WO2017130169A1

WO2017130169A1 - Device for taking samples of biological tissue

Info

Publication number: WO2017130169A1
Application number: PCT/IB2017/050484
Authority: WO
Inventors: Vincenzo CENNAMO
Original assignee: Cennamo Vincenzo
Priority date: 2016-01-29
Filing date: 2017-01-30
Publication date: 2017-08-03
Also published as: ITUB20160337A1

Abstract

The invention concerns a device (1) for taking samples of biological tissue for cytological/histological tests, which comprises a needle (2) which can move from a non-working position to a working position, and vice versa, to take a sample of tissue to be examined; the device (1) is configured to be connected to a distal portion (26) of an instrument (25) designed to perform clinical tests; once connected to the distal portion (26) of the instrument (25) designed to perform clinical tests, the device (1) defines a working means located outside the instrument (25).

Description

DESCRIPTION

DEVICE FOR TAKING SAMPLES OF BIOLOGICAL TISSUE. Technical field

This invention relates to a device for taking samples of biological tissue for subsequent cytological/histological tests.

Background art

This method is nowadays increasingly used in the routine practice of performing clinical tests on humans and animals.

In general, the devices for taking samples of biological tissue foresee the use of a tissue sample needle which moves from a non-working position to a working position in order to penetrate the tissue to be examined, and vice versa.

To take tissue samples from internal organs, one normally uses an instrument commonly called an echo-endoscope, that is to say an endoscope equipped at its end with an ultrasound probe.

The sample is usually taken by inserting the endoscope in the gastrointestinal or tracheo-bronchial lumen of the patient with the aid of the ultrasound probe until the desired position for the transmural or transluminal sampling is reached.

The needle is inserted in the relative channel of the endoscope and protrudes from the distal portion of the endoscope in order to take the sample, usually by means of the needle aspiration method.

Since the sampling needle is inserted inside the endoscope channel to protrude from its distal portion, it is only possible to use needles with certain sizes and shapes that allow the maneuvers necessary to move the needle inside the channel of the endoscope which, during the procedure, assumes angled positions and curvatures not exactly appropriate for the transit, inside the channel, of the needle in one direction or the other.

This involves considerable operational restrictions due to the limited possibility of dimensional and structural development of the needle, resulting in tissue samples that are not appropriate for the purposes of the subsequent clinical analyses and/or the impossibility of acquiring in situ samples.

Disclosure of the invention

It was therefore felt necessary to provide a device for taking samples of biological tissue for cytological/histological tests, which comprises a needle (2) which can move from a non-working position to a working position, and vice versa, to take a sample of tissue to be examined, and a main body to house at least part of the needle.

The device is designed to be connected at least in part to a distal portion of an instrument for performing clinical tests, preferably an endoscope, more specifically an echo-endoscope, in such a way that at least the main body housing the needle is positioned outside the instrument.

Advantageously, since the main body housing the needle according to the invention is a working means outside the instrument, the dimensional and conformation features of the sampling needle are totally free from the physical limits connected with the transit of the needle inside the channel of the analysis instrument, thus overcoming the mentioned prior art drawbacks.

Brief description of the drawings

This and other features will become more apparent from the following description of a preferred embodiment of the invention, illustrated by way of a non-limiting example in the accompanying tables of drawings, in which:

- Figure 1 shows a simplified prospective view of the device for taking samples of biological tissue for cytological/histological tests according to this invention;

- Figure 2 shows a schematic view of the device according to this invention, connected to the end of an endoscope, in particular an echo- endoscope, as in practice and in a first configuration;

- Figure 2a shows a schematic view of the device in figure 2, with some parts cut away in order to better illustrate others, in a second configuration; - Figure 2b shows a schematic view of the proximal portion of the device in figures 2 and 2a;

- Figures 3 and 4 show simplified cross-section views of two variations of the device according to the invention;

- Figures 5 and 6 show schematic prospective views, with some parts cut away in order to better illustrate others, of the device according to the invention during its use.

Detailed description of preferred embodiments of the invention

The numeral 1 denotes a device for taking samples of biological tissue for cytological/histological tests according to this invention.

In particular, the device 1 is designed to take tissue samples of the internal organs of humans or animals.

The device 1 comprises a needle 2 which can move from a non-working position to a working position, and vice versa, to take a sample of tissue to be examined.

The needle 2 presents a portion of one end 3 shaped to cut the tissue during the procedure for taking the sample.

It can be seen that, during the sampling procedure, the needle 2 performs a tissue core boring operation so that at least one portion of the needle 2, close to the end portion 3, acts as a means for housing and restraining the tissue sample taken.

In the non-working position of the needle 2, the end 3 of the needle 2 is in a proximal retracted position, shown in figure 2.

In the working position of the needle 2, the end 3 of the needle 2 is in a distal position, outside the device 1 , in order to penetrate the tissue to be examined, shown in figure 2a. The device 1 comprises a main body 5 inside which the needle 2 is at least partially housed.

The main body 5 comprises at least one covering element 15 of at least part of the needle 2.

The covering element 15 is located at one end of the main body 5.

The covering element 15 presents a through housing 17 in which the needle 2 slides during its movement from a non-working position to a working position, and vice versa.

In the non-working position of the needle 2, the covering element 15 protects the end 3 of the needle 2, as shown in figure 2.

According to the invention, the device 1 is configured to be connected at least in part to a distal portion 26 of an instrument 25 for performing clinical tests.

This instrument 25 for performing clinical tests is preferably an endoscope. More specifically, the instrument 25 for performing clinical tests is an echo- endoscope, as shown in figures 2 and 2a, presenting at its end an ultrasound probe 33.

The distal portion 26 of the instrument 25 to which the device 1 is connected is designed to be inserted in the lumens of the patient.

The term lumen means the gastro-intestinal lumen or the tracheobronchial lumen of the patient.

This distal portion 26 is proximal to the end of the instrument 25.

As can be seen in figures 2 and 2a, the portion 26 of the instrument 25 on which the device 1 is fitted is proximal to the ultrasound probe 33.

Once the sampling device 1 has been connected to the distal portion 26 of the instrument 25, the main body 5 housing the needle 2 is positioned outside the instrument 25 to perform the clinical tests, acting as a working means for taking samples outside the instrument 25.

Advantageously, since the main body 5 housing the needle 2 is a working means outside the instrument, the dimensional and conformation features of the sampling needle 2 are totally free from the physical limits connected to the transit of the needle 2 inside the channel of the analysis instrument, overcoming the prior art drawbacks.

The calibre or diameter of the needle 2 of the device 1 according to the invention may be less than 19 gauge, preferably in the range between 14 and 18 gauge, limits included.

Advantageously, the above-mentioned dimensions of the end 3 of the needle 2 make it possible to take tissue samples appropriate for the purposes of the subsequent clinical analyses, including tissue core boring for histological tests.

The device 1 comprises means 24 for connecting the main body 5 with the distal portion 26 of the instrument 25 for performing clinical tests.

The connecting means 24 are configured to join at least part of the outer surface of the distal portion 26 of the instrument 25.

The connecting means 24 are configured to connect and disconnect the main body 5 to and from the distal portion 26 of the instrument 25 in a reversible manner.

Advantageously, the reversible connecting means 24 make it possible to connect at least the main body 5 to the distal portion 26 of the instrument 25, when it is necessary to take tissue samples; in other cases, the instrument 25 for performing clinical tests can be used in the traditional manner.

According to a preferred embodiment, the connecting means 24 comprise a cradle 32 which can be positioned on the distal portion 26 of the endoscope 25 and fixed there by means of a closing strip 34, preferably in elastic material.

The main body 5 is connected to the connecting means 24.

The device 1 comprises means 35 for positioning the main body 5 with respect to a reference element.

This element can be identified as the connecting means 24 of the main body 5 and the distal portion 26.

Nevertheless, it can be observed that once the device 1 has been connected to the distal portion 26 of the instrument 25, the positioning means 35 allow the relative movement between the main body 5 and the distal portion 26 of the instrument 25.

The positioning means 35 are designed to move the main body 5 between at least a first configuration, lowered with respect to the reversible connecting means 24, and a second configuration, inclined with respect to the reversible connecting means 24, and vice versa.

In a preferred embodiment as shown in Figure 2a, the main body 5 oscillates with respect to the underlying cradle 32 of the reversible connecting means 24 by means of a hinged coupling 35 which forms the positioning means.

By means of this solution it is possible to move the main body 5 between a lowered position of Figure 2, in which the needle 2 is parallel to the distal portion 26 of the endoscope 25 and a "ramp" position of the main body 5, wherein the needle 2, see Figure 2a, is inclined at an angle, until reaching a value (β), so that the distal portion 26 of the endoscope 25 is raised in such a way as to favour the best position of the needle 2 for the subsequent step of extracting and removing the tissue under examination. The positioning means 35 are configured to be controlled from a proximal position 31 of the instrument 25 with respect to the distal portion 26, by means of respective operating means 28c.

This proximal position 31 is located at the grip of the endoscope 25, as shown in Figure 2b.

The proximal position 31 of the instrument 25 is located externally with respect to the patient to be treated.

In order to move the needle 2 from the non-working position to the working position, and vice versa, the device 1 comprises means 29 for movement of the needle 2.

The device 1 comprises means 36 for actuating the movement means 29 configured to operate the movement of the needle 2 from the non-working position to the working position, and vice versa. The actuator means 36 are configured to be controlled from the proximal position 31 of the instrument 25.

More specifically, in this preferred embodiment, the actuator means 36 are the pneumatic type.

The actuator means 36 comprise a pressurised fluid 4.

The pressurised fluid 4 is preferably compressed air.

Advantageously, the use of a pressurised fluid 4 for movement of the needle 2 allows the operator to take the sample of tissue to be examined in an accurate manner since it guarantees the operator an adequate response during performance of the procedure.

A source 30 for the supply of the pressurised fluid 4, specifically compressed air, is located externally to the device 1 .

The source 30 is, for example, in the form of pressurised cylinders.

The actuator means 36 comprise separate first and second infeed conduits 19 and 20 of the pressurised fluid 4.

The first and second infeed conduits 19 and 20 are connected to the source 30 of the pressurised fluid 4.

According to a preferred embodiment, the first and second infeed conduits 19 and 20 are aligned along the main body 5, as shown in figure 3.

According to a second embodiment, the first and second infeed conduits 19 and 20 are located on opposite sides of the main body 5, as shown in figure 4.

Each first and second infeed conduit 19 and 20 comprises a respective fixed section 21 and a respective flexible section 22 connected to the fixed section 21 .

The flexible section 22 of the first and second infeed conduits 19 and 20 communicates with the supply source 30 of the pressurised fluid 4.

The flexible section 22 of the first and second infeed conduits 19 and 20 is preferably made from Teflon.

The fixed section 21 of the first and second infeed conduits 19 and 20 is preferably made as a single piece with the main body 5. Advantageously, the reinforcement means 23 maintain a constant cross- section for passage of the fluid 4 in the first and second infeed conduits 19 and 20.

Reinforcement means 23 are positioned at least in part at the level of the connection between the fixed 21 section and the flexible section 22 of the respective first and second infeed conduits 19 and 20.

The actuator means 36 are configured to be located at least in part inside an inner channel 27 of the instrument 25.

Specifically, at least part of the flexible section 22 of the first and second infeed conduits 19 and 20 is located inside an inner channel 27 of the instrument 25.

Alternatively, the actuator means 36 are configured to be located along the outer surface of the instrument 25.

Specifically, at least part of the flexible section 22 of the first and second infeed conduits 19 and 20 is located along the outer surface of the instrument 25.

The means 29 for the movement of the needle 2 are configured to be operated by the pressurised fluid 4 from a first to a second extremity position, and vice versa, corresponding respectively to the non-working and working positions of the needle 2.

The movement means 29 comprise a mobile element 6, sliding inside the main body 5, connected to the needle 2.

The pressurised fluid 4 acts on the mobile element 6 to move it from the first to the second extremity position, and vice versa, which correspond respectively to the non-working and working positions of the needle 2.

The main body 5 is a hollow body 18 circumscribed by a head wall 16, a back wall 13 and side walls 14.

The mobile element 6 forms, inside the main body 5, separate first and second chambers 7 and 8, each being designed to house the pressurised fluid 4 in order to control the movement of the mobile element 6.

Inside the main body 5, the mobile element 6 moves from a first to a second extremity position, and vice versa, which correspond respectively to the non-working and working positions of the needle 2.

The first infeed conduit 19 communicates with the first chamber 7.

The second infeed conduit 20 communicates with the second chamber 8. Specifically, the fixed section 21 of the first and second infeed conduits 19 and 20 communicates with the respective first and second chamber 7 and 8.

The infeed of pressurised fluid 4 into the first chamber 7 controls the movement of the mobile element 6 from the first to the second extremity position, moving the needle 2 from the non-working position to the working position.

The infeed of pressurised fluid 4 into the second chamber 8 controls the movement of the mobile element 6 from the second to the first extremity position, moving the needle 2 from the working position to the non-working position.

Specifically, the mobile element 6 presents a first and a second free surface 9 and 10 on which the pressurised fluid 4 acts to move the needle 2 from the non-working position to the working position, and vice versa. Specifically, according to a preferred embodiment, the first surface 9 has a larger cross-section than the second surface 10 to move the needle 2 from the non-working position to the working position. In this way, the needle 2 has a greater thrust during penetration of the tissue to be examined.

Alternatively, the first surface 9 has the same cross-section as the second surface 10.

In other words, the first chamber 7 is formed by at least part of the inner side walls 14 of the main body 5, the inner back wall 13 of the main body 5 and the first extremity surface 9 of the mobile element 6.

In other words, the second chamber 8 is formed by at least part of the inner side walls 14 of the main body 5, the head wall 16 of the main body 5 and the second extremity surface 10 of the mobile element 6.

The mobile element 6 comprises a first and second stop element 1 1 and 12, each of which defines an end portion of the mobile element 6.

The first and second elements 1 1 and 12 are preferably in the form of shafts 1 1 and 12.

The first and second elements 1 1 and 12 extend from the respective free surfaces 9 and 10 of the mobile element 6.

Advantageously, the first and second elements 1 1 and 12 of the mobile element 6 act as spacer means with respect to the first and second free surfaces 9 and 10 to allow the pressurised fluid 4 to enter the respective first and second chambers 7 and 8.

Specifically, the first and second element 1 1 and 12 form a cross-section with a circular crown conformation of the respective surface 9 and 10 from which they extend.

The first element 1 1 extends from the first free surface 9.

The second element 12 extends from the second free surface 10. Preferably, the needle 2 is connected to the second element 12.

It can be seen that the first element 1 1 forms a stop element of the needle 2 when it is in the non-working position.

It can be seen that the second element 12 forms a stop element of the needle 2 when it is in the working position.

Specifically, at the level of the non-working position of the needle 2, the first element 1 1 strikes the inner back wall 13 of the main body 5.

Specifically, at the level of the working position of the needle 2, the second element 12 strikes the inner head wall 16 of the main body 5.

The head wall 16 presents an opening 16a through which the needle 2 is free to slide in order to move from the non-working position to the working position, and vice versa.

Specifically, the covering element 15 is connected at one of the ends of the main body 5 at the level of the second chamber 8.

The covering element 15 forms the head wall 16 of the main body 5 against which the second element 12 strikes.

It can thus be seen that the cross-section 17 of the covering element 15 forms the through opening 16a of the head wall 16, allowing only the movement of the needle 2 inside it.

It can be seen that the movement of the mobile element 6 inside the main body 5 from the first to the second extremity position, and vice versa, defines the working stroke of the needle 2.

In other words, the working stroke of the needle 2 from the non-working position to the working position, and vice versa, is defined by the stop positions of the mobile element 6 inside the main body.

The working stroke of the needle makes it possible to move the needle 2 from the non-working position to the working position in such a way that the end 3 of the needle 2 can penetrate the tissue to be examined far enough to extract the sample.

The working stroke of the needle makes it possible to move the needle 2 from the working position to the non-working position in such a way that the end 3 of the needle 2 is positioned inside the covering element 15, specifically inside the housing 17, to preserve the extracted sample.

This invention also provides an endoscope 25 that comprises the sampling device 1 positioned at the level of a distal portion 26 designed to be inserted in the lumens of a patient.

The endoscope 25 presents an inner channel 27 housing at least part of the first and second infeed conduits 19, 20 of the pressurised fluid 4, in particular at least part of the respective flexible section 22 of the first and second infeed conduits 19, 20.

In other words, the actuator means 36 are configured to be located at least in part inside an inner channel 27 of the endoscope 25.

Alternatively, the endoscope 25 presents on its outer surface at least part of the first and second infeed conduits 19, 20 of the pressurised fluid 4, in particular at least part of the respective second flexible section 22 of the first and second infeed conduits 19, 20.

The endoscope 25 according to this invention comprises means 28 for activating the means of movement 36 of the device 1 located in a proximal position 31 with respect to the distal portion 26, in particular at the level of the grip of the endoscope 25, as shown in figure 2b.

It can be seen that the proximal position 31 of the endoscope 25 is located outside the body of the patient to be treated.

The endoscope 25 according to the invention comprises means 28c for activating the means 35 for positioning the main body 5 configured to be controlled from the proximal position 31 of the instrument 25.

The activating means 28 allow the operator to control the infeed of the pressurised fluid 4 inside the device 1 .

Specifically, first activating means 28a allow the operator to control the infeed of the pressurised fluid 4 into the first chamber 7 in order to move the needle 2 from the non-working position to the working position, at the level of which the end 3 of the needle 2 penetrates the tissue to be examined.

Second activating means 28b allow the operator to control the infeed of the pressurised fluid 4 into the second chamber 8 in order to move the needle 2 from the working position to the non-working position, at the level of which the sample of tissue remains housed at least in part inside the needle 2 and will be protected from any contamination by the covering element 15.

The source 30 of the pressurised fluid 4 is located externally to the device 25.

Claims

1 . A device for taking samples of biological tissue for cytological/histological tests, which comprises a needle (2) which can move from a non-working position to a working position, and vice versa, to take a sample of tissue to be examined, and a main body (5) housing at least part of the needle (2)

characterized in that

the device (1 ) is configured to be connected at least in part to a distal portion (26) of an instrument (25) designed to perform clinical tests, preferably an endoscope (25), more specifically an echo-endoscope (25), in such a way that at least the main body (5) housing the needle (2) is located outside the instrument (25).

2. A device according to claim 1 , characterised in that it comprises means (24) for joining the main body (5) with the portion (26) of an instrument (25) used to perform clinical examinations.

3. A device according to claim 2, characterised in that the connecting means (24) are configured to connect at least part of the outer surface of the distal portion (26) of the instrument (25).

4. A device according to claim 2 or 3, characterised in that the connecting means (24) are configured to connect the main body (5) with the distal portion (26) of the instrument (25) in a reversible manner.

5. A device according to any of the foregoing claims, characterised in that it comprises positioning means (35) of the main body (5) configured to move the main body (5) at least from a first configuration to a second configuration with respect to the reference element (24; 26).

6. A device according to claim 5, characterised in that in the first configuration the needle (2) housed in the main body (5) is positioned parallel to the distal portion (26) of the instrument (25) and that in the second configuration the needle (2) housed in the main body (5) is positioned at an angle with respect to the portion (26) of the instrument (25).

7. A device according to claim 5 or 6, characterised in that the positioning means (35) are configured to be controlled from a proximal position (31 ) of the instrument (25) for performing clinical tests, in particular at level of the grip of the endoscope (25).

8. A device according to any of the foregoing claims, characterised in that it comprises means (29) for movement of the needle (2), configured to move the needle (2) from the non-working position to the working position, and vice versa, and means (36) for activating the movement means (29).

9. A device according to claim 8, characterised in that the actuator means (36) comprise a pressurised fluid (4), in particular compressed air, and separate first and second conduits (19, 20) for infeed of the pressurised fluid (4).

10. A device according to claim 9, characterised in that the first and second infeed conduits (19, 20) comprise a respective fixed section (21 ) and a respective flexible section (22) connected to the first fixed section (21 ).

1 1 . A device according to claim 10, characterised in that it comprises reinforcement means (23) positioned at least in part at the level of the connection between the first fixed section (21 ) and the second flexible section (22) of the respective first and second infeed conduits (19, 20) to maintain a constant cross-section for passage of the pressurised fluid (4).

12. A device according to any of the foregoing claims from 8 to 1 1 , characterised in that the actuator means (36) are configured to be located at least in part inside an inner channel (27) of the instrument (25) for performing clinical tests; in particular, at least part of the first and second infeed conduits (19, 20) are configured to be located at least in part inside the inner channel (27) of the instrument (25).

13. A device according to any of the foregoing claims from 8 to 1 1 , characterised in that the actuator means (36) are configured to be located along the external surface of the instrument (25) for performing clinical tests; in particular, at least part of the first and second infeed conduits (19, 20) are configured to be located at least in part along the external surface of the instrument (25).

14. A device according to any of the foregoing claims from 8 to 13, characterised in that the actuator means (36) are configured to be controlled from a proximal position (31 ) of the instrument (25), in particular at the level of the grip of the endoscope (25), by means of respective activating means (28).

15. A device according to any of the foregoing claims from 8 to 14, characterised in that the means (29) for movement of the needle (2) are configured to be activated by the pressurised fluid (4) from a first to a second extremity position, and vice versa, corresponding respectively to the non-working position and the working position of the needle (2).

16. A device according to claim 15, characterised in that the movement means (29) comprise a mobile element (6), housed inside the main body (5), connected to the needle (2); the mobile element (6) defining within the main body (5) a first chamber (7) and a second chamber (8), separate from each other and each designed to house the pressurised fluid (4) to control the movement of the mobile element (6) from the first to the second extremity position, and vice versa, which correspond respectively to the non-working and working positions of the needle (2).

17. A device according to claim 16, characterised in that the mobile element (6) comprises a first and second stop element (1 1 , 12), each of which defines an end portion of the mobile element (6); the working stroke of the needle (2) being defined by the movement of the mobile element (6) between the stop positions of the first and second elements (1 1 , 12) inside the main body (5) respectively against the back wall (13) and the head wall (16) of the main body (5).

18. A device according to claim 17, characterised in that the head wall (16) presents an opening (16a) through which the needle (2) is free to slide in order to move from the non-working position to the working position, and vice versa.

19. A device according to any of the claims from 16 to 18, characterised in that the first infeed conduit (19) of the actuator means (36) is in fluid communication with the first chamber (7) of the main body (5), and the second infeed conduit (20) of the actuator means (36) is in fluid communication with the second chamber (8) of the main body (5), in particular the fixed section (21 ) of the respective first and second infeed conduits (19, 20) being in communication with the respective first and second chamber (7, 8) of the main body (5).

20. A device according to any of the foregoing claims, characterised in that the main body (5) comprises at least one covering element (15) of at least part of the needle (2); the covering element (15) being positioned at one end of the main body (5) in order to protect the tip (3) of the needle (2) at the level of the non-working position.

21 . An endoscope comprising a device (1 ) for taking samples of biological tissue according to any of the foregoing claims from 1 to 20 located at the level of a distal portion (26) designed to be inserted inside the lumens of a patient; the main body (5) of the device (1 ) defining a working means of sampling external to the endoscope (25).

22. An endoscope according to claim 21 , characterised in that it presents an inner channel (27) containing at least part of the means (36) for activating the means (29) for movement of the needle (2), in particular at least part of the first and second infeed conduits (19, 20) of the pressurised fluid (4).

23. An endoscope according to claim 21 , characterised in that along the outer surface of the endoscope (25) at least part of the means (36) for activating the means (29) for movement of the needle (2) are positioned, in particular at least part of the first and second infeed conduits (19, 20) of the pressurised fluid (4).

24. An endoscope according to any of the foregoing claims from 21 to 23, characterised in that it comprises means (28) for activating the actuator means (36) located in a proximal position (31 ) of the endoscope (25), in particular at the level of the grip of the endoscope (25).

25. An endoscope according to any of the foregoing claims from 21 to 24, characterised in that it comprises means (28c) for activating the positioning means (35) of the main body (5), located in a proximal position (31 ) of the endoscope (25), in particular at the level of the grip of the endoscope (25).