BLOOD GLUCOSE MANAGEMENT

• US 20140323915A1
• Filed: 07/19/2013
• Published: 10/30/2014
• Est. Priority Date: 04/29/2013
• Status: Active Grant

• Current Assignee: POPS! Diabetes Care Inc.
• Original Assignee: Birch Narrows Development Llc
• Inventors: Christensen, Curtis, Davis, Daniel, Davis, Erik
• Granted Patent: US 9,237,866 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150358 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150633 Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
• 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 5/150862 intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150893 by indicating if used, tampered with, unsterile or defective
• 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 5/15101 Details
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15142 : Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15144 : comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/15151 : Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15163 : Characterized by propelling the piercing element in an axial direction relative to the disc
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/7405 : using sound
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7445 : Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/7455 : characterised by tactile indication, e.g. vibration or electrical stimulation

Abstract

This disclosure provides equipment and processes for blood glucose management. Embodiments may comprise a lancet device that includes a base that supports a lancet and a cover. The cover can move controllably from an un-depressed position to a depressed position when a predetermined force is applied. The cover can provide access to the lancet in the depressed position. In another aspect, a biological test kit may include a reusable module and a disposable module. The disposable module may include one or more lancet devices such as that described above to collect a biological sample, one or more strip stations supporting biological strips and a disposable module connector. The reusable module may support measuring equipment to measure a property of the biological sample and a reusable module connector that engages removably with the disposable module connector.

Claims

1. A lancet device comprising:

(a) a base that includes a support surface;

(b) a lancet supported by the base and extending away from the support surface at an angle of approximately 90°

;

(c) a cover that includes (i) a peripheral edge along which the cover is connected to the base, (ii) a cover region configured to cover the lancet when the cover is in an un-depressed position, the cover region having a cover region geometry, (iii) a lancet aperture through which the lancet is configured to protrude when the cover is in a depressed position, and (iv) a peripheral hinge near the peripheral edge, the peripheral hinge having a peripheral hinge geometry that differs from the cover region geometry to facilitate controlled movement of the cover from the un-depressed position to the depressed position upon application of a predetermined depression force.

2. The lancet device of claim 1, wherein the cover is configured to provide an auditory and/or tactile response as the cover moves from the un-depressed position to the depressed position upon application of the predetermined depression force.

3. The lancet device of claim 1, wherein the cover is configured to provide a force response to facilitate movement of the cover from the depressed position back to the un-depressed position upon removal of the predetermined depression force.

4. The lancet device of claim 1, wherein

the cover further includes (v) a spike extending toward the base, and

the lancet device further comprises (d) a cavity on the base under the cover, the cavity being configured to release pressurized gas upon being pierced by the spike as the cover moves from the un-depressed position to the depressed position, thereby urging the cover toward the un-depressed position.

5. The lancet device of claim 1, wherein the cover further includes (v) a release aperture to release trapped air that impedes controlled movement of the cover.

6. The lancet device of claim 1, wherein the base includes a visual indicator that shows if the cover has been moved from the un-depressed position to the depressed position.

7. The lancet device of claim 1, further comprising:

(d) a cap positionable from (i) a capped position in which the cap is in close proximity to the base, covering the cover and preventing access to the lancet to (ii) an uncapped position in which the cap facilitates access to the lancet.

8. The lancet device of claim 7, wherein the cap is configured to act as a sterile barrier when in the capped position to isolate the lancet from contaminants.

9. The lancet device of claim 7, wherein the cap is hingedly coupled to the base.

10. The lancet device of claim 1, further comprising:

(d) a stop on the base under the cover, the stop being configured to dictate a distance by which the lancet is configured to protrude through the lancet aperture when the cover is in the depressed position.

11. The lancet device of claim 1, wherein the cover region geometry comprises a cover region wall thickness, and the peripheral hinge geometry comprises a peripheral hinge wall thickness that is less than half of the cover region wall thickness.

12. The lancet device of claim 1, wherein the predetermined depression force is between approximately 700 grams and approximately 2000 grams.

13. A biological test kit comprising:

(a) a reusable module comprising (i) a reusable module housing, (ii) measuring equipment supported by the reusable module housing and configured to measure a property of a biological sample, and (iii) a reusable module connector supported by the reusable module housing;

(b) a disposable module comprising (i) a disposable module housing, (ii) a first lancet station supported by and stationary relative to the disposable module housing, the first lancet station being configured to facilitate generation of a first biological sample, (iii) a first strip station supported by the disposable module housing and including a first biological strip configured to receive the first biological sample and to provide the first biological sample to the measuring equipment for measurement of the property, and (iv) a disposable module connector supported by the disposable module housing and being modularly connectible to the reusable module connector.

14. The biological test kit of claim 13, wherein the disposable module housing comprises (A) a first sub-module housing that supports the first lancet station and includes a first sub-module connector and (B) a second sub-module housing that supports the first strip station and includes a second sub-module connector that is modularly connectible to the first sub-module connector.

15. The biological test kit of claim 13, wherein the disposable module further comprises (v) a second lancet station supported by and stationary relative to the disposable module housing, the second lancet station being configured to facilitate generation of a second biological sample and (vi) a second strip station supported by the disposable module housing and including a second biological strip configured to receive the second biological sample and to provide the second biological sample to the measuring equipment for measurement of the property.

16. The biological test kit of claim 13, wherein the disposable module connector and the reusable module connector together comprise an interlocking fastener.

17. The biological test kit of claim 13, wherein the first strip station includes a slot in the disposable module housing and a strip container positioned in the slot, the strip container being configured to slide into and out of the slot between a closed position and an open position and being adapted to provide access to the first biological strip when in the open position.

18. The biological test kit of claim 13, wherein the first strip station comprises:

a recess defined in the disposable module housing configured to hold the first biological strip, and

a strip station cover removably connected to the disposable module housing, the strip station cover being configured to cover the recess and prevent access to the first biological strip when in a covered position and to permit access to the first biological strip when in an uncovered position.

19. The biological test kit of claim 13,

wherein the disposable module further comprises (v) a second strip station supported by the disposable module housing and including a second biological strip configured to receive a second biological sample and to provide the second biological sample to the measuring equipment for measurement of the property, and

wherein the measuring equipment comprises a correlation mechanism configured to identify a measured biological sample as having originated from the first strip station or the second strip station.

20. The biological test kit of claim 19, wherein the measuring equipment is configured to provide whether the measured biological sample originated from the first strip station or the second strip station to the display monitor for display.

21. The biological test kit of claim 13, wherein the biological test kit has an overall thickness of less than one centimeter.

22. The biological test kit of claim 13, wherein the reusable module further comprises (iv) a display monitor supported by the reusable module housing and configured to display the measured property.

23. The biological test kit of claim 13, wherein the reusable module further comprises (iv) a wireless transmitter supported by the reusable module housing and configured to transmit a signal representative of the measured property to a separate device for display.

24. The biological test kit of claim 13, wherein the reusable module further comprises (iv) a mobile device case connector supported by the reusable module housing and configured to detachably connect the reusable module to a mobile device case.

25. The biological test kit of claim 13, wherein the disposable module further comprises (iv) an insulin delivery device connector supported by the disposable module and configured to detachably connect the disposable module to an insulin delivery device.

26. A method of collecting a biological sample, comprising:

(a) providing a lancet device that includes (i) a base with a support surface, (ii) a lancet supported by the base and extending away from the support surface at an angle of approximately 90°

, and (iii) a cover with (A) a peripheral edge along which the cover is connected to the base, (B) a cover region with a cover region geometry, (C) a lancet aperture, and (D) a peripheral hinge near the peripheral edge, the peripheral hinge having a peripheral hinge geometry that differs from the cover region geometry;

(b) applying a predetermined force to the cover region, thereby moving the cover from an un-depressed position in which the cover region covers the lancet to a depressed position in which the lancet protrudes through the lancet aperture and exposes biological fluid; and

(c) collecting a quantity of the biological fluid as the biological sample.