WO1993004629A1 - Instrument de biopsie avec bord tranchant affute et presentant une courbure - Google Patents

Instrument de biopsie avec bord tranchant affute et presentant une courbure Download PDF

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Publication number
WO1993004629A1
WO1993004629A1 PCT/US1992/007245 US9207245W WO9304629A1 WO 1993004629 A1 WO1993004629 A1 WO 1993004629A1 US 9207245 W US9207245 W US 9207245W WO 9304629 A1 WO9304629 A1 WO 9304629A1
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WO
WIPO (PCT)
Prior art keywords
cannula
cutting edge
tissue
radius
biopsy instrument
Prior art date
Application number
PCT/US1992/007245
Other languages
English (en)
Inventor
Richard A. Terwilliger
Original Assignee
Terwilliger Richard A
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 Terwilliger Richard A filed Critical Terwilliger Richard A
Publication of WO1993004629A1 publication Critical patent/WO1993004629A1/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

Definitions

  • This invention relates to an automated mechanism for collecting a tissue sample from humans or animals by a procedure referred to as tissue biopsy, and more particularly to an instrument for automatically performing the tissue extraction from a 25 tissue mass in a precise and rapid manner with minimum patient discomfort.
  • Tumors are first noted in a patient by one 35 of three ways. These ways include palpation, X-ray
  • tissue biopsy is performed to establish whether cells are cancerous.
  • Biopsy may be done by an open or closed technique. Open biopsy removes the entire tissue mass or a part of the tissue mass. Closed biopsy on the other hand is usually performed with a needle-like instrument and may be either an aspiration biopsy (hollow needle on a syringe) or a cored biopsy (special tissue cutting needle design) .
  • aspiration biopsy individual cells or clusters of cells are obtained for cytologi ⁇ examination.
  • core biopsy a segment of tissue is obtained for histologic examination, which may be done as a frozen section or paraffin section.
  • tissue samples for cytologi ⁇ or histologic examination have been performed historically by manual insertion and manipulation of the needle. These procedures are performed blind by the physician and guided by feel and known, anatomic landmarks.
  • One prior art manual biopsy device includes a syringe arrangement including a stylet surrounded by a cannula.
  • the stylet has a pointed tip and behind the tip a reduced diameter shank.
  • the diameter of the pointed tip is slightly less than the internal diameter of the cannula such that the tip prevents tissue from entering the cannula as the cannula is passed through surrounding tissue to the point of intended biopsy.
  • An O-ring is placed in sealing relationship between the reduced diameter shank and the internal diameter of the cannula.
  • the cannula is urged forward past the tip of the stylet in order to collect a tissue sample. As this occurs, a vacuum is formed in the cannula between the O-ring and the tissue sample. This vacuum tends to draw the tissue sample into the cannula.
  • This device however, has disadvantages in that it is manual and thus does not give totally reliable results, as discussed below, in taking a biopsy of a very small tumor.
  • tissue harvesting devices have been described in United States Patent Nos. 4,651,752; 4,702,260; and 4,243,048.
  • Two very important innovations in medical technology have influenced the field of tissue biopsy in the last five years.
  • One is the use of tissue imaging devices which allow the physician to see inside the body and visually guide the needle to the tumor mass.
  • the second is the invention of the
  • ACBD Automatic Core Biopsy Device
  • the Automated Core Biopsy Device allows a biopsy to be performed on tumor masses as small as two millimeters in diameter. This procedure is performed under ultrasound or X-ray guidance. Tumors of this size cannot be biopsied reliably by hand since the tumor is about the same size as the biopsy needle. Manual attempts at biopsy pushes the tumor away without piercing the mass. Automatic puncture devices accelerate the needle at such a velocity that even a small tumor can be pierced. Automated Core Biopsy Devices (ACBD) use the True Cut needle set design.
  • the True Cut needle is comprised of an inner notched stylet 17 (Fig. 5a) with an outer cannula 16 (Fig. 5a) .
  • the stylet is advanced into the tissue under spring power followed by the cannula which cuts and traps the tissue sample 18 (Figs. 5a , 6) in the notch of the stylet.
  • the True Cut needle yields a core tissue sample 18 which is semi-circular in cross-section with a length determined by the stroke of the ACBD.
  • the stylet is a needle with a notched cut ⁇ out at the distal end.
  • the cannula is a hollow needle with an angled cutting surface at the distal end which slides over the stylet. When the stylet is pushed into the tissue, the tissue is pierced and relaxes into the notched cut-out. When the cannula is slid forward, the tissue in the notch of the stylet is sliced off and retained in the notch until the cannula is drawn back.
  • ACBD's is 18 gage.
  • the use of 18 gage needles is a compromise between the physician's desire to use the smallest, least invasive, needle gage and the pathologist's needs for as large a tissue sample as possible to minimize false-positive diagnosis .
  • This compromise in needle size leads the physician to obtain multiple core samples from the biopsy site to allow the pathologist sufficient tissue for an accurate diagnosis.
  • the requirements of the physician and the pathologist dictate the need for an alternative approach in the function and design of the conventional ACBD and needle sets.
  • the ideal product would allow the use of smaller needle gages and/or lessen the need for multiple samples to be taken from a given biopsy site.
  • the instrument is a spring powered mechanical design.
  • the needle set is integral with the housing and consists of a outer hollow cannula- and an inner pointed tipped stylet.
  • the stylet and the cannula are driven forward under spring force in a defined motion in relation to each other.
  • the housing is comprised of a hollow tube which guides a spring backed piston to which the cannula and stylet are attached.
  • the piston is pushed backwards in a chamber described by this housing by means of an outer actuator which compresses the main spring.
  • a locking means holds the piston and main spring in the compressed state in which the inner stylet is positioned inside the cannula and protrudes out of the distal end of said cannula.
  • the piston and cannula are driven forward.
  • the stylet is pushed in the opposite direction by a secondary spring on the far side of the piston until a stop is reached, at which point the stylet stops the backward motion and tracks the forward motion of the advancing cannula for the rest of the movement of the cannula.
  • the piston comes to rest against a block which incorporates an "O" ring seal.
  • the chamber in which the piston moves is sealed at the distal end of the device by an end cap with integral seal and at the proximal end by a block with the integral seal.
  • the chamber is sealed by the spring loaded position of the piston against said block, allowing only the hollow bore of the cannula as an exit.
  • the tissue advances up into the hollow bore of the cannula created by the backward motion of the stylet.
  • the cannula advances a defined distance into the tissue, at which point the inner stylet stops the backward motion and begins to follow the cannula, stopping the relative motion of the stylet with respect to the cannula. Since the cannula continues the forward motion and the hollow bore is filled with pierced tissue backed up against the stylet, the further advancement of the cannula slices off the captured tissue trapped inside of the cannula from the surrounding tissue at the distal end of the cannula.
  • the present design ensures that no matter if a soft or a firm tissue sample is being taken, the inventive device reliably slices off the tissue sample so that the tissue sample is not left in the patient when the cannula is removed.
  • the inventative instrument includes a radius ground cutting edge provided on the end of the cannula.
  • This radius ground cutting edge defines a V- shaped portion which greatly enhances tissue severability with respect to prior art cutting edges which essentially have an oval aperture.
  • the captured tissue With the tissue sliced off at the tip of the distal end of the cannula and the piston sealed against the inner "0" ring seal of the block, the captured tissue remains positioned in the hollow bore of the cannula as the needle is withdrawn from the surrounding tissue.
  • the captured tissue acts as the final seal of the chamber created by the housing and the associated internal parts ensuring that the tissue sample is held in the cannula as the cannula is withdrawn from the patient.
  • the stylet is a pointed needle positioned inside the cannula. At the distal end of the stylet, a pointed tip facilitates the introduction of the needles into the tissue mass.
  • the stylet is positioned flush to the end of the cannula in the cocked positioned. In the cocked position, the stylet prevents tissue from entering the cannula as the needle set is introduced into the body.
  • the cannula advances while the stylet moves in the opposite direction, thus allowing space for the penetrated tissue to enter the cannula.
  • the cannula is moved backwards over the stylet, pushing the tissue sample out of the cannula. This action removes the tissue sample and cocks the device in one motion.
  • the cylindrical core volume of this invention is 72% larger than that provided by the True Cut needle set.
  • a 20 gage cylindrical needle in accordance with this invention will yield 71% of the tissue yielded by an 18 gage True Cut needle set.
  • tissue sampling device for obtaining tissue samples which have a circular cross-section.
  • Such a cross-section provides for more tissue mass for a given needle gage, provides for a less invasive procedure with reduced tissue trauma and allows for the maximum tissue to be harvested with the minimum number of samples taken.
  • Figs, la, lb and lc are cross-sectional side elevation views of the biopsy instrument of the invention.
  • Fig. la depicts the device in the "fired” position
  • Fig. lb depicts the device in the process of being “cocked” with the thumb knob pushed rearwardly
  • Fig. lc depicts the device in the "cocked” position
  • Fig. 2 is a partial side elevation of the needle at its distal end
  • Figs. 3a, 3b, 3c and 3d are pictorial illustrations of needle positions in various stages of the operation of an embodiment of the invention.
  • Fig. 4a is a pictorial illustration of the preferred embodiment of the distal needle end of the invention.
  • Fig. 4b is a pictorial illustration of the cross-section of tissue obtained from the preferred embodiment of this invention.
  • Fig. 5a is a pictorial illustration of the distal needle end of the prior art
  • Fig. 5b is a pictorial illustration of the cross-section of tissue obtained from the prior art.
  • Figs. 6a and 6b depict side and plan views of the distal end of a prior art cannula showing a conventional straight ground cutting edge.
  • Figs. 7a and 7b depict side and plan views of an embodiment of the present invention wherein the distal end of the cannula is provided with an aperture defined by a radius ground cutting edge.
  • Fig. 8 depicts a side view of the stylet projecting through the inventative cannula aperture with the radius ground cutting edge of Fig. 7a.
  • Fig. la illustrates a side elevation view of the embodiment of the inventive biopsy instrument which is shown to depict the main components of said embodiment with the main body or housing is shown generally at 1 and the tissue piercing and removal means shown by stylet 11 and cannula 13.
  • the main housing means extends from end cap 7 to the distal end of thumb knob 4.
  • Within said housing 1 is a plunger block 2.
  • Plunger rod 3 is depressed by exerting pressure on thumb knob 4 which compresses the main spring 5.
  • Plunger 2 and main spring 5 are held in the compressed state by latch pin 12 which resides in actuator button 8.
  • Spring 9 pushes actuator button 8 and latch pin 12 up against plunger rod 3.
  • latch pin 12 slides along plunger rod 3 until latch pin 12 detents into the annular groove in plunger rod 3 (Fig. lb) .
  • Latch pin 12 holds plunger rod 3 in place and thus holds plunger 2 and main spring 5 in compression until such time that actuator button 8 is depressed.
  • the spring 14 returns thumb knob 4 to an initial position against stop 23 of the main body 1 (Fig. lc).
  • plunger rod 3 When the actuator button 8 is depressed, plunger rod 3 is released and main spring 5 pushes plunger 2 forward with the associated component cannula 13 which is attached to plunger 2.
  • Cannula 13 is fixed to plunger 2 through a hole in plunger 2 is sealed in the hole and communicates with an inner chamber 21 defined by the inside of housing 1.
  • Plunger 2 when in contact with "O" ring seal 10, and end cap 7 with associated "O" ring seal 6, create an air tight inner chamber 21 of main housing 1 with the hollow body of cannula 13 the only avenue of air passage.
  • Depressing actuator button 8 releases plunger rod 3 thus allowing plunger 2 to be forced forward by main spring 5.
  • spring 16 pushes rearwardly against stylet plunger block 15 which pulls the attached stylet 11 back out of cannula 13.
  • Cannula 13 continues forward motion as stylet 11 moves back.
  • the associated relationship of motion between cannula 13 and stylet 11 is maintained until the stop collar 20 of plunger 22 contacts the plunger block 2.
  • the cannula 13 is still moving forward, but stylet 11 stops moving backwards and begins to move forward with cannula 13.
  • Both cannula 13 and stylet 11 move forward through the surrounding tissue, cutting off the captured tissue in cannula 13, until the plunger block 2 comes to rest against "O" ring 10, sealing the chamber 21 of the main housing 1.
  • the captured tissue in cannula 13 acts as a seal to the chamber 21 created in the main housing 1 and allows the withdrawal of the needles from the surrounding tissue without accidental loss of the captured tissue.
  • Figs. 6a and 6b The design of prior art cannulas as evidenced by Figs. 6a and 6b include a straight ground cutting • edge 30 which is provided at an angle with respect to the tubular body 32 of the cannula 34.
  • This straight ground cutting edge includes a bevel 36 and defines an oval aperture 38.
  • the oval aperture 38 includes a forwardmost portion 40 and a rearwardmost portion 42. The tissue is severed or cut-off by the rearwardmost portion 42 with the stylet and cannula travelling forwardly together.
  • Figures 7a and 7b depict an improved cannula 50 which has a cutting edge 52 with a straight ground cutting edge portion 54 and a radius ground cutting edge portion 56.
  • the straight ground cutting edge portion 54 in combination with the radius ground cutting edge 56 defines a modified oval aperture 58 which has a forwardmost portion 60 and a rearwardmost portion 62.
  • the rearwardmost portion 62 of the modified oval aperture 58 is substantially V-shaped and includes first and second substantially straight cutting edges 64 and 66 which end abruptly in a point 68.
  • a bevel 70 is provided on the cutting edge 52. As can be seen in Fig.
  • the radius ground cutting edge portion 56 extends below a reference line 70 extending from the straight ground cutting edge portion 54. It can be appreciated that due to the tubular shape of the cannula 50 that as the radius ground cutting edge portion 56 is machined by grinding the cannula 52 about a radius, such as radius 72, that the V-shaped portion is formed with the two straight cutting edges 64, 66.
  • the radius ground cutting edge portion 56 serves to sever the biopsy sample from the surrounding tissues in a highly efficient manner ensuring that the biopsy sample is not left with the mass of surrounding tissue but is extracted with the removal of the biopsy instrument.
  • Figure 8 depicts the stylet 11 projecting through the cannula 50 of the invention preparatory to the biopsy instrument being insert into the mass of tissue from which a tissue biopsy is to be obtained.
  • Figure 2 illustrates a cross-sectional side elevation view of the distal ends of cannula 13 and stylet 11.
  • Stylet 11 is a solid rod with a pointed tip at the distal end. Stylet 11 prevents tissue from entering cannula 13 as it is passed through the surrounding tissue to the point of intended biopsy.
  • FIGS 3a through 3d illustrate the preferred embodiment of the distal needle end of this invention. Four stages of motion are depicted.
  • Figure 3a shows the preferred embodiment of cannula 13 and stylet 11 in the "cocked" position.
  • Figure 3b shows the preferred embodiment of cannula 13 and stylet 11 in the act of being "fired".
  • Figure 3c shows the continuation of motion of cannula 13 with the reversal of motion of the stylet 11.
  • Figure 3d shows the preferred embodiment of cannula 13 and stylet 11 in the act of "cocking" the mechanism and the subsequent expulsion of the tissue sample 15.
  • Figure 4a illustrates the preferred embodiment of the distal needle end with the expulsed tissue sample 15.
  • Figure 4b illustrates the cross-section of tissue 15 obtained from the distal needle end of the • preferred embodiment of this invention.
  • Figure 5a illustrates the dis ⁇ al needle end of the prior art device with the expulsed tissue sample 18.
  • Figure 5b illustrates the cross-section of tissue 18 obtained from the distal needle end of the prior art device.

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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

Un instrument de biopsie automatique comprend une canule (13) montée sur un stylet (11). La canule (13) et le stylet (11) se déplacent l'un par rapport à l'autre de manière à prendre un échantillon de tissu dans la canule. La canule présente un bord tranchant affûté avec courbure (56) de manière à faciliter le sectionnementdu tissu de biopsie.
PCT/US1992/007245 1991-08-29 1992-08-27 Instrument de biopsie avec bord tranchant affute et presentant une courbure WO1993004629A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US75205991A 1991-08-29 1991-08-29
US752,059 1991-08-29

Publications (1)

Publication Number Publication Date
WO1993004629A1 true WO1993004629A1 (fr) 1993-03-18

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2279733A1 (es) * 2006-11-27 2007-08-16 Rudolf Morgenstern Lopez Dispositivo para eliminacion de tejido en operaciones endoscopicas.

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB709714A (en) * 1950-11-17 1954-06-02 Eric Oliver Longley Improvements relating to hypodermic needles
US3788320A (en) * 1972-02-25 1974-01-29 Kendall & Co Spinal needle
US4403617A (en) * 1981-09-08 1983-09-13 Waters Instruments, Inc. Biopsy needle
US4651752A (en) * 1985-03-08 1987-03-24 Fuerst Erwin J Biopsy needle

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB709714A (en) * 1950-11-17 1954-06-02 Eric Oliver Longley Improvements relating to hypodermic needles
US3788320A (en) * 1972-02-25 1974-01-29 Kendall & Co Spinal needle
US4403617A (en) * 1981-09-08 1983-09-13 Waters Instruments, Inc. Biopsy needle
US4651752A (en) * 1985-03-08 1987-03-24 Fuerst Erwin J Biopsy needle

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2279733A1 (es) * 2006-11-27 2007-08-16 Rudolf Morgenstern Lopez Dispositivo para eliminacion de tejido en operaciones endoscopicas.

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