# US 10,441,205 B2 · Multi-site body fluid sampling and analysis cartridge

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,441,205 B2
- Document ID: US10441205B2
- Status: Granted
- Kind: B2
- Application number: 15/191,434
- Filed: 2016-06-23
- Published: 2016-12-22
- Granted: 2019-10-15
- Earliest claimed: 2005-09-30
- Assignees: Intuity Medical, Inc.
- Applicants: Intuity Medical, Inc.
- Inventors: Craig M. Litherland; Jeffrey L. Emery; Raul Escutia; James W. Pfeiffer; Jeffrey M. Jones
- Web page: https://patentgrep.com/patent/US10441205B2

## CPC

- A61B 5/150984: {Microneedles or microblades}
- A61B 5/1411: {by percutaneous method, e.g. by lancet}
- A61B 5/1427: {Multiple blood sampling, e.g. at periodic or pre-established intervals}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/1468: using chemical or electrochemical methods, e.g. by polarographic means
- A61B 5/1486: using enzyme electrodes, e.g. with immobilised oxidase
- A61B 5/150022: {for capillary blood or interstitial fluid}
- A61B 5/150068: {by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced}
- A61B 5/150076: {by heating}
- A61B 5/150083: {by vibration, e.g. ultrasound}
- 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 5/150167: {Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive}
- A61B 5/150229: {Pumps for assisting the blood sampling}
- 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 5/150389: {Hollow piercing elements, e.g. canulas, needles, for piercing the skin}
- A61B 5/150396: {Specific tip design, e.g. for improved penetration characteristics}
- A61B 5/150412: {Pointed piercing elements, e.g. needles, lancets for piercing the skin (blade-like piercing elements A61B5/150442)}
- A61B 5/150946: {Means for varying, regulating, indicating or limiting the speed or time of blood collection}
- A61B 5/150954: {Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor}
- A61B 5/151: {Devices} specially adapted for taking samples of capillary blood, e.g. by lancets {, needles or blades}
- A61B 5/15111: {Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user}
- 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 5/15121: {comprising piezos}
- A61B 5/15123: {comprising magnets or solenoids}
- A61B 5/15146: {Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. (multiple simultaneous cutting or piercing A61B5/150977)}
- A61B 5/15148: {Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube}
- A61B 5/15151: {Each piercing element being stocked in a separate isolated compartment}
- A61B 5/15161: {Characterized by propelling the piercing element in a radial direction relative to the disc}
- A61B 5/15163: {Characterized by propelling the piercing element in an axial direction relative to the disc}
- A61B 5/15186: {Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use}
- 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 5/157: {Devices} characterised by integrated means for measuring characteristics of blood
- A61B 5/681: {Wristwatch-type devices}
- A61B 5/6824: {Arm or wrist}
- A61B 5/6828: {Leg}
- G01N 1/14: Suction devices, e.g. pumps; Ejector devices
- G01N 21/0303: {Optical path conditioning in cuvettes, e.g. windows; adapted optical elements or systems; path modifying or adjustment (G01N21/031 - G01N21/15 take precedence)}
- G01N 21/77: by observing the effect on a chemical indicator
- G01N 27/416: Systems (G01N27/27 takes precedence)
- A61B 5/150969: {Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing}
- A61B 2560/0443: Modular apparatus
- A61B 2560/0462: Apparatus with built-in sensors
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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

An arrangement includes a housing, a plurality of sampling and analysis sites contained within the housing, each of the sampling and analysis sites having a skin-penetration member having a first end configured to pierce the skin, and an inner lumen in communication with the first end, an actuator operatively associated with the skin-penetration member, and an analyte quantification member in fluid communication with the inner lumen of the skin-penetration member. Integrated devices including such arrangements are also described.

## Claims

### Claim 1

An arrangement comprising:
a housing comprising a plurality of chambers;
a plurality of sampling and analysis sites, each of the plurality of sampling and analysis sites contained within a respective chamber of the housing and comprising:
a skin-penetration member having a first end configured to pierce skin, wherein the skin-penetration member comprises an inner lumen in communication with the first end;
an actuator configured to drive the skin penetration member; and
an analyte quantification member in fluid communication with the inner lumen of the skin-penetration member; and
at least one seal configured to protect the skin-penetration member, actuator, and analyte quantification member from contamination, wherein each chamber is enclosed and completely sealed.

### Claim 2 (depends on 1)

The arrangement of claim 1, wherein the housing comprises an inner frame.

### Claim 3 (depends on 2)

The arrangement of claim 2, wherein the inner frame partially encloses each of the plurality of chambers.

### Claim 4 (depends on 1)

The arrangement of claim 1, wherein the housing comprises an opening for passage of one of the plurality of skin-penetration members and the at least one seal covers the opening.

### Claim 5 (depends on 4)

The arrangement of claim 4, wherein the at least one seal is puncturable.

### Claim 6 (depends on 5)

The arrangement of claim 5, wherein one of the skin-penetration members punctures the at least one seal.

### Claim 7 (depends on 4)

The arrangement of claim 4, wherein the at least one seal is removeable.

### Claim 8 (depends on 1)

The arrangement of claim 1, wherein the housing comprises an opening for passage of a triggering mechanism configured to trigger at least one of the sampling and analysis sites, and wherein the at least one seal covers the opening.

### Claim 9 (depends on 8)

The arrangement of claim 8, wherein the at least seal comprises:
a solid flexible membrane;
an aperture membrane in combination with a secondary seal; or
a pierceable membrane.

### Claim 10 (depends on 8)

The arrangement of claim 8, wherein the at least one seal is configured to maintain sealing after passage of the triggering mechanism therethrough.

### Claim 11 (depends on 1)

The arrangement of claim 1, wherein the housing comprises a first opening for passage of one of the plurality of skin-penetration members and a second opening for passage of a triggering mechanism.

### Claim 12 (depends on 11)

The arrangement of claim 11, wherein the at least one seal comprises a first seal covering the first opening and a second seal covering the second opening.

### Claim 13 (depends on 1)

The arrangement of claim 1, wherein the housing comprises a plurality of openings positioned to correspond with the location of the plurality of skin penetration members, and wherein the at least one seal covers the openings.

### Claim 14 (depends on 13)

The arrangement of claim 13, wherein the at least one seal comprises a sealing film.

### Claim 15 (depends on 1)

The arrangement of claim 1, wherein at least one of the plurality of skin-penetration members comprises a needle.

### Claim 16 (depends on 1)

The arrangement of claim 1, wherein at least one of the plurality of actuators comprises a spring.

### Claim 17 (depends on 16)

The arrangement of claim 16, wherein the spring comprises a torsional spring configured to urge at least one of the skin-penetration members along an arcuate path.

### Claim 18 (depends on 17)

The arrangement of claim 17, wherein the at least one skin-penetration member of the at least one sampling and analysis site that comprises the torsional spring is configured to obstruct a wound opening in skin of a user after the torsional spring moves to a neutral position.

### Claim 19 (depends on 1)

The arrangement of claim 1, wherein each analysis site further comprises a hub and each skin-penetration member is attached to a respective hub.

### Claim 20 (depends on 19)

The arrangement of claim 19, wherein at least one of the hubs is configured to be released by a triggering mechanism, and wherein the respective actuator is configured to move the hub when the hub is released.

### Claim 21 (depends on 1)

An integrated body fluid sampling and analysis device comprising the arrangement of claim 1.

### Claim 22 (depends on 21)

The integrated device of claim 21 further comprising a detector in optical communication with at least one analyte quantification member through a transparent portion of the housing.

### Claim 23 (depends on 22)

The integrated device of claim 22, wherein the detector comprises at least one complementary metal oxide semiconductor (CMOS)-based detector element.

### Claim 24 (depends on 22)

The integrated device of claim 22, wherein the detector comprises at least one of a linear or area array of CMOS-based detector elements.

### Claim 25 (depends on 21)

The integrated device of claim 21, wherein the arrangement is provided as a disposable cartridge.

### Claim 26 (depends on 21)

The integrated device of claim 21, wherein the integrated device moves the housing in order to present a new sampling and analysis site for use after the performance of a preceding sampling and analysis event.

### Claim 27 (depends on 21)

The integrated device of claim 21 further comprising at least one light source and detector, wherein the at least one light source and detector are configured to interrogate each analyte quantification member.

### Claim 28 (depends on 27)

The integrated device of claim 27, wherein the analyte quantification members are moveable to index and come into registry with the at least one light source and detector for analysis.

### Claim 29 (depends on 27)

The integrated device of claim 27, wherein the at least one light source and detector are configured to move to facilitate the creation of a list of unused analyte quantification members or to align an analyte quantification member with the at least one light source and detector for analysis.

### Claim 30 (depends on 21)

The integrated device of claim 21, wherein the integrated device is configured for one or more of hand-held operation and operation while being worn.

### Claim 31 (depends on 1)

The arrangement of claim 1, wherein the arrangement is provided as a disposable cartridge.

### Claim 32 (depends on 1)

The arrangement of claim 1, wherein at least a portion of the housing is transparent.

### Claim 33 (depends on 1)

The arrangement of claim 1, wherein the at least one seal is further configured to facilitate the creation of vacuum pressure at one of the plurality of the sampling and analysis sites.

### Claim 34 (depends on 33)

The arrangement of claim 33, wherein the at least one seal is configured to maintain vacuum pressure after passage of a triggering mechanism therethrough.

### Claim 35 (depends on 1)

The arrangement of claim 1 further comprising a barcode or a chip contained on or within the housing, wherein the barcode or chip comprises readable information.

### Claim 36 (depends on 35)

The arrangement of claim 35, where in the readable information comprises at least one of: calibration information, algorithm information, software code, and accuracy verification information.