Lancing and analysis device

• US 8,858,467 B2
• Filed: 10/06/2009
• Issued: 10/14/2014
• Est. Priority Date: 04/18/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Haar, Hans-Peter
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US12/574,144
• Publication Number:
  US 20100256525A1
• Time in Patent Office: 1,834 Days
• Field of Search: 600/583, 600/584, 606181-186
• US Class Current: 600/584
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/150358 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 5/150389 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 5/150503 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 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A lancing device for generating a puncture wound in a body part to obtain a body fluid sample for analytical or diagnostic purposes, in particular, by using integrated disposables that comprise a lancing element as well as an associated test element is disclosed. In order to achieve a high success rate in obtaining the body fluid sample, a drive can be designed such that the lancing element or the test element can be moved into a contact position while remaining in a position near the body part contact opening during a deployment period. If the amount of sample obtained in a lancing movement is inadequate to carry out the analysis or diagnosis, the lancing element can be brought into contact with the sample by a user by manual positioning the lancing device to manually take up a sample obtained by manually milking the sampling site in the region of the puncture wound.

Claims

1. A lancing device for generating a puncture wound in the skin of a human or animal to obtain a sample of a body fluid with a first analytical consumable which comprises a lancing element for carrying out an analysis of a medically significant component of the sample with a second analytical consumable which comprises a test element, wherein the lancing device comprises:

a pressing member for pressing the lancing device against a body part in which it is intended to generate a puncture wound with the lancing element at a sampling site from which a sample is to be taken;

a drive for driving a lancing element inserted into the lancing device for a lancing movement of the lancing element along a predetermined lancing path into a lancing position, wherein the lancing movement comprises a rapid puncture movement which is directly followed by a return movement;

a housing with a body part contact opening for the body part, wherein the lancing element is disposed in the housing in an initial position and at the body part contact opening it can be pierced into the applied body part in the lancing position by actuating the drive; and

a control device configured for checking a collected sample with regard to whether the amount of sample obtained and taken up by the lancing device is sufficient for carrying out the analysis with a test element,

wherein the drive is configured such that in a first step the lancing movement can be carried out with a lancing element to generate a puncture wound at a sampling site for obtaining a sample, and wherein the lancing device is configured such that after the lancing movement the control device can be used to check whether the amount of sample obtained and taken up by the lancing device is sufficient to carry out the analysis with a test element, and

wherein the drive is configured such that in a further step at least one of the analytical consumables can be moved in an extending movement into a contact position in which the analytical consumable remains in a position in the region of the body part contact opening during a deployment period, in which the analytical consumable can be brought into contact with the sample by a user of the lancing device by a manual positioning of the lancing device to manually take up a sample which has been expressed by manually milking the sampling site in the region of the puncture wound, if according to the result of the check carried out by the control device, the amount of sample obtained in the lancing movement is not sufficient to carry out the analysis,

and wherein the extending movement differs from the puncture movement in that the analytical consumable remains in the contact position for a longer time than in the lancing position such that in the contact position it can be brought into contact with the sample by the user of the lancing device during the deployment period by a manual positioning of the lancing device to manually take up a sample which has been expressed by manually milking the sampling site in the region of the puncture wound.

2. The lancing device according to claim 1, wherein the at least one analytical consumable protrudes from an exit opening of the lancing device during the deployment.

3. The lancing device according to claim 1, wherein the contact position of the analytical consumable in the further step of the extending movement is different from the lancing position of the first step of the lancing movement.

4. The lancing device according to the claim 1, wherein the analytical consumable is moved further towards the sampling site or further out of the lancing device in the extending movement than in the lancing movement.

5. The lancing device according to claim 1, wherein the at least one analytical consumable moved into the contact position in the further step is an analytical consumable comprising a lancing element or a test element or an integrated disposable which comprises a lancing element for carrying out the puncture to obtain the body fluid sample as well as a test element to carry out the analysis of a medically significant component of the body fluid sample.

6. The lancing device according to claim 1, wherein the first analytical consumable and the second analytical consumable are integrated in an integrated disposable comprising a lancing element for carrying out the puncture process to obtain the body fluid sample and a test element for carrying out the analysis of a medically significant component of the body fluid sample.

7. The lancing device according to claim 1, wherein the control device has a visual check of the amount of body fluid sample by the user.

8. The lancing device according to claim 1, wherein the control device comprises an automatic sample quantity detection device or underdosing detection device.

9. The lancing device according to claim 1, further comprising,

an automatic operating mode carries out the first step of a lancing movement;

and

a manual operating mode initiates the further step of a lancing, if the result of the check performed by the control device indicates an insufficient amount of body fluid sample obtained in the previous lancing movement to carry out the analysis.

10. The lancing device according to claim 1, wherein the at least one analytical consumable can be moved into the contact position by the drive if an inadequate amount of body fluid sample is detected by the first step of a lancing movement.

11. The lancing device according to claim 10, wherein the control device further comprises,

a signal unit for signaling to the user an inadequate amount of body fluid sample for carrying out the analysis.

12. The lancing device according to claim 10, wherein the control device further comprises, automatically moving the at least one analytical consumable into the contact position when the control device detects an insufficient amount of body fluid sample for carrying out the analysis.

13. The lancing device according to claim 1, wherein the lancing element can be moved into the initial or standby position to carry out a subsequent puncture operation with the lancing element if the check whether the amount of body fluid sample obtained is sufficient indicates that the amount of body fluid sample is not sufficient to carry out the analysis.

14. The lancing device according to claim 1, wherein the subsequent puncture process is carried out with an increased puncture depth.