WO2002062226A1 - Appareil et methode de biopsie - Google Patents

Appareil et methode de biopsie Download PDF

Info

Publication number
WO2002062226A1
WO2002062226A1 PCT/US2002/002931 US0202931W WO02062226A1 WO 2002062226 A1 WO2002062226 A1 WO 2002062226A1 US 0202931 W US0202931 W US 0202931W WO 02062226 A1 WO02062226 A1 WO 02062226A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
cutting element
biopsy apparatus
tissue
cutting
Prior art date
Application number
PCT/US2002/002931
Other languages
English (en)
Inventor
Hanspeter R. Bayer
Paul A. Scirica
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 WO2002062226A1 publication Critical patent/WO2002062226A1/fr

Links

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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter

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
  • biopsy The type of biopsy utilized depends in large part on the circumstances present with respect to the patient and no single procedure is ideal for all cases. Core biopsy, however, is extremely useful in a number of conditions and is being used more frequently. 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.
  • stereotactic x-ray, fluoroscopy, computer tomography, ultrasound, nuclear medicine and magnetic resonance imaging may be used.
  • 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.
  • One further solution to obtain a larger 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 expandable cutter with a hollow needle.
  • the needle contains at least one cutting element that in a first position defines a portion of the outside cylindrical circumference of the needle and in a second position forms an expanded cutting element with a cutting edge that rotates along the longitudinal axis of the needle.
  • the biopsy apparatus employs a vacuum through a central lumen draw tissue samples through the hollow needle and outer tube and is capable of multiple sequential tissue samples. The biopsy apparatus is returned to the first position prior to withdrawal from the patient.
  • a biopsy method is provided wherein a biopsy apparatus, including at least one cutting element that in a first position defines a portion of the outside cylindrical circumference of the needle and in a second position fo ⁇ ns an expanded cutting element with a cutting edge that rotates along the longitudinal axis of the needle.
  • FIG. 1A is a frontal perspective view of one configuration of the biopsy apparatus using an expandable needle with the cutting elements folded in a first position;
  • FIG. IB is a frontal perspective view of one configuration of the biopsy apparatus utilizing an expandable needle with the cutting elements expanded into an unfolded second position;
  • FIG. 1C is a side view of one configuration of the biopsy apparatus using an expandable needle with the cutting elements expanded into an unfolded second position
  • FIG. 2 A is a side view of a second configuration of the biopsy apparatus utilizing a needle with an expandable cutter with the cutting elements at least partially enclosed in an outer tube in a first position
  • FIG. 2B is a longitudinal cross sectional view of a second configuration of the biopsy apparatus utilizing an expandable cutter with the cutting elements expanded to a convex shape beyond the body of the needle.
  • biopsy apparatus 100 includes an outer tube 10, a hollow needle 20, and at least one expandable element 30.
  • biopsy apparatus 100 may include a housing wherein outer member 10, needle 20, and adjustable shutter like cutting mechanism 30 are housed.
  • the housing may include suitable known driving and actuating mechanisms.
  • penetrating member 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.
  • Outer tube 10 can be translated longitudinally along the "X" axis in both a proximal and a distal direction to expose or at least partially cover the at least one cutting elements 30 of needle 20 in a folded first position.
  • Outer tube 10 is preferably fabricated from a medical grade plastic.
  • Needle 20 can be rotated about the "X" axis within outer tube 10. Needle 20 and outer tube 10 are sufficiently sealingly engaged to preclude excessive vacuum losses. Hollow needle 20 is preferably made of a medical grade metal with a piercing tip.
  • the at least one cutting element 30 is positioned near the distal end of needle 20.
  • a longitudinal cutting edge 32 of the at least one cutting element 30 extends at least partially beyond the external circumference of needle 20.
  • Cutting element 30 defines a portion of the cylindrical circumference of needle 20 in a first position.
  • Biopsy apparatus 100 includes a vacuum source (not shown) to withdraw tissue samples.
  • the at least one cutting element 30 is preferably made of a medical grade metal having cutting edge 32 formed along the longitudinal edge thereof.
  • needle 20 is extended distally from distal end 12 along the "X" axis to expose the at least one cutting element 30.
  • the at least one cutting element 30 is pivotally connected to needle 20 by at least one pivot point 34.
  • a beveled proximal end is formed on the at least one cutting element 30 thereby defining cutting edge 32.
  • Biopsy apparatus 100 includes a vacuum source of sufficient power to draw a tissue sample from tissue port 25 through hollow needle 20 and hollow outer tube 10.
  • Cutting edge 32 is shown as a straight edge, but it can take the form of other shapes such as serrated.
  • biopsy apparatus 100 can be configured to engage cutting edge 32 upon counter-clockwise rotation or upon either a clockwise or counterclockwise rotation.
  • the at least one cutting element 30 contains a beveled proximal end 36.
  • Distal end 12 of outer tube 10 includes a flaring of the inside circumference that forms a bevel that is configured to interface with bevel 36.
  • the withdrawal of the distal end of needle 20 into outer tube 10 creates a cam type mechanical action on the at least one cutting element 30 thereby displacing cutting element 30 and returning cutting edge 32 into the folded position.
  • biopsy apparatus 100 or any of the other embodiments or configurations disclosed herein may be inserted by suitable known techniques. For example, biopsy apparatus 100 may be inserted by motor driver or spring fired mechanisms. Alternatively, biopsy apparatus 100 may be inserted manually.
  • biopsy apparatus 100 or any of the other embodiments or configurations 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 the initial first position biopsy apparatus 100 is configured for piercing with the at least one cutting element 30 at least partially enclosed within outer tube 10 and the tip of needle 20 exposed.
  • outer tube 10 is withdrawn proximally from a first position at least partially covering the at least one cutting element 30 to a second position exposing a sufficient length of needle 20 for at least one cutting element 30 to be fully exposed.
  • a rotation of needle 20 in a clockwise direction about longitudinal axis "X" engages the at least one edge 32 with the tissue of the patient to be sampled, rotating the at least one cutting element 30 into an expanded open position.
  • the continued rotation of needle 20 along longitudinal axis "X" engages cutting edge 32 of the at least one cutting element 30 with the patient's tissue. If one cutting element 30 is used, rotation of needle 20 through 360° after cutting element 30 has been deployed will result in the cutting of a tissue sample from the patient. It is envisioned that if any number of cutting elements greater than one is used, that a rotation of needle 20 through an angle equal to 360° divided by the total number of cutting elements will be sufficient to completely sever a sample of tissue from the patient.
  • the tissue sample can then be withdrawn through the biopsy apparatus 100 by applying a vacuum to tissue port 25 through the center of outer tube 10 and hollow needle 20. Biopsy apparatus 100 can then be repositioned for a second sampling or withdrawn from the patient all together.
  • Biopsy apparatus 200 includes an outer tube 210, a needle 220, and at least one expandable element 230.
  • Needle 220 includes a distal end 222 having a needle tip, a proximal end 224, and a shaft 226.
  • Distal end 222 and proximal end 224 are connected by at least one cutting element 230.
  • distal end 222 contains a longitudinal reduced diameter shaft 226 extending proximally through proximal end 224 and outer tube 210.
  • the at least one cutting element 230 is a bendable metallic strip or wire that connects distal end 222 with proximal end 224 and forms a tissue port 225.
  • Outer tube 210 can be translated longitudinally along the "X" axis in both a proximal and a distal direction to expose or at least partially cover the at least one cutting element 230 with a longitudinal length Dl .
  • a longitudinal edge 232 of the at least one cutting element 230 defines a portion of the cylindrical circumference of needle 220 in a first position.
  • Biopsy apparatus 200 includes a vacuum source (not shown) to withdraw tissue samples. Needle 220 can be rotated about the "X" axis within outer tube 210. Needle 220 and outer tube 210 are sufficiently sealingly engaged to preclude excessive vacuum losses.
  • the preformed shape of cutting element 230 could take a variety of geometric shapes upon compression such as triangular, square, or trapezoidal, for example, that could be advantageous in differing tissue sampling locations and conditions.
  • the at least one cutting element 230 is configured with a cutting edge 232 along one or both edges that can also include serrations, or other similar devices to enhance the cutting of tissue samples, depending on the desired application.
  • needle 220 is in the second position, with the at least one cutting edge 232 in the expanded convex shape, needle 220 can be rotated through 360° about the "X" axis in order to cut a tissue sample.
  • Biopsy apparatus 200 includes a vacuum of sufficient power that it can draw a tissue sample from tissue port 225 through hollow needle 220 and outer tube 210.
  • biopsy apparatus 200 in the initial first position biopsy apparatus 200 is configured for piercing with at least one cutting element 230 at least partially enclosed within outer tube 210 and the tip of needle 220 exposed.
  • outer tube 210 is withdrawn proximally from the first position at least partially covering the at least one cutting element 230 to the second position exposing sufficient length of needle 220 for the at least one cutting element 230 to be fully exposed.
  • the application of a distal force upon proximal end 224 while holding distal end 222 via shaft 226 in position then translates at least one cutting element 230 from a first position within the outer circumference of needle 220 to a second position expanding the at least one cutting element beyond the circumference of needle 220 into a convex shape by placing the at least one cutting element 230 in compression.
  • Needle 220 including the at least one cutting element 230 having cutting edge 232 can then be rotated about longitudinal axis "X" to engage the surrounding tissue.
  • the continued rotation of needle 220 about the longitudinal axis "X" through a 360° rotation cuts a tissue sample from the patient that is retained in tissue port 225.
  • the tissue sample can then be withdrawn from tissue port 225 through the biopsy apparatus 200 by placing a vacuum through hollow outer tube 210 and needle 220.
  • Biopsy apparatus 200 can then be repositioned for a second sampling or withdrawn from the patient.
  • the withdrawal of biopsy apparatus 200 includes proximally extending proximal end 224 while holding shaft 226 and distal end 222 in position.
  • This force translates at least one cutting element 230 from the expanded cutting element convex shaped second position to the first position of the at least one cutting element 230 within the circumference of needle 220 by placing proximal end 224 under tension along the longitudinal axis "X.” Once the at least one cutting element 230 is in its first position within the circumference of needle 220, needle 220 can then be withdrawn into outer tube 210 and biopsy apparatus 200 then withdrawn from the patient.

Abstract

L'invention concerne un appareil de biopsie servant à prélever un échantillon interne chez un patient, équipé d'une aiguille comprenant au moins un élément tranchant qui, dans une première position, définit une partie de la circonférence cylindrique extérieure de l'aiguille et, dans une seconde position, s'étend au-delà de la circonférence de l'aiguille pour former une configuration allongée de découpe de tissu. L'invention concerne également une méthode dans laquelle un appareil de biopsie est positionné au moins partiellement dans une partie de tissu destinée à être prélevée. L'élément tranchant s'étend d'une première position pliée à une seconde position de découpe, et un vide est appliqué afin d'augmenter le prolapsus du tissu. L'appareil effectue une rotation pour séparer un échantillon de tissu. La source de vide retire l'échantillon tissulaire du tissu par la partie creuse de l'aiguille et le tube extérieur creux. De multiples échantillons séquentiels peuvent alors être prélevés, ou l'appareil de biopsie peut être placé dans la première position puis retiré du patient.
PCT/US2002/002931 2001-02-05 2002-02-01 Appareil et methode de biopsie WO2002062226A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26682201P 2001-02-05 2001-02-05
US60/266,822 2001-02-05

Publications (1)

Publication Number Publication Date
WO2002062226A1 true WO2002062226A1 (fr) 2002-08-15

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Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010151250A1 (fr) 2008-06-23 2010-12-29 Microfabrica Inc. Outil de broyage miniature pour application médicale
EP2280657A1 (fr) * 2008-06-05 2011-02-09 Cardiovascular Systems, Inc. Tête à dilatation bidirectionnelle pour dispositif rotatif d'athérectomie
US7909850B2 (en) 1999-10-25 2011-03-22 Boston Scientific Scimed, Inc. Forceps for medical use
US7942896B2 (en) 2003-11-25 2011-05-17 Scimed Life Systems, Inc. Forceps and collection assembly and related methods of use and manufacture
US8083686B2 (en) 2003-09-10 2011-12-27 Boston Scientific Scimed, Inc. Forceps and collection assembly with accompanying mechanisms and related methods of use
WO2013168166A1 (fr) * 2012-05-10 2013-11-14 Arch Medical Devices Ltd. Aiguille de biopsie ayant une partie distale latéralement expansible
US9290854B2 (en) 2013-07-16 2016-03-22 Microfabrica Inc. Counterfeiting deterrent and security devices, systems and methods
US9451977B2 (en) 2008-06-23 2016-09-27 Microfabrica Inc. MEMS micro debrider devices and methods of tissue removal
US9814484B2 (en) 2012-11-29 2017-11-14 Microfabrica Inc. Micro debrider devices and methods of tissue removal
US10064644B2 (en) 2008-06-23 2018-09-04 Microfabrica Inc. Selective tissue removal tool for use in medical applications and methods for making and using
WO2019173509A1 (fr) * 2018-03-06 2019-09-12 Viant As&O Holdings, Llc Tête de coupe d'alésoir extensible
US10492822B2 (en) 2009-08-18 2019-12-03 Microfabrica Inc. Concentric cutting devices for use in minimally invasive medical procedures
US10676836B2 (en) 2003-06-27 2020-06-09 Microfabrica Inc. Electrochemical fabrication methods incorporating dielectric materials and/or using dielectric substrates
US10939934B2 (en) 2008-06-23 2021-03-09 Microfabrica Inc. Miniature shredding tools for use in medical applications, methods for making, and procedures for using

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1867624A (en) * 1930-04-01 1932-07-19 Memorial Hospital For The Trea Device for obtaining biopsy specimens
US3683892A (en) * 1970-07-13 1972-08-15 Battelle Development Corp Device for the extraction of core samples
WO1989005608A1 (fr) * 1987-12-19 1989-06-29 Coats Viyella Medical Limited Aiguille biopsique
US5794626A (en) * 1994-08-18 1998-08-18 Kieturakis; Maciej J. Excisional stereotactic apparatus
EP0983749A2 (fr) * 1998-09-03 2000-03-08 Rubicor Medical, Inc. Dispositifs et méthodes pour biopsie d'excision

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1867624A (en) * 1930-04-01 1932-07-19 Memorial Hospital For The Trea Device for obtaining biopsy specimens
US3683892A (en) * 1970-07-13 1972-08-15 Battelle Development Corp Device for the extraction of core samples
WO1989005608A1 (fr) * 1987-12-19 1989-06-29 Coats Viyella Medical Limited Aiguille biopsique
US5794626A (en) * 1994-08-18 1998-08-18 Kieturakis; Maciej J. Excisional stereotactic apparatus
EP0983749A2 (fr) * 1998-09-03 2000-03-08 Rubicor Medical, Inc. Dispositifs et méthodes pour biopsie d'excision

Cited By (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7909850B2 (en) 1999-10-25 2011-03-22 Boston Scientific Scimed, Inc. Forceps for medical use
US10676836B2 (en) 2003-06-27 2020-06-09 Microfabrica Inc. Electrochemical fabrication methods incorporating dielectric materials and/or using dielectric substrates
US8083686B2 (en) 2003-09-10 2011-12-27 Boston Scientific Scimed, Inc. Forceps and collection assembly with accompanying mechanisms and related methods of use
US8460205B2 (en) 2003-09-10 2013-06-11 Boston Scientific Scimed, Inc. Forceps and collection assembly with accompanying mechanisms and related methods of use
US7942896B2 (en) 2003-11-25 2011-05-17 Scimed Life Systems, Inc. Forceps and collection assembly and related methods of use and manufacture
US9186170B2 (en) 2008-06-05 2015-11-17 Cardiovascular Systems, Inc. Bidirectional expandable head for rotational atherectomy device
EP2280657A1 (fr) * 2008-06-05 2011-02-09 Cardiovascular Systems, Inc. Tête à dilatation bidirectionnelle pour dispositif rotatif d'athérectomie
EP2280657A4 (fr) * 2008-06-05 2013-10-16 Cardivascular Systems Tête à dilatation bidirectionnelle pour dispositif rotatif d'athérectomie
US10064644B2 (en) 2008-06-23 2018-09-04 Microfabrica Inc. Selective tissue removal tool for use in medical applications and methods for making and using
US9907564B2 (en) 2008-06-23 2018-03-06 Microfabrica Inc. Miniature shredding tool for use in medical applications and methods for making
US8968346B2 (en) 2008-06-23 2015-03-03 Microfabrica Inc. Miniature shredding tool for use in medical applications and methods for making
US10939934B2 (en) 2008-06-23 2021-03-09 Microfabrica Inc. Miniature shredding tools for use in medical applications, methods for making, and procedures for using
EP2326266A1 (fr) * 2008-06-23 2011-06-01 Microfabrica Inc. Outil de broyage miniature pour application médicale
US9451977B2 (en) 2008-06-23 2016-09-27 Microfabrica Inc. MEMS micro debrider devices and methods of tissue removal
WO2010151250A1 (fr) 2008-06-23 2010-12-29 Microfabrica Inc. Outil de broyage miniature pour application médicale
EP2326266A4 (fr) * 2008-06-23 2014-08-20 Microfabrica Inc Outil de broyage miniature pour application médicale
US10492822B2 (en) 2009-08-18 2019-12-03 Microfabrica Inc. Concentric cutting devices for use in minimally invasive medical procedures
US9655596B2 (en) 2012-05-10 2017-05-23 Arch Medical Devices Ltd. Biopsy needle with a laterally expandable distal portion
WO2013168166A1 (fr) * 2012-05-10 2013-11-14 Arch Medical Devices Ltd. Aiguille de biopsie ayant une partie distale latéralement expansible
US9814484B2 (en) 2012-11-29 2017-11-14 Microfabrica Inc. Micro debrider devices and methods of tissue removal
US9567682B2 (en) 2013-07-16 2017-02-14 Microfabrica Inc. Counterfeiting deterrent and security devices, systems, and methods
US9290854B2 (en) 2013-07-16 2016-03-22 Microfabrica Inc. Counterfeiting deterrent and security devices, systems and methods
US10801119B2 (en) 2013-07-16 2020-10-13 Microfabrica Inc. Counterfeiting deterrent and security devices, systems, and methods
WO2019173509A1 (fr) * 2018-03-06 2019-09-12 Viant As&O Holdings, Llc Tête de coupe d'alésoir extensible
US11083470B2 (en) 2018-03-06 2021-08-10 Viant As&O Holdings Llc Expandable reamer cutting head

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