WO2002062232A1 - Appareil de biopsie et procede y relatif - Google Patents

Appareil de biopsie et procede y relatif Download PDF

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Publication number
WO2002062232A1
WO2002062232A1 PCT/US2002/004998 US0204998W WO02062232A1 WO 2002062232 A1 WO2002062232 A1 WO 2002062232A1 US 0204998 W US0204998 W US 0204998W WO 02062232 A1 WO02062232 A1 WO 02062232A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
tube
basket
knife
biopsy apparatus
Prior art date
Application number
PCT/US2002/004998
Other languages
English (en)
Inventor
Frank Viola
Original Assignee
Tyco Healthcare Group Lp
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 Tyco Healthcare Group Lp filed Critical Tyco Healthcare Group Lp
Publication of WO2002062232A1 publication Critical patent/WO2002062232A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0283Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe

Definitions

  • the present disclosure relates to instruments and methods used for obtaining tissue samples. More particularly, the present disclosure relates to minimally invasive biopsy instruments and methods for obtaining tissue samples.
  • Biopsy may be done by an open or percutaneous technique. Open biopsy removes the entire mass (excisional biopsy) or a part of the mass (incisional biopsy). Percutaneous biopsy on the other hand is usually done with a needle-like instrument and may be either a fine needle aspiration (FNA) or a core biopsy. In core biopsy, as the term suggests, a core or fragment tissue is obtained for histologic examination which may be done via frozen section or paraffin section.
  • FNA fine needle aspiration
  • Intact tissue from the organ or lesion is preferred by medical personnel in order to arrive at a definitive diagnosis regarding the patient's condition. In most cases only part of the organ or lesion need be sampled. The portions of tissue extracted must be indicative of the organ or lesion as a whole. In the past, to obtain adequate tissue from organs or lesions within the body, surgery was performed so as to reliably locate, identify and remove the tissue. With present technology, medical imaging equipment such as stereotactic x-ray, fluoroscopy, computer tomography, ultrasound, nuclear medicine and magnetic resonance imaging, may be used. These technologies make it possible to identify small abnormalities even deep within the body. However, definitive tissue characterization still requires obtaining adequate tissue samples to characterize the histology of the organ or lesion.
  • Biopsy guns were introduced for use in conjunction with these guidance systems. Accurate placement of the biopsy guns was important to obtain useful biopsy information because only one small core could be obtained per insertion at any one location. To sample the lesion thoroughly, many separate insertions of the instrument had to be made.
  • Biopsy procedures may benefit from larger tissue samples being taken, for example, tissue samples as large as 10 mm across.
  • Many of the prior art devices required multiple punctures into the breast or organ in order to obtain the necessary samples. This practice is both tedious and time consuming.
  • tissue sample is to utilize a device capable of taking multiple tissue samples with a single insertion of an instrument.
  • biopsy instruments extract a sample of tissue from a tissue mass by either drawing a tissue sample into a hollow needle via an external vacuum source or by severing and containing a tissue sample within a notch formed on a stylet.
  • Such devices generally contemplate advancing a hollow needle into a tissue mass and applying a vacuum force to draw a sample into the needle and hold the same therein while the tissue is extracted.
  • a biopsy apparatus employs an outer hollow knife tube cannula with a distal end cutter, a trocar rod and a tissue basket tube.
  • the trocar and tissue basket tube are configured to be removably positioned within the knife tube.
  • the trocar rod has a piercing tip on its distal end.
  • the tissue basket tube contains a tissue basket for obtaining and transporting tissue samples that is in fluid communication with a vacuum source.
  • a biopsy method is provided wherein a biopsy apparatus employs an outer hollow knife tube with a distal end cutter and an inner trocar rod member to penetrate a patient's tissue and position the apparatus at least partially within the tissue to be sampled.
  • the trocar rod is removed from the hollow knife tube and the tissue basket tube is positioned in the distal end of the hollow knife tube and at least partially within the tissue to be sampled.
  • the hollow tube is withdrawn to at least partially expose the tissue basket to the tissue to be sampled.
  • a vacuum is applied to assist the natural prolapse of tissue into the tissue port and the distal end cutter of hollow knife tube is repositioned over the issue basket to sever a tissue sample.
  • the tissue basket tube transports the tissue sample through the hollow knife tube.
  • FIG. 1 is a perspective view of one embodiment of the knife tube, trocar rod, and tissue basket tube biopsy apparatus in accordance with the present disclosure
  • FIG. 2 is a longitudinal cross sectional view of one embodiment of the knife tube, and trocar rod as constructed in accordance with the present disclosure in a first position;
  • FIG. 3 is a longitudinal cross sectional view of one embodiment of the knife tube and tissue basket constructed in accordance with the present disclosure in a second position;
  • FIG. 4 is a longitudinal cross sectional view of one embodiment of the knife tube and tissue basket constructed in accordance with the present disclosure in a third position; and
  • FIG. 5 is a longitudinal cross sectional view of one embodiment of the knife tube, and tissue basket constructed in accordance with the present disclosure in a fourth position.
  • biopsy apparatus 100 includes a knife tube 10, a trocar rod 20, and a tissue basket tube 30.
  • tissue basket tube 30 For purposes of clarity, only the details of the working distal ends 12, 22, and 32 are illustrated in detail.
  • the proximal ends 14, 24, and 34 may be attached to a suitable handle or actuator to facilitate operation of biopsy apparatus 100 or any of the other biopsy apparatus embodiments or configuration disclosed herein.
  • biopsy apparatus 100 may include a housing wherein knife tube 10, trocar rod 20, and tissue basket tube 30 are housed.
  • the housing may include suitable known driving and actuating mechanisms.
  • a penetrating member such as the knife tube and trocar rod may be rapidly movable into position at the target tissue location by a suitable drive mechanism, such as, for example, potential energy devices, drive motors, pneumatic devices, or any other suitable drive mechanism.
  • Knife tube 10 includes a distal end 12 and a proximal end 14 wherein tubular wall
  • Knife tube 10 is preferably fabricated from a stainless steel, but it could be made of medical grade plastic or composite molded to contain an integral metal cutting edge 15.
  • Cutting edge 15 is preferably fabricated from stainless steel by a suitable process, such as stamping or metal injection molding.
  • Trocar rod 20 includes a distal end 22 with a piercing tip or knife blade tip 25 and a proximal end 24.
  • Trocar 20 is sealingly engaged and removably positioned within knife tube 10 and can be repositioned about the longitudinal axis "X.”
  • Trocar 20 is a solid rod injection molded of a polycarbonate, or similarly suitable type material in which knife blade tip 25 on distal end 22. Knife blade tip 25 is preferably fabricated of stainless steel.
  • Tissue basket tube 30 includes a distal end 32 and a proximal end 34.
  • Tissue basket tube 30 has a tubular wall 36 that defines at least one tissue port 35 near distal end 32.
  • Tissue basket tube 30 is sealingly engaged and removably positioned within knife tube 10 and concentric with longitudinal axis "X.”
  • Tissue port 35 also partially defines a tissue basket 37 in combination with inside walls 38 and a floor 40.
  • Floor 40 further defines a plurality of holes 39 that are in fluid communication with a vacuum passageway 41 and a vacuum source (not shown).
  • Tissue basket tube 30 is preferably fabricated from a suitable medical grade metal, but it could alternatively be fabricated from a suitable polycarbonate type material.
  • biopsy apparatus 100 or any of the other biopsy apparatus embodiments or configuration disclosed herein may be inserted by suitable known techniques, for example, by motor driver or spring fired mechanisms. Alternatively, biopsy apparatus 100 may be inserted manually. In either arrangement, biopsy apparatus 100 or • any of the other biopsy apparatus embodiments or configuration disclosed herein may be configured as a hand held apparatus or as part of a frame mounted device. An example of such a device is an image guided positioning apparatus such as a stereotactic imaging machine. Any suitable imaging modality may be used to guide biopsy apparatus to the target tissue.
  • Biopsy apparatus 100 in a first position is in a first position as shown with trocar rod 20 concentrically positioned and sealingly engaged within knife tube 10.
  • Biopsy apparatus 100 utilizing cutting edge 15 and knife blade tip 25 pierces a patient in the first position and is at least partially positioned within a tissue portion 50.
  • biopsy apparatus 100 is in a second position wherein knife tube 10 is maintained in position at least partially within tissue portion 50 while trocar rod 20 is removed and replaced by tissue basket tube 30.
  • Tissue basket tube 30 is sealingly engaged with knife tube 10 and the at least one tissue basket 37 is positioned in the portion of distal end of knife tube 10 that is positioned at least partially within the tissue to be sampled.
  • biopsy apparatus 100 is in a third position wherein knife tube 10 is withdrawn proximally to at least partially expose tissue port 35 and tissue basket 37.
  • the prolapse of tissue portion 50 into tissue port 35 is augmented by the application of the vacuum communicated from the vacuum source through passageway 41 to holes 45 defined in the floor 40 of tissue basket 37.
  • biopsy apparatus 100 is in a fourth position wherein tissue basket tube 30 is withdrawing proximally and the distal end cutting edge 15 of knife tube 10 has severed a tissue sample 55 from tissue portion 50. Severed tissue sample 55 is retained in tissue basket 37 and withdrawn proximally through knife tube 10.
  • knife tube 10 is repositioned at least partially within the tissue to be sampled and tissue basket tube 30 is repositioned in knife tube 10 so as to be positioned at least partially within the tissue to be sampled using the same or a different combination of longitudinal position or radial orientation.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un appareil de biopsie destiné au prélèvement d'échantillons de tissus internes, comprenant un tube à bistouri extérieur, une tige à trocart et un tube à panier pour tissus. Le tube à bistouri extérieur présente une arête de coupe distale, et la tige à trocart renferme un bistouri de pénétration. Le tube à panier définit au moins un orifice à tissu, lequel est en communication de fluide avec une source de vide. L'invention concerne également un procédé selon lequel le bistouri extérieur et le trocart pénètrent dans le patient et sont positionnés dans le tissu à prélever. La tige du trocart est retirée et le tube à panier est positionné dans la portion du tube à bistouri qui se trouve dans la portion du tissu à prélever. Le bistouri extérieur est alors retiré, exposant ainsi au moins l'orifice à tissu du tube à panier. Un vide est appliqué et le tube à panier est retiré dans le tube à bistouri en vue de sectionner et de transporter au moins un échantillon de tissu. Des échantillons supplémentaires peuvent être prélevés en repositionnant, comme requis, le tube à bistouri et en ramenant le tube à panier vers l'extrémité distale du tube à bistouri.
PCT/US2002/004998 2001-02-05 2002-02-04 Appareil de biopsie et procede y relatif WO2002062232A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26682501P 2001-02-05 2001-02-05
US60/266,825 2001-02-05

Publications (1)

Publication Number Publication Date
WO2002062232A1 true WO2002062232A1 (fr) 2002-08-15

Family

ID=30000230

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/004998 WO2002062232A1 (fr) 2001-02-05 2002-02-04 Appareil de biopsie et procede y relatif

Country Status (1)

Country Link
WO (1) WO2002062232A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2011253790B2 (en) * 2005-08-05 2013-04-04 Senorx, Inc Biopsy device with fluid delivery to tissue specimens
US8915864B2 (en) 2005-08-05 2014-12-23 Senorx, Inc. Biopsy device with fluid delivery to tissue specimens
US9408592B2 (en) 2003-12-23 2016-08-09 Senorx, Inc. Biopsy device with aperture orientation and improved tip
US10105125B2 (en) 2004-12-16 2018-10-23 Senorx, Inc. Biopsy device with aperture orientation and improved tip
CN113647996A (zh) * 2021-08-13 2021-11-16 中南大学湘雅二医院 一种椎体骨肿瘤采样装置

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2496111A (en) * 1947-09-26 1950-01-31 Turkel Henry Biopsy needle
US5161542A (en) * 1990-08-23 1992-11-10 Aubrey Palestrant Method for acquiring soft tissue biopsy specimens
US5560373A (en) * 1994-04-11 1996-10-01 De Santis; Stephen A. Needle core biopsy instrument with durable or disposable cannula assembly
WO1997024070A1 (fr) * 1995-12-28 1997-07-10 Jacques Phillibert Janssens Dispositif de prelevement d'echantillon de tissu
US6077230A (en) * 1998-05-14 2000-06-20 Ethicon Endo-Surgery, Inc. Biopsy instrument with removable extractor

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2496111A (en) * 1947-09-26 1950-01-31 Turkel Henry Biopsy needle
US5161542A (en) * 1990-08-23 1992-11-10 Aubrey Palestrant Method for acquiring soft tissue biopsy specimens
US5560373A (en) * 1994-04-11 1996-10-01 De Santis; Stephen A. Needle core biopsy instrument with durable or disposable cannula assembly
WO1997024070A1 (fr) * 1995-12-28 1997-07-10 Jacques Phillibert Janssens Dispositif de prelevement d'echantillon de tissu
US6077230A (en) * 1998-05-14 2000-06-20 Ethicon Endo-Surgery, Inc. Biopsy instrument with removable extractor

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9408592B2 (en) 2003-12-23 2016-08-09 Senorx, Inc. Biopsy device with aperture orientation and improved tip
US10105125B2 (en) 2004-12-16 2018-10-23 Senorx, Inc. Biopsy device with aperture orientation and improved tip
US11246574B2 (en) 2004-12-16 2022-02-15 Senorx, Inc. Biopsy device with aperture orientation and improved tip
AU2011253790B2 (en) * 2005-08-05 2013-04-04 Senorx, Inc Biopsy device with fluid delivery to tissue specimens
US8915864B2 (en) 2005-08-05 2014-12-23 Senorx, Inc. Biopsy device with fluid delivery to tissue specimens
US10064609B2 (en) 2005-08-05 2018-09-04 Senorx, Inc. Method of collecting one or more tissue specimens
US10874381B2 (en) 2005-08-05 2020-12-29 Senorx, Inc. Biopsy device with fluid delivery to tissue specimens
CN113647996A (zh) * 2021-08-13 2021-11-16 中南大学湘雅二医院 一种椎体骨肿瘤采样装置

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