US3882849A - Soft Tissue Biopsy Device - Google Patents

Abstract

A soft tissue biopsy aspirating device for gathering soft tissue samples comprising a syringe having a barrel, with a reciprocably movable plunger sealingly received within the barrel to form a chamber with a controllably variable volume, and with a hollow sample-receiving needle mounted on a needle mounting boss attached to the barrel. The needle mounting boss has a rigid needle mounting shaft coupled on the end thereof, the shaft having a bore formed therein with a longitudinal segment and a radial segment to provide communication between the hollow core of the needle and the barrel with sample blocking means having an angularly disposed abutment surface thereon being provided to arrest inward motion of the sample and retain the sample so obtained in a stable position to prevent direct contact between the sample and the bore formed in the shaft. The plunger is secured to the conventional gripping shaft, and the gripping shaft has means for releasably engaging the proximate end of the barrel at controllable axial dispositions therealong. In use, the needle is used to puncture the body, and the tip of the needle is advanced until it reaches a point adjacent the organ from which the soft tissue is to be collected. At this point, the plunger is withdrawn and locked into engagement with the barrel, so as to form a partial vacuum within the barrel. The advancement of the needle is continued, thereby gathering a sample of tissue from the desired organ, with the tissue sample moving into the needle shank until contact is made with the abutment surface. The rigid needle mounting shaft supports and stabilizes the needle.

Description

United States Patent [1 1 J amshidi [4 1 May 13,1975

[ SOFT TISSUE BIOPSY DEVICE Khosrow Jamshidi, 610 Winston Ct., St. Paul, Minn. 55118 [76] Inventor:

[52] US. Cl 128/2 B; 128/218 C; 128/347; 128/329 [51] Int. Cl A61b 10/00 [58] Field of Search 128/2 8,2 R, 310, 329, 128/347, 278, 218 C [56] References Cited UNITED STATES PATENTS 2,844,148 7/1958 Raife 128/218 C 2,869,541 l/l959 Helmer et al. 128/218 C 3,330,268 7/1967 Goldsmith 128/2 B 3,470,867 10/1969 Goldsmith 128/2 B 3,540,447 11/1970 Howe et al... 3,628,524 12/1971 Jamshidi 3,727,602 4/1973 I-Iyden et al. 128/2 B FOREIGN PATENTS OR APPLICATIONS 587,586 l/l959 Italy 128/2 B Primary Examiner-Kyle L. Howell [5 7] ABSTRACT A soft tissue biopsy aspirating device for gathering soft tissue samples comprising a syringe having a barrel,

with a reciprocably movable plunger sealingly received within the barrel to form a chamber with a controllably variable volume, and with a hollow samplereceiving needle mounted on a needle mounting boss attached to the barrel. The needle mounting boss has a rigid needle mounting shaft coupled on the end thereof, the shaft having a bore formed therein with a longitudinal segment and a radial segment to provide communication between the hollow core of the needle and the barrel with sample blocking means having an angularly disposed abutment surface thereon being provided to arrest inward motion of the sample and retain the sample so obtained in a stable position to prevent direct contact between the sample and the bore formed in the shaft. The plunger is secured to the conventional gripping shaft, and the gripping shaft has means for releasably engaging the proximate end of the barrel at controllable axial dispositions therealong. In use, the needle is used to puncture the body, and the tip of the needle is advanced until it reaches a point adjacent the organ from which the soft tissue is to be collected. At this point, the plunger is withdrawn and locked into engagement with the barrel, so as to form a partial vacuum within the barrel. The advancement of the needle is continued, thereby gathering a sample of tissue from the desired organ, with the tissue sample moving into the needle shank until contact is made with the abutment surface. The rigid needle mounting shaft supports and stabilizes the needle.

9 Claims, 6 Drawing Figures PATENTED HAY l 3|975 SOFT TISSUE BIOPSY DEVICE CROSS-REFERENCE TO RELATED APPLICATION The present application relates to a device which is an improvement over that disclosed and claimed in copending application Ser. No. 330,320, filed Feb. 7, 1973, entitled SOFT TISSUE BIOPSY ASPIRATING DEVICE AND METHOD OF USING SAME, which application formed a continuation-in-part of then copending application Ser. No. 261,8l8, filed June 12, 1972 and entitled SOFT TISSUE BIOPSY ASPIRAT- ING DEVICE AND METHOD OF USING SAME, now abandoned. 4

BACKGROUND OF THE INVENTION The present invention relates generally to an improved biopsy aspirating device for obtaining tissue samples, and more particularly, to an improved biopsy aspirating device particularly designed to gather tissue samples of soft tissue organs, such as liver, kidney, spleen, thyroid or the like. The apparatus of the present invention is particularly adapted to obtain tissue samples without requiring unusual surgical procedures, and without requiring that large openings be formed within the body; and is further adapted to retain such samples without exposing the sample structure to risk of damage due to the exertion of unusual forces upon the substance of the tissue sample. The apparatus of the present invention is also designed so as to provide means for supporting, stabilizing, and mechanically reinforcing the hollow needle, the hollow needle devices nor mally being fabricated from thin-walled stainless steel tubing, and frequently being brittle and subject to breakage during use.

At the present time, a variety of specific biopsy instruments are being utilized for obtaining biopsy test specimens from various organs, however, such instruments are normally cumbersome when being utilized for obtaining biopsy specimens from internally disposed organs which tend to bleed profusely when specimens are removed therefrom. It is deemed desirable, therefore, to utilize a device which reduces the complexity of the procedure for the operator, thereby reducing the risk of complications resulting therefrom; and also to utilize apparatus which neither damages nor destroys the specimen when obtained.

SUMMARY OF THE INVENTION Briefly, in accordance with the present invention, a biopsy aspirating device is provided which is specifically adapted for gathering soft tissue samples, and comprises a syringe having a barrel, a plunger which is sealingly received for reciprocatory motion within the barrel to form a chamber with a controllably variable volume, and with a sample receiving hollow needle having a sharpened tip being disposed on the end of the barrel. The syringe is provided with needle mounting boss means for being received within the hub of the needle, with a bore being formed in the boss to provide communication between the needle bore and the barrel chamber. An inner reinforcing shaft is provided, with this shaft being mounted within the boss, and having a bore formed therein which provides direct communication between the barrel chamber and the needle bore. The bore formed in the shaft is provided with an off-set segment which extends radially outwardly to the peripheral surface of the shaft, thereby minimizing the risk of any portion of the sample coming into contact with the communication link between the barrel chamber and the needle bore. Furthermore, the shaft has an abutment surface at the forward end thereof, with this abutment surface being provided to engage the sample and retain the sample in a position to prevent direct contact between the sample and the bore formed in the boss. The shaft is closely spaced from the interior walls of the hollow needle, thus providing a reinforcing or supporting core for the hollow needle. The needle plunger is provided with a gripping shaft having locking means for retaining the plunger at a point removed from the base of the barrel, so as to maintain a controlled partial vacuum within the chamber. In use, the needle is inserted into the patient until the distal tip is disposed immediately adjacent the organ from which the sample is to be obtained. The plunger is then withdrawn or retracted within the barrel and locked in place so as to create and maintain a partial vacuum within the chamber. With the plunger retained in locked disposition, the needle is immediately advanced until the tip penetrates the organ, and when advancement ceases, the partial vacuum present in the chamber will extract the sample from the organ and draw it further into the needle bore until contact is made with the abutment surface. The abutment surface formed at the tip of the shaft prevents the sample from passing along the length of the needle and into contact with the opening of the bore formed in the boss, thereby preserving the integrity of the sample at a point within the needle bore and inwardly from the needle tip. If desired, after removal of the biopsy needle, a cauterizing device or cryoprobe may be inserted into the opening formed by the needle for the purpose of cauterizing the wound formed along the biopsy track.

Therefore, it is a primary object of the present invention to provide apparatus and technique for obtaining biopsy samples or specimens from soft tissue organs such as liver, kidney, spleen or they like, with means being provided for controllably positioning the sample against an abutment surface, thereby maintaining the integrity of the sample while continuously subjecting the sample to an aspirating force.

It is a further object of the present invention to provide apparatus and technique for obtaining biopsy samples or specimens from soft tissue organs pursuant to a simplified technique and without requiring those moderately extensive surgical procedures which may at times be required.

It isyet a further object of the present invention to provide improved apparatus and technique for obtaining biopsy samples or specimens from soft tissue organs wherein the sample is maintained in a condition free from exposure to unusual forces.

Other and further objects of the present invention will become apparent to those skilled in the art upon a study of the following specification, appended claims, and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view of the biopsy aspirating device fabricated in accordance with the present invention, and showing the disposition of the plunger and its gripping handle partially removed from the base of the barrel;

FIG. 2 is a view similar to FIG. 1 and showing the disposition of the plunger when removed a substantial distance from the base of the barrel and with a segment of the hollow needle being cut away so as to expose the needle mounting shaft therewithin;

FIG. 3 is a perspective view of the proximate end only of the apparatus shown in FIGS. 1 and 2, with the remainder being broken away;

FIG. 4 is an end view, on a slightly enlarged scale illustrating the proximate end of the structure, and with a portion of the plunger member being shown in section and in unlocked disposition with the barrel structure;

FIG. 5 is a view similar to FIG. 4 and illustrating the plunger in locked disposition with the barrel; and

FIG. 6 is a vertical sectional view, on a significantly enlarged scale, illustrating the details of the needle and needle supporting shaft.

DESCRIPTION OF THE PREFERRED EMBODIMENT In accordance with the preferred embodiment of the present invention, particular attention is initially directed to FIGS. 1, 2 and 6 of the drawings wherein the preferred modification of the structure is illustrated in detail. Essentially, the biopsy aspirating device generally designated 11) includes abarrel member 11 having aplunger 12 sealingly received within the barrel and forming a chamber zone as at 13. A sample-receivinghollow needle 15 is provided having a sharpenedtip 16 and ahub 17 for locking onto the tip end of thebarrel 11 with the sample receivinghollow needle 15 having a shank portion interposed between the sharpenedtip 16 and thehub 17.

A needle mounting boss means 20 is arranged at the distal or tip end ofbarrel 11, with the boss means 20 extending from the barrel with needle hub-receivingsurface 21 being disposed therealong.Needle mounting shaft 22 having aninner end portion 23 disposed within the confines ofboss 20, and with the free end of the needle mounting shaft being disposed coaxially within the bore of thehollow needle 15. A longitudinal bore segment is provided as at 23A, with a radial segment being provided at 238 in order to achieve continuous communication between thechamber Zone 13 ofbarrel 11 and the hollow core portion ofneedle 15. As illustrated in FIG. 6, theforward end portion 24 ofneedle mounting shaft 22 is an angularly disposed abutment surface for making contact with soft tissue samples entering the core ofneedle 15. In other words, the abutment surface provides a blocking surface which avoids exposing the tissue sample to an unusual concentration of forces or pressures. This feature will be discussed in detail hereinafter.

It will be further observed that the boss means 20 is arranged to be received within thehub 17. The bore segments 23A and 2313 inneedle mounting shaft 22 may be small in diameter, and in particular, small relative to the inner diameter of thehollow needle 15. This permits gaseous fluids to freely pass through the needle, as well as blood and other body fluids, while preventing the biopsy specimen from entering the syringe. For example, this diameter may range from about 20 and of the diameter of the shank ofneedle 15, the needle shank commonly having an inner diameter of about 0.05 inch.

With continued attention being directed to FIGS. 1, 2 and 6, it will be observed thatplunger 12 is secured to grippingshaft 30, with grippingshaft 30 extending outwardly from the barrel and terminating indisk 31. FIG. 2 illustrates thegripping shaft 30 having an irregular external periphery or configuration, with the crosssection including acentral shaft portion 33 along with a pair of radially extending ears 3434 and detents (see FIG. 4). Theshaft portion 33 along with the ears 3434 are arranged to be received within the confines ofbore 35 formed inplate 36, with thebore 35 including a central open portion along with radially inwardly extending members 37-37. The purpose for utilizing or providing the radially extending members 3737 will be made manifest hereinafter. With continued attention being directed to FIGS. 2 and 4, it will be seen that the radially extending ears 34-34 are provided for the purpose of engaging members 3737 and holding or otherwise retaining the grippingshaft 30 in partially or fully retracted position. This retracted disposition enables the user to reduce the pressure within thebarrel 11, and thus establish a partial vacuum in the chamber communicating withneedle 15. This partial vacuum assists in retracting the biopsy sample from the organ being examined, such as asample 38, into the confines ofneedle 15.

As has been indicated, the technique normally employed in connection with the devices shown in FIGS. 16 is to initially advance theneedle 15 into the body of the patient from which the biopsy sample is to be obtained, with the advancement of the needle continuing until a point is reached immediately adjacent or short of the pertinent organ. The gripping shaft is then retracted to a point at which the lugs will lock onto the surface ofmember 36 at 37-37, and the shaft is then rotated arcuately so as to engage the members 3737 with the individual ears 3434. Thechamber 13 disposed within thebarrel 11 is thereby evacuated and a partial vacuum is formed. The needle is then advanced further with a stabbing motion so as to contact or penetrate the pertinent organ, whereupon, when needle advancement ceases, the sample is extracted from the organ and drawn into the confines of theneedle 15. Such a sample is shown at 38 as indicated in FIG. 6.

For achieving the results with the structure of the present invention, and with particular attention being directed to FIG. 6, the tip end of theneedle shank 16 is tapered inwardly, as illustrated at 40 in FIG. 6, this inward tapering being accomplished in order to provide a wider receptacle area in the bore for the sample than is available at the tip or cutting edge. In this connection, an outwardly tapering angle of between about 5 and 15 is considered optimum. With this construction, therefore, the sample is free to move inwardly of the core of the needle shank, and the mounting shaft blocks inward movement of the sample without damaging the sample. In this connection, therefore, the outer diameter of the sample is preferably about the same diameter as the diameter ofneedle mounting shaft 22.

Therefore,abutment surface 24 provides an angularly disposed blocking means to effectively prevent continued inner movement oftissue sample 38 without blocking the air flow channel and with a small or minimal area of contact. This abutment surface further is useful in preventing the transfer of any portion of thetissue sample 38 to the interior ofchamber 13 under the influence of vacuum.

In certain applications of the soft tissue biopsy device of the present invention, a liver biopsy may be taken in the transcostal approach. In this approach, contact with the rib surface may cause sufficient deflection of the needle to cause fracture. Theneedle mounting shaft 22 provides a support for the needle shaft per se, and this support reduces the tendency toward breakage. Preferably,needle mouonting shaft 22 is prepared from stainless steel and thus is rigid and durable. Furthermore, this structure is securely held in place in the device by being retained directly within the inner core ofboss 20.

Also, as has been indicated, theabutment surface 24 is angularly disposed, and the communicating bore betweenchamber 13 and the core ofneedle 15 includes the segments 23A and 238, withsegment 23B being off-set sufficiently from the tip end ofneedle mounting shaft 22 so as to prevent direct contact between thesample 38 and thebore segment 23B. Such contact tends to apply concentrated forces against localized areas ofsample 38, and may cause damage or distortion of the sample, either from the surface or in the bulk.

Conventional materials of construction may be employed in these devices, with conventional plastic molded barrels and gripping shafts being desirable. Rubber plugs may be employed for the plunger means, and normal needle materials may be employed for the sample-receiving needle structures. For a general structure having substantial versatility and utility, tubing having an outer diameter of 1.4 mm, with a wall thickness of0.004 inch has been found to be desirable, along with a mounting shaft having an outer diameter of about 0.04 inch and wall thickness of 0.01 inch.

I claim:

1. Biopsy aspirating means for gathering soft tissue samples comprising:

a. syringe means having a barrel, a reciprocable plunger sealingly received within such barrel and forming a controllably variable volume chamber with the interior of said barrel, a sample-receiving hollow needle having a sharpened tip, and needle mounting boss means at the base of said barrel and extending from said barrel and having a means receiving the hub of said sample-receiving needle thereon;

b. a gripping shaft coupled to said plunger and extending outwardly from said barrel, guide plate means disposed at the proximate end of said barrel and having an opening formed therein to receive said gripping shaft, said gripping shaft having locking lug means formed thereon and arranged to releasably engage the outer surface of said guide plate means for retaining said plunger in a position removed from said barrel tip means;

c. said needle mounting boss means having a central bore formed therein, a rigid needle mounting shaft disposed within said bore, said needle mounting shaft having an angularly disposed biopsy sample abutment surface at the forward end thereof, a bore formed within said needle mounting shaft and providing communication between said barrel and said hollow needle shaft at an orifice at the end of said needle mounting shaft bore, said orifice being disposed at a point spaced a finite distance from said angularly disposed sample abutment surface, said angularly disposed abutment surface being received within the bore of said hollow needle and being disposed along said needle shaft at a point removed from the tip end of said needle.

2. The means for gathering soft tissue biopsy samples as defined in claim 1 and being particularly characterized in that said needle mounting boss means is compressible for grippingly engaging the inner diameter of said needle hub.

3. The means for gathering soft tissue biopsy samples as defined in claim 1 being particularly characterized in that said boss and angularly disposed abutment surface are formed integrally with said barrel, and form a continuation thereof.

4. The means for gathering soft tissue biopsy samples as defined in claim 1 being particularly characterized in that said locking lug means on said gripping shaft are radially spaced, and radially spaced locking lug means are formed on the outer surface of said guide plate for lockingly engaging the radially spaced locking lugs formed on said gripping shaft and wherein the radial spacing of each of said locking lug means facilitates free axial motion in one relative radial disposition, with locking being established between said gripping shaft and said guide plate in a second relative radial disposition.

5. The means for gathering soft tissue biopsy samples as defined in claim 1 being particularly characterized in that said sample abutment surface is formed along the forward wall of said rigid needle mounting shaft, and wherein said mounting shaft has a bore formed therein with a generally radially extending segment and providing communication between said barrel chamber and said hollow needle shaft, said radially extending segment being spaced inwardly of said abutment surface.

6. The means for gathering soft tissue biopsy samples as defined in claim 1 wherein said rigid needle mounting shaft is fabricated from stainless steel.

7. The means for gathering soft tissue biopsy samples as defined in claim 1 being particularly characterized in that the bore formed in said needle mounting shaft has a diameter approximately 20 to 30% of the inner diameter of the shank portion of said sample-receiving hollow needle.

8. The means for gathering soft tissue biopsy samples as defined in claim 1 being particularly characterized in that the inner diameter of said hollow core needle tapers inwardly at the outer tip end thereof so as to define a needle core opening having a diameter significantly less than the inner diameter of the shank portion thereof.

9. The means for gathering soft tissue biopsy samples as defined in claim 8 being particularly characterized in that said inner diameter of said hollow core needle tapers inwardly at an angle of between about 5 and 15.

Claims (9)

1. Biopsy aspirating means for gathering soft tissue samples comprising: a. syringe means having a barrel, a reciprocable plunger sealingly received within such barrel and forming a controllably variable volume chamber with the interior of said barrel, a sample-receiving hollow needle having a sharpened tip, and needle mounting boss means at the base of said barrel and extending from said barrel and having a means receiving the hub of said sample-receiving needle thereon; b. a gripping shaft coupled to said plunger and extending outwardly from said barrel, guide plate means disposed at the proximate end of said barrel and having an opening formed therein to receive said gripping shaft, said gripping shaft having locking lug means formed thereon and arranged to releasably engage the outer surface of said guide plate means for retaining said plunger in a position removed from said barrel tip means; c. said needle mounting boss means having a central bore formed therein, a rigid needle mounting shaft disposed within said bore, said needle mounting shaft having an angularly disposed biopsy sample abutment surface at the forward end thereof, a bore formed within said needle mounting shaft and providing communication between said barrel and said hollow needle shaft at an orifice at the end of said needle mounting shaft bore, said orifice being disposed at a point spaced a finite distance from said angularly disposed sample abutment surface, said angularly disposed abutment surface being received within the bore of said hollow needle and being disposed along said needle shaft at a point removed from the tip end of said needle.

2. The means for gathering soft tissue biopsy samples as defined in claim 1 and being particularly characterized in that said needle mounting boss means is compressible for grippingly engaging the inner diameter of said needle hub.

3. The means for gathering soft tissue biopsy samples as defined in claim 1 being particularly characterized in that said boss and angularly disposed abutment surface are formed integrally with said barrel, and form a continuation thereof.

4. The means for gathering soft tissue biopsy samples as defined in claim 1 being particularly characterized in that said locking lug means on said gripping shaft are radially spaced, and radially spaced locking lug means are formed on the outer surface of said guide plate for lockingly engaging the radially spaced locking lugs formed on said gripping shaft and wherein the radial spacing of each of said locking lug means facilitates free axial motioN in one relative radial disposition, with locking being established between said gripping shaft and said guide plate in a second relative radial disposition.

5. The means for gathering soft tissue biopsy samples as defined in claim 1 being particularly characterized in that said sample abutment surface is formed along the forward wall of said rigid needle mounting shaft, and wherein said mounting shaft has a bore formed therein with a generally radially extending segment and providing communication between said barrel chamber and said hollow needle shaft, said radially extending segment being spaced inwardly of said abutment surface.

6. The means for gathering soft tissue biopsy samples as defined in claim 1 wherein said rigid needle mounting shaft is fabricated from stainless steel.

7. The means for gathering soft tissue biopsy samples as defined in claim 1 being particularly characterized in that the bore formed in said needle mounting shaft has a diameter approximately 20 to 30% of the inner diameter of the shank portion of said sample-receiving hollow needle.

8. The means for gathering soft tissue biopsy samples as defined in claim 1 being particularly characterized in that the inner diameter of said hollow core needle tapers inwardly at the outer tip end thereof so as to define a needle core opening having a diameter significantly less than the inner diameter of the shank portion thereof.

9. The means for gathering soft tissue biopsy samples as defined in claim 8 being particularly characterized in that said inner diameter of said hollow core needle tapers inwardly at an angle of between about 5* and 15*.

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