Biopsy Device

Abstract

A biopsy device, primarily for cervical biopsy, comprising a generally arrowhead-shaped tool substantially V-shaped in cross section and having outer longitudinal knife edges intersecting at the sharp tip of the device. In use, the device is inserted into the tissue from which the specimen is to be taken. To separate the specimen from the adjacent tissue, a scalpel is run forwardly along longitudinal converging guide means-- a groove or rib-- provided on each inside face of the device just below each knife edge. The two converging guide grooves or ribs terminate at a central hole, which functions as a stop to limit forward movement of the scalpel. The separated specimen is thus held in the receptacle provided by the V-cross section tool, in which it is carried for removal from the body.

Description

BACKGROUND OF THE INVENTION

This invention relates to taking biopsy specimens, particularly of the uterine cervical area. In testing for carcinoma of the uterus, the critical area is the entrance to the cervix--the squamous columnar junction. It is here that 90 percent of uterine cancer is present.

The exposed tissue at this area, called the "epithelium," is the critical layer of tissue which it is desired to test for cancer, together with some of the underlying tissue called the "stroma" which is examined for depth of cancer spread, if any.

Presently used techniques have various disadvantages. For example, in one known technique, a punch is employed. The punch removes a complete circumferential ring of tissue from the cervical canal, and cuts in from the canal itself through the epithelium. Taking a complete ring of tissue is undesirable. One of the serious after effects can be closure of the cervical canal as a result of scar tissue formation. Cutting through the epithelium lined canal is undesirable as the biopsy instrument preferably should not touch the surface of the tissue to be examined.

Another technique involves using an ordinary surgeon's knife or scalpel to cut off a segment of the cervix at the canal entrance. However, in this technique, the surgeon is unable to control the depth of the cut, and it is extremely difficult to retrieve the cut sample.

Other techniques have one or more of the various foregoing disadvantages.

SUMMARY OF THE INVENTION

The biopsy device of the present invention comprises a generally pointed instrument having converging side knife edges. The device is shaped to provide a recess or receptacle for defining and holding the biopsy sample. In the preferred form of the invention, the recess or receptacle is provided by virtue of the instrument being substantially V-shaped in transverse cross section.

In use, the device is inserted into the tissue area from which a biopsy specimen is to be taken. For example, for a cervical biopsy, it is inserted into the cervical wall just below the epithelial surface to be sampled. Then, to cut the specimen free, a scalpel is run forwardly along a guide groove or rib provided on each of the two opposed inside converging faces of the instrument just below and parallel to the adjacent knife edges. The forward cutting movement of the scalpel is automatically stopped by a hole at which the two converging guide grooves or ribs meet.

The specimen has now been cut free, and is held in the recess of the instrument by which it is carried outside the body for examination.

It is therefore the primary object of the present invention to provide a novel biopsy device.

It is a further object to provide a biopsy device which will not touch the surface of the tissue to be sampled.

It is a further object to provide a biopsy device which will avoid taking a completely annular specimen, but will rather take multiple selective transverse specimens.

It is a further object to provide a biopsy device the use of which will promote rapid healing of the area from which the specimen is taken.

It is a further object to provide a biopsy device which provides accurate control of the specimen taken even though the surgeon cannot easily see the biopsy area.

The above and other objects, advantages, and features of the invention will become apparent to those skilled in the art from the following detailed description of preferred embodiments of the invention when read in conjunction with the accompanying drawing.

DESCRIPTION OF THE FIGURES

FIG. 1 is a top plan view of the novel biopsy device of the invention.

FIG. 2 is a elevational view looking in a longitudinal direction from the rear toward the front of the device.

FIG. 3 is a longitudinal sectional view taken on line 3-3 of FIG. 1.

FIG. 4 is a partial transverse sectional view taken on line 4-4 of FIG. 3, showing one of the grooves for guiding a scalpel to cut off one side of the biopsy sample.

FIG. 5 is a view similar to FIG. 4 of a modified form of the invention in which ribs are employed instead of grooves.

FIG. 6 is a side elevational view of the uterine-cervical area of the body, showing the technique of using the biopsy device of the invention.

FIG. 7 is an enlarged front view of FIG. 6, further showing a scalpel cutting through one side of the biopsy sample.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to the drawing, the reference numeral 2 designates a handle to which the biopsy device 4 of the present invention is attached. Handle 2 may be of any suitable size and shape. The device 4 may be permanently or removably attached to the handle.

The biopsy device 4 itself, as best seen in FIGS. 1 and 2, comprises two thin-walled flat or planar sections 6 and 8 which are disposed at an angle to each other and intersect along a central longitudinal line 10. Preferably the dihedral angle between sections 6 and 8 is approximately 90 degrees, as shown in FIG. 2.

The respective outer side edges 12 and 14 of sections 6 and 8 are each sharpened to a fine cutting knife edge. Knife edges 12 and 14 converge forwardly and downwardly to meet at and form the sharp tip 16 of the device.

It will be seen from the foregoing description that the biopsy device 4 is generally like an arrowhead in overall shape. Further, the angularly disposed sections 6 and 8 making up the body of the device provide it in the form of a recess or receptacle which is generally wedge-shaped. As will be described shortly, this receptacle aspect of the invention greatly simplifies retention of the cut biopsy sample and its removal from the body.

Guide means are provided to control movement of a scalpel along predetermined paths to sever the biopsy specimen from the adjacent tissue. Such guide means comprises guide grooves 18 and 20 provided on the respective opposed inside faces of sections 6 and 8. Grooves 18 and 20 are parallel with and closely adjacent to the related knife edges 12 and 14 respectively. The converging grooves terminate at a small hole 22 formed on centerline 10 adjacent tip 16. Hole 22 automatically stops the scalpel being moved forwardly along groove 18 or 20.

As shown in FIG. 5, raised ribs 24 may be employed as the scalpel guide means instead of the depressed grooves 18, 20. Here, the scalpel is held pressed downwardly and against the rib so as to be guided thereby in its forward movement.

The device 2 is made of any suitable material, e.g., stainless steel. It can be fabricated by any suitable techniques. For example, it can be formed as an integral device by first stamping a blank of the appropriate shape, which is then bent and otherwise worked, and sharpened, to produce the final device.

A typical use of the biopsy device of the invention for taking a cervical epithelial specimen will now be described. Referring to FIGS. 6 and 7, numeral 26 designates the cervix and 28 the cervical canal. The device is held by handle 4 and inserted tip first into the cervical area just underlying the section of epithelial cervical canal tissue to be sampled. The device is inserted to the desired depth, the penetration being facilitated by the sharp tip 16 and the sharp knife edges 12, 14. Then, the surgeon places the cutting edge of a scalpel 30 (FIG. 7) on the exposed (nonpenetrating) portion of groove 18 or 20 and runs the scalpel forwardly along the groove until the scalpel is automatically stopped by reaching hole 22. This stopping is further signalled to the surgeon by virtue of the different sensation that he feels through his fingers when the scalpel hits the hole. This step has cleanly severed one side of the biopsy specimen from the adjacent tissue without jagged edges. The surgeon then repeats the process using the other groove, whereby the specimen has now been completely separated from the adjoining tissue, and is held in the receptacle provided by the V cross section of the biopsy device.

It should be noted that the cutting path, and its length and depth, of the scalpel 30 to sever the sides of the specimen are accurately guided and controlled by the guide grooves 18, 20 (or ribs 24), and the stop hole 22, even though the surgeon is cutting essentially blind into the tissue.

The device 2 carrying the specimen within it is now removed from the body and the specimen then removed for examination.

Usually, four, but possibly more, specimens will be taken at spaced locations around the cervical canal. This provides a good sampling while leaving bridges of tissue intact to facilitate healing without the danger of stricture or closing of the canal by scar tissue formation as would be likely if a completely annular sample or set of tissue samples were taken.

The fact that the tissue specimen taken by the present device is wedge-shaped is advantageous for several reasons. For one thing, this shape enables the surgeon to determine by mere visual inspection of the specimen its orientation, i.e., which is the more significant epithelial face and which is the less significant, underlying stroma. The large broadest surface of the specimen will of course be the exposed epithelium of the cervical canal, while the narrow tapering portion will be the stroma. Further, the wedge-shaped inwardly tapering crevice left by the removal of the specimen helps facilitate healing.

While intended primarily for cervical biopsy, the principles of the present invention can also advantageously be used for biopsy of other portions of the body, e.g., the surface of the ovaries, the uterus, liver, kidney, lung, etc.

While there have been shown and described two preferred embodiments of the invention, it will be understood and apparent to those skilled in the art that numerous variations and modifications, in form and application, can be made without departing from the spirit and scope of the invention and its features. Accordingly, it is intended that the foregoing disclosure be exemplary only, and not in any way limitative of the following claims.

Claims

I claim:

1. In a biopsy instrument, a generally pointed device having converging cutting knife edges, means defining a receptacle between said knife edges comprising two substantially flat planar portions disposed at an angle to each other intersecting along a longitudinally extending line to provide a tapered, substantially V-shape in transverse cross section, said converging cutting knife edges being respectively positioned at the outermost longitudinal edges of the planar portions, and means disposed between the knife edges for guiding a cutting tool.

2. The combination according to claim 1 wherein said knife edges are substantially linear and meet at the point of said device to from a sharp tip.

3. The combination according to claim 2 wherein the knife edges and said longitudinally extending line meet at said tip.

4. The combination according to claim 3 wherein said angle is substantially a right angle.

5. The combination according to claim 1 including means for stopping movement of a cutting tool.

6. The combination according to claim 5 wherein said guide means comprises elongated groove means provided on said planar portions.

7. The combination according to claim 6 wherein said groove means comprises converging grooves, one disposed adjacent each knife edge.

8. The combination according to claim 7 wherein said stopping means comprises means defining a hole in said device, said converging grooves terminating at said hole.

9. The combination according to claim 6 wherein said stopping means comprises means defining a hole in said device.

10. The combination according to claim 5 wherein said guide means comprises elongated rib means provided on said planar portions.

11. The combination according to claim 10 wherein said rib means comprises converging ribs, one disposed adjacent each knife edge.

12. The combination according to claim 11 wherein said stopping means comprises means defining a hole in said device, said converging ribs terminating at said hole.

13. The combination according to claim 10 wherein said stopping means comprises means defining a hole in said device.

14. The combination according to claim 5 wherein said stopping means comprises means defining a hole in said device.