Lancing and analysis device

• US 20100256525A1
• Filed: 10/06/2009
• Published: 10/07/2010
• Est. Priority Date: 04/18/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: List, Hans, Haar, Hans-Peter
• Granted Patent: US 8,858,467 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 a body part to obtain a body fluid sample with a first analytical consumable, the first analytical consumable comprising a lancing element for carrying out an analysis of a medically significant component of the sample with a second analytical consumable comprising a test element, the lancing device comprising:

a pressing member for pressing the lancing device against the body part at a sampling site;

a housing comprising a body part contact opening in contact the body part, wherein the lancing element is disposed within the housing in an initial position and in proximity of the body part contact opening;

a control device for checking whether an amount of the obtained body fluid sample is sufficient for carrying out the analysis with the test element after a lancing movement; and

a drive for driving the lancing element in the lancing movement along a predetermined lancing path into a lancing position, wherein the lancing movement comprises a rapid puncture movement directly followed by a return movement, wherein a first step of the lancing movement comprises generating a puncture wound at the sampling site for obtaining the body fluid sample and wherein a further step of the lancing movement comprises moving at least one of the analytical consumables in an extending movement into a contact position if the result of the control device check indicates an insufficient amount of body fluid sample to carry out the analysis, the at least one of the analytical consumables remains in a position near the body part contact opening during a deployment period, wherein the at least one of the analytical consumables can be brought into contact with the body fluid sample by a user by manual positioning the lancing device to manually take up the body fluid sample obtained by manually milking the sampling site in the region of the puncture wound;

wherein the extending movement differs from the rapid puncture movement in that the analytical consumable remains longer in the contact position than in the lancing position, and wherein when in the contact position, the analytical consumable is brought into contact with the body fluid sample by the user during the deployment period.

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.

15. A hand-held analysis device for analyzing a medically significant component of a body fluid sample, the hand-held device comprising:

a lancing device according comprising,

a pressing member for pressing the lancing device against the body part at a sampling site;

a housing comprising a body part contact opening in contact the body part, wherein the lancing element is disposed within the housing in an initial position and in proximity of the body part contact opening;

a control device for checking whether an amount of the obtained body fluid sample is sufficient for carrying out the analysis with the test element; and

a drive for driving the lancing element in a lancing movement along a predetermined lancing path into a lancing position, wherein the lancing movement comprises a rapid puncture movement directly followed by a return movement, wherein a first step of the lancing movement comprises generating a puncture wound at the sampling site for obtaining the body fluid sample and wherein a further step of the lancing movement comprises moving at least one of the analytical consumables in an extending movement into a contact position if the result of the control device check indicates an insufficient amount of body fluid sample to carry out the analysis, the at least one of the analytical consumables remains in a position near the body part contact opening during a deployment period, wherein the at least one of the analytical consumables can be brought into contact with the body fluid sample by a user by manual positioning the lancing device to manually take up the body fluid sample obtained by manually milking the sampling site in the region of the puncture wound; and

an analysis apparatus for carrying out an analysis or diagnosis using the body fluid sample obtained by the lancing device, wherein the analysis apparatus is integrated into the hand-held analysis device.

16. A method for preparing a lancing device for manually taking up a body fluid sample by an analytical consumable in a contact position in which the analytical consumable remains in a position in the region of a body part contact opening during a deployment period in which it can be brought into contact with the body fluid sample by a user by manual positioning the lancing device for a manual uptake of a body fluid sample obtained in the region of a puncture wound, wherein the lancing device is provided for carrying out an analysis of a medically significant component of a sample and wherein the lancing device generates a puncture wound in a body part for obtaining the body fluid sample for analytical or diagnostic purposes using a first analytical consumable comprising a lancing element and for carrying out an analysis of a medically significant component of the body fluid sample using a second analytical consumable comprising a test element, wherein the lancing device comprises,

a pressing member for pressing the lancing device against the body part at a sampling site;

a housing comprising a body part contact opening in contact the body part, wherein the lancing element is disposed within the housing in an initial position and in proximity of the body part contact opening;

a control device for checking whether an amount of the obtained body fluid sample is sufficient for carrying out the analysis with the test element after a lancing movement; and

a drive for driving the lancing element in the lancing movement along a predetermined lancing path into a lancing position, wherein the lancing movement comprises a rapid puncture movement directly followed by a return movement, wherein a first step of the lancing movement comprises generating a puncture wound at the sampling site for obtaining the body fluid sample and wherein a further step of the lancing movement comprises moving at least one of the analytical consumables in an extending movement into a contact position if the result of the control device check indicates an insufficient amount of body fluid sample to carry out the analysis, the at least one of the analytical consumables remains in a position near the body part contact opening during a deployment period, wherein the at least one of the analytical consumables can be brought into contact with the body fluid sample by a user by manual positioning the lancing device to manually take up the body fluid sample obtained by manually milking the sampling site in the region of the puncture wound;

wherein the extending movement differs from the rapid puncture movement in that the analytical consumable remains longer in the contact position than in the lancing position, and wherein when in the contact position, the analytical consumable is brought into contact with the body fluid sample by the user during the deployment period.