SE542183C2 - Biopsy instrument - Google Patents

Abstract

The disclosure relates to a biopsy instrument comprising a handle (10) having a front portion (11), a rear portion (12), and at least one bridging portion (13, 13a, 13b) fixedly connecting the front portion (11) to the rear portion (12), the instrument further comprising an outer tubular rigid needle (20) having a distal end (21), intended to be inserted into tissue from which it is intended to retrieve a biopsy sample, and extending along a longitudinal direction (L) from the front portion (11) of the handle (10) to the distal end (21), and an inner drill member (30) being rotatably (R) and longitudinally slidably (S) arranged inside the outer tubular rigid needle (20), wherein the outer tubular rigid needle (20) is fixedly supported by the front portion (11).

Description

BIOPSY INSTRUMENT Field of invention The invention relates to a biopsy instrument. The biopsy instrument is especially suitable for taking tissue samples of the type often referred to as core needle biopsies.

Technical Background Core needle biopsy instruments have been used for decades for retrieving tissue samples for diagnostics and deciding treatment in various applications, such as sampling breast, prostate, lung, soft tissue, bone, thyroid, liver, pancreas and head, neck tumors, lymphnodes and salivary glands.

One commonly used kind of core needle biopsy instrument may be represented by the ProMag and BardMagnum biopsy guns marketed by Möller Medical GmbH. In this kind of instruments, a needle is spring-loaded in a handle. The physician taking the sample will position the gun in the correct position and optionally also adjust the intended penetration depth. The needle is fired by releasing the spring-load and the needle is advanced the set length relative to the handle.

One problem with this kind of instrument is that it may be difficult to set a correct penetration depth. The needle will almost no matter what be extended the pre-set penetration depth and if the penetration depth is set incorrectly, the needle may not reach the intended sample position at all or, which often is even worse, the needle may penetrate too deep into the patient’s body thereby risking to damage underlying tissue. Even if sophisticated image guidance is used, such as CT, Ultrasound or MRI, it is still difficult to precisely guide the needle to the correct sampling depth or avoid damaging underlying sensitive structures. For some critically located lesions it is therefore not possible to use a standard core needle biopsy due to the risk of damaging vital structures or as it is too small to precisely sample even under image guidance. Moreover, it has been found that if the needle hits something that is too hard (such as some kinds of tumours), the needle end may be bent into a hook like shape or even break in an uncontrolled manner. There is a significant risk that the tissue is severely damaged when such an uncontrolledly formed hook is retracted from the patient’s body.

When it comes to retrieving samples from bone a different kind of instrument, as so-called bone core needle biopsy instrument, is often used. This kind of instrument may e.g. be represented by Ostycut instrument marketed by Bard Biopsy Systems. This instrument involves the use of a twopart needle and a syringe for specimen retrieval. The instrument is complicated to use and requires a number of actions to be performed when changing the different parts of the instrument while the needle is kept inserted into the patient’s body. This may cause discomfort or even harm to the patient.

Thus, there is a need for an improved biopsy instrument. The biopsy instrument should preferably be designed to be able to be used in various medial indications. The biopsy instrument should preferably be designed to be used with a minimal number of actions to be performed by the physician; especially with a minimal number of actions to be performed while the needle is kept inserted into the patient’s body.

Summary of invention It is an object of the invention to provide a biopsy instrument which may be used in various medical indications and which is simple to use by the physician retrieving the tissue sample.

This object has been achieved by a biopsy instrument comprising a handle having a front portion a rear portion, and at least one bridging portion fixedly connecting the front portion to the rear portion, the biopsy instrument further comprising an outer tubular rigid needle having a distal end, intended to be inserted into tissue from which it is intended to retrieve a biopsy sample, and extending along a longitudinal direction from the front portion of the handle to the distal end, and an inner drill member being rotatably and longitudinally slidably arranged inside the outer tubular rigid needle, wherein the outer tubular rigid needle is fixedly supported by the front portion, wherein the front portion has a rearward facing abutment surface with a mouth through which the inner drill member extends into the front portion and into the outer tubular rigid needle, wherein the rear portion has a forward facing abutment surface with a mouth through which the inner drill member extends into a tubular channel in the rear portion of the handle, wherein the inner drill member extends, as seen in a direction opposite the longitudinal direction, inside the outer tubular rigid member, out of the mouth in the rearward facing abutment surface, alongside the bridging portion and into the tubular channel in the rear portion, wherein the inner drill member comprises, at a portion of the inner drill member extending longitudinally alongside the bridging portion, a manoeuvring portion allowing a user to longitudinally slide the inner drill member relative to the handle and the outer tubular rigid needle and to rotate the inner drill member a plurality of revolutions about the longitudinal axis relative to the handle and the outer tubular rigid needle, wherein the manoeuvring portion has a radial extension in a radial direction being transverse to the longitudinal direction, the radial extension being greater than the mouth in the rearward facing abutment surface, whereby direct or indirect abutment of the manoeuvring portion with the rearward facing abutment surface defines a maximum forward position of the inner drill member relative to the outer tubular rigid needle in which maximum forward position the inner drill member extends a distance out of the distal end and in which maximum forward position the inner drill member still extends into the rear portion of the handle, wherein the radial extension of the manoeuvring portion is greater than the mouth in the forward facing abutment surface, whereby direct or indirect abutment of the manoeuvring portion with the forward facing abutment surface defines a maximum rearward position of the inner drill member relative to the outer tubular rigid needle in which maximum rearward position the inner drill member is retracted inside the outer tubular rigid needle and in which maximum rearward position a rearward end of the inner drill member is still positioned inside the rear portion of the handle.

With this design of the biopsy instrument, the physician may insert the needle to the intended sample position in a well-controlled manner, in many cases - but not necessarily - under image guidance, where after the physician may simply drill the inner drill member into the tissue to be sampled. The image guidance may e.g. be accomplished using CT, Ultrasound or MRI. The drilling motion can be visualized, and the physician has full control over the maximum penetration as the drill is gradually advanced under image guidance. Finally, the sample is retrieved and the biopsy instrument is removed by pulling the manoeuvring portion rearward, with or without simultaneous rotation, such that the inner drill member is first retracted with a tissue sample into the outer tubular rigid member and thereafter the biopsy instrument is retracted out of the patient’s body. The inner drill member in combination with the outer tubular rigid needle and the further combination of the specific provision and location of the manoeuvring portion relative to the design of the handle makes possible to retrieve samples in a well-controlled fashion from comparably soft tissue to comparably hard tissue, such as bone or some tumours. Moreover, since the inner drill member is rotated by hand (by the physician rotating the manoeuvring portion) and has an end shaped as a drill, the risk that the needle unintentionally is bent into a hook is eliminated, or at least significantly reduced. The design of the manoeuvring portion, the abutment surfaces, the mouths and the extension of the inner drill member provides a defined maximum extension of the drill member out of the outer tubular rigid needle. It also secures that there are no sharp points or edges on which the physician otherwise could cut himself. It may be noted that the term rigid is preferably intended to relate to the fact that a member being said to be rigid has a sufficient strength against being bent such that a free length of the member may as such be inserted to the sample site; thus preferably without the need for any additional support of guidance. As mentioned above, the abutment between the manoeuvring portion and the rear ward respectively forward facing abutment surfaces may be direct or indirect. It may e.g. be indirect by the provision of a distance adjusting member. It may also be indirect by the provision of a member being sandwiched between the manoeuvring portion and any of the abutment surfaces. Such a member may e.g. be used to provide additional functionalities, such as reducing friction, providing guidance, etc.

The outer tubular rigid needle and the inner drill member may be designed in different dimensions, lengths and diameters, to suit access to different organs as well as compatibility with standard biopsy guidance devices used together with e.g. ultrasound devices.

The outer tubular rigid needle may have a rear end being positioned in flush with the rearward facing abutment surface or closer to the distal end than the rearward facing abutment surface, the rear end preferably being positioned inside the front portion. This secures that the physician will not come into contact with the rear end of the outer tubular rigid needle and thereby the risk for injuries is reduced.

The manoeuvring portion may be fixedly attached to the inner drill member. Thereby the physician is provided with a tactile feedback truly reflecting the forces encountered by and transmitted to the inner drill member.

The manoeuvring portion may comprise a knob attached to the inner drill member. This facilitates the physicians manoeuvring of the inner drill member.

The knob may be shaped as a wheel with the longitudinal direction coinciding with a rotational axis of the wheel. This facilitates the physicians manoeuvring of the inner drill member. It especially makes it easy for the physician to rotate the inner drill member several revolutions.

The biopsy instrument may further comprise a distance adjusting member being positioned at least partly between the manoeuvring portion and the rearward facing abutment surface. Abutment between the manoeuvring portion and a rearward facing surface of the distance adjusting member may define said maximum forward position of the inner drill member. By providing a distance adjusting member, it makes it easier for the physician to control the maximum forward position of the inner drill member. It may be noted that the physician is still allowed to freely control the position of the manoeuvring portion and thus the position of the inner drill member between the maximum rearward position and the adjusted maximum forward position.

The distance adjusting member may be attached, preferably removably attached, to the inner drill member between the manoeuvring portion and the rearward facing abutment surface. The distance adjusting member may have a radial extension being greater than the mouth in the rearward facing abutment surface. Such a distance adjusting member may e.g. be in the form of a ring shaped member. The adjustment may e.g. be provided by removing or attaching the distance adjusting member. It may be noted that there may be provided a set of a plurality of distance adjusting members whereby the maximum position may be adjusted by changing which distance adjusting member or the number of distance adjusting members used. The distance adjusting members of the set may have the same length or have different lengths along the longitudinal direction.

The distance adjusting member may comprise two portions which may be positioned at different relative longitudinal positions, wherein one of the two portions may be configured to abut the manoeuvring portion and the other one may be configured to abut the rearward facing abutment surface. With this basic design it is possible to design the distance adjusting member to provide a step-wise adjustment and/or to design the distance adjusting member to provide a continuous adjustment.

The distance adjusting member may comprise a threaded portion being configured to be threaded into a threaded, longitudinally extending bore in the rearward facing abutment surface, and an abutment portion configured to provide a rearward facing abutment surface for interaction with the manoeuvring portion. With this basic design it is easy to design the distance adjusting member to provide a continuous adjustment.

The front portion may be divided into a first front portion supporting the outer tubular rigid needle and a second front portion comprising the rearward facing abutment surface, wherein the first and second front portions may be movable relative to each other along the longitudinal direction and may be configured to be set at different mutual longitudinal positions thereby providing different longitudinal distances between the abutment surface and the distal end of the outer tubular rigid needle. With this design it is possible to provide an adjustment of the maximum distance the inner drill member extends out of the distal end as an integral functionality of the handle.

The handle may be provided with one single bridging portion extending between and fixedly interconnecting the front and rear portions of the handle and extending alongside a portion of the inner drill member and alongside the manoeuvring portion, and wherein the manoeuvring portion is exposed between the front and rear portions of the handle and alongside the bridging portion such that a user may reach the manoeuvring portion with his/her fingers. With such a basic design it is possible to provide a handle with good accessibility to the manoeuvring portion.

The handle may comprise two bridging portions, preferably having exactly two bridging portions, extending between and fixedly interconnecting the front and rear portions of the handle and extending alongside each other on opposite sides of a portion of the inner drill member and the manoeuvring portion, and wherein the manoeuvring portion is exposed between the front and rear portions of the handle and between the two bridging portions such that a user may reach the manoeuvring portion with his/her fingers. With such a basic design there is accomplished a balance between the handle on one hand providing gripping surfaces and on the other hand exposing the manoeuvring portion.

The biopsy instrument may further comprise a retraction guidance to indicate when the inner drill member has been fully withdrawn into the outer tubular rigid needle. Thereby it is easy for the physician to know when the inner drill member and thereby the sample has been withdrawn inside the outer tubular rigid needle and thus indicating that the biopsy instrument is ready to be withdrawn from the patient’s body. It may noted that fully does not necessarily mean that the inner drill member cannot be retracted any further into the outer tubular rigid needle. Fully is in this context primarily intended to relate to the fact that when the inner drill member is fully withdrawn, it does not extend out of the outer tubular rigid needle at all.

The retraction guidance may comprise a visual indicator, such as a colour code, on the handle alongside the manoeuvring portion or on a portion of the inner drill member being exposed out of the rearward facing abutment surface. It may e.g. be indicated by the colours; green when fully withdrawn, green/red when partially withdrawn, and red when fully extended.

The retraction guidance may comprise a mechanical lock mechanism that engages when the inner drill member is fully withdrawn. This reduces the risk that the inner drill member is unintentionally pushed out of the outer tubular rigid needle when the biopsy instrument is handled after the tissue sample has been retrieved. Preferably the mechanical lock mechanism is provided with a release mechanism allowing the physician to in a controlled manner push the inner drill member out of the outer tubular rigid needle when the tissue sample is to be retrieved from the biopsy instrument for analysis. The mechanical lock mechanism is preferably designed to provide an audible and/or tactile feed-back to the physician as the physician retracts the inner drill member to an extent such that the mechanical lock mechanism is engaged. Thereby will the physician get a distinct confirmation that the inner drill member is fully withdrawn without any need for the physician to let go of his view of the patient and to look at the biopsy instrument.

The inner drill member may be made from a cylinder of surgical steel with a distal end preferably being machined into a drill. This is an efficient way of providing a strong and rigid inner drill member and a strong and rigid drill at the distal end thereof.

The drill may comprise a longitudinally extending core and a helical cutting edge being formed on a helical flange surrounding said inner core. This provides strong and rigid drill with a good drill functionality and also provides together with the outer tubular rigid needle and efficient tissue sampling and retrieval functionality. Other geometries and shapes are conceivable; especially for small dimensions.

The inner drill member may have a conically shaped distal end. This is advantageous since the drill may penetrate comparably hard tissues or bone and since it reduces the risk of the biopsy instrument unintentionally getting caught in the tissue. Further, the combination of the outer tubular rigid needle and the inner drill member functions as a needle with a mandrill preventing tissue to enter into the outer tubular rigid needle during insertion into tissue.

In short the invention may also be said to relate to a biopsy instrument comprising a handle having a front portion, a rear portion, and at least one bridging portion fixedly connecting the front portion to the rear portion, the instrument further comprising an outer tubular rigid needle having a distal end, intended to be inserted into tissue from which it is intended to retrieve a biopsy sample, and extending along a longitudinal direction from the front portion of the handle to the distal end, and an inner drill member being rotatably and longitudinally slidably arranged inside the outer tubular rigid needle, wherein the outer tubular rigid needle is fixedly supported by the front portion.

Brief description of the drawings The invention will by way of example be described in more detail with reference to the appended schematic drawings, which shows a presently preferred embodiment of the invention.

Figure 1 shows in perspective a biopsy instrument with an inner drill member extending out of a distal end of an outer tubular rigid needle.

Figure 2 is a side view of the biopsy instrument shown in figure 1. Figure 3 is an exploded view of the biopsy instrument of figure 1.

Figure 4 shows the biopsy instrument of figure 1 with the inner drill member retraced into the outer tubular rigid needle.

Figure 5 discloses the biopsy instrument of figure 1 provided with a distance adjusting member.

Figure 6 discloses a variant of the biopsy instrument of figure 1 in which a front portion of the handle is into a first portion and a second portion.

Figure 7 discloses a variant of the biopsy instrument of figure 1 in which distance adjusting member is provided.

Figure 8 discloses a variant of the biopsy instrument of figure 1 being provided with a single bridging portion.

Detailed description of preferred embodiments With reference to figures 1-3, there is disclosed a biopsy instrument generally comprising a handle 10, an outer tubular rigid needle 20, and an inner drill member 30. It may be noted that the general design of the biopsy instrument is common for the different variants shown in the drawings. The general design will be discussed in detail with reference mostly to figures 1-4 disclosing a first variant. The other variants share the same design and features unless a difference is specifically identified.

The handle 10 has a front portion 11 , a rear portion 12 and at least one bridging portion 13 fixedly connecting the front portion 11 to the rear portion 12.

The outer tubular rigid needle 20 has a distal end 21 intended to be inserted into tissue from which it is intended to retrieve a biopsy sample. The outer tubular rigid needle 20 extends along a longitudinal direction L from the front portion 11 of the handle 10 to the distal end 21. As shown in the figures, the outer tubular rigid needle 20 it at its distal end cut along an inclined line.

The inner drill member 30 is rotatably and longitudinally slidably arranged inside the outer tubular rigid needle 20 as indicated by the arrows R and S, respectively.

The outer tubular rigid needle 20 is fixedly supported by the front portion 11 of the handle 10. As e.g. shown in figure 3, the front portion 11 has a rearward facing abutment surface 11a with a mouth 11b through which the inner drill member 30 extends into the front portion 11 and into the outer tubular rigid needle 20.

The rear portion 12 has a forward facing abutment surface 12a with a mouth 12b through which the inner drill member 30 extends into a tubular channel 12c in the rear portion 12 of the handle 10.

As shown e.g. in figures 1 and 8, the inner drill member 30 extends, as seen in a direction L’ opposite the longitudinal direction L, inside the outer tubular rigid member 20, out of the mouth 11b in the rearward facing abutment surface 11a, alongside the bridging portion 13 and into the tubular channel 12c in the rear portion 12.

The inner drill member 30 comprises, at a portion 31 of the inner drill member 30 extending longitudinally alongside the bridging portion 13, a manoeuvring portion 32 allowing a user to longitudinally slide S the inner drill member 30 relative to the handle 10 and thus also relative to the outer tubular rigid needle 20 and to rotate R the inner drill member 30 a plurality of revolutions about the longitudinal axis L relative to the handle 10 and thus also relative to the outer tubular rigid needle 20.

The manoeuvring portion 32 has, as indicated in figure 1, a radial extension Re in a radial direction r being transverse to the longitudinal direction L. The radial extension Re is greater than the radial extension or size of the mouth 11b in the rearward facing abutment surface 11a.

The manoeuvring portion 32 is preferably fixedly attached to the inner drill member 30. The manoeuvring portion 32 may comprise a knob 32 attached to the inner drill member 30. In the preferred embodiments, the knob is shaped as a wheel 32 with the longitudinal direction L coinciding with a rotational axis of the wheel.

As shown in figure 1, the manoeuvring portion 32 may be moved forwardly along the longitudinal direction L into abutment with the rearward facing abutment surface 11a, whereby this abutment preferably defines a maximum forward position of the inner drill member 30 relative to the outer tubular rigid needle 20. In this maximum forward position, the inner drill member 30 extends a distance e out of the distal end 21. It may be noted that when the inner drill member 30 is in its maximum forward position, a rearward end 33 of the inner drill member 30 still extends a distance eb into the rear portion 12 of the handle 10.

The radial extension Re of the manoeuvring portion 32 is also greater than radial extension or size of the mouth 12b in the forward facing abutment surface 12a.

As shown in figure 4, the manoeuvring portion 32 may be moved rearwardly along the longitudinal direction L into abutment with the forward facing abutment surface 12a, whereby this abutment preferably defines a maximum rearward position of the inner drill member 30 relative to the outer tubular rigid needle 20. In this maximum rearward position, the inner drill member 30 is retracted inside the outer tubular rigid needle 20. It may be noted that when the inner drill member 30 is in its maximum rearward position the rearward end 33 of the inner drill member 30 is still positioned inside the rear portion 12 of the handle.

The physician may insert the needle 20 to the intended sample position in a well-controlled manner where after the physician may simply drill the inner drill member 20 into the tissue to be sampled. The retrieving of the sample and removing of the biopsy instrument may then be accomplished by pulling the manoeuvring portion 32 rearward such that the inner drill member 30 is first retracted with a tissue sample into the outer tubular rigid member 20 and thereafter the biopsy instrument is retracted out of the patient’s body.

It may be noted that the inner drill member 30 is intended to be rotated by hand (by the physician rotating the manoeuvring portion 32).

The design of the manoeuvring portion 32, the abutment surfaces 11a, 12a, the mouths 11b, 12b and the extension of the inner drill member provides a defined maximum extension e of the drill member 30 out of the outer tubular rigid needle 20. It also secures that there are no sharp points or edges on which the physician otherwise could cut himself. It may be noted that the term rigid is preferably intended to relate to the fact that a member being said to be rigid has a sufficient strength against being bent such that a free length of the member may as such be inserted to the sample site; thus preferably without the need for any additional support of guidance.

The handle 10 may, as shown in figure 8, be provided with one single bridging portion 13a extending between and fixedly interconnecting the front and rear portions 11, 12 of the handle 10. As shown in figure 8, this single bridging portion 13a extends alongside a portion 31 of the inner drill member 30 and alongside the manoeuvring portion 32, and wherein the manoeuvring portion 32 is exposed between the front and rear portions 11, 12 of the handle 10 and alongside the bridging portion 13a such that a user may reach the manoeuvring portion 32 with his/her fingers.

The handle may comprise two bridging portions, preferably having exactly two bridging portions 13a, 13b as shown in figures 1-7, extending between and fixedly interconnecting the front and rear portions 11, 12 of the handle 10 and extending alongside each other on opposite sides of a portion 31 of the inner drill member 30 and the manoeuvring portion 32, and wherein the manoeuvring portion 32 is exposed between the front and rear portions 11, 12 of the handle 10 and between the two bridging portions 13a, 13b such that a user may reach the manoeuvring portion with his/her fingers.

The outer tubular rigid needle 20 may have a rear end 23 being positioned in flush with the rearward facing abutment surface 11a or closer to the distal end 21 than the rearward facing abutment surface 11a. As indicated in figure 1, the rear end 23 is preferably being positioned inside the front portion 11. This secures that the physician will not come into contact with the rear end 23 of the outer tubular rigid needle 20 and thereby the risk for injuries is reduced.

As shown in figure 5, the biopsy instrument may further comprise a distance adjusting member 40 being positioned at least partly between the manoeuvring portion 32 and the rearward facing abutment surface 11a.

Abutment between the manoeuvring portion 32 and a rearward facing surface of the distance adjusting member 40 may define said maximum forward position of the inner drill member 30. By providing a distance adjusting member 40, it makes it easier for the physician to control the maximum forward position of the inner drill member 30. It may be noted that the physician is still allowed to freely control the position of the manoeuvring portion 32 and thus the position of the inner drill member 30 between the maximum rearward position and the adjusted maximum forward position.

The distance adjusting member 40 may, as e.g. shown in figure 5, be attached, preferably removably attached, to the inner drill member 30 between the manoeuvring portion 32 and the rearward facing abutment surface 11a. The distance adjusting member 40 may have a radial extension being greater than the mouth 11b (not visible in figure 5) in the rearward facing abutment surface 40. Such a distance adjusting member 40 may e.g. be, as shown in figure 5, in the form of a ring shaped member 40. The adjustment may e.g. be provided by removing or attaching the distance adjusting member 40. It may be noted that there may be provided a set of a plurality of distance adjusting members whereby the maximum position may be adjusted by changing which distance adjusting member or members or the number of distance adjusting members used. The distance adjusting members of the set may have the same length or have different lengths along the longitudinal direction.

The distance adjusting member may comprise two portions which may be positioned at different relative longitudinal positions, wherein one of the two portions may be configured to abut the manoeuvring portion and the other one may be configured to abut the rearward facing abutment surface. With this basic design it is possible to design the distance adjusting member to provide a step-wise adjustment and/or to design the distance adjusting member to provide a continuous adjustment.

As shown in figure 7, the distance adjusting member 40 may comprise a threaded portion 41 being configured to be threaded into a threaded, longitudinally extending bore 11c in the rearward facing abutment surface 11a, and an abutment portion 42 configured to provide a rearward facing abutment surface for interaction with the manoeuvring portion 32. With this basic design it is easy to design the distance adjusting member to provide a continuous adjustment.

As shown in figure 6, the front portion 11 may be divided into a first front portion 11’ supporting the outer tubular rigid needle 20 and a second front portion 11” comprising the rearward facing abutment surface 11a. The first and second front portions 11’, 11” may be movable relative to each other along the longitudinal direction L and may be configured to be set at different mutual longitudinal positions thereby providing different longitudinal distances between the rearward facing abutment surface 11a and the distal end 21 of the outer tubular rigid needle 20. The adjustment of the mutual longitudinal positions may e.g. be accomplished by providing an adjustment member 50 being provided with a first threaded portion 51a interacting with a bore 11’c in the first portion 11’ and a second threaded portion 51b interacting with a bore 11"c in the second portion 11”. With this design it is possible to provide an adjustment of the maximum distance e the inner drill member 30 extends out of the distal end 21 as an integral functionality of the handle 10.

With reference to e.g. figures 3, 4 and 6, the biopsy instrument may further comprise a retraction guidance 60 to indicate when the inner drill member 30 has been fully withdrawn into the outer tubular rigid needle 20. Thereby it is easy for the physician to know when the inner drill member and thereby the sample has been withdrawn inside the outer tubular rigid needle and thus indicating that the biopsy instrument is ready to be withdrawn from the patient’s body. It may noted that fully does not necessarily mean that the inner drill member cannot be retracted any further into the outer tubular rigid needle. Fully is in this context primarily intended to relate to the fact that when the inner drill member is fully withdrawn, it does not extend out of the outer tubular rigid needle at all.

The retraction guidance 60 may e.g., as shown in figure 4, comprise a visual indicator, such as a colour code 61, 62, 63 on the handle 10 alongside the manoeuvring portion 32. It may e.g. be indicated by the colours; green 63 when fully withdrawn, yellow or orange or striped green/red 62 when partially withdrawn, and red 61 when fully extended. Alternatively, or as a complement a retraction guide, e.g. in the form of visual indicator, such as a colour code 63’, 62’, may be provided on a portion of the inner drill member 30 being exposed out of the rearward facing abutment surface 11a.

The retraction guidance 60 may, as e.g. shown in figures 3 and 6, alternatively or as a complement to the visual indicator comprise a mechanical lock mechanism that engages when the inner drill member 30 is fully withdrawn. This reduces the risk that the inner drill member 30 is unintentionally pushed out of the outer tubular rigid needle 20 when the biopsy instrument is handled after the tissue sample has been retrieved. The mechanical lock mechanism may e.g. be, as shown in figure 3, in the form of a local widened portion 71 on the inner drill member 30 being configured to pass a local narrowed portion 72 of the channel 12c. In figure 6, there is disclosed another mechanical lock mechanism. A pin 71 having a shoulder portion 71a is intended to interact with an annular recess in the rearward facing surface of the manoeuvring portion 32. The pin 71 is positioned in a channel 12d such that it extends inside the rear portion 12 of the handle 10 and out of the forward facing abutment surface 12a along the longitudinal direction. The shoulder portion 71a has an extension in a direction transverse to the longitudinal direction L. The pin 71 is further provided with a manoeuvring portion 71b being accessible via a recess 12e. The pin 71 may be configured to be resiliently interacting with or be spring-loaded into engagement with the manoeuvring portion 32 when the manoeuvring portion 32 has been drawn rearwardly such that the pin 71 interacts with the recess in the rearward facing surface of the manoeuvring portion 32. The user may release the pin 71 by moving the manoeuvring portion 71 b relative to the handle 10, e.g. such that the pin 71 is slightly tilted about the axis A and thereby the shoulder portion 71a may be released from the recess in the rearward facing surface of the manoeuvring portion 32.

Thus, with such a design there is provided a mechanical lock mechanism with a release mechanism allowing the physician to in a controlled manner push the inner drill member 30 out of the outer tubular rigid needle 20 when the tissue sample is to be retrieved from the biopsy instrument for analysis. The mechanical lock mechanism is preferably designed to provide an audible and/or tactile feed-back to the physician as the physician retracts the inner drill member 30 to an extent such that the mechanical lock mechanism is engaged. Thereby will the physician get a distinct confirmation that the inner drill member 30 is fully withdrawn without any need for the physician to let go of his view of the patient and to look at the biopsy instrument.

The inner drill member may be made from a cylinder of surgical steel with a distal end 34 preferably being machined into a drill 35 (see e.g. figures 1 and 3). The drill 35 may comprise a longitudinally extending core 35a and a helical cutting edge 35b being formed on a helical flange 35c surrounding said inner core 35a. The inner drill member 30 may have a conically shaped distal end 35d.

The handle 10 may e.g. be formed of polymeric material, such as medical grade plastic, or metals, such as surgical steel, or combinations thereof. According to one embodiment, the handle 10 is formed of a polymeric material, preferably a medical grade plastic. The handle 10 may be provided with grooves, checkered pattern, or the like to provide grip. Alternatively, or as a complement thereto the handle 10 may be provided with rubber portions to provide grip.

The drill 35 may preferably have a length of about 0,5 to 15mm, preferably about 5 to 15mm. The inner drill member 30 may preferably have a length of about 5-40cm. The handle 10 has dimensions such that it is easy for the physician to get a secure grip about the handle 10. The handle 10 preferably has a length in the order of about 10-20cm. The handle 10 preferably has a width in the order of about 3-7cm. more preferably about 5cm, and a thickness of about 1-3cm, more preferably about 1cm.

Alternatively the handle 10 is roughly cylindrical with a diameter of about 2-5cm, preferably about 3cm.

It is contemplated that there are numerous modifications of the embodiments described herein, which are still within the scope of the invention as defined by the appended claims.

It may e.g. be noted that the different kinds of distance adjusting mechanisms of figures 5, 6, and 7, the different kinds of mechanical lock mechanisms of figures 3 and 6, and the different kinds of retractions guidance shown in figure 4, may be combined in any permutation thereof including all three functionalities or only two functionalities.

Claims (15)

1. Biopsy instrument comprising a handle (10) having a front portion (11), a rear portion (12), and at least one bridging portion (13, 13a, 13b) fixedly connecting the front portion (11) to the rear portion (12), an outer tubular rigid needle (20) having a distal end (21), intended to be inserted into tissue from which it is intended to retrieve a biopsy sample, and extending along a longitudinal direction (L) from the front portion (11) of the handle (10) to the distal end (21), and an inner drill member (30) being rotatably (R) and longitudinally slidably (S) arranged inside the outer tubular rigid needle (20), wherein the outer tubular rigid needle (20) is fixedly supported by the front portion (11), wherein the front portion (11) has a rearward facing abutment surface (11a) with a mouth (11b) through which the inner drill member (30) extends into the front portion (11) and into the outer tubular rigid needle (20), wherein the rear portion (12) has a forward facing abutment surface (12a) with a mouth (12b through which the inner drill member (30) extends into a tubular channel (12c) in the rear portion (12) of the handle (10), wherein the inner drill member (30) extends, as seen in a direction (U) parallel to and opposite the longitudinal direction (L), inside the outer tubular rigid needle (20), out of the mouth (11b) in the rearward facing abutment surface (11a), alongside the bridging portion (13, 13a, 13b) and into the tubular channel (12c) in the rear portion (12), wherein the inner drill member (30) comprises, at a portion (31) of the inner drill member (30) extending longitudinally alongside the bridging portion (13, 13a, 13b), a manoeuvring portion (32) allowing a user to longitudinally slide (S) the inner drill member (30) relative to the handle (10) and the outer tubular rigid needle (20) and to rotate (R) the inner drill member (30) a plurality of revolutions about the longitudinal axis (L) relative to the handle (10) and the outer tubular rigid needle (20), wherein the manoeuvring portion (32) has a radial extension (Re) in a radial direction (r) being transverse to the longitudinal direction, the radial extension (Re) being greater than the mouth (11b) in the rearward facing abutment surface (11a), whereby direct or indirect abutment of the manoeuvring portion (32) with the rearward facing abutment surface (11a) defines a maximum forward position of the inner drill member (30) relative to the outer tubular rigid needle (20), in which maximum forward position the inner drill member (30) extends a distance (e) out of the distal end (21) and in which maximum forward position the inner drill member (30) still extends into the rear portion (12) of the handle (10), wherein the radial extension (Re) of the manoeuvring portion (32) is greater than the mouth (12b) in the forward facing abutment surface (12a), whereby direct or indirect abutment of the manoeuvring portion (32) with the forward facing abutment surface (12a) defines a maximum rearward position of the inner drill member (30) relative to the outer tubular rigid needle (20), in which maximum rearward position the inner drill member (30) is retracted inside the outer tubular rigid needle (20) and in which maximum rearward position a rearward end (33) of the inner drill member (30) is still positioned inside the rear portion (12) of the handle (10).

2. Biopsy instrument according to claim 1 , wherein the outer tubular rigid needle (20) has a rear end (23) being positioned in flush with the rearward facing abutment surface (11a).

3. Biopsy instrument according to claim 1 , wherein the outer tubular rigid needle (20) has a rear end (23) being positioned closer to the distal end (21) than the rearward facing abutment surface (11a).

4. Biopsy instrument according to any one of claims 1-3, wherein the manoeuvring portion (32) is fixedly attached to the inner drill member (30).

5. Biopsy instrument according to any one of claims 1-4, wherein the manoeuvring portion (32) comprises a knob (32) attached to the inner drill member (30), wherein the knob (32) preferably is shaped as a wheel (32) with the longitudinal direction (L) coinciding with a rotational axis of the wheel (32).

6. Biopsy instrument according to any one of claims 1-5, wherein the biopsy instrument further comprises a distance adjusting member (40) being positioned at least partly between the manoeuvring portion (32) and the rearward facing abutment surface (11a), wherein abutment between the manoeuvring portion (32) and a rearward facing surface of the distance adjusting member (40) defines said maximum forward position of the inner drill member (30).

7. Biopsy instrument according to claim 6, wherein the distance adjusting member (40) is attached, preferably removably attached, to the inner drill member (30) between the manoeuvring portion (32) and the rearward facing abutment surface (11a), wherein the distance adjusting member (40) has a radial extension being greater than the mouth (11b) in the rearward facing abutment surface (11a).

8. Biopsy instrument according to claim 6 or 7, wherein the distance adjusting member (40) comprises a threaded portion (41) being configured to be threaded into a threaded, longitudinally extending bore (11c) in the rearward facing abutment surface (11a), and an abutment portion (42) configured to provide a rearward facing abutment surface for interaction with the manoeuvring portion (32).

9. Biopsy instrument according to any one of claims 1 -8, wherein the front portion (11) is divided into a first front portion (11’) supporting the outer tubular rigid needle (20) and a second front portion (11”) comprising the rearward facing abutment surface (11a), wherein the first and second front portions (11’, 11”) are movable relative to each other along the longitudinal direction (L) and are configured to be set at different mutual longitudinal positions thereby providing different longitudinal distances between the rearward facing abutment surface (11a) and the distal end (21) of the outer tubular rigid needle (20).

10. Biopsy instrument according to any one of claims 1-9, wherein the handle (10) is provided with one single bridging portion (13a) extending between and fixedly interconnecting the front and rear portions (11, 12) of the handle (10) and extending alongside a portion (31) of the inner drill member (30) and alongside the manoeuvring portion (32), and wherein the manoeuvring portion (32) is exposed between the front and rear portions (11, 12) of the handle (10) and alongside the bridging portion (13a) such that a user may reach the manoeuvring portion (32) with his/her fingers.

11. Biopsy instrument according to any one of claims 1-9, wherein the handle (10) comprises two bridging portions (13a, 13b) extending between and fixedly interconnecting the front and rear portions (11, 12) of the handle (10) and extending alongside each other on opposite sides of a portion (31) of the inner drill member (30) and the manoeuvring portion (32), and wherein the manoeuvring portion (32) is exposed between the front and rear portions (11, 12) of the handle (10) and between the two bridging portions (13a, 13b) such that a user may reach the manoeuvring portion (32) with his/her fingers.

12. Biopsy instrument according to any one of claims 1-11, further comprising a retraction guidance (60) to indicate when the inner drill member (30) has been fully withdrawn into the outer tubular rigid needle (20).

13. Biopsy instrument according to claim 12, wherein the retraction guidance (60) comprises visual indicator (61, 62, 63) on the handle (10) alongside the manoeuvring portion (32) or on a portion (31) of the inner drill member (30) being exposed out of the rearward facing abutment surface (11a).

14. Biopsy instrument according to any one of claims 1-13, wherein the inner drill member (30) is made of surgical steel.

15. Biopsy instrument according to claim 14, wherein a drill (35) formed at a distal end (34) of the inner drill member (30) comprises a longitudinally extending core (35a) and a helical cutting edge (35b) being formed on a helical flange (35c) surrounding said inner core (35a), wherein the inner drill member (30) preferably has a conically shaped distal end (35d).