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WO1993020753A1 - Aiguilles de biopsie - Google Patents

Aiguilles de biopsie Download PDF

Info

Publication number
WO1993020753A1
WO1993020753A1 PCT/US1992/003252 US9203252W WO9320753A1 WO 1993020753 A1 WO1993020753 A1 WO 1993020753A1 US 9203252 W US9203252 W US 9203252W WO 9320753 A1 WO9320753 A1 WO 9320753A1
Authority
WO
WIPO (PCT)
Prior art keywords
stylet
cannula
degrees
point
shaped edge
Prior art date
Application number
PCT/US1992/003252
Other languages
English (en)
Inventor
Hakan Jorulf
Original Assignee
Biomni Medical Systems, Inc.
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 Biomni Medical Systems, Inc. filed Critical Biomni Medical Systems, Inc.
Priority to PCT/US1992/003252 priority Critical patent/WO1993020753A1/fr
Priority to AU23156/92A priority patent/AU2315692A/en
Publication of WO1993020753A1 publication Critical patent/WO1993020753A1/fr

Links

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

Definitions

  • This invention relates to improvements in biopsy needles used in biopsy procedures.
  • the method most commonly followed for obtaining tissue samples has been to use a needle which is formed of an inner solid rod which has a sampling notch in the distal end thereof, in conjunction with a hollow outer cannula which slides thereover and cuts tissue which has been located in the sampling notch of the inner rod.
  • the inner rod except for its pointed distal end, is located within the cannula when the device is inserted into the tissue to be sampled.
  • the outer cannula is then held stationary while the inner rod is inserted deeper into the tissue. While in this position, tissue moves into the sampling notch of the inner rod just adjacent the pointed distal tip thereof.
  • the inner rod is then held stationary while the outer cannula is slid thereover.
  • the biopsy gun restricts needle movement to specific directions and also carries springs and separate piston mechanisms therein which drive the rod and cannula through their sampling motions in a rapid and predictable manner.
  • This • technique is exemplified in U. S. Patent No. 4,699,154. Even though these automated biopsy guns are an improvement over manually actuated needles, the basic design of the needles themselves has remained the same.
  • the cannula of the biopsy needles must be relatively thick walled to provide strength and resistance to crushing and bending during insertion of the needles into the structure being biopsied.
  • the minimal wall thickness of the cannula of prior art needles has ranged from 0.15 mm for a 21 gauge needle to 0.20 mm and more for a 14 gauge needle.
  • the forceful introduction of a needle into the tissue area generally causes a certain amount of damage to the tissue in the immediate surroundings of the target area.
  • the relative wall thickness of the cannulas used in prior art needles forms a toroidal interface on the leading side edge of the stylet as the biopsy needle is injected into the tissue being biopsied.
  • This toroidal interface in the case of prior art needles is of sufficient size that it causes damage of the outer (peripheral) part of the core sample. For example, it often causes damage of peripheral glomeruli in. cas of renal biopsy.
  • the toroidal interface of the prior art needles can damage surrounding tissue as the needle is being inserted through areas adjacent to the site of the biopsy as well as when the needle is inserted into the area of the tissue which is to be biopsied.
  • the toroidal interface can cause transfer of normal tissue from adjacent areas of the site of the biopsy to the area in which the biopsy sample is being taken. This complicates the procedure inasmuch as the sample tissue taken may be partly or predominantly normal tissue that has been transferred to the biopsy site by the action of the toroidal interface formed by the distal end of the cannula.
  • the increased bulk size of the needle due to the relatively large wall thickness of the cannula increases the complications that can accrue during and after the biopsy procedure due to damage caused to the surrounding tissue during the procedure. It is well known that complications do occur in conjunction with prior art biopsy procedures.
  • Surrounding sensitive structures can be damaged by the sharp insertion point of the stylet as well as by the toroidal interference surface formed by the distal end of the cannula.
  • Such sensitive structure that can be damaged includes blood vessels, nerves, ducts or channels and sensitive membranes. Damage to blood vessels results in undesirable bleeding and loss of blood. Large blood collection can result in severe organ damage. Nerves can be damaged with loss of their function. Ducts and channels can be damaged with leakage of fluid into other body compartments.
  • Sensitive membranes can be damaged leading to severe pain. Further complicating the matter with respect to the use of prior art biopsy needles, the pointed end of the stylet is relatively large and no attention has been made to develop new and advanced designs for this part of the needle.
  • the tip of the stylet that extends beyond the distal end of the cannula has a length of between about 5 mm and 7 mm. This part of the stylet of course passes into the tissue and often bypasses the structure to be biopsied. This undue extension in many cases can cause undesirable damage to other tissue and organs that are otherwise normal and should not be damaged. Undesired damage can occur to normal, sensitive structures, and disease can be spread into such normal areas beyond the pathological target area. It also carries an additional risk of spreading diseased tissue material into normal tissues.
  • a particular object of the present invention is to provide a biopsy needle of acceptable outer diameter that utilizes an ultra thin walled cannula which allows an increase in the relative amount of tissue to be retrieved in comparison to conventional biopsy needles in the prior art.
  • Another objective of the present invention is to develop a new, rather inexpensive biopsy needle having an ultra thin walled cannula whose distal end is formed as a slanting, pointed end which unexpectedly acts as a razor type edge during severing of tissue and thus markedly improves the quality of the tissue sample that is obtained.
  • a further object of the present invention is to provide a new biopsy needle having an ultra thin walled cannula that causes less crushing or damage to the peripheral parts of the core tissue sample and in addition results in a significantly smaller outer diameter for the biopsy needle to thereby further reduce risks of complications developing during or following the biopsy procedure.
  • a still further object of the present invention is to provide a new biopsy needle having a novel combination of design features including an ultra thin walled cannula and specially designed, pointed distal end of the stylet which results in substantial reduction in complication rates from biopsy procedures as compared to such complication rates experienced with conventional prior art biopsy needles.
  • Tissue biopsy from human organs and structures is used for a variety of purposes including diagnosis of disease following the course of treatment for a disease, and otherwise monitoring the response to various drugs or substances which will influence the health.
  • Tissue retrieved can be analyzed in many different ways including for instance histology, cytology, electron microscopy, histochemistry and immunoanalysis.
  • Such retrieval of tissue from the interior of the body is commonly performed by introducing a needle into the body structures thereby giving access to the particular structure to be biopsied. In the vast majority of cases, the needle has to pass through normal structures before reaching the target.
  • Tissue retrieval can be performed in various quantities. In general, smaller tissue samples will allow for cytological analysis, while histological study needs a larger sample for preparation and investigation. It is well known that complications can occur in conjunction with a biopsy procedure. Surrounding sensitive structures can be damaged by the needle. Damaging blood vessels can cause severe bleeding with loss of blood or damage of an organ due to large blood collection. Damaged nerves can result in loss of function. Damaged ducts or channels result in leakage of fluid into other body compartments. Damage to sensitive membranes can cause severe pain.
  • pathological tissues often include neoplasm (tumor) which has increased blood supply.
  • neovascularity tumor vessels
  • neovascularity tumor vessels
  • blood vessels carrying the blood to the neoplasm.
  • spread of disease can occur from the biopsy procedure when the needle passes through the diseased area into healthy, normal structures.
  • Pathological structure can be spread forward as the needle is being inserted into the subject or backward when the needle is being retracted. In either case pieces of pathological tissue can be spread and left along the track of the needle.
  • the rate of complication varies according to what organ is being biopsied and is related to the size of the introcluded needle.
  • the incidence of death in conjunction of biopsy varies but has been reported high as 0.3% in certain procedures. It has unexpectedly been found that a novel combination of improved features for biopsy needles can be provided that will significantly reduce complication rate.
  • the larger the outer diameter of the needle, and the longer the pointed end of the stylet extending from the cannula the larger is the risk for complication to occur.
  • the size (outer diameter) of biopsy needles is, of course, maintained as small as possible to minimize damage and complications.
  • the cannula has to have a certain inner diameter to allow for sufficient material being collected and contained in the needle.
  • an ultra thin walled cannula can be employed in a biopsy needle.
  • the ultra thin walled cannula allows a larger sample to be taken without increasing the outer diameter of the cannula.
  • a cannula having an ultra thin wall can be used in biopsy needles, and in fact such an ultra thin walled cannula results in significant additional unexpected improvements in the operation and performance of the biopsy needle. Further, when the ultra thin walled cannula is used in combination with improvements in the tip of the stylet of the biopsy needle, the occurrence of undesirable complications during and following the biopsy procedure can be significantly reduced.
  • FIG. 1 is a longitudinal, central cross section through an improved biopsy needle in accordance with the present invention
  • FIG. 2 is a pictorial end view of the cannula of the needle of Fig. 1 showing the sharpened, distal end of the cannula;
  • FIG. 3 is a pictorial end view of the stylet of the needle of Fig. 1 showing the sharpened, distal end of the stylet;
  • FIG. 4 is a longitudinal, central cross section similar to that of Fig. 1 but showing a modified embodiment of the needle unit in accordance with the present invention.
  • the improved biopsy needle 10 of the present invention comprises an elongate solid stylet 12 and an elongate cannula 14 that slides in telescopic fashion over the stylet 12.
  • a notch 16 is formed in the stylet 12 near the distal end of the stylet 12.
  • the cannula 14 has an outside diameter of between about 2.1 mm and 0.8 mm and corresponding wall thickness of between about 0.1 mm and 0.06 mm, respectively.
  • the distal end of the cannula 14 has a slanted point formed by finely grinding the distal end to form an essentially planar, oval shaped edge 20 (Fig. 2) that lies on an essentially flat plane which slants backward toward the cannula at an angle of between about 25 degrees and 35 degrees with respect to the elongate axis of the cannula 14.
  • the slanted, pointed end 20 of the cannula 14 slants at an angle of between about 27 degrees and 31 degrees, and in a most preferred embodiment, the end 20 of the cannula 14 slants at an angle of about 29 degrees.
  • the elongate, inner stylet 12 is received for longitudinal sliding movement within the cannula 14.
  • the stylet 12 has an outside diameter that is no more than about 0.1 mm less than the minimum inside dimension of the cannula 14.
  • a slanted point is formed at the distal end of the stylet 12 by finely grinding the distal end of the stylet 12 to form an essentially planar, oval shaped edge 22 (Fig. 3) that lies on an essentially flat plane which slants backwardly toward the stylet 12 at an angle of between about 25 degrees and 35 degrees with respect to the elongate axis of the stylet 12.
  • the slanted, pointed end 22 of the stylet 12 slants at an angle of between about 27 degrees and 31 degrees, and in a most preferred embodiment, the end 22 of the stylet 12 slants at an angle of about 29 degrees.'
  • an elongate sample receiving notch 30 is formed inwardly from one side of the stylet 12.
  • the notch 30 is of any desirable length up[ to about 25 mm and has a depth of up to about 2/3 of the diameter of the stylet 12.
  • Such notches 30 are well known and understood in the art of biopsy needles, and the dimensions of the notch 30 are given for illustrative purposes only. These dimensions are not per se critical and thus a broad range of dimensions has been recited.
  • the distal most point of the notch 30 is spaced in a longitudinal dimension along the stylet 12 from the innermost point of the oval sharpened edge 22 of the distal end of the stylet 12 by a distance of at least about 1 mm, preferably between about 1.25 mm and 1.75 mm, and most preferably between about 1.3 mm and 1.5 mm.
  • the biopsy needles of the present invention can in fact have a smaller outer diameter than previous prior art needles and still achieve a core diameter as large or larger than possible using prior art biopsy needles. It has been further unexpectedly found that by a simple procedure in which the distal end of the ultra thin walled cannula is finely ground to an essentially flat, planar, oval edge as specified above, the oval edge forms a razor like cutting edge.
  • the razor like cutting edge cuts the tissue sample in a clean razor like cut without crushing or otherwise damaging the cut surface of the tissue sample.
  • the fine grinding of the distal end to form the oval, slanting edge is generally sufficient to produce a razor sharp edge.
  • This edge can, if desired, be further honed to a very sharp, razor edge.
  • the distal end of the ultra thin walled cannula forms a very thin edge that does not disrupt and harm tissue as the biopsy needle is being inserted into the tissue and as the biopsy sample is being taken.
  • the very thin interference edge of the distal end of the ultra thin walled cannula is significantly less pervasive than the edge formed at the distal ends of the relatively thick walled cannulas used in prior art needles.
  • the relatively thick interference edge of the thick walled cannulas of prior art biopsy needles crushes and damages tissue as the biopsy needle is inserted and pushed through the tissue.
  • the interference edge of the relatively thick walled cannulas may transport portions of severed tissue along the outer surface of the needle as the needle is pushed through surrounding tissue. Normal tissue from a surrounding area can in fact be transported to the target area for the biopsy, and the normal tissue can be included in the tissue sample extracted during the biopsy procedure. It has been unexpectedly found that by using ultra thin walled cannulas as specified and claimed herein, little and if any only insignificant damage is done to surrounding tissue as the biopsy needle is pushed through the surrounding tissue.
  • the solid tip of the stylet that extends from the distal end of the cannula as the needle is being inserted into and pushed through tissue is relatively long, e.g., 5 mm to 7 mm, and no special attention has been paid to improving the design of this part of the stylet.
  • this solid tip is often long enough to by-pass through the structure being biopsied. The relatively large tip can cause unnecessary damage to surrounding, normal tissue and sensitive structures. The unnecessary extension of the solid tip of the stylet beyond the structure to be biopsied can spread disease from the structure that is being biopsied to normal tissue beyond the pathological target area.
  • the length that the tip of the stylet 12 extends from the cannula 14 during insertion of the biopsy needle 10 is minimized. It has been found that the exposed tip of the biopsy needle of the present invention allows insertion of the needle through tissue as adequately as the longer tips of prior art needles. Further, the needles of the present invention have been surprisingly capable of causing much less damage to surrounding tissue than incurred with prior art biopsy needles.
  • FIG. 4 A slightly modified embodiment of a biopsy needle in accordance with the present invention is shown in Fig. 4.
  • the stylet 12 is formed such that no more than about 1.5 mm of the stylet from the innermost point on the slanted end projects outwardly from the distal tip end of the cannula 14.
  • Other criteria for the cannula 14 and stylet 12 are the same as discussed previously with respect to the embodiment shown in Figs. 1-3.
  • the needle 10 is inserted through surrounding tissue to the target area, with the tip end of the stylet 12 and the distal end of the cannula 14 being located within the target area.
  • the cannula 14 is then slid forwardly and outwardly over the end of the stylet 12.
  • sample tissue is cut and drawn into the hollow distal end of the cannula 14.
  • the slight vacuum formed either by keeping the stylet at stand still or by the withdrawing of the stylet 12 within the cannula 14 aids in drawing severed tissue into the hollow distal end of the cannula 14.
  • external means can be provided to draw additional vacuum in the cannula 14 through a small channel (not shown in the drawings) formed in the stylet 12.

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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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention se rapporte à des aiguilles creuses de biopsie (10) conçues pour être utilisées dans des biopsies tissulaires et qui comportent une cannule allongée (14) ayant une extrémité distale qui possède une pointe biseautée formée par un bord (20) terminal plat biseauté vers l'arrière en direction de la cannule (14). Un stylet (12) interne, allongé, est reçu et glissé longitudinalement à l'intérieur de la cannule (14). L'extrémité distale du stylet (12) possède une pointe biseautée formée par une extrémité plate (22) biseautée vers l'arrière en direction du stylet. Une encoche (30) recevant l'échantillon est formée vers l'intérieur à partir d'une face du stylet (12).
PCT/US1992/003252 1992-04-21 1992-04-21 Aiguilles de biopsie WO1993020753A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/US1992/003252 WO1993020753A1 (fr) 1992-04-21 1992-04-21 Aiguilles de biopsie
AU23156/92A AU2315692A (en) 1992-04-21 1992-04-21 Biopsy needles

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1992/003252 WO1993020753A1 (fr) 1992-04-21 1992-04-21 Aiguilles de biopsie

Publications (1)

Publication Number Publication Date
WO1993020753A1 true WO1993020753A1 (fr) 1993-10-28

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ID=22230993

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1992/003252 WO1993020753A1 (fr) 1992-04-21 1992-04-21 Aiguilles de biopsie

Country Status (2)

Country Link
AU (1) AU2315692A (fr)
WO (1) WO1993020753A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0841874A4 (fr) * 1994-10-31 1998-05-20
WO2015055490A1 (fr) * 2013-10-16 2015-04-23 Apriomed Ab Dispositif de biopsie

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4403617A (en) * 1981-09-08 1983-09-13 Waters Instruments, Inc. Biopsy needle
US4708147A (en) * 1985-02-25 1987-11-24 Haaga John R Universal biopsy needle
US4735215A (en) * 1987-01-05 1988-04-05 Goto David S Soft tissue biopsy instrument
US5090419A (en) * 1990-08-23 1992-02-25 Aubrey Palestrant Apparatus for acquiring soft tissue biopsy specimens

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4403617A (en) * 1981-09-08 1983-09-13 Waters Instruments, Inc. Biopsy needle
US4708147A (en) * 1985-02-25 1987-11-24 Haaga John R Universal biopsy needle
US4735215A (en) * 1987-01-05 1988-04-05 Goto David S Soft tissue biopsy instrument
US5090419A (en) * 1990-08-23 1992-02-25 Aubrey Palestrant Apparatus for acquiring soft tissue biopsy specimens

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0841874A4 (fr) * 1994-10-31 1998-05-20
US5989196A (en) * 1994-10-31 1999-11-23 Boston Scientific Corporation Biopsy needle
WO2015055490A1 (fr) * 2013-10-16 2015-04-23 Apriomed Ab Dispositif de biopsie
CN105636522A (zh) * 2013-10-16 2016-06-01 阿普锐欧医学股份公司 活检设备
US20160249890A1 (en) * 2013-10-16 2016-09-01 Apriomed Ab Biopsy device
JP2016537049A (ja) * 2013-10-16 2016-12-01 アプリオメッド アーベーＡｐｒｉｏｍｅｄ Ａｂ 生検デバイス
US10959709B2 (en) 2013-10-16 2021-03-30 Apriomed Ab Biopsy device

Also Published As

Publication number Publication date
AU2315692A (en) 1993-11-18

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