US-20260123953-A1 - Atherectomy-Angioplasty Devices, Systems, and Methods

US20260123953A1US 20260123953 A1US20260123953 A1US 20260123953A1US-20260123953-A1

Abstract

Atherectomy-angioplasty devices, systems, and methods reduce the device costs, procedure times, and risks associated with clinician error and patient trauma that accompany separate atherectomy and angioplasty devices. An example atherectomy-angioplasty device includes a tubular body, an elongate rotor, a plaque-debulking element, and an elongate balloon. The tubular body includes a rotor lumen and an inflation lumen. The elongate rotor is disposed in the rotor lumen. The plaque-debulking element is configured to debulk atherosclerotic or restenotic plaques in a blood-vessel lumen of a patient. To do so, the plaque-debulking element is actuated by the elongate rotor when the elongate rotor is rotated around its longitudinal axis in the rotor lumen. The elongate balloon is over a distal portion of the tubular body. The elongate balloon is fluidly connected to the inflation lumen for inflating or deflating the elongate balloon, as desired, for preventing dispersion of atherosclerotic debris, angioplasty, or both.

Inventors

Danielle Mariah Pompa
Bryon Ray Densley
Hannah Gracie O'neill
Carolyn Benner
Sebastian Zickwolf
Lukas Oettinger

Assignees

STRAUB MEDICAL AG

Dates

Publication Date: 20260507
Application Date: 20241105

Claims (20)

1 . An atherectomy-angioplasty device, comprising: a tubular body including a rotor lumen and an inflation lumen; an elongate rotor disposed in the rotor lumen; a plaque-debulking element actuated by the elongate rotor when the elongate rotor is rotated around its longitudinal axis in the rotor lumen, the plaque-debulking element configured to debulk atherosclerotic or restenotic plaques in a blood-vessel lumen of a patient; and an elongate balloon over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon as desired, optionally, for angioplasty therewith.
2 . The atherectomy-angioplasty device of claim 1 , wherein the elongate balloon is compactly folded in a ready-to-deploy state of the atherectomy-angioplasty device.
3 . The atherectomy-angioplasty device of claim 2 , further comprising an expandable stent over the elongate balloon in the ready-to-deploy state of the atherectomy-angioplasty device.
4 . The atherectomy-angioplasty device of claim 2 , further comprising a retractable sheath over the elongate balloon in the ready-to-deploy state of the atherectomy-angioplasty device.
5 . The atherectomy-angioplasty device of claim 4 , wherein the elongate balloon includes a coating of an antiproliferative drug on an external surface of the elongate balloon, the retractable sheath protecting the coating prior to retracting the retractable sheath and inflating the elongate balloon for angioplasty therewith.
6 . The atherectomy-angioplasty device of claim 1 , wherein the elongate rotor approximates a shaftless screw auger that creates a vacuum for aspirating atherosclerotic debris into the rotor lumen when the shaftless screw auger is rotated around its longitudinal axis in the rotor lumen.
7 . The atherectomy-angioplasty device of claim 6 , wherein the plaque-debulking element is a rotatable cutting tip coupled to the tubular body, the cutting tip coupled to the shaftless screw auger such that the cutting tip rotates around its longitudinal axis for cutting atherosclerotic or restenotic plaques away from the blood-vessel lumen of the patient when the shaftless screw auger is rotated around its longitudinal axis in the rotor lumen.
8 . The atherectomy-angioplasty device of claim 7 , wherein the cutting tip includes at least one side aperture in fluid communication with the rotor lumen, the side aperture allowing the atherosclerotic debris to be aspirated into the rotor lumen for extracorporeal collection of the atherosclerotic debris.
9 . The atherectomy-angioplasty device of claim 6 , wherein an absence of a shaft in the shaftless screw auger provides a guidewire lumen for a guidewire.
10 . The atherectomy-angioplasty device of claim 1 , wherein the elongate rotor approximates a coiled-spring cable.
11 . The atherectomy-angioplasty device of claim 10 , wherein the plaque-debulking element is an abrasive mass in a distal portion of the coiled-spring cable that orbits around a longitudinal axis of the coiled-spring cable for abrading atherosclerotic or restenotic plaques away from the blood-vessel lumen of the patient when the coiled-spring cable is rotated around its longitudinal axis in the rotor lumen.
12 . The atherectomy-angioplasty device of claim 11 , wherein the abrasive mass includes an abrasive band around a bump in cable diameter of the coiled-spring cable.
13 . The atherectomy-angioplasty device of claim 10 , wherein an axial channel through the coiled-spring cable provides a guidewire lumen for a guidewire.
14 . An atherectomy-angioplasty system, comprising: atherectomy-angioplasty device including: a tubular body including a rotor lumen and an inflation lumen; an elongate rotor disposed in the rotor lumen; a plaque-debulking element actuated by the elongate rotor when the elongate rotor is rotated around its longitudinal axis in the rotor lumen, the plaque-debulking element configured to debulk atherosclerotic or restenotic plaques in a blood-vessel lumen of a patient; and an elongate balloon over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon as desired, optionally, for angioplasty therewith; and a drive unit operably connected to the atherectomy-angioplasty device, the drive unit including a drive mechanism configured to rotate the elongate rotor around its longitudinal axis in the rotor lumen of the atherectomy-angioplasty device.
15 . The atherectomy-angioplasty system of claim 14 , the atherectomy-angioplasty device further comprising an expandable stent over a compactly folded elongate balloon in a ready-to-deploy state of the atherectomy-angioplasty device.
16 . The atherectomy-angioplasty system of claim 14 , wherein the elongate balloon includes a coating of an antiproliferative drug on an external surface of the elongate balloon.
17 . The atherectomy-angioplasty system of claim 14 , further comprising a collection unit fluidly connected to the rotor lumen of the atherectomy-angioplasty device, the collection unit configured for collecting atherosclerotic debris aspirated into the rotor lumen.
18 . The atherectomy-angioplasty system of claim 14 , further comprising: a guidewire configured for advancing the atherectomy-angioplasty device over the guidewire such that the plaque-debulking element is adjacent the atherosclerotic or restenotic plaques in the blood-vessel lumen of the patient; and a fluid-delivery device configured for inflating or deflating the elongate balloon via the inflation lumen with a fluid.
19 . A method of an atherectomy-angioplasty system, comprising: obtaining an atherectomy-angioplasty device, the atherectomy-angioplasty device including: a tubular body including a rotor lumen and an inflation lumen; an elongate rotor disposed in the rotor lumen; a plaque-debulking element actuated by the elongate rotor when the elongate rotor is rotated around its longitudinal axis in the rotor lumen; and an elongate balloon over a distal portion of the tubular body, the elongate balloon fluidly connected to the inflation lumen for inflating or deflating the elongate balloon; advancing the plaque-debulking element to a treatment area within a blood-vessel lumen of a patient; driving a drive unit operably connected to the atherectomy-angioplasty device, the drive unit including a drive mechanism configured to rotate the elongate rotor around its longitudinal axis in the rotor lumen of the atherectomy-angioplasty device to debulk an atherosclerotic or restenotic plaque in the treatment area; and inflating the elongate balloon via the inflation lumen with fluid from a fluid-delivery device such that the elongate balloon is at least in contact with a blood-vessel wall in the treatment area.
20 . The method of claim 19 , wherein inflating the elongate balloon is performed before driving the drive unit to debulk the atherosclerotic or restenotic plaque in the blood-vessel lumen of the patient, the elongate balloon blocking blood flow by way of its contact with the blood-vessel wall and, thereby, preventing dispersion of atherosclerotic debris from the treatment area.

Description

BACKGROUND Peripheral artery disease (“PAD”) is a condition of reduced or blocked blood flow through the peripheral arteries that currently affects about 202 million people worldwide. In PAD, the peripheral arteries are typically narrowed or blocked as a result of atherosclerosis or the atherosclerotic plaques thereof, which plaques include fat, cholesterol, calcium, and other substances found in the blood. Notably, such plaques can cause the peripheral arteries to stiffen over time, which makes it harder for the heart to pump blood therethrough—even if there is sufficient blood flow through the peripheral arteries. Atherectomy is indicated for people who have severe atherosclerosis with substantially hardened atherosclerotic plaques. Atherectomy is also indicated for people who have previously had procedures such as angioplasty but have since developed restenotic plaques that reduce or block blood flow. In any case, atherectomy restores patency in people's peripheral arteries by debulking such plaques with any of several atherectomy devices specifically designed therefor. Angioplasty with optional stent placement often follows atherectomy; however, angioplasty is performed with any of several angioplasty devices specifically designed therefor. Thus, while patients often need both atherectomy and angioplasty to restore patency in their peripheral arteries, two different devices are required therefor. This increases device costs, procedure times, risks associated with at least clinician error and patient trauma, or some combination thereof. Disclosed herein are atherectomy-angioplasty devices, systems, and methods thereof that reduce the foregoing device costs, procedure times, and risks associated with clinician error and patient trauma that accompany separate atherectomy and angioplasty devices. SUMMARY Disclosed herein is an atherectomy-angioplasty device including, in some embodiments, a tubular body, an elongate rotor, a plaque-debulking element, and an elongate balloon. The tubular body includes a rotor lumen and an inflation lumen. The elongate rotor is disposed in the rotor lumen. The plaque-debulking element is configured to debulk atherosclerotic or restenotic plaques in a blood-vessel lumen of a patient. To do so, the plaque-debulking element is actuated by the elongate rotor when the elongate rotor is rotated around its longitudinal axis in the rotor lumen. The elongate balloon is over a distal portion of the tubular body. The elongate balloon is fluidly connected to the inflation lumen for inflating or deflating the elongate balloon as desired, optionally, for angioplasty therewith. In some embodiments, the elongate balloon is compactly folded in a ready-to-deploy state of the atherectomy-angioplasty device. In some embodiments, the atherectomy-angioplasty device further includes an expandable stent over the elongate balloon in the ready-to-deploy state of the atherectomy-angioplasty device. In some embodiments, the atherectomy-angioplasty device further includes a retractable sheath over the elongate balloon in the ready-to-deploy state of the atherectomy-angioplasty device. In some embodiments, the elongate balloon includes a coating of an antiproliferative drug on an external surface of the elongate balloon. The retractable sheath protects the coating prior to retracting the retractable sheath and inflating the elongate balloon for angioplasty therewith. In some embodiments, the elongate rotor approximates a shaftless screw auger that creates a vacuum for aspirating atherosclerotic debris into the rotor lumen when the shaftless screw auger is rotated around its longitudinal axis in the rotor lumen. In some embodiments, the plaque-debulking element is a rotatable cutting tip coupled to the tubular body. The cutting tip is coupled to the shaftless screw auger such that the cutting tip rotates around its longitudinal axis for cutting atherosclerotic or restenotic plaques away from the blood-vessel lumen of the patient when the shaftless screw auger is rotated around its longitudinal axis in the rotor lumen. In some embodiments, the cutting tip includes at least one side aperture in fluid communication with the rotor lumen. The side aperture allows the atherosclerotic debris to be aspirated into the rotor lumen for extracorporeal collection of the atherosclerotic debris. In some embodiments, an absence of a shaft in the shaftless screw auger provides a guidewire lumen for a guidewire. In some embodiments, the elongate rotor approximates a coiled-spring cable. In some embodiments, the plaque-debulking element is an abrasive mass in a distal portion of the coiled-spring cable. The abrasive mass orbits around a longitudinal axis of the coiled-spring cable for abrading atherosclerotic or restenotic plaques away from the blood-vessel lumen of the patient when the coiled-spring cable is rotated around its longitudinal axis in the rotor lumen. In some embodiments, the abrasive mass includes an abrasive