Device for obtaining bodily fluids for analysis

• US 20080269639A1
• Filed: 03/14/2008
• Published: 10/30/2008
• Est. Priority Date: 09/15/2005
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Korner, Stephan, Calasso, Irio Giuseppe, Partel, Robert, Decker, Desiree
• Application Number:
  US12/048,798
• Publication Number:
  US 20080269639A1
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15119 comprising shape memory alloys
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads 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

Abstract

A lancing device for piercing skin to obtain a bodily fluid, such as blood, for testing has an electrically activated actuator, such as a shape memory alloy or electro-active polymer, that changes shape upon the application of electrical energy to advance and withdraw the lancing element. The lancing device operates when the actuator changes shape to advance a lancing element to pierce the skin when the actuator changes shape, delaying the lancing element tip near the advanced position to allow fluid to flow into the lancing tip, withdrawing the lancing element to remove the lancing element form the skin when the actuator again changes shape.

Claims

1. A device for obtaining bodily fluids for analysis, comprising:

a lancing element configured for insertion into a body;

a movement converter coupled to the lancing element to control movement of the lancing element;

a drive coupled to the lancing element and the movement converter to advance and withdraw the lancing element, the drive comprising,

an electrical source coupled to the drive to selectively apply electrical energy to the drive,

at least one actuator coupled to the electrical source, the actuator changes shape upon the application of electrical energy to advance the lancing element, and the actuator changes shape upon the removal of electrical energy to withdraw the lancing element.

2. The device as in claim 1, wherein the actuator is formed from a shape memory alloy that changes shape by contracting upon the application of electrical energy causing the shape memory alloy reaches a transformational temperature.

3. The device as in claim 1, wherein the actuator is formed from an electro-active polymer that changes shape by deformation upon the application of the electrical energy causing electrostatic attraction.

4. The device as in claim 1, further comprising,

a dampener coupled to the drive to maintain the lancing element in an advanced position briefly to allow for fluid flow into a lancing tip before the lancing element moves to a withdraw position.

5. The device as in claim 1, further comprising,

a return element coupled to the drive to aid in moving the lancing element from an advance position to a withdraw position.

6. The device as in claim 1, further comprising,

a trigger switch coupled to the electrical source to provide a current pulse to the actuator causing the actuator to change shape.

7. A device for obtaining bodily fluids for analysis, comprising:

a lancing element configured for insertion into a body part;

a movement converter coupled to the lancing element to control movement of the lancing element;

a drive coupled to the lancing element and the movement converter to advance and withdraw, the drive comprising,

at least one actuator wire composed of a shape memory alloy coupled to the movement converter,

a heating element thermally coupled to the actuator wire to contract the actuator wire when a transformational temperature is reached to advance the lancing element and expand when the transformational temperature is no longer reached to withdraw the lancing element.

8. The device as in claim 7, wherein the heating element is electrical energy selectively applied by an energy source.

9. The device as in claim 7, further comprising,

a trigger switch coupled to a capacitor to provide a current pulse as the heating element to the actuator wire to cause the actuator wire to reach the transformational temperature.

10. The device as in claim 9, further comprising,

movable electrical contact points that selectively engage the actuator wire to apply electrical energy to heat only the a selected portion of the actuator wire to adjust lancing depth.

11. The device as in claim 7, further comprising,

a dampener coupled to the drive to maintain the lancing element in an advanced position briefly to allow for fluid flow into a lancing tip before the lancing element moves to a withdraw position.

12. The device as in claim 7, further comprising,

a return element coupled to the drive to aid in moving the lancing element from being advanced to being withdrawn.

13. The device as in claim 7, wherein the actuator wire is a nickel-titanium alloy with a transformational temperate greater than 100 degrees Celsius.

14. The device as in claim 7, wherein the actuator wire has a diameter of 1 mm or less.

15. The device as in claim 7, wherein the lancing element is advanced at least an order of magnitude faster than the lancing element is withdrawn.

16. A device for obtaining bodily fluids for analysis, comprising:

a lancing element configured for insertion into a body part;

a movement converter coupled to the lancing element to control movement of the lancing element; and

,

a drive coupled to the lancing element and the movement converter to advance and withdraw the lancing element, the drive comprising,

means for electrical source coupled to the drive to selectively apply electrical energy to the drive,

means for actuation coupled to the electrical source, the means for actuation changing shape upon the selective application of electrical energy by the energy source to advance and withdraw the lancing element.

17. A method for operation of a lancing device to obtain bodily fluids for analysis, comprising:

positioning a lancing element in a withdrawn position;

applying electrical energy to an actuator that is coupled to the lancing element;

changing the shape of the actuator upon the application of the electrical source;

advancing the lancing element for insertion in response to the actuator changing shape;

tensioning a return spring coupled to the lancing element when the lancing element is advanced;

delaying the lancing element near the advance position to allow for fluid flow into a lancing element tip;

changing the shape of the actuator upon electrical energy no longer being applied to the actuator; and

,

withdrawing the lancing element upon the actuator changing shape and through force applied by the return spring.

18. The device as in claim 17, wherein the actuator is formed from a shape memory alloy that changes shape contracting upon the application of electrical energy causeing the actuator to reach a transformational temperature.

19. The device as in claim 17, wherein the actuator is formed from an electro-active polymer that changes shape by deformation upon the application of electrical energy causing electrostatic attraction.

20. A method for operating a lancing device to obtain bodily fluids for analysis, comprising:

positioning a lancing element in a withdrawn position;

heating an upper wire by a current pulse, the upper wire being coupled to the lancing element;

contracting the upper wire when a transformational temperature is reached;

advancing the lancing element for insertion in response to the upper wire contracting;

tensioning a return spring coupled to the lancing element when the lancing element is advanced;

delaying the lancing element near the advance position to allow for fluid flow into a lancing element tip;

cooling the upper wire when by absence of the current pulse;

expanding the upper wire when the transformational temperature is no longer reached; and

,

withdrawing the lancing element upon the upper wire expanding and the return spring tension.

21. The method as in claim 20, further comprising,

actuating a trigger switch coupled to a capacitor to provide the current pulse to the upper wire.