# US 11,998,332 B2 · Fluid diversion mechanism for bodily-fluid sampling > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,998,332 B2 - Document ID: US11998332B2 - Status: Granted - Kind: B2 - Application number: 18/381,369 - Filed: 2023-10-18 - Published: 2024-02-08 - Granted: 2024-06-04 - Earliest claimed: 2012-05-30 - Assignees: Magnolia Medical Technologies, Inc. - Applicants: Magnolia Medical Technologies, Inc. - Inventors: Gregory J. Bullington; Richard G. Patton; Jay M. Miazga; Shan E. Gaw - Web page: https://patentgrep.com/patent/US11998332B2 ## CPC - A61B 5/150221: {Valves} - A61B 5/1405: {Devices for taking blood samples (devices for taking samples of other body liquids A61B10/0045)} - A61B 5/150099: {by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes} - A61B 5/150229: {Pumps for assisting the blood sampling} - 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 5/150251: {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 5/150946: {Means for varying, regulating, indicating or limiting the speed or time of blood collection} - 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 5/15003: {for venous or arterial blood} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir. ## Claims ### Claim 1 A bodily-fluid transfer device, comprising: a housing having an inlet port configured to be fluidically coupled to a bodily-fluid source and an outlet port configured to be fluidically coupled to a sample reservoir; a fluid reservoir disposed in the housing and at least partially defined by the housing, the fluid reservoir configured to receive and sequester a first amount of bodily-fluid withdrawn from the bodily-fluid source; and a flow controller disposed in an inner volume of the housing and forming a friction fit with an inner surface defining at least a portion of the inner volume, the flow controller configured to transition from (i) a first configuration in which the inlet port is in fluid communication with the fluid reservoir to facilitate a flow of the first amount of the bodily-fluid from the inlet port, through a first fluid flow path, to the fluid reservoir, to (ii) a second configuration in which the inlet port is in fluid communication with the outlet port to facilitate a flow of a second amount of the bodily-fluid from the inlet port, through a second fluid flow path, to the outlet port; the flow controller configured to automatically transition from the first configuration to the second configuration after the first amount of the bodily-fluid flows into to the fluid reservoir. ### Claim 2 (depends on 1) The bodily-fluid transfer device of claim 1, further comprising: a seal member at least partially disposed in the housing and in fluid communication with the fluid reservoir. ### Claim 3 (depends on 2) The bodily-fluid transfer device of claim 2, wherein the seal member is configured to form a substantially fluid tight seal with at least a portion of an inner surface of the housing. ### Claim 4 (depends on 2) The bodily-fluid transfer device of claim 2, wherein the seal member allows a negative pressure differential to form in the fluid reservoir such that the first amount of the bodily-fluid flows from the inlet port and into the fluid reservoir. ### Claim 5 (depends on 2) The bodily-fluid transfer device of claim 2, wherein the seal member defines a fluidic seal with inner walls of the housing to at least partially define the fluid reservoir such that the first amount of the bodily-fluid is contained therein. ### Claim 6 (depends on 1) The bodily-fluid transfer device of claim 1, wherein the first amount of the bodily-fluid is less than approximately 5 ml. ### Claim 7 (depends on 1) The bodily-fluid transfer device of claim 1, wherein the first amount of the bodily-fluid is at least a volume of a lumen of a needle fluidically coupled to the inlet port. ### Claim 8 (depends on 1) The bodily-fluid transfer device of claim 1, wherein the first amount of the bodily-fluid is at least a volume of a lumen of a lumen-containing device fluidically coupled to the inlet port. ### Claim 9 (depends on 1) The bodily-fluid transfer device of claim 1, wherein the first amount of the bodily-fluid is approximately 0.1 ml to approximately 5 ml. ### Claim 10 (depends on 1) The bodily-fluid transfer device of claim 1, wherein the outlet port is fluidically isolated from the fluid reservoir when the flow controller is in the second configuration. ### Claim 11 A bodily-fluid transfer device, comprising: a housing having an inlet port configured to be fluidically coupled to a bodily-fluid source and an outlet port configured to be fluidically coupled to a sample reservoir; a fluid reservoir disposed in the housing and at least partially defined by the housing, the fluid reservoir configured to receive a first amount of bodily-fluid withdrawn from the bodily-fluid source; a seal member at least partially disposed in the housing to at least partially define the fluid reservoir; and a flow controller disposed in an inner volume of the housing and forming a friction fit with an inner surface defining at least a portion of the inner volume, the flow controller configured to transition from (i) a first configuration in which the inlet port is placed in fluid communication with the fluid reservoir to facilitate a flow of the first amount of the bodily-fluid from the inlet port, through an inlet portion of the fluid reservoir, and then toward the seal member, to (ii) a second configuration in which the inlet port is placed in fluid communication with the outlet port to facilitate a flow of a second amount of the bodily-fluid from the inlet port toward the outlet port via a sampling path; the flow controller configured to transition from the first configuration to the second configuration only after the first amount of the bodily-fluid is at least partially disposed in the fluid reservoir and without manual intervention. ### Claim 12 (depends on 11) The bodily-fluid transfer device of claim 11, wherein the seal member is configured to form a substantially fluid tight seal with at least a portion of an inner surface of the housing. ### Claim 13 (depends on 11) The bodily-fluid transfer device of claim 11, wherein the seal member defines a fluidic seal with inner walls of the housing to at least partially define the fluid reservoir such that the first amount of the bodily-fluid is contained therein. ### Claim 14 (depends on 11) The bodily-fluid transfer device of claim 11, wherein the first amount of the bodily-fluid is less than approximately 5 ml. ### Claim 15 (depends on 11) The bodily-fluid transfer device of claim 11, wherein the first amount of the bodily-fluid is at least a volume of a lumen of a lumen-containing device fluidically coupled to the inlet port. ### Claim 16 (depends on 11) The bodily-fluid transfer device of claim 11, wherein the outlet port is fluidically isolated from the fluid reservoir when the flow controller is in the second configuration. ### Claim 17 (depends on 11) The bodily-fluid transfer device of claim 11, wherein the seal member allows a negative pressure differential to form in the fluid reservoir such that the first amount of the bodily-fluid flows from the inlet port and into the fluid reservoir. ### Claim 18 A bodily-fluid transfer device, comprising: a housing having an inlet port configured to be fluidically coupled to a bodily-fluid source and an outlet port configured to be fluidically coupled to a sample reservoir; a fluid reservoir disposed in the housing and at least partially defined by the housing, the fluid reservoir configured to receive and sequester a first amount of bodily-fluid withdrawn from the bodily-fluid source; a seal member at least partially disposed in the housing to at least partially define the fluid reservoir; and a flow controller disposed in an inner volume of the housing and forming a friction fit with an inner surface defining at least a portion of the inner volume, the flow controller configured to transition from (i) a first configuration in which the inlet port is placed in fluid communication with the fluid reservoir to facilitate a flow of the first amount of the bodily-fluid from the inlet port, through an inlet portion of the fluid reservoir, and then toward the seal member, to (ii) a second configuration in which the inlet port is placed in fluid communication with the outlet port to facilitate a flow of a second amount of the bodily-fluid from the inlet port toward the outlet port via a sampling path. ### Claim 19 (depends on 18) The bodily-fluid transfer device of claim 18, wherein the seal member is configured to form a substantially fluid tight seal with at least a portion of an inner surface of the housing. ### Claim 20 (depends on 18) The bodily-fluid transfer device of claim 18, wherein the seal member defines a fluidic seal with inner walls of the housing to at least partially define the fluid reservoir such that the first amount of the bodily-fluid is contained therein. ### Claim 21 (depends on 18) The bodily-fluid transfer device of claim 18, wherein the first amount of the bodily-fluid is less than approximately 5 ml. ### Claim 22 (depends on 18) The bodily-fluid transfer device of claim 18, wherein the first amount of the bodily-fluid is at least a volume of a lumen of a lumen-containing device fluidically coupled to the inlet port. ### Claim 23 (depends on 18) The bodily-fluid transfer device of claim 18, wherein the outlet port is fluidically isolated from the fluid reservoir when the flow controller is in the second configuration. ### Claim 24 (depends on 18) The bodily-fluid transfer device of claim 18, wherein the seal member allows a negative pressure differential to form in the fluid reservoir such that the first amount of the bodily-fluid flows from the inlet port and into the fluid reservoir. ### Claim 25 (depends on 18) The bodily-fluid transfer device of claim 18, wherein the flow controller is configured to transition from the first configuration to the second configuration only after the first amount of the bodily-fluid is at least partially disposed in the fluid reservoir.