Thrombosis diagnostic guidewire

Abstract

The present disclosure relates to a medical device in the form of a medical guidewire. The medical guidewire may be used to deliver a catheter to a treatment site within a human vasculature and may be configured to simultaneously allow a user to determine the state of an occlusion within the human vasculature. The medical guidewire may be used to determine the degree of thrombus organization by sensing electrical resistance across the occlusion. The medical guidewire may include a hollow core through which at least two electrical wires extend over a portion or the entire length of the medical guidewire from a proximal end to a distal end of the medical guidewire. The medical guidewire may include two or more sensors in its distal portion, the sensors being spaced apart from one another.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 309326, filed February 11, 2022, which is incorporated herein by reference in its entirety.

[0002] (Technical field) The present disclosure relates to a medical device in the form of a medical guidewire and a method of using the medical device to diagnose thrombi and cancer cells and provide optimal treatment. The medical guidewire can be used to deliver a catheter to a treatment site in an animal or human vasculature and can be configured to simultaneously allow a user to determine the status of an occlusion in the animal or human vasculature. The medical guidewire can be used to determine the degree of organization of a thrombi by detecting electrical resistance through the occlusion and / or to detect the presence of cancer cells in blood flowing through a vessel. The medical guidewire can include a hollow core through which at least two electrical wires extend over some or all of the length of the medical guidewire from a proximal end to a distal end of the medical guidewire. The medical guidewire can include two or more sensors in its distal end region, and the two or more sensors can be spaced apart from one another. A low current can be induced in one or more first sensors while the medical guidewire is in use. Thus, signals from a thrombi in the animal or human vasculature can be detected by one or more of the second sensors. This detected signal can be converted into an impedance value, or some other value, to identify the thrombus type within the animal or human vasculature. The medical guidewire can be used to assist physicians in selecting the appropriate thrombus removal technique to achieve optimal patient recovery. The received signal can also, or instead, be used to detect the presence of cancer cells in the blood flowing through the medical guidewire. [Background technology]

[0003] Stenosis in blood vessels occurs due to the formation of plaque or thrombus in the blood vessel. The modern approach to relieve stenosis is by angioplasty, which dilates the blood vessel with a balloon catheter. However, angioplasty cannot treat all stenosed blood vessels, especially those in neurovascular arteries. Most occlusions that lead to strokes are due to the formation of a thrombus at the occlusion site or a thromboembolism originating from another site in the arterial system. It is well known that the majority of lesions involving thrombus are not previously identified as thrombosis on thrombograms, and the thrombus may be overshadowed by the necrotic core of the plaque. The thrombus is underrepresented, while the calcium is overrepresented. In either case, the optimal solution would be removal of the thrombus by thrombectomy or simple aspiration.

[0004] Thrombi are typically formed by plaque rupture. New thrombi are soft and become more organized and fibrous over time. New thrombi are relatively easier to remove than older, organized thrombi. Physicians have reported that there is a sensory difference when crossing the thrombus with a guidewire, which gives the physician some idea of ​​the extent of the thrombus. Depending on the extent to which the thrombus is organized, appropriate treatment is applied. Generally, soft thrombi are easily removed using an aspiration catheter, while organized thrombi may require aspiration or the use of a stent retriever after lysis of the thrombus. When the thrombus is severely organized and hardened, more extreme techniques such as rotational or vibratory thrombectomy devices are used.

[0005] More recent medical device developments include devices that combine atherectomy with aspiration or stent retriever with aspiration. This approach is effective in many cases where there is a thrombus with an organization radiating from the wall to the center of the vessel. However, without knowing the exact status of the thrombus, it is very likely that treatment with various devices will be overly aggressive, which may lead to adverse effects such as avulsion or embolization. Meanwhile, less aggressive treatments may leave some of the stenosed vessels.

[0006] During the clot formation process, the structure and composition of blood change. The structural changes during blood clotting cause changes in blood conductivity. With the evolution of the clotting process and blood conductivity measurements, a decrease in blood conductivity has been observed. As the hematocrit level increases, the relative blood conductivity decreases. The absolute change in conductivity (Δσ) is equal to the difference between the blood conductivity at complete clotting (σc) and the blood conductivity at the beginning of the clotting process (σs), and is given by: Δσ=│σc-σs│

[0007] Besides blood clots, the rate at which cancer cells spread can also be detected by differences in electrical conductivity. Poorly differentiated cancer cells grow and spread more slowly than properly differentiated cancer cells. It has been observed that poorly differentiated cancer cells have a higher electrical conductivity than normal cells.

[0008] There is an unmet need to diagnose thrombus and cancer cells and provide appropriate treatment. The medical device according to the present disclosure addresses the shortfalls of current devices and fills the medical need by providing caregivers with a way to accurately identify the state of stenosis and subsequently carefully select a treatment modality. Summary of the Invention [Means for solving the problem]

[0009] In one non-limiting embodiment of the present disclosure, a medical device in the form of a medical guidewire and a method of using the medical device to diagnose thrombi and cancer cells and provide appropriate treatment are provided. The medical guidewire can be used to deliver a catheter to a treatment site in an animal or human vasculature and can be configured to simultaneously allow a user to determine the state of an occlusion in the animal or human vasculature. The medical guidewire can be used to determine the degree of organization of a thrombus by detecting electrical resistance across the occlusion and / or to detect the presence of cancer cells in blood flowing through a vessel. The medical guidewire can include a hollow core through which at least two electrical wires extend over a portion or the entire length of the medical guidewire from a proximal end to a distal end of the medical guidewire. The medical guidewire can include two or more sensors in its distal end region, the two or more sensors being spaced apart from one another. During use of the medical guidewire, a low current can be induced in one or more first sensors. A signal from a thrombus in the animal or human vasculature can then be detected by one or more of the second sensors. This detected signal can be converted to an impedance value or some other value to identify the thrombus type within the animal or human vasculature. The medical guidewire can be used to assist physicians in selecting an appropriate thrombectomy procedure to achieve optimal patient recovery. The received signal can also, or instead, be used to detect the presence of cancer cells in the blood flowing through the medical guidewire.

[0010] According to other non-limiting aspects of the present disclosure, a medical guidewire is directed to, but is not limited to, determining one or more attributes of a stenosis in the diagnosis of a stenosis in a blood vessel and in the vascular treatment of the stenosis by determining the impedance of an electrical current across the stenosis.

[0011] According to other non-limiting aspects of the present disclosure, the medical guidewire is directed to, but is not limited to, detecting cancer cells in blood flowing through a blood vessel by determining the impedance of electrical current within the vessel.

[0012] According to another non-limiting aspect of the present disclosure, the medical guidewire includes a body (e.g., a tubular body, a semi-tubular body, a solid body, etc.) extending partially or completely along the longitudinal length of the medical guidewire and at least one sensor. Typically, the medical guidewire includes two or more sensors at or near the distal end of the medical guidewire. Typically, the one or more sensors are located closer to the distal end of the medical guidewire than to the proximal end of the medical guidewire. In one non-limiting embodiment, the one or more sensors are located 0-20% (and all values ​​and ranges therebetween) of the longitudinal length of the medical guidewire body from the distal end of the medical guidewire, typically the one or more sensors are located 0.5-10% of the longitudinal length of the medical guidewire body from the distal end of the medical guidewire. In one non-limiting configuration, the one or more sensors are located away from the distal end of the medical guidewire. In another non-limiting configuration, all sensors are located away from the distal end of the medical guidewire. In other non-limiting configurations, two or more sensors are positioned at different distances from the distal end of the medical guidewire. When the medical guidewire includes two or more sensors, the sensors are generally positioned at a predetermined distance apart along the longitudinal length of the medical guidewire, but this is not required. The sensors are positioned at or near the distal end of the medical guidewire. When one sensor is positioned at or near the distal end of the medical guidewire, the other sensor is generally positioned on the body of the medical guidewire and distally away from the sensor at or near the distal end along the longitudinal axis of the medical guidewire. As can be appreciated, two or more of the sensors may be positioned away from the distal end of the medical guidewire, but may also be positioned near the distal end of the medical guidewire. One or more sensors may be positioned such that 1) at least one of the sensors is at least partially exposed to the outer surface of the medical guidewire, and / or 2) at least one of the sensors is located inside the medical guidewire.In one non-limiting configuration, all of the sensors may be at least partially disposed on the outer surface of the medical guidewire. In another non-limiting configuration, all of the sensors may be disposed within the medical guidewire and spaced apart from the outer surface of the medical guidewire. In another non-limiting configuration, at least one of the sensors may be at least partially disposed on the outer surface of the medical guidewire and at least one of the sensors may be disposed within the medical guidewire and spaced apart from the outer surface of the medical guidewire. The material from which the sensors are formed is not limited. In another non-limiting embodiment, the one or more sensors may be formed of or include a metal such as, but not limited to, gold, platinum, titanium, and the like. The size and shape of the one or more sensors is not limited. In another non-limiting embodiment, the one or more sensors have an upper end surface having a circular, square, oval, polygonal, obround, and the like shape and a maximum dimension of at least 10 μm (e.g., 10-350 μm, and all values ​​and ranges therebetween). In other non-limiting embodiments, the sensor or sensors may be in the form of a band that partially or completely encircles the outer surface of the body of the medical guidewire. In one non-limiting configuration, the band has a maximum width of at least 10 μm (e.g., 10-350 μm, and all values ​​and ranges therebetween), typically 100-240 μm. In other non-limiting embodiments, the sensor or sensors may have a circular, square, triangular, oval, polygonal, etc. shape, with the maximum cross-sectional dimension of the sensor or sensors on the outer surface of the medical guidewire being at least 10 μm (e.g., 10-350 μm, and all values ​​and ranges therebetween), typically 100-240 μm. As can be appreciated, the sensor or sensors may be larger (e.g., up to the entire length of the medical device). Generally, when more than one sensor is used, at least two of the sensors have the same shape, size, and / or are formed of the same material. The distance that two or more sensors on a medical guidewire are separated from each other is not limited.In one non-limiting embodiment, the two or more sensors on the medical guidewire are spaced apart from one another by a distance of at least about 100 μm (e.g., 100-800 μm, and all values ​​and ranges therebetween), typically 300-400 μm. As can be appreciated, when one or more sensors are used on other types of medical devices (e.g., stents, balloon guides, catheters, etc.), the same or similar parameters of the sensors may optionally be used.

[0013] According to another non-limiting aspect of the present disclosure, the medical guidewire optionally includes a hollow body or tube (e.g., a hollow tubular body, etc.) that extends partially or entirely through the longitudinal length of the medical guidewire. In one non-limiting embodiment, the longitudinal length of the cavity within the tube is at least 10% (e.g., 10-100%, and all values ​​and ranges therebetween) of the longitudinal length of the tube. At least one, and generally at least two, electrical wires are disposed within the cavity of the tube and extend from a location at or near the proximal end of the medical guidewire to each of the sensors disposed at or near the distal end of the medical guidewire. At or near the proximal end of the medical guidewire, the one or more electrical wires can be connected to an electrical circuit source that can transmit an electrical current through at least one of the electrical wires to one or more sensors. A current source or some other detection device can be used to detect the electrical current from one or more of the sensors through one or more of the electrical wires. In one non-limiting configuration, one electrical line is used to transmit current from a current source to one or more sensors, and another electrical line is used to transmit current from one or more other sensors to a current source or some other sensing device.

[0014] According to another non-limiting aspect of the present disclosure, the medical guidewire optionally includes a body or tube having a distal portion, the distal portion including one or more cutouts for forming a soft tip region on the medical guidewire to increase the softness of the distal region of the medical guidewire. Such a soft tip region facilitates insertion of the medical guidewire into the vasculature of a patient. The shape of each of the cutout patterns on the soft tip region is not limited. In one non-limiting embodiment, the soft tip includes multiple cutout pattern portions. In other non-limiting embodiments, the shapes and / or sizes of two or more cutout portions are the same. In other non-limiting embodiments, the cutouts on the distal portion of the medical guidewire comprise at least 10% (e.g., 10-75%, and all values ​​and ranges therebetween) of the surface area of ​​the medical guidewire at such distal end. In other non-limiting embodiments, the one or more cutout patterns are disposed distal to the sensor of the medical guidewire. In other non-limiting embodiments, the one or more cut out patterns extend from a region on the medical guidewire proximal to the sensor to a region on the medical guidewire distal to the sensor of the medical guidewire, hi other non-limiting embodiments, the one or more cut out patterns are formed in the body of the medical guidewire and the depth of the one or more cut out patterns extends partially or completely through the wall of the body or tube.

[0015] According to other non-limiting aspects of the present disclosure, the medical guidewire optionally includes a body or tube having a distal end, the distal end being tapered from a proximal end of the distal end to a distal end of the distal end. The tapered portion is optionally coated with a coating of polymeric material, the polymeric material optionally including radiopaque materials and / or particles. The tapered portion facilitates softening of the medical guidewire when inserted into and through a body passageway, such as a blood vessel. Thus, the soft tip (when used) can facilitate insertion of the medical guidewire into a patient's vasculature.

[0016] According to other non-limiting aspects of the present disclosure, the shape and placement of the sensors on the medical guidewire are selected to obtain accurate electrical signal processing of the signal detected from the vasculature. Contact impedance varies with the size of various sensors and their surface area in contact with the thrombus. Sensors with larger surface areas can detect a larger surface area of ​​the thrombus, which can measure the impedance across the thrombus. Conversely, sensors with smaller surface areas can measure more precise points along the thrombus. With regard to sensor placement, the spacing between sensors affects the penetration of current and the area the current travels, and therefore the signal detected.

[0017] According to another non-limiting aspect of the present disclosure, one non-limiting advantage of using a medical guidewire according to the present disclosure is to increase the success rate of first-stage thrombectomy. The medical guidewire can be used to accurately identify the composition of the thrombus based on the impedance value captured and measured from the sensor when in direct contact with the thrombus. This technology of identifying the composition of the thrombus through a medical guidewire is believed to be novel. Currently, there is no effective method to identify the stiffness of a thrombus in the vasculature. Therefore, until now, physicians have only been able to use a trial-and-error method to remove the thrombus. By using a medical guidewire according to the present disclosure to measure the composition and / or stiffness of the thrombus, physicians can measure the thrombus impedance, thereby classifying the attributes of the thrombus more effectively and accurately. The stiffness of the thrombus can be interpreted from the thrombus impedance, and a treatment plan can be determined. Therefore, effectively classifying the thrombus will greatly improve the success rate of first-stage thrombectomy.

[0018] According to other non-limiting aspects of the present disclosure, one or more of the sensors are located on the outer surface of the body or tube of the medical guidewire. In one non-limiting embodiment, all of the sensors are located on the outer surface of the body or tube of the medical guidewire. In one non-limiting embodiment, the outer surface of the tube includes a recess for one or more of the sensors such that when the sensor is connected to the outer surface of the body or tube, the top of the sensor is flush with or in a recessed position with the top surface of the body or tube, but this is not required. In other non-limiting embodiments, the body or tube includes a line opening for one or all of the sensors connected to the outer surface of the body or tube, e.g., the line connected to the sensor can pass from the sensor through the line opening and into the internal cavity of the body or tube. Such a structure can be used to partially or completely prevent the line connected to the sensor from being exposed to the outer surface of the body or tube. In other non-limiting structures, the line opening is located in one or more of the recesses for the sensor.

[0019] According to another non-limiting aspect of the present disclosure, a noise sensor is provided that reduces or eliminates noise received from other sensors on the guidewire. The noise sensor may optionally be connected to electronic circuitry (e.g., differential amplifier, amplifier noise canceller, etc.) to help eliminate noise. For example, the noise sensor may function as a differential probe that is used as a reference for the signal received from the sensor. The noise sensor may optionally be used to look at small signals in the presence of a large DC offset. The DC offset shift may be many times higher than the amplitude of the signal to be sensed. By using a differential probe, it has a larger common mode rejection that can extract small signals in high shift signals. By doing this, a cleaner signal (unshifted and small noise signal) can be obtained. For example, a single signal from one of the sensor and noise sensor may be amplified before being converted to a single-ended signal. After amplification, the two signals may be passed through a differential to single-ended converter. During this step, the single-ended signal may be filtered from noise and offset with its high common mode rejection. The output signal of this circuit may then be input to a frequency generator, which, as can be appreciated, may also include an additional module (e.g., a differential electrometer amplifier (DEA)) to convert from a differential input to a single-ended output.

[0020] According to another non-limiting aspect of the present disclosure, an optional substrate is provided that can be partially disposed within the tube of the guidewire. The sensor may optionally be located on the substrate. Thus, the substrate can be used as a fixation surface for one or more sensors. The one or more sensors may be fixed to the substrate by various structures (e.g., adhesive, fusion connection, soldering, friction fit, hook and loop fastener, etc.). Wires and / or connection pads may optionally be located on the surface and / or within the substrate. As can be appreciated, one or more sensors, wires, and / or connection pads may be printed (e.g., 3D printed, photoetched, etc.) on the substrate. The substrate (when used) is generally formed of a low conductive material or a non-conductive material (e.g., polymer, plastic, foam material, rubber, ceramic, composite material, etc.). The substrate may have a cross-sectional shape that is the same as or similar to the cross-sectional shape of the cavity of the tube. The length of the substrate is generally about 0.1-25% (and all values ​​and ranges therebetween) of the longitudinal length of the tube. Typically, the substrate is located at a distance of 0.01 to 25% (and all values ​​and ranges therebetween) of the tube's longitudinal length from the distal end of the tube. The substrate may be at least partially secured within the body or tube cavity by various structures (e.g., adhesive, fusion connection, soldering, friction fit, hook and loop fastener, etc.). The substrate may optionally include a cut or skived area such that when the sensor is connected to the cut or skived area and the substrate is secured within the body or tube cavity, the top surface of the sensor is flush with or in a recessed position relative to the outer surface of the body or tube. When a substrate is used, the body or tube may optionally include a sensor cut-out area. The cut-out area places the sensor on the substrate in direct contact with the thrombus when the guidewire is inserted into the vasculature. The cut-out area is typically located at the distal portion of the body or tube. The location of the cutout is generally located from the distal end of the body or tube about 0.1-25% (and all values ​​and ranges therebetween) of the longitudinal length of the tube.The length of the cutout is generally about 0.1-25% of the longitudinal length of the tube (and all values ​​and ranges therebetween). The longitudinal length of the substrate is generally equal to or greater than the longitudinal length of the cutout. The width of the substrate is generally equal to or greater than the width of the cutout.

[0021] In accordance with one non-limiting aspect of the present disclosure, a medical diagnostic system is provided that includes: a) a medical device; b) an electrical assembly distal to the medical device for transmitting and receiving electrical signals at a diagnostic site; and c) an analyzer that optionally includes a user interface for analyzing collected data and processing and / or displaying results.

[0022] According to another non-limiting aspect of the present disclosure, the medical guidewire, when in direct contact with the tumor, can be used to accurately identify how undifferentiated the cancerous tissue is based on the measured impedance values ​​captured from the sensor.

[0023] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which an electrical assembly includes one or more sensors.

[0024] In accordance with other non-limiting aspects of the present disclosure, a medical diagnostic system is provided in which the sensors may have other configurations in terms of shape, number, placement, and size.

[0025] In accordance with another non-limiting aspect of the present disclosure, a medical diagnostic system is provided in which sensors may optionally be printed onto a soft substrate or formed in other ways (e.g., 3D printed, photo-etched, plated, adhesively bonded, cast, etc.) onto the substrate.

[0026] In accordance with another non-limiting aspect of the present disclosure, a medical innovation system is provided in which sensors of the medical device may be removed and other sensors may be attached to obtain more information for diagnosis. These sensors may obtain data including, but not limited to, shear force, pressure, impedance, dissipation, strain, and flow data.

[0027] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system further comprising conductive metal and / or connection pads optionally printed or otherwise formed (e.g., 3D printed, photo-etched, plated, adhesively bonded, cast, etc.) on the soft substrate having the sensor.

[0028] In accordance with another non-limiting aspect of the present disclosure, a medical diagnostic system is provided in which a connection pad connects to an electrical assembly within a medical device.

[0029] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which an electrical assembly includes one or more electrical lines.

[0030] According to another non-limiting aspect of the present disclosure, a medical diagnostic system is provided in which an electrical assembly is electrically connected to an impedance analyzer and optionally includes a user interface for forming a closed loop circuit.

[0031] In accordance with another non-limiting aspect of the present disclosure, a medical diagnostic system is provided in which an electrical assembly is connected to an alternating current.

[0032] In accordance with another non-limiting aspect of the present disclosure, the medical device is a guidewire, the guidewire optionally including a hollow proximal section transitioning to a solid core distal section, the solid core distal section of the guidewire optionally featuring cuts and voids that soften the guidewire to reach tortuous areas, one or more electrical sensors disposed near the distal end of the guidewire, electrical wires configured to connect the electrical sensors to an analyzer are routed through the hollow guidewire, and an optional solid core support wire routed through the hollow guidewire increases the pushability of the guidewire, providing a medical diagnostic system.

[0033] In accordance with another non-limiting aspect of the present disclosure, a medical diagnostic system is provided that includes a tissue sensor interface disposed in a distal hollow portion of a guidewire, the tissue sensor interface including a cut-out area that allows the sensor to directly contact tissue.

[0034] In accordance with another non-limiting aspect of the present disclosure, a medical diagnostic system is provided in which a guidewire is introduced into a vascular passageway of a body and guided along the vessel to a site of a thrombus, and an electrical sensor contacts tissue to obtain a signal for analyzing tissue composition.

[0035] In accordance with another non-limiting aspect of the present disclosure, a medical diagnostic system is provided in which the solid core support wire is optionally replaced with a single electrical wire connecting the electrical sensor to the analyzer.

[0036] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which the medical device is a stent.

[0037] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which the medical device is a balloon guidewire.

[0038] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which the medical device is a catheter.

[0039] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system comprising: a) a medical device configured for insertion into a blood vessel of an animal or human, the medical device including a distal portion having a distal end and a proximal portion having a proximal end; b) an electrical assembly disposed at least partially in the distal portion of the medical device, the electrical assembly including a first sensor and a second sensor disposed in the distal portion of the medical device, the electrical assembly configured to transmit and receive one or more electrical signals to a diagnostic site when the distal portion of the medical device is disposed at the diagnostic site; and c) an impedance analyzer configured to analyze the one or more signals received from the electrical assembly.

[0040] Another non-limiting aspect of the present disclosure provides a medical diagnostic system, wherein the medical device is selected from the group consisting of a guidewire, a balloon guidewire, a stent retriever, or a catheter.

[0041] In accordance with another non-limiting aspect of the present disclosure, a medical device provides a medical diagnostic system including a radiopaque marker located a) proximate to one of the first sensor or the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor.

[0042] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which the electrical assembly includes a noise reduction sensor located on a distal portion of the medical device, the noise reduction sensor being located away from the first sensor and the second sensor, the noise reduction sensor being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor.

[0043] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system further comprising an electronic circuit selected from the group consisting of a differential amplifier and an amplifier noise canceller.

[0044] According to another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which a first sensor or a second sensor is exposed on an outer surface of the medical device such that at least a portion of the first sensor or the second sensor can contact an inner wall of a blood vessel or a substance disposed on the inner wall of a blood vessel when a distal portion of the medical device is positioned at a diagnostic site.

[0045] According to another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system, wherein the medical device includes a tube, an outer surface of the tube includes a first sensor recess and a second sensor recess, the first sensor recess configured to at least partially receive a first sensor, the second sensor recess configured to at least partially receive a second sensor, an upper end surface of the first sensor being flush or recessed with the outer surface of the tube when the first sensor is located within the first sensor recess, and an upper end surface of the second sensor being flush or recessed with the outer surface of the tube when the second sensor is located within the second sensor recess.

[0046] In accordance with another non-limiting aspect of the present disclosure, a medical device provides a medical diagnostic system including a tube including an interior cavity extending at least 60% of a longitudinal length of the tube, an electrical assembly including a first wire electrically connected to a first sensor and a second wire electrically connected to a second sensor, the first wire and the second wire being located within at least 50% of the longitudinal length of the cavity of the tube.

[0047] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which a majority of the longitudinal lengths of first and second wires disposed within a cavity are not connected to the cavity.

[0048] In accordance with another non-limiting aspect of the present disclosure, a medical diagnostic system is provided in which a distal portion of the tube includes one or more depressions or cutouts configured to increase flexibility of the distal portion of the tube, the one or more depressions or cutouts being located a) proximal to the first and second sensors, b) between the first and second sensors, or c) distal to the first and second sensors.

[0049] In accordance with another non-limiting aspect of the present disclosure, a medical diagnostic system is provided in which a medical device is disposed within a cavity of a tube and includes a rod extending from a proximal end of the tube to a distal portion of the tube, the majority of the length of the rod being unconnected to the cavity.

[0050] According to another non-limiting aspect of the present disclosure, a medical diagnostic system is provided in which a medical device includes a tube substrate positioned at least partially within a cavity of a tube, a first sensor and a second sensor are coupled to a top surface of the tube substrate, and the tube substrate is formed of a material different from the tube.

[0051] According to another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which a tube substrate includes a skived region, the skived region reducing a cross-sectional area of ​​the skived region compared to a region of the tube substrate located proximal and / or distal to the skived region, and a first sensor and a second sensor are located at least partially on the skived region.

[0052] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which the tube substrate has a longitudinal length that is 1-25% of the longitudinal length of the tube, and the tube substrate has a cross-sectional shape that is the same as or similar to the cross-sectional shape of the cavity of the tube.

[0053] According to another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which the tube includes a cutout region located at a distal portion of the tube, and the tube substrate is positioned within the cavity and oriented relative to the cutout region such that top surfaces of a first sensor and a second sensor connected to the top surface of the tube substrate are exposed to an outer surface of the medical device.

[0054] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which the medical device is a balloon guidewire, the balloon guidewire including a tube and an inflatable balloon, and an outer surface of the balloon including a first sensor and a second sensor.

[0055] According to another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system wherein the medical device is a stent retriever, the stent retriever including a plurality of interconnected wires, and a first sensor and a second sensor are connected to an outer surface of the interconnected wires.

[0056] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which a distal portion of a medical device includes a tapered region.

[0057] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical diagnostic system in which a distal tapered region is coated with a radiopaque material.

[0058] In accordance with another non-limiting aspect of the present disclosure, there is provided a method of using a medical diagnostic system to a) obtain one or more attributes of a thrombus in a blood vessel and / or b) identify the presence or entity of cancer cells flowing within the blood vessel.

[0059] In accordance with another non-limiting aspect of the present disclosure, there is provided a medical device configured for insertion into a blood vessel of an animal or human, the medical device comprising a tube and an electrical assembly, the tube comprising an internal cavity extending at least 60% of a longitudinal length of the tube, the tube having a distal portion having a distal end and a proximal portion having a proximal end, the electrical assembly disposed at least in the distal portion of the medical device, the electrical assembly comprising a first sensor and a second sensor, the electrical assembly comprising a first wire electrically connected to the first sensor and a second wire electrically connected to the second sensor, the first wire and the second wire being located within at least 50% of the longitudinal length of the cavity of the tube, the first sensor and the second sensor being disposed in the distal portion of the medical device, and the electrical assembly configured to transmit or receive one or more electrical signals to a diagnostic site when the distal portion of the medical device is disposed at the diagnostic site.

[0060] These and other advantages of the present disclosure will become more apparent to those of ordinary skill in the art after reviewing the following description of the preferred embodiments and claims. [Brief description of the drawings]

[0061] Reference may now be made to the Figures which illustrate various embodiments that the present disclosure may take in physical form and specific components and configurations of the components.

[0062] [Figure 1-1]FIG. 1-1 is a cross-sectional view of a portion of an exemplary embodiment of a diagnostic medical guidewire having a sensor according to the present disclosure.

[0063] [Figure 1-2] FIG. 1-2 is a top view of a portion of the diagnostic medical guidewire shown in FIG. 1-1.

[0064] [Figure 1-3] FIG. 1-3 is a partial cross-sectional view of a portion of a variation of the diagnostic medical guidewire shown in FIG. 1-1.

[0065] [Figure 1-4] FIG. 1-4 is an enlarged cross-sectional view of the diagnostic medical guidewire shown in FIG. 1-1, showing a sensor on a portion of the medical guidewire.

[0066] [Figure 2-1] FIG. 2-1 is a cross-sectional view of a portion of the diagnostic medical guidewire shown in FIG. 1-1, showing the medical guidewire connected to a current source and / or a current sensing source.

[0067] [Figure 2-2] FIG. 2-2 is a cross-sectional view of a portion of the diagnostic medical guidewire shown in FIG. 1-1, showing the medical guidewire disconnected from the current source and / or current sensing source.

[0068] [Diagram 3] FIG. 3 is a cross-sectional view of a portion of the diagnostic medical guidewire shown in FIG. 1-1, illustrating a non-limiting electrical impedance measurement system for the medical guidewire.

[0069] [Figure 4-1] FIG. 4-1 is a portion of an electrical circuit that may be used in an electrical impedance measurement system for a medical guidewire.

[0070] [Figure 4-2] FIG. 4-2 is a portion of an electrical circuit that may be used in an electrical impedance measurement system for a medical guidewire.

[0071] [Figure 4-3] FIG. 4-3 is a portion of an electrical circuit that may be used in an electrical impedance measurement system for a medical guidewire.

[0072] [Figure 4-4] FIG. 4-4 is a portion of an electrical circuit that may be used in an electrical impedance measurement system for a medical guidewire.

[0073] [Figure 5-1] FIG. 5-1 is an enlarged cross-sectional view of the diagnostic medical guidewire shown in FIG. 1-1, showing the medical guidewire utilized inside a blood vessel with two sensors on the medical guidewire positioned across a stenosis within the blood vessel.

[0074] [Figure 5-2] FIG. 5-2 is another enlarged cross-sectional view of the diagnostic medical guidewire shown in FIG. 1-1, showing the medical guidewire utilized inside a blood vessel with two sensors (e.g., ring electrodes) on the medical guidewire positioned across a stenosis within the blood vessel.

[0075] [Figure 6-1] FIG. 6-1 is an enlarged cross-sectional view of an alternative to the diagnostic medical guidewire shown in FIG. 1-1, illustrating a diagnostic guidewire without a solid core support.

[0076] [Figure 6-2] FIG. 6-2 is an enlarged cross-sectional view of another alternative of the diagnostic medical guidewire shown in FIG. 1-1, showing a diagnostic guidewire without a solid core support.

[0077] [Figure 7]FIG. 7 is an enlarged isometric view of the diagnostic medical guidewire shown in FIG. 1-1, showing one of the electrical wires replaced by a solid core support wire inside the diagnostic medical guidewire.

[0078] [Figure 8] FIG. 8 is another embodiment of the present disclosure showing one or more sensors disposed on a stent retriever.

[0079] [Figure 9-1] FIG. 9-1 is another embodiment of the present disclosure showing a cross-sectional view of a balloon guidewire including one or more sensors.

[0080] [Figure 9-2] FIG. 9-2 is an enlarged isometric view of the balloon guidewire of FIG. 9-1 showing one or more sensors on the balloon guidewire.

[0081] [Figure 10-1] FIG. 10-1 is an enlarged partial isometric view of a medical guidewire that includes four sensors on the medical guidewire.

[0082] [Figure 10-2] FIG. 10-2 is an enlarged partial isometric view of a medical guidewire that includes six sensors on the medical guidewire.

[0083] [Figure 10-3] FIG. 10-3 is another enlarged partial isometric view of a medical guidewire including six sensors thereon.

[0084] [Figure 10-4] FIG. 10-4 is a top view of the medical guidewire of FIG. 10-3.

[0085] [Figure 11]FIG. 11 is another enlarged partial isometric view of a medical guidewire that includes a tapered tip and can optionally be flexible, the tapered tip optionally including a coating, and the coating can optionally include a radiopaque material.

[0086] [Figure 12] FIG. 12 is a portion of an electrical circuit that may be used in an electrical impedance measurement system having a differential amplifier for a medical guidewire.

[0087] [Figure 13] FIG. 13 is an expanded isometric view of a medical guidewire having a separable sensor design. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0088] A more complete understanding of the articles / devices, processes and components disclosed herein can be obtained by reference to the accompanying drawings, which are merely schematic depictions for convenience and ease of illustrating the disclosure, and are therefore not intended to indicate the relative size and dimensions of the devices and components thereof, and / or to define or limit the scope of the exemplary embodiments.

[0089] For purposes of clarity, specific language will be used in the following description, however, these language are intended merely to refer to the particular structure of the embodiments selected for depiction in the drawings, and are not intended to define or limit the scope of the present disclosure. In the drawings and the following description, it will be understood that like numeric designations refer to components of similar functionality.

[0090] Singular forms ("a", "an", "the") include plural referents unless the context clearly dictates otherwise.

[0091] As used in the specification and claims, the term "comprising" may include the embodiments "consisting of" and "consisting essentially of." As used herein, the terms "comprising," "including," "having," "having," "capable," "including," and variations thereof are intended as open-ended transitional phrases, terms, or phrases requiring the presence of the recited components / steps and permitting the presence of other components / steps. However, such descriptions "consisting of" and "consisting essentially of" the recited components / steps should likewise be construed as describing a composition or process permitting the presence of only the recited components / steps together with any unavoidable impurities resulting therefrom, and excluding other components / steps.

[0092] Numerical values ​​in the specification and claims of this application should be understood to include numerical values ​​that are the same when subtracted to the same number of significant digits, and numerical values ​​that differ from the stated value by less than the experimental error of ordinary measuring techniques of the type described in this application for determining the value.

[0093] All ranges described herein are inclusive of the recited endpoints and are independently combinable (e.g., the range "from 2 grams to 10 grams" includes the endpoints 2 grams and 10 grams, and all values ​​in between).

[0094] The terms "about" and "approximately" can be used to include any numerical value that can be varied without changing the fundamental function of its value. When used in a range, "about" and "approximately" also represent a range defined by the absolute values ​​of the two endpoints, for example, "about 2 to about 4" also represents the range "2 to 4." In general, the terms "about" and "approximately" can represent plus or minus 10% of the specified number.

[0095] Referring now to the figures, there are shown non-limiting embodiments of a medical guidewire according to the present disclosure that can be used to effectively classify thrombus and greatly increase the success rate of first-stage thrombectomy procedures.

[0096] Thrombi can block or narrow arteries leading to the brain, thereby causing ischemic stroke. Thrombi are typically formed by plaque rupture. The main components of thrombi are fibrin and red blood cells. Depending on the ratio, thrombi can be classified as fibrin-rich and red blood cell-rich. The stiffness of a thrombus is related to its composition.

[0097] In addition to plaque rupture, a rarer cause of ischemic stroke can result from an occlusion. This occurs when a blood clot forms somewhere in the body, ruptures as an embolus, and travels through the bloodstream to the brain. These types of clots usually become calcified, forming what is known as a calcific cerebral occlusion (CCE).

[0098] Generally, a thrombus does not have a fixed shape. The shape of a thrombus changes depending on the shape of the blood vessel. The ability to mold to the shape of the blood vessel also depends on the rigidity of the thrombus itself.

[0099] 1-1, 1-2, and 1-3, there is shown an exemplary embodiment of a medical device in the form of a diagnostic guidewire 100 including a tube 115 and sensors 104a, 104b. As can be appreciated, other types of medical devices according to the present disclosure may be used in conjunction with the sensors to detect or obtain attributes of a thrombus 301 in the vasculature (see FIGS. 8, 9-1, and 9-2).

[0100] 1-1, 1-2, and 1-3, guidewire 100 includes tube 115, which includes cavity 117 extending over some or all of its longitudinal length. In one non-limiting configuration, cavity 117 extends 3-100% (and all values ​​and ranges therebetween) of the longitudinal length of tube 115. Generally, the cross-sectional shape and size of the cavity is constant over the longitudinal length of cavity 117, although this is not required. In one non-limiting configuration, cavity 117 has a generally circular cross-sectional shape, although other shapes (e.g., polygonal, oval, etc.) may be used. The tube may be formed of a variety of materials (e.g., metals, plastics, composites, etc.). In one non-limiting configuration, tube 115 is formed of a metal such as Nitinol, SS, CoCr, Re alloys, Mo alloys, etc.

[0101] 1-1, 1-2, and 1-3, the distal tip 100a of the tube 115 of the guidewire 100 is generally partially or completely closed, although this is not required. The distal tip 100a of the tube 115 may be closed in a variety of configurations, including, but not limited to, a) forming the distal tip 100a at least partially from a solid metal, b) soldering or welding the ends of the tube, or c) squeezing or clamping the ends or ends of the tube closed. The distal tip 100a may optionally be smooth and / or rounded and / or tapered.

[0102] The distal portion 101A of the tube 115 of the wire 100 may optionally include a break and gap 103 configured to increase the flexibility of the distal portion 101A of the diagnostic guidewire tube. In one non-limiting configuration, the distal portion of the guidewire may optionally be formed of a solid core with a distal break and gap 103. In other non-limiting configurations, the distal portion of the guidewire may partially or completely include a cavity 117, and the distal break and gap 103 may or may not extend partially or completely through the wall of the tube 115. The distal portion of the tube may be formed of the same or different material as the rest of the tube. The length of the distal end of the tube, including the optional distal discontinuity and gap 103, is generally at least 0.1% (e.g., 0.1-20% and all values ​​and ranges therebetween) of the longitudinal length of the tube.

[0103] Referring again to Figures 1-1, 1-2, and 1-3, 101B represents a region of the tube disposed proximal to the distal portion 101A. The composition of the tube 115 is not limited (e.g., SS, CoCr, Re alloy, Mo alloy, Nitinol, etc.). The diagnostic guidewire body portion as represented by 101B is optionally a hollow tube. Optionally, two or more electrical wires, such as 106a, 106b, are located within the cavity 117 of the diagnostic guidewire tube 115. The hollow tube may partially or completely enclose one or more electrical wires. The configuration of the electrical wires is not limited (e.g., copper, aluminum, etc.). The wires 106a, 106b (represented as disposed within the tubular body) generally extend to and generally beyond the proximal end 100b of the tube and extend to or are electrically connected to the electrical wire connections of the respective sensors 104a, 104b. In one non-limiting configuration, less than 25% (eg, 0.00001-25% and all values ​​and ranges therebetween) of the longitudinal length of the wires 106a, 106b is connected to the tube.

[0104] As depicted in Figures 1-1 and 1-2, the sensors 104a, 104b may optionally be disposed distal to an optional distal discontinuity and gap 103. However, it will be appreciated that when a distal discontinuity and gap 103 is used, the distal discontinuity and gap 103 may extend both proximal and distal to the sensors 104a, 104b, as shown in Figures 1-3. The sensors may be formed from a variety of materials, such as polymers, metals (e.g., copper, aluminum, platinum, titanium, gold, etc.).

[0105] In one non-limiting configuration, the sensors 104a, 104b may be disposed on the tube such that the sensors are at least partially exposed to the outer surface of the guidewire tube. However, it will be appreciated that one or more or all of the sensors may be disposed completely within the cavity 117 of the tube 115. The sensors may be connected to the tube in a variety of configurations (e.g., adhesive, soldering, welding, fusion connection, clamps, magnetic, etc.).

[0106] The tube may optionally include sensor recesses 113 for one or more or all of the sensors such that when one or more or all of the sensors are positioned at least partially on the outer surface of the tube, the upper surfaces of the sensors are positioned flush with or slightly recessed from the outer surface of the tube.

[0107] 1-1, 1-2, and 1-3, the sensors 104a, 104b are spaced apart from the diagnostic guidewire distal portion 101A, although it will be appreciated that one or both of the sensors may be located partially or completely in the diagnostic guidewire distal portion 101A. When one or both sensors are located in a distal region of the tube, the one or both sensors are generally located closer to the guidewire distal tip 100a than to the guidewire proximal end 100b. In one non-limiting configuration, the sensors 104a, 104b are spaced apart from one another by a distance of at least 10 μm (e.g., 10-1000 μm, and all values ​​and ranges therebetween).

[0108] As shown in Figures 1-1, 1-2, and 1-3, the core support wire 107 is optionally disposed within the hollow tube to increase the pushability of the guidewire and facilitate its insertion into the vasculature. The core support wire 107 may be a solid or hollow wire. The core support wire 107 may be formed of a variety of materials (e.g., metals, plastics, ceramics, composites, etc.). In one non-limiting configuration, the core support wire 107 may be formed of a metal such as Nitinol, SS, CoCr, Re alloys, Mo alloys, etc. The cross-sectional area of ​​the core support wire 107 is generally less than the cross-sectional area of ​​the tube cavity over 50-100% of the longitudinal length of the tube cavity (and all values ​​and ranges therebetween). In one non-limiting configuration, the distal region of the core support wire 107 is connected to the tube. In the illustrations of Figures 1-1 and 1-2, the distal tip of the core support wire 107 is connected to the distal portion 101A of the tube, but it will be understood that the core support wire 107 may be connected to other or additional locations on the tube. When the distal portion 101A of the tube is a solid material, the distal tip of the core support wire 107 may be connected to the distal end of the distal portion 101A, but this is not required. As illustrated in Figure 1-3, the core support wire 107 may extend to the distal tip 100a of the tube 115 or to a location quite close to the distal end 100a. The connection structure between the distal portion 101A of the tube and the core support wire 107 is not limited (e.g., friction joint, clamp connection, soldering, adhesive bonding, etc.). In one non-limiting configuration, less than 25% (e.g., 0.00001-25% and all values ​​and ranges therebetween) of the longitudinal length of the core support wire 107 is connected to the tube. In another non-limiting configuration, only the front end or a portion of the front end of the core support wire 107 is connected to the tube.

[0109] As shown in FIGS. 1-1 and 1-2, one or more marker bands 102, 105 may optionally be placed on the guidewire tube to be visualized under angiography to facilitate proper positioning of the guidewire within the vasculature. The distal tip marker band 102 (when used) aids the physician in locating the location of the tip or distal region of the guidewire as the guidewire is being inserted into the vasculature. The sensor marker band 105 (when used) aids the physician in locating the location of the sensors 104a, 104b within the vasculature as the guidewire is being inserted into the vasculature. As can be appreciated, only one marker band may be used or more than two marker bands may be used. While in the illustrations of FIGS. 1-1 and 1-2, one marker band is placed between two of the sensors, it can be appreciated that the marker bands may be placed in other locations (e.g., one on either side of each of one sensors, one on either side of a pair or set of sensors, distal to a sensor, at the location of one or more sensors). The location of the one or more marker bands on the guidewire is not limited. Generally, the one or more marker bands are located at a distal region of the guidewire. Generally, the marker bands are located at a distance of 0.01 to 25% of the longitudinal length of the tube (and all values ​​and ranges therebetween). The material used to form the marker bands is not limited. Generally, the marker material is a different material than the material used to form the tube. As can be appreciated, one or more marker bands may optionally be included on the guidewire shown in Figures 1-3 (e.g., marker band locations similar to Figure 1-1).

[0110] 3, the guidewire may optionally include a noise sensor 120 that reduces or cancels noise received from the sensors 104a, 104b. The noise sensor 120 is connected to an electrical wire 122. The electrical wire 122, like the electrical wires 106a, 106b, extends through the cavity of the tube to the proximal end 100b of the guidewire 100. The electrical wire 122 may be the same as or similar to the wires 106a, 106b, etc., as previously described. In one non-limiting configuration, less than 25% (e.g., 0.00001-25%, and all values ​​and ranges therebetween) of the longitudinal length of the wire 122 is connected to the tube. Generally, the noise sensor 120 is at least partially located on the outer surface of the tube, although it will be understood that the noise sensor 120 may be located within the cavity of the tube. When the noise sensor 120 is located on the outer surface of the tube, the noise sensor 120 may optionally be at least partially located in the sensor recess 113, and the top surface of the noise sensor 120 may optionally be flush with or recessed from the top surface of the tube. As shown in FIG. 1-3, the noise sensor 120 is located distal to the sensors 104a, 104b. In general, the noise sensor 120 is generally located within 0.01-20 cm (and all values ​​and ranges therebetween). The noise sensor 120 is generally located at the distal portion of the tube (e.g., 0.01 to 15% of the longitudinal length of the tube from the distal end of the tube, and all values ​​and ranges therebetween). The noise sensor 120 may be the same as or similar to the sensors 104a, 104b.

[0111] 1-4 and 1-5 show the sensors 104a, 104b located on an optional substrate 110. The substrate is used as a mounting surface for one or more sensors. The one or more sensors may be fixed to the substrate by various structures (e.g., adhesive, fusion connection, soldering, friction fit, hook and loop fastener, etc.). Conductive metal 109a, 109b (e.g., bare wire, coated and / or insulated wire, etc.) may be optionally located on the outer surface of the substrate 110 and / or within the substrate 110. Connection pads 108a, 108b may be optionally located on the outer surface of the substrate 110 and / or within the substrate 110. The connection pads 108a, 108b form a connection between the conductive metal 109a, 109b of the sensors 104a, 104b and the electrical wires 106a, 106b. As can be appreciated, the connection pads 108a, 108b may be removed and some other type of electrical connection (e.g., solder connection, coupler, etc.) between the conductive metal 109a, 109b of the sensor 104a, 104b and the electrical wires 106a, 106b may be used. The substrate 110 (when used) is generally formed of a low or non-conductive material (e.g., polymer, plastic, foam, rubber, ceramic, composite, etc.). In one non-limiting embodiment, the substrate includes a cross-sectional shape that is the same as or similar to the cross-sectional shape of the cavity of the tube. In a non-limiting configuration, the substrate has a generally cylindrical shape. The length of the substrate (when used) is generally about 0.1-25% of the longitudinal length of the tube (and all values ​​and ranges therebetween), and typically the length of the substrate is about 0.1-5% of the longitudinal length of the tube. Generally, the substrate is located at a distance of 0.01 to 25% (and all values ​​and ranges therebetween) of the longitudinal length of the tube from the distal end of the tube, and typically, the substrate is located at a distance of 0.01 to 5% of the longitudinal length of the tube from the distal end of the tube. The substrate may be secured, at least in part, within the cavity of the tube by various configurations (e.g., adhesive, fusion connection, soldering, friction fit, hook and loop fasteners, etc.).

[0112] The substrate 110 may optionally include a cut or milled area 111 such that when the sensor is connected to the cut or milled area 111 and the substrate is secured within the cavity of the tube, the upper surface of the sensor is flush with or recessed from the outer surface of the tube.

[0113] In one non-limiting configuration, the substrate 110 may have a length of at least 50 μm (e.g., 50-5000 μm and all values ​​and ranges therebetween) and a maximum width or diameter of at least 20 μm (e.g., 20-500 μm and all values ​​and ranges therebetween). In another non-limiting configuration, the sensors located on the substrate 110 are separated from each other by at least 10 μm (e.g., 10-1000 μm and all values ​​and ranges therebetween). The sensors may be positioned along a central axis of the substrate, but this is not required. As shown in FIGS. 1-3, the sensors are spaced apart from the proximal and distal ends of the substrate. The connection pads 108a, 108b are depicted as being spaced apart from each other and from the proximal and distal ends of the substrate. The connection pads 108a, 108b are also depicted as being spaced apart from the cut or skived region 111, but this is not required. The connection pads 108a, 108b and / or conductive metal 109a, 109b (eg, wires, etc.) may be located on an outer surface of the substrate 110, or may be located partially or completely within the substrate.

[0114] 1-4, the tube may optionally include a sensor cutout region 119. The length of the optional cutout region 119 (when used) is generally about 0.1-25% (and all values ​​and ranges therebetween) of the longitudinal length of the tube, typically the length of the cutout region 119 is about 0.1-5% of the longitudinal length of the tube. In one non-limiting configuration, when the guidewire includes a substrate 110, the length of the substrate is generally equal to or greater than the length of the cutout region 119 to facilitate fixation of the substrate within the tube. Generally, the cutout region 119 is located at a distance of 0.01 to 25% (and all values ​​and ranges therebetween) of the longitudinal length of the tube from the distal end of the tube, typically the cutout region is located at a distance of 0.01 to 5% of the longitudinal length of the tube from the distal end of the tube. The maximum circumference of the cutout area 119 is generally less than 90% (e.g., 1-90% and all values ​​and ranges therebetween) of the circumference of the tube, and typically the maximum circumference of the cutout location is generally 5-50% of the circumference of the tube.

[0115] The cutout area 119 allows the sensors 104a, 104b disposed on the substrate to be in close proximity to or in direct contact with the thrombus 301 when the guidewire is inserted into the vasculature to measure the precise and accurate impedance of the thrombus, as shown in FIG. 3. The substrate 110 may be customized by varying the placement of the sensors 104a, 104b on the substrate. The sensors may optionally be connected at one end to the conductive metal 109a, 109b, the other end of which may be connected to the connection pads 108a, 108b. Additionally, the connection pads 108a, 108b may be used to electrically connect the conductive material to the electrical wires 106a, 106b. As can be appreciated, the electrical wires 106a, 106b may be directly connected to the sensors. The sensors, conductive material, and / or connection pads may optionally be connected to the inner surface of the guidewire using an adhesive (e.g., epoxy resin, etc.). As can be appreciated, the sensors, conductive material, and / or connection pads may optionally be connected to the inner surface of the guidewire by other structures (eg, soldering, mechanical bonding, etc.).

[0116] As shown in Figures 1-3, 2-1 and 2-2, the electrical wires 106a, 106b are connected to the sensors 104a, 104b via the connection pads 108a, 108b and the conductive metals 109a, 109b. Moreover, the wires 106a, 106b extend into the cavity of the guidewire tube toward the proximal end 100b of the guidewire 100. The free ends 201 of the electrical wires 106a, 106b located at or near the proximal end 100b of the guidewire tube may be optionally attached to a wire connector 203. The use of the wire connector 203 facilitates the disconnection and reconnection of the free ends 201 of the electrical wires 106a, 106b and the free end 202 of the wire 202a, which is connected to the impedance analyzer 204, at the wires 106a, 106b. Similarly, the use of wire connector 203 facilitates the separation and reconnection of free end 201 of electrical wire 122 and free end 124 of wire 122, which is connected to impedance analyzer 204, as shown in FIGs. 1-3. As can be appreciated, free end 201 of electrical wires 106a, 106b and / or free end 124 of wire 122 may be directly connected to impedance analyzer 204. Free end 201, electrical wires 106a, 106b and / or wire 122 may be designed to be as short in length as possible to ensure ease of use of the guidewire. In determining an ideal mechanical thrombectomy method, free end 201 of electrical wires 106a, 106b and / or wire 122 may be separated from wire connector 203 to facilitate insertion of a guidewire into the vasculature, but this is not required. Once the guidewire is inserted into the desired location within the vasculature, the free ends 201 of the electrical lines 106a, 106b and / or lines 122 may again be attached to wire connectors 203 such that the guidewire is electrically connected to an impedance analyzer 204.

[0117] Platinum, titanium, and gold are recommended materials for some or all of the sensors 104a, 104b, 120, although the sensors are not limited to these materials. The materials of the conductive metal 109a, 109b and the connection pads 108a, 108b may include and / or be generally the same materials used to form the sensors 104a, 104b, although this is not required. The optional substrate 110 (which may optionally be soft) may be formed partially or completely of a polymer (e.g., polyimide, parylene-C, etc.). One or more electrical traces 106a, 106b, 122 may be formed of copper (e.g., copper C101, copper C110, etc.), although other conductive materials may be used. The traces and / or the conductive metal and / or the connection pads may be partially or completely coated with a low conductive material or a non-conductive material (e.g., plastic, polymer, etc.).

[0118] Table 1 represents non-limiting examples of materials that may be used in the various components of the medical device, although it will be understood that other equivalent materials may be used, and Table 1 represents non-limiting parameters of the components on the medical device, although it will be understood that other parameters may be used. [Table 1]

[0119] 1-3, 2-1 and 2-2, when the guidewire is properly positioned within the vasculature, the sensors 104a, 104b are in direct contact with the thrombus 301 as shown in FIG. 3 and a signal from the electrical current interacting with the thrombus 301 is sent from the sensors 104a and / or 104b through the electrical wires 106a and / or 106b to the impedance analyzer 204.

[0120] 1-3 and 12, when the guidewire includes a noise sensor 12, one or both signals from the sensor 104a and / or 104b may be passed through an electronic circuit 150 (e.g., a differential amplifier, an amplifier noise remover, a current source, a current sensing source, etc.) and processed to facilitate noise removal. Furthermore, the signals from the sensor 120 and 104a and / or 104b may be processed in an impedance analyzer 204. As shown in FIG. 1-3 and FIG. 12, the medical guidewire is connected to a differential amplifier 150 and a current source and / or a current sensing source that may be used in an electrical impedance measurement system having a differential amplifier 150 for the medical guidewire. The input signal from the analyzer 204 is introduced into the circuit via a single-ended electrical line to the transmitting sensor 104b. The transmitting sensor 104b transmits a signal through the tissue and is picked up by the receiving sensor 104a. The signal from the receiving sensor 104a and also the optional input sigma are amplified by the differential amplifier 150. Upon analysis, the analyzed signal may optionally be filtered from noise and / or offset with its high common mode rejection capability. After signal amplification, the processed signal is converted to a single-ended signal and the converted output signal is sent to the analyzer 204.

[0121] For clarity, Figures 1-1, 1-2, 1-3, 2-1, 2-2, and 3 depict a guidewire having an arrangement of two electrical sensors 104a, 104b, although it will be understood that the guidewire may include more than two sensors.

[0122] FIG. 2-1 shows the free ends 201 of the electrical wires 106a, 106b connected to the end 202 of the wire 202a to form a closed configuration between the guidewire and the impedance analyzer 204. When the wire connector 203 is closed, the circuit forms a closed loop and the impedance analyzer 204 can read the impedance of the thrombus detected by the sensor on the guidewire. The wire connector may optionally include one or more conductive pads 205, and one or more conductive pads 206 are used to allow electrical signals to pass between the electrical wires 106a, 106b and the wire 202a. A similar connection structure including an additional wire 122 is shown in FIG. 3.

[0123] FIG. 2-2 shows electrical lines 106a, 106b and line 202 in an open configuration. When wire connector 203 is opened, electrical lines 106a, 106b can be electrically disconnected from impedance analyzer 204 and the impedance of the thrombus cannot be measured. As can be appreciated, such a disconnect structure may be used for line 122 shown in FIGS. 1-3. The ability to disconnect the guidewire from impedance analyzer 204 ensures that a mechanical thrombectomy device can easily pass over the guidewire.

[0124] The signals from the sensors 104a, 104b may be captured, converted, and analyzed using an impedance analyzer 204, and the information from the impedance analyzer 204 may be used to aid in determining a treatment for a thrombus in the vasculature. Optional electronic circuitry 150 (e.g., differential amplifiers, amplifier noise reducers, etc.) in combination with the use of a noise sensor 120 may be used to help eliminate noise and improve the determination of a treatment for a thrombus in the vasculature.

[0125] FIG. 3 depicts a schematic diagram of an electrical impedance measurement system. An AC power source is used in the impedance analyzer 204. The current direction shown in FIG. 3 is for illustration purposes only. It should be understood that the direction of current flow may change depending on the AC current source used. The signal transmitted through the electrical lines 106a, 106b generally has a maximum allowable voltage drop of about 10% or less (e.g., 0-10%, and all values ​​and ranges therebetween), although this is not required. The impedance analyzer 204 is used to measure the composition and / or other attributes (e.g., density, size, etc.) of the thrombus 301. The parameters of the sensor, such as the size, spacing, and / or placement of the sensor on the guidewire, as well as the area of ​​the connection pads 108a, 108b, may be controlled to read the desired signal associated with the thrombus 301. These parameters may be selected to ensure a low signal-to-noise ratio (SNR) and a more accurate analysis of the thrombus 301.

[0126] Figures 4-1, 4-2, 4-3, and 4-4 represent non-limiting possible circuit models for a two-sensor-on-guidewire configuration. The four possible circuits may be used to simulate the impedance of a thrombus 301 in the vasculature at various degrees of electrical signal. The impedance of the tissue to be measured is modeled by combining resistors 402, 403, 404 and capacitors 405, 407a, 407b, 408a, 408b, 409, 410 in parallel and series. To represent the non-ideal double layer capacitance in real-world situations at the sensor-tissue interface, both the working and counter sensors are considered as Constant Phases Elements 401, 406, which are represented by the following equation:

number

[0127] FIG. 4-2 includes the use of two capacitors 408a, 408b to simulate the double membrane of a cell, and at the same time, adds a CPE 411 to the model to simulate the non-ideal double layer capacitance of tissue in a real-world situation, so that the total impedance is expressed as:

number

[0128] 5-1 and 5-2, the guide 100 according to the present disclosure operates similarly to the solid core guidewires of the prior art, however, the guidewire 100 includes a new additional diagnostic feature that is used to detect / determine one or more attributes of a thrombus 301 within the vasculature. Once the guidewire 100 reaches the site of the thrombus, the guidewire is inserted through the thrombus 301. Optionally, the guidewire can be moved through the thrombus 301 and measured at multiple locations to record the impedance of the thrombus 301 at various portions over a portion or the entire length of the thrombus 301. While such measurement methods may be used to better represent the composition of the entire thrombus as compared to measurements at a single location, it will be appreciated that measurements at only a single location of the thrombus 301 may be used to detect / determine one or more attributes of the thrombus 301 within the vasculature.

[0129] Pre-operative preparation of the guidewire 100 includes attaching the impedance analyzer wire 202a to the impedance analyzer 204 using a standard connector or other type of connector. The impedance analyzer wire 202a may then be attached to the free ends 201 of the electrical wires 106a, 106b, optionally using a wire connector 203. During the procedure, the guidewire 100 may be inserted into the patient's blood vessel 302 using standard guidewire insertion methods. FIGS. 5-1 and 5-2 depict the guidewire 100 positioned inside the blood vessel 302, with two sensors 104a, 104 placed across the stenosis. The impedance analyzer 204 is switched on before, during, or after the guidewire 100 is inserted into the thrombus 301. The guidewire 100 may be pushed through the thrombus 301 and slowly measure the impedance of the thrombus 301 at various locations along the length of the thrombus 301. The impedance of the thrombus 301 may be measured when the thrombus 301 contacts the sensors 104a, 104b of the guidewire 100. When the physician has enough data about the thrombus 301 to determine an appropriate mechanical thrombectomy method, the impedance analyzer 204 is switched off. The wire connector 203 may then be optionally opened and the electrical wires 106a, 106b may be disconnected from the wire connector 203 before performing a mechanical thrombectomy procedure to treat the thrombus 301.

[0130] FIG. 5-2 depicts another configuration of the guidewire 100 disposed inside the blood vessel 302. The guidewire 100 includes two sensors 501, 502 that are placed across the thrombus 301. The two sensors are formed as a band that substantially or completely circumscribes the body of the guidewire 100. The shape of the one or more sensors is not limited. As shown in FIG. 5-2, the sensors have the shape of an annular band. In the one shown in FIG. 5-1, the sensors 104a, 104b have a square or rectangular shape that does not substantially circumscribe the outer surface of the guidewire.

[0131] 6-1, 6-2, and 7 are alternative configurations of electrical wires for guidewire 100. FIGS. 6-1 and 6-2 depict an embodiment of diagnostic guidewire 100 that does not have a solid core support wire 107. When the pushability of guidewire 100 is sufficient for guidewire 100 to reach the thrombus site without the need for support wire 107, solid core support wire 107 may be removed. Such removal increases lumen space for adding sensors to guidewire 100 and allows for greater surface coverage of the guidewire with sensors, thus obtaining a more comprehensive analysis of thrombus 301.

[0132] In contrast to FIG. 1-1, FIG. 7 depicts an isometric view of one electrical wire (e.g., 106b) replaced by a solid core support wire 701 inside diagnostic guidewire 100. Solid core support wire 701 may optionally have a dual function. Support wire 701 may be used to conduct electrical signals to / from one or more sensors and / or provide additional support to the guidewire compared to standard electrical wire 106b in guidewire 100 (e.g., similar function to solid core support wire 107). Solid core support wire 701 may have a higher density, larger cross-sectional area, and / or higher stiffness than the material used to form electrical wires 106a, 106b.

[0133] 8, 9-1 and 9-2, two non-limiting variations of application of the diagnostic device according to the present disclosure are shown. Instead of using a guidewire 100, the sensor may be placed on a stent retriever, an inflatable balloon or a catheter.

[0134] Referring now to FIG. 8, a stent retriever 804 is shown. The operation and use of stent retrievers are known in the art and therefore will not be described here. The stent retriever is depicted as including a number of connecting wires 805 that are connected to one another and a distal end is connected to a retriever wire 806 that is used to move the stent retriever within the blood vessel. The stent retriever is depicted as including a number of sensors. In one non-limiting configuration, the stent retriever includes four sensors, namely 802a, 802b, 802c, and 802d. As can be appreciated, the stent retriever may include more than four sensors or less than four sensors (e.g., 2-20 sensors and all values ​​and ranges therebetween). The location of the sensors on the stent retriever is not limited. In the one shown in FIG. 8, the sensors are positioned away from one another and one or more or all of the sensors are positioned away from the end of the stent retriever.

[0135] The stent retriever is also depicted as including one or more optional distal marker bands 801a, 801b, 801c located at the distal tip or distal region of the stent retriever. One of many distal markers is used to locate the stent retriever within the vessel during angiography. The material used to form the distal mark bands may be the same as or similar to the material used to form the marker band 105 as described above. As shown in FIG. 8, additional sensor marker bands 803a, 803b, 803c, 803d may be optionally located in close proximity (e.g., less than 20 μm) from one or more sensors 802a, 802b, 802c, 802d to help identify the location of the sensor within the vessel during angiography. The locations and number of sensors 802a, 802b, 802c, 802d, sensor marker bands 803a, 803b, 803c, 803d, and marker bands 801a, 801b, 801c for the vasculature are not limited to the configuration shown in Figure 8. The stent-receiver configuration shown in Figure 8 may be used to identify the composition and attributes of thrombus 301, and lesions and tissues.

[0136] 9-1 and 9-2, there is shown a balloon guidewire 906 including multiple sensors 903a, 903b thereon. Features such as optional distal marker band 901, optional distal tip notch 902, optional sensor marker band 904, and electrical lines 905a, 905b are similar in function to the marker bands 102, 105, distal notch and gap 103, and lines 106a, 106b of the guidewire 100 shown in FIGS. 1-1 and 1-2, and therefore the details of these features will not be repeated here.

[0137] 9-1 and 9-2 show a balloon guidewire 906 having two sensors 903a, 903b mounted on a soft substrate 908 so that the sensors 903a, 903b can directly contact the thrombus 301 when the soft substrate is partially or fully expanded (e.g., inflated) or before expansion. The two sensors 903a, 903b shown in FIG. 9-1 are disposed on the outer surface of the soft substrate 908. The number and location of the sensors 903a, 903b and the one or more marker bands 901, 904 are not limited to the locations shown in FIG. 9-1 and 9-2. In general, two or more sensors are disposed on the soft substrate 908. When used, the one or more marker bands may be disposed at or near the proximal and / or distal end of the soft substrate 908 and / or disposed on the soft substrate 908. As shown in Figures 9-1 and 9-2, the marker band 904 is disposed on the soft substrate 908 and between the sensors 903a, 903b. The locations of the sensors 903a, 903b and the one or more marker bands are not limited to the locations shown in Figures 9-1 and 9-2. The balloon guidewire configuration depicted in Figures 9-1 and 9-2 may be used to identify the composition and attributes of the thrombus 301 and the lesion and tissue.

[0138] 10-1, 10-2, 10-3, and 10-4, additional embodiments of multiple sensors used on the guidewire 100 are shown. FIG. 10-1 illustrates another design using four sensors 1001a, 1001b, 1001c, and 1001d on the guidewire 100. FIG. 10-2 and 10-3 illustrate another design using six sensors 1006a, 1006b, 1006c, 1006d, 1006e, and 1006f on the guidewire 100. FIG. 10-3 and 10-4 illustrate vertical and horizontal cross-sectional views of non-limiting sensor placements in a six sensor configuration. As can be appreciated, other numbers of sensors on the guidewire 100 or on other types of devices as previously described (e.g., stent retrievers, balloon guidewires, etc.) may be used. Additionally, the orientation of the sensors on the guidewire 100 or on other types of devices as previously described is not limited. As can be appreciated, as the number of sensors on guidewire 100, or on other types of devices discussed above, increases, the number of electrical wires and / or solid core support wires 701 may also be increased, but this is not required. In the example shown in FIG. 10-1, one set of sensors 1001a and 1001b are connected to wire 1003a, and sensors 1001c and 1001d are connected to wire 1003b. In this configuration, one or more sensors are connected to one wire and one or more other sensors are connected to the other wire, such that one set of sensors is connected to a single wire that extends to the distal end of the guidewire, and the other set of sensors is connected to the other single wire that extends to the distal end of the guidewire.

[0139] Features such as sensor marker bands 1002, 1007, conductive metal 1003a, 1003b, connection pads 1004a, 1004b, and electrical lines 1005a, 1005b are similar in function to the marker bands 102, 105, distal break and gap 103, and lines 106a, 106b of the guidewire 100 shown in Figures 1-1 and 1-2, and therefore details of these features will not be repeated here.

[0140] When more than two sensors are used on a guidewire, the sensors may be used to cover a larger surface area of ​​the guidewire 100 or other types of devices described above, and such additional information from the use of additional sensors may be available, potentially shortening processing time as the physician may not need to measure multiple points to obtain the overall impedance of the thrombus 301.

[0141] FIG. 11 depicts other features in which guidewire 100 may be used. The guidewire of FIG. 11 is similar to the guidewire shown in FIGS. 1-1 and 1-2, and similar features of the guidewire will not be repeated here. The outer surface of tube 115 includes an opening 121 configured to allow a wire from a sensor to enter the cavity of the tube. The location of opening 121 on the tube is not limited. In the illustration of FIG. 11, opening 121 is spaced from the sensor, but it will be understood that opening 121 may be located below one or more sensors.

[0142] A solid core 140 is depicted as being located within the cavity 117 of the tube 115. The solid core 140 may be a substitute for the core support wire 107 as shown in FIG. 1-1. The solid core 140 may be used to replace one of the wires 106a or 106b, but this is not required. In such a construction, the solid core is formed of a conductive material. As shown in FIG. 11, the wire within the cavity of the tube is disposed between the outer surface of the core support wire 107 and the inner surface of the tube. The core may optionally be fixed at one or more locations within the cavity of the tube, but this is not required. In one non-limiting construction, 1-99.9% (and all values ​​and all ranges therebetween) of the longitudinal length of the tapered distal tip 130 is not connected to the cavity of the tube. As shown in FIG. 11, the cross-sectional area of ​​the solid core 140 is greater than the cross-sectional area of ​​the core support wire 107 as shown in FIG. 1-1. In one non-limiting embodiment, the cross-sectional area of ​​the solid core 140 is 20-95% (and all values ​​and ranges therebetween) of the cross-sectional area of ​​the tube's cavity. The solid core 140 may be configured to extend to the distal end of the tube, but this is not required. In general, the material used to form the solid core 140 may be the same as or different from the material used to form the tube.

[0143] The guidewire distal section 101A includes a tapered distal tip 130. The shape of the tapered distal tip 130 is not limited (e.g., conical, pyramidal, one-sided tapered or angled, etc.). The tapered distal tip 130 may be used to facilitate maneuvering and / or insertion of the guidewire 100 through a patient's vascular system.

[0144] As shown in FIG. 11, the proximal end region of the solid core 140 forms a tapered distal tip 130, although this is not required. The tapered distal tip of the guidewire distal section 101A may be formed by casting, grinding, scraping, etching, etc. Alternatively, the tapered distal tip 130 may optionally be formed of a soft material (e.g., a polymer, etc.) that is cast or otherwise formed. Such a polymer distal tip may be connected to the end of the guidewire using adhesives, fusion connections, clamps, etc. The length and shape of the tapered distal tip 130 are not limited. Generally, the length of the tapered distal tip 130 is 0.05-8 cm (and all values ​​and ranges therebetween). The tapered distal tip may optionally include a coating 132 that can be used for movement and / or insertion of the guidewire 100 through the vascular system of a patient. The coating may be a polymeric material and / or a metallic material. Generally, the coating is formed of a different material that is used to form the tapered distal tip. Coating 132 (when used) may optionally include a radiopaque material to facilitate identification and / or placement of the distal portion of guidewire 100 as the guidewire is moved through the patient's vascular system. The thickness of the coating is not limited. Generally, the thickness of the coating is less than 2 mm (e.g., 1 μm to 2 mm, and all values ​​and ranges therebetween). Alternatively, the optional radiopaque material may be in the form of a coiled shape around the distal portion of the guidewire and / or may be a plated or coated material on the distal portion of the guidewire. As can be appreciated, the coiled shape (when used) need not be formed of a radiopaque material. As can be appreciated, the use of tapered distal tip 130, optional coating 132, and optional radiopaque material may be used with any of the guidewires described above.

[0145] 13, there is shown an optional attachment mechanism for connecting the wires (e.g., wires 106a, 106b, 112, etc.) to wire connector 203 or other type of wire connector. Electrical wires are optionally connected to a mating portion of the attachment mechanism, which is optionally metallized, to ensure a good connection to provide power and allow the sensors to collect data. The attachment mechanism includes two mating positions arranged in a manner that prevents the physician from attaching the parts incorrectly, although it will be understood that other types and numbers of mating connections may be used. Knobs on the mating connections help to lock the parts together, along with grooves that limit any rotational movement applied during the procedure.

[0146] In the various embodiments described herein, a single component may be replaced with multiple components and multiple components may be replaced with a single component to perform a given function or functions, and unless such substitution would result in an ineffective implementation, such substitution is within the intended scope of the embodiments.

[0147] Additional features of the empirically placed device and method of operation are included in the figures.

[0148] A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the scope and spirit of the claims. Accordingly, other implementations are within the scope of the following claims.

[0149] Disclosed are materials, systems, devices, methods, compositions, and components that can be used in, can be used in the preparation of, or are products of the disclosed methods, systems, and devices. These and other components are disclosed herein, and when combinations, subsets, interactions, groups, etc. of these components are disclosed, it is understood that each specific relationship to the various individual and collective combinations and permutations of these components may not be explicitly disclosed, but each is expressly contemplated and described herein. For example, when a device is disclosed and discussed, each and every combination and permutation and possible variation of the device is expressly contemplated, unless expressly indicated to the contrary. Likewise, any subset or combination of these is also expressly contemplated and described. This concept applies to all aspects of this disclosure, including, but not limited to, steps in methods using the disclosed systems or devices. Thus, where there are various additional procedures that may be performed, it is understood that each of these additional procedures may be performed with any particular method step or combination of method steps of the disclosed methods, and that each such combination or subset of combinations is expressly contemplated and should be considered as disclosed.

[0150] In order to assist the Patent Office, and any reader of this application and any resulting patent, in interpreting the claims appended hereto, Applicants do not intend that 35 U.S.C. 112(f) apply to any of the appended claims, or claim elements, unless the terms "means" or "step" are expressly used in an individual claim.

[0151] (Additional Note) (Appendix 1) a medical device configured for insertion into a blood vessel of an animal or human, the medical device including a distal portion having a distal end and a proximal portion having a proximal end; an electrical assembly disposed at least partially on the distal portion of the medical device, the electrical assembly including a first sensor and a second sensor disposed on the distal portion of the medical device, the electrical assembly configured to transmit and receive one or more electrical signals at a diagnostic site when the distal portion of the medical device is positioned at the diagnostic site; an impedance analyzer configured to analyze one or more of the electrical signals received from the electrical assembly; A medical diagnostic system comprising:

[0152] (Appendix 2) The medical device is selected from the group consisting of a guidewire, a balloon guidewire, a stent retriever, or a catheter. 2. The medical diagnostic system of claim 1.

[0153] (Appendix 3) the medical device includes a radiopaque marker located a) proximate to one of the first sensor or the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. 2. The medical diagnostic system of claim 1.

[0154] (Appendix 4) the medical device includes a radiopaque marker located a) proximate to one of the first sensor or the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. 3. A medical diagnostic system as described in claim 2.

[0155] (Appendix 5) the electrical assembly includes a noise reduction sensor located at the distal portion of the medical device, the noise reduction sensor being spaced apart from the first sensor and the second sensor, the noise reduction sensor being located a) proximal to one of the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to one of the first sensor and the second sensor. 2. The medical diagnostic system of claim 1.

[0156] (Appendix 6) the electrical assembly includes a noise reduction sensor located at the distal portion of the medical device, the noise reduction sensor being spaced apart from the first sensor and the second sensor, the noise reduction sensor being located a) proximal to one of the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to one of the first sensor and the second sensor. 5. A medical diagnostic system according to any one of appendices 2-4.

[0157] (Appendix 7) further comprising an electronic circuit selected from the group consisting of a differential amplifier and an amplifier noise remover. 2. The medical diagnostic system of claim 1.

[0158] (Appendix 8) further comprising an electronic circuit selected from the group consisting of a differential amplifier and an amplifier noise remover. 7. The medical diagnostic system of claim 2,

[0159] (Appendix 9) the first sensor and / or the second sensor are exposed on an outer surface of the medical device such that at least a portion of the first sensor and / or the second sensor can contact an inner wall of the blood vessel or a substance disposed on the inner wall of the blood vessel when the distal portion of the medical device is located at the diagnostic site. 2. The medical diagnostic system of claim 1.

[0160] (Appendix 10) the first sensor and / or the second sensor are exposed on an outer surface of the medical device such that at least a portion of the first sensor and / or the second sensor can contact an inner wall of the blood vessel or a substance disposed on the inner wall of the blood vessel when the distal portion of the medical device is located at the diagnostic site. 9. A medical diagnostic system according to any one of appendices 2-8.

[0161] (Appendix 11) The medical device includes a tube, an outer surface of the tube including a first sensor recess and a second sensor recess, the first sensor recess configured to at least partially receive the first sensor, the second sensor recess configured to at least partially receive the second sensor, a top surface of the first sensor being flush or recessed with the outer surface of the tube when the first sensor is located in the first sensor recess, and a top surface of the second sensor being flush or recessed with the outer surface of the tube when the second sensor is located in the second sensor recess. 10. The medical diagnostic system of claim 9.

[0162] (Appendix 12) The medical device includes a tube, an outer surface of the tube including a first sensor recess and a second sensor recess, the first sensor recess configured to at least partially receive the first sensor, the second sensor recess configured to at least partially receive the second sensor, a top surface of the first sensor being flush or recessed with the outer surface of the tube when the first sensor is located in the first sensor recess, and a top surface of the second sensor being flush or recessed with the outer surface of the tube when the second sensor is located in the second sensor recess. 11. The medical diagnostic system of claim 10.

[0163] (Appendix 13) the medical device includes a tube including an internal cavity, the internal cavity extending at least 3% of a longitudinal length of the tube, the electrical assembly including a first wire electrically connected to the first sensor and a second wire electrically connected to the second sensor, the first wire and the second wire being located within at least 10% of a longitudinal length of the cavity of the tube; 2. The medical diagnostic system of claim 1.

[0164] (Appendix 14) the medical device includes a tube including an internal cavity, the internal cavity extending at least 3% of a longitudinal length of the tube, the electrical assembly including a first wire electrically connected to the first sensor and a second wire electrically connected to the second sensor, the first wire and the second wire being located within at least 10% of a longitudinal length of the cavity of the tube; 13. A medical diagnostic system according to any one of claims 2-12.

[0165] (Appendix 15) A majority of the longitudinal length of the first wire and the second wire disposed within the cavity is not connected to the cavity. 14. The medical diagnostic system of claim 13.

[0166] (Appendix 16) A majority of the longitudinal length of the first wire and the second wire disposed within the cavity is not connected to the cavity. 15. The medical diagnostic system of claim 14.

[0167] (Appendix 17) a distal portion of the medical device includes one or more recesses or cutouts configured to increase flexibility of the distal portion of the medical device, the one or more recesses or cutouts being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor; 2. The medical diagnostic system of claim 1.

[0168] (Appendix 18) a distal portion of the medical device includes one or more recesses or cutouts configured to increase flexibility of the distal portion of the medical device, the one or more recesses or cutouts being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor; 17. The medical diagnostic system of claim 2-16.

[0169] (Appendix 19) the medical device includes a rod located within the cavity of the tube and extending from a proximal end of the tube to a distal portion of the tube, the majority of the length of the rod being unconnected to the cavity; 14. The medical diagnostic system of claim 13.

[0170] (Appendix 20) the medical device includes a rod located within the cavity of the tube and extending from a proximal end of the tube to a distal portion of the tube, the majority of the length of the rod being unconnected to the cavity; 19. The medical diagnostic system of any one of claims 14-18.

[0171] (Appendix 21) the medical device includes a tube substrate, the first sensor and the second sensor being coupled to a top surface of the tube substrate; 2. The medical diagnostic system of claim 1.

[0172] (Appendix 22) the medical device includes a tube substrate, the first sensor and the second sensor being coupled to a top surface of the tube substrate; 21. A medical diagnostic system according to any one of claims 2-20.

[0173] (Appendix 23) the tube substrate includes a skived region that reduces a cross-sectional area of ​​the skived region relative to regions of the tube substrate disposed proximal and / or distal to the skived region, and the first sensor and the second sensor are at least partially located on the skived region. 22. The medical diagnostic system of claim 21.

[0174] (Appendix 24) the tube substrate includes a skived region that reduces a cross-sectional area of ​​the skived region relative to regions of the tube substrate disposed proximal and / or distal to the skived region, and the first sensor and the second sensor are at least partially located on the skived region. 23. The medical diagnostic system of claim 22.

[0175] (Appendix 25) the tube substrate has a longitudinal length that is 1-25% of the longitudinal length of the body or tube of the medical device, and the tube substrate has a cross-sectional shape that is the same as or similar to a) the cross-sectional shape of the cavity of the tube, or b) a spatial region in the body; 22. The medical diagnostic system of claim 21.

[0176] (Appendix 26) the tube substrate has a longitudinal length that is 1-25% of the longitudinal length of the body or tube of the medical device, and the tube substrate has a cross-sectional shape that is the same as or similar to a) the cross-sectional shape of the cavity of the tube, or b) a spatial region in the body; 25. The medical diagnostic system of claim 22.

[0177] (Appendix 27) the medical device includes a body or tube, the body or tube including a cutout region located at a distal portion of the body or tube, and the tube substrate is positioned within the cavity and oriented relative to the cutout region such that top surfaces of the first sensor and the second sensor connected to the top surface of the tube substrate are exposed to an exterior surface of the medical device. 22. The medical diagnostic system of claim 21.

[0178] (Appendix 28) the medical device includes a body or tube, the body or tube including a cutout region located at a distal portion of the body or tube, and the tube substrate is positioned within the cavity and oriented relative to the cutout region such that top surfaces of the first sensor and the second sensor connected to the top surface of the tube substrate are exposed to an exterior surface of the medical device. 27. The medical diagnostic system of claim 22.

[0179] (Appendix 29) the medical device is a balloon guidewire, the balloon guidewire including a tube and an inflatable balloon, the outer surface of the balloon including the first sensor and the second sensor; 3. A medical diagnostic system as described in claim 2.

[0180] (Appendix 30) the medical device is a balloon guidewire, the balloon guidewire including a tube and an inflatable balloon, the outer surface of the balloon including the first sensor and the second sensor; 31. The medical diagnostic system of claim 3-28.

[0181] (Appendix 31) the medical device is a stent retriever, the stent retriever including a plurality of interconnected wires, the first sensor and the second sensor being connected to an outer surface of the interconnected wires. 3. A medical diagnostic system as described in claim 2.

[0182] (Appendix 32) the medical device is a stent retriever, the stent retriever including a plurality of interconnected wires, the first sensor and the second sensor being connected to an outer surface of the interconnected wires. 11. The medical diagnostic system according to any one of appendices 3-10.

[0183] (Appendix 33) the distal portion of the medical device comprises a tapered region. 2. The medical diagnostic system of claim 1.

[0184] (Appendix 34) the distal portion of the medical device comprises a tapered region. 31. The medical diagnostic system of claim 2.

[0185] (Appendix 35) the tapered region of the distal section being at least partially coated with a radiopaque material; 34. The medical diagnostic system of claim 33.

[0186] (Appendix 36) the tapered region of the distal section being at least partially coated with a radiopaque material; 35. The medical diagnostic system of claim 34.

[0187] (Appendix 37) A method of using the medical diagnostic system described in Appendix 1 to a) obtain one or more attributes of a thrombus in a blood vessel, and / or b) identify the presence or existence of cancer cells flowing in a blood vessel.

[0188] (Appendix 38) A method of using the medical diagnostic system described in any one of claims 2-36 to a) obtain one or more attributes of a thrombus in a blood vessel, and / or b) identify the presence or existence of cancer cells flowing in a blood vessel.

[0189] (Appendix 39) 1. A medical device configured to be inserted into a blood vessel of an animal or human, the medical device comprising: a tube and an electrical assembly, the tube comprising an internal cavity extending at least 3% of a longitudinal length of the tube, the tube having a distal portion having a distal end, the tube having a proximal portion having a proximal end, the electrical assembly disposed at least partially in the distal portion of the tube, the electrical assembly comprising a first sensor and a second sensor, the electrical assembly comprising a first wire electrically connected to the first sensor and a second wire electrically connected to the second sensor, the first wire and the second wire being located within at least 10% of a longitudinal length of the cavity of the tube, the first sensor and the second sensor being disposed in the distal portion of the tube, and the electrical assembly configured to transmit and receive one or more electrical signals at a diagnostic site when the distal portion of the tube is disposed at the diagnostic site.

[0190] (Appendix 40) a) proximate one of the first sensor or the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. 40. The medical device of claim 39.

[0191] (Appendix 41) the electrical assembly includes a noise reduction sensor located in the distal portion of the tube, the noise reduction sensor being spaced apart from the first sensor and the second sensor, the noise reduction sensor being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. 40. The medical device of claim 39.

[0192] (Appendix 42) the electrical assembly includes a noise reduction sensor located in the distal portion of the tube, the noise reduction sensor being spaced apart from the first sensor and the second sensor, the noise reduction sensor being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. 41. The medical device of claim 40.

[0193] (Appendix 43) the first sensor or the second sensor is exposed on an outer surface of the tube such that at least a portion of the first sensor or the second sensor can contact an inner wall of a blood vessel or a substance disposed on the inner wall of the blood vessel when the distal portion of the tube is located at the diagnosis site. 40. The medical device of claim 39.

[0194] (Appendix 44) the first sensor or the second sensor is exposed on an outer surface of the tube such that at least a portion of the first sensor or the second sensor can contact an inner wall of a blood vessel or a substance disposed on the inner wall of the blood vessel when the distal portion of the tube is located at the diagnosis site. 43. The medical device of any one of claims 40-42.

[0195] (Appendix 45) an outer surface of the tube including a first sensor recess and a second sensor recess, the first sensor recess configured to at least partially receive the first sensor and the second sensor recess configured to at least partially receive the second sensor, a top surface of the first sensor being flush or recessed with the outer surface of the tube when the first sensor is located in the first sensor recess, and a top surface of the second sensor being flush or recessed with the outer surface of the tube when the second sensor is located in the second sensor recess; 40. The medical device of claim 39.

[0196] (Appendix 46) an outer surface of the tube including a first sensor recess and a second sensor recess, the first sensor recess configured to at least partially receive the first sensor and the second sensor recess configured to at least partially receive the second sensor, a top surface of the first sensor being flush or recessed with the outer surface of the tube when the first sensor is located in the first sensor recess, and a top surface of the second sensor being flush or recessed with the outer surface of the tube when the second sensor is located in the second sensor recess; 45. The medical device of any one of claims 40-44.

[0197] (Appendix 47) A majority of the longitudinal lengths of the first wire and the second wire disposed within the cavity are not connected to the cavity. 40. The medical device of claim 39.

[0198] (Appendix 48) A majority of the longitudinal lengths of the first wire and the second wire disposed within the cavity are not connected to the cavity. 47. The medical device of any one of claims 40-46.

[0199] (Appendix 49) a distal portion of the tube includes one or more depressions or cutouts configured to increase flexibility of the distal portion of the tube, the one or more depressions or cutouts being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. 40. The medical device of claim 39.

[0200] (Appendix 50) a distal portion of the tube includes one or more depressions or cutouts configured to increase flexibility of the distal portion of the tube, the one or more depressions or cutouts being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. 10. The medical device of claim 40.

[0201] (Appendix 51) a rod located within the cavity of the tube and extending from a proximal end of the tube to a distal portion of the tube, the majority of the length of the rod being unconnected to the cavity; 40. The medical device of claim 39.

[0202] (Appendix 52) a rod located within the cavity of the tube and extending from a proximal end of the tube to a distal portion of the tube, the majority of the length of the rod being unconnected to the cavity; 51. The medical device of any one of claims 40-50.

[0203] (Appendix 53) a tube substrate at least partially positioned within the cavity of the tube, the first sensor and the second sensor being coupled to a top surface of the tube substrate, the tube substrate being formed of a different material than the tube. 40. The medical device of claim 39.

[0204] (Appendix 54) a tube substrate at least partially positioned within the cavity of the tube, the first sensor and the second sensor being coupled to a top surface of the tube substrate, the tube substrate being formed of a different material than the tube. 53. The medical device of any one of claims 40-52.

[0205] (Appendix 55) the tube substrate includes a skived region that reduces a cross-sectional area of ​​the skived region relative to regions of the tube substrate disposed proximal and / or distal to the skived region, and the first sensor and the second sensor are at least partially located on the skived region. 54. The medical device of claim 53.

[0206] (Appendix 56) the tube substrate includes a skived region that reduces a cross-sectional area of ​​the skived region relative to regions of the tube substrate disposed proximal and / or distal to the skived region, and the first sensor and the second sensor are at least partially located on the skived region. 55. The medical device of claim 54.

[0207] (Appendix 57) the tube substrate has a longitudinal length that is 1-25% of the longitudinal length of the tube, and the tube substrate has a cross-sectional shape that is the same as or similar to the cross-sectional shape of the cavity of the tube; 54. The medical device of claim 53.

[0208] (Appendix 58) the tube substrate has a longitudinal length that is 1-25% of the longitudinal length of the tube, and the tube substrate has a cross-sectional shape that is the same as or similar to the cross-sectional shape of the cavity of the tube; 7. The medical device of any one of claims 54-56.

[0209] (Appendix 59) the tube includes a cutout region located at the distal portion of the tube, and the tube substrate is located within the cavity and oriented relative to the cutout region such that top surfaces of the first sensor and the second sensor coupled to the top surface of the tube substrate are exposed to an exterior surface of the medical device. 54. The medical device of claim 53.

[0210] (Appendix 60) the tube includes a cutout region located at the distal portion of the tube, and the tube substrate is located within the cavity and oriented relative to the cutout region such that top surfaces of the first sensor and the second sensor connected to the top surface of the tube substrate are exposed to an exterior surface of the medical device. 10. The medical device of any one of claims 54-58.

[0211] (Appendix 61) the distal portion of the tube includes a tapered region; 40. The medical device of claim 39.

[0212] (Appendix 62) the distal portion of the tube includes a tapered region; 61. The medical device of any one of claims 40-60.

[0213] (Appendix 63) the tapered region being coated with a radiopaque material; 62. The medical device of claim 61.

[0214] (Appendix 64) the tapered region being coated with a radiopaque material; 63. The medical device of claim 62.

[0215] (Appendix 65) A method of using the medical device of claim 39 to a) obtain one or more attributes of a thrombus in a blood vessel, and / or b) identify the presence or entity of cancer cells flowing in a blood vessel.

[0216] (Appendix 66) A method of using the medical device described in any one of claims 40-46 to a) obtain one or more attributes of a thrombus in a blood vessel, and / or b) identify the presence or existence of cancer cells flowing in a blood vessel.

Claims

1. a medical device configured for insertion into a blood vessel of an animal or human, the medical device including a distal portion having a distal end and a proximal portion having a proximal end; an electrical assembly disposed at least partially on the distal portion of the medical device, the electrical assembly including a first sensor and a second sensor disposed on the distal portion of the medical device, the electrical assembly configured to transmit and receive one or more electrical signals at a diagnostic site when the distal portion of the medical device is positioned at the diagnostic site; an impedance analyzer configured to analyze one or more of the electrical signals received from the electrical assembly; A medical diagnostic system comprising:

2. The medical device is selected from the group consisting of a guidewire, a balloon guidewire, a stent retriever, or a catheter. The medical diagnostic system of claim 1 .

3. the medical device includes a radiopaque marker located a) proximate to one of the first sensor or the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. The medical diagnostic system of claim 1 .

4. the medical device includes a radiopaque marker located a) proximate to one of the first sensor or the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. The medical diagnostic system of claim 2.

5. the electrical assembly includes a noise reduction sensor located at the distal portion of the medical device, the noise reduction sensor being spaced apart from the first sensor and the second sensor, the noise reduction sensor being located a) proximal to one of the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to one of the first sensor and the second sensor. The medical diagnostic system of claim 1 .

6. the electrical assembly includes a noise reduction sensor located at the distal portion of the medical device, the noise reduction sensor being spaced apart from the first sensor and the second sensor, the noise reduction sensor being located a) proximal to one of the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to one of the first sensor and the second sensor. A medical diagnostic system according to any one of claims 2 to 4.

7. further comprising an electronic circuit selected from the group consisting of a differential amplifier and an amplifier noise remover. The medical diagnostic system of claim 1 .

8. further comprising an electronic circuit selected from the group consisting of a differential amplifier and an amplifier noise remover. A medical diagnostic system according to one or more of claims 2-6.

9. the first sensor and / or the second sensor are exposed on an outer surface of the medical device such that at least a portion of the first sensor and / or the second sensor can contact an inner wall of the blood vessel or a substance disposed on the inner wall of the blood vessel when the distal portion of the medical device is located at the diagnostic site. The medical diagnostic system of claim 1 .

10. the first sensor and / or the second sensor are exposed on an outer surface of the medical device such that at least a portion of the first sensor and / or the second sensor can contact an inner wall of the blood vessel or a substance disposed on the inner wall of the blood vessel when the distal portion of the medical device is located at the diagnostic site. A medical diagnostic system according to any one of claims 2 to 8.

11. The medical device includes a tube, an outer surface of the tube including a first sensor recess and a second sensor recess, the first sensor recess configured to at least partially receive the first sensor, the second sensor recess configured to at least partially receive the second sensor, a top surface of the first sensor being flush or recessed with the outer surface of the tube when the first sensor is located in the first sensor recess, and a top surface of the second sensor being flush or recessed with the outer surface of the tube when the second sensor is located in the second sensor recess.

10. The medical diagnostic system of claim 9.

12. The medical device includes a tube, an outer surface of the tube including a first sensor recess and a second sensor recess, the first sensor recess configured to at least partially receive the first sensor, the second sensor recess configured to at least partially receive the second sensor, a top surface of the first sensor being flush or recessed with the outer surface of the tube when the first sensor is located in the first sensor recess, and a top surface of the second sensor being flush or recessed with the outer surface of the tube when the second sensor is located in the second sensor recess. The medical diagnostic system of claim 10.

13. the medical device includes a tube including an internal cavity, the internal cavity extending at least 3% of a longitudinal length of the tube, the electrical assembly including a first wire electrically connected to the first sensor and a second wire electrically connected to the second sensor, the first wire and the second wire being located within at least 10% of a longitudinal length of the cavity of the tube; The medical diagnostic system of claim 1 .

14. the medical device includes a tube including an internal cavity, the internal cavity extending at least 3% of a longitudinal length of the tube, the electrical assembly including a first wire electrically connected to the first sensor and a second wire electrically connected to the second sensor, the first wire and the second wire being located within at least 10% of a longitudinal length of the cavity of the tube; A medical diagnostic system according to any one of claims 2 to 12.

15. A majority of the longitudinal lengths of the first wire and the second wire disposed within the cavity are not connected to the cavity.

14. The medical diagnostic system of claim 13.

16. A majority of the longitudinal lengths of the first wire and the second wire disposed within the cavity are not connected to the cavity.

15. The medical diagnostic system of claim 14.

17. a distal portion of the medical device includes one or more recesses or cutouts configured to increase flexibility of the distal portion of the medical device, the one or more recesses or cutouts being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. The medical diagnostic system of claim 1 .

18. a distal portion of the medical device includes one or more recesses or cutouts configured to increase flexibility of the distal portion of the medical device, the one or more recesses or cutouts being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. A medical diagnostic system according to one or more of claims 2-16.

19. the medical device includes a rod located within the cavity of the tube and extending from a proximal end of the tube to a distal portion of the tube, the majority of the length of the rod being unconnected to the cavity; 14. The medical diagnostic system of claim 13.

20. the medical device includes a rod located within the cavity of the tube and extending from a proximal end of the tube to a distal portion of the tube, the majority of the length of the rod being unconnected to the cavity; A medical diagnostic system according to any one of claims 14 to 18.

21. the medical device includes a tube substrate, the first sensor and the second sensor being coupled to a top surface of the tube substrate; The medical diagnostic system of claim 1 .

22. the medical device includes a tube substrate, the first sensor and the second sensor being coupled to a top surface of the tube substrate; A medical diagnostic system according to any one of claims 2 to 20.

23. the tube substrate includes a skived region that reduces a cross-sectional area of ​​the skived region relative to regions of the tube substrate disposed proximal and / or distal to the skived region, and the first sensor and the second sensor are at least partially located on the skived region.

22. The medical diagnostic system of claim 21.

24. the tube substrate includes a skived region that reduces a cross-sectional area of ​​the skived region relative to regions of the tube substrate disposed proximal and / or distal to the skived region, and the first sensor and the second sensor are at least partially located on the skived region.

23. The medical diagnostic system of claim 22.

25. the tube substrate has a longitudinal length that is 1-25% of the longitudinal length of the body or tube of the medical device, and the tube substrate has a cross-sectional shape that is the same as or similar to a) the cross-sectional shape of the cavity of the tube, or b) a spatial region in the body; 22. The medical diagnostic system of claim 21.

26. the tube substrate has a longitudinal length that is 1-25% of the longitudinal length of the body or tube of the medical device, and the tube substrate has a cross-sectional shape that is the same as or similar to a) the cross-sectional shape of the cavity of the tube, or b) a spatial region in the body; A medical diagnostic system according to any one of claims 22 to 24.

27. the medical device includes a body or tube, the body or tube including a cutout region located at a distal portion of the body or tube, and the tube substrate is located within the cavity and oriented relative to the cutout region such that top surfaces of the first sensor and the second sensor connected to the top surface of the tube substrate are exposed to an exterior surface of the medical device.

22. The medical diagnostic system of claim 21.

28. the medical device includes a body or tube, the body or tube including a cutout region located at a distal portion of the body or tube, and the tube substrate is located within the cavity and oriented relative to the cutout region such that top surfaces of the first sensor and the second sensor connected to the top surface of the tube substrate are exposed to an exterior surface of the medical device. A medical diagnostic system according to any one of claims 22 to 26.

29. the medical device is a balloon guidewire, the balloon guidewire including a tube and an inflatable balloon, the outer surface of the balloon including the first sensor and the second sensor; The medical diagnostic system of claim 2.

30. the medical device is a balloon guidewire, the balloon guidewire including a tube and an inflatable balloon, the outer surface of the balloon including the first sensor and the second sensor; A medical diagnostic system according to any one of claims 3 to 28.

31. the medical device is a stent retriever, the stent retriever including a plurality of interconnected wires, the first sensor and the second sensor being connected to an outer surface of the interconnected wires. The medical diagnostic system of claim 2.

32. the medical device is a stent retriever, the stent retriever including a plurality of interconnected wires, the first sensor and the second sensor being connected to an outer surface of the interconnected wires. A medical diagnostic system according to any one of claims 3 to 10.

33. the distal portion of the medical device comprises a tapered region. The medical diagnostic system of claim 1 .

34. the distal portion of the medical device comprises a tapered region. A medical diagnostic system according to any one of claims 2 to 30.

35. the tapered region of the distal section being at least partially coated with a radiopaque material; 34. The medical diagnostic system of claim 33.

36. the tapered region of the distal section being at least partially coated with a radiopaque material; 35. The medical diagnostic system of claim 34.

37. 13. A method of using the medical diagnostic system of claim 1 to a) obtain one or more attributes of a thrombus in a blood vessel, and / or b) identify the presence or existence of cancer cells flowing in a blood vessel.

38. A method of using the medical diagnostic system of any one of claims 2 to 36 for a) obtaining one or more attributes of a thrombus in a blood vessel, and / or b) identifying the presence or existence of cancer cells flowing in a blood vessel.

39. 1. A medical device configured to be inserted into a blood vessel of an animal or human, the medical device comprising: a tube and an electrical assembly, the tube comprising an internal cavity extending at least 3% of a longitudinal length of the tube, the tube having a distal portion having a distal end, the tube having a proximal portion having a proximal end, the electrical assembly disposed at least partially in the distal portion of the tube, the electrical assembly comprising a first sensor and a second sensor, the electrical assembly comprising a first wire electrically connected to the first sensor and a second wire electrically connected to the second sensor, the first wire and the second wire being located within at least 10% of a longitudinal length of the cavity of the tube, the first sensor and the second sensor being disposed in the distal portion of the tube, and the electrical assembly configured to transmit and receive one or more electrical signals at a diagnostic site when the distal portion of the tube is disposed at the diagnostic site.

40. a) proximate one of the first sensor or the second sensor; b) between the first sensor and the second sensor; or c) distal to the first sensor and the second sensor.

40. The medical device of claim 39.

41. the electrical assembly includes a noise reduction sensor located in the distal portion of the tube, the noise reduction sensor being spaced apart from the first sensor and the second sensor, the noise reduction sensor being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor.

40. The medical device of claim 39.

42. the electrical assembly includes a noise reduction sensor located in the distal portion of the tube, the noise reduction sensor being spaced apart from the first sensor and the second sensor, the noise reduction sensor being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor.

41. The medical device of claim 40.

43. the first sensor or the second sensor is exposed on an outer surface of the tube such that at least a portion of the first sensor or the second sensor can contact an inner wall of a blood vessel or a substance disposed on the inner wall of the blood vessel when the distal portion of the tube is located at the diagnostic site.

40. The medical device of claim 39.

44. the first sensor or the second sensor is exposed on an outer surface of the tube such that at least a portion of the first sensor or the second sensor can contact an inner wall of a blood vessel or a substance disposed on the inner wall of the blood vessel when the distal portion of the tube is located at the diagnostic site. A medical device according to any one of claims 40-42.

45. an outer surface of the tube including a first sensor recess and a second sensor recess, the first sensor recess configured to at least partially receive the first sensor and the second sensor recess configured to at least partially receive the second sensor, a top surface of the first sensor being flush or recessed with the outer surface of the tube when the first sensor is located in the first sensor recess, and a top surface of the second sensor being flush or recessed with the outer surface of the tube when the second sensor is located in the second sensor recess; 40. The medical device of claim 39.

46. an outer surface of the tube including a first sensor recess and a second sensor recess, the first sensor recess configured to at least partially receive the first sensor and the second sensor recess configured to at least partially receive the second sensor, a top surface of the first sensor being flush or recessed with the outer surface of the tube when the first sensor is located in the first sensor recess, and a top surface of the second sensor being flush or recessed with the outer surface of the tube when the second sensor is located in the second sensor recess; A medical device according to any one of claims 40-44.

47. A majority of the longitudinal lengths of the first wire and the second wire disposed within the cavity are not connected to the cavity.

40. The medical device of claim 39.

48. A majority of the longitudinal lengths of the first wire and the second wire disposed within the cavity are not connected to the cavity. A medical device according to any one of claims 40-46.

49. a distal portion of the tube includes one or more depressions or cutouts configured to increase flexibility of the distal portion of the tube, the one or more depressions or cutouts being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor.

40. The medical device of claim 39.

50. a distal portion of the tube includes one or more depressions or cutouts configured to increase flexibility of the distal portion of the tube, the one or more depressions or cutouts being located a) proximal to the first sensor and the second sensor, b) between the first sensor and the second sensor, or c) distal to the first sensor and the second sensor. A medical device according to one or more of claims 40-48.

51. a rod located within the cavity of the tube and extending from a proximal end of the tube to a distal portion of the tube, the majority of the length of the rod being unconnected to the cavity; 40. The medical device of claim 39.

52. a rod located within the cavity of the tube and extending from a proximal end of the tube to a distal portion of the tube, the majority of the length of the rod being unconnected to the cavity; A medical device according to any one of claims 40-50.

53. a tube substrate at least partially positioned within the cavity of the tube, the first sensor and the second sensor being coupled to a top surface of the tube substrate, the tube substrate being formed of a different material than the tube.

40. The medical device of claim 39.

54. a tube substrate at least partially positioned within the cavity of the tube, the first sensor and the second sensor being coupled to a top surface of the tube substrate, the tube substrate being formed of a different material than the tube. A medical device according to any one of claims 40-52.

55. the tube substrate includes a skived region, the skived region reducing a cross-sectional area of ​​the skived region relative to a region of the tube substrate disposed proximal and / or distal to the skived region, and the first sensor and the second sensor being at least partially located on the skived region.

54. The medical device of claim 53.

56. the tube substrate includes a skived region, the skived region reducing a cross-sectional area of ​​the skived region relative to a region of the tube substrate disposed proximal and / or distal to the skived region, and the first sensor and the second sensor being at least partially located on the skived region.

55. The medical device of claim 54.

57. the tube substrate has a longitudinal length that is 1-25% of the longitudinal length of the tube, and the tube substrate has a cross-sectional shape that is the same as or similar to the cross-sectional shape of the cavity of the tube; 54. The medical device of claim 53.

58. the tube substrate has a longitudinal length that is 1-25% of the longitudinal length of the tube, and the tube substrate has a cross-sectional shape that is the same as or similar to the cross-sectional shape of the cavity of the tube; 57. A medical device according to any one of claims 54-56.

59. the tube includes a cut-out region located at the distal portion of the tube, and the tube substrate is located within the cavity and oriented relative to the cut-out region such that top surfaces of the first sensor and the second sensor coupled to the top surface of the tube substrate are exposed to an exterior surface of the medical device.

54. The medical device of claim 53.

60. the tube includes a cutout region located at the distal portion of the tube, and the tube substrate is located within the cavity and oriented relative to the cutout region such that top surfaces of the first sensor and the second sensor connected to the top surface of the tube substrate are exposed to an exterior surface of the medical device.

59. A medical device according to any one of claims 54-58.

61. the distal portion of the tube includes a tapered region; 40. The medical device of claim 39.

62. the distal portion of the tube includes a tapered region; A medical device according to any one of claims 40-60.

63. the tapered region being coated with a radiopaque material; 62. The medical device of claim 61.

64. the tapered region being coated with a radiopaque material; 63. The medical device of claim 62.

65. 40. A method of using the medical device of claim 39 to a) obtain one or more attributes of a thrombus in a blood vessel, and / or b) identify the presence or existence of cancer cells flowing in a blood vessel.

66. A method of using the medical device of any one of claims 40-46 for a) obtaining one or more attributes of a thrombus in a blood vessel, and / or b) identifying the presence or existence of cancer cells flowing in a blood vessel.

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