Avinger, Inc.

Other

High Point Equipment LLC

Charles W McNall

Michael Zung

John B Simpson

Maegan K Spencer

John F Black

Priyanshu Gupta

Nicholas J Spinelli

Michael H Rosenthal

Himanshu N Patel

Peter H Smith

Dennis W Jackson

Christopher B White

Evangeline Lumabas

Manish Kankaria

Brian Y Tachibana

Douglas Joseph Scott Bourne

Brian Chiu

Theodore W Ketai

Kin F Chan

Benjamin Ngo

Kent C B Stalker

Stephen Charles Davies

Mark West Askew

Wendy Ngo Lam

Douglas Anjewierden

Richard Roy Newhauser, Jr

Anthony J Fernandez

Eduardo U Sucgang

Myra L Fabro

Christina Van

A catheter device for crossing occlusions includes an elongate body, a central lumen extending within the elongate body from the proximal end to the distal end, a rotatable tip at the distal end of the elongate body, and an OCT imaging sensor. The rotatable tip is configured to rotate relative to the elongate body. The OCT imaging sensor includes an optical fiber coupled with the rotatable tip and configured to rotate therewith. A distal end of the elongate body includes one or more markers configured to occlude the OCT imaging sensor as it rotates. A fixed jog in the elongate body proximal to the distal end of the catheter positions the distal end of the catheter at an angle relative to the region of the catheter proximal to the fixed jog and is aligned with the one or more markers on the elongate body.

Occlusion-crossing devices, imaging, and atherectomy devices

Systems and methods of optical coherence tomography. The systems may include a source of optical radiation, an elongate catheter body, an optical fiber, a handle, a detector and a processor. The optical fiber may extend from a proximal end to a distal end of the elongate catheter body, and be fixed to the distal end of the elongate catheter body. The optical fiber may provide a common path for radiation reflected from a reference and a target. The handle may be attached to the proximal end of the elongate catheter body and be configured to allow rotation of the elongate catheter body and the optical fiber relative to the handle about a longitudinal axis. The detector may be configured to receive the radiation reflected from the reference and the target. The processor may be configured to generate an image of the target based upon the radiation received by the detector.

Optical coherence tomography for biological imaging

A drive assembly for driving an imaging catheter has a rotatable fiber and a rotatable drive shaft. The drive assembly includes a fiber optic rotating junction and a motor configured to rotate the rotatable portion of the fiber optic rotating junction. In some embodiments, the drive assembly includes a sensor configured to detect a rotational position of the fiber optic rotating junction and a processor configured to obtain the detected rotational position and stop the motor only when the fiber optic rotating junction is in a predetermined rotational position. In some embodiments, the motor includes a hollow shaft through which at least a portion of the fiber optic rotating junction extends.

Atherectomy catheter drive assemblies

Methods of performing an atherectomy using an atherectomy catheter. The atherectomy catheter may include a catheter body, a driveshaft, and a distal tip assembly. The driveshaft may include an annular cutting ring with a distal cutting edge. A long axis of the annular cutting ring can be configured to be parallel to a longitudinal axis of the distal tip assembly when the distal tip assembly is deflected with respect to the catheter body. The methods may include advancing the atherectomy catheter within a vessel lumen; axially moving the driveshaft relative to the catheter body to deflect the distal tip assembly with respect to the catheter body and radially extend the distal cutting edge of the annular cutting ring relative to the distal end of the catheter body; driving the distal cutting edge against a wall of the vessel lumen to remove tissue.

Methods of using atherectomy catheter with deflectable distal tip

A system for imaging a body lumen includes a controller and a display. The controller is configured to connect to a proximal end of a catheter having an optical fiber extending along the length of an elongate catheter body. The controller is further configured to rotate a distal end of the optical fiber from a location near a proximal end of the elongate catheter body, acquire optical coherence tomography (OCT) images using the optical fiber as the distal end of the optical fiber rotates, and determine a rotational lag of the distal end of the optical fiber. The display is configured to display one or more OCT images corrected for the rotational lag.

Catheter-based off-axis optical coherence tomography imaging system

An imaging device includes a hollow flexible shaft having a central longitudinal axis and an imaging window therein. An optical fiber extends within the hollow flexible shaft substantially along the central axis. A distal tip of the optical fiber is attached to the hollow flexible shaft and aligned with the imaging window so as to transfer an optical coherence tomography signal through the imaging window. A handle is attached to the hollow flexible shaft configured rotate the hollow flexible shaft at speeds of greater than 1,000 rpm.

Chronic total occlusion crossing devices with imaging

Described herein are catheters for use with Optical Coherence Tomography (OCT) that include an optical fiber core having a first refractive index and an interface medium having a second refractive index, where the first and second refractive indexes are mismatched such that receiving electronics configured to receive optical radiation reflected from the reference interface and the target operate in a total noise range that is within 5 dB of the shot noise limit. These OCT catheters may include a silicon die mirror having a reflective coating that is embedded in the interface medium. The optical fiber can be fixed at just the distal end of the catheter, and may be managed within a handle that is attached to the proximal end of the catheter body, and is configured to allow rotation of the both catheter body and the optical fiber relative to the handle.

Described herein are atherectomy catheters, systems and methods that include a distal tip region that may be moved laterally so that its long axis is parallel with the long axis of the main catheter body axis. Displacing the distal tip region laterally out of the main catheter body axis exposes an annular blade and opens a passageway for cut tissue to enter a storage region within the catheter. The annular blade may be internally coupled to a drive shaft that rotates the blade, and thus the exposed blade edge may have the same crossing profile (OD) as the rest of the distal end region of the catheter. Also described herein are gear-driven atherectomy devices that may use a cable drive shaft to actuate the annular blade. Both push-to-cut and pull-to-cut variations are described, as are methods for cutting tissue and systems including these atherectomy catheters.

Atherectomy catheter with laterally-displaceable tip

An atherectomy catheter includes an elongate flexible catheter body, an elongate deflectable distal tip coupled to the catheter body at a hinge point, a rotatable cutter near the distal end of the catheter body, and a drive shaft extending within the catheter body and configured to rotate the cutter. The atherectomy catheter further includes an optical fiber extending through the drive shaft substantially on-axis with the catheter body and attached to the cutter. The optical fiber is configured to rotate with the drive shaft. The atherectomy catheter further includes a wedge configured to deflect the distal tip away from the catheter body at the hinge point upon axial movement of the drive shaft.

Atherectomy catheters with imaging

Described herein are atherectomy catheters, systems and methods that include longitudinally displaceable drive shafts that drive actuation of one or more cutters at the distal end of the catheter. The catheters described herein may include one or more imaging sensors for imaging before, during or after cutting tissue. In some variations the imaging sensor may be rotated around the perimeter of the catheter independently of the rotation of the cutter. Also describe herein are imaging catheters that may be used without cutters.

Atherectomy catheter

An atherectomy catheter includes an elongate flexible catheter body, a cutter near the distal end of the catheter body, a drive shaft connected to the cutter and extending within the catheter body, an imaging element near the distal end of the catheter body.

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Cottonwood Heights, UT, United States of America

Charles W McNall