Lancet-integrated sensor, measurer for lancet-integrated sensor, and catridge

• US 20030144608A1
• Filed: 11/26/2002
• Published: 07/31/2003
• Est. Priority Date: 01/19/2001
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: Kojima, Shinichi, Tokuno, Yoshinobu
• Granted Patent: US 7,691,071 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/0006 ECG or EEG signals
• 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 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150717 manually removed
• 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 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• 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

A sensor and a lancet are integrated with each other to facilitate replacement and management thereof, and further, portability thereof is improved.

That is, a thin strip-shaped sensor (1) and a lancet (2) are integrated so that the lancet (2) moves in parallel, along the longitudinal direction of the sensor (1).

On the other hand, a measuring device to which an integrated lancet and sensor 10 is attached is provided with a function of driving the attached lancet.

Claims

1. A lancet-integrated sensor which is constituted by integrating a lancet for lancing the skin of a subject to extract its bodily fluid, and a sensor body for analyzing the extracted bodily fluid, wherein

the sensor body has a shape of a long and narrow strip, and the lancet is driven along the longitudinal direction of the sensor body by an external driving means, thereby lancing the skin.

2. A lancet-integrated sensor as defined in claim 1, wherein

the sensor body has an internal space through which the lancet can pass, and holds the lancet in the space.

3. A lancet-integrated sensor as defined in claim 2, wherein

a long and narrow space for housing the lancet is formed in the sensor body.

4. A lancet-integrated sensor as defined in any of claims 1 to 3, wherein

the sensor body is obtained by bonding two thin plates together, and at least one of the two plates has a concave portion;

and

the lancet is stored in a space which is formed by the concave portion of the two plates bonded together.

5. A lancet-integrated sensor as defined in any of claims 1 to 4, wherein

when the lancet lances the skin to extract the bodily fluid, the lancet projects its needle tip from the inside of the sensor body in which the lancet is stored.

6. A lancet-integrated sensor as defined in any of claims 1 to 5, wherein

a cavity for collecting the bodily fluid is provided separately from the space in the sensor body where the lancet is housed.

7. A lancet-integrated sensor as defined in any of claims 1 to 6, wherein

the space in the sensor body for housing the lancet also serves as a cavity for collecting the bodily fluid;

and

the bodily fluid is collected into the space for housing the lancet.

8. A lancet-integrated sensor as defined in any of claims 1 to 6, wherein

an inlet of a cavity for collecting the bodily fluid is provided at an end of the sensor from which the needle tip of the lancet is projected.

9. A lancet-integrated sensor as defined in any of claims 1 to 8, wherein

the sensor body has, in-a cavity, an electrode for outputting the analysis result of the characteristics of the bodily fluid.

10. A lancet-integrated sensor as defined in claim 9, wherein

a connection terminal to be connected with an external measuring device to electrically measure the characteristics of the bodily fluid is provided at an end of the sensor body having the cavity.

11. A lancet-integrated sensor as defined in any of claims 1 to 10, wherein

a reagent that reacts with the collected bodily fluid is provided in the cavity.

12. A lancet-integrated sensor as defined in any of claims 1 to 10, wherein

an end of the lancet on the side opposite to the needle tip projects from the sensor body;

and

the projecting end is engaged with a driving means of the external measuring device, whereby the lancet is driven to perform the skin lancing operation.

13. A lancet-integrated sensor as defined in claim 12, wherein

a connector to be engaged with the driving means of the external measuring device is provided at the end of the lancet on the opposite side to the needle tip;

and

the connector is engaged with the driving means, whereby the lancet performs the skin lancing operation.

14. A lancet-integrated sensor as defined in claim 13, wherein

the connector is made of a resin, and has a diameter larger than that of the lancet.

15. A lancet-integrated sensor as defined in any of claims 1 to 14, wherein

a detachable protection cover is-fitted to the needle tip of the lancet;

and

the protection cover is removed during the skin lancing operation of the lancet.

16. A lancet-integrated sensor as defined in claim 15, wherein

the protection cover has a tube part for housing the needle tip in it, and a wide grip part for facilitating removal of the protection cover from the lancet, which grip part is provided on the needle tip side of the tube part.

17. A lancet-integrated sensor as defined in claim 15, wherein

engagement of the lancet and the driving means, and attachment of the sensor body integrated with the lancet to the measuring device are performed with holding the grip part of the protection cover.

18. A lancet-integrated sensor as defined in claim 16, wherein

a space in which the front end of the sensor body can be housed is formed in the tube part.

19. A lancet-integrated sensor as defined in any of claims 1 to 18 being provided with a holder which covers the periphery of the integrated sensor body and lancet to hold them.

20. A lancet-integrated sensor as defined in claim 19, wherein

the holder is made of a transparent material.

21. A lancet-integrated sensor as defined in any of claims 1 to 20 being of a disposal type, which will be discarded after performing collection and analysis of the bodily blood one time.

28. A measuring device as defined in any of claims 21 to 27, wherein

a lancet-integrated sensor as defined in any of claims 15 to 18 is detachably attached to the measuring device;

and

attachment of the lancet-integrated sensor to the measuring device is carried out with the tip of the lancet being covered with a protection cover, the sensor is held by the connector of the measuring device, and an end of the lancet on the opposite side to the needle tip is supported by the lancet driving means.

29. A measuring device as defined in any of claims 22 to 28, wherein

a lancet-integrated sensor as defined in any of claims 19 to 20 is detachably attached to the measuring device;

and

the sensor is held by the connector, and an end of the lancet on the opposite side to the needle tip or the grip part of the protection cover is held by the driving means, in accordance with the operation of engaging the holder with the measuring device, so that the sensor and the lancet are attached to the measuring device in the state where the sensor and the lancet are being held by the holder.

22. A measuring device to which a lancet-integrated sensor that is constituted by integrating a lancet for lancing the skin of a subject to extract its bodily fluid, and a sensor body for analyzing the extracted bodily fluid, is detachably attached, for measuring the characteristics of the bodily fluid collected by the lancet-integrated sensor, said measuring device including:

a lancet driving means for driving, after the lancet-integrated sensor is attached to the measuring device, the lancet so as to lance the skin.

23. A measuring device as defined in claim 22, wherein

at least one end of the lancet-integrated sensor is projected from the measuring device when attachment of the lancet-integrated sensor to the measuring device is completed.

24. A measuring device as defined in claim 22 or 23, wherein

the lancet driving means drives the lancet of the lancet-integrated sensor so that the needle tip of the lancet is projected from the sensor only when it lances the skin to collect the bodily fluid and, at all other times, the needle tip is housed in the sensor.

25. A measuring device as defined in claim 24 being provided with a connector for maintaining electrical connection with an electrode terminal that is placed at an end of the sensor body of the lancet-integrated sensor, to measure the characteristics of the collected bodily fluid by an internal electric circuit.

26. A measuring device as defined in any of claims 22 to 25, wherein

the lancet driving means drives the lancet when it is engaged with an end of the lancet on the opposite side to the needle tip, or when a grip part of a protection cover is griped.

27. A measuring device as defined in claim 26, wherein

the lancet driving means has a spring for applying a force to the lancet in the longitudinal direction of the sensor, and the force of the spring is released by a press button that is provided on the measuring device to project the lancet.

30. A measuring device as defined in any of claims 22 to 29, wherein

a lancet-integrated sensor which has been used is ejected from the measuring device body without being touched with hands, by operating an operation button that is provided on the measuring device body.

31. A measuring device as defined in any of claims 22 to 30, wherein

the amount of projection of the needle tip of the lancet from the front end of the sensor is displayed on a display means that is provided on the measuring device body.

32. A lancet-integrated sensor which is constituted by integrating a lancet having a needle for lancing skin to collect bodily fluid, and a sensor for analyzing the collected bodily fluid, wherein

a cavity for slidably housing a part of the lancet is formed in the sensor;

and

a force is applied to the lancet in a direction opposite to the direction along which the needle lances the skin, to house the needle in the sensor, whereby the lance and the sensor are locked with each other.

33. A lancet-integrated sensor as defined in claim 32, wherein

the lancet comprises an approximately-rectangle-shaped plate member;

the needle of the lancet is arranged in the vicinity of the center of one of the shorter sides of the plate member so that it projects along the longitudinal direction of the plate member;

the cavity is formed in a shape approximately identical to an outline shape that is obtained when the lancet is slid by a predetermined amount along the longitudinal direction thereof; and

openings for projecting the needle and the other side of the lancet to the outside of the sensor are formed at the front end and the rear end of the sensor, respectively.

34. A lancet-integrated sensor as defined in claim 32 or 33, wherein

either a convex portion for locking or a concave portion for locking is formed on the lancet, and either a concave portion for locking or a convex portion for locking which is engaged with the convex portion or the concave portion of the lancet is formed on the sensor;

and

the lancet and the sensor are locked with each other when the convex portion for locking and the concave portion for locking are engaged with each other.

35. A lancet-integrated sensor as defined in claim 34, wherein

the lancet has two plate-shaped projections which project from the two longer sides of the lancet in the width direction;

the projections have the concave portions for locking on their upper surfaces;

a cavity for slidably housing the lancet, which is formed in the sensor, has two depressions for housing the two projections of the lancet, which depressions project in the width direction of the cavity; and

the depressions have the concave portions for locking at their ceilings.

36. A measuring device for performing measurement using a lancet-integrated sensor as defined in claim 33, comprising:

a guide member for guiding the lancet-integrated sensor that is inserted from an opening provided on a side surface of the measuring device, thereby restricting the direction along which the lancet-integrated sensor travels in the measuring device;

a lancet pressing member which is pushed by a spring member in the measuring device in a direction opposite to the direction along which the lancet-integrated sensor is inserted, and is engaged with the other shorter side of the lancet that is guided toward the inside of the measuring device by the guide member, thereby pressing the lancet toward the opening;

a locking member for fixing the lancet pressing member at a predetermined position in the measuring device when the lancet-integrated sensor is inserted deeper into the measuring device;

an unlocking member for releasing fixation of the lancet pressing member by the locking member, with manual operation; and

an ejection member for applying a force to the sensor of the lancet-integrated sensor to push the sensor toward the opening side, with manual operation, which ejection member is provided between the lancet pressing member-and the guide member.

37. A measuring device for a lancet-integrated sensor as defined in claim 36, wherein

the ejection member slides an operation lever that is exposed at the main surface of the measuring device, toward the opening side, whereby a pressing member that is united with the operation lever presses the vicinity of both sides of an end of the lancet-integrated sensor, which end is opposite to the side where the lancet lances the skin, thereby ejecting the lancet-integrated sensor.

38. A measuring device for performing measurement using a lancet-integrated sensor which is constituted by integrating a lancet for lancing skin to collect bodily fluid, and a sensor for analyzing the collected bodily fluid, wherein

the measuring device for the lancet-integrated sensor has an opening on a side surface;

the measuring device has a cavity in which the lancet-integrated sensor can be housed, which cavity is formed corresponding to the opening;

a holder attachment part is formed on the side of the measuring device having the opening, which holder attachment part detachably attaches a holder body in which the lancet-integrated sensor can path through, to the measuring device; and

the holder body guides the lancet-integrated sensor-when the lancet-integrated sensor is housed in the cavity and, after it is housed in the cavity, the holder body holds a portion of the lancet-integrated sensor in the vicinity of the end where the lancet lances the skin.

39. A measuring device for a lancet-integrated sensor as defined in claim 38, wherein

engagement portions of the holder and the holder attachment part have asymmetrical shapes in the vertical direction or in the horizontal direction;

and

attachment of the holder to the holder attachment part is possible only when the vertical direction of the holder with respective to the holder attachment part is a predetermined direction.

40. A measuring device for a lancet-integrated sensor as defined in claim 38, wherein

the opening of the holder attachment part into which the holder body is inserted has a shape of an approximately rectangle that is side-to-side long, with portions corresponding to the corners of the rectangle being rounded, and the opening has smaller openings overhanging in the width direction in the vicinities of the centers of two sides in the longitudinal direction.

41. A measuring device for a lancet-integrated-sensor as defined in claim 40, wherein

the holder body has hinge-shaped stoppers;

inner sides of the hinge-shaped stoppers are fixed to the holder body; and

outer sides of the hinge-shaped stoppers are engaged with the engagement portions of the holder attachment part.

42. A measuring device for a lancet-integrated sensor as defined in claim 40, wherein

the holder body has a peripheral edge part that extends along the surface of the opening, at the periphery of the opening excluding the smaller openings, on the side where the holder body is attached to the measuring device;

the hinge-shaped stoppers are provided in portions of the peripheral edge part corresponding to the smaller openings; and

the hinge-shaped stoppers are obtained by extending band-shaped elastic members in the direction along which the lancet-integrated sensor is impacted into the holder body, and bending the elastic members outward at 180°

.

43. A measuring device for a lancet-integrated sensor as defined in claim 42, wherein

each of the hinge-shaped stoppers has a clip member at the front end of the band-shaped elastic member, which clip member is thicker than the elastic member, and performs positioning when the holder body is latched in the opening.

44. A biosensor cartridge for housing plural biosensors, each having a reagent layer for detecting a specific component in bodily fluid of a subject, and an electrode for taking out an electric signal indicating that the reagent layer detects the specific component, wherein

a cartridge body has, at an end of its upper surface, a hinge for rotatably fixing a lid that covers the cartridge;

the cartridge body has plural slits for perpendicularly supporting the respective biosensors; and

the plural slits are formed in parallel with each other, from the upper surface toward the lower surface of the cartridge body, at regular intervals which allow an insertion slot of a measuring device for performing measurement using a target biosensor to be inserted without touching biosensors adjacent to the target biosensor.

45. A biosensor cartridge as defined in claim 44, wherein

the cartridge body to which the lid is attached is a rectangular parallelepiped in shape.

46. A biosensor cartridge as defined in claim 45, wherein

the lid is a hollow rectangular parallelepiped in shape, and has an opening at a portion opposed to the upper surface of the cartridge body.

47. A biosensor cartridge as defined in claim 44, wherein

the bottom of each slit has a shape that conforms to the shape of the front end of the biosensor.

48. A biosensor cartridge as defined in claim 47, wherein

the front end of the biosensor is semi-circular in shape.

49. A biosensor cartridge as defined in claim 44, wherein

the hinge is constituted by

a pair of bearings each having a side-to-side long bearing hole that projects outward along the longitudinal direction of the cartridge body from an end of the upper surface of the cartridge body, and

a pair of axial projections which are provided at an end of the lid, and serve as fulcra when being smooth-movably engaged with the bearings to rotate the lid;

a peripheral edge part is formed at the periphery of the upper surface of the cartridge body, which part extends in a direction perpendicular to the side walls of the cartridge body,

and has plural notches;

reverse-L-shaped projections are formed on the same plane as the side walls of the lid, in positions corresponding to-the notches of the peripheral edge part, at the periphery of the opening of the lid; and

a sealing member having elasticity is formed on the upper surface of the peripheral edge part.

50. A biosensor cartridge for housing plural lancet-integrated biosensors, each being constituted by integrating a biosensor having a reagent layer for detecting a specific component in bodily fluid of a subject, and an electrode for taking out an electric signal indicating that the reagent layer detects the specific component, with a lancet for collecting the bodily fluid of the subject, wherein

the cartridge body has, at an end of its upper surface, a hinge for rotatably fixing a lid that covers the cartridge body;

the cartridge body has plural grooves for perpendicularly supporting the lancet-integrated biosensors; and

the plural grooves are formed in parallel with each other, from the upper surface toward the lower surface of the cartridge body, at regular intervals which allow an insertion slot of a measuring device for performing measurement using a target biosensor to be inserted without touching biosensors adjacent to the target biosensor.

51. A biosensor cartridge as defined in claim 50, wherein

the lancet-integrated biosensor includes

an approximately-square-shaped and narrow protector for protecting the lancet that projects from the lancet-integrated biosensor in its unused state,

a sensor body in which the lancet is smooth-movably housed, the sensor body being approximately rectangle in shape, has a front end being semi-circular in shape, and is a little wider than the protector, and

a connector which is provided on the lancet, protrudes backward from the sensor body, and has a width approximately equal to the width of the sensor body;

wherein each of the plural grooves comprises

a narrow first groove which is provided at the lowest surface side of the cartridge body, and conforms to the shape of the protector,

a second groove which is wider than the first groove, is provided above the first groove, and conforms to the shape of a portion of the sensor body, and

a third groove which is wider than the second groove, is provided above the second groove, and conforms to the shape of the insertion slot part of the measuring device into which the sensor body is inserted.

52. A biosensor cartridge as defined in claim 51, wherein

the insertion slot stores the sensor body into a cavity which penetrates a pillar-shaped projection that projects from a side surface of the measuring device;

and

the connector is stored in the cavity that extends into the measuring device.

53. A measuring device for performing measurement using a lancet-integrated sensor that is attached thereto, said lancet-integrated sensor being constituted by integrating a lancet for lancing skin to collect bodily fluid, and a sensor for analyzing the extracted bodily fluid, said measuring device including:

a drive means for driving the lancet in a direction in which the lancet lances the skin, along the longitudinal direction of the sensor, from the standby position of the lancet;

wherein, after the drive means has driven the lancet in the direction in which the lancet lances the skin, the drive means can drive the lancet back to the standby position while maintaining the state where the lancet-integrated sensor is attached to the measuring device.

54. A measuring device for a lancet-integrated sensor as defined in claim 53, wherein

the drive means has a shaft to which a connector receiver is fixed at an end on the side where the lancet lances the skin, which connector receiver receives an end of the lancet on the side opposite to the side where the lancet lances the skin;

a pull stick for driving the lancet back in a direction opposite to the direction in which the lancet lances the skin is disposed on an end of the shaft on the side opposite to the side where the lancet lances the skin; and

the connector receiver is provided with a claw portion which is unlocked by pressing an operation button to start the operation of the drive means, and stops the motion of the connector receiver against a force applied by a spring that is provided on the shaft to move the connector receiver in the direction in which the lancet lances the skin.

55. A measuring device for a lancet-integrated sensor as defined in claim 54, wherein

the measuring device has, in its internal cavity, a support member for slidably supporting the shaft in the vicinity of its center;

and

the spring is a coil spring which is placed between the support member of the shaft and the connector receiver.

56. A measuring device for a lancet-integrated sensor as defined in claim 54, wherein

the pull stick has an opening which is formed at an end of the side where the lancet lances the skin;

an end of the shaft on the side opposite to the side where the lancet lances the skin is slidably housed in the pull stick through the opening; and

the end of the shaft on the side opposite to the side where the lancet lances the skin has a slip-out prevention member for preventing the end of the shaft to slipping out of the pull stick toward the side where the lancet lances the skin.

57. A measuring device for a lancet-integrated sensor as defined in claim 54, wherein

the driving means is provided with a lancet projection amount adjuster for adjusting the amount of projection of the needle of the lancet that lances the skin, which driving means is placed between the measuring device and the pull stick.

58. A measuring device for a lancet-integrated sensor as defined in claim 57, wherein

the pull stick is approximately cylindrical in shape, and an end of the pull stick on the side opposite to the side where the lancet lances the skin has a handle part having a portion of a diameter larger than the diameter of the cylindrical part;

the lancet projection amount adjuster is approximately cylindrical in shape, and an end of the adjuster on the side opposite to the side where the lancet lances the skin has an opening having a diameter equal to the diameter of the cylindrical part of the pull stick; and

the cylindrical part is slidably housed through the opening, and the cylindrical part is screwed into a screw hole that is formed on a side surface of the measuring device on the side opposite to the side where the lancet lances the skin, toward the inside of the measuring device, whereby the cylindrical part rotates in the screw direction or in the opposite direction to adjust the amount of projection of the lancet.