Biopsy Technique And Biopsy Device

Abstract

A biopsy needle device and method of using the same includes an elongate needle having a tapered distal end portion which terminates in a distal cutting edge. An elongate sleeve member is inserted into the needle and corresponds in shape and length to the needle. An elongate stylet is positioned interiorly of the telescopically disposed needle and sleeve member and projects from the needle to close the distal end thereof so that the needle assembly may penetrate exterior tissue when a specimen is to be taken from a deeply located organ or tissue of a patient. The stylet is first removed and the biopsy specimen is collected in the sleeve member which is then removed from the needle while the needle is allowed to remain in place so that a heat transfer means such as a microcauter or a cryoprobe may be introduced into the needle. The distal end of the microcauter or cryoprobe projects into the biopsy track, and the needle and heat transfer means are removed as a unit whereby cauterization or cooling of the biopsy track occurs and intro-organ bleeding is prevented. The expanding or tapered distal end portions of the sleeve and biopsy needle permit the specimen to be collected in the sleeve with little if any damage to the specimen.

Description

SUMMARY OF THE INVENTION

Although there are many kinds specialized biopsy instruments used for obtaining biopsy specimens from various organs, it has been found that such instruments are quite often unsatisfactory in obtaining biopsy specimens from organs such as the spleen, thyroid or other organs which tend to bleed profusely if a biopsy specimen is taken. Therefore when biopsy specimens are taken from the spleen, thyroid or similar organ, it is necessary to resort to a surgical procedure in order to manage and prevent bleeding after removal of the biopsy specimen.

It is therefore a general object of this invention to provide a novel biopsy technique and device for obtaining an effective biopsy specimen from an organ such as a spleen or thyroid which tends to bleed profusely but in a manner in which bleeding is minimized if not substantially precluded.

The present biopsy technique and device involves the insertion of a biopsy needle into the tissue from which the specimen is to be taken, the needle having a sleeve member and stylet therein, the stylet being removed and the biopsy being collected in the sleeve which is also thereafter removed. A heat transfer means such as a microcauter or a cryoprobe is inserted through the needle to project from the distal end thereof, and which serves to cauterize the biopsy track as the needle and heat transfer means are removed as a unit.

Through the use of this technique and device, biopsy specimens may be obtained from organs such as the spleen or thyroid without requiring surgical procedures which is normally required when obtaining such biopsy specimens.

BRIEF DESCRIPTION OF THE FIGURES OF THE DRAWING

FIG. 1 is an exploded perspective view illustrating the biopsy needle device including the biopsy needle, sleeve member and stylet,

FIG. 2 is a cross-sectional view illustrating the microcauter projecting through the needle,

FIG. 3 is a side-elevational view of a cryoprobe which may be used as an alternative to the microcauter and,

FIG. 4 is a fragmentary perspective view of a modified form of the cutting edge of a biopsy needle.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings and most specifically to FIG. 1, it will be seen that one embodiment of the novel biopsy needle device, designated generally by the reference numeral 10 is there shown. The biopsy needle device 10 is comprised of an elongate biopsy needle 11 having an elongate cylindrical body 12 which terminates in a uniformly distal tapered end portion 13. Opposite ends of the needle 11 are open and it will be noted that a cutting edge 14 is defined by the distal end. The biopsy needle 11 is preferably formed of a suitable metallic material and the lumen 12a of the cylindrical body portion communicates smoothly with the lumen or interior 13a of the tapered distal end portion 13. In the embodiment shown, the cutting edge defined by the distal end is bevelled or obliquely disposed with respect to the longitudinal axis of the needle 11.

The biopsy needle 11 is also provided with a pair of outwardly projecting oppositely disposed finger grip elements 15 and terminates in an enlarged cylindrical proximal end portion 16. It will be noted that the enlarged cylindrical proximal end portion 16 has a distal end wall 17 which in the embodiment shown engages the finger grip elements 15. This proximal end portion 16 also has a notch 18 therein which extends in a general longitudinal direction and which terminates in an offset portion.

The biopsy needle device also includes an elongate sleeve member 19 which serves as a tissue-collecting medium and which is adapted to be positioned interiorly of the needle 11. The sleeve member 19 includes an elongate cylindrical body 20 which terminates in a uniformly tapered distal end portion 21. Opposite ends of this sleeve member 19 are also open and it will be noted that the distal end 22 also defines a cutting edge which is bevelled or obliquely disposed with respect to the longitudinal axis of the sleeve member. The cylindrical body 20 of the sleeve member 19 also communicates smoothly with the lumen of the tapered distal end portion 21 in the manner of the needle 11.

The sleeve member also has an enlarged cylindrical proximal end portion 23 which is provided with a radially projecting locking pin 24. The locking pin 24 is adapted to engage in the notch 18 to releasably interlock the sleeve member 19 within the needle 11. The proximal end portion 23 also has a generally axially extending notch 25 therein which also terminates in an offset portion. It will be noted that the pin 24 and notch 25 are spaced axially from each other.

The sleeve member 19 is also preferably formed of a suitable metallic material and is adapted to receive therein an elongate metallic stylet 26 which in the embodiment shown is preferably of cylindrical configuration and terminates in a bevelled or obliquely disposed distal end 27. The stylet is also provided with an enlarged cylindrical proximal end portion 28 and terminates in a finger grip portion or handle 29. A locking pin 30 is affixed to the proximal end portion 28 and projects radially therefrom. This locking pin is adapted to engage in the notch 25 of the sleeve member 19. It is pointed out that the sleeve member will have its distal end 22 disposed in substantially aligned relation with the distal end 14 of the needle 11. However, the stylet 26 when interlocked with the sleeve 19 will project approximately one millimeter beyond the end of the biopsy needle 12 and this serves to obstruct the distal end of the assembled biopsy needle device.

Heat transfer means is also provided so that the temperature of the biopsy track may be radically changed to prevent intraorgan bleeding after the removal of the biopsy specimen.

Referring now to FIG. 2, it will be seen that such a heat transfer means may include a microcauter 31 which includes an elongate hollow probe 32 having a closed distal end or tip 33 in which is disposed a resistance element. A pair of electrical conductors 34 extend through the handle 35 of the microcauter into the hollow probe 32 and are connected to the resistance element at the tip interiorly of the probe. The electrical conductors are connected to a suitable source of electrical current so that when current is supplied to the tip, it will be heated rapidly to a temperature sufficient to produce cauterization of the tissue defining the biopsy track. In this regard, it will be noted that the microcauter may be inserted into and through the biopsy needle 11 so that the tip 31 of the microcauter projects exteriorly thereof. The probe 32 is provided with a small cylindrical spacer element 36 which is adapted to engage the inner surface of the needle adjacent the proximal end thereof to space the the probe from the inner surface of the biopsy needle.

An alternative heat transfer means comprises a cryoprobe illustrated in FIG. 3 and designated generally by the reference numeral 37. The cryoprobe 37 includes an elongate substantially solid metallic probe 38 which is preferably formed of a material such as silver or the like which is characterized by its high thermal conductivity. The probe is of a length corresponding to the length of the hollow probe 32 of the microcauter 31. The proximal end portion of the probe 38 is connected to a reservoir 39 and a handle 40 is secured to the proximal end portion of the reservoir 39. A small cylindrical spacer element 41 is positioned concentrically around the proximal end portion of the probe 38 and serves to space the probe from the inner surface of the needle 11 when the cryoprobe is inserted into the needle.

A pair of conduits 42 extend through the handle 40 and communicate with the interior of the reservoir 39 to circulate liquid nitrogen through the reservoir 39 from a source of supply. In this regard, the conduits are also connected to a source of supply of liquid nitrogen with suitable means being provided to force the liquid nitrogen through the conduits. Suitable valving will also be provided. It will therefore be seen that when liquid nitrogen is circulated through the reservoir, because of the high thermal conductivity of the probe 38, the probe will be cooled to a temperature of approximately -180.degree. C. so that the temperature of the tip of the probe is approximately -100.degree. C. This is sufficiently cold enough to produce freezing of the tissue defining the biopsy track and to prevent any further bleeding thereof.

Referring now to FIG. 4, it will be seen that a modified form of the distal cutting edge of the biopsy needle is there shown and this cutting edge is designated by the reference numeral 42. It is pointed out that the biopsy needle of which the cutting edge 42 constitutes the distal end thereof is otherwise of identical construction to the biopsy needle illustrated in FIGS. 1 and 2, and includes a tubular body (not shown) having a uniformly tapered distal end portion 43. The cutting edge 42 is provided with a pair of diametrically opposed teeth 44 which project axially of the needle. Each tooth 44 defines an axial cutting edge 45 which is disposed substantially parallel to the longitudinal axis of the needle. These axial cutting edges 45 are of substantially the same length and the points of the teeth are disposed in substantially coplanar relation.

The cutting surface defined between each axial cutting edge 45 is generally of spiralled configuration and facilitates the cutting of a tissue as the needle is urged forwardly in an axial direction. However, the axial cutting edges 45 permit radial cutting when the needle is revolved about its longitudinal axis. It is also pointed out that the needle illustrated in FIG. 4 will also be provided with a stylet having a distal end configuration which will present a closed end surface to facilitate insertion of the needle for access to a deeply located organ.

In use, the sleeve member 19 will be releasably interlocked within the biopsy needle 11 and the stylet 26 will be interlocked within the sleeve member 19. The assembled needle device 10 will then be inserted from the exterior through the exterior tissue to the more deeply located organ such as a thyroid or spleen. When the distal end 14 of the needle 11 is disposed in close proximal relation to the organ from which the tissue specimen is to be taken the stylet 26 will be unlocked from the sleeve member 19 and retracted therefrom. The interlocked biopsy needle 11 and sleeve member 19 will then be advanced into the organ while simultaneously producing a revolving or oscillating movement of the assembly about its longitudinal axis. A tissue specimen will be cut by this augering action and will be collected in the distal end portion of the sleeve member 19 which, as set forth above, expands uniformly in a proximal direction. Because of this expansion configuration of the sleeve member, the tissue specimen will not be subjected to any compression as it is collected in the sleeve member, and the tissue specimen will therefore not be damaged. After the specimen has been collected within the sleeve member 19, the sleeve member will then be unlocked and retracted from the needle 11.

Thereafter, the microcauter 31 will be inserted through the needle so that the tip thereof projects into the biopsy track. The microcauter will be energized so that the tip instantaneously heats to a temperature sufficient to cauterize the biopsy track. The biopsy needle 11 and microcauter will be retracted as a unit thus producing cauterization of the entire biopsy track and thereby preventing any further bleeding of the organ.

As an alternative, the cryoprobe 37 may be inserted into the needle and the liquid nitrogen may then be circulated through the reservoir 39 so that instantaneous cooling of the probe 38 occurs. As pointed out above, the temperature of the liquid nitrogen is approximately -180.degree. C. and the temperature of the distal tip of the probe 38 is approximately -100.degree. C. This is sufficient to produce cooling to the degree necessary to prevent any further bleeding of the tissue. The biopsy needle 11 and cryoprobe 37 will also be retracted as a unit so that the biopsy track is progressively and effectively cooled.

It has been found that through the use of the above-described technique and biopsy device, not only can highly effective tissue specimens be obtained, but biopsies may be performed on such organs as the spleen, thyroid and the like through nonsurgical techniques. Profuse bleeding of such organs is prevented by the unique application of heat transfer means such as a cryoprobe or microcauter, which are introduced through the biopsy needle. Therefore, biopsy specimens may be taken from the spleen, thyroid or similar organs with a minimum of discomfort to the patient. Since little damage occurs to the specimen taken, it has been found that there is little, if any, occasion to repeat the biopsy.

It will therefore be seen from the preceding paragraphs that we have provided a novel technique and biopsy needle device which not only permits excellent specimens to be obtained but such specimens may be obtained from organs such as the spleen, the thyroid and the like through nonsurgical techniques.

It will, of course, be understood that various changes may be made in the form, details, arrangement and proportions of the various parts without departing from the scope of my invention.

Claims

We claim:

1. A method of obtaining a biopsy specimen from an organ such as a spleen, thyroid or the like, said method comprising

penetrating and progressively advancing the distal end portion of an elongate hollow biopsy instrument assembly into a patient, but with the proximal end of the instrument assembly located exteriorly of the patient, the instrument assembly including a biopsy needle having a tissue-collecting medium located interiorly thereof, and an obstructing medium positioned interiorly of the tissue-collecting medium and obstructing the open end of the biopsy needle assembly,

continuing the advancement of the distal end portion of the needle assembly until the distal end portion of the assembly is disposed in close proximal relation to the organ from which the tissue is to be removed,

removing the obstructing medium from the assembly, and thereafter advancing the needle and tissue-collecting medium as a unit into the tissue whereby a tissue specimen is cut and collected in the tissue-collecting medium,

retracting the tissue-collecting medium from the needle through the proximal end thereof,

inserting a heat transfer medium into the needle and exteriorly of the distal end thereof, the heat transfer medium having a temperature substantially higher or substantially lower than the body temperature of the patient to perform cauterization of the tissue, retracting the needle and heat transfer medium from the biopsy track whereby the heat transfer medium serves to stop bleeding of the tissue, and continuing retractive movement of the needle and its heat transfer medium from the patient.

2. The method as defined in claim 1 wherein the tissue specimen collected in the tissue-collecting medium is progressively urged into an expanding collection zone during removal of the specimen from the patient.

3. The method as defined in claim 1 wherein said heat transfer medium heats the tissue defining the biopsy track to a differential temperature level sufficient to cauterize the same.

4. The method as defined in claim 1 wherein said heat transfer medium cools the tissue defining the biopsy track to a differential temperature level sufficient to completely stop any bleeding of the tissue.

5. A biopsy needle device comprising,

an elongate hollow biopsy needle having open distal and proximal ends, said distal end defining a cutting edge, said needle being of uniform cylindrical configuration throughout the major portion of its length, and having a distal end portion tapered generally uniformly toward the tip of the distal end,

an elongate hollow sleeve member positioned within said needle and corresponding in length and shape to said needle, said sleeve member having a bore formed therein and being of uniformly cylindrical configuration throughout the major portion of its length and defining a biopsy tissue receiving and retaining cavity adjacent the distal end thereof, and having a distal end portion with inner and outer diameters tapered generally uniformly toward the tip of the distal end and defining an opening to said bore,

an elongate stylet positioned within said sleeve and having a length dimension slightly greater than said sleeve and an outer diameter substantially equal to the inner diameter of said sleeve at the distal end thereof so that said stylet obstructs the distal end of the needle and sleeve to facilitate insertion of the needle, sleeve member, and stylet as a unit into a patient, whereby when said stylet is removed from the needle and sleeve after insertion into a tissue, and upon manipulation of the needle, the distal cutting edge of the needle will cut a tissue sample and the tissue sample will be collected in the tapered distal end portion of the sleeve.