WO2002062228A1 - Appareil et methode de biopsie - Google Patents

Appareil et methode de biopsie Download PDF

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Publication number
WO2002062228A1
WO2002062228A1 PCT/US2002/002987 US0202987W WO02062228A1 WO 2002062228 A1 WO2002062228 A1 WO 2002062228A1 US 0202987 W US0202987 W US 0202987W WO 02062228 A1 WO02062228 A1 WO 02062228A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
vacuum
trocar rod
knife tube
biopsy apparatus
Prior art date
Application number
PCT/US2002/002987
Other languages
English (en)
Inventor
Csaba Rethy
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 WO2002062228A1 publication Critical patent/WO2002062228A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other 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
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other 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
    • A61B10/02—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
    • A61B10/00—Other 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
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0225—Instruments for taking cell samples or for biopsy for taking multiple samples

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 with a distal end cutter and a trocar rod removably positioned within the knife tube.
  • the trocar rod includes a piercing tip and at least one tissue basket near the distal end.
  • the at least one tissue basket contains a plurality of through holes that are in fluid communication with at least one vacuum passageway positioned in the trocar rod and a vacuum source.
  • a biopsy method is provided wherein a biopsy apparatus employing an outer hollow knife tube with a distal end cutter and an inner trocar rod with a piercing tip and at least one tissue basket, penetrates a patient's tissue and is at least partially positioned within the tissue to be sampled.
  • the hollow tube is withdrawn proximally while the trocar rod is held in position to at least partially expose the at least one tissue port to the tissue to be sampled.
  • a vacuum is applied to assist the natural prolapse of tissue into the at least one tissue port and the trocar rod is held in a substantially fixed position while the hollow knife tube is repositioned and the distal end cutter severs a tissue sample.
  • the trocar rod transports the at least one tissue sample through the hollow knife tube.
  • FIG. 1 is a perspective view of one embodiment of the knife tube and trocar rod biopsy apparatus constructed in accordance with the present disclosure
  • FIG. 2 is an axial cross sectional view of the biopsy apparatus of FIG. 1 taken along section line 2-2;
  • FIG. 3 is an axial cross sectional view of a second embodiment of the knife tube and trocar rod biopsy apparatus with a vacuum tube and tissue basket through hole configuration that selectively controls the application of the vacuum to the tissue baskets constructed in accordance with the present disclosure
  • FIG. 4 is an axial cross section view of a third embodiment of the knife tube and trocar rod biopsy apparatus with at least two vacuum passageways constructed in accordance with the present disclosure.
  • biopsy apparatus 100 includes a knife tube 10 and a trocar rod 20.
  • Knife tube 10 includes a distal end 12 and a proximal end 14 wherein tubular wall 16, distal end 12 and proximal end 14 define a lumen concentric to the axis "X."
  • Distal end 12 contains a cutting edge 15.
  • Trocar rod 20 includes a distal end 22 with an integrated piercing tip or knife blade tip 23 and a proximal end 24. Distal end 22 and proximal end 24 define a longitudinal axis "X" that is concentric with that of knife tube 10. Trocar rod 20 is sealingly engaged and removably positioned within knife tube 10.
  • biopsy apparatus 100 may include a housing wherein knife tube 10 and trocar rod 20 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.
  • Cutting edge 15 has the function of piercing the outer tissue of the patient and severing tissue samples in combination with trocar rod 20.
  • 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 of stainless steel.
  • Trocar rod tube 20 wall segments 26 slidingly engage knife tube 10 and define at least one tissue port near distal end 22. As shown in this embodiment, three walls segments 26 define three tissue ports 25, but the quantity, dimensions, location, and configuration of tissue ports 25 is dependent upon the particular application of the knife tube and trocar rod biopsy apparatus 100.
  • Each tissue port 25 contains a concave interior wall 28 that defines a tissue basket 27 and a plurality of vacuum through holes 29. Interior walls 28 also define a vacuum passageway 21 that is in fluid communication with a vacuum source (not shown) and through holes 29.
  • Trocar rod 20 is fabricated as a solid rod injection molded of a polycarbonate, similarly suitable composite materials, or medical grade metals. Knife blade tip 23 is preferably fabricated from stainless steel by a suitable process, such as stamping or metal injection molding.
  • biopsy apparatus 100 is shown along cross section 2-2 in FIG. 1 with trocar rod 20 positioned concentrically within knife tube 10.
  • Wall 26 slidingly engages the interior circumference of knife tubular wall 16.
  • Interior walls 28 define tissue basket 27, through holes 29, and passageway 21.
  • FIG. 3 alternative configuration biopsy apparatus 200 is shown with a trocar rod 220 positioned within a knife tube 210. At least one wall segment 226 slidingly engages an interior circumference of tubular wall 216. Walls 228 define at least one tissue basket 227, a plurality of through holes 229, and a passageway 221 that is aligned with the longitudinal axis "X".
  • a vacuum tube 230 is removably positioned within and sealingly engaged with vacuum passageway 221. Vacuum tube 230 includes a tubular wall 236 that defines a plurality of radially and longitudinally aligned through holes 239 that are in fluid communication with tissue basket 227 and a vacuum source (not shown).
  • the interior walls 228 define a plurality of longitudinally aligned through holes 229.
  • the length of the preset interval between through holes 229 of tissue baskets 227 are equidistant along the longitudinal axis, but through holes 229 of each tissue basket 227 have a distinct and separate radial alignment.
  • vacuum tube 230 provides the function of selectively directing the orientation of the vacuum to a single tissue basket, depending on its preset position within trocar rod 220, in order to optimize the application of the instrument to a variety of operational scenarios.
  • Further alternative configurations could include radially aligning through holes 239 and 229 to establish fluid communication with at least two tissue baskets simultaneously, for example. This configuration could also include an increased number of radially positioned tissue baskets.
  • Trocar rod 320 includes a wall segment 326 that slidingly engages the interior circumference of tubular wall 316.
  • Interior walls 328 define at least one tissue basket 327, a plurality of through holes 329, and a primary vacuum passageway 321.
  • Primary vacuum passageway 321 contains at least one member 322 that divides primary vacuum passageway 321 into at least one additional secondary passageway 323.
  • the quantity and orientation of secondary passageways 323 corresponds to the quantity and radial orientation of the at least one tissue basket 327 positioned in trocar rod 320.
  • Passageways 323 provide the function of selectively controlling the application of the vacuum to the at least one tissue basket that has a preferred orientation for the tissue to be sampled.
  • the vacuum applied to each secondary passageway 323 could be from separate vacuum sources, for example, or from a single vacuum source with a switch system for selecting at least one secondary vacuum passageway 323 that corresponds to the desired tissue basket and tissue sampling location.
  • Biopsy apparatus 100 or any of the other biopsy apparatus embodiments or configurations disclosed herein may be inserted by suitable known techniques, for example, by motor driven 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 operation pierces the tissue of a patient in a first position wherein trocar rod 20 is concentrically positioned and sealingly engaged within knife tube 10. Biopsy apparatus 100 is then at least partially positioned within a tissue portion.
  • trocar rod can be rotatingly positioned within knife tube 10 or have a fixed orientation that is controlled from proximal end 24 wherein a first tissue basket is relatively aligned at a "12:00 o'clock" position, a second tissue basket is relatively aligned at a "4:00 o'clock” position, and a third tissue basket is relatively aligned at an "8:00 o'clock" position.
  • knife tube 10 is withdrawn proximally to at least partially expose tissue basket 27.
  • the prolapse of tissue portion into tissue port 25 is augmented by the application of the vacuum communicated from the vacuum source through passageway 21 to holes 29 defined in the wall 26 of tissue basket 27.
  • Knife tube 10 is then repositioned by translating or using a combined movement rotating and translating edge 15 over tissue basket 27 to sever at least one tissue sample.
  • knife tube 10 is withdrawn proximally it is then held substantially in the same position while trocar rod 20 is withdrawn proximally to sever at least one tissue sample against cutting edge 15. The at least one severed tissue sample is retained within the respective at least one tissue basket 27.
  • Trocar rod 20 is then withdrawn proximally through knife tube 10. Additional tissue samples are obtained by radially repositioning the at least one tissue basket 27 within knife tube 10 or repositioning knife tube 10 and trocar rod 20 simultaneously radially or longitudinally. Tissue samples obtained from trocar rod 20, when employed with a fixed angular orientation, are segregated to reduce contamination and as a result of their controlled directional orientation, have the advantage that the samples may indicate a direction of malignancy.

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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 permettant de prélever des échantillons de tissus internes, équipé d'un tube tranchant extérieur et d'un trocart comprenant au moins un logement de tissu et une pointe de perçage. Les logements de tissu sont alignés de façon radiale autour de l'axe longitudinal près de l'extrémité distale. La pointe de l'aiguille est positionnée à l'extrémité distale du trocart et perce le tissu du patient. Le tube tranchant extérieur comprend un bord distal tranchant et le trocart contient une lame tranchante destinée à pénétrer un tissu externe du patient. Le logement de tissu est en communication fluidique avec une source de vide par l'intermédiaire d'un passage à vide dans le trocart. L'invention concerne également une méthode selon laquelle le tube tranchant extérieur et le trocart pénètrent le patient et sont positionnés dans le tissu destiné à être prélevé. Le tube tranchant est retiré, exposant au moins partiellement le logement de tissu du trocart. Un vide est appliqué et le trocart maintenu sensiblement stationnaire pendant que le tube tranchant est repositionné de manière distale pour séparer l'échantillon de tissu. Des échantillons supplémentaires peuvent être prélevés par application d'un vide sur un différent logement de tissu ou par repositionnement du trocart dans le tube tranchant selon une nouvelle orientation ou position radiale le long de l'axe longitudinal. Les échantillons de tissu sont retirés par le tube tranchant avec le trocart.
PCT/US2002/002987 2001-02-05 2002-02-01 Appareil et methode de biopsie WO2002062228A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26680601P 2001-02-05 2001-02-05
US60/266,806 2001-02-05

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WO2002062228A1 true WO2002062228A1 (fr) 2002-08-15

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004010874A1 (fr) * 2002-07-26 2004-02-05 Brown Stuart B Dispositif d'echantillonnage de tissu et de fluide
WO2012012573A1 (fr) * 2010-07-22 2012-01-26 Hologic Inc. Jeu d'aiguilles pour dispositif de biopsie et méthode associée
AU2011253790B2 (en) * 2005-08-05 2013-04-04 Senorx, Inc Biopsy device with fluid delivery to tissue specimens
CN103767740A (zh) * 2014-01-24 2014-05-07 德迈特医学技术（北京）有限公司 多槽切割式活检装置
US8915864B2 (en) 2005-08-05 2014-12-23 Senorx, Inc. Biopsy device with fluid delivery to tissue specimens
EP2224856A4 (fr) * 2007-10-25 2017-05-24 Epitome Pharmaceuticals Limited Aiguille à biopsie de dissociation cellulaire
CN109498070A (zh) * 2019-01-04 2019-03-22 山东省肿瘤防治研究院（山东省肿瘤医院） 一种用于乳腺肿瘤微创手术的多点活检取样装置

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997024070A1 (fr) * 1995-12-28 1997-07-10 Jacques Phillibert Janssens Dispositif de prelevement d'echantillon de tissu
EP0919192A2 (fr) * 1997-11-24 1999-06-02 Ethicon Endo-Surgery, Inc. Instrument de biopsie avec pointe pour dilatation de tissue
US5944673A (en) * 1998-05-14 1999-08-31 Ethicon Endo-Surgery, Inc. Biopsy instrument with multi-port needle
US6050955A (en) * 1997-09-19 2000-04-18 United States Surgical Corporation Biopsy apparatus and method

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997024070A1 (fr) * 1995-12-28 1997-07-10 Jacques Phillibert Janssens Dispositif de prelevement d'echantillon de tissu
US6050955A (en) * 1997-09-19 2000-04-18 United States Surgical Corporation Biopsy apparatus and method
EP0919192A2 (fr) * 1997-11-24 1999-06-02 Ethicon Endo-Surgery, Inc. Instrument de biopsie avec pointe pour dilatation de tissue
US5944673A (en) * 1998-05-14 1999-08-31 Ethicon Endo-Surgery, Inc. Biopsy instrument with multi-port needle

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004010874A1 (fr) * 2002-07-26 2004-02-05 Brown Stuart B Dispositif d'echantillonnage de tissu et de fluide
US7740595B2 (en) 2002-07-26 2010-06-22 Stuart Brown Tissue and fluid sampling device
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
EP2224856A4 (fr) * 2007-10-25 2017-05-24 Epitome Pharmaceuticals Limited Aiguille à biopsie de dissociation cellulaire
WO2012012573A1 (fr) * 2010-07-22 2012-01-26 Hologic Inc. Jeu d'aiguilles pour dispositif de biopsie et méthode associée
CN103767740A (zh) * 2014-01-24 2014-05-07 德迈特医学技术（北京）有限公司 多槽切割式活检装置
CN109498070A (zh) * 2019-01-04 2019-03-22 山东省肿瘤防治研究院（山东省肿瘤医院） 一种用于乳腺肿瘤微创手术的多点活检取样装置

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