Medical Guidewire Assembly and / or Electrical Connector

Abstract

A flexible medical guidewire assembly is provided that is configured to be inserted into a confined space defined by a living body. [Solution] The sensor assembly is securely supported by a flexible medical guidewire assembly such that once the flexible medical guidewire assembly is inserted into and moved along an enclosed space defined by a living body, the sensor assembly and the flexible medical guidewire assembly are movable along the enclosed space defined by the living body. Also disclosed is an electrical connector assembly having a connector terminal. The connector terminal is configured to be electrically connectable with a terminal portion of the flexible medical guidewire assembly. The terminal portion is electrically connected to the sensor assembly of the flexible medical guidewire assembly via an electrical wire.

Description

[Technical Field]

[0001] This document relates to (but is not limited to) the technical field of medical devices, (more particularly) this document relates to (but is not limited to) the technical field of medical guidewire assemblies (and / or methods therefore), and (even more particularly) this document relates to (but is not limited to) the technical field of electrical connectors for medical guidewire assemblies (and / or methods therefore). [Background technology]

[0002] Known medical devices are configured to facilitate medical procedures and to assist medical personnel in diagnosing and / or treating medical conditions in ill patients. Summary of the Invention

[0003] It will be appreciated that a need exists to alleviate (at least in part) at least one problem associated with existing (known) medical devices (also referred to as existing technology). After much research and experimentation with existing (known) medical devices, an understanding of the problem and its solution (at least in part) has been identified (at least in part) and articulated (at least in part) as follows:

[0004] Cardiac catheterization is a medical procedure involving the insertion of a catheter into a patient's cardiac chambers or blood vessels. This may be performed for diagnostic and / or interventional purposes. A common example of cardiac catheterization is coronary catheterization, which involves catheterization of the coronary arteries for the treatment of coronary artery disease and myocardial infarction (heart attack). Catheterization may be performed in a specialized laboratory equipped with fluoroscopy and a highly maneuverable table (the specialized laboratory may be equipped with various sized catheters, stents, balloons, and other cabinets to improve the operational efficiency of the specialized laboratory). Monitors may show (display) fluoroscopic imaging, electrocardiogram (ECG or EKG) data, pressure wave images, and more.

[0005] Transseptal catheterization is a medical procedure used by interventional cardiologists to gain access to the left atrium of a patient's heart. This medical technique was first introduced for left-sided pressure measurement and has been integrated into a variety of procedures, including left atrial ablation and percutaneous mitral valvuloplasty, among others.

[0006] Cardiac ablation is a medical procedure to scar or destroy tissue within the heart where incorrect electrical signals cause abnormal heart rhythms. A diagnostic catheter is threaded to the heart where blood vessels are used to map the heart's electrical signals.

[0007] Transseptal puncture (TSP) is a medical procedure used during childhood and adulthood to gain access for catheter ablation, hemodynamic evaluation of the left heart, left ventricular assist device implantation, percutaneous left atrial appendage closure, or mitral valvuloplasty.

[0008] Transseptal catheterization procedures may require several device exchanges between known transseptal needles (and any equivalents thereof), also referred to as scarring devices, and known guidewires. Known transseptal needles may be utilized to access the left heart transseptally for medical diagnostic and / or interventional procedures, among others.

[0009] A catheter is a flexible medical tube configured to be inserted into a body cavity (of a patient) through a narrow opening, such as the bladder (or other) for fluid removal. First, a known guidewire is attached to the patient, and then the catheter is pushed along and guided by the known guidewire (once the catheter is positioned, the guidewire can be removed from the patient's body). All device exchanges and repositioning of the catheter involve uncertain and / or potentially dangerous exposure to x-ray radiation to the patient and / or physician (it may be desirable to keep x-ray radiation exposure to a minimum).

[0010] A problem with transseptal puncture devices is that they may not be compatible with non-fluoroscopic imaging modalities, and specifically may not be optimized to maximize the utility of electroanatomical (EAM) mapping and / or other electrophysiology (EP) retrieval systems (and any equivalents thereof).

[0011] Fluoroscopy is an X-ray procedure that allows for the viewing of moving internal organs. Fluoroscopy uses X-rays (which are radioactive) to generate real-time video images. To reduce and / or eliminate the need for fluoroscopy, it may be valuable to visualize the tip of a medical device (such as a tissue-piercing device, electrode, etc.) on a map (volume map or view of the patient's interior) generated by an electroanatomic mapping (EAM) system, which may also be performed while augmenting any imaging provided by an ultrasound system (using tools such as intracardiac echocardiography (ICE)).

[0012] It will be appreciated that obtaining information regarding the spatial location of a medical device (such as a tissue puncture device, transseptal needle, etc.) attached to the distal portion of the guidewire may be valuable, and some physicians may occasionally require the use of fluoroscopy to ensure that the starter guidewire has been safely tracked from the inferior vena cava (IVC) leading into the heart to the superior vena cava (SVC) of the patient's heart. Additionally, after removing the transseptal needle, it may be necessary to confirm the path of the guidewire on the left side of the heart (due to the uncertainty associated with the distal position of the guidewire).

[0013] It may be beneficial to provide a guidewire configured to function as a tissue piercing device while being optimized for use in a non-fluoroscopic imaging mode for exchange steps associated with a medical procedure (e.g., for exchange of a medical device over a known guidewire, etc.).

[0014] The following are some identified problems: known diagnostic catheters (e.g., including needles or puncture devices within known catheters) (A) may feature hubs that may not be usable for catheter exchange (medical device exchange), (B) may not be rigid enough to be utilized in procedures for performing transseptal punctures, e.g., for cardiac cases, etc., and / or (C) are utilized for low voltage applications (whereas potential solutions may, in some cases, use relatively high voltage delivery devices, e.g., to function as electrosurgical devices, etc.).

[0015] It would be beneficial to provide a flexible medical guidewire configured for use in minimally invasive medical procedures. A physician may need to deploy an additional diagnostic catheter (over the medical guidewire) to perform a desired medical task, such as an electrophysiology study (EPS), as part of a medical therapy. It will be appreciated that the wire may be used to deliver the diagnostic catheter, and sometimes the wire may be used to deliver a sheath that can ultimately guide the diagnostic catheter.

[0016] It may be beneficial to provide a medical guidewire configured to sense signals (electrical, magnetic, etc.) that are input into a signal recording system for subsequent signal analysis. The signals (preferably relatively high accuracy signals) may be correlated with an electrocardiogram (ECG) in any configuration, such as unipolar or bipolar, etc.

[0017] It may be beneficial to provide a medical guidewire having at least one or more sensor devices (such as multiple electrodes, etc.) supported by the medical guidewire. The sensor devices may improve spatial resolution, simplify workflow, and / or provide material savings. For example, after a cardiac catheterization procedure is completed with a catheterization device attached to the tip of the medical guidewire, the medical guidewire may then be repositioned (or temporarily placed) in another region of the heart to facilitate signal recording (provided as a sensor output signal from a sensor attached to the medical guidewire) during treatment. Particular regions of the heart that may require signal recording (such as during an electrophysiology study) may include the right atrium (RA), right ventricle (RV), and / or coronary sinus (CS), among others. It may also be beneficial to provide a medical guidewire configured to emit (transmit or transmit) signals in a predetermined manner, such as a bipolar and / or monopolar manner (preferably, the medical guidewire is additionally configured to receive signals). Diagnostic electrophysiology (EP) catheters (also called EP diagnostic catheters) can be used for temporary intracardiac sensing, recording, stimulation, and mapping. EP diagnostic catheters may be indicated for both recording and pacing (or as needed) cardiac tissue. Additionally, known electroanatomical mapping (EAM) systems may require the emission of a sensing signal from an emitter device (signal source), which may be sensed by another device (signal receiving device), such as a receiver pad placed on the patient, etc.

[0018] It may be beneficial to utilize at least one embodiment in research and development projects and / or medical clinical environments. It would be beneficial to provide a medical guidewire that adds at least one medical function that can be performed by multiple separate medical devices.

[0019] To at least partially alleviate at least one problem associated with existing technology, an apparatus is provided (according to a principal aspect). The apparatus includes, but is not limited to, (comprises) a synergistic combination of a flexible medical guidewire assembly and a sensor assembly. The flexible medical guidewire assembly is configured to be inserted into a confined space defined by a living body. The sensor assembly is securely supported by the flexible medical guidewire assembly. This is done so that once the flexible medical guidewire assembly is inserted into and moved along the confined space defined by the living body, the sensor assembly and the flexible medical guidewire assembly are movable along the confined space defined by the living body. It will be understood that the detailed description provides a description of an embodiment of the flexible medical guidewire assembly.

[0020] To at least partially alleviate at least one problem associated with existing technology, a method is provided (according to a principal aspect). The method includes, but is not limited to, the following steps (operations): (A) providing a flexible medical guidewire assembly configured to be inserted into an enclosed space defined by a living body; and (B) providing a sensor assembly securely supported by the flexible medical guidewire assembly such that, once the flexible medical guidewire assembly is inserted into and moved along the enclosed space defined by the living body, the sensor assembly and the flexible medical guidewire assembly are movable along the enclosed space defined by the living body. It will be understood that the detailed description provides a description of embodiments of the flexible medical guidewire assembly. Preferably, the method for utilizing a flexible medical guidewire assembly includes: (A) providing a flexible medical guidewire assembly configured to be inserted into an enclosed space defined by a living body, wherein there is a sensor assembly securely supported by the flexible medical guidewire assembly; (B) inserting the sensor assembly and the flexible medical guidewire assembly at least partially into the enclosed space defined by the living body; and (C) moving the sensor assembly and the flexible medical guidewire assembly at least partially along the enclosed space defined by the living body once the flexible medical guidewire assembly is inserted into the enclosed space defined by the living body.

[0021] To at least partially alleviate at least one problem associated with existing technology, an apparatus is provided (according to a principal aspect). The apparatus includes, but is not limited to, an electrical connector assembly having a connector terminal. The connector terminal is configured to be electrically connectable with a terminal portion (wire terminal) of a flexible medical guidewire assembly. The flexible medical guidewire assembly is configured to be inserted into a closed space defined by a living body. The terminal portion is electrically connected to a sensor assembly of the flexible medical guidewire assembly via an electrical wire. It will be understood that the detailed description provides a description of an embodiment of the electrical connector assembly.

[0022] To at least partially alleviate at least one problem associated with existing technology, a method is provided (according to a principal aspect). The method includes, but is not limited to, providing an electrical connector assembly having a connector terminal. The connector terminal is configured to be electrically connectable with a terminal portion of a flexible medical guidewire assembly. The flexible medical guidewire assembly is configured to be inserted into an enclosed space defined by a living body. The terminal portion is electrically connected to a sensor assembly of the flexible medical guidewire assembly via an electrical wire. It will be understood that the detailed description provides a description of an embodiment of the electrical connector assembly. Preferably, the method utilizes an electrical connector assembly, the method comprising: (A) providing an electrical connector assembly having a connector terminal configured to be electrically connectable with a terminal portion of a flexible medical guidewire assembly, the flexible medical guidewire assembly being configured to be inserted into a closed space defined by a living body, the terminal portion being electrically connected to a sensor assembly of the flexible medical guidewire assembly via an electrical wire; and (B) electrically connecting the connector terminal of the electrical connector assembly to the terminal portion of the flexible medical guidewire assembly.

[0023] To at least partially alleviate at least one problem associated with existing technology, a method is provided (according to a principal aspect), the method including, but not limited to, the following steps (actions): action (A), action (B), action (C), and action (D). Action (A) includes utilizing a medical imaging system (such as an intracardiac echocardiography (ICE) system, an electroanatomical mapping (EAM) system, or the like, and any equivalent thereof) to generate (register, display, or the like) medical images (such as voltage maps, a shape capture system configured to capture tissue shapes, or the like, and any equivalent thereof) of a patient's relevant anatomical structure (such as the right atrium of the heart, the septum separating the right and left atria of the heart, or the like). Operation (B) includes inserting (deploying, advancing, moving, etc.) the flexible medical guidewire assembly toward the patient's relevant anatomical structure (i.e., inserting the flexible medical guidewire assembly toward the patient's relevant anatomical structure along a closed space defined by the living body) once (or after) medical images have been generated by the medical imaging system and displayed to the physician performing the procedure. Operation (C) includes utilizing the medical imaging system to detect the spatial position of a sensor assembly (fixedly attached to a portion of the flexible medical guidewire assembly) (while the flexible medical guidewire assembly is being inserted into the patient toward the patient's relevant anatomical structure) so that the spatial position of a portion (such as the tip) of the flexible medical guidewire assembly can be identified (detected) by the medical imaging system (i.e., the position of the portion of the flexible medical guidewire assembly can be displayed to the physician while the flexible medical guidewire assembly is being inserted into the patient toward the patient's relevant anatomical structure).Operation (D) includes (once the physician has determined that the portion of the flexible medical guidewire assembly has reached or is positioned adjacent to the patient's relevant anatomical structure, and the flexible medical guidewire assembly is held spatially immobile relative to the patient's relevant anatomical structure) guiding insertion of a medical instrument (along the length of the flexible medical guidewire assembly) toward the patient's relevant anatomical structure (i.e., now that the flexible medical guidewire assembly has reached a position where it is positioned adjacent to the patient's relevant anatomical structure, the medical instrument is moved along the enclosed space defined by the living body toward the patient's relevant anatomical structure), and in this manner the medical instrument can be activated (or utilized) for medical treatment of the patient's relevant anatomical structure. It will be understood that other operations may include reversing the operational steps described above, such as to deactivate and / or withdraw the medical instrument from the patient and withdraw the flexible medical guidewire assembly from the patient. It will be understood that if the flexible medical guidewire assembly includes a heating device, and that additional operations may include activating the heating device (once the physician determines (based on generated medical images provided by a medical imaging system) that the portion of the flexible medical guidewire assembly has reached or is positioned adjacent to the patient's relevant anatomical structure, and the flexible medical guidewire assembly is held spatially immobile relative to the patient's relevant anatomical structure). It will be understood that further operational steps may be added in view of the detailed description.

[0024] To at least partially alleviate at least one problem associated with existing technology, a method is provided (according to a principal aspect), the method including, but not limited to, the following steps (actions): action (A), action (B), action (C), and action (D). Action (A) includes utilizing a medical imaging system (such as an intracardiac echocardiography (ICE) system, an electroanatomical mapping (EAM) system, or the like, and any equivalent thereof) to generate (register, display, or the like) medical images (such as a volume map, a shape capture system configured to capture tissue shapes, or the like, and any equivalent thereof) of a patient's relevant anatomical structure (such as the right atrium of the heart, the septum separating the right and left atria of the heart, or the like). Operation (B) includes inserting (deploying, advancing, moving, etc.) the flexible medical guidewire assembly toward the patient's relevant anatomical structure (i.e., inserting the flexible medical guidewire assembly toward the patient's relevant anatomical structure along a restricted space defined by the living body) once (or after) medical images have been generated by the medical imaging system and displayed to the physician performing the procedure, etc. Operation (C) includes utilizing the medical imaging system to detect the spatial position of a sensor assembly (fixedly attached to a portion of the flexible medical guidewire assembly) (while the flexible medical guidewire assembly is being inserted into the patient toward the patient's relevant anatomical structure) so that the spatial position of a portion (such as the tip) of the flexible medical guidewire assembly can be identified (detected) by the medical imaging system (i.e., the position of the portion of the flexible medical guidewire assembly can be displayed to the physician while the flexible medical guidewire assembly is being inserted into the patient toward the patient's relevant anatomical structure). Operation (D) includes activating a heating device (disposed and fixedly positioned adjacent to a portion of the flexible medical guidewire assembly) once the physician determines that the portion of the flexible medical guidewire assembly has reached or is positioned adjacent to the relevant anatomical structure of the patient and the flexible medical guidewire assembly is held spatially immovable relative to the relevant anatomical structure of the patient.It will be understood that the medical instrument for this method may or may not be deployed in conjunction with deployment of the heating device, in that deployment of the medical instrument is optional for the method. It will be understood that other actions may include reversing the operational steps described above, such as to deactivate and / or withdraw the medical instrument from the patient (if a medical instrument is utilized) and / or withdraw the flexible medical guidewire assembly from the patient. It will be understood that further operational steps may be added in view of the detailed description.

[0025] Other aspects are identified in the claims. Other aspects and features of the non-limiting embodiments may now become apparent to those skilled in the art upon review of the following detailed description of the non-limiting embodiments in conjunction with the accompanying drawings. This Summary is provided to introduce concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify potentially key features or possible essential features of the disclosed subject matter, nor is it intended to describe each disclosed embodiment or every implementation of the disclosed subject matter. Many other novel advantages, features, and relationships will become apparent as this description proceeds. The figures and the following description more particularly exemplify exemplary embodiments.

[0026] Non-limiting embodiments may be more fully understood by reference to the following detailed description of non-limiting embodiments when taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0027] [Figure 1A] 1A and 1B show side perspective views of an embodiment of a flexible medical guidewire assembly. [Figure 1B] 1A and 1B show side perspective views of an embodiment of a flexible medical guidewire assembly. [Figure 1C] 1A and 1B show side perspective views of an embodiment of a flexible medical guidewire assembly. [Figure 1D] 1A and 1B show side perspective views of an embodiment of a flexible medical guidewire assembly. [Figure 2A] 1A, 1B, 1C, and / or 1D show front views of embodiments of the flexible medical guidewire assembly. [Figure 2B] 1A, 1B, 1C, and / or 1D show front views of embodiments of the flexible medical guidewire assembly. [Figure 3] 1E shows a front perspective view of an embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 4] 1E shows a front perspective view of an embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 5] 1E shows a front perspective view of an embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 6A] 6A and 6B show axial (FIG. 6A) and radial (FIG. 6B) cross-sectional views of an embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 6B] 6A and 6B show axial (FIG. 6A) and radial (FIG. 6B) cross-sectional views of an embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 7A] 1E shows a radial cross-sectional view of the embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 7B] 1E shows a radial cross-sectional view of the embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 7C] 1E shows a radial cross-sectional view of the embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 7D] 1E shows a radial cross-sectional view of the embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 7E] 1E shows a radial cross-sectional view of the embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 8A] 1E shows a radial cross-sectional view of the embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 8B] 1E shows a radial cross-sectional view of the embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 9A]1E shows a side view of the embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 9B] 9B shows a side view of an embodiment of an electrical connector configured to be connectable to the flexible medical guidewire assembly of FIG. 9A. [Figure 9C] 9B shows a side view of an embodiment of an electrical connector configured to be connectable to the flexible medical guidewire assembly of FIG. 9A. [Figure 9D] 9B shows a side view of an embodiment of an electrical connector configured to be connectable to the flexible medical guidewire assembly of FIG. 9A. [Figure 9E] 9B shows a side view of an embodiment of an electrical connector configured to be connectable to the flexible medical guidewire assembly of FIG. 9A. [Figure 9F] 9B shows a side view of an embodiment of an electrical connector configured to be connectable to the flexible medical guidewire assembly of FIG. 9A. [Figure 10A] 1E shows a side view of an embodiment of an electrical connector configured to be connectable to the flexible medical guidewire assembly of FIG. 1D. [Figure 10B] 1E shows a side view of an embodiment of an electrical connector configured to be connectable to the flexible medical guidewire assembly of FIG. 1D. [Figure 11A] 1E shows a perspective view of an embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 11B] 1E shows a perspective view of an embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 11C] 11C shows a side view of an embodiment of an electrical connector configured to be connectable to the flexible medical guidewire assembly of FIG. 11A and / or FIG. 11B. [Figure 12A] 1E shows a perspective view of an embodiment of the flexible medical guidewire assembly of FIG. 1D. [Figure 12B] 12B shows a side view of an embodiment of an electrical connector configured to be connectable to the flexible medical guidewire assembly of FIG. 12A. [Figure 12C]12B shows a side view of an embodiment of an electrical connector configured to be connectable to the flexible medical guidewire assembly of FIG. 12A. DETAILED DESCRIPTION OF THE INVENTION

[0028] The drawings are not necessarily to scale and may be shown in phantom, schematic, and partial views. In certain instances, details unnecessary for understanding the embodiments (and / or details that make other details difficult to perceive) may be omitted. Corresponding reference characters indicate corresponding components throughout the several views of the drawings. Elements in the various figures are shown for simplicity and clarity and are not drawn to scale. The dimensions of some of the elements in the figures may be exaggerated relative to other elements to facilitate understanding of the various disclosed embodiments. Additionally, common, well-understood elements useful in commercially viable embodiments are often not shown to provide an obscured view of the disclosed embodiments.

[0029] DETAILED DESCRIPTION OF NON-LIMITING EMBODIMENTS The following detailed description is merely exemplary and is not intended to limit the described embodiments or the application and uses of the described embodiments. As used, the words "exemplary" or "exemplary" mean "serving as an example, instance, or illustration." Any implementation described as "exemplary" or "exemplary" should not necessarily be construed as preferred or advantageous over other implementations. All implementations described below are example implementations provided to enable one skilled in the art to make or use embodiments of the present disclosure and are not intended to limit the scope of the disclosure. The scope of the claims is defined by the appended claims (as the claims may be amended during patent prosecution after the filing of this application). For purposes of description, the terms "upper," "lower," "left," "rear," "right," "front," "vertical," "horizontal," and their derivatives shall refer to the examples oriented in the drawings. No binding is intended by any expressed or implied theory in the preceding technical field, background, abstract, or the following detailed description. It should also be understood that the devices and processes illustrated in the accompanying drawings, and described in the following specification, are example embodiments, aspects, and / or concepts defined in the appended claims. Therefore, dimensions and other physical characteristics relating to the disclosed embodiments should not be considered limiting unless the claims expressly state otherwise. The phrase "at least one" is understood to be equivalent to "one (a)." Aspects (examples, modifications, variations, options, variations, embodiments, and any equivalents thereof) are described with reference to the drawings. It is understood that the present invention is limited to the subject matter provided by the claims, and not to the specific aspects shown and described. It is understood that the scope of meaning of a device configured to be coupled to an article (i.e., connected to an article, interacting with an article, etc.) is to be interpreted as the device being configured to be coupled to the article either directly or indirectly. Thus, "configured to" can include the meaning of "either directly or indirectly," unless otherwise specified.

[0030] 1A, 1B, 1C, and 1D show side perspective views of an embodiment of a flexible medical guidewire assembly 102. FIG. Referring to the embodiment shown in FIG. 1A , a device is shown that includes, but is not limited to, a synergistic combination of a flexible medical guidewire assembly 102 and a sensor assembly 104. The flexible medical guidewire assembly 102 is configured to be inserted into a confined space defined by a living body 902. An embodiment of the living body 902 is shown in FIG. 2A or 2B . The living body 902 may include a human body, among others. The sensor assembly 104 is securely supported by (configured to be supported by) the flexible medical guidewire assembly 102. This is done so that once the flexible medical guidewire assembly 102 is inserted into and moved along the confined space defined by the living body 902, the sensor assembly 104 and the flexible medical guidewire assembly 102 are movable along the confined space defined by the living body 902. The flexible medical guidewire assembly 102 may include any type of flexible material. The sensor assembly 104 may include any type of sensor assembly.

[0031] 1A , the flexible medical guidewire assembly 102 includes a sensor assembly 104 (preferably) configured to respond to a stimulus (such as heat, light, sound, pressure, magnetism, or specific motion thereof, and any equivalents thereof) and transmit a resulting signal (such as an impulse for measuring the signal or for operating a control function, etc.). Preferably, the flexible medical guidewire assembly 102 is configured to include (support) the sensor assembly 104. The sensor assembly 104 may include a radiation emitter, an energy emitter, an energy receiver, a magnetic flux emitter, a rare earth magnet, etc., and any equivalents thereof. According to an embodiment, the flexible medical guidewire assembly 102 and the sensor assembly 104 are configured to be selectively attachable to and detachable from each other.

[0032] Referring to the embodiment as shown in FIG. 1A , the flexible medical guidewire assembly 102 is (preferably) configured to guide the insertion of a medical device 900 (such as a catheter, etc., and any equivalent thereof) into the confined space defined by the living body 902 (as shown in FIG. 2A or 2B ) once the flexible medical guidewire assembly 102 is inserted into the confined space defined by the living body 902. The flexible medical guidewire assembly 102 is (preferably) configured to facilitate catheter exchange (exchange of a medical device or removal and insertion of a medical device). The flexible medical guidewire assembly 102 (preferably) includes a relatively thin, flexible wire (an elongated, flexible shaft) configured to be inserted into a confined or tortuous space (such as the confined space defined by the living body 902). The flexible medical guidewire assembly 102 (preferably) provides a guide for the subsequent insertion of the medical device 900. The medical instrument 900 may include a relatively stiff and / or bulky medical device (medical instrument), such as a catheter (medical catheter), etc. The medical device has a relatively stiff stiffness compared to the stiffness of the flexible medical guidewire assembly 102. A catheter provides (includes) a flexible tube (made from a medical material) configured to be inserted through a narrow opening into a body cavity space (a closed space defined by the living body 902), such as the bladder, to remove fluid therefrom. A catheter may be configured to be inserted into the body to treat a disease or perform a surgical procedure. By varying the material or adjusting the way the catheter is manufactured, it is possible to tailor catheters for cardiovascular, urinary, gastrointestinal, neurovascular, and ophthalmic applications. Catheters may also be configured to allow drainage, administration of fluids or gases, access by surgical instruments, and performance of a wide variety of other tasks. The process of inserting a catheter is a catheterization procedure. A catheter may include a thin, flexible tube (soft catheter), and catheters may be available in various levels of stiffness depending on the medical task or application.It will be appreciated that when the catheter is too soft, the catheter can be inserted into the body cavity by first inserting the flexible medical guidewire assembly 102 into the (same) body cavity, and then having the flexible medical guidewire assembly 102 guide the catheter as it is pushed into the body cavity.

[0033] 1A , the flexible medical guidewire assembly 102 is configured for insertion into a confined space defined by a living body 902, in a manner (preferably) assisted only by a user (doctor or technician) or by any medical device previously inserted and positioned in the confined space defined by the living body 902, etc. The flexible medical guidewire assembly 102 is (preferably) impermeable to bodily fluids disposed in the confined space defined by the living body 902 (once the flexible medical guidewire assembly 102 is inserted into the confined space defined by the living body 902). According to a preferred embodiment, the flexible medical guidewire assembly 102 has an outer diameter (preferably) of about 2 millimeters (mm) and an elongated length of about 30 inches to about 90 inches, although it will be understood that other dimensions for the flexible medical guidewire assembly 102 are possible. According to an embodiment, flexible medical guidewire assembly 102 has an elongate length of (preferably) about 150 centimeters (cm) to about 260 cm, and an outer diameter of about 0.025 inches to about 0.035 inches.

[0034] 1B, flexible medical guidewire assembly 102 includes a synergistic combination of (preferably) core element 106 and jacket element 108 (also referred to as a jacket portion, envelope, outer coating, etc.) that surrounds core element 106 (also referred to as a mandrel). Core element 106 and jacket element 108 extend along the elongate length of flexible medical guidewire assembly 102. Flexible medical guidewire assembly 102 (preferably) has a circular cross-sectional section or profile (it will be understood that other profile shapes may be utilized).

[0035] 1B, the core element 106 includes a (preferably) rigid inner mandrel. The core element 106 (preferably) provides additional rigidity to the flexible medical guidewire assembly 102.

[0036] Referring to the embodiment shown in FIG. 1B, the core element 106 preferably comprises SAE (Society of Automotive Engineering) standard 304 stainless steel. SAE standard 304 stainless steel contains both chromium (15%-20%) and nickel (2%-10.5%) as its primary non-ferrous components. The core element 106 also comprises superelastic nitinol (alternatively). Nitinol alloys exhibit two closely related unique properties: the shape memory effect (SME) and superelasticity (SE; also known as pseudoelasticity or PE). Shape memory is the ability of nitinol to deform at a certain temperature and then recover its original, undeformed shape upon heating above its transformation temperature. Superelasticity occurs in a narrow temperature range just above its transformation temperature, where no heating is required to recover the undeformed shape, and the material exhibits exceptional elasticity, approximately 10-30 times greater than that of ordinary metals.

[0037] 1B, the core element 106 (preferably) provides a combination of electrical and mechanical properties. It will be appreciated that the core element 106 may not need to be electrically connected or act as a power line (electrical wire).

[0038] With reference to the embodiment as shown in FIG. 1B, the core element 106 has a degree of stiffness that is (preferably) constant along the length of the flexible medical guidewire assembly 102 (providing constant stiffness), or the degree of stiffness can vary along the length of the flexible medical guidewire assembly 102 (variable stiffness).

[0039] 1B, the core element 106 may include a hollow tube, such as a hypotube stiffener. A hypotube is a long metal tube with micro-machined features along the length of the tube. According to an optional embodiment, the hollow tube is configured to receive and house electrical wires 405. The hollow tube may provide a modular configuration, and the hollow tube may provide cutouts to control (adjust) the flexibility (stiffness) of the hollow tube, etc.

[0040] 1C , flexible medical guidewire assembly 102 (preferably) includes sensor assembly 104. Sensor assembly 104 (preferably) includes magnetic sensor device 402. Magnetic sensor device 402 may include a rare earth magnet, a permanent magnet, and / or an electromagnet. Magnetic sensor device 402 includes a material configured to exhibit at least one property of magnetism, such as attracting other ferrous objects, aligning itself in an external magnetic field, etc.

[0041] Referring to the embodiment shown in FIG. 1C , the sensor assembly 104 includes an electrical sensor device 404 (biosensor, etc.) configured to transmit a signal (preferably), which may be transmitted via an electrical wire 405 and / or via a wireless transmitter device (known and not shown). The electrical sensor device 404 is configured to transmit (emit) an electrical signal (biological signal) and / or receive an electrical signal (biological signal). The electrical sensor device 404 is configured to detect events and / or changes in its environment and transmit (transmit) the information to other electronic devices (such as a computer processor, etc.). A biosensor is an analytical device configured to detect chemicals and may combine a biological component with a physicochemical detector. A biological signal is a signal within a living body that can be continuously measured and monitored and may refer to a bioelectrical signal, and may refer to both electrical and non-electrical signals (both may be time-varying signals). It will be understood that, according to a preferred embodiment, the sensor assembly 104 may include a synergistic combination of the electrical sensor device 404 and the magnetic sensor device 402.

[0042] 1C , the flexible medical guidewire assembly 102 (preferably) includes electrical wires 405 extending along (the length of) the flexible medical guidewire assembly 102. The electrical wires 405 are electrically connected to (coupled either directly or indirectly to) the sensor assembly 104. The electrical wires 405 extend from the sensor assembly 104 toward a terminal end of the flexible medical guidewire assembly 102 (e.g., the proximal end of the flexible medical guidewire assembly 102) and terminate at (a terminal point or terminal contact) the terminal end of the flexible medical guidewire assembly 102. The electrical wires 405 may be referred to as power lines. If the sensor assembly 104 includes multiple sensors, multiple electrical wires 405 are deployed (one for each deployed or attached sensor assembly). The wire 405 may comprise a miniaturized wire (e.g., about 34 to about 44 AWG (American Wire Gauge)) to free up cross-sectional space disposed within the flexible medical guidewire assembly 102. The wire 405 may comprise copper, stainless steel, nitinol, and the like. The wire 405 may comprise a flat ribbon wire having a rectangular cross-section with a thickness (e.g., about 0.002 inches or less), preferably to minimize the impact on the overall wire outer diameter, etc. The wire 405 may have a minimized total end-to-end DC resistance. The wire 405 may have a total end-to-end DC resistance (e.g., about 20 ohms or less).

[0043] 1C, the flexible medical guidewire assembly 102 is adapted (preferably) to not include electrical wires 405, and the sensor assembly 104 includes a wireless transmitter (known and not shown) configured to transmit a wireless signal. The wireless transmitter is located on the sensor assembly 104 (the wireless transmitter is an option to not using electrical wires 405). It will be understood that the wireless transmitter is the equivalent of the electrical wires 405.

[0044] Referring to the embodiment as shown in Figure ID, a flexible medical guidewire assembly 102 (preferably) includes a synergistic combination of a core element 106 and a jacket element 108. The core element 106 (also called a mandrel) is electrically conductive. The jacket element 108 is electrically insulating and surrounds the core element 106.

[0045] 1D , a tip portion 110 is positioned at the end sections of the core element 106 and the jacket element 108. A heating device 112 is attached to the tip portion 110 of the flexible medical guidewire assembly 102. The heating device 112 is electrically connected (and, for this embodiment, is electrically conductive) to the core element 106. A heating wire 113 is electrically connectable (and disconnectable) to the proximal end (user-accessible end) of the core element 106. According to a preferred embodiment, the heating device 112 includes (and is not limited to) an RF (radio frequency) emitter. The RF emitter is configured to provide (radiate) a sufficient amount of thermal energy to remove, cauterize, and / or puncture (preferably by a process of ablation) adjacently positioned tissue of the patient's body (the tissue being positioned adjacent (proximate) to the heating device 112 once the flexible medical guidewire assembly 102 is inserted into the enclosed space defined by the living body 902 and the heating device 112 is activated accordingly). Ablation involves the administration (application and / or removal) of thermal energy adjacent to the living tissue for the purposes of sealing blood vessels in the living tissue and preventing unwanted bleeding from the living tissue while creating voids, channels, and / or passages through the living tissue (thereby facilitating healing). Preferably, the proximal end of the core element 106 is configured to be electrically connectable to the heating wire 113 (the heating wire 113 is configured to supply electricity to the heating device 112 via the core element 106).According to a preferred embodiment, there is provided a flexible medical guidewire assembly 102 with at least one sensor assembly 104 in combination with a radio frequency emitter (which is a tissue piercing device), configured to emit a sufficient amount of thermal energy to ablate tissue (tissue wall) positioned proximate to the radio frequency emitter (thereby forming a hole or passage through the tissue or tissue wall), which provides a technical solution for using fewer fluoroscopy techniques and systems during medical procedures and / or treatments (this arrangement may reduce or eliminate the need for a switch between sensing and energy delivery). According to an embodiment, the heating device 112 is further configured to receive and / or record electrical signals and / or is configured for electrosurgical purposes.

[0046] With reference to the embodiment shown in FIG. 1D , the jacket element 108 may be referred to as an outer layer or an insulating layer (electrically insulating material or electrically insulating material). The jacket element 108 has, houses, or includes the electrical wires 405. For example, the jacket element 108 may include PTFE (extrusion of PTFE) and any equivalents thereof. Polytetrafluoroethylene (PTFE) is a synthetic fluoropolymer of tetrafluoroethylene. The jacket element 108 may include (define) at least one or more lumens (elongated spaces) configured to receive the electrical wires 405, etc.

[0047] Referring to the embodiment as shown in FIG. 1D, the heating device 112 (preferably) includes an electrode (also referred to as a distal electrode, a radio frequency (RF) electrode, etc.). The electrode may include stainless steel, nitinol, platinum, and iridium alloys (blends), or mixtures thereof. The electrode (preferably) may form a hemispherical dome geometry having a diameter (e.g., about 0.015 inches to about 0.032 inches, more preferably about 0.024 inches in diameter). The exposed metal (conductive) region is preferably sized from about 1.2 millimeters (mm^2) to about 2.4 mm^2 to ensure a relatively high current density when delivered in a monopolar manner (i.e., to a grounded patient) of about 270 Vrms (Volts Root Mean Square) to about 400 Vrms (once the flexible medical guidewire assembly 102 is inserted into the enclosed space defined by the living body 902 and once the heating device 112 is activated) to achieve tissue puncture (RF puncture) of adjacently positioned tissue of the patient. The electrode may be configured to provide a smooth surface so that the electrode does not inadvertently mechanically puncture the tissue. The electrode preferably becomes effectively sharp (to remove tissue) once RF energy is applied to the electrode and transmitted to the tissue.

[0048] With reference to the embodiment shown in FIGS. 1A, 1B, 1C, and 1D, the following describes additional technical features for an embodiment of the flexible medical guidewire assembly 102. It will be understood that these are preferred embodiments and are not required for the flexible medical guidewire assembly 102. Preferably, the flexible medical guidewire assembly 102 is configured for medical device exchange (such as a catheter exchange). Preferably, the working length of the flexible medical guidewire assembly 102 can be sufficient for medical device exchange (the guidewire length can double as long as the medical device is exchanged by utilizing the flexible medical guidewire assembly 102). Preferably, the flexible medical guidewire assembly 102 is configured for transseptal exchange. Preferably, the flexible medical guidewire assembly 102 has a bending stiffness (preferably between about 0.001 Nm2 (Newtons per square meter pressure units) and about 0.002 Nm2 along the majority of the length of the flexible medical guidewire assembly 102). Preferably, the flexible medical guidewire assembly 102 has a stiffness similar to (equivalent to) a standard 304 spring-tempered stainless steel wire (e.g., approximately 0.018 inch diameter) in the region of the flexible medical guidewire assembly 102 positioned across the atrial septum (of the heart). It will be appreciated that this preference may depend on many anatomical and environmental conditions, with some procedures benefiting from higher stiffness and some from lower stiffness. Preferably, the flexible medical guidewire assembly 102 may include a core element 106 (also referred to as a rigid core mandrel) with a jacket element 108 (also referred to as a flexible jacket layer) placed or positioned thereon to improve shape retention and / or provide a smooth overall elongated profile. According to embodiments, core element 106 has an outer diameter range (eg, about 0.015 inches to about 0.030 inches). According to embodiments, core element 106 comprises stainless steel and / or nitinol.According to embodiments, jacket element 108 comprises a material that provides a minimal contribution to the stiffness of flexible medical guidewire assembly 102. According to embodiments, jacket element 108 comprises an electrically insulating material, such as PTFE (polytetrafluoroethylene). According to embodiments, jacket element 108 comprises a flexible steel coil. According to embodiments, jacket element 108 has a thickness such that the outer diameter of flexible medical guidewire assembly 102 ranges from about 0.032 inches to about 0.035 inches.

[0049] According to embodiments, the distal end of the flexible medical guidewire assembly 102 is curved and flexible to protect the patient's tissue during advancement of the flexible medical guidewire assembly 102 through the patient's blood vessels. According to embodiments, the flexible medical guidewire assembly 102 includes a radio-visible material. According to embodiments, the flexible medical guidewire assembly 102 is configured to withstand handling (such as user and / or environmental forces) experienced during a medical (cardiac) procedure (therapeutic or diagnostic procedure). According to embodiments, the flexible medical guidewire assembly 102 complies with mandated international medical standards for a minimum pull force, such as about 10 N (Newtons), for medical guidewires sized in the range of about 0.032 inches to about 0.035 inches (preferably without loosening or separation of segments or portions of the flexible medical guidewire assembly 102). According to embodiments, the electrical connections of the flexible medical guidewire assembly 102 (at the distal end) require sufficient electrical insulation end-to-end to mitigate interference (environmental interference). According to embodiments, the flexible medical guidewire assembly 102 complies with international medical standards for electrosurgical devices, which provide minimum electrical insulation performance for the guidewire (for the protection of the patient and / or medical personnel). According to embodiments, the flexible medical guidewire assembly 102 includes a radio frequency (RF) device (also referred to as a heating device) configured to deliver approximately 270 Vrms to 400 Vrms (Vrms root mean square) (preferably in a monopolar configuration) for distal tissue puncture or tissue removal. According to an embodiment, flexible medical guidewire assembly 102 includes jacket element 108, which includes an insulating material having a thickness of about 0.00275 inches (e.g., PTFE) or greater, and jacket element 108 is positioned over any voltage-conducting conductors (such as core element 106, or other electrical wires, etc.) positioned within flexible medical guidewire assembly 102 to meet current leakage requirements. For example, the maximum dimension of core element 106 may be about 0.029 inches so that the outer diameter of flexible medical guidewire assembly 102 (preferably) remains less than about 0.035 inches.According to embodiments, the jacket element 108 includes a relatively thick electrical insulation (for ease of manufacturing). The thickness can be sized to vary the effective outer diameter of the flexible medical guidewire assembly 102. For example, if the core element 106 has a diameter of (preferably) approximately 0.018 inches and is made of stainless steel material, the jacket element 108 includes a relatively thick PTFE layer to make the outer device diameter of the flexible medical guidewire assembly 102 (preferably) approximately 0.035 inches. According to embodiments, a sensor device (medical sensor, electrode, etc.) is positioned in the flexible medical guidewire assembly 102. For example, the sensor device may be configured for low-voltage electrical communication (such as for ECG recording), in which case relatively thick insulation is not required and the sensor device may be protected from primary energy sources and interference (preferably end-to-end). According to embodiments, the flexible medical guidewire assembly 102 can be biocompatible, steerable, and robust.

[0050] 2A and 2B show front views of an embodiment of the flexible medical guidewire assembly 102 of FIGS. 1A, 1B, 1C, and / or 1D. Referring to the embodiment shown in FIG. 2A , the signal measurement system 904 (also referred to as a signal analysis system) is configured to be electrically connectable (selectively electrically connectable or coupled) to the sensor interface system 906. The definition of “electrically connected” includes electromagnetically connected, magnetically connected, acoustically connected, optically connected, and the like. The signal measurement system 904 may include, for example, an electromagnetic system, an electroanatomical mapping system (3D or 2D), or an electroanatomical non-fluoroscopic mapping system, and the like. The sensor assembly 104 includes the magnetic sensor device 402 (e.g., according to and as shown in FIG. 2A ). The sensor interface system 906 is configured to interface with the sensor assembly 104. The sensor interface system 906 is configured to exchange (receive and / or transmit) signals (information) with the sensor assembly 104 (once the sensor interface system 906 is interfaced with the sensor assembly 104 and once the sensor assembly 104 is activated). The exchange of signals may include having the sensor interface system 906 transmit signals to and / or receive signals from the sensor assembly 104. For embodiments such as that shown in FIG. 2A, the sensor assembly 104 includes a magnetic device, and the sensor interface system 906 is configured to magnetically interact with the sensor assembly 104.

[0051] Referring to the embodiment shown in FIG. 2B, the flexible medical guidewire assembly 102 includes electrical wires 405 (not shown in FIG. 2B, but shown in the embodiment of FIG. 1C). The sensor assembly 104 (preferably) includes an electrical sensor device 404. The flexible medical guidewire assembly 102 includes an electrical connector 810. Embodiments of the electrical connector 810 are shown in FIGS. 9B, 9C, 9D, 9E, 9F, 10A, 10B, 11A, 11B, 11C, 12A, 12B, and 12C. The electrical connector 810 is configured to be electrically connected (selectively connected and disconnected) to the electrical wires 405 of the flexible medical guidewire assembly 102. The electrical connector 810 is configured to be electrically connected (selectively connected and disconnected) to the sensor interface system 906. The sensor interface system 906 is configured to condition a signal received from the sensor assembly 104 and then provide the conditioned signal to a signal measurement system 904 (also referred to as a signal analysis system). According to one option, the sensor interface system 906 is configured to be electrically connected (selectively connected and disconnected) to the signal measurement system 904. According to another option, the sensor interface system 906 is electrically connected to the signal measurement system 904. The electrical connector 810 is configured to be in electrical communication with the sensor assembly 104 (such as via the electrical wire 405 shown in FIG. 1C ) once connected (operably connected) thereto. The electrical connector 810 is also configured to be electrically connectable with the sensor interface system 906. Preferably, the grounding element 908 (grounding pad) is configured to be removably adhered or in intimate, detachable contact with the living body 902 (preferably, to the skin of the living body 902). The grounding element 908 is spaced apart from the sensor assembly 104. The ground element 908 is (preferably) positioned proximate to the sensor assembly 104 (in the zone of interest for acquiring signals via the sensor assembly 104).The sensor interface system 906 is configured to electrically communicate with the sensor assembly 104 once (A) the sensor interface system 906 is electrically connected to the electrical wires 405 (via the electrical connector 810) and (B) the grounding element 908 is placed to mimic physical contact with the living body 902.

[0052] FIG. 3 shows a front perspective view of an embodiment of the flexible medical guidewire assembly 102 of FIG. 1D (some of the technical features as shown in FIG. 3 may be applicable to embodiments as shown in FIGS. 1A, 1B, and 1C, where applicable).

[0053] Referring to the embodiment as shown in FIG. 3 , the flexible medical guidewire assembly 102 is configured to provide (include) a heating device 112 (according to a preferred embodiment). The heating device 112 is configured to emit RF (radio frequency) energy from (the distal end of) the flexible medical guidewire assembly 102 and into adjacently positioned tissue of a living body 902 (e.g., as shown in the embodiment of FIG. 2B ). The core element 106 provides a relatively rigid, electrically conductive material (positioned along a central radial axis extending along the length of the flexible medical guidewire assembly 102). The jacket element 108 includes an electrically insulating material (preferably a polymer layer) covering the core element 106. The jacket element 108 (preferably) further includes an outer polymer layer covering the jacket element 108 (optionally). For example, jacket element 108 may comprise a wiring, cable, or other suitable material with electrical insulating properties suitable for electrical shielding duty, having sufficient performance characteristics for safety (dielectric strength, thermal performance, insulation and corrosion, water and heat resistance) to comply with industrial and regulatory safety standards. For considerations in selecting suitable materials, see the following publication: Plastics in Medical Devices: Properties, Requirements, and Applications, 2nd Edition, Author: Vinny R. Sastri, Hardcover ISBN: 9781455732012, Published: November 21, 2013, Publisher: Amsterdam [Pays-Bas]: Elsevier / William Andrew,

[2014] . Core element 106 terminates in (and electrically connects to) a heating device 112 (also referred to as a smooth dome-shaped electrode) positioned at the distal end of flexible medical guidewire assembly 102. The heating device 112 is configured (once activated accordingly) to pierce tissue of the living body 902. The core element 106 further includes a core terminal portion 106A extending from the proximal end of the core element 106. The core terminal portion 106A is exposed (at least partially not covered by an electrically insulating material).The core terminal portion 106A is configured to be electrically connected to ancillary equipment (such as an RF generator, etc., known and not shown). The flexible medical guidewire assembly 102 (as shown in FIG. 3 ) is configured to perform (form) an RF (radio frequency) puncture (useful for forming a transseptal puncture, etc.) within a patient's tissue. A technical effect or advantage of the heating device 112 is that the heating device 112 may reduce the number of medical device exchanges (insertion and removal of the flexible medical guidewire assembly 102 within a confined space defined by the living body 902), as may be required for, for example, a TSP (transseptal puncture) and cardiac catheterization procedures (which require the heating device 112). It may be in the interest of both the patient (living body 902) and the physician to minimize medical device exchanges within the patient's body to reduce the risk of undesired medical occurrences or conditions, such as air embolism, etc. For the preferred embodiment as shown in FIG. 3 , the core element 106 is electrically conductive, and the heating device 112 is electrically connected to the core element 106.

[0054] 3, the jacket element 108 is configured to electrically insulate (provide electrical insulation) from the core element 106. To provide electrical safety to the patient and user (such as a physician or medical technician handling the flexible medical guidewire assembly 102) and additionally to provide effective current delivery to the heating device 112 (such as a distal electrode configured for radio frequency (RF) tissue ablation and / or tissue cauterization, etc.), the core element 106 (or an equivalent alternative high voltage wireline) may require a significant amount of electrical insulation. PTFE is a preferred material for high voltage RF insulation due to its relatively high electrical performance, biocompatibility, and flexibility. PTFE is also available as a heat shrink material (form) to ensure conformal adhesion to the core element 106 (electrically energized mandrel) to efficiently use the available space in the flexible medical guidewire assembly 102 (i.e., reduce the space consumed by the gap between the electrical wires and the hollow elongated extrusion void or lumen extending therein along the longitudinal length of the flexible medical guidewire assembly 102). The flexible medical guidewire assembly 102 may have an outer diameter of approximately 0.035 inches and may require an effective insulation wall thickness of approximately 0.003 inches of PTFE material to meet the current (amperage) leakage requirements of electrosurgical standards. Preferably, the maximum inner diameter of the core element 106 is approximately 0.029 inches (subject to what can be allowed within manufacturing tolerances).

[0055] Referring to the embodiment as shown in FIG. 3, the sensor assembly 104 includes at least one electrical sensor. Referring to the embodiment shown in FIG. 3 , the sensor assembly 104 (such as an electrical sensor) includes a first electrical sensor device 404A (also referred to as a proximal electrode) and an Nth electrical sensor device 404N (where N is 1, 2, 3, or any other integer). The first electrical sensor device 404A and the Nth electrical sensor device 404N are spaced apart from one another and fixedly positioned along the longitudinal length of the flexible medical guidewire assembly 102 (each of the electrical sensor devices is spaced apart from one another). According to a preferred option, the first electrical sensor device 404A and the Nth electrical sensor device 404N are (preferably) disposed on the outer surface of the jacket element 108. A first electrical wire 405A is electrically connected to the first electrical sensor device 404A (etc.). The first electrical wire 405A is embedded within the flexible medical guidewire assembly 102. The first electrical wire 405A extends along the length of the flexible medical guidewire assembly 102 from the first electrical sensor device 404A to the proximal end of the flexible medical guidewire assembly 102 (the terminal end), and similarly for the other electrical wires. The Nth electrical wire 405N (Nth electrical wire) is electrically connected to the Nth electrical sensor device 404N. The Nth electrical wire 405N (Nth electrical wire) extends along the length of the flexible medical guidewire assembly 102 from the Nth electrical sensor device 404N to the proximal end (terminal end) of the flexible medical guidewire assembly 102. The Nth electrical wire 405N is embedded within the flexible medical guidewire assembly 102. A jacket element 108 (electrical insulating layer) covers and electrically insulates the first electrical wire 405A and the Nth electrical wire 405N. The first electrical wire 405A and the Nth electrical wire 405N are aligned parallel to the core element 106. The first electrical wire 405A and the Nth electrical wire 405N terminate at the core terminal portion 106A. According to a preferred embodiment (as shown in FIG. 3), the heating device 112 and the plurality of electrical sensor devices (404A, 404N) are electrically isolated from each other (to avoid electrical and / or magnetic interference between these devices).For considerations in selecting materials suitable for electrical insulation, reference is made to the following publication: Plastics in Medical Devices: Properties, Requirements, and Applications, 2nd Edition, Author: Vinny R. Sastri, Hardcover ISBN: 9781455732012, Published: November 21, 2013, Publisher: Amsterdam [Pays-Bas]: Elsevier / William Andrew,

[2014] .

[0056] Referring to the embodiment as shown in Figure 3, core terminal portion 106A (proximal electrical connection) is located at the terminal end of core element 106. Core terminal portion 106A is exposed for electrical connection to a measurement system (via electrical wiring), as shown in the embodiment of Figure 2B. Preferably, core terminal portion 106A extends (axially) from the end section of core element 106.

[0057] Referring to the embodiment as shown in FIG. 3, the electrical sensor devices (404A, 404N) may include conductive rings configured to fit over the outer surface of the jacket element 108.

[0058] The electrical sensor devices (404A, 404N) may be swaged or glued to the outer surface of the flexible medical guidewire assembly 102. The electrical sensor devices (404A, 404N) may include gold and / or steel.

[0059] 3 , the sensor assembly 104 (electrical sensor device) may include at least one exposed portion of an electrical wire 405, such as a portion of the electrical wire (405A, 405N) exposed to (or positioned on) the exterior surface of the flexible medical guidewire assembly 102. The exposed portion of the electrical wire 405 is exposed without the jacket element 108 being positioned over the exposed portion of the electrical wire 405. In this manner, exposure of the electrical wire 405 to tissue (e.g., a patient's bloodstream) may provide electrical communication and signal sensing functionality for use with other medical equipment (e.g., electrocardiogram machines, etc.). It will be appreciated that when the electrical wire 405 persists within and along the length of the flexible medical guidewire assembly 102, a window is formed through the jacket element 108 that may expose the electrical wire 405 to function as the sensor assembly 104 (electrode, etc.). In this manner, the sensor assembly 104 may include an exposed portion of the electrical wires 405 (ie, the electrical wires 405 are exposed outside the jacket element 108).

[0060] 3, the sensor assembly 104 (according to one embodiment) includes an exposed portion of an electrical wire 405 exposed on the outer surface of the flexible medical guidewire assembly 102. The electrical wire 405 extends along the length of the flexible medical guidewire assembly 102. The electrical wire 405 extends toward a terminal end of the flexible medical guidewire assembly 102. The electrical wire 405 terminates (is electrically connected to) a terminal contact located or disposed at an end portion of the flexible medical guidewire assembly 102.

[0061] FIG. 4 shows a front perspective view of an embodiment of the flexible medical guidewire assembly 102 of FIG. 1D (some of the technical features as shown in FIG. 4 may be applicable to embodiments as shown in FIGS. 1A, 1B, and 1C, where applicable).

[0062] 4, the first electrical sensor device 404A and the Nth electrical sensor device 404N are countersunk (positioned) beneath the outer diameter (outer surface) of the jacket element 108. The technical effect of this arrangement is to allow relatively easy sliding movement of the flexible medical guidewire assembly 102 along the enclosed space defined by the living body 902 (as shown in the embodiment of FIG. 2A or 2B). In this embodiment (as shown in FIG. 4), the first electrical sensor device 404A and the Nth electrical sensor device 404N are configured to communicate signals to the external environment (for electrical recording by an external medical instrument, etc.) via electrical wires (405A, 405N) through spatially separated windows (voids) formed in the outermost layer (on) of the jacket element 108.

[0063] FIG. 5 shows a front perspective view of an embodiment of the flexible medical guidewire assembly 102 of FIG. 1D (some of the technical features as shown in FIG. 5 may be applicable to embodiments as shown in FIGS. 1A, 1B, and 1C, where applicable).

[0064] Referring to the embodiment as shown in FIG. 5, the flexible medical guidewire assembly 102 further includes (and is not limited to) a braided element 406 . The braided element 406 is positioned internally within the body of the flexible medical guidewire assembly 102. The braided element 406 may include a metal alloy. The braided element 406 is elastically flexible (elastically deformable). The braided element 406 includes braided wire having strands of wire braided together. The braided element 406 is positioned below the outer surface of the flexible medical guidewire assembly 102. The braided element 406 is spaced from (and surrounds) the core element 106. The braided element 406 is configured to improve the stiffness and / or torqueability of the flexible medical guidewire assembly 102. For example, if the diameter of the flexible medical guidewire assembly 102 (and therefore the stiffness of the core element 106) needs to be minimized, the braided element 406 can restore some of the stiffness of the flexible medical guidewire assembly 102.

[0065] 6A and 6B show an axial cross-sectional view (FIG. 6A) and a radial cross-sectional view (FIG. 6B) of an embodiment of the flexible medical guidewire assembly 102 of FIG. 1D (some of the technical features as shown in FIG. 6A and / or FIG. 6B may be applicable to embodiments as shown in FIG. 1A, FIG. 1B and FIG. 1C, where applicable).

[0066] 6A and 6B, the stiffness of the flexible medical guidewire assembly 102 is (preferably) provided by the electrical wires, such as a combination of the electrical wires (first electrical wire 405A, second electrical wire 405B, and Nth electrical wire 405N), and not by the core element 106 (or alternatively, the core element 106 is not provided). That is, the first electrical wire 405A, second electrical wire 405B, and Nth electrical wire 405N are relatively large in size (to add more stiffness to the flexible medical guidewire assembly 102), and the core element 106 may or may not be included in the flexible medical guidewire assembly 102. If the core element 106 is included (deployed), the core element 106 may be reduced in diameter to improve manufacturability and positioning of the first electrical sensor device 404A (proximal electrode) and the Nth electrical sensor device 404N (proximal electrode), etc. A core insulation layer 106B is positioned over the core element 106. A jacket portal 108A (void) is formed in a central zone of the jacket element 108 such that the core element 106, the first electrical wire 405A, the second electrical wire 405B, and the Nth electrical wire 405N are all positioned in the jacket portal 108A. A technical effect of this embodiment is that once the flexible medical guidewire assembly 102 is bent, the electrical wires can bend and flex without electrically disconnecting, shorting, or otherwise becoming disconnected.

[0067] According to the embodiment shown in FIGS. 6A and 6B , the diameter of the core element 106 (also referred to as the primary mandrel) is (preferably) reduced. For example, the core element 106 comprises an elongated wire (relatively thin wire for lower voltage capability) extending along the longitudinal length of the flexible medical guidewire assembly 102. The core element 106 comprises a relatively low surface area and / or diameter, and this arrangement provides additional room for other components (to be placed within and along the elongated length of the jacket element 108 (also referred to as the insulating layer)). The outer dimension (diameter) of the first electrical wire 405A may be increased to provide increased mechanical stiffness for the flexible medical guidewire assembly 102. To balance the stiffness profile of the flexible medical guidewire assembly 102 (to provide a relatively resilient tip portion, a relatively stiff proximal body portion, etc.), the core element 106 and / or The profile (outer diameter) of the wires 405 may vary along the longitudinal length of the flexible medical guidewire assembly 102. For example, longer instances of the core element 106 may include reduced outer diameters and cross-sectional areas along their lengths to provide desired flexibility (local flexibility) for selected portions of the flexible medical guidewire assembly 102. For example, the outer diameter of the core element 106 may increase toward the distal tip (of the flexible medical guidewire assembly 102) to improve anchoring and stiffness at the most distally positioned medical device (such as a medical sensor device).

[0068] Figures 7A, 7B, 7C, 7D and 7E show radial cross-sectional views of an embodiment of the flexible medical guidewire assembly 102 of Figure 1D (some of the technical features as shown in Figures 7A, 7B, 7C, 7D and / or 7E may be applicable to embodiments as shown in Figures 1A, 1B and 1C, where applicable).

[0069] 7A , a first wire insulation layer 407A is disposed over the first wire 405A and for each wire. A second wire insulation layer 407B is disposed over the second wire 405B. An Nth wire insulation layer 407N is disposed over the Nth wire insulation layer 407N. The core element 106 has an outer diameter larger than the outer diameters of the first wire 405A, the second wire 405B, and the Nth wire 405N. The core element 106, the first wire 405A, the second wire 405B, and the Nth wire 405N are disposed within the jacket portal 108A and are coaxially arranged along the length (longitudinal axis) of the flexible medical guidewire assembly 102. According to an embodiment, the core element 106, the first electrical wire 405A, the second electrical wire 405B, and the Nth electrical wire 405N are (preferably) electrically insulated from each other (and from the patient, etc.). According to another embodiment, the first electrical wire 405A, the second electrical wire 405B, and the Nth electrical wire 405N are (preferably) electrically insulated from each other and from the patient (in the case where the core element 106 is not electrically conductive). The flexible medical guidewire assembly 102 (preferably) has an outer diameter of about 0.032 inches to about 0.035 inches. The core element 106 (preferably) has or includes an outer diameter of about 0.018 inches (preferably of SAE304 spring-tempered stainless steel). An electrical insulation layer (also referred to as primary insulation, such as core insulation layer 106B as shown in FIG. 6B) is positioned over the core element 106 and (preferably) has a thickness of about 0.003 inches. The wires (405A, 405B, 405N, etc.) may have any suitable cross-section or profile, such as a circular cross-section or a rectangular cross-section. The wires (405A, 405B, 405N, etc.) may have a thickness dimension (diameter contribution) of about 0.002 inches. The wire insulation layer placed over each of the wires (405A, 405B, 405N, etc.) may have a thickness of about 0.003 inches (or more).

[0070] There is sufficient space within or on the flexible medical guidewire assembly 102 to allow a sensor device (e.g., also referred to as a ring electrode as shown in FIG. 6A ) to be placed. According to embodiments, the sensor device (proximal electrode) may be placed (positioned) in a relatively resilient section of the flexible medical guidewire assembly 102, where the outer diameter of the core element 106 is reduced to improve its resilience. The resilient region (of the flexible medical guidewire assembly 102) may comprise a stainless steel material (elongated mandrel) ranging from about 0.006 inches to about 0.010 inches in diameter. In this case, the diameter constraint is reduced to provide additional space for terminating a connector to the sensor device (proximal electrode), etc.

[0071] 7B, a core insulation layer 106B is positioned over the core element 106. A jacket portal 108A is disposed between the outer surface of the core insulation layer 106B and the inner surface of the jacket element 108. A first electrical wire 405A, a second electrical wire 405B, and an Nth electrical wire 405N are positioned in the jacket portal 108A (between the jacket element 108 and the core insulation layer 106B). The jacket portal 108A forms a multi-sided geometric shape (e.g., having multiple angled cross sections with the wires positioned at the vertices of the multi-sided geometric shape (e.g., a triangle)).

[0072] Referring to the embodiment shown in FIG. 7C, the core insulation layer 106B defines recesses configured to receive the respective electrical wires (405A, 405B, 405N) therein. The outer shape of the core insulation layer 106B has a circular or circular cross-sectional shape. The inner shape of the jacket element 108 has a circular or circular cross-sectional shape that matches the outer shape of the core insulation layer 106B. The core insulation layer 106B surrounds the core element 106.

[0073] Referring to the embodiment as shown in FIG. 7D, this embodiment provides a similar embodiment as shown in FIG. 7B with electrical wires (405A, 405B, 405N) each having a respective electrical insulation layer thereon (as shown in the embodiment of FIG. 7A).

[0074] 7E, the jacket element 108 defines (provides) jacket channels (first jacket channel 109A, second jacket channel 109B, and Nth jacket channel 109N). Each of the electrical wires (405A, 405B, 405N) is received in a respective jacket channel (109A, 109B, 109N). It will be understood that the core insulation layer 106B is optional in this embodiment.

[0075] According to the embodiment shown in Figures 7A-7E, increased relative movement (and / or slack therefor) between the electrical wires (405A, 405B, 405N) can provide additional flexibility for the flexible medical guidewire assembly 102. The core element 106 (which may be conductive, also referred to as a mandrel) is configured to provide the majority of the mechanical rigidity (with respect to the jacket element 108 and the electrical wires (405A, 405B, 405N)). The jacket element 108 (also referred to as a coating) is configured to provide sufficient electrical insulation to withstand relatively high voltages and / or currents for the core element 106. The electrical wires (405A, 405B, 405N) are electrically insulated (electrically isolated) from each other and from the core element 106. The electrical wires (405A, 405B, 405N) can be configured to handle relatively low voltages or relatively high voltages, etc. The jacket element 108 may be flexible and may be lubricious (may be smooth and slippery with oil or similar substance).

[0076] Figures 8A and 8B show radial cross-sectional views of an embodiment of the flexible medical guidewire assembly 102 of Figure 1D (some of the technical features as shown in Figures 8A and / or 8B may be applicable to embodiments as shown in Figures 1A, 1B and 1C, where applicable).

[0077] Referring to the embodiment shown in FIG. 8A , the jacket element 108 defines (forms) a jacket portal 108A (having a circular cross-sectional profile). A core insulation layer 106B is placed over the core elements 106, each of which has a semicircular cross-sectional profile. The core elements 106 form an offset (non-circular) shape. The core element 106 and the core insulation layer 106B are received in at least a portion of the jacket portal 108A, and a portion of the jacket portal 108A is open and available to receive the wires (405A, 405B, 405N). Each of the wires (405A, 405B, 405N) has an electrical insulation layer (such as first wire insulation layer 407A, etc.). The core element 106 forms a shape configured to provide additional space to improve the manufacturability and scalability of the wires (405A, 405B, 405N).

[0078] 8B, the core insulation layer 106B forms a cavity configured to receive the electrical wires (405A, 405B, 405N). The core insulation layer 106B forms two cavities, one cavity for receiving the core element 106 and the other cavity for receiving the electrical wires (405A, 405B, 405N).

[0079] Figure 9A shows a side view of an embodiment of the flexible medical guidewire assembly 102 of Figure 1D (some of the technical features as shown in Figure 9A may be applicable to embodiments as shown in Figures 1A, 1B, and 1C, where applicable). Figures 9B, 9C, 9D, 9E, and 9F show side views of embodiments of an electrical connector 810 configured to be connectable to the flexible medical guidewire assembly 102 of Figure 9A.

[0080] 9A , the core terminal portion 106A extends (extends axially) from an end portion (proximal or user-accessible portion) of the core element 106. The core terminal portion 106A is exposed (for electrical connection if the core terminal portion 106A is conductive). The flexible medical guidewire assembly 102 includes at least one terminal portion 409. The terminal portion 409 may include the core element 106 (if the core element 106 is required to be conductive).

[0081] 9B and 9C, an electrical connector 810 is configured to be selectively electrically connected (clip-on) to the core terminal portion 106A. The electrical connector 810 may include a clip connector, an alligator clip, etc., and any equivalents thereof. The electrical connector assembly 810 includes a connector terminal 811 (electrical connector contacts, jaw portion, etc.), such as a pair of opposing jaws (normally closed, spring-loaded, etc.). According to an embodiment, the electrical connector assembly 810 is configured to connect to an electrical terminal (terminal portion 409, electrical connection) located at the proximal end of the flexible medical guidewire assembly 102. The electrical terminal is electrically connected to, for example, an electrical sensor device 404A and / or a medical device (such as the heating device 112) as shown in FIG. 3 and elsewhere, attached to a portion (such as the distal portion) of the flexible medical guidewire assembly 102. The electrical connector assembly 810 is also configured to connect an electrical terminal of an external device (such as a signal generator or signal recording system, known and not shown) to the electrical terminal (at least one instance of terminal portion 409) of the flexible medical guidewire assembly 102. This is preferably done so that the nominal diameter of the flexible medical guidewire assembly 102 can be maintained (e.g., about 0.032 inches to about 0.035 inches, etc.). Preferably, the electrical connector assembly 810 provides conductive pins configured to facilitate electrical connection with the electrical terminal (terminal portion 409) of the flexible medical guidewire assembly 102 with a single user action (for convenience). Alternatively, the electrical connector assembly 810 is configured to provide conductive pins configured to facilitate electrical connection between the electrical terminal of the flexible medical guidewire assembly 102 and multiple selective independent connections, etc.

[0082] Referring to the embodiment shown in FIG. 9D, core terminal portion 106A extends axially from an end portion of core element 106. Core terminal portion 106A is exposed for electrical connection (if core terminal portion 106A is conductive, or otherwise). At least one terminal portion (409A, 409B, 409N) (also referred to as a proximal electrical connector or wire terminal) is electrically coupled to a respective electrical sensor device (404A, 404N) shown in any one of the embodiments of FIG. 3, FIG. 4, and / or FIG. 5. For example, first terminal portion 409A (wire terminal, proximal connection) is electrically coupled to first electrical sensor device 404A (via first electrical wire 405A, as shown in FIG. 3). The second terminal portion 409B (proximal electrode) is electrically coupled to a second electrical sensor device (not shown, but easier to visualize when considering the first electrical sensor device 404A) via a second electrical wire 405B. The Nth terminal portion 409N (proximal connection) is electrically coupled to the Nth electrical sensor device 404N (via the Nth electrical wire 405N). The terminal portions (409A, 409B, 409N) are spaced apart (axially spaced apart) from one another along the length of the jacket element 108 and are positioned on the outer surface of the jacket element 108 proximate to the end portion (near the location of the core terminal portion 106A) of the flexible medical guidewire assembly 102. According to a preferred embodiment, the flexible medical guidewire assembly 102 is configured to facilitate catheter exchange by having a proximal end (user access end portion) that does not have a handle to allow a catheter to pass through the length (full length) of the flexible medical guidewire assembly 102; if a handle is positioned at the proximal end, a catheter may not then be able to pass through the length of the flexible medical guidewire assembly 102. According to a preferred embodiment, the flexible medical guidewire assembly 102 includes multiple instances of the sensor assembly 104, where the sensor assembly 104 is connectable to a measurement device (as shown in FIG. 2A or 2B ).

[0083] 9E and 9F, an electrical connector assembly 810 includes a connector terminal 811. The connector terminal 811 is configured to be selectively electrically connectable to (and selectively electrically disconnectable from) at least one terminal portion 409 of the flexible medical guidewire assembly 102. The flexible medical guidewire assembly 102 is configured to be inserted into a closed space defined by a living body 902 (as shown in FIG. 2A or 2B). The terminal portion 409 (also referred to as a wire terminal) is electrically connected to (supported by) the sensor assembly 104 of the flexible medical guidewire assembly 102 (as shown in FIG. 1C or 1D, among others) via an electrical wire 405.

[0084] 9E and 9F , electrical connector assembly 810 is configured to selectively electrically connect to (and selectively electrically disconnect from) terminal portions (409A, 409B, 409N, 106A) (electrical terminals, exposed electrical terminals) of (preferably) flexible medical guidewire assembly 102. The terminal portions may include, for example, core terminal portion 106A (when core terminal portion 106A is conductive) and terminal portions (409A, 409B, 409N) (also referred to as electrical portions, multiple proximal electrodes, etc., that may be utilized for sensor devices, etc.). When core terminal portion 106A is not needed (not deployed as an electrical wire), electrical connector assembly 810 is configured to selectively electrically connect to (and selectively electrically disconnect from) terminal portions (409A, 409B, 409N), or at least one or more terminal portions, connected to at least one electrical sensor device 404 (as shown in FIG. 3 ). The electrical connector assembly 810 includes connector wires 812, such as connector wires (812A, 812B, 812D, 812N). The connector wires 812 are (preferably) of sufficient length to provide a sufficient amount of slack for spatial movement of the flexible medical guidewire assembly 102 (i.e., to provide breakouts for radio frequency generators, signal recording systems, and other auxiliary medical instruments). The connector wires 812 (preferably) include multiple connector wires (812A, 812B, 812D, 812N). Selective disconnection and removal of the electrical connector assembly 810 from the terminal portions (409A, 409B, 409N, 106A) of the flexible medical guidewire assembly 102 allows the flexible medical guidewire assembly 102 to be utilized with a medical instrument 900 (as shown in FIG. 1 ) and / or with other medical devices, such as catheters (such as for catheter exchange duty), etc.

[0085] 9E and 9F , an electrical connector assembly 810 includes connector terminals 811 (e.g., a first connector terminal 811A, a second connector terminal 811B, and an Nth connector terminal 811N). The connector terminals 811 are configured to be electrically connectable with at least one terminal portion 409 of a flexible medical guidewire assembly 102. The flexible medical guidewire assembly 102 is configured to be inserted into a closed space defined by a living body 902 (as previously described and shown in FIG. 2A or 2B ). The terminal portion 409 is exposed (electrically exposed) for electrical connection to the connector terminals 811. The terminal portion 409 (electrical terminal) is electrically connected to the sensor assembly 104 (e.g., as shown in the embodiment of FIG. 3 ) via an electrical wire 405. The terminal portion 409 is positioned at the proximal end of the flexible medical guidewire assembly 102. Terminal portion 409 is exposed for selective electrical connection to electrical connector assembly 810. Sensor assembly 104 and electrical wire 405 are supported by flexible medical guidewire assembly 102 (this is done so that once flexible medical guidewire assembly 102 is inserted into and moved along the enclosed space defined by living body 902, sensor assembly 104 and flexible medical guidewire assembly 102 are movable along the enclosed space defined by living body 902).

[0086] 9E and 9F , connector terminal 811 (of electrical connector assembly 810) preferably includes connector terminals (811A, 811B, 811N, 811D) for each terminal portion (409A, 409B, 409N, 106A). Core terminal portion 106A may be utilized or deployed as an electrical wire when a heater device or other medical device is deployed in or with flexible medical guidewire assembly 102. For example, connector terminals (811A, 811B, 811N, 811D) preferably include a first pair of jaws (for electrical connection with first terminal portion 409A), a second pair of jaws (for electrical connection with second terminal portion 409B), an Nth pair of jaws (for electrical connection with Nth terminal portion 409N), and a pair of core jaws (for electrical connection with core terminal portion 106A). The connector wires (812A, 812B, 812D, 812N) (electrical connector wires) are electrically connected to the connector terminals (811A, 811B, 811N, 811D), respectively. The first connector wire 812A is electrically connected to the first connector terminal 811A. The second connector wire 812B is electrically connected to the second connector terminal 811B. The Nth connector wire 812N is electrically connected to the Nth connector terminal 811N. The fourth connector wire 812D is electrically connected to the third connector terminal 811D (to connect to the core terminal portion 106A).

[0087] 9E and 9F, electrical connector assembly 810 includes a side-loading removable electrical connector that includes and supports, for example, a plurality of spaced-apart alligator clips attached to (or extending from) electrical connector assembly 810.

[0088] Referring to the embodiment shown in FIG. 9F, electrical connector assembly 810 includes an asymmetrical hair clip-style connector with hard stops and variable gaps formed in the alligator teeth to mitigate misconnections and ensure proper electrical connection to electrical sensor devices (404A, 404N), as shown in FIG. 3. Connector terminal 811A is keyed for keyed connection to first terminal portion 409A. Third connector terminal 811D (e.g., jaw) is keyed for keyed connection to core terminal portion 106A. Third connector terminal 811D is unused when core terminal portion 106A is not deployed as an electrical wire, etc.

[0089] 9F, an electrical connector assembly 810 includes a handle 814 extending from a housing assembly 816. A first connector terminal 811 is supported by the housing assembly 816. A connector wire 812 is supported by the housing assembly 816.

[0090] Figures 10A and 10B show side views of an embodiment of an electrical connector 810 configured to be connectable to the flexible medical guidewire assembly 102 of Figure 1D (some of the technical features as shown in Figures 10A and / or 10B may be applicable to embodiments as shown in Figures 1A, 1B, and 1C, where applicable).

[0091] 10A , an electrical connector assembly 810 is configured to electrically interface with an end portion (proximal end portion) of a flexible medical guidewire assembly 102. The electrical connector assembly 810 is configured to back-load onto the flexible medical guidewire assembly 102. The electrical connector assembly 810 defines (provides) a connector channel 824 configured to receive (at least partially, axially receive) the length of the end portion of the flexible medical guidewire assembly 102. The electrical connector assembly 810 includes a push button 820 positioned on a surface (e.g., a top surface) of the electrical connector assembly 810. The electrical connector assembly 810 includes connector conductors 822 (electrodes, etc.). The push button 820 is configured to (A) be actuated by a user (physician, etc.) to selectively move the connector conductors 822 and (B) selectively connect the connector conductors 822 with a terminal portion (such as the core terminal portion 106A) of the flexible medical guidewire assembly 102 once the end portion of the flexible medical guidewire assembly 102 is received in the connector channel 824 (and once the push button 820 is actuated accordingly).

[0092] Referring to the embodiment shown in FIG. 10A , electrical connector assembly 810 is also configured to provide an over-the-wire connector. The top case of electrical connector assembly 810 is shown in a loaded position (unactuated), where push button 820 is not depressed or actuated by a user (e.g., a physician). The bottom case of electrical connector assembly 810 is shown in a locked and engaged position, where push button 820 is engaged or actuated. In the top case of electrical connector assembly 810, push button 820 is ready to be depressed (by a user or physician). Once push button 820 is depressed (as shown in the bottom case of electrical connector assembly 810), connector conductor 822 is clamped (electrically engaged) to terminal portion 409 (e.g., core terminal portion 106A) with the assistance of spring member 818. It will be appreciated that the same mechanism may be utilized if multiple instances of terminal portion 409 are present. Each unique electrical connection (i.e., for each instance of terminal portion 409) may require independent movement to ensure full connection between each connector face and the respective terminal portion of flexible medical guidewire assembly 102. Alternatively, a biased connection to terminal portion 409 (such as core terminal portion 106A) may ensure that connection is possible only after other terminal portions (of flexible medical guidewire assembly 102) have made electrical contact, etc., with electrical components of electrical connector assembly 810.

[0093] 10B, the upper case of the electrical connector assembly 810 is shown in a loaded position (i.e., the electrical connector assembly 810 is ready to receive the end portion of the flexible medical guidewire assembly 102). The lower case of the electrical connector assembly 810 is shown in a locked and engaged position (the electrical components of the electrical connector assembly 810 are in electrical contact with the terminals of the flexible medical guidewire assembly 102). The connector channel 824 is formed as a complementary contour 826. The complementary contour 826 has a shape that is complementary to the outer contour of the end portion of the flexible medical guidewire assembly 102. The push button 820 is configured to move (in tandem) the upper electrical terminal including a first pole 828A (for use with the first terminal portion 409A) and a second pole 828B (for use with the core terminal portion 106A). The first pole 828A and the second pole 828B are spaced apart from each other.

[0094] 10A and 10B, each unique electrical connection can be provided with an independent movement to ensure a (full) electrical connection with each connector face (of the wire). Alternatively, a bias connection can be provided to the core element 106 to ensure an electrical connection that is only possible after the other poles have been contacted.

[0095] Figures 11A and 11B show perspective views of an embodiment of the flexible medical guidewire assembly 102 of Figure 1D (some of the technical features as shown in Figures 11A, 11B, and / or 11C may be applicable to embodiments as shown in Figures 1A, 1B, and 1C, where applicable). Figure 11C shows a side view of an embodiment of an electrical connector 810 configured to be connectable to the flexible medical guidewire assembly 102 of Figure 11A and / or 11B.

[0096] 11A and 11B, the end portion (proximal end or user-accessible portion, etc.) of the flexible medical guidewire assembly 102 includes (provides) a flat radial end surface 911. The flat radial end surface 911 faces axially along an axial axis extending outward from the end portion of the flexible medical guidewire assembly 102. The first terminal portion 409A includes a first ridge (axially extending post) extending axially (i.e., extending from the jacket element 108) from (away from) the flat radial end surface 911. The second terminal portion 409B includes a second ridge (axially extending post) extending axially (i.e., extending from the jacket element 108) from (away from) the flat radial end surface 911. The Nth terminal portion 409N includes an Nth protuberance (axially extending post) (extending from the jacket element 108) extending axially from (away from) the flat radial end surface 911. The first terminal portion 409A, the second terminal portion 409B, and the Nth terminal portion 409N are each electrically connected to an associated electrical sensor device (such as electrical sensor device 404A as shown in FIG. 3 ) and are spaced apart from one another (preferably equidistant from one another). The core terminal portion 106A extends axially from the core element 106 and away from the flexible medical guidewire assembly 102 (along the same direction as the alignment of the terminal portions (409A, 409B, 409N)).

[0097] 11B , the end portion (proximal portion) of the flexible medical guidewire assembly 102 includes a flat radial end surface 911 (rear plane, end surface, etc.) that faces along an axial axis extending from the end portion of the flexible medical guidewire assembly 102. The first terminal portion 409A includes a first flattened end terminal portion that extends radially (at least partially) along the flat radial end surface 911. The second terminal portion 409B includes a second flattened end terminal portion that extends radially (at least partially) along the flat radial end surface 911. The Nth terminal portion 409N includes an Nth flattened end terminal portion that extends radially (at least partially) along the flat radial surface 911.

[0098] Referring to the embodiment shown in FIG. 11C, the electrical connector assembly 810 is configured to interact (electrically interface) with the terminal portions (409A, 409B, 409N) of the embodiment shown in FIG. 11A and / or FIG. 11B. The terminal portions (409A, 409B, 409N) are positioned on the flat radial end surface 911 as shown in FIG. 11A and / or FIG. 11B. The electrical connector assembly 810 includes axially extending wire connections 832 (spring-loaded conductive elements or rods) each having a respective spring member 833. Each respective spring member 833 is configured to bias an extension of the axially extending wire connection 832 outwardly away from the electrical connector assembly 810. Each respective spring member 833 is positioned within a connector channel 824 defined by the electrical connector assembly 810.

[0099] 11C, push button 820 is mounted on the exterior of the housing of electrical connector assembly 810. Push button 820 is configured to selectively lock (and selectively unlock) to the end portion (proximal end) of flexible medical guidewire assembly 102. It will be appreciated that in some embodiments, flexible medical guidewire assembly 102 includes core terminal portion 106A, which is electrically conductive, where core element 106 is also electrically conductive, etc. Once push button 820 is actuated (by a user, physician, etc.), push button 820 selectively locks (securely connects) electrical connector 810 to the end portion of flexible medical guidewire assembly 102, causing radially extending wire connections 832 to make electrical contact with terminal portions (409A, 409B, 409N, 106A), etc. A spring member 818 (also called a compression spring) is positioned in the electrical connector 810 and is configured to bias the connector conductor 822 (across the axial axis of the flexible medical guidewire assembly 102) against the core terminal portion 106A (once the end portion of the flexible medical guidewire assembly 102 is inserted into the connector channel 824 of the electrical connector 810).

[0100] Figure 12A shows a perspective view of an embodiment of the flexible medical guidewire assembly 102 of Figure 1D (some of the technical features as shown in Figures 12A, 12B and / or 12C may be applicable to embodiments as shown in Figures 1A, 1B and 1C, where applicable). Figures 12B and 12C show side views of an embodiment of an electrical connector 810 configured to be connectable to the flexible medical guidewire assembly 102 of Figure 12A.

[0101] 12A , the flexible medical guidewire assembly 102 includes a plurality of terminal portions (409A, 409B, 409N, 106A) positioned (preferably) at a terminal end portion (proximal end portion or user-accessible portion) of the flexible medical guidewire assembly 102. According to a preferred embodiment, the plurality of terminal portions (409A, 409B, 409N, 106A) includes a first terminal portion 409A electrically connected to a first electrical sensor device 404A, as shown in FIG. 3 . The second terminal portion 409B is electrically connected to another electrical sensor device (not shown). The Nth terminal portion 409N is electrically connected to an Nth electrical sensor device 404N, as shown in FIG. 3 . The core terminal portion 106A is electrically connected to the core element 106. At least some of the plurality of terminal portions (409A, 409B, 409N) are attached to (and extend axially along) an outer surface of the jacket element 108. At least some of the plurality of terminal portions (409A, 409B, 409N) extend in a radial direction (at least partially) along a flat radial end surface 911 (of the flexible medical guidewire assembly 102). The flat radial end surface 911 is positioned at an end portion (section) of the flexible medical guidewire assembly 102. At least some of the plurality of terminal portions (409A, 409B, 409N) are spaced (angularly spaced) apart from one another along the outer surface of the jacket element 108.

[0102] 12A, the core terminal portion 106A (preferably) extends axially from the end portion of the core element 106 from the end portion of the flexible medical guidewire assembly 102. The core terminal portion 106A (preferably) forms an elongated post (conductive post) having a keyed outer contour (such as a semicircular outer contour, etc.). The core terminal portion 106A (preferably) forms an outer end flat side that extends axially.

[0103] Referring to the embodiment shown in FIG. 12B, an electrical connector assembly 810 is configured to interface (electrically interface) with a plurality of terminal portions (409A, 409B, 409N, 106A) as shown in FIG. 12A. A push button 820 is attached to the electrical connector assembly 810 and configured to selectively electrically connect the internal electrical components of the electrical connector assembly 810 to the plurality of terminal portions (409A, 409B, 409N, 106A). The electrical connector assembly 810 forms (provides) a connector channel 824 (preferably a keyed connector channel). The connector channel 824 (keyed connector channel) is configured (formed or keyed) to receive a keyed (correspondingly keyed) terminal portion (preferably the proximal end) of the core terminal portion 106A or other flexible medical guidewire assembly 102 as shown in FIG. 12A. Leaf spring 836 is positioned on an inner surface (of electrical connector assembly 810) facing connector channel 824 (keyed connector channel). Leaf spring 836 is configured to bias the plurality of terminal portions (409A, 409B, 409N, 106A) of FIG. 12A toward a relatively secure electrical connection (and mechanical connection) between the plurality of terminal portions (409A, 409B, 106A) and corresponding electrical contacts provided by electrical connector assembly 810. Channel 824 (keyed connector channel) includes a keyed mating groove 838 (keyed slot) configured to (preferably) mate with (slidably receive) core terminal portion 106A of FIG. 12A. Electrical connector assembly 810 (with assistance from leaf spring 836) is configured to enable an axial sliding interface connection between the plurality of terminal portions (409A, 409B, 106A) and electrical connector assembly 810.

[0104] 12C, the electrical connector assembly 810 is configured to provide a keyed over-the-wire connection. This arrangement facilitates keyed alignment between the multiple terminal portions (409A, 409B, 409N, 106A) (also referred to as proximal electrode terminals) with spacing between the terminal portions. This arrangement reduces the risk of an incorrect electrical connection. The connector terminal 840 (of the electrical connector assembly 810) is positioned within the connector channel 824 (keyed connector channel) and is configured to electrically connect with the multiple terminal portions (409A, 409B, 409N, 106A) once the end portion of the flexible medical guidewire assembly 102 is inserted into the connector channel 824 of the electrical connector assembly 810.

[0105] (Addendum) As a preferred embodiment, the technical concept that can be grasped from the above embodiment will be described below.

[0106] [Item 1] 1. An apparatus comprising: a flexible medical guidewire assembly configured to be inserted into a confined space defined by a living body; a sensor assembly, the sensor assembly being securely supported by the flexible medical guidewire assembly such that once the flexible medical guidewire assembly is inserted into and moved along the enclosed space defined by the living body, the sensor assembly and the flexible medical guidewire assembly are movable along the enclosed space defined by the living body; the flexible medical guidewire assembly includes a core element that is electrically conductive; the flexible medical guidewire assembly also includes at least one electrical wire extending along a length of the flexible medical guidewire assembly, the at least one electrical wire having an outer diameter that varies along the longitudinal length of the flexible medical guidewire assembly; The device, wherein the sensor assembly is electrically connected to a proximal terminal portion of the flexible medical guidewire assembly via the at least one electrical wire, and the sensor assembly and the at least one electrical wire are electrically isolated from the core element.

[0107] [Item 2] Item 10. The device of item 1, wherein the sensor assembly and the at least one electrical wire are electrically isolated from the core element by an insulating layer disposed over the core element.

[0108] [Item 3] Item 10. The device of item 1, wherein the sensor assembly includes at least one electrode. [Item 4] a radio frequency emitter carried by the flexible medical guidewire assembly; Item 10. The device of item 1, wherein the radio frequency emitter is configured to ablate tissue.

[0109] [Item 5] the flexible medical guidewire assembly includes a distal portion; 5. The device of claim 4, wherein the radio frequency emitter is attached to the tip portion.

[0110] [Item 6] Item 6. The device of item 5, further comprising a sharp portion attached to the tip portion, the sharp portion configured to cut tissue.

[0111] [Item 7] The flexible medical guidewire assembly comprises: a jacket element surrounding the core element; Item 10. The device of item 1, wherein the core element and the jacket element extend along an elongate length of the flexible medical guidewire assembly.

[0112] [Item 8] 8. The apparatus of claim 7, wherein the flexible medical guidewire assembly comprises Society of Automotive Engineering Type stainless steel.

[0113] [Item 9] Item 10. The apparatus of item 1, wherein the core element includes an outer diameter that varies along the longitudinal length of the flexible medical guidewire assembly.

[0114] [Item 10] Item 10. The apparatus of item 1, wherein the core element comprises a hollow tube configured to receive and house an electrical wire.

[0115] [Item 11] the sensor assembly Item 1, comprising a magnetic sensor device or an electrical sensor device.

[0116] [Item 12] the sensor assembly Item 10. The apparatus of item 1, including an electrical sensor device configured to transmit an electrical signal.

[0117] [Item 13] Item 10. The device of item 1, wherein the at least one electrical wire terminates in a terminal contact positioned at a terminal end of the flexible medical guidewire assembly.

[0118] [Item 14] a sensor interface system configured to interface with the sensor assembly; the sensor interface system is also configured to exchange signals with the sensor assembly; a signal measurement system; Item 1 , wherein the sensor interface system is also configured to be electrically connectable to the signal measurement system.

[0119] [Item 15] the flexible medical guidewire assembly comprising a distal electrode; the distal electrode includes a radio frequency emitter, and once the flexible medical guidewire assembly is inserted into the enclosed space defined by the living body and once the distal electrode is activated, the radio frequency emitter is configured to provide an amount of energy that pierces tissue of the living body positioned adjacent to the distal electrode; the sensor assembly comprising a plurality of electrical sensor devices spaced apart from one another and fixedly positioned along a longitudinal length of the flexible medical guidewire assembly; a plurality of terminal portions positioned at a proximal end of the flexible medical guidewire assembly; the plurality of terminal portions are electrically coupled to respective ones of the plurality of electrical sensor devices; Item 1. The device of item 1, wherein the plurality of terminal portions are configured to be selectively electrically connectable to and removable from an electrical connector assembly. [Item 16] 1. An apparatus comprising: The device comprises a flexible medical guidewire assembly configured to be inserted into a confined space defined by a living body, the flexible medical guidewire assembly including an electrically conductive core element and at least one electrical wire extending along a length of the flexible medical guidewire assembly; the device includes a sensor assembly, the sensor assembly being securely supported by the flexible medical guidewire assembly such that when the flexible medical guidewire assembly is inserted into and moved along the enclosed space defined by the living body, the sensor assembly and the flexible medical guidewire assembly are movable along the enclosed space defined by the living body; The apparatus, wherein the core element includes an outer diameter that is smaller than an outer diameter of the at least one electrical wire. [Item 17] the sensor assembly is electrically connected to a proximal terminal portion of the flexible medical guidewire assembly via the at least one electrical wire; and Item 17. The apparatus of item 16, wherein the sensor assembly and the at least one electrical wire are electrically isolated from the core element. [Item 18] Item 17. The apparatus of item 16, wherein the sensor assembly includes a plurality of electrodes positioned under an outer diameter of a jacket element surrounding the core element. [Item 19] Item 17. The apparatus of item 16, wherein the flexible medical guidewire assembly is configured to guide insertion of a medical instrument into the enclosed space defined by the living body when the flexible medical guidewire assembly is inserted into the enclosed space defined by the living body. [Item 20] The flexible medical guidewire assembly comprises: Includes jacket elements, Item 17. The apparatus of item 16, wherein the jacket element is electrically insulating and surrounds the core element. [Item 21] tip portions are positioned at the ends of the end sections of the core element and the jacket element; the distal portion of the flexible medical guidewire assembly includes an electrode configured to deliver energy to a portion of tissue; 21. The device of claim 20, wherein the electrode is electrically connected to the core element to transmit the application of radio frequency energy from a generator to the electrode. [Item 22] the flexible medical guidewire assembly includes a proximal end, a distal end, and an electrode positioned near the distal end; the electrode is coupled to the core element extending from the proximal end, the core element configured to transfer energy to the electrode which emits the energy into tissue of a living body, and in response to the application of the energy, the electrode sharpens and pierces the tissue; the sensor assembly includes a plurality of proximal electrodes, the plurality of proximal electrodes being spaced apart from one another and fixedly positioned along a longitudinal length of the flexible medical guidewire assembly; a plurality of terminal portions positioned at the proximal end of the flexible medical guidewire assembly; the plurality of terminal portions are electrically coupled to the plurality of proximal electrodes, Item 21. The apparatus of item 20, wherein the plurality of terminal portions are configured to be selectively electrically connectable to an electrical connector assembly and to enable the electrical connector assembly to be removed from the plurality of terminal portions. [Item 23] tip portions are positioned at the ends of the end sections of the core element and the jacket element; the tip portion of the flexible medical guidewire assembly comprises a distal electrode; the distal electrode is electrically connected to the core element; 21. The device of claim 20, wherein the core element is electrically conductive. [Item 24] 24. The device of claim 23, wherein the proximal end of the core element is configured to be electrically connectable to a wire, the wire being configured to supply electricity to the distal electrode through the core element. [Item 25] the distal electrode comprises a radio frequency emitter; Item 24. The device of item 23, wherein the radio frequency emitter is configured to provide energy to tissue of the living body positioned adjacent to the distal electrode when the distal electrode is activated when the flexible medical guidewire assembly is inserted into the enclosed space defined by the living body. [Item 26] Item 17. The apparatus of item 16, wherein the sensor assembly comprises a plurality of electrical sensor devices, the plurality of electrical sensor devices being spaced apart from one another and fixedly positioned along the longitudinal length of the flexible medical guidewire assembly. [Item 27] The sensor assembly includes: an exposed portion of an electrical wire exposed on an outer surface of the flexible medical guidewire assembly; the electrical wire extends along the length of the flexible medical guidewire assembly; Item 17. The apparatus of item 16, wherein the electrical wires extend toward a terminal end of the flexible medical guidewire assembly and terminate in terminal contacts positioned at the terminal end of the flexible medical guidewire assembly. [Item 28] the flexible medical guidewire assembly comprises a distal electrode; the distal electrode comprises a radio frequency emitter configured to provide a piercing amount of energy to tissue of the living body positioned adjacent to the distal electrode; Item 17. The apparatus of item 16, wherein the sensor assembly comprises a plurality of electrical sensor devices, the plurality of electrical sensor devices being spaced apart from one another and positioned along a longitudinal length of the flexible medical guidewire assembly. [Item 29] the sensor assembly comprising a plurality of electrical sensor devices spaced apart from one another and fixedly positioned along a longitudinal length of the flexible medical guidewire assembly; a plurality of terminal portions positioned at a proximal end of the flexible medical guidewire assembly; the plurality of terminal portions are electrically coupled to respective ones of the plurality of electrical sensor devices; Item 17. The apparatus of item 16, wherein the plurality of terminal portions are configured to be selectively electrically connectable to and removable from an electrical connector assembly. [Item 30] Item 17. The apparatus of item 16, wherein the outer diameter of the core element increases toward the distal end of the flexible medical guidewire assembly.

[0120] The following is proposed as a further description of embodiments in which any one or more optional technical features (described in the Detailed Description, Abstract, and Claims) can be combined with any one or more optional technical features (described in the Detailed Description, Abstract, and Claims). Each claim in the Claims section is understood to be an open-ended claim unless otherwise specified. Unless otherwise specified, relative terms used in these specifications should be interpreted to include certain tolerances that a person skilled in the art would recognize to provide equivalent functionality. For example, the term "perpendicular" is not necessarily limited to 90.0 degrees, but may include variations thereof that a person skilled in the art would recognize to provide equivalent functionality for the described purpose of the associated member or element. Terms such as "about" and "substantially" in the context of a configuration generally relate to an exact or sufficiently close arrangement, placement, or configuration of associated elements to maintain operability of the elements within the invention without substantially altering the invention. Similarly, unless otherwise clear from the context, numerical values ​​should be interpreted to include certain tolerances that a person skilled in the art would recognize as negligible in importance because they do not substantially change the operability of the invention. It will be understood that the description and / or drawings identify and describe embodiments of the device (either explicitly or inherently). The device may include any suitable combination and / or permutation of the technical features identified in the detailed description, as may be needed and / or desired to suit a particular technical purpose and / or technical function. It will be understood that, where possible and preferred, any one or more technical features of the device may be combined (in any combination and / or permutation) with any other one or more technical features of the device. It will be understood that those skilled in the art will know that the technical features of each embodiment may be deployed in other embodiments, even if not explicitly set forth above. Those skilled in the art will understand that other options for the configuration of the device's components are possible, adjusting to manufacturing requirements and remaining within the scope set forth in at least one or more of the following claims. This specification provides embodiments, including the best mode, and will also enable those skilled in the art to make and use the embodiments.The patentable scope may be defined by the claims. The written description and / or drawings may be helpful in understanding the scope of the claims. All important aspects of the disclosed subject matter are believed to be provided herein. In this specification, the word "includes" is understood to be equivalent to the word "comprising," in that both words are used to indicate a non-limiting list of antecedents, components, parts, etc. The term "comprising," which is synonymous with the terms "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Comprising (comprised of) is an "open-ended" phrase, allowing for coverage of technologies that employ additional, unrecited elements. When used in a claim, the word "comprising" is a transitive verb (transitional term) that separates the antecedent of the claim from the technical features of the invention. The foregoing outlines non-limiting embodiments (examples). The description is made in terms of certain non-limiting embodiments (examples), it being understood that the non-limiting embodiments are merely illustrative by way of example. [Explanation of symbols]

[0121] Flexible medical guidewire assembly 102 Sensor Assembly 104 Core Elements 106 Core terminal part 106A Core insulation layer 106B Jacket element 108 Jacket Portal 108A First Jacket Channel 109A Second Jacket Channel 109B nth jacket channel 109N Tip part 110 Heating Devices 112 Heating Wire 113 Magnetic Sensor Device 402 Electrical Sensor Devices 404 First Electrical Sensor Device 404A nth electrical sensor device 404N Electric wire 405 First wire 405A Second wire 405B nth wire 405N Braided Elements 406 First Wire Insulation Layer 407A Second Wire Insulation Layer 407B nth wire insulation layer 407N Terminal part 409 First terminal part 409A Second terminal part 409B nth terminal part 409N Electrical Connector Assembly 810 Connector terminal 811 First connector terminal 811A Second connector terminal 811B Third connector terminal 811D nth connector terminal 811N Connector Wire 812 First connector wire 812A Second connector wire 812B 4th Connector Wire 812D nth connector wire 812N Handle 814 Housing Assembly 816 Spring material 818 Push Button 820 Conductor 822 Connector Channel 824 Complementary Contours 826 First Pole 828A Second Pole 828B Wire Connection 832 Spring material 833 Leaf spring 836 Mating slot 838 Connector terminal 840 Medical equipment 900 Living organism 902 Signal Measurement System 904 Sensor Interface System 906 Grounding element 908 Flat radial end face 911

Claims

1. It is a device, An electrical connector assembly having at least one connector terminal, The at least one connector terminal is selectively electrically connectable to at least one terminal portion of a flexible medical guidewire assembly and is detachable from the at least one terminal portion. The aforementioned flexible medical guidewire assembly is configured to be inserted into a closed space defined by a living organism. The at least one terminal portion is electrically connected via at least one wire to the sensor assembly supported by the flexible medical guidewire assembly. Device.

2. The aforementioned at least one connector terminal includes a plurality of connector terminals, The aforementioned at least one terminal portion includes a plurality of terminal portions, Each of the plurality of connector terminals is selectively electrically connectable to one of the corresponding terminal portions of the flexible medical guidewire assembly. The apparatus according to claim 1.

3. Further equipped with multiple connector wires, Each of the plurality of connector wires is electrically connected to one of the plurality of connector terminals, The electrical connector assembly can be selectively electrically connected to an external signal measurement system via the plurality of connector wires. The apparatus according to claim 2.

4. The at least one connector terminal includes a pair of jaws facing each other, The pair of jaws are configured to be spring-biased toward each other, The pair of jaws are configured to selectively grip the at least one terminal portion of the flexible medical guidewire assembly. The apparatus according to claim 1.

5. The electrical connector assembly includes a plurality of spaced-apart connector terminals, each having a pair of jaws, The electrical connector assembly is a side-loading, removable electrical connector that is selectively attachable laterally to the flexible medical guidewire assembly and is removable. The apparatus according to claim 4.

6. At least one of the plurality of connector terminals is keyed for keyed connection with a corresponding one of the plurality of terminal portions. The apparatus according to claim 5.

7. The electrical connector assembly further comprises a housing assembly and a handle extending from the housing assembly. The at least one connector terminal is supported by the housing assembly. The apparatus according to claim 1.

8. The electrical connector assembly defines a connector channel configured to receive at least partially axially the proximal end portion of the flexible medical guidewire assembly. The apparatus according to claim 1.

9. The aforementioned electrical connector assembly further comprises a push button and a connector conductor, The push button, when activated, is configured to selectively move the connector conductor to make electrical contact with at least one terminal portion of the flexible medical guidewire assembly received within the connector channel. The apparatus according to claim 8.

10. The electrical connector assembly further comprises a spring member disposed within it, The spring member is configured to bias the connector conductor toward the at least one terminal portion when the push button is activated. The apparatus according to claim 9.

11. The connector channel is a keyed connector channel configured to receive the keyed terminal portion of the flexible medical guidewire assembly. The apparatus according to claim 8.

12. The electrical connector assembly further comprises a leaf spring disposed on the inner surface of the electrical connector assembly facing the keyed connector channel, The leaf spring is configured to bias the at least one terminal portion toward electrical contact with the plurality of connector terminals when the proximal end portion of the flexible medical guidewire assembly is inserted into the keyed connector channel. The apparatus according to claim 11.

13. The electrical connector assembly further comprises a plurality of spring-loaded wire connectors extending axially within the connector channel, Each of the plurality of spring-loaded wire connectors comprises a spring member configured to bias the spring-loaded wire connector outward from the electrical connector assembly. Each of the plurality of spring-loaded wire connectors is configured to form electrical contact with a corresponding one of the plurality of terminals when the proximal end portion of the flexible medical guidewire assembly is inserted into the connector channel. The apparatus according to claim 8.

14. The sensor assembly comprises a plurality of electrical sensor devices arranged and fixed at intervals from one another along the longitudinal length of the flexible medical guidewire assembly. The at least one terminal portion includes a plurality of terminal portions located at the proximal end of the flexible medical guidewire assembly, Each of the plurality of terminal portions is electrically connected to a corresponding one of the plurality of electrical sensor devices via a corresponding one of a plurality of wires extending along the length of the flexible medical guidewire assembly. Each of the plurality of terminal portions is arranged at the proximal end portion of the flexible medical guidewire assembly, along the outer surface of the jacket element of the flexible medical guidewire assembly, with axial spacing between them. Each of the aforementioned terminal portions is exposed for selective electrical connection with the electrical connector assembly. The apparatus according to claim 1.

15. A sensor interface system configured to interface with the sensor assembly and exchange signals with the sensor assembly, wherein the sensor interface system is electrically connectable to the electrical connector assembly, and is configured to communicate electrically with the sensor assembly via the electrical connector assembly when at least one connector terminal of the electrical connector assembly is electrically connected to the at least one terminal portion, A signal measurement system electrically connectable to the aforementioned sensor interface system, wherein the signal measurement system is configured to receive signals from the sensor interface system, and the signals correspond to signals received from the sensor assembly. Furthermore, The sensor interface system is configured to adjust the signal received from the sensor assembly and to provide the adjusted signal to the signal measurement system. The apparatus according to claim 1.

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