Micro biopsy tool

Abstract

Biopsy tool (10) comprising: - a biopsy needle (12) extending along an elongation axis X and configured to be connected to a suction device, comprising: o an external sampling chamber (18), o an internal sampling chamber (22), the internal sampling chamber (22) being inside the external sampling chamber and being configured to move around or along the elongation axis X within the external sampling chamber, - insertion / retrieving means (14), - an hermetic envelope (16) configured to render the biopsy needle hermetic. The external sampling chamber presents an external collection window (30) and the internal sampling chamber presents an internal collection window (32), thus presenting a collecting configuration in which the internal collection window faces the external collection window, leading the internal sampling chamber to be put in direct communication with the zone of interest, an insertion / retrieving configuration in which the internal collection window faces the external flexible wall.

Description

MICRO BIOPSY TOOLFIELD OF INVENTION

[0001] The present invention relates to biopsy samplings, and more particularly to microbiopsy samplings.BACKGROUND OF INVENTION

[0002] Thanks to modern medicine techniques, it is possible to analyze micro-samples collected from organs or tissues from a patient and elaborate a diagnosis from those micro-samples.

[0003] The microsamples to be collected enter into the category of a Fine-Needle Aspiration biopsies (FNA) or the smallest sampling under the Core Needle Biopsy (CNB). The samples to be collected have a total dimension about 0.7-1.2 x 4-7 mm (radius x length), corresponding to a sample volume of 6.16 mm3to 31.67 mm3

[0004] There is therefore a need for a biopsy tool enabling to collect micro-samples in a safe and practical way. In this specification, micro-samples are considered to be small pieces of tissue(s) (preferably below 50pl) taken from an organ or an anatomic zone to be directly examinable under a microscope to check for disease, such as cancer.

[0005] Further, thanks to emerging micro robotic systems, microrobots navigation within the body (for example the brain) of a patient, entering the body from a single hole of a few mm is possible. This allows said microrobots to intervene inside the patient’s body in multipoint and with a 3D approach. In order to intervene inside the patient’ s body, such a microrobot must be equipped of several effectors / sensors called tools.

[0006] In particular in case of a micro-biopsy carried out by means of a microrobot, a biopsy tool able to safely collect micro-samples while being safely carried by a microrobot is necessary.

[0007] The aim of this invention is therefore to propose a biopsy tool configured to collect a micro-sample of tissues or organs from a patient’s body. This biopsy tool should also be adaptable to a microrobot.SUMMARY

[0008] This invention thus relates to a biopsy tool configured to be inserted inside a zone of interest of a patient in order to collect some element or part of an element located in said zone of interest, the biopsy tool comprising:a biopsy needle extending along an elongation axis X and configured to be connected to a suction device, comprising:o an external sampling chamber delimited by an external flexible wall, the external sampling chamber presenting an elongated shape and extending along the elongation axis X,o an internal sampling chamber delimited by an internal flexible wall, the internal sampling chamber also presenting an elongated shape and also extending along the elongation axis X, the internal sampling chamber being further located inside the external sampling chamber and being configured to move around or along the elongation axis X within the external sampling chamber,insertion / retrieving means,an hermetic envelope configured to render the biopsy needle hermetic to the zone of interest.The external flexible wall and the internal flexible wall are flexible enough to be reversibly curved with a minimal curvature radius ranging from 2 to 6mm. The external sampling chamber presents an external collection window in the external flexible wall and the internal sampling chamber presents an internal collection window in the internal flexible wall, the biopsy tool thus presenting:a collecting configuration in which the internal collection window faces the external collection window, leading the internal sampling chamber to be put in direct communication with the zone of interest,an insertion / retrieving configuration in which the internal collection window faces the external flexible wall, leading the internal sampling chamber to be isolated from the zone of interest.

[0009] This way, the solution enables to reach the here-above mentioned objective. Especially, it enables to collect micro-samples from difficult to reach spaces inside a patient, with a precise, safe and minimally invasive method.

[0010] The system according to the invention may comprises one or several of the following features, taken separately from each other or combined with each other:a length along the elongation axis X of both the external collection window and the internal collection window ranges between 3 and 20mm,- the biopsy tool is made of radio-opaque materials,- the internal sampling chamber presents an internal diameter ranging from 0,3 to 2,3mm,- the external and internal flexible walls are rendered flexible by means a series of openings forming a predefined pattern,- the internal sampling chamber is located in a distal extremity of a flexible internal catheter,- the external sampling chamber is located by a distal extremity of a flexible external catheter,- the external sampling chamber is formed inside a cap secured around the internal sampling chamber,- the external sampling chamber and the internal sampling chamber both present secondary collection windows, the biopsy tool thus being configured to further present a secondary collecting configuration in which both secondary collection windows face each other, leading the internal sampling chamber to be put in direct communication with the zone of interest,at least one of the collection window(s) of the internal sampling chamber holds a microporous wafer,- the external sampling chamber comprises a sensor configured to communicate with a tracking system located outside the zone of interest,- the external sampling chamber further comprises:o a distal extremity of an optic fiber, ando an imaging window opening inside the external flexible wall,the imagining window and the distal extremity of the optic fiber being arranged so as to enable the distal extremity of the optic fiber to illuminate the zone of interest.

[0011] The invention also relates to a biopsy kit comprising:a biopsy tool according to the here-above listed features, anda micro-robot configured to be driven from outside the zone of interest in order to carry the biopsy tool inside the zone of interest.

[0012] The biopsy tool may further comprise an internal blocking element configured to block the exit of the biopsy tool from the micro-robot inside the zone of interest.BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The invention will be better understood, and other aims, details, characteristics and advantages thereof will emerge more clearly on reading the detailed explanatory description which follows, of embodiments of the invention given by way of illustration, purely illustrative and non-limiting examples, with reference to the accompanying drawings:figures la and lb are a schematic representation of a first embodiment of a biopsy needle according to the present invention respectively in its collecting configuration and insertion / retrieving configuration,figure 2a and 2b are a schematic representation of a second embodiment of a biopsy needle according to the present invention respectively in its collecting configuration and insertion / retrieving configuration,figure 3a and 3b are a schematic representation of a third embodiment of a biopsy needle according to the present invention respectively in its collecting configuration and insertion / retrieving configuration,figures 4a, 4b and 4c are schematic representations of embodiments of a biopsy needle according to the present invention comprising at least one microporous wafer,figure 5 is a schematic representation of a further embodiment of a biopsy needle according to the present invention comprising a sensor,figure 6 is a schematic representation of a further embodiment of a biopsy needle according to the present invention comprising an optic fiber,figures 7a, 7b, 7c and 7d are schematic illustrations of different patterned flexible walls of the biopsy needle according to the present invention,figures 8a, 8b, 8c are schematic illustrations of different patterned flexible walls of the biopsy needle according to the present invention,figure 9 is a schematic illustration of a biopsy kit with a biopsy tool and a microrobot according to the present invention,figure 10 is a schematic view of a micro-robot according to the present invention; figures Ila and 11b is a schematic representation of a further embodiment of a two-parts biopsy needle according to an embodimentfigure 12 is a schematic representation of an embodiment of a biopsy needle figure 13 is a schematic representation of the section A-A and B-B of figure 12.DETAILED DESCRIPTION

[0014] As can be seen on figure 8, the biopsy tool 10 according to the present invention, is configured to be inserted inside a zone of interest 100 of a patient in order to collect some element target 101 or part of a target element 101 located inside said zone of interest 100. Said zone of interest 100 is connected to the outside of the human body through an anatomic opening O. Said anatomic opening O can be a natural opening or an artificial opening created by surgery.

[0015] The target elements 101 may be tissues or organs including the brain, pancreas, biliary system, liver, and any other organ accessible via the microrobot. The biopsied material may consist of tissues, tumors, epileptogenic zones, or any other dysfunctional tissue within these organs. It might also be considered that some non-organic elements 101 should be retrieved following a previous deposit (a sensor for example).Biopsy tool

[0016] As can be seen on figures la and lb, the biopsy tool 10 comprises:a biopsy needle 12 configured to present a collecting configuration and a insertion / retrieving configuration, the biopsy needle 12 extending along an elongation axis X and configured to be connected to a suction device S,insertion / retrieving means 14, enabling the biopsy needle 12 to be safely and precisely introduced inside the zone of interest 100 from the anatomic opening O, an hermetic envelope 16 configured to render the biopsy needle 12 hermetic to the zone of interest 100.

[0017] The biopsy needle 12 has a maximum length of 300mm and comprises:an external sampling chamber 18 delimited by an external flexible wall 20, and presenting an elongated shape and extending along the elongation axis X, an internal sampling chamber 22 delimited by an internal flexible wall 24, and presenting an elongated shape and also extending along the elongation axis X. The internal sampling chamber 22 is located inside the external sampling chamber 18 and is configured to move around or along the elongation axis X within the external sampling chamber 18.

[0018] The external sampling chamber 18 presents an internal diameter ranging from 0,5 to 2,5 mm, preferably of 1,1mm. The external sampling chamber 18 presents an external diameter ranging from 0,6 to 2,6 mm, preferably of 1,2mm. The external diameter of the sampling chamber may include the hermetic envelope 16. The internal sampling chamber 22 presents an internal diameter ranging from 0,3 to 2,3mm, preferably 0,9mm. The internal sampling chamber 22 presents an external diameter ranging from 0,4 to 2,3mm, preferably 1mm. The width of the external flexible wall 20 and of the internal flexible wall 24 ranges from 0,03 and 0,2mm, preferably 0,05mm

[0019] The external flexible wall 20 and the internal flexible wall 24 are flexible enough to be reversibly curved with a minimal curvature radius of 2 mm. Preferably, this minimal curvature radius ranges from 2 to 6mm. The curvature radius in its whole ranges from 2mm to 40mm. In differential geometry, the radius of curvature, R, is the reciprocal of the curvature. For a curve, it equals the radius of the circular arc which best approximates the curve at that point. The external flexible wall 20 and the internal flexible wall 24 can be made of stainless steel, aluminum, Nitinol, titanium, in function of the application.

[0020] The internal flexible wall 24 can also be made of an extendible mesh. The internal and external flexible walls 20, 24 can form a catheter structure (expandable mesh coated with a PEBA material, such as PEB AX®).

[0021] The external flexible wall 20 and the internal flexible wall 24 are rendered flexible by means of material retrieval or clearances in the form of a series of openings forming a predefined pattern. In a first embodiment (see figures 7a, 7b, 7c), the pattern is a homogeneous pattern regularly distributed all along the surface of the flexible walls 20, 24 (internal or external). As illustrated on figure 7a, 7b and 7c, a first pattern option presents a series of homogeneously distributed rectangularly slots, extending perpendicularly to the elongation axis X. A second pattern option is a so called “diamond structure”, the inside of the diamonds being carved out. A third pattern option is a “Kagome type” structure presenting star shaped openings. A fourth pattern option is illustrated in figure 7d, and presents a sort of “puzzle shape”. In an alternative embodiment as illustrated on figures 8a (homogeneous pattern) and 8b (evolutive pattern), the pattern is an evolutive pattern: more material is retrieved from a distal extremity of the walls 20, 24 with regards to a proximal extremity of the flexible walls 20, 24 (along the elongation axis). In this embodiment, the flexibility of the flexible walls 20, 24, and thus of the biopsy needle 12, evolves along the elongation axis X; the flexibles walls 20, 24 (and the biopsy needle 12) being more flexible at their distal extremity and less flexible at their proximal extremity. In this embodiment, the tip of the biopsy needle 12 is more flexible than the bottom of the biopsy needle 12. This also enables a better cooperation with the insertion / retrieving means 14. In a further alternative embodiment illustrated in figure 8c (to be compared with figure 8a), the pattern is an inhomogeneous pattern: more material is retrieved from specific areas of the flexible walls 20, 24 in order to increase or reduce the flexibility of specific area according to a specific design of the biopsy needle 12.

[0022] In order for the biopsy needle 12 to safely and precisely reach the target element 101 inside the zone of interest 100, the biopsy tool 10 comprises insertion / retrieving means 14. In the present embodiments, those insertion / retrieving means comprise a flexible delivery duct. Said flexible delivery duct is configured to be inserted through theanatomical opening O inside the zone of interest 100 up to the target element 101. The flexible delivery duct is further configured to enable the biopsy needle 12 to be inserted inside and pushed towards or retrieved from the target element 101 through the flexible delivery duct. The flexible delivery duct preferably presents a diameter of maximum 4mm and a length of maximum 2m, preferably 30cm. Preferably, a distal extremity configured to be connected to a micro-robot 200 (see further below). The flexible delivery conduct may be disposable.

[0023] As mentioned above, in order to enable a better cooperation between the insertion / retrieving means 14 and the biopsy needle 12, the proximal extremity of the biopsy needle 12 is less flexible than the distal extremity of the biopsy needle 12. There is also a need to ensure a strong transmission of the rotation of the internal sampling chamber 22 inside the external sampling chamber all along the elongation axis X. In the embodiments depicted in figures 12a and 12b, the biopsy needle 12 presents a proximal part 121 and a distal part 122 with different rigidities. In the depicted embodiment of figure 12, proximal part 121 has a length of 10 mm and distal part 122 has a length of 270 mm.

[0024] The proximal part 122 is preferably made of a more rigid material compared to the distal part 122. A more rigid proximal part 122 improves the rotation transmission of the internal sampling chamber 22 inside the external sampling chamber all along the elongation axis X.

[0025] In one embodiment depicted in figure Ila, the distal part 121 and the proximal part 122 are made of two different materials. The proximal part 122 preferably presents the structure of a flexible catheter with the internal flexible wall 20 being made of an expandable mesh material and the external flexible wall 24 being made of a Polyether block amide (PEBA), known under the tradename of PEBAX®. In preferable embodiments, PEBAX® 35D or 45D are used.

[0026] The proximal part 122 presents for example a homogeneous structure over all its length along the axis X. In this embodiment, the distal part 121 is made of metal (thesame metal as the expendable mesh of the internal flexible wall 20 and presents a pattern as described above in order to render it more flexible.

[0027] In an alternative embodiment, the distal part 121 and the proximal part 122 are made of the same material, preferably and expendable mesh (internal flexible wall 20) surrounded by PEBA (external flexible wall 24), the distal part 121 preferably comprising PEBAX® 55D or PEBAX® 35D, in which patterns are cut.

[0028] In the embodiment depicted in figures 1 lb and 12, the proximal part 122 presents an evolution in its rigidity along the axis X. The rigidity of the proximal part 122 diminishes progressively in direction of the distal part 121. In the particular embodiment of figure 11b, the proximal part 122 presents three zones Zi, Z2, Z3 presenting different rigidities. The external flexible wall 24 of zone Zi is made of PEBAX® 55D, external flexible wall 24 of zone Z2 is made of PEBAX® 45D, and external flexible wall 24 of zone Z3 is made of PEBAX® 35D, the flexibility thus diminishes along the axis X towards the distal part 121. The shape of the mesh of the internal flexible wall 20 can also play a role in the augmentation of or diminishing of the rigidity, in the different embodiments. In the embodiment presented on figure 12, the proximal part 122 presents five zones Zi, Z2, Z3, Z4 and Z5 presenting different rigidities. The zones Zi, Z2, Z3, Z4 and Z5 all present the same length of about 50mm, except for the more rigid zone Zi which presents a length of 7cm and the distal part 121 presents a length of 10cm. This diminishing is illustrated to happen stepwise, but in some non-depicted embodiment, it can happen continuously.

[0029] In order to ensure the isolation of the biopsy needle 12 from the zone of interest 100 (in the insertion / retrieving configuration, see further below), the hermetic envelope 16 is configured to render the flexible walls 20, 24 of the first and second sampling chambers 18, 22 which are in contact with the zone of interest 100, hermetic to the zone of interest 100. This hermetic envelope also ensures biological compatibility with the human body. It also improves sliding within the patient’s body. More precisely, the hermetic envelope 16 covers the flexible wall 20, 24, or part(s) of the flexible wall 20, 24, which is(are) in contact with the zone of interest 100. In some embodiments (see figures la, lb) the hermetic envelope 16 solely covers the external flexible wall 20, andin some embodiments (see figures 3a, 3b), the hermetic envelope 16 also covers part of the internal flexible wall 24. In this way, regardless of the its structure, the biopsy needle 12 is completely isolated from the zone of interest 100 inside the patient in its insertion / retrieving configuration (see further below).

[0030] The hermetic envelope 16 is, for example, composed of a thermos-retractable tube of PTFE material. It might also comprise a FEP heat shrink tubing (presenting similar properties than PTFE and better transparency). PEBAX® heat shrink can also be an option if flexibility and softness are critical, especially if the aim is to interface blood vessels or sensitive tissue.

[0031] Initially is typically presents a diameter 1 mm larger than the external diameter of the external diameters of the first and / or second sampling chambers 18, 22, depending on the embodiments. Once placed in the correct location, the hermetic envelope 16 can be actuated thermally to reduce its diameter and stick to the external and / or flexible wall(s) 20, 24.

[0032] As can be seen on figures la, 2b, 3a, 3b and 4a, the internal sampling chamber 22 is located in a distal extremity of a flexible internal catheter 28. More precisely, the internal sampling chamber 22 forms the distal extremity of the flexible internal catheter 28.

[0033] As can be seen on figures la, 2b and 4a, the external sampling chamber 18 is located in a distal extremity of a flexible external catheter 26. More precisely, the external sampling chamber 18 forms the distal extremity of a flexible external catheter 26. The external flexible catheter 26 is configured to be inserted inside the flexible delivery duct of the insertion / retrieving means 14.

[0034] In some alternative embodiment (see figures 3a and 3b), the external sampling chamber 18 is formed inside a cap 27 secured around the internal sampling chamber 22. The advantages of this embodiment are to reduce the number of flexible catheters (walls) from two to only one and thus improving the flexibility of the biopsy needle 12, while keeping the double wall 20, 24 mechanism required to cut the tissue, and keeping a more rigid distal extremity which improves safety. In this embodiment, the internal flexiblecatheter 28 is configured to be inserted inside the flexible delivery duct of the insertion / retrieving means 14.

[0035] The external sampling chamber 18 presents an external collection window 30 in the external flexible wall 20. The internal sampling chamber 22 presents an internal collection window 32 in the internal flexible wall 24. The external collection window 30 and the internal collection window 32 are not covered by the hermetic envelope 16. The biopsy needle 12 (and thus the biopsy tool 10) thus presents:a collecting configuration in which the internal collection window 32 faces the external collection window 32 leading the internal sampling chamber 22 to be put in direct communication with the zone of interest 100 inside the patient, an insertion / retrieving configuration in which the internal collection window 32 faces the external flexible wall 20, leading the internal sampling chamber 22 to be isolated from the zone of interest 100 inside the patient.

[0036] In its collecting configuration, the biopsy needle 12 is thus isolated from the zone of interest 100 (thanks to the hermetic envelope 16) with exception of the passage created by the alignment of the collection windows 30, 32. The length along the elongation axis X of both the external collection window 30 and the internal collection window 32 both ranges between 3 mm and 20 mm. Preferably said length is the same for both windows 30, 32. Preferably this length is of 10 mm. The external collection window 30 and the internal collection window 32 have both a top opening 35a and a bottom opening 35b (as can be seen in figure 11b), each opening 35a, 35b ranges for example from 110 to 130° around the elongation axis X. Preferably the opening is the same for both windows 30, 32, with an angle for example of 120°.

[0037] The internal collection window 32 presents at least one straight edge 33a extending along the elongation axis X.

[0038] Preferably, the internal collection window 32 presents a rectangular shape. When the biopsy needle 12 is changed from its collecting configuration to its insertion / retrieving configuration, the movement of the straight edge 33a of the internal collection window 32 with regards to the external flexible wall 24, and more particularly the cooperationbetween the moving straight edge 33 and the external flexible wall 24, leads to some tissues of the zone of interest to be pinched or cut and dragged inside the internal sample chamber 22. This sample collection is improved by usage of a suction system (see further below).

[0039] In the specific embodiment depicted in Figure 12, the internal collection window 32 comprises a beveled edge 33b that deviates from the standard straight-edge geometry. This structural modification induces an asymmetry in the window’s opening angles relative to the elongation axis X, unlike the above-described configurations where both the top opening 35a and the bottom opening 35b are typically uniform (e.g., 120° each). Such a specific embodiment enables to have an angular difference, as can be seen in figure 13. Specifically, while the opening at the base may remain at 120°, the opening at the top is widened to approximately 170°. The geometric disparity sharpens the effective tip of the inner needle, facilitating a so-called guillotine effect that ensures more precise and accurate tissue incision when the internal chamber aligns against the external wall during retrieval.

[0040] As can be seen on figures 2a and 2b, in some embodiments, the external sampling chamber 18 and the internal sampling chamber 22 both present secondary collection windows 34, 36. In those embodiments, the biopsy tool 10 is thus configured to further present a secondary collecting configuration in which both secondary windows 34, 36 face each other, leading the internal sampling chamber 22 to be put in direct communication with the zone of interest 100. In those embodiments, the internal sampling chamber 22 might be partially or totally divided in two (or more) distinct spaces, each space being put in communication with the zone of interest 100 through one different internal collection window 32, 36.

[0041] As can be seen on figures 4a, 4b and 4c, at least one of the collection window(s) 32, 36 of the internal sampling chamber 22 holds a microporous wafer 38. Such a microporous wafer 38, is a cellular capture tool, allowing to perform a molecular biopsy. Rather than cutting inside the tissue of the zone of interest 100, cells are absorbed or attracted by means of the microporous wafer 38 thereby reducing the invasiveness of the intervention. The way a microporous wafer works is well known in itself.

[0042] As already mentioned, the biopsy tool 10 is configured to be connected to a suction device S by means of the flexible internal and external catheters 26, 28. The suction device S is preferably located outside the zone of interest 100. More preferably, the suction device S is located outside the body of the patient, beyond the anatomical opening O. This suction device S enables to generate a depression inside the internal sampling chamber 22 and enables to aspire tissues or elements 101 of the zone of interest inside the internal sampling chamber 22 when the biopsy tool 10 is in its its collecting configuration. This suction leads to a safer and more precise sampling (cutting) of tissue or elements 101 from the zone of interest 100.

[0043] Typically, the suction device S is a syringe. Said syringe can be handled manually by a user or automatically driven by a control unit outside of the patient.

[0044] As already mentioned, all materials used for manufacturing the biopsy tool 10 are radiopaque, allowing real-time visualization of the biopsy needle 12 and real-time tracking of its position during any sampling / collection procedure. Additionally, as illustrated on figure 5, in some embodiments, the external sampling chamber 18 comprises a sensor 40 configured to communicate with a tracking system Z located outside the zone of interest 100. The sensor 40 is an ultrasound sensor. Preferably the sensor 40 is a piezo-electric (PZT) which transforms ultrasound into electrical signals. The sensor 40 is connected through microwires to the tracking system Z. Preferably, the tracking system Z is located outside the patient, beyond the anatomical opening O. The presence of such a sensor 40 would also accurately record the location of any sample taken from the zone of interest 100 and would ensure long-term traceability and monitoring.

[0045] In order to enable new digital biopsy techniques, some embodiments of the biopsy tool 10 according to the present invention comprises some extra technical features. More particularly, as can be seen on figure 6, in this embodiment the external sampling chamber 18 further comprises:a distal extremity of an optic fiber F, andan imaging window 42 opening inside the external flexible wall 20.In this embodiment, the imagining window 42 and the distal extremity of the optic fiber F are arranged so as to enable the distal extremity of the optic fiber F to illuminate the zone of interest 100.

[0046] Those additional technical features enable a user to perform a local biopsy using digital biopsy digital biopsy methodologies, such as the ZEISS CONVIVO® device or other specialist technology. This approach is based on the analysis of cells using imaging or spectral study of light, enabling the microstructure of tissues and the different elements 101 of the zone of interest 100 to be observed instantly and in situ.

[0047] The additional optic fiber F arranged in front of the imaging window 42 enables to precisely illuminated, film and / or identify the area of the zone of interest 100 from which a sample should be collected (by conventional or molecular biopsy). This technology offers a first instantaneous result for digital biopsy and better diagnostic accuracy for conventional or molecular biopsy.

[0048] In order to enter the zone of interest 100 inside the patient’s body through the anatomical opening O, the biopsy tool 10 can be reversibly paired to and guided by a microrobot 200 configured to be driven from outside the zone of interest 100, and preferably outside the patient’s body beyond the anatomical opening O, in order to be carried inside the zone of interest 100. In this case, the biopsy tool 10 is configured to cooperate with said micro-robot 200 in order to properly and safely reach the target element 101 inside the zone of interest 100.

[0049] In an alternative embodiment (not shown), the biopsy tool 10 can be reversibly paired with a guided catheter.

[0050] The invention is thus also about a biopsy kit comprising:a biopsy tool 10 as described here-above, and

[0051] a micro-robot 200 configured to be driven from outside the zone of interest 100 in order to open a safe and mini -invasive way for the biopsy tool 10 to follow inside the zone of interest 100. In some alternative embodiment, not represented, a further kit might comprise:a biopsy tool 10 as described here-above, anda guided catheter configured to be driven from outside the zone of interest 100 in order to open a safe and mini-invasive way for the biopsy tool 10 to follow inside the zone of interest 100.Micro-robot

[0052] As can be seen on figure 10, the micro-robot 200 is configured to navigate through the zone of interest 100 located inside the patient’s body.

[0053] As can be seen on figure 10 the microrobot 200 comprises a body 210 extending along an elongation axis A. The micro-robot 200 comprises at least one propulsion element and at least one steering element. As can be seen on figure 10, the propulsion element is located at a rear end of the micro-robot 200 and the steering element is located at a top end of the micro-robot 200. The propulsion element is independent from the steering element. In some embodiments, the micro-robot 200 further comprises an internal conduct extending through the micro-robot 200, preferably along the elongation axis A, and opens through a robot opening OR at a distal tip of the micro-robot 200.

[0054] The micro-robot 200 further comprises a tool platform 220 which can be of different shapes and can include different elements. The tool platform 220 extends along the elongation axis A and presents a distal end, a proximal end, and a side wall.

[0055] As can be seen on figure 8, a working channel 230 is arranged in the tool platform 220. The working channel 230 presents a first opening Oi and a second opening O2. The first opening Oi is located at a proximal extremity of the working channel 230 and the second opening O2 is located at a distal extremity of the working channel 230. The proximal extremity preferably coincides with the proximal end of the tool platform 220 and the first opening Oi opens in at the proximal end of the tool platform 220. The working channel 230 can be an angled channel presenting at least one angle a comprised between 30 and 90°. In case the tool platform 220 is made in a flexible material, the angle a can be a variable angle. The proximal end of the tool platform 220 is configured to be connected to the flexible conduct of the insertion / retrieving means 14. The secondopening O2 is connected to the anatomical opening O through the flexible duct of the insertion / retrieving means 14.

[0056] The biopsy needle 12 is configured to be inserted inside the working channel 230 of the tool platform 220, through the anatomical opening O, the flexible duct of the insertion retrieving means 14 and finally the first opening Oi. The biopsy needle 12 is further configured to exit the working channel 230 of the tool platform 220, inside the zone of interest 100, through the second opening O2.

[0057] In some embodiments (see figures 8 and 9), the second opening O2 is located in the side wall of the tool platform 220. In an alternative embodiment in which the microrobot 200 comprises an internal conduct, the second opening O2 of the working channel 230 puts the working channel 230 in connection with the internal conduct and with the robot opening OR.

[0058] In some embodiments, in order to improve the precision of the cooperation between the biopsy tool 10 and the micro-robot 200, a blocking element 44 (see figure 10) is added to the biopsy needle 12. This blocking element 44 is configured to guide the insertion of the biopsy needle 12 to the right length and position inside the zone of interest 100. This positioning might be guided by the tracking system Z, as well as by optional fluoroscopy. The precision which can currently be reached regarding positioning is about 1mm in 3D.

[0059] More particularly, before the intervention, the user (surgeon) measures the needed length of insertion inside the zone of interest 100 of the biopsy needle 12. After measuring, the user places the blocking element 44 at the corresponding length in the biopsy needle 12. That way, during insertion, the blocking element 44 reaches its defined position inside the working channel 230, thus avoiding the biopsy needle 12 to go deeper inside the zone of interest 100. Compared to other systems, the biopsy tool 10 according to the present invention:allows a curved trajectory of the biopsy needle 12 which improves safety margins, complex approaches, multipoint biopsies, non-aligned biopsies,allows a smaller so less invasive biopsy needle 12 to be inserted inside the zone of interest 100,allows a cooperation with highly precise imagery and thus a very precise location inside the zone of interest 100.MethodConnecting the micro-robot 200to the distal extremity of the delivery duct of the insertion / retrieving means 14,inserting the micro-robot 200 inside the zone of interest 100 through the anatomic opening O,guiding the micro-robot 200, by means of the tracking system Z, towards a target element 101 inside the zone of interest 100,inserting the biopsy needle 12, in its insertion / retrieving configuration, inside the delivery duct through the anatomic opening O,inserting the biopsy needle 12, in its insertion / retrieving configuration, inside working channel 230 of the microrobot 200 through the first opening Oi, exiting the biopsy needle 12 outside the working channel 230 through the second opening O2, OR inside the zone of interest 100,putting the biopsy needle 12 in its collecting configuration,- turning the suction device S on and generating an aspiration around the target spot inside the zone of interest 100 in order to generate a depression which sticks the element 101 (or part of said element 101) towards the internal sampling chamber 22,sampling the element of interest 101 (or part of said element 101) by putting the biopsy needle 12 back into its insertion / retrieving configuration,retrieving the sample through the flexible internal catheter 28towards the anatomic opening O,retrieving the biopsy needle 12 inside the working channel 230 of the micro-robot 200,retrieving the biopsy needle 12 inside the flexible duct of the insertion / retrieving means 14,retrieving the micro-robot 200 towards the anatomic opening O.

Claims

CLAIMS1. Biopsy tool (10) configured to be inserted inside a zone of interest (100) of a patient in order to collect some element (101) or part of an element (101) located in said zone of interest (100), the biopsy tool (10) comprising:a biopsy needle (12) extending along an elongation axis X and configured to be connected to a suction device (S), comprising:o an external sampling chamber (18) delimited by an external flexible wall (20), the external sampling chamber (18) presenting an elongated shape and extending along the elongation axis X,o an internal sampling chamber (22) delimited by an internal flexible wall (24), the internal sampling chamber (22) also presenting an elongated shape and also extending along the elongation axis X, the internal sampling chamber (22) being further located inside the external sampling chamber (18) and being configured to move around or along the elongation axis X within the external sampling chamber (18), insertion / retrieving means (14),an hermetic envelope (16) configured to render the biopsy needle (12) hermetic to the zone of interest (100),wherein the external flexible wall (20) and the internal flexible wall (24) are flexible enough to be reversibly curved with a minimal curvature radius ranging from 2 to 6mm, wherein the external sampling chamber (18) presents an external collection window (30) in the external flexible wall (20) and the internal sampling chamber (22) presents an internal collection window (32) in the internal flexible wall (24), the biopsy tool (12) thus presenting:a collecting configuration in which the internal collection window (32) faces the external collection window (30), leading the internal sampling chamber (22) to be put in direct communication with the zone of interest (100),an insertion / retrieving configuration in which the internal collection window (32) faces the external flexible wall (20), leading the internal sampling chamber (22) to be isolated from the zone of interest (100).

2. Biopsy tool (12) according to the preceding claim, wherein a length along the elongation axis X of both the external collection window (30) and the internal collection window (32) ranges between 3 and 20 mm.

3. Biopsy tool (12) according to any one of the preceding claims, wherein the biopsy tool (12) is made of radio-opaque materials.

4. Biopsy tool (12) according to any one of the preceding claims, wherein the internal sampling chamber (22) presents an internal diameter ranging from 0,3 to 2,3mm.

5. Biopsy tool (12) according to any one of the preceding claims, wherein the external and internal flexible walls (20, 24) are rendered flexible by means a series of openings forming a predefined pattern.

6. Biopsy tool (10) according to any one of the preceding claims, wherein the internal sampling chamber (22) is located in a distal extremity of a flexible internal catheter (28).

7. Biopsy tool (10) according to any one of the preceding claims, wherein the external sampling chamber (18) is located by a distal extremity of a flexible external catheter (26).

8. Biopsy tool (10) according to any one of claims 1 to 6, wherein the external sampling chamber (18) is formed inside a cap (27) secured around the internal sampling chamber (22).

9. Biopsy tool (10) according to any one of the preceding claims, wherein the external sampling chamber (18) and the internal sampling chamber (22) both present secondary collection windows (34, 36), the biopsy tool (10) thus being configured to further present a secondary collecting configuration in which both secondary collection windows (34, 36) face each other, leading the internal sampling chamber (22) to be put in direct communication with the zone of interest (100).

10. Biopsy tool (10) according to any one of the preceding claims, wherein at least one of the collection window(s) (32, 36) of the internal sampling chamber (22) holds a microporous wafer (38).

11. Biopsy tool (10) according to any one of the preceding claims, wherein the external sampling chamber (18) comprises a sensor (40) configured to communicate with a tracking system (Z) located outside the zone of interest (100).

12. Biopsy tool (10) according to any one of the preceding claims, wherein the external sampling chamber (18) further comprises:a distal extremity of an optic fiber (F), andan imaging window (42) opening inside the external flexible wall (20), the imagining window (42) and the distal extremity of the optic fiber (F) being arranged so as to enable the distal extremity of the optic fiber (F) to illuminate the zone of interest (100).

13. Biopsy kit comprising:a biopsy tool (10) according to any one of the preceding claims, anda micro-robot (200) configured to be driven from outside the zone of interest (100) in order to carry the biopsy tool (10) inside the zone of interest (100).

14. Biopsy kit according to the preceding claim, wherein the biopsy tool further comprises an internal blocking element (44) configured to block the exit of the biopsy tool (10) from the micro-robot (200) inside the zone of interest (100).

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