Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/0233—Pointed or sharp biopsy instruments
  • A61B10/0266—Pointed or sharp biopsy instruments means for severing sample

Definitions

• the present invention concerns a biopsy syringe.
• 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) .
• T tongue
• this type of syringe does not allow a reliable precise resection of a sample from a biological tissue of interest.
• the sample was not taken and/or a poor quality sample, torn or frayed, was taken.
• 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 .
• 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.
• FIG. 1 is a perspective view of a syringe according to the present invention.
• FIG. 5 and 6 are lateral views of a component of the syringe of figure 1;
• FIG. 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.
• FIG. 10 and 11 are a lateral view and a perspective view, respectively, of the detail of figure 9 in a different configuration
• FIG. 15 and 16 are perspective views in different operating configurations of a detail of a syringe of the state of the art .
• 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) .
• 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.
• 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.
• a cannula 4 tubular
• a front (distal) end 7 adapted to establish communication between the lumen 6 and the outside
• a slot 8 which is manufactured so as to pass through the wall 5.
• the cannula 4 has a longitudinal axis A.
• the lumen 6 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.
• a stylet of known type and not illustrated
• 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.
• the tongue 9 is adapted to penetrate the material (and separate - sever - the sample from the material - biological tissue) .
• 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.
• 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) .
• the slots 8 and 11 are analogous (identical) to each other and the tongues 9 and 10 are analogous (identical) to each other.
• 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.
• 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.
• 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.
• the tongue 9 has a length at least equal to the diameter of the lumen 6.
• 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.
• the lumen 6 has a diameter of approximately 0.8 mm to approximately 1.1 mm.
• the tongue 9 has a length of at least 1 mm (up to approximately 2 mm) .
• 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.
• 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) .
• the tongue 9 engages (continues to engage) the lumen 6 so as to prevent the sample taken coming out through the end 7.
• 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.
• 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.
• 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.
• 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) .
• the cannulas 4 and 12 are substantially coaxial to each other and the end 7 extends beyond the end 14.
• the axis A is also the longitudinal axis of the cannula 12.
• the cannulas 4 and 12 are made of stainless steel.
• the steel is chosen from the group consisting of: AISI 304, AISI 316 (and a combination thereof) .
• the moving assembly 3 is adapted to rotate the cannula 12 relative to the cannula 4 (about the common longitudinal axis A) .
• the slot 8 is adapted to bend the grasping tongue 9 towards the inside by approximately 20°- 40° .
• the first grasping tongue 9 extends through the slot 8.
• 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.
• 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) .
• 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.
• 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.
• 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.
• 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.
• 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) .
• 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.
• 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)
• the portion 16 extends from the portion 20 (and from the portion 19) in a direction moving away from the end 7.
• 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) .
• 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) .
• 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.
• 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.
• the edge 24 has a radius of curvature greater than the radius of curvature of the edge 23.
• 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 pushing element 29 comprises (more precisely is) a spring (helical) .
• 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.
• 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.
• 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.
• 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.

Applications Claiming Priority (2)

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• 2015
  • 2015-11-27 EA EA201791172A patent/EA033905B1/ru not_active IP Right Cessation
  • 2015-11-27 EP EP15823767.7A patent/EP3223715A1/de not_active Withdrawn
  • 2015-11-27 WO PCT/IB2015/059182 patent/WO2016084047A1/en active Application Filing

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