WO2002062230A1

WO2002062230A1 - Biopsy apparatus and method

Info

Publication number: WO2002062230A1
Application number: PCT/US2002/003255
Authority: WO
Inventors: Frank Viola
Original assignee: Tyco Healthcare Group Lp
Priority date: 2001-02-05
Filing date: 2002-02-05
Publication date: 2002-08-15

Abstract

A biopsy apparatus (100) for taking internal tissue samples including an outer hollow outer member (10) and an inner member (20) that contains a cutter (23) . The hollow outer member contains a distal end (12) with a plurality of tissue ports (15). The inner member cuter is positioned along the edge of a cylindrical shaped distal end (22) configured to simultaneously sever and transport a plurality of tissue samples extending through the plurality of tissue ports. The biopsy apparatus includes positioning the apparatus within a tissue portion to be sampled, applying a vacuum, and moving the inner member to simultaneously sever and transport a plurality of tissue samples.

Description

BIOPSY APPARATUS AND METHOD

BACKGROUND

1. Technical Field

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.

2. Background of Related Art

It is often necessary to sample tissue in order to diagnose and treat patients suspected of having cancerous tumors, pre-malignant conditions and other diseases or disorders. Typically, in the case of suspected cancerous tissue, when the physician establishes by means of procedures such as palpation, x-ray or ultrasound imaging that suspicious conditions exist, a biopsy is performed to determine whether the cells are cancerous. 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 FNA biopsy, individual cells or clusters of cells are obtained for cytologic examination and may be prepared such as in a Papanicolaou smear. 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. 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. 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.

The introduction of stereotactic guided percutaneous breast biopsies offered alternatives to open surgical breast biopsy. With time, these guidance systems have become more accurate and easier to use. 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.

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. Generally, such 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 continuing need exists for percutaneous biopsy apparatus and methods which can reliably extract adequate biopsy sample(s) with a single insertion of the biopsy instrument. SUMMARY

A biopsy apparatus is provided that employs a hollow tubular needle with a plurality of tissue ports with a concentric inner member positioned at least partially within the hollow tubular member that severs and transports tissue samples. A vacuum is employed to augment the natural tissue prolapse into the plurality of outer member tissue ports. The biopsy apparatus is capable of simultaneously severing and retrieving a plurality of tissue samples.

A biopsy method is provided wherein a hollow tubular needle with a plurality of tissue ports and a concentric inner member with a cutting edge is at least partially positioned within a portion of tissue to be sampled. A vacuum is applied at the tissue ports to augment tissue prolapse and the inner member is moved within the needle to simultaneously sever and transport a plurality of tissue samples through the hollow tubular needle.

The presently disclosed biopsy apparatus and method, together with attendant advantages, will be best understood by reference to the following detailed description in conjunction with the figures below.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the presently disclosed biopsy apparatus and method are described herein with reference to the drawings, wherein:

FIG. 1 is a perspective view of one embodiment of a multi-port outer member with a distal cutter constructed in accordance with the present disclosure;

FIG. 2 is a longitudinal cross sectional view of the multi-port outer member embodiment of FIG. 1 with a distal cutter; and FIG. 3 is a longitudinal cross sectional view of a second embodiment of the multi- port outer member with a distal cutter constructed in accordance with the present disclosure. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now in specific detail to the drawings in which like referenced numerals identify similar or identical elements throughout the several views and initially to FIG. 1, a preferred configuration of the multi-port outer member with a distal cutter biopsy apparatus 100 (hereinafter referred to as "biopsy apparatus 100") includes a hollow outer member 10 and an inner member 20. Outer member 10 includes a distal end 12 and a proximal end 14 wherein the distal end 12 and proximal end 14 define a longitudinal axis "X." Outer member 10 includes a tubular wall 16 that defines a plurality of tissue ports 15 near distal end 12. Tubular wall 16 also defines a lumen 17 extending distally from proximal end 14 to distal end 12 along the "X" axis and in which inner member 20 is at least partially positioned. A vacuum is employed using lumen 17 as a passageway to assist the drawing of tissue into the plurality of tissue ports 15 for sampling. Inner member 20 can rotate and translate within needle outer member 10 and includes a distal end 22 and a proximal end 24. Distal end 22 is cylindrically shaped and includes a proximally projecting cutting edge 23 formed aroimd its circumferential perimeter. Proximal end 24 extends from distal end 22 along the "X" axis and is manipulated remotely from the proximal end of needle outer member 10. The external circumference of proximal end 24 is suitably sized to provide a passageway for communication of the vacuum to tissue ports 15.

For purposes of clarity, only the details of the working distal ends 12, 22 are illustrated in detail. The proximal ends 14, 24 may be attached to a suitable handle or actuator to facilitate operation of biopsy apparatus 100. For example, biopsy apparatus 100 may include a housing wherein outer member 10 and inner member 20 are housed. The housing may include suitable known driving and actuating mechanisms. In one embodiment 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.

In FIG. 2, biopsy apparatus 100 is shown in a first position with inner member 20 concentric within needle outer member 10 and distal end 22 positioned distal most within needle outer member 10. The plurality of radially aligned tissue ports 15 are defined by wall 16. Tissue ports 15 are positioned proximally to distal end 22 in the distal end 12 of outer member 10. Cutting edge 23 is shown as a straight edge, but it could be suitably serrated or scalloped depending upon the biopsy application. Distal end 22 and cutting edge 23 act in combination to transport a plurality of tissue samples through lumen 17 along the "X" axis. A vacuum source (not shown) is fluidly connected to lumen 17 and the longitudinal passageway through tubular needle outer member 10. The vacuum source augments the natural prolapse of tissue into the plurality of tissue ports 15. In a preferred configuration, needle outer member 10 and inner member 20 are made of a medical grade metal material. In an alternative configuration, cutting edge 23 of inner member 20 may be formed of a suitable medical grade metal and the remainder of distal end 22 and inner member 20 may be formed of a medical grade plastic or composite material.

Referring now to FIG. 3, an alternate embodiment of a biopsy apparatus is shown generally as 200. Biopsy apparatus 200 comprises an outer member 210 including a tubular wall 216 that also defines a lumen 217 extending distally from a proximal end 214 to a distal end 212 along a longitudinal axis "X" and a plurality of tissue ports 215 formed near distal end 212 thereof. Biopsy apparatus 200 further comprises an inner member 220 configured and adapted to rotate and translate within lumen 217 of needle outer member 210 which inner member 220 includes a distal end 222 and a proximal end 224. Distal end 222 of inner member 220 is cylindrically shaped and includes a proximally projecting cutting edge 223 formed around its circumferential perimeter. Proximal end 224 extends from distal end 222 along the "X" axis and is manipulated remotely from the proximal end of needle outer member 210. The external circumference of proximal end 224 is suitably sized to provide a passageway for communication of the vacuum to tissue ports 215. Inner member 220 is configured with a plurality of cups 226 formed near distal end 222 for the retention and transportation of a plurality of severed tissue samples from tissue ports 215. Cups 226 are radially aligned with a respective one of the plurality of tissue ports 215 of outer member 210. Inner member 220 has a tongue 228 for engagement with a mating groove or similarly suitable mechanism that correspondingly aligns the plurality of cups 226 with the plurality of tissue ports 215. In this alternate embodiment, a vacuum is applied through lumen 217 of outer member 210 to the plurality of tissue ports 215 and inner member 220 is translated proximally along the "X" axis to simultaneously sever and transport a plurality of tissue samples in the plurality of cups 226.

Referring once again to FIGS. 1 and 2, in operation, 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. In either arrangement, 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 pierces the patient's body while in a first position, wherein distal end 22 of inner member 20 is positioned within distal end 12 of outer member 10. When needle outer member 10 is positioned within the patient adjacent the tissue to be sampled a vacuum is drawn through opening 17 to augment the natural tissue prolapse into the plurality of tissue ports 15. Inner member 20 is then withdrawn proximally through outer member 10 by translating or rotating and translating to sever multiple tissue samples simultaneously. Meanwhile, in a second position, inner member 20 transports the plurality of tissue samples through needle outer member 10 for recovery. If so desired, inner member 20 can be reinserted into distal end 12 of needle outer member 10 and needle outer member 10 rotated or repositioned longitudinally along the "X" axis for removing additional tissue samples.

Although the illustrative embodiments of the present disclosure have been described herein with reference to the accompanying drawings, it is to be understood that the disclosure is not limited to those precise embodiments, and that various other changes and modifications may be affected therein by one skilled in the art without departing from the scope or spirit of the disclosure. All such changes and modifications are intended to be included within the scope of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A biopsy apparatus comprising: a hollow needle having a distal end and a proximal end defining a longitudinal axis, the distal end having a plurality of tissue ports formed therein, the hollow needle further defining a lumen configured and adapted to apply a vacuum through the hollow needle to the plurality of tissue ports; and an inner member having a distal end and a proximal end, the distal end of the inner member being provided with a cutting edge, the inner member movably positionable at least partially within the hollow needle along the longitudinal axis to simultaneously sever and transport a plurality of tissue samples through the hollow needle.

2. A biopsy apparatus according to claim 1, wherein the inner member includes an elongated body portion having a head mounted to a distal end thereof.

3. A biopsy apparatus according to claim 2, wherein the inner member is configured and adapted to be slidingly received within the lumen of the hollow needle.

4. A biopsy apparatus according to claim 3, wherein the cutting edge of the head is formed around a circumferential perimeter thereof and projects proximally thereto.

5. A biopsy apparatus according to claim 4, wherein the head is sized to permit the passage of a fluid between the circumferential perimeter thereof and an inner surface of the hollow needle.

6. A biopsy apparatus according to claim 5, wherein the head includes a plurality of proximally oriented cups, wherein a respective one of the plurality of cups is aligned with a respective one of the plurality of tissue ports.

7. A biopsy apparatus according to claim 6, wherein the head further includes at least one tongue projecting radially outward, the tongue being configured and adapted to engage a corresponding slot formed in the inner surface of the hollow needle, the tongue and slot cooperating to radially align the head within the hollow needle.

8. A method of obtaining a plurality of tissue samples from a patient with a biopsy apparatus comprising the steps of: positioning a biopsy apparatus in the patient at least partially within a portion of tissue to be sampled, wherein the biopsy apparatus includes a hollow outer member with a distal end containing a plurality of tissue ports and a needle tip; and an inner member at least partially positioned within the outer member containing a cutting edge formed around a circumferential perimeter thereof; and applying a vacuum to the hollow outer member; and repositioning the inner member to simultaneously sever and transport a plurality of tissue samples through the hollow outer member.