Fully integrated wearable or handheld monitor

• US 20070179404A1
• Filed: 09/29/2006
• Published: 08/02/2007
• Est. Priority Date: 09/30/2005
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Rosedale Medical Inc. (Intuity Medical, Inc.)
• Inventors: Escutia, Raul, Litherland, Craig, Emery, Jeffrey, Pfeiffer, James, Pamichev, Christo
• Granted Patent: US 8,382,681 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2560/0462 Apparatus with built-in sensors
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150076 by heating
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/150954 : Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/150969 : Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 : Microneedles or microblades
• CPC Class Codes: A61B 5/151 : Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/15113 : Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15121 : comprising piezos
• CPC Class Codes: A61B 5/15123 : comprising magnets or solenoids
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/15148 : Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
• CPC Class Codes: A61B 5/15151 : Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 : Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/155 : Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/681 : Wristwatch-type devices
• CPC Class Codes: A61B 5/6824 : Arm or wrist
• CPC Class Codes: A61B 5/6828 : Leg
• CPC Class Codes: G01N 1/14 : Suction devices, e.g. pumps; Ejector devices
• CPC Class Codes: 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
• CPC Class Codes: G01N 21/77 : by observing the effect on a chemical indicator
• CPC Class Codes: G01N 27/416 : Systems G01N27/27 takes precedence

Abstract

An arrangement comprises a housing containing one or more components configured for at least one of body fluid sampling and analysis. The arrangement includes a housing containing one or more components configured for at least one of body fluid sampling and analysis, and a body attachment element. The housing and the body attachment element are connected by a quick-release mechanism configured to facilitate removal of the housing from the body attachment element.

Claims

1. An integrated body fluid sampling and analysis device, the device comprising:

a housing, the housing containing a plurality of body fluid sampling and analysis sites, each of the sites comprising a skin-penetration member;

a body attachment element; and

a quick release mechanism connecting the housing and the body attachment element.

2. The arrangement of claim 1, wherein the body attachment element comprises a band configured to be secured to the wrist of a wearer.

3. The arrangement of claim 1, further comprising a disposable portion and a reusable portion.

4. The arrangement of claim 1, wherein each of the sampling and analysis sites further comprises an actuator configured to drive the skin-penetration member into the skin of a user.

5. The arrangement of claim 4, wherein the actuator is configured to accelerate the skin-penetration member along a curved or rotational path.

6. The arrangement of claim 5, wherein the actuator comprises a torsional spring.

7. The arrangement of claim 4, wherein each of the sampling and analysis sites further comprise a trigger configured to release the actuator.

8. The arrangement of claim 1, wherein the skin-penetration member comprises a hollow needle.

9. The arrangement of claim 1, wherein the analyte quantification member comprises an assay pad, the assay pad comprising a chemical reagent for producing a detectable signal upon reaction with a target analyte.

10. The arrangement of claim 9, wherein the signal is optically detectable, and the arrangement further comprises a detector configured to detect the signal.

11. The arrangement of claim 1, wherein the analysis sites are arranged about a circle in a circumferential manner.

12. The arrangement of claim 11, wherein the analysis sites are oriented in the radial direction.

13. The arrangement of claim 1, wherein the sampling and analysis sites are oriented in a linear manner.

14. The arrangement of claim 4, wherein the actuator comprises a coil spring, the arrangement further comprising a relatively rotatable camming or ramping surface configured to interact with the coil spring such that energy stored therein is released at a predetermined release point.

15. The arrangement of claim 4, wherein the actuator comprises a cantilevered spring arm, the arrangement further comprising a release member and a rotatable surface formed with a break therein, the arrangement configured such that as the release member comes into registry with the break, the energy stored in the spring arm is released.

16. The arrangement of claim 1, wherein the skin-piercing member is attached to a first mounting arm, the arrangement further comprising at least one second mounting arm located above the first mounting arm, and a weight attached to the end of the second mounting arm, whereby the weight can be driven into the skin-piercing member attached to the first mounting arm.

17. The arrangement of claim 4, wherein the actuator comprises a cantilever beam and a rotatable cam comprising a ramp surface comprising a break therein and configured to interact with the cantilever beam to release energy stored therein upon coming into registry with the break.

18. The arrangement of claim 1, wherein the skin-penetration member comprises a bevel turned 90°

away from the surface of the skin of a user.

19. The arrangement of claim 1, wherein the skin-penetration member comprises a bevel facing toward the surface of the skin of a user.

20. The arrangement of claim 1, wherein the skin penetration member comprising a bevel facing away from the surface of the skin of a user.

21. The arrangement of claim 1, wherein the housing further comprises a display and one or more buttons.

22. The arrangement of claim 1, wherein the housing further comprises a footprint, the footprint comprising one or more openings in registry with one or more sampling and analysis sites.

23. The arrangement of claim 1, wherein the quick-release mechanism comprises a generally C-shaped portion, and a generally cylindrically-shaped portion received within the generally C-shaped portion with a snap-fit type connection.

24. The arrangement of claim 1, wherein the quick-release mechanism comprises a generally hollow portion disposed on the body attachment element received within a complementary generally hollow portion disposed on the housing, and a clip inserted into the generally hollow portion disposed on the housing, the clip comprising a locking feature disposed at an end of the clip.

25. The arrangement of claim 24, wherein the locking feature comprises a collapsible detent.

26. The arrangement of claim 1, wherein the quick-release mechanism comprises a generally hollow portion disposed on the body attachment element received within a complimentary generally hollow portion disposed on the housing, the generally hollow portion disposed on the body attachment element comprising a threaded end and a pin received therein, the pin comprises a threaded end mating with the threaded end of the end of the hollow portion.

27. The arrangement of claim 1, wherein the quick-release mechanism comprises a pocket formed in the body attachment element receiving the housing therein in a releasable manner in the form of one or more of:

a friction fit, snaps, detents or releasable fasteners.

28. The arrangement of claim 1, further comprising a case configured to receive the housing therein.

29. The arrangement of claim 28, wherein the case comprises a display.

30. The arrangement of claim 22, further comprising a moveable shield configured to close off the one or more openings.

31. The arrangement of claim 3, wherein the disposable portion comprises a disposable cartridge.

32. An arrangement comprising:

a housing containing one or more components configured for at least one of body fluid sampling or analysis; and

a body attachment element;

wherein the housing and the body attachment element are connected by a quick-release mechanism configured to facilitate removal of the housing from the body attachment element.

33. A method of performing at least one of body fluid sampling or analysis, the method comprising:

providing a housing with one or more components configured for at least one of body fluid sampling or analysis, the components comprising at least one skin-piercing member;

providing a body attachment element;

connecting the housing to the body attachment element in a releasable manner;

removing the housing from the body attachment element;

applying the housing to a surface of the skin; and

piercing the skin with the at least one skin-penetration members.

34. The method of claim 33, wherein the step of applying the housing to the surface of the skin comprises applying the housing to a tip region of a finger of the user.