# US 12,004,757 B2 · Aspiration thrombectomy system and methods for thrombus removal with aspiration catheter > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,004,757 B2 - Document ID: US12004757B2 - Status: Granted - Kind: B2 - Application number: 18/345,991 - Filed: 2023-06-30 - Published: 2023-10-26 - Granted: 2024-06-11 - Earliest claimed: 2018-07-20 - Assignees: RapidPulse, Inc. - Applicants: RapidPulse, Inc. - Inventors: Derek Dee Deville; Matthew A. Palmer; William T. Bales; M. Sean McBrayer; Eric Petersen; Richard Cartledge; Thomas O. Bales, Jr.; Carlos Rivera - Web page: https://patentgrep.com/patent/US12004757B2 ## CPC - A61B 17/22: Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for - A61F 2/013: {Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting} - A61M 1/74: {Suction control (underwater drainage A61M1/61)} - A61M 1/742: {by changing the size of a vent (A61M1/7411 takes precedence)} - A61M 1/743: {by changing the cross-section of the line, e.g. flow regulating valves (A61M1/7413 takes precedence)} - A61M 1/75: {Intermittent or pulsating suction (A61M1/63, A61M1/772 take precedence)} - A61M 1/79: {Filters for solid matter (specially adapted for dental use A61C17/065)} - A61M 25/0075: {Valve means} - A61B 2017/00022: {Sensing or detecting at the treatment site} - A61B 2017/00154: {pulsed} - A61B 2017/22079: {with suction of debris} - A61B 2017/22082: {after introduction of a substance} - A61B 2217/005: with suction drainage system - A61B 2217/007: with irrigation system - A61F 2/011: {Instruments for their placement or removal} - A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00}) - A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) - A61M 2210/0693: Brain, cerebrum - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - 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 clot removal system comprises a catheter, a vacuum source, and a controller. The catheter comprises a proximal end, a distal end, and controller operating parameters and defines a lumen configured to be filled with a liquid column having a proximal portion. The vacuum source is configured to supply vacuum. The controller is configured to carry out a control pattern of turning on and off the vacuum based upon the controller operating parameters and is configured to receive the controller operating parameters in an automatic response to the catheter being operatively connected to at least one of the vacuum source and the controller and, responsive to the connection, to carry out the control pattern to change a level of vacuum at the distal end of the catheter. ## Claims ### Claim 1 An aspiration thrombectomy system, comprising: a catheter system including an aspiration catheter having a proximal portion, a distal end, and a lumen extending through the aspiration catheter; a vacuum source fluidically coupled to the catheter system; a vacuum valve fluidically coupled to the vacuum source and the proximal portion of the aspiration catheter to control a vacuum flow in the catheter lumen; a vent valve fluidically coupled to the proximal portion of the aspiration catheter, the vent valve being configured to control a flow of a vent fluid in the catheter lumen; and a controller configured to cyclically open and close the vacuum valve and the vent valve in a predetermined repeated cycle having a vacuum-only state in which the vacuum valve is open and the vent valve is closed, an off-off state in which both the vacuum valve and the vent valve are closed, and a vent-only state in which the vent valve is open and the vacuum valve is closed, wherein the off-off state is a programmed predetermined period of time less than the time for a pressure pulse caused by closing the vacuum valve to propagate to the distal end of the catheter. ### Claim 2 (depends on 1) The system of claim 1, further comprising a vent fluid source, wherein the controller is configured to cyclically open and close the vacuum valve and the vent valve to alternate between a negative pressure phase and a positive pressure phase at the distal end of the aspiration catheter during each cycle such that an exit flow occurs at the distal end during at least a portion of the positive pressure phase. ### Claim 3 (depends on 2) The system of claim 2 wherein the controller is configured to cyclically open and close the vacuum valve and the vent valve such that the exit flow is less than 20 microliters before fluid is drawn back into the catheter lumen. ### Claim 4 (depends on 1) The system of claim 1 wherein the vacuum-only state is 40-60% of the cycle, the vent-only state is approximately 20-25% of the cycle, and the off-off state is the remainder of the cycle. ### Claim 5 (depends on 1) The system of claim 1 wherein the off-off state is about 10 ms. ### Claim 6 (depends on 5) The system of claim 5 wherein the off-off state is not more than 30 ms. ### Claim 7 (depends on 1) The system of claim 1 wherein the off-off state is about 8% to about 24% of each cycle. ### Claim 8 (depends on 1) The system of claim 1 wherein the off-off state is about 12% to about 36% of each cycle. ### Claim 9 (depends on 1) The system of claim 1 wherein: the off-off state comprises a first off-off state after the vacuum-only state and before the vent-only state; the predetermined repeated cycle further comprises a second off-off state after the vent-only state and before a subsequent vacuum-only state of a subsequent cycle; and the second off-off state is a programmed predetermined period of time. ### Claim 10 A method for removing thromboembolic material, comprising: positioning the distal end of a catheter at least proximate to thromboembolic material in a blood vessel of a person, wherein the catheter has a proximal portion, a distal end and a lumen extending from the proximal portion to the distal end; and controlling a vacuum valve fluidically coupled to a vacuum source and the catheter and a vent valve fluidically coupled to a vent fluid source and the catheter according to a predetermined cycle having a vacuum-only state in which the vacuum valve is open and the vent valve is closed, an off-off state in which both the vacuum valve and the vent valve are closed, and a vent-only state in which the vent valve is open and the vacuum valve is closed, wherein the off-off state is a programmed predetermined period of time less than the time for a pressure pulse caused by closing the vacuum valve to propagate to the distal end of the catheter. ### Claim 11 (depends on 10) The method of claim 10 wherein controlling the vacuum valve and the vent valve comprises cyclically opening and closing the vacuum valve and the vent valve to alternate between a negative pressure phase and a positive pressure phase at the distal end of the catheter during each cycle and limiting movement of a fluid column in the catheter lumen at the distal end of the catheter such that a positive amount of exit flow occurs within a within a specific volume of fluid during at least a portion of the positive pressure phase. ### Claim 12 (depends on 11) The method of claim 11 wherein the specific volume is less than 20 microliters. ### Claim 13 (depends on 10) The method of claim 10 wherein the vacuum-only state is 40-60% of the cycle, the vent-only state is approximately 20-22% of the cycle, and the off-off state is the remainder of the cycle. ### Claim 14 (depends on 10) The method of claim 10 wherein the controlling the vacuum valve and the vent valve comprises opening and closing the vacuum valve and the vent valve in cycles of approximately 6 Hz to approximately 16 Hz, wherein during each cycle a change in level of vacuum at the distal end of the catheter is at least approximately 15 inHg to 25 inHg in a time of not greater than approximately 20 ms.