# US 11,998,311 B2 · Guidewire positioning catheter > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,311 B2 - Document ID: US11998311B2 - Status: Granted - Kind: B2 - Application number: 17/443,398 - Filed: 2021-07-26 - Published: 2021-11-11 - Granted: 2024-06-04 - Earliest claimed: 2009-04-28 - Assignees: Avinger, Inc. - Applicants: Avinger, Inc. - Inventors: Himanshu N. Patel; John B. Simpson - Web page: https://patentgrep.com/patent/US11998311B2 ## CPC - A61B 5/066: {Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging} - A61B 17/320758: {with a rotating cutting instrument, e.g. motor driven (A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002)} - A61M 25/01: Introducing, guiding, advancing, emplacing or holding catheters (A61M25/10 takes precedence) - A61M 25/0138: {having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils} - A61B 2017/003: {Steerable} - A61B 2017/00309: {Cut-outs or slits} - A61B 2017/22038: {with a guide wire} - A61B 2017/320775: {Morcellators, impeller or propeller like means} - A61M 25/0147: {with movable mechanical means, e.g. pull wires} - A61M 25/0155: {with hydraulic or pneumatic means, e.g. balloons or inflatable compartments} - A61M 25/0172: {Exchanging a guidewire while keeping the catheter in place} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract A catheter for positioning a guidewire across an occluded portion of a vessel includes an elongate catheter body, an integrated rotatable distal tip, a proximal handle region, and a catheter lumen extending through the elongate catheter body. The elongate body has a distal region configured to be bent to a set angle. The integrated rotatable distal tip includes one or more channeled flutes extending around the distal tip that are configured to be rotated in a first direction to dissect tissue and a second direction for bluntly contacting tissue. A proximal handle region includes a control for rotating the distal tip in either the first or second directions. The catheter lumen is configured to pass a guidewire. ## Claims ### Claim 1 A catheter device for positioning a guidewire across an occluded portion of a vessel, the catheter device comprising: a catheter body having a central lumen and a steerable distal region, the steerable distal region configured to bend laterally toward a predetermined side of the catheter body, wherein a distal end of the catheter body includes spiral shaped wedge members; and a driveshaft extending within the central lumen and configured to rotate with respect to of the catheter body, the driveshaft coupled to and configured to rotate a distal tip having one or more cutting edges, wherein the driveshaft is configured to move longitudinally relative to the catheter body to extend the distal tip distally out of a central opening of the distal end of the catheter body and retract the distal tip proximally within the catheter body, wherein the one or more cutting edges are arranged in a spiral that is radially aligned with the spiral shaped wedge members of the distal end of the catheter body when the one or more cutting edges are extended out of the distal end of the catheter body, wherein the catheter device is configured to lock at least a portion of the distal tip in an extended position out of the central opening of the distal end of the catheter body, wherein the steerable distal region of the catheter body is configured to bend laterally toward the predetermined side of the catheter body upon application of a longitudinal pushing force on the driveshaft. ### Claim 2 (depends on 1) The catheter device of claim 1, further comprising a handle configured to control lateral bending of the catheter body, and extension and retraction of the distal tip. ### Claim 3 (depends on 2) The catheter device of claim 2, wherein the handle further comprises an indicator configured to indicate an extent to which the distal tip is extended. ### Claim 4 (depends on 2) The catheter device of claim 2, wherein the handle is further configured to control rotation of the driveshaft and the distal tip. ### Claim 5 (depends on 4) The catheter device of claim 4, wherein the handle comprises: a first control configured to control rotation of the driveshaft and the distal tip; and a second control configured to control lateral bending of the catheter body, and extension and retraction of the distal tip with respect to the catheter body, by controlling longitudinal movement of the driveshaft. ### Claim 6 (depends on 5) The catheter device of claim 5, wherein the first control includes a slider component, and wherein the second control includes a rotator component. ### Claim 7 (depends on 6) The catheter device of claim 6, wherein the slider component is configured to slide distally to extend the distal tip distally out of the catheter body, and slide further distally to bend the steerable distal region. ### Claim 8 (depends on 2) The catheter device of claim 2, wherein the handle further comprises a lock configured to lock the catheter body in a bent configuration or a straight configuration. ### Claim 9 (depends on 8) The catheter device of claim 8, wherein the handle further comprises a slider component configured to slide longitudinally, wherein the lock is configured to restrict movement of the slider component. ### Claim 10 (depends on 2) The catheter device of claim 2, wherein the handle further comprises a luer connecter that provides entry to a lumen of the catheter device. ### Claim 11 (depends on 1) The catheter device of claim 1, wherein rotation of the driveshaft is driven by a motor. ### Claim 12 (depends on 1) The catheter device of claim 1, wherein the driveshaft and the distal tip are configured to rotate in either a clockwise direction or a counterclockwise direction. ### Claim 13 (depends on 1) The catheter device of claim 1, wherein the steerable distal region of the catheter body includes a scaffold having a narrow solid band that extends longitudinally along the scaffold, wherein the steerable distal region is configured to bend toward the narrow solid band. ### Claim 14 (depends on 1) The catheter device of claim 1, wherein the device includes a lock that is configured to lock at least a portion of the one or more cutting edges in the extended position. ### Claim 15 (depends on 1) The catheter device of claim 1, wherein the one or more cutting edges are configured to extend from the distal end of the catheter body by a predetermined maximum extension when locked in the extended position. ### Claim 16 A method of positioning a guidewire across an occlusion within a vessel, the method comprising: advancing a catheter device through the vessel and toward the occlusion, the catheter device comprising: a catheter body having a lumen and steerable distal region, wherein a distal end of the catheter body includes spiral shaped wedge members; and a driveshaft extending within the lumen, the driveshaft coupled to a distal tip having one or more cutting edges; crossing the occlusion by: extending the distal tip distally from within the catheter body to expose the one or more cutting edges, wherein at least a portion of the distal tip is locked in an extended position out of a central opening of the distal end of the catheter body, and wherein the one or more cutting edges are arranged in a spiral that is radially aligned with the spiral shaped wedge members of the distal end of the catheter body when the one or more cutting edges are extended out of the distal end of the catheter body; rotating the driveshaft to cause the distal tip to rotate and cut the occlusion with the one or more cutting edges of the distal tip; and applying a longitudinal pushing force on the driveshaft to cause the steerable distal region of the catheter body to bend laterally toward a predetermined side of the steerable distal region and to steer the rotating distal tip within the vessel; and positioning the guidewire through the catheter body and across the occlusion. ### Claim 17 (depends on 16) The method of claim 16, wherein rotating the distal tip comprises rotating the distal tip in a clockwise direction and a counterclockwise direction. ### Claim 18 (depends on 16) The method of claim 16, wherein the catheter device includes a handle having a first control and a second control, wherein rotating the distal tip comprises manipulating the first control, wherein extending the distal tip distally comprises manipulating the second control. ### Claim 19 (depends on 18) The method of claim 18, wherein the second control controls longitudinal movement of the driveshaft. ### Claim 20 (depends on 16) The method of claim 16, further comprising delivering fluid to a desired area within the vessel through the lumen of the catheter device. ### Claim 21 (depends on 16) The method of claim 16, further comprising locking the steerable distal region in a bent configuration. ### Claim 22 (depends on 21) The method of claim 21, wherein locking the steerable distal region in the bent configuration comprises restricting longitudinal movement of the driveshaft within the catheter body.