US-12622715-B1 - Apparatus and methods for controlled clot aspiration

US12622715B1US 12622715 B1US12622715 B1US 12622715B1US-12622715-B1

Abstract

A sensor-controlled thrombectomy system includes an aspiration catheter, an aspiration pump, a collection canister, aspiration tubing, an external unit separate containing a medial portion of the aspiration tubing, a sensing unit within the external unit, and a controller that can utilize an algorithm to generate pressure pulses in the sensor-controlled thrombectomy system. During a thrombectomy procedure, the controller can operate the sensor-controlled thrombectomy system in a first mode to generate pressure pulses at a first pulse frequency to minimize blood loss while extracting a thrombus, detect, directly via the sensing unit, a first measure of flow through the aspiration tubing, and operate, automatically in response to the detected first measure of flow, the sensor-controlled thrombectomy system in a second mode to generate pressure pulses at a second pulse frequency, the second pulse frequency being an increased frequency relative to the first frequency to boost optimization for extracting the thrombus.

Inventors

Scott Teigen
Steven Loisel
Stephen Pons
Ben Tompkins

Assignees

PENUMBRA, INC.

Dates

Publication Date: 20260512
Application Date: 20251202

Claims (20)

1 . A sensor-controlled thrombectomy system, comprising: an aspiration catheter; an aspiration pump configured to generate controllable levels of negative pressure to the sensor-controlled thrombectomy system; a collection canister configured to be removably received by the aspiration pump; aspiration tubing comprising a proximal end and a distal end, wherein the distal end is configured to be coupled to the aspiration catheter, wherein the proximal end is configured to be coupled to the collection canister, and wherein the aspiration tubing is configured to provide fluid communication between the aspiration catheter, the collection canister, and the aspiration pump; an external unit separate from the aspiration pump and the collection canister, wherein a medial portion of the aspiration tubing is configured to be situated within the external unit; a sensing unit configured to directly detect flow in the aspiration tubing, wherein the sensing unit is situated within the external unit; and a controller configured to utilize an algorithm to generate pressure pulses during a thrombectomy procedure, the controller being further configured to: operate, via the algorithm, the sensor-controlled thrombectomy system in a first mode, wherein the first mode comprises generating pressure pulses at a first pulse frequency, and wherein the first pulse frequency is configured to minimize blood loss while extracting a thrombus; detect, directly via the sensing unit, a first measure of flow through the aspiration tubing; and operate, automatically via the algorithm in response to the detected first measure of flow, the sensor-controlled thrombectomy system in a second mode, wherein the second mode comprises generating pressure pulses at a second pulse frequency, wherein the second pulse frequency is an increased frequency relative to the first pulse frequency, and wherein the increased frequency boosts a level of optimization for extracting the thrombus.
2 . The sensor-controlled thrombectomy system of claim 1 , wherein the sensing unit comprises one or more acoustic flow sensors.
3 . The sensor-controlled thrombectomy system of claim 2 , wherein the one or more acoustic flow sensors are ultrasonic flow sensors.
4 . The sensor-controlled thrombectomy system of claim 3 , wherein the ultrasonic flow sensors in the sensing unit are capable of detecting when flow through the aspiration tubing is one of a plurality of flow states comprising an excessive flow state and a clogged flow state.
5 . The sensor-controlled thrombectomy system of claim 1 , wherein the controller is configured to operate, via the algorithm, the sensor-controlled thrombectomy system in a plurality of modes, and wherein the plurality of modes comprises the first mode and the second mode.
6 . The sensor-controlled thrombectomy system of claim 5 , wherein the controller is configured to change, via the algorithm, operation of the sensor-controlled thrombectomy system between the plurality of modes in order to minimize blood loss during the thrombectomy procedure.
7 . The sensor-controlled thrombectomy system of claim 5 , further comprising one or more indicator lights associated with operation of the sensor-controlled thrombectomy system.
8 . The sensor-controlled thrombectomy system of claim 7 , wherein the one or more indicator lights are configured to provide visual indications to a user of the sensor-controlled thrombectomy system using a plurality of visual colors.
9 . The sensor-controlled thrombectomy system of claim 7 , wherein the one or more indicator lights are configured to provide a plurality of visual indications corresponding to a current mode of operation of the sensor-controlled thrombectomy system.
10 . The sensor-controlled thrombectomy system of claim 9 , wherein a first visual indication is indicative of the sensor-controlled thrombectomy system operating in the first mode and a second visual indication is indicative of the sensor-controlled thrombectomy system operating in the second mode.
11 . The sensor-controlled thrombectomy system of claim 1 , wherein one or more of the first pulse frequency or the second pulse frequency are predetermined frequencies.
12 . The sensor-controlled thrombectomy system of claim 1 , wherein one or more of the first pulse frequency or the second pulse frequency are dynamic frequencies based at least in part on the sensing unit in the external unit.
13 . The sensor-controlled thrombectomy system of claim 1 , wherein the medial portion of the aspiration tubing within the external unit extends from a distal opening of the external unit to a proximal end of the external unit.
14 . The sensor-controlled thrombectomy system of claim 1 , wherein the external unit is configured to communicate electronically with the aspiration pump.
15 . The sensor-controlled thrombectomy system of claim 1 , wherein the external unit comprises one or more physical controls configured to be operated by a user of the sensor-controlled thrombectomy system.
16 . The sensor-controlled thrombectomy system of claim 15 , wherein one or more of the physical controls of the external unit control switching one or more components of the sensor-controlled thrombectomy system on or off.
17 . The sensor-controlled thrombectomy system of claim 1 , wherein the aspiration pump comprises one or more physical controls configured to be operated by a user of the sensor-controlled thrombectomy system.
18 . A dynamic aspiration method associated with a sensor-controlled thrombectomy system comprising an aspiration catheter, an aspiration pump, a collection canister, aspiration tubing, an external unit, and a sensing unit in the external unit, the dynamic aspiration method comprising: operating, by a controller of the sensor-controlled thrombectomy system, via an algorithm, the sensor-controlled thrombectomy system in a first mode, wherein the first mode comprises generating pressure pulses at a first pulse frequency, and wherein the first pulse frequency is configured to minimize blood loss while extracting a thrombus; detecting, directly via the sensing unit, a first measure of flow through the aspiration tubing; and operating, automatically via the algorithm in response to the detected first measure of flow, the sensor-controlled thrombectomy system in a second mode, wherein the second mode comprises generating pressure pulses at a second pulse frequency, wherein the second pulse frequency is an increased frequency relative to the first pulse frequency, and wherein the increased frequency boosts a level of optimization for extracting the thrombus.
19 . The dynamic aspiration method of claim 18 , wherein the sensing unit comprises one or more acoustic flow sensors.
20 . The dynamic aspiration method of claim 19 , wherein the one or more acoustic flow sensors are ultrasonic flow sensors.

Description

PRIORITY This application is a continuation under 35 U.S.C. § 120 of U.S. patent application Ser. No. 19/171,050, filed 4 Apr. 2025, which is a continuation under 35 U.S.C. § 120 of U.S. patent application Ser. No. 19/018,575, filed 13 Jan. 2025, which is a continuation under 35 U.S.C. § 120 of U.S. patent application Ser. No. 18/741,638, filed 12 Jun. 2024, now issued as U.S. Pat. No. 12,193,690, which is a continuation under 35 U.S.C. § 120 of U.S. patent application Ser. No. 18/532,982, filed 7 Dec. 2023, now issued as U.S. Pat. No. 12,150,660, which is a continuation under 35 U.S.C. § 120 of U.S. patent application Ser. No. 18/469,445, filed 18 Sep. 2023, which is a continuation under 35 U.S.C. § 120 of U.S. patent application Ser. No. 16/977,431, filed 1 Sep. 2020, now issued as U.S. Pat. No. 11,759,219, which is a U.S. National Stage Patent Application under 35 U.S.C. § 371 of PCT International Application No. PCT/US2019/043095, filed 23 Jul. 2019, which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62/778,708, filed 12 Dec. 2018, and of U.S. Provisional Patent Application No. 62/702,804, filed 24 Jul. 2018, each of which are incorporated herein by reference. TECHNICAL FIELD The present invention relates generally to the field of medical devices and methods. More specifically, the invention described herein relates to devices and methods for controlling clot removal from a patient's vasculature by aspiration thrombectomy. BACKGROUND Stroke is a significant cause of disability and death, and a growing problem for global healthcare. More than 700,000 people in the United States alone suffer a stroke each year, and of these, more than 150,000 people die. Of those who survive a stroke, roughly 90% will suffer long term impairment of movement, sensation, memory, or reasoning, ranging from mild to severe. The total cost to the U.S. healthcare system is estimated to be over $50 billion per year. Stroke may be caused by a blockage in a cerebral artery resulting from a thromboembolism (referred to as an “ischemic stroke”), or by a rupture of a cerebral artery (referred to as a “hemorrhagic stroke”). Hemorrhagic stroke results in bleeding within the skull, limiting blood supply to brain cells, and placing harmful pressure on delicate brain tissue. Blood loss, swelling, herniation of brain tissue, and pooling of blood that results in formation of clot mass inside the skull all rapidly destroy brain tissue. Hemorrhagic stroke is a life-threatening medical emergency with limited treatment options. Aside from cerebral stroke, thromboembolism throughout the vasculature, in both arterial and venous circulation, is characteristic of numerous common, life-threatening conditions. Examples of potentially fatal diseases resulting from thrombotic occlusion include pulmonary embolism, deep vein thrombosis, and acute limb ischemia. Acute pulmonary embolism is a significant cause of death in the United States, with roughly 300,000 patients dying each year. Pulmonary embolism can be a complication from deep vein thrombosis, which has an annual incidence of 1% in patients 60 years and older. All of the aforementioned diseases are examples of conditions in which treatment may include aspiration or evacuation of clot and/or blood. Of particular interest to the present invention, the Penumbra System® mechanical thrombectomy system is a fully-integrated system designed specifically for mechanical thrombectomy by aspiration. It is intended for revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusion. A comparable system designed for the peripheral and coronary vasculature, the Indigo® System is also a mechanical thrombectomy aspiration system, designed for revascularization of patients with thrombotic occlusion of the peripheral vasculature. Both the Penumbra System and the Indigo System are commercially available at the time of filing the present provisional patent application and include aspiration or reperfusion catheters, aspiration tubing, other accessories, and an aspiration pump (sold under the tradename: Pump MAX™ aspiration pump or Penumbra Engine™ aspiration pump) for connection to the aspiration tubing and aspiration catheters. As illustrated in FIG. 1, the Pump MAX™ aspiration pump 10 includes a base unit 12 which encloses a vacuum pump (not shown) which operates off line voltage. The base unit has an on-off switch 14 and a separate knob 16 for adjusting the level of vacuum provided by the pump. The vacuum level can be read on a pressure gauge 18. Blood and clot are drawn into a collection canister 20 from an aspiration tube 22 (shown in broken line) which is connected to a reperfusion catheter (not illustrated) which has been introduced to the vasculature of a patient to aspirate clot. The blood and clot are drawn into the collection canister by a partial vacuum which is provided by a vacuum connector 28 on the base unit 12 which i