# US 12,178,999 B2 · Syringe systems and methods for bodily fluid collection and sampling > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,999 B2 - Document ID: US12178999B2 - Status: Granted - Kind: B2 - Application number: 17/728,215 - Filed: 2022-04-25 - Published: 2022-08-11 - Granted: 2024-12-31 - Earliest claimed: 2016-06-15 - Assignees: True Concepts Medical Technologies, LLC - Applicants: True Concepts Medical Technologies, LLC - Inventors: Michael Hopkins - Web page: https://patentgrep.com/patent/US12178999B2 ## CPC - A61M 5/19: having more than one chamber - A61B 5/15003: {for venous or arterial blood} - A61B 5/150221: {Valves} - A61B 5/150236: {Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood} - A61B 5/150244: {Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood} - A61B 5/150251: {Collection chamber divided into at least two compartments, e.g. for division of samples (injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755)} - A61B 5/150351: {Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel} - A61B 5/150992: {Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; Blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings or valves} - A61B 5/153: {Devices} specially adapted for taking samples of venous or arterial blood, e.g. with syringes - A61B 5/154: {Devices} using pre-evacuated means - A61M 5/284: {comprising means for injection of two or more media, e.g. by mixing} - A61M 5/31513: {Piston constructions to improve sealing or sliding} - A61M 5/3158: {the component being manually operated or triggered by an axially moving actuator operated by user, e.g. an axially movable injection button} - A61M 5/31596: {comprising means for injection of two or more media, e.g. by mixing} - A61M 5/32: Needles; Details of needles pertaining to their connection with syringe or hub (infusion needles A61M5/158); Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles - A61P 9/00: Drugs for disorders of the cardiovascular system - A61M 2005/1787: {Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid} - A61M 2005/3128: {Incorporating one-way valves, e.g. pressure-relief or non-return valves} - A61M 2202/04: Liquids - 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) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract A syringe-based device for procuring bodily fluid samples can include a housing having a port that can be coupled to a lumen-defining device for receiving bodily fluids, an actuator mechanism including a pre-sample reservoir, a removable plunger cap operably coupled with pre-sample reservoir, a plunger tube, a valve, a plunger seal, and a selectively attachable collection vial for capturing a bodily fluid sample. ## Claims ### Claim 1 A syringe-based device for procuring bodily fluid samples comprising: (a) a housing defining an inner volume and being configured to receive fluids; and (b) an actuator mechanism, the actuator mechanism being movable relative to the housing, the actuator mechanism including; (i) a pre-sample container having a proximal end and a distal end, wherein the pre-sample container defines a first fluid reservoir; (ii) a removable plunger cap being configured to be operably coupled with the pre-sample container; (iii) a plunger tube, the plunger tube being selectively engaged with the removable plunger cap, wherein the removable plunger cap is threadedly coupled with the plunger tube, and wherein the plunger tube includes a cannula assembly; and (iv) a plunger seal, the plunger seal being movable relative to the housing to define a second fluid reservoir in cooperation with the housing; wherein the actuator mechanism transitions from a first configuration in which a first portion of a bodily fluid flows into the first fluid reservoir, to a second configuration in which a second portion of the bodily fluid flows into the second fluid reservoir. ### Claim 2 (depends on 1) The syringe-based device of claim 1, wherein the pre-sample container is a fluid collection vial having a defined volume. ### Claim 3 (depends on 2) The syringe-based device of claim 2, wherein the defined volume of the pre-sample container is from 3 ml to 5 ml. ### Claim 4 (depends on 1) The syringe-based device of claim 1, wherein threadedly decoupling the removable plunger cap from the plunger tube permits the pre-sample container containing the first portion of the bodily fluid to be removed from the plunger tube. ### Claim 5 (depends on 1) The syringe-based device of claim 1, wherein the pre-sample container is selectively removable from the plunger tube. ### Claim 6 (depends on 1) The syringe-based device of claim 1, further comprising a sample collection reservoir, wherein the sample collection reservoir is attached to the cannula assembly after the pre-sample container is removed such that the sample collection reservoir draws the second portion of the bodily fluid from the second fluid reservoir. ### Claim 7 (depends on 1) The syringe-based device of claim 1, wherein a distal end portion of the housing includes a port configured to be coupled with a lumen-defining device. ### Claim 8 A syringe-based device for procuring bodily fluid samples comprising: (a) a housing defining an inner volume; and (b) an actuator mechanism being movable relative to the housing, the actuator mechanism including; (i) a pre-sample container defining a pre-sample reservoir; (ii) a removable plunger cap being configured to be operably coupled with the with the pre-sample container; (iii) a plunger tube, the plunger tube being selectively engaged with the removable plunger cap, (iv) a cannula assembly retained by the plunger tube; and (v) a plunger seal, the plunger seal being movable relative to the housing to define a second fluid reservoir in cooperation with the housing; wherein the actuator mechanism transitions from a first configuration in which a first portion of a bodily fluid flows into the pre-sample reservoir, to a second configuration in which a second portion of the bodily fluid flows into the second fluid reservoir. ### Claim 9 (depends on 8) The syringe-based device of claim 8, wherein the pre-sample container is a fluid collection vial having a defined volume. ### Claim 10 (depends on 9) The syringe-based device of claim 9, wherein the defined volume of the pre-sample container is from 3 ml to 5 ml. ### Claim 11 (depends on 8) The syringe-based device of claim 8, wherein the removable plunger cap is threadedly coupled with the plunger tube. ### Claim 12 (depends on 11) The syringe-based device of claim 11, wherein threadedly decoupling the removable plunger cap from the plunger tube permits the pre-sample container containing the first portion of the bodily fluid to be removed from the plunger tube. ### Claim 13 (depends on 8) The syringe-based device of claim 8, wherein the pre-sample container is selectively removable from the plunger tube. ### Claim 14 (depends on 8) The syringe-based device of claim 8, further comprising a sample collection reservoir, wherein the sample collection reservoir is attached to the cannula assembly after the pre-sample container is removed such that the sample collection reservoir draws the second portion of the bodily fluid from the second fluid reservoir. ### Claim 15 (depends on 1) The syringe-based device of claim 1, wherein a distal end portion of the housing includes a port configured to be coupled with a lumen-defining device. ### Claim 16 A syringe-based device for procuring bodily fluid samples comprising: (a) a housing defining an inner volume; and (b) an actuator mechanism being movable relative to the housing, the actuator mechanism including; (i) a pre-sample container defining a pre-sample reservoir; (ii) a plunger cap being configured to be operably coupled with the with the pre-sample container; (iii) a plunger tube, the plunger tube being selectively engaged with the plunger cap, (iv) a cannula assembly retained by the plunger tube; and (v) a plunger seal, the plunger seal being movable relative to the housing to define a second fluid reservoir in cooperation with the housing. ### Claim 17 (depends on 16) The syringe-based device of claim 16, wherein the pre-sample container is a fluid collection vial having a defined volume. ### Claim 18 (depends on 17) The syringe-based device of claim 17, wherein the pre-sample container is selectively removable from the plunger tube. ### Claim 19 (depends on 16) The syringe-based device of claim 16, further comprising a sample collection reservoir, wherein the sample collection reservoir is attached to the cannula assembly after the pre-sample container is removed such that the sample collection reservoir draws a portion of a bodily fluid from the second fluid reservoir. ### Claim 20 (depends on 16) The syringe-based device of claim 16, wherein the cannula assembly is in fluid communication with the second fluid reservoir, and a vacuum collection device can be selectively coupled with the cannula assembly.