System for withdrawing body fluid

• US 20060173379A1
• Filed: 01/17/2006
• Published: 08/03/2006
• Est. Priority Date: 07/16/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Schmelzeisen-Redeker, Gunter, Schmid, Wilfried, Schulat, Jochen, Pachl, Rudolf, Rasch-Menges, Jurgen
• Granted Patent: US 8,062,274 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/0257 Proximity sensors
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• 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 5/150175 Adjustment of penetration depth
• 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 5/150824 by visual feedback
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• 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
• CPC Class Codes: A61B 5/441 Skin evaluation, e.g. for skin disorder diagnosis
• CPC Class Codes: A61B 5/489 Blood vessels
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure

Abstract

The invention relates to a system for withdrawing body fluid from a body part via a withdrawal site located on the surface of the body part, with at least one sensor for detecting at least one variable dependent on the location or state of the withdrawal site, and with an evaluation unit for evaluating the at least one variable detected by the at least one sensor and for triggering a reaction, dependent on the value of the detected variable, in the system for withdrawing body fluid, said reaction serving to prepare the system for puncturing the surface of the body part, and with at least one puncturing device for creating an opening in the body at the withdrawal site. The invention further relates to an integrated analysis system, to a method for configuring a system for withdrawal of body fluid, and to a method for selecting a menu item from a menu for controlling a system for withdrawing body fluid from a body part.

Claims

1. A system for withdrawing body fluid from a body part via a withdrawal site located on the surface of the body part, the system comprising:

at least one sensor for detecting at least one variable dependent on the location or state of the withdrawal site;

an evaluation unit for evaluating the at least one variable detected by the at least one sensor and for triggering a reaction, dependent on the value of the detected variable, in the system for withdrawing body fluid, said reaction serving to prepare the system for the withdrawal of body fluid; and

at least one puncturing device for creating an opening in the body at the withdrawal site.

2. The system of claim 1, wherein the sensor comprises a sensor for detecting at least one of the variables of temperature, electrical resistance, electrical conductivity, electrical current strength, electrical voltage, position, inclination, pressure, acceleration, and optical variables.

3. The system of claim 1, wherein the sensor comprises a temperature sensor for detecting the skin temperature on the surface of the body part at the withdrawal site.

4. The system of claim 1, wherein the sensor comprises a sensor for detecting the electrical resistance or the electrical conductivity of skin on the surface of the body part at the withdrawal site.

5. The system of claim 1, wherein the sensor comprises a position or inclination sensor for detecting the position or inclination of the system upon contact with the withdrawal site.

6. The system of claim 1, wherein the sensor comprises a pressure sensor for detecting the pressure with which a press-on area of the system is applied to the surface of the body part at the withdrawal site.

7. The system of claim 1, wherein the sensor comprises an inductive, optical or capacitive proximity sensor for detecting the distance of the withdrawal site, located on the surface of the body part, from a press-on area of the system.

8. The system of claim 1, wherein the evaluation unit is adapted to trigger at least one of the following reactions dependent on the value of the at least one detected variable:

blocking or releasing of the at least one puncturing device;

setting the puncture depth of the puncturing device selected for creating the opening in the body;

setting the geometric shape of a press-on area of the system for withdrawing body fluid;

setting the cross section of an opening in a press-on area of the system for withdrawing body fluid, through which opening the puncturing device can penetrate into the surface of the body part;

selecting one of at least two press-on areas included in the system for withdrawing body fluid;

selecting one of at least two puncturing devices contained in the system for withdrawing body fluid;

setting the duration of the withdrawal procedure;

displaying text on a display device; and

displaying or setting evaluation parameters which are used by a device for analyzing the body fluid.

9. The system of claim 1, further comprising a compression unit for increasing the internal pressure in the area of the withdrawal site when collecting the body fluid.

10. The system of claim 1, wherein at least one sensor is arranged in a press-on area of the system for withdrawing body fluid.

11. An integrated analysis system comprising the system for withdrawing body fluid from a body part according to claim 1 and a device for analyzing at least one property of the body fluid.

12. The integrated analysis system of claim 11 wherein the system is adapted for withdrawing blood or interstitial fluid and for analyzing the glucose content in the blood or in the interstitial fluid.

13. A method for configuring a system for withdrawing body fluid from a body part via a withdrawal site, said method comprising the steps of:

measuring at least one variable dependent on the location and state of the withdrawal site; and

selecting a setting, which is dependent on the value of the measured variable and influences the withdrawal of body fluid, in the system for withdrawing body fluid.

14. The method of claim 13, wherein at least one of the following variables is measured:

temperature, electrical resistance, electrical conductivity, electrical current strength, electrical voltage, position, inclination, pressure, acceleration, and optical variables.

15. The method of claim 13, wherein at least one of the following settings is selected as a function of the value of the measured variable:

blocking or releasing of a puncturing device;

setting a puncture depth of a puncturing device selected for creating the opening in the body;

setting a geometric shape of a press-on area of the system for withdrawing body fluid;

setting the cross section of an opening in a press-on area of the system for withdrawing body fluid, through which opening a puncturing device can penetrate into the surface of the body part;

selecting one of at least two press-on areas included in the system for withdrawing body fluid;

selecting one of at least two puncturing devices contained in the system for withdrawing body fluid;

setting the duration of the withdrawal procedure;

displaying text on a display device; and

displaying or setting evaluation parameters which are used by a system for analyzing body fluid.

16. The method of claim 13, wherein the value of the measured variable is stored on a storage medium using GPS or radio-clock information.

17. A method for selecting a menu item in a system for controlling a system for withdrawing body fluid from a body part, said method comprising the steps of:

measuring one of the variables of temperature, electrical resistance, electrical conductivity, electrical current strength, electrical voltage, position, inclination, pressure, acceleration, or optical variables; and

selecting the menu item as a function of the value of the measured variable.