WO2009027976A1

WO2009027976A1 - A biopsy gun useful for ergonomic and efficient biopsy and method thereof

Info

Publication number: WO2009027976A1
Application number: PCT/IL2008/001167
Authority: WO
Inventors: Ofer Gofrit
Original assignee: Hadasit Medical Research Services And Development Ltd.
Priority date: 2007-08-27
Filing date: 2008-08-27
Publication date: 2009-03-05

Abstract

The present invention provides a biopsy gun (100), useful for obtaining tissue samples; wherein the biopsy gun comprises: (a) a biopsy set (700), comprising a stylet (56), a stylet (56), having a distal end and a proximal end; said distal end comprises a recess (60); and, a cannula (58); (b) an engagement mechanism (200), for coupling said biopsy set (700) to said biopsy gun (100); (c) a two steps cocking mechanism (600), for cocking said biopsy set (700); (d) a firing mechanism (500) for actuating said biopsy set (700); (e) a sample size adjustment mechanism (900) for controlling the stroke length of said biopsy set (700); and, (f) a safety mechanism (300), for inhibiting undesired firing of said biopsy set (700).

Description

A BIOPSY GUN USEFUL FOR ERGONOMIC AND EFFICIENT BIOPSY

AND METHOD THEREOF

FIELD OF THE INVENTION

This invention generally relates to a device used to perform a biopsy, and a method of use of the device.

BACKGROUND OF THE INVENTION

Many diseases, mainly tumors, require analysis of tissue specimen, to determine the type of involved cells and the spread extent of the disease. This specimen is obtained either by fine needle aspiration or by core biopsy.

A core biopsy device usually comprises a coaxial system of a stylet needle- and a cannula. The stylet needle has a recess at its end, into which body tissue is compressed after insertion of the needle. The cannula then slides over the recess, cutting a tissue tube. three general types of biopsy devices are manufactured today: manual, in which the stylet and the cannula are inserted manually, semi automatic, in which the stylet is inserted manually but the cannμla is fired, improving the cutting mechanism, and fully automatic, in which both the stylet and the cannula are fired one after another.

The existing fully automatic biopsy guns therefore require dual cocking, of the stylet and of the cannula, and dual firing. Usually, the cocking requires the operation of two hands, and even in guns in .which a single hand is used, it is usually necessary to relocate it to cock each of the mechanism. These drawbacks are substantial when a less experience operater is performing the biopsy, when the biopsy tissue is located in a very small perimeter, when the biopsy is guided by an ultrasound device which is connected to the biopsy gun etc. all the above situations can result in a sample taken from the wrong place, in larger tissue damage, in greater pain and discomfort to the patient, and in insufficient tissue retrieval.

Most biopsy guns have an elongated shape, with a single axis aligned with the needle. This configuration isn't ergonomic, hard to manipulate and direct to the appropriate position in the patient body, and hard to maneuver in smaller cavities, such as biopsies through the vagina, the anus, the oral cavity etc. these areas require unusual angels, and an elongated shape strains the arm of the operator.

The sample size is an important factor when it comes to diagnosis. When possible, a large sample size is beneficial, because more tissue can be obtained with less punctures, thus reducing the trauma to the tissue. Conversely, in small organs, such as the^' prostate, it is imperative not to oversize the sample, so as not to harm adjacent structures. However, most biopsy guns are restricted to a single sample size by the length of the travel the stylet and the cannula make after fired.

Another important issue in automatic biopsy guns is safety - after cocking, the stylet or cannula are liable to fire accidentally if not properly secured, resulting in injury to adjacent tissue and even to the operator.

For example, automatic biopsy gun are used for the diagnosis of Prostate cancer. Carcinoma of the prostate is the most common malignancy in men, and the second leading cause of cancer deaths, accounting for 9% of all cancer deaths. The prostate is composed of two main anatomical zones as shown in Fig. 18 - the transitional zone the origin of benign prostatic hyperplasia, and the peripheral zone-the origin of CaP.

Carcinoma of the prostate is diagnosed exclusively by trans-rectal prostatic biopsy. As a routine, trans-rectal ultrasonic (TRUS) examination of the prostate is done immediately before the biopsy. The operator examines the echo-texture of the prostate and measures its size (Fig. 18). Then, biopsies are taken with a Tru-cut needle (Baxter General Healthcare, Deerfield, Illinois). The needle is inserted through the ultrasonic probe, and is guided into suspicious sites in the peripheral zone. If no suspicious sites can be identified, random biopsies are taken. The main desire in prostatic biopsy is to obtain the largest amount of tissue with minimal trauma to the patient.

A standard of 6 biopsies was agreed on in 1989. The number of biopsies has increased since than to 8, 10, 12 and even more cores. There are reports that more cores lead to a better detection rate and to a better accuracy rate when biopsy results are compared to the final pathological result from the radical prostatectomy specimen.'

The detection rate of cancer in sextant needle biopsies is higher as longer single cores are sampled, particularly at the apex. For example, a 20-mm core from the right apex provided a 27% probability of cancer detection versus 18% for a 10-mm core. The amount of tissue obtained by biopsy varies widely, and we found an overall tissue sample (likely to be an inadequate sample) smaller than 50mm in up to 4% of biopsies.

If a fixed number of biopsies are taken, detection rate decreases as prostatic size increases. Adjusting the number of biopsies taken from the prostate to the size of the gland seems a logical solution to the problem, and indeed it ^"was shown to increase the rate of positive biopsies.

Prostatic biopsy is an unpleasant procedure. The discomfort experienced during transrectal biopsy is proportional to the number of cores taken.

Thus, there is still a long felt need for a device that is ergonomic, operated single handedly, without the need to relocate the hand during cocking, has a safety mechanism to protect against premature firing and can change the sample size obtained. Additionally, it should be easy to operate by less experienced personnel, and allow the use of a disposable needle.

SUMMARY OF THE INVENTION

It is one object of the present invention to provide a biopsy gun (100), useful for obtaining tissue samples, wherein said biopsy gun comprising: a. a biopsy set (700), comprising: i. a stylet (56), a stylet (56), having a distal end and a proximal end; said distal end comprises a recess; and, ii. a cannula (58); b. an engagement mechanism (200), for coupling said biopsy set (700) to said biopsy gun (100); c. a two steps cocking mechanism (600), in communication with said biopsy set (700), for doubly cocking said biopsy set (700); d. a firing mechanism (500) in communication with said biopsy set (700) and with said cocking mechanism (600), for actuating said biopsy set (700); e. a sample size adjustment mechanism (900); and, f. a safety mechanism (300), for inhibiting undesired firing of said biopsy set (700); wherein the stroke length of said biopsy set (700) is controlled via said sample size adjustment mechanism (900).

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said biopsy gun additionally comprising means for adjusting the recess (60) length of said stylet (56), in a non limiting manner, from a group consisting of about 15mm, about 20mm and about 25 mm.

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said stylet (56) and said cannula (58) are adapted to different gauges.

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said biopsy set (700) is disposable and the gun itself is reusable.

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said safety mechanism (300) is adapted to lock said sample size adjustment mechanism (900).

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said biopsy gun (100) is ergonomic.

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein the shape of said biopsy gun (100) is-in a pistol shape.

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein a degree of about 100 to about 150 degrees between barrel and handle is provided for better ergonomic configuration.

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said biopsy gun (100) is operable by a single hand.

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said sample size adjustment mechanism (900) comprising means for attuning the stroke length of said biopsy set (700).

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said stroke length of said biopsy set (700) is attuned, in a non limiting manner, from a group consisting of about 15mm, 20mm and 25 mm.

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said sample size adjustment mechanism (900) comprises at least 3 possible positions.

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said cocking mechanism (600) comprises at least two steps. It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said first cocking step retracts said cannula (58); and, said second cocking step retracts said stylet (56).

It is another object of the present invention to provide biopsy gun (100) as defined above, wherein said first and second cocking are executed by pulling a cocking trigger (7) twice.

It is another object of the present invention to provide the biopsy gun (100) as defined above, wherein said firing mechanism comprises a firing trigger such that a single pull of a firing trigger (54) is adapted to actuate said stylet (56), followed by an automatic actuation of said cannula (58).

It is another object of the present invention to provide a method of performing biopsy (800) from a tissue to be sampled. The method comprises steps selected inter alia from: a. obtaining a biopsy gun (100) having: i. a biopsy set (700), comprising: a. a stylet (56), having a distal end and a proximal end; said distal end comprises a recess; and, b. a cannula (58); ii. an engagement mechanism (200), for coupling said biopsy set (700) to said biopsy gun (100); iii. a two steps cocking mechanism (600), for cocking said biopsy set (700); iv. a firing mechanism (500) for actuating said biopsy set (700); v. a sample size adjustment mechanism (900), controlling the stroke length of said biopsy set (700); and, vi. a safety mechanism (300), for inhibiting undesired firing of said biopsy set

(700); b. engaging said biopsy set (700) into the biopsy gun (100); c. first cocking said biopsy gun (100) thereby retracting said cannula (58); d. secondary cocking said biopsy gun (100) thereby retracting said stylet (56); e. adjusting a stroke length lever (14); f. pushing said safety button (20); thereby enabling the firing of said biopsy gun (100); g. introducing said biopsy gun (100) into a body portion to be treated and adjacent to said tissue to be sampled; h. activating said firing mechanism thereby firstly actuating said stylet (56); and secondly automatically actuating said cannula (58); i. extracting the biopsy gun (100) from said body portion; and, j. cocking said biopsy gun (100) thereby obtaining said tissue to be sampled from the stylet (56) recess.

It is another object of the present invention to provide the method as defined above, additionally comprising step of attuning the length of said recess (60) to values selected from a group consisting of about 15mm, about 20mm and about 25 mm.

It is another object of the present invention to provide the method as defined above, additionally comprising step of attuning said stylet (56) and said cannula (58) to different gauges.

It is another object of the present invention to provide the method as defined above, wherein said biopsy set (700) is disposable and the gun itself is reusable.

It is another object of the present ^■ invention to provide the method as defined above, additionally comprising step of locking said sample size adjustment mechanism (900) via said safety mechanism (300).

It is another object of the present invention to provide^" the method as defined above, wherein said biopsy gun (100) is ergonomic.

It is another object of the present invention to provide the method ^"as defined above, additionally comprising step of selecting the shape of said biopsy gun (100) from a pistol shape.

It is another object of the present invention to provide the method as defined above, wherein said biopsy gun (100) is operable by a single hand.

It is still an object of the present invention to provide the method as defined above, additionally comprising step of attuning the stroke length of said biopsy set (700).

It is lastly an object of the present invention to provide the method as defined above, additionally comprising step of selecting said stroke length of said biopsy set (700), in a non limiting manner, from a group consisting of about 15mm, 20mm and 25 mm. BRIEF DESCRIPTION OF FIGURES

In order to understand the invention and to see how it may be implemented in practice, a few preferred embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

Figure 1 schematically presents in an out-of-scale manner a biopsy set (700);

Figures 2 schematically shows anchorning of the biopsy set (700) into the engagement mechanism (200);

Figures 3a to 3c schematically show closing of the top cover (30) after insertion of the biopsy set (700);

Figures 4a to 4d schematically show first cocking;

Figures 5a to 5d schematically shows second cocking;

Figures 6a to 6b schematically show stroke length adjustment;

Figures 7a to 7e schematically show the safety mechanism;

Figures 8a to 8c schematically show the firing mechanism 500;

Figure 9 schematically shows the engagement mechanism (200) assembly;

Figure 10 schematically shows the relay mechanism (400) assembly;

Figure 11 schematically shows the safety mechanism (300) assembly;

Figure 12 schematically shows the pawl mechanism (500) assembly;

Figure 13 schematically shows the mechanism sub-assembly;

Figure 14 schematically shows the housing assembly;

Figure 15 disclosed a method of performing biopsy (800).

Figure 16 schematically shows biopsy of the prostate.

Figure 17 illustrate a real image of the biopsy gun of the present invention.

Figures 18-19 compares core biopsies taken with Tru-cut biopsy system and with the present invention. DETAILED DESCRIPTION OF THE DRAWINGS

1. The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide a biopsy gun which is useful for ergonomic and efficient biopsy.

2. It should also be appreciated that the above described description of methods and apparatus are to be interpreted as including apparatus for carrying out the methods, and methods of using the apparatus of any type as well known to a person or ordinary skill, and which need not be described in detail herein for enabling a person of ordinary skill to practice the invention.

3. For the main embodiments of the invention, the particular selection of type and model is not critical, though where specifically identified, this may be relevant. The present invention has been described using detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the' invention. No limitation, in general, or by way of words such as "may", "should", "preferably", "must".,- or other term denoting a degree of importance or motivation, should be considered as a limitation on the scope of the claims or their equivalents unless expressly present in such claim as a literal limitation on its scope. It should be understood that features and steps described with respect to one embodiment may be used with other embodiments and that not all embodiments of the invention have all of the features and/or steps shown in a particular figure or described with respect to one of the embodiments. That is, the disclosure should be considered complete from combinatorial point of view, with each embodiment of each element considered disclosed in conjunction with each other embodiment of each element (and indeed in various combinations of compatible implementations of variations in the same element). Variations of embodiments described will occur to persons of the art. Furthermore, the terms "comprise," "include," "have" and their conjugates, shall mean, when used in the claims, "including but not necessarily limited to." Each element present in the claims in the singular shall mean one or more element as claimed, and when an option is provided for one or more of a group, it shall be interpreted to mean that the claim requires only one member selected from the various options, and shall not require one of each option. The abstract shall not be interpreted as limiting on the scope of the application or claims. 4. It is noted that some of the above described embodiments may describe the best mode contemplated by the inventors and therefore may include structure, acts or details of structures and acts that may not be essential to the invention and which are described as examples. Structure and acts described herein are replaceable by equivalents performing the same function, even if the structure. or acts are different, as, known in the art. Therefore,, the scope of the invention is limited only by the elements and limitations as used in the claims.

The present invention provides a biopsy gun (100), useful for obtaining tissue samples. The biopsy gun comprises (a) a biopsy set (700), comprising: vii. a stylet (56), a stylet (56), having a distal end and a proximal end; said distal end comprises a recess; and, viii. a cannula (58);

(b) an engagement mechanism (200), for coupling said biopsy set (700) to said biopsy gun (100);

(c) a two steps cocking mechanism (600), cocking said biopsy set (700);

(d) a firing mechanism (500) for actuating said biopsy set (700);

(e) a sample size adjustment mechanism (900), controlling the stroke length of said biopsy set (700); and,

(f) a safety mechanism (300), for inhibiting undesired firing of said biopsy set (700).

The present invention also provides a method of performing biopsy (800) from a tissue to be sampled. The method comprises inter alia steps selected from: (a) obtaining a biopsy gun (100) having: i. a biopsy set (700), comprising: a. a stylet (56), having a distal end and a proximal end; said distal end comprises a recess; and, b. a cannula (58); ii. an engagement mechanism (200), for coupling said biopsy set (700) to said biopsy gun (100); iii. a two steps cocking mechanism (600), cocking said biopsy set (700); iv. -a firing mechanism (500) for actuating said biopsy set (700); v. a sample size adjustment mechanism (900), controlling the stroke length of said biopsy set (700); and, vi. a safety mechanism (300), for inhibiting undesired firing of said biopsy set (700); (b) engaging said biopsy set (700) into the biopsy gun (100);

(c) first cocking said biopsy gun (100) thereby retracting said cannula (58);

(d) secondary cocking said biopsy gun (100) thereby retracting said stylet (56);

(e) adjusting a stroke length lever (14);

(f) pushing said safety button (20): .thereby enabling the firing of said biopsy gun (100);

(g) introducing said biopsy gun (100) into a body portion to be treated and adjacent to said tissue to be sampled;

(h) activating said firing mechanism thereby firstly actuating said stylet (56); and secondly automatically actuating said cannula (58);

(i) extracting the biopsy gun (100) from said body portion; and,

(j) cocking said biopsy gun (100) thereby obtaining said tissue to be sampled from the stylet

(56) recess.

The term "biopsy gun" refers hereinafter in a non-limiting manner to an automatic biopsy device.

The term "about" refers hereinafter to a range of 25% below or above the referred value.

Figure 1 schematically illustrates a biopsy set (700), comprising a stylet (56) and a cannula (58). The. end of the stylet (56) characterized by having a recess (60) which complies with the length of the desired tissue to be sampled. The cannula (58) coaxially envelopes the stylet (56) and can slide along it. The stylet (56) and the cannula (58) are attached to a stylet engagement member (63) and a cannula engagement member (61) respectively, which are perforated members.

Figure 2 schematically illustrates positioning of the biopsy set (700) into the biopsy gun (100). The hole in the stylet engagement member (63) and the cannula engagement member (61) fit on top of a pin in the cannula slide (10) and the needle slide (11) respectively, with the stylet (56) and cannula (58) perturbing in the frontal aspect of the biopsy gun (100). As needle slide (11) and cannula slide (10) move when the biopsy gun (100) is cocked or fired, they move the cannula engagement member (61) and stylet engagement member (63) with them, thus performing the biopsy action.

Figure 3 schematically illustrates the locking mechanism 1000 of the biopsy gun (100). In other words the figure illustrates the closure of the top cover (30) of the biopsy gun (100) housing after the biopsy gun (100) was loaded with the biopsy set (700). A hook locking member (35) interlocks the top cover (30) into its closing position, securing the safety of the biopsy gun (100) and assuring a smooth operation.

Reference is now made to Figure 4, schematically illustrating the first cocking, which retracts the cannula (58) on the stylet (56) so that the recess (60) on the stylet (56) is exposed. When this action is done after the 700 penetrated the tissue to be biopsied, the tissue is pressed into the recess (60) on the stylet (56), preparing it to be cut. When this action is done after the biopsy set (700) fired and was extracted from the body, the tissue sample tube can be obtained and sent for pathological assessment. As fingers II to V pull the cocking trigger (7) for the first time, a relay mechanism (400), consisting of relay rods 5, 6 and 8 pulls back the cocking slider (1), which in turn pulls back the cannula slide (10) through cannula slide cocking pin (3) and thus the cannula (58). The cocking compresses a slide spring (65) (figure 9), and the cannula slide (10) is kept in place until firing by the cannula pawl (18), which holds a pin extending from the cannula slide (10) (figure 7c). After the first cocking, the cocking bar (2) rotates around its cocking bar axis due to a spring, and abuts the needle slide (11).

Reference is now made to Figure 5, schematically illustrating the second cocking, which retracts the stylet (56) to the same extent as the cannula (58) was retracted. Pulling the cocking trigger (7) pulls back the cocking slider (1), which in turn pulls back the needle slide (11) and the stylet (56), which are kept in place until firing by the needle pawl (17) (figure 7c).

Reference is now made to Figure 6, schematically illustrating the stroke length adjustment. The stroke length lever (14) has three positions, adjusting the travel of the stylet (56) and cannula (58) during the firing sequence, to predetermined lengths of about 15, 20 and 25 mm. as stroke length lever (14) is turned on its axis, it turns the stopper collar (9) and the stopper collar (12), which stop the cannula slide (10) and the needle slide (11) respectively when firing. The different circumferential width of the stopper collar (9) and the stopper collar (12) as opposing the cannula slide (10) and the needle slide (11) in the different stroke length positions of the lever determines how long they will travel until stopped.

Reference is now made to Figure 7, schematically illustrating the safety mechanism. The safety button (20) is connected to a safety shaft (47) (figure 13), which is connected to a relay rod assembly (38, 44, 45), anchored to a safety rod closer (49) at one end. As the safety button (20) is pushed to allow firing, it moves the relay rod assembly in a way which rotates the safety lever pin (40), which, in turn, locks the stroke length lever (14) through the cross bar rear locker (21). This rotation also rotates the safety cam (39), which allows the pawl actuator (24) to actuate the needle pawl (17).

Reference is now made to Figures 8a-8c, schematically illustrating the firing mechanism 500. After double cocking, the biopsy stylet (56) and cannula (58) are inserted adjacent to the tissue to be sampled. Firing the biopsy gun (100) initially ejects the stylet (56), and the tissue to be sampled fills the recess (60) at its distal end. Sequentially the cannula (58) is fired, cutting the tissue compressed in the recess, thus obtaining a tissue core. As the firing trigger (54) is pulled with the index finger, it elevates a beveled member (26), which moves the pawl actuator (24) horizontally. The needle pawl (17) releases the needle slide (11), which was previously cocked, and the slide spring (65) pushes the stylet (56) into the tissue. As needle slide (11) reaches and pushes the stopper collar (12), the cannula pawl (18) is actuated, and releases the previously cocked stopper collar (12). The cannula (58) is ejected into the tissue and cuts the desired tissue core.

Figures 9-12 schematically disclose the assemblies of the various mechanisms: the engagement mechanism (200), the relay mechanism (400), the safety mechanism (300) and the pawl mechanism (500) respectively, and figures 13 and 14 schematically show the final assembly.

It should be pointed out that according to one embodiment of the present invention,- the stylets used in the present invention are obtain from C. R. Bard, Inc or any other company.

According to another embodiment of the present invention, the biopsy gun additionally comprising means for adjusting the recess (60) length of said stylet (56), in a non limiting manner, from a group consisting of about 15mm, about 20mm and about 25 mm.

According to another embodiment of the present invention, the stylet (56) and said cannula (58) are adapted to different gauges.

According to another embodiment of the present invention, the biopsy set (700) is disposable and the gun itself is reusable.

According to another embodiment of the present invention, the safety mechanism (300) is adapted to lock said sample size adjustment mechanism (900).

According to another embodiment of the present invention, the biopsy gun (100) is ergonomic. According to another embodiment of the present invention, the biopsy gun (100) is in a pistol shape.

According to another embodiment of the present invention, a degree of about 100 to about 150 degrees between barrel and handle is provided for better ergonomic configuration.

According to another embodiment of the present invention, the biopsy gun (100) is operable by a single hand.

According to another embodiment of the present invention, the sample size adjustment mechanism (900) comprising means for attuning the stroke length of said biopsy set (700).

According to another embodiment of the present invention, the stroke length of said biopsy set (700) is attuned, in a non limiting manner, from a group consisting of about 15mm, 20mm and 25 mm.

According to another embodiment of the present invention, the sample size adjustment mechanism (900) comprises at least 3 possible positions.

According to another embodiment of the present invention, the cocking mechanism (600) comprises at least two steps.

According to another embodiment of the present invention, the first cocking step retracts said cannula (58); and, said second cocking step retracts said stylet (56).

According to another embodiment of the present invention, the first and second cocking are executed by pulling a cocking trigger (7) twice.

According to another embodiment of the present invention, the firing mechanism comprises a firing trigger such that a single pull of a firing trigger (54) is adapted to actuate said stylet (56), followed by an automatic actuation of said cannula (58).

Reference is now made to Figure 15, disclosing one possible method (800) for performing biopsy, comprising steps of

(a) obtaining a biopsy gun (100) and a biopsy set (700) (denotes as step 810);

(b) engaging the biopsy set (700) into the biopsy gun (100) (denotes as step 820);

(c) cocking twice the biopsy gun (100) (denotes as step 830); the step of cocking the biopsy gun (100) comprises two stages: (i) first cocking said biopsy gun (100) thereby retracting said cannula (58); and, (ii) secondary cocking said biopsy gun (100) thereby retracting said stylet (56);

(d) adjusting the stroke length.lever (14) (denotes as step 840); (e) pushing the safety button (20) (denotes as step 850); thereby enabling the firing of said biopsy gun (100);

(f) Inserting the biopsy gun (100) near the tissue to be sampled (denotes as step 860);

(g) activating said firing mechanism thereby firstly actuating said stylet (56); and secondly automatically actuating said cannula (58); (denotes, as step.870);

(h) extracting the biopsy gun (100) from the tissue (denotes as step 880); and, (i) Cocking once and obtaining the tissue from the stylet (56) recess (60) (denotes as step 890).

For example, in a non limiting manner, when performing prostatic biopsy, the first step is~{as always) TRUS with measurements of the prostatic size. The operator will then refer to the diameter "a" in Fig. 16. The operator will choose the appropriate needle size that shall be 5- 10 mm smaller than diameter "a". Three stroke lengths will be available: 15mm, 20mm and 25mm . In larger prostates instead of taking more cores, stylets with longer recess (60) will be used. Longer cores of tissue will be available for pathological examination. The expected result will be better sampling of the prostate without the need for additional needle insertions. The ergonomically-built, single handed two-spring, biopsy gun (100) will be held by the right palm of the operator against a stable 4 finger grip. The grip is also used to cock the slide springs (65). The firing trigger (54) and the safety button (20) are apposing the index and thumb of the right hand respectively. A thumb-operated stroke length lever (14) is used to adjust needle stroke-length. The top cover (30) of the gun is opened and the stylet (56) and cannula (58) are inserted in place. The biopsy gun (100) has a two-stroke cocking mechanism operated with 4 fingers. In the first step, the inner part of the stylet (56) is exposed and in the second step it is covered by the cannula (58).

The operator advances the stylet (56) into the tissue to the desired place. The operator then releases the safety button (20) with his thumb, and then, with the index finger, he pulls. the firing trigger (54) that activates the slide spring mechanism. Once activated, the needle slide spring (65) shoots the stylet (56) forward, momentarily later, the cannula (58) advances, cutting a core of tissue.

The stylet (56) is removed, and using the cocking mechanism (600) (one stroke), the recess (60) of the stylet (56) is exposed and the tissue core retrieved. After another stroke of the cocking mechanism (600) the biopsy gun (100) is ready for the next biopsy. The prostatic dimensions are "a" the AP diameter, "b" the lateral diameter, "c" the cranio- caudal dimension. The transitional zone is depicted in gray, surrounded by the peripheral zone. A biopsy needle (56) is inserted into the peripheral zone.

The proposed biopsy gun (100) is ergonomically built with a convenient 120 angle between the handle and the needle. The firing trigger (54) and the safety button (20) face the operator's index and thumb. Cocking of the springs is done by the strong flexor muscles of the forearm. In contrary, in current instruments, where the trigger is facing the palm of the operator, a difficult maneuver must be performed in order to use it. Cocking of current biopsy guns requires two hands and is very inconvenient to the operator who must give the ultrasonic probe to an assistance.

According to another embodiment of the present invention, the method as described above additionally comprising step of attuning the length of said recess (60) to values selected from a group consisting of about 15mm, about 20mm and about 25 mm.

According to another embodiment of the present invention,'the method as described above additionally comprising step of attuning said stylet (56) and said cannula (58) to different gauges.

According to another embodiment of the present invention,^' the method as described above additionally comprising step of locking said sample size adjustment mechanism (900) via said safety mechanism (300).

According to another embodiment of the present invention, the biopsy gun (100) is ergonomic.

According to another embodiment of the present invention, the method as described above additionally comprising step of selecting the shape of said biopsy gun (100) from a pistol shape.

According to another embodiment of the present invention, the method as described above additionally comprising step of attuning the stroke length of said biopsy set (700). According to another embodiment of the present invention, the method as described above additionally comprising step of selecting said stroke length of said biopsy set (700), in a non limiting manner, from a group consisting of about 15mm, 20mm and 25 mm.

Reference is now made to figure 17 which is a true image of the biopsy gun 100 as describe in the present invention. As can be seen from the figure, the biopsy gun 100 is very ergonomic and can be held via a single hand (denotes as 17).

In the foregoing description, embodiments of the invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments were chosen and described to provide the best illustration of the principals of the invention and its practical application, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.

Examples

Examples are given in order to prove the embodiments claimed in the present invention. The example, which is a clinical test, describes the manner and process of the present invention and set forth the best mode contemplated by the inventors for carrying out the invention, but are not to be construed as limiting the invention.

EXAMPLE 1

A biopsy taken from a dog's prostate.

Reference is now made to Figure 18, which compares core biopsies taken with Tru-cut biopsy system and with the present invention. The two images on the right are microscopic images of a core biopsy taken from a dog prostate with a Tru-cut needle (Baxter Laboratory, Morton Grove, IL), while the two images on the left represent microscopic images of the same magnification of core biopsy taken from a dog's prostate using the present invention. It is evident that the tissue sample of the present invention is at least as thick, if not thicker than the other tissue sample. The cells are preserved, as can be seen from the XlOO magnification. EXAMPLE 2

A biopsy taken from a chicken's liver

Reference is now made to Figure 19, which compares core biopsies taken with Tru-cut biopsy system and with the present invention. The two images on the right are microscopic images of a core biopsy taken from a dog prostate with a Tru-cut needle {Baxter Laboratory, Morton Grove, IL), while the two images on the left represent microscopic images of the same magnification of core biopsy taken from a chicken's liver using the present invention. It is evident that the tissue sample of the present invention is at least as thick, if not thicker than the other tissue sample. The cells are preserved, as can be seen from the XlOO magnification.

Claims

1. A biopsy gun (100), useful for obtaining tissue samples, wherein said biopsy gun comprising: a. a biopsy set (700), comprising: i, a stylet (56), a stylet (56), having a distal end and a proximal .end; said distal end comprises a recess (60); and, ii. a cannula (58); b. an engagement mechanism (200), for coupling said biopsy set (700) to said biopsy gun (100); c. a two steps cocking mechanism (600), in communication with said biopsy set (700), for doubly cocking said biopsy set (700); d. a firing mechanism (500) in communication with said biopsy set (700) and with said cocking mechanism (600), for actuating said biopsy set (700); e. a sample-size adjustment mechanism (900); and, f. a safety mechanism (300), for inhibiting undesired firing of said biopsy set (700); wherein the stroke length of said biopsy set (700) is controlled via said sample size adjustment mechanism (900).

2. The biopsy gun (100) according to claim 1, wherein said biopsy gun additionally comprising means for adjusting the recess (60) length of said stylet (56), in a non limiting manner, from a group consisting of- about 15mm, about 20mm and about 25 mm.

3. The biopsy gun (100) according to claim 1, wherein said stylet (56) and said cannula (58) are adapted to different gauges.

4. The biopsy gun (100) according to claim 1, wherein said biopsy set (700) is disposable and the gun itself is reusable.

5. The safety mechanism (300) according to claim 1, wherein said safety mechanism (300) is adapted to lock said sample size adjustment mechanism (900).

6. The biopsy gun (100) according to claim 1, wherein said biopsy gun (100) is ergonomic.

7. The biopsy gun (100) according to claim 6, wherein the shape of said biopsy gun (100) is in a pistol shape.

8. The biopsy gun (100) according to claim 7, wherein a degree of about 100 to about 150 degrees between barrel and handle is provided for better ergonomic configuration.

9. The biopsy gun (100) according to claim 1, wherein said biopsy gun (100) is operable by a single hand.

10. The biopsy gun (100) according to claim 1, wherein said sample size adjustment mechanism (900) comprising means for attuning the stroke length of said biopsy set (700).

11. The biopsy gun (100) according to claim 10, wherein said stroke length of said biopsy set (700) is attuned, in a non limiting manner, from a group consisting of about 15mm, 20mm and 25 mm.

12. The biopsy gun (100) according to claim 1, wherein said sample size adjustment mechanism (900) comprises at least 3 possible positions.

13. The biopsy gun (100) according to claim 1, wherein said cocking mechanism (600) comprises at least two steps.

14. The biopsy gun (100) according to claim 13, wherein said first cocking step retracts said cannula (58); and, said second cocking step retracts said stylet (56).

15. The biopsy gun (100) according to either one of claims 1-14, wherein said first and second cocking are executed by pulling a cocking trigger (7) twice.

16. The biopsy gun (100) according to claim 1, wherein said firing mechanism comprises a firing trigger such that a single pull of a firing trigger (54) is adapted to actuate said stylet (56), followed by an automatic actuation of said cannula (58).

17. A method of performing biopsy (800) from a tissue to be sampled, comprising steps of: a. obtaining a biopsy gun (100) having: i. a biopsy set (700), comprising: a. a stylet (56), having a distal end and a proximal end; said distal end comprises a recess (60); and, b. a cannula (58); ii. an engagement mechanism (200), for coupling said biopsy set (700) to said biopsy gun (100); iii. a two steps cocking mechanism (600), cocking said biopsy set (700); iv. a firing mechanism (500) for actuating said biopsy set (700); v. a sample size adjustment mechanism (900), controlling the stroke length of said biopsy set (700); and, vi. a safety mechanism (300), for inhibiting undesired firing of said biopsy set

(700); b. engaging said biopsy set (700) into the biopsy gun (100); c. first cocking said biopsy gun (100) thereby retracting said cannula (58); d. secondary cocking said biopsy gun (100) thereby retracting said stylet (56); e . adj usting a stroke length lever (14); f. pushing said safety button (20); thereby enabling the firing of said biopsy gun (100); g. introducing said biopsy gun (100) into a body portion to be treated and adjacent to said tissue to be sampled; h. activating said firing mechanism thereby firstly actuating said stylet (56); and secondly automatically actuating said cannula (58); i. extracting the biopsy gun (100) from said body portion; and, j. cocking said biopsy gun (100) thereby obtaining said tissue to be sampled from the stylet (56) recess.

18. The method according to claim 17, additionally comprising step of attuning the length of said recess (60) to values selected from a group consisting of about 15mm, about 20mm and about 25 mm.

19. The method according to claim 17, additionally comprising step of attuning said stylet (56) and said cannula (58) to different gauges.

20. The method according to claim 17, wherein said biopsy set (700) is disposable and.the gun itself is reusable.

21. The method according to claim 17, additionally comprising step of locking said sample size adjustment mechanism (900) via said safety mechanism (300).

22. The method according to claim 17, wherein said biopsy gun (100) is ergonomic.

23. The method according to claim 17, additionally comprising step of selecting the shape of said biopsy gun (100) from a pistol shape.

24. The method according to claim 17, wherein said biopsy gun (100) is operable by a single hand.

25. The method according to claim 17, additionally comprising step of attuning the stroke length of said biopsy set (700).

26. The method according to claim 25, additionally comprising step of selecting said stroke length of said biopsy set (700), in a non limiting manner, from a group consisting of about 15mm, 20mm and 25 mm.