# US 12,005,228 B2 · Systems and methods for correcting and preventing occlusion in a catheter > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,005,228 B2 - Document ID: US12005228B2 - Status: Granted - Kind: B2 - Application number: 16/436,726 - Filed: 2019-06-10 - Published: 2019-09-26 - Granted: 2024-06-11 - Earliest claimed: 2016-06-09 - Assignees: C. R. Bard, Inc. - Applicants: C. R. Bard, Inc. - Inventors: Gidon Ofek; Jay A. Muse; Bret Hamatake; Garrick T. Smith - Web page: https://patentgrep.com/patent/US12005228B2 ## CPC - A61M 5/1452: {pressurised by means of pistons} - A61M 1/3659: {Cannulae pertaining to extracorporeal circulation} - A61M 1/772: {operating alternately} - A61M 1/80: {Suction pumps (A61M1/64, A61M1/71, A61M60/00 take precedence)} - 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 39/225: {Flush valves, i.e. bypass valves for flushing line} - A61M 5/16863: {Occlusion detection} - A61M 2005/1403: {Flushing or purging} - A61M 2005/1588: {having means for monitoring, controlling or visual inspection, e.g. for patency check or for avoiding extravasation} - A61M 2025/0019: {Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement} - 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 A patency device for catheter assemblies and other elongate tubular devices used for establishing access to an interior body portion of a patient is disclosed. The patency device establishes and preserves patency of one or more lumens defined by the catheter assembly by providing impulses of positive pressure to fluid disposed in the lumen of the catheter assembly. In one embodiment, the patency device comprises a fluid reservoir configured to provide a fluid path to at least one lumen of the catheter assembly, and a pressure input portion. The pressure input portion is configured to provide pressure for one or more impulses of positive pressure to a fluid disposed within the lumen. The impulses are configured to dislodge occlusions that may have formed in the lumen. A negative pressure can then be provided to the lumen to aspirate the occlusion. ## Claims ### Claim 1 A catheter assembly, comprising: a catheter including a lumen; and a patency device connectable to the catheter, the patency device comprising: a fluid reservoir designed to be placed in fluid communication with the lumen; a positive pressure input portion having a distal end connected to the fluid reservoir, designed to provide at least one impulse of positive pressure to a fluid disposed within the lumen; an interface portion including a proximal end coupled to the fluid reservoir and a distal end coupled to the lumen; a normally closed two-way valve coupled in line between the fluid reservoir and the lumen; and a negative pressure input portion operably connected to a fluid outlet of the normally closed two-way valve. ### Claim 2 (depends on 1) The catheter assembly according to claim 1, wherein the at least one impulse is designed to dislodge an occlusion disposed in the lumen. ### Claim 3 (depends on 1) The catheter assembly according to claim 1, wherein the negative pressure input portion comprises a vacuum device. ### Claim 4 (depends on 3) The catheter assembly according to claim 3, wherein the vacuum device comprises a syringe pump or a vacuum pump. ### Claim 5 (depends on 3) The catheter assembly according to claim 3, wherein the vacuum device comprises a normally open valve. ### Claim 6 (depends on 5) The catheter assembly according to claim 5, wherein the normally open valve is designed to close upon opening of the normally closed two-way valve. ### Claim 7 (depends on 1) The catheter assembly according to claim 1, wherein the at least one impulse includes a series of impulses at a predetermined impulse frequency, and wherein the interface portion is disposable and provides a sterile barrier between the catheter and the patency device. ### Claim 8 (depends on 7) The catheter assembly according to claim 7, wherein the predetermined impulse frequency is at least 20 KHz. ### Claim 9 (depends on 1) The catheter assembly according to claim 1, wherein the positive pressure input portion is designed to provide multiple series of impulses in a predetermined impulse pattern, each of the multiple series including the at least one impulse. ### Claim 10 (depends on 9) The catheter assembly according to claim 9, wherein each of the multiple series of the impulses is separated by a rest period. ### Claim 11 (depends on 10) The catheter assembly according to claim 10, wherein the patency device is designed to provide a negative pressure to the fluid disposed within the lumen during each rest period. ### Claim 12 (depends on 1) The catheter assembly according to claim 1, wherein the patency device is designed to provide the at least one impulse at a pressure of at least 30 psi. ### Claim 13 (depends on 1) The catheter assembly according to claim 1, wherein the patency device is designed to provide the at least one impulse at a pressure that exceeds a burst pressure strength rating of the catheter. ### Claim 14 (depends on 1) The catheter assembly according to claim 1, further comprising a pressure transducer designed to provide data relating to a pressure within a fluid line of the patency device. ### Claim 15 (depends on 1) The catheter assembly according to claim 1, further comprising a controller designed to govern operation of the patency device, the controller including a processor. ### Claim 16 (depends on 1) The catheter assembly according to claim 1, wherein the positive pressure input portion includes at least one of a hydrostatic pump, an actuator, and a wave generator. ### Claim 17 (depends on 1) The catheter assembly according to claim 1, wherein the fluid reservoir includes at least one of a hydraulic accumulator and a syringe. ### Claim 18 (depends on 1) The catheter assembly according to claim 1, wherein the at least one impulse includes a rise-time phase of about 30 milliseconds, a holding high-pressure phase of about 200 milliseconds, and a pressure reduction phase of about 40 milliseconds.