# US 9,517,026 B2 · Biological fluid collection device and biological fluid separation and testing system

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- Number: US 9,517,026 B2
- Document ID: US9517026B2
- Status: Granted
- Kind: B2
- Application number: 14/251,676
- Filed: 2014-04-14
- Published: 2014-10-16
- Granted: 2016-12-13
- Earliest claimed: 2013-04-15
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Craig A. Gelfand; Ashley Rachel Rothenberg; Bradley M. Wilkinson; Daniel J. Marchiarullo
- Web page: https://patentgrep.com/patent/US9517026B2

## CPC

- A61B 5/150267: {Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules}
- A61B 5/1411: {by percutaneous method, e.g. by lancet}
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150213: {Venting means}
- A61B 5/150221: {Valves}
- A61B 5/150305: {Packages specially adapted for piercing devices or blood sampling devices}
- A61B 5/150343: {Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes (sampling from within body cavities A61B5/150015, A61B5/150045)}
- 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 5/150412: {Pointed piercing elements, e.g. needles, lancets for piercing the skin (blade-like piercing elements A61B5/150442)}
- A61B 5/150442: {Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin}
- A61B 5/150748: {Having means for aiding positioning of the piercing device at a location where the body is to be pierced (means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489)}
- A61B 5/150755: {Blood sample preparation for further analysis, e.g. by separating blood components or by mixing}
- A61B 5/150778: {having complementary physical shapes for indexing or registration purposes}
- A61B 5/151: {Devices} specially adapted for taking samples of capillary blood, e.g. by lancets {, needles or blades}
- A61B 5/15101: {Details}
- A61B 5/15105: {Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices}
- A61B 5/15144: {comprising driving means, e.g. a spring, for retracting the piercing unit into the housing}
- A61B 5/15198: {purely manually retracted}
- A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood
- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/3406: {Physical characteristics of the filtrate, e.g. urea}
- A61M 1/36: Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation {; Extra-corporeal blood circuits}
- B01L 3/502: {with fluid transport, e.g. in multi-compartment structures}
- B01L 3/5021: {Test tubes specially adapted for centrifugation purposes}
- B01L 3/50273: {characterised by the means or forces applied to move the fluids}
- B04B 7/08: Rotary bowls (centrifugal casting machines B22D)
- G01N 1/28: Preparing specimens for investigation {including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q}(mounting specimens on microscopic slides G02B21/34; means for supporting the objects or the materials to be analysed in electron microscopes H01J37/20 {; laboratory gas handling apparatus B01L5/00})
- G01N 1/34: Purifying; Cleaning {(processes or apparatus for extracting or separating nucleic acids from biological samples C12N15/1003)}
- G01N 1/4005: {by transferring a selected component through a membrane}
- G01N 1/4077: {by other techniques involving separation of suspended solids}
- G01N 33/491: {by separating the blood components (G01N15/05 takes precedence)}
- A61B 5/150435: {Specific design of proximal end}
- A61B 5/150969: {Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing}
- B01L 2200/027: for microfluidic devices
- B01L 2200/0621: Control of the sequence of chambers filled or emptied
- B01L 2200/0631: Purification arrangements, e.g. solid phase extraction [SPE]
- B01L 2200/0684: Venting, avoiding backpressure, avoid gas bubbles
- B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
- B01L 2300/0627: Sensor or part of a sensor is integrated
- B01L 2300/0672: Integrated piercing tool
- B01L 2300/0681: Filter
- B01L 2300/0803: Disc shape
- B01L 2300/0864: comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
- B01L 2300/0877: Flow chambers
- B01L 2400/0406: capillary forces
- B01L 2400/0409: centrifugal forces
- B01L 2400/0478: pistons
- B01L 2400/0688: surface tension valves, capillary stop, capillary break
- G01N 2001/4016: {being a selective membrane, e.g. dialysis or osmosis}
- G01N 2001/4088: {filtration}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)}
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B04B: CENTRIFUGES (high-speed drum mills B02C19/11; domestic spin driers D06F; analysing, measuring or monitoring physical or chemical properties of samples during centrifuging, see the relevant subclasses for these procedures, e.g. G01N)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A biological fluid collection device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. After collecting the blood sample, the biological fluid collection device is able to transfer the blood sample to a point-of-care testing device or a biological fluid separation and testing device. After transferring the blood sample, the biological fluid separation and testing device is able to separate the plasma portion from the cellular portion and analyze the blood sample and obtain test results.

## Claims

### Claim 1

A biological fluid separation and testing system for a multi-component blood sample, comprising:
a biological fluid collection device, comprising:
a lancet housing having an inlet port and an interior defining a first flow channel in fluid communication with the inlet port and a second flow channel in fluid communication with the first flow channel, wherein at least a portion of the second flow channel is diverted from the first flow channel;
a puncturing element moveable between a pre-actuated position wherein the puncturing element is retained within the interior of the housing and a puncturing position wherein the puncturing element extends through the inlet port of the housing and provides fluid communication with the first flow channel; and
a transfer cartridge having a reservoir, wherein the second flow channel is in fluid communication with the reservoir of the transfer cartridge; and
a biological fluid separation device, comprising:
a rotatable body having a center of rotation and an outer periphery, the rotatable body having a body inlet adapted to receive the multi-component blood sample;
a separation chamber defined within the rotatable body and in fluid communication with the body inlet and having a chamber outlet spaced apart from the body inlet, the separation chamber adapted to receive the multi-component blood sample therein; and
a blood component chamber defined within the rotatable body and in fluid communication with the chamber outlet, wherein when the separation chamber contains the multi-component blood sample and a rotational force is applied to the rotatable body, a blood component of the multi-component blood sample passes from the separation chamber into the blood component chamber and a second component of the multi-component blood sample is retained within the separation chamber,
wherein the blood component chamber is disposed adjacent the center of rotation and the separation chamber is disposed adjacent the outer periphery of the rotatable body, and
wherein the body inlet is engagable with the reservoir of the transfer cartridge for transferring the multi-component blood sample from the reservoir of the transfer cartridge to the biological fluid separation device.

### Claim 2 (depends on 1)

The biological fluid separation and testing system of claim 1, wherein a portion of the rotatable body is threadably engageable with a portion of the transfer cartridge for aligning the body inlet in fluid communication with the reservoir.

### Claim 3 (depends on 1)

The biological fluid separation and testing system of claim 1, wherein the first flow channel is dimensioned to receive the first blood provided to the flow channel.

### Claim 4 (depends on 1)

The biological fluid separation and testing system of claim 1, wherein the transfer cartridge is removably engageable with a portion of the housing and subsequently engageable with a portion of the rotatable body.

### Claim 5 (depends on 1)

The biological fluid separation and testing system of claim 1, wherein at least one of the first flow channel and the second flow channel includes a vent to atmosphere.

### Claim 6 (depends on 1)

The biological fluid separation and testing system of claim 1, further comprising a diagnostic chamber in fluid communication with the blood component chamber.

### Claim 7 (depends on 1)

The biological fluid separation and testing system of claim 1, wherein the blood component is a plasma component of the multi-component blood sample and the second component is a cellular component of the multi-component blood sample.

### Claim 8 (depends on 1)

The biological fluid separation and testing system of claim 1, wherein the blood component chamber receives the blood component of the multi-component blood sample upon the rotatable body being rotated by a processing instrument.

### Claim 9 (depends on 1)

The biological fluid separation and testing system of claim 1, further comprising a diagnostic chamber in fluid communication with the blood component and including a detection zone readable by a processing instrument.