutter 430 and the lateral pusher 444. Therefore, the distal raceway 477 can rotate freely, which in this case further reduces torsional stress on the lateral pusher 444. In some embodiments, the distal raceway 477 may be made of a low-friction material, such as Teflon.

Figure 4D illustrates how deformation 490 results in a curve at the distal portion of the atherosclerosis resection device. As discussed herein, the relative bending stiffness of the distal portion of the drive shaft 450 and the lateral pusher can lead to the formation of the curve because the applied force can cause lateral expansion of the truss 488, and, as described above, can also change the orientation of the cutter 430 in the lumen of the vessel (not shown). As shown in Figure 4B, deformation 490 can be restored to a straight position by extending and retracting the drive shaft. The straight position is shown in 4B. This realigns the cutter 430 in the lumen of the vessel (not shown) from the position of distal cutter-oriented cutting to the position of lateral cutter-oriented cutting.

It should be understood that the telescopic function, self-driving function, and lateral thrust function each have different technical advantages. Therefore, an atherosclerosis resection device can be simply a self-driving atherosclerosis resection device, meaning that the device does not require telescopic or lateral thrust. In these embodiments (whose components may be labeled as the same or similar to other embodiments taught herein), the device may have a distal portion with a distal end, a proximal portion with a proximal end, a long axis with a central axis, and a guidewire lumen extending through the device along the long axis. The device may include a flexible sheath having an outer diameter and a sheath cavity; a cutter having a proximal end, a distal end, and a body with multiple helical grooves. The distal end of the cutter may also have a point having multiple cutting lips, a cutter lumen, and a clearance diameter. These devices also include a drive assembly. The drive assembly may have a flexible drive shaft including an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity, the distal end of which is fixedly connected to the cutter, wherein the flexible drive shaft is rotatably and translationally oriented relative to the cavity of the flexible sheath. The drive assembly may also include a screw pump connected to the outer surface of the drive shaft and adjacent to the helical groove near the proximal end of the cutter. The screw pump may include a drive screw portion. In some embodiments, the drive screw portion may be the distal portion of the screw pump.

For example, to achieve self-drive, the drive screw portion may extend beyond the flexible sheath and be exposed to contact the vessel lumen during use of the atherosclerosis resection device. To effectively facilitate the drive device's passage through the vessel lumen, the drive screw should rotate in the same direction as the cutter. For example, if the cutter's groove rotates in a right-hand direction, the drive screw should also rotate in a right-hand direction. Similarly, if the cutter's groove rotates in a left-hand direction, the drive screw should rotate in a left-hand direction. Therefore, in some embodiments, the drive screw portion may be a right-handed screw when the cutter rotates in a right-hand direction; while in other embodiments, the drive screw portion may be a left-handed screw when the cutter rotates in a left-hand direction.

The relative dimensions of the inner cavity, cutter, and drive screw can be designed to optimize the self-driving function. In these embodiments, the clearing diameter of the cutter can be larger than the outer diameter of the flexible drive shaft; in some embodiments, the clearing diameter of the cutter can be larger than the outer diameter of the flexible sheath.

Of course, any self-driven device may also include a telescopic function, and its components may be labeled the same as or similar to other embodiments taught herein. For example, the flexible drive shaft of a self-driven atherosclerosis resection device may be longer than the flexible sheath to enable reversible extension and retraction of the drive assembly from the flexible sheath cavity at the distal end of the flexible sheath.

Furthermore, any self-driven device may also include a reversibly deployable lateral pusher, the components of which may be labeled the same as or similar to other embodiments taught herein. In some embodiments, the lateral pusher may have a proximal end, a distal end, a folded state, and an deployed state, with the proximal end operably connected to a flexible sheath and the distal end operably connected to a cutter. The operable connection to the flexible sheath and the operable connection to the cutter may be configured to receive the following axial forces: (i) an axial force applied from the cutter to the flexible sheath along the axis of the flexible drive shaft; and (ii) an axial force transmitted through the lateral pusher during the collapse and expansion of the flexible drive shaft reversibly extending and retracting from the flexible sheath. Furthermore, in some embodiments, the operable connection to the cutter may be configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pusher, particularly the distal portion of the lateral pusher, during operation of the atherosclerosis resection device.

Similarly, the atherosclerosis resection device can be simply a laterally driven atherosclerosis resection device that does not require self-drive, and whose components can be labeled as the same as or similar to other embodiments taught herein. However, it does require telescoping, at least to the extent necessary for the laterally driven components to expand and fold. In these embodiments, the device may have a distal end, a proximal end, a long axis, and a guidewire lumen extending through the device along the long axis. The device may include a flexible sheath having an outer diameter and a sheath cavity. The device may have a cutter having a proximal end, a distal end, and a body with multiple helical grooves, the distal end having multiple cutting lips, a cutter cavity, and a clearance diameter; and a drive assembly. The drive assembly may have a flexible drive shaft including an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity, the distal end of the flexible drive shaft being fixedly connected to the cutter, wherein the flexible drive shaft is rotatably translatable to the cavity of the flexible sheath. The drive assembly may also have a volumetric pump that initiates pumping near the helical grooves at the distal end of the drive shaft and the proximal end of the cutter. In addition, the lateral push atherosclerosis resection device can also have a reversibly expandable lateral push component installed at the distal end of the flexible sheath.

The relative dimensions of the lumen and the cutter can be designed to optimize the movement of the atherosclerosis resection device within the lumen. For example, the net diameter of the cutter can be larger than the outer diameter of the flexible drive shaft. In some embodiments, the net diameter of the cutter can be larger than the outer diameter of the flexible sheath. The sizes of the cutter cavity and the drive shaft cavity can be configured according to the passage of the required guidewire specification; therefore, the guidewire cavity may include both a cutter cavity and a drive shaft cavity.

In some embodiments, the lateral pushing member may include a proximal end having a proximal end, a distal end having a distal end, a folded state, and an unfolded state, the proximal end having an operative connection to a flexible sheath, and the distal end having an operative connection to a cutter. In some embodiments, the operative connection to the flexible sheath and the operative connection to the cutter may be configured to receive axial forces: (i) an axial force applied from the cutter to the flexible sheath along the axis of the flexible drive shaft; and (ii) an axial force transmitted through the lateral pushing member during the reversible collapse and expansion of the flexible drive shaft from the flexible sheath. Moreover, in some embodiments, the operative connection to the cutter may be configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pushing member during operation of the atherosclerosis resection device.

In some embodiments, the atherosclerosis resection device may also be telescopic, and its components may be labeled the same as or similar to those in other embodiments taught herein. That is, the flexible drive shaft of the laterally actuated atherosclerosis resection device may be longer than the length required for the extension and retraction of the lateral actuation component. The flexible drive shaft of the laterally actuated atherosclerosis resection device may be longer than the flexible sheath to enable reversible extension and retraction of the drive assembly from the lumen of the flexible sheath at its distal end.

Furthermore, in some embodiments, the lateral push atherosclerosis resection device may also be self-driven, and its components may be labeled the same as or similar to those in other embodiments taught herein. That is, the lateral push atherosclerosis resection device may include a drive screw connected to the distal outer surface of the drive shaft and adjacent to the screw pump distal to the screw pump. The drive screw may be part of the screw pump, extending beyond the flexible sheath and exposed to contact the vascular lumen during use. In some embodiments, the drive screw may be a right-handed screw when the cutter rotates in a right-hand direction; while in other embodiments, the drive screw may be a left-handed screw when the cutter rotates in a left-hand direction.

We have found that the ratio of (i) size and (ii) stiffness of the atherosclerosis resection device taught in this invention contributes to the device's performance and behavior, the ease of blade advance, the ability to rotate the atherosclerosis resection device, the ability to steer the device, the relative amount of plaque removed, etc. Table 2 illustrates the dimensions of the components of the atherosclerosis resection device, and Table 3 illustrates the size ratios of the components of the atherosclerosis resection device.

Table 2. Examples of component dimensions in millimeters.

Table 3. Examples of component size ratios

"Cutter outer diameter" refers to the maximum outer diameter of the cutter.

"Screw pump outer diameter" refers to the outer diameter of the drive shaft plus the two diameters of the screw pump wire surrounding the drive shaft.

"Drive shaft outer diameter" refers to the outer diameter of the drive shaft, excluding the two diameters of the screw pump wire.

"Sheath inner or outer diameter" refers to the inner or outer diameter of the hose or "sheath".

"Minimum front-end cutting outer diameter" refers to the outer diameter of the farthest end of the cutter with the cutting edge.

"Guidewire lumen inner diameter" refers to the inner diameter of the guidewire lumen.

"Outer diameter of the lateral pushing component" refers to the outer diameter of the lateral pushing component, which can be used in either the folded or unfolded state.

Studies have found that the relative dimensions of the device components have a significant impact on the movement of the device within the blood vessel lumen. In some embodiments, the cutter diameter should be at least 30% larger than the drive shaft diameter. The ratio of the cutter diameter to the drive shaft diameter may be 1.3 to 2.0 in some embodiments, 1.3 to 1.8 in some embodiments, 1.3 to 1.7 in some embodiments, 1.3 to 1.6 in some embodiments, 1.3 to 1.5 in some embodiments, 1.3 to 1.4 in some embodiments, or any range thereof. In some embodiments, the ratio of the cutter diameter to the drive shaft diameter may be 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, or 2.5, or any ratio with an increment of 0.05. However, in some embodiments, the cutter diameter is 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, or any percentage thereof with an increment of 0.5%, larger than the drive shaft diameter.

In some embodiments, the cutter diameter should be at least 20% larger than the sheath diameter. In some embodiments, the ratio of the cutter diameter to the sheath diameter can be 1.2 to 2.0, in some embodiments it can be 1.2 to 1.8, in some embodiments it can be 1.2 to 1.7, in some embodiments it can be 1.2 to 1.6, in some embodiments it can be 1.2 to 1.5, in some embodiments it can be 1.2 to 1.4, in some embodiments it can be 1.2 to 2.0, or any range thereof. In some embodiments, the ratio of the cutter diameter to the drive shaft diameter can be 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, or 2.5, or any ratio with an increment of 0.05. However, in some embodiments, the cutter diameter is 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, or any percentage thereof with an increment of 0.5%, larger than the sheath diameter.

Skilled technicians will understand that, in accordance with the teachings of this document, the drive shaft, sheath, and, in some embodiments, the lateral actuation component can be designed to possess the mechanical and physical properties required for atherosclerosis resection. In some embodiments, the mechanical and physical properties of the device provide sufficient strength to propel the cutter forward during the procedure, while also possessing sufficient flexibility to manipulate the cutter in tortuous blood vessels and align it with the guidewire.

Those skilled in the art will understand that the techniques provided herein may include the selection of flexural stiffness design for components to improve the performance, operability, and reliability of atherosclerosis resection devices. Flexural stiffness is a measure of the ability to deform, expressed in Newtons per millimeter. For example, flexural stiffness can be described as the ability of a component to bend without breaking or deforming when a bending force is applied. For example, in some embodiments, those skilled in the art may select the flexural stiffness of the drive shaft, sheath, or both to improve the operability of the atherosclerosis resection device, enabling it to follow a guidewire around tortuous blood vessels.

Those skilled in the art will also understand that the techniques provided herein may include the selection of torsional stiffness design for components to improve performance through torsional strength. Torsional stiffness refers to the ability to resist torsional loads, allowing a component to withstand rotational loads (torque) without unwinding, over-torsing, and/or deformation, and is measured in N*mm/rad. For example, in some embodiments, those skilled in the art may select the torsional stiffness of the drive shaft, the lateral pusher, or both to help ensure that the cutter can withstand the resistance of the plaque and cut without drive shaft failure, and that the lateral pusher does not rotate, or at least rotates only by a limited amount, to avoid lateral pusher device failure during atherosclerosis resection.

Those skilled in the art will also understand that the techniques presented herein may include the selection of axial tensile stiffness design for components to improve performance by enhancing the response of atherosclerosis resection devices to thrust and pull forces. Axial tensile stiffness refers to the tensile or contractile resistance along the length of the component under axial load, measured in N/mm. Key components for which axial tensile stiffness design should be selected include the drive shaft, sheath, and lateral thrust components.

Tables 4 and 5 illustrate the flexural stiffness, torsional stiffness, and axial stiffness of each component of the atherosclerosis resection device taught in this paper, as well as the relative stiffness ratio of each component.

Table 4. Examples of component stiffness in atherosclerosis resection devices.

Table 5. Examples of relative component stiffness ratios in atherosclerosis resection devices.

In some embodiments, the flexural stiffness of the sheath should be at least three times that of the drive shaft. In some embodiments, the ratio of the flexural stiffness of the drive shaft to the flexural stiffness of the sheath may be between 0.03 and 0.40, in some embodiments between 0.05 and 0.30, in some embodiments between 0.05 and 0.25, in some embodiments between 0.06 and 0.30, or any range therewith. In some embodiments, the ratio of the flexural stiffness of the drive shaft to the flexural stiffness of the sheath can be any ratio or range of 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.20, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.30, 0.31, 0.32, 0.33, 0.34, 0.35, 0.36, 0.37, 0.38, 0.39, 0.40, or an increment of 0.005, in some embodiments. However, in some embodiments, the flexural stiffness of the sheath is 3x, 4x, 5x, 6x, 7x, 8x, 9x, 10x or any range thereof greater than the flexural stiffness of the drive shaft.

Figures 5A-5C illustrate a compressible sleeve that can be used to increase the torsional stiffness of a lateral actuation component, provide protection for a positive displacement pump, and improve pumping efficiency, thereby improving the movement of cut particles. Figures 5A-5C illustrate a compressible sleeve that, according to certain embodiments, can be used to increase the torsional stiffness of a lateral actuation component, provide protection for a positive displacement pump, and improve pumping efficiency to improve the removal of cut particles from a container. Figures 5A and 5B show that the compressible sleeve 500 has a proximal portion 505, a distal portion 510, and a compressible portion 515 with a helical winding, the helical winding including gaps between each helix, spacing between each helix, and the width and thickness of the helical winding. In some embodiments, the helical winding of the compressible portion 515 is integrally formed with the proximal portion 505 and the distal portion 505.

Figure 5C illustrates deformation 590 of the distal portion of the atherosclerosis resection device. As discussed herein, the relative bending stiffness of the distal portion of the drive shaft 550 and the truss 588 in the lateral push member can lead to the formation of curve 590 when a force is applied to cause lateral expansion of the truss 588, and, as described above, can also alter the orientation of the cutter 630 in the lumen of the vessel (not shown). During the lateral expansion of the truss 588 and the deformation 590 of the drive shaft and compressible sleeve 500, the compressible sleeve 500 compresses the helical winding of the compressible portion 515. Therefore, according to some embodiments, the expansion of the truss 588 in the lateral push member can produce curve 590 in the distal portion of the atherosclerosis resection device.

Figure 5D illustrates the release of deformation 590 in the distal portion of the atherosclerosis resection device to straighten it. The drive shaft 550 extends and retracts from its sheath (not shown) to relieve the force between the drive shaft 550 and the truss 588, and to straighten both. This realigns the cutter 530 within the vessel lumen (not shown) from a position where the cutter 530 is distally facing the cutter to a position where the cutter 530 is laterally facing the cutter. As shown in Figure 5D, the compressible sleeve 500 relaxes the helical winding of the compressible portion 515 from deformation 590 caused by the lateral expansion of the truss 588 and restores it to its original straight position. Therefore, according to some embodiments, the expansion of the stringer 588 in the lateral pusher can release deformation 590 in the distal portion of the atherosclerosis resection device and restore it to a straight position.

A compressible sleeve 500 can be positioned outside the flexible drive shaft and between the proximal and distal ends of the lateral push member, allowing the flexible drive shaft 550 to rotate within the compressible sleeve. As shown, the lateral push member may have collars at each end, namely a proximal collar and a distal collar. The proximal portion 505 of the compressible sleeve 500 is operatively connected to the proximal collar of the lateral push member, and the distal portion 510 of the compressible sleeve 500 is operatively connected to the distal collar of the lateral push member. Due to the design of the compressible portion 515, the compressible sleeve 500 can bend and compress when the band of the lateral push member protrudes outward from a flat state, while providing additional torsional stiffness between the proximal and distal collars of the lateral push member to address torsional stresses on the lateral push member. In some embodiments, the distal and proximal collars of the lateral push member do not twist relative to each other, or at least any torsional movement is reduced. The compressible sleeve 500 also serves to cover the volumetric pump, referred to in some embodiments as an Archimedes screw. Therefore, the compressible sleeve 500 provides a safety shield when using an Archimedes screw to aspirate and cut plaque particles. Furthermore, it should be understood that covering the volumetric pump mechanism helps the pump retain particles within a fixed space, thereby aiding in particle removal. For example, in the case of a screw pump, the compressible sleeve, closely fitted to the screw mechanism, retains plaque particles within the lumen of the compressible sleeve 500, facilitating the screw mechanism 580 to remove particles from the treated blood vessel with greater efficiency. Additionally, when compressing the compressible sleeve 500, the expansion truss 588 of the lateral pusher requires the proximal and distal collars of the lateral pusher to come together, and compression occurs in the gap between the helices of the compressible sleeve 500 to allow for shortening.

The compressible sleeve 500 can be made of any suitable material known to those skilled in the art; for example, the choice of material determines the required bandwidth and thickness. In some embodiments, the compressible sleeve may be made of stainless steel, nickel-titanium alloy, other metal alloys, or polymers, PEEK, polycarbonate, nylon, or polyimide.

Table 6 lists dimensional examples of compressible sleeves 500, at least for lower limb blood vessels. Table 6. Dimensions of compressible sleeves designed for blood vessels.

Table 7. Flexural and torsional stiffness of drive shafts and compressible sleeves.

Tables 8 and 9 list the stiffness and ratio of the drive shaft and compressible sleeve:

Table 9. Stiffness ratio of pulse drive shaft and compressible sleeve

In some embodiments, the flexural stiffness of the drive shaft should be at least 50% greater than that of the drive compressible sleeve. The ratio of the flexural stiffness of the drive shaft to the flexural stiffness of the compressible sleeve may be 1.5 to 6.0 in some embodiments, 1.5 to 5.0 in some embodiments, 1.6 to 5.0 in some embodiments, 1.7 to 5.0 in some embodiments, or any range thereof. In some embodiments, the ratio of the flexural stiffness of the drive shaft to the flexural stiffness of the compressible sleeve is 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.2, 2.4, 2.6, 2.8, 3.0, 3.2, 3.4, 3.6, 3.8, 4.0, 4.2, 4.4, 4.6, 4.8, 5.0, 5.2, 5.4, 5.6, 5.8, 6.0, or any ratio or range thereof with an increment of 0.1. However, in some embodiments, the flexural stiffness of the drive shaft is 2x, 3x, 4x, 5x, 6x or any amount in increments of 0.1x or any range thereof greater than the flexural stiffness of the compressible sleeve.

Although the performance of the cutter can vary depending on factors including tissue type, any cutter known to those skilled in the art can be used in the atherosclerosis resection device described herein. Figures 6A and 6B illustrate other cutters that can be used according to certain embodiments. Both Figures 6A and 6B show a cutter 600 having a distal end 601, a proximal end 603, a lumen 605, and a groove 607. The cutter 600 in Figure 6A also has a burr portion 609, and the cutter 600 in Figure 6B has a hammer portion 611.

The cutter in Figure 6A has a swirl head portion 609, which, in some embodiments, can be fixed to the cutter. In some embodiments, the swirl head portion 609 can be integrally formed with the cutter. However, in some embodiments, the swirl head portion 609 can be operatively connected to the cutter using a friction joint, such that the swirl head can slide on the base of the cutter when it engages with the patch and meets the maximum torque limit.

The cutter in Figure 6B has a hammer portion 611, which in some embodiments may be fixed to a drive shaft. In some embodiments, the hammer portion 611 may be operably connected to the cutter using a friction joint, such that the hammer portion can slide on the drive shaft when it engages with the patch and meets a maximum torque limit. The hammer portion 611 has oscillating teeth 613 that can contact the blade portion 612 to generate an oscillating hammer effect on the patch for cutting.

The atherosclerosis resection system can also be assembled to include the atherosclerosis resection device taught herein. In some embodiments, any atherosclerosis resection device taught herein can be a system including an atherosclerosis resection device and a guidewire.

The atherosclerosis resection device is also applicable to several methods of performing atherosclerosis resection in a subject. In some embodiments, these methods may include creating an entry point in the lumen of a blood vessel in the subject; inserting the atherosclerosis resection device into the lumen; extending a flexible drive shaft; cutting plaque from the lumen using the cutter of the atherosclerosis resection device; draining the cut plaque from the lumen using a volumetric pump; and removing the atherosclerosis resection device from the lumen of the subject.

In some embodiments, the method may include creating an entry point in the lumen of a subject's blood vessel; inserting an atherosclerosis resection device into the lumen of the blood vessel; driving the atherosclerosis resection device through the lumen of the blood vessel with an exposed drive screw; cutting plaque from the lumen of the blood vessel with the cutter of the atherosclerosis resection device; draining the cut plaque from the lumen of the blood vessel with a volumetric pump; and removing the atherosclerosis resection device from the lumen of the subject's blood vessel.

Similarly, in some embodiments, the method may include creating an entry point in the lumen of a subject's blood vessel; inserting an atherosclerosis resection device into the lumen; laterally pushing the distal portion of the atherosclerosis resection device into the lumen, the pushing including expanding lateral pushing components; cutting plaque from within the lumen using the cutter of the atherosclerosis resection device; draining the cut plaque from within the lumen using a volumetric pump; and removing the atherosclerosis resection device from the subject's blood vessel.

Similarly, in some embodiments, the method may include a rotary grinding head abrasive patch, such as the rotary grinding head portion 609 shown in Figure 6A. The rotary grinding head may have ridges like the rotary grinding head portion 609, or it may have a grinding surface with the desired "grit".

Similarly, in some embodiments, these methods may include hammer-cutting blade configurations such as the cutting portion 612 of a cutter as shown in Figure 6B, which are configured to hammer-cut patches.

Those skilled in the art will understand that the above steps represent only an example of a series of steps that can be used in atherosclerotic resection. For example, in a simple embodiment, the method includes...

• Insert the atherosclerosis resection device taught in this article into the lumen of a subject's blood vessel. The atherosclerosis resection device has a distal end, a proximal end, a long axis, and a guidewire lumen passing through the device along the long axis.

A flexible sheath with an outer diameter and a sheath cavity; a cutter with a proximal end, a distal end, and a body with multiple helical grooves, the distal end having multiple cutting lips, a cutter cavity, and a clearing diameter; and

Driver components, including

A flexible drive shaft includes an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity. The distal end of the flexible drive shaft is fixedly connected to a cutter, and the cavity of the flexible drive shaft and the flexible sheath is rotatable and translatable.

The positive displacement pump begins pumping near the spiral grooves at the distal end of the drive shaft and the proximal end of the cutter;

• Advance the cutting blade to the target area within the subject's blood vessel lumen. The advancement process includes...

The distal end of the telescopic flexible drive shaft is moved away from the distal end of the flexible sheath to increase the flexibility of the atherosclerosis resection device within the vascular lumen.

The cutter is self-driven into the target area, and self-drive includes rotating the screw on the distal end of the flexible drive shaft;

Laterally push the distal end of the flexible sheath, the distal end of the flexible drive shaft, and the cutter against the vessel wall; or

Their combination;

• The plaque is cut off from the vessel wall; the cutting process includes rotating a cutting blade; and

• Using a volumetric pump to remove plaque from the blood vessel lumen; and

• Remove the atherosclerosis removal device from the subject.

It should be understood that the devices, systems, and methods provided herein can enhance functionality during atherosclerosis resection. In some embodiments, methods for steering the cutting head are provided, which may include reorienting the distal end of the flexible atherosclerosis resection device. In some embodiments, reorientation may include...

(i) Expanding the driving component, which includes pulling the centralized "component";

(ii) wherein the expanding lateral pushing component pushes the distal end of the flexible atherosclerosis resection device and bends/bends it.

For example, the centralized "component" can be a flexible drive shaft or a centralized tendon that is also freely translatable axially, i.e., translatable in the longitudinal direction, and in some embodiments can even form a guidewire lumen. The concentrated tension on or near the central axis of the atherosclerosis resection device, the central axis of the sheath, and the central axis of the drive shaft brings truly surprising and unexpected benefits. To reiterate this surprising result, the prior art provides a telescopic, self-driven, and laterally actuated atherosclerosis resection device, each device having a flexible sheath, a helical grooved cutter, and a drive assembly. The drive assembly may have a flexible drive shaft rotatably translatable with respect to the flexible sheath lumen, a volumetric pump that begins pumping at the distal end of the drive shaft, adjacent to the helical groove at the proximal end of the cutter, and the flexible drive shaft may be longer than the flexible sheath to allow reversible extension and retraction of the drive assembly from the flexible sheath lumen. The volumetric pump may be a screw pump, with its drive screw portion extending outside the flexible sheath and exposed within the vessel lumen for self-drive. Furthermore, the device may also have a reversibly expandable lateral actuation component at the distal end of the flexible sheath for lateral actuation.

Hybrid cutters are used to remove hard tissue, soft tissue, and combinations of hard and soft tissue.

The cutting efficiency of each atherosclerosis resection device taught in this paper can be improved through the design of the cutter. It should be understood that in some embodiments, the cutter may also be referred to as a "cutting head," "bit," "mill," or "end mill." Therefore, we provide a hybrid atherosclerosis cutter for cutting combinations of soft and hard plaques.

Figures 7A-7C illustrate the features of a cutting tool, including a primary and secondary cutting edge, grooves, helix angle, and guide wire cavity. Figures 7A-7C illustrate the features of a cutting tool according to some embodiments, including a primary and secondary cutting edge, grooves, helix angle, and guide wire cavity. As shown in Figure 7C, the cutting tool may include a proximal end, a distal end, and a longitudinal axis. Figure 7A is a perspective view of the proximal and distal ends of the cutting tool, Figure 7B is a view of the distal end of a three-groove cutting tool, and Figure 7C is a side view of a four-groove cutting tool. As shown in 7A, the cutting tool 700 may have a first primary cutting edge 705-1 and a second primary cutting edge 705-2, which extend radially and helically from the distal end to the proximal end. Similarly, there are also a first secondary cutting edge 710-1 and a second secondary cutting edge 710-2. The cutter 700 may have a first helical groove 730 and a second helical groove 731, each of the first helical groove 731 and the second helical groove 732 having a helix angle 770 relative to the longitudinal axis 701, and forming a helical channel with a distal inlet 735 and a proximal outlet 737, thereby opening the helical channel at both the distal and proximal ends to allow cut tissue to enter and flow out of the helical channel, which is the function of all cutters taught herein. Furthermore, the cutter 700 may also have a cavity 750 for the passage of a guide wire (not shown). As shown in FIG7B, in some embodiments, the cutter 700 may have a third primary cutting edge 705-3 and a third secondary cutting edge 710-3, as well as a third helical groove 733. As shown in FIG7C, in some embodiments, the cutter 700 may have a fourth primary cutting edge 705-4 and a fourth secondary cutting edge 710-4 (not shown), as well as a fourth helical groove 734 (indicated in FIG7C but not visible).

The main cutting edges can extend along the entire length of the cutter and, in some embodiments, can be divided into three distinct portions: a proximal portion, a middle portion, and a distal portion. The proximal portion of each main cutting edge can have a helical shape, for example, in some embodiments, it can follow a path of a constant diameter. The middle portion of each main cutting edge can also be helical or follow a constant diameter. Then, in some embodiments, the distal portion of each main cutting edge can taper gradually towards the distal end of the cutter.

In some embodiments, the secondary cutting edge may be shorter than the primary cutting edge. In some embodiments, the secondary cutting edge may be the same length as the primary cutting edge. In some embodiments, the length of the secondary cutting edge is less than half the length of the primary cutting edge. In some embodiments, the length of the secondary cutting edge is less than one-quarter the length of the primary cutting edge. In some embodiments, the length of the secondary cutting edge is approximately 5% to approximately 45% of the length of the primary cutting edge. In some embodiments, the secondary cutting edge can be formed by adding facets, which can be in the form of two adjacent planes, namely plane 1 and plane 2 facing the distal end of the cutter.

In some embodiments, the secondary cutting edge may be located between every two primary cutting edges, one of which is a first plane that coincides with the primary cutting edge, and the second plane is a second plane that coincides with the first plane.

In some embodiments, the secondary cutting edge, like the distal portion of the primary cutting edge, may gradually taper towards the distal end of the cutter. In some embodiments, both the secondary cutting edge and the primary cutting edge may decrease in size towards the distal end of the cutter.

In some embodiments, the distal portions of the secondary cutting edge and the distal portions of the primary cutting edge can act as anterior cutters, creating a channel for atherosclerotic resection in narrowed or completely blocked lesions. Furthermore, the anterior cutting achieved through the combination of the primary and secondary cutting edges can cut plaques into smaller particles than conventional, state-of-the-art atherosclerotic resection devices. In some embodiments, the helical profile of the primary cutting edge can continuously transfer tissue proximally during cutter operation, thereby continuously removing detached material.

Figures 8A-8D illustrate features of a cutter taught herein according to some embodiments, including cutting length, radius, and cutting diameter. As shown in Figures 8A-8D, the cutting length 820 of the cutter 800 is defined by the distance from the proximal end to the distal end along the longitudinal axis 801. The cutter 800 may be constructed to have a radius 840 at the distal end, with an inner inflection point 841 and an outer inflection point 843. The cutter may also have a cutting diameter 880, which is the maximum distance between the first primary cutting edge 805 and the second primary cutting edge 810, measured perpendicular to the normal to the longitudinal axis 801. Figure 8A shows that the radius 840 is the bulbous nose radius at the distal end of the cutter 800; in some embodiments, the radius may be half the cutting diameter. Figure 8B shows a cutter 800 with a radius 840, which is the angular radius at the distal end of the cutter, where the distal end of the cutter is approximately flat. Figure 8C shows a cutter 800 whose radius is generally the ball nose radius, but the farthest end of the cutter 800 is flat, and the radius is a mixture of the ball nose radius and the corner radius. Figure 8D shows a cutter 800 in which the cutting diameter 880 gradually decreases and tapers from the proximal end to the distal end, wherein the distal end can have a ball nose radius 840 (as shown), a corner nose radius (refer to Figure 8B), or a combination of the ball nose radius and the corner nose radius (refer to Figure 8C). The diameter of the distal end of this tapered cutter, measured at the outer inflection point 843, can be any percentage of 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or an increment of 1% of the cutting diameter 880 measured at the proximal end of the cutter.

Those skilled in the art will understand that, in many embodiments, the radius of the distal end of the cutter can have any desired shape. In some embodiments, the radius is the bulbous nose radius. In some embodiments, the radius is the corner radius. In some embodiments, the radius is a combination of the bulbous nose radius and the corner radius. In some embodiments, the radius is equal to half the cutter diameter.

Figures 9A-9C are perspective views, proximal views, and distal views of the primary and secondary cutting edges. 9A-9C illustrate perspective views, proximal views, and distal views of the primary and secondary cutting edges, as well as the primary and secondary cutting surfaces that shape the primary and secondary cutting edges and improve the cutter's ability to cut tissue, according to some embodiments. Dashed lines highlight at least the distal portions of the primary and secondary cutting edges. In Figures 9A and 9B, the cutter 900 shows a core 960 forming the central portion of the cutter 900 and containing a cutter cavity 950. In Figures 9A and 9B, the distal end of the core 960 is configured with a first plurality of secondary cutting surfaces 972, which form a first secondary cutting edge 910-1 at the distal end of a first helical groove 931 and after a first primary cutting edge 905-1; and a plurality of second cutting surfaces 974 forming a second secondary cutting edge 910-2 at the distal end of a second helical groove 932 and after a second primary cutting edge 905-2. Furthermore, the cutting tool may also have a third plurality of secondary cutting surfaces 976 at the distal end of the third helical groove (not shown), which form a third secondary cutting edge 910-3 after the third primary cutting edge 905-3. Those skilled in the art should understand that the creation of the secondary cutting edges 910-1, 910-2, and 910-3, and the introduction of the secondary cutting surfaces 972, 974, and 976, contribute to the cutting tool possessing the desired "hybrid" function, namely, effectively cutting both soft and hard tissues, i.e., plaques, within blood vessels.

Those skilled in the art should understand from the teachings provided herein that a "cut" is made in the "distal portion" of the cutter core, as defined herein as "core," and the distal portion is less than half the distal length of the cutter. In some embodiments, the distal portion is 49% of the distal length of the cutter. In some embodiments, the distal portion is 40% of the distal length of the cutter. In some embodiments, the distal portion is 30% of the cutter length. In some embodiments, the distal portion is 20% of the cutter length. In some embodiments, the distal portion is 15% of the cutter length. In some embodiments, the distal portion is 10% of the cutter length. In some embodiments, the distal portion is 25%, 24%, 23%, 22%, 21%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, or any amount of 0.1% of the cutter length. In some embodiments, the distal portion is greater than half the cutter length. In some embodiments, the distal portion is 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, or any amount of 0.1% of the cutter length.

This embodiment also includes a cutter with primary cutting surfaces to improve the cutting of tissue by the primary cutting edge. As shown in FIG9A, in some embodiments, the distal end of the core further includes a plurality of first primary cutting surfaces 971 located distal to the first primary cutting edge 905-1. FIG9A also illustrates that in some embodiments, the distal end of the core further includes a plurality of second primary cutting surfaces 973 distal to the second primary cutting edge 905-2. Furthermore, as shown in FIG9A, the cutter may have a third plurality of primary cutting surfaces 975 at the distal end of a third helical groove (not shown) to form a third primary cutting edge 905-3. In some embodiments, the plurality of first primary cutting surfaces 971 may be configured to extend the extent of the first primary cutting edge 905-1; the plurality of second primary cutting surfaces 973 may be configured to extend the distal extent of the second primary cutting edge 905-2; similarly, the plurality of third primary cutting surfaces 975 may be configured to extend the distal extent of the third primary cutting edge 905-3.

Those skilled in the art will understand that each type of cutter taught herein is designed to include grooves. In some embodiments, the cutter may have two grooves. In some embodiments, the cutter may have three grooves. In some embodiments, the cutter may have four grooves. In some embodiments, the cutter may have five grooves. In some embodiments, the cutter may have six grooves. Each groove is helical and may have a helix of any desired angle, such that combinations of grooves may have the same helix angle, or combinations of helix angles may be present on any single cutter.

As shown in Figure 9C, the flutes can have a flute depth 990, which can be determined by the distance between the core 960 surface at the inner point of the flute depth 990 and the main cutting edge 905-1 surface at the outer point of the flute depth 990. In some embodiments, the helix angle and/or flute depth can vary from the proximal end to the distal end of the flute. In some embodiments, the flute depth can range from 0.05 mm to 2.0 mm, from 0.1 mm to 1.5 mm, from 0.2 mm to 1.1 mm, from 0.4 mm to 1.1 mm, from 0.2 mm to 0.5 mm, from 0.3 mm to 0.4 mm, from 0.6 mm to 0.9 mm, or any range or number thereof in increments of 0.1 mm. In some embodiments, the groove depth can be 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, or any range or number in increments of 0.05 mm.

It should be understood that in some embodiments, the cutter has 2, 3, or 4 flutes. Those skilled in the art will understand that the cutter can have any desired number of flutes, at least 2, and at most a reasonable number, while maintaining the configuration of primary and secondary cutting edges. In some embodiments, the number of flutes matches the number of primary cutting edges, ranging from 2 to 8. In some embodiments, the number of flutes matches the number of primary cutting edges, and the number of flutes can be 2-4, 2-5, 2-6, 2-7, or 2-8. In some embodiments, the cutter can have 3 or 4 flutes. In some embodiments, the cutter has 3 flutes, 3 primary cutting edges, and 3 secondary cutting edges.

In some embodiments, each groove of the cutter may have the same or different angles compared to one or more other grooves on the cutter. For example, a technician may select a cutter with such a variable groove configuration to obtain a smoother cut. Therefore, in some embodiments, the flute angle may be constant or variable. For example, a technician may select a “variable helix,” or a variable flute angle between grooves, to suit materials that may be more resistant to cutting, and perhaps also improve cutting efficiency. A helix angle greater than 45° is considered a “high angle,” which removes material more effectively from the cut site and leaves a smoother cut surface while reducing tissue packaging and recutting of tissue; while a helix angle less than 40° is considered a “low angle,” which removes larger pieces of material in a given cutting time and leaves a rougher cut surface, while potentially resulting in tissue packaging and recutting of tissue in some applications. In some embodiments, the groove may have a high helix angle; in other embodiments, the groove may have a low helix angle. In some embodiments, the helix angle can be from 5° to 70°, or any angle therein. In some embodiments, the helix angle of the groove can be from 10° to 65°, or any angle therein. In some embodiments, the helix angle of the groove can be 15° to 60°, or any angle therein. In some embodiments, the helix angle of the groove can be 20° to 60°, or any angle therein. In some embodiments, the helix angle of the groove can be 25° to 60°, or any angle therein. In some embodiments, the helix angle of the groove can be 30° to 60°, or any angle therein. In some embodiments, the helix angle of the groove can be 35° to 40°, or any angle therein. In some embodiments, the helix angle of the groove can be 37° to 45°, or any angle therein. In some embodiments, the helix angle of the groove can be 30° to 45°, or any angle therein. In some embodiments, the helix angle of the groove can be from 45° to 60°, or any angle therein. Therefore, it can be understood that the helix angle of the groove can be approximately 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, or any angle in increments of 0.1°. Technicians will further understand that the cutter can have grooves with any combination of helix angles.

Figures 10A and 10B illustrate the mapping of primary and secondary cutting surfaces according to some embodiments and their relationship to primary and secondary cutting edges. Those skilled in the art will recognize from the illustrations and teachings that creating primary and secondary cutting surfaces at the distal end of the core helps improve cutting efficiency for both hard and soft plaques. Those skilled in the art will also understand that any number of cutting surfaces can be introduced; a cutting surface is a feature of the distal end or distal portion of the cutter, and in some embodiments may be planar, concave, or convex. As shown in Figure 10A, the cutter 1000 includes secondary cutting surfaces 1, 2, and 3, which are introduced at the distal end or distal portion of the core to produce secondary cutting edges 1010-1, 1010-2, and 1010-3. In some embodiments, the distal end of the core may be configured with a first plurality of secondary cutting surfaces 1, 2, 3, which form a first secondary cutting edge 1010-1 at the distal end of the first helical groove 1031; in some embodiments, the distal end of the core may be configured with a second plurality of secondary cutting surfaces 1', 2', 3', which form a second secondary cutting edge 1010-2 at the distal end of the second helical groove 1032; in some embodiments, the distal end of the core may be configured with a third plurality of secondary cutting surfaces 1”, 2”, 3”, which form a third secondary cutting edge 1010-3 at the distal end of the third helical groove 1033.

As further shown in Figure 10A, a plurality of first secondary cutting edges 1, 2 can be configured to extend the distal extent of the first secondary cutting edge 1010-1; in some embodiments, a plurality of second secondary cutting edges 1', 2' can be configured to extend the distal extent of the second secondary cutting edge 1010-2; similarly, in some embodiments, a plurality of third primary cutting surfaces 1”, 2” can be configured to extend the distal extent of the third secondary cutting edge 1010-3. The extended distal extent is represented by an elliptical dashed outline surrounding the distal secondary cutting edges 1010-1, 1010-2, 1010-3.

This embodiment also includes a cutter with primary cutting surfaces to improve the cutting of tissue with the primary cutting edge. As shown in FIG10A, the distal end of the core 1060 further includes a plurality of first primary cutting surfaces 2', 4 located at the distal end of the first primary cutting edge 1005-1. In some embodiments, the distal end of the core 1060 further includes a plurality of second primary cutting surfaces 2'', 4' located at the distal end of the second primary cutting edge 1005-2. In some embodiments, the distal end of the core 1060 further includes a plurality of third primary cutting surfaces 2', 4' located at the distal end of the third primary cutting edge 1005-3.

As further shown in Figure 10A, multiple first primary cutting surfaces 2', 4 can be configured to expand the distal extent of the first primary cutting edge 1005-1; in some embodiments, multiple second primary cutting surfaces 2”, 4’ can be configured to expand the distal extent of the second primary cutting edge 1005-2; similarly, in some embodiments, multiple third primary cutting surfaces 2, 4” can be configured to expand the distal extent of the third primary cutting edge 1005-3. The expanded distal extent is represented by the rectangular dashed outline around the distal secondary cutting edges 1010-1, 1010-2, 1010-3. Figure 10B shows the distal end of an actual cutter, illustrating these primary and secondary cutting edges on a prototype cutter that produces ideal results in cutting soft and hard tissues.

In some embodiments, the cut surfaces can be either primary cut surfaces used to form the main cutting edge or secondary cut surfaces used to form the secondary cutting edges 1010-1, 1010-2, and 1010-3. In Figures 10A and 10B, for example, cut surfaces 2, 2', and 2" are both primary and secondary cut surfaces. In fact, it can also be seen that cut surfaces 1, 1', and 1" primarily serve as secondary cut surfaces for the secondary cutting edges, but they are also used to shape small portions of the main cutting edges 1005-1, 1005-2, and 1005-3, and therefore they are also primary cut surfaces. Cut surfaces 3, 3', and 3" serve only as secondary cut surfaces, and cut surfaces 4, 4', and 4" serve only as primary cut surfaces, at least in the illustrated embodiments.

Figures 11A-11C show simplified views of the distal to proximal ends of 2-slot, 3-slot, and 4-slot cutters according to some embodiments. Figures 11A-11C illustrate simplified views of the distal ends of 2-slot, 3-slot, and 4-slot cutters according to some embodiments. These figures particularly show the distal edges of the facets used to shape at least the distal end of the secondary cutting edges. Figure 11A shows the distal end of a 2-slot cutter having two primary cutting edges 1105 and two secondary cutting edges 1110. In this embodiment, the distal end of the cutter is a quadrilateral polygon, which can be square or rectangular, and can have any desired cross-sectional area, with a minimum cross-sectional area greater than the cross-sectional area of the cutter cavity and less than the cross-sectional area determined by the cutter diameter. The sides of the quadrilateral polygon are the distal edges of the facets that form the secondary cutting edges. In Figure 11A, facets 1, 2, 1', and 2' at least define the distal portion of the secondary cutting edge 1110. Figure 11B shows the distal end of a 3-groove cutter with three main cutting edges 1105 and three secondary cutting edges 1110. In this embodiment, the distal end of the cutter is a hexagonal polygon, which can be hexagonal or triangular as shown in Figure 10B, and can have any desired cross-sectional area, with a minimum cross-sectional area greater than the cross-sectional area of the cutter cavity and less than the cross-sectional area determined by the cutter diameter. The sides of the hexagonal polygon are the distal edges of the facets that form the secondary cutting edges. In Figure 11B, facets 1, 2, 1', 2', 1”, and 2” at least define the distal portion of the secondary cutting edges 1110. Figure 11B also shows a side view of the distal end of the cutter, showing three optional shapes for the distal end: flat, convex, and concave. Those skilled in the art will understand that these are exemplary shapes, and any desired shape can be used to assist the main cutting edges, secondary cutting edges, and grooves in cutting and removing tissue. Figure 11C shows the distal end of a 4-flute cutter with four main cutting edges 1105 and four secondary cutting edges 1110. In this embodiment, the distal end of the cutter is an octagonal polygon, which can be either octagonal or rectangular, and can have any desired cross-sectional area, with a minimum cross-sectional area greater than the cross-sectional area of the cutter cavity but less than the cross-sectional area defined by the cutter diameter. The sides of the octagonal polygon are the distal edges of the facets that form the secondary cutting edge. In Figure 11C, facets 1, 2, 1', 2', 1”, 2”, 1”', and 2”' at least define the distal portion of the secondary cutting edge 1110. Figure 11C also shows a side view of the distal end of the cutter, illustrating three options for configuring tissue-destroying protrusions at the distal end: pointed, blunt, and concave. Those skilled in the art will understand that these are exemplary protrusions, and any desired protrusion can be used to achieve the function of destroying tissue to assist the primary cutting edge, secondary cutting edge, and groove in cutting and removing tissue.

It should be understood that any feature shown in Figures 11A-11C can be used in any cutting tool produced using the teachings provided herein, regardless of the combination and number of primary cutting edges, secondary cutting edges, flutes, cutting tool distal end shapes, and cross-sectional areas. However, this teaching does not imply that the example facets shown are always sufficient to obtain the desired shape of the cutting tool. It should also be understood that the facets shown for shaping at least the distal end of the secondary cutting edge may help shape at least the distal end of the primary cutting edge, but additional facets may be required, and often are necessary, to shape the desired distal end shape of at least the primary cutting edge.

Those skilled in the art will understand that the cutter can be configured with any number of primary and secondary cutting edges, and the number of primary and secondary cutting edges can be the same or different. In some embodiments, the cutter can have 2 primary cutting edges and 0 secondary cutting edges. In some embodiments, the cutter can have 2 primary cutting edges and 1 secondary cutting edge. In some embodiments, the cutter can have 2 primary cutting edges and 2 secondary cutting edges. In some embodiments, the cutter can have 2 primary cutting edges and 3 secondary cutting edges. In some embodiments, the cutter can have 3 primary cutting edges and 0 secondary cutting edges. In some embodiments, the cutter can have 3 primary cutting edges and 1 secondary cutting edge. In some embodiments, the cutter can have 3 primary cutting edges and 2 secondary cutting edges. In some embodiments, the cutter can have 3 primary cutting edges and 3 secondary cutting edges. In some embodiments, the cutter can have 3 primary cutting edges and 4 secondary cutting edges. In some embodiments, the cutter can have 4 primary cutting edges and 0 secondary cutting edges. In some embodiments, the cutter may have four main cutting edges and one secondary cutting edge. In some embodiments, the cutter may have four main cutting edges and two secondary cutting edges. In some embodiments, the cutter may have four main cutting edges and three secondary cutting edges. In some embodiments, the cutter may have four main cutting edges and four secondary cutting edges. In some embodiments, the cutter may have four main cutting edges and five secondary cutting edges.

In some embodiments, the cutter may have a third primary cutting edge extending helically from a distal end to a proximal end along the radius of the distal end of the cutter; and a third helical groove having a helical angle and forming a helical channel opening at both the distal and proximal ends. In some embodiments, the core may be further configured with a third plurality of secondary cutting surfaces, forming a third secondary cutting edge at the distal end of the third helical groove. Similarly, the core may further be configured with a third plurality of primary cutting surfaces at the distal end of the third primary cutting edge, the third plurality of primary cutting surfaces being configured to extend the distal extent of the third primary cutting edge.

In some embodiments, the cutter may have a third primary cutting edge extending helically from a distal end to a proximal end along the radius of the distal end of the cutter; a fourth primary cutting edge extending helically from a distal end to a proximal end along the radius; a third helical groove having a helix angle forming a helical channel opening at both the distal and proximal ends; and a fourth helical groove having a helix angle forming a helical channel opening at both the distal and proximal ends. In some embodiments, the core may be further configured such that: the distal end of the third helical groove forms a third plurality of secondary cutting surfaces of a third secondary cutting edge; and the distal end of the third helical groove forms a fourth plurality of secondary cutting surfaces of a fourth secondary cutting edge. Similarly, the core may be further configured such that: a third plurality of primary cutting edges are present at the distal end of the third primary cutting edge, the third plurality of primary cutting edges being configured to extend the distal extent of the third primary cutting edge; and a fourth plurality of primary cutting edges are present at the distal end of the fourth primary cutting edge, the fourth plurality of primary cutting edges being configured to extend the distal extent of the fourth primary cutting edge.

Those skilled in the art will understand that the primary and/or secondary cutting edges can be designed with a "relief angle" to reduce the resistance of the cutting edges to the tissue and improve the cutting efficiency of the cutter. However, the relief angle is not the same as the "cutting face" described in the art provided herein. While in some embodiments the cutting face may also provide a convex angle, the primary purpose of the cutting face is to remove core material so that a secondary cutting edge can be positioned at the distal end of the cutter, and in some embodiments, the distal extent of the primary cutting edge at the distal end of the cutter may also be extended.

Those skilled in the art will understand that any atherosclerosis resection device taught herein has several technical contributions of its own beyond the cutter configuration, and that any atherosclerosis resection device may include any cutter taught herein to further improve the performance of the atherosclerosis resection device. In some embodiments, the atherosclerosis resection device includes a cutter taught herein having a clearing diameter; a distal end, a proximal end, a long axis, and a guidewire lumen extending through the device along the long axis; a flexible sheath having an outer diameter and a sheath cavity; and a drive assembly having a flexible drive shaft including an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity, the distal end of the flexible drive shaft being fixedly connected to the cutter, wherein the flexible drive shaft is rotatably and translatably oriented relative to the cavity of the flexible sheath, and the drive assembly also having a volumetric pump that initiates pumping near a helical groove at the distal end of the drive shaft and the proximal end of the cutter. In these embodiments, the cutting diameter can be greater than the outer diameter of the flexible sheath; the flexible drive shaft can be longer than the flexible sheath so that the drive assembly can be reversibly extended and retracted from the flexible sheath cavity at the distal end of the flexible sheath; and the guide wire cavity can include a cutting cavity and a drive shaft cavity.

In some embodiments, the atherosclerosis resection device includes a cutter as taught herein, the cutter having a clearing diameter; a distal end, a proximal end, a long axis, and a guidewire lumen extending through the device along the long axis; a flexible sheath having an outer diameter and a sheath cavity; a drive assembly having a flexible drive shaft including an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity, the distal end of the flexible drive shaft being fixedly connected to the cutter, wherein the flexible drive shaft is rotatably and translatably oriented relative to the cavity of the flexible sheath, the drive assembly further having a screw pump connected to the outer surface of the drive shaft and adjacent to a helical groove at the proximal end of the cutter, the screw pump including a drive screw portion; wherein the drive screw portion extends beyond the flexible sheath and is exposed within the lumen of the vessel for contact with the lumen of the vessel when the atherosclerosis resection device is used within the lumen of the vessel; and, when the cutter rotates in a right-hand direction, the drive screw portion is a right-handed screw; or, when the cutter rotates in a left-hand direction, the drive screw portion is a left-handed screw. In these embodiments, the clearing diameter of the cutter can be larger than the outer diameter of the flexible drive shaft; and the guide wire cavity can include a cutter cavity and a drive shaft cavity.

In some embodiments, the atherosclerosis resection device includes a cutter as taught herein, the cutter having a cleared diameter; a distal end, a proximal end, a long axis, and a guidewire lumen extending through the device along the long axis; a flexible sheath having an outer diameter and a sheath lumen; and a drive assembly having a flexible drive shaft including an axis, a proximal end, a distal end, an outer surface, and a drive shaft lumen, the distal end of the flexible drive shaft being fixedly connected to the cutter, wherein the flexible drive shaft is rotatably and translatably oriented relative to the lumen of the flexible sheath. The drive assembly also includes a volumetric pump that pumps from the distal end of the drive shaft and is adjacent to a helical groove at the proximal end of the cutter. Furthermore, the atherosclerosis resection device may also have a reversibly expanding lateral pushing member at the distal end of the flexible sheath, the lateral pushing member having a proximal end, a distal end, a collapsed state, and an expanded state, the proximal end being operably connected to the flexible sheath, and the distal end being operably connected to the cutter. In these embodiments, the cleared diameter of the cutter may be larger than the outer diameter of the flexible sheath; the guidewire lumen may include a cutter lumen and a drive shaft lumen. Furthermore, the operable connection with the flexible sheath and the operable connection with the cutter can be configured to receive axial forces: (i) applied from the cutter along the axial direction of the flexible drive shaft to the flexible sheath; (ii) transmitted via a lateral pushing member during the reversible extension and retraction of the flexible drive shaft from the flexible sheath; and the operable connection with the cutter can be configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pushing member during operation of the atherosclerosis resection device.

Figure 12 illustrates a method for performing atherosclerosis resection according to some embodiments. Those skilled in the art will also understand that any method of performing atherosclerosis resection may include the use of any atherosclerosis resection device and any cutting tool taught herein. Regardless of the atherosclerosis resection device used, method 1200 may include creating an entry point 1205 in the lumen of a subject's blood vessel; inserting the atherosclerosis resection device 1210 into the lumen of the blood vessel; cutting the plaque 1215 from the lumen of the blood vessel using the cutting tool of the atherosclerosis resection device; draining the cut plaque 1255 from the lumen of the blood vessel using a volumetric pump; and removing the atherosclerosis resection device 1260 from the lumen of the subject's blood vessel. These methods may also include advancing the 1240 cutter head to contact the tissue for resection using the improved cutter control function of the atherosclerosis resection device provided herein, including extending the 1220 flexible drive shaft to contact the 1241 target tissue for resection, driving the 1225 cutter with an exposed drive screw to contact the 1244 target tissue for resection, pushing the 1230 cutter with a lateral pushing member to contact the 1247 target tissue for resection, or any combination thereof. Such combinations may include, for example, extension/drive 1242, lateral drive/push 1245, extension/lateral push 1243, and extension/drive/lateral push 1246. Thus, in addition to the optional step of selecting a cutter 1201 having a secondary cutting edge, a cutter 1201 for further distal extension of the main cutting edge may also be selected, with the selection limited to the various cutters taught herein. Figure 12 illustrates at least seven different methods of performing atherosclerosis resection using the atherosclerosis resection device taught herein.

Claims (44)

1. An atherosclerosis resection device, comprising: The distal end, proximal end, long axis, and guide wire lumen passing through the device along the long axis; A flexible sheath, having an outer diameter and a sheath cavity; A cutter having a proximal end, a distal end, and a body with multiple spiral grooves, wherein a point at the distal end has multiple cuts, a cutting cavity, and a clearing diameter; and Driver components, including A flexible drive shaft includes an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity. The distal end of the flexible drive shaft is fixedly connected to the cutter, and the cavity of the flexible drive shaft and the flexible sheath are rotatable and translatable. The positive displacement pump begins pumping near the spiral grooves at the distal end of the drive shaft and the proximal end of the cutter; in, The cutting diameter is larger than the outer diameter of the flexible drive shaft; The flexible drive shaft is longer than the flexible sheath so that the drive assembly can be reversibly extended and retracted from the cavity of the flexible sheath at the distal end of the flexible sheath. and, The guide wire cavity includes a cutter cavity and a drive shaft cavity. 2. The atherosclerosis resection device as claimed in claim 1, wherein the removal diameter of the cutting blade is larger than the outer diameter of the flexible sheath. 3. The atherosclerosis resection device of claim 1, wherein the volumetric pump is a screw pump connected to the outer surface of the drive shaft, and the distal end of the screw pump is adjacent to the helical groove of the proximal end of the cutter. 4. The atherosclerosis resection device as described in claim 3; wherein the screw pump Extending beyond the flexible sheath and exposed within the vascular lumen, so as to contact the vascular lumen when the atherosclerosis resection device is used within the vascular lumen; and When the cutter rotates in a right-hand direction, it is a right-hand screw; or When the cutter rotates to the left, it is a left-hand screw. 5. The atherosclerosis resection device as claimed in claim 1 further includes a reversibly retractable lateral pushing component located at the distal end of the flexible sheath. 6. The atherosclerosis resection device of claim 1 further includes a reversibly expandable lateral pushing component located at the distal end of the flexible sheath, the lateral pushing component having a proximal end, a distal end, a folded state, and an expanded state, the proximal end being operably connected to the flexible sheath, and the distal end being operably connected to the cutting blade; in, The operable connection with the flexible sheath and the operable connection with the cutter are respectively configured to receive axial forces: (i) applied from the cutter along the axial direction of the flexible drive shaft to the flexible sheath; (ii) axial forces of collapse and expansion transmitted through the lateral pushing member during the reversible extension and retraction of the flexible drive shaft from the flexible sheath; and The operable connection with the cutter is configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pusher during operation of the atherosclerosis resection device. 7. An atherosclerosis resection device, comprising: The distal end, proximal end, long axis, and guide wire lumen passing through the device along the long axis; A flexible sheath, having an outer diameter and a sheath cavity; A cutter having a proximal end, a distal end, and a body with multiple spiral grooves, wherein a point at the distal end has multiple cuts, a cutting cavity, and a clearing diameter; and Driver components, including A flexible drive shaft includes an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity. The distal end of the flexible drive shaft is fixedly connected to the cutter, and the cavity of the flexible drive shaft and the flexible sheath are rotatable and translatable. A screw pump, connected to the outer surface of the drive shaft and adjacent to the proximal helical groove of the cutter, the screw pump including a drive screw portion; wherein, the drive screw portion Extending beyond the flexible sheath, it is exposed to contact the vascular lumen when used within the vascular lumen by the atherosclerosis resection device; and When the cutter rotates in a right-hand direction, it is a right-hand screw; or When the cutter rotates in the left-hand direction, it is a left-hand screw; in, The cutting diameter is larger than the outer diameter of the flexible drive shaft; and The guide wire cavity includes a cutter cavity and a drive shaft cavity. 8. The atherosclerosis resection device of claim 7, wherein the removal diameter of the cutter is greater than the outer diameter of the flexible sheath. 9. The atherosclerosis resection device of claim 7, wherein the drive screw portion is the distal portion of the screw pump. 10. The atherosclerosis resection device of claim 7, wherein the flexible drive shaft is longer than the flexible sheath so as to reversibly extend and retract the drive assembly from the lumen of the flexible sheath at the distal end of the flexible sheath. 11. The atherosclerosis resection device of claim 7, further comprising a reversibly retractable lateral pushing member located at the distal end of the flexible sheath. 12. The atherosclerosis resection device of claim 11, wherein the lateral pushing member has a proximal end, a distal end, a folded state, and an expanded state, the proximal end being operably connected to the flexible sheath, and the distal end being operably connected to the cutting blade; in, The operable connection with the flexible sheath and the operable connection with the cutter are respectively configured to receive axial forces: (i) applied from the cutter along the axial direction of the flexible drive shaft to the flexible sheath; (ii) axial forces of collapse and expansion transmitted through the lateral pushing member during the reversible extension and retraction of the flexible drive shaft from the flexible sheath; and The operable connection with the cutter is configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pusher during operation of the atherosclerosis resection device. 13. An atherosclerosis resection device, comprising: The distal end, proximal end, long axis, and guide wire lumen passing through the device along the long axis; A flexible sheath, having an outer diameter and a sheath cavity; The cutter has a proximal end, a distal end, and a body with multiple spiral grooves, wherein a point at the distal end has multiple cuts, a cutter cavity, and a clearing diameter; Driver components, including A flexible drive shaft includes an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity. The distal end of the flexible drive shaft is fixedly connected to the cutter. The flexible drive shaft and the cavity of the flexible sheath are rotatable and translatable. The positive displacement pump begins pumping near the spiral grooves at the distal end of the drive shaft and the proximal end of the cutter; as well as, A reversibly retractable lateral pushing component at the distal end of the flexible sheath; in, The cutting diameter is larger than the outer diameter of the flexible drive shaft; and... The guide wire cavity includes a cutter cavity and a drive shaft cavity. 14. The atherosclerosis resection device of claim 13, wherein the removal diameter of the cutter is greater than the outer diameter of the flexible drive shaft. 15. The atherosclerosis resection device of claim 13, wherein the lateral pushing member has a proximal end, a distal end, a folded state, and an expanded state, the proximal end being operably connected to the flexible sheath, and the distal end being operably connected to the cutting blade; in, The operable connection with the flexible sheath and the operable connection with the cutter are respectively configured to receive axial forces: (i) applied from the cutter along the axial direction of the flexible drive shaft to the flexible sheath; (ii) axial forces of collapse and expansion transmitted through the lateral pushing member during the reversible extension and retraction of the flexible drive shaft from the flexible sheath; and The operable connection with the cutter is configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pusher during operation of the atherosclerosis resection device. 16. The atherosclerosis resection device of claim 13, wherein the flexible drive shaft is longer than the flexible sheath so as to reversibly extend and retract the drive assembly from the lumen of the flexible sheath at the distal end of the flexible sheath. 17. The atherosclerosis resection device of claim 13, further comprising a drive screw connected to the distal outer surface of the drive shaft and adjacent to the screw pump at the distal end of the screw pump; wherein the drive screw Extending beyond the flexible sheath and exposed within the vascular lumen, so as to contact the vascular lumen when the atherosclerosis resection device is used within the vascular lumen; When the cutter rotates in a right-hand direction, it is a right-hand screw; and When the cutter rotates in a right-hand direction, it is a right-hand screw; or When the cutter rotates in the left-hand direction, it is a left-hand screw. 18. A system comprising the atherosclerosis resection device and guidewire as claimed in claim 1. 19. A system comprising the atherosclerosis resection device and guidewire as claimed in claim 7. 20. A system comprising the atherosclerosis resection device and guidewire as claimed in claim 13. 21. A method for performing atherosclerosis resection on a subject using the atherosclerosis resection device as described in claim 1, the method comprising: Create an incision point within the subject's blood vessel lumen; The atherosclerosis resection device is inserted into the blood vessel lumen; The flexible drive shaft can be extended or retracted. The plaque is cut from inside the blood vessel lumen using the blade of the atherosclerosis resection device; The excised plaque is removed from the blood vessel lumen using the aforementioned volumetric pump; and The atherosclerosis resection device was removed from the subject's blood vessel lumen. 22. A method for performing atherosclerosis resection on a subject using the atherosclerosis resection device as described in claim 7, the method comprising: Create an incision point within the subject's blood vessel lumen; The atherosclerosis resection device is inserted into the blood vessel lumen; The atherosclerosis resection device is driven through the blood vessel lumen by an exposed drive screw; The plaque is cut from inside the blood vessel lumen using the blade of the atherosclerosis resection device; The excised plaque is removed from the blood vessel lumen using the aforementioned volumetric pump; and The atherosclerosis resection device was removed from the subject's blood vessel lumen. 23. A method for performing atherosclerosis resection on a subject using the atherosclerosis resection device as described in claim 13, the method comprising: Create an incision point within the subject's blood vessel lumen; The atherosclerosis resection device is inserted into the blood vessel lumen; The distal portion of the atherosclerosis resection device is laterally pushed within the blood vessel lumen, the pushing including expanding the lateral pushing component; The plaque is cut from inside the blood vessel lumen using the blade of the atherosclerosis resection device; The excised plaque is removed from the blood vessel lumen using the aforementioned volumetric pump; and The atherosclerosis resection device was removed from the subject's blood vessel lumen. 24. The atherosclerosis resection device of claim 1 further includes a compressible sleeve to increase the torsional stiffness of the lateral pushing member. 25. A hybrid atherosclerotic cutter for cutting soft and hard plaques, the cutter comprising: Proximal end, distal end, and longitudinal axis; The cutting length is determined by the distance along the longitudinal axis from the proximal end to the distal end; The radius at the far end, the radius having an inner inflection point and an outer inflection point; A first primary cutting edge and a second primary cutting edge, the first primary cutting edge and the second primary cutting edge extending from the distal end to the proximal end and spiraling along the radius; The first spiral groove and the second spiral groove each have a spiral angle and form a spiral channel that opens at the distal end and the proximal end. The cutting diameter is the maximum distance between the first main cutting edge and the second main cutting edge, and is measured perpendicular to the longitudinal axis. A core having a core diameter, a distal end, and a proximal end; wherein, the distal end of the core is configured with... Multiple first secondary cutting surfaces are formed at the distal end of the first spiral groove, forming a first secondary cutting edge; and Multiple second secondary cutting surfaces are formed at the distal end of the second spiral groove, forming a second secondary cutting edge; Among them, the cutter It has a cavity for the passage of a guidewire; and Effectively cuts soft and hard plaques in blood vessels. 26. The cutter of claim 25, wherein the radius is the bulb radius. 27. The cutter of claim 25, wherein the radius is a corner radius. 28. The cutter of claim 25, wherein the radius is equal to half the diameter of the cutter. 29. The cutter of claim 25, wherein the helix angle ranges from 30° to 45°. 30. The cutter of claim 25, wherein the distal end of the core further comprises Multiple first principal cutting surfaces located at the distal end of the first primary cutting edge; and Multiple second primary cutting surfaces located at the distal end of the second primary cutting edge; in, Multiple first primary cutting surfaces are configured to expand the extent of the first primary cutting edge; and Multiple second primary cutting surfaces are configured to extend the distal extent of the second primary cutting edge. 31. The cutter of claim 25, further comprising: The third primary cutting edge extends radially from the distal end to the proximal end in a spiral pattern; and A third helical groove with a helical angle forms a helical channel that opens at the distal and proximal ends. 32. The cutter of claim 25, further comprising: The third primary cutting edge extends radially from the distal end to the proximal end in a spiral pattern; and A third helical groove with a helical angle forms a helical channel that opens at the distal and proximal ends; The core is further configured with a third plurality of secondary cutting edges, which form a third secondary cutting edge at the distal end of the third helical groove. 33. The cutter of claim 25, further comprising: The third primary cutting edge extends radially from the distal end to the proximal end in a spiral pattern; and A third helical groove with a helical angle forms a helical channel that opens at the distal and proximal ends; The core is further configured with A third set of secondary cutting edges, which form a third secondary cutting edge at the distal end of the third helical groove; and A third plurality of primary cutting surfaces are configured at the distal end of the third primary cutting edge, the third plurality of primary cutting surfaces being configured to extend the distal range of the third primary cutting edge. 34. The cutter of claim 25, further comprising: The third primary cutting edge extends spirally from the distal end to the proximal end along the radius; The fourth primary cutting edge extends spirally from the distal end to the proximal end along the radius; A third helical groove with a helical angle forms a helical channel opening at both the distal and proximal ends; and A fourth helical groove with a helical angle forms a helical channel that opens at the distal and proximal ends. 35. The cutter of claim 25, further comprising: The third primary cutting edge extends spirally from the distal end to the proximal end along the radius; The fourth primary cutting edge extends spirally from the distal end to the proximal end along the radius; A third helical groove with a helical angle forms a helical channel opening at both the distal and proximal ends; and A fourth helical groove with a helical angle forms a helical channel that opens at both the distal and proximal ends; The core is further configured with A third plurality of secondary cutting surfaces are formed at the distal end of the third helical groove, forming a third secondary cutting edge; and A fourth plurality of secondary cutting surfaces are formed at the distal end of the third spiral groove, forming a fourth secondary cutting edge. 36. The cutter of claim 25, further comprising: The third primary cutting edge extends spirally from the distal end to the proximal end along the radius; The fourth primary cutting edge extends spirally from the distal end to the proximal end along the radius; A third helical groove with a helical angle forms a helical channel opening at both the distal and proximal ends; and A fourth helical groove with a helical angle forms a helical channel that opens at both the distal and proximal ends; The core is further configured with A third plurality of secondary cutting surfaces are formed at the distal end of the third spiral groove, forming a third secondary cutting edge; A third plurality of principal cutting surfaces at the distal end of the third primary cutting edge, the third plurality of principal cutting surfaces being configured to extend the distal extent of the third primary cutting edge; A fourth plurality of secondary cutting surfaces are formed at the distal end of the third spiral groove, forming a fourth secondary cutting edge; A fourth plurality of primary cutting surfaces are located at the distal end of the fourth primary cutting edge, the fourth plurality of primary cutting surfaces being configured to extend the distal extent of the fourth primary cutting edge. 37. An atherosclerosis resection device, comprising: The cutter of claim 25, wherein the cutter has a clearing diameter; The distal end, proximal end, long axis, and guide wire lumen passing through the device along the long axis; A flexible sheath, having an outer diameter and a sheath cavity; and Driver components, including A flexible drive shaft includes an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity. The distal end of the flexible drive shaft is fixedly connected to the cutter. The flexible drive shaft and the cavity of the flexible sheath are rotatable and translatable. The positive displacement pump begins pumping near the spiral grooves at the distal end of the drive shaft and the proximal end of the cutter; in, The cutting diameter is larger than the outer diameter of the flexible drive shaft; The flexible drive shaft is longer than the flexible sheath so that the drive assembly can be reversibly extended and retracted from the cavity of the flexible sheath at the distal end of the flexible sheath. and, The guide wire cavity includes a cutter cavity and a drive shaft cavity. 38. An atherosclerosis resection device, comprising: The cutter of claim 25, wherein the cutter has a clearing diameter; The distal end, proximal end, long axis, and guide wire lumen passing through the device along the long axis; A flexible sheath, having an outer diameter and a sheath cavity; as well as, Driver components, including A flexible drive shaft includes an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity. The distal end of the flexible drive shaft is fixedly connected to the cutter, and the cavity of the flexible drive shaft and the flexible sheath are rotatable and translatable. A screw pump, connected to the outer surface of the drive shaft and adjacent to the proximal helical groove of the cutter, the screw pump including a drive screw portion; wherein, the drive screw portion Extending beyond the flexible sheath, it is exposed to contact the vascular lumen when used within the vascular lumen by the atherosclerosis resection device; and When the cutter rotates in a right-hand direction, it is a right-hand screw; or When the cutter rotates in the left-hand direction, it is a left-hand screw; in, The cutting diameter is larger than the outer diameter of the flexible drive shaft; and The guide wire cavity includes a cutter cavity and a drive shaft cavity. 39. An arteriosclerosis resection device, comprising: The cutter as claimed in claim 25 has a clearing diameter; The distal end, proximal end, long axis, and guide wire lumen passing through the device along the long axis; A flexible sheath, having an outer diameter and a sheath cavity; Driver components, including A flexible drive shaft includes an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity. The distal end of the flexible drive shaft is fixedly connected to the cutter. The flexible drive shaft and the cavity of the flexible sheath are rotatable and translatable. A volumetric pump begins pumping near the helical groove at the distal end of the drive shaft and the proximal end of the cutter; as well as, A reversible, retractable lateral pushing member located at the distal end of the flexible sheath, the lateral pushing member having a proximal end, a distal end, a folded state, and an expanded state, the proximal end being operably connected to the flexible sheath, and the distal end being operably connected to the cutter; in, The cutting diameter is larger than the outer diameter of the flexible drive shaft; The guide wire cavity includes a cutter cavity and a drive shaft cavity; The operable connection with the flexible sheath and the operable connection with the cutter are respectively configured to receive axial forces: (i) applied from the cutter along the axial direction of the flexible drive shaft to the flexible sheath; and (ii) axial forces of collapse and expansion transmitted through the lateral pushing member during the reversible extension and retraction of the flexible drive shaft from the flexible sheath. The operable connection with the cutter is configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pusher during operation of the atherosclerosis resection device. 40. An atherosclerosis resection device, comprising: The cutter as claimed in claim 33, wherein the cutter has a clearing diameter; The distal end, proximal end, long axis, and guide wire lumen passing through the device along the long axis; A flexible sheath, having an outer diameter and a sheath cavity; and Driver components, including A flexible drive shaft includes an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity. The distal end of the flexible drive shaft is fixedly connected to the cutter. The flexible drive shaft and the cavity of the flexible sheath are rotatable and translatable. A volumetric pump begins pumping near the helical groove at the distal end of the drive shaft and the proximal end of the cutter; in, The cutting diameter is larger than the outer diameter of the flexible drive shaft; The flexible drive shaft is longer than the flexible sheath so that the drive assembly can be reversibly extended and retracted from the cavity of the flexible sheath at the distal end of the flexible sheath. and, The guide wire cavity includes a cutter cavity and a drive shaft cavity. 41. An arteriosclerosis resection device, comprising: The cutter as claimed in claim 33, wherein the cutter has a clearing diameter; The distal end, proximal end, long axis, and guide wire lumen passing through the device along the long axis; A flexible sheath, having an outer diameter and a sheath cavity; as well as, Driver components, including A flexible drive shaft includes an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity. The distal end of the flexible drive shaft is fixedly connected to the cutter, and the cavity of the flexible drive shaft and the flexible sheath are rotatable and translatable. A screw pump, connected to the outer surface of the drive shaft and adjacent to the proximal helical groove of the cutter, the screw pump including a drive screw portion; wherein, the drive screw portion Extending beyond the flexible sheath, it is exposed to contact the vascular lumen when used within the vascular lumen by the atherosclerosis resection device; and When the cutter rotates in a right-hand direction, it is a right-hand screw; or When the cutter rotates in the left-hand direction, it is a left-hand screw; in, The cutting diameter is larger than the outer diameter of the flexible drive shaft; and The guide wire cavity includes a cutter cavity and a drive shaft cavity. 42. An arteriosclerosis resection device, comprising: The cutter as claimed in claim 33 has a clearing diameter; The distal end, proximal end, long axis, and guide wire lumen passing through the device along the long axis; A flexible sheath, having an outer diameter and a sheath cavity; Driver components, including A flexible drive shaft includes an axis, a proximal end, a distal end, an outer surface, and a drive shaft cavity. The distal end of the flexible drive shaft is fixedly connected to the cutter. The flexible drive shaft and the cavity of the flexible sheath are rotatable and translatable. A volumetric pump begins pumping near the helical groove at the distal end of the drive shaft and the proximal end of the cutter; as well as, A reversible, retractable lateral pushing member located at the distal end of the flexible sheath, the lateral pushing member having a proximal end, a distal end, a folded state, and an expanded state, the proximal end being operably connected to the flexible sheath, and the distal end being operably connected to the cutter; in, The cutting diameter is larger than the outer diameter of the flexible drive shaft; The guide wire cavity includes a cutter cavity and a drive shaft cavity; The operable connection with the flexible sheath and the operable connection with the cutter are respectively configured to receive axial forces: (i) applied from the cutter along the axial direction of the flexible drive shaft to the flexible sheath; and (ii) axial forces of collapse and expansion transmitted through the lateral pushing member during the reversible extension and retraction of the flexible drive shaft from the flexible sheath. The operable connection with the cutter is configured as a rotatable translational connection to facilitate rotation of the cutter and the flexible drive shaft without rotating the lateral pusher during operation of the atherosclerosis resection device. 43. A method for performing atherosclerosis resection on a subject using the atherosclerosis resection device as described in claim 39, the method comprising: Create an incision point within the subject's blood vessel lumen; The atherosclerosis resection device is inserted into the blood vessel lumen; Telescopic flexible drive shaft; The plaque is cut from inside the blood vessel lumen using the blade of the atherosclerosis resection device; The excised plaque is removed from the blood vessel lumen using the aforementioned volumetric pump; and The atherosclerosis resection device was removed from the subject's blood vessel lumen. 44. A method for performing atherosclerosis resection on a subject using the atherosclerosis resection device as described in claim 42, the method comprising: Create an incision point within the subject's blood vessel lumen; The atherosclerosis resection device is inserted into the blood vessel lumen; The atherosclerosis resection device is driven through the blood vessel lumen by an exposed drive screw; The plaque is cut from inside the blood vessel lumen using the blade of the atherosclerosis resection device; The excised plaque is removed from the blood vessel lumen using the aforementioned volumetric pump; and The atherosclerosis resection device was removed from the subject's blood vessel lumen.