WO2025032172A1 - Appareil à biopsie pour assurer le prélèvement d'échantillons de tissus - Google Patents

Appareil à biopsie pour assurer le prélèvement d'échantillons de tissus Download PDF

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Publication number
WO2025032172A1
WO2025032172A1 PCT/EP2024/072448 EP2024072448W WO2025032172A1 WO 2025032172 A1 WO2025032172 A1 WO 2025032172A1 EP 2024072448 W EP2024072448 W EP 2024072448W WO 2025032172 A1 WO2025032172 A1 WO 2025032172A1
Authority
WO
WIPO (PCT)
Prior art keywords
biopsy needle
biopsy
mri
tissue
sample
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/072448
Other languages
German (de)
English (en)
Inventor
Heinz Werner HENKE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ITP INNOVATIVE TOMOGRAPHY PRODUCTS GmbH
Original Assignee
ITP INNOVATIVE TOMOGRAPHY PRODUCTS GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ITP INNOVATIVE TOMOGRAPHY PRODUCTS GmbH filed Critical ITP INNOVATIVE TOMOGRAPHY PRODUCTS GmbH
Priority to EP24762579.1A priority Critical patent/EP4554468A1/fr
Publication of WO2025032172A1 publication Critical patent/WO2025032172A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275—Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/055—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3954—Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI

Definitions

  • the invention relates to a biopsy device for taking tissue samples under MRI visualization, with a biopsy needle attached to a handling device, which can be inserted into the tissue to be examined and which is provided in its distal end region with a laterally open sample receiving space extending in its longitudinal direction, over which a cutting sleeve closely surrounding the biopsy needle and provided distally with a cutting edge can be moved in order to cut off the tissue sample that has penetrated into the sample receiving space of the biopsy needle after the biopsy needle has been inserted from the surrounding tissue, wherein the biopsy device as a whole consists of materials that are suitable for MRI visualization.
  • Such a biopsy device is known, for example, from DE 100 42 519 C1, where all of its functions are described. It is important that the biopsy needle and the cutting sleeve surrounding it on the one hand and the handling device with the drive devices for the cutting sleeve contained therein on the other hand are made of non-magnetic materials so that the MRI imaging is not disturbed by unwanted artifacts.
  • the invention proposes, based on the biopsy device of the type mentioned at the beginning, that MRI visualization markers are arranged in the sample receiving chamber of the biopsy needle, on the one hand in the area of its distal end and on the other hand in the area of its proximal end, which are designed as layers applied to the axial end surfaces of the sample receiving chamber. Because these MRI visualization markers are located exactly at the beginning and end of the sample receiving chamber, when handling the device under MRI visualization one can see very precisely where the tissue sample is taken in the tissue.
  • the MRI visualization markers are applied to surfaces where a thicker coating does not interfere, it is possible to use an inexpensive polymer as an MRI contrast agent, for example, and if necessary, to add suitable MRI markers, such as nano-iron particles or similar, which can be applied sufficiently thickly to the end surfaces of the sample receiving space without significantly reducing its size.
  • a preferred embodiment of the biopsy device according to the invention provides that the polymer layers used as MRI visualization markers are 0.1 mm to 2 mm, preferably 0.2 to 1 mm thick. This easily gives the MRI visualization markers a volume that is sufficient for visualization with an MRI device.
  • biocompatible cyanoacrylates which can be self-cured or cured by UV light, have proven to be cost-effective polymers for the production of MRI visualization markers.
  • Figure 1 schematically shows a biopsy device according to the invention in perspective view
  • Figure 1 a enlarged view of detail A of Figure 1 , i.e. the distal end portion of the biopsy needle;
  • Figures 2 and 2a a plan view of Figures 1 and 1a;
  • Figures 3 and 3a a side view of Figures 1 and 1a
  • the handling device of the biopsy device according to the invention is designated with the reference number 1.
  • a biopsy needle 2 is attached to this handling device 1, which is provided at its distal end with a beveled cutting edge 3, which cuts into the tissue to be examined when the biopsy needle is inserted.
  • the biopsy needle 2 is provided in its distal end region with a sample receiving space 4 that extends in its longitudinal direction and is open at the side.
  • a cutting sleeve 6 that closely surrounds the biopsy needle 2 and is provided distally with a cutting edge 5 can be pushed over this sample receiving space 4.
  • This cutting sleeve 6 is connected to a spring drive (not shown in detail in the drawing) arranged in the handling device 1, which When triggered, the cutting sleeve 6 moves at very high speed over the biopsy needle 2 to its distal end region.
  • All previously mentioned components of the biopsy device according to the invention are made of non-magnetic materials, i.e. materials that cannot interfere with MRI visualization during the biopsy.
  • MRI visualization markers are arranged in the sample receiving chamber 4 of the biopsy needle 2 on the one hand in the region of its distal end and on the other hand in the region of its proximal end, which MRI visualization markers are designed as polymer layers applied to the axial end surfaces of the sample receiving chamber 4.
  • These polymer layers that serve as MRI visualization markers are between 0.1 mm and 2 mm thick, but preferably 0.2 to 1 mm thick, and consist, for example, of a polymer mixed with MRI markers, which can thus be perceived relatively accurately and correctly positioned as an artifact during MRI visualization.
  • certain other materials are also suitable for MRI visualization.
  • the concentration of the particles in the polymer can be used to influence the intensity of the resulting artifacts so that the visibility of the biopsy notch is optimal.
  • the biopsy needle 2 is first inserted into the tissue to be examined using the handling device 1 until the sample receiving chamber 4 has reached the area of the tissue to be examined from which the tissue sample is to be taken.
  • the tissue to be examined penetrates from the side into the laterally open sample receiving chamber 4. Because the beginning and end of the sample receiving chamber 4 are clearly visible with MRI visualization due to the MRI visualization markers assigned to it, it is possible for the first time to precisely localize the area within the tissue from which the tissue sample is to be taken.
  • the cutting sleeve 5 surrounding the biopsy needle 2 is displaced at high speed towards the distal end of the biopsy needle by triggering the spring drive located in the handling device 1, so that the cutting edge 6 of the cutting sleeve 5 cuts off the tissue that has penetrated into the sample receiving space 4 as a tissue sample from the surrounding tissue and at the same time the cutting sleeve 5 closes off the sample receiving space 4.
  • the tissue sample enclosed in the sample receiving space 4 can then be removed without coming into contact with the surrounding tissue again along the puncture channel.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Physics & Mathematics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biophysics (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)

Abstract

L'invention concerne un appareil à biopsie destiné à assurer le prélèvement d'échantillons de tissus sous visualisation par IRM, ledit appareil à biopsie comprenant une aiguille à biopsie (2) qui est fixée à un dispositif de manipulation (1) et qui peut être introduite dans le tissu à examiner, l'aiguille à biopsie étant munie, dans sa zone d'extrémité distale, d'un espace de réception d'échantillon (4) ouvert latéralement, qui s'étend dans la direction longitudinale de ladite aiguille, et par l'intermédiaire duquel un manchon de coupe (5), qui entoure étroitement l'aiguille à biopsie (2) et qui comporte une arête de coupe (6), peut être déplacé de manière à séparer du tissu qui l'entoure l'échantillon de tissu qui est entré dans l'espace de réception d'échantillon (4) de l'aiguille à biopsie (2) après insertion de l'aiguille à biopsie, l'appareil étant constitué dans son ensemble de matériaux qui sont appropriés à la visualisation par IRM. L'invention vise à perfectionner un appareil à biopsie de ce type afin de permettre de reconnaître de manière plus précise par imagerie par IRM l'endroit où l'échantillon de tissu est prélevé. A cet effet, selon l'invention, des marqueurs de visualisation par IRM, qui sont conçus sous la forme de couches polymères appliquées sur les surfaces d'extrémité axiales (4 a, 4 b) de l'espace de réception d'échantillon (4), sont disposés dans l'espace de réception d'échantillon (4) de l'aiguille à biopsie (2), d'une part dans la zone de l'extrémité distale dudit espace de réception d'échantillon et d'autre part dans la zone de l'extrémité proximale dudit espace de réception d'échantillon.
PCT/EP2024/072448 2023-08-09 2024-08-08 Appareil à biopsie pour assurer le prélèvement d'échantillons de tissus Pending WO2025032172A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP24762579.1A EP4554468A1 (fr) 2023-08-09 2024-08-08 Appareil à biopsie pour assurer le prélèvement d'échantillons de tissus

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE202023104521.9 2023-08-09
DE202023104521.9U DE202023104521U1 (de) 2023-08-09 2023-08-09 Biopsiegerät zur Entnahme von Gewebeproben

Publications (1)

Publication Number Publication Date
WO2025032172A1 true WO2025032172A1 (fr) 2025-02-13

Family

ID=88975297

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2024/072448 Pending WO2025032172A1 (fr) 2023-08-09 2024-08-08 Appareil à biopsie pour assurer le prélèvement d'échantillons de tissus

Country Status (3)

Country Link
EP (1) EP4554468A1 (fr)
DE (1) DE202023104521U1 (fr)
WO (1) WO2025032172A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5782764A (en) * 1995-11-07 1998-07-21 Iti Medical Technologies, Inc. Fiber composite invasive medical instruments and methods for use in interventional imaging procedures
DE10042519C1 (de) 2000-08-30 2002-04-04 Karlsruhe Forschzent Biopsiegerät für den MRT-Einsatz
DE102011101680A1 (de) * 2011-03-25 2012-09-27 Itp Innovative Tomography Products Gmbh Marker zur MRT-Visualisierung von Medizinprodukten
DE102011101860A1 (de) 2011-05-12 2012-11-15 Thyssenkrupp Aufzugswerke Gmbh Verfahren und Vorrichtung zum Steuern einer Aufzugsanlage
US20170059672A1 (en) * 2004-05-21 2017-03-02 Devicor Medical Products, Inc. Mri biopsy apparatus incorporating an imageable penetrating portion

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5782764A (en) * 1995-11-07 1998-07-21 Iti Medical Technologies, Inc. Fiber composite invasive medical instruments and methods for use in interventional imaging procedures
DE10042519C1 (de) 2000-08-30 2002-04-04 Karlsruhe Forschzent Biopsiegerät für den MRT-Einsatz
US20170059672A1 (en) * 2004-05-21 2017-03-02 Devicor Medical Products, Inc. Mri biopsy apparatus incorporating an imageable penetrating portion
DE102011101680A1 (de) * 2011-03-25 2012-09-27 Itp Innovative Tomography Products Gmbh Marker zur MRT-Visualisierung von Medizinprodukten
DE102011101860A1 (de) 2011-05-12 2012-11-15 Thyssenkrupp Aufzugswerke Gmbh Verfahren und Vorrichtung zum Steuern einer Aufzugsanlage

Also Published As

Publication number Publication date
EP4554468A1 (fr) 2025-05-21
DE202023104521U1 (de) 2023-11-09

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