Biopsy instrument comprising a magnetic element

• US 9,247,928 B2
• Filed: 10/20/2010
• Issued: 02/02/2016
• Est. Priority Date: 10/20/2009
• Status: Expired due to Fees

• Current Assignee: Ogeno GmbH
• Original Assignee: Ogeno GmbH
• Inventors: Pison, Ulrich, Pietschmann, Silvia, Meissner, Wolfgang
• Primary Examiner(s): Dougherty, Sean
• Assistant Examiner(s): CERIONI, DANIEL LEE
• Application Number:
  US13/503,002
• Publication Number:
  US 20120302916A1
• Time in Patent Office: 1,931 Days
• Field of Search: 600/562, 600/573
• US Class Current: 1/1
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: G01N 33/54326 Magnetic particles
• CPC Class Codes: G01N 33/54346 Nanoparticles
• CPC Class Codes: G01N 33/569 for microorganisms, e.g. protozoa, bacteria, viruses

Abstract

The invention relates to a magnetic biopsy-instrument and use thereof for enriching specific sample material from the body. The invention also relates to a biopsy-kit and use thereof for enriching specific sample material.

Claims

1. A biopsy instrument for the enrichment of sample material, comprising:

i. a non-magnetic guide element comprising a spring-elastic distal most portion of the guide element and a proximal portion,

ii. a magnetic element having a first end and a second end that is fitted between the distal portion and the proximal portion of the guide element, and

iii. a non-magnetic stabilizing element connected to the proximal portion of the guide element,

wherein the first end of the magnetic element directly abuts the spring-elastic distal portion of the guide element and the second end of the magnetic element directly abuts the stabilizing element, wherein the biopsy instrument is configured for the enrichment of the sample material and for insertion into a body of a subject, and

wherein the stabilizing element is configured to stabilize the magnetic element during a biopsy and to avoid dislocation of the magnetic element and the stabilizing element being

a. adhesively bonded and/or welded to the proximal portion of the guide element, or

b. adapted to be slid over the proximal portion of the guide element.

2. The biopsy instrument according to claim 1,

wherein the distal portion of the guide element, the magnetic element and the stabilizing element are arranged sequentially from distal to proximal.

3. The biopsy instrument according to claim 1,

wherein the stabilizing element is cylindrical.

4. The biopsy instrument according to claim 1,

wherein the outer diameter of the stabilizing element is equal to the outer diameter of the distal portion of the guide element.

5. The biopsy instrument according to claim 1,

wherein the stabilizing element is reversibly connected to the proximal portion of the guide element.

6. The biopsy instrument according to claim 1,

wherein the stabilizing element is made of plastic.

7. The biopsy instrument according to claim 1,

wherein the guide element and the stabilizing element are fabricated using one manufacturing process.

8. The biopsy instrument according to claim 1,

wherein the magnetic element has a cylindrical shape.

9. The biopsy instrument according to claim 1,

wherein the magnetic element has an outer diameter that is smaller than the outer diameter of the distal portion of the guide element.

10. The biopsy instrument according to claim 1,

wherein the magnetic element is additionally equipped with detection molecules.

11. The biopsy instrument according to claim 1,

wherein between the distal and the proximal portions, the guide element has a receptacle device that serves for receiving the magnetic element.

12. The biopsy instrument according to claim 1,

wherein the magnetic element contains magnetic materials and may comprise metal, plastic and/or ceramic materials, or is an electromagnet.

13. The biopsy instrument according to claim 1,

wherein the detection molecules are selected from the group comprising antibodies, antibody fragments, protein scaffolds, peptides, nucleic acids, receptors and/or are inorganic materials.

14. The biopsy instrument according to claim 1,

wherein the spring-elastic distal portion of the guide element comprises detection molecules.

15. The biopsy instrument according to claim 1,

wherein the biopsy instrument further comprises a covering device.

16. The biopsy instrument according to claim 15,

wherein the covering device covers the magnetic element, and wherein the covering device comprises homopolymers, copolymers, biopolymers, chemically modified polymers and/or synthetic polymers.

17. The biopsy instrument according to claim 1,

wherein the biopsy instrument has a longitudinal bore configured to receive a mandrin.

18. The biopsy instrument of claim 1 for endoscopic applications further comprising an adaptor and/or a longitudinally movable sheath.

19. The biopsy instrument according to claim 9,

wherein the magnetic element has an outer diameter that is 0.0001 mm to 5 mm smaller than the outer diameter of the distal portion of the guide element.

20. The biopsy instrument according to claim 9,

wherein the magnetic element has an outer diameter that is 0.01 mm to 0.1 mm smaller than the outer diameter of the distal portion of the guide element.

21. The biopsy instrument according to claim 1, wherein the stabilizing element is adhesively bonded and/or welded to the proximal portion of the guide element.

22. A method for binding microorganisms, tumor cells, trophoblasts, biomarkers or other cell populations or molecules, the method comprising

providing the biopsy instrument according to claim 1, wherein the method comprises:

i. coupling one or more ligands to magnetic nanoparticles;

ii. binding said ligands to microorganisms, tumor cells, trophoblasts, biomarkers or other cell populations or molecules;

iii. binding the magnetic nanoparticles to at least one magnetic element of the biopsy instrument.

23. The method according to claim 22,

wherein the one or more ligand is oligoacyllisin and/or a glycopeptide antibiotic.

24. The method of claim 22 further comprising enriching samples from the vascular system, efferent glandular ducts of the pancreas, lachrymal gland, parodit gland, efferent ducts of the mucosal glands, mixed glands, cutaneous and sebaceous glands, mammary gland, spinal canal, brain chamber system, peridural space, gall bladder and its efferent anatomical structures, efferent urinary tracts or the lymphatic system, body cavities of the abdomen or the chest, the uterus, the urogenital apparatus, or a joint or the gastrointestinal tract.

25. The method of claim 22, wherein said method is a diagnostic method which includes prenatal diagnosis, cancer diagnosis and therapy follow-up as well as diagnosis of a disease selected from the group consisting of inherited diseases, proliferative diseases, inflammatory diseases, autoimmune diseases, infectious diseases, hormonal disorders, diseases of blood and blood-forming organs, diseases of the digestive tract, liver, bile, pancreas, diseases of the urogenital tract and the kidney, diseases of the heart, abnormal changes in the vascular system and lymphatic system, pulmonary diseases, diseases of the central or peripheral nervous system and of the electrical stimulus transmission, and neurodegenerative diseases.

26. The method of claim 25,

wherein the diagnosis of infectious disease refers to a diagnosis of a disease caused by parasitic, bacterial or viral infection, the prenatal diagnosis refers to a diagnosis of gene mutations, chromosome mutations and chromosome aberrations from the group of a deletion, inversion, duplication, translocation and of ring chromosomes, or of a malfunction of gene transcription, gene translation, mRNA stability, of a splice variant, of a malfunction of the mRNA transport into the cytoplasm, of the protein biosynthesis and/or an epigenetic factor;

the cancer diagnosis is used as a primary diagnosis, diagnosis for tumor spread, or for tumor grading;

the therapy follow-up refers to monitoring a tumor treatment, monitoring an autologous, syngeneic, allogeneic, xenogeneic or alloplastic transplantation, monitoring an inflammatory disease, monitoring an infectious disease, monitoring a hormonal disease, monitoring a psychiatric disorder or monitoring a neurodegenerative disease;

the hereditary disease is selected from the group consisting of an autosomal recessive, autosomal dominant, gonosomal and mitochondrial and/or extra-chromosomal hereditary disease, or a disease that can be attributed to a genetic disposition;

the proliferative disease is selected from the group consisting of a tumor, precancerosis, dysplasia, neuroendocrine tumor, endometriosis and metaplasia;

the autoimmune disease is selected from the group consisting of rheumatoid arthritis, inflammatory bowel disease, osteoarthritis, neuropathic pain, alopecia areata, psoriasis, psoriatric arthritis, acute pancreatitis, allograft rejection, allergies, allergic inflammation of the lung, multiple sclerosis, Alzheimer'"'"'s disease, Crohn'"'"'s disease and systemic lupus erythematous;

the infectious disease is selected from the group consisting of parasitic diseases, bacterial diseases or viral diseases;

or the hormonal disease is selected from the group consisting of diseases of sugar metabolism, lipid metabolism, protein metabolism, sexual development and reproduction, water-salt balance, growth and cell formation.

27. The method of claim 24, wherein the method comprises a minimal invasive surgical procedure.

28. A biopsy instrument for the enrichment of sample material, comprising:

i. a non-magnetic guide element comprising a spring-elastic most distal portion of the guide element and a proximal portion,

ii. a magnetic element that is fitted between the distal portion and the proximal portion of the guide element, and

iii. a non-magnetic stabilizing element connected to the proximal portion of the guide element, wherein the magnetic element is configured to be releasably attached to the guide element and/or wherein the stabilizing element is configured to be reversibly connected to the proximal portion of the guide element, wherein the biopsy instrument is configured for the enrichment of the sample material and for insertion into a body of a subject, and

wherein the stabilizing element is configured to stabilize the magnetic element during a biopsy and to avoid dislocation of the magnetic element.