Handheld apparatus for creating a puncture wound

• US 8,394,117 B2
• Filed: 03/02/2008
• Issued: 03/12/2013
• Est. Priority Date: 09/03/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hein, Heinz-Michael, Calasso, Irio, List, Hans
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US12/040,905
• Publication Number:
  US 20080208079A1
• Time in Patent Office: 1,836 Days
• Field of Search: 600/583, 600/584, 606181-183, 606184-189, 606/171, 606/177, 835/84, 83/30
• US Class Current: 606/181
• 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 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• 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
• CPC Class Codes: Y10T 83/0481 Puncturing

Abstract

The invention relates to a method for creating a puncture wound for obtaining a sample of a body fluid from a body part in which a skin opening is created at a puncture site in the epidermis in a skin-opening step. Then, in a sample collection step a sample collection puncture is executed by using a puncture element with which the skin opening is deepened with the puncture element, thereby creating a puncture wound for obtaining the sample. The invention also relates to a handheld apparatus for implementing this method.

Claims

1. A handheld apparatus for creating a puncture wound in a body part having a layer of skin with an epidermis, the apparatus comprising:

a puncture element;

a drive for moving the puncture element toward and away from the skin;

a housing adapted to contact a body part and having an opening by which the puncture element can puncture the body part;

a control unit configured to automatically control movement of the puncture element, the control unit configured to automatically;

move the puncture element in a skin opening step a first distance toward the skin with the drive, whereby a skin opening may be created;

completely withdraw the puncture element from the body part at the end of the skin opening step; and

then

move the puncture element with the drive in a sample collection step toward the skin a second distance that is as great or greater than the first distance, whereby a puncture wound for collecting a sample may be created;

wherein, the movement of the puncture element in the skin opening step and the movement of the puncture element in the sample collection step comprise consecutive movements;

further wherein, the time interval between the time at which the puncture element is completely withdrawn from the body part at the end of the skin opening step and the time at which the puncture element first enters the body part during the sample collection step is 1 millisecond to 1 second, to thereby allow the epidermis at the skin opening to relax.

2. The apparatus of claim 1, wherein the control unit is operable to retract the puncture element before the step of moving the puncture element toward the skin the second distance.

3. The apparatus of claim 1, wherein:

the drive comprises a drive spring for generating a drive force and a drive rotor that is rotatingly driven by the drive force during operation of the apparatus;

the control unit comprising a curve control linked to the drive rotor; and

rotational movements of the drive rotor are converted through the control curve into movements of the puncture element toward and away from the skin.

4. The apparatus of claim 3, wherein the curve control comprises a control curve traveler which travels along a control curve of the drive rotor during a rotational movement of the drive rotor.

5. The apparatus of claim 4, wherein the control curve has a shape comprising a first extremum corresponding to the first distance and a second extremum corresponding to the second distance.

6. The apparatus of claim 4, wherein the control curve comprises an angle of rotation of the drive rotor of at least 360°

.

7. The apparatus of claim 4, wherein relaxing the spring results in a rotational movement of the drive rotor of more than 360°

.

8. The apparatus of claim 4, wherein the control curve is an open control curve.

9. The apparatus of claim 4, wherein, during relaxation of the drive spring, the drive rotor turns in a first direction of rotation and the drive spring is tensioned by the drive rotor when the drive rotor turns in a second direction of rotation, the second direction of rotation being opposite the first direction of rotation.

10. The apparatus of claim 1, further comprising a housing having a housing opening with a pressure ring for contacting to a body part in which a puncture wound is to be created, the puncture element being extendable through the pressure ring.

11. The apparatus of claim 1, wherein the lancet strokes resulting from moving the puncture element the first distance and the second distance are substantially the same.

12. The apparatus of claim 1, wherein the second distance is greater than the first distance.

13. The apparatus of claim 1, wherein the time interval is 1 millisecond to 30 milliseconds.

14. The apparatus of claim 1, further comprising a device which is operable to determine the position of the surface of the epidermis relative to a fixed reference point on the apparatus.

15. The apparatus of claim 1, wherein the control unit is operable to retract the puncture element into a collection position in which the tip of the puncture element remains within the skin.

16. The apparatus of claim 15, wherein the control unit is operable to decelerate the puncture element as the puncture element approaches the collection position.

17. The apparatus of claim 1, wherein movement of the puncture element through the first distance creates a skin opening having a depth of 0.4 mm to 2.0 mm.

18. The apparatus of claim 17, wherein movement of the puncture element through the first distance creates a skin opening having a depth of 0.8 mm to 1.2 mm.