Medical guidewire assembly and / or electrical connector

Abstract

To provide a flexible medical guide wire assembly configured to be inserted into a confined space defined by a living body.SOLUTION: A sensor assembly is securely supported by the flexible medical guidewire assembly. This is done in such a way that the sensor assembly and the flexible medical guidewire assembly are movable along the confined space defined by the living body once the flexible medical guidewire assembly is inserted into, and moved along, the confined 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 a flexible medical guidewire assembly. The terminal portion is electrically connected, via an electrical wire, to the sensor assembly of the flexible medical guidewire assembly.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] This document relates to (and is not limited to) the technical field of medical devices. (More specifically), this document relates to (and is not limited to) the technical field of medical guidewire assemblies (and / or methods therefor). (Even more specifically), this document relates to (but is not limited to) the technical field of electrical connectors for medical guidewire assemblies (and / or methods therefor).

Background Art

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

Summary of the Invention

[0003] It will be appreciated that there is a need to (at least partially) alleviate at least one problem associated with existing (known) medical devices (also referred to as the prior art). After much research and experimentation on existing (known) medical devices, an understanding (at least partially) of the problems and their solutions has been (at least partially) identified and (at least partially) clearly expressed as follows.

[0004] Cardiac catheterization procedures are medical procedures for the insertion of a catheter into a ventricle or blood vessel of the heart of a (patient). This can be done for diagnostic and / or interventional purposes. A common example of a cardiac catheterization procedure is a coronary artery catheterization procedure involving catheterization of the coronary arteries for the treatment of coronary artery disease and myocardial infarction (heart attack). The catheterization procedure can be performed in a special examination room equipped with fluoroscopy and a highly maneuverable table (the special examination room can be equipped with various sizes of catheters, stents, balloons, and other cabinets to improve the operating efficiency of the special examination room). Monitors can show (display) fluoroscopic imaging, electrocardiogram (ECG or EKG) data, images of pressure waves, and others.

[0005] Transseptal catheterization is a medical procedure used by interventional cardiologists to gain access to the left atrium of the heart (of a patient). This medical technique was first introduced for left-sided pressure measurement and has been integrated into various 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 such that inaccurate electrical signals cause abnormal heart rhythms. Diagnostic catheters are passed throughout the heart and are used to map the electrical signals of the blood vessels.

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

[0008] Transseptal catheterization may require several device exchanges between a known transseptal needle (and any equivalents thereof, also called scar devices) and a known guidewire. Known transseptal needles can be utilized to access the transseptal left heart for medical diagnosis 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 a bladder (among others) 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 uncertainty of X-ray exposure to the patient and / or physician and / or potentially dangerous exposure (it may be desirable to minimize X-ray exposure).

[0010] Problems with transseptal devices can be incompatible with non-fluoroscopic imaging modalities, specifically, they may not be optimized to maximize the utility of electroanatomical (EAM) mapping and / or other electrophysiology (EP) acquisition systems (and any equivalents thereof).

[0011] Fluoroscopy is an X-ray procedure that enables 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 can be valuable to visualize the tip of a medical device (such as a tissue puncture device, electrode, etc.) on a map (volume map or field of view inside the patient) generated by an electroanatomic mapping (EAM) system, which can also be performed while enhancing any imaging provided by an ultrasound system (such as using tools like intracardiac echocardiography (ICE)).

[0012] It can be valuable to obtain information regarding the spatial position of a medical device (such as a tissue puncture device, transseptal needle, etc.) attached to the distal position of a guidewire. Some physicians may understand that they may sometimes need to use fluoroscopy to ensure that the starter guidewire is safely tracked from the inferior vena cava (IVC), which leads into the heart, to the superior vena cava (SVC) of the 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] While optimized for use in a non-fluoroscopic imaging mode (e.g., for the exchange of a medical device on a known guidewire) associated with a medical procedure, it may be beneficial to provide a guidewire configured to function as a tissue puncture device.

[0014] The following are some of the identified problems: Known diagnostic catheters (e.g., including needles or puncture devices within a known catheter) may feature a hub that may not be usable for catheter exchange (medical device exchange), (B) may not have sufficient rigidity to be utilized in procedures such as transseptal puncture for cardiac cases, among other uses, and / or (C) are utilized for low-voltage applications (whereas a potential solution may be to use a relatively high-voltage delivery device in some cases, for example, to function as an electrosurgical device, among others).

[0015] It may 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 operation such as an electrophysiology study (EPS) as part of a medical therapy. It will be understood that the wire may be used to deliver a diagnostic catheter and sometimes the wire may be used to deliver a sheath that can ultimately guide the diagnostic catheter.

[0016] For subsequent signal analysis, it may be beneficial to provide a medical guidewire configured to sense signals (electrical signals, magnetic signals, etc.) input into a signal recording system. The signals (preferably, signals of relatively high precision) may be associated with an electrocardiogram (ECG) in any configuration such as a unipolar configuration or a bipolar configuration, among others.

[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 device may improve spatial resolution, simplify the workflow, and / or provide material savings. For example, after a ventricular catheter procedure is completed with a catheter treatment device attached to the tip of the medical guidewire, the medical guidewire can then be repositioned (or temporarily placed) in other areas of the heart to facilitate recording of signals (provided as sensor output signals from sensors attached to the medical guidewire) during treatment. Specific areas of the heart that may require signal recording (such as during an electrophysiology study) may include, among others, the right atrium (RA), right ventricle (RV), and / or coronary sinus (CS). Additionally, it may be beneficial to provide a medical guidewire configured to emit (transmit or send) signals in a predetermined manner such as a bipolar mode and / or a unipolar mode (preferably, additionally, the medical guidewire is configured to receive signals). Diagnostic electrophysiology (EP) catheters (also referred to as EP diagnostic catheters) can be used for temporary intracardiac sensing, recording, stimulation, and mapping. EP diagnostic catheters can be indicated for both recording and pacing (or as needed) of heart tissue. Additionally, known electroanatomical mapping (EAM) systems may require the emission of sensed signals from an emitter device (signal source), and the signals may need to be sensed by another device (signal receiving device) such as a receiver pad placed on the patient, among others.

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

[0019] At least in part, an apparatus is provided (in accordance with the main aspect) to mitigate at least one problem associated with existing technology. The apparatus includes, without limitation (comprising), 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 closed space defined by a living body. The sensor assembly is securely supported by the flexible medical guidewire assembly. This is done such that once the flexible medical guidewire assembly is inserted into and moved along a closed space defined by a living body, the sensor assembly and the flexible medical guidewire assembly are movable along the closed 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.

[0020] At least in part, a method is provided (in accordance with a main aspect) to mitigate at least one problem associated with existing technology. The method includes, but is not limited to (including), the operations of: (A) providing a flexible medical guidewire assembly configured to be inserted into a closed space defined by a living body; and (B) once the flexible medical guidewire assembly is inserted into and moved along a closed space defined by a living body, providing a sensor assembly securely supported by the flexible medical guidewire assembly such that the sensor assembly and the flexible medical guidewire assembly are movable along the closed space defined by the living body. It will be understood that a detailed description provides a description of embodiments of the flexible medical guidewire assembly. Preferably, a method for cases where a flexible medical guidewire assembly is utilized, the method including: (A) providing a flexible medical guidewire assembly configured to be inserted into a closed space defined by a living body, the providing including the presence of a sensor assembly securely supported by the flexible medical guidewire assembly; (B) at least in part, inserting the sensor assembly and the flexible medical guidewire assembly into the closed space defined by the living body; and (C) at least in part, once the flexible medical guidewire assembly is inserted into the closed space defined by the living body, moving the sensor assembly and the flexible medical guidewire assembly along the closed space defined by the living body.

[0021] At least in part, an apparatus (in accordance with the main aspect) is provided to mitigate at least one problem associated with existing technology. The apparatus includes, but is not limited to (comprises), an electrical connector assembly having connector terminals. The connector terminals are configured to be electrically connectable to 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 via an electrical wire to a sensor assembly of the flexible medical guidewire assembly. It will be appreciated that a detailed description provides a description of embodiments of the electrical connector assembly.

[0022] At least in part, a method (in accordance with the main aspect) is provided to mitigate at least one problem associated with existing technology. The method includes, but is not limited to (includes), providing an electrical connector assembly having connector terminals. The connector terminals are configured to be electrically connectable to a terminal portion 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 via an electrical wire to a sensor assembly of the flexible medical guidewire assembly. It will be appreciated that a detailed description provides a description of embodiments of the electrical connector assembly. Preferably, the method is a method of utilizing an electrical connector assembly, comprising: (A) providing an electrical connector assembly having connector terminals configured to be electrically connectable to a terminal portion of a flexible medical guidewire assembly, wherein the flexible medical guidewire assembly is configured to be inserted into a closed space defined by a living body and the terminal portion is electrically connected via an electrical wire to a sensor assembly of the flexible medical guidewire assembly; and (B) electrically connecting the connector terminals of the electrical connector assembly to the terminal portion of the flexible medical guidewire assembly.

[0023] At least in part, a method is provided (in accordance with a main aspect) to mitigate at least one problem associated with existing techniques. The method includes the following steps (operations), operation (A), operation (B), operation (C), and operation (D), without being limited to (including) these. Operation (A) includes using a medical imaging system (intracardiac echocardiography (ICE) system, electroanatomical mapping (EAM) system, etc., and any equivalents thereof) to generate (register, display, etc.) a medical image of a relevant anatomical structure of a patient (right atrium of the heart, septum separating the right and left atria of the heart, etc.). Operation (B) includes inserting (deploying, advancing, moving, etc.) a flexible medical guidewire assembly towards the relevant anatomical structure of the patient once the medical image has been generated by the medical imaging system, displayed to the physician performing the procedure, or thereafter (i.e., inserting the flexible medical guidewire assembly towards the relevant anatomical structure of the patient along a closed space defined by the living body). Operation (C) includes using the medical imaging system to detect the spatial position of a sensor assembly (fixedly attached to a part of the flexible medical guidewire assembly) while the flexible medical guidewire assembly is being inserted into the patient towards the relevant anatomical structure of the patient, such that the spatial position of a part of the flexible medical guidewire assembly (such as the tip) can be identified (detected) by the medical image processing system (i.e., the position of the part of the flexible medical guidewire assembly can be displayed to the physician while the flexible medical guidewire assembly is being inserted into the patient towards the relevant anatomical structure of the patient).The operation (D) includes guiding the insertion of a medical instrument along the length of the flexible medical guidewire assembly towards the relevant anatomical structure of the patient (i.e., once the physician determines that a portion of the flexible medical guidewire assembly has reached or is placed in proximity to the relevant anatomical structure of the patient and the flexible medical guidewire assembly is held so as not to move spatially relative to the relevant anatomical structure of the patient), such that the medical instrument is moved along a closed space defined by the living body towards the relevant anatomical structure of the patient. In this manner, the medical instrument can be actuated (or utilized) for the medical treatment of the relevant anatomical structure of the patient. It will be understood that other operations may include reversing the above-described operation steps for stopping and / or withdrawing the medical instrument from the patient, and withdrawing the flexible medical guidewire assembly from the patient. It will be understood that if the flexible medical guidewire assembly includes a heating device, and additional operation may include actuating the heating device (once the physician determines that a portion of the flexible medical guidewire assembly has reached or is placed in proximity to the relevant anatomical structure of the patient based on the generated medical image provided by the medical imaging system and the flexible medical guidewire assembly is held so as not to move spatially relative to the relevant anatomical structure of the patient). It will be understood that further operation steps may be added in view of the detailed description.

[0024] At least in part, a method is provided (in accordance with a main aspect) to mitigate at least one problem associated with existing technology. The method includes the following steps (operations), operation (A), operation (B), operation (C), and operation (D), without being limited to (including) these. Operation (A) includes using a medical imaging system (intracardiac echocardiography (ICE) system, electroanatomical mapping (EAM) system, etc., and any equivalents thereof) to generate (register, display, etc.) a medical image (volume map, shape capture system configured to capture tissue shape, etc., and any equivalents thereof) of a patient's relevant anatomical structure (right atrium of the heart, septum separating the right and left atria of the heart, etc.). Operation (B) includes inserting (deploying, advancing, moving, etc.) a flexible medical guidewire assembly towards the patient's relevant anatomical structure once the medical image has been generated by the medical imaging system and displayed to the physician performing the procedure, etc. (i.e., inserting the flexible medical guidewire assembly towards the patient's relevant anatomical structure along the restricted space defined by the living body). Operation (C) includes using 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 towards the patient's relevant anatomical structure so that the spatial position of a portion of the flexible medical guidewire assembly (such as the tip) can be identified (detected) by the medical image processing 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 towards the patient's relevant anatomical structure). Operation (D) includes activating a heating device (disposed in proximity to and fixedly positioned relative to a portion of the flexible medical guidewire assembly) once the physician determines that a portion of the flexible medical guidewire assembly has reached or is in proximity to the patient's relevant anatomical structure and the flexible medical guidewire assembly is held so as not to move spatially relative to the patient's relevant anatomical structure.It will be understood that the medical device for this method may or may not be deployed in conjunction with the deployment of the heating device, in that the deployment of the medical device is optional for this method. Other operations may include reversing the above-described operation steps for, among other things, stopping and / or canceling the medical device from the patient (if the medical device is utilized) and / or canceling the flexible medical guide wire assembly from the patient. It will be understood that additional operation 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 become apparent to those skilled in the art here when considering the following detailed description of the non-limiting embodiments with reference to the accompanying drawings. This summary is provided to introduce concepts in a simplified form that will be further described below in the detailed description. This summary is not intended to identify potential important features or possible essential features of the disclosed subject matter, nor is it intended to describe every embodiment of the disclosed subject matter 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 illustrate exemplary embodiments more specifically.

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

Brief Description of the Drawings

[0027]

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DETAILED DESCRIPTION OF THE INVENTION

[0028] The drawings are not necessarily to scale and may be shown in virtual lines, schematic views, and partial views. In certain instances, details that are not necessary for an understanding of the embodiments (and / or details that make it difficult to perceive other details) may be omitted. Corresponding reference numerals indicate corresponding components throughout several views of the drawings. Elements in the various figures are shown for simplicity and clarity and are not drawn to scale. Some dimensions of the elements in the figures may be emphasized relative to other elements to facilitate an understanding of the various disclosed embodiments. Additionally, commonly understood elements that are useful in commercially practicable embodiments are often not shown so as to provide an unobstructed view of the embodiments of the present disclosure.

[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 uses and applications of the described embodiments. As used, the words "exemplary" or "exemplification" mean "serving as an example, instance, or illustration." Any implementation described as "exemplary" or "exemplification" should not necessarily be construed as preferred or advantageous over other implementations. All of the implementations described below are exemplary implementations provided to enable those skilled in the art to make or use the embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. The scope of the claims is defined by the claims (the claims may be amended during patent examination after the filing of this application). For purposes of description, "upper," "lower," "left," "rear," "right," "front," "vertical," "horizontal," and their derivatives are related to the examples oriented in the drawings. No association is intended by any representation or implied theory in the foregoing technical field, background, summary, or the following detailed description. It should also be understood that the devices and processes shown in the accompanying drawings and described in the following specification are exemplary embodiments (examples), aspects, and / or concepts defined by the appended claims. Accordingly, dimensions and other physical characteristics related 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, permutations, embodiments, and any equivalents thereof) are described with respect to the drawings. It should be understood that the present invention is limited to the subject matter provided by the claims and is not limited to the specific aspects shown and described. It will be understood that the meaning of the scope of a device configured to be coupled to an article (i.e., connected to the article, interacting with the article, etc.) is construed as being configured such that the device is coupled to the article either directly or indirectly. Accordingly, "configured to" may include the meaning of "either directly or indirectly" unless otherwise specified.

[0030] FIG. 1A, FIG. 1B, FIG. 1C, and FIG. 1D show side perspective views of an embodiment of a flexible medical guidewire assembly 102. Referring to an embodiment as shown in FIG. 1A, an apparatus is shown that includes and is not limited to (including) 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 closed space defined by a living body 902. Embodiments of the living body 902 are shown in FIG. 2A or FIG. 2B. The living body 902 can include a human body, among others. The sensor assembly 104 is securely supported (configured to be supported thereby) 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 a closed space defined by the living body 902, the sensor assembly 104 and the flexible medical guidewire assembly 102 can move along the closed space defined by the living body 902. The flexible medical guidewire assembly 102 can include any type of flexible material. The sensor assembly 104 can include any type of sensor assembly.

[0031] Referring to an embodiment as shown in FIG. 1A, the flexible medical guidewire assembly 102 includes a sensor assembly 104 configured to respond to a stimulus (such as heat, light, sound, pressure, magnetism, or specific movements thereof, and any equivalents thereof, etc.) and transmit a resulting signal (such as an impulse for signal measurement or to operate a control function, among others). Preferably, the flexible medical guidewire assembly 102 is configured to include (support) the sensor assembly 104. The sensor assembly 104 can include a radiation emitter, an energy emitter, an energy receiver, a magnetic flux emitter, a rare earth magnet, among others, 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 selectively detachable from each other.

[0032] Referring to the embodiment as shown in FIG. 1A, the flexible medical guidewire assembly 102 is configured to guide the insertion of a medical instrument 900 (such as a catheter, others, and any equivalents thereof) into a closed space defined by a living body 902 (as shown in FIG. 2A or FIG. 2B), preferably once the flexible medical guidewire assembly 102 is inserted into the closed space defined by the living body 902. The flexible medical guidewire assembly 102 is preferably configured to facilitate catheter exchange (exchange of medical devices or removal and insertion of medical devices). The flexible medical guidewire assembly 102 preferably includes a relatively thin flexible wire (elongated flexible shaft) configured to be inserted into a closed or serpentine space (such as a closed space defined by a living body 902). The flexible medical guidewire assembly 102 preferably provides a guide for subsequent insertion of the medical instrument 900. The medical instrument 900 may include a relatively rigid and / or bulky medical device (medical instrument) such as a catheter (medical catheter), others. The medical device has a relatively rigid stiffness compared to the stiffness of the flexible medical guidewire assembly 102. The catheter provides (includes) a flexible tube (made of a medical material) configured to be inserted through a narrow opening into a body cavity space (such as a closed space defined by a living body 902), such as the bladder, to remove fluid therefrom. The catheter may be configured to be inserted into the body to treat a disease or perform a surgical procedure. By changing the material or adjusting the way the catheter is manufactured, it is possible to adjust the catheter for cardiovascular, urinary tract, gastrointestinal, neurovascular, and ophthalmic applications. The catheter may be configured to also enable drainage, administration of fluids or gases, access by surgical instruments, and performance of a wide variety of other tasks. The process of inserting the catheter is a catheter procedure. The catheter may include a thin flexible tube (soft catheter), and the catheter may be available with various levels of stiffness depending on the medical operation or application.When the catheter is too flexible, the flexible medical guidewire assembly 102 is first inserted into the (same) body cavity, and then, as the catheter is pushed into the body cavity, the flexible medical guidewire assembly 102 guides the catheter so that the catheter can be inserted into the body cavity.

[0033] Referring to the embodiment as shown in FIG. 1A, the flexible medical guidewire assembly 102 is configured for insertion into the closed space defined by the living body 902 in a manner that is (preferably) assisted only by the user (physician or technician), or only by any medical device previously inserted and positioned in the closed space defined by the living body 902 or others. The flexible medical guidewire assembly 102 is impermeable to the body fluid disposed in the closed space defined by the living body 902 (preferably once the flexible medical guidewire assembly 102 is inserted into the closed space defined by the living body 902). According to a preferred embodiment, the flexible medical guidewire assembly 102 has an outer diameter of (preferably) about 2 millimeters (mm) and an elongated length of about 30 inches to about 90 inches. It will be understood that other dimensions of the flexible medical guidewire assembly 102 are possible. According to an embodiment, the flexible medical guidewire assembly 102 has an elongated 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] Referring to the embodiment as shown in FIG. 1B, the flexible medical guidewire assembly 102 includes a synergistic combination of a (preferably) core element 106 and a jacket element 108 (also referred to as a jacket portion, envelope, outer coating, etc.) that surrounds the core element 106 (also called a mandrel). The core element 106 and the jacket element 108 extend along the elongated length of the flexible medical guidewire assembly 102. The flexible medical guidewire assembly 102 has a (preferably) circular cross-sectional section or profile (it will be understood that other profile shapes may be utilized).

[0035] Referring to the embodiment as shown in FIG. 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 as shown in FIG. 1B, the core element 106 preferably includes SAE (Society of Automotive Engineering) standard 304 stainless steel according to an option. SAE standard 304 stainless steel contains both chromium (15% - 20%) and nickel (2% - 10.5%) metals as main non-ferrous components. The core element 106 includes (according to another option) superelastic nitinol. Nitinol alloys exhibit two closely related unique properties, the shape memory effect (SME) and superelasticity (SE; also called 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, in which case heating is not required to recover the undeformed shape and the material exhibits a very large elasticity about 10 - 30 times that of ordinary metals.

[0037] Referring to the embodiment as shown in FIG. 1B, the core element 106 provides (preferably) 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 transmission line (electric wire).

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

[0039] Referring to the embodiment as shown in FIG. 1B, the core element 106 may include a hollow tube such as a hypodermic tube reinforcement member. The hypodermic tube is a long metal tube with microfabricated features along the length of the tube. According to an optional embodiment, the hollow tube is configured to receive and accommodate the electric wire 405. The hollow tube may provide a modular configuration, and the hollow tube may provide cutouts for controlling (adjusting) its other flexibility (rigidity).

[0040] Referring to the embodiment as shown in FIG. 1C, the flexible medical guidewire assembly 102 includes (preferably) a sensor assembly 104. The sensor assembly 104 includes (preferably) a magnetic sensor device 402. The magnetic sensor device 402 may include a rare earth magnet, a permanent magnet, and / or an electromagnet. The magnetic sensor device 402 includes a material configured to exhibit at least one property of magnetism, such as attracting other iron-containing objects or aligning itself within an external magnetic field.

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

[0042] Referring to the embodiment as shown in FIG. 1C, the flexible medical guide wire assembly 102 includes a wire 405 that extends (preferably) along the length of the flexible medical guide wire assembly 102. The wire 405 is electrically connected (coupled either directly or indirectly) to the sensor assembly 104. The wire 405 extends from the sensor assembly 104 towards the terminal end of the flexible medical guide wire assembly 102 (such as the proximal end of the flexible medical guide wire assembly 102) and terminates (at a terminal point or terminal contact) at the terminal end of the flexible medical guide wire assembly 102. The wire 405 may be referred to as a power transmission line. If the sensor assembly 104 includes a plurality of sensors, the plurality of wires 405 are deployed (once for each deployed or attached sensor assembly). The wire 405 may include a miniaturized wire (such as about 34 to about 44 AWG (American Wire Gauge)) to free up cross-sectional space disposed within the flexible medical guide wire assembly 102. The wire 405 may include copper, stainless steel, nitinol, or others. The wire 405 may include a flat ribbon wire having a rectangular cross-section with a thickness (e.g., about 0.002 inches or less), and preferably, can minimize the impact on the overall outer diameter of the wire and others. 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] Referring to the embodiment as shown in FIG. 1C, the flexible medical guide wire assembly 102 is adapted (preferably) to be free of the wire 405, and the sensor assembly 104 includes a wireless transmitter (known and not shown) configured to transmit a wireless signal. The wireless transmitter is positioned on the sensor assembly 104 (the wireless transmitter is an option for not using the wire 405). It will be understood that the wireless transmitter is equivalent to the wire 405.

[0044] Referring to the embodiment as shown in FIG. 1D, the flexible medical guidewire assembly 102 includes a synergistic combination of (preferably) a core element 106 and a jacket element 108. The core element 106 (also referred to as a mandrel) is electrically conductive. The jacket element 108 is electrically insulating and surrounds the core element 106.

[0045] Referring to the embodiment as shown in FIG. 1D, the tip portion 110 is positioned at the end portion of the core element 106 and the jacket element 108. The heating device 112 is attached to the tip portion 110 of the flexible medical guidewire assembly 102. The heating device 112 is electrically connected to the core element 106 (conductive in this embodiment). The heating wire 113 is electrically connectable (and disconnectable) to the proximal end (the end accessible to the user) 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 (emit) an amount of thermal energy sufficient to remove, cauterize, and / or puncture (preferably by the process of cauterization) tissue positioned adjacent to the (patient's) body (the tissue is positioned adjacent to (proximate to) the heating device 112 once the flexible medical guidewire assembly 102 is inserted into the closed space defined by the living body 902 and once the heating device 112 is activated accordingly). Cauterization includes the management (application and / or removal) of thermal energy in proximity to living tissue for the purpose of sealing blood vessels in the living tissue and preventing unwanted bleeding from the living tissue while forming voids, grooves, and / or passageways 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, a flexible medical guidewire assembly 102 is provided with at least one sensor assembly 104 combined with a radio frequency emitter (which is a tissue piercing device), the radio frequency emitter being configured to emit an amount of thermal energy sufficient to cauterize tissue (a tissue wall) positioned in proximity to the radio frequency emitter (thereby forming a hole or passage through the tissue or tissue wall), which provides a technical solution for using less fluoroscopy techniques and systems during a medical procedure and / or treatment (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 an electrical signal and / or is configured for electro-surgical purposes.

[0046] Referring to the embodiment as shown in FIG. 1D, the jacket element 108 may be referred to as an outer layer or an insulating layer (an electrical insulating material or an electrical insulating material). The jacket element 108 has, houses, or contains an electric wire 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 voids) configured to receive the electric wire 405 and others.

[0047] Referring to the embodiment as shown in FIG. 1D, the heating device 112 includes (preferably) 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 alloy (blend), or a mixture thereof. The electrode may form a hemispherical dome geometry having a (preferably) diameter (e.g., from about 0.015 inches to about 0.032 inches, more preferably a diameter of about 0.024 inches). The metal exposed (conductive) region preferably has a size of about 1.2 square millimeters (mm^2) to about 2.4 mm^2 to ensure a relatively high current density when about 270 Vrms (root mean square of volts squared) to about 400 Vrms is delivered in a monopolar mode (i.e., to a grounded patient) to achieve tissue puncture (RF puncture) of the tissue positioned adjacent to the patient once the flexible medical guidewire assembly 102 is inserted into the closed space defined by the living body 902 and once the heating device 112 is activated. 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 (for removing tissue) once RF energy is applied to the electrode and transmitted to the tissue.

[0048] Referring to the embodiments as shown in FIGS. 1A, 1B, 1C, and 1D, the following describes additional technical features for an embodiment of a flexible medical guidewire assembly 102. These are preferred embodiments and it will be understood that they are not essential for the flexible medical guidewire assembly 102. Preferably, the flexible medical guidewire assembly 102 is configured for medical device exchange (such as catheter exchange). Preferably, the working length of the flexible medical guidewire assembly 102 can be sufficient for medical device exchange (the guidewire length can be doubled 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, along most of the length of the flexible medical guidewire assembly 102, from about 0.001 Nm2 (Newtons per square meter pressure unit) to about 0.002 Nm2). Preferably, the flexible medical guidewire assembly 102 has a stiffness equivalent to that of a spring annealed stainless steel wire of gauge 304 (for example, with a diameter of about 0.018 inches) in the region of the flexible medical guidewire assembly 102 positioned across the atrial septum (of the heart). This preference can depend on many anatomical and environmental conditions, and it will be understood that some procedures benefit from high stiffness and some from low stiffness. Preferably, the flexible medical guidewire assembly 102 includes a core element 106 (also called a rigid core mandrel) with a jacket element 108 (also called a flexible jacket layer) placed or positioned over the core element 106 to improve shape retention of the flexible medical guidewire assembly 102 and / or to provide a smooth overall elongated profile. According to an embodiment, the core element 106 has an outer diameter range (for example, from about 0.015 inches to about 0.030 inches). According to an embodiment, the core element 106 includes stainless steel and / or nitinol.According to an embodiment, the jacket element 108 comprises a material that provides a minimal contribution to the stiffness of the flexible medical guidewire assembly 102. According to an embodiment, the jacket element 108 comprises an electrical insulating material (such as PTFE (polytetrafluoroethylene)). According to an embodiment, the jacket element 108 comprises a flexible steel coil. According to an embodiment, the jacket element 108 has a thickness such that the outer diameter of the flexible medical guidewire assembly 102 ranges from about 0.032 inches to about 0.035 inches.

[0049] According to an embodiment, 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 vessel. According to an embodiment, the flexible medical guidewire assembly 102 includes a radiation visible material. According to an embodiment, the flexible medical guidewire assembly 102 is configured to withstand handling (such as user force and / or environmental force, etc.) experienced during a medical (cardiac) procedure (treatment or diagnostic procedure). According to an embodiment, the flexible medical guidewire assembly 102 complies with international medical standards mandated for a minimum tensile force of about 10 N (Newtons), such as a medical guidewire sized in the range of about 0.032 inches to about 0.035 inches (preferably without loosening or separation of sections or parts of the flexible medical guidewire assembly 102). According to an embodiment, the electrical connection of the flexible medical guidewire assembly 102 (at the distal end) requires sufficient electrical insulation end-to-end to reduce interference (environmental interference). According to an embodiment, the flexible medical guidewire assembly 102 complies with international medical standards for an electrosurgical device that provides a minimum electrical insulation performance of the guidewire (for the protection of the patient and / or healthcare provider). According to an embodiment, the flexible medical guidewire assembly 102 includes a radio frequency (RF) device (also called a heating device) configured to deliver about 270 Vrms to 400 Vrms (volts root mean square) (preferably in a monopolar configuration) for distal tissue puncture or tissue removal. According to an embodiment, the flexible medical guidewire assembly 102 includes a jacket element 108, the jacket element 108 includes an insulating material having a thickness of about 0.00275 inches or more (such as PTFE), and the jacket element 108 is positioned over any voltage conducting conductor (core element 106, or other electrical wires, etc.) positioned within the flexible medical guidewire assembly 102 to meet the current leakage requirements. For example, the maximum dimension of the core element 106 can be about 0.029 inches so that the outer diameter of the flexible medical guidewire assembly 102 preferably remains less than about 0.035 inches.According to an embodiment, the jacket element 108 includes a relatively thick electrical insulation (to facilitate manufacturing). The thickness can be sized to vary the effective outer diameter of the flexible medical guide wire assembly 102. For example, if the core element 106 has a diameter of (preferably) about 0.018 inches and is made of a stainless steel material. The jacket element 108 includes a relatively thick PTFE layer to make the outer device diameter of the flexible medical guide wire assembly 102 (preferably) about 0.035 inches. According to an embodiment, the sensor device (medical sensor, electrode, etc.) is positioned on the flexible medical guide wire assembly 102. For example, the sensor device can be configured for low voltage electrical communication (such as for ECG recording), and a relatively thick insulation is not required and can be protected from the primary energy source and interference (preferably, end-to-end). According to an embodiment, the flexible medical guide wire assembly 102 can be biocompatible, maneuverable, and robust.

[0050] Figures 2A and 2B show front views of embodiments of the flexible medical guide wire assembly 102 of Figures 1A, 1B, 1C, and / or 1D. Referring to the embodiment as shown in FIG. 2A, a signal measurement system 904 (also referred to as a signal analysis system) is configured to be electrically connectable (optionally, electrically connectable, coupled) to a sensor interface system 906. The definition of "electrically connected" includes electrically magnetically connected, magnetically connected, acoustically connected, optically connected, and others. The signal measurement system 904 may include, for example, an electromagnetic system, an electroanatomical mapping system (3D (three-dimensional) or 2D (two-dimensional)), or an electroanatomical non-fluoroscopic mapping system, and others. The sensor assembly 104 includes a 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 causing the sensor interface system 906 to transmit a signal to the sensor assembly 104 and / or receive a signal from the sensor assembly 104. For the embodiment as shown in FIG. 2A, the sensor assembly 104 includes a magnetic device, and the sensor interface system 906 is configured to interact magnetically with the sensor assembly 104.

[0051] Referring to the embodiment as shown in FIG. 2B, the flexible medical guidewire assembly 102 includes an electric wire 405 (not shown in FIG. 2B but shown in the embodiment of FIG. 1C). The sensor assembly 104 includes (preferably) 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 electric wire 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 the signals received from the sensor assembly 104 and (then) provide the conditioned signals 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. Once connected (operatively connected) thereto, the electrical connector 810 is configured to be in electrical communication with the sensor assembly 104 (such as via the electric wire 405 as shown in FIG. 1C). The electrical connector 810 is also configured to be electrically connectable to the sensor interface system 906. Preferably, a ground element 908 (ground pad) is configured to be removably adhered to or in intimate removable contact with (preferably, the skin of) the living body 902. The ground element 908 is spaced apart from the sensor assembly 104. The ground element 908 is positioned proximate to the sensor assembly 104 (preferably, in the zone of interest for acquiring signals via the sensor assembly 104).Once sensor interface system 906 is electrically connected to wire 405 (via electrical connector 810) and ground element 908 is placed to mimic physical contact with living body 902, sensor interface system 906 is configured to communicate electrically with sensor assembly 104.

[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 the 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 (including) a heating device 112 (according to a preferred embodiment). The heating device 112 is configured to emit RF (radio frequency) energy from the flexible medical guidewire assembly 102 (for example, as shown in the embodiment of FIG. 2B) (from the distal end thereof) and into the tissue positioned adjacent to the living body 902. The core element 106 provides a relatively hard 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) that covers the core element 106. The jacket element 108 further includes an outer polymer layer that covers the jacket element 108 (preferably) (as required). For example, the jacket element 108 may include wiring, cables, and / or a plastic material having electrical insulation properties suitable for electrical shielding duty having sufficient performance characteristics (dielectric strength, thermal performance, insulation and corrosion, water, and heat resistance) for safety performance to comply with industrial and regulatory safety standards. For considerations in the selection of suitable materials, 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 [Netherlands]: Elsevier / William Andrew,

[2014] . The core element 106 terminates (and is electrically connected) within a heating device 112 (also referred to as a smooth dome-shaped electrode) positioned at the distal end of the flexible medical guidewire assembly 102. The heating device 112 is configured to puncture the tissue of the living body 902 (once actuated accordingly). The core element 106 further includes a core terminal portion 106A that extends 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 auxiliary instruments (known and not shown, such as RF generators and others). 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, among others) within a patient's tissue. The technical effect or technical advantage of the heating device 112 is that, for example, the heating device 112 can reduce the number of exchanges of medical devices (insertion and removal of the flexible medical guidewire assembly 102 in the closed space defined by the living body 902) as may be required for TSP (transseptal puncture) and cardiac catheter procedures (requiring the heating device 112). It can be of concern to both the patient (living body 902) and the physician in order to minimize the exchange of medical devices within the patient's body to reduce the risk of unwanted medical occurrences or situations such as air embolisms and others. For the preferred embodiment as shown in FIG. 3, the core element 106 is conductive and the heating device 112 is electrically connected to the core element 106.

[0054] Referring to the embodiment as shown in FIG. 3, the jacket element 108 is configured to electrically insulate (provide electrical insulation to) the core element 106. To provide electrical safety to the patient and the 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 radiofrequency (RF) tissue removal and / or tissue ablation, etc.), the core element 106 (or an equivalent alternative high-voltage wire line) may require a significant (sufficient) 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 can also be utilized as a heat-shrinkable material (form) to ensure conformal adhesion to the core element 106 (electrically energized mandrel) that efficiently uses the available space in the flexible medical guidewire assembly 102 (i.e., reduces the space consumed by the gap between the wire extending internally along the longitudinal length of the flexible medical guidewire assembly 102 and the hollow elongated extrusion void or lumen). The flexible medical guidewire assembly 102 may have an outer diameter of about 0.035 inches and may require effective insulation with a wall thickness of about 0.003 inches of PTFE material to meet the current (ampere) leakage requirements of electrosurgical medical standards. Preferably, the maximum inner diameter of the core element 106 is about 0.029 inches (in accordance with what can be tolerated 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 as shown in FIG. 3, the sensor assembly 104 (such as an electrical sensor, etc.) includes a first electrical sensor device 404A (also referred to as a proximal electrode) and an Nth electrical sensor device 404N (where N is any integer such as 1, 2, 3, etc.). The first electrical sensor device 404A and the Nth electrical sensor device 404N are spaced apart from each other and fixedly positioned along the longitudinal length of the flexible medical guide wire assembly 102 (each of the electrical sensor devices is spaced apart from each other). According to a preferred option, the first electrical sensor device 404A and the Nth electrical sensor device 404N are (preferably) placed on the outer surface of the jacket element 108. The first electric wire 405A is electrically connected to the first electrical sensor device 404A (etc.). The first electric wire 405A is embedded within the flexible medical guide wire assembly 102. The first electric wire 405A extends along the length of the flexible medical guide wire assembly 102 from the first electrical sensor device 404A to the proximal end (terminal end) of the flexible medical guide wire assembly 102, and the same applies to other electric wires. The Nth electric wire 405N (the Nth electric wire) is electrically connected to the Nth electrical sensor device 404N. The Nth electric wire 405N (the Nth electric wire) extends along the length of the flexible medical guide wire assembly 102 from the Nth electrical sensor device 404N to the proximal end (terminal end) of the flexible medical guide wire assembly 102. The Nth electric wire 405N is embedded within the flexible medical guide wire assembly 102. The jacket element 108 (electrical insulation layer) covers and electrically insulates the first electric wire 405A and the Nth electric wire 405N. The first electric wire 405A and the Nth electric wire 405N are aligned parallel to the core element 106. The first electric wire 405A and the Nth electric 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 insulated from each other (to avoid electrical and / or magnetic interference between these devices).For considerations in the selection of 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 [Netherlands]: Elsevier / William Andrew,

[2014] .

[0056] Referring to the embodiment as shown in FIG. 3, the core terminal portion 106A (proximal electrical connection) is disposed at the terminal end of the core element 106. The core terminal portion 106A is exposed for electrical connection to the measurement system (via electrical wiring) as shown in the embodiment of FIG. 2B. Preferably, the core terminal portion 106A extends (so as to extend axially) from the end section of the 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 conform across the outer surface of the jacket element 108.

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

[0059] Referring to the embodiment as shown in FIG. 3, the sensor assembly 104 (electrical sensor device) may include at least one exposed portion of the wire 405, such as a portion of the wire (405A, 405N) exposed on (or positioned on) the outer surface of the flexible medical guidewire assembly 102. The exposed portion of the wire 405 is exposed without the jacket element 108 being positioned over the exposed portion of the wire 405. In this way, the exposure of the wire 405 to tissue (e.g., the patient's blood flow) can provide an electrical communication and signal sensing function for utilizing other medical instruments (electrocardiogram machines, etc.). For the case where the wire 405 persists inside and along the length of the flexible medical guidewire assembly 102, it will be understood that a window through which the wire 405 functioning as the sensor assembly 104 (electrode, etc.) can be exposed is formed through the jacket element 108. In this way, the sensor assembly 104 may include the exposed portion of the wire 405 (i.e., the wire 405 is exposed outside the jacket element 108).

[0060] Referring to the embodiment as shown in FIG. 3, the sensor assembly 104 includes an exposed portion of the wire 405 exposed on the outer surface of the flexible medical guidewire assembly 102 (according to one embodiment). The wire 405 extends along the length of the flexible medical guidewire assembly 102. The wire 405 extends towards the terminal end of the flexible medical guidewire assembly 102. The wire 405 terminates (is electrically connected) at a terminal contact positioned or disposed at the 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 the embodiments as shown in FIGS. 1A, 1B, and 1C where applicable).

[0062] Referring to the embodiment as shown in FIG. 4, the first electrical sensor device 404A and the Nth electrical sensor device 404N are counterbores that are under (positioned under) the outer diameter (outer surface) of the jacket element 108. The technical effect of this arrangement is to enable relatively easy sliding movement of the flexible medical guide wire assembly 102 along the closed space defined by the living body 902 (as shown in the embodiments of FIGS. 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 via wires (405A, 405N) through spatially separated windows (voids) formed in the outermost layer (upper) of the jacket element 108 (for electrical recording, among other things, by an external medical instrument).

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

[0064] Referring to the embodiment as shown in FIG. 5, the flexible medical guide wire assembly 102 further includes (and is not limited to) a braiding element 406. The braiding element 406 is positioned inside the body of the flexible medical guide wire assembly 102. The braiding element 406 may include a metal alloy. The braiding element 406 is elastically flexible (elastically deformable). The braiding element 406 includes a braided wire having strands of wire braided together. The braiding element 406 is positioned under the outer surface of the flexible medical guide wire assembly 102. The braiding element 406 is spaced from (and surrounds) the core element 106. The braiding element 406 is configured to improve the rigidity and / or torqueability of the flexible medical guide wire assembly 102. For example, if it is necessary to minimize the diameter of the flexible medical guide wire assembly 102 (and thus the rigidity of the core element 106), the braiding element 406 may recover some of the rigidity of the flexible medical guide wire assembly 102.

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

[0066] Referring to the embodiments as shown in Figures 6A and 6B, the stiffness of the flexible medical guide wire assembly 102 is provided (preferably) by wires such as a combination of wires (the first wire 405A, the second wire 405B, and the Nth wire 405N), and not by the core element 106 (or, the core element 106 is not provided as an alternative). That is, the first wire 405A, the second wire 405B, and the Nth wire 405N are relatively large in size (to add more stiffness to the flexible medical guide wire assembly 102), and the core element 106 may or may not be included in the flexible medical guide wire assembly 102. When the core element 106 is included (deployed), the core element 106 may have its diameter reduced to improve manufacturability and positioning of the first electrical sensor device 404A (proximal electrode) and the Nth electrical sensor device 404N (proximal electrode), among others. The core insulation layer 106B is positioned over the core element 106. The jacket portal 108A (void) is formed within the central zone of the jacket element 108 such that the core element 106, the first wire 405A, the second wire 405B, and the Nth wire 405N are all positioned within the jacket portal 108A. The technical effect of this embodiment is that once the flexible medical guide wire assembly 102 is curved, the wires can bend and flex without electrically disconnecting, short-circuiting, or otherwise malfunctioning.

[0067] According to the embodiments 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 includes an elongated wire (a relatively thin wire for lower voltage capabilities) that extends along the longitudinal length of the flexible medical guidewire assembly 102. The core element 106 includes a relatively low surface area and / or diameter, and this arrangement provides additional room for other components because it is 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 wire 405A can be increased to provide increased mechanical rigidity for the flexible medical guidewire assembly 102. To balance the stiffness profile of the flexible medical guidewire assembly 102 (to provide a relatively elastic distal portion, a relatively rigid proximal body portion, etc.), the profile (outer diameter) of the core element 106 and / or the wire 405 can vary along the longitudinal length of the flexible medical guidewire assembly 102. For example, relatively long instances of the core element 106 can include a reduction in outer diameter and cross-sectional area along their length to provide the desired flexibility (local flexibility) for a selected portion of the flexible medical guidewire assembly 102. For example, the outer diameter of the core element 106 can increase towards the distal tip (of the flexible medical guidewire assembly 102) to improve fixation and rigidity at the most distally positioned medical device (such as a medical sensor device).

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

[0069] Referring to the embodiment as shown in FIG. 7A, the first wire insulation layer 407A is placed on the first wire 405A and, for each wire. The second wire insulation layer 407B is placed across the second wire 405B. The Nth wire insulation layer 407N is placed across 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 arranged coaxially along the length (longitudinal axis) of the flexible medical guide wire assembly 102 within the jacket portal 108A. According to an embodiment, the core element 106, the first wire 405A, the second wire 405B, and the Nth wire 405N are (preferably) electrically insulated from each other (and from the patient, others). According to another embodiment, the first wire 405A, the second wire 405B, and the Nth wire 405N are (preferably) (for the case where the core element 106 is not conductive) electrically insulated from each other and from the patient. The flexible medical guide wire 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 annealed stainless steel). The electrical insulation layer (such as the core insulation layer 106B as shown in FIG. 6B, also called primary insulation) is positioned on the core element 106 and preferably has a thickness of about 0.003 inches. The wires (405A, 405B, 405N, etc.) can have any suitable cross-section or profile, such as a circular cross-section or a rectangular cross-section. The wires (405A, 405B, 405N, etc.) can have a thickness dimension (diameter contribution) of about 0.002 inches. The wire insulation layer placed across each of the wires (405A, 405B, 405N, etc.) can 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 enable a sensor device (also referred to as a ring electrode as shown in FIG. 6A) to be placed. According to an embodiment, the sensor device (proximal electrode) can be placed (positioned) in a relatively elastic section of the flexible medical guidewire assembly 102 where the outer diameter of the core element 106 is reduced to improve its elasticity. The elastic region (of the flexible medical guidewire assembly 102) can include a stainless steel material (elongated mandrel) in the range of 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 the sensor device (proximal electrode) and other connectors.

[0071] Referring to the embodiment as shown in FIG. 7B, the core insulation layer 106B is positioned across the core element 106. The jacket portal 108A is disposed between the outer surface of the core insulation layer 106B and the inner surface of the jacket element 108. The first wire 405A, the second wire 405B, and the Nth 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 polyhedral geometry (having a multi-angled cross-section with wires positioned at the vertices of, for example, a polyhedral geometry such as a triangle).

[0072] Referring to the embodiment as shown in FIG. 7C, the core insulation layer 106B defines recesses configured to receive the respective wires (405A, 405B, 405N) therein. The outer shape of the core insulation layer 106B has a circular or circular cross-sectional shape. The inner surface 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 wires (405A, 405B, 405N), each having its respective electrical insulation layer thereon (as shown in the embodiment of FIG. 7A).

[0074] Referring to the embodiment as shown in FIG. 7E, the jacket element 108 defines (provides) jacket channels (the first jacket channel 109A, the second jacket channel 109B, and the Nth jacket channel 109N). Each of the wires (405A, 405B, 405N) is received in its 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 embodiments shown in FIGS. 7A - 7E, an increase in relative movement (and / or slack therefor) between the wires (405A, 405B, 405N) can provide additional flexibility for the flexible medical guide wire assembly 102. The core element 106 (which can be conductive and is also called a mandrel) is configured to provide most of the mechanical rigidity (with respect to the jacket element 108 and the wires (405A, 405B, 405N)). The jacket element 108 (also called a coating) is configured to provide sufficient electrical insulation to withstand a relatively high voltage and / or current for the core element 106. The wires (405A, 405B, 405N) are electrically insulated (electrically isolated) from each other and from the core element 106. The wires (405A, 405B, 405N) can be configured to handle relatively low voltages or relatively high voltages, among others. The jacket element 108 can be flexible and can be lubricious (smooth and slippery with an oil or similar substance).

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

[0077] Referring to the embodiment as shown in FIG. 8A, the jacket element 108 defines (forms) a jacket portal 108A (having a circular cross-sectional contour). The core insulating layer 106B is disposed across the core element 106, each having a semi-circular cross-sectional contour. The core element 106 forms an offset (non-circular) shape. The core element 106 and the core insulating 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 for receiving electrical wires (405A, 405B, 405N). Each of the electrical wires (405A, 405B, 405N) has an electrical insulating layer (such as a first wire insulating layer 407A, etc.). The core element 106 forms a shape configured to provide additional space to improve the manufacturability and scalability of the electrical wires (405A, 405B, 405N).

[0078] Referring to the embodiment as shown in FIG. 8B, the core insulating layer 106B forms voids configured to receive the electrical wires (405A, 405B, 405N). The core insulating layer 106B forms two voids (cavities), one cavity for receiving the core element 106 and the other cavity for receiving the electrical wires (405A, 405B, 405N).

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

[0080] Referring to the embodiment as shown in FIG. 9A, the core terminal portion 106A extends (extends axially) from an end portion (proximal portion 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 needs to be conductive).

[0081] Referring to the embodiments as shown in FIGS. 9B and 9C, the electrical connector 810 is configured to be selectively electrically connected (clipped) to the core terminal portion 106A. The electrical connector 810 may include a clip connector, an alligator clip, and the like, and any equivalents thereof. The electrical connector assembly 810 includes connector terminals 811 (electrical connector contacts, jaw portions, and the like), such as a pair of opposing jaws (usually spring-biased to be closed, and the like). According to an embodiment, the electrical connector assembly 810 is configured to connect to an electrical terminal (terminal portion 409, electrical connection) positioned at the proximal end of the flexible medical guidewire assembly 102. The electrical terminal is attached to a portion (such as a distal portion) of the flexible medical guidewire assembly 102 and is electrically connected to, for example, an electrical sensor device 404A and / or a medical device (such as a heating device 112) as shown in FIG. 3 and the like. The electrical connector assembly 810 is also configured to connect an electrical terminal of an external device (known and not shown, a signal generator or a signal recording system, and the like) to an electrical terminal (at least one or more cases of the terminal portion 409) of the flexible medical guidewire assembly 102. This is preferably done such that the nominal diameter of the flexible medical guidewire assembly 102 can be maintained (for example, about 0.032 inches to about 0.035 inches, and the like). Preferably, the electrical connector assembly 810 provides a conductive pin configured to enable (facilitate) an electrical connection to the electrical terminal (terminal portion 409) of the flexible medical guidewire assembly 102 in a single user operation (for convenience). Alternatively, the electrical connector assembly 810 is configured to provide a conductive pin configured to enable (facilitate) an electrical connection between the electrical terminal of the flexible medical guidewire assembly 102 and a plurality of selective independent connections, and the like.

[0082] Referring to the embodiment as shown in FIG. 9D, the core terminal portion 106A extends axially from the end portion of the core element 106. The core terminal portion 106A is exposed for electrical connection (when the 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 the respective electrical sensor device (404A, 404N) shown in any one of the embodiments of FIGS. 3, 4, and / or 5. For example, the first terminal portion 409A (wire terminal, proximal connection) is electrically coupled to the first electrical sensor device 404A (via the first 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 visualized considering the first electrical sensor device 404A) via the second wire 405B. The Nth terminal portion 409N (proximal connection) is electrically coupled to the Nth electrical sensor device 404N (via the Nth wire 405N). The terminal portions (409A, 409B, 409N) are spaced apart from each other along the length of the jacket element 108 (axially spaced apart) and are positioned on the outer surface of the jacket element 108 proximate to the end portion of the flexible medical guide wire assembly 102 (near the location of the core terminal portion 106A). According to a preferred embodiment, the flexible medical guide wire assembly 102 is configured to facilitate catheter exchange by having a proximal end (user access end portion) without a handle such that the catheter can pass through the length (overall length) of the flexible medical guide wire assembly 102. When the handle is positioned at the proximal end, the catheter may then not be able to pass through the length of the flexible medical guide wire assembly 102. According to a preferred embodiment, the flexible medical guide wire assembly 102 includes a plurality of instances of the sensor assembly 104 such that the sensor assembly 104 is connectable to a measurement device (as shown in FIGS. 2A or 2B).

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

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

[0085] Referring to the embodiments as shown in FIGS. 9E and 9F, the electrical connector assembly 810 has connector terminals 811 (such as a first connector terminal 811A, a second connector terminal 811B, and an Nth connector terminal 811N, etc.). The connector terminals 811 are configured to be electrically connectable to at least one terminal portion 409 of the flexible medical guide wire assembly 102. The flexible medical guide wire assembly 102 is configured to be inserted into a closed space defined by a living body 902 (as previously described and as shown in FIGS. 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 via an electric wire 405 (as shown in the embodiment of FIG. 3, for example). The terminal portion 409 is positioned at the proximal end of the flexible medical guide wire assembly 102. The terminal portion 409 is exposed for selective electrical connection to the electrical connector assembly 810. The sensor assembly 104 and the electric wire 405 are supported by the flexible medical guide wire assembly 102 (this is done so that once the flexible medical guide wire assembly 102 is inserted into and moved along the closed space defined by the living body 902, the sensor assembly 104 and the flexible medical guide wire assembly 102 can move along the closed space defined by the living body 902).

[0086] Referring to the embodiments as shown in FIGS. 9E and 9F, the connector terminals 811 (of the electrical connector assembly 810) include connector terminals (811A, 811B, 811N, 811D) for respective terminal portions (409A, 409B, 409N, 106A). The core terminal portion 106A can be utilized or deployed as an electric wire when a heater device or other medical device is deployed in or with the flexible medical guide wire assembly 102. For example, the connector terminals (811A, 811B, 811N, 811D) preferably include a first pair of jaws for electrical connection with the first terminal portion 409A, a second pair of jaws for electrical connection with the second terminal portion 409B, an Nth pair of jaws for electrical connection with the Nth terminal portion 409N, and a pair of core jaws for electrical connection with the core terminal portion 106A. The connector wires (812A, 812B, 812D, 812N) (connector electric wires) are each electrically connected to a connector terminal (811A, 811B, 811N, 811D). 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 (for connection to the core terminal portion 106A).

[0087] Referring to the embodiments as shown in FIGS. 9E and 9F, the electrical connector assembly 810 includes a side-loading removable electrical connector. The electrical connector assembly 810 includes, for example, and supports a plurality of spaced-apart alligator clips attached to (or extending from) the electrical connector assembly 810.

[0088] Referring to the embodiment as shown in FIG. 9F, the electrical connector assembly 810 includes an asymmetric hairpin style connector having a hard stop and a variable gap formed in the alligator jaws to reduce misconnection and ensure proper electrical connection to the electrical sensor devices (404A, 404N). The connector terminal 811A is keyed for keyed connection to the first terminal portion 409A. The third connector terminal 811D (such as a joe) is keyed for keyed connection to the core terminal portion 106A. When the core terminal portion 106A is not deployed as a wire, the third connector terminal 811D is otherwise unused.

[0089] Referring to the embodiment as shown in FIG. 9F, the electrical connector assembly 810 includes a handle 814 extending from the housing assembly 816. The first connector terminal 811 is supported by the housing assembly 816. The connector wire 812 is supported by the housing assembly 816.

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

[0091] Referring to the embodiment as shown in FIG. 10A, the electrical connector assembly 810 is configured to electrically interface (interact) with the end portion (proximal end portion) of the flexible medical guide wire assembly 102. The electrical connector assembly 810 is configured to be backloaded (back-connected) to the flexible medical guide wire 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 guide wire assembly 102. The electrical connector assembly 810 includes a push button 820 positioned on the surface (such as the upper surface) of the electrical connector assembly 810. The electrical connector assembly 810 includes connector conductors 822 (electrodes, etc.). The push button 820 is actuated by a user (such as a physician) to (A) selectively move the connector conductors 822 and (B) selectively connect the connector conductors 822 to the terminal portion (such as the core terminal portion 106A) of the flexible medical guide wire assembly 102 once the end portion of the flexible medical guide wire assembly 102 is received in the connector channel 824 and once the push button 820 is actuated accordingly.

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

[0093] Referring to the embodiment as shown in FIG. 10B, the upper case of the electrical connector assembly 810 is shown in the loading position (i.e., the electrical connector assembly 810 is ready to receive the end portion of the flexible medical guide wire assembly 102). The lower case of the electrical connector assembly 810 is shown in the locked and engaged position (the electrical components of the electrical connector assembly 810 are in electrical contact with the terminals of the flexible medical guide wire 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 guide wire assembly 102. The push button 820 is configured to move the upper electrical terminals 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) (in a vertical column). The first pole 828A and the second pole 828B are spaced apart from each other.

[0094] According to the embodiments shown in FIGS. 10A and 10B, each unique electrical connection can be provided by independent movement to ensure a (fully) 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 made contact.

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

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

[0097] Referring to the embodiment as shown in FIG. 11B, the end portion (proximal portion) of the flexible medical guide wire assembly 102 includes a flat radial end face 911 (rear plane, end face, etc.) facing along the axial axis extending from the end portion of the flexible medical guide wire assembly 102. The first terminal portion 409A includes a first flattened end face terminal portion extending radially (at least partially) along the flat radial end face 911. The second terminal portion 409B includes a second flattened end face terminal portion extending radially (at least partially) along the flat radial end face 911. The Nth terminal portion 409N includes an Nth flattened end face terminal portion extending radially (at least partially) along the flat radial face 911.

[0098] Referring to the embodiment as 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 as shown in FIGS. 11A and / or 11B. The terminal portions (409A, 409B, 409N) are positioned on the flat radial end face 911 as shown in FIGS. 11A and / or 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 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] Referring to the embodiment as shown in FIG. 11C, the push button 820 is attached to the outside of the housing of the electrical connector assembly 810. The push button 820 is configured to selectively lock (and selectively unlock) to the end portion (proximal end) of the flexible medical guide wire assembly 102. In some embodiments, it will be understood that the flexible medical guide wire assembly 102 includes a core terminal portion 106A where the core element 106 is also conductive, among other things, conductive. Once the push button 820 is actuated (by a user or a physician, etc.), the push button 820 selectively locks (securely connects) the electrical connector 810 to the end portion of the flexible medical guide wire assembly 102, and the radially extending wire connection 832 makes electrical contact with the terminal portions (409A, 409B, 409N, 106A), etc. The spring member 818 (also called a compression spring) is positioned in the electrical connector 810 and is configured to bias the connector conductor 822 to the core terminal portion 106A (across the axial axis of the flexible medical guide wire assembly 102) once the end portion of the flexible medical guide wire assembly 102 is inserted into the connector channel 824 of the electrical connector 810.

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

[0101] Referring to the embodiment as shown in FIG. 12A, the flexible medical guide wire assembly 102 includes a plurality of terminal portions (409A, 409B, 409N, 106A) (preferably) positioned at the terminal end portion (proximal end portion or user accessible portion) of the flexible medical guide wire 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 the 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 the outer surface of the jacket element 108 (and extend axially along a portion thereof). At least some of the plurality of terminal portions (409A, 409B, 409N) extend (at least partially) in a radial direction along the flat radial end face 911 (of the flexible medical guide wire assembly 102). The flat radial end face 911 is positioned at the end portion (section) of the flexible medical guide wire assembly 102. At least some of the plurality of terminal portions (409A, 409B, 409N) are spaced apart (angularly) from each other along the outer surface of the jacket element 108.

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

[0103] Referring to the embodiment as shown in FIG. 12B, the 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. The push button 820 is attached to the electrical connector assembly 810 and is 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 the core terminal portion 106A as shown in FIG. 12A and the keyed (corresponding keyed) terminal portion (preferably the proximal end) of the other flexible medical guide wire assembly 102. The leaf spring 836 is positioned on the inner surface (of the electrical connector assembly 810) facing the connector channel 824 (keyed connector channel). The 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 the corresponding electrical contacts provided by the electrical connector assembly 810. The channel 824 (keyed connector channel) includes a keyed mating groove 838 (keyed slot) configured to mate (slidably receive) the core terminal portion 106A of FIG. 12A. The electrical connector assembly 810 (with the assistance from the leaf spring 836) is configured to enable an axial sliding interface connection between the plurality of terminal portions (409A, 409B, 106A) and the electrical connector assembly 810.

[0104] Referring to the embodiment as shown in FIG. 12C, the electrical connector assembly 810 is configured to provide a keyed over-the-wire connection. This arrangement provides (facilitates) a keyed alignment among a plurality of terminal portions (409A, 409B, 409N, 106A) (also referred to as proximal electrode terminals) with an interval therebetween, reducing the risk of incorrect electrical connection. The connector terminals 840 (of the electrical connector assembly 810) are disposed inside a connector channel 824 (keyed connector channel), and are configured to electrically connect with the plurality of terminal portions (409A, 409B, 409N, 106A) once an end portion of the flexible medical guide wire assembly 102 is inserted into the connector channel 824 of the electrical connector assembly 810.

[0105] (Appendix) As a preferred embodiment, the technical idea grasped from the above embodiment is described below.

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

[0108] [Item 3] The device according to item 1, wherein the sensor assembly includes at least one electrode. [Item 4] The device further comprising a radio frequency emitter supported by the flexible medical guide wire assembly, The device according to item 1, wherein the radio frequency emitter is configured to cauterize tissue.

[0109] [Item 5] The flexible medical guide wire assembly includes a tip portion, The device according to item 4, wherein the radio frequency emitter is attached to the tip portion.

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

[0111] [Item 7] The flexible medical guide wire assembly, includes a jacket element surrounding the core element, The device according to item 1, wherein the core element and the jacket element extend along an elongated length of the flexible medical guide wire assembly.

[0112] [Item 8] The flexible medical guide wire assembly of claim 7, comprising Society of Automotive Engineering Type stainless steel.

[0113] [Item 9] The device of claim 1, wherein the core element comprises an outer diameter that varies along the longitudinal length of the flexible medical guide wire assembly.

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

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

[0116] [Item 12] The sensor assembly of claim 1, comprising an electrical sensor device configured to transmit an electrical signal.

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

[0118] [Item 14] The device of claim 1, further comprising a sensor interface system configured to interface with the sensor assembly, wherein the sensor interface system is also configured to exchange signals with the sensor assembly, further comprising a signal measurement system, wherein the sensor interface system is also configured to be electrically connectable to the signal measurement system.

[0119] [Item 15] The flexible medical guide wire assembly includes a distal electrode, the distal electrode includes a radio frequency emitter, and once the flexible medical guide wire assembly is inserted into the closed 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 punctures the tissue of the living body positioned adjacent to the distal electrode, the sensor assembly includes a plurality of electrical sensor devices that are spaced apart from each other and fixedly positioned along the longitudinal length of the flexible medical guide wire assembly, a plurality of terminal portions are positioned as the proximal end of the flexible medical guide wire assembly, the plurality of terminal portions are electrically coupled to each one of the plurality of electrical sensor devices, The apparatus according to item 1, wherein the plurality of terminal portions are configured to be selectively electrically connectable to an electrical connector assembly and removable from the electrical connector assembly.

[0120] The following is proposed as a further description of embodiments in which any one or more arbitrary technical features (described in the detailed description, summary, and claims) can be combined with any one or more other arbitrary technical features (described in the detailed description, summary, and claims). Each claim in the paragraphs of the claims is to be understood as a non-limiting claim unless otherwise specified. Unless otherwise specified, the relational terms used in these specifications should be construed to include certain tolerances that those skilled in the art will recognize as providing equivalent functionality. By way of example, the term "vertical" is not necessarily limited to 90.0 degrees and may include its variations that those skilled in the art will recognize as providing equivalent functionality for the purposes described for the associated member or element. Terms such as "about" and "substantially" in the context of a configuration generally relate to an arrangement, deployment, or configuration that is exactly or sufficiently close to maintain the operability of the elements within the present invention without substantially changing the present invention. Similarly, unless otherwise clear from the context, numerical values should be construed to include certain tolerances recognized as being negligible by those skilled in the art so as not to substantially change the operability of the present invention. It will be understood that the description and / or drawings identify and describe embodiments of the apparatus (either explicitly or inherently). The apparatus may include any suitable combination and / or permutation of the technical features identified in the detailed description as necessary and / or desired to suit a particular technical purpose and / or technical function. It will be understood that, where possible and suitable, any one or more technical features of the apparatus may be combined with any one or more other technical features of the apparatus (in any combination and / or permutation). It will be understood that those skilled in the art will know that, even if not explicitly stated as above, in other embodiments, the technical features of each embodiment may be developed. It will be understood that those skilled in the art will know that other options are possible for the configuration of the components of the apparatus, adapting to manufacturing requirements and remaining within the scope described in at least one or more of the claims. This specification provides embodiments including the best mode and enables those skilled in the art to make and use the embodiments.The scope of patentability can be defined by the claims. The written description and / or drawings can be helpful in understanding the scope of the claims. It is believed that all important aspects of the disclosed subject matter are provided herein. In this specification, the word "includes" is understood to be equivalent to the term "comprising" in that both words are used to indicate a preamble, components, parts, and other non-limiting lists. The term "comprising", which is synonymous with the terms "including", "containing", or "characterized by", is inclusive or non-limiting and does not exclude additional, unrecited elements or method steps. Comprising (comprised of) is a "non-limiting" phrase and enables the scope of application of technologies that adopt additional, unrecited elements. When used in a claim, the word "comprising" is a transitional verb that separates the preamble of the claim from the technical features of the invention. The foregoing outlines non-limiting embodiments (examples). The description is made with respect to specific non-limiting embodiments (examples). It is understood that the non-limiting embodiments are merely illustrative as examples.

Explanation of Reference Signs

[0121] Flexible medical guidewire assembly 102 Sensor assembly 104 Core element 106 Core terminal portion 106A Core insulating layer 106B Jacket element 108 Jacket portal 108A First jacket channel 109A Second jacket channel 109B nth jacket channel 109N Tip portion 110 Heating device 112 Heating wire 113 Magnetic sensor device 402 Electric sensor device 404 First electric sensor device 404A Nth electric sensor device 404N Electric wire 405 First electric wire 405A Second electric wire 405B Nth electric wire 405N Braided element 406 First wire insulation layer 407A Second wire insulation layer 407B Nth wire insulation layer 407N Terminal portion 409 First terminal portion 409A Second terminal portion 409B Nth terminal portion 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 Fourth connector wire 812D Nth connector wire 812N Handle 814 Housing assembly 816 Spring member 818 Push button 820 Conductor 822 Connector channel 824 Complementary contour 826 First pole 828A Second pole 828B Wire connection 832 Spring member 833 Leaf spring 836 Fitting slot 838 Connector terminal 840 Medical device 900 Living body 902 Signal measurement system 904 Sensor interface system 906 Grounding element 908 Flat radial end face 911

Claims

[Claim 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 apparatus, 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.

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