# US 11,433,183 B2 · System for diagnosing and treating microvascular obstructions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,433,183 B2 - Document ID: US11433183B2 - Status: Granted - Kind: B2 - Application number: 16/297,339 - Filed: 2019-03-08 - Published: 2019-09-12 - Granted: 2022-09-06 - Earliest claimed: 2018-03-09 - Assignees: CorFlow Therapeutics AG - Applicants: CorFlow Therapeutics AG - Inventors: Robert S. Schwartz; Jon Helge Hoem; Martin T. Rothman - Web page: https://patentgrep.com/patent/US11433183B2 ## CPC - A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure} - A61B 5/6853: {with a balloon} - 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 - A61M 5/142: Pressure infusion, e.g. using pumps - A61M 25/0069: {Tip not integral with tube} - A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked} - 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}) - A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)} - A61B 2017/22084: {stone- or thrombus-dissolving} - A61M 5/16827: {controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths (infusion of multiple fluids without using a controller A61M5/1407)} - A61M 2005/1726: {the body parameters being measured at, or proximate to, the infusion site} - A61M 2025/0002: {with a pressure sensor at the distal end} - A61M 2025/09175: {having specific characteristics at the distal tip} - A61M 2205/3334: Measuring or controlling the flow rate - A61M 2230/30: Blood pressure (A61M2230/04 takes precedence) - 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)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Devices for the diagnosis and treatment of microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to detect and measure or treat MVO in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction-primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others. Using methods of the invention, a system comprising specialized infusion and sensing catheter, diagnostic agents, therapeutic agents, and control console with specialized algorithms can both diagnose and treat MVO by eliminating the microvascular clot and debris causing the obstruction. The techniques involve a combination of novel devices, methods, and software to simultaneously diagnose and treat MVO. ## Claims ### Claim 1 A system for delivering a controlled flow infusion comprising: a percutaneous transvascular catheter having a distal end, an infusion lumen and an occlusion balloon disposed near the distal end, the distal end of the percutaneous transvascular catheter sized and shaped for advancement into a blood vessel in fluid communication with microvasculature; a pump in fluid communication with the catheter; a plurality of infusates in fluid communication with the pump; and a controller coupled to the pump, the controller programmed to execute instructions to actuate the pump to deliver a preparatory pulse of a first infusate at a first flow rate and a first flow pressure and for a first interval, the first flow rate or the first flow pressure selected to inflate, open, or otherwise clear obstructive debris from hydrostatically closed channels of the microvasculature through physical agitation and without dissolution, and upon completion of the preparatory pulse, to actuate the pump to deliver a therapeutic pulse of a second infusate at a second flow rate and for a second interval, wherein the first flow rate is different than the second flow rate and the first interval is different than the second interval, and wherein the system is configurable to deliver the preparatory pulse while the occlusion balloon is inflated. ### Claim 2 (depends on 1) The system of claim 1, further comprising a guidewire having a pressure sensor configured to measure pressure. ### Claim 3 (depends on 2) The system of claim 2, wherein the controller is adapted to receive pressure measurements from the pressure sensor. ### Claim 4 (depends on 3) The system of claim 3, wherein the controller is configured to adjust delivery of one or more of the plurality of infusates based on one or more of the pressure measurements. ### Claim 5 (depends on 1) The system of claim 1, wherein the catheter includes a catheter pressure sensor, and the catheter pressure sensor is configured to measure pressure. ### Claim 6 (depends on 5) The system of claim 5, wherein the controller is adapted to receive pressure measurements from the catheter pressure sensor. ### Claim 7 (depends on 6) The system of claim 6, wherein the controller is configured to adjust delivery of one or more of the plurality of infusates based on one or more of the pressure measurements. ### Claim 8 (depends on 1) The system of claim 1, wherein the catheter includes pores in an outer wall of the catheter near the distal end of the catheter. ### Claim 9 (depends on 8) The system of claim 8, wherein the catheter includes a cap. ### Claim 10 (depends on 8) The system of claim 8 wherein the catheter includes a pressure sensing chamber disposed near the distal end of the catheter. ### Claim 11 (depends on 1) The system of claim 1, wherein the catheter includes jets. ### Claim 12 (depends on 11) The system of claim 11, wherein the jets comprise antegrade jets, retrograde jets, or both antegrade and retrograde jets. ### Claim 13 (depends on 1) The system of claim 1, wherein the catheter has a tapered distal end. ### Claim 14 (depends on 1) The system of claim 1, further comprising a sensor disposed near the distal end of the catheter, the sensor configured to generate a signal indicative of a sensed physiological parameter. ### Claim 15 (depends on 14) The system of claim 14, wherein the controller is configured to adjust delivery of one or more of the plurality of infusates based on the signal. ### Claim 16 (depends on 14) The system of claim 14, wherein the sensed physiological parameter is selected from at least one of pressure, flow, impedance, or other cardiac cycle parameter. ### Claim 17 (depends on 14) The system of claim 14, further comprising one or more additional sensors disposed near the distal end of the catheter. ### Claim 18 (depends on 1) The system of claim 1, wherein the controller is configured to: perform a measurement of the blood pressure after the first infusate is infused to the blood vessel via the catheter at the first flow rate; and perform a calculation of a microvascular resistance, the microvascular resistance being calculated by dividing the blood pressure measurement value by the second flow rate. ### Claim 19 (depends on 18) The system of claim 18, wherein the controller is further configured to determine change in a level of an MVO over the time period based on at least a dynamic microvascular resistance measurement performed at the different times. ### Claim 20 (depends on 1) The system of claim 1, wherein the first flow rate is greater than the second flow rate. ### Claim 21 (depends on 1) The system of claim 1, wherein the controller is further programmed to execute instructions to actuate the pump to deliver the therapeutic pulse of the second infusate at a second flow pressure, the second flow pressure lower than the first flow pressure.