Medical guidewire assembly and / or electrical connector

Abstract

This invention discloses a flexible medical guidewire assembly configured for insertion into a confined space defined by a living body. A sensor assembly is securely supported by the flexible medical guidewire assembly. This is accomplished in such a way that once the flexible medical guidewire assembly is inserted into and moves within the confined space defined by the living body, both the sensor assembly and the flexible medical guidewire assembly are movable within the confined space. An electrical connector assembly with connector terminals is also disclosed. These connector terminals are configured to electrically connect to a terminal portion of the flexible medical guidewire assembly. This terminal portion is electrically connected via wires to the sensor assembly of the flexible medical guidewire assembly.

Description

Technical Field

[0001] This document relates to (but is not limited to) the technical field of medical devices; and (more specifically) to (but is not limited to) the technical field of medical guidewire assemblies (and / or methods thereof); and (even more specifically) to (but is not limited to) the technical field of electrical connectors for medical guidewire assemblies (and / or methods thereof). Background Technology

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

[0003] It should be understood that there is a need to mitigate (at least partially) at least one problem associated with existing (known) medical devices (also known as prior art). Following extensive research and experimentation with existing (known) medical devices, the understanding of the problems and their solutions has been (at least partially) determined and clarified (at least partially) as follows:

[0004] Cardiac catheterization is a medical procedure used to insert a catheter into a patient's heart chamber or blood vessel. This can be used for diagnostic and / or interventional purposes. A common example of cardiac catheterization is coronary artery catheterization, which involves inserting a catheter into a coronary artery to treat coronary artery disease and myocardial infarction (heart attack). Catheterization can be performed in a specialized laboratory equipped with fluoroscopy and a highly maneuverable workbench (where the specialized laboratory may be equipped with cabinets containing catheters, stents, balloons, etc. of various sizes to improve operational efficiency). Monitors can display fluoroscopic imaging, electrocardiogram (ECG or EKG) data, pressure wave images, etc.

[0005] Transseptal catheterization is a medical procedure used by interventional cardiologists to access the left atrium of the heart. Originally used for left-sided pressure measurement, this technique has now been integrated into various procedures, including left atrial ablation and percutaneous mitral valve repair.

[0006] Cardiac ablation is a medical procedure used to scar or destroy tissue in the heart, allowing erroneous electrical signals to cause abnormal heart rhythms. A diagnostic catheter is inserted through a blood vessel to reach the heart, where it is used to map the heart's electrical signals.

[0007] Transseptal puncture (TSP) is a medical procedure used in childhood and adulthood to access the left atrium for catheter ablation, left ventricular hemodynamic assessment, left ventricular assist device implantation, percutaneous left atrial appendage occlusion, or mitral valve repair.

[0008] Transseptal catheterization procedures may require multiple device changes between a known transseptal needle (and any equivalent) (also known as a scar-forming device) and a known guidewire. Known transseptal needles can be used to access the left ventricle via the transseptum for medical diagnostics and / or interventional procedures, etc.

[0009] A catheter is a flexible medical tube configured to be inserted through a narrow opening into a (patient's) body cavity, such as the bladder, to remove fluid. Initially, a known guidewire is inserted into the patient, and then the catheter is advanced along and guided by the known guidewire (once the catheter is positioned, the guidewire can be removed from the patient). Each device change and repositioning of the catheter involves uncertainty and / or potential risk of X-ray radiation exposure to the patient and / or physician (it may be desirable to minimize X-ray radiation exposure).

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

[0011] Fluorescence microscopy is an X-ray procedure that allows visualization of the movement of internal organs. Fluorescence microscopy uses X-rays (which are radioactive) to produce real-time video images. To reduce and / or eliminate the need for fluorescence microscopy, it may be valuable to visualize the ends of medical devices (such as tissue biopsy devices, electrodes, etc.) onto maps (volume maps or views of the patient's interior) generated by an electroanatomical mapping (EAM) system; this can be done concurrently with any imaging provided by an ultrasound system (using tools such as ICE (intracardiac echocardiography)).

[0012] Obtaining information about the spatial location of medical devices (such as tissue puncture devices, transseptal needles, etc.) inserted distal to the guidewire can be valuable; it should be understood that some physicians may sometimes need to use fluorescein microscopy to ensure that the initiator guidewire has been safely traced from the inferior vena cava (IVC) leading to the heart to the superior vena cava (SVC) (of the patient's heart). Additionally, after removal of the transseptal needle, it may be necessary to confirm the guidewire's path on the left side of the heart (due to the uncertainties associated with the guidewire's distal location).

[0013] It may be valuable to provide guidewires configured to function as tissue puncture devices while being optimized for non-fluorescent fluoroscopic imaging modalities for replacement steps associated with medical procedures (e.g., for replacing medical devices on known guidewires). Some identified problems include: known diagnostic catheters (including, for example, needles or puncture devices within known catheters) may (A) have hubs that may not be usable for catheter replacement (medical device replacement); (B) lack sufficient rigidity, for example, in procedures such as transseptal puncture for cardiac cases; and / or (C) be used for low-voltage applications (however, in some cases, a potential solution could be to use relatively high-voltage delivery devices to function as, for example, electrosurgical devices).

[0014] Providing flexible medical guidewires configured for use in minimally invasive medical procedures can be beneficial; physicians may need to deploy additional diagnostic catheters (on the medical guidewire) to perform desired medical tasks, such as electrophysiological studies (EPS) as part of a medical therapy. It should be understood that guidewires can sometimes be used to deliver diagnostic catheters, and sometimes guidewires can be used to deliver sheaths that can ultimately guide the diagnostic catheter.

[0015] Providing a medical guidewire configured to sense signals (such as electrical or magnetic signals) to be input into a signal recording system for subsequent signal analysis can be beneficial. The signal (preferably a relatively high-precision signal) can be correlated with an electrocardiogram (ECG) in any configuration (such as a unipolar or bipolar configuration).

[0016] Providing a medical guidewire with at least one or more sensor devices (such as multiple electrodes) supported by the medical guidewire may be advantageous. Sensor devices can improve spatial resolution, streamline workflows, and / or provide material savings. For example, after catheter insertion into the ventricle is completed using a catheter insertion device attached to the end of the medical guidewire, the medical guidewire can then be repositioned (or parked) in other areas of the heart to facilitate signal recording during treatment (provided as sensor output signals from sensors attached to the medical guidewire). Specific areas of the heart that may require signal recording (e.g., during electrophysiological studies) may include the right atrium (RA), right ventricle (RV), and / or coronary sinus (CS), etc. Providing a medical guidewire (preferably an additional medical guidewire configured to receive signals) configured to emit (transmit or transmit) signals in a predetermined manner, such as bipolar and / or unipolar. Diagnostic electrophysiology (EP) catheters (also known as EP diagnostic catheters) can be used for temporary intracardiac sensing, recording, stimulation, and mapping. EP diagnostic catheters can be indicated for use in recording and pacing of cardiac tissue (as needed or when required). In addition, known electroanatomical mapping (EAM) systems may require the transmission of sensing signals from a transmitter device (signal source) and may require the sensing of signals by another device (signal receiver device), such as a receiver pad placed on the patient.

[0017] Utilizing at least one implementation scheme may be beneficial in research and development projects and / or medical clinical settings.

[0018] Providing a medical guidewire that adds at least one medical function that can be performed by multiple separate medical devices may be beneficial.

[0019] To at least partially mitigate at least one problem associated with the prior art, an apparatus is provided (according to a major aspect). The apparatus includes, but is not limited to, a synergistic combination of a flexible medical guidewire assembly and a sensor assembly. The flexible medical guidewire assembly is configured for insertion into a confined space defined by a living body. The sensor assembly is securely supported by the flexible medical guidewire assembly. This is accomplished in such a way that once the flexible medical guidewire assembly is inserted into and moved along the confined space defined by the living body, the sensor assembly and the flexible medical guidewire assembly are movable along the confined space defined by the living body. It should be understood that the detailed description provides a description of embodiments of the flexible medical guidewire assembly.

[0020] To at least partially mitigate at least one problem associated with the prior art, a method is provided (according to a major aspect). The method includes, but is not limited to, the following steps (operations): operation (A), which provides the flexible medical guidewire assembly configured for insertion into a confined space defined by a living body; and operation (B), which provides a sensor assembly securely supported by the flexible medical guidewire assembly such that once the flexible medical guidewire assembly is inserted into and moves along the confined space defined by the living body, the sensor assembly and the flexible medical guidewire assembly are movable along the confined space defined by the living body. It should be understood that the detailed description provides a description of embodiments of the flexible medical guidewire assembly. Preferably, the method is used to utilize a flexible medical guidewire assembly, comprising: (A) providing a flexible medical guidewire assembly configured to be inserted into a confined space defined by a living body, wherein a sensor assembly is present and is securely supported by the flexible medical guidewire assembly; and (B) inserting the sensor assembly and the flexible medical guidewire assembly at least partially into the confined space defined by the living body; and (C) once the flexible medical guidewire assembly is inserted into the confined space defined by the living body, moving the sensor assembly and the flexible medical guidewire assembly at least partially along the confined space defined by the living body.

[0021] To at least partially mitigate at least one problem associated with the prior art, an apparatus is provided (according to a major aspect). The apparatus includes, but is not limited to, an electrical connector assembly having connector terminals. The connector terminals are configured to be electrically connected to a terminal portion (wire terminal) of a flexible medical guidewire assembly. The flexible medical guidewire assembly is configured to be inserted into a confined space defined by a living body. The terminal portion is electrically connected via wire to a sensor assembly of the flexible medical guidewire assembly. It should be understood that the detailed description provides a description of embodiments of the electrical connector assembly.

[0022] To at least partially mitigate at least one problem associated with the prior art, a method is provided (according to a major aspect). This method includes, but is not limited to, providing an electrical connector assembly having connector terminals. The connector terminals are configured to be electrically connected to a terminal portion of a flexible medical guidewire assembly. The flexible medical guidewire assembly is configured to be inserted into a confined space defined by a living body. The terminal portion is electrically connected via wires to a sensor assembly of the flexible medical guidewire assembly. It should be understood that the detailed description provides a description of embodiments of the electrical connector assembly. Preferably, the method is used to utilize the electrical connector assembly, comprising: (A) providing an electrical connector assembly having connector terminals configured to be electrically connected to a terminal portion of a flexible medical guidewire assembly, wherein the flexible medical guidewire assembly is configured to be inserted into a confined space defined by a living body, and wherein the terminal portion is electrically connected via wires 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] To at least partially mitigate at least one problem associated with the prior art, a method is provided (according to a major aspect). This method includes, but is not limited to, the following steps (operations): operation (A), operation (B), operation (C), and operation (D). Operation (A) includes generating (recording, displaying, etc.) medical images (such as voltograms, geometry capture systems configured to capture tissue geometry, etc., of relevant anatomical structures of the patient, such as the right atrium, the septum separating the right and left atria, etc.) using a medical imaging system (such as intracardiac echocardiography (ICE) systems, electroanatomical mapping (EAM) systems, etc.). Operation (B) includes inserting (deploying, advancing, moving, etc.) a flexible medical guidewire assembly toward the relevant anatomical structures of the patient (i.e., inserting the flexible medical guidewire assembly along a confined space defined by the living body and toward the relevant anatomical structures of the patient) while or after the medical images are generated by the medical imaging system and displayed to a physician performing the procedure. Operation (C) involves using a medical imaging system to detect the spatial position of a sensor assembly (fixed to a portion of the flexible medical guidewire assembly) when the flexible medical guidewire assembly is inserted toward the relevant anatomy of the patient, such that the spatial position of a portion (e.g., the tip) of the flexible medical guidewire assembly can be identified (detected) by the medical imaging system (i.e., the position of a portion of the flexible medical guidewire assembly can be displayed to the physician when the flexible medical guidewire assembly is inserted toward the relevant anatomy of the patient). Operation (D) involves guiding (once the physician determines that a portion of the flexible medical guidewire assembly has reached or been placed near the relevant anatomy of the patient, and that the flexible medical guidewire assembly remains spatially stationary relative to the relevant anatomy of the patient), inserting a medical device (along the length of the flexible medical guidewire assembly) into the relevant anatomy of the patient (i.e., the medical device moves toward the relevant anatomy of the patient along a confined space defined by the living body because the flexible medical guidewire assembly has reached a position near the relevant anatomy of the patient), and in this way, the medical device can be aroused (or utilized) to treat the relevant anatomy of the patient. It should be understood that other operations may include reversing the above-described steps to deactivate and / or retrieve the medical device from the patient, and retrieving the flexible medical guidewire assembly from the patient, etc. It should be understood that, in cases where the flexible medical guidewire assembly includes a heating device, additional operations may include activating the heating device (once the physician has determined (based on medical images generated by a medical imaging system) that a portion of the flexible medical guidewire assembly has reached or been placed near the relevant anatomical structures of the patient, and that the flexible medical guidewire assembly remains spatially stationary relative to the relevant anatomy of the patient). It should be understood that, given the detailed description, additional operational steps may be added.

[0024] To at least partially mitigate at least one problem associated with the prior art, a method is provided (according to a major aspect). This method includes, but is not limited to, the following steps (operations): operation (A), operation (B), operation (C), and operation (D). Operation (A) includes generating (recording, displaying, etc.) medical images (e.g., volumetric maps, geometric capture systems configured to capture tissue geometry, etc.) of relevant anatomical structures of the patient (e.g., the right atrium, the septum separating the right and left atria, etc.) using a medical imaging system (e.g., intracardiac echocardiography (ICE) system, electroanatomical mapping (EAM) system, etc., and any equivalent thereof). Operation (B) includes inserting (deploying, advancing, moving, etc.) a flexible medical guidewire assembly toward the relevant anatomical structures of the patient (i.e., inserting the flexible medical guidewire assembly along a confined space defined by the living body and toward the relevant anatomical structures of the patient) when or after the medical images are generated by the medical imaging system and displayed to a physician performing the procedure, etc. Operation (C) involves using a medical imaging system to detect the spatial position of a sensor assembly (fixedly mounted to a portion of the flexible medical guidewire assembly) when the flexible medical guidewire assembly is inserted into the patient toward the relevant anatomical structure, such that the spatial position of a portion (e.g., the tip) of the flexible medical guidewire assembly can be identified (detected) by the medical imaging system (i.e., the position of a portion of the flexible medical guidewire assembly can be displayed to the physician when the flexible medical guidewire assembly is inserted into the patient toward the relevant anatomical structure). Operation (D) involves activating a heating device (located and fixedly positioned near the portion of the flexible medical guidewire assembly) once the physician has determined that a portion of the flexible medical guidewire assembly has reached or been placed near the relevant anatomical structure of the patient and that the flexible medical guidewire assembly remains spatially stationary relative to the relevant anatomical structure of the patient. It should be understood that, for this method, the medical device may or may not be deployed with the heating device, as the deployment of the medical device is optional for this method. It should be understood that other operations may include reversing the above-described steps to deactivate and / or retract the medical device from the patient (if the medical device is used) and / or retract the flexible medical guidewire assembly from the patient, etc. It should be understood that, given the detailed description, additional operational steps may be added.

[0025] Other aspects are identified in the claims. Other aspects and features of the non-limiting embodiments will now become apparent to those skilled in the art after reading the following detailed description of the non-limiting embodiments with accompanying drawings. This summary is provided to introduce concepts in a simplified form that will be further described in the following detailed description. This summary is not intended to identify potential key features or possible essential features of the disclosed subject matter, nor is it intended to describe every disclosed embodiment or every implementation of the disclosed subject matter. Many other novel advantages, features, and relationships will become apparent as this description proceeds. The following drawings and description illustrate exemplary embodiments in more detail. Attached Figure Description

[0026] When taken in conjunction with the accompanying drawings, the non-limiting embodiments can be more fully understood by referring to the following detailed description of the non-limiting embodiments, wherein:

[0027] Figure 1A , Figure 1B , Figure 1C and Figure 1D A side perspective view depicting an embodiment of the flexible medical guidewire assembly is shown; and

[0028] Figure 2A and Figure 2B Depicting Figure 1A , Figure 1B , Figure 1C and / or Figure 1D A front view of an embodiment of a flexible medical guidewire assembly; and

[0029] Figure 3 Depicting Figure 1D A front perspective view of an implementation scheme for a flexible medical guidewire assembly;

[0030] Figure 4 Depicting Figure 1D A front perspective view of an embodiment of a flexible medical guidewire assembly; and

[0031] Figure 5 Depicting Figure 1D A front perspective view of an embodiment of a flexible medical guidewire assembly; and

[0032] Figure 6A and Figure 6B Depicting Figure 1D Axial cross-sectional view of the implementation scheme of the flexible medical guidewire assembly ( Figure 6A ) and radial section diagram ( Figure 6B );and

[0033] Figure 7A , Figure 7B , Figure 7C , Figure 7D and Figure 7E Depicting Figure 1D A radial cross-sectional view of an embodiment of a flexible medical guidewire assembly; and

[0034] Figure 8A and Figure 8B Depicting Figure 1D A radial cross-sectional view of an embodiment of a flexible medical guidewire assembly; and

[0035] Figure 9A Depicting Figure 1D A side view of an embodiment of a flexible medical guidewire assembly; and

[0036] Figure 9B , Figure 9C , Figure 9D , Figure 9E and Figure 9F Depicting configurations that can be connected to Figure 9A A side view of an embodiment of the electrical connector for a flexible medical guidewire assembly; and

[0037] Figure 10A and Figure 10B Depicting configurations that can be connected to Figure 1D A side view of an embodiment of the electrical connector for a flexible medical guidewire assembly; and

[0038] Figure 11A and Figure 11B Depicting Figure 1D A perspective view of an implementation scheme for a flexible medical guidewire assembly; and

[0039] Figure 11C Depicting configurations that can be connected to Figure 11A and / or Figure 11B A side view of an embodiment of the electrical connector for a flexible medical guidewire assembly; and

[0040] Figure 12A Depicting Figure 1D A perspective view of an implementation scheme for a flexible medical guidewire assembly; and

[0041] Figure 12B and Figure 12C Depicting configurations that can be connected to Figure 12A A side view of an embodiment of an electrical connector for a flexible medical guidewire assembly.

[0042] The accompanying drawings are not necessarily drawn to scale and may be shown using dashed lines, diagrams, and partial views. In some cases, details that are unnecessary for understanding the embodiments (and / or details that make other details difficult to understand) may be omitted. Throughout the various figures, corresponding reference numerals indicate corresponding parts. Elements in the figures are shown for simplicity and clarity and are not necessarily drawn to scale. The dimensions of some elements in the figures may be emphasized relative to other elements to facilitate understanding of the various disclosed embodiments. Additionally, common and well-known elements that are useful in commercially viable embodiments are not typically depicted to provide a less obstructive view of the embodiments of this disclosure.

[0043] List of icon numbers used in the attached figures

[0044] Flexible medical guidewire assembly 102

[0045] Sensor assembly 104

[0046] Core component 106

[0047] 106A chip terminal section

[0048] Core insulation layer 106B

[0049] Sheath component 108

[0050] Sheath Inlet 108A

[0051] First sheath channel 109A

[0052] Second sheath channel 109B

[0053] Nth sheath channel 109N

[0054] End portion 110

[0055] Heating device 112

[0056] Heating wire 113

[0057] Magnetic sensor device 402

[0058] Electrical sensor device 404

[0059] First electrical sensor device 404A

[0060] Nth electrical sensor device 404N

[0061] 405 wire

[0062] First Wire 405A

[0063] Second wire 405B

[0064] Nth wire 405N

[0065] Braided element 406

[0066] First wire insulation layer 407A

[0067] Second wire insulation layer 407B

[0068] The insulation layer of the Nth wire is 407N.

[0069] Terminal section 409

[0070] First terminal section 409A

[0071] Second terminal section 409B

[0072] Nth terminal section 409N

[0073] Electrical connector assembly 810

[0074] Connector terminal 811

[0075] First connector terminal 811A

[0076] Second connector terminal 811B

[0077] Third connector terminal 811D

[0078] Nth connector terminal 811N

[0079] Connector 812

[0080] First connecting line 812A

[0081] Second connecting wire 812B

[0082] Fourth connecting cable 812D

[0083] Nth connection line 812N

[0084] 814 Handle

[0085] Housing assembly 816

[0086] Spring component 818

[0087] Button 820

[0088] Conductor 822

[0089] Connector Channel 824

[0090] Complementary contours 826

[0091] First pole 828A

[0092] Second pole 828B

[0093] Wire connection 832

[0094] Spring component 833

[0095] Leaf spring 836

[0096] Matching slot 838

[0097] Connector terminal 840

[0098] Medical Devices 900

[0099] Live 902

[0100] Signal Measurement System 904

[0101] Sensor Interface System 906

[0102] Grounding element 908

[0103] Flat radial end face 911 Detailed Implementation

[0104] The following detailed description is merely exemplary and is not intended to limit the described embodiments or their application and use. As used, the terms “exemplary” or “illustrative” mean “serving as an example, illustration, or description.” Any implementation described as “exemplary” or “illustrative” is not necessarily to be construed as being more preferred or advantageous than other implementations. All implementations described below are exemplary embodiments provided to enable those skilled in the art to make or use the embodiments of this disclosure and are not intended to limit the scope of this disclosure. The scope of the claims is defined by the claims (wherein the claims may be amended during the patent examination process after the filing of this application). For the purposes of this description, the terms “upper,” “lower,” “left,” “rear,” “right,” “front,” “vertical,” “horizontal,” and their derivatives should be associated with examples of orientation in the drawings. It is not intended to be bound by any theory expressed or implied by the foregoing technical field, background art, summary of the invention, or any of the theories expressed or implied in the following detailed description. It should also be understood that the apparatus and processes shown in the drawings and described in the following detailed description are exemplary embodiments (examples), aspects, and / or concepts defined in the appended claims. Therefore, unless otherwise stated, dimensions and other physical characteristics relating to the disclosed embodiments should not be considered limiting. It should be understood that the phrase "at least one" is equivalent to "one". Aspects (examples, changes, modifications, options, variations, embodiments, and any equivalents thereof) are described with respect to the accompanying drawings. It should be understood that the invention is limited to the subject matter provided in the claims, and that the invention is not limited to the specific aspects depicted and described. It should be understood that the scope of the meaning of "devices configured to couple to an article" (i.e., to be connected to the article, interact with the article, etc.) should be interpreted as devices configured to be directly or indirectly coupled to the article. Therefore, unless otherwise specifically stated, "configured to" can include the meaning of "directly or indirectly".

[0105] Figure 1A , Figure 1B , Figure 1C and Figure 1D A side perspective view depicting an embodiment of the flexible medical guidewire assembly 102 is shown.

[0106] For reference Figure 1A The embodiments described herein depict a device including, but not limited to, a synergistic combination of a flexible medical guidewire assembly 102 and a sensor assembly 104. The flexible medical guidewire assembly 102 is configured to be inserted into a confined space defined by a living body 902. Figure 2A or Figure 2BAn embodiment of the living body 902 is depicted. The living body 902 may include the human body, etc. The sensor assembly 104 is securely supported by (configured to be supported by) the flexible medical guidewire assembly 102. This is accomplished in such a way that once the flexible medical guidewire assembly 102 is inserted into and moved along the confined space defined by the living body 902, the sensor assembly 104 and the flexible medical guidewire assembly 102 are movable along the confined space defined by the living body 902. The flexible medical guidewire assembly 102 may include any type of flexible material. The sensor assembly 104 may include any type of sensor assembly.

[0107] For reference Figure 1A In the embodiments depicted herein, the flexible medical guidewire assembly 102 (preferably) includes a sensor assembly 104 configured to respond to stimuli (such as heat, light, sound, pressure, magnetic force, or specific motion and any equivalent thereof) and transmit the resulting signals (such as pulses for signal measurement or for operational control functions). Preferably, the flexible medical guidewire assembly 102 is configured to include (support) the sensor assembly 104. The sensor assembly 104 may include a radiation emitter, an energy emitter, an energy receiver, a magnetic flux emitter, a rare-earth magnet, and any equivalent thereof. According to embodiments, the flexible medical guidewire assembly 102 and the sensor assembly 104 are configured to be selectively attached to each other and selectively detached from each other.

[0108] For reference Figure 1A In the embodiment described herein, once the flexible medical guidewire assembly 102 is inserted into the confined space defined by the living body 902, the flexible medical guidewire assembly 102 is (preferably) configured to guide a medical device 900 (such as a catheter or any equivalent thereof) into the confined space defined by the living body 902 (e.g., Figure 2A or Figure 2B(As depicted in the image). A flexible medical guidewire assembly 102 is (preferably) configured to facilitate catheter replacement (replacement of a medical device or removal and insertion of a medical device). The flexible medical guidewire assembly 102 includes (preferably) a relatively thin and flexible wire (elongated flexible shaft) configured for insertion into a confined or tortuous space (such as a confined space defined by the living body 902). The flexible medical guidewire assembly 102 provides (preferably) a guide for subsequent insertion of a medical device 900. The medical device 900 may include a relatively rigid and / or large medical device (medical instrument), such as a catheter (medical catheter), etc. The medical device has a relatively rigidity compared to the rigidity of the flexible medical guidewire assembly 102. The catheter provides (including) a flexible tube (made of medical-grade material) configured for insertion through a narrow opening into a body cavity space such as the bladder (a confined space defined by the living body 902) for removing fluid therefrom. The catheter may be configured for insertion into the body to treat a disease or perform surgery. By modifying materials or adjusting the way catheters are manufactured, custom catheters can be made for cardiovascular, urological, gastrointestinal, neurovascular, and ophthalmic applications. Catheters can be configured to allow drainage, administration of fluids or gases, insertion of surgical instruments, and the performance of a variety of other tasks. The process of inserting a catheter is called catheterization. Catheters can include thin and flexible tubes (soft catheters), and catheters can have different levels of stiffness depending on the medical task or application. It should be understood that in cases where the catheter is too soft, a flexible medical guidewire assembly 102 can be inserted into the (same) body cavity first, and then the catheter can be inserted into the body cavity by guiding the catheter as it is pushed into the body cavity using the flexible medical guidewire assembly 102.

[0109] For reference Figure 1A In the embodiments depicted herein, the flexible medical guidewire assembly 102 (preferably) is configured to be inserted into the confined space defined by the living body 902 solely by a user (doctor or technician) or by means of any medical device previously inserted and positioned within the confined space defined by the living body 902. The flexible medical guidewire assembly 102 (preferably) is not permeated by bodily fluids located within the confined space defined by the living body 902 (once inserted into the confined space defined by the living body 902). According to a preferred embodiment, the flexible medical guidewire assembly 102 has an outer diameter (preferably) of about two (2) millimeters (mm) and an elongated length of about 30 inches to about 90 inches; it should be understood that other dimensions of the flexible medical guidewire assembly 102 are also possible. According to an embodiment, the flexible medical guidewire assembly 102 has an elongated length (preferably) of about 150 centimeters (cm) to about 260 centimeters and an outer diameter of about 0.025 inches to about 0.035 inches.

[0110] For reference Figure 1BThe embodiment depicted herein includes a flexible medical guidewire assembly 102 comprising (preferably) a core element 106 and a sheath element 108 (also referred to as a sheath portion, suffix, outer coating, etc.) surrounding the core element 106 (also referred to as a mandrel). The core element 106 and the sheath element 108 extend along an elongated length of the flexible medical guidewire assembly 102. The flexible medical guidewire assembly 102 (preferably) has a circular cross-sectional portion or profile (it should be understood that other profile shapes may be utilized).

[0111] For reference Figure 1B In the embodiment depicted, core element 106 includes (preferably) a rigid internal mandrel. Core element 106 provides (preferably) additional stiffness to the flexible medical guidewire assembly 102.

[0112] For reference Figure 1B According to the embodiment described herein, the core element 106 comprises (preferably) SAE (Society of Automotive Engineers) type 304 stainless steel. SAE type 304 stainless steel contains chromium (15% to 20%) and nickel (between 2% and 10.5%) as the primary non-ferrous components. The core element 106 comprises (according to another option) superelastic nitinol. Nitinol alloys exhibit two closely related but distinct properties: shape memory effect (SME) and superelasticity (SE; also known as pseudoelasticity or PE). Shape memory is the ability of nitinol to undergo deformation at a temperature and then recover its original undeformed shape when heated above its transition temperature. Superelasticity occurs only within a narrow temperature range above its phase transformation temperature; in this case, the undeformed shape can be recovered without heating, and the material exhibits tremendous elasticity, approximately ten (10) to thirty (30) times that of ordinary metals.

[0113] For reference Figure 1B In the embodiments depicted herein, core element 106 provides (preferably) a combination of electrical and mechanical properties. It should be understood that core element 106 need not be electrically connected or act as an electrical circuit (wire).

[0114] For reference Figure 1B In the embodiments described herein, the core element 106 has (preferably) a constant degree of stiffness (providing constant stiffness) along the length of the flexible medical guidewire assembly 102, or the degree of stiffness can vary along the length of the flexible medical guidewire assembly 102 (variable stiffness).

[0115] For reference Figure 1BIn the embodiments depicted, core element 106 may include a hollow tube, such as a hyaluronic acid tube reinforcement member. A hyaluronic acid tube is a long metal tube with micro-engineered features along its length. According to an optional embodiment, the hollow tube is configured to receive and accommodate wire 405. The hollow tube may be provided in a modular configuration, and the hollow tube may be provided with cutouts to control (adjust) the flexibility (stiffness) of the hollow tube, etc.

[0116] For reference Figure 1C In the depicted embodiment, the flexible medical guidewire assembly 102 (preferably) includes a sensor assembly 104. The sensor assembly 104 (preferably) includes a magnetic sensor device 402. The magnetic sensor device 402 may include rare-earth magnets, permanent magnets, and / or electromagnets. The magnetic sensor device 402 includes a material configured to exhibit at least one magnetic property, such as attracting other ferrous objects or aligning itself in an external magnetic field.

[0117] For reference Figure 1C In the embodiments depicted herein, sensor assembly 104 (preferably) includes an electrical sensor device 404 (biosensor, etc.) configured to transmit signals, wherein the signals may be transmitted via wire 405 and / or via radio transmitter devices (known and undepicted). Electrical sensor device 404 is configured to transmit (emit) electrical signals (biosignals) and / or receive electrical signals (biosignals). Electrical sensor device 404 is configured to detect events and / or changes in their environment and transmit information to other electronic devices (such as computer processors, etc.). Biosensors are analytical devices configured to detect chemical substances and may combine biological components with physicochemical detectors. Biosignals are signals in living organisms that can be continuously measured and monitored, and may refer to bioelectrical signals, or both electrical and non-electrical signals (both of which may be time-varying signals). It should be understood that, according to a preferred embodiment, sensor assembly 104 may include a synergistic combination of electrical sensor device 404 and magnetic sensor device 402.

[0118] For reference Figure 1CIn the embodiment depicted, the flexible medical guidewire assembly 102 (preferably) includes a wire 405 extending along the length of the flexible medical guidewire assembly 102. The wire 405 is electrically connected (directly or indirectly coupled) to the sensor assembly 104. The wire 405 extends from the sensor assembly 104 toward a terminal of the flexible medical guidewire assembly 102 (e.g., the proximal end of the flexible medical guidewire assembly 102) and terminates at the terminal of the flexible medical guidewire assembly 102 (at a termination point or terminal contact). The wire 405 may be referred to as an electrical line. In cases where the sensor assembly 104 includes multiple sensors, multiple wires 405 are deployed (once for each deployed or installed sensor assembly). The wire 405 may comprise miniaturized wires (e.g., about 34 to about 44 AWG (US wire gauge)) to free up cross-sectional space within the flexible medical guidewire assembly 102. The wire 405 may comprise copper, stainless steel, nitinol, etc. Wire 405 may include a flat strip wire with a rectangular cross-section, having a thickness (e.g., about 0.002 inches or less), and preferably minimizing its impact on the overall wire outer diameter, etc. Wire 405 may have minimized total end-to-end DC resistance. Wire 405 may have total end-to-end DC resistance (e.g., about 20 ohms or less).

[0119] For reference Figure 1C In the embodiments depicted, the flexible medical guidewire assembly 102 is (preferably) adapted to exclude the wire 405, and the sensor assembly 104 includes a radio transmitter (known and undepicted) configured to transmit radio signals. The radio transmitter is positioned on the sensor assembly 104 (the radio transmitter is an option without the use of the wire 405). It should be understood that the radio transmitter is equivalent to the wire 405.

[0120] For reference Figure 1D In the embodiment depicted, the flexible medical guidewire assembly 102 (preferably) comprises a synergistic combination of a core element 106 and a sheath element 108. The core element 106 (also referred to as a mandrel) is conductive. The sheath element 108 is electrically insulating and surrounds the core element 106.

[0121] For reference Figure 1DIn the embodiment depicted, the distal portion 110 is positioned at the end section of the core element 106 and the sheath element 108. A heating device 112 is mounted to the distal portion 110 of the flexible medical guidewire assembly 102. The heating device 112 is electrically connected to the core element 106 (which is conductive in this embodiment). A heating wire 113 may be electrically connected to (and disconnected from) the proximal end of the core element 106 (the end accessible to the user). According to a preferred embodiment, the heating device 112 includes (but is not limited to) an RF (radio frequency) transmitter. The RF transmitter is configured to provide (emit) sufficient amount of heat energy to remove, cauterize, and / or puncture (preferably by a cauterization process) adjacent (patient's) body tissue (which is positioned near the heating device 112 once the flexible medical guidewire assembly 102 is inserted into the confined space defined by the living body 902 and once the heating device 112 is activated accordingly). Ablation involves managing (applying and / or removing) heat energy near living tissue to create voids, grooves, and / or channels through the living tissue, while sealing blood vessels within the living tissue and preventing unwanted bleeding from the living tissue (thus promoting easier healing). Preferably, the proximal end of the core element 106 is configured to be electrically connected to a heating wire 113 (wherein the heating wire 113 is configured to supply power to the heating device 112 via the core element 106). According to a preferred embodiment, a flexible medical guidewire assembly 102 is provided having at least one sensor assembly 104 combined with a radio frequency transmitter (which is a tissue puncture device); the radio frequency transmitter is configured to emit a sufficient amount of heat energy to ablate tissue (tissue wall) adjacent to the radio frequency transmitter (thus creating a hole or channel through the tissue or tissue wall); this provides a technical solution for using fewer fluorescence microscopy techniques and systems during medical procedures and / or treatments (this arrangement can reduce or eliminate the need for switching between sensing and energy delivery). According to the implementation scheme, the heating device 112 is also configured to receive and / or record electrical signals, and / or configured for electrosurgical purposes.

[0122] For reference Figure 1D In the embodiments depicted, the sheath element 108 may be referred to as an outer layer or an insulating layer (electrical insulation material or insulating material). The sheath element 108 has, accommodates, or contains the wire 405. For example, the sheath element 108 may include PTFE (PTFE extrusion) and any equivalent thereof. Polytetrafluoroethylene (PTFE) is a synthetic fluoropolymer of tetrafluoroethylene. The sheath element 108 may include (define) at least one or more cavities (elongated voids) configured to receive the wire 405, etc.

[0123] For reference Figure 1DIn the embodiment depicted, the heating device 112 (preferably) includes electrodes (also referred to as distal electrodes, radio frequency (RF) electrodes, etc.). The electrodes may comprise stainless steel, nitinol, platinum and iridium alloys (blends), or mixtures thereof. The electrodes may be formed in a hemispherical dome geometry having a (preferably) diameter (e.g., about 0.015 inches to about 0.032 inches, and more preferably about 0.024 inches). The size of the exposed metallic (conductive) area is preferably about 1.2 mm² to about 2.4 mm² to ensure a relatively high current density in the case of delivering about 270 Vrms (root mean square volts) to about 400 Vrms in a unipolar manner (i.e., to a grounded patient) to achieve tissue puncture (RF puncture) of adjacent tissue of the patient (once the flexible medical guidewire assembly 102 is inserted into the confined space defined by the living body 902 and once the heating device 112 is activated). The electrodes may be configured to provide a blunt surface such that the electrodes do not inadvertently mechanically puncture tissue. Preferably, once RF energy is applied to the electrode and transmitted to the tissue, the electrode becomes effectively sharpened (for tissue removal).

[0124] For reference Figure 1A , Figure 1B , Figure 1C and Figure 1DThe embodiments described herein, the following section describes additional technical features of the embodiments of the flexible medical guidewire assembly 102. It should be understood that these are preferred embodiments and are not essential for the flexible medical guidewire assembly 102. Preferably, the flexible medical guidewire assembly 102 is configured for medical device replacement (such as catheter replacement). Preferably, the working length of the flexible medical guidewire assembly 102 is sufficient for medical device replacement (the guidewire length can be twice the length of the medical device replaced using the flexible medical guidewire assembly 102). Preferably, the flexible medical guidewire assembly 102 is configured for transseptal replacement. Preferably, the flexible medical guidewire assembly 102 has bending stiffness (preferably from about 0.001 Nm² (Newtons per square meter) to about 0.002 Nm² along most of the length of the flexible medical guidewire assembly 102). Preferably, the flexible medical guidewire assembly 102 has a stiffness similar to (equivalent to) that of a type 304 spring-tempered stainless steel wire (e.g., approximately 0.018 inches in diameter) positioned in the region of the flexible medical guidewire assembly 102 located on the atrial septum (of the heart). This preference may depend on many anatomical and environmental conditions; it should be understood that some procedures may benefit from more stiffness, while others may benefit from less. Preferably, the flexible medical guidewire assembly 102 may include a core element 106 (also referred to as a rigid mandrel) having a sheath element 108 (also referred to as a flexible sheath layer) placed or positioned above it to improve shape retention and / or provide a smooth, overall elongated profile. According to embodiments, the core element 106 has an outer diameter range (e.g., approximately 0.015 inches to approximately 0.030 inches). According to embodiments, the core element 106 comprises stainless steel and / or nitinol. According to one embodiment, the sheath element 108 includes a material that contributes minimally to the stiffness of the flexible medical guidewire assembly 102. According to one embodiment, the sheath element 108 includes an insulating material (such as PTFE (polytetrafluoroethylene)). According to one embodiment, the sheath element 108 includes a flexible steel ring. According to one embodiment, the sheath element 108 has a thickness such that the outer diameter of the flexible medical guidewire assembly 102 is in the range of about 0.032 inches to about 0.035 inches.

[0125] According to the 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 vessels. According to the embodiment, the flexible medical guidewire assembly 102 comprises radio-visible material. According to the embodiment, the flexible medical guidewire assembly 102 is configured to withstand treatments (such as user forces and / or environmental forces) to be experienced during medical (cardiac) procedures (treatment or diagnostic procedures). According to the embodiment, for medical guidewires with dimensions ranging from about 0.032 inches to about 0.035 inches (preferably, no loosening or separation of sections or portions of the flexible medical guidewire assembly 102), the flexible medical guidewire assembly 102 conforms to international medical standards that specify minimum tension, such as about ten (10) Newtons. According to the embodiment, the electrical connections of the flexible medical guidewire assembly 102 (at the distal end) require sufficient end-to-end electrical insulation to mitigate interference (environmental interference). According to the embodiment, the flexible medical guidewire assembly 102 conforms to international medical standards for electrosurgical devices, which specify minimum electrical insulation performance of the guidewire (for the protection of patients and / or medical technicians). According to the embodiment, the flexible medical guidewire assembly 102 includes a radio frequency (RF) device (also known as a heating device) configured to deliver (preferably) about 270 Vrms to 400 Vrms (volt mean square) (preferably in a monopolar configuration) for distal tissue puncture or tissue removal. According to the embodiment, the flexible medical guidewire assembly 102 includes a sheath element 108; the sheath element 108 includes an insulating material with a thickness of about 0.00275 inches (such as PTFE) or more, wherein the sheath element 108 is positioned on any voltage-bearing conductor located in the flexible medical guidewire assembly 102 (such as core element 106 or other wires, etc.) to meet current leakage requirements. For example, the maximum size of the core element 106 may be (preferably) about 0.029 inches so that the outer diameter of the flexible medical guidewire assembly 102 remains (preferably) below about 0.035 inches. According to an embodiment, the sheath element 108 includes a relatively thick electrical insulator (for ease of manufacture). The thickness can be set to vary the effective outer diameter of the flexible medical guidewire assembly 102. For example, this could be for the core element 106, which has a diameter (preferably) of about 0.018 inches and is made of stainless steel. The sheath element 108 includes a relatively thick PTFE layer to achieve an outer device diameter (preferably) of about 0.035 inches for the flexible medical guidewire assembly 102. According to an embodiment, sensor devices (medical sensors, electrodes, etc.) are positioned onto the flexible medical guidewire assembly 102. For example, the sensor devices can be configured for low-voltage electrical communication (e.g., for ECG recording) and do not require a relatively thick insulator, and can be protected from primary energy and interference (preferably end-to-end).According to the implementation plan, the flexible medical guidewire assembly 102 can be biocompatible, maneuverable, and robust.

[0126] Figure 2A and Figure 2B Depicting Figure 1A , Figure 1B , Figure 1C and / or Figure 1D A front view of an embodiment of the flexible medical guidewire assembly 102.

[0127] For reference Figure 2A In the embodiment depicted, the signal measurement system 904 (also referred to as the signal analysis system) is configured to be electrically connected (selectively electrically connected, coupled) to the sensor interface system 906. The definition of "electrical connection" includes electromagnetic connection, magnetic connection, acoustic connection, photonic connection, etc. The signal measurement system 904 may include, for example, an electromagnetic system, an electroanatomical mapping system (3D or 2D), or an electroanatomical non-fluorescent transillumination mapping system, etc. The sensor assembly 104 includes, for example, a magnetic sensor device 402 (according to...). Figure 2A (As depicted). Sensor interface system 906 is configured to interact with sensor assembly 104. Sensor interface system 906 is configured to exchange (receive and / or transmit) signals (information) with sensor assembly 104 (once sensor interface system 906 interfaces with sensor assembly 104, and once sensor assembly 104 is activated). Signal exchange may include causing sensor interface system 906 to transmit signals to and / or receive signals from sensor assembly 104. For example, Figure 2A In the embodiment depicted, sensor assembly 104 includes a magnetic device, and sensor interface system 906 is configured to magnetically interact with sensor assembly 104.

[0128] For reference Figure 2B The embodiment described herein includes a flexible medical guidewire assembly 102 comprising wire 405 ( Figure 2B Not described in the text, but Figure 1C (As depicted in the implementation scheme). Sensor assembly 104 includes (preferably) an electrical sensor device 404. Flexible medical guidewire assembly 102 includes an electrical connector 810. Figure 9B , Figure 9C , Figure 9D , Figure 9E , Figure 9F , Figure 10A , Figure 10B , Figure 11A , Figure 11B , Figure 11C , Figure 12A , Figure 12B and Figure 12CAn embodiment of the electrical connector 810 is depicted. The electrical connector 810 is configured to be electrically connected to (selectively connected to and disconnected from) a wire 405 of the flexible medical guidewire assembly 102. The electrical connector 810 is also configured to be electrically connected to (selectively connected to and disconnected from) a sensor interface system 906. The sensor interface system 906 is configured to modulate a signal received from the sensor assembly 104 and (then) provide the modulated signal to a signal measurement system 904 (also referred to as a signal analysis system). According to one option, the sensor interface system 906 is configured to be electrically connected to (selectively connected to and disconnected from) the signal measurement system 904. According to another option, the sensor interface system 906 is electrically connected to the signal measurement system 904. The electrical connector 810 is configured to communicate electrically with the sensor assembly 104 (e.g., via...) once connected to (operably connected thereto). Figure 1C (The wire 405 is depicted in the image). The electrical connector 810 is also configured to be electrically connected to the sensor interface system 906. Preferably, the grounding element 908 (grounding pad) is configured to be in physical contact with the living body 902 (preferably removably adhered to or in close, separable contact with the skin of the living body 902). The grounding element 908 is spaced apart from the sensor assembly 104. The grounding element 908 is (preferably) positioned close to the sensor assembly 104 (at the area of ​​interest for obtaining a signal via the sensor assembly 104). The sensor interface system 906 is configured to communicate electrically with the sensor assembly 104 once (A) the sensor interface system 906 is electrically connected to the wire 405 (via the electrical connector 810) and (B) the grounding element 908 is positioned to simulate physical contact with the living body 902.

[0129] Figure 3 Depicting Figure 1D A front perspective view of an embodiment of the flexible medical guidewire assembly 102 (wherein...) Figure 3 Some of the technical features described herein can be applied to, for example Figure 1A , Figure 1B and Figure 1C The implementation scheme described herein (if applicable).

[0130] For reference Figure 3 In the embodiment depicted, the flexible medical guidewire assembly 102 (according to a preferred embodiment) is configured to provide (including) a heating device 112. The heating device 112 is configured to emit RF (radio frequency) energy from the (distal end) of the flexible medical guidewire assembly 102 and penetrate adjacent tissue of the living body 902 (e.g., as shown in the image). Figure 2B(As depicted in the embodiments). Core element 106 is provided with a relatively rigid and conductive material (positioned along a central radial axis that extends along the length of the flexible medical guidewire assembly 102). Sheath element 108 includes an electrically insulating material (preferably a polymer layer) covering core element 106. Sheath element 108 (preferably) also includes an outer polymer layer covering sheath element 108 (if desired). For example, sheath element 108 may include a plastic material having electrically insulating properties suitable for wiring, cable, and / or electrical shielding tasks, and sufficient performance properties (dielectric strength, thermal properties, insulation and corrosion resistance, water resistance, and heat resistance) to ensure safety performance meets industrial and regulatory safety standards. When selecting appropriate materials, please refer to the following publication: *Plastics in Medical Devices: Properties, Requirements, and Applications; 2nd Edition; Author: ViNNyR. Sastri; Hardcover ISBN: 9781455732012; Publication Date: November 21, 2013; Publisher: Amsterdam [Pays-Bas]: Elsevier / William ANdrew,

[2014] .* The core element 106 terminates in (and is electrically connected to) a heating device 112 (also referred to as a blunt dome 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 organism 902 (once activated accordingly). The core element 106 also includes a core terminal portion 106A extending from the proximal end of the core element 106. The core terminal portion 106A is exposed (not at least partially covered with an electrically insulating material). The core terminal portion 106A is configured for electrical connection to an auxiliary device (known and undescribed, such as an RF generator, etc.). Flexible medical guidewire assembly 102 (e.g.) Figure 3 The device (as depicted) is configured to perform (form) RF (radiofrequency) punctures into the patient's tissue (for forming transseptal punctures, etc.). The technical effect or advantage of the heating device 112 is that it can reduce the number of medical device replacements (insertion and removal of a flexible medical guidewire assembly 102 having a confined space defined by the living body 902) required for procedures such as TSP (transseptal puncture) and cardiac catheterization (which require the heating device 112). Minimizing medical device replacements within the patient to mitigate the risk of unwanted medical events or conditions (such as air embolism) may be in the benefit of both the patient (living body 902) and the physician. For example, Figure 3 In the preferred embodiment depicted, the core element 106 is conductive, and the heating device 112 is electrically connected to the core element 106.

[0131] For reference Figure 3In the embodiments depicted, the sheath element 108 is configured to provide electrical insulation (towards electrical insulation) to the core element 106. To provide electrical safety to patients and users (such as physicians or medical technicians handling the flexible medical guidewire assembly 102), and additionally to provide efficient current delivery to the heating device 112 (such as a distal electrode configured for radiofrequency (RF) tissue removal and / or tissue ablation), the core element 106 (or an equivalent alternative high-voltage wire) may require a substantial (sufficient) amount of electrical insulation. PTFE is a preferred material for high-voltage RF insulation due to its relatively high electrical properties, biocompatibility, and flexibility. PTFE can also be used as a heat-shrinkable material (format) to ensure conformal adhesion to the core element 106 (the energized mandrel) and to effectively utilize the available space in the flexible medical guidewire assembly 102 (i.e., to mitigate the space consumed by gaps between wires and / or hollow elongated extrusion voids or cavities extending inward along the longitudinal length of the flexible medical guidewire assembly 102). The flexible medical guidewire assembly 102 may have an outer diameter of approximately 0.035 inches and may require effective insulation of PTFE material with a wall thickness of approximately 0.003 inches to meet the current (ampere) leakage requirements of electrosurgical medical standards. Preferably, the maximum inner diameter of the core element 106 is approximately 0.029 inches (as allowed within manufacturing tolerances).

[0132] For reference Figure 3 In the embodiment described herein, sensor assembly 104 includes at least one electrical sensor.

[0133] For reference Figure 3In the embodiment depicted, the sensor assembly 104 (such as an electrical sensor) includes a first electrical sensor device 404A (also referred to as a proximal electrode) and an Nth electrical sensor device 404N (where N is any integer from 1, 2, 3, etc.). The first electrical sensor device 404A and the Nth electrical sensor device 404N are spaced apart from each other and are fixedly positioned along the longitudinal length of the flexible medical guidewire 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 sheath element 108. A first wire 405A is electrically connected to the first electrical sensor device 404A (etc.). The first wire 405A is embedded within the flexible medical guidewire assembly 102. The first wire 405A extends along the length of the flexible medical guidewire assembly 102 from the first electrical sensor device 404A to the proximal end (terminal) of the flexible medical guidewire assembly 102, and so on for the remaining wires. The Nth wire 405N is electrically connected to the Nth electrical sensor device 404N. The Nth wire 405N extends along the length of the flexible medical guidewire assembly 102 from the Nth electrical sensor device 404N to the proximal end (terminal) of the flexible medical guidewire assembly 102. The Nth wire 405N is embedded within the flexible medical guidewire assembly 102. A sheath element 108 (electrical insulation layer) covers and electrically insulates the first wire 405A and the Nth wire 405N. The first wire 405A and the Nth wire 405N are aligned parallel to the core element 106. The first wire 405A and the Nth wire 405N terminate at the core terminal portion 106A. According to a preferred embodiment (e.g.) Figure 3 As depicted in the illustration, the heating device 112 and the multiple electrical sensor devices (404A, 404N) are electrically insulated from each other (to avoid any electrical and / or magnetic interference between these devices). When selecting appropriate materials, please refer to the following publication: Plastics in Medical Devices: Properties, Requirements, and Applications; Second Edition; Author: Vinny R. Sastri; Hardcover ISBN: 9781455732012; Publication Date: November 21, 2013; Publisher: Amsterdam [Pays-Bas]: Elsevier / William Andrew,

[2014] .

[0134] For reference Figure 3 In the embodiment described herein, the core terminal portion 106A (proximal electrical connection) is located at the terminal of the core element 106. For example... Figure 2BAs depicted in the embodiments, the core terminal portion 106A is exposed for electrical connection to the measurement system (via electrical wiring). Preferably, the core terminal portion 106A extends from the end segment of the core element 106 (such as axially).

[0135] For reference Figure 3 In the embodiments described herein, the electrical sensor device (404A, 404N) may include a conductive ring configured to engage with the outer surface of the sheath element 108.

[0136] The electrical sensor devices (404A, 404N) can be forged or glued to the outer surface of the flexible medical guidewire assembly 102.

[0137] Electrical sensor devices (404A, 404N) may include gold and / or steel.

[0138] For reference Figure 3 In the embodiments depicted, the sensor assembly 104 (electrical sensor device) may include at least one exposed portion of a wire 405, such as a portion of a wire (405A, 405N) exposed to (or positioned on) the outer surface of the flexible medical guidewire assembly 102. The exposed portion of the wire 405 is exposed without positioning the sheath element 108 over the exposed portion of the wire 405. In this way, the wire 405 being exposed to tissue (e.g., a patient's blood flow) can provide electrical communication and signal sensing capabilities using other medical devices (e.g., an electrocardiograph). It should be understood that, where the wire 405 is present inside the flexible medical guidewire assembly 102 and extends along its length, a window is formed by the sheath element 108 that can expose the wire 405 used as an electrode in the sensor assembly 104. In this way, the sensor assembly 104 may include the exposed portion of the wire 405 (i.e., the wire 405 is exposed to the outside of the sheath element 108).

[0139] For reference Figure 3 In the embodiment depicted, sensor assembly 104 includes (according to the embodiment) an exposed portion of wire 405 exposed on the outer surface of flexible medical guidewire assembly 102. Wire 405 extends along the length of flexible medical guidewire assembly 102. Wire 405 extends toward a terminal of flexible medical guidewire assembly 102. Wire 405 terminates (electrically connected to) a terminal contact located at or situated at an end portion of flexible medical guidewire assembly 102.

[0140] Figure 4 Depicting Figure 1D A front perspective view of an embodiment of the flexible medical guidewire assembly 102 (wherein...) Figure 4 Some of the technical features described herein can be applied to, for example Figure 1A , Figure 1B and Figure 1C The implementation scheme described herein (if applicable).

[0141] For reference Figure 4 In the embodiment depicted, the first electrical sensor device 404A and the Nth electrical sensor device 404N are countersunk (positioned) below the outer diameter (outer surface) of the sheath element 108. The technical advantage of this arrangement is that it allows the flexible medical guidewire assembly 102 to slide relatively more easily along the confined space defined by the living body 902 (e.g., Figure 2A or Figure 2B As depicted in the implementation scheme). In this implementation scheme (such as... Figure 4 As depicted in the text, the first electrical sensor device 404A and the Nth electrical sensor device 404N are configured to transmit signals to the external environment (for electrical recording by external medical devices, etc.) via wires (405A, 405N) through a spatially separated window (gap) formed in the outermost layer (upper) of the sheath element 108.

[0142] Figure 5 Depicting Figure 1D A front perspective view of an embodiment of the flexible medical guidewire assembly 102 (wherein...) Figure 5 Some of the technical features described herein can be applied to, for example Figure 1A , Figure 1B and Figure 1C The implementation scheme described herein (if applicable).

[0143] For reference Figure 5 The flexible medical guidewire assembly 102, as described in the embodiment, also includes (but is not limited to) a braided element 406.

[0144] A braided element 406 is positioned within the body of the flexible medical guidewire assembly 102. The braided element 406 may comprise a metal alloy. The braided element 406 is elastic and flexible (elastically deformable). The braided element 406 comprises braided threads having strands woven together. The braided element 406 is positioned below the outer surface of the flexible medical guidewire assembly 102. The braided element 406 is spaced apart from (and surrounds) the core element 106. The braided element 406 is configured to improve the stiffness and / or torsional rigidity of the flexible medical guidewire assembly 102. For example, in cases where it is necessary to minimize the diameter of the flexible medical guidewire assembly 102 (and therefore the stiffness of the core element 106), the braided element 406 can restore some of the stiffness of the flexible medical guidewire assembly 102.

[0145] Figure 6A and Figure 6B Depicting Figure 1D Axial cross-sectional view of the embodiment of the flexible medical guidewire assembly 102 ( Figure 6A ) and radial section diagram ( Figure 6B(such as) Figure 6A and / or Figure 6B Some of the technical features described herein can be applied to, for example Figure 1A , Figure 1B and Figure 1C The implementation scheme described herein (if applicable).

[0146] For reference Figure 6A and Figure 6B In the embodiments depicted, the stiffness of the flexible medical guidewire assembly 102 is preferably provided by a combination of wires, such as wires (first wire 405A, second wire 405B, and Nth wire 405N), rather than by the core element 106 (or alternatively, the core element 106 is not provided). That is, the first wire 405A, second wire 405B, and Nth wire 405N are relatively large (to increase the stiffness of the flexible medical guidewire assembly 102); the core element 106 may or may not be included with the flexible medical guidewire assembly 102. In cases where the core element 106 is included (deployed), its diameter can be reduced to improve the manufacturability and positioning of the first electrical sensor device 404A (proximal electrode) and the Nth electrical sensor device 404N (proximal electrode), etc. A core insulation layer 106B is positioned above the core element 106. A sheath inlet 108A (gap) is formed in the central region of the sheath 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 sheath inlet 108A. The technical advantage of this embodiment is that once the flexible medical guidewire assembly 102 is bent, the wires can flex and bend without causing electrical open circuits or short circuits.

[0147] According to such Figure 6A and Figure 6BIn the embodiment depicted, the diameter (also referred to as the core axis) of the core element 106 is (preferably) reduced. For example, the core element 106 comprises an elongated filament (relatively thin filament for lower voltage capability) extending along the longitudinal length of the flexible medical guidewire assembly 102. The core element 106 has a relatively low surface area and / or diameter, and this arrangement provides additional space for other components (for placement within and along the elongated length of the sheath element 108 (also referred to as the insulation layer)). The outer dimension (diameter) of the first wire 405A may be increased to provide increased mechanical stiffness of the flexible medical guidewire assembly 102. To balance the stiffness profile of the flexible medical guidewire assembly 102 (e.g., to provide a relatively soft end portion, a relatively stiff proximal body portion, etc.), the profile (outer diameter) of the core element 106 and / or the wire 405 may vary along the longitudinal length of the flexible medical guidewire assembly 102. For example, a relatively long instance of core element 106 may include a reduction in outer diameter and cross-sectional area along its length to provide desired flexibility (regional flexibility) for selected portions of the flexible medical guidewire assembly 102. For example, the outer diameter of core element 106 may increase toward the distal end (of the flexible medical guidewire assembly 102) to improve fixation and stiffness at the most distally positioned medical device (such as a medical sensor device).

[0148] Figure 7A , Figure 7B , Figure 7C , Figure 7D and Figure 7E Depicting Figure 1D A radial cross-sectional view of an embodiment of the flexible medical guidewire assembly 102 (wherein, as shown) Figure 7A , Figure 7B , Figure 7C , Figure 7D and / or Figure 7E Some of the technical features described herein can be applied to, for example Figure 1A , Figure 1B and Figure 1C The implementation scheme described herein (if applicable).

[0149] For reference Figure 7AIn the embodiment depicted, a first wire insulation layer 407A is placed above a first wire 405A, and so on for each wire. A second wire insulation layer 407B is placed above a second wire 405B. A Nth wire insulation layer 407N is placed above a Nth wire insulation layer 407N. The outer diameter of the core element 106 is 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 located within the sheath inlet 108A and are arranged coaxially along the length (longitudinal axis) of the flexible medical guidewire assembly 102. According to the embodiment, the core element 106, the first wire 405A, the second wire 405B, and the Nth wire 405N (preferably) are electrically insulated from each other (and from the patient, etc.). According to another embodiment, the first wire 405A, the second wire 405B, and the Nth wire 405N (preferably) are electrically insulated from each other and from the patient (in the case that the core element 106 is non-conductive). The flexible medical guidewire assembly 102 has an outer diameter of (preferably) about 0.032 inches to about 0.035 inches. The core element 106 has or includes an outer diameter of (preferably) about 0.018 inches (preferably, SAE 304 spring-strengthened stainless steel). Electrical insulation layers (such as...) Figure 6B The core insulation layer 106B (also referred to as the main insulator) depicted is positioned above the core element 106 and has a thickness of (preferably) about 0.003 inches. The wires (405A, 405B, 405N, etc.) can have any suitable cross-section or profile, such as a circular or 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 above each of the wires (405A, 405B, 405N, etc.) can have a thickness of about 0.003 inches (or greater).

[0150] Sufficient space exists within or on the flexible medical guidewire assembly 102 to allow for the placement of sensor devices (e.g., also known as...). Figure 6A (The annular electrode depicted in the image). According to an embodiment, the sensor device (proximal electrode) can be placed (positioned) in a relatively soft portion of the flexible medical guidewire assembly 102, where the outer diameter of the core element 106 has been reduced to improve its softness. The soft region (of the flexible medical guidewire assembly 102) may comprise a stainless steel material (slender mandrel) ranging from about 0.006 inches to about 0.010 inches (diameter). In this case, the diameter limitation is reduced to provide additional space for terminating connectors to the sensor device (proximal electrode), etc.

[0151] For reference Figure 7BIn the embodiment depicted, the core insulation layer 106B is positioned above the core element 106. A sheath inlet 108A is located between the outer surface of the core insulation layer 106B and the inner surface of the sheath element 108. A first wire 405A, a second wire 405B, and an Nth wire 405N are positioned within the sheath inlet 108A (between the sheath element 108 and the core insulation layer 106B). The sheath inlet 108A forms a polygonal geometry (e.g., having a multi-angle cross-section, wherein the wires are positioned at the vertices of the polygonal geometry (such as a triangle).

[0152] For reference Figure 7C In the embodiment depicted, the core insulation layer 106B defines a recess configured to receive a corresponding wire (405A, 405B, 405N). The outer shape of the core insulation layer 106B has a circular or annular cross-sectional shape. The inner surface shape of the sheath element 108 has a circular or annular cross-sectional shape conforming to the outer shape of the core insulation layer 106B. The core insulation layer 106B surrounds the core element 106.

[0153] For reference Figure 7D The implementation scheme described herein provides, for example, Figure 7B Similar implementations are described in the text, wherein the wires (405A, 405B, 405N) each have a corresponding electrical insulation layer thereon (e.g. Figure 7A (As depicted in the implementation plan).

[0154] For reference Figure 7E In the embodiment depicted, sheath element 108 defines (provides) sheath channels (first sheath channel 109A, second sheath channel 109B, and Nth sheath channel 109N). Each of the wires (405A, 405B, 405N) is received in the corresponding sheath channel (109A, 109B, 109N). It should be understood that in this embodiment, core insulation layer 106B is optional.

[0155] According to such Figures 7A to 7EIn the embodiments depicted, increased relative movement (and / or relaxation) between the wires (405A, 405B, 405N) can provide additional flexibility to the flexible medical guidewire assembly 102. The core element 106 (also referred to as a mandrel, which may be conductive) is configured to provide most of the mechanical stiffness (relative to the sheath element 108 and the wires (405A, 405B, 405N)). The sheath element 108 (also referred to as a coating) is configured to provide sufficient electrical insulation to withstand relatively high voltages and / or currents from 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) may be configured to handle relatively low or relatively high voltages, etc. The sheath element 108 may be flexible and may be lubricated (may be smooth and lubricated with oil or similar substances).

[0156] Figure 8A and Figure 8B Depicting Figure 1D A radial cross-sectional view of an embodiment of the flexible medical guidewire assembly 102 (wherein, for example...) Figure 8A and / or Figure 8B Some of the technical features described herein can be applied to, for example Figure 1A , Figure 1B and Figure 1C The implementation scheme described herein (if applicable).

[0157] For reference Figure 8A In the embodiment depicted, sheath element 108 defines (forms) a sheath inlet 108A (having a circular cross-sectional profile). Core insulation layer 106B is placed above core element 106, each core element having a semi-circular cross-sectional profile. Core element 106 is formed in an offset (non-circular) shape. Core element 106 and core insulation layer 106B are received in at least a portion of sheath inlet 108A, thereby opening a portion of sheath inlet 108A and making it available for receiving wires (405A, 405B, 405N). Each of the wires (405A, 405B, 405N) has an electrical insulation layer (such as a first wire insulation layer 407A, etc.). Core element 106 is formed in a shape configured to provide additional space to improve the manufacturability and scalability of the wires (405A, 405B, 405N).

[0158] For reference Figure 8B In the embodiment depicted, the core insulation layer 106B forms a gap configured to receive wires (405A, 405B, 405N). The core insulation layer 106B forms two gaps (cavities); one cavity for receiving the core element 106, and the other cavity for receiving the wires (405A, 405B, 405N).

[0159] Figure 9A Depicting Figure 1D A side view of an embodiment of the flexible medical guidewire assembly 102 (wherein, for example) Figure 9A Some of the technical features described herein can be applied to, for example Figure 1A , Figure 1B and Figure 1C The implementation scheme described herein (if applicable). Figure 9B , Figure 9C , Figure 9D , Figure 9E and Figure 9F Depicting configurations that can be connected to Figure 9A A side view of an embodiment of the electrical connector 810 of the flexible medical guidewire assembly 102.

[0160] For reference Figure 9A In the embodiment depicted, the core terminal portion 106A extends (axially) from the end portion (proximal portion or user-accessible portion) of the core element 106. The core terminal portion 106A is exposed (for electrical connection, where 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 (where the core element 106 is required to be conductive).

[0161] For reference Figure 9B and Figure 9C In the embodiment depicted, electrical connector 810 is configured to selectively connect to (clamp to) the core terminal portion 106A. Electrical connector 810 may include clamp connectors, wire clips, etc., and any equivalents thereof. Electrical connector assembly 810 includes connector terminals 811 (electrical connector contacts, jaw portions, etc.), such as a pair of opposing jaws (springs biased to normal closure, etc.). According to an embodiment, electrical connector assembly 810 is configured to connect to electrical terminals (terminal portion 409, electrical connection) located at the proximal end of the flexible medical guidewire assembly 102. The electrical terminals are electrically connected to, for example... Figure 3The electrical sensor device 404A and / or medical device (such as heating device 112) depicted in the figures are mounted to a portion (such as the distal portion) of the flexible medical guidewire assembly 102. The electrical connector assembly 810 is also configured to connect the electrical terminals of external devices (such as known and undepicted signal generators or signal recording systems) to the electrical terminals of the flexible medical guidewire assembly 102 (at least one or more instances of the terminal portion 409). This is preferably accomplished in such a way that the nominal diameter of the flexible medical guidewire assembly 102 (e.g., about 0.032 inches to about 0.035 inches) can be maintained. Preferably, the electrical connector assembly 810 provides conductive pins configured to allow (facilitate) electrical connection to the electrical terminals (terminal portion 409) of the flexible medical guidewire assembly 102 by a single user movement (for convenience). Alternatively, the electrical connector assembly 810 is configured to provide conductive pins configured to allow (facilitate) electrical connections between the electrical terminals of the flexible medical guidewire assembly 102 and multiple selective independent connections, etc.

[0162] For reference Figure 9D In the embodiment depicted, a 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 (e.g., if the core terminal portion 106A is conductive). At least one terminal portion (409A, 409B, 409N) (also referred to as a proximal electrical connector or wire terminal) is electrically coupled to... Figure 3 , Figure 4 and / or Figure 5 The respective electrical sensor devices (404A, 404N) depicted in any of the embodiments. For example, a first terminal portion 409A (wire terminal, proximal connection) is electrically coupled to the first electrical sensor device 404A (via, for example...) Figure 3The first wire 405A is depicted in the diagram. The second terminal portion 409B (proximal electrode) is electrically coupled to the second electrical sensor device (not depicted, but easily observable given the first electrical sensor device 404A). 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 (axially spaced) along the length of the sheath element 108 and are positioned on the outer surface of the sheath element 108, near the end of the flexible medical guidewire assembly 102 (near the core terminal portion 106A). According to a preferred embodiment, the flexible medical guidewire assembly 102 is configured to facilitate catheter replacement by leaving the proximal end (the end portion near the user) without a handle, allowing the catheter to traverse the length (the entire length) of the flexible medical guidewire assembly 102; where the handle is positioned at the proximal end, the catheter may not be able to traverse the length of the flexible medical guidewire assembly 102. According to a preferred embodiment, the flexible medical guidewire assembly 102 includes multiple instances of a sensor assembly 104, wherein the sensor assembly 104 can be connected to a measuring device (such as...). Figure 2A or Figure 2B (As depicted in the text).

[0163] For reference Figure 9E and Figure 9F In the embodiment depicted, the electrical connector assembly 810 has connector terminals 811. Connector terminals 811 are configured to selectively electrically connect (and selectively electrically disconnect) with at least one terminal portion 409 of the flexible medical guidewire assembly 102. The flexible medical guidewire assembly 102 is configured to be inserted into a confined space defined by a living body 902 (e.g., Figure 2A or Figure 2B (As depicted in the image). The terminal portion 409 (also referred to as a terminal block) is electrically connected via wire 405 to the sensor assembly 104 (as shown in the image). Figure 1C or Figure 1D (as described in etc.)

[0164] For reference Figure 9E and Figure 9FIn the embodiments depicted, the electrical connector assembly 810 is configured to (preferably) selectively connect to (and selectively disconnect from) the terminal portions (409A, 409B, 409N, 106A) (electrical terminals, exposed electrical terminals) of the flexible medical guidewire assembly 102 (and selectively disconnect from) them. The terminal portions may include, for example, a core terminal portion 106A (where the core terminal portion 106A is conductive) and terminal portions (409A, 409B, 409N) (also referred to as electrical portions, multiple proximal electrodes, etc., which can be used for sensor devices, etc.). Where the core terminal portion 106A is not required (not deployed as a wire), the electrical connector assembly 810 is configured to selectively connect to (and selectively disconnect from) the terminal portions (409A, 409B, 409N) or at least one or more terminal portions connected to at least one electrical sensor device 404 (e.g., Figure 3 (As depicted in Figure 1). The electrical connector assembly 810 includes connecting wires 812, such as connecting wires (812A, 812B, 812D, 812N). The connecting wires 812 are (preferably) long enough to provide a sufficient amount of slack for spatial movement of the flexible medical guidewire assembly 102 (i.e., to provide disconnection for auxiliary medical devices such as radio frequency generators, signal recording systems, etc.). The connecting wires 812 include (preferably) multiple connecting wires (812A, 812B, 812D, 812N). Selective disconnection and removal of the electrical connector assembly 810 from the terminal portions (409A, 409B, 409N, 106A) of the flexible medical guidewire assembly 102 allows the flexible medical guidewire assembly 102 to be used with medical device 900 (as depicted in Figure 1) and / or other medical devices (such as catheters (such as catheter replacement devices) etc.).

[0165] For reference Figure 9E and Figure 9F In the embodiment depicted, 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). The connector terminals 811 are configured to be electrically connected to at least one terminal portion 409 of the flexible medical guidewire assembly 102. The flexible medical guidewire assembly 102 is configured to be inserted into a confined space defined by a living body 902 (as described above and...). Figure 2A or Figure 2B (As depicted in the image). Terminal portion 409 is exposed (electrically exposed) for electrical connection to connector terminal 811. Terminal portion 409 (electrical terminal) is electrically connected to sensor assembly 104 via wire 405 (e.g., as shown in the image). Figure 3(As depicted in the implementation scheme). The terminal portion 409 is positioned at the proximal end of the flexible medical guidewire assembly 102. The terminal portion 409 is exposed for selective electrical connection with the electrical connector assembly 810. The sensor assembly 104 and the wire 405 are supported by the flexible medical guidewire assembly 102 (this is accomplished in such a way that once the flexible medical guidewire assembly 102 is inserted into and moved along the confined space defined by the living body 902, the sensor assembly 104 and the flexible medical guidewire assembly 102 are movable along the confined space defined by the living body 902).

[0166] For reference Figure 9E and Figure 9F In the embodiments depicted, the connector terminals 811 of the electrical connector assembly 810 include (preferably) connector terminals (811A, 811B, 811N, 811D) for the respective terminal portions (409A, 409B, 409N, 106A). For cases where a heater device or other medical device is deployed in or with the flexible medical guidewire assembly 102, the core terminal portion 106A can be used or deployed as a wire. For example, the connector terminals (811A, 811B, 811N, 811D) preferably include a first pair of jaws (for electrical connection to the first terminal portion 409A), a second pair of jaws (for electrical connection to the second terminal portion 409B), an Nth pair of jaws (for electrical connection to the Nth terminal portion 409N), and a pair of core jaws (for electrical connection to the core terminal portion 106A). Connecting wires (812A, 812B, 812D, 812N) are electrically connected to connector terminals (811A, 811B, 811N, 811D) respectively. The first connecting wire 812A is electrically connected to the first connector terminal 811A. The second connecting wire 812B is electrically connected to the second connector terminal 811B. The Nth connecting wire 812N is electrically connected to the Nth connector terminal 811N. The fourth connecting wire 812D is electrically connected to the third connector terminal 811D (for connection to the core terminal portion 106A).

[0167] For reference Figure 9E and Figure 9F In the embodiment depicted, the electrical connector assembly 810 includes a side-loaded removable electrical connector. The electrical connector assembly 810 includes, for example, and supports a plurality of spaced-apart clamps mounted to (or extending therefrom) the electrical connector assembly 810.

[0168] For reference Figure 9F In the embodiment depicted, the electrical connector assembly 810 includes an asymmetric hairpin connector having a hard stop formed in the alligator teeth and a variable clearance to mitigate misconnection and ensure proper connection. Figure 3The depicted electrical sensor devices (404A, 404N) are correctly electrically connected. Connector terminal 811A is keyed for keying connection to the first terminal portion 409A. The third connector terminal 811D (such as a jaw) is keyed for keying connection to the core terminal portion 106A. If the core terminal portion 106A is not deployed as a wire, the third connector terminal 811D, etc., is not used.

[0169] For reference Figure 9F In the embodiment depicted, the electrical connector assembly 810 includes a handle 814 extending from the housing assembly 816. A first connector terminal 811 is supported by the housing assembly 816. A connecting wire 812 is supported by the housing assembly 816.

[0170] Figure 10A and Figure 10B Depicting configurations that can be connected to Figure 1D A side view of an embodiment of the electrical connector 810 of the flexible medical guidewire assembly 102 (wherein... Figure 10A and / or Figure 10B Some of the technical features described herein can be applied to, for example Figure 1A , Figure 1B and Figure 1C The implementation scheme described herein (if applicable).

[0171] For reference Figure 10A In the embodiment depicted, the electrical connector assembly 810 is configured to electrically interface (interact) with the end portion (proximal end portion) of the flexible medical guidewire assembly 102. The electrical connector assembly 810 is configured to be reverse-loaded (reverse-connected) to the flexible medical guidewire assembly 102. The electrical connector assembly 810 defines (provides) a connector channel 824 configured to receive (at least partially axially receive) the length of the end portion of the flexible medical guidewire assembly 102. The electrical connector assembly 810 includes a button 820 positioned on a surface (such as a top surface) of the electrical connector assembly 810. The electrical connector assembly 810 includes connector conductors 822 (electrodes, etc.). Button 820 is configured to (A) be activated by a user (such as a doctor) to selectively move connector conductor 822, and (B) selectively connect connector conductor 822 to end portions (such as core terminal portion 106A) of flexible medical guidewire assembly 102 once the end of the flexible medical guidewire assembly 102 is received in connector channel 824 (and once button 820 is activated accordingly).

[0172] For reference Figure 10AIn the embodiments depicted herein, the electrical connector assembly 810 is also configured to provide an in-line connector. An upper instance of the electrical connector assembly 810 is described as being in a loaded position (not activated), where the button 820 is not pressed or activated by a user (such as a physician). A lower instance of the electrical connector assembly 810 is depicted as being in a locked and engaged position, where the button 820 is engaged or activated. For the upper instance of the electrical connector assembly 810, the button 820 is ready to be pressed (by a user or physician). Once the button 820 is pressed (as shown in the lower instance of the electrical connector assembly 810), the connector conductor 822 is clamped and electrically engaged (with) the terminal portion 409 (such as the core terminal portion 106A) with the assistance of the spring member 818. It should be understood that the same mechanism can be utilized for cases where multiple instances of the terminal portion 409 exist. Each unique electrical connection (i.e., for each instance of the terminal portion 409) may need to travel independently to ensure full engagement with each connector facing the corresponding terminal portion of the flexible medical guidewire assembly 102. Alternatively, a biased connection to the terminal portion 409 (e.g., the core terminal portion 106A) can ensure that a connection can only be made after other terminal portions (of the flexible medical guidewire assembly 102) have made electrical contact with the electronic components of the electrical connector assembly 810.

[0173] For reference Figure 10B In the embodiment depicted, the upper portion of the electrical connector assembly 810 is shown in a loaded position (i.e., the electrical connector assembly 810 is ready to receive the end portion of the flexible medical guidewire assembly 102). The lower portion of the electrical connector assembly 810 is shown in a locked and engaged position (the electronics of the electrical connector assembly 810 are in electrical contact with the terminals of the flexible medical guidewire assembly 102). The connector channel 824 is formed as a complementary profile 826. The complementary profile 826 has a shape complementary to the outer profile of the end portion of the flexible medical guidewire assembly 102. The button 820 is configured to move (in series) an on-grip terminal including a first pole 828A (for use with a first terminal portion 409A) and a second pole 828B (for use with a core terminal portion 106A). The first pole 828A and the second pole 828B are spaced apart from each other.

[0174] According to such Figure 10A and Figure 10B In the implementation scheme depicted, each unique electrical connection can be configured with an independent path to ensure (full) electrical connection with each connector face (of the wire). Alternatively, a bias connection can be provided for the core element 106 to ensure that an electrical connection is only possible after other poles have made contact.

[0175] Figure 11A and Figure 11B Depicting Figure 1DA perspective view of an embodiment of the flexible medical guidewire assembly 102 (wherein such a diagram is shown). Figure 11A , Figure 11B and / or Figure 11C Some of the technical features described herein can be applied to, for example Figure 1A , Figure 1B and Figure 1C The implementation scheme described herein (if applicable). Figure 11C Depicting configurations that can be connected to Figure 11A and / or Figure 11B A side view of an embodiment of the electrical connector 810 of the flexible medical guidewire assembly 102.

[0176] For reference Figure 11A and Figure 11B In the embodiment depicted, the end portion (proximal end or user-accessible portion, etc.) of the flexible medical guidewire assembly 102 includes a flat radial end face 911. The flat radial end face 911 faces axially along an axial axis extending outward from the end portion of the flexible medical guidewire assembly 102. A first terminal portion 409A includes a first protrusion (axially extending post) extending axially from (away from) the flat radial end face 911 (i.e., extending from the sheath element 108). A second terminal portion 409B includes a second protrusion (axially extending post) extending axially from (away from) the flat radial end face 911 (i.e., extending from the sheath element 108). A third terminal portion 409N includes a third protrusion (axially extending post) extending axially from (away from) the flat radial end face 911 (extending from the sheath element 108). The first terminal portion 409A, the second terminal portion 409B, and the third terminal portion 409N are electrically connected to associated electrical sensor devices (such as... Figure 3 The electrical sensor devices 404A, etc., depicted herein are spaced apart from each other (preferably, equidistant from each other). The core terminal portion 106A extends axially from the core element 106 and is away from the flexible medical guidewire assembly 102 (in the same direction as the alignment of the terminal portions (409A, 409B, 409N)).

[0177] For reference Figure 11B In the embodiment depicted, the end portion (proximal portion) of the flexible medical guidewire assembly 102 includes a flat radial end face 911 (rear plane, end face, etc.) facing an axial axis extending from the end portion of the flexible medical guidewire assembly 102. A first terminal portion 409A includes a first flat end face terminal portion extending radially along the flat radial end face 911 (at least partially). A second terminal portion 409B includes a second flat end face terminal portion extending radially along the flat radial end face 911 (at least partially). A Nth terminal portion 409N includes a Nth flat end face terminal portion extending radially along the flat radial surface 911 (at least partially).

[0178] For reference Figure 11C In the implementation scheme described herein, the electrical connector assembly 810 is configured to connect with, as shown in the diagram... Figure 11A and / or Figure 11B The terminal portions (409A, 409B, 409N) of the implementation scheme described herein interact (electrically). For example... Figure 11A and / or Figure 11B As depicted, the terminal portions (409A, 409B, 409N) are positioned at a flat radial end face 911. The electrical connector assembly 810 includes axially extending wire connections 832 (spring-loaded conductive elements or rods), each wire connection having a corresponding spring member 833. Each corresponding spring member 833 is configured to bias the extension of the axially extending wire connection 832 outwards from the electrical connector assembly 810. Each corresponding spring member 833 is positioned within a connector channel 824 defined by the electrical connector assembly 810.

[0179] For reference Figure 11C In the embodiment depicted, button 820 is mounted externally to the housing of electrical connector assembly 810. Button 820 is configured to selectively lock onto (and selectively unlock from) the end portion (proximal end) of flexible medical guidewire assembly 102. It should be understood that, in some embodiments, flexible medical guidewire assembly 102 includes a conductive core terminal portion 106A, wherein the core element 106 is also conductive, etc. Once button 820 is activated (by a user or physician, etc.), button 820 selectively locks (securely connects) electrical connector 810 to the end portion of flexible medical guidewire assembly 102, with radially extending wire connections 832 making electrical contact with the terminal portions (409A, 409B, 409N, 106A, etc.). Spring member 818 (also known as compression spring) is positioned in electrical connector 810 and configured to bias connector conductor 822 (across the axial axis of flexible medical guidewire assembly 102) to core end portion 106A (once the end portion of flexible medical guidewire assembly 102 is inserted into connector channel 824 of electrical connector 810).

[0180] Figure 12A Depicting Figure 1D A perspective view of an embodiment of the flexible medical guidewire assembly 102 (wherein such a diagram is shown). Figure 12A , Figure 12B and / or Figure 12C Some of the technical features described herein can be applied to, for example Figure 1A , Figure 1B and Figure 1C The implementation scheme described herein (if applicable). Figure 12B and Figure 12C Depicting configurations that can be connected to Figure 12AA side view of an embodiment of the electrical connector 810 of the flexible medical guidewire assembly 102.

[0181] For reference Figure 12A The embodiment depicted includes a flexible medical guidewire assembly 102 comprising (preferably) a plurality of terminal portions (409A, 409B, 409N, 106A) positioned at a core terminal portion (proximal end portion or user-accessible portion) of the flexible medical guidewire assembly 102. According to a preferred embodiment, the plurality of terminal portions (409A, 409B, 409N, 106A) include electrical connections such as... Figure 3 The first terminal portion 409A of the first electrical sensor device 404A depicted herein. The second terminal portion 409B is electrically connected to another electrical sensor device (not depicted). The Nth terminal portion 409N is electrically connected to, as shown in the diagram. Figure 3 The Nth electrical sensor device 404N is depicted. A core terminal portion 106A is electrically connected to a core element 106. At least some of the plurality of terminal portions (409A, 409B, 409N) are mounted to the outer surface of the sheath element 108 (and extend axially along a portion thereof). At least some of the plurality of terminal portions (409A, 409B, 409N) extend along (at least partially) the radial extension direction of a flat radial end face 911 (of the flexible medical guidewire assembly 102). The flat radial end face 911 is positioned at the end portion (segment) of the flexible medical guidewire assembly 102. At least some of the plurality of terminal portions (409A, 409B, 409N) are spaced apart from each other (angularly spaced) along the outer surface of the sheath element 108.

[0182] For reference Figure 12A In the embodiment depicted, the core terminal portion 106A extends axially away from the end portion of the core element 106 from the end portion of the elastic medical guidewire assembly 102 (preferably). The core terminal portion 106A is formed (preferably) an elongated post (conductive post) having a keyed outer contour (such as a semi-circular outer contour). The core terminal portion 106A forms (preferably) an axially extending flat side at its outer end.

[0183] For reference Figure 12B In the implementation scheme described herein, the electrical connector assembly 810 is configured to connect with, as shown in the diagram... Figure 12AThe multiple terminal portions (409A, 409B, 409N, 106A) depicted herein are interfaced (electrical interfaces). A button 820 is mounted 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 multiple 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 keyed (corresponding keyed) terminal portion (preferably, the proximal end) of the flexible medical guidewire assembly 102, such as... Figure 12A The core terminal portion 106A, etc., is depicted in the diagram. A leaf spring 836 is positioned on the inner surface of the connector assembly 810 facing the connector channel 824 (keyed connector channel). The leaf spring 836 is configured to... Figure 12A Multiple terminal portions (409A, 409B, 409N, 106A) are biased toward a relatively robust electrical connection (and mechanical connection) between the multiple terminal portions (409A, 409B, 106A) and corresponding electrical contacts provided by the electrical connector assembly 810. Channel 824 (keyed connector channel) includes (preferably) a keying mating groove 838 (keying slot) configured to engage (slidably receive). Figure 12A The core terminal portion 106A. The electrical connector assembly 810 (assisted by the leaf spring 836) is configured to allow axial sliding interfaces between the multiple terminal portions (409A, 409B, 106A) and the electrical connector assembly 810.

[0184] For reference Figure 12C In the embodiment depicted, the electrical connector assembly 810 is configured to provide keyed in-line connections. This arrangement facilitates keyed alignment between multiple terminal portions (409A, 409B, 409N, 106A) (also referred to as proximal electrode terminals) spaced apart from each other. This arrangement reduces the risk of incorrect electrical connections. Connector terminals 840 of the electrical connector assembly 810 are located inside the connector channel 824 (keyed connector channel) and are configured to electrically connect to the multiple terminal portions (409A, 409B, 409N, 106A) once the end of the flexible medical guidewire assembly 102 is inserted into the connector channel 824 of the electrical connector assembly 810.

[0185] The following provides a further description of the embodiments, wherein any one or more of any technical feature (described in the detailed description, summary, and claims) may be combined with any other one or more of any technical features (described in the detailed description, summary, and claims). It should be understood that, unless otherwise stated, each claim in the claims section is an open-ended claim. Unless otherwise stated, relational terms used in these descriptions should be interpreted to include specific tolerances that will be recognized by those skilled in the art as providing equivalent functionality. For example, the term vertical is not necessarily limited to 90.0 degrees and may include variations thereof that will be understood by those skilled in the art as providing equivalent functionality for the purpose described for the relevant component or element. In the context of configuration, terms such as “about” and “substantially” generally refer to a position, location, or configuration of the relevant element that is precisely or sufficiently close to maintain the operability of the elements within the invention without substantially modifying the invention. Similarly, unless specifically explicit from their context, numerical values ​​should be interpreted to include certain tolerances of negligible importance that will be recognized by those skilled in the art as they do not substantially alter the operability of the invention. It should be understood that the description and / or drawings identify and describe embodiments of the device (expressly or inherently). The device may include any suitable combination and / or arrangement of technical features identified in the detailed description, as may be required and / or desired to suit a particular technical purpose and / or technical function. It should be understood that, where possible and suitable, any one or more technical features of the device may be combined with any other one or more technical features of the device (in any combination and / or arrangement). It should be understood that those skilled in the art will recognize that, even if not expressly stated above, the technical features of each embodiment may (where possible) be deployed in other embodiments. It should be understood that those skilled in the art will recognize that other options for the configuration of the components of the device will be possible to suit manufacturing requirements and still remain within the scope described in at least one or more claims. This written description provides embodiments including the best mode and also enables those skilled in the art to manufacture and use the embodiments. The scope of this disclosure may be defined by the claims. The written description and / or drawings help to understand the scope of the claims. It is believed that all key aspects of the disclosed subject matter have been provided in this document. It should be understood that, for the purposes of this document, the word “comprising” is equivalent to the word “including,” where both words are used to indicate an open list of components, parts, components, etc. The term “comprising” is synonymous with the terms “including,” “containing,” or “characterized in,” and is inclusive or open-ended, and does not exclude additional, unlisted elements or method steps. “Comprising” is an “open-ended” phrase and allows coverage of techniques employing additional, unlisted elements.When used in claims, the word "comprising" is a transitional verb (transitional term) that separates the preamble of the claim from the technical features of the invention. The foregoing outlines non-limiting embodiments (examples). Specific non-limiting embodiments are described (examples). It should be understood that the non-limiting embodiments are merely illustrative examples.

Claims

1. An apparatus comprising: A flexible medical guidewire assembly configured for insertion into a confined space defined by a living body, the flexible medical guidewire assembly including a radiofrequency transmitter supported at the distal end of the flexible medical guidewire assembly, the radiofrequency transmitter being configured to deliver 270 Vrms to 400 Vrms for tissue puncture; as well as A sensor assembly, which is securely supported by the flexible medical guidewire assembly in such a way that once the flexible medical guidewire assembly is inserted into and moved along the confined space defined by the living body, the sensor assembly and the flexible medical guidewire assembly are movable along the confined space defined by the living body. The flexible medical guidewire assembly includes a conductive core element and is electrically connected to the radio frequency transmitter. The core element is surrounded by an insulating sheath element, wherein the insulating sheath element defines a sheath inlet formed in a central region of the insulating sheath element, the sheath inlet having a polygonal geometric cross-sectional shape formed by the inner surface of the insulating sheath element. The flexible medical guidewire assembly further includes at least one wire extending through the sheath inlet along the length of the flexible medical guidewire assembly, the at least one wire having an outer diameter that varies along the longitudinal length of the flexible medical guidewire assembly, wherein the at least one wire is positioned at the apex of the polygonal geometric cross-sectional shape of the sheath inlet, and wherein the core element is centrally positioned within the sheath inlet. The sensor assembly is electrically connected to the proximal terminal portion of the flexible medical guidewire assembly via the at least one wire; and The sensor assembly and the at least one wire are electrically isolated from the core element by a core insulation layer positioned above the core element within the sheath inlet.

2. The device according to claim 1, wherein: The sensor assembly includes at least one electrode.

3. The device according to claim 1, wherein: The sensor assembly includes multiple electrodes.

4. The device according to claim 1, wherein: The radio frequency transmitter is configured to burn tissue.

5. The device according to claim 4, wherein: The flexible medical guidewire assembly includes a distal portion; and The radio frequency transmitter is mounted on the end portion.

6. The device according to claim 5, further comprising: A cutting edge, which is attached to the end portion and configured to cut tissue.

7. The device according to claim 1, wherein: The flexible medical guidewire assembly is configured to guide a medical device into the confined space defined by the living body once the flexible medical guidewire assembly is inserted into the confined space defined by the living body.

8. The device according to claim 1, wherein: The flexible medical guidewire assembly provides a guide for subsequent insertion of medical devices.

9. The device according to claim 1, wherein: The core element includes a hollow tube configured to receive and accommodate wires.

10. The device according to claim 1, wherein: The sensor assembly includes: Magnetic sensor device.

11. The device according to claim 1, wherein: The sensor assembly includes: Electrical sensor device.

12. The device according to claim 1, wherein: The sensor assembly includes: An electrical sensor device configured to transmit electrical signals.

13. The device according to claim 1, wherein: The flexible medical guidewire assembly includes wires extending along the length of the flexible medical guidewire assembly; and The wire is electrically connected to the sensor assembly; and The wire extends from the sensor assembly toward the end of the flexible medical guidewire assembly and terminates at a terminal contact located at the end of the flexible medical guidewire assembly.

14. The device according to claim 1, wherein: The end portion is positioned at the end of the end section of the core element and the sheath element; and The distal portion of the flexible medical guidewire assembly includes an electrode configured to deliver energy to a portion of tissue, and to puncture the portion of tissue in response to the application of energy to the tissue. and The electrode is electrically connected to the core element, which is configured to transfer and apply radio frequency energy from the generator to the electrode; and The core element is conductive.

15. The device according to claim 1, wherein: The flexible medical guidewire assembly includes a proximal end, a distal end, and an electrode located near the distal end; and The electrode is coupled to a conductive wire extending to the proximal end, the conductive wire being configured to transfer energy to the electrode, the electrode emitting the energy to the living tissue, and, in response to the application of energy, the electrode becoming sharp and piercing the tissue; and The sensor assembly includes a plurality of proximal electrodes spaced apart from each other and fixedly positioned along the longitudinal length of the flexible medical guidewire assembly; and Multiple terminal portions are positioned at the proximal end of the flexible medical guidewire assembly; and The plurality of terminal portions are correspondingly electrically coupled to the plurality of proximal electrodes; and The plurality of terminal portions are configured to be selectively electrically connected to and removed from the electrical connector assembly.

16. The device according to claim 1, wherein: The end portion is positioned at the end of the end section of the core element and the sheath element; and The distal portion of the flexible medical guidewire assembly includes a distal electrode; and The distal electrode is electrically connected to the core element; and The core element is conductive.

17. The apparatus according to claim 16, wherein: The proximal end of the core element is configured to be electrically connected to a wire, wherein the wire is configured to provide power to the distal electrode via the core element.

18. The apparatus according to claim 16, wherein: The distal electrode includes a radio frequency transmitter; and The radio frequency transmitter is configured to provide a certain amount of energy to puncture adjacent tissue of the living body once the flexible medical guidewire assembly is inserted into the confined space defined by the living body and once the distal electrode is activated.

19. The device according to claim 1, further comprising: A sensor interface system configured to interact with the sensor components; and The sensor interface system is also configured to exchange signals with the sensor components.

20. The apparatus of claim 19, further comprising: Signal measurement system; and The sensor interface system is also configured to be electrically connected to the signal measurement system.

21. The device according to claim 1, wherein: The sensor assembly includes multiple electrical sensor devices spaced apart from each other and fixedly positioned along the longitudinal length of the flexible medical guidewire assembly.

22. The device according to claim 1, wherein: The sensor assembly includes: The exposed portion of the wire is exposed on the outer surface of the flexible medical guidewire assembly; and The wire extends along the length of the flexible medical guidewire assembly; and The wire extends toward the end of the flexible medical guidewire assembly and terminates at a terminal contact located at the end of the flexible medical guidewire assembly.

23. The device according to claim 1, further comprising: Braided elements, the braided elements being positioned within the flexible medical guidewire assembly; and The braided element is elastic and flexible.

24. The device according to claim 1, wherein: The radio frequency transmitter is configured to provide a certain amount of energy to puncture tissue adjacent to the living body once the flexible medical guidewire assembly is inserted into the confined space defined by the living body and once the radio frequency transmitter is activated; and The sensor assembly includes multiple electrical sensor devices spaced apart from each other and fixedly positioned along the longitudinal length of the flexible medical guidewire assembly.

25. The device according to claim 1, wherein: The sensor assembly includes multiple electrical sensor devices spaced apart from each other and fixedly positioned along the longitudinal length of the flexible medical guidewire assembly; and Multiple terminal portions are positioned as the proximal ends of the flexible medical guidewire assembly; and The plurality of terminal portions are electrically coupled to a corresponding one of the plurality of electrical sensor devices; and The plurality of terminal portions are configured to be selectively electrically connected to and removed from the electrical connector assembly.

26. The device according to claim 1, wherein: The radio frequency transmitter is configured to provide a certain amount of energy to puncture adjacent tissue of the living body once the flexible medical guidewire assembly is inserted into the confined space defined by the living body and once the radio frequency transmitter is activated; and The sensor assembly includes multiple electrical sensor devices spaced apart from each other and fixedly positioned along the longitudinal length of the flexible medical guidewire assembly; and Multiple terminal portions are positioned as the proximal ends of the flexible medical guidewire assembly; and The plurality of terminal portions are electrically coupled to a corresponding one of the plurality of electrical sensor devices; and The plurality of terminal portions are configured to be selectively electrically connected to and removed from the electrical connector assembly.

27. The device according to claim 26, wherein: The radio frequency transmitter and the plurality of electrical sensor devices are electrically insulated from each other.

28. An apparatus comprising: An electrical connector assembly having connector terminals; and The connector terminals are configured to electrically connect to the terminal portion of the flexible medical guidewire assembly, and The flexible medical guidewire assembly is configured to be inserted into a confined space defined by a living body, and The flexible medical guidewire assembly includes a conductive core element and at least one wire extending along the length of the flexible medical guidewire assembly. The flexible medical guidewire assembly includes an insulating sheath element surrounding the core element, the insulating sheath element defining a sheath inlet formed in a central region of the insulating sheath element. The sheath inlet has a polygonal cross-sectional shape formed by the inner surface of the insulating sheath element. The at least one wire extends through the sheath inlet and is positioned at a apex of the polygonal cross-sectional shape. The core element is centrally positioned within the sheath inlet. The terminal portion is electrically connected to the sensor assembly via the at least one wire, and The sensor assembly and the at least one wire are supported by the flexible medical guidewire assembly in such a way that once the flexible medical guidewire assembly is inserted into and moved along the confined space defined by the living body, the sensor assembly and the flexible medical guidewire assembly are movable along the confined space defined by the living body; and The sensor assembly and the at least one wire are electrically isolated from the core element by a core insulation layer positioned above the core element within the sheath inlet.

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