Patent Application
20230143116
This document relates to the technical field of (and is not limited to): (A) medical assemblies having sensor devices (and method therefor); and/or (B) medical assemblies having sensor devices for use with an electro-anatomical mapping system (and method therefor); and/or (C) medical assemblies having sensor devices and an electro-anatomical mapping system (and method therefor).
Known electro-anatomic mapping (EAM) systems are configured to facilitate the mapping of the heart of a patient and/or for electrophysiology procedures, such as cardiac ablation. Cardiac ablation is a procedure that is used to scar small areas in the heart of a patient.
It will be appreciated that there exists a need to mitigate (at least in part) at least one problem associated with the existing (known) electro-anatomic mapping (EAM) systems and/or medical assemblies having sensor devices, (also called the existing technology). After much study of, and experimentation with, the existing technology, an understanding (at least in part) of the problem and its solution have been identified (at least in part) and are articulated (at least in part) as follows:
Electro-anatomic mapping (EAM) systems are configured to facilitate mapping and/or cardiac ablation. Cardiac ablation is a procedure to scar or destroy tissue in a heart that's allowing incorrect electrical signals to cause an abnormal heart rhythm, in which diagnostic catheters are threaded through blood vessels to the heart where the catheters are used to map the electrical signals of the heart. Utilization of EAM systems has been shown to reduce fluoroscopic exposure and radiation dose (to patients and/or surgeons, etc.), with less significant effects on procedural duration and success rates. Among the data provided by EAM systems are chamber reconstruction, tagging of important anatomical landmarks and ablation lesions, display of diagnostic and mapping catheters without using fluoroscopy, activation mapping, and voltage (or scar) mapping. EAM systems have specialized features, such as enhanced ability to map unsustained or hemodynamically unstable arrhythmias, ability to display diagnostic as well as mapping catheter positions, and wide compatibility with a variety of catheters. The EAM system may be configured to provide data usable for procedural success (activation mapping, substrate mapping, cardiac geometry), etc. While the EAM system may offer assistance during a procedure, their incorrect or inappropriate application may substantially hamper mapping efforts and procedural success, and should not replace careful interpretation of data and strict adherence to electrophysiologic principles.
Precise transseptal puncture (of the heart of the patient) may be an important factor to ensure accurate Left Atrium (LA) interventions. Electro-anatomic mapping allows the three-dimensional (3D) visualization of a catheter inserted into the heart during pulmonary vein isolation. It may be an advantage to provide at least one or more electrodes positioned on a sheath assembly usable for EAM mapping. It may be desirable to place at least one electrode at a tip portion of a dilator assembly and a combination of sheath electrodes that may be utilized for improved precision transseptal puncture.
For instance, a dilator assembly (a primary medical assembly) may be inserted into a sheath assembly (a secondary medical assembly). The dilator assembly may follow (travel) the same direction in which the sheath assembly is pointed (aligned). For instance, a single dilator electrode, positioned at a dilator tip of the dilator assembly, may protrude from a distal opening of the sheath assembly. The single dilator electrode may be treated as an extension of the sheath electrodes (spaced-apart sensors) of the sheath assembly.
In this manner, the dilator assembly and sheath assembly, as detected or seen by the EAM system, may be treated as, effectively, a single medical assembly by the EAM system. This arrangement may provide improved versatile tracking options for the medical assemblies (such as a combination of a dilator assembly and a sheath assembly) when using the EAM system. It will be appreciated that the EAM system may include equivalent systems, such as a dielectric imaging system, or any type of imaging system, etc.
To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) an apparatus. The apparatus includes and is not limited to (comprises) a primary elongated medical assembly configured to be positioned in, and movable along, a patient. The primary elongated medical assembly has a primary sensor device (mounted thereto). The primary elongated medical assembly is configured to be utilized with a secondary elongated medical assembly configured to be positioned in, and movable along, the patient (in which the secondary elongated medical assembly has a secondary sensor device). In accordance with a preferred embodiment, the secondary elongated medical assembly (such as a dilator) is configured to be movable or deliverable within (along) a lumen defined along the primary elongated medical assembly (such as a sheath), and for this case the combination of the primary elongated medical assembly and the secondary elongated medical assembly cooperate (fit, integrate) with each other and a single medical assembly (such as, and not limited to, a combination of a dilator assembly and a sheath assembly, etc.). The primary elongated medical assembly is configured to be movable relative to the secondary elongated medical assembly (this is done in such a way that the primary sensor device and the secondary sensor device are movable relative to each other, that is once the primary elongated medical assembly and the secondary elongated medical assembly, in use, are positioned in, and are movable along, the patient).
To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) an apparatus. The apparatus includes and is not limited to (comprises) a primary elongated medical assembly configured to be positioned in, and movable along, a patient. A secondary elongated medical assembly is configured to be positioned in, and movable along, the patient. The primary elongated medical assembly has a primary sensor device (mounted thereto). The secondary elongated medical assembly has a secondary sensor device (mounted thereto). The primary elongated medical assembly and the secondary elongated medical assembly are each configured to be movable relative to each other (this is done in such a way that the primary sensor device and the secondary sensor device are movable relative to each other, that is once the primary elongated medical assembly and the secondary elongated medical assembly, in use, are positioned in, and are movable along, the patient). It will be appreciated that the term “movable relative to each other” includes, for at least at some cases, one assembly that is movable while the other assembly remains stationary, vice versa, or both assemblies are movable at rates of movement (such as speeds) relative to each other.
To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) an apparatus. The apparatus includes and is not limited to (comprises) an electro-anatomical mapping system configured to emanate (transmit) an electromagnetic-transmission signal. A primary elongated medical assembly is configured to be positioned in, and movable along, a patient. A secondary elongated medical assembly is configured to be positioned in, and movable along, the patient. The primary elongated medical assembly has a primary sensor device (mounted thereto). The secondary elongated medical assembly has a secondary sensor device (mounted thereto). The primary elongated medical assembly and the secondary elongated medical assembly are each configured to be movable relative to each other (this is done in such a way that the primary sensor device and the secondary sensor device are movable relative to each other, that is once the primary elongated medical assembly and the secondary elongated medical assembly, in use, are positioned in, and are movable along, the patient). The primary sensor device is also configured to receive the electromagnetic-transmission signal emanating from an electro-anatomical mapping system (once the primary elongated medical assembly, in use, is positioned in, and is movable along, the patient). The primary sensor device is also configured to transmit a primary detected signal back to the electro-anatomical mapping system (the electro-anatomical mapping system is also configured to receive the primary detected signal from the primary sensor device). The secondary sensor device is also configured to receive the electromagnetic-transmission signal emanating from the electro-anatomical mapping system (once the secondary elongated medical assembly, in use, is positioned in, and is movable along, the patient). The secondary sensor device is also configured to transmit a secondary detected signal back to the electro-anatomical mapping system (the electro-anatomical mapping system is also configured to receive the secondary detected signal from the secondary sensor device).
To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) a method. The method is for utilizing an electro-anatomical mapping system configured to emanate (transmit) an electromagnetic-transmission signal. The method includes and is not limited to (comprises) operational steps (A) to (G), which are identified in no particular order or preferred order of operations. A first operation (A) includes positioning and moving a primary elongated medical assembly in, and along, a patient, in which the primary elongated medical assembly has a primary sensor device (mounted thereto). A second operation (B) includes positioning and moving a secondary elongated medical assembly in, and along, the patient, in which the secondary elongated medical assembly has a secondary sensor device (mounted thereto). A third operation (C) includes moving the primary elongated medical assembly and the secondary elongated medical assembly relative to each other in such a way that the primary sensor device and the secondary sensor device are movable relative to each other, once the primary elongated medical assembly and the secondary elongated medical assembly, in use, are positioned in, and are movable along, the patient. A fourth operation (D) includes utilizing the primary sensor device to receive the electromagnetic-transmission signal emanating from an electro-anatomical mapping system, once the primary elongated medical assembly, in use, is positioned in, and is movable along, the patient. A fifth operation (E) includes utilizing the primary sensor device to transmit a primary detected signal back to the electro-anatomical mapping system, in which the electro-anatomical mapping system is configured to receive the primary detected signal from the primary sensor device. A sixth operation (F) includes utilizing the secondary sensor device to receive the electromagnetic-transmission signal emanating from the electro-anatomical mapping system, once the secondary elongated medical assembly, in use, is positioned in, and is movable along, the patient. A seventh operation (G) includes utilizing the secondary sensor device to transmit a secondary detected signal back to the electro-anatomical mapping system, in which the electro-anatomical mapping system is configured to receive the secondary detected signal from the secondary sensor device.
Other aspects are identified in the claims. Other aspects and features of the non-limiting embodiments may now become apparent to those skilled in the art upon review of the following detailed description of the non-limiting embodiments with the accompanying drawings. This Summary is provided to introduce concepts in simplified form that are further described below in the Detailed Description. This Summary is not intended to identify potentially key features or possible essential features of the disclosed subject matter, and is not intended to describe each disclosed embodiment or every implementation of the disclosed subject matter. Many other novel advantages, features, and relationships will become apparent as this description proceeds. The figures and the description that follow more particularly exemplify illustrative embodiments.
The non-limiting embodiments may be more fully appreciated by reference to the following detailed description of the non-limiting embodiments when taken in conjunction with the accompanying drawings, in which:
The drawings are not necessarily to scale and may be illustrated by phantom lines, diagrammatic representations and fragmentary views. In certain instances, details unnecessary for an understanding of the embodiments (and/or details that render other details difficult to perceive) may have been omitted. Corresponding reference characters indicate corresponding components throughout the several figures of the drawings. Elements in the several figures are illustrated for simplicity and clarity and have not been drawn to scale. The dimensions of some of the elements in the figures may be emphasized relative to other elements for facilitating an understanding of the various disclosed embodiments. In addition, common, and well-understood, elements that are useful in commercially feasible embodiments are often not depicted to provide a less obstructed view of the embodiments of the present disclosure.
The following detailed description is merely exemplary and is not intended to limit the described embodiments or the application and uses of the described embodiments. As used, the word “exemplary” or “illustrative” means “serving as an example, instance, or illustration.” Any implementation described as “exemplary” or “illustrative” is not necessarily to be construed as preferred or advantageous over other implementations. All of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the 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. For the description, the terms “upper,” “lower,” “left,” “rear,” “right,” “front,” “vertical,” “horizontal,” and derivatives thereof shall relate to the examples as oriented in the drawings. There is no intention to be bound by any expressed or implied theory in the preceding Technical Field, Background, Summary or the following detailed description. It is also to be understood that the devices and processes illustrated in the attached drawings, and described in the following specification, are exemplary embodiments (examples), aspects and/or concepts defined in the appended claims. Hence, dimensions and other physical characteristics relating to the embodiments disclosed are not to be considered as limiting, unless the claims expressly state otherwise. It is understood that the phrase “at least one” is equivalent to “a”. The aspects (examples, alterations, modifications, options, variations, embodiments and any equivalent thereof) are described regarding 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 particular aspects depicted and described. It will be appreciated that the scope of the meaning of a device configured to be coupled to an item (that is, to be connected to, to interact with the item, etc.) is to be interpreted as the device being configured to be coupled to the item, either directly or indirectly. Therefore, “configured to” may include the meaning “either directly or indirectly” unless specifically stated otherwise.
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The following is offered as further description of the embodiments, in which any one or more of any technical feature (described in the detailed description, the summary and the claims) may be combinable with any other one or more of any technical feature (described in the detailed description, the summary and the claims). It is understood that each claim in the claims section is an open ended claim unless stated otherwise. Unless otherwise specified, relational terms used in these specifications should be construed to include certain tolerances that the person skilled in the art would recognize as providing equivalent functionality. By way of example, the term perpendicular is not necessarily limited to 90.0 degrees, and may include a variation thereof that the person skilled in the art would recognize as providing equivalent functionality for the purposes described for the relevant member or element. Terms such as “about” and “substantially”, in the context of configuration, relate generally to disposition, location, or configuration that are either exact or sufficiently close to the location, disposition, or configuration of the relevant element to preserve operability of the element within the disclosure which does not materially modify the disclosure. Similarly, unless specifically made clear from its context, numerical values should be construed to include certain tolerances that the person skilled in the art would recognize as having negligible importance as they do not materially change the operability of the disclosure. It will be appreciated that the description and/or drawings identify and describe embodiments of the apparatus (either explicitly or inherently). The apparatus may include any suitable combination and/or permutation of the technical features as identified in the detailed description, as may be required and/or desired to suit a particular technical purpose and/or technical function. It will be appreciated that, where possible and suitable, any one or more of the technical features of the apparatus may be combined with any other one or more of the technical features of the apparatus (in any combination and/or permutation). It will be appreciated that persons skilled in the art would know that the technical features of each embodiment may be deployed (where possible) in other embodiments even if not expressly stated as such above. It will be appreciated that persons skilled in the art would know that other options may be possible for the configuration of the components of the apparatus to adjust to manufacturing requirements and still remain within the scope as described in at least one or more of the claims. This written description provides embodiments, including the best mode, and also enables the person skilled in the art to make and use the embodiments. The patentable scope may be defined by the claims. The written description and/or drawings may help to understand the scope of the claims. It is believed that all the crucial aspects of the disclosed subject matter have been provided in this document. It is understood, for this document, that the word “includes” is equivalent to the word “comprising” in that both words are used to signify an open-ended listing of assemblies, components, parts, etc. The term “comprising”, which is synonymous with the terms “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Comprising (comprised of) is an “open” phrase and allows coverage of technologies that employ additional, unrecited elements. When used in a claim, the word “comprising” is the transitory verb (transitional term) that separates the preamble of the claim from the technical features of the disclosure. The foregoing has outlined the non-limiting embodiments (examples). The description is made for particular non-limiting embodiments (examples). It is understood that the non-limiting embodiments are merely illustrative as examples.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2021/052907 | 4/7/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63007703 | Apr 2020 | US |
