Unitized Painfree Blood Glucose Measuring Device

• US 20090221893A1
• Filed: 02/27/2009
• Published: 09/03/2009
• Est. Priority Date: 02/29/2008
• Status: Abandoned Application

• Current Assignee: Path Scientific, LLC
• Original Assignee: Path Scientific, LLC
• Inventors: Herndon, Terry O.
• Application Number:
  US12/394,139
• Publication Number:
  US 20090221893A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150236 Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• 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 5/15109 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 5/15123 comprising magnets or solenoids
• 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 blood glucose measuring device is equipped with a drill device, attachment assembly, and disposable sensing and measurement assembly. The attachment assembly contains an attachment ring that connects to the drill device and is used to hold the disposable sensing and measurement assembly. A detach actuating cam and output shaft are attached to the drill device. Spring tongs are attached to the output shaft by a compression ring further clamp to an end cap. A skin penetrator is attached to the end cap. The disposable sensing and measurement assembly is enclosed in a disposable case. An outer telescoping anti-bend tube is attached to the end cap. An inner anti-bend capillary sensor tube contains analyte sensors and is attached to the disposable case. The electrical conductors for the analyte sensor electrodes are attached to the capillary sensor tube and thus to the disposable case. An impedance sensing electrode on the bottom of the case provides electrical contacts to the skin. The electrical conductor to the impedance sensing electrode is attached to the bottom of the disposable case.

Claims

1. A unitized pain-free blood glucose measuring device comprising:

a drill device;

an attachment assembly; and

a disposable sensing and measurement assembly;

wherein the drill device comprises a vertical drive motor to raise and lower an output shaft and further comprises;

electronics to control the vertical driver motor;

contacts for analyte sensing and impedance sensing electrodes;

a read-out to display analyte concentration;

electrical conductors in contact with impedance sensing electrodes in a disposable sensing and measurement assembly;

electrical conductors in contact with analyte sensing electrodes in the disposable sensing and measurement assembly; and

wherein the attachment assembly has a top and bottom, and the output shaft has an upper and lower end and the top of the attachment assembly contacts the drill device at the upper end of the output shaft;

wherein the attachment assembly further includes an assembly attachment ring;

wherein the disposable sensing and measurement assembly is enclosed in a disposable case;

wherein the disposable sensing and measurement assembly has a top and bottom wherein the top is removably attached to the drill device by means of the attachment assembly;

wherein the disposable sensing and measurement assembly further comprises;

an impedance sensing electrode in communication with the electrical contacts in the drill device by means of the assembly attachment ring;

analyte sensor and analyte sensing electrodes in communication with the electrical contacts in the drill device by means of the assembly attachment ring;

an end cap with a top and bottom, wherein the top is attached to the lower end of the output shaft;

a skin penetrator with a puncture end and driver end, wherein the driver end is attached to the bottom of the end cap;

an outer telescoping, anti-bend tube with a top and bottom, wherein the top end is connected to the bottom of the end cap and the tube is centrally positioned around the skin penetrator;

an inner anti-bend capillary sensor tube with a top and bottom,

wherein the top of the inner sensor tube telescopes into the bottom of the outer telescoping, anti-bend tube and the tube is centrally located around the skin penetrator; and

wherein the bottom of the inner anti-bend capillary sensor tube is attached to the bottom of the disposable case.

2. The unitized blood glucose measuring device of claim 1, wherein the analyte sensor and sensing electrodes are disposed within the inner anti-bend capillary sensor tube.

3. The unitized blood glucose measuring device of claim 1, wherein the impedance sensing electrode is an electrically conducting member peripherally located around a centrally located recess on the bottom of the disposable case.

4. The unitized blood glucose measuring device of claim 1, wherein the end cap has grooved sides.

5. The unitized blood glucose measuring device of claim 4, further comprising a pair of spring-loaded, outside telescoping, anti-bend tube withdrawal tongs with a first and second end, wherein the second end can clamp to the grooved sides of the end cap.

6. The unitized blood glucose measuring device of claim 5 further comprising a skin penetrator detaching cam with a top and bottom side, wherein the top side is attached to the drill device and the bottom side is removably attached to the first end of the withdrawal tongs.

7. The unitized blood glucose measuring device of claim 1, wherein the vertical drive motor is in communication with the output shaft and further comprises electronic control circuits in communication with the drive motor and electrical contacts on the disposable sensing and measurement assembly.

8. The unitized blood glucose measuring device of claim 7, wherein the vertical drive motor is a stepping motor.

9. The impedance sensing assembly of claim 8, wherein the electronic control circuits further comprise:

a control mechanism that starts the stepper motor;

a control mechanism that starts counting steps once the electrical impedance between the skin penetrator and the impedance sensing electrode reaches a preset trigger impedance value;

a control mechanism that stops the stepper motor once a pre-set step count is reached;

a control mechanism to control a forward motion rate adjustment capability;

a control mechanism to control a reverse rate adjustment capability; and

a control mechanism to control an end of reverse motion trigger that will stop the cycle and pre-set the system for the next forward cycle.

10. The unitized blood glucose measuring device of claim 1, wherein the skin penetrator is a stiff, hard wire or fluted shaft of electrically conducting material such as, but not limited to, tungsten or stainless steel.

11. The unitized blood glucose measuring device of claim 10, wherein the skin penetrator is coated with a blood wetting material to help draw out fluid behind it as it is withdrawn.

12. The unitized blood glucose measuring device of claim 1, wherein the skin penetrator is an acupuncture needle.

13. The unitized blood glucose measuring device of claim 12, wherein the skin penetrator is coated with a blood wetting material to help draw out fluid behind it as it is withdrawn.

14. The unitized blood glucose measuring device of claim 1, wherein a self-aligned petal arrangement of from 3 to 6 protruding petals is attached to the disposable case as an alignment aid.

15. The unitized blood glucose measuring device of claim 1, wherein the output shaft is rotated by a motorized drive and the rotation is controlled by electronics in the drill device.

16. The unitized blood glucose measuring device of claim 1, wherein the inner anti-bend capillary sensor tube is made up of two or more concentric layers.

17. The unitized blood glucose measuring device of claim 16, wherein one or more of the layers contain electrodes;

wherein the electrodes are in communication with electrical contacts in the drill device by means of the assembly attachment ring.

18. A method of unitized, painless measurement of blood glucose using the unitized blood glucose measuring device of claim 5, comprising the steps of:

attaching the sensing and measurement assembly to the drill device;

setting a preset trigger impedance and a preset step count;

pressing the sensing and measurement assembly against the skin of a user;

activating the skin penetrator to move toward the skin;

starting the step count once the impedance between the skin penetrator and the impedance sensing electrode reaches the preset trigger impedance value;

moving the skin penetrator into the skin to a predetermined step count and stopping;

withdrawing the skin penetrator and allowing fluid to accumulate into the inner capillary sensor tube and contacting analyte sensor and electrodes located therein;

sensing analyte with the analyte sensor and transmitting an electrical signal to the electrical contacts; and

displaying an analyte concentration value to the user.

19. The method of claim 18, further comprising the steps of:

withdrawing the skin penetrator until the output shaft reaches an end position and stops;

releasing the spring-loaded, outer telescoping, anti-bend tube withdrawal tongs holding the end cap; and

removing the disposable sensing and measurement assembly and pulling it away from the unitized blood glucose measuring device.

20. The method of claim 19, further comprising the step of attaching a new sensing and measurement assembly to the drill device.

21. The method of claim 20, wherein the skin penetrator is inserted at a rate of speed of about 0.0125 inches per 0.1 seconds.

22. The method of claim 20, wherein the skin penetrator is retracted at a rate of speed of about 0.0125 inches in from 10 to 30 seconds.

23. A blood glucose measuring device comprising

(a) a drill device,

(b) an attachment assembly, and

(c) a disposable sensing and measurement assembly;

wherein the attachment assembly contains an attachment ring that connects to the drill device and is used to hold the disposable sensing and measurement assembly;

(d) a detach actuating cam and output shaft are attached to the drill device;

(e) spring tongs are attached to the output shaft by a compression ring further clamp to an end cap;

(f) a skin penetrator is attached to the end cap;

(g) the disposable sensing and measurement assembly is enclosed in a disposable case;

(h) an outer telescoping anti-bend tube is attached to the end cap;

(i) an inner anti-bend capillary sensor tube contains analyte sensors and is attached to the disposable case;

(j) electrical conductors for the analyte sensor electrodes are attached to the capillary sensor tube and thus to the disposable case;

(k) an impedance sensing electrode on the bottom of the case provides electrical contacts to the user'"'"'s skin; and

(l) an electrical conductor to the impedance sensing electrode is attached to the bottom of the disposable case.