Techniques for assessing cancer tissue during surgical biopsy

Abstract

In various embodiments, the 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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 379,613, filed October 14, 2022, and U.S. Patent Application No. 18 / 485,265, filed October 11, 2023. The subject matter of these related applications is incorporated herein by reference. [Technical Field]

[0002] FIELD OF THE DISCLOSURE Embodiments of the present disclosure relate generally to electronics and medical diagnostic technology, and more particularly to technology for assessing cancerous tissue during surgical biopsy. [Background technology]

[0003] In conventional practice, to accurately diagnose a suspicious lesion for cancer, a physician obtains one or more biopsy tissue samples from the suspicious lesion using either a forceps or needle device. The tissue samples are then sent to an external laboratory for pathology analysis, but the pathology evaluation may not be provided to the physician for days or weeks. Typically, physicians obtain multiple samples to increase the likelihood of obtaining sufficient suspicious tissue for an accurate diagnosis. However, there is still a relatively high likelihood of not obtaining an adequate sample of the suspicious lesion, resulting in a non-diagnostic biopsy measurement that fails to indicate whether the lesion is cancerous or non-cancerous. For example, for many cancers, the rate of non-diagnostic biopsy measurements can be as high as 40%. The heterogeneity of suspicious lesions and the fact that suspicious lesions are typically not directly visible to physicians are two reasons for the high percentage of non-diagnostic biopsy measurements. These problems combine to mean that physicians must typically wait days or weeks to receive biopsy results.

[0004] Because timely diagnosis of many cancers is essential for successful treatment, the ROSE (Rapid Examination of Situations with Cytology) method was developed to determine whether the quality of a biopsy tissue sample is sufficient for subsequent pathology analysis. In the ROSE method, an on-site pathologist performs the pathology analysis at the time the biopsy tissue is removed from the patient by the physician, thereby providing more immediate feedback to the physician performing the biopsy. This method allows the physician to perform additional biopsies and / or change the location of the patient's body where the biopsy is performed if non-diagnostic or non-cancerous measurements are obtained.

[0005] One drawback of the ROSE technique is that it can alter or consume a significant portion of each tissue sample examined. In this regard, ROSE pathologists typically prepare tissue sample slides for microscopic evaluation by rubbing the tissue sample against a slide. Because microscopic evaluation of the ROSE technique benefits from having more tissue on the slide, a significant portion of a given tissue sample is often used to perform the technique. This can adversely affect the reliability of subsequent pathology analyses performed using the same given tissue sample.

[0006] Another drawback of the ROSE procedure is that it can disrupt the workflow of the physician performing the biopsy. While the ROSE procedure allows the biopsy physician to collect additional samples in response to non-diagnostic tissue samples, pathological analysis of each sample is delayed by approximately 10 minutes or more. Therefore, the ROSE procedure can significantly disrupt the biopsy procedure, especially when multiple tissue samples are required to complete the ROSE procedure. These types of disruptions substantially increase the time required to perform and complete the biopsy procedure, increase the clinical resources required to perform and complete the biopsy procedure, and are highly undesirable for patients. Summary of the Invention [Problem to be solved by the invention]

[0007] As has been shown, there is a need for more effective techniques for evaluating tissue samples during surgical biopsy. [Means for solving the problem]

[0008] Embodiments of a medical device are disclosed. In various embodiments, the 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.

[0009] Embodiments of a method for analyzing a tissue sample are disclosed. In various embodiments, the method includes recording one or more impedance measurements at one or more frequencies associated with an electrode array included in a medical device, the electrode array including a first electrode contacting the tissue sample while positioned on a tissue sample receiving surface and a second electrode contacting the tissue sample, identifying a tissue type of the tissue sample based on the one or more impedance measurements, and displaying an indicia of the tissue type.

[0010] At least one technical advantage of the disclosed designs and techniques over conventional examples is that the disclosed designs and techniques provide immediate, real-time feedback to the clinician performing the surgical biopsy. Consequently, if a tissue sample is identified as non-diagnostic via the disclosed designs and techniques, the clinician may immediately collect one or more additional tissue samples, thereby avoiding the long delays in diagnosing non-diagnostic tissue samples that are typical with conventional approaches. Furthermore, because the disclosed designs and techniques provide feedback to the physician within seconds, the workflow of the surgical biopsy procedure is not substantially affected, and the duration of the surgical biopsy procedure is not significantly extended. A further technical advantage of the disclosed techniques is that the tissue sample collected by the clinician is not altered, thereby not adversely affecting the reliability of subsequent pathology analysis. These technical advantages provide one or more technical advantages over conventional approaches. [Brief explanation of the drawings]

[0011] [Figure 1] 1 illustrates a medical device configured to perform one or more aspects of various embodiments. [Figure 2] 2 illustrates the medical device of FIG. 1 in greater detail, according to various embodiments. [Figure 3] 2 is an exploded view of the sample module adapter of FIG. 1 in accordance with various embodiments. [Figure 4] 4 illustrates a biopsy tissue sample positioned on the biopsy sample strainer of FIG. 3 in accordance with various embodiments. [Figure 5A] 4 illustrates in greater detail the sample-facing surface of the medal-shaped electrode array of FIG. 3 according to various embodiments. [Figure 5B] 4 illustrates the opposite side of the medal-shaped electrode array 320 of FIG. 3 in more detail, according to various embodiments. [Figure 6] 1A-1C are schematic illustrations of tab electrodes employed to contact a biopsy tissue sample according to various embodiments. [Figure 7] 7A-7C illustrate a biopsy tissue sample placed on the sample-facing surface of the tab electrode of FIG. 6 in accordance with various embodiments. [Figure 8] 2 illustrates the medical device of FIG. 1 arranged in parallel with a first sample module adapter and a second sample module adapter according to various embodiments. [Figure 9] 1A-1C illustrate schematic diagrams of transparent electrode arrays that may be employed to contact a biopsy tissue sample according to various embodiments. [Figure 10] 1 is a flow chart of performing a biopsy procedure on a tissue sample according to various embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0012] For clarity, the same reference numbers have been used, whenever possible, to designate identical elements common to the figures. It is contemplated that features of one embodiment may be incorporated into other embodiments without further description.

[0013] In the following description, numerous specific details are set forth to provide a more thorough understanding of various embodiments, however, the conceptual scope of the embodiments includes some embodiments that do not include one or more of these specific details.

[0014] System Overview FIG. 1 illustrates a medical device 100 configured to implement one or more aspects of various embodiments. The medical device 100 enables ex vivo, real-time biopsy evaluation of a tissue sample, such as a biopsy tissue taken from a site on a patient's body as part of a surgical biopsy procedure. Based on one or more bioimpedance biomarkers, the medical device 100 identifies the tissue type of the tissue sample, thereby providing immediate feedback to the clinician performing the surgical biopsy procedure. As described in greater detail below, the medical device 100 identifies a particular tissue sample based on the tissue sample's impedance measurements. As a result, the clinician may be informed within seconds that a particular sample contains cancerous, non-cancerous, or pre-cancerous tissue. Furthermore, this occurs with little or no interruption to the workflow of the surgical biopsy procedure. As illustrated, 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.

[0015] The sample module 120 may hold a tissue sample (not shown) and contact the tissue sample with the first electrode 121 and the second electrode 122 of the electrode array 126 to perform an impedance scan of the tissue sample. In the embodiment shown in FIG. 1 , the sample module 120 includes a tissue sample receiving surface 125 and an electrode array 126. For an impedance scan, the tissue sample is placed on the tissue sample receiving surface 125 and contacts the first electrode 121 and the second electrode 122 of the electrode array 126. Generally, the sample module 120 is included in a sample module adapter 130.

[0016] 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, a number of different configurations of sample modules 120 may be employed with the medical device 100. In such embodiments, a first sample module adapter 130 may be configured to communicatively couple the sample module 120 in a first configuration to the impedance bridge 140, a second sample module adapter 130 may be configured to communicatively couple the sample module 120 in a second configuration to the impedance bridge 140, and so on. In this manner, the medical device 100 may utilize a number of different configurations of sample modules 120. Various embodiments of the sample module 120 and sample module adapter 130 are now described with reference to Figures 2-9.

[0017] The impedance bridge 140 is an impedance load that the controller 160 measures to determine the impedance of the circuit including the impedance bridge 140, the amplifier (if present), and the electrode array 126. For example, in some embodiments, the controller 160 generates a frequency for a current to flow in the circuit including the impedance bridge 140 and the electrode array 126 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. In various embodiments, the impedance bridge 140 further includes an amplifier (not shown), which is an analog interface amplifier that amplifies the supplied and / or return voltages while the current flows between the impedance bridge 140 and the electrode array 126 at various frequencies. When a tissue sample contacts the first electrode 121 and the second electrode 122 of the electrode array 126, the sample module 120 is placed in the sample module adapter 130, and the sample module adapter 130 is coupled to the medical device 100, the impedance bridge 140 and the electrode array 126 form a circuit. The digitizing circuit 150 digitizes the signal so that the circuit can operate the control unit 160.

[0018] The controller 160 includes a processor 161 and a memory 162 and performs one or more operations to implement various embodiments described herein. For example, in some embodiments, the controller 160 executes a program stored in the memory 162 to perform multiple 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 receives instructions from a user via the I / O device 170 to perform electrical measurements, such as one or more impedance measurements 163, using the electrode array 126. In some embodiments, the controller 160 receives instructions from a user via the I / O device 170 and stores data, such as data related to the one or more impedance measurements 163. In some embodiments, the stored data related to the impedance measurements 163 includes measured electrical properties determined by a measurement circuit including the impedance bridge 140 and the electrode array 126. For example, in some embodiments, the controller 160 stores measured voltages and measured currents for an input signal at a particular operating frequency.

[0019] In some embodiments, the controller 160 identifies a tissue type 164 of the tissue sample contacting the first electrode 121 and the second electrode 122. In embodiments, the identified tissue type is based on one or more impedance measurements 163 associated with the sample contacting the first electrode 121 and the second electrode 122. In various embodiments, the controller 160 determines the identified tissue type 164 by comparing the impedance measurements 163 to one or more characteristic impedance measurements associated with the one or more tissue types. For example, but not by way of limitation, based on this comparison, the controller 160 may identify which tissue type is associated with a characteristic impedance measurement that is closest to the impedance measurement 163 of the sample tissue contacting the first electrode 121 and the second electrode 122.

[0020] In various embodiments, the controller 160 may determine the Cole relaxation frequency of the tissue sample based on the impedance measurements 163. Specifically, the controller 160 calculates the Cole relaxation frequency of the tissue sample based on the impedance corresponding to the operating frequency, where the Cole relaxation frequency of the sample tissue reflects the rate at which cell membranes release stored electrical charge. In embodiments, the controller 160 compares the Cole relaxation frequency to one or more characteristic Cole relaxation frequencies of one or more tissue types. The Cole relaxation frequency of a particular tissue sample corresponds to the frequency associated with the largest impedance measurement 163 among the one or more impedance measurements 163 of that particular tissue sample. In various embodiments, the Cole relaxation frequency is the frequency of the largest normalized impedance measurement of the tissue sample in contact with the first electrode 121 and the second electrode 122.

[0021] Due to the different electrical properties of malignant and non-malignant cells, malignant cells have a Cole relaxation frequency that is 1 / 1000 of the Cole relaxation frequency of non-malignant cells. Consequently, in some embodiments, a lower threshold frequency ( for example Based on a Cole relaxation frequency below 105 Hz (105 Hz), the controller 160 may identify the tissue sample in contact with the first electrode 121 and the second electrode 122 as a non-tumor tissue type (also referred to as non-cancerous tissue). Similarly, in some embodiments, based on a Cole relaxation frequency above an upper threshold frequency, the controller 160 may identify the tissue sample in contact with the first electrode 121 and the second electrode 122 as a tumor tissue type (also referred to as cancerous tissue). Further, for example, but not limited to, for example , which is 500 kHz) and the lower threshold frequency ( for example Based on the Cole relaxation frequency between the upper threshold frequency (which is 1 MHz, . . . 1 MHz), the controller 160 may identify the tissue sample in contact with the first electrode 121 and the second electrode 122 as pre-cancerous tissue.

[0022] In some embodiments, processing unit 161 may be a single central processing unit (CPU) or a combination of processing units. Processing unit 161 may be any technically possible hardware unit capable of processing data and / or executing software code. In some embodiments, processing unit 161 may receive instructions from a user via I / O device 170 and / or from memory 162 and execute such instructions. In some embodiments, processing unit 161 implements one or more techniques performed by control unit 160. In some embodiments, memory 162 is configured to store data and / or software applications. Memory 162 may include a random access memory (RAM) module, a hard disk, a flash memory unit, or any other type of memory unit, or a combination thereof. Control unit 160 and I / O unit 130 are configured to read data from and write data to memory 162.

[0023] The input / output (I / O) devices 170 include devices capable of receiving one or more inputs and may include a keyboard, mouse, input tablet, camera, and / or three-dimensional (3D) scanner. In some embodiments, the I / O devices 170 may also include devices capable of providing one or more outputs, such as a speaker, printer, or display 171. The display 171 displays data generated by the medical device 100. In embodiments, the display 171 displays one or more of the calculated Cole relaxation frequency and / or the identified tissue type 164. In some embodiments, the display 171 may refresh the data generated by the medical device 100 while the medical device 100 is measuring a particular tissue sample. The I / O devices 170 may also include devices capable of both receiving input and providing output, such as a touchscreen and a universal serial bus (USB) port.

[0024] FIG. 2 is a more detailed diagram 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. FIG. 2 also shows a display output 221 that includes a graphical user interface 229. In the embodiment shown in FIG. 2, the graphical user interface 229 includes, but is not limited to, patient-specific information 222 about the patient associated with the tissue sample, a graphical representation of the tissue sample scan results 223, a textual representation of the tissue sample scan results 224, and one or more interaction buttons 225 for receiving user input. In the embodiment shown in FIG. 2, the medical device 100 includes a barcode scanner 226 for entering patient information.

[0025] Embodiments of medal-shaped electrodes 3 is an exploded view of a sample module adapter 230 according to various embodiments. The sample module adapter 230 is configured to position the medal-shaped electrode array 320 so that a tissue sample (not shown) contacts the first electrode 321 and the second electrode 322 of the medal-shaped electrode array 320. The sample module adapter 230 is further configured to communicatively couple the medal-shaped electrode array 320 and the tissue sample to the impedance bridge 140 of FIG. 1. As shown, the sample module adapter 230 includes, but is not limited to, a compressed tissue sample holder 331, a medal-shaped electrode array 320, a biopsy sample strainer 332, strainer alignment features 333 for positioning the biopsy sample strainer 332, electrical contacts 333, and a housing 334.

[0026] When the compressed tissue sample holder 331 is placed in the housing 334 over the medal-shaped electrode array 320, it presses the medal-shaped electrode array 320 against a tissue sample (not shown) placed on the tissue sample receiving surface 335 of the sample module adapter 230. In the embodiment shown in FIG. 3, the tissue sample receiving surface 335 is the upper surface of the biopsy sample strainer 332, which is coupled to the strainer alignment features 333 during operation. The compressed tissue sample holder 331 includes conductive portions (not shown) that electrically couple the medal-shaped electrode array 320 to the impedance bridge 140 of FIG. 1, for example, via the electrical contacts 333. The biopsy sample strainer 332 is positioned within the medal-shaped electrode array 320 via the strainer alignment features 333. In operation, a tissue sample is forced onto the biopsy sample strainer 332 so that the first electrode 321 and the second electrode 322 contact the tissue sample when the compressed tissue sample holder 331 is coupled to the housing 334 of the medal-shaped electrode array 320. A biopsy tissue sample is shown positioned on the biopsy sample strainer 332 in FIG.

[0027] 4 illustrates, according to various embodiments, a biopsy tissue sample 401 being placed on a biopsy sample strainer 332. The biopsy tissue sample 401 may be collected using a needle biopsy syringe 402 and, after collection, placed on the biopsy sample strainer 332 as shown. The compressed tissue sample holder 331 (not shown in FIG. 4) may be removed from the housing 334 to provide access to the tissue sample receiving surface 335 of the biopsy sample strainer 332.

[0028] Returning to Figure 3, the medal-shaped electrode array 320 includes a first electrode 321 and a second electrode 322. In the embodiment shown in Figure 3, a portion of the first electrode 321 is disposed on a surface 336 of the medal-shaped electrode array 320 facing the sample (not visible in Figure 3), and a portion of the first electrode 321 is disposed on an opposite surface 337 of the medal-shaped electrode array 320. Similarly, a portion of the second electrode 322 is disposed on the surface 336 facing the sample, and a portion of the second electrode 322 is disposed on the opposite surface 337. With reference to Figures 5A and 5B, an embodiment of the medal-shaped electrode array 320 will be described in greater detail.

[0029] 5A is a plan view of a sample-facing surface 336 of a medal-shaped electrode array 320 according to various embodiments, and FIG. 5B is a plan view of an opposite surface 337 of a medal-shaped electrode array 320 according to various embodiments. As shown, a portion of a first electrode 321 is disposed on the sample-facing surface 336, and a portion (mesh pattern) of the first electrode 321 is disposed on the opposite surface 337 of the medal-shaped electrode array 320. Similarly, a portion of a second electrode 322 is disposed on the sample-facing surface 336, and a portion (mesh pattern) of the second electrode 322 is disposed on the opposite surface 337 of the medal-shaped electrode array 320. To facilitate sufficient electrical contact with a tissue sample disposed on the tissue sample-receiving surface 335 of the sample module adapter 230 (shown in FIG. 3), the portion of the first electrode 321 disposed on the sample-facing surface 336 includes multiple electrode elements, and the portion of the second electrode 322 disposed on the sample-facing surface 336 includes multiple electrode elements. In the embodiment shown in FIG. 5A, the electrode elements included in the first electrode 321 and disposed on the sample-facing surface 336 are interdigitated with the elements included in the second electrode 322 and disposed on the sample-facing surface 336.

[0030] In some embodiments, the medal-shaped electrode array 320 has a round configuration to allow the medal-shaped electrode array 320 to be arranged in any rotational orientation. Furthermore, a portion of the first electrode 321 disposed on the opposite surface 337 is radially offset from a portion of the second electrode 322 disposed on the opposite surface 337. Therefore, the medal-shaped electrode array 320 can be electrically connected to the conductor included in the compressed tissue sample holder 331 regardless of the rotational orientation of the medal-shaped electrode array 320. For example, in the embodiment shown in FIG. 5B , the portion of the first electrode 321 disposed on the opposite surface 337 is located at a central position of the opposite surface 337, and the portion of the second electrode 321 forms a ring that is radially outward from the portion of the first electrode 321 on the opposite surface 337.

[0031] Tab electrode embodiment In some embodiments, impedance measurements of the tissue sample are collected via tab electrodes. In such embodiments, tab electrodes are employed instead of medal-shaped electrodes to make electrical contact with the tissue sample. One such embodiment is described with reference to FIG. 6.

[0032] FIG. 6 schematically illustrates a tab electrode 600 that may be employed to contact a biopsy tissue sample (not shown) according to various embodiments. As illustrated, the tab electrode 600 includes a first electrode 621 and a second electrode 622. The first electrode 621 includes multiple electrode elements electrically coupled to each other via first edge electrode elements 631, and the second electrode 622 includes multiple electrode elements electrically coupled to each other via second edge electrode elements 632. Similar to the medal-shaped electrode array 320 of FIG. 3, in the embodiment illustrated in FIG. 6, the electrode elements included in the first electrode 621 are interdigitated with the electrode elements included in the second electrode 622. Unlike the medal-shaped electrode array 320, the electrode elements included in the first electrode 621 and the electrode elements included in the second electrode 622 are formed on a sample-facing surface 636. Thus, in operation, the first electrode 621 and the second electrode 622 contact a tissue sample (not shown) when the tissue sample is placed on the sample-facing surface 636. Placement of a biopsy tissue sample on the sample-facing surface 636 is shown in FIG.

[0033] FIG. 7 illustrates a biopsy tissue sample 701 being placed on the sample-facing surface 636 of the tab electrode 600, according to various embodiments. The biopsy tissue sample 701 is collected using a needle biopsy syringe 702 and, after collection, is placed on the sample-facing surface 636 as shown. FIG. 7 also illustrates the tab electrode 600 coupled to a sample module adapter 730 configured to accept the tab electrode 600, which is shown coupled to the medical device 100 in FIG. 7. In some embodiments, the medical device 100 is configured to couple to a number of different configurations of sample module adapters, such as the sample module adapter 230 of FIG. 2 and the sample module adapter 730 of FIG. 7. One such embodiment is described with reference to FIG. 8.

[0034] 8 illustrates a medical device 100 arranged in parallel 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 corresponds to the sample module adapter 230 of FIG. 2, and the second sample module adapter 832 corresponds to the sample module adapter 730 of FIG. 7. As shown, both the first sample module adapter 831 and the second sample module adapter 832 can be coupled to the medical device 100. Thus, the medical device 100 can use either medal electrodes or tab electrodes to contact a tissue sample and obtain impedance measurements.

[0035] Transparent electrode embodiment In some embodiments, impedance measurements of a tissue sample are collected via a transparent electrode array disposed on an optically transparent substrate. In such embodiments, the optically transparent substrate may be employed as a microscope slide. One such embodiment is described with reference to FIG. 9.

[0036] 9 schematically illustrates an array 920 of transparent electrodes employed by various embodiments to contact a biopsy tissue sample 901. 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 electrical connections 903 to the impedance bridge 140 of FIG.

[0037] In the embodiment of FIG. 9 , 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 titanium nitride and / or indium tin oxide. In such embodiments, the first electrode 921 and the second electrode 922 are substantially transparent to visible light, and thus the transparent substrate 902 may be employed as an optical microscope slide. Thus, impedance measurements of the biopsy tissue sample 901 may be performed when the biopsy sample 901 is disposed on the transparent substrate 902. Next, since the first electrode 921 and the second electrode 922 do not interfere with microscopic pathological evaluation of the biopsy tissue sample 901, conventional microscopic pathological evaluation of the biopsy tissue sample 901 can be performed without removing the biopsy tissue sample 901 from the transparent substrate 902.

[0038] Methods for assessing cancer tissue during surgical biopsy 10 is a flow diagram of performing a biopsy procedure on a tissue sample according to various embodiments. The method steps are described with reference to FIGS. 1-8, but one skilled in the art will recognize that any system configured to perform the method steps in any order is within the scope of the present invention.

[0039] As shown, method 1000 begins at step 1002, in which a biopsy sample is obtained from a site of a patient's body, such as a target lesion. In some instances, the lesion may be imaged to identify the location of the target lesion. For example, in some instances, the site of the patient's body may be imaged via X-ray, ultrasound, and / or magnetic resonance imaging (MRI). The biopsy sample is then taken using an appropriate biopsy procedure, which may be determined based on the location of the target lesion and / or the general area of ​​interest in the patient's body. Examples of such biopsy procedures include needle biopsy, endoscopic biopsy, skin biopsy, bone marrow biopsy, surgical biopsy, etc. Typically, a needle or hollow tube is used to obtain a particular biopsy sample from a body site or target lesion.

[0040] In step 1004, a biopsy sample is placed on the sample receiving surface 125 of the sample module 120. For example, in some instances, saline is used to force the biopsy sample, such as a biopsy core, from a needle biopsy syringe onto the tissue sample receiving surface 335 of the sample module adapter 230. Alternatively, the biopsy sample may be forced onto the sample-facing surface 636 of the tab electrode 600 or onto the transparent substrate 902.

[0041] In step 1006, the sample module 120 with the biopsy core placed therein is coupled to an appropriate sample module adapter 130, such as sample module adapter 230 or sample module adapter 730. In some embodiments, a removable compressible tissue sample holder is first used to press the electrode array of the sample module 120 against the biopsy sample placed on the tissue sample receiving surface 125 of the sample module 120.

[0042] In step 1008, one or more impedance measurements 163 of the biopsy sample are taken using the medical device 100. As previously described, the one or more impedance measurements 163 are taken and recorded at one or more frequencies via the controller 160, impedance bridge 140, and electrode array 126.

[0043] In step 1010, the controller 160 determines an identified tissue type 164 for the biopsy sample based on the impedance measurements 163 taken in step 1008. In some embodiments, the identified tissue type 164 is further determined based on a comparison of the Cole relaxation frequency of the biopsy sample to one or more characteristic Cole relaxation frequencies of one or more tissue types. In such embodiments, such comparison may be based on a single threshold frequency, or a lower threshold frequency and an upper threshold frequency.

[0044] In embodiments where the comparison is based on a single threshold frequency, if the Cole relaxation frequency of the biopsy sample is below the single threshold frequency, the controller 160 determines that the identified tissue type 164 is non-cancerous; if the Cole relaxation frequency of the biopsy sample is above the single threshold frequency, the controller 160 determines that the identified tissue type 164 is cancerous. Alternatively, in embodiments where the comparison is based on lower and upper threshold frequencies, if the Cole relaxation frequency of the biopsy sample is below the lower threshold frequency, the controller determines that the identified tissue type 164 is non-cancerous; if the Cole relaxation frequency of the biopsy sample is above the upper threshold frequency, the controller determines that the identified tissue type 164 is cancerous; and if the Cole relaxation frequency of the biopsy sample is above the lower threshold frequency and below the upper threshold frequency, the controller determines that the identified tissue type 164 is pre-cancerous. The threshold frequency generally varies depending on the particular tissue type and may be empirically determined. For example, the threshold frequency for pancreatic tissue may be significantly different from the threshold frequencies for spinal cord tissue, skin tissue, lung tissue, etc.

[0045] In step 1012, controller 160 causes one or more indicators of the identified tissue type 164 to be displayed. For example, in some embodiments, controller 160 causes display 171 to display a graphical representation 223 of the results for the biopsy sample. Alternatively, or additionally, in some embodiments, controller 160 causes display 171 to display a textual representation 224 of the results for the biopsy sample.

[0046] In summary, the embodiments described herein enable tissue type identification for a tissue sample. Based on in vitro impedance measurements made on the tissue sample, the medical device can determine whether the tissue sample is cancerous, non-cancerous, or pre-cancerous. An impedance bridge is employed to make the impedance measurements without altering or depleting the tissue sample, and further, the electrode array of the medical device is configured with interdigitated electrode elements to facilitate electrical contact with the tissue sample during such measurements.

[0047] At least one technical advantage of the disclosed designs and techniques over conventional approaches is that they provide immediate, real-time feedback to the clinician performing the surgical biopsy. As a result, if a tissue sample is determined to be non-diagnostic via the disclosed designs and techniques, the clinician may immediately collect one or more additional tissue samples, thereby avoiding the long delay in diagnosing non-diagnostic tissue samples that is typical of conventional approaches. Furthermore, because the disclosed designs and techniques provide feedback to the physician within seconds, the workflow of the surgical biopsy procedure is not substantially affected and the length of the surgical biopsy procedure is not significantly extended. A further technical advantage of the disclosed techniques is that they do not alter the tissue sample collected by the clinician, thereby not adversely affecting the reliability of subsequent pathology testing. These technical advantages provide one or more technical advantages over conventional approaches.

[0048] 1. In an embodiment, 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.

[0049] 2. The medical device described in paragraph 1, wherein the first electrode includes a first plurality of electrode elements and the second electrode includes a second plurality of electrode elements.

[0050] 3. The medical device of paragraph 1 or 2, wherein the electrode elements of the first plurality of electrode elements are interdigitated with the electrode elements of the second plurality of electrode elements.

[0051] 4. The medical device according to any one of paragraphs 1 to 3, wherein the tissue sample receiving surface is disposed on an optically transparent substrate.

[0052] 5. A medical device described in any one of paragraphs 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.

[0053] 6. The medical device of any one of paragraphs 1 to 5, wherein the first electrode and the second electrode are transparent to visible light.

[0054] 7. The medical device of any one of paragraphs 1 to 6, wherein the electrode array is disposed on the tissue sample receiving surface.

[0055] 8. The medical device of any one of paragraphs 1 to 7, further comprising a removable compressible tissue sample holder that presses the electrode array against a tissue sample disposed on the tissue sample receiving surface.

[0056] 9. The medical device of any one of paragraphs 1 to 8, wherein the removable compressed tissue sample holder includes one or more conductive portions communicatively coupled to the impedance bridge and the electrode array.

[0057] 10. The medical device of any one of paragraphs 1 to 9, further comprising an adapter opening for selectively receiving a first sample module adapter for accommodating a tissue sample or a second sample module adapter for accommodating a tissue sample.

[0058] 11. The medical device of any one of paragraphs 1 to 10, wherein the first sample module adapter includes a tissue sample receiving surface and a removable compressible tissue sample holder that presses the electrode array against a tissue sample placed on the tissue sample receiving surface.

[0059] 12. The medical device of any one of paragraphs 1 to 11, wherein the second sample module adapter includes a tissue sample receiving surface and an electrode array disposed on the tissue sample receiving surface.

[0060] 13. A medical device described in any one of paragraphs 1 to 12, further comprising a control unit that, during operation, performs the steps of 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 a tissue sample, identifying a tissue type of the tissue sample based on the one or more impedance measurements, and displaying an indication of the tissue type.

[0061] 14. A medical device described in any one of paragraphs 1 to 13, wherein the step of identifying the tissue type includes a step of comparing one or more impedance measurements with one or more characteristic impedance measurements associated with one or more tissue types.

[0062] 15. In some embodiments, a method for analyzing a tissue sample includes recording one or more impedance measurements at one or more frequencies associated with an electrode array included in a medical device, the electrode array including a first electrode contacting the tissue sample while positioned on a tissue sample receiving surface and a second electrode contacting the tissue sample; identifying a tissue type of the tissue sample based on the one or more impedance measurements; and displaying an indicator of the tissue type.

[0063] 16. The method of paragraph 15, wherein the tissue type is selected from the group consisting of cancerous tissue, non-cancerous tissue, and pre-cancerous tissue.

[0064] 17. The method of claim 15 or 16, wherein identifying the tissue type comprises comparing the one or more impedance measurements to one or more characteristic impedance measurements associated with one or more tissue types.

[0065] 18. The method of any one of paragraphs 15 to 17, wherein identifying the tissue type includes identifying a Cole relaxation frequency of a portion of the tissue based on one or more impedance measurements, and comparing the Cole relaxation frequency of the portion of the tissue to one or more characteristic Cole relaxation frequencies of one or more tissue types.

[0066] 19. The method of any one of paragraphs 15 to 18, wherein the Cole relaxation frequency corresponds to the frequency associated with the largest impedance measurement included in the one or more impedance measurements.

[0067] 20. The method of any one of paragraphs 15 to 19, wherein the marking is displayed on a display device associated with the medical device.

[0068] Any and all combinations of any claim element recited in any claim and / or any element described herein, in any manner, are within the contemplated scope and protection of the present invention.

[0069] The descriptions of various embodiments are provided for purposes of illustration and are not intended to be exhaustive or to limit the present disclosure to embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments.

[0070] Aspects of the present disclosure may be embodied as a system, a method, or a computer program product. Accordingly, aspects of the present disclosure may be entirely hardware embodiments, entirely software embodiments (including firmware, resident software, microcode, etc.), or embodiments combining software and hardware aspects, which may be generally referred to herein as a "module," "system," or "computer." Furthermore, any hardware and / or software techniques, processes, functions, components, engines, modules, or systems of the present disclosure may be embodied as a circuit or set of circuits. Furthermore, aspects of the present disclosure may take the form of a computer program product stored on one or more computer-readable medium(s) having computer-readable program code embodied therein.

[0071] Any combination of one or more computer-readable media may be used. The computer-readable medium may be a computer-readable signal medium or a computer-readable storage medium. The computer-readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination thereof. More specific examples of computer-readable storage media (a non-exhaustive list) may include: an electrical connection having one or more wires, a portable computer disk, 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 disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination thereof. In the context of this specification, a computer-readable storage medium may be any tangible medium that contains or stores a program for use by or in connection with an instruction execution system, apparatus, or device.

[0072] Aspects of the present disclosure have been described above with reference to flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present disclosure. It will 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, a special-purpose computer, or other programmable data processing apparatus to produce a machine. The instructions, when executed by a processor of the computer or other programmable data processing apparatus, cause the processor to perform the function(s) / act(s) specified in the block or blocks of the flowcharts and / or block diagrams. Such a processor may be, but is not limited to, a general-purpose processor, a special-purpose processor, an application-specific processor, or a field-programmable gate array.

[0073] The flowcharts and block diagrams in the figures illustrate possible architectures, functions, and operations of systems, methods, and computer program products according to various embodiments of the present disclosure. In this regard, each block in the flowcharts or block diagrams represents a module, segment, or portion of code, which comprises one or more executable instructions for implementing a particular logical function. It should also be noted that in some alternative embodiments, the functions in the block diagrams may occur out of the order shown in the figures. For example, two blocks shown in succession may in fact be executed substantially concurrently, depending on the functionality involved, or in some cases the blocks may be executed in the reverse order. 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, may be implemented by a special-purpose hardware-based system that performs a particular function or operation or combination of special-purpose hardware and computer instructions.

[0074] While the foregoing describes embodiments of the present disclosure, other and further embodiments of the present disclosure are contemplated without departing from the basic scope thereof, the scope of which is determined by the following claims. [Explanation of symbols]

[0075] 100 Medical Devices 120 Sample Module 126 Electrode Array 130, 230, 730, 831, 832 Sample Module Adapter 140 Impedance Bridge 320 Medal-shaped electrode array 335 Tissue sample receiving surface 600 Tab electrode

Claims

1. In medical devices, 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; an impedance bridge communicatively coupled to the electrode array; 2. A medical device comprising:

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

3. The medical device of claim 2 , wherein the electrode elements of the first plurality of electrode elements are interdigitated with the electrode elements of the second plurality of electrode elements.

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

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

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

8. a removable compressible tissue sample holder for pressing the electrode array against the tissue sample disposed on the tissue sample receiving surface; The medical device of claim 1 further comprising:

9. 9. The medical device of claim 8, wherein the removable compressed tissue sample holder includes one or more conductive portions communicatively coupled to the impedance bridge and the electrode array.

10. an adapter opening for selectively receiving a first sample module adapter for receiving the tissue sample or a second sample module adapter for receiving the tissue sample; The medical device of claim 1 further comprising:

11. 11. The medical device of claim 10, wherein the first sample module adapter includes a removable compressible tissue sample holder that presses the electrode array against the tissue sample placed on the tissue sample receiving surface.

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

13. The control unit and wherein the control unit, during operation, 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; identifying a tissue type of the tissue sample based on the one or more impedance measurements; displaying the tissue type indicator; The medical device according to claim 1 ,

14. 14. The medical device of claim 13, wherein identifying the tissue type comprises comparing the one or more impedance measurements to one or more characteristic impedance measurements associated with one or more tissue types.

15. 1. A method for analyzing a tissue sample, comprising: recording, at one or more frequencies, one or more impedance measurements associated with an electrode array included in the medical device, the electrode array including a first electrode in contact with the tissue sample while disposed on the tissue sample receiving surface and a second electrode in contact with the tissue sample; identifying a tissue type of the tissue sample based on the one or more impedance measurements; displaying the tissue type indicator; A method comprising:

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

17. 16. The method of claim 15, wherein identifying the tissue type comprises comparing the one or more impedance measurements to one or more characteristic impedance measurements associated with one or more tissue types.

18. The step of identifying the tissue type includes: identifying a Cole relaxation frequency of a portion of tissue based on the one or more impedance measurements; comparing the Cole relaxation frequency of the portion of tissue to one or more characteristic Cole relaxation frequencies of one or more tissue types; 16. The method of claim 15, comprising:

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

20. The method of claim 15 , wherein the indicia is displayed on a display device associated with the medical device.

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