Improved biopsy device

Abstract

The biopsy needle device (20) comprises a needle sheath (22) and a needle (21) configured to lock the needle tip portion (23) relative to the sheath when the needle device attains a closed state. The locking between the needle tip portion and the sheath, achieved by the configuration of the sheath opening edge and proximal tip edge, is in a third direction Z and in a rotational sense in that the tip cannot rotate about a longitudinal axis defined by the first direction X.

Description

[Technical Field]

[0001] SUMMARY OF THE INVENTION Embodiments herein relate to a needle device for performing a soft tissue biopsy. [Background technology]

[0002] In the medical field, needle devices exist for various purposes, such as for obtaining biopsy samples. In addition to the needle device, a biopsy sample collection device typically also includes some type of actuator device that facilitates an operator to push the biopsy needle into tissue and remove a biopsy sample from the tissue. Naturally, a key concern when performing a biopsy sample collection is protecting the patient from accidental injury and minimizing the risk of infection.

[0003] Prior art biopsy needle devices (commonly referred to as "tru cut" needle devices) have the disadvantage that they collect a large amount of tissue on their way to the target site within the patient's body where the actual biopsy tissue sample is to be obtained. During insertion, the biopsy needle device will often encounter sites where bacteria are present, and these bacteria are often carried to a site where they run the risk of causing an infection.

[0004] These problems have typically been addressed through the use of antibiotics, but with the rise in antibiotic resistance, this chemical approach to addressing the problem has become less effective, requiring different technological solutions. Summary of the Invention [Problem to be solved by the invention]

[0005] In light of the above, it is an object of the present disclosure to overcome the shortcomings associated with prior art biopsy needle devices. [Means for solving the problem]

[0006] In one aspect, such object is to provide a biopsy needle device comprising: - a needle sheath having a proximal end and a distal end, the needle sheath being a hollow tube elongated along a first direction X with a sheath opening at the distal end of the needle sheath; a needle sheath, the sheath opening being bounded by a first sheath opening edge defining a first plane and a second sheath opening edge defining a second plane, the first plane and the second plane intersecting each other at an angle A along a first line of intersection; a needle having a proximal end and a distal end, the needle comprising: a shaft portion elongated along a first direction X configured to fit inside a needle sheath and slide relative to the needle sheath; a tip portion coupled to the shaft portion and positioned at the distal end of the needle; and a cavity formed by the shaft portion and extending in the first direction X, a second direction Y perpendicular to the first direction X, and a third direction Z perpendicular to the first direction X and the second direction Y; a needle, wherein the tip portion has a distal tip, a first proximal tip edge defining a third plane, and a second proximal tip edge defining a fourth plane, the third plane and the fourth plane intersecting each other at an angle A along a second intersection line; Equipped with - achieved by a biopsy needle device configured such that the needle device is in a closed state in which the first sheath opening edge abuts the first proximal tip edge, the second sheath opening edge abuts the second proximal tip edge, and the first intersection line coincides with the second intersection line.

[0007] Such a biopsy needle device advantageously differs from prior art biopsy needle devices in that it is configured to lock the needle tip relative to the sheath when the needle device achieves a closed state. The lock between the needle tip and the sheath is achieved in a third direction Z and in a rotational sense, in that the tip cannot rotate about a longitudinal axis defined by the first direction X. The lock ensures that no gap exists between the proximal end of the tip and the sheath opening when the edge of the sheath opening is moved distally (here, in the first direction X) to excise a tissue sample contained in the cavity. By avoiding a gap between the proximal end of the tip and the sheath opening, the needle device of the present disclosure minimizes bacterial capture during the biopsy procedure, as discussed above. The locking feature also allows for multiple biopsies while maintaining optimal closure of the needle device.

[0008] The sheath opening edge may be configured to prevent the first intersection line from passing through the cavity at all positions of the first intersection line along the first direction X during relative sliding between the needle shaft portion and the sheath. Further, the cavity within the needle may be bounded by at least a cavity lower portion having a lowest bottom surface in a third direction, and the first intersection line passes below the lowest bottom surface of the cavity lower portion in the third direction during relative sliding between the needle shaft portion and the sheath. Furthermore, the second sheath opening surface may have an extension in the second direction Y that is equal to or shorter than the extension of the cavity lower portion in the second direction Y.

[0009] That is, this configuration is stable in that it minimizes any undesired movement in the third direction Z while the needle and sheath are moving along the first direction X during a biopsy procedure. This avoids the risk of the biopsy tissue being lifted out of the cavity by the second sheath opening edge during forward movement. With the second sheath opening edge below the bottom surface of the cavity, the biopsy tissue is pushed into the cavity by the first sheath opening edge and remains there. If the second sheath opening edge were configured at a higher plane relative to the bottom surface of the cavity, the second sheath opening edge would provide an upward force that would increase the risk of lifting the biopsy tissue upward. The combination of the upward and downward forces would result in a forward pushing force, which would result in insufficient filling of the cavity and therefore poor biopsy quality. It has been found that by configuring the second sheath opening edge with the same lateral limit or width as the needle in the plane defined by the first direction X and the second direction Y, as viewed along the third direction, i.e., from above, the lifting force acting on the biopsy tissue within the cavity is eliminated and therefore has no negative impact on biopsy quality.

[0010] The cavity within the needle may be bounded by at least a distal cavity wall and a proximal cavity wall, the distal cavity wall configured with a distal cavity wall angle relative to the first direction, and the first sheath opening edge configured with a first sheath opening edge angle relative to the first direction X that is equal to or less than the distal cavity wall angle.

[0011] This configuration allows for efficient shearing of tissue embedded in the cavity as the sheath is moved distally in the first direction X during a biopsy procedure. This angular relationship ensures a clean shear as the first opening edge of the sheath passes through the distal cavity wall during movement along the first direction X during a biopsy procedure.

[0012] The second sheath opening edge may be configured with a second sheath opening edge angle relative to the first direction X that is greater than zero. For example, it has been found that configuring the second sheath opening edge at an angle in the range of 90° to 150° eliminates lifting forces acting on the biopsy tissue within the cavity and therefore has no negative impact on biopsy quality.

[0013] The hollow tube of the sheath and the sheath opening may have a circular cross-section in the plane defined by the second direction Y and the third direction Z, the shaft portion of the needle may have a circular cross-section in the plane defined by the second direction Y and the third direction Z, and the tip portion of the needle may have a circular cross-section in the plane defined by the second direction Y and the third direction Z.

[0014] That is, an overall or generally circular cross section of the biopsy needle device in the plane defined by the Y and Z directions is advantageous in that it is easy to manufacture.

[0015] The tip portion can include a first surface, a second surface, and a third surface, each surface configured to converge toward a distal tip, such that during use in a biopsy procedure, in a left-handed orientation of a first direction X, a second direction Y, and a third direction Z, the first surface is configured to push the tip portion opposite to or against the third direction Z, the second surface is configured to push the tip portion in or along the second direction and in the third direction Z, and the third surface is configured to push the tip portion opposite to or against the second direction Y and in or along the third direction Z.

[0016] In other words, in such embodiments, the tip portion may be understood to have a "plow" configuration, which is advantageous in view of prior art biopsy needle devices.

[0017] Many prior art needle devices "dive" during a biopsy procedure, i.e., the needle tip is pushed downward into the tissue while the needle is moving forward. This can be beneficial in terms of the amount of biopsy tissue obtained, as the lower cavity is pushed upward as the sheath is moved forward, and at the same time the distal end of the sheath pushes downward on the tissue. However, it has been recognized that this has a significant drawback, as the biopsy needle may miss the biopsy target, and therefore the tissue obtained comes from a point below the target.

[0018] With the "plows" forming the first, second, and third surfaces of the tip portion distributing the forces acting on the tip more evenly, the forward movement of the needle in the first direction will have a linear character and therefore will better hit the biopsy target. Although such a configuration may result in slightly less tissue being acquired, the three-sided configuration causes the needle to move a very short distance downward in the third direction Z, optimizing in that the first surface faces upward in the third direction, thereby driving tissue upward in the third direction as the needle moves forward, thereby filling the cavity with tissue.

[0019] In other embodiments, the tip portion may comprise a distal cone terminating in a distal tip, the distal cone configured such that the distal tip is offset relative to the central axis L in a third direction Z along the first direction X such that during use in a biopsy procedure, in a left-handed orientation in the first direction X, the distal cone pushes against or against the tip portion in the third direction Z.

[0020] The conical tip configuration provides the same advantageous motion outlined above in connection with embodiments having a "plow configuration." Furthermore, because the conical tip configuration lacks a cutting edge, allowing the needle to displace nerves (i.e., laterally) when positioned prior to initiating forward motion, minimizing the risk of shearing nerve tissue, the conical tip configuration advantageously allows the needle tip to pass through nerve tissue less traumatically during forward motion. For example, a biopsy needle device having a conical tip can be advantageously used in biopsy procedures involving the spinal cord, i.e., at least vital nerve tissue. The conical tip configuration achieves this advantage while simultaneously achieving the advantages discussed above in connection with the "plow" configuration, which improves cavity filling and provides a slight downward motion. For example, by configuring the distal tip to be offset an appropriate distance below the central axis L along the first direction X and against the third direction Z, deflection of the distal tip in the third direction during needle movement in the first direction X, i.e., during a stroke, can be controlled to a desired small deflection. Furthermore, the tip should be configured to be sufficiently sharp so that it can pass atraumatically through, for example, nerve tissue during the first step of insertion into the body and then while cutting the tissue as it quickly passes through the tissue to be subjected to biopsy sampling. [Brief explanation of the drawings]

[0021] [Figure 1] Figure 1a is a schematic side view of a biopsy needle device in an open state, Figure 1b is a schematic side view of a biopsy needle device in a closed state, Figure 1c is a schematic side view of the distal end of the biopsy needle device, and Figure 1d is a schematic side view of the distal end of the biopsy needle device. [Figure 2] Figure 2a is a schematic side view of the tip portion of a biopsy needle device, Figure 2b is a schematic top view of the tip portion of a biopsy needle device, Figure 2c is a schematic perspective view of the tip portion of a biopsy needle device, Figure 2d is a schematic side view of the tip portion of a biopsy needle device, and Figure 2e is a schematic perspective view of the tip portion of a biopsy needle device. [Figure 3] Figure 3a is a schematic side view of a needle sheath of a biopsy needle device, Figure 3b is a schematic bottom view of a needle sheath of a biopsy needle device, and Figure 3c is a schematic perspective view of a needle sheath of a biopsy needle device. DETAILED DESCRIPTION OF THE INVENTION

[0022] 1a-1d, 2a-2c, and 3a-3c, biopsy needle device 20 will now be illustrated, with reference to individual features, all of which will have the same reference numeral throughout the referenced figures.

[0023] Biopsy needle device 20 includes needle sheath 22 having proximal end 201 and distal end 202. Needle sheath 22 is an elongated hollow tube extending along first direction X with sheath opening 203 at distal end 202 of needle sheath 22. Sheath opening 203 is bounded by first sheath opening edge 51, which defines first plane 151, and second sheath opening edge 52, which defines second plane 152. First plane 151 and second plane 152 intersect each other at angle A along first intersection line 153.

[0024] Biopsy needle device 20 further includes needle 21 having proximal end 211 and distal end 212. Needle 21 includes a shaft portion 213 elongated along a first direction X and configured to fit inside and slide relative to needle sheath 22. Tip portion 23 is coupled to shaft portion 213 and positioned at distal end 212 of needle 21. Shaft portion 213 defines a cavity 30 that extends in first direction X, a second direction Y perpendicular to first direction X, and a third direction Z perpendicular to first direction X and second direction Y.

[0025] Tip portion 23 has a distal tip 24 and a first proximal tip edge 61 that defines a third plane 161 and a second proximal tip edge 62 that defines a fourth plane 162. Third plane 161 and fourth plane 162 intersect each other at angle A along a second intersection line 163.

[0026] The needle device 20 is configured to be in a closed state in which the first sheath opening edge 51 abuts the first proximal tip edge 61, the second sheath opening edge 52 abuts the second proximal tip edge 62, and the first intersection line 153 coincides with the second intersection line 163.

[0027] A biopsy procedure using the biopsy needle device 20 described herein involves a series of steps that move the needle 21 and needle sheath 22 relative to each other and relative to the body, e.g., a human or animal body, that is to be subjected to the biopsy procedure. The actual movement of the needle 21 and needle sheath 22 may be actuated by any suitable actuator device. It should be noted that any detailed description of such actuator devices is beyond the scope of this disclosure.

[0028] Initially, the biopsy needle device 20 is in the closed state illustrated in FIG. 1b. In a first movement step, the biopsy needle device 20 is inserted into the body to be subjected to the biopsy procedure. In a second movement step, the needle 21 moves forward along the first direction X, penetrating the tissue to be biopsied. The forward movement of the needle 21 stops a desired distance into the tissue, at which point the biopsy needle device 20 assumes the open state illustrated in FIG. 1a. At this point, the cavity 30 becomes filled with tissue. In a third movement step, the needle sheath 22 moves forward along the first direction X until the biopsy needle device 20 again assumes the closed state in which the first sheath opening edge 51 abuts the first proximal tip edge 61, the second sheath opening edge 52 abuts the second proximal tip edge 62, and the first intersection line 153 coincides with the second intersection line 163. During this third movement step, the needle sheath 22 performs a cutting action such that the tissue becomes contained inside the cavity 30. A fourth movement step then involves retracting the biopsy needle device 20 rearward along the first direction X, thereby completing the biopsy procedure without the drawbacks associated with prior art biopsy devices.

[0029] lb, the needle 21 has a length LN that is longer than the length LS of the needle sheath 22. The first intersection line 153 may be transverse or perpendicular to the first direction X. The first sheath opening edge 51 may face or conform to the first proximal tip edge 61. The second sheath opening edge 52 may face or conform to the second proximal tip edge 62 in the closed state.

[0030] Angle A may be less than 180° and / or may be in the range of 120°-180°, 100°-120°, 80°-100°, or 60°-80°. It has been found that the range of 80°-100° is advantageous for centering needle tip 24, while a 90° angle is advantageous for simplifying the manufacturing procedure for creating angle A, for example, by milling or cutting. In other words, angle A may be a right angle or an obtuse angle. A right angle provides a good balance between centering and locking capabilities during closure, while an obtuse angle provides a stronger locking capability. Furthermore, it is specified that first plane 151 and second plane 152 intersect each other at angle A. In this context, explicitly defined angles or intervals of angles should be considered approximate.

[0031] The extension of the cavity 30 as defined above may be such that the cavity 30 has a length in a first direction X, a width in a second direction Y and a height in a third direction Z.

[0032] As illustrated in the figure, the sheath opening 203 is bounded by a first sheath opening surface 53 comprising a first sheath opening edge 51 and a second sheath opening surface 54 comprising a second sheath opening edge 52. Surfaces 53, 54 may have an extension relative to the wall thickness of the hollow tube of sheath 22. However, the extension of surfaces 53, 54 may be minimized as much as possible by a sharpening step during manufacturing so that edges 51, 52 are sharp edges.

[0033] As illustrated in the figure, the tip portion 23 has a first proximal tip surface 63 with a first proximal tip edge 61 and a second proximal tip surface 64 with a second proximal tip edge 62.

[0034] The sheath opening edges 51, 52 are configured to prevent the first intersection line 153 from passing through the cavity 30 at all positions of the first intersection line 153 along the first direction X during relative sliding between the needle shaft portion 213 and the sheath 22.

[0035] In other words, the configuration of the sheath opening edges 51, 52 to prevent the first intersection line 153 from passing through the cavity 30 is understood to include the first intersection line 153 and the cavity 30 being separated, spaced apart, or forming a separation distance laterally relative to the first direction X in the closed state.

[0036] As shown, the cavity 30 within the needle 21 is bounded by at least a lower cavity portion 222 having a lowest bottom surface in the third direction Z. In this case, the first intersection line 153 passes below the lowest bottom surface of the lower cavity portion 222 in the third direction Z during relative sliding between the needle shaft portion 213 and the sheath 22.

[0037] In other words, the fact that first intersection line 153 passes below the lowest bottom surface of lower cavity portion 222 in third direction Z is understood to encompass that first intersection line 153 and cavity 30 or the lowest bottom surface of lower cavity portion 222 are separated, spaced apart, or form a separation distance in third direction Z in the closed state. Furthermore, as exemplified herein, an advantageous embodiment is one in which the width or extension of second sheath opening surface 54 in second direction Y is equal to or less than the width or extension of lower cavity portion 222 in second direction Y. Such a configuration minimizes lifting forces, i.e., forces acting upward in third direction Z, during movement of the needle device during a biopsy procedure.

[0038] As illustrated, the intersection lines 153, 163 are parallel to the second direction Y. In such a case, the first plane 151, the second plane 152, the third plane 161, and the fourth plane 162 can have respective orientations or angles with respect to the first direction X as follows: The first plane 151 and the third plane 161 can have an angle 154 with respect to the first direction X in the interval 10° to 45°, and the second plane 152 and the fourth plane 162 can have an angle 155 with respect to the first direction X in the interval 90° to 150°. Furthermore, since, as discussed above, an advantageous value for the intersection angle A is 90°, this means that, given these intervals for given angles 154, 155, there are corresponding advantageous values ​​for the angles 154, 155 of the planes 151, 152, 161, 162 with respect to the first direction X. For example, the table below shows three sets of such advantageous angles:

[0039] [Table 1]

[0040] As shown in FIG. 1c, shaft portion 213 includes an intermediate portion 214 between cavity 30 and tip portion 23, which is positioned inside and conforms to needle sheath 22 in the closed state. Such intermediate portion has an extension in a first direction to enable sheath opening edges 51, 52 to cut tissue cleanly into cavity 30 during a forward movement that cuts a tissue sample into cavity 30. Removal of tissue from cavity 30 may be facilitated by the presence of such intermediate portion 214. However, alternative configurations of needle device 20 may lack such intermediate portion 214, whereby cavity 30 terminates flush with proximal tip edge 61.

[0041] Cavity 30 within needle 21 is bounded by at least distal cavity wall 220 and proximal cavity wall 221. Distal cavity wall 220 is configured with a distal cavity wall angle 230 relative to first direction X, and first sheath opening edge 51 is configured with a first sheath opening edge angle 154 relative to first direction X that is equal to or less than distal cavity wall angle 230. This configuration between distal cavity wall 220 angle 230 and first sheath opening edge angle 154 enables sheath opening edges 51, 52 to cleanly cut tissue into cavity 30 during forward movement that cuts a tissue sample into cavity 30.

[0042] It has been found that a beneficial limit for distal cavity wall 220 angle 230 is 45° (although angles in the range 45°-60° may also be beneficial), which is roughly independent of first sheath opening edge angle 154. Such an angle mitigates any effects of accidental collision between first sheath opening edge 51 and distal cavity wall 220 during forward movement of sheath 22.

[0043] The second sheath opening edge 52 is configured with a second sheath opening edge angle 155 relative to the first direction X that is greater than zero. Advantageous values ​​for the second sheath opening edge angle 155 are exemplified above.

[0044] As illustrated in the figure, the hollow tube of the sheath 22 and the sheath opening 203 have a circular cross-section in the plane defined by the second direction Y and the third direction Z, the shaft portion 213 of the needle 21 has a circular cross-section in the plane defined by the second direction Y and the third direction Z, and the tip portion 23 of the needle 21 has a circular cross-section in the plane defined by the second direction Y and the third direction Z. However, other Y / Z cross-sections, such as elliptical cross-sections, are not excluded.

[0045] The tip portion 23 has an extension DT in the plane defined by the second direction Y and the third direction Z, which is greater than or equal to the lateral extension DS of the sheath opening 203 in the plane defined by the second direction Y and the third direction Z.

[0046] Additionally or alternatively, at each point where the first sheath opening edge 51 abuts the first proximal tip edge 61 in the closed state, the tip portion 23 can have a radial extension greater than or equal to the corresponding extension of the sheath opening 203. Similarly, at each point where the second sheath opening edge 52 abuts the second proximal tip edge 62 in the closed state, the tip portion 23 can have a radial extension greater than or equal to the corresponding extension of the sheath opening 203. Here, radial extension is understood to be relative to the first direction X or to lie in a plane defined by the second direction Y and the third direction Z.

[0047] In other words, the outside of the biopsy needle device 20 should be as smooth as possible, which means that the associated parts (sheath 22 and tip portion 23) should advantageously have the same diameter. However, from a manufacturing standpoint, the tolerances on the extensions of the parts should be such that the tip portion 23 has a larger extension. This is because, as opposed to a configuration in which the sheath 22 has a larger extension than the tip portion 23, this relationship reduces the risk of collecting foreign matter, such as bacteria, during the first step of the biopsy procedure (as described above) and also reduces the risk of collecting bacteria during repeated passes. However, ideally, the parts would have the same diameter and a perfect fit. The parts should fit together perfectly in the closed state and when pressed together.

[0048] 1a-1d and 2a-2c, tip portion 23 includes first surface 251, second surface 252, and third surface 253. Respective surfaces 251, 252, 253 are configured to converge toward distal tip 24, such that during use in a biopsy procedure, in a left-handed orientation of first direction X, second direction Y, and third direction Z, first surface 251 is configured to push tip portion 23 opposite to or against third direction Z, second surface 252 is configured to push tip portion 23 in or along second direction Y and in third direction Z, and third surface 253 is configured to push tip portion 23 opposite to or against second direction Y and in or along third direction Z.

[0049] Such a configuration provides biopsy needle device 20 with a plow character that more evenly distributes forces acting on tip portion 23, and the "plow" formed by first surface 251, second surface 252, and third surface 253 of tip portion 23 causes forward movement of needle 21 in first direction X to have a linear character, thereby better hitting the biopsy target. While such a configuration may result in slightly less tissue being acquired, the three-sided configuration causes needle 21 to move in a linear fashion, or only a short distance downward relative to third direction Z, with the optimization being that first surface 251 points upward in third direction Z, forming an acute angle 261 with first direction X, thereby driving tissue upward in third direction Z as needle tip portion 23 moves forward in first direction X, thereby filling cavity 30 with tissue.

[0050] A variation of the examples of Figures 1a-1d and 2a-2c could be a tip portion with a greater number of faces, for example a tip configuration with one face similar to first face 251 and three or more faces forming a "plow" shape in a manner similar to second face 252 and third face 253.

[0051] Another alternative configuration of tip portion 23 is illustrated in Figures 2d and 2e. In other words, biopsy needle device 20 can include tip portion 23 comprising a distal cone 25 that terminates in a distal tip 24. Such distal cone 25 may be configured such that distal tip 24 is offset relative to central axis L in a third direction Z along first direction X, such that during use in a biopsy procedure, in a left-handed orientation in first direction X, distal cone 25 pushes tip portion 23 opposite or against third direction Z.

[0052] Such a configuration provides biopsy needle device 20 with a cutting characteristic similar to the "plow" configuration described above. For example, by configuring the distal tip to be offset along first direction X, against third direction Z, an appropriate distance OD below central axis L, the deflection of the distal tip during needle movement in first direction X, i.e., over a stroke of, for example, 2 cm, may be less than 1 mm, which is a typical acceptable or desired deflection.

Claims

1. A biopsy needle device (20), comprising: a needle sheath (22); a needle (21); the needle sheath (22) has a proximal end (201) and a distal end (202); The needle sheath (22) is an elongated hollow tube along a first direction (X) having a sheath opening (203) at the distal end (202) of the needle sheath (22); the sheath opening (203) is bounded by a first sheath opening edge (51) defining a first plane (151) and a second sheath opening edge (52) defining a second plane (152), the first plane (151) and the second plane (152) intersecting each other at an angle (A) along a first intersection line (153); The needle (21) has a proximal end (211) and a distal end (212); The needle (21) comprises a shaft portion (213) elongated along the first direction (X) configured to fit inside the needle sheath (22) and slide relative to the needle sheath (22), a tip portion (23) connected to the shaft portion (213) and positioned at the distal end (212) of the needle (21), and a cavity (30) formed by the shaft portion (213) and extending in the first direction (X), a second direction (Y) perpendicular to the first direction (X), and a third direction (Z) perpendicular to the first direction (X) and the second direction (Y), the tip portion (23) has a distal tip (24), a first proximal tip edge (61) defining a third plane (161), and a second proximal tip edge (62) defining a fourth plane (162), the third plane (161) and the fourth plane (162) intersecting each other at the angle (A) along a second intersection line (163); the biopsy needle device (20) is configured to be in a closed state in which the first sheath opening edge (51) abuts the first proximal tip edge (61), the second sheath opening edge (52) abuts the second proximal tip edge (62), and the first intersection line (153) coincides with the second intersection line (163); the first sheath opening edge (51) and the second sheath opening edge (52) are configured to prevent the first intersection line (153) from passing through the cavity (30) at all positions of the first intersection line (153) along the first direction (X) during relative sliding between the shaft portion (213) and the needle sheath (22). A biopsy needle device (20).

2. the sheath opening (203) is bounded by a first sheath opening surface (53) comprising the first sheath opening edge (51); the sheath opening (203) is bounded by a second sheath opening surface (54) comprising the second sheath opening edge (52); The biopsy needle device (20) of claim 1.

3. the tip portion (23) comprises a first proximal tip surface (63) comprising the first proximal tip edge (61); the tip portion (23) comprises a second proximal tip surface (64) comprising the second proximal tip edge (62); A biopsy needle device (20) according to claim 1 or 2.

4. The cavity (30) inside the needle (21) is bounded by at least a cavity lower portion (222) having a lowest bottom surface in the third direction (Z), the first intersection line (153) passes below the lowest bottom surface of the lower cavity portion (222) in the third direction (Z) during relative sliding between the shaft portion (213) and the needle sheath (22); The biopsy needle device (20) of claim 1.

5. A biopsy needle device (20) as described in any one of claims 1 to 4, wherein the first intersection line (153) and the second intersection line (163) are parallel to the second direction (Y).

6. The sheath opening (203) is bounded by a second sheath opening surface (54) comprising the second sheath opening edge portion (52); the cavity (30) inside the needle (21) is bounded by at least a cavity lower portion (222) having a lowest bottom surface in the third direction (Z); 2. The biopsy needle device of claim 1, wherein the second sheath opening surface has an extension in the second direction that is equal to or shorter than an extension of the lower cavity portion in the second direction.

7. A biopsy needle device (20) as described in any one of claims 1 to 6, wherein the shaft portion (213) has an intermediate portion (214) between the cavity (30) and the tip portion (23), and the intermediate portion (214) is positioned inside the needle sheath (22) in the closed state and has a shape that matches the needle sheath (22).

8. The needle (21) of claim 1, wherein the cavity (30) within the needle (21) is bounded by at least a distal cavity wall (220) and a proximal cavity wall (221), the distal cavity wall (220) being configured with a distal cavity wall angle (230) relative to the first direction (X); the first sheath opening edge (51) is configured with a first sheath opening edge angle (154) relative to the first direction (X) that is equal to or less than the distal cavity wall angle (230); A biopsy needle device (20) according to any one of claims 1 to 7.

9. The second sheath opening edge (52) is configured with a second sheath opening edge angle (155) relative to the first direction (X) that is greater than zero, or is in the range of 0° to 150°, or is in the range of 90° to 150°. A biopsy needle device (20) according to any one of claims 1 to 8.

10. The hollow tube of the needle sheath (22) and the sheath opening (203) have a circular cross section in a plane defined by the second direction (Y) and the third direction (Z); the shaft portion (213) of the needle (21) has a circular cross section in the plane defined by the second direction (Y) and the third direction (Z); The tip portion (23) of the needle (21) has a circular cross section in the plane defined by the second direction (Y) and the third direction (Z). A biopsy needle device (20) according to any one of claims 1 to 9.

11. A biopsy needle device (20) as described in any one of claims 1 to 10, wherein the tip portion (23) has an extension portion (DT) in a plane defined by the second direction (Y) and the third direction (Z), and the extension portion (DT) is greater than or equal to a lateral extension portion (DS) of the sheath opening (203) in the plane defined by the second direction (Y) and the third direction (Z).

12. The tip portion (23) comprises a first surface (251), a second surface (252), and a third surface (253), each surface (251, 252, 253) configured to converge towards the distal tip (24), and during use in a biopsy procedure, in a left-handed orientation of the first direction (X), the second direction (Y), and the third direction (Z), the first surface (251) converges towards the distal tip (24) in a direction opposite or against the third direction (Z). the second surface (252) is configured to press the tip portion (23) in or along the second direction (Y) and in the third direction (Z), and the third surface (253) is configured to press the tip portion (23) opposite or against the second direction (Y) and in or along the third direction (Z). A biopsy needle device (20) according to any one of claims 1 to 11.

13. The tip portion (23) comprises a distal cone portion (25) terminating in the distal tip (24), the distal cone portion (25) being configured such that the distal tip (24) is offset relative to the central axis (L) in the third direction (Z) along the first direction (X), such that during use in a biopsy procedure, in a left-handed orientation in the first direction (X), the distal cone portion (25) pushes against or against the third direction (Z), the tip portion (23); A biopsy needle device (20) according to any one of claims 1 to 11.

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