Fluid diversion mechanism for bodily-fluid sampling

A method for procuring bodily-fluid samples from a patient using a parenteral sampling device, the device including a housing having an inlet port configured to be fluidically coupled to the patient and an outlet port configured to be fluidically coupled to a sample reservoir, a fluid reservoir, a diverter, a flow control mechanism disposed in the diverter and defining a first fluid flow path and a second fluid flow path, and an actuator operably coupled to the diverter, the method comprising:

• establishing fluid communication between the patient and the inlet port;
• transitioning the flow control mechanism from a third configuration, in which the first fluid flow path and the second fluid flow path are fluidically isolated from the inlet port, to a first configuration, in which the first fluid flow path places the inlet port in fluid communication with the fluid reservoir;
• moving the actuator a first distance relative to the housing to move a seal member from a first position toward a second position to create a suction force in the fluid reservoir operable to draw a first volume of bodily-fluid from the patient through the inlet port and the first fluid flow path into the fluid reservoir;
• moving the actuator a second distance relative to the housing to place the seal member in the second position after the first volume of bodily-fluid has been received in the fluid reservoir, the diverter being moved with the actuator to place a portion of the flow control mechanism in contact with a portion of the housing, the flow control mechanism being transitioned from the first configuration to a second configuration, in which bodily-fluid is allowed to flow from the patient to the outlet port when the portion of the flow control mechanism is placed in contact with the portion of the housing;
• coupling the outlet port to a sample reservoir, the sample reservoir having a negative pressure that produces a suction force in at least the second fluid flow path operable to draw bodily-fluid from the patient to the sample reservoir when the flow control mechanism is placed in the second configuration;
• and
• at least partially obstructing the second fluid flow path when the flow control mechanism is in the second configuration to reduce the suction force in at least a portion of the second fluid flow path.

A method for procuring bodily-fluid samples using a parenteral sampling device, the device including a needle having a lumen configured for insertion into the patient, and a fluid reservoir fluidically coupleable to the needle, the method comprising:

• inserting the needle of the device into the patient;
• establishing fluid communication between the needle and the fluid reservoir;
• moving an actuator a first distance to create a negative pressure in the fluid reservoir and to withdraw a predetermined volume of bodily-fluid;
• moving the actuator a second distance to engage a flow control mechanism and rotate the flow control mechanism from a first configuration to a second configuration, the first configuration operable to allow bodily-fluid to flow through a first flow path from the needle to the fluid reservoir, the second configuration operable to allow bodily-fluid to flow through a second flow path from the needle to an outlet port;
• coupling the outlet port to a sample reservoir and allowing bodily-fluid to flow through the second flow path from the needle, through the outlet port, and to the sample reservoir, the sample reservoir having a negative pressure that produces a suction force in at least the second fluid flow path operable to draw bodily-fluid from the patient to the sample reservoir when the flow control mechanism is placed in the second configuration;
• and
• at least partially obstructing the second fluid flow path when the flow control mechanism is in the second configuration to reduce the suction force in at least a portion of the second fluid flow path.

A method for procuring bodily-fluid samples using a parenteral sampling device, the device including a needle having a lumen configured for insertion into a patient, and a fluid reservoir fluidically coupleable to the needle, the method comprising:

• inserting the needle of the device into the patient;
• establishing fluid communication between the needle and the fluid reservoir;
• applying a first activation force to an actuator to create a negative pressure in the fluid reservoir and to withdraw a predetermined volume of bodily-fluid from the patient;
• reducing the first activation force applied to the actuator to reduce the negative pressure created in the fluid reservoir;
• applying a second activation force to the actuator to engage a flow control mechanism and move the flow control mechanism from a first configuration to a second configuration, the first configuration operable to allow bodily-fluid to flow through a first flow path from the needle to the fluid reservoir, the second configuration operable to allow bodily-fluid to flow through a second flow path from the needle to an outlet port;
• coupling the outlet port to a sample reservoir and allowing bodily-fluid to flow through the second flow path from the needle, through the outlet port, and to the sample reservoir, the sample reservoir having a negative pressure that produces a suction force in at least the second fluid flow path operable to draw bodily-fluid from the patient to the sample reservoir when the flow control mechanism is placed in the second configuration;
• and
• at least partially obstructing the second fluid flow path when the flow control mechanism is in the second configuration to reduce the suction force in at least a portion of the second fluid flow path.

A method for procuring bodily-fluid samples from a patient using a parenteral sampling device, the device including an inlet port configured to be placed in fluid communication with the patient, an actuator including a seal member defining a portion of a fluid reservoir, and a flow control mechanism configured to selectively place the fluid reservoir in fluid communication with the patient, the method comprising:

• establishing fluid communication between the patient and the inlet port;
• disposing the flow control mechanism in a first configuration, the flow control mechanism defining a first fluid flow path configured to place the inlet port in fluid communication with the fluid reservoir;
• exerting an activation force on a portion of the actuator to move the seal member from a first position, in which the fluid reservoir has a first volume, toward a second position, in which the fluid reservoir has a second volume greater than the first volume, an increase in volume producing a negative pressure differential in the fluid reservoir operable to draw a predetermined volume of bodily-fluid into the fluid reservoir;
• modulating the activation force exerted on the portion of the actuator to modulate the negative pressure differential in the fluid reservoir, the actuator operably coupled to a bias member configured to exert a reaction force in response to the activation force to reduce a magnitude of the activation force exerted on the portion of the actuator a sufficient amount such that the reaction force exerted by the bias member moves the seal member toward the first position;
• and
• transitioning the flow control mechanism from the first configuration to a second configuration in response to the seal member being placed in the second position, the flow control mechanism operable to allow bodily-fluid to flow through a second fluid flow path from the inlet port to an outlet port when the flow control mechanism is in the second configuration.