RU231567U1 - Endoscopic device for fine needle aspiration biopsy - Google Patents

Abstract

The utility model generally relates to diagnostic instruments, and more specifically to fine-needle biopsy instruments, together with an ultrasonic endoscope. The endoscopic fine-needle aspiration device is aimed at increasing the ease of use due to the ergonomic handle and the formation of tactile structures on the handle surface with characteristic geometric parameters. The design of the device consists directly of an aspiration needle for taking samples, which is inserted into a housing in the form of a telescopic handle with a handle. The device contains drive mechanisms equipped with scales. The scales are used to adjust the depth of penetration of the aspiration needle into the target area and fix the selected position of the needle using a locking mechanism. This ensures accurate sampling of the target tissue. An aspiration syringe is installed at the proximal end of the handle. At the distal end, the telescopic handle is attached to the endoscope connector. The handle has an ergonomic elliptical shape and an elongated conical distal part with an increase in diameter at the end, wherein half of the distal surface of the handle is made in the form of a tactile structure consisting of a system of radial depressions in the form of an angle, 83° in size and 2 mm in depth, and in the narrow part of the handle spaced from each other with a constant pitch of 1.4 mm, and then in the proximal direction - with a variable pitch of 2.5 mm to 4.5 mm, while longitudinal grooves are made on the formed relief surface, located around the surface through an angle of 45°, a similar tactile structure is made on the saddle-shaped surface of the second sliding handle.

Description

The utility model generally relates to diagnostic instruments, and more specifically to fine-needle biopsy instruments, together with an ultrasound endoscope.

Fine needle biopsy was developed specifically to increase the reliability of diagnostics and improve the quality of medical care for patients.

The endoscopic fine needle aspiration device (hereinafter referred to as the device) includes a fine aspiration needle for taking tissue samples. The device can be easily and safely connected to the working biopsy channel of the endoscope and to the aspiration syringe.

The endoscope contains an ultrasound sensor and a camera in its distal part, and special surface treatment of the aspiration needle ensures its echogenicity and visibility of the needle on the ultrasound screen during the medical procedure. The biopsy is performed under image control, which helps the doctor direct the needle and control the position of its tip.

The prior art includes endoscopic fine-needle aspiration devices which, for ease of use with other medical devices, are made in the form of a telescopic handle with a grip.

Considering that the hand has a high ability to adapt to performing various manipulation tasks and working with objects that require high precision, an ergonomic, comfortable shape of the handle and tactile sensitivity of its surface are required. The formation of a tactile structure facilitates working with the handle. The greatest acuity of tactile sensitivity and, accordingly, its lowest thresholds occur on the distal parts of the body, such as the fingertips, which most actively perform motor functions.

The patent documents US 2018008127 - "Endoscopic ultrasonic fine needle aspiration device", US20120289901 - "Medical handpiece", US 6976955 - "Handle for medical devices and assemblies of medical devices including a handle" describe telescopic devices comprising an elongated body having a proximal part, a central part and a distal part.

The use of the term "distal" herein refers to the direction away from the user and toward the area of action on the patient's tissue, and the term "proximal" refers to the direction toward the user of the device (e.g., a physician), with the proximal portion of the device remaining external to the patient as the endoscope attached to the distal portion is inserted into the body.

Inside the housing, in the through axial channel of the housing, there are tubular overlapping sliding elements equipped with scales and the ability to adjust the magnitude of their movement in the longitudinal direction. The scales are used to adjust the depth of penetration of the aspiration needle into the target area and select its position using fixing elements. This ensures accurate sampling of the target tissue into the lumen of the needle.

The handle is connected to an adjustment part that controls the proximal-distal movement of an aspiration needle inserted through the device into an endoscope attached to the distal part of the device.

Most of the manipulations are performed by the physician manually using the handle, performing the following operations: preparing the needle for the procedure, inserting the endoscopic needle into the endoscope, advancing the needle, gently withdrawing/retracting the needle into the biopsy site to ensure that the sample is taken as required, ensuring the integrity of the sample for biopsy diagnosis, fully extending the handle to remove the needle from the target tissue after aspiration.

The most important requirement for the handle is its comfortable position in the hand for easy, accurate biopsy, so the handle should be ergonomic, comfortable with a good grip for the hand and ease of manipulation.

In US 2018008127, the proximal portion of the handle further comprises a smooth groove formed near its distal end to facilitate gripping and manipulation thereof.

In application US 2012289901, taken as a prototype, the proximal part of the handle and the central part of the handle are made with longitudinal grooves and notches between them.

In patent US 6976955, the proximal part of the handle for ease of use is made in its distal part with a thickening by increasing the diameter, compared to its other part, to form a resting position area for the user's finger. At the same time, an insert with notches is fixed on the surface of the handle to improve grip. The grip insert can be made of the same material as the handle, such as plastic, or it can contain another material, such as rubber or another polymeric material.

However, the known handles have a textured surface that is insufficient for tight contact with the fingers, worsening the grip, and at the same time have insufficient tactile sensitivity, which worsens the accuracy of movement of the handle with the needle and reduces the ease of use of the device.

The technical task that the utility model is aimed at solving is to increase the ease of use of the device due to the ergonomic shape of the handle for the fingers of the hand, and the geometric parameters of the tactile structure of the surface of the handle.

The specified technical result, when implementing the utility model, is achieved due to the fact that the endoscopic fine-needle aspiration device, made in the form of a telescopic handle, consisting of three parts: a proximal part in the form of a proximal handle, equipped with a lock and an opening for inserting an aspiration needle and connecting with other medical instruments, a central part in the form of a sliding handle with a lock and a distal part with a lock for connecting to an endoscope, wherein the device is made with a through central channel in which an aspiration needle and two tubular overlapping sliding elements are located, equipped with scales, with the possibility of adjusting and fixing the amount of their movement in the longitudinal direction, wherein the proximal handle is connected to the adjustment part controlling the proximal-distal movement of the aspiration needle, and the scales are used to adjust and fix the position of the aspiration needle and the depth of its penetration into the target area, wherein, according to the utility model, the proximal the handle has an elliptical shape, smoothly turning into an elongated conical distal part with an increased diameter at the end, wherein half of the surface of the distal part of the proximal handle is made in the form of a tactile structure consisting of a system of radial depressions in the form of an angle of 83°, 2 mm deep, with a constant pitch of 1.4 mm, and then in the proximal direction with a variable pitch from 2.5 mm to 4.5 mm, while longitudinal grooves are made on top of the surface with the tactile structure, located around the surface at an angle of 45°, a similar tactile structure is made on the saddle-shaped surface of the sliding handle, wherein in the central part radial depressions are made 2 mm deep, in the form of an angle of 83°, spaced from each other with a constant pitch of 1.4 mm, and along the edges of the surface of the sliding handle - with a variable pitch of 2.5 mm to 4.5 mm, longitudinal grooves are evenly spaced around the surface at an angle of 45°.

In order for the main proximal handle to lie better in the hand, its gripping surface has an elliptical shape. The smooth transition of the elliptical surface into a conical one is an extension of the gripping surface for the fingers, so that the entire hand is tangent to all parts of the gripping surface, which achieves a comfortable positioning of the handle in the hand and, therefore, ease of use of the device. A tighter contact with the hand and good fixation increases the accuracy of movement of the handle and the associated instrument - the needle itself.

When performing their actions, the user is always guided by tactile feedback, seeing the object on the monitor.

To improve the tactile sensitivity of the fingers, a tactile structure consisting of small protrusions, the geometric dimensions of which are additionally significant features that increase the ease of use of the device, has been added to the surface of the handle.

The geometric parameters of the tactile structure, consisting of a system of radial depressions in the shape of an angle, 83° in size, 2 mm deep, with a constant pitch of 1.4 mm, and then in the proximal direction with a variable pitch from 2.5 mm to 4.5, are selected in such a way that a longitudinal depression for the fingers with an emphasis and with tactile protrusions under the fingertips is formed on the entire conical surface.

And the radial depressions in the form of an angle of 83° form acute-angled protrusions, and due to the variable pitch they increase in height and change to protrusions with a flat surface. Thus, the entire conical surface is effectively used to create the necessary sensation with minimal pressure on the fingers and additionally facilitates the process of using the device. Changing the geometric parameters and minimum pitch values to a smaller side will lead to the fact that the surface will be smoothed out, tactile sensitivity and fixation and grip will deteriorate, as a result, the convenience of controlling the device will deteriorate. If the geometric parameters and maximum pitch values are chosen greater than those specified, then the shapes of the tactile design will be disproportionate to this conical surface and the handle will not be able to perform its function conveniently.

Longitudinal grooves, made on top of the tactile structure and located around the surface at an angle of 45°, are used to provide ventilation and collect polluting particles.

The utility model is illustrated by the example of implementation given below and the figures of the drawings, which show:

Fig. 1 - General view of the endoscopic fine-needle aspiration device.

Fig. 2 - View of the endoscopic fine-needle aspiration device in working condition.

Fig. 3 - General view of the proximal handle with the tactile structure of the distal surface.

Fig. 4 - Cross-section A-A of the proximal handle of Fig. 3.

Fig. 5 - View B of the tactile structure in Fig. 3, enlarged.

Fig. 6 - View B of the radial depression of the tactile structure in Fig. 5 in the form of an angle, enlarged.

Fig. 7 - General view of a sliding handle with a tactile structure in the form of a system of radial depressions and axial grooves.

Fig. 8 - Cross-section G-G of the sliding handle in the area of the tactile structure of the surface.

Fig. 9 - View D of the sliding handle in Fig. 7, enlarged.

Fig. 10 - View E of the radial depression in the form of an angle in Fig. 9, enlarged.

The endoscopic fine-needle aspiration device (Fig. 1) is made in the form of a telescopic handle consisting of a proximal part of the device in the form of a handle 1 with an opening 2 for inserting an aspiration needle 3, as well as for connecting with medical instruments, such as a syringe, etc. The handle 1 is provided with a lock 4. The central part of the handle consists of a sliding handle 5 with a lock 6. The distal part of the telescopic handle is provided with a lock 7 for connecting with an endoscope. The device is made with a through central channel in which an aspiration needle 3 and tubular overlapping sliding elements are located, provided with scales 8 and 9 (Fig. 2) with the possibility of adjusting the amount of their movement in the longitudinal direction and fixing the selected position with locks 4 and 6, respectively. In the device, the tubular sliding element 8 is a holder of the aspiration needle 3. The handle 1 is connected to the adjustment part, which controls the proximal-distal movement of the aspiration needle 3. The shell 12, surrounding the medical hollow aspiration needle 3, is connected to the second sliding part 9, and the sliding handle 5 controls its movement. The scales 8 and 9 are used to adjust and fix the depth of penetration of the aspiration needle 3 into the target area.

The handle 1 has an elliptical shape and an elongated conical distal part for improving the grip by the hand and the position of the fingers. On the conical distal surface of the handle 1, a tactile structure is made in the form of a system of radial depressions 2 mm deep in the form of an angle of 83°, spaced from each other at first by a constant step (designated as a "step" in Fig. 5) equal to 1.4 mm, and then, towards the proximal part, the radial depressions are made with a variable step of 2.5 mm to 4.5 mm. On the formed relief surface, longitudinal grooves 10 are made (Figs. 3 and 4), located evenly around the relief surface at an angle of 45°. A similar system of shaping the tactile structure is made on the entire saddle-shaped surface of the sliding handle 5 (Figs. 7, 9 and 10). In the central part of the surface 5 there are radial depressions 2 mm deep, in the form of an angle of 83°, spaced from each other at a constant pitch of 1.4 mm, and along the edges of the surface a variable pitch of 2.5 mm to 4.5 mm is used. On the formed relief surface there are longitudinal grooves 11 (Figs. 7 and 8), located evenly around the relief surface at an angle of 45°.

The handles are injection molded from a copolymer of acrylonitrile butadiene and styrene, acrylonitrile butadiene styrene (ABS). This material is hard, scratch-resistant, and has good dimensional stability.

To obtain cytological/histological material, the device is inserted into the biopsy channel of the ultrasound endoscope. The ultrasound endoscope is positioned opposite the designated area, and then, using the aspiration needle 3, the doctor penetrates it through the organ wall into the designated puncture area. With a back-and-forth or proximal-distal movement of the hand, holding the handle 1, the doctor makes so-called passes, which ensures that tissue samples enter the lumen of the needle. Due to the presence of echogenic marks on the tip of the needle, the position of the aspiration needle 3 can be controlled using ultrasound on the screen of the ultrasound device.

An aspiration needle for ultrasound endoscopes or an endoscopic ultrasound fine-needle aspiration device, made in the form of a telescopic handle, allows doctors to perform a wide range of procedures, minimizing patient trauma. During operation, the sliding handle 5 controls the protective sheath of the needle 12. Using the handle 1, the doctor must perform a number of manipulations: withdraw/retract the needle 3 into the biopsy site by applying sufficient proximally or distally directed force to the proximal end of the needle to ensure accurate sampling.

Thus, as can be seen from the example of implementation, the claimed utility model is an improved design of an endoscopic fine-needle aspiration device. The use of the utility model solves the technical problem of increasing the ease of use of the device.

The ergonomic design of the handle in the form of an ellipse with an elongated conical distal part facilitates control of the device, providing comfort for grip, tighter contact with the hand, good fixation, reliable retention during control and, therefore, increased ease of use of the device.

To improve the tactile sensitivity of the fingers, a tactile structure consisting of projections of different heights and shapes is added to the surface of the handle, the geometric parameters of which are additionally significant features that increase the convenience of using the device. Thus, the entire conical surface of the handle is effectively used to create a tactile feeling with minimal pressure on the fingers, which facilitates the process of using the device.

As a result of solving the technical problem with the utility model - increasing the ease of use of the device - leads to a better tactile perception of the needle as a whole, and can be an addition to increasing the reliability of diagnostics - the main task of fine-needle biopsy.

Claims (1)

An endoscopic device for fine-needle aspiration biopsy (hereinafter referred to as the device), made in the form of a telescopic handle consisting of three parts: a proximal part in the form of a proximal handle equipped with a lock and an opening for inserting an aspiration needle and for connecting to a syringe, a central part in the form of a sliding handle with a lock and a distal part with a lock for connecting to an endoscope, the device is made with a through central channel in which an aspiration needle and two tubular overlapping sliding elements equipped with scales are located, with the possibility of adjusting and fixing the amount of their movement in the longitudinal direction, wherein the handle is connected to an adjustment part controlling the proximal-distal movement, and the scales are used to adjust and fix the position of the aspiration needle and the depth of its penetration into the target area, characterized in that the proximal handle has an elliptical shape and an elongated conical distal part with an increase in diameter at the end, wherein half of the distal surface of the handle is made in the form of a tactile structure consisting of radial depressions in the form of an angle of 83° and a depth of 2 mm, and in the narrow part of the handle, spaced from each other with a constant pitch of 1.4 mm, and then in the proximal direction - with a variable pitch of 2.5 mm to 4.5 mm, while longitudinal grooves are made on the formed relief surface, located around the surface through an angle of 45°, a similar tactile structure is made on the saddle-shaped surface of the sliding handle, in the central part of the surface - radial depressions with a depth of 2 mm, in the form of an angle of 83°, spaced from each other with a constant pitch of 1.4 mm and with a variable pitch of 2.5 mm to 4.5 mm along the edges of the surface of the sliding handle, longitudinal grooves are made on the formed relief surface, located evenly around the surface through an angle equal to 45°.