# US 11,298,060 B2 · Devices for collecting biological samples > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,298,060 B2 - Document ID: US11298060B2 - Status: Granted - Kind: B2 - Application number: 16/685,954 - Filed: 2019-11-15 - Published: 2020-05-28 - Granted: 2022-04-12 - Earliest claimed: 2017-01-10 - Assignees: Drawbridge Health, Inc. - Applicants: Drawbridge Health, Inc. - Inventors: Brett L. Jordan; Masao Drexel; Dagmar Beyerlein; Alicia Jackson; Kara Juneau - Web page: https://patentgrep.com/patent/US11298060B2 ## CPC - 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 5/150022: {for capillary blood or interstitial fluid} - A61B 5/15016: {by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element} - 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 5/150267: {Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules} - A61B 5/150305: {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 5/150427: {Specific tip design, e.g. for improved penetration characteristics} - A61B 5/150442: {Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin} - A61B 5/150977: {Arrays of piercing elements for simultaneous piercing} - A61B 5/150984: {Microneedles or microblades} - A61B 5/15113: {Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button} - A61B 5/15117: {comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap} - A61B 5/15142: {Devices intended for single use, i.e. disposable} - B01L 3/0296: {from piercable tubing, e.g. in extracorporeal blood sampling} - B01L 3/5023: {with a sample being transported to, and subsequently stored in an absorbent for analysis} - B01L 3/508: {Rigid containers without fluid transport within} - G01N 33/487: of liquid biological material - G01N 35/00732: {Identification of carriers, materials or components in automatic analysers} - 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 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)} - A61B 5/150969: {Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing} - A61B 5/1513: {comprising linear sliding guides (comprising tooth-shaped elements A61B5/15132)} - B01L 2200/026: Fluid interfacing between devices or objects, e.g. connectors, inlet details - B01L 2200/18: Transport of container or devices - B01L 2300/021: Identification, e.g. bar codes - B01L 2300/041: Connecting closures to device or container - B01L 2300/06: Auxiliary integrated devices, integrated components - B01L 2300/0609: Holders integrated in container to position an object - B01L 2300/0825: Test strips - B01L 2300/0864: comprising only one inlet and multiple receiving wells, e.g. for separation, splitting - B01L 2400/0406: capillary forces - B01L 2400/049: vacuum - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - 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 Disclosed herein are devices, apparatus, systems, methods and kits for collecting and storing a fluid sample from a subject. A device for collecting the fluid sample can include a housing comprising a recess having an opening, a vacuum chamber in the housing and in fluidic communication with the recess, and one or more piercing elements that are extendable through the opening to penetrate skin of the subject. The vacuum chamber can be configured for having a vacuum that draws the skin into the recess. The recess can be configured having a size or shape that enables an increased volume of the fluid sample to be accumulated in the skin drawn into the recess. ## Claims ### Claim 1 A handheld device for collecting a blood sample from a subject, the handheld device comprising: a housing comprising a base surface configured to be placed onto a skin of the subject; an interface on the housing, wherein the interface is configured to be moved in a first direction in order to activate one or more piercing elements that are extendable through an opening of the housing in a second direction to penetrate the skin of the subject to enable collection of the blood sample into a cartridge coupled to the housing while the skin is drawn into a recess located on the base surface of the housing, the first direction being different from the second direction; a vacuum chamber in the housing; and another interface on the housing, wherein the another interface is configured to activate the vacuum chamber and cause the skin to be drawn into the recess of the housing, wherein the interface is configured to be initially in a locked state that prevents activation of the one or more piercing elements prior to activation of the vacuum chamber by the another interface, wherein the housing further comprises a window that permits observation of a progress of a collection of the blood sample as the blood sample flows into and is collected in the cartridge. ### Claim 2 (depends on 1) The handheld device of claim 1, further comprising one or more matrices on which the blood sample is collected. ### Claim 3 (depends on 1) The handheld device of claim 1, wherein the first direction and the second direction are non-parallel to each other. ### Claim 4 (depends on 3) The handheld device of claim 3, wherein the first direction and the second direction are substantially orthogonal to each other. ### Claim 5 (depends on 1) The handheld device of claim 1, wherein the first direction is non-orthogonal to a planar portion of the base surface. ### Claim 6 (depends on 5) The handheld device of claim 5, wherein the first direction is substantially parallel to the planar portion of the base surface. ### Claim 7 (depends on 5) The handheld device of claim 5, wherein the recess is surrounded by the planar portion of the base surface. ### Claim 8 (depends on 1) The handheld device of claim 1, wherein the interface is located on a side surface of the housing that is non-parallel to the base surface. ### Claim 9 (depends on 1) The handheld device of claim 1, wherein the interface is configured to be moved in the first direction to aid in reducing a pain perception level of the subject when the one or more piercing elements are activated to penetrate the skin of the subject. ### Claim 10 (depends on 1) The handheld device of claim 1, wherein the device is configured for use on an upper extremity of the subject. ### Claim 11 (depends on 1) The handheld device of claim 1, wherein the interface is operably coupled to a piercing activator located within the housing, and the piercing activator is configured to activate the one or more piercing elements when the interface is moved. ### Claim 12 (depends on 1) The handheld device of claim 1, wherein the one or more piercing elements are configured to travel through the housing and extend out from the opening of the housing in the second direction. ### Claim 13 (depends on 11) The handheld device of claim 11, wherein the piercing activator comprises one or more spring elements. ### Claim 14 (depends on 13) The handheld device of claim 13, wherein the one or more spring elements comprises a deployment spring configured to extend the one or more piercing elements through the opening of the house to penetrate the skin of the subject. ### Claim 15 (depends on 1) The handheld device of claim 1, wherein the device further comprises a retraction spring configured to retract the one or more piercing elements through the opening of the housing after the skin of the subject has been penetrated. ### Claim 16 (depends on 1) The handheld device of claim 1, wherein the another interface is operably coupled to a vacuum activator located within the housing, wherein the vacuum activator is configured to activate the vacuum chamber when the another interface is moved. ### Claim 17 (depends on 1) The handheld device of claim 1, wherein the interface and the another interface are configured to be moved in a same direction. ### Claim 18 (depends on 1) The handheld device of claim 1, wherein the interface is configured to be moved along a first axis, and the another interface is configured to be moved along a second axis that is different from the first axis. ### Claim 19 (depends on 18) The handheld device of claim 18, wherein the first axis and the second axis are substantially parallel to each other. ### Claim 20 (depends on 1) The handheld device of claim 1, wherein the interface and the another interface are located on a same side surface of the housing. ### Claim 21 (depends on 1) The handheld device of claim 1, wherein the interface is located further away from the base surface of the housing than the another interface. ### Claim 22 (depends on 1) The handheld device of claim 1, wherein the housing comprises a housing base and a housing cover coupled to each other. ### Claim 23 (depends on 22) The handheld device of claim 22, wherein the vacuum chamber is located in the housing base, and the another interface is located on a side surface of the housing base. ### Claim 24 (depends on 22) The handheld device of claim 22, wherein the piercing activator is located in the housing cover, and the interface is located on a side surface of the housing cover. ### Claim 25 (depends on 22) The handheld device of claim 22, wherein the housing base is located between the skin of the subject and the housing cover when the base surface is in contact with the skin of the subject. ### Claim 26 (depends on 22) The handheld device of claim 22, wherein the housing base comprises the base surface. ### Claim 27 (depends on 1) The handheld device of claim 1, wherein the interface is configured to be unlocked and becomes movable after the another interface has been moved. ### Claim 28 (depends on 1) The handheld device of claim 1, wherein the interface is configured to be unlocked so as to enable the one or more piercing elements to be activated, after the vacuum chamber has been activated by moving the another interface. ### Claim 29 (depends on 1) The handheld device of claim 1, wherein the housing comprises a cartridge chamber configured to receive the cartridge, wherein the window is substantially parallel to a longitudinal axis of the cartridge chamber. ### Claim 30 (depends on 1) The handheld device of claim 1, wherein the interface comprises a locking mechanism coupled to the another interface, such that the interface is initially in the locked state. ### Claim 31 (depends on 1) The handheld device of claim 1, wherein the another interface serves as a key for unlocking the interface, and wherein the interface is unlocked when the another interface is activated.