# US 12,109,353 B2 · Dynamic pressure response and catheter occlusion system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,353 B2 - Document ID: US12109353B2 - Status: Granted - Kind: B2 - Application number: 17/542,060 - Filed: 2021-12-03 - Published: 2022-06-09 - Granted: 2024-10-08 - Earliest claimed: 2020-12-04 - Assignees: C. R. Bard, Inc. - Applicants: C. R. Bard, Inc. - Inventors: Jason Jishen Cheng; David M. Simiele; Varad Chavan - Web page: https://patentgrep.com/patent/US12109353B2 ## CPC - A61M 1/83: {Tube strippers, i.e. for clearing the contents of the tubes} - A61M 1/84: {Drainage tubes; Aspiration tips (for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32)} - A61M 1/69: {Drainage containers not being adapted for subjection to vacuum, e.g. bags (devices worn by the patient for reception of urine A61F5/44)} - A61M 1/743: {by changing the cross-section of the line, e.g. flow regulating valves (A61M1/7413 takes precedence)} - A61M 1/94: {with gas supply means} - A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections} - A61M 2202/0496: Urine - A61M 2205/33: Controlling, regulating or measuring - A61M 2205/3344: Measuring or controlling pressure at the body treatment site - 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 Embodiments disclosed herein are directed to a dynamic response drainage and occlusion system configured to drain a fluid from a patient. The drainage system includes an input airflow device to provide airflow into the drainage lumen, a pressure sensor to measure pressure within the drainage tube, and an output airflow device to provide airflow out of the drainage tube. A controller including control logic configured to acquire pressure data from the pressure sensor, determine a running pressure rate-of-change from the acquired pressure data, compare the running pressure rate-of-change with a pressure rate-of-change defined by the control logic, and adjust an operating characteristic of at least one of the input airflow device and the output airflow device to move the running pressure rate-of-change toward the pressure rate-of-change defined by the control logic. The system further includes catheter occlusions systems to automatically protect the patient from pressure spikes within the system. ## Claims ### Claim 1 A drainage system for draining a fluid from a patient, the drainage system comprising: a drainage tube configured to provide fluid communication between a catheter and a collection container; an input airflow device coupled to the drainage tube and configured to provide airflow into the drainage tube; a pressure sensor operatively coupled to the drainage tube to measure an internal pressure of the drainage tube; an output airflow device coupled to the collection container to draw airflow out of the drainage tube; and a controller communicatively coupled to the pressure sensor, the input airflow device, and the output airflow device, the controller including control logic configured to: (i) acquire pressure data from the pressure sensor; (ii) determine a running pressure rate-of-change from the acquired pressure data; (iii) compare the running pressure rate-of-change with a pressure rate-of-change defined by the control logic; (iv) adjust an operating characteristic of at least one of the input airflow device and the output airflow device to move the running pressure rate-of-change toward the pressure rate-of-change defined by the control logic; and (v) measuring a pressure noise level to determine a presence of droplets within the drainage tube and modifying the input airflow device from a first airflow rate to a second airflow rate by modifying the pressure rate-of-change defined by the control logic. ### Claim 2 (depends on 1) The system according to claim 1, wherein the control logic is configured to adjust the operating characteristic of the output airflow device to move the running pressure rate-of-change toward the pressure rate-of-change defined by the control logic. ### Claim 3 (depends on 1) The system according to claim 1, wherein the control logic is configured to: compare the running pressure rate-of-change with a positive pressure rate-of-change limit defined by the control logic; and deactivate the input airflow device when the running pressure rate-of-change exceeds the positive pressure rate-of-change limit. ### Claim 4 (depends on 1) The system according to claim 1, wherein the control logic is configured to: compare the running pressure rate-of-change with a negative pressure rate-of-change limit defined by the control logic; and deactivate the output airflow device when the running pressure rate-of-change exceeds the negative pressure rate-of-change limit. ### Claim 5 (depends on 1) The system according to claim 1, wherein the control logic is configured to: determine the internal pressure of the drainage tube from the acquired pressure data; compare the internal pressure with a positive pressure limit defined by the control logic; and deactivate the input airflow device when the internal pressure exceeds the positive pressure limit defined by the control logic. ### Claim 6 (depends on 5) The system according to claim 5, wherein the control logic is configured to: compare the internal pressure with a negative pressure limit defined by the control logic; and deactivate the output airflow device when the internal pressure exceeds the negative pressure limit. ### Claim 7 (depends on 1) The system according to claim 1, further comprising a valve coupled in line with the drainage tube at a location distal the input airflow device, wherein the valve is configured to selectively allow fluid flow through the valve when open and prevent fluid flow through the valve when closed. ### Claim 8 (depends on 7) The system according to claim 7, wherein the valve is coupled to the controller, and wherein the control logic is configured to close the valve when at least one of the input airflow device and the output airflow device is activated. ### Claim 9 (depends on 7) The system according to claim 7, wherein the valve includes a catheter occlusion system having a body defining a channel configured to receive a portion of the catheter therein, and a first inflation chamber configured to transition between a deflated state and an inflated state, a portion of the first inflation chamber extending into the channel in the inflated state to compress the catheter and occlude a lumen of the catheter. ### Claim 10 (depends on 9) The system according to claim 9, wherein the first inflation chamber includes one of an expandable balloon or a piston having a piston head slidably engaged therewith. ### Claim 11 (depends on 9) The system according to claim 9, wherein the first inflation chamber extends between the deflated state and the inflated state along an inflation axis that extends perpendicular to a longitudinal axis of the catheter, the inflation axis being offset from a radial mid-point of the lumen of the catheter, disposed between a channel opening and the radial mid-point of the lumen of the catheter. ### Claim 12 (depends on 9) The system according to claim 9, wherein the body encircles the catheter through an arc of 360° and defines a toroidal cross-sectional shape. ### Claim 13 (depends on 9) The system according to claim 9, further including an inflation line coupled to the input airflow device and configured to provide an inflation fluid to the first inflation chamber. ### Claim 14 (depends on 7) The system according to claim 7, further comprising a safety pressure sensor operatively coupled to the drainage tube distal the valve, wherein the safety pressure sensor is coupled to the controller, and wherein the control logic is configured to: acquire pressure data from the safety pressure sensor; determine an internal pressure of the catheter from the acquired pressure data from the safety pressure sensor; compare the internal pressure of the catheter with at least one of a positive pressure limit for the catheter and a predefined negative pressure limit for the catheter; and deactivate the input airflow device and the output airflow device when the internal pressure of the catheter exceeds a predefined positive pressure limit for the catheter or the predefined negative pressure limit for the catheter. ### Claim 15 (depends on 1) The system according to claim 1, wherein the control logic is configured to: acquire pressure data from the pressure sensor while the input airflow device is deactivated; generate one or more pressure parameters from the pressure data; compare the one or more pressure parameters with one or more corresponding pressure parameter limits defined by the control logic; and activate the input airflow device when a pressure parameter exceeds at least one of the one or more corresponding pressure parameter limits. ### Claim 16 (depends on 1) The system according to claim 1, wherein the control logic is configured to deactivate the input airflow device after a predefined activation time period defined by the control logic. ### Claim 17 (depends on 1) The system according to claim 1, further comprising a hydrophobic filter coupled in line with the drainage tube between the collection container and the output airflow device. ### Claim 18 (depends on 1) The system according to claim 1, wherein the catheter is a Foley catheter configured to drain the fluid from a bladder of the patient. ### Claim 19 A method of draining fluid from a patient, comprising: providing a drainage system comprising: a drainage tube extending between a catheter and a collection container, wherein the drainage tube, the catheter and the collection container are in fluid communication with each other; a pressure sensor operatively coupled to the drainage tube to measure pressure within the drainage tube; an input airflow device coupled to the drainage tube at a distal end to provide airflow into the drainage tube; a valve coupled in line with the drainage tube between the catheter and the input airflow device, wherein the valve is configured to selectively allow fluid flow through the valve when open and prevent fluid flow through the valve when closed; an output airflow device coupled to the drainage tube at a proximal end, the output airflow device configured to draw airflow out of the drainage tube; and a controller including control logic, the controller coupled to the pressure sensor, the input airflow device, the output airflow device, and the valve; acquiring pressure data from the pressure sensor; generating one or more pressure parameters from the pressure data, including a pressure rate-of-change, a running pressure rate-of-change, and a pressure noise level; comparing the one or more pressure parameters with one or more corresponding pressure parameter limits; and activating the input airflow device when at least one pressure parameter exceeds at least one of the one or more corresponding pressure parameter limits including measuring the pressure noise level to determine a presence of droplets within the drainage tube and modifying the input airflow device from a first airflow rate to a second airflow rate.