Bioimpedance probe

Abstract

A probe (100) for obtaining a biopsy. The probe comprises a biopsy needle (110) and a pair of electrodes (112) disposed on the biopsy needle. The probe also comprises an electronics module (118). The electronics module is configured, in use, to apply a voltage across the pair of electrodes to obtain bioimpedance data.

Description

[0001] Bioimpedance probe

[0002] The present invention relates to a probe for obtaining a biopsy. More particularly, but not exclusively, the invention relates to a probe for measuring the bioimpedance of tissue prior to obtaining a biopsy.

[0003] Background

[0004] A biopsy is a procedure in which a tissue sample is taken from a patient. For example, a healthcare professional may take a tissue sample (the sample itself is also referred to as a “biopsy”) and send the sample to a laboratory for subsequent analysis. This enables healthcare professionals to determine whether the tissue is healthy, or whether it is unhealthy (e.g., it may be cancerous).

[0005] One method for determining whether the tissue is cancerous is to measure its impedance when AC voltages with various frequencies are applied across it. The impedance of tissue is referred to as bioimpedance. The bioimpedance of healthy tissue differs from unhealthy tissue, and so it possible to identify whether the tissue is healthy or not by obtaining bioimpedance measurements.

[0006] A disadvantage of taking a biopsy and subsequently analysing the tissue is that there is a wait time for the patient. After the tissue sample is obtained, there is often a time delay associated with the transfer to and from the laboratory, in addition to the time taken for sample to be analysed.

[0007] Even if a tissue sample is analysed and determined to be healthy, it does not always mean the patient is healthy. For example, the tissue sample may have been taken from a healthy region of tissue, and an unhealthy region of tissue within the patient may have been missed. To combat this problem, healthcare professionals are often required to take several biopsies.

[0008] Another disadvantage of taking a biopsy is that it can be painful for a patient, and it can cause bleeding. This problem is exacerbated by the fact that healthcare professionals are required to take several biopsies. The present invention was devised with the foregoing in mind.

[0009] Summary of Invention

[0010] According to a first aspect of the invention, there is provided a probe for obtaining a biopsy.

[0011] The probe comprises a biopsy needle. The probe comprises a pair of electrodes disposed on the biopsy needle. The probe comprises an electronics module. The electronics module is configured, in use, to apply a voltage across the pair of electrodes to obtain bioimpedance data.

[0012] Having electrodes on a biopsy needle enables the bioimpedance of tissue of a patient to be analysed in real time without having to remove the tissue. This enables a user of the probe to determine whether or not the tissue is likely to be unhealthy (e.g., cancerous) before deciding whether to obtain a biopsy.

[0013] Applying a voltage across a pair of electrodes may comprises applying an AC voltage to a first electrode of the pair of electrodes. The electronics module may be configured to measure the voltage at a second electrode of the pair of electrodes.

[0014] Bioimpedance data may refer to the measured bioimpedance of tissue. Bioimpedance data may refer to data from which the bioimpedance of tissue can be calculated. Bioimpedance data may refer to the voltage applied to a first electrode of the pair of electrodes, the measured voltage at a second electrode of the pair of electrodes, and the frequency of the applied voltage.

[0015] The electronics module may comprise a processor. The processor may be configured to process the bioimpedance data. The processor may be configured to calculate the impedance of the tissue based on the bioimpedance data.

[0016] The electronics module may comprise a transmitter. The transmitter may be configured to transmit the bioimpedance data to an external device. The transmitter may be configured to transmit the bioimpedance data to a cloud server. Transmitting the bioimpedance data to an external device reduces the required level of processing that occurs within the probe. This reduced the size, weight, and complexity of manufacture for the probe.

[0017] The electronics module may be separable from the rest of the probe.

[0018] Having a separable electronics module enables the same electronics module to be reused with many different probes. This improves the longevity of the probe. Having a separable electronics module may enable the same electronics module to be reused and the rest of the probe may be configured to be disposable and may be designed for single use. The separable electronics module may be used with a reusable probe, in which case the probe should always be sterilised for individual patients.

[0019] The biopsy needle may comprise a core and an insulating layer surrounding the core. The electrodes may be disposed between the core and the insulating layer.

[0020] Having an insulating layer may protect the electrodes from damage and prevent signal interference.

[0021] The electrodes may extend from a tip of the needle to a base of the needle. The electrodes may be exposed at the tip of the needle and the base of the needle.

[0022] The electronics module may be connectable to the electrodes via a connector, said connector comprising bond pads in electrical contact with the portion of the electrodes exposed at the base of the needle.

[0023] Connecting the electrodes to the electronics module at the base of the needle reduces the overall size of the probe and prevents electrical connections from interfering with the insertion of the needle into a patient.

[0024] The biopsy needle may be surrounded by a retractable sheath. Actuating the biopsy needle may refer to retracting the sheath. Actuating the biopsy needle may refer to transitioning the sheath between an extended and retracted position. The probe may comprise a first spring system configured, in use, to retract the sheath. The probe may comprise a second spring system configured, in use, to return the sheath to its original position.

[0025] The probe may comprise a spring compression trigger. The spring compression trigger which enables a user to compress the first and second spring systems. The spring compression trigger which enables a user to compress the first and second spring systems simultaneously. The first and second spring systems may be locked in a compressed state respectively via a first and second latch.

[0026] The probe may comprise a first user-operable actuation trigger configured to actuate the biopsy needle.

[0027] The probe may comprise a second user-operable actuation trigger configured to actuate the biopsy needle.

[0028] Having two user-operable actuation triggers enables a user to grip the probe in different way whilst still being able to operate the probe. This allows a user to use the probe in a wider variety of conditions.

[0029] Pressing either of the user-operable actuation triggers for a first time may release the first latch to release the first spring system from its compressed state. Releasing the first spring system from its compressed state may cause the sheath to retract.

[0030] Pressing either of the user-operable actuation triggers for a second time may release the second latch to release the second spring system from its compressed state. Releasing the second spring system from its compressed state may cause the sheath to return to its original extended position.

[0031] The probe may comprise a first user-operable measurement trigger configured to activate the electronics module to apply a voltage across the pair of electrodes to obtain bioimpedance data. The probe may comprise a second user-operable measurement trigger configured to activate the electronics module to apply a voltage across the pair of electrodes to obtain bioimpedance data.

[0032] Having two user-operable measurement triggers enables a user to grip the probe in different way whilst still being able to operate the probe. This allows a user to use the probe in a wider variety of conditions.

[0033] According to a second aspect of the invention, there is provided a system for obtaining a biopsy.

[0034] The system comprises a probe and a console. The probe may be the probe according to the first aspect of the invention.

[0035] The probe comprises a biopsy needle comprising a pair of electrodes. The probe comprises an electronics module comprising a transmitter. The electronics module is configured, in use, to apply a voltage across the pair of electrodes to obtain bioimpedance data.

[0036] The console comprises a receiver configured to receive bioimpedance data transmitted by the transmitter of the probe. The receiver may be a wireless receiver in wireless communication with the transmitter of the probe. The receiver may be a wired receiver in wired communication with the transmitter of the probe.

[0037] The console comprises a console processor configured to analyse the bioimpedance data. The console comprises a feedback mechanism configured to communicate with a user.

[0038] The processor may be configured to analyse the bioimpedance data to provide a classification of the tissue for which the bioimpedance data was obtained. The classification may whether the tissue is cancerous or not. The feedback mechanism may be configured to communicate the classification to the user.

[0039] The console processor may perform the classification using an Elman neural network. The console processor may perform the classification by inputting the bioimpedance data into trained machine learning models for evaluating the input patient's data to determine the most similar type of tissues.

[0040] The console processor may perform the classification by inputting bioimpedance data into a biological statistical methodology model built from a healthy / benign / cancer database.

[0041] The console processor may perform the classification using one or more of: bio- statistical metrology, deep-learning, machine learning, or neural network methods.

[0042] The feedback mechanism may be a visual display. The feedback mechanism may be a visual display mounted within a users' horizontal visual field. This may improve the user's ergonomics when performing the biopsy.

[0043] Optional features of any of the above aspects may be combined with the features of any other aspect, in any combination. For example, features described in connection with the probe of the first aspect may have corresponding features definable with respect to the system of the second aspect, and vice versa, and these embodiments are specifically envisaged. Features which are described in the context or separate aspects and embodiments of the invention may be used together and / or be interchangeable wherever possible. Similarly, where features are, for brevity, described in the context of a single embodiment, those features may also be provided separately or in any suitable subcombination.

[0044] Brief description of the drawings

[0045] Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0046] Figure 1 shows a schematic view of a probe according the present invention;

[0047] Figures 2a and 2b respectively show a perspective view of a probe according to the present invention and the probe being held by a user; Figures 3a and 3b show enlarged perspective views of the biopsy needle of the probe of Figures 2a and 2b with the sheath in forward and retracted positions respectively;

[0048] Figures 4a and 4b show cross-sectional views of the biopsy needle of the probe of Figures 2a and 2b;

[0049] Figure 5 shows a cross-sectional view of another biopsy needle;

[0050] Figures 6a and 6b respectively show perspective views of the tip and base of a biopsy needle;

[0051] Figures 7a and 7b show perspective views of the probe of Figures 2a and 2b with the electronics module removed;

[0052] Figures 8a-8c show enlarged views of the connector of the probe of Figures 2a and 2b;

[0053] Figures 9a and 9b show perspective views of an alternative probe according to the present invention with the electronics module connected, and removed, respectively;

[0054] Figure 10 shows a perspective view of another alternative probe according to the present invention with the electronics module removed;

[0055] Figure 11 shows a schematic view of a system according to the present invention;

[0056] Figures Ila and 11b show a system according to an embodiment of the present invention;

[0057] Figures 12(a)-(c), 13(a)-(b) and 14(a)-(b) show steps of a method for using a system according to the present invention;

[0058] Figure 15 shows a perspective view of a probe with a removable electronics housing;

[0059] Figure 16 shows a perspective view of an alternative probe; and

[0060] Figure 17 shows a perspective view of a casing. Detailed

[0061] Figure 1 shows a schematic view of a probe 100.

[0062] The probe 100 comprises a biopsy needle 110. The probe 100 comprises a pair of electrodes 112 positioned on the biopsy needle 110. The probe 100 comprises an electronics module 118 configured, in use, to apply a voltage across the pair of electrodes 112.

[0063] The electronics module 118 is configured to apply an AC voltage to a first of the pair of electrodes 112 and to measure the voltage at the second of the pair of electrodes 112. The electronics module 118 is configured to apply an AC voltage with a frequency that changes with time.

[0064] In some embodiments, the electronics module 118 is configured to provide a lOOmV AC voltage. In some embodiments, the electronics module comprises a lithium battery.

[0065] The probe 100 comprises a user-operable actuation trigger 114. The user-operable actuation trigger is a trigger which, when operated by a user, actuates the biopsy needle 110 to obtain a biopsy from a patient.

[0066] In some embodiments, the actuation trigger 114 is a push button. In some embodiments, the actuation trigger 114 is a sliding mechanism.

[0067] The probe 100 comprises a user-operable measurement trigger 116. The user-operable measurement trigger 116 is a trigger which, when operated by a user, causes the electronics module 118 to apply an AC voltage across the pair of electrodes 112 to obtain bioimpedance data.

[0068] In some embodiments, the measurement trigger 116 is a push button. In some embodiments, the measurement trigger 116 is a sliding mechanism. The electronics module 118 comprises a processor 105 configured to process the bioimpedance data. The electronics module 118 comprises a transmitter 120 configured to transmit the processed bioimpedance data to an external device.

[0069] In some embodiments, the processor 105 processes the bioimpedance data by creating a data file (e.g., a “csv” file) recording / storing the voltage applied to the first of the pair of the electrodes 112 for a given AC voltage frequency and the voltage measured at the second of the pair of the electrodes 112 for the same frequency. The data file may contain the applied and measured voltages across a spectrum of frequencies. In some embodiments, the processor 105 also records the relative phase shift between the applied and recorded voltages.

[0070] Figure 2(a) shows a perspective view of a probe 200. The probe 200 comprises a biopsy needle 210 with a pair of electrodes disposed thereon. The probe 200 comprises a body 201.

[0071] The probe 200 comprises a first user-operable actuation trigger 214-1 and a second a user-operable actuation trigger 214-2. The probe comprises a first user-operable measurement trigger 216-1 and a second user-operable measurement trigger 216-2. Having multiple user-operable triggers 214-1,2, 216-1,2 enables a user to hold and grip the probe 200 in different ways, as shown in Figure 2(b).

[0072] The first user-operable actuation trigger 214-1 comprises a plurality of ridges. The ridges provide a surface against which a user can exert a force so as to actuate the biopsy needle 210. The second user-operable actuation trigger 214-2 is a flat surface against which a user can exert a force so as to actuate the biopsy needle 210. Actuation of the biopsy needle refers to the retraction and extension of a sheath surrounding the biopsy needle 210, as will be explained below.

[0073] The first and second user-operable measurement triggers 216-1, 2 are push buttons. Pressing either, or both, of the user-operable measurement triggers 216-1, 2 causes a voltage to be applied across the pair of electrodes disposed on the biopsy needle 210 in order to obtain bioimpedance measurements. The probe 200 comprises a spring loading trigger 219. The spring loading trigger 219 is pressed by a user to compress springs housed within the probe body 201. In some embodiments of the invention, pressing the spring loading trigger 219 compresses two springs, or two sets of springs, within the probe body 201. Compressing springs stores energy which can be released, in response to a user operating one of the actuation triggers 214-1 , 2, to retract and / or extend the sheath surrounding the biopsy needle 210, as will be described below.

[0074] In the embodiment shown, the spring loading trigger 219 is a sliding mechanism. In other embodiments, the spring loading trigger 219 is a simple push button, a rotary switch, or any other suitable means for enabling the compression of springs within the probe body 201.

[0075] In an embodiment, the user slides the spring loading trigger 219 down until a spring latch locks the two springs, or spring systems, in a compressed state. Pressing either of the user-operable actuation triggers for a first time releases a first of the latches to release the energy stored in a first spring or spring system. Pressing either of the user- operable actuation triggers for a second time releases a second of the latches to releases the energy stored in a second spring or spring system.

[0076] Figures 3(a) and 3(b) show the biopsy needle 210 in greater detail.

[0077] Figure 3(a) shows a perspective view of the biopsy needle 210 inside a sheath 215. The sheath 215 is retractable relative to the biopsy needle 210.

[0078] The sheath 215 is connected to two or more springs, or two or more sets of springs, housed within the probe body 201. A user compresses the springs by pressing the spring loading trigger 219. After pressing the spring loading trigger 219, a user can press either of the actuation triggers 214-1 , 2 to release a first spring, or first set of springs, to cause the sheath 215 to rapidly retract. Figure 3(b) shows biopsy needle 210 with the sheath 215 retracted. A user can then press either of actuation triggers 214-1 , 2 for a second time to release a second spring, or second set of springs, to cause the sheath 215 to rapidly extend, meaning it returns to its original position (as shown in Figure 3(a)). The biopsy needle 210 comprises a notch 217. The notch 217 is only visible when the sheath 215 is retracted. In use, the notch 217 of the biopsy needle 210 is configured to cut and remove a biopsy (tissue sample) from a patient. The notch 217 is on the opposite side of the biopsy needle 210 to the electrodes 212.

[0079] Figures 4(a) and 4(b) show cross-sectional views of the biopsy needle 210. The biopsy needle 210 comprises a core 213 coated with an insulation layer 211. The electrodes 212 are disposed on the core 213 and are partially covered by the insulation layer 211.

[0080] The electrodes 212 extend from a tip of the needle 210 to a base of the needle 210. The insulation layer 211 extends between the tip of the needle 210 and the base of the needle 210 but does not cover the tip of the needle 210 or the base of the needle 210, such that the electrodes 212 are exposed at the base and the tip of the needle 210.

[0081] In some embodiments, the core 213 is, or comprises, steel. In some embodiments, the insulation layer 211 is, or comprises, PTFE.

[0082] In some embodiments, the core 213 is, or comprises, surface insulative modified steel or high strength polymer. In some embodiments, the insulative modified steel is coated by polymer, silicon dioxide, or metal oxides. In some embodiments, the insulation layer is, or comprises, polymer coating, silicon dioxide coating, or a metal oxide coating.

[0083] In use, a user inserts the biopsy needle 210 into a patient. As the tip of the biopsy needle 210 penetrates the skin of a patient, the electrodes 212 contact a region of tissue within the patient.

[0084] Figure 4b shows an electrical circuit formed between the electrodes 212 when the microneedle 210 inserted into a patient and contacts tissue 217.

[0085] The stray capacitance between the electrodes 212 is represented with a capacitor Cs. The capacitance between each of the electrodes 212 and the tissue 217 is represented using capacitors Ci and C2 respectively. The impedance of the tissue 217 is represented using resistor R. In use, a voltage is applied across the electrodes 212 and the bioimpedance (represented by resistor R) is measured. As described earlier in the description, to measure the impedance of the tissue 217, an AC voltage is applied to one electrode 212, and the voltage at the other electrode 212 is measured. The difference between the voltages at each electrode 212 is used to determine the impedance of the tissue 217 between the electrodes 212. Multiple AC voltages, each having a different frequency, or a constant AC voltage with increasing / decreasing frequency, is applied across the electrodes 212.

[0086] Figure 5 shows a cross-sectional view of another biopsy needle 10 in accordance with the present invention.

[0087] The biopsy needle 10 comprises a core 13 made from, or comprising, stainless steel. The core is coated with a first insulation layer 11 made from, or comprising, PTFE.

[0088] In some embodiments, the biopsy needle comprises a core made from, or comprising, surface insulative modified stainless steel or high-strength polymer. In some embodiments, the core is coated with a first insulation layer made from, or comprising, a polymer coating, silicon dioxide coating, or metal oxide coating.

[0089] A layer of titanium 14 is applied over the first insulation layer 11. Electrodes 12, which are formed from, or comprise, platinum, are applied onto the titanium. A layer of gold 15 is applied over the electrodes 12 to provide a bond pad, which is a surface to / from which electrical connections can be made. Finally, a second insulation layer 16 made from, or comprising, SiO2, covers and protects the layers 12, 14, 15 on top of the first insulation layer 11. The specific materials recited in relation to Figure 5 are provided by way of example only, and the skilled person will recognise that other suitable materials can be used.

[0090] Whilst Figure 5 shows all layers being present simultaneously, only certain layers may be present for a given cross section along the length of the needle 10.

[0091] Although the electrodes 312 are shown as simple straight lines of conductive material, in other embodiments the shape of the electrodes 312 can differ. In some embodiments, the portions of the electrodes 312 exposed at the tip of the needle can be T-shaped or have any other shapes. Figure 6(a) shows a perspective view of the tip of a biopsy needle, together with a crosssection view taken along the longitudinal axis of the needle. Figure 6(b) shows a perspective view of the base of a biopsy needle, together with a cross-section view taken along the longitudinal axis of the needle.

[0092] In Figures 6(a) and 6(b), the needle comprises a core 313 surrounded by a first insulation layer 311. The electrodes 312 are formed as a layer of conductive material disposed over the first insulation layer 311. The electrodes 312 extend along the entire length of the needle from the base to the tip.

[0093] A second insulation layer 316 surrounds the electrodes 312. However, as shown in Figures 6(a) and (b), the second insulation layer 316 does not extend to the tip and base of the needle, meaning the electrodes 312 are exposed at the base and the tip of the needle.

[0094] Figures 7(a) and (b) show perspective views of the probe 200 with the electronics module 218 detached from the body 201.

[0095] The probe 200 comprises a connector 221 which enables the electrical connection between the electronics module 218 and the electrodes 212 on the biopsy needle 210. The connector 221 comprises a socket 222 which is configured to receive a plug 224 of the electronics module 218. The plug 224 fits inside the socket 222 when the electronics module 218 is connected to the probe 200 and provides an electrical connection therebetween.

[0096] In the embodiment of Figures 7(a) and 7(b), the electronics module 218 is completely detachable from the body 201 of the probe 200. The body 201 comprises a projection 202. The electronics module 218 comprises a corresponding recess (not shown) which enables a sliding fit connection between the electronics module 218 and the projection 202.

[0097] The connector 221 is shown in greater detail in Figures 8(a)-(c). In other embodiments, alternative connectors 221 can be used to connect the electronics module 218 and the electrodes 212. Figure 8(a) shows a perspective view of the connector 221 with the biopsy needle 210 connected to it. Figure 8(b) is an enlarged view of the connector 221 from a different perspective view.

[0098] Connector 221 comprises a first hub 223 and a second hub 225. The first and second hubs 223, 225 connect to each other so as to fix and retain a base of the biopsy needle 210 between them.

[0099] The connector 221 comprises a flexible PCB 227 which is connected, at a first end, to the first needle hub 223. The socket 222 is disposed on the flexible PCB 227 proximate a second end of the PCB 227.

[0100] Two bond pads 228 are disposed on the first end of the flexible PCB 227. The bond pads 228 enable electrical connection between the PCB 227 and the electrodes 212. Two gold wires 232 are used to electrically connect the electrodes 212 to the bond pads 228. The gold wires 232 are connected to the bond pads 228 and to the electrodes 212 at the base of the biopsy needle 210. In other embodiments, the gold wires 232 are replaced with alternative electrically conductive wires.

[0101] The connector 221 comprises a shield 226 to protect the gold wires 232. As shown in Figure 8(c), the shield 226 is connected to the hubs 223, 225 using a Polydimethylsiloxane (PDMS) seal 230. The seal 230 and shield 226 protect the gold wires 232 and bond pads 228 from damage. In other embodiments, the seal 230 is formed from, or comprises, alternative materials.

[0102] Figure 16 shows an alternative probe 600. The probe 600 is similar to the other probes described herein, but the electrodes 612 are arranged differently at the base of the needle. Rather than being side by side, as in Figure 8(b), the electrodes 612 are offset or aligned substantially longitudinally with the needle. The electrodes 612 are connected to bond pads 628. The electrodes 612 and bond pads 628 may be made from or comprise gold or titanium, or any adhesive conductive material. In the embodiment shown, the electrodes 612 are connected to bond pads 628 via gold wires 632, similarly to in Figure 8(b). Alternatively, the wires 632 may be made from aluminium or any conductive material. The bonding between electrodes 612 and gold wire 632 can be achieved using an ultrasound enhanced bonding technique, or a conductive adhesive bonding technique. The bonding between the bond pads 628 and gold wire 632 can be achieved using an ultrasound enhanced bonding technique, or a conductive adhesive bonding technique. The electrodes 612 can travel around the axis of the needle as they progress towards the needle tip such that they are still side by side and parallel at the needle tip.

[0103] Figures 9(a) and 9(b) shows an alternative probe 300. The probe 300 is substantially similar to probe 200, but the electronics module 318 is connectable to the rest of the probe 300 in a different manner.

[0104] Whereas probe 200 uses a projection 202 to enable a sliding fit (as described in relation to Figures 7(a) and (b)), probe 300 comprises an electronics housing 340 with an end cap 341. When the electronics module 318 is connected to the probe body 301 , it is positioned within the electronics housing 340 and retained therein using the end cap 341. The electronics housing 340 comprises a plurality of ridges which provide an improved grip for a user.

[0105] Figure 9(a) shows the probe 300 with the electronics module 318 within the electronics housing 340. Figure 9(b) shows the probe 300 with the electronics module 318 outside the electronics housing 340 and with the end cap 341 removed.

[0106] The electronics module 318 connects to the electrodes of the needle 310 using a connector identical to that shown in Figures 8(a)-(c). In other embodiments, alternative connectors can be used.

[0107] Figure 15 shows an alternative probe 500. The probe 500 comprises an electronics module 518. The probe 500 comprises an electronics housing 540 similar to the electronics housing 340 of the probe 300 of Figure 9.

[0108] The electronics housing 540 is removable from the probe 500. The electronics housing 540 is removable such that a user can remove the electronics module 518 from the probe 500. Removing the electronics housing 540 enables a user to remove the electronics module 518 by simply pulling it away from the probe 500, rather than requiring a user to slide the electronics module 518 along the longitudinal axis of the needle. The electronics housing 540 of the probe 500 enables a user to remove the electronics module 518 without having to bring their hands / fingers into close proximity with the needle tip.

[0109] Figure 10 shows another alternative probe 400. Probe 400 comprises an electronics module 418 which connects to a body 401 of the probe 400 at an opposing side of the body 401 to the needle 410.

[0110] The probe 400 comprises an actuation trigger 414 which is part of the body 401. The probe 400 comprises a measurement trigger 416 which is part of the electronics module 418.

[0111] Figure 11 show a schematic view of a system 1000 for obtaining a biopsy. The system 1000 comprises a probe 1100 and a console 1300.

[0112] The probe 1100 comprises a biopsy needle comprising a pair of electrodes, and an electronics module 1118 comprising a transmitter 1120. The electronics module is configured, in use, to apply a voltage across the pair of electrodes to obtain bioimpedance data. In some embodiments, the probe 1100 is one of the probes described earlier in the description and / or presented in an earlier figure.

[0113] The console 1300 comprises a receiver 1320 configured to receive bioimpedance data transmitted by the transmitter 1120 of the probe 1100. The bioimpedance data can be transmitted between the transmitter 1120 and the receiver 1320 using any suitable wireless communications system, such as Bluetooth or Wi-Fi.

[0114] The console 1300 comprises a console processor 1330 configured to analyse the bioimpedance data received by the receiver 1320 to provide a classification. The console 1300 comprises a feedback mechanism 1310 configured to communicate the classification to a user.

[0115] In some embodiments, the transmitter 1120 transmits bioimpedance data measured for the tissue of a patient for a range of AC voltage frequencies to the receiver 1320 of the console 1300. In some embodiments, the receiver 1320 receives the raw data measured by the probe 1100. For example, the receiver 1320 can receive data (e.g., as a “csv” file) showing the voltage applied to a first electrode of the pair of electrodes and the voltage measured at a second electrode of the pair of the electrodes. In such an example, the console processor 1330 may calculate the bioimpedance based on the raw data and then perform classification based on the bioimpedance. Alternatively, the console processor 1330 can perform the classification based directly on the raw data.

[0116] In other embodiments, the receiver 1320 receives bioimpedance data which has been pre-processed by the electronics module 1118. In such embodiments, the receiver 1320 may receive the measured bioimpedance for a range of AC voltage frequencies, rather than receive the actual voltage measurements.

[0117] The processor 1330 can use any of a variety of classification methods. In some embodiments, the console processor 1330 uses a neural network (such as an Elman neural network) to classify the tissue based on the bioimpedance data. In some embodiments, the console processor 1330 uses alternative machine learning, or any other Al, algorithms to classify the tissue based on the bioimpedance data. In some embodiments, the console processor 1330 classifies the tissue using the bioimpedance data and a set of predetermined threshold values. In some embodiments, the console processor 1330 classifies the tissue using the bioimpedance data and a set of statistical models.

[0118] The console processor 1330 can be configured to provide binary classification. For example, the console processor 1330 can be configured to classify tissue of a patient as healthy or not healthy. The console processor 1330 can be configured to classify the tissue of a patient as cancerous or non-cancerous.

[0119] The console processor 1330 can be configured to provide classification into three or more categories. For example, the console processor 1330 can be configured to classify tissue of a patient as healthy, benign, or cancerous.

[0120] The feedback mechanism 1310 can be configured to provide one or more of: visual feedback, auditory feedback, and tactile feedback. For example, the feedback mechanism 1310 can be any of: a display, a buzzer, a speaker, an actuator, a vibration device, an LED, etc.

[0121] The feedback mechanism 1310 may be a visual display. In the embodiment shown in Figures I la and 11b, the feedback mechanism is remotely mounted beside an ultrasound instrument 1305 or stands alone but within a user's horizontal visual field. This arrangement can provide improved ergonomics for the user when taking a biopsy.

[0122] In one embodiment, e.g. as shown in Figures I la and 11b, the feedback mechanism 1310 is or comprises a traffic light system. In such an embodiment, the feedback mechanism 1310 comprises a green light, an amber light, and a red light. The feedback mechanism 1310 is configured to display a green light when the processor 1330 classifies the tissue as healthy. The feedback mechanism 1310 is configured to display an amber light when the processor 1330 classifies the tissue as benign. The feedback mechanism 1310 is configured to display a red light when the processor 1330 classifies the tissue as cancerous.

[0123] Figures 12(a)-(c), 13(a)-(b) and 14(a)-(b) show the steps of a method for taking a biopsy using the system of the present invention.

[0124] To start, a user presses the spring loading trigger to compress two or more springs, or sets of springs, within the probe body, as shown in Figure 12(a).

[0125] As shown in Figure 12(b), the second step is to calibrate the probe 1100. This is done by inserting the tip of the biopsy needle into a calibrator gel 1400 which has known impedance. Once the tip is inserted into the gel 1400, a user operates one of the measurement triggers. The measured impedance is compared with the known impedance to confirm that the probe 1100 is functioning correctly.

[0126] Once the probe 1100 is calibrated, the biopsy procedure starts, as shown in Figure 12(c). The needle is inserted into the tissue 217 of the patient and the user operates one of the measurement triggers. In response to the user operating one of the measurement triggers, the electronics module applies an AC voltage across the electrodes in order to measure the impedance of the tissue 217. The electronics module applies an AC voltage (with changing frequency) to a first electrode of the pair of electrodes and records the voltage measured at a second electrode of the pair of electrodes. The applied voltage, measured voltage, and AC frequency are recorded together to form the bioimpedance data. From this bioimpedance data, the bioimpedance for each frequency can be determined (as discussed above, the impedance can be calculated in the probe 1100 or in the console 1300, and both alternatives fall within the scope of this invention).

[0127] The measured bioimpedance data is transmitted to the console 1300 for real-time diagnostics. In Figure 12(c), the needle tip is in a healthy region 217-1 of the tissue 217, and so when the console processor 1330 analyses the bioimpedance data to perform a classification, it provides a “healthy” classification. This classification is communicated to the user via the feedback mechanism which, in the embodiment shown, is a display. Because the feedback mechanism communicates to the user that the tissue in contact with the needle tip is healthy, the user does not need to obtain a biopsy.

[0128] In Figure 13(a), the needle is inserted further into the tissue 217 of the patient and the previous step of taking a measurement is repeated. As with Figure 12(c), the needle tip is in a healthy region 217-1 of the tissue 217, and so the console processor 1130 provides another “healthy” classification when the user operates one of the measurement triggers.

[0129] In Figure 13(b), the needle is inserted even further into the tissue 217 of the patient and has reached a tumour 217-2. The user repeats the previous step by operating one of the measurement triggers to obtain a bioimpedance measurement which is sent to the console 1300.

[0130] When the console processor 1330 analyses the bioimpedance data, it will provide an unhealthy classification. The unhealthy classification is communicated to the user through the feedback mechanism. Because the feedback mechanism communicates to the user that the tissue in contact with the needle tip is unhealthy tissue, the user needs to obtain a biopsy.

[0131] Figure 14(a) shows how the probe 1100 is used to obtain a biopsy in accordance with one embodiment. In other embodiments, alternative methods for obtaining the biopsy can be used, and any standard actuation system used in biopsy needle can be used. Firstly, the user operates either of the actuation triggers. Operation of one of the actuation triggers releases a latch to release a compressed spring, or spring system, within the probe body to cause the sheath which surrounds the needle to rapidly retract, exposing the notch of the needle to the tissue 217.

[0132] The user then presses either of the actuation triggers again, which releases a second latch to release a second spring, or spring system, which causes the sheath to rapidly extend (return to its original position). As the sheath returns, the tissue 217 is cut and a sample is retained on the notch, which is now protected by the sheath. Once the biopsy sample has been taken, the needle is removed from the patient.

[0133] On Figure 14(b), the biopsy sample is removed from the probe. To remove the biopsy sample, a user presses the spring loading trigger 219 and then presses either of the actuation triggers once. This causes the sheath to withdraw and enables the user to access the biopsy sample. Once the biopsy sample is removed, a user presses either of the actuation triggers for a second time to cause the sheath to return to its original position.

[0134] After removal of the probe from the patient, the sample can be removed and sent to a laboratory or subsequent analysis.

[0135] Figure 17 shows a perspective view of a casing 2000. The casing 2000 is open in Figure 17.

[0136] The casing 2000 acts as a docking station. The casing 2000 comprises two ports, each configured to receive an electronics module 1500. In other examples, the casing 2000 can comprise a single port, or any plurality of ports. The casing 2000 can be configured to charge the electronics modules 1500 through the once or more port(s), for example, via mains electricity or via a battery.

[0137] The casing 2000 comprises a UV light which, when the casing is closed 2000, illuminates the electronics modules 1500 with UV light so as to sterilize the electronics modules 1500. A user can place one electronics module 1500 into the casing 2000 whilst using the other electronics module 1500 and swap them whenever the power runs out or a new patient is tested. This can ensure that the probe is always usable as there is always a charged electronics module.

[0138] From reading the present disclosure, other variations and modifications will be apparent to the skilled person. Such variations and modifications may involve equivalent and other features which are already known in the art of biopsy probes and / or bioimpedance measurements, and which may be used instead of, or in addition to, features already described herein.

[0139] Although the appended claims are directed to particular combinations of features, it should be understood that the scope of the disclosure of the present invention also includes any novel feature or any novel combination of features disclosed herein either explicitly or implicitly or any generalisation thereof, whether or not it relates to the same invention as presently claimed in any claim and whether or not it mitigates any or all of the same technical problems as does the present invention.

[0140] Features which are described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. The applicant hereby gives notice that new claims may be formulated to such features and / or combinations of such features during the prosecution of the present application or of any further application derived therefrom.

[0141] For the sake of completeness, it is also stated that the term "comprising" does not exclude other elements or steps, the term "a" or "an" does not exclude a plurality, a single processor or other unit may fulfil the functions of several means recited in the claims and any reference signs in the claims shall not be construed as limiting the scope of the claims.

Claims

Claims1. A probe for obtaining a biopsy, the probe comprising: a biopsy needle; a pair of electrodes disposed on the biopsy needle; and an electronics module; wherein the electronics module is configured, in use, to apply a voltage across the pair of electrodes to obtain bioimpedance data.

2. The probe of claim 1 , wherein the electronics module comprises a transmitter configured to transmit the bioimpedance data to an external device.

3. The probe of any preceding claim, wherein the biopsy needle comprises a core and an insulating layer surrounding the core; and wherein the electrodes are disposed between the core and the insulating layer.

4. The probe of claim 3, wherein the electrodes extend from a tip of the needle to a base of the needle.

5. The probe of any preceding claim, wherein the electrodes are exposed at the tip of the needle and the base of the needle.

6. The probe of claim 5, wherein the electronics module is connectable to the electrodes via a connector, said connector comprising bond pads in electrical contact with the portion of the electrodes exposed at the base of the needle.

7. The probe of any preceding claim, wherein the electronics module is separable from the rest of the probe.

8. The probe of any preceding claim, wherein the biopsy needle comprises a retractable sheath.

9. The probe of claim 8, further comprising a first spring system configured, in use, to retract the sheath, and a second spring system configured, in use, to return the sheath to its original position.

10. The probe of claim 9, further comprising a spring compression trigger which enables a user to compress the first and second spring systems simultaneously.

11. The probe of any preceding claim, further comprising a first user-operable actuation trigger configured to release the first spring system from a compressed state and release the second spring system from a compressed state.

12. The probe of claim 11 , further comprising a second user-operable actuation trigger configured to release the first spring system from a compressed state and release the second spring system from a compressed state.

13. The probe of any preceding claim, further comprising a first user-operable measurement trigger configured to activate the electronics module to apply a voltage across the pair of electrodes to obtain bioimpedance data.

14. The probe of claim 13, further comprising a second user-operable measurement trigger configured to activate the electronics module to apply a voltage across the pair of electrodes to obtain bioimpedance data.

15. A system for obtaining a biopsy, the system comprising: a probe, the probe comprising: a biopsy needle comprising a pair of electrodes; and an electronics module comprising a transmitter; wherein the electronics module is configured, in use, to apply a voltage across the pair of electrodes to obtain bioimpedance data; and a console, the console comprising: a receiver configured to receive bioimpedance data transmitted by the transmitter; a console processor configured to analyse the bioimpedance data to provide a classification; and a feedback mechanism configured to communicate the classification to a user.

16. The system of claim 15, wherein the console processor performs the classification using an Elman neural network.

17. The system of claim 16, wherein feedback mechanism is a visual display.

18. The system of any of claims 15-17, wherein the probe is the probe of any of claims 2-14.

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