Medical tubular assembly
Patent Information
- Application Number
- JP2024228392
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2020-10-19
- Filing Date
- 2024-12-25
- Publication Date
- 2025-03-07
Smart Images

Figure 2025031907000001_ABST
Abstract
Description
[Technical field]
[0001] The present disclosure relates to (but is not limited to) the technical field of medical tubular assemblies (and methods therefor). [Background technology]
[0002] Known medical devices are configured to facilitate medical procedures and to assist health care providers in diagnosing and / or treating medical conditions of medical patients. Summary of the Invention
[0003] It will be appreciated that there is a need to alleviate (at least in part) at least one problem associated with known (existing) medical tubular bodies (also referred to as existing technology). After much research and experimentation with known (existing) medical tubular bodies, a (at least partial) understanding of the problem and a solution thereto have been (at least partially) identified and are (at least partially) expressed as follows:
[0004] 1 and 2 show side cross-sectional views of an elongated medical catheter assembly 302. 1 and 2, the elongated medical catheter assembly 302 is configured to receive a signal transmitting device 800. The signal transmitting device 800 may be disposed or attached to a distal section of, for example, an elongated medical needle 802. For example, the signal transmitting device 800 may include a material (e.g., metal for electrical conduction, for a sensor, for a distal energy emitting device configured to selectively emit energy (e.g., radio frequency energy)) that facilitates the transmission of a signal toward a biological feature of the patient 700 to form a puncture through (or cut a portion of) the biological feature of the patient 700 during a medical procedure.
[0005] 1 and 2, the medical imaging system 902 is configured to generate (calculate, determine, etc.) medical images of the patient 700 and the signal transmission device 800. The medical imaging system 902 is also configured to display the (generated or calculated) medical images on a medical display device (known and not shown) to a physician during a medical procedure, such as a transseptal procedure, which may be performed by a cardiac electrophysiologist, etc. The transseptal procedure may include forming a transseptal puncture to access the left atrium of the patient 700's heart, primarily for ablation of atrial fibrillation. If the medical imaging system 902 may include, for example, a fluoroscopy system (configured to emit radiation energy therefrom), the patient and / or physician may be at risk of side effects associated with continued use of fluoroscopy (i.e., too much radiation emission) during the transseptal procedure.
[0006] 1 and 2, for example, adapting the elongated medical catheter assembly 302 may lead to the use of different types of medical imaging systems (potentially replacing fluoroscopy) for the medical imaging system 902, such as (but not limited to) echocardiography, electro-anatomical mapping (EAM) systems (which may not require the emission of radiation). In this case, an opportunity is provided to reduce (preferably eliminate) the need for fluoroscopy (which involves the emission of radiation), thereby reducing undesirable exposure to excess radiation (which may be associated with or emitted from certain types of medical imaging systems 902, such as fluoroscopy systems) while the medical catheter assembly 302 is positioned within the patient 700 (such as within the heart of the patient 700). For example, it may be desirable to have the elongated medical needle 802 detected by an electro-anatomical mapping system (a type of medical imaging system 902) either before, during, or after performing a transseptal puncture on the patient 700 (thus preventing the radiation risks mentioned above). In this case, the physician can visualize (via a display unit of the electroanatomical mapping system) the signal transmitting device 800 as a representative medical image (such as a dot, point, spot image, etc.) formed (placed) within a three-dimensionally generated volume (another medical image) representing a biological feature of the patient 700 (such as the right artery of the heart).
[0007] 1 and 2, unfortunately, the location of the signal transmitting device 800 may be displayed on the visual display unit after the signal transmitting device 800 is stored inside the medical catheter assembly 302 (the medical image may be unintentionally lost or hidden, or may not continue to be displayed in the visual display unit). In this situation, the medical catheter assembly 302 unintentionally hides (shields, blocks) the signal communication from the signal transmitting device 800 to (between) the signal transmitting device 900 of the medical imaging system 902. This undesirable situation may prevent or interfere with the formation of a desired medical image on the visual display unit of the medical imaging system 902 (i.e., while the signal transmitting device 800 is received in the medical catheter assembly 302). The medical catheter assembly 302 is configured to provide a signal insulating layer (signal blocking material) disposed on the signal transmitting device 800 disposed inside the medical catheter assembly 302. For example, the signal transmitting device 800 may need to remain inside the medical catheter assembly 302 during the drop-down portion of the medical procedure (such as when pulling the medical catheter assembly 302 from the superior vena cava (SVC) to the atrial septum of the patient's 700 heart). Unfortunately, the visual display unit (of the medical imaging system 902) is unable to provide the physician with a suitable medical image of the signal transmitting device 800, and unfortunately, the medical procedure is performed blind (by the physician). In particular, the medical imaging system 902 may be unable to see (detect the presence of) the signal transmitting device 800 moving along (and within) the interior of the medical catheter assembly 302.Furthermore, it will be appreciated that the medical imaging system 902 may not be able to provide a proper visual display of the medical image of the movement of the signal transmitting device 800 if the signal transmitting device 800 may extend slightly forward along the lumen 108 away from the exit of the distal tip 104 of the medical catheter assembly 302, which may be a rather nerve-wracking situation for the physician (i.e., operating under undesirable viewing conditions and possibly causing unintended (undesirable) damage to the patient 700). It will be appreciated that in the embodiment of FIG. 1, the signal transmitting / receiving device 900 can properly (reliably) receive the signal from the signal transmitting device 800. It will be appreciated that in the embodiment of FIG. 2, the signal transmitting / receiving device 900 cannot properly (reliably) receive the signal from the signal transmitting device 800.
[0008] With reference to the embodiment (implementation form) as shown in FIG. 1, the signal transmission device 800 extends from the exit of the medical dilator assembly 302 to such an extent that the signal transmission device 900 (of the medical imaging system 902) can properly detect the presence of the signal transmission device 800 and generate a suitable medical image thereof. For signal triangulation (i.e., to determine the location of the signal source), the signal transmission device 900 may include (at least three) spaced signal transmitters and receivers (901A, 901B, 901C), such as a series of at least three surface electrodes (or devices or materials capable of transmitting or receiving electrical signals) configured to be placed on the surface of the patient 700 (e.g., on the chest of the patient 700).
[0009] With reference to the embodiment (implementation form) as shown in FIG. 2, the signal transmitting device 800 is moved along (extending into or retracting from) the interior of the medical dilator assembly 302 to such an extent that the signal transmitting / receiving device 900 (a) cannot reliably detect the presence (location) of the signal transmitting device 800, and (b) cannot generate a medical image due to the inability to detect. For example, the spaced signal transmitting / receiving devices (901A, 901B, 901C) cannot successfully triangulate a reliable signal and cannot reliably determine the location of the signal. Successful triangulation requires that all of the spaced signal transmitting / receiving devices (901A, 901B, 901C) receive an incoming signal from the signal transmitting device 800. A failure of triangulation occurs when, in use, less than three spaced signal transmitting / receiving devices (901A, 901B, 901C) fail to receive any incoming signal from the signal transmitting device 800. In this case, the medical imaging system 902 cannot provide any adequate visual display of medical images of the movement of the signal transmitting device 800 while it remains within the lumen 108 and back from the distal tip 104 of the medical catheter assembly 302. It will be appreciated that this can be a rather nerve-wracking situation for the physician (operating without desirable vision can cause accidental injury to the patient 700).
[0010] 1 and 2, and in view of the above discussion, it may be desirable to at least partially provide a technical solution to improve the safety and / or positioning accuracy of the signal transmitting device 800 during a portion of a medical procedure (such as a transseptal puncture procedure), thereby assisting in the visualization of suitable medical images (via the medical imaging system 902) of the signal transmitting device 800 while the signal transmitting device 800 is disposed or located inside the medical catheter assembly 302 (preferably all of the time or at least most of the time).
[0011] To at least partially alleviate at least one problem associated with existing technology, an apparatus is provided (in accordance with a principal aspect). The apparatus is for use with a patient, a signal transmission device, and a signal transmission / reception device of a medical imaging system. The apparatus includes, but is not limited to, an elongated medical tubular assembly having a distal tip configured to be received within the patient. The elongated medical tubular assembly is configured to receive the signal transmission device at the distal tip. The distal tip is configured to at least partially improve transmission of a signal from the signal transmission device to the signal transmission / reception device of the medical imaging system.
[0012] To at least partially alleviate at least one problem associated with existing technology, an apparatus is provided (in accordance with a principal aspect). The apparatus is for use with a patient, a signal transmission device, and a signal transceiver device of a medical imaging system. The apparatus includes, but is not limited to, an elongated medical tubular assembly configured to be received within the patient (comprising an elongated medical tubular assembly). The elongated medical tubular assembly includes a signal release feature configured to at least partially improve transmission of a signal from a signal transmission device disposed within the elongated medical tubular assembly toward the signal transceiver device of the medical imaging system.
[0013] To at least partially alleviate at least one problem associated with existing technology, a method is provided (according to a principal aspect) for improving transmission of signals from a signal transmission device to a signal transmission / reception device of a medical imaging system while the signal transmission device is disposed within the patient. The method includes, but is not limited to, receiving within the patient an elongated medical tubular assembly having a distal tip. The method also includes receiving a signal transmission device at a distal tip of the elongated medical tubular assembly. The distal tip is configured to at least partially improve transmission of signals from the signal transmission device to the signal transmission / reception device of the medical imaging system.
[0014] Other aspects are specified in the claims. Other aspects and features of the non-limiting embodiments will become apparent to those skilled in the art upon review of the following detailed description of the non-limiting embodiments together with the accompanying drawings. This Summary is provided to introduce concepts in a simplified form and is further described in the Detailed Description below. This Summary is not intended to identify potentially important features or anticipated essential features of the disclosed subject matter, nor is it intended to describe each or every implementation of the disclosed embodiments of the disclosed subject matter. Many other novel advantages, features, and relationships will become apparent as the description proceeds. The following drawings and description more particularly exemplify exemplary embodiments.
[0015] Non-limiting embodiments may be more fully understood by reference to the following detailed description of non-limiting embodiments when taken in conjunction with the accompanying drawings. The drawings are not necessarily to scale and may be shown by phantom lines, schematic representations, and partial views. In some cases, details unnecessary for understanding the embodiments (and / or details that make it difficult to appreciate other details) may be omitted. Corresponding reference characters indicate corresponding components throughout the several views of the drawings. Elements in the several views are shown for simplicity and clarity and are not drawn to scale. The dimensions of some elements in the figures may be exaggerated relative to other elements to facilitate understanding of the various disclosed embodiments. In addition, common and well-understood elements useful in commercially feasible embodiments are often not shown so as not to limit the scope of the embodiments of the present disclosure. [Brief description of the drawings]
[0016] [Figure 1] FIG. 1 is a side cross-sectional view of an elongated medical catheter assembly. [Diagram 2] FIG. 1 is a side cross-sectional view of an elongated medical catheter assembly. [Diagram 3]1A and 1B are cross-sectional views of an embodiment (implementation) of an elongated medical tubular assembly. [Figure 4] FIG. 2 is a side view of an embodiment (implementation) of an elongated medical tubular assembly. [Diagram 5] 2 is a cross-sectional view of an embodiment (implementation) of the elongated medical tubular assembly of FIG. 1. [Figure 6] 6 is a schematic diagram of a display unit of a medical imaging system showing an image of the elongated medical tubular assembly of FIG. 5 . [Figure 7] 2 is a cross-sectional view of an embodiment (implementation) of the elongated medical tubular assembly of FIG. 1. [Figure 8] 8 is a schematic diagram of a display unit of a medical imaging system showing an image of the elongated medical tubular assembly of FIG. 7. [Figure 9] FIG. 2 is a side view of the elongated medical tubular assembly of FIG. 1 . [Figure 10] FIG. 2 is a side view of the elongated medical tubular assembly of FIG. 1 . [Figure 11] FIG. 2 is a side view of the elongated medical tubular assembly of FIG. 1 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] The following detailed description is merely exemplary and is not intended to limit the described embodiments or the application and uses of the described embodiments. When used, the word "exemplary" or "illustrative" means "serving as an example, instance, or illustration." Any implementation described as "exemplary" or "illustrative" should not necessarily be construed as preferred or advantageous over other implementations. All implementations described below are example implementations provided to enable one of ordinary skill in the art to make or use embodiments of the disclosure and are not intended to limit the scope of the disclosure. The scope of the disclosure is defined by the claims. As used herein, the terms "up," "down," "left," "rear," "right," "front," "vertical," "horizontal," and derivatives thereof, refer to the orientation of the example drawings. No one is intended to be bound by any theory, expressed or implied, in the preceding "Technical Field," "Background," "Summary," or the following detailed description. It should also be understood that the devices and processes illustrated in the accompanying drawings and described in the following specification are example embodiments, aspects, and / or concepts defined in the appended claims. Therefore, dimensions and other physical characteristics regarding the disclosed embodiments should not be considered limiting unless the claims expressly state otherwise. The phrase "at least one" should be understood to be equivalent to "one (a)". Aspects (examples, modifications, alterations, options, variations, embodiments, and any equivalents thereof) are described with respect to the drawings. It should be understood that the disclosure is limited to the subject matter provided by the claims, and that the disclosure is not limited to the specific aspects shown and described. It will be understood that the scope of meaning of a device being configured to be coupled to an item (i.e., connected to an item to interact with the item) should be interpreted as the device being configured to be coupled to the item either directly or indirectly. Thus, "configured to" may include the meaning of "either directly or indirectly" unless otherwise specified.
[0018] 3 and 4 show a cross-sectional view (FIG. 3) and a side view (FIG. 4) of an embodiment (implementation) of an elongated medical tubular assembly 102. As shown in FIG. Referring to the embodiment (implementation) as shown in FIG. 3, the elongated medical tubular assembly 102 is configured for use with a patient 700, a signal transmitting device 800, and a signal transmitting / receiving device 900 of a medical imaging system 902. The signal transmitting device 800 may preferably be placed or attached to the elongated medical needle 802. The elongated medical needle 802 is configured to be received (at least partially) within the patient 700. The signal transmitting device 800 may preferably be placed or attached to the distal tip 104 of the elongated medical needle 802, where the signal transmitting device 800 includes an energy emitter (an electrode or material capable of transmitting or receiving an electrical signal) configured to selectively emit energy (preferably radio frequency energy) toward a biological feature of the patient 700. The emission of energy (from the signal transmitting device 800) is used during a medical procedure, such as to form a puncture through (or sever a portion of) a biological feature of the patient 700. It will be appreciated that in the embodiment of Figure 3, the signal transmitting / receiving device 900 can adequately (reliably) receive signals from the signal transmitting device 800 (in sharp contrast to embodiments such as that shown in Figure 2).
[0019] With reference to an embodiment (implementation form) as shown in FIG. 3, the signal transmission device 800 may include, but is not limited to, a BAYLIS (trademark) NRG (registered trademark) transseptal needle radiofrequency puncture device manufactured by BAYLIS MEDICAL COMPANY (headquartered in Canada).
[0020] With reference to the embodiment (implementation) as shown in FIG. 3, the elongated medical tubular assembly 102 may preferably comprise a biocompatible material suitable (or compatible for medical use) for specific performance (dielectric strength, heat, electrical insulation, corrosion, water resistance, heat resistance, etc.) to comply with industrial and regulatory safety standards. For considerations in the selection of suitable materials, see the following publication: Plastics in Medical Devices: Properties, Requirements, and Applications; 2nd Edition; Author: Vinny R. Sastri; Hardcover ISBN: 9781455732012; Publication Date: November 21, 2013; Publisher: Amsterdam [Pays-Bas]: Elsevier / William Andrew,
[2014] .
[0021] With reference to the embodiment as shown in FIG. 3, the elongated medical tubular assembly 102 and / or the elongated medical needle 802 may, if desired, include a shape-memory material, which is configured such that after manipulation and / or deformation, the shape-memory material returns to the original shape set (before manipulation). Shape-memory materials (SMMs) are known and will not be described in further detail. A shape-memory material is configured to recover its original shape from a significant apparent plastic deformation in response to a particular stimulus being applied to the shape-memory material. This is known as the shape memory effect (SME). Once the shape-memory material is deformed in the presence of a force by the stimulus, superelasticity may be observed (in alloys).
[0022] Referring to the embodiment (implementation) as shown in FIG. 3, the elongated medical tubular assembly 102 is configured to be at least partially received within a patient 700. The elongated medical tubular assembly 102 is configured to receive a signal transmission device 800. The elongated medical tubular assembly 102 is also preferably configured to receive an elongated medical needle 802 to which the signal transmission device 800 is attached. The elongated medical tubular assembly 102 may include, for example, any type of elongated medical tube, medical catheter assembly, medical dilator assembly, medical sheath assembly, etc., and / or any equivalent thereof. The elongated medical tubular assembly 102 preferably has a distal tip 104 configured to be received within a patient 700. The elongated medical tubular assembly 102 is configured to receive a signal transmission device 800 at the distal tip 104. The elongated medical tubular assembly 102 is (preferably) configured to be received within the elongated medical tubular assembly 102, such as in the lumen 108, so that the signal transmitting device 800 may be positioned at the distal tip 104 or may be movable.
[0023] 3, the distal tip 104 is configured to at least partially improve (facilitate, facilitate) the transmission of signals from the signal transmitting device 800 to the signal transmitting / receiving device 900 (such as an electrode or material capable of transmitting or receiving an electrical signal) of the medical imaging system 902. Preferably, the distal tip 104 is configured to at least partially improve the transmission of signals between the signal transmitting device 800 and the signal transmitting / receiving device 900 of the medical imaging system 902.
[0024] With reference to the embodiment (implementation) as shown in FIG. 3, the elongate medical tubular assembly 102 (preferably) defines a lumen 108 extending from the distal tip 104 towards the proximal end 110 of the elongate medical tubular assembly 102. The lumen 108 is configured to receive a signal transmitting device 800 at the proximal end 110. The lumen 108 is configured to guide (limit) movement of the signal transmitting device 800 from the proximal end 110 towards the distal tip 104 (along a forward movement). The lumen 108 is configured to guide (limit) movement of the signal transmitting device 800 from the distal tip 104 back towards the proximal end 110 (along a rearward movement).
[0025] Referring to the embodiment as shown in FIG. 3, the elongate medical tubular assembly 102 defines spaced apart perforations (106A, 106B, 106C). The spaced apart perforations (106A, 106B, 106C) extend from an interior of the elongate medical tubular assembly 102 to an exterior of the elongate medical tubular assembly 102. The spaced apart perforations (106A, 106B, 106C) are configured to provide fluid communication between an interior of the elongate medical tubular assembly 102 and an exterior of the elongate medical tubular assembly 102. The distal tip 104 preferably defines spaced apart perforations (106A, 106B, 106C). The spaced perforations (106A, 106B, 106C) are a preferred embodiment of the signal-liberating feature 105. In general, the elongated medical tubular assembly 102 includes the signal-liberating feature 105. The signal-liberating feature 105 may include, but is not limited to, the spaced perforations (106A, 106B, 106C) and any equivalents thereof. It will be understood that other embodiments of the signal-liberating feature 105 are described below. The signal-liberating feature 105 is attached to or located with the elongated medical tubular assembly 102. The signal-liberating feature 105 is attached to or located at the distal tip 104 of the elongated medical tubular assembly 102. Preferably, the signal release feature 105 is configured to facilitate signal communication (signal transmission) between the signal transmitting device 800 and the signal transmitting / receiving device 900 of the medical imaging system 902 or facilitate a connection therebetween. The signal release feature 105 is configured to at least partially improve (not block) the transmission of signals from the signal transmitting device 800 to (between) the signal transmitting / receiving device 900 of the medical imaging system 902 while the signal transmitting device 800 remains disposed within (or moves along) the elongated medical tubular assembly 102. The signal transmission may include unidirectional and / or bidirectional signal transmission (either direct and / or indirect signal transmission).
[0026] 3, the lumen 108 is configured to receive the signal transmitting device 800, preferably such that the lumen 108, in use, guides movement of the signal transmitting device 800 towards the spaced apart perforations (106A, 106B, 106C) disposed at the distal tip 104. The spaced apart perforations (106A, 106B, 106C) are configured to at least partially improve (not block) signal transmission (signal communication) from the signal transmitting device 800 to (between) the signal transmitting device 900 of the medical imaging system 902 while the signal transmitting device 800 remains disposed within (or moves along) the lumen 108 at or adjacent to the spaced apart perforations (106A, 106B, 106C).
[0027] 3, a method for improving transmission of signals from a signal transmitting device 800 to a signal transmitting / receiving device 900 (of a medical imaging system 902) while the signal transmitting device 800 is disposed within a patient 700 is shown. The method includes receiving an elongated medical tubular assembly 102 having a distal tip 104 within the patient 700. The method also includes receiving (positioning, disposing, or moving) the signal transmitting device 800 at the distal tip 104 (of the elongated medical tubular assembly 102), the distal tip 104 being configured to at least partially improve transmission of signals from the signal transmitting device 800 to (between) the signal transmitting / receiving device 900 of the medical imaging system 902.
[0028] 3, a method of enhancing transmission of signals from a signal transmitting device 800 to (between) a signal transmitting / receiving device 900 (of a medical imaging system 902) while the signal transmitting device 800 is located within the elongated medical tubular assembly 102 is shown. The method includes receiving a distal tip 104 of the elongated medical tubular assembly 102 within a patient 700. The distal tip 104 defines spaced perforations (106A, 106B, 106C), i.e., provides a signal release feature 105. The elongated medical tubular assembly 102 defines a lumen 108 extending between the distal tip 104 and a proximal end 110 of the elongated medical dilator assembly 110. The lumen 108 is configured to receive the signal transmitting device 800, preferably such that the lumen 108, in use, receives the signal transmitting device 800 at the spaced perforations (106A, 106B, 106C) or at the signal release feature 105. The method also includes using the signal release feature 105 or the spaced perforations (106A, 106B, 106C) to at least partially improve signal transmission between the signal transmitting device 800 disposed within the lumen 108 and a signal transmitting / receiving device 900 of the medical imaging system 902 (from the signal transmitting device 800 to the signal transmitting / receiving device 900).
[0029] With reference to the embodiment (implementation) as shown in Figure 3, the elongated medical tubular assembly 102 has a sidewall body member configured to allow transmission of a signal (communication signal) from the signal transmitting device 800 to (between) the medical imaging system 902 (or between the signal transmitting device 800 and the medical imaging system 902). In sharp contrast to the catheter assembly 302 (shown in Figures 1 and 2), the catheter assembly 302 has a body configured to block (insulate, prevent, delay, attenuate) the transmission of a signal communication from the signal transmitting device 800 to (between) the medical imaging system 902. The medical imaging system 902 is configured to be in electrical communication (either wirelessly or wired) with the signal transmitting / receiving device 900.
[0030] With reference to the embodiment (implementation) as shown in FIG. 3, the medical imaging system 902 is configured to communicate (either wired or wirelessly, electrically) a communication signal (through the signal transmitting / receiving device 900) with a signal transmitting device 800 (such as an energy emitter or electrode of a medical needle) disposed within the catheter assembly 102 (while the catheter assembly 102 is disposed within the patient 700). The medical imaging system 902 may include an electroanatomical mapping system, a fluoroscopy system, or any equivalent thereof. According to a preferred embodiment where it may be desirable to avoid radiation altogether, the medical imaging system 902 may exclude a fluoroscopy system to avoid any undesired exposure of radiation to the patient and / or physician, etc. The medical imaging system 902 is configured to locate (through cooperation with the signal transmitting / receiving device 900) the spatial position of the signal transmitting device 800 disposed inside the patient 700. For example, the medical imaging system 902 may utilize a triangulation method (known and not described herein) or configuration configured to determine the spatial position of the signal transmission device 800. The triangulation method or configuration may include placing the signal transmission device 900 on the surface of the patient 700 (such as on the chest of the patient 700). More specifically, for triangulation of the signal provided by the signal transmission device 800, the signal transmission device 900 may include (at least three) spaced signal transceivers (901A, 901B, 901C), such as a series of at least three surface electrodes configured to be placed on the surface of the patient 700 (such as on the chest of the patient 700). When the signal transmitting device 800 (energy emitter or electrode) is disposed inside the elongated medical tubular assembly 102, the elongated medical tubular assembly 102 has sidewall members or locations configured to facilitate (enhance) signal transmission of signal communication from the signal transmitting device 800 (via the signal transmitting and receiving device 900) to (between) the medical imaging system 902. The elongated medical tubular assembly 102 has at least one sidewall portion configured to at least partially avoid complete blockage (signal isolation) of transmission of any signal communication from the signal transmitting device 800 (via the signal transmitting and receiving device 900) to (between) the medical imaging system 902.In this case, visualization (or "triangulation") of the signal transmission device 800 (in sharp contrast to embodiments such as those shown in Figures 1 and 2) is at least partially improved by the catheter assembly 102. Visualization of the signal transmission device 800 (by the medical imaging system 902) may be improved, at least in part, by modifying a section of the catheter assembly 102, such as the distal tip 104 of the catheter assembly 102.
[0031] 3, for example, according to a first option, the signal release feature 105 may include spaced perforations (106A, 106B, 106C) or windows positioned or disposed in a section of the elongated medical tubular assembly 102 (such as in the distal tip 104), which configuration may allow for improved signal communication between the signal transmitting / receiving device 900 (also referred to as a surface electrode) and the signal transmitting device 800 (such as the puncture device of the medical needle assembly). The spaced perforations (106A, 106B, 106C) are configured so as not to adversely interact with tissue of the patient 700, supported devices, etc.
[0032] With reference to the embodiment (implementation form) as shown in FIG. 3, for example, according to a second option, the signal release feature 105 (of the elongated medical tubular assembly 102) may comprise (at least in part) a signal enhancing material surrounded by a signal blocking material of the elongated medical tubular assembly 102, which configuration may allow for improved signal communication between the signal transmitting / receiving device 900 (also referred to as a surface electrode) and the signal transmitting device 800 (such as the puncture device of the medical needle assembly).
[0033] With reference to the embodiment (implementation form) as shown in FIG. 3, for example, according to a third option, the signal release feature 105 (of the elongated medical tubular assembly 102) may entirely comprise a signal enhancing material without comprising a signal blocking material, and this configuration may allow for improved signal communication between the signal transmitting / receiving device 900 (also referred to as a surface electrode, or an electrode capable of transmitting or receiving an electrical signal) and the signal transmitting device 800 (such as the puncture device of the medical needle assembly).
[0034] Referring to the embodiment (implementation form) as shown in FIG. 3, for example, according to a fourth option, the elongated medical tubular assembly 102 (referring to FIG. 7) may include at least one device (such as a distal electrode) attached to a portion of the elongated medical tubular assembly 102 (such as the distal tip 104).
[0035] 3, by utilizing the elongated medical tubular assembly 102, the signal transmitting device 800 may advantageously be less likely to disappear from a medical image (also called a medical map, generated by the medical imaging system 902) when the signal transmitting device 800 is moved along an interior portion or section of the elongated medical tubular assembly 102. In this manner, the signal transmitting device 800 may advantageously be visible to the medical imaging system 902 when the signal transmitting device 800 is moved along the interior of the elongated medical tubular assembly 102. The elongated medical tubular assembly 102 may improve visualization of the signal transmitting device 800 during a medical procedure, such as a transseptal puncture.
[0036] Referring to the embodiment (implementation) as shown in FIG. 3 , if a radiofrequency emitting medical needle, a transseptal sheath, and a transseptal dilator are required, the elongated medical tubular assembly 102 may include a transseptal dilator (it will be understood that the system may include a sheath, a dilator, and a puncture device, and the signal release feature 105 may also be located or fabricated in the dilator), and the elongated medical tubular assembly 102 may have the following technical features: (a) any usable length (approximately 67 centimeters, 85 centimeters, (b) an inner diameter (e.g., about 0.032 inches (0.8128 millimeters) or the like) configured to accommodate a guidewire assembly, radio frequency emission needle; (c) an outer diameter (e.g., about 8 French, about 8.5 French, etc.) configured to fit within a sheath assembly; (d) a perforated distal tip section of the elongated medical tubular assembly 102; (e) at least one distal device (e.g., an electrode, etc.) disposed on the distal tip section of the elongated medical tubular assembly 102; (f) a shaft made of high-density polyethylene (HDPE); and / or (g) a Luer type connection made of high-density polyethylene.
[0037] With reference to an embodiment (implementation) such as that shown in FIG. 3 , if a radiofrequency emitting medical needle, a transseptal sheath, and a transseptal dilator are required, the elongated medical tubular assembly 102 may include a transseptal dilator and may be configured with (a) any usable (desirable) length (e.g., about 67 centimeters, about 85 centimeters, etc.) and / or curve (e.g., a D0 type curve, a D1 type curve, etc.), (b) an inner diameter (e.g., about 0.035 inches (0.889 mm)) configured to accommodate the radiofrequency emitting medical wire, (c) a transseptal sheath (e.g., about 0.035 inches (0.889 mm)) and / or curve (e.g., a D0 type curve, a D1 type curve, etc.), (d) a diameter (e.g., about 0.035 inches (0.889 mm)) configured to accommodate the radiofrequency emitting medical wire, and (e.g., about 0.035 inches (0.889 mm)) configured to accommodate the radiofrequency emitting medical wire. It may have (d) a perforated tip section having an outer diameter (e.g., about 8.5 French) configured to fit within a transseptal sheath, (e) at least one distal device (electrode) attached to the distal tip section, (f) a high density polyethylene shaft and a metal tube (hypotube) terminating before the tip section, (g) radiopaque and / or echogenic material (e.g., having platinum bands, iridium bands, coils, etc.), and / or (h) a polycarbonate hub.
[0038] With reference to the embodiment shown in FIG. 3, when the elongated medical tubular assembly 102 is configured to include a steerable sheath (known and not shown), the elongated medical tubular assembly 102 may be made of low-density polyethylene (LDPE). The tubular assembly 102 may be made of a combination of low density polyethylene (LDPE) and high density polyethylene (HDPE). The LDPE may be located in a distal region (of the elongated medical tubular assembly 102) and the HDPE may be located in a proximal region (of the elongated medical tubular assembly 102) to improve and / or enhance maneuverability.
[0039] With reference to the embodiment (implementation) as shown in FIG. 4, the signal transmitting device 800 extends (retracts) into the interior of the elongated medical tubular assembly 102 to such an extent that the signal transmitting / receiving device 900 can still reliably detect the presence of the signal transmitting device 800 and generate medical images (of the elongated medical tubular assembly 102) with the assistance or support of the signal release feature 105 of the elongated medical tubular assembly 102. For example, the spaced signal transmitting / receiving devices (901A, 901B, 901C) can successfully triangulate a reliable signal emanating from the signal transmitting device 800 (because the signal release feature 105 or spaced perforations (106A, 106B, 106C) help facilitate such signal communication). In sharp contrast to FIG. 2, the spaced signal transmitting / receiving devices (901A, 901B, 901C) can reliably determine the location of the signal, as shown in FIG. 4. Successful triangulation requires that all of the spaced apart signal transceivers (901A, 901B, 901C) receive an incoming signal from (transmitted from) the signal transmitting device 800 as a result of the presence of the signal release feature 105. Successful triangulation occurs when fewer than three spaced apart signal transceivers (901A, 901B, 901C) properly receive any incoming signal from the signal transmitting device 800, in use, due to the presence of the signal release feature 105. In this case, the medical imaging system 902 can provide a suitable visual indication of the medical image of the location (e.g., movement) of the signal transmitting device 800 while the signal transmitting device 800 remains at least partially within the lumen 108 (of the elongated medical tubular assembly 102) and / or is positioned rearward from the distal tip 104 (of the elongated medical tubular assembly 102). In this case, it will be appreciated that the signal release feature 105 or spaced perforations (106A, 106B, 106C) aid (facilitate) signal communication (when in use) from the signal transmitting device 800 to the spaced signal transceivers (901A, 901B, 901C) of the medical imaging system 902, thus at least partially mitigating accidental damage to the patient 700. In this case, the physician is not operating out of sight (as in the case shown in FIG. 2).The signal release feature 105 (of the elongated medical tubular assembly 102) helps the spaced signal transmitters and receivers (901A, 901B, 901C) to successfully triangulate the location of the signal transmitting device 800, thereby enabling the medical imaging system 902 to provide a visual display of a medical image to the signal transmitting device 800.
[0040] 5 and 6 show a cross-sectional view (FIG. 5) of an embodiment (implementation) of the elongated medical tubular assembly 102 of FIG. 1 and a schematic diagram (FIG. 6) of a display unit of a medical imaging system 902 showing an image of the elongated medical tubular assembly 102 of FIG. 5.
[0041] With reference to the embodiment as shown in FIG. 5, the signal transmitting device 800 is disposed within the elongated medical tubular assembly 102. The signal transmitting device 800 is disposed proximate to the signal releasing feature 105, i.e., the spaced perforations (106A, 106B, 106C), at a location not affected by the signal releasing feature 105. In this case, the signal releasing feature 105 cannot assist in signal communication between the signal transmitting device 800 and the signal transmitting / receiving device 900 (i.e., the spaced signal transceivers (901A, 901B, 901C) of the medical imaging system 902 as shown in FIG. 3). In this case, the signal transmitting / receiving device 900 cannot receive any suitable signal communication from the signal transmitting device 800 without the assistance of the signal releasing feature 105.
[0042] With reference to the embodiment (implementation) as shown in FIG. 6, a medical image 600 (such as a three-dimensional map of the heart of the patient 700 of FIG. 3) is generated by a medical imaging system 902 (of FIG. 3). A medical image 610 of the signal transmitting device 800 may or may not be reliably detectable by the signal transmitting device 900 of the medical imaging system 902 (depending on the location of the signal transmitting device 800 within the elongated medical tubular assembly 102 relative to the signal release feature 105). The medical image 610 is shown in FIG. 6 only to show that this may be a possible location of the signal transmitting device 800 (if the device of the signal transmitting device 900 is actually able to receive signal communication from the signal transmitting device 800). It will be understood that in this case, the position or location of the signal transmitting device 800 relative to the elongated medical tubular assembly 102 is not known (but is shown for understanding). It should be noted that the medical image 600 of the biological feature of the patient 700 is shown in a tented state (i.e., the distal portion of the elongated medical tubular assembly 102 is pushing against the biological wall of the patient 700) even though the medical image of the signal transmitting device 800 has not been seen or identified by the medical imaging system 902. In summary, it may be desirable to provide a good configuration in certain situations (as shown in FIG. 6 ) so that the medical imaging system 902 can provide (display) a suitable medical image that may be more meaningful (useful) to a physician than the case shown in FIG.
[0043] 7 and 8 show a cross-sectional view (FIG. 7) of an embodiment (implementation) of the elongated medical tubular assembly 102 of FIG. 1, and a schematic diagram (FIG. 8) of a display unit of a medical imaging system 902 showing an image of the elongated medical tubular assembly 102 of FIG. 7.
[0044] With reference to the embodiment (implementation) as shown in FIG. 7, the output of a display system of a medical imaging system 902 is shown. The elongated medical tubular assembly 102 includes a distal device 112 (such as an electrode). The distal device 112 is located (attached) at the distal tip 104. The distal device 112 is disposed on an outer surface of the elongated medical tubular assembly 102. The distal device 112 is located (attached) at the distal tip 104 proximate to the exit of the lumen 108. The distal device 112 is spaced apart from the signal release feature 105 or spaced apart perforations (106A, 106B, 106C). The distal device 112 is configured to selectively emit a signal that is transmitted to the signal transmitting / receiving device 900 of the medical imaging system 902 of FIG. 3. The distal device 112 at least partially mitigates the cases shown in Figures 5 and 6 where the signal release feature 105 may not be able to assist (affect) signal communication from the signal transmitting device 800 of Figure 3 to the signal transmitting / receiving device 900. This configuration enables the medical imaging system 902 to provide improved medical images (as shown in Figure 8). In summary, the distal device 112 is positioned proximate to the distal tip 104. The distal electrode 112 is configured to provide information (such as the spatial position of the distal tip 104) to the medical imaging system 902 (preferably via the signal transmitting / receiving device 900).
[0045] With reference to the embodiment (implementation) as shown in FIG. 8, the output of the display system of the medical imaging system 902 of FIG. 3 is shown when the distal device 112 (as shown in FIG. 7) is utilized. A medical image 612 is associated with the distal device 112. The medical image 610 of the signal transmitting device 800 may or may not be visible on the display system of the medical imaging system 902 (depending, of course, on the position of the signal transmitting device 800 relative to the signal release feature 105). As shown in FIG. 8, it will be understood that the relative position between the signal transmitting device 800 and the signal release feature 105 is such that the signal release feature 105 allows signal communication between the signal transmitting device 800 and the medical imaging system 902, and thus, in this case, the medical image 610 is shown.
[0046] 9, 10 and 11 show side views of the elongated medical tubular assembly 102 of FIG. With reference to the embodiment (implementation) shown in FIG. 9 , the spaced perforations (106A, 106B, 106C) comprise spaced rectangular slits aligned along the longitudinal axis of the elongated medical tubular assembly 102 and are positioned equidistant from the exit of the elongated medical tubular assembly 102.
[0047] With reference to the embodiment (implementation) shown in FIG. 10, the spaced apart perforations (106A, 106B, 106C) comprise spaced apart rectangular slits aligned along the radial axis of the elongated medical tubular assembly 102.
[0048] With reference to the embodiment (implementation) shown in FIG. 11, the spaced apart perforations (106A, 106B, 106C) include spaced apart diamond-shaped openings that are aligned along the radial axis of the elongated medical tubular assembly 102. (Additional Note) As a preferred embodiment, the technical ideas that can be understood from the above embodiment will be described below. [Item 1] 1. An apparatus for use with a patient, the apparatus having a signal transmission device and a signal transmission / reception device of a medical imaging system, the apparatus comprising: the device comprises an elongate medical needle having a distal tip, the signal transmission device being disposed at the distal tip; The apparatus includes an elongated medical tubular assembly configured to be at least partially received within the patient; the elongated medical tubular assembly includes a signal release feature configured to at least partially improve transmission of a signal from the signal transmitting device disposed within the elongated medical tubular assembly to the signal transmitting and receiving device of the medical imaging system; the signal transmission device includes an energy emitter configured to transmit a signal and configured to selectively emit energy used to form a puncture in or ablate a portion of a biological feature of a patient; Device. [Item 2] the elongated medical tubular assembly having a distal tip, the distal tip configured to be at least partially received within the patient; the signal release feature is located at the distal tip; Item 1. The device according to item 1. [Item 3] the elongated medical tubular assembly defining a lumen extending from a distal tip toward a proximal end of the elongated medical tubular assembly; the lumen is configured to at least partially receive the signal transmitting device in the signal release feature in use. 3. The device according to item 1 or 2. [Item 4] the signal release feature comprises spaced apart perforations; 4. The device according to any one of items 1 to 3. [Item 5] the elongated medical tubular assembly includes a distal electrode configured to provide information to the medical imaging system; 5. Apparatus according to any one of items 1 to 4. [Item 6] a distal device disposed proximate to a distal tip of the elongated medical tubular assembly; the distal device is configured to provide information to the medical imaging system; 6. The device according to any one of items 1 to 5. [Item 7] The energy emitter is an electrode. 7. The device according to any one of items 1 to 6. [Item 8] the elongated medical tubular assembly comprises a medical catheter assembly, a medical dilator assembly, or a medical sheath assembly; 8. The device according to any one of items 1 to 7. [Item 9] the signal release feature comprises spaced apart perforations extending from the interior of the elongated medical tubular assembly to an exterior of the elongated medical tubular assembly; the spaced perforations are configured to provide fluid communication between the interior of the elongated medical tubular assembly and the exterior of the elongated medical tubular assembly. 9. Apparatus according to any one of items 1 to 8. [Item 10] the signal release feature comprises spaced apart perforations located at a distal tip of the elongated medical tubular assembly; 10. The device according to any one of items 1 to 9. [Item 11] the signal release feature including a sidewall body member configured to allow transmission of a signal communication from the signal transmission device to the medical imaging system; 11. Apparatus according to any one of items 1 to 10. [Item 12] the signal release feature comprises a signal enhancing material surrounded by a signal blocking material of the elongated medical tubular assembly. 12. Apparatus according to any one of items 1 to 11. [Item 13] the signal release feature comprises spaced apart perforations, the spaced apart perforations comprising spaced apart rectangular slits aligned along a radial axis of the elongated medical tubular assembly or diamond shaped slits aligned along the radial or longitudinal axis of the elongated medical tubular assembly; 13. The device according to any one of items 1 to 12.
[0049] The following is provided as a further description of the embodiment, in which any one or more of any technical features (described in the "Description of the Invention", "Summary of the Invention" and "Claims") may be combined with any one or more of any other technical features (described in the "Description of the Invention", "Summary of the Invention" and "Claims"). Each claim in the "Claims" is understood to be an open-ended claim unless otherwise specified. Unless otherwise specified, related words used in these specifications should be interpreted to include certain tolerances that a person skilled in the art would recognize as providing equivalent functions. As an example, the term vertical is not necessarily limited to 90.0 degrees, but may include variations thereof that a person skilled in the art would recognize as providing equivalent functions for the purpose of describing the relevant member or element. In the context of a configuration, terms such as "about" and "substantially" generally refer to a configuration, location, or configuration that is either strictly equivalent to or sufficiently close to the location, location, or configuration of the relevant element, maintaining the operability of the elements in the present disclosure and not substantially changing the present disclosure. Similarly, unless otherwise clear from the context, numerical values should be interpreted as including certain tolerances that a person skilled in the art would recognize as negligible in importance since they do not substantially change the operability of the present disclosure. It will be understood that the specification and / or drawings specify and describe (explicitly or inherently) embodiments of the device. The device may include any suitable combination and / or permutation of the technical features specified in the detailed description, as may be necessary and / or desired to meet a particular technical purpose and / or technical function. It will be understood that, where possible and preferred, any one or more of the technical features of the device may be combined (in any combination and / or permutation) with any other one or more of the technical features of the device. It will be understood that a person skilled in the art would recognize that the technical features of each embodiment may be deployed in other embodiments (where possible) even if not explicitly stated as above.It will be understood that a person skilled in the art would recognize that other options for the configuration of the device components are possible to meet manufacturing requirements and still remain within the scope of at least one of the claims. This specification provides embodiments, including the best mode, and also enables one skilled in the art to make and use the embodiments. The scope of patentability is defined by the claims. The written specification and / or drawings may be helpful in understanding the claims. It is believed that all material aspects of the disclosed subject matter are provided herein. In this specification, the word "includes" is understood to be equivalent to the word "comprising", i.e., equivalent in that both words are used to mean a non-limiting recitation of assemblies, components, parts, and the like. "Including", "containing", or "characterized". The term "comprising," which is synonymous with the term "by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Comprising (comprised of) is an "open-ended" phrase, allowing for coverage of the technology using additional, unrecited elements. When used in the claims, "comprising" is a transitive verb (transitional word) that separates the claim preamble from the technical features of the present disclosure. The foregoing has outlined non-limiting embodiments. The description herein has been made with respect to certain non-limiting embodiments. It is understood that the non-limiting embodiments are merely illustrative. [Explanation of symbols]
[0050] Elongated medical tubular assembly 102 Distal tip 104 Signal Release Feature 105 Spaced Perforations (106A, 106B, 106C) Lumens 108 Proximal end 110 Distal Device (Electrode) 112 Medical Dilator Assembly 302 700 patients Signal transmitting device 800 Slender medical needle 802 Signal transmitting / receiving device 900 Spaced signal transmitters and receivers (901A, 901B, 901C) Medical Imaging Systems 902
Claims
1. 1. An apparatus for use with a patient, the apparatus having a signal transmission device and a signal transmission / reception device of a medical imaging system, the apparatus comprising: the device comprises an elongate medical needle having a distal tip, the signal transmission device being disposed at the distal tip; The apparatus includes an elongated medical tubular assembly configured to be at least partially received within the patient; the elongated medical tubular assembly includes a signal release feature configured to at least partially improve transmission of a signal from the signal transmitting device disposed within the elongated medical tubular assembly to the signal transmitting and receiving device of the medical imaging system; the signal transmission device includes an energy emitter configured to transmit a signal and configured to selectively emit energy used to form a puncture in or ablate a portion of a biological feature of a patient; Device.
2. the elongated medical tubular assembly having a distal tip, the distal tip configured to be at least partially received within the patient; the signal release feature is located at the distal tip; 2. The apparatus of claim 1.
3. the elongated medical tubular assembly defining a lumen extending from a distal tip toward a proximal end of the elongated medical tubular assembly; the lumen is configured to at least partially receive the signal transmitting device in the signal release feature in use.
3. Apparatus according to claim 1 or 2.
4. the signal release feature includes spaced apart perforations; 4. Apparatus according to any one of claims 1 to 3.
5. the elongated medical tubular assembly includes a distal electrode configured to provide information to the medical imaging system; 5. Apparatus according to any one of claims 1 to 4.
6. a distal device disposed proximate to a distal tip of the elongated medical tubular assembly; the distal device is configured to provide information to the medical imaging system; 6. Apparatus according to any one of claims 1 to 5.
7. The energy emitter is an electrode.
7. Apparatus according to any one of claims 1 to 6.
8. the elongated medical tubular assembly comprises a medical catheter assembly, a medical dilator assembly, or a medical sheath assembly; 8. Apparatus according to any one of claims 1 to 7.
9. the signal release feature comprises spaced apart perforations extending from the interior of the elongated medical tubular assembly to an exterior of the elongated medical tubular assembly; the spaced perforations are configured to provide fluid communication between the interior of the elongated medical tubular assembly and the exterior of the elongated medical tubular assembly.
9. Apparatus according to any one of claims 1 to 8.
10. the signal release feature comprises spaced apart perforations located at a distal tip of the elongated medical tubular assembly; 10. Apparatus according to any one of claims 1 to 9.
11. the signal release feature including a sidewall body member configured to allow transmission of a signal communication from the signal transmission device to the medical imaging system; 11. Apparatus according to any one of claims 1 to 10.
12. the signal release feature comprises a signal enhancing material surrounded by a signal blocking material of the elongated medical tubular assembly.
12. Apparatus according to any one of claims 1 to 11.
13. the signal release feature comprises spaced apart perforations, the spaced apart perforations comprising spaced apart rectangular slits aligned along a radial axis of the elongated medical tubular assembly or diamond shaped slits aligned along the radial or longitudinal axis of the elongated medical tubular assembly; 13. Apparatus according to any one of claims 1 to 12.
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