Method and device for withdrawing biological samples

• US 6,659,338 B1
• Filed: 03/07/2000
• Issued: 12/09/2003
• Est. Priority Date: 09/11/1997
• Status: Expired due to Term

• Current Assignee: Caisley International GmbH
• Original Assignee: Biopsytec GmbH
• Inventors: Gut, Ivo Glynne, Heuermann, Arno Svend, Dittmann, Thomas Claus, Olek, Alexander
• Primary Examiner(s): Lee, Michael G.
• Assistant Examiner(s): Kim, Ahshik
• Application Number:
  US09/508,144
• Time in Patent Office: 1,372 Days
• Field of Search: 235/375, 235/385, 235/462, 422/65, 422/102, 600/566, 600/573
• US Class Current: 235/375
• CPC Class Codes: A01K 11/003 with means for taking tissue samples, e.g. for DNA analysis
• CPC Class Codes: A01K 11/004 with electronic identification means, e.g. transponders
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: G01N 1/04 in the solid state, e.g. by cutting

Abstract

The invention relates to a method and device for withdrawing biological samples. The device has a receptacle which can receive one or several covers for sample containers, another receptacle which can receive one or several sample containers, and a mechanism. Said mechanism joins the covers and containers together during a working cycle in which the biological sample is withdrawn either through the cover or the sample container to a test capsule.

Claims

1. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that the device makes available a mechanism, which punches or shoots a component of a test capsule by means of a type of firing pin through the tissue, after placement of the device on tissue and actuating the trigger mechanism, in such a way that a tissue sample is removed on the path through the tissue and the sample remover is brought together with another part of a test capsule in the same course of motion to produce the closed test capsule.

2. A device according to claim 1, further characterized in that

the part of the device bearing the sample container and the part of the device bearing the test capsule cover can be pressed together in such a way from opposite sides solidly onto the tissue, such that a mechanism found on one of the two sides can use a part of the test capsule for a sample removal, and

the pressure thus exercised and the distance between the part of the device bearing the sample container and the part of the device bearing the test capsule cover can be regulated by an adjusting screw or analogous device.

3. A device according to claim 1, further characterized in that the device makes available a mechanism, which moves these components of a test capsule, by actuating a trigger mechanism jointly within the magazine, by one position in the direction of a sample-removing mechanism of the device.

4. A device according to claim 1, further characterized in that the device makes available a possibility for data entry and/or for data output or is coupled to such a device.

5. A device according to claim 1, further characterized in that the device makes available a mechanism and/or electronic unit, by means of which, data such as

the serial number of the sample container or several sample containers linked together and/or

information on the organism, whose sample is removed, and/or

other information, which concerns the sample removal, are read in automatically.

6. A device according to claim 1, further characterized by the fact that the device comprises a receptor to hold one or more covers for sample containers.

7. A device according to claim 1, further characterized by the fact that the device comprises a receptor to hold one or more sample containers.

8. A device according to claim 1, further characterized in that the trigger mechanism is blocked by another mechanism, which is released only by the prior input or confirmation of data.

9. A device according to claim 1, further characterized by the fact that the device makes available a mechanism, which joins the test capsule cover and the sample container in one working cycle with the removal of a biological sample either by the test capsule cover or by the sample container to form the test capsule.

10. A device according to claim 1, further characterized in that one of the components of the sample capsule is suitable for the purpose of being used directly as the sample remover for removing a biological sample.

11. A device according to claim 1, further characterized in that one component of the test capsule is used for removing a tissue sample by punching, shooting, scraping, pinching, guided shooting, by tearing out hairs, or conducting the movement of a biopsy needle.

12. A device according to claim 1, further characterized in that one of the parts of the test capsule, which remains in the tissue of the animal whose sample was removed, includes

a barcode,

the readable and/or writeable integrated circuit,

a magnetic strip,

a transponder,

a transmitter,

a numerical code,

a letter code, or

a comparable coding or information carrier system

or a simple color or analogous labeling.

13. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that the device contains one or more magazines, in which test capsule covers, sample containers and parts of labelings can be loaded each time individually or in strips.

14. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that the device makes available a mechanism, which

in a first step, presses together the sample-removing part of the test capsule upon placing the device on the tissue and after actuating the trigger mechanism, in such a way that a tissue sample is removed by a pinching motion;

or, in a first step, upon placement of the device on the tissue and after actuating the trigger mechanism, advances the sample-removing part of the test capsule on the tissue such that a tissue sample is removed by a scraping motion;

or, in a first step, upon applying the device on the tissue and after actuating the trigger mechanism, advances the sample-removing part of the test capsule while squeezing together the sample remover at the tissue in such a way that hairs are torn out;

and in another step of the same course of movement or an additional actuating of the trigger mechanism joins the sample remover with another part of the test capsule to form the test capsule.

15. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that

the device makes available a possibility of associating the entered or automatically read-in serial numbers of the test capsules and the entered or automatically read-in information on the animal, whose sample has been taken, and other information concerning the respective sample removal;

and

storing these data on a storage medium along with the information on the association of these data.

16. A device according to claim 15, further characterized in that the storage medium is a) installed rigidly in the device or b) can be separated from it.

17. A device according to claim 15, further characterized in that said device includes an electronic unit, by means of which all stored data and information on the association of these data can be transmitted in a wireless manner and data can also be received, if need be, in a wireless manner.

18. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device characterized by the fact that the device is loaded with a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby simultaneously the biological sample is taken and the sample container and the cover are joined to form the test capsule and together with taking the sample a labelling of the living being, from which the sample is taken, takes place by joining components of the sample container and the cover into the tissue of the living being, whereby the labelling of the living being, the labelling of the sample capsule are entered or read in and whereby these information are stored in order to achieve the correlation of the sample capsule and the living being.

19. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that the device makes available a mechanism, which introduces a labeling on the animal, coupled with a removal of sample, which consists either of a) a simple color label or b) a self-adhering foil, c) an adhering badge or d) a self-adhering device or one that is rigidly anchored in the tissue, which carries one of

a barcode,

a readable and/or writeable integrated circuit,

a magnetic strip,

a transponder,

a transmitter,

a numerical code,

a letter code, or

a comparable coding or information carrier system

or a simple color labeling.

20. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that

one or more identical components of such test capsules are linked with one another;

the strips or rings that are formed of parts of test capsules can be loaded into the magazine or into an analogous device as units of more than only one such part of a test capsule;

the direction in which these strips or rings of several such units are loaded into the device is established by a labeling introduced on only one site of such a strip or ring;

the serial numbers of all such linked parts of test capsules are defined by only this one serial number in a clear manner.

21. A device according to claim 20, further characterized in that the serial number, which is introduced onto these strips or rings has a form that is automatically readable by a device provided for this purpose or must be read by the user himself and manually entered into a device provided for this purpose.

22. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that the sample capsule has a site, which permits piercing with needles, pins, cannula or comparable devices.

23. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that said device comprises one or more parts, which can be separated, in order to remain as a labeling in the tissue of the living being, whose sample was removed.

24. A sample container for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said sample container further characterized in that after said sample container has been sealed by the test capsule cover, said sample container can be opened again or its contents can be reached only by leaving behind changes that can be discerned.

25. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that the capsule also includes means for making an ear mark on an animal whose sample was removed after the test capsule has been joined.

26. A device according to claim 25, further characterized in that the ear mark remaining in the tissue can be removed only by leaving behind visible damage to either the ear mark or the animal.

27. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that the sample-removing part of the test capsule on the side turned away from the sample has depressions, which serve for the purpose of pressing and squeezing the sample remover a) at the tissue in such a way that a tissue sample is removed by pinching or b) advancing it obliquely and under pressure at the tissue in such a way that a tissue sample is removed by scraping.

28. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that the sample container cover is slotted and partly conical, so that two or more tips will be easily punched into it upon contacting the test subject, and then are pressed together due to the conical shape, so that a small quantity of sample is sheared off or cut and no additional material will be removed.

29. A method for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said method further characterized in that the user of the device conducting the method must enter or confirm data before each or before a series of sample removals, in order to release the device.

30. A method for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said method further characterized in that all operating steps necessary for sample removal and labelling are coupled together in such a way that none of the operating steps can be conducted individually.

31. A method for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said method further characterized in that a labeling of the living being from which a sample is removed is conducted during or coupled with the actual sample removal.

32. A method for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said method further characterized in that the labeling cannot be removed after said labeling has been introduced on the living being or said labeling can be removed only by disrupting or damaging said labeling or damaging the living being.

33. A method for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said method further characterized in that the labeling includes:

a barcode,

a readable and/or writeable integrated circuit,

a magnetic strip,

a transponder,

a transmitter,

a numerical code,

a letter code or

a comparable coding or information carrier system

or a simple color labeling.

34. A method according to claim 33, further characterized in that a test capsule is sealed in a way, which makes it impossible to open the test capsule again without obvious changes to this test capsule.

35. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that a test capsule is sealed in a way, which makes it impossible to open the test capsule again without obvious changes to said test capsule.

36. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that after it has been sealed by the test capsule cover, it can be opened again or its contents can be reached only by leaving behind changes that can be discerned.

37. A test capsule for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said test capsule further characterized in that individual sample containers or several sample containers joined together in a chain make available one serial number, which is introduced during manufacture or later.

38. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that parts of the test capsule are filled with reagents necessary for the further processing of the sample.

39. A device for withdrawing biological samples, characterized by the fact that by means of a sample-removing device a tissue sample is removed from a living being, wherein by taking the sample a coded labeling of the living being and part of the sample-removing device takes place, said device consisting of a sample container, formed out of one or two components, and a cover for sample containers, formed out of one or two components, whereby the sample container and the cover are joined to form the test capsule, said device further characterized in that the device

can read the labeling of the sample containers either automatically or this information can be received and processed by the user,

data on the identity of the sample to be removed are automatically or manually recorded,

the data on the consecutive numbering of the sample vessels are automatically associated with the data on the sample by the removal device,

data on the sample vessel number and sample are stored on a common storage medium,

the stored data are transmitted to the analytical device by means of direct data transmission from the removal device or from an additional device or by transport of a data carrier that can be separated.