Analytical device with lancet and test element

• US 7,396,334 B2
• Filed: 08/29/2002
• Issued: 07/08/2008
• Est. Priority Date: 08/29/2001
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Forster, Richard, Fritz, Michael, Weiss, Thomas, Kuhr, Hans-Juergen
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): Mendoza; Michael G.
• Application Number:
  US10/230,851
• Publication Number:
  US 20030050573A1
• Time in Patent Office: 2,140 Days
• Field of Search: 606/167, 606/181, 606/182, 606/183, 600/583, 600/573, 600/576, 600/577, 600/578, 600/584
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• 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 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150312 Sterilisation of piercing elements, piercing devices or sampling devices piercing element stocking means, e.g. cartridges, A61B5/15176
• CPC Class Codes: A61B 5/150335 by radiation
• 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 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150534 Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15058 Joining techniques used for protective means
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• 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: Y10T 29/49826 Assembling or joining

Abstract

The invention concerns an analytical device containing a lancet comprising a lancet needle and a lancet body, the lancet needle being movable relative to the lancet body and the lancet body being composed, at least in the area of the tip of the lancet needle, of an elastic material in which the tip of the lancet needle is embedded, and an analytical test element which is permanently connected to the lancet body. In addition the invention concerns an analytical device containing a lancet comprising a lancet needle and a lancet body which is in the form of a hollow body in the area of the tip of the lancet needle and surrounds the tip of the lancet needle, the lancet needle being movable relative to the lancet body and the hollow body being composed at least partially of an elastic material, and an analytical test element which is permanently connected to the lancet body. Finally the invention concerns a process for manufacturing such an analytical device.

Claims

1. Analytical device containing

i) a lancet comprising

a lancet needle with a tip and

a lancet body which is in the form of a hollow body in the area of the tip of the lancet needle and which surrounds the tip of the lancet needle, the lancet needle being movable relative to the lancet body and the hollow body being composed at least partially of a material that can be pierced by the tip of the lancet needle during the lancing process, wherein the material that can be pierced is a thermoplastic elastomer;

and

ii) an analytical test element configured to detect analyte

the analytical test element being permanently connected to the lancet body.

2. Analytical device as claimed in claim 1, characterized in that the lancet body has means for sample liquid transport.

3. Analytical device as claimed in claim 1, characterized in that the test element has means for sample liquid transport.

4. Analytical device as claimed in claim 2, characterized in that the means for sample liquid transport is a capillary gap, a capillary channel or a wick or a bar made of an absorbent material.

5. Analytical device as claimed in claim 2, characterized in that the means for sample liquid transport has a sample application site which is directly adjacent to the position where the lancet needle extends from the lancet body to cut tissue.

6. Process for manufacturing an analytical device as claimed in claim 1, wherein

a lancet is prepared

the lancet needle is sterilized and

subsequently the analytical test element is permanently connected to the lancet body.

7. An analytical device, comprising:

a body,

a lancet needle having at least a tip embedded in the body to maintain the sterility of the tip before use,

the body including material that is pierceable by the lancing tip to form a temporary channel that allows movement of the tip to a extended position where the tip extends from the body to cut tissue,

the tip of the lancet being moveable relative to the body between the extended position and a retracted position where the tip is located inside the material, and

a test element joined to the body for testing of analyte in body fluid from the cut.

8. The device of claim 7, further comprising means for transporting the body fluid to the test element.

9. The analytical device of claim 7, wherein the analytical device has a capillary gap to transport the body fluid to the test element.

10. An apparatus, comprising:

an analytical device comprising

a body,

a lancet needle having at least a tip embedded in the body to maintain the sterility of the tip before use,

the body including material that is pierceable by the lancing tip to form a temporary channel that allows movement of the tip to a extended position where the tip extends from the body to cut tissue,

the tip of the lancet being moveable relative to the body between the extended position and a retracted position where the tip is located inside the material, and

a test element joined to the body for testing of analyte in body fluid from the cut;

a body fluid measuring instrument having a lancet drive mechanism coupled to the analytical device, the drive mechanism being configured to move the tip of the lancet needle between the extended position and the retracted position; and

the analytical device being configured to be removed from the instrument after use and replaced with a new one.

11. The apparatus of claim 10, further comprising a tape that includes plurality of the analytical devices joined together.

12. The apparatus of claim 11, further comprising:

a first belt that includes a plurality of the lancet needles; and

a second belt that includes a plurality of the elements, wherein the second belt is joined to the first belt.

13. An analytical device, comprising:

a body,

a lancet needle having at least a tip embedded in the body to maintain the sterility of the tip before use,

the body including material that is pierceable by the lancing tip to form a temporary channel that allows movement of the tip to a extended position where the tip extends from the body to cut tissue,

the tip of the lancet being moveable relative to the body between the extended position and a retracted position where the tip is located inside the material,

a test element joined to the body for testing of analyte in body fluid from the cut;

wherein the analytical device has a capillary gap to transport the body fluid to the test element; and

wherein the capillary gap is defined at least in part by the body.

14. The device of claim 13, wherein the capillary gap is defined between the body and the test element.

15. The device of claim 13, wherein the capillary gap is defined between the body and the lancet needle.

16. An analytical device, comprising:

a body,

a lancet needle having at least a tip embedded in the body to maintain the sterility of the tip before use,

the body including material that is pierceable by the lancing tip to form a temporary channel that allows movement of the tip to a extended position where the tip extends from the body to cut tissue,

the tip of the lancet being moveable relative to the body between the extended position and a retracted position where the tip is located inside the material,

a test element joined to the body for testing body fluid from the cut;

a plurality of the analytical devices incorporated into a magazine; and

wherein the material minimizes contamination between used and unused ones of the analytical devices in the magazine.

17. The device of claim 16, wherein the magazine is configured for disposal of the plurality of the analytical devices as a whole.

18. An analytical device, comprising:

a body;

a lancet needle having at least a tip embedded in the body to maintain the sterility of the tip before use;

the body including material that is pierceable by the lancing tip to form a temporary channel that allows movement of the tip to a extended position where the tip extends from the body to cut tissue;

the tip of the lancet being moveable relative to the body between the extended position and a retracted position where the tip is located inside the material;

a test element joined to the body for testing of analyte in body fluid from the cut; and

wherein the material includes an elastic material to reseal the channel when the tip returns to the retracted position after the tissue is cut to encapsulate the tip after use.

19. The device of claim 18, wherein the elastic material includes a thermoplastic elastomer.

20. The device of claim 18, wherein the body includes a stiff material joined to the elastic material to stabilize the elastic material during lancing.

21. The device of claim 20, wherein the stiff material includes a stiff plastic.

22. The device of claim 18, wherein the test element includes a stiff material to stabilize the elastic material during lancing.

23. An apparatus, comprising:

a first belt that includes a plurality of lancets, each of the lancets having at least a lancet tip embedded in the first belt to maintain sterility of the lancet tip before use, wherein the first belt is pierceable by the lancet tip of each of the lancets to allow extension of the lancet tip from the first belt to cut an incision in tissue and to allow retraction back inside the first belt after cutting the incision; and

a second belt that includes a plurality of test elements for analyzing body fluid from the incision, wherein the second belt is joined to the first belt.

24. The apparatus of claim 23, wherein the first belt and the second belt are glued together.

25. The apparatus of claim 23, further comprising:

means for cutting the incision, wherein the means for cutting the incision includes the lancets; and

means for analyzing the body fluid, wherein the means for analyzing the body fluid includes the test elements.

26. An analytical device, comprising:

a body;

a lancet having at least lancet tip embedded in the body to maintain sterility of the lancet tip prior to use, the lancet tip being configured to pierce the body when extending from the body during lancing an incision;

wherein the body is configured to hygienically enclose the lancet tip when the lancet tip retracts inside the body after lancing; and

a test element fixed to the body for analyzing analyte in body fluid from the incision.

27. The analytical device of claim 26,

wherein the lancet has an initial position in which at least the lancet tip is embedded in the body to maintain sterility of the lancet tip until immediately before use and an extended position at which the lancet tip extends from the body to create the incision;

wherein the lancet is moveable to return to the initial position after creating the incision to minimize risk of injury; and

wherein the body is pierceable by the lancet tip to allow movement of the lancet to the extended position.

28. The analytical device of claim 26, wherein the body defines a capillary channel that is fixed relative to the body for drawing the body fluid from the incision to the test element.

29. The analytical device of claim 26, wherein:

the body is configured to allow the lancet to be sterilized separately from the test element to prevent contaminants from the test element migrating onto the lancet; and

at least a portion of the body is made of material that is able to be pierced by the lancet tip during lancing to promote automatic body fluid analysis by eliminating manual cap removal from the lancet.

30. The analytical device of claim 26, further comprising:

means for lancing the incision, wherein the means for lancing the incision includes the lancet;

means for maintaining sterility of the lancet tip prior to use, wherein the means for maintaining the sterility includes the body; and

means for analyzing the body fluid, wherein the means for analyzing the body fluid includes the test element.

31. An analytical device, comprising:

a body;

a lancet having at least lancet tip embedded in the body to maintain sterility of the lancet tip prior to use, the lancet tip being configured to pierce the body when extending from the body during lancing an incision;

wherein the body is configured to hygienically enclose the lancet tip when the lancet tip retracts inside the body after lancing;

a test element fixed to the body for analyzing analyte in body fluid from the incision;

wherein the body has at least a portion made of elastic material that is configured to be pierced by the lancet during lancing; and

a stiff material attached to the elastic material to ensure mechanical stability of the elastic material during lancing.

32. The analytical device of claim 31, wherein the body includes the stiff material.

33. The analytical device of claim 31, wherein the test element includes the stiff material.

34. An apparatus, comprising:

a magazine;

a plurality of analytical devices housed in the magazine; and

wherein each of the analytical devices includes

a lancet for creating an incision in tissue,

a body in which at least a portion of the lancet is embedded for maintaining sterility of the lancet prior to creating the incision, wherein the body is able to pieced by the lancet,

a test element coupled to the body for analyzing fluid from the incision, and

wherein the body is configured to encapsulate the lancet after creating the incision to minimize cross-contamination between the used and unused analytical devices in the magazine.

35. The apparatus of claim 34, wherein the magazine is configured to allow disposal of the plurality of the analytical devices at the same time.

36. The apparatus of claim 34, further comprising:

means for creating the incision, wherein the means for creating the incision includes the lancet;

means for maintaining sterility of the lancet prior to creating the incision, wherein the means for maintaining sterility includes the body; and

means for analyzing the fluid from the incision, wherein the means for analyzing the fluid includes the test element.

37. An apparatus, comprising:

an analytical device comprising

a test element configured to analyze analyte in body fluid,

a lancet having a lancet tip configured to pierce tissue to supply the body fluid to the test element,

a body attached to the test element,

at least the lancet tip being sealed inside the body, wherein the body isolates the lancet tip from the test element to allow the lancet to be sterilized separately from the test element, and

the body being pierceable by the lancing tip to permit movement of the lancet tip to an extended position where the lancet tip pierces the tissue.

38. The apparatus of claim 37, further comprising:

a body fluid measuring instrument having a lancet drive mechanism coupled to the analytical device, the drive mechanism being configured to move the lancet tip of the lancet between the extended position and a retracted position; and

the analytical device being configured to be removed from the instrument after use and replaced with a new one.

39. The apparatus of claim 37, further comprising:

a first belt that includes a plurality of the lancets; and

a second belt that includes a plurality of the test elements, wherein the second belt is joined to the first belt.

40. The apparatus of claim 37, further comprising:

a magazine;

a plurality of the analytical device incorporated into the magazine; and

wherein the body of the analytical device minimizes cross-contamination inside the magazine.