Medical and Guidewire Devices

Abstract

The guidewire system includes an elongated wire configured to be inserted into a lumen space of the body, such as a vasculature of the body. The wire is electrically conductive and configured to conduct electrical signals. One or more sensors are coupled to a distal section of the wire and configured to transmit and receive electrical signals through the wire. The wire to which the one or more sensors are coupled is the only wire through which the one or more sensors transmit and receive electrical signals.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS 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 / 205,964, entitled "GUIDEWIRE 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 Ser. 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 Ser. 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 Ser. No. 17 / 205,854, entitled "CATHETER 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 include various 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, in or near the patient's heart or brain. Radiographic imaging is typically used to assist in navigating 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 (0.254 mm), 0.014 inches (0.3556 mm), 0.016 inches (0.4064 mm), 0.018 inches (0.4572 mm), 0.024 inches (0.6096 mm), and 0.035 inches (0.889 mm), although smaller or larger diameters may also be used.

[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 coronary arteries).

[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 function.

[0008] Another common problem in this field is properly localizing and positioning the distal tip 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 arise. For example, in catheter implementations, improper positioning can lead to fluid seepage, which can result in patient pain or injury, 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] Furthermore, conventional techniques for internal imaging and catheter localization 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] The use of such interventional devices is also difficult due to the need to manage several long lengths of wires and other components, including guidewires, power cables, data wires, etc. Care must be taken regarding what is allowed 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] Therefore, 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, the guidewire system includes an elongated wire configured to be inserted into a body lumen space, such as a vasculature. The wire is electrically conductive and configured to conduct electrical signals. One or more sensors are coupled to a distal section of the wire and configured to transmit and receive electrical signals via the wire. The wire to which the one or more sensors are coupled is the only wire through which the one or more sensors transmit and receive electrical signals.

[0013] The one or more sensors may include two or more different sensor types, such as a pressure sensor and an ultrasound sensor. When multiple sensors are utilized, the guidewire system is configured to provide simultaneous measurement of one or more physiological parameters. That is, multiple sensors (which may be of two or more types) positioned at multiple locations can simultaneously transmit sensor data over the wire.

[0014] The guidewire system can include a proximal device operably coupled to the wire at a proximal segment of the wire, the proximal device configured to communicate with one or more sensors positioned on a distal segment of the wire via electrical signals passed through the wire. For example, the proximal device can be configured to transmit power through the wire to the one or more sensors and receive data signals through the wire from the one or more sensors.

[0015] In some embodiments, the one or more sensors are coupled to a substrate, and the substrate is coupled to a distal section of the wire. For example, the substrate can be wrapped around the distal section of the core. In some embodiments, the substrate is helically wrapped around the distal section of the core. In some embodiments, the substrate includes an elongated tube having a cut pattern that allows for radial expansion of the tube and positioning of the tube over a desired section of the wire before the tube returns to its smaller diameter default shape.

[0016]

[0016] In one embodiment, a method of using a guidewire system includes positioning a first member within a body lumen space, the first member including an elongated wire, the wire having a proximal portion and a distal portion, the wire being configured to conduct an electrical signal; coupling an electrical signal to the wire; and transmitting and receiving electrical signals via the wire from one or more sensors of one or more sensor types coupled to the distal portion of the wire.

[0017] The method can also include positioning a second member (e.g., a catheter) over or adjacent to the wire, translating the second member relative to the wire so that the second member enters the body, translating the second member over one or more sensors of one or more sensor types, and receiving data signals from the one or more sensors indicative of a relative position of the second member within the body with respect to the one or more sensors. The one or more sensors can include, for example, a plurality of pressure sensors aligned at a plurality of different longitudinal positions along a distal portion of the wire.

[0018] 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.

[0019]

[0019] 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 subject matter 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 appended claims, or may be learned by the practice of the invention as set forth hereinafter.

[0020] Various objects, features, characteristics and advantages of the present invention will become apparent and will be more readily understood from the following description of embodiments taken in conjunction with the accompanying drawings and 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 explanation of the drawings]

[0021] [Figure 1]

[0021] FIG. 1 is a schematic diagram of a guidewire system configured to provide one or more of the features described herein. [Figure 2]

[0022] 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. [Figure 3A]

[0023] 2 is a more detailed diagram of the guidewire system of FIG. 1 showing components of the power and data coupling device and indicating that the coupling device can be communicatively coupled to an external device. [Figure 3B]

[0024] FIG. 10 is an enlarged view of the distal section of the guidewire to better illustrate an exemplary sensor placement on the guidewire. [Figure 3C]

[0025] FIG. 10 is an enlarged view of the distal section of the guidewire to show additional distal components and features of the device. [Figure 4A]

[0026] 1A-1C illustrate an exemplary use of a guidewire system to effectively guide the positioning and placement of a stent in a targeted stenosis. [Figure 4B] 1A-1C illustrate an exemplary use of a guidewire system to effectively guide the positioning and placement of a stent in a targeted stenosis. [Figure 4C] 1A-1C illustrate an exemplary use of a guidewire system to effectively guide the positioning and placement of a stent in a targeted stenosis. [Figure 4D] 1A-1C illustrate an exemplary use of a guidewire system to effectively guide the positioning and placement of a stent in a targeted stenosis. [Figure 5A]

[0027] 1A-1C illustrate exemplary sensor substrates and arrangements in which such substrates can be used to position sensors on guidewires. [Figure 5B] 1A-1C illustrate exemplary sensor substrates and arrangements in which such substrates can be used to position sensors on guidewires. [Figure 5C] 1A-1C illustrate exemplary sensor substrates and arrangements in which such substrates can be used to position sensors on guidewires. [Figure 5D] 1A-1C illustrate exemplary sensor substrates and arrangements in which such substrates can be used to position sensors on guidewires. [Figure 5E] 1A-1C illustrate exemplary sensor substrates and arrangements in which such substrates can be used to position sensors on guidewires. [Figure 6]

[0028] Figures 6A, 6B, 6C, and 6D illustrate a process for applying a sensor substrate to a distal section of a guidewire. [Figure 7]

[0029] FIG. 2 is a detailed view of an exemplary ultrasound array that may be utilized within a guidewire. [Figure 8]

[0030] FIG. 2 is a detailed diagram of an exemplary power and data coupling device. [Figure 9]

[0031] Figures 9A and 9B illustrate alternative wire embodiments that may be utilized within the guidewire systems described herein. [Figure 10]

[0032] 1 illustrates a system and method for providing localization of a guidewire system within a body. DETAILED DESCRIPTION OF THE INVENTION

[0022] Overview of the Intraluminal System

[0033] 1 shows a schematic diagram of a guidewire system 100 that may incorporate one or more of the features described herein. Guidewire system 100 includes an elongated wire 102 that is routeable through a proximal device 104. Guidewire system 100 may alternatively be referred to herein as a "guidewire device" or simply as a "device." Wire 102 may also be referred to herein as a type of elongated conductive member.

[0023]

[0034] As used herein, an elongated conductive member includes any conductive component having a length greater than a width. For example, an elongated conductive member includes a wire 102. For purposes of example and explanation, an elongated conductive member may be referred to as a wire 102, although it will be understood that wires 102 are a subset of possible elongated conductive members. For example, an elongated member may also include a catheter 202.

[0024]

[0035] The "wire" of guidewire system 100 refers to a solid wire element that forms the backbone of guidewire system 100. Thus, the term "wire," when used in the context of guidewire system 100, is intended to refer to a structure that has sufficient torqueability, pushability, and stiffness / flexibility to be navigable within the body (e.g., capable of being routed through and positioned within a luminal space, such as a vasculature). Such "wire" elements are sometimes referred to in the art as "cores," "corewires," etc. Thus, this type of "wire" is intended to be distinguished from smaller, less structured elements, such as traces or leads, that are capable of carrying electrical signals but lack sufficient structure to be effectively navigated and positioned within the body to reach a targeted anatomical structure. By way of example, a "wire" suitable for use as part of the guidewire system 100 may have an average outer diameter of at least about 0.0762 mm (0.003 inches), or about 0.127 mm (0.005 inches), or about 0.2032 mm (0.008 inches), or about 0.254 mm (0.010 inches).

[0025]

[0036] In another example, a "wire" suitable for use as part of the guidewire system 100 may have a yield strength greater than 10 ksi, or more preferably greater than 30 ksi, or more preferably greater than 50 ksi, or more preferably greater than 100 ksi, or more preferably greater than 150 ksi, or more preferably greater than 200 ksi, or more preferably greater than 250 ksi, e.g., about 300 ksi. Additionally or alternatively, a "wire" suitable for use as part of guidewire system 100 may have a shear modulus of elasticity greater than 6.7 msi, or more preferably greater than 8 msi, or more preferably greater than 10 msi, e.g., about 12 msi. Additionally or alternatively, a "wire" suitable for use as part of guidewire system 100 may have a shear modulus of elasticity greater than 16 msi, or more preferably greater than 20 msi, or more preferably greater than 25 msi, e.g., about 30 msi.

[0026]

[0037] 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 the femoral, radial, and jugular vein, although the guidewire system 100 may utilize other access routes as needed.

[0027]

[0038] 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 understood 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.

[0028]

[0039] 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 the "power and data coupling device 104" or simply the "coupling device 104."

[0029]

[0040] The wire 102 has a proximal end 106 and a distal end 108. The length of the wire 102 can vary depending on the needs of a particular application and the anatomical area being targeted. By way of example, the wire 102 can have an overall length from the proximal end 106 to the distal end 108 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 can be sized to have an outer diameter (e.g., after application of other outer members) of about 0.008 inches to about 0.040 inches, although larger or smaller sizes can be utilized as needed for a particular application. For example, certain embodiments may have an outer diameter size corresponding to a standard guidewire size, such as 0.010 inch (0.254 mm), 0.014 inch (0.3556 mm), 0.016 inch (0.4064 mm), 0.018 inch (0.4572 mm), 0.024 inch (0.6096 mm), 0.035 inch (0.889 mm), 0.038 inch (0.9652 mm), or other such sizes common to guidewire devices. Wire 102 may be formed from stainless steel or other metals or alloys having similar suitable properties. In some embodiments, wire 102 may be formed from or include a conductive material with suitable mechanical properties.

[0030]

[0041] 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.

[0031]

[0042] 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 external device 110 are described herein, it will be understood that this is not required and other embodiments can include other “non-mobile” devices, such as a desktop computer, monitor, projector, etc. In some embodiments, 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 transmitted data from a transmitter and further transmitting that data to a non-mobile computer system. This can be useful in situations where a physician prefers 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 when their hands are full (e.g., when handling guidewire system 100).

[0032]

[0043] 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, thereby enabling the physician to better understand the relevant environment and make appropriate decisions while treating the patient.

[0033]

[0044] Wireless systems may include, for example, a personal area network (PAN) (e.g., very high frequency radio wave communications, 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.

[0034]

[0045] 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.

[0035]

[0046] 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, wire 102, or some combination of devices within guidewire system 100. 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, the presence / levels of various gases or biological components, temperature, other physical parameters, etc.).

[0036]

[0047] As described in more detail below, one or more sensors may be coupled to wire 102, and the one or more sensors may be operable to transmit data signals through wire 102 to coupling device 104. Additionally or alternatively, coupling device 104 may be operable to transmit power or signals to the one or more sensors.

[0037]

[0048] 2 is a schematic of a catheter system 200 that may incorporate one or more of the features described herein. Catheter system 200 may be similar in many respects to guidewire system 100, and the discussion above relating to guidewire system 100 is also applicable here, except where differences are noted.

[0038]

[0049] The catheter system 200 includes a catheter 202 and a proximal device 204 (which may also be referred to herein as a "power and data coupling device 204" or simply as a "coupling device 204"). The coupling device 204 includes a control unit 212 (shown enlarged and in 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. The catheter 202 may be referred to herein as a type of elongated conductive member.

[0039]

[0050] 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 positioned at any suitable location on the catheter 202 but are typically positioned at a distal section of the catheter 202 that is expected to reach the targeted anatomical structure. The sensors 221 may be coupled to the catheter 202 by using, for example, bonding, molding, co-extrusion, welding, and / or adhesive techniques.

[0040]

[0051] Power and / or data wires 201 extend along the length of the catheter 202 to one or more sensors 221. As used herein, "power line" and / or "data line" refer to any conductive pathway (e.g., trace) within a medical device. While multiple power and / or data lines 201 can be utilized, preferred embodiments are configured to transmit both power and data over a single line and / or manage sensor data signals from multiple sensors over a single line. This reduces the number of wires that must be routed through 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.

[0041]

[0052] The proximal 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 for temporary insertion into the body, may be sized and configured for permanent implantation 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 body's vascular system. 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-type catheter, or an IVUS catheter, or other imaging catheter. The catheter 202 may be a single- or multi-lumen catheter.

[0042]

[0053] Figure 3A provides another view of the guidewire system 100 of Figure 1. Guidewire system 100 shares certain features with catheter system 200, and therefore the description of the common portions is equally applicable to guidewire system 100. 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, as described above, enables wireless communication to an external device 110 (or multiple such devices).

[0043]

[0054] 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. 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" can be considered to be approximately the central third of the device, and the "proximal section" or "proximal portion" can be considered to be approximately the proximal third of the device.

[0044]

[0055] Unlike catheter system 200, guidewire system 100 is configured to transmit these power and data signals through the actual wire 102 itself. In some embodiments, multiple power and / or data signals (e.g., data signals from multiple sensors 121) can be transmitted simultaneously through wire 102. Power and / or data signals can also be transmitted "continuously." That is, the power and / or data signals can have a sufficiently high sampling rate so that information is provided to the user within a time frame that is practically "real time." In most applications, this includes sampling rates of about 5 seconds or less, 3 seconds or less, 1 second or less (e.g., during activity), or even sub-second sampling rates.

[0045]

[0056] 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 wires along the wire 102 to connect the sensor 121 to the proximal end and / or to deliver power to the sensor. Given that guidewires inherently come with strict dimensional and performance limitations (e.g., torqueability, flex, pushability, stiffness, etc.) 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 wires also reduces the overall complexity of the device, thereby reducing the risk of component failure and resulting in a more robustly functioning device. Additional Sensor Details

[0057] The one or more sensors 121 of the guidewire system 100 and / or the one or more sensors 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 collect various forms of imaging data.

[0046]

[0058] 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 detect, 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 can be configured to sense the presence, absence, or levels of biological constituents such as hormones (e.g., hormones, 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., alpha-fetoprotein, beta-human chorionic gonadotropin, carcinoembryonic antigen, prostate-specific antigen, calcitonin), and / or toxins (e.g., lead, ethanol). Guidewire Sensor Placement and Distal Features

[0059] FIG. 3B shows an expanded view of the distal section of the guidewire system 100, illustrating various sensors disposed therein. In this embodiment, the sensors include multiple pressure sensors 120 and an ultrasound sensor 122. These sensors are positioned on a substrate 124, which is positioned on the wire 102 to place the sensors at their desired locations. The substrate 124 can be made of a somewhat flexible material (e.g., a suitable medical-grade polymer) that allows it to be wrapped around the wire 102, wrapped around the wire 102, or otherwise positioned on the wire 102. The substrate 124 also includes flexible circuitry, such as trace lines and / or one or more conductive contacts, for conductively coupling the sensors to the underlying wire 102. The substrate 124 can form a friction fit with the wire 102 or, additionally or alternatively, can be mechanically bonded to the wire 102.

[0047]

[0060] Bonding sensors to the substrate 124 and then disposing the substrate 124 on the wire 102 provides several benefits. For example, the substrate 124 can be essentially laid out in a two-dimensional layout, making it much easier to properly position the sensors. The two-dimensional substrate 124 with the sensors bonded to it can then be disposed on the three-dimensional cylindrical wire 102 more easily than if each sensor were disposed individually on the wire 102. In particular, ensuring that the various sensors are properly positioned relative to each other on the substrate 124 and then disposing the substrate 124 on the wire 102 is easier than trying to control the relative spacing of each sensor on the three-dimensional cylindrical wire 102. However, it will be appreciated that in at least one embodiment, the benefits of the two-dimensional substrate 124 are not obtained, but the various sensors can be disposed directly on the three-dimensional wire 102. Alternatively, the various sensors can be disposed on the substrate after it is applied to the three-dimensional wire 102.

[0048]

[0061] The illustrated embodiment also includes an outer member 126 (shown here in hidden lines) that can be positioned over the sensor-containing portion of the wire 102. The outer member 126 can be formed from a suitable medical-grade polymer (e.g., polyethylene terephthalate (PET) or polyether block amide (PEBAX)). The outer member 126 can function to further constrain and maintain the position of the sensor and / or to provide a smooth outer surface for a more uniform outer diameter. The outer member 126 can be applied by interference fitting a tube in place, dip coating, and / or other manufacturing methods known in the art. A hydrophilic coating can also be added to the outer surface of the device.

[0049]

[0062] FIG. 3C shows another schematic diagram of the distal section of the guidewire system 100, depicting multiple pressure sensors 120 and multiple ultrasound sensors 122 disposed on a substrate 124 positioned on the wire 102. As shown, the distal-most section of the device may also include a coil 128 and / or an atraumatic tip 130. The coil 128 may be a single coil or multiple connected or interwoven coils. Additionally or alternatively, a polymer material may be positioned or applied to the distal section of the wire 102. The atraumatic tip 130 may optionally form a sphere or other curved shape to protect against trauma caused by the distal end of the wire 102. The atraumatic tip 130 may be formed, for example, from a polymer adhesive material and / or solder.

[0050]

[0063] As shown, the wire 102 can include a ground profile that results in a smaller diameter in the more distal section of the wire 102. For typical guidewire sizes (e.g., 0.014 inch, 0.018 inch, 0.024 inch), the wire 102 can be approximately 0.002 inch in diameter at the distal end. The distal end of the wire 102 can also be flattened to form a standard "ribbon" shape.

[0051]

[0064] The illustrated embodiment also includes an energy harvester 132. The energy harvester is configured to convert the injected power into a regulated DC voltage suitable for the sensors. The energy harvester 132 can also provide other electrical conditioning functions, such as cutting power to the sensors during faults or power savings. Additionally, unless otherwise specified, the energy harvester 132 is considered to be a subcomponent of the one or more sensors 121. Thus, unless otherwise stated, references to the one or more sensors 121 also refer to associated circuitry, such as the energy harvester 132.

[0052]

[0065] Additionally, in at least one embodiment, the energy harvester is configured to provide control functions for one or more sensors 121. For example, a specific signal can be communicated from the power and data coupling device 104 to the energy harvester. The specific signal can include a chirp, an impulse function, or some signal on a specific frequency channel. The energy harvester maps the specific signal to a predetermined command and then acts on the predetermined command. For example, a specific signal can be mapped to a command to cut DC power to one or more rails powering one or more sensors. Thus, upon receiving the specific signal, the energy harvester stops providing power to one or more sensors, thereby turning off the one or more sensors. 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 receives, interprets, and / or acts on the signal.

[0053]

[0066] Unless otherwise noted, references to sensors (either generically or to specific types of sensors) should be understood to include support electronics as well. Support electronics may include, for example, power conditioners, transducers, signal amplifiers, processing components such as application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), and the like. Support electronics for one or more sensors 121 are preferably positioned near the one or more sensors 121 themselves (e.g., in a distal section on the substrate 124). This has been found to beneficially reduce signal drift compared to placing the support electronics in a proximal section of the device. Locating the support electronics (e.g., ASICs) in a distal section near the sensor 121 and using the wire 102 itself as a means to transmit data signals to the proximal end provides effective signal transmission without the drift issues that are otherwise noticeable.

[0054]

[0067] The length of the wire 102, including the substrate 124 (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 vary as needed for a particular application. As described below with respect to the examples of FIGS. 4A through 4D , in a preferred embodiment, the length of the sensor arrangement substantially spans the expected length of the lesion / stenosis or other target anatomical structure. A linear arrangement of pressure sensors 120 can be used to provide pressure mapping of the targeted anatomical structure without the need to move the wire 102. Multiple measurements from multiple sensors can be taken simultaneously and / or sequentially. The arrangement of pressure sensors 120 can also be used to measure pulse wave velocity (PWV) (e.g., by determining a series of wave peaks and measuring the time between peaks) and / or provide spatial tracking of the pulse waveform. Methods for localization within target anatomical structures

[0068] 4A-4D show a sequence illustrating the use of guidewire system 100 to effectively guide the positioning and placement of a medical device at a targeted anatomical location. In this particular example, guidewire system 100 is used to properly position stent 406 at a targeted stenosis 404.

[0055]

[0069] 4A shows a wire 102 with a pressure sensor 120 positioned within a blood vessel 402 (other components have been removed for better visibility). The wire 102 is routed through the blood vessel 402 to a location where the placement of the pressure sensor 120 spans or at least substantially coincides with a stenosis 404. Because the stenosis 404 creates a pressure differential in that portion of the blood vessel 402, the linear placement of the pressure sensor 120 allows the user to effectively position the wire 102 to coincide with the stenosis 404, and a user can advance the wire 102 until those pressure differences are read by the sensor 120. For example, if the blood vessel 402 is a coronary artery, the pressure distal to the stenosis 404 will be slightly lower than the pressure proximal to the stenosis 404. The wire 102 can be advanced until one or more of the most distal pressure sensors reaches an area of ​​different pressure (e.g., the slightly lower pressure within a coronary stenosis).

[0056]

[0070] A stent 406 is then delivered over the wire 102 towards the stenosis 404. The position of the stent 406 relative to the wire 102 can be determined based on readings from the pressure sensor 120. For example, as the stent 406 is moved distally, it begins to sequentially pass the pressure sensor 120, causing a change in the pressure reading of the sensor, thereby allowing a user to determine the position of the stent 406 relative to the wire 102.

[0057]

[0071] 4B shows stent 406 positioned further within blood vessel 402 toward its target location. A delivery catheter 408 is also shown. In stent delivery applications such as those shown here, delivery catheter 408 can be a balloon catheter, or stent 406 can be a self-expanding stent. Other stent types and stent delivery means known in the art can also be utilized. Proper positioning of stent 406 is possible because the position of wire 102 relative to stenosis 404 is known; therefore, determining where stent 406 is positioned relative to wire 102 allows for the position of stent 406 relative to stenosis 404 to be determined.

[0058]

[0072] After it is determined that the stent 406 is in the proper position relative to the target stenosis 404, the stent 406 can be deployed, as shown in Figure 4C. After deployment, the wire 102 can remain in place for a period of time during post-stent evaluation. The wire 102 can then be retracted from the vessel 402, leaving the stent 406 in place, as shown in Figure 4D.

[0059]

[0073] Guidewire system 100 can thus provide a localized frame of reference (i.e., a frame of reference within the target localized anatomy) to guide the positioning of a medical device. This is beneficial because the target anatomy is not always stationary. For example, in vasculature applications, the blood vessels are constantly moving due to the heartbeat. The localized frame of reference defined by the distal section of guidewire system 100 substantially moves with the target anatomy in which it is located, eliminating many of the positioning complexities and thereby improving the ability to position stents and / or other medical devices.

[0060]

[0074] This localized frame of reference is also relatively stable because it does not require movement of wire 102 to take sequential measurements. That is, the linear arrangement of sensors 120 allows for multiple measurements without having to "back out" wire 102 to take measurements at other locations. Furthermore, as noted above, the system may be configured to provide multiple measurements from multiple sensors simultaneously, thereby even eliminating the need for "virtual backing out" of sequential measurements along the length of the sensor.

[0061]

[0075] 4A-4D is one example of the use of guidewire system 100 for localization within a target anatomical structure. Guidewire system 100 and / or catheter system 200 can also be utilized in other applications where the localization features of the system would be beneficial. For example, the localization features described herein can be utilized to assist in the proper placement of a PICC catheter or central venous catheter at a targeted site, such as the caval-atrial junction. Sensor substrate and guidewire applications

[0076] 5A-5E show additional exemplary configurations of the substrate 124. FIG. 5A provides an example of a substrate 124 having a structure that allows for helical wrapping of the wire 102, similar to that shown in FIGS. 3B and 3C. FIG. 5B shows an example of a substrate 124 having a cut or split within its structure. The substrate 124 of FIG. 5B can also be positioned around the wire 102 until the edges meet or overlap at the cut / split. Alternatively, the substrate 124 of FIG. 5B can form a "clamshell" structure in which two halves are placed over the wire 102 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 configured to engage with each other when joined together.

[0062]

[0077] Figure 5C shows an example of a substrate 124 having a tubular structure with a cut pattern 538 that allows the tube to be manipulated for placement over the wire 102. Figure 5C shows a spiral 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 for placement over the wire 102. However, the cut pattern 538 is preferably distributed circumferentially around the tube to avoid the formation of preferred bending planes within the tube.

[0063]

[0078] 5D and 5E provide one example of how substrate 124 can be manipulated during placement onto wire 102. FIG. 5D shows the tubular structure of substrate 124 in its default state. By appropriately twisting the ends 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 wire 102 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 wire 102. In some embodiments, the tube can tighten sufficiently to form a friction fit around wire 102. As discussed above, adhesive bonding and / or placement of an outer member can additionally or alternatively serve to hold substrate 124 in place.

[0064]

[0079] 6A-6D show a series of steps for applying a sensor substrate 124 to a wire 102. In this example, the substrate 124 is in the form of a strip configured to be wrapped helically around the wire 102 (similar to the embodiment shown in FIG. 5A). FIG. 6A shows the substrate 124 disposed in a flat position. The substrate 124 includes a base material 636 (e.g., a suitable medical-grade polymer) and a pair of 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.

[0065]

[0080] 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 in desired locations, and the conductive polymer can then be applied and cured (if necessary) to form the conductive traces 634.

[0066]

[0081] The conductive traces 634 provide conductive contact for a sensor (e.g., a pressure sensor 120 as shown, although other sensor types described herein may additionally or alternatively be used) so that the sensor 120 can be positioned in conductive communication with the underlying wire 102 after the substrate 124 is applied to the wire 102. For example, the conductive traces 634 may extend from an outer surface to an inner surface (at least in one location) of the substrate 124 to form conductive contact with the underlying wire 102. Alternatively or additionally, one or more dedicated wire contacts (e.g., at one or both ends of the substrate 124) may be utilized to form conductive contact with the underlying wire 102.

[0067]

[0082] The conductive trace 634 may be formed as one or more continuous and uninterrupted lines as shown, or alternatively, one or more individual sections of conductive material may be included within the substrate 124, so long as each of the individual sections is positioned in conductive communication with the underlying wire 102 for corresponding placement of the sensor.

[0068]

[0083] As shown in FIG. 6B, the sensor 120 is positioned so that it is offset from the longitudinal axis of the planar substrate 124. This allows the sensor to be aligned with the longitudinal axis of the wire 102 when the substrate 124 is helically wrapped around the wire 102, as shown in FIG. 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 wire 102 is important. The offset angle can be, for example, about 10-35 degrees from the longitudinal axis, although other offset angles can be utilized depending on factors such as the wrap angle of the substrate 124 when applied to the wire 102 and the desired final orientation of the sensor 120.

[0069]

[0084] The spacing of the sensors 120 on the substrate 124 and / or the wrap angle when applying the substrate 124 to the wire 102 can also be modified to adjust the resulting position and spacing of the sensors 120 relative to the underlying wire 102. For example, the illustrated embodiment shows each successive sensor 120 circumferentially offset by approximately 120 degrees from the adjacent sensor. Other circumferential offset angles can also be utilized according to design preference and / or the needs of a particular application. Preferred embodiments include some form of circumferential offset to better space the sensors 120 around the circumference of the device and thus better eliminate circumferential position as a variable in the overall sensor reading.

[0070]

[0085] 6D shows the application of outer member 126 onto substrate 124. As mentioned above, outer member 126 can be applied using shrink tubing, dip coating, and / or other means known in the art for applying polymer coatings to guidewires. For illustrative purposes, sensor 120 is shown slightly above the outer surface of outer member 126. In most embodiments, sensor 120 is flush with the outer surface of outer member 126. Imaging function

[0086] The guidewire system 100 can include one or more sensors for providing imaging. Figure 7 shows an example of an ultrasonic sensor 122. Like the other sensors described herein, the ultrasonic sensor 122 can be disposed on a substrate 124, which is then positioned over the wire 102. The illustrated ultrasonic sensor 122 includes one or more (preferably multiple) micromachined capacitive ultrasonic transducers (CMUTs) 742 and corresponding supporting electronics in the form of complementary metal-oxide semiconductor (CMOS) chips 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 over the wire 102, and none of the CMOS chips 740 need to multiplex multiple signals from separate CMUTs 742.

[0071]

[0087] The ultrasound sensor 122 of the guidewire system 100 can be configured to operate at any suitable set of frequencies. In some embodiments, the ultrasound sensor 122 can operate at a center frequency of about 5 to about 25 MHz, about 8 to about 20 MHz, about 10 to about 15 MHz, or any other range using any two of the above values ​​as endpoints. In contrast, typical IVUS applications utilize center frequencies of 20 to 40 MHz, or even above 50 MHz. These conventional IVUS applications provide high relative resolution but are limited to an imaging depth of about 5 to 10 mm.

[0072]

[0088] The use of these lower frequencies in the guidewire system 100 described herein provides better imaging depth without undue sacrifice of resolution. Because the guidewire is smaller than a typical IVUS catheter, the ultrasound sensor 122 can be farther from the targeted anatomical structure (e.g., a vessel wall), and therefore the additional imaging depth is beneficial. The resolution associated with such frequencies has been found to be sufficient to locate a target (e.g., a stenosis) and / or properly size a medical device (e.g., a stent) for placement.

[0073]

[0089] Some embodiments of guidewire system 100 may additionally or alternatively include other imaging sensors. For example, guidewire system 100 may include a camera device configured to capture various types of imaging data, including pixel array, image, video, or other types of imaging data. Guidewire system 100 may include any imaging device known in the art suitable for positioning at or integration with the distal portion of the system, including a fiber optic camera, a LIDAR system, a Raman scattering system, a mm-wave camera, an infrared imaging system, 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

[0090] 8 provides a detailed view of an exemplary power and data coupling device 104. Although coupling device 104 is shown here as a hemostatic valve, the components and associated functionality of coupling device 104 described herein can be provided by other structures that do not necessarily provide valve functionality. However, because hemostatic valves are common in guidewire applications, integrating components of coupling device 104 into a hemostatic valve is a beneficial implementation.

[0074]

[0091] The illustrated coupling device 104 includes a body 844 that houses a power source in the form of a battery 846 (corresponding to power source 114 of FIG. 3A ) and a transmitter 118. Coupling device 104 may additionally or alternatively include a wired power connection 847, although in preferred embodiments the use of additional wiring is minimized. Coupling device 104 also includes a first conductive surface 850 (shown in this example in the form of a conductive tube) positioned for wire 102 to pass through when inserted and translated through coupling device 104.

[0075]

[0092] The illustrated coupling device 104 is configured to function as a capacitive coupler, allowing for connection and disconnection of power and / or data transmission to the wire 102 without requiring direct contact with the wire 102. In particular, the first conductive surface 850 functions as a first conductive surface configured to couple to a second conductive surface (i.e., the wire 102). In operation, the first conductive surface 850 includes (or is connected to) a pickup configured to emit a time-varying electric field to convey power to the wire 102 and receive a data signal from the wire 102. Because the space between the outer surface of the wire 102 and the inner surface of the first conductive surface 850 is typically filled with blood, which has a relatively high electrical conductivity, capacitive coupling can be established without requiring a particularly high voltage (e.g., 5 to 12 volts is typically sufficient). The first conductive surface 850 is communicatively connected to a transmitter 118 so that data signals can be transmitted from the coupling device 104 to one or more external devices 110 (see FIGS. 1 and 3A).

[0076]

[0093] Beneficially, the coupling device 104 allows the wire 102 to remain communicatively coupled to one or more external devices 110 throughout the procedure. For example, a catheter can be advanced over the wire 102 and through the coupling device without disrupting the electrical coupling between the first conductive surface 850 and the wire 102. While the catheter passes between the outer surface of the wire 102 and the inner surface of the first conductive surface 850, capacitive contact is maintained at a level that allows for the continued transmission of power and data signals. Thus, the illustrated coupling device 104 allows a user to pass a catheter (or other outer member) over the wire 102 while maintaining constant communication with sensors at the distal section of the wire 102 without requiring an additional disconnection / reconnection step. 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 wire. In addition to the complications associated with connecting and disconnecting wires, this means that there are moments when visualization and / or other data signals from the wire are stopped.

[0077]

[0094] Although the embodiment shown includes first 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 wire 102. Coupling device 104 may include one or more additional supporting electronic components, such as an amplifier for amplifying the signal.

[0078]

[0095] The coupling device 104 can be configured to provide power to the wire 102 while simultaneously receiving a data signal from the wire 102. In some implementations, the coupling device 104 can provide multiple different power signals to the wire 102 (e.g., each power signal configured to power a different sensor or set of sensors) and / or receive multiple different data signals from the wire 102 (e.g., each data signal from a different sensor or set of sensors).

[0079]

[0096] In at least one embodiment, power and data coupling device 104 includes indicators to show information regarding the operation of power and data coupling device 104 or guidewire system 100. The indicators may include an audio alert, a visual alert (e.g., a light), a communication to an external device (e.g., external device 110) that performs an alert function, and / or any other type of alert. For example, transmitter 118 may include some processing capability that can detect an interruption in the power traveling through power and data coupling device 104 and / or a poor quality of the data signal received by power and data coupling device 104. In such cases, an alert indication may be issued by power and data coupling device 104 to notify a user of the problem. Additional Wire Variations

[0097] 9A shows an example where the wire 102 includes multiple segments 952, such as when an extension is connected to the wire 102. In various use cases, it may be necessary to lengthen the wire 102 to better position and / or manipulate the wire 102 within a patient's body. The segments 952 shown can be coupled together to form the entire wire 102 via any number of different physical connections, including, but not limited to, threaded connections, magnetic connections, press-fit connections, snap connections, adhesive connections, or combinations thereof.

[0080]

[0098] In at least one embodiment, the resulting physical connection provides a continuous conductive path from one segment 952 to the next. Thus, multiple segments 952 assembled together, at least by physical and electrical connection, can be considered collectively and referred to as a "wire 102." More specifically, an electrical signal applied to a first segment 952 can propagate to other segments 952 of the wire 102. Accordingly, unless otherwise noted, all descriptions of a wire 102 provided herein include embodiments in which the wire 102 includes one or more extension wires.

[0081]

[0099] 9B shows another example in which the wire 102 includes multiple strands 954 arranged to form a single, unitary structure. The number of strands 954 can be varied as needed for a particular application. As shown, the strands 954 are twisted, interwoven, or otherwise arranged together to form an overall structure that functions as the wire 102. Typically, the individual strands 954 are in conductive contact with each other, so that a power or data signal going to one strand 954 propagates through all of the strands 954, and the strands 954 function together as a single wire 102. Guidewire tip localization

[0100] The guidewire system 100 can be utilized with one or more detection nodes 1056, 1058 to assist in determining the location of the wire 102 within the body. Figure 10 illustrates an example of routing the wire 102 to a targeted coronary artery of a patient (e.g., as part of a coronary angioplasty procedure). While this example illustrates a procedure involving a coronary artery as a target using femoral access, the detection nodes 1056, 1058 can be used in other procedures involving other target anatomies and / or other access sites as well.

[0082]

[0101] In the example shown, the wire 102 is inserted into the body and routed so that the distal end 108 enters the aortic arch and advances downward toward the target coronary artery. Detection nodes 1056, 1058 are positioned at one or more predetermined locations on the patient to assist the physician in identifying the location of the distal end 108 of the wire 102. As the wire 102 is advanced through the vasculature and into the vicinity of the detection node 1056 or 1058, the detection node 1056 or 1058 detects the proximity of the wire 102 via any well-known detection and sensing mechanism known in the art.

[0083]

[0102] For example, nodes 1056, 1058 may be configured to provide ultrasound transmissions and detect ultrasound reflections. When coil 128 of guidewire system 100 passes within range of node 1056 or 1058, node 1056 or 1058 may be configured to detect coil 128 (which typically comprises a material with high radiopacity, such as a platinum-iridium alloy) and respond by providing an audio signal, a visual indicator, and / or by sending a signal via a wired or wireless connection to one or more external devices 110 (see FIGS. 1 and 3A).

[0084]

[0103] Additionally or alternatively, detection nodes 1056, 1058 may be configured to detect ultrasound signals transmitted by guidewire system 100. As discussed above, guidewire system 100 may be configured to transmit ultrasound at a lower frequency than standard IVUS applications. Thus, the lower frequency travels further into the surrounding tissue and can be detected by nodes 1056, 1058. Additionally or alternatively, other detection methods (e.g., detecting a magnet on wire 102, using radio frequency signals) may be utilized, although it is preferable to use a method that does not require the addition of additional components to wire 102.

[0085]

[0104] Nodes 1056, 1058 can be placed at predetermined locations to assist in guiding wire 102 to the appropriate target location. In the example shown, node 1056 is placed at a location corresponding to an area of ​​the vasculature through which wire 102 is not intended to pass, and node 1058 is positioned along the intended path to the target coronary artery. Node 1056 can thus be configured as a warning node 1056 that can alert the physician that wire 102 has entered an unintended area of ​​the vasculature. In the procedure shown, warning nodes 1056 can be placed near the carotid artery and the subclavian artery, for example. In contrast, node 1058 can be configured as a confirmation node 1058 that indicates that the wire is passing through the intended path.

[0086]

[0105] The number of alert nodes 1056 and / or confirmation nodes 1058 can vary according to particular preferences or application needs, and therefore, embodiments utilizing such nodes may include one or more of either or both types of nodes. Additional Computer System Details

[0106] Certain methods described herein can be implemented by a computer system including one or more processors and a computer-readable medium, such as 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.

[0087]

[0107] The functionality of a computing system can be enhanced by its ability 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 via serial, parallel, USB, or other connections. These connections enable a computing system to access the services of the other computing systems and receive application data from the other computing systems quickly and efficiently.

[0088]

[0108] The interconnection of computing systems has facilitated distributed computing systems, such as so-called “cloud” computing systems. In this description, “cloud computing” can refer to systems or resources that enable 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 published with reduced administrative effort or service provider interaction. Cloud models can be composed of a variety of characteristics (e.g., on-demand self-service, wide network access, resource pooling, 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.).

[0089]

[0109] Cloud and remote-based service applications are also becoming popular. Such applications are hosted on public and private remote systems, such as the cloud, and typically provide a set of web-based services to interact with clients.

[0090]

[0110] Many computers are intended to be used by direct user interaction with the computer. Accordingly, 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. Additionally, a variety of software user interfaces are available.

[0091]

[0111] 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.

[0092]

[0112] The disclosed embodiments may comprise or utilize special-purpose or general-purpose computers, 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.

[0093]

[0113] Physical computer-readable storage media include RAM, ROM, EEPROM, CD-ROM or other optical disk storage (CDs, DVDs, 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.

[0094]

[0114] 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 over a network or another communications connection (hardwired, wireless, or a combination of hardwired or wireless) to a computer, 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.

[0095]

[0115] Furthermore, upon reaching various computer system components, program code means in the form of computer-executable instructions or data structures may be automatically transferred from transmission computer-readable media to physical computer-readable storage media (or vice versa). For example, computer-executable instructions or data structures received over a network or data link may be buffered in RAM within a network interface module (e.g., a "NIC") and then ultimately transferred to the computer system's RAM and / or to the computer system's low-volatility computer-readable physical storage media. Thus, computer-readable physical storage media may be included within computer system components that also utilize (or even primarily utilize) transmission media.

[0096]

[0116] 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. While the subject matter has been described in language specific to structural features and / or methodological acts, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the described features or acts. Rather, the described features and acts are disclosed as example forms of implementing the claims.

[0097]

[0117] Those skilled in the art will appreciate that the present invention can be practiced in networked computing environments 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 can also be practiced in distributed system environments where 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 can be located in both local and remote memory storage devices.

[0098]

[0118] Alternatively or additionally, the functionality 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

[0119] Embodiments of the present disclosure may include, but are not necessarily limited to, the features set forth in the following clauses.

[0099]

[0120] Clause 1: A medical device comprising: an elongated wire configured to be inserted into the body, the wire having a proximal end and a distal end, the wire configured to carry an electrical signal; and one or more sensors of one or more sensor types coupled to a distal section of the wire, the one or more sensors configured to transmit and receive electrical signals via the wire.

[0100]

[0121] Clause 2: A medical device as described in clause 1, wherein the wire to which the one or more sensors are coupled is the only wire through which the one or more sensors send and receive electrical signals.

[0101]

[0122] Clause 3: The medical device of clause 1 or 2, further comprising one or more outer members disposed over at least a portion of the wire.

[0123] Clause 4: A medical device described in any one of clauses 1 to 3, wherein the one or more sensor types include two or more different sensor types.

[0102]

[0124] Clause 5: A medical device described in any one of clauses 1 to 4, wherein the multiple sensors are configured to provide simultaneous measurement of one or more physiological parameters.

[0125] Clause 6: A medical device described in any one of clauses 1 to 5, wherein the active sampling rate of one or more sensors is 5 seconds or less.

[0103]

[0126] Clause 7: A medical device described in any one of clauses 1 to 6, wherein the one or more sensors include one or more pressure sensors.

[0127] Clause 8: The medical device of clause 7, wherein the one or more pressure sensors include a resistive, capacitive, optical, acoustic, photoacoustic sensor, or a combination thereof.

[0104]

[0128] Clause 9: The medical device of clause 7 or 8, wherein the plurality of pressure sensors are longitudinally spaced along the length of the distal section of the wire.

[0129] Clause 10: A medical device as described in Clause 9, wherein the multiple pressure sensors are arranged on the wire such that a circumferential offset is applied between each successive pressure sensor or each successive set of two or more pressure sensors.

[0105]

[0130] Clause 11: A medical device described in any one of clauses 1 to 10, wherein the one or more sensors include one or more ultrasonic sensors.

[0131] Clause 12: A medical device described in any one of clauses 1 to 11, wherein the electrical signal includes a power signal delivered through a wire to the one or more sensors to power the one or more sensors.

[0106]

[0132] Clause 13: A medical device described in any one of clauses 1 to 12, wherein the electrical signal comprises a data signal transmitted by one or more sensors through a wire as a result of operation of the one or more sensors.

[0107]

[0133] Clause 14: A medical device described in any one of clauses 1 to 13, further comprising a proximal device attached to a proximal section of the wire, the proximal device configured to communicate with one or more sensors positioned in a distal section of the wire via electrical signals passed through the wire.

[0108]

[0134] Clause 15: A medical device as described in Clause 14, wherein the proximal device is configured to transmit power to the one or more sensors through the wire and receive data signals from the one or more sensors through the wire.

[0109]

[0135] Clause 16: The medical device of any one of clauses 1-15, wherein the wire comprises a stranded member having two or more strands bonded together to form the wire.

[0136] Clause 17: A medical device described in any one of clauses 1 to 16, wherein the wire comprises a plurality of extensions removably attached to one another.

[0110]

[0137] Clause 18: A medical device described in any one of clauses 1 to 17, wherein the wire has an average outer diameter of at least about 0.0762 mm (0.003 inches), or at least about 0.127 mm (0.005 inches), or at least about 0.2032 mm (0.008 inches), or at least about 0.254 mm (0.010 inches).

[0111]

[0138] Clause 19: A medical device described in any one of clauses 1 to 18, wherein one or more sensors are coupled to a substrate, and the substrate is coupled to a distal section of the wire.

[0139] Clause 20: The medical device of clause 19, wherein the substrate is helically wrapped around the distal section of the wire.

[0112]

[0140] Clause 21: The medical device of clause 19, wherein the substrate is an elongated tube.

[0141] Clause 22: The medical device of clause 21, wherein the tube includes a cut pattern that allows radial expansion of the tube.

[0113]

[0142] Clause 23: The medical device of any one of clauses 1 to 22, wherein the wire comprises a conductive polymer.

[0143] Clause 24: A medical device described in any one of clauses 1 to 23, wherein the wire is configured to be routed through the vasculature of the body.

[0114]

[0144] Clause 25: A medical device described in any one of clauses 1 to 24, wherein one or more sensors and supporting electronics corresponding to the one or more sensors are disposed on a distal section of the wire.

[0115]

[0145] Clause 26: A guidewire device for use within a body intraluminal space, comprising: an elongate wire having a proximal end and a distal end and configured to conduct electrical signals; one or more sensors of one or more sensor types coupled to a distal section of the wire; and a proximal device associated with a proximal section of the wire, wherein the proximal device is configured to transmit power through the wire to the one or more sensors, and the proximal device is configured to receive data signals from the one or more sensors of the one or more sensor types through the wire.

[0116]

[0146] Clause 27: A method of using a medical device, the method comprising: positioning a first member within a body lumen space, the first member including an elongated wire; coupling an electrical signal to the wire, the wire having a proximal portion and a distal portion, the wire being configured to conduct the electrical signal; and transmitting and receiving electrical signals via the wire from one or more sensors of one or more sensor types coupled to a distal portion of the wire.

[0117]

[0147] Clause 28: The method of clause 27, further comprising: positioning a second member on or adjacent to the wire; translating the second member relative to the wire such that the second member is moved into the body; translating the second member over one or more sensors; and receiving data signals from the one or more sensors indicative of the relative position of the second member within the body to the one or more sensors.

[0118]

[0148] Clause 29: The method of clause 28, wherein the sensors are positioned at multiple longitudinal positions along the distal portion of the wire.

[0149] Clause 30: A method according to any one of clauses 27 to 29, wherein by positioning the wire within the body, one or more sensors establish a localised frame of reference, thereby enabling localisation of the second member within the localised frame of reference. conclusion

[0150] While particular embodiments of the present disclosure have been described in detail with reference to particular configurations, parameters, components, elements, etc., these descriptions are illustrative and should not be construed as limiting the scope of the claimed invention.

[0119]

[0151] Furthermore, unless otherwise implied or expressly stated, it should be understood that for any given element of the components of the described embodiments, any of the possible alternatives listed for that element or component may generally be used individually or in combination with each other.

[0120]

[0152] Moreover, unless otherwise indicated, numbers expressing quantities, configurations, distances, or other measures used in the specification and claims are to be understood as optionally modified by the term "about" or its synonyms. When terms such as "about," "approximately," or "substantially" are used in connection with a stated quantity, value, or condition, this can be interpreted to mean that the quantity, value, or condition deviates from the stated quantity, value, or condition by less than 20%, less than 10%, less than 5%, or less than 1%. 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.

[0121]

[0153] 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.

[0122]

[0154] 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, embodiments that refer to a singular referent (e.g., a "widget") can also include two or more such referents.

[0123]

[0155] It will also be understood that the embodiments described herein may include properties, characteristics (e.g., components, components, members, elements, parts, and / or portions) described in other embodiments described herein. Accordingly, various features of a given embodiment may 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 may also include such features.

[0124]

[0156] 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 foregoing 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 wire configured to be inserted into a body lumen space, the elongated wire having a proximal end and a distal end, the elongated wire configured to conduct an electrical signal; one or more sensor types coupled to a distal section of the elongate wire; a plurality of sensors configured to transmit and receive the electrical signals via the elongated wires; Equipped with the elongated wire is the only wire through which the plurality of sensors transmit and receive the electrical signals; the plurality of sensors are coupled to a substrate, the substrate being coupled to the distal section of the elongate wire; the electrical signals include power signals delivered to the plurality of sensors through the elongated wires to power the plurality of sensors, and data signals transmitted by the plurality of sensors through the elongated wires as a result of operation of the plurality of sensors. Medical devices.

2. The medical device of claim 1 , further comprising one or more outer members disposed over at least a portion of the elongate wire.

3. an elongated wire configured to be inserted into a body lumen space, the elongated wire having a proximal end and a distal end, the elongated wire configured to conduct an electrical signal; two or more different sensor types coupled to a distal section of the elongate wire; a plurality of sensors configured to transmit and receive the electrical signals via the elongated wires; Equipped with the elongated wire is the only wire through which the plurality of sensors transmit and receive the electrical signals; the plurality of sensors are coupled to a substrate, the substrate being coupled to the distal section of the elongate wire; the electrical signals include power signals delivered to the plurality of sensors through the elongated wires to power the plurality of sensors, and data signals transmitted by the plurality of sensors through the elongated wires as a result of operation of the plurality of sensors. Medical devices.

4. The medical device of claim 1 , wherein the multiple sensors are configured to provide simultaneous measurements of one or more physiological parameters.

5. 10. The medical device of claim 1, wherein the activity sampling rate of the plurality of sensors is 5 seconds or less. medical devices.

6. The medical device of claim 1 , wherein the plurality of sensors includes one or more pressure sensors.

7. The medical device of claim 6 , wherein the one or more pressure sensors comprise a resistive, capacitive, optical, acoustic, photoacoustic sensor, or a combination thereof.

8. The medical device of claim 6 , wherein a plurality of pressure sensors are longitudinally spaced along the length of the distal section of the wire.

9. 9. The medical device of claim 8, wherein the plurality of pressure sensors are arranged on the elongate wire such that each successive pressure sensor or each successive set of two or more pressure sensors has a circumferential offset.

10. The medical device of claim 1 , wherein the plurality of sensors includes one or more ultrasonic sensors.

11. 10. The medical device of claim 1, further comprising a proximal device associated with a proximal section of the elongate wire, the proximal device configured to communicate with the plurality of sensors positioned on the distal section of the elongate wire via the electrical signals passed through the elongate wire.

12. The medical device of claim 11 , wherein the proximal device is configured to transmit power to the plurality of sensors through the elongate wire and receive data signals from the plurality of sensors through the elongate wire.

13. The medical device of claim 1 , wherein the elongated wire comprises a stranded member having two or more strands bonded together to form the elongated wire.

14. The medical device of claim 1 , wherein the elongated wire comprises a plurality of extensions removably attached to one another.

15. 10. The medical device of claim 1, wherein the elongated wire has an average outer diameter of at least 0.127 mm (0.005 inches).

16. The medical device of claim 1, wherein the substrate is spirally wrapped around the distal section of the elongated wire.

17. The medical device of claim 16 , wherein the substrate is an elongated tube.

18. the tube includes a cut pattern that allows for radial expansion of the tube. Item 18. The medical device described in item 17.

19. The medical device of claim 1 , wherein the elongated wire comprises a conductive polymer.

20. The medical device of claim 1 , wherein the elongated wire is configured to be routed through a body vasculature.

21. The medical device of claim 1 , wherein the plurality of sensors and supporting electronics coupled to the plurality of sensors are disposed on a distal section of the elongated wire.

22. The medical device of claim 1 , wherein the elongated wire is a core wire.

23. 1. A guidewire device for use within an intraluminal space of a body, comprising: a core wire having a proximal end and a distal end and configured to carry an electrical signal; a plurality of sensors of one or more sensor types coupled to a distal section of the core wire; a proximal device associated with the proximal section of the core wire; the proximal device is configured to transmit power through the core wire to the plurality of sensors; the proximal device is configured to receive data signals from the plurality of sensors of one or more sensor types through the core wire; the plurality of sensors are coupled to a substrate, the substrate being coupled to the distal section of the core wire; Guidewire device.

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