Body fluid sampling device—sampling site interface

• US 9,833,183 B2
• Filed: 06/01/2009
• Issued: 12/05/2017
• Est. Priority Date: 05/30/2008
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Escutia, Ral, Litherland, Craig M., Emery, Jeffrey L., Jones, Jeffrey M., Tomasco, Michael F., Lipman, Kelley J.
• Primary Examiner(s): CERIONI, DANIEL LEE
• Application Number:
  US12/457,085
• Publication Number:
  US 20100010374A1
• Time in Patent Office: 3,109 Days
• Field of Search: 600583, 600573, 600578, 600584, 606181, 606183
• 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 5/150091 by electricity
• 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 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150832 by topography of the surface, e.g. Braille, embossed printing
• 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 5/150984 : Microneedles or microblades
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15109 : Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• 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 5/15151 : 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 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 5/422 : Desensitising skin

Abstract

An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes: a housing, the housing comprising a first opening; a skin interface member disposed in the first opening, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member and attached to the first opening; and at least one skin-penetration member configured and arranged to project within the second opening. Arrangements having alternatively constructed skin interface members are also described.

Claims

1. An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site, the arrangement comprising:

a housing, the housing comprising a plate member releasably mountable thereto, the plate member comprising a first opening;

a skin interface member disposed in the first opening and attached thereto, the skin interface member comprising an inner member having a second opening, and an outer member at least partially surrounding the inner member, the inner member having a first hardness and the outer member having a second hardness less than the first hardness, and wherein a perimeter portion of the outer member is affixed to the plate member and wherein the outer member is coplanar with the plate member and is configured to flex more than the inner member upon application of force to the skin interface member; and

at least one skin-penetration member configured and arranged to project within the second opening.

2. The arrangement of claim 1, wherein the housing is shaped and sized to be hand-held.

3. The arrangement of claim 1, wherein the skin interface member is removable from the first opening.

4. The arrangement of claim 1, wherein the second opening comprises an inner diameter of 3 mm-8 mm.

5. The arrangement of claim 4, wherein the inner diameter of the second opening is 6 mm.

6. The arrangement of claim 1, wherein the inner member and the outer member are integral.

7. The arrangement of claim 1, wherein the outer member is formed from elastomer, silicone rubber, soft plastic, or metal and the inner member is formed from metal, plastic or ceramic.

8. The arrangement of claim 1, wherein at least one of the housing, the inner member and the outer member is constructed so as to emit visible light thereby facilitating use in low-light conditions.

9. The arrangement of claim 1, wherein at least one of the housing, the inner member and the outer member is constructed so as to emit thermal energy.

10. The arrangement of claim 1, wherein the inner member comprises a textured surface for improving tactile feel of the user.

11. The arrangement of claim 1, wherein at least one of the inner member, the outer member, and the housing comprise one or more sensors capable of detecting when the skin interfacing member contacts the skin surface of the user at the sampling site.

12. The arrangement of claim 11, wherein the at least one sensor is capable of detecting the amount of force between the skin interfacing member and the skin surface.

13. The arrangement of claim 12, wherein the arrangement is constructed to provide audible and/or visual feedback to the user based on information derived from the sensor.

14. The arrangement of claim 12, wherein the arrangement is constructed to automatically initiate one or more functions or operations based on information derived from the sensor.

15. The arrangement of claim 14, wherein the arrangement is constructed to automatically initiate an automated sample collection sequence after at least one of a minimum degree of force is sensed between the skin and the skin interfacing member, or minimum duration of contact between the skin interface member and the skin is sensed.

16. The arrangement of claim 1, further comprising:

a cartridge disposed within the housing, wherein the at least one skin-penetration member is disposed within the cartridge.

17. The arrangement of claim 16, wherein the cartridge further comprises at least one analyte quantification member.

18. The arrangement of claim 17, wherein the analyte quantification member comprises an assay pad containing a chemical reagent.

19. The arrangement of claim 18, further comprising a plurality of skin-penetration members, a plurality of actuators, and a plurality of analyte quantification members, operatively arranged in the disposable cartridge such that multiple tests can be performed using the arrangement without replacing the cartridge.

20. The arrangement of claim 19, wherein the cartridge is moveable in order to present a new skin-penetration member, actuator and analyte quantification member for use after the performance of a preceding sampling event.

21. The arrangement of claim 1, wherein device is configured for fingertip sampling, alternate site sampling, or alternative fingertip/alternate site sampling at the election of the user.

22. The arrangement of claim 16, wherein the cartridge comprises an outer surface, and wherein the skin interface member is constructed and arranged to form a seal with the outer surface of the cartridge upon being pressed against the skin of the user.

23. The arrangement of claim 1, wherein the position of the skin interface member relative to the housing is adjustable.

24. The arrangement of claim 23, wherein the maximum depth that the skin penetrating member can penetrate the skin is controlled by the position of the skin interface member.

25. The arrangement of claim 23, wherein the skin interface member is attached to the housing by a threaded connection.

26. The arrangement of claim 1, wherein the outer member is provided with a configuration which provides an audible or tactile sensation to the user upon pressing the skin against the inner member of the skin interface member with a predetermined degree of force.

27. The arrangement of claim 1, wherein the skin interface member comprises a punching or cutting mechanism.

28. The arrangement of claim 27, wherein the punching or cutting mechanism comprises a downwardly projecting member having a portion shaped to reduce the force required to punch through a frangible material.

29. The arrangement of claim 27, wherein the punching or cutting mechanism comprises a downwardly projecting member having a sharpened portion formed on the inner member.

30. The arrangement of claim 27, further comprising a cartridge having at least one opening covered and sealed by a frangible material, and wherein the punching or cutting mechanism is configured to break through the frangible material in the vicinity of the at least one opening.

31. The arrangement of claim 30, wherein the frangible material comprises a foil.

32. The arrangement of claim 1, wherein the inner member is constructed so as to selectively change a diameter of the second opening.

33. The arrangement claim 32, wherein the inner member is constructed, at least in part, from a shape-memory material.

34. The arrangement of claim 33, wherein the inner member is constructed from a plurality of relatively movable and collapsible segments.

35. The arrangement of claim 34, wherein the inner member is provided with a keyhole-like configuration comprising a first portion having a first diameter opening, and a second portion comprising a relatively smaller second diameter opening.

36. The arrangement of claim 1, wherein the inner member is constructed so as to automatically change a diameter of the second opening.

37. The arrangement of claim 36, wherein the diameter of the second opening is automatically changed based on the result of previous sample collections.

38. The arrangement of claim 37, wherein at least one of the inner member, the outer member, and the housing comprise one or more sensors capable of detecting when the skin interfacing member contacts the skin surface of the user.

39. The arrangement of claim 38, wherein the diameter of the second opening is automatically reduced when the sensors do not detect contact with skin surface.

40. The arrangement of claim 1, wherein at least one of the inner member, outer member or housing has hydrophilic surface properties.

41. The arrangement of claim 1, wherein at least one of the inner member, outer member or housing has hydrophobic surface properties.