EP3223715A1

EP3223715A1 - Biopsy syringe

Info

Publication number: EP3223715A1
Application number: EP15823767.7A
Authority: EP
Inventors: Egidio SERRA; Davide LIPPI
Original assignee: Med Italia Biomedica Srl
Current assignee: Med Italia Biomedica Srl
Priority date: 2014-11-28
Filing date: 2015-11-27
Publication date: 2017-10-04
Also published as: WO2016084047A1; EA033905B1; EA201791172A1; WO2016084047A8

Abstract

Biopsy syringe comprising a needle (2) provided with a cannula (4), which has two slots (8) in the vicinity of its distal end (V), and two grasping tongues (9, 10), which are integral with a further outer cannula (12) arranged around said cannula (4); the cannula (4) is rotated relative to the outer cannula (12) so that the tongues (9, 10) slide along the slots (8); during the rotation of the cannula (4), the tongues (9, 10) are bent towards the inside of the cannula (4) so as to grip a sample of a biological tissue of interest and, therefore, perform a clean resection of said sample.

Description

BIOPSY SYRINGE

TECHNICAL FIELD

The present invention concerns a biopsy syringe.

BACKGROUND TO THE INVENTION

Biopsy syringes are known (see in particular figures 15 and 16) comprising a needle (N) provided with a cannula (C) , which has a wall (W) and an inner lumen (L) . The cannula (C) further comprises a front (distal) end (D) adapted to establish communication between the lumen (L) and the outside, and a slot (S) which is manufactured so as to pass through the wall (W) . The needle (N) is also provided with a tongue (T) , which is arranged on the outside of the cannula (C) and is adapted to separate a sample from a biological tissue of interest, moving forward in the direction of longitudinal extension of the cannula (C) so as to engage the slot (S) and extend its distal end (E) inside the lumen (L) (figure 16) .

Although widely used today, this type of syringe does not allow a reliable precise resection of a sample from a biological tissue of interest. In particular, it has been observed that in some cases, after use, the sample was not taken and/or a poor quality sample, torn or frayed, was taken.

The patent application with publication number WO2009/036265 describes systems which are adapted to obtain samples of tissue and comprise a cannula provided with a distal opening to receive the tissue sample. A wire arranged in the area of the distal opening can deliver energy to ablate the tissue.

The object of the present invention is to provide a biopsy syringe which overcomes, at least partially, the drawbacks of the known art and at the same time is easy and inexpensive to produce .

SUMMARY

According to the present invention, a biopsy syringe is provided as claimed in the following independent claim and, preferably, in any one of the claims depending directly or indirectly on the independent claim.

BRIEF DESCRIPTION OF THE FIGURES

The invention is described below with reference to the attached figures, which illustrate some non-limiting embodiment examples, in which:

- figure 1 is a perspective view of a syringe according to the present invention;

- figures 2 to 4 illustrate on an enlarged scale a detail of the syringe of figure 1 in different operating configurations;

- figures 5 and 6 are lateral views of a component of the syringe of figure 1;

- figure 7 illustrates on an enlarged scale a part of the component of figures 5 and 6, a detail of which is shown lying on the plane of the sheet;

- figure 8 is a lateral view of a further component of the syringe of figure 1;

- figure 9 illustrates on an enlarged scale a detail of the component of figure 8;

- figures 10 and 11 are a lateral view and a perspective view, respectively, of the detail of figure 9 in a different configuration;

- figures 12 to 14 illustrate on an enlarged scale and with parts removed for clarity a detail of the syringe of figure 1 in successive operating configurations; and

- figures 15 and 16 are perspective views in different operating configurations of a detail of a syringe of the state of the art .

DETAILED DISCLOSURE In figure 1 the number 1 indicates as a whole a biopsy syringe comprising a needle 2 and a moving assembly 3 to operate the syringe 1. The syringe 1 is adapted to separate a sample from a material (biological tissue) . In particular the moving assembly 3 is adapted to operate the syringe 1 so as to move the needle 2 forward and sever a sample of a biological material (tissue) of interest.

With particular reference to figures 2 to 4, the needle 2 comprises a cannula 4 (tubular), which has a (peripheral) wall 5 delimiting an inner lumen 6 of the cannula 4; a front (distal) end 7 adapted to establish communication between the lumen 6 and the outside; and a slot 8, which is manufactured so as to pass through the wall 5.

Typically, the cannula 4 has a longitudinal axis A.

In particular, when at rest, the lumen 6 is completely engaged by a stylet (of known type and not illustrated) which also maintains the end 7 closed. When, in use, the moving assembly 3 operates the syringe 1, the cannula 4 is moved forward relative to the stylet. In this way, the end 7 is opened and the sample of material (biological tissue) can enter the front (distal) portion of the lumen 6.

The syringe 1 (in particular, the needle 2) further comprises at least one grasping tongue 9, which is arranged on the outside of the cannula 4. In particular, the tongue 9 is adapted to penetrate the material (and separate - sever - the sample from the material - biological tissue) .

According to some embodiments, the syringe 1 (in particular, the needle 2) comprises a further grasping tongue 10, which is arranged on the outside of the cannula 4 and is adapted to cooperate with the tongue 9 (to separate a sample from a tissue) . The needle 2 also comprises a further slot 11, which is manufactured so as to pass through the peripheral wall 5. Advantageously, the tongues 9 and 10 are arranged on opposite sides of the cannula 4. It should be noted that the embodiments comprising (at least) the two tongues 9 and 10 are particularly preferred, since the tongues 9 and 10 cooperate to grip the sample of the material in order to perform a particularly precise and clean cut (in other words, reducing the risk of the organic tissue tearing and - together with the sample - fraying) .

Advantageously, the slots 8 and 11 are analogous (identical) to each other and the tongues 9 and 10 are analogous (identical) to each other. According to some embodiments (therefore) , the description below relative to the slot 8 and the tongue 9 also applies to the slot 11 and the tongue 10.

The cannula 4 and the grasping tongue 9 can rotate relative to each other. Figures 2 to 4 illustrate different steps of the relative rotation of the tongue 9 and the cannula 4.

In particular, the slot 8 and the grasping tongue 9 are shaped so that the slot 8 is adapted to bend the grasping tongue 9 towards the inside of the cannula 4 (and engages the lumen 6) as a consequence of a relative rotation of the cannula 4 and the grasping tongue 9. In this way, the grasping tongue 9 separates (severs) the sample from the material.

The structure described enables a relatively high force to be exerted on the tongue 9 which allows adequate penetration of the tongue 9 into the material. This reduces the risk of the material (organic tissue) tearing and (together with the sample) fraying.

More specifically, the slot 8 and the tongue 9 are structured and arranged so that following their relative rotation, the tongue 9 extends at least as far as half (advantageously, over half) of the lumen 6.

In this regard, it should be noted that, advantageously, the tongue 9 has a length at least equal to the diameter of the lumen 6. Advantageously, the slot 8 has an extension measured parallel to the axis A at least equal to at least 0.5 times the diameter of the lumen 6. According to some embodiments, the lumen 6 has a diameter of approximately 0.8 mm to approximately 1.1 mm. In some cases, the tongue 9 has a length of at least 1 mm (up to approximately 2 mm) .

According to some embodiments, the moving assembly 3 is adapted to rotate the grasping tongue 9 and/or the cannula 4 relative to each other so as to obtain a relative sliding of the grasping tongue 9 with respect to the slot 8. In particular, during the sliding of the tongue 9, thanks to the shape of the slot 8 (and of the tongue 9) , the tongue 9 bends so as to extend within the lumen 6 and penetrate the material (more specifically, so as to separate - sever - the sample from the material) . Typically, once the relative rotation of the tongue 9 and cannula 4 has been completed, the tongue 9 engages (continues to engage) the lumen 6 so as to prevent the sample taken coming out through the end 7.

According to specific embodiments, the moving assembly 3 is adapted to rotate the grasping tongue 9 and/or the cannula 4 relative to each other about the longitudinal axis A of the cannula 4.

According to alternative embodiments, the moving assembly 3 is adapted to rotate the grasping tongue 9 and/or the cannula 4 relative to each other about an axis different from the axis A. For example, the tongue 9 can be made to rotate about an axis parallel to the axis A but slightly shifted with respect to said axis A. In this way it is possible to obtain a movement which brings the tongue 9 close to the axis A, and said movement can facilitate insertion of the tongue 9 into the slot 8 and/or extension of the tongue 9 in the lumen 6 towards the axis A.

Advantageously (as can be noted by observing the figures), the cannula 4, in use, is made to rotate with respect to the tongue 9 and the grasping tongue 9 is made to slide along the slot 8.

The syringe 1 comprises a further cannula 12, which is provided with a (peripheral) wall 13 arranged on the outside and at least partially around the wall 5 and comprises the grasping tongue 9 which, more precisely, is arranged in the area of a front (distal) end 14 of the cannula 12 (see, in particular, figures 8-11) . Even more precisely, the tongue 9 projects from the front (distal) end 14 of the cannula 12 in the longitudinal extension direction of the cannula 12 (parallel to the axis A) .

According to preferred embodiments, the cannulas 4 and 12 are substantially coaxial to each other and the end 7 extends beyond the end 14. In particular, the axis A is also the longitudinal axis of the cannula 12.

Typically, the cannulas 4 and 12 (and therefore also the tongues 9 and 10) are made of stainless steel. In particular, the steel is chosen from the group consisting of: AISI 304, AISI 316 (and a combination thereof) .

In particular, the moving assembly 3 is adapted to rotate the cannula 12 relative to the cannula 4 (about the common longitudinal axis A) . According to some embodiments, the slot 8 is adapted to bend the grasping tongue 9 towards the inside by approximately 20°- 40° .

In some cases, the first grasping tongue 9 extends through the slot 8.

Advantageously (figure 9), the grasping tongue 9 has its own front (distal) end 15, which is bent towards the inside of the cannula 4 and which engages at least partially the slot 8. In some cases, the first grasping tongue 9 (in particular, its front end 15) is arranged on the outside of the slot 8 (for example with the end 15 in contact with the wall 5) . In said cases, the tongue 9 (more specifically, its end 15) enters the slot 8 after a first phase of the relative movement (relative rotation) of the tongue 9 and the cannula 4. The insertion into the slot 8 can be facilitated by a small guide arranged on the outside of the wall 5.

According to some embodiments, the end 15 is bent by an angle B of approximately 20°-40° (in particular, 25°-35°; more precisely, approximately 30°) with respect to the main part of the tongue 9.

Figure 9 illustrates an example of tongue 9 with bent end 15. Figures 10 and 11 are relative to the same end 15 according to a different embodiment or before it is machined so that it takes on the particular configuration of figure 9.

Advantageously, the slot 8 is shaped so that (and the grasping tongue 9 is shaped so that) the slot 8 is adapted to twist the grasping tongue 9 as a consequence of the relative rotation of the cannula 4 and of the grasping tongue 9 (more precisely, of the cannula 12) . More precisely, during the sliding of the tongue 9, thanks to the shape of the slot 8 (and of the tongue 9), the tongue 9 twists. According to some embodiments, the tongue 9 twists by approximately 30°-45° (in particular, approximately 40°) .

The twisting of the tongue 9 facilitates cutting of the sample from the organic tissue, consequently reducing the risk of the organic tissue tearing.

With particular reference to figure 7, the slot 8 has (at least) a portion 16 which is oblique relative to the longitudinal extension of the cannula 4 (and therefore to the direction parallel to the axis A) . The portion 16 extends with an angle of approximately 30°-60° (in particular, 35°-55°; more precisely, approximately 45°) relative to the direction of the axis A. More precisely, the portion 16 is laterally delimited by an upper edge 17 and by a lower edge 18 (the edge 17 being nearer than the edge 18 to the end 7) , which extend obliquely relative to the longitudinal extension of the cannula 4 (and to the direction parallel to the axis A) , in particular with respective angles of approximately 30°-60° (in particular, 35°-55°; more precisely, approximately 45°) .

The portion 16 (i.e. the edges 17 and 18) has a length of approximately 0.4 mm to approximately 1.2 mm (more precisely, approximately 0.9 mm) . In particular, in use, the tongue 9 is bent inside the lumen 6 (and twisted) while it slides along the portion 16 due to the coupling with the edge 17.

Advantageously, the slot 8 has a housing portion 19 (which is engaged by the front (distal) end 15 of the grasping tongue 9) and a coupling portion 20, which (is substantially curved) and joins the housing portion 19 to the first oblique portion 16.

The portion 19 extends transversally (in particular, substantially perpendicularly) relative to the longitudinal extension of the cannula 4 (and to the direction parallel to the axis A)

According to some embodiments, the portion 16 extends from the portion 20 (and from the portion 19) in a direction moving away from the end 7.

In particular, the portion 19 is laterally delimited by an upper edge 21 and a lower edge 22 (the edge 21 being nearer than the edge 22 to the end 7) . More precisely, the edges 21 and 22 are transversal (in particular, substantially perpendicular) relative to the longitudinal extension of the cannula 4 (and to the direction parallel to the axis A) .

The portion 20 has a radius of curvature from approximately 0.6 mm to approximately 1.1 mm (in particular, from approximately 0.8 mm to approximately 0.9 mm) .

In particular, the portion 20 is laterally delimited by an upper edge 23 and a lower edge 24 (the edge 23 being nearer than the edge 24 to the end 7) , which connect the edges 17 and 21 and the edges 18 and 22, respectively. More precisely, the edge 23 has a radius of curvature from 0.6 mm to 1 mm. The edge 24 has a radius of curvature from 0.7 mm to 1.1 mm. According to some embodiments, the edge 24 has a radius of curvature greater than the radius of curvature of the edge 23.

With particular reference to the figures 12 and 14, the moving assembly 3 comprises an operating unit 25, which is provided with a support element 26 for the cannula 4, a support element 27 for the cannula 12 and a cam system 28 to enable the relative rotation between the support elements 26 and 27 (the support elements 26 and 27 are mounted rotatable relative to each other and one after the other in the direction of the longitudinal extension of the cannula 4) . The moving assembly 3 further comprises a pushing element 29 (in particular elastic) to move the operating unit 25 (forward) in the direction of the longitudinal extension of the cannula 4 and to transfer the movement to the cam system 28.

The operating unit 25, moving forward, pushes the cannulas 4 and 12 in the direction of their longitudinal extension (parallel to the axis A) so that the end 7 opens (since it is no longer engaged by the above-mentioned stylet) .

According to some embodiments, the pushing element 29 comprises (more precisely is) a spring (helical) .

Advantageously, the cam system 28 comprises a guide 30 (motion link), in particular at least partially helical, and at least one slider 31 which slides along the guide 30. According to some embodiments (like the one illustrated), the guide 30 is obtained on the support element 26 and the slider 31 is integral with an outer element 32 (partially illustrated in figures 12-14) mounted in a sliding manner relative to the support element 26 (and relative to the support element 27) .

The pushing element 29 is adapted to provoke a relative movement between the slider 31 and the guide 30 so that the slider 31 slides along the guide 30 and, consequently, the relative rotation between the support elements 26 and 27 is obtained. In this way, the relative rotation of the cannula 4 and the tongue 9 is also obtained. The support element 27 is adapted to remain rotationally fixed.

In use, the pushing element 29 moves the operating unit 25 forward (including the outer element 32 and the support elements 26 and 27) in the direction of the longitudinal extension of the cannula 4 (parallel to the axis A - figure 12) until one of the support elements 26 and 27 (in particular, the support element 27) comes into contact with a fixed abutment. At this point, the forward movement of the support elements 26 and 27 is stopped, while the outer element 32 continues to be pushed (forward) (figure 13) . The relative movement of the outer element 32 with respect to the support element 26 determines the sliding of the slider 31 which, remaining rotationally fixed, determines the rotation of the support element 26 relative to the support element 27 (figure 14) .

The syringe 1 has a main body 33, which encloses the moving assembly 3. Figures 12 to 14 illustrate an inner portion of the body 33 (figure 1) of the syringe 1 in successive operating phases.

The operating unit 25 is mounted in a sliding manner inside the body 33. According to some embodiments, the support element 26 is mounted so as to be rotatable inside the body 33.

The body 33 is arranged at the opposite end of the cannulas 4 and 12 and of the tongue 9, relative to the ends 7, 14 and 15.

The syringe 1 of the present invention has considerable advantages with respect to the state of the art and, among other things, allows a particularly accurate and clean cut to be made (in other words, the risk of the organic tissue tearing and - together with the sample - fraying is reduced) . In this way it is possible to reduce the risk of damage to the patient and increase the quality of the sample taken.

Claims

1. - A biopsy syringe; the syringe is designed to separate a sample from a material (biological tissue) and comprises a needle (2) provided with a first cannula (4), which has a first peripheral wall (5) delimiting an inner lumen (6) of the first cannula itself, a front (distal) end (7) designed to establish a communication between the lumen (6) and the outside, and at least one first slot (8) , which is manufactured so as to pass through the peripheral wall (5) ; and with at least one first grasping tongue (9) , which is arranged on the outside of the first cannula (4) ; the syringe (1) being characterized in that the first cannula (4) and the first grasping tongue (9) can rotate relative to one another; the first slot (8) and the first grasping tongue (9) being shaped so that the first slot (8) is suited to bend the first grasping tongue (9) itself towards the inside of the first cannula (4) in such a way that the first grasping tongue (9) penetrates the material (and separates said sample from the material itself) as a consequence of a relative rotation of the first cannula (4) and of the first grasping tongue (9) ; the syringe (2) comprising, furthermore, a moving assembly (3) to rotate the first grasping tongue (9) and/or the first cannula (4) relative to one another, so as to obtain a relative sliding of the first grasping tongue (9) with respect to the first slot (8) .

2. - A syringe according to claim 1, wherein the moving assembly (3) is designed to rotate the first grasping tongue (9) and/or the first cannula (4) relative to one another around a longitudinal axis (A) of the first cannula (4) .

3. - A syringe according to claim 1 or 2 and comprising a second grasping tongue (10), which is arranged on the outside of the first cannula (4) and is adapted to cooperate with the first grasping tongue (9) ; and a second slot (11) , which is manufactured so as to pass through the peripheral wall (5) ; the second slot (11) and the second grasping tongue (10) being shaped so that the second slot (11) is adapted to bend the second grasping tongue (10) towards the inside of the first cannula (4) in such a way that the second grasping tongue (10) penetrates the material (and separates said sample from the material itself) as a consequence of a relative rotation of the first cannula (4) and of the second grasping tongue (10) ; the moving assembly (3) being designed to rotate the second grasping tongue (10) and/or the first cannula (4) relative to one another, so as to obtain a relative sliding of the second grasping tongue (10) relative to the second slot (11) ; in particular, the moving assembly (3) is designed to rotate the second grasping tongue (10) and/or the first cannula (4) relative to one another around a longitudinal axis (A) of the first cannula.

4. - A syringe according to one of the preceding claims, and comprising a second cannula (12), which is provided with a second peripheral wall (13) arranged on the outside of and at least partially around the first peripheral wall (5) and comprises the first grasping tongue (9); in particular, the first and the second cannula (4, 12) being substantially coaxial to one another; in particular, the second cannula (12) also comprises the second grasping tongue (10) .

5. - A syringe according to claim 4, wherein the first grasping tongue (9) is arranged in the area of a front (distal) end (14) of the second cannula (12) ; the front (distal) end (7) of the first cannula (4) extending beyond the front (distal) end (14) of the second cannula (12) ; in particular, the second grasping tongue (10) is arranged in the area of the front (distal) end (14) of the second cannula (12) .

6.- A syringe according to one of the preceding claims, wherein the first slot (8) and the first grasping tongue (9) are shaped so that the first slot (8) is adapted to twist the first grasping tongue (9) itself in the presence of the relative rotation of the first cannula (4) and of the first grasping tongue (9) ; in particular, the second slot (11) and the second grasping tongue (10) are shaped so that the second slot (11) is adapted to twist the second grasping tongue (10) itself in the presence of the relative rotation of the first cannula (4) and of the second grasping tongue (10) .

7.- A syringe according to one of the preceding claims, wherein the first grasping tongue (9) has a front (distal) end (15) of its own, which at least partially engages the first slot (8) ; in particular, the second grasping tongue (10) has a front (distal) end of its own, which at least partially engages the second slot (11) .

8. - A syringe according to one of the preceding claims, wherein the first grasping tongue (9) extends through the first slot (8) ; in particular, the second grasping tongue (10) extends through the second slot (11) .

9. - A syringe according to one of the preceding claims, wherein the first grasping tongue (9) has a front (distal) end

(15) , which is bent towards the inside of the first cannula (4) and at least partially engages the first slot (8) ; in particular, the second grasping tongue (10) has a front (distal) end, which is bent towards the inside of the first cannula (4) and at least partially engages the second slot (11) .

10. - A syringe according to one of the preceding claims, wherein the first slot (8) has at least one first portion

(16) , which is oblique relative to the longitudinal extension of the first cannula (4) ; in particular, the second slot (11) has at least one second portion, which is oblique relative to the longitudinal extension of the first cannula (4) .

11. - A syringe according to claim 10, wherein the first slot (8) has a first housing portion (19), which is engaged by the front (distal) end (15) of the first grasping tongue (9), and a first coupling portion (20), which is substantially curved and joins the first housing portion (19) to the first oblique portion (16) ; in particular, the second slot (11) has a second housing portion, which is engaged by a front (distal) end of the second grasping tongue (10), and a second coupling portion, which is substantially curved and joins the second housing portion to the second oblique portion.

12. - A syringe according to one of the preceding claims, wherein the moving assembly (3) comprises an operating unit (25), which is provided with a first support element (26) for the first cannula (4), with a second support element (27) for the second cannula (12), and with a cam system (28) to enable a relative rotation between the first and the second support element (26, 27) ; and a pushing element (29) , in particular an elastic one, to move the operating unit (25) forward in the direction of the longitudinal extension of the first cannula (4) and transfer the movement to the cam system (28) .

13. - A syringe according to claim 12, wherein the cam system (28) comprises a guide (30), in particular an at least partially helical one, and at least one slider (31), which can slide along the guide; the pushing element (29) being designed to provoke a relative movement between the slider (31) and the guide (30), so as to obtain a relative sliding of the slider (31) relative to the guide (30) and, consequently, a relative rotation between the first and the second support element (26, 27) .