# US 2014/0155782 A1 · Sterile bodily-fluid collection device and methods

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- Number: US 2014/0155782 A1
- Document ID: US20140155782A1
- Status: Published application
- Kind: A1
- Application number: 14/096,826
- Filed: 2013-12-04
- Published: 2014-06-05
- Earliest claimed: 2012-12-04
- Assignees: Magnolia Medical Technologies, Inc.
- Applicants: Magnolia Medical Technologies, Inc.
- Inventors: Gregory J. Bullington; Richard G. Patton; Shan E. Gaw
- Web page: https://patentgrep.com/patent/US20140155782A1

## CPC

- A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood
- A61B 5/150221: {Valves}
- 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 5/154: {Devices} using pre-evacuated means
- A61B 10/0045: {Devices for taking samples of body liquids}
- A61B 5/15003: {for venous or arterial blood}
- A61B 5/155: {Devices} specially adapted for continuous or multiple sampling, e.g. at predetermined intervals {(devices loaded with multiple lancets simultaneously A61B5/15146)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An apparatus includes a pre-sample reservoir, a diversion mechanism, and a flow metering mechanism. The diversion mechanism has an inlet port couplable to a lumen-defining device to receive bodily-fluids from a patient, a first outlet port fluidically couplable to the pre-sample reservoir, and a second outlet port fluidically couplable to a sample reservoir. The diversion mechanism defines a first fluid flow path and a second flow path that are configured to place the first outlet port and the second outlet port, respectively, in fluid communication with the inlet port. The flow metering mechanism is configured to meter a flow of a predetermined volume of bodily-fluid through the first fluid flow path into the pre-sample reservoir, to meter a flow of a second volume of bodily-fluid through the second fluid flow path into the sample reservoir, and to display a volumetric indicator associated with the predetermined volume and the second volume.

## Claims

### Claim 1

An apparatus for obtaining a bodily fluid sample from a patient, the apparatus comprising:
a pre-sample reservoir configured to receive a first volume of bodily-fluid withdrawn from the patient;
a diversion mechanism including an inlet port, a first outlet port, and a second outlet port, the inlet port configured to be coupled to a lumen-defining device for receiving bodily-fluids from the patient, the first outlet port configured to fluidically couple the pre-sample reservoir to the diversion mechanism and the second outlet port configured to fluidically couple a sample reservoir to the diversion mechanism, the diversion mechanism defining a first fluid flow path configured to place the first outlet port in fluid communication with the inlet port and a second fluid flow path configured to place the second outlet port in fluid communication with the inlet port; and
a flow metering mechanism in fluid communication with the first fluid flow path and the second fluid flow path, the flow metering mechanism configured to meter a flow of the first volume of bodily-fluid through the first fluid flow path into the pre-sample reservoir and to meter a flow of a second volume of bodily-fluid through the second fluid flow path into the sample reservoir, the flow metering mechanism configured to display a volumetric indicator associated with the first volume and the second volume.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the first volume of bodily-fluid flows within the first fluid flow path during a first time period and the second volume of bodily-fluid flows within the second fluid flow path during a second time period, after the first time period.

### Claim 3

(canceled)

### Claim 4

(canceled)

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the volumetric indicator is a visual indicator.

### Claim 6 (depends on 1)

The apparatus of claim 1, wherein the diversion mechanism includes a movable member configured to move through the second outlet port to place the sample reservoir in fluid communication with the second fluid flow path.

### Claim 7 (depends on 6)

The apparatus of claim 6, wherein the flow metering mechanism is at least partially disposed within a portion of the movable member.

### Claim 8

(canceled)

### Claim 9 (depends on 1)

The apparatus of claim 1, wherein the diversion mechanism includes a third outlet port configured to fluidically couple a second sample reservoir to the diversion mechanism and defines a third fluid flow path configured to place the third out port in fluid communication with the inlet port.

### Claim 10 (depends on 1)

The apparatus of claim 1, further comprising:
a flow controller defining a first lumen and a second lumen, the flow controller configured to be moved between a first configuration in which the first lumen places the first fluid flow path in fluid communication with the inlet port and a second configuration in which the second lumen places the second fluid flow path in fluid communication with the inlet port.

### Claim 11 (depends on 10)

The apparatus of claim 10, wherein the flow controller is configured to be moved from the first configuration to the second configuration after the first volume of bodily-fluid is disposed in the pre-sample reservoir.

### Claim 12

An apparatus for obtaining a bodily-fluid sample from a patient, the apparatus comprising:
a pre-sample reservoir configured to receive a first volume of bodily-fluid withdrawn from the patient;
a diversion mechanism including an inlet port, a first outlet port, and a second outlet port, the inlet port configured to be coupled to a lumen-defining device for receiving bodily-fluids from the patient, the first outlet port configured to fluidically couple the pre-sample reservoir to the diversion mechanism and the second outlet port configured to fluidically couple a sample reservoir to the diversion mechanism;
a flow controller at least partially disposed within the diversion mechanism and configured to be moved between a first configuration in which the flow controller defines at least a portion of a fluid flow path between the inlet port and the first outlet port, and a second configuration in which the flow controller defines at least a portion of a fluid flow path between the inlet port and the second outlet port; and
a movable member movably coupled to the diversion mechanism and configured to be moved through the second outlet port between a first configuration in which the sample reservoir is fluidically isolated from the fluid flow path between the inlet port and the second outlet port, and a second configuration in which the sample reservoir is in fluid communication with the fluid flow path between the inlet port and the second outlet port, the sample reservoir configured to receive a second volume of bodily-fluid withdrawn from the patient when the flow controller is in its second configuration and the movable member is in its second configuration.

### Claim 13

(canceled)

### Claim 14 (depends on 12)

The apparatus of claim 12, wherein the flow controller is rotated relative to the diversion mechanism between its first configuration and its second configuration.

### Claim 15 (depends on 12)

The apparatus of claim 12, wherein the flow controller is moved in a linear motion relative to the diversion mechanism.

### Claim 16

(canceled)

### Claim 17 (depends on 12)

The apparatus of claim 12, wherein the movable member includes a piercing member configured to pierce a portion of the sample reservoir when the movable member is in its second configuration.

### Claim 18 (depends on 12)

The apparatus of claim 12, wherein the movable member is coupled to a bias member configured to at least temporarily maintain the movable member in its first configuration.

### Claim 19

(canceled)

### Claim 20

(canceled)

### Claim 21

An apparatus for obtaining a bodily-fluid sample from a patient, the apparatus comprising:
a pre-sample reservoir configured to receive a first volume of bodily-fluid withdrawn from the patient;
a diversion mechanism including a housing and a distribution member, the housing defining a first aperture and a second aperture, the first aperture is in fluid communication with the pre-sample reservoir, the distribution member is at least partially disposed within the housing and defines a fluid flow channel in fluid communication with the second aperture, the distribution member includes a coupling portion in fluid communication with the flow channel and configured to be physically and fluidically coupled to a sample reservoir; and
a flow controller including an inlet port configured to be coupled to a lumen-defining device for receiving bodily-fluids from the patient, the flow controller rotatably coupled to the diversion mechanism and configured to be moved between a first configuration in which the inlet port is in fluid communication with the first aperture, and a second configuration in which the inlet port is in fluid communication with the second aperture.

### Claim 22

(canceled)

### Claim 23

(canceled)

### Claim 24 (depends on 21)

The apparatus of claim 21, wherein the coupling portion includes a piercing member configured to pierce a portion of the sample reservoir to place the sample reservoir in fluid communication with the fluid flow channel.

### Claim 25 (depends on 24)

The apparatus of claim 24, wherein the piercing of the portion of the sample reservoir by the piercing member initiates a flow of bodily-fluid from the patient, through the inlet port and the flow channel, and into the sample reservoir when the flow controller is in its second configuration.

### Claim 26 (depends on 21)

The apparatus of claim 21, wherein the first volume of bodily-fluid is a first predetermined volume of bodily-fluid, the fluid flow channel is configured to receive a second predetermined volume of bodily-fluid, the second predetermined volume of bodily-fluid associated with a sample volume.

### Claim 27 (depends on 26)

The apparatus of claim 26, wherein the sample volume is between about 10 milliliters and about 50 milliliters.

### Claim 28 (depends on 26)

The apparatus of claim 26, wherein the sample volume is about 30 milliliters.

### Claim 29 (depends on 21)

The apparatus of claim 21, wherein the diversion mechanism includes a seal member disposed between the housing and the flow controller when the flow controller is coupled to the diversion mechanism such that the seal member forms a substantially fluid tight seal with a surface of the flow controller and a surface of the housing, the seal member defining a first aperture and a second aperture, the first aperture of the seal member being substantially coaxial with the first aperture of the housing, and the second aperture of the seal member being substantially coaxial with the second aperture of the housing.

### Claim at position 30

30-41. (canceled)