Device for positioning a body part for fluid analysis

• US 8,376,959 B2
• Filed: 11/21/2006
• Issued: 02/19/2013
• Est. Priority Date: 05/21/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Deck, Frank
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Pani, John
• Application Number:
  US11/562,242
• Publication Number:
  US 20070100365A1
• Time in Patent Office: 2,282 Days
• Field of Search: 600/573, 600/583, 606181-185, 606201-204
• US Class Current: 600/573
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150748 Having means for aiding positioning of the piercing device at a location where the body is to be pierced means for aiding positioning of devices for bringing media into the body A61M5/427, locating blood vessels A61B5/489
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A device and a method are disclosed for positioning a body part (16) on an analytical device (14) for body fluids includes a flexible compression element (24) for pressing against the body part (16) while increasing the pressure and a rigid support part (26) to hold the compression element (24) on a housing (12) of the analytical device (14). The compression element (24) has an engaging member (34) for the body part (16) which can be pressed into the housing (12) such that a withdrawal region (56) of the body part (16) is exposed in the interior (18) of the housing (12) in order to remove liquid.

Claims

1. An analytical instrument for body fluids and for determining blood sugar, the analytical instrument comprising a housing and a device for positioning a body part, the device comprising a circular flexible compression element for pressing against the body part while increasing pressure and a rigid support part to hold the compression element on the housing, wherein the compression element has an engaging member for the body part, the compression element can be pressed into the housing during liquid withdrawal such that a withdrawal region of the body part is exposed in an interior of the housing opposite to a flat test field;

wherein the compression element is permanently connected at a connecting area to a rim of an opening in the support part;

wherein the rim has a height;

wherein the connecting area extends over the entire height of the rim of the opening;

wherein the support part has a top surface and a bottom surface facing the interior of the housing, wherein the rim height extends from the top surface to the bottom surface;

wherein the connecting area of the compression element is permanently connected to the rim over the entire height of the rim; and

wherein the compression element can move past the bottom surface when pressed.

2. The analytical instrument of claim 1, further comprising a test tape that is arranged in the interior of the housing, the test tape having a plurality of test fields on a windable support tape.

3. The analytical instrument of claim 2, characterized in that the test fields arranged consecutively on the test tape that is located in a cassette can be moved successively into an active position with regard to the withdrawal region of the body part, and/or a lancing device and/or an analytical device by means of a tape transport device.

4. The analytical instrument of claim 1, further comprising a lancing device for insertion into the withdrawal region of the body part is arranged in the interior of the housing.

5. The analytical instrument of claim 4, characterized in that the lancing device has a distal pressing face to press a test field against the withdrawal region of the body part.

6. The analytical instrument of claim 1, further comprising an analytical device for detecting an analyte on a test field to which body fluid has been applied, which is arranged in the interior of the housing.

7. The analytical instrument of claim 1, characterized in that a receiving area of the test field to which body fluid can be applied is more than 2 ×

5 mm².

8. The analytical instrument of claim 1, characterized in that a receiving area of the test field to which body fluid can be applied is 5 ×

20 mm².

9. The analytical instrument of claim 1, further comprising a stop means to limit pressing depth of the compression element.

10. The analytical instrument of claim 1, characterized in that the compression element with a circular cross-section has a free outer edge that is widened by an outwardly projecting stop bead.

11. The analytical instrument of claim 10, characterized in that the stop bead tapers in a wedge-like manner away from the free outer edge of the compression element.

12. The analytical instrument of claim 1, characterized in that the compression element has two subregions which converge in a conical manner towards a pressure axis wherein a distal subregion has a stop bead on the outside of the compression element which abuts against a proximal subregion when the compression element is pressed against the body part.

13. The analytical instrument of claim 1, wherein the support part has an opening, wherein the compression element can be pressed into the opening, the instrument further comprising:

an abutment extending into an area of an opening region is attached to a housing side of the support part in order to limit depth of impression of the compression element.

14. The analytical instrument of claim 13, characterized in that the abutment is formed by a stop ring which tapers into the opening of the support part.

15. The analytical instrument of claim 1, characterized in that the connecting area is inclined away from a boundary surface of the support part on the housing where the angle between the incline and the boundary surface is in the range of 50°

to 70°

.

16. The analytical instrument of claim 15, characterized in that the angle between the incline and the boundary surface is 60°

.

17. The analytical instrument of claim 1, characterized in that the compression element in an initial position has an inner surface which tapers in a kink-free manner towards a lateral edge of the support part on the housing.

18. The analytical instrument of claim 1, characterized in that the engaging member is formed by an inner edge of a concavely curved ring surface of the compression element.

19. The analytical instrument of claim 1, characterized in that the compression element is molded as a molded part onto the support part.

20. The analytical instrument of claim 1, characterized in that the compression element consisting of a thermoplastic elastomer and the support part consisting of plastic are formed as a two component injection molded part.

21. The analytical instrument of claim 1, characterized in that the compression element is attached to the support part by an adhesive bond.

22. The analytical instrument of claim 21, wherein the adhesive bond includes a primer.

23. The analytical instrument of claim 1, characterized in that the compression element is composed of silicon, rubber or polyurethane.

24. The analytical instrument of claim 1, characterized in that the support part is constructed as a dimensionally stable ring washer made of metal.

25. The analytical instrument of claim 1, characterized in that the support part can be inserted into a housing receiving member in a detachable manner.

26. The analytical instrument of claim 1, characterized in that a total width of the support part perpendicular to a pressing direction is less than 25 mm.

27. The analytical instrument of claim 26, characterized in that the total width of the support part perpendicular to the pressing direction is less than 20 mm.

28. An analytical instrument, comprising:

a housing having an interior;

a circular flexible compression element having a distal subregion and a proximal subregion, the distal subregion and the proximal subregion converging in a conical manner to form an open engaging member, the open engaging member being configured to engage a finger;

a rigid support part holding the circular flexible compression element on the housing, the rigid support part defining an opening with a rim around the opening, the rim having a height, and the rigid support part having a bottom surface that faces the interior of the housing;

the proximal subregion being permanently connected at a connecting area to the rim of the rigid support part;

the connecting area extending over the entire height of the rim of the rigid support part to shift a bending site of the flexible compression element towards the rim of the rigid support part so that the engaging member of the circular compression element moves past the boundary surface of the rigid support part when the finger is pressed against the circular flexible compression element to expose the finger to the interior of the housing;

wherein the rigid support part is a ring washer made of metal;

wherein the compression element is made of silicone;

wherein the rigid support part has a top surface, wherein the rim height extends from the top surface to the bottom surface; and

wherein the connecting area of the compression element is permanently connected to the rim over the entire height of the rim.

29. The analytical instrument of claim 28, wherein the connecting area is inclined away from the boundary surface of the rigid support part at an angle in a range of 50°

to 70°

.

30. The analytical instrument of claim 28, wherein:

the distal subregion having a free outer edge that tapers in a wedge-shaped manner towards the proximal subregion;

the proximal subregion having an outer side; and

the circular flexible compression element having a stop bead on the free outer edge of the distal subregion, the stop bead being configured to brace against the outer side of the proximal subregion to limit further collapse of the circular flexible compression element.

31. The analytical instrument of claim 28, further comprising:

an abutment attached to the boundary surface of the rigid support part; and

the abutment having a beveled surface that extends inwards to create a locking support with the proximal subregion when the circular flexible compression element is pressed by the finger to enhance positional accuracy of the finger.

32. The analytical instrument of claim 28, further comprising:

a test tape disposed in the interior of the housing, the test tape being configured to receive body fluid from the finger when the finger is pressed against the circular flexible compression element.

33. An analytical instrument, comprising:

a housing having an interior and a boundary surface facing the interior;

a circular flexible compression element having a distal subregion and a proximal subregion, the distal subregion and the proximal subregion converging in a conical manner to form an open engaging member, the open engaging member being configured to engage a finger;

a rigid support part holding the circular flexible compression element on the housing, the rigid support part having a bottom surface that faces the interior of the housing and a top surface located opposite the bottom surface, wherein the rigid support part has a height extending from the bottom surface to the top surface;

the proximal subregion being permanently connected at a connecting area to the rigid support part;

the connecting area extending over the height of the rigid support part to shift a bending site of the flexible compression element towards the rigid support part so that the engaging member of the circular compression element moves past the boundary surface of the housing when the finger is pressed against the circular flexible compression element to expose the finger to the interior of the housing;

the connecting area being inclined away from the boundary surface of the rigid support part at an angle in a range of 50°

to 70°

;

the distal subregion having a free outer edge that tapers in a wedge-shaped manner towards the proximal subregion;

the proximal subregion having an outer side;

the circular flexible compression element having a stop bead on the free outer edge of the distal subregion, the stop bead being configured to brace against the outer side of the proximal subregion to limit further collapse of the circular flexible compression element;

an abutment attached to the boundary surface of the rigid support part; and

the abutment having a beveled surface that extends inwards to create a locking support with the proximal subregion when the circular flexible compression element is pressed by the finger to enhance positional accuracy of the finger.

34. An analytical instrument for body fluids and for determining blood sugar, the analytical instrument comprising:

a housing having an interior and a boundary surface facing the interior; and

a device for positioning a body part, the device including

a circular flexible compression element for pressing against the body part while increasing pressure, and

a rigid support part to hold the compression element on the housing, wherein the support part has a top surface and a bottom surface, wherein the support part has a height that extends from the top surface to the bottom surface, wherein the entire connecting area of the compression element is permanently connected to the support part over the entire height of the support part, wherein the compression element has an engaging member for the body part, the engaging member can be pressed into the housing to a stop position under the boundary surface of the housing, where a pressing depth of the compression element is limited by a stop, such that a withdrawal region of the body part is exposed in the interior of the housing opposite to a flat test field in order to remove liquid.