Atherectomy catheter with a formable distal tip

Abstract

An atherectomy catheter for use in a blood vessel includes a catheter and a rotatable cutter. The rotatable cutter can translate within the catheter to extend the cutter through a window of the catheter or retract it into the catheter. The catheter can have a fixed curve and / or a formable portion configured to facilitate positioning and movement of the cutter. In some cases, the cutter is configured to tilt and / or move radially relative to the catheter during translation.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 024,306, filed on May 13, 2020, entitled “ATHERECTOMY CATHETER WITH SHAPEABLE DISTAL TIP,” and U.S. Provisional Patent Application No. 62 / 923,368, filed on October 18, 2019, entitled “ATHERECTOMY CATHETER WITH SHAPEABLE DISTAL TIP,” each of which is incorporated by reference in its entirety.

[0003] This application may also be related to International Application No. PCT / US2017 / 040431, filed on June 30, 2017, entitled “ATHERECTOMY CATHETER WITH SHAPEABLE DISTAL TIP,” which claims priority to U.S. Provisional Patent Application No. 62 / 357,173, filed on June 30, 2016, entitled “ATHERECTOMY CATHETER WITH SHAPEABLE DISTAL TIP,” each of which is incorporated by reference in its entirety.

[0004] This application may also be related to International Application No. PCT / US2019 / 028415, entitled “OCCLUSION-CROSSING DEVICES,” filed on April 19, 2019, which claims priority to U.S. Provisional Patent Application No. 62,768,769, entitled “OCCLUSION-CROSSING DEVICES,” filed on November 16, 2018, and U.S. Provisional Patent Application No. 62 / 660,185, entitled “OCCLUSION-CROSSING DEVICES,” filed on April 19, 2018, each of which is incorporated by reference in its entirety.

[0005] Incorporated by Reference

[0006] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0007] Devices for treating obstructed body lumens, such as devices for removing obstructive material from blood vessels, are described herein. In particular, atherectomy catheters adapted for easily manipulating plaque accumulations within tissues and blood vessels for debulking procedures are described herein. Background Art

[0008] Atherosclerosis is a disease caused by the buildup of plaque called atheroma within a person's arteries. Atherosclerosis develops as part of the natural aging process, but it can also occur due to a person's diet, high blood pressure, damage to blood vessels, genetics, and other factors. Atherosclerosis can affect any artery in the body, including those in the heart, brain, arms, legs, pelvis, and kidneys. The nature of atherosclerotic deposits can also vary. Some deposits are relatively soft, other types can be fibrous, some can be calcified, or a combination of all three. Depending on where the plaque accumulates, different diseases can result. For example, coronary artery disease (CAD) occurs when plaque accumulates in the coronary arteries that supply oxygenated blood to the heart. If plaque buildup blocks the carotid arteries, the arteries on either side of the neck that supply oxygen to the brain, a stroke can result.

[0009] Atherosclerosis can be treated in a variety of ways, including medication, bypass surgery, and catheter-based approaches. Atherectomy involves the excision or removal of material blocking a blood vessel. Many atherectomy catheters typically have a substantially straight central axis. However, atherectomy catheters with a straight profile can be difficult to maneuver close enough to the inner surface of the artery wall to remove all plaque buildup. Furthermore, plaque removal with such straight-profile catheters can be complicated when plaque buildup accumulates in curved and more tortuous sections of an artery.

[0010] The atherectomy catheter described herein addresses some of these challenges. Summary of the Invention

[0011] This article describes an atherectomy catheter for use in a blood vessel. The catheter can include a rotatable cutter positioned within the catheter. The shape of the catheter can be configured to facilitate optimal positioning of the cutter during a cutting procedure, for example. In some cases, the cutter can extend through a window in the catheter as it translates within the catheter. In some cases, the cutter can be retracted into the catheter.

[0012] In one embodiment, an atherectomy catheter for use in a blood vessel includes an elongated catheter body and an annular cutter. The elongated catheter body includes a fixed jog segment having a predetermined curvature and a flexible segment having greater flexibility than the remainder of the elongated catheter body. The fixed jog segment and the flexible segment are formed by a frame having a plurality of circumferential slits therein.

[0013] This embodiment and other embodiments may include one or more of the following features. The frame in the fixed convex section may further include a longitudinal ridge extending therethrough, the longitudinal ridge having no slits. The atherectomy catheter may further include a cutting window, with the annular cutter extending through the cutting window. The cutting window may be disposed distally of the fixed convex section and the flexible section to advance the cutter into the blood vessel. The atherectomy catheter may further include at least one laminate layer disposed above or below the frame of the fixed convex section. The laminate layer may be made of a polymer. The frame may be made of metal. The plurality of circumferential slits may be arranged in a repeating pattern. The fixed convex section may form an angle of 130° to 160° in the elongated catheter body. The frame may further include an annular ridge without slits extending between the fixed convex section and the flexible section. The flexible section may be configured to passively bend to an angle of 130° to 160°.

[0014] Generally, in one embodiment, an atherectomy catheter for use in a blood vessel includes an elongated catheter body, an annular cutter, and a curved portion disposed within the elongated catheter body. The curved portion can have any of a variety of shapes, such as an S-shape. The curved portion includes a frame having a plurality of annular ridges connected by longitudinal proximal ridges and longitudinal distal ridges. The longitudinal proximal ridges are disposed approximately 180 degrees away from the longitudinal distal ridges.

[0015] This embodiment and other embodiments may include one or more of the following features. The plurality of annular ridges may include a first annular ridge, a second annular ridge, and a third annular ridge. A longitudinal proximal ridge may connect the first annular ridge and the second annular ridge, and a longitudinal distal ridge may connect the second annular ridge and the third annular ridge. The atherectomy catheter may further include a cutting window through which the annular cutter extends. The cutting window may be disposed distally of the curved portion and on the outer circumference of the S-shaped bend to facilitate advancement of the cutter into the blood vessel. The S-shaped bend may be configured to be actuated by pulling or pushing on the shaft of the atherectomy catheter. The atherectomy catheter may further include at least one laminate layer disposed above or below the frame. The laminate layer may be made of a polymer. The frame may be made of metal. The distal longitudinal ridge may be disposed proximate to the exposed portion of the cutter. The distal longitudinal ridge may be located on the same side of the elongated catheter body as the exposed portion of the cutter. The longitudinal proximal ridge may form a first angle, and the longitudinal distal ridge may form a second angle. The first angle and the second angle may extend in opposite directions, and the first angle may be between 140 and 160 degrees, and the second angle may be between 140 and 160 degrees. A distal-most ridge of the plurality of ridges may include a beveled distal edge. The atherectomy catheter may further include a nose cone configured to pivot away from the elongated body to expose the cutter. The bevel may be configured to provide pivoting space for the nose cone.

[0016] Generally, in one embodiment, an atherectomy catheter for use in a blood vessel includes an elongated catheter body, an annular cutter, and an S-shaped curved portion disposed within the elongated catheter body. The curved portion includes a frame having a proximal segment and a distal segment. The proximal segment has a plurality of circumferential proximal slits and a longitudinal proximal ridge without slits, and the distal segment has a plurality of circumferential distal slits and a longitudinal distal ridge without slits. The longitudinal proximal ridge is disposed approximately 180 degrees away from the longitudinal distal ridge.

[0017] This embodiment and other embodiments may include one or more of the following features. The atherectomy catheter may further include a cutting window through which the annular cutter extends. The cutting window may be disposed distally of the distal segment and on the outer circumference of the S-shaped bend to facilitate advancing the cutter into the blood vessel. The S-shaped bend may be configured to be actuated by pulling or pushing on the shaft of the atherectomy catheter. The atherectomy catheter may further include at least one laminate layer disposed above or below the frame. The laminate layer may be made of a polymer. The frame may be made of metal. The plurality of circumferential proximal slits may be arranged in a first repeating pattern, and the plurality of circumferential distal slits may be arranged in a second repeating pattern. The first repeating pattern and the second repeating pattern may be circumferentially offset from one another. A distal longitudinal ridge may be disposed proximate to the exposed portion of the cutter. The distal longitudinal ridge may be located on the same side of the elongated catheter body as the exposed portion of the cutter. The proximal segment may form a first angle, and the distal segment may form a second angle. The first angle and the second angle may extend in opposite directions, and the first angle may be between 140 and 160 degrees, and the second angle may be between 140 and 160 degrees. The frame may further include an annular ridge extending between the proximal and distal segments without a slit.

[0018] Generally, in one embodiment, an atherectomy catheter for use in a blood vessel includes an elongated catheter body, an annular cutter, and an S-shaped curved portion disposed within the elongated catheter body. The curved portion includes a frame having a proximal segment and a distal segment. The proximal segment has a plurality of circumferential proximal slits and a longitudinal proximal ridge without slits, and the distal segment has a plurality of circumferential distal slits and a longitudinal distal ridge without slits. The longitudinal proximal ridge is disposed approximately 180 degrees away from the longitudinal distal ridge, and the circumferential slits are tongue-and-groove in nature.

[0019] In some examples, an atherectomy device includes a catheter comprising a distal nose cone fixedly coupled to a proximal flexible segment, and a cutter window located between the distal nose cone and the proximal flexible segment, wherein the curvature range of the proximal flexible segment is adjustable; and a cutter coupled to a rotatable drive shaft within the catheter, wherein proximal movement of the cutter and the rotatable drive shaft causes the cutter to tilt in a first direction and extend through the cutter window, and wherein distal movement of the cutter and the rotatable drive shaft causes the cutter to tilt in a second direction opposite the first direction and retract into the catheter. The curvature range of the proximal flexible segment can be adjusted based on the amount of force applied to the cutter and the rotatable drive shaft in the proximal direction. Initial proximal movement of the cutter and the rotatable drive shaft can cause the cutter to tilt in the first direction and extend through the cutter window, wherein further proximal movement of the cutter and the rotatable drive shaft can cause the flexible segment to bend. Similarly, distal movement of the cutter and the rotatable drive shaft can cause the flexible segment to straighten from a bent state. The proximal flexible segment can be configured to bend into an S-shape. The proximal flexible segment can be configured to bend incrementally via proximal movement of the cutter and the rotatable drive shaft based on the amount of compression on the proximal flexible segment. The cutter can include a boss configured to slide along an edge of the inner surface of the catheter to radially move the cutter and extend the cutter through the cutting window. The edge can be tilted relative to an axis perpendicular to the longitudinal axis of the distal nose cone. The edge can be configured to tilt the cutter relative to the nose cone when the boss of the cutter slides along the edge. The edge can be located on a hub of the catheter. The cutter window can be located on a side of the catheter.

[0020] In some examples, an atherectomy device includes a catheter including a nose cone fixedly coupled to an elongated body at a fixed bend of the catheter, wherein the catheter includes a cutter window located on a convex side of the fixed bend; and a cutter coupled to a rotatable drive shaft within the catheter, wherein proximal movement of the cutter and the rotatable drive shaft causes the cutter to tilt in a first direction and extend through the cutter window, and wherein distal movement of the cutter and the rotatable drive shaft causes the cutter to tilt in a second direction opposite the first direction and retract into the catheter. The cutting window may be located distally along the catheter relative to the fixed bend. The cutter may be configured to move radially when extending through the cutting window. When the cutter extends through the window, at least a portion of the cutting edge of the cutter may correspond to a most protruding point along the convex side of the fixed bend. The cutter may be configured to switch between an active mode and a passive mode, wherein the cutting edge of the cutter extends through the window in the active mode and wherein the cutting edge of the cutter is retracted into the catheter in the passive mode. In the active mode, the cutter may be substantially parallel to the nose cone, and in the passive mode, the cutter may be substantially parallel to the elongated body. The cutting edge of the cutter may be maintained in the passive mode by a detent, which requires a threshold translational force applied to the rotatable drive shaft to release the detent and transition the cutter from the passive mode. The cutter may include an annular groove that provides clearance for the inner surface of the catheter. The cutter may be rotatable in both the active and passive modes. The cutter may include an imaging sensor configured to collect images of the exterior of the catheter when the cutter is in the active and passive modes. The catheter may include one or more openings configured to align with the imaging sensor and serve as position markers for the imaging sensor when the cutter is in the active mode. The angle of the fixed bend may be in the range of 1 to 30 degrees. When the cutter is extended through the cutting window, the central axis of the cutter may be angled in the range of 1 to 30 degrees relative to the central axis of the distal nose cone. The cutter may include a boss configured to slide along an edge within the lumen of the catheter to radially move the cutter and extend the cutter through the cutting window when the cutter and the rotatable drive shaft are moved proximally. The inner lumen of the catheter can define a first channel and a second channel, wherein the inclined edge in the inner lumen is configured to push the cutter from the first channel to the second channel when the cutter and the rotatable drive shaft move proximally. The cutter can be configured to move distally to pack tissue into the distal nose cone. The cutter can be configured to switch between being parallel to the nose cone and being parallel to the elongated body. The elongated body can include a flexible section disposed proximally relative to the fixed bend, wherein the curvature range of the proximal flexible section is adjustable. The flexible section can be configured to assume an S-shaped curved shape when the cutter and the rotatable drive shaft move further proximally within the catheter.

[0021] In some examples, an atherectomy device includes a catheter comprising a distal nose cone fixedly coupled to a flexible segment, and a cutter window located between the distal nose cone and the flexible segment, wherein the flexible segment includes a longitudinal ridge located on one side of the flexible segment; and a cutter coupled to a rotatable drive shaft within the catheter, wherein proximal movement of the cutter and the rotatable drive shaft causes the cutter to tilt in a first direction and extend through the cutter window, wherein a force applied to the rotatable shaft in a proximal direction causes the flexible segment to bend away from the longitudinal ridge and assume a curvature, and wherein distal movement of the cutter and the rotatable drive shaft causes the cutter to tilt in a second direction opposite the first direction and retract into the cutter window. The curvature range of the flexible segment can be adjusted based on the amount of force applied to the cutter and the rotatable drive shaft in the proximal direction. The proximal flexible segment can be configured to bend into an S-shape. The flexible segment can be configured to bend incrementally via proximal movement of the cutter and the rotatable drive shaft based on an amount of compression on the flexible segment. The cutter may include a boss configured to slide along an edge of the inner surface of the catheter to radially move the cutter and extend the cutter through the cutter window. The edge may be tilted relative to an axis perpendicular to the longitudinal axis of the distal nose cone. The edge may be configured to tilt the cutter relative to the nose cone when the boss of the cutter slides along the edge. The edge may be located on a hub of the catheter. The atherectomy device may further include a handle located at the proximal end of the catheter, wherein the handle includes a lock configured to lock the flexible segment into a curved shape having a selected range of curvatures. The lock may be configured to allow a user to select a locking position where the drive shaft is 0.026 inches or less relative to the catheter. The lock may include a slider button configured to slide distally and proximally. Sliding the slider button proximally may increase the curvature of the flexible segment. The slider button may include teeth configured to engage with corresponding teeth in the handle to lock the axial position of the drive shaft relative to the catheter. The handle may include a spring that applies pressure to the slider button to maintain engagement of the teeth of the slider button with corresponding teeth in the handle. The slider button can be configured to compress the spring when a user presses the slider button to disengage the teeth of the slider button from corresponding teeth within the handle. The handle can include a ridge joint that allows the slider button to translate axially relative to the drive shaft while allowing the drive shaft to rotate relative to the slider button. The flexible segment can include a first portion axially adjacent to a second portion, the first portion having a first longitudinal ridge and the second portion having a second longitudinal ridge, wherein the first longitudinal ridge and the second longitudinal ridge are located on opposite sides of the flexible segment, and wherein a force applied to the rotatable shaft in a proximal direction causes the first portion to bend laterally away from the first longitudinal ridge and the second portion to bend laterally away from the second longitudinal ridge.

[0022] In some examples, an atherectomy device includes a catheter including a nose cone fixedly coupled to an elongated body at a fixed bend of the catheter, wherein the catheter includes a cutter window located on a convex side of the fixed bend; and a cutter coupled to a rotatable drive shaft within the catheter, wherein proximal movement of the cutter and the rotatable drive shaft causes the cutter to tilt in a first direction and extend through the cutter window, and wherein distal movement of the cutter and the rotatable drive shaft causes the cutter to tilt in a second direction opposite the first direction and retract into the catheter. The cutter window may be located distally along the catheter relative to the fixed bend. The cutter may be configured to move radially when extending through the cutter window. When the cutter extends through the cutter window, at least a portion of the cutting edge of the cutter may correspond to a most protruding point along the convex side of the fixed bend. The cutter may be configured to switch between an active mode and a passive mode, wherein the cutting edge of the cutter extends through the cutter window in the active mode and wherein the cutting edge of the cutter is retracted into the catheter in the passive mode. In the active mode, the cutter can be substantially parallel to the nose cone, and in the passive mode, the cutter can be substantially parallel to the elongated body. The cutting edge of the cutter can be maintained in the passive mode by a detent, which requires a threshold translational force applied to the rotatable drive shaft to release the detent and transition the cutter from the passive mode. The cutter can be rotatable in both the active and passive modes. The cutter can include an imaging sensor configured to collect images of the exterior of the catheter when the cutter is in the active and passive modes. The catheter can include one or more openings configured to align with the imaging sensor and serve as position markers for the imaging sensor when the cutter is in the active mode. The angle of the fixed bend can be in the range of 1 to 30 degrees. When the cutter is extended through the cutter window, the central axis of the cutter is angled in the range of 1 to 30 degrees relative to the central axis of the distal nose cone. The cutter can include a boss configured to slide along an edge within the lumen of the catheter to radially move the cutter and extend the cutter through the cutter window when the cutter and the rotatable drive shaft are moved proximally. The inner lumen of the catheter defines a first channel and a second channel, wherein the inclined edge in the inner lumen is configured to push the cutter from the first channel to the second channel when the cutter and the rotatable drive shaft move proximally. The cutter can be configured to move distally to pack tissue into the distal nose cone. The cutter can be configured to switch between being parallel to the nose cone and being parallel to the elongated body. The elongated body can include a flexible segment disposed proximally relative to the fixed bend, wherein the curvature range of the flexible segment can be adjusted based on the proximal range of motion of the cutter and the rotatable drive shaft relative to the catheter. The flexible segment can be configured to exhibit an S-shaped bend when the cutter and the rotatable drive shaft move proximally within the catheter.The atherectomy device may further include a handle at the proximal end of the catheter, wherein the handle includes a lock configured to lock the flexible segment into a curved shape. The lock may be configured to allow a user to select a locking position of the drive shaft relative to the catheter of 0.026 inches or less. The lock may include a slider button configured to slide distally and proximally. Sliding the slider button proximally may increase the curvature of the flexible segment. The handle may include a ridge joint that allows the slider button to translate axially relative to the drive shaft while allowing the drive shaft to rotate relative to the slider button. The flexible segment may include a first portion axially adjacent to a second portion, the first portion having a first longitudinal ridge and the second portion having a second longitudinal ridge, wherein the first longitudinal ridge and the second longitudinal ridge are located on opposite sides of the flexible segment, and wherein a force applied to the rotatable shaft in a proximal direction causes the first portion to bend laterally away from the first longitudinal ridge and the second portion to bend laterally away from the second longitudinal ridge. The elongated body may include a flexible segment disposed proximally relative to the fixed bend, the flexible segment including a first portion axially adjacent to a second portion, the first portion having a first longitudinal ridge and the second portion having a second longitudinal ridge, wherein the first longitudinal ridge and the second longitudinal ridge are located on opposite sides of the flexible segment. Further proximal movement of the rotatable shaft may cause the flexible segment to compress, thereby causing the first portion to bend laterally away from the first longitudinal ridge and the second portion to bend laterally away from the second longitudinal ridge, thereby causing the flexible segment to assume an S-shape. The angle of the fixed bend may be in the range of approximately 1° to 30°.

[0023] In some examples, a method for using an atherectomy device includes a cutter coupled to a rotatable drive shaft within a catheter having a distal nose cone fixedly coupled to a flexible segment, and a cutter window located between the distal nose cone and the flexible segment. The method includes: proximally moving the rotatable drive shaft within the catheter to tilt the cutter in a first direction and extend through the cutter window; further proximally moving the rotatable drive shaft within the catheter to bend the flexible segment away from a longitudinal spine of the flexible segment, thereby imparting a curvature to the flexible segment; and distally moving the rotatable drive shaft within the catheter to tilt the cutter in a second direction opposite the first direction and retract the cutter into the catheter. The method may also include distally moving the rotatable drive shaft within the catheter to straighten the flexible segment. Moving the rotatable drive shaft distally may include sliding a slider button on a handle of the atherectomy device distally, wherein moving the rotatable drive shaft proximally includes sliding the slider button proximally. The method may also include proximally sliding the slider button on the handle of the atherectomy device to increase the curvature of the flexible segment. The method may further include selecting a range of curvatures for the flexible segment by controlling distal and proximal movement of a slider button. The method may further include locking the flexible segment into a curved shape of the selected curvature using a handle located at the proximal end of the catheter. Proximally moving the rotatable drive shaft to extend the cutter through the cutter window may include sliding a boss of the cutter along an edge of an inner surface of the catheter to radially move the cutter and extend the cutter through the cutter window. The edge may be inclined relative to an axis perpendicular to the longitudinal axis of the distal nose cone. The edge may be configured to tilt the cutter relative to the nose cone when the boss of the cutter slides along the edge. The cutter window may be located on a side of the catheter. The flexible segment may include a first portion axially adjacent to a second portion, the first portion having a first longitudinal ridge and the second portion having a second longitudinal ridge, wherein the first longitudinal ridge and the second longitudinal ridge are located on opposite sides of the flexible segment, and wherein further proximal movement of the rotatable drive shaft causes the first portion to bend laterally away from the first longitudinal ridge and the second portion to bend laterally away from the second longitudinal ridge, thereby causing the flexible segment to assume an S-shape. The method may further include rotating the rotatable drive shaft while capturing an image of the exterior of the catheter using an imaging sensor coupled to the rotatable drive shaft.The method may further include cutting tissue exterior of the catheter by rotating the rotatable drive shaft.

[0024] In some examples, a method for using an atherectomy device includes a cutter coupled to a rotatable drive shaft within a catheter, the catheter including a nose cone fixedly coupled to an elongated body at a fixed bend of the catheter. The method comprises: moving the rotatable drive shaft proximally within the catheter to tilt the cutter in a first direction and extend it through a cutter window; and moving the rotatable drive shaft distally within the catheter to tilt the cutter in a second direction opposite the first direction and retract it into the cutter window. The angle of the fixed bend can be in a range of approximately 1° to 30°. The cutter can move radially relative to the catheter while extending through the cutter window. When the cutter extends through the cutter window, at least a portion of the cutter's cutting edge can correspond to a most protruding point along a convex side of the fixed bend. The cutter's cutting edge can extend through the cutter window in an active mode, and wherein the cutter's cutting edge is retracted into the catheter in a passive mode. In the active mode, the cutter can be substantially parallel to the nose cone, and in the passive mode, the cutter can be substantially parallel to the elongated body. The cutting edge of the cutter can be retained in a passive mode by a detent, the method further comprising applying a threshold translational force to the rotatable drive shaft to release the detent and transition the cutter from the passive mode. The cutter can be rotatable in both the active and passive modes. The method can further comprise acquiring an image of the exterior of the catheter using an imaging sensor coupled to the rotatable drive shaft. The catheter can include one or more openings configured to align with the imaging sensor and serve as position markers for the imaging sensor. Moving the rotatable drive shaft proximally to extend the cutter through the cutter window can comprise sliding a boss of the cutter along an edge of an inner surface of the catheter to radially move the cutter and extend the cutter through the cutter window. The method can further comprise moving the cutter distally to pack tissue into the nose cone. Moving the rotatable drive shaft proximally within the catheter to tilt the cutter in a first direction and extend it through the cutter window can comprise transitioning the cutter between being parallel to the nose cone and being parallel to the elongated body. The elongated body can include a flexible segment disposed proximally relative to the fixed bend, the method further comprising moving the rotatable drive shaft proximally within the catheter to bend the flexible segment. The method may further include adjusting the curvature of the bend by controlling the extent of proximal movement of the rotatable drive shaft within the catheter. The flexible segment may be configured to exhibit an S-shaped bend as the rotatable drive shaft moves proximally within the catheter. The method may further include locking the flexible segment into a curved shape of a selected curvature using a handle located at the proximal end of the catheter. Moving the rotatable drive shaft distally may include sliding a slider button on a handle of the atherectomy device distally, wherein moving the rotatable drive shaft proximally includes sliding the slider button proximally. The method may further include sliding a slider button on the handle of the atherectomy device proximally to increase the curvature of the flexible segment of the elongated body.The method may further include locking the cutter in an active mode in which the cutter extends through the cutter window. Moving the rotatable drive shaft proximally may include pressing and moving a slider button on a handle of the atherectomy device proximally, wherein locking the cutter in the active mode includes releasing the slider button. The method may further include locking the cutter in a passive mode in which the cutter is retracted into the cutter window. Moving the rotatable drive shaft distally may include pressing and moving a slider button on a handle of the atherectomy device distally, wherein locking the cutter in the passive mode includes releasing the slider button. The method may further include rotating the rotatable drive shaft while capturing an image of the exterior of the catheter using an imaging sensor coupled to the rotatable drive shaft. The method may further include cutting tissue exterior of the catheter by rotating the rotatable drive shaft.

[0025] These and other aspects and advantages are described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The novel features of the present invention are specifically set forth in the claims. The specification lists some illustrative embodiments utilizing the principles of the present invention, including the principles utilized by the present invention. The features and advantages of the present invention can be better understood by referring to the specification and the accompanying drawings. In the accompanying drawings:

[0027] Figure 1A An atherectomy catheter with a fixed bump is shown.

[0028] Figure 1B Shown in blood vessels Figure 1A Atherectomy catheter.

[0029] Figure 2 Show Figure 1A Diagram of the relative angles and dimensions of atherectomy catheters.

[0030] Figure 3A A variation of the distal end of an atherectomy catheter is shown that includes a user-actuated bending portion having a stiffening member such that the catheter deforms into a predetermined curved configuration when actuated.

[0031] Figure 3B Show Figure 3A Schematic diagram of the reinforcement structure of the atherectomy catheter.

[0032] Figure 4A and 4B Another embodiment of an atherectomy catheter having a distal curved portion is shown.

[0033] Figure 5A is a top view of a user-actuated curved portion of an atherectomy catheter.

[0034] Figure 5B and5C yes Figure 5A Perspective view of the curved portion.

[0035] Figure 5D yes Figure 5A Flattened view of the curved portion of the .

[0036] Figure 6A Another embodiment of an atherectomy catheter including a user-actuated curved portion is shown.

[0037] Figure 6B Shown are annular ridges and longitudinal ridges Figure 6A The curved part of the frame.

[0038] Figure 6C Show Figure 6B Side view of the ridge.

[0039] Figure 6D Show Figure 6B Cross-section of the ridge.

[0040] Figure 6E yes Figure 6B Flattened view of the ridge.

[0041] Figure 7A A portion of an atherectomy catheter is shown including a fixed concave-convex section and a flexible section.

[0042] Figure 7B Show Figure 7A Flattened view of the curved section of the catheter.

[0043] Figure 8A An exemplary flexible nose cone for use with an atherectomy catheter is shown.

[0044] Figure 8B Show Figure 8A A flattened view of a portion of the nose cone.

[0045] Figure 9A Another embodiment of an atherectomy catheter including a user-actuated curved portion is shown. Figure 9A The catheter in is in a straightened configuration.

[0046] Figure 9B Shown in a bent or actuated configuration Figure 9A Atherectomy catheter.

[0047] Figure 9C yes Figure 9A Close-up view of the bottom of the curved portion of the catheter in the straightened configuration.

[0048] Figure 9D yes Figure 9A A close-up view of the top of the curved portion of the catheter in the straightened configuration.

[0049] Figure 9E is in a bent or actuated configuration Figure 9A Close-up of the curved section of the catheter.

[0050] Figure 9F is in a bent or actuated configuration Figure 9A Another close-up of the curved portion of the catheter.

[0051] Figure 10A A partial close-up cross-sectional view of a catheter is shown having a hub configured to guide movement of a cutter through a cutting window.

[0052] Figure 10B 、 10C and 10D show that as the cutter gradually moves across the cutting window, Figure 10A A partial close-up cross-sectional view of the catheter.

[0053] Figure 11A 、 11B 11C show a side view of a catheter having a flexible section configured to assume a curved shape.

[0054] Figure 12 Shown is a side view of another catheter having a flexible section configured to assume a curved shape.

[0055] Figure 13A Shown is a side view of a catheter with a fixed bend.

[0056] Figure 13B Show Figure 13A Close-up of the fixed bend of the catheter.

[0057] Figure 13C Show Figure 13A A partial close-up cross-sectional view of the catheter of FIG. 1 is shown with the cutter in passive mode.

[0058] Figure 13D Show Figure 13A A partial close-up cross-sectional view of the catheter of FIG. 1 is shown with the cutter in active mode.

[0059] Figure 13E Show Figure 13A A partial close-up cross-sectional view of a catheter of FIG. 1 is shown showing the cutter between passive mode and active mode.

[0060] Figure 14A A perspective view is shown of an example cutter and hub for use with a catheter having a fixed bend.

[0061] Figure 14B Show Figure 14A A cross-sectional view of the cutter and bushing.

[0062] Figure 14C Show Figure 14A A proximal perspective view of the bushing is shown.

[0063] Figure 14D Show Figure 14A A distal perspective view of the bushing is shown.

[0064] Figure 14E Show Figure 14A A cross-sectional view of the bushing is shown.

[0065] Figure 14F Show Figure 14A Another cross-sectional view of the bushing is shown.

[0066] Figure 14G Show Figure 14A A cross-sectional view of a cutter and bushing showing the pawl for holding the cutter in passive mode.

[0067] Figures 15A to 15C A cross-sectional view showing a portion of a handle having a slider lock for locking the axial position of the drive shaft relative to the catheter: Figure 15A The slide lock is shown engaged in a distal position; Figure 15B The slide lock is shown disengaged in a distal position; and Figure 15C The slide lock is shown engaged in the proximal position. DETAILED DESCRIPTION

[0068] This article describes an atherectomy catheter having an elongated body including a curved distal portion, a nose cone, and a rotatable annular cutter. The curved portion (also referred to as a curved / bendable portion or a concave-convex mechanism) can be advantageously used to push the cutter against the vessel wall to improve cutting efficiency.

[0069] Figure 1A and 1B An exemplary atherectomy catheter 100 is shown including a curved portion along an elongated catheter body. Figures 1A to 2 The atherectomy catheter 100 may include a catheter body 101 having a curved portion 133, a rotatable annular cutter 103 located at a distal end of the catheter body 101, and a nose cone 105 located at the distal end of the catheter body 101. The nose cone 105 may include a cutting window 107 configured to allow the cutter 103 to cut therethrough. The catheter 101 may also include a curved portion 133 located in the catheter body 101 to radially urge the cutter 103 against the vessel wall.

[0070] The curved portion 133 may be a fixed relief (i.e., having a preset shape). Furthermore, the curved portion may be curved or bent such that the cutting window 107 is located radially outwardly of the curved portion 133 (thus allowing the cutting window 107 to be pushed against the vessel wall during use). In one embodiment, the curved portion 133 may be preformed, for example, using a pre-deflected, shape-setting nitinol strip segment embedded in the outer shaft. The curved portion 133 may have a shape that advantageously positions the cutter 103 relative to the vessel wall for cutting. In some cases, the curved portion 133 may have two inflection points 155, 166 of opposite curvature (i.e., one curving upward and the other curving downward) to form an approximately "S" shape. In one embodiment, the S-shape may be configured such that the distal end of the catheter body 101 deviates from, but is substantially parallel to, the proximal end of the catheter body 101. In other embodiments, the distal and proximal ends of the catheter body 101 may be at a slight angle relative to each other to control the angle at which the cutter engages the vessel wall.

[0071] Therefore, if Figure 2 As shown, the "S-shape" of curved portion 133 can include a proximal segment 137 having a length b extending from the center of distal inflection point 155 to the center of proximal inflection point 166. Furthermore, curved portion 133 can include a distal segment 135 having a length a extending from cutting edge 112 to the center of distal inflection point 155. Furthermore, distal angle 1 can be defined at the distal end of the "S-shape" and proximal angle 2 can be defined at the proximal end of the "S-shape." These lengths (a, b) and angles (1, 2) can be adjusted to achieve a desired concavity or offset for optimal tissue wall adhesion. For example, length a can be shorter than length b to ensure the cutter is as close to angle 1 as possible, thereby providing better adhesion of cutter 303. Angles 1 and 2 can be between 120 and 180 degrees, such as between 140 and 160 degrees. In one example, length a is between 5 mm and 10 mm, length b is between 10 mm and 15 mm, angle 1 is 140 degrees, and angle 2 is 160 degrees for a 2.5 to 4 mm diameter catheter configured for use in a blood vessel.

[0072] The curved portion 133 can advantageously push the distal end of the catheter radially against the vessel wall 200, thereby achieving optimal cutting and / or imaging of the vessel, such as Figure 1B shown.

[0073] Figures 3A to 3B Another embodiment of an exemplary catheter 300 is shown, including a curved portion 333 located in the catheter body that propels the atherectomy cutter against the vessel wall. The dimensions and features of the curved portion 333 can be similar to those of the curved portion 133. However, unlike the fixed concave-convex curved portion 133 of the catheter 100, the curved portion 333 can be a user-actuated concave-convex. Thus, see Figure 3A and 3B , the catheter 300 can be deflected into the curved portion 333 by the telescopic interaction between the inner shaft 313 (which can be a drive shaft for a cutter) and the outer shaft 311, which are fixed together at the distal end but are free to move relative to each other at the proximal end. The outer shaft 311 can include stiffening members 377a, 377b, such as nitinol or stainless steel, which are configured to bias the deflection into a set shape. Figure 3B As shown, there can be two reinforcing members 377a, 377b, which can be axially aligned with the outer shaft 311 and axially and radially offset from each other. Therefore, when compression is applied to the outer shaft 311 (such as by pulling the inner shaft 313 or a separate pull line or shaft), the parts 379a, 379b of the outer shaft relative to the reinforcing members 377a, 377b will shrink. The shrinkage of the two parts 379a, 379b will produce an S-shape similar to the catheter 100 shown in Figure 1. As a result, the catheter will be deflected into a concave-convex or S-shaped configuration, wherein the distal end of the shaft is offset and parallel to the main shaft body. It should be understood that other numbers and arrangements of reinforcing members are also possible, and other concave-convex shapes may also be formed.

[0074] Figures 4A to 4B Another embodiment of an atherectomy catheter 400 including a user-actuated curved portion 433 is shown. The atherectomy catheter 400 includes an elongated body 401, a nose cone 405 attached to the elongated body 401, and a cutting window 407 configured to expose an annular cutter 411 therethrough. In addition, the catheter 400 includes a curved portion 433. The curved portion 433 includes curved segments 425, 426 having opposite curvatures (i.e., one curved upward and the other curved downward) to form an approximately S-shape. In one embodiment, the S-shape can be configured such that the distal end of the catheter body 401 and / or the nose cone 405 deviates from but is substantially parallel to the proximal end of the catheter body 401. In another embodiment, the distal end of the elongated body 401 and / or the nose cone 405 form a certain angle relative to the proximal end of the catheter body 401.

[0075] Therefore, if Figure 4BAs shown, the "S-shape" of the concave-convex portion 433 can include a proximal curved segment 426 and a distal curved segment 425 having a length c. Furthermore, the distal end of the "S-shape" can have a distal angle 1, and the proximal end of the "S-shape" can have a proximal angle 2. The lengths (c, d) and angles (1, 2) of the concave-convex portion 433 can be adjusted to achieve a desired concave-convex or offset for optimal tissue wall adhesion. For example, angles 1 and 2 can be between 120 and 175 degrees, such as between 140 and 160 degrees. Furthermore, in some embodiments, the length d of the proximal segment 426 is greater than the length c of the distal segment 425. In one example, the length c is 5 mm, the length d is 8 mm, and the angles 1 and 2 are 150 degrees, for a catheter configured for use in a blood vessel with a diameter of 2.5 to 4 mm. The curved portion 433 can be configured to assume an S-shape during use of the catheter, as described above with respect to the curved portion 333.

[0076] Figures 5A to 5D An exemplary user-actuated curved portion 533 (e.g., used as curved portion 433) is shown in FIG. Curved portion 533 may include a frame (e.g., made of nitinol or stainless steel) comprising a series of circumferential slits 550 (e.g., laser cuts) patterned within curved segments 525, 526 along the circumference of elongated body 501. The frame of curved segments 525, 526 may further include longitudinal ridges 560a, 560b (also referred to herein as backbones) extending therethrough. Longitudinal ridges 560a, 560b may be positioned approximately 180 degrees apart from one another (i.e., on opposite sides of elongated body 501) and extend substantially parallel to the longitudinal center axis of elongated body 501. The frame may further include a circumferential ridge 561 separating the two curved segments 525, 526. Each ridge 560a, 560b, and 561 is formed from a substantially solid sheet of material that does not include slits. In use, as the circumferential slits 550 compress and / or overlap each other during bending, the longitudinal ridges 560a, 560b form the backbone of the curved segments 525, 526. Additionally, in some embodiments, the frame can be laminated with upper and / or lower layers, such as a thin polymer layer, such as Tecothane. In other embodiments, the frame is not laminated to provide greater flexibility.

[0077] Reference Figure 5D, the slits 550 can be arranged in a pattern that is configured to provide flexibility while maintaining the structural integrity of the elongated body. Therefore, most of the slits 550 can have the same length, but offset from each other. For example, the slits in the distal segment 525 can be arranged in rows (1, 2) and columns (A, B). Each slit 550 (except for the shorter slits adjacent to the ridge 560a) can have a length equal to the width of column A+B+A. In addition, the slits can be offset from each other by a distance A+B. Therefore, each column A can include a slit from each of rows 1 and 2, while column B can include alternating slits (from either row 1 or row 2). Therefore, column B provides structural integrity for the slit portion of the device. The slits in segment 526 can be arranged similarly, but can be offset so that each column C (having a slit from each of rows 3 and 4) is aligned with the central axis of each column D (having a slit from either row 3 or row 4). The offset helps provide stability when the catheter is bent.

[0078] In some examples, pushing or pulling a shaft of the catheter, such as a cutter drive shaft, a puller shaft, or a pull wire, can actuate the curved portion 533. That is, as the shaft is pulled back proximally, it can place shaft compression on the outer elongated body 501, causing the slits 550 to compress against each other and / or move up and down while the ridges 560a, 560b maintain their length. The resulting S-shape (see FIG. Figure 4B ) allows the cutter (located just distal to ridge 460a) to be pushed upward against the vessel wall.

[0079] Figures 5A to 5D The slits 550 are shown as having a repeating symmetrical pattern. However, the pattern need not be symmetrical. In some embodiments, the slits can all be the same length. In other embodiments, some slits are longer than others. In one embodiment, the slits are 0.0016" wide, 0.0575" long, and offset from the next row of slits by 0.0035".

[0080] Areas of the catheter body with a higher degree of slits will be more flexible than areas with a lower degree of slits. In one embodiment, the slits can extend all the way through the elongated catheter. In other cases, some slits can be deeper or shallower than other slits, which can also affect the flexibility of the corresponding areas. In some variations of the curved portion, a range of deflection between flexible segments can be achieved. This can be achieved through different geometric patterns of slits, different spacing of slits, slit frequency, slit size, etc. In some cases, the degree of stiffness can be adjusted by adding additional ridges of various lengths in certain areas or adjusting the width of the ridges.

[0081] Reference Figures 6A to 6E, another exemplary curved portion 633 (e.g., used as curved portion 433) is shown. Curved portion 633 includes a frame having three annular ridges 661a, 661b, 661c connected together by two longitudinal ridges 660a, 660b. The longitudinal ridges 661a, 661b, 661c can be separated by about 180 degrees from each other. In some embodiments, the distal rings 661a, 661b, 661c can have a bevel at the distal end, such as Figure 6C As shown, to allow the nose cone 605 to fall or pivot. In addition, the space between the annular ridges 661a, 661b, 661c and the longitudinal ridges 660a, 660b can be open or cut (i.e., not including frame material). In some embodiments, the frame can be laminated to the elongated body 601 using one or more thin polymer layers (e.g., Tecothane). The rings 661a, 661b, 661c may include holes for welding or laminating the mechanism 633 to the elongated body of the catheter. In other embodiments, the frame can remain unlaminated to provide greater flexibility. When compression is applied to the mechanism 633, the mechanism 633 can bend away from each ridge 660 to form an s-shape. For example, compression can be applied to the mechanism 633 by pulling the drive shaft proximally.

[0082] See also Figures 9A to 9F , shows another exemplary atherectomy catheter 900 having a curved portion 933. Similar to atherectomy catheter 100, atherectomy catheter 900 may include a catheter body 901 having a curved portion 933, a rotatable annular cutter 903 located at the distal end of catheter body 901, and a nose cone 905 located at the distal end of catheter body 901. Catheter body 901 and / or nose cone 905 may also include a cutting window 907 configured to allow cutter 903 to cut therethrough. Catheter 900 may also include a drive shaft (not shown) attached to cutter 903 and configured to rotate cutter 903 when actuated. In this embodiment, nose cone 905 is not hinged relative to elongated body 901. Instead, a hub 991 of elongated body 901 is directly attached to the proximal end of nose cone 905. The absence of a hinge may advantageously prevent nose cone 905 from becoming lodged within a blood vessel. In this embodiment, proximal or distal movement of cutter 903 and the drive shaft can actuate curved portion 933 to radially urge cutter 903 against the vessel wall (eg, outside of cutting window 907).

[0083] The curved portion 933 comprises a tubular frame having a proximal segment 992a and a distal segment 992b. Each segment 992a, 992b comprises a longitudinal ridge 960a, 960b, respectively. The longitudinal ridges 960a, 960b are arranged approximately 180 degrees apart from each other. The longitudinal ridges 960a, 960b are arranged to define tongue elements 965a, 965b, 965c (see FIG. Figure 9C) can be positioned opposite each ridge 960a, 960b in a circumferential cutout 947 (e.g., a laser cut) of the puzzle pattern. In some embodiments, the puzzle pattern includes a hole 975, and the cutout 947 terminates at the ridge 960a, 960b in the hole 975. When compression is applied to the mechanism 933, the mechanism 933 can bend into an S-shape, wherein the proximal segment 992a bends in a first direction and the distal segment 992b bends in an opposite second direction. Figure 9F As shown, during such bending, the ridges 933c do not compress, thereby forming the outer diameter of each respective bend, and the cutouts 947 compress together to form the inner diameter of each respective bend.

[0084] In some embodiments, the tongue elements 965a, 965b, 965c can have a tapered structure that is configured to indicate the amount of deflection of the curved portion 933 in two directions. For example, the tongue elements 965a, 965b, 965c can lock relative to each other in a bent position, thereby maintaining alignment of the curved portion 933 when in the bent or deflected position and resisting twisting when subjected to twisting forces. This can also prevent the curved portion 933 from overbending.

[0085] In some embodiments, proximal segment 992a can be longer than distal segment 992b. For example, proximal segment 992a can form 60 to 90%, such as 65 to 70%, of the length of curved portion 933, while distal segment 992b can form 10 to 40%, such as 30 to 35%, of the length of curved portion 933. Having distal segment 992b longer than proximal segment 992a can advantageously help ensure that cutter 903 is pressed against the vessel wall during use and does not tilt back toward the center of the vessel.

[0086] Curved portion 933 may be coupled to the outer shaft of the atherectomy catheter using any technique, such as welding, adhesives, fastener(s), or a combination thereof (eg, via hole 907 ).

[0087] See also Figures 10A to 10DIn any of the embodiments described herein, the cutter 1003 can include a proximal boss 1011 configured to interact with a bushing 1091 on the curved portion 1033 when the drive shaft 1013 is pulled proximally. The curved portion 1033 can correspond to a flexible section of the catheter. In embodiments where the nose cone 1005 is not hinged, the interaction between the proximal boss 1011 and the bushing 1091 can cause the cutter 1033 to move through the window 1007. For example, the distal edge 1015 of the bushing 1091 can be angled such that when the drive shaft 1013 is pulled proximally, the boss 1011 slides along the inclined distal edge 1015 (e.g., inclined relative to an axis perpendicular to the longitudinal axis of the nose cone 1005) to move the cutter 1003 out of the cutter window 1007 (see FIG. 10B ). Figures 10A to 10D That is, the interaction between the boss 1011 and the edge 1015 can cause at least a portion of the cutter to extend through (e.g., pop out) the window 1007 and tilt the cutter 1003 relative to the nose cone 1005 and the elongated body (e.g., Figure 9A and 9B In other words, proximal movement of the cutter 1033 relative to the nose cone can extend at least a portion of the cutter through the window and cause the longitudinal axis of the cutter 1033 to become non-parallel to the longitudinal axis of the nose cone 1005 and the elongated body. In some embodiments, when the cutter 1003 is fully deployed, the angle of the longitudinal axis of the cutter 1033 relative to the longitudinal axis of the nose cone 1005 and the elongated body is in the range of approximately 1 to 30 degrees (e.g., 1 to 30 degrees, 5 to 30 degrees, 20 to 30 degrees, 1 to 20 degrees, or 10 to 20 degrees).

[0088] In some embodiments, the interaction between the proximal boss and the bushing can additionally or alternatively cause the curved portion (also known as the flexible segment) to assume its S-shape. Figures 11A to 11C , pulling the drive shaft 1113 proximally (shown cut away for clarity) can engage the cutter 1103 with the bushing 1191 to apply compression to the curved portion 1033 and force the curved portion 1133 to bend (i.e., away from each of the longitudinal ridges 1160a, 1160b). In some embodiments, the amount of curvature can be incrementally and / or continuously adjusted by applying varying amounts of compression to the curved portion 1133 via the drive shaft. Similarly, pushing the drive shaft 1113 distally can straighten the curved portion 1133. A locking mechanism, such as a mechanism on the handle, can secure the curved portion 1133 at a desired amount of curvature. Referring below to Figures 15A to 15C One example of a handle having a locking mechanism is described.

[0089] In some embodiments, the cutter 1003 is pulled proximally a first degree and / or a first time such that a portion of the cutter 1003 extends through the window 1007 and is tilted relative to the nose cone and the elongated body (e.g., Figures 10A to 10D ), and the cutter 1003 is pulled proximally a second degree and / or a second time to cause the flexible portion to bend and assume an S-shape to varying degrees (e.g., Figures 11A to 11C shown).

[0090] See also Figure 12 In some embodiments, pulling the cutter 1203 proximally (e.g., via a drive shaft) can initially eject the cutter 1203 from the cutter window 1207. Pulling the cutter 1203 further proximally can then cause the curved portion 1233 to assume a desired S-shape (e.g., in a continuously adjustable manner). Initially ejecting the cutter 1203 from the window can advantageously ensure that the cutter 1203 can be fully extended, regardless of the assumed curvature. Pushing the cutter distally can straighten the curved portion 1233 to a desired degree. Further pushing the cutter 1203 distally can retract the cutter 1203 into the window 1207.

[0091] See also Figure 13A and 13B , nose cone 1305 can be fixedly coupled to or integrally formed with elongated body 1301 at a fixed angle θ relative to the elongated body. This fixed angle can form a fixed bend 1325 (also referred to as a fixed curve) in the catheter located between nose cone 1305 and elongated body 1301. A cutting window 1307 can provide access to the catheter lumen housing cutter 1303. Cutting window 1307 can be located at or near fixed bend 1325. In some embodiments, cutting window 1307 is positioned distally along the catheter relative to the curve. Cutter 1303 can be configured to extend through cutting window 1307 when cutter 1303 and the drive shaft are translated relative to the catheter (i.e., nose cone and elongated body). For example, the drive shaft and cutter 1303 can be pulled to move cutter 1303 proximally and extend cutter 1303 through the cutting window. Likewise, the drive shaft and cutter 1303 can be pushed to move the cutter 1303 distally and to retract the cutter 1303 into the catheter housing.

[0092] Cutting window 1307 can be located on the convex side 1350 of the catheter formed by the bend (e.g., opposite the concave side 1351 of the catheter formed by the bend). This configuration allows the rotating cutter 1303 to better access material outside the catheter for cutting. The angle θ of bend 1325 can vary. In some embodiments, angle θ ranges from approximately 1 degree to 30 degrees (e.g., 1° to 30°, 5° to 30°, 20° to 30°, 1° to 20°, or 10° to 20°). Thus, in some embodiments, the angle of bend 1325 at the convex side 1350 of the catheter can range from approximately 181° to 210° (e.g., 181° to 210°, 186° to 210°, 200° to 210°, 186° to 200°, or 190° to 200°).

[0093] The elongated body 1301 may include the Figures 11A to 11C and Figure 12 The flexible segment 1333 may be incrementally and / or continuously adjustable to assume an S-shape that changes in degree depending on the amount of proximal movement of the drive shaft relative to the nose cone 1305 and the elongated body 1301. The flexible segment 1333 may have greater flexibility than the nose cone 1305, the bend 1325, and in some cases, the remainder of the catheter.

[0094] Figures 13C to 13E A partial close-up cross-sectional view of bend 1325 is shown. Cutter 1303 can be configured to operate in a passive mode (e.g., Figure 13C ) and active mode (as shown Figure 13D shown). Figure 13E Shown in passive mode ( Figure 13C ) and active mode ( Figure 13D ) between the cutter 1303.

[0095] See also Figure 13CWhen cutter 1303 is in passive mode, cutting edge 1312 of cutter 1303 can be positioned distally relative to window 1307 and contained within nose cone 1305, such that cutting edge 1312 of cutter 1303 is completely protected and does not extend through cutting window 1307. In passive mode, cutting edge 1312 can be prevented from cutting material external to the catheter, thereby preventing cutting edge 1312 from cutting tissue, such as a blood vessel wall. For example, cutter 1303 can be placed in passive mode while the catheter is being maneuvered through a blood vessel to reach a target location within the vessel (e.g., to remove material such as plaque) and / or withdrawn from the vessel (e.g., after removing material from the vessel). In passive mode, the longitudinal axis (e.g., the axis of rotation) of cutter 1303 can be substantially parallel to the longitudinal axis of nose cone 1305. In passive mode, cutter 1303 can be pushed distally toward nose cone 1305, for example, to encapsulate material (e.g., plaque) within nose cone 1305.

[0096] See also Figure 13D , when the cutter 1303 is in the active mode, the cutting edge 1312 of the cutter 1303 can extend through the cutting window 1307. On the convex side of the catheter, the cutter 1303 (e.g., the cutting edge 1312 of the cutter 1303) can extend beyond the outer wall so that the cutter 1303 can effectively access material outside the catheter for cutting. For example, when the cutter 1303 is extended through the cutting window 1307 (e.g., fully extended in the active mode), at least a portion of the cutter 1303 (e.g., at least a portion of the cutting edge 1312) can correspond to the most prominent feature or point along the convex side of the curve. In the active mode, the longitudinal axis (e.g., the rotational axis) of the cutter 1303 can be substantially parallel to the slender body (e.g., the axis of rotation). Figure 13A Since the cutter 1303 can be parallel to the elongated body, the cutter 1303 can be at an angle θ ( Figure 13B ).

[0097] Figure 13E 13. The cutter 1303 is shown between a passive mode and an active mode. The cutter 1303 and the drive shaft can be moved proximally (e.g., pulled away from the nose cone 1305) to switch the cutter 1303 from the passive mode to the active mode. Similarly, the cutter 1303 and the drive shaft can be moved distally (e.g., advanced toward the nose cone 1305) to switch the cutter 1303 from the active mode to the passive mode. During the transition between the passive and active modes, the cutter 1303 can be configured to interact with an inner surface within the catheter to adjust the position and orientation of the cutter 1303 relative to the nose cone 1305 and the elongated body 1301.

[0098] For example, during a transition from the passive mode to the active mode, the cutter 1303 is pulled proximally (e.g., via a drive shaft) such that the proximal boss 1311 (also referred to as the proximal side) of the head 1390 of the cutter 1303 slides along the distal edge 1315 of the bushing 1391. This interaction causes the cutter 1303 to move radially outward relative to the central axis of the elongated body 1301 and extend through the cutting window 1307 (e.g., pop out of the window). This interaction also causes the cutter 1303 to tilt such that the longitudinal axis of the cutter 1303 is aligned with (e.g., becomes substantially parallel to) the longitudinal axis of the elongated body 1301.

[0099] During the transition from the active mode to the passive mode, the cutter 1303 is pushed distally (e.g., via a drive shaft) such that the inclined surface 1370 along the shaft 1385 of the cutter 1303 slides along the inner edge 1371 of the bushing 1391, causing the cutter 1303 to move radially inward relative to the central axis of the elongated body 1301 and retract into the catheter. As the cutter 1303 moves radially inward, the shaft 1385 of the cutter 1303 contacts the inner surface 1383 of the bushing 1391, causing the cutter 1303 to tilt such that the longitudinal axis of the cutter 1303 is aligned with (e.g., becomes substantially parallel to) the longitudinal axis of the nose cone 1305.

[0100] The transition between passive and active modes can be continuous, wherein the cutter 1303 gradually translates, tilts, and moves radially. The cutter 1303 and the drive shaft can freely rotate while in the passive and active modes. In some cases, the cutter 1303 can also freely rotate while transitioning between the passive and active modes.

[0101] The lock mechanism of the handle can be used to lock the cutter 1303 in either passive mode or active mode. Figures 15A to 15C An example of a locking mechanism is described.

[0102] Any catheter described herein may include imaging capabilities such as those described in International Applications PCT / US2017 / 040431 and PCT / US2019 / 028415, each of which is incorporated herein by reference in its entirety. For example, cutter 1303 may include a cavity 1363 for an imaging sensor within the catheter to send and / or receive image data as part of an imaging system. Cutter 1303 may be configured to collect imaging data in a passive mode, an active mode, and / or during active and passive mode conversions. In some embodiments, the catheter includes one or more openings 1399 for position markers of (one or more) additional windows and / or imaging sensors.

[0103] Figure 14A and 14BPerspective and cross-sectional views of an example cutter 1403 and bushing 1491 are shown. Cutter 1403 may include a head 1490 at a distal end, a neck 1481, and a cylindrical shaft 1485 at a proximal end. The head 1490 may include an annular cutting edge 1412, which in some embodiments may be scalloped. The diameter of the neck 1481 may be smaller than the diameter of the head 1490 and the proximal shaft 1485 to provide clearance for the cutter 1403 when rotating in an active mode. In some embodiments, the shaft 1485 may include an annular groove 1487 that cooperates with the bushing 1491 to act as a detent (described in detail below). The bushing 1491 may be fixedly coupled to and positioned at the distal nose cone (e.g., Figure 13A 1305) and the proximal elongated body (e.g. Figure 13A In some cases, bushing 1491 is welded to the nose cone and / or the elongated body. Bushing 1491 may include a first portion 1482 substantially parallel to the nose cone and a second portion 1486 substantially parallel to the elongated body. An intermediate portion 1484 may be located between first portion 1482 and second portion 1486.

[0104] As described above, features of the bushing 1491 can interact with the cutter 1403 to control the movement of the cutter 1403 between the active mode and the passive mode. When the cutter 1403 is pulled proximally (e.g., from the passive mode to the active mode), the proximal boss 1411 (also called the proximal side) of the head 1490 of the cutter 1403 can be configured to slide along the distal edge 1415 of the bushing 1491. This interaction causes the cutter 1403 to move radially outward and extend through the cutting window. The cutter 1403 becomes disposed within a recess 1416 (also called a seal or indentation) in the distal side of the bushing 1491, which provides space for the proximal boss 1411 of the cutter 1403 to rotate in the active mode. Figure 14A As shown, distal edge 1415 may form a crescent-shaped step relative to cylindrical head 1490 of cutter 1403 .

[0105] See also Figure 14B , bushing 1491 may include an inner edge 1471 that is configured to cause cutter 1403 to slide along angled surface 1470 when the cutter is pushed distally (e.g., from an active mode to a passive mode), thereby moving cutter 1403 radially inward. Additionally, inner surface 1483 of bushing 1491 contacts shaft 1485 of cutter 1403, causing cutter 1403 to tilt and move into alignment with and retract into the nose cone, as described above.

[0106] Figures 14C to 14FAn alternative view of the bushing 1491 is shown showing the proximal side of the bushing ( Figure 14C ), distal ( Figure 14D ) and sectional views ( Figure 14E and 14F ). The proximal opening 1441 of the bushing can have an elliptical shape, thereby providing clearance for the shaft of the cutter when switching between the active mode and the passive mode. The inner surface of the bushing can be formed with a first channel 1443 for the cutter in the passive mode, and a second channel 1445 for the cutter in the active mode. The first channel 1443 and the second channel 1445 can be configured to maintain the cutter at different angles based on whether the cutter is in the passive mode or the active mode. The first channel 1443 can maintain the cutter in alignment with the nose cone (e.g., parallel), and the second channel 1445 can maintain the cutter in alignment with the elongated body (e.g., parallel). The first distal surface 1415 can be located on the protruding lip 1442 at the distal end of the bushing. As described above, the first distal surface 1415 of the bushing can slide along the angled surface of the proximal side of the cutter head to advance the cutter from the passive mode to the active mode. As also described above, the surface 1471 of the bushing can slide along the angled surface along the cutter shaft to advance the cutter from the active mode to the passive mode.

[0107] As described above, cutter 1403 can be maintained in the passive mode by a detent mechanism. Figure 14G Annular groove 1487 is shown on the shaft 1485 of cutter 1403, and annular groove 1487 provides gap 1489 (also called spacing) between the protruding surface 1442 of cutter and bushing. When in passive mode, annular groove 1487 is aligned with inner surface 1442, and when the cutting edge of cutter is contained in the catheter, gap 1489 allows cutter to rotate more freely. This configuration can be used as a detent to keep cutter 1403 in passive mode. For example, when the cutter is pushed toward the nose cone more distally (for example, during filling the nose cone with material), or when the cutter 1403 is pulled toward the proximal side during the process of switching to active mode, groove 1487 is not aligned with inner surface 1442. This causes the portion of shaft 1485 located on both sides of groove 1487 to contact the inner surface 1442 of bushing 1491, thereby increasing the resistance (friction) between cutter 1403 and bushing 1491. A threshold translational force may need to be applied to cutter 1403, either in the distal or proximal direction, in order to release the pawl holding cutter 1403 in the passive mode.

[0108] In some embodiments, any of the atherectomy devices described herein may not include imaging capabilities.

[0109] See also Figure 7A and 7BIn some embodiments, the atherectomy catheter 700 may include a curved portion 777, which includes a fixed concave-convex section 707 and a flexible section 717. The fixed concave-convex section 707 may be close to the flexible section 717 (as shown in the figure) or away from the flexible section 717. In some embodiments, the fixed concave-convex section 707 is longer than the flexible section 717. For example, the fixed concave-convex section 707 may be 5 to 10 mm, such as 8 mm, and the flexible section 717 may be 2 to 6 mm, such as 5 mm. In addition, in some embodiments (as shown in the figure), the fixed concave-convex section 707 may include only a single bend instead of a double bend (for example, forming a C-shape instead of an S-shape). The angle of the bend may be, for example, 120° to 175°, such as 130° to 160°, such as approximately 145°. The flexible section 717 may be configured to bend passively during use (ie under the action of the container wall), for example to form an angle between 90° and 180°, such as 110° to 170°, such as 130° to 160°.

[0110] In some embodiments, the curved portion 777 can be made of a laminate frame. Figure 7B , the curved portion 777 may include a frame having a plurality of circumferential slits 750a, 750b extending therethrough. The slits 750a of the flexible segment 717 may extend completely around the circumference (i.e., there are no longitudinal ridges therein), while the slits 750b of the fixed convex and concave segment 707 may terminate at a longitudinal ridge 760 extending through the fixed convex and concave segment 707. An annular ridge 761 may separate the flexible segment 717 and the fixed convex and concave segment 707. The frame may be made of, for example, Nitinol or stainless steel. In addition, one or both sides of the frame may be laminated with a thin layer of polymer, such as Tecothane. In some embodiments, only the fixed convex and concave segment 707 is laminated, while the flexible segment 717 remains unlaminated.

[0111] Reference Figure 7B, the slits 750a, 750b can be arranged in a pattern that is configured to provide flexibility in the flexible section 717 while maintaining the structural integrity of the elongated body in the flexible section 717 and the fixed concave-convex section 707. Therefore, most of the slits 750a, 750b can have the same length, but offset from each other. For example, the slits 750a of the flexible section 717 can be arranged in rows (1, 2) and columns (A, B). Each slit 750a has a length equal to the width of column A+B+A. In addition, the slits can be offset from each other by a distance A+B. Therefore, each column A can include a slit from each row in row 1 and row 2, while column B can include alternating slits (from row 1 or row 2). Therefore, column B provides structural integrity for the slit portion of the device. The slits 750a of the flexible section 717 can provide flexibility to allow the catheter 700 to achieve a desired curvature in any direction when located inside the body (i.e., the slits can be stretched outside the bend and compressed and / or overlapped inside the bend). For example, the flexible section 717 may be bent to align the cutter with the edge of the container.

[0112] Furthermore, the slits 750b of the fixed relief segment 707 (except for the shorter slits adjacent to the ridge 560a) can also have a length equal to the width of column A+B+A. Furthermore, the slits can be offset from each other by a distance A+B. Thus, each column A can include slits from each of rows 1 and 2, while column B can include alternating slits (from either row 1 or row 2). However, in the fixed relief segment 707, the ridge 760 can be heat-set to set the relief angle, thereby fixing the relief.

[0113] The curved segments described herein may additionally or alternatively include any of the selectively curved support features described in International Application No. PCT / US2019 / 028415 (the '415 application), which is incorporated herein by reference in its entirety. In some embodiments, the selectively curved support features described in the '415 application can be modified to take an S-shape as described herein, such as by including ridges on opposite sides of the shaft. Additionally, in some embodiments, the selectively curved support features described in the '415 application can be modified to actuate by compression (e.g., by pulling on a drive shaft of an atherectomy catheter as described herein) rather than via tension.

[0114] In some embodiments, the curved portion of the elongated catheter body described herein can form a roughly S-shape with two different inflection points of opposite curvature. In other embodiments, the curved portion can include a single inflection point forming a roughly C-shape. In addition, in some embodiments, one or more bends can be fixed. In other embodiments, one or more bends can be user-actuated (e.g., by pulling a drive shaft or a separate traction shaft or wire). In addition, any design described herein can include a flexible segment (e.g., of the elongated body or nose cone) that allows the catheter to adopt a desired curvature when in use.

[0115] In some embodiments, the amount of bend in the user-adjustable bend can be further adjusted before or during atherectomy based on the curvature of the artery and the location of plaque formation. For example, by tightening the catheter shaft, the bend can be contracted and adopt a sharper angle. Alternatively, when the shaft is relaxed, the bend can be relaxed and adopt a wider angle. In such examples, the deflection angle can be adjusted, for example, from 5 to 20 degrees. Furthermore, as described herein, the shape and angle can be adjusted incrementally and / or continuously.

[0116] In some embodiments, the user-adjustable curved portion may have a pre-formed curve or curvature that may be further adjusted before or during atherectomy. In other embodiments, the curved portion may be straight before the user-actuated curve is actuated.

[0117] In any embodiment described herein, the nose cone can be configured to retain tissue debulked by the cutter.In addition, the drive shaft and cutter are configured to move distally to pack tissue into the nose cone.

[0118] In some embodiments, lamination of the frame can cause the laminate to heat and contract, pushing into the open slit and fixing the shape of the frame (e.g., in a pre-formed relief). For example, curved portions 533 and / or 633 can be laminated to form a fixed relief segment that can be further adjusted by pulling the drive shaft, or remain fixed throughout the procedure. In other embodiments, lamination of the frame can keep the slit open and free of material, allowing for greater flexibility.

[0119] Although described herein as being actuated by compression (eg, pulling on a drive shaft), the flexures described herein may alternatively be actuated by tension (eg, pushing on a drive shaft).

[0120] Atherectomy catheters having a curved portion as described herein advantageously allow for easier and closer positioning of an atherectomy cutter near a plaque in an inner arterial wall. That is, the curved portion can be configured to move an exposed portion of the cutter (e.g., the area extending through the cutter window) closer to the vessel wall than an unexposed side of the cutter. This positioning can make cutting during an atherectomy procedure more efficient.

[0121] Any of the curved portions described herein can be used alone or in combination with a mechanism for deflecting the nose cone. In some embodiments, the nose cone can be deflected by pulling on the cutter drive shaft. Such deflection mechanisms are described in U.S. patent application Ser. No. 15 / 072,272, filed on March 16, 2016 (now U.S. Patent No. 9,592,075), entitled “ATHERECTOMY CATHETERS DEVICES HAVING MULTI-CHANNEL BUSHINGS,” and U.S. patent application Ser. No. 15 / 076,568, filed on March 21, 2016 (now U.S. Patent No. 9 / 498,247), entitled “ATHERECTOMY CATHETERS AND OCCLUSION CROSSING DEVICES,” both of which are incorporated by reference in their entireties. In some embodiments, applying further tension to the drive shaft (i.e., after exposing the nose cone) can result in compression of the curved portion, causing the curved portion to assume its final curved configuration. Having both nose cone deflection and a curved portion may allow for better tissue invagination, and therefore better or more efficient tissue cutting.

[0122] In embodiments where the nose cone does not deflect, the corresponding cutting window can be optimized to allow tissue to automatically indent into the cutting window. Furthermore, having the nose cone non-deflecting and relying solely on the flexure for tissue attachment can advantageously prevent the cutter from detaching from the nose cone during packaging. Furthermore, having the flexure alone (i.e., without nose cone actuation) can advantageously eliminate the need for additional mechanisms, such as pulling or pushing shafts, in concave-convex midsection procedures, thereby improving ease of use and enhancing image stability.

[0123] See also Figure 8A In some embodiments, the nose cone 805 can be flexible. That is, the elongated body can include one or more bends (as described herein), and the nose cone 805 can provide additional flexibility to allow the catheter to take a desired shape. For example, the nose cone 805 can include a repeating laser cut pattern covered in a laminate layer. Figure 8AAs shown, the pattern can include a series of spiral slits 850 extending around the circumference of the nose cone. In some embodiments, the laser cut pattern can be cut from stainless steel and can be laminated with a polymer such as Tecothane. Other flexible nose cone designs are described in U.S. Patent Application No. 14 / 776,749, filed on September 15, 2015 (now U.S. Patent Application Publication No. 2016-0008025-A1), entitled "TISSUE COLLECTION DEVICE FOR CATHETER," and International Patent Application No. PCT / US2017 / 035510, filed on June 1, 2017, entitled "CATHETER DEVICE WITH DETACHABLE DISTAL END," both of which are incorporated herein by reference in their entireties. The flexible nose cone can be used in addition to or as an alternative to any of the features of the elongated body curved portion described herein.

[0124] Any catheter device described herein may include an imaging system for collecting images of the outside of the catheter. In some embodiments, the imaging system includes a lateral optical coherence tomography (OTC) system coupled to the cutter and the drive shaft for collecting images of the outside of the catheter while the cutter and the drive shaft are rotating. Suitable imaging systems for examples are described in International Applications PCT / US2017 / 040431 and PCT / US2019 / 028415, each of which is incorporated herein by reference in its entirety.

[0125] Any catheter device described herein can include a locking assembly for locking the axial position of the drive shaft (inner shaft) relative to the outer shaft (catheter). The locking assembly can be used to, for example, maintain the distal end of the catheter assembly in a bent or straightened state, or to maintain the cutter in the outside or inside of the cutter window. In some cases, as described herein, the locking assembly allows for continuous adjustment of the curvature of the catheter. In some examples, the locking mechanism is located in the handle of the catheter device. Figures 15A to 15C An example of a slider lock 1501 in a handle 1500 of a catheter device is shown. Figure 15A15. In the embodiment of the present invention, the slider lock 1501 is located distally of the distally disposed slider button 1503. The inner drive shaft includes a hypotube 1513 and a drive key 1515. The drive key 1515 has a square cross-sectional shape that fits into a corresponding square opening at the distal end of the bracket 1520. This configuration forms a spline joint assembly 1521 that rotationally couples the drive key 1515 to the bracket 1520 but allows the drive key 1515 to translate axially relative to the bracket 1520. Thus, when the bracket 1520 is rotated by the drive motor, the inner drive shaft (drive key 1515 and hypotube 1513) also rotates, while the spline joint assembly 1521 allows the inner drive shaft (drive key 1515 and hypotube 1513) to translate axially relative to the bracket 1520 and the drive motor. The connector 1510 is disposed about the drive key 1515 and serves to translationally couple the slider button 1503 to the drive key 1515 while allowing the drive key 1515 to rotate independently of the slider button 1503. The connector 1510 includes a bearing 1511 (e.g., a ball bearing) that allows the drive key 1515 to rotate within the connector 1510. The slider button 1503 is rigidly coupled to the connector 1510. Thus, distal and proximal movement of the slider button 1503 results in corresponding distal and proximal movement of the inner drive shaft (drive key 1515 and hypotube 1513). In this manner, the ridge joint 1521 allows the slider button to translate axially relative to the drive shaft while allowing the drive shaft to rotate relative to the rest of the handle assembly, including the slider button.

[0126] The curved coil spring 1509 provides resistance against the slider button 1503 to keep the teeth 1505 of the slider button 1503 engaged with the corresponding teeth 1507 in the housing of the handle 1500, thereby locking the axial position of the drive shaft in place. To move the slider button 1503, the user presses the slider button 1503 radially inward to compress the coil spring 1509 and disengage the teeth 1505 of the slider button 1503 from the teeth 1507 in the housing of the handle 1500, as shown. Figure 15BAs shown in FIG. When slider button 1503 is depressed, the user can slide slider button 1503 proximally or distally. Slider button 1503 is disposed within an opening in the housing of handle 1500, wherein the opening is defined by a distal edge 1517 and a proximal edge 1519 that restrict distal and proximal movement of slider button 1503. Thus, when the user depresses slider button 1503, the user can translate slider button 1503 any distance between distal edge 1517 and proximal edge 1519. When the user releases pressure from slider button 1503, coil spring 1509 applies rearward pressure to slider button 1503, causing teeth 1505 of slider button 1503 to re-engage teeth 1507 of the housing of handle 1500, thereby relocking the position of the drive shaft relative to the non-translating portions of the catheter assembly, including the outer shaft. The user can select the degree of translation of the drive shaft within the outer shaft, as long as the translation of the slider button 1503 is between the distal edge 1517 and the proximal edge 1519. The distance between the distal edge 1517 and the proximal edge 1519 can be varied according to design requirements. In some examples, the distance between the distal edge 1517 and the proximal edge 1519 is in the range of about 0.5 inches to about 1.5 inches (e.g., 0.5 to 1.5 inches, 0.5 to 1.0 inches, 0.5 to 0.75 inches, or 0.75 to 1.5 inches, or 0.75 to 1.0 inches). The pitch of the teeth 1505 and 1507 is associated with the fineness of control the user has over the position of the locked drive shaft. In some examples, the pitch of teeth 1505 and 1507 is about 0.030 inches or less (e.g., 0.030 inches, 0.028 inches, 0.026 inches, 0.025 inches, 0.023 inches, 0.020 inches, 0.016 inches, or 0.015 inches or less). In some examples, the pitch of teeth 1505 and 1507 is in a range from about 0.020 inches to about 0.040 inches (e.g., 0.020 to 0.040 inches, 0.025 to 0.030 inches, or 0.025 to 0.040 inches).

[0127] Figure 15CThe slider lock 1501 is shown locked in the proximal-most position, with the slider button 1503 resting against the proximal edge 1519 of the housing of the handle 1500. As shown, the teeth 1505 of the slider button 1503 re-engage with the teeth 1507 within the housing of the handle 1500, thereby locking the axial position of the drive shaft (drive key 1515 and hypotube 1513) relative to the rest of the catheter system, including the outer shaft. Thus, the slider lock 1501 allows the user to move the drive shaft relative to the outer shaft as the drive shaft rotates, and allows the user to select the degree to which the drive shaft translates within the outer shaft and is locked relative to the outer shaft. In addition, the slider button 1503 allows a selected axial position of the drive shaft to be locked relative to the outer shaft. These features allow the user to select a range of curvatures for the flexible segment of the catheter and lock the flexible segment at the selected curvature. These features also allow the user to lock the cutter in an active mode (in which the cutter is extended through the cutter window) or a passive mode (in which the cutter is retracted into the cutter window). For example, with the slider button 1503 in the distal-most position (e.g., Figure 15A ) can be equivalent to the cutter being in the passive position and the flexible segment of the elongated body being in a straight or unbent position. Moving the slider button 1503 proximally a little from this distal-most position can cause the cutter to pop out of the cutter window. Further proximal movement of the slider button 1503 can cause the flexible segment to bend (e.g., an S-shaped bend), with increased proximal movement of the slider button 1503 causing the amount of bending to increase. Having the slider button 1503 in the proximal-most position (e.g., Figure 15C ) can be equated with the cutter being in the active position and the flexible segment of the elongated body being in the most curved position. Moving the slider button 1503 distally from this proximal-most position causes the curvature of the flexible segment to decrease, while increasing distal movement of the slider button 1503 causes the amount of curvature to decrease. Further distal movement of the slider button 1503 can cause the cutter to retract into the cutter window.

[0128] Figure 15C Also shown are portions of a saline flush system for the catheter. The handle 1500 may include a connector 1535 connected to the tube 1503 to provide fluid (e.g., saline) within the various portions of the catheter. Although not shown, the flexible tube 1530 may extend (at Figure 15C1535 extends upward in the catheter) to a connector (e.g., a Luer connector) that allows the user to directly connect a fluid source (e.g., a syringe or saline bag). The fluid can flow through the connector 1535 to the fluid housing 1537, which provides a fluid pathway between the drive shaft and the outer shaft. The fluid can be used for a variety of purposes. For example, the fluid can clear air from the catheter, provide lubrication for the rotational movement of the drive shaft, and replace blood with a light-transmitting fluid (e.g., saline) at the distal end of the catheter so that the imaging system can obtain images of the outside of the catheter within the blood vessel. In this example, the fluid housing 1537 includes a distal end 1532 having a first seal (e.g., an O-ring) and a proximal end 1534 having a second seal (e.g., an O-ring) for preventing fluid from entering other areas of the catheter handle assembly, such as the slider lock 1501 area of ​​the handle 1500.

[0129] It should be understood that any feature described herein with respect to one embodiment may be combined with or substituted for any feature described herein with respect to another embodiment.

[0130] In this article, when a feature or element is described as being "on" another feature or element, it can be directly located on other features or elements, or there can be intermediate features and / or elements. On the contrary, when a feature or element is described as being "directly located" on another feature or element, there are no intermediate features or elements. It should also be understood that when a feature or element is described as being "connected," "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to another feature or element, or there can be intermediate features or elements. On the contrary, when a feature or element is described as being "directly connected," "directly attached" or "directly coupled" to another feature or element, there are no intermediate features or elements. Although description or illustration is for one embodiment, the features and elements described or shown can be applied to other embodiments. It should also be understood by those skilled in the art that the structure or feature mentioned as being "adjacent" another feature can have a part that overlaps with the adjacent feature or is located below it.

[0131] The purpose of the terms used herein is only to describe specific embodiments and is not intended to limit the present invention. For example, unless the context clearly indicates otherwise, as used herein, the singular forms "a", "an" and "said" are intended to also include the plural forms. It should be further understood that the terms "include" and / or "comprising" used in this application indicate the presence of the features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts and / or combinations thereof. As used herein, the term "and / or" includes any or all combinations of one or more of the listed related items and can be abbreviated as " / ".

[0132] Spatially relative terms, such as "down," "below," "lower," "above," "higher," etc., may be used herein to describe the relative relationship of one element or feature shown in the drawings to another element or feature. It should be understood that, in addition to the orientation shown in the figures, spatially relative terms will cover different orientations of the device when in use or operation. For example, if the device in the drawings is flipped, the elements described as being "down" or "below" other elements or features will then be oriented as being "above" the other elements or features. Thus, the exemplary term "down" can cover both up and down orientations. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used herein should be interpreted accordingly. Similarly, unless expressly stated otherwise, the terms "up," "down," "vertical," "horizontal," etc., used herein are for illustrative purposes only.

[0133] Although "first" and "second" as used herein may be used to describe different features / elements (including steps), unless the context indicates otherwise, these features / elements should not be limited by these terms. These terms can be used to distinguish one feature / element from another feature / element. Therefore, without departing from the teachings of the present invention, the first feature / element discussed below may also be defined as the second feature / element, and similarly, the second feature / element discussed below may also be defined as the first feature / element.

[0134] Throughout the application and claims, unless the context requires otherwise, the word "comprise" and variations such as "include" and "comprising" refer to various components that can be employed in conjunction with a method or article (e.g., combinations and apparatus including apparatus and methods). For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0135] As used in the application and claims, including in the examples, unless expressly stated otherwise, all numbers may be read as beginning with the word "about" or "approximately", even if the term is not expressly shown. The word "about" or "approximately" may be used when describing a size and / or position to indicate that the value and / or position is within a reasonably expected range of values ​​and / or positions. For example, a numerical value may have a value of the stated value (or numerical range) + / - 0.1%, the stated value (or numerical range) + / - 1%, the stated value (or numerical range) + / - 2%, the stated value (or numerical range) + / - 5%, the stated value (or numerical range) + / - 10%, etc. Any numerical value listed herein is intended to include all subranges contained therein.

[0136] Although various illustrative embodiments have been described above, any number of changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, the order in which the various method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0137] The examples and descriptions herein show, by way of illustration and not limitation, specific embodiments in which the subject matter may be practiced. As previously mentioned, other embodiments may be used and derived therefrom, making structural and reasonable substitutions and changes without departing from the scope of this disclosure. If more than one invention or inventive concept is actually disclosed, such embodiments of the subject matter of the present invention may be referred to individually or collectively by the term "invention," which is merely for convenience and is not intended to actively limit the scope of this application to any single invention or inventive concept. Therefore, although specific embodiments are shown and described herein, any arrangement intended to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptive modifications or variations of the various embodiments. Upon reading the foregoing description, combinations of the foregoing embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art.

Claims

1. An atherectomy device, comprising: a catheter comprising a distal nose cone fixedly coupled to a flexible segment by a hub, the hub defining a fixed bend of the catheter, wherein the catheter comprises a cutter window distal to the fixed bend, wherein the flexible segment comprises a longitudinal ridge on one side of the flexible segment; and a cutter coupled to a rotatable drive shaft within the catheter, wherein proximal movement of the cutter and the rotatable drive shaft causes the cutter to slide along an edge of the bushing to tilt the cutter in a first direction and extend through the cutter window, wherein, when the cutter is extended through the cutter window, a force applied to the rotatable drive shaft in a proximal direction exerts compression on the flexible segment, the compression causing the flexible segment to bend away from the longitudinal spine and assume a curvature, and wherein distal movement of the cutter and the rotatable drive shaft causes the cutter to tilt in a second direction opposite the first direction and retract into the cutter window.

2. The atherectomy device according to claim 1, wherein: The extent of curvature of the flexible section can be adjusted based on the amount of force applied to the cutter and the rotatable drive shaft in the proximal direction.

3. The atherectomy device according to claim 1, wherein: The flexible section is configured to bend into an S-shape.

4. The atherectomy device according to claim 1, wherein: The flexible segment is configured to bend incrementally via proximal movement of the cutter and the rotatable drive shaft based on an amount of compression on the flexible segment.

5. The atherectomy device according to claim 1, wherein: The cutter includes a boss configured to slide along the edge of the bushing to radially move the cutter and extend the cutter through the cutter window.

6. The atherectomy device according to claim 1, wherein: The edge is inclined relative to an axis perpendicular to the longitudinal axis of the distal nose cone.

7. The atherectomy device according to claim 5, wherein: The edge is configured to tilt the cutter relative to the distal nose cone when the boss of the cutter slides along the edge.

8. The atherectomy device according to claim 1, wherein: The bushing includes an inner edge configured to slide along the angled surface of the cutter so that the cutter tilts in the second direction and will retract into the cutter window.

9. The atherectomy device according to claim 1, further comprising a handle located at the proximal end of the catheter, wherein The handle includes a lock configured to lock the flexible segment into a curved shape having a selected range of curvature.

10. The atherectomy device according to claim 9, wherein: The lock is configured to allow a user to select a locked position of the rotatable drive shaft relative to the catheter of 0.026 inches or less.

11. The atherectomy device according to claim 9, wherein: The lock includes a slider button configured to slide distally and proximally.

12. The atherectomy device according to claim 11, wherein: Sliding the slider button proximally increases the curvature of the flexible segment.

13. The atherectomy device according to claim 11, wherein: The slider button includes teeth configured to engage corresponding teeth in the handle to lock the axial position of the rotatable drive shaft relative to the catheter.

14. The atherectomy device according to claim 13, wherein: The handle includes a spring that applies pressure to the slider button to keep the teeth of the slider button engaged with corresponding teeth in the handle.

15. The atherectomy device according to claim 14, wherein: The slider button is configured to compress the spring when a user presses the slider button, thereby disengaging the teeth of the slider button from corresponding teeth in the handle.

16. The atherectomy device according to claim 11, wherein: The handle includes a ridge joint that allows the slider button to translate axially relative to the rotatable drive shaft while allowing the rotatable drive shaft to rotate relative to the slider button.

17. The atherectomy device according to claim 1, wherein: The flexible segment includes a first portion axially adjacent to a second portion, the first portion having a first longitudinal ridge and the second portion having a second longitudinal ridge, wherein the first longitudinal ridge and the second longitudinal ridge are located on opposite sides of the flexible segment, and wherein a force applied to the rotatable drive shaft in the proximal direction causes the first portion to bend laterally away from the first longitudinal ridge and the second portion to bend laterally away from the second longitudinal ridge.

18. An atherectomy device, comprising: a catheter comprising a nose cone fixedly coupled to the elongated body at a fixed bend of the catheter, the fixed bend being defined by a bushing, wherein the catheter includes a cutter window on a convex side of the fixed bend; and A cutter coupled to a rotatable drive shaft within a catheter, wherein proximal movement of the cutter and the rotatable drive shaft causes the cutter to slide along an edge of the hub to tilt the cutter in a first direction and extend through the cutter window, and wherein distal movement of the cutter and the rotatable drive shaft causes the cutter to tilt in a second direction opposite the first direction and retract into the catheter.

19. The atherectomy device according to claim 18, wherein: The cutter window is disposed distally along the catheter relative to the fixed bend.

20. The atherectomy device according to claim 18, wherein: The cutter is configured to move radially when extending through the cutter window.

21. The atherectomy device according to claim 18, wherein: When the cutter extends through the cutter window, at least a portion of the cutting edge of the cutter corresponds to a most protruding point along the convex side of the fixed curve.

22. The atherectomy device according to claim 18, wherein: The cutter is configured to transition between an active mode and a passive mode, wherein the cutting edge of the cutter extends through the cutter window in the active mode, and wherein the cutting edge of the cutter is retracted within the catheter in the passive mode.

23. The atherectomy device according to claim 22, wherein: In the active mode, the cutter is substantially parallel to the nose cone, and in the passive mode, the cutter is substantially parallel to the elongated body.

24. The atherectomy device according to claim 22, wherein: The cutting edge of the cutter is retained in the passive mode by a pawl that requires a threshold translational force to be applied to the rotatable drive shaft to release the pawl and transition the cutter from the passive mode.

25. The atherectomy device according to claim 22, wherein: The cutting The actuator is rotatable in the active mode and in the passive mode.

26. The atherectomy device according to claim 22, wherein: The cutter includes an imaging sensor configured to collect images of the exterior of the catheter when the cutter is in the active mode and the passive mode.

27. The atherectomy device according to claim 26, wherein: The catheter includes one or more openings configured to align with the imaging sensor and to serve as position markers for the imaging sensor when the cutter is in the active mode.

28. The atherectomy device according to claim 18, wherein: The angle of the fixed bending portion is in the range of 1 degree to 30 degrees.

29. The atherectomy device according to claim 18, wherein When the cutter extends through the cutter window, the central axis of the cutter is angled relative to the central axis of the nose cone in a range of 1 degree to 30 degrees.

30. The atherectomy device according to claim 18, wherein The cutter includes a boss configured to slide along the edge of the hub to radially move the cutter and extend the cutter through the cutter window as the cutter and the rotatable drive shaft move proximally.

31. The atherectomy device according to claim 18, wherein: The lumen of the catheter defines a first channel and a second channel, wherein the edge is configured to urge the cutter from the first channel to the second channel upon proximal movement of the cutter and the rotatable drive shaft.

32. The atherectomy device of claim 18, wherein: The cutter is configured to move distally to pack tissue into the nose cone.

33. The atherectomy device according to claim 18, wherein: The cutter is configured to transition between being parallel to the nose cone and being parallel to the elongated body.

34. The atherectomy device of claim 18, wherein: The elongated body includes a flexible section disposed proximally relative to the fixed curve, wherein a range of curvature of the flexible section is adjustable based on a range of proximal motion of the cutter and the rotatable drive shaft relative to the catheter.

35. The atherectomy device according to claim 34, wherein: The flexible segment is configured to assume an S-shaped bend as the cutter and the rotatable drive shaft move proximally within the catheter.

36. The atherectomy device of claim 34, further comprising a handle located at the proximal end of the catheter, wherein The handle includes a lock configured to lock the flexible segment into a curved shape.

37. The atherectomy device according to claim 36, wherein: The lock is configured to allow a user to select a locked position of the rotatable drive shaft relative to the catheter of 0.026 inches or less.

38. The atherectomy device according to claim 36, wherein: The lock includes a slider button configured to slide distally and proximally.

39. The atherectomy device according to claim 38, wherein Sliding the slider button proximally increases the curvature of the flexible segment.

40. The atherectomy device of claim 38, wherein: The handle includes a ridge joint that allows the slider button to translate axially relative to the rotatable drive shaft while allowing the rotatable drive shaft to rotate relative to the slider button.

41. The atherectomy device of claim 34, wherein: The flexible segment includes a first portion axially adjacent to a second portion, the first portion having a first longitudinal ridge and the second portion having a second longitudinal ridge, wherein the first longitudinal ridge and the second longitudinal ridge are located on opposite sides of the flexible segment, and wherein a force applied to the rotatable drive shaft in the proximal direction causes the first portion to bend laterally away from the first longitudinal ridge and the second portion to bend laterally away from the second longitudinal ridge.

42. The atherectomy device of claim 18, wherein: The elongated body includes a flexible segment disposed proximally relative to the fixed bend, the flexible segment including a first portion axially adjacent a second portion, the first portion having a first longitudinal ridge and the second portion having a second longitudinal ridge, wherein the first longitudinal ridge and the second longitudinal ridge are located on opposite sides of the flexible segment.

43. The atherectomy device according to claim 42, wherein: Further proximal movement of the rotatable drive shaft causes the flexible segment to compress, causing the first portion to bend laterally away from the first longitudinal spine, and the second portion to bend laterally away from the second longitudinal spine, causing the flexible segment to assume an s-shape.

Images