CATHETER FOR IMAGING AND MEASURING PRESSURE AND OTHER PHYSIOLOGICAL PARAMETERS - Patent application

Abstract

The catheter system includes an elongated tubular structure configured to be inserted into a body lumen space, such as a vascular structure. The catheter is electrically conductive and configured to conduct electrical signals. The catheter includes one or more power and data coupling devices configured to transmit and receive power and / or data signals, such as from an underlying guidewire disposed within the lumen of the catheter. One or more sensors are coupled to a distal section of the catheter and electrically connected to the one or more power and data coupling devices.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 992,695, entitled "CATHETER SYSTEM, DEVICE, AND METHOD THEREOF," filed March 20, 2020, U.S. Provisional Patent Application No. 63 / 044,960, entitled "CATHETER AND GUIDEWIRE SYSTEMS WITH ENHANCED LOCATION AND CHARACTERIZATION FEATURES," filed June 26, 2020, and U.S. Patent Application No. 17 / 205,854, entitled "CATHETER FOR IMAGING AND MEASUREMENT OF PRESSURE AND OTHER PHYSIOLOGICAL PARAMETERS," filed March 18, 2021. The entire contents of each of the above applications are incorporated herein by reference in their entirety.

[0002] Additionally, this application is related to U.S. Patent Application No. 17 / 205,614, entitled "SIGNAL CONDUCTING DEVICE FOR CONCURRENT POWER AND DATA TRANSFER TO AND FROM UN-WIRED SENSORS ATTACHED TO A MEDICAL DEVICE," filed March 18, 2021, U.S. Patent Application No. 17 / 205,754, entitled "OPERATIVELY COUPLED DATA AND POWER TRANSFER DEVICE FOR MEDICAL GUIDEWIRES AND CATHETERS WITH SENSORS," filed March 18, 2021, and U.S. Patent Application No. 17 / 205,964, entitled "GUIDEWIRE FOR IMAGING AND MEASUREMENT OF PHYSIOLOGICAL PARAMETERS," filed March 18, 2021. The entire contents of each of the above applications are incorporated herein by reference in their entirety.

[0003] The present invention relates generally to medical devices, including intraluminal devices such as guidewires and catheters that contain a variety of sensors for simultaneous and / or continuous measurement of one or more physiological parameters. [Background technology]

[0004]

[0004] Guidewire devices are often used to guide or guide catheters or other interventional devices to targeted anatomical locations within a patient. Typically, the guidewire is threaded through the patient's vasculature to reach the target location, which may be located, for example, at or near the patient's heart or brain. Typically, radiological imaging is used to assist in guiding the guidewire to the targeted location. Guidewires are available having a variety of outer diameter sizes. Commonly used sizes include, for example, diameters of 0.010 inches, 0.014 inches, 0.016 inches, 0.018 inches, 0.024 inches, and 0.035 inches, although smaller or larger diameters may also be used. Catheters are also provided in a variety of sizes and are typically configured for use with standard guidewire sizes.

[0005]

[0005] In many instances, a guidewire is placed within the body during an interventional procedure and can be used to guide multiple catheters or other interventional devices to targeted anatomical locations. Once in position, the catheters can be used to aspirate blood clots or other obstructions, or to deliver drugs, stents, embolic devices, radiopaque dyes, or other devices or substances to treat the patient.

[0006]

[0006] These types of interventional devices can include sensors located at their distal ends to provide additional functionality to the devices. For example, intravascular ultrasound (IVUS) is an imaging technique that utilizes a catheter with an ultrasound imaging sensor attached to its distal end. Ultrasound is used to image within targeted vascular structures, typically the coronary arteries.

[0007]

[0007] The use of such sensors presents several challenges. In particular, the associated interventional devices have very limited space to work in, given the stringent dimensional constraints involved. Furthermore, it can be difficult to integrate the sensors into the interventional device in a way that maintains effective functionality.

[0008] Another problem common to this field is proper localization and positioning of the distal end of the device at the target site. If the device tip is improperly positioned during insertion or if the tip moves from the desired location after insertion, various risks can occur. For example, in a catheter implementation, improper positioning can lead to fluid seepage, which can cause pain or injury to the patient, increased thrombosis rates, delayed treatment, device damage or malfunction, delays and additional costs associated with device replacement, and additional time required by the attending physician and medical center.

[0009]

[0009] Furthermore, conventional techniques for internal imaging and localization of catheters require the injection of dyes and / or the use of x-rays, each of which can be harmful to the patient. Moreover, such imaging radiation can also be harmful to physicians and personnel who are exposed to the radiation.

[0010]

[0010] The use of such interventional devices is also challenging due to the need to manage several long lengths of wires and other components, including guidewires and catheters, power cables, data wires, etc. Care must be taken as to what is permitted in the sterile field and when it can be removed. Often additional personnel are required simply to manage such wires and cables. Summary of the Invention [Problem to be solved by the invention]

[0011]

[0011] Thus, there is currently a need for improved interventional devices that effectively integrate sensors, effectively manage power and data communication with the sensors, effectively communicate data from the device for further processing, and enable more effective positioning of medical devices at desired target locations within vascular structures or other targeted anatomical structures. [Means for solving the problem]

[0012] In one embodiment, a catheter system includes a catheter configured to be inserted into a body, the tube structure having a proximal end, a distal end, and a lumen extending through the proximal and distal ends, one or more sensors of one or more sensor types coupled to a distal section of the tube structure, and one or more wires associated with the tube structure and electrically connectable to the one or more sensors, and a first power and data coupling device operatively associated with the tube structure and configured to conductively couple to the one or more wires, thereby transmitting and receiving electrical signals through the one or more wires.

[0013] In some embodiments, the one or more wires include one or more power and / or data lines that extend across or through a wall of the tube structure between the first power and data coupling device and the one or more sensors, such that the first power and data coupling device can communicate with one or more sensors in the distal section of the catheter via the one or more power and / or data lines.

[0014] In some embodiments, a catheter system includes a first proximal power and data coupling device disposed at a proximal section of the catheter and a second distal power and data coupling device disposed at a distal section of the catheter. The catheter is configured to receive a guidewire. The proximal power and data coupling device and the distal power and data coupling device are configured to conductively contact the guidewire when the guidewire is inserted through the lumen of the tubular structure, thereby enabling passage of electrical signals between the proximal section of the tubular structure and the distal section of the tubular structure via the guidewire.

[0015] In some embodiments, the proximal power and data coupling device, the distal power and data coupling device, or both, are configured to conductively couple to the guidewire by direct contact with the guidewire, hi some embodiments, the proximal power and data coupling device, the distal power and data coupling device, or both, are configured to conductively couple to the guidewire by capacitive coupling.

[0016]

[0016] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0017]

[0017] Additional features and advantages will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the teachings herein. The features and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. The features of the invention will become more fully apparent from the following description and the appended claims, or may be learned by the practice of the invention as set forth hereinafter.

[0018] Various objects, features, characteristics and advantages of the present invention will become apparent and be more readily understood from the following description of embodiments taken in conjunction with the accompanying drawings and the appended claims, all of which form a part of this specification, in which the same reference numerals may be utilized to designate corresponding or similar parts in the various views, and in which the various elements shown are not necessarily drawn to scale. [Brief description of the drawings]

[0019] [Figure 1]

[0019] A diagram showing components of a power and data coupling device and indicating that the coupling device can be communicatively coupled to an external device, illustrating a guidewire system configured to provide one or more of the features described in this specification. [Diagram 2]

[0020] FIG. 1 illustrates a catheter system configured to provide one or more of the features described herein, showing components of a power and data coupling device and indicating that the coupling device can be communicatively coupled to an external device. [Diagram 3]

[0021] FIG. 1 is an enlarged view of a distal section of the catheter to better illustrate an exemplary sensor placement on the catheter. [Figure 4]

[0022] FIG. 1 illustrates a catheter system having components that enable powering and data collection from one or more sensors positioned in the distal segment using a conductive guidewire threaded through the lumen of the catheter. [Figure 5A]

[0023] FIG. 1 shows an exemplary sensor substrate and arrangement in which such a substrate can be used to position a sensor on a catheter. [Figure 5B] FIG. 1 shows an exemplary sensor substrate and arrangement in which such a substrate can be used to position a sensor on a catheter. [Figure 5C] FIG. 1 shows an exemplary sensor substrate and arrangement in which such a substrate can be used to position a sensor on a catheter. [Figure 5D] FIG. 1 shows an exemplary sensor substrate and arrangement in which such a substrate can be used to position a sensor on a catheter. [Figure 5E] FIG. 1 shows an exemplary sensor substrate and arrangement in which such a substrate can be used to position a sensor on a catheter. [Figure 6]

[0024] Figure 6A illustrates a process for applying a sensor substrate to a distal section of a catheter; Figure 6B illustrates a process for applying a sensor substrate to a distal section of a catheter; Figure 6C illustrates a process for applying a sensor substrate to a distal section of a catheter; and Figure 6D illustrates a process for applying a sensor substrate to a distal section of a catheter. [Figure 7]

[0025] FIG. 2 is a detailed view of an exemplary ultrasound array that may be utilized in a catheter. [Figure 8A]

[0026] FIG. 2 is a detailed diagram of an exemplary proximal power and data coupling device for use in the proximal section of a catheter. [Figure 8B] FIG. 2 is a detailed diagram of an exemplary proximal power and data coupling device for use in the proximal section of a catheter. [Figure 8C]

[0027] FIG. 2 is a detailed diagram of an exemplary distal power and data coupling device for use in the distal section of a catheter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] Overview of the Intracavity System

[0028] FIG. 1 shows a schematic diagram of a guidewire system 100 that may incorporate one or more of the features described herein. The guidewire system 100 includes a wire 102 that is routeable through a proximal device 104. The wire 102 of the guidewire system 100 is configured to be inserted into a patient's body. The patient is typically a human, but in other implementations may be a non-human mammal, or even a non-mammalian animal. Any suitable route of administration may be utilized, depending on the particular preference and / or needs of the application. Common routes include femoral, radial, and jugular, although the guidewire system 100 may utilize other access routes as needed.

[0021]

[0029] While many of the examples described herein relate to the use of guidewire system 100 or catheter system 200 (see FIG. 2) in connection with intravascular procedures (e.g., cardiovascular or neurovascular), it will be appreciated that the described systems may be utilized in other medical applications as well. Other medical applications in which the systems described herein may be utilized include, for example, applications involving access to the lymphatic, urinary / renal, gastrointestinal, reproductive, hepatic, or respiratory systems.

[0022]

[0030] Here, the proximal device 104 is shown as a hemostatic valve, although in other embodiments, the proximal device 104 may include additional or alternative forms. The proximal device 104 may also be referred to herein as a "data and power coupling device 104" or simply as a "coupling device 104."

[0023]

[0031] The length of the wire 102 may vary depending on the needs of a particular application and the anatomical area being targeted. By way of example, the wire 102 may have an overall length from proximal to distal end of about 50 cm to about 350 cm, more typically about 200 cm, depending on the needs of a particular application and / or the particular anatomical target. The wire 102 may be sized such that the outer diameter (e.g., after application of other outer members) is about 0.008 inches to about 0.040 inches, although larger or smaller sizes may be utilized as needed for a particular application. For example, certain embodiments may have outer diameter sizes that correspond to standard guidewire sizes, such as 0.010 inches, 0.014 inches, 0.016 inches, 0.018 inches, 0.024 inches, 0.035 inches, 0.038 inches, or other such sizes common to guidewire devices. The wire 102 may be formed from stainless steel or other metals or alloys having suitable mechanical properties. Additionally or alternatively, the wire 102 may be formed from a conductive material having suitable mechanical properties. In some embodiments, the wire 102 may be formed from or include a conductive polymer.

[0024]

[0032] The coupling device may also include or be associated with a transmitter to enable wireless communication between guidewire system 100 and external device 110 (or multiple such external devices). In alternative embodiments, guidewire system 100 and external device 110 may be connected via a wired connection.

[0025]

[0033] The external device 110 can be a handheld device, such as a mobile phone, tablet, or laptop computer. While exemplary embodiments using a handheld or mobile device as the external device 110 are described herein, it will be understood that this is not necessary and other embodiments can include other "non-mobile" devices, such as desktop computers, monitors, projectors, etc. In some embodiments, the external device 110 includes a mobile / handheld device and additionally includes a desktop device or other non-mobile device. For example, a mobile device can be configured to act as a bridge by receiving data transmitted from a transmitter and further transmitting the data to a non-mobile computer system. This can be useful in situations where a physician would prefer the option of viewing data on a mobile device, but additionally or alternatively needs to have the data passed or mirrored on a larger monitor, such as when hands are full (e.g., when handling the guidewire system 100).

[0026]

[0034] The external device 110 of the guidewire system 100 can assist the physician in determining the location of the distal tip of the wire 102 within a blood vessel or other targeted anatomical structure of the human body. In this way, the physician can also obtain data of various parameters at the targeted anatomical structure while properly positioning the wire 102, thus enabling the physician to better understand the relevant environment and make appropriate decisions while treating the patient.

[0027]

[0035] The wireless systems of guidewire system 100 and catheter system 200 may include, for example, a personal area network (PAN) (e.g., very high frequency radio communication, such as Bluetooth, ZigBee, BLE, NFC, etc.), a local area network (LAN) (e.g., WiFi), or a wide area network (WAN) (e.g., cellular networks, such as 3G, LTE, 5G, etc.). Wireless data transmission may additionally or alternatively include the use of optical signals (infrared, visible radio, with or without the use of fiber optic lines), such as radio frequency (RF) sensors, infrared signals, or other wireless data transmission means.

[0028]

[0036] As used herein, both "electrical signal" and "signal" generally refer to any signal within the scope of the disclosed systems, devices, or methods. Meanwhile, a "sensor data signal," "sensor signal," or "data signal" refers to any signal that carries commands or information generated by a medical device, such as a medical sensor. In contrast, a "power signal" or "energy signal" refers to any signal that provides power to a medical device, such as a sensor. In some cases, a "signal" can include both a data signal and a power signal.

[0029]

[0037] Processing of the sensor data signals may be performed in whole or primarily at external device 110, or alternatively, may be performed at least in part at one or more other external devices communicatively connected to external device 110, such as a remote server or distributed network. Additionally or alternatively, the sensor data signals may be processed at coupling device 104 or 204, on wire 102 or catheter 202, or in some combination of devices within guidewire system 100 or catheter system 200. The sensor data signals may include, for example, image data, location data, and / or various types of sensor data (related to fluid flow, fluid pressure, presence / levels of various gases or biological components, temperature, other physical parameters, etc.).

[0030]

[0038] The one or more sensors may be coupled to the wire 102, and the one or more sensors may be operable to transmit a data signal through the wire 102 to the coupling device 104. Additionally or alternatively, the coupling device 104 may be operable to transmit power or a signal to the one or more sensors.

[0031]

[0039] As shown, guidewire system 100 includes a control unit 112 (shown in expanded schematic form), which includes a power source 114, a data signal processor 116, and optionally a transmitter 118. Transmitter 118 enables wireless communication to an external device 110 (or multiple such devices), as described above.

[0032]

[0040] The data signal processor 116 is configured to receive sensor data signals transmitted through the wire 102 from one or more sensors 121 associated with the wire 102. The power source 114 is configured to transmit power through the wire 102 to power the one or more sensors 121 and / or other components of the wire 102. The power source 114 may include an internal power source, such as a battery or battery pack, and / or may include a wired connection to an external power source. The one or more sensors 121 may be positioned at any suitable location on the wire 102, but are typically positioned at a distal section expected to reach the targeted anatomical structure.

[0033]

[0041] The guidewire system 100 is configured to transmit these power and data signals through the actual wire 102 itself, and does not require additional traces / leads to transmit signals from the distal section to the proximal section and vice versa. Using the wire 102 itself to transmit power and / or data signals through the device provides several benefits. For example, using the wire 102 to transmit these signals reduces or eliminates the need to run other connecting lines along the wire 102 to connect the sensor 121 to the proximal end and / or to deliver power to the sensor. Considering that guidewires inherently come with strict dimensional and performance (e.g., torqueability, bending, pushability, stiffness, etc.) limitations and limited space to work with, the ability to reduce or eliminate extra components frees up limited space and allows for further design flexibility. Reducing or eliminating the use of additional connecting lines also reduces the overall complexity of the device, thereby reducing the risk of component failure and resulting in a more robust functioning device.

[0034]

[0042] FIG. 2 is an overview of a catheter system 200 that may incorporate one or more of the features described herein. The catheter system 200 may be similar in many respects to the guidewire system 100, and the above description relating to the guidewire system 100 is also applicable here, except where differences are noted. The catheter system includes a catheter 202 extending from a proximal end 206 to a distal end 208. The catheter 202 may include one lumen or multiple lumens. Typically, the catheter 202 is formed at least primarily from one or more medical grade polymeric materials, although some embodiments may include other materials, such as metals. For example, as used herein, the term catheter 202 may refer to other medical devices comprising an elongated tubular structure and having one or more lumens, configured to be inserted into the body, including hypotubes or micromachined tubes, unless otherwise specified. In some embodiments, the catheter system 200 may include one or more nested catheters (e.g., arranged in a "telescopic" configuration). The separate layers may include, for example, braided layers, liners, polymeric coatings, other catheter layers, or combinations thereof, as known in the art.

[0035]

[0043] The catheter system 200 includes a catheter 202 and a proximal device 204 (sometimes referred to herein as a "proximal power and data coupling device 204" or simply "proximal coupling device 204"). The proximal coupling device 204 includes a control unit 212 (shown in expanded schematic form), which includes a power source 214, a data signal processor 216, and optionally a transmitter 218. The transmitter 218 enables wireless communication to an external device 110 (or multiple such devices), as described above with respect to FIG. 1.

[0036]

[0044] The data signal processor 216 is configured to receive sensor data signals transmitted through the catheter 202 from one or more sensors 221 associated with the catheter 202. The power source 214 is configured to transmit power through the catheter 202 to power the one or more sensors 221 and / or other components of the catheter 202. The power source 214 may include an internal power source, such as a battery or battery pack, and / or may include a wired connection to an external power source. The one or more sensors 221 may be located at any suitable location on the catheter 202, but are typically located at a distal section of the catheter 202 that is expected to reach the targeted anatomical structure. As used herein, "distal section" refers to the most distal 30 cm of the device, the most distal 20 cm of the device, the most distal 15 cm of the device, the most distal 10 cm of the device, or a range using any two of the above values ​​as endpoints.

[0037]

[0045] The sensor 221 may be coupled to the catheter 202 (e.g., the distal section of the catheter 202) by using, for example, bonding, molding, co-extrusion, welding, and / or adhesive techniques. Additionally or alternatively, the sensor 221 may be coupled to a substrate, which itself is attached to the catheter 202, as described in more detail below. As used herein, a "distal section" or "distal portion" refers to the most distal 30 cm of the device, the most distal 20 cm of the device, the most distal 15 cm of the device, the most distal 10 cm of the device, or a range using any two of the above values ​​as endpoints. In some embodiments, the "middle section" may be considered to be approximately the middle third of the device, and the "proximal section" or "proximal portion" may be considered to be approximately the proximal third of the device.

[0038]

[0046] In some embodiments, the power and / or data lines 201 extend along the length of the catheter 202 to one or more sensors 221. In some embodiments, one or more power and / or data lines 201 can be incorporated into or form at least a portion of the braided structure in the catheter 202. As used herein, "power line" and / or "data line" refer to any conductive path (e.g., trace) in a medical device. While multiple power and / or data lines 201 can be utilized, more preferred embodiments are configured to transmit both power and data over a single wire and / or manage sensor data signals from multiple sensors over a single wire. This reduces the number of wires that must be routed through (or along) the structure of the catheter 202, more effectively utilizing the limited space in the device, as well as reducing device complexity and the associated risk of device failure.

[0039]

[0047] In some embodiments, multiple power and / or data signals (e.g., data signals from multiple sensors 221) may be transmitted simultaneously over line 201. The power and / or data signals may also be transmitted "continuously", i.e., the power and / or data signals may have a high enough sampling rate such that information is provided to a user within a time frame that is effectively "real time". In most applications, this includes sampling rates of about 5 seconds or less, 3 seconds or less, 1 second or less, or even sampling rates less than 1 second.

[0040]

[0048] The proximal coupling device 204 may include one or more ports to facilitate the introduction of fluids (e.g., medications, nutrients) into the catheter 202. The catheter 202 may be sized and configured to be temporarily inserted into the body, may be sized and configured to be permanently implanted into the body, or may be configured to deliver an implant into the body. In one embodiment, the catheter 202 is a peripherally inserted central catheter (PICC) line, typically placed in an arm or leg of the body to access the vascular system of the body. The catheter 202 may also be a central venous catheter, an IV catheter, a coronary artery catheter, a stent delivery catheter, a balloon catheter, an atherectomy catheter, or an IVUS catheter, or other imaging catheter. The catheter 202 may be a single or multi-lumen catheter.

[0041]

[0049] Applications in which localization of the distal section of the system would be beneficial may effectively utilize guidewire system 100 and / or catheter system 200. For example, the localization features described herein may be utilized to aid in stent delivery or proper placement of a PICC catheter or central venous catheter to a targeted site, such as the caval-atrial junction. Additional Sensor Details

[0050] The sensor(s) 121 of the guidewire system 100 and / or the sensor(s) 221 of the catheter system 200 may include, for example, a pressure sensor, a flow sensor, an imaging sensor, or a component detection sensor. The pressure sensor(s) may be sized and configured to sense changes in pressure in the environment. The flow sensor(s) may be sized and configured to sense fluid flow, such as velocity or other flow characteristics. The detection sensor(s) may detect proximity or distance to one or more detection nodes positioned outside the body. The imaging sensor may gather various forms of imaging data.

[0042]

[0051] The one or more sensors may additionally or alternatively be configured to sense the presence of a biological component or measure a physiological parameter within the targeted anatomical location (e.g., blood). Examples of biological components that may be detected / measured include blood glucose levels, pH levels, CO2 levels (CO2 partial pressure, bicarbonate levels), oxygen levels (oxygen partial pressure, oxygen saturation), temperature, and other such substrates and physiological parameters. The one or more sensors may be configured to monitor, for example, immune system related molecules (e.g., macrophages, lymphocytes, T cells, natural killer cells, monocytes, other white blood cells, etc.), inflammatory markers (e.g., C-reactive protein, procalcitonin, amyloid A, cytokines, α1-acid glycoprotein, ceruloplasmin, hepcidin, haptoglobin, etc.), platelets, hemoglobin, ammonia, creatinine, bilirubin, homocysteine, albumin, lactate, pyruvate, ketone bodies, ion and / or nutrient levels (e.g., glucose, urea, chloride, sodium, potassium, calcium, iron / ferritin, copper, zinc, magnesium, vitamins, etc.), hormones (e.g., estradiol, The sensors may be configured to sense the presence, absence, or levels of biological constituents, such as steroid hormone, follicle stimulating hormone, aldosterone, progesterone, luteinizing hormone, testosterone, thyroxine, thyrotropin, parathyroid hormone, insulin, glucagon, cortisol, prolactin, etc.), enzymes (e.g., amylase, lactate dehydrogenase, lipase, creatine kinase), lipids (e.g., triglycerides, HDL cholesterol, LDL cholesterol), tumor markers (e.g., α-fetoprotein, β-human chorionic gonadotropin, carcinoembryonic antigen, prostate specific antigen, calcitonin), and / or toxins (e.g., lead, ethanol). Catheter Sensor Placement and Distal Features

[0052] FIG. 3 shows an expanded view of the distal section of the catheter system 200, illustrating various sensors disposed on the catheter system 200. In this embodiment, the one or more sensors 221 (more diagrammatically shown in FIG. 2) include a number of pressure sensors 220 and an ultrasound sensor 222. As described above, the sensors can be attached to the catheter 202 by embedding within the catheter 202, attaching with an adhesive, and / or other attachment means. In this example, the sensors are positioned on a substrate 224, which is positioned on the catheter 202 to place the sensors at their desired locations. The substrate 224 can be made of a somewhat flexible material (e.g., a suitable medical grade polymer) that allows the substrate 224 to be wrapped around the catheter 202, or otherwise positioned on the catheter 202. The substrate 224 also includes a flexible circuit, such as trace lines and / or one or more conductive contacts, for conductively coupling the sensors to the catheter 202. The substrate 224 may form a friction fit with the catheter 202 and may additionally or alternatively be glued or otherwise mechanically joined to the catheter 202 .

[0043]

[0053] Bonding the sensors to the substrate 224 and then placing the substrate 224 on the catheter 202 provides several benefits. For example, the substrate 224 can be essentially laid out in a two-dimensional layout, making it much easier to properly position the sensors. The two-dimensional substrate 224 with the sensors bonded to it can then be placed on the three-dimensional cylindrical catheter 202 more easily than if each sensor was placed on the catheter 202 separately. In particular, it is easier to ensure that the various sensors are properly positioned relative to each other on the substrate 224 and then position the substrate 224 on the catheter 202 than trying to control the relative spacing of each sensor on the three-dimensional cylindrical catheter 202. Alternatively, the various sensors can be placed on the substrate after the substrate is applied to the three-dimensional catheter 202.

[0044]

[0054] The illustrated embodiment also includes an energy harvester 232. The energy harvester is configured to convert the injected power into a regulated DC voltage suitable for the sensor. The energy harvester 232 can also provide other electrical conditioning functions, such as, for example, cutting power to the sensor during a fault or power saving. Additionally, the energy harvester 232 is considered to be a subcomponent of the sensor(s) 221, unless otherwise specified herein. Thus, unless otherwise stated, references to the sensor(s) 221 also refer to associated circuitry, such as the energy harvester 232.

[0045]

[0055] Additionally, in at least one embodiment, the energy harvester 232 is configured to provide a control function for the one or more sensors 221. For example, a specific signal can be communicated from the power and data coupling device 204 to the energy harvester 232. The specific signal can include a chirp, an impulse function, or some signal on a specific frequency channel. The energy harvester 232 maps the specific signal to a predefined command and then acts on the predefined command. For example, the specific signal can be mapped to a command to disconnect DC power to one or more rails powering the one or more sensors 221. Thus, upon receiving the specific signal, the energy harvester 232 stops providing power to the one or more sensors 221, thereby turning off the one or more sensors 221. Any number of different signals can be mapped to any number of different commands. Additionally, in at least one embodiment, circuitry other than the energy harvester 232 receives, interprets, and / or acts on the signal.

[0046]

[0056] Unless otherwise stated, it should be understood that when referring to sensors (either generically or to a specific type of sensor), the support electronics are included as well. The support electronics may include, for example, power conditioners, converters, signal amplifiers, processing components such as application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), and the like. The support electronics for the sensor(s) 221 are preferably positioned near the sensor(s) 221 themselves (e.g., in the distal section and / or substrate 224). This has been found to be beneficial in reducing signal drift compared to placing the support electronics in the proximal section of the device. Placing the support electronics (e.g., ASICs) in the distal section near the sensor 221 provides effective signal transmission without the significant drift issues of other approaches.

[0047]

[0057] The length of the catheter 202 including the substrate 224 (and thus the sensor) can be about 3 cm to about 30 cm, or more typically about 5 cm to about 15 cm, although these lengths can be modified as needed for a particular application. The length of the sensor arrangement preferably spans substantially the expected length of the lesion / stenosis in the target anatomy. A linear arrangement of pressure sensors 220 can be used to provide pressure mapping of the targeted anatomy without the need to move the catheter 202. Multiple measurements from multiple sensors can be taken simultaneously and / or sequentially. The arrangement of pressure sensors 220 can also be used to measure pulse wave velocity (PWV) (e.g., by determining a series of wave peaks and measuring the time between the peaks) and / or provide spatial tracking of the pulse waveform. Catheter power and data transmission using a separate guidewire - Patents.com

[0058] 4 illustrates a catheter system 200 in a configuration that allows one or more sensors 221 to be powered and / or pass data signals using a conductive guidewire 101 threaded through the lumen of the catheter 202. The guidewire 101 can correspond to the guidewire system 100 described above or can take the form of other guidewires known in the art so long as the guidewire 101 is capable of carrying electrical signals. In certain embodiments in which the catheter 202 is configured to use the guidewire 101 to transmit power and / or data, the other power and / or data lines 201 can be omitted. In other words, the catheter 202 can be configured such that the guidewire 101 is the only wire or line required to transmit power and / or data signals.

[0048]

[0059] As shown, a catheter 202 can be routed over a guidewire 101. Both the guidewire 101 and the catheter 202 are routed through a proximal coupling device 204. One or more sensors 221 are disposed in a distal section of the catheter 202. A distal power and data coupling device 205 (also referred to as a "distal coupling device 205") is also disposed in the distal section of the catheter 202 and is in electrical communication with the one or more sensors 221. Both the proximal coupling device 204 and the distal coupling device 205 are configured to conductively couple to the underlying guidewire 101.

[0049]

[0060] The use of guidewire 101 as a means for transmitting power and / or data reduces or eliminates the need for various power and / or data lines (see power and / or data lines 201 in FIG. 2) for transmitting power and / or data along the catheter 202. Because such power and / or data lines 201 must be routed along the length of the catheter 202 or embedded in the wall of the catheter 202, the shape and mechanical properties of the catheter 202 must take into account these additional constraints, making manufacturing concomitantly more difficult. Similarly, the use of guidewire 101 as a means for transmitting power and / or data reduces the number of components at risk of failure or malfunction during use of the catheter 202, thereby providing a robust system for transmitting power to and receiving data signals from the sensor 221.

[0050]

[0061] The conductive coupling between the coupling devices 204, 205 and the guidewire 101 can be achieved by direct contact between the coupling devices 204, 205 and the underlying guidewire 101. For example, the inner surface of one or both of the coupling devices 204, 205 can be sized to directly contact the guidewire 101 when the catheter 202 is threaded over the guidewire 101.

[0051]

[0062] In more preferred embodiments, direct contact with the underlying guidewire 101 is not required. As described in more detail below, in some embodiments, the proximal coupling device 204, the distal coupling device 205, or both, are configured to capacitively couple to the underlying guidewire 101. This type of coupling further reduces or eliminates the need for various power and / or data lines 201 to transmit power and / or data along the catheter 202. Capacitive coupling also eliminates the need to form direct contact between the inner surface of the coupling devices 204, 205 and the outer surface of the guidewire 101, which increases the risk of friction and binding between the catheter 202 and the guidewire 101. In other embodiments, the proximal coupling device 204 can be directly coupled to the catheter 202 (without necessarily requiring the guidewire 101 for conductive coupling) to transmit power and / or data. In such embodiments, the distal coupling device 205 is not necessarily required. Application to sensor substrates and catheters

[0063] As discussed above, one or more sensors 221 may be coupled to the catheter 202 by embedding into the structure of the catheter 202, attaching with an adhesive, and / or other sensor attachment methods known in the art. In another example, the exterior surface of the catheter 202 may be etched or grooved and filled with a material (e.g., a conductive polymer) that forms suitable conductive traces to which the one or more sensors 221 may be associated. An outer layer may then be applied at least partially over the traces and / or sensors 221 to embed the components into the wall of the catheter 202.

[0052]

[0064] Described below are alternative methods of mounting one or more sensors 221 that may be used in addition to or as an alternative to the other sensor mounting methods described herein.

[0053]

[0065] 5A-5E show additional exemplary configurations of the substrate 224. FIG. 5A provides an example of a substrate 224 having a structure that allows for a spiral wrapping of the catheter 202, similar to that shown in FIG. 3. FIG. 5B shows an example of a substrate 224 having a cut or split in its structure. The substrate 224 of FIG. 5B can also be positioned around the catheter 202 until an edge meets or overlaps the cut / split. Alternatively, the substrate 224 of FIG. 5B can form a "clamshell" structure in which two halves are placed over the catheter 202 and then joined and / or held in place by an overlying outer member. While the cut / split shown is longitudinal, other embodiments can include other cuts / splits of other shapes, including transverse, curved, spiral, etc. In some embodiments, the cut / split allows for matching interlocks and / or a set of edges that are configured to engage with each other when joined together.

[0054]

[0066] Figure 5C shows an example of a substrate 224 having a tubular structure with a cut pattern 538 that allows the tube to be manipulated for placement over the catheter 202. Figure 5C shows a helical cut pattern. Other embodiments may additionally or alternatively include other cut patterns (e.g., a series of longitudinal and / or transverse cuts) that allow the tube to be manipulated to allow placement over the catheter 202. However, the cut patterns 538 are preferably distributed circumferentially around the tube to avoid formation of preferred bending planes within the tube.

[0055]

[0067] 5D and 5E provide an example of how the substrate 224 can be manipulated during placement onto the catheter 202. FIG. 5D shows the tube structure of the substrate 224 in its default state. By appropriately twisting the end of the tube, as shown in FIG. 5E, the tube shortens longitudinally and expands radially. In the radially expanded position, the tube can fit over the catheter 202 and be positioned at a desired location. When the twisting force is removed, the tube then returns to the default position of FIG. 5D, thereby tightening around the catheter 202. In some embodiments, the tube can be tightened sufficiently to form a friction fit around the catheter 202. As discussed above, adhesive bonding and / or placement of the outer member can additionally or alternatively function to hold the substrate 224 in place.

[0056]

[0068] 6A-6D show a sequence of steps for applying a sensor substrate 224 to a catheter 202. In this example, the substrate 224 has the form of a strip configured to be wrapped in a spiral shape around the catheter 202 (similar to the embodiment shown in FIG. 5A). FIG. 6A shows the substrate 224 disposed in a flat position. The substrate 224 includes a base material 636 (e.g., a suitable medical grade polymer) and conductive traces 634. The conductive traces 634 may include, for example, standard conductive copper traces and / or other conductive material embedded in or otherwise attached to the base material 636.

[0057]

[0069] In some embodiments, a conductive polymer can be utilized to form the conductive traces 634. For example, the base material 636 can be cut, grooved, or otherwise prepared to receive the conductive polymer at the desired locations, and then the conductive polymer can be applied and allowed to harden (if desired) to form the conductive traces 634. A similar process can be applied to the exterior surface of the catheter 202 itself, without the need for a substrate 224.

[0058]

[0070] The conductive traces 634 provide conductive contacts for a sensor (e.g., pressure sensor 220 as shown, although other sensor types described herein may additionally or alternatively be used) so that the sensor 220 can be placed in conductive communication with other underlying components of the catheter 202 after the substrate 224 is applied to the catheter 202. The conductive traces 634 may be formed as one or more continuous and uninterrupted lines, as shown. Alternatively, one or more individual sections of conductive material may be included within the substrate 224, so long as each of those sections is somehow positioned in conductive communication with the underlying structure for corresponding placement of the sensor.

[0059]

[0071] As shown in Figure 6B, the sensor 220 is positioned such that it is rotationally offset from the longitudinal axis of the planar substrate 224. This allows the sensor to be aligned with the longitudinal axis of the catheter 202 when the substrate 224 is helically wrapped around the catheter 202, as shown in Figure 6C. This type of offset may not be necessary for certain sensor types (e.g., radially symmetric sensors), but can be utilized when the orientation of the sensor relative to the catheter 202 is important. The offset angle can be, for example, about 10 to 35 degrees from the longitudinal axis, although other offset angles can be utilized depending on factors such as the wrap angle of the substrate 224 when applied to the catheter 202, the desired final orientation of the sensor 220, etc.

[0060]

[0072] The spacing of the sensors 220 on the substrate 224 and / or the wrap angle when applying the substrate 224 to the catheter 202 can also be modified to adjust the resulting position and spacing of the sensors 220 relative to the underlying catheter 202. For example, the illustrated embodiment shows each successive sensor 220 circumferentially offset by approximately 120 degrees from the adjacent sensor. Other circumferential offset angles can also be utilized according to design preference and / or needs of a particular application. A preferred embodiment includes some form of circumferential offset to better space the sensors 220 around the circumference of the device and thus better eliminate circumferential position as a variable in the overall sensor reading.

[0061]

[0073] 6D shows application of outer member 226 over substrate 224. Outer member 226 may be applied using shrink tubing, dip coating, and / or other means of applying polymeric coatings to catheters known in the art. For purposes of illustration, sensor 220 is shown slightly above the outer surface of outer member 226. In most embodiments, sensor 220 is substantially flush with the outer surface of outer member 226. Imaging function

[0074] The catheter system 200 can include one or more sensors for providing imaging. Figure 7 shows an example of an ultrasonic sensor 222. As with other sensors described herein, the ultrasonic sensor 222 can be disposed on a substrate 224, which is then positioned on the catheter 202, or the ultrasonic sensor 222 can be directly embedded in the catheter 202, for example. The illustrated ultrasonic sensor 222 includes one or more (preferably multiple) micromachined capacitive ultrasonic transducers (CMUTs) 742 and corresponding supporting electronics in the form of a complementary metal oxide semiconductor (CMOS) chip 740. In the illustrated embodiment, each CMUT 742 is associated with its own CMOS chip 740 in a paired 1:1 relationship. Each CMUT 742 and CMOS chip 740 pair functions independently to transmit data signals through the catheter 202, without requiring any of the CMOS chips 740 to multiplex multiple signals from separate CMUTs 742.

[0062]

[0075] The ultrasonic sensor 222 of the catheter system 200 can be configured to operate at any suitable set of frequencies. In some embodiments, the ultrasonic sensor 222 can operate at a center frequency of about 10 to about 80 MHz, about 15 to about 60 MHz, about 20 to about 50 MHz, or any other range using any two of the above values ​​as endpoints.

[0063]

[0076] Some embodiments of the catheter system 200 may additionally or alternatively include other imaging sensors. For example, the catheter system 200 may include a camera device configured to capture various types of imaging data, including pixel arrays, images, videos, or other types of imaging data. The catheter system 200 may include any imaging device known in the art suitable for positioning at or integration with the distal portion of the system, including fiber optic cameras, LIDAR systems, Raman scattering systems, optical coherence tomography (OCT), mm-wave cameras, infrared imaging systems, other imaging devices / systems known in the art, or combinations thereof. Image data collected by such imaging devices may be modified using one or more image enhancement algorithms known in the art. Power and Data Coupling Devices

[0077] As discussed above (see FIG. 4 and associated discussion), the catheter system 200 may include a proximal coupling device 204 and a distal coupling device 205 that function together to transmit power and / or data along the catheter 202 using the underlying guidewire 101, thus minimizing or eliminating the need for power and / or data wires 201 extending over a significant length of the catheter 202. Thus, in some embodiments, a single power and data coupling device may be utilized, and in some embodiments, a pair of power and data coupling devices may be utilized. Some embodiments may include more than two power and data coupling devices. For example, in some embodiments, multiple guidewires and / or catheter members may be utilized (e.g., a procedure targeting coronary lesions located at a vessel bifurcation), with multiple such members including one or more power and data coupling devices.

[0064]

[0078] 8A provides a detailed view of an exemplary proximal power and data coupling device 204. Although the proximal coupling device 204 is shown here as a hemostatic valve, the components and associated functions of the proximal coupling device 204 described herein may be provided by other structures (e.g., dilators, ports, insertion needles, syringes) that do not necessarily provide valve functionality. However, because hemostatic valves are prevalent in guidewire applications, integrating the components of the proximal coupling device 204 into a hemostatic valve is a beneficial implementation.

[0065]

[0079] The depicted proximal coupling device 204 includes a body 844 housing a power source in the form of a battery 846 (corresponding to power source 214 of FIG. 2) and a transmitter 218. The proximal coupling device 204 may additionally or alternatively include a wired power connection 847, although in a preferred embodiment the use of additional wiring is minimized. The proximal coupling device 204 also includes a first proximal conductive surface 850 (in this example in the form of a conductive tube) positioned for the guidewire 101 to pass through as it is inserted and translated through the proximal coupling device 204. Thus, FIG. 8A illustrates an over-the-wire catheter application in which the catheter 202 may be passed over the guidewire 101 through the proximal coupling device 204. In such an over-the-wire coupling, the catheter 202 encloses the guidewire 101 at least from the power and data coupling device 204 to a distal portion of the catheter 202. In such an embodiment, the catheter 202 is configured to minimize or avoid interference with the capacitive coupling between the proximal coupling device 204 and the guidewire 101. This can be accomplished, for example, by including holes or other openings in the conductive surface (e.g., sized to match the frequency meant to carry the signal, thereby allowing coupling through a gap), and ensuring that the surface of the catheter 202 does not completely surround the guidewire 101.

[0066]

[0080] 8B, on the other hand, illustrates the proximal coupling device 204 in a "rapid-exchange" catheter application. In this application, the portion of the catheter 202 that passes through the proximal coupling device 204 can be adjacent to the guidewire 101 rather than over the guidewire 101. The rapid-exchange coupling includes a distal portion of the catheter 202 that surrounds the guidewire 101 and a proximal portion of the guidewire 101 that extends adjacent to the proximal portion of the catheter 202. In either the over-the-wire or rapid-exchange configuration, the power and data coupling device 204 is configured to couple to a conductive surface in the guidewire 101 and / or a conductive surface in the catheter 202.

[0067]

[0081] The depicted proximal coupling device 204 is configured to function as a capacitive coupler that allows for connection and disconnection of power and / or data transmission to the catheter 202 without requiring direct contact with the catheter 202 or the guidewire 101 (through the guidewire 101 in the particular example shown in FIG. 8B . In other embodiments, the guidewire 101 is not necessarily required to transmit power and / or data, e.g., one or more power and / or data lines 201 may be used to transmit power and / or data). In particular, the first proximal conductive surface 850 functions as a first conductive surface configured to couple to a second conductive surface (i.e., a portion of the guidewire 101). In operation, the first proximal conductive surface 850 includes (or is connected to) pickups configured to emit a time-varying electric field to carry power to the guidewire 101 and receive data signals from the guidewire 101 and / or the catheter 202. Capacitive coupling can be established without the need for particularly high voltages (e.g., 5 to 12 volts is typically sufficient) because the space between the outer surface of the guidewire 101 and the inner portion of the first proximal conductive surface 850 is filled with blood, which typically has a relatively high electrical conductivity. The first proximal conductive surface 850 is communicatively connected to a transmitter 218 such that data signals can be transmitted from the coupling device 204 to one or more external devices 110 (see FIG. 2).

[0068]

[0082] Although the embodiment shown includes a first proximal conductive surface 850 in the form of a tube, other embodiments may include a first conductive surface in the form of one or more plates, other concentric or partially concentric shapes, or other shapes capable of making sufficient electrical contact with the guidewire 101. The proximal coupling device 204 may include one or more additional supporting electronic components, such as an amplifier for amplifying the signal.

[0069]

[0083] 8C illustrates one embodiment of a distal coupling device 205 located at the distal section (near the distal end 208) of the catheter 202. The distal coupling device 205 may include similar components and features as the proximal coupling device 204 illustrated in FIG. 8A. The distal coupling device 205 includes a first distal conductive surface 851 (shown here in the form of a tube) through which the guidewire 101 passes, and may optionally include a power source (shown here in the form of a battery 849) to which the first distal conductive surface 851 is electrically connected. The first distal conductive surface 851 may alternatively be a plate, curved surface, or other shape suitable for use in the distal section of the catheter 202. The one or more sensors 221 are electrically connected to the first distal conductive surface 851 (e.g., by one or more connecting wires).

[0070]

[0084] The first distal conductive surface 851 of the distal coupling device 205 is similar to the proximal coupling device 204, but typically has signals traveling in the opposite direction, and operates to pick up power signals transmitted from the guidewire 101 and then transmit them to the one or more sensors 221. The first distal conductive surface 851 is also configured to receive data signals from the one or more sensors 221 and emit a time-varying electric field to carry corresponding data signals to the guidewire 101.

[0071]

[0085] Although the depicted distal coupling device includes a first conductive surface in the form of a first distal conductive surface 851, other embodiments may include a first conductive surface in the form of one or more plates, other concentric or partially concentric shapes, or other shapes capable of making sufficient electrical contact with the guidewire 101 at the distal section of the catheter 202. The distal coupling device 205 may include one or more additional supporting electronic components, such as an amplifier for amplifying the signal.

[0072]

[0086] When the catheter 202 is threaded over the guidewire 101 through the proximal coupling device 204, it does not significantly impede the electrical coupling between the first proximal conductive surface 850 and the guidewire 101. Although the catheter 202 passes between the outer surface of the guidewire 101 and the inner surface of the first proximal conductive surface 850, capacitive contact is maintained at a level that allows for continued transmission of power and data signals (e.g., by appropriate design of the catheter and / or geometry of the capacitive surface). In contrast, systems that require some type of wired connection to the wire to pass power and / or data must be temporarily disconnected when the catheter is routed over the guidewire. In addition to the complications associated with connecting and disconnecting the guidewire, this means that there is a moment when visualization and / or other data signals passing over the wire are stopped. On the other hand, the system 200 shown does not require an additional disconnect / reconnect step.

[0073]

[0087] The coupling devices 204, 205 can be configured to transmit power and data signals simultaneously. In some implementations, for example, the proximal coupling device 204 can provide multiple different power signals (e.g., each power signal configured to power a different sensor or set of sensors) to the guidewire 101 and / or receive multiple different data signals (e.g., each data signal from a different sensor or set of sensors) from the guidewire 101. Similarly, the distal coupling device 205 can provide multiple different data signals (e.g., each data signal from a different sensor or set of sensors) to the guidewire 101 and / or receive multiple different power signals (e.g., each power signal configured to power a different sensor or set of sensors) from the guidewire 101. Additional Computer System Details

[0088] Certain methods described herein can be implemented by a computer system including one or more processors and a computer-readable medium, such as a computer memory. In particular, the computer memory can store computer-executable instructions that, when executed by one or more processors, cause various functions to be performed, such as the operations described in the embodiments.

[0074]

[0089] The functionality of a computing system can be enhanced by the ability of the computing system to be interconnected to other computing systems through network connections, which may include, but are not limited to, connections via wired or wireless Ethernet, cellular connections, or even computer-to-computer connections through serial, parallel, USB, or other connections. These connections enable a computing system to access the services of the other computing systems and to receive application data from the other computing systems quickly and efficiently.

[0075]

[0090] The interconnection of computing systems has facilitated distributed computing systems, such as so-called "cloud" computing systems. In this description, "cloud computing" may be a system or resource that enables ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, services, etc.) that can be provisioned and exposed with reduced administrative effort or service provider interaction. Cloud models can be composed of a variety of characteristics (e.g., on-demand self-service, broad network access, resource pools, rapid scalability, measurable services, etc.), service models (e.g., Software as a Service ("SaaS"), Platform as a Service ("PaaS"), Infrastructure as a Service ("IaaS"), and implementation models (e.g., private cloud, community cloud, public cloud, hybrid cloud, etc.).

[0076]

[0091] Cloud and remote based service applications are also becoming popular. Such applications are hosted on remote systems, both public and private, such as clouds, and typically provide a set of web-based services to communicate bidirectionally with clients.

[0077]

[0092] Many computers are intended to be used by direct user interaction with the computer. Thus, computers have input hardware and software user interfaces to facilitate user interaction. For example, modern general-purpose computers may include a keyboard, mouse, touchpad, camera, etc. to allow a user to input data into the computer. Moreover, a variety of software user interfaces are also available.

[0078]

[0093] Examples of software user interfaces include graphical user interfaces, text command line based user interfaces, function key or hot key user interfaces, and the like.

[0079]

[0094] The disclosed embodiments may comprise or utilize a special-purpose or general-purpose computer, including computer hardware, as discussed in more detail below. The disclosed embodiments also include physical and other computer-readable media for carrying or storing computer-executable instructions and / or data structures. Such computer-readable media may be any available media that can be accessed by a general-purpose or special-purpose computer system. Computer-readable media that store computer-executable instructions are physical storage media. Computer-readable media that carry computer-executable instructions are transmission media. Thus, by way of example, but not limitation, embodiments of the present invention may include at least two distinctly different types of computer-readable media: physical computer-readable storage media and transmission computer-readable media.

[0080]

[0095] Physical computer-readable storage media include RAM, ROM, EEPROM, CD-ROM or other optical disk storage (CD, DVD, etc.), magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store desired program code means in the form of computer-executable instructions or data structures and that can be accessed by a general-purpose or special-purpose computer.

[0081]

[0096] A "network" is defined as one or more data links that enable the transport of electronic data between computer systems and / or modules and / or other electronic devices. When information is transferred or provided to a computer over a network or another communications connection (hardwired, wireless, or a combination of hardwired or wireless), the computer properly views the connection as a transmission medium. Transmission media can include networks and / or data links that can be used to carry program code in the form of computer-executable instructions or data structures and that can be accessed by a general-purpose or special-purpose computer. Combinations of the above are also included within the scope of computer-readable media.

[0082]

[0097] Furthermore, when reaching various computer system components, program code means in the form of computer-executable instructions or data structures can be automatically transferred from a transmission computer-readable medium to a physical computer-readable storage medium (or vice versa). For example, computer-executable instructions or data structures received over a network or data link can be buffered in RAM within a network interface module (e.g., a "NIC") and then eventually transferred to the computer system's RAM and / or to a computer system's low-volatility computer-readable physical storage medium. Thus, computer-readable physical storage media can be included within computer system components that also (or even primarily) utilize transmission media.

[0083]

[0098] Computer-executable instructions include, for example, instructions and data that cause a general purpose computer, special purpose computer, or special purpose processing device to perform a certain function or group of functions. Computer-executable instructions may be, for example, binaries, intermediate format instructions such as assembly language, or even source code. Although the subject matter has been described in language specific to structural features and / or methodological operations, it will be understood that the subject matter defined in the appended claims is not necessarily limited to the described features or operations. On the contrary, the described features and operations are disclosed as example forms of implementing the claims.

[0084]

[0099] Those skilled in the art will appreciate that the present invention may be practiced in a networked computing environment having many types of computer system configurations, including personal computers, desktop computers, laptop computers, message processors, handheld devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computers, mobile telephones, PDAs, pagers, routers, switches, etc. The present invention may also be practiced in a distributed system environment in which tasks are performed by both local and remote computer systems that are linked through a network (by hardwired data links, wireless data links, or a combination of hardwired and wireless data links). In a distributed system environment, program modules may be located in both local and remote memory storage devices.

[0085]

[0100] Alternatively or additionally, the functions described herein may be performed, at least in part, by one or more hardware logic components, for example, but not limited to, examples of types of hardware logic components that may be used include Field-programmable Gate Arrays (FPGAs), Program-specific Integrated Circuits (ASICs), Program-specific Standard Products (ASSPs), System-on-a-chip systems (SOCs), Complex Programmable Logic Devices (CPLDs), etc. Additional Exemplary Aspects

[0101] Embodiments of the present disclosure may include, but are not necessarily limited to, the features set forth in the following clauses.

[0086]

[0102] Clause 1: A medical device comprising: an elongated tubular structure for insertion into the body, the tubular structure having a proximal end, a distal end, and an internal lumen extending through the proximal and distal ends; one or more sensors of one or more sensor types coupled to a distal section of the tubular structure; one or more wires associated with the tubular structure, the one or more wires being electrically connectable to the one or more sensors; and a first power and data coupling device configured to be operably associated with the tubular structure, the first power and data coupling device configured to conductively couple to the one or more wires and to transmit and receive electrical signals through the one or more wires.

[0087]

[0103] Clause 2: The medical device described in clause 1, wherein the elongated tubular structure is configured as an over-the-wire catheter.

[0104] Clause 3: A medical device described in clause 1 or 2, wherein the elongated tubular structure is configured as a rapid exchange catheter.

[0088]

[0105] Clause 4: A medical device described in any one of clauses 1 to 3, wherein the one or more wires include one or more power and / or data lines disposed within a lumen or extending across or within a wall of the tubular structure between the first power and data coupling device and the one or more sensors.

[0089]

[0106] Clause 5: A medical device described in any one of clauses 1 to 4, wherein the one or more wires include a guidewire positionable within at least a portion of the lumen of the tubular structure.

[0090]

[0107] Clause 6: A medical device as described in clause 5, wherein the first power and data coupling device is a proximal power and data coupling device disposed in a proximal section of the tube structure.

[0108] Clause 7: The medical device of clause 6, further comprising a second distal power and data coupling device disposed in a distal section of the tube structure.

[0091]

[0109] Clause 8: A medical device as described in Clause 7, wherein the proximal power and data coupling device and the distal power and data coupling device are configured to conductively contact the guidewire when the guidewire is inserted through the lumen of the tube structure, thereby enabling passage of electrical signals between the proximal section of the tube structure and the distal section of the tube structure via the guidewire.

[0092]

[0110] Clause 9: The medical device of clause 8, wherein the proximal power and data coupling device, the distal power and data coupling device, or both, are configured to conductively couple to the guidewire by direct contact with the guidewire.

[0093]

[0111] Clause 10: The medical device of clause 8, wherein the proximal power and data coupling device, the distal power and data coupling device, or both, are configured to conductively couple to the guidewire by capacitive coupling.

[0094]

[0112] Clause 11: A medical device as described in clause 10, wherein the one or more sensors are electrically connected to a distal power and data coupling device at a distal section of the tubular structure.

[0113] Clause 12: A medical device described in any one of clauses 1 to 11, wherein the device is configured to transmit and receive electrical signals through a single wire.

[0095]

[0114] Clause 13: The medical device of any one of clauses 1 to 12, wherein the tube structure is configured as a peripherally inserted central catheter, a central venous catheter, or an intravenous catheter.

[0096]

[0115] Clause 14: A medical device described in any one of clauses 1 to 13, wherein the first power and data coupling device is configured to conductively couple to one or more wires by direct contact with the one or more wires.

[0097]

[0116] Clause 15: A medical device described in any one of clauses 1 to 14, wherein the first power and data coupling device is configured to conductively couple to one or more wires by capacitive coupling to the one or more wires.

[0098]

[0117] Clause 16: A medical device described in any one of clauses 1 to 15, wherein the one or more sensor types include two or more different sensor types.

[0118] Clause 17: A medical device described in any one of clauses 1 to 16, wherein the multiple sensors are configured to provide simultaneous measurement of one or more physiological parameters.

[0099]

[0119] Clause 18: A medical device described in any one of clauses 1 to 17, wherein the active sampling rate of one or more sensors is 5 seconds or less.

[0120] Clause 19: A medical device described in any one of clauses 1 to 18, wherein the one or more sensors include one or more pressure sensors.

[0100]

[0121] Clause 20: A medical device as described in Clause 19, wherein the one or more pressure sensors include resistive, capacitive, optical, acoustic, photoacoustic, or a combination thereof.

[0122] Clause 21: A medical device described in clause 19 or 20, wherein the device comprises a plurality of pressure sensors longitudinally spaced along the length of the distal section of the tube structure.

[0101]

[0123] Clause 22: A medical device described in any one of clauses 1 to 21, wherein the one or more sensors include one or more ultrasonic sensors, cameras, charge-coupled devices, or other imaging detectors.

[0102]

[0124] Clause 23: A medical device described in any one of clauses 1 to 22, wherein the electrical signal includes a power signal delivered to the one or more sensors through one or more wires to power the one or more sensors.

[0103]

[0125] Clause 24: A medical device described in any one of clauses 1 to 23, wherein the electrical signal comprises a data signal transmitted through one or more wires by one or more sensors as a result of operation of the one or more sensors.

[0104]

[0126] Clause 25: A medical device described in any one of clauses 1 to 24, wherein one or more sensors are at least partially embedded in the wall of the tubular structure.

[0127] Clause 26: A medical device described in any one of clauses 1 to 25, wherein one or more sensors are coupled to a substrate, the substrate being coupled to a distal section of the tube structure.

[0105]

[0128] Clause 27: A medical device described in any one of clauses 1 to 26, wherein one or more sensors and supporting electronics corresponding to the one or more sensors are disposed in a distal section of the tube structure.

[0106]

[0129] Clause 28: A medical device described in any one of clauses 1 to 27, wherein the tube structure is a hypotube.

[0130] Clause 29: A catheter system comprising: a catheter having a proximal end, a distal end, and a lumen extending through the proximal and distal ends, one or more sensors of one or more sensor types coupled to a distal section of the catheter, a first power and data coupling device configured to operatively associate with the catheter, and one or more power and / or data lines extending across or through a wall of the catheter between the first power and data coupling device and the one or more sensors, the power and data coupling device configured to capacitively couple to the one or more power and / or data lines thereby transmitting and receiving electrical signals.

[0107]

[0131] Clause 30: A catheter system comprising: a catheter having a proximal end, a distal end, and a lumen extending through the proximal and distal ends, the lumen configured to receive a guidewire; one or more sensors of one or more sensor types coupled to a distal section of the catheter; a proximal power and data coupling device configured to operatively associate with the proximal section of the catheter; and a distal power and data coupling device coupled to the distal section of the catheter, wherein the proximal power and data coupling device and the distal power and data coupling device are configured to conductively contact the guidewire when the guidewire is inserted through the lumen of the catheter, thereby enabling passage of electrical signals between the proximal section of the catheter and the distal section of the catheter via the guidewire. conclusion

[0132] Although particular embodiments of the present disclosure have been described in detail with reference to specific configurations, parameters, components, elements, etc., this description is illustrative and should not be construed as limiting the scope of the claimed invention.

[0108]

[0133] Furthermore, unless otherwise implied or expressly stated, it should be understood that for any given element of a component of a described embodiment, any of the possible alternatives listed for that element or component may generally be used individually or in combination with each other.

[0109]

[0134] Moreover, unless otherwise indicated, numbers expressing quantities, configurations, distances, or other measures used in the specification and claims are to be understood as being optionally modified by the term "about" or a synonym thereof. When terms such as "about," "approximately," "substantially," and the like are used in conjunction with a stated quantity, value, or condition, this can be construed to mean that the quantity, value, or condition deviates by less than 20%, less than 10%, less than 5%, or less than 1% from the stated quantity, value, or condition. At the very least, and without attempting to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0110]

[0135] All headings and sub-headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims.

[0111]

[0136] It should also be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" do not exclude plural referents unless the context clearly dictates otherwise. Thus, for example, an embodiment that references a singular referent (e.g., a "widget") can also include two or more such referents.

[0112]

[0137] It will also be understood that the embodiments described herein can include properties, features (e.g., components, components, members, elements, parts, and / or portions) described in other embodiments described herein. Accordingly, various features of a given embodiment can be combined with and / or incorporated into other embodiments of the present disclosure. Thus, the disclosure of a particular feature with respect to a particular embodiment of the present disclosure should not be construed as limiting the application or inclusion of said feature to the particular embodiment. Conversely, it will be understood that other embodiments can also include such features.

[0113]

[0138] The present invention may be embodied in other specific forms without departing from its spirit or characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the present invention is therefore defined by the appended claims rather than the above description. All changes that come within the meaning and range of equivalency of the claims are intended to be embraced within their scope.

Claims

1. an elongated tubular structure for insertion into a body, the tubular structure having a proximal end, a distal end, and a lumen extending through said proximal end and said distal end; one or more sensors of one or more sensor types coupled to a distal section of the tubular structure; a guidewire positionable within at least a portion of the lumen of the tubular structure and passable through the tubular structure, the guidewire comprising at least one additional sensor coupled to a distal section of the guidewire; a first proximal power and data coupling device configured to be operably coupled to a proximal section of the tubular structure and a proximal section of the guidewire, the first proximal power and data coupling device configured to conductively couple to at least the guidewire and to transmit electrical signals to both the one or more sensors of the tubular structure and the at least one additional sensor of the guidewire and to receive electrical signals from both the one or more sensors of the tubular structure and the at least one additional sensor of the guidewire; A medical device comprising:

2. The medical device of claim 1 , wherein the elongated tubular structure is an over-the-wire catheter.

3. The medical device of claim 1 , wherein the elongated tubular structure is a rapid exchange catheter.

4. The medical device of claim 1, further comprising power and / or data lines disposed within the lumen or extending across or through a wall of the tubular structure between the first proximal power and data coupling device and the one or more sensors of the tubular structure.

5. The medical device of claim 1 , further comprising a second distal power and data coupling device disposed in a distal section of the tubular structure.

6. 6. The medical device of claim 5, wherein the first proximal power and data coupling device and the second distal power and data coupling device are configured to conductively contact the guidewire when the guidewire is inserted through the lumen of the tubular structure, thereby enabling passage of the electrical signals between the first proximal power and data coupling device and the second distal power and data coupling device of the tubular structure via the guidewire.

7. 7. The medical device of claim 6, wherein the first proximal power and data coupling device, the second distal power and data coupling device, or both, are configured to conductively couple to the guidewire by direct contact with the guidewire.

8. The medical device of claim 6 , wherein the first proximal power and data coupling device, the second distal power and data coupling device, or both, are configured to conductively couple to the guidewire by capacitive coupling.

9. The medical device of claim 8 , wherein the one or more sensors of the tubing structure are electrically connected to the second distal power and data coupling device at the distal section of the tubing structure.

10. The medical device of claim 1 , wherein the tubular structure is a peripherally inserted central catheter, a central venous catheter, or an intravenous catheter.

11. The medical device of claim 1 , wherein the first proximal power and data coupling device is configured to conductively couple to the guidewire by direct contact with the guidewire.

12. The medical device of claim 1 , wherein the first proximal power and data coupling device is configured to conductively couple to the guidewire through capacitive coupling with the guidewire.

13. The medical device of claim 1 , wherein the one or more sensor types on the tubular structure and / or the at least one additional sensor on the guidewire include two or more different sensor types.

14. The medical device of claim 1 , wherein the one or more sensor types of the tube structure and / or the at least one additional sensor of the guidewire are configured to provide simultaneous measurement of one or more physiological parameters.

15. The medical device of claim 1 , wherein the one or more sensors of the tubular structure and / or the at least one additional sensor of the guidewire have an active sampling rate of 5 seconds or less.

16. The medical device of claim 1 , wherein the one or more sensors in the tube structure and / or the at least one additional sensor in the guidewire include one or more pressure sensors.

17. 17. The medical device of claim 16, wherein the one or more pressure sensors comprise resistive, capacitive, optical, acoustic, photoacoustic, or a combination thereof.

18. The medical device of claim 16 , wherein the medical device comprises a plurality of pressure sensors spaced longitudinally along the length of the distal section of the tubular structure.

19. The medical device of claim 1 , wherein the one or more sensors of the tube structure and / or the at least one additional sensor of the guidewire include one or more ultrasound sensors, cameras, charge-coupled devices, or other imaging sensors.

20. The medical device of claim 1 , wherein the electrical signal comprises a power signal delivered through the guidewire to the one or more sensors in the tubular structure to power the one or more sensors in the tubular structure.

21. The medical device of claim 1 , wherein the electrical signal comprises a data signal transmitted through the guidewire by the one or more sensors in the tubular structure as a result of operation of the one or more sensors in the tubular structure.

22. The medical device of claim 1 , wherein the one or more sensors of the tubular structure are at least partially embedded in a wall of the tubular structure.

23. The medical device of claim 1 , wherein the one or more sensors of the tubular structure are coupled to a substrate, the substrate being coupled to a distal section of the tubular structure.

24. The medical device of claim 1 , wherein the one or more sensors of the tubular structure and supporting electronics corresponding to the one or more sensors are disposed in a distal section of the tubular structure.

25. The medical device of claim 1 , wherein the tubular structure is a hypotube.

26. The medical device of claim 6 , wherein the guidewire is passable through the first proximal power and data coupling device.

27. 27. The medical device of claim 26, wherein the guidewire is passable through the second distal power and data coupling device.

28. the guidewire is passable through the second distal power and data coupling device; The medical device of claim 6.

29. an elongated tubular structure for insertion into a body, the tubular structure having a proximal end, a distal end, and a lumen extending through said proximal end and said distal end; one or more sensors of one or more sensor types coupled to a distal section of the tubular structure; a guidewire positionable within at least a portion of the lumen of the tubular structure and passable through the tubular structure; a first proximal power and data coupling device configured to be operatively coupled to a proximal section of the tubular structure; and a second distal power and data coupling device disposed in the distal section of the tubular structure; and Equipped with the first proximal power and data coupling device and the second distal power and data coupling device are configured to conductively couple to the guidewire when the guidewire is inserted through the lumen of the tubular structure to enable passage of electrical signals through the guidewire between the first proximal power and data coupling device and the second distal power and data coupling device; the guidewire is passable through the first proximal power and data coupling device and the second distal power and data coupling device. Medical devices.

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