RU94836U1 - DEVICE FOR TRANSRECTAL BIOPSY - Google Patents

Abstract

 A device for transrectal biopsy containing a housing, a pistol grip, a drive equipped with a cocking mechanism, a trigger, a safety lock and a removable working element located in the housing, characterized in that the removable working element is made in the form of a cartridge with the possibility of stepwise movement perpendicular to the longitudinal axis of the housing, consisting of two halves connected by a lock loop, with half cylinders at the proximal end of the lower inner half of the cassette with a through slot in the vertical diameter swivel plane and feed tubes with return springs inside at the distal end of the latter, an aiming plate with an adjustment screw is installed on the lower distal surface of the housing.

Description

The utility model relates to medical equipment, namely to the diagnosis of diseases of the prostate gland (pancreas) by transrectal fine-needle biopsy, in particular, through the perineum or rectum under the control of external ultrasound radiation (ultrasound) or rectal emitter of transrectal ultrasound (TRUS) under local anesthesia .

Improving the efficiency of diagnosis of pancreatic diseases according to various biopsy schemes, which is one of the stages for diagnosing prostate cancer, depends not so much on the number of biopsy columns of the main prostate tissue, recognized as necessary and sufficient when creating an expert automated system for diagnosing benign and malignant tumors of the patient’s pancreas [K. Fedosenko AT. et al. Expert automated diagnostic system for benign and malignant neoplasms of the endometrium and prostate gland. Manual for doctors, ed. G. B. Kovalsky. - St. Petersburg, 2000. - S.16-22], how much from the place of taking additional peripheral pancreatic fragments, characterizing the severity of the disease [Pushkar D.Yu. et al. Diagnostic capabilities of a prostate biopsy. Urology, 2002, No. 6. - S. 47]. To reduce the unpleasant sensations of patients in the diagnosis of pancreatic diseases by transrectal biopsy in the rectum, the preference is given to the design of devices for simultaneous automated sampling of biopsy material under ultrasound imaging with adjustment of the location of the echogenic tip of the needle in the area of the pancreatic puncture in the absence of needle bias at the time of tissue collection [ Diseases of the prostate gland. / Ed. Yu.G. Alyaeva. - M. GEOTAR - Media, 2009, - S. 39-43].

An automatic reuse system for biopsy PRO-MAG 2.5 was chosen as an analogue [NAYFELD Corporation, 3255 Liberty ave., Alameda, CA94501 USA, www.MEDFORUM.ru, Operating Instructions. - M., 2004, - C.1-2], designed to obtain tissue samples during histological studies. The biopsy system consists of a tool body with a cover, special grooves of the holder inside the biopsy system body, in which a biopsy needle is placed, a multidisciplinary automatic control handle - activation of a tool safety system, a platoon of a spring mechanism - a safety button, a start button that controls the operation of the spring trigger.

The disadvantages of the design of the analogue include the manual method of removing the needle of the instrument from the patient’s body after a biopsy, associated with the possibility of additional trauma; the need for the clinician to correct the position of the pancreatic biopsy device relative to the axis of the TRUS transducer during subsequent sampling of tissue samples to adequately detect pancreatic cancer (opening the lid of the instrument body, changing the needle in the grooves of the holder), selecting the subsequent endpoint for positioning the echogenic needle tip; an increase in the time for performing manipulations on the collection of a transrectal targeted biopsy due to the repeated change of needles, which leads to the appearance of unpleasant sensations in the patient in the rectum.

As a prototype, a biopsy device was selected [patent RU No. 2188581 А61В 10/00, 17/34], used for sampling kidney and pancreas tissues and containing an elongated body with an end fitting, a pistol grip, a drive, a replaceable working element placed in the body in the form of a movable needle with an end thickening, and the end installation means is made in the form of a thrust surface of an elongated body having a box-shaped shape; the drive is equipped with a cocking mechanism, a trigger and a fuse; the movable needle is installed with the possibility of interaction (via kinematic connection) with the drive and is located with an offset from the longitudinal axis of the body of at least 1/4 of half the maximum size of the thrust surface.

The disadvantages of the design of the prototype include:

- the need for the clinician to correct the position of the pancreatic biopsy device relative to the axis of the TRUS transducer when re-taking tissue samples necessary for adequate detection of pancreatic cancer (changing the moving needle on the body), choosing the subsequent endpoint for the positioning of the echogenic needle tip, and, as a result, increasing ergonomics devices

- an increase in the time for performing manipulations on the selection of biopsy samples due to the repeated change of moving needles on the body, which leads to unpleasant sensations of the patient in the rectum;

- the impossibility of sharing the end installation means, made in the form of a persistent surface of an elongated case with a box-shaped shape, with a TRUSI emitter when automating the selection of pancreatic biopsy specimen due to a shift of the input axis of the movable needle from the longitudinal axis of the aiming plate on the body at least 1/4 of half the maximum size of the thrust surface.

We first proposed a device for a transrectal biopsy, which contains a body that has a through horizontal slot in the distal part on the side surfaces for installing a cassette with interchangeable working elements (biopsy needles) that pass sequentially through the reticle mounted on the TRUSI emitter using the adjustment screw, with the help of which the path is adjusted between the injection point and the endpoint of the positioning of the echogenic needle tip on the ultrasound of the pancreas according to SRI aiming. The cartridge consists of two halves with 6 half-cylinders for biopsy needles in the lower half, connected by a lock (loop) with 4 guides located on the outer surface of the cartridge perpendicular to the direction of the longitudinal axes of the half-cylinders, to ensure the direction of movement of the cartridge inside the device, the lower the guide on the proximal side of the cartridge is made with slots for stepwise movement of the cartridge with discreteness of the distance between the centers of the longitudinal axes of the half-cylinders. In the wall of the semi-cylinders of the lower part of the cassette there are through slotted slots in the vertical diametrical plane for the safety bars of the biopsy needles. In the distal part of the lower half of the cassette, needle feed tubes are installed, inside of which are placed the springs for returning the needles to the half-cylinders after biopsy. For cleaning and lubricating the drive of the device, the upper housing cover is used.

After removing the fuse, turning on the drive’s cocking button and pressing the trigger, the interchangeable working element — the biopsy needle, under the influence of the drive — moves along the axial line of the device’s body through the aiming bar and is inserted into the prostate gland through the rectal area of the patient to select a prostate biopsy from 6 points (the so-called “sextant” biopsy), in which prostate tissue samples are taken along the parasagittal line between the middle groove and the lateral border of the prostate from the base, middle part and the tops of the right and left lobes [DY Pushkar et al. Diagnostic capabilities of a prostate biopsy. Urology, 2002, No. 6. - S.47], in the sequence of the order of placement of needles in the cassette.

The proposed device is shown in Fig 1, where:

1 - pistol grip;

2 - descent;

3 - cock button;

4 - fuse button (cartridge movement);

5 - upper housing cover;

6 - the device body;

7 - aiming strip;

8 - adjustment screw;

9 - replaceable working element (needle for biopsy);

10 - cassette with needles for biopsy.

The device consists of a housing (6) with a pistol grip (1) with a release (2), the upper housing cover (5), a cocking button (3) and a fuse (cartridge movement) (4). Using the adjustment screw (8) of the aiming strip (7), the housing (6) of the device is mounted on the TRUSI emitter. In the distal part, the housing (6) has a through horizontal slot on the side surfaces for installing the cassette (10) with biopsy needles (9). The cartridge (10) is shown in figure 2, where:

11 - the upper half of the cartridge;

12 - guide;

13 - lock loop;

14 - the lower half of the cartridge;

15 - lower guide with slots;

16 - a half cylinder;

consists of two halves - the upper (11) and lower (14), connected by a lock loop (13) with guides (12), and the lower guide (15) on the proximal side of the cartridge (10) is made with slots for moving it stepwise with discreteness of magnitude the distance between the centers of the longitudinal axes of the semicylinders (16) in which the biopsy needles are placed (9). On the distal side of the cassette (10) there are feed tubes (17) according to the number of biopsy needles (9) (Figure 3), where:

17 - feed tube;

18 - return spring;

inside which the return springs (18) of the biopsy needles (9) are placed in the half-cylinders (16) of the cartridge (10) after the biopsy is taken.

The device operates as follows. To obtain tissue samples of the prostate gland by transrectal biopsy, the device body (6) is held by the pistol grip (1) and after moving the safety button (4) to the lower position, insert the cartridge (10) with biopsy needles (9) into the through horizontal a slot on the right side surface of the housing (6), and the fuse button (4) and the cocking button (3) are triggered (rise to the upper position).

The housing (6) of the device is mounted on the rectal emitter using the adjustment screw (8) of the aiming strip (7). After pressing down the safety button (4), the needle No. 1 is inserted into the reticle (7) of the rectal emitter, the aiming path of the needle is precisely aligned (one-to-one correspondence between the injection point and the final positioning point of the echogenic tip of needle No. 1 on the ultrasonogram of the prostate gland). By pressing the platoon button (3) - down - the last one is brought into the working position, which allows, after pressing the trigger (2), to accelerate the passage of the biopsy needle No. 1 (9) through the prostate tissue to the intended positioning site, select the biopsy specimen and return the No. 1 needle to the half cylinder (16) cassettes (10). To select the following biopsy samples, a similar operation is performed with needles No. 2, 3, etc. After the biopsy sample is taken with the last needle No. 6 and returned to the cartridge half-cylinder (16) (10), the device body (6) is held by the pistol grip (1) to remove the cartridge (10) from the through horizontal slot on the left side surface of the case (6). . Cleaning and lubricating the elements of the drive mechanism inside the housing (6) of the device is carried out with the cover open (5).

The proposed design eliminates the disadvantages of the prototype, since it implements the joint use of a transrectal biopsy device with a TRUSI emitter for automation of the pancreatic biopsy selection process, allows you to establish a correspondence between the injection point and the end position of the echogenic tip of the needle on the pancreas ultrasonogram until the accelerated passage of the biopsy needle through the prostate tissue to the intended positioning position; allows the clinician to adjust the position of the pancreatic biopsy device relative to the axis of the TRUS transducer with the optimal number of tissue samples necessary for adequate detection of pancreatic cancer, to increase the ergonomics of the device; to carry out automated sampling of prostate tissue during atraumatic insertion and extraction of removable working elements of the device; to simplify the aiming process, to ensure the speed of the operation with the sequential introduction of several needles and the absence of displacement of the latter at the time of biopsy sampling to increase the stability of sampling with a “sextant” biopsy and productivity with repeated use of the removable working element of the device after sterilization, to exclude manual operations with biopsy needles. An additional convenience is the preservation of the material of all standard sextant biopsies taken in 6 numbered elements of the device until the end of the operation, eliminating the possibility of error in the sample number and place of sampling, reducing various kinds of unpleasant sensations of the patient in the rectum, reducing the time of one procedure by 30%.

Claims (1)

A device for transrectal biopsy containing a housing, a pistol grip, a drive equipped with a cocking mechanism, a trigger, a safety lock and a removable working element located in the housing, characterized in that the removable working element is made in the form of a cartridge with the possibility of stepwise movement perpendicular to the longitudinal axis of the housing, consisting of two halves connected by a lock loop, with half cylinders at the proximal end of the lower inner half of the cassette with a through slot in the vertical diameter swivel plane and feed tubes with return springs inside at the distal end of the latter, the aiming plate with the adjustment screw is installed on the lower distal surface of the housing.