Systems for withdrawing body fluid and methods for configuring systems for withdrawing body fluids

• US 9,456,782 B2
• Filed: 10/13/2011
• Issued: 10/04/2016
• Est. Priority Date: 07/16/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Schmelzeisen-Redeker, Gnter, Rasch-Menges, Jrgen, Schulat, Jochen, Schmid, Wilfried, Pachl, Rudolf
• Primary Examiner(s): Vasat, Peter S
• Application Number:
  US13/272,734
• Publication Number:
  US 20120035504A1
• Time in Patent Office: 1,818 Days
• Field of Search: 604/289, 604/290, 604/540, 600/504, 600/578
• US Class Current: 1/1
• 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 method for configuring a system for withdrawing body fluid from a body part via a withdrawal site, comprising:

measuring a value of at least one variable dependent on the location and state of the withdrawal site by using a sensor, wherein at least one of the following variables is measured;

temperature, electrical resistance, electrical conductivity, electrical current strength, electrical voltage, position, inclination, pressure, acceleration, or optical variables;

selecting a setting, which is dependent on the value of the measured variable to thereby influence the withdrawal of body fluid, in the system wherein the setting is selected dependent on the value of the measured at least one variable and by the selection of the setting the system for withdrawing body fluid is automatically adapted to withdrawal conditions before skin at the withdrawal site is punctured;

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, wherein the releasing of the puncturing device is bringing the puncturing device into a state ready for activation;

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

setting a geometric shape of a press-on area of the system;

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

selecting one of at least two press-on areas included in the system;

selecting one of at least two puncturing devices contained in the system;

setting a duration of a body fluid withdrawal procedure;

displaying text on a display device;

or

displaying or setting evaluation parameters which are used by the system for analyzing body fluid; and

wherein the value of the measured variable is stored on a storage medium using GPS or radio-clock information.

2. The method of claim 1, wherein the sensor comprises at least one of the following sensors:

a pressure sensor, a proximity sensor, a resistance sensor, or a conductivity sensor, wherein the setting comprises a blocking or releasing of a puncturing value of the variable detected by the pressure sensor, the proximity sensor, the resistance sensor or the conductivity sensor indicates that the withdrawal site of the body part is pressed with sufficient or insufficient pressure onto a compression unit.

3. The method of claim 1 wherein the withdrawal conditions are selected from the group consisting of skin temperature, shape of the body part, thickness of the skin and contact pressure of the body part.

4. The method of claim 1, wherein the system comprises a compression unit for increasing an internal pressure in the area of the withdrawal site when collecting the body fluid, in such a way that body fluid is expressed out of the opening, wherein said compression unit converts pressure exerted in a primary direction into a movement into a secondary direction so that the internal pressure in an area of the body part is increased.

5. A method for selecting a menu item from a menu in a system for controlling a system for withdrawing body fluid from a body part, comprising:

measuring a value of one or more variables including temperature, electrical resistance, electrical conductivity, electrical current strength, electrical voltage, position, inclination, pressure, acceleration, or optical variables, the variables corresponding to the location and state of the withdrawal site; and

selecting the menu item from the menu as a function of the value of the measured variable, wherein the menu item may be at least one of;

blocking or releasing of a puncturing device, wherein the releasing of the puncturing device is bringing the puncturing device into a state ready for activation;

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

setting a geometric shape of a press-on area of the system;

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

selecting one of at least two press-on areas included in the system;

selecting one of at least two puncturing devices contained in the system;

setting a duration of a body fluid withdrawal procedure;

displaying text on a display device;

or

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

6. The method of claim 5 wherein the value of the measured variable is stored on a storage medium using GPS or radio-clock information.

7. A method for configuring a system for withdrawing body fluid from a body part via a withdrawal site, comprising:

measuring a value of at least one variable dependent on the location and state of the withdrawal site by using a sensor, wherein at least one of the following variables is measured;

temperature, electrical resistance, electrical conductivity, electrical current strength, electrical voltage, position, inclination, pressure, acceleration, or optical variables;

selecting a setting, which is dependent on the value of the measured variable to thereby influence the withdrawal of body fluid, in the system wherein the setting is selected dependent on the value of the measured at least one variable and by the selection of the setting the system for withdrawing body fluid is automatically adapted to withdrawal conditions before skin at the withdrawal site is punctured;

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, wherein the releasing of the puncturing device is bringing the puncturing device into a state ready for activation;

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

setting a geometric shape of a press-on area of the system;

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

selecting one of at least two press-on areas included in the system;

selecting one of at least two puncturing devices contained in the system;

setting a duration of a body fluid withdrawal procedure;

displaying text on a display device;

or

displaying or setting evaluation parameters which are used by the system for analyzing body fluid; and

wherein the system comprises a compression unit for increasing an internal pressure in the area of the withdrawal site when collecting the body fluid, in such a way that body fluid is expressed out of the opening, wherein said compression unit converts pressure exerted in a primary direction into a movement into a secondary direction so that the internal pressure in an area of the body part is increased.

8. The method of claim 7, wherein the sensor comprises at least one of the following sensors:

a pressure sensor, a proximity sensor, a resistance sensor, or a conductivity sensor, wherein the setting comprises a blocking or releasing of a puncturing device when the variable detected by the pressure sensor, the proximity sensor, the resistance sensor or the conductivity sensor indicates that the withdrawal site of the body part is pressed with sufficient or insufficient pressure onto a compression unit.

9. The method of claim 7, wherein the withdrawal conditions are selected from the group consisting of skin temperature, shape of the body part, thickness of the skin and contact pressure of the body part.