WO2006131388A1

WO2006131388A1 - Biopsy device

Info

Publication number: WO2006131388A1
Application number: PCT/EP2006/005545
Authority: WO
Inventors: Armando Belluomo
Original assignee: H.S. Hospital Service S.P.A.
Priority date: 2005-06-10
Filing date: 2006-06-09
Publication date: 2006-12-14
Also published as: ITMO20050143A1

Abstract

A device (1) for biopsy that comprises a mandrel (4) provided at a distal end thereof , with a seat (4a) for receiving a sample of tissue, a hollow needle (5) arranged concentrically outside said mandrel (4), said mandrel (4) and said hollow needle (5) being movable with respect to one another in a direction that is substantially parallel to the respective longitudinal axes, said mandrel (4) and said hollow needle (5) are drivable to slide in said direction through automatic driving means (17, 24, 24a), said automatic driving means (17, 24, 24a) driving in sequence both the mandrel (4) and the hollow needle (5).

Description

Biopsy device

The present invention relates to a biopsy device, of the so- called "guillotine" type, namely a device for taking samples of organic tissue, in particular for the diagnosis and the treatment of tumours or other pathologies .

From the state of the art biopsy devices are known of the so-called "guillotine" type, consisting of a substantially cylindrical mandrel, near the tip of which a housing is obtained, - for example obtained by making a flattening along a portion of the mandrel - suitable for receiving the sample to be taken, and of a hollow needle with a cutting tip, slidingly coupled externally to said spindle. The housing has dimensions that are such as to receive a sample of tissue of sufficient size for the histiological examinations to be conducted thereupon.

In order to conduct the biopsy, the device is introduced into the body of the patient, with the mandrel retracted inside the hollow needle so that only the tip thereof protrudes. When the tip of the mandrel has reached the zone of the body of the patient from which the sample has to be taken the mandrel is made to emerge from the needle by reciprocal axial sliding. In this way a portion of the tissue surrounding the mandrel penetrates the housing obtained on the mandrel. At this point the hollow needle is moved until it covers said housing in such a way that the cutting tip of the hollow needle separates, with a guillotine action, the portion of tissue that has penetrated into the aforementioned housing from the surrounding area. Biopsy devices are known in which the movements of the mandrel and of the hollow needle are achieved through thrust means, for example elastic thrust means, that is operatable by the operator.

From US-A-5, 127,419 a biopsy device is known comprising a case provided with a hole that extends along a longitudinal axis of the casing and a track that extends parallel to the hole and along which a proximal slit and a distal slit are made in the wall of the casing, which are parallel to said longitudinal axis. The device furthermore comprises a mandrel that is provided, near a tip thereof, with a housing for receiving a tissue sample, and a hollow needle, or cannula, that is coaxial to the spindle and is slidable upon it and inside said longitudinal hole; a guiding element is slidingly coupled in the aforementioned track and is provided with a longitudinal proximal slit provided with a notch at an end thereof and a longitudinal distal slit, which is also provided with a notch at an end thereof; the mandrel is provided with a guiding pin for coupling with the guiding element, the guiding pin extending in a direction that is perpendicular to the longitudinal axis of the mandrel through the proximal slit of the casing and the proximal slit of the guiding element; the hollow needle is also provided with a guiding pin that extends in a direction perpendicular to the longitudinal axis of the needle through the distal slit of the casing and the distal slit of the guiding element; when the guiding element is moved toward the tip of the mandrel along the track, the guiding pin of the mandrel engages in the latter and the mandrel is made to emerge from the hollow needle until the guiding pin reaches the distal end of the proximal slit of the casing; by moving the guiding element further along the path the guiding pin of the cannula engages in the latter and advances it until it covers the spindle until the guiding pin reaches the distal end of the distal slit of the casing.

Manoeuvring the guiding element by the operator may be difficult with the risk of diverting the tip of the mandrel from the point in which it was inserted.

In order to overcome this disadvantage, biopsy devices have been proposed, which are also called "biopsy guns", in which the movements of the mandrel and of the cannula are obtained by means of elastic elements, such as, for example, springs. These devices are in general very complex and cumbersome, not easy to handle and to drive . The object of the present invention is to provide a biopsy device in which the advance of the mandrel and of the hollow needle are controlled automatically, that is relatively easy to construct and easy to handle and drive. According to the present invention a biopsy device is provided comprising a mandrel provided at a distal end thereof with a seat for receiving a sample of tissue, a hollow needle arranged concentrically outside said spindle, said spindle and said hollow needle being movable with respect to one another in a direction that is substantially parallel to the respective longitudinal axes, characterised in that said spindle and said hollow needle are drivable to slide in said direction through automatic driving means, said automatic driving means shifting in sequence first the mandrel and, subsequently, the hollow needle between a respective first position and a respective second position. Owing to the invention the steps for conducting a biopsy, after insertion of the spindle and of the hollow needle into the body of the patient, are conducted automatically, the only task that the operator conducting the biopsy has to perform is to activate the automatic driving means. This enables the operator to be able to easily maintain the device in the correct position whilst conducting the biopsy, not having to perform manual tasks to make the needle and the cannula advance .

Some embodiments of the invention will be disclosed below purely by way of non- limitative example, with reference to the enclosed drawings, in which: Figure 1 is a longitudinal section of a device according to the invention, in a first operating position; Figure 2 is a detail of Figure 1;

Figure 3 is a longitudinal section of a device according to the invention, in a second operating position; Figure 4 is a detail of Figure 3; Figure 5 is a longitudinal section of a device according to the invention, in a third operating position; Figure 6 is a detail of Figure 5 ;

Figure 7 is a raised side view of a device according to the invention, without spindle and hollow needle;

Figure 8 is the view from the right of Figure 7; Figure 9 is a view like the one in Figure 7, from the side opposite the one in Figure 7 ;

Figure 10 is a view from the right of Figure 9;

Figure 11 is the enlarged section XI-XI of Figure 7 ;

Figure 12 is a longitudinal section of a support and guide element of the spindle and of the hollow needle;

Figure 13 is a longitudinal section of the upper part of the support and guide element of the Figure 12;

Figure 14 is a longitudinal section of the lower part of the support and guide element of Figure 12 ; Figure 15 is a view from above of the support and guide element in Figure 12;

Figure 16 is the section XVI-XVI of Figure 15;

Figure 17 is a view from below of the support and guide element in Figure 12 ; Figure 18 is the section XVIII-XVIII of figure 17;

Figure 19 is a plan view of a driving element of the mandrel and of the hollow needle;

Figure 20 is a longitudinal section of the driving element of Figure 19; Figure 21 is a view like the one in Figure 15, with the driving element inserted into the support and guide element, in a first operating condition;

Figure 22 is a view like the one in Figure 21, with the driving element in a second operating condition; Figure 23 is a view like the one in Figure 21, with the driving element in a third operating condition;

Figure 24 is a view like the one in Figure 2, in which the position of the driving element has been highlighted;

Figure 25 is a view like the one in Figure 4, in which the position of the driving element has been highlighted; Figure 26 is a view like the one in Figure 6, in which the position of the driving element has been highlighted; Figure 27 is a raised view of a slide that drives the driving element of the mandrel and of the hollow needle; Figure 28 is a view like the one in Figure 27, but on the opposite side of the slide means.

With reference to Figure 1,. 1 shows a device according to the invention, comprising an internally hollow body 2, in the upper part of which through a movable cover 2a, a support and guide element 3 is insertable with which a mandrel 4 and a hollow needle or cannula 5 are slidingly coupled, the cannula 5 being externally coaxial to the mandrel 4. The mandrel 4 is fixed, at a proximal end thereof to a first slider 6 that is slidable inside the support and guide element 3. The first slider 6 is provided with an upper guiding pin 7, slidingly coupled in a first longitudinal slit 8 made in the upper part 9 of the support and guide element 3, and with a lower pin 10, slidingly coupled in a second longitudinal slit 11, made in the lower part 12 of the support and guide element 3.

The cannula 5 is fixed, at a proximal end thereof, to a second slider 13, that is slidable inside the support and guide element 3. The second slider 13 is provided with an upper guiding pin 14 slidingly coupled in a third longitudinal slit 15, made in the upper part 9 of the support and guide element 3 , aligned with the first slit 8, but separated from it. The second slider 13 is furthermore provided with a lower pin 16 slidingly coupled in said second longitudinal slit 11.

The lower pin 10 of the first slider 6 and the lower pin 16 of the second slider 13 are coupled with a driving element 17 (Figures 19 e 20) slidingly coupled with the lower part 12 of the support and guide element 3. The driving element 17 is provided, at the proximal end thereof, with a recess 18, intended to be coupled with the lower pin 10 of the first slider 6. The entrance 19 to the recess 18 has a width that is less than the diameter of said lower pin 10, so that the latter can enter and exit the recess 18 only through forcing. The driving element 17 is furthermore provided with a hole 20 intended to be coupled with a dragging pin that will be disclosed below.

Lastly, the driving element 17 is provided with a longitudinal groove 21, in which it is intended to slidingly couple the lower pin 16 of the second slider 13. The recess 18, the hole 20 and the groove 21 are aligned along the longitudinal axis of the dragging element 17. The groove 21 is provided, near a proximal end 23 thereof, with a narrowing 22 having a lesser width than the diameter of said lower pin 16, so that the lower pin 16 can be retained at the proximal end of the groove 21. The dragging element 17 is driven by a slide 24 that is slidable on a shaft 25 and is provided with a pin 26 that protrudes above from the slide 24 and is suitable for engaging in the hole 20 of the dragging element 17 for moving it in a direction parallel to the longitudinal axis of the device 1. The slide 24 is coupled with a spring 24a that opposes the movement of the slide 24, when the latter is moved from a distal end-of-stroke position shown in Figure 5, to a proximal end-of-stroke position, shown in Figure 1.

In the position illustrated in Fig. 5, the slide 24, the dragging element 17 and the sliders 6 and 13 are all in the respective distal end-of-stroke positions. In this situation, .the spring 24a connected to the dragging slide is unloaded and the hollow needle 5 covers the mandrel 4 almost completely, only tip of which protruding from the hollow needle 5. If the slide 24 is moved from the distal end-of-stroke position shown in figure 5 to the proximal end-of-stroke position shown in Figure 1, first the dragging element 17 moves the first slider 6 and, with it the cannula 5 to a proximal end-of-stroke position thereof. Dragging of the first slider 5 by the dragging element 17 is ensured by the fact that the lower pin 10 of the first slider 5 is inserted into the proximal end 23 of the groove 21 of the dragging element 17 and cannot emerge from said end through the effect of the narrowing 22.

When the slide 24 reaches an intermediate position, shown in Figure 3, the first slider 6 reaches the proximal end-of- stroke position, with the upper pin 7 at the proximal end of the first slit 8. In this position, the hollow needle 5 leaves a distal end portion of the mandrel 4 uncovered, in which a seat 4a is obtained that is intended to receive a sample of organic tissue (Figure 4). If the slide 24 is moved to the proximal end-of-stroke position, the lower pin 10 of the first slider 6 is forced to pass through the narrowing 22 and can then slide freely- inside the slit 21. Simultaneously, the lower pin 16 of the second slider 13 engages in the seat 18 obtained at the proximal end of the driving element 17, crossing the narrowing 19. The second slider 13 is then dragged by the driving element 17, thus following the movement of the slide 24, until it reaches the proximal end-of-stroke position. The movement of the second slider 17 causes the mandrel 4 to be withdrawn inside the hollow needle 5, from which, at the end, only the the tip of the mandrel 4 protrudes, whilst the seat 4a is completely inside the hollow needle 5. When the slide 24 has reached the proximal end-of-stroke position, shown in Figure 1, the spring 24a is loaded. In this condition, the device according to the invention is arranged for conducting a biopsy, as will be disclosed below. The dragging slide 24 is provided with a longitudinal through hole 24b in which it couples the shaft 25 with play; furthermore, on each of the sides 27, 28 thereof parallel to the longitudinal axis of the shaft 25, the slide 24 is provided with a respective slit 29, 30 that extends in a direction substantially parallel to said longitudinal axis. The upper side 31 of the slit 29 and the lower side 32 of the slit 30 are shaped as a cam profile. The shaft 25 is provided with a transverse pin 33 that, during sliding of the slide 24 engages, with the ends thereof, the cam profiles 31 and 32. The cam profiles 31 and

32 are shaped in such a way that, by interacting with the transverse pin 33 they are able to lock the slide 24 both in an intermediate position shown in figure 3, between the proximal end-of-stroke position illustrated in Figure 1 and the distal end-of-stroke position shown in Figure 5, and in the proximal end-of-stroke position, preventing the spring 24a from returning the slide 24 back to the distal end-of- stroke position.

The positions in which the transverse pin 33, by interacting with the cam profiles 31 and 32 locks the slide 24, are marked by A, B and A', B' on the respective cam profiles. To enable the spring 24a to return the slide 24 to the distal end-of-stroke position, starting from the intermediate position, or from the proximal end-of-stroke position, it is necessary to rotate the shaft 25 by a certain amount, to disengage the ends of the transverse pin

33 from the cam profiles 31 and 32. This rotation can be obtained by acting on a second pin 36 that protrudes from the proximal end of the shaft 25, in a direction substantially perpendicular to both the axis of the shaft 25 and the pin 33. On the second pin 36 an operating stem 37 acts that is arranged perpendicularly to the pin 36 and is drivable by means of a pushbutton 38. By pressing the pushbutton 38 the operating stem 37 pushes the pin 36 causing rotation of the shaft 33 around the longitudinal axis thereof. This rotation causes the disengagement of the ends of the pin 33 from the cam profiles 31 and 32, so that the slide 24, through the effect of the action of the spring 24a, is moved from the proximal end-of-stroke position, or from the intermediate position, to the distal end-of-stroke position. In order to avoid incorrect or untimely driving of the operating stem 37 a locking device is provided consisting of a pawl 39 that can rotate around an axis 40 parallel to the longitudinal axis of the shaft 25 and is driven by a lever 41. The pawl 39 is movable between an active position in which it prevents rotation of the pin 36 and therefore of the shaft 25 and a neutral position in which it does not interfere with the pin 36.

The rotation of the shaft 25 for disengaging the ends of the pin 33 from the cam profiles 31 and 32 can also be obtained by means of a lever 42 that acts on the distal end of the shaft 25. The slide 24 can be driven to run along the shaft 25 to load the spring 24a by means of a slider 43 that is slidable in the lower part of the body 2. The slider 43 is provided, at the distal end thereof with a lever 44 pushed upwards by a spring 45 and suitable for engaging in seats 46, 47 obtained in the lower part of the slide 24.

A first seat 46 is used for sliding the slide from the distal end-of-stroke position to the intermediate position whereas the second seat 47 is used to slide the slide 24 from the intermediate position to the proximal end-of-stroke position.

The slider 43 is provided with a recess 48 and with a protrusion 49 for facilitating the driving of the slider by an operator. The zone of the slider 43 in which the recess 48 and the protrusion 49 are obtained is accessible from outside the body 2 through a window 50 made in the lower part of the body 2.

To conduct a biopsy, the operator acts on the slider 43 to move the slide 24 from the distal end-of-stroke position to the proximal end-of-stroke position, in which the hollow needle 5 covers the mandrel 4 leaving only the tip of the mandrel 4 (Figure 1) protruding therefrom. At that point, the operator introduces the spindle and the cannula into the body of the patient until it reaches the zone in which the biopsy has to be carried out.

Subsequently, with the slide 24 that is locked in its proximal end-of-stroke position by the pin 33 of the shaft 25, the pushbutton 38 is pressed or the lever 42 is actuated to disengage the slide 24 from the pin 33 and enable the spring 24a to drag the slide 24 to the distal end-of-stroke position (Figure 3) . During the stroke of the slide 24 to the proximal end-of-stroke position first the mandrel 4 is pushed forwards, emerging from the hollow needle 5, so that the flattening 4a remains uncovered and the tissue surrounding the mandrel 4 can penetrate thereinto (Figure 2) . Subsequently, by continuing the motion of the slide 24, the hollow needle 5 is made to advance covering again the flattening 4a and separating from the surrounding tissue the portion of tissue that had penetrated the aforementioned flattening. In the practical embodiment, the materials, the dimensions and the constructional details may be different from those indicated but be technically equivalent thereto without falling outside the realm of legal protection of the present invention.

Claims

1. Device (1) for biopsy comprising a mandrel (4) provided at a distal end thereof with a seat (4a) for receiving a sample of tissue, a hollow needle (5) arranged concentrically outside said mandrel (4), said mandrel (4) and said hollow needle (5) being movable with respect to one another in a direction that is substantially parallel to the respective longitudinal axes, characterised in that said mandrel (4) and said hollow needle (5) are drivable to slide in said direction through automatic driving means (17, 24, 24a), said automatic driving means (17, 24, 24a) driving in sequence first the mandrel (4) then the hollow needle (5) .

2. Device (1) according to claim 1, wherein said hollow needle (5) is connected, at a proximal end thereof, to a first slider (6) drivable by said automatic driving means (17, 24, 24a) .

3. Device (1) according to claim 1, or 2, wherein said mandrel (4) is connected, at a proximal end thereof, to a second slider (13) drivable by said automatic driving means (17, 24, 24a) .

4. Device (1) according to any preceding claim, wherein said automatic driving means (17, 24, 24a) comprises a dragging element (17) suitable for coupling with said first slider (6) and said second slider (13) .

5. Device according to claim 4, wherein said first slider is provided with coupling means (10) for coupling with said dragging element (17) .

6. Device according to claim 5, wherein said coupling means comprises a lower pin (10) protruding below from said first slider (6) .

7. Device according to claim 6, wherein said dragging element (17) is provided with a longitudinal slit (21) suitable for coupling with said lower pin (10) of the first slider (6) .

8. Device (1) according to claim 7, wherein said slit (21) is provided, near a proximal end (23) thereof, with a narrowing (22) having a lesser width than the diameter of said first pin (10) .

9. Device (1) according to any one of claims 3 to 8 , wherein said second slider (13) is provided with coupling means (16) for coupling with said dragging element (17) .

10. Device (1) according to claim 9, wherein said coupling means comprises a lower pin (16) protruding below from said second slider (13) .

11. Device (1) according to claim 10, wherein said dragging element is provided, at a proximal end thereof, with a seat

(18) suitable for coupling with said lower pin (16) of said second slider (13) .

12. Device (1) according to claim 11, wherein said seat (18) is provided with an entrance (19) having a lesser width than the diameter of said lower pin (16) of the second slider (13) .

13. Device (1) according to any one of claims 2 to 12, wherein said first slider (6) and said second slider (13) are inserted into and slidingly coupled with a support and guide element (3) insertable into an internally hollow body (2) of the device (1) , said support and guide element (3) also housing said dragging element (17) .

14. Device (1) according to claim 13, wherein said support and guide element (3) is provided with a first longitudinal slit (8) made in an upper part (9) of the support and guide element (3) , an upper pin (7) of said first slider (6) being slidingly couplable in said first longitudinal slit (8) .

15. Device (1) according to claim 13, or 14, wherein said support and guide element (3) is provided at the bottom with a second longitudinal slit (11) made in a lower part (12) of said support and guide element (3) , the lower pin (10) of said first slider (6) and the lower pin (16) of said second slider (13) being slidingly couplable in said second longitudinal slit (11) in which an upper pin (7) of said first slider (6) is slidingly couplable.

16. Device (1) according to any one of claims 13 to 15, wherein said support and guide element (3) is provided with a third longitudinal slit (15) made in an upper part (9) of the support and guide element (3) , an upper pin (14) of said second slider (13) being slidingly couplable in said third longitudinal slit (15) .

17. Device (1) according to any one of claims 4 to 16, wherein said automatic driving means (17, 24, 24a) comprises sliding means (24) provided with coupling means (26) for coupling with said dragging element (17) .

18. Device (1) according to claim 17, wherein said coupling means comprises a pin (26) protruding from said sliding means (24) and suitable for coupling with a hole (20) made in said dragging element (17) .

19. Device (1) according to claim 17, or 18, wherein said sliding means (24) is coupled with elastic means (24a) .

20. Device (1) according to any one of claims 17 to 19, wherein said sliding means is slidingly coupled with a shaft

(25) the longitudinal axis of which is substantially parallel to the longitudinal axes of said hollow needle (5) and of said mandrel (4) , said shaft (25) being supported at the ends on said body (2) .

21. Device (1) according to claim 20, wherein said sliding means (24) is provided, on a pair of sides (27, 28) parallel to the longitudinal axis of the shaft (25) , with a respective slit (29, 30) that extends in a direction that is substantially parallel to said longitudinal axis.

22. Device (1) according to claim 21, wherein an upper side (31) of the slit (29) and a lower side (32) of the slit (30) are shaped as a cam profile.

23. Device (1) according to claim 22, wherein said shaft (25) is provided with a transverse pin (33) suitable for interacting with said cam profiles (31, 32) .

24. Device (1) according to claim 22, or 19, wherein said cam profiles (31, 32) are provided with respective profile portions (A, B; A' , B' ) that are suitable for constituting a stop for said transverse pin (33) of the sliding means (24) .

25. Device (1) according to claim 24, wherein disengaging means (36, 37, 38) is provided that is suitable for disengaging said transverse pin (33) of the sliding means (24) from said portions (A, B; A', B') of said cam profiles (31, 32) .

26. Device (1) according to claim 25, wherein said disengaging means comprises a stem (37) that is actuatable to slide by means of a pushbutton (38) .

27. Device according to claim 26, wherein said disengaging means comprises a further pin, (36) that protrudes from a near end of the shaft (25) , in a direction substantially perpendicular to the axis of the shaft (25) and to the pin (33), said further pin (36) interacting with said stem (37) .

28. Device according to claim 27, furthermore comprising a locking device of said further pin (36) comprising a pawl (39) that can rotate around an axis (40) parallel to the longitudinal axis of the shaft (25) and is actuatable by a lever (41) .

29. Device according to any one of claims 17 to 28 wherein said sliding means (24) is drivable to slide on said shaft (25) by means of a slider (43) arranged in a lower part of said grip (2) .

30. Device according to claim 29, wherein said slider means (43) is provided at a distal end thereof with a lever (44), suitable for engaging in seats (46, 47) obtained in the slide (24) .

31. Device according to claim 30, wherein said lever (44) is associated with elastic means (45) suitable for pushing an end of the lever (44) toward said sliding means (24) .

32. Device according to any one of claims 29 to 31 wherein said slider means is accessible through an opening (50) made in a lower part of said body (2) .

33. Device (1) according to any one of claims 29 to 32, wherein said slider (43) is provided with a recess (48) and with a protrusion (49) suitable for facilitating the drive thereof .