System for performing real-time aortic valve diameter measurement

Abstract

A method and apparatus for measuring the inflation diameter, cross-sectional area, and / or volume of an inflatable balloon on a balloon catheter, the method comprising: a) measuring at least a portion or all of the diameter of the medical device that is expanded within the body passageway; b) measuring at least a portion or all of the cross-sectional area of the medical device that is expanded within the body passageway; and / or c) measuring at least a portion or all of the volume of the medical device that is expanded within the body passageway, the diameter measurement device (DMD) being configured to perform the measurements, the DMD including a plurality of excitation electrodes and a plurality of sensor electrodes.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 359,401, filed Jul. 8, 2022, and U.S. Provisional Application No. 63 / 411,266, filed Sep. 29, 2022, both of which are hereby incorporated by reference in their entirety.

[0002] The present disclosure generally relates to medical devices and uses of medical devices, and more specifically, to the treatment of structural heart disease and medical devices used in cardiovascular implants, and even more specifically, to devices used to facilitate the implantation of artificial heart valves or transcatheter heart valves or balloon valvuloplasty.

Background Art

[0003] Many cardiovascular procedures, such as the implantation of stents and heart valves, and interventional cardiac procedures such as valvuloplasty, require the insertion of a balloon-expandable catheter and the expansion of the balloon at the treatment site. These consist of a collapsed balloon device that can be combined with crimped devices such as stents and expandable heart valves, inserted into the patient via the patient's vasculature, and then expanded at the treatment site. These devices are typically crimped onto a catheter prior to insertion into the patient.

[0004] Medical devices such as transcatheter aortic valves (TAV) represent an important advancement in artificial heart valve technology. TAV provides the benefits of heart valve replacement to patients who would otherwise not undergo surgery. Transcatheter aortic valve replacement (TAVR) can be used to treat aortic valve stenosis in patients classified as being at high risk for surgical aortic valve replacement (SAVR) by open heart surgery. Non-limiting TAVs are disclosed in U.S. Patent Nos. 5,411,522, 6,730,118, 10,729,543, 10,820,993, 10,856,970, 10,869,761, 10,952,852, 10,980,632, 10,980,633, and U.S. Publication No. 2020 / 0405482, all of which are hereby incorporated by reference in their entirety.

[0005] TAVs are designed to be compressed within a small-diameter catheter and deployed remotely within the diseased aortic valve of a patient to take over the function of the original valve. Some TAVs are balloon-expandable, while other TAVs are self-expandable. In either case, the TAV is deployed within the calcified original valve, which is forced to open permanently, providing a surface for the stent to be held in place by friction. TAVs can also be used to replace a failed bioprosthetic or transcatheter valve, which is generally known as a valve-in-valve procedure. The main advantage of TAVR over conventional surgical approaches is that it significantly reduces patient morbidity by avoiding the use of cardiopulmonary bypass, aortic cross-clamping, and sternotomy.

[0006] However, several complications are associated with current TAV devices, such as malposition, crimp-induced leaflet injury, paravalvular leakage, thrombosis, conduction abnormalities, and prosthesis-patient mismatch. These complications are potentially related to the distribution of calcification in the original valve, the geometric and mechanical properties of the aortic root, the blood biochemical properties and coagulability associated with the patient, and coexisting conditions such as hypertension, coronary artery disease, and heart failure.

[0007] During aortic valve replacement, sizing and dilation of the valve are key to providing a favorable clinical outcome for the patient. During the procedure, the clinician uses a catheter inserted into the femoral artery to implant a balloon-expandable stent frame. At the location of the aorta, the clinician dilates the stent to match the diameter of the vessel wall. Inadequate sizing can lead to serious adverse events in the clinical outcome, including perivalvular leakage (PVL). Overdilation of the valve can lead to damage to the myocardium around the heart valve and, in some cases, to the need for a cardiac pacemaker for cardiac pacing.

[0008] Valvuloplasty is a procedure for repairing a heart valve with a narrowed opening. In a narrowed heart valve (stenosis), the valve flap (cusp) may thicken or harden and fuse, reducing blood flow through the valve. Valvuloplasty can improve blood flow through the heart valve. During the procedure, a catheter with a balloon at its tip is inserted into a body passage and guided to the narrowed valve of the heart. When the balloon is in place, the balloon is inflated to widen the valve, thereby improving blood flow through the heart valve. The balloon is then deflated and the balloon catheter is removed from the heart valve. One problem associated with balloon valvuloplasty is that overdilation of the valve can lead to damage to the myocardium around the heart valve and, in some cases, to the need for a cardiac pacemaker for cardiac pacing.

[0009] Given the current state of the art of prosthetic heart valves or transcatheter heart valves, there is a need for a medical device that can provide real-time measurement of the diameter of a prosthetic heart valve or transcatheter heart valve when such a device is expanded within the heart valve to facilitate proper expansion of the medical device. Summary of the Invention Means for Solving the Problems

[0010] The present disclosure generally relates to medical devices and uses of medical devices, and more specifically to medical devices used for the treatment of structural heart disease and cardiovascular implants, and specifically to devices used to facilitate the implantation of expandable devices in the cardiovascular system, and more specifically to devices used to facilitate balloon valvuloplasty and to facilitate the implantation of an artificial heart valve or a transcatheter heart valve within the heart. In one non-limiting embodiment, a device is provided that can be used in a stent or artificial heart valve or transcatheter heart valve procedure to measure the diameter of an expandable stent, an expandable artificial heart valve, or a transcatheter heart valve when the stent or artificial heart valve or transcatheter heart valve is expanded in a blood vessel, heart valve, etc. Such a device, when used with an artificial heart valve or a transcatheter heart valve, can a) minimize paravalvular leakage (PVL) of the artificial heart valve or transcatheter heart valve, b) prevent overexpansion of the artificial heart valve or transcatheter heart valve within the heart, and / or c) minimize or prevent damage to the heart region where the artificial heart valve or transcatheter heart valve is expanded. Such a device, when used with a stent, can a) ensure proper expansion of the stent within the blood vessel, b) prevent overexpansion of the stent within the blood vessel, and / or c) minimize or prevent damage to the blood vessel from the expanded stent.

[0011] In one non-limiting aspect of the present disclosure, a diameter measurement device (DMD) is provided that can be used to measure in real time a) the diameter, b) the cross-sectional area, and / or c) the volume of a medical device expanded within the cardiovascular system.

[0012] In another and / or alternative non-limiting aspect of the present disclosure, a DMD is provided that can be used to measure in real time the diameter and / or cross-sectional area of a stent expanded within a blood vessel.

[0013] In another and / or alternative non-limiting aspect of the present disclosure, a DMD is provided that can be used to measure, in real time, the diameter and / or cross-sectional area of an artificial heart valve or a transcatheter heart valve when the artificial heart valve or transcatheter heart valve is expanded within the heart valve.

[0014] In another and / or alternative non-limiting aspect of the present disclosure, a DMD is provided that can be used to measure, in real time, the diameter and / or cross-sectional area of an expandable device (e.g., an expandable balloon, etc.) that expands and / or contracts within a blood vessel.

[0015] In another and / or alternative non-limiting aspect of the present disclosure, impedance planimetry is used to measure the diameter and / or cross-sectional area of a medical device (e.g., a stent, an artificial heart valve or a transcatheter heart valve, an expandable balloon, etc.) when the medical device is expanded within a blood vessel, within a heart valve, etc., by measuring the volume of an expandable balloon used to expand the medical device. Impedance planimetry can include one or more conductive electrodes located inside the expandable balloon. In one non-limiting configuration, impedance planimetry can be used in an array format to provide diameter measurements via an expandable balloon for measuring, in real time, the diameter and / or cross-sectional area of a medical device when the medical device is expanded.

[0016] In another and / or alternative non-limiting aspect of the present disclosure, a DMD that uses impedance planimetry to measure the diameter and / or cross-sectional area of a medical device is provided, and at least a portion of the DMD is located inside the inflatable balloon of a balloon catheter. In such a non-limiting configuration, a plurality of excitation electrodes are placed along the catheter shaft. The plurality of excitation electrodes are located inside the expandable balloon. One or more of the excitation electrodes can be positioned remotely from the inflatable balloon. One or more conductive wires are used to energize the excitation electrodes. One or more conductive wires extend from the inflatable balloon located at one end of the catheter to a location far from the inflatable balloon (e.g., the front portion of the catheter, etc.). The excitation electrodes can be fabricated by various means (e.g., cut hypo tubes, foil wrapping, or other means known in the art).

[0017] In another and / or alternative non-limiting aspect of the present disclosure, a DMD that uses impedance planimetry to measure the diameter and / or cross-sectional area of a medical device is provided, with at least two excitation electrodes located inside the inflatable balloon and at least two sensor electrodes also located inside the inflatable balloon. In one non-limiting configuration, a first and a second excitation electrode are placed inside the inflatable balloon, and a first and a second sensor electrode are positioned between the first and second excitation sensors. In another non-limiting configuration, the first and second sensor electrodes are spaced apart from each other at a distance closer than the separation distance between any sensor electrode and any excitation electrode. As can be understood, three or more excitation electrodes can be located inside the inflatable balloon and / or three or more sensor electrodes can be located inside the inflatable balloon. The size of the circuit including the excitation electrodes and sensor electrodes inside the inflatable balloon is non-limiting. Generally, the length of the circuit is from 0.05 to 6 inches (and all values and ranges therebetween). Generally, the length of the circuit located inside the inflatable balloon is less than or equal to the longitudinal length of the inflatable balloon, however, this is not essential.

[0018] In another and / or alternative non-limiting aspect of the present disclosure, a DMD is provided that uses impedance planimetry to measure the diameter and / or cross-sectional area of a medical device, and the excitation electrode and / or the sensor electrode can optionally be ring-shaped or semi-circular electrodes. As can be understood, electrodes of other shapes can be used.

[0019] In another and / or alternative non-limiting aspect of the present disclosure, a DMD is provided that uses impedance planimetry to measure the diameter and / or cross-sectional area of a medical device, and the plurality of excitation electrodes are configured to generate an AC signal that can be, but is not limited to, a sine wave, a rectangular wave, or a triangular wave. The spacing between the excitation electrodes from each other can be a function of the expanded diameter and / or cross-sectional area of the balloon to provide a uniform current density within the expandable balloon. The sensor electrodes can be differentially selected through multiplexed inputs to provide a differential electrode potential. This multiplexing mechanism can be used to increase the resolution of the system by measuring each segment individually and averaging adjacent segments to provide sub-segment measurements. The sensed differential electrode potential can be used to measure the expanded diameter and / or cross-sectional area of the expandable balloon, which is consequently used to measure the expanded diameter and / or cross-sectional area of the medical device. In one non-limiting configuration, the plurality of sensor electrodes and excitation sensors are separated by a fixed distance and connected to a voltage source via wires. A constant AC current source is supplied to the wires and an electric field is generated within the conductive medium contained within the expandable balloon. The diameter of the expandable balloon can be calculated by the following equation. V / I = R = L / Aσ = L / (π(D / 2) 2 ×σ) In the formula, R is resistance (impedance). R is equal to V / I. V is the AC voltage and I is the AC current. I is a known AC current, and V can be measured across the excitation electrode by using the sensor electrode. L is the fixed distance between the excitation electrodes. σ is a medium having conductivity at a certain temperature (for example, physiological saline solution, physiological saline, and dye mixture, etc.). D is the diameter of the expandable balloon. A is the cross-sectional area of the expandable balloon assuming that the cross-sectional area is uniform along the longitudinal length of the expandable balloon when the expandable balloon expands. This formula depends on the relationship between the conductor and the resistance of the fluid, and the resistance is inversely proportional to the conductivity affected by the cross-sectional area of the expandable balloon and the ion concentration (conductance) of the fluid medium.

[0020] In another and / or alternative non-limiting aspect of the present disclosure, a DMD using impedance planimetry is provided for measuring the diameter and / or cross-sectional area of a medical device, and the expandable balloon is optionally segmented and measured by a differential pair of excitation and sensor electrodes to enable measurement of the envelope of the diameter of the expandable balloon.

[0021] In another and / or alternative non-limiting aspect of the present disclosure, a DMD using impedance planimetry is provided for measuring the diameter and / or cross-sectional area of a medical device, and the circuit uses a constant voltage source across a known calibration resistor with high precision by injecting a voltage waveform. Then, the impedance measurement is performed sequentially (sequenced) across the electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment. The voltage waveform is not limited, but may be an AC signal such as a sine wave, a triangular waveform, or a rectangular wave. The voltage waveform may also be, or alternatively, a DC that is measured periodically.

[0022] In another and / or alternative non-limiting aspect of the present disclosure, a DMD is provided that uses impedance planimetry to measure the diameter and / or cross-sectional area of a medical device, and the circuitry used for impedance planimetry includes the use of an excitation source that generates an AC signal in the range of 50 hz to 50 khz (and all values and ranges therebetween). The AC signal of the sensor electrodes can be adjusted to extract peak values. Extraction of the peak values can be achieved by optionally using an RMS circuit detector or a peak detector for the AC waveform. The conditioning circuit can first buffer and then optionally multiplex to combine differential pairs, or can sample individually. The use of multiplexing can be used to reduce the size of the circuit. The sensed signal can be rectified using a diode, and the current peak can be held using a capacitor, thereby generating a DC signal. The DC signal can then optionally be fed to an analog-to-digital converter. The DC signal can optionally be further filtered to reduce or remove unwanted noise. These signal filtering techniques can use a DSP or an analog signal conditioner and can rely on techniques known in the art. The digitized signal can optionally be transmitted to a microcontroller to extract the average peak of the signal and calculate the resulting diameter and / or cross-sectional area of the inflatable balloon.

[0023] In another and / or alternative non-limiting aspect of the present disclosure, a DMD is provided that uses impedance planimetry to measure the diameter and / or cross-sectional area of a medical device and includes circuitry for transmitting data (such as inflatable balloon diameter information, etc.) to a remote location (such as a control unit, monitor, computer, network, etc.) either wired or wirelessly (such as Bluetooth®, RF, etc.). The calculated diameter and / or cross-sectional area values of the inflatable balloon can be displayed in real time on a monitor during inflation of the inflatable balloon and / or can be stored.

[0024] In another and / or alternative non-limiting aspect of the present disclosure, a DMD using impedance planimetry is provided for measuring the diameter and / or cross-sectional area of a medical device, and a temperature sensor is optionally positioned within or near the inflatable balloon. When the inflatable balloon is inserted into a patient's blood vessel, the temperature of the inflatable balloon changes. Also, when a medium such as a saline aqueous solution is inserted into the inflatable balloon to cause inflation of the inflatable balloon, the temperature of the saline changes between the time when the saline is first introduced into the catheter at one end and the time when the saline aqueous solution flows through the catheter and inflates the inflatable balloon. The optional temperature sensor is used to correct for changes in σ (medium conductivity) of a measured temperature of the medium within the inflatable balloon. The position of the temperature sensor on the catheter is non-limiting (e.g., within the inflatable balloon, at the end of the balloon catheter, at the proximal end of the balloon catheter, etc.).

[0025] In another and / or alternative non-limiting aspect of the present disclosure, a DMD using impedance planimetry is provided for measuring the diameter and / or cross-sectional area of a medical device, and a flow sensor is used to provide information regarding the total volume of fluid to the inflatable balloon. This sensor can be used to monitor the fluid flow rate and / or total fluid volume delivered to the inflatable balloon to provide additional information for measuring the diameter and / or cross-sectional area of the inflatable balloon based on the known relationship between the diameter and / or cross-sectional area of the inflatable balloon and the volume of the inflatable balloon.

[0026] In another and / or alternative non-limiting aspect of the present disclosure, a DMD using impedance planimetry is provided for measuring the diameter and / or cross-sectional area of a medical device, and a pressure sensor is positioned distal to the balloon or proximal to the inflation system and is used to assist in measuring the diameter of the balloon by known pressure-volume compliance calculations of the balloon.

[0027] In another and / or alternative non-limiting aspect of the present disclosure, a DMD that uses impedance planimetry to measure the diameter and / or cross-sectional area of a medical device is provided, and the reference container is used to provide reference information that can be used to further adjust the calculated diameter of the inflatable balloon. Since the fluid concentration of the medium may be unknown during the procedure, a reference measurement can be made at a known diameter to calculate the σ (medium conductivity) of a particular medium at a particular temperature. Before inflating the inflatable balloon within a body passage (e.g., a blood vessel, etc.) or within the heart, the fluid medium used in the medical procedure can be included in a reference tube (e.g., a cylindrical tube, etc.) having a fixed diameter (e.g., a constant diameter along the longitudinal length of the tube) and a known diameter. The fixed diameter of the reference tube can be a fixed diameter close to the expected diameter of the inflatable balloon when fully inflated within the body passage or within the heart, but this is not essential. The reference tube can optionally include a temperature monitor for measuring the temperature of the fluid medium within the reference tube. The electrode configuration on the reference tube is the same as, or substantially the same as, the electrode configuration within the inflatable balloon when the inflatable balloon is inflated. When the fluid medium fills the reference tube, the σ (medium conductivity) of the medium can be calculated based on a known AC current and the diameter and / or cross-sectional area of the reference tube. The measured temperature within the reference tube can optionally be used to determine the temperature adjustment of the σ (medium conductivity) based on the temperature of the medium. The reference tube can optionally be configured to be in fluid communication with the inflatable balloon during a medical procedure in which a medical device is inserted into a patient. In such a non-limiting configuration, since the composition of the medium within the inflatable balloon and the reference tube is the same or substantially the same, real-time correction of the σ (medium conductivity) can be obtained during the medical procedure, resulting in a more accurate diameter calculation of the inflatable balloon during inflation of the inflatable balloon. Also, if the balloon catheter includes a temperature sensor on or near the inflatable balloon, the measured temperature can be used to further provide real-time correction of the σ (medium conductivity) during the medical procedure.In one non-limiting embodiment, the temperature of the fluid medium within the reference tube can optionally be adjusted to be the same as or similar to the temperature provided by a temperature sensor on or near the inflatable balloon in order to provide a more accurate real-time correction of σ (medium conductivity) during a medical procedure, resulting in a more accurate calculation of the diameter and / or cross-sectional area of the inflatable balloon during inflation of the inflatable balloon. The calculation of σ (medium conductivity) can optionally be calculated for a plurality of concentrations of saline or for a contrast agent used to improve X-ray visibility prior to a medical procedure, can optionally be calculated once for each fluid load during a medical procedure, and / or can optionally be calculated in real time. The calculation of σ (medium conductivity) and / or the calculated diameter and / or cross-sectional area of the inflatable balloon can be achieved by use of a microcontroller, and such information can optionally be transmitted, either wired or wirelessly, in real time or near real time during a medical procedure to a monitor and / or storage device (e.g., smartphone, computer, network, tablet, etc.).

[0028] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided that is configured to measure a) at least a portion or all of the diameter, b) at least a portion or all of the cross-sectional area, and / or c) at least a portion or all of the volume of a medical device that is expanded within a body passageway.

[0029] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided for use with a medical device, the medical device optionally including a balloon catheter, the balloon catheter optionally including a catheter body having a distal portion, a central portion, and a proximal portion, the balloon catheter optionally including an inflatable balloon connected to the distal portion or near thereto.

[0030] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the DMDS including a plurality of excitation electrodes and a plurality of sensor electrodes, the plurality of excitation electrodes and the plurality of sensor electrodes being positioned inside an inflatable balloon and being spaced apart from each other.

[0031] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the DMDS including a plurality of wires that provide current to a plurality of excitation electrodes and a plurality of sensor electrodes, each of the plurality of excitation electrodes and the plurality of sensor electrodes partially or completely surrounding the plurality of wires.

[0032] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the DMDS configured to measure changes in cross-sectional area and pressure of impedance derivation of the inflatable balloon as the inflatable balloon expands to measure a) the diameter of at least a portion of a medical device expanded within a body passageway, b) the cross-sectional area of at least the portion of the medical device expanded within the body passageway, and / or c) the volume of at least the portion of the medical device expanded within the body passageway.

[0033] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the medical device including a stent or prosthetic heart valve positioned at least partially around the inflatable balloon.

[0034] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the distal portion of the catheter including a temperature sensor.

[0035] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the DMDS including a multiplexed input.

[0036] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the DMDS including a wireless transmitter that wirelessly transmits data to a remote location so that the data can be stored and / or displayed at the remote location.

[0037] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the DMD including a reference container, the reference container having: a) a fixed and constant cross-sectional area along the longitudinal length of the reference container; b) a fixed and constant volume; c) a fixed and constant cross-sectional area along the longitudinal length of the reference container; and / or d) a fixed and constant cross-sectional shape along the longitudinal length of the reference container, the reference container including a plurality of reference electrodes located within the reference container, the number, orientation, and / or spacing of the plurality of reference electrodes within the reference container being the same as or substantially the same as the number, orientation, and / or spacing of the excitation electrodes and the sensor electrodes within the inflatable balloon.

[0038] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the reference tube having a longitudinal length that is the same as or similar to that of the inflatable balloon.

[0039] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the reference tube being used to calculate the media conductivity of a media, the media optionally being used to inflate the inflatable balloon.

[0040] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, the media including physiological saline.

[0041] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, a constant voltage source having a high-precision waveform is used across a known calibration resistor, and impedance measurements are optionally sequentially performed across electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment.

[0042] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, further including a flow sensor that provides information regarding the total volume of fluid within an inflatable balloon, the flow sensor monitoring the fluid flow rate and / or total fluid volume delivered to the inflatable balloon and optionally used to provide additional information for measuring the diameter of at least a portion of a medical device, the cross-sectional area of at least a portion of the medical device, and / or the volume of at least a portion of the medical device based on a known relationship of the inflatable balloon.

[0043] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS) is provided, further including a pressure sensor located distal to the inflatable balloon and / or proximal to the inflation system, the pressure sensor optionally used to facilitate measuring the diameter, cross-sectional area, and / or volume of at least a portion of a medical device by known pressure-volume compliance calculations of the inflatable balloon and / or inflatable system.

[0044] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS), and a method for measuring a) the diameter of at least a portion of a medical device expanded within a body passageway, b) the cross-sectional area of at least a portion of a medical device expanded within a body passageway, and / or c) the volume of at least a portion of a medical device expanded within a body passageway are provided. The method includes: A) providing a medical device, the medical device including a balloon catheter, the balloon catheter including a catheter body having a distal portion, a central portion, and a proximal portion, the balloon catheter including an inflatable balloon connected to the distal portion or near thereto; B) providing a diameter measurement device (DMD), which is to provide a diameter measurement device (DMD) configured to measure i) the diameter of at least a portion of a medical device expanded within a body passageway, ii) the cross-sectional area of at least a portion of a medical device expanded within a body passageway, and / or iii) the volume of at least a portion of a medical device expanded within a body passageway. The DMD includes a plurality of excitation electrodes and a plurality of sensor electrodes, the plurality of excitation electrodes and the plurality of sensor electrodes being positioned inside the inflatable balloon and being spaced apart from each other; C) inserting a portion of the distal and central portions of the catheter into the body passageway; D) moving the distal portion of the catheter within the body passageway until the distal portion is positioned in the treatment area; E) expanding the inflatable balloon in the treatment area; F) measuring the cross-sectional area and pressure changes of the impedance of the inflatable balloon derived by the DMD to measure, in the treatment area, I) the diameter of at least a portion or all of the medical device expanded within the body passageway, II) the cross-sectional area of at least a portion or all of the medical device expanded within the body passageway, and / or III) the volume of at least a portion or all of the medical device expanded within the body passageway.

[0045] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS), and a method for measuring a) at least a portion or all of the diameter, b) at least a portion or all of the cross-sectional area, and / or c) at least a portion or all of the volume of a medical device deployed within a body passageway are provided, and measuring a) at least a portion or all of the diameter, b) at least a portion or all of the cross-sectional area, and / or c) at least a portion or all of the volume of a medical device deployed within a body passageway is in real-time or near real-time.

[0046] In another and / or alternative non-limiting aspect of the present disclosure, a diameter measurement device system (DMDS), and a method for measuring a) at least a portion or all of the diameter, b) at least a portion or all of the cross-sectional area, and / or c) at least a portion or all of the volume of a medical device deployed within a body passageway are provided, the step of measuring the change in impedance includes impedance planimetry, a constant voltage source having a high-precision waveform is used across a known calibration resistor, and the impedance measurement is optionally performed sequentially in order across the electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment.

[0047] These and other aspects and advantages will become apparent from a consideration of the differences between the present disclosure and the prior art, and when considering the non-limiting embodiments illustrated in the accompanying drawings.

[0048] The foregoing and other features and advantages of the present disclosure will become apparent from a consideration of the following detailed description presented in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0049]

Figure 1

[0050] The articles / devices, processes, and components disclosed herein can be more fully understood by reference to the accompanying drawings. These drawings are merely schematic diagrams based on convenience and ease of demonstration of the present disclosure, and thus are not intended to show the relative sizes and dimensions of the device or its components, and / or to define or limit the scope of the exemplary embodiments.

[0051] These and other advantages will be apparent to those skilled in the art upon reading and following this specification.

[0052] Certain terms are used in the following description for clarity, but these terms are intended to refer only to the particular structure of the embodiments selected for illustration in the drawings and are not intended to define or limit the scope of the present disclosure. It should be understood that like numeral designations in the drawings and the following description refer to components having like functions.

[0053] The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0054] As used in this specification and the claims, the term "comprising" may include embodiments of "consisting of" and "consisting essentially of". As used herein, the terms "comprise", "include", "having", "has", "can", "contain", and variations thereof are intended to be non-limiting transitional phrases, terms, or words that require the presence of the specified component / step and allow the presence of other components / steps. However, such description should also be construed as describing a composition or process "consisting of" the recited components / steps and "consisting essentially of" the recited components / steps, which allows only the presence of the specified components / steps, together with any unavoidable impurities that may result therefrom, and excludes other components / steps.

[0055] It should be understood that numerical values in the specification and claims of this application include numerical values that are the same as the recited value when reduced to a number of significant figures and a numerical value that differs from the recited value by less than the experimental error of the conventional measurement techniques of the type described in this application for determining the value.

[0056] All ranges disclosed herein include the recited endpoints and are combinable independently (e.g., the range of "2 grams to 10 grams" includes the endpoints, 2 grams and 10 grams, and all intermediate values).

[0057] The terms "about" and "approximately" can be used to include any numerical value that can vary without changing the basic function of that value. When used with a range, "about" and "approximately" also disclose the range defined by the absolute values of the two endpoints; for example, "about 2 to about 4" also discloses the range of "2 to 4". Generally, the terms "about" and "approximately" can refer to plus or minus 10% of the indicated number.

[0058] Percentages of elements should be considered to be weight percentages of the elements described, unless otherwise expressly stated.

[0059] Some portions of the embodiments for carrying out the invention herein are presented from the perspective of algorithms and symbolic representations of operations on data bits executed by conventional computer components including a central processing unit (CPU), a memory storage device for the CPU, and a connected display device. Descriptions and representations of these algorithms are means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is generally perceived as a self-consistent sequence of steps leading to a desired result. The steps are those requiring physical manipulation of physical quantities. Usually, though not necessarily, these quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. For primarily reasons of common usage, it is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, or numbers, etc.

[0060] However, it should be understood that all of these terms and similar terms are merely convenient labels associated with appropriate physical quantities and applied to these quantities. As is apparent from the discussion herein, unless otherwise specified, throughout this specification, discussions using terms such as "processing" or "operating" or "calculating" or "determining" or "displaying" refer to the operations and processes of a computer system or similar electronic computing device, and those operations and processes involve manipulating and transforming data represented as physical (electronic) quantities within the registers and memories of the computer system into other data similarly represented as physical (electronic) quantities within the memories or registers of the computer system or other such information storage, transmission, or display devices.

[0061] Exemplary embodiments are also related to apparatus for performing the operations discussed herein. This apparatus may be specially constructed for the required purposes or may include a general purpose computer selectively activated or reconfigured by a computer program stored in a computer. Such a computer program may be stored in any type of computer readable storage medium including, but not limited to, floppy disks, optical disks, CD-ROMs, and magnetic-optical disks, read only memory (ROM), random access memory (RAM), EPROM, EEPROM, magnetic or optical cards, or any type of disk suitable for storing electronic instructions, each coupled to a computer system bus.

[0062] The algorithms and displays presented in this specification are not inherently related to any particular computer or other device. It may prove convenient to use various general-purpose systems in conjunction with programs according to the teachings of this specification, or to construct more specialized devices for performing the methods described herein. The structures of these various systems will be apparent from the above description. Additionally, the exemplary embodiments are not described with reference to any particular programming language. As will be understood, various programming languages may be used to implement the teachings of the exemplary embodiments as described herein.

[0063] A machine-readable medium includes any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer). For example, a machine-readable medium includes read-only memory ("ROM"), random access memory ("RAM"), magnetic disk storage media, optical storage media, flash memory devices, and electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.).

[0064] The methods illustrated throughout this specification may be implemented in a computer program product executable on a computer. A computer program product may include a non-transitory computer-readable recording medium on which a control program is recorded, such as a disk or a hard drive. Common forms of non-transitory computer-readable media include, for example, floppy disks, flexible disks, hard disks, magnetic tapes, or any other magnetic storage media, CD-ROM, DVD, or any other optical media, RAM, PROM, EPROM, FLASH-EPROM, or other memory chips or cartridges, or any other tangible medium that can be read and used by a computer.

[0065] One non-limiting, exemplary embodiment is described herein. Of course, upon reading and understanding the foregoing detailed description, others may conceive of modifications and variations. The exemplary embodiments are intended to include all such modifications and variations as long as they are within the scope of the appended claims or the equivalents thereof.

[0066] Referring now to FIG. 1, a block diagram of a catheter 100 is illustrated that includes a diameter measurement device (DMD) 200 that can be used to measure in real time a) the diameter, b) the cross-sectional area, and / or c) the volume of a medical device expanded within the cardiovascular system. Positioned at the distal portion of the catheter 100 is an inflatable balloon 300.

[0067] The DMD 200 includes a plurality of wires 210 that conduct current from a power source (not shown). Positioned inside the inflatable balloon 300 are a plurality of excitation electrodes 220 and a plurality of sensor electrodes 230. Although two sensor electrodes 230 are illustrated as being disposed between the excitation electrodes 220, this is not essential.

[0068] A temperature sensor 400 is optionally positioned at or near the distal tip of the catheter 100.

[0069] Positioned at or near the rear end of the catheter 100 is an optional reference tube 500.

[0070] The reference tube 500 can optionally be fluidly connected to the body 110 of the catheter 100. The reference tube 500 is a tube with a fixed and constant diameter along the longitudinal length of the tube (e.g., a cylindrical tube, etc.) and / or has a fixed and constant cross-sectional shape and size, and the tube includes a circuit 510 that is the same as or similar to the DMD 200 within the inflatable balloon 300. Such a circuit 510 includes two excitation electrodes 520 and two sensor electrodes 530 positioned between the two excitation electrodes.

[0071] The body 110 can include one or more internal passages extending along the longitudinal length of the body 110. The one or more internal passages can include wires 210. The one or more internal passages include a fluid passage that allows fluid (e.g., saline, etc.) to flow from the proximal end of the catheter to the distal portion of the catheter, enabling the inflatable balloon to be inflated and deflated.

[0072] Accordingly, among the objects made apparent from the foregoing description, the objects described above are efficiently achieved, and certain changes can be made to the described structure without departing from the spirit and scope of the present invention. Thus, it is understood that all matters included in the above description and shown in the accompanying drawings are to be construed in an illustrative, and not a limiting, sense. The present invention has been described with reference to preferred embodiments and alternative embodiments. Modifications and variations will be apparent to those skilled in the art upon reading and understanding the detailed consideration of the present invention provided herein. The present invention is intended to embrace all such modifications and variations as fall within the scope of the present invention. Also, it is understood that the following claims are intended to cover all general and specific features of the present invention described herein, as well as all statements of the scope of the present invention that, as a matter of language, can fall therebetween. The present invention has been described with reference to preferred embodiments. These and other modifications of the preferred embodiments, as well as other embodiments of the present invention, will be apparent from the disclosure herein, whereby the foregoing description is to be construed merely as illustrative of the present invention and not as limiting. All such modifications and variations are intended to be included as long as they fall within the scope of the appended claims.

[0073] To assist the Patent Office and the readers of this application and any patents that may issue therefrom in construing the claims appended hereto, the applicant does not intend to invoke 35 U.S.C. § 112, paragraph 6, for any claim or element of a claim in the appended claims, unless the words "means for" or "step for" are expressly used in a particular claim.

[0074] (Appendix) (Appendix 1) A method for measuring at least a portion or all of the diameter, b) at least a portion or all of the cross-sectional area, and / or c) at least a portion or all of the volume of a medical device expanded within a body passageway, comprising: Providing the medical device, the medical device including a balloon catheter, the balloon catheter including a catheter body having a distal portion, a central portion, and a proximal portion, the balloon catheter including an inflatable balloon connected to the distal portion or near it; Providing a diameter measurement device (DMD) configured to measure a) at least a portion or all of the diameter, b) at least a portion or all of the cross-sectional area, and / or c) at least a portion or all of the volume of at least a portion or all of the medical device expanded within the body passageway, the DMD including a plurality of excitation electrodes and a plurality of sensor electrodes, the plurality of excitation electrodes and the plurality of sensor electrodes being positioned inside the inflatable balloon and being spaced apart from each other; Inserting a portion of the distal portion and the central portion of the catheter into the body passageway; Moving the distal portion of the catheter within the body passageway until the distal portion is positioned in a treatment area; Expanding the inflatable balloon in the treatment area; In the treatment area, measuring a change in impedance by the DMD to measure at least a part or all of a) the diameter of at least a part or all of the medical device expanded within the body passageway, b) the cross-sectional area of at least a part or all of the medical device expanded within the body passageway, and / or c) the volume of at least a part or all of the medical device expanded within the body passageway, wherein the change in impedance is at least partially related to the cross-sectional area and / or pressure of the inflatable balloon, and measuring; comprising a method.

[0075] (Appendix 2) The measuring of at least a part or all of a) the diameter of at least a part or all of the medical device expanded within the body passageway, b) the cross-sectional area of at least a part or all of the medical device expanded within the body passageway, and / or c) the volume of at least a part or all of the medical device expanded within the body passageway is in real time or substantially in real time, the method according to Appendix 1.

[0076] (Appendix 3) The medical device includes a stent or an artificial heart valve that is at least partially positioned around the inflatable balloon, the method according to Appendix 1.

[0077] (Appendix 4) The medical device includes a stent or an artificial heart valve that is at least partially positioned around the inflatable balloon, the method according to Appendix 2.

[0078] (Appendix 5) The distal portion of the catheter includes a temperature sensor, the method according to Appendix 1.

[0079] (Appendix 6) The distal portion of the catheter includes a temperature sensor, the method according to any one of Appendices 2 to 4.

[0080] (Appendix 7) The DMD is the method described in Appendix 1, including multiplexed inputs.

[0081] (Appendix 8) The DMD is the method described in any one of Appendices 2 - 6, including multiplexed inputs.

[0082] (Appendix 9) The DMD is the method described in Appendix 1, including a wireless transmitter for wirelessly transmitting the data to a remote location so that the data can be stored and / or displayed at the remote location.

[0083] (Appendix 10) The DMD is the method described in any one of Appendices 2 - 8, including a wireless transmitter for wirelessly transmitting the data to a remote location so that the data can be stored and / or displayed at the remote location.

[0084] (Appendix 11) The DMD includes a reference container, and the reference container has: a) a fixed and constant cross-sectional area along the longitudinal length of the reference container; b) a fixed and constant volume; c) a fixed and constant cross-sectional area along the longitudinal length of the reference container; and / or d) a fixed and constant cross-sectional shape along the longitudinal length of the reference container. The reference container includes a plurality of reference electrodes located within the reference container, and the number, orientation, and / or spacing of the plurality of reference electrodes within the reference container are the same as, or substantially the same as, the number, orientation, and / or spacing of the excitation electrodes and the sensor electrodes within the inflatable balloon. This is the method described in Appendix 1.

[0085] (Appendix 12) The DMD includes a reference container, and the reference container has: a) a fixed and constant cross-sectional area along the longitudinal length of the reference container; b) a fixed and constant volume; c) a fixed and constant cross-sectional area along the longitudinal length of the reference container; and / or d) a fixed and constant cross-sectional shape along the longitudinal length of the reference container. The reference container includes a plurality of reference electrodes located within the reference container, and the number, orientation, and / or spacing of the plurality of reference electrodes within the reference container are the same as, or substantially the same as, the number, orientation, and / or spacing of the excitation electrodes and the sensor electrodes within the inflatable balloon. The method according to any one of Supplementary Notes 2 to 10.

[0086] (Supplementary Note 13) The reference container has the same or similar a) longitudinal length, b) volume, c) cross-sectional area along the longitudinal length of the reference container, and / or d) cross-sectional shape along the longitudinal length of the reference container as the inflatable balloon when the inflatable balloon is partially or fully inflated. The method according to Supplementary Note 11.

[0087] (Supplementary Note 14) The reference container has the same or similar a) longitudinal length, b) volume, c) cross-sectional area along the longitudinal length of the reference container, and / or d) cross-sectional shape along the longitudinal length of the reference container as the inflatable balloon when the inflatable balloon is partially or fully inflated. The method according to Supplementary Note 12.

[0088] (Supplementary Note 15) The reference container is used to calculate the medium conductivity of a medium, and the medium is used to inflate the inflatable balloon. The method according to Supplementary Note 11.

[0089] (Supplementary Note 15) The reference container is used to calculate the medium conductivity of a medium, and the medium is used to inflate the inflatable balloon. The method according to any one of Supplementary Notes 12 to 14.

[0090] (Supplementary Note 16) The medium is the method described in Supplementary Note 15, which contains a physiological saline aqueous solution.

[0091] (Supplementary Note 16) The medium is the method described in Supplementary Note 16, which contains a physiological saline aqueous solution.

[0092] (Supplementary Note 17) The step of measuring the change in impedance includes impedance planimetry, a constant voltage source with a high-precision waveform is used across a known calibration resistor, and the impedance measurement is optionally sequentially sequenced across the electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment, according to the method described in Supplementary Note 1.

[0093] (Supplementary Note 18) The step of measuring the change in impedance includes impedance planimetry, a constant voltage source with a high-precision waveform is used across a known calibration resistor, and the impedance measurement is optionally sequentially sequenced across the electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment, according to the method described in any one of Supplementary Notes 2 to 16.

[0094] (Supplementary Note 19) The expandable balloon further includes a flow sensor that provides information regarding the total volume of fluid, and the flow sensor monitors the fluid flow rate and / or the total fluid volume delivered to the expandable balloon to optionally provide additional information for measuring at least a portion or all of the diameter, cross-sectional area, and / or volume of the medical device based on the known relationship of the expandable balloon, according to the method described in Supplementary Note 1.

[0095] (Supplementary Note 20) The method according to any one of Appendices 2 to 18, further comprising a flow sensor that provides information regarding the total volume of fluid to the inflatable balloon, the flow sensor monitoring the fluid flow rate and / or the total fluid volume delivered to the inflatable balloon to provide additional information for measuring at least a portion or all of the diameter, the cross-sectional area, and / or the volume of at least a portion or all of the medical device based on known relationships of the inflatable balloon, and being optionally used.

[0096] (Appendix 21) The method according to Appendix 1, further comprising a pressure sensor located distally of the inflatable balloon and / or proximally of the inflation system, the pressure sensor being optionally used to facilitate measuring at least a portion or all of the diameter, the cross-sectional area, and / or the volume of at least a portion or all of the medical device by known pressure-volume compliance calculations for the inflatable balloon and / or the inflation system.

[0097] (Appendix 22) The method according to any one of Appendices 2 to 20, further comprising a pressure sensor located distally of the inflatable balloon and / or proximally of the inflation system, the pressure sensor being optionally used to facilitate measuring at least a portion or all of the diameter, the cross-sectional area, and / or the volume of at least a portion or all of the medical device by known pressure-volume compliance calculations for the inflatable balloon and / or the inflation system.

[0098] (Appendix 23) A diameter measurement device system (DMDS) configured to measure a) at least a portion or all of the diameter of at least a portion or all of a medical device expanded within a body passageway, b) at least a portion or all of the cross-sectional area of at least a portion or all of the medical device expanded within the body passageway, and / or c) at least a portion or all of the volume of at least a portion or all of the medical device expanded within the body passageway, the DMDS comprising The medical device, wherein the medical device includes a balloon catheter, the balloon catheter includes a catheter body having a distal portion, a central portion, and a proximal portion, and the balloon catheter includes the inflatable balloon connected to or near the distal portion, the medical device and, A plurality of excitation electrodes and a plurality of sensor electrodes, wherein the plurality of excitation electrodes and the plurality of sensor electrodes are positioned inside the inflatable balloon, and the plurality of excitation electrodes and the plurality of sensor electrodes are spaced apart from each other, the plurality of excitation electrodes and the plurality of sensor electrodes and, A plurality of wires for providing current to the plurality of excitation electrodes and the plurality of sensor electrodes, wherein each of the plurality of excitation electrodes and the plurality of sensor electrodes partially or completely surrounds the plurality of wires, the plurality of wires and, Comprising, When the inflatable balloon expands, the DMDS measures changes in the cross-sectional area and pressure of impedance derivation of the inflatable balloon to measure a) at least a part or all of the diameter of the medical device expanded in the body passage, b) at least a part or all of the cross-sectional area of the medical device expanded in the body passage, and / or c) at least a part or all of the volume of the medical device expanded in the body passage. Diameter measurement device system (DMDS).

[0099] (Appendix 24) The medical device according to Appendix 23, including a stent or an artificial heart valve at least partially positioned around the inflatable balloon.

[0100] (Appendix 25) The diameter measurement device system according to Appendix 23, wherein the distal portion of the catheter includes a temperature sensor.

[0101] (Appendix 26) The distal portion of the catheter is the diameter measurement device system according to appended claim 24, including a temperature sensor.

[0102] (Appended claim 27) The DMDS is the diameter measurement device system according to appended claim 23, including multiplexed inputs.

[0103] (Appended claim 28) The DMDS is the diameter measurement device system according to any one of appended claims 24 to 26, including multiplexed inputs.

[0104] (Appended claim 29) The DMDS is the diameter measurement device system according to appended claim 23, including a wireless transmitter for wirelessly transmitting the data to a remote location so that the data can be stored and / or displayed at the remote location.

[0105] (Appended claim 30) The DMDS is the diameter measurement device system according to any one of appended claims 24 to 28, including a wireless transmitter for wirelessly transmitting the data to a remote location so that the data can be stored and / or displayed at the remote location.

[0106] (Appended claim 31) The DMD includes a reference container, and the reference container has: a) a fixed and constant cross-sectional area along the longitudinal length of the reference container; b) a fixed and constant volume; c) a fixed and constant cross-sectional area along the longitudinal length of the reference container; and / or d) a fixed and constant cross-sectional shape along the longitudinal length of the reference container. The reference container includes a plurality of reference electrodes located within the reference container, and the number, orientation, and / or spacing of the plurality of reference electrodes within the reference container are the same as, or substantially the same as, the number, orientation, and / or spacing of the excitation electrodes and the sensor electrodes within the inflatable balloon. The diameter measurement device system according to appended claim 23.

[0107] (Appended claim 32) The DMD includes a reference container, and the reference container has: a) a fixed and constant cross-sectional area along the longitudinal length of the reference container; b) a fixed and constant volume; c) a fixed and constant cross-sectional area along the longitudinal length of the reference container; and / or d) a fixed and constant cross-sectional shape along the longitudinal length of the reference container. The reference container includes a plurality of reference electrodes located within the reference container, and the number, orientation, and / or spacing of the plurality of reference electrodes within the reference container are the same as or substantially the same as the number, orientation, and / or spacing of the excitation electrodes and the sensor electrodes within the inflatable balloon. A diameter measurement device system according to any one of Supplementary Notes 24 to 30.

[0108] (Supplementary Note 33) The reference container has, when the inflatable balloon is partially or fully inflated, the same or similar a) longitudinal length, b) volume, c) cross-sectional area along the longitudinal length of the reference container, and / or d) cross-sectional shape along the longitudinal length of the reference container as the inflatable balloon. A diameter measurement device system according to Supplementary Note 31.

[0109] (Supplementary Note 34) The reference container has, when the inflatable balloon is partially or fully inflated, the same or similar a) longitudinal length, b) volume, c) cross-sectional area along the longitudinal length of the reference container, and / or d) cross-sectional shape along the longitudinal length of the reference container as the inflatable balloon. A diameter measurement device system according to Supplementary Note 32.

[0110] (Supplementary Note 35) The reference container is used to calculate the medium conductivity of a medium, and the medium is used to inflate the inflatable balloon. A diameter measurement device system according to Supplementary Note 31.

[0111] (Supplementary Note 36) The reference container is used to calculate the conductivity of the medium, and the medium is the diameter measurement device system according to any one of Appendices 32 to 34, which is used to inflate the inflatable balloon.

[0112] (Appendix 37) The medium is the diameter measurement device system according to Appendix 35, which contains a physiological saline aqueous solution.

[0113] (Appendix 38) The medium is the diameter measurement device system according to Appendix 36, which contains a physiological saline aqueous solution.

[0114] (Appendix 39) A constant voltage source having a high-precision waveform is used across a known calibration resistor, and impedance measurement is optionally sequentially (sequenced) across the electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment. The diameter measurement device system according to Appendix 23.

[0115] (Appendix 40) A constant voltage source having a high-precision waveform is used across a known calibration resistor, and impedance measurement is optionally sequentially (sequenced) across the electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment. The diameter measurement device system according to any one of Appendices 24 to 38.

[0116] (Appendix 41) Further includes a flow sensor for providing information regarding the total volume of fluid within the inflatable balloon, the flow sensor monitoring the fluid flow rate and / or total fluid volume delivered to the inflatable balloon, and for providing additional information for measuring at least a portion or all of the diameter, at least a portion or all of the cross-sectional area, and / or at least a portion or all of the volume of the medical device based on known relationships of the inflatable balloon, a diameter measurement device system according to Supplementary Note 23, optionally used.

[0117] (Supplementary Note 42) Further includes a flow sensor for providing information regarding the total volume of fluid within the inflatable balloon, the flow sensor monitoring the fluid flow rate and / or total fluid volume delivered to the inflatable balloon, and for providing additional information for measuring at least a portion or all of the diameter, at least a portion or all of the cross-sectional area, and / or at least a portion or all of the volume of the medical device based on known relationships of the inflatable balloon, a diameter measurement device system according to any one of Supplementary Notes 24 to 40, optionally used.

[0118] (Supplementary Note 43) Further includes a pressure sensor located distally of the inflatable balloon and / or proximally of the inflation system, the pressure sensor optionally used to facilitate measuring at least a portion or all of the diameter, the cross-sectional area, and / or the volume of the medical device by known pressure-volume compliance calculations for the inflatable balloon and / or the inflation system, a diameter measurement device system according to Supplementary Note 23.

[0119] (Supplementary Note 44) Further comprising a pressure sensor located distally of the inflation balloon and / or proximally of the inflation system, the pressure sensor being optionally used to facilitate measurement of at least a portion or all of the diameter, cross-sectional area, and / or volume of the medical device by known pressure-volume compliance calculations for the inflatable balloon and / or the inflation system, a diameter measurement device system according to any one of Appendices 24 to 42.

Claims

Claim 1 A method for measuring at least a portion or all of the diameter, b) at least a portion or all of the cross-sectional area, and / or c) at least a portion or all of the volume of a medical device expanded within a body passageway, comprising: Providing the medical device, the medical device including a balloon catheter, the balloon catheter including a catheter body having a distal portion, a central portion, and a proximal portion, the balloon catheter including an inflatable balloon connected to the distal portion or near it; Providing a diameter measurement device (DMD) configured to measure a) at least a portion or all of the diameter, b) at least a portion or all of the cross-sectional area, and / or c) at least a portion or all of the volume of at least a portion or all of the medical device expanded within the body passageway, the DMD including a plurality of excitation electrodes and a plurality of sensor electrodes, the plurality of excitation electrodes and the plurality of sensor electrodes being positioned inside the inflatable balloon and being spaced apart from each other; Inserting a portion of the distal portion and the central portion of the catheter into the body passageway; Moving the distal portion of the catheter within the body passageway until the distal portion is positioned in a treatment area; Expanding the inflatable balloon in the treatment area; Measuring, in the treatment area, a change in impedance by the DMD to measure a) at least a portion or all of the diameter, b) at least a portion or all of the cross-sectional area, and / or c) at least a portion or all of the volume of at least a portion or all of the medical device expanded within the body passageway, the change in impedance being at least partially related to the cross-sectional area and / or pressure of the inflatable balloon; comprising: Method. Claim 2 Measuring at least a portion or all of a) the diameter, b) the cross-sectional area, and / or c) the volume of the medical device expanded within the body passageway is in real-time or near real-time, the method according to claim 1.

3. The medical device includes a stent or an artificial heart valve positioned at least partially around the inflatable balloon, the method according to claim 1.

4. The medical device includes a stent or an artificial heart valve positioned at least partially around the inflatable balloon, the method according to claim 2.

5. The distal portion of the catheter includes a temperature sensor, the method according to claim 1.

6. The distal portion of the catheter includes a temperature sensor, the method according to any one of claims 2 to 4.

7. The DMD includes a multiplexed input, the method according to claim 1.

8. The DMD includes a multiplexed input, the method according to any one of claims 2 to 6.

9. The DMD includes a wireless transmitter that wirelessly transmits the data to a remote location so that the data can be stored and / or displayed at the remote location, the method according to claim 1.

10. The DMD includes a wireless transmitter that wirelessly transmits the data to a remote location so that the data can be stored and / or displayed at the remote location, the method according to any one of claims 2 to 8.

11. The DMD includes a reference container, the reference container having a) a fixed and constant cross-sectional area along the longitudinal length of the reference container, b) a fixed and constant volume, c) a fixed and constant cross-sectional area along the longitudinal length of the reference container, and / or d) a fixed and constant cross-sectional shape along the longitudinal length of the reference container, the reference container including a plurality of reference electrodes positioned within the reference container, the number, orientation, and / or spacing of the plurality of reference electrodes within the reference container being the same as or substantially the same as the number, orientation, and / or spacing of the excitation electrodes and the sensor electrodes within the inflatable balloon, the method according to claim 1.

12. The DMD includes a reference container, and the reference container has: a) a fixed and constant cross-sectional area along the longitudinal length of the reference container; b) a fixed and constant volume; c) a fixed and constant cross-sectional area along the longitudinal length of the reference container; and / or d) a fixed and constant cross-sectional shape along the longitudinal length of the reference container. The reference container includes a plurality of reference electrodes located within the reference container, and the number, orientation, and / or spacing of the plurality of reference electrodes within the reference container is the same as or substantially the same as the number, orientation, and / or spacing of the excitation electrodes and the sensor electrodes within the inflatable balloon. The method according to any one of claims 2 to 10.

13. The reference container has the same or a similar a) longitudinal length, b) volume, c) cross-sectional area along the longitudinal length of the reference container, and / or d) cross-sectional shape along the longitudinal length of the reference container as the inflatable balloon when the inflatable balloon is partially or fully inflated. The method according to claim 11.

14. The reference container has the same or a similar a) longitudinal length, b) volume, c) cross-sectional area along the longitudinal length of the reference container, and / or d) cross-sectional shape along the longitudinal length of the reference container as the inflatable balloon when the inflatable balloon is partially or fully inflated. The method according to claim 12.

15. The reference container is used to calculate the medium conductivity of a medium, and the medium is used to inflate the inflatable balloon. The method according to claim 11.

15. The reference container is used to calculate the medium conductivity of a medium, and the medium is used to inflate the inflatable balloon. The method according to any one of claims 12 to 14.

16. The medium includes a physiological saline aqueous solution. The method according to claim 15.

16. The medium includes a physiological saline aqueous solution. The method according to claim 16.

17. The step of measuring the change in impedance includes impedance planimetry, a constant voltage source having a high-precision waveform is used across a known calibration resistor, and the impedance measurement is optionally sequenced across the electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment. The method according to claim 1.

18. The step of measuring the change in impedance includes impedance planimetry, a constant voltage source having a high-precision waveform is used across a known calibration resistor, and the impedance measurement is optionally sequenced across the electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment. The method according to any one of claims 2 to 16.

19. The method according to claim 1, further comprising a flow sensor that provides information regarding the total volume of fluid to the inflatable balloon, the flow sensor optionally being used to monitor the fluid flow rate and / or total fluid volume delivered to the inflatable balloon to provide additional information for measuring at least a portion or all of the diameter, cross-sectional area, and / or volume of the medical device based on known relationships of the inflatable balloon.

20. The method according to any one of claims 2 to 18, further comprising a flow sensor that provides information regarding the total volume of fluid to the inflatable balloon, the flow sensor optionally being used to monitor the fluid flow rate and / or total fluid volume delivered to the inflatable balloon to provide additional information for measuring at least a portion or all of the diameter, cross-sectional area, and / or volume of the medical device based on known relationships of the inflatable balloon.

21. The method according to claim 1, further comprising a pressure sensor located distally of the inflation balloon and / or proximally of the inflation system, the pressure sensor optionally being used to facilitate measuring at least a portion or all of the diameter, the cross-sectional area, and / or the volume of at least a portion or all of the medical device by known pressure-volume compliance calculations for the inflatable balloon and / or the inflation system.

22. The method according to any one of claims 2 to 20, further comprising a pressure sensor located distally of the inflation balloon and / or proximally of the inflation system, the pressure sensor optionally being used to facilitate measuring at least a portion or all of the diameter, the cross-sectional area, and / or the volume of at least a portion or all of the medical device by known pressure-volume compliance calculations for the inflatable balloon and / or the inflation system.

23. A diameter measurement device system (DMDS) configured to measure a) at least a portion or all of the diameter of a medical device expanded within a body passageway, b) at least a portion or all of the cross-sectional area of the medical device expanded within the body passageway, and / or c) at least a portion or all of the volume of the medical device expanded within the body passageway, the DMDS comprising: The medical device, the medical device including a balloon catheter, the balloon catheter including a catheter body having a distal portion, a central portion, and a proximal portion, the balloon catheter including the inflatable balloon connected to or near the distal portion, the medical device; A plurality of excitation electrodes and a plurality of sensor electrodes, the plurality of excitation electrodes and the plurality of sensor electrodes being positioned inside the inflatable balloon, the plurality of excitation electrodes and the plurality of sensor electrodes being spaced apart from each other, the plurality of excitation electrodes and the plurality of sensor electrodes; A plurality of wires for providing current to the plurality of excitation electrodes and the plurality of sensor electrodes, each of the plurality of excitation electrodes and the plurality of sensor electrodes partially or completely surrounding the plurality of wires, the plurality of wires; Comprising. When the expandable balloon expands, the DMDS measures changes in the cross-sectional area and pressure of impedance derivation of the expandable balloon to measure a) at least a part or all of the diameters of the medical device expanded within the body passage, b) at least a part or all of the cross-sectional areas of the medical device expanded within the body passage, and / or c) at least a part or all of the volumes of the medical device expanded within the body passage. Diameter measurement device system (DMDS).

24. The diameter measurement device system according to claim 23, wherein the medical device includes a stent or an artificial heart valve that is at least partially positioned around the expandable balloon.

25. The diameter measurement device system according to claim 23, wherein the distal portion of the catheter includes a temperature sensor.

26. The diameter measurement device system according to claim 24, wherein the distal portion of the catheter includes a temperature sensor.

27. The diameter measurement device system according to claim 23, wherein the DMDS includes a multiplexed input.

28. The diameter measurement device system according to any one of claims 24 to 26, wherein the DMDS includes a multiplexed input.

29. The diameter measurement device system according to claim 23, wherein the DMDS includes a wireless transmitter that wirelessly transmits the data to a remote location so that the data can be stored and / or displayed at the remote location.

30. The diameter measurement device system according to any one of claims 24 to 28, wherein the DMDS includes a wireless transmitter that wirelessly transmits the data to a remote location so that the data can be stored and / or displayed at the remote location.

31. The DMD includes a reference container, and the reference container has: a) a fixed and constant cross-sectional area along the longitudinal length of the reference container; b) a fixed and constant volume; c) a fixed and constant cross-sectional area along the longitudinal length of the reference container; and / or d) a fixed and constant cross-sectional shape along the longitudinal length of the reference container. The reference container includes a plurality of reference electrodes located within the reference container, and the number, orientation, and / or spacing of the plurality of reference electrodes within the reference container is the same as or substantially the same as the number, orientation, and / or spacing of the excitation electrodes and the sensor electrodes within the inflatable balloon. The diameter measurement device system according to claim 23.

32. The DMD includes a reference container, and the reference container has: a) a fixed and constant cross-sectional area along the longitudinal length of the reference container; b) a fixed and constant volume; c) a fixed and constant cross-sectional area along the longitudinal length of the reference container; and / or d) a fixed and constant cross-sectional shape along the longitudinal length of the reference container. The reference container includes a plurality of reference electrodes located within the reference container, and the number, orientation, and / or spacing of the plurality of reference electrodes within the reference container is the same as or substantially the same as the number, orientation, and / or spacing of the excitation electrodes and the sensor electrodes within the inflatable balloon. The diameter measurement device system according to any one of claims 24 to 30.

33. The reference container has the same or a similar a) longitudinal length, b) volume, c) cross-sectional area along the longitudinal length of the reference container, and / or d) cross-sectional shape along the longitudinal length of the reference container as the inflatable balloon when the inflatable balloon is partially or fully inflated. The diameter measurement device system according to claim 31.

34. The reference container has the same or a similar a) longitudinal length, b) volume, c) cross-sectional area along the longitudinal length of the reference container, and / or d) cross-sectional shape along the longitudinal length of the reference container as the inflatable balloon when the inflatable balloon is partially or fully inflated. The diameter measurement device system according to claim 32.

35. The reference container is used to calculate the conductivity of a medium, and the medium is used to inflate the inflatable balloon, the diameter measurement device system according to claim 31.

36. The reference container is used to calculate the conductivity of a medium, and the medium is used to inflate the inflatable balloon, the diameter measurement device system according to any one of claims 32 to 34.

37. The medium includes a physiological saline aqueous solution, the diameter measurement device system according to claim 35.

38. The medium includes a physiological saline aqueous solution, the diameter measurement device system according to claim 36.

39. A constant voltage source having a high-precision waveform is used across a known calibration resistor, and impedance measurements are optionally sequentially (sequenced) across the electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment, the diameter measurement device system according to claim 23.

40. A constant voltage source having a high-precision waveform is used across a known calibration resistor, and impedance measurements are optionally sequentially (sequenced) across the electrodes for segmental impedance measurement using the calibrated current value and the voltage measured from each segment, the diameter measurement device system according to any one of claims 24 to 38.

41. The diameter measurement device system according to claim 23 further includes a flow sensor that provides information regarding the total volume of fluid within the inflatable balloon, the flow sensor monitoring the fluid flow rate and / or total fluid volume delivered to the inflatable balloon and optionally used to provide additional information for measuring at least a portion or all of the diameter, at least a portion or all of the cross-sectional area, and / or at least a portion or all of the volume of the medical device based on known relationships of the inflatable balloon.

42. The diameter measurement device system according to any one of claims 24 to 40, further comprising a flow sensor that provides information regarding the total volume of fluid within the inflatable balloon, the flow sensor monitoring the fluid flow rate and / or total fluid volume delivered to the inflatable balloon, and optionally used to provide additional information for measuring at least a portion or all of the diameter, at least a portion or all of the cross-sectional area, and / or at least a portion or all of the volume of the medical device based on known relationships of the inflatable balloon.

43. The diameter measurement device system according to claim 23, further comprising a pressure sensor located distally of the inflatable balloon and / or proximally of the inflation system, the pressure sensor optionally used to facilitate measuring at least a portion or all of the diameter, the cross-sectional area, and / or the volume of the medical device by known pressure-volume compliance calculations for the inflatable balloon and / or the inflation system.

44. The diameter measurement device system according to any one of claims 24 to 42, further comprising a pressure sensor located distally of the inflatable balloon and / or proximally of the inflation system, the pressure sensor optionally used to facilitate measuring at least a portion or all of the diameter, the cross-sectional area, and / or the volume of the medical device by known pressure-volume compliance calculations for the inflatable balloon and / or the inflation system.

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