Techniques for assessing cancerous tissue during surgical biopsy

Abstract

In various embodiments, a medical device includes: a tissue sample receiving surface; an electrode array comprising a first electrode and a second electrode, the first electrode and the second electrode positioned to contact a tissue sample disposed on the tissue sample receiving surface; and an impedance bridge communicatively coupled to the electrode array.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 379,613, filed Oct. 14, 2022, and U.S. Patent Application No. 18 / 485,265, filed Oct. 11, 2023. The subject matter of these related applications is incorporated herein by reference. Technical Field

[0003] Embodiments of the present disclosure generally relate to electronic and medical diagnostic technologies, and more particularly to technologies for evaluating cancerous tissue during a surgical biopsy. Background Art

[0004] In traditional practice, to provide an accurate cancer diagnosis of a suspicious lesion, a doctor uses a forceps device or a needle device to collect one or more biopsy tissue samples from the suspicious lesion. The tissue samples are then sent to an external laboratory for pathological analysis, and the external laboratory may take several days or even weeks to provide a pathological assessment result to the doctor. Typically, a doctor collects multiple samples to increase the likelihood of capturing sufficient suspicious tissue for an accurate diagnosis. However, even so, there is still a significant possibility of insufficient sampling of the suspicious lesion, resulting in a non-diagnostic biopsy measurement where it is not possible to determine whether the lesion is cancerous or non-cancerous. For example, for many cancers, the proportion of non-diagnostic biopsy measurements can be as high as 40%. In fact, suspicious lesions are typically heterogeneous, and suspicious lesions are also typically not directly observable by a doctor, which are two reasons for the high proportion of non-diagnostic biopsy measurements. These problems compound to result in the above fact that doctors typically need to wait several days or even weeks to receive biopsy results.

[0005] Because timely diagnosis of many cancers is crucial for successful treatment, the ROSE (Rapid On-Site Evaluation) procedure has been developed to determine whether the quality of a biopsy tissue sample is sufficient for subsequent pathological analysis. In the ROSE procedure, a pathologist on-site performs a pathological analysis of the biopsy tissue as the doctor collects the biopsy tissue from the patient, thereby providing immediate feedback to the doctor performing the biopsy. In the event of a non-diagnostic or non-cancerous measurement, the procedure allows the doctor to perform additional biopsies and / or change the patient anatomical area from which the biopsy is taken.

[0006] One disadvantage of the ROSE procedure is that the procedure may alter or consume a large portion of each tissue sample tested. In this regard, ROSE pathologists typically prepare slides of tissue samples for microscopic evaluation by rubbing the tissue sample against a glass slide. Because the microscopic evaluation of the ROSE procedure benefits from having more tissue on the slide, a large portion of a given tissue sample is typically used to perform the procedure. As a result, the reliability of subsequent pathological analyses performed using the same given tissue sample may be adversely affected.

[0007] Another disadvantage of the ROSE procedure is that the procedure may interfere with the workflow of the physician performing the biopsy. While the ROSE procedure enables the biopsy physician to collect additional samples when a non-diagnostic tissue sample is encountered, pathological analysis of each sample results in a delay of approximately ten minutes or more. Therefore, if a large number of tissue samples are required to complete the ROSE procedure, the ROSE procedure may significantly interrupt the biopsy procedure. These types of interruptions may significantly increase the time required to perform and complete the biopsy procedure, which not only increases the clinical resources required to perform and complete the biopsy procedure, but is also extremely detrimental to the patient.

[0008] As noted above, what is needed in the art are more effective techniques for evaluating cancerous tissue during surgical biopsies. Summary of the invention

[0009] Embodiments of medical devices are disclosed. In various embodiments, a medical device includes: a tissue sample receiving surface; an electrode array including a first electrode and a second electrode positioned to contact a tissue sample disposed on the tissue sample receiving surface; and an impedance bridge communicatively coupled to the electrode array.

[0010] Embodiments of analyzing a tissue sample are disclosed. In various embodiments, a method includes: recording one or more impedance measurements associated with an electrode array included in a medical device at one or more frequencies, wherein the electrode array includes a first electrode and a second electrode, the first electrode contacts the tissue sample when the tissue sample is disposed on a tissue sample receiving surface, and the second electrode also contacts the tissue sample; determining a tissue type of the tissue sample based on the one or more impedance measurements; and causing an indicator of the tissue type to be displayed.

[0011] At least one technical advantage of the disclosed design and technology over the prior art is that the disclosed design and technology can provide immediate and real-time feedback to the clinician performing the surgical biopsy. Thus, when it is determined by the disclosed design and technology that a tissue sample is non-diagnostic, the clinician can immediately collect one or more additional tissue samples, thereby avoiding the long delays typically associated with diagnosing non-diagnostic tissue samples using conventional methods. In addition, because the disclosed design and technology can provide feedback to the doctor within a few seconds, the workflow of the surgical biopsy procedure is not significantly affected, and the duration of the surgical biopsy procedure is not significantly extended. Another technical advantage of the disclosed technology is that the tissue samples collected by the clinician are not altered, and thus the reliability of subsequent pathological analysis is not adversely affected. These technical advantages provide one or more technological advancements over prior art methods. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 Illustrates a medical device configured to implement one or more aspects of various embodiments.

[0013] Figure 2 is in accordance with various embodiments Figure 1 of the medical device in more detail.

[0014] Figure 3 is in accordance with various embodiments Figure 1 exploded view of the sample module adapter.

[0015] Figure 4 Illustrates placing a biopsy tissue sample on Figure 3 the biopsy sample strainer in accordance with various embodiments.

[0016] Figure 5A is in accordance with various embodiments Figure 3 more detailed illustration of the sample-facing surface of the medallion electrode array.

[0017] Figure 5B is in accordance with various embodiments Figure 3 more detailed illustration of the reverse surface of the medallion electrode array 320.

[0018] Figure 6 Schematically illustrates a tab electrode that can be used to contact a biopsy tissue sample in accordance with various embodiments.

[0019] Figure 7illustrates a scenario of placing a biopsy tissue sample on a sample-facing surface of a patch electrode according to various embodiments. Figure 6 of the patch electrode.

[0020] Figure 8 illustrates a scenario of Figure 1 a medical device juxtaposed with a first sample module adapter and a second sample module adapter according to various embodiments.

[0021] Figure 9 schematically illustrates a transparent electrode array that can be used to contact a biopsy tissue sample according to various embodiments.

[0022] Figure 10 is a flowchart of performing a biopsy procedure on a tissue sample according to various embodiments.

[0023] For clarity, where applicable, the same reference numerals are used to refer to the same elements common among the various figures. It is contemplated that features of one embodiment may be incorporated into other embodiments without further recitation. DETAILED DESCRIPTION

[0024] In the following description, numerous specific details are set forth to provide a more thorough understanding of the various embodiments. However, some embodiments include omitting one or more of these specific details within the scope of the conceptual embodiments.

[0025] System Overview

[0026] Figure 1 Illustrated is a medical device 100 configured to implement one or more aspects of various embodiments. The medical device 100 is capable of performing an in vitro real-time biopsy assessment on a tissue sample (e.g., a biopsy tissue sampled from a patient's anatomical region as part of a surgical biopsy procedure). Based on one or more bioimpedance biomarkers, the medical device 100 is capable of determining the tissue type of the tissue sample, thereby providing immediate feedback to the clinician performing the surgical biopsy procedure. As described in more detail below, the medical device 100 determines the tissue type of a particular tissue sample based on impedance measurements of that particular tissue sample. As a result, the clinician can learn within seconds whether the particular sample comprises cancerous tissue, non-cancerous tissue, or pre-cancerous tissue. Additionally, this process minimally or not at all disrupts the workflow of the surgical biopsy procedure. As shown, the medical device 100 includes, but is not limited to: a sample module 120, a sample module adapter 130, an impedance bridge 140, a digitizing circuit 150, a controller 160, and an input / output (I / O) device 170.

[0027] The sample module 120 holds a tissue sample (not shown) and brings the tissue sample into contact with a first electrode 121 and a second electrode 122 in the electrode array 126, enabling impedance scanning of the tissue sample. In Figure 1 the illustrated embodiment, the sample module 120 includes a tissue sample receiving surface 125 and an electrode array 126. For impedance scanning, the tissue sample is placed on the tissue sample receiving surface 125 and brought into contact with the first electrode 121 and the second electrode 122 in the electrode array 126. Generally, the sample module 120 is included in a sample module adapter 130.

[0028] The sample module adapter 130 communicatively couples the sample module 120 to the impedance bridge 140. Thus, the sample module adapter 130 electrically couples the first electrode 121 and the second electrode 122 to appropriate electrical contacts associated with the impedance bridge 140. In some embodiments, the medical device 100 can use multiple different configurations of the sample module 120. In such embodiments, a first sample module adapter 130 is configured to communicatively couple a first configuration of the sample module 120 to the impedance bridge 140, a second sample module adapter 130 is configured to communicatively couple a second configuration of the sample module 120 to the impedance bridge 140, and so on. In this way, the medical device 100 can utilize multiple different configurations of the sample module 120. Various embodiments of the sample module 120 and the sample module adapter 130 will be described below in connection with Figures 2 to 9 this.

[0029] The impedance bridge 140 can be an impedance load that the controller 160 measures to determine the impedance of a circuit including the impedance bridge 140, an amplifier (if present), and the electrode array 126. For example, in some embodiments, when the first electrode 121 and the second electrode 122 of the electrode array 126 contact a tissue sample on the sample receiving surface 125, the controller 160 generates the frequency of a current flowing in a circuit including the impedance bridge 140 and the electrode array 126. In various embodiments, the impedance bridge 140 also includes an amplifier (not shown), which is an analog interface amplifier for amplifying the provided voltage and / or the return voltage when current flows between the impedance bridge 140 and the electrode array 126 at various frequencies. It is noted that when the tissue sample contacts the first electrode 121 and the second electrode 122 of the electrode array 126, the impedance bridge 140 and the electrode array 126 form a circuit, the sample module 120 is disposed in the sample module adapter 130, and the sample module adapter 130 is coupled to the medical device 100. The digitization circuit 150 digitizes the signals in this circuit to enable the operation of the controller 160.

[0030] The controller 160 includes a processing unit 161 and a memory 162, and executes one or more operations to implement the various embodiments described herein. For example, in some embodiments, the controller 160 executes a program stored in the memory 162 to perform a plurality of specific electrical measurements on a tissue sample using the first electrode 121 and the second electrode 122 of the electrode array 126. In some embodiments, the controller 160 may receive instructions from a user via the I / O device 170 to perform electrical measurements using the electrode array 126, such as one or more impedance measurements 163. In some embodiments, the controller 160 may receive instructions from a user via the I / O device 170 to store data, such as data associated with one or more impedance measurements 163. In some embodiments, the stored data associated with the impedance measurements 163 includes measured electrical characteristics determined by a measurement circuit including the impedance bridge 140 and the electrode array 126. For example, in some embodiments, the controller 160 stores the measured voltage and measured current of an input signal at a specific operating frequency.

[0031] In some embodiments, the controller 160 determines a determined tissue type 164 of a tissue sample in contact with the first electrode 121 and the second electrode 122. In this embodiment, the determined tissue type is based on one or more impedance measurements 163 associated with the sample in contact with the first electrode 121 and the second electrode 122. In various embodiments, the controller 160 determines the determined tissue type 164 by comparing the impedance measurements 163 with one or more characteristic impedance measurements associated with one or more tissue types. For example, but not limited to, based on the comparison, the controller 160 may determine which tissue type is associated with the characteristic impedance measurement that is closest to the impedance measurement 163 of the sample tissue in contact with the first electrode 121 and the second electrode 122.

[0032] In various embodiments, the controller 160 may determine the Cole relaxation frequency of a tissue sample based on the impedance measurements 163. Specifically, the controller 160 calculates the Cole relaxation frequency of the tissue sample based on the calculated impedance corresponding to the operating frequency, where the Cole relaxation frequency of the tissue sample reflects the rate at which the cell membrane releases stored charge. In this embodiment, the controller 160 compares the Cole relaxation frequency with the characteristic Cole relaxation frequencies of one or more tissue types. The Cole relaxation frequency of a specific tissue sample corresponds to the frequency associated with the maximum impedance measurement 163 included in one or more impedance measurements 163 of the specific tissue sample. In various embodiments, the Cole relaxation frequency is the frequency of the maximum normalized impedance measurement of the tissue sample in contact with the first electrode 121 and the second electrode 122.

[0033] Due to the significant differences in the electrical properties between malignant and non-malignant cells, the Cole relaxation frequency of malignant cells is more than a thousand times smaller than that of non-malignant cells. Thus, in some embodiments, based on the Cole relaxation frequency being lower than a lower threshold frequency (e.g., 105 Hz), the controller 160 can determine that the tissue sample in contact with the first electrode 121 and the second electrode 122 is of a non-tumor tissue type (also referred to as non-cancerous tissue). Similarly, in some embodiments, based on the Cole relaxation frequency being higher than a higher threshold frequency, the controller 160 can determine that the tissue sample in contact with the first electrode 121 and the second electrode 122 is of a tumor tissue type (also referred to as cancerous tissue). Additionally, for example but not limited to, based on the Cole relaxation frequency being between a lower threshold frequency (e.g., 500 kHz) and a higher threshold frequency (e.g., 1 MHz), the controller 160 can determine that the tissue sample in contact with the first electrode 121 and the second electrode 122 is pre-cancerous tissue.

[0034] In some embodiments, the processing unit 161 can be a single central processing unit (CPU), or can be a combination of multiple processing units. The processing unit 161 can be any technically feasible hardware unit capable of processing data and / or executing software code. In some embodiments, the processing unit 161 receives instructions from a user via the I / O device 170 and / or from the memory 162, and executes these instructions. In some embodiments, the processing unit 161 implements one or more techniques performed by the controller 160. In some embodiments, the memory 162 is configured to store data and / or software applications. The memory 162 can include random access memory (RAM) modules, hard disks, flash memory units, or any other type of memory unit, or a combination thereof. The controller 160 and the I / O unit 130 are configured to read data from the memory 162 and write data to the memory 162.

[0035] The input / output (I / O) device 170 can include devices capable of receiving one or more inputs, including a keyboard, a mouse, a tablet, a camera, and / or a three-dimensional (3D) scanner. In some embodiments, the I / O device 170 can also include devices capable of providing one or more outputs, such as, a speaker, a printer, or a display 171. The display 171 displays data generated by the medical device 100. In an embodiment, the display 171 displays one or more of the calculated Cole relaxation frequency and / or the determined tissue type 164. In some embodiments, the display 171 can refresh the data generated by the medical device 100 when the medical device 100 performs measurements on a particular tissue sample. The I / O device 170 can also include devices capable of receiving inputs and providing outputs, such as, a touch screen and a universal serial bus (USB) port.

[0036] Figure 2FIG. 0 is a more detailed illustration of a medical device 100 according to various embodiments. As shown, the medical device 100 includes, but is not limited to, a tabletop housing 201, a display 220, and a sample module adapter 230. Figure 2 A display output 221 is also shown, which includes a graphical user interface 229. In Figure 2 the illustrated embodiment, the graphical user interface 229 includes, but is not limited to: patient-specific information 222 of a patient associated with a tissue sample, a graphical representation 223 of a scan result of the tissue sample, a text result 224 of the scan of the tissue sample, and one or more interaction buttons 225 for receiving user input. In Figure 2 the illustrated embodiment, the medical device 100 includes a barcode scanner 226 for inputting patient information.

[0037] Disk-shaped electrode embodiment

[0038] Figure 3 FIG. 13 is an exploded view of a sample module adapter 230 according to various embodiments. The sample module adapter 230 is configured to position a disk-shaped electrode array 320 such that a tissue sample (not shown) contacts a first electrode 321 and a second electrode 322 of the disk-shaped electrode array 320. The sample module adapter 230 is also configured to communicatively couple the disk-shaped electrode array 320 and the tissue sample to Figure 1 an impedance bridge 140 in FIG. 14. As shown, the sample module adapter 230 includes, but is not limited to: a compressed tissue sample holder 331, a disk-shaped electrode array 320, a biopsy sample filter screen 332, a filter screen alignment feature 333 for positioning the biopsy sample filter screen 332, an electrical contact 333, and a housing 334.

[0039] When the compressed tissue sample holder 331 is mounted onto the housing 334 covering the disk-shaped electrode array 320, the compressed tissue sample holder 331 presses the disk-shaped electrode array 320 against a tissue sample (not shown) disposed on a tissue sample receiving surface 335 of the sample module adapter 230. In Figure 3 the illustrated embodiment, the tissue sample receiving surface 335 is the top surface of a biopsy sample filter screen 332, which is operatively coupled to the filter screen alignment feature 333 during operation. The compressed tissue sample holder 331 includes an electrical conductor (not shown), which electrically couples the disk-shaped electrode array 320 to Figure 1 the impedance bridge 140 in FIG. 14, for example, via the electrical contact 333. The biopsy sample filter screen 332 is positioned within the disk-shaped electrode array 320 via the filter screen alignment feature 333. During operation, when the compressed tissue sample holder 331 is coupled to the housing 334 of the disk-shaped electrode array 320, the tissue sample is flushed onto the biopsy sample filter screen 332, and the first electrode 321 and the second electrode 322 contact the tissue sample.Figure 4 A scenario of placing a biopsy tissue sample on the biopsy sample filter screen 332 is shown.

[0040] Figure 4 A scenario of placing a biopsy tissue sample 401 on the biopsy sample filter screen 332 according to various embodiments is shown. The biopsy tissue sample 401 can be collected using a needle biopsy syringe 402 and placed on the biopsy sample filter screen 332 after collection, as shown in the figure. The compression tissue sample holder 331 (not shown in Figure 4 ) is removed from the housing 334 so that the tissue sample receiving surface 335 of the biopsy sample filter screen 332 is accessible.

[0041] Returning to Figure 3 , the disk-shaped electrode array 320 includes a first electrode 321 and a second electrode 322. In the Figure 3 illustrated embodiment, a portion of the first electrode 321 is disposed on the sample-facing surface 336 (not shown in Figure 3 ) of the disk-shaped electrode array 320, and another portion of the first electrode 321 is disposed on the reverse surface 337 of the disk-shaped electrode array 320. Similarly, a portion of the second electrode 322 is disposed on the sample-facing surface 336, and another portion of the second electrode 322 is disposed on the reverse surface 337. Embodiments of the disk-shaped electrode array 320 will be described in more detail below in conjunction with Figure 5A and Figure 5B .

[0042] Figure 5A is a plan view of the sample-facing surface 336 of the disk-shaped electrode array 320 according to various embodiments, and Figure 5B is a plan view of the reverse surface 337 of the disk-shaped electrode array 320 according to various embodiments. As shown, a portion of the first electrode 321 is disposed on the sample-facing surface 336, and another portion (represented by cross-hatching) of the first electrode 321 is also disposed on the reverse surface 337 of the disk-shaped electrode array 320. Similarly, a portion of the second electrode 322 is disposed on the sample-facing surface 336, and another portion (represented by cross-hatching) of the second electrode 322 is also disposed on the reverse surface 337 of the disk-shaped electrode array 320. To facilitate sufficient electrical contact with the tissue sample disposed on the tissue sample receiving surface 335 of the sample module adapter 230 (as shown in Figure 3 ), the portion of the first electrode 321 disposed on the sample-facing surface 336 includes a plurality of electrode elements, and the portion of the second electrode 322 disposed on the sample-facing surface 336 also includes a plurality of electrode elements. In Figure 5AIn the illustrated embodiment, the electrode elements included in the first electrode 321 and disposed on the sample-facing surface 336 are arranged in a crossed pattern with the electrode elements included in the second electrode 322 and disposed on the sample-facing surface 336.

[0043] In some embodiments, in order to enable the disc-shaped electrode array 320 to be arranged in any rotational direction, the disc-shaped electrode array 320 is configured to be circular. In addition, the portion of the first electrode 321 disposed on the reverse surface 337 is radially offset from the portion of the second electrode 322 disposed on the reverse surface 337. Thus, regardless of the rotational direction of the disc-shaped electrode array 320, the disc-shaped electrode array 320 can be electrically connected to the conductor included in the compressed tissue sample holder 331. For example, in Figure 5B the illustrated embodiment, the portion of the first electrode 321 disposed on the reverse surface 337 is located at the center position of the reverse surface 337, and a portion of the second electrode 322 is formed as a ring disposed on the reverse surface 337 and extending radially outward from the portion of the first electrode 321.

[0044] Patch Electrode Embodiment

[0045] In some embodiments, impedance measurements of tissue samples are collected via patch electrodes. In these embodiments, patch electrodes are used to make electrical contact with the tissue samples instead of using disc-shaped electrodes. One of the embodiments will be described below in conjunction with Figure 6 to describe one of the embodiments.

[0046] Figure 6 Schematically shown is a patch electrode 600 capable of contacting a biopsy tissue sample (not shown) according to various embodiments. As shown, the patch electrode 600 includes a first electrode 621 and a second electrode 622. The first electrode 621 includes a plurality of electrode elements electrically coupled to each other via first edge electrode elements 631, and the second electrode 622 includes a plurality of electrode elements electrically coupled to each other via second edge electrode elements 632. Similar to Figure 3 the disc-shaped electrode array 320 in Figure 6 the illustrated embodiment, the electrode elements included in the first electrode 621 are arranged in a crossed pattern with the electrode elements included in the second electrode 622. Different from the disc-shaped electrode array 320, the electrode elements included in the first electrode 621 and the electrode elements included in the second electrode 622 are both formed on the sample-facing surface 636. Thus, in operation, when a tissue sample (not shown) is placed on the sample-facing surface 636, the first electrode 621 and the second electrode 622 contact the tissue sample. Figure 7 Shows a scenario where a biopsy tissue sample is placed on the sample-facing surface 636.

[0047] Figure 7Illustrates a scenario of placing a biopsy tissue sample 701 on the sample-facing surface 636 of a patch electrode 600 according to various embodiments. The biopsy tissue sample 701 can be collected using a needle biopsy syringe 702 and placed on the sample-facing surface 636 after collection, as shown in the figure. Figure 7 Also illustrated is the patch electrode 600 coupled to a sample module adapter 730, which is configured to receive the patch electrode 600 and is shown coupled to Figure 7 the medical device 100 in Figure 2 the sample module adapter 230 in Figure 7 and the sample module adapter 730 in Figure 8 One of the embodiments will be described below in conjunction with

[0048] Figure 8 Illustrates a scenario of the medical device 100 juxtaposed with a first sample module adapter 831 and a second sample module adapter 832 according to various embodiments. In some embodiments, the first sample module adapter 831 is consistent with Figure 2 the sample module adapter 230 in Figure 7 and the second sample module adapter 832 is consistent with

[0049] Transparent Electrode Embodiments

[0050] In some embodiments, impedance measurements of a tissue sample are collected via a transparent electrode array disposed on an optically transparent substrate. In these embodiments, the optically transparent substrate can be used as a microscope slide. One of the embodiments will be described below in conjunction with Figure 9

[0051] Figure 9 Schematically illustrates a transparent electrode array 920 capable of contacting a biopsy tissue sample 901 according to various embodiments. The array 920 includes a first electrode 921 and a second electrode 922 and is formed or deposited on a transparent substrate 902. As shown, the array 920 also includes an electrical connection 903 to Figure 1 the impedance bridge 140 in

[0052] In Figure 9 ​In the illustrated embodiment, the first electrode 921 includes two transparent electrode elements electrically coupled to each other via a first common electrode element (not shown for clarity), and the second electrode 922 includes two transparent electrode elements electrically coupled to each other via a second common electrode element (not shown for clarity). In some embodiments, the transparent electrode elements of the first electrode 921 and the second electrode 922 include one or more conductive transparent materials, such as, for example, titanium nitride and / or indium tin oxide. In these embodiments, since the first electrode 921 and the second electrode 922 are substantially transparent to visible light, a transparent substrate 902 can be used as an optical microscope slide. Thus, impedance measurements of the biopsy tissue sample 901 can be performed when the biopsy tissue sample 901 is placed on the transparent substrate 902. Further, since the first electrode 921 and the second electrode 922 do not interfere with the microscope-based pathological evaluation of the biopsy tissue sample 901, a conventional microscope-based pathological evaluation of the biopsy tissue sample 901 can be performed without removing the biopsy tissue sample 901 from the transparent substrate 902.

[0053] Method for Evaluating Cancerous Tissue During Surgical Biopsy

[0054] Figure 10 is a flowchart of performing a biopsy procedure on a tissue sample according to various embodiments. Although the method steps are described in conjunction with Figures 1 to 8 the system in, those skilled in the art will understand that any system configured to perform the method steps in any order falls within the scope of the present disclosure.

[0055] As shown, method 1000 begins at step 1002, where a biopsy sample is obtained from a patient's anatomical region (e.g., a target lesion). In some cases, the lesion is imaged so that the location of the target lesion can be determined. For example, in some cases, the patient's anatomical region can be imaged via X-ray, ultrasound, and / or magnetic resonance imaging (MRI). Then, a suitable biopsy procedure is used to obtain the biopsy sample, where the suitable biopsy procedure can be determined based on the location of the target lesion and / or the general region of the patient's anatomy of interest. Examples of these biopsy procedures include needle biopsy, endoscopic biopsy, skin biopsy, bone marrow biopsy, surgical biopsy, and the like. Generally, a needle or a hollow tube is used to obtain a specific biopsy sample from the anatomical region or the target lesion.

[0056] In step 1004, the biopsy sample is placed on the sample receiving surface 125 of the sample module 120. For example, in some cases, the biopsy sample (e.g., a biopsy core from a needle biopsy syringe) is rinsed with saline onto the tissue sample receiving surface 335 of the sample module adapter 230. Alternatively, the biopsy sample can be rinsed onto the sample-facing surface 636 of the patch electrode 600 or onto the transparent substrate 902.

[0057] In step 1006, the sample module 120 with the biopsy core placed therein is coupled to a suitable sample module adapter 130, e.g., the sample module adapter 230 or the sample module adapter 730. In some embodiments, a detachable compressed tissue sample holder is first used to press the electrode array of the sample module 120 against the biopsy sample disposed on the tissue sample receiving surface 125 of the sample module 120.

[0058] In step 1008, one or more impedance measurements 163 of the biopsy sample are performed using the medical device 100. As previously described, one or more impedance measurements 163 are performed and recorded at one or more frequencies via the controller 160, the impedance bridge 140, and the electrode array 126.

[0059] In step 1010, the controller 160 determines the determined tissue type 164 of the biopsy sample based on the (one or more) impedance measurements 163 performed in step 1008. In some embodiments, the determined tissue type 164 is further determined based on comparing the Cole relaxation frequency of the biopsy sample with one or more characteristic Cole relaxation frequencies of one or more tissue types. In these embodiments, the comparison can be based on a single threshold frequency or can be based on a lower threshold frequency and a higher threshold frequency.

[0060] In embodiments where a single threshold frequency is compared, the controller 160 determines that the determined tissue type 164 is non-cancerous when the Cole relaxation frequency of the biopsy sample is lower than the single threshold frequency; and determines that the determined tissue type 164 is cancerous when the Cole relaxation frequency of the biopsy sample is higher than the single threshold frequency. Alternatively, in embodiments where a lower threshold frequency and a higher threshold frequency are compared, the controller determines that the determined tissue type 164 is non-cancerous when the Cole relaxation frequency of the biopsy sample is lower than the lower threshold frequency; determines that the determined tissue type 164 is cancerous when the Cole relaxation frequency of the biopsy sample is higher than the higher threshold frequency; and determines that the determined tissue type 164 is pre-cancerous when the Cole relaxation frequency of the biopsy sample is higher than the lower threshold frequency and lower than the higher threshold frequency. It should be noted that the threshold frequencies typically vary based on the specific tissue type and can be determined experimentally. For example, the threshold frequency of pancreatic tissue can be significantly different from that of bone marrow tissue, skin tissue, lung tissue, and so on.

[0061] In step 1012, the controller 160 causes one or more indicators of the determined tissue type 164 to be displayed. For example, in some embodiments, the controller 160 causes a graphical representation 223 of the biopsy sample results to be displayed via the display 171. Alternatively or additionally, in some embodiments, the controller 160 causes a text result 224 of the biopsy sample results to be displayed via the display 171.

[0062] In summary, the embodiments described herein are capable of determining the tissue type of a tissue sample. Based on performing an in vitro impedance measurement on the tissue sample, a medical device can determine whether the tissue sample is cancerous, non-cancerous, or pre-cancerous. Using an impedance bridge to perform the impedance measurement does not alter or consume the tissue sample, and the electrode array of the medical device is configured with cross-arranged electrode elements to facilitate electrical connection with the tissue sample during the measurement.

[0063] At least one technical advantage of the disclosed design and technology over the prior art is that the disclosed design and technology can provide immediate, real-time feedback to a clinician performing a surgical biopsy. Thus, when it is determined by the disclosed design and technology that a tissue sample is non-diagnostic, the clinician can immediately collect one or more additional tissue samples, thereby avoiding the long delays typically associated with diagnosing non-diagnostic tissue samples using traditional methods. Additionally, since the disclosed design and technology can provide feedback to the doctor within a few seconds, the workflow of the surgical biopsy procedure is not significantly affected, and the duration of the surgical biopsy procedure is not significantly extended. Another technical advantage of the disclosed technology is that the tissue samples collected by the clinician are not altered, so the reliability of subsequent pathological analysis is not adversely affected. These technical advantages provide one or more technological advancements over prior art methods.

[0064] 1. In an embodiment, a medical device includes: a tissue sample receiving surface; an electrode array including a first electrode and a second electrode, the first electrode and the second electrode being positioned to contact a tissue sample disposed on the tissue sample receiving surface; and an impedance bridge communicatively coupled to the electrode array.

[0065] 2. The medical device according to clause 1, wherein the first electrode includes a first plurality of electrode elements, and the second electrode includes a second plurality of electrode elements.

[0066] 3. The medical device according to clause 1 or 2, wherein the electrode elements in the first plurality of electrode elements are arranged in a cross pattern between the electrode elements in the second plurality of electrode elements.

[0067] 4. The medical device according to any one of clauses 1 to 3, wherein the tissue sample receiving surface is disposed on an optically transparent substrate.

[0068] 5. The medical device according to any one of clauses 1 to 4, wherein the tissue sample receiving surface is disposed on an optically transparent substrate, and the electrode array is disposed on the tissue sample receiving surface.

[0069] 6. The medical device according to any one of clauses 1 to 5, wherein the first electrode and the second electrode are transparent to visible light.

[0070] 7. The medical device according to any one of clauses 1 to 6, wherein the electrode array is disposed on the tissue sample receiving surface.

[0071] 8. The medical device according to any one of clauses 1 to 7, further comprising: a detachable compression tissue sample holder that presses the electrode array against a tissue sample disposed on the tissue sample receiving surface.

[0072] 9. The medical device according to any one of clauses 1 to 8, wherein the detachable compression tissue sample holder includes one or more electrical conductors that communicatively couple the impedance bridge and the electrode array.

[0073] 10. The medical device according to any one of clauses 1 to 9, further comprising: an adapter opening that selectively receives a first sample module adapter for accommodating a tissue sample or a second sample module adapter for accommodating a tissue sample.

[0074] 11. The medical device according to any one of clauses 1 to 10, wherein the first sample module adapter includes the tissue sample receiving surface and a detachable compressed tissue sample holder that presses the electrode array against a tissue sample disposed on the tissue sample receiving surface.

[0075] 12. The medical device according to any one of clauses 1 to 11, wherein the second sample module adapter includes the tissue sample receiving surface, and the electrode array is disposed on the tissue sample receiving surface.

[0076] 13. The medical device according to any one of clauses 1 to 12, further comprising: a controller that, during operation, performs the following steps: recording one or more impedance measurements associated with the electrode array at one or more frequencies when the first electrode and the second electrode contact the tissue sample; determining a tissue type of the tissue sample based on the one or more impedance measurements; and causing an indicator indicating the tissue type to be displayed.

[0077] 14. The medical device according to any one of clauses 1 to 13, wherein determining the tissue type includes: comparing the one or more impedance measurements with one or more characteristic impedance measurements associated with one or more tissue types.

[0078] 15. In some embodiments, a method for analyzing a tissue sample, the method comprising: recording one or more impedance measurements associated with an electrode array included in a medical device at one or more frequencies, wherein the electrode array includes a first electrode and a second electrode, the first electrode contacting the tissue sample when the tissue sample is disposed on a tissue sample receiving surface, and the second electrode also contacting the tissue sample; determining a tissue type of the tissue sample based on the one or more impedance measurements; and causing an indicator indicating the tissue type to be displayed.

[0079] 16. The method according to clause 15, wherein the tissue type is selected from the group consisting of cancerous tissue, non-cancerous tissue, and pre-cancerous tissue.

[0080] 17. The method according to clause 15 or 16, wherein determining the tissue type includes: comparing the one or more impedance measurements with one or more characteristic impedance measurements associated with one or more tissue types.

[0081] 18. The method according to any one of clauses 15 to 17, wherein determining the tissue type includes: determining the Cole relaxation frequency of a tissue part based on the one or more impedance measurements, and comparing the Cole relaxation frequency of the tissue part with one or more characteristic Cole relaxation frequencies of one or more tissue types.

[0082] 19. The method according to any one of clauses 15 to 18, wherein the Cole relaxation frequency corresponds to the frequency associated with the maximum impedance measurement included in the one or more impedance measurements.

[0083] 20. The method according to any one of clauses 15 to 19, wherein the indicator is displayed on a display device associated with the medical device.

[0084] Any and all combinations of any claim elements recited in any claim and / or any elements described in the present application fall within the scope contemplated by the present invention and protection in any way.

[0085] The description of various embodiments has been presented for purposes of illustration, but is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments.

[0086] Aspects of the embodiments of the present application may be embodied as a system, a method, or a computer program product. Accordingly, aspects of the present disclosure may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining software and hardware aspects, which may all generally be referred to herein as a "module", "system", or "computer". Additionally, any hardware and / or software techniques, processes, functions, components, engines, modules, or systems described in the present disclosure may be implemented as a circuit or a group of circuits. Furthermore, aspects of the present disclosure may take the form of a computer program product embodied in one or more computer-readable media, with computer-readable program code embodied thereon.

[0087] Any combination of one or more computer-readable media can be utilized. A computer-readable medium can be either a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium can be, by way of example and not limitation, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer-readable storage medium would include the following media: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing media. In the context of this document, a computer-readable storage medium can be any tangible medium that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0088] Aspects of the present disclosure are described above with reference to the flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present disclosure. It should be understood that each block of the flowcharts and / or block diagrams, and combinations of blocks in the flowcharts and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine. When the instructions are executed by a processor of a computer or other programmable data processing apparatus, the instructions enable the implementation of the functions / acts specified in one or more blocks of the flowchart and / or block diagram. Such a processor can be, but is not limited to, a general purpose processor, a special purpose processor, an application specific processor, or a field programmable gate array.

[0089] The flowcharts and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present disclosure. In this regard, each block in the flowchart or block diagram may represent a module, segment, or portion of code, which includes one or more executable instructions for implementing the specified logical function. It should also be noted that, in some alternative implementations, the functions noted in the blocks may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It should also be noted that each block of the block diagrams and / or flowcharts, and combinations of blocks in the block diagrams and / or flowcharts, can be implemented by a system based on dedicated hardware for performing the specified functions or acts, or by a combination of dedicated hardware and computer instructions.

[0090] Although the foregoing relates to embodiments of the present disclosure, other and additional embodiments of the present disclosure may be devised without departing from the basic scope thereof, and the scope of the present disclosure is determined by the appended claims.

Claims

1. A medical device, comprising: A tissue sample receiving surface; An electrode array including a first electrode and a second electrode, the first electrode and the second electrode being positioned to contact a tissue sample disposed on the tissue sample receiving surface; And An impedance bridge communicatively coupled to the electrode array.

2. The medical device according to claim 1, wherein The first electrode includes a first plurality of electrode elements, and the second electrode includes a second plurality of electrode elements.

3. The medical device according to claim 2, wherein, The electrode elements in the first plurality of electrode elements are arranged crosswise between the electrode elements in the second plurality of electrode elements.

4. The medical device according to claim 1, wherein, The tissue sample receiving surface is disposed on an optically transparent substrate.

5. The medical device according to claim 1, wherein, The tissue sample receiving surface is disposed on an optically transparent substrate, and the electrode array is disposed on the tissue sample receiving surface.

6. The medical device according to claim 5, wherein, The first electrode and the second electrode are transparent to visible light.

7. The medical device according to claim 1, wherein, The electrode array is disposed on the tissue sample receiving surface.

8. The medical device according to claim 1, further comprising: A detachable compression tissue sample holder that presses the electrode array against a tissue sample disposed on the tissue sample receiving surface.

9. The medical device according to claim 8, wherein, The detachable compression tissue sample holder includes one or more electrical conductors that communicatively couple the impedance bridge and the electrode array.

10. The medical device according to claim 1 further comprises: An adapter opening that selectively receives a first sample module adapter for accommodating a tissue sample or a second sample module adapter for accommodating a tissue sample.

11. The medical device according to claim 10, wherein, The first sample module adapter includes the tissue sample receiving surface and a detachable compression tissue sample holder that presses the electrode array against a tissue sample disposed on the tissue sample receiving surface.

12. The medical device according to claim 10, wherein, The second sample module adapter includes the tissue sample receiving surface, and the electrode array is disposed on the tissue sample receiving surface.

13. The medical device according to claim 1 further comprises: A controller that performs the following steps during operation: When the first electrode and the second electrode contact the tissue sample, record one or more impedance measurements associated with the electrode array at one or more frequencies; Based on the one or more impedance measurements, determine the tissue type of the tissue sample; and And Cause an indicator of the tissue type to be displayed.

14. The medical device according to claim 1, wherein, Determining the tissue type includes: comparing the one or more impedance measurements with one or more characteristic impedance measurements associated with one or more tissue types.

15. A method for analyzing a tissue sample, the method comprising: Record one or more impedance measurements associated with an electrode array included in a medical device at one or more frequencies, wherein the electrode array includes a first electrode and a second electrode, the first electrode contacting the tissue sample when the tissue sample is disposed on a tissue sample receiving surface, and the second electrode also contacting the tissue sample; Based on the one or more impedance measurements, determine the tissue type of the tissue sample; and Cause an indicator of the tissue type to be displayed.

16. The method according to claim 15, wherein, The tissue type is selected from the group including cancerous tissue, non-cancerous tissue, and pre-cancerous tissue.

17. The method according to claim 15, wherein Determining the tissue type includes: comparing the one or more impedance measurements with one or more characteristic impedance measurements associated with one or more tissue types.

18. The method according to claim 15, wherein, Determining the tissue type includes: Based on the one or more impedance measurements, determining a Cole relaxation frequency of the tissue portion, and comparing the Cole relaxation frequency of the tissue portion with one or more characteristic Cole relaxation frequencies of one or more tissue types.

19. The method according to claim 18, wherein, The Cole relaxation frequency corresponds to the frequency associated with the maximum impedance measurement included in the one or more impedance measurements.

20. The method according to claim 15, wherein, The indicator is displayed on a display device associated with the medical device.

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