Technical method for controlling a medical device tool

Abstract

In various embodiments, the medical device includes a device lead having one or more electrode pairs and a medical device tool connected to a conduit, an impedance bridge, and a processor connected to the impedance bridge and the conduit. In various embodiments, the method includes recording one or more impedance measurements associated with one or more electrode pairs on the device lead of the medical device at one or more frequencies, determining a tissue type of a portion of tissue in contact with the one or more electrode pairs based on the one or more impedance measurements, and controlling the medical device tool on the device lead by performing one or more operations based on the tissue type.

Description

Cross - reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 142,242, filed on January 27, 2021; U.S. Provisional Patent Application No. 63 / 142,247, filed on January 27, 2021; U.S. Provisional Patent Application No. 63 / 142,254, filed on January 27, 2021; U.S. Provisional Patent Application No. 63 / 142,260, filed on January 27, 2021; and U.S. Patent Application No. 17 / 412,973, filed on August 26, 2021. The subject matter of these related applications is hereby incorporated by reference in their entirety into this application.

Technical Field

[0002] Various embodiments of the present disclosure generally relate to electronics and medical diagnostic technologies, and more specifically, relate to various technical methods for controlling medical device tools.

Background Art

[0003] In minimally invasive medical procedures, medical practitioners typically insert a medical device into a patient's body and then position the distal end of the medical device at a target site such as a tumor site. The distal end of the device is usually provided with some form of tool, including but not limited to, a therapeutic agent delivery tool for delivering a therapeutic agent to the target site, an energy delivery tool for delivering energy (e.g., heat or electricity) to the target site, a tissue sample extraction tool that can be used to extract a tissue sample from the target site for future evaluation, or various combinations thereof.

[0004] One problem that exists in many conventional medical devices is that operating the medical device tool at a location inside the patient's body that is different from the desired target site can damage the tissue of a patient who would otherwise be healthy, resulting in the target site not being properly treated, or both. Therefore, by providing various mechanisms in conventional medical devices, it is often the case that the location of the relevant medical device tool inside the patient's body is determined. Specific mechanisms include, but are not limited to, transceivers that transmit signals that can be used for triangulation and ultrasonic visible substances that can be visualized by ultrasonic imaging.

[0005] One drawback of the above mechanisms used for the purpose of determining the location of a medical device tool relative to a patient's body is that these mechanisms are often inaccurate and thus insufficient to confirm that a given tool is correctly positioned at a given target site. More specifically, in triangulation and ultrasonic imaging, it is usually necessary to calibrate the relevant positioning system with respect to both the medical device tool and the mapping of the patient's body generated using, for example, a medical scan. Various errors introduced during the calibration process can result in errors when determining whether the medical device tool is correctly positioned at the target site. Also, any physiological changes inside the patient's body between the time the medical scan was performed and the time the medical treatment procedure was initiated, such as any changes in the dimensions, shape, location, etc. of a tumor, can change the target site. Thus, when positioning a medical device tool based on a medical scan, there is a possibility that the medical device tool will be directed at healthy tissue instead of the target site. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0006] As illustrated up to the previous paragraph, what is needed in the art is a more effective technical method for controlling medical device tools. MEANS FOR SOLVING THE PROBLEMS

[0007] Various embodiments of a medical device will be disclosed. In various embodiments, the medical device includes a device head portion including one or more electrode pairs and a medical device tool connected to a catheter, an impedance bridge, a processor connected to the impedance bridge and the catheter, and the like.

[0008] Various embodiments of controlling a medical device will be disclosed. In various embodiments, the method of the present application includes a step of recording one or more impedance measurement values associated with one or more electrode pairs provided in a device head portion of a medical device at one or more frequencies, a step of determining a tissue type of a part of the tissue in contact with the one or more electrode pairs based on the one or more impedance measurement values, and a step of controlling a medical device tool provided in the device head portion based on the tissue type by performing one or more operations.

Advantages of the Invention

[0009] At least one technical advantage of the medical device disclosed herein compared to the prior art is that the medical device disclosed herein confirms that the medical device tool is disposed at a given target site before operating the medical device tool. For example, before operating the medical device at the target site, the medical device disclosed herein can also determine that the tissue type of a part of the tissue in contact with each electrode of the device head portion of the medical device matches the expected tissue type. In this way, the medical device disclosed herein can be more accurately applied to the tissues of various target sites than conventional medical devices when applying various medical device tools. As a result, the medical device disclosed herein can be used not only for delivering therapeutic agents or energy or extracting tissue samples, but also for performing various treatment procedures more accurately and reliably at a specific target site compared to what can be achieved with conventional medical devices. These technical advantages bring one or more technical improvements over the approaches of the prior art.

Brief Description of the Drawings

[0010]

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DETAILED DESCRIPTION OF THE INVENTION

[0011] In the following description, for the purpose of providing a more complete understanding of the various embodiments, numerous specific details will be set forth. However, in the scope of the embodiments of each concept, there are some embodiments that omit one or more of these specific details.

[0012] FIG. 1 illustrates a medical device 100 according to various embodiments. As shown, the medical device 100 includes, but is not limited to, a device head 108, a wire 104, an external electrical component 106, etc. The device head 108 is disposed at a target site 102 (e.g., a tumor site). Although not shown, the device head 108 includes one or more pairs of electrodes, a catheter, a medical device tool, etc., and specific examples of the tool include a therapeutic agent delivery tool for delivering a therapeutic agent to the target site 102, an energy delivery tool for delivering energy to the target site 102, a tissue sample extraction tool for extracting a tissue sample from the target site 102 for future evaluation, etc., but are not limited thereto. The external electrical component 106 generates electrical currents of various frequencies. The wire 104 conducts an electrical current between the external electrical component 106 and the device head 108. The external electrical component 106 includes a processor that measures the impedance of one or more pairs of electrodes of the device head 108 and the impedance of a portion of the tissue of the target site 102 in contact with the one or more pairs of electrodes. As will be described in more detail below, the medical device 100 determines the tissue type of the portion of the tissue in contact with the one or more pairs of electrodes based on the impedance measurement value. By way of non-limiting example, based on the impedance measurement value, it can be determined that the tissue type of the portion of the tissue is one of a tumor tissue type or a non-tumor tissue type.

[0013] FIG. 2 is a diagram that more particularly illustrates the device head 108 of FIG. 1 according to various embodiments. As shown, the device head 108 includes, but is not limited to, electrode pairs 202, medical device tools 204, catheters 206, wires 104, etc. The electrode pairs 202 conduct current at various frequencies into a portion of the tissue of the target site 102 that is in contact with the electrode pairs 202. The wire 104 conducts current between the external electrical component 106 and the electrode pairs 202 through the catheter 206. Although not shown in FIG. 2, the medical device includes a conduit connected to the medical device tool 204, as will be described in more detail below. In various embodiments, the medical device tool 204 delivers a therapeutic agent or energy (e.g., carried by a cannula or wire within the catheter 206), extracts a tissue sample from a portion of the tissue of the target site 102 in preparation for future evaluation, or both. With each component of the device head 108, a healthcare provider can deliver a therapeutic agent or energy to the portion of the tissue in contact with the electrode pairs 202, extract a tissue sample from the target site 102 in preparation for future evaluation, or both.

[0014] FIG. 3 is a diagram that more detailedly illustrates the device head 108 of FIG. 2 according to various embodiments. As shown, the device head 108 is composed of, but not limited to, a first electrode pair 202-1, a second electrode pair 202-2, a medical device tool 204, a catheter 302, etc. As shown, the device head 108 includes two sets of electrode pairs, 202-1 and 202-2. However, the term "electrode pair 202" as used herein should be interpreted to include various embodiments in which any number of electrode pairs 202 are provided, including one set of electrode pairs 202, three or more sets of electrode pairs 202, etc., without limitation. In various embodiments, the medical device tool 204 is a therapeutic agent delivery tool for delivering a therapeutic agent, and the catheter 302 is composed of one or more therapeutic agent delivery catheters, and each of the one or more catheters delivers one or more types of therapeutic agents to the therapeutic agent delivery tool. In various embodiments, the medical device tool 204 is an energy delivery tool such as, but not limited to, a cautery device, and the catheter 302 includes one or more wires that connect the energy delivery tool to an energy source. In various embodiments, the medical device tool 204 is a tissue sample extraction tool, and the catheter 302 includes one or more wires that connect the tissue sample extraction tool to an actuator. In various embodiments, the device head 108 includes any number of medical device tools 204, such as two or more medical device tools 204 of the same type or different types, and is not limited thereto. Further, in various embodiments, the device head 108 includes any number of catheters 302, such as two or more catheters, and is not limited thereto. In various embodiments, each catheter 302 is connected to one or more medical device tools 204, and each medical device tool 204 is connected to one or more catheters 302, or both may be satisfied.

[0015] Figures 4A and 4B are diagrams that illustrate in detail the electrode pair 202 of FIG. 2 in a first configuration according to various embodiments. As shown, the device head 108 is composed of, but not limited to, a first electrode pair 202-1, a second electrode pair 202-2, a medical device tool 204, etc. As shown, the electrode pairs 202-1 and 202-2 extend in a direction substantially parallel to the axis of the medical device tool. Also as shown, the medical device tool 204 is located between the electrodes of the electrode pair 202-1 and the electrode pair 202-2 when viewed in the direction of the axis of the medical device tool 204.

[0016] As shown in FIG. 4A, the medical device tool 204 is in a retracted position, in which the tips of the electrodes of the electrode pair 202-1 and the electrode pair 202-2 protrude axially distally beyond the tip of the medical device tool 204. Without limitation, by way of example, the medical device tool 204 may be in this retracted position until the processor determines the tissue type of the portion of the tissue in contact with the electrode pair 202-1 and the electrode pair 202-2 during deployment.

[0017] As shown in FIG. 4B, the medical device tool 204 has extended from the retracted position to an extended position, in which the tip of the medical device tool 204 protrudes axially at least as far distally as the tips of the electrodes of the electrode pair 202-1 and the electrode pair 202-2. Without limitation, by way of example, based on the determination of the tissue type of the portion of the tissue in contact with the electrode pair 202-1 and the electrode pair 202-2, the processor can cause the medical device tool 204 to extend from the retracted position to the extended position (for example, by connecting to the medical device tool 204 and activating an actuator that causes the medical device tool 204 to extend from the retracted position to the extended position).

[0018] Figures 5A and 5B are diagrams that illustrate in detail the electrode pair 202 of FIG. 2 in a second configuration according to various embodiments. As shown, the device head 108 is composed of, but not limited to, a first electrode pair 202-1, a second electrode pair 202-2, a medical device tool 204, etc. Also, as shown, the medical device tool 204 is located between the electrodes of the first electrode pair 202-1 and the second electrode pair 202-2 when viewed in the direction of the axis of the medical device tool 204.

[0019] As shown in FIG. 5A, the medical device tool 204 is in a retracted position, in which the tips of the electrodes of the electrode pair 202-1 and the electrode pair 202-2 protrude distally in the axial direction beyond the tip of the medical device tool 204. By way of non-limiting example, the medical device tool 204 may be in the retracted position until the processor determines the tissue type of the portion of the tissue in contact with the electrode pair 202-1 and the electrode pair 202-2 during deployment.

[0020] As shown in FIG. 5B, the medical device tool 204 has extended from the retracted position to an extended position, in which the tip of the medical device tool 204 protrudes distally at least to the same extent as the tips of the electrodes of the electrode pair 202-1 and the electrode pair 202-2 in the axial direction. By way of non-limiting example, based on the determination of the tissue type of the portion of the tissue in contact with the electrode pair 202-1 and the electrode pair 202-2, the processor can cause the medical device tool 204 to protrude from the retracted position to the extended position (e.g., by actuating an actuator connected to the medical device tool 204).

[0021] Although not shown, in various embodiments, each electrode pair 202 can be extended or retracted in a manner corresponding to the medical device tool 204 in the first configuration illustrated in FIGS. 4A and 4B or the second configuration illustrated in FIGS. 5A and 5B. In various embodiments, one or more sets of electrode pairs 202 can be in an extended position, where the tip of each electrode of each set of electrode pairs 202 projects distally beyond the tip of the medical device tool 204 in the axial direction of the medical device tool 204. In various embodiments, the electrode pair 202 is in this extended position until the processor determines the tissue type of the portion of the tissue in contact with the electrode pair 202 during deployment. In various embodiments, based on the determined tissue type of the result, the electrode pair 202 retracts from the extended position to the retracted position, where the tip of the medical device tool 204 projects distally at least as far as the tip of the electrode pair 202 in the axial direction. By way of non-limiting example, based on the opposite of the tissue type of the portion of the tissue in contact with the electrode pair 202, the processor can retract one or more sets of electrode pairs from the extended position to the retracted position (e.g., by actuating an actuator connected to one or more sets of electrode pairs 202). As shown, each electrode of each of the electrode pairs 202-1 and 202-2 is in a curved state so as to project laterally outward in the left-right direction with respect to the axis of the medical device tool 204. In various embodiments, at least one of each electrode of one or more sets of electrode pairs 202-1 and each electrode of electrode pair 202-2 is made of a flexible material. In various embodiments, the processor can project the medical device tool 204 from the retracted position to the extended position and can also retract the electrode pair 202 from the extended position to the retracted position. By way of non-limiting example, based on the determination of the tissue type of the portion of the tissue, the processor can project the medical device tool 204 by actuating the actuator and can also retract the electrode pair 202 by actuating the actuator.

[0022] As a technical advantage of these various embodiments, in various embodiments, and not limited to the following, until it is confirmed that the medical device 100 is disposed at the target site 102, the medical device tool 204 is in the retracted position, and then by protruding it, it is possible to prevent the medical device tool 204 from contacting other tissues of the patient. Similarly, until it is confirmed that the medical device 100 is disposed at the target site 102, the electrode pair 202 is in the extended position, and then by retracting it, it is possible to prevent the medical device tool 204 from contacting other tissues of the patient. Alternatively, or in addition to this, in various embodiments, and not limited to the following, by retracting the electrode pair 202, protruding the medical device tool 204, or performing both, it is possible to prevent the impedance measurement value of the relevant part of the tissue at the target site of the medical device tool 204 from being changed due to the electrode pair 202. Alternatively, or in addition to this, in various embodiments, and not limited to the following, by retracting the electrode pair 202, protruding the medical device tool 204, or performing both, during the continuation of various operations (for example, while the medical device tool 204 is delivering a therapeutic agent, delivering energy, extracting a tissue sample, or during other operations), it is possible to prevent the medical device tool 204 from contacting the electrode pair 202. Further, in various embodiments where each electrode protrudes laterally outward to the left and right with respect to the axis of the medical device tool 204, by protruding the electrode pair 202, it is possible to increase the portion where each electrode contacts the tissue (for example, impedance measurement of a large tumor can be performed), while by retracting the electrode pair 202, it is possible to reduce the portion where each electrode contacts the tissue (for example, impedance measurement of a small tumor can be performed).

[0023] FIG. 6 is a diagram illustrating the external electrical component of FIG. 1 in more detail according to various embodiments. As shown, the external electrical component 106 is composed of a wire 104, an amplifier 602, an impedance bridge 604, a processor 606, etc. The wire 104 conducts current at various frequencies between the electrode pair 202 and the external electrical component 106. In various embodiments, the amplifier 602 is an analog interface amplifier that amplifies a supply voltage, a feedback voltage, or both, while the wire 104 conducts current at various frequencies between the impedance bridge 604 and the electrode pair 202. In various embodiments, the impedance bridge 604 is an impedance load, and by measuring this by the processor 606, the impedance of a circuit composed of the impedance bridge 604, the amplifier 602, the electrode pair 202, etc. is determined. The processor 606 generates the frequency of the current conducted by the wire 104 between the impedance bridge 604 and the electrode.

[0024] While wire 104 conducts current at various frequencies, processor 606 records one or more impedance measurements 608 of the circuit including electrode pair 202. Based on these impedance measurements 608, processor 606 determines the tissue type 610 of a portion of the tissue in contact with electrode pair 202. In various embodiments, processor 606 determines tissue type 610 by comparing these impedance measurements 608 with one or more characteristic impedance measurements associated with one or more tissue types. By way of non-limiting example, based on this comparison, processor 606 can determine which tissue type is associated with the characteristic impedance measurement closest to the impedance measurement of the portion of the tissue in contact with electrode pair 202. In various embodiments, processor 606 can determine the relaxation frequency of the calls of the portion of the tissue based on impedance measurements 608, and can compare these relaxation frequencies of the calls with one or more tissue types. The relaxation frequency of the calls corresponds to the frequency associated with the maximum impedance measurement 608 included in one or more impedance measurements 608. In various embodiments, the relaxation frequency of the calls is the frequency of the maximum of the normalized impedance measurements of the portion of the tissue in contact with electrode pair 202. By way of non-limiting example, based on a relaxation frequency of the calls below a threshold frequency (e.g., 10 5 Hz (10 to the fifth power hertz)), processor 606 may determine that the portion of the tissue in contact with electrode pair 202 is a non-tumor tissue type. Similarly, by way of non-limiting example, based on a relaxation frequency of the calls above the threshold frequency, processor 606 may determine that the portion of the tissue in contact with electrode pair 202 is a tumor tissue type.

[0025] In various embodiments, the processor 606 controls the medical device tool 204 by performing one or more operations 612 based on the tissue type 610 of the determination result. By way of non-limiting example, in various embodiments where the medical device tool 204 is a therapeutic agent delivery tool, the processor 606 can perform operations 612 including, for example, operating the therapeutic agent delivery tool to deliver one or more therapeutic agents to the portion of the tissue. By way of non-limiting example, in various embodiments where the medical device tool 204 is an energy delivery tool, the processor 606 can perform operations 612 including, for example, operating the energy delivery tool to deliver energy to the portion of the tissue. By way of non-limiting example, in various embodiments where the medical device tool 204 is a tissue sample extraction tool, the processor 606 can perform various operations 612 including, for example, operating the tissue sample extraction tool to extract a tissue sample from the portion of the tissue. By way of non-limiting example, in various embodiments in which the medical device tool 204 can be protruded, the processor 606 can perform various operations 612 including, for example, protruding the medical device tool 204 from the retracted position to the extended position (by operating an actuator connected to the medical device tool 204). By way of non-limiting example, in various embodiments in which the electrode pair 202 can be retracted, the processor 606 can perform operations 612 including, for example, retracting the electrode pair 202 from the extended position to the retracted position (by operating an actuator connected to the electrode pair 202).

[0026] In various embodiments, based on the determination of the tissue type 610, the processor 606 presents a display of the tissue type 610 of the portion of the tissue in contact with the electrode pair 202. By way of non-limiting example, in presenting the tissue type 610, the processor 606 may utilize visual output (e.g., a light-emitting diode, a liquid crystal display device, etc.), audio output (e.g., a speaker, a buzzer, etc.), or both. In various embodiments, based on the determination of the tissue type 610, the processor 606 can present a display indicating that the determined tissue type 610 of the result matches the tissue type of the tissue at the target site 102. By way of non-limiting example, if the target site 102 is a tumor, the processor 606 may display that the tissue type determined to be a tumor matches the tissue type of the tissue at the target site 102. By presenting this display, the user of the medical device 100 can be informed that the leading end of the device is at the target site 102. Further, in various embodiments, when controlling the medical device tool 204 by performing one or more operations 612, the processor 606 presents a display indicating that the determined tissue type 610 of the result matches the tissue type of the tissue at the target site 102 and is based on receiving a signal for starting the medical device tool 204.

[0027] FIG. 7 is a diagram illustrating the medical device 100 of FIG. 1 in more detail according to various embodiments. As shown, the medical device 100 includes a device head portion 108, an external electrical component 106, and the like. As shown, the device head portion 108 includes an electrode pair 202 connected to the external electrical component 106 by a wire 104. In various embodiments, the device head portion 108 includes, but is not limited to, two or more electrode pairs 202, and these electrode pairs may be connected to the external electrical component 106 by one wire 104 or by each wire of a plurality of wires 104. As shown, the device head portion 108 also includes a medical device tool 204, which includes, but is not limited to, a therapeutic agent delivery tool, an energy delivery tool, a tissue sample extraction tool, and the like. In various embodiments, the device head portion 10 includes, but is not limited to, two or more medical device tools 204, and these may be of the same type or different types.

[0028] As shown, the external electrical component 106 is composed of an amplifier 602, an impedance bridge 604, a processor 606, etc. The amplifier 602 amplifies the supply voltage, the feedback voltage, or both, while the wire 104 conducts current between the impedance bridge 604 and the electrode pair 202 at various frequencies. The impedance bridge 604 is an impedance load, and by measuring this, the processor 606 determines the impedance of the circuit including the impedance bridge 604, the amplifier 602, the wire 104, the electrode pair 202, etc. The processor 606 records one or more impedance measurement values 608 at various frequencies. The processor 606 determines the tissue type 610 of a part of the tissue in contact with the electrode pair 202 based on the impedance measurement values 608. In various embodiments, the processor 606 determines the tissue type based on, but is not limited to, the relaxation frequency of a call of a part of the tissue in contact with the electrode pair 202. In various embodiments, the processor 606 determines the tissue type 610 of the part of the tissue as one of, but is not limited to, a tumor tissue type or a non-tumor tissue type. In various embodiments, the processor 606 determines that the tissue type 610 matches the tissue type of the tissue at the target site 102, which indicates or supports that the device head 108 is disposed at the target site 102, but is not limited to this. By way of non-limiting example, if the target site 102 is a tumor, the processor 606 can determine whether the device head 108 is disposed at the target site 102 by determining that the tissue type 610 is a tumor tissue type.

[0029] As shown, the processor 606 is connected to the conduit 302 of the medical device tool 204. Based on the tissue type 610 of the determination result, the processor 606 controls the medical device tool 204 by performing one or more operations 612. In various embodiments, the medical device tool 204 is a therapeutic agent delivery tool, and the processor 606 performs the operation 612 of causing one or more therapeutic agents to be delivered to the tissue at the target site 102 by the medical device tool 204, but is not limited thereto. By way of non-limiting example, the processor 606 can deliver one or more therapeutic agents through one or more drug delivery conduits to the therapeutic agent delivery tool and pass them therethrough. In various embodiments, the medical device tool 204 is an energy delivery tool, and the processor 606 performs the operation 612 of causing energy to be delivered to the tissue at the target site 102 by the conduit 302 and the medical device tool 204, but is not limited thereto. By way of non-limiting example, the processor 606 can deliver an electric current through each wire in the conduit 302 to the energy delivery tool and guide it to flow therethrough. In various embodiments, the medical device tool 204 is a tissue sample extraction tool, and the processor 606 performs the operation 612 of causing the tissue sample extraction tool to extract a tissue sample from the tissue at the target site 102, but is not limited thereto. By way of non-limiting example, the external electrical component 106 may include an actuator connected to the tissue sample extraction tool by a wire in the conduit 302, but it may be preferable that the processor 606 operates the actuator to cause the tissue sample extraction tool to extract a tissue sample.

[0030] In various embodiments, the medical device 100 notifies the user of the medical device 100 of the tissue type 610 of the determination result. By way of non-limiting example, when the medical device 100 displays an indicator of the tissue type 610 of the determination result, it may utilize visual output (e.g., a liquid crystal display (LCD), a light emitting diode (LED) display device, etc. for presenting a visual display of the tissue type 610 such as light, symbols, text, images, etc.), or when providing an audio display of the tissue type 610 of the determination result, it may utilize audio output (e.g., a speaker, a buzzer, etc. for presenting an audio cue of the tissue type 610 such as a verbal explanation, an acoustic effect, etc.), or both. In various embodiments, the processor 606 can present (e.g., utilizing visual output, audio output, etc.) an indication that the tissue type 610 of the determination result matches the tissue type of the tissue at the target site 102, but is not limited thereto.

[0031] FIG. 8 is a flowchart of each step of a method for controlling the medical device 100 of FIG. 1 according to various embodiments. Each step of the method of the present application will be described in association with each system of FIGS. 1 to 7, but those skilled in the art will understand that any system falls within the scope of the present invention if each step of the method of the present application is configured to be executed in any order.

[0032] As shown in the figure, the method 800 of the present application begins at step 802, where the processor 606 records one or more impedance measurement values 608 associated with one or more electrode pairs 202 provided at the device head 108 of the medical device 100 at one or more frequencies. In various embodiments, the processor 606 determines, for example, but not limited thereto, the relaxation frequency of a portion of the tissue in contact with one or more electrode pairs 202 of the device head 108 as the frequency of the largest of the normalized impedance measurement values of the portion of the tissue in contact with the electrode pairs 202.

[0033] In operation 804, based on one or more impedance measurement values 608, processor 606 determines a tissue type 610 of a portion of the tissue in contact with one or more electrode pairs 202. In various embodiments, processor 606 determines that the tissue type is any one of, but not limited to, a tumor tissue type or a non-tumor tissue type. In various embodiments, processor 606 determines whether the tissue type of the said portion of the tissue matches the tissue type of the tissue at the target site 102, but is not limited thereto. In various embodiments, when determining the tissue type 610, processor 606 determines by comparing the impedance measurement value 608 with one or more characteristic impedance measurement values associated with one or more tissue types. In various embodiments, processor 606 determines whether the determined tissue type 610 of the result matches the tissue type of the tissue at the target site 102 (for example, for the purpose of determining whether the leading part 108 of the device is arranged at the target site 102), but is not limited thereto.

[0034] In operation 806, processor 606 controls the medical device tool 204 provided at the leading part 108 of the device by performing one or more operations 612 based on the tissue type 610. Without being limited to specific examples, based on the determined tissue type 610 of the result, processor 606 may perform an operation 612 of causing a therapeutic agent to be delivered to the tissue at the target site 102 by the medical device tool, or may perform an operation 612 of causing energy to be delivered to the tissue at the target site 102 by the energy device tool, or may perform an operation 612 of causing a tissue sample to be extracted from the tissue at the target site 102 by the tissue sample extraction tool, or may perform an operation 612 of various combinations thereof. In various embodiments, processor 606 may present a display of the determined tissue type 610 of the said portion of the tissue by using one or more of visual output, audio output, etc., or may present a display indicating that the determined tissue type 610 of the result matches the tissue type of the tissue at the target site 102, or may present both.

[0035] In summary, the medical device of the present disclosure measures the impedance of a part of the tissue that is in contact with each electrode provided at the tip of the device and placed at the target site. The medical device further determines the tissue type of the said part of the tissue based on the measured impedance. Based on this tissue type, the medical device controls the medical device tool at the tip of the device to ensure that the medical device tool is properly applied to the said part of the tissue at the target site. The approach of the present disclosure is advantageous in that the medical device applies the medical device tool to the tissue at the target site while avoiding the tissue of each part at other sites than the above.

[0036] At least one technical advantage of the medical device of the present disclosure when compared with the prior art is that the medical device of the present disclosure confirms that the medical device tool is placed at a given target position before operating the medical device tool. For example, the medical device of the present disclosure can also determine whether the tissue type of a part of the tissue in contact with each electrode at the tip of the device matches the expected tissue type of the target site before operating the medical device. In this way, the medical device of the present disclosure can apply various medical device tools to the tissues of various target sites more accurately than each conventional medical device. As a result, by using the medical device of the present disclosure, various treatment procedures can be carried out more accurately and reliably compared to those achievable with each conventional medical device. Specific examples include treatment procedures such as delivering a therapeutic agent or energy to a specific target site and extracting a tissue sample at a specific target site, but are not limited thereto. These technical advantages have brought about one or more technological advancements over the prior art approaches.

[0037] 1. In some embodiments, the medical device comprises a tip of the device provided with one or more pairs of electrodes and a medical device tool connected to a conduit, an impedance bridge, a processor connected to the impedance bridge and the conduit, and the like.

[0038] 2. In the medical device according to Item 1 above, the medical device tool includes a therapeutic agent delivery tool, and the catheter includes one or more therapeutic agent delivery catheters.

[0039] 3. In the medical device according to Item 1 or Item 2 above, the medical device tool includes an energy delivery tool, and the catheter includes one or more wires connecting the energy delivery tool to an energy source.

[0040] 4. In the medical device according to any one of Items 1 to 3 above, the medical device tool includes a tissue sample extraction tool, and the catheter includes one or more wires connecting the tissue sample extraction tool to an actuator.

[0041] 5. In the medical device according to any one of Items 1 to 4 above, the medical device tool is present between the electrodes of at least one pair of electrodes.

[0042] 6. In the medical device according to any one of Items 1 to 5 above, at least one electrode of a given pair of electrodes projects laterally outward with respect to the axis of the medical device tool.

[0043] 7. In the medical device according to any one of Items 1 to 6 above, at least one electrode of a given pair of electrodes is made of a flexible material.

[0044] 8. The medical device according to any one of Items 1 to 7 above further includes one or more actuators connected to a given pair of electrodes.

[0045] 9. The medical device according to any one of Items 1 to 8 above further includes an actuator connected to the medical device tool to project the medical device tool from a retracted position to an extended position.

[0046] 10. In some embodiments, a method of controlling a medical device includes recording one or more impedance measurement values associated with one or more electrode pairs provided at the leading end of the device at one or more frequencies, determining a tissue type of a portion of the tissue in contact with the one or more electrode pairs based on the one or more impedance measurement values, and controlling a medical device tool provided at the leading end of the device by performing one or more operations based on the tissue type.

[0047] 11. In the method of item 10 above, the step of determining the tissue type includes comparing the one or more impedance measurement values with one or more characteristic impedance measurement values associated with one or more tissue types.

[0048] 12. In the method of item 10 or item 11 above, the step of determining the tissue type includes determining a relaxation frequency of the portion of the tissue based on the one or more impedance measurement values, and comparing the relaxation frequency of the portion of the tissue with one or more specific relaxation frequencies of one or more tissue types.

[0049] 13. In any of the methods from item 10 to item 12 above, the relaxation frequency of the call corresponds to a frequency associated with the maximum impedance measurement value included in the one or more impedance measurement values.

[0050] 14. In any of the methods from item 10 to item 13 above, the step of determining the tissue type includes determining a tumor tissue type based on the relaxation frequency of the portion of the tissue above a threshold frequency, and determining a non-tumor tissue type based on the relaxation frequency of the portion of the tissue below the threshold frequency.

[0051] 15. In any of the methods from item 10 to item 14 above, the medical device tool includes a therapeutic agent delivery tool, and the step of controlling the medical device tool by performing one or more operations includes the step of delivering one or more therapeutic agents to the above-mentioned part of the tissue by operating the therapeutic agent delivery tool.

[0052] 16. In any of the methods from item 10 to item 15 above, the medical device tool includes an energy delivery tool, and the step of controlling the medical device tool by performing one or more operations includes the step of delivering energy to the above-mentioned part of the tissue by operating the energy delivery tool.

[0053] 17. In any of the methods from item 10 to item 16 above, the medical device tool includes a tissue sample extraction tool, and the step of controlling the medical device tool by performing one or more operations includes the step of extracting a tissue sample from the above-mentioned part of the tissue by operating the tissue sample extraction tool.

[0054] 18. In any of the methods from item 10 to item 17 above, the step of controlling the medical device tool by performing one or more operations includes at least one of the steps such as extending the medical device tool from the retracted position to the extended position, and retracting each electrode of at least one pair of electrode pairs from the extended position to the retracted position.

[0055] 19. Any of the methods from item 10 to item 18 above further includes the step of outputting at least one of visual display, audio display, etc. of the tissue type of the above-mentioned part of the tissue.

[0056] 20. Any of the methods from item 10 to item 19 above further includes the step of outputting at least one of visual display, audio display, etc. indicating that the tissue type of the above-mentioned part of the tissue matches the tissue type of the tissue at the target site.

[0057] Any one of the components claiming the patent described in any of the claims of the claims, any component described in the present application, or any combination of both, in any form, falls within the scope of the invention and the intended scope of protection of the present application.

[0058] Descriptions of various embodiments have been presented for illustrative purposes, but are not intended to cover all of them, that is, not intended to be limited to the embodiments of the present disclosure. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and essence of each embodiment described herein.

[0059] The various aspects of each embodiment of the present application can be embodied as a system, a method, or a computer program product. Accordingly, the various aspects of the present disclosure can take the form of a completely hardware embodiment, a completely software embodiment (including firmware, resident software, microcode, etc.), or an embodiment combining various software aspects and hardware aspects that are broadly referred to herein as "module", "system", or "computer". In addition, any of the hardware technologies, hardware processes, hardware functions, hardware components, hardware engines, hardware modules, or hardware systems described in the present disclosure, any of these software equivalents, or any of these hardware and software equivalents can be implemented as one circuit or a set of circuits. Furthermore, the various aspects of the present disclosure may take the form of a computer program product incorporated into one or more computer-readable media to embody computer-readable program code.

[0060] One or more computer-readable media can be used in any combination. The computer-readable media may be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium may be, for example, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, device, or any suitable combination thereof, but is not limited thereto. More specific examples (not an exhaustive list) of computer-readable storage media include the following: an electrical connection portion provided with one or more wires, a portable floppy disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM, flash memory, etc.), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination thereof. From the perspective of this specification, a computer-readable storage medium may be any tangible medium that can contain or store a program used by or in conjunction with an instruction execution system, an instruction execution apparatus, or an instruction execution device.

[0061] Various aspects of the present disclosure have been described up to this point with reference to flowcharts, block diagrams, or both, of methods, apparatus (systems), and computer program products according to embodiments of the present disclosure. It will be appreciated that each block in each flowchart illustration, each block diagram, or both, and various combinations of these blocks can be implemented by various computer program instructions. By providing these computer program instructions to the processor of a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus, a certain type of machine can be created. When these instructions are executed by the processor of a computer or other programmable data processing apparatus, the functions and various operations specified in one or more blocks of the flowchart, block diagram, or both can be realized. Such a processor may be, but is not limited to, various general-purpose processors, special-purpose processors, application-specific processors, field programmable gate arrays, and the like.

[0062] The flowcharts and block diagrams in the drawings illustrate the structure, functionality, and operation of possible implementations of various 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 that contains one or more executable instructions for implementing a particular logical function(s). It should also be noted that in alternative implementations, the functions represented within the blocks may occur in a different order than that shown in the drawings. For example, two blocks shown in succession may, in some cases, be executed substantially simultaneously, or depending on the relevant functionality, each block may be executed in the reverse order. It should also be noted that each block in the block diagrams, flowchart illustrations, or both, and various combinations of these blocks, may be implemented by a dedicated hardware-based system that performs the specified functions or operations, or by various combinations of dedicated hardware and computer instructions.

[0063] Up to the foregoing, each embodiment of the present disclosure has been targeted, and without departing from their basic scope, additional embodiments of the present disclosure other than the above may be devised, but their scope is determined by the appended claims. Hereinafter, preferred embodiments of the present invention will be described item by item. Embodiment 1 A medical device, including at least one set of electrode pairs and a medical device tool connected to a catheter as part of the component, at the leading end of the device, an impedance bridge, and a processor connected to the impedance bridge and the catheter. A medical device. Embodiment 2 The medical device tool includes a therapeutic agent delivery tool, and the catheter includes one or more therapeutic agent delivery catheters. The medical device according to Embodiment 1. Embodiment 3 The medical device tool includes an energy delivery tool, and the catheter includes one or more wires connecting the energy delivery tool to an energy source. The medical device according to Embodiment 1. Embodiment 4 The medical device tool includes a tissue sample extraction tool, and the catheter includes one or more wires connecting the tissue sample extraction tool to an actuator. The medical device according to Embodiment 1. Embodiment 5 The medical device tool is present between the electrodes of at least one set of electrode pairs. The medical device according to Embodiment 1. Embodiment 6 At least one electrode of a given electrode pair protrudes laterally outward with respect to the axis of the medical device tool. The medical device according to Embodiment 1. Embodiment 7 At least one electrode of a given electrode pair is made of a flexible material. The medical device according to Embodiment 1. Embodiment 8 Further comprising one or more actuators connected to a given electrode pair. The medical device according to Embodiment 1. Embodiment 9 Further comprising an actuator connected to the medical device tool to extend the medical device tool from a retracted position to an extended position. The medical device according to Embodiment 1. Embodiment 10 A method for controlling a medical device, recording one or more impedance measurement values associated with at least one set of electrode pairs included in the leading end of the medical device at one or more frequencies determining a tissue type of a part of the tissue in contact with the at least one set of electrode pairs based on the one or more impedance measurement values, and controlling the medical device tool included in the leading end of the device by performing one or more operations based on the tissue type. A method. Embodiment 11 The method according to embodiment 10, wherein the step of determining the tissue type includes comparing the one or more impedance measurement values with one or more characteristic impedance measurement values associated with one or more tissue types. Embodiment 12 The step of determining the tissue type includes: determining a relaxation frequency of the call of the part of the tissue based on the one or more impedance measurement values, and comparing the relaxation frequency of the call of the part of the tissue with the relaxation frequencies of one or more specific calls of one or more tissue types. The method according to embodiment 10. Embodiment 13 The method according to embodiment 12, wherein the relaxation frequency of the call corresponds to a frequency associated with the maximum impedance measurement value included in the one or more impedance measurement values. Embodiment 14 The step of determining the tissue type includes: determining a tumor tissue type based on the relaxation frequency of the call of the part of the tissue that exceeds a threshold frequency, or determining a non-tumor tissue type based on the relaxation frequency of the call of the part of the tissue that is below a threshold frequency. The method according to embodiment 12. Embodiment 15 The medical device tool includes a therapeutic agent delivery tool, and the step of controlling the medical device tool by performing one or more operations includes delivering one or more therapeutic agents to the part of the tissue by activating the therapeutic agent delivery tool. The method according to embodiment 10. Embodiment 16 The medical device tool includes an energy delivery tool, and the step of controlling the medical device tool by performing one or more operations includes delivering energy to the part of the tissue by activating the energy delivery tool. The method according to embodiment 10. Embodiment 17 The medical device tool includes a tissue sample extraction tool, and the step of controlling the medical device tool by performing one or more operations includes extracting a tissue sample from the part of the tissue by activating the tissue sample extraction tool. The method according to embodiment 10. Embodiment 18 The step of controlling the medical device tool by performing one or more operations includes: extending the medical device tool from a retracted position to an extended position, and including at least one of the steps of retracting each electrode of at least one pair of electrodes from the extended position to the retracted position. The method according to embodiment 10. Embodiment 19 The method according to Embodiment 10, further comprising a step of outputting at least one of a visual display and an audio display of the tissue type of the part of the tissue. Embodiment 20 The method according to Embodiment 10, further comprising a step of outputting at least one of a visual display and an audio display indicating that the tissue type of the part of the tissue matches the tissue type of the tissue at the target site.

Description of Symbols

[0064] 100 Medical device 104 Wire 106 External electrical component 108 Head of the device 202 Electrode pair 204 Medical device tool 302 Catheter 602 Amplifier 604 Impedance bridge 606 Processor 608 Impedance measurement value 610 Tissue type 612 Various operations

Claims

**Claim 1** A method of operating a medical device, the medical device comprising a processor, a medical device tool at the leading end of the device is located between the electrodes of one or more electrode pairs when viewed in the direction of the axis of the medical device tool, and the processor records one or more impedance measurement values associated with the one or more electrode pairs included in the leading end of the device at one or more frequencies, the processor compares the one or more impedance measurement values with one or more characteristic impedance measurement values associated with one or more tissue types to determine that the tissue type in contact with the one or more electrode pairs matches the tissue type of the target site tissue, and when the determined tissue type matches the tissue type of the target site tissue, the processor presents an indication that they match and, based on receiving a signal to activate the medical device tool, controls the medical device tool included in the leading end of the device to perform at least one of the following operations: (1) activating a therapeutic agent delivery tool, (2) activating an energy delivery tool, (3) activating a tissue sample extraction tool. **Claim 2** The step of determining the tissue type comprises the processor determining a relaxation frequency of a call of a portion of the tissue based on the one or more impedance measurement values, and the processor comparing the relaxation frequency of the call of the portion of the tissue with the relaxation frequencies of one or more specific calls of one or more tissue types. The method according to claim 1. **Claim 3** The relaxation frequency of the call corresponds to the frequency associated with the maximum impedance measurement value included in the one or more impedance measurement values. The method according to claim 2. **Claim 4** The step of determining the tissue type comprises the processor determining a tumor tissue type based on the relaxation frequency of a call of the portion of the tissue that exceeds a threshold frequency, or the processor determining a non-tumor tissue type based on the relaxation frequency of a call of the portion of the tissue that is below a threshold frequency. The method according to claim 2. **Claim 5** The medical device tool includes a therapeutic agent delivery tool, and the step of controlling the medical device tool includes the processor performing a step of operating the therapeutic agent delivery tool, the method according to claim 1.

6. The medical device tool includes an energy delivery tool, and the step of controlling the medical device tool includes the processor performing a step of operating the energy delivery tool, the method according to claim 1.

7. The medical device tool includes a tissue sample extraction tool, and the step of controlling the medical device tool includes the processor performing a step of operating the tissue sample extraction tool, the method according to claim 1.

8. The step of controlling the medical device tool is the step of the processor projecting the medical device tool from a retracted position to an extended position, and the method according to claim 1, including the processor performing at least one of the steps of retracting each electrode of at least one pair of electrode pairs from the extended position to the retracted position.

9. The display includes at least one of a visual display or an audio display, the method according to claim 1.

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