Systems and methods for intra-sternal positioning of a device

Abstract

An implantable electrical apparatus including a lead configured to be disposed in an anterior mediastinum of a patient. The lead includes at least one sensor configured to sense a bio-signal within the anterior mediastinum. The implantable electrical apparatus includes an electrical device disposed on an anterior side of a sternum of the patient. The electrical device is coupled to the lead via at least one opening defined in the sternum. The electrical device is configured to receive, from the lead, data associated with the bio-signal and at least one of determine a health status of the patient or generate energy associated with cardiac treatment for delivery via the lead.

Description

Docket No. NHAN-006 / 01WO 351645-2022SYSTEMS AND METHODS FOR INTRA-STERNAL POSITIONING OF A DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 719,227, filed November 12, 2024, entitled “Systems and Methods for Intra-Sternal Positioning of a Device,” the disclosure of which is incorporated herein by reference in its entirety.BACKGROUND

[0002] The embodiments described herein relate generally to implantable medical devices and more particularly, to systems and methods of intra-sternal positioning of a diagnostic and / or treatment device configured to make diagnostic and / or treatment decisions based on, for example, bio-signals in the anterior mediastinum.

[0003] The anterior mediastinum, located between the lungs and in front of the heart, is directly behind the sternum. Access to the anterior mediastinum can be desirable for diagnostic and / or for therapeutic purposes. For example, medical devices can access the anterior mediastinum to take measurements associated with the heart, lungs, and other patient anatomy for diagnostic purposes and for monitoring. Devices can also access the heart to provide cardiac treatment.

[0004] However, as the anterior mediastinum is located behind the sternum, accessing the anterior mediastinum can require invasive procedures which can result in prolonged hospitalization, extended recovery times, potential complications, and / or increased morbidity. Current methods of accessing the mediastinum include mediastinoscopy which enables incisions and the insertion of endoscopic tools. However, such methods do not allow for visualization of the mediastinum directly and can be limited in mediastinum access based on the incision site of the mediastinoscopy. Thus, there is a need for minimally invasive access of the anterior mediastinum that allows for flexibility in device placement.SUMMARY

[0005] In some embodiments, an implantable electrical system includes a lead configured to be disposed in an anterior mediastinum of a patient. The lead includes at least one sensor configured to sense a bio-signal within the anterior mediastinum. The system includes an electrical device disposed on an anterior side of a sternum of the patient. The electrical device is coupled to the lead via at least one opening defined in the sternum. The electrical device isDocket No. NHAN-006 / 01WO 351645-2022configured to receive, from the lead, data associated with the bio-signal and at least one of determine a health status of the patient or generate energy associated with cardiac treatment for delivery via the lead.

[0006] In some embodiments, an implantable electrical system includes a lead configured to be disposed in an anterior mediastinum of a patient. The lead includes at least one sensor configured to sense a bio-signal within the anterior mediastinum. The system includes an electrical device configured to be disposed on an anterior side of a sternum of the patient. Further, the system includes an interface configured to extend through the sternum. The interface can be configured to electrically couple the lead and the electrical device. The electrical device can be configured to receive, from the lead via the interface, data associated with the bio-signal and at least one of determine a health status of the patient or generate energy associated with cardiac treatment for delivery via the lead.

[0007] In some embodiments, a method includes forming at least one opening in a sternum of a patient. The at least one opening allows access to an anterior mediastinum of the patient. The method includes inserting a lead through the at least one opening to a desired position in the anterior mediastinum. The lead includes at least one sensor configured to sense a bio-signal within the anterior mediastinum. The method includes disposing an electrical device on an anterior wall of the sternum and / or in a subcutaneous pocket. The electrical device is coupled to the lead via at least one opening defined in the sternum. The electrical device is configured to receive, from the lead, data associated with the bio-signal and at least one of determine a health status of the patient or generate energy associated with cardiac treatment for delivery via the lead.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1 schematically depicts an intra-stemal diagnostic / treatment system, according to an embodiment.

[0009] FIG. 2 schematically depicts an intra-sternal diagnostic / treatment system engaging the anterior mediastinum, according to an embodiment.

[0010] FIG. 3 schematically depicts an intra-stemal diagnostic / treatment system including an electrical device disposed on the sternum engaging the anterior mediastinum, according to an embodiment.Docket No. NHAN-006 / 01WO 351645-2022

[0011] FIG. 4 depicts a perspective view of an electrical device included in an intra-sternal diagnostic / treatment, according to an embodiment.

[0012] FIG. 5 depicts an electrical device of an intra-sternal diagnostic / treatment disposed on an anterior wall of a sternum of a patient, according to an embodiment.

[0013] FIG. 6 depicts an intra-sternal diagnostic / treatment system implanted in a patient, according to an embodiment.

[0014] FIG. 7 is a flow chart depicting a method for implanting an intra-sternal diagnostic / treatment system, according to an embodiment.DETAILED DESCRIPTION

[0015] The embodiments described herein relate generally to systems and / or methods for intra-sternal delivery of a lead of an implantable electrical system into the anterior mediastinum of a patient. In some embodiments, the lead is configured to sense a bio-signal within the anterior mediastinum and / or to deliver cardiac treatment to the heart of the patient. For example, the bio-signal can include a cardiac signal (e.g., cardiac electrical signal, cardiac mechanical signal, etc.), a respiratory signal, and / or any other signal on or in the body. The implantable electrical system can include an electrical device located outside of the anterior mediastinum configured to receive data associated with the bio-signal and determine a health status of the patient and / or generate energy associated with cardiac treatment.

[0016] In some embodiments, the implantable electrical system can be or include an implantable cardioverter defibrillator (ICD), a pacemaker, a cardiac resynchronization therapy (CRT) device, cardiac loop recorder, cardiac monitor, pulmonary monitor, hemodynamic monitor, vital parameters monitor, and / or the like. An electrical device of the implantable electrical system can be coupled to the anterior wall of the sternum or can be in a subcutaneous pocket on the chest of the patient. In some embodiments, the electrical device may be coupled to the sternum with one or more fastener. The electrical device is coupled to a lead that is configured to access or other be disposed in the anterior mediastinum via or through one or more opening in the sternum. The one or more opening can allow for visualization of the anterior mediastinum and / or the heart prior to inserting the lead and for access to the anterior mediastinum. The lead can have any suitable shape, size, and / or configuration that allows for access to and / or insertion into the anterior mediastinum via the one or more opening.Docket No. NHAN-006 / 01WO 351645-2022

[0017] The lead can include at least one of a sensor, shock coils, and / or electrodes. The shock coils and / or the electrodes can be used to provide cardiac therapy to the heart of the patient. The therapy can include delivering electrical energy to the heart of the patient. The electrical energy can include relatively high-power energy for shock therapy (e.g., defibrillation therapy) and / or relatively low-power energy for cardiac pacing. In some embodiments, the implantable electrical system can include additional components for supporting the sensing of bio-signals and / or generating cardiac therapy, such as a generator, battery, and / or the like. In some embodiments, the implantable electrical system can be configured to determine, detect, and / or measure additional characteristics such as movement, body position, blood oxygen saturation, and / or the like.

[0018] In some embodiments, the systems and methods described herein can be used for cardiac pacing, treating tachycardia, detecting arrhythmia, monitoring congestive heart failure patients, pulmonary monitoring (e.g., for chronic obstructive pulmonary disease, sleep apnea, etc.), hemodynamic monitoring, monitoring in a hospital (e.g., intensive care unit (ICU), clinic, respiratory intensive care unit (RICU), critical care unit (CCU), surgical intensive care unit (SICU), etc.), emergency monitoring, post-surgical monitoring, nursing patient monitoring, vital parameter monitoring, and / or the like.

[0019] The terminology used herein is for the purpose of describing particular embodiments, implementations, and / or concepts (including any feature(s) or aspect(s) thereof) and is not intended to be limiting. Unless defined otherwise, technical and / or scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Any explanation or discussion of or using particular terms is intended to provide context and to facilitate understanding and is not necessarily intended to replace or supersede commonly used or known definitions understood by one skilled in the art unless explicitly stated otherwise. Moreover, various terms may be used to describe similar or substantially the same embodiments, implementations, and / or concepts (including any feature(s) or aspect(s) thereof) and thus, the use of particular term is not intended to be limiting and / or to the exclusion of other terms unless the terms are mutually exclusive, or the context clearly states otherwise.

[0020] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. With respect to the use of singular and / or plural terms herein, those having skill in the art can translate from the singular to the plurality and / or vice versa as is appropriate for the context and / or application. Furthermore, any reference herein to a singular component, feature, aspect, etc. is not intended to imply theDocket No. NHAN-006 / 01WO 351645-2022exclusion of more than one such component, feature, aspect, etc. (and / or vice versa) unless expressly stated otherwise. The various singular / plural permutations may be expressly set forth herein for sake of clarity.

[0021] In general, terms used herein and in the appended claims are intended as “open” terms unless expressly stated otherwise. For example, the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” etc. Similarly, the term “comprising” may specify the presence of stated features, elements, components, integers (or fractions thereof), steps, operations, and / or the like but does not preclude the presence or addition of one or more other features, elements, components, integers (or fractions thereof), steps, operations, elements, components, and / or groups thereof, and / or the like unless such combinations are otherwise mutually exclusive.

[0022] As used herein the term “and / or” includes any and all combinations of one or more of the associated listed items. It should be understood that any suitable disjunctive word and / or phrase presenting two or more alternative terms, whether in the written description or claims, contemplate the possibilities of including one of the terms, either of the terms, or both / all of the terms. For example, the phrase “A and / or B” will be understood to include the possibilities of “A” alone, “B” alone, or a combination of “A and B.”

[0023] All ranges described herein include each individual member or value and are intended to encompass any and all possible subranges and / or combinations of subranges thereof unless expressly stated otherwise. Any listed range should be recognized as sufficiently describing and enabling the same range being broken down into at least equal subparts unless expressly stated otherwise.

[0024] As used herein, the terms “about,” “approximately,” and / or “substantially” when used in connection with stated value(s) and / or geometric structure(s) or relationship(s) is intended to convey that the value or characteristic so defined is nominally the value stated or characteristic described. In some instances, the terms “about,” “approximately,” and / or “substantially” can generally mean and / or can generally contemplate a value or characteristic stated within a desirable tolerance (e.g., plus or minus 10% of the value or characteristic stated). For example, a value of about 0.01 can include 0.009 and 0.011, a value of about 0.5 can include 0.45 and 0.55, a value of about 10 can include 9 to 11, and a value of about 1000 can include 900 to 1100. Similarly, a first surface may be described as being substantially parallel to a second surface when the surfaces are nominally parallel. While a value, structure, and / orDocket No. NHAN-006 / 01WO 351645-2022relationship stated may be desirable, it should be understood that some variance may occur as a result of, for example, manufacturing tolerances or other practical considerations (such as, for example, the pressure or force applied through a portion of a device, conduit, lumen, etc.). Accordingly, the terms “about,” “approximately,” and / or “substantially” can be used herein to account for such tolerances and / or considerations.

[0025] As used herein, the words “proximal” and “distal” refer to the direction closer to and away from, respectively, a user who would place the device into contact with a patient. The words “proximal” or “distal” can be relative terms and do not necessarily refer to universally fixed positions or directions. Thus, for example, the end or end portion of a device first touching the body of the patient would be the distal end or distal end portion, while the opposite end or end portion of the device (e.g., the end or end portion of the device being manipulated by the user) would be the proximal end or proximal end portion of the device.

[0026] As used herein, the term “bio-signals” generally refers to signals associated with the body of a patient. More particularly, bio-signals generally refers to signals in or on the body of a patient and / or changes in one or more characteristics produced by one or more physiological or pathophysiological occurrences. The bio-signals can be, for example, detected or sensed by one or more sensors, which in turn, can generate one or more electric and / or electronic signals associated with and / or representative / indicative of the sensed bio-signal. The embodiments described herein generally relate to devices that are at least partially disposed in a substernal or mediastinal space of a patient and thus, in the context of such embodiments, bio-signals can, for example, include signals associated with physiologic or pathophysiologic occurrences within the substernal or mediastinal space of the patient. For example, the bio-signals can include signals and / or changes in one or more characteristics that are detectable by one or more sensors disposed within the anterior mediastinum. The bio-signals can include, for example, cardiac signals, respiratory signals, and / or the like. As used herein, the term “bio-signal” can be used interchangeably to refer to the signal or characteristic detected by a sensor in the body of a patient as well as the electric and / or electronic signal produced by the sensor that is associated with and / or representative / indicative of the underlying bio-signal, and the meaning of the term will be understood by one skilled in the art based on the context in which the term is used.

[0027] As used herein, the term “cardiac signals” generally refers to signals from one or more sensors that can include physiological or pathophysiological bio-signals from the heart. Such signals can be, for example, cardiac electrical signals or cardiac non-electrical signals. CardiacDocket No. NHAN-006 / 01WO 351645-2022electrical signals can include any suitable signals associated with and / or otherwise indicative of the electrical functioning of the heart. The measurement of such cardiac electrical signals may include, but is not limited to, heart rate, voltage, P wave, QRS morphology, ST segment, T wave, electrocardiogram (ECG) diagnosis, and / or the like, sensed through any suitable number of vectors. Cardiac non-electrical signals (also referred to herein as “cardiac mechanical signals”) can include any suitable signals associated with and / or otherwise indicative of the non-electrical (e.g., mechanical) functioning of the heart. The measurement of such cardiac mechanical signals may include, but is not limited to, pressure characteristics (e.g., blood pressure, pressure in the tissue or volumes surrounding the heart, venous pressures, arterial pressures, and / or changes in such pressures, etc.), hemodynamic characteristics, oxygen saturation, sensed mechanical heart movement, cardiac sounds, cardiac echogram (ultrasound), cardiac Doppler, and / or the like.

[0028] As used herein, the term “respiratory signals” generally refers to signal from one or more sensors that can include physiological or pathophysiological bio-signals from the respiratory system such as lungs, diaphragm, trachea, or the like. Such signals can include any suitable signals associated with and / or otherwise indicative of the functioning of the respiratory system, the measurement of respiratory signals may include and / or be associated with, but is not limited to pulmonary characteristics, respiratory rate, airway pressure, intrapleural pressure, acoustic signals, diaphragmatic function, thoracic impedance, and / or the like.

[0029] The embodiments described herein and / or portions thereof can be formed or constructed of one or more biocompatible materials. In some embodiments, the biocompatible materials can be selected based on one or more properties of the constituent material such as, for example, stiffness, toughness, durometer, bioreactivity, etc. Examples of suitable biocompatible materials include but are not necessarily limited to metals, glasses, ceramics, and / or polymers. Examples of suitable metals include pharmaceutical grade stainless steel, gold, titanium, nickel, iron, platinum, tin, chromium, copper, and / or alloys thereof. A biocompatible polymer material may be biodegradable or non-biodegradable. Examples of suitable biocompatible polymer materials can include but are not necessarily limited to polylactides, polyglycolides, polylactide-co-glycolides, polyethylene-glycols, polyanhydrides, polyorthoesters, polyetheresters, polycaprolactones, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes, polyamides (nylons), polyesters, polycarbonates, polyacrylates, polystyrenes, polypropylenes, polyethylenes, polyethylene oxide, polyolefins, polyethersulphones, polysulphones, polyvinylpyrrolidones, polyvinyl chloride, polyvinylDocket No. NHAN-006 / 01WO 351645-2022fluoride, poly(vinyl imidazole), polyether urethanes, silicone polyether urethanes, polyetheretherketones (PEEK), polytetrafluoroethylenes (PTFE), polylactones, chlorosulphonate polyolefins, ethylene-vinyl acetates and other acyl substituted cellulose acetates, elastomers, thermoplastics, and / or blends and copolymers thereof.

[0030] The embodiments, methods, and / or implementations herein, and / or the various features or advantageous details thereof, are explained more fully with reference to the non-limiting examples illustrated in the accompanying drawings and detailed in the following description. The examples and / or embodiments described herein are intended to facilitate an understanding of structures, functions, and / or aspects of the embodiments, ways in which the embodiments may be practiced, and / or to further enable those skilled in the art to practice the embodiments herein. Similarly, methods and / or ways of using or implementing the embodiments described herein are provided by way of example only and not limitation. Specific uses and / or implementations described herein are not provided to the exclusion of other uses unless the context expressly states otherwise. Descriptions of well-known components, methods, techniques, etc. may be omitted so as to not obscure the embodiments herein. Like numbers refer to like elements throughout.

[0031] FIG. 1 schematically depicts an intra-sternal diagnostic / treatment system 100 (also referred to as the system 100) engaging a patient P, according to an embodiment. The system 100, or a portion thereof, is implanted (or implantable) in the patient P via a sternum S of the patient P. The system 100 can be utilized for monitoring and / or treating certain conditions or states of the patient P. For example, the system 100 can be used for monitoring, diagnosing, and / or treatment of cardiac conditions (e.g., of a heart H) and / or states of the patient P and / or can be used for at least monitoring and / or diagnosing of respiratory conditions and / or states of the patient P.

[0032] In some embodiments, system 100 can include or be at least a portion of one or more of an implantable cardioverter defibrillator (ICD), a cardiac resynchronization therapy pacemaker (CRT-P), a cardiac resynchronization defibrillator (CRT-D), an implantable cardiac monitor, a diagnostic monitor, a cardiac loop recorder, a congestive heart failure patient monitor, a pulmonary monitor (e.g., for COPD, sleep apnea, etc.), a hemodynamic monitor, and / or any device or system configured to sense bio-signals associated with the anterior mediastinal space of the patient P.Docket No. NHAN-006 / 01WO 351645-2022

[0033] The system 100 includes an electrical device 110 operatively coupled to a lead 115. The electrical device 110 optionally includes supporting component(s) 112 and a treatment generator 114. The electrical device 110 is configured to monitor bio-signals, diagnose and / or predict a diagnosis associated with the patient, determine a health state associated with the patient, determine when or whether to provide treatment, generate treatment energy, and / or the like. The lead 115 optionally includes a sensing and / or treatment element(s) 116 (also referred to as the element(s) 116). The lead 115 is configured to sense and / or deliver treatment that is generated by the electrical device 110. The lead 115 is configured to engage the substemal space SS between the Sternum S and the heat H via one or more opening formed in the sternum S. In some embodiments, the lead 115 is configured to directly engage the heart H (e.g., into the epicardial wall or myocardium). The electrical device 110 is configured to be coupled to the lead 115 and to be implanted near the sternum, onto the sternum, into the sternum, on a pectoralis major muscle, behind the pectoral major muscle, on the abdomen, along the left exterior thorax, in a subcutaneous pocket on the chest, and / or elsewhere on or in the body of the patient P. The electrical device 110 and the lead 115 can be coupled via a portion of the lead 115 and / or wires configured to communicate signals (e.g., bio-signals or signals associated with bio-signals) and / or deliver treatment energy.

[0034] The electrical device 110 can be any suitable device or combination of devices configured to receive signals from the lead 115, monitor the signals, make a determination s), diagnosis(es), and / or prediction(s) based on the signals, provide treatment(s) based at least in part on the signals, and / or generate treatment energy that can be delivered to the heart H via the lead 115. The electrical device 110 is electrically and / or electronically coupled to the lead 115 allowing signals and / or electric energy to be transferred therebetween. For example, the electrical device 110 can receive signals from the lead 115 that include data representing measurements associated with one or more bio-signals of the patient P (e.g., respiratory signals, cardiac signals, etc.). In some implementations, for example, the electrical device 110 and the lead 115 can be similar to and / or substantially the same as the components of the systems (or portions thereof) described in International Patent Application No. PCT / US2024 / 042740 (“the ‘740 application”), filed August, 16, 2024, entitled “Systems, Devices, and Methods for Improving Decision-Making of Implantable Devices Using Multiple Data Sources,” the disclosure of which is incorporated herein by reference in its entirety. Accordingly, portions and / or aspects of the electrical device 110 and / or the lead 115 may be generally describedDocket No. NHAN-006 / 01WO 351645-2022below for context, but are not described in detail with respect to the embodiment shown in FIG.1.

[0035] The supporting component(s) 112 include one or more components configured to provide one or more function to support the desired functionality of the electrical device 110. In some embodiments, the supporting component(s) 112 can be integrally formed with the electrical device 110 and / or can be operatively coupled to the electrical device 110 via conduits, wires, and / or the like. In some embodiments, the supporting component(s) 112 can include a processor, a memory, a power system, a lead interface, and / or the like, as described, for example, in the ‘740 application. In some embodiments, one or more of the supporting components 112 can be included in the treatment generator 114.

[0036] In some embodiments, the power system is configured to store and / or generate energy for use by the electrical device 110. In some embodiments, the power system can include at least one battery (e.g., LiPo, Li-ion, etc.). The at least one battery can be charged when the battery is low on power. In some embodiments, the power system includes a primary cell battery and a rechargeable battery. In some embodiments, the power system can be configured to charge automatically (e.g., via patient P movement) or wirelessly (e.g., via inductive charging).

[0037] In some embodiments, the lead interface is configured to couple (e.g., physically couple or at least electrically couple) the electrical device 110 to the lead 115 to allow data signals and / or electric power (e.g., for therapy) to be transferred therebetween. In some embodiments, the lead interface can be configured to modify data and / or power transmitted therethrough from the lead 115 and / or from the device 110. For example, the lead interface can be configured to format data signals and / or modulate electric power transferred between the electrical device 110 and the lead 115 into any suitable format(s), waveform(s), energies, etc., allowing, for example, the processing of sensor data or the like by the electrical device 110, the generation of treatment energy, and / or the application of therapy by the lead 115. In some embodiments, the lead interface can be configured to modify data and / or power from the lead 115 prior to receipt of the data and / or power at the electrical device 110. Further, the lead interface can be configured to modify data and / or power from the electrical device 110 prior to receipt of the data and / or power at the lead 115. The lead interface may be a flexible interface to provide flexibility for the continuous movement of the heart H and / or other anatomy of the patient P. For example, the lead interface can include any number of flexible wires, interconnections, couplers, etc. configured to at least electrically couple the electrical device 110 to the lead 115,Docket No. NHAN-006 / 01WO 351645-2022while allowing for relative motion based at least in part on the dynamic nature, movement, changes, etc. associated with the anterior mediastinum.

[0038] In some embodiments, the supporting component(s) 112 can include additional sensors and / or devices for detecting, measuring, and / or determining additional characteristics associated with the patient. For example, the additional sensors can be configured to measure movement of the patient P (e.g., via an accelerometer, etc.), body position (e.g., via a gyroscope, etc.), blood oxygen saturation (e.g., via a pulse oximeter, etc.), and / or the like.

[0039] The memory of the supporting component(s) 112 can store code including instructions that when executed by the processor allow for the electrical device 110 to execute one or more action. In some embodiments, such as when the electrical device 110 is a portion of or includes the functions of an ICD, an implantable pacemaker, a CRT-P, and / or the CRT-D, the electrical device 110 can be configured to determine a diagnosis, the cardiac status, and / or functioning of the heart, which can include, for example, comparing, correlating, and synchronizing the signal data received from lead 115, as described in detail in the ‘740 application. For example, the signals can include cardiac electrical signals (e.g., electrocardiogram signals, cardiac electrogram signals, etc.) and / or cardiac mechanical signals (e.g., hemodynamic status and / or output). The electrical device 110 can receive the signal data from the lead 115 and can determine the cardiac status and further classify a cardiac condition that may be treated by the electrical device 110 (e.g., arrhythmia, tachycardia, bradycardia, post-shock arrythmia, etc.). In some embodiments, the electrical device 110 can use respiratory signals, such as pressure signals, to corroborate (e.g., confirm, correlate, verify, etc.) the cardiac electrical signal data. The electrical device 110, based on determining that treatment is desired, can be configured to select, determine, and / or define treatments for delivery to the patient P. The electrical device 110 can also be configured to, based on the cardiac signals and / or the respiratory signals, determine one or more diagnostic status (e.g., diagnosis, etc.) associated with the patient P.

[0040] The treatment generator 114 is configured to generate at least one therapy signal (e.g., cardiac pacing, defibrillator shock, etc.) based on the electrical device 110 determining that treatment is desired. For example, the treatment generator 114 can generate a therapy signal based on the type of determined type of treatment. The therapy signal can include treatment energy for at least one of cardiac pacing and / or shock therapy. In some implementations, the treatment energy for cardiac pacing can be low-power or relatively low-power treatment energy and the treatment energy for shock therapy can be high-power or relatively high-power treatment energy. In some embodiments, the operation of the treatment generator 114 isDocket No. NHAN-006 / 01WO 351645-2022controlled via a processor of the electrical device 110 executing instructions stored in a memory of the electrical device 110.

[0041] In some embodiments, such as when the electrical device 110 is a portion of and / or includes the function of a diagnostic and / or monitoring device, the electrical device 110 is configured to monitor one or more respiratory parameter and / or cardiac parameter for monitoring and / or diagnostic purposes. The electrical device 110 is configured to monitor the parameters based on bio-signals from the lead 115. For example, the electrical device 110 can be configured to monitor respiratory rate, respiratory rhythm, respiratory function, pulmonary function, hemodynamics, cardiac electrical signals, cardiac mechanical signals, and / or the like. The electrical device 110, based on the monitoring, can be configured to monitor and / or diagnose obstructive sleep apnea syndrome, respiratory diseases, lung diseases, congestive heart failure, potential decompensation, cardiac arrhythmias, COPD, and / or the like. The electrical device 110 can be used in emergency medical situations such as the ICU, post-surgical monitoring, and / or emergency medical monitoring as well as for long-term patients such as nursing home patients to monitor cardiac and / or respiratory parameters to diagnose potential issues. For example, the electrical device 110 can be at least a portion of a comprehensive life monitor for monitoring the patient P.

[0042] The electrical device 110 can be configured to be coupled to the sternum S of the patient P. For example, the electrical device 110 can be coupled to the anterior wall of the sternum S. The electrical device 110 can be coupled via one or more fasteners (e.g., screws, bolts, clips, pins, a combination of fasteners, etc.). In some embodiments, the electrical device 110 can be configured to engage one or more features (e.g., pilot holes, indents, etc.) formed in the sternum S. For example, a screw can be inserted into a pilot hole. In some embodiments, the electrical device 110 can be coupled via an adhesive (e.g., glue, epoxy, etc.). In some embodiments, the electrical device 110 can be selectively removeable from the sternum S. In some embodiments, the electrical device 110 is coupled to the sternum S so the lead 115 and / or a lead interface can extend away from the electrical device 110 into and / or through one or more opening formed in the sternum S to access the substemal space SS. Coupling at least a portion of the electrical device 110 to the sternum S can allow for a minimized distance between the lead and the electrical device 110 as well as can allow for the electrical device 110 to sense movement of the patient P body, such as physical activity, respiratory movement, and / or the like. Additionally, coupling at least a portion of the electrical device 110 to the sternum S can allow for reduced complexity, reduce latency, reduced length of exposed conduit, wire, etc. and thusDocket No. NHAN-006 / 01WO 351645-2022reduced chance of damage, reduced chance of disconnection between the electrical device 110 to the lead 115, and / or the like.

[0043] In some embodiments, the electrical device 110 can be configured to fit the shape and / or size of the sternum S. In some embodiments, a portion of the electrical device 110 can be coupled to the sternum S while another portion of the electrical device 110 can be implanted elsewhere in the body. For example, a treatment generator 114 can be coupled to the sternum S while supporting component(s) 112, such as a battery, can be implanted into a subcutaneous pocket (e.g., outside of the sternum, on the chest, by the foot of the xiphoid, etc.). The size and location of the electrical device is further shown and described in reference to FIGS. 4-5. In some embodiments, the electrical device 110 (e.g., the entire device) may be implanted in a different portion of the patient P. For example, the electrical device 110 can be implanted in a subcutaneous pocket on the chest.

[0044] The lead 115 can extend away from the electrical device 110 via a conduit, connector, tube, shaft, interface, etc., that includes one or more signal and / or power carrying wire(s). The lead 115 is configured to be disposed within the substernal space SS and more particularly, in the anterior mediastinum. The lead 115 is configured to sense bio-signals within the anterior mediastinum and / or to deliver treatment to the patient and / or to the heart H of the patient P. In some embodiments, the lead 115 is configured to be deployed and / or utilized at least partially outside of the heart H. In some implementations, the lead 115 can be configured to be at least partially implanted into a portion of the heart such as the heart wall, the pericardium, epicardium, and / or the myocardium of the heart H. For example, the lead 115 can be a pericardial lead, an epicardial lead, and / or the like (or combination thereof). In some embodiments, the lead 115 is a sensing lead configured to sense, detect, and / or measure at least one health characteristic (or bio-signal) associated with the patient P. For example, the at least one health characteristic can include cardiac parameters (e.g., cardiac electrical parameters, cardiac mechanical parameters, etc.) associated with the heart H, respiratory parameters associated with the respiratory system, and / or other health characteristics associated with the patient P. In some embodiments, the health characteristics can be associated with one or more health condition and / or health state that the system 100 is configured to monitor.

[0045] The lead 115 can include and / or be in communication with one or more of a sensing and / or a treatment element 116 (referred to as “the element(s) 116”) configured to sense health characteristics, deliver treatment(s) to the heart H, and / or combinations thereof. The element(s) 116 can include and / or function as one or more sensors. For example, the lead 115 can be inDocket No. NHAN-006 / 01WO 351645-2022communication with one or more sensors via a sensor interface and / or the like. The element(s) 116 can include multiple sensor which can be configured to measure the same characteristic for redundancy, or various sensors can be configured to measure different health characteristics of the patient P. For example, the lead 115 can include sensor similar to and / or substantially similar to those described in the ‘740 application. In such embodiments, the lead 115 can include, for example, a first sensor configured to measure cardiac electrical signals (e.g., heart rate, voltage, P wave, QRS morphology, ST segment, T wave, electrocardiogram (ECG) signals, etc.), and a second sensor configured to measure cardiac mechanical signals (e.g., hemodynamic status, hemodynamic output, blood pressure or other pressures within the body, and / or derivative(s) thereof). The element(s) 116 can also and / or alternatively include one or more sensor configured to measure respiratory signals such as pulmonary signals, thoracic signals, acoustic signals, and / or the like. In some embodiments, the element(s) 116 can include additional sensors configured to movement of the patient P, body position of the patient P, blood oxygen saturation, and / or the like. In some embodiments, the element(s) 116 are configured to measure patient P characteristics that are used to determine one or more other patient P characteristics.

[0046] The element(s) 116 can include one or more pressure sensor, transducer, and / or other element configured to detect and / or sense pressure (collectively known as pressure sensors). The element(s) 116 can include pressure sensors configured to detect and / or sense pressure, changes in pressure, hemodynamic pressure, and / or the like in the anterior mediastinum. Pressure sensors and generally detecting pressure is further described in the ‘740 application.

[0047] The element(s) 116 can be included along one or more portion of the lead 115. For example, the element(s) 116 can be at a distal tip of the lead 115 and / or anywhere between the electrical device 110 and the distal tip of the lead 115. In some embodiments, the element(s) 116 are integrated into the lead 115. In some embodiments, the element(s) 116 are remote from the lead. In some embodiments, each element(s) 116 can be configured to sense and / or detect a different characteristic associated with the heart H, the respiratory system, and / or more generally, the patient P. In some embodiments, the element(s) 116 can be configured to sense or detect the same characteristic, thereby allowing for confirmation / verification of signal data and / or a desired degree of sensitivity and / or specificity in interpreting the signal data. In some embodiments, the position off the element(s) 116 can depend based on the desired type of characteristics to be sensed. In some embodiments, the element(s) 116 are configured to couple to other portions of the lead 115 and / or the electrical device 110 via the sensor interface. InDocket No. NHAN-006 / 01WO 351645-2022some embodiments, the sensor interface can be configured to provide the element(s) 116 with power. In some embodiments, the sensor interface can be configured to preprocess signals output by and / or received from the element(s) 116. In some embodiments, the element(s) 116 are calibrated based on the patient P, the position in the body of the patient P, and / or the like. The element(s) 116 can be configured to measure continuously, periodically, or when a command is received by the element(s) 116. The signals sensed and / or detected by the element(s) 116 can be aggregated, correlated, verified, confirmed, corroborated, etc., which in turn, can be used to improve output accuracy including sensing accuracy, diagnostic accuracy, treatment accuracy (e.g., reduce undesirable, inappropriate, and / or inaccurate diagnoses, treatments, etc.), and / or the like by confirming that an indication and / or prediction of a health event, or the like, from one data source is occurring based on correlated data from other data sources.

[0048] The element(s) 116 can include any number of shocking elements, electrodes, conductors, etc. for delivering treatment (e.g., including energy from the electrical device 110) to the heart H of the patient P. In some embodiments, the lead 115 can include biased portions, loops, coils, waves, and / or any other shape, geometry, and / or feature that can aid in positioning all or a subset of the shocking elements relative to the heart H when the lead 115 is in the substernal space. In some embodiments, the lead 115 can include shocking elements, electrodes, conductors, etc. configured to deliver relatively high energy shock treatment to the heart H (e.g., for ventricular defibrillation treatment). In some embodiments, the lead 115 can include shocking elements, electrodes, conductors, etc. configured to delivery relatively low energy shock treatment to the heart H (e.g., for cardiac pacing). In some embodiments, the lead 115 can include any suitable number or combination of high energy shocking elements and / or low energy shocking elements.

[0049] In some embodiments, the element(s) 116 can be used to deliver low-energy impulses used for cardiac pacing (e.g., a method to treat dangerous arrhythmias without a defibrillation shock). As used herein, “cardiac pacing” or simply “pacing” generally refers to delivering low-energy impulses to “pace” the heart in response any suitable type of arrythmia. Examples of cardiac pacing can include, but are not limited to, anti-tachycardia pacing, bradycardia pacing, post-shock pacing, and / or the like. Anti-tachycardia pacing can include, for example, pacing shocks that provide therapy for ventricular tachycardia (e.g., a heartbeat that is faster than desired). Anti-bradycardia pacing can include, for example, pacing shocks that provide therapy for bradycardia (e.g., a heartbeat that is slower than desired). Post-shock pacing can include,Docket No. NHAN-006 / 01WO 351645-2022for example, lower energy pacing that is delivered after a higher-energy shock is delivered (e.g., to facilitate the return of the heart to a normal sinus rhythm). Thus, while specific types arrythmias and / or specific types of pacing are described herein, it should be understood that they are presented by way of example only. The embodiments and / or methods described herein, inter alia, can be used to provide cardiac pacing to treat other types of arrythmias that may not be explicitly described herein.

[0050] As described in further detail herein, the lead 115 can be delivered via one or more opening in the sternum S such that the element(s) 116 are positioned in the substemal space SS, anterior mediastinum, and / or otherwise positioned so that the element(s) 116 are implanted in desired location(s) of the patient P. The one or more openings can include one or more opening, hole, aperture, and / or the like configured to allow for at least a portion of the lead to pass through. The one or more openings can include openings that are sized and / or located to receive a desired portion of the lead 115 and / or to aid in positioning thee lead 115 in the substernal space SS. The one or more openings can be drilled, cut, and / or otherwise formed in the sternum S. In some embodiments, the one or more openings can be used for visualization of the substernal space to determine the desired locations for the lead 115. In some embodiments, the desired locations can include location that are in contact, engaging, or are in close proximity to the heart H (e.g., the fibrous pericardium) of the patient P, within the anterior mediastinum, and / or in contact, engaging, or in close proximity to one or more portion of the respiratory system.

[0051] In some embodiment, the lead 115 can include one or more markers that is visible during imaging (e.g., fluoroscopy, etc.) by an imaging device when the lead 115 is inserted into the body to aid in the positioning and / or orienting of the lead 115 into the desired locations. The markers can be used for confirming the position of the lead 115. In some embodiments, the one or more markets are radiopaque. In some embodiments, for example, the lead 115 can include one or more markers corresponding to, co-located with, and / or otherwise associated with the element(s) 116, which can aid in positioning and / or orienting the lead 115 or confirming the position and / or orientation of the lead 115 relative to the heart H, the anterior mediastinum, and / or other patient P anatomy. In some embodiments, the lead 115 can also include one or more markers corresponding to any suitable position and / or feature of the lead 115 (e.g., a distal end of the lead 115, electrode or sensor regions, physical features or geometries, etc.).Docket No. NHAN-006 / 01WO 351645-2022

[0052] FIG. 2 schematically depicts an intra-sternal diagnostic / treatment system 200 (also referred to as the system 200) (e.g., functionally and / or structurally similar to the system 100 of FIG. 1) engaging the anterior mediastinum of a patient P, according to an embodiment. The system 200 includes an electrical device 210 (e.g., functionally and / or structurally similar to the electrical device 110 of FIG. 1) and a lead 215 (e.g., functionally and / or structurally similar to the lead 115 of FIG. 1) including a sensing and / or treatment element(s) 216 (also referred to as the element(s) 216) (e.g., functionally and / or structurally similar to the element 118 of FIG.1). The system 200 is configured to access the anterior mediastinum of the patient P through one or more opening in the sternum S. As described above, the system 200 can be used for monitoring, diagnostic, and / or therapeutic purposes. The system 200 can be used to the monitor, diagnose, and / or treat the heart H, the respiratory system, and / or the like.

[0053] The system 200 is configured to be implanted into patient P after the one or more openings are formed in the sternum S. The one or more openings allow for a desired location of the lead 215 to be determined and / or for the lead 215 to be inserted into the substemal space SS. The electrical device 210 is configured to be implanted into the patient P outside of the sternum S. For example, one or more portion of the electrical device 210 can be implanted into a subcutaneous pocket. For example, the subcutaneous pocket can be on the left side of the chest, the right side of the chest, near the xiphoid, and / or the like. In some embodiments, the electrical device 210 can include portions that are included in various locations implanted into the patient P. For example, a battery can be separate from a treatment generator. In some embodiments, the electrical device 210, or at least a portion thereof, may be external to the patient P. For example, the electrical device 210 can be an external device, include an external power source, be a portion of an external device, and / or the like. For example, if the system 200 is used in an emergency medical setting, such as in an ICU, RICU, etc., the electrical device 210 can be a portion of a patient monitor and / or other medical device configured to monitor, diagnose, and / or treat the patient P.

[0054] The electrical device 210 is configured to monitor bio-signals, determine when to provide treatment, determine a state associated with the patient, and / or generate treatment energy. The electrical device 210 receives bio-signals from the lead 215 to monitor, diagnose, and / or treat the patient P. The electrical device 210, in some embodiments, is configured to analyze the bio-signals to determine if treatment (e.g., cardiac treatment) is desired and then generate treatment energy that can be sent to the lead 215 for delivery to the heart H.Docket No. NHAN-006 / 01WO 351645-2022

[0055] The lead 215 can extend away from the electrical device 210 via one or more conduit, connector, tube, shaft, etc., that includes a signal / power carrying wire. In some embodiments, the lead 215 can be connected to the electrical device 210 via more than one conduit, connector, tube, shaft, etc. For example, remote sensors, electrodes, and / or the like can each be connected to the electrical device 210 via a separate wire. The lead 215, via the element(s) 216 is configured to sense bio-signals within the anterior mediastinum and / or to deliver treatment to the patient and / or to the heart H of the patient P. In some embodiments, the lead 115, is configured to be deployed and / or utilized at least partially outside of the heart H. In some implementations, the lead 115 can be configured to be at least partially implanted into a portion of the heart such as the heart wall, the pericardium, epicardium, and / or the myocardium of the heart H.

[0056] The lead 215 is inserted into the substernal space SS via the one or more openings in the sternum S. In some embodiments, the lead 215 (e.g., the entire lead) is inserted through one opening. In some embodiments, separate portions of the lead 215 can be inserted into different openings. For example, separate sensors can be configured to be inserted into different openings based on a desired location for the sensor in the anterior mediastinum. In some embodiments, the connections between the electrical device 210 and the lead 215 may be based on the position of the electrical device 210. For example, a thinner conduit can be used between the electrical device 210 and the sternum S and a thicker conduit can be used from the sternum S into the substernal space SS. The thinner conduit can be less intrusive for a patient, while the thicker conduit can provide additional support for the lead 215 so that the element(s) 216 are positioned in a desired location. In some embodiments, a portion of the lead 215 can be coupled to the sternum S to provide support for the lead 215 in the substernal space SS.

[0057] FIG. 3 schematically depicts an intra-sternal diagnostic / treatment system 300 (also referred to as the system 300) (e.g., functionally and / or structurally similar to the system 100 of FIG. 1 and / or the system 200 of FIG. 2) including an electrical device 310 disposed on the sternum S engaging the anterior mediastinum, according to an embodiment. The system 300 includes the electrical device 310 (e.g., functionally and / or structurally similar to the electrical device 110 of FIG. 1 and / or the electrical device 210 of FIG. 2) and a lead 115 (e.g., functionally and / or structurally similar to the lead 115 of FIG. 1 and / or the lead 215 of FIG. 2) including a sensing and / or treatment element(s) 316 (also referred to as the element(s) 316) (e.g., functionally and / or structurally similar to the element 118 of FIG. 1 and / or the element(s)Docket No. NHAN-006 / 01WO 351645-2022

[0058] The system 300 is similar to the system 200, but instead includes a portion of the electrical device 310 coupled to the sternum S. In some embodiments, the electrical device 310 is coupled to the body off the sternum S. In some embodiments, the electrical device 310 is coupled to the sternum S via one or more fastener, an adhesive, and / or the like. The electrical device 310 may be positioned on the sternum so that the lead 315, which extends away from the electrical device 310, may be implanted into the substemal space SS through one or more opening in the sternum S when the electrical device 310 is coupled to the sternum S. Similarly, the position of the lead 315 extending away from the electrical device 310 may be associated with the layout of the one or more openings in the sternum S such that the lead 315 and the electrical device 310 are in desired positions in the anterior mediastinum and on the sternum S, respectively.

[0059] In some embodiments, the electrical device 310 may include or be coupled to other external and / or internal devices and / or components. For example, while the electrical device 310 may be coupled to the sternum, a battery may be implanted in a subcutaneous pocket (e.g., at the apex of the heart).

[0060] Referring generally to FIGS. 4-6, electrical devices, such as the electrical device 110 of FIG. 1, the electrical device 210 of FIG. 2, the electrical device 310 of FIG. 3, the electrical device 410 of FIG. 4, and / or the electrical device 510 of FIG. 5, are configured (e.g., sized, shaped, etc.) to be coupled to and / or implanted in a desired location. As seen in FIG. 5-6, an electrical device is sized such that the electrical device can be coupled to the sternum S of a patient P. Furthermore, and as seen in FIG. 6, the electrical device is configured to align with the anatomy of the patient so that a desired portion of the anterior mediastinum is accessed by a lead coupled to the electrical device.

[0061] FIG. 4 depicts a perspective view of an electrical device 410 (e.g., functionally and / or structurally similar to the electrical device 110 of FIG. 1, the electrical device 210 of FIG. 2, and / or the electrical device 310 of FIG. 3), according to an embodiment. The electrical device 410 shows a representative shape of any of the electrical devices described herein, but specifically, the electrical devices configured to be coupled to the sternum. The electrical device 410 is sized such that the electrical device 410 can be coupled to the sternum. For example, the size of the electrical device 410 may be no larger than the sternum. In some embodiments, the electrical device 410 can include additional feature (e.g., bolt holes, tabs, etc.) configured to aid in coupling the electrical device 410 to the sternum S and / or to engage portions of the sternum S. As seen in FIG. 4, the electrical device 410 defines a first length LI,Docket No. NHAN-006 / 01WO 351645-2022a second length L2, and a third length L3. In some embodiments, the first length LI may be no longer than the longest dimension of the body of the sternum. In some embodiments, the second length L2 may preferably be minimal to maximize patient comfort. In some embodiments, the third length L3 may be no longer than the minimum width of the body of the sternum. In some embodiments, the length LI is between about 40 mm and about 80 mm, inclusive of all ranges and values therebetween. In some embodiments, the length L2 is between about 6 mm and about 10 mm, inclusive of all ranges and values therebetween. In some embodiments, the length L3 is between about 10 mm and about 25 mm, inclusive of all ranges and values therebetween. In some embodiments, the electrical device 410, while not shown in FIG. 4, can include curved edges, curved portions, extruded portions, and / or the like that are configured to substantially correspond to the shape of the sternum. In some embodiments, the size and / or shape of the electrical device 410 is associated with which components are included in the electrical device 410 (e.g., treatment generator, power source, etc.)

[0062] FIG. 5 depicts an electrical device 510 (e.g., functionally and / or structurally similar to the electrical device 110 of FIG. 1, the electrical device 210 of FIG. 2, the electrical device 310 of FIG. 3, and / or the electrical device 410 of FIG. 4), disposed on an anterior wall of a sternum S of a patient, according to an embodiment. As seen in FIG. 5, the electrical device 510 is configured to be sized so that it fits entirely on the body of the sternum S. In some embodiments, the electrical device 510 can be configured to partially fit on the body of the sternum S. While not shown in FIG. 5, the electrical device 510 is coupled to a lead (e.g., functionally and / or structurally similar to any of the leads described herein) through one or more opening in the sternum S. When coupling to the sternum S, the lead is first inserted such that the electrical device, when coupled to the sternum S, covers the one or more opening.

[0063] In some embodiments, the electrical device 510 is operatively coupled to supporting component s) 512 (e.g., functionally and / or structurally similar to the supporting components 112 of FIG. 1). In some embodiments, the electrical device 510 can include the supporting component s) 512 internally (e.g., in the portion coupled to the sternum S). In some embodiments, the supporting component(s) 512 can be located outside of the body of the patient and / or implanted elsewhere in the body, such as subcutaneously at the chest, near the xiphoid, and / or the like. The supporting component(s) 512 can be coupled to the electrical device 510 via conduits, wires, and / or the like that are configured to transfer at least one of signals and / or energy.Docket No. NHAN-006 / 01WO 351645-2022

[0064] FIG. 6 depicts an intra-sternal diagnostic / treatment system 600 (also referred to as the system 600) (e.g., functionally and / or structurally similar to the system 100 of FIG. 1, the system 200 of FIG. 2, and / or the system 300 of FIG. 3) implanted in a patient P, according to an embodiment. The system 600 includes the electrical device 610 (e.g., functionally and / or structurally similar to the electrical device 110 of FIG. 1, the electrical device 210 of FIG. 2, the electrical device 310 of FIG. 3, the electrical device 410 of FIG. 4, and / or the electrical device 510 of FIG. 5) and a lead 615 (e.g., functionally and / or structurally similar to the lead 115 of FIG. 1, the lead 215 of FIG. 2, and / or the lead 315 of FIG. 3). A sternum S of the patient P includes an opening O which is configured to allow for a wire, conduit, lead, tube, etc. to be passed through. In some embodiments, the sternum S can include more than one opening O.

[0065] The electrical device 610 is coupled to the anterior wall of the sternum S. In some embodiments, and as shown in FIG. 6, the electrical device 610 is coupled to the body of the sternum S such that electrical device 610 is coupled below the sternal angle. In some embodiments, the location of the electrical device 610 along the sternum S is associated with a desired position of the lead 615 in the anterior mediastinum. In some embodiments, the location of the electrical device 610 along the sternum S is aligned with the opening O, such that the location of the lead 615 extending away from the electrical device 610 align with the opening O. In some embodiments, the electrical device 610 is coupled to the sternum S via one or more fastener, and adhesive, and / or the like.

[0066] The lead 615 extends away from the electrical device 610 and is configured to engage the anterior mediastinum and / or the heart H. The lead 615 extends through the opening O so that the lead 615 can position one or more sensing elements and / or treatment elements in the anterior mediastinum. In some embodiments, positioning in the anterior mediastinum increases the strength of the desired signals. In some embodiments, the decreased distance between the electrical device 610 and the lead 615 can allow for decreased signal noise associated with sensor signals measured by the lead 615. In some embodiments, the lead 615 can position one or more sensing elements and / or treatment elements in various locations in the anterior mediastinum based on a desired configuration. In some embodiments, the desired configuration is associated with what characteristics and / or conditions and / or states the electrical device 610 is monitoring, diagnosing, or treating.

[0067] FIG. 7 is a flow chart depicting a method 700 for implanting an intra-sternal diagnostic / treatment system (e.g., functionally and / or structurally similar to the system 100 of FIG. 1, the system 200 of FIG. 2, the system 300 of FIG. 3, and / or the system 600 of FIG. 6),Docket No. NHAN-006 / 01WO 351645-2022according to an embodiment. The method 700 allows for one or more components of the intra-stemal diagnostic / treatment system, such as a lead (e.g., functionally and / or structurally similar to the lead 115 of FIG. 1, the lead 215 of FIG. 2, the lead 315 of FIG. 3, and / or the lead 615 of FIG. 6), to be implanted via an intra-sternal process so that the intra-sternal diagnostic / treatment system can engage or otherwise be at least partially disposed in the anterior mediastinum to sense bio-signals of a patient and / or to deliver cardiac treatment. Intra-sternal placement of portions of the intra-sternal diagnostic / treatment system allows for accurate positioning of a lead as one or more openings in the sternum can first allow for visualization of the anterior mediastinum so that a desired location of the lead can be determined, then delivered to the anterior mediastinum via the one or more openings. The method 700 allows for improved positioning of leads for various devices (e.g., functionally and / or structurally similar to the electrical device 110 of FIG. 1, the electrical device 210 of FIG. 2, the electrical device 310 of FIG. 3, the electrical device 410 of FIG. 4, the electrical device 510 of FIG. 5, and / or the electrical device 610 of FIG. 6) for monitoring, sensing, and / or treatment of the respiratory system, the heart, and / or the like.

[0068] At 701, the method 700 includes forming at least one opening in the sternum of the patient, the at least one opening allowing access to the anterior mediastinum of the patient. The at least one opening is formed (e.g., sized, etc.) such that at least a portion of a lead (e.g., for sensing and / or delivering treatment) can be inserted into the anterior mediastinum. In some embodiments, the at least one opening is formed by a drill, a bone cutter, sternal saw, and / or a similar device. In some embodiments, after the at least one opening is formed, the bone in and / or around at least one opening is sealed, cleaned, and / or the like. Medically appropriate treatment may be applied to the opening, as needed, (e.g., bone wax, cement, and / or the like). In some embodiments, the location of the one or more openings is associated with a desired location of the lead in the anterior mediastinum. In some embodiments, the location of the one or more opening may be patient dependent. In some embodiments, the one or more opening are sized such a visualization tool (e.g., endoscope, etc.) can be inserted to allow for a visualization of the anterior mediastinum.

[0069] At 702, the method 700 optionally includes determining, based on a visualization of the heart via the at least one opening, a desired position of a lead, the lead including at least one sensor configured to sense a bio-signal within the anterior mediastinum. In some embodiments, the visualization allows a physician to determine one or more desired location of the lead, or portions of the lead based on the anatomy of the patient. For example, the desired position canDocket No. NHAN-006 / 01WO 351645-2022include engaging a portion of the heart, a specific location in the anterior mediastinum, and / or the like. In some embodiments the desired positions can include more than one desired location such as separate locations for sensing elements and treatment elements.

[0070] At 703, the method 700 includes inserting the lead through the at least one opening to the desired position in the anterior mediastinum. Once the lead is inserted through the at least one opening and / or during insertion, an imaging device can be used to determine if the lead is in a desired location. In some embodiments, the lead can include one or more marker that is visible to an imaging device can be used to aid in delivering the lead to the desired position. The desired position of the lead allows for the lead to delivery energy to the heart and / or to sense one or more bio-signal associated with the cardiac system and / or the respiratory system, depending on what is desired. In some embodiments, inserting the lead includes inserting the lead into the heart wall of the heart.

[0071] At 704, the method 700 includes disposing an electrical device in one or an anterior wall of the sternum or a subcutaneous pocket, the electrical device coupled to the lead via at least one opening defined in the sternum, the electrical device configured to receive, from the lead, data associated with the bio-signal and at least one of determine a health status or generate energy associated with cardiac treatment for delivery via the lead. In some embodiments, the electrical device is surgically implanted.

[0072] When the electrical device is disposed on the anterior wall of the sternum, the electrical device can be coupled to the sternum via one or more fastener and / or an adhesive, such as in 705. The electrical device can be positioned on the sternum such that the electrical device is at least partially aligned with the one or more opening through which the lead was connected, allowing for the portions of the lead that couple to the electrical device to pass through the opening. When the electrical device is disposed in a subcutaneous pocket, the electrical device is operatively coupled to the lead via wires, conduits, and / or the like which may be subcutaneously implanted. Signals such as bio-signals and / or treatment energy are configured to be transmitted between the electrical device and the lead once implanted into the body of the patient. In some embodiments, the electrical device can be a portion of or be external to the body of the patient.

[0073] At 706, the method 700 optionally includes monitoring, by the electrical device, the bio-signal. The electrical device is configured to receive the bio-signal from the lead. In some embodiments, the electrical device is configured to process the bio-signal to determine one orDocket No. NHAN-006 / 01WO 351645-2022more characteristics, states, and / or conditions associated with the patient. In some embodiments, the electrical device can be a cardiac loop recorder for the detection of cardiac arrhythmias, a monitor for congestive heart failure patients, a pulmonary monitor (e.g., for sleep apnea, COPD, etc.), hemodynamic monitor based on cardiac electrical parameters and pulmonary monitoring, comprehensive monitor (e.g., at home, in a hospital, in an ICU, etc.), an emergency medical monitor, nursing home monitor, ICD, implantable pacemaker, CRT, and / or the like. In some embodiments, the electrical device can be configured to measure additional bio-signals such as patient motion, patient orientation, and / or the like. The electrical device can be configured to process, filter, and / or the like the bio-signals from the lead based on the additional bio-signals. In some embodiments, the electrical device can determine if a health event is occurring, such has a tachycardic, arrhythmia, and / or the like based on the biosignals. If a health event is occurring, the electrical device can determine a treatment type as well as various other parameters associated with the treatment, based on the bio-signals.

[0074] At 707, the method 700 optionally includes delivering, by the lead based on a determination that cardiac treatment is desired, treatment to the heart. The treatment is generated by the electrical device, based on the electrical device determining that treatment is desired for a health event. Once the treatment is generated and delivered to the heart via the lead, the method may return to 706 to continue monitoring the bio-signals as to determine if treatment was successful and / or to determine if further treatment is desired.

[0075] While various schematics, embodiments, and / or implementations have been described above, it should be understood that they have been presented by way of example only, and not limitation. Various modifications, changes, and / or variations in form and / or detail may be made without departing from the scope of the disclosure and / or without altering the function and / or advantages thereof unless expressly stated otherwise. Likewise, while embodiments and / or features, components, configurations, aspects, etc. thereof may be described above in the context of certain implementations, it should be understood that such implementations are presented by way of example only and not limitation. Any of the embodiments and / or features, components, configurations, aspects, etc. thereof can be used in, and / or adapted for use in, other implementations unless expressly stated otherwise. Functionally equivalent embodiments, implementations, and / or methods, in addition to those described herein, will be apparent to those skilled in the art from the foregoing descriptions and are intended to fall within the scope of the disclosure.Docket No. NHAN-006 / 01WO 351645-2022

[0076] Where schematics, embodiments, and / or implementations described above indicate certain components arranged in certain orientations, configurations, or positions, the arrangement of components may be modified. Although various embodiments have been described as having particular features, configurations, and / or combinations of components, other embodiments are possible having a combination of any features, configurations, and / or components from any of embodiments described herein, except mutually exclusive combinations. The embodiments described herein can include various combinations and / or sub-combinations of the functions, components, configurations, and / or features of the different embodiments described.

[0077] The specific configurations of the various components can also be varied. For example, the size and specific shape of the various components can be different from the embodiments shown, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected for a desired or intended usage. Thus, it should be understood that the size, shape, and / or arrangement of the embodiments and / or components thereof can be adapted for a given use unless the context explicitly states otherwise.

[0078] Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process, when possible, as well as performed sequentially as described above. While methods have been described as having particular steps and / or combinations of steps, other methods are possible having a combination of any steps from any of methods described herein, except mutually exclusive combinations and / or unless the context clearly states otherwise.

Claims

Docket No. NHAN-006 / 01WO 351645-2022What is claimed is:

1. An implantable electrical system, comprising:a lead configured to be disposed in an anterior mediastinum of a patient, the lead including at least one sensor configured to sense a bio-signal within the anterior mediastinum; andan electrical device disposed on an anterior side of a sternum of the patient, the electrical device coupled to the lead via at least one opening defined in the sternum, the electrical device configured to receive, from the lead, data associated with the bio-signal and at least one of determine a health status of the patient or generate energy associated with cardiac treatment for delivery via the lead.

2. The implantable electrical system of claim 1, wherein the electrical device is an implantable defibrillator, pacemaker, cardiac monitor, respiratory monitor, hemodynamic monitor, or vital parameters monitor.

3. The implantable electrical system of claim 1, wherein the electrical device is configured to monitor at least one respiratory parameter.

4. The implantable electrical system of claim 1, wherein the lead includes at least one of a sensor, an electrode, or a shock coil.

5. The implantable electrical system of claim 1, wherein at least a portion of the electrical device is configured to be aligned with the at least one opening.

6. The implantable electrical system of claim 1, wherein the electrical device is configured to be coupled to an anterior wall of the sternum.

7. The implantable electrical system of claim 6, wherein the electrical device is configured to be coupled to the sternum via one or more fastener.

8. The implantable electrical system of claim 1, wherein at least a portion of the electrical device is implanted into a subcutaneous pocket on a chest of the patient.Docket No. NHAN-006 / 01WO 351645-20229. The implantable electrical system of claim 1, wherein the lead is configured to engage a pericardial wall of a heart of the patient or to be at least partially implanted in at least one of an epicardium of the heart or a myocardium of the heart.

10. The implantable electrical system of claim 1, wherein the electrical device is configured to measure at least one of movement, body position, blood oxygen saturation, cardiac function, or respiratory function.

11. An implantable electrical system, comprising:a lead configured to be disposed in an anterior mediastinum of a patient, the lead including at least one sensor configured to sense a bio-signal within the anterior mediastinum;an electrical device configured to be disposed on an anterior side of a sternum of the patient; andan interface configured to extend through the sternum, the interface configured to electrically couple the lead and the electrical device,wherein the electrical device is configured to receive, from the lead via the interface, data associated with the bio-signal and at least one of determine a health status of the patient or generate energy associated with cardiac treatment for delivery via the lead.

12. The implantable electrical system of claim 11, wherein the interface is configured to modify the data from the lead prior to receipt of the data at the electrical device.

13. The implantable electrical system of claim 11, wherein the interface is configured to modulate power transferred between the electrical device and the lead.

14. The implantable electrical system of claim 11, wherein the lead is configured to engage a pericardial wall of a heart of the patient or to be at least partially implanted in at least one of an epicardium of the heart or a myocardium of the heart.

15. The implantable electrical system of claim 11, wherein the electrical device is configured to measure at least one of movement, body position, blood oxygen saturation, cardiac function, or respiratory function.Docket No. NHAN-006 / 01WO 351645-202216. The implantable electrical system of claim 11, wherein the interface is configured to extend through at least one opening defined in the sternum.

17. A method, comprising:forming at least one opening in a sternum of a patient, the at least one opening allowing access to an anterior mediastinum of the patient;inserting a lead through the at least one opening to a desired position in the anterior mediastinum, the lead including at least one sensor configured to sense a bio-signal within the anterior mediastinum; anddisposing an electrical device in one of on an anterior wall of the sternum or a subcutaneous pocket, the electrical device coupled to the lead via at least one opening defined in the sternum, the electrical device configured to receive, from the lead, data associated with the bio-signal and at least one of determine a health status of the patient or generate energy associated with cardiac treatment for delivery via the lead.

18. The method of claim 17, further comprising:coupling the electrical device to the anterior wall of the sternum if the electrical device is disposed on the anterior wall.

19. The method of claim 18, wherein the electrical device is coupled to the anterior wall via one or more fastener.

20. The method of claim 17, further comprising:determining, based on a visualization of a heart of the patient via the at least one opening, the desired position of the lead.

21. The method of claim 17, wherein the bio-signal can include at least one of a cardiac signal or a respiratory signal.

22. The method of claim 17, wherein the bio-signal is associated with a change in pressure within the anterior mediastinum.

23. The method of claim 17, further comprising:Docket No. NHAN-006 / 01WO 351645-2022delivering, by the lead based on a determination that cardiac treatment is desired, treatment to a heart of the patient.

24. The method of claim 17, wherein the lead includes at least one of a sensor, an electrode, or a shock coil.

25. The method of claim 17, wherein the electrical device is an implantable defibrillator, pacemaker, cardiac monitor, pulmonary monitor, hemodynamic monitor, or vital parameters monitor.

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