Health Monitoring Device, Device Modules and Method

• US 20080200782A1
• Filed: 07/19/2006
• Published: 08/21/2008
• Est. Priority Date: 07/19/2005
• Status: Active Grant

• Current Assignee: i-SENS, Inc.
• Original Assignee: IHQ Innovation Headquarters Oy
• Inventors: Planman, Jukka, Planman, Tuomas
• Granted Patent: US 8,062,235 B2
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150725 removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
• 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 5/15186 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 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

The present invention relates to a health monitoring device for measuring blood or tissue indicators and a strip cassette suitable for use in connection with the device. The device comprises a body (6) having a first opening (5) and a second opening (4), a piercing means (7) having a piercing head and connected to the body, the piercing means being arranged to extend from the first opening of the body and being cockable and further releasable for piercing the skin with the piercing head, and a space (17) arranged in connection with the body, into which space a number of sensor strips (12) can be arranged so that the strips can be brought out from the body one at a time. According to the invention the device comprises a shutter (1) functionally connected to the body, the shutter being arranged to tightly close the first and second openings of the body in its first position and which can be moved to the second position for allowing one sensor strip to be pushed from the first opening of the body into sampling position and for exposing the first and second openings of the body. With the invention an easy to use, easily portable and small device for repeated measurement of blood indicators can be produced.

Claims

1. A health monitoring device for measuring blood or tissue fluid indicators, the device comprising

a body having a first opening and a second opening,

a piercing means attached to the body and having a piercing head arranged to extend out from the first opening of the body, the piercing means being cockable and further releasable for piercing the skin with its piercing head, and

a space arranged in connection with the body, into which space a number of sensor strips can be arranged so that they can be brought out from the device one by one through the second opening of the body into sampling position, wherein

a shutter being arranged to tightly cover in its first position the first and the second opening of the body, the shutter being movable to a second position for exposing the first and the second opening of the body, whereby a sensor strip can be pushed from the second opening of the body, the sensor strip thus being capable of being brought into sampling position when the shutter is in its second position.

2. The health monitoring device according to claim 1, wherein the shutter is functionally connected to the piercing means, whereby the piercing means is arranged to be cocked when the shutter is moved from the first position into the second position.

3. The health monitoring device according to claim 1, wherein the sensor strips can be brought into the device in a strip cassette.

4. The health monitoring device according to claim 1, wherein the shutter is functionally connected to the sensor strip feed device as well for connecting the feed to the movement of the shutter.

5. The health monitoring device according to claim 1, wherein the sensor strips can be arranged into the device as a spiral-like belt.

6. The health monitoring device according to claim 5, wherein the shutter is rotatable in relation to the body between the first and second positions in a plane defined by the spiral belt.

7. The health monitoring device according to claim 1, wherein the shutter is slidable essentially along the surface of the body.

8. The health monitoring device according to claim 1, wherein it additionally comprises a release installed in the body for releasing the piercing means.

9. The health monitoring device according to claim 1, wherein the sensor strips comprise a sampling area and electronic or optical contacts connected to the sampling area for analysing the sample brought to the sampling area and the device comprises contact surfaces arranged to connect with the electronic or optical contacts of the sensor strip being brought to sampling position.

10. The health monitoring device according to claim 9, wherein the said connecting is arranged to happen when the shutter is brought from the first position to the second position.

11. The health monitoring device according to claim 1, wherein in the space into which a number of sensor strips can be arranged, are means for transmitting the force pushing the sensor strip from the shutter to the strip being pushed out.

12. The health monitoring device according to claim 1, wherein there is a seal arranged between the body and the shutter or between two shutter parts.

13. The health monitoring device according to claim 1, wherein the shutter is adapted to be locked in the second position.

14. The health monitoring device according to claim 1, wherein it comprises a source of light arranged in the vicinity of the first and second openings, the source of light being functionally connected to the shutter so that it is off when the shutter is in its first position and on when the shutter is in its second position.

15. The health monitoring device according to claim 1, wherein it comprises means for mechanically connecting the device to a host device, such as a mobile phone or a wrist computer.

16. The health monitoring device according to claim 1, wherein it comprises means for electrically or optically connecting the device to a host device, such as a mobile phone, computer or a wrist computer for transferring the measurement data into a host device.

17. The health monitoring device according to claim 1, wherein it comprises electronic means that can be connected to the contacts of the sensor strip pushed partially out from the second opening of the body for analysing the blood brought to the sampling area.

18. The health monitoring device according to claim 17, wherein it comprises a display for displaying the result of the analysis.

19. The health monitoring device according to claim 17, wherein it comprises a memory for storing the results of the analysis.

20. The health monitoring device according to claim 1, wherein the space into which a number of sensor strips can be arranged, can be sealedly closed when the strip to be exposed is brought away from the space.

21. The health monitoring device according to claim 20, wherein the sensor strips can be arranged into the device as a spiral-like belt and the device comprises means for cutting the belt and for sealedly closing the space into which a number of sensor strips can be arranged when the strip to be exposed is brought away from the space.

22. The health monitoring device according to claim 1, wherein the shutter comprises two-parts, whereby the first and second shutter part are arranged to be separately movable in one direction in relation to the body part, whereby the bringing of the sensor strip into sampling position and/or the cocking of the piercing means is functionally connected to the movement of the first and/or second shutter part.

23. The health monitoring device according to claim 22, wherein the first and second shutter parts are arranged to be positioned against each other along, for example, a dividing seam arranged diagonally against the direction of their movement and thus to sealedly enclose the body within.

24. The health monitoring device according to claim 1, wherein the piercing means is arranged to move into a better position, such as to extend partly out from the device, when the shutter is moved from the first position to the second position or in connection with another function.

25. The health monitoring device according to claim 1, wherein the device comprises a housing part arranged partly over the body, whereby the shutter is functionally connected to the body and the said housing part so that in the first position of the shutter the body and housing part are locked against each other in a sealed way.

26. The health monitoring device according to claim 25, wherein a seal is arranged between the body and the housing part so that the inner part of the body is airtightly closed at the area of the seam between the body and the housing part.

38. The method according to claim 35, wherein the device according to any of claims 1-26 is used.

27. A cassette for storing and using strip-like sensor elements used for taking and analysing a blood sample, the cassette comprising

covers,

a hub rotatably connected to the covers,

a number of sensor elements arranged inside the covers, wherein

the sensor elements are arranged one after the other as a spiral-like band, and

the spiral is mechanically connected to the hub for transmitting force to the outermost sensor element of the spiral for pushing it out of the cassette when the hub is rotated.

28. The cassette according to claim 27, wherein the sensor elements are fastened to each other so that a cutting zone remains between the elements.

29. The cassette according to claim 27, wherein the sensor elements are fastened to a narrow substrate strip separately from each other.

30. The cassette according to claim 27, wherein each sensor element comprises a measurement area comprising a capillary cavity extending in the plane of the sensor element.

31. The cassette according to claim 27, wherein each sensor element comprises a measurement area covered by a protective sticker, foil or piece of plastic.

32. A sensor element arrangement comprising a number of disposable sensor strips, each of which comprises at least one measurement area and electronic or optical contacts for analysing the sample arranged on the measurement area, wherein the sensor strips are arranged one after another in their longitudinal direction as a flexible band, from which the strips can be cut off one at a time.

33. The sensor element arrangement according to claim 32, wherein the measurement areas of the sensor strips are covered by removable protective stickers.

34. The sensor element arrangement according to claim 32, wherein the sensor elements are connected to each other so that a cutting zone remains between them.

35. A method for carrying out an at least two-step health monitoring measurement, in which a portable health monitoring device is used, the device comprising a first means for carrying out the first step of the method and a second means for carrying out the second step of the method, wherein the health monitoring device comprises a shutter which in its first position covers the first and second means and

the shutter is brought into the second position for exposing the first and second means and for bringing the first, second or both means into operation position,

the first and second means are operated when the shutter is in its second position,

the shutter is returned to the first position.

36. The method according to claim 35, wherein blood or tissue fluid indicators are measured in it, whereby

the first means comprise a piercing means for bringing out blood or tissue fluid,

the second means comprise sensor strips which can be brought out of the health monitoring device one at time and removable from the device after the measurement.

37. The method according to claim 35, wherein the device is held and used with only one hand during the measurement.