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US 12,575,833 B2Granted
Balloon catheter for transcarotid procedures
AssigneeBoston Scientific Scimed, Inc.
InventorsNatasha Johnston, Stewart M. Kume, Erica J. Rogers
Life of this patent
Estimating the term…
Abstract
Devices and methods establish and facilitate retrograde or reverse flow blood circulation in the region of the carotid artery bifurcation in order to limit or prevent the release of emboli into the cerebral vasculature. Devices and methods are configured for procedures performed through a transcarotid approach for performing transcarotid procedures, including carotid angioplasty, stent deployment, and post stent deployment procedures.
Claims28
A transcarotid access and treatment system, comprising:
- an arterial access sheath including a sheath defining an internal lumen, the sheath sized and shaped to be introduced into an opening in a common carotid artery of a patient, the arterial access sheath including a proximal sheath end and a distal sheath end, the distal sheath end being configured for insertion into the common carotid artery and the proximal sheath end comprising a single visual alignment marker positioned to be maintained outside of the common carotid artery for viewing outside the patient without fluoroscopic imaging and positioned to be within a field of view of a user during use, wherein the single visual alignment marker is positioned a first distance from the distal sheath end;
- a balloon catheter, comprising
- a catheter shaft extending between a proximal end and a distal end of the balloon catheter;
- a balloon positioned adjacent the distal end of the balloon catheter and configured to transition between a deflated state and an inflated state, the balloon being sized to travel through the internal lumen of the sheath and into the common carotid artery;
- a flexible tip extending a second distance from a distal balloon end of the balloon;
- and
- a single visual indicator positioned along the catheter shaft, the single visual indicator configured for naked-eye visualization without fluoroscopic imaging and positioned a third distance from the distal end of the balloon catheter, the first distance and the third distance being the same distance and within a range of approximately 250 millimeters (mm) and approximately 350 mm, wherein alignment of the single visual indicator with the single visual alignment marker of the arterial access sheath outside the patient indicates alignment of a distal end of the flexible tip with a distal lumen end of the internal lumen of the arterial access sheath such that alignment of the single visual indicator and the single visual alignment marker can be directly viewed by the user to allow alignment of the single visual indicator with the single visual alignment marker to be achieved and viewed by the user without the use of fluoroscopy, and
- wherein the third distance allows the single visual indicator to be viewed, by direct visual observation without the use of fluoroscopy, by a user while the distal sheath end of the arterial access sheath is positioned in the common carotid artery and while the distal end of the balloon catheter is aligned with the distal lumen end of the internal lumen of the arterial access sheath.
5 more elements
A method of a transcarotid access and treatment system, comprising:
- inserting a distal end of a balloon catheter into an internal lumen of an arterial access sheath that is introduced into an opening in a common carotid artery of a patient such that a distal lumen end of the internal lumen of the arterial access sheath is positioned in the common carotid artery, the arterial access sheath comprising a proximal sheath end including a single visual alignment marker positioned to be maintained outside of the common carotid artery for viewing outside the patient without fluoroscopic imaging and positioned to be within a field of view of a user during use, the single visual alignment marker positioned a first distance from the distal sheath end, the balloon catheter including a balloon positioned adjacent the distal end of the balloon catheter and configured to transition between a deflated state and an inflated state, the balloon catheter including a flexible tip extending a second distance from a distal balloon end of the balloon;
- aligning, without the use of fluoroscopy, through direct visual observation, a single visual indicator positioned along a catheter shaft of the balloon catheter with the single visual alignment marker of the arterial access sheath outside the patient thereby aligning the distal end of the balloon catheter with the distal lumen end of the internal lumen of the arterial access sheath, the single visual indicator positioned a third distance from the distal end of the balloon catheter, the first distance and the third distance being the same distance and within a range of approximately 250 millimeters (mm) and approximately 350 mm, wherein alignment of the single visual indicator and the single visual alignment marker can be directly viewed by the user to allow alignment of the single visual indicator with the single visual alignment marker to be achieved and viewed by the user without the use of fluoroscopy, wherein the third distance allows the single visual indicator to be viewed, by direct visual observation without the use of fluoroscopy, by a user while the distal sheath end of the arterial access sheath is positioned in the common carotid artery and while the distal end of the balloon catheter is aligned with the distal lumen end of the internal lumen of the arterial access sheath;
- and
- advancing the balloon to a treatment site for performing a part of a carotid angioplasty procedure.
1 more element
A balloon catheter, comprising
- a catheter shaft extending between a proximal end and a distal end of the balloon catheter;
- a balloon positioned adjacent the distal end of the balloon catheter and configured to transition between a deflated state and an inflated state;
- a flexible tip extending from a distal balloon end of the balloon;
- and
- a single visual indicator positioned along the catheter shaft, the single visual indicator configured for naked-eye visualization without fluoroscopic imaging and positioned a first distance from the distal end of the balloon catheter, the first distance being within a range of approximately 250 millimeters (mm) and approximately 350 mm, wherein alignment of the single visual indicator with a single visual alignment marker positioned along a proximal sheath end of an arterial access sheath and a third distance from a distal lumen end of the internal lumen indicates alignment of the distal end of the balloon catheter with a distal lumen end of the internal lumen of the arterial access sheath such that alignment of the single visual indicator and the single visual alignment marker can be directly viewed by the user to allow alignment of the single visual indicator with the single visual alignment marker to be achieved and viewed by the user without the use of fluoroscopy, the single visual alignment marker of the arterial access sheath being positioned the first distance from the distal lumen and configured to be maintained outside of the common carotid artery of a patient for viewing outside the patient without fluoroscopic imaging and positioned to be within a field of view of a user during use, and wherein the third distance allows the single visual indicator to be viewed, by direct visual observation without the use of fluoroscopy, by a user while a distal sheath end of the arterial access sheath is positioned in the common carotid artery and while the distal end of the balloon catheter is aligned with the distal lumen end of the internal lumen of the arterial access sheath.
2 more elements
Dependencies are inferred from the claim text.