CA1129746A - Biopsy apparatus and methods of constructing and utilizing same - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE
The present invention provides an apparatus for extracting biopsy samples and the like, comprising, in combination: an elongat-ed hollow outer cannula having open distal and proximal ends, said distal end defining a cutting edge; solid inner means corresponding generally in length and shape to said outer cannula and being adap-ted to be tightly received within said hollow outer cannula for initial penetration of the body tissue; a hollow inner cannula adapted to be received within said hollow outer cannula after said solid initial puncture means has been removed therefrom; said inner cannula having an elongated distal cutting end section which projects beyond the distal cutting edge of said outer cannula when said inner cannula is introduced thereinto in operative position;
and said distal cutting end section of said inner cannula having disposed therein cutting means for cutting the body tissue as the inner cannula is withdrawn from the body and thus causing the tissue sample to be collected interiorly of the hollow inner cannula.

Description

The present invention relates generally to apparatus for use in connection with obtaining biopsy specimens such as, for example, from the breast, thyroid, solid tumors, bone marrow, liver, kidney, pleura, synovia, and other soft tissue~ ~
This application is a divisional application of copending application No. 277,928 filed May 9, 1977.
Heretofore, there has not been developed any generally acceptable and workable biopsy device which lends itself to neatly and relatively painlessly removing a biopsy tissue sample from a patient and at the same time providing easy removability of the specimen from the device without endangering the patient or the quality of the extracted specimen.
Among the biopsy devices disclosed to date are those described'in Uni-ted States Patent Numbers 2,5~1,5~2; 3,628,524;
3,800,783; 3,893,g~5; and 3,913,566. Such prior art devices have employed methods for extracting specimens such as, for example, be means of rotation of a needle device, be means of a loop of cutting thread disposed on a cannula, by means of a hooked blade arranged within a removable specimengathering sheath, or by means of a cutting tube disposed within a hollow handle, amongst other things. Such devices, however, have not satisfactorily met'the demand for a safe biopsy instrument which is capable of producing satisfactory specimens.
The present invention eliminates the disadvantages and shortcomings attendant all of these conventional prior art devices ' by providing a biopsy apparatus having an improved construction to reduce trauma to the patient and to provide a high quality tissue specimen without endangering either the patient or the extracted specimen.
Summary of the Inve'nt'i'on The present invention provides an apparatus for extract-ing biopsy samples and the like. The apparatus includes an elon-'' ~

gated hollow outer cannula having open distal and proximal ends, the distal end defining a cutting edge. Solid inner means corres-ponding generally in length and shape to the outer cannula is provided which is adapted to be tightly received within the hollow outer cannula for initial penetra-tion of the body tissue.
A hollow inner cannula adapted to be received within the hollow outer cannula after thesolid initial puncture means has ~een re-moved therefrom is also provided, and the inner cannula has an elongated distal cutting end section which projects beyond the distal cutting edge of the outer cannula when the inner cannula is introduced thereinto inoperative position. Also, the distal cutting end section of the inner cannula has disposed therein cutting means for cutting the body tissue as the inner cannula is withdrawn from the body and thus causiny the tissue sample to be collected interiorly o~ the hollow inner cannula.
It is an object of the present invention to provide a biopsy apparatus having three main elements, including a hollow outer cannula havin~ disposed therein either a solid inner initial puncture trocar or a hollow inner cannula.
In accordance with a preferred embodiment of the present invention, the hollow inner cannula is provided with a novel distal cutting end section having disposed therein a truncated conical cutting section having its base adjacent the distal edge of the inner cannula so as to effect a specimen-cutting action upon withdrawal of the inner cannula ~rom the patient's body.
Optionally, there may be provided at least one sharp thread on the inner periphery of the novel inner cannula end section.
In copending application No. 277,928 there is disclosed and claimed a deviae for extracting biopsy samples and the like including an elongaged needle member having a distal and proximal end, the distal end defining a cutting edgefor initial penetration of thebody tissue. The needle member has disposed along at least 74~

a portion of the length thereof bod~ tissue cutting means. A
hollow cylindrical cutting tube of substantially uniform diameter having adistal and proximal end with the distal end defining a cutting edge is also provided. The tube is adapted to besubstan-tially tightly received over theneedle member having the cutting means disposed thereon, af~er the needle member has been penetrated into the body tissue. The distal cutting edge of the tube pro-jects beyond the distal cutting edge of the needle mem~er in the body tissue when the tube is disposed over the needle member in an operative position. The needle member and the tube are adapted to be withdrawn simultaneously fromthe body with the tissue sample being collected interiorly of the tube.
The body tlssue cutting means comprises a sharp helical thread disposed along a suhstantial portion of the length ofthe needle member to e~fect a tissue-cutting action when the needle member is rotated. The tissue sample is collected interiorly of the tube and between adjacent thread por-tions of the helical thread when the needle member and tube are simultaneously withdrawn from the body. Both the needle member andthe tube are provided with respective handles to aid in maneuvering same, with the handle of the needle member being adapted to permit the tube to be slid-ably received thereover. The distal cutting edge of the tube is defined by a substantially circular beveled distal end edge of the cylindrical cutting tube. In the operative position, the proximal end of the needle member projects beyond the proximal end of the - tube.
Another object of the invention i3 to provide a biopsy apparatus wherein the novel cutting end section of the inner can-nula is provided with a through hole to facilitate removal of an extracted specimen from the interior of the inner cannula and means are provided for inserting into the through hole to remove the specimen.

7~

~ urther objects and details for the present invention will become apparent to those s~illed in the art upon reading the following specification, appended claims and the accompanying drawing.
Brief Description' of the Drawings Figure 1 illustrates a side elevational view ofa prior art hollow outer cannula.
; Figure 2 depicts a side elevational view of a prior art solid inner puncture trocar.
Figure 3 illustrates a side elevational view of a hollow inner cannula with novel end section in accordance with the present invention.
Figure 4 depicts an enlarged sectional view ofthe novel end section shown in Figure 3 in accordance with a first embodi-rnent of the invention.
Figure 5 illustrates an enlarged sectional view of the novel end section shown inFigure 3 in accordance with a second embodiment ofthe invention.
Figure 6 depicts a view of the novel end section taken along line 6-6 of Figure 5.
Figure 7 illustrates a view ofthe novelend section taken along the line 7-7 in Figure 6.
Figure 8 illustrates a side elevational view of the as- ', sembled biopsy device in accordance with a preferred embodiment of the invention'of copending application No. 277,928.
Figure 9 depi¢ts a front elevational view of ~he inner needle member as inserted into the body, with the outer tube being partially inserted thereover in accordance with copending application No. 277,928.
Figure 10 depicts a front elevational view of the device of Figures 8'and 9 in'an operative position wherein'the' outer-'tube is fully inserted into the body tissue.

- _ ~ _ Figure 11 illustrates a front elevational view of the device of Figures 8 to 10 as theinner needle member and outer tube are being simultaneously withdrawn from the patient's body.
Figure 12 depicts an-enlarged cut-away sectional view of ' the specimen collected interiorly of the tube and between adjacent thread portions of the needle member in accordance with copending application No. 277,928.
With reference to Figure 1, there is shown a hollow outer cannula of conventional cons-truction. The cannula 1 includes a beveled disial end point 2 for penetration into the body tissue and a hub 3 of standard construction to permit gripping of the hub in the fingers of the user. Both the beveled distal end point 2 and the proximal'end 4 of the cannula 1 are open.
Figure 2 illustrates a solid inner initial puncture trocar 5 whichis also of standard construction. The trocar 5 corresponds generally in length and shape to the cannula 1 so as to fit snugly therein. The beveled distal end 6 of the trocar 5 is designed to match the beveled distal end 2 of the cannula 1. Upon insertionof the trocar 5into thecannula l,the respectivebeveled distalehds ofthe cannula 1 and trocar5 willalign with eachother and the hubportion 7 of thetrocar~5will extendbeyond theopen pr~ximal end 4Of the,cannula l-toper~it easyextraction of the X~ocar 5 from the cannula 1.
Referring now to Figure 3, there is shown a hollow inner , cannula 8 having a novel end section designated generally as 9.
The inner cannula 8 corresponds generally in shape to the outer ' cannula 1, and will thus also fit quite snugly into the outer cannula 1. Upon insertion of the inner cannula 8 into the outer cannula 1, the novel end section 9 of inner cannula 8 will extend approximately 3 cm beyond'the open distal end 2 of the outer cannula 1, and the hub portion 10 of inner cannula 8 will extend ,sufficiently beyond open end 4 of outer cannula 1 so as to permit easy maneuvering of the inner cannula 8 within the 7~;

outer cannula 1.
It should be noted -that the outer cannula 1, the inner trocar 5 and the inner cannula ~ may be constructed of standard materials commonly used in the manufacture of surgical instruments~
For example, sta~nless steel, polyurethane, or other suitable surgical material may be employed.
In operation, the trocar 5 is first inserted into the hollow outer cannula 1. The trocar-cannula apparatus is next : inserted into the patient's body at the desired specimen extracting location. Ihebeveled end 2 of outer cannula 1 having the beveled end 6 of trocar 5 aligned therein thus serves to penetrate the body tissue. Thesolid inner trocar 5 serves as a guide for the outer cannula lduring insertionand alsoprevents body tissue fro:m entering the hollowouter cannulal. Afterfull inser-tion; the trocar5 iswith-drawn cornpletely from the outer cannula 1 while the outer cannula 1 remains stationary in the patient's body.
Next, the inner cannula 8 is completely inserted into the outer cannula 1 so that the novel end section 9 extends approx-imately 3 cm beyond the open distal end 2 of outer.cannula 1.
The end section 9 of inner cannula 8 may preferably have disposed therein a truncated conical cutting section 11 having its base adjaeent the distal ed~e 13 of the inner cannula 8, as depicted in Figure 4. The coni.cal cutting section 11 perfarms a cutting action by means of its sharp truncated edge 12. Preferably, the angular space formed between the conical cutting section 11 and the interior of the end section 9 is at least partiall~ solid so as to prevent the specimen from becoming trapped therein. It can thus be seen that when the inner cannula 8 is withdrawn from the patient's body, the truncated edge 12 of the conical cutting section 11 will ~erform a cutting action and cause body tissue to accumulate interiorly of the end section 9 during the withdrawal operation. It should be noted that the outer cannula and inner cannula 8 are preferably wi-thdrawn simultaneously from the pat~
ient's body. The specimen collected interiorly of the end section 9 will be approximately 2.5 cm to 3 cm in length, due to the 3 cm length of end section 9 which protrudes beyond distal end 2 of outer cannula 1.
Referring now to Figure 5, there is illustrated a second : embodiment of the novel end gection gof inner cannula 8. In addition to the truncated conical cutting section 11, the interiox surface of the end section 9 is further provided with sharp cutting . 10 ~ threads 14. The cutting threads 14 are shaped in a manner so as to aid the truncated conical cutting section 11 in cutting and retaining the body tissue interiorly of the end section 9 upon withdrawal thereof from the patient's body. With -the provision o~ cutting threads 14, and also in any desired application of the invention, it is beneficial to rotate the inner cannula 8 before withdrawal from the patient's body, while the outer cannula 1 remains stationary. Such rotating action will not be traumatic to the'patient since the outer cannula 1 remains stationary, and will serve to aid in the cutting action performed by the cutting means of end section 9.
As depicted in Figures 4, 5 and 6, the novel end section 9 of inner cannula ~ is provided with a through hole 15. After the inner cannula 8 and the outer cannula 1 have been simultaneously withdrawn from the patient's body, the inner cannula 8 is thereafter entirely withdrawn from the outer cannula 1. The extracted speci-men which is contained in-teriorly of the end section 9 is there-after easily removed from the end section 9 via the through 'hole' 15. This can be performed, for example, by inserting a wire 16 (Figure 4) or'other suitable implement into the through hole 15 to aid in extracting the specimen therefrom'. As shown in'Yigure 7, the through hole preferably consumes 90 of either side of the cylindrical periphery of the end section 9.

-- 8 -- .

.

With reference to Figure 8, there is depicted a novel rotary biopsy device according to the invention of copending application No. 277,928. The device includes an elongated needle member 17 which is shown as disposed within a hollow cylindrical cutting tube 21. Both the needle 17 and the tube 21 are of uni-form diameter. The needle 17 has provided on the proximal end thereof a handle 31 which is of slightly larger dia~eter than the needle 17 but which is of sufficiently minimal diameter to permit the tube 21 of somewhat larger diamter, to slide thereover. As can be seen inthe cut-away portion of the tube 21, the needle 17 has disposed along a suitable length thereof a helical thread 41. The thread 41 has an acutely sharp edge to facilitate the cuttiny action as well as the specimen retaining action which will be described in greater detail hereinbelow. Disposed adjacent the proximal end of the tube 21 is a handle portion 51. The handle 51 is fabricated of a rod portion 5a which extends substantially perpendicular to the longitùdinal axis of the tube 21 and a knob 5b secured to theend of rod 5a.
The distal end 61 of the needle 17 comprises a sharp - 20 needle point which permits the initial penetration of the needle - 17 into the patient's body to be relatively painless with minimal trauma. The distal end 71 of the tube 21 also comprises a sharp cutting edge as will now be described with reference to Figure 9.
Although the device as depicted in Figure 8 illustrates the needle 17 as being disposed within the tube 21, it will now be understood with respect to Figure 9 that initially the needle 17 and tube 21 are completely separated. To commence the specimen-obtaining procedure, the needle 17 is employed, via the sharp point 61, to initially puncture the layer of skin 81 of the patient's body. Next, to facilitate penetration of the needle 17 into the body tissue 91, the needle 17 is rotated, by rotating the handle 31 of the needle 17 in the direction of the arrow shown in Figure 9. Upon rotation, the sharp helical thread 41 disposed al'ong the length oflneedle 17 permits the needle 17 to be worked into the patient's body with minimal pain and trauma to the'patient After the needle 17 has been rotated and penetrated into the body tissue 91 to the desired position, the outer tube 21 is slidably positioned over the needle 17 and pushed downwardly to-wards the skin 8. In this connection, it should be noted with respect to Figures 8-12 that the inside diameter of the tube 21 is only slightly larger than the combined diameter of the ne'edle 17 and the helical thread 41 disposed thereon, to just ensure a substantially tight fit between the needle 17 and the tube 21 inserted thereover. As can be seen in Figure 9, the sharp distal cutting edge 71 of the tube 21 comprises a beveled end edge thereof which is substantially circular in configuration. The edge 71 is extremely sharp to effect easy penetration of the tube 21 into the skin layer 8 and subsequently into the body tissue 91.
Refereing now to Figure 10, the tube 21 is illustrated as fully inserted into body tissue 91 in its operative position.
The tube 21 has been pushed downwardly in the direction ofthe arrow shown in Figure 10, and it should be noted that no rotational movement of the tube 21 is necessary to effect penetration, and indeed a pushing action is all that is required. In this connec-tion, the handle 51 for the tube 21 (Figure 8) is employed to faci-litate maneuvering of the tube 21 with respect to the needle 17 and the patient's body. Also, it should be noted that as the tube 21 is pushed downwardly over ~heneedle 17, the needle 17 ' remains substantially stationary, and in effect serves as a'guide for the tube 21 as it is inserted. When the needle 17 and tube 21 are in the relative positions depicted in Figure 10, the proximal end of the needle 17 including the handle 31 will be projected outwardly above the proximal end of the tube 21 as can be more ~?,~37~
clearly seen in Figure 8. Moreover, the distal cutting edge 71 will project into the body tissue 91 outwardly of the cutting point 61 of needle 17 as depicted in Figures 8 and 10.
With reference now to Figure 11, the withd.rawal operation.
of the device will now be described. The tube 21 and needle 17 are withdrawn substantially simultaneously from the position shown in Figure 10 to that shown in Figure 11 in the direction of the arrow depicted in Figure 11. In this connection, it should be noted that as the tube 21 and needle 17 are withdrawn from the - 10 patient's body norotational movement is required. As the tube 21 and needle 17 are withdrawn the tissue specimen will be collected interiorly of the tube 21 between the slight space provided between the inside diameter of the tube 21 and the needle 17.
The major portion of the specimen will be effectivel~v contained betwe~n adjacent thread portions o~ the sharp heli.cal thread ~1 and in this manner a fairl~ larye and entirely ade~ual:e specimen size can be collected and extracted from the patient's body, with mini-mal pain or trauma tothe patient.
Referring now to Figure 12 an enlarged view of the ob-tained specimen 18 is depicted. It can be seen that the speci-men is collected in the slight space present between the inside diameter of the tube 21 and the needle 17. The thread 41 substan-tia].ly aids in collecting.and retaining the specimen to be extract-.
ed. Thus, the helical thread 41 serves two important functions.
First, upon insertion of the needle 17 into the patient's body-as described hereinabove, the sharp thread 41 serves to cut the skin and tissue during the rotational movement of theneedle 17 to facilitate penetration thereof into the patient's body. ~econdly, upon withdrawal of the needle 17 within the tube 21, the thread 41 functions to collect and retain the specimen sample being ex-tracted.

After the device, with the specimen contained therein, has been fully withdrawn from the patient's body, thedevice may again be separated and the specimen simply and effectively removed therefrom with the use of suitable tools.
It should be noted that the needle 17 and tube 21 may b~
constructed of standard ma-terials commonly used in the manu-facture of surgical instruments. For example, stainless steel, polyurethane, or other suitable surgical material may be employed.
Although there have been described what are at present considered to be the preferred embodiments of the invention, it will be understood that various modifications may be made therein, and it is intended to cover in the appended claims all such modificat.ions as fall within the truè spirit and scope of the invention.

Claims (2)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. An apparatus for extracting biopsy samples and the like, comprising, in combination: an elongated hollow outer can-nula having open distal and proximal ends, said distal end defin-ing a cutting edge; solid inner means corresponding generally in length and shape to said outer cannula and being adapted to be tightly received within said hollow outer cannula for initial pen-etration of the body tissue; a hollow inner cannula adapted to be received within said hollow outer cannula after said solid initial puncture means has been removed therefrom; said inner cannula having an elongated distal cutting end section which projects be-yond the distal cutting edge of said outer cannula when said inner cannula is introduced thereinto in operative position; and said distal cutting end section of said inner cannula having disposed therein cutting means for cutting the body tissue as the inner cannula is withdrawn from the body and thus causing the tissue sample to be collected interiorly of the hollow inner cannula.

2. The apparatus as defined in claim 1 wherein: said distal cutting end section of said inner cannula is provided with a through hole to facilitate removal of an extracted specimen from the interior of said inner cannula; and means are provided for inserting into said through hole to remove the specimen.